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: Analyte sensors and methods for fabricating analyte sensors are provided. In an exemplary embodiment, a method for fabricating a planar flexible analyte sensor includes sputtering platinum onto a polyester base layer to form a layer of platinum. The method includes patterning the layer of platinum to form working electrodes and additional electrodes. Further, the method includes forming an insulating dielectric layer over the base layer, wherein the insulating dielectric layer is formed with openings exposing portions of the working electrodes and portions of the additional electrodes. Also, the method includes partially singulating individual sensors from the base layer, wherein each individual sensor is connected to the base layer by a tab. The method further includes depositing an enzyme layer over the exposed portions of the working electrodes and coating the working electrodes with a glucose limiting membrane.

Abstract: An apparatus is provided for detecting mating of a cap with a fluid delivery device having a housing, a receptacle, and a sensor. The housing is configured to carry an insulin delivery device having a reservoir of the fluid. The receptacle is provided by the housing having a coupling with a locking recess configured to receive a cap with a sprung locking arm. The pressure sensor is carried by the receptacle proximate the coupling and configured to detect engagement force of the sprung locking arm with the receptacle when mated with the housing. A method is also provided.

Abstract: A medical device includes a first housing portion (FHP) and a second housing portion (SHP) configured to be to be movable relative to each other from a first position to operatively engage at a second position to couple at least one of a drive device and a needle-inserting device supported by one of the FHP and the SHP to a reservoir supported by the other of the FHP and the SHP. Electronic circuitry configured to detect at least one of a first magnetic interaction between a magnet and at least one of a first magnetically attractive material and a first magnet-responsive device and a second magnetic interaction between the magnet and at least one of a second magnetically attractive material and a second magnet-responsive device, and to provide a signal or a change in state in response to detecting at least one of the interactions.

Abstract: Medical devices and related patient management systems and methods are provided. A method of presenting information pertaining to operation of a medical device involves obtaining historical glucose measurement data for a patient from a database, identifying, based on the historical glucose measurement data, a first set of event patterns within respective ones of a plurality of monitoring periods, obtaining an adjusted set of glucose measurement data determined based on the historical glucose measurement data and an uncertainty metric associated with the historical glucose measurement data, identifying, based on the adjusted set of glucose measurement data, one or more event patterns within respective ones of the plurality of monitoring periods, and generating a graphical user interface display comprising an event detection region based at least in part on the first plurality and the one or more sets of event patterns.

Abstract: Electromechanical actuation systems and related operating methods are provided. A method of controlling an electromechanical actuator in response to an input command signal at an input terminal involves determining a commanded actuation state value based on a characteristic of the input command signal, generating driver command signals based on the commanded actuation state value and an actuator type associated with the electromechanical actuator, and operating driver circuitry in accordance with the driver command signals to provide output signals at output terminals coupled to the electromechanical actuator.

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: Gesture-informed patient management systems and related medical devices and operating methods are provided. A method of assisting operation of a medical device using a sensing arrangement capable of detecting physical movement by a user involves detecting a configuration procedure performed by the user in response to output of the sensing arrangement indicative of one or more gestures with respect to the medical device by the user, determining a current state of the user within the configuration procedure based at least in part on the one or more gestures with respect to the medical device relative to a sequence of gestures corresponding to a defined sequence of tasks for the configuration procedure, and providing a graphical user interface display on a client device comprising guidance information influenced by the current state within the configuration procedure.

Abstract: Medical devices and related patient management systems and parameter modeling methods are provided. An exemplary method of operating a sensing device associated with a patient involves obtaining current operational context information associated with the sensing device, obtaining a parameter model associated with the patient, calculating a current parameter value based on the parameter model and the current operational context information, obtaining one or more signals from a sensing element configured to measure a condition in a body of the patient, and providing an output that is influenced by the calculated current parameter value and the one or more signals.

Abstract: Systems, devices, and techniques are disclosed for administering and tracking medicine to patients and providing health management capabilities for patients and caregivers. In some aspects, a system includes an injection pen device including a dose setting mechanism, a dispensing mechanism, and an electronics unit to generate dose data associated with a dispensing event of a dose of the medicine dispensed from the injection pen device and time data associated with the dispensing event; a mobile device in wireless communication to receive and process the dose data; and a software application configured to determine a recommended dose based on health data and contextual data associated with a user of the injection pen device, the software application including a learning dose calculator module to adaptively calculate the recommended dose of the medicine based on time-relevant and circumstances-relevant data specific to the user of the injection pen device.

Abstract: An ambulatory infusing device including a housing, a reservoir defining an interior volume, a wall associated with the housing and having an inner surface that faces into the reservoir interior volume, and a filter assembly. The filter assembly may include a filter assembly housing with a housing filter portion having a free end associated with the inner surface of the wall and a filter supporting volume that extends to the free end of the housing filter portion, and a filter located within the filter supporting volume that extends to at least the free end of the housing filter portion.

Abstract: Embodiments of the invention provide methods and materials for making analyte sensors having a plurality of layered elements such as amperometric glucose sensors that are used by diabetic individuals to monitor blood sugar concentrations. Embodiments of the invention utilize plasma deposition technologies to form thin films of hexamethyldisiloxane useful in such sensors. Sensors that incorporate the thin film compositions formed by these processes exhibit a number of desirable characteristics.

Abstract: A continuous glucose monitoring system may employ complex redundancy to take operational advantage of disparate characteristics of two or more dissimilar, or non-identical, sensors, including, e.g., characteristics relating to hydration, stabilization, and durability of such sensors. Fusion algorithms, Electrochemical Impedance Spectroscopy (EIS), and advanced Application Specific Integrated Circuits (ASICs) may be used to implement use of such redundant glucose sensors, devices, and sensor systems in such a way as to bridge the gaps between fast start-up, sensor longevity, and accuracy of calibration-free algorithms. Systems, devices, and algorithms are described for achieving a long-wear and reliable sensor which also minimizes, or eliminates, the need for BG calibration, thereby providing a calibration-free, or near calibration-free, sensor.

Abstract: An ambulatory infusing device including a housing, a reservoir defining an interior volume, a wall associated with the housing and having an inner surface that faces into the reservoir interior volume, and a filter assembly. The filter assembly may include a filter assembly housing with a housing filter portion having a filter supporting volume, a filter located within the filter supporting volume, and a bubble guard, including a bubble guard wall and at least one bubble guard aperture that extends through the bubble guard wall, associated with the filter assembly housing such that the bubble guard wall is located in spaced relation to the filter.

Abstract: Medical devices critical to patient health and safety that communicate with third party hardware and software, such as smart devices, require validation to ensure compatibility and correct performance. Disclosed are methods and systems to perform a self-validation of hardware and/or software components with a medical device to confirm that any combination of hardware and software are compatible and perform acceptably. If the self-validation passes then the user may safely use the system, and it may report to a cloud server that the particular configuration tested was successful. If the self-validation fails, the user will be prevented from using safety-critical aspects of the application and be notified of the incompatibility; and the results may also be reported to a cloud server.

Abstract: A pump clip and a fluid infusion device system, in which the pump clip includes a mount to be connectable to a fluid infusion device, and a base coupled to the mount. The base is pivotable relative to the mount about a first pivot axis. The pump clip includes a clip coupled to the base. The clip is pivotable relative to the base about a second pivot axis, and the clip defines at least one tube clamp to receive a tube associated with the fluid infusion device.

Abstract: Sensors and methods for manufacturing sensors are provided. An exemplary method for manufacturing a sensor includes forming an electrode lead pattern over an insulator base substrate. Further, the method includes forming a structural backing layer over the electrode lead pattern and insulator base substrate. Also, the method includes performing a cutting process to cut through the structural backing layer to form a structural backing over the electrode lead pattern.

Abstract: A continuous glucose monitoring system may utilize externally sourced information regarding the physiological state and ambient environment of its user for externally calibrating sensor glucose measurements. Externally sourced factory calibration information may be utilized, where the information is generated by comparing metrics obtained from the data used to generate the sensor's glucose sensing algorithm to similar data obtained from each batch of sensors to be used with the algorithm in the future. The output sensor glucose value of a glucose sensor may also be estimated by analytically optimizing input sensor signals to accurately correct for changes in sensitivity, run-in time, glucose current dips, and other variable sensor wear effects.

Abstract: A product allows gaseous manufacturing by-products to be vented from the inside a sealed package tray. An exemplary method for packaging a device includes sealing the device inside a package tray with a gas-permeable sealing material, resulting in a sealed package tray. The sealing material allows volatile substances to vent from inside the sealed package tray to outside the sealed package tray.

Abstract: Electrochemical impedance spectroscopy (EIS) may be used in conjunction with continuous glucose monitoring (CGM) to enable identification of valid and reliable sensor data, as well implementation of Smart Calibration algorithms.