Abstract: A method of depositing of a film on a substrate with controlled adhesion. The method comprises depositing the film including metal, wherein the metal is deposited on the substrate using physical vapor deposition at a pressure that achieves a pre-determined adhesion of the film to the substrate. The pre-determined adhesion allows processing of the film into a device while the film is adhered to the substrate but also allows removal of the device from the substrate.

Abstract: A liner associated with an adhesive skin patch of a physiological characteristic sensor deployed with a sensor inserter having a housing with a removable cover includes a surface to couple to the adhesive skin patch. The liner includes a removal portion to couple the liner to the removable cover of the sensor inserter such that a separation of the removable cover from the housing removes the liner from the adhesive skin patch.

Abstract: Embodiments of the invention provide multilayer analyte sensors having material layers (e.g. high-density amine layers) and/or configurations of material layers that function to enhance 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: The invention disclosed herein includes amperometric glucose sensors having electrodes formed from processes that electrodeposit platinum black in a manner that produces relatively smooth three dimensional metal architectures, ones that contribute to sensor reliability and stability. Embodiments of the invention provide analyte sensors having such uniform electrode architectures as well as methods for making and using these sensor electrodes. A number of working embodiments of the invention are shown to be useful in amperometric glucose sensors worn by diabetic individuals.

Abstract: Disclosed herein is a fluid infusion device of the type that delivers medication fluid to the body of a patient. The device includes or cooperates with a fluid reservoir, and the device has a sealing assembly to receive and form a fluid seal with the fluid reservoir. A retractable sealing element surrounding a hollow fluid delivery needle may be used to seal a port of the fluid reservoir. The port may include a pressure vent that is sealed by the retractable sealing element. In one variation, the reservoir includes a moving valve sleeve that holds a septum. The septum moves to allow the reservoir to vent, and to form a seal with the port when the needle pierces the septum. In another variation, the device includes a needleless sealing assembly. In yet other variations, the device uses a needled fluid reservoir.

Abstract: The invention disclosed herein includes electrode compositions formed from processes that sputter metal in a manner that produces pillar architectures. Embodiments of the invention can be used in analyte sensors having such electrode architectures as well as methods for making and using these sensor electrodes. A number of working embodiments of the invention are shown to be useful in amperometric glucose sensors worn by diabetic individuals. However, the metal pillar structures have wide ranging applicability and should increase surface area and decrease charge density for catalyst layers or electrodes used with sensing, power generation, recording, and stimulation, in vitro and/or in the body, or outside the body.

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 poly(vinyl alcohol) (PVA) polymers crosslinked by an acid crosslinker, wherein the crosslinker is a dicarboxylic acid type monomer or a polymer comprising a carboxylic acid group; 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: Infusion devices, systems and related methods of autonomously delivering fluid to a patient are disclosed. One method involves monitoring a current operational context during autonomous operation of the infusion device to deliver fluid to a patient in accordance with an operating mode using an initial value for a control parameter, and in response to identifying an adjusted value for the control parameter associated with the current operational context, autonomously operating the infusion device to deliver the fluid to the patient in accordance with the operating mode using the adjusted value for the control parameter in lieu of the initial value and thereafter reverting the control parameter to the initial value.

Abstract: Activity monitoring systems and methods are disclosed. Systems include a continuous glucose monitoring device for a user including a glucose sensor for monitoring blood glucose levels of the user during an activity. An activity monitoring device is associated with the user and includes an activity sensor for tracking movement of the user during the activity. A display device is associable with the user during the activity.

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 storing alert configuration information for the user, identifying an alert condition while operating the infusion device to deliver the fluid based at least in part on the alert configuration information for the user, and in response to identifying the alert condition, providing a user notification in accordance with the user's stored alert configuration information.

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 analyte sensor apparatus including a sensing portion including one or more electrodes including a working electrode and one or more contacts for electrically connecting the sensor portion to control circuitry (e.g., a printed circuit board assembly, PCBA); and a circuit comprising the one or more contacts; wherein the circuit detects an electrical connection between the control circuitry without requiring exposure of the sensing portion to a fluid.

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 polymer composition having carbonate and aromatic isocyanate chains, a composition observed to provide such membranes with improved material properties such as enhanced thermal and hydrolytic stability.

Abstract: Infusion devices and related medical devices, patient data management systems, and methods are provided for monitoring a physiological condition of a patient. An exemplary method of monitoring a physiological condition of a patient involves obtaining current measurement data for the physiological condition of the patient provided by a sensing arrangement, obtaining a user input indicative of one or more future events associated with the patient, and in response to the user input, determining a prediction of the physiological condition of the patient in the future based at least in part on the current measurement data and the one or more future events using one or more prediction models associated with the patient, and displaying a graphical representation of the prediction on a display device.

Abstract: A sensor introducer for a physiological characteristic sensor assembly includes a sensor introducer body that includes an outer housing that defines an opening to receive the physiological characteristic sensor assembly and an inner housing surrounded by the outer housing. The sensor introducer includes a cradle movable relative to the inner housing from a first position to a second position to deploy the physiological characteristic sensor assembly. The cradle has a cradle flange to receive the physiological characteristic sensor assembly and a cradle body that receives a needle assembly. The cradle body includes at least one locking projection that engages the inner housing to inhibit the movement of the cradle relative to the inner housing in the first position and the at least one locking projection is movable relative to the inner housing to enable the cradle to move from the first position to the second position.

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: Infusion systems, infusion devices, and related operating methods are provided. A method of operating an infusion device involves determining a reference insulin absorption curve for the patient based at least in part on demographic data associated with the patient, determining a contextual adjustment factor based at least in part on a current patient context, calculating an adjusted insulin absorption curve for the patient as a function of the reference insulin absorption curve and the contextual adjustment factor, and determining a bolus dosage of the insulin based at least in part on the adjusted insulin absorption curve.

Abstract: Apparatuses and methods for identifying an infusate in a reservoir of an infusion device and systems for use in filling fluid delivery devices are provided. An exemplary apparatus for identifying an infusate in a reservoir of an infusion device includes a chamber in selective fluid communication with the reservoir. Further, the apparatus includes an indicator located in the chamber. The indicator exhibits a visual change when contacted by an infusate. The apparatus also includes a detector arrangement to identify the infusate by detecting the visual change in the indicator. An exemplary detector arrangement may include a camera to capture an image of the infusate and indicator in the chamber, and an identifier element to compare image data to a library of stored image data.

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: Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of alerting a user associated with an infusion device delivering fluid to the body of the user involves obtaining a measurement value for a physiological condition being influenced by the fluid, obtaining a current amount of active fluid in the body of the user, determining a homeostasis metric based at least in part on the current amount of active fluid and the measurement value for the physiological condition, and generating an alert based at least in part on the homeostasis metric.