Abstract: Embodiments of the invention provide constellations of elements useful in glucose sensors as well as methods for making and using such glucose sensors. In typical embodiments of the invention, the sensor is a glucose sensor for diabetics that comprises an analyte sensing membrane formed from a layered stack of material that includes a cellobiose dehydrogenase enzyme composition disposed over an electrode that is further coated with an analyte modulating layer formed from a cellulose acetate composition.

Abstract: A physiological characteristic sensor assembly includes a flexible top housing including a needle port having a central opening, and a flexible lower housing defining a sensor bore through the lower housing, the sensor bore coaxial with the central opening of the needle port. The physiological characteristic sensor assembly also includes an electrical subsystem disposed between the top housing and the lower housing. The electrical subsystem includes a flexible printed circuit board having a sensor contact pad, a physiological characteristic sensor and an electrically conductive adhesive patch. The physiological characteristic sensor has a distal end that extends through the needle port and a proximal end that includes at least one electrical contact. The conductive adhesive patch electrically and physically couples the at least one electrical contact of the physiological characteristic sensor to the sensor contact pad of the flexible printed circuit board.

Abstract: The invention includes method and materials designed to measure the material properties (e.g. thickness) of layers of material in a sensor using non-Faradaic EIS (Electrochemical Impedance Spectroscopy) methods. The methods are non-destructive, very sensitive and rapid. Typically in these methods, an AC voltage is applied to the desired material layer while the output current and therefore impedance is measured. This voltage can be applied in multiple frequencies in sweep mode in order to detect both the material and, for example, the thickness of the target material. In this way, EIS allows the characterization of properties of various layers of material disposed in devices such as electrochemical glucose sensors.

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 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: 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 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 are methods, apparatuses, etc. for calibrating glucose monitoring sensors and/or insulin delivery systems. In certain example embodiments, blood glucose reference samples may be correlated with sensor measurements with regard to a delay associated with the sensor measurements. In certain other example embodiments, a blood-glucose concentration in a patient may be determined based, at least in part, on one or more probability models, one or more functions for estimating blood-glucose concentrations, and/or blood glucose reference sample-sensor measurement pairs.

Abstract: Ambulatory infusion pumps, cannula insertion mechanisms, and medicament sealing assemblies, including cannula seal assemblies, plus related components, as well as component combinations and related methods.

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: A modular external infusion device that controls the rate a fluid is infused into an individual's body, which includes a first module and a second module. More particularly, the first module may be a pumping module that delivers a fluid, such as a medication, to a patient while the second module may be a programming module that allows a user to select pump flow commands. The second module is removably attachable to the first module.

Abstract: A single, optimal, fused sensor glucose value may be calculated based on respective sensor glucose values of a plurality of redundant working electrodes (WEs) of a glucose sensor. Respective electrochemical impedance spectroscopy (EIS) procedures may be performed for each of the WEs to obtain values of membrane resistance (Rmem) for each WE. A noise value and a calibration factor (CF) value may be calculated for each WE, and respective fusion weights may be calculated for Rmem, noise, and CF for each WE. An overall fusion weight may then be calculated based on the WE's Rmem fusion weight, noise fusion weight, and CF fusion weight, such that a single, optimal, fused sensor glucose value may be calculated based on the respective overall fusion weight and sensor glucose value of each of the plurality of redundant working electrodes.

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: 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: 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: 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: 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.