Abstract: Infusion systems, infusion devices, and related operating methods are provided. An exemplary method involves operating an infusion device to deliver fluid to a user in accordance with a first operating mode of a plurality of operating modes, obtaining operational information pertaining to the first operating mode, and obtaining clinical information pertaining to the user. A destination operating mode of the plurality of operating modes is determined based at least in part on the operational information and the clinical information, and the infusion device is operated to deliver the fluid in accordance with the destination operating mode in a manner that is influenced by at least a portion of the operational information pertaining to the first operating mode.

Abstract: An insertion set system includes a base configured to be secured to a patient, and a flexible tubing on the base. The flexible tubing has a distal end portion forming a cannula to be inserted into the patient. An inserter having a needle is received by the base. The needle has a channel in which the distal end portion of the flexible tubing is received. The needle is able to slide relative to the flexible tubing, to selectively withdraw the needle off of the distal end portion of the flexible tubing. The base may include a passage for fluid flow arranged transverse to the axial dimension of the distal end portion of the flexible tubing.

Abstract: The invention disclosed herein includes sensors having three dimensional configurations that allow expansive “360°” sensing (i.e. sensing analyte from multiple directions) in the environments in which such sensors are disposed. Embodiments of the invention provide analyte sensors having foldable substrates adapted to produce optimized configurations of electrode elements 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: Analyte sensors and methods for fabricating analyte sensors and analyte sensing layers are presented here. In accordance with certain embodiments, a method for fabricating an analyte sensor includes providing a base layer and forming a conductive layer over the base layer. Further, the method includes forming an analyte sensing layer disposed over the conductive layer. The analyte sensing layer includes glucose oxidase entrapped within a thermally-cured polymer matrix and within a UV-cured polymer matrix.

Abstract: Apparatus are provided for medical devices and related operating systems and methods. An exemplary medical device includes a motor, one or more data storage elements to maintain control information, and a control module coupled to the motor and the one or more data storage elements. The control module is configured to obtain updated control information via a peer-to-peer communication session over a network, store the updated control information in the one or more data storage elements, and thereafter operate the motor based at least in part on the updated control information.

Abstract: A glucose biosensor encasement includes a first membrane and a second membrane. The first membrane has a first interlocking segment. The second membrane has a second interlocking segment cooperating with the first interlocking segment of the first membrane to provide a cavity between the first membrane and the second membrane configured to receive a glucose sensor. At least one of the first membrane and the second membrane comprises a semi-permeable portion configured to regulate diffusion characteristics of glucose through the membrane to realize a sensitivity for a sensor in the cavity. A method is also provided.

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 querying a database involves receiving an input query from a client device, identifying a logical layer of a plurality of different logical layers of the database for searching based at least in part on the input query, generating a query statement for searching the identified logical layer of the plurality of different logical layers of the database based at least in part on the input query, querying the identified logical layer of the database using the query statement to obtain result data, and providing a search result influenced by the result data.

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: 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: This disclosure includes an apparatus 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: Ambulatory infusion pumps, pump assemblies, and baseplate assemblies, including cartridges, baseplates, cannulas, inserters, and related components and batteries therefor, as well as component combinations and related methods.

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 determining a current value for a physiological condition of the user influenced by the fluid violates a first threshold value, determining a predicted value for the physiological condition of the user violates a second threshold value, and automatically altering operation of the infusion device to modify delivery of the fluid to the user after determining the predicted value violates the second threshold value when the current value violates the first threshold value.

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: Embodiments of the invention described herein include low cost infusion devices having basal and/or bolus fluid delivery options. Embodiments of the device include a housing, a reservoir to contain the fluid, a source of pressure to exert a force to expel the fluid contained in the reservoir, a bolus port adapted to receive an optional extra dose of fluid, and a cannula in fluid communication with the reservoir and the bolus port. The cannula is adapted for insertion into the user's skin for delivery of the fluid to the user's body. The device can provide a continuous delivery of the fluid along a first fluid flow path from the reservoir to the cannula and the optional extra dose of fluid along a second fluid flow path from the bolus port to the cannula.

Abstract: Embodiments of the invention provide compositions useful in implantable devices such as analyte sensors as well as methods for making and using such compositions and devices. In typical embodiments of the invention, the device is a glucose sensor comprising a polymeric composition that includes amounts of one or more immunosuppressant agents so as to provide such membranes with improved material properties such as enhanced biocompatibility.

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: 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: 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: A method for determining a volume of fluid dispensed into a test housing includes creating an electrical potential across at least one input electrode of a plurality of input electrodes and at least one output electrode of a plurality of output electrodes. The input electrodes and the output electrodes are each coupled to the test housing. The method includes receiving at least one signal from the at least one output electrode based on the fluid dispensed into the test housing. The method includes calculating the volume of fluid dispensed into the test housing based on the at least one signal received from the at least one output electrode, a dimension associated with an internal channel defined within the test housing, and a distance between two input electrodes of the plurality of input electrodes.

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.