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: Fluid injection devices and related systems and operating methods are provided. An exemplary injection device includes an actuation arrangement to facilitate delivering fluid from a container, a user interface element coupled to the actuation arrangement, a data storage element to maintain one or more patient-specific parameter values and historical bolus data, and a control module coupled to the actuation arrangement and the data storage element. The control module of the injection device determines a bolus amount of the fluid to be delivered based at least in part on the one or more patient-specific parameter values and the historical bolus data in response to receiving a user input indicative of a desire to administer a bolus, and the control module configures the actuation arrangement to automatically deliver the bolus amount in response to manual actuation of the user interface element.

Abstract: A diagnostic Electrochemical Impedance Spectroscopy (EIS) procedure is applied to measure values of impedance-related parameters for one or more sensing electrodes. The parameters may include real impedance, imaginary impedance, impedance magnitude, and/or phase angle. The measured values of the impedance-related parameters are then used in performing sensor diagnostics, calculating a highly-reliable fused sensor glucose value based on signals from a plurality of redundant sensing electrodes, calibrating sensors, detecting interferents within close proximity of one or more sensing electrodes, and testing surface area characteristics of electroplated electrodes. Advantageously, impedance-related parameters can be defined that are substantially glucose-independent over specific ranges of frequencies. An Application Specific Integrated Circuit (ASIC) enables implementation of the EIS-based diagnostics, fusion algorithms, and other processes based on measurement of EIS-based parameters.

Abstract: A medical device system and related method of automatically adjusting parameters of an insulin delivery controller of an insulin infusion device are disclosed. The methodology obtains therapy-related data associated with operation of the insulin infusion device for a number of days in the past, including sensor glucose data associated with glucose levels of the user, and meal data associated with identified meals. The obtained therapy-related data is processed to generate a suitable pharmacokinetic/pharmacodynamic (PK/PD) model of the user, wherein the PK/PD model fits at least some of the sensor glucose data obtained for the user. The PK/PD model can be used to calculate at least one adjusted parameter of the insulin delivery controller, based on additional therapy-related data associated with further operation of the insulin infusion device. The insulin delivery controller can be instructed or controlled to adjust its settings in accordance with the model-calculated parameters.

Abstract: Disclosed here is a computer-based device and related methodology that manages use of a dual-mode insulin infusion device. The infusion device operates in a manual insulin delivery mode or an automated closed-loop insulin delivery mode. The methodology receives closed-loop pump data for a user of the infusion device, the closed-loop pump data including data indicating basal insulin delivered by the infusion device during operation in the automated closed-loop insulin delivery mode for at least one defined period of time. The methodology analyzes the closed-loop pump data to generate updated basal rate data for the user, and generates, from the updated basal rate data, a recommendation to adjust a manual-mode basal rate setting of the infusion device. In certain scenarios, the infusion device is controlled such that the manual-mode basal rate setting is adjusted in accordance with the recommendation.

Abstract: A delivery device includes a durable housing portion and a separable disposable portion that selectively engage and disengage from each other. The disposable housing portion secures to the patient and may be disposed of after it has been in use for a prescribed period. Components that normally come into contact with a patient or with infusion media are supported by the disposable housing portion for disposal after the prescribed use, while the durable housing portion supports other components such as electronics for controlling delivery of infusion media from the reservoir and a drive device and drive linkage.

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 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 catheter including a tubular catheter body defining a distal portion, a distal end and a lumen that extends to the distal end, a radiopaque marker carried within the lumen, and a non-metal tip that is bonded to distal end of the catheter body.

Abstract: An electronic medical device is disclosed here. An exemplary embodiment of the medical device includes a printed circuit board assembly, a protective inner shell surrounding at least a portion of the printed circuit board assembly, and an outer shell surrounding at least a portion of the protective inner shell. The printed circuit board assembly has a printed circuit board, electronic components mounted to the printed circuit board, a battery mounted to the printed circuit board, and an interface compatible with a physiological characteristic sensor component. The protective inner shell is formed by overmolding the printed circuit board assembly with a first material having low pressure and low temperature molding properties. The outer shell is formed by overmolding the protective inner shell with a second material that is different than the first material.

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: An insulin infusion device and related operating methods are disclosed. An operating method maintains a configurable, patient-specific, target glucose setpoint for a user of the insulin infusion device, collects historical data associated with operation of the insulin infusion device, and calculates, from the historical data, a target glucose setpoint profile for the user of the insulin infusion device. A current target glucose setpoint value is automatically adjusted over time during a closed-loop operating mode of the insulin infusion device, in accordance with the calculated target glucose setpoint profile. In certain embodiments, the historical data is analyzed to determine a clinically preferred target glucose setpoint value for the user, which is stored for use during the closed-loop operating mode.

Abstract: A method for providing blood glucose data is provided. In response to a suspension of a continuous basal insulin delivery, by an insulin delivery pump, the method identifies a condition indicating continuing hypoglycemia that continues when basal insulin delivery is suspended; and performs an action, by the insulin delivery pump, based on identifying the condition.

Abstract: A fluid delivery system and a fluid conduit assembly suitable for use with the system are disclosed herein. The system includes a fluid infusion pump and a fluid conduit assembly coupled to the pump to deliver medication fluid to a user. The fluid conduit assembly includes a structure defining a flow path for the medication fluid, and a gas trapping filter coupled to the structure and positioned in the flow path. The gas trapping filter functions to filter particulates from the medication fluid and retain gas bubbles from the medication fluid.

Abstract: A method and apparatus for a connection interface between a reservoir or syringe, infusion set tubing, and an infusion pump is provided. The reservoir, a base and a cap are connected to form an integrated unit that is capable of being inserted and secured in an infusion pump housing. The cap and the infusion pump are each provided with at least one sensor or at least one detectable feature, arranged to interact with at least one corresponding detectable feature or sensor on the other of the cap and infusion pump device, to detect one or more of the presence, position or other characteristic of the cap when the cap is aligned or coupled with the infusion pump housing. The detectable feature and sensor may be magnetic, RF, mechanical, optical or any combination.

Abstract: Medical devices and related systems and operating methods for communicating data therewith are provided. An exemplary method involves the medical device detecting an interfacing device coupled to the medical device via a physical communications medium, initializing a wireless communications session with the interfacing device in response to detecting the interfacing device, modulating an electrical signal between the interfacing device and the medical device to transmit data from the medical device to the interfacing device via the physical communications medium, and receiving communications, such as acknowledgments of the transmitted data, from the interfacing device via the wireless communications session.

Abstract: An insulin infusion device and a related operating method are disclosed. The method obtains a blood glucose (BG) measurement of a blood sample from a user, displays the BG measurement on a display element of the infusion device, and receives a confirmation input that indicates user acceptance of the displayed BG measurement. In response to the confirmation input, a glucose sensor calibration routine is automatically initiated, and an insulin bolus calculation is automatically initiated. The calibration routine and the bolus calculation use the confirmed BG measurement. The method continues by controlling delivery of insulin, in accordance with the calculated insulin bolus, from a fluid reservoir of the insulin infusion device. The sensor calibration routine and the insulin bolus calculation are both performed without any additional user involvement or interaction with the user interface other than the user acceptance of the displayed BG measurement.

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 database system includes a database to maintain data pertaining to a plurality of entities and a computing device coupled to the database to identify relationships between different entities of the plurality of entities, generate metadata defining a graph structure maintaining the relationships between the different entities of the plurality of entities for a plurality of different logical layers, and store the metadata in the database.

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: Embodiments of the invention provide implantable glucose sensors enveloped by a biocompatible sleeve as well as methods for making and using them. In such sensors, the biocompatible sleeve is formed from selected materials that function to inhibit or avoid a foreign body response in patients that can be generated by implanted medical devices. Typical embodiments of the invention include an implantable glucose sensor used in the management of diabetes.