Abstract: Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device involves obtaining one or more measurement values of a physiological condition in the body of a user during an initial monitoring period and determining a fasting reference value for a metric based on the one or more measurement values. After the initial monitoring period, the method continues by obtaining an updated measurement value during a fasting period, determining a current value for the metric based at least in part on the updated measurement value, and generating a notification in response to a deviation between the current value and the fasting reference value exceeding a threshold indicative of insertion site loss or other loss of effectiveness.

Abstract: A belt clip assembly is disclosed. The belt clip assembly includes a device retainer having a first retainer defined to retain a clip pin. The belt clip assembly further includes a clip coupled to the device retainer via the clip pin and the clip includes a detent and the clip is further defined to retain a tab pin. A tab is coupled to the clip via the tab pin, the tab being rotatable about the tab pin. Wherein the device retainer is initially rotatable about the clip pin independent of rotation of the tab about the tab pin. Additionally, the rotation of the device retainer about the clip pin results in a finite displacement of the device retainer.

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 first value for a physiological condition being influenced by the fluid, determining a metric corresponding to a future physiological condition of the user based at least in part on the first value, and automatically generating a first alert based on the metric. After automatically generating the first alert, the method continues by obtaining a second value for the physiological condition of the user and automatically clearing the first alert based at least in part on the second 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: Disclosed are methods, apparatuses, etc. for glucose sensor signal reliability analysis.

Abstract: A medical therapy system to deliver a pre-bolus volume of medicant is disclosed. The medical therapy system includes an infusion pump that has a case containing a processor, memory, a drive mechanism, a reservoir, communication hardware and a sensor system. The infusion pump further includes a global positioning system (GPS) receiver to determine GPS coordinates of the infusion pump. The GPS receiver is coupled to the processor that executes stored program instructions to provide notification for confirmation to deliver a pre-bolus volume from the reservoir when the GPS coordinates of the infusion pump are within a specified proximity of GPS coordinates of a saved location.

Abstract: The invention pertains to analyte sensors designed to include layered compositions that provide these sensors with enhanced functional and/or material properties including, for example, resistance to damage caused by ethylene oxide during sterilization processes. Embodiments of the invention include polyvinyl alcohol N-methyl-4(4?-formylstyryl)pyridinium (SbQ) polymer materials and methods for employing such materials during the ethylene oxide sterilization of glucose sensors.

Abstract: A medical device as described herein includes a communication module to process radio frequency signals associated with operation of the medical device, an antenna associated with the communication module, and a microstrip transmission component coupled between the communication module and the antenna. The transmission component includes a dielectric substrate, an electrically conductive signal trace formed overlying the upper major surface of the substrate, an electrically conductive ground plane formed overlying the lower major surface of the substrate, and a complementary split ring resonator arrangement integrally formed in the ground plane, and having a layout and dimensions tuned to cause the resonator arrangement to resonate at one or more harmonic frequencies of the nominal transmission frequency of the radio frequency signals.

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 amount of active fluid in the body of the user, determining a threshold amount of active fluid in the body of the user, and automatically altering operation of the infusion device to modify delivery of the fluid to the user based on a relationship between the current amount and the threshold amount.

Abstract: Apparatus are provided for infusion devices and related control systems and methods. In one embodiment, an infusion device includes a voided portion adapted to receive a shaft portion that includes a shaft coupled to a plunger of a reservoir. The shaft portion includes a detectable feature, and the infusion device includes a sensing arrangement proximate the voided portion to sense the detectable feature. In some embodiments, a control module is coupled to the sensing arrangement to determine a remaining amount of fluid in the reservoir based at least in part on the sensed position of the detectable feature. In other embodiments, the control module identifies an anomalous condition based at least in part on the sensed position of the detectable feature.

Abstract: Apparatus are provided for motor control systems and related medical devices. In one embodiment, a control system includes a motor having a rotor, a sensor to obtain a measured displacement that is influenced by rotation of the rotor, and a control module coupled to the sensor. The control module adjusts a duty cycle for a modulated voltage applied to the motor in response to a difference between an expected displacement and the measured displacement. The expected displacement is influenced by or otherwise corresponds to a commanded rotation of the rotor.

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: Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device to deliver fluid to a body of a user involves identifying a current site location on the body of the user associated with a sensing arrangement providing sensed measurements of a physiological condition in the body of the user at the current site location, determining one or more performance metrics associated with the current site location corresponding to operation of the infusion device to deliver the fluid in response to the sensed measurements, and providing sensor site feedback in a manner that is influenced by the one or more performance metrics. In one or more embodiments, the sensor site feedback includes recommended sensor site locations for rotation or replacement of the sensing arrangement determined based on historical data associated with the user for different sensor site locations.

Abstract: The present invention describes improved systems and methods for attaching external medical devices to the body of a patient using a multilayer attachment apparatus. Medical devices that require attachment to the body, including monitoring devices, drug-infusing devices and the like, can utilize embodiments of the attachment apparatus and method described herein. Embodiments of the invention include new adhesive and hook and loop attachment mechanisms and methods for using embodiments of the multilayer attachment apparatus to attach medical device and/or medical device components to the body.

Abstract: Systems and methods for a fluid reservoir for use with a fluid infusion device, which is automatically filled are provided. The fluid reservoir includes a barrel having a proximal end and a distal end. The fluid reservoir also includes a stopper received in the barrel and movable within the barrel from the distal end to the proximal end to dispense a fluid from a passageway of the barrel. The fluid reservoir includes at least one engagement feature defined along a portion of a perimeter of the barrel near the proximal end that removably couples the fluid reservoir to the fluid infusion device.

Abstract: A continuous glucose monitoring system may include a hand-held monitor, a transmitter, an insulin pump, and an orthogonally redundant glucose sensor, which may comprise an optical glucose sensor and a non-optical glucose sensor. The former may be a fiber optical sensor, including a competitive glucose binding affinity assay with a glucose analog and a fluorophore-labeled glucose receptor, which is interrogated by an optical interrogating system, e.g., a stacked planar integrated optical system. The non-optical sensor may be an electrochemical sensor having a plurality of electrodes distributed along the length thereof. Proximal portions of the optical and electrochemical sensors may be housed inside the transmitter and operationally coupled with instrumentation for, e.g., receiving signals from the sensors, converting to respective glucose values, and communicating the glucose values.

Abstract: Embodiments of the invention provide analyte sensors having optimized electrodes and/or 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: A fluid infusion device is provided. The device comprises a drive system that includes a movable slide. The slide includes a first coupling device. The device also comprises a fluid reservoir that includes a stopper movable relative to the fluid reservoir by the slide to advance a fluid out of the fluid reservoir. The stopper includes a second coupling device that cooperates with the first coupling device to resist the movement of the stopper relative to the slide.

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: 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.