Abstract: A set connector system for venting a gas from a fluid reservoir of a fluid infusion device is provided. The set connector system includes a connector system having a first body section coupled to a second body section. The first body section defines a bore in communication with a chamber and a counterbore of the second body section to define a fluid flow path from the fluid reservoir. The chamber of the second body section is in fluid communication with a vent subsystem defined through the second body section. The vent subsystem terminates in an outlet, and the vent subsystem directs gas in the fluid flow path through the second body section to the outlet.

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: A method for monitoring an analyte within the body of a patient, an analyst sensor, and an analyte monitoring apparatus are presented here. In accordance with certain embodiments, the method for monitoring an analyte within the body of a patient includes implanting an analyte sensor at a sensor placement site in the patient. The analyte sensor includes a reference electrode, a counter electrode, a primary working electrode having a first structure, and an auxiliary working electrode having a second structure different from the first structure. The method includes communicating a primary signal from the primary working electrode and an auxiliary signal from the auxiliary working electrode to a processor. Further, the method includes monitoring the primary signal and the auxiliary signal with the processor to characterize a change in a physiological characteristic at the sensor placement site.

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: 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: Subject matter disclosed herein relates to monitoring and/or controlling blood glucose levels in patients. In particular, one or more substances may be delivered to a patient at a particular infusion rate while the patient's estimated glucose level is within a predetermined range. A different insulin infusion rate may then be applied if the patient's estimated blood glucose level deviates outside of the predetermined range.

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 a control system associated with the infusion device obtaining a first measurement indicative of a physiological condition of the user from a first sensing arrangement, obtaining one or more measurements from a second sensing arrangement indicative of a second condition of the user. The control system classifies the second condition as corresponding to one of a plurality of intensity levels based at least in part on the one or more measurements, and thereafter operates the infusion device to deliver the fluid to the user based on the first measurement of the physiological condition in a manner that is influenced by the intensity level classification.

Abstract: Infusion systems including infusion devices and consumables and related operating methods are provided. An exemplary consumable component includes a housing, a reservoir contained within the housing, a pumping mechanism for dispensing a fluid from the reservoir, and a readable element associated with the housing. The readable element maintains calibration data characterizing a relationship between delivery of the fluid and actuation of the pumping mechanism.

Abstract: A system and method for providing closed loop infusion formulation delivery which accurately calculates a delivery amount based on a sensed biological state by adjusting an algorithm's programmable control parameters. The algorithm calculates a delivery amount having proportional, derivative, and basal rate components. The control parameters may be adjusted in real time to compensate for changes in a sensed biological state that may result from daily events. Safety limits on the delivery amount may be included in the algorithm. The algorithm may be executed by a computing element within a process controller for controlling closed loop infusion formulation delivery. The biological state is sensed by a sensing device which provides a signal to the controller. The controller calculates an infusion formulation delivery amount based on the signal and sends commands to an infusion formulation delivery device which delivers an amount of infusion formulation determined by the commands.

Abstract: Medical devices and related patient management systems and parameter modeling methods are provided. An exemplary method involves obtaining, by a computing device, historical measurements of a condition in a body of the patient previously provided by a sensing device, obtaining, by the computing device, historical operational context information associated with preceding operation of one or more of an infusion device and the sensing device, obtaining, by the computing device, historical values for a parameter from one or more of the infusion device and the sensing device, determining, by the computing device a patient-specific model of the parameter based on relationships between the historical measurements, the historical operational context information and the historical values, and providing, by the computing device via a network, the patient-specific model to one of the infusion device, the sensing device or a client device.

Abstract: The invention is directed to a competitive glucose binding affinity assay comprising a glucose receptor (typically mannan binding lectin) labeled with an assay fluorophore and a modified glucose analog (typically dextran) labeled with a reference fluorophore. In certain embodiments, the glucose analog is dextran and is coupled to both a reference fluorophore and a quencher dye (e.g. hexamethoxy crystalviolet-1). Optionally the reference fluorophore is blue shifted relative to the assay fluorophore.

Abstract: A fluid reservoir for a fluid infusion device is provided. The fluid reservoir includes a first portion that has a first end and a second end. The first end includes a fluid delivery port and at least one bubble retaining feature adjacent to the fluid delivery port. The fluid reservoir includes a second portion received in the second end of the first portion and movable within the first portion from the first end to the second end. The fluid reservoir defines a fluid chamber between the first portion and the second portion.

Abstract: A medical therapy system for delivering at least two therapies based on a geographic location of the medical therapy system is disclosed. The medical therapy system includes an infusion pump having a case that contains a processor, memory, a drive mechanism, a reservoir, a radio, and a sensor suite. The sensor suite includes a global positioning system (GPS) receiver to determine a location of the infusion pump. The processor receives the location of the infusion pump and executes first instructions stored in the memory. The processor executes second instructions stored in the memory only when the location of the infusion pump is within a safe zone defined around specified GPS coordinates.

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: An automated reservoir filling system for a portable medical device is disclosed. The system includes a vial sealed by a septum partially filled with a liquid and a gas occupying a headspace. The system further includes a reservoir with a volume defined between a reservoir septum and a plunger head. The plunger head is coupled to a plunger arm which is further coupled to a drive system. Further included is a transfer system with a vial end that pierces the vial septum and remains in contact with the liquid, and a reservoir end that pierces the reservoir septum and remains in the reservoir volume. A controller coupled to the drive system to actuates the drive system automatically drawing fluid from the vial to the reservoir through the degas system.

Abstract: An insertion device for use with an insertion set is provided. The insertion device includes a first housing having a rail. The insertion device includes a hub having a first end coupled to the rail and a second end including a projection. The hub is movable relative to the first housing along the rail. The insertion device includes a locking carrier in the first housing and movable between a first position and a second position. The locking carrier is coupled to the projection in the first position and the projection is released in the second position. The insertion device includes a second housing coupled to the insertion set and surrounding at least a portion of the first housing to define a gap. The locking carrier is received in the gap in the second position to release the projection of the hub and to enable the insertion set to be uncoupled.

Abstract: Microneedle arrays, methods for fabricating microneedle arrays, medical devices, and methods for operating medical devices are provided. A method for fabricating a microneedle array includes providing a sheet blank of material. Further, the method includes stamping the sheet blank of material with a progression of dies, wherein the material is displaced into the microneedle array. A medical device includes a microneedle array, a base member having a first surface supporting the microneedle array and a second surface, and a flexible wall enclosing a chamber between the flexible wall and the second surface of the base member. The flexible wall is biased toward an extended configuration enclosing a first volume in the chamber. Further, the flexible wall is movable to a depressed configuration enclosing a second volume in the chamber less than the first volume.

Abstract: Microneedle arrays, methods for fabricating microneedle arrays, medical devices, and methods for operating medical devices are provided. A method for fabricating a microneedle array includes providing a sheet blank of material. Further, the method includes stamping the sheet blank of material with a progression of dies, wherein the material is displaced into the microneedle array. A medical device includes a microneedle array, a base member having a first surface supporting the microneedle array and a second surface, and a flexible wall enclosing a chamber between the flexible wall and the second surface of the base member. The flexible wall is biased toward an extended configuration enclosing a first volume in the chamber. Further, the flexible wall is movable to a depressed configuration enclosing a second volume in the chamber less than the first volume.

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 obtaining a sequence of measurements indicative of a condition of the user that is influenced by the fluid and modifying one or more unusable measurements in the sequence using one or more other usable measurements in the sequence to obtain a modified sequence of measurements. The method continues by determining a predicted value for the condition of the user at a time in the future based at least in part on the modified sequence of measurements and operating the infusion device in a manner that is influenced by the predicted value.

Abstract: Methods and devices are provided for reducing a diabetic patient's foreign body immune response, including infusion site-loss and/or occlusion. Such foreign body responses are associated with the treatment of the diabetic patient where the treatment requires subcutaneous implantation of a foreign body, such as a cannula or catheter. In certain embodiments of the invention, a response-inhibiting agent is administered to a patient at the site of cannula/catheter insertion, thereby facilitating delivery of insulin to the diabetic patient and mitigating site-loss and/or occlusion over a period of time.