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: An infusion set for use with a fluid infusion device is provided. The infusion set can include a mount including a projection having a bore. The projection can be surrounded at least partially by a recess defined through a surface of the mount, and the mount can include at least one rib that spans the recess. The infusion set can include a fluid outlet coupled to at least a portion of the bore of the projection and a coupling device to couple the infusion set to a user. The coupling device can be coupled to the surface and the at least one rib of the mount.

Abstract: A reservoir and a plunger head contained within may be configured to move relative to each other in response to at least one of the reservoir being detached from a base, the base and/or the reservoir being removed from a packaging, and the base and/or the reservoir being moved relative to each other. A first layer may be configured to define a reservoir, the first layer, which may be made of a material compatible with fluidic media in the reservoir, may be adjacent a second layer for inhibiting a diffusion through the second layer. A first layer that may be less than 0.3 mm and made of a cyclic olefin copolymer may be configured to define a reservoir. A reservoir may be defined by a wall made of a cyclic olefin copolymer and the wall may be for substantially preventing light from passing through the reservoir.

Abstract: A delivery device for delivering fluidic media may include a second housing portion configured to be selectively engaged with and disengaged from a first housing portion adapted to be carried by a user, a drive device configured to be operatively engageable with a plunger arm connected to a plunger head arranged for movement in an axial direction of a reservoir supported by one of the first and second housing portion to drive fluidic media from the reservoir, a drive linkage for operatively engaging the drive device with the plunger arm for allowing the drive device to move the plunger arm, the drive device including a first gear engageable with the plunger arm and a second gear configured for lateral movement to allow the second gear to engage the plunger arm.

Abstract: An infusion system, which may be a closed loop infusion system or “semi-closed-loop” system, uses state variable feedback to control the rate that fluid is infused into the body of a user. The closed loop infusion system includes a sensor system, a controller, and a delivery system. The “semi-closed-loop” system further includes prompts that are displayed or sounded or otherwise provide indications to the user prior to fluid delivery. The sensor system includes a sensor for monitoring a condition of the user. The sensor produces a sensor signal, which is representative of the condition of the user. The delivery system infuses a fluid into the user at a rate dictated by the commands from the controller. The system may use three state variables, subcutaneous insulin concentration, plasma insulin concentration, and insulin effect, and corresponding gains, to calculate an additional amount of fluid to be infused as a bolus and to be removed from the basal delivery of the fluid.

Abstract: A thin film sensor, such as a glucose sensor, is provided for transcutaneous placement at a selected site within the body of a patient. The sensor includes several sensor layers that include conductive layers and includes a proximal segment defining conductive contacts adapted for electrical connection to a suitable monitor, and a distal segment with sensor electrodes for transcutaneous placement. The sensor electrode layers are disposed generally above each other, for example with the reference electrode above the working electrode and the working electrode above the counter electrode. The electrode layers are separated by dielectric layer.

Abstract: A thin film sensor, such as a glucose sensor, is provided for transcutaneous placement at a selected site within the body of a patient. The sensor includes several sensor layers that include conductive layers and includes a proximal segment defining conductive contacts adapted for electrical connection to a suitable monitor, and a distal segment with sensor electrodes for transcutaneous placement. The sensor electrode layers are disposed generally above each other, for example with the reference electrode above the working electrode and the working electrode above the counter electrode. The electrode layers are separated by dielectric layer.

Abstract: A system includes a durable portion with a durable housing and a separable disposable portion with a disposable housing that selectively engage with and disengage from each other. The disposable housing secures to a 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 an infusion medium may be part of the disposable portion to allow for disposal after a prescribed use. A reservoir for holding the infusion medium may be part of the disposable portion, and may be supported by the disposable housing. The durable portion may include other components such as electronics for controlling delivery of the infusion medium from the reservoir, and a drive device including a motor and drive linkage.

Abstract: A device for delivering fluid to a user includes a housing, a drive motor assembly in the housing, other internal components in the housing, and a keypad external to the housing. The device includes a number of features and elements that enhance its operation, manufacturability, reliability, and user-friendliness. These features and elements include a shock absorbing element for a battery of the device, a keypad actuator layer that overlies a keypad assembly and forms a water resistant seal with the housing, and an offset element for a piezoelectric speaker that is located inside the housing.

Abstract: A system includes a durable portion with a durable housing and a separable disposable portion with a disposable housing that selectively engage with and disengage from each other. The disposable housing secures to a 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 an infusion medium may be part of the disposable portion to allow for disposal after a prescribed use. A reservoir for holding the infusion medium may be part of the disposable portion, and may be supported by the disposable housing. The durable portion may include other components such as electronics for controlling delivery of the infusion medium from the reservoir, and a drive device including a motor and drive linkage.

Abstract: Embodiments of the invention provide analyte sensors having optimized elements and/or configurations of 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: Novel optical devices, methods and systems relating to the detection of glucose, and more particularly to real-time glucose monitoring, are disclosed herein. More particularly, various hardware and methodological means are disclosed for ratiometric correction of optical glucose measurements for artifacts of optical systems.

Abstract: A substrate with hermetically sealed vias extending from one side of the substrate to another and a method for fabricating same. The vias may be filled with a conductive material such as, for example, a fritless ink. The conductive path formed by the conductive material aids in sealing one side of the substrate from another. One side of the substrate may include a sensing element and another side of the substrate may include sensing electronics.

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: Apparatus are provided for infusion devices and related operating methods. An exemplary infusion device includes a housing to receive a shaft coupled to a plunger disposed in a reservoir and a gear assembly including a first gear to engage the shaft, wherein the first gear exhibits rotational freedom in a direction opposite a delivery direction. One exemplary method of operating the infusion device comprises identifying a reset condition and in response to the reset condition, operating a motor having a rotor coupled to the gear assembly to provide the rotational freedom for the first gear.

Abstract: Embodiments of the invention provide amperometric analyte sensors having optimized elements such as electrodes formed from sputtered platinum compositions as well as layers of material selected to optimize the characteristics of a wide variety of sensor elements and sensors. 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: A fluid infusion system including a pocketable pump housing with a reservoir cavity with helical coupling features. The system further has a reservoir with an open end that is removable from the reservoir cavity. A removable cap coupled to the housing is also included in the system. The cap has corresponding coupling features, an exterior surface and a tab. The corresponding coupling features couple the cap to the housing while the tab is a ridge that extends away from the exterior surface. The tab has a port to accommodate flow from the reservoir and the port defines an axis of rotation such that torque applied to the tab about the axis of rotation disengages the coupling between the cap and the housing. The system further has a removably coupled guard with a slot defined to immobilize rotation of the tab about the axis of rotation.

Abstract: Apparatus are provided for infusion devices and related control systems and methods. An infusion device includes a voided portion adapted to receive a shaft portion that includes a shaft coupled to a plunger of a reservoir and a sensing arrangement proximate the voided portion to sense a detectable feature. A control module may determine a remaining amount of fluid in the reservoir or identify an anomalous condition based at least in part on the sensed position of the detectable feature.

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: A sensing apparatus may include a substrate having a first side for a sensing element and a second side for electronics, the substrate may have a at least one via from the first side of the substrate to the second side of the substrate, the at least one via may be hermetically sealed with an optically transmissive material.