Abstract: A method of making a system for transferring fluidic media may include placing a reservoir body in an aseptic environment; filling an interior volume of the reservoir body with fluidic media; placing a plunger head into the reservoir body, the plunger head adapted to be movable in an axial direction within the reservoir body; removing the reservoir body from the aseptic environment; and attaching a casing adjacent to at least a portion of the reservoir body with the reservoir body outside the aseptic environment, the casing configured to envelope at least a portion of a plunger arm operatively connected to the plunger head, the casing further configured to allow the plunger arm to move in the axial direction relative to the reservoir body and at least partially within the reservoir body.

Abstract: A portable medical device is provided with an internal accelerometer device. The medical device includes a circuit board, the accelerometer device, and a response module coupled to the accelerometer device. The accelerometer device is mechanically and electrically coupled to the circuit board, and it includes a plurality of mass-supporting arms for a plurality of electrically distinct sensor electrodes, piezoelectric material for the mass-supporting arm, and a proof mass supported by the mass-supporting arms. Each of the mass-supporting arms has one of the sensor electrodes located thereon. Acceleration of the proof mass causes deflection of the piezoelectric material, which generates respective sensor signals at one or more of the sensor electrodes. The response module is configured to initiate an acceleration-dependent operation of the portable medical device in response to generated sensor signals present at the sensor electrodes.

Abstract: A medical device system may include a set of housing portions, which includes a first housing portion and a second housing portion, and a third housing portion configured to be selectively operatively engaged with and disengaged from each of the first housing portion and the second housing portion. Each of one or more fluid conduits may provide a fluid path between a user and one or more reservoirs, for containing fluidic media, supported by at least one of the third housing portion and a selected one of the first housing portion and the second housing portion. A drive device supported by the third housing portion may be configured to transfer fluidic media between one of the one or more reservoirs and the user via the fluid conduit in a case where the third housing portion is operatively engaged with one of the first housing portion and the second housing portion.

Abstract: Embodiments of the invention provide to apparatuses and media used in drug elution studies and methods for making and using them. One embodiment of the invention is a drug elution method that can be used for in-vitro studies of a matrix impregnated with a compound such as a drug blended polymer matrix. Such methods and materials can be used for example to assess and control the manufacturing process variability of drug eluting implantable devices such as cardiac leads.

Abstract: Various embodiments of the present invention are directed to equalizing pressure in a reservoir containing fluidic media, possibly due to imperfect installation of the reservoir or an external influence such as an altitude or a temperature change. In various embodiments, fluidic media may be expelled from the reservoir through a needle and contained in an interior volume of a pierceable member before the needle pierces the pierceable member to establish a flow path to a user. In other embodiments, fluidic media may be expelled through a port of the reservoir into a chamber. In further embodiments, fluidic media may be expelled through a channel in a plunger head and out a passage in the reservoir when the channel and passage are aligned. In other embodiments, fluidic media may be expelled through a valve, and the valve may be pierceable by a needle to establish a flow path to the user.

Abstract: A transfer guard may provide a fluid path from a vial to a reservoir containing a plunger head connected to a plunger arm operatively engagable with a handle that at least partially covers a casing configured to allow the handle to operatively engage the plunger arm to move the plunger head to transfer fluidic media from the vial to the reservoir. A support structure may have a chamber, a first adapter for mating with a vial containing fluidic media, and a second adapter for mating with a reservoir containing a plunger head moveable within the reservoir. A first needle may provide a fluid path from the vial to the reservoir and a second needle may connect the vial and the chamber containing an air flow control mechanism for allowing air to flow in one direction.

Abstract: A transfer guard may provide a fluid path from a vial to a reservoir containing a plunger head connected to a plunger arm operatively engagable with a handle that at least partially covers a casing configured to allow the handle to operatively engage the plunger arm to move the plunger head to transfer fluidic media from the vial to the reservoir. A support structure may have a chamber, a first adapter for mating with a vial containing fluidic media, and a second adapter for mating with a reservoir containing a plunger head moveable within the reservoir. A first needle may provide a fluid path from the vial to the reservoir and a second needle may connect the vial and the chamber containing an air flow control mechanism for allowing air to flow in one direction.

Abstract: An infusion system, which may be a closed loop, or “semi-closed-loop”, infusion system, uses state variable feedback to control the rate at which fluid is infused into a user's body. The closed loop system includes a sensor system, a controller, and a delivery system. The “semi-closed-loop” system further includes prompts that provide indications to the user prior to fluid delivery. The sensor system includes a sensor for monitoring a condition of the user and produces a sensor signal which is representative of the user's condition. 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, e.g., subcutaneous insulin concentration, plasma insulin concentration, and insulin effect, and corresponding gains, to calculate an additional amount of fluid to be infused with a bolus and to be removed from the basal delivery of the fluid.

Abstract: A fluid infusion system as described herein includes a number of local “body network” devices, such as an infusion pump, a handheld monitor or controller, a physiological sensor, and a bedside or hospital monitor. The body network devices can be configured to support communication of status data, physiological information, alerts, control signals, and other information between one another. In addition, the body network devices can be configured to support networked communication of status data, physiological information, alerts, control signals, and other information between the body network devices and “external” devices, systems, or communication networks. Such external communication allows the infusion system to be extended beyond the traditional short-range user environment.

Abstract: The invention provides methods and apparatus for detecting an analyte in blood. The apparatus is particularly suited for bringing a sensor into direct contact with blood in vivo. The apparatus comprises a sensor that detects the presence of an analyte and an assembly means. The assembly means has a sensor end, wherein the sensor end of the assembly means is affixed to the sensor, and the assembly means is adapted for coupling with a venous flow device. By coupling with a venous flow device, the assembly means brings the sensor into direct contact with blood flowing through the venous flow device. Examples of venous flow devices that bring the sensor into direct contact with the blood of a subject include, but are not limited to, intravenous catheters and external blood loops, such as are used in extra corporeal membrane oxygenation or hemodialysis.

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 medical device system includes at least one controllable patient-worn or patient-carried medical device, and a plurality of controller devices that are capable of independently controlling features or functions of the patient medical device. Control commands and other data is wirelessly communicated among the patient medical device and the multiple controller devices. A number of techniques, protocols, and other measures are provided to coordinate wireless communication between the various devices in a medical device system. These control command coordination processes address situations where conflicting, redundant, or concurrent control commands might be independently issued by the multiple controller devices.

Abstract: Various embodiments of the present invention are directed to patches for medical devices. In various embodiments, an adhesive patch of a medical device may have selective areas with adhesive material of varying adhesion strengths. In other embodiments, an adhesive patch of a medical device may include adhesive material that may be activated by a catalyst to increase or decrease the adhesion strength of the adhesive material. In further embodiments, a medical device may include a pierceable membrane containing an agent, the pierceable membrane positioned to be pierced by a needle and to cause some of the agent to be carried to the user-patient.

Abstract: A reagent for use in detecting an analyte comprises a fluorescent energy donor and an energy acceptor, wherein the energy acceptor is of the general formula: and wherein the distance between the energy donor and the energy acceptor of the reagent is capable of modulation by a suitable analyte to be detected.

Abstract: An infusion set for subcutaneous delivery of an infusant. The infusion set may include a base removably attachable to an infusion site and a connector temporarily lockable to the base. The connector can engage the base in a plurality of orientations. The connector locks into the base after at least partial rotation of the connector about the base. The connector may include flexible arms which unlock the connector from the base. The base includes a cannula for insertion through the infusion site. The connector includes a tubing for passing the infusant. The infusant is subcutaneously passable from the tubing through the cannula when the connector is attached to the base. The infusion set may also include a hub removably attachable to the base that includes a needle that extends through the base and the cannula and a guard removably attachable to the base opposite the hub for surrounding the needle.

Abstract: Various embodiments of the present invention are directed to equalizing pressure in a reservoir containing fluidic media, possibly due to imperfect installation of the reservoir or an external influence such as an altitude or a temperature change. In various embodiments, fluidic media may be expelled from the reservoir through a needle and contained in an interior volume of a pierceable member before the needle pierces the pierceable member to establish a flow path to a user. In other embodiments, fluidic media may be expelled through a port of the reservoir into a chamber. In further embodiments, fluidic media may be expelled through a channel in a plunger head and out a passage in the reservoir when the channel and passage are aligned. In other embodiments, fluidic media may be expelled through a valve, and the valve may be pierceable by a needle to establish a flow path to the user.

Abstract: Systems and processes for managing data relating to one or more medical or biological conditions of a plurality of subjects (such as patients) over a wide area network, such as the Internet, may be employed for diabetes subjects or subjects with other medical conditions requiring monitoring and/or treatment over time. Such systems and processes provide various functions for several types of users, including patients or subject-users, healthcare provider-users and payor entity-users and combinations thereof, which allow for improved treatment and medical data management of individual subjects and groups of subjects and which allow collection and analysis of aggregate data from many subject sources, for improving overall healthcare practices of providers and subjects (e.g., patients).

Abstract: An infusion system to administer a fluid includes an infusion pump with a pump processor, a pump memory to store a plurality of configurable alarms and a pump radio to enable bi-directional communication. The infusion system further includes a controller that has a controller processor, a controller memory, a controller radio to transmit and receive communication from the pump radio. The controller further has a graphical user interface shown on a display along with controls to manipulate the graphical user interface. Furthermore, the bi-directional communication between the infusion pump and the controller establish an infusion pump relative proximity between the infusion pump and the controller such that when the infusion pump relative proximity exceeds a pump threshold distance at least one of the plurality of configurable alarm conditions of the infusion pump is modified.

Abstract: A delivery system for delivering fluidic media may include a second housing configured to be selectively operatively engaged with and disengaged from a first housing portion adapted to be carried by a user. One of the housing portions may support a reservoir for containing fluidic media and a plunger head moveable within the reservoir. A drive device may be supported by the other of the housing portions for coupling with the reservoir upon the housing portions being operatively engaged. A first interactive element may be supported on the first housing portion for interacting with a second interactive element supported on the second housing portion. Circuitry may be configured to detect an interaction between the interactive elements and configured to provide a signal or a change in state in response to the housing portions being operatively engaged and an interaction between the interactive elements being detected.

Abstract: A method of calibrating glucose monitor data includes collecting the glucose monitor data over a period of time at predetermined intervals, obtaining reference glucose values from a reference source that temporally correspond with the glucose monitor data obtained at the predetermined intervals, calculating the calibration characteristics using the reference glucose values and corresponding glucose monitor data to regress the obtained glucose monitor data, and calibrating the obtained glucose monitor data using the calibration characteristics. In additional embodiments, calculation of the calibration characteristics includes linear regression and, in particular embodiments, least squares linear regression. Alternatively, calculation of the calibration characteristics includes non-linear regression. Data integrity may be verified and the data may be filtered.