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.

Abstract: A method and apparatus for a connection interface between a reservoir or syringe, infusion set tubing, and an infusion pump is provided. A base is provided which is adapted to receive a reservoir. The base has a base engagement member, such as a detent, projecting therefrom. A cap is provided which is adapted to receive the base. The cap includes a first cap engagement member, such as a detent opening, which is adapted to removably engage the base detent. The cap further includes a second cap detent opening which is adapted to removably engage the base detent. A piercing member, such as a needle, is disposed in the interior of the cap in such a manner that the needle is separated from the reservoir septum when the base detent is in the first cap detent opening, and the needle pierces the reservoir septum when the base detent is in the second cap detent opening.

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: An insertion device and insertion set. The insertion device for inserting at least a portion of at least one piercing member of an insertion set through the skin of a patient includes a device housing, a carrier body and a driver. The carrier body is slidably received within the device housing for movement between an advanced position and a retracted position. The carrier body also includes a receiving structure to support the insertion set in a position with the at least one piercing member oriented for insertion through the skin of the patient at a predetermined or variable angle relative to the skin of the patient upon movement of the carrier body from the retracted position to the advanced position.

Abstract: Systems and methods for non-vascular sensor implantation and for measuring physiological parameters in areas of a body where the physiological parameters are heterogeneous. An implant unit is implanted in an area of a body and a foreign body capsule is allowed to form around the implant unit area. A sensor may be directed into a body cavity such as, for example, the peritoneal space, subcutaneous tissues, the foreign body capsule, or other area. A subcutaneous area of the body may be tunneled for sensor placement. Spatially separated sensing elements may be used for detecting individual amounts of the physiological parameter. An overall amount of the physiological parameter may be determined by calculating a statistical measurement of the individual sensed amounts in the area. Another embodiment of the invention, a multi-analyte measuring device, may include a substrate having an electrode array on one side and an integrated circuit on another side.

Abstract: An infusion system is for infusing a fluid into the body of a patient. The infusion system includes at least one sensor for monitoring blood glucose concentration of the patient and an infusion device for delivering fluid to the patient. The sensor produces at least one sensor signal input. The infusion device uses the at least one sensor signal input and a derivative predicted algorithm to determine future blood glucose levels. The infusion device delivers fluid to the patient when future blood glucose levels are in a patient's target range. The infusion device is capable of suspending and resuming fluid delivery based on future blood glucose levels and a patient's low shutoff threshold. The infusion device suspends fluid delivery when future blood glucose levels falls below the low shutoff threshold. The infusion device resumes fluid delivery when a future blood glucose level is above the low shutoff threshold.

Abstract: A method of seating a fluid reservoir in a housing of a fluid infusion device is presented here. The method is performed prior to establishing an outgoing fluid flow path from the fluid reservoir. The method begins by detecting insertion of the fluid reservoir into the housing of the fluid infusion device. In response to detecting the insertion, the method determines whether the fluid reservoir is in need of depressurization. When the fluid reservoir is in need of depressurization, the drive motor assembly of the fluid infusion device is rewound to depressurize the fluid reservoir. After depressurizing the fluid reservoir, an equalization state for the fluid reservoir is achieved. After achieving the equilibrium state, the drive motor assembly is advanced to obtain an initial seated state for the fluid reservoir.

Abstract: An apparatus for delivering a fluid includes a housing, an inlet in the housing for receiving the fluid, and an outlet in the housing for discharging the fluid. A piston channel is provided within the housing through which the fluid flows from the inlet to the outlet. An actuator is positioned within the housing and is moveable between a retracted position and a forward position, the actuator defining a piston chamber for storing fluid received through the inlet when the actuator is in the retracted position and for driving the fluid stored in the piston chamber toward the outlet when the actuator transitions from the retracted position to the forward position. The actuator includes an armature and a piston coupled to the armature and moveable within the piston channel. The piston is provided with a groove in an outer surface for conducting fluid from the inlet to the outlet.

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-user and may be disposed of after it has been in use for a prescribed period. Components that normally come into contact with a patient-user or with infusion medium are supported by the disposable housing portion, while the durable housing portion supports other components such as electronics and a drive device. A reservoir is supported by the disposable housing portion and has a moveable plunger that operatively couples to the drive device, when the disposable and durable housing portions are engaged.

Abstract: Apparatuses and methods for a connection interface between a reservoir or syringe, infusion set tubing, and an infusion pump are provided. A base is provided which is adapted to receive a reservoir and engage a cap. A piercing member, such as a needle, is disposed in the interior of the cap in such a manner that the needle is separated from the reservoir septum when the base is in a first detent position, and the needle pierces a reservoir septum when the base is in a second detent position. When the reservoir, the base and the cap are connected to form an integrated unit, this unit is then capable of being inserted and secured in the infusion pump housing. In some embodiments, an integral connector couples directly to the reservoir.

Abstract: A portable electronic device, such as a fluid infusion device, obtains its operating power from a primary battery and a secondary battery. The primary battery may be a replaceable battery, and the secondary battery may be a rechargeable battery that can be charged with the primary battery under certain conditions. The device utilizes a power management scheme that transitions between the primary battery and/or the secondary battery to prolong the useful life of the primary battery. The device may also generate an intelligent battery life indicator that displays an accurate representation of the remaining life of the primary battery.

Abstract: An infusion set component for a fluid infusion device that delivers fluid to a patient is presented here. The component includes a tube formed from tubing material having an interior fluid canal defined therein to provide a fluid pathway from the fluid infusion device to the patient, a plurality of sensor conductors incorporated with the tubing material to facilitate sensing of an analyte of the patient by the fluid infusion device, and a combined infusion-sensor unit coupled to the tube and to the plurality of sensor conductors. The infusion-sensor unit accommodates delivery of fluid from the tube, and it also accommodates sensing of the analyte. The component may also include a connector assembly coupled to the tube and to the plurality of sensor conductors, to fluidly couple the fluid canal to a fluid reservoir of the fluid infusion device and to electrically couple the sensor conductors to an electronics module of the fluid infusion device.

Abstract: A portable electronic device, such as a fluid infusion device, obtains its operating power from a primary battery and a secondary battery. The primary battery may be a replaceable battery, and the secondary battery may be a rechargeable battery that can be charged with the primary battery under certain conditions. The device utilizes a power management scheme that transitions between the primary battery and/or the secondary battery to prolong the useful life of the primary battery. The device may also generate an intelligent battery life indicator that displays an accurate representation of the remaining life of the primary battery.

Abstract: An improved pump, reservoir and reservoir piston are provided for controlled delivery of fluids. A motor is operably coupled to a drive member, such as a drive screw, which is adapted to advance a plunger slide in response to operation of the motor. The plunger slide is removably coupled to the piston. A method, system, and an article of manufacture for automatically detecting an occlusion in a medication infusion pump is provided. The electrical current to an infusion pump is measured. Based on a series of measurements of one or more variables, the infusion pump detects whether there is an occlusion in the system.

Abstract: An analyte sensor and systems for determining analyte levels in a user's body. The analyte sensor and systems are adapted to be used with single dose medication devices and include a communication system to transmit the communications from the analyte sensor to the user to notify the user of an estimated amount of fluid to deliver to the user's body. More particularly, these apparatuses and methods for use are for providing convenient monitoring of blood glucose levels in determining the appropriate amount of insulin to deliver.

Abstract: A glucose sensor product is manufactured by a process that maintains the sterility of the glucose sensor while allowing gaseous manufacturing by-products to be vented from the inside of the glucose sensor package. The method begins by placing a glucose sensor assembly into a plastic package tray having a sealing surface surrounding an opening. The method continues by covering the opening with a microbial barrier material such that the microbial barrier material overlies the sealing surface, forming a seal between the sealing surface and the microbial barrier material, resulting in a sealed package tray containing the glucose sensor assembly, and sterilizing the glucose sensor assembly inside the sealed package tray. The microbial barrier material maintains sterility of the glucose sensor assembly while allowing volatile by-products outgassed from the glucose sensor assembly and the plastic package tray to pass therethrough.

Abstract: A device for delivering fluid to a user includes a housing, a drive motor assembly in the housing, a force sensor, and an electronics module. The drive motor assembly regulates delivery of fluid by actuating a piston of a fluid reservoir, and the force sensor generates output levels in response to force imparted thereto during, for example, fluid delivery operations. The electronics module processes the output levels of the force sensor to assess the operating health of the force sensor, to check for occlusions in the fluid delivery path, and to monitor the seating status of the fluid reservoir.

Abstract: A method and apparatus for a connection interface between a reservoir or syringe, infusion set tubing, and an infusion pump is provided. The elements of the apparatus are organized so that it is capable of being inserted and secured in an infusion pump housing.

Abstract: An infusion system includes a characteristic determining device and an infusion device. The characteristic determining device includes a receptacle for receiving and testing an analyte from the user to determine a concentration of the analyte in the user. The characteristic determining device also includes a communication system for transmitting a communication including data indicative of the determined concentration of the analyte in the user, and the infusion device includes a communication system for receiving the communication from the characteristic determining device. The infusion device further includes a bolus estimator for calculating an estimated amount of fluid to be infused into the body of the user based upon the received data indicative of the determined concentration of the analyte in the user and a target concentration of the analyte in the user, and an indicator to indicate when the estimated amount of fluid to be infused has been calculated.

Abstract: Systems, apparatus, and methods are provided for initializing a voltage bus. An exemplary system includes an input interface, a voltage bus, discharge circuitry coupled to the voltage bus, connection circuitry coupled between the voltage bus and the input interface, and a control module coupled to the connection circuitry and the discharge circuitry. The control module activates the discharge circuitry prior to activating the connection circuitry.