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 powering subassembly for a portable electronic device includes a main battery, a converter, a backup battery, and a controller. The main battery provides a main voltage and the backup battery can provide a backup voltage. The converter receives the main voltage and increases the main voltage to at least one operating voltage. The controller receives the operating voltage from the converter, monitors the voltage of the main battery, and compares the monitored main battery voltage to a main battery low voltage threshold. The controller transmits a disconnect signal to decouple the main battery from the converter if the monitored voltage from the main battery is less than the main battery low voltage threshold. The controller transmits a connection signal to couple the backup battery to the converter if the monitored voltage is less than the main battery low voltage threshold. The backup battery provides the power for a predetermined minimum amount of time.

Abstract: A system and method for calibrating a sensor of a characteristic monitoring system in real time utilizes a self-calibration module for periodic determination of, and compensation for, the IR drop across unwanted resistances in a cell. A current-interrupt switch is used to open the self-calibration module circuit and either measure the IR drop using a high-frequency (MHz) ADC module, or estimate it through linear regression of acquired samples of the voltage across the sensor's working and reference electrodes (Vmeasured) over time. The IR drop is then subtracted from the closed-circuit value of Vmeasured to calculate the overpotential that exists in the cell (Vimportant). Vimportant may be further optimized by subtracting the value of the open-circuit voltage (Voc) across the sensor's working and reference electrodes. The values of Vmeasured and Vimportant are then controlled by respective first and second control units to compensate for the IR drop.

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: Apparatuses and methods for medical monitoring physiological characteristics values such as blood glucose levels for the treatment of diabetes, are presented. The apparatuses and methods provide dynamic glucose monitoring functions that perform predictive analysis to anticipate harmful conditions, such as glucose crash and hyperglycemic incidents for a patient. The dynamic functions can also be used to maximize athletic performance and warn of inadequate nocturnal basal rate. Other aspects include advanced alarm and reminder functions, as well as advanced data presentation tools to further facilitate convenient and efficient management of various physiological conditions.

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: A system is provided for sensing blood glucose data of a patient. The system includes a sensor, user interface, and an optional auxiliary device. If the connection between the sensor and user interface is by a wire, the sensor remains powered when the wire is disconnected. The communication between the sensor and the user interface may be wireless. The auxiliary device can be a patient monitor or other display or signal device, which displays information about the blood glucose data collected by the sensor. The sensor is connected to sensor electronics, which include a sensor power supply, a voltage regulator, and optionally a memory and processor.

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 is provided for sensing blood glucose data of a patient. The system includes a sensor, user interface, and an optional auxiliary device. If the connection between the sensor and user interface is by a wire, the sensor remains powered when the wire is disconnected. The communication between the sensor and the user interface may be wireless. The auxiliary device can be a patient monitor or other display or signal device, which displays information about the blood glucose data collected by the sensor. The sensor is connected to sensor electronics, which include a sensor power supply, a voltage regulator, and optionally a memory and processor.

Abstract: A drive mechanism for delivery of infusion medium a coil capable of being electrically activated to provide an electromagnetic field. The coil surrounds a piston channel extending in an axial direction. An armature is located adjacent the coil, on one side of the axial channel. The armature is moveable toward a forward position, in response to the electromagnetic field produced by activation of the coil. A piston is located within the piston channel and is moveable axially within the channel to a forward position, in response to movement of the armature to its forward position. The armature and piston are moved toward a retracted position, when the coil is not energized. The armature may be configured with a reduced diameter by including a coil cup for supporting the coil including a shelf portion defining at least a portion of a pole surface of the coil cup.

Abstract: A selectively protected electrical system includes or operates with a power source, a load, a power driver circuit for controllably transferring power from the power source to the load, the power driver circuit being encapsulated in a potting material, and a controller for enabling and disabling the power driver circuit, the controller being un-encapsulated by the potting material. If a contaminant induced electrical fault occurs in the selectively protected electrical system, the electrical fault is more likely to occur in the un-encapsulated controller, such that the selectively protected electrical system is disabled. The contaminant is inhibited from contacting and inducing an electrical fault in the power driver circuit, thus providing for a controlled failure of the selectively protected electrical system.

Abstract: Embodiments of the invention provide electrochemical analyte sensors having elements designed to modulate their electrochemical reactions as well as methods for making and using such sensors.

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 method of diabetes analysis is provided. A plurality of glucose level readings for a user is received. The plurality of blood glucose level readings are analyzed to generate a report. The report includes a first chart along a 24-hour timeline indicating the plurality of glucose level readings, and a second chart having at least one of infusion device settings and active insulin levels corresponding to the 24-hour timeline of the first chart.

Abstract: A modular external infusion device that controls the rate a fluid is infused into an individual's body, which includes a first module and a second module. More particularly, the first module may be a pumping module that delivers a fluid, such as a medication, to a patient while the second module may be a programming module that allows a user to select pump flow commands. The second module is removably attachable to the first module.

Abstract: The subject matter disclosed herein relates to systems, methods and/or devices for calibrating sensor data to be used in estimating a blood glucose concentration. A relationship between sensor measurements and reference readings may be used to estimate a relationship between sensor measurements and blood glucose concentration. Such sensor measurements may be weighted according to a decreasing function of uncertainty associated with sensor values.

Abstract: The invention disclosed herein provides methods and materials for observing the state of a sensor, for example those used by diabetic patients to monitor blood glucose levels. Typically a voltage such as a voltage pulse is applied to the sensor in order to solicit a current response from which for example, factors such as impedance values can be derived. Such values can then be used as indicators of a sensor's state, for example the state of sensor hydration, sensor noise, sensor offset, sensor drift or the like.

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: Disclosed are a method and/or system for filtering sensor measurements. In one particular implementation, a sensor signal may be processed concurrently in a plurality of signal-filter paths. A particular signal-filter path may be selected to provide an output signal for obtaining a measurement based, at least in part, on a measurement of noise associated with the sensor signal.

Abstract: A delivery device includes first and second housing portions that selectively engage and disengage. A reservoir on one housing portion operatively engages a drive device and/or a needle inserting device on the other housing portion. Upon proper engagement of the housing portions, the reservoir operatively couples to the drive device and/or the needle inserting device. A first magnet on the first housing portion and a second magnet (or a magnetically-attractive material) on the second housing portion are positioned to magnetically interact with each other, upon operative engagement of the housing portions. A third magnet on the second housing portion may be opposed to the first magnet to help align the housing portions for connection. A magnet-responsive device may be on one or both housing portions to detect alignment and/or connection of the housing portions.