Abstract: Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device involves obtaining a filtered measurement indicative of a physiological condition of a user, determining a metric indicative of a characteristic of the filtered measurement based at least in part on one or more derivative metrics associated with the filtered measurement, and determining an output measurement indicative of the physiological condition of the user based at least in part on the filtered measurement, the metric, and a previous output measurement.

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 one or more uncalibrated measurements indicative of the physiological condition, obtaining one or more reference measurements of the physiological condition, determining a raw calibration factor based on a relationship between the one or more uncalibrated measurements and the one or more reference measurements corresponding to the respective uncalibrated measurements of the one or more uncalibrated measurements, and determining an adjusted calibration factor based at least in part on an expected calibration factor and the raw calibration factor, wherein operation of the infusion device to deliver the fluid is influenced by the adjusted calibration factor.

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 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 infusion media are supported by the disposable housing portion for disposal after the prescribed use, while the durable housing portion supports other components such as electronics for controlling delivery of infusion media from the reservoir and a drive device and drive linkage.

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 physiological characteristic sensor, a method for forming a physiological characteristic sensor, and a method for forming a platinum deposit having a rough surface are presented here. The method for forming a physiological characteristic sensor includes immersing a sensor electrode in a platinum electrolytic bath. Further, the method includes performing an electrodeposition process by sequentially applying a pulsed signal to the sensor electrode and applying a non-pulsed continuous signal to the sensor electrode to form a platinum deposit on the sensor electrode.

Abstract: A fluid infusion device and related operating methods are presented here. An exemplary embodiment of the device includes a drive motor assembly, a force sensor associated with the drive motor assembly, and a reservoir cavity that accommodates fluid reservoirs. An exemplary operating method for the device obtains force measurements for a reservoir seating action of the drive motor assembly, where the force measurements indicate measures of force imparted to the force sensor during the reservoir seating action. The method continues by determining that a vent in the reservoir cavity is blocked, based on an analysis of the force measurements, and by initiating corrective action for the fluid infusion device in response to determining that the vent in the reservoir cavity is blocked.

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 determining a current amount of active fluid in the body of the user, determining a threshold amount of active fluid in the body of the user, and automatically altering operation of the infusion device to modify delivery of the fluid to the user based on a relationship between the current amount and the threshold amount.

Abstract: A method of measuring blood glucose of a patient is presented here. In accordance with certain embodiments, the method applies a constant voltage potential to a glucose sensor and obtains a constant potential sensor current from the glucose sensor, wherein the constant potential sensor current is generated in response to applying the constant voltage potential to the glucose sensor. The method continues by performing an electrochemical impedance spectroscopy (EIS) procedure for the glucose sensor to obtain EIS output measurements. The method also performs a nonlinear mapping operation on the constant potential sensor current and the EIS output measurements to generate a blood glucose value.

Abstract: Embodiments of the invention provide analyte sensors having optimized permselective membranes and methods for making and using such sensors. Embodiments of the invention also provide analyte sensors such as those having porous matrices coated with an analyte sensing composition and methods for making and using such sensors. Illustrative embodiments include electrochemical glucose sensors having glucose oxidase coatings.

Abstract: An insertion system to precisely locate the insertion site for a sensor is disclosed. The insertion system includes an insertion guide with a protective layer, a guide layer and a liner layer. The protective layer is on top of the guide layer and the guide layer has a first locating structure and adhesive on the bottom. The liner layer is below the guide layer. The insertion system further includes an insertion tool with a corresponding first locating structure that interfaces with the first locating structure, wherein alignment of the first locating structure and corresponding first locating structure establishes placement of the insertion tool and subsequently the sensor.

Abstract: An infusion system having a priming detection system to indicate that a component of the system, for example a cannula or needle, is primed with a fluid to be delivered into an individual's body. The infusion system utilizes a reactive element that reacts with the fluid or at least one component of the fluid to be delivered, to produce a color change or a colored complex. The reactive element can be deposited, coated or otherwise incorporated in any component of the infusion system that would benefit from a visible indication of a primed fluid, including, but not limited to a tubing, infusion set, cannula, needle and/or guard element at least partially covering or surrounding a cannula or needle. The visual indication improves the user experience during the priming and filling of the system by providing a clear color change confirmation upon priming completion and prior to insertion into the body.

Abstract: A medical device having an indicator to indicate whether the medical device has a waterproof seal enclosing an interior volume. The medical device includes a housing having an indicator formed on the exterior surface of the housing. The indicator is capable of moving from a first position to a second position, where the first position indicates that the medical device housing has a waterproof seal to prevent ingress of water into the interior volume of the medical device and the second position indicates that there is a leak in the housing.

Abstract: A monitor system to monitor a characteristic of a user is disclosed. A monitor system includes a sensor producing signals indicative of glucose characteristics within the user. The sensor has a connector with a plurality of contacts, at least two contacts being shorted by a fuse trace. The monitor system further includes an electronics package with a package housing. The package housing contains a battery, a package port interfaced with the connector to receive signals from the sensor, and a package processor to process the signals from the sensor. Further included in the monitor system is a fuse system controlled by the package processor that includes a fuse timer, wherein the fuse trace is destroyed after the fuse timer reaches a threshold value.

Abstract: A medication pump test device and method of use including a test device for use with a medication pump and a depth indicator, the test device including: an external body portion defining a depth indicator recess operable to receive the fixed portion of the depth indicator; an internal body portion attached to the external body portion, the internal body portion defining a slide spindle passage operable to allow free axial movement of the slide spindle of the depth indicator. The test device maintains the fixed portion of the depth indicator at a fixed axial position along the central axis relative to the medication pump when the fixed portion of the depth indicator is seated in the depth indicator recess, the external contact portion contacts the medication pump, and the internal body portion is seated in the open end of the reservoir compartment.

Abstract: An infusion system to administer fluid is disclosed. The infusion system to administer fluid includes an infusion pump having a pump processor, a pump memory and a pump radio to enable bi-directional communication. The pump radio further includes a configurable attenuator and the pump memory stores a plurality of security modes that configure the attenuator to receive signals of a predetermined strength. The infusion system further includes a controller with a controller processor, a controller memory, and a controller radio to transmit and receive communication from the pump radio. The controller further having a graphical user interface shown on a display, and controls to manipulate the graphical user interface. The controller further being paired with the infusion pump based on pairing data, wherein a security check is performed when the infusion pump receives a suspect signal, the suspect signal not matching the predetermined strength associated with a selected security mode.

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: 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 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. Methods, systems, and articles of manufacture for automatically detecting an occlusion in a medication infusion pump are provided. The electrical current to an infusion pump may be measured. Based on measurements of one or more variables, such as force, the infusion pump detects whether there is an occlusion in the system. The methods of detecting occlusions may be dynamic.

Abstract: A fluid infusion device is provided. The fluid infusion device can include a fluid reservoir having a barrel portion and a housing defining a receiving portion for removably receiving the fluid reservoir within the housing. The housing can have a first side including a first engagement system that cooperates with the barrel portion to bias the fluid reservoir relative to the housing in a direction substantially opposite a direction of fluid flow out of the fluid reservoir.

Abstract: A medical device module for use in a system with a remote programmer and/or a personal data assistant (PDA) with at least one medical device includes a housing, at least one medical device and a processor. The housing is adapted to couple with the PDA. The at least one medical device interface is coupled to the housing for interfacing with the at least one medical device. The processor is coupled to the at least one medical device interface to process data from the at least one medical device. The processor is also capable of interfacing with the PDA.