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 determining one or more signal characteristics associated with a subset of the measurements corresponding to a monitoring period, determining a reliability metric for the monitoring period based on the one or more signal characteristics, and providing indication of a maintenance condition when the reliability metric violates a threshold.

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 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 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: A glucose sensor product maintains the sterility of the glucose sensor while allowing gaseous manufacturing by-products to be vented from the inside of the glucose sensor package. An exemplary glucose sensor product includes a plastic package tray and a glucose sensor assembly in the plastic package tray. The glucose sensor assembly includes an electrochemical sensor with glucose oxidase enzyme, a sensor base formed at least in part from plastic, a sensor mounting pedestal formed at least in part from plastic, and a sensor introducer formed at least in part from plastic. The glucose sensor product also includes a microbial barrier material coupled to the plastic package tray to seal the glucose sensor assembly in the plastic package tray. The microbial barrier material maintains sterility of the glucose sensor assembly while venting substances outgassed from the plastic package tray, the sensor base, the sensor mounting pedestal, and the sensor introducer.

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: Disclosed are methods, apparatuses, etc. for glucose sensor signal reliability analysis.

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: 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 flexible mounting base to hold a sensor at an infusion site, the sensor being a removable in vivo sensor for monitoring analyte concentration level in a patient, such as blood glucose (BG) level. The mounting base comprises a flexible adhesive that anchors the flexible sensor set at an infusion site to provide stability for the sensor set in a convenient and comfortable manner. Placement of the mounting base onto the patient's skin causes the insertion needle to pierce the skin for transcutaneous placement of the cannula with the sensor therein. The insertion needle can then be withdrawn to leave the cannula and sensor at the selected insertion position, with the distal segment of the sensor being exposed to patient extracellular fluid via apertures formed in the cannula.

Abstract: Disclosed are methods, apparatuses, etc. for glucose sensor signal reliability analysis.

Abstract: The invention pertains to analyte sensors designed to include layered compositions that provide these sensors with enhanced functional and/or material properties including, for example, resistance to damage caused by ethylene oxide during sterilization processes. Embodiments of the invention include polyvinyl alcohol N-methyl-4(4?-formylstyryl)pyridinium (SbQ) polymer materials and methods for employing such materials during the ethylene oxide sterilization of glucose sensors.

Abstract: Embodiments of the invention provide analyte sensors formed from layered materials that include polymeric enzyme compositions selected to provide advantageous material properties, 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: Disclosed are a system and method for determining a metric and/or indicator of a reliability of a blood glucose sensor in providing glucose measurements. In one aspect, the metric and/or indicator may be computed based, at least in part, on an observed trend associated with signals generated by the blood glucose sensor.

Abstract: An apparatus for sensing multiple parameters includes an implantable housing and a plurality of implantable sensors disposed within the implantable housing. The plurality of implantable sensors sense parameters in a patient, such as biological or physiological parameters, for example, and each responds to an analyte in the patient. The plurality of implantable sensors may include, but is not limited to, electrochemical, potentiometric, current and optical sensors.

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: Disclosed are a system and method for determining a metric and/or indicator of a reliability of a blood glucose sensor in providing glucose measurements. In one aspect, the metric and/or indicator may be computed based, at least in part, on an observed trend associated with signals generated by the blood glucose sensor.