Abstract: Techniques disclosed herein relate to determining a calibrated measurement value indicative of a physiological condition of a patient using sensor calibration data and a performance model. In some embodiments, the techniques involve obtaining one or more electrical signals from a sensing element of a sensing arrangement, where the one or more electrical signals are influenced by a physiological condition in a body of a patient. The techniques also involve obtaining calibration data associated with the sensing element from a data storage element of the sensing arrangement, converting the one or more electrical signals into one or more calibrated measurement parameters using the calibration data, obtaining a performance model associated with the sensing element, obtaining personal data associated with the patient, and determining, using the performance model and based on the personal data and the one or more calibrated measurement parameters, a calibrated output value indicative of the physiological condition.

Abstract: This disclosure generally relates to medical devices that include a sensor transmitter assembly that includes a sensor assembly including a sensor module where a first sensor including a first sensor head having at least one first sensor contact pad is combined with a second sensor including a second sensor head having at least one second sensor contact pad. The sensor transmitter assembly also includes a transmitter assembly positioned on a top of the sensor assembly to form a single unit, the transmitter assembly having at least one transmitter contact disposed on a base of the transmitter assembly, where the first sensor contact pad(s) and the second sensor form a connection path with the transmitter contact(s).

Abstract: A biocompatible medical device may include an electrochemical sensor including a common reference electrode; at least one counter electrode; and a work electrode platform comprising a plurality of respective work electrodes, each respective work electrode electrically coupled to the common reference electrode and comprising a respective reagent substrate configured to react with a respective analyte to produce a respective signal indicative of a concentration of the respective analyte; and processing circuitry operatively coupled to the electrochemical sensor, and configured to receive from the electrochemical sensor a plurality of signals from the plurality of respective work electrodes; identify the respective signal corresponding to a respective selected work electrode; and process the identified signal to determine the concentration of the respective analyte associated with the respective selected work electrode.

Abstract: An example device includes an electrochemical cell configured to generate a first electrical signal indicative of an amount of glucose in a fluid of a person, the electrochemical cell comprising a working electrode, a counter electrode, and a reference electrode; and a background electrode configured to not catalyze a reaction with glucose and is configured to generate a second electrical signal indicative of an amount of electrochemical interference proximate the electrochemical cell.

Abstract: A fluid infusion system includes a housing configured to be adhesively coupled to an anatomy of a user, and a tube configured to extend from the housing for insertion into the anatomy of the user. The tube includes a plurality of conduits defined within the tube. The plurality of conduits include a fluid delivery conduit configured to facilitate a fluidic connection between a fluid source and the anatomy of the user, and one or more conduits configured to accommodate a plurality of electrodes for determining a physiological characteristic of the user.

Abstract: A biocompatible medical device may include an electrochemical sensor including a common reference electrode; at least one counter electrode; and a work electrode platform comprising a plurality of respective work electrodes, each respective work electrode electrically coupled to the common reference electrode and comprising a respective reagent substrate configured to react with a respective analyte to produce a respective signal indicative of a concentration of the respective analyte; and processing circuitry operatively coupled to the electrochemical sensor, and configured to receive from the electrochemical sensor a plurality of signals from the plurality of respective work electrodes; identify the respective signal corresponding to a respective selected work electrode; and process the identified signal to determine the concentration of the respective analyte associated with the respective selected work electrode.

Abstract: Embodiments of the invention provide optimized sputtered metallic surfaces adapted for use with implantable medical devices as well as methods for making and using such polymeric surfaces. These sputtered metallic surfaces have features that function to inhibit or avoid an inflammatory immune response generated by implantable medical devices. Typical embodiments of the invention include an implantable glucose sensor used in the management of diabetes having a sputtered metallic surface adapted to contact an in vivo environment.

Abstract: Medical devices and related systems and methods are provided. A method of controlling medication delivery based on sensor input involves obtaining a measurement parameter representing an electrical response of a first instance of a sensing element to a physiological condition of a person. The measurement parameter is converted into a calibrated measurement parameter using calibration data specific to the first instance of the sensing element. The method further involves determining a measurement value using the calibrated measurement parameter as input to a performance model. The performance model is derived from historical calibrated measurement parameters and corresponding reference values. The historical calibrated measurement parameters are from other instances of the sensing element. A command is then determined based on the measurement value and sent to a medical device. The command causes the medical device to deliver a dose of medication influencing the physiological condition of the person.

Abstract: The invention provides amperometric analyte sensor systems comprising one or more electrodes designed to monitor in vivo levels of 3-hydroxybutyrate (and optionally glucose as well) in order to facilitate the management of diabetic ketoacidosis. The invention further includes dual layer membrane compositions, elements and methods useful with such amperometric analyte sensor systems.

Abstract: Medical devices and related systems and methods are provided. A method of calibrating an instance of a sensing element involves obtaining fabrication process measurement data from a substrate having the instance of the sensing element fabricated thereon, obtaining a calibration model associated with the sensing element, determining calibration data associated with the instance of the sensing element for converting the electrical signals into a calibrated measurement parameter based on the fabrication process measurement data using the calibration model, and storing the calibration data in a data storage element associated with the instance of the sensing element.

Abstract: A fluid infusion system includes a housing configured to be adhesively coupled to an anatomy of the user. The housing comprises a communication device configured to wirelessly communicate a physiological characteristic to a communication component of a fluid infusion device. The fluid infusion system includes a fluid flow path from the fluid infusion device into the anatomy of the user, and the fluid flow path is configured to extend from the housing for insertion into the anatomy of the user.

Abstract: Embodiments of the invention provide optimized sputtered metallic surfaces adapted for use with implantable medical devices as well as methods for making and using such polymeric surfaces. These sputtered metallic surfaces have features that function to inhibit or avoid an inflammatory immune response generated by implantable medical devices. Typical embodiments of the invention include an implantable glucose sensor used in the management of diabetes having a sputtered metallic surface adapted to contact an in vivo environment.

Abstract: The invention provides amperometric analyte sensor systems comprising one or more electrodes designed to monitor in vivo levels of 3-hydroxybutyrate (and optionally glucose as well) in order to facilitate the management of diabetic ketoacidosis. The invention further includes compositions, elements and methods useful with such amperometric analyte sensor systems.

Abstract: Techniques disclosed herein relate to determining a calibrated measurement value indicative of a physiological condition of a patient using sensor calibration data and a performance model. In some embodiments, the techniques involve obtaining one or more electrical signals from a sensing element of a sensing arrangement, where the one or more electrical signals are influenced by a physiological condition in a body of a patient. The techniques also involve obtaining calibration data associated with the sensing element from a data storage element of the sensing arrangement, converting the one or more electrical signals into one or more calibrated measurement parameters using the calibration data, obtaining a performance model associated with the sensing element, obtaining personal data associated with the patient, and determining, using the performance model and based on the personal data and the one or more calibrated measurement parameters, a calibrated output value indicative of the physiological condition.

Abstract: A single flex double-sided electrode useful in a continuous glucose monitoring sensor. In one example, a counter electrode is placed on the back-side of the flex and a work electrode is placed on the top-side of the sensor flex. The electrode is fabricated on physical vapor deposited metal deposited on a base substrate. Adhesion of the electrode to the base substrate is carefully controlled so that the electrode can be processed on the substrate and subsequently removed from the substrate after processing.

Abstract: A single flex double-sided electrode useful in a continuous glucose monitoring sensor. In one example, a counter electrode is placed on the back-side of the flex and a work electrode is placed on the top-side of the sensor flex. The electrode is fabricated on physical vapor deposited metal deposited on a base substrate. Adhesion of the electrode to the base substrate is carefully controlled so that the electrode can be processed on the substrate and subsequently removed from the substrate after processing.

Abstract: A method of testing one or more analyte sensors each comprising a first electrode; a second electrode; and a material layer disposed on or above the first electrode; the method including (a) applying a voltage potential to the first electrode with respect to the second electrode; (b) measuring a test signal comprising an output current from the first electrode that results from the application of the voltage potential; (c) using the test signal from (b) to observe an electrical characteristic of the analyte sensor; and (d) correlating the electrical characteristic a parameter associated with an electrochemical response of the analyte sensor to an analyte, wherein the testing is under dry conditions without exposure of the electrodes to a fluid containing the analyte or an in-vivo environment containing the analyte.

Abstract: Medical devices, systems and methods are provided.

Abstract: Embodiments of the invention provide methods and materials for making analyte sensors having a plurality of layered elements such as amperometric glucose sensors that are used by diabetic individuals to monitor blood sugar concentrations. Embodiments of the invention utilize plasma deposition technologies to form thin films of hexamethyldisiloxane useful in such sensors. Sensors that incorporate the thin film compositions formed by these processes exhibit a number of desirable characteristics.

Abstract: The invention includes method and materials designed to measure the material properties (e.g. thickness) of layers of material in a sensor using non-Faradaic EIS (Electrochemical Impedance Spectroscopy) methods. The methods are non-destructive, very sensitive and rapid. Typically in these methods, an AC voltage is applied to the desired material layer while the output current and therefore impedance is measured. This voltage can be applied in multiple frequencies in sweep mode in order to detect both the material and, for example, the thickness of the target material. In this way, EIS allows the characterization of properties of various layers of material disposed in devices such as electrochemical glucose sensors.