Abstract: A sensor module is disclosed herein. The sensor module includes a skin piercing member carried by the carrier. The skin piercing member has a skin piercing end positioned opposite from a base end. The skin piercing member defines a lumen that extends along the central longitudinal axis from the skin piercing end toward the base end and the lumen having a lumen axis. The sensor module also includes a blood sample analysis zone located entirely within the lumen of the skin piercing member and a capillary flow stop for stopping capillary flow at a predetermined location within the lumen of the skin piercing member. The sensor module includes an elongated working electrode positioned within the lumen. The working electrode has a length that extends along the lumen axis where at least a section of the working electrode is positioned within the analysis zone. The working electrode includes sensing chemistry.

Abstract: The present disclosure relates to a sensor including an elongated member including at least a portion that is electrically conductive. The elongated member includes a sensing layer adapted to react with a material desired to be sensed. An insulating layer surrounds the elongated member. The insulating layer defines at least one access opening for allowing the material desired to be sensed to enter an interior region defined between the elongated member and the insulating layer. The insulating layer has an inner transverse cross-sectional profile that is different from an outer transverse cross-sectional profile of the elongated member. The difference in transverse cross-sectional profiles between the elongated member and the insulating layer provides channels at the interior region defined between the insulating layer and the elongated member. The channels extend generally along the length of the elongated member and are sized to allow the material desired to be sensed to move along the length of the sensor.

Abstract: A sensor can be manufactured by printing a working electrode onto a substrate using aerosol jet printing. Sensing chemistry (e.g., enzyme-based ink that including detection chemistry) also can be printed onto the working electrode using aerosol jet printing. A reference electrode also can be printed on the substrate at a position spaced along the substrate from the working electrode. In certain examples, the substrate can be positioned within a lumen of a skin piercing member of a sensor module.

Abstract: A sensor includes a sheath that is elongated along a longitudinal axis; a spacer positioned within the sheath and defining first and second channels having lengths that extend along the longitudinal axis; a first elongated member positioned within the first channel; and a second elongated member positioned within the second channel. The first elongated member includes an active surface forming a working electrode and the second elongated member including an active surface defining a counter electrode.

Abstract: A lactate sensor arrangement includes a catheter for withdrawing a test fluid sample, a sensor module for measuring an analyte such as lactate in the sample, and a pumping mechanism. A single uninterrupted flow path extends between the pumping mechanism and the catheter and within the flow path resides a sensor module containing a test chamber. The sensor arrangement also includes a control unit or controller that interfaces with a pumping mechanism driver. The sensor arrangement also includes a source of sensor calibration and anticoagulant solution, such as a reservoir, which has a silicone rubber fill septum, a non-woven Teflon air vent, and a check valve sub-assembly.

Abstract: Certain embodiments of a sensor cartridge element include a sensor module, an electrode arrangement installed on the sensor module, and a delivery arrangement securely coupled to the sensor module. The sensor module includes an analysis cell and a skin piercing member. The electrode arrangement generates an electrical signal when exposed to a fluid sample collected in the analysis cell. The delivery arrangement includes a drug reservoir, a piston chamber, and a valve arrangement providing selective fluid communication between the drug reservoir and the piston chamber. Metering electronics and an actuator can manage collection of fluid samples and/or dispensing of drug doses.

Abstract: A sensor module is disclosed herein. The sensor module includes a main housing defining an analysis zone within the housing. The sensor module also includes a skin piercing member mounted within the main housing. The skin piercing member is movable relative to the main housing between a retracted position and an extended position. The main housing of the sensor module defines a fluid sample flow passage that extends from a sampling end of the main housing to the analysis zone. The fluid sample flow passage includes a funnel structure through which the skin piecing member extends when in the extended position. The fluid sample flow passage also includes capillary flow enhancing slots that extend outwardly from opposite sides of the funnel structure.

Abstract: A sensor includes a sheath that is elongated along a longitudinal axis; a spacer positioned within the sheath and defining first and second channels having lengths that extend along the longitudinal axis; a first elongated member positioned within the first channel; and a second elongated member positioned within the second channel. The first elongated member includes an active surface forming a working electrode and the second elongated member including an active surface defining a counter electrode.

Abstract: The present disclosure relates to a sensor including an elongated member including at least a portion that is electrically conductive. The elongated member includes a sensing layer adapted to react with a material desired to be sensed. An insulating layer surrounds the elongated member. The insulating layer defines at least one access opening for allowing the material desired to be sensed to enter an interior region defined between the elongated member and the insulating layer. The insulating layer has an inner transverse cross-sectional profile that is different from an outer transverse cross-sectional profile of the elongated member. The difference in transverse cross-sectional profiles between the elongated member and the insulating layer provides channels at the interior region defined between the insulating layer and the elongated member. The channels extend generally along the length of the elongated member and are sized to allow the material desired to be sensed to move along the length of the sensor.

Abstract: A lactate sensor arrangement includes a catheter for withdrawing a test fluid sample, a sensor module for measuring an analyte such as lactate in the sample, and a pumping mechanism. A single uninterrupted flow path extends between the pumping mechanism and the catheter and within the flow path resides a sensor module containing a test chamber. The sensor arrangement also includes a control unit or controller that interfaces with a pumping mechanism driver. The sensor arrangement also includes a source of sensor calibration and anticoagulant solution, such as a reservoir.

Abstract: Certain processes for manufacturing an electrochemical sensor module include etching a Silicon wafer to form precursor sensor bodies, disposing sensor fibers along rows of the precursor sensor bodies, securing a rigid layer over the sensor fibers, dividing the wafer, rigid layer, and sensor fibers into individual precursor sensor bodies, and joining each precursor sensor body to a component body to form sensor modules.

Abstract: The present disclosure relates to a sensor including an elongated member including at least a portion that is electrically conductive. The elongated member includes a sensing layer adapted to react with a material desired to be sensed. An insulating layer surrounds the elongated member. The insulating layer defines at least one access opening for allowing the material desired to be sensed to enter an interior region defined between the elongated member and the insulating layer. The insulating layer has an inner transverse cross-sectional profile that is different from an outer transverse cross-sectional profile of the elongated member. The difference in transverse cross-sectional profiles between the elongated member and the insulating layer provides channels at the interior region defined between the insulating layer and the elongated member. The channels extend generally along the length of the elongated member and are sized to allow the material desired to be sensed to move along the length of the sensor.

Abstract: Certain embodiments of a sensor cartridge element include a sensor module, an electrode arrangement installed on the sensor module, and a delivery arrangement securely coupled to the sensor module. The sensor module includes an analysis cell and a skin piercing member. The electrode arrangement generates an electrical signal when exposed to a fluid sample collected in the analysis cell. The delivery arrangement includes a drug reservoir, a piston chamber, and a valve arrangement providing selective fluid communication between the drug reservoir and the piston chamber. Metering electronics and an actuator can manage collection of fluid samples and/or dispensing of drug doses.

Abstract: A sensor designed to determine the amount and concentration of analyte in a sample having a volume of less than about 1 ?L. The sensor has a working electrode coated with a non-leachable redox mediator. The redox mediator acts as an electron transfer agent between the analyte and the electrode. In addition, a second electron transfer agent, such as an enzyme, can be added to facilitate the electrooxidation or electroreduction of the analyte. The redox mediator is typically a redox compound bound to a polymer. The preferred redox mediators are air-oxidizable. The amount of analyte can be determined by coulometry. One particular coulometric technique includes the measurement of the current between the working electrode and a counter or reference electrode at two or more times. The charge passed by this current to or from the analyte is correlated with the amount of analyte in the sample. Other electrochemical detection methods, such as amperometric, voltammetric, and potentiometric techniques, can also be used.

Abstract: A sensor designed to determine the amount and concentration of analyte in a sample having a volume of less than about 1 ?L. The sensor has a working electrode coated with a non-leachable redox mediator. The redox mediator acts as an electron transfer agent between the analyte and the electrode. In addition, a second electron transfer agent, such as an enzyme, can be added to facilitate the electrooxidation or electroreduction of the analyte. The redox mediator is typically a redox compound bound to a polymer. The preferred redox mediators are air-oxidizable. The amount of analyte can be determined by coulometry. One particular coulometric technique includes the measurement of the current between the working electrode and a counter or reference electrode at two or more times. The charge passed by this current to or from the analyte is correlated with the amount of analyte in the sample. Other electrochemical detection methods, such as amperometric, voltammetric, and potentiometric techniques, can also be used.

Abstract: A sensor apparatus is disclosed herein. The sensor apparatus includes a flexible carrier that is elongated along a length of the carrier. The sensor apparatus also includes a plurality of analysis zones carried by the carrier. The analysis zones are spaced-apart from one another along the length of the carrier. The sensor apparatus further includes first and second spaced-apart electrodes carried by the flexible carrier. The first and second electrodes have lengths that extend along the length of the carrier. At least one of the first and second electrodes includes analyte sensing chemistry. The first and second electrodes extending across and contact the plurality of analysis zones.

Abstract: A process for the manufacture of small sensors with reproducible surfaces, including electrochemical sensors. One process includes forming channels in the surface of a substrate and disposing a conductive material in the channels to form an electrode. The conductive material can also be formed on the substrate by other impact and non-impact methods. In a preferred embodiment, the method includes cutting the substrate to form a sensor having a connector portion and a transcutaneous portion, the two portions having edges that define one continuous straight line.

Abstract: A sensor includes a sheath that is elongated along a longitudinal axis; a spacer positioned within the sheath and defining first and second channels having lengths that extend along the longitudinal axis; a first elongated member positioned within the first channel; and a second elongated member positioned within the second channel. The first elongated member includes an active surface forming a working electrode and the second elongated member including an active surface defining a counter electrode.

Abstract: Certain processes for manufacturing an electrochemical sensor module include etching a Silicon wafer to form precursor sensor bodies, disposing sensor fibers along rows of the precursor sensor bodies, securing a rigid layer over the sensor fibers, dividing the wafer, rigid layer, and sensor fibers into individual precursor sensor bodies, and joining each precursor sensor body to a component body to form sensor modules.

Abstract: An analyte monitor includes a sensor, a sensor control unit, and a display unit. The sensor has, for example, a substrate, a recessed channel formed in the substrate, and conductive material disposed in the recessed channel to form a working electrode. The sensor control unit typically has a housing adapted for placement on skin and is adapted to receive a portion of an electrochemical sensor. The sensor control unit also includes two or more conductive contacts disposed on the housing and configured for coupling to two or more contact pads on the sensor. A transmitter is disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor. The display unit has a receiver for receiving data transmitted by the transmitter of the sensor control unit and a display coupled to the receiver for displaying an indication of a level of an analyte.