Abstract: The present invention presents a method of fabrication for a physiological sensor with electronic, electrochemical, and chemical components. The fabrication method comprises steps for manufacturing an apparatus comprising at least one electrochemical sensor, a microcontroller, and a transceiver. The fabrication process includes the steps of substrate fabrication, circuit fabrication, pick and place, reflow soldering, electrode fabrication, membrane fabrication, sealing and curing, layer bonding, and dressing. The physiological sensor is operable to analyze biological fluids such as sweat.

Abstract: Systems and methods are provided for determining levels of a target analyte in a biological sample. A transdermal sampling and analysis device may include a substrate, at least one disruptor mounted on the substrate, a reservoir configured to collect and contain a biological sample, at least two electrodes, and an electrochemical bioassay configured to determine levels of a target analyte in the biological sample. The at least one disruptor of the transdermal sampling and analysis device may be configured to generate a localized heat capable of altering permeability characteristics of a stratum corneum layer of skin of an organism.

Abstract: A method for testing enzyme based electrochemical sensors wherein an electrochemical sensor is provided. A measurement setup is provided, which is operatively coupled to the electrochemical sensor, providing an output signal Z, e.g. a measured signal current, of the electrochemical sensor; and the electrochemical sensor is suitably contacted with a test solution comprising a certain concentration of the primary analyte. The electrochemical sensor is subjected to a certain swept range of temperatures T; an output signal Z is measured for different temperature values T; a derivative Z? of the output signal Z as a function of temperature T, or inverse temperature 1/T, is determined; and a relative derivate Z?/Z at a temperature T, or inverse temperature 1/T, is determined as the ratio between derivative Z? and output signal Z.

Abstract: The present application discloses improved multiple-use sensor arrays for determining the content of various species in samples of biological origin, in particular in the area of point-of-care (POC) testing for blood gases. The multiple-use sensor array is arranged in a measuring chamber, and the sensor array comprises two or more different ion-selective electrodes including a first ion-selective electrode (e.g. an ammonium-selective electrode being part of a urea sensor), wherein the first ion-selective electrode includes a membrane comprising a polymer and (a) a first ionophore (e.g. an ammonium-selective ionophore) and (b) at least one further ionophore (e.g. selected from a calcium-selective ionophore, a potassium-selective ionophore, and a sodium-selective ionophore), and wherein the first ionophore is not present in any ion-selective electrode in the sensor array other than in the first ion-selective electrode.

Abstract: A test strip includes a working electrode including a conductive layer and an electro-catalytic layer deposited on the conductive layer. A method for simultaneously detecting a glucose concentration and a percentage of glycated hemoglobin in a single test strip includes following steps: providing a blood sample, providing the aforementioned test strip, performing a sample injecting step, performing an initial step, performing a first detecting step, performing a second detecting step, performing a third detecting step, performing a first analyzing step, and performing a second analysis step.

Abstract: Described are sensors and methods of detecting hydrogen gas. The sensor includes a polymer matrix and a dye molecule in an amount sufficient such that exposure of the polymer matrix to hydrogen gas causes a change in a spectroscopic property of the dye molecule wherein the spectroscopic property includes at least one of color, absorbance, or luminescence. The polymer matrix may further include a catalyst, such as a transition metal, sulfonated Wilkinson's catalyst, colloidal Pt, sulfonated iridium cyclooctadiene triphenylphosphine, sulfonated rhodium cyclooctadiene triphenylphosphine, sulfonated ruthenium triphenylphosphine, or combinations thereof. Embodiments of the sensor may further include a gas permeable, water impermeable membrane, an outer covering, or combinations thereof.

Abstract: The present disclosure relates to multilayer constructs for producing metabolite strips. The multilayer constructs include a substrate layer having a top surface and a bottom surface, a thin film metal conductor layer formed on the top surface of the substrate layer and configured to act as an electrode, and a Transparent Conductive Oxide (TCO) protective layer deposited on top of the metal conductor layer. The metabolic strips can be used, along with various measuring devices, for determining the presence of certain analytes in a specimen and for various like applications.

Abstract: The present invention relates to a composition in which a conducting polymer is doped with a dopant, and a diagnostic apparatus, and more particularly, to a composition which is used to diagnose a disease and detect a biomaterial and also used for qualification and diagnosis by effectively and non-destructively collecting a captured biomaterial. Further, the composition can maximize capturing efficiency by being attached to a surface of a nano-structured scaffold and can be used as an ultrahigh-sensitive sensor using various linked bodies.

Abstract: A method and test element for electrochemically detecting at least one analyte in a sample are provided, wherein the method comprises: a) providing at least one test element comprising at least one first electrode contacting a test chemistry and at least one second electrode, wherein a surface of the second electrode consists of silver metal; b) contacting both the first and second electrodes with the sample comprising chloride ions; c) applying a first voltage between the first electrode as a cathode and the second electrode as an anode with a voltage sufficient for forming a layer of silver chloride at the surface of the second electrode; d) applying a second voltage between the first electrode as the anode and the second electrode as the cathode; and e) determining an electrical signal between the first and the second electrodes, whereby the analyte in the sample comprising the chloride ions is detected.

Abstract: The present invention presents a method of fabrication for a physiological sensor with electronic, electrochemical, and chemical components. The fabrication method comprises steps for manufacturing an apparatus comprising at least one electrochemical sensor, a microcontroller, and a transceiver. The fabrication process includes the steps of substrate fabrication, circuit fabrication, pick and place, reflow soldering, electrode fabrication, membrane fabrication, sealing and curing, layer bonding, and dressing. The physiological sensor is operable to analyze biological fluids such as sweat.

Abstract: The present invention relates generally to devices for measuring an analyte in a host. More particularly, the present invention relates to devices for measurement of glucose in a host that incorporate a cellulosic-based resistance domain.

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: Method and apparatus for receiving a first signal from a first working electrode of a glucose sensor positioned at a first predetermined position under the skin layer, receiving a second signal from a second working electrode of the glucose sensor positioned at a second predetermined position under the skin layer, the second signal received substantially contemporaneous to receiving the first signal, detecting a dropout in the signal level associated with one of the first or second signals, comparing the first signal and the second signal to determine a variation between the first and second signals, and confirming one of the first or second signals as a valid glucose sensor signal output when the determined variation between the first and the second signals is less than a predetermined threshold level are provided.

Abstract: Devices are provided for measurement of an analyte concentration, e.g., glucose in a host. The device can include a sensor configured to generate a signal associated with a concentration of an analyte; and a sensing membrane located over the sensor. The sensing membrane comprises a diffusion resistance domain configured to control a flux of the analyte therethrough. The diffusion resistance domain comprises one or more zwitterionic compounds and a base polymer comprising both hydrophilic and hydrophobic regions.

Abstract: Embodiments of the invention provide a dual insertion set for supplying a fluid to a body of a patient and for monitoring a body characteristic of the patient. Typical embodiments of the invention include a base, an infusion portion coupled to a first piercing member and a sensor portion coupled to a second piercing member. The infusion portion includes a cannula coupled to the first piercing member for supplying the fluid to a placement site. The sensor portion includes a sensor coupled to and extending from the base having at least one sensor electrode formed on a substrate and is coupled to the second piercing member in a manner that allows the sensor to be inserted at the placement site. The base is arranged to secure the dual insertion set to skin of the patient.

Abstract: A system for at least partial closed-loop control of a medical condition is disclosed. The system includes at least one medical fluid pump. The medical fluid pump including a sensor for determining the volume of fluid pumped by the pump. Also, at least one continuous analyte monitor, and a controller. The controller is in communication with the medical fluid pump and the at least one continuous analyte monitor. The controller includes a processor. The processor includes instructions for delivery of medical fluid based at least on data received from the at least one continuous analyte monitor.

Abstract: Luminescence test measurements are conducted using an assay module having integrated electrodes with a reader apparatus adapted to receive assay modules, induce luminescence, preferably electrode induced luminescence, in the wells or assay regions of the assay modules and measure the induced luminescence.

Abstract: A non-volatile memory device including at least a first electrode and a second electrode provided on a substrate, the first and second electrodes being separated from each other; an organic semiconductive polymer electrically connecting the first and second electrodes; an electrolyte in contact with the organic semiconductive polymer; and a third electrode that is not in contact with the first electrode, the second electrode, and the organic semiconductive polymer; wherein the organic semiconductive polymer has a first redox state in which it exhibits a first conductivity, and a second redox state in which it exhibits a second conductivity.

Abstract: The present invention presents a method of fabrication for a physiological sensor with electronic, electrochemical and chemical components. The fabrication method comprises steps for manufacturing an apparatus comprising at least one electrochemical sensor, a microcontroller, and a transceiver. The physiological sensor is operable to analyze biological fluids such as sweat.

Abstract: An infusion system includes an infusion device and a sensing device. The infusion system may further include a characteristic determining device. The infusion device also includes a communication system for transmitting to and receiving communications from the sensing device or a computer. The sensing device may sense an analyte of a bodily fluid of the user. The analyte may be calibrated using data from the infusion device and from a characteristic determining device. The system may be set up to automatically call for assistance when analytes reach a certain level.

Abstract: Methods are disclosed for measuring an analyte concentration in a fluidic sample. Such methods further allow one to provide an error code or correct and/or compensate for interferents such as an antioxidant before providing an analyte concentration. The measurement methods utilize information obtained from test sequences having at least one DC block, such as a slow-ramped bi-polar waveform, where a closed circuit condition is maintained during the DC block. The methods use information relating to status of a redox mediator feature during the electrochemical analysis to provide an antioxidant failsafe if the antioxidant is interfering with the analyte concentration. Also disclosed are devices, apparatuses and systems incorporating the various measurement methods.

Abstract: Membrane systems incorporating silicone polymers are described for use in implantable analyte sensors. Some layers of the membrane system may comprise a blend of a silicone polymer with a hydrophilic polymer, for example, a triblock poly(ethylene oxide)-poly(propylene oxide)-poly(ethylene oxide) polymer. Such polymeric blends provide for both high oxygen solubility and aqueous analyte solubility.

Abstract: Method and system for providing analyte sensor alignment and retention mechanism for improved connectivity with a transmitter unit for electrical connection, and further including transmitter unit contact pins with metal components to improve electrical conductivity with the analyte sensor in an analyte monitoring and management system is provided.

Abstract: In some aspects, an analyte sensor is provided for detecting an analyte concentration level in a bio-fluid sample. The analyte sensor may include one or more conductors received in a hollow portion of a hollow member. The first conductor may be made, at least in part, of a semiconductor material and an active region may be provided in contact with at least the first conductor. The analyte sensor may, in one aspect, include a lancet and an integrated sensor. Manufacturing methods and apparatus and systems utilizing the analyte sensors are provided, as are numerous other aspects.

Abstract: Embodiments of the invention include analyte-responsive compositions and electrochemical analyte sensors having a sensing layer that includes an analyte-responsive enzyme and a cationic polymer. Also provided are systems and methods of making the sensors and using the electrochemical analyte sensors in analyte monitoring.

Abstract: The present invention provides an electrochemical sensor comprising a substrate, an electrically conductive layer made of carbon particles which is disposed on the substrate, a cell membrane mimetic structure layer containing an enzyme at least one of inside the cell membrane mimetic structure layer and on the interface of the cell membrane mimetic structure layer which is disposed on the electrically conductive layer.

Abstract: A sensor utilizing a non-leachable or diffusible redox mediator is described. The sensor includes a sample chamber to hold a sample in electrolytic contact with a working electrode, and in at least some instances, the sensor also contains a non-leachable or a diffusible second electron transfer agent. The sensor and/or the methods used produce a sensor signal in response to the analyte that can be distinguished from a background signal caused by the mediator. The invention can be used to determine the concentration of a biomolecule, such as glucose or lactate, in a biological fluid, such as blood or serum, using techniques such as coulometry, amperometry, and potentiometry. An enzyme capable of catalyzing the electrooxidation or electroreduction of the biomolecule is typically provided as a second electron transfer agent.

Abstract: Electrochemical sensors for measurement of an analyte comprising an analyte sensing membrane comprising at least one salt of acetate ion, carbonate ion, bicarbonate ion, or mixtures thereof. Sensor testing methods comprising contacting an electrochemical sensor with an aqueous solution comprising at least one salt of acetate ion, carbonate ion, bicarbonate ion, or mixtures thereof and contacting the electrochemical sensor with one or more concentrations of analyte, the one or more concentrations of analyte being in the clinical concentration range of the analyte.

Abstract: Embodiments of the invention include analyte-responsive compositions and electrochemical analyte sensors having a sensing layer that includes an analyte-responsive enzyme and a cationic polymer. Also provided are systems and methods of making the sensors and using the electrochemical analyte sensors in analyte monitoring.

Abstract: A biosensor comprises a substrate; a reference electrode; a working electrode; a counter electrode; and a plurality of permeability adjusting spacers. The reference electrode, the working electrode and the plurality of permeability adjusting spacers are all being disposed to be substantially parallel to each other to create a plurality of enzyme containing porous sections. The enzyme containing porous sections contain an enzyme; where the enzyme is operative to react with a metabolite to determine the concentration of the metabolite. By combining a number of the aforementioned biosensors, the differential concentration of a target enzyme or protein is determined by monitoring the changes on its metabolite substrates.

Abstract: The present invention relates to an analytical tool (X1) to be mounted to an analytical apparatus (1) which includes a plurality of terminals (11, 12) and an analysis circuit (13). The analytical tool includes a plurality of electrodes (21, 22) coming into contact with the plurality of terminals (11, 12) when mounted to the analytical apparatus (1). In the analytical tool (X1), at least one (12) of the electrodes (21, 22) serves as a disturbing-noise countermeasure electrode to which disturbing noise is more likely to come in comparison with the other electrodes (11) than the above-mentioned electrode (12).

Abstract: A porous electroconductive material is provided. The electroconductive material enables efficient enzymatic metabolic reactions on electrodes and yields electrodes having immobilized enzymes thereon which remain stable in any working environment. The porous electroconductive material, which has a three-dimensional network structure, is formed from a skeleton of porous material and a carbonaceous material covering the surface of the skeleton. The porous material constituting the skeleton is foamed metal or alloy. This porous electroconductive material is made into an electrode, and enzymes are immobilized on this electrode. The resulting electrode with immobilized enzymes thereon is used as the anode of a bio-fuel cell.

Abstract: The present invention provides an electrochemical sensor having a sensing chemistry that operates substantially free of any “oxygen effect”. The electrochemical sensors are useful in determining the level of an analyte in a biological sample from a subject. The present invention also provides sensor assemblies including the electrochemical sensors as well as methods of using the same.

Abstract: Electrochemical devices, methods, and systems for detecting and quantifying analytes are disclosed. A chemical detection reagent is locally generated in a test solution by electrochemical reaction of a precursor compound caused to migrate into the test solution from a precursor solution separated from the test solution by a cell separator. This approach provides precise metering of the reagent, via the charge passed, and avoids the need to store a reagent solution that may be chemically unstable. In one embodiment, the starch concentration in a colloidal solution can be measured via spectroscopic detection of a blue complex formed by the interaction of starch with iodine produced, on demand, by electrochemical oxidation of iodide ion. The approach may also be used to characterize certain types of analytes. The invention is amenable to automation and is particularly useful for on-line monitoring of production processes, including the inclusion of feed back loop mechanisms for process control.

Abstract: The present invention provides methods and apparatuses for analyte detection.

Abstract: The invention concerns an electrochemical cell which, either alone or together which a substrate onto which it is placed, is in the form of a receptacle. The electrochemical cell contains a working electrode and a counter electrode, the working electrode being in a wall of the receptacle. At least one of the electrodes has at least one dimension of less than 50 ?m. The electrochemical cell is principally intended for use as a micro-electrode suitable for screening water, blood, urine or other biological or non-biological fluids.

Abstract: The present invention relates to electrochemical sensor strips and methods of determining the concentration of an analyte in a sample or improving the performance of a concentration determination. The electrochemical sensor strips may include at most 8 ?g/mm2 of a mediator. The strips, the strip reagent layer, or the methods may provide for the determination of a concentration value having at least one of a stability bias of less than ±10% after storage at 50° C. for 4 weeks when compared to a comparison strip stored at ?20° C. for 4 weeks, a hematocrit bias of less than ±10% for whole blood samples including from 20 to 60% hematocrit, and an intercept to slope ratio of at most 20 mg/dL. A method of increasing the performance of a quantitative analyte determination also is provided.

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: 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: The present invention provides reagent compositions, and analyte measuring devices and methods that utilize the reagent compositions.

Abstract: A measuring device for the detection and determination of the concentration of at least one analyte in a liquid medium consists of a polymeric carrier having biologically active specific binding molecules dried on its upstream portion. A multiple electrode set consisting of at least one reference electrode and at least one working electrode is located thereon in a downstream region. The working electrode is provided with biologically active specific binding molecules. The carrier has a sample application zone, which is adjoined, in the downstream direction, by a non-deformable, through-flow reaction and detection chamber, a variably dimensioned interstice, and a liquid absorption element. For a qualitative and quantitative analyte determination, two liquid media are applied in succession to the sample application zone. While the first can contain the wanted analyte, the second provides for the formation of an electrical signal.

Abstract: A water-miscible conductive ink for use in enzymatic electrochemical-based sensors includes a conductive material, an enzyme, a mediator and a binding agent. The conductive material, enzyme, mediator, and binding agent are formulated as a water-miscible aqueous-based dispersion wherein the binding agent becomes operatively water-insoluble upon drying.

Abstract: A bio-battery includes a biomolecular energy source, a first electrode and a second electrode. In some configurations, a bio-battery may also include a first cell containing the first electrode and the biomolecular energy source, and a second cell having a reducible substrate and the second electrode. The first cell can be in ionic communication with the second cell, for example by a proton exchange membrane. Various biomolecular energy sources can be used, including proton donor molecules or electrolytically oxidizable molecules. For example, the biomolecular energy source can be selected from the group consisting of Nicotinamide Adenine Dinucleotide (NADH), Nicotinamide Adenine Dinucleotide Phosphate (NADPH) and 5,10-Methylenetetrahydrofolate Reductase (FADH).

Abstract: The present invention relates to a method of non-covalently binding a compound to a sensor surface. The method comprises adsorbing a hydrophobin-like substance to at least a part of the sensor surface, such as an electrode. The invention further provides a sensor having a surface, at least a part of which is provided with a coating of a hydrophobin-like substance that comprises a non-covalently bonded compound.

Abstract: An improved disposable glucose test strip for use in a test meter of the type which receives a disposable test strip and a sample of blood from a patient and performs an electrochemical analysis using a non-conductive integrated reagent/blood separation layer (17) containing a filler, an enzyme effective to oxidize glucose, e.g., glucose oxidase, and a mediator effective to transfer electrons from the enzyme. The integrated layer formulation is printed over a conductive carbon element (16) to form a working electrode. The filler, for example a silica filler, is selected to have a balance of hydrophobicity such that on drying it forms a two-dimensional network on the surface of the conductive element. The response of this test strip is essentially temperature independent over relevant temperature ranges and is substantially insensitive to the hematocrit of the patient.

Abstract: The present invention relates generally to systems and methods for increasing oxygen generation in electrochemical sensors in order to overcome the oxygen limitations. The preferred embodiments employ electrode systems with at least two electrodes in relatively close proximity to each other; wherein at least one electrode is configured to generate oxygen and at least one other electrode is configured to sense an analyte or a product of a reaction indicative of the concentration of analyte. The oxygen generated by the oxygen-generating electrode is available to the catalyst within a membrane system and/or the counter electrode, thereby enabling the electrochemical sensors of the preferred embodiments to function even during ischemic conditions.

Abstract: The present invention provides a biosensor that enables highly-accurate measurement of a sample solution including a solid component like hemocytes and has a little variation in response. The biosensor includes: an insulating base plate, an electrode system having at least a working electrode and a counter electrode provided on the base plate, a cover member that is combined with the base plate to define a sample solution supply pathway for leading a sample solution from a sample supply unit to the electrode system, a reaction reagent system including at least an oxidation-reduction enzyme and an electron mediator, and a filter disposed between the electrode system and the sample supply unit in the sample solution supply pathway. The biosensor has a space that encircles surface of the filter in an area from one end of the filter close to the sample supply unit to the other end of the filter close to the electrode system.

Abstract: The present invention relates to an enzyme electrode useful for estimation of cholesterol in aqueous medium, said electrode comprising:

Abstract: A biosensor includes: an insulating base plate; an electrode system which is provided on the base plate and has a measurement electrode and a counter electrode; a reaction layer including at least oxidoreductase and an electron mediator; a sample solution supply pathway which includes the electrode system and the reaction layer and has an air aperture on the termination side thereof; a sample supply portion; and a filter which is disposed between the sample solution supply pathway and the sample supply portion and filters hemocytes, where plasma with the hemocytes therein filtered with the filter is sucked into the sample solution supply pathway due to capillarity, the central part of a secondary side portion of the filter is protruded into the sample solution supply pathway more than both the right and left ends thereof.

Abstract: There is provided a cholesterol sensor with high-accuracy and excellent response, whose object to be measured is whole blood, where plasma with which is obtained by filtering out hemocytes therein filtered in blood can rapidly reach an electrode system. In a biosensor where plasma with which is obtained by filtering out hemocytes therein filtered with by a filter is sucked into a sample solution supply pathway due to capillarity, there are formed: a first pressing part for holding a primary side portion of the filter from the bottom; a second pressing part for holding a secondary side portion of the filter from the top and the bottom; a third pressing part for holding the central portion of the filter from the top; and a void for surrounding the filter between the second pressing part and third pressing part.