Abstract: A method and system that enables a user to maintain a sensor in real time. The present invention involves performing a diagnostic Electrochemical Impedance Spectroscopy (EIS) procedure to measure sensor impedance value in order to determine if the sensor is operating at an optimal level. If the sensor is not operating at an optimal level, the present invention may further involve performing a sensor remedial action. The sensor remedial action involves reversing the DC voltage being applied between the working electrode and the reference electrode. The reversed DC voltage may be coupled with an AC voltage to extend its reach.

Abstract: This invention is a method for determining a concentration of an analyte. The steps include applying a potential excitation to a fluid sample containing an analyte, and measuring a current associated with the potential excitation at a plurality of time-points. The method also includes calculating an analyte concentration based on the measured current and a calibration curve, wherein the calibration curve is selected from a plurality of calibration curves and each calibration curve is associated with a time-segment selected from a plurality of time-segments.

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

Abstract: Biological reagent compositions with improved sensitivity to the concentration of blood glucose in patient samples for use in measuring systems and methods. The reagent compositions comprise a glucose oxidoreductase enzyme, a flavin nucleoside coenzyme and a mediator formulation. The mediator formulation comprises at least one electroactive organic molecule and at least one coordination complex.

Abstract: Determination of an analyte such as glucose in a sample is done making use of a plurality of electron transfer reagents, for example two electron transfer reagents, that work together to transfer electrons between the enzyme and the electrodes. The first electron transfer agent is a mediator that interacts with the enzyme after it has acted on the analyte to regenerate enzyme in its active form. The second electron transfer agent is a shuttle that interacts with the electrodes and optionally the mediator. The oxidation and reduction of the shuttle serves as the major source of current that is measured as an indication of analyte.

Abstract: The invention provides an implantable membrane for regulating the transport of analytes therethrough that includes a matrix including a first polymer; and a second polymer dispersed throughout the matrix, wherein the second polymer forms a network of microdomains which when hydrated are not observable using photomicroscopy at 400× magnification or less. In one aspect, the homogeneous membrane of the present invention has hydrophilic domains dispersed substantially throughout a hydrophobic matrix to provide an optimum balance between oxygen and glucose transport to an electrochemical glucose sensor.

Abstract: A biosensor can supply a sample solution accurately and easily, and includes a capillary for collecting a sample solution and analyzes a specific substance in the sample solution, an air hole, and at least two supply ports, i.e., a sample supply port and an auxiliary sample supply port, so that supply of the sample solution can be performed from either of the supply ports. Even when the sample supply port is closed up with a fingertip or the like and supply of the sample solution is stopped, the sample solution can be quickly supplied from the other auxiliary sample supply port.

Abstract: A biosensor that is capable of measuring a material contained in a sample is provided. The biosensor is configured to be inserted into a display device, and measures a material contained in the sample. The biosensor includes i) first and second substrates that are opposed to each other; ii) a sample guiding layer that has two sample injection openings and is located on the first substrate; iii) a first electrode that is located between the first substrate and the sample guiding layer; iv) a second electrode that is located between the second substrate and the sample guiding layer; v) a third electrode that is located between the sample guiding layer and the second substrate; and vi) a penetrated opening that penetrates the first substrate, the sample guiding layer, and the second substrate. The second electrode is spaced apart from the first electrode. The biosensor further includes i) a long edge, and ii) a short edge that shares a corner of the biosensor and neighbors the long edge.

Abstract: A biosensor can supply a sample solution accurately and easily, and includes a capillary for collecting a sample solution and analyzes a specific substance in the sample solution, an air hole, and at least two supply ports, i.e., a sample supply port and an auxiliary sample supply port, so that supply of the sample solution can be performed from either of the supply ports. Even when the sample supply port is closed up with a fingertip or the like and supply of the sample solution is stopped, the sample solution can be quickly supplied from the other auxiliary sample supply port.

Abstract: In vitro electrochemical sensors that provide accurate and repeatable analysis of a sample of biological fluid are provided. Embodiments include sensors that include a sample chambers having overhangs extending therefrom.

Abstract: Embodiments of the invention provide analyte sensors having elements designed to modulate their chemical reactions as well as methods for making and using such sensors. In certain embodiments of the invention, the sensor includes an analyte modulating membrane that comprises a blended mixture of a linear polyurethane/polyurea polymer, and a branched acrylate polymer.

Abstract: A system for more accurately measuring glucose in a sample includes a first glucose-sensing electrode incorporating a quantity of glucose oxidase, a second glucose-sensing electrode incorporating a quantity of PQQ-glucose dehydrogenase, a reference electrode, and means for selecting between a first glucose measurement made with the first glucose-sensing electrode and a second glucose measurement made with the second glucose-sensing electrode.

Abstract: Disclosed is a mobile communication terminal equipped with temperature compensation function for use in bio-information measurement, including a biosensor insertion in which a biosensor directly detecting bio-information of a subject is inserted, a temperature measurement unit measuring temperatures, and a controller analyzing the bio-information inputted from the biosensor based on stored analysis data and correcting the bio-information using the temperature measured by the temperature measurement unit, in which the temperature measurement unit measures temperature of a target object without contacting the target object directly.

Abstract: An analyte, system, strip and method are described. In one example, an analyte test strip is provided that includes a substrate, electrically conductive material and an isolated portion of the electrically conductive material. The substrate has a generally planar surface that extends from a first end to a second end. The electrically conductive material is disposed on the generally planar surface to define a plurality of electrodes spaced apart from each other. The isolated portion of the electrically conductive material is disposed between at least two electrodes so that the isolated portion is not in electrical communication with the plurality of electrodes.

Abstract: The present invention relates to an analytical tool (X1) including a first and a second plate elements (1, 3), a flow path (4) defined between the plate elements (1, 3) and an exhaust port (31) for discharging gas from the flow path (4). The exhaust port (31) is provided at the first plate element (3) and includes a portion which is offset in a thickness direction of the first plate element (3) from the main body (3A) of the first plate element (3). Preferably, the first plate element (3) includes a projection (51) integrally formed on the first plate element (3) and defining the exhaust port (31).

Abstract: Measurement of the series track resistance of a working and counter electrode pair in an electrochemical test strip provide error detection for multiple variations in the quality of the test strip, as well as the operation of strip in the test meter. In particular, a single measurement of series resistance can be used to detect and generate an error message when an incorrect reading is likely to result due to (1) damaged electrode tracks, (2) fouled electrode surfaces, (3) dirty strip contacts, or (4) short circuit between the electrodes.

Abstract: In vitro electrochemical sensors that provide accurate and repeatable analysis of a sample of biological fluid are provided. Embodiments include sensors that include a sample chambers having overhangs extending therefrom.

Abstract: A sensor including a sensing layer is disposed over an electrode or an optode and a layer-by-layer assembled mass transport limiting membrane disposed over the sensing layer. The membrane includes at least one layer of a polyanionic or polycationic material. The assembled layers of the membrane are typically disposed in an alternating manner. The sensor also optionally includes a biocompatible membrane.

Abstract: Generally, embodiments of the invention relate to analyte determining devices (e.g., electrochemical analyte monitoring systems) that include an indicator element that provides information relating to service history of the analyte determining devices, including, for example, previous use of the analyte determining devices. Also provided are systems and methods of using the, for example electrochemical, analyte determining devices in analyte monitoring.

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 a polymer membrane enhanced with cured epoxy resin for use as the outer membrane of biosensors. The membrane includes approximately 30-80% epoxy resin adhesives, 10-60% polymer such as poly(vinyl chloride), polycarbonate and polyurethane and 0-30% plasticizers and 5-15% surface modifier reagent such as polyethylene oxide-containing block copolymers. Utilizing the polymer membrane of the present invention, a three-layered sensing element has been developed. This sensing element will be particularly useful for miniaturized biosensors used for in vitro blood measurements or for continuous in vivo monitoring such as implantable biosensors. This element includes an enzyme layer, an interference-eliminating layer and the novel polymer member of the present invention as the outer polymer layer. This novel sensing element shows excellent response characteristics in solutions and has an extremely long lifetime.

Abstract: The present invention relates to an analytical instrument (1) which includes a flow path (5) for moving a sample containing blood cells, an introduction port (50) for introducing the sample into the flow path (5), a reagent portion (51) arranged in the flow path (5), and an electron detection medium (52) for obtaining information necessary for analyzing an analysis target component contained in the sample in relation with an amount of electrons transferred. The reagent portion (51) contains an electron mediator for supplying an electron taken from the analysis target component in the sample to the electron detection medium (52), and at least part of the reagent portion is positioned adjacent to the introduction port (50).

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

Abstract: The present invention relates to a method for measuring the concentration of a particular component in a blood sample containing blood cells based on a variable correlated with the concentration of the particular component. In the present invention, a concentration (S) in blood plasma obtained by removing blood cell components from the blood sample, a concentration (DI) in the blood sample computed by a differential method and a concentration (EP) in the blood sample computed by an equilibrium point method are expressed by a relational expression which is unrelated to the proportion of the blood cell components in the blood sample, and the concentration of the particular component is computed by using the relational expression.

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: The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host.

Abstract: The present invention relates to a biosensor comprising a substrate with a coating system in which a Ruthenium complex and an enzyme is integrated. The enzyme is able to convert bioproducts, e.g. glucose, fructose or glycerol. The depletion of oxygen during these converting reactions can be monitored via the fluorescence of the Ruthenium complex. The inventive biosensor can be used in biotechnological processes, e.g. the synthesis of biofuels.

Abstract: Embodiments of the present invention provide various multipolymers and permselective membranes for use with biosensors and other implantable medical devices and prostheses. Embodiments of the present invention may provide structural strength and integrity, and further may control the influx of glucose, oxygen and/or water. Embodiments of the present invention may, for example, minimize or reduce the influx of glucose by minimizing the percentage of hydrophilic segments, which in turn minimizes the percentage of water uptake and the degree of glucose transport.

Abstract: Membranes useful for amperometric sensors are described. The membranes allow continuous and real time in vivo measurements of a variety of redox active chemical species present in a fluid sample. In some embodiments, the membrane comprises a redox mediator, a redox reactive species, and conductive nano structures, such as carbon nanotubes. The membrane can be provided on a working electrode of the sensor. Amperometric sensors incorporating the membranes and methods of treatment using the sensors are also described.

Abstract: Biological reagent compositions with improved sensitivity to the concentration of blood glucose in patient samples for use in measuring systems and methods. The reagent compositions comprise a glucose oxidoreductase enzyme, a flavin nucleoside coenzyme and a mediator formulation. The mediator formulation comprises at least one electroactive organic molecule and at least one coordination complex.

Abstract: Disclosed are an apparatus and a method for determining whether or not a biosensor comprising two working electrodes and one reference electrode is well manufactured, and for rapidly and accurately quantifying a specific substance contained in a biological sample. The method comprises the steps of: sequentially supplying the respective working electrodes with power supply voltage; sequentially detecting the amounts of current flowing in the respective working electrodes by virtue of the supplied power supply voltage; re-supplying the two working electrodes with power supply voltage after a predetermined time to redetect the amounts of current flowing in the respective working electrodes; reading concentrations corresponding to the amounts of current detected from a memory, and calculating an average value from the read concentrations; and checking whether or not the concentrations read from memory are within a predetermined critical range to display an error message or the calculated average value.

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 interference domain.

Abstract: A polymer matrix that may coated on an electrode is created by co-crosslinking (1) an adduct of a polyaniline formed by templated oxidative polymerization on a polymer acid; (2) a water-soluble crosslinker; and (3) a redox enzyme. The polymer matrix may be hydrated, and the absorbed water may make it permeable to, for example, glucose. The polyaniline may be polyaniline itself or a substituted polyaniline; the water-soluble crosslinker may be poly(ethylene glycol) diglycidyl ether, and the redox enzyme may be glucose oxidase. The polymer matrix may be produced by co-crosslinking (1) an adduct of an electrically conductive polymer and a polymer acid; (2) a water-soluble crosslinker; and (3) a redox enzyme in a single step at an about neutral pH, curing by drying. After hydration, the crosslinked polymer matrix may form a 3-dimensional glucose-permeable bioelectrocatalyst, catalyzing the electrooxidation of glucose.

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 measuring an analyte in a subject are described. More particularly, devices for measurement of an analyte are disclosed incorporating a sensor comprising an enzyme layer in contact with an interference layer and a membrane comprising vinyl ester monomeric units covering at least a portion of the enzyme layer and at least a portion of the interference layer, the devices providing rapid and accurate analyte levels upon deployment.

Abstract: A BUN (blood urea nitrogen) sensor containing immobilized carbonic anhydrase and immobilized urease for the in vitro detection of urea nitrogen in blood and biological samples with improved performance and precision characteristics.

Abstract: The present invention provides a polymer membrane enhanced with cured epoxy resin for use as the outer membrane of biosensors. The membrane includes approximately 30-80% epoxy resin adhesives, 10-60% polymer such as poly(vinyl chloride), polycarbonate and polyurethane and 0-30% plasticizers and 5-15% surface modifier reagent such as polyethylene oxide-containing block copolymers. Utilizing the polymer membrane of the present invention, a three-layered sensing element has been developed. This sensing element will be particularly useful for miniaturized biosensors used for in vitro blood measurements or for continuous in vivo monitoring such as implantable biosensors. This element includes an enzyme layer, an interference-eliminating layer and the novel polymer member of the present invention as the outer polymer layer. This novel sensing element shows excellent response characteristics in solutions and has an extremely long lifetime.

Abstract: Disclosed herein is a device that functions as a glucose sensor. The device has a reference electrode; a counter electrode, a working electrode; an electrically conducting membrane; an enzyme layer; a semi-permeable membrane; a first layer of a first hydrogel in operative communication with the working electrode; the first layer of the first hydrogel being operative to store oxygen; wherein the amount of stored oxygen is proportional to the number of freeze-thaw cycles that the hydrogel is subjected to; and a second layer of the second hydrogel. Disclosed too is a method that comprises using periodically biased amperometry towards interrogation of implantable glucose sensors to improve both sensor's sensitivity and linearity while at the same time enable internal calibration against sensor drifts that originate from changes in either electrode activity or membrane permeability as a result of fouling, calcification and/or fibrosis.

Abstract: An immobilization carrier containing an electron acceptor compound is used in addition to glutaraldehyde and poly-L-lysine to immobilize an enzyme and an electron acceptor compound simultaneously to an electrode. For example, here are used diaphorase as the enzyme and 2-amino-3-carboxy-1,4-naphthoquinone (ACNQ) as the electron acceptor compound.

Abstract: An in vivo amperometric sensor is provided for measuring the concentration of an analyte in a body fluid. The sensor comprises a counter electrode and a working electrode, and the working electrode comprises a sensing layer which is generally water permeable and arranged on a support member adjacent to a contact pad. The sensing layer comprises an immobilized enzyme capable of acting catalytically in the presence of the analyte to cause an electrical signal. The sensing layer has an upper surface facing the body fluid and a lower surface facing away from the body fluid, and the immobilized enzyme is distributed within the sensing layer in such a way that the enzyme concentration in the middle between the upper and lower surfaces is at least as high as on the upper surface of the sensing layer.

Abstract: An electrochemical test sensor for detecting the analyte concentration of a fluid test sample includes a base, a dielectric layer, a reagent layer and a lid. The base provides a flow path for the test sample having on its surface a counter electrode and a working electrode adapted to electrically communicate with a detector of electrical current. The dielectric layer forms a dielectric window therethrough. The reagent layer includes an enzyme that is adapted to react with the analyte. The lid is adapted to mate with the base and to assist in forming a capillary space with an opening for the introduction of the test sample thereto. At least a portion of the width of the counter electrode is greater than the width of the working electrode.

Abstract: A biosensor that utilizes a mediator, i.e., an isomer of phenanthroline quinone, 1,10-phenanthroline-5,6-dione, and a metal ion, such as manganese, with an enzyme dependent upon NAD(P)+, such as, for example, glucose dehydrogenase, for improving the hematocrit bias and oxygen bias of biosensors. The electrodes of the biosensors employing this mediator and a metal ion provide an accurate clinical response over a hematocrit range that ranges from about 20% to about 70% and over an oxygen tension range that ranges from about 1 kPa to about 20 kPa.

Abstract: The present invention provides a sensor head for use in an implantable device that measures the concentration of an analyte in a biological fluid which includes: a non-conductive body; a working electrode, a reference electrode and a counter electrode, wherein the electrodes pass through the non-conductive body forming an electrochemically reactive surface at one location on the body and forming an electronic connection at another location on the body, further wherein the electrochemically reactive surface of the counter electrode is greater than the surface area of the working electrode; and a multi-region membrane affixed to the nonconductive body and covering the working electrode, reference electrode and counter electrode. In addition, the present invention provides an implantable device including at least one of the sensor heads of the invention and methods of monitoring glucose levels in a host utilizing the implantable device of the invention.

Abstract: A small diameter flexible electrode designed for subcutaneous in vivo amperometric monitoring of glucose is described. The electrode is designed to allow “one-point” in vivo calibration, i.e., to have zero output current at zero glucose concentration, even in the presence of other electroreactive species of serum or blood. The electrode is preferably layered, with the layers serially deposited within a recess upon the tip of a polyamide insulated gold wire. A first glucose concentration-to-current transducing layer can be overcoated with an electrically insulating and glucose flux limiting layer (second layer) on which, optionally, an immobilized interference-eliminating horseradish peroxidase based film is deposited. An outer layer is preferably biocompatible.

Abstract: An electrochemical glucose sensor comprising a base substrate, a conductive layer disposed on said base substrate, where said conductive layer comprises a reference electrode and at least two working electrodes; an insulation layer disposed on a part of said conductive layer, a reagent layer disposed on said working electrodes and on at least a part of said reference electrode, an adhesive layer disposed on a portion of said reagent layer and conductive layer wherein said adhesive layer substantially defines an area of said reference electrode which can be wetted by a liquid sample and said insulation layer substantially defines an area of said working electrodes which can be wetted by a liquid sample.

Abstract: The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous and subcutaneous measurement of glucose in a host.

Abstract: The present invention relates to electrochemical cells including a first working electrode 32, a first counter electrode 34, a second working electrode 36, and a second counter electrode 38, wherein the electrodes are spaced such that reaction products from the first counter electrode 34 arrive at the first working electrode 32, and reaction products from the first and second counter electrodes 34, 38 do not reach the second working electrode 36. Also provided is a method of using such electrochemical cells for determining the concentration of a reduced or oxidized form of a redox species with greater accuracy than can be obtained using an electrochemical cell having a single working and counter electrode.

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: Methods for covering an opening in an analyte meter are provided. Also provided are methods of determining analyte concentration.

Abstract: An electrochemical biosensor test strip with four new features. The test strip includes an indentation for tactile feel as to the location of the strips sample application port. The sample application port leads to a capillary test chamber, which includes a test reagent. The wet reagent includes from about 0.2% by weight to about 2% by weight polyethylene oxide from about 100 kilodaltons to about 900 kilodaltons mean molecular weight, which makes the dried reagent more hydrophilic and sturdier to strip processing steps, such as mechanical punching, and to mechanical manipulation by the test strip user. The roof of the capillary test chamber includes a transparent or translucent window which operates as a “fill to here” line, thereby identifying when enough test sample (a liquid sample, such as blood) has been added to the test chamber to accurately perform a test. The test strip may further include a notch located at the sample application port. The notch reduces a phenomenon called “dose hesitation”.