Abstract: A method for factory calibration of a sensor of a CGM system is disclosed. A processor receives an enzyme membrane thickness after each dip of a working wire according to first parameters. The processor receives a glucose limiting membrane thickness after each dip of the working wire according to second parameters. The processor determines a working wire diameter, and includes the membrane thicknesses. The processor in communication with the CGM system, automatically generates a correlation between the first and the second parameters to at least one of a factory sensitivity and a drift profile. The drift profile predicts a sensitivity of the sensor over time. The processor associates the at least one of the factory sensitivity or the drift profile with the sensor. The sensor outputs a glucose reading during in-vivo use based on the at least one of the factory sensitivity or the drift profile.

Abstract: Devices and methods are described for providing continuous measurement of an analyte concentration. In some embodiments, the device has a sensing mechanism and a sensing membrane that includes at least one surface-active group-containing polymer and that is located over the sensing mechanism. The sensing membrane may have a bioprotective layer configured to substantially block the effect and/or influence of non-constant noise-causing species.

Abstract: A subcutaneous sensor for use with a continuous glucose monitor includes a working electrode and a reference electrode. The reference electrode comprises a reference substrate, an ion limiting layer over the reference substrate and a composition for releasing nitric oxide (NO). The composition has a NO release compound, a hydrophilic material and a hydrophobic material. A subcutaneous sensor for use with a continuous glucose monitor includes a reference electrode comprising a composition for releasing nitric oxide (NO). The composition has a NO release compound, a hydrophilic material and a hydrophobic material. The reference electrode is positioned separate from a working electrode.

Abstract: A subcutaneous sensor for use with a continuous glucose monitor includes a reference electrode, a working electrode, and a composition for releasing nitric oxide (NO). The reference electrode includes a reference substrate and an ion limiting layer over the reference substrate. The working electrode includes a conductive substrate, an interference layer over the conductive substrate, an enzyme layer over the interference layer, and a glucose limiting layer. The enzyme layer has an enzyme for reacting with in-vivo glucose in body fluid of a patient. The glucose limiting layer is over the enzyme layer and limits an amount of the in-vivo glucose from the body fluid of the patient that passes to the enzyme layer. The composition for releasing nitric oxide (NO) includes a NO release compound, a hydrophilic material and a hydrophobic material. The composition is on the reference electrode.

Abstract: Methods for coating a working wire for a continuous biological sensor include providing a plurality of wires in a fixture and dipping the plurality of wires into a coating solution according to parameters for a dipping process. A plurality of diameters is measured along a length of at least two coated wires of the plurality of wires in the fixture, using an automated measurement system, as in an in-line process. A controller that is in communication with the automated measurement system determines a thickness difference, the thickness difference being a difference between a thickness setpoint and an aggregate criteria for the plurality of diameters. The controller calculates adjusted parameters for the dipping process based on the thickness difference.

Abstract: Devices and methods are described for providing continuous measurement of an analyte concentration. In some embodiments, the device has a sensing mechanism and a sensing membrane that includes at least one surface-active group-containing polymer and that is located over the sensing mechanism. The sensing membrane may have a bioprotective layer configured to substantially block the effect and/or influence of non-constant noise-causing species.

Abstract: A subcutaneous sensor for use with a continuous glucose monitor includes a reference electrode, a working electrode, and a composition for releasing nitric oxide (NO). The reference electrode includes a reference substrate and an ion limiting layer over the reference substrate. The working electrode includes a conductive substrate, an interference layer over the conductive substrate, an enzyme layer over the interference layer, and a glucose limiting layer. The enzyme layer has an enzyme for reacting with in-vivo glucose in body fluid of a patient. The glucose limiting layer is over the enzyme layer and limits an amount of the in-vivo glucose from the body fluid of the patient that passes to the enzyme layer. The composition for releasing nitric oxide (NO) includes a NO release compound, a hydrophilic material and a hydrophobic material. The composition is on the reference electrode.

Abstract: Disclosed are devices for determining an analyte concentration (e.g., glucose). The devices comprise 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 an enzyme layer, wherein the enzyme layer comprises an enzyme and a polymer comprising polyurethane and/or polyurea segments and one or more zwitterionic repeating units. The enzyme layer protects the enzyme and prevents it from leaching from the sensing membrane into a host or deactivating.

Abstract: Disclosed are devices for determining an analyte concentration (e.g., glucose). The devices comprise 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 an enzyme layer, wherein the enzyme layer comprises an enzyme and a polymer comprising polyurethane and/or polyurea segments and one or more zwitterionic repeating units. The enzyme layer protects the enzyme and prevents it from leaching from the sensing membrane into a host or deactivating.

Abstract: Briefly, a sensor for a continuous biological monitor is provided for measuring the level of a target analyte for a patient. The sensor has a working wire and a reference wire, where the working wire has an analyte limiting layer that passes more than 1 in 1000 analyte molecules from the patient to the an enzyme layer. The enzyme layer has an enzyme entrapped in a polyurethane cross-linked with acrylic polyol. As free electrons are generated, a conductor transfers the electrons to the biological monitor. In some cases, the sensor may be constructed without the use of any expensive platinum.

Abstract: Described here are embodiments of processes and systems for the continuous manufacturing of implantable continuous analyte sensors. In some embodiments, a method is provided for sequentially advancing an elongated conductive body through a plurality of stations, each configured to treat the elongated conductive body. In some of these embodiments, one or more of the stations is configured to coat the elongated conductive body using a meniscus coating process, whereby a solution formed of a polymer and a solvent is prepared, the solution is continuously circulated to provide a meniscus on a top portion of a vessel holding the solution, and the elongated conductive body is advanced through the meniscus. The method may also comprise the step of removing excess coating material from the elongated conductive body by advancing the elongated conductive body through a die orifice.

Abstract: Disclosed are devices for determining an analyte concentration (e.g., glucose). The devices comprise 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 biointerface layer which interfaces with a biological fluid containing the analyte to be measured. The biointerface layer can comprises a biointerface polymer, wherein the biointerface polymer comprises polyurethane and/or polyurea segments and one or more zwitterionic repeating units. The sensing membrane can also comprise an enzyme layer, wherein the enzyme layer comprises an enzyme and a polymer comprising polyurethane and/or polyurea segments and one or more zwitterionic repeating units. The sensing membrane can also comprise a diffusion-resistance layer, which can comprise a base polymer having a lowest Tg of greater than ?50 C.

Abstract: Devices and methods are described for providing continuous measurement of an analyte concentration. In some embodiments, the device has a sensing mechanism and a sensing membrane that includes at least one surface-active group-containing polymer and that is located over the sensing mechanism. The sensing membrane may have a bioprotective layer configured to substantially block the effect and/or influence of non-constant noise-causing species.

Abstract: A working wire for a continuous biological sensor is disclosed and includes a substrate having a conductive surface and an enzyme layer formed on the conductive surface. The enzyme layer includes enzymes, an immobilization matrix and a polymeric crosslinking agent that crosslinks the enzymes and the immobilization matrix creating an enzyme immobilization network. A protective layer is included over the enzyme layer. A method for making the working wire for a continuous biological sensor is disclosed and includes combining an enzyme with a solvent creating an enzyme mixture. An immobilization matrix is mixed with the enzyme mixture. After the mixing, a polymeric crosslinking agent is combined with the enzyme mixture and the immobilization matrix creating a crosslinked mixture. The crosslinked mixture is allowed to stabilize. The stabilized crosslinked mixture is applied to the working wire, and the applied mixture is cured on the working wire.

Abstract: A glucose-specific sensor has a glucose limiting layer (GLL), an enzyme layer and an interference layer. The GLL comprises polyurethane with a molecular weight greater than 100,000 Daltons that is physically crosslinked with a water-soluble polymer having a molecular weight greater than 100,000 Daltons. The interference layer has a polymer formed from pyrrole, phenylenediamine (PDA), aminophenol, aniline, or combinations thereof. Methods for making a glucose-specific sensor include mixing a monomer with a solvent to form a monomer solution, applying the monomer solution to a substrate and electropolymerizing the monomer to form a polymer on the substrate. The polymer is an interference layer for the glucose-specific sensor. An enzyme layer is formed on the interference layer, and a glucose limiting layer is formed on the enzyme layer.

Abstract: In some embodiments, a method of manufacturing a metabolic sensor includes assembling a working wire for a metabolic sensor and exposing the interference layer to an oxidizing agent such as a gas. The assembly comprises forming an interference layer on a substrate, the substrate having an electrically conductive surface; forming an enzyme layer on the interference layer; and forming a glucose limiting layer on the enzyme layer. The exposing is performed prior to sterilizing the working wire.

Abstract: Devices and methods are described for providing continuous measurement of an analyte concentration. In some embodiments, the device has a sensing mechanism and a sensing membrane that includes at least one surface-active group-containing polymer and that is located over the sensing mechanism. The sensing membrane may have a bioprotective layer configured to substantially block the effect and/or influence of non-constant noise-causing species.

Abstract: Disclosed are devices for determining an analyte concentration (e.g., glucose). The devices comprise 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 biointerface layer which interfaces with a biological fluid containing the analyte to be measured. The biointerface layer can comprises a biointerface polymer, wherein the biointerface polymer comprises polyurethane and/or polyurea segments and one or more zwitterionic repeating units. The sensing membrane can also comprise an enzyme layer, wherein the enzyme layer comprises an enzyme and a polymer comprising polyurethane and/or polyurea segments and one or more zwitterionic repeating units. The sensing membrane can also comprise a diffusion-resistance layer, which can comprise a base polymer having a lowest Tg of greater than ?50 C.

Abstract: A working electrode for a subcutaneous sensor for use with a continuous biological monitor for a patient is disclosed. The working electrode includes a conductive substrate and a carbon-enzyme layer on the conductive substrate. The carbon-enzyme layer includes a polyurethane or silicone crosslinked with an acrylic polyol, and an enzyme fully entrapped by the polyurethane or silicone crosslinked with the acrylic polyol. The enzyme is selected according to a biological function to be monitored. The carbon-enzyme layer also includes a carbon material. The carbon-enzyme layer is electrically conductive and facilitates a generation of either peroxide or electrons within the carbon-enzyme layer responsive to reacting the enzyme with a target biologic from blood of the patient.

Abstract: A metabolic analyte sensor includes a substrate having an electrically conductive surface, an interference layer on the conductive surface, an enzyme layer on the interference layer, and a glucose limiting layer on the enzyme layer. The interference layer or the enzyme layer is configured such that the metabolic analyte sensor has an improved performance characteristic after sterilization compared to before sterilization. A packaged continuous metabolic monitor includes a sealed container; a metabolic sensor in the sealed container for insertion into a patient after the metabolic sensor is removed from the sealed container, the metabolic sensor comprising a conductive surface and an enzyme layer; electronic operating circuitry in the sealed container and coupled to the metabolic sensor; and a residue of a sterilizing gas in the metabolic sensor. The sealed container, the metabolic sensor and the electronic operating circuitry are sterilized together in the sealed container using the sterilizing gas.