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: 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: An apparatus for coating a working wire of a sensor includes a carousel, a robotic arm, and an optical scanner. The carousel includes a first platform, a second platform, and a ring dipping tool. The first platform has a central axis and supports a plurality of stations, all arranged around the central axis. The second platform is positioned above the first platform, with a platform actuator that raises, lowers, and rotates the second platform. The ring dipping tool is coupled to an edge of the second platform and oriented vertically with respect to ground and extending toward the first platform. The robotic arm is configured to transport a fixture, the fixture being configured to hold the wire. The optical scanner is positioned near a wire dipping station of the plurality of stations and configured to scan a position of the wire and a location of the ring dipping tool.

Abstract: Wound care coverings include a pad comprising a pad material, a lactate-based enzyme crosslinked with the pad material by a crosslinker, and a dye that changes color when H2O2 is present. In examples, an enzyme layer comprises a pad material crosslinked with a sugar-based enzyme by a crosslinker, a sugar-containing layer comprises a sugar in a hydrogel, and a rupturable barrier is between the enzyme layer and sugar-containing layer. In examples, a first enzyme layer comprises a first pad material, a lactate-based enzyme and a dye that changes color when H2O2 is present; a second enzyme layer comprises a second pad material crosslinked with a sugar-based enzyme by a second crosslinker; a sugar-containing layer comprises a sugar in a hydrogel, where the second enzyme layer is between the sugar-containing layer and the first enzyme layer; and a rupturable barrier is between the second enzyme layer and the sugar-containing layer.

Abstract: A method for metabolic monitoring includes a processor receiving data associated with an individual from a metabolic sensor, the data comprising at least two of glucose data, ketone data and lactate data. The processor receives food intake information and physical activity information associated with the individual. The processor calculates a global metric and determines an individualized metric by correlating the food intake and the physical activity information to the global metric. The processor recommends a behavior modification based on the individualized metric.

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: 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: A wire-based three-pole sensor for subcutaneous insertion includes a working electrode including a first split wire having a first flat surface, and a support sheet on the first flat surface. The first flat surface is created from a full wire having a circular cross-section with a portion removed. A reference electrode includes a second split wire having a second flat surface. The second flat surface is defined by a second chord across a circular cross-section of the second split wire. A counter electrode includes a third split wire having a third flat surface. The third flat surface is defined by a third chord across a circular cross-section of the third split wire. The second and third flat surfaces face each other. A cross-sectional diameter of the first split wire, the second split wire, and the third split wire coupled together is less than an inner diameter of an insertion needle.

Abstract: The sensor includes a working electrode having a first wire with a first flat surface and an electrochemical element on the first flat surface. A reference electrode includes a second wire with a second flat surface and a counter electrode includes a third wire with a third flat surface. The first wire is a first sensor wire for the working electrode, the second wire is a second sensor wire for the reference electrode and the third wire is a third sensor wire for the counter electrode in a plurality of sensor wires. The second flat surface and the third flat surface face toward each other.

Abstract: An apparatus includes a body and an actuator is coupled to the body. A needle is mounted to the actuator. The needle comprises a slot along a length to a tip. A sensor is coupled to a plurality of wires. A base is configured to be moveable by the actuator and includes a cutout, a circuit board having a microprocessor, and a plurality of contacts. Each contact is coupled to a wire of the plurality of wires. A power source is connected to the circuit board and to the base. A bracket is coupled to the bottom surface of the body and configured to receive the base. A patch is coupled to the bracket and has an adhesive. A needle is configured to be moveable by the actuator. The plurality of wires extend from the circuit board of the base, through the needle and out of the slot.

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: Briefly, a carbon working electrode is described that has a plastic substrate of polyethylene, polypropylene, polystyrene, polyvinyl chloride, or polylactic acid, and may be formed into an elongated wire. The carbon material coats the plastic substrate, and may be, for example, graphene, diamagnetic graphite, pyrolytic graphite, pyrolytic carbon, carbon black, carbon paste, or carbon ink, which is aqueously dispersed in an elastomeric material such as polyurethane, silicone, acrylates or acrylics. Optionally, selected additives may be added to the carbon compound prior to it being layered onto the plastic substrate. These additives may, for example, improve electrical conductivity or sensitivity, or act as a catalyst for target analyte molecules.

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.

Abstract: A working wire for a biological sensor is disclosed. The working wire includes a substrate comprising cobalt-chromium (Co—Cr) alloy or Nitinol alloy, a platinum layer comprising platinum on the substrate, and a membrane layer comprising a biological membrane applied over the platinum layer.

Abstract: Briefly, a sensor for a continuous biological monitor is provided that has a working electrode with an enhanced carbon-enzyme layer that in one embodiment is made by mixing an aqueous polyurethane emulsion with an acrylic polyol emulsion to make a base emulsion. An enzyme and carbon materials are added to the base emulsion, which is applied to the working electrode and cured. The carbon materials may include carbon and graphite to provide strength, as well as graphene or pyrolytic graphite to provide a desirable electrical resistance for the carbon-enzyme layer. Optionally, other additives can be added to the base emulsion prior to application, such as hydophiles, cross linkers, adding imodeoesters, hydroxysuccimide, carboldilite, melamines, epoxies, benzoyl peroxide or dicumyl peroxide.