Abstract: Disclosed herein is a wearable device for continuous glucose monitoring including a housing having a top surface opposite a bottom surface. A portion of the top surface is moveable relative to the bottom surface. The bottom surface has an opening and is configured to secure directly to skin. A puck assembly has a sensor, a wire coupled to the sensor, and a plurality of contacts. A rigid member is configured to move relative to the bottom surface. An engagement member is configured to rotate about an axis. A cutting element is coupled to the engagement member. Displacement of the movable portion of the top surface moves the rigid member into contact with the engagement member. The cutting element rotates through the opening to form an incision in the skin then to a locked position within the housing. The sensor and the wire advance through the opening and into the incision.

Abstract: A method for fabricating a working electrode for a continuous biological monitor is disclosed. The method includes providing a substrate. A compound is prepared from an aqueous solution of a conductive carbon material, boronic acid and an electrophore, and an elastomeric material. The compound is applied to the substrate, and the compound is cured on the substrate to form a cured compound. A working electrode for a continuous biological monitor is disclosed. The working electrode includes a substrate and a cured compound disposed on the substrate. The cured compound includes a conductive carbon material, boronic acid and an electrophore, and an elastomeric material.

Abstract: Calibration for a biological sensor involves a holder coupled to a housing and configured to retain a wire-holding fixture that holds a working wire for the biological sensor. An electrical test board is coupled to the housing, wherein the electrical test board is configured with electronics of a continuous biological monitor and has an electrical contact configured to electrically connect to the working wire through the wire-holding fixture.

Abstract: Systems and methods for dip coating a working wire of a metabolic sensor include a dipping station having a container and a fluid monitoring device. The fluid monitoring device is positioned to detect a fluid level of a dipping solution in the container. The systems and methods may include a heater, a conveyor between the dipping station and the heater, an optical measurement tool, and a robot positioned to move the wire-holding fixture between the conveyor, optical measurement tool and dipping station. The robot may be configured to dip the working wire into the dipping solution. A controller may be communication with the dipping station and the robot, wherein the controller is configured to control i) a motion of the robot for dipping the working wire into the container based on the fluid level and ii) a dipping parameter based on the diameter measured by the optical measurement tool.

Abstract: Systems and methods for coating a working wire of a metabolic sensor include a chamber, a dipping station in the chamber, and a baffle configured to produce laminar flow over the dipping station. A controller is configured to activate the laminar flow during a dipping cycle at the dipping station, the dipping cycle including an insertion of the working wire into a dipping solution and a withdrawal of the working wire from the dipping solution. The baffle includes a first plate having first apertures of a first size and a second plate having second apertures of a second size, wherein the first plate is positioned over the second plate, with the second plate toward the dipping station.

Abstract: A system includes a wire-holding fixture configured to be received in an EP station. The wire-holding fixture comprises terminals, and each terminal is electrically coupled to a respective working wire of a plurality of working wires. The working wires extend away from the wire-holding fixture. A set of EP stations is included, and each EP station is configured to receive the wire-holding fixture. A container is configured to hold an electropolymerization solution and positioned beneath the EP station such that the working wires is immersible. A board comprising a plurality of electrical contacts is included, and each electrical contact is configured to electrically engage a corresponding terminal. A controller is configured to apply a voltage to the working wires through the respective terminals and electrical contacts to initiate electropolymerization of the material from the electropolymerization solution to form a polymer layer on each working wire.

Abstract: Systems for manufacturing a working wire for a continuous biological sensor include an automated measurement system configured to measure, as an in-line process with a dipping station, a plurality of diameters along a length of a working wire. Systems also include a controller in communication with the automated measurement system, wherein the controller is configured to determine a thickness difference, the thickness difference being a difference between a thickness setpoint and an aggregate criteria for the plurality of diameters. The systems may include the dipping station, that is configured to hold a coating solution, and may include a robot positioned to move the fixture to the automated measurement system.

Abstract: A method of manufacturing a working wire for a continuous glucose monitoring sensor includes receiving a substrate in a wound configuration. The substrate consists of a cobalt-chromium (Co—Cr) alloy. The substrate is unwound from the wound configuration. The substrate is allowed to naturally transition to a straight, linear configuration. A platinum layer is formed on the substrate. A membrane layer comprising a biological membrane is applied over the platinum layer. The working wire is formed to have a diameter in a range from 0.0025 inches to 0.005 inches. A working wire for a continuous glucose monitoring sensor includes a substrate consisting of a cobalt-chromium (Co—Cr) alloy, a platinum layer disposed on the substrate and a membrane layer comprising a biological membrane disposed over the platinum layer. A diameter of the working wire is in a range from 0.0025 inches to 0.005 inches.

Abstract: A method for making an enzyme membrane for a working electrode of a continuous biological monitor includes making an aqueous silicone dispersion and making an acrylic polyol emulsion. The silicone dispersion and the acrylic polyol emulsion are mixed to make a base emulsion. An enzyme is added to the base emulsion to create an enzyme/base emulsion dispersion. The enzyme is selected according to a biological function to be monitored. The enzyme/base emulsion dispersion is applied to the working electrode. The applied enzyme/base emulsion dispersion is cured.

Abstract: 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. The exposing is performed prior to sterilizing the working wire. The assembling 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.

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: 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: 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 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 an enzyme layer on the conductive substrate. The enzyme layer includes an enzyme, and the enzyme selected according to a biological function to be monitored. A hydrophobic material cross-linked with an acrylic polyol is included. The enzyme is fully entrapped in the cross-linked hydrophobic material with the acrylic polyol.

Abstract: A working wire of a continuous biological sensor is disclosed. The working wire includes a substrate for the sensor having a conductive surface. An enzyme layer is on the conductive surface and includes an enzyme, an immobilization matrix, and an enzyme immobilization network. The enzyme immobilization network is formed using a polymeric crosslinking agent and a non-polymeric crosslinking agent crosslinking the enzyme and the immobilization matrix. The polymeric crosslinking agent and the non-polymeric crosslinking agent are a combination of polyethylene glycol (PEG) dialdehyde and glutaraldehyde. A protective layer is over the enzyme layer.

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: Systems for manufacturing a working wire for a continuous biological sensor include an automated measurement system configured to measure, as an in-line process with a dipping station, a plurality of diameters along a length of a working wire. Systems also include a controller in communication with the automated measurement system, wherein the controller is configured to determine a thickness difference, the thickness difference being a difference between a thickness setpoint and an aggregate criteria for the plurality of diameters. The systems may include the dipping station, that is configured to hold a coating solution, and may include a robot positioned to move the fixture to the automated measurement system.

Abstract: A conductive substrate for a working electrode for a biological sensor includes a plastic substrate comprising an organic polymer or a thermoplastic. A carbon compound is on the plastic substrate. The carbon compound includes an elastomeric material and a carbon material from an aqueous solution. The carbon compound includes at least two materials from a group of carbon black, graphene, pyrolytic carbon, pyrolytic graphite, and diamagnetic graphite. The conductive substrate receives and transfers free electrons generated by an enzyme in the working 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: 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.