Abstract: A skin-adorned physiological or biochemical sensing device is disclosed herein. The device preferably comprises a first substrate and a second substrate. The first substrate comprises an array of solid microneedles designed to penetrate a biological interface to access a physiological fluid or tissue. Each microneedle is capable of electrical interface with the physiological fluid or tissue. The second substrate comprises integrated circuitry designed to transduce at least one signal produced by an electrophysiological or electrochemical reaction. A sensing device is formed that is capable of interpreting the signal arising from the electrophysiological or electrochemical reaction to ascertain the level of some physiological or biochemical entity.

Abstract: The present examples relate generally to apparatuses, systems, and methods for deploying a medical device to skin of a host. The medical device may comprise a transcutaneous analyte sensor applied to the skin of a host. The apparatuses, systems, and methods may be for reducing friction between a sensor and an insertion element and/or for controlling sensor deployment.

Abstract: The present examples relate generally to apparatuses, systems, and methods for deploying a medical device to skin of a host. The medical device may comprise a transcutaneous analyte sensor applied to the skin of a host. The apparatuses, systems, and methods may be for reducing friction between a sensor and an insertion element and/or for controlling sensor deployment.

Abstract: A method and device to impart the ability to selectively quantify chemical/biochemical analytes occupying physiological fluids via an automated process that allow the precise and spatially-defined simultaneous deposition of a thin-film of polymer containing an immobilized biorecognition element dispersed therein. A tissue penetrating electrochemical sensor comprises at least one working electrode and at least one of a reference electrode and a counter electrode.

Abstract: A device and method for the insertion of an analyte-selective microneedle array sensor into a dermal stratum of a user is disclosed herein. The device comprises a body portion, a recessed actuation portion, a carrier, a gating feature, and a disengagement feature. A user-directed application of a specified force to the actuation area causes the carrier to overcome the gating feature, thereby to effect the acceleration of the microneedle array sensor device towards the skin surface of a user with a specified impact force and velocity.

Abstract: A skin-adorned physiological or biochemical sensing device is disclosed herein. The device preferably comprises a first substrate and a second substrate. The first substrate comprises an array of solid microneedles designed to penetrate a biological interface to access a physiological fluid or tissue. Each microneedle is capable of electrical interface with the physiological fluid or tissue. The second substrate comprises integrated circuitry designed to transduce at least one signal produced by an electrophysiological or electrochemical reaction. A sensing device is formed that is capable of interpreting the signal arising from the electrophysiological or electrochemical reaction to ascertain the level of some physiological or biochemical entity.

Abstract: Devices and methods for low-latency analyte quantification enabled by the implementation of a microneedle-based analyte-selective sensor operating in the dermis or viable epidermis are disclosed herein. The sensing element of the device is contained within the microneedle-based analyte-selective sensor and configured to penetrate the stratum corneum of the skin and become positioned in the viable epidermis or dermis of the wearer such that the sensing element is located a spatial distance no greater than 500 micrometers from the plexus of the dermis of the wearer.

Abstract: A device and method for the coupling of an analyte-selective sensor and an infusion system into a singular body-worn device is disclosed herein. Following the coupling, information and/or power is/are exchanged between the two modalities (analyte-selective sensor and an infusion system) by means of a wireless electromagnetic transmission or an electrical connector. The analyte-selective sensor is configured to penetrate the stratum corneum to access the viable epidermis or dermis and measure the presence of an analyte. The infusion system is configured to penetrate the stratum corneum and deliver a solution-phase therapeutic agent.

Abstract: A device and method for the manual delivery of a therapeutic intervention in response to a physiological state of a user is disclosed herein. The device comprises a sensor, an infusion system, and a singular body-worn component. The sensor is configured to penetrate the stratum corneum to access the viable epidermis or dermis and measure the presence of an analyte. The infusion system is configured to deliver a solution-phase therapeutic agent based on an action of the user or a control algorithm.

Abstract: Ketoacidosis is a medical emergency that requires swift intervention to avert life-threatening sequel. A body-worn sensor (50) configured to measure the levels of a ketone compound circulating in a physiological fluid of a wearer and capable of generating an alert to the wearer if the level of the circulating ketone compound exceeds a pre-defined level or rate of change is disclosed herein. The sensor (50) preferably includes at least one of an electrochemical sensor, an optical sensor, a galvanic sensor, a voltammetric sensor, an amperometric sensor, a potentiometric sensor, an impedimetric sensor, a resistive sensor, a capacitive sensor, an ultrasonic sensor, a radio-frequency sensor, or a microwave sensor.

Abstract: A method and device to impart the ability to selectively quantify chemical/biochemical analytes occupying physiological fluids via an automated process that allow the precise and spatially-defined simultaneous deposition of a thin-film of polymer containing an immobilized biorecognition element dispersed therein. A tissue penetrating electrochemical sensor comprises at least one working electrode and at least one of a reference electrode and a counter electrode.

Abstract: A method and device to impart the ability to selectively quantify chemical/biochemical analytes occupying physiological fluids via an automated process that allow the precise and spatially-defined simultaneous deposition of a thin-film of polymer containing an immobilized biorecognition element dispersed therein. A tissue penetrating electrochemical sensor comprises at least one working electrode and at least one of a reference electrode and a counter electrode.

Abstract: A method (300) for constructing a solid-state reference electrode for use in an analyte-selective intracutaneously- or subcutaneously-implanted electrochemical cell is disclosed herein. The method (300) includes immersing a metallic electrode in a solution comprising a monomer precursor. The method (300) also includes applying a fixed or time-varying electrical potential or current to the metallic electrode, thereby serving to simultaneously electro-polymerize the monomer precursor and electro-deposit a conducting polymer, synthesized from the electro-polymerization of the monomer precursor, onto the said metallic electrode surface.

Abstract: A method and device to impart the ability to selectively quantify chemical/biochemical analytes occupying physiological fluids via an automated process that allow the precise and spatially-defined simultaneous deposition of a thin-film of polymer containing an immobilized biorecognition element dispersed therein. A tissue penetrating electrochemical sensor comprises at least one working electrode and at least one of a reference electrode and a counter electrode.

Abstract: A miniaturized sub-nanoampere sensitivity low-noise potentiostat system is disclosed herein. The system includes an adjustable bias analog front end/potentiostat, a plurality of high input impedance and high gain difference amplifiers, means for signal filtering, a high-resolution analog-to-digital converter, and a sampling algorithm.