Biolinq Incorporated

Described herein are variations of an analyte monitoring system, including an analyte monitoring device. For example, an analyte monitoring device may include an implantable microneedle array for use in measuring one or more analytes (e.g., glucose), such as in a continuous manner. Each microneedle of the microneedle array may include a microneedle body, an electrode material on the microneedle body, a biorecognition layer on the electrode material, a diffusion-limiting layer on the biorecognition layer, an interferent blocking agent, and/or an attachment enhancer between the biorecognition layer and the diffusion-limiting layer, where the interferent blocking agent and the attachment enhancer are configured to improve sensor sensitivity variability.

Aspects of the current subject matter are directed to a sensor assembly of an analyte monitoring device including one or more microneedle arrays. Aspects are directed to components and architecture of a sensor assembly to implement power and processing aspects of a microneedle array-based continuous analyte monitoring device for the detection and measuring of an analyte. A source of a power-on event is determined, and the analyte monitoring device is transitioned to a mode that corresponds to the determined source. When a power-on event is determined to be a valid power-on event, the analyte monitoring device is transition to a mode that corresponds to a type of the valid power-on event.

Described herein are variations of an analyte monitoring system, including an analyte monitoring device. For example, an analyte monitoring device may include an implantable microneedle array for use in measuring one or more analytes (e.g., glucose), such as in a continuous manner. Each microneedle of the microneedle array may include a microneedle body, an electrode material on the microneedle body, a biorecognition layer on the electrode material, a diffusion-limiting layer on the biorecognition layer, an interferent blocking agent, and/or an attachment enhancer between the biorecognition layer and the diffusion-limiting layer, where the interferent blocking agent and the attachment enhancer are configured to improve sensor sensitivity variability.

A method for circumscribing an insulating barrier region around a singular conductive microneedle structure or plurality of conductive microneedle structures adhered to a fixed substrate for the purpose of spatially defining a conduit for the routing of an electrical signal from the surface of said microneedle or microneedles to the posterior surface of the substrate is disclosed herein. A microneedle-based electrochemical biosensors structure comprises a substrate, a microneedle biosensor, a primary electrically conductive element, a secondary electrically conductive element and an electrically insulative annular barrier.

A system and method to confirm the insertion of an analyte-selective sensor comprising an array of microneedles possessing vertical extent between 200 and 2000 μm into viable tissue is disclosed herein. Mechanical insertion of an analyte-selective sensor is firstly attempted by means of an application of external force. Either during or following this routine, an electrical stimulus is applied between at least two distinct electrodes located within the said analyte-selective sensor; a resultant response is measured. This response is compared with a reference value to determine if insertion was successful. If insertion was successful, no further effort is required and the sensor can operate as intended. However, if insertion was not successful, the user can be instructed to continue to apply additional force to said sensor to achieve successful insertion or otherwise re-apply the said sensor altogether.

Aspects are directed to a reference electrode integrated on a surface of a substrate to facilitate functionalization of a working electrode. The reference electrode is used in the electrochemical deposition or electrodeposition of one or more functional layers on a working electrode. The working electrode may be a sensing element of an analyte-selective sensor. Additional aspects of the current subject matter are directed to a counter electrode integrated on a surface of a substrate.

Described herein are variations of an analyte monitoring system, including an analyte monitoring device. For example, an analyte monitoring device may include an implantable microneedle array for use in measuring one or more analytes (e.g., glucose), such as in a continuous manner. The microneedle array may include, for example, at least one microneedle including a tapered distal portion having an insulated distal apex, and an electrode on a surface of the tapered distal portion located proximal to the insulated distal apex. At least some of the microneedles may be electrically isolated such that one or more electrodes is individually addressable.

Described herein are variations of a sensor configured to generate a signal that is indicative of a concentration of an analyte in a fluid. The sensor may include a working electrode comprising an electrode material, a biorecognition layer disposed at least partially on the electrode material and comprising a biorecognition element that selectively and reversibly binds to an analyte, and an at least partially desiccated hydrogel disposed on the biorecognition layer. In some variations, the biorecognition element may be functionalized with a redox-active molecule and is configured to change conformation upon binding the analyte to move the redox-active molecule, closer to, or further from, the electrode material. In some variations, the biorecognition element may be an aptamer.

Aspects of the current subject matter are directed to a sensor assembly of an analyte monitoring device including one or more microneedle arrays. Aspects are directed to components and architecture of a sensor assembly to implement power and processing aspects of a microneedle array-based continuous analyte monitoring device for the detection and measuring of an analyte. A source of a power-on event is determined, and the analyte monitoring device is transitioned to a mode that corresponds to the determined source. When a power-on event is determined to be a valid power-on event, the analyte monitoring device is transition to a mode that corresponds to a type of the valid power-on event.

A method for circumscribing an insulating barrier region around a singular conductive microneedle structure or plurality of conductive microneedle structures adhered to a fixed substrate for the purpose of spatially defining a conduit for the routing of an electrical signal from the surface of said microneedle or microneedles to the posterior surface of the substrate is disclosed herein. A microneedle-based electrochemical biosensors structure comprises a substrate, a microneedle biosensor, a primary electrically conductive element, a secondary electrically conductive element and an electrically insulative annular barrier.