Provided herein are systems and methods that use an electrochemical aptamer-based (EAB) biosensor to detect a plurality of hormone and/or analyte that can be used for fertility and pregnancy monitoring.

Provided in the present invention are a flexible electrochemical electrode, a subcutaneous continuous glucose monitoring sensor equipped with the electrochemical electrode, and a preparation method thereof. The electrode directly uses gold layers on both sides of a chemically plated film, respectively as a working electrode and a reference-counter electrode, so as to form an electrochemical two-electrode system. Petaloid platinum nanoparticles are electrodeposited on a surface of the configured working electrode as a catalytic layer; a carbon nanotube/Nafion mesh layer functions as an anti-interference layer, and is formed thereon with an enzyme biochemical sensitive layer by means of electrostatic adsorption, after crosslinking and curing in glutaraldehyde, polyurethane mass transfer is coated to limit a protection layer, so as to prepare a flexible continuous glucose monitoring sensor. The sensor does not require photolithography, screen printing or other technologies to construct an electrochemical electrode system. The present invention effectively simplifies the processing technology, can easily achieve large-scale production and reduce production costs; and meanwhile, the present invention has characteristics such as a wide linear range, low detection limit, powerful anti-interference capacity, high response sensitivity and long-term stability.

Disclosed are systems, devices and methods for continuous and simultaneous monitoring of multiple analytes within interstitial fluid by an integrated system for a microneedle array sensor platform. In some aspects, the device includes a microneedle array sensor unit, an electronics unit and a housing structure. The electronics unit is in electrical communication with an array of electrode probe structures via an array of surface-mount, spring loaded pins, and the electronics unit includes a power source, a data processing unit, and a wireless transmitter. The housing structure is configured to encase, at least partially, the microneedle array sensor unit and the electronics unit, where the array of microneedles is exposed from a side of the housing structure. The device can be configured as a patch worn on skin of a patient user.

Microneedle electrodes for detecting targets or sensing pH are described. The microneedles may be made of a hydrogel, a probe coupled to the hydrogel for generating an electrochemical signal in the presence of the target, and a conductive material for communicating the electrochemical signal through the hydrogel. The hydrogel microneedles may be used for in-situ detection of targets, such as biomolecules found in interstitial fluid. Also described are methods of producing hydrogel microneedles, articles and apparatus comprising microneedle electrodes, and methods and uses of the same. The microneedle electrodes may be used for biosensing, such as in transdermal patches for detecting biomarkers in a subject. The biosensors may be used for continuous, real-time tracking of targets in-situ, without requiring further reagents or processing steps.

The present disclosure provides an electrode substrate including an insulating substrate having, on a surface thereof, a region where at least one fine uneven structure is formed and a plurality of smooth regions separated by the fine uneven structure; and a conductive thin film formed on the entire of at least one surface of the insulating substrate where the fine uneven structure is formed. According to the present disclosure, the conductive region and the insulating region can be simultaneously formed on the insulating substrate only by forming the conductive thin film in a single step on the entire surface of the single insulating substrate on which the fine uneven structure is formed.

In one aspect, a dermal patch is disclosed, which comprises at least a pair of sensing units each configured for detecting at least one analyte in a physiological sample, at least one microneedle configured for puncturing the skin to allow collection of the physiological sample, and a selector device for selecting any one of said sensing units for receiving at least a portion of said collected physiological sample for analysis thereof.

A biosensor assembly that measures multiple physical parameters is disclosed. The biosensor assembly includes a first implantable probe and a first skin contacting electrode. Wherein a first physiological parameter is measured between the first implantable probe and the first skin contactable electrode.

A software library for providing a uniform framework for various applications or third-party applications access to sensor data. The system further includes a sensor control module and a remote management module. The sensor control module includes logic for communicating with the sensors and receiving sensor data and to communicate that sensor data to the remote management module or various applications. The sensor control module may include a user interface that may display a banner containing numerous components. The content of the banner may differ depending on the host application. The system may further include a host application that incorporates the banner.

The present invention relates to a sensor preparation assembly (30) for a body monitoring system, the sensor (30) comprising at least one needle, the preparation assembly comprising: a bag (26) comprising a volume of a preparation solution, the bag (26) being configured to be positioned under the sensor (30) and being configured to be pierced by the needle (32), a receptacle (28) on which the bag is arranged (26), bearing means (24) that arc movable in relation to the receptacle (28) toward a bearing position, the bearing means (24) in the bearing position being configured to cause the sensor (30) to pierce the bag (26). The invention further relates to a sensor preparation method, comprising the placement of the sensor (30) in a position that is interposed between the bearing means (24) and the bag (26), the needle (32) of the sensor (30) piercing the bag (26).

An applicator for an analyte monitoring device may include an actuatable housing having a body defining a cavity therein and having a distal opening and a side opening. A cuff and a shuttle are received within the cavity and are separately translatable relative to the housing body. A base may removable engage the housing body at the distal opening. The housing body, the cuff, the shuttle, and/or the base may be engaged with one another with one or more releasable coupling features. The base may be removed from an engagement with the housing body, causing the cuff and the shuttle to be aligned and positioned in a configuration in which the analyte monitoring device, held by the shuttle, is ready for insertion into the skin.