Described herein are wearable devices comprising a base coupled to a user, and a microneedle array supported by a base.

The application relates to a device (100) for non-invasively sampling interstitial fluid comprising one or more analytes from dermis (101 a) to skin surface (101 b) by using the magneto-hydrodynamic effect. The device comprises a first electrode (102a) and a second electrode (102b) adapted to be positioned adjacent to the skin surface, the first electrode separated from the second electrode by a distance (103), a power source (104) adapted to induce an electric current through the first electrode, the interstitial fluid and the second electrode, and also a magnet (105) adapted to produce a magnetic field to the interstitial fluid. Direction of the magnetic field and direction of the electric current produced by the magnet and the power source, respectively, is such that Lorentz force drives the fluid from the dermis towards the skin surface.

A wearable device for monitoring physiological changes in a patient is provided. The device can include a housing adapted to being secured to a patient's body, the housing comprising a needle configured for fluid contact with a bodily fluid under a skin surface; a chamber having a cell layer and configured to monitor physiological changes in the bodily fluid and to generate one or more signals associated with the physiological changes; and a reader for detecting and/or decoding signals from the cell layer to monitor physiological changes in the patient. The device is capable of engaging in a two-way communication with a second device through transmission of one or more signals.

Systems and methods are provided for determining levels of a target analyte in a biological sample. A transdermal sampling and analysis device may include a substrate, at least one disruptor mounted on the substrate, a reservoir configured to collect and contain a biological sample, at least two electrodes, and an electrochemical bioassay configured to determine levels of a target analyte in the biological sample. The at least one disruptor of the transdermal sampling and analysis device may be configured to generate a localized heat capable of altering permeability characteristics of a stratum corneum layer of skin of an organism.

The present disclosure is directed to microneedle patches for direct sampling and ultrasensitive detection of protein biomarkers in dermal interstitial fluids. The microneedle patches are comprised of polymers with high protein absorption capability (e.g. polystyrene) and are modified with capture biorecognition elements that are specific to target analytes in the interstitial fluid (ISF). Systems and methods are further provided for detection of a target ISF analyte obtained by in vivo sampling of the ISF using a microneedle patch.

A percutaneous microneedle monitoring system is provided with a substrate, a microneedle unit, a signal processing unit and a power supply unit, wherein the microneedle unit is created by stacking a plurality of metal sheets with protruding microneedle arrays on the substrate. Each sheet is provided with at least one perforation and the perforation edge is provided with a spur. Perforation on one sheet allows the spurs of the perforation edges to pass through at opposite positions on the remaining sheets, and the spurs are separated from each other. The microneedle unit is equipped with a signal processing unit to continuously detect the concentration changes of the various analytes appearing in the tissue fluid by fixing sensing polymer on the inner surface of protruding spur of the microneedle unit.

Fault detection and diagnostics for a microneedle array based continuous analyte monitoring device are provided. The electrochemical sensors, including the electrodes of the analyte monitoring device configured for measuring one or more target analytes, may experience various faults during use of the analyte monitoring device. By modeling the sensors as an electrical network, measurements of the electrical network may be correlated with operational parameters of the sensor. The voltage at the counter electrode provides an indication of the resistance or impedance between the working electrode and the counter electrode and is used to identify the occurrence of faults occurring at the continuous analyte monitoring device.

A device for biofluid processing and analysis includes a microfluidic module including multiple stacked layers, each layer of the stacked layers defines a respective conduit, and conduits of the stacked layers are interconnected to provide a flow path for a biofluid.

Method and apparatus for providing an integrated analyte sensor and data processing unit assembly is provided.

Various examples are provided related to interstitial fluid (ISF) or extracellular fluid (ECF) harvesting and processing. In one example, a microfluidic monitoring platform includes a microneedle patch including microneedles on a first side; an osmotic patch on a second side of the microneedle patch that includes glycerogel or hydrogel equilibrated with glycerin or glucose; and a microfluidic or fluid transport film or material channel between the osmotic patch and the microneedle patch. The channel can extract fluid from the osmotic-microneedle patch complex. In another example, a wearable electrochemical sensing system includes a monitoring platform including a microneedle-osmotic patch, a microfluidic or fluid transport film or material channel, and at least one sensor between the channel; and processing circuitry coupled to the at least one sensor. The processing circuitry can monitor presence of a chemical or biomarker in the fluid based upon signals obtained from the sensor.