The present invention relates to a method of a method of measuring a human body analyte concentration in an interstitial fluid, comprising the step of measuring a first electrical current I.sub.1 between a working electrode and a pseudo-reference electrode while applying a first potential between the working electrode and the pseudo-reference electrode, the first potential being less than a threshold potential, the magnitude of the first electrical current being greater than the magnitude of a predetermined first threshold current, and further measuring an output electrical current between the working electrode and the pseudo-reference electrode while applying a second electrical potential, the second electrical potential being greater than the first electrical potential.

An apparatus comprises a diffuser, a connection tube section forming a tubular fluid passage, a first indicating element section that indicates a measurement related to a body fluid disposed between a distal end and the connection tube section, a second indicating element section that indicates that the first indicating element section is suitable for use, and a housing having a generally tubular body. The diffuser is at least partially disposed in the generally tubular body. A fluid chamber adapted to receive fluid is cooperatively defined by the housing and the diffuser. The first indicating element section is visibly disposed in a first section of the housing. The second indicating element section is disposed within the fluid chamber. A micro-needle collector to draw the fluid from a source to the distal end is attachable to the distal end.

Methods, apparatus, systems, and methods are described that relate to microneedle-assisted aptamer-based electrochemical sensing for label-free, continuous real-time monitoring of biomarkers in a biofluid. One example device for electrochemical monitoring of one or more analytes in a biofluid includes a substrate and at least two microneedles coupled to the substrate. Each microneedle in the at least two microneedles includes a protruded needle structure and an electrode probe structure. The electrode probe structure of a first microneedle in the at least two microneedles includes an aptamer sequence which is specific for a first analyte and the electrode probe structure of the first microneedle is operable as a working electrode for detection of the first analyte using a first electrochemical detection technique.

Transdermal microneedles continuous monitoring system is provided. The continuous system monitoring includes a substrate, a microneedle unit, a signal processing unit and a power supply unit. The microneedle unit at least comprises a first microneedle set used as a working electrode and a second microneedle set used as a reference electrode, the first and second microneedle sets arranging on the substrate. Each microneedle set comprises at least a microneedle. The first microneedle set comprises at least a sheet having a through hole on which a barbule forms at the edge. One of the sheets provides the through hole from which the barbules at the edge of the other sheets go through, and the barbules are disposed separately.

The disclosure relates to two methods to modify microneedles and needles to transform them as electrochemical sensors for ions and biomolecules. The methods focus on microneedles and needles made of any material through an external and internal modification methods to provide the function as electrodes: the working electrode, (pseudo)counter electrode and/or (pseudo)reference electrode depending on the electrochemical readout. With the external modification method, any solid microneedle and needle can be individually transformed in either of the said electrodes. With the internal modification method, any hollow microneedle and needle can be individually transformed in either of the electrodes. The working electrode, (pseudo)counter electrode and or (pseudo)reference electrode can be simultaneously integrated into the same hollow microneedle or needle by internal compartmentation. Two different biofluids can be simultaneously targeted by microneedles and needles of different sizes, structures and fabricated by one or both methods when integrated in the same skin patch.

Disclosed here are devices, systems, and methods for continuous monitoring of biomarkers using a wearable, non-intrusive microneedle sensor patch platform. In some aspects, a wearable, non-intrusive microneedle sensor device includes a microneedle sensor unit couplable to an electronics unit, where the microneedle sensor unit comprises a substrate, an array of spiked microneedle structures configured as electrochemical sensor electrodes, an array of base structures that encase a lower portion of spiked microneedle structures, and electrical interconnections that electrically couple the electrodes to the electronics unit for processing of detectable signals associated with one or multiple biomarkers in a biofluid.

A monitoring device for monitoring a hypocortiolism patient, the monitoring device comprising:a needle for penetrating a skin of the patient, andan analysis module fluidly connected with the needle, the analysis module comprising: o a first sensor, for measuring an inflammation level representative for the patient; and/or o a second sensor, for measuring a stress level representative for the patient; and wherein the monitoring device is configured to automatically trigger a notification in response to the first sensor measuring an inflammation level exceeding a first pre-defined threshold and/or in response to the second sensor measuring a stress level exceeding a second pre-defined threshold.

A puncture apparatus includes: a needle member having a tubular shape and comprising a flexible portion that is deformable; and a puncture assisting member that is movable or deformable in an axial direction of the needle member between: a restricting position in which the puncture assisting member is located outside the flexible portion of the needle member in a radial direction of the needle member, and thereby restricts deformation of the flexible portion, and a permissive position in which the puncture assisting member is not located outside the flexible portion in the radial direction, and thereby permits deformation of the flexible portion. The puncture assisting member is configured to move or deform from the restricting position to the permissive position in conjunction with an operation of inserting the flexible portion into a living body at a time of puncturing the living body with the needle member.

Provided are transdermal microneedle-based devices for sensing the presence and concentration of analytes such as electrolytes, biomarkers, drugs, and proteins in interstitial fluid. Also provided are methods and systems to transmit the data obtained by wired or wireless connection to a receiver and to relay the data to the user or a clinician.