The present disclosure relates generally to devices, systems, and methods for diagnosis and treatment via laser-treated skin and, more particularly, to devices, systems, and methods for inducing leakage or rupture of one or more blood vessels comprising the dermis for various diagnostic and therapeutic applications. Other aspects of the present disclosure can include methods for detecting one or more target analytes in a dermis of a subject, methods for facilitating skin-to-blood delivery of agent in a subject, and methods for collecting a fluid sample from the dermis of a subject.

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.

Methods and systems for collecting and analyzing blood are provided. The methods and systems generally operate by collecting a blood sample on a portion of a lancet and subjecting the blood sample to optical spectroscopy.

An apparatus for insertion of a medical device in the skin of a subject is provided, as well as methods of inserting medical devices. Embodiments include removing a substantially cylindrical cap from an inserter to expose a substantially cylindrical sleeve, removing a cover from a substantially cylindrical container holding sensor components, and fitting the sensor components into the inserter.

A device which, in a shallow region including the epidermal layer or the dermal layer, can administer a target even in extremely small amounts. This includes a puncture needle which, in a flat puncture unit for puncturing the shallow region, has a groove and a through-hole which constitute a recess that extends through part of or the entire thickness of the puncture unit; and a casing which houses the puncture needle so as to allow the puncture needle to advance. By part or all of a flow agent containing the drug being arranged in the groove and the through-hole, the drug is positioned with respect to the puncture unit. The device is designed such that a flow agent in the amount of 10-1000 nL is dosed in the shallow region per puncture.

A fluid sampling device and a method is provided for collecting body fluid samples such as blood without the intervention of medically trained personnel. The body fluid sampling device having a sample containment chamber made of a material having a thermal inertia permitting the maintenance of sample temperature over a known period of time. Optionally an isolating cover or sleeve may slide in place by a mechanism triggered by thermal contraction of an element after the device has reached a sufficiently low temperature in a patients refrigerator. Associated methods are provided to ensure hermetic transport of the collected body fluid sample to an analysis lab. Also disclosed is a device and app combination for drug or vaccine injection, the app including means to allow for verification of the patient's ID and/or the particular device used. The device my be equipped with geo-localization and long-range communication capabilities.

A body fluid sensing device with a body fluid capture structure and a body fluid measurement sensor positioned in the body fluid capture structure. A capacitance sensor is coupled to the body fluid measurement sensor. The capacitance sensor is used to assist in the positioning of a body part relative to the body fluid capture structure.

Disclosed herein are devices, apparatus, systems, methods and kits for collecting and storing a fluid sample from a subject. A device for collecting the fluid sample can include a housing comprising a recess having an opening, a vacuum chamber in the housing and in fluidic communication with the recess, and one or more piercing elements that are extendable through the opening to penetrate skin of the subject. The vacuum chamber can be configured for having a vacuum that draws the skin into the recess. The recess can be configured having a size or shape that enables an increased volume of the fluid sample to be accumulated in the skin drawn into the recess.

Methods and apparatus are provided for manufacturing an analyte detecting device. In one embodiment, the apparatus comprises a housing; a penetrating member driver; a cartridge containing a plurality of penetrating members; a display on the cartridge; a linear slider on the housing, the slider coupled to a rod; and the rod moving with the slider, the rod having at least one roller. The device uses the linear motion of the slider to rotate the cartridge, punch open a new cavity and load a new penetrating member.