A reusable applicator for applying a microneedle patch to a skin of a subject which comprises a base for positioning onto the skin. The base comprises a skin-side end and a holder for holding the microneedle patch in position relative to the skin-side end. Two or more contact parts at the skin-side end can contact the skin. One or more are movable over the skin and away from the other contact 5 parts to stretch the skin at least during penetration of the skin by a microneedle of the patch. The applicator further comprises an interface for an actuator. The actuator actuates in operation a movement of the microneedle patch relative to the skin-side end to penetrate at least into the stratum corneum of the epidermis of the skin with the microneedle. A microneedle patch comprises a skin-adhesive surface for attaching the patch to the skin of a10 subject. The patch has one or more microneedles projecting from the skin-adhesive surface out of the patch. A stiffening body stiffens the patch in at least a parallel direction parallel to the skin-adhesive surface in a region of the skin-adhesive surface which includes the microneedle.

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.

Embodiments relate to an insertion device that includes: a plunger coupled with a lock collar. The insertion device houses contents including: a striker including self-locking striker snap arm(s) where the striker is kept from firing by a striker spring captured between the plunger and the striker when the insertion device is in a cocked position; a sensor assembly; and a needle carrier that holds a piercing member, the needle carrier captured between the striker and a needle carrier spring where a self-releasing snap(s) keeps the needle carrier cocked, where the plunger prevents the self-releasing snap(s) from repositioning and releasing the needle carrier. The striker fires the needle carrier such that the self-locking striker snap arm(s) are positioned to allow the striker to snap down. The needle carrier is then retracted when the user releases the plunger and the piercing member is encapsulated within the insertion device.

This present disclosure provides devices, systems, and methods for performing point-of-care analysis of a target analyte in a biological fluid via a binding assay. The present disclosure includes a cartridge for collecting the target analyte contained in a fluid sample and performing an assay. The cartridge includes an assay stack having a first separation layer, a second separation layer, and a detection membrane. The cartridge also includes a plurality of first complexes comprising a capture molecule and a magnetic bead and a plurality of second complexes comprising a detection molecule and a detection label. Further, the detection membrane includes a substrate that interacts with the detection label to elicit a quantifiable response in the presence of the target analyte. The quantifiable response corresponds to an amount of detection antibody present in the detection membrane, and the amount of detection antibody present corresponds to an amount of the target analyte present.

A biological fluid collection device that includes a housing and a cartridge that is removably receivable within a portion of the housing is disclosed. The biological fluid collection device of the present disclosure allows for collection of capillary blood from a finger stick and provides a closed system that reduces the exposure of a blood sample. In one embodiment, a cartridge of the present disclosure also provides fast mixing of a blood sample with a sample stabilizer. In another embodiment, a cartridge of the present disclosure provides automatic plasma separation of the blood sample. Advantageously, once the cartridge is filled with a sample aid removed from the housing, the cartridge can be used for a variety of important purposes.

Devices associated with on-body analyte sensor units are disclosed. These devices include any of packaging and/or loading systems, applicators and elements of the on-body sensor units themselves. Also, various approaches to connecting electrochemical analyte sensors to and/or within associated on-body analyte sensor units are disclosed. The connector approaches variously involve the use of unique sensor and ancillary element arrangements to facilitate assembly of separate electronics assemblies and sensor elements that are kept apart until the end user brings them together.

Embodiments relate to an insertion device that includes: a plunger coupled with a lock collar. The insertion device houses contents including: a striker including self-locking striker snap arm(s) where the striker is kept from firing by a striker spring captured between the plunger and the striker when the insertion device is in a cocked position; a sensor assembly; and a needle carrier that holds a piercing member, the needle carrier captured between the striker and a needle carrier spring where a self-releasing snap(s) keeps the needle carrier cocked, where the plunger prevents the self-releasing snap(s) from repositioning and releasing the needle carrier. The striker fires the needle carrier such that the self-locking striker snap arm(s) are positioned to allow the striker to snap down. The needle carrier is then retracted when the user releases the plunger and the piercing member is encapsulated within the insertion device.

A method of dispensing a therapeutic fluid from a line includes providing an inlet line connectable to an upstream fluid source. The inlet line is in downstream fluid communication with a pumping chamber. The pumping chamber has a pump outlet. The method also includes actuating a force application assembly so as to restrict retrograde flow of fluid through the inlet while pressurizing the pumping chamber to urge flow through the pump outlet. A corresponding system employs the method.

In one embodiment, a mixing device includes a sleeve that forms an inner space configured to receive a sample container, a housing associated with the sleeve, a mixing element contained within the housing that is configured to mix liquid contained within the sample container, and an activation element configured to activate the mixing element when the activation element is triggered.