A biological fluid sampling device for collecting a blood sample from a separate vascular access device and for ejecting a portion of the collected sample to a point-of-care testing device for analysis is provided. The biological fluid sampling device includes a body enclosing a reservoir. The reservoir has an internal volume sufficient to contain enough blood for use in a diagnostic test. The sampling device further includes: an access lumen extending from a distal end of the body for establishing fluid communication between a separate vascular access device and the reservoir; an outflow lumen also in fluid communication with the reservoir; and a removable vented cap attached to the outflow lumen including a gas permeable vent in gaseous communication between the reservoir and ambient air. In addition, several sample and transfer devices are provided for obtaining a sample from a subject and transferring the sample to a point-of-care testing device.

Provided is a transdermal microneedle array patch, including: a bottom cover; a top cover; a substrate disposed within the top cover; and a first probe and a second probe disposed between the bottom cover and the top cover and electrically connected the substrate. The first and second probes form an open circuit. While the bottom cover is combined with the top cover to form the transdermal microneedle array patch, the first and second probes form a closed circuit.

An arterial blood module (16) that is removably connectable to an arterial blood collection element (14) is disclosed. The arterial blood module includes a housing (30), a needle (32), a cap (34) removably securable over the needle, a mixing chamber (36), and a safety shield (38) engaged with a portion of the housing and transitionable from a first shield position in which a portion of the needle is exposed to a second shield position in which the needle is shielded by a portion of the safety shield. In one embodiment, the present disclosure includes an arterial blood collection system (10) that includes an arterial blood collection element (14) defining a collection chamber (20) and an arterial blood module (16) removably connectable to a portion of the arterial blood collection element.

An assembly having a patch (250) for a body-monitoring system, the patch having a main body (251) with an opening (252) of at least 2 mm diameter, the main body having a rigid zone (256) around the opening and a flexible zone (258) on either side of the rigid zone and preferably all around the rigid zone, and a capsule (220), the capsule being configured to be placed in the opening of the patch and to be rigidly attached to same. The capsule has microneedles (210) configured to be inserted in the skin in order to sample or analyse a bodily fluid of the wearer of a body-monitoring system when the system is positioned on a limb of a user, the rigid zone of the capsule enabling a transmission of the forces received by the patch to the capsule.

A liquid collection-injection needle assembly is provided including a needle cap that accommodates and protects a needle, and that is designed to be used for other purposes as well, so that the needle cap is effectively used, and the number of parts required for assembly is reduced. The assembly includes a needle holding member that holds a needle after needle has been inserted into holding member, and a needle cap that is configured to be connected detachably to a front part of needle holding member, and to protect the exposed portion of needle that is exposed from the needle holding member after needle has been inserted into needle holding member. In the state where needle cap communicates with needle holding member, an end portion of the needle cap is capable of communicating with a rear part of needle holding member.

Disclosed are methods and apparatus for determining analyte concentration in a sample such as bodily fluid. Systems and methods disclosed herein can also include a treatment dosing system to infuse or inject a treatment drug (e.g., insulin or glucose) and provide glycemic control. The dose of the treatment drug may be based on the concentration of th4e analyte or the average value for the concentration of the analyte and/or the rate of change of the value of the concentration of the analyte.

An arrangement for producing a sample of body fluid from a wound opening created in a skin surface at a sampling site includes: a housing, the housing comprising a first opening; a skin interface member disposed in the first opening, the skin interface member comprising an inner member having a second opening, and an outer member at least partially surrounding the inner member and attached to the first opening; and at least one skin-penetration member configured and arranged to project within the second opening. Arrangements having alternatively constructed skin interface members are also described.

In some examples, a diagnostic device includes a reusable part to receive a container of a fluid, the reusable part reusable for a plurality of diagnostic tests. The diagnostic device further includes a disposable part detachably attached to the reusable part and comprising a sample collector to collect a target sample of a living being. The diagnostic device further includes a tester comprising a fluid channel to transport the fluid to combine the fluid and the target sample to form a fluid combination, and to use the fluid combination to diagnose a condition of the target sample.

A device (1) for obtaining a biological sample that includes a blood collection device (10) and a vibration device (80) removably attachable to the blood collection device that provides pain relief is disclosed. The vibration device of the present disclosure provides pain relief to a patient by vibrating the blood collection device. The vibration device can be attached to the blood collection device before it is placed onto a finger to provide pain relief during the finger lancing as well as to aid blood flow from the finger into a collection container during the collection process.

The present invention relates to a body attachment unit for continuous glucose monitoring. The present invention provides a body attachment unit for continuous glucose monitoring, wherein: the body attachment unit is manufactured in the state in which the body attachment unit is assembled in an applicator, and thus separate additional work is minimized and the body attachment unit can be attached to the body by simply operating the applicator; in particular, a wireless communication chip is disposed in the body attachment unit so as to communicate with an external terminal, and thus simple and convenient use can be achieved without any additional work for connection of a separate transmitter and maintenance and management can also be easily performed; and the monitoring operation is started by a user's manipulation after the body attachment unit is attached to the body, and thus the user can adjust the operation start time to an appropriate point as necessary and the operation can be started in a stabilized state so as to enable more accurate glucose monitoring.