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.

Described here are meters and methods for sampling, transporting, and/or analyzing a fluid sample. The meters may include a meter housing and a cartridge. In some instances, the meter may include a tower which may engage one or more portions of a cartridge. The meter housing may include an imaging system, which may or may not be included in the tower. The cartridge may include one or more sampling arrangements, which may be configured to collect a fluid sample from a sampling site. A sampling arrangement may include a skin-penetration member, a hub, and a quantification member.

Microneedle (100, 200, 300, 720) comprising an elongated body (110, 210, 310) extending along a longitudinal axis from a top end to a bottom end on a substrate (300, 710), where the elongated body comprises an upper portion (120, 220, 320) and a lower portion (130, 230, 330). The lower portion (130, 230, 330) comprises an internal capillary bore hole (260, 730) extending into the substrate (300, 710). The upper portion (120, 220, 320) of the elongated body (110, 210, 310) has a semi-enclosed internal void space (140, 240) formed by at least three body sides whereof two body sides join at a sharp edge and a third body side is provided with an opening slit (150, 250, 350) extending from the lower portion (130, 230, 330) of the elongated body (110, 210, 310) to the upper end of the third body side. The top end of the elongated body (110, 210, 310) is configured as a bevel to create a sharp tip at the top of said edge, said bevel extending to the third body side. The semi-enclosed internal void space (140, 240) of the upper portion opening to the internal capillary bore hole of the bottom end of the elongated body (110, 210, 310), and the bottom end of the elongated body is connected to the substrate (300, 710).

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.

The present invention relates to a whole blood and fingertip blood testing device, including a blood collection structure and a testing chamber connected to and in fluid communication with the blood collection structure. The blood collection structure includes a collection rod, a capillary channel is arranged inside the collection rod, the bottom end of the capillary channel is located at the tail end of the collection rod, and the top end of the capillary channel is located in the middle of the capillary channel; and the collection rod is provided with a communicating hole connected to and communicated with the top end of the capillary channel. Moreover, the present invention also provides a method for collecting and testing a blood sample by using the testing device. Through the integrated structure of the blood collection structure, the testing chamber and the buffer chamber, the whole blood and fingertip blood testing device and method achieve functions of collecting, slowly releasing and testing the blood sample. The operation is easy, which reduces the difficulty of use by the operator. The number of times and time that the operator contacts the sample are effectively reduced, and the infectious possibility of the operator is reduced, so that the testing device is suitable for HIV testing, novel coronavirus testing, etc. The testing device and method have low requirements on the collected amount of the sample, and the collected amount is optimized from the milliliter level to the microliter level.

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 method of assembling a lancet housing assembly comprising multiple lancets for use in a portable handheld medical diagnostic device for sampling bodily fluids from a skin site of a patient is disclosed. The method includes forming a plurality of lancet structures in a lancet sheet. The lancet sheet has a removable ledge for releasing the lancet structures. The removable ledge of the lancet sheet is flexed for releasing the lancet structures from the removable ledge.

Described here are meters and methods for sampling, transporting, and/or analyzing a fluid sample. The meters may include a meter housing and a cartridge. In some instances, the meter may include a tower which may engage one or more portions of a cartridge. The meter housing may include an imaging system, which may or may not be included in the tower. The cartridge may include one or more sampling arrangements, which may be configured to collect a fluid sample from a sampling site. A sampling arrangement may include a skin-penetration member, a hub, and a quantification member.

The present invention generally relates to systems and methods for receiving blood (or other bodily fluids) from a subject, e.g., from or beneath the skin of a subject. In some cases, the blood (or other bodily fluids) may be deposited on a membrane or other substrate. For example, blood may be absorbed in a substrate, and dried in some cases to produce a dried blood spot. In one aspect, the present invention is generally directed to devices and methods for receiving blood from a subject, e.g., from the skin, using devices including a substance transfer component (which may contain, for example, one or more microneedles), and directing the blood on a substrate, e.g., for absorbing blood. The substrate, in some embodiments, may comprise filter paper or cotton-based paper. After absorption of some blood onto the substrate, the substrate may be removed from the device and shipped or analyzed. In some cases, the device itself may be shipped or analyzed. For example, in some embodiments, a portion of the device may be sealed such that the substrate is contained within an airtight portion of the device, optionally containing desiccant. Other aspects are generally directed at other devices for receiving blood (or other bodily fluids), kits involving such devices, methods of making such devices, methods of using such devices, and the like.