A dermal patch for collecting a physiological sample includes a housing with a collection chamber, a sample channel and a pin within a receptacle of the housing. The sample channel is configured to direct a physiological sample drawn from a subject to the collection chamber. The pin is removably positioned within the receptacle and is configured to move from an undeployed position to a deployed position. The pin is configured to seal the receptacle when in the undeployed position and is further configured to facilitate generation of negative pressure in the sample channel when the pin is moved from the undeployed to the deployed position.

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.

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.

A biological fluid separation device that is adapted to receive a multi-component blood sample is disclosed. After collecting the blood sample, the biological fluid separation device is able to separate a plasma portion from a cellular portion. After separation, the biological fluid separation device is able to transfer the plasma portion of the blood sample to a point-of-care testing device. The biological fluid separation device of the present disclosure also provides a closed separation and transfer system that reduces the exposure of a blood sample and provides fast mixing of a blood sample with a sample stabilizer. The biological fluid separation device is engageable with a blood testing device for closed transfer of a portion of the plasma portion from the biological fluid separation device to the blood testing device. The blood testing device is adapted to receive the plasma portion to analyze the blood sample and obtain test results.

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.

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.

The invention relates to a lancet for performing an incision. The lancet has a blade for providing an incision and a trigger housed in a housing. The trigger has a first trigger arm, a second trigger arm and a flexible member connected to the second trigger arm. A resilient member may be disposed within the housing in a pre-cutting state in which it stores energy and arranged to exert a force for moving the second trigger arm and the blade from a first stowed position through a cutting position and to a second stowed position.

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.

Sheathed cutting device. An exemplary device for discreetly piercing a skin of a patient can comprise a body having a proximal end and a distal end, a cutting member attached to a plunger, the cutting member and the plunger positioned at least partially within the body, and a biasing member configured to bias the cutting member to an initial position whereby the cutting member is positioned fully within the body, wherein the plunger is slidable into the proximal end of the body, causing the cutting member to extend from the distal end of the body.

The disclosure discloses a single-handed operable infant heel blood sampling device and its safety mechanism, including a push-pull rod and an actuating rod partially extending outside the blood sampler housing; the actuating rod has a second hook portion that can engage with the first hook portion; to perform blood sampling, push down the push-pull rod to disengage the buckle portion from the housing, causing the first hook portion to engage with the second hook portion on the first end of the actuating rod; then pull up the push-pull rod to pull the actuating rod, and the actuating rod thus releases a pre-compressed spring set inside the blood sampler housing, allowing the blade originally positioned in a first position inside the housing to slide out from a cutting port and then be retracted into a second position inside the housing.