Systems and methods are provided for determining levels of an analyte in a biological fluid sample. A transdermal sampling and analysis device may include a substrate, at least one disruptor mounted on the substrate, a reservoir configured to collect and contain a biological fluid sample; a sensing element comprising at least two sensing electrodes, and at least one layer of a cofactor covering the sensing element in which the cofactor catalyzes a reaction to determine levels of an analyte in the biological fluid sample. The at least one disruptor of the transdermal sampling and analysis device may generate a localized heat capable of altering permeability characteristics of a stratum corneum layer of skin of an organism. The surface of at least one of the sensing electrodes of the transdermal sampling and analysis device may be coated with a sensing layer in which an enzyme immobilized within a hydrogel.

Bodily fluid sample collection systems, devices, and method are provided. The device may comprise a first portion comprising at least a sample collection channel configured to draw the fluid sample into the sample collection channel via a first type of motive force. The sample collection device may include a second portion comprising a sample container for receiving the bodily fluid sample collected in the sample collection channel, the sample container operably engagable to be in fluid communication with the collection channel, whereupon when fluid communication is established, the container provides a second motive force different from the first motive force to move a majority of the bodily fluid sample from the channel into the container.

Needle-less extraction of a biospecimen from tissue having a number of tissue layers including an epidermis layer includes creating a first port through a target surface and into an underlying one of the tissue layers, creating a second port through the target surface and into the underlying one of tissue layers, providing an injectate through the first port to the underlying one of the tissue layers underlying the epidermis layer, and extracting at least a portion of the injectate and the biospecimen from the underlying one of the layers through the second port.

Systems and methods for delivering to and/or receiving fluids or other materials, such as blood or interstitial fluid, from subjects, e.g., from the skin. Beading disruptors and/or capillaries may be used for facilitating the transport of fluids from a subject into a device. Beading disruptors may disrupt the pooling of bodily fluids such as blood on the surface of the skin and help influence flow in a desired way. A capillary may conduct flow of fluid in the device, e.g., to an inlet of a channel or other flow path that leads to a storage chamber. A vacuum (reduced pressure relative to ambient) may be used to receive fluid into the device, e.g., by using relatively low pressure to draw fluid into the inlet of a channel leading to a storage chamber. The vacuum source may be part of the device and have a volume that is larger than a recess of the fluid transporter that receives fluid from a surface.

Disclosed are a support body, a body fluid collection set, and a body fluid collection method that can easily support a body fluid collection sheet even by a non-physician. The support body 1 includes a first sheet 10 having an adhesive surface 12 for adhering the body fluid collection sheet 30, and a second sheet 20 adhered to the first sheet 10. The adhesive surface 12 of the first sheet 10 is adhered to the body fluid collection sheet 30 so that the first sheet 10 is separated from the skin 40 and the body fluid collection sheet 30 is peeled off from the skin 40. Thereafter, the second sheet 20 is superposed on the adhesive surface 12, and the body fluid collection sheet 30 is supported on the support body 1.

The present invention generally relates to receiving bodily fluid through a device opening. In one aspect, the device includes a flow activator arranged to cause fluid to be released from a subject. A deployment actuator may actuate the flow activator in a deployment direction, which may in turn cause fluid release from a subject. The flow activator may also be moved in a retraction direction by a retraction actuator. In one aspect, the device may include a vacuum source that may help facilitate fluid flow into the opening of the device and/or may help facilitate fluid flow from the opening to a storage chamber. In one aspect, a device actuator may enable fluid communication between the opening and the vacuum source and the flow activator may be actuated after the enablement of fluid communication.

Methods and devices of collecting ISF from skin. The methods may include inserting an array of microneedles into a patients skin to form apertures in the patients skin, facilitating ISF mobilization within the skin, and collecting ISF that flows from the apertures. The devices may include an array of microneedles extending from a backing structure. The devices also may include a collection matrix for collecting ISF and/or means for facilitating ISF mobilization.

The present invention relates to a method and corresponding apparatus for just in time mixing of a solid or powdered formulation and its subsequent delivery to a biological body. In some embodiments, a powdered formulation is maintained in a first chamber of a plurality of chambers. A plurality of electromagnetic actuators are in communication with the plurality of chambers. The actuators, when activated, generate a pressure within at least the first chamber. The pressure results in mixing of the powdered formulation and a diluent in time for delivering into the biological body.

Microfluidic devices are provided for continuous sampling of biological fluid for extended periods of time, e.g. for periods of time up to and including 10 days. The microfluidic devices can be made from porous hydrophilic substrate, e.g. hydrophilic paper substrates. The devices can include a collection pad, an evaporative pump, and a channel connecting the collection pad and the evaporative pump. Hydrogels at the collection pad can promote collection of sweat or other biological fluids from a subject, which in some aspects is assisted by the use of one or more microneedles on the substrate. An evaporative pump can provide for long periods of sampling by providing continual pumping, e.g. through the use of an evaporation pad where sampled fluid can evaporate.

A sampling device for collecting and dispensing a sample is disclosed, the sampling device including a sample collector having an absorbent portion configured to collect a sample and a receiving section configured to receive the sample collector after the collection of the sample. In one embodiment, the receiving section includes a dropper, the sample collector configured to be secured to the dropper, the dropper defining an internal chamber in which the absorbent portion of the sample collector is received when the sample collector is secured to the dropper; and a base releasably engaged with the dropper and at least partially housing the dropper, wherein the dropper is configured to be released from the base to allow dispensing of the sample from the dropper. In one embodiment, the absorbent portion interferes with a surface of an internal chamber of the receiving section. In one embodiment, a length adapter for the sample collector is employed and, in another embodiment, a desiccant housing is employed.