The present invention generally relates to collecting, determining and/or transmitting information associated with the process of receiving bodily fluid through a device opening and/or delivering substances to a subject. In one aspect, the device includes an information collecting portion and a fluid receiving portion. In another aspect, the two portions are constructed and designed to attach to one another. In one embodiment, actuation of one of the portions causes the other portion to actuate. Methods of time keeping and information transmission are also discussed.

An interstitial fluid removal device including a first needle, a second needle, a fluid injector and an interstitial fluid extractor. The first needle is configured for insertion in a tissue of a multicellular organism to provide a fluid inlet channel. The second needle is configured for insertion in a tissue of a multicellular organism to provide an interstitial fluid outlet channel. The fluid injector is arranged in fluid communication with both a fluid source and the first needle and configured to inject a fluid in the tissue of the multicellular organism. The fluid extractor is arranged in fluid communication with the second needle and configured to extract interstitial fluid from the tissue of the multicellular organism. The fluid injector and the fluid extractor are independently and/or simultaneously operable with respect to each other.

A universal single-handed device for self-collection of a biological sample is described herein. The single-handed device may comprise a sheath comprising a distal end for insertion into a portion of a user's body, a shaft at least partially within the sheath, having a collection head for collecting the biological sample positioned at the distal end thereof, and an actuator coupled to the shaft to transition the distal end between an open configuration and a closed configuration. The collection head is covered by the distal end in the closed configuration and is exposed when the distal end is in the open configuration.

Methods, systems, and apparatus, including biological fluid monitoring systems comprising a microneedle layer; at least one electromagnet assembly; and at least two liquid chambers coupled via a microfluidic layer, wherein the microneedle layer comprises a plurality of microneedles configured to extract interstitial fluid (ISF) from a patient in to one of the at least two liquid chambers, and wherein the at least one electromagnet assembly is configured to a move a test sample of the extracted ISF through the at least two liquid chambers to conduct a test cycle.

Devices and methods for withdrawing bodily fluid from a patient are disclosed herein. A handheld device configured in accordance with the present technology can include a housing having an opening, a skin-piercing assembly located at least partially within the housing, and an actuator movable relative to the housing along a deployment direction. The skin-piercing assembly can include a skin-piercing feature and a biasing member. The biasing member can be coupled to the skin-piercing feature to bias the skin-piercing feature along the deployment direction. Movement of the actuator along the deployment direction to a predetermined position can increase a load on the biasing member to at least a partially loaded state. Movement of the actuator along the deployment direction beyond the predetermined position can release the load on the biasing member so that the biasing member actively drives the skin-piercing feature along the deployment direction.

Disclosed herein is an intradermal needle device including a rigid base; a needle rigidly affixed to the rigid base, the needle including a hollow shaft extending from the rigid base along an axis to a tip of the needle; a cap formed from a deformable material affixed to the rigid base and extending along the axis, the cap comprising a cushion portion surrounding a portion of the hollow shaft, the cushion portion having a convex-shaped surface facing away from the rigid base, wherein the tip of the needle extends beyond the convex surface by a non-zero distance of 1.5 mm or less and wherein when the intradermal needle device can be pressed with the needle tip against skin of a living body, the tip pierces the skin to a depth of 1.5 mm or less and the convex-shaped surface of the cushion portion deforms against the skin surrounding the needle.

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.

The present invention relates to novel surgical drains and associated methods and systems. Specifically, the present invention includes a surgical drain with at least two ports. A first port drains lymphatic fluid from a subject for collection and analysis. The second port functions to introduce a therapeutic into the subject.

An integrated testing device and fluid module are disclosed, as well as a method of manufacture. Fluid module contains a reservoir containing a test fluid, and a control vessel. The reservoir discharges test fluid into the control vessel, which discharges the test fluid in a controlled way to a test component.

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.