The present invention provides for a method and apparatus for inserting and using, dermal interstitial sensors in, for example, an analyte monitoring system. The present invention permits the proper positioning of a cannula tip and/or sensor(s) within the reticular dermis.

A device for removing fluid from a body, the device comprising an array of microneedles and a housing; the array of microneedles being disposed within the housing and the housing defining a chamber. The microneedles are moveable between a disengaged position and an engaged position where, in use in the engaged position, the microneedles penetrate the surface of a body. The chamber is adapted to surround the surface of the body through which the microneedles penetrate when in the engaged position. The chamber is configured for connection to a vacuum device such that negative pressure can be applied to the chamber.

An integrated testing device is described, for example for testing bodily fluids. The device has a test component, 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 the test component.

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.

An apparatus includes a housing, a fluid reservoir, a flow control mechanism, and an actuator. The housing defines an inner volume and has an inlet port that can be fluidically coupled to a patient and an outlet port. The fluid reservoir is disposed in the inner volume to receive and isolate a first volume of a bodily-fluid. The flow control mechanism is rotatable in the housing from a first configuration, in which a first lumen places the inlet port is in fluid communication with the fluid reservoir, and a second configuration, in which a second lumen places the inlet port in fluid communication with the outlet port. The actuator is configured to create a negative pressure in the fluid reservoir and is configured to rotate the flow control mechanism from the first configuration to the second configuration after the first volume of bodily-fluid is received in the fluid reservoir.

A system for determining the presence of cell-free non-coding RNA (cfNCR) biomarkers in interstitial fluid includes a microfluidic device for non-invasively and passively accessing interstitial fluid from a patient. The microfluidic device is formed of a substrate containing multiple vertical micro channels therethrough, wherein at a first end of each of the multiple vertical micro channels a microheater is formed for controllably ablating a portion of dry dead skin cells to access the interstitial fluid; and wherein at a second end of each of the multiple vertical micro channels is a horizontal micro channel for receiving accessed interstitial fluid from a vertical micro channel and guiding the accessed interstitial fluid to a common collection port.

Multiplexed transdermal extraction and detection devices and systems for non-invasive monitoring of substances, such as glucose, are disclosed, as are methods of using these devices for substance monitoring in subjects.

The present disclosure is directed to enhanced sampling of bioanalytes from bodily fluids using wearable and/or insertable devices. In some embodiments, an apparatus (100, 500, 600) for sampling bioanalyte(s) in tissue (107, 507, 607) may include: a base (102, 502, 602) having conduit(s) adapted to receive fluid extracted from the tissue; microneedles (106, 306, 506, 606) fluidly coupled with the conduit(s) and adapted to be pierced into the tissue; a plurality of individually-controllable energy emitters (112, 114, 350, 612, 614); and logic (90) operably coupled with the plurality of individually-controllable energy-emitters. The logic may be adapted to operate a subset of the plurality of individually-controllable energy emitters to apply energy at a first subset of the microneedles to induce bioanalyte flow through tissue towards the first subset or a second subset of the microneedles, or through the first subset or a second subset of the microneedles.

An apparatus and method for examining an organism surface includes a pliable member including a contact layer, a plurality of channels, and a reaction layer, wherein the plurality of channels are disposed between the contact layer and the reaction layer; each of the channels having a size in the range of micrometers and formed of biocompatibility materials, and the contact layer including a plurality of spherical projections having a size in the range of micrometers and formed of biocompatible materials, and the reaction layer including examining molecules and a reaction unit.

The present invention provides for a method and apparatus for inserting and using, dermal interstitial sensors in, for example, an analyte monitoring system. The present invention permits the proper positioning of a cannula tip and/or sensor(s) within the reticular dermis.