A device includes a plurality of skin penetrating devices for delivering or withdrawing a substance through the skin of a patient. The device has a support formed with a top and bottom end and a plurality of channels extending axially through the support. A plurality of the skin penetrating members is positioned in the channels with a tip extending from the bottom end of the support. A coupling member is attached to the support for coupling with a fluid supply and directing the fluid to the skin penetrating members. The skin penetrating members have a length of about 100 microns to about 2000 microns and are about 30 to 50 gauge.

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 generally relates to systems and methods for delivering and/or receiving a substance or substances such as blood, from subjects, e.g., from the skin and/or from beneath the skin. In one aspect, the present invention is generally directed to devices and methods for receiving or extracting blood from a subject, e.g., from the skin and/or from beneath the skin, using devices containing a fluid transporter (for example, one or more microneedles), and a storage chamber having an internal pressure less than atmospheric pressure prior to receiving blood. In some cases, the device may be self-contained, and in certain instances, the device can be applied to the skin, and activated to receive blood from the subject. The device, or a portion thereof, may then be processed to determine the blood and/or an analyte within the blood, alone or with an external apparatus. For example, blood may be received from the device, and/or the device may contain sensors or agents able to determine the blood and/or an analyte suspected of being contained in the blood. In another aspect, the present invention is generally directed to arrangements of skin insertion objects such as microneedles and methods of forming and arranging skin insertion objects. Other aspects of the present invention are directed at other devices for receiving blood (or other bodily fluids, e.g., interstitial fluid), kits involving such devices, methods of making such devices, methods of using such devices, and the like.

A microsensor and method of manufacture for a microsensor, comprising an array of filaments, wherein each filament of the array of filaments comprises a substrate and a conductive layer coupled to the substrate and configured to facilitate analyte detection. Each filament of the array of filaments can further comprise an insulating layer configured to isolate regions defined by the conductive layer for analyte detection, a sensing layer coupled to the conductive layer, configured to enable transduction of an ionic concentration to an electronic voltage, and a selective coating coupled to the sensing layer, configured to facilitate detection of specific target analytes/ions. The microsensor facilitates detection of at least one analyte present in a body fluid of a user interfacing with the microsensor.

A microsensor and method of manufacture for a microsensor, comprising an array of filaments, wherein each filament of the array of filaments comprises a substrate and a conductive layer coupled to the substrate and configured to facilitate analyte detection. Each filament of the array of filaments can further comprise an insulating layer configured to isolate regions defined by the conductive layer for analyte detection, a sensing layer coupled to the conductive layer, configured to enable transduction, and a selective coating coupled to the sensing layer, configured to facilitate detection of specific target analytes/ions. The microsensor facilitates detection of at least one analyte present in a body fluid of a user interfacing with the microsensor.

The present invention is directed to devices including one or more hollow needles and a transducing wire disposed within at least one needle. In particular instances, arrays of such needles can be employed. Methods for fabricating and using such devices are also disclosed herein.

A microneedle and a chip are disclosed for extraction fluids. The microneedle is provided on a substrate and comprises an elongated body extending from a distal end with a bevel to a proximal end on the substrate along a longitudinal axis. The elongated body comprises a capillary bore extending in a longitudinal direction thereof and defines a fluid path. The proximal end is integrally connected with the substrate and the capillary bore is in fluid communication with a fluid channel of the substrate. The cross-sectional area of the capillary bore in the distal end is larger than the cross-sectional area of the capillary bore in the proximal end.

A gelatin-based (e.g., gelatin methacryloyl (GelMA)) patch is disclosed with an array of microneedles (MNs) for minimally invasive sampling of bodily fluids such as interstitial fluid (ISF). The properties of the patch can be tuned by altering the concentration of the GelMA prepolymer and the crosslinking time. The GelMA-based MN patch demonstrated efficient extraction of ISF. Furthermore, in experimental testing, the patch efficiently and quantitatively detects glucose and vancomycin in ISF in an in vivo study. This minimally invasive approach of extracting ISF with a GelMA microneedle enables to detection and analysis of target molecules from patients. The target molecules captured in the patch may be released and analyzed to detect the presence of and/or concentration of target molecules. In other embodiments, the patch itself may be analyzed directly to detect the presence of and/or concentration of target molecules.

A microneedle and a chip are disclosed for extraction of fluids. The microneedle (101) provided on a substrate (102), comprises an elongated body (503) extending from a distal end (504) with a bevel (505) to a proximal end (506) on the substrate along a longitudinal axis; the elongated body comprises a capillary bore (507) extending in a longitudinal direction thereof and defines a fluid path (508); the proximal end is integrally connected with the substrate and the capillary bore is in fluid communication with a fluid channel (309) of the substrate. The cross-sectional area of the capillary bore in the distal end is larger than the cross-sectional area of the capillary bore in the proximal end.