Provided herein are devices and methods for topically and controllably delivering cargo across or into biological tissues, particularly the skin. These devices permit delivery of cargo to deeper cell layers of a tissue. These devices include microstructure arrays comprising nanochannels. Also disclosed is a device comprising a one or more microstructure arrays encased in a frame.

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.

A microneedle array in accordance with one embodiment comprises at least a first microneedle and a second microneedle that are inclined with respect to a support face. A tip of the first microneedle points in a first direction, and a tip of the second microneedle points in a second direction different from the first direction. The first microneedle in contact with skin is stuck into the skin while being moved along a surface of the skin in the first direction. The second microneedle in contact with the skin is stuck into the skin while being moved along the surface of the skin in the second direction.

A manufacturing method for a micro-needle device includes following steps: a target tissue basic information obtaining step, a micro-needle template obtaining step, a micro-needle material adding step, a micro-needle semi-product obtaining step, and a micro-needle device obtaining step. The inner tissue distribution information is obtained by the application of optical coherence tomography. The micro-needle template is obtained according to the skin surface curvature information and the inner tissue distribution information. The micro-needle template has a plurality of areas and a plurality of mold holes. One or both of the diameter and the depth of the mold hole is determined by the inner tissue distribution information, and the curvature radius of the areas is determined by the skin surface curvature information. The manufacturing method for a micro-needle device is applicable to micro-needles with mixed configurations as well as micro-needles with syringe configurations.

The present invention provides a microneedle device comprising: a substrate; a microneedle disposed on the substrate; and a coating layer formed on the microneedle; wherein the coating layer comprises a physiologically active substance, arginine, and glycerin.

A device that may be placed on a biological barrier can be used to perforate the biological barrier for a variety of purposes such as cosmetic, scar treatment or for the delivery of active agents. A flexible substrate has a first side and a second opposing side and a plurality of micro-penetrator arrangements each comprising a head and a first and second projection, for penetrating a biological barrier, extending from the head. The first and second projection at least partially extend through the flexible substrate towards the first side. The head comprises an elongate arm for spacing apart the first and second projections. A force is applied to the second side causing flexing of the flexible substrate and pushing the projections into communication with a biological barrier.

A material with a nanotexture comprising structures extending from a substrate. The structures are modified by coating the nanotexture with a protective coating and partially removing the coating, exposing a portion of the structure for functionalization.

A microneedle device includes a substrate; a microneedle projecting from the substrate and configured to be inserted into skin; and a drug coating the microneedle. An aspect ratio of a maximum width of a base of the microneedle to a height of the microneedle is equal to or greater than 2.1.

A transdermal administration device including a first administration member including a first substrate and a first projection protruding from a first administration surface of the first substrate, and a second administration member including a second substrate and a second projection protruding from a second administration surface of the second substrate. The first substrate has an aperture, and the second substrate is positioned within the aperture when viewed in a direction perpendicular to the second administration surface.

A medical device for delivering a drug compound through a stratum corneum includes a support having an aperture, an array of microneedles extending outwardly from the support, a plurality of nanostructures associated with each microneedle, and a reservoir wherein the drug compound is retained. At least one microneedle contains a shaft extending from the support. The shaft includes a tip configured to penetrate the stratum corneum. The shaft defines a channel extending from the support to the tip. The channel is in at least partial alignment with the aperture. At least some of the microneedles of the array of microneedles each have a cross-sectional dimension of from about 1 micrometer to about 1 millimeter. At least some of the nanostructures have a cross-sectional dimension less than about 500 nanometers and greater than about 5 nanometers and an aspect ratio of from about 0.2 to about 5.