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.

In one embodiment, an IDDC system utilizes an intelligent therapeutic agent delivery system comprised of one, but more likely an array of cells containing therapeutic agent(s) and/or diagnostic agents(s); an integrated bio-sensing system designed to sample and analyze biological materials using multiple sensors that include both hardware and software components. The software component involves biomedical signal processing to analyze complex liquid mixtures and a microcontroller(s) acts as interface to the biosensors, to the therapeutic delivery elements, and to a communications system(s) for the purpose of controlling the amount of therapeutic agent to deliver and also to provide information in a useful form to interested parties on the progress of therapy and compliance thereto. The synergistic effect of combining the above describe elements is expected to dramatically improve patient compliance with prescribed therapy, quality and timeliness of care provided by physicians, and at the same time reduce the cost of providing effective healthcare to IDDC system users, thereby improving profitability for Managed Care organizations and pharmaceutical companies utilizing the system.

Disclosed is a microneedle array. The microneedle array includes a substrate, a plurality of needle openings provided in the substrate, and a plurality of needle units disposed around respective needle openings and each having a plurality of microneedles circumferentially arranged at regular intervals around respective needle opening to protrude from the substrate so as to be inserted into the skin.

Disclosed are composite microneedles arrays including microneedles and a film overlaying the microneedles. The film includes a plurality of nano-sized structures fabricated thereon. Devices may be utilized for interacting with a component of the dermal connective tissue. A random or non-random pattern of structures may be fabricated such as a complex pattern including structures of differing sizes and/or shapes. Devices may be beneficially utilized for delivery of an agent to a cell or tissue. Devices may be utilized to directly or indirectly alter cell behavior through the interaction of a fabricated nanotopography with the plasma membrane of a cell and/or with an extracellular matrix component.

The present disclosure describes microtips, MicroArrays, MicroArray Patches comprising MicroArrays, delivery devices, and methods of manufacturing and methods of using same. In some embodiments, a substance-loaded MicroArray is prepared by photochemically etching MicroArray outlines in a substrate sheet, the MicroArrays comprising a plurality of microtips, configuring reservoirs in each microtip such as by photochemical half etching, filling each reservoir with a substance to be delivered, and then bending each of the microtips out of planarity such that each microtip comprises a substance-loaded projection disposed an angle relative to the generally planar substrate sheet.

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.

The present invention concerns delivery of agents to the skin. Methods for delivering agents such as bioactive agents are contemplated by the present invention. Specifically, methods for delivering an agent to one or more areas of the epidermis and, thereby, to the lymphatic system are described.

Provided are a micro-needle patch and a manufacturing method thereof. The micro-needle patch includes: a support on one surface of which grooves are formed; a gel membrane for delivery of a transmitter to be transferred in which the grooves are filled with a mixture of the transmitter with a biodradable resin, the mixture being in a gel phase; a plurality of micro-needles projected on the other surface of the support and for penetrating the skin; a first protective film that covers the gel membrane and is adhered on the support; and a second protective film that covers the plurality of micro-needles and is adhered on the other surface, wherein passages are formed by being penetrated from the support to each of the plurality of micro-needles or formed by penetrating the support between the plurality of micro-needles, so that the transmitter of the gel membrane is transferred to the skin.

A device and method for delivering a high viscosity composition is described. The composition includes a bioactive agent for delivery to a subject in need thereof. The method delivers the bioactive agent at a high bioavailability and with little loss of agent to the natural defense mechanisms of the body. The device includes one or more microneedles with structures fabricated on a surface of the microneedles to form a nanotopography. A random or non-random pattern of structures may be fabricated such as a complex pattern including structures of differing sizes and/or shapes.

A uniformity control membrane can be securely engaged against an upstream side of a microneedle array and configured so that resistance to flow through the uniformity control membrane is substantially greater than the resistance to flow through the microneedle array. These differences in flow resistance can facilitate uniform administration of a liquid formulation into the patient's skin across a broad area and at a relatively low pressure, such as by way of capillary action. The administration of the liquid formulation into the patient's skin across the broad area can result from the liquid formulation being administered by way of at least a majority of the microneedles of the microneedle array.