Described is a microneedle device, preferably a controlled release device, for delivery of liothyronine (LT3 or salt thereof) to a patient with hypothyroidism and/or who is not pregnant. The microneedle device contains LT3 or salt thereof in an effective amount to maintain normal, stable levels, in the serum, of free and/or total T3. The microneedle device includes at least two components: multi-dimensional array of microneedle(s) and a substrate to which the base of the microneedle(s) are secured or integrated. The microneedles contain LT3 or salt thereof as well as a biodegradable and/or biodissolvable polymer, such as polyvinyl pyrrolidone for controlled release of LT3 or salt thereof. Also described are methods of making and using the microneedle device.

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.

A device and method for delivery of a bioactive agent across a dermal barrier of a subject. The device including a microneedle with a channel and a plurality of nanostructures and microstructures located on the microneedle. The nanostructures and microstructures are arranged in a fractal-like pattern. A reservoir is in fluid communication with the channel and contains a composition having a viscosity of greater than about 5 centipoise and comprising a bioactive agent. The method includes penetrating a stratum corneum of the subject with the microneedle and transporting a composition through the microneedle at a rate of greater than about 0.4 mg/hr/cm2 based upon the surface area of the microneedle.

A device and method for intravascular treatment of atherosclerotic plaque prior to balloon angioplasty which microperforates the plaque with small sharp spikes acting as serrations for forming cleavage lines or planes in the plaque. The spikes may also be used to transport medication into the plaque. The plaque preparation treatment enables subsequent angioplasty to be performed at low balloon pressures of about 4 atmospheres or less, reduces dissections, and avoids injury to the arterial wall. The subsequent angioplasty may be performed with a drug-eluting balloon (DEB) or drug-coated balloon (DCB). The pre-angioplasty perforation procedure enables more drug to be absorbed during DEB or DCB angioplasty, and makes the need for a stent less likely. Alternatively, any local incidence of plaque dissection after balloon angioplasty may be treated by applying a thin, ring-shaped tack at the dissection site only, rather than applying a stent over the overall plaque site.

A device and method for intravascular treatment of atherosclerotic plaque prior to balloon angioplasty which microperforates the plaque with small sharp spikes acting as serrations for forming cleavage lines or planes in the plaque. The spikes may also be used to transport medication into the plaque. The plaque preparation treatment enables subsequent angioplasty to be performed at low balloon pressures of about 4 atmospheres or less, reduces dissections, and avoids injury to the arterial wall. The subsequent angioplasty may be performed with a drug-eluting balloon (DEB) or drug-coated balloon (DCB). The pre-angioplasty perforation procedure enables more drug to be absorbed during DEB or DCB angioplasty, and makes the need for a stent less likely. Alternatively, any local incidence of plaque dissection after balloon angioplasty may be treated by applying a thin, ring-shaped tack at the dissection site only, rather than applying a stent over the overall plaque site.

Systems and methods are disclosed herein that generally involve CED devices with various features for reducing or preventing backflow. In some embodiments, CED devices include a tissue-receiving space disposed proximal to a distal fluid outlet. Tissue can be compressed into or pinched/pinned by the tissue-receiving space as the device is inserted into a target region of a patient, thereby forming a seal that reduces or prevents proximal backflow of fluid ejected from the outlet beyond the tissue-receiving space. In some embodiments, CED devices include a bullet-shaped nose proximal to a distal fluid outlet. The bullet-shaped nose forms a good seal with surrounding tissue and helps reduce or prevent backflow of infused fluid.

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 3D printed biocompatible drug delivery device is provided having a fluid delivery channel distinguishing three segments and a receiving chamber with an array of microneedles. The three segments of the delivery channel are stagnation zones before a drug is extruded and whereby an inverted funnel provides an increasing extrusion surface servicing the drug to the array of microneedles. The design of the device with its flow-related components circumvents the challenge of colloidal stability associated with multi-phase formulations leading to nozzle blockage. Qualitative screening cytotoxicity tests pre and post-extrusion through the drug delivery device using mammalian cells rule out cytotoxicity and outline equivalent viability to control treatments. The biocompatibility results suggest that the fluid delivery design, the photoresin selected as well as the fabrication and sterilization may be extended over a range of regenerative medicine and drug delivery applications.

A needle-shaped projection-including part (1), which is configured to inject a liquid to a target object, the needle-shaped projection-including part including: a plate (111) in which a vertically penetrating discharge hole (114) is formed; one or a plurality of fine needle-shaped projections (112) that project from one face of the plate (111); and a lip portion (113) that is formed at an outer edge portion of the one face of the plate (111), wherein in response to pushing out of the liquid from the discharge hole (114), the liquid spreads in a space defined by the target object, the lip portion (113), and the one face of the plate (111), and the liquid enters the target object through holes formed by the one or plurality of needle-shaped projections (112).

Devices and methods for delivering treatment fluids or particulates such as, stem cells, drugs, Botox and like, to an inner lining of a bladder for treatment of urinary tract disorders, including over-active bladder. A balloon delivery system can include an inflation balloon having a plurality of micro-needles configured to pierce and otherwise puncture an inner bladder wall so as to deliver the treatment fluid to bladder tissue. The treatment fluid can be directly injected into the bladder tissue using the micro needles. Alternatively, the micro needles can be fabricated of bioabsorbable or bioresorbable materials such that the micro needles can remain embedded within the bladder tissue to deliver the treatment fluid or particulate.