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Development of a Three-Microneedle Device for Hypodermic Drug Delivery and Clinical Application

Fukamizu, Hidekazu M.D., Ph.D.; Fujiwara, Masao M.D., Ph.D.; Kim, Taishi M.D.; Matsushita, Yuki M.D.; Tokura, Yoshiki M.D., Ph.D.

Plastic and Reconstructive Surgery: August 2012 - Volume 130 - Issue 2 - p 451–455
doi: 10.1097/PRS.0b013e3182589f56
Cosmetic: Ideas and Innovations
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Summary: There is a potential use for intradermic or hypodermic drug delivery in skin surgery or aesthetic surgery. Hypodermic delivery with the use of a noninvasive device can be a more useful, reliable, and effective administration route to obtain higher compliance. The authors developed a microneedle device composed of three fine needles (three-microneedle device). The tip of each needle was fabricated with a bevel angle to release a drug broadly into the tissue in a horizontal fashion. In this study, the authors investigated the usefulness of this newly developed three-microneedle device for hypodermic liquid injection, focusing on the optimum insertion depth and the diffusion of injected materials to the tissue. The authors also assessed the efficacy of and patient satisfaction with three-microneedle device injections of botulinum toxin type A for wrinkle reduction in patients with glabellar rhytides. The three-microneedle device yielded consistent results in hypodermal diffusion. On India ink diffusion test and ultrasonographic imaging, three-microneedle device injection showed a broad diffusion in horizontal extension, as compared with usual 31-gauge needle injection. The efficiency and satisfaction of the patients receiving botulinum toxin type A with the three-microneedle device were highly rated. Three-microneedle device delivery enables accurate and broad diffusion of injected substances, thus reducing the total dose and/or injection number of drugs.

CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

SUPPLEMENTAL DIGITAL CONTENT IS AVAILABLE IN THE TEXT.

Hamamatsu, Japan

From the Departments of Plastic and Reconstructive Surgery and Dermatology, Hamamatsu University School of Medicine.

Received for publication December 12, 2011; accepted February 21, 2012.

Disclosure: The authors have no financial interest in any of the products or devices mentioned in this article.

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Hidekazu Fukamizu, M.D., Ph.D.; Department of Plastic and Reconstructive Surgery, Hamamatsu University School of Medicine, 1-20-1 Handayama Higashi-ku, Hamamatsu 431-3192, Japan, fukamizu@hama-med.ac.jp

©2012American Society of Plastic Surgeons