Development of a Three-Microneedle Device for Hypodermic Drug Delivery and Clinical Application
ABSTRACT 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.
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ABSTRACT: We investigated the effectiveness of a newly developed device for the delivery of local anesthetics in the treatment of axillary osmidrosis and hyperhidrosis. We developed a device with three fine, stainless steel needles fabricated with a bevel angle facing outside ("three-microneedle device" [TMD]) to release a drug broadly and homogeneously into tissue in the horizontal plane. Use of this device could reduce the risk of complications when transcutaneous injections are undertaken. Sixteen Japanese patients were enrolled. The mean volume of lidocaine hydrochloride per unit area needed to elicit anesthesia when using a TMD was compared with that the volume required when using a conventional 27-gauge needle. The visual analog scale (VAS) score of needlestick pain and injection-associated pain was also compared. The mean volume of lidocaine hydrochloride per unit area to elicit anesthesia using the TMD was significantly lower than that the volume required when using the conventional 27-gauge needle. The VAS score of needlestick pain for the TMD was significantly lower than that the VAS score for the 27-gauge needle. These data suggest that the TMD could be useful for the delivery of local anesthetics in terms of clinical efficacy and avoidance of adverse effects.Patient Preference and Adherence 04/2015; 9:585-8. DOI:10.2147/PPA.S76540 · 1.49 Impact Factor