Fabrication, packaging, and application of micromachined hollow polymer needle arrays

Abstract

Micromachined needles have been shown to successfully transport biological molecules into the body with minimal invasiveness and pain, following the insertion of needles into the skin. The aim of this research is to demonstrate that micromachined hollow polymer needle arrays fabricated using UV lithography into micromolds, a potential batch-manufacturable process, can exhibit comparable insertion and injection performance to conventional hypodermic needles for drug delivery into skin. A dual-exposure-and-single-development process flow is proposed for the above-mentioned UV lithography into micromolds approach to construct a pyramidal-tip hollow microneedle array with an integral baseplate and fluidic manifold. The developed process ultimately resulted in the ability to fabricate a 10×10 array of hollow SU-8 microneedles measuring 825 μm in height, 400 μm in width, and possessing a lumen of 120 μm in diameter. The tip diameter of the microneedles ranges from 15 μm to 25 μm. The insertion force of single needles characterized using excised porcine skin as a substrate is 2.4±1.2 N. Nevertheless, the high insertion force of 2.4 N per needle may cause a significant concern when a large number of needles are required to insert into skin for drug delivery. Conventional hypodermic needles have two key structural characteristics: a sharp beveled tip and a large side-terminated lumen. Integration of these two key characteristics of hypodermic needles into microneedle design can potentially enhance microneedle performance. To reduce the insertion force and to incorporate the two key characteristics of hypodermic needles into the design of microneedles, a new needle tip design, namely the hypodermic-needle-like design, is presented. A 6×6 array of hypodermic-needle-like microneedles of 1 mm in height, approximate 350 μm in width, and with a lumen of 150 μm in diameter is demonstrated with successful insertion of the needle array into skin and an 85% lumen openness yield. The insertion force is significantly reduced by an order of magnitude with the new needle tip design and is 0.275±0.113 N per needle, comparable to that of hypodermic needles, i.e., 0.284±0.059 N. The hypodermic-needle-like microneedles exhibit a margin of safety of 180 for successful needle insertion into skin prior to needle fracture. A successful manual fluid injection into skin using single microneedle is demonstrated. The micromachined hypodermic-needle-like polymer needle arrays presented in this dissertation are fabricated using UV lithography into micromolds, a potentially batch-manufacturable process, and exhibit comparable insertion performance to conventional hypodermic needles. Injection capability into skin is also demonstrated with a hypodermic-needle-like microneedle, illustrating the utility of these devices.