Beveled microneedles with channel for transdermal injection and sampling, fabricated with minimal steps and standard MEMS technology

Microneedles hold the potential for enabling shallow skin penetration applications where biomarkers are extracted from the interstitial fluid (ISF) and drugs are injected in a painless and effective manner. To this purpose, needles must have an inner channel. Channeled needles were demonstrated using custom silicon microtechnology, having several needle tip geometries. Nevertheless, all the proposed fabrication sequences are not compatible with mass production based on mature, standard microfabrication techniques. Furthermore, ISF extraction was also demonstrated with channeled needles but under poorly controlled conditions and over long periods of time, the latter being impractical for medical use. A range of factors may impede or slow ISF extraction that require controlled experiments. In this work we address the above tasks in terms of microfabrication sequence design, tip geometry design and experimental validation under controlled conditions. We report the development and fabrication of a silicon channeled microneedle array using conventional, industrial micromechanic processes. With only 2 lithography steps, a hypodermic needle tip profile is achieved. Using the fabricated microneedles, fluid extraction is experimented on chicken skin mockups. Extraction tests are carried out by inducing a controlled pressure gradient between the two ends of the microneedle channels, generated by loading the chip or by applying vacuum to the chip's backside. The extraction of more than 1 μL of fluid in 20 minutes is demonstrated with a maximum applied pressure gradient of 500 mbar. A correlation between the extraction rate efficiency and needles' density is observed, both for short and long extraction times. These results provide the first demonstration of <i>in vitro</i> interstitial fluid collection under controlled experimental conditions using silicon hollow microneedles fabricated with standard micro electro mechanical systems (MEMS) fabrication technology and minimal steps. Based on the obtained data, a comparison is drawn between pressure load and vacuum as drivers for ISF extraction, according to modelling and controlled experiments.