Microneedle (MN) technologies have gained interest for biomedical applications, ranging from drug delivery to sensing and tissue sampling in skin and internal organs. The microscale feature of MN systems allows the accommodation of therapeutics from small drugs to macromolecule biologics and even living cells. Additionally, it permits body fluid extraction when inserted into tissues. The integration of MNs with other technologies, such as stimuli-responsive materials, smart electronics and wearables, facilitates precision drug delivery, dynamic monitoring and closed-loop theranostic functions. In this Review, we discuss MN materials, structures and engineering approaches, focusing on the integration of MNs with biomedical devices. Finally, we provide a survey on clinical applications of MNs and discuss opportunities and challenges for the translation and commercialization of MNs as biomedical devices.

微针 (MN) 技术在生物医学应用中引起了人们的兴趣，从药物输送到皮肤和内脏器官的传感和组织采样。MN 系统的微观特征允许适应从小药物到大分子生物制剂甚至活细胞的治疗。此外，当插入组织时，它允许提取体液。MN 与刺激响应材料、智能电子产品和可穿戴设备等其他技术的集成，有利于精准药物输送、动态监测和闭环治疗诊断功能。在这篇综述中，我们讨论了微纳米材料、结构和工程方法，重点关注微纳米与生物医学设备的集成。最后，我们对 MN 的临床应用进行了调查，并讨论了 MN 作为生物医学设备的转化和商业化的机遇和挑战。