I-Corps: 3D Printing of Microneedles for Transdermal Drug Delivery

这个I-Corps项目更广泛的影响/商业潜力是开发基于3D打印的药物输送和其他应用的微针技术。 增材制造是一种有前途的技术，可用于制造可定制的、复杂的和具有成本效益的微针阵列（MNA）。MNA装置是微米尺寸的针，其刺穿组织（皮肤）的外层以蛋白质、分子和/或肽的形式将药物递送到体内。MNAs被认为是无痛的微创器械。目前，使用传统技术（如模塑、化学湿法蚀刻和直接激光微加工）开发的MNA贴片需要先进的制造设施，可定制性有限，并且在特定MN参数上缺乏灵活性。所提出的技术允许对诸如亚毫米高度、尖端锐度和高纵横比的几何参数进行上级控制。 MNA贴片的应用包括药物递送、电刺激、化学生物传感、电生物信号记录和中性接口。I-Corps项目基于微针阵列（MNA）设备的开发，微针阵列是微米尺寸的针，刺穿皮肤外层（表皮）将药物递送到体内。 所提出的技术基于可定制的立体光刻（SLA）技术，用于使用生物相容性和可生物降解的材料制造10 µm - 100 µm分辨率的高质量MNA器件。微针可以分别被制造为具有200 μm - 800 μm的尖端高度和50 μm - 200 μm的直径。 使用这种SLA先进制造技术，可以制造具有高保真度和机械性能的各种MNA，例如圆锥形、金字塔形、四面体形、角形、蜜蜂结构和箭头形。所提出的微针技术可以桥接当前的治疗模式，并且适合于大规模经皮应用的规模化。 此外，3D打印的微针可以嵌入药物，为各种医学治疗提供可调的药物释放动力学。这些MNA贴剂将被设计为具有上级机械强度和刺穿能力，用于医院、门诊手术中心和专科诊所的经皮给药应用。该技术的最初市场目标是糖尿病诊断，以提供胰岛素并调节1型糖尿病治疗的葡萄糖。此外，这些MNA可以提供治疗效率以及安全、无痛的皮肤渗透，可以很容易地适用于其他药物输送方式。该奖项反映了NSF的法定使命，并且通过使用基金会的知识价值进行评估，被认为值得支持和更广泛的影响审查标准。

The broader impact/commercial potential of this I-Corps project is the development of a microneedle technology for drug delivery and other applications based on 3D printing. Additive manufacturing is a promising technology that may be used for fabrication of customizable, complex, and cost-effective microneedles arrays (MNAs). MNA devices are micron-sized needles that pierce the outer layer of tissue (skin) to deliver drugs in the form of proteins, molecules, and/or peptides into the body. MNAs are considered painless, minimally invasive devices. Currently, MNA patches developed using traditional technologies such as molding, chemical wet etching, and direct laser micromachining require advanced manufacturing facilities, have limited customizability, and lack flexibility over specific MN parameters. The proposed technology allows superior control over geometric parameters such as sub-millimeter height, tip sharpness, and high-aspect ratio. Applications of MNA patches include drug delivery, electric stimulation, chemical biosensing, electrical biosignal recording, and neutral interfaces.This I-Corps project is based on the development of microneedle array (MNA) devices that are micron-sized needles that pierce the outer layer of skin (epidermis) to deliver drugs into the body. The proposed technology is based on a customizable stereolithography (SLA) technique for fabricating high quality MNA devices with 10 µm - 100 µm resolution using biocompatible and biodegradable materials. The microneedles may be fabricated with tip heights of 200 µm - 800 µm and diameters of 50 µm - 200 µm, respectively. Using this SLA advanced manufacturing technique, various MNAs such as conical-, pyramidal-, tetrahedron-, angled, honeybee structure, and arrowhead-shaped may be fabricated with high fidelity and mechanical properties. The proposed microneedle technology can bridge current treatment modalities and is amenable to scale-up for large-scale transdermal applications. Moreover, 3D printed microneedles may be embedded with pharmaceuticals providing tunable drug release kinetics for a variety of medical treatments. These MNA patches will be designed to possess superior mechanical strength and piercing capacity for transdermal drug delivery applications in hospitals, ambulatory surgical centers, and specialty clinics. The initial market target of this technology is diabetes diagnostics to deliver insulin and regulate glucose for Type 1 diabetes treatment. In addition, these MNAs may provide therapeutic efficiency, and safe, painless penetration through skin that may be easily adapted for other drug delivery modalities.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.