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

I-Corps项目更广泛的影响/商业潜力是基于3D打印开发用于药物输送和其他应用的微针技术。增材制造是一项很有前途的技术，可用于制造可定制的、复杂的、具有成本效益的微针阵列（MNAs）。MNA装置是一种微米大小的针头，它穿过组织（皮肤）的外层，以蛋白质、分子和/或肽的形式将药物输送到体内。MNAs被认为是无痛、微创的设备。目前，使用传统技术（如成型、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备，可定制性有限，并且缺乏特定MN参数的灵活性。该技术可以更好地控制几何参数，如亚毫米高度、尖端锐度和高纵横比。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界面。I-Corps项目的基础是开发微针阵列（MNA）装置，这种装置是一种微米大小的针，可以穿透皮肤外层（表皮），将药物输送到体内。提出的技术是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 μ m - 100 μ m分辨率的高质量MNA器件。微针的尖端高度可达200µm - 800µm，直径可达50µm - 200µm。利用这种先进的SLA制造技术，可以制造出圆锥形、锥体、四面体、角状、蜂巢状、箭头状等不同形状的MNAs，具有较高的保真度和力学性能。提出的微针技术可以弥补目前的治疗模式，并且可以扩大规模进行大规模透皮应用。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贴片将被设计成具有优越的机械强度和穿刺能力，适用于医院、流动外科中心和专科诊所的经皮给药应用。这项技术最初的市场目标是糖尿病诊断，为1型糖尿病治疗提供胰岛素和调节血糖。此外，这些MNAs可能提供治疗效率，安全，无痛穿透皮肤，可能很容易适应其他药物输送方式。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

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.