PFI-TT: 3D Printed Tissue Implants for Facial Surgery

该创新技术转化伙伴关系（PFI-TT）项目的更广泛影响/商业潜力是开发用于面部手术的3D打印组织植入物平台。该平台提供了设计和快速制造组织重建植入物的能力。将对材料供应链进行全面分析，以确定任何潜在风险，并制定减轻风险的策略。此外，将评估和优化两种不同的3D打印制造工艺，以建立经济上可行的、可复制的材料/3D打印制造工艺，适合商业化。这项技术提供了比现有替代方案更好的选择，对患者和外科医生都有好处。好处包括消除痛苦的手术，降低成本和相关风险，并显著改善患者的预后。该平台旨在满足各种面部重建需求，因为3D打印可以生产从标准化尺寸到量身定制的患者特定设计的几何复杂植入物。该项目的最终目标是将现成的医用级材料与可复制的3D打印工艺相匹配，该工艺可以作为多种类型面部植入物的通用平台。该项目旨在评估不同3D打印方法对成本、时间的影响，最重要的是，3D打印聚己内酯（PCL）植入物的性能。此外，该项目旨在了解制造过程的可变性及其对制造设备的材料和机械行为的影响。这不仅从研究基础的角度来看是至关重要的，而且从临床和商业化的角度来看也是如此。该项目将涉及使用各种3D打印技术（如激光烧结和材料挤压）对市售医疗级PCL粉末/颗粒进行全面评估。制造的设备将进行材料表征和机械测试，以评估和比较它们的性能。该项目的成功完成将为生产可在动物模型中进行测试的植入物奠定基础，这是获得FDA许可将这些植入物推向市场的必要步骤。这项工作不仅有助于提高我们对该领域的基本理解，而且还有助于确定最有效的3D打印技术，以生产高质量的基于pcl的面部植入物。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 Partnerships for Innovation - Technology Translation (PFI-TT) project is to develop a platform for 3D printing tissue implants for facial surgery. This platform provides the capability to design and rapidly manufacture implants for tissue reconstruction. A comprehensive analysis of the material supply chain will be conducted to identify any potential risks and develop strategies to mitigate them. Additionally, two different 3D printing manufacturing processes will be assessed and optimized to establish an economically viable, and reproducible material/3D printing manufacturing process suitable for commercialization. The technology would benefit both patients and surgeons by providing superior options than current alternatives. Benefits include eliminating painful surgeries, reducing costs and associated risks, and significantly improving patient outcomes. The platform is designed to meet various facial reconstruction needs, as 3D printing enables the production of geometrically complex implants that range from standardized sizes to tailored patient-specific designs. The ultimate goal of this project is to match a readily available medical grade material with a reproducible 3D printing process that can serve as a versatile platform for multiple types of facial implants. The proposed project seeks to evaluate the impact of different 3D printing methods on the cost, time, and most importantly, the performance of 3D printed polycaprolactone (PCL) implants. Additionally, the project aims to understand the variability of manufacturing processes and its effect on the material and mechanical behavior of the manufactured devices. This is critical not only from a research basic point of view, but also from a clinical and commercialization perspective. The project will involve a comprehensive evaluation of commercially available medical-grade PCL powders/pellets using various 3D printing techniques, such as laser sintering and material extrusion. The manufactured devices will undergo material characterization and mechanical testing to assess and compare their performance. Successful completion of this project will create a foundation to enable the production of implants that can be tested in animal models, a necessary step for obtaining FDA clearance to bring these implants to market. This work will not only aid in enhancing our fundamental understanding of the field but will also help identify the most efficient and effective 3D printing technique for producing high-quality PCL-based facial implants.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.