I-CORPS: 3D Bio-printing for craniofacial reconstruction

I-Corps项目更广泛的影响/商业潜力是开发3D打印生物组织平台，该平台允许定制，针对患者的颅面重建和增强设备。目前的重建支撑装置在解剖学和功能上不符合患者的要求，不能精确贴合，需要耗时且经常多次手术，组织向内生长不理想，并且可能会迁移，导致组织侵蚀。由于系统健康问题和对植入物的不良免疫反应，永久性美容植入物经常需要拔出。此外，传统制造业无法满足创伤和罕见疾病人群的需求，因为基础设施和定制特定患者设备所涉及的运营支出成本过高。提出的3D打印生物组织平台允许定制解剖和功能特定于患者的设备，可以减少手术时间、麻醉风险、围手术期风险和患者恢复时间。此外，拟议的技术可以提供更好的患者结果，大大减少成本、手术时间和住院时间，这可能对患者、医院和健康保险公司有利。这个I-Corps项目的基础是开发一个3D生物组织平台，用于颅面重建和增强行业，使用定制的、针对患者的设备（包括耳、鼻支架和扩展器移植物）。拟议的3D打印可吸收生物组织技术使用集成的设计和制造过程，允许设备随着时间的推移过渡到天然组织，降低长期感染的风险，并提供安全、可复制和可预测的美学结果。多尺度计算模拟软件和专有工具用于设计结构合理的植入物，用作头颈部重建手术的支架。3D打印可吸收生物组织技术的安全性和有效性已经通过在25名患者中植入气道支持装置得到验证。该项目的目的是探索技术在颅面重建和隆胸行业的更广泛应用，特别是在鼻整形和耳鼻部重建手术方面。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 3D printed bio-tissue platform that allows for customized, patient-specific devices for craniofacial reconstruction and augmentation. Current reconstructive support devices are not anatomically and functionally patient-specific, do not allow for precise fit, require time-consuming and often multiple surgeries, have sub-optimal tissue ingrowth, and may migrate, causing tissue erosion. Permanent cosmetic implants often need to be ex-planted due to systemic health concerns and adverse immune reactions to the implants. Furthermore, traditional manufacturing is unable to address the needs of traumatic and rare disorder populations due to the prohibitive cost of infrastructure and operational expenditures involved in customizing patient-specific devices. The proposed 3D printed bio-tissue platform allows for customized anatomic and functionally patient-specific devices that may reduce operative time, anesthetic risk, perioperative risk, and patient recovery times. In addition, the proposed technology may provide superior patient outcomes with considerable reduction in costs, surgical time, and hospital stays, which may be a benefit to patients, hospitals, and health insurers.This I-Corps project is based on the development of a 3D bio-tissue platform for the craniofacial reconstruction and augmentation industry with customized, patient-specific devices (including ear, nose scaffolds and spreader grafts). The proposed 3D printed resorbable bio-tissue technology uses an integrated design and manufacturing process that allows the devices to transition to native tissue over time, reducing the risk of long-term infections and offering safe, reproducible, and predictable aesthetic outcomes. Multiscale computational simulation software and proprietary toolsare utilized to design structurally-sound implants used as scaffolds in head and neck reconstructive surgery. The safety and efficacy of the 3D printed resorbable bio-tissue technology have been proven with airway support devices implanted in 25 patients under FDA expanded access. The intent of this project is to explore a wider application of technologies in the craniofacial reconstruction and augmentation industry, specifically for rhinoplasty and ear and nose reconstruction surgery.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.