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

这个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、患者特定的设备来进行颅面重建和增强。 目前的重建支撑装置在解剖学和功能上不是患者特异性的，不允许精确配合，需要耗时且通常多次手术，具有次优的组织向内生长，并且可能迁移，导致组织侵蚀。由于全身健康问题和对植入物的不良免疫反应，永久性美容植入物通常需要取出。此外，由于定制患者专用设备所涉及的基础设施和运营支出的高昂成本，传统制造无法满足创伤性和罕见疾病人群的需求。所提出的3D打印生物组织平台允许定制解剖和功能上的患者特定设备，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，所提出的技术可以提供上级患者的结果，大大减少成本，手术时间和住院时间，这可能是一个好处，病人，医院和健康insurers.This I-Corps项目是基于开发的三维生物组织平台的颅面重建和增强行业与定制，患者特定的设备（包括耳，鼻支架和扩张移植）。 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工艺，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，可重现和可预测的美学结果。 多尺度计算模拟软件和专有工具被用来设计结构合理的植入物作为支架在头部和颈部重建手术。3D打印可吸收生物组织技术的安全性和有效性已经在FDA扩大使用的25名患者中植入了气道支持装置。该项目的目的是探索技术在颅面重建和隆鼻行业的更广泛应用，特别是鼻整形和耳鼻重建手术。该奖项反映了NSF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.