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

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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.