SBIR Phase I: Design and Development of Minimally-Invasive Orthopedic Fracture Fixation Using Intramedullary Sleeve and Injectable, Light-Triggered Bone Cement

这个小型企业创新研究(SBIR)第一阶段项目的更广泛的影响/商业潜力解决了与骨科损伤和手术发生率增加相关的当前挑战。这项技术将在美国和全球稳定和修复骨折。创伤、退行性骨病和骨肿瘤通常会导致骨折，需要一种称为髓内钉的手术。髓内钉包括用钉子固定金属植入物以稳定骨折。这种手术通常会导致感染、肢体旋转和无法达到完全僵硬等并发症，最终可能会导致患者不适，并因翻修手术而显著增加成本。因此，迫切需要一种侵入性更小、成本效益更低、可根据患者的解剖要求定制的髓内钉技术，以提高骨折愈合并避免繁琐的翻修手术。当需要额外的矫正手术来治疗任何术后感染或手术放置错误时，植入物的移除应该是侵入性较小的，并且不会造成任何额外的并发症。目前还没有这种经过验证的技术可以满足上述标准。该项目将主要集中于开发一种具有原位、光固化和可拆卸的聚合物树脂系统的髓内(IM)套筒系统。主要有四个目标：1)设计和开发多层IM套筒原型，2)IM套筒中AM原位可光聚合聚合物树脂系统的合成和优化，3)使用微创工具和方法将固化的聚合物树脂系统从IM套筒中移除，以及4)体外、体内生物相容性，并在绵羊身体胫骨上展示定制的IM原型装置。这项研究将在设计和合成含有添加剂的新型聚合物配方方面产生新的知识，这种添加剂有助于快速固化并改善机械性能。该项目还将使用现有的去除技术提取光固化聚合物。对于医生来说，这项研究可能会产生新颖的微创治疗方法，可以大幅减少手术时间并改善患者的恢复时间。这一奖项反映了NSF的法定使命，并通过使用基金会的智力优势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 Small Business Innovation Research (SBIR) Phase I project addresses the current challenges associated with an increase in the incidence of orthopedic injuries and surgeries. The technology will stabilize and repair broken bones in the US and globally. Trauma, degenerative bone diseases, and bone tumors often result in broken bones that require a procedure called intramedullary nailing. Intramedullary nailing involves nailing metallic implants to bones stabilize bone fractures. This procedure often results in complications such as infection, rotated limbs, and failure to achieve complete rigidity, which may eventually lead to patient discomfort and significantly increased costs due to revision surgeries. Consequently, there is an urgent need for an intramedullary nail technology that is less invasive, cost effective, and customizable to the patient’s anatomical requirements to enable improved bone fracture healing and avoid burdensome revision surgeries. When additional corrective surgery is required to treat any post-operative infections or surgical placement mistakes, the implant removal should be less invasive and not cause any additional morbidity. There are currently no such proven technologies available that meet the above criteria. This project will primarily focus on the development of an intramedullary (IM) sleeve system with an in situ, photocurable, and removable polymeric resin system. There are four main objectives: 1) design and development of a multi-layered IM sleeve prototype, 2) synthesis and optimization of am in situ photopolymerizable polymeric resin system in the IM sleeve, 3) removal of the cured polymeric resin system from the IM sleeve using minimally invasive tools and methods, and 4) in vitro, in vivo biocompatibility, and demonstration of the customized IM prototype device in a sheep cadaveric tibia bone. The research will generate new knowledge in designing and synthesizing a novel polymer formulation with additives that helps in fast setting with improved mechanical properties. The project will also enable extraction of photocured polymers using existing removal technologies. For physicians, this research could result in novel, minimally invasive treatments that could drastically reduce the surgical time and improve the patient recovery times.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.