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

这个小企业创新研究（SBIR）第一阶段项目的更广泛的影响/商业潜力解决了当前与骨科损伤和手术发生率增加相关的挑战。 这项技术将在美国和全球范围内稳定和修复骨折。创伤、退行性骨疾病和骨肿瘤通常会导致骨折，需要进行称为髓内钉的手术。髓内钉是指将金属植入物钉入骨内以稳定骨折。这种手术通常会导致并发症，如感染、肢体旋转和无法实现完全刚性，最终可能导致患者不适，并因翻修手术而显著增加成本。因此，迫切需要一种髓内钉技术，该髓内钉技术侵入性较小、具有成本效益并且可根据患者的解剖学要求定制，以能够改善骨折愈合并避免繁重的翻修手术。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，植入物的取出应该是微创的，并且不会引起任何额外的发病率。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髓内（IM）套筒系统的开发，该系统具有原位、光固化和可移除的聚合物树脂系统。有四个主要目标：1）设计和开发多层IM套管原型，2）合成和优化IM套管中的原位可光聚合的聚合树脂系统，3）使用微创工具和方法从IM套管中去除固化的聚合树脂系统，和4）体外、体内生物相容性，并在羊尸体胫骨中演示定制的IM原型装置。这项研究将产生新的知识，设计和合成一种新的聚合物配方与添加剂，有助于快速凝固与改善机械性能。 该项目还将利用现有的去除技术提取光固化聚合物。对于医生来说，这项研究可能会带来新的微创治疗方法，从而大大缩短手术时间，提高患者恢复时间。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 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.