I-Corps: Translation Potential of Mechanically Compliant Fracture Fixation Plates for Long Bone Fractures

I-Corps项目更广泛的影响是基于一种用于治疗长骨骨折（如肱骨、股骨和胫骨）的单片骨板的开发，这种骨板具有机械柔韧性。该钢板通过减少骨折不愈合来改善临床护理结果，骨折不愈合对患者的身体、精神和经济都是极大的负担。这项技术提高了女性的平等地位，因为她们在长骨骨折中不成比例地受到不愈合的影响。该技术可降低长骨不愈合率（目前为5% - 20%），每位患者可节省约68,000美元。这项研究为未来骨科的其他应用提供了参考。这个I-Corps项目利用体验式学习和对行业生态系统的第一手调查来评估该技术的翻译潜力。该解决方案是基于基础知识的发展，该基础知识建立了单片柔性骨折固定板的可行性、局限性和一般原理，用于在长骨骨折愈合中提供可控的微运动。该技术利用机械顺应性来实现这种微运动。创新包括：1)设计了单件线性运动柔性机构骨板，相对于替代动力板减少了零件数量和装配；2)采用新颖的分析模型选择柔性元件的几何形状，在不改变材料的情况下，可以根据不同的临床情况调整钢板的刚度；3)采用减法和增材制造方法加工必须承受多次载荷循环的薄型柔性构件；4)保留现有刚性钢板的关键特征（即锁定螺钉孔、不锈钢材料、钢板面向骨一侧的有限接触区域），既保留手术技术，又获得食品和药物管理局（fda）的可行监管许可。这一创新为外科医生提供了一种减少电镀骨折刚度的资源，这已经被证明可以减少不愈合，而不需要引入新材料、摩擦和磨损、多部件组装或修改手术技术。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 of this I-Corps project is based on the development of a bone plate for treating fractures of long bones (such as the humerus, femur, and tibia) that is a single-piece and mechanically compliant (flexible). The plate improves clinical care outcomes by reducing fracture non-unions, which are extremely burdensome for patients physically, mentally, and financially. The technology improves equity for women, are they are disproportionately affected by non-unions in long bone fractures. The technology may reduce the long bone non-union rate (currently 5 - 20%), saving approximately $68,000/patient. This research informs future work across other applications in orthopedics.This I-Corps project utilizes experiential learning coupled with a first-hand investigation of the industry ecosystem to assess the translation potential of the technology. The solution is based on the development of fundamental knowledge that establishes the feasibility, limitations, and general principles of single-piece, flexible, fracture fixation plates for delivering controlled micromotion in long bone fracture healing. The technology leverages mechanical compliance to achieve this micromotion. The innovation includes: 1) the design of a single-piece, linear motion compliant mechanism bone plate, reducing the part count and assembly relative to alternative dynamic plates; 2) novel analytical models to select geometry of flexible elements, which allow the tuning of plate stiffness for various clinical scenarios without changing the material; 3) subtractive and additive manufacturing methods for machining thin flexible members which must endure many loading cycles; and 4) retaining critical plate features present in current rigid plates (i.e. locking screw holes, stainless steel materials, limited contact regions on the bone-facing side of the plate) to both preserve surgical technique and create a feasible regulatory clearance pathway with the Food and Drug Administration. This innovation introduces a resource for surgeons to reduce the stiffness of plated fractures, which has been shown to reduce non-unions, without the introduction of new materials, friction and wear, assembly of multiple components, or modified surgical technique.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.