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

这个i-Corps项目的更广泛的影响是基于开发一种用于治疗长骨(如肱骨、股骨和胫骨)骨折的骨板，它是一种整体式和机械兼容(灵活)的骨板。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、精神和经济造成极大的负担。这项技术改善了女性的公平性，因为她们受到长骨骨折不愈合的影响不成比例。该技术可能会降低长骨不愈合率(目前为5-20%)，为每个患者节省约6.8万美元。这项研究为骨科其他应用程序的未来工作提供了信息。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。该解决方案的基础是基础知识的发展，这些基础知识确立了在长骨骨折愈合中提供受控微运动的单件、柔性骨折固定钢板的可行性、局限性和一般原则。该技术利用机械顺应性来实现这种微动。创新包括：1)设计了一种单件、直线运动柔顺机构骨板，相对于替代的动态钢板减少了部件数量和装配；2)新颖的分析模型选择了柔性元件的几何形状，允许在不改变材料的情况下根据不同的临床场景调整钢板的刚度；3)减法和加法制造必须承受多个加载循环的薄柔性部件；以及4)保留当前刚性钢板中存在的关键钢板特征(即锁定螺纹孔、不锈钢材料、钢板面向骨侧的有限接触区域)，以既保留手术技术，又创建与食品和药物管理局可行的监管审批途径。这项创新为外科医生提供了一种资源，以减少平板骨折的僵硬，这种资源已被证明可以减少骨不连，而不需要引入新材料、摩擦磨损、多个部件的组装或改进的手术技术。该奖项反映了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 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.