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

I-Corps：用于长骨骨折的机械顺应性骨折固定板的平移潜力

• 批准号: 2410029
• 负责人: Jared Butler
• 金额: $ 5万
• 依托单位: Pennsylvania State Univ University Park
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2024
• 资助国家: 美国
• 起止时间: 2024-03-01 至 2025-02-28
• 项目状态: 未结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2410029&HistoricalAwards=false
• 关键词: Corps; Translation; Potential; Mechanically; Compliant

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.

该I-Corps项目的更广泛影响是基于用于治疗长骨（如肱骨、股骨和胫骨）骨折的骨板的开发，该骨板是单件式且机械顺应性（柔性）。接骨板通过减少骨折不愈合改善了临床护理结果，骨折不愈合对患者的身体、精神和经济造成了极大的负担。这项技术提高了女性的公平性，因为她们受到长骨骨折不愈合的不成比例的影响。该技术可降低长骨骨不连率（目前为5 - 20%），每例患者可节省约68，000美元。这项研究为骨科其他应用的未来工作提供了信息。这个I-Corps项目利用体验式学习，结合对行业生态系统的第一手调查，评估该技术的转化潜力。该解决方案基于基础知识的发展，这些基础知识确定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受控的微运动。该技术利用机械顺应性来实现这种微动。创新包括：1）单件式线性运动柔顺机构接骨板的设计，相对于替代动态接骨板减少了部件数量和组装; 2）用于选择柔性元件几何形状的新颖分析模型，其允许在不改变材料的情况下针对各种临床情况调整接骨板刚度; 3）用于加工必须承受许多负载循环的薄柔性构件的减材和增材制造方法;以及4）保留当前刚性板中存在的关键板特征（即锁定螺钉孔，不锈钢材料，接骨板骨侧接触区域有限）既保护手术技术，又与食品和药物管理局建立一个可行的监管许可途径。这一创新为外科医生引入了一种资源，以降低接骨板骨折的刚度，这已被证明可以减少骨不连，而无需引入新材料，摩擦和磨损，多个组件的组装或修改手术技术。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。