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项目的更广泛的影响是基于用于处理长骨骨折（例如肱骨，股骨和胫骨）的骨板的发展，该骨骼是单件且机械符合（柔性）的骨板。该板通过减少骨折的非工会来改善临床护理结果，这对于患者在身体，精神和财务上非常繁重。该技术改善了女性的股权，她们是否受到长骨骨折中非工会的不成比例影响。该技术可能会降低长骨非工会率（目前为5-20％），可节省约68,000美元/患者。这项研究为骨科中其他应用程序的未来工作提供了信息。本I-Corps项目利用体验式学习以及对行业生态系统的第一手研究来评估技术的翻译潜力。该解决方案基于基本知识的发展，该知识建立了单件式，柔性，裂缝固定板的可行性，局限性和一般原理，用于在长骨断裂愈合中提供受控的微功能。该技术利用机械合规来实现这种微功能。创新包括：1）单件式，线性运动符合线性机理骨板的设计，相对于替代动态板，零件计数和组装降低； 2）选择柔性元素的几何形状的新型分析模型，这些模型允许在不改变材料的情况下为各种临床场景调整板刚度； 3）用于加工薄柔性成员的减法和添加剂制造方法，必须忍受许多负载周期； 4）保留当前刚性板中存在的临界板特征（即锁定螺钉孔，不锈钢材料，板面骨面的有限接触区域），以保留手术技术，并使用食品和药物给药创建可行的调节清除途径。这项创新为外科医生提供了一种资源，以减少板条裂缝的僵硬，这已证明可以减少非工会，而没有引入新材料，摩擦和磨损，多个组件的组装或修改的手术技术。该奖项反映了NSF的法定任务，并通过评估智力效果和广泛的评估，并被认为是值得评估的，并具有值得的评估。