Patient-Tailored Selective Laser Melt-Fabricated Plates for Repair of Foot and Ankle Pathology

 描述(由申请人提供)：该项目的目标是开发新的，患者特定的，几何复杂的，钛(钛)合金板材，通过添加制造(AM，也称为3D打印)制造，用于足部和脚踝应用。这些钢板将提供卓越的固定和机械性能，同时最大限度地减少钢板体积。足部和脚踝手术是很常见的，在美国，仅修复拇囊炎一项，每年就有超过20万例手术。四肢骨折修复市场预计将达到45亿美元 到2017年每年。目前用于足踝修复的钢板很简单，主要是二维几何形状，不能很好地符合足部和脚踝骨骼的复杂解剖。因此，外科医生花费时间弯曲钢板以适应患者的解剖结构，这并不总是保证充分的固定。拟议的AM创建的板材具有量身定做的架构，将通过提高适合性、保持强度、减少轮廓和降低成本来提高卓越的稳定性。通过使用选择性激光熔化钛合金的AM技术，可以根据患者的解剖结构定制几何形状，从而实现更好的适合性，减少手术时间。复杂的结构，如毛孔、内部通道和薄壁部分，将有助于骨生长，优化机械性能，并减少软组织刺激。通道也可以作为缝合或移植材料的附着点。此外，AM板的使用降低了与传统制造相关的成本，在传统制造中，模具和模具需要在患者之间更换。这一拟议的项目将通过三个具体目标来实现。Aim 1将通过基于解剖成像的模型的有限元分析(FEA)，定制具有复杂3D特征的患者专用F&A钢板的设计。这一目标将通过基于身体足部解剖成像创建设备的3D模型并评估模型在多种临床加载场景下的性能来实现。AIM 2将通过比较AM制造的板材和传统制造的板材的机械性能和生产效率来评估AIM 1的设计。这一目标将决定每种方法的生产成本、时间和浪费，并比较单调和循环加载条件下的力学性能。AIM 3将评估AM创建的钢板在AIM 1中成像的身体足部标本中针对特定病理的适合性和机械性能。这一目标旨在通过生产AM创建的钢板来适应不同病理情况的复杂骨骼，从而验证先前的目标。钢板与骨的结合情况和力学性能将分别通过显微CT和力学测试进行评估。第一阶段的成功完成将展示由患者量身定做的新型AM创建的钢板，用于治疗能够承受负荷条件的足部和脚踝病理。这些钢板将增强固定和稳定性，从而改善临床愈合和融合。

 DESCRIPTION (provided by applicant): The objective of this project is to develop novel, patient-specific, geometrically complex, Titanium (Ti) alloy plates made by additive manufacturing (AM, also called 3D-printing) for foot and ankle applications. These plates will offer superior fixation and mechanical performance, while minimizing the plate bulk volume. Foot and ankle surgeries are common, where over 200,000 are performed each year in the U.S. for bunion repair alone. The market for extremity fracture repair is expected to reach $4.5 Billion annually by 2017. Current plates for foot and ankle repair are simple with mainly two-dimensional geometries, which do not conform well to the complex anatomy of the bones in the foot and ankle. Therefore, surgeons spend time bending plates to fit patient anatomy, which does not always guarantee sufficient fixation. The proposed AM-created plates with tailored architectures will promote superior stability by improving fit, maintaining strength, reducing profile, and reducing cost. By using the AM technique of selective laser melting of Ti alloy, the geometry can be tailored to the patient anatomy, which will achieve better fit and reduce surgery time. Complex architectures, such as pores, internal channels, and thin-walled sections, will aid in bone growth, optimization of mechanical properties, and reduction of soft tissue irritation. Channels can also serve as attachment points for suture or graft material. In addition, the use of AM plates decreases costs associated with traditional manufacturing where molds and tooling would need to be changed between patients. This proposed project will be accomplished through three specific Aims. Aim 1 will tailor the design of patient-specific F&A plates featuring complex 3D features through finite element analysis (FEA) of models based upon anatomic imaging. This Aim will be achieved by creating 3D models of devices based upon cadaveric foot anatomic imaging and evaluating the models' performance under multiple clinical loading scenarios. Aim 2 will assess the designs from Aim 1 by comparing AM-created plates and traditionally manufactured plates for mechanical performance and production efficiency. This Aim will determine the production cost, time, and waste for each method and compare the mechanical performance under monotonic and cyclic loading regimes. Aim 3 will evaluate the fit and mechanical performance of AM-created plates for specific pathologies in the cadaveric foot specimens imaged in Aim 1. This Aim serves to validate the prior Aims by producing AM-created plates to fit complex bones with varying pathologies. The plate to bone apposition and mechanical performance will be evaluated by micro-CT and mechanical testing, respectively. The successful completion of Phase I will demonstrate novel, patient-tailored, AM-created plates for treating foot and ankle pathologies that can sustain load-bearing conditions. These plates will enhance fixation and stability, leading to improved clinical healing and fusion.