Patterned Microtexture for Improved Durability of Orthopedic Knee Implants

描述(申请人提供)：在美国，每年约有60万例全膝关节置换术(TKR)手术，年总费用为150亿美元，目前有近450万美国人生活在TKR植入物中。TKR装置在使用十年后存活率急剧下降，主要原因是机械磨损。该项目的目标是通过对TKR进行改性以提高滑液的润滑性能，从而从根本上提高TKR的耐用性。目前对抗种植体磨损的范例是通过使用超光滑的滑动表面来最小化摩擦。相反，我们的方法将为植入物的股骨部件增加一种表面纹理，旨在以低滑动速度创建流体动力润滑。最新可用的超短脉冲激光将被用来在COCR股骨假体上以微米级酒窝阵列的形式产生设计的纹理。激光器将以一种不会对凹坑之间的表面粗糙度或材料固有的优异磨损性能产生不利影响的方式来实现这一点。这个第一阶段的项目将验证这样一个假设，即如此纹理的表面可以以真实的膝关节滑动速度产生完全的流体润滑，以减少最终导致植入物失败的摩擦和磨损。这项研究有可能改变目前关于种植体轴承表面的研究范式。这一知识可能会产生新一代截然不同、寿命更长的整形外科植入物。用于修改植入物的方法激光毛化方法是一种公认的工业过程，它是负担得起的，并将允许润滑增强技术的短期过渡，以造福患者并总体节省医疗保健系统。 公共卫生相关性：目前有近450万美国人受益于全膝关节置换术(TKR)，新的手术正在以每年60万(和150亿美元)的速度进行，而且还在不断增加。TKR种植体的统计失败率在服役10年后显著增加。该项目旨在大大减少TKR的磨损和延长其寿命，以避免患者疼痛和残疾，并降低医疗保健成本和与并发症和翻修手术相关的风险。1

DESCRIPTION (provided by applicant): Each year in the US, approximately 600,000 total knee replacement (TKR) surgeries are performed at a total annual cost of $15B and nearly 4.5M Americans are currently living with a TKR implant. The survival rate of TKR devices declines dramatically after ten years of use due primarily to mechanical wear. The objective of this STTR project is radically improve the durability of TKRs by modifying them to enhance the performance of the lubricating synovial fluid. The current paradigm for combating implant wear is to minimize friction by employing ultra-smooth sliding surfaces. In contrast, our approach will add to the implant's femoral component a surface texture that is designed to create hydrodynamic lubrication at low sliding velocities. Newly available ultra short pulse lasers will b used to create the designed texture on a CoCr femoral component in the form of arrays of micron-scale dimples. The lasers will achieve this in a manner that does not adversely affect the surface roughness between dimples, or the intrinsically excellent wear properties of the material. This Phase 1 project will verify the hypothesis that a surface so textured can generate full fluid lubrication at realistic knee joint sliding velocities to reduce friction and wear that eventually lead to implant failure. This research has the potential to shift current paradigms about implant bearing surfaces. This knowledge could produce a new generation of radically different, longer-lasting orthopedic implants. The method laser texturing method for modifying the implants is an established industrial process that is affordable and will allow near term transition of the lubrication enhancement technology for the benefit of patients and overall savings to the health care system. PUBLIC HEALTH RELEVANCE: Nearly 4.5 million Americans are currently benefitting from total knee replacement (TKR) implants, and new surgeries are being performed a rate of 600,000 (and $15B) per year and accelerating. The statistical failure rate of TKR implants increases dramatically after 10 years of service. This project seeks to greatly reduce wear and extend life of TKRs to avoid patient pain and disability, and reduce health care costs and risks associated with complications and revision surgery. 1