Composite Metal/Ceramic Bearings for THA Implants

描述（由申请人提供）：开发材料的含义 具有增强的断裂韧性、抗损伤性、可靠性和超低 磨损是骨科界的重大兴趣，因为它直接 解决了一个重要的临床问题-消除磨损碎屑介导的THA 植入物失效。在第一阶段，我们朝着解决这个问题迈出了重要的一步。 通过成功展示一种新型陶瓷材料， 上级机械性能。骨折部位增强50% 韧性、50%威布尔模量和显著的抗损伤性， 展示了传统陶瓷。因此，我们能够确定 从安全和设计方面来看， 体内脆性破坏的风险。此外，我们已经能够适应 陶瓷与钴铬关节。从生物相容性方面来看，没有 预期在体内会产生副作用。的早期磨损性能结果 由这些陶瓷制成的股骨头/髋臼杯组件也清楚地显示出超低的 磨损特性，磨损量比 介绍CoCr-PE。在第二阶段，我们建议通过以下方式扩展这些有希望的结果： 使用严格的统计有效的 方法，表征THA植入物的静态和疲劳强度 组件，并进行全面的体外和体内 生物相容性评价。我们还建议将磨损试验（n=6）扩展至 在髋关节模拟器中进行1000万次循环，以确认 优化组件。主要的骨科植入物制造商表示， 对合作评估和优化小说的兴趣 陶瓷设计 拟定商业应用： 安全性（机械和生物学）和功能（超低磨损）以及与CoCr的兼容性相结合，提供了一种新的关节面材料套件，有望消除THA -磨损碎屑介导的骨质溶解和植入物失效的核心问题。一项旨在确定材料安全性和功能的创新计划将有助于加速这些植入物在第三阶段的商业化。

DESCRIPTION (Provided by Applicant): The implications of developing materials with enhanced fracture toughness, damage resistance, reliability and ultra low wear is of significant interest to the orthopedic community, since it directly addresses a vital clinical concern- eliminating wear debris mediated THA implant failures. In Phase I we made a significant step towards addressing this central issue by successfully demonstrating a novel ceramic material with superior mechanical properties. An enhancement of 50 percent in fracture toughness, 50 percent in weibull modulus and significant damage resistance over conventional ceramics was demonstrated. Thus, we have been able to establish materials which, from a safety and design aspect, will have significantly lower risk of brittle failure in vivo. Furthermore, we have been able to adpat the ceramics for articulation with CoCr. From a bio-compatibility aspect, no adverse effects are expected in-vivo. Early wear performance results of head/cup components made from these ceramics also clearly show the ultra low wear characteristics, with wear volumes 2-3 orders of magnitude lower than present CoCr-PE. In Phase II, we propose to extend these promising results by optimizing the component design tolerances using a rigorous statistically valid approach, characterizing the static and fatigue strength of THA implant components, and performing a comprehensive in-vitro and invivo bio-compatibility evaluation. We also propose to extend the wear tests (n=6) to 10 million cycles in a hip simulator to confirm the functionality of the optimized components. Major orthopedic implant manufacturers have expressed interest in collaborating on the evaluation and optimization of the novel ceramic designs. PROPOSED COMMERCIAL APPLICATION: The combination of safety (mechanical and biological) and function (ultra-low wear) and compatibility with CoCr offers a new bearing materail set that promises to eliminate the central issue plaguing THA - wear debris mediated osteolysis and implant failures. A comprehanesive program to establish the safety and function of the materials will help speed the commercialization of these implants in Phase III.