Composite Metal/Ceramic Bearings for THA Implants

描述(由申请人提供)：开发材料的影响 具有增强的断裂韧性、抗损伤、可靠性和超低 佩戴对整形外科社区非常感兴趣，因为它直接 解决了一个重要的临床问题--消除磨损颗粒介导的THA 植入失败。在第一阶段，我们朝着解决这个问题迈出了重要的一步 通过成功地展示一种新型陶瓷材料来解决中心问题 优异的机械性能。骨折强化50% 韧性，50%的威布尔模数和显著的抗损伤性 对传统陶瓷进行了演示。因此，我们已经能够确定 材料，从安全和设计方面来说，将有明显更低的 在活体内发生脆性破坏的风险。此外，我们已经能够应用 与CoCr连接的陶瓷。从生物兼容性的角度来看，不是 预计在体内会产生不良反应。早期磨损性能结果 由这些陶瓷制成的头/杯部件也清楚地显示出超低 磨损特性，磨损量比 现在请看Cocr-PE。在第二阶段，我们建议通过以下方式扩大这些有希望的成果 使用严格的统计有效性优化元件设计公差 人工全髋关节植入物静强度和疲劳强度的表征 成分，并进行全面的体外和体内试验 生物相容性评价。我们还建议将磨损试验(n=6)扩展到 在髋关节模拟器中进行1000万次循环，以确认 优化组件。主要的整形外科植入物制造商已经表示 有兴趣就小说的评估和优化进行合作 陶瓷设计。 建议的商业应用： 安全性(机械和生物)和功能(超低磨损)和与CoCR的兼容性提供了一种新的轴承材料组合，有望消除困扰THA磨损碎屑介导的骨溶解和种植体失败的中心问题。一个确定材料安全性和功能的综合计划将有助于加快这些植入物在第三阶段的商业化进程。

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.