CERAMIC TIBIA FOR MOBILE BEARING KNEE

航空航天/工程应用的最新发展和经验表明，层状氧化锆/钢复合材料具有超低磨损的明显优势。这在消除磨损颗粒介导的骨溶解和随后的种植失败方面具有很大的潜力。磨损率与陶瓷/陶瓷偶相当，磨损量比最好的陶瓷/PE偶低2-3个数量级。然而，与陶瓷/陶瓷偶联相比，所提出的复合陶瓷/金属偶联减轻了由脆性骨折引起的主要临床问题。在一种消除PE磨损碎片和降低脆性失效风险的新方法中，提出了一种复合陶瓷胫骨组件与Co-Cr股骨组件接合。来自工程领域的发展和经验被建议应用于生物医学植入物的应用，并有望带来卓越的耐磨性（与最好的陶瓷/陶瓷偶相媲美），同时消除PE胫骨组件。韧性，比传统陶瓷增强2倍，显著降低胫骨衰竭的风险。这是特别相关的移动穿戴膝盖设计，其中增加的活动范围和由此产生的磨损被观察到。第一阶段将建立优越的材料性能，并显着降低磨损率。在第二阶段，将进行磨损模拟器测试以及设计和制造工艺优化。超韧性复合陶瓷胫骨组件与Co-Cr股骨组件的新型组合将导致可忽略不计的磨损碎片和植入物失效。适应和增强已建立的工程陶瓷与已建立的Co-Cr髁组件的关节将大大提高商业应用。

Recent developments and experience in aerospace/engineering applications has established a clear superiority of layered composite zirconia/steel couples as ultra low wear. This has a great potential for implant applications in virtually eliminating wear particle mediated osteolysis and consequent implant failures. Wear rates comparable to ceramic/ceramic couples with demonstrated 2-3 orders lower wear volume than the best ceramic/PE couples can be expected. In contrast to the ceramic/ceramic couples however, the proposed composite ceramic/metal couple alleviates the major clinical concern stemming from brittle fracture. In a novel alternative approach to eliminating PE wear debris and lowering risk of brittle failure, a composite ceramic tibial component articulating against a Co-Cr femoral component is proposed. Developments and experience from the engineering fields is proposed to be applied to biomedical implant applications and is expected to lead to both superior wear resistance (comparable to the best ceramic/ceramic couples), with elimination of the PE tibial component. Toughness, enhancement of 2x over conventional ceramics significantly reduces risk of tibial failure. This is particularly relevant to mobile wearing knee designs where increased range of motion and resultant wear is observed. Phase 1 will establish the superior materials properties and demonstrate significantly reduced wear rates. In Phase 2, wear simulator tests will be conducted along with design and manufacturing process optimization. PROPOSED COMMERCIAL APPLICATION The novel combination of an ultra-tough composite ceramic tibial components articulating against Co-Cr femoral components will lead to negligible wear debris and implant failures. Adaptation and enhancement of an established engineering ceramic for articulation with the established Co-Cr condylar components will greatly enhance commercial applications.