Nanostructured Zirconia Ceramics for Joint Prosthetics

描述（由申请人提供）：在关节成形术领域，在美国每年大约有50万人工膝关节和髋关节被植入，随着“婴儿潮一代”年龄的增长，这一数字预计将增加6倍。所有可用于制造髋关节植入物的材料的摩擦学评估表明，由部分稳定（增韧性）的四边形氧化锆（氧化锆掺杂3mol %钇，3YSZ）制造的球形部件与聚乙烯杯相比具有优越的磨损性。与其他材料相比，这些材料在体内为假肢关节提供了更高的预期寿命。美国的陶瓷髋关节市场一直由欧洲制造商主导。最近，欧洲制造的髋关节部件出现了足够多的故障，以至于FDA强制召回所有没有替代品的氧化锆关节。Biopro是由Louis Serafin博士共同创立的密歇根州休伦港公司，是美国唯一获得FDA认证的美国强化氧化锆髋关节供应商，但已不再生产。Tal Materials已经学会了使用可控高能前驱体技术（CONCEPT）生产大量非常高质量的纳米级3YSZ粉末。这些纳米粉末提供了生产韧性氧化锆髋关节的潜力，其性能甚至比原始生产的材料更好。塔尔还学会了从这种纳米粉末中巩固致密的3YSZ单体，这种纳米粉末具有优异的纯度（化学和相）、高密度的纳米结构颗粒和机械性能。这些材料非常接近于满足ASTM标准F1873，在任何3YSZ假体组件被FDA接受之前必须满足该标准。Tal Materials与现任Signal Medical Co.首席执行官Louis Serafin博士合作，成为美国唯一的陶瓷髋关节和膝关节股骨部件供应商。作为这种关系的第一步，TAL在第一阶段提出建立协议，使YSZ陶瓷具有高度的可重复性，其机械性能优于ASTM F1873。塔尔将制作髋关节，塞拉芬博士将帮助我们通过FDA的认证，并帮助销售这些部件。

DESCRIPTION (provided by applicant): In the field of arthroplasty, roughly 500,000 prosthetic knees and hips are implanted annually in the U.S. This number is expected to increase six fold as "baby boomers" age. Tribological assessment of all materials available for the fabrication of hip implants indicates that ball components fabricated of partially stabilized (toughened) tetragonal zirconia (zirconia doped with 3 mol % yttria, 3YSZ) offer superior wear against polyethylene cups. These in turn offer superior life expectancy for the prosthetic joint in vivo compared with every other material examined. The ceramic hip joint market in the U.S. has always been dominated by European manufacturers. Recently, there have been sufficient failures of European manufactured hip components that the FDA forced a recall of all zirconia-based joints with no replacements forthcoming. Biopro, a Port Huron, MI company co-founded by Dr. Louis Serafin was the only FDA certified U.S. supplier of toughened zirconia hip joints in the U.S. but no longer produces them. Tal Materials has learned to produce large quantities of very high quality nanosized 3YSZ powders using controlled energetic precursor technology (CONCEPT). These nanopowders offer the potential to produce toughened zirconia hip joints with even better properties than the original produced materials. Tal has also learned to consolidate dense 3YSZ monoliths from this nanopowder that offer good-to-excellent purity (chemical and phase), high densities with nanostructured grains, and mechanical properties. These materials are very close to satisfying the ASTM standard F1873 that must be met before any 3YSZ prosthetic component is acceptable to the FDA. Tal Materials has teamed with Dr. Louis Serafin currently CEO of Signal Medical Co. to become the only U.S. supplier of ceramic hip and eventually knee femoral components. As a first step in this relationship TAL proposes under this Phase I to establish protocols leading to a high degree of reproducibility in YSZ ceramics with mechanical properties superior to ASTM F1873. Tal will make the hips and Dr. Serafin will help us qualify with the FDA and also help market these components.