Nanostructured Zirconia Ceramics for Joint Prosthetics

用于关节假体的纳米结构氧化锆陶瓷

• 批准号: 6737043
• 负责人: ANTHONY C SUTORIK
• 金额: $ 9.94万
• 依托单位: TAL MATERIALS, INC.
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-02-01 至 2004-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6737043
• 关键词: arthroplasty; biomaterial development /preparation; biomechanics; ceramics; hip prosthesis; joint prosthesis; medical implant science; nanomedicine; zirconium

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.

描述（由申请人提供）：在关节成形术领域，美国每年大约植入50万个假体膝关节和髋关节。随着“婴儿潮一代”年龄的增长，这一数字预计将增加六倍。对可用于制造髋关节植入物的所有材料进行的摩擦学评估表明，由部分稳定（增韧）四氧化锆（掺杂3 mol %氧化钇的氧化锆，3YSZ）制成的球头部件与聚乙烯髋臼杯相比具有上级磨损。与其他材料相比，这些材料在体内为假体关节提供了上级预期寿命。美国的陶瓷髋关节市场一直由欧洲制造商主导。最近，欧洲制造的髋关节组件出现了足够的故障，FDA强制召回了所有氧化锆关节，并且没有更换。Biopro是密歇根州休伦港的一家公司，由Louis Serafin博士共同创立，是美国唯一一家获得FDA认证的增韧氧化锆髋关节供应商，但已不再生产。Tal Materials已经学会使用受控高能前体技术（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具有比原始生产材料更好性能的增韧氧化锆髋关节的潜力。Tal还学会了从这种纳米粉末中固结致密的3YSZ单块，这种纳米粉末提供良好到优异的纯度（化学和相），具有纳米结构颗粒的高密度和机械性能。这些材料非常接近于满足ASTM标准F1873，在FDA接受任何3YSZ假体组件之前必须满足该标准。Tal Materials与Signal Medical Co.现任首席执行官Louis Serafin博士合作，成为美国唯一的陶瓷髋关节和最终膝关节股骨部件供应商。作为这种关系的第一步，TAL建议在第一阶段建立方案，以实现机械性能上级优于ASTM F1873的YSZ陶瓷的高度再现性。塔尔将制造髋关节，塞拉芬博士将帮助我们获得FDA的资格，并帮助销售这些组件。