SBIR Phase I: Manufacturing and Testing of Nanocrystalline Hydroxyapatite Orthopedic Implants

这个小企业创新研究（SBIR）第一阶段项目建议开发适合制造纳米晶羟基磷灰石骨科植入物的成型和烧结工艺。尽管羟基磷灰石的骨导电性在许多临床应用中引起了人们的兴趣，但传统加工的羟基磷灰石材料由于相纯度和均匀性差，其烧结性能差，缺乏机械强度，因此受到限制。埃斯特姆医药公司对其羟基磷灰石粉末的纳米结构进行了优化，以提高烧结性能、机械强度和纳米结晶度。纳米晶HAP单体具有优异的抗压和弯曲强度以及断裂韧性，有助于更好的成骨细胞附着、增殖和矿化。该项目将进行用于小骨固定的可销售的纳米晶HAP骨科针的早期工艺和产品开发，并在尸体骨模型中对该针进行测试。在接下来的二期项目中，这些纳米结构材料将被制成几何形状更复杂的植入物结构，并用于体内动物模型，通常用于验证FDA批准的骨科植入物。该项目的商业应用是在骨科植入物领域。

This Small Business Innovation Research (SBIR)Phase I project proposes to develop forming and sintering processes suitable for the manufacture of nanocrystalline hydroxyapatite orthopedic implants. Though hydroxyapatite's osteoconductivity has generated interest in many clinical applications, conventionally processed hydroxyapatite materials have been limited by their poor sinterability and lack of mechanical strength attributed to poor phase purity and homogeneity. Angstrom Medica, Inc. has optimized its nanostructure hydroxyapatite powders for sinterability, mechanical strength and nanocrystallinity. The nanocrystalline HAP monoliths appear to provide superior compressive and bending strengths as well as fracture toughness, and contribute to better osteoblast attachment, proliferation and mineralization. This project will conduct the early process and product development of a marketable nanocrystalline HAP orthopedic pin for small bone fixation and the testing of this pin in a cadaver bone model. In the follow on Phase II project, these nanostructured materials will be formed into more geometrically complex implants constructs and utilized in in vivo animal models commonly employed to validate orthopedic implants for FDA approval.The commercial application of this project is in the area of orthopedic implants.