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

该小型企业创新研究（SBIR）第一阶段项目旨在开发适用于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传导性在许多临床应用中引起了兴趣，但常规加工的羟基磷灰石材料受到其差的烧结性和由于差的相纯度和均匀性而缺乏机械强度的限制。Angstrom Medica，Inc.已经优化了其纳米结构羟基磷灰石粉末的烧结性、机械强度和纳米结晶性。纳米晶HAP整料似乎提供上级压缩和弯曲强度以及断裂韧性，并有助于更好的成骨细胞附着、增殖和矿化。本项目将对用于小骨固定的可上市纳米晶HAP骨科针进行早期工艺和产品开发，并在尸体骨模型中对该针进行测试。在接下来的第二阶段项目中，这些纳米结构材料将形成更复杂的几何植入物结构，并用于体内动物模型，通常用于验证骨科植入物以获得FDA批准。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.