SBIR Phase I: Degradation-Deformation Relationships in Novel Controlled-Dissolution Magnesium Alloys

这个小企业创新研究（SBIR）第一阶段项目旨在通过发展微观结构、降解行为和机械行为之间的结构-性能关系，制备一种新型的含有碱土金属的可生物降解镁合金，用于商业化。镁具有接近传统金属的机械性能和聚合物的生物可吸收性，作为骨科植入物，镁具有超越这两类材料的潜力。这些镁合金可以在500亿美元的植入物市场中为患者提供广泛的应用，并且特别适合在5亿美元的缝合锚定市场中竞争。除了将特定合金推向商业化之外，第一阶段将对微观结构如何影响降解和机械性能产生新的理解，为新兴的镁植入物领域增加关键数据。在不久的将来，这些医疗设备将为患者提供更好的治疗效果，同时成为植入物市场的主导力量。该项目的智力价值来自于微观结构与降解和力学行为之间的结构-性能关系的发展。充分的机械完整性和适当的降解率是生物可吸收机械植入物成功的关键，这些关系必须在广泛的体内试验之前建立。研究将包括一套微观结构修饰、体外降解测试和整体力学测试。考虑的关键因素是晶粒尺寸、织构、沉淀形态和体积分数、降解测试、压缩和拉伸测试。一旦了解了这些变量之间的关系，就可以针对特定患者设计出优化的、甚至量身定制的植入物。

This Small Business Innovation Research (SBIR) Phase I project aims to prepare a novel biodegradable magnesium alloy containing alkaline earth metals for commercialization by developing structure-property relationships between microstructure, degradation behavior, and mechanical behavior. With mechanical properties close to that of a traditional metal and the bioabsorbability of a polymer, magnesium has the potential to outcompete both classes of material as an orthopedic implant. These magnesium alloys can offer benefits to patients across a wide range of applications in the $50 billion implant market, and are particularly well suited to compete in the $500 million suture anchor market. Beyond advancing a particular alloy forward towards commercialization, this Phase I will result in a new understanding of how microstructure impacts degradation and mechanical properties, adding crucial data to the fledgling field of magnesium implants. In the near future, these medical devices will offer improved outcomes to patients, while becoming a dominant force in the implant market. The intellectual merit of this project is derived from the development of structure-property relationships between microstructure and both degradation and mechanical behavior. Sufficient mechanical integrity and an appropriate degradation rate are critical to the success of bioabsorbable mechanical implant, and these relationships must be established prior to broad in-vivo testing. The studies will consist of a suite of microstructural modification, in-vitro degradation testing, and bulk mechanical testing. The critical factors being considered are grain size, texture, precipitate morphology and volume fraction, degradation testing, compression, and tension testing. Once relationships between these variables are known, implants can be designed with optimized, and even tailored, properties for a given patient.