ERC - Small Business: Biological and Biomechanical Assessment of Magnesium as a Possible Bioresorbable Material for Intervertebral Spinal Fusion

这项工作是北卡罗来纳农工州立大学金属生物材料革命化工程研究中心(人民币)、其合作机构(匹兹堡大学、辛辛那提大学、汉诺威医学院、工业界、创新者以及州和地方政府合作伙伴)与北卡罗来纳州ERC小型企业创新合作伙伴OrthoKinetic Technologies LLC和同样位于北卡罗来纳州的技术加速器东南科技创新公司之间的合作。ERC成立于2008年。这项建议专门针对ERC-人民币开发的可降解MG系统，作为一种可能的脊柱间融合应用材料。智能价值这项努力的目的是通过为颅面、牙科、矫形、心血管、胸部和神经干预创造“智能”植入物来改变当前的内科和外科治疗。ERC将开发可生物降解的系统，将基于镁的新型生物工程材料与可以控制植入物完整性的微型传感器设备相结合。ERC将开发可生物降解的系统，将基于镁的新型生物工程材料与可以控制植入物完整性的微型传感器设备相结合。与当今使用的植入物相比，可生物降解系统提供了显著的治疗优势。这样的系统将能够生长并适应人体，并最终在不再需要时溶解。这项研究的第一阶段是合成生物力学稳定的镁合金，可能用作脊柱融合器。这项工作探索了使用合金元素来增加耐腐蚀性，增加韧性，并促进骨整合。这项研究的第二阶段将对使用镁及其合金作为生物可吸收材料的腰椎融合器进行全面的力学评估。第三阶段是腐蚀评估或再吸收过程分析。更广泛的影响脊柱手术通常是脊柱稳定和缓解疼痛的最终选择。植骨融合配合脊柱内固定系统是一种用于稳定脊柱的传统外科技术。这种植骨和脊柱内固定结构的最终目标是创造一个平衡的环境，在这种环境中，脊柱内固定最初作为承载元件发挥作用，在植骨和愈合的早期不稳定阶段固定融合节段。到2016年，美国脊柱植入物市场预计将超过80亿美元，而微创外科(MIS)脊柱植入物市场预计将达到30亿美元以上。教育和外展计划是通过正在进行的ERC方案，通过针对中小学生、社区大学生及其教师、辅导员、家长和管理人员的基础广泛的外展方案实现的。这些活动包括非正式教育、家长见面会。这项工作满足了对新型生物相容性生物材料的需求，该材料能够在吸收过程中吸收并允许骨蠕动替代，同时保持机械结构的完整性，作为脊柱融合的理想替代方案。

This effort is a collaboration between the Engineering Research Center for Revolutionizing Metallic Biomaterials (RMB) at the North Carolina A&T State University, its partner institutions (the University of Pittsburgh, the University of Cincinnati, Hannover Medical School, industrial, innovator, and state and local government partners) and NC-based ERC small business innovation partner OrthoKinetic Technologies LLC and Southeast TechInventures, Inc., a technology accelerator also located in NC. The ERC was started in 2008. This proposal, specifically addresses the degradable Mg system developed at the ERC-RMB as a possible material for intervertebral spinal fusion application.Intellectual MeritThe purpose of this effort is to transform current medical and surgical treatments by creating "smart" implants for craniofacial, dental, orthopedic, cardiovascular, thoracic and neural interventions. The ERC will develop biodegradable systems that combine novel bioengineered materials based on magnesium with miniature sensor devices that can control the integrity of implants. The ERC will develop biodegradable systems that combine novel bioengineered materials based on magnesium with miniature sensor devices that can control the integrity of implants. Biodegradable systems offer significant therapeutic advantages over implants used today. Such systems will be able to grow and adapt to the human body and eventually dissolve when no longer needed. The first phase of this research is to synthesize magnesium alloys that are biomechanically stable for possible use as a spinal fusion cage. The effort explores the use of alloying elements to increase corrosion resistance, increase toughness, and promote osteointegration. The second phase of this study will provide a comprehensive mechanical assessment of a spinal fusion cage for the lumbar spine using magnesium and its alloys as the bioresorbable materials. The third phase will be corrosion assessment or resorption process analysis. Broader Impact Spinal surgery is often a final alternative to spinal stabilization and relief of pain. Bone graft fusion with accompanying spinal instrumentation systems is a conventional surgical technique used to stabilize the spine. The eventual goal of this bone graft and spinal instrumentation construct is to create a balanced environment where the spinal instrumentation is used to initially function as the load bearing element that immobilizes the fusion segment during the early unstable stages of bone grafting and healing. The U.S. market for spinal implants is estimated to exceed $8 billion by 2016, while the minimally invasive surgical (MIS) spinal implant market is estimated to reach over $3 billion. The education and outreach plans are achieved through the ongoing ERC programs through broad-based outreach programs targeted at elementary and secondary school students, community college students and their teachers, counselors, parents and administrators. These include informal education, parent information sessions. This effort addresses the need for a novel biocompatible biomaterial capable of resorbing and allowing creep substitution by bone during resorption, while maintaining mechanical structural integrity, as an ideal alternative to spinal fusion.