SBIR Phase I: Osteoconduction Determination of Mineral Coated Silicon Dioxide Nanosprings

这个小企业创新研究第一阶段项目解决了骨整合的失败，即整形外科设备与骨之间缺乏粘合。植入物的失败率高得令人无法接受(8-20%)。翻修手术的主要驱动力是植入物的无菌性松动，这种松动发生在纳米级。这可能对患者非常有害，因为修改后的植入物有更高的并发症发生率。研究目标是开发一种骨科植入涂层，模拟愈合编织骨的支架和矿物结构。涂层纳米弹簧是一种合成的胶原纳米生物材料，它模仿骨骼的支架成分。这项提议旨在在纳米弹簧上开发一层矿物层，以制造合成编织骨。纳米弹簧可以在整形外科设备上生长。金属合金涂层纳米弹簧具有良好的人体耐受性，可提高骨沉积速度，但手术费用较高。所提议的涂层所使用的矿物价格低廉，但缺乏骨整合所需的支架效果。将这两种合成生物材料结合起来，将为促进骨整合提供必要的经济支架。该项目对骨传导生物材料市场的广泛影响/商业潜力是巨大的。整形外科市场是一个价值数十亿美元的行业，随着婴儿潮一代人口的老龄化，这一行业将会增加。这项技术既可以用于动物设备，也可以用于人类设备，如牙科植入物、假体和关节置换。潜在的商业化选择是与现有的整形外科设备制造商合作开发这种附加涂层，或者直接销售到动物市场，然后在FDA允许的情况下销售到人类市场。包覆的纳米弹簧能够极大地提高骨沉积的速度和硬度。据推测，种植体周围的这种增加可以对改善患者S的生活质量产生重大的临床影响，并产生经济效益。这项新技术可以为生物和其他硬科学领域的科学家提供就业机会。纳米弹簧是骨传导研究的理想基础。这种合成的胶原蛋白允许在纳米级别上研究不同的涂层材料。因此，为骨整合过程提供了材料和生物学方面的见解。

This Small Business Innovation Research Phase 1 project addresses the failure of osseointegration, the lack of bonding between an orthopedic device and bone. Failure of the implant does occur with an unacceptably high rate (8-20%). The main driver for revision surgery is aseptic loosening of the implant, which occurs at a nanoscale. This can be very detrimental to the patient since the revised implants have higher complication rates. The research objective is to develop an orthopedic implant coating that mimics both the scaffolding and mineral structure of healing woven bone. Coated nanosprings, a synthetic collagen nanobiomaterial, mimics the scaffolding component of bone. This proposal is directed at developing a mineral layer on the nanosprings to make synthetic woven bone. Nanosprings can be grown on orthopedic devices. Metal alloy coated nanosprings are well tolerated by the body and increase the bone deposition rate, but the procedure is expensive. The mineral used for the proposed coating is inexpensive but lacks the scaffolding effects needed for bone integration. Combining these two synthetic biomaterials would provide the necessary economical scaffolding to facilitate osseointegration.The broader impact/commercial potential of this project to the osteoconductive biomaterial market is vast. The orthopedic market is a multi-billion dollar industry, which will increase as the baby boomer population ages. This technology can be employed in both animal and human devices, such as dental implants, prosthetics, and joint replacements. The potential commercialization options are partnering with an existing orthopedic device manufacturer for this add-on coating, or direct sales to the animal market, and then to the human market as the FDA allows. The coated nanosprings have the ability to greatly increase the rate and hardness of bone deposition. It is hypothesized that this increase around implants can have a significant clinical impact to improve the quality of patient?s lives as well as an economical benefit. This new technology can provide employment for scientists in both biologic and other hard science fields. The nanosprings are an ideal foundation for osteoconductive research. This synthetic collagen allows different coating material to be studied at a nanoscale level. Thus, providing both materials and biologic insight to the osseointegration process.