SBIR Phase I: Improving Orthopedic Implants with a Nano-Engineered Surface Coating

这个小型企业创新研究(SBIR)第一阶段项目的更广泛的影响/商业潜力是提高脊柱和整形外科植入物的临床成功，以保持更多的美国人健康和活跃。我们的重点是提高由聚合物制成的广泛使用的植入材料的性能。作为一种硬塑料，它有利于强度，但不利于与周围组织的结合。结果，很高比例的聚合物植入物松动，因为它们不能很好地与骨骼结合。我们的创新通过研究一种用于聚合物植入物的新型纳米工程表面涂层来扩大对科学和技术的理解。这项提议的结果可能是一种革命性的种植表面，具有快速愈合、良好的整合和降低种植失败的风险。外科医生可以有更高的成功率，并节省手术时间。患者的并发症可能会更少。保险公司可以为手术支付更少的费用。制造商可以提供一种先进的技术。这项新的表面技术将首先应用于脊柱植入物，然后扩展到颅面、创伤、运动医学、髋关节、膝盖和四肢应用。我们的目标是将这项技术推向市场，为每年接受整形手术的数万美国人提供一种无痛、移动的生活方式。拟议的项目旨在开发一种用于治疗脊柱融合的聚合物植入物上的纳米工程表面涂层。其目标是通过提供一种与宿主骨密切相互作用的植入物表面，减少由于抑制骨整合而导致的背部问题愈合。我们计划通过使用先进的材料加工技术在聚合物衬底上创建纳米工程表面来做到这一点(目标1)。接下来，我们将用先进的成像技术验证植入表面是否存在纳米工程结构(目标2)。预期的结果将是一种具有纳米结构的新型表面涂层，该涂层在宏观、微观和纳米层面上具有优越的材料属性。广泛的材料表征将验证该程序。制造方法的成功开发将导致机械测试(目标3)。这种纳米工程表面涂层的新奇之处在于，它依赖于表面本身的特性，利用生物材料科学与宿主骨建立快速而强大的结合，增强骨结合过程。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to improve the clinical success of spinal and orthopedic implants to keep more Americans healthy and active. Our focus is to enhance properties of a widely used implant material made of a polymer. As a hard plastic, it is beneficial for strength but unfavorable for integrating with surrounding tissue. As a result, a high percentage of polymer implants loosen because they do not integrate well with bone. Our innovation expands scientific and technical understanding by investigating a novel nano-engineered surface coating for polymer implants. The outcome of this proposal could be a revolutionary implant surface with rapid healing, sound integration, and lowered risk of implant failures. Surgeons could have higher success rates and save on operating time. Patients could have fewer complications. Insurers could pay less for procedures. Manufacturers could offer a superior technology. This novel surface technology will be applied to spinal implants first and then expanded into craniofacial, trauma, sports medicine, hip, knee, and extremities applications. Our goal is to bring this technology to market to provide the tens of thousands of Americans undergoing orthopedic procedures each year a pain-free, mobile lifestyle. The proposed project aims to develop a nano-engineered surface coating on polymer implants for treating spinal fusions. The goal is to reduce back problem unions due to inhibited osseointegration by presenting an implant surface that intimately interacts with host bone down to the cellular level. We plan to do this by using advanced materials processing techniques for creating nano-engineered surfaces on polymer substrates (Objective 1). Next, we will validate with advanced imaging techniques the presence of the nano-engineered structures on the implant surface (Objective 2). The anticipated outcome will be a novel surface coating with a nanostructure that has superior material attributes on the macro, micro and nano levels. Extensive material characterization will validate the procedure. Successful development of fabrication methods will lead to mechanical testing (Objective 3). The novelty of this nano-engineered surface coating is that it relies on the characteristics of the surface itself to create a rapid and powerful bond with host bone enhancing the bone union process using biomaterial science.