SBIR Phase I: High Strength, Surface Porous Devices for Improved Spinal Fusions

这个小型企业创新研究(SBIR)第一阶段项目的更广泛的影响/商业潜力是一种新型的高强度表面多孔层，可以改善非金属矫形植入物的集成，从而产生更好的临床结果。这种对矫形植入物的改进对腰椎融合设备尤其重要，这种设备每年用于缓解超过24万名患者的慢性背部和腿部疼痛。非金属聚合物植入物最常用于腰椎融合术，因为它们与医学成像兼容。然而，这些装置的表面光滑，不能很好地与骨结合，这导致了大约11%到15%的并发症和翻修手术率。拟议的项目将研究高强度表面多孔层用于腰椎融合器的可行性。研究目的是确定表面多孔层的结构对改善骨整合的力学性能和生物响应的影响。这项研究将使用标准的力学测试来确定具有表面多孔层的不同聚合物结构的静态和疲劳性能，并确定表面多孔层本身的机械性能。此外，这项研究将利用细胞研究来确定多孔层结构在改善细胞对种植体表面的骨传导反应方面的效果。最后，具有表层的设备将在生理条件下进行原型和测试。预计该结构对整体力学性能的影响最小，同时显著改善骨传导反应。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is a novel high strength, surface porous layer that can improve integration of non-metal orthopedic implants, resulting in better clinical outcomes. This improvement to orthopedic implants is especially important for lumbar fusion devices, which are used to alleviate chronic back and leg pain in over 240,000 patients annually. Non-metal, polymer implants are most commonly used for lumbar fusions because of their compatibility with medical imaging. However, these devices have smooth surfaces that do not integrate well with bone, which leads to a complication and revision surgery rate of approximately 11 to 15%.The proposed project will investigate the feasibility of the high strength, surface porous layer for use on lumbar fusion cages. The research objectives are to determine the effect the architecture of the surface porous layer has on the mechanical properties and the biological response for improved bone integration. The research will use standard mechanical tests to determine the static and fatigue properties of different polymer constructs with the surface porous layer and to determine the mechanical properties of the surface porous layer itself. Additionally, the research will use cell studies to determine the effect the porous layer architecture has on improving the osteoconductive response of cells to the implant surface. Finally, devices with the surface layer will be prototyped and tested under physiological conditions. It is anticipated that the architecture will have a minimal effect on bulk mechanical properties while significantly improving the osteoconductive response.