基于抗菌性纳米介孔表面修饰的二段可调解剖型脊柱修复系统的构建与实验研究

Repair and reconstruction of bone tissues has been an important problem in clinical treatment and a hot area of research. The presence of spinal cord and intervertebral discs makes it difficult to implant repair materials during spinal surgeries. And, the efficiency of ossification is relatively low and susceptible to infection. The applicant intends to modify the n-H A/PA66 nano-artificial bone material, which has been widely used and accepted in the clinical setting, by electrostatic spinning technology. After covering the surface with a nano-porous fiber layer, the modified material will have the ability to promote cell adhesion and bonding of the material-tissue interface. Moreover, quaternary ammonium compounds with good antibacterial effects will be integrated into the nano-material, which will minimize the solubility of quaternary ammonium salts to achieve long-term antibacterial effect and reduce the risk of infection. Then, anatomical two-segment vertebral support body with adjustable length will be designed based on the point cloud database which is built by Mimics 10.0 and Imageware Vl2.1 with image data of vertebral bodies acquired by CT scanning, to completely solve clinical problems such as implantation difficulties, high incidences of collapse, low rate of fusion and high risk of spinal cord injury. Animal experiments will be carried out to assess the convenience of the operation and the effect of bone integration, and explore new approaches to solve the clinical problem of vertebral body defect.

骨组织的修复重建是临床治疗的难题和研究热点。在脊柱外科领域，脊髓、椎间盘等结构的存在导致手术过程中修复材料植入困难，成骨效率低，容易感染。申请者拟将近年来在临床中使用并取得良好效果的n-H A/PA66纳米人工骨材料进行改性，通过静电纺丝技术将材料表面覆盖纳米多孔纤维薄层，促进细胞的黏附，更好的实现材料组织界面结合。并将具有优良抗菌抑菌效果的季铵化合物编织其内，最大程度的限制季铵盐的水溶性，达到长效的抗菌抑菌效果，降低感染风险；实验还将通过CT扫描获取椎体的图像数据，利用 Mimics10.0、 Imageware Vl2.1构建点云数据库，设计解剖型的两段式椎体支撑体模型，使其长短可调，能够紧密贴合椎体，彻底解决脊柱外科临床使用时植入困难、塌陷率高，融合率低，损伤脊髓风险大,容易感染等问题。并通过动物实验检测其操作的方便性以及骨整合的效果，为更好的解决椎体缺损的临床难题探索新的方法。

骨组织的修复重建是临床治疗的难题和研究热点。在脊柱外科领域，脊髓、椎间盘等结构的存在导致手术过程中修复材料植入困难，成骨效率低，容易感染。此次研究中我们制备出具有抗菌功能的纳米纤维介孔薄层，并表征其生物相容性和抗菌活性。通过基础实验初步证实其具有促进骨界面整合和抑菌效果。我们通过测量中青年患者的腰椎CT数据，设计出了高度可调，两端接触面符合椎体终板解剖结构的新型人工假体。利用有限元分析的方法证实了该新型人工假体与钛网和可调式人工椎体相比具有相似的生物力学性能，能够维持脊柱固定节段的稳定性。与钛网和可调式人工椎体相比，该新型假体具有加大的终板接触面积，因此能够减少假体与终板接触面的应力集中，避免椎体塌陷的风险。我们通过动物实验证实了该假体能够维持固定节段脊柱稳定性。通过以上的研究结果表明，该新型人工假体具有良好的生物力学性能，并且通过表面改性干预，能够起到促进骨界面整合和抑菌作用，具有较好的临床应用价值。

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