3D打印聚乳酸材质骨科手术导板灭菌效果验证

Sterilization effect verification of 3D-printed polylactic acid guide plate for orthopedic surgery

  • 摘要:
    目的 探讨不同灭菌方法对3D打印聚乳酸(PLA)材质骨科手术导板灭菌效果的影响, 并分析其灭菌后的物理性能、微生物污染情况、结构性能及生物相容性。
    方法 使用3D打印技术制备PLA材质骨科手术导板, 并分为空白组、过氧化氢等离子体灭菌组、环氧乙烷灭菌组和压力蒸汽灭菌组。通过测量灭菌前后手术导板的体积、重量变化、微生物检测, 使用激光扫描共聚焦显微镜观察结构变化, 进行细胞共培养评估生物相容性, 评估不同灭菌方法的效果。
    结果 3种灭菌方法对PLA材质手术导板的体积和重量均无显著性影响。微生物检测显示, 3种灭菌方式均能有效杀灭细菌, 菌培养均为阴性。激光共聚焦扫描显微镜观察发现, 灭菌处理对手术导板的微观结构造成一定变化, 但高温灭菌对导板边缘的形变较为明显。细胞共培养结果显示, 3种灭菌方式处理后的手术导板细胞毒性合格, 对细胞增殖基本无影响。
    结论 3种灭菌方式对手术导板均有微观结构改变, 其中压力蒸汽灭菌对导板结构有明显形变, 直接影响其在手术过程中精准定位相互空间距离、成角关系及方向。过氧化氢等离子体灭菌未造成明显形变, 环氧乙烷灭菌在保证PLA手术导板灭菌效果的同时, 对材料性能和结构稳定性影响最小。

     

    Abstract:
    OBJECTIVE To investigate the effects of different sterilization methods on 3D-printed polylactic acid (PLA) guide plates for orthopedic surgery, and to analyze their physical properties, microbial contamination, structural performance and biocompatibility after sterilization.
    METHODS PLA guide plates for orthopedic surgery were prepared with 3D printing technology and divided into a blank group, a hydrogen peroxide plasma sterilization group, an ethylene oxide sterilization group and a pressure steam sterilization group. Before and after sterilization, the changes in volume and weight of the surgical guide plates were measured, microbial detection was conducted, structural changes were observed with a laser scanning confocal microscope, and cell co-culture was conducted to evaluate biocompatibility, thereby the effects of different sterilization methods were assessed.
    RESULTS The three sterilization methods had no significant effect on the volume and weight of PLA surgical guide plates. Microbial detection showed that all three sterilization methods were effective in killing bacteria, and bacterial cultures were negative. Laser confocal scanning microscopy revealed that sterilization treatment caused certain changes to the microstructure of the surgical guide plates, but high-temperature sterilization had a more pronounced effect on the deformation of the guide plate edges. Cell co-culture results indicated that the surgical guide plates treated with the three sterilization methods exhibited acceptable cytotoxicity and had little effect on cell proliferation.
    CONCLUSIONS All three sterilization methods cause microstructural changes to the surgical guide plate. Among them, pressure steam sterilization significantly deforms the structure of the guide plate, directly affecting its precise positioning of mutual spatial distances, angular relationships and orientation during surgery. Although hydrogen peroxide plasma sterilization does not cause significant deformation, ethylene oxide sterilization has the least impact on material properties and structural stability while ensuring the sterilization effect of PLA surgical guide plates.

     

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