增材制造和杀菌对聚 (p-Dioxanone) 在肠道环境中的短期应用的影响
Stefanie Ficht1, Lukas Schübel2, Diana M Rojas-González1
1Technical University of Munich, TUM School of Engineering and Design, Department of Mechanical Engineering, Chair of Medical Materials and Implants, Munich Institute of Biomedical Engineering (MIBE), Munich, Germany.
Journal of biomedical materials research. Part A
|July 5, 2025
概括
使用化丝制造 (FFF) 进行聚二氧 (PPDO) 的增材制造是可行的. 等离子灭菌保留PPDO结构和机械性能,与玛辐射不同,确保短期应用的植入物功能.
科学领域:
- 生物材料工程 生物材料工程
- 聚合物科学 聚合物科学
- 医疗设备制造业 医疗设备制造业
背景情况:
- 针对患者的可生物降解聚合物植入物的增材制造 (AM) 正在增长,特别是在护理点生产.
- 增强剂工艺和灭菌对聚合物结构,机械性能和降解的影响对于植入物功能至关重要,但研究不足.
研究的目的:
- 研究化丝制造 (FFF) 和两种灭菌方法 (H2O2等离子体,玛辐射) 对聚二氧化 (PPDO) 结构和降解的影响.
- 评估通过FFF制造的PPDO植入物的适合性,用于需要稳定的机械性能的短期应用.
主要方法:
- 聚二松) (PPDO) 使用化丝制造 (FFF) 进行处理.
- 用H2O2等离子体或马辐射灭菌样品.
- 在索伦森的酸盐缓冲器 (pH 6.47) 中评估了28天的降解,监测了分子量,固有的粘度和抗拉强度.
主要成果:
- 对PPDO的FFF加工没有改变其结构或细胞相容性.
- 血灭菌 (PS) 没有显著变化;玛灭菌 (GS) 显著降低了分子量和固有的粘度.
- 与非消毒 (NS) 和PS样品相比,GS样品在降解过程中分子量,固有的粘度和抗拉强度下降得更快.
- 在28天内,在任何组中都没有观察到显著的质量损失.
结论:
- 血灭菌后的FFF是生产短期使用PPDO医疗器械的可靠方法.
- 血灭菌保护PPDO的机械完整性,这对于降解前的早期植入阶段至关重要.
- 在测试剂量下,玛杀菌对机械性质的损害太快,对于植入后最初几周需要稳定性的应用而言.
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