植入物表征方面的进展:对生物相容性评估的化学,物理和生物方法的全面概述
Kevin Dzobo1, Nonhlanhla Khumalo1, Vanessa Zamora Mora2
1Medical Research Council-SA Wound Healing Unit, Hair and Skin Research Laboratory, Division of Dermatology, Department of Medicine, Groote Schuur Hospital, Faculty of Health Sciences, University of Cape Town, Anzio Road, Observatory, Cape Town 7925, South Africa.
Bioengineering (Basel, Switzerland)
|December 30, 2025
概括
目前的植入物测试缺乏特异性. 本次审查提出了一个应用特定的框架,整合化学,物理和生物测试,以提高患者安全和设备创新.
科学领域:
- 生物材料科学 生物材料科学
- 医疗设备工程 医疗设备工程
- 监管科学 监管科学
背景情况:
- 植入物在乳房增大等医疗应用中很普遍,但长期的安全性和生物相容性仍然令人担忧.
- 现有的ISO 10993医疗器械测试协议经常使用一种适合所有人的方法,这可能会限制它们对特定植入物类型的相关性.
研究的目的:
- 批判性地评估目前的化学,物理和生物测试方法,以测试植入物生物相容性.
- 为评估植入物安全性和性能提出一个改进的,特定于应用的框架.
主要方法:
- 对聚合物特性化学分析 (FTIR,拉曼,NMR) 的审查.
- 对表面评估的物理方法 (SEM,AFM,接触角度) 的评估.
- 分析生物测试 (体外/体内测试) 和机械测试,以预测宿主反应和耐久性.
主要成果:
- 当前的测试协议在量身定制评估以适应特定的植入物特征和暴露时间方面存在局限性.
- 化学,物理和机械测试为质量控制和预测体内性能提供了关键数据.
- 像器官芯片和机器学习这样的新兴技术为更具预测性的评估提供了潜力.
结论:
- 需要一种特定于应用的模块化测试策略,整合多种方法和临床数据.
- 这种方法可以提高患者安全,监管明确性和植入物开发方面的创新.
- 量身定制的生物相容性评估对于将临床前数据与实际临床结果相结合至关重要.
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