慢性植入心脏的生命终端生物相容性评估
Eric K Long1, Joseph F Hassler1, David M Saylor2
1Global Technology and Innovation, Medtronic Inc, Minneapolis, Minnesota, USA.
Journal of biomedical materials research. Part A
|May 23, 2025
概括
随着时间的推移,心脏线索的生物相容性保持稳定. 对人体植入线索的可提取分析显示,没有新物种形成,现有的物种保持不变或减少,支持长期安全.
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
- 分析化学 分析化学
背景情况:
- 医疗器械的生物相容性在整个生命周期中至关重要.
- 目前的评估通常评估新设备,而不是长期变化.
- 长期植入设备,如心脏导线,需要了解生命周期材料的行为.
研究的目的:
- 为了研究随着时间的推移,在人体内植入的心脏线索中可提取物种的变化.
- 评估植入时间对心脏导电的化学特征的影响.
- 评估长期植入器械生物相容性的稳定性.
主要方法:
- 从人体植入的心脏导线 (3-130个月) 中提取的分析.
- 使用液体色谱与质谱学 (LC-MS) 结合用于识别和量化.
- 进行了详尽的提取,以确定所有移动物种.
主要成果:
- 在超过十年的植入时间内,没有形成新的可提取物种.
- 移动物种的数量在植入期内保持不变或减少.
- 聚氨寡合物保持不变;抗氧化剂添加剂显示扩散释放,而不是反应性消耗.
结论:
- 心脏导管中移动物种的化学特征在植入的生命周期内不会发生变化.
- 耐用心脏导线的生物相容性随着时间的推移而保持.
- 从新设备中完全释放可提取物的假设与体内释放率相比过于保守.
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