脉冲电场除安全性和肺部敏感结构附近的特征:临床前和临床病例系列研究研究
David W Hunter1, William Krimsky1, R Ryan Meyerhoff2
1Galvanize Therapeutics, Inc., Redwood City, CA, USA.
脉冲电场 (PEF) 提供了一种新的肺切除方法. 阿里亚PEF系统在猪和人类研究中证明了关键肺结构附近的安全性和有效性,为传统模式提供了有希望的替代方案.
科学领域:
- 生物医学工程 生物医学工程
- 肺部病理学 肺部病理学
- 医疗器械 医疗器械
背景情况:
- 脉冲电场 (PEF) 提供非热,非电离的组织剥离.
- 对于PEF技术的潜力,除了热或辐射方法之外,可以在敏感结构附近切除肺组织.
研究的目的:
- 为了证明阿里亚PEFs在肺部的安全输送.
- 通过穿皮和支气管镜接入,评估PEF在关键肺结构附近的应用.
主要方法:
- 在敏感结构 (多叶膜,隔膜,血管,呼吸道) 附近的猪肺组织中评估Aliya PEF系统.
- 临床表现六个人类受试者与敏感结构相邻的病变,他们接受了阿里亚PEF程序.
- 十二只猪接受了穿皮或内支气管肺切除术,随后进行CT,毛细和组织病理学检查.
主要成果:
- 在动物中没有观察到程序内问题或心电图干扰.
- 总病理学和组织学证实了细胞死亡,细胞外基质被保存,敏感结构没有显著改变.
- 在动物或人类受试者身上没有任何不良事件或安全性/性能问题.
结论:
- PEF技术有效地消去细胞,同时保留细胞外基质,并最大限度地减少周围敏感结构的损伤.
- 阿里亚PEF系统为现有的肺切除方法提供了一个潜在的更安全的替代方案.
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