一个通过导管的两侧门剪贴带有中央填充剂,用于两侧门吐
Tingchao Zhang1, Weiwei Zhang2, Xianzhang Zhen2
1National Engineering Research Center for Biomaterials and College of Biomedical Engineering, Sichuan University, Chengdu, 610064, China; Hangzhou Valgen Medtech Co, Ltd, Hangzhou, 310052, China.
Biomaterials
|April 5, 2025
概括
一个新的DragonFly跨导管关节带提供了改善的小册子抓住和稳定性关节 regurgitation治疗. 这种设备在研究中显示出有希望的生物相容性和有效的血液动力学.
科学领域:
- 心血管医学 心血管医学
- 生物材料科学 生物材料科学
- 医疗器械 医疗器械
背景情况:
- 横导管边缘到边缘修复 (TEER) 对于 mitrale 排泄,面临的挑战是传单抓取和剪贴脱落.
- 现有的设备需要改进,以更广泛的临床应用和患者适应性.
研究的目的:
- 为了介绍和详细介绍这部新奇的DragonFly跨导管中枢门剪贴.
- 评估其材料组成,设计特征,性能和生物相容性.
主要方法:
- 详细介绍了DragonFly片的构造材料 (-合金,不钢,-合金,聚乙烯四,尼醇) 和设计 (可调臂,抓柄,中央填充器).
- 机械测试评估了疲劳寿命 (>4亿次) 和抓取力.
- 生物相容性通过体外,体内和大型动物的研究来评估,遵循ISO 10993标准.
主要成果:
- 龙飞片段展示了强大的传单抓取,防止在各种角度和解剖学上脱离.
- 尼丁醇中心填充剂提供了出色的压缩性和形状恢复.
- 机械和生物相容性评估证实了设备的安全性和耐用性.
- 观察到成功地创建了一个稳定的双孔结构,没有有害的血液动力学影响.
结论:
- 龙飞门片代表了跨导管 mitra 门修复的重大进步.
- 它的设计提供了增强的掌握稳定性和适应性,解决了当前TEER设备的局限性.
- 这种新型设备扩大了对关节疾病患者的治疗选择,特别是高危人群.
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