Fully Biodegradable Septal Defect Occluder-A Double Umbrella Design

Fully Biodegradable Septal Defect Occluder-A Double Umbrella Design
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DOI:
10.1002/ccd.22735
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发表时间:
2010-11-01
影响因子:
2.3
通讯作者:
Yip, James
Yip, James
中科院分区:
医学3区
文献类型:
--
作者:
Duong-Hong, Duc;Tang, Yong-Dan;Yip, James

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目前用于治疗间隔缺损的经皮装置是由不可降解的金属和合成纤维材料制成的。这些装置并不理想,因为存在装置侵蚀的未来并发症的风险,以及未来经鼻中隔手术的潜在障碍。这种可生物降解的双伞装置是由完全可生物降解的聚合物制成的,其特点是两个圆盘与可伸缩的杆相连。通过开胸手术,通过短鞘将这些装置插入约克夏猪的PFO模型中。在1个月的随访期内获得的透视成像和超声心动图显示,装置位置稳定,无分流。体外降解研究和死后移植证实,在1个月的试验期间,该装置具有良好的完整性和机械强度。此外,在1个月后,这些装置似乎被良好地内皮化。这些结果表明,用新一代可生物降解的PFO封堵器取代现有的不可降解封堵器是可行的。本工作研究并论证了一种完全可生物降解的装置介入治疗卵圆孔未闭(PFO)的可行性,我们称之为“双伞”(DU),因为它的象征性设计。(C)2010年Wiley-Liss公司
Current percutaneous devices for septal defect treatment are made of nondegradable metallic and synthetic fabric materials. These devices are not ideal due to risks of future complications from device erosions and potential obstructed access for future transseptal procedures. The biodegradable double umbrella device was made of fully biodegradable polymers, featured with two discs connected with a stretchable stem. The devices were inserted across the PFO model created on Yorkshire swines through a short sheath by open thoracotomy. Fluoroscopic imaging and echocardiography obtained during the 1-month follow-up study period showed that the devices were in stable position with no shunt. The in-vitro degradation study and post-mortem explantation confirmed that the devices have good integrity and mechanical strength during the 1-month trial. Furthermore, the devices appeared to be well endothelialized after 1 month. These results showed clearly that it is feasible to replace the current nondegradable devices with the new generation biodegradable PFO occluders. This work studied and proved the feasibility of interventional closure of patent foramen ovale (PFO) with a fully biodegradable device, that we call the "double umbrella" (DU) for its symbolic design. (c) 2010 Wiley-Liss, Inc.