Guo Gaoyang, Hu Jinpeng, Wang Fan, Fu Daihua, Luo Rifang, Zhang Fanjun, Hu Cheng, Chen Juan, Pan Xiangbin, Yang Li, Wang Yunbing, Zhang Xingdong
National Engineering Research Center for Biomaterials, Sichuan University, Chengdu, 610064, China.
Shanghai Shape Memory Alloy Co., Ltd, Shanghai, 200940, China.
Biomaterials. 2022 Dec;291:121909. doi: 10.1016/j.biomaterials.2022.121909. Epub 2022 Nov 7.
Degradable heart occluders are a promising replacement for currently clinically used non-degradable ones without concerns about the complications caused by the persistent residue of a foreign implant. However, the inherent mechanical properties of degradable occluders are poor and decline with material degradation, leading to a preference for a long degradation period upon designing a degradable heart occluder. This configuration can lower the risk of occluder dislodgement but reduce the benefits of degradable implants over their non-degradable counterparts due to a longer retention of foreign materials in the human body. Here, we fabricated a fully degradable ventricular septum defect (VSD) occluder consisting of polydioxanone (PDO) fiber and poly-L-lactic acid (PLLA) membrane featuring an auto-locking function. The degradable occluder showed an excellent shape recovery effect after transcatheter delivery and anchored securely to a heart defect as evidenced by in vitro and in vivo experiments. The degradable occluder could warrant robust fixation ability during the first 3-months of implantation within which tissue reconstruction was accomplished and be completely absorbed within 12 months. Benefitting from these merits, the degradable occluder displayed desired occlusion and no complications after being implanted in the VSD sites of canines during a 24-months follow-up. Compared with traditional non-degradable occluders, our degradable occluder could provide a potentially superior approach for rapidly repairing the congenital VSD without interfering with the normal development and physiological function of the heart.
可降解心脏封堵器有望替代目前临床使用的不可降解封堵器,而无需担心外来植入物持续残留所引起的并发症。然而,可降解封堵器的固有机械性能较差,且会随着材料降解而下降,因此在设计可降解心脏封堵器时倾向于较长的降解期。这种设计可以降低封堵器移位的风险,但由于异物在人体内保留时间更长,会减少可降解植入物相对于不可降解植入物的优势。在此,我们制造了一种完全可降解的室间隔缺损(VSD)封堵器,它由聚二氧六环酮(PDO)纤维和具有自动锁定功能的聚-L-乳酸(PLLA)膜组成。经体外和体内实验证明,这种可降解封堵器在经导管输送后显示出优异的形状恢复效果,并能牢固地固定在心脏缺损处。可降解封堵器在植入后的前3个月内可确保强大的固定能力,在此期间完成组织重建,并在12个月内完全吸收。得益于这些优点,在对犬类的VSD部位进行24个月的随访中,可降解封堵器植入后显示出理想的封堵效果且无并发症。与传统的不可降解封堵器相比,我们的可降解封堵器可为快速修复先天性VSD提供一种潜在的更优方法,同时不会干扰心脏的正常发育和生理功能。