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绿色非异氰酸酯聚氨酯人工心脏瓣膜的设计、制造和测试。

Design, manufacturing and testing of a green non-isocyanate polyurethane prosthetic heart valve.

机构信息

Laboratory of Cardiology, GIGA-Cardiovascular Sciences, University of Liège, Avenue de l'Hôpital 11, B34, 4000 Liège, Belgium.

Center for Education and Research on Macromolecules (CERM), CESAM Research Unit, Department of Chemistry, University of Liège, Allée du 6 août 13, B6a, 4000 Liège, Belgium.

出版信息

Biomater Sci. 2024 Apr 16;12(8):2149-2164. doi: 10.1039/d3bm01911j.

DOI:10.1039/d3bm01911j
PMID:38487997
Abstract

The sole effective treatment for most patients with heart valve disease is valve replacement by implantation of mechanical or biological prostheses. However, mechanical valves represent high risk of thromboembolism, and biological prostheses are prone to early degeneration. In this work, we aim to determine the potential of novel environmentally-friendly non-isocyanate polyurethanes (NIPUs) for manufacturing synthetic prosthetic heart valves. Polyhydroxyurethane (PHU) NIPUs are synthesized an isocyanate-free route, tested , and used to produce aortic valves. PHU elastomers reinforced with a polyester mesh show mechanical properties similar to native valve leaflets. These NIPUs do not cause hemolysis. Interestingly, both platelet adhesion and contact activation-induced coagulation are strongly reduced on NIPU surfaces, indicating low thrombogenicity. Fibroblasts and endothelial cells maintain normal growth and shape after indirect contact with NIPUs. Fluid-structure interaction (FSI) allows modeling of the ideal valve design, with minimal shear stress on the leaflets. Injection-molded valves are tested in a pulse duplicator and show ISO-compliant hydrodynamic performance, comparable to clinically-used bioprostheses. Poly(tetrahydrofuran) (PTHF)-NIPU patches do not show any evidence of calcification over a period of 8 weeks. NIPUs are promising sustainable biomaterials for the manufacturing of improved prosthetic valves with low thrombogenicity.

摘要

对于大多数患有心脏瓣膜疾病的患者来说,最有效的治疗方法是通过植入机械或生物假体来置换瓣膜。然而,机械瓣膜存在高血栓栓塞风险,而生物假体容易早期退化。在这项工作中,我们旨在确定新型环保型无异氰酸酯聚氨酯(NIPU)在制造合成心脏瓣膜假体方面的潜力。通过无异氰酸酯途径合成聚己内酯型 NIPU,对其进行测试,并用于生产主动脉瓣。用聚酯网增强的聚己内酯型 NIPU 弹性体具有与天然瓣叶相似的机械性能。这些 NIPU 不会引起溶血。有趣的是,NIPU 表面上的血小板黏附和接触激活诱导的凝血均明显减少,表明其血栓形成性低。成纤维细胞和内皮细胞与 NIPU 间接接触后仍能保持正常的生长和形态。流体-结构相互作用(FSI)允许对理想瓣膜设计进行建模,使瓣叶上的剪切应力最小化。在脉动流复制器中对注塑成型的瓣膜进行测试,结果表明其具有符合 ISO 标准的流体动力学性能,与临床使用的生物假体相当。在 8 周的时间内,聚四氢呋喃(PTHF)-NIPU 补片没有任何钙化的迹象。NIPU 是一种很有前途的可持续生物材料,可用于制造具有低血栓形成性的改良型假体瓣膜。

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