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新型复合心脏瓣膜假体的结构稳定性 - 疲劳与磨损性能。

Structural stability of novel composite heart valve prostheses - Fatigue and wear performance.

机构信息

National Key Laboratory of Science and Technology on Advanced Composites in Special Environments, Harbin Institute of Technology, Harbin, Heilongjiang, 150008, PR China.

National Key Laboratory of Science and Technology on Advanced Composites in Special Environments, Harbin Institute of Technology, Harbin, Heilongjiang, 150008, PR China.

出版信息

Biomed Pharmacother. 2021 Apr;136:111288. doi: 10.1016/j.biopha.2021.111288. Epub 2021 Jan 22.

DOI:10.1016/j.biopha.2021.111288
PMID:33493869
Abstract

Heart valve replacement is a very effective method to treat severe valvular stenosis or valvular insufficiency. The valve can be divided into the mechanical valve and biological valve according to the main materials of the valve leaflets. The former has good durability, but the patients need to take anticoagulants all their lives, otherwise, thrombosis will occur; the latter has good blood compatibility, and only 3-6 months of postoperative anticoagulation is required, but its durability is lower than the former. Compared with a traditional valve used materials, the fabric composite valve leaflets have both mechanical valve and biological valve advantages, i.e. it can have both good blood compatibility and excellent fatigue resistance. This material is comprised of the internal fabric layer and bilateral external polyurethane layers jointed with adhesive, and it can adjust the flexibility, wear-resistance and fatigue resistance of the valve leaflet through adjusting the thickness of the outer polyurethane protective layer, the weaving method, the fiber diameter and the surface density of the inner ultra-high molecular weight polyethylene (UHMWPE) fabric. In this article, we tested the long-term durability of a fabric composite with its property close to the valve leaflet made of bovine pericardium, to evaluate the material performance loss under long-term fatigue and the wear degree of this material with different polyurethane layer thicknesses. As many as two hundred million cycles of fatigue test and the hydrodynamic performance test before and after the fatigue test proved that the material could withstand a service life of at least five years without structural failure or functional degradation. According to the SEM images after the experiment, it can be predicted that this material can achieve a longer fatigue life.

摘要

心脏瓣膜置换术是治疗严重瓣膜狭窄或瓣膜关闭不全的非常有效的方法。根据瓣膜瓣叶的主要材料,瓣膜可分为机械瓣和生物瓣。前者耐久性好,但患者需终身服用抗凝剂,否则会发生血栓;后者血液相容性好,术后仅需抗凝 3-6 个月,但耐久性低于前者。与传统使用的材料相比,织物复合材料瓣叶具有机械瓣和生物瓣的优点,即具有良好的血液相容性和优异的抗疲劳性。这种材料由内部织物层和两侧的聚氨酯外层通过粘合剂连接而成,可以通过调节外聚氨酯保护层的厚度、编织方法、纤维直径和内部超高分子量聚乙烯(UHMWPE)织物的表面密度来调整瓣叶的柔韧性、耐磨性和抗疲劳性。在本文中,我们测试了一种与牛心包制成的瓣叶性能接近的织物复合材料的长期耐久性,以评估该材料在长期疲劳下的性能损失以及不同聚氨酯层厚度下的磨损程度。多达两亿次的疲劳试验和疲劳试验前后的流体动力性能试验证明,该材料在没有结构失效或功能退化的情况下,至少可以承受五年的使用寿命。根据实验后的 SEM 图像,可以预测这种材料可以实现更长的疲劳寿命。

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引用本文的文献

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In Silico Trials of Prosthetic Valves Replicate Methodologies for Evaluating the Fatigue Life of Artificial Leaflets to Expand Beyond In Vitro Tests and Conventional Clinical Trials.人工心脏瓣膜的计算机模拟试验复制了评估人工瓣叶疲劳寿命的方法,以超越体外测试和传统临床试验。
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Physiol Rev. 2024 Oct 1;104(4):1487-1532. doi: 10.1152/physrev.00038.2022. Epub 2023 Sep 21.
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An Algorithm for Automatic Generation and Evaluation of Leaflet Apparatus Models for Heart Valve Prostheses.
用于心脏瓣膜假体叶片仪器模型自动生成和评估的算法。
Sovrem Tekhnologii Med. 2022;14(4):6-14. doi: 10.17691/stm2022.14.4.01. Epub 2022 Jul 29.
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Polymeric Heart Valves Will Displace Mechanical and Tissue Heart Valves: A New Era for the Medical Devices.高分子心脏瓣膜将取代机械和组织心脏瓣膜:医疗器械的新时代。
Int J Mol Sci. 2023 Feb 16;24(4):3963. doi: 10.3390/ijms24043963.