Gawlikowski Maciej, El Fray Miroslawa, Janiczak Karolina, Zawidlak-Węgrzyńska Barbara, Kustosz Roman
Faculty of Biomedical Engineering, Department of Biosensors and Processing of Biomedical Signals, Silesian University of Technology, Roosevelta 40, 41-800 Zabrze, Poland.
Foundation of Cardiac Surgery Development, Artificial Heart Laboratory, Wolności 345a, 41-800 Zabrze, Poland.
Polymers (Basel). 2020 Nov 29;12(12):2857. doi: 10.3390/polym12122857.
(1) Background: The evaluation of ventricular assist devices requires the usage of biocompatible and chemically stable materials. The commonly used polyurethanes are characterized by versatile properties making them well suited for heart prostheses applications, but simultaneously they show low stability in biological environments. (2) Methods: An innovative material-copolymer of poly(ethylene-terephthalate) and dimer linoleic acid-with controlled and reproducible physico-mechanical and biological properties was developed for medical applications. Biocompatibility (cytotoxicity, surface thrombogenicity, hemolysis, and biodegradation) were evaluated. All results were compared to medical grade polyurethane currently used in the extracorporeal heart prostheses. (3) Results: No cytotoxicity was observed and no significant decrease of cells density as well as no cells growth reduction was noticed. Thrombogenicity analysis showed that the investigated copolymers have the thrombogenicity potential similar to medical grade polyurethane. No hemolysis was observed (the hemolytic index was under 2% according to ASTM 756-00 standard). These new materials revealed excellent chemical stability in simulated body fluid during 180 days aging. (4) Conclusions: The biodegradation analysis showed no changes in chemical structure, molecular weight distribution, good thermal stability, and no changes in surface morphology. Investigated copolymers revealed excellent biocompatibility and great potential as materials for blood contacting devices.
(1) 背景：心室辅助装置的评估需要使用生物相容性好且化学稳定的材料。常用的聚氨酯具有多种特性，使其非常适合心脏假体应用，但同时它们在生物环境中的稳定性较低。(2) 方法：开发了一种创新材料——聚（对苯二甲酸乙二酯）和二聚亚油酸的共聚物，其具有可控且可重复的物理机械和生物学特性，用于医学应用。评估了生物相容性（细胞毒性、表面血栓形成性、溶血和生物降解）。所有结果均与目前体外心脏假体中使用的医用级聚氨酯进行比较。(3) 结果：未观察到细胞毒性，未发现细胞密度显著降低以及细胞生长减少。血栓形成性分析表明，所研究的共聚物具有与医用级聚氨酯相似的血栓形成潜力。未观察到溶血现象（根据ASTM 756 - 00标准，溶血指数低于2%）。这些新材料在180天老化过程中在模拟体液中显示出优异的化学稳定性。(4) 结论：生物降解分析表明化学结构、分子量分布无变化，热稳定性良好，表面形态无变化。所研究的共聚物显示出优异的生物相容性，作为血液接触装置的材料具有巨大潜力。
