Yang M, Zhang Z, Hahn C, Laroche G, King M W, Guidoin R
Department of Surgery, Laval University and Quebec Biomaterials Institute Inc., Canada.
J Biomed Mater Res. 1999 Spring;48(1):13-23. doi: 10.1002/(sici)1097-4636(1999)48:1<13::aid-jbm4>3.0.co;2-4.
In the development of a new generation of totally implantable artificial hearts and left ventricular assist devices (VADs) for long-term use, the selection of an acceptable material for the fabrication of the ventricles probably represents one of the greatest challenges. Segmented polyether urethanes used to be the material of choice due to their superior flexural performance, acceptable blood compatibility, and ease of processing. However, because they are known to degrade and to be readily permeable to water, they cannot meet the rigorous requirements needed for a new generation of implantable artificial hearts and VADs. Therefore, the objective of the present study was to identify alternative polymeric materials that would be satisfactory for fabricating the ventricles, and in particular, to determine the water permeability through membranes made from four commercial polycarbonate urethanes (Carbothane PC3570A, Chronoflex AR, Corethane 80A, and Corethane 55D) in comparison to those made from two traditional polyether urethanes (Tecoflex EG80A and Tecothane TT-1074A). In addition to determining the rate of water transmission through the six membranes by exposing them to deionized water, saline, and albumin-Krebs solution under pressure and measuring the displacement of liquid by means of a recently developed capillary method, the inherent surface and chemical properties of the six membranes were characterized by SEM, contact angle measurements, FTIR, DSC, and GPC techniques. The results of the study demonstrated that the rate of water transmission through the four polycarbonate urethane membranes was significantly lower than through the two polyether urethanes. In fact the lowest values were recorded with the two Corethane membranes, and the harder type 55D polymer had a lower value (2.7 x 10(-7) g/s cm2) than the softer 80A version (3.3 x 10(-7) g/s cm2). This level of water vapor permeability, which appears to be controlled primarily by a Fickian diffusion mechanism, is between 2 and 4 times lower than that obtained with traditional polyether urethane membranes of equivalent thickness. The superior performance of the polycarbonate urethanes is likely due to the inherently lower chain mobility of the carbonate structure in the soft segment phase. In addition, the study shows that additional impermeability to water vapor can be achieved by selecting a polyurethane polymer with a high hard segment content, an aromatic rather than aliphatic diisocyanate comonomer, and a more hydrophobic surface. The use of a higher molecular weight polyurethane is not necessarily efficacious if the above requirements are not met. As expected by Raoult's Law, the study found that the use of physiological media instead of deionized water further decreases the rate of water vapor transmission. Because none of today's commercial polyurethanes are totally impervious to water vapor transmission, additional work is needed to develop permeable polymers or to apply additional treatments to existing candidates to achieve an acceptable impermeable ventricle material.
在开发新一代可长期使用的完全植入式人工心脏和左心室辅助装置(VAD)的过程中,选择一种可接受的用于制造心室的材料可能是最大的挑战之一。由于其优异的弯曲性能、可接受的血液相容性和易于加工,分段聚醚聚氨酯曾经是首选材料。然而,由于已知它们会降解且易于透水,它们无法满足新一代植入式人工心脏和VAD所需的严格要求。因此,本研究的目的是确定适合制造心室的替代聚合物材料,特别是与由两种传统聚醚聚氨酯(Tecoflex EG80A和Tecothane TT - 1074A)制成的膜相比,测定由四种商用聚碳酸酯聚氨酯(Carbothane PC3570A、Chronoflex AR、Corethane 80A和Corethane 55D)制成的膜的透水性。除了通过在压力下将六种膜暴露于去离子水、盐水和白蛋白 - 克雷布斯溶液并通过最近开发的毛细管方法测量液体位移来确定水透过六种膜的速率外,还通过扫描电子显微镜(SEM)、接触角测量、傅里叶变换红外光谱(FTIR)、差示扫描量热法(DSC)和凝胶渗透色谱法(GPC)技术对六种膜的固有表面和化学性质进行了表征。研究结果表明,通过四种聚碳酸酯聚氨酯膜的水传输速率明显低于通过两种聚醚聚氨酯膜的速率。事实上,两种Corethane膜的数值最低,较硬的55D型聚合物的值(2.7×10⁻⁷ g/s·cm²)低于较软的80A版本(3.3×10⁻⁷ g/s·cm²)。这种水蒸气渗透率水平似乎主要由菲克扩散机制控制,比同等厚度的传统聚醚聚氨酯膜低2至4倍。聚碳酸酯聚氨酯的优异性能可能归因于软段相中碳酸酯结构固有的较低链流动性。此外,研究表明,通过选择具有高硬段含量、芳香族而非脂肪族二异氰酸酯共聚单体以及更疏水表面的聚氨酯聚合物,可以实现额外的水蒸气不渗透性。如果不满足上述要求,使用更高分子量的聚氨酯不一定有效。正如拉乌尔定律所预期的,研究发现使用生理介质而非去离子水会进一步降低水蒸气传输速率。由于当今没有一种商用聚氨酯能完全不透水蒸气传输,因此需要开展更多工作来开发可渗透聚合物或对现有候选材料进行额外处理,以获得可接受的不透水心室材料。