Novel Dense Hollow Fiber for Blood-Gas Exchange

描述(由申请人提供)： 我们设计了一种技术，可以大大简化致密硅胶膜中空纤维(SMHF)的制造，并使其具有成本效益，用于血气交换应用，包括长期体外生命支持、植入性人工肺和其他心肺程序。SMHF可以用来制造无孔、高性能和经济上有吸引力的紧凑型氧合器，类似于微孔膜中空纤维(MMHF)设备。目前使用MMHF的设备很流行，因为血液在数千个微小的中空纤维上流动时会引起对流混合，从而增强了气体交换。这一特性允许以相对紧凑的体积设计高效的气体交换装置。然而，MMHF在长时间使用时会出现粘连和血浆泄漏，当气体侧压力超过血液侧压力时会出现气体栓塞。然而，目前还没有类似的非微孔中空纤维氧合器。目前的SMHF结合了MMHFs的紧凑性和有效性，以及抵御血浆泄漏和气体栓塞的能力。在第一阶段，我们证明了SMHF可以使用我们的专有工艺连续可靠地制造，并且使用我们的SMHF测试氧合模块的性能与MMHF相当。在第二阶段，我们建议进一步开发和扩大制造技术，以评估成人尺寸氧合器中SMHF的气体交换、血流动力学性能和抗血浆穿透能力。这些研究将在试验台上进行，也将在体内进行。

DESCRIPTION (provided by applicant): We have devised a technique that will greatly simplify and make cost effective the fabrication of dense silicone membrane hollow fibers (SMHF) for use in blood gas exchange applications including long-term extracorporeal life support, implantable artificial lung, and other cardiorespiratory procedures. The SMHF can be used to make non-porous, high performing, and economically attractive compact oxygenators, analogous to microporous membrane hollow fiber (MMHF) devices. Current devices using MMHF are prevalent because of enhanced gas exchange due to the convective mixing induced by blood flowing over thousands of tiny hollow fibers. This property allows for designing highly efficient gas exchange devices in relatively compact volumes. Yet MMHF suffer from fowling, and plasma leakage when they are used for extended periods of time, and from gas embolization when the gas side pressure exceeds the blood side pressure. Nonetheless there is currently no analogous non-microporous hollow fiber oxygenators. The present SMHF incorporates the compactness and effectiveness of MMHFs plus the ability to withstand plasma leakage and gas embolization. In Phase 1 we demonstrated that the SMHF can be fabricated continuously and reliably using our proprietary process, and that test oxygenating modules using our SMHF perform comparably to the MMHF counterparts. In Phase 2 we propose to further develop and scale-up the fabrication technique to evaluate the gas exchange, hemodynamic performance, and resistance to plasma breakthrough of the SMHF in adult size oxygenators. These studies will be performed on the bench as well as in-vivo.