Fluid channel Array Brick (FAB) Blood-Gas Exchangers for building Artificial Lungs for Critical Respiratory Failure Treatment

项目摘要/摘要 为全球100多万名危重患者提供维持生命的基本氧气和二氧化碳气体交换 呼吸衰竭或接受心肺手术是通过体外循环血液提供的。 含有氧合器的电路。商业上可用的氧合器使用专有的间隔组件 中空纤维(HFs)用作血气交换器。血液在这些HFs的外部湍急流动，同时 扫过的气体流过它们的中空通道。通过微孔的HF壁，O2扩散到血液中， 二氧化碳扩散出去，将静脉血转化为动脉血。关键止血并发症危险因素分析 氧合器，如血液接触面积、引爆量、湍流和高压流动条件， 累积切应力和气体传输率衰减构成持续的健康风险，影响成本， 治疗和康复，以及长期使用会进一步加重，极大地促进了发病率和 死亡率。在过去的十年里，高频氧合器技术只是在逐步改进和替代 可以显著提高性能和/或安全性的技术仍处于低流量阶段。 该SBIR方案的目标是开发优化的新型流体通道阵列砖(FAB)血气 最大限度地增加安全收益，并为优化的更安全的FAB氧合器系列节省时间。 FAB具有直流道的图案阵列，具有层流的血液流动路径，气体具有更高的孔隙率 与同等的HF组件相比，它具有更高的表面积体积比。已优化 更高效率的FAB将导致显著的体外氧合器安全收益。这会降低血液 损害和凝血风险，释放更长的使用潜力，减少输血产品，以及 长期使用期间的更换频率，进一步降低了医疗成本和感染风险。这个 SBIR提案的长期目标是使开发更安全的FAB氧合器家族成为可能， 每个设备都是根据特定患者类别的需求量身定做的。FAB-氧合器扩大到成人患者类别， 再加上经过充分优化的FAB，在未来的开发中，可能会导致体外人工肺的出现。 在第一阶段，我们将设计/制造一系列具有不同流道阵列图案的FAB并进行测试 他们在FAB氧合器中停留长达6小时。这些结果将被用来制定一项表演 预测一个优化的，完整的成人FAB氧合器结合各自优化的FAB。可行性 将通过体外评估建立在FDA推荐的AAMI7199测试方案下的最优化 FABS、建模和成人FAB氧合器设计性能预测与商用HF的比较 氧合器。第二阶段的资金将允许开发和测试进一步改进和/或抗血栓涂层 使用FABS长达7天，并进行第一次体内测试，以完善安全获得优势。我们计划 与氧气机制造商建立许可和制造供应伙伴关系，并组建一支 专家、临床医生、营销人员、制造商和工程师，他们可以共同将FAB氧合器推向市场。

Project Summary/Abstract Essential life-maintaining O2 and CO2 gas exchange for over 1 million patients worldwide with critical respiratory failure or undergoing heart/lung surgery is provided by flowing blood through an extracorporeal circuit containing an oxygenator. Commercially available oxygenators use proprietary spaced assemblies of Hollow Fibers (HFs) as blood-gas exchangers. Blood flows turbulently around the outside of these HFs while a sweep gas flows through their hollow channels. Through the microporous HF walls, O2 diffuses into the blood, and CO2 diffuses out, converting venous blood into arterial blood. Key hemostatic complication risk factors of oxygenators, like blood-contact area, priming volume, turbulent and high-pressure flow conditions, accumulated shear stress, and gas transfer rate decay pose continuous health risks that affect costs, treatment, and recovery, and further aggravated by prolonged use, contribute significantly to morbidity and mortality. HF oxygenator technology has only incrementally improved over the last decade and alternative technologies that could significantly improve performance and/or safety are still in their low flow capacity stage. The goal of this SBIR proposal is to develop optimized novel Fluid channel Array Brick (FAB) blood-gas exchangers, for maximizing safety gains and use time for an optimized family of safer FAB-Oxygenators. FABs have a patterned array of straight fluid channels with laminar blood flow paths, higher porosity for gas exchange, and a higher surface-area-to-volume ratio compared to an equivalent HF assembly. Optimized higher efficiency FABs will lead to significant extracorporeal oxygenator safety gains. This will decrease blood damage and coagulation risk, unlock longer usage potential, reduce blood product transfusions, and replacement frequency during long-term use, which further reduces healthcare costs and infection risks. The long-term goal of the SBIR proposal is to enable the development of a family of safer FAB-Oxygenators, with each device tailored to the needs of a specific patient class. FAB-Oxygenator scale-up to adult patient class, together with fully optimized FABs, under a future development, could lead to an extracorporeal artificial lung. In Phase I, we will design/manufacture a series of FABs with different fluid channel array patterns and test them inside FAB-Oxygenators for up to 6 hours. These results will be used to develop a performance prediction for an optimized, full adult FAB-Oxygenators incorporating respective optimized FABs. Feasibility will be established by in vitro evaluation under the FDA-recommended AAMI 7199 test protocol of optimized FABs, modeling, and adult FAB-Oxygenator design performance prediction comparison to commercially HF oxygenators. Phase II funding will allow to develop and test further improved and/or antithrombotic coated FABs for up to 7 days of use, and to conduct first in vivo testing to refine safety gain advantages. We plan to establish licensing and FAB-supply partnerships with oxygenator manufacturers and to assemble a team of experts, clinicians, marketers, manufacturers, and engineers who can jointly bring FAB-Oxygenators to market.