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

用于构建人工肺以治疗危重呼吸衰竭的流体通道阵列砖 (FAB) 血气交换器

• 批准号: 10668676
• 负责人: Karlheinz Strobl
• 金额: $ 25.96万
• 依托单位: CVD EQUIPMENT CORPORATION
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-06-01 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10668676
• 关键词: Adult; Affect; Area; Blood; Blood coagulation; Blood flow; Blood gas; Carbon Dioxide; Coagulation Process; Complication; Custom; Development; Device Designs; Devices; Diffuse; Drops; Engineering; Equipment; Evaluation; Family; Fiber; Frequencies; Funding; Future; Gases; Goals; Government; Health; Health Care Costs; Health Personnel; Heart; Hemorrhage; Hemostatic Agents; Hour; Hypertension; In Vitro; Laboratories; Lead; Legal patent; Licensing; Life; Liquid substance; Lung; Lung Transplantation; Manufacturer Name; Medical Device; Microfluidics; Modeling; Morbidity - disease rate; Multiple Organ Failure; Operative Surgical Procedures; Outcome; Oxygenators; Patients; Pattern; Performance; Persons; Phase; Porosity; Procedures; Protocols documentation; Readiness; Recovery; Research; Respiratory Failure; Risk; Risk Factors; Safety; Self-Help Devices; Series; Small Business Innovation Research Grant; Stress; Surface; Technology; Testing; Transfusion; Treatment Failure; Venous; Work; artificial lung; base; blood damage; blood product; commercial application; commercialization; cost; design; improved; in vivo evaluation; infection risk; innovation; miniaturized device; mortality; novel; phase 1 study; predictive tools; pressure; prototype; scale up; shear stress; time use

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.

项目摘要/摘要 全世界超过100万患者的生命维护生命的O2和CO2气体交换具有关键 呼吸道衰竭或接受心脏/肺手术是通过流血到体外流动的 包含氧合剂的电路。市售的氧化剂使用专有的间隔组件 空心纤维（HFS）作为血液交换器。血液在这些HF的外部湍流，而 清扫气体流过他们的空心通道。通过微孔HF壁，O2扩散到血液中， 二氧化碳分散，将静脉血转化为动脉血。关键的止血并发症风险因素 氧化剂，例如血液接触区域，启动体积，湍流和高压流条件， 累积的剪切应力和气体转移率衰减构成影响成本的持续健康风险， 治疗，恢复，并因长期使用而进一步加剧，对发病率和 死亡。 HF氧合技术在过去十年中仅逐步改善，替代方案 可以显着提高性能和/或安全性的技术仍处于低流量阶段。 该SBIR提案的目的是开发优化的新型流体通道阵列（Fab）Blood-Gas 交换机，以最大程度地提高安全性，并利用时间为优化的更安全的Fab-goxygenators提供。 Fabs具有带有层流血流路径的直流流体通道的图案阵列，气体的孔隙率更高 与等效的HF组件相比，交换和较高的表面面积与体积比。优化 较高的效率Fab将导致体外氧合的安全性增长。这会减少血液 损害和凝血风险，解锁更长的使用潜力，减少血液产物输血以及 长期使用期间的替换频率，这进一步降低了医疗保健成本和感染风险。这 SBIR提案的长期目标是使一个更安全的Fab-goxygyator家族的发展，并具有 每个设备都根据特定患者类的需求量身定制。成年患者类别的fab-oxygenator缩放， 在未来的开发下，与完全优化的晶圆厂一起可能导致体外人造肺。 在第一阶段，我们将设计/制造一系列具有不同流体通道阵列图案的工厂并进行测试 它们内部最多6小时。这些结果将用于发展性能 预测优化，完整的成人fab-goxygenator，并结合了各自优化的晶圆厂。可行性 将通过FDA征用的AAMI 7199测试协议，通过体外评估建立 晶圆厂，建模和成人Fab-Goxygenator设计性能预测与商业HF的比较 氧化剂。第二阶段的资金将允许进一​​步发展和测试进一步改进和/或抗血栓形成涂层 最多使用7天的晶圆厂，并首先进行体内测试以优化安全增益优势。我们计划 与氧合制造商建立许可和辅助合作伙伴关系，并组装一个团队 可以共同将Fab-Axygantor推向市场的专家，临床医生，营销人员，制造商和工程师。