Development of Blood Delivery Networks for Silicon Nanomembrane-Enabled Low-Volume Membrane Oxygenators

硅纳米膜小容量膜氧合器血液输送网络的开发

• 批准号: 10323040
• 负责人: Steven Day
• 金额: $ 14.45万
• 依托单位: ROCHESTER INSTITUTE OF TECHNOLOGY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-01-01 至 2023-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10323040
• 关键词: Adverse event; Animal Model; Animals; Area; Biomedical Engineering; Blood; Blood Platelets; Blood Tests; Blood Volume; Blood gas; Buffers; Cardiac; Cattle; Childhood; Clinical; Coagulation Process; Complement Activation; Computer Models; Critical Care; Data; Development; Devices; Extracorporeal Membrane Oxygenation; Gases; Geometry; Goals; Height; Hemoglobin; Hemolysis; Hemorrhage; Hour; Human; In Vitro; Inflammatory Response; Institutes; Lead; Length; Life; Liquid substance; Lung; Medical Device; Membrane; Membrane Oxygenators; Methods; Modeling; Nanoporous; Neonatal; Newborn Infant; Oxygen; Oxygenators; Patients; Performance; Perfusion; Permeability; Plasma; Polymers; Polypropylenes; Process; Production; Pulmonary Pathology; Risk; Running; Safety; Silicon; Surface; System; Technology; Testing; Thrombelastography; Thrombin; Thrombus; Update; base; blood oxygenator; comparative; design; feeding; fluid flow; hemocompatibility; hemodynamics; improved; in silico; innovation; iterative design; manufacturability; miniaturize; model design; nanomembrane; patient population; pressure; prototype; pulmonary function; shear stress; silicon nitride; standard of care; success; thrombogenesis

Abstract The overall goal of this project is to optimize performance and hemocompatibility of prototype blood oxygenators enabled by silicon nanomembranes. To achieve this, the project brings together expertise in blood-contacting medical device hemodynamics (Co-PI Steven Day; Chair and Prof. Biomedical Engi- neering, Rochester Institute of Technology) with silicon nanomembrane production at SiMPore Inc. (Co-PI James Roussie). Together, SiMPore and RIT offer a high impact and innovative approach for pro- ducing device geometries and material systems. SiMPore’s nanomembranes offer orders-of-magnitude higher permeability than polymer membranes used in current ECMO oxygenators and compelling pre- liminary data are demonstrative of these advantages. Since the overall volume of an oxygenator is de- pendent on the surface area and permeability of its membranes, incorporating SiMPore’s highly perme- able silicon nanomembranes into an efficient blood delivery and gas exchange system will lead to scaled down circuit blood volumes and dramatically lower surface areas of blood exposure. Leveraging Co-PI Day’s expertise in modeling and testing of hemolytic and thrombogenic potential of blood-con- tacting medical devices, a blood delivery network will be iteratively designed in silico and tested with installed nanomembranes in vitro so that the full permeability of nanomembrane-based oxygenation is realized within a safe and efficient device geometry. Aim 1 will focus on iterative in silico prototype oxy- genator design and initial empirical performance characterization, while Aim 2 will focus on a perfected design’s hemocompatibility and comparative performance versus currently in-use polypropylene mem- brane oxygenators. Success out of this R21 project will lay the basis for testing of the nanomembrane- based oxygenator in animal models.

摘要 本项目的总体目标是优化原型血液的性能和血液相容性 由硅纳米膜实现的氧合器。为了实现这一目标，该项目汇集了专业知识， 血液接触医疗器械血流动力学（联合PI Steven Day;生物医学工程主席兼教授- neering，罗切斯特理工学院）与SiMPore公司的硅纳米膜生产。 （Co-PI詹姆斯·奥西）。SiMPore和RIT共同提供了一种高影响力和创新的方法， 引入器件几何形状和材料系统。SiMPore的纳米膜提供了数量级的 比当前ECMO氧合器中使用的聚合物膜具有更高的渗透性， 初步数据证明了这些优点。由于氧合器的总体积是去- 取决于其膜的表面积和渗透性，结合SiMPore的高渗透性， 将硅纳米膜引入有效的血液输送和气体交换系统将导致 按比例缩小回路血量，并显著降低血液暴露的表面积。利用 Co-PI Day在血液相容性的溶血和血栓形成潜力建模和测试方面的专业知识， 接触医疗设备，血液输送网络将在计算机中迭代设计，并进行测试， 在体外安装纳米膜，使得基于纳米膜的氧合的完全渗透性被 在安全和有效的装置几何形状内实现。目标1将侧重于迭代的硅原型氧- 发电机的设计和初步的经验性能表征，而目标2将集中在一个完善的 设计的血液相容性和与目前使用的聚丙烯缝线的比较性能， 膜式氧合器。这个R21项目的成功将为纳米膜的测试奠定基础- 基于氧合器的动物模型。