Integrated Maglev Pump-Oxygenator for Respiratory Support

描述(申请人提供)：自1979年以来，美国呼吸系统疾病的死亡率增加了近20%，几乎超过了所有其他类型的疾病。仅成人呼吸窘迫综合征(ARDS)每年就有大约15万名患者，死亡率在30%到70%之间。目前的治疗方法仅限于体外膜氧合(ECMO)，但ECMO系统通常由多个不匹配的组件组装而成，以创建泵-氧合器电路。由于血流动力学的不优化，这些回路导致的预充量和膜表面积高于预期。为了克服这些局限性，我们提出了一种能够持续呼吸支持的新型人工呼吸装置的开发。这项提议的目标是开发一种集成泵-氧合器(IPO)设备，该设备结合了耐用的膜和磁悬浮血泵技术，以产生低引爆量的高效呼吸支持系统。因此，我们的具体目标包括：具体目标1：利用流体模拟方法对血液泵功能、气体传输和血液相容性进行建模，并利用这些结果设计和制造具有最佳尺寸和操作参数的氧合器组件。具体目标2：制作用于体外鉴定的IPO原型装置的组件，包括评估装置的血流性能。具体目的3：利用牛血在体外评价该装置的气体交换及对血液的影响。具体目的4：在绵羊身上进行活体动物研究(3)评估IPO装置的体内血流动力学、气体交换和生物相容性。该项目的成功完成将导致便携式泵式氧合器系统的开发，其特点是由于使用了磁悬浮泵而改善了血液相容性，由于增强了血液再循环和血液流动动力学而提高了氧气效率，并且由于其模块化设计而易于制造。我们预计，这样的系统将能够提供长期的呼吸支持(几周到几个月)。这种设备的可用性应该对降低由于严重的急性呼吸系统疾病而导致的死亡率产生重大影响。

DESCRIPTION (provided by applicant): The death rate due to respiratory disease has increased nearly 20% in the United States since 1979, surpassing virtually all other types of disease. Adult respiratory distress syndrome (ARDS) alone afflicts approximately 150,000 patients every year with a mortality rate between 30 and 70%. Current treatment is limited to extracorporeal membrane oxygenation (ECMO), but ECMO systems are generally assembled from multiple, unmatched components to create a pump-oxygenator circuit. These circuits result in higher than desired priming volume and membrane surface area because of non-optimized blood flow dynamics. In order to overcome these limitations, we have proposed the development of a novel artificial respiratory device capable of sustained respiratory support. The goal of this proposal is to develop an integrated pump-oxygenator (IPO) device, which incorporates durable membranes and magnetically levitated blood pump technology to produce a highly efficient respiratory support system with low priming volumes. Accordingly, our specific aims include the following: Specific Aim 1: Employ fluid simulation methods to model blood pumping function, gas transfer and hemocompatibility, and use these results to design and fabricate oxygenator components with optimal size and operating parameters. Specific Aim 2: Fabricate the components of the IPO prototype device for in-vitro characterization, including an evaluation of device blood flow performance. Specific Aim 3: Evaluate the device in-vitro utilizing bovine blood to assess gas exchange and the effects on blood. Specific Aim 4: Conduct in-vivo animal studies (3) in sheep to assess in-vivo hemodynamics, gas exchange and biocompatibility of the IPO device. Successful completion of this project will result in the development of a portable pump oxygenator system characterized by improved hemocompatibility, due to the use of the MagLev pump, improved oxygen efficiency, due to enhanced blood recirculation and blood flow dynamics, and ease of manufacturing, due to its modular design. We anticipate that such as system will be capable of providing long term respiratory support (weeks to months). The availably of such a device should have significant impact on reducing mortality due to severe, acute respiratory disorders.