Integrated Maglev Pump-Oxygenator for Respiratory Support

描述(申请人提供)：慢性肺病仍然是美国第三大死因。仅成人呼吸窘迫综合征(ARDS)每年就困扰着大约15万名患者，死亡率在30%-70%之间。目前治疗呼吸衰竭的方法包括机械通气和体外膜氧合(ECMO)。机械通气对短期支持是有效的，但经常使用的持续潮气量和呼吸道压力也可能通过气压创伤、气囊创伤和其他医源性损伤损害肺。虽然ECMO系统模拟生理性气体交换，但这些系统受到其操作的复杂性、出血和患者流动性降低的限制。这些因素导致需要比预期更高的底涂量和膜表面积。为了克服这些限制，我们建议开发一种集成式磁悬浮泵-氧合器(IMPO)，它结合了耐用的膜和磁悬浮血泵技术，以产生低预充量的高效呼吸支持系统。IMPO旨在成为一个独立的血泵和血氧合器组件，使需要ECMO或创伤支持3至14天或更长时间的患者能够快速部署。在项目的第一阶段，我们对一个原型IMPO装置进行了建模、制造和测试，并在体外和体内评估了其气体传输效率和生物相容性。在目前的第二阶段研究中，我们打算完成IMPO设备的设计和验证，评估体内性能和生物兼容性，并在预期的临床试验中启动设备就绪测试。因此，我们的具体目标包括：具体目标1：设计优化的泵-叶轮和纤维配置的叶轮系统，以最大限度地提高氧气传输和生物相容性。具体目标2.完成IMPO的制作，并进行氧转移和生物相容性的体外评估。具体目的3.通过动物模型验证IMPO的血流动力学性能和生物相容性。该项目的成功完成将导致便携式泵式氧合器系统的开发，其特点是改善血液相容性和氧气效率。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)，因此应该对降低因严重、急性呼吸紊乱而导致的死亡率产生重大影响。叙述性 肺病是美利坚合众国的第三大死因，约占每7个成人死亡中的1个。据估计，目前有3000万美国人患有慢性肺部疾病。目前治疗呼吸衰竭的技术很复杂，与多种并发症相关，而且非常昂贵。拟议的集成膜泵氧合器(IMPO)是一种简单、便携和负担得起的技术，旨在为这些患有严重、急性、潜在可逆性呼吸衰竭的患者提供更好的治疗选择。

DESCRIPTION (provided by applicant): Chronic lung disease remains America's third largest cause of death. Adult respiratory distress syndrome (ARDS) alone afflicts approximately 150,000 patients every year with a mortality rate between 30-70%. Current therapy for respiratory failure includes mechanical ventilation and extracorporeal membrane oxygenation (ECMO). Mechanical ventilation is effective for short term support, yet the sustained tidal volumes and airway pressures often used may also damage the lungs via barotrauma, volutrauma, and other iatrogenic injuries. While ECMO systems simulate physiological gas exchange, these systems are limited by the complexity of its operation, bleeding, and reduced patient mobility. These factors lead to the need for higher than desired priming volumes and membrane surface areas. In order to overcome these limitations, we propose to develop an integrated maglev pump-oxygenator (IMPO), which incorporates durable membranes and magnetically levitated blood pump technology to produce a highly efficient respiratory support system with low priming volumes. The IMPO is intended to be a self-contained blood pump and blood oxygenator assembly enabling rapid deployment for a patient requiring ECMO or trauma support for 3 to 14 days or longer. In Phase I of the project, we modeled, fabricated and tested a prototype IMPO device and assessed its gas transfer efficiency and biocompatibility in vitro and in vivo. In the current Phase II research, we intend to complete the design and validation of the IMPO device, to assess in vivo performance and biocompatibility, and to launch device readiness testing in anticipation of clinical trials. Accordingly, our specific aims include: Specific Aim 1: Design the IMPO system with optimized pump- impeller and fiber configuration to maximize oxygen transfer and biocompatibility. Specific Aim 2. Complete IMPO fabrication and perform in vitro assessment of oxygen transfer and biocompatibility. Specific Aim 3. Demonstrate hemodynamic performance and biocompatibility of the IMPO in an animal model. Successful completion of this project will result in the development of a portable pump oxygenator system characterized by improved hemocompatibility and oxygen efficiency. We anticipate that such as system will be capable of providing long term respiratory support (weeks to months) and thus should have significant impact on the reduction of mortality due to severe, acute respiratory disorders.7. Narrative Lung disease is the third largest cause of death in the United States of America, accounting for approximately 1 out of every 7 adult deaths. It is estimated that 30 million Americans are living with chronic lung disease. The current technology for respiratory failure is complex, is associated with multiple complications and is very costly. The proposed Integrated Membrane Pump Oxygenator (IMPO) is a simple, portable and affordable technology designed to provide a better option for the treatment of these patients with severe, acute potentially reversible respiratory failure.