Integrated Maglev Pump-Oxygenator for Respiratory Support

用于呼吸支持的集成磁悬浮泵氧合器

• 批准号: 7394602
• 负责人: KURT A DASSE
• 金额: $ 69.22万
• 依托单位: THORATEC, LLC
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-05 至 2010-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7394602
• 关键词: Accounting; Acute; Address; Adult; Adult Respiratory Distress Syndrome; American; Americas; Animal Experiments; Animal Model; Animals; Area; Artificial Organs; Baltimore; Binding; Blood; Blood Circulation; Blood flow; Bos taurus; Cannulas; Caring; Cattle; Cause of Death; Cessation of life; Childhood; Chronic lung disease; Clinical Trials; Complex; Condition; Development; Devices; Dysbarism; Extracorporeal Membrane Oxygenation; Failure; Fiber; Gases; Head; Hemorrhage; Implant; In Vitro; Injury; Joints; Laboratories; Lead; Life; Liquid substance; Lung; Lung diseases; Maryland; Measures; Mechanical ventilation; Membrane; Methods; Microscopic; Modeling; Motor; Newborn Respiratory Distress Syndrome; Numbers; Operative Surgical Procedures; Oxygen; Oxygenators; Patients; Performance; Phase; Physiological; Pump; Range; Rate; Readiness; Research; Resistance; Respiration Disorders; Respiratory Failure; Safety; Sampling; Series; Simulate; Support System; Surface; System; Technology; Temperature; Testing; Thrombus; Tidal Volume; Trauma; United States; Universities; Validation; Venous; Vent; Volutrauma; Week; biomaterial compatibility; blood oxygenator; blood pump; day; design; desire; hemodynamics; improved; in vivo; model design; mortality; pressure; prototype; research study; respiratory; simulation

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.

描述（由申请人提供）：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) 每年就会影响大约 150,000 名患者，死亡率在 30-70% 之间。目前呼吸衰竭的治疗包括机械通气和体外膜肺氧合（ECMO）。机械通气对于短期支持是有效的，但经常使用的持续潮气量和气道压力也可能通过气压伤、体积伤和其他医源性损伤损害肺部。虽然 ECMO 系统模拟生理气体交换，但这些系统受到操作复杂性、出血和患者活动能力降低的限制。这些因素导致需要高于预期的启动体积和膜表面积。为了克服这些限制，我们建议开发一种集成磁悬浮泵氧合器（IMPO），它结合了耐用的膜和磁悬浮血泵技术，以产生低启动量的高效呼吸支持系统。 IMPO 旨在成为一种独立的血泵和血液氧合器组件，能够为需要 ECMO 或创伤支持 3 至 14 天或更长时间的患者快速部署。在该项目的第一阶段，我们建模、制造和测试了原型 IMPO 装置，并评估了其气体传输效率和体外和体内生物相容性。在当前的二期研究中，我们打算完成IMPO设备的设计和验证，评估体内性能和生物相容性，并启动设备准备测试以应对临床试验。因此，我们的具体目标包括： 具体目标 1：设计具有优化泵叶轮和纤维配置的 IMPO 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 制造并对氧传递和生物相容性进行体外评估。具体目标 3. 在动物模型中展示 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（数周至数月），因此应该对降低严重、急性呼吸系统疾病所致的死亡率产生重大影响。7。叙述 肺部疾病是美国第三大死因，约占成人死亡人数的七分之一。据估计，有 3000 万美国人患有慢性肺病。目前治疗呼吸衰竭的技术很复杂，与多种并发症相关，而且成本非常高。拟议的集成膜泵氧合器（IMPO）是一种简单、便携式且价格实惠的技术，旨在为治疗这些患有严重、急性潜在可逆性呼吸衰竭的患者提供更好的选择。