A Compact, Cardiopulmonary Support Device

紧凑型心肺支持装置

• 批准号: 7537048
• 负责人: Keith E Cook
• 金额: $ 16.22万
• 依托单位: MC3, INC.
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-15 至 2010-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7537048
• 关键词: Acute respiratory failure; Address; Adult Respiratory Distress Syndrome; Affect; Area; Blood; Blood Platelets; Blood Tests; Blood flow; Blood gas; Cannulations; Carbon Dioxide; Cardiac; Cardiac Output; Cardiopulmonary; Chronic; Chronic lung disease; Complication; Condition; Development; Device Designs; Devices; Ensure; Erythrocytes; Excision; Exercise; Extravasation; Functional disorder; Gases; Glycerol; Grant; Heart; Heart Rate; Hemostatic Agents; Human; Immunologics; In Vitro; Inflammation; Infusion procedures; Intra-Aortic Balloon Pumping; Laboratories; Leukocytes; Life; Liquid substance; Lung; Lung Transplantation; Lung diseases; Marketing; Mechanical ventilation; Membrane; Michigan; Monitor; Operative Surgical Procedures; Organ Donor; Organ failure; Oxyhemoglobin; Patient Care; Patients; Phase; Public Health; Pulmonary Vascular Resistance; Pump; Quality of Care; Rate; Recovery; Resistance; Respiratory distress; Rest; Safety; Sales; Savings; Sheep; Surface; System; Technology; Technology Transfer; Testing; Transplantation; Universities; Venous; Ventilator; Waiting Lists; Week; Work; biomaterial compatibility; cost; day; design; improved; in vivo; innovation; mortality; novel; performance tests; pressure; prototype; respiratory; success; ventricular assist device

DESCRIPTION (provided by applicant): The objective of this Phase I grant is to develop and test a compact cardiopulmonary support device (CCSD). This device pumps, transfers gas, and warms blood. The CCSD is attached to the patient via venovenous (VV) or venoarterial (VA) cannulation and supplies respiratory support like extra-corporeal membrane oxygenation (ECMO) and pulsatile cardiac support similar to a ventricular assist device. Unlike ECMO circuits, all these functions are accomplished within one compact, low-resistance device. Therefore, the CCSD has a small amount of blood contact surface area and a low-shear blood flow. This leads to low damage and activation to red blood cells, platelets, and leukocytes, allowing for respiratory support for months without infused blood products and a lower complication rate than ECMO. The device is intended to provide respiratory and, if needed, cardiac support for patients with severe acute respiratory failure or chronic pulmonary disease. The only long-term treatment for chronic pulmonary disease is lung transplantation, but the waiting list has increased 300% over the last decade. In this situation, the CCSD would i) bridge patients on the waiting list until a suitable donor organ could be found, ii) support patients with respiratory distress after transplantation, and iii) might allow for transplantation with marginal donor organs. Acute respiratory failure affects more than 150,000 people per year in the US, with mortality rates of 34-65%. For these patients, the device would allow for less aggressive mechanical ventilation, reducing ventilator induced organ failure, aiding recovery, and reducing mortality. Significant preliminary design work has been performed at the University of Michigan to arrive at a CCSD design with high gas exchange, low blood flow resistance, and a high degree of biocompatibility. Phase I will be used to fabricate that design and ensure that it meets the following feasibility specifications: the CCSD has minimal areas of stasis, the CCSD can pump and fully oxygenate up to 5 L/min of blood both in vitro and in vivo, and the CCSD can operate in vitro for one week without leaking. To test these specifications, the following specific aims will be pursued: Specific Aim #1: Optimize device blood flow fields using computational fluid dynamics Specific Aim #2: Fabricate CCSD prototypes for performance testing Specific Aim #3: Perform in vitro testing using glycerol to examine pumping ability of the CCSD. Specific Aim #4: Perform in vitro blood tests to determine CCSD gas exchange function and stasis regions Specific Aim #5: Perform in vitro, seven-day durability testing of the CCSD Specific Aim #6: Perform short-term (< 8 hr) in vivo testing of the CCSD to prove safety and efficacy. Specific Aims 2 and 5 will be performed at MC3, Inc. Specific Aims 1, 3, 4 and 6 will be performed at the University of Michigan. PUBLIC HEALTH RELEVANCE This grant will result in the development of a novel compact cardiopulmonary support device (CCSD) that can supply both respiratory and cardiac support. The new CCSD will improve treatment options for patients with either severe acute respiratory failure or chronic pulmonary disease.

描述（由申请人提供）：本阶段资助的目的是开发和测试一种紧凑型心肺支持装置（CCSD）。这个装置可以泵送、输送气体、加热血液。CCSD通过静脉-静脉（VV）或静脉-动脉（VA）插管连接到患者身上，并提供呼吸支持，如皮质外膜氧合（ECMO）和类似于心室辅助器械的脉动心脏支持。与ECMO电路不同，所有这些功能都在一个紧凑的低电阻设备中完成。因此，CCSD具有少量的血液接触表面积和低剪切血流。这导致对红细胞，血小板和白细胞的低损伤和活化，允许呼吸支持数月而无需输注血液制品，并发症发生率低于ECMO。该器械预期用于为严重急性呼吸衰竭或慢性肺病患者提供呼吸支持，并在需要时提供心脏支持。慢性肺病的唯一长期治疗方法是肺移植，但在过去十年中，等待名单增加了300%。在这种情况下，CCSD将i）在等待名单上的患者之间建立桥梁，直到找到合适的供体器官，ii）支持移植后呼吸窘迫的患者，以及iii）可能允许边缘供体器官移植。在美国，急性呼吸衰竭每年影响超过15万人，死亡率为34- 65%。对于这些患者，该装置将允许较不积极的机械通气，减少呼吸机引起的器官衰竭，帮助恢复，并降低死亡率。在密歇根大学进行了重要的初步设计工作，以获得具有高气体交换、低血流阻力和高度生物相容性的CCSD设计。第一阶段将用于制造该设计，并确保其符合以下可行性规范：CCSD具有最小的停滞区域，CCSD可以在体外和体内泵送和完全吸收高达5 L/min的血液，CCSD可以在体外运行一周而不会泄漏。为了测试这些质量标准，将追求以下具体目标：具体目标#1：使用计算流体动力学优化器械血流场具体目标#2：制造CCSD原型用于性能测试具体目标#3：使用甘油进行体外测试，以检查CCSD的泵送能力。具体目标#4：进行体外血液测试以确定CCSD气体交换功能和停滞区域具体目标#5：进行CCSD的体外7天耐久性测试具体目标#6：进行CCSD的短期（< 8小时）体内测试以证明安全性和有效性。具体目标2和5将在MC 3，Inc.进行。具体目标1、3、4和6将在密歇根大学进行。公共卫生相关性该补助金将用于开发一种新型紧凑型心肺支持设备（CCSD），该设备可以提供呼吸和心脏支持。新的CCSD将改善严重急性呼吸衰竭或慢性肺部疾病患者的治疗选择。