Artificial Placenta Device

人工胎盘装置

• 批准号: 8787193
• 负责人: George Boris Mychaliska
• 金额: $ 63.68万
• 依托单位: MC3, INC.
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-13 至 2016-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8787193
• 关键词: Accounting; Animal Model; Anticoagulation; Birth; Blood; Blood Circulation; Blood flow; Blood gas; Breathing; Cannulas; Caring; Cerebrum; Characteristics; Clinical; Clinical Trials; Date of birth; Development; Devices; Drainage procedure; Engineering; Environment; Environmental air flow; Exposure to; Failure; Force of Gravity; Future; Gases; Gestational Age; Goals; Health; Heating; Hemolysis; Hour; In Vitro; Infant; Internal jugular vein structure; Lead; Life; Liquid substance; Lung; Maintenance; Measures; Mechanical ventilation; Mechanics; Medical; Michigan; Modeling; Morbidity - disease rate; Neuraxis; Newborn Infant; Nitric Oxide; Organ; Oxygenators; Performance; Perfusion; Phase; Placenta; Polymers; Pregnancy; Premature Birth; Premature Infant; Pump; Reproducibility; Research; Research Project Grants; Resuscitation; Running; Safety; Surface; System; Technology; Temperature; Testing; Therapeutic; Trauma; Umbilical vein; United States; Universities; Venous; clinical practice; cost; design; exhaust; extreme prematurity; fetal; gastrointestinal; hemodynamics; high risk; in vitro testing; in vivo; indexing; infant death; innovation; meetings; miniaturize; mortality; novel; oxygen toxicity; premature; pressure; prototype; respiratory; success; surfactant; treatment strategy

DESCRIPTION (provided by applicant): There are 5 million births in the United States each year of which 500,000 are premature. Prematurity is associated with substantial mortality, morbidity, and escalating cost. The complications of premature birth include respiratory, gastrointestinal, and central nervous system morbidity, and significant mortality. Many of these complications are caused, directly or indirectly, by our attempts to ventilate the immature lungs and reverse fetal circulation. Although many of these babies recover with conventional management, the mortality and morbidity of extremely low gestational age newborns (ELGANs) defined as born more than 3 months before the expected date of birth, is very high. The current approach of positive pressure gas ventilation carries high risks of mechanical trauma and oxygen toxicity to the lungs. A major paradigm shift in the post-natal treatment of prematurity would be to avoid the complications of positive pressure ventilation and recreate the fetal environment with an Artificial Placenta (AP) which consists of four unique features: 1) maintaining fetal circulation and environment; 2) no mechanical ventilation; 3) simulated fetal breathing with fluid filled lungs; and 4) a novel form of a pump-driven veno-venous extracorporeal life support (VV-ECLS) circuit with inflow via the umbilical vein and outflow via the right internal jugular vein. Our collaborators at the University of Michigan Extracorporeal Life Support Lab (ECLS Lab) have demonstrated feasibility and reproducibility of complete extracorporeal support with medical components to simulate an artificial placenta for up to 7 days with hemodynamic stability, excellent gas exchange, stable cerebral perfusion, and maintenance of fetal circulation without mechanical ventilation. The goal of this research project is to design and produce an integrated system that will function as an Artificial Placenta for the post-natal treatment of very premature infants (<28 weeks gestational age). Our system will support ELGANs in the most natural state (i.e., fetal circulation), and is truly innovative and offers many therapeutic opportunities when compared to current clinical practice with mechanical ventilation. Phase l aims include integration of the MC3 BioLung and MPump devices with cartridge heat modules and an automated sweep gas controller. The system will be coated with our unique nonthrombogenic NO secreting polymer to decrease or eliminate the need for systemic anticoagulation. The prototype system will be fabricated and tested in vitro to demonstrate safety, efficacy and durability. A pilot in vivo study will be conducted to demonstrate effective fetal circulation. Phase ll will include extended in vivo testing of AP for safety and efficacy, and the development of a clinical ready device. The University of Michigan Extracorporeal Life Support Lab and MC3 are the leaders in this field and can bring this technology to reality in four years. This project has high translational potential and would impact substantially upon the care of high risk premature newborns. Successful completion of this research will lead to a clinical trial in moribund premature infants.

描述（由申请人提供）：美国每年有500万个出生，其中500,000个为时过早。早产与重大死亡率，发病率和升级成本有关。早产的并发症包括呼吸道，胃肠道和中枢神经系统发病率以及显着的死亡率。这些并发症中的许多并发症是直接或间接引起的，我们试图通风未成熟的肺和反向胎儿循环。尽管这些婴儿中有许多通过常规管理恢复，但定义为在预期出生日期之前超过3个月出生的极低胎龄新生儿（Elgans）的死亡率和发病率非常高。当前的正压气通气方法具有机械外伤的高风险和对肺部的氧气毒性。产后治疗早产的主要范式转移是避免正压通气的并发症，并使用人造胎盘（AP）重现胎儿环境，该胎盘（AP）由四个独特的特征：1）维持胎儿循环和环境； 2）没有机械通气； 3）模拟胎儿呼吸，充满液体肺； 4）一种新型形式的泵驱动的静脉静脉外生命支持（VV-ECLS）电路，通过脐静脉流动，并通过右内颈内静脉流出。 我们在密歇根大学体外生命支持实验室（ECLS LAB）的合作者表现出可行性和可重现性，可与医疗组件进行完整的体外支持，以模拟人造胎盘座，以进行长达7天的血液动力学稳定性，出色的气体交换，稳定的脑灌注，以及fe虫循环，而无需机械通风。该研究项目的目的是设计和生产一个集成系统，该系统将充当人工胎盘胎，以便在产后治疗非常过早的婴儿（胎龄<28周）。我们的系统将支持最自然状态（即胎儿循环）的Elgans，并且与当前的机械通气相比，与当前的临床实践相比，确实具有创新性，并提供许多治疗机会。 L期目标包括将MC3 Biolung和Mpump设备与墨盒热模块和自动扫描气体控制器集成。该系统将与我们独特的非组织性无分泌聚合物一起覆盖，以减少或消除全身抗凝的需求。原型系统将在体外进行制造和测试，以证明安全性，功效和耐用性。将进行一项试点研究，以证明有效的胎儿循环。 LL期将包括对AP的扩展体内测试，以确保安全性和功效，以及临床准备就绪设备的开发。密歇根大学体外生命支持实验室和MC3是该领域的领导者，可以在四年内将这项技术实现。该项目具有很高的翻译潜力，会影响 在照顾高风险的早产新生儿的基本上。这项研究的成功完成将导致垂死的早产儿进行临床试验。