CircuLite's Circulatory Support System in Children and Infants

CircuLite 儿童和婴儿循环支持系统

基本信息

批准号：
7672168
负责人：
Gail G Farnan
金额：
$ 46.56万
依托单位：
CIRCULITE, INC.
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-07-15 至 2010-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7672168
关键词：
Adolescent Adult Animal Experiments Animal Testing Animals Apical Artificial Organs Assisted Circulation Award Baltimore Belgium Berlin Biocompatible Blood Blood Circulation Blood flow Body Surface Area Body Weight Cardiac Cardiogenic Shock Cardiovascular Diseases Cardiovascular system Child Childhood Chronic Clinical Clinical Trials Computer Simulation Contracts Development Devices Electronics Emergency Situation Enrollment Equipment Europe European Evaluation Extracorporeal Membrane Oxygenation Figs - dietary Freezing Funding Future Germany Glycerol Goals Heart Heart Transplantation Heart failure Hospitals Housing Human Hybrids Image Implant In Vitro Infant Lead Left Legal patent Liquid substance Magnetism Maryland Mechanics Medical Miniaturization Modeling Motor National Heart, Lung, and Blood Institute Outcome Study Pacemakers Patients Performance Phase Phase I Clinical Trials Polytetrafluoroethylene Power Sources Procedures Process Protocols documentation Pump Quality of life Readiness Recovery Risk Safety Series Sheep Small Business Innovation Research Grant Support System System Techniques Technology Testing Thrombosis Time Translating Transplantation United States United States Food and Drug Administration Universities Validation Velocimetries Ventricular Water base biomaterial compatibility blood pump commercialization data acquisition design digital effective therapy ergonomics experience hemodynamics implantable device implantation improved in vivo innovation manufacturing process meetings model design multidisciplinary novel particle pilot trial pre-clinical programs prototype public health relevance research study success tool usability ventricular assist device

项目摘要

DESCRIPTION (provided by applicant): Sophisticated ventricular assist devices (VADs) are now routinely used for bridge to recovery, or bridge to transplant in heart failure patients. However, the success of the VADs' applications in adults has not been translated into that in pediatric application, due to the delays in the miniaturization process of these devices. To date, the need of VADs for infant and child with congenital or acquired cardiovascular disease has largely been unmet. Hundreds of infants and children die each year in the United States while waiting for a donor heart. The goal of this "Fast Track" SBIR application is to develop long-term implantable miniature VADs for infant and child, built upon the success of the current CircuLite Synergy device. The Synergy device is a unique proprietary and patented miniature VAD. Through a decade of development, it has been refined to be the smallest implantable blood pump, only of the size of an "AA" battery. The device is currently undergoing the CE Mark Trial in Europe and pending USFDA IDE submission. The goal of the Phase I project is to demonstrate the feasibility of using the current CircuLite micro-pump (1.5-3 L/min flow) for child (5-35 kg) by modifying the inlet housing of the device for left ventricular apical insertion, while the Phase II project is to demonstrate the feasibility of further modifying the micro-pump (redesigning the impeller or reducing the pump size) to achieve a reduced flow of 0.3-1.5 L/min for use in an infant (<5 kg). The milestone of the Phase I project will be the delivery of a child VAD that has undergone short-term animal studies. In Phase II, we will further test the child VAD in long-term animal studies and freeze its design for future preclinical GLP studies. Meanwhile, we will develop the infant VAD and complete its short-term animal studies. PUBLIC HEALTH RELEVANCE: To date, the need of long-term circulatory support for infant and child with congenital and acquired cardiovascular disease has largely been unmet. The goal of the proposed project is to develop two innovative circulatory support systems for children and infants based upon the unique proprietary and patented CircuLite Synergy Pocket Circulatory Assist Device. The success of these two devices will potentially benefit thousands of infants and children with congenital and acquired cardiovascular disease who otherwise would die each year in the United States while waiting for a donor heart.

描述（由申请人提供）：现在常规地使用复杂的心室辅助设备（VAD），用于恢复桥，或心力衰竭患者移植的桥梁。但是，由于这些设备的小型化过程中的延迟，VAD在成年人中的应用的成功尚未转化为小儿应用。迄今为止，对于先天性或性心血管疾病的婴儿和儿童的VAD的需求在很大程度上尚未得到满足。每年在美国等待捐助者心脏时，数百名婴儿和儿童在美国死亡。这种“快速轨道” SBIR应用程序的目的是为婴儿和儿童开发长期可植入的微型vads，这是基于当前循环协同装置的成功而建立的。该协同装置是一种独特的专有和专利的微型VAD。在经过十年的发展中，它已被完善，是最小的可植入血泵，仅是“ AA”电池的大小。该设备目前正在欧洲进行CE Mark试验，并在USFDA IDE提交中进行。第一阶段项目的目的是证明儿童使用当前的循环微泵（1.5-3 l/min流）（5-35 kg），通过修改设备的入口外壳进行左心室的顶端插入，而II期项目可以进一步改善微型泵的可靠性，以进一步改善Impelling的可行性，或者重新定位不合时宜的型号，以重新启动Immigning immigning impellere nimpellere sige the Impellere nimpelle nimpellere sige apepals inmigne nimpelle siper的可行性。 0.3-1.5 l/min用于婴儿（<5 kg）。第一阶段项目的里程碑将是经过短期动物研究的儿童VAD的交付。在第二阶段，我们将进一步测试长期动物研究中的儿童VAD，并将其设计冻结以进行未来的临床前GLP研究。同时，我们将开发婴儿VAD并完成其短期动物研究。公共卫生相关性：迄今为止，需要长期循环系统支持对先天性和后疾病的心血管疾病的儿童，这在很大程度上尚未得到满足。拟议项目的目的是根据独特的专有和专利的循环协同式循环循环辅助设备为儿童和婴儿开发两个创新的循环支持系统。这两种设备的成功可能会使成千上万的婴儿和先天性患有心血管疾病的儿童受益，否则他们每年在美国等待捐助者心脏而死。