Small blood pumps for small patients

适用于小型患者的小型血泵

• 批准号: 8809082
• 负责人: Trevor Arnoult Snyder
• 金额: $ 300.75万
• 依托单位: VADOVATIONS, INC.
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-02-15 至 2017-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8809082
• 关键词: Acute; Adolescent; Adult; Age; Anatomic Models; Anatomy; Animal Experiments; Animals; Anticoagulants; Anticoagulation; Berlin; Biological Assay; Blood; Blood coagulation; Blood flow; Caliber; Cannulas; Cardiac; Cessation of life; Child; Childhood; Chronic; Clinical; Clinical Trials; Clinical Trials Design; Complication; Congenital Heart Defects; D Cells; Development; Devices; Documentation; Extracorporeal Membrane Oxygenation; FDA approved; Funding; Health; Heart; Heart Diseases; Heart Transplantation; Heart failure; Heart-Assist Devices; Hemolysis; Hemorrhage; Home environment; Hospitals; Hour; Implant; Implantable Pump; In Vitro; Infant; Infection; Left; Length; Liquid substance; Marketing; Measures; Minor; Modeling; Modification; Operative Surgical Procedures; Patient Discharge; Patients; Performance; Phase; Physicians; Preparation; Pump; Readiness; Safety; Sheep; Side; Small Business Innovation Research Grant; Staging; Stroke; Study models; Survival Rate; System; Technology; Testing; Time; Transplantation; Trauma; Ursidae Family; aged; base; biomaterial compatibility; blood pump; commercialization; design; hemodynamics; high risk; improved; in vivo; meetings; neonate; pediatric patients; pressure; prevent; programs; sample fixation; validation studies; ventricular assist device; verification and validation

DESCRIPTION (provided by applicant): Heart failure and congenital heart defects threaten the lives of several thousand children each year. The only FDA-approved long term pediatric heart support device is the Berlin Heart Excor, which is based on 30+ year old technology and is fraught with complications including blood clots forming in the device requiring frequent device replacement. The recipients of this technology are at high risk for strokes, bleeding, and infection and the pumps are driven by a large 220 lb. console, which limits patient mobility and prevents hospital discharge. In spite of these severe limitations, 90% of Excor recipients survive to transplant, although the median duration of support is only 35 days. A safer device would dramatically reduce the complications of support, permit discharge to home, and allow doctors to deploy the technology earlier, before a child reaches the brink of death. VADovations is developing a miniature implantable pump platform, the Revolution, in which minor modifications of 2 components can be implemented to adjust the pump performance to support the right or left side of the heart. The devices are 8 mm in diameter and 50 mm in length, about the size of a 'AAA' battery, compared to the market leading Heartmate II, which is 47 mm in maximum diameter and 95 mm in length, the size of a 'D' cell battery. Our adult Revolution RVAD can safely generate the lower blood rates needed for a pediatric left heart assist device and has demonstrated exceptionally low blood trauma in bench-top studies and during implants in sheep for durations up to one month with no long-term blood thinners. Building upon these promising results, we propose a Fast Track, combined Phase I/II SBIR to re-purpose the Revolution RVAD as a pediatric left heart assist device, the Revolution MINI, for children ages 1 and up. Then we will revise the design to create the Revolution NEO for neonates and infants, aged 0-1, who represent the largest clinical need for pediatric heart support. During Phase I, we will demonstrate the feasibility and efficacy of the MINI for pediatric blood flow rates and pressures during in vitro and short term animal experiments. In Phase II, we will conduct chronic animal implants to evaluate the long-term function, biocompatibility, and durability of the pumps and perform verification and validation studies of the Revolution MINI system to prepare for a US clinical trial. Throughout the program, we will focus considerable efforts on anatomic fit modeling and studies to devise approaches so that these devices can be implanted in the smaller bodies of children, to avoid pumps protruding from the body, as occurs with the paracorporeal Excor. Superior hemocompatibility, smaller size, and the ability to leverage adult system components, combine to produce pediatric heart assist devices that will offer fewer complications, permit patient discharge to home, and be economically viable to revolutionize the treatment of pediatric heart failure.

描述（由申请人提供）：心力衰竭和先天性心脏缺陷威胁着每年数千名儿童的生命。唯一经FDA批准的长期儿科心脏支撑装置是柏林心脏excor，它基于30多年的技术，并充满并发症，包括在设备中形成的血液凝块，需要频繁更换设备。这项技术的接受者有中风，出血和感染的高风险，并且泵由大型220磅的控制台驱动，该控制台限制了患者的活动能力并阻止了医院的出院。尽管存在这些严重的局限性，但仍有90％的Excor受体能够幸存到移植，尽管支持的中位持续时间仅为35天。更安全的装置将大大减少支撑的并发症，允许出院到家，并允许医生在孩子到达死亡的边缘之前，尽早部署该技术。 Vadovations正在开发一个微型植入泵平台，即革命，其中可以实施2个组件的小修改以调整泵的性能以支撑心脏的右侧或左侧。与市场领先的Hextmate II相比，设备的直径为8毫米，长度约为50毫米，大约是“ AAA”电池的大小，最大直径为47 mm，长度为95毫米，大小为“ D”电池电池。我们的成人革命RVAD可以安全地产生儿科左心辅助装置所需的较低的血液率，并且在板凳顶部研究中表现出极低的血液创伤，在植入绵羊期间，长期没有长期血液稀释剂的绵羊植入绵羊。在这些有希望的结果的基础上，我们提出了一个快速的I/II/II期SBIR，将革命RVAD重新点缀为儿科左心助理设备，即革命Mini，适用于1岁及以上的儿童。然后，我们将修改设计，以创建0-1岁的新生儿和婴儿的革命NEO，他们代表了小儿心脏支持的最大临床需求。在第一阶段，我们将证明在体外和短期动物实验期间，Mini在小儿血流和压力方面的可行性和功效。在第二阶段，我们将进行慢性动物植入物，以评估泵的长期功能，生物相容性和耐用性，并对革命迷你系统进行验证和验证研究，以准备美国临床试验。在整个计划中，我们将大量的努力集中在解剖拟合建模上 并研究了设计方法，以便可以将这些装置植入较小的儿童体内，以避免像paracoreal Excor发生的那样从体内伸出的泵。出色的血液相容性，尺寸较小以及利用成人系统组件的能力，结合起来生产小儿心脏辅助设备，可提供更少的并发症，允许患者出院，并在经济上可行，可以彻底改变儿科心力衰竭的治疗。