Small blood pumps for small patients

项目总结/摘要 心力衰竭和先天性心脏缺陷每年威胁着数千名儿童的生命。的 只有FDA批准的长期儿科心脏支持设备是柏林心脏Excor，它是基于30+ 这是一项长达一年的技术，充满了并发症，包括在设备中形成血块，需要 频繁更换设备。这项技术的接受者中风、出血和 感染和泵由一个220磅的大型控制台驱动，这限制了患者的移动性， 出院尽管有这些严重的限制，90%的Excor受体存活到移植，尽管 支援期的中位数只有35天。一个更安全的设备将大大减少并发症， 支持，允许出院回家，并允许医生在儿童达到 死亡的边缘 VADovations正在开发一种微型植入式泵平台，革命，其中小 可以对2个部件进行修改，以调整泵的性能， 心脏的一侧。这些设备直径8毫米，长50毫米，大约是一个AAA电池的大小， 与市场领先的Heartmate II（最大直径47 mm，长度95 mm）相比， “D”电池的大小。我们的成人革命RVAD可以安全地产生所需的较低的血液速率， 儿童左心辅助装置，并在实验室研究中证明了极低的血液创伤 以及在绵羊体内植入期间长达一个月，没有长期血液稀释剂。 在这些有希望的结果的基础上，我们提出了一个快速通道，结合第一/第二阶段SBIR，以重新定位 Revolution RVAD是一种儿科左心辅助设备，Revolution MINI，适用于1岁及以上儿童。 然后，我们将修改设计，为0-1岁的新生儿和婴儿创造革命NEO，他们代表 儿科心脏支持的最大临床需求。在第一阶段，我们将证明可行性， 体外和短期动物试验期间MINI对儿科血流速度和压力的有效性 实验在第二阶段，我们将进行慢性动物植入，以评估长期功能， 泵的生物相容性和耐久性，并对Revolution进行验证和确认研究 MINI系统准备在美国进行临床试验。在整个计划中，我们将集中相当大的努力， 解剖学拟合建模和研究，以设计方法，使这些设备可以植入较小的 儿童的身体，以避免泵突出的身体，如发生与paracetament Excor。上级 血液相容性、更小的尺寸和利用成人系统组件的能力，结合联合收割机， 儿科心脏辅助设备，将提供更少的并发症，允许患者出院回家， 在经济上是可行的，可以彻底改变小儿心力衰竭的治疗方法。

PROJECT SUMMARY/ABSTRACT 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.