Small blood pumps for small patients

心脏衰竭和先天性心脏缺陷每年威胁着数千名儿童的生命。FDA批准的唯一一种长期儿科心脏支持器械是柏林心脏Excor，该器械基于30多年的技术，并且充满了并发症，包括在器械中形成血凝块，需要频繁更换器械。这项技术的接受者中风、出血和感染的风险很高，而泵是由220磅的大机器驱动的。控制台，这限制了患者的移动性，并阻止出院。尽管有这些严重的限制，90%的Excor受体存活到移植，尽管支持的平均持续时间只有35天。更安全的设备将大大减少支持的并发症，允许出院回家，并允许医生在儿童到达死亡边缘之前更早地部署该技术。VADovations正在开发一种微型植入式泵平台Revolution，其中可以对2个组件进行微小修改，以调整泵的性能，以支持心脏的右侧或左侧。这些设备的直径为8 mm，长度为50 mm，大约是“AAA”电池的大小，而市场领先的Heartmate II的最大直径为47 mm，长度为95 mm，是“D "电池的大小。我们的成人Revolution RVAD可以安全地产生儿科左心辅助装置所需的较低的血液速率，并且在实验室研究和绵羊植入过程中表现出极低的血液创伤，持续时间长达一个月，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I/II期SBIR，将Revolution RVAD重新用作1岁及以上儿童的小儿左心辅助装置Revolution MINI。然后，我们将修改设计，为0-1岁的新生儿和婴儿创建Revolution NEO，他们代表了儿科心脏支持的最大临床需求。在第一阶段，我们将在体外和短期动物实验中证明MINI用于儿科血液流速和压力的可行性和有效性。在第二阶段，我们将进行慢性动物植入，以评价泵的长期功能、生物相容性和耐久性，并对Revolution MINI系统进行验证和确认研究，为美国临床试验做准备。在整个计划中，我们将集中相当大的努力解剖适合建模 并研究设计方法，使这些设备可以植入儿童的较小身体，以避免泵从身体突出，如paracetamic Excor所发生的那样。上级血液相容性、更小的尺寸和利用成人系统组件的能力，结合联合收割机生产儿科心脏辅助装置，该装置将提供更少的并发症，允许患者出院回家，并且在经济上可行，以彻底改变儿科心力衰竭的治疗。

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.