Development of a Pediatric Ventricular Assist Device

该项目汇集了一支在微型轴流血泵技术的工程、制造、测试和临床应用方面拥有丰富经验的合作者团队。我们将迅速实施Jarik 2000 Hear的戏剧性微型化，并将其应用于儿科患者。在三年内，我们将完成35克10cc血泵的开发和测试，旨在为大约15-25公斤的儿童提供长期支持。在第四年和第五年，我们将开发一种更小的10克3cc血泵，供婴儿和大约3-15公斤的小孩子使用。体重。 Jarvik 2000心脏是从1995年开始由NIH IVAS合同资助的五个LVAD系统中最成功的一个。这一五年计划于1999年圆满完成。我们的合同绩效实现了其主要目标，并在NIH的最终评估中获得了所有类别中的最高分数。在过去的三年里，Jarik 2000已经在美国和欧洲的55名患者身上植入。第一个移植桥在德克萨斯心脏研究所进行了手术，支持了78天，移植成功，三年后恢复良好。首位“终身使用”获奖者已获资助三年，身体状况良好。许多其他患者在接受该设备数年后情况良好。没有一位患者出现轴承故障。发生的少数与设备相关的感染都得到了成功的治疗。已发生一些血栓、血栓栓塞症和溶血，但发生率可接受的低。在手术技术、病人选择和病人管理方面的改进将降低这些并发症的发生率。我们最终预计Jarvik 2000在LVAD和BVAD配置下都能存活10年。 在90年代中期，S，我们开发了Jarvik 2000的儿科原型模型，并在英国牛津进行了长达4个月的动物测试。我们推迟了进一步的工作，因为我们没有资源同时追求成人和儿童模型。从那时起，我们在成人型号的设计和制造方面取得了许多重要进展，直接适用于儿童和婴儿的尺寸。我们建议的儿科设备将不会是精确的缩小版本，将需要新的刀片设计，以满足儿童和婴儿较低的流量和压力要求。我们将利用先进的CFD方法，结合流动可视化和Ex Vivo溶血测试，在这些非常小的泵中实现可接受的低血液损害。 在最初的儿科患者(在第四年)，我们将使用以前符合成人资格的模拟控制系统。到第五年，我们将利用人体工程学完成一个更小的基于微处理器的可编程控制系统，让儿童在成人的监督下穿着它。儿童和婴儿模型将既小巧又多才多艺。它们将被植入正常心脏的四个心腔中的任何一个，并有望通过各种创造性的外科技术来处理各种先天性畸形中的慢性机械左、右或双室支持。解剖学研究以及基于计算机MR的适配模型是这一计划的重要组成部分。 Jarvik Heart，Inc.是一家ISO 9001注册公司，马里兰大学动物实验室获得GLP认证。我们参与中心的临床团队拥有丰富的VAD和移植经验。Jarvik Heart认识到，对于许多从事这一领域工作的公司和学术机构来说，有限的可用资金不足以完成这种规模的计划。我们是小规模的，专注的，高效的，并愿意接受相当大的成本分担来完成这个项目。与成人Jarvik 2000合作的临床机构已经证明，它们有能力在没有外部资金的情况下找到足够的资源来处理临床病例，并将为儿童取得成功。

This program brings together a team of collaborators with extensive experience in engineering, manufacture, testing, and clinical application of miniaturized axial flow blood pump technology. We will rapidly implement dramatic miniaturization of the Jarik 2000 hear and apply it to pediatric patients. Within three years we will complete development and testing of a 35 gram 10cc blood pump designed for long term support in children of approximately 15-25 Kg. In years four and five we wil develop a still smaller 10 gram 3cc blood pump for infants and small children of approximately 3- 15 Kg. body weight. The Jarvik 2000 heart is the most successful of five LVAD systems funded by the NIH IVAS contracts beginning in 1995. That five year program was successfully completed in 1999. Our contract performance accomplished its major goals and received the highest scores possible in all categories in its NIH final evaluation. Over the past three years the Jarik 2000 has been implanted in 55 patients in the United States and Europe. The first bridge to transplant patient was operated at the Texas Heart Institute, was supported for 78 days, was transplanted successfully, and is well three years later. The first "lifetime use" recipient has been supported for three years and remains in excellent health. Many other patients are doing well years after receiving the device. There have been no bearing failures in any patient. The few device related infections that occurred were all successfully treated. Some thrombus, thromboembolism, and hemolysis has occurred, but at an acceptably low incidence. Improvements in surgical technique, patient selection, and patient management will reduce the rate of these complications. We ultimately expect >10 year survivals with the Jarvik 2000 in both LVAD and BVAD configurations. In the mid 90's, we developed a prototype pediatric model of the Jarvik 2000 and animal tested it for up to four months at Oxford, England. We postponed further work on it because we did not have the resources to pursue both an adult and child model. Since then, we have made many important design and manufacturing advances in the adult model that are directly applicable to the child and infant sizes. The pediatric devices we propose will not be exact scale down versions and will require new blade design for the lower flow and pressure requirements of children and infants. We will utilize advanced CFD methods together with flow visualization and Ex Vivo hemolysis testing to achieve acceptably low blood damage in these very small pumps. In the initial pediatric patients (during year 4) we will use the analog control system previously qualified for adults. By year 5 we will complete a much smaller microprocessor based programmable control system with human engineering to allow it to be worn by children with adult supervision. The child and infant models will be both small and versatile. They will be implantable in any of the four chambers of the normal heart, and also are expected to be applicable by various creative surgical techniques to deal with chronic mechanical left, right, or biventricular support in a wide range of congenital anomalies. Anatomic studies as well as a computerized MR based fitting model are an important part of this program. Jarvik Heart, Inc. is an ISO 9001 registered company and the University of Maryland animal lab is GLP qualified. The clinical teams at our participating centers have extensive VAD and transplant experience. Jarvik Heart recognizes that the limited available funds would not be sufficient to complete a program of this scope for many of the companies and academic institutions working in this field. We are small, focused, efficient, and willing to accept considerable cost sharing to complete this program. The clinical institutions working with the adult Jarvik 2000 have demonstrated their ability to find sufficient resources to conduct clinical cases without outside funding, and will succeed for the children.