Development of a Pediatric Ventricular Assist Device

儿童心室辅助装置的开发

• 批准号: 7789047
• 负责人: ROBERT JARVIK
• 金额: $ 43.07万
• 依托单位: JARVIK HEART, INC.
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-03-30 至 2009-03-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7789047
• 关键词: Development; Pediatric; Ventricular; Assist; Device

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.

该计划汇集了一组合作者，在工程，制造，测试和临床应用方面具有丰富的合作经验。我们将迅速实施Jarik 2000的戏剧性小型化，并将其应用于儿科患者。在三年之内，我们将完成35克10cc血泵的开发和测试，该血泵旨在在约15-25公斤的儿童中长期支持。在四年级和五年中，我们将为婴儿和大约3-15公斤的婴儿和小孩开发一个较小的10克3cc血泵。体重。 Jarvik 2000 Heart是从1995年开始由NIH IVAS合同资助的五个LVAD系统中最成功的。该五年计划在1999年成功完成。我们的合同绩效实现了其主要目标，并在其NIH最终评估中获得了所有类别的最高分数。在过去的三年中，JARIK 2000已植入了美国和欧洲的55名患者中。第一批移植患者的桥是在德克萨斯心脏研究所（Texas Heart Institute）操作的，并支持了78天，成功移植了三年后。第一个“终生使用”接收者已经得到了三年的支持，并且健康状况良好。收到该设备后，许多其他患者的状况已经好几年了。任何患者都没有轴承失败。少数与设备相关的感染都已成功治疗。某些血栓，血栓栓塞和溶血发生了，但发病率很低。改进手术技术，患者选择和患者管理将降低这些并发症的速度。我们最终希望在LVAD和BVAD配置中使用Jarvik 2000> 10年的生存。 在90年代中期，我们开发了Jarvik 2000的原型儿科模型，并在英格兰牛津进行了长达四个月的测试。我们推迟了进一步的工作，因为我们没有资源来追求成人和儿童模型。从那以后，我们在成人模型中做出了许多重要的设计和制造业，这些设计和制造业直接适用于儿童和婴儿尺寸。我们提出的小儿设备将不是确切的缩小版本，并且需要新的刀片设计，以应对儿童和婴儿的较低流量和压力要求。我们将利用先进的CFD方法以及流动可视化和离体溶血测试，以在这些非常小的泵中获得可接受的低血液损伤。 在最初的小儿患者（在第4年）中，我们将使用先前有资格成人的模拟控制系统。到5年级，我们将通过人工工程完成一个基于微处理器的可编程控制系统，以允许儿童在成人监督下佩戴。儿童和婴儿模型既小又多才多艺。它们将在正常心脏的四个腔室中植入，也有望通过各种创造性的手术技术适用，以在广泛的先天性异常中处理慢性机械左，右或双室支撑。解剖学研究以及计算机基于MR的拟合模型是该计划的重要组成部分。 Jarvik Heart，Inc。是一家ISO 9001注册公司，马里兰州的动物实验室有GLP资格。我们参与中心的临床团队具有丰富的VAD和移植经验。 Jarvik Heart认识到，有限的可用资金不足以完成该领域的许多公司和学术机构的计划。我们很小，专注，高效，愿意接受大量的成本共享来完成该计划。与成人Jarvik 2000合作的临床机构已经证明了他们能够找到足够的资源来进行临床案例而无需外部资金，并将为儿童取得成功。