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.

该项目汇集了一组在小型轴流式血泵技术的工程、制造、测试和临床应用方面具有丰富经验的合作者。我们将迅速实现Jarik 2000 hear的显著小型化，并将其应用于儿科患者。在三年内，我们将完成35克10 cc血泵的开发和测试，该血泵设计用于约15-25公斤儿童的长期支持。在第四年和第五年，我们将开发一种更小的10克3cc血泵，用于婴儿和体重约3- 15公斤的儿童。体重 Jarvik 2000心脏是1995年开始由NIH IVAS合同资助的五个LVAD系统中最成功的。该五年计划于1999年顺利完成。我们的合同履行完成了其主要目标，并在NIH最终评估中获得了所有类别的最高分。在过去的三年中，Jarik 2000已在美国和欧洲的55名患者中植入。第一个移植病人的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。第一个“终身使用”的接受者已经得到了三年的支持，并且保持着良好的健康状况。许多其他患者在接受该设备多年后情况良好。所有患者均未发生关节面失效。发生的少数器械相关感染均得到成功治疗。发生了一些血栓、血栓栓塞和溶血，但发生率较低。手术技术、患者选择和患者管理的改进将降低这些并发症的发生率。我们最终预期Jarvik 2000在LVAD和BVAD配置中的生存期均>10年。 在90年代中期，我们开发了Jarvik 2000的原型儿科模型，并在英国牛津进行了长达四个月的动物试验。我们推迟了关于它的进一步工作，因为我们没有资源同时追求成人和儿童模式。从那时起，我们在成人模型方面取得了许多重要的设计和制造进步，这些进步直接适用于儿童和婴儿尺寸。我们提出的儿科设备将不是精确的缩小版本，需要新的叶片设计，以满足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实现可接受的低血液损伤。 在最初的儿科患者中（在第4年期间），我们将使用先前经鉴定适用于成人的模拟控制系统。到第五年，我们将完成一个更小的基于微处理器的可编程控制系统，并采用人体工程学，使其能够在成人监督下由儿童佩戴。儿童和婴儿型号将是小型和多功能的。它们将被植入正常心脏的四个腔室中的任何一个，并且还有望通过各种创造性的外科技术来应用于处理各种先天性异常中的慢性机械左、右或双心室支持。解剖学研究以及基于计算机化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，马里兰州大学动物实验室通过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，有限的可用资金不足以为在该领域工作的许多公司和学术机构完成这一范围的计划。我们规模小，专注，高效，并愿意接受相当大的成本分担，以完成这一计划。与成人Jarvik 2000合作的临床机构已经证明，他们有能力找到足够的资源，在没有外部资金的情况下进行临床病例，并将在儿童身上取得成功。