PumpKIN PreClinical

PumpKIN 临床前

• 批准号: 8429227
• 负责人: ROBERT JARVIK
• 金额: $ 237.45万
• 依托单位: JARVIK HEART, INC.
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-01-15 至 2014-01-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8429227
• 关键词: Adult; Animals; Annual Reports; Boston; Caliber; Cardiac; Ceramics; Child; Childhood; Clinical; Clinical Trials; Computer software; Conduct Clinical Trials; Contracts; Country; Development; Devices; Employee; Engineering; Enrollment; Europe; Evaluation; Funding; Future; Heart; Hemolysis; Human Engineering; Implant; Infant; Journals; Laboratory Animals; Life; Longitudinal Studies; Maryland; Measurement; Measures; Mechanics; Medical center; Membrane; Michigan; Microprocessor; Modeling; Motor; Multi-Institutional Clinical Trial; Newborn Infant; Operative Surgical Procedures; Output; Pacemakers; Patients; Pediatric Hospitals; Pennsylvania; Predisposition; Publishing; Pump; Reporting; Safety; Site; Speed; Sterilization; Surgeon; System; Techniques; Testing; Thrombus; Transplantation; United States National Institutes of Health; Universities; Validation; Ventricular; Washington; Welding; Work; base; blood pump; design; experience; feeding; hemodynamics; interest; operation; pre-clinical; programs; research study; seal

The infant size Jarvik 2000 heart is the smallest permanently implantable blood pump developed as part of the NIH Pediatric VAD Program, and to our knowledge, the smallest in the world. At only 10.5mm diameter, 5.2 cm long and 4cc in volume it is small enough to implant in the ventricular apex of 3.5 Kg. newborns yet it has flow capacity over 3L/min - sufficient output for children up to 25 Kg. Animal implants have shown that the pump remains free of thrombus and operates at low power without causing hemolysis. The pump represents a completed design, incorporating all of the requirements for a long term implant, including welded hermetic sealing of the motor stator and rotor magnet, miniature hermetic feed-throughs for the power cables, a very long life ceramic conical bearing design, and pacemaker type high flex life power cables from the external controller to the implanted blood pump. An advanced microprocessor based control system has just been completed, although only the software for the basic functions (speed setting, measured speed, battery remaining, power, display function management via membrane switches) is presently available. This permits basic operation but does not yet implement some of the more advanced functions planned for the future. Jarvik Heart, Inc. is a small company of only 36 employees, but has successfully conducted clinical trials with the adult model Jarvik 2000, has received CE mark approval in Europe, has completed a 63 patient Pilot IDE study, and enrolled 100 of 150 patients in the IDE pivotal bridge to transplant study. The company thus has sufficient experience to sponsor an IDE clinical trial of the infant Jarvik 2000 and to obtain HUD designation and HDE approval. Over the course of the present five year contract we have collaborated successfully with Dr. Griffith's animal laboratory at the University of Maryland, and they will be a major subcontractor if our proposal is funded. Dr. Bartley Griffith, the Co-PI together with Dr. Jarvik, has extensive cardiac surgical experience with numerous mechanical circulatory support devices, and is a pediatric cardiac surgeon as well as an adult surgeon. We have established relationships with major pediatric cardiac surgical centers that have expressed interest in joining an multi-center Clinical Trial to evaluate the pediatric Jarvik2000. These include Dr. William Gaynor (University of Pennsylvania), Dr. Pedro del Nido (Boston Children's Hospital), Dr. Richard Jonas (Washington National Pediatric Center), Dr. Ed Bovie (University of Michigan) and Dr. Marcelo Cardarelli, Dr. Duke Cameron, and Dr. Luca Vricella (University of Maryland & Johns Hopkins). The PIs from each site will comprise an advisory group for the development of our IDE application, and will advise us concerning other clinical matters including surgical technique and patient management.

婴儿尺寸的Jarvik 2000心脏是作为NIH儿科VAD计划的一部分而开发的最小的永久性植入血泵，据我们所知，这是世界上最小的。直径仅为10.5mm，长5.2厘米，体积4cc的体积很小，足以将其植入3.5 kg的心室顶点。新生儿的流量超过3L/min-足以满足25公斤的儿童的足够输出。动物植入物表明该泵保持不含血栓，并以低功率运行而不会引起溶血。该泵代表完整的设计，并包含了长期植入物的所有要求，包括电机定子和转子磁铁的焊接密封密封，用于电源电缆的微型密封式馈送，是非常长的寿命陶瓷圆锥形轴承轴承设计，以及Pacemaker类型的高弹性生命电缆从外部控制器到外部控制器到植入植入的血液泵。尽管目前可用基于基本功能的软件（速度设置，测量速度，电池剩余，电源，通过膜开关的显示功能管理），但基于高级的微处理器控制系统刚刚完成。这允许基本操作，但尚未实施未来计划的一些更高级的功能。 Jarvik Heart，Inc。是一家只有36名员工的小公司，但已成功地与成人模特Jarvik 2000进行了临床试验，在欧洲获得了CE Mark的批准，已完成了一项63名患者试验IDE研究，并在IDE Pivotal Bridge中的150名患者中有100名在移植研究中注入了150名患者。因此，该公司具有足够的经验来赞助婴儿Jarvik 2000的IDE临床试验，并获得HUD名称和HDE批准。在目前的五年合同中，我们与马里兰大学的格里菲斯（Griffith）动物实验室成功合作，如果我们的提议获得资助，它们将成为主要分包商。 Co-Pi和Jarvik博士Bartley Griffith博士拥有丰富的心脏外科经验，并拥有许多机械循环支持设备，并且是儿科心脏外科医生和成人外科医生。我们已经与主要的儿科心脏外科中心建立了关系，他们表示有兴趣加入一项多中心临床试验以评估儿科JARVIK2000。其中包括William Gaynor博士（宾夕法尼亚大学），Pedro del Nido博士（波士顿儿童医院），理查德·乔纳斯（Richard Jonas）博士（华盛顿国家儿科中心），埃德·博维（Ed Bovie）（密歇根大学）和马塞洛·卡德雷尔（Marcelo Cardarelli）博士，杜克·卡梅伦（Duke Cameron）和卢卡·弗里卡（Luca Vricella）博士（Maryland＆Johns of Maryland＆Johns Hopkins）。来自每个站点的PI将包括一个咨询小组，以开发我们的IDE应用程序，并将建议我们就其他临床问题（包括手术技术和患者管理）提供建议。