Development of a Pediatric Ventricular Assist Device

具体目标是完成一种可靠的、生物兼容的儿科循环支持装置的开发，称为PediaFlow，为心力衰竭3公斤至15公斤的高危儿童提供长达6个月的必要循环支持。该装置的目的是完全植入单一的小口径经皮导线，将包括基于智能传感器的控制器和专门设计的套管组，并将抗凝限制为抗血小板药物。该装置将在该计划的最后两年被植入动物模型，并在第五年开始正式的可靠性研究。 可用于治疗先天性和获得性心脏病患者心力衰竭的选择非常有限，这促使了这一RFP应用的发展。我们的提案代表了一个由匹兹堡大学(UOP)、匹兹堡儿童医院(CHP)、MedQuest和Magic Moments LLC组成的财团，总体目标是开发一种高度可靠、生物兼容的脑室辅助装置，用于3公斤至15公斤的独特和高危人群(从出生到两岁的患者)的长期支持(6个月)。我们将开发的创新PVAD是基于具有磁悬浮功能的微型离心泵，以确保最大限度地减少血液损伤和血栓形成的风险。 我们的儿科脑室辅助装置(PVAD)的临床设计要求包括： -完全植入一个单一的小口径经皮导线，穿过皮肤进行能量和数据传输； -适合长达六(6)个月的持续支持； -抗凝要求仅限于抗血小板药物(如果临床指征，可选择使用Coumadin)； -将包括一个基于“智能”传感器的血流动力学控制器，以持续监测心脏状态，以满足潜在的“桥向恢复”应用。我们的控制器还将持续监控PVAD的性能，并产生可编程幅度和频率的流量脉冲； -将包括特别设计的适合RV和LV支持的儿科套管组。 我们提出了一个多学科计划，利用我们在开发机械循环支持设备方面的多年工业经验，以及我们在心血管生物工程(例如计算分析、流动可视化、控制理论、电磁学)和相关科学(生物兼容性、免疫学和生物流变学)方面的集体专业知识，应用于VAD患者、成人和儿童患者的心血管生理学和临床脑室辅助。 在RFP计划的最后两年，计划使用密封的PVAD系统进行12个体内植入。四项最终的活体研究将利用妊娠羔羊作为我们提议的患者群体的解剖学/生理学模型。三个双心室支持植入试验也计划与四个延长(六个月)的LV植入一起进行。我们相信，在为期5年的RFP计划结束时，我们的PVAD系统将准备开始正式的可靠性鉴定。

The specific aim is to complete the development of a reliable and biocompatible pediatric circulatory support device, known as the PediaFlow, to provide needed circulatory support for up to six months in the high-risk population of children with heart failure between 3 kg and 15 kg. The device is intended to be fully implantable with a single, small caliber percutaneous lead, will include a smart sensor-based controller and specially-designed cannulae sets, and will limit anticoagulation to anti-platelet medications. The device will be implanted in an animal model during the final two years of the program and begin formal reliability studies in the fifth year. The very limited options available to treat ventricular failure in patients with congenital and acquired heart diseases have motivated the development of this RFP application. Our proposal represents a consortium consisting of the University of Pittsburgh (UOP), Children's Hospital of Pittsburgh (CHP), MedQuest¿ and Magnetic Moments, LLC with the overall aim of developing a highly reliable, biocompatible ventricular assist device for chronic support (6 months) of the unique and high-risk population of children between 3 kg and 15 kg (patients from birth to two years of age). The innovative PVAD we will develop is based on a miniature centrifugal flow pump featuring magnetic levitation, to assure minimal blood trauma and risk of thrombosis. Clinical design requirements for Our pediatric ventricular assist device (PVAD) include: -fully implantable with a single, small caliber percutaneous lead crossing the skin for energy and data transmission; -suitable for up to six (6) months continuous support; -anticoagulation requirement limited to anti-platelet medications (with the option for Coumadin if clinically indicated); -a "smart" sensor-based hemodynamic controller will be included to continuously monitor cardiac status for potential "bridge-to-recovery" applications. Our controller will also continuously monitor the performance of the PVAD and produce a flow pulse of programmable amplitude and frequency; -specially-designed pediatric cannulae sets suitable for both RV and LV support will be included. A multi-disciplinary program is proposed which capitalizes on our years of industrial experience in developing mechanical circulatory support devices, plus our collective expertise in cardiovascular bioengineering (e.g., computational analyses, flow visualization, control theory, electromagnetics), and related sciences (biocompatibility, immunology, and biorheology) as applied to V AD patients, cardiovascular physiology and clinical ventricular assistance for adult and pediatric patients. During the final two years of the RFP Program, 12 in vivo implants are planned using hermetically sealed PVAD systems. Four of the final in vivo studies will utilize perigestational lambs as a model of the anatomy/physiology of our proposed patient population. Three biventricular support implant trials are also planned along with four extended (six month) LV implants. We believe that our PVAD system will be ready to begin formal reliability qualification at the end of the 5-year RFP program.