Development of a Pediatric Ventricular Assist Device

本提案的目的是开发一种儿科VAD（CCF PediPump），其基于磁力轴承支持的旋转动态泵，可为儿科中遇到的所有患者体型提供支持。这种泵的设计特点是没有密封，转子悬浮在磁性轴承上，从而具有极高的耐用性。该泵的第二个独特之处在于其尺寸非常小，约为7 mm X 60 mm，其物理排量小于MicroMed DeBakey或Jarvik 2000轴流式泵的10%，同时保持良好的流量。事实上，该装置能够提供能够支撑成人的压力和流量，远远超过支撑2至25 kg体重范围内的儿童的要求。在目前的形式中，将根据患者体型使用两种包装概念：血管内配置将用于较大的儿童，而血管外配置将用于最小的儿童。由于其体积小，PediPump为长期开发完全植入式系统提供了非常真实的希望，即使是最小的婴儿。此外，该装置适用于右心室支持（RVAD）、左心室支持（LVAD）和双心室支持（BVAD）。该器械具有高耐久性和上级生物相容性，对宿主的影响最小，包括可能存在最小或无抗凝作用、低水平溶血和最小感染风险。针对该系统所描述的单个泵适用于短期支持，同时适用于非卧床慢性循环支持。

The purpose of this proposal is to develop a pediatric VAD (the CCF PediPump) that is based on a magnetic bearing supported, rotary dynamic pump that can provide support for the entire range of patient sizes encountered in pediatrics. The design of this pump features the absence of a seal with suspension of the rotor on magnetic bearings resulting in extremely high durability. A second, unique feature of this pump is its extremely small size measuring approximately 7 mm X 60 mm which imparts less than 10% of the physical displacement of the MicroMed DeBakey or Jarvik 2000 axial fiow pumps while retaining good flow capacity. In fact, the device is capable of providing pressure and flows capable of supporting adults, far exceeding requirements for support of children in the 2 to 25 kg weight range. In its present form, two packaging concepts wil be used based on patient size: an intravascuiar configuration will be used for older children while an extravascular configuration will be used for the smallest children. Because of its small size the PediPump provides the very real hope for long-term development of a totally implantable system for even the smallest infants. Further, this device is suitable for right ventricular support (RVAD), left ventricular support (LVAD) and biventricular support (BVAD). This device has high durability and superior biocompatibility with minimal host impact, including the potential for minimal or no anticoagulation, low levels of hemolysis and minimal infection risk. A single pump as described for this system is suitable for short-term support while being adaptable to ambulatory chronic circulatory support.