Implantable Ventricular Assist Device Directed to Long Term Right Side Support

 描述(由申请人提供)：对于桥接和目的地应用，LVAD的使用都在增加，但对右室辅助的需求是显而易见的，即使在被选择来避免这种并发症的患者中也是如此。当需求明显时，这些患者通常接受临时右室辅助装置(RVAD)和短暂的外部泵，尽管手术前计划的双室植入物的存活率更高。困难在于缺乏用于RVAD的良好的植入性系统。现有的适应这种用途的植入式左冠状动脉旁路转移泵为右侧使用带来了重大的妥协。灌流解决方案公司开发了一种被动磁轴承泵(“M2F”)，该泵已在多种尺寸中进行了演示。最广泛开发的10 mm泵非常适合作为植入式长期RVAD。它很小，但会为肺循环产生强大的流量和压力。磁轴承对速度不敏感，因此，如果心室恢复，泵可以设置为低速，但如果肺阻力或心功能出现新的问题，泵仍可正常工作。该几何图形与每个单独病例约束的灵活植入方法兼容。溶血率非常低，可能是由于大的、低剪切的磁轴承间隙所致。该泵已显示出多年的耐用性。该项目的创新之处在于提供了第一个临床可植入RVAD，它不需要做出重大妥协即可适应应用。关于将M2F LVAD转换为RVAD应用的技术问题并不具有挑战性。可行性问题是作为RVAD植入物的生物相容性。初步的可行性将通过两个没有血栓问题的小腿植入物来证明。第一阶段的具体目标是：(1)设计解剖上和生物上兼容的RVAD流入和流出套管；(2)制造两个M2F RVAD泵；(3)试验台性能和溶血测试；(4)两个14天的活体RVAD植入物。在第二阶段，我们将再建造8个系统。将增加台架试验数据库。持续时间更长的植入物将作为BiVAD进行，在第二阶段提案和授予时适当地将PSI系统与商业上可用的LVAD相结合。这将展示第一个临床可用的产品，优于目前或在不久的将来提供的任何产品，并导致利用临床经验开发完全集成的BiVAD系统。PSI是一家克利夫兰诊所的衍生公司。在这个项目中，它与诊所的考夫曼心力衰竭中心和心血管动力学实验室合作，以满足对令人满意的RVAD系统的迫切需求。

 DESCRIPTION (provided by applicant): LVAD use is increasing for both bridge and destination applications, but the need for right ventricular assist is apparent, even in patients selected to avoid this complication. These patients usually receive a temporary right ventricular assist device (RVAD) with a short-lived, external pump when the need becomes apparent, although the survival rate is superior with a pre-operatively planned biventricular implant. The difficulty is a paucity of good implantable systems for RVAD use. Existing implantable LVAD pumps adapted to this use bring with them significant compromises for right sided use. Perfusion Solutions has developed a passive magnetic bearing pump (the "M2F") that has been demonstrated in multiple sizes. The most extensively developed 10 mm pump is well-suited as an implanted, long-term RVAD. It is very small but produces strong flow and pressure for the pulmonary circulation. The magnetic bearing is not speed sensitive so the pump can be set to slow speed if the ventricle recovers but remain functional if there is a renewed issue with pulmonary resistance or ventricular function. The geometry is compatible with flexible implant approaches per individual case constraints. Hemolysis is extraordinarily low, perhaps due to the large, low shear magnetic bearing clearances. The pump has shown multi-year durability. The innovation of this project is the provision of the first clinical implantable RVAD which does not require major compromises to adapt to the application. The technical issues with respect to conversion of the M2F LVAD for RVAD applications are not challenging. The feasibility issue is biocompatibility as an RVAD implant. Initial feasibility will be demonstrated by two calf implants without thrombus issues. The specific aims for phase I are: (1) design of anatomically compatible and biocompatible RVAD inflow and outflow cannulae; (2) fabrication of two M2F RVAD pumps; (3) bench performance and hemolysis testing; and (4) two, 14-day in vivo RVAD implants. During Phase II, we will build 8 more systems. The database of bench testing will be increased. Longer duration implants will be performed as BiVAD's, combining the PSI system with a commercially available LVAD as appropriate at the time of the phase II proposal and award. This will demonstrate a first clinically usable product superior to anything now available or becoming available in the near future and lead into development of a fully integrated BiVAD system utilizing the clinical experience. PSI is a Cleveland Clinic spin-off company. In this project, it is teamed with the Clinic's Kaufman Heart Failure Center and Cardiovascular Dynamics Laboratory to meet the pressing need for a satisfactory RVAD system.