Labtype to Preclinical Prototype VAD

灌注解决方案公司（PSI）已从克利夫兰诊所获得“MiniMixedFlow”（M2F）泵技术许可。这项快速通道SBIR申请旨在克服主要商业投资导致临床使用资格的剩余障碍。该专利申请的配置采用无源磁轴承，微型电机和混合流叶轮来构建相对于其尺寸具有高输出的耐用泵。配置非常灵活，适应性强。已经建立了针对多个临床利基的硬件原型。优秀的实验结果和非常初步的体内数据已经获得了“labtype”硬件构建的快捷方式，使最基本的设计问题的快速评估。到目前为止，硬件已经显示出良好的水力性能，低溶血，非常长的寿命和初步的体内结果，受到实验室程序中必要的施工捷径的影响。剩余的关键可行性问题是在慢性植入条件下免于沉积/栓塞事件。PSI建议使用精细的构造和精加工技术构建临床前原型泵。在这个快速通道提案的I期，我们将证明：1)临床前硬件保持初步硬件的基本性能和溶血结果；2)在新的耐久性试验系列的早期阶段，耐久性相对于试验型没有变化；3)良好的生物相容性在两个30天的体内研究中显示。(1)和(2)的成功标准是与实验室型泵的匹配数据进行比较，而(3)将通过泵中没有沉积或泵下游可归因于血栓栓塞并发症来判断。随着NIH项目官员对第一阶段结果的接受，第二阶段将建造更多的泵硬件和临床前原型控制台，启动扩展的体内示范研究，并继续进行台架耐力测试。有了这些数据，为筹集大量第三阶段商业投资而需要克服的最后一个障碍将被打破。

DESCRIPTION (provided by applicant): Perfusion Solutions, Inc. (PSI) has licensed the "MiniMixedFlow" (M2F) pump technology from the Cleveland Clinic. This Fast-Track SBIR application is intended to overcome the remaining obstacles to major commercial investment leading to qualification for clinical use. The patent applied for configuration employs passive magnetic bearings, a miniature motor, and a mixed flow impeller to build a durable pump of high output relative to its size. The configuration is extremely flexible and adaptable. Hardware prototypes addressing multiple clinical niches have been built. Excellent bench results and very preliminary in vivo data have been obtained with "labtype" hardware built with shortcuts to enable expeditious evaluation of the most fundamental design questions. Hardware to date has shown good hydraulic performance, low hemolysis, very long life and preliminary in vivo results, compromised by construction shortcuts necessary in the lab program. The key remaining feasibility issue is freedom from deposition/embolic events under chronic implant conditions. PSI proposes to build a preclinical prototype pump using refined construction and finishing techniques. During phase I of this fast-track proposal, we will demonstrate: 1) that the preclinica hardware maintains the basic performance and hemolysis results of the preliminary hardware; 2) that the durability shows no change relative to the labtype in the early stages of a new endurance test series; and, 3) good biocompatibility is shown in two 30-day in vivo studies. The success criteria for (1) and (2) are comparisons to the matching data of the lab- type pumps, while (3) will be judged by an absence of deposition in the pump or of thromboembolic complications downstream attributable to the pump. With acceptance from the NIH program officer of phase I results, phase II will build more pump hardware and a preclinical prototype console, launch an extended in vivo demonstration study and continue the bench endurance testing. With this data the last barrier to overcome in order to raise significant phase III commercial investment will have been breached. PUBLIC HEALTH RELEVANCE: Heart disease is a major source of mortality, loss of quality of life, and high medical costs for treatment. Blood pumps have shown a potential to not only save lives, but to rehabilitate patients to a much higher level of function. However, present technology still has a significant number of limitations which cause death and disability as a result of the pump implant; the proposed project addresses many of these limitations.