Labtype to Preclinical Prototype VAD

描述(由申请人提供)：灌流解决方案公司(PSI)已经从克利夫兰诊所获得了“MiniMixedFlow”(M2F)泵技术的许可。这一Fast-Track SBIR应用旨在克服重大商业投资的剩余障碍，从而获得临床使用资格。申请专利的配置采用了被动磁力轴承、微型电机和混流叶轮，以制造一种耐用的泵，相对于其尺寸具有高输出。配置极为灵活，适应性极强。已经建立了解决多个临床利基市场的硬件原型。出色的试验台结果和非常初步的活体数据已经通过使用快捷方式构建的“Labtype”硬件获得，从而能够快速评估最基本的设计问题。到目前为止，硬件已经显示出良好的水力性能、低溶血性、非常长的寿命和初步的体内结果，受到实验室计划所需建造快捷方式的影响。剩下的关键可行性问题是在慢性植入条件下免于沉积/血栓事件。PSI建议使用改进的结构和精加工技术建立一个临床前原型泵。在这个快速通道方案的第一阶段，我们将证明：1)前临床硬件保持了初步硬件的基本性能和溶血结果；2)在新耐力测试系列的早期阶段，耐用性相对于实验室类型没有变化；以及3)在两项为期30天的体内研究中显示出良好的生物兼容性。(1)和(2)的成功标准是与实验室类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是否有血栓栓塞症并发症来判断。随着NIH项目官员接受第一阶段的结果，第二阶段将建造更多的泵硬件和临床前原型控制台，启动扩展的体内演示研究，并继续进行工作台耐力测试。有了这些数据，为筹集重大第三阶段商业投资而需要克服的最后一个障碍将被打破。 公共卫生相关性：心脏病是死亡率、生活质量下降和高昂的治疗医疗费用的主要来源。血泵已经显示出不仅可以拯救生命，而且可以使患者恢复到更高水平的功能的潜力。然而，目前的技术 仍然有大量的限制，这些限制导致泵植入导致死亡和残疾；拟议的项目解决了其中许多限制。

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.