Active Mixing Membrane Oxygenator Phase II

描述（由申请人提供）：Ension，Inc.及其发展伙伴， 匹兹堡大学，已经开发并申请了一种主动混合 膜式氧合器（AMMO），已被证明是高效的， 充氧和脱碳条件（目前氧合器的5-8倍 在使用中），能够泵送血液并且对血液无损伤。AMMO实现了 通过旋转微孔中空纤维的流通盘来提高其效率 膜，其安装在双腔轴上，通过血液 显著地最小化流体相阻力。体外和体内数据 被收集来证实我们声称的高效传质， 以最小的血液损伤泵血。 我们提出的第二阶段计划包括改进目前的AMMO设计， 提供至少7.0 Lpm的血流和充足的气体输送、氧气 在装置中，400 ml/min的转移和250 ml/min的二氧化碳转移 0.5 sq. M.纤维表面积这些能力应足以 在心脏直视手术中支持成年患者。 制造方法将从开发实验室转移到 半自动化的制造过程，这将使生产高 数量足以支持MMI全面评价的优质器械 标准 小牛体内试验（每年12头）将从以下急性试验开始： 改进设备，并根据当前FDA的指导方针进行实验。 最后，建议在Yr.在我们的 最终原型和这些数据，以及第三阶段产生的数据 提交给FDA，以支持我们的器械就绪声明 进行人体临床试验 拟定商业应用： 膜式氧合器仍然是心肺旁路手术的金标准。每年进行大约1，000，000次心脏直视手术。每个操作还需要某种类型的泵送装置。AMMO已被证明在气体传输方面非常有效，并且还执行泵送功能。它的生产成本应该不会超过目前的氧合器。这个市场每年的销售额约为4亿美元。AMMO将获得巨大的市场份额。

DESCRIPTION (provided by applicant): Ension, Inc. and its development partner, the University of Pittsburgh, have developed and patented an active mixing membrane oxygenator (AMMO), which has been proven to be highly efficient in terms of oxygenation and decarbonation (5-8 times that of oxygenators currently in use), capable of pumping blood and atraumatic to blood. The AMMO achieves its efficiency by rotating flow-through discs of microporous hollow fiber membranes, which are mounted on a double lumen shaft, through blood significantly minimizing fluid phase resistance. In vitro and in vivo data have been collected to substantiate our claims of highly efficient mass transfer and blood pumping with minimal blood damage. Our proposed Phase II plan includes refinement of current AMMO designs to provide at least 7.0 Lpm of blood flow and adequate gas transfer, oxygen transfer of 400 ml/min and carbon dioxide transfer of 250 ml/min, in a device with 0.5 sq. m. fiber surface area. These capabilities should be sufficient to support adult patients during open-heart surgery. Fabrication methods will be moved from the development laboratory to a semi-automated manufacturing process that will enable the production of high quality devices in numbers adequate to support full evaluation per MMI standards. In vivo testing in calves (12 per year) will commence with acute testing of improved devices and move to experiments that follow current FDA guidelines. Finally, it is proposed that 6 animal experiments in Yr. 02 be conducted on our final prototype and this data, in addition to that generated in the Phase III development, be submitted to the FDA to support our claim of device readiness for a human clinical trial. PROPOSED COMMERCIAL APPLICATION: Membrane oxygenators remain as the gold standard for heart lung bypass procedures. Approximately 1,000,000 open heart procedures are performed each year. Each operation also requires some type of pumping device. AMMO has been shown to be highly efficient at gas transfer and performs the pumping function as well. It should cost no more to produce than current oxygenators. This market represents about $400 million in sales per year. AMMO should garner significant market share.