Active Mixing Membrane Oxygenator Phase II

主动混合膜充氧器二期

• 批准号: 6444256
• 负责人: PHILIP LITWAK
• 金额: $ 35.38万
• 依托单位: ENSION, INC.
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-09-29 至 2004-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6444256
• 关键词: bioengineering /biomedical engineering; biomedical equipment development; blood oxygenator; circulatory assist; clinical biomedical equipment; cow; immature animal; method development

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.

描述(申请人提供)：Ension，Inc.及其开发合作伙伴， 匹兹堡大学已经开发出一种活性搅拌器并申请了专利 膜氧合器(AMMO)，已被证明是高效的 充氧和脱碳术语(是目前充氧器的5-8倍 在使用中)，能够泵血并且对血液无损伤。弹药可以达到 旋转微孔中空纤维流通盘的效率 安装在双腔轴上的膜，通过血液 极大地降低了流体相阻力。体外和体内的数据都有 被收集来证实我们关于高效传质和 血液流动，对血液的损害最小。 我们提议的第二阶段计划包括对目前的弹药设计进行改进，以 提供至少7.0LPM的血流量和充足的气体传输、氧气 在一个装置中以400毫升/分钟和250毫升/分钟的二氧化碳传输 0.5平方英尺。M.纤维表面积。这些能力应该足以 在心脏直视手术期间为成年患者提供支持。 制造方法将从开发实验室转移到 半自动的制造工艺，将使生产的高 高质量的设备，其数量足以支持每个MMI的全面评估 标准。 对小牛的体内测试(每年12次)将从急性测试开始 改进设备，并转向遵循FDA当前指导方针的实验。 最后，建议在YR内进行6个动物实验。02在我们的 最终样机和这些数据，以及在第三阶段中产生的数据 开发，提交给FDA，以支持我们关于设备就绪的声明 进行人体临床试验。 建议的商业应用： 膜式氧合器仍然是心肺转流手术的黄金标准。每年大约有100万例心脏直视手术。每一次作业还需要某种类型的抽水装置。弹药已被证明在气体传输方面是高效的，并具有泵送功能。它的生产成本应该不会比目前的氧合器高。这个市场每年的销售额约为4亿美元。弹药应该会获得相当大的市场份额。