Novel Dense Hollow Fiber for Blood Gas Exchange

用于血气交换的新型致密中空纤维

• 批准号: 7395179
• 负责人: Jean Montoya
• 金额: $ 100万
• 依托单位: MEDARRAY, INC.
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-02-15 至 2011-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7395179
• 关键词: Area; Back; Blood; Blood Platelets; Blood gas; Cardiopulmonary Bypass; Clinical; Development; Disadvantaged; Drops; Effectiveness; Evaluation; Extracorporeal Membrane Oxygenation; Extravasation; Fiber; Gases; Government; Guidelines; Legal patent; Manufacturer Name; Marketing; Membrane; Membrane Oxygenators; Methods; Oxygenators; Performance; Persons; Phase; Plant Resins; Plasma; Process; Progress Reports; Purpose; Quality Control; Research Design; Resistance; Risk; Safety; Side; Silicones; Small Business Funding Mechanisms; Small Business Innovation Research Grant; Steam; Structure; Surface; System; Technology; Testing; United States Food and Drug Administration; Vendor; Work; base; biomaterial compatibility; blood oxygenator; commercialization; cost; day; design; expectation; hemodynamics; improved; in vivo; novel; pressure; prevent; purge; research and development; scale up; tool; trend; wound

DESCRIPTION (provided by applicant): MedArray has successfully developed under SBIR Phase I and II, a novel silicone membrane hollow fiber for use in blood oxygenators. Our patented silicone hollow fiber has great commercial potential for use in long term extracorporeal membrane oxygenation (ECMO) as well as routine cardiopulmonary bypass. Because ECMO can last more than 1 day, dense rather than microporous membranes are typically used to prevent plasma leakage. The membrane of choice for ECMO is silicone because of its excellent blood compatibility, and because it has no pores for plasma leakage. In the US, the only oxygenator currently FDA approved for use in long term applications is Medtronic's ECMO oxygenator. However, this spiral wound, flat sheet silicone oxygenator's design dates back to 1963, and has many disadvantages including areas of blood stagnation, minimal convective mixing, large blood contact surface areas, and high hemodynamic resistance. The lack of a suitable dense membrane hollow fiber for long term use in the US has prevented US manufacturers from developing a more efficient hollow fiber based long term oxygenator. Our studies in Phase I and II have shown that our silicone hollow fibers' performance is superior to the spiral wound silicone membranes, and comparable to microporous membranes in gas transfer and platelet trends. However, our silicone membrane cannot leak plasma or grossly embolize gas into the blood side like microporous membranes. Moreover, we have shown in an 11-day in-vivo study that our membrane can perform and sustain the rigors of long- term cardiorespiratory support. MedArray's silicone membrane hollow fiber will enable a strong ECMO oxygenator market contender in the US and abroad. This proposal is aimed at continuing the development of our proprietary dense membrane hollow fiber while focusing on all aspects relevant to implementing our membrane in clinical oxygenators. Specifically, we will investigate the effects of membrane materials on safety, effectiveness, and biocompatibility following FDA guidelines to ultimately meet their requirements and expectations prior to clinical use. We will also rigorously test our membrane in oxygenators for gas transfers performance, and thrombogenicity in long-term in-vivo studies. Finally, we will continue refining our membrane fabrication processes by assessing the parameters pertinent to quality control and cost reduction to ultimately establish a robust and controlled process compliant with good manufacturing practices (GMP).This research and development work will result in a membrane for long-term blood-gas transfer that can replace current membrane technology dating back to 1963. The proposed membrane will enable the manufacture of highly efficient blood oxygenators with superior gas transfer, and reduced risk of deadly complications compared to currently used long term membranes.

描述（申请人提供）：MedArray 已在 SBIR I 期和 II 期成功开发出一种用于血液氧合器的新型硅酮膜中空纤维。我们获得专利的有机硅中空纤维在长期体外膜肺氧合 (ECMO) 以及常规体外循环中具有巨大的商业潜力。由于 ECMO 可以持续超过 1 天，因此通常使用致密膜而不是微孔膜来防止血浆渗漏。 ECMO 选择的膜是硅胶，因为它具有出色的血液相容性，并且没有导致血浆渗漏的孔隙。在美国，目前 FDA 批准长期使用的唯一氧合器是美敦力 (Medtronic) 的 ECMO 氧合器。然而，这种螺旋缠绕式平板硅胶氧合器的设计可以追溯到 1963 年，具有许多缺点，包括血液停滞区域、对流混合最小、血液接触表面积大和血流动力学阻力高。由于美国缺乏适合长期使用的致密膜中空纤维，美国制造商无法开发更高效的基于中空纤维的长期充氧器。我们的第一期和第二期研究表明，我们的有机硅中空纤维的性能优于螺旋缠绕有机硅膜，并且在气体传输和血小板趋势方面与微孔膜相当。然而，我们的硅胶膜不能像微孔膜那样泄漏血浆或将气体严重栓塞到血液侧。此外，我们在为期 11 天的体内研究中表明，我们的膜可以执行并维持长期心肺支持的严格要求。 MedArray 的硅膜中空纤维将使 ECMO 氧合器市场成为美国及海外市场的有力竞争者。该提案旨在继续开发我们专有的致密膜中空纤维，同时重点关注与在临床氧合器中实施我们的膜相关的所有方面。具体来说，我们将按照 FDA 指南研究膜材料对安全性、有效性和生物相容性的影响，以最终满足临床使用前的要求和期望。我们还将在长期体内研究中严格测试氧合器中的膜的气体传输性能和血栓形成性。最后，我们将通过评估与质量控制和降低成本相关的参数来继续完善我们的膜制造工艺，以最终建立符合良好生产规范 (GMP) 的稳健且受控的工艺。这项研究和开发工作将产生长期有效的膜长期血气传输可以取代当前可追溯到 1963 年的膜技术。与目前使用的长期膜相比，所提出的膜将能够制造具有卓越气体传输的高效血液氧合器，并降低致命并发症的风险。