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: 7560320
• 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/7560320
• 关键词: Area; Back; Blood; Blood Platelets; Blood gas; Cardiopulmonary Bypass; Clinical; Development; Disadvantaged; Drops; Effectiveness; Evaluation; Extracorporeal Membrane Oxygenation; Extravasation; FDA approved; Fiber; Gases; Government; Guidelines; Legal patent; Manufacturer Name; Marketing; Membrane; Membrane Oxygenators; Methods; Oxygenators; Performance; Persons; Phase; Plant Resins; Plasma; Process; Progress Reports; Quality Control; Research Design; Resistance; Risk; Safety; Side; Silicones; Small Business Innovation Research Grant; Steam; Structure; Surface; System; Technology; Testing; Vendor; Work; base; biomaterial compatibility; blood oxygenator; commercialization; cost; design; expectation; hemodynamics; improved; in vivo; meetings; 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（由申请人提供）：Medarray已在SBIR I期和II期成功开发，这是一种新型的硅胶膜中空纤维，用于血氧剂。我们获得专利的有机硅空心纤维具有巨大的商业潜力，可用于长期体外膜氧合（ECMO）以及常规的心肺旁路。由于ECMO可以持续超过1天，因此通常使用致密而不是微孔膜来防止血浆泄漏。 ECMO的首选膜是有机硅的，因为它具有出色的血液兼容性，并且由于没有血浆泄漏的毛孔。在美国，当前唯一被批准用于长期应用的FDA是Medtronic的ECMO氧合。然而，这种螺旋伤口，平片硅胶氧合的设计可以追溯到1963年，并且具有许多缺点，包括血液停滞区域，最小的对流混合，大血接触表面积和高血液动力学耐药性。在美国，缺乏合适的致密膜中空纤维可长期使用，这使美国制造商无法开发更有效的基于空心的长期氧合。我们在第I和II期中的研究表明，我们的硅酮空心纤维的性能优于螺旋伤口硅胶膜，并且与气体转移和血小板趋势中的微孔膜相当。但是，我们的硅胶膜不能像微孔膜一样渗出血浆或严重栓塞气体。此外，我们在为期11天的体内研究中表明，我们的膜可以执行和维持长期心肺支撑的严格性。 Medarray的硅膜中空纤维将使美国和国外的强大ECMO氧合市场竞争者能够。该建议旨在继续开发我们专有的致密膜空心纤维，同时着重于与在临床氧合中实施膜有关的各个方面。具体而言，我们将研究膜材料对FDA指南的安全性，有效性和生物相容性的影响，以最终在临床使用前满足其需求和期望。我们还将严格测试我们在氧合剂中的膜，以进行气体转移性能和长期体内研究中的血栓形成性。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过程，以最终建立与良好的制造实践（GMP）符合良好和受控的过程（GMP）。这项研究和开发工作将导致膜上的长期血液转移，可以取代高度启用的潮气，以替代拟议的既有型号，可替代拟议的偏移。与当前使用的长期膜相比，致命并发症的风险降低。