High Efficiency Dialyzer Development - Phase 2

高效透析器开发 - 第 2 阶段

• 批准号: 7070035
• 负责人: Mark Gartner
• 金额: $ 40.67万
• 依托单位: ENSION, INC.
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-06-01 至 2009-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7070035
• 关键词: artificial membranes; biomaterial development /preparation; biomaterial evaluation; biomedical equipment development; blood oxygenator; circulatory assist; cow; hemodialysis; physical property

DESCRIPTION (provided by applicant): Hemodialysis is currently required by more than 200,000 Americans with this number expected to climb significantly in the next decade. During each dialysis session, only a portion of the waste products normally eliminated by the kidneys is actually removed. The subject device of this research proposal is designed to be more efficient than current dialyzer units and at the same time present smaller foreign surface area to minimize deleterious blood-biomaterial interactions. The long-term object of this research is to complete the development of a highly efficient hemodialyzer, Renal Flow. This device achieves its high efficiency through the use of active mixing whereby the dialyzer element is rotated within the blood environment to minimize fluid phase resistance resulting in increased mass transfer efficiency. This rotational motion also imparts energy to the blood which could obviate the need for a separate blood pump as currently required by dialysis machines. Increased efficiency and elimination of unnecessary components should allow for more complete removal of waste products while minimizing the amount of blood contacting surface area. In Phase II, we propose to increase our fabrication efficiency and yield by injection molding components, developing new methods of fiber array production, utilizing clean room production, and automating device fabrication. In addition, we propose to integrate the RenalFlow controller into a clinically available dialysis console. Multiple prototypes using various fiber types, fiber densities, and surface areas will be constructed in Year 1 and evaluated. The most promising design will then be optimized and fully characterized in Year 02. Comprehensive in vitro and ex vivo evaluations are an integral part of this program. We propose to use bovine blood in vitro for mass transfer calculations and calves with chronic hemodialysis shunts for multiple RenalFlow biocompatibility evaluations. Dialyzer cartridges will be reprocessed per current clinical practice to mimic actual use.

描述(由申请人提供)： 目前有20多万美国人需要血液透析，预计这一数字在未来十年将大幅攀升。在每次透析过程中，只有一部分通常由肾脏排出的废物实际被清除。本研究方案的主题装置被设计为比目前的透析器单元更有效，同时提供更小的异物表面积，以最大限度地减少有害的血液-生物材料相互作用。 本研究的长期目标是完成一种高效血液透析器--Renal Flow的开发。该设备通过使用主动混合来实现其高效率，即透析器元件在血液环境中旋转，以最小化流体相阻力，从而提高传质效率。这种旋转运动还为血液提供能量，这可以消除目前透析机所需的单独血泵的需要。更高的效率和消除不必要的成分应该允许更完全地清除废物，同时最大限度地减少血液接触表面积的量。 在第二阶段，我们建议通过注塑组件、开发光纤阵列生产的新方法、利用无尘室生产和自动化设备制造来提高我们的制造效率和产量。此外，我们建议将RenalFlow控制器集成到临床可用的透析控制台中。 使用不同纤维类型、纤维密度和表面积的多个原型将在第一年建造并进行评估。然后，最有希望的设计将在公元02年进行优化和充分表征。 全面的体外和体外评估是该计划不可或缺的一部分。我们建议使用体外牛血进行传质计算，并使用具有慢性血液透析分流的小牛进行多个RenalFlow生物相容性评估。透析器墨盒将根据当前的临床实践进行再处理，以模拟实际使用。