High Efficiency Dialyzer Development - Phase 2

高效透析器开发 - 第 2 阶段

• 批准号: 6934712
• 负责人: Mark Gartner
• 金额: $ 41.86万
• 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 2007-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6934712
• 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）： 目前有超过20万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上被清除。本研究提案的申报器械设计为比当前透析器装置更有效，同时具有更小的异物表面积，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高效血液透析器Renal Flow的开发。该装置通过使用主动混合来实现其高效率，由此透析器元件在血液环境内旋转以使流体相阻力最小化，从而导致质量传递效率增加。这种旋转运动还将能量传递给血液，这可能会减少对透析机目前所需的单独血泵的需要。提高效率和消除不必要的组件应允许更完全地去除废物，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，利用洁净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。 使用各种纤维类型、纤维密度和表面积的多个原型将在第1年构建并进行评估。最有前途的设计将在02年进行优化和充分表征。 全面的体外和离体评价是该计划的组成部分。我们建议使用体外牛血进行传质计算，并使用长期血液透析分流器进行多项RenalFlow生物相容性评价。将按照当前临床实践对透析器滤芯进行再处理，以模拟实际使用。