Device for Eradicting & Controlling Biofilm in Dialysis

描述（由申请人提供）： 血液透析是一种水密集型治疗，其提出了一个巨大的挑战，即成本有效地生产非常大量的高纯度水。透析液中细菌和内毒素的出现可追溯到透析水系统中与水接触的表面上生长的生物膜。目前的液体循环维持方法不能从透析水系统中去除生物膜，因此不能消除透析水的生物污染的主要来源。这些方法繁琐、劳动密集、耗时且成本高。我们建议使用两相流清洁技术，该技术已被证明可从狭长通道中去除生物膜，以根除生物膜并控制其在透析水系统中的增殖。本研究的具体目的是：1）定义并构建模拟透析单元水系统，以模仿透析诊所的实际水系统; 2）定义从透析单元水系统的管道中去除生物膜所需的两相流过程的流动和流体动力学参数; 3）使用标准微生物学方法优化和验证透析单元水系统的两阶段清洁/消毒工艺方案;以及4）定义在II期研究期间在临床环境中应用于透析单元的系统要求。第一阶段的研究将集中在清洁和消除反渗透水和水系统的碳酸氢盐溶液回路的生物膜。这种方法提供了一种生产和维持高质量血液透析治疗用水的基本新方法。

DESCRIPTION (provided by applicant): Hemodialysis is a water intensive therapy that presents an enormous challenge to cost effectively produce very large amounts of high purity water. The occurrence of bacteria and endotoxins in dialysis fluids is traced to biofilm that grows at surfaces in contact with water in dialysis water systems. Current liquid circulation maintenance methods are not capable of removing biofilm from dialysis water systems, and thus are incapable of eliminating the main source of biological contamination of dialysis water. Such methods are tedious, labor-intensive, time-consuming and costly. We propose to use a two-phase flow cleaning technology proven to remove biofilm from long and narrow passageways to eradicate biofilm and control its proliferation in dialysis water systems. The specific aims of the study are: 1) To define and build a simulated dialysis unit water system mimicking an actual water system at a dialysis clinic; 2) To define flow and fluid dynamics parameters of the two-phase flow process necessary to remove biofilm from pipelines of dialysis unit water systems; 3) To optimize and validate the two-phase cleaning/disinfection process protocol for a dialysis unit water system using standard microbiology methods; and 4) To define system requirements to be applied at the dialysis units in the clinical setting during the Phase II study. The Phase I study will focus on cleaning and eradicating biofilm from RO water and bicarbonate solution loops of the water system. This approach presents a cardinal new means of producing and maintaining high quality water for use in hemodialysis treatment.