Compact Membraneless Device for Hemodialysis

这项研究的长期目标是开发一种新的终末期肾病(ESRD)治疗方案--一种基于新的微流体概念的紧凑、可穿戴的人工肾脏。这种设备将在低流速下长时间提供治疗，极大地减少体液中的浓度和体积瞬变；它还可以消除对抗凝剂的需求。关键部件是主分离器，它能够将水和溶质从血液输送到类似血浆的溶液(鞘液体)中，而不需要使用 薄膜。鞘液将这些化合物带到二次分离器，在那里它们通过膜转移到外部透析液进行处理。二次分离器类似于传统的膜透析器或血液透析过滤器，但实质上更小。它只作用于鞘流体，除去水和溶质，并将纯化的鞘流体循环到初级分离器。 拟议设备的初级分离器的基本可行性将在这个快速通道项目的第一阶段中得到验证，展示了足够的血细胞限制和到次级(鞘)流体的分子传输。在第二阶段，将开发一系列原型系统，包括兼容的主要和次要分离器，并同时进行临床测试。 患有终末期肾病的患者在不接受治疗的情况下死亡。ESRD的年治疗成本接近100亿美元，市场估计表明，几乎90%的患者接受血液透析治疗。这里建议的设备将服务于该市场的一部分，当摆脱了治疗方案和门诊透析的缺陷时，可以更充分地恢复

The long-term goal of this research is development of a new treatment option for end-stage renal disease (ESRD) - a compact, wearable artificial kidney based on a new microfluidic concept. This device will provide treatment at low flow rates over long times, greatly reducing concentration and volume transient in body fluids; it may also obviate the need for anticoagulants. The key element is a primary separator that enables transport of water and solutes from the blood to a plasma-like solution (sheath fluid) without the use of a membrane. The sheath fluid carries these compounds to a secondary separator where they are transferred across a membrane to an external dialysate for disposal. The secondary separator is similar to a conventional membrane hemodialyzer or hemodiafilter, but is substantially smaller. It acts only on the sheath fluid to remove water and solutes and recycle purified sheath fluid to the primary separator. The fundamental feasibility of the primary separator of the proposed device will be proven in Phase I of this Fast-Track project, demonstrating adequate blood-cell confinement and molecular transport to a secondary (sheath) fluid. In Phase II, a succession of prototype systems comprising compatible primary and secondary separators will be developed and concurrent clinical tests performed. Patients who suffer from ESRD die without treatment. Annual costs for treatment of ESRD approach $10 billion, and market estimates indicate that almost 90% of patients are treated by hemodialysis. The device proposed here will serve the portion of that market that can be much more fully rehabilitated when freed from the regimen and deficiencies of in-clinic dialysis