Compact Membraneless Device for Hemodialysis

这项研究的长期目标是为终末期肾病（ESRD）开发一种新的治疗选择-一种基于新微流体概念的紧凑型可穿戴人工肾。该装置将在低流速下提供长时间治疗，大大降低体液中的浓度和体积瞬变;它还可以减少对抗凝剂的需求。关键元件是初级分离器，其能够将水和溶质从血液运输到血浆样溶液（鞘液），而不使用微流体。 膜的鞘液将这些化合物携带到二级分离器，在二级分离器中，这些化合物通过膜转移到外部透析液中进行处置。二级分离器类似于传统的膜式血液透析器或血液透析滤过器，但实质上更小。它仅作用于鞘液，以除去水和溶质，并将纯化的鞘液再循环至初级分离器。 申报器械一级分离器的基本可行性将在本快速通道项目的I期中得到证明，证明了足够的血细胞限制和分子转运至二级（鞘）液。在第二阶段，将开发一系列原型系统，包括兼容的一级和二级分离器，并同时进行临床试验。 患有ESRD的患者未经治疗而死亡。每年用于治疗ESRD的费用接近100亿美元，市场估计表明几乎90%的患者通过血液透析治疗。这里提出的设备将服务于该市场的一部分，当从临床透析的方案和缺陷中解放出来时，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