Wearable Device for Continuous Hemodialysis

描述：这个项目的基本目标是开发一种基于微流体的人工肾脏，它可以最大限度地减少血液暴露在人造表面，并在一个紧凑的可穿戴设备中提供持续的灌注。该设备可以长时间以低流速进行治疗，大大降低体液中的浓度和体积。关键部件是一个主要的分离器，使水和溶质从血液输送到类似血浆的溶液（鞘液）。鞘液将这些化合物携带到二级分离器，在那里它们被转移到外部透析液中进行处理。二级分离器类似于传统的膜式血液透析器或血液滤过器，但体积要小得多。它仅作用于护套液以去除水和溶质，并将净化后的护套液再循环到主分离器。该系统的性质允许大部分组件（主分离器和次级分离器）安装在一个大约60立方厘米的小包装中。到目前为止，我们已经演示了主分离器和次级分离器的基本参数，并开始设计其他系统组件。我们已经与一个商业合作伙伴密切合作，并提出了这一建议，作为确定的相关医疗设备系列中第一个产品的直接开发路径。在拟议的II期项目中，我们将完成系统所有组件的设计并进行初步测试，以便在II期项目结束时，我们将准备申请IDE进行完整的临床试验。

DESCRIPTION: The fundamental goal of this program is to develop a microfluidics-based artificial kidney that minimizes exposure of blood to artificial surfaces and provides continuous perfusion in a compact, wearable device. This device will provide treatment at low flow rates over long times, greatly reducing concentration and volume transient in body fluids. The key element is a primary separator that enables transport of water and solutes from the blood to a plasma-like solution (sheath fluid). The sheath fluid carries these compounds to a secondary separator where they are transferred 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 nature of the system allows the majority of the components (the primary and secondary separators) to be worn in a small package approximately 60 cm3 in size. Thus far we have demonstrated the essential parameters of the primary and secondary separators and begun the design of other system components. We have worked closely with a commercial partner and present this proposal as a direct development path to the first product in an identified family of related medical devices. In the proposed Phase II program, we will finalize the design of all components of the system and perform preliminary testing such that by the end of the Phase II program we will be prepared to apply for an IDE for full clinical trials.