Wearable Device for Continuous Hemodialysis

用于连续血液透析的可穿戴设备

• 批准号: 8688548
• 负责人: Anna M Galea
• 金额: $ 74.53万
• 依托单位: VIVONICS, INC.
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-08-05 至 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8688548
• 关键词: Wearable; Device; Continuous; Hemodialysis

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.

描述：该项目的基本目标是开发一种基于微流体的人工肾，将血液暴露在人造表面的可能性降至最低，并在紧凑、可穿戴的设备中提供持续灌流。这种设备将在低流速下提供长时间的治疗，大大减少体液中的浓度和体积瞬变。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)。鞘液将这些化合物输送到二次分离器，在那里它们被转移到外部透析液进行处置。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。该系统的性质允许大多数部件(主要和次要隔板)在尺寸约为60 cm3的小包装中穿戴。到目前为止，我们已经演示了一次和二次分离器的基本参数，并开始设计其他系统部件。我们与一家商业合作伙伴密切合作，并将这项提议作为相关医疗器械系列中第一款产品的直接开发途径。在拟议的第二阶段计划中，我们将最终完成系统所有组件的设计，并进行初步测试，以便在第二阶段计划结束时，我们将准备申请集成开发环境进行全面临床试验。