Wearable Device for Continuous Hemodialysis

产品说明：该计划的基本目标是开发一种基于微流体的人工肾，最大限度地减少血液暴露于人工表面，并在紧凑的可穿戴设备中提供连续灌注。该装置将在低流速下长时间提供治疗，大大降低体液中的浓度和体积瞬变。关键元件是一个初级分离器，它能够将水和溶质从血液输送到血浆样溶液（鞘液）。鞘液将这些化合物携带到二级分离器，在二级分离器中，这些化合物被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。该系统的性质允许大部分组件（初级和次级分离器）在尺寸约为60 cm 3的小包装中佩戴。到目前为止，我们已经证明了初级和次级分离器的基本参数，并开始设计其他系统部件。我们与商业合作伙伴密切合作，并将此提案作为已确定的相关医疗器械系列中首个产品的直接开发途径。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，我们将准备申请完整临床试验的IDE。 公共卫生相关性：终末期肾病（ESRD）的标准治疗是透析。每年用于治疗ESRD的临床费用接近100亿美元，市场估计表明几乎90%的患者通过血液透析治疗。然而，血液透析远非完美的解决方案，因为它需要每周去诊所三次，并且会让患者在治疗前和治疗后的大部分时间内感到不适。我们的设备将能够在治疗之间维持容量，并最终取代临床治疗，通过在许多小时内提供缓慢治疗而不是每周几次相对较短的治疗来改善患者的生活质量。通过消除频繁的诊所访问的需要，患者更能够过上正常的生活。总之，本文提出的器械将服务于该市场的一部分，当摆脱临床透析的方案和缺陷时，该市场可以得到更充分的恢复。

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. PUBLIC HEALTH RELEVANCE: Standard treatment for End Stage Renal Disease (ESRD) is dialysis. Annual clinical costs for treatment of ESRD approach $10 billion, and market estimates indicate that almost 90% of patients are treated by hemodialysis. Hemodialysis, however, is far from a perfect solution, in that it requires thrice-weekly visits to a clinic, and leaves the patient feeling ill for a good portion of the time prior and immediately following these treatments. Our device will enable the maintenance of volume between treatments, and eventually replace clinical treatments, improving patient quality of life by virtue of providing slow treatment over many hours instead of a few relatively short sessions a week. By eliminating the need for frequent clinic visits, the patient is more able to lead a normal life. In summary, 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.