Nearly 900,000 patients worldwide have end-stage renal disease and require dialysis or kidney transplantation. Despite the availability of these forms of renal replacement therapy for nearly four decades, mortality and morbidity are high and patients often have a poor quality of life. We have developed a human nephron filter (HNF) utilizing nanotechnology that would eventually make feasible a continuously functioning, wearable or implantable artificial kidney. The device consists of two membranes operating in series within one device cartridge. The first membrane mimics the function of the glomerulus, using convective transport to generate a plasma ultrafiltrate containing all solutes approaching the molecular weight of albumin. The second membrane mimics the function of the renal tubules, selectively reclaiming designated solutes to maintain body homeostasis. No dialysis solution is used in this device. The HNF has been computer-modeled, and operating 12 hr per day, 7 days per week the HNF provides the equivalent of 30 mL/min glomerular filtration rate (compared to half that amount for conventional thrice-weekly hemodialysis). Animal studies should begin in the next 1 to 2 years, and clinical trials would then follow 1 to 2 years subsequent. The HNF system, by eliminating dialysate and utilizing a novel membrane system created through applied nanotechnology, represents a breakthrough in renal replacement therapy based on the functioning of native kidneys. The enhanced solute removal and wearable design should substantially improve patient outcomes and quality of life.

译文

全世界有近900,000名患者患有终末期肾脏疾病,需要透析或肾脏移植。尽管使用这些形式的肾脏替代疗法已有近40年的历史,但死亡率和发病率很高,患者的生活质量通常很差。我们已经开发了一种利用纳米技术的人类肾单位过滤器 (HNF),该过滤器最终将使连续功能,可穿戴或可植入的人造肾脏成为可行。该装置由两个膜组成,在一个装置盒内串联运行。第一个膜模拟肾小球的功能,使用对流传输生成包含所有接近白蛋白分子量的溶质的血浆超滤液。第二个膜模仿肾小管的功能,选择性地回收指定的溶质以维持身体稳态。此设备中没有使用透析溶液。HNF已通过计算机建模,每天12小时,每周7天运行,HNF可提供相当于30 mL/min的肾小球滤过率 (相比之下,常规每周三次血液透析的量为该量的一半)。动物研究应在接下来的1至2年内开始,然后在1至2年后进行临床试验。通过消除透析液并利用通过应用纳米技术创建的新型膜系统,HNF系统代表了基于天然肾脏功能的肾脏替代疗法的突破。增强的溶质去除和可穿戴设计应可显着改善患者的预后和生活质量。

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