BIOLOGIC-PD--A NIGHTTIME PERITONEAL CYCLER

该项目的目标是适应现有的单一访问 血液透析机，BioLogic-HD（tm），执行夜间- 高透析液量的腹膜透析时间。 一 这台机器上的一次性包装将包括一个30升的袋子 其包括干燥的预定量的NaCl，NaHCO 3， 葡萄糖和羧基氨基酸。 的控制下 BioLogic机器，30升纯净和无菌水将 添加到这个包。 为了制造纯净无菌的水，一个- 患者用水净化系统HD-100将在 由Water Pure，Inc. 水会通过 颗粒活性炭，0.5微米过滤器，Filmtec（R） 反渗透膜和Minntech聚砜中空 纤维超滤器 在第一阶段，我们将首先修改BioLogic-HD和HD-100 并创建包括30升袋的一次性包装。 然后，我们将这些整合到一个单一的系统中， 通过无菌连接传输流体的连接，以及 通过使用刻度尺测量来监测液体的体积， 生物逻辑 彻底的体外试验将确定无菌性， 透析液的化学成分和温度，以及安全性， 可靠性和灵敏度。 如果这些 测试是肯定的，那么在这个项目的第二阶段，我们将 重点放在必要的步骤，使市场的夜间 可提供透析的腹膜透析机 治疗更有效，时间更少， CAPD。

The goal of this project is to adapt an existent single-access hemodialysis machine, the BioLogic-HD(tm), to perform night- time periotoneal dialysis with high dialysate volumes. A disposable package on this machine will include a 30 liter bag which includes dry premeasured amounts of NaCl, NaHCO3, glucose, and carboxylic amino acids. Under control of the BioLogic machine, 30 liters of pure and sterile water will be added to this bag. To create the pure and sterile water, a single- patient water purification system, the HD-100, will be supplied in modified form by Water Pure, Inc. Water will pass through granular activated charcoal, a 0.5 micron filter, a Filmtec(R) reverse osmosis membrane and a Minntech polysulfone hollow fiber ultrafilter. During Phase I we will first modify the BioLogic-HD and HD-100 and create the disposable package including the 30 liter bag. Then, we will integrate these into a single system with connections to transfer fluid through sterile connections, and monitor the volume of fluid through measurement with a scale in the BioLogic. Thorough in vitro tests will determine the sterility, chemical content, and tempature of the dialysate, and the safety, reliability, and sensitivity of the dialysis delivery system. If these tests are affirmative, then during Phase II of this project, we will focus on steps necessary to bring to market a night-time peritoneal dialysis machine capable of providing dialysis treatments which are more effective and less time-intensive than CAPD.