Ash S R, Rainier J B, Zopp W E, Truitt R B, Janle E M, Kissinger P T, Poulos J T
Ash Medical Systems, Inc., West Lafayette, IN 47906.
ASAIO J. 1993 Jul-Sep;39(3):M699-705.
The capillary filtrate collector (CFC) contains 30,000 molecular weight cut-off, hollow fiber ultrafiltration membranes that are placed below the skin. A transcutaneous tube leads to an evacuated glass tube that provides a vacuum to pull ultrafiltrate at 40-60 microliters/hr from blood, through the fibers, and past a sampling port to the glass tube. Long-term (1-6 months) animal and clinical studies have shown that the ultrafiltrate concentration of chemicals such as glucose and a variety of drugs is exactly the same as that of the blood plasma water when the ultrafiltrate is created. In this study, the device was placed in six home monitored diabetics and four in-center hemodialysis diabetic patients. Over the following month, blood glucose concentrations were compared to CFC glucose concentrations. In spite of difficulties in diluting and assaying small samples of filtrate, there was a good correlation between blood and CFC glucose levels. A flow-through enzymatic glucose sensor has been tested and shown to accurately measure glucose in CFC filtrate. When placed in the transcutaneous tubing near the skin, this should allow a small external device to continuously monitor glucose levels in brittle or out of control diabetes with high accuracy and little risk, discomfort, or cost.
毛细血管滤液收集器(CFC)包含截留分子量为30,000的中空纤维超滤膜,这些膜置于皮肤下方。一根经皮管通向一个抽空的玻璃管,该玻璃管提供真空,以每小时40 - 60微升的速度从血液中抽吸超滤液,使其通过纤维,并经过采样端口进入玻璃管。长期(1 - 6个月)的动物和临床研究表明,在产生超滤液时,葡萄糖和多种药物等化学物质在超滤液中的浓度与血浆水的浓度完全相同。在本研究中,该装置被放置在6名居家监测的糖尿病患者和4名中心血液透析糖尿病患者体内。在接下来的一个月里,将血糖浓度与CFC葡萄糖浓度进行了比较。尽管在稀释和检测少量滤液样本方面存在困难,但血液和CFC葡萄糖水平之间仍有良好的相关性。一种流通式酶促葡萄糖传感器已经过测试,并被证明能够准确测量CFC滤液中的葡萄糖。当放置在靠近皮肤的经皮管中时,这应该能使一个小型外部设备以高精度、低风险、低不适且低成本的方式持续监测脆性糖尿病或失控糖尿病患者的血糖水平。