van den Bosch Edith E M, de Bont Nik H M, Qiu Jun, Gelling Onko-Jan
DSM Biomedical, Koestraat 1, 6167 RA Geleen, The Netherlands.
J Diabetes Sci Technol. 2013 Mar 1;7(2):455-64. doi: 10.1177/193229681300700223.
Continuous glucose monitors (CGMs) measure glucose in real time, making it possible to improve glycemic control. A promising technique involves glucose sensors implanted in subcutaneous tissue measuring glucose concentration in interstitial fluid. A major drawback of this technique is sensor bioinstability, which can lead to unpredictable drift and reproducibility. The bioinstability is partly due to sensor design but is also affected by naturally occurring subcutaneous inflammations. Applying a nonbiofouling coating to the sensor membrane could be a means to enhancing sensocompatibility.
This study evaluates the suitability of a polyethylene-glycol-based coating on sensors in CGMs. Methods used include cross hatch, wet paper rub, paper double rub, bending, hydrophilicity, protein adsorption, bio-compatibility, hemocompatibility, and glucose/oxygen permeability testing.
Results demonstrate that coating homogeneity, adhesion, integrity, and scratch resistance are good. The coating repels lysozyme and bovine serum albumin, and only a low level of fibrin and blood platelet adsorption to the coating was recorded when testing in whole human blood. Cytotoxicity, irritation, sensitization, and hemolysis were assessed, and levels suggested good biocompatibility of the coating in subcutaneous tissue. Finally, it was shown that the coating can be applied to cellulose acetate membranes of different porosity without changing their permeability for glucose and oxygen.
These results suggest that the mechanical properties of the coating are sufficient for the given application, that the coating is effective in preventing protein adsorption and blood clot formation on the sensor surface, and that the coating can be applied to membranes without hindering their glucose and oxygen transport.
连续血糖监测仪(CGM)可实时测量血糖,从而有可能改善血糖控制。一种有前景的技术是将葡萄糖传感器植入皮下组织以测量组织间液中的葡萄糖浓度。该技术的一个主要缺点是传感器的生物不稳定性,这可能导致不可预测的漂移和再现性问题。生物不稳定性部分归因于传感器设计,但也受到自然发生的皮下炎症的影响。在传感器膜上应用非生物污损涂层可能是提高传感相容性的一种方法。
本研究评估了基于聚乙二醇的涂层在CGM传感器上的适用性。使用的方法包括划格试验、湿纸摩擦、纸双摩擦、弯曲试验、亲水性测试、蛋白质吸附测试、生物相容性测试、血液相容性测试以及葡萄糖/氧气渗透性测试。
结果表明涂层的均匀性、附着力、完整性和耐刮性良好。该涂层能排斥溶菌酶和牛血清白蛋白,在全血测试中,记录到只有少量纤维蛋白和血小板吸附到涂层上。评估了细胞毒性、刺激性、致敏性和溶血情况,结果表明该涂层在皮下组织中具有良好的生物相容性。最后表明,该涂层可以应用于不同孔隙率的醋酸纤维素膜,而不会改变它们对葡萄糖和氧气的渗透性。
这些结果表明,涂层的机械性能足以满足给定的应用,涂层能有效防止蛋白质吸附和传感器表面形成血栓,并且该涂层可以应用于膜而不妨碍它们对葡萄糖和氧气的传输。