GLUCOSE ENZYME ELECTRODE SUITABLE FOR IMPLANTATION

此应用程序请求支持以完成长期的开发 植入式皮下血糖传感器，有史以来第一次实现。第一阶段 研究导致了专有膜材料的发展，这种膜材料 在低氧压下提供长期的信号稳定性和线性度 (30-80 mm Hg)和较宽的葡萄糖浓度(40-400 mg/dl)环境 皮下组织。这些膜的固定化酶活性 大鼠腹膜腔内植入体内存活的材料 一年多了。这些膜已经压装在一个 电化学传感器，耦合到无线电发射机，并植入 狗的皮下组织。静脉输注葡萄糖或胰岛素时 该传感器一次恰当地跟踪血糖数月。这 皮下感应器的反应滞后于血糖反应 大约8分钟。 第二阶段将改进、优化和微型化这一原型传感器。更多 具体地说，传感器/组织界面将被更好地定义，两者 组织学和血管生成所起的作用 因素。传感器本身及其电源和无线电发射器将 进一步小型化和更好的包装。用于制造的系统 该传感器及其组件将进一步开发和验证。 监管机构审批过程将从获得以下数据开始 性能、可靠性和寿命。第三阶段人体受试者试验 可能在第二阶段的后期阶段开始。

This application requests support to finish the development of long term implantable subcutaneous glucose sensor, the first ever achieved. Phase I research has led to the development of proprietary membrane materials which provide long term signal stability and linearity in the low oxygen tension (30-80 mm Hg) and broad glucose concentration (40-400 mg/dl) environment of subcutaneous tissue. The immobilized enzyme activity of these membrane materials survived in vivo implantation in the peritoneal cavity of rats for over a year. These membranes have been press fitted over an electrochemical sensor, coupled to a radio transmitter, and implanted into the subcutaneous tissue of dogs. Upon IV infusion of glucose or insulin the sensor appropriately tracks glucose for months at a time. This subcutaneous sensor response lags the blood glucose response by approximately 8 minutes. Phase II will refine, optimize, and miniature this prototype sensor. More specifically, the sensor/tissue interface will be better defined, both histologically and in terms of the role played by addition of angiogenesis factor. The sensor itself and its power supply and radio transmitter will be further miniaturized and better packaged. The system for manufacturing this sensor and its components will be further developed and validated. The process of regulatory agency clearance will begin by obtaining data on performance, reliability and longevity. Phase III human subject trials are likely to begin during the latter stages of Phase II.