GLUCOSE ENZYME ELECTRODE SUITABLE FOR IMPLANTATION

该应用程序请求支持，以完成长期的开发 植入式皮下葡萄糖传感器，有史以来第一次实现。 一期 研究已经导致了专有膜材料的开发， 在低氧张力下提供长期信号稳定性和线性 （30-80 mm Hg）和宽葡萄糖浓度（40-400 mg/dl）环境下的 皮下组织 这些膜的固定化酶活性 材料在大鼠腹腔内体内植入后存活 一年多了 这些膜已经压配在 电化学传感器，耦合到无线电发射器，并植入到 狗的皮下组织 静脉输注葡萄糖或胰岛素后 传感器每次适当地跟踪葡萄糖数月。 这 皮下传感器响应滞后血糖响应 大约8分钟。 第二阶段将完善，优化和微型化这个原型传感器。 更 具体地，传感器/组织界面将被更好地限定， 在组织学上以及在增加血管生成所起的作用方面， 因子 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地封装。 制造系统 该传感器及其部件将得到进一步开发和验证。 监管机构的审批流程将从获取以下数据开始开始： 性能、可靠性和寿命。 III期人类受试者试验是 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.