PROTOTYPE INSTRUMENTATION FOR GLUCOSE SENSOR

需要开发可植入的传感器以用于连续 糖尿病患者的血糖监测。我们已经开发出一种可植入的 基于固定化葡萄糖氧化酶与氧气耦合的葡萄糖传感器 电极，并将传感器用作静脉植入物 在狗身上超过100天。我们的葡萄糖传感器目前拥有世界上 作为功能植入物的持续、长期操作的记录 而不需要重新校准。我们也是第一个开发和使用 植入葡萄糖和葡萄糖的植入式遥测和仪器 氧气传感器。 这些成就证明了持续、长期发展的可行性 应用植入式仪器和遥测技术检测血糖 但是有必要开发一个小的仪器包 最终供人类使用。该方案将包括低电流输入 耦合的能够操作传感器的放大器或恒电位器 涉及遥测传输或数据存储和检索设备。为 长期应用，带有遥测的植入式仪器必须 包装在密封的容器中。的原型版本 这些集成设备必须在成本更高之前进行制造和测试 大规模集成制造是合理的。 在这个修订的第一阶段项目中，我们计划(1)开发完整的系统 以及作为电路基础的部件功能规范 设计；(2)设计、建造和测试第一代台式机版本 (3)设计、制造和测试第二代可穿戴设备 系统的版本；以及(4)开发第一代集成 电路芯片原理图并完成第一轮电路性能测试 模拟。这些研究将为芯片制造铺平道路， 与传感器的集成，以及广泛的植入研究 将在第二阶段进行动物实验。 建议的商业应用： 糖尿病的管理消耗了全国卫生保健总额的15% 支出，占医疗保险支出的25%，并负责 巨大的人力资源成本，不计其数。这些成本可以降低 基本上是通过改善血糖控制而实现的 胰岛素替代，通过持续监测血液成为可能 葡萄糖。将在此处设计的仪器和遥测组件 对于传感器的实施来说是必不可少的。有几百万人 患有糖尿病的人可以从中受益。

There is a need for development of implantable sensors for continuous monitoring of glucose in diabetes. We have developed an implantable glucose sensor based on immobilized glucose oxidase coupled to an oxygen electrode and have operated the sensor as an intravenous implant for over 100 days in dogs. Our glucose sensor currently holds the world's record for continuous, long-term operation as a functioning implant without recalibration. We were also the first to develop and use implantable telemetry and instrumentation with implanted glucose and oxygen sensors. These achievements demonstrate the feasibility of continuous, long-term sensing of glucose employing implanted instrumentation and telemetry in animals but it is necessary to develop a small instrumentation package for eventual human use. The package would include low-current input amplifiers or potentiostats capable of operating the sensors, coupled to telemetry transmission or data storage and retrieval devices. For long-term applications, implantable instrumentation with telemetry must be packaged in hermetically sealed containers. Prototype versions of these integrated devices must be built and tested before more costly large-scale integrated fabrication is justified. In this revised Phase I project we plan to (1) develop complete system and component functional specifications to serve as a basis for circuit design; (2) design, build and test a first generation benchtop version of the system; (3) design, build and test a second generation "wearable" version of the system; and (4) develop a first generation integrated circuit chip schematic and complete a first round of circuit performance simulations. These studies will prepare the way for chip fabrication, integration with the sensor, and extensive implantation studies in animals to be carried out in Phase II. PROPOSED COMMERCIAL APPLICATION: The management of diabetes consumes 15% of total national health care expenditures, 25% of MediCare expenditures, and is responsible for an enormous, untold cost in human resources. These costs could be reduced substantially by better blood glucose control resulting from improved insulin replacement, made possible by continuous monitoring of blood glucose. The instrumentation and telemetry package to be designed here is essential for sensor implementation. There are several million people with diabetes who could benefit.