DESIGN OPTIMIZATION OF IMPLANTABLE GLUCOSE SENSOR

众所周知，在糖尿病的治疗中需要可植入葡萄糖传感器。我们有一个传感器，显示承诺。一种简单的传感器已被植入狗的静脉内，并已工作了100多天，而不需要重新校准，并有明显的潜力，在更长的时间内运作。我们现在计划开发一种类似的传感器，用于长期植入组织中。传感器设计将通过迭代建模和原型设计方法针对组织应用进行优化，我们拥有丰富的经验。已经确定了用于该应用的设计优化的关键标准，包括：葡萄糖范围、氧气灵敏度和可用性、对葡萄糖和氧气的瞬态响应、传感器尺寸和形状、信号幅度等。几个有前途的传感器设计将进行模拟，比较上述标准的基础上，制造的原型具有必要的组件，以验证模拟结果，并在体外进行测试。第一阶段工作的终点将是：（1）优化和彻底模拟的传感器设计，以及（2）在体外测试的原型传感器，包含最有前途的设计特征。完整的传感器单元，包括电子器件、植入物外壳和生物相容性接口，将在第II阶段进行体内制造和测试。拟议的商业应用：糖尿病的管理消耗了国家卫生保健总支出的15%，医疗保健支出的25%，并承担了巨大的，无法估量的人力资源成本。这些成本可以通过改善胰岛素替代而得到更好的血糖控制来大幅降低，这是通过连续监测血糖而实现的。数百万糖尿病患者可以受益。

There is a well-known need for an implantable glucose sensor in the treatment of diabetes. We have a sensor that shows promise. A simple version of the sensor has been implanted intravenously in dogs and has functioned for more than l00 days without the need for recalibration, and has clear potential for operation over longer periods. We now plan to develop a similar sensor for long-term implantation in tissues. The sensor design will be optimized for tissue application by an iterative modeling and prototyping approach, with which we have extensive experience. Key criteria have been identified for design optimization for this application, including: glucose range, oxygen sensitivity and availability, transient response to glucose and oxygen, sensor size and shape, signal magnitude, and others. Several promising sensor designs will be simulated, compared based on the above criteria, fabricated as prototypes having the essential components necessary to validate simulation results, and tested in vitro. The endpoints of this Phase I effort will be: (l) an optimized and thoroughly simulated sensor design, and (2) a prototype sensor, tested in vitro, incorporating the most promising design features. The complete sensor unit, including electronics, implant housing, and biocompatible interface will be manufactured and tested in vivo in Phase II. PROPOSED COMMERCIAL APPLICATIONS: 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. Several million people with diabetes could benefit.