Novel approaches to extending glucose sensor lifespan

描述（由申请人提供）：长期经皮器械，如导管；要求患者忍受延长的皮肤裂口（伤口），这在临床上可能难以处理，即感染和炎症。这些并发症不仅缩短了设备的使用寿命，而且损害了患者的健康。对于短期经皮血糖传感器，FDA已经批准糖尿病患者使用3-7天。虽然这些短期传感器存在感染问题，但将这些传感器的体内寿命从几天延长到几周会增加不良反应的风险。葡萄糖传感器植入部位的不良反应包括感染、刺激、发红、瘙痒和炎症。所有这些不利影响都可以并且确实缩短传感器在体内的使用寿命。所有这些不良影响不仅损害传感器功能，而且阻碍患者参与植入式传感器。显然，降低传感器植入部位的感染和炎症风险不仅可以延长传感器的使用寿命，还可以减少相关的并发症和不良事件。在目前的提案中，我们建议开发和验证一些基于水凝胶的传感器项圈和涂层，包括生物增强以提高传感器在体内的寿命。这些传感器项圈和涂层将单独或组合使用，以扩展体内葡萄糖传感器的功能。我们相信这种方法将引领新一代设备/佐剂，不仅可以增强现有商用传感器的功能并延长其使用寿命，还可以延长下一代经皮葡萄糖传感器的使用寿命。

DESCRIPTION (provided by applicant): Long term transcutaneous devices such as catheters; require patients to endure extended skin breaches (wounds) that can be difficult to manage clinically, i.e. infection and inflammation. These complications not only shorten device lifespan, but also compromise patient health. In the case of short-term commercial transcutaneous glucose sensors, FDA has approved their usage for 3-7 days for patients with diabetes. Although infection is an issue with these short-term sensors extending the in vivo lifespan of these sensors from days to weeks increases the risks of adverse effects. Adverse effects seen at sites of glucose sensor implantation include infection, irritation, redness, itching and inflammation. All these adverse effects can and do shorten sensor lifespan in vivo. All these adverse effectives not only compromise sensor function, but also discourage patient involvement in implantable sensors. Clearly, decreasing the risk of infections and inflammation at sensor implantation sites would likely not only increase sensor lifespan, but also decrease associated complications and adverse events. In the present proposal we proposed to develop and validate a number of hydrogel based sensor collars and coatings including one that are bio-enhanced to promote sensor lifespan in vivo. These sensor collars and coatings will be used alone and in combination to extend glucose sensor function in vivo. We believe this approach will usher in a new generation of devices / adjuvants that will enhance the function and extend lifespan of not only existing commercial sensors, but also future generation of trancutaneous glucose sensors. PUBLIC HEALTH RELEVANCE: Increasing the implantation time frame beyond the FDA approved 3-7 days for transcutaneous glucose sensors increases the risk of adverse effects, such as infection, irritation, redness, itching and inflammation, at sites of sensor implantation and as such decreases sensor lifespan in vivo. In order to avoid these adverse effects we propose to develop and validate a number of hydrogel based sensor collars and coatings including one that are bio-enhanced to promote sensor lifespan in vivo.