Novel approaches to extending glucose sensor lifespan

描述（由申请人提供）：长期经皮器械，如导管;需要患者忍受临床上难以管理的长期皮肤裂口（伤口），即感染和炎症。这些并发症不仅缩短了设备的使用寿命，还损害了患者的健康。在短期商业经皮葡萄糖传感器的情况下，FDA已批准其用于糖尿病患者3-7天。虽然感染是这些短期传感器的一个问题，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。在葡萄糖探头植入部位观察到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能缩短传感器在体内的寿命。所有这些不利影响不仅损害传感器功能，而且还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能增加传感器的使用寿命，还可能减少相关的并发症和不良事件。在本提案中，我们提出开发和验证许多基于水凝胶的传感器项圈和涂层，包括生物增强以促进传感器体内寿命的传感器项圈和涂层。这些传感器套环和涂层将单独使用和组合使用，以扩展体内葡萄糖传感器功能。我们相信，这种方法将带来新一代的设备/佐剂，不仅可以增强现有商业传感器的功能并延长其寿命，还可以延长未来一代经皮葡萄糖传感器的寿命。 公共卫生相关性：将经皮葡萄糖探头的植入时间延长至超过FDA批准的3-7天，会增加探头植入部位的不良反应风险，如感染、刺激、发红、瘙痒和炎症，从而缩短探头的体内寿命。为了避免这些不良影响，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，包括生物增强的传感器寿命。

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.