SUB-Q ULTRAFILTER/INFUSION DEVICE (SQUID) FOR INSULIN

皮下超滤器输液装置(SQUID)是一种重量为30,000兆瓦的半永久性经皮输液装置。位于皮肤下并将药物分配到皮下组织的隔膜。毛细管滤液收集器是一种类似的膜收集器，它在真空下产生与血浆浓度相同的葡萄糖超滤液。在初步研究中，我们使用基于磁带的系统来测量CFC液中的血糖测量，使用滚柱泵向鱿鱼中注入胰岛素，并创建了一个连续反馈控制的胰岛素输注系统(FII系统)，然后在链脲佐菌素诱导的糖尿病大鼠身上进行了测试。在这个项目的第一阶段，我们将把CFC和SQUID设备物理地结合在一起，包括一个经皮管，并放大胰岛素输注组件(使用Minimed 507泵)。然后，我们将进一步测试该系统对糖尿病大鼠的血糖控制。在第二阶段，我们将简化葡萄糖测量系统，使用葡萄糖氧化酶电极测量CFC滤液中的葡萄糖水平，并使用此测量实施FII系统。该系统将使FII系统的开发成为可能，该系统体积小、集成度高，而且可能可穿戴。拟议的商业应用：胰岛素泵已被越来越多地用于希望密切控制血糖水平的糖尿病患者，目前美国有超过50,000名患者。这些患者中的大多数人会选择半永久性SQUID装置进行胰岛素输注，如果使用一个月或更长时间被证明是安全有效的，而不是每隔几天放置新的针头或导管。更多的人将佩戴反馈控制的胰岛素输注系统，如果被证明是安全有效的，它将带有类似的耐用访问装置。鱿鱼装置还有可能治疗许多其他需要持续药物治疗的疾病，包括癌症、肝炎、慢性疼痛和激素缺乏。

The Subcutaneous Ultrafilter Infusion Device (SQUID) is a semi- permanent transcutaneous device with 30,000 m.w. cutoff membranes which lie under the skin and distribute drugs to the subcutaneous tissue. The Capillary Filtrate Collector (CFC) is a similar collection of membranes which, under vacuum, creates an ultrafiltrate with the same concentration of glucose as plasma. In preliminary studies, we used a tape-based system to measure glucose measurement on CFC fluid, a roller pump to infuse insulin to the SQUID and created a continuous feedback- controlled insulin infusion system (FII system), which was then tested in rats with streptozotocin-induced diabetes. In Phase I of this project, we will physically combined the CFC and SQUID devices to include a single transcutaneous tube and amplify the insulin infusion components (using the Minimed 507 pump). We will then further test the system for control of blood glucose in diabetic rats. In Phase II we will simplify the glucose measurement system by use of a glucose oxidase electrode to measure glucose levels in the CFC filtrate, and implement an FII system using this measurement. This system will allow development of an FII system which is small, integral and potentially wearable. PROPOSED COMMERCIAL APPLICATIONS: Insulin pumps have grown in use for diabetic patients who desire close control of glucose levels, now over 50,000 patients in the U.S. Most of these patients would choose a semi-permanent SQUID device for insulin infusion if it were proven safe and effective for one month of use or more, rather than placing new needles or catheters each few days. Many more would wear a feedback-controlled insulin infusion system with a similarly durable access device, if proven safe and effective. The SQUID device also has potential for treatment of many other medical conditions where continuous drug therapy is necessary including cancer, hepatitis, chronic pain and hormonal deficiencies.