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

皮下超滤输注装置（SQUID）是一种半永久性经皮装置，具有30,000毫瓦特的切断膜，位于皮肤下并将药物分配到皮下组织。毛细管滤液收集器（CFC）是一种类似的膜集合，在真空下产生具有与血浆相同浓度葡萄糖的超滤液。在初步研究中，我们使用了基于胶带的系统来测量CFC液体的葡萄糖测量，使用滚轴泵向SQUID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中进行了测试。在这个项目的第一阶段，我们将物理结合CFC和SQUID设备，包括一个经皮管，并放大胰岛素输注成分（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，我们将通过使用葡萄糖氧化酶电极来测量CFC滤液中的葡萄糖水平来简化葡萄糖测量系统，并使用该测量实现FII系统。该系统将允许FII系统的开发，这是一个小，整体和潜在的可穿戴。建议的商业应用：胰岛素泵在需要严密控制血糖水平的糖尿病患者中的使用越来越多，目前在美国有超过5万名患者，其中大多数患者会选择半永久性的SQUID设备进行胰岛素输注，如果它被证明是安全有效的，使用一个月或更长时间，而不是每隔几天放置新的针头或导管。如果证明安全有效，更多的人会佩戴反馈控制的胰岛素输注系统，该系统具有类似的耐用访问装置。SQUID装置还具有治疗许多其他需要持续药物治疗的疾病的潜力，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.