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

SUB-Q 胰岛素超滤/输注装置 (SQUID)

• 批准号: 6020112
• 负责人: STEPHEN R ASH
• 金额: $ 10万
• 依托单位: HEMOCLEANSE, INC
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-09-20 至 2000-03-19
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6020112
• 关键词: artificial endocrine pancreas; biofeedback; biomedical equipment development; blood glucose; diabetes mellitus therapy; drug administration routes; insulin; laboratory rat; patient monitoring device; ultrafiltration

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.

皮下超滤器输注装置（SQUID）是一种半永久性经皮装置，具有30，000 m.w.切断位于皮肤下并将药物分配到皮下组织的膜。毛细管滤液收集器（CFC）是一种类似的膜收集器，在真空下，可产生与血浆浓度相同的葡萄糖超滤液。在初步研究中，我们使用基于胶带的系统来测量CFC流体上的葡萄糖测量值，使用滚子泵来将胰岛素输注到SQUID，并创建连续反馈控制的胰岛素输注系统（PII系统），然后在患有链脲佐菌素诱导的糖尿病的大鼠中测试该系统。在该项目的第一阶段，我们将物理组合CFC和SQUID设备，以包括单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血糖的控制。在第二阶段，我们将通过使用葡萄糖氧化酶电极来简化葡萄糖测量系统，以测量CFC滤液中的葡萄糖水平，并使用该测量来实施FIB系统。该系统将允许开发一种体积小、整体性强且可能可穿戴的FIS系统。拟议的商业应用：胰岛素泵已越来越多地用于希望密切控制血糖水平的糖尿病患者，现在美国有超过50，000名患者，如果使用一个月或更长时间证明安全有效，这些患者中的大多数会选择半永久性SQUID设备进行胰岛素输注，而不是每隔几天放置新的针头或导管。如果证明安全有效，更多人会佩戴反馈控制胰岛素输注系统，并配备类似耐用的接入设备。SQUID设备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症。