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.

皮下超级输注装置（squid）是一种半永久性的经皮，具有30,000 m.w.位于皮肤下并将药物分配到皮下组织的截止膜。毛细管滤液收集器（CFC）是一种类似的膜集合，在真空下，它会产生与血浆相同浓度的葡萄糖浓度的超滤。在初步研究中，我们使用基于磁带的系统来测量CFC流体上的葡萄糖测量，该滚筒泵将胰岛素注入鱿鱼，并创建了连续反馈控制的胰岛素输注系统（FII系统），然后用链蛋白酶诱导的糖尿病在大鼠中测试，该系统在大鼠中进行了测试。在该项目的第一阶段，我们将实际组合CFC和鱿鱼设备，以包括单个经皮管，并放大胰岛素输注组件（使用最小的507泵）。然后，我们将进一步测试系统以控制糖尿病大鼠的血糖。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，并使用此测量实现FII系统。该系统将允许开发小型，整体且潜在可穿戴的FII系统。拟议的商业应用：胰岛素泵已用于糖尿病患者使用的糖尿病患者，他们希望密切控制葡萄糖水平，现在在美国有50,000多名患者，大多数患者将选择一种半永久性的鱿鱼装置来证明其安全且有效，如果它可以安全有效地使用一个月或更长的时间，而不是每隔几天放置新的针刺或导管。如果被证明是安全有效的话，还有更多的人会佩戴带有类似耐用的访问装置的反馈控制的胰岛素输注系统。鱿鱼装置还具有许多其他医疗状况的治疗，其中需要连续药物治疗，包括癌症，肝炎，慢性疼痛和荷尔蒙缺乏症。