NOVEL ACCESSORY FOR URINARY LEG BAGS

新型尿腿袋配件

• 批准号: 2865251
• 负责人: SHANTHA s SARANGAPANI
• 金额: $ 9.86万
• 依托单位: INNOVATIVE CHEMICAL/ENVIRONMENTAL TECH
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-05-01 至 1999-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2865251
• 关键词: Escherichia coli; antiinfective agents; biomedical equipment development; clinical biomedical equipment; disease /disorder prevention /control; elastomers; fluid flow; molecular film; urinary catheterization; urinary incontinence; urinary tract infection

Urinary drainage bags called leg bags are commonly used with permanent indwelling catheters in patients, with incontinence or chronic disabilities, at rehabilitation centers or hospitals. The leg bags are frequently one of the major three sources for an ascending infection that causes UTI in patients. (The other two points of entry are the catheter-leg bag connection and the catheter-skin junction). Frequent disinfection of the leg bags with bleach, hydrogen peroxide etc. have been reported to reduce the infection incidents dramatically. We propose to fabricate an experimental prototype, an inexpensive add-on accessory that will be housed between the leg bag and the Foley (instead of the 1/4". latex tubing used currently). This accessory is made of an antimicrobial elastomer designed to provide a high surface contact for the draining urine and in that process leach FDA approved antimicrobials (not antibiotics) into the leg bags. The inner walls of the accessory would also block the migration of the microorganisms into the Foley from the bags. (Preliminary data presented). The proposed material is biocompatible. The phase I will demonstrate using an "invitro" model of leg bags connected to catheters, with and without the proposed accessory and challenging the leg bags with P.mirabilis-E.coli mixed culture, to mimic ascending infection. Statistical data on the microbiological assays, biofilms and pH changes will be obtained for a period of 15 days. This accessory is expected to provide quality care to the patients at a low cost to the provider and significantly reduce environmental contamination by the infectious organisms. PROPOSED COMMERCIAL APPLICATIONS: In 1992 the number of urogenital devices in North America was substantial. About 1.6 billion incontinence pads and devices, 16 million catheters and 58 billion diapers were reportedly used. (Reid, 1994 J. of industrial microbiology, 13 90-96) As the senior population grows this problem is becoming more common. We believe if our accessories are used by 20% of the leg bag users, a market of about a sale of at least million accessories exists.

称为腿袋的导尿袋通常在康复中心或医院与失禁或慢性残疾患者的永久留置导尿管一起使用。腿袋通常是导致患者尿路感染的上行感染的三大来源之一。 （另外两个入口点是导管-腿袋连接处和导管-皮肤连接处）。据报道，经常用漂白剂、过氧化氢等对腿袋进行消毒可以大大减少感染事件。我们建议制作一个实验原型，这是一种廉价的附加配件，将安装在腿袋和 Foley 之间（而不是目前使用的 1/4" 乳胶管）。该配件由抗菌弹性体制成，旨在为排出尿液提供高表面接触，并在此过程中将 FDA 批准的抗菌剂（而非抗生素）浸入腿袋中。配件的内壁也会阻止微生物从袋子迁移到 Foley 中。所提出的材料具有生物相容性，第一阶段将演示使用连接到导管的腿袋模型，无论是否有所提出的附件，并用奇异变形杆菌-大肠杆菌混合培养物挑战腿袋，以模拟上行感染，将获得为期 15 天的微生物检测、生物膜和 pH 变化的统计数据，预计该附件将以较低的成本为患者提供优质护理，并显着减少环境污染。传染性生物体。拟议的商业应用： 1992 年，北美泌尿生殖设备的数量相当可观。据报道，使用了约 16 亿个失禁垫和装置、1600 万根导尿管和 580 亿片尿布。 （Reid，1994 J. of Industrial Microbiology，13 90-96）随着老年人口的增长，这个问题变得越来越普遍。我们相信，如果我们的配件被20%的腿包用户使用，那么就存在一个至少销售百万个配件的市场。