NOVEL ACCESSORY FOR URINARY LEG BAGS

在康复中心或医院，被称为腿袋的尿引流袋通常与永久留置导尿管一起用于失禁或慢性残疾的患者。腿袋通常是导致尿路感染的上升感染的三个主要来源之一。（另外两个切入点是导管-腿袋连接处和导管-皮肤连接处）。据报道，经常用漂白剂、双氧水等消毒腿袋，可大大减少感染事件。我们建议制造一个实验原型，一个便宜的附加配件，将被安置在腿袋和Foley之间（而不是1/4”）。目前使用乳胶管)。该配件由抗菌弹性体制成，旨在为排尿提供高表面接触，并在此过程中将FDA批准的抗菌剂（非抗生素）浸出到腿袋中。配件的内壁也会阻止微生物从袋子迁移到Foley。（提供初步数据）。该材料具有生物相容性。第一阶段将使用连接到导管的腿袋的“体外”模型进行演示，有或没有拟议的附件，并使用P.mirabilis-E挑战腿袋。大肠杆菌混合培养，模拟上升感染。在为期15天的时间内，将获得微生物分析、生物膜和pH值变化的统计数据。该配件有望以较低的成本为患者提供高质量的护理，并显著减少传染性微生物对环境的污染。建议的商业应用：1992年，北美的泌尿生殖装置数量相当可观。据报道，约有16亿个尿失禁垫和设备，1600万个导尿管和580亿个尿布被使用。（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20%的腿包用户使用我们的配件，那么至少存在一个销售大约100万个配件的市场。

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.