NOVEL ACCESSORY FOR URINARY LEG BAGS

在康复中心或医院，尿液引流袋被称为腿袋，通常与永久性留置导尿管一起使用，用于大小便失禁或慢性残疾患者。腿袋通常是引起患者尿路感染的上行性感染的三个主要来源之一。(另外两个入口点是导管-腿袋连接和导管-皮肤连接点)。据报道，经常用漂白剂、过氧化氢等对腿袋进行消毒，可以显著减少感染事件。我们建议制造一个实验原型，一个廉价的附加附件，将被安置在腿部袋和福利之间(而不是1/4“)。目前使用的乳胶管)。这种配件由抗菌弹性体制成，旨在为排出的尿液提供高度的表面接触，并在此过程中将FDA批准的抗菌剂(而不是抗生素)浸入腿部袋中。配件的内壁也会阻止微生物从袋子中迁移到福利中。(提供初步数据)。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“体外”腿袋模型，有无建议的附件，并用奇异肺炎杆菌和大肠杆菌的混合培养挑战腿袋，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。预计这种附件将以较低的成本为患者提供高质量的护理，并显著减少感染性微生物对环境的污染。拟议的商业应用：1992年，北美的泌尿生殖系统设备的数量很大。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。(里德，1994年，工业微生物学，1390-96)随着老年人口的增长，这个问题变得越来越普遍。我们相信，如果我们的配饰被20%的腿包用户使用，那么一个至少有100万配饰销售的市场就存在了。

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.