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.

在康复中心或医院，尿失禁或慢性残疾患者通常使用称为腿袋的尿引流袋与永久留置导管一起使用。腿袋通常是导致患者UTI的上行感染的三个主要来源之一。(The其它两个进入点是导管-腿袋连接和导管-皮肤连接）。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”）。目前使用的乳胶管）。该附件由抗菌弹性体制成，旨在为引流尿液提供高表面接触，并在此过程中将FDA批准的抗菌剂（非抗生素）滤入腿袋。附件的内壁也会阻止微生物从袋迁移到Foley中。（提供初步数据）。申报材料具有生物相容性。第I阶段将使用连接到导管的腿袋的“体外”模型进行证明，使用和不使用申报附件，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15天内微生物测定、生物膜和pH值变化的统计数据。该附件有望以较低的成本为患者提供高质量的护理，并显著减少感染性生物体对环境的污染。拟议的商业应用：1992年，北美的泌尿生殖装置数量相当可观。据报道，大约使用了16亿个失禁垫和设备，1600万个导管和580亿个尿布。(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%的腿袋用户使用，一个大约销售至少有100万配件的市场存在。