A NOVEL ACCESSORY FOR URINARY LEGBAGS

尿尿腿袋的新颖配件

• 批准号: 6381559
• 负责人: SHANTHA s SARANGAPANI
• 金额: $ 38.31万
• 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 2004-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6381559
• 关键词: Escherichia coli; antiinfective agents; biomaterial development /preparation; biomaterial evaluation; biomedical equipment development; clinical biomedical equipment; clinical research; clinical trials; disease /disorder prevention /control; elastomers; human subject; laboratory rabbit; molecular film; urinary catheterization; urinary incontinence; urinary tract infection

The phase I effort on the testing and performance of a biocidal device (Foley Guard) placed between the catheters and urinary leg bags to prevent ascending infections from leg bags into the urinary catheters was successfully completed. An in vitro apparatus mimicking a catheterized bladder with infected leg bags was used. A multi channel pump and manifolds allowed comparison between the controls and the experimental devices under the same conditions. The addition of a biocidal device as an accessory to the leg bags resulted in the complete absence of any microorganisms near the catheter base for over 10-14 days, which was the duration of the experiment. All of the corresponding controls showed high levels of the bacteria near the catheter base within 3-9 days. These in vitro tests suggest a useful role for the device in controlling infection in patients undergoing short and long term indwelling catheterization. A continuous challenge of three pathogens in human urine medium, showed that for up to 30 days the materials inhibited all the bacteria completely. The broad-spectrum activities of the phase I biocidal material used in this Foley guard has been well established by the PI. (toward bacteria, mold, and candida-type yeast species). A two week rabbit- muscle implantation study of the biocidal material resulted in a non-toxic response. The phase II will optimize the formulation and the manufacturing protocols. A series of microbiological tests using the strains from catheterized patients will be performed to assess: the biocidal potency per unit weight of the material, the potency before and after extensive washing in synthetic urine and the bactericidal activity and the longevity of the device under in vitro conditions. The biocide release concentrations will be established firmly for our claims. Finally, human clinical trials will be conducted to establish the efficacy and performance and compared to controls. 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) Estimates of the cost of treating catheter-related UTI have ranged as high as $39,960 per patient per year including the increase in nursing care required. 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 at least million accessories exists.

放置在导管和尿腿袋之间以防止从尿腿袋进入导尿管的上行感染的生物杀灭装置（Foley Guard）的测试和性能的I期工作已成功完成。使用模拟带有感染腿袋的插管膀胱的体外装置。多通道泵和歧管允许在相同条件下对控制装置和实验装置进行比较。在腿袋中添加生物杀灭装置作为附件，导致导管基部附近完全没有任何微生物超过10-14天，这是实验的持续时间。所有相应的对照组均在3-9天内显示导管底座附近有高水平的细菌。这些体外试验表明，该器械在控制接受短期和长期留置导管插入术患者的感染方面具有有用的作用。在人尿培养基中连续挑战三种病原体，表明材料可完全抑制所有细菌长达30天。PI已充分确立了该Foley防护装置中使用的I期生物杀灭材料的广谱活性。（针对细菌、霉菌和念珠菌型酵母菌）。杀生物材料的两周兔肌肉植入研究导致无毒反应。第二阶段将优化配方和生产方案。将使用来自插管患者的菌株进行一系列微生物学试验，以评估：每单位重量材料的杀菌效力、在合成尿液中广泛洗涤前后的效力以及体外条件下器械的杀菌活性和寿命。将为我们的声明确定杀生物剂释放浓度。最后，将进行人体临床试验，以确定疗效和性能，并与对照品进行比较。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）治疗导管相关UTI的费用估计高达每位患者每年39，960美元，包括所需护理的增加。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，市场至少有100万配件存在。