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.

第一阶段的努力在导管和尿腿袋之间放置的杀生物设备（Foley Guard）的测试和性能，以防止从腿部袋中升高到尿中导管中上升的感染。使用了模仿带有感染腿袋的导管膀胱的体外设备。多通道泵和歧管允许在相同条件下对控件和实验设备之间进行比较。添加杀菌装置作为腿袋的配件，导致在导管基底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。所有相应的对照在3-9天内均显示出高水平的细菌。这些体外测试表明，该装置在控制短期和长期留置导管插入术的患者中的感染中起了有用的作用。人类尿液培养基中三种病原体的连续挑战表明，最多30天的材料完全抑制了所有细菌。 PI已很好地确定了该Foley Guard中使用的I期杀生物材料的广谱活动。 （朝向细菌，霉菌和念珠菌型酵母菌物种）。为期两周的兔肌肉植入研究，对杀生物材料进行了无毒反应。第二阶段将优化配方和制造方案。将进行一系列使用导管患者菌株的微生物测试，以评估：材料的每单位重量的杀生物效力，合成尿液中广泛洗涤之前和之后的效力，以及杀菌活性以及在体外条件下设备的寿命。将为我们的主张牢固建立生物剂释放浓度。最后，将进行人类临床试验以确立功效和性能并与对照组相比。拟议的商业应用：1992年，北美的泌尿生殖器设备数量很大。据报道，使用了约16亿次失禁垫和装置，1600万个导管和580亿尿布。 （Reid，1994年，工业微生物学J.，13 90-96）估计治疗导管相关的UTI的成本范围高达每年39,960美元，包括需要增加护理护理。随着老年人的发展，这个问题变得越来越普遍。我们相信，如果20％的腿袋使用者使用我们的配件，则至少存在一百万个配件。