A NOVEL ACCESSORY FOR URINARY LEGBAGS

放置在导尿管和尿腿袋之间的生物杀灭装置（Foley Guard）的测试和性能的第一阶段工作已成功完成，该装置可防止尿腿袋进入导尿管的上升感染。我们使用了一种体外装置，模拟带感染腿袋的导尿膀胱。多通道泵和歧管允许在相同条件下的控制和实验设备之间进行比较。在腿袋上增加一个生物杀灭装置作为附件，导致导管底座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。所有相应的对照组在3-9天内都在导管底部附近出现高水平的细菌。这些体外试验表明，该装置在控制短期和长期留置导管患者感染方面发挥了有益的作用。在人类尿液培养基中连续挑战三种病原体，表明该材料可以完全抑制所有细菌长达30天。该福利防护中使用的I相生物杀灭材料的广谱活性已被PI很好地确定。（针对细菌、霉菌和念珠菌型酵母菌）。在为期两周的兔子肌肉植入研究中，这种生物杀灭材料产生了无毒反应。第二阶段将优化配方和生产工艺。将使用导尿患者的菌株进行一系列微生物试验，以评估：每单位重量材料的杀菌效力，在合成尿液中大量洗涤前后的效力，以及体外条件下装置的杀菌活性和寿命。杀菌剂的释放浓度将会为我们的主张建立牢固的基础。最后，将进行人体临床试验，以确定疗效和性能，并与对照组进行比较。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）治疗导管相关尿路感染的费用估计高达每位患者每年39,960美元，其中包括所需护理费用的增加。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%的腿包用户使用，那么至少存在一个百万配件市场。

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.