Non-coating anti-microbial, anti-host protein deposition, anti-inflammatory urinary catheter

无涂层抗菌、抗宿主蛋白沉积、抗炎导尿管

• 批准号: 10697567
• 负责人: Marc D. Hein
• 金额: $ 32.5万
• 依托单位: HALOMINE, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-06-05 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10697567
• 关键词: Address; Adhesions; Adopted; Adsorption; Anti-Bacterial Agents; Anti-Inflammatory Agents; Antimicrobial Resistance; Attention; Automobile Driving; Awareness; Biocide; Bladder Control; Categories; Catheters; Chemistry; Clinical Trials; Complex; Deposition; Development; Effectiveness; Electrostatics; Event; Generations; Health; Human; Hydration status; Hydrogels; In Vitro; Infection; Infection Control; Inflammation; Learning; Manufacturer; Market Research; Measurable; Medical Care Costs; Methods; Microbe; Microbial Biofilms; Modeling; Mus; Outcome; Patients; Phase; Plant Resins; Polymers; Prevention; Primary Health Care; Proliferating; Proteins; Reaction; Recording of previous events; Research; Research Personnel; Resistance; Risk; Route; Rubber; Safety; Silicon; Silicone Elastomers; Silicones; Silver; Skilled Nursing Facilities; Surface; Technology; Testing; Thick; Toxic effect; Tube; Uropathogen; Water; absorption; antimicrobial; antimicrobial drug; biomaterial compatibility; catheter associated UTI; commercial application; copolymer; cost; cost effective; dosage; drug resistant pathogen; healthcare-associated infections; immunoreaction; in vivo; in vivo evaluation; invention; irritation; microorganism; monomer; next generation; pathogen; prevent; safety testing; success; urinary

Abstract: Catheter-associated urinary tract infection (CAUTI) is the most common type of healthcare-associated infection, however currently there is no effective technology to address the problem. Antimicrobial (anti-biofilm) functionality on the catheter surface is an important field that has gained a lot of attention; however, commercial applications are limited due to a lack of infection control outcomes (silver-hydrogel coating) or irritation/discomfort (nitrofural) in clinical trials. Recent research has now shown that biofilm formation is caused by protein deposition which will also cause inflammation and immunoreaction. Therefore, the next generation technology needs both antimicrobial functionalities along with anti-immunoreaction capabilities to produce a compound effect for infection control. Our company invented a new category of polymer additive product (HaloAddTM) that can be cost-effectively blended into existing silicon rubber resins to produce silicone urinary catheters that can provide multiple functions such as antimicrobial, anti-protein adhesion and anti-inflammation. This phase I effort is geared towards answering some basic feasibility, efficacy, and safety questions about this approach using both in vitro and in vivo testing methods. We propose three specific aims: 1) optimize polymer synthesis and blending parameters to develop HaloAdd-blended silicone rubber formulas with maximum antimicrobial and anti-fouling efficacy; 2) determine uropathogen attachment prevention, biocompatibility, and stability of HaloAdd-blended silicone tubes; 3) demonstrate in vivo that HaloAdd catheter provides measurable anti-inflammation and anti-biofilm outcomes in a mouse infection model. Success with this phase I effort will lay the groundwork for FDA clearance for human trials.

摘要：与导管相关的尿路感染（CAUTI）是最常见的类型 医疗保健相关感染，但是目前尚无有效的技术来解决 问题。导管表面上的抗微生物（抗生物膜）功能是重要的领域 这引起了很多关注。但是，由于缺乏商业应用 临床中的感染控制结局（银毛凝胶涂料）或刺激/不适（硝化壳） 试验。最近的研究现已表明，生物膜的形成是由蛋白质沉积引起的 这也会引起炎症和免疫反应。因此，下一代 技术需要两种抗菌功能以及抗免疫反应能力 为感染控制产生复合效应。我们公司发明了一个新类别 聚合物添加剂产品（HaloAddtm）可以成本效益地混合到现有硅中 橡胶树脂生产硅酮尿导管，可以提供多种功能，例如 抗菌，抗蛋白粘附和抗炎。我的努力是针对的 使用两者都回答有关这种方法的一些基本可行性，功效和安全性问题 体外和体内测试方法。我们提出了三个具体目标： 1）优化聚合物 合成和混合参数，以开发带有卤代混合硅橡胶配方 最大抗菌和抗染色功效； 2）确定肝病附着 卤代混合硅管的预防，生物相容性和稳定性； 3）演示 霍洛德导管提供可测量的抗炎和抗生物胶片结果的体内 小鼠感染模型。这一阶段的成功努力将为FDA奠定基础 人类试验的清除。