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.

导尿管相关性尿路感染（CAUTI）是泌尿外科最常见的一种感染类型