Advanced Bactericidal Urinary Catheters Based on Electromodulated Nitric Oxide Release

基于电调制一氧化氮释放的先进杀菌导尿管

• 批准号: 8828520
• 负责人: Hao Chen
• 金额: $ 19.99万
• 依托单位: BIOCREDE, INC.
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-15 至 2016-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8828520
• 关键词: Acute suppurative arthritis due to bacteria; Advisory Committees; Alloys; Anti-Bacterial Agents; Area; Bacteremia; Bacteria; Bacterial Counts; Bioreactors; Bladder irrigation procedure; Businesses; Catheterization; Catheters; Cells; Cessation of life; Chemistry; Clinical; Collection; Complex; Cystitis; Data; Devices; Diffuse; Drug Formulations; Electroplating; Endocarditis; Endophthalmitis; Ensure; Enterobacter; Epididymitis; Epithelial Cells; Escherichia coli; Exhibits; FDA approved; Fortune; Gamma Rays; Gases; Generations; Genus staphylococcus; Healthcare; Hydrogels; In Vitro; Incidence; Infection; Infection Control; Infection prevention; Laboratories; Lead; Life; Ligands; Local Anti-Infective Agents; Longevity; Mediating; Mediator of activation protein; Medical; Meningitis; Methods; Michigan; Microbial Biofilms; Microbiology; Muscle relaxation phase; Nitric Oxide; Nitrites; Nosocomial Infections; Nutrient; Orchitis; Osteomyelitis; Oxidation-Reduction; Patients; Performance; Phase; Polyethylenes; Polytetrafluoroethylene; Prevention; Proteus mirabilis; Provider; Pseudomonas; Pseudomonas aeruginosa; Pyelonephritis; Qualifying; Quality Control; Risk; Septicemia; Silicones; Silver; Sinus; Skeletal Muscle; Smooth Muscle; Sodium Chloride; Solutions; Stainless Steel; Sterilization; Surface; Techniques; Technology; Testing; Universities; Urine; antimicrobial; antimicrobial drug; bactericide; base; catheter associated UTI; cost; density; innovation; macrophage; prevent; prostatitis; public health relevance; research and development; seal; spine bone structure; technology development; urinary

DESCRIPTION (provided by applicant): We propose a completely new, low cost and robust bactericidal urinary 100% silicone Foley catheter with a >3-6 month shelf-life, that will utilize electromodulated delivery of nitric oxide (NO) for up to 45-60 d to serve as a potent antimicrobial/antibiofilm agent. The first generation device will possess a stable inorganic nitrit salt reservoir within on lumen, in which the nitrite can be converted electrochemically (at surface of microwire) to NO via a simple Cu(II)-ligand redox mediator. The NO released quickly diffuses out of the silicone walls onto the urine collection lumen and the catheter's outer surface to prevent/disrupt biofilm formation that will eliminate catheter-associated urinary tract infections (CAUTI). The special, ISO13485 compliant, 20Fr triple-lumen 100% silicone Foley catheter has been manufactured via an OEM company, and its unique third lumen will be employed by Biocrede Inc to contain and seal off the NO releasing formulation that is electrochemically (e-chem) activated via a miniature 10 x 10 x 20 mm power controller locked at the catheter's proximal end. To continue research and development of this advanced product, we propose: (1) to study the longevity of modulated NO release from the walls of the catheters (3 h per day for up to 45-60 d) containing our proprietary nitrite formulation to understand thresholds for effectiv biofilm prevention (Proteus mirabilis, Staphylococcus saprophyticus, and Pseudomona aeruginosa or Pseudomona Enterobacter ); (2) to perform shelf-life, kink robustness, and sterilization studies to understand product reliability and performance after >3-6 months of storage; and (3) to perform sterilization studies via ETO or Gamma radiation to reach SAL 106 of assembled catheters packaged in LLDPE bags. CAUTIs contribute to 0.5-0.7 million nosocomial hospital infections annually with a cumulative incidence of 3-6% per day of catheterization (50% at 10 days, >90% at 28 days, 100% long term) leading to complications such as cystitis, pyelonephritis, gram-negative bacteremia, prostatitis, epididymitis, urosepsis, septicemia, orchitis, endocarditis, vertebral osteomyelitis, septic arthritis, endophthalmitis, and meningitis in all patients. This new electromodulated NO release technology will help lower CAUTI related costs, and reduce or potentially eliminate near 10,000 deaths/year in the US alone. Fortune Medical, an FDA approved and ISO13485 certified company, is Biocrede's catheter OEM provider; and Biocrede (100% US owned, Ann Arbor, MI) will add the proprietary components, and perform quality control, sterilization and packaging. This proprietary technology is being optioned by Biocrede Inc through the Offices of Tech Transfer at the University of Michigan (Ann Arbor, MI).

描述（由申请人提供）：我们提出了一种全新的，低成本和稳健的杀菌100％硅硅硅硅纤维导管，> 3-6个月的保质期，该导管将利用一氧化氮（NO）提供45-60 d的电位氧化氮（NO），可作为一种有效的抗氧化抗抗细胞/抗体/抗抗生素代理。第一代装置将在腔内具有稳定的无机硝酸盐储层，其中亚硝酸盐可以通过电化学转换（在表面 通过简单的Cu（II） - 配体氧化还原介体，否。 NO释放迅速从硅胶壁上扩散到尿液收集腔和导管的外表面，以防止/破坏生物膜形成，从而消除与导管相关的尿路感染（CATI）。 The special, ISO13485 compliant, 20Fr triple-lumen 100% silicone Foley catheter has been manufactured via an OEM company, and its unique third lumen will be employed by Biocrede Inc to contain and seal off the NO releasing formulation that is electrochemically (e-chem) activated via a miniature 10 x 10 x 20 mm power controller locked at the catheter's proximal end. To continue research and development of this advanced product, we propose: (1) to study the longevity of modulated NO release from the walls of the catheters (3 h per day for up to 45-60 d) containing our proprietary nitrite formulation to understand thresholds for effectiv biofilm prevention (Proteus mirabilis, Staphylococcus saprophyticus, and Pseudomona aeruginosa or伪肠杆菌）; （2）进行保质期，扭结鲁棒性和灭菌研究，以了解储存> 3-6个月后的产品可靠性和性能； （3）通过ETO或伽马辐射进行灭菌研究，以达到包装在LLDPE袋中包装的组装导管的SAL 106。 CAUTIs contribute to 0.5-0.7 million nosocomial hospital infections annually with a cumulative incidence of 3-6% per day of catheterization (50% at 10 days, >90% at 28 days, 100% long term) leading to complications such as cystitis, pyelonephritis, gram-negative bacteremia, prostatitis, epididymitis, urosepsis, septicemia, orchitis,心内膜炎，椎骨骨髓炎，化脓性关节炎，内脑炎和 所有患者的脑膜炎。这项新的电气编码的无释放技术将有助于降低与CAUTI相关的成本，并仅在美国就可以减少或可能消除近10,000人死亡。 FETUNE Medical是FDA批准和ISO13485认证公司，是Biocrede的导管OEM提供商； Biocrede（美国100％拥有，安阿伯，密歇根州）将添加专有组件，并执行质量控制，灭菌和包装。 Biocrede Inc通过密歇根大学（密歇根州安阿伯）的技术转移办公室选择了这项专有技术。