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Advanced Nitric Oxide Release Bactericidal Urinary Catheters

先进的一氧化氮释放杀菌导尿管

基本信息

批准号：
8591995
负责人：
Hao Chen
金额：
$ 14.91万
依托单位：
BIOCREDE, INC.
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-09-15 至 2014-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8591995
关键词：
Acute suppurative arthritis due to bacteria Advisory Committees Alloys Antimicrobial Resistance Bacteremia Bacteria Bioreactors Bladder irrigation procedure Body Temperature Buffers Caring Catheterization Catheters Cells Centers for Disease Control and Prevention (U.S.)Cessation of life Chemiluminescence assay China Cystitis Devices Drug Formulations Effectiveness Elastomers Endocarditis Endophthalmitis Enterococcus faecalis Epididymitis Epithelial Cells Escherichia coli Exhibits Film Germany Growth Healthcare Hospitals In Vitro Incidence Incubated Infection Infection Control Infection prevention Insurance Japan Lasers Lead Legal patent Length of Stay Life Light Local Anti-Infective Agents Lung Marketing Mediating Medical Device Meningitis Mercury Poisoning Methods Michigan Microbial Biofilms Muscle relaxation phase N-acetylpenicillamine Nitric Oxide Nitric Oxide Donors Nosocomial Infections Orchitis Oryctolagus cuniculus Osteomyelitis Patients Performance Pharmaceutical Preparations Phase Polyethylenes Polymers Polyurethanes Prevention Price Process Property Proteus mirabilis Protocols documentation Pyelonephritis Reporting Risk S-Nitroso-N-Acetylpenicillamine Safety Sales Savings Septicemia Silicones Silver Sinus Skeletal Muscle Smooth Muscle Solvents Source Staphylococcus epidermidis Sterilization Surface Swelling Techniques Technology Temperature Toxic effect Translations Universities Urinary tract Urine antimicrobial antimicrobial drug bactericide base biomaterial compatibility catheter associated UTI copolymer copper poisoning cost cytotoxicity density dimer experience irritation light emission macrophage novel phase 2 study polydimethylsiloxane prevent prostatitis public health relevance research and development spine bone structure technology development urinary

项目摘要

DESCRIPTION (provided by applicant): We propose a novel and competitive urinary tract silicone Foley catheter made from a proprietary polymeric formulation to effectively reduce catheter-associated urinary tract infections (CAUTI) via nitric oxide (NO) release. Preliminary studies show that the device will be able to: (1) continuously deliver NO at rates enough to maintain bactericidal properties for >2 weeks at 37¿C, (2) deliver controlled increased NO levels with enhanced bactericidal properties using light if needed, and (3) allow to be dry-stored for more than 2 months of shelf life even at 37¿C. 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 n all patients. The proposed device can be processed and assembled in the US at almost half the cost of current silver coated Foley catheters', and could potentially prevent ten thousand deaths per year due to CAUTIs. In terms of reimbursement, hospitals will see average care reduction costs of $700 per case by eliminating infection, and insurance companies will see significant decrease in length of hospital stay savings as CAUTI rates are reduced. To continue research and development of our product, we propose: (1) to study the NO release from the walls of the catheters containing our proprietary formulation to understand thresholds for effective biofilm prevention (Proteus mirabilis, Enterococcus faecalis, and Staphylococcus epidermidis); (2) to understand the light emission requirements at 590nm to photochemically prevent biofilm formation; and (3) to perform shelf-life, and sterilization studies to understand product reliabiliy and performance after 6 months of storage. Sterilization studies have been chosen over biocompatibility studies (to be done in Phase II) since the proprietary main NO donor molecule, once decomposed, is an approved drug. This proprietary technology has been optioned by Biocrede Inc. (Ann Arbor, MI) through the Offices of Tech Transfer at the University of Michigan (Ann Arbor, MI). BWTEK (Newark, DE) with offices in Japan, Germany, and China and a strong global sales team and vast experience with medical devices and laser startups, will acquire/incubate Biocrede for accelerated translation Phase II studies after positive Phase I feasibility results.

描述（由申请人提供）：我们提出了一种由专有聚合物配方制成的新型竞争性尿路硅胶Foley导管，可通过释放一氧化氮（NO）有效减少导管相关尿路感染（CANTI）。初步研究表明，该装置将能够：（1）以足以在37 ℃下保持杀菌性能>2周的速率连续输送NO，（2）如果需要，使用光输送受控增加的NO水平，同时增强杀菌性能，以及（3）即使在37 ℃下也可以干燥储存超过2个月的保质期。尿路感染每年导致50 - 70万例医院感染，每天导管插入的累积发生率为3- 6（10天时50%，28天时>90%，长期100%）导致并发症，如膀胱炎、肾盂肾炎、革兰氏阴性菌血症、前列腺炎、附睾炎、尿脓毒症、败血症、睾丸炎、心内膜炎、脊椎骨髓炎、脓毒性关节炎，眼内炎和脑膜炎。所提出的装置可以在美国加工和组装，成本几乎是目前银涂层Foley导管的一半，并且每年可以潜在地防止1万例因尿道炎而死亡。在报销方面，通过消除感染，医院将看到平均每例护理费用减少700美元，保险公司将看到随着CITTI费率的降低，住院时间的节省将显著减少。为了继续研究和开发我们的产品，我们建议：（1）研究含有我们专有配方的导管壁的NO释放，以了解有效生物膜预防的阈值（奇异变形杆菌、粪肠球菌和表皮葡萄球菌）;（2）了解590 nm处的光发射要求以光化学方式防止生物膜形成;和（3）进行有效期和灭菌研究，以了解产品储存6个月后的可靠性和性能。选择灭菌研究而不是生物相容性研究（将在第II阶段完成），因为专有的主要NO供体分子一旦分解，就是一种批准的药物。这项专有技术已被Biocrede Inc. (Ann Arbor，MI）通过密歇根大学（安阿伯，MI）的技术转移办公室。BWTEK（纽瓦克，DE）在日本，德国和中国设有办事处，拥有强大的全球销售团队和丰富的医疗器械和激光初创公司经验，将收购/孵化Biocrede，在获得积极的第一阶段可行性结果后进行加速翻译第二阶段研究。