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（由适用提供）：我们提出了一种由专有聚合物公式制成的新型且竞争性的尿路硅胶硅硅硅硅，以通过一氧化氮（NO）释放有效地减少与导管相关的尿路感染（CATI）。 Preliminary studies show that the device will be able to: (1) continuously deliver NO at rates enough to maintain bacteriaidal properties for >2 weeks at 37¿ C, (2) delivered controlled increased NO levels with enhanced bacteriaidal 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 incident of 3-6% per day of catheterization (50% at 10 days, >90% at 28 days, 100% long term) leading to complications such as cystitis, pyrenephritis, gram-negative bacteria, prostatitis, epididymitis, urosepsis, septicemia, orchitis, endocarditis, vertebral osteomyelitis, septic arthritis, endophthalmitis, and所有患者脑膜炎。提出的设备可以在美国处理和组装，几乎是当前涂层的Foley Catereters的成本的一半，并且可能会由于小蛋白酶而预防每年一千人死亡。在报销方面，医院通过消除感染将看到每例平均降低护理费用为700美元，并且保险公司将看到医院储蓄长度的大幅减少，因为CAUTI率降低。为了继续对产品的研究和开发，我们建议：（1）研究从包含我们专有公式的导管的墙壁上释放的，以了解有效的生物膜预防阈值（proteus mirabilis，proteus faeccus faecalis，肠球菌和葡萄球菌表皮）；（2）了解590nm时的光发射要求在光化学上防止生物膜形成；（3）进行保质期和灭菌研究，以了解6个月后的产品可靠性和性能。已经选择了生物相容性研究（在II阶段进行），因为专有的主体没有供体分子（曾经分解）是一种批准的药物。 Biocrede Inc.（MI Ann Arbor）已通过密歇根大学（密歇根州安阿伯市安阿伯）的技术转移办公室选择了这项专有技术。 BWTEK（纽瓦克，德国）在日本，德国和中国设有办事处，以及一个强大的全球销售团队以及对医疗设备和激光初创公司的丰富经验，将在积极的I阶段可行性结果之后收购/孵化Biocrede进行加速翻译II期研究。