Advanced Nitric Oxide Release Bactericidal Urinary Catheters

描述（由申请人提供）：我们提出一种新型且具有竞争力的尿路硅胶Foley导尿管，由专有聚合物配方制成，通过一氧化氮（NO）释放有效减少导尿管相关性尿路感染（CAUTI）。初步研究表明，该装置将能够：(1)在37℃下以足够的速度连续释放一氧化氮，以保持50周的杀菌性能；(2)在需要时使用光释放可控的增加的一氧化氮水平，并增强杀菌性能；(3)即使在37℃下也可以干燥储存超过2个月的保质期。CAUTIs每年导致50 - 70万例院内感染，每日导尿累计发生率为3-6%(10天为50%，28天为90%，长期为100%)，导致所有患者出现膀胱炎、肾盂肾炎、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、椎体骨髓炎、脓毒性关节炎、眼内炎和脑膜炎等并发症。该装置可以在美国加工和组装，成本几乎是目前镀银Foley导管的一半，并且每年有可能防止因CAUTIs导致的1万人死亡。在报销方面，通过消除感染，医院将看到平均每个病例减少700美元的护理费用，保险公司将看到住院时间节省的显著减少，因为CAUTI费率降低了。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上的NO释放，以了解有效生物膜预防的阈值（变形杆菌、粪肠球菌和表皮葡萄球菌）；(2)了解590nm光发射要求，以光化学方式防止生物膜的形成；(3)进行保质期、灭菌研究，了解产品储存6个月后的可靠性和性能。灭菌研究已被选择在生物相容性研究（将在第二阶段进行），因为专有的主要NO供体分子，一旦分解，是一种批准的药物。Biocrede公司（Ann Arbor， MI）通过密歇根大学（Ann Arbor， MI）的技术转移办公室选择了这项专利技术。BWTEK （Newark， 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设备和激光初创公司经验，在获得积极的I期可行性结果后，BWTEK将收购/孵化Biocrede，以加速二期转化研究。

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.