Advanced Nitric Oxide Release Bactericidal Urinary Catheters

描述(申请人提供)：我们提出了一种新颖且具有竞争力的尿路硅胶Foley导尿管，由专利聚合物配方制成，可通过一氧化氮(NO)释放有效地减少导管相关性尿路感染(CAUTI)。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)输送受控增加的NO水平，并在需要时使用光线增强杀菌性能，以及(3)即使在37℃下也允许干燥储存超过2个月的保质期。CAUTIs每年导致50万-70万医院感染，每天导尿管的累积发生率为3-6%(10天时为50%；28天后90%，长期100%)，导致所有患者的并发症，如膀胱炎、肾炎、革兰氏阴性菌血症、前列腺炎、附睾炎、尿毒症、败血症、炎、心内膜炎、椎体骨髓炎、败血症、眼内炎和脑膜炎。建议的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，并有可能每年防止1万人死于CAUTIs。在报销方面，通过消除感染，医院将看到每个病例的平均护理成本减少700美元，随着CAUTI费率的降低，保险公司将看到住院时间节省的显著减少。为了继续研发我们的产品，我们建议：(1)研究含有我们的专利配方的导管管壁释放NO的情况，以了解有效防止生物被膜(变形杆菌、粪肠球菌和表皮葡萄球菌)的阈值；(2)了解以光化学方法防止生物被膜形成的590 nm光发射要求；以及(3)进行保质期、灭菌研究，以了解产品储存6个月后的可靠性和性能。已经选择了灭菌研究而不是生物兼容性研究(将在第二阶段进行)，因为专有的主要NO供体分子一旦分解，就是批准的药物。这项专利技术已由Biocrede Inc.(密歇根州安娜堡)通过密歇根大学(密歇根大学安娜堡)技术转移办公室选择。BWTEK(德国纽瓦克)在日本、德国和中国设有办事处，拥有强大的全球销售团队以及在医疗设备和激光初创企业方面的丰富经验，在第一阶段可行性结果积极后，将收购/孵化Biocrede进行加速翻译第二阶段研究。

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.