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).
Catheter-associated urinary tract infections (CAUTI) contribute to 0.5-0.7 million nosocomial hospital infections 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 and approximately ten thousand deaths annually. Current CAUTI prevention techniques, including use of routine irrigation of the bladder with antimicrobials and silver coate Foley catheters, have no significant preventative effects, as stated by the Healthcare Infection Control Practices Advisory Committee. We propose a completely new, low cost and robust bactericidal urinary 100% silicone Foley catheter that utilizes advanced electrochemically modulated release of nitric oxide (NO) from an inorganic nitrite reservoir within the catheter to dramatically reduce CAUTIs for up to [45-60 d] of catheter use.
