Tethered liquid perfluorocarbon coating for preventing urinary catheter colonization

PROJECT SUMMARY Urinary tract infections (UTIs) are one of the most common infections worldwide, effecting ~150 million people annually, and urinary catheters (UCs) are a major cause of UTIs. There are rt1 million Catheter-Associated Urinary Tract Infections (CAUTIs) each year in the US, with treatment costs exceeding $350 million/year. Untreated CAUTIs can lead to kidney and bloodstream infections, sepsis, or even death. While antibiotic treatment can successfully treat CAUTIs and reduce the risk of sepsis, inappropriate antibiotic use is common and promotes antimicrobial resistance and risk of Clostridium difficile colitis. Thus, better approaches are needed FreeFlow Medical Devices (FreeFlow) is optimizing and commercializing tethered liquid perfluorocarbon (TLP) coatings on medical devices. The goal of this SBIR project is to validate the hypothesis that TLP-coated UCs (TLP-UCs) will resist the adhesion of pathogens and subsequent biofilm formation that are responsible for CAUTI. Our long-term goal is to improve outcomes for patients requiring UCs by reducing the rate of complications caused by infection. Our omniphobic coating stops the adhesion of all biological components (bacteria, fungi, blood components, urine) to the surface of medical devices through the immobilization of a thin layer of highly inert and biocompatible perfluorinated liquid. Our optimized coating technology incorporates a thin fluoropolymer layer on various surfaces with the help of chemical vapor deposition technique. The objective of this phase I proposal is to obtain the proof of concept that our TLP-UCs will resist the adhesion of pathogens responsible for CAUTI for ≥30 days under physiological urine flow conditions. Although we previously achieved these goals against the pathogens responsible for bloodstream infections with central venous catheters (CVC), the inherent differences between CVC and UC and their physiological exposure mean that it is critical to ensure that these properties are retained in UCs. The goals of this phase I application will be achieved by investigating the following Specific Aims. Aim 1: Measure adherence of the TLP coating to urinary catheters and assess the ability to inhibit pathogen colonization. Aim 2: Determine the ability of TLP- coated UC to withstand physiological flow conditions and pathogen colonization. Aim 3: Determine the ability of TLP-coated UC to withstand colonization by diverse CAUTI pathogens from human specimens. Once proof of concept has been obtained, we will progress to Phase II for cGMP manufacturing and FDA-recommended biocompatibility testing ready for premarket approval.