Urinary tract infections (UTIs) are one of the most common infections worldwide, effecting ~150 million peopleannually, and urinary catheters (UCs) are a major cause of UTIs. There are >1 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 commonand 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 forCAUTI. Our long-term goal is to improve outcomes for patients requiring UCs by reducing the rate ofcomplications 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 thinlayer of highly inert and biocompatible perfluorinated liquid. Our optimized coating technology incorporates athin 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 theadhesion of pathogens responsible for CAUTI for â¥30 days under physiological urine flow conditions. Althoughwe previously achieved these goals against the pathogens responsible for bloodstream infections with centralvenous catheters (CVC), the inherent differences between CVC and UC and their physiological exposuremean that it is critical to ensure that these properties are retained in UCs. The goals of this phase I applicationwill be achieved by investigating the following Specific Aims. Aim 1: Measure adherence of the TLP coating tourinary 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 ofTLP-coated UC to withstand colonization by diverse CAUTI pathogens from human specimens. Once proof ofconcept has been obtained, we will progress to Phase II for cGMP manufacturing and FDA-recommendedbiocompatibility testing ready for premarket approval.
Public Health Relevance Statement: PROJECT NARRATIVE
Indwelling catheters are used in ~12% of long-term care patients; however, long-term use of urinary catheters
(UCs) facilitates bacterial and fungal colonization of urine and subsequent bladder colonization and urinary
tract infections (UTIs). Although these infections can be treated with antibiotics, antimicrobial resistance is
common and so better approaches are needed. We have developed a novel coating that can be applied to
UCs prevent microbial attachment and the subsequent processes (encrustation and biofilm formation) that lead
to UTIs and the resulting complications; in this phase I proposal, we will obtain proof of concept that the
coating successfully interferes with the processes leading to microbial colonization and subsequent infection in
preparation for a future phase II application and application for pre-market approval.
Project Terms:
