Patients across the spectrum of ages, diagnoses and locations of care often require Central Venous Catheters (CVLs) in order to receive intravenous therapy for a relatively long duration (8% of the US hospital population have a CVL). As with any indwelling device, CVLs introduce a risk of infection, referred to as Central line?associated bloodstream infections (CLABSIs). The 250,000 CLABSIs per year in the US create a significant burden on the healthcare system, with expenses over a $1 billion per year ($16,000 to $32,000/patient) (1) and mortality at 10-25% (6). Despite the enormous efforts of healthcare and public health professionals, CLABSIs remain a stubborn and deadly problem. The ultimate goal of our project is to improve outcomes for patients with peripherally inserted central catheters (PICCs), a common type of CVL, by reducing dangerous complications related to infection. Our omniphobic coating termed TLP stops the adhesion of all manner of biological components (bacteria, fungi, blood components) to the surface of medical devices by immobilizing a thin layer of highly inert and biocompatible perfluorinated liquid (3). These perfluorinated liquids have been proven to be biocompatible as blood substitutes, surgical tools, and used in liquid ventilation. In our previous work, we demonstrated that our novel tethered-liquid perfluorocarbon (TLP) coating resists the adhesion of pathogens (gram-positive and gram- negative bacteria and fungi) and blood clotting components (platelets and fibrin) to the surface of medical devices (3,7,8). Research through Phase 1 has been extremely successful, demonstrating biofilms do not form on TLP coatings over a 90 day period of venous level flow, and, additionally, TLP coatings prevent the cascade of thrombosis on its surfaces. Prevention of thrombus formation further prevents biofilm formation and improves catheter patency. We have developed a superior method for manufacturing TLP treated devices, replacing the most complex steps with simpler methods. We have also shared this technology with the FDA through a similar device and received positive feedback for a 510K submission. Medical leaders at Boston Children?s Hospital and scientists at Bard Access/BD are assisting us in the development of this technology. We are currently developing our plan for the commercialization of this technology.
FreeFlow Medical Devices is using an inert surface chemistry to prevent the formation of biofilms and thrombosis on medical devices implanted in the body. Significant in- vitro and animal testing has supported the efficacy of this coating in catheters over 90 days in biological flow. Top hospitals (Boston Children?s Hospital) and major medical device companies (Bard Access/BD) are supporting the development of this technology.
