Central venous catheters (CVLs) provide lifesaving medications, nutrition and laboratory testing for millions of patients a year. As with any medical device, they can become infected (250,000 infections/year in US), increasing patients' mortality and length of hospital stay. The 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 central line-associated bloodstream infections (CLABSI; 10-35 % mortality rate). We believe that stopping adhesion to the surface of the catheter will reduce complications related to infection patients with catheters. Our omniphobic coating stops adhesion of all manner of pathogens (bacteria and fungi) to the surface of medical devices by immobilizing a thin layer of highly inert and biocompatible perfluorinated liquid. In our previous work, we demonstrated that our novel tethered-liquid perfluorocarbon (TLP) coating resists pathogen adhesion in vitro and resists the adhesion of blood clotting components to the surface of medical devices, ultimately resulting in significantly less thrombosis in a challenging in vivo arteriovenous shunt model. In Phase I, we propose the development of a first-in-class TLP-coated PICC catheter that significantly reduces or eliminates catheter-associated infection in patients, potentially resulting shorter hospital stays and less mortality related to hospital-acquired infections. Milestones for Phase I include: 1) showing TLP-coated catheters resist biofouling of many CLABSI-relevant pathogens; 2) demonstrating that the TLP-coated catheters maintain biofouling resistance under extended blood serum flow. If Phase I is successful, in Phase II the TLP-coated catheter will be further evaluated for in vivo biocompatibility in preparation for FDA approval and potentially clinical practice. If successful in this challenging application, the TLP coating could help patients in many other vascular applications and more broadly in medical devices.

Public Health Relevance

Central venous catheters provide lifesaving therapy to millions of patients a year. Despite dramatic interventions in terms of sterile procedure, these catheters continue to become infected, resulting in high mortality rates. The proposed research is to develop a non-biofouling, omniphobic coated catheter that will significantly reduce infection rates in patients' who need catheters.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43AI136573-01
Application #
9466069
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Ernst, Nancy L
Project Start
2018-01-15
Project End
2019-12-31
Budget Start
2018-01-15
Budget End
2019-12-31
Support Year
1
Fiscal Year
2018
Total Cost
Indirect Cost
Name
Freeflow Medical Devices, LLC
Department
Type
DUNS #
080388725
City
Lancaster
State
PA
Country
United States
Zip Code
17601