SBIR-STTR Award

Omniphobic Coating to Prevent Central Line Catheter Infections
Award last edited on: 4/23/2018

Sponsored Program
SBIR
Awarding Agency
NIH : NIAID
Total Award Amount
$222,842
Award Phase
1
Solicitation Topic Code
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Principal Investigator
Andrew K Jones

Company Information

Freeflow Medical Devices LLC

31 Industrial Circle
Lancaster, PA 17601
   (717) 669-2566
   info@freeflowmed.com
   www.freeflowmed.com
Location: Single
Congr. District: 11
County: Lancaster

Phase I

Contract Number: ----------
Start Date: ----    Completed: ----
Phase I year
2018
Phase I Amount
$222,842
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 Statement:
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.

Project Terms:
Adhesions; Adhesives; Age; Bacteria; Biological; biomaterial compatibility; Blood; Blood coagulation; Blood flow; Blood Platelets; Blood Substitutes; Blood Vessels; Caring; Catheters; Cerebrum; Clinic; clinical practice; Clinical Trials; Contracts; Dangerousness; Data; design; Development; Devices; Diagnosis; Dialysis procedure; Effectiveness; Fibrin; fighting; Fluorocarbons; fungus; Goals; Gram-Negative Bacteria; Health Professional; Healthcare; Healthcare Systems; Hospitals; Immobilization; implantable device; improved outcome; In Vitro; in vivo; Industrialization; Infection; Intervention; Intravenous; Laboratories; Length of Stay; Liquid substance; Liquid Ventilation; Location; Measures; Medical Device; Medicine; Modeling; mortality; Nosocomial Infections; novel; nutrition; Operative Surgical Procedures; pathogen; Patient-Focused Outcomes; Patients; performance tests; Peripheral; Pharmaceutical Preparations; Phase; phase 1 study; phase 2 study; Physiologic arteriovenous anastomosis; Physiological; Population; Preparation; prevent; Procedures; Process; Public Health; Research; Resistance; Risk; Sepsis; Serum; Shunt Device; Sterility; Surface; Testing; Thinness; Thrombosis; Time; tool; Venous; ventricular assist device; Work

Phase II

Contract Number: ----------
Start Date: ----    Completed: ----
Phase II year
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Phase II Amount
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