BIOACTIVE LUMINAL INSERT TO REDUCE CATHETER INFECTIONS AND THROMBOTIC OCCLUSIONS

ABSTRACT A wide range of vascular catheters provide access to the blood stream enabling administration of therapies, nutrition, and removal of toxins and metabolites. Approximately 135 million critical vascular access procedures are performed in US hospitals annually. When not maintained consistently microbial infections and thrombotic occlusions affect catheter lumens compromising performance and posing risk to the patient’s life. These catheter complications are challenging to manage and expensive to treat. Only a few products on the market address intraluminal complications of vascular access devices. Infection prevention products such as antimicrobial end caps, drug eluting antimicrobial connectors and coated catheters are limited by the lack of long-term protection (rapid depletion of active agents), and/ or only offer localized protection of the hubs/ports. Heparin locks leak at the catheter tip and are replaced by blood making them ineffective and heparin coated catheters fail to prevent long-term thrombus formation. One product that is used to reverse thrombotic occlusion is CathFlo®. However, it is expensive (~$90/dose), requires long wait times (2-4h) to restore patency and, is used only after a lumen is occluded and not in preventative mode. The applicants have developed a unique product that combines both anti-infective and anti-thrombotic technologies to effectively reduce intraluminal infections and thrombotic occlusions in vascular catheters. If this novel technology is commercialized successfully, it will be the first product on the market with both functionalities. The goal of the proposed feasibility studies is to develop an optimal design for this early-stage concept and study its performance in appropriate preclinical models. Preliminary design optimization studies will be conducted to select a technology configuration with superior performance with respect to the dual functionalities, namely antimicrobial and anti-thrombotic. In vitro models will be employed to evaluate the antimicrobial performance and the anti-thrombotic occlusion properties of designs will be assessed in an in vitro blood flow model. Biocompatibility and mechanical testing of the proposed technology will also be conducted using relevant standards. Appropriate sample size and controls (including uncoated catheters, antimicrobial end caps, coated catheters and CathFlo®) will be employed in the proposed studies. Demonstration of feasibility in Phase-I will set the stage for further commercialization of this technology.