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Novel Coatings/Surfaces on Indwelling Medical Devices to Prevent Biofilms

Description:

 

Novel Coatings/Surfaces on Indwelling Medical Devices to Prevent Biofilms

Phase I SBIR proposals will be accepted.

Fast-Track proposals will not be accepted.

Phase I clinical trials will not be accepted.

Number of anticipated awards: 2

Budget (total costs): Phase I: up to $150,000 for up to 6 months

PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED.

Background

Microorganisms may colonize indwelling medical devices such as urinary catheters or intravascular catheters to form a biofilm. Biofilms are sessile microbial communities composed of microbial cells and an extracellular matrix termed the "extracellular polymeric substance" matrix or "EPS" that may contain specific polysaccharides, proteins, and extracellular DNA. Microorganisms comprising biofilms on these medical devices are diverse and may be polymicrobic, containing multiple taxa. Use of urinary or intravascular catheters may be associated with increased risk of catheter-associated urinary tract or central line-associated bloodstream infections, respectively. Biomaterials that completely inhibit microbial attachment have not been discovered. Novel, non-traditional technologies are needed that can prevent or substantially reduce biofilm formation, with particular efficacy against antibiotic- resistant, healthcare-associated pathogens.

Project Goals

The goal of this project is to develop coatings or altered surfaces that can be used on indwelling urinary or intravascular catheters to prevent or significantly reduce biofilm formation by organisms known to cause healthcare-associated infections. Examples of these technologies could include, but are not limited to, catheters that release materials to augment the host immune response, catheters containing enzymes designed to disperse attached microbial cells, catheters containing adsorbed biological agents, or catheters with altered chemical/physical properties.

Phase I Activities and Expected Deliverables

The technical merit or feasibility of the proposed technology should be determined using an in vitro model that is designed to simulate biofilm formation on the catheter surfaces. The in vitro model should use at least two clinically relevant organisms that are known to be responsible for catheter-associated urinary tract or catheter- associated bloodstream infections. Ideally, two approaches providing complementary data on microbial attachment (using multiple healthcare-associated pathogens) and biofilm formation should be used to provide a proof of concept for the proposed technology. Models containing actual catheter materials would be especially useful, but are not required. The goal of these studies is to provide a proof of concept for the technology.

Impact

Infections associated with the use of indwelling medical devices such as intravascular catheters and urinary catheters comprise a measurable component of healthcare-associated infections in U.S. healthcare facilities. A "biofilm- free" urinary

or intravascular catheter would substantially impact healthcare delivery and could reduce antimicrobial resistance, healthcare costs, and length of stay in the hospital.

Commercialization Potential

The commercialization potential of catheters with novel surface coatings is high because such approaches could be patentable, could have potentially broad applications to other types of indwelling medical devices (endotracheal tubes, artificial voice prostheses, intrauterine devices, artificial heart valves, prosthetic joints, etc.), or other, semi-critical devices (e.g., endoscopes), and because the market for these devices is substantial.

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