MICHIGAN CRITICAL CARE CONSULTANTS, INC. — Department of Health and Human Services SBIR Phase II: NHLBI

Description

DESCRIPTION provided by applicant This proposal involves the incorporation of a proprietary nitric oxide NO releasing polymer material NORL into a venous catheter to reduce infection and clotting Low levels of NO released by the normal endothelium inhibit platelet adhesion and activation thus preventing thrombus formation Further it has been shown that NO at low doses exhibits significant bactericidal activity Hence the preparation of catheters that secrete NO will solve two longstanding problems in the care of critically ill patients In Phase of this SBIR we developed a unique NO secreting polymer material that can release NO above physiological levels for up to days with minimal leaching of byproducts tested the materials for cytotoxicity and hemolysis and conducted testing in a sheep model to evaluate thrombogenicity and bacterial adherence We addressed handling and packaging requirements to maintain efficacy of the materials Based on the cost of materials and the specialized handling requirements we identified a product that would benefit from the prolonged protection offered by the material and that has a high enough sale price to tolerate the increased handling expenses This Phase II application is targeted at building out the manufacturing process found to be most effective for incorporating NORL in the catheter performing extensive preclinical assessments and evaluating the coating in vivo for anti microbial and anti platelet properties The initial target product for NORL will be a dual lumen catheter DLC suitable for adult extracorporeal membrane oxygenation ECMO Specifically we will construct a device for automated and controlled fabrication of the NORL catheter and conduct design verification of the NORL loaded catheter We will also work with our collaborators at the University of Michigan to perform extensive in vivo evaluations of the new NO release catheter At the conclusion of Phase II we will be prepared to transfer the developed process and equipment to a contract manufacturer This approach is a significant advance in improving the biocompatibility and anti microbial features of intravascular catheters since it utilizes chemistry that exactly mimics endogenous NO release function in our bodies including from endothelial cells to inhibit platelet adhesion activation and by various immune cells e g macrophages neutrophils etc to kill bacteria By decreasing both clotting and infection this technology will simultaneously increase catheter longevity and decrease patient morbidity and costs PUBLIC HEALTH RELEVANCE Clotting and infection is a major problem in intravascular IV catheters Normal blood vessels secrete a chemical called nitric oxide which prevents these problems This research will develop an ECMO Dual Lumen Catheter that secretes nitric oxide decreasing the risk of clotting and infection