title: Exudation of additives to the surface of medical devices: impact on biocompatibility in the case of polyurethane used in implantable catheters.
abstract: Surface state is one of the most important parameters determining the biocompatibility of an implantable medical device, any change on the surface once in contact with body tissues can impact the biological response (cytotoxicity, inflammation, irritation, thrombosis, etc.). In the present study, we use (Pellethane®) catheter-based polyurethane (PU), because of its many applications in the field of medical devices, to evaluate the impact of additives blooming on the biocompatibility. Four different antioxidants and two anti-ultraviolet stabilizers were included in this study. A comprehensive study was conducted to evaluate the consequences of cellular exposure to theses additives in the following three forms: in dissolved form and after surface blooming, in amorphous and in crystalized ones, and finally in the overall biocompatibility of the native PU. Surface roughness was analyzed with atomic force microscopy. Endothelial cells' viability was studied in contact with all the three physical forms. A preliminary hemocompatibility evaluation was performed through the measurement of whole blood hemolysis, as well as platelet adhesion in contact with the different PU samples. The study of the proinflammatory IL-α and TNF-α production by macrophages in contact with these films is also reported. © 2016 Wiley Periodicals, Inc. J Biomed Mater Res Part A: 104A: 2954-2967, 2016.
authors.affiliation: Université Paris-Sud, EA401 Matériaux et Santé, IFR 141, Faculté De Pharmacie, Châtenay Malabry, France.
authors.forename: Micheal
authors.initials: M
authors.lastname: Nouman
authors.affiliation: Université Paris-Sud, EA401 Matériaux et Santé, IFR 141, Faculté De Pharmacie, Châtenay Malabry, France. emile.jubeli@u-psud.fr.
authors.forename: Emile
authors.identifier: 0000-0003-2855-4091
authors.initials: E
authors.lastname: Jubeli
authors.affiliation: Université Paris-Sud, EA401 Matériaux et Santé, IFR 141, Faculté De Pharmacie, Châtenay Malabry, France.
authors.forename: Johanna
authors.initials: J
authors.lastname: Saunier
authors.affiliation: Université Paris-Sud, EA401 Matériaux et Santé, IFR 141, Faculté De Pharmacie, Châtenay Malabry, France.
authors.forename: Najet
authors.initials: N
authors.lastname: Yagoubi
mesh_terms: D000975:Antioxidants / Q000737:chemistry* / Q000633:toxicity; D001672:Biocompatible Materials / Q000737:chemistry* / Q000633:toxicity; D002408:Catheters, Indwelling / Q000009:adverse effects; D002448:Cell Adhesion / Q000187:drug effects; D049109:Cell Proliferation / Q000187:drug effects; D042783:Endothelial Cells / Q000166:cytology* / Q000187:drug effects; D061307:Human Umbilical Vein Endothelial Cells; D006801:Humans; D007249:Inflammation / Q000139:chemically induced; D018625:Microscopy, Atomic Force; D011140:Polyurethanes / Q000737:chemistry* / Q000633:toxicity; D013473:Sunscreening Agents / Q000737:chemistry / Q000633:toxicity; D013499:Surface Properties
chemical_list: D000975:Antioxidants; D001672:Biocompatible Materials; D011140:Polyurethanes; D013473:Sunscreening Agents
keywords: additives; atomic force microscopy; biocompatibility; blooming; polyurethane