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Carrie A. Strief - One of the best experts on this subject based on the ideXlab platform.
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In vitro methodology for Medical Device Material thrombogenicity assessments: A use condition and bioanalytical proof‐of‐concept approach
Journal of Biomedical Materials Research Part B: Applied Biomaterials, 2020Co-Authors: Michael F. Wolf, Gaurav Girdhar, Arielle A. Anderson, Samantha Ubl, Sinduja Thinamany, Hannah N. Jeffers, Courtney E. Derusha, Jenny Rodriguez‐fernandez, Sebastian Hoffmann, Carrie A. StriefAbstract:Device manufacturers and regulatory agencies currently utilize expensive and often inconclusive in vivo vascular implant models to assess implant Material thrombogenicity. We report an in vitro thrombogenicity assessment methodology where test Materials (polyethylene, Elasthane™ 80A polyurethane, Pebax®), alongside positive (borosilicate glass) and negative (no Material) controls, were exposed to fresh human blood, with attention to common blood-contact use conditions and the variables: Material (M), Material surface modification (SM) with heparin, model (Mo), time (T), blood donor (D), exposure ratio (ER; cm2 Material/ml blood), heparin anticoagulation (H), and blood draw/fill technique (DT). Two models were used: (1) a gentle-agitation test tube model and (2) a pulsatile flow closed-loop model. Thrombogenicity measurements included thrombin generation (thrombin-antithrombin complex [TAT] and human prothrombin fragment F1.2), platelet activation (β-thromboglobulin), and platelet counts. We report that: (a) thrombogenicity was strongly dependent (p .05) on Mo, SM, and D (b) differences between positive control, test, and negative control Materials became less pronounced as H increased from 0.6 to 2.0 U/ml, and (c) in vitro-to-in vivo case comparisons showed consistency in thrombogenicity rankings on Materials classified to be of low, moderate, and high concern. In vitro methods using fresh human blood are therefore scientifically sound and cost effective compared to in vivo methods for screening intravascular Materials and Devices for thrombogenicity.
Bertrand Décaudin - One of the best experts on this subject based on the ideXlab platform.
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To what extent do the storage conditions of polyether‐based polyurethane have an impact on diazepam delivery?
Journal of Applied Polymer Science, 2020Co-Authors: Aurélie Maiguy‐foinard, Morgane Masse, Stéphanie Degoutin, Stéphanie Genay, Feng Chai, Christine Barthélémy, Pascal Odou, Nicolas Blanchemain, Bertrand DécaudinAbstract:Interactions between Medical Device Material and the drug itself have been evoked for polyurethane and may lead to underdosing. Polyurethane, sterilization mode, and the crosslinking level of the polymer have an influence on sorption. The aim here is to evaluate the impact of polyurethane conservation time and conditions as well as sterilization mode. Two polyurethane extension tubes were tested, one sterilized by ethylene oxide and the second by gamma radiation. Forced degradation experiments were performed. After 3 and 6 months of incubation, thermal properties, diazepam delivery and cytotoxicity of leachates were assessed. Diazepam delivery differs significantly according to the version of polyurethane. Sterilization however has no impact on diazepam delivery. No cytotoxicity was observed whatever the infusion tube and the aging conditions. In conclusion, sterilization procedures do not induce polyurethane degradation, but high temperature/relative humidity/time storage conditions lead to a slight degradation in polyurethane.
Michael F. Wolf - One of the best experts on this subject based on the ideXlab platform.
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In vitro methodology for Medical Device Material thrombogenicity assessments: A use condition and bioanalytical proof‐of‐concept approach
Journal of Biomedical Materials Research Part B: Applied Biomaterials, 2020Co-Authors: Michael F. Wolf, Gaurav Girdhar, Arielle A. Anderson, Samantha Ubl, Sinduja Thinamany, Hannah N. Jeffers, Courtney E. Derusha, Jenny Rodriguez‐fernandez, Sebastian Hoffmann, Carrie A. StriefAbstract:Device manufacturers and regulatory agencies currently utilize expensive and often inconclusive in vivo vascular implant models to assess implant Material thrombogenicity. We report an in vitro thrombogenicity assessment methodology where test Materials (polyethylene, Elasthane™ 80A polyurethane, Pebax®), alongside positive (borosilicate glass) and negative (no Material) controls, were exposed to fresh human blood, with attention to common blood-contact use conditions and the variables: Material (M), Material surface modification (SM) with heparin, model (Mo), time (T), blood donor (D), exposure ratio (ER; cm2 Material/ml blood), heparin anticoagulation (H), and blood draw/fill technique (DT). Two models were used: (1) a gentle-agitation test tube model and (2) a pulsatile flow closed-loop model. Thrombogenicity measurements included thrombin generation (thrombin-antithrombin complex [TAT] and human prothrombin fragment F1.2), platelet activation (β-thromboglobulin), and platelet counts. We report that: (a) thrombogenicity was strongly dependent (p .05) on Mo, SM, and D (b) differences between positive control, test, and negative control Materials became less pronounced as H increased from 0.6 to 2.0 U/ml, and (c) in vitro-to-in vivo case comparisons showed consistency in thrombogenicity rankings on Materials classified to be of low, moderate, and high concern. In vitro methods using fresh human blood are therefore scientifically sound and cost effective compared to in vivo methods for screening intravascular Materials and Devices for thrombogenicity.
Aurélie Maiguy‐foinard - One of the best experts on this subject based on the ideXlab platform.
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To what extent do the storage conditions of polyether‐based polyurethane have an impact on diazepam delivery?
Journal of Applied Polymer Science, 2020Co-Authors: Aurélie Maiguy‐foinard, Morgane Masse, Stéphanie Degoutin, Stéphanie Genay, Feng Chai, Christine Barthélémy, Pascal Odou, Nicolas Blanchemain, Bertrand DécaudinAbstract:Interactions between Medical Device Material and the drug itself have been evoked for polyurethane and may lead to underdosing. Polyurethane, sterilization mode, and the crosslinking level of the polymer have an influence on sorption. The aim here is to evaluate the impact of polyurethane conservation time and conditions as well as sterilization mode. Two polyurethane extension tubes were tested, one sterilized by ethylene oxide and the second by gamma radiation. Forced degradation experiments were performed. After 3 and 6 months of incubation, thermal properties, diazepam delivery and cytotoxicity of leachates were assessed. Diazepam delivery differs significantly according to the version of polyurethane. Sterilization however has no impact on diazepam delivery. No cytotoxicity was observed whatever the infusion tube and the aging conditions. In conclusion, sterilization procedures do not induce polyurethane degradation, but high temperature/relative humidity/time storage conditions lead to a slight degradation in polyurethane.
Yuyu Sun - One of the best experts on this subject based on the ideXlab platform.
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BioMaterials Immobilized with Chitosan for Rechargeable Antimicrobial Drug Delivery
Journal of biomedical materials research. Part A, 2012Co-Authors: Jie Luo, Ying Deng, Yuyu SunAbstract:Microbial contamination on Medical Device Material surfaces causes serious problems including Device-related infections. Here we report a new strategy to produce rechargeable antimicrobial bioMaterial surfaces to address the issue. Methacrylic acid (MAA) was grafted onto the surfaces of polyurethane (PU), a widely used bioMaterial with excellent biological and mechanical properties. Chitosan was covalently bonded onto the MAA-grafted surfaces. The new chitosan-containing PU strongly bound and then slowed release anionic antibiotics (e.g., rifampin) for weeks to months to kill microbes. The released drug could be recharged with the same or a different class of drugs to further extend antimicrobial duration. Also, the new surfaces demonstrated good biocompatibility against mammal cells, pointing to great potentials for a wide range of bioMedical applications. © 2012 Wiley Periodicals, Inc. J Biomed Mater Res Part A, 2013.