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Effects of Terminal Sterilization on PEG-Based Bioresorbable Polymers Used in Biomedical Applications.

ABSTRACT: The effects of ethylene oxide (EO), vaporized hydrogen peroxide (VHP), gamma (?) radiation, and electron-beam (E-beam) on the physiochemical and morphological properties of medical device polymers are investigated. Polymers with ether, carbonate, carboxylic acid, amide and ester functionalities are selected from a family of poly(ethylene glycol) (PEG) containing tyrosine-derived polycarbonates (TyrPCs) to include slow, medium, fast, and ultrafast degrading polymers. Poly(lactic acid) (PLA) is used for comparison. Molecular weight (Mw) of all tested polymers decreases upon gamma and E-beam, and this effect becomes more pronounced at higher PEG content. Gamma sterilization increases the glass transition temperature of polymers with high PEG content. EO esterifies the carboxylic acid groups in desaminotyrosol-tyrosine (DT) and causes significant degradation. VHP causes hydroxylation of the phenyl ring, and hydrolytic degradation. This study signifies the importance of the chemical composition when selecting a sterilization method, and provides suggested conditions for each of the sterilization methods.

SUBMITTER: Bhatnagar D

PROVIDER: S-EPMC5340269 | biostudies-literature | 2016 Oct

REPOSITORIES: biostudies-literature

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Effects of Terminal Sterilization on PEG-Based Bioresorbable Polymers Used in Biomedical Applications.

Bhatnagar Divya D Dube Koustubh K Damodaran Vinod B VB Subramanian Ganesan G Aston Kenneth K Halperin Frederick F Mao Meiyu M Pricer Kurt K Murthy N Sanjeeva NS Kohn Joachim J

Macromolecular materials and engineering 20160711 10

The effects of ethylene oxide (EO), vaporized hydrogen peroxide (VHP), gamma (γ) radiation, and electron-beam (E-beam) on the physiochemical and morphological properties of medical device polymers are investigated. Polymers with ether, carbonate, carboxylic acid, amide and ester functionalities are selected from a family of poly(ethylene glycol) (PEG) containing tyrosine-derived polycarbonates (TyrPCs) to include slow, medium, fast, and ultrafast degrading polymers. Poly(lactic acid) (PLA) is us ...[more]

PMID: 28280451

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Project description:For use in medical balloons and related clinical applications, polymers are usually designed for transparency under illumination with white-light sources. However, when illuminated with ultraviolet (UV) or blue light, most of these materials autofluoresce in the visible range, which can be a concern for modalities that rely on tissue autofluorescence for diagnostic or therapeutic purposes. A search for published information on spectral properties of polymers that can be used for medical balloon manufacturing revealed a scarcity of published information on this subject. The aim of these studies was to address this gap. The autofluorescence properties of polymers used in medical balloon manufacturing were examined for their suitability for hyperspectral imaging and related applications. Excitation-emission matrices of different balloon materials were acquired within the 320- to 620-nm spectral range. In parallel, autofluorescence profiles from the 420- to 620-nm range were extracted from hyperspectral datasets of the same samples illuminated with UV light. The list of tested polymers included polyurethanes, nylon, polyethylene terephthalate (PET), polyether block amide (PEBAX), vulcanized silicone, thermoplastic elastomers with and without talc, and cyclic olefin copolymers, known by their trade name TOPAS. Each type of polymer exhibited a specific pattern of autofluorescence. Polyurethanes, PET, and thermoplastic elastomers containing talc had the highest autofluorescence values, while sheets made of nylon, PEBAX, and TOPAS exhibited negligible autofluorescence. Hyperspectral imaging was used to illustrate how the choice of specific balloon material can impact the ability of principal component analysis to reveal the ablated cardiac tissue. The data revealed significant differences between autofluorescence profiles of the polymers and pointed to the most promising balloon materials for clinical implementation of approaches that depend on tissue autofluorescence.

Dataset Information

Effects of Terminal Sterilization on PEG-Based Bioresorbable Polymers Used in Biomedical Applications.

Publications

Effects of Terminal Sterilization on PEG-Based Bioresorbable Polymers Used in Biomedical Applications.

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