Effects of sterilization on shape memory polyurethane embolic foam devices

Rachael Muschalek, Landon Nash, Ryan Jones, Sayyeda M. Hasan, Brandis K. Keller, Mary Beth B. Monroe, Duncan J. Maitland

Research output: Contribution to journalArticle

1 Scopus citations

Abstract

Polyurethane shape memory polymer (SMP) foams have been developed for various embolic medical devices due to their unique properties in minimally invasive biomedical applications. These polyurethane materials can be stored in a secondary shape, from which they can recover their primary shape after exposure to an external stimulus, such as heat and water exposure. Tailored actuation temperatures of SMPs provide benefits for minimally invasive biomedical applications, but incur significant challenges for SMPbased medical device sterilization. Most sterilization methods require high temperatures or high humidity to effectively reduce the bioburden of the device, but the environment must be tightly controlled after device fabrication. Here, two probable sterilization methods (nontraditional ethylene oxide (ntEtO) gas sterilization and electron beam irradiation) are investigated for SMP medical devices. Thermal characterization of the sterilized foams indicated that ntEtO gas sterilization significantly decreased the glass transition temperature. Further material characterization was undertaken on the electron beam (ebeam) sterilized samples, which indicated minimal changes to the thermomechanical integrity of the bulk foam and to the device functionality.

Original languageEnglish (US)
Article number031011
JournalJournal of Medical Devices, Transactions of the ASME
Volume11
Issue number3
DOIs
StatePublished - Sep 1 2017
Externally publishedYes

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ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Biomedical Engineering

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