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research-article

Effects of Sterilization on Shape Memory Polyurethane Embolic Foam Devices

[+] Author and Article Information
Rachael L Muschalek

Biomedical Engineering, Texas A&M University, College Station, TX, 77843
rmuschalek2015@gmail.com

Landon Nash

Biomedical Engineering, Texas A&M University, College Station, TX, 77843Shape Memory Medical, Inc., Santa Clara, CA, 95054
landonnash@tamu.edu

Ryan Jones

Biomedical Engineering, Texas A&M University, College Station, TX, 77843
jonesrya@tamu.edu

Sayyeda M Hasan

Biomedical Engineering, Texas A&M University, College Station, TX, 77843Shape Memory Medical, Inc., Santa Clara, CA, 95054
marziyahasan@gmail.com

Brandis K Keller

Biomedical Engineering, Texas A&M University, College Station, TX, 77843
bkeller@tamu.edu

Mary Beth B Monroe

Biomedical Engineering, Texas A&M University, College Station, TX, 77843
mbbmonroe@tamu.edu

Duncan Maitland

Biomedical Engineering, Texas A&M University, College Station, TX, 77843Shape Memory Medical, Inc., Santa Clara, CA, 95054
djmaitland@tamu.edu

1Corresponding author.

ASME doi:10.1115/1.4037052 History: Received August 03, 2016; Revised May 09, 2017

Abstract

Shape memory polymer (SMP) foams have been developed for various embolic 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 SMP-based 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 (non-traditional 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.

Copyright (c) 2017 by ASME
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