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 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 (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.
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September 2017
Research-Article
Effects of Sterilization on Shape Memory Polyurethane Embolic Foam Devices
Rachael Muschalek,
Rachael Muschalek
Biomedical Engineering,
Texas A&M University,
College Station, TX 77843
e-mail: rmuschalek2015@gmail.com
Texas A&M University,
College Station, TX 77843
e-mail: rmuschalek2015@gmail.com
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Landon Nash,
Landon Nash
Biomedical Engineering,
Texas A&M University,
College Station, TX 77843;
Shape Memory Medical, Inc.,
Santa Clara, CA 95054
e-mail: nashlandon@gmail.com
Texas A&M University,
College Station, TX 77843;
Shape Memory Medical, Inc.,
Santa Clara, CA 95054
e-mail: nashlandon@gmail.com
Search for other works by this author on:
Sayyeda M. Hasan,
Sayyeda M. Hasan
Biomedical Engineering,
Texas A&M University,
College Station, TX 77843;
Shape Memory Medical, Inc.,
Santa Clara, CA 95054
e-mail: marziyahasan@gmail.com
Texas A&M University,
College Station, TX 77843;
Shape Memory Medical, Inc.,
Santa Clara, CA 95054
e-mail: marziyahasan@gmail.com
Search for other works by this author on:
Duncan J. Maitland
Duncan J. Maitland
Biomedical Engineering,
Texas A&M University,
College Station, TX 77843;
Shape Memory Medical, Inc.,
Santa Clara, CA 95054
e-mail: djmaitland@tamu.edu
Texas A&M University,
College Station, TX 77843;
Shape Memory Medical, Inc.,
Santa Clara, CA 95054
e-mail: djmaitland@tamu.edu
Search for other works by this author on:
Rachael Muschalek
Biomedical Engineering,
Texas A&M University,
College Station, TX 77843
e-mail: rmuschalek2015@gmail.com
Texas A&M University,
College Station, TX 77843
e-mail: rmuschalek2015@gmail.com
Landon Nash
Biomedical Engineering,
Texas A&M University,
College Station, TX 77843;
Shape Memory Medical, Inc.,
Santa Clara, CA 95054
e-mail: nashlandon@gmail.com
Texas A&M University,
College Station, TX 77843;
Shape Memory Medical, Inc.,
Santa Clara, CA 95054
e-mail: nashlandon@gmail.com
Ryan Jones
Sayyeda M. Hasan
Biomedical Engineering,
Texas A&M University,
College Station, TX 77843;
Shape Memory Medical, Inc.,
Santa Clara, CA 95054
e-mail: marziyahasan@gmail.com
Texas A&M University,
College Station, TX 77843;
Shape Memory Medical, Inc.,
Santa Clara, CA 95054
e-mail: marziyahasan@gmail.com
Brandis K. Keller
Mary Beth B. Monroe
Duncan J. Maitland
Biomedical Engineering,
Texas A&M University,
College Station, TX 77843;
Shape Memory Medical, Inc.,
Santa Clara, CA 95054
e-mail: djmaitland@tamu.edu
Texas A&M University,
College Station, TX 77843;
Shape Memory Medical, Inc.,
Santa Clara, CA 95054
e-mail: djmaitland@tamu.edu
Manuscript received August 3, 2016; final manuscript received May 9, 2017; published online June 28, 2017. Assoc. Editor: Michael Eggen.
J. Med. Devices. Sep 2017, 11(3): 031011 (9 pages)
Published Online: June 28, 2017
Article history
Received:
August 3, 2016
Revised:
May 9, 2017
Citation
Muschalek, R., Nash, L., Jones, R., Hasan, S. M., Keller, B. K., Monroe, M. B. B., and Maitland, D. J. (June 28, 2017). "Effects of Sterilization on Shape Memory Polyurethane Embolic Foam Devices." ASME. J. Med. Devices. September 2017; 11(3): 031011. https://doi.org/10.1115/1.4037052
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