Date of Award
Master of Science (MS)
Biomedical and Chemical Engineering
As research into the potential uses of shape memory polymers (SMPs) as implantable medical devices continues to grow and expand, so does the need for an accurate and reliable sterilization mechanism. The ability of an SMP to precisely undergo a programmed shape change will define its ability to accomplish a therapeutic task. To ensure proper execution of the in vivo shape change, the sterilization process must not negatively affect the shape memory behavior of the material. To address this need, this thesis investigates the effectiveness of a benchtop nitric oxide (NOx) sterilization process and the extent to which the process affects the shape memory behavior of a well-studied tert-Butyl Acrylate (tBA) SMP.
Quantifying the effects on shape memory behavior was performed using a two-tiered analysis. A two-tiered study design was used to determine if the sterilization process induced any premature shape recovery and to identify any effects that NOx has on the overall shape memory behavior of the foams.
Determining the effectiveness of the NOx system—specially, whether the treated samples are more sterile/less contaminated than untreated—was also performed with a two-tiered analysis. In this case, the two-tiered analysis was employed to have a secondary check for contamination. To elaborate, all of the samples that were deemed not contaminated from the initial test were put through a second sterility test to check for contamination a second time.
The results of these tests indicated the NOx system is an effective sterilization mechanism and the current protocol does not negatively impact the shape memory behavior of the tBA SMP. The samples held their compressed shape throughout the entirety of the sterilization process. Additionally, there were no observable impacts on the shape memory behavior induced by NOx. Lastly, the treated samples demonstrated lower contamination than the untreated.
This thesis demonstrates the effectiveness of NOx as a laboratory scale sterilization mechanism for heat triggered shape memory polymers. The shape memory analysis indicated that the magnitude of the length changes induced by NOx is small enough that it does not make a statistically significant impact on the shape memory behavior of the foams. Additionally, there were no observable effects on the shape memory behavior induced by NOx. The results further indicated the NOx system is effective at sterilizing porous scaffolds, as none of the sterilized samples showed contamination. Testing methods proved to be effective because the initial sterility test was able to identify all of the contaminated samples and preliminary results indicated that NOx sterilization improves the sterility of the foams.
Phillippi, Ben, "Characterizing Effects of Nitric Oxide Sterilization on tert-Butyl Acrylate Shape Memory Polymers" (2017). Theses - ALL. 128.