Design, Fabrication, and Testing of a Sheathed Embolization Device
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Endovascular embolization is an interventional procedure to seal off diseased vasculature from systemic circulation. Shape memory polymer (SMP) foams are a promising embolic material that can undergo shape change when exposed to stimuli, exhibit a positive healing response, and aid in rapid occlusion. SMP foams are porous materials that are composed of struts and membranes that pose a risk of generating particles during device fabrication or delivery. Herein, a sheathed embolization device (SED) was designed, fabricated, and tested to occlude a left atrial appendage (LAA) and to mitigate the generation of foam particles. The SED consists of a thin polyurethane membrane that fully encapsulates the SMP foam, and is able to undergo shape change from a compressed state to an expanded state. Material properties of the device were characterized with differential scanning calorimetry, scanning electron microscopy, and Fourier transform infrared spectroscopy. The SED was tested in terms of its ability to occlude a patient-derived LAA model, its deliverability, and its ability to reduce particles. Results from the studies demonstrate the SED’s ability to be delivered minimally invasively, reduce particles, and occlude mock vasculature. Upon actuation in body-temperature fluid the SED achieved a 10x diameter expansion, making it ideal for endovascular applications. These preliminary results support the potential to utilize SEDs to occlude vasculature while mitigating the risk of unintended ischemia due to device-based particles. The results also demonstrate the potential to integrate the SED with third- party devices or components to develop functional embolization devices, such as left atrial appendage closure devices.
Left Atrial Appendage
Shape Memory Polymer
Orendain, Adam M (2017). Design, Fabrication, and Testing of a Sheathed Embolization Device. Master's thesis, Texas A&M University. Available electronically from