Nathan Adam L, Fletcher Grace K, Monroe Mary Beth B, Hwang Wonjun, Herting Scott M, Hasan Sayyeda M, Keller Brandis K, Maitland Duncan J
Biomedical Engineering, Texas A&M University, College Station, TX 77843.
Shape Memory Medical, Inc., Santa Clara, CA 95054.
J Med Device. 2017 Mar;11(1):0110091-110099. doi: 10.1115/1.4035547. Epub 2017 Jan 16.
Highly porous, open-celled shape memory polymer (SMP) foams are being developed for a number of vascular occlusion devices. Applications include abdominal aortic and neurovascular aneurysm or peripheral vascular occlusion. A major concern with implanting these high surface area materials in the vasculature is the potential to generate unacceptable particulate burden, in terms of number, size, and composition. This study demonstrates that particulate numbers and sizes in SMP foams are in compliance with limits stated by the most relevant standard and guidance documents. Particulates were quantified in SMP foams as made, postreticulation, and after incorporating nanoparticles intended to increase material toughness and improve radiopacity. When concentrated particulate treatments were administered to fibroblasts, they exhibited high cell viability (100%). These results demonstrate that the SMP foams do not induce an unacceptable level of risk to potential vascular occlusion devices due to particulate generation.
高度多孔、开孔形状记忆聚合物（SMP）泡沫正在被开发用于多种血管闭塞装置。应用包括腹主动脉和神经血管动脉瘤或外周血管闭塞。将这些高表面积材料植入脉管系统的一个主要问题是，就数量、大小和成分而言，有可能产生不可接受的微粒负荷。本研究表明，SMP泡沫中的微粒数量和大小符合最相关标准和指导文件规定的限值。对制成的、网状化后的SMP泡沫以及掺入旨在提高材料韧性和改善射线不透性的纳米颗粒后的SMP泡沫中的微粒进行了定量。当对成纤维细胞进行浓缩微粒处理时，它们表现出高细胞活力（100%）。这些结果表明，SMP泡沫不会因微粒产生而对潜在的血管闭塞装置造成不可接受的风险水平。
