Lee Joonbum, Choi Jung-Woo, Lee Sang-A, Jang Seokhyun, Seo Ji-Hun, Hong Kwang Dae
Department of Materials Science and Engineering, Korea University, 145 Anam-ro, Seongbuk-gu, Seoul 02841, Republic of Korea.
Department of Pathology, Korea University Ansan Hospital, 123 Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do 15355, Republic of Korea.
ACS Omega. 2024 Oct 21;9(43):43817-43825. doi: 10.1021/acsomega.4c06043. eCollection 2024 Oct 29.
Bulking agents have gained attention as new, minimally invasive treatments for fecal incontinence. Various materials and surface treatment techniques have been extensively studied to ensure good biocompatibility and long-term stability. Despite significant improvements in biocompatibility, the nonuniform particle size of existing materials has led to other challenges, such as the induction of phagocytosis or reduction of injectability during in vivo tests. This study aimed to conduct a preclinical test of the midterm stability of bulking agents with newly formulated particles with uniform size. To this end, the particles were fabricated using microfluidics, resulting in a narrow size dispersity of less than 5% as the coefficient of variation, which is essentially distinct from conventional bulking agents. The microfluidic fabrication resulted in uniformly sized particles larger than the in vivo migratory limit of 80 μm and in a reduction in maximum injection pressure. Histological staining and microscopic observations confirmed proper positioning of the filler materials in vivo and a negligible immune response for up to 6 months, indicating successful midterm stability.
填充剂作为治疗大便失禁的新型微创治疗方法已受到关注。人们对各种材料和表面处理技术进行了广泛研究，以确保良好的生物相容性和长期稳定性。尽管生物相容性有了显著改善，但现有材料的粒径不均匀导致了其他挑战，例如在体内测试中诱导吞噬作用或降低可注射性。本研究旨在对具有新配方均匀粒径颗粒的填充剂进行中期稳定性的临床前测试。为此，使用微流控技术制造颗粒，变异系数小于5%，粒径分散度窄，这与传统填充剂有本质区别。微流控制造产生的颗粒尺寸均匀，大于80μm的体内迁移极限，并降低了最大注射压力。组织学染色和显微镜观察证实了填充材料在体内的正确定位，以及长达6个月的可忽略不计的免疫反应，表明中期稳定性成功。
