氟橡胶246B作为胆管替代物的可行性(英文)

Feasibility of fluoroelastomer-246B as the substitute of bile duct

背景：氟橡胶 246B 具有比聚乙烯、聚丙烯更好的组织相容性,类似于较为广泛的膨体聚四氟乙烯,而又具有比膨体聚四氟乙烯更好的硬度,自身不易发生形变。目的：通过对氟橡胶 246B 进行新鲜胆汁浸泡、常规方式消毒和大鼠体内植入实验,明确氟橡胶 246B 作为人体内植入物、人工胆管替代物的可行性。设计：对照观察。单位：吉林大学第一医院,吉林大学超分子结构与材料教育部重点实验室。材料：实验于 2006-06/2007-03 在吉林大学超分子结构与材料教育部重点实验室完成。选择清洁级雄性 Wistar 大鼠 35 只,4～5 周龄,体质量 140～160 g,由吉林大学基础医学部实验动物中心提供（实验动物机构许可证号：SCXK-（吉）2003-0001）。术前禁食 5 h,不禁水。实验用主要材料：氟橡胶 246B 为扬中市橡胶塑料厂产品,膨体聚四氟乙烯为上海索康医用材料公司产品。方法：①制作 50 mm×10 mm×0.5 mm 矩形氟橡胶 246B 薄片,放入盛有新鲜胆汁的烧杯内浸泡,并放入 37 ℃恒温箱内保存,浸泡 30 d后取出,测量拉伸强度、热分解温度、玻璃化转变温度,与浸泡前测得值进行对比,以明确氟橡胶 246B 长期处于胆汁环境内是否改变其理化性质。②制作 50 mm×10 mm×0.5 mm 矩形氟橡胶 246B 薄片,进行煮沸法、甲醛蒸气熏蒸法和甲醛溶液浸泡法消毒,然后测量拉伸强度、热分解温度、玻璃化转变温度,与消毒前测得值进行对比,以明确氟橡胶 246B 是否可以进行消毒使用。③将氟橡胶 246B、膨体聚四氟乙烯、聚丙烯、聚乙烯制成大小、厚度相等薄片分别植入大鼠腹腔内,30 d 后开腹取薄片周围组织制作病理切片,观察其在大鼠腹腔内与周围组织是否存在变态反应及炎症反应情况。主要观察指标：①氟橡胶 246B 薄片胆汁浸泡 30 d 后,测量拉伸强度、热分解温度、玻璃化转变温度,与浸泡前对比。②氟橡胶 246B 薄片经煮沸法、甲醛蒸气熏蒸法、甲醛溶液浸泡法消毒后,测量拉伸强度、热分解温度、玻璃化转变温度,与消毒前对比。③观察病理片中变态反应细胞、炎症细胞数量。结果：①氟橡胶 246B 在新鲜胆汁浸泡 30 d 后,与浸泡前相比,热分解温度、玻璃化转变温度和拉伸强度均改变微小,差异无显著性意义（P 〉 0.05）。②氟橡胶 246B 在胆汁浸泡前后、消毒前后均可较好的对抗机械性应力。③对氟橡胶 246B进行煮沸法、甲醛蒸气熏蒸法和甲醛溶液浸泡法消毒处理后,测得热分解温度、玻璃化转变温度和拉伸强度与消毒前相比也无明显改变,差异无显著性意义（P 〉 0.05）。④氟橡胶 246B 在大鼠体内植入后未出现明显变态或过敏反应,与周围组织炎症轻微,与膨体聚四氟乙烯相似,差异无显著性意义（P 〉 0.05）。结论：氟橡胶 246B 与胆汁长期接触后的主要理化性质未发生明显改变,能够对抗机械性应力,能够消毒使用,不引起变态或过敏反应。因此,氟橡胶 246B 可以作为胆管替代物材料。

BACKGROUND： Fluoroelastomer-246B has better histocompatibility than polyethylene and polypropylene, which is the same as expanded polytetrafluoroethylene （ePTFE）. Besides, fluoroelastomer-246B has better rigidity than ePTFE, so it is hard to deform. OBJECTIVE： To investigate the feasibility of fluoroelastomer-246B as a human implant in vivo and a substitute of human bile duct by the test of bile soak, routine sterilized method, and implantation into rat abdominal cavity. DESIGN： A controlled observation. SETTING： First Hospital of Jilin University ＆ Key Laboratory of Education Ministry for Supramolecular Structure and Material of Jilin University. MATERIALS： This study was performed at the Key Laboratory of Education Ministry for Supramolecular Structure and Material of Jilin University from June 2006 to March 2007. A total of 35 male Wistar rats of clean grade, aged 4-5 weeks, weighing 140-160 g, were provided by Laboratory Animal Center, School of Basic Medical Sciences, Jilin University [Permission No. SCXK （Ji） 2003-0001]. Prior to surgery, the Wistar rats were fasted for 5 hours, but they were allowed to access to water freely. The main materials used in the present study were as follows： fluoroelastomer-246B （Yangzhong Municipal Rubber ＆ Plastics Plant, China）, ePTFE（Shanghai Suo-Kang Medical Implants Co.,Ltd,, China）. METHODS： Rectangular fluoroelastomer-246B thin slices （50 mm ×10 mm×0.5 mm） made were placed in a beaker filled with fresh bile, and preserved in a 37℃ thermostat container. The tensile strength, thermal decomposition temperature and glass transition temperature of fluoroelastomer-246B were tested after 30 days, and the results were compared to those before soaking to investigate whether the physical-chemical properties of fluoroelastomer-246B slices would change after soaking in the bile environment for a long time. The rectangular fluoroelastomer-246B thin slices made as above were sterilized by boiling method, formaldehyde vapors fumigating method, and formaldehyde fluid soaking method. The indices mentioned above were measured, and the data were compared to those before sterilizing to identify whether fluoroelastomer-246B could be used after sterilizing. The same-size slice of fluoroelastomer-246B, ePTFE, polypropylene and polyethylene was separately implanted into rat abdominal cavity. The slices were taken out after 30 days, and the pathological sections of surrounding tissues were made to observe whether allergic response and/or inflammatory reactions existed. MAIN OUTCOME MEASURES： After fluoroelastomer-246B thin slices were soaked in bile for 30 days, their tensile strength, thermal decomposition temperature and glass transition temperature were tested, and the results were compared to those before soaking. After fluoroelastomer-246B thin slices were sterilized by boiling method, formaldehyde vapors fumigating method, and formaldehyde fluid soaking method, the indices mentioned above were measured, and the data were compared to those before sterilizing. The numbers of cells with allergic response and cells with inflammatory reaction were counted. RESULTS： After soaking in the fresh bile for 30 days, the tensile strength, thermal decomposition temperature and glass transition temperature of fluoroelastomer-246B changed slightly compared to before soaking （P 〉 0.05）. Fluoroelastomer-246B could well antagonize mechanical stress after bile soaking and sterilizing. Under going sterilizing by boiling method, formaldehyde vapors fumigating method and formaldehyde fluid soaking method separately, the tensile strength, thermal decomposition temperature and glass transition temperature of fluoroelastomer-246B had no marked changes （P 〉 0.05）. No noticeable allergic response was observed after fluoroelastomer-246B was implanted into rat abdominal cavity, whereas slight inflammatory reaction was detected, which was similar to ePTFE （P 〉 0.05）. CONCLUSION： The primary physical-chemical properties of fluoroelastomer-246B do not change after soaking in bile for 30 days. Fluoroelastomer-246B can well antagonize mechanical stress and be used after sterilizing without metaphysis or allergic response. Therefore, fluoroelastomer-246B can be used as a substitute of bile duct.