氟橡胶246B作为胆管替代物的可行性

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

目的: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。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。方法: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。①制作50mm×10mm×0.5mm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30d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50mm×10mm×0.5mm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,30d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。结果:①氟橡胶246B在新鲜胆汁浸泡30d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。

AIM： Fluoroelastomer-246B has better histocompatibility than polyethylene and polypropylene, which is the same as expanded pytetraflu-oroethylene （ePTFE）. Besides, fluoroelastomer-246B has better rigidity than ePTFE, so it is hard to deform. We studied the feasibility of fluoroelastomer-246B as an implant by the test of bile soak, routine sterilized method and planting into the abdominal cavity of rats. METHODS： Experiments were performed at the Key Laboratory of Education Ministry, Laboratory of Supramolecular Structure and Material of Jilin University from June 2006 to March 2007. （1）The 50 mm ×10 mm× 0.5 mm rectangular fluoroelastomer-246B slice was put into a beaker filled with fresh bile, preserved in 37 ℃ thermostat container. Its tensile strength, thermal decomposition temperature and glass transition temperature were tested after 30 days, and the results were compared with those before soaking, to investigate if the physical-chemical properties of fluoroelastomer-246B will change after soaking in the bile environment for a long time. （2）A 50 mm× 10 mm×0.5 mm rectangular fluoroelastomer-246B slice was made, and sterilized by boiling method, formaldehyde vapors fumigating method and formaldehyde fluid soaking method. Its tensile strength, thermal decomposition temperature and glass transition temperature were measured, and the data were compared with the figure before, to identify if it could be used for sterilizing. （3）The same size slice of fluoroelastomer-246B, ePTFE, polypropylene and polyethylene were implanted into the abdominal cavity of rats. The slices were taken out after 30 days, and then the pathological sections with the surrounding tissues were made to observe if allergic response and inflammatory reaction existed. RESULTS： （1）After soaking in the fresh bile for 30 days, the tensile strength, thermal decomposition temperature and glass transition temperature of fluoroelastomer-246B changed slightly （P 〉 0.05）. （2）Fluoroelastomer-246B could antagonize mechanical stress well after bile soaking and sterilizing. （3）Under going sterilization by boiling method, formaldehyde vapors fumigating method and formaldehyde fluid soaking method separately, fluoroelastomer-246B＇s tensile strength, thermal decomposition temperature and glass transition temperature had no obviously change （P 〉 0.05）. （4）In the rats, no obviously metaphysis or allergic response was observed after implanting fluoroelastomer-246B, whereas slight inflammation was detected, which was similar to ePTFE （P 〉 0.05）. CONCLUSION： The main physical-chemical properties of fluoroelastomer-246B do not change after soaking in bile for 30 days. Fluoroelastomer-246B can antagonize the mechanical stress well, and can be used by sterilizing. No metaphysis or allergic response is observed. Fluoroelastomer-246B can be considered to be a substitute of bile duct.