硅胶胰肠吻合器的研制及其在动物试验中的应用

发布时间：2018-06-08 19:52

  本文选题：胰肠吻合器 + 甲基乙烯基硅橡胶　； 参考：《西安科技大学》2015年硕士论文

【摘要】：胰十二指肠切除术是胰腺、胆管与十二指肠区域各类肿瘤唯一根治的手段,但该切除术手术复杂且并发症多,胰瘘就是其中最危险的并发症之一,为了提高手术成功率、减少术后并发症、降低患者的死亡率,对胰肠吻合术的研究便成了学者们的研究热点,其中使用胰肠吻合器实施吻合术就是其中一个重要的方面。本论文研发设计了一种胰肠吻合器,以甲基乙烯基硅橡胶为基体材料,添加硫化剂过氧化二苯甲酰(BPO),加成硫化剂聚烃基氢硅氧烷,补强填料气相法白炭黑,结构控制剂二苯基硅二醇,催化剂季铵碱,埋入钛钉,一次硫化成型制备出胰肠吻合器。通过傅里叶变换红外光谱(FTIR)对胰肠吻合器的化学结构进行表征,通过热失重分析(TGA)和热空气老化试验对其热性能进行分析,通过力学性能实验对其拉伸强度和断裂伸长率进行测试,通过耐介质性测试观察其接触到水、酒精及双氧水的性能变化,通过环氧乙烷灭菌测试测定其灭菌前后力学性能的变化。进行了家犬活体实验,通过切断空肠、破坏粘膜,胰腺套入空肠,吻合器包裹套端,固定吻合器,完成了活体手术。通过腹部X光片对胰肠吻合器的水平方向及垂直方向的钛钉对位进行观察,通过病理学分析胰腺与肠壁之间纤维组织增生情况,通过解剖学分析试验犬腹部各器官的变化。结果表明:FTIR证实了聚烃基氢硅氧烷上的Si-H与硅橡胶中的-C=C之间硅氢加成反应的进行。二苯基硅二醇可有效消除气相法白炭黑的结构化现象,使胰肠吻合器表面平整、均一。吻合器长16cm,宽1cm。厚0.2cm,且长度可根据病灶部位进行修剪。断裂伸长率和拉伸强度达282.6%和2.17MPa,质量损失5%时所对应的温度为429.9℃,经历280℃×6h的热空气,其断裂伸长率和拉伸强度仅下降了25.6%和2.3%。经过蒸馏水、75%酒精、3%双氧水,NaOH(pH=9)和HCl(pH=0.8)浸泡的吻合器表观无变化,质量损失仅为5.63%、1.52%、4.08%、5.20%和2.26%。经环氧乙烷灭菌后的吻合器,其力学性能和外观无变化。医学分析表明:吻合器钛钉均匀垂直地刺入进胰腺组织内,无脱落、降解、移位;术后第10天胰腺与肠壁之间已有大量纤维组织增生,毛细血管形成,十二指肠和胰腺已能进行正常的血液循环,且试验犬腹部各器官无明显肿胀,无胰瘘、脓肿、出血,腹腔内无明显腹水形成。通过本论文的研究,我们发现硅橡胶因其生理无毒性可以用来制作吻合器,并能满足各指标要求;与传统的胰肠吻合术相比,使用吻合器的吻合口质量好,手术时间短,手术难度低。可说明使用胰肠吻合器改进胰十二指肠切除术是一个切实可行的办法。本论文的研究既加强了材料学科与生物医学学科之间的交流沟通,也为今后新材料的研发方向提供了一个新的参考。
[Abstract]:Pancreaticoduodenectomy is the only way to cure all kinds of tumors of pancreas, bile duct and duodenum, but it is complicated and has many complications. Pancreatic fistula is one of the most dangerous complications. To reduce postoperative complications and reduce the mortality of patients, the research on pancreaticojejunostomy has become a hot research topic, among which the use of pancreaticointestinal stapler is one of the important aspects of pancreaticojejunostomy. In this paper, a pancreaticojejunal stapler was developed and designed, in which methyl vinyl silicone rubber was used as the matrix material, the vulcanizing agent was added with dibenzoyl peroxide (BPO), the addition agent was polyalkylhydrosiloxane, and the filler was reinforced with silica by gas phase method. The pancreaticointestinal stapler was prepared by the structure control agent diphenylsilyl diol, catalyst quaternary ammonium base, embedded titanium nail, and first vulcanization. The chemical structure of pancreaticointestinal stapler was characterized by Fourier transform infrared spectroscopy (FTIR), and its thermal properties were analyzed by thermogravimetric analysis (TGA) and thermal air aging test. The tensile strength and elongation at break were tested by mechanical property test, and the changes of properties of water, alcohol and hydrogen peroxide were observed by medium resistance test. The mechanical properties before and after sterilization were measured by ethylene oxide sterilization test. By cutting the jejunum, destroying the mucous membrane, inserting the pancreas into the jejunum, wrapping the end of the stapler and fixing the stapler, the in vivo operation was carried out. The horizontal and vertical orientation of pancreaticointestinal stapling was observed by abdominal X-ray film. The proliferation of fibrous tissue between pancreas and intestinal wall was analyzed by pathology. The changes of abdominal organs in dogs were analyzed by anatomy. The results show that the Si-H reaction between Si-H on polyalkylhydrosiloxane and Con C in silicone rubber is confirmed by WFTIR. Diphenyl silyl can effectively eliminate the structured phenomenon of gas phase silica and make the surface of pancreaticointestinal stapler smooth and uniform. The stapler is 16 cm long and 1 cm wide. The thickness is 0.2 cm, and the length can be pruned according to the location of the lesion. The elongation at break and tensile strength reached 282.6% and 2.17 MPA, and the corresponding temperature was 429.9 鈩，

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