可降解Mg-Zn-Ca合金腹腔镜手术止血夹的制备及其性能研究
发布时间：2019-03-30 18:19
【摘要】：钛合金止血夹是目前腹腔镜手术临床常用的止血夹,虽然对人体毒性较小,但其永久留存体内会带来离子溶出炎症、干扰影像学诊断以及造成患者心理负担等问题。可吸收高分子止血夹可在体内降解,但结构较复杂,对操作者技术要求高,且成本较高。针对以上问题,本文利用镁及其合金良好的生物安全性、力学性能、特别是体内可生物降解的特性开发了新型可降解镁合金腹腔镜手术止血夹,解决目前该类产品存在的局限性,对于提高手术质量以及患者术后身心健康具有重要的现实意义。本文采用自行研发的Mg-3Zn-0.2Ca合金,设计了可降解镁合金止血夹的加工工艺流程,制备了可降解Mg-3Zn-0.2Ca合金止血夹,并对制备过程中止血夹的显微组织演变、力学性能、体外降解行为、细胞毒性、动物体内组织相容性以及实际止血效果等方面进行了研究,为进一步优化镁合金止血夹的制备工艺以及实际应用效果打下了实验基础,本文研究工作的主要结论如下:1.铸态Mg-3Zn-0.2Ca合金热挤压后,晶粒显著细化,并形成了平行于挤压方向的形变织构。冲裁成型后,止血夹边缘部分晶粒细化;织构特征为(0001)基面平行于挤压法向平面。退火后,止血夹显微组织变得均匀,晶粒尺寸随退火温度的升高、保温时间的延长而增大;经300℃,120min退火后止血夹织构类型以(0001)基面织构为主,织构密度减弱、强度降低。2.ANSYS14.0有限元模拟结果表明,可降解Mg-3Zn-0.2Ca合金止血夹发生大塑性变形直至闭合,最大应变为0.247,分布于中间顶端,与实际情况相符。退火使镁合金挤压态板材强度降低,延伸率增加,止血夹闭合断裂倾向减小。退火工艺的优化结果为:退火温度300℃,保温时间120min。此工艺处理后,镁合金止血夹夹闭断裂现象基本消除,可使乳胶管完全闭合,能抵制乳胶内压力,且一周内夹持力无明显降低,具有良好的力学性能。3.可降解Mg-3Zn-0.2Ca合金止血夹体外浸泡48h内,pH值、失重均随浸泡时间的延长而升高,降解程度加重,腐蚀产物在表面大量堆积。止血夹对乳胶管的夹持力随降解反应的发生而下降,浸泡初期降解程度较小,夹持力降低速率较缓慢;浸泡前48小时止血夹未发生断裂,浸泡四天内近20%止血夹断裂,浸泡一周内止血夹全部断裂。4.Mg-3Zn-0.2Ca合金对小鼠成纤维细胞无毒性。镁合金止血夹大鼠体内生物相容性良好:肌肉间植入止血夹1~4周内,大鼠生命活动正常;血生化指标正常;组织反应合格。镁合金止血夹能完全夹闭大鼠左肾门血管,血管残端无出血,术后两周大鼠未发生渗血,止血夹结构完整,表面发生降解。
[Abstract]:Titanium alloy hemostatic clamp is a commonly used hemostatic clamp in laparoscopic surgery. Although it is less toxic to human body, its permanent retention in the body will bring about problems such as ionic dissolution inflammation, interference with imaging diagnosis and psychological burden of patients. The absorbable polymer hemostatic clamp can be degraded in vivo, but the structure is more complex, the technical requirements for operators are high, and the cost is high. In order to solve the above problems, a new biodegradable magnesium alloy laparoscopic hemostatic clamp was developed in this paper, which has good biological safety, mechanical properties, especially biodegradable properties in vivo. It is of great practical significance to improve the quality of operation and the patients' physical and mental health to solve the limitations of this kind of products. In this paper, a self-developed Mg-3Zn-0.2Ca alloy was used to design the processing process of the degradable magnesium alloy hemostatic clamp, and the biodegradable Mg-3Zn-0.2Ca alloy hemostatic clamp was prepared, and the microstructure evolution of the hemostat was stopped during the preparation process. The mechanical properties, in vitro degradation behavior, cytotoxicity, animal in vivo histocompatibility and actual hemostatic effect were studied, which laid an experimental foundation for further optimizing the preparation technology and practical application of magnesium alloy hemostatic clamp. The main conclusions of this study are as follows: 1. After hot extrusion, the grain of as-cast Mg-3Zn-0.2Ca alloy is refined remarkably, and the deformation texture parallel to the extrusion direction is formed. After blanking, the grain on the edge of hemostasis clamp is refined, and the texture characteristic is (0001) base plane parallel to the normal plane of extrusion. After annealing, the microstructure of the haemostatic clamp becomes uniform, and the grain size increases with the increase of annealing temperature and the prolongation of holding time. After annealing at 300 鈩，
本文编号：2450359
[Abstract]:Titanium alloy hemostatic clamp is a commonly used hemostatic clamp in laparoscopic surgery. Although it is less toxic to human body, its permanent retention in the body will bring about problems such as ionic dissolution inflammation, interference with imaging diagnosis and psychological burden of patients. The absorbable polymer hemostatic clamp can be degraded in vivo, but the structure is more complex, the technical requirements for operators are high, and the cost is high. In order to solve the above problems, a new biodegradable magnesium alloy laparoscopic hemostatic clamp was developed in this paper, which has good biological safety, mechanical properties, especially biodegradable properties in vivo. It is of great practical significance to improve the quality of operation and the patients' physical and mental health to solve the limitations of this kind of products. In this paper, a self-developed Mg-3Zn-0.2Ca alloy was used to design the processing process of the degradable magnesium alloy hemostatic clamp, and the biodegradable Mg-3Zn-0.2Ca alloy hemostatic clamp was prepared, and the microstructure evolution of the hemostat was stopped during the preparation process. The mechanical properties, in vitro degradation behavior, cytotoxicity, animal in vivo histocompatibility and actual hemostatic effect were studied, which laid an experimental foundation for further optimizing the preparation technology and practical application of magnesium alloy hemostatic clamp. The main conclusions of this study are as follows: 1. After hot extrusion, the grain of as-cast Mg-3Zn-0.2Ca alloy is refined remarkably, and the deformation texture parallel to the extrusion direction is formed. After blanking, the grain on the edge of hemostasis clamp is refined, and the texture characteristic is (0001) base plane parallel to the normal plane of extrusion. After annealing, the microstructure of the haemostatic clamp becomes uniform, and the grain size increases with the increase of annealing temperature and the prolongation of holding time. After annealing at 300 鈩，
本文编号：2450359
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