新型升主动脉瘤腔内移植物系统的研制与体外实验研究
发布时间：2018-09-05 15:40
【摘要】：研究背景自1994年Dake首次报道应用腔内移植物(endovascular stent-graft)治疗胸降主动脉动脉瘤以来,胸主动脉腔内修复术(Thoracic endovascular aortic repair,TEVAR)由于其手术创伤小、临床结果良好的特点逐渐成为胸降主动脉多种病变的主要治疗方式,如Stanford B型夹层、胸降主动脉瘤、假性动脉瘤、透壁性主动脉溃疡等。升主动脉瘤(ascending aortic aneurysm)是升主动脉管壁局部异常扩张至正常直径1.5倍以上的病变,占所有胸主动脉瘤的45%,可导致主动脉夹层甚至瘤体破裂,若不行手术治疗,90%患者在5年内死亡。目前手术治疗仍以开放手术为主,采用管状移植物置换升主动脉伴有或者不伴主动脉瓣置换,尽管手术器材和技术不断改良,术后死亡率及并发症率仍较高,在高龄及有并存病患者中尤甚。因此学者开始探索腔内治疗在升主动脉的应用,已有报道采用传统直管型腔内移植物治疗升主动脉瘤,但仅为少数解剖条件达到腔内治疗要求的病例。由于受升主动脉本身的解剖学特点和传统的腔内隔绝移植物本身的限制,升主动脉瘤的微创腔内治疗在大多数患者中仍无法适用。升主动脉瘤腔内治疗的进一步发展需要在了解升主动脉病变形态特征的基础上提高腔内技术和改进腔内器具。因此,本研究旨在通过测量分析升主动脉瘤患者的解剖特征,进而在“瘤腔锚定”(Sac-anchoring)概念的基础上研制新型移植物系统,包括特殊结构的新型移植物、填充剂、输送系统等,既可解决升主动脉的固定区不足,又可避免移植物遮蔽分支血管,进而通过体外模拟实验评估其可行性。研究目的(1)测量并分析升主动脉瘤样扩张后的病变形态特征,根据其长度、直径、弯曲度及瘤体体积等参数,设计并采用合适材料制作出可用于升主动脉腔内治疗的球囊支架;(2)测试并筛选具有液固相变性质的高分子材料,改进其性能获得可用于填充球囊的填充剂;(3)设计并制作输送系统,与新型球囊支架组装为完整的移植物系统,在体外模型上完成模拟实验,证实其可行性。研究方法(1)从2012年1月-2014年12月在医院影像科行主动脉增强CT(Computed Tomography)检查的患者中,根据入排标准筛选70例升主动脉瘤患者的影像资料,测量并分析其长度、直径、弯曲度及瘤体体积等形态参数,根据各指标的集中、分布以及随性别年龄变化情况,为球囊支架的设计和制作提供参考数据;(2)与此同时,在目前临床使用的具有液固相变化特点的4种高分子材料中筛选1种可作为填充剂,通过与公司合作改进其配方以使其理化性能达到临床使用要求,并通过力学测试验证;(3)根据形态学研究所得结果及完成体外模拟实验的目的,设计并制作球囊支架及配套输送系统,压缩安装移植物并连接对应管道,组装成完整的移植物系统;(4)制作升主动脉瘤模型,在透视条件下完成移植物系统的导入、释放、填充、和回撤,记录实验过程,证实新型移植物系统的可行性。结果1.形态学测量所得关键指标如下:D1窦管结合部水平主动脉直径为37.0±6.0mm,D2升主动脉瘤体最大直径为52.6±6.0mm;L4升主动脉长度为92.56±14.79mm;L5瘤体的长度为81.52±21.01mm;T升主动脉即升主动脉弯曲度为0.23±0.10,T瘤体瘤体弯曲度为0.20±0.10;升主动脉瘤瘤体体积为171.87±58.26ml;2.筛选双组份加成型液体硅橡胶(additional liquid silicone rubber,ALSR)作为填充剂,改进其配方后获得硅橡胶产品型号(MED4420),黏度为20000cp,固化时间5min,固化后轴向拉伸应变为157.48%,拉伸应力为0.41MPa,周向拉伸应变为99.15%,拉伸应力为0.52MPa,力学性能满足要求;3.成功制作球囊支架初步样品,球囊材料选用乳胶,直径为70mm,容积为200ml,支架内径32mm,长度为75mm。成功制作集成多个功能组件(包括控制导丝组件、填充通道等)的输送系统。成功将移植物安装于输送系统,组装为完整移植物系统;4.成功制作瘤体长度为60mm,瘤体直径为63mm的升主动脉瘤体外模型,在透视条件下成功导入移植物至升主动脉,移植物释放后位置良好,展开顺利,填充过程顺利,填充压力为5atm,注射时间为1min,填充容积约为110ml。造影提示球囊填充后贴壁好,支架通畅。结论1.本研究所得加成型液体硅橡胶可作为填充剂,达到新型移植物的要求;2.本研究研制的新型移植物系统可制作组装,在体外模型上初步证实其可行性。
[Abstract]:Background Since Dake first reported the use of endovascular stent-graft in the treatment of thoracic descending aortic aneurysms in 1994, thoracic endovascular aortic repair (TEVAR) has gradually become the main treatment for many diseases of the thoracic descending aorta due to its small surgical trauma and good clinical results. Ascending aortic aneurysm (ASA) is an abnormal dilatation of the ascending aortic wall to more than 1.5 times the normal diameter, accounting for 45% of all thoracic aortic aneurysms, which can lead to aortic dissection or even rupture of the aneurysm, if not handled. 90% of the patients died within 5 years after operation. At present, open surgery is still the main treatment, and tubular graft replacement of ascending aorta with or without aortic valve replacement. Despite the continuous improvement of surgical equipment and techniques, the mortality and complication rate are still high, especially in the elderly and coexisting patients. Endovascular treatment of ascending aortic aneurysms has been reported using conventional straight-tube endovascular grafts, but only a small number of cases with anatomical conditions meet the requirements of endovascular treatment. Further development of endovascular treatment of ascending aortic aneurysms requires the improvement of endovascular techniques and instruments based on the understanding of the morphological characteristics of ascending aortic lesions. A new graft system was developed on the basis of the concept, including a new type of special structure graft, filler, delivery system, etc. It can not only solve the insufficiency of ascending aorta fixation area, but also avoid graft occlusion of branch blood vessels, and then evaluate its feasibility through in vitro simulation experiments. Objective (1) Measure and analyze the feasibility of ascending aortic aneurysm dilatation. According to the parameters of length, diameter, curvature and tumor volume, the balloon stent for ascending aorta was designed and fabricated with suitable materials; (2) Polymer materials with liquid-solid phase denaturation were tested and screened to improve their properties and obtain fillers for balloon filling; (3) Design and fabrication of balloon fillers. Methods (1) Seventy patients with ascending aortic aneurysm were screened according to the admission and exclusion criteria from January 2012 to December 2014 in the hospital imaging department for aortic contrast-enhanced CT (Computed Tomography). Imaging data were measured and analyzed for the length, diameter, curvature and tumor volume. According to the concentration, distribution of each index and the change with sex and age, reference data were provided for the design and manufacture of balloon stent. (2) At the same time, screening was used in four kinds of polymer materials with the characteristics of liquid-solid phase change. One of them can be used as filler to improve its physical and chemical properties to meet the clinical requirements through cooperation with the company and mechanical testing verification; (3) According to the results of morphological research and the purpose of completing in vitro simulation experiment, balloon stent and matching delivery system are designed and manufactured to compress and install the graft and connect the corresponding tube. (4) A model of ascending aortic aneurysm was made and the implant system was introduced, released, filled, and withdrawn under fluoroscopy. The experimental procedure was recorded to confirm the feasibility of the new graft system. The maximum diameter of D2 ascending aortic aneurysm was 52.6 (+ 6.0 mm); the length of L4 ascending aorta was 92.56 (+ 14.79 mm); the length of L5 ascending aorta was 81.52 (+ 21.01 mm); the curvature of T ascending aorta was 0.23 (+ 0.10); the curvature of T ascending aorta was 0.20 (+ 0.10); the volume of ascending aortic aneurysm was 171.87 (+ 58.26 ml); and 2. The silicone rubber product model (MED4420) was obtained by modifying the formulation with dditional liquid silicone rubber (ALSR) as filler. The viscosity was 20 000 cp, the curing time was 5 minutes, the axial tensile strain after curing was 157.48%, the tensile stress was 0.41 MPa, the circumferential tensile strain was 99.15%, the tensile stress was 0.52 MPa, and the mechanical properties met the requirements. For the preliminary sample of the stent, the balloon material was latex with a diameter of 70 mm, a volume of 200 ml, a stent inner diameter of 32 mm and a length of 75 mm. In vitro model of ascending aortic aneurysm with a diameter of 60 mm and 63 mm, the graft was successfully implanted into the ascending aorta under fluoroscopy. The graft was well positioned after release. The filling process was smooth. The filling pressure was 5 atm, the injection time was 1 min and the filling volume was about 110 ml. Additional liquid silicone rubber can be used as filler to meet the requirements of new grafts. 2. The new graft system developed in this study can be fabricated and assembled, and its feasibility has been preliminarily confirmed in vitro model.
【学位授予单位】：第二军医大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：R654.3
本文编号：2224714
[Abstract]:Background Since Dake first reported the use of endovascular stent-graft in the treatment of thoracic descending aortic aneurysms in 1994, thoracic endovascular aortic repair (TEVAR) has gradually become the main treatment for many diseases of the thoracic descending aorta due to its small surgical trauma and good clinical results. Ascending aortic aneurysm (ASA) is an abnormal dilatation of the ascending aortic wall to more than 1.5 times the normal diameter, accounting for 45% of all thoracic aortic aneurysms, which can lead to aortic dissection or even rupture of the aneurysm, if not handled. 90% of the patients died within 5 years after operation. At present, open surgery is still the main treatment, and tubular graft replacement of ascending aorta with or without aortic valve replacement. Despite the continuous improvement of surgical equipment and techniques, the mortality and complication rate are still high, especially in the elderly and coexisting patients. Endovascular treatment of ascending aortic aneurysms has been reported using conventional straight-tube endovascular grafts, but only a small number of cases with anatomical conditions meet the requirements of endovascular treatment. Further development of endovascular treatment of ascending aortic aneurysms requires the improvement of endovascular techniques and instruments based on the understanding of the morphological characteristics of ascending aortic lesions. A new graft system was developed on the basis of the concept, including a new type of special structure graft, filler, delivery system, etc. It can not only solve the insufficiency of ascending aorta fixation area, but also avoid graft occlusion of branch blood vessels, and then evaluate its feasibility through in vitro simulation experiments. Objective (1) Measure and analyze the feasibility of ascending aortic aneurysm dilatation. According to the parameters of length, diameter, curvature and tumor volume, the balloon stent for ascending aorta was designed and fabricated with suitable materials; (2) Polymer materials with liquid-solid phase denaturation were tested and screened to improve their properties and obtain fillers for balloon filling; (3) Design and fabrication of balloon fillers. Methods (1) Seventy patients with ascending aortic aneurysm were screened according to the admission and exclusion criteria from January 2012 to December 2014 in the hospital imaging department for aortic contrast-enhanced CT (Computed Tomography). Imaging data were measured and analyzed for the length, diameter, curvature and tumor volume. According to the concentration, distribution of each index and the change with sex and age, reference data were provided for the design and manufacture of balloon stent. (2) At the same time, screening was used in four kinds of polymer materials with the characteristics of liquid-solid phase change. One of them can be used as filler to improve its physical and chemical properties to meet the clinical requirements through cooperation with the company and mechanical testing verification; (3) According to the results of morphological research and the purpose of completing in vitro simulation experiment, balloon stent and matching delivery system are designed and manufactured to compress and install the graft and connect the corresponding tube. (4) A model of ascending aortic aneurysm was made and the implant system was introduced, released, filled, and withdrawn under fluoroscopy. The experimental procedure was recorded to confirm the feasibility of the new graft system. The maximum diameter of D2 ascending aortic aneurysm was 52.6 (+ 6.0 mm); the length of L4 ascending aorta was 92.56 (+ 14.79 mm); the length of L5 ascending aorta was 81.52 (+ 21.01 mm); the curvature of T ascending aorta was 0.23 (+ 0.10); the curvature of T ascending aorta was 0.20 (+ 0.10); the volume of ascending aortic aneurysm was 171.87 (+ 58.26 ml); and 2. The silicone rubber product model (MED4420) was obtained by modifying the formulation with dditional liquid silicone rubber (ALSR) as filler. The viscosity was 20 000 cp, the curing time was 5 minutes, the axial tensile strain after curing was 157.48%, the tensile stress was 0.41 MPa, the circumferential tensile strain was 99.15%, the tensile stress was 0.52 MPa, and the mechanical properties met the requirements. For the preliminary sample of the stent, the balloon material was latex with a diameter of 70 mm, a volume of 200 ml, a stent inner diameter of 32 mm and a length of 75 mm. In vitro model of ascending aortic aneurysm with a diameter of 60 mm and 63 mm, the graft was successfully implanted into the ascending aorta under fluoroscopy. The graft was well positioned after release. The filling process was smooth. The filling pressure was 5 atm, the injection time was 1 min and the filling volume was about 110 ml. Additional liquid silicone rubber can be used as filler to meet the requirements of new grafts. 2. The new graft system developed in this study can be fabricated and assembled, and its feasibility has been preliminarily confirmed in vitro model.
【学位授予单位】：第二军医大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：R654.3
【参考文献】
相关期刊论文 前1条
1 常光其;李晓曦;李松奇;胡作军;吕伟明;王深明;;腔内修复联合旁路手术治疗DeBakeyⅠ型升主动脉夹层[J];中国实用外科杂志;2005年12期
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