先心病封堵器研制现状

单击此处编辑母版标题样式,单击此处编辑母版文本样式,第二级,第三级,第四级,第五级,2020/11/3,*,先心病封堵器研制现状,第二军医大学附属长海医院心内科,2020/11/3,1,房间隔缺损器械,PFO,器械,室间隔缺损器械,动脉导管未闭器械,2020/11/3,2,房间隔缺损分型,中央型,下腔型,上腔型,混合型,2020/11/3,3,房间隔缺损封堵器的形状设计,双面伞形,2020/11/3,4,材料,形状记忆、超弹性,不锈钢,阻隔材料,涤纶，,PTFE,可吸收材料,聚乳酸,生物材料,2020/11/3,5,Sideris,房间隔缺损封堵器,1990,年,Sideris,发明纽扣式补片关闭,ASD,，其优点是能通过,F8,导管传送系统。临床应用已有,1000,余例，但操作复杂，补片易移位，残余分流率高，置入成功率仅,87,，目前仅在少数中心应用,。,2020/11/3,6,CardioSEAL,1991,年又在原蚌状夹关闭器的基础上研制出,CardioSEAL,新的一代封堵器，,Cardio-seal,封堵器采用具有抗疲劳特性的合金材料制成，它是由合金骨架和聚酯涤纶片组成的盘状结构，具有很好的安全性，但该方法需,11F,鞘，对,2,岁或体重,8kg,的小儿不适用，且封堵器型号少，只适用于,20mm,以下的缺损,。,2020/11/3,7,Cardioseal,封堵器,-,有产品无市场,中心定位差，金属臂可发生折断，残余分流发生率高,2020/11/3,8,应用,CardioSEAL,治疗,PFO,、房缺,近,2,年文献报道,172,例，成功率,79%,98%,。,Am J Cardiol. 2007 May 1;99(9):1316-20,J Am Coll Cardiol. 2006 Aug 1;48(3):538-44,.,2020/11/3,9,可吸收房间隔缺损封堵器,膜可以吸收,金属成分少，适应范围小,2020/11/3,10,多中心临床试验，,58,例中,57,例成功，,30,天和,6,月完全闭合率分别为,92,和,96,2020/11/3,11,可吸收封堵器,2020/11/3,12,螺旋型房间隔缺损封堵器,2020/11/3,13,螺旋型房间隔缺损封堵器,2020/11/3,14,2020/11/3,15,上报,FDA,的,3,项临床试验的资料,2020/11/3,16,房间隔缺损封堵器,Amplatzer,房间隔缺损封堵器,临床应用,13,年,疗效好，并发症发生率低,问题：,金属成份高、镍过敏,远期疗效不明了,2020/11/3,17,国产房间隔缺损封堵器,仿制型,细腰型,单,铆型房间隔缺损封堵器,带孔型房缺封堵器,全镍钛合金房间隔缺损封堵器,1999,年,ASD,封堵器应用于临床,2020/11/3,18,新型房间隔缺损封堵器,封堵器无不锈钢固定圈，更有利于上皮化,2020/11/3,19,新型房缺封堵器,2020/11/3,20,国产烤瓷封堵器,2020/11/3,21,特殊类型病变的器械,多孔型房缺,房间隔瘤房缺,2020/11/3,22,房间隔瘤,2020/11/3,23,正在研制和应用中的房缺封堵器,应用于房间隔瘤、多孔型房缺封堵器,2020/11/3,24,细腰型封堵器,2020/11/3,25,细腰型房间隔缺损封堵器,可提高多孔型房缺治疗的成功率,2020/11/3,26,PFO,闭合装置的研制,2020/11/3,27,PFO,的解剖,2020/11/3,28,封堵装置的设计,双面伞,类似房缺封堵器,单片状封堵器,缝合装置,焊接装置,2020/11/3,29,2020/11/3,30,PFO,封堵器,2020/11/3,31,新型,PFO,封堵器,2020/11/3,32,2020/11/3,33,2020/11/3,34,2020/11/3,35,2020/11/3,36,PFO,封堵器,Solysafe,封堵器,2020/11/3,37,2020/11/3,38,2020/11/3,39,2020/11/3,40,2020/11/3,41,2020/11/3,42,Premere,封堵器,2020/11/3,43,PFO,封堵装置,2020/11/3,44,封堵片,2020/11/3,45,2020/11/3,46,2020/11/3,47,2020/11/3,48,2020/11/3,49,2020/11/3,50,2020/11/3,51,2020/11/3,52,2020/11/3,53,PFO,射频闭合装置,2020/11/3,54,2020/11/3,55,缝合装置,2020/11/3,56,2020/11/3,57,2020/11/3,58,2020/11/3,59,室间隔缺损封堵器,膜周部室间隔缺损封堵器,肌部室间隔缺损封堵器,室间隔穿孔封堵器,2020/11/3,60,室间隔缺损的解剖,2020/11/3,61,封堵器的材料,镍钛合金，形状记忆和超弹性,阻隔膜,不锈钢,2020/11/3,62,2020/11/3,63,Amplatzer,膜周室间隔缺损封堵器,偏心型 ， 收放自如，有形状记忆功能,缺点：硬度高，记忆力强，术后远期三度房室传导阻滞的发生率高，规格单一,因并发症的发生率高，未能获,FDA,批准,2020/11/3,64,AGA device,AGA,(n=565),achievement ratio,91%95%,third degree A-V block,2%8%,permanent pace maker,12,（,3.8,),Catheter Cardiovasc Interv. 2006,，,68(4):620- 8(n=100),J Am Coll Cardiol. 2006 Jan 17;47(2):319-25(n=35),Eur Heart J. 2007 (n=430),death,1,2020/11/3,65,Amplatzer,肌部室间隔缺损封堵器,腰长 、形状记忆,肌部室间隔缺损患者少，仅占室间隔缺损的,1,2,，应用较少,2020/11/3,66,国产室间隔缺损封堵器,对称型,01,年临床应用，房室传导阻滞的发生率低，应用数量大,(,万余例,),2020/11/3,67,细腰型室间隔缺损封堵器,应用于多孔型室间隔缺损,2020/11/3,68,三孔型室缺，应用细腰封堵器,2020/11/3,69,囊袋型室缺,2020/11/3,70,多个细孔型室缺,2020/11/3,71,国产零边偏心型,应用于接近主动脉瓣的室间隔缺损,嵴内型室缺,2020/11/3,72,2020/11/3,73,嵴内型室间隔缺损,2020/11/3,74,2020/11/3,75,The datas on VSD occluder in China from 21 medical centers,9311patients with VSD underwent intervention,，,96.45% of patients were implanted occluders successfully.,Severe complcation 2.61%,，,mortality,0.05%,Late severe complication:,AVB-,TR,Enlarge of left ventricle,Up to 2008. 69 cAVB in China, only 3 need pacemaker,meeting/xxb-gf/2007/index.shtml,2020/11/3,76,其他类型的室缺封堵器,2020/11/3,77,1: Catheter Cardiovasc Interv. 2007 Jul 9;,Lim DS, et al,。,应用,CardioSEAL,治疗高危室缺的,18,个中心登记,55,例，,61,次,VSD,封堵操作,成功率,92,残余漏,74%,封堵器脱落,4%,5/81 devices surgically explanted (6% explant rate),2020/11/3,78,2020/11/3,79,2020/11/3,80,动脉导管未闭封堵器,Amplatzer PDA,封堵器,成角封堵器,2020/11/3,81,目前应用的封堵器,弹簧圈,镍钛合金封堵器,2020/11/3,82,小,PDA,2020/11/3,83,成,角封堵器的应用,2020/11/3,84,PDA,直径与主动脉接近,应用室缺封堵器成型差,应用直径,14mm,的封堵器,未能完全张开,应用腰部直径,12mm,的室缺,封堵器，可封堵出口,A,B,C,D,2020/11/3,85,应用成角封堵器,(14mm),成功封堵,封堵器完全覆盖入口,2,岁,angled occluder,2020/11/3,86,成角封堵器治疗大,PDA,2020/11/3,87,小结,介入治疗的进展是,想与做,结合的结果,国内创新产品少，高端产品少,先心病介入治疗产品是心脏介入治疗产品中国产化最成功的范例 ，积累了成功的经验，有较好的发展前景,2020/11/3,88,谢谢！,2020/11/3,89,