CN111529001A - 一种带金属支架的胆道穿刺引流管 - Google Patents
一种带金属支架的胆道穿刺引流管 Download PDFInfo
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Abstract
一种带金属支架的胆道穿刺引流管属于医疗器械制造技术领域。本发明包括引流管、引流管延长管、外套管、内套管、穿刺针;引流管头部为钛合金金属支架,尾部末端外壁有螺纹;引流管延长管为硬质塑料管;外套管呈锥形的头部顶端开口,壁上设有纵行连续侧孔,连接线连接体部内侧壁,经头部顶端开口引出,经尾部连接线通过孔进入体部管腔内,尾部为硬质塑料管;内套管头部呈菱形,尾端末端表面设有螺纹;穿刺针为金属针,头端设有塑料阻力块,尾端设有帽状接头,帽状接头内壁有螺纹,将该结构旋在内套管末端上。本发明的优点是,从经皮经肝胆管穿刺途径置入金属支架治疗胆管狭窄,保护了十二指肠乳头括约肌,而且置入的金属支架能够经置入通道取出。
Description
技术领域
本发明属于医疗器械制造技术领域,涉及一种微创医疗技术及手术器械,用于经皮经肝胆管穿刺治疗良恶性肝外胆管狭窄的微创手术器械,具体地说是一种带金属支架的胆道穿刺引流管。
背景技术
肝外胆管狭窄是临床一种常见病和多发病,包括炎性胆管狭窄、损伤性胆管狭窄、肝移植术后胆管吻合口狭窄、恶性胆管狭窄等,胆管狭窄可引起狭窄上方胆道压力升高、胆汁排泄不畅,引起寒战高热、黄疸及上腹部疼痛症状,持续性梗阻可引起胆汁淤积性肝硬化、肝功能衰竭,甚至危及患者生命。
对于肝外胆管狭窄的治疗包括外科手术、内镜及介入治疗,其中外科手术风险大,胆肠吻合术后并发症多;内镜手术创伤小,需切开乳头括约肌,存在术后出血、急性胰腺炎、反流性胆管炎等并发症,对于上消化道狭窄、胃肠手术后再次行内镜手术难度较大,失败率较高。三种治疗方案中,介入治疗创伤最小,在局麻下即可完成,即可作为首选防范,也可作为外科手术及内镜手术治疗失败的替补防范。
介入治疗胆管狭窄的方法包括胆道外引流、胆道塑料支架置入或胆道金属支架置入,以解除狭窄,恢复胆汁的通畅引流。三种引流方式中胆道外引流管只能解除黄疸,不能解除狭窄,大量胆汁的丢失会导致纳差,水、酸碱及离子紊乱;胆道塑料置入次之,但是取出支架后再狭窄率较高;胆道金属支架置入是治疗肝外胆管狭窄可以获得更大的扩张直径,一般用于恶性肝外胆管狭窄的治疗,很少用于良性胆管狭窄的治疗,因为经皮经肝穿刺途径难易将置入的金属支架取出。内镜治疗胆管狭窄确定置入胆道金属支架通畅时间更长、狭窄复发率更低,效果优于塑料支架。
发明内容
本发明的目的就是提供一种经皮经肝胆管穿刺途径治疗胆管狭窄的带金属支架的胆道穿刺引流管。
本发明由引流管1、引流管延长管2、外套管3、内套管4和穿刺针5构成;其中,引流管1、引流管延长管2、外套管3和内套管4均为单通道引流管;引流管1分为头部6、体部7和尾部8,其中,头部6为金属支架,体部7为软管,体部7管壁上设有侧孔9,尾部8为硬管,尾部8末端外壁有螺纹;引流管延长管2为硬管,引流管延长管2头部与引流管1尾部通过连接线活动连接;外套管3包括头部10、体部11、尾部12和连接线13,头部10呈锥形,顶端设有开口,头部10管壁上设有纵行连续侧孔14,连续侧孔14从头部10顶端到头部10底端,连接线13一端连接在体部11内侧壁上,另一端经头部10顶端开口引出,经头部10底端管壁上设置的连接线通过孔入体部11管腔内,从尾部12引出,尾部12为硬管;内套管4分为头部15、体部16和尾部17,头部15呈菱形,体部16为软管,尾部17为硬管,尾部17末端表面设有螺纹;穿刺针5为金属针,头端设有阻力块18,尾端设有帽状接头19;穿刺针5穿过内套管4,帽状接头19内壁设置的螺纹旋在内套管4末端上,用连接线连接的引流管1和引流管延长管2套在内套管4上,外套管3套在引流管1和引流管延长管2上;
外套管3长40-60cm,头部10长10cm,顶端外径6.5Fr,内径6Fr,体部11和尾部12外径9Fr,内径8.5Fr,尾部12长5-10cm;
外套管3尾部12为硬质塑料管;
引流管1长40-60cm,其中,头部6金属支架弹开后长4-8cm,直径6-10mm,体部7和尾部8外径为8Fr,内径7Fr,尾部8长3-5cm;引流管延长管2长60cm,外径为8Fr,内径7Fr;
引流管1头部6为钛合金丝编织的金属支架,尾部8为硬质塑料管;引流管延长管2为硬质塑料管;
引流管1体部7管壁上设置的侧孔9是3-5个;
内套管4长100-120cm;头部15最大处外径6.5Fr,长1.5cm;体部16和尾部17外径5.5Fr,内径4.5Fr,尾部17长5-10cm;
内套管4尾部17为硬质塑料管,
穿刺针5长100-120cm,外径4Fr;
穿刺针头端设有的阻力块18材质是塑料,尾端设有的帽状接头19材质是硬质塑料。
本发明所达到的有益效果是:
1.本发明组装后能够直接穿刺进入扩张的胆管内;
2.本发明中金属支架能够对狭窄进行有效支撑,同时能外引流胆汁;
3.本发明中金属支架与外引流管相连,固定外引流管可预防金属支架移位;
4.本发明中的金属支架与树脂外引流管相连,取出外引流管的同时可将金属支架取出。
附图说明
图1是本发明中引流管的结构示意图,
图2是本发明中引流管延长管的结构示意图,
图3是本发明中外套管的结构示意图,
图4是本发明中内套管的结构示意图,
图5是本发明中穿刺针的结构示意图,
图6是本发明组装后的示意图,
图7是本发明经皮置入到胆管内的示意图,
图8是本发明退出穿刺针并置入导丝的示意图,
图9是本发明回连接线使外套管前段管壁侧壁撕开的示意图,
图10是退出外套管后引流管上金属支架完全释放开的示意图,
图11是退出内套管和导丝后引流管呈工作状态的示意图,
其中,1.引流管,2.引流管延长管,3.外套管,4.内套管,5.穿刺针,6.头部,7.体部,8.尾部,9.侧孔,10.头部,11.体部,12.尾部,13.连接线,14.纵行连续侧孔,15.头部,16.体部,17.尾部,18.阻力块,19.帽状接头,20.导丝。
具体实施方式
下面结合附图和具体实施方式对本发明作进一步详细的说明。
本发明由引流管1、引流管延长管2、外套管3、内套管4和穿刺针5构成;其中,引流管1、引流管延长管2、外套管3和内套管4均为单通道引流管;引流管1分为头部6、体部7和尾部8,其中,头部6为钛合金丝编织的金属支架,引流管延长管2为硬质塑料管,体部7为软管,体部7管壁上设有5个侧孔9,尾部8为硬质塑料管,尾部8末端外壁有螺纹;引流管延长管2为硬质塑料管,引流管延长管2头部与引流管1尾部通过连接线活动连接,引流管延长管2头端左右两个对称的侧孔,引流管1尾部左右两侧对称的侧孔,分别使用连接线将引流管1和引流管延长管2一侧的侧孔固定在一起;外套管3包括头部10、体部11、尾部12和连接线13,头部10呈锥形,顶端设有开口,头部10管壁上设有纵行连续侧孔14,连续侧孔14从头部10顶端到头部10底端,连接线13一端连接在体部11内侧壁上,另一端经头部10顶端开口引出,经头部10底端管壁上设置的连接线通过孔入体部11管腔内,从尾部12引出,尾部12为硬质塑料管;内套管4分为头部15、体部16和尾部17,头部15呈菱形,体部16为软管,尾部17为硬质塑料管,尾部17末端表面设有螺纹;穿刺针5为金属针,头端设有塑料阻力块18,尾端设有硬质塑料帽状接头19;穿刺针5穿过内套管4,帽状接头19内壁设置的螺纹旋在内套管4末端上,用连接线连接的引流管1和引流管延长管2套在内套管4上,外套管3套在引流管1和引流管延长管2上;
外套管3长60cm,头部10长10cm,顶端外径6.5Fr,内径6Fr,体部11和尾部12外径9Fr,内径8.5Fr,尾部12长5cm;
引流管1长60cm,其中,头部6金属支架弹开后长8cm,直径10mm,体部7和尾部8外径为8Fr,内径7Fr,尾部8长5cm;引流管延长管2长50cm,外径为8Fr,内径7Fr;
内套管4长119cm;头部15最大处外径6.5Fr,长1.5cm;体部16和尾部17外径5.5Fr,内径4.5Fr,尾部17长5cm;
穿刺针5长120cm,外径4Fr。
1.直接胆管穿刺:
本装置组装后,在超声或X线监视下将本装置穿刺进入到胆管内,退出穿刺针5,经内套管4注入造影剂完整显示肝外胆管及狭窄部位,经内套管4置入导丝20并进入狭窄远端胆管或十二指肠内,在导丝20引导下是本装置越过狭窄,X线透视下调整头部6金属支架位置,固定引流管连接管2,回拉连接线13使外套管3头端侧壁被撕开,退出外套管3,头部6金属支架释放,固定引流管延长管2并退出内套管4,剪断引流管1与引流管延长管2之间的连接线,引流管1缝合固定在穿刺点旁腹壁上,将引流管1尾部接引流袋。
2.经皮经肝胆管穿刺后直管:
在超声或X线监视下经原经皮经肝胆管穿刺引流管置入导丝20,保留导丝20并退出原引流管,将组装的本装置中的穿刺针5退出,在导丝20引导下是本装置越过狭窄,X线透视下调整头部6金属支架位置,固定引流管连接管2,回拉连接线13使外套管3头端侧壁被撕开,退出外套管3,头部6金属支架释放,固定引流管延长管2并退出内套管4,剪断引流管1与引流管延长管2之间的连接线,引流管1缝合固定在穿刺点旁腹壁上,将引流管1尾部接引流袋。
Claims (10)
1.一种带金属支架的胆道穿刺引流管,其特征在于,由引流管(1)、引流管延长管(2)、外套管(3)、内套管(4)和穿刺针(5)构成;其中,引流管(1)、引流管延长管(2)、外套管(3)和内套管(4)均为单通道引流管;引流管(1)分为头部(6)、体部(7)和尾部(8),其中,头部(6)为金属支架,体部(7)为软管,体部(7)管壁上设有侧孔(9),尾部(8)为硬管,尾部(8)末端外壁有螺纹;引流管延长管(2)为硬管,引流管延长管(2)头部与引流管(1)尾部通过连接线活动连接;外套管(3)包括头部(10)、体部(11)、尾部(12)和连接线(13),头部(10)呈锥形,顶端设有开口,头部(10)管壁上设有纵行连续侧孔(14),连续侧孔(14)从头部(10)顶端到头部(10)底端,连接线(13)一端连接在体部(11)内侧壁上,另一端经头部(10)顶端开口引出,经头部(10)底端管壁上设置的连接线通过孔入体部(11)管腔内,从尾部(12)引出,尾部(12)为硬管;内套管(4)分为头部(15)、体部(16)和尾部(17),头部(15)呈菱形,体部(16)为软管,尾部(17)为硬管,尾部(17)末端表面设有螺纹;穿刺针(5)为金属针,头端设有阻力块(18),尾端设有帽状接头(19);穿刺针(5)穿过内套管(4),帽状接头(19)内壁设置的螺纹旋在内套管(4)末端上,用连接线连接的引流管(1)和引流管延长管(2)套在内套管(4)上,外套管(3)套在引流管(1)和引流管延长管(2)上。
2.根据权利要求1所述的一种带金属支架的胆道穿刺引流管,其特征在于,外套管(3)长40-60cm,头部(10)长10cm,顶端外径6.5Fr,内径6Fr,体部(11)和尾部(12)外径9Fr,内径8.5Fr,尾部(12)长5-10cm。
3.根据权利要求1或2所述的一种带金属支架的胆道穿刺引流管,其特征在于,外套管(3)尾部(12)为硬质塑料管。
4.根据权利要求1所述的一种带金属支架的胆道穿刺引流管,其特征在于,引流管(1)长40-60cm,其中,头部(6)金属支架弹开后长4-8cm,直径6-10mm,体部(7)和尾部(8)外径为8Fr,内径7Fr,尾部(8)长3-5cm;引流管延长管(2)长60cm,外径为8Fr,内径7Fr。
5.根据权利要求1或4所述的一种带金属支架的胆道穿刺引流管,其特征在于,引流管(1)头部(6)为钛合金丝编织的金属支架,尾部(8)为硬质塑料管;引流管延长管(2)为硬质塑料管。
6.根据权利要求1或4所述的一种带金属支架的胆道穿刺引流管,其特征在于,引流管(1)体部(7)管壁上设置的侧孔(9)是3-5个。
7.根据权利要求1所述的一种带金属支架的胆道穿刺引流管,其特征在于,内套管(4)长100-120cm;头部(15)最大处外径6.5Fr,长1.5cm;体部(16)和尾部(17)外径5.5Fr,内径4.5Fr,尾部(17)长5-10cm。
8.根据权利要求1或7所述的一种带金属支架的胆道穿刺引流管,其特征在于,内套管(4)尾部(17)为硬质塑料管。
9.根据权利要求1所述的一种带金属支架的胆道穿刺引流管,其特征在于,穿刺针(5)长100-120cm,外径4Fr。
10.根据权利要求1或9所述的一种带金属支架的胆道穿刺引流管,其特征在于,穿刺针头端设有的阻力块(18)材质是塑料,尾端设有的帽状接头(19)材质是硬质塑料。
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CN113750354A (zh) * | 2021-09-08 | 2021-12-07 | 北京清华长庚医院 | 带支架的胆道内引流装置 |
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CN113750354B (zh) * | 2021-09-08 | 2023-08-22 | 北京清华长庚医院 | 带支架的胆道内引流装置 |
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