CN113456172B - 一种充气式近端取栓导管 - Google Patents
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Abstract
一种近端取栓导管,包括内管和外管,所述内管活动套设在所述外管中,所述内管的上端端部与所述外管的上端端部一体式连接从而封闭外管的上端开口,内管的上端开口与外界连通;外管上部设有变形管段,环绕变形管段四周设有若干条轴向延伸的切痕,任意相邻的两条切痕之间形成变形条;所述变形管段外覆设有弹性密封膜;所述外管的内腔连通有充气管道。本发明取栓导管通过变形管段弯曲隆起增大体积,使裹覆于其外的弹性密封膜随变形管段膨胀充盈,进而与血管壁过盈配合,以阻断血液流通,提高抽吸导管端头与血栓之间的真空度,提高抽吸导管的抽吸取栓效果;另外通过充气管道对外管内腔充气,使弹性密封膜更加充盈膨胀,对血流的阻断效果更优。
Description
技术领域
本发明涉及医疗器械技术领域,具体为一种充气式近端取栓导管。
背景技术
卒中是导致人类致残和致死的主要疾病之一,其死亡率已占全国居民总死亡率的22.3%,急性缺血性卒中(acute ischemic stroke,AIS)约占全部卒中的80%。AIS治疗的关键在于尽早开通阻塞血管,挽救缺血半暗带。目前被证实有效的AIS早期血管再通的治疗方法主要是静脉溶栓和机械取栓。但静脉溶栓有严格的时间要求,发病时间小于4.5小时,大部分患者就诊时均超过该时间,同时对于大血管闭塞的病例效果不佳,再通率仅13%,因此机械取栓是最直接也是最有效的开通血管的方式。对于不同年龄、不同病因及堵塞的不同血管血管直径,每位患者的取栓过程也不尽相同。其中心房颤动导致的心源性脑栓塞较为常见,因为血栓量较大且较硬而取栓困难。
机械吸栓术采用抓捕血栓及负压吸引的方式,通过微导管将支架型取栓器送至血管栓塞处并令其释放,支架型取栓器自行展开与血栓嵌合,然后回收取栓器,将血栓带出,另外微导管外设有抽吸导管,抽吸导管为直径5F-6F的管状导管,直径小于血管内径,没有阻断血流,悬浮于血管内。因为没有渐变结构,导致大而硬的栓子无法被取栓支架回收到中间导管内,并且栓子在回收过程存在被导管切割而逃逸的可能,从而导致取栓失败。
现有技术中也有使用传统囊体,充气使其膨胀能达到一定程度短暂阻断血流的作用,例如授权公告号为CN210447130U,公开了一种临床血管外科血栓吸取装置,其导管外壁设有一圈弹性密封膜,该弹性密封膜覆盖的部分导管壁内陷形成空腔,该空腔连通有充气通道,充气使弹性密封膜膨胀,以将血液隔开,但是一来该气囊内部没有支架支撑形状,容易被血液挤压内陷,还是存在血流通过的情况,导致取栓效果差,二来在内部压力有安全限度的条件下,膨胀的囊体的膨胀半径也极其有限,因此其与血管壁之间也达不到很好的密封接触效果。
发明内容
本发明的目的在于提供一种充气式近端取栓导管,可与血管管壁之间形成良好的密封接触,阻断血液流通,提高抽吸导管端头与血栓之间的真空度,提高抽吸导管的抽吸取栓效果。
为实现上述目的,本发明提供如下技术方案:
一种近端取栓导管,包括内管和外管,所述内管活动套设在所述外管中,所述内管的上端端部与所述外管的上端端部一体式连接从而封闭所述外管的上端开口,所述内管的上端开口与外界连通;所述外管上部设有变形管段,环绕变形管段四周设有若干条轴向延伸的切痕,任意相邻的两条切痕之间形成变形条;所述变形管段外覆设有弹性密封膜;所述外管的内腔连通有充气管道。
具体的,所述变形管段的变形条为预弯成型的记忆金属条。
具体的,所述变形管段的底端套箍有固定环,所述弹性密封膜的底端箍紧于所述固定环内。
具体的,所述弹性密封膜为橡胶套。
具体的,所述充气管道沿所述外管长度方向延伸至所述外管靠近所述变形管段的一端。
具体的,所述内管与所述外管下端的连接处套设有密封圈,起密封作用时,所述密封圈的端面与所述外管的下端端面贴合。
具体的,还包括有用于保持内管和外管之间位置相对不动的限位扣,所述限位扣箍设于所述内管外。
与现有技术相比,本发明的有益效果是:本发明的取栓导管,包括内管和外管,内管设于外管内,外管上部设有变形管段,该变形管段外套设有弹性密封膜,变形管段扩张体积对弹性密封膜进行支撑,利用外管与内管之间不同的位置关系可改变对变形条的挤压程度进而能够控制整个漏斗状形态下的变形管段上漏斗的开度,从而能够更好的使得弹性密封膜与血管壁接触,则阻断血液流通,提高导管端头与血栓之间的真空度,提高导管负压抽吸效果,以顺利将血栓抽出,且通过变形管段的支撑,弹性密封膜不易在血压作用下被血液挤压变形,其阻断效果更好;另外,外管内腔还连通有充气管道,对内部进行充气,使弹性密封膜充分膨胀,这样可防止变形管段扩张时,变形管段的变形条之间存在间隙,弹性密封膜会在间隙部内陷。
附图说明
图1为本发明的结构示意图;
图2为本发明的剖视图一;
图3为本发明的剖视图二;
图4为本发明的剖视图三;
图5为本发明取栓导管伸入血管中变形管段未扩张时的状态图;
图6为本发明取栓导管伸入血管中变形管段扩张时的状态图一;
图7为本发明取栓导管伸入血管中变形管段扩张时的状态图二;
图8为本发明所述充气管道未对外管内腔充气时的结构示意图;
图9为本发明图8中A处的结构放大图;
图10位本发明所述充气管道对外管内腔充气时的结构示意图。
图中:1、内管;2、外管;3、弹性密封膜;4、固定环;5、限位扣;6、血栓;7、血液;8、充气管道;9、密封圈;21、变形管段;211、变形条; 23、隔板。
具体实施方式
下面将结合本发明实施例中的附图,对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
术语中“上”、“下”等指示的方位或位置关系为基于附图所示的方位或位置关系,仅是为便于描述和简化描述,不是指示或暗示特定的方位,因此不能理解为对本发明的限制。
请参阅图1-5,本发明所揭示的是一种充气式近端取栓导管,包括内管1和外管2,该内管1和外管2均为中空结构,内管1活动套设在外管2中,所述内管1的上端端部与外管2的上端端部连接一体,从而封闭外管2的上端开口,所述内管1的上端开口开放与外界连通,血栓6从内管1的上端开口进入通过内管1抽吸取出;
所述外管2上部设有变形管段21,环绕变形管段21四周设有若干条轴向延伸的切痕,任意相邻的两条切痕之间形成变形条211,如图2-4所示,将外管2相对内管1往上端方向推动时,变形条211受到外力作用被迫弯曲并向外侧隆起,直至最后形成漏斗状形态;该变形管段21外覆设有弹性密封膜3,该弹性密封膜3封闭包裹变形管段21,所述变形管段21的变形条211弯曲隆起增大体积后,弹性密封膜3被撑大膨胀接触血管壁,以阻挡血液7流通;
具体的,如图5所示,取栓导管进入血管后,此时,血液7在外管2的外侧壁流通,此时内管1对血栓6进行抽吸时,会连同血管中的血液一同抽吸,则影响对血栓6的抽吸效果;如图6-7所示,固定内管1不动,将外管2往远端方向推动,使变形管段21的变形条211被迫弯曲并向外侧隆起扩张,直至最后形成漏斗状形态,将裹覆于其外的弹性密封膜3撑大,使其弹性密封膜3与血管壁接触,加上血管具有弹性,血管壁对弹性密封膜3具有相对的压力,则在变形管段21的扩张力和血管壁的压力相对作用下,弹性密封膜3与血管壁紧密配合,从而封闭血管,阻断血液7不会流入“漏斗”与血栓之间的血管中,则使血栓6部位更容易形成负压状态,则可更快速的抽吸血栓6。
变形管段21扩张时,变形管段21的变形条211之间存在间隙,则弹性密封膜3会在间隙部出现内陷的情况,如图7-10所示,则弹性密封膜3内陷的区域,有部分血液7流通,则会影响血栓6的抽吸效果;为了使弹性密封膜3更充分的膨胀,外管2的内腔连通有充气管道8,通过充气管道8对外管2的内腔进行充气,如图7所示,在不断充入到外管2内腔中气体的作用下,弹性密封膜3会得到充分的膨胀,使弹性密封膜3膨胀到接触血管壁并将血管封闭,阻断血液不会通过血栓部位,使血栓抽吸效果更好。为更快速有效地对弹性密封膜3内部充气,充气管道8可沿外管2长度方向延伸至外管2靠近变形管段21的一端,外管2内壁靠近变形管段21处还可设置有隔板23,隔板23将外管2的内腔分隔成上下两腔,上腔较小且变形管段21位于上腔,该隔板23与内管1的外壁间隙配合,充气管道8贯通隔板23对外管2的上腔进行充气,可快速对上腔填充气体并使弹性密封膜3快速膨胀;所述内管1与外管2近端的连接处套还可设有密封圈9,起密封作用时,该密封圈9的端面与外管2的近端端面贴合,这样可防止气体从外管2与内管1的外壁的连接处泄露;此外,本发明亦可使用液体对外管2的内腔进行填充,使弹性密封膜3得到更充分的膨胀。
其中,变形管段21的变形条211为记忆金属条,该变形条211预先预弯成型,这样变形条211形成记忆,朝预弯的弧度弯曲;为防止外管2的切缝在变形管段21扩张时,朝外管2的近端方向延伸撕裂,则所述变形管段21的底端套箍有固定环4,弹性密封膜3的底端箍紧于固定环4内。
进一步的,所述弹性密封膜3为橡胶套。
为固定变形管段21的弯曲隆起形态,还可设有一限位扣5,该限位扣5可箍设于内管1的外侧壁上以卡住外管2的下端端部,以保持内管1和外管2之间位置相对不动,防止外管2回缩。
工作原理:保持内管1不动,握住外管2的下端,将外管2相对内管1往上端方向推动,如图5-7,变形条211受到外力作用被迫弯曲并向外侧隆起,直至最后形成漏斗状形态,弹性密封膜3被撑大膨胀接触血管壁,以阻挡血液7流通,使用限位扣5箍设于内管1的外侧壁上以卡住外管2的下端端部,限定外管2的位置,使其不会回缩,使外管2上部的变形条211保持弯曲隆起状态,再将气体从充气管道8通入,使弹性密封膜3得到更充分的膨胀,防止在两条变形条211之间的空隙内陷,最后通过内管1对血栓6进行抽吸。
尽管参照前述实施例对本发明进行了详细的说明,对于本领域的技术人员来说,其依然可以对前述各实施例所记载的技术方案进行修改,或者对其中部分技术特征进行等同替换,凡在本发明的精神和原则之内,所作的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。
Claims (1)
1.一种充气式近端取栓导管,其特征在于:包括内管(1)和外管(2),所述内管(1)活动套设在所述外管(2)中,所述内管(1)的上端端部与所述外管(2)的上端端部一体式连接从而封闭所述外管(2)的上端开口,所述内管(1)的上端开口与外界连通;所述外管(2)上部设有变形管段(21),环绕变形管段(21)四周设有若干条轴向延伸的切痕,任意相邻的两条切痕之间形成变形条(211);所述变形管段(21)外覆设有弹性密封膜(3);所述外管(2)的内腔连通有充气管道(8);
所述变形管段(21)的底端套箍有固定环(4),所述弹性密封膜(3)的底端箍紧于所述固定环(4)内;
所述充气管道(8)沿所述外管(2)长度方向延伸至所述外管(2)靠近所述变形管段(21)的一端;
所述变形管段(21)的变形条(211)为预弯成型的记忆金属条,所述弹性密封膜(3)为橡胶套;
所述内管(1)与所述外管(2)下端的连接处套设有密封圈(9),起密封作用时,所述密封圈(9)的端面与所述外管(2)的近端端面贴合;
还包括有用于保持内管(1)和外管(2)之间位置相对不动的限位扣(5),所述限位扣(5)箍设于所述内管(1)外;
固定内管(1)不动,将外管(2)往远端方向推动,使变形管段(21)的变形条(211)被迫弯曲并向外侧隆起扩张直至最后形成漏斗状形态,将裹覆于变形条(211)外的弹性密封膜(3)撑大使其弹性密封膜(3)与血管壁接触。
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