CN113786549B - 一种用于经皮微创腔静脉插管术的插管 - Google Patents

一种用于经皮微创腔静脉插管术的插管 Download PDF

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CN113786549B
CN113786549B CN202010474339.0A CN202010474339A CN113786549B CN 113786549 B CN113786549 B CN 113786549B CN 202010474339 A CN202010474339 A CN 202010474339A CN 113786549 B CN113786549 B CN 113786549B
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cannula
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桑吉夫·乔杜里
彼得·苏瓦斯基
玛尔塔·马库奇
雅切克·奥尔谢夫斯基
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Medina Co ltd
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Abstract

一种用于经皮微创腔静脉插管术的塑料插管，所述插管(1)具有三个纵向腔室，包括主腔室(1a)、第一侧腔室(1a1)和第二侧腔室(1a2)；还具有至少一个确保内径恒定的加强部，在其远端侧具有朝向末端逐渐变窄的圆端(2)，圆端(2)具有纵向孔(4)，纵向孔(4)的尺寸允许静脉血自由流动；还具有球囊(6)。球囊下方的加强部的一段弯曲成约90°的角度α。插管(1)在近端侧终止为柔性锥体(3)，其将插管紧密密封，在锥体(3)内部具有关闭主腔室(1a)的阀(12)和连接第一侧腔室(1a1)的用于向球囊(6)充注的端口(5)，此外在第二侧腔室(1a2)内具有可移除的加固件(8)，其远端在最极端位置到达球囊(6)的底部，当加固件(8)的近端穿过锥体(3)引出时，插管(1)的加强部保持形状记忆。

Description

一种用于经皮微创腔静脉插管术的插管
技术领域
本发明涉及一种用于经皮微创腔静脉插管术的插管(cannula)。
背景技术
心脏外科手术需要使心脏摆脱泵血的任务，从而将患者体内循环的血流连接到体外循环系统中的人造肺心。该装置做机械功产生压力从而使血液被泵送通过周围血管并对静脉血充氧。体外循环系统是一种具有连接至心脏主要血管的插管的装置。
近年来，越来越多地选择微创方法，其中整个手术过程是经由肋间间隙处的微小皮肤切口进行的。
对于插管术而言，至关重要的是隔离方法，即关闭插管周围的主要静脉以使血液仅在插管内部流动而不通过血管腔。标准外科手术(胸骨切开术)通常是通过所谓的止血带从外部关闭的。但是，在微创手术中这可能非常困难，甚至是不可能的，这涉及在内窥镜摄像头的控制下使用特殊的长器械进入心脏和瓣膜。这种手术涉及连接体外循环的不同方式、不同的插管部位(腹股沟处的静脉和股动脉)，因此需要完全不同的插管。已知用于微创手术的静脉插管在其远端部配备有球囊或特殊的凸缘，能够使得静脉如同从外部夹紧一样被有效关闭。通常插入两个插管，一个经股静脉插入下腔静脉，另一个经颈静脉插入下腔静脉。
WO0007654A1的说明书公开了一种插管，其由弯曲的远端部、弹性中央部和近端部组成。在远端部安装有球囊以便于将插管锚固在血管中。在中央部具有一个位于外周的第二球囊，通常为圆柱形球囊，由于泵送的原因其增大了插管腔的直径。用于向两个球囊充注的两个端口位于近端部。插管的远端部的曲率优选为约90°。
WO9930766A1公开了一种在因心脏停搏导致暂时性心脏骤停的手术中使用的插管。利用位于插管远端的可延伸切割刀片将插管置入患者的主动脉中。在制造切口后，刀片缩回插管中，然后从插管内腔中取出。同时，将位于插管出口附近的密封球囊进行泵送。插管以其原始状态置入纵向凸缘中，在插管滑出后呈现预定的弯曲形状。用于向主动脉施用物质或从插管内腔取出堵塞物的端口位于近端。
US6129713A公开了一种插管，在其外部配备有刚性套管针用作将插管置入血管的引导件。用于切割血管壁的刀片和在刀片侧带有保护盖的可充注密封球囊位于套管针的远端。将套管针放置在选定的位置后，将插管拔出并呈现预定形状。
当前使用的解决方案涉及必须将插管和静脉绑扎以确保牢固的机械连接。
发明内容
一种用于经皮微创腔静脉插管术的插管是塑料管，其具有至少一个锥形或圆形的端部并配备有至少一个允许血液进入其内部的流入开口。根据本发明的解决方案的特征在于，所述插管具有三个纵向腔室，包括主腔室、第一侧腔室和第二侧腔室，至少一个确保内径恒定的加强部以及球囊，所述插管在远端侧具有朝向末端变窄的圆端，在圆端中具有至少一个纵向孔，孔尺寸能够使静脉血自由流入。所述插管的加强部位于球囊的下方，其部分弯曲成约90°的角α。所述插管在近端侧终止为柔性锥体，其将插管轻巧紧密地密封，在其内部具有一个关闭主腔的阀和一个连接至第一侧腔室的用于对球囊充注的端口。在第二侧腔室内部设置有可移除的加固件，加固件的远端在最极端的位置到达球囊的底部，当加固件的近端穿过锥体被引出时，插管的加强部保持形状记忆。
优选地，所述纵向孔在圆端处的长边与插管的轴线重合。
在一个优选实施方案中，所述纵向孔围绕圆端的圆周均匀分布。
优选地，所述纵向孔围绕圆端的周边均匀分布成两行，并且在两行之间彼此同步偏移。
在一个优选实施方案中，所述插管利用金属丝螺线管加强。
在一个优选实施方案中，所述插管利用金属带螺线管加强。
优选地，所述插管利用任意编织的金属丝网加强。
优选地，在所述插管的圆端内部安装有两件式一体式针头。所述针头由通道形式的锐部和位于锐部内的圆部组成。所述圆部具有一个以上的入口，并且该两部均配有独立的弹簧并与触发按钮相连。
优选地，所述插管包括管心针，所述管心针在中心延伸穿过插管，所述管心针的远端到达圆端的出口并且近端穿过锥体被引导到外部，其还配备有人体工学手柄，所述手柄具有符合人体工学的蝴蝶结形式。
在一个优选的实施方案中，所述锥体可移除地连接到插管。
根据本发明的解决方案的主要优点在于，在微创心脏手术期间提供紧密的保护。该插管可以用于各种手术技术中。这对于手术者非常方便，并且显著减少了手术的手术区域准备时间。另外，使用该插管完全不需要切割，或者使切口最小化，甚至小于插管的直径。
插管的锥端允许将插管方便地置入血管内，然后轻松地插入下一切口。移除该锥体可扩大球囊的注入端口，该端口配有短软管。
插管的设计允许创建适应不同需求的多种版本，取决于手术者选择的手术技术，从最简单、最便宜的版本到旨在用于更高要求的情况下的功能最齐全的版本。
插管的一个重要要素是加固件，当插管进入血管时加固件可使插管保持笔直的形状。移除加固件则使插管回到位于气囊下方的部分加强部弯曲成约90度的状态。
附图说明
附图所示的实施方案示出了本发明的主题，其中：
图1示出具有一个加强部的插管的视图，示出截面AA、BB和CC；
图2a示出具有一个加强部的插管的纵向截面图；
图2b示出具有两个加强部的插管的纵向截面图；
图2c示出插管的弯曲部分的纵向截面图；
图3示出插管的圆端的立体图；
图4a和图4b示出具有导丝和管心针的插管的视图；
图5示出具有导丝和管心针的插管的圆端的纵向截面图；
图6示出具有一体式针头的圆端的纵向截面图；
图7示出一体式针头的纵向截面图；
图8示出一体式针头的视图。
具体实施方式
在图1所示的第一实施例中，插管是由塑料制成的挠性管1，具有三个纵向腔室：主腔室1a、第一侧腔室1a1和第二侧腔室1a2，并且在远端侧具有圆端2，在圆端2中有纵向孔4，以允许静脉血在插管1内自由流动。孔4均匀分布在圆端2的周围。作为选择方案，孔4可以在圆端的圆周上均匀分布成两行并且在两行间彼此同步移位。
在圆端2的后方具有柔软部m1，其近端以球囊6为界，然后是加强部，加强部的一段以约90°的角度弯曲。然后从加强部进入柔软部m2，其在近端侧终止为锥体3，将插管轻巧紧密地密封。在锥体3内部有为球囊6充注的端口5和关闭主腔室1的阀12。充注端口5连接到第一侧腔室1a1，填充流体通过第一侧腔室1a1到达球囊6。插管利用金属丝螺线管加强并在加强部中保持形状记忆。金属丝可以用条带或丝网代替。在将插管置入血管之前，将装有人体工学手柄13的加固件8通过锥体3引入第二侧腔室1a2，其迫使插管1呈直线形。在移除加固件8之后，插管呈现的形状与进入胸部的解剖结构和角度比例保持一致。锥体3可移除地连接到插管1，使得可以在适当的时候将其移除并允许进入端口5。
在图2所示的第二实施例中，插管1的加强部被柔软部m2分开，在柔软部m2上施加夹具。而锥体3位于加强部的近端。
插管的第一种用法是外科医生通过肋间间隙的切口进入腔静脉区域，圆端2通过静脉切口插入内腔，然后通过外科手术方法将其固定。下一步是从第二侧腔室1a2中移除加固件8。然后在胸壁上再做一个切口并将外科器械插入手术区域附近的胸部，再用器械夹住锥体3并通向胸壁上的经皮切口，然后将锥体3通过胸部的经皮切口推出体外，使得外科医生可以在患者体外使用具有锥端的软插管。接着移除锥体3，从而释放端口5，再用注射器将球囊6充满流体。对于插管的柔软部m2，插入夹具并将体外循环连接到插管末端。然后，移除夹具，使得血液在封闭的体外系统中循环。在手术结束时，在插管的柔软部上施加夹具，断开体外循环，从球囊6中移除流体，并且在执行所有手术操作之后，移除插管。
采用经典的Seldinger方法使用插管是将一根长的Seldinger针插入腔静脉并插入一根导丝。然后将柔丝形式的导丝11从插管的圆端2穿过销钉7，并允许插管沿导丝11插入静脉中。当圆端2成功置入静脉时，血液出现在插管中。在将插管的适当部分插入之后，通过锥体3移除管心针7和导丝11。在移除管心针7之后，血液进入插管。在此阶段之后，后续步骤与第一种方法相同。
插管的另一种用法是将插管插入血管腔中，而无需导丝或手术切口。为此目的，使用配备有一体式针头10的插管，所述一体式针头10安装在圆端2内，如图6所示。针头10由通道形式的锐部14和位于锐部内的圆部15组成，两个部分都是独立的弹簧16、17并连接到触发按钮18。圆部具有多个入口以允许血液迅速流入插管。利用一体式针头10以适当的角度穿刺静脉。在足够的力的作用下，使针头的圆部15在压力作用下藏在血管壁上。刺穿血管壁后，由于弹簧17的作用，针头圆部15伸展以固定锐部14的刀片。利用正确的迎角，针头10位于静脉腔内不会穿透两侧壁。血液流入插管后，按下圆端2处的触发按钮18，使针头10藏入圆端2内，这允许在将加固件8滑出第二侧腔室1a2时进一步安全地将插管插入适当的深度，实现符合解剖结构的插管弯曲。
移除销钉7后，手术步骤与第一和第二种方法相同。

Claims (9)

1.一种用于经皮微创腔静脉插管术的插管，所述插管为具有至少一个锥端或圆端(2)的塑料管，并配有至少一个流入开口，以允许血液进入其内部，其特征在于，插管(1)具有三个纵向腔室，包括主腔室(1a)、第一侧腔室(1a1)和第二侧腔室(1a2)；插管(1)还具有至少一个确保内径恒定的加强部，在其远端侧具有朝向末端逐渐变窄的圆端(2)，圆端(2)具有纵向孔(4)，纵向孔(4)的尺寸允许静脉血自由流动；插管(1)还具有球囊(6)，在其下方的插管(1)的部分加强部弯曲成约90°的角度α；插管(1)在近端侧终止为柔性锥体(3)，其将插管紧密密封，在锥体(3)内部具有关闭主腔室(1a)的阀(12)和连接第一侧腔室(1a1)的用于向球囊(6)充注的端口(5)，此外在第二侧腔室(1a2)内具有可移除的加固件(8)，其远端在最极端位置到达球囊(6)的底部，当加固件(8)的近端穿过锥体(3)引出时，插管(1)的加强部保持形状记忆；其中
所述插管还包括管心针(7)，管心针(7)从中心穿过插管(1)，并且管心针(7)的远端到达圆端(2)的出口，其近端穿过锥体(3)到达插管(1)的外部，其中管心针(7)的近端装有符合人体工程学的蝴蝶结形式的人体工学手柄(9)。
2.根据权利要求1所述的插管，其特征在于，所述孔(4)在圆端(2)处的长边与所述插管的轴线重合。
3.根据权利要求1或2所述的插管，其特征在于，所述孔(4)沿着所述圆端(2)的圆周均匀分布。
4.根据权利要求1或2所述的插管，其特征在于，所述孔(4)围绕所述圆端(2)的周边均匀分布成两行，并且在两行之间相互同步偏移。
5.根据权利要求1或2所述的插管，其特征在于，所述插管(1)利用金属丝螺线管加强。
6.根据权利要求1或2所述的插管，其特征在于，所述插管(1)利用金属带螺线管加强。
7.根据权利要求1或2所述的插管，其特征在于，所述插管(1)利用任意编织的金属丝网加强。
8.根据权利要求1所述的插管，其特征在于，在插管的圆端(2)内安装有两件式一体式针头(10)，其中针头(10)由通道形式的锐部(14)和位于锐部(14)内的圆部(15)组成，其中圆部(15)具有至少一个入口，并且所述锐部(14)和圆部(15)均配备有单独的弹簧(16、17)并连接至触发按钮(18)。
9.根据权利要求1所述的插管，其特征在于，所述锥体(3)可移除地连接到所述插管(1)。
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