CN1042661A - 止血阀 - Google Patents
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Abstract
一种插管器护套组合件,有改进的阀组合件,其中有至少三个弹性圆盘形膜。第一膜有一中心圆孔,密封装入的导管,第二膜有中心孔小于第一膜的孔,密封装入的引导钢丝。第二膜还至少有一条从孔上通过的开缝,供较粗的导管通过。第三膜有至少一条通过中心的开缝,在没有引导钢丝和导管时将阀组合件密封。
Description
本发明一般地涉及止血阀,具体地涉及用于将通入血管内的导管定位与操作的止血阀。
在血管造影术及心导管插入术中,使用插管护套组合件,形成通入血管内腔的通道属于已知技术,通过该通道可将导管插入或取出,而不致血液流失。插管护套组合件典型有一个有阀件的主体、主体与一个柔性插管连接或伸入柔性插管中,通常用针、引导钢丝或扩张器将柔性插管插入血管插管中。参阅美国专利第4,000,739号。阀件的设计为在将导管放入时,可围绕导管密封,而将导管取出时,将插管护套组合件内的通道密封。
当前采用的许多方法中,必须使用一个以上的导管,并用一导管替换原已放入血管的另一导管。在操作中,当引导钢丝仍留在血管中时,将体内的导管沿引导钢丝上取出。引导钢丝通过插管器插管及插管器阀组件留在体内。将新导管沿原有的引导钢丝,通过插管器插入人体。
当阀中有一个有容纳导管,并和导管密封的孔的弹性膜时,在取出第一导管后而在插入第二导管前,引导钢丝留在原位置上,由于钢丝直径小于导管,常发生血液通过插管器阀泄漏。当然这是不利的。
现在使用的其他种将导管密封的阀,膜上不用孔,可适合一个系列的导管与钢丝的直径,但这类设计常造成操作中的钢丝或导管外部较高的摩擦力,增加医生的困难。
因此有要求提出一种阀,无论在有导管时,或只剩下钢丝时,或在钢丝及导管都存在时,都可提供良好密封,使用时导管或钢丝都比较容易操作。
本发明提出一种改进的止血阀,至少有三个弹性膜或圆盘形衬垫。第一个弹性膜上布置一个圆孔,第二个弹性膜上有一个直径比第一膜的孔孔径小的孔。第二膜还有至少一个与孔相交的开缝。第三个膜有开缝而无孔。在理想实施方案中,开缝为直线形,并在护套存在的开缝,相互交叉,最好为90度。开缝可有某些其他形状,例如Y形,使导管或钢丝易于从膜中通过。设有装置将第二膜与第三膜在阀中对正,而使它们交叉的开缝定向。
在阀的另一实施方案中,将一个有中心孔的垫圈放在第二及第三膜之间。孔周为圆锥形,并在使用导管时,圆锥孔与第二膜的开缝张开的远端对正。
阀还有一个连接装置,容纳安置在连接装置的进口端到出口端间的通道中的弹性膜。在一个方案中,进口端到出口端与其他器件,诸如扩张器、防脓毒装置、插管等作可拆卸的连接。作为举例将一个扩张器与进口端作稳定连接,便利将一个护套插入血管腔内。一旦撤去扩张器,便可将导管或钢丝,通过阀端护套,向血管中插入或撤出,而基本不泄漏血液。此外,进口端可形成一个不连接的帽,帽上有一个通孔,容纳导管及钢丝,并可将一个柔性插管在连接装置的出口端上永久固定。
在连接装置的一个实施方案中,有一个带进口端的帽部,和一个带出口端的主体部。将帽部与主体部安装时,膜周缘在二者间被压紧,迫使第三膜的开缝离开第二膜远伸而不张开。
将第二及第三膜对正,使其直线开缝交叉这一点可通过在第二及第三膜上各设突出部或凹入部,开缝交叉时第二膜上的突出部与第三膜上的突出部对正。连接装置上设凹部,将上述突出部纳入其中。
图1为本发明止血阀一个实施例的局部已拆卸的立体图;
图2为图1实施例的有导管插入止血阀的放大剖视图;
图3为图1实施例的有引导钢丝插入止血阀的放大剖视图;
图4为用于插管护套组合件的止血阀侧视放大剖视图;
图5为止血阀弹性膜另一实施例已拆卸的立体图;
图6为止血阀弹性膜第二实施例已拆卸的立体图;
图7为图1中止血阀第二实施例剖面的立体图;
图8为有引导钢丝的图7止血阀侧视放大剖视图;
图9为有导管的图7止血阀侧视放大剖视图;
图10为止血阀第三实施例的局部已拆卸的立体图;
参看图1至3,一个用标号10的总的标示的止血阀,有一个连接器,有带出口端14的主体12,并有与主体12连接的有进口端20的帽16。连接器的形式为有一个大致圆柱形的空心内部,形成从帽16进口端20、沿连接器轴线通向出口端14的、用箭头22标示的通道。连接器包括帽和主体,用若干熟知的适当塑料之一制造,例如用高密度的聚乙烯,或者如理想实施例中使用的ABS,较为便利。
止血阀还有若干弹性膜,总的用号30标示,放在连接器中,更具体地说至少有三个弹性膜32,34及36。
每一膜最好为环形,用乳胶,硅橡胶,或其他适当的密封材料制造。弹性膜32有孔38位于膜的中心。孔38的直径略小于用于阀中的导管的直径。弹性膜34中心有孔40,直径略小于用于导管的引导钢丝的直径。弹性膜34的孔40比膜32的孔38小很多,安装在阀中时与孔38同心。膜34也有一个开缝42,最好是与孔40交叉的直线形,在孔的直径上向两侧伸展。
环形弹性膜36有开缝44,最好是直线形,在膜的中心上通过。最好在放入连接器中时,使开缝42及44互相垂直,但并非必须。开缝42及44最好为直线形,但也可用Y形开缝45及46,或一对十字形开缝49及47,分别如图5及6所示。
帽16的近端有一个内穴62,形状如路厄氏注射器中的外筒,或改进型外筒形式。帽16在其外管端部上,形成有内环形凹槽的突出部64,该突出部64与通道22垂直。帽16的终端有一圆柱形壁66,从突出部64沿通道22方向延伸至终端,终端端面有环形表面65,还有环形凹表面67。
与帽16配合的主体12的端部大致为圆柱形,有内穴68。主体12的圆柱形壁70,有近端表面用以与帽16连接,该端面有一个凹入环形表面71和一个伸出的环形表面72,用以分别与帽16上的伸出及凹入的表面65及67插接。壁70有一个内环形端面74,最接近地伸出表面65及67。帽16可按扣安装,焊接或粘合,与主体12连接。相连时,壁70的环形内端面74及有内环形凹槽的突出部64,将环形弹性膜32,34及36的边缘部保持夹持,将其约束在帽16中。圆盘形膜垂直于通道22放置,其中心基本于与帽及主体形成的连接器同纵向轴线。一个环形棱脊76在突出部64上形成,弹性膜32与之接触,将膜与帽之间密封。与之相似,表面74上有环形棱脊77,膜36与之接触,将膜与主体12密封。
主体12的远端80也是圆柱形,形式为路厄注射器的柱塞,用以接受一个有路厄注射器外管构适的柔性插管,使主体的内部及通道22与柔性插管内部液体连通。
圆柱形伸长部82与主体12一体形成,从主体上侧向伸出,有通道84与通道22接通。这通道可用于将肝素化盐水之类的液体,引入止血阀。在阀10的全部使用过程中保持液体的正压力,防血液从延伸部82中流出。
阀10应用方式之一,例如,包括将一个直径基本与导管相同的空心塑料扩张器(未示),与帽16连接,扩张器位于通道22内,伸出与连接器主体12的远端连接的柔性管的端部之外。运转时,将有一个带套针的空心针穿过血管,再将套除去。用一个引导钢丝代替套针,将针取出,并在患者皮肤上作切口。将附有阀10的扩张器套在引导钢丝上插入,直至扩张器锥形端进入血管腔内。然后将附在阀10上的柔性插管,套在扩张器上插入血管内。将钢丝与扩张器取出,将阀与护套用胶布或缝线在患者身体上固定。一旦取去扩张器及引导钢丝,膜36的开缝合拢,将通道22密封。拱起的膜36(例如图4中可见)可抵制患者血压施加的力,防止血液流失。现将导管通过膜32上的孔38伸入,通过膜34及36上的开缝,最后进入血管腔内。如果需要取出导管,并用引导钢丝52插入一个新导管,如在冠状血管成形术的导管更换,在没有导管时膜34可将引导钢丝密封。
将导管50插入通道22中时,弹性膜32将导管围绕孔38密封,如图2所示。膜34及36的开缝42及44分别张开,使导管基本无阻碍从膜中通过。撤出导管50时,膜36上的开缝44关闭,将孔38及40密封,防止血液通过通道22回流。
当将引导钢丝52插入通道22而无导管50时,弹性膜34围绕孔40与钢丝密封,如图3所示。膜32不造成障碍,因为孔38大于钢丝52,膜36的开缝48使引导钢丝52可基本无障碍通过膜36。假如没有膜34,撤去导管50而将钢丝留下时,血液便将通过通道及孔38反向泄漏。
由于膜34及36的开缝42及44分别互相交叉,最好是90°交叉,故倾向于将导管或引导钢丝在阀中定中。由于膜34及36各仅有一条直线开缝,故倾向于抑制患者的反向血压阻止血液漏过。尤其在膜36拱起时是如此。
参看图10,为使膜34及36的开缝对正,膜34在周缘上有两个突耳96及97,而膜36有突耳98及99。突耳在各膜上间隔90°,膜34的一对突耳96、97,与膜36上的一对突耳98,99对正。
图中膜32也有突耳101及103,与膜34上的突耳96,97对正,但膜32不必需有突耳。帽的圆柱形内壁上形成相应的凹槽容纳弹性膜的突耳。图10仅示帽的四分之一部分,显示帽的内部有凹槽108及110的部分。也可用其他措施使膜对正,例如在膜上形成凹槽,而在帽上铸成突出部或形成凹口等等。例如,为作说明,在帽16圆柱形壁66的内表面上有突出部150。膜32、34及36上分别有凹陷152,154及156,在阀中组装时容纳突出部。
虽然上面叙述将开缝互相交叉,但并非必须。可将其对齐而阀组合件仍运转正常。
现参看图4,用号10′表示整体的阀,图示有一个连接器,连接器有带出口端14′的主体12′,一个帽16′与主体12′连接。除远端外,主体12′与主体12相同。可使主体12′有一个锥形部分100,围绕柔性插管102的一段,以代替与主体12一体形成的路厄注射器的柱塞。帽16′也与帽16相似,唯其近端部分例外。连接部的帽16′可有一个端壁104,上有孔106穿过,以代替路厄注射器的凹形结构。阀10′有图1-3中的膜30。图4中的组合件形成作为止血阀的插管护套组合件。
为保证环形棱脊76与膜之间,环形棱脊77与膜之间,有良好的密封,各膜间以很大的压力压紧。这样便将外端膜32及36,从中间膜34向外拱起。参看图2及3,示近处的膜32拱起,图4示远处的膜拱起。拱起不致使开缝完全张开,但凹入的拱形能抵制血管的任何反向压力,该压力将血液通过通道22压回。反压越高,开缝越倾向于关闭。图示的全部实施方案中,膜36都发生拱起。
图7显示另一实例的插管护套组合件,其中有主体12,帽16′,与阀组合件的膜32,34及36。还有一个垫圈120,放在膜34及膜36之间,膜36处在膜34与垫圈120的远端。垫圈120有一个大的中心孔122。在最佳实例中,孔122为圆锥形,其大孔端在邻近膜34的一侧。如图9所示,当有导管穿过膜34的小孔与开缝时,将一部分膜材料向着远外的膜36推送。垫圈120的圆锥形孔122提供容纳被移动的膜34的材料,从而不与膜36接触,以避免对导管50在组合件中往返活动时,造成任何不利的干扰,或加大阻力或增加摩擦力。可参照图2进行比较。
虽然对本发明已对其最佳实例进行介绍,然而应理解还可有其他方案,符合权利要求书界定的发明的精神与范围。
Claims (24)
1、在一种止血阀中,其特征在于,其包括下列各项:
一个第一弹性膜,膜上有一个圆孔;
一个第二弹性膜,膜上有一个圆孔,直径小于该第一弹性膜上的该圆孔,该第二弹性膜另至少有一个开缝与该较小圆孔相交;
一个第三弹性膜,膜上无孔,而有至少一个开缝。
2、根据权利要求1所述的止血阀,其特征在于,该第一及第二弹性膜基本同心。
3、根据权利要求2所述的止血阀,其特征在于,该第二弹性膜上的该至少一个开缝有在第一方向上的基本直线形,该第三弹性膜上的该至少一个开缝有在第一方向的横向上的基本直线形,同时该两开缝与该第一及第二膜上的共同轴线相交。
4、根据权利要求3所述的止血阀,其特征在于,该第二及第三弹性膜上的该开缝基本互相垂直。
5、根据要求3所述的止血阀,其特征在于,该阀有装置将该第二及第三弹性膜,在该组合件中对正,从而使该两开缝互相垂直。
6、根据权利要求5所述的止血阋,其特征在于,该膜为圆形,该对正装置包括各在该第二及第三膜上的一对间隔的突耳,该第二膜上的该对突耳与该第三膜上的该对突耳对正。
7、根据权利要求1所述的止血阀,其特征在于,该阀还有一个垫圈,邻近第二及第三膜安置,而位于二者之间,该垫圈上面有孔,大于该第二膜的孔,并在该第二膜的孔上叠置。
8、根据权利要求7所述的止血阀,其特征在于,该垫圈的该孔的周缘为圆锥形,当该阀组合件中有导管时,便利于该第二膜的该一个开缝向远端分开。
9、一种止血阀,其特征在于,包括下列各项:
一连接器装置,有一个进口端,一个相对的出口端,和一条在该进口端及该出口端之间,穿过该阀伸展的通道;
若干弹性膜安装在该通道内,该若干膜包括:
一个有一个圆孔的第一弹性膜;
一个第二弹性膜,有圆孔,直经小于该第一弹性膜的该圆孔,该第二弹性膜另有至少一条开缝,与该较小圆孔相交;
一个至少有一条开缝的第三弹性膜。
10、根据权利要求9所述的止血阀,其特征在于,该第一及第二弹性膜的孔基本同心。
11、根据权利要求10所述的止血阀,其特征在于,该第二弹性膜的该至少一条开缝,在第一方向上是基本直线形,该第三弹性膜的该至少一条开缝,在该第一条直线形开缝的横向上,也是基本直线形状,该两开缝都与该第二及第三膜的共同同轴中心线相交。
12、根据权利要求11所述的止血阀,其特征在于,该第二及第三弹性膜的开缝基本相互垂直。
13、根据权利要求11所述的止血阀,其特征在于,该阀有装置,将该第二及第三弹性膜,在该组合件中定向,从而使该两开缝互相横向交叉。
14、根据权利要求9所述的止血阀,其特征在于,该连接器装置有一个第二进口,与该通道是液体连通。
15、根据权利要求9所述的止血阀,其特征在于,该进口端有一个连接器装置,用以将该阀和一个分别的医疗器械可拆卸的连接。
16、根据权利要求15所述的止血阀,其特征在于,该连接器装置有一路厄式的凹入连接件。
17、根据权利要求9所述的止血阀,其特征在于,该出口端有一个连接器装置,将该阀与一个护套插管组合件作可拆卸的连接。
18、根据权利要求17所述的止血阀,其特征在于,该连接器装置有一个路厄式的凸出连接件。
19、根据权利要求9所述的止血阀,其特征在于,该阀有一个柔性插管,与该出口端是液体连通。
20、根据权利要求9所述的止血阀,其特征在于,该连接器装置有一个帽部,帽部有一个进口端,与有该出口端的主体部连接,该帽部与主体部用于当将该帽部与该主体部连接时,将该第一、第二及第三弹性膜的周缘部压紧在一起,该第三弹性膜的中心部有开缝,由于上述的压紧而被移动离开该第二弹性膜,但该开缝仍不张开。
21、根据权利要求9所述的止血阀,其特征在于,该第二及第三膜的该至少一条开缝为Y形开缝。
22、根据权利要求9所述的止血阀,其特征在于,该第二膜的该至少一条开缝,包括一对开缝,相互横向交叉,并与该孔相交。
23、根据权利要求22所述的止血阀,其特征在于,该第三膜的该至少一条开缝,包括一对互相交叉的开缝。
24、根据权利要求13所述的止血阀,其特征在于,该膜为圆形,该定向装置为各在该第二及第三膜上的一对间隔的突耳,该第二膜上的该对突耳与该第三膜上的该对突耳对正;该连接器装置有一条内凹槽容纳该突耳。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US07/273,282 US5000745A (en) | 1988-11-18 | 1988-11-18 | Hemostatis valve |
US273,282 | 1988-11-18 |
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CN1042661A true CN1042661A (zh) | 1990-06-06 |
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ID=23043292
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Application Number | Title | Priority Date | Filing Date |
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CN89108695.1A Pending CN1042661A (zh) | 1988-11-18 | 1989-11-18 | 止血阀 |
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EP (1) | EP0369314A3 (zh) |
JP (1) | JPH02189163A (zh) |
CN (1) | CN1042661A (zh) |
AU (1) | AU4536889A (zh) |
CA (1) | CA2001558A1 (zh) |
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CN100471535C (zh) * | 1998-05-29 | 2009-03-25 | 劳伦斯A·林恩 | 路厄氏接纳器与输液的方法 |
CN104284621A (zh) * | 2012-02-29 | 2015-01-14 | 加图立大学校产学协力团 | 用于结肠镜检查的辅助工具 |
CN105209105A (zh) * | 2013-03-15 | 2015-12-30 | 波顿医疗公司 | 止血阀和输送系统 |
CN105209105B (zh) * | 2013-03-15 | 2019-01-04 | 波顿医疗公司 | 止血阀和输送系统 |
CN110075418A (zh) * | 2013-03-15 | 2019-08-02 | 波顿医疗公司 | 止血阀和输送系统 |
CN110075418B (zh) * | 2013-03-15 | 2021-12-10 | 波顿医疗公司 | 止血阀和输送系统 |
CN103736195A (zh) * | 2014-01-13 | 2014-04-23 | 厦门鑫康顺医疗科技有限公司 | 一种无菌导管鞘 |
CN103751900A (zh) * | 2014-01-13 | 2014-04-30 | 厦门鑫康顺医疗科技有限公司 | 一种无菌导管鞘 |
CN103736195B (zh) * | 2014-01-13 | 2018-07-03 | 厦门鑫康顺医疗科技有限公司 | 一种无菌导管鞘 |
CN114377248A (zh) * | 2017-06-08 | 2022-04-22 | 贝克顿·迪金森公司 | 隔膜固定 |
Also Published As
Publication number | Publication date |
---|---|
JPH02189163A (ja) | 1990-07-25 |
DK579389A (da) | 1990-05-19 |
CA2001558A1 (en) | 1990-05-18 |
NO894586D0 (no) | 1989-11-17 |
NO894586L (no) | 1990-05-21 |
US5000745A (en) | 1991-03-19 |
FI895365A0 (fi) | 1989-11-10 |
EP0369314A2 (en) | 1990-05-23 |
DK579389D0 (da) | 1989-11-17 |
EP0369314A3 (en) | 1990-09-05 |
AU4536889A (en) | 1990-05-24 |
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