CN104602753B - 用于医疗线路的流动系统 - Google Patents

用于医疗线路的流动系统 Download PDF

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CN104602753B
CN104602753B CN201380036989.5A CN201380036989A CN104602753B CN 104602753 B CN104602753 B CN 104602753B CN 201380036989 A CN201380036989 A CN 201380036989A CN 104602753 B CN104602753 B CN 104602753B
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tubulose adapter
barrier film
female luer
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G·古亚拉
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Boella Industry S P A
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621Extra-corporeal blood circuits
    • A61M1/367Circuit parts not covered by the preceding subgroups of group A61M1/3621
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22Valves or arrangement of valves
    • A61M39/26Valves closing automatically on disconnecting the line and opening on reconnection thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10Tube connectors; Tube couplings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22Valves or arrangement of valves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10Tube connectors; Tube couplings
    • A61M2039/1083Tube connectors; Tube couplings having a plurality of female connectors, e.g. Luer connectors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22Valves or arrangement of valves
    • A61M39/24Check- or non-return valves
    • A61M2039/2433Valve comprising a resilient or deformable element, e.g. flap valve, deformable disc
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22Valves or arrangement of valves
    • A61M39/24Check- or non-return valves
    • A61M2039/2433Valve comprising a resilient or deformable element, e.g. flap valve, deformable disc
    • A61M2039/2446Flexible disc
    • A61M2039/246Flexible disc being fixed along all or a part of its periphery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22Valves or arrangement of valves
    • A61M39/26Valves closing automatically on disconnecting the line and opening on reconnection thereof
    • A61M2039/261Valves closing automatically on disconnecting the line and opening on reconnection thereof where the fluid space within the valve is increasing upon disconnection

Abstract

一种用于医疗线路的流动系统,其包括流动部件(1),流动部件(1)具有用于主流体的主导管(2)以及至少一个侧面管状适配件(3),该侧面管状适配件(3)具有通过阀(8)与主导管(2)连通的母鲁尔接口锥(4),阀(8)包括横向隔膜(10),通常抵靠侧面管状适配件(3)的环形阀座(12)而保持流体密封接触,其能眵在将公鲁尔接口锥流体导引器(H)插入到侧面管状适配件(3)后离开该位置至打开位置。隔膜(10)预先布置以用于直接由导引器(H)推进到打开位置,以及侧面管状适配件(3)配置以使得在导引器(H)与隔膜(10)推力接触前与导引器(H)以流体密封的方式联接。

Description

用于医疗线路的流动系统
技术领域
本发明的主题是用于医疗线路的流动系统,特别地是用于血液透析的流动系统,该类型包括流动部件,其具有用于主要流体的主导管以及至少一个侧面管状适配件,该侧面管状适配件(tubular fitting)具有通过阀与主导管相连通的内凹/母(female)鲁尔接口锥。
背景技术
上述限定类型的流动部件从以本申请人名义提交的欧洲专利No.EP-B-1661599获知,其中所述阀是所谓的防虹吸阀,包括由弹性可变形材料制成的杯状元件的底壁构成的隔膜,其外围边缘通常抵靠侧面管状适配件的环形阀座而保持呈液密接触。如在也以本申请人名义提交的专利No.EP-B-1093828中同样描述的,该阀的密封边缘能够从对应环形阀座移开至打开位置,紧接着将外凸/公(male)鲁尔接口锥流体导引器插入到侧面管状适配件的母鲁尔接口锥内。因此它是所谓“鲁尔接口启动/激活”型双通阀,其打开是机械地控制的,而不是仅通过引入到侧面管状适配件内的流体的压力来控制。
机械启动通常借助于另外的部件在这种类型的阀的情形中获得。例如,从也是以本申请人名义提交的意大利专利No.IT-B-1291508,由于公鲁尔接口锥流体导引器插入到母鲁尔接口锥配件内获得的隔膜阀的打开是借助于辅助管状滑动件获得的,所述辅助管状滑动件在所述配件中轴向可动并且搁置抵靠阀的隔膜。阀的打开因此由于通过辅助滑动件施加在隔膜上的轴向推力获得,辅助滑动件继而由公鲁尔接口锥导引器移动。
类似的解决方案在文献No.US-5,565,938A中描述。
该布置,除了相对复杂之外,在公鲁尔接口锥导引器提供与管状适配件的母鲁尔接口锥的气密密封/真空密封(hermetic seal)前会带来阀被辅助滑动件打开的风险,随之而来的是流体污染和泄露的问题。
发明内容
本发明的目的是克服上述缺陷并提供用于权利要求1的前序特征部中(并通常对应于在已经引用的欧洲专利No.EP-B-1661599中所描述和示意的)所限定类型的医疗线路的流动系统,其中流体导引器插入时阀的打开以精确且可靠的方式进行而不会有任何污染风险。
根据本发明,基于阀的隔膜被预先布置以用于由公鲁尔接口锥流体导引器推力的直接接触而被朝前述打开位置推进的事实,以及基于侧面管状适配件被配置成使得在前述导引器与前述隔膜成推力接触前所述导引器以流体密封方式联接的事实,该目的得以实现。
根据本发明的优选实施方式,侧面管状适配件由相对柔顺的弹性橡胶材料制成并且便利地是在前述流体导引器流体密封地联接至侧面管状适配件的母鲁尔接口锥时在径向方向上可弹性地延伸的。
侧面管状适配件的径向延伸可以通过想象到其侧壁是轴向地局部变薄的而便利地获得。
附图说明
本发明现在将参照附图进行详细地描述,所述附图仅通过非限制性实例提供,其中:
图1是根据本发明的用于医疗线路的流动系统的示意透视图;
图2是图1的系统的更大比例的顶部平面图;
图3是根据图2的线III-III的纵向截面图;
图4是根据图3的线IV-IV的截面图;
图5是流动部件的防虹吸阀的打开/关闭元件的透视图;
图6是流动部件的侧面管状适配件的立面的视图;以及
图7是根据图6的线VII-VII的轴向剖面图。
具体实施方式
在附图中表示的根据本发明的流动系统可以特别地应用于医疗血液透析线路。
该流动系统基本上包括流动部件1,其具有主管路2,设计用于在由箭头A所指示的方向上被主流体的流动所横穿,以及侧面管状适配件3,其在与导管2垂直的方向上延伸,用于将次级流体引入导管2内。
侧面管状适配件3被成形为像母鲁尔接口锁连接器,其鲁尔接口锥内表面由4所指示,以及其内端具有环形凸缘5,所述环形凸缘以流体密封/不漏液方式固定在从主导管2在横向凸出的环形轴环6处。
限定在环形凸缘5和环形轴环6之间的是用于双通阀的腔室7,其一般构造从已经引用的欧洲专利No.EP-B-1093828和No.EP-B-1661599获知。具体地,以及也在图5中更加清楚可见的,该阀包括元件8,其成形为像倒置的茶杯,由例如硅树脂的弹性材料制成,元件8的侧壁9搁置/倚靠在腔室7的底侧上,并且元件8的底壁,由10指示,限定了弹性可变形横向隔膜,元件8的外围边缘11通常设置为抵靠环形阀座12以与侧面管状适配件3的环形凸缘5内侧形成的锥形表面成气密接触。该气密接触基于由隔膜10上的杯状元件8的侧壁9所施加的轴向推力获得。
隔膜10与轴向突出13(在所示意实例中,数量为4个)的环一起形成,轴向突出13的环径向地朝向侧面管状适配件3的母鲁尔接口锥4的底部并且其功能将在下面阐明。
侧面管状适配件3有利地具有两个特有特征:首先,它由相对柔顺的/屈服性的、即顺应性的弹性材料(例如,聚对苯二甲酸丁二酯及其类似物)制成,并且优选地它的侧壁是轴向地局部变薄的,例如,以图7中所表示的方式,其中两个直径相反的部分14相比于较厚的其余部分15更薄。
其次,获得了母鲁尔接口锥内表面4,其以最小公差可能与图3和4中由虚线局部示意表示、并由H指示的常用公鲁尔接口锥流体导引器的尺寸相称/成比例。
这些特征致力于实现下文中将讨论的功能效果。
在所示意实例的情形中,主导管2在轴向与腔室8对应的区域中具有部位16,其具有内壁,该内壁具有收敛-发散廓线。该廓线由部位16的内壁的局部缩小的圆形17限定,在其上游(关于主流体的流动方向A)限定了收敛部,通过第一径向通道18与腔室7相连通,并且在其下游限定了发散部,继而通过第二径向通道19与腔室7相连通。尽管该构造关于阀的操作不是严格必需的,该构造对应于已经引用的专利No.EP-B-1661599中所描述和示意的一个,其功能效果将在下文描述。
在操作中,如前面所解释的,由杯形元件8限定的阀通常设定于闭合位置,其中隔膜10的外围边缘11由于侧壁9所施加的轴向推力,抵靠着环形阀座12而保持成流体密封的/不漏液的接触。
为了将第二流体引入主导管2中(或为了将流体从主导管2提取出),公鲁尔接口锥导引器H轴向地引入到侧面管状适配件4内并被推进到其中。考虑到参照上述的最小公差,在距离隔膜10的轴向凸出13一定距离处、即大约在图3和4中所表示的区域中,已经获得介于导引器H的公鲁尔接口锥与侧面管状适配件3的母鲁尔接口锥4之间的气密密封。导引器H的进一步轴向前进,其可能由参照上述的侧面管状适配件3的径向柔顺性的和可能局部变薄构造做出,克服由侧壁9施加的推力作用,产生了它与隔膜10的轴向凸出13的交互以及隔膜10的外围边缘11与阀座12的分离。这样,允许次级流体从导引器H流入腔室7中并因此进入主导管2内,或反之亦然。在该步骤中,具有收敛-发散廓线16的截面限定了文丘里管,其被设计以防止腔室7内次级流体的停滞。基于由发散廓线的区域中主流体的前述流动而获得的喷射效果,主流体的流动部分通过第一通道18穿透进入腔室7中并穿过第二通道19从其中出来。这样,主导管2内的主流体不仅实现了排空腔室7的效果,还实现了继续冲刷腔室7的有效作用。
当导引器H从侧面管状适配件3移出后,侧面管状适配件3再次恢复到其未变形状况,并且杯形元件8的侧壁9将隔膜10恢复到闭合位置,将外围边缘11再次推进到与环形阀座12成流体密封接触。
当然,在不由此偏离由所附权利要求书限定的本发明范围的情况下,可以相对于本文已描述和示意的内容对构造细节和各实施方式进行广泛地变化。

Claims (5)

1.一种用于医疗线路的流动系统,其包括:
流动部件(1),所述流动部件(1)具有用于主流体的主导管(2)以及至少一个侧面管状适配件(3),该侧面管状适配件(3)具有通过阀与主导管(2)相连通的母鲁尔接口锥(4),所述阀包括由杯形元件(8)的底壁构成的横向隔膜(10),杯形元件(8)由弹性可变形材料制成,杯形元件(8)的外围边缘(11)抵靠所述侧面管状适配件(3)的环形阀座(12)而保持成流体密封接触;以及次级流体的公鲁尔接口锥导引器(H),其能够利用母鲁尔接口锥(4)插入到所述侧面管状适配件(3)内以将所述横向隔膜(10)位移至打开位置,所述流动系统特征在于:所述隔膜(10)预先布置以用于由所述导引器(H)的直接推力接触而推进到所述打开位置内,以及所述侧面管状适配件(3)配置成使得在所述导引器(H)与所述隔膜(10)成推力接触之前与导引器(H)以流体密封的方式联接;
其中,所述侧面管状适配件(3)由相对柔顺性的弹性材料制成并且能够在与所述导引器(H)成流体密封联接时在径向方向上弹性地延伸;
所述侧面管状适配件的侧壁具有比所述侧壁的剩余部分更薄的两个直径相对的轴向部分; 和
其中所述隔膜形成有径向面向所述母鲁尔接口锥的基部的轴向突出环,使得所述导引器与所述轴向突出环的接触允许从所述导引器到所述主导管的流动。
2.根据权利要求1所述的流动系统,其特征在于,所述侧面管状适配件(3)具有沿轴向局部变薄的壁(15)。
3.根据权利要求1或2所述的流动系统,其特征在于,所述隔膜(10)具有轴向凸出(13)的环,其径向地朝向所述母鲁尔接口锥(4)。
4.根据权利要求3所述的流动系统,其特征在于,所述隔膜(10)的外围边缘(11)在由所述杯形元件(8)的侧壁(9)施加的轴向推力作用下抵靠所述环形阀座(12)保持成流体密封接触;在使用中在所述导引器(H)与所述轴向凸出(13)之间的交互时所产生的所述隔膜(10)的变形引起所述外围边缘(11)的径向收缩以及其随后从所述环形阀座(12)的分离。
5.根据权利要求1或2所述的流动系统,其特征在于,所述主导管(2)在对应于所述杯形元件(8)的位置中具有轴向剖面(16,17),其具有收敛-发散廓线。
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AU2013288398A1 (en) 2015-01-29
WO2014009823A1 (en) 2014-01-16
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