CN1077654A - 医用阀及其使用方法 - Google Patents

医用阀及其使用方法 Download PDF

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CN1077654A
CN1077654A CN92115237A CN92115237A CN1077654A CN 1077654 A CN1077654 A CN 1077654A CN 92115237 A CN92115237 A CN 92115237A CN 92115237 A CN92115237 A CN 92115237A CN 1077654 A CN1077654 A CN 1077654A
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C·A·洛佩斯
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ICU Medical Inc
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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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • 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
    • A61M39/02Access sites
    • A61M39/04Access sites having pierceable self-sealing members
    • A61M39/045Access sites having pierceable self-sealing members pre-slit to be pierced by blunt instrument
    • 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
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F21LIGHTING
    • F21KNON-ELECTRIC LIGHT SOURCES USING LUMINESCENCE; LIGHT SOURCES USING ELECTROCHEMILUMINESCENCE; LIGHT SOURCES USING CHARGES OF COMBUSTIBLE MATERIAL; LIGHT SOURCES USING SEMICONDUCTOR DEVICES AS LIGHT-GENERATING ELEMENTS; LIGHT SOURCES NOT OTHERWISE PROVIDED FOR
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J2200/00General characteristics or adaptations
    • A61J2200/10Coring prevention means, e.g. for plug or septum piecing members
    • 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
    • A61M2039/262Valves closing automatically on disconnecting the line and opening on reconnection thereof having a fluid space within the valve remaining the same upon connection and disconnection, i.e. neutral-drawback valve
    • 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
    • A61M2039/267Valves closing automatically on disconnecting the line and opening on reconnection thereof having a sealing sleeve around a tubular or solid stem portion of the connector
    • 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/32General characteristics of the apparatus with radio-opaque indicia
    • 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/58Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583Means for facilitating use, e.g. by people with impaired vision by visual feedback
    • 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/60General characteristics of the apparatus with identification means
    • A61M2205/6063Optical identification systems
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S604/00Surgery
    • Y10S604/905Aseptic connectors or couplings, e.g. frangible, piercable

Abstract

一种密闭的无针阀装置包括一个通常的管状壳 体,该壳体限定一个内腔。在该壳体的近端有一个开 口,它最好足够大以容纳一个医疗器械的一个ANSI 标准端。该壳体的远端具有一个通常的管状裙缘。 该阀也包括一个中空的尖钉,该尖钉有一个被封闭的 尖端,该尖钉至少包括一个设置在尖端末梢的纵向 18个标准尺寸的孔,并且该尖钉安置在该腔内以使 得该尖端位于壳体的近端之下。一个环形支撑套箍 与该尖钉相连接,它密封该壳体腔的一部分以形成包 含该尖端的一个上腔。

Description

本发明涉及一种密闭的将介质输入病人体内的系统,它采用一个无需任何中间针、盖或接合器的直接与该系统连接的标准医疗器械,能使系统在投药之后自动地重新密封。使用了一个消除死区的二通阀,它包括一个密封件,当受到该医疗器械的压缩时,该密封件被刺穿而打开阀,并且当减压时该密封件重新密封,甚至在高压和重复使用之后仍能保持流体密封(fluid  tight  seal)。
在医院中用于肠胃外投药的流体操作和医疗安装经常包括连接器和接合器的使用,以便于流体在两点之间的流动。大多数流体连接器和接合器使用针来刺穿覆盖无菌管的隔膜或刺穿一个流体药物容器的隔膜,然后流体从容器或装满流体的管中流入一个注射器或第二个管中。这些连接器和接合器通常具有机械的或活动的部分。由于穿过连接器和接合器的流体现成通道对病人的生存通常是关键的,因此可靠地及可重复地操作连接器和接合器是绝对必要的,接合器和连接器在使用期间的故障可能会对病人的生命构成威胁。机械的或活动的部分(例如弹簧和膜片)越多,它们误动作的可能性就越大。误动作会导致把气栓塞引入到病人体内,因此机械部分越少,这些连接器的可靠性就越高并且它们就将更好地为医学界所接受。
许多连接器或阀,尤其是那些使用了几个机械部件的连接器或阀,在其内部具有一个相当高容积的流体空隙。在装置内的这个“死区”妨碍了精确流体容积的准确导入并且为装置的分离而造成污染提供了机会。连接器和接合器通常包括允许或切断流体沿着流体移动路径流动的阀。那些通常使用的几种连接器采用金属针来刺穿无菌密封件。这些连接器通常被设计成在一个方向上蓄积流体的流动。这意味着流体管线上必须有连接器和在互补方向上直线对准的管。这些连接器通常需要进一步的操作,例如如果阀无意中被安装在一个不便于流体流动的方向上时。这些操作增加了对连接器的处理,因此即增加了污染的危险也增加了建立流体连接所需的时间。
作为连接器装置一部分的金属针增加了刺伤使用者的危险性。在这些装置中使用的针通常具有设置在针尖端的通孔,阀与一个流体管线的连接包括针刺穿一个密封的隔膜。设置在针尖端的通孔可以装入隔膜材料并使自由细粒进入流动管线中。可以证明这种情形对病人来说是致命的。这样的通孔也很容易被隔膜材料堵塞。
由于必须经常地给连接于一个病人的流体管线增加部件或取下部件,因此对医疗应用来说可重复使用的连接器和接合器是优选的。但是,可重复使用的连接器难以保持无菌。有时使用盖子来覆盖连接器以保持其无菌。但这些盖子经常被丢失,或者因为需要时不容易得到它们而无法简单使用。
一种容易使用并只采用一个与病人连接的阀装置(该阀装置无需被覆盖或通过一个针或接合器与医疗器械相互连接)的、可擦洗的、具有足够的耐久性以致在几次操作后仍可保持其功能、并在高压下保持流体密封的将介质输入病人体内的密闭系统,将给医学界带来巨大的利益。
本发明的阀具有几个特征,但没有任何一个特征可以单独构成其期望的特性。在不限制由随后的权利要求书所表达的本发明范围的情况下,现在将简短地讨论更突出的特征。在考虑了这一讨论之后,尤其是在阅读了题为“优选实施例的详细描述”的段落之后,人们将会理解本发明的特征是怎样提供了这些优点,这包括安全、可靠和可重复使用、消除了死区、操作和使用简单、以及利用了一种在使用后可擦洗的以保持其无菌并在高压下具有流体密封的阀。
本发明提供了一种密闭的将介质输入病人体内的系统,它采用一个无需任何中间针、盖或接合器的直接与该系统连接的医疗器械,能使系统在投药之后自动地重新密封。使用了一个利用可重复使用的密封件的二通阀,该密封件可以被一个封闭的、安全的、非金属尖钉(而不是一个暴露的金属针)可重复地刺穿。该阀便于输送流体,尤其是液体,同时保持其无菌。该阀易于使用并且能够固定就位。在使用之后,该阀可以用一种适当的物质按常规方式进行擦洗以保持无菌。该阀的设计避免了意外的针堵塞。正如将在下面讨论的那样,作为一个能使液体从一个密封的容器中流出的医用连接器或接合器,该阀是有用的。
本发明的第一个特征在于该阀具有一个壳体,该壳体包括限定一个内腔的壁结构,该内腔具有一个近端和一个远端。该腔具有一个开口空隙,密封件可以推入该空隙内,并且该腔最好具有在壁结构中靠近密封件的多个径向凹槽,以容纳受压缩而产生的密封件的伸胀。内腔的近端具有一个足够大的开口以容纳一个医疗器械的输送端,该医疗器械通过该输送端将流体输出。在大多数应用中,医疗器械的输送端是锥形的,并且靠近开口的壁结构是向内锥形的,因而当该输送端插入该开口时该壁结构与该锥形输送端相互紧密配合。该腔的近端最好适于与一个医疗器械的ANSI(美国国家标准学会)的标准端紧密配合。该器械一般可以是一个注射器、一个连接器或一个静脉注射(IV)装置的入口/出口、或在医疗应用中使用的各种导管中的任何一种。
本发明的第二个特征在于该尖钉具有一个尖端,该尖钉具有设置在该尖端或靠近该尖端的至少一个孔,以及一个与该孔连通的通道,它使得流体可以流经该孔。该尖钉安置在该腔的内部以使得该尖钉在该近端的内侧并被密封在该腔内。该孔最好位于靠近该尖端的尖钉的一侧且是细长形的,并具有18个标准尺寸(gauge)或更大。该尖端可以是尖锐的或稍圆形的。对于许多应用希望多于一个孔,并且三个对称地设置于该近端内侧的孔是最佳的。该尖钉可以包括至少一个肋,该肋允许空气进入该密封件与该尖钉之间的空隙,因而当移开器械时便于开口的密封。该尖钉可以具有一个基本上圆锥形的形状,并且该密封件具有一个互补的基本上圆锥形的腔,该腔的形状与该尖钉的形状相一致。该尖钉安置在这个圆锥形腔内并且该密封件覆盖该尖端。该尖端可以嵌入该密封件的近端或推入该圆锥形的腔内。该尖钉的尖端最好具有一个凹槽内接合的多个刻面。优选的尖钉应当能够重复地穿透该密封件而又不会刺破该密封件。尖端粗糙的边缘可能会产生刺破问题。在优选的塑料尖钉的注射成型过程中,尖端的多个刻面将沿着一条“接合线”邻接并能形成一个可刺破密封件的粗糙边缘。将该接合线埋入一个凹槽内可以避免这个问题。由于在这条接合线上的任何粗糙边缘都被埋在一个凹槽内,所以密封件在该凹槽上方移动并且不与粗糙边缘接触。
本发明的第三个特征在于弹性密封件,当医疗器械的端部插进该阀的开口时该弹性密封件变成压缩状态,并且当医疗器械的端部移出时该弹性密封件变成减压状态。该密封件在减压状态下具有一个基本上完全充满靠近开口处的该腔的一部分的一个段。该密封件段靠压在邻近开口的壁结构上以密封该开口。在压缩状态下医疗器械的输送端将该密封件段推离开口并进入腔内。当该密封件变成压缩状态时在该密封件段与避结构之间保持着流体密封。当该医疗器械的端部将该密封件推移进入腔内时该密封件段靠压在避结构上。并且最重要的是,该输送端与该密封件适合于相互接合,以使得当尖钉的尖端刺穿该密封件时在所说输送端与该密封件之间基本上不存在死区。因此,采用本发明,预定剂量的药物可以全部输入病人体内,而不会有任何规定剂量的药物聚积在阀的死区内。精确数量药物的输送在某些情况下是要求很高的,例如当准备投用化学药剂或治疗婴幼儿时。
在重复开启和关闭阀的过程中始终保持着流体密封,并且该密封件在其外表面具有一个凹入部分,它形成一个气陷以便于该密封件的移动。该密封件最好具有与该腔的近端基本上同高的表面。在一个实施例中,该密封件的近端基本上是平的,该密封件由一种具有30至70肖压硬度的材料(例如一种硅酮聚合物)制成。该密封件可以包括一个杯状凸缘用于在靠近该腔的近端处与壳体接合。密封件的一个优选实施例包括堆积在一起并相互连接形成一个单一结构的一连串O形环元件。这些O形环元件具有递增的直径,靠近该腔的近端元件的直径最小。可以预先切割密封件的近端以在其中形成一个细小的孔,当压缩该密封件时允许尖钉的尖端容易地穿过该细小的孔。该密封件的近端最好具有一个设置在该腔内的截头圆锥形状部分。该密封件也可以具有一个中心设置的、反压力的(anti-vacuum)、盘状的凹陷,它不妨碍当希望时对该密封件的露出近端进行擦洗的性能。
本发明的第四个特征在于壳体和尖钉是该阀的两个独立的部件,通过壳体与尖钉的装配和互锁它们牢固地互相连接。该壳体具有一个靠近该腔的远端的第一锁定件,而该尖钉具有一个第二锁定件,它适于在装配时与所说第一锁定件互锁。该密封件具有一个延伸超出该远端并位于该第一和第二锁定件之间的唇缘,以使得当装配时该唇缘被压缩在这两个锁定件之间并且当它们互锁时基本上形成一个流体密封。
本发明的第五个特征在于该医用阀包括一个连接于该尖钉的支座部件,它密封了该腔的远端。该支座部件可以具有一个Luer-Lock型连接器元件,它能使该阀可拆卸地连接于(例如连接于一个病人的)一个流体管线上。该支座部件也可以是一种接合器的形式,它能使该阀可拆卸地连接于一个流体分配器或容器上。当用于从一个容器分配流体时,尖钉具有一对相对的尖端,它们分别位于该尖钉的远端和近端。在该尖钉远端处的尖端刺穿密封容器的盖部件。接合器上的一个径向狭缝使之能够充分地可逆地变形以紧密地配合在该容器上。
本发明的第六个特征在于该密封件具有一个包括一个压敏元件的近端,该压敏元件设置在靠近开口处的该密封件的内表面上。当处于减压状态时该压敏元件在该密封件的近端封闭该密封件中的任何孔隙以基本上形成一个流体密封。甚至在有时医疗应用中遇到的(尤其是当阀连接于一个病人的动脉时)非常高的压力的情况下,该压敏元件能使该阀保持流体密封。本发明的阀甚至当阀内的压力高于6磅/英寸2(psi)时仍能保持密封,并且它能经受高于30磅/英寸2的压力。典型地,该压敏元件是具有入到一个预先切割的孔隙中的入口的密封件的一段。这个段具有一个基本上圆柱形的构造并被一个充满压缩流体的环形空隙所围绕,该部件和该环形空隙的中心与该孔隙的入口同轴。压缩流体充满该环形空隙以施加压力而压缩该圆柱形段,以紧密地封闭该孔隙的入口。该压敏元件最好具有一个防刺破元件。
根据本发明,可以从远距离药源将一个已知的、规定的、预定剂量的药物直接输送给病人,因此该预定剂量的药物基本上不会聚积在阀的死区内。换句话说所有规定剂量的药物全部被病人所接收而没有损失在阀中。因而,本发明也包括从一个远距离药源将流体输送给病人的方法。本发明也包括从病人将流体输送给远距离药源。这是可能的,因为本发明的阀具有二通性能。当流体经过器械时对流体施加压力可使流体输送给病人,因此施加于流体的压力大于在病人体内的流体压力,这样能使流体从远距离药源输送给病人。为了实现从病人到远距离药源的流体输送,病人体内的压力要大于远距离药源的压力,以形成从病人到远距离药源的流体流动。本发明也包括一种将一个容器内的流体输出的方法,该容器有一个开口,该开口由一个密封该开口的盖部件所覆盖。通过产生一个压力差可以引起流体从该容器流经该通道。该阀最好具有一个接合器,该接合器具有一个径向狭缝使之能充分地可逆地变形以紧密地配合在该容器上。
现在将详细地讨论说明了其全部特征的本发明的优选实施例。这些实施例描述了如附图所示的本发明的新的非显而易见的方法和阀,这些附图只是为了图解说明的目的。附图包括以下这些图,其中相同的数字表示相同的部件。
图1是本发明阀的第一个实施例的一个透视图。
图2是一个如图1所示阀的分解透视图,它表示了本发明的尖钉、密封件、壳体或外壳部件。
图3是图1的装配好的阀的一个纵向截面图。
图4是图1的装配好的阀在压缩密封件之前的一个示意纵向截面图。
图5是类似图4所示的阀在压缩密封件期间的一个示意纵向截面图。
图6是本发明第二个实施例的一个透视图。
图7是图6阀的一个纵向截面图。
图8是一个医疗器械的ANSI输出端压缩本发明阀的密封件的一个示意图。
图9是密封件的第三个实施例的一个部分剖视的侧视图。
图10是使用图9的密封件的图1的装配好的阀的一个纵向截面图。
图11是使用密封件的第四个实施例的图1的装配好的阀的一个纵向截面图。
图12是使用密封件的第五个实施例的图1的装配好的阀的一个纵向截面图。
图13是密封件的第六个实施例的一个纵向截面图。
图14是与图2所示的尖钉装置相连接的如图13所示的密封件的一个纵向截面图。
图15是本发明的密封件的第七个实施例的一个纵向部分剖视图。
图16是采用图15的密封件的阀的实施例在装配后的一个纵向截面图。
图17是本发明的阀的第八个实施例在装配后的一个纵向截面图。
图18是本发明的阀的第九个实施例在装配后的一个纵向截面图。
图19是图14所示的密封件和尖钉与图20和图21所示的壳体或外壳连接装配后的一个侧视图。
图20是一个沿图19中的线20-20的截面图。
图21是一个部分切开的透视图,用以表示容纳图13和14所示的密封件的腔的壁结构。
图22是一个大大地放大了的沿图14中的线22-22的截面图。
术语“近侧的”用于表示在或靠近图2至图5、图10至12、图14和图16中的尖钉尖端32以及在或靠近图6中的尖钉尖端60以及在或靠近图8、图9、图13至图19中的密封帽92的阀和其它部件的那一端。术语“远侧的”用于表示阀、或尖钉、或密封件的相反的那一端。术语“医疗器械”用于表示本领域的技术人员所公知的任何医疗器具,它可以与本发明相连接并便于通过本发明使流体(尤其是液体)流过。医疗器械的例子试图包括(但并不限于)管、导管、注射器、静脉注射装置(外周和中枢管线)、背负管线(piggyback  lines)、以及可用于与一个医用阀相连的其它部件。这些医疗器械以标准尺寸形式在商业上是可获得的。因此本发明阀的每一端或两端均可以装配为这些标准尺寸的医疗器械。
如图1和图2最好地所示,本发明的第一个实施例(阀10)包括一个阀壳体或外壳12,一个尖钉件24、和一个密封件36。密封件36由一种弹性材料制成,这种弹性材料是柔韧的、惰性的、流体不可透过的并且易被尖钉26刺穿。图13所示的实施例表示了一种变型的密封件36d,该密封件36d在其近端具有一个预先切割的狭缝11。这形成一个细小的孔,尖钉件24的尖端32可以容易地穿过该孔,但在尖钉件退回后仍形成一个流体密封。这三个部件如图3所示进行装配,将尖钉24封闭以防止意外的堵塞。图2表示了外壳12、密封件36和尖钉件24怎样连接在一起而无需使用任何粘合剂或其它粘结剂或方法。接着讨论所要实现的形成流体密封的机械连接。如图4和图5所示,密封件36移入外壳12内,用尖钉件24刺穿密封件36,露出尖钉件24的尖端32,以允许流体流经阀10。
参看图1,外壳12的一个优选实施例具有一个铃形的裙缘16和一个最好是圆柱形的上导管20。裙缘16与上导管20构成一个整体,并通过一个圆环14连接于上导管20。裙缘16形成尖钉件24的一个内导管18的一个护罩。这个内导管18最好是圆柱形的,并稍微呈锥形。内导管18和上导管20包括对准的中空管以使得当尖钉件24刺穿密封件36时内导管18与上导管20是相互流体连通的。在导管20的顶部有一个环形唇缘25围绕着圆形开口25a(见图2)。
在第一个实施例中,上导管20适于容纳一个ANSI标准注射器46的尖端或鼻锥(nose)48(见图4和图5)。然而,上导管20的外径试图具有能适应其它连接于其上的连接器装置的尺寸。上导管20的近端最好可以装备一个锁定机构,以便于将阀10锁定于多种连接器装置上。例如,参看图1,靠近外壳12的近侧唇缘25的锁定耳22最好被设置成使得外壳12可以被锁入对本领域的技术人员公知的Luer-Lock装置上。例如,参看图19,常用的Luer-Lock螺纹180可以设置在上导管20的外径上。
参看图2,尖钉件24在其远端具有内导管18并在其近端具有一中空的尖钉26,尖钉26与内导管形成一个整体。内导管18和尖钉26在使用期间对流体构成一个连续的通道。位于尖钉件24中部的一个环形套箍28与内导管18和尖钉26相互连接并与它们形成一个整体。如图3所示,套箍28的缘28a邻接在内环14的下侧,并具有一个环形棘瓜28b搭扣在环14下侧的一个环形槽14b内。套箍28具有两个功能。首先,它用作为一个连接环14下侧的连接装置。其次,它用作为一个对于密封件36的支撑和连接装置。
中空尖钉26具有一个尖削的圆锥形状,其端部为一个尖锐的尖端32。最好沿着尖钉的长度方向有隆起的凸出边缘30。这些边缘30从尖钉的表面伸出最好0.2至2.0毫米。边缘30最好如图2所示沿尖钉的长度方向直线对准。如下文所述当尖钉26被密封时这些边缘30用于破坏产生的任何真空。这些边缘的直线对准与定向的调整将结合它们的功能在下文讨论。紧挨着尖钉尖端32,有至少一个纵向的通孔34以允许流体在内导管18与上导管20之间的连通。在距离尖钉尖端32大约0.200英寸以内的位置处最好有三个通孔34。这些通孔34可以具有任何尺寸,然而,通孔的尺寸越大通过阀10的流体流动速率就越大。在一个优选实施例中通孔,34的尺寸是18个标准尺寸以提供三倍于一个18个标准尺寸的针的流动速率。
密封件36具有一个密封帽40,密封帽40具有一个一般的平顶表面40b、一个向外锥形的侧壁38和一个底唇42。其内部是中空的以形成一个圆锥形的腔37(见图3)。因而,密封件36容易在尖钉件24上滑动以将尖钉24紧密配合在腔37内。密封唇42被密封在环形套箍28内并被嵌在套箍28与环14的下侧之间。沿着密封件36的长度方向有纵向槽43(见图2),以形成气陷便于在使用期间密封件的36的压缩。槽43可以具有便于密封件压缩的可变形状或尺寸。在第一个实施例中,有一个单一的槽43在密封帽40与唇42之间完全围绕密封件36。
密封件36的底部具有这样一个宽度以使得密封唇42紧密地配合在环形套箍28内。密封件36的中空内部或腔37(见图3)最好是锥形的以与尖钉24的形状相适合,腔37具有一个壁部分44,它与尖钉24接触并在远端连接于密封帽40。密封件36的尺寸和形状做成使之能配合在外壳12的上导管20内。当顶表面40b高于通孔34时帽40重新密封阀10。帽40最好基本上充满导管20顶部的开口25a。因此在装配后,密封帽40的顶表面40b基本上与唇缘25同高,这样可以用酒精或其它消毒剂擦洗唇缘25和密封帽40而不会有消毒剂渗漏进阀10中。露出表面40b因而能用消毒剂擦洗这是十分重要的。
如图3最好地所示,与内导管18连接的尖钉24,通过环形套箍28外部与环形14内部的结合而被固定于外壳12上。尽管不是必须地,可以采用对本领域的技术人员公知的各种方法中的任何一种将这两个部件固定在一起,这包括(但并不限于)密封、胶合、压力锁定、粘结或类似方法。密封件36配合进环形套箍28中并通过一个内唇27沿着外壳12的环14的内部保持就位。尖钉24具有这样的长度以使得在装配后尖钉的尖端位于由外壳12的唇缘25限定的平面之下。尖钉尖端32位于外壳12的唇缘25之下最好约为0.525至0.1英寸。密封件36与尖钉24紧密配合并基本上与外壳12的唇缘25同高。于是尖钉尖端32在阀使用之前嵌入密封帽40内或者在阀10处于闭合位置时尖钉尖端可以距离密封帽40大约0.025英寸。外壳12的铃形裙缘16部分地遮护内导管18(见图1至图3)。铃形裙缘16的内表面最好具有凸出的螺纹44,作为用于连接一个医疗器械的任意锁定机构。此外,其它医疗装置可以通过压力配合在内导管18的外部上而无需直接与凸出的螺纹44相结合。
在使用期间,本发明设计成适于用作为一个二通阀。阀的定向不取决于流体流动而取决于事先存在连接的优选定向。因此,本发明可以用作在任一定向上的一个静脉注射中枢的或外周的背负连接器的阀连接器。通过管将不经肠道的流体输送给病人这样通过一根针液体从一个容器流入病人体内。常常需要更换容器或增加额外的流体瓶。在这里公开的本发明设计成沿着流体输送给病人的路径与医疗器械相互连接。然而,本发明也可以用于希望重复使用流体阀的任何环境中。在使用期间,一个合适尺寸的连接器配合在内导管18上。如上所述,采用一个Luer-Lock机构、一个压力装备或本领域的技术人员公知的任何其它锁定机构,可以实现锁定。因此,在一个例子中,流体从内导管18通过进入尖钉26。但是,流体流动被密封件36锁定就位。
图4和图5表示了阀的驱动。在图4中,连接于阀10近端上的医疗器械是一个注射器46。然而,这个连接着的器械可以是本领域的技术人员公知的任何医疗器械。注射器46的鼻锥48置于密封帽40上在外壳12的唇缘25内侧。如图4所示按箭头的方向对注射器施加压力,从而在密封帽40上产生压力。产生的向下压力压缩密封件36,进而推动尖钉26的尖端32穿过密封帽而露出通孔34。槽38有助于压缩。现在流体可以流入注射器46中,或反之亦然,这取决于是否流体从病人体内抽出或将药物注射入病人体内。图5表示了注射器46的鼻锥48插入开口25a而将阀10开启的情形,抽回注射器46中的注射活塞杆49,因而产生一个真空而将流体通过阀10抽进注射器,对于静脉注射应用,阀10可以按图4和图5所示的位置定向,或者旋转180°以使得流体以相反的方向流动。
当将注射器移开尖钉26时,如图4所示,密封件36自由地恢复到其原始形状并覆盖通孔34。密封件36恢复到其原始形状的能力取决于制造密封件36的材料的弹性。另外,在尖钉的外表面上形成的凸边30增加了密封件36恢复到其原始形状的能力。在压缩过程中,在尖钉26与密封件36之间的区域内可能形成一个真空,因而防止密封件36恢复到其原始位置。凸边30允许空气沿着尖钉/密封件的界面通过以防止形成真空并允许密封件自由地恢复。密封件36可逆地变形并恢复到其原始位置的能力是特别有用的,因为(1)它立即阻止了流体流经阀10,(2)它覆盖了凹入的尖钉26以保持其无菌,(3)它降低了尖钉无意中刺穿另一物体或人体的危险性。另外,由于阀10缺少可移动部分(除了密封件),因此当密封件36被推下时阀10失效的可能性不大。
通孔34一般设置在尖钉26上的比效低的位置处。因此,在密封件36恢复其原始形状而使阀10闭合的过程中,通孔34被较早地密封。在一个优选实施例中通孔34设置在尖钉尖端32之下0.075英寸(见图2)。另外,即使密封件36不能完全恢复到如图4所示的其原始形状,通孔34也能够被密封。此外密封件36可逆地恢复到其原始位置的能力允许连接器阀10的可重复使用。在注射器46与阀10分开之后,并且在阀10重新使用之前,被刺穿的密封帽40的表面基本上与外壳12同高。因此,这个同高的表面可以方便地用酒精或其它表面消毒物质进行消毒。裙缘16和上导管20有益地将阀内的连接与周围环境相隔离以保护阀内连接的无菌状态。此外,裙缘16和上导管20也作为蓄积囊以防止在操作期间流体从阀10滴漏。
一个盖帽(未示出)可以配合在上导管20上以在使用中进一步防护密封表面。但是,这样一个盖帽无需保持无菌,因为密封件36在每一次使用后都可以用一种消毒剂进行擦洗。密封件36的可回塑性使得阀10作为一个在两个流体管线之间形成流体连通的连接器阀是具有特别的吸引力。因此,本发明提供了采用在这里公开的阀将第一流体管线与第二流体管线连通的方法,阀10的可回塑性允许多个流体管线顺序添加于一条直接与一个病人的静脉连通的流体管线上。由于该阀容易消毒和密封,因此可以添加和移去流体管线而不用切断病人静脉的连接。
阀10最好由一种硬塑料制成,但也试图能由其它本领域技术人员公知的医用惰性材料来制成阀10。尖钉件24最好由与外壳12相同的材料制成。本发明的一个特殊优点是它不依赖于金属针的使用。这显著地减少了在使用和操作期间刺伤皮肤的危险性。此外,上导管20作为尖钉26的护罩进一步减少了尖钉刺伤皮肤的可能性。尖钉26的强度只需能够刺穿密封帽40,或如果需要,刺穿一个连接隔膜。
在如图2至图4所示的本发明的实施例中,通孔34设置在尖钉尖端32的末梢。这个位置具有两个重要的优点。首先,通孔34的这个位置便于阀10使用后的重新密封。其次,如果通孔设置在尖钉尖端32处,孔34可能会装入密封帽40的材料从而将密封件材料的细粒引入并随流体流动并可能堵塞孔34。因而在尖钉尖端32的末梢纵向地设置通孔防止了密封件材料细粒引进流体通道中和/或通孔34的堵塞。也试图实现根据不同的流体速度调整通孔34的数目和直径。在一个优选实施例中,通过通孔34的流体优选速度等于或大于通过18个标准尺寸的针的流动速率。大于18个标准尺寸的通孔当然便于更大速度的流体流动。
本发明的一个重要优点是阀10几乎没有死区,因此进入阀的液体体积基本上等于离开阀的流体体积。此外阀的总的等效流体容积非常小以使得流经将该阀与一个医疗器械(例如一个注射器46)连通的系统的流体体积基本上为零。
在本发明的另一个优选实施例中,如图6和图7所示,一个易处理的无菌接合器阀50用作一个流体容器(未示出)的可以重新密封的盖。于是流体可以以一种无菌方式从流体容器移动或允许从容器流动进入一个适用于室内流体(house  fluid)的医疗器械中。正如通常的实践中那样,容器的一个开口通常由一个盖子(未示出)密封。
图6表示了一个接合器阀50,它具有一个壳体,壳体包括一个接合器裙缘52。裙缘52最好紧密地配合在容器的开口上。裙缘52可以具有任何尺寸以适合多种容器的尺寸。最好沿裙缘的长度方向的至少一个位置设置一个纵向的狭缝54,以确保裙缘52与容器之间的紧密配合。最好是管状的一个腔56从裙缘52向上延伸并在结构和设计上类似于第一个优选实施例中的上导管20。类似于第一个实施例,阀的近端包含一个锁定机构59,它最好包括一个Luer-Lock装置或其它本领域的技术人员公知的锁定装置。
如图7所示,一个尖钉58向上延伸穿过管状腔56。尖钉尖端60最好位于管状腔56的近唇62之下。在一个闭合位置,这个尖端60被一个密封件64覆盖,这个密封件64基本上与密封件36相同。凸边66和密封槽68便于在开口位置密封件的压缩并促进使用之后的密封。因此,在如图7所示的闭合位置,密封件64覆盖通孔70以防止流体从容器流出。接合器阀50包含第二个尖钉72,它指向尖钉58的反方向。这两个尖钉58和72是流体相互连通的。尖钉72向下延伸至接合器裙缘52的内侧。这两个尖钉最好形成阀50的一个部件而裙缘52和上腔形成第二个部件。这两个部件以一种类似于阀10的方式进行装配。类似于尖钉58的尖钉72具有纵向通孔74和一个尖端76。通孔74设置在尖端76的内侧。因此接合器阀50可以与容纳无菌药物的容器一起使用,这些容器在其开口具有一个盖或隔膜密封件,试图用于本发明的具有这种密封件的容器的例子包括用于肌内注射器的抗菌素容器或类似物的剂量瓶。但是,人们也试图阀50能够通过其自身的密封件和锁定机构而使阀可以用于容纳药物或其它流体的各种容器。在这些类型的容器内的药物最好保持无菌状态并且药物的体积和性质使得每隔一段时间可以间歇地移去多个等分试样(multiple  aliguots)。如果药物是重新构成的,那么在使用期间,容器开口上的任何覆盖物都将被移去以露出橡胶隔膜。将接合器阀50置于隔膜上,直接施加压力使远端的尖钉72刺穿隔膜进入容器。如图4所示并结合第一个实施例,一个注射器或类似物可以用于从容器抽取流体。鼻锥48在尖钉58之上的压力推动尖钉尖端60刺穿密封件64。同时,密封件64被推下并被压缩。密封槽68容纳密封件的压缩。流体被从容器中抽出并且注射器从尖钉58移开。施加于密封件64上的压力释放允许密封件恢复到其原始形状。尖钉边缘66有助于密封件的可回塑性。
在购买时容器的成分通常是冻干的。冻干的成分在使用之前需要重新构成。如果药物在使用之前需要重新构成,那末在容器中的流体被抽出之前把无菌水、盐水、或其它流体引入容器中。阀的二通性允许这得以实现而无需任何特殊的接合。在注射器移去后,接合器阀50自动地密封。接着,可以用注射器或类似物从容器中移出等分试样在每一次使用之前,可以用酒精或其它合适的表面消毒剂擦洗唇缘62和密封件64。类似于第一个实施例,在使用期间试图设置一个帽配合在上腔唇缘62上。
接合器阀50可以用作一个静脉注射容器的药物接合器。在这种情况下,接合器阀50置于一个静脉输送药物容器上并通过管连接于一个静脉饲管。因此,接合器阀50可以与一个图1的连接器阀流体连通以便于药物从静脉滴注瓶的流动。
图9表示了密封件的一个变型的实施例,即密封件36a。密封件36a包括在其近端的一个密封帽92和在其远端的一个密封唇96。一个杯状的环形凸缘95紧贴着密封帽92设置。密封帽92和密封唇96通过一个密封壁相互连接,该密封壁由多个成圈状的壁部分94构成,壁部分94膨胀并扁缩而成一个手风琴状的形式。在密封件36a的压缩期间,成圈状壁部分94的直径在径向方向向外膨胀。在成圈状壁部分94与外壳之间有气陷13a(见图10),而在尖钉24与密封件36a之间也有气陷13a(见图10)。密封件36a在远离密封帽92并邻近成圈状壁部分94处包括一个腔98。密封件36a以类似于图2的密封件36的方式与尖钉26(见图2)以及本发明的其它部件相互作用。
参看图10,可以环绕着上导管20延伸杯状环形凸缘95并通过一个环97保持其就位。这产生一个类似蹦床的效果,即在一个注射器(未图示)抽出后协助密封件36a恢复到减压状态。这个实施例具有两个优点。第一,阀10的近端可以用酒精或其它消毒剂进行擦洗而不会使消毒剂渗漏进入阀10中。第二,通过环97将杯状环形凸缘95在密封件36a的近端固定到上导管20,这有助于密封件36a的重复变形和形状恢复。
图11结合阀10表示了密封件的一个变型的实施例,即密封件36b。密封件36b类似于密封件36a,它包括密封帽92、一个由成圈状壁部分94构成的侧壁和一个密封唇96。它也具有一个向外延伸的环99,环99与阀10的纵向轴成直角。这个环99用于将密封件36b连接于上导管20。一个上导管环形插塞20′最好插在上导管20内以在上导管20中的垂直环99、凸缘101与插塞20′之间产生紧密的配合。环99有助于密封件36b的形状恢复而当一个注射器(未示出)抽出之后密封尖钉26。
如图12所示,杯状形凸缘95和环99均可用来与阀10连接,以形成密封件36c。当一个注射器(未示出)抽出后这个密封件36c可以形成快速形状恢复并实现了密封件36a和36b的优点。
图13表示了密封件的另一个变型的实施例,即密封件36d。在这个实施例中,密封件36d包括密封帽92、密封唇96、和一个侧壁150,侧壁150由一连串相互堆积的圆形轮箍100构成,其中较小直径的轮箍是叠在相邻的较大直径的轮箍的顶部。这些圆形轮箍100最好贯穿其直径的整个截面是实心的。这些圆形轮箍100将随着密封件36d的压缩和减压而分别变形和恢复形状,因此可以露出或盖住一个尖钉(未示出)。
如上所述,密封件36d最好在帽92中沿着阀10的纵向轴方向有一个预先切割的狭缝11。密封帽92有一个独特的形状,该形状确保抽出一个注射器(未示出)后狭缝11闭合并被密封以及密封件36d的形状恢复。它包括一个放大的、内部、压敏元件200,压敏元件200与帽92构成一个整体。在侧壁150的近端与元件200之间是一个环形空隙102,其内充满了腔98中的流体。这个流体处于压力(例如阀10所连接的病人的血液压力)作用之下。参看图14,流体(例如病人的血液)经过孔34流入尖钉26,而充满腔102。该流体压向元件200的外侧,当密封件如图14至图19所示减压时封闭了狭缝11。来自该流体的压力产生一个高压密封,这防止了流体通过狭缝11溢出阀10。在元件200的端部有一个半圆柱形凸缘裂缝环104,它有益地延长了密封件36d的使用寿命。
最好,沿着元件200的内表面周边有一个裂缝环104,它与元件200构成一个整体,并且在密封件的外表面有一个浅盘状的凹陷204。压敏元件在减压状态封闭密封件36d中的任何孔隙以在减压状态基本上形成一个流体密封。甚至在有时医疗应用中遇到的(尤其是当阀10连接于一个病人的动脉时)非常高的压力的情况下,压敏元件200仍能使阀保持流体密封。元件200和环形空隙120的中心与孔11的入口11a同轴。加压流体充满环形空隙102以施加压缩元件200的压力,因而紧密地封闭孔隙的入口。在一个优选实施例中,从入口11a到密封帽92近端的距离是0.500至0.075英寸并且最好大约是0.100英寸。
如图22最好地所示,尖端32设计成避免刺破密封件。尖端32有三个刻面210、212和214,它们沿着接合线a、b和c相互连接。刻面210、213和214的接合处常常是粗糙的并将刺破密封件36d。通过将接合线a、b和c或接合处分别置入凹座220、222和224中,这样形成一个“埋入接合线”因此防止了刺破密封件。
采用密封件36d的本发明的另一个变型的实施例如图8和图19至图21所示。在这个实施例中,导管20上端的内壁160设置有至少一个、最好多个的径向凹槽107。如果阀10是一个对称的星形形状,凹槽107一般是细长的平行于纵向轴设置。每一个凹槽107都具有相对的横向边162,当密封件36d压缩时这些横向边162与密封件36d贴合。这些凹槽为密封件36d提供了压缩时密封件36d的伸胀空间。
如图8最好地所示,导管20近端的壁181向内锥削的角度与注射器46的鼻锥48的角度相同。根据ANSI标准,该锥度为每长度英寸(linear  inch)0.006英寸。当注射器鼻锥滑入开口25a向内推动密封件36d并向内压缩密封件36d迫使尖钉36的尖端32进入狭缝11时,注射器鼻锥48靠压着壁181。当压缩时密封件36d伸胀而基本上完全充满凹槽107的上部。密封件36d的某些部分嵌入边162之间,另一些部分充满凹槽107。当液体经过孔34流经鼻锥48时,鼻锥48内的空气被排出鼻锥并从壁181和182之间被排出阀10。因此所有规定剂量的药物基本上经过阀10输送给病人。流体流经通孔34,但是没有渗漏在密封件36d与壁181之间以及相邻的壁181和182之间。
图15、16、17和18表示了密封件的实施例,即密封件36e、密封件36f和密封件36g,它们基本上与密封件36a(图10)、密封件36b(图11)和密封件36c(图12)相同,除了用圆形轮箍100构成的侧壁150代替相应的手风琴状壁部分94。
与密封件的各种实施例相互作用的本发明其它部件采用与图2的密封件36相互作用的部件相似的方式。在阀10使用之前,最好用一个钢针在轴向方向上中心地刺穿密封帽40或92,以预先切割密封件而形成狭缝11,因而当密封件被尖钉26刺穿时允许密封件更快地减压和恢复形状。密封件最好由一种能够重复密封并阻止流体围绕密封件材料流动的材料制成。密封件36也应当能够被压下并弹回以重新密封阀。太柔软的材料可有效地重复密封;但在阀打开后将不能弹回。太硬的材料具有足够的弹力;但不能有效地密封。因此在一个优选实施例中,密封件由一种30至70肖氏硬度的硅酮制成,并且最好由40至50肖氏硬度的硅酮制成。一种在最佳硬度范围内的塑化硅酮聚合物可从美国密歇根州阿德里安市的Wacker硅酮公司获得。在本发明的某些实施例中,人们希望给密封件36提供额外的润滑性能以允许密封件更有效地弹回和重新密封。Dow化学公司生产了一种具有这种额外润滑性能的内藏硅酮油的硅酮成分。
一般来说,阀10的闭合并不是由直接覆盖通孔34的密封件36侧壁实现的,而是由充满腔98的近端和开口25a的密封帽40或密封帽92实现的。因此,密封帽40和92足够的厚以在阀闭合后有效地重新密封开口25a。然而,密封帽40和92也应足够的薄以允许它们容易恢复到其闭合装置。帽40和92的厚度范围最好在0.075至0.500英寸之间并且更好地可大约为0.1英寸。
本发明的阀可以设置成一种无菌的且易处理的方式,因此在一个给定的装置中使用之后阀被用尽,这样可以丢弃该设备。然而如上所述,在任何给定的装置中,阀可以多次重复使用。由于本发明的装置不使用针,因此几乎不会对皮肤造成无意刺伤。所以消除了处理和处置针所需要的额外预防措施。从这里进行的详细描述可以明显地看到,本发明可以消除在医疗环境中使用的几乎所有的针。使用本发明的阀,可以有益地消除所有针的需要,除了直接输进病人体上的情形之外。
阀口用于提供一个密闭的将介质输入到病人体内的系统,它将一个预定剂量的药物从一个远距离药源输送给病人。阀10的远端连接于病人,例如一个静脉或动脉与阀流体连通。血液充满阀,但是密封件36d阻止任何血液从阀中渗透。如图8所示,医疗器械的输送端或鼻锥48插入阀内,鼻锥48推压密封件以充分地压缩密封件,这样使尖钉24的尖端刺穿密封件并进入所说输送端。预定剂量的药物可以经过鼻锥48进入阀10并完全输入病人体内。由于鼻锥48与密封件36d以这样一种方式接合,因此当尖钉件24的尖端32刺穿密封件时,它使密封件避免了在鼻锥48与密封表面40b之间的界面处任何死区的形成。由于全部预定剂量的药物基本上从注射器46经过阀10直接输送给病人,所以本发明实现了基本上没有任何剂量药物聚积在阀的任何死区内。当从阀10中抽出鼻锥48后,密封件36d恢复到其减压状态以闭合阀,并且甚至在高压和重复作用后仍能保持该减压状态形成流体密封。
以上用如此完整、清楚、简明、和精确的术语描述了实施本发明的预期的最好模式以及制造和使用它的方式和方法,以致于本领域的任何技术人员能够实现和作用本发明。然而,本发明也允许作出与以上讨论的完全等价的各种变型和替换结构。因此本发明不是仅限于公开的特定的实施例。恰恰相反,本发明的目的在于覆盖由下面的权利要求书一般地表述的本发明的精神实质和范围内的所有变型和替换结构,权利要求书特别指出并清楚地表述了本发明的主题。

Claims (59)

1、一种医用阀包括:
一个壳体,它包括限定一个内腔的壁结构,该内腔具有一个近端和远端,
所说近端具有一个足够大的开口以容纳一个医疗器械的输送端,该医疗器械通过所说输送端传送流体;
一个尖钉,它具有一个尖端、设置在或靠近所说尖端处的至少一个孔、以及一个与该孔连通的通道,它允许流体流经所说孔,
所说尖钉安置在该腔的内部以使得所说尖端被封闭在该腔内;以及
一个弹性密封件,当该医疗器械的端部插入所说开口时弹性密封件变成压缩状态,而当该医疗器械的端部移出时该弹性密封件变成减压状态,在减压状态下所说密封件具有一个段,它基本上完全充满靠近所说开口的腔的一部分,所说密封件段靠压在邻近所说开口的壁结构上以密封所说开口,而在压缩状态下该医疗器械的输送端将所说密封件段推离该开口并进入该腔内。
2、如权利要求1所述的医用阀,其特征在于,当所说密封件变成压缩状态时在所说密封件段与该壁结构之间保持着流体密封,当该医疗器械的端部将该密封件推移进入该腔内时所说密封件段靠压在该壁结构上。
3、如权利要求1所述的医用阀,其特征在于,该密封件具有与所说近端基本上同高的一个表面。
4、如权利要求3所述的医用阀,其特征在于,该密封件具有一个基本上平坦的近端。
5、如权利要求1所述的医用阀,其特征在于,它包括一个连接于该尖钉的支座部件,该支座部件密封所说内腔的远端,所说支座部件具有一个Luer-Lock型连接器元件,它能使所说阀可拆装地连接于一个接于病人的流体管线上。
6、如权利要求1所述的医用阀,其特征在于,它包括一个连接于该尖钉的支座部件,该支座部件密封所说内腔的远端,所说支座部件具有一个连接器元件,它能使所说阀可拆装地连接于一个流体分配器上。
7、如权利要求1所述的医用阀,其特征在于,该孔位于该尖钉的靠近其尖端的一侧。
8、如权利要求1所述的医用阀,其特征在于,该密封件包括一种具有30至70肖氏硬度的材料。
9、如权利要求8所述的医用阀,其特征在于,该密封件材料是一种硅酮聚合物。
10、如权利要求1所述的医用阀,其特征在于,该密封件包括堆积在一起并相互连接形成一个单一结构的一连串O形环元件。
11、如权利要求10所述的医用阀,其特征在于,该O形环元件具有递增的直径,靠近腔近端的元件的直径最小。
12、如权利要求1所述的医用阀,其特征在于,该腔具有在靠近该密封件的内壁的多个径向凹槽,以容纳当该密封件压缩时该密封件的伸胀。
13、如权利要求1所述的医用阀,其特征在于,预先切割该密封件以在其中形成一个细小的孔隙,当压缩该密封件时允许该尖钉的尖端容易穿透该细小的孔隙。
14、一种与一个通过锥形输送端输送流体的医疗器械一起使用的医用阀,它包括:
一个壳体,它包括限定一个内腔的壁结构,该内腔具有一个近端和一个远端,所说壁结构呈向内锥形以使得当该输送端插入该内腔的开口时所说壁结构与所说锥形的输送端相互紧密地配合,
所说近端具有一个足够大的开口以容纳所说输送端;
一个中空尖钉,它具有一个尖端和设置在该尖端或靠近该尖端的至少一个孔,
所说尖钉安置在该内腔中以使得所说尖端被封闭在内腔中;
一个连接在该尖端上的支座部件,它密封所述内腔的远端;以及
一个弹性密封件,当该医疗器械的端部插入所说开口时该弹性密封件变成压缩状态,而当该医疗器械的端部移出时该弹性密封件变成减压状态,在减压状态下所说弹性密封件具有一个段,它基本上完全充满靠近该开口的该腔的一部分并覆盖所说尖端,所说密封件段靠压在邻近所说开口的所说壁上以密封所说开口,而在压缩状态下医疗器械的输送端将所说密封件段推离该开口并进入该腔内。
15、如权利要求14所述的医用阀,其特征在于,当所说密封件变成压缩状态时在密封件段与壁结构之间保持着流体密封,当医疗器械的端部将该密封件推移进入该腔内时所说密封件段靠压在该壁结构上。
16、如权利要求14所述的医用阀,其特征在于,该密封件具有与所说近端基本上同高的一个表面。
17、如权利要求16所述的医用阀,其特征在于,该密封件具有一个基本上平坦的近端。
18、如权利要求14所述的医用阀,其特征在于,该支座部件具有一个Luer-Lock型连接器元件,它能使所说阀可拆装地连接于一个接于病人的流体管线上
19、如权利要求14所述的医用阀,其特征在于,该支座部件具有一个连接器元件,它能使该阀可拆装地连接于一个流体分配器上。
20、如权利要求14所述的医用阀,其特征在于,该孔位于该尖钉的靠近其尖端的一侧。
21、如权利要求14所述的医用阀,其特征在于,该密封件包括一种具有30至70肖氏硬度的材料。
22、如权利要求21所述的医用阀,其特征在于,该密封件材料是一种硅酮聚合物。
23、如权利要求14所述的医用阀,其特征在于,该密封件包括堆积在一起并相互连接形成一个单一结构的一连串O型环元件。
24、如权利要求23所述的医用阀,其特征在于,该O形环元件具有递增的直径,靠近该密封件近端的元件的直径最小。
25、如权利要求14所说所述的医用阀,其特征在于,该腔具有在靠近该密封件的内壁的多个径向凹槽,以容纳当该密封件压缩时该密封件的伸胀。
26、如权利要求14所述的医用阀,其特征在于,预先切割该密封件以形成一个细小的孔隙,当压缩该密封件时允许该尖钉件的尖端容易穿透该细小的孔隙。
27、如权利要求14所述的医用阀,其特征在于,该壳体具有一个靠近该腔的远端的第一锁定件,该尖钉具有一个第二锁定件,它适于与该第一锁定件互锁,并且该密封件具有一个延伸超出该远端并位于该第一和第二锁定件之间的唇缘,以使得当该第一和第二锁定件互锁并将该唇缘压缩在其间时所说唇缘基本上形成一个流体密封。
28、如权利要求27所述的医用阀,其特征在于,该密封件具有一个置于该腔内的截头圆锥段。
29、如权利要求14所述的医用阀,其特征在于,所说密封件包括一个杯状凸缘,它适于在靠近该腔的近端与所说壳体接合。
30、如权利要求14所述的医用阀,其特征在于,所说密封件具有一个气陷以便于该密封件的移动。
31、如权利要求14所述的医用阀,其特征在于,所说尖钉包括至少一个肋以允许空气进入所说密封件与所说尖钉之间的空隙,从而当移开所说器械时便于所说开口的密封。
32、如权利要求14所述的医用阀,其特征在于,该阀适合于与一个器械相互接合,该器械可以是注射器、静脉注射装置和导管。
33、如权利要求14所述的医用阀,其特征在于,所说腔的近端适合于与所说医疗器械的一个ANSI标准端紧密配合。
34、如权利要求14所述的医用阀,其特征在于,该尖钉具有至少3个孔。
35、如权利要求34所述的医用阀,其特征在于,所说孔具有18个标准尺寸或更大。
36、如权利要求14所述的医用阀,其特征在于,该阀包括一个将其连接于一个容器上的接合器。
37、如权利要求36所述的医用阀,其特征在于,该接合器具有一个尖钉,当将该阀连接于该容器时该尖钉适合于刺穿该容器上的一个密封件。
38、如权利要求36所述的医用阀,其特征在于,在所说接合器上有一个径向狭缝以允许该接合器充分地可逆地变形以紧密地配合在所说容器上。
39、一种医用阀,它包括:
一个外壳,它具有限定一个内腔的壁结构,该内腔具有一个近端和一个远端,在该近端处有一个开口,在该远端处有一个第一个锁定件;
一个尖钉,其内具有一个流体通道,以允许流体流经该通道,所说尖钉具有一个第二锁定件,它适于与所说第一锁定件互锁,
所说尖钉包括一个尖端并被安置在该腔内以使得该尖端靠近该近端且被封闭在该腔内;
一个弹性密封件,它被设置在该腔内并覆盖所说尖端,当该医疗器械的端部插进所说开口时该弹性密封件变成压缩状态,而当所说端部移出时该弹性密封件变成减压状态,
在减压状态下所说密封件具有一个段,它基本上完全充满靠近所说开口的腔的一部分,所说密封件段靠压在邻近所说开口的壁结构上以密封所说开口,而在压缩状态该医疗器械的输送端将所说密封件段推离该开口并进入该腔内,
所说密封件具有一个延伸超出该远端并位于第一和第二锁定件之间的唇缘,以使得当第一和第二锁定件互锁时该唇缘基本上形成一个流体密封。
40、如权利要求39所述的医用阀,戎特征在于,该尖钉具有一个基本上圆锥形的形状并且该密封件具有一个与该尖钉的形状相适合的基本上圆锥形的腔,所说尖钉置于该腔内并且该密封件覆盖所说尖端。
41、如权利要求39所述的医用阀,其特征在于,该阀适合于与一个医疗器械一起使用,该医疗器械通过一个锥形输送端输送流体,所说近端具有一个足够大的开口以容纳所说输送端,并且所说壁结构呈向内锥形以使得当该输送端插入该开口时所说壁结构与所说锥形输送端相互紧密地配合。
42、一种医用阀,它包括:
一个通常的管状壳体,它限定一个内腔并具有一个近端和一个远端,所说壳体的近端具有一个足够大的开口以容纳一个医疗器械的一个ANSI标准尖端;
一个中空尖钉,它具有一个被封闭的尖端,该尖钉包括多个位于该尖端内的孔,该尖钉安置在该壳体内部以使得所说尖端位于该壳体的近端内;
一个支座部件,它连接于该尖钉,该支座部件密封该壳体的内腔的一部分以使得形成一个包含该尖钉的尖端的上腔;
一个塑料的、弹性的硅酮密封件,它充满上腔并覆盖尖钉的尖端以致形成一个基本上平坦的表面。
43、一种与一个适于输送流体的医疗器械接合的阀,它包括:
一个中空尖钉,它具有一个远端和一个近端,所说尖钉在其近端有一个尖端并在该尖端内至少有三个孔,这些孔可与所说医疗器械流体连通;
一个密封件,它适合于配合在该尖钉上并可逆地密封这些孔,当所说医疗器械与该连接器阀接合时所说密封件适合于可逆在开启这些孔;
一个外壳,它至少部分地包含所说尖钉和密封件。
44、一种从一个远距离药源将流体输送给一个病人的方法,它包括以下步骤:
(a)将一个医用阀连接在病人上,该医用阀包括:
一个壳体,它包括限定一个内腔的壁结构,该内腔具有一个近端和一个远端,
所说近端具有一个足够大的开口以容纳一个医疗器械的输送端,该医疗器械通过该输送端输送流体,
一个尖钉,它具有一个尖端、设置在该尖端或靠近尖端的至少一个孔,以及一个通道,它与该孔流体连通以允许流体流经该孔,
该尖钉安置在该腔的内部以使得所说尖端被封闭在该腔内,以及
一个弹性密封件,当该医疗器械的端部插入该开口时该弹性密封件变成压缩状态,而当该医疗器械的端部移出时弹性密封件变成减压状态,所说密封件在减压状态具有一个段,它基本上完全充满靠近该开口的该腔的一部分,所说密封件段靠压在邻近该开口的该壁结构上以密封该开口,并且在压缩状态该医疗器械的输送端将该密封件段推离该开口并进该入腔内;以及
(b)将该医疗器械的输送端插入该开口并把所说输送端推进该腔,以充分地压缩该密封件,并允许该尖钉的尖端进入该输送端,从而把流体从该远端距离药源输送给病人。
45、如权利要求44所述的方法,其特征在于,将流体输送给该病人是这样实现的,即当流体经过该器械时给流体施加压力,以使得施加于流体的压力大于在病人体内的流体压力,从而使流体从远距离药源输送给病人。
46、如权利要求44所述的方法,其特征在于,在病人体内的流体压力大于在远距离药源处的压力,从而使流体能从病人输送到远距离药源。
47、如权利要求44所述的方法,其特征在于,该阀适合于具有二通性所以允许流体既可以流入病人体内也可以从病人体内流出。
48、一种输送一个容器内流体的方法,该容器具有一个开口,该开口被一个盖部件覆盖,该盖部件密封该开口,该方法包括以下步骤:
(a)将一个医用阀连接在该容器上,该阀包括:
一个壳体,它包括限定一个内腔的壁结构,该内腔具有一个近端和一个远端,
所说近端具有一个足够大的开口以容纳一个医疗器械的输送端,该医疗器械通过该输送端输送流体,
一个尖钉,它具有一个近侧尖端、一个远侧尖端、以及一个将近侧尖端与远侧尖端相互连通以允许流体流经的通道,
所说尖钉安置在该腔的内部以使得近侧尖端被密闭在该腔内并位于该近端的内侧,所说远侧尖端向外延伸以使得当该阀连接于该容器时该远侧尖端刺穿所说盖部件,
一个弹性密封件,当该医疗器械的端部插入该近端的开口时该弹性密封件变成压缩状态,并且当该医疗器械的端部移出时该弹性密封件变成减压状态,该密封件在减压状态具有一个段,它基本上完全充满靠近所说开口的该腔的一部分,所说密封件段靠压在邻近所说开口的该壁结构上以密封所说开口,而在压缩状态下该医疗器械的输送端将所说密封件段推离该开口并进入该腔内;以及
(b)将该医疗器械的输送端插入该开口并把所说输送端推进该腔,以充分地压缩该密封件,并允许该尖钉的近侧尖端进入所说输送端,从而可以从该容器输送流体。
49、如权利要求48所述的方法,其特征在于,通过产生一个压力差而使流体从容器流经该通道。
50、如权利要求48所述的方法,其特征在于,该阀具有一个接合器,该接合器具有一个径向狭缝以允许该接合器充分地可逆地变形以紧密地配合于该容器。
51、一种将一个预定量的药物从一个远距离药源输送给一个病人的方法,它包括以下步骤:
(a)将一个医用阀连接在病人上,该阀包括一个足够大的开口以容纳一个医疗器械的输送端,该医疗器械通过该输送端将预定量的药物输入该阀,该阀包括一个被封闭的尖钉,该尖钉具有一个尖端,该尖端内有一个孔,该阀还包括一个弹性密封件,当该医疗器械的输送端插入所说阀中时通过输送端使弹性密封件变成压缩状态,并且该医疗器械的输送端移出时该弹性密封件变成减压状态以闭合该阀,所说输送端与所说密封件适于接合以使该尖钉的尖端刺穿该密封件并且在所说输送端与该密封件之间不存在死区;
(b)将该医疗器械的输送端插入该阀并将该输送端推向所说密封件以充分地压缩密封件,从而允许该尖钉的尖端刺穿密封件并进入输送端,所说密封件与输送端接合以基本上消除任何死区;
(c)直接通过所说阀基本上将全部预定量的药物从远距离药源输送给病人,因此所说预定量的药物基本上没有聚积在该阀的任何死区中;
(d)从该阀中抽出医疗器械的输送端,以使密封件恢复到减压状态以闭合该阀,甚至在高压和重复使用的情况下仍能在减压状态下保持流体密封。
52、一种医用阀包括:
一个壳体,它包括一个内腔,该内腔具有一个近端和一个远端,
该近端具有一个足够大的开口以容纳一个医疗器械的输送端,该医疗器械通过该输送端输送流体,
一个尖钉,它具有一个尖端和带有一个孔的通道,以允许流体流经该通道,以及
一个弹性密封件,当该医疗器械的端部插入该开口时该弹性密封件变成压缩状态以打开该阀,而当该医疗器械的端部移出时该弹性密封件变成减压状态以闭合该阀,
当该密封件被压缩时它被尖钉刺穿,并且该密封件具有一个包括一个压敏元件的近端,该压敏元件设置在靠近开口的密封件的一个内表面上,在减压状态时所说压敏元件封闭在所说近端的密封件内的任何孔隙以基本上形成一个流体密封。
53、如权利要求52所述的医用阀,其特征在于,该压敏元件是该密封件的一段,它包括进入该密封件的近端的一个预先切割的孔隙的入口,该密封件段被一个容纳压缩流体的空隙所围绕。
54、如权利要求52所述的医用阀,其特征在于,所说尖端具有多个刻面,它们埋在一个凹座内。
55、如权利要求52所述的医用阀,其特征在于,该密封件包括堆积在一起并相互连接形成一个单一结构的一连串O形环元件。
56、如权利要求55所述的医用阀,其特征在于,该O形环元件具有递增的直径,靠近该密封件近端的元件的直径最小。
57、如权利要求52所述的医用阀,其特征在于,在该壳体内有一个腔,它具有在靠近该密封件的一个内壁内的多个径向凹槽,以容纳当该密封件压缩时该密封件的伸胀。
58、如权利要求52所述的医用阀,其特征在于,该输送端与该密封件适于接合,以使得当该尖钉的尖端刺穿该密封件时在该输送端与该密封件之间基本上不存在死区。
59、如权利要求52所述的医用阀,其特征在于,该密封件的近端有一个中心设置的、反压力的、盘状凹陷,并且该压敏元件具有一个抗刺破元件。
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HU9401728D0 (en) 1994-09-28
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US7722576B2 (en) 2010-05-25
EP0988871B1 (en) 2004-03-24
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