CN100406075C - 用于安置皮下输液器的注射器装置 - Google Patents

用于安置皮下输液器的注射器装置 Download PDF

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CN100406075C
CN100406075C CNB028188772A CN02818877A CN100406075C CN 100406075 C CN100406075 C CN 100406075C CN B028188772 A CNB028188772 A CN B028188772A CN 02818877 A CN02818877 A CN 02818877A CN 100406075 C CN100406075 C CN 100406075C
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plunger
injection device
syringe needle
crust
intubate
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CN1558782A (zh
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拉斯·W·莫恩森
马格努斯·W·约兰松
格雷特·科内鲁普
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Unomedical AS
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0612—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
    • A61M25/0631—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders having means for fully covering the needle after its withdrawal, e.g. needle being withdrawn inside the handle or a cover being advanced over the needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A61M2005/1581—Right-angle needle-type devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A61M2005/1585—Needle inserters

Abstract

一种注射器装置，它具有带有基本上不可拆卸地固定在其上的医用针头的柱塞，并且用来方便迅速地使皮下输液器的插管通过病人的皮肤经皮安置，所述插入针头延伸穿过输液器并且从插管的端部伸出。

Description

用于安置皮下输液器的注射器装置
技术领域
本发明大体上涉及一种用于将皮下输液器安置在病人上的改进的注射器装置。在US 6093172、US 5851197和WO99/33504中披露了用于安置皮下输液器的注射器装置的示例，这些文献在这里被引用作为参考。
背景技术
医用针头广泛用在病人治疗过程中，尤其用于输送选定药物。在一个形式中，采用中空皮下注射针来从针筒等经皮输送药物，参见US 5665071。在另一个形式中，采用与注射器装置结合使用的插入针头来经皮安置柔软且相对柔性的管状插管，之后除去该插入针头并且随后通过该插管给病人注射药液。US 5681323涉及一种用于紧急环形甲状膜切开管的插入装置。
病人常常需要自己经皮安放医用针头。例如，糖尿病人经常安放具有插管的皮下输液器以便随后通过医用注射泵来输送胰岛素。例如，在US 4755173、US 5176662、US 5275980和WO98/58693中披露了这种皮下输液器，这些文献在这里被引用作为参考。
一些病人不愿意医用针头刺穿他们的皮肤，因此在校正针头放置以正确给药中碰到困难。这些困难可以归因于人工技能不足以实现正确的针头安置或者归因于在针头刺透皮肤时与所预期的不适相关的焦虑。这个问题在用皮下输液器输送药物的情况中尤为明显，因为不正确的安置会造成插管扭曲，从而导致流向病人的药物流受阻。插管扭曲是由于输液器相对于病人皮肤成不正确的角度安置和/或以不正确的力和插入速度安置针头。
本发明其目的在于提供一种改进的注射器装置，它可以缩短安置输液器所需要的总时间。本发明其目的还在于提供一种改进的弹簧式驱动器，用来将外壳内的柱塞推向前进位置。
发明概述
根据本发明，一注射器装置具有一带有医用针头的柱塞，该针头是中空的以使得在将输液器准备好时能够排出药物，并且适用于将皮下输液器的插管迅速且方便地经皮安置穿过病人的皮肤，所述插入针头延伸穿过输液器并且从插管的端部伸出。该注射器装置设计成将插管安置成优选以受控的力和插入速度使插入针头从中延伸穿过，从而确保正确的针头安置同时使病人的不适最小。该注射器装置还可以以选定的插入角度将插入针头安置穿过皮肤。在准备好并且安置好输液器之后，拆除该注射器装置并且开始进行给药。
优选的是，以无菌密封的一次性使用组件形式将该注射器装置提供给病人，该组件包括具有已经安装在注射器装置的插入针头上的外壳的皮下输液器，由此减少了在安置皮下输液器之前由病人操纵的部件数量。该注射器装置组件可以如此设计，从而不再需要任何其它包装，从而导致成本大大降低。
更具体地说，该注射器装置包括优选具有一细长孔的装置外壳以及可滑动地容纳在其中以便在一前进位置和一回缩位置之间运动的柱塞，所述柱塞具有基本上不可拆卸地固定在其上的一插入针头，用来将所述插管容纳并且支撑在这样一个位置中，从而使插管取向成在具有所述针头的柱塞从所述回缩位置向前进位置运动时经皮安置。驱动器以受控的力和速度从回缩位置将柱塞推向前进位置以经皮安置容纳在所述插入针头上的所述皮下输液器的所述插管。在柱塞上的插入针头可以从所述插管拆除同时使该插管保持经皮安置。在本申请中所使用的“基本上不可拆卸地”指的是这样一种连接，该连接将在正常使用条件下保持稳定，从而在使注射器装置从病人皮肤缩回时让针头保留在柱塞上。
优选的是，该注射器包括一弹簧加载柱塞，它具有用来将输液器容纳在这样一个位置中，从而插入针头向外伸出以便经皮安置穿过病人皮肤。外壳的前端设计用来在选定的针头插入位置处并且在针头以正确或所要求的插入角度设置的取向中压靠在病人皮肤上。触发部件可以操作用来松开柱塞，由此允许驱动弹簧以受控的力和速度带着输液器朝着病人皮肤运动，从而导致正确经皮安置插入针头并且使病人的不适最小。
本发明还涉及一种新颖的弹簧式驱动器，用于将注射器装置的柱塞推向前进位置，优选用于经皮安置皮下输液器，其中所述驱动器包括多个单独细长的柔性塑料部件，它们优选在位于柱塞和装置外壳之间的环形空间中围绕着柱塞周边的相应部分延伸。每个部件与柱塞和装置外壳连接。在柱塞的前进位置中，这些塑料部件基本上是平面并且没有变形。但是，当使该柱塞移动至回缩位置时，这些塑料部件弯曲，从而设定准备将柱塞驱动至前进位置所需要的力。该新颖的弹簧式驱动器也可以应用于在US 6093172、US 5851197和WO99/33504中所披露的那种注射器装置，其中柱塞头没有安装在其上用来容纳输液器的插入针头，但是包括用来容纳并且支撑皮下输液器的凹槽。
附图的简要说明
这些附图举例说明了本发明。
图1为一透视示意性垂直剖视图，显示出体现了本发明新颖特征的注射器装置；
图2为在图1中所示的注射器装置的示意性剖视图，其中除去了端盖；
图3为图1的注射器装置的示意性剖视图，所述柱塞处于前进位置并且在安置皮下输液器之后；
图4为类似于图4的视图，其中安置了端盖以便保护伸出的插入针头；
图5为一分解透视图，显示出注射器装置的柱塞和外壳部件；
图6为高度示意的垂直局部剖视图，显示出在使用之前的根据本发明第二实施方案的注射器装置；
图7为类似于图6的视图，显示出准备使用的注射器装置；
图8为准备好的注射装置的类似于图6的视图；
图9为类似于图6的视图，其中柱塞回缩并且注射器装置准备好用于经皮安置输液器；
图10为类似于图6的视图，其中输液器被安置在病人上；
图11为类似于图6的视图，其中注射器装置从安置在病人上的输液器中拆除；
图12为在图6-11中所示的水平透视剖视图，显示出其柱塞处于前进位置中的弹簧式驱动器；
图13为一透视图，显示出在使用之前的根据本发明第三实施方案的注射器装置；
图14为图13的装置的透视局部剖视图；
图15为类似于图14的视图，显示出处于前进位置中的柱塞；
图16为一分解透视图，显示出图13-15的注射器装置的各种部件；
图17为适用于与本发明的注射器装置一起使用的输液装置的透视图；并且
图18为一剖视图，显示出如何使用中空插入针头来准备输液器。
优选实施方案的详细说明
在图1中由参考标号10示意性所示的注射器装置用于迅速且方便地安置皮下输液器14，然后可以安全地丢弃。只是示意性地显示出具有从中延伸出的插管26的输液器14。
该注射器装置10包括一柱塞30，它在其上具有带有尖端12A的医用插入针头12。柱塞30布置用来在装置外壳30内在向前的前进位置(图3和4)和向后的回缩位置(图1和2)之间纵向滑动运动。该装置外壳28可以具有圆形、方形或任意所要求的横截面形状。该装置外壳28和柱塞30优选在模制工艺中由塑料材料形成。
该输液器14用来给病人灌输药液例如胰岛素，并且通常包括具有内部腔室(未示出)的外壳，该腔室通过输液管道接收药物。该输液器14的放大基底24设在外壳上以便其稳定地固定在病人皮肤上。放大的基底24可以带有粘合剂，并且设有剥离片14′，在安置该输液器之前去除该剥离片以暴露出粘合剂。或者，基底24其尺寸可以设定成使得该输液装置能够通过粘性片固定在病人上。该输液器具有伸出的柔软且柔性的插管26，它与内部腔室连通，并且由密封薄膜密封的通道延伸穿过与插管26相对的外壳。在将输液装置14安装在注射器装置上的适当位置中时，注射器装置10的医用插入针头12延伸穿过该通道进入内部腔室并且穿过插管26。在经皮安置好插管26之后，使具有插入针头12的注射器装置10从输液器14缩回以允许通过该插管26给病人输送药物。
在US 4755173、US 5176662和US 5257980以及EP956879和WO98/58693中显示并且描述了适用于与本发明的注射器装置一起使用尤其与注射器装置的插入针头结合使用的皮下输液器的示例，这些文献在这里被引用作为参考。这些输液器通常包括一中空插管部件。通过本发明可以省去在这些公开出版物中所示的插入针头。或者，根据本发明的注射器装置可以经皮安置与其它类型的输液器相关的插管。
本发明提供使用可以由合适的塑料材料模制而成的注射器装置的准备。由于由工厂提供的组件提供了已经安装在插入针头12上的输液器，所以包括注射器装置和皮下输液器的注射器装置组件将有效地简化了输液器的安置。因此，减少了安置输液器所需要的时间。
该注射器装置10包括一触发式促动器机构，用于以受控的速度和力来经皮安置固定在柱塞30上的插入针头12，并且按照大体上如在被引用作为参考的WO99/33504中所示的方式相对于病人皮肤将插入针头12定位在倾斜位置处。
柱塞30在其下端或前端处具有一带凹槽的头部32(图3)，该端部成形用来容纳皮下输液器14的外壳。在凹槽中的中央位置处，该头部32设有金属插入针头12，该针头固定连接在其上。插入针头12可以例如在模制该柱塞30的过程中按照任意适当的方式与柱塞连接，或者插入针头12可以压配在柱塞30中。在给输液器14的拆除提供阻力的意义上在柱塞头部32中的凹槽不必为输液器14提供支撑。这种支撑可以单独由插入针头12与插管26或者优选与在输液器14的内部腔室内的密封薄膜的摩擦接合提供。柱塞30的后端具有与装置外壳28的后端共同协作的触发式促动器组件34，并且包括一杆部，该杆部纵向分开以形成一对在其侧面上具有倒转的扳机指58的触发臂38。该触发式促动器组件34用来克服压缩螺旋驱动弹簧36的力将柱塞30保持在回缩位置中。促动器组件34的触发臂38适用于用指尖按压以松开柱塞30，从而使之在弹簧作用下朝着前进位置行进，并且用于相应地将插入针头12以及与之一起行进的插管26经皮安置穿过病人的皮肤。在可选实施方案中，可以通过在装置外壳28的径向相对外侧区域上手动按压来使外壳变形28并由此松开触发臂38，从而使得柱塞30松开。
图1-5显示出注射器装置外壳28的结构细节，其中其下端或鼻部形成用于安置压靠在病人皮肤上的平坦且大体上为平面的周边表面25，并且该装置外壳28的纵向轴向大体上垂直于病人皮肤取向。该装置外壳28的中空孔具有用来容纳输液器14的尺寸和形状，并且插入针头12延伸穿过插管26并且沿着用于安置在病人上的方向与插管26一起延伸。可拆卸的盖板42(图1和2)优选在其鼻端处固定在装置外壳28上以指明该输液器14的无菌性。该装置外壳28还可以包括与插入针头12平行地延伸的狭槽(未示出)和纵向延伸的轨道槽52(图3)，所述狭槽用来滑动配合容纳从输液器外壳横向伸出的连接元件以使输液器与泵(未示出)连接。该柱塞30包括肋条50，用来受引导容纳在形成在装置外壳28中的轨道槽52内，从而控制柱塞30在前进位置和回缩位置之间的运动。该柱塞30的肋条50在头部32附近形成了一表面51，用来与在装置外壳28的鼻端处的周围内缘29共同协作以限制柱塞的运动，由此限定了柱塞30的前进位置。
因此，该装置外壳28的前端或鼻端容纳了皮下输液器14在基本上设置在装置外壳28的最后面的端部处的回缩位置和前进位置之间的运动。
如所理解的一样，触发式促动器组件34通常用来可拆卸地将柱塞30保持在回缩和准备位置中，从而准备在按压触发臂38时迅速地在弹簧作用下促动以将该输液器14安置在病人身上。更具体地说，触发组件34最初通过扳机指58锁定在形成在装置外壳28上的台肩66上。驱动弹簧36包括围绕着柱塞30上的杆部设置并且在柱塞头部32的后表面64和装置外壳28上的内台肩66′之间作用的盘簧。该驱动弹簧36通常朝着前进位置给该柱塞30施加偏压。在注射器装置组件的制造期间，在使柱塞30移动至回缩位置之前或之后，输液器14安放在形成在柱塞头部32中的凹槽中。在该回缩的柱塞位置中，驱动弹簧36保持在受压并且准备的状态中，并且输液器14的插管26容纳在插入针头12中。然后将可拆卸盖板52在其鼻端处施加在装置外壳28上。
在注射器装置10与输液器14的使用中，首先除去盖板42，并且将注射器装置10牢固地安置在病人皮肤上，并且输液器14以正确的取向并且在离皮肤预定间距的位置处受到支撑。将帽94去除，该帽通过防止接触触发臂38来防止输液器14不小心伸出。简单地按压臂38使得处于准备状态中的柱塞松开以便在弹簧作用下但是以受控的速度和力迅速行进，从而确保在产生最小的不适感的情况下并且以正确安置插入针头和插管26的方式刺透病人皮肤。
在安置好输液器14之后，可以从插管中方便迅速地将具有插入针头的注射器装置抽出。之后，可以扔掉该注射器装置，并且可以按照正常的方式使用该输液器14来通过输液管道和插管26给病人输送选定的药物。如图4所示，可以方便地采用安全帽94来与形成在柱塞30的头部32中的环形凹槽33共同操作来给针头12提供保护。
要注意的是，可拆卸帽94当在与柱塞头部相对的端部处密封在装置外壳28上时与盖板42一起使得注射器装置10与安装在插入针头12上的输液器14一起能够采用环氧乙烷在普通的消毒过程中进行消毒，在该情况中消毒剂流动穿过由盖板42形成薄膜。通过正确选择用于制造该注射器装置的材料，从而可以在正常存放条件下使该注射器装置保持无菌，从而不需要任何外部包装。
在图6-12示意性地显示出本发明的一可选实施方案，其中在功能上对应于前面参照图1-5所述的那些部件的部件由共同的参考标号加上100来表示。图6-12用来说明在该实施方案中所涉及的原理，并且这些附图显示出该注射器装置的示意性局部剖视图。
图6-12显示出一注射器装置组件，该组件包括由数量减少的零件构成的改进的注射器装置110并且具有用来使柱塞前进的可选驱动机构。该改进的注射器装置110包括一大体上为圆柱形的中空装置外壳128、一柱塞130和与该柱塞130形成为一体的触发式促动器134。优选为柔性薄膜的盖194覆盖着注射器装置110的顶部，并且另一个盖152盖着注射器装置110的底端。
柱塞130具有一大体上为圆柱形的形式，它具有一头部132和具有在模制过程中通过压配或通过任意其它方法固定在其上的金属插入针头112的一中央销129，从而对在该装置的使用过程中对插入针头的松开提供适当的阻力。该销129停止在离在头部132处的一对向外翻转的腿部138′一定距离处，以便容纳在柱塞130的头部132中的输液器114。该插入针头112以如参照图1-6所述一样的类似方式延伸穿过输液器114。通常长度为大约50cm至120cm并且与输液器114连接的输液器管道113卷紧在装置外壳128和柱塞130之间的环形空间115的上部。
更具体地说，装置外壳128还具有一向前端或鼻端，它限定了一平坦并且大体上为平面的表面125，用来牢固安置在病人皮肤上。柱塞130另外包括一对弹性触发臂138，它与一对向外翻转的腿部138′连接并且在其侧面处具有外翻的扳机指158。触发臂138用于并且其尺寸设定成在柱塞130从前进位置(图6)向回缩位置(图9)移动时在它们跨在该装置内时朝着彼此局部径向压缩。在到达回缩位置时，触发臂138通过弹性在弹簧作用下向内然后向外运动，由此扳机指接合着装置外壳128的台肩166的上表面。在该位置中扳机指158将柱塞130保持在回缩位置中。
驱动弹簧136安装在装置外壳128内，用来在触发臂138松开时朝着位于柱塞130的回缩位置中的装置外壳的鼻部驱动柱塞。该驱动弹簧136在模制过程中与装置外壳128和柱塞130形成为一体，并且一般可以由与柱塞130和装置外壳128相同的塑料材料形成。在图12更详细地显示出弹簧。该弹簧136在位于柱塞130和装置外壳128之间的环形空间115中基本上包括许多系统的塑料带136，每个围绕着柱塞130的周边的相应部分延伸。该图面显示出装有两个这种条带的实施方案，每个条带围绕着柱塞130的周边的大约1/4延伸。每个条带136在一个端部136″与柱塞连接成一体，并且在另一个端部136′与装置外壳128连接成一体。在图6-8和10-12中所示的柱塞的前进位置中，这些条带136优选基本上为平面并且没有变形。但是，当使柱塞130移动至在图9中所示的回缩位置时，弹簧的条带136弯曲，从而设定了用来朝着装置外壳128的鼻部驱动柱塞130所需要的力。要注意的是，该过程通常提高了柱塞130绕着其中央轴线的旋转运动，这与插入针头112一致。
在图6-12中所示的注射器装置组件的操作如下。由于注射器装置优选在非触发(uncocked)状态交付给病人以简化制造工艺，但是该柱塞130必须首先向回缩位置运动。为了使得柱塞130能够回缩，如图7所示，首先拆除跨过装置外壳128的上盖184和下盖142。下盖142可以铰接连接在装置外壳128。在该过程中，输液器114暴露出，并且插入针头112的尖端112A从柔性插管126的端部伸出。然后将输液器管道113连接在合适的泵上，并且通过使得药物能够通过在插管126和插入针头112之间的狭窄环形空间排出或者如图18所示一样如果采用了中空针头的话通过该针头排出，从而将输液器114准备好(在图8中的液滴300)。然后通过如图9中的箭头所示一样使柱塞130相对于装置外壳128移动来使注射器装置110准备好，直到手指158接合着装置外壳120的上台肩166，从而表示该注射器装置目前正准备使用。然后除去剥离片114′，从而暴露出在输液外壳114的底面上的粘性材料，然后病人或护理人员将注射器装置安放在病人皮肤上。通过在臂138上施加向内朝向的手动力来松开柱塞130，从而经皮安置插入针头112和插管126。在可选实施方案中，通过在装置外壳128的径向相对外侧表面上手动按压以使外壳128变形并且由此松开触发臂138来使柱塞130松开。
然后除去注射器装置110，从而将输液器114留在由参考标号116表示的病人皮肤上，然后将底盖142重新设定在图11中所示的原始位置中以保护从装置外壳128的鼻端部分伸出的插入针头112。
密封在装置外壳128上的可拆卸上盖194和底盖142使得注射器装置110可以与安装在插入针头112上的输液器14一起在普通的消毒过程中采用例如环氧乙烷消毒。为此，一个或两个盖142、194可以包括一渗透膜，从而使得消毒剂能够从中流过。通过选择适当的材料，从而可以使注射器装置在正常存放条件下长时间保持无菌，由此不需要任何其它包装来确保该组件在使用时的无菌性。为此，至少一个盖优选为上盖194可以带有与该组件的保存期相关的印刷指示。用于渗透膜的合适材料为TyvecTM。
图13-16显示出本发明的第三实施方案，其中在功能上与前面参照图1-5所述的那些部件相对应的部件由共同的参考标号加上200来表示。图13-16用来说明在该实施方案中所涉及的原理，并且这些图面显示出注射器装置210的示意性局部剖视图。该注射器装置210尤其适用于相对于病人皮肤成锐角安置皮下输液器214。
如在图13中可以最清楚地看出，该图显示出处于半开状态中的注射器装置，该注射器装置210具有一装置外壳228，它具有带有平行主壁224、219的扁平盒形结构，壁219包括易折断区域219″，参见图16，从而使得能够通过手动拉扯翼片229(图13)来撕开该壁219，由此为了将在下面所述的目的形成两个分开的壁部219′、219″。该外壳228还包括位于注射器装置的鼻端处一前壁227和后壁280以及可折断地连接在壁部219′上的相对平行侧壁225。以封闭的盒形物品形式将注射器装置210提供给消费者，该物品可以很容易按需要设有印刷文本。
图14显示出处于在图13中所示的相同状态中的注射器装置；但是，一部分壁224、227和219以及壁225已经删除以显示出注射器装置210的内部。
该注射器装置210包括安装用来在盒形外壳内在向后回缩位置(图14)和向前前进位置(图15)之间进行纵向滑动运动的柱塞230。该装置外壳228和柱塞230优选由塑料材料形成。或者该装置外壳228可以由刚性纸板坯料制成。柱塞230在其前端处具有一带凹槽的头部232(在图16中看得最清楚)，它成形用来容纳皮下输液器214得外壳。在该凹槽中的中央处，头部232设有固定连接在其上的伸出金属插入针头212。如在为拆除输液器提供阻力的意义上所能理解的一样柱塞230不必为输液器提供支撑。这种支撑优选由插入针头212和输液器214的摩擦接合来提供。设置在壁280后面的驱动弹簧236在柱塞头232的向后表面264之间作用。驱动弹簧236通常朝着前进位置向柱塞230施加偏压。柱塞230的前端具有与装置外壳28的壁224协同操作的触发按钮258。在图14中所示的柱塞的回缩状态中，如将在下面所述一样，触发按钮258延伸穿过形成在装置外壳228的上壁224中的开口222并且设置用来容纳在壁219′上的剥离翼片220。
触发按钮258可以用来用指尖按压以松开柱塞230，从而使之在弹簧作用下朝着前进位置行进，并且穿过病人皮肤相应地经皮安置插入针头212和与之一起行进的插管226。优选的是，通过使壁部219′绕着线227′转动来按钮按钮258。当形成在壁部219′的外表面上的翼片220与槽220对准时，可以通过向下手动按压壁部219′来按压触发按钮258以促动受到弹簧作用的柱塞。
在打开装置外壳210之前，即在沿着可折断线219″′分开壁219、219′之前，将该组件保持在无菌状态中。将可拆卸盖294(图13)密封在壁224上以盖着开口222。由于形成封闭外壳210的所有其它壁密封在一起，所以盖板294在可渗透时使得注射器装置210可以与安装在插入针头212上的输液器214一起在普通的消毒过程中采用例如环氧乙烷消毒，其中消毒剂流动穿过渗透膜。
图17显示出适用于根据本发明的注射器装置的输液器14的实施例。输液器14包括具有内部腔室(未示出)的外壳2。内部腔室利用输液管道113接收药物，该输液管道可以通过任意合适的连接器7可拆卸地连接在外壳3上。外壳3的基底24可以带有粘性材料并且设有一剥离片14′，将该剥离片去除以在安置输液器之前暴露出该粘性材料。输液器14具有伸出的柔软且有韧性的插管26，它与内部腔室连通。由密封薄膜4密封并且由注射器装置的插入针头穿过的内部通道延伸穿过与插管26相对的外壳。
图18显示出如何采用具有部分显示出的并且带有具有侧面开口12B、112B的中空插入针头12的柱塞的注射器装置在安置输液器之前进行输液装置的准备。在将输液器14安装在注射器装置上的适当位置中时，注射器装置的医用插入针头12、112延伸进入输液器14的内部腔室2，并且穿过插管26、126。然后通过管道113将药物6提供进内部腔室2。为了使得用户能够在视觉上确认内部腔室2已经完全充满药物，侧面开口12B、112B使得药物能够流进针12、112的内部并且通过尖端12A、112A排出。
对本发明的自动注射器装置单元的各种进一步的改变和改进对于本领域普通技术人员将是显而易见的。因此，上述说明和附图并不打算对本发明进行任何限制，本发明应该在所附权利要求中进行限定。要注意的是，根据设计该组件应该在不需要任何进一步的包装的情况下投放给市场。

Claims (28)

1.一种注射器装置(10，110，210)，用来穿过病人皮肤而经皮安置皮下输液器(14，114，214)的中空插管(26，126，226)，所述装置包括：
一装置外壳(28，128，228)；
一柱塞(30，130，230)，它可滑动地容纳在所述装置外壳(28，128，228)内以便在一前进位置和一回缩位置之间运动；
一驱动器，包括一个弹簧(36，136，236)，用于迫使柱塞(30，130，230)从回缩位置推向所述前进位置；
其特征在于，该柱塞(30，130，230)具有基本上不可拆却地固定在其上的插入针头(12，112，212)，用来将所述皮下输液器(14，114，214)的插管(26，126，226)容纳并且支撑在一个位置中，使插管取向成在柱塞(30，130，230)与所述针头(12，112，212)一起从所述回缩位置向所述前进位置运动时经皮安置，以便经皮安置容纳在所述插入针头(12，112，212)上的所述皮下输液器(14，114，214)的插管(26，126，226)，
其中固定在所述柱塞(30，130，230)上的所述插入针头(12，112，212)可以从所述插管(26，126，226)中拆除，同时使所述插管(26，126，226)保持经皮安置。
2.如权利要求1所述的注射器装置，其中所述装置外壳(28，128，228)具有一前端，其限定了一大体上为平面的表面(25，125，225)，用来在所述装置外壳(28，128，228)相对于病人皮肤成预定取向的情况下压靠在病人皮肤上而安置。
3.如权利要求1或2所述的注射器装置，其中与所述柱塞(30，130，230)相对的所述插入针头(12，112，212)的前端(12A，112A，212A)在所述柱塞(30，130，230)处于回缩位置时基本上回缩在装置外壳(28，128，228)内。
4.如权利要求1或2所述的注射器装置，其中所述输液器(14，114，214)包括一管道(113)，所述装置外壳(28，128，228)包括一空间，优选为一环形空间(115)，用来容纳所述管道(113)。
5.如权利要求1或2所述的注射器装置，还包括用来促动所述驱动器的触发器。
6.如权利要求5所述的注射器装置，其中所述触发器包括一触发促动器，用来用指尖按压以促动该驱动器以便使柱塞(30，130，230)从回缩位置运动至前进位置。
7.如权利要求5所述的注射器装置，其中所述触发器包括一锁紧件(58，158，258)，用来可拆卸地将所述柱塞(30，130，230)锁在所述回缩位置中。
8.如权利要求1或2所述的注射器装置，其中所述装置外壳(28，128，228)和所述柱塞(30，130，230)包括可协同接合的轨道部件，用来在所述前进和回缩位置之间引导所述柱塞(30，130，230)的运动。
9.如权利要求1或2所述的注射器装置，其中所述插入针头(12，112，212)基本上不能输送液体。
10.如权利要求1或2所述的注射器装置，其中所述柱塞(30，130，230)的头部(32，132，232)还包括用于将所述中空插管(26，126，226)保持在所述插入针头(12，112，212)上的安全保持器，该安全保持器使得插管(26，126，226)和所述插入针头(12，112，212)在柱塞(30，130，230)的头部处于前进位置中时能够分开。
11.如权利要求1或2所述的注射器装置，其中所述插管(26，126，226)是柔软且有韧性的。
12.如权利要求1或2所述的注射器装置，其中所述弹簧(136)包括位于柱塞(130)和装置外壳(128)之间的环形空间(115)中的许多单独细长的柔性塑料带，它们围绕着柱塞(130)的周边的相应部分延伸，每个条带与柱塞(130)和装置外壳(128)连接。
13.如权利要求12所述的注射器装置，其中所述条带与所述柱塞(130)和所述装置外壳(128)模制成一体。
14.如权利要求12所述的注射器装置，其中每个条带在一个端部(136′)处与所述柱塞(30，130，230)连接，并且在另一个端部(136″)处与所述装置外壳(28，128，228)连接，每个条带在柱塞(30，130，230)的前进位置中基本上为平面并且没有变形。
15.如权利要求1或2所述的注射器装置，所述装置外壳包括一扁平盒形结构。
16.如权利要求1或2所述的注射器装置，其中所述插入针头(12，112，212)是中空的，并且在所述柱塞(30，130，230)附近具有一侧面开口(12B，112B)。
17.一种注射器装置组件，包括：
一输液器(14，114，214)，它包括一外壳和一中空插管(26，126，226)；和
根据权利要求1-16任一项所述的注射器装置，所述输液器(14，114，214)被所述插入针头(12，112，212)容纳和支撑。
18.如权利要求17所述的注射器装置组件，其中所述输液器(14，114，214)包括用于给所述中空插管(26，126，226)输送药物的管道(113)，所述空间，优选为环形空间(115)，用来容纳所述管道(113)。
19.如权利要求17或18所述的注射器装置组件，其中一可拆卸盖部件(94，194，227，42，142)盖着所述装置外壳(28，128，228)的至少一个端部，用于在使用该注射器装置组件之前确保了所述输液器(14，114，214)的无菌状态。
20.如权利要求19所述的注射器装置组件，其中在所述盖部件(94，194，227，42，142)上印刷有与该组件的保存期相关的指示。
21.如权利要求17或18所述的注射器装置组件，还包括位于所述装置外壳(28，128，228)的前端处的盖(42，142，227)，用来盖着容纳在所述插入针头(12，112，212)上的输液器(14，114，214)并且用来在除去所述输液器(14，114，214)之后盖住所述插入针头(12，112，212)。
22.一种注射器装置，包括：
一模制装置外壳；
一模制柱塞，它可滑动地容纳在所述装置外壳内用于在一前进位置和一回缩位置之间运动；
一驱动器，用来从所述回缩位置朝着所述前进位置推压所述柱塞；
其中所述驱动器包括多个单独细长的柔性塑料部件(136)，每个部件与所述柱塞和所述装置外壳连接。
23.如权利要求22所述的注射器装置，其中每个所述细长柔性塑料部件在一个端部(136′)处与所述柱塞连接，并且在另一个端部(136″)处与所述装置外壳连接，每个部件在所述柱塞的前进位置中基本上为平面并且没有变形。
24.如权利要求22或23所述的注射器装置，其中每个部件(136)成形为一条带，所述装置包括至少两个这种条带，每个条带围绕着所述柱塞(30，130，230)周边的相应部分延伸。
25.如权利要求22或23所述的注射器装置，其中每个所述部件(137)在位于所述柱塞(30，130，230)和所述装置外壳(28，128，228)之间的环形空间中延伸。
26.如权利要求22或23所述的注射器装置，用于穿过病人皮肤经皮安置皮下输液器的插入针头，其中所述柱塞包括一支撑结构，用于将所述输液器容纳并且支撑在一个位置中，使其插入针头取向成在柱塞从所述回缩位置向所述前进位置运动时经皮安置，其中所述支撑结构可以从输液器去除，同时使插入针头保持经皮安置。
27.如权利要求22或23所述的注射器装置，利用插入针头穿过病人皮肤经皮安置皮下输液器，其中所述插入针头基本上不可拆卸地固定在所述柱塞上，并且其中所述插入针头将所述输液器的插管容纳并且支撑在一个位置中，使该插管取向成在所述柱塞从所述回缩位置向所述前进位置运动时经皮安置，其中所述插入针头可以从输液器去除，同时使插管保持经皮安置。
28.如权利要求22或23所述的注射器装置，其中，每个所述单独细长的柔性塑料部件(136)与所述柱塞和所述装置外壳模制成一体。
CNB028188772A 2001-09-27 2002-09-27 用于安置皮下输液器的注射器装置 Expired - Lifetime CN100406075C (zh)

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