CN101500627B - 套管和输送装置 - Google Patents

套管和输送装置 Download PDF

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CN101500627B
CN101500627B CN2007800289081A CN200780028908A CN101500627B CN 101500627 B CN101500627 B CN 101500627B CN 2007800289081 A CN2007800289081 A CN 2007800289081A CN 200780028908 A CN200780028908 A CN 200780028908A CN 101500627 B CN101500627 B CN 101500627B
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S·吉尔恩
O·马塞厄森
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Abstract

本发明涉及一种用于安装在基部(9)中的套管装置，其包括一起限定至少一个腔体的壳体(1a、1b)和至少一个膜(4)，所述套管装置还包括安装在壳体中、并且与所述至少一个腔体流体连通的套管(3)，所述套管装置在套管装置的近侧上设有用于将套管装置附装至基部(9)的装置(5)。

Description

套管和输送装置
技术领域
本发明涉及一种用于在输送装置等中使用的套管装置以及一种用于***该套管装置的***装置。
背景技术
用于间断或连续地供给诸如胰岛素的治疗物质的输送装置经常具有两部分的装置的形式。这种传统的输送装置包括基部，该基部具有用于皮下***患者的套管并且包括用于将基部固定到患者皮肤的装置，此外该基部具有用于关闭到基部的流体通路的装置，并具有用于打开流体通路的装置，例如用于接收从连接器部件伸出的连接器套管并且用于使该连接器套管与基部的套管流体连通。经常，连接器套管与诸如胰岛素泵的药物输送装置流体连通。
在WO 02/068041A2、EP 0956879A1、US 5522803、US2003/0225373A1和WO 03/026728A1中描述了不同类型的输送装置。
US 2003/0176852A1公开了一种输送装置，其中基部包括枢转构件，包括枢转构件和用于***患者的套管的所述基部具有内部腔体，所述内部腔体具有适于接收***针头或连接器套管的一个接收端部和用于进一步与基部的套管连接的两个连接端部(316I和320)。在***期间，枢转构件定位成与基部相互垂直，并且***针头刺穿接收端部中的膜，并且针头通过管道并通过第一连接端部而进入套管中，所述套管然后可以被***。***之后，针头被去除并且枢转构件与连接器连接。连接器和枢转构件从与该枢转构件和***器之间的连接相同的方向连接。枢转构件然后转动以便使第二连接端部与套管对准。该装置具有以下缺点：由于较小的调节就将封闭药物的输送，所以对枢转构件的运动非常敏感。
WO 02/094352A2公开一种输送装置，该输送装置在基部中具有能够接收来自一个方向的***针头和来自第二方向的连接器针头的结构。该设计不允许患者选择他/她期望使连接器与基部连接的方向。
在这些现有技术的输送装置中，套管的结构和用于在套管与来自连接器的套管之间提供流体连通的装置对于每个套件是独特的。通常，每个输注套件还利用特定的引导和/或锁定装置套件，由此仅允许特定连接器与基部接合。
WO 06/015600A1公开一种具有通用部件的输送装置，该通用部件具有套管和适于接收来自连接器的套管的装置，并且该通用部件配合到大多数/所有的可用的普通输注套件。该设计允许不同类型的连接器与相同的基部一起使用且反之亦然，而且也能够从不同的角度连接连接器。
US 2004/0158207涉及一种用于将套管***组织中的装置，其包括套管、可以容纳所述套管的保护元件、用于使套管移出保护元件的操作元件和固定地连接至套管的夹持器。该公开文献还包括连接液体供应器至套管的***。
发明内容
本发明的目的是提供一种套管装置，所述套管装置能够用作不同类型的输送装置中的部件并且在基部已经施加至患者的皮肤之后应用。
根据本发明，提供一种用于安装在基部中的套管装置，所述套管装置包括一起限定至少一个腔体的壳体和至少一个膜，该套管装置还包括安装在所述壳体中、并且与所述至少一个腔体流体连通的套管，所述套管装置在所述套管装置的近侧上设有用于将所述套管装置附装至基部的装置。
这种套管装置的优点是其可以在输送装置中用作标准部件，不管该输送装置倾斜还是竖直***套管。因而该标准部件可以大量生产并且可以用作在期望设计的输送装置系列中的部件。这样导致更低的生产成本、更灵活的生产线以及更灵活的产品。在近侧(即，在安装套管装置之后转向患者的一侧)上定位附装装置使得更容易通过***来正确定位套管装置，因为能够用手柄或***装置覆盖或连接套管装置的侧部。因而附装装置将确保附装至基部或接收部分，同时附装装置的侧部将确保适应于***装置。
在另一实施例中用于安装在基部中的套管装置包括一起限定至少一个腔体的壳体和至少一个膜，该套管装置还包括安装在所述壳体中、并且与所述至少一个腔体流体连通的套管，其中套管装置设有用于将所述套管装置不可释放地附装至基部(即，至基部的特定适合的接收部分)的装置。
因为套管与患者的血液接触，所以套管装置通常是使用后扔掉的一次性的装置。如果附装套管装置的基部也是具有大约相同工作寿命的一次性的装置，则不必能够从基部去除该装置，因为套管装置和基部二者通常在使用几天之后被去除和处置。当不能从基部去除套管装置时，不能将使用过的套管装置与新的无菌套管装置混淆，并且锁定有套管装置的基部的接收部分同样明显不适合使用。
如果基部是可以附装至患者更长时期的类型，则其能够在不同的位置处***新的套管装置，而使用过的套管装置从皮下位置去除，即，通过与可以永久附装套管装置的接收部分或接收部分的一部分一起去除该套管装置。
两个实施例都具有以下优点：能够使使用者首先仔细定位基部，并在已经适当定位该基部之后，使用者能够全神贯注地注射套管装置。
在一个实施例中，用于将所述套管装置附装至基部的装置包括与基部上的相对应的装置协同操作的机械特征部，即，用于将所述套管装置附装至基部的装置包括从套管装置的近表面伸出的部件，所述部件能够枢转并由此在至少一个位置中暂时地减小直径，或者用于将所述套管装置附装至基部的装置可以包括位于套管装置的近表面上的粘接至基部的相对应表面的粘接表面。
在一个实施例中，套管装置设有与***装置相对应的引导装置，当通过***装置而向着基部运动时，所述引导装置确保套管装置的精确限定的运动。
在一个实施例中，套管装置利用***装置***，该***装置设有覆盖所述套管装置的全部长度的覆盖部件。
在一个实施例中，所述套管装置的本体中具有最大直径的部分绕中心轴线旋转对称。
在另一实施例中，套管装置的本体中具有最大直径的一部分具有有角的侧部，例如当剖开时设有三角形或四边形型面。当具有有角的侧部时，套管装置的型面可以用于限定正确的***位置。
在一个实施例中，套管装置包括呈现平滑外表面、并具有内部腔体的本体，该内部腔体在远端处由诸如膜或隔膜的壁覆盖，所述壁可以被诸如连接器针头或注射器的针头刺穿，并且在内部腔体的近端处嵌入有套管，本体的外部近表面，即，在注射套管装置期间面朝接收部分的本体的表面设有用于将套管装置不可释放地附装至接收部分的装置。平滑的外表面能够具有例如圆形的或椭圆形的周边，并且覆盖内部腔体的远端的壁能由尖的针头或可能优选的钝的针头刺穿。
在一个实施例中，当套管装置被推靠在接收部分上时，自动地形成接收部分和套管装置之间的不可释放的附装，即，不需要采用任何动作就形成不可释放的附装。
根据本发明的另一方面，提供一种输送装置。该输送装置包括设有用于套管装置的接收部分的基部，其中接收部分具有用于***装置的引导装置，所述***装置在***之前支持套管装置，即，因为用于***装置的引导装置可以提供足够的引导来正确定位套管装置，所以接收部分没有用于套管装置的引导装置或至少接收部分不需要用于套管装置的引导装置。
在一个实施例中，套管装置与***器的一部分中的内部开口相对应，并且套管装置设有用于将套管装置附装至在套管装置本体的近端上的基部的装置。
附图说明
将参照附图进一步详细说明该套管装置。
图1A是本发明的套管装置的实施例的视图，B是与图A所示的套管装置相同的套管装置的剖视图，C是具有正方形型面的套管装置沿着图1B的线A-A得到的截面图，D示出具有正方形型面、从不同角度进入位置的套管装置；
图2是布置在输送装置的接收部分中的本发明的套管装置的实施例的剖视图；
图3是具有在中心的接收部分的基部的俯视图；
图4是具有在中心的接收部分的基部和定位在接收部分中且具有圆形型面的套管装置的俯视图；
图5是具有在中心的接收部分的基部和定位在接收部分中且具有正方形型面的套管装置的俯视图；
图6是其上已经安装顶部的基部的俯视图，所述顶部包括贮液器和用于运输该贮液器的容纳物至患者的装置；
图7是图5所示的输送装置的剖视图；
图8是根据本发明的输送装置的另一实施例的剖视图；
图9示出具有用于圆形套管装置的松配合正方形接收部分的基部的实施例；
图10示出具有用于正方形套管装置的紧配合正方形接收部分的基部的实施例；
图10A示出具有用于正方形套管装置的紧配合正方形接收部分的基部的实施例，所述套管装置具有两个进口；
图11示出具有接收部分而没有用于任一套管装置的竖立壁的基部的实施例；
图12示出具有用于未示出的套管装置的正方形接收部分的基部的实施例；
图13是示出安装在准备用于注射的***器中的套管装置的侧视图；
图14示出根据本发明安装在***器中的套管的相同实施例的两个视图，所述***器结合到基部的接收部分；
图15是本发明的***装置的第一实施例的剖视图，其中所述***装置安装在接收器中并且***针头处在致动之前的退回位置中；
图16是处在致动***装置并***套管之后的位置中的图15的实施例的剖视图；
图17是图15所示实施例的***装置在安装在接收器中之前的侧视图；
图18是本发明的***装置的另一实施例的剖视图，其中所述***装置安装在接收器中并且***针头处在致动之前的退回位置中；
图19是处在致动***装置并***套管之后的位置中的图18的实施例的剖视图；
图20是图18中的实施例的***装置的侧视图，其中第一***部件和第二***部件被组装；
图21是图18中的实施例的***装置的侧视图，其中第一***部件从第二***部件拆卸；
图22是图18中的实施例的***装置的第一***部件的侧视图；
图23是图18中的实施例的***装置的第一***部件的另一侧视图；
图24是图18中的实施例的***装置的侧视图，其中第一***部件布置在第二***部件中；
图25是图24中的实施例的***装置的侧视图，其中第一***部件旋转到右边；
图26是图24中的实施例的***装置的侧视图，其中***装置处在准备好致动和***套管的位置中；
图27是图24中的实施例的***装置的侧视图，其中***装置安装在接收器中，准备***；
图28是图24中的实施例的***装置的侧视图，其中致动***装置并执行套管的***；
图29是图24中的实施例的***装置的侧视图，其中***装置处在致动并***套管之后的位置中，并且***针头处在退回位置中；
图30是图24中的实施例的***装置的第一***部件的侧视图，其中第一***部件从第二***部件去除以进行处置。
具体实施方式
图1A和B示出本发明的第一实施例。在该实施例中，套管装置包括一起限定内部腔体的壳体1a、1b和例如膜4形式的壁，所述内部腔体适于接收从例如连接器或注射器伸出的刺穿构件6。壳体1a、1b通常由较硬的模制塑性材料制成。
下部件1b可以由圆柱形上部和具有较小直径的圆柱形下部构造，在所述上部处内表面形成内部腔体的壁并且外表面是平滑的且没有凸起，在所述下部处内表面形成支撑套管3的开口并且外表面包括用于将套管装置不可释放地附装至基部9的装置。
套管装置还可以构造具有有角的型面，例如，如图1C所示的四边形型面。该图示出套管装置的两个实施例：具有圆形型面的装置(上)和具有正方形型面的装置(下)。如果沿着图2所示的线A-A从上方看套管装置时将示出该型面。不管套管装置的型面是圆形的还是有角的，其可以在接收部分中具有松配合或紧配合，其中松配合的意思是：接收部分设有用于***器的引导装置，并且当***器根据导向装置布置时以及当***器从接收部分去除时该套管装置设置在正确位置中，将绕着套管装置出现与***器的壁相对应的空的空间。紧配合的意思是：基部的接收部分设有与套管装置的形状或型面紧密对应的空间，并且***器将套管装置定位在具有与套管装置的外壁紧密对应的壁的空间中。
图1D所示的套管装置具有用一个膜4覆盖的两个通路开口，在另一实施例(未示出)中每个通路开口能够在不同的表面位置处(例如，分别是4a和4b)用分开的非连接的膜覆盖。该套管装置能够经由表面4a或表面4b从两个不同的角度供应药物。如果相对应的开口设置在接收部分7中或者套管装置能够是用于两种不同类型的基部9(其在接收部分7中具有不同的开口)的标准件，则这种装置提供具有用于药物的额外通路的可能性。
套管装置由软的惰性物质制成，并且在该实施例中，在圆柱形下部件的开口中定位套管3之后该套管3通过将固定部件2推入该开口中而附装至壳体1b，所述固定部件2由比套管3更刚性的材料制成。在固定部件2推入到开口中时，套管3将靠着开口的壁被挤压并且该压力将使套管3保持在正确位置中。
用于将套管装置不可释放地附装至基部9的装置5在该实施例中构造成若干钩部5；这些钩部5可以绕着附装至壳体1a的位置枢转，在该实施例中用于钩部5的附件由柔性材料构成，即，当钩部5通过减小的直径的区域时可以将钩部向内推。每个钩部5都设有与基部9的接收部分7的接触表面7b平行的上表面5a。每个钩部5还设有倾斜表面5b，所述倾斜表面5b在***套管装置期间与接收部分7的凸出部件7a接触。当套管装置向下推入到接收部分7中时，钩部5被向内推靠着壳体1b的圆柱形下部件，并且在处于该位置的钩部5被偏压的情况下，当钩部5的倾斜表面5b已经完全通过接收部分7的凸出部件7a时钩部5将回到它们的原始位置。当钩部5回到它们的原始位置时，由于套管装置和接收部分7二者都未设有将钩部5向内推靠在壳体1b的圆柱形下部件上的装置，钩部的上表面5a将与接收部分7的接触表面7b碰触并且套管装置将锁定在该位置中。
根据未示出的另一实施例，凸出部件7a的上侧或壳体1b的下侧设有粘接剂，当套管装置推入到接收部分7中的合适位置中时所述粘接剂用作不可释放地附装的装置。
图2示出与图1相同的套管装置的实施例，其中套管装置定位在接收部分7中。接收部分7设有基本竖直定位的壁和由凸出部件7a形成的底部部件，所述壁覆盖套管装置的侧部，当套管装置锁定在接收部分7中时该套管装置布置在所述凸出部件7a上。绕套管装置的空间8产生用于***器的引导装置，所述空间8具有在基本竖直壁和套管装置的侧部之间的圆柱形空间形式。套管装置在该实施例中通常被***器的圆柱形下部件完全覆盖，并且当使用者想要注射套管装置时该***器的圆柱形下部件布置在由接收部分7形成的空间8中，然后通过柱塞在***器的圆柱形下部件的内部向前运动而推动套管装置就位。
接收部分7不可释放地附装至基部9，所述基部9通过例如安装垫10固定到患者的皮肤。
图3示出设有接收部分7并设有用于输送部件12的附装部件11的基部9的上部视图。
图4示出与图3相同的基部9的上部视图，所述基部9也设有接收部分7并设有用于输送部件12的附装部件11，但是在图4中套管装置已经定位在接收部分7中。
图5示出基部9的另一实施例的上部视图。该基部9的接收部分7具有正方形内部空间，并且具有外部正方形型面的套管装置1a布置在接收部分7中。
图6示出如图3、4或5所示的基部9的上部视图，但是在图6中基部9已经设有盖12，在该盖12中嵌入用于药物的贮液器13和用于从该贮液器运输药物至患者的装置。
图7示出图6所示装置的剖视图。图7示出定位在基部9上的接收部分7，所述基部9具有在下面的安装垫10。套管装置已经***接收部分7中并且套管装置的套管3皮下***患者中。套管装置和接收部分可以是正方形或圆形的。盖12已经安装在基部9上，并且连接器针头6通过刺穿套管装置的隔膜4而在附装至盖12内部的贮液器13与套管装置之间形成流体连接。
图7的输送装置可以通过以下步骤安装在患者上：
IV.拆开无菌基部9并将其固定到患者的皮肤；
V.拆开包括***装置的无菌单次使用***器，或拆开包括与套管装置结合的注射针头的无菌部分并将其施加到多次使用的***器，***器的近端布置在接收部分7的引导装置8中并***套管装置，即，皮下注射套管3。
VI.包括盖12、贮液器13和用于运输贮液器的容纳物至患者的装置在内的输送部件被固定到基部9，并且当盖12固定到基部9时连接器针头6刺穿套管装置的隔膜4，于是输送装置准备好工作。
图8示出输送装置的另一实施例。在该实施例中，接收部分7定位在基部9的边缘，并且具有圆柱形本体1b的套管装置没有与患者的皮肤垂直而是以大约30°的角***。附图标记参照图6和7中的类似的部件。
图9和10示出输送装置的其它实施例。图9的实施例设有布置在正方形或矩形接收部分7中的圆柱形套管装置(圆形型面)。该实施例提供用于套管装置的松配合。图10的实施例设有布置在正方形或矩形接收部分7中的正方形或矩形套管装置。该实施例也提供用于套管装置的松配合，其中接收部分7的竖立壁能够提供用于***器的引导装置。图10a示出图10的实施例如何能够适应于具有覆盖进口4a和4b的膜的套管装置。
图11示出在中心布置的、没有引导***器就位的竖立壁的接收部分7。代替地，在***套管装置1期间，与***器的近端的一部分对应的基部9的中心板9a的稍微升高的周边指示***器的正确位置。
图12示出具有在中心布置的接收部分7的基部9，所述接收部分7具有竖立壁，所述壁使接收部分7具有正方形型面。示出在***套管装置1之前的基部9。
图13和14示出当在具有图3-10所示接收部分7的输送装置中***套管装置时可以使用的***器。这种***器应该具有提供与部件(例如，接收部分7的壁)相对应的型面的外壁和提供与所述的套管装置相对应的型面的内壁，以便使***器引导套管装置到正确位置中。
为了使***器14与基部9的接收部分7适当地相互作用，期望***器14设有超出***器的注射针头的端部延伸的引导装置15。引导装置15可以具有三重目的，它们可以用于：1)在注射套管装置之前、期间或之后，保持注射针头在使用者不能看见的地方；2)保护环境免受注射针头影响，以及3)确保套管装置安全和精确注射到接收部分7中。
在该实施例中，***器的引导装置15具有与接收部分7中的引导装置8(参见例如图2)的形状相对应的形式，例如是圆柱形或矩形的管的形式。
图15和30所示的特定***器的更详细说明以及该***器如何能够起作用可以在2006年8月2日提交的DK申请no.PA200601028中找到。
图15和16示出***装置更详细的视图，且在图15中***装置处在其准备致动但还没有致动的位置中，并且在图16中***装置处在致动之后并在***套管装置之后的位置中。图15和16中的***装置的实施例包括第一***部件和第二***部件16形式的引导装置，该第一***部件15经由形式为在狭缝18中滑动的栓子(tap)17的引导装置而可滑动地安装在第二***部件16内部，该***装置还包括针头支持部件19，所述针头支持部件19包括注射针头6和弹性元件21，所述弹性元件21在该实施例中在***套管装置之后使注射针头6退回。注射针头6以这种方式结合到套管装置：当***装置致动时，套管3皮下***到患者的皮肤中。在所示的实施例中注射针头6布置在中空的套管3中。弹性元件21分别布置在第二***部件16的内部向下顶表面上和第一***部件15的内部向上表面上，并且当该弹性元件21被偏压时推动两个部件远离彼此。在图15和16中弹性元件21未被偏压。
在该实施例中，***装置在其致动之前定位在基部9上的接收部分7中。在基部9上，***装置可释放地连接至安装在基部9上的接收部分7，并且套管装置的钩部5可以与接收部分7中形成的接触表面7b接合，并由此将套管装置锁定到基部9。基部9通过例如粘接层固定到患者的皮肤。
图15和16所示的***装置的实施例用于单次使用整个***装置。该实施例使得能够首先在患者的皮肤上仔细定位例如包括接收部分7的基板9，其次通过在接收部分7中定位***装置而***套管装置，第三从接收部分7去除***装置并处置包括使用过的注射针头6的***装置。根据该实施例，注射针头6从未被使用者看到并且同时第一***部件15保护周围环境免受尖的且可能被感染的注射针头6的伤害。
图15和16的***装置的实施例是两部分的单元，所述两个单元经由弹性元件21(弹簧)相互作用；每个单元都可由模制本体构成。第一单元由第一***部件(即，引导装置15)构成，并且第二单元由第二***部件16构成，并且两个部件的外壁形成为圆柱形管。第一***部件15在第二***部件16的内部滑动，并且第二***部件16设有中心柱塞部件，所述中心柱塞部件包括在第一***部件15的内部滑动的针头支持部件19。这些管可以具有例如椭圆形或诸如六边形或八边形的多边形的任一横截面形式，或是只要第一***部件15可以沿着第二***部件16的纵向轴线运动的其它形式。在输送中该单次使用的***装置可以结合到接收部件7或可以单独包装。如果单次使用的设备结合到接收部件7，则使用者首先在患者的皮肤上定位基板9，然后使用者通过使第二***部件16从第一***部件15解锁而致动***装置并继而朝患者的皮肤推第二***部件16。如果单次使用的***装置单独包装，则使用者首先选择具有接收部分7的基板9，然后在患者的皮肤上定位该基板9，然后使用者拆开***装置并在基板上的接收部分7中布置该***装置。最后，使用者将套管装置1b注射到接收部分7中，从基板9去除***装置，相对于彼此锁定第一***部件15和第二***部件16以便保护周围环境免受污染的***针头的影响并以安全的方式处置用完的***装置。
第二***部件16可释放地固定到套管装置1b并且不可释放地固定到针头支持部件19，该针头支持部件19承载用于刺入患者皮肤的注射针头6。在该实施例中，弹性元件21以螺旋金属弹簧作为例子，但是弹性元件21可以是例如橡胶圆柱体或类似物的任一形式，所述弹性元件21可以定位在两个***部件15和16之间并在两个部件之间提供期望的作用。当***装置处在其达到如图15和16所示的致动之前或致动之后的位置中时，弹性元件21未被偏压，并且当***装置通过手动向下加压第二***部件16至用于***套管装置的前进位置中而被致动时，只要第二***装置16处在前进位置中弹性元件21就被偏压。
如图17详细示出，第一***部件15的外部表面设有形成为从第一***部件15的外表面凸出的圆柱形栓子17的凸起。栓子17与第二***部件16中的、具有狭缝18的形式的开口相互作用，所述狭缝18的形状形成有三个部件18a、18b和18c，其中第一部件18a具有沿着第二***部件16的纵向轴线的方向，第二部件18b与第二***部件16的纵向轴线垂直，并且第三部件18c也具有沿着第二***部件16的纵向轴线的方向。第三部件18c连接至第二部件18b，与第二部件18b和第一部件18a之间的连接相对。当第一***部件15的栓子17布置在狭缝18中的锁定位置中时，则栓子17定位在狭缝18的第三部件18c中并且弹簧21未被偏压或稍微被偏压，并且***部分15和16相对于彼此锁定。当使用者需要致动装置时，第二***部件16被稍微向下推直到栓子17碰撞狭缝的第二部件18b的上壁并且使用者感到不能进一步向下推动第二***部件16为止，这时栓子17与狭缝8的第二部件18b相齐平。使用者然后向右转动第二***部件16直到栓子17碰撞狭缝18的第一部件18a的右壁并且使用者再次感到不能再进一步转动第二***部件16为止，这时***装置准备好用于致动。
图18和19所示的***装置的实施例用于多次使用。图18示出***装置处在***之前还没有致动的位置中，并且图19示出***装置处在致动之后位置中，在该位置处套管3已经***并且注射针头6已经拉回到起始位置。
根据图18和19的实施例的注射装置(类似第一实施例)包括如第一实施例所述的彼此类似安装的第一***部件15和第二***部件16。套管装置1b连接至针头支持部件19，所述针头支持部件19设有注射针头6。在该实施例中，针头支持部件19是分开的单元，即，针头支持部件19通过例如舌部和槽部连接19a、19b而可释放地固定到第二***部件16，其中凸出部19a延伸到槽部19b中。如果针头支持部件19与第一***部件15一起转到左边，则舌部19a将从槽部19b释放并且针头支持部件19能够从由第一***部件15的外壁覆盖的第二***部件16去除。通常，针头支持部件19是可运动的，但不可释放地连接至第一***部件15。在图18和19中，***装置可释放地布置在基部9上的接收部分7中。
图20和21详细示出本发明用于多次使用的两单元***装置的相互连接。第一***部件15类似图15-17的实施例，设有在外部表面或外表面上形成为圆柱形栓子、并能够在狭缝18中运动的凸起17。如单次使用的实施例所述，狭缝18包括第一部件18a、第二部件18b和第三部件18c三个阶梯形部件。图20和21的多次使用的实施例与单次使用的实施例的不同在于：狭缝8的第三部件18c在第二***部件16的圆柱形壁中形成开口，并且该开口使栓子17能够离开狭缝18；较短的第三部件8a由此提供用于从第二***部件16结合或释放第一***部件15的装置。
当组装***装置时，第一***部件15的栓子17定位在狭缝8的开口的第三部件18c中并被向上推动，直到该栓子17到达狭缝8的横向的第二部件18b为止。然后第二***部件16旋转，直到栓子17定位在狭缝8的横向的第二部件18b的中间区域为止，由此布置第一和第二***部件就位，在该位置处防止第一***部件15相对于第二***部件16纵向运动。弹性元件21在该位置中未被偏压或仅稍微被偏压，且装置准备好使用。
同样地，两单元的***装置可以通过反向旋转第二***部件16而拆卸，由此使栓子17从狭缝8的横向的第二部件18b运动到狭缝8的第三部件18c中，并在栓子17经由第三部件18c的开口端部离开时拉动第二***部件16离开第一***部件15，由此从第二***部件16释放包括针头支持部件19的第一***部件15。
该实施例能够仅去除和处置包括针头支持部件19和使用过的注射针头6的第一***部件15。该特征提供第二***部件16和新替换的第一***部件15一起重复使用的可能性，所述新替换的第一***部件15包含新的注射针头6。此外，该实施例使第一***部件15能够在致动用于***套管装置的***装置之前或之后两种情况下构成针头保护装置。
图22和23二者详细示出多次使用的实施例的第一***部件15。图22示出包括与第二***部件16的狭缝18接合的栓子17的***部件15的侧部，图23示出包括具有定位在针头支持部件19上的凸出栓子23形式的装置的第一***部件15的相对侧部，所述栓子23与基本L形狭缝24接合，用于在***之前或之后使针头支持部件19锁定或解锁。针头支持部件19包括注射针头6(未示出)并且可释放地固定到套管1b。
图24、25和26示出在用于多次使用的***装置中安装可替换的第一***部件15的步骤。图27、28和29示出在将套管装置***基部9期间处在不同位置处的***装置。
图24示出一次性的第一***部件15如何布置在可再次使用的第二***部件16中。第一***部件15通过使用栓子17而被引导到狭缝8的第三部件18c中。当栓子17布置在狭缝8的横向的第二部件18b中时，如图25所示，第一***部件15相对于***装置的第二***部件16沿着纵向方向固定在锁定位置中。
针头支持部件19的凸出栓子23与第一***部件15的壁中的狭缝24接合，并且在将第一***部件15定位到第二***部件16中期间，凸出栓子23布置在L形狭缝24的一部分中，因为狭缝24的定位栓子23的该部分仅允许与纵向方向垂直的运动，所以在该部分处不能相对于第一***部件15进行沿着纵向方向的运动，即，栓子23确保针头支持部件19处在锁定位置中，并且注射针头6因此被锁定在第一***部件15内部并对于患者保持是安全的和隐蔽的。
在图25中，第一***部件15的栓子17朝右边旋转由此使栓子17运动到狭缝18的横向的第二部件18b中。针头支持部件19的栓子23由于第一***部件15的旋转而同时地被推入到L形狭缝24的短部件中，在该短部件处针头支持部件19不能沿着纵向方向运动。弹性元件21在该位置处未被偏压。
图26示出栓子17在第一***部件15的旋转右终点处的布置。在完全旋转***部件1之后，栓子17已到达狭缝18的第一部件18a与横向的第二部件18b之间的拐角，并且第一***部件15不能相对于第二***部件16进一步旋转。针头支持部件19的栓子23在旋转第一***部件15期间同时运动到基本L形狭缝24的拐角中，使针头支持部件19相对于纵向方向留在解锁位置中。弹性元件21仍然处在未偏压位置中。于是，***装置留在准备好致动和***与套管装置的套管3相结合的***针头6的位置中。
图27示出处在准备好致动和***套管4的位置中、与图24-26相同的***装置，并且***装置安装在基部9上的接收部分7中。
图28示出当完全致动，即，与套管装置的套管3结合的***针头6完全***患者的皮肤的皮下层中时的***装置。在***期间，第二***部件16朝患者的皮肤手动向下加压，由此偏压弹性元件21，因此在栓子17处在解锁位置中时第一***部件15向上滑动到第二***部件16的内部空间中。手动压力将使栓子17由第二***部件16的狭缝18的第一部件18a引导着向上滑动，并且栓子23将在第一***部件15的纵向狭缝24中向上滑动，通过这样注射针头6和套管3离开第一***部件15。当注射针头6离开第一***部件15时刺入患者的皮肤并且皮下***套管3。套管装置与基部9上的接收部分7接合，确保套管装置固定到接收部分7。
图28示出处在***针头6已经完全皮下***患者的位置中的***装置。在第二***部件16上的手动压力已经至少被部分地释放并且弹性元件21在回到未偏压位置的中途，该回到未偏压位置使栓子17在狭缝18的第一部件18a中朝横向的第二部件18b向下运动，并使第一***部件15的栓子23在狭缝24中沿着与第一***部件15的纵向轴线平行的方向向上运动。因此，弹性元件21使固定到针头支持部件19的第二***部件16退回，由此从套管装置释放注射针头6并使套管3留在患者体内。
为了达到图29所示的状态，从第二***部件16完全释放压力。此后，第二***部件16旋转到左边，使得栓子17运动到狭缝18的横向的第二部件18b的中间部。该旋转同时使栓子23运动到与纵向方向基本垂直的L形狭缝24的短部件中，由此既使第一***部件15锁定到第二***部件16又使针头支持部件9锁定在第一***部件15内部。***装置然后可以安全地从接收部分7去除，而注射针头6保持在第一***部件15的内部被保护并且不被患者看到。
图30示出在使用后已经从第二***部件16去除的第一***部件1。包含使用过并安全隐藏的注射针头6的第一***部件15已经从第二***部件16去除并且准备处置。针头支持部件19经由L形狭缝24中的栓子23锁定在第一***部件1的内部，由此当处置时，由于安全的原因而将使用过的***针头6保持在第一***部件15内。
根据本发明的套管装置能够适当地用在糖尿病治疗或其它药物的输送中，其中套管装置连接至贮液器和泵单元，或者套管装置可以是通路***的一部分，其中注射器可以用于供给患者一种或多种不同的药物。
根据本发明的套管装置还可以包括传感器或探测器，所述传感器或探测器必须具有皮下定位与患者的血流接触的部件，即便于测量患者血液的葡萄糖含量。

Claims (9)

1.一种套管装置，所述套管装置能够安装在基部(9)中，所述基部(9)在使用期间固定到患者的皮肤，所述套管装置包括一起限定至少一个腔体的壳体(1a、1b)和至少一个壁(4)，所述套管装置还包括安装在所述壳体(1a、1b)中、并且与所述至少一个腔体流体连通的套管(3)，所述套管装置设有用于将所述套管装置附装至所述基部(9)的装置(5)，其特征在于，用于将所述套管装置附装至所述基部的装置(5)定位在所述套管装置的近侧上，所述套管装置的近侧这里定义为安装套管装置后所述套管装置中面向患者的一面。
2.根据权利要求1所述的套管装置，其特征在于，用于将所述套管装置附装至所述基部(9)的装置(5)包括与所述基部(9)上的相对应的装置(7a)协同操作的机械特征部。
3.根据权利要求2所述的套管装置，其特征在于，用于将所述套管装置附装至所述基部(9)的装置包括从所述套管装置的近表面伸出的部件(5)，所述部件(5)能够枢转并由此在至少一个位置中暂时地减小由所述部件(5)的边缘形成的直径。
4.根据权利要求1所述的套管装置，其特征在于，用于将所述套管装置附装至所述基部(9)的装置(5)包括位于所述套管装置的近表面上的粘接至所述基部(9)的相对应表面的粘接表面。
5.根据权利要求1-4中的任意一项所述的套管装置，其特征在于，所述套管装置布置在***装置(14)中，所述***装置(14)设有覆盖所述套管装置的全部长度的覆盖部件(15)。
6.根据权利要求1-4中的任意一项所述的套管装置，其特征在于，所述壳体(1a、1b)包括呈现平滑外表面、并具有内部腔体的本体(1b)，所述内部腔体在远端处由能被针头(6)刺穿的壁(4)覆盖，并且在所述内部腔体的近端处嵌入有所述套管(3)，所述用于将所述套管装置附装至所述基部的装置(5)设在所述本体(1b)的外部近表面，用于将所述套管装置不可释放地附装至所述基部(9)的接收部分(7)。
7.根据权利要求6所述的套管装置，其特征在于，所述平滑外表面具有圆形的、多角的或椭圆的周边。
8.根据权利要求6所述的套管装置，其特征在于，覆盖所述内部腔体的远端的壁(4)能由尖的或钝的针头(6)刺穿。
9.根据权利要求6所述的套管装置，其特征在于，在所述套管装置被推靠在所述接收部分(7)上时，自动形成所述接收部分(7)与所述套管装置之间的不可释放的附装。
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AU2007280850A1 (en) 2008-02-07
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