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CN1243576C - 用于排出介质的器械 - Google Patents

用于排出介质的器械 Download PDF

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CN1243576C
CN1243576C CNB028143299A CN02814329A CN1243576C CN 1243576 C CN1243576 C CN 1243576C CN B028143299 A CNB028143299 A CN B028143299A CN 02814329 A CN02814329 A CN 02814329A CN 1243576 C CN1243576 C CN 1243576C
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obturator
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outer end
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CN1529622A (zh
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贝尔恩德·汉森
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    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
    • A—HUMAN NECESSITIES
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    • 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
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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
    • 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
    • A61M5/178—Syringes
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    • A61M5/282—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle using emptying means to expel or eject media, e.g. pistons, deformation of the ampoule, or telescoping of the ampoule by compression of deformable ampoule or carpule wall
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    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3275—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel being connected to the needle hub or syringe by radially deflectable members, e.g. longitudinal slats, cords or bands
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    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06—Ampoules or carpules
    • A61J1/067—Flexible ampoules, the contents of which are expelled by squeezing
    • A—HUMAN NECESSITIES
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    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
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    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/2013—Piercing means having two piercing ends
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
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    • A61M5/3245—Constructional features thereof, e.g. to improve manipulation or functioning
    • A61M2005/3247—Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
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    • 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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3202—Devices for protection of the needle before use, e.g. caps

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Abstract

本发明涉及一种用于排出介质的器械，它包括一个盛放所涉及介质有密闭装置(3)的排出容器(1)，密闭装置有一个用于要排出的介质的针头(11)，针头的外端(15)从密闭装置(3)伸出，在此器械内设一安全装置(5、17)，它可以从一个覆盖针头(11)外端(15)的保护状态，过渡到一个规定用于从针头(11)排出介质的使用状态。

Description

用于排出介质的器械
技术领域
本发明涉及一种用于排出介质的器械。此器械的一个主要但不是唯一的使用目的是，将要求容量的介质，尤其液体介质，灌入一盛放容器内。要灌入的介质优选地涉及一种添加剂，它例如作为生物活性物质掺合物加入一种已处于盛放容器的液体中。盛放容器可涉及一种输注容器，介质作为添加的生物活性物质掺入输注容器的内容物。
背景技术
为此，作为排出器械通常使用注射器，将它的针头戳穿盛放容器，例如输注容器的一个可穿孔的盖或塞子，然后通过压出注射器将介质注入盛放容器内。在此过程中需要充填注射器的准备工作步骤，以便将要求量的介质从一个储罐改灌到注射器内，或从一个传统的含有经测定剂量的所涉及介质的管形瓶给注射器充注。这种改灌工作步骤一方面很费时间，因为针头和注射器必须打开包装、将针头安装到注射器上、打开或扎入管形瓶并拉起注射器。另一方面在采取此措施过程中存在介质污染的严重危险。
在此类排出器械中的另一个问题是由针尖引起的伤害危险，这种危险是使用者在操作时遭受的。有鉴于此，在一种在文件US4735618中公开的已知的排出器械中设一安全装置，它包括一个覆盖针头端部的保险体，保险体可以从一个有效的保护状态过渡到一个规定用于从针头排出介质的失效的使用状态。为此目的，保险体可沿针头在一个处于针头端部的前移的保护位置与后移的使用位置之间移动。
在此已知器械中存在的缺点是，没有采取任何防止无意中过渡到使用位置的预防措施，在使用位置针头端部自由地伸出。此已知的器械只能在完成使用后保证安全，这是通过在器械使用后保险体超过针尖向前移出后将针尖悬置于保险体承接槽内达到的。因此这种已知的器械从安全的观点来看是不能令人满意的。
发明内容
从此现有技术出发，本发明的目的是要创造一种器械，它能在运输、储存和使用时提供更高的防伤害安全性。
为此，本发明提出一种用于排出介质的器械，包括一个盛放所涉及介质的有一密闭装置的排出容器，密闭装置有一个用于要排出的介质的针头，针头的外端从密闭装置伸出；以及包括一个安全装置，它可从一个覆盖针头外端的有效的保护状态过渡到一个规定用于从针头排出介质的失效的使用状态并有一保险体，保险体可以从一个在针头外端处的前移的保护位置后移到一个使用位置以及可重新前移到保护位置，其特征为：安全装置有一个围绕针头的伸出的外端并可从排出容器去除的保护罩，保护罩通过一个预定的断开位置与排出容器连接；并且，保护罩有一个转柄作为将保护罩从排出容器上拧下来的把手。
按本发明通过设一个围绕针头端部并可从排出容器去除的保护罩，不仅避免了安全装置保险体无意中后移的危险，而且除此之外还达到更高的防污染安全性。由于保护罩通过一个预定断开位置与排出容器连接，保护罩上设有一个用以将保护罩从排出容器上拧下来的转柄，因此，本发明的装置操作特别简便和顺手。
若针头外端规定用于戳穿盛放要排出的介质的容器上一个可穿孔的盖，则保险体在盖被戳穿时通过贴靠在盖上可从其在针头端部处的前移的保护位置后移到使用位置，以及在针头从盖拔出后重新前移到保护位置。在这种实施例中操作特别简单。
作为保险体，安全装置可以有一个可在针头从密闭装置伸出的部分上移动地导引的环状体，它通过一个产生固定力的弹性的固定装置与密闭装置连接，借助于固定装置的固定力，力锁合地保持在前移后覆盖针头端部的保护位置，以及可克服固定力沿针头后移到使用位置。上述环状体在其自由的端侧构成一个环形展宽的支承面，在安全装置向前的位置它沿径向超过安全装置其余部分伸出，以及借助展宽的支承面造成环状体与容器可戳穿的部位在其抽取口处可靠的接触特性。此外，基于此支承面，在可穿孔的排出容器盖被戳穿时，针头不会歪斜或损坏敏感的针头。
固定装置可由借助铰链再分的分别铰接地安置在环状体和密闭装置上的支承件构成，它们在保护位置基本上平行于针头延伸，以及，当环状体沿针头后移到使用位置时，它们延伸为从针头叉出的位置。
优选地，支承件是整体式成形在密闭装置上的杆状塑料件，它们大体在二分之一长度处通过弯曲铰链分开。在此设计中，支承件材料的固有弹性可以使环状体在后移到使用位置后自动重新至少部分地朝针头的前端移动，也就是说，环状体自动重新返回保护位置，或在器械使用后只须进一步少量地向前推移。因为弯曲铰链可以侧向完全折叠，所以构成各自的弯曲铰链的杆状塑料件可以互相叠靠，使针头在排出容器内达到大的插入深度，以及排出容器具有适当厚度尺寸的可穿孔的盖也可以如此借助针头准确地戳穿。
按一种特别有利的实施例，密闭装置带有围绕支承件的保险圈，它可以从密闭装置取下并可沿支承件朝支承件弯曲铰链的方向移动，以便将支承件锁定在与保护位置对应的位置。在这里，可在弯曲铰链处设止动槽，保险圈可以扣入止动槽内，所以安全装置可释放地锁止在保护位置，在此位置环状体保护地围绕着针头的外端。
排出容器可以是一个按已知的Bottelpack方法制造的塑料容器，在其开口端借助保护罩封闭前，密闭装置作为插入件插入此开口端。
插入件的主体在中心区含有一个连续地设在其中的针头，针头的内端从密闭装置的此主体朝排出容器的内腔方向略微伸出。构成密闭装置的插入件在针头面朝它的内端与处于排出容器内的介质之间有一薄膜作为截止元件，当处于排出容器内的介质压力升高时，薄膜压靠在针尖上并被针尖戳穿。
通过压缩排出容器，可导致升高介质的压力并由此实现薄膜的戳穿。
附图说明
下面借助附图表示的实施例详细说明本发明。
其中：
图1按本发明的排出器械一种实施例的侧视图，排出器械处于使用前的工作状态，亦即有套上的保护罩；
图2图1所示器械的纵剖面；
图3与图2相应的纵剖面，但保护罩已除去；
图4处于工作状态的器械的纵剖面，此时已刺入输注容器的一个可穿孔的盖内；
图5类似于图4的视图，但此时器械的排出容器已压缩；
图6处于压缩的并已从盖拔出的状态的器械纵剖面；以及
图7处于压缩的相应于安全装置保护位置的工作状态的器械纵剖面。
具体实施方式
在图1中，排出容器总体用1表示。在本实施例中，排出容器是一个按已知的Bottelpack方法制造的安瓿状塑料容器，它的壁2制有波纹并设计为波纹膜涨伸盒状，所以此排出容器1可以从图1至4中表示的形状压缩到图5至7所示的形状。在排出容器1的颈部，在其中装入一个密闭装置3作为插入件，在其由塑料成形的主体上成形多个结构部分。其中有安全装置17，它本身(在排出器械使用前)用保护罩5保护，保护罩5成形在排出容器1的主体上预定断开的位置7处(见图1和3)，以及有一个侧向伸出的转柄9，它用作操作把手，以便于将保护罩5在预定断开位置7处从排出容器上拧下来。图3表示与图1和2相同的器械工作状态，但保护罩5已除去。
尤其由图2和3可以看出，密闭装置3的主体在中心区被针头11穿过，针头的内端12超过密闭装置3的主体向内略微伸出。在针头11的内端12与排出容器1内腔之间有一薄膜13，它是密闭装置3插入件的一部分。
针头从密闭装置3主体的外端起沿一个长度延伸，这一长度大体相当于注射器针头的长度。图2、3和7表示一种工作状态，此时针头11伸出的外端15总是被一个处于保护位置其总体用17表示的安全装置覆盖，亦即保护。
安全装置17整体式成形在密闭装置3的主体上并有一环状体19，后者可在针头11上移动以及在针头11的外端15处于保护位置(见图2、3和7)，以便覆盖此针头端部，亦即针尖。环状体19通过整体成形的杆状支承件21与密闭装置3的主体连接成一体，其中，与环状体19和密封装置3主体的连接点按弯曲铰链的方式是柔性的。此外，在大约支承件21的二分之一长度上有弯曲铰链23，它将支承件21再分开。若环状体19从保护位置沿针头11移到器械的使用位置(见图5和6)，则支承件21邻接弯曲铰链23的区段回转，使它们从针头11叉开并如图5中所表示的那样叠合。
上面刚提到的图5和图4表示器械处于一种状态，此时针头11已用它的外端15戳穿输注容器26的一个可穿孔的盖25。在这里环状体19已从与针头外端15对齐的保护位置沿针头11的纵向后移到使用位置。通过压缩排出容器1的波纹状壁2(见图5)，处于其中的介质的压力被升高，所以薄膜13压靠在面朝它的针头11内端12上并被针头戳穿。因此，压缩排出容器1导致将处于其中的介质压入输注容器26内，从而在输注容器的内容物中掺合一种附加或生物活性物质的一个相应于排出容器1内容物的剂量。
图6表示排出容器1已压出的器械重新从输注容器26的盖25中拔出后的工作状态。基于支承件21的固有弹性，原先当针头刺入盖25内时通过贴靠在盖上克服支承件21的弹性或固定力从保护位置后移的环状体19，自动地在弹性力作用下重新部分地朝针头11的外端15方向前移。
图7表示器械完成使用后的工作状态，此时，虽然不再安装保护罩5，但针头11伸出的外端15仍重新受到安全装置17的防护。为此目的，从密闭装置上取下一个座落在密闭装置3主体上并可取下的保险圈29并沿针头11前移，此时它沿支承件21滑动以及支承件从图6所示的位置向针头11靠近，直至环状体19前移至针头11的外端15。在弯曲铰链23处，支承件21有成形的止动槽30，如图7所示，保险圈29卡锁在止动槽30内。
在保险圈29卡锁在支承件21弯曲铰链23处的止动槽30内后，尽管保护罩5已去除，针头11仍重新被覆盖其外端15的环状体19覆盖，所以此现在已排空的器械可以没有危险地废物处理。当然，按本发明的排出器械不仅可有利地使用于将要求容量的液态介质掺合在输注容器内，而且同样可以应用于排出液态或气态和/或充满微粒的介质，只要它们能够或需要通过针头排出。

Claims (9)

1.用于排出介质的器械，包括一个盛放所涉及介质的有一密闭装置(3)的排出容器(1)，密闭装置有一个用于要排出的介质的针头(11)，针头的外端(15)从密闭装置(3)伸出；以及包括一个安全装置(5、17)，它可从一个覆盖针头(11)外端(15)的有效的保护状态过渡到一个规定用于从针头(11)排出介质的失效的使用状态并有一保险体，保险体可以从一个在针头(11)外端(15)处的前移的保护位置后移到一个使用位置以及可重新前移到保护位置，其特征为：安全装置(5、17)有一个围绕针头(11)的伸出的外端(15)并可从排出容器(1)去除的保护罩(5)，保护罩通过一个预定的断开位置(7)与排出容器连接；并且，保护罩(5)有一个转柄(9)作为将保护罩(5)从排出容器(1)上拧下来的把手。
2.按照权利要求1所述的器械，其特征为：针头(11)的外端(15)规定用于戳穿盛放要排出的介质的容器(26)上一个可穿孔的盖(25)；以及，保险体在盖(25)被戳穿时通过贴靠在盖上可从其前移的保护位置后移到使用位置。
3.按照权利要求1所述的器械，其特征为：安全装置(5、17)的保险体由一个可在针头(11)从密闭装置(3)伸出的部分上移动地导引的环状体(19)构成，它通过一个产生固定力的弹性的固定装置与密闭装置(3)连接，借助于固定装置的固定力力锁合地保持在覆盖针头(11)外端(15)的前移的保护位置，以及可克服固定力沿针头(11)后移到使用位置。
4.按照权利要求3所述的器械，其特征为：固定装置有通过铰链分开的分别铰接地安置在环状体(19)和密闭装置(3)上的支承件(21)，它们在保护位置基本上平行于针头(11)延伸，以及在使用位置延伸到从针头叉出的位置。
5.按照权利要求4所述的器械，其特征为：支承件(21)按连续的整体从密闭装置(3)延伸到环状体(19)，并且大体在二分之一长度处通过弯曲铰链(23)分开。
6.按照权利要求5所述的器械，其特征为：密闭装置(3)带有一个围绕支承件(21)的保险圈(29)，它可以从密闭装置(3)取下并可沿支承件(21)朝支承件的弯曲铰链(23)方向移动，以便将支承件锁定在与保护位置对应的位置。
7.按照权利要求1至6之一所述的器械，其特征为：密闭装置(3)有一薄膜(13)，所述薄膜在处于排出容器(1)中的介质与面朝该薄膜的针头(11)内端(12)之间构成一截止元件，当介质的压力升高时，截止元件可压靠在针头(11)的内端(12)上并可被针头戳穿。
8.按照权利要求7所述的器械，其特征为：排出容器(1)有一个可变形的壁(2)并可以压缩使介质压力升高，以促使薄膜(13)戳穿。
9.按照权利要求8所述的器械，其特征为：排出容器(1)的壁(2)按波纹管的方式设计。
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