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CN101277730B - 用于预充式注射器的针头组件 - Google Patents

用于预充式注射器的针头组件 Download PDF

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CN101277730B
CN101277730B CN2006800320535A CN200680032053A CN101277730B CN 101277730 B CN101277730 B CN 101277730B CN 2006800320535 A CN2006800320535 A CN 2006800320535A CN 200680032053 A CN200680032053 A CN 200680032053A CN 101277730 B CN101277730 B CN 101277730B
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A·费边
S·拜耶勒
A·埃贝勒
J·科瓦克
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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
    • 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
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    • 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
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    • Y—GENERAL 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
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    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
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    • Y10T29/49—Method of mechanical manufacture
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    • Y10T29/49904—Assembling a subassembly, then assembling with a second subassembly

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Abstract

本发明公开了一种用于预充式注射器的针头组件(10；210)。针座(12；212)具有固定在其上的针头(14；214)并且适合被固定到注射器的注射筒上。针头护套(16；216)具有可与针座(12；212)形成可拆卸式无菌密封的远端，并且包围和屏蔽针头(14；214)。针头密封件(18；218)设置在针尖上并且至少部分地布置在针头护套(16；216)的近端中并且通过封闭件(20；220)封闭。封闭件(20；220)和针头护套(16；216)之间的封闭连接为通过粘接或焊接形成的不可拆卸式的无菌屏障(54；254)。

Description

用于预充式注射器的针头组件
技术领域
本发明涉及一种用于预充式注射器的针头组件，特别但又不限于内部借助在加热管道中以高达350℃的温度烘烤渗硅和灭菌而形成涂层的预充式注射器类型，该针头组件包括：针座、针头护套和针头密封件，针头固定在所述针座上，针座可被固定在注射器的注射筒上，所述针头护套的远端可靠地无菌密封针座，而且可拆卸地连接到针座上并且屏蔽地包围针头，针头密封件用来安装针尖并且至少部分地布置在针头护套的被封闭件封闭的近端中。
背景技术
这种类型的系统已公知并且尤其在专利文献中公开。尽管如此，很多这种已知的系统在生产和/或应用中存在缺点或过于复杂。
因此，在WO94/22511中描述了一种系统，其中，具有粘接针头、针头密封件以及针头护套的预组装针头组件可以例如在无菌环境中组装到渗硅且灭菌的注射筒上。端盖和套管护套之间的速动连接装置(snap-action connector)连同端部接触面并不构成用于针头的微生物屏蔽。通过盖和套管护套的速动连接、挤压所述盖和套管护套中的套管护套来密封所获得的包围针头表面的空腔，致使针头表面无菌。这种速动连接装置可以设计成可拆卸式，因而就致使针头表面无菌而言具有一定的风险，因为可能例如在运送或处理过程中出现未被注意到的松动。
EP 0 240 787描述了一种用于注射用针头的屏障系统，该系统包括粘接针头、针头密封件和针头护套。其中没有提及如何确保致使针头无菌。提到通过轴向交错的筋条实现外壳和针头接口的连接，其尽管能实现外壳的特定固定位置，但是无法确保必要的微生物密封或无菌密封。
发明内容
因此，本发明的目的在于改进普通针座，以在针座的成本节约的生产中确保针座的无菌密封，进而现在能可靠地确保整个针头在针头组件的消毒和将针头组件投入使用期间保持无菌。
为了实现这一目的，本发明以封闭件和针头护套之间的封闭连接为特征，该封闭连接为通过粘接或焊接工艺形成的不可拆卸式无菌屏障。
本发明的其它实施方式的优点见从属权利要求。
因而，无菌屏障优选为通过超声波或激光焊接形成的封闭连接。
如果使用粘接连接，那么推荐使用适合通过紫外光或在室温下固化的无毒的丙烯酸树脂基粘接剂，例如81925 Munich的HenkelLoctite Deutschland GmbH的型号为LOCTITE3011的粘接剂、Desmoines，USA的Barton Solvents Inc.制造的环氧树脂。
实验表明优选使用无定形的热塑性塑料(例如聚碳酸酯或聚苯乙烯)或者部分结晶的热塑性塑料(例如聚丙烯或聚乙烯)制造封闭件和针头护套能产生良好的效果。
在一种特别优选的实施方式中，封闭件为带有圆柱形套筒的盖，而且针头护套为管状构件，针头护套的近端设有环形凸缘，盖壳体的远侧边缘连接到针头护套的环形凸缘上形成无菌屏障。
在这种实施方式中，针头护套的环形凸缘在其近端侧的外部边缘上可以有利地设置用于固定盖壳体的底部边缘的环形面。
更有利的是，盖壳体的远侧边缘包括互锁轮廓，而且针头护套的环形凸缘的环形固定面包括形状与盖壳体的互锁轮廓相适应的容纳轮廓，并且在容纳轮廓中插入互锁轮廓以形成刚性互锁和/或非刚性互锁。在盖壳体的远侧边缘上的互锁轮廓也可以为能量导向器，在此处可与针头护套实现超声波焊接。
本发明的另一方面以支承轴颈为特征，该支承轴颈在用于封闭件的外环形固定面中从针头护套的环形凸缘的近端侧径向地向前突出。
为了补充该构造，优选的是，针头密封件在其近端设有由针头护套的支承轴颈支承的凸缘型延伸部。盖的远端侧与针头密封件的近端接触。在本发明的另一种实施方式中，针头密封件的凸缘型延伸部的近端侧设有与封闭件的顶侧的远端侧接触的环形轴颈。
在这种布置中，优选的是，针头护套的支承凸缘和支承轴颈在针头护套的支承凸缘上可以分别包括圆柱形中心孔，所述中心孔的孔与针头护套的圆柱形内表面区域的孔对应。
在第二实施方式中这一方面可以修改，使得针头护套的支承轴颈的内表面区域向近侧锥形地张开，并且针头密封件的凸缘型延伸部具有圆周面区域，该圆周面区域至少在其远端的一部分上与支承轴颈的锥形内表面区域的形状匹配，并且被该锥形部分支承在支承轴颈的内表面区域上。
此外，推荐的是，针头密封件的容纳针尖的远端包含用于针头的中心开口。
而且，针头密封件的布置在凸缘型延伸部远侧的纵向部分通过支承轴颈延伸进入针头护套的近端。在这种布置中，该远侧纵向部分的直径可以小于或等于针头护套的内部空间的直径。
另外，特别优选的是，针头护套在其远端通过易碎连接部一体地连接到针座的近侧部分上，从而可以在仅仅破坏单个易碎连接部后完全暴露出准备就绪的针头。
推荐的是，由药用橡胶或热塑性弹性体生产针头密封件。
总之，针头优选由不锈钢制造，并且与注射器的针筒同轴地牢固粘接在针座中，或者通过塑料灌封牢固地连接到针座上。针座本身可以优选由热塑性塑料(如聚碳酸酯、聚丙烯或聚酰胺)制成。
从上述评论可以理解，根据本发明的针头组件由于在封闭件和针头护套之间的无菌屏障，在打开预充式注射器时具有防干扰功能，同时确保简化了针头组件生产中的生产和零件组装，以及简化了将针头组件组装到渗硅注射筒上的过程。
制造针头组件的优选方法包括：将针头固定在适合被固定在注射器的注射筒上的针座上；将针头护套的远端可拆卸地连接到针座上以形成无菌密封并且包围和屏蔽针座；将针头密封件布置在针尖上并至少部分地布置在针头护套的近端中；以及使用封闭件通过在封闭件和针头护套之间的封闭连接封闭针头密封件的近端，所述封闭连接为通过粘接或焊接形成的不可拆卸式无菌屏障。
在一种特别的制造方法中，形成第一分组件(针头密封件、封闭件和针头护套)，其中针头密封件至少部分地布置在针头护套的近端，并且封闭件封闭针头密封件的近端，通过将针头固定在针座上形成第二分组件，并且第一分组件和第二分组件相互作用，使得针头护套在其远端可拆卸地连接到针座上以形成无菌密封，并且包围和屏蔽针头，针头密封件位于针尖上。
在另一种制造方法中，通过将针头固定在针座上形成第一分组件，通过将第一分组件插入针头护套中形成第二分组件，通过将针头密封件安装在第二分组件的针尖和针头护套上形成第三分组件，并且通过在封闭件和第三分组件的针头护套之间形成封闭连接完成针头组件。
附图说明
现在参照附图借助实施方式详细描述本发明，其中：
图1是根据本发明的第一实施方式的针头组件的在生产后的沿纵向中心线的剖面图；
图2是根据本发明的第二实施方式的针头组件的在生产后的沿纵向中心线的剖面图；
图3是带有能量导向器的盖在组装前的沿纵向中心线的放大剖面图，该盖用于如图1或2所示的针头组件的针头护套；
图4是用于针头组件的盖的变型的第二实施方式的沿纵向中心线的放大剖面图；
图5是如图1所示的针头组件的针头密封件的沿纵向中心线的放大剖面图；和
图6是如图2所示的针头组件的针头密封件的沿纵向中心线的放大剖面图。
具体实施方式
现参照图1，示出了用于由玻璃或塑料制成的预充式注射器(众所周知故而未示出)的针头组件，预充式注射器内部通过在加热通道中以高达350℃的温度烘烤渗硅并灭菌而形成涂层。针头组件10包括针座12和固定在针座12上的针头14、针头护套16、针头密封件18以及封闭件20。
详细地说，针座12为锥形，特征在于其远端的锥形开口22设有环形槽24，针座12可以借助预充式注射器(众所周知故而未示出)的环形边缘装配到模制筒上，并且通过速动连接固定到其上。锥形开口22在其近端转变成圆柱形孔26，针头14通过其远端借助粘接剂28共轴地固定在圆柱形孔26中。有用的粘接剂为适合通过紫外光或在室温下固化的无毒的丙烯酸树脂基粘接剂，例如81925Munich，Henkel Loctite Deutschland GmbH的型号为LOCTITE
Figure 2006800320535_1
3011的粘接剂，USA，Desmoines的Barton Solvents Inc.制造的环氧树脂。
如有需要，针头14也可由将针头模制在针座中的套筒固定，从而与用于生产针座相同的塑料材料可被用于用来在注塑工艺中模制针座的套筒。
针头14的长度可以不同，优选由型号为AISI 314的不锈钢制造，而且为套管，针头的同轴孔在其远端暴露。针座12的近端为包围粘接针头14的环形面30。优选的是针座12由热塑性塑料制成，如聚碳酸酯、聚丙烯或聚酰胺。
针头护套16主要包括管状纵向部分32，其远端是可靠的无菌密封件，该密封件通过圆周式易碎连接部52连接到针头护套16的环形面30的外边缘，可以通过施加致断力来手动地解除易碎连接部52。
针头护套16与针座12同轴地延伸，在整个长度上以一致的径向间隙包围针头14。针头护套16的外径仅仅稍大于针座12的环形面30的直径。
针头护套16的环形纵向部分32延伸超过针头的针尖(在图1中未示出)，环形纵向部分32的近端以包围开口的环形凸缘34为特征，该开口的直径大致对应于针头护套16的内径。
环形凸缘34向外延伸出针头护套16的圆柱形外侧。环形凸缘34的近端以其外侧边缘上的环形固定面36为特征，环形支承轴颈38设置在该环形固定面36之内。该支承轴颈38的内径分别大致对应于针头护套16和环形凸缘34的内径。优选的是，针头护套16由部分结晶的热塑性塑料制成，例如聚丙烯或聚乙烯。
在如图1和图2所示的针头组件的两种实施方式中，针头密封件18由弹性材料制成，例如药用橡胶或热塑性弹性体，用于防护地容纳针头14的包括斜面针尖的近端，针头密封件18至少部分地设置在针头护套16的近端中。
现参见如图1所示的第一实施方式，其明确了针头密封件18包括以锥形远端40为特征的模制件，所述锥形远端40包含在针头密封件18的大致一半长度上延伸的用于针尖的中心孔42。锥形远端40过渡成与针头护套16的支承轴颈38的圆柱形内表面区域46接触的短圆柱形纵向部分44。针头密封件18在该短圆柱形纵向部分44之前设有用于将针头密封件18支承在针头护套16的支承轴颈38上的凸缘型延伸部48。针头密封件18的近端由从针头密封件18的凸缘型延伸部48的近端的外侧边缘突出的环形轴颈50形成。
现参见图5，示出了针头密封件18的一种变型的实施方式，其中仅仅锥形纵向部分40和位于该锥形纵向部分40之前的圆柱形纵向部分44的长度大致相同。环形轴颈50具有三角形横截面，该三角形横截面的顶点在近侧。
针头组件10的近端包括封闭针头护套16的封闭件20，封闭件20和针头护套16之间的这一封闭连接构成无菌屏障54。
现再次参见图1，示出了封闭件20为带有顶板58的盖56，圆柱形壳体60从顶板56的外边缘向远侧延伸。圆柱形壳体60的远侧边缘62连接到针头护套16的环形凸缘34的固定面36上，形成无菌屏障54。在这种布置中，密封件20夹紧针头密封件18的位于支承轴颈38之前的部分以及支承轴颈38。
封闭件20和针头护套16之间的无菌屏障54尤其有利地包括粘接或焊接。
如果使用粘接，如上所述推荐使用适合通过紫外光或以室温固化的无毒的丙烯酸树脂基粘接剂，例如81925 Munich的HenkelLoctite Deutschland GmbH的型号为LOCTITE
Figure 2006800320535_2
3011的粘接剂，USA，Desmoines的Barton Solvents Inc.制造的环氧树脂。
在使用焊接工艺时，优选的是超声波或激光焊接工艺。
如果使用超声波焊接，如图3所示的封闭件20在其盖壳体60的远侧边缘62上优选配有能量导向器64，该能量导向器64远端逐渐变细形成三角形横截面，用于更快且更有效地将盖壳体60的远侧边缘62焊接到针头护套16的环形凸缘34的外边缘处的固定面36上。
参见图4，示出了作为封闭件20的盖66，盖66的圆柱形壳体包括远侧自由端，该远侧自由端具有垂直于封闭件20的纵向中心线延伸的平滑环形面区域68。这种实施方式通过形成无菌屏障54的粘接来封闭针头护套16。
推荐用无定形热塑性塑料(例如聚碳酸酯或聚苯乙烯)或者部分结晶的热塑性塑料(例如聚丙烯或聚乙烯)来制造封闭件20。
再次参见图1，示出了盖型封闭件20的顶板58通过其远侧侧面70(图3)与针头密封件18的近端接触。在第一实施方式的这一布置中，封闭件20仅仅与针头密封件18的弹性环形轴颈50接触，部分地挤压弹性环形轴颈50，从而当针头护套16通过封闭件20无菌地封闭时，针头密封件18的凸缘型延伸部48按压在针头护套16的支承轴颈38上。
现参见图2，示出了根据本发明的第二实施方式的针头组件210，其中第二实施方式的相似或相同的元件通过第一实施方式中的相同附图标记标示，但是增加前缀2。
针头组件210与第一实施方式的针头组件20的本质区别在于，针头护套216的支承轴颈238的内表面区域向近侧锥形地张开。如图2和图6清晰所示，针头密封件218的近侧凸缘型延伸部248包括圆周面区域，该区域在其远端的至少局部部分与支承轴颈238的锥形内表面区域246的形状匹配，从而通过该锥形局部部分246支承在支承轴颈238的锥形内表面区域246上。
针头密封件218的在凸缘型延伸部248远侧延伸的部分240为圆柱形，与支承轴颈238以及针头护套216的近端互锁，从而形成自由环形间隙251。在这种情况下，针头密封件218也由药用橡胶或热塑性弹性体制成。
该第二实施方式在针头密封件218上还缺少从凸缘型延伸部朝着封闭件220的顶板258的远侧向远端突出的环形轴颈，导致针头密封件218的凸缘型延伸部的近侧与封闭件220的顶板258的远侧270直接接触。尽管如此，在第二实施方式中，当针头密封件218固定地且不可拆卸地连接到针头护套216从而通过针头护套216形成无菌屏障254时，针头密封件218的弹性材料也受到封闭件220的挤压。
组装盖型封闭件和针头护套的两种主要工艺如下：
1.通过焊接或粘接工艺接合封闭件，通过保证完整长度的接缝(无菌屏障54；254)确保良好的密封。
2.在接合或组装封闭件和针头护套时定位针头密封件的凸缘，从而将针头间隙与环境的微生物隔离或与环境无菌地隔离。
出于完整性的考虑，组装上述针头组件的步骤列出如下，省略质量检测步骤：
1.拾取和放置针座；
2.拾取和放置针头，并且将针头定位在针座中；
3.分配粘接剂及其所需的后续步骤，例如固化；
4.拾取和放置封闭件；
5.拾取和放置针头密封件；
6.将针头密封件插入封闭件中；
7.拾取和放置针头护套；
8.将针头护套插在包括针头密封件的封闭件上；
9.连接和安置方法：通过焊接或粘接及可能需要的后续步骤(例如固化粘接剂)将封闭件固定在针头护套上，以形成无菌屏障；
10.将针头和针座插入带有封闭件和针头密封件的针头护套中。
另一种组装方法如下：
1.拾取和放置针座；
2.拾取和放置针头，并且将针头定位在针座中；
3.分配粘接剂及其所需的后续步骤，例如固化；
4.拾取和放置针头护套；
5.将针头和针座插入针头护套中；
6.拾取和放置针头密封件并将其安装在针尖和/或针头护套上；
7.拾取和放置封闭件并将其安置到针头护套上；
8.连接和安置方法：通过焊接或粘接及可能需要的后续步骤(例如固化粘接剂)将封闭件固定在针头护套上，以形成无菌屏障。
因此应当理解，根据本发明的针头组件确保针头在预充注射器的存储过程中保持无菌，因而导致其能可靠地防干扰。另外，在大批量生产中，能简便地将针头组件装配到渗硅和消毒的注射筒上。所有的各种零部件都能简便地制造和装配。

Claims (23)

1.一种用于预充式注射器的针头组件(10；210)，包括：
能够被固定到注射器的注射筒上的针座(12；212)和固定在针座(12；212)上的针头(14；214)；
针头护套(16；216)，其远端可拆卸地连接到针座(12；212)上以形成无菌密封，并且所述针头护套(16；216)包围和屏蔽所述针头(14；214)，所述针头护套(16；216)为管状构件(32；232)；
针头密封件(18；218)，其设置在针尖上并且至少部分地布置在针头护套(16；216)的近端中；和
封闭件(20；220)，其封闭所述针头密封件的近端，所述封闭件(20；220)为带有圆柱形壳体(60；260)的盖(56；256)，所述圆柱形壳体(60；260)具有远侧边缘(62；262)；
所述封闭件(20；220)和针头护套(16；216)之间的封闭连接为通过粘接或焊接形成的不可拆卸式无菌屏障(54；254)，
其特征在于：所述针头护套(16；216)的近端设有环形凸缘(34；234)，所述盖的壳体(60；260)的远侧边缘(62；262)连接到所述针头护套(16；216)的所述环形凸缘(34；234)上，形成无菌屏障(54；254)。
2.如权利要求1所述的针头组件，其特征在于：所述无菌屏障(54；254)通过超声波焊接形成。
3.如权利要求1所述的针头组件，其特征在于：所述无菌屏障(54；254)通过激光焊接形成。
4.如权利要求1所述的针头组件，其特征在于：使用适合通过紫外光或在室温下固化的无毒丙烯酸树脂基粘接剂通过粘接工艺形成所述无菌屏障(54；254)。
5.如权利要求1所述的针头组件，其特征在于：在所述针头护套(16；216)的所述环形凸缘(34；234)的近侧的外边缘上设有用于固定所述盖的壳体(60；260)的所述远侧边缘(62；262)的环形面(36；236)。
6.如权利要求5所述的针头组件，其特征在于：
支承轴颈(38；238)从所述针头护套(16；216)的所述环形凸缘(34；234)的近侧在用于所述封闭件(20；220)的所述环形面(36；236)内沿径向向前突出，
所述针头密封件(18；218)的上端具有凸缘型延伸部(48；248)，所述针头密封件(18；218)借助该凸缘型延伸部(48；248)由针头组件的所述针头护套(16；216)的所述支承轴颈(38；238)支承，以及
所述封闭件(20；220)的远侧(70)与所述针头密封件(18；218)的近端接触。
7.如权利要求6所述的针头组件，其特征在于：所述针头密封件(18；218)的所述凸缘型延伸部(48；248)的近端设有与所述封闭件(20；220)的顶板(58；258)的远侧(70；270)接触的环形轴颈(50；250)。
8.如权利要求6所述的针头组件，其特征在于：所述针头护套(16)的所述环形凸缘(34)和所述支承轴颈(38)在所述针头护套(16；216)的所述环形凸缘(34)处都包括一圆柱形内表面区域(46)，该圆柱形内表面区域(46)的孔对应于所述针头护套(16)的圆柱形内表面区域的孔。
9.如权利要求6所述的针头组件，其特征在于：所述针头护套(216)的所述支承轴颈(238)的内表面区域(246)向近侧锥形地张开，所述针头密封件(218)的所述凸缘型延伸部(248)具有圆周面区域，该圆周面区域在其远端的至少局部部分(249)上匹配所述支承轴颈(238)的呈锥形的所述内表面区域(246)的形状，并且通过呈锥形的所述局部部分(249)支承在所述支承轴颈(238)的所述内表面区域(246)上。
10.如权利要求1所述的针头组件，其特征在于：所述针头密封件(18)的容纳所述针尖的远端包含用于所述针头(14)的中心孔(42)。
11.如权利要求6所述的针头组件，其特征在于：所述针头密封件(18；218)的布置在所述凸缘型延伸部(48；248)的远侧的部分(40；240)延伸到所述支承轴颈(38；238)中，到达所述针头护套(16；216)的近端，并且具有与所述针头护套(16；216)的内部空间的直径相同的直径。
12.如权利要求1所述的针头组件，其特征在于：所述针头护套(16；216)在其远端通过易碎连接部(52；252)一体地连接到所述针座的近侧部分上。
13.如权利要求1所述的针头组件，其特征在于：所述封闭件(20；220)和所述针头护套(16；216)由无定形的或部分结晶的热塑性塑料制成。
14.如权利要求13所述的针头组件，其特征在于：所述热塑性塑料包括聚丙烯或聚乙烯。
15.如权利要求1所述的针头组件，其特征在于：所述针头密封件(18；218)由药用橡胶或热塑性弹性体制成。
16.如权利要求1所述的针头组件，其特征在于：所述针头(14；214)由不锈钢制成。
17.如权利要求1所述的针头组件，其特征在于：所述针头(14；214)固定地粘接在所述针座(12；212)中，与所述针头护套(16；216)同轴。
18.如权利要求1所述的针头组件，其特征在于：所述针头(14；214)通过塑料灌封固定地连接到所述针座(12；212)上。
19.如权利要求1所述的针头组件，其特征在于：所述针座(12；212)由热塑性塑料制成。
20.如权利要求19所述的针头组件，其特征在于：所述热塑性塑料包括聚碳酸酯、聚丙烯或聚酰胺。
21.一种制造用于预充式注射器的针头组件(10；210)的方法，包括：
将针头固定在能够被固定到注射器的注射筒上的针座(12；212)上；
将针头护套(16；216)的远端可拆卸地连接到所述针座(12；212)上，以形成无菌密封并且包围和屏蔽针头(14；214)，所述针头护套(16；216)为管状构件(32；232)；
将针头密封件(18；218)设置在针尖上，并且至少部分地设置在针头护套(16；216)的近端中；和
使用封闭件(20；220)封闭针头密封件的近端，所述封闭件(20；220)为带有圆柱形壳体(60；260)的盖(56；256)，所述圆柱形壳体(60；260)具有远侧边缘(62；262)；
其特征在于：
通过粘接或焊接在所述盖的壳体(60；260)的远侧边缘(62；262)和设置在所述针头护套(16；216)的近端的环形凸缘(34；234)之间形成封闭连接，所述封闭连接为不可拆卸式无菌屏障(54；254)。
22.如权利要求21所述的方法，其中：
形成由针头密封件(18；218)、封闭件(20；220)和针头护套(16；216)组成的第一分组件，其中针头密封件(18；218)至少部分地布置在针头护套(16；216)的近端中，并且封闭件(20；220)封闭针头密封件的近端；
通过将针头(14；214)固定在针座(12；212)上形成第二分组件；和
第一分组件和第二分组件相互作用，使得针头护套(16；216)在其远端可拆卸地连接到针座(12；212)上以形成无菌密封，并且针头护套(16；216)包围和屏蔽针头(14；214)，针头密封件(18；218)位于针尖上。
23.如权利要求21所述的方法，其中：
通过将针头(14；214)固定在针座(12；212)上形成第一分组件；
通过将第一分组件插入针头护套(16；216)中形成第二分组件；
通过将针头密封件(18；218)安装在第二分组件的针尖和针头护套(16；216)上形成第三分组件；和
通过在封闭件(20；220)和第三分组件的针头护套(16；216)之间形成封闭连接完成针头组件。
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