CN104548331B - 用于医疗线的流构件和相关制造方法 - Google Patents

用于医疗线的流构件和相关制造方法 Download PDF

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CN104548331B
CN104548331B CN201410584695.2A CN201410584695A CN104548331B CN 104548331 B CN104548331 B CN 104548331B CN 201410584695 A CN201410584695 A CN 201410584695A CN 104548331 B CN104548331 B CN 104548331B
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G.古亚拉
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Abstract

本发明涉及用于医疗线的流构件和相关制造方法。一种用于医疗线的注射部位(1)包括由模制的塑料材料制成的管状体(2)，在该注射部位(1)内，由热塑性材料制成的弹性元件(5)包覆模制在管状体(2)的扩大端部(3)上。扩大端部(3)界定内部环形凸缘(4)并形成有至少一个径向通孔(6)，通过该通孔而包覆模制弹性元件(5)，以便轴向地靠置在内部环形凸缘(4)上并用附件(7)填充径向通孔(6)。

Description

用于医疗线的流构件和相关制造方法
技术领域
本发明大体上涉及用于医疗线的流构件，该医疗线包括由模制塑料材料制成的管状体，在该管状体内装配弹性材料的密封元件。
特别地，本发明关注注射部位，在其中弹性材料的元件密封地闭合管状体的一端，并且在使用期间可通过引入针或插管而刺穿以用于管理医疗液体，且然后可在针或插管抽出之后弹性地重新闭合。
背景技术
在以上指出类型的已知流构件中，弹性元件由相对较软的插入物组成，分开地形成且然后装配入管状体，并且通过焊接、胶粘、管状体和类似系统的一部分的塑性变形而固定至该管状体。
在以相同申请人名义在文件EP-1717161B1中描述和示出的注射部位的情况下，还建议用热塑性材料制造弹性元件，并且在管状体的端部内且还部分地在其外部包覆模制(overmolding)其，以便也制造机械锚定件。该解决方案尽管是高效的，但是伴随某些问题：由其在管状体外模制的部分提供的弹性元件的机械保持涉及带有相对成本的注射热塑性材料的附加量、以及相对复杂和昂贵的模制设备的使用。
根据文件US-2009/188575、DE-102005015343、US-4842540以及US-4552384已知用于医疗线的流构件，其中，也是通过包覆模制制造的热塑性材料的弹性元件靠着管状体的内表面通过形成于管状体本身的壁中的至少一个径向通孔注射至该流构件中，并且在其中保留弹性元件的附件。在所有这些已知的解决方案中，弹性元件是带有薄壁的环形形状，并且以此方式制造的流构件因此由管状连接器而非注射部位组成。
文件EP-1857252A2描述了与权利要求1的前序部分对应的注射部位，其中也由热塑性材料制成且通过包覆模制或共同注射制造的弹性材料的元件密封管状体的一端并钩挂至形成于管状体内的环形轴向锚定部分。该机械锚定件被认为是必要的，以在使用期间防止弹性元件由于在引入和抽出针或插管期间施加至其的轴向力而导致的位移。关于薄弹性环状元件且形成有容纳于管状体的径向孔中的附件的前述解决方案的使用在本文件中完全不考虑，这可论证地是因为确信，也许甚至是由于技术偏见，根据这种确信或技术偏见，当这样的附件经受针或插管的轴向插入或拉出的动作时，其将不能够稳定地阻挡弹性材料的元件。内部锚定部分的存在伴随管状体的明显构建复杂性、以及与弹性元件的随后包覆模制相关联的困难。
发明内容
本发明旨在解决前述缺点，从而制得可用于上面限定类型的医疗线、可以以简单且经济的方式制造的注射部位，而不需要在管状体内形成复杂的机械锚定件以用于保持弹性元件。
根据本发明，该目标由于以下事实而实现：管状体的端部扩大以便界定内部环形凸缘，并且在该内部环形凸缘附近形成有至少一个径向注射通孔，通过该通孔而包覆模制弹性元件；以及由于以下事实：弹性元件轴向地靠置在管状体的所述内部环形凸缘上，并且具有至少一个填充所述至少一个径向通孔的附件。
由于该解决方案思想，在相对简单且经济的设备的帮助下获得弹性元件到管状体的安全锚定，既通过物理和化学的粘附，也通过由内部环形凸缘和管状体的径向通孔提供的保持。这样，弹性元件既在使用期间引入和抽出针或插管穿过其时关于轴向平移被高效地锁定，也在旋转上被锁定。
本发明还致力于一种用于制造注射部位的方法，其特征在于，该方法包括以下步骤：
制造带有一个扩大端部的管状体，该扩大端部界定内部环形凸缘，并且在其侧壁上具有至少一个与所述内部环形凸缘相邻的径向注射通孔，
以一种方式通过所述至少一个径向通孔将热塑性材料注射到管状体的所述扩大端部内，使得因此包覆模制的弹性元件由所述内部环形凸缘以及填充管状体的所述或相应径向通孔的至少一个附件阻挡。
附图说明
现在将参考纯粹以非限制性示例方式提供的附图而详细地描述本发明，其中：
图1是根据本发明制造的注射部位的示意正视图，以及
图2是根据图1的线II-II的轴向横截面视图。
具体实施方式
参考附图，数字1以其整体指示用于医疗线的注射部位或针尖，其包括具有一个扩大端部3的模制塑料材料的管状体2，该扩大端部3界定内部环形凸缘4。
管状体2的扩大端部3由相对柔软的热塑性材料的弹性元件5填充，该弹性元件密封穿过管状体2的通路，并且意图由针或插管穿孔以用于管理体疗产品通往在使用期间与管状体2的另一端连接的线。
弹性元件5通过包覆模制而制造，从而通过在内部环形凸缘4附近形成于扩大端部3的侧壁中的一个或更多径向注射通孔6将热塑性材料注射到管状体2的扩大端部3内。在包覆模制之后，弹性元件5如此形成为粘附靠着扩大端部3的侧壁并靠着内部环形凸缘4，并且呈现保留在径向通孔6内的填充其的附件7。这样，弹性元件5稳固地相对于管状体2轴向地锁定，不仅仅是由于物理-化学粘附，还通过内部环形凸缘4且通过也在旋转上产生保持的径向附件7。该附件7完全适合于在使用期间抽出先前已插入穿过弹性元件5的针或插管时防止弹性元件5在与内部环形凸缘4相反的方向上的轴向位移。
弹性元件5可以以示例中所示方式形成有在与环形凸缘4相反的一侧上提供的凹部8。
当然，构造和实施例的细节可以关于已描述和已示出的那些而广泛地变化，而不由此脱离如在所附权利要求中限定的本发明的范围。因此，为了弹性元件5的包覆模制热塑性材料的注射，可提供附加的角向分布的径向孔6，甚至轴向地偏移，以便产生甚至更强的弹性元件5的机械保持。

Claims (2)

1.一种用于医疗线的注射部位(1)，所述医疗线包括由模制的塑料材料制成的管状体(2)，在所述注射部位(1)内装配密封地闭合所述管状体(2)的一端部(3)的弹性元件(5)，其中所述弹性元件(5)由热塑性材料制成并且被包覆模制在所述管状体(2)内，其特征在于：
- 所述管状体(2)的所述端部(3)扩大以便界定内部环形凸缘(4)，并且在所述内部环形凸缘(4)附近形成有至少一个径向注射通孔(6)，通过该通孔而包覆模制所述弹性元件(5)，
- 所述弹性元件(5)轴向地靠置在所述管状体(2)的扩大端部(3)的所述内部环形凸缘(4)上，并且呈现填充所述至少一个径向注射通孔(6)的至少一个附件(7)，
- 所述弹性元件能够由针或插管刺穿以用于管理医疗液体，且然后在所述针或插管从所述弹性元件抽出之后能够弹性地重新闭合。
2.一种用于制造用于医疗线的注射部位(1)的方法，所述医疗线包括模制的塑料材料的管状体(2)，在所述注射部位(1)内装配密封地闭合所述管状体(2)的弹性元件(5)，其中所述弹性元件(5)由热塑性材料制成并且被包覆模制在所述管状体(2)内，所述弹性元件能够由针或插管刺穿以用于管理医疗液体，且然后在所述针或插管从所述弹性元件抽出之后能够弹性地重新闭合，其特征在于，该方法包括以下步骤：
- 制造带有一个扩大端部(3)的管状体(2)，所述扩大端部(3)界定内部环形凸缘(4)并且在其侧壁上具有与所述内部环形凸缘(4)相邻的至少一个径向注射通孔(6)，
- 以一种方式通过所述至少一个径向注射通孔(6)将所述热塑性材料注射到所述管状体(2)的所述扩大端部(3)内，使得因此包覆模制的所述弹性元件(5)由所述内部环形凸缘(4)和填充所述管状体(2)的相应径向注射通孔(6)的至少一个附件(7)阻挡。
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