CN101557845B - 输液套装 - Google Patents

输液套装 Download PDF

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CN101557845B
CN101557845B CN2007800403212A CN200780040321A CN101557845B CN 101557845 B CN101557845 B CN 101557845B CN 2007800403212 A CN2007800403212 A CN 2007800403212A CN 200780040321 A CN200780040321 A CN 200780040321A CN 101557845 B CN101557845 B CN 101557845B
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infusion
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CN101557845A (zh
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H·蒂普斯马克
J·E·尼尔森
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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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M39/1011—Locking means for securing connection; Additional tamper safeties
    • 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
    • A61M25/02—Holding devices, e.g. 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • 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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • 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
    • A61M2005/1587—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body suitable for being connected to an infusion line after insertion into a patient
    • 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
    • A61M25/02—Holding devices, e.g. on the body
    • A61M2025/028—Holding devices, e.g. on the body having a mainly rigid support structure

Abstract

本申请涉及输液套装，包括：输液部件(1)，其包括具有主平面的基部(3)、从所述基部的主平面延伸的头部(6)和从所述基部延伸出来的插管(12)；第一固定器件；连接件(2)，其具有与所述基部(3)的主平面平行并且位于该主平面上方的平面，并且具有一个或多个臂(15)，所述臂的第一端部被固定到连接件并且第二相对端部为自由的，以及导管(14)；引导器件(7，16)；第二固定器件(8、17)，所述第二固定器件为定位在连接件的臂上的突出的连接件保持装置(17)的形式，其适于与从基部延伸出来的保持装置(8)相接合，其中所述连接件的平面可以被倾斜成与基部相距一段距离，使第二端部被移位大于所述保持装置的高度(h)的距离。

Description

输液套装
技术领域
本发明涉及一种用于间歇地或连续地施用诸如胰岛素这样的治疗物质的输液套装。此外，本发明还设计包括注射器装置和输液套装的成套工具。
输液套装包括带有用以刺入患者皮肤的插管的输液部件和用于将输液部件与医疗装置连接起来的连接件，所述医疗装置优选是诸如胰岛素泵这样的医疗装置。输液套装在其组装形式下形成基本上平整的后侧面和相对其厚度较大的宽度，由此容许其平贴在患者的皮肤上，并且由此减轻了承载该输液套装所产生的不舒适感。
所述输液部件在持续较长的非特定时间周期内被置于患者的身体上，并且同时所述连接件有可能被时不时地连接和断开连接。由此，对于患者来说能够与医疗装置例如连接到药物储器的泵断开连接、到处走动以及在之后的某一时刻与所述医疗装置重新连接。还有，能够利用相同的输液部件在不同的医疗装置(比如不同的药物存储器)之间转换，并且由此只需要一次刺入皮肤操作，对患者来说减轻了不舒适感。
一些人对使用医用针头刺入他们自己的皮肤存在反抗或犹豫心理，并且因此在为适当地施用药物而正确地放置针头或插管时遇到了困难。因此可以使用一种将输液套装放置在患者的皮肤中的注射器装置。
背景技术
WO2005/092410A1说明了一种间歇或连续地施用诸如胰岛素这样的治疗物质的输液套装，其包括用于插入患者体内的输液部件和用于通过导管将输液部件与医疗装置连接起来的连接件，所述连接件能够相对于所述输液部件轴向地移动。所述输液部件包括粘性支撑件、带有第一组导向器件的基部和用于将所述连接件锁定在输液部件上的至少两个保持装置，一插管从所述基部延伸出来并且与腔体流体连通。所述腔体还适合于接收从所述连接件延伸出来的第二插管，该第二插管与导管流体连通。所述连接件还包括至少两根臂，所述臂包括与从所述基部延伸出来的保持装置相对应的器件。
当所述臂处于锁定位置时，该输液套装的输液部件和连接件之间的联接机构非常结实。对于这种已知的输液套装，当所述输液部件被放置在患者的皮肤上时，拉动连接件远离输液部件的风险/机会是可以忽略的，这是因为该装置具有面朝前的臂和相应的保持装置。
当患者偶然地通过沿向上的方向拉动经由连接件从输液套装中延伸出来的导管而拉动所述导管或使所述导管超负荷时，将导致连接件相对于输液部件倾斜，从而使输液部件上的保持装置和连接件的两根臂上的相应保持装置之间的接合紧密。这样，当所述连接件或连接件的导管受到沿向上的方向的超负荷或拉动时，连接件和输液部件之间的结实的联接机构将导致连接件和输液部件不能够彼此断开连接，而是导致整个输液套装被从患者的皮肤中拉出。因此患者需要被重新插入新的输液套装并从而产生不舒适感。
因此，本发明的目的是提供一种在输液部件和连接件之间具有联接机构的输液套装，当输液套装承受超负荷或意外地拉动从连接件中延伸出来的导管时，所述联接机构将连接件与输液部件分离。
本发明的另一个目的是提供一种能够清楚地看到插入位置的输液套装。
发明内容
本发明的第一方面涉及一种穿过患者的皮肤间歇地施用治疗物质的输液套装，包括：输液部件，其包括具有主平面的基部、从所述基部的主平面延伸的头部和从所述基部延伸进入患者皮肤的插管；将输液部件固定到患者皮肤的第一固定器件；连接件，其具有与所述基部的主平面平行并且位于所述主平面上方的平面，还具有一个或多个臂，所述臂的第一端部被固定到连接件上并且第二相对端部是自由的，一导管用于将输液套装与一医疗装置连接；将输液部件和连接件彼此相对定位的引导器件；将连接件固定到输液部件的第二固定器件，所述第二固定器件为定位在连接件的臂上的突出的连接件保持装置的形式，所述连接件保持装置适于与从基部延伸的相应保持装置相接合，其中，连接件的平面可以被倾斜成与基部相距一段距离，使第二端部被移位大于所述保持装置的高度的距离，当连接件通过引导器件相对于输液部件定位时，所述保持装置定位在基部的第二端部中。
此外，当连接件定位在引导器件中时，所述连接件能够在第一端部绕一轴线枢转，所述轴线与基部的主平面平行并且与输液部件的纵向轴线A垂直。
令人惊奇地，上述输液套装在患者使用方面看起来比先前已知的输液套装更加安全，这是因为，当例如通过意外拉动导管使连接件沿倾斜的运动从输液部件中推开或拉出时，当将连接件与输液部件断开连接的力小于将输液部件从患者皮肤上移除的力时，所述输液部件将断开与连接件的连接。
此外，输液套装可以被构造成倾斜的插入，其中插管能够基本上沿纵向轴线A或相对于轴线A稍成角度地从基部的第一端部或头部延伸，从而以本身已知的方式向患者提供能够倾斜插入的输液套装。该输液套装还可以被构造成当安装到患者的皮肤中时垂直于皮肤表面插入，其中插管从基部的下表面并且垂直于所述基部延伸。
当输液套装定位在患者的皮肤上时，例如垂直于患者的皮肤表面时，该输液套装覆盖针头插入位置。为了能够在不移除输液部件的情况下获得对插入位置进行清楚的观察，从输液部件的基部延伸的头部可设置有透明部分。该透明部分可以通过各种方式形成，例如用透明的聚丙烯铸造所述头部，或减小头部的厚度，或给所述头部设置放大区域以及类似方式。
这确保了对于插入位置的良好的和清楚的观察，从而能够检查所述插入位置，包括所述插入位置是清洁的并且没有被感染，以及插管在正确的位置定位到患者的皮肤中。
本发明的第二方面涉及一种包括注射器装置和根据本发明的输液套装的成套工具，其中所述注射器装置包括：壳体；柱塞，其可滑动地接收在所述壳体中以在推进位置和缩回位置之间运动，所述柱塞具有基本上不可拆卸地固定到该柱塞上的插入针头，所述插入针头用于在皮下输液套装的所述插管的位置上接收和支撑所述插管，其中所述插入针头能从插管上移除同时保持插管的经皮放置；驱动部分，其将柱塞从所述缩回位置推向所述推进位置以经皮地放置接收在所述插入针头上的皮下输液套装的插管。
上述成套工具设计成放置输液套装的插管，插入针头从插管中延伸穿过，以确保针头以给患者带来最低程度不适的方式适当地放置。注射器装置还可允许插入针头以选定的插入角度穿透皮肤来放置。在输液套装的启用和放置之后，注射器装置被移除并且开始输送药物。包括所述注射器装置和输液套装的所述成套工具通常作为无菌密封的一次性使用的组件提供给患者。
附图说明
接下来将参照附图对本发明进行更详细的描述：
图1示出了输液套装的实施例，其中输液部件和连接件被合为一体；
图2示出了图1中所示的输液套装的相同实施例的端视图；
图3示出了图1中所示的输液套装的相同实施例的侧视图；
图4示出了图1中所示的输液套装的相同实施例的俯视图；
图5示出了输液套装的实施例，其中输液部件和连接件被分开；
图6示出了图5中所示的输液套装的相同实施例的侧视图；
图7示出了图5中所示的输液套装的相同实施例的俯视图；
图8示出了基部上的保持装置的不同形状；
图8a示出了连接件上的连接件保持装置的不同形状；
图9示出了与本发明的输液套装一起使用的注射器装置的实施例。
具体实施方式
下面将参照示出本发明的实施例的附图对本发明作更详细的说明。
输液套装
图1-7描绘了用于穿透患者的皮肤间歇地施用治疗物质的输液套装的实施例，其中所述输液套装包括输液部件1和连接件2，所述连接件2通过导管14将输液部件1与医疗装置(未示出)连接起来，所述导管14延伸穿过连接件2中的开口19，如图2中所示。连接件2和输液部件1具有纵向轴线A，所述连接件2可沿所述纵向轴线A相对于输液部件1轴向地移动。
输液部件
在图5-7中能够清楚地看出，输液部件1包括具有主平面的基部3，当所述输液套装被附接到患者身上时，所述主平面基本上与患者的皮肤平行，所述基部具有第一表面10和第二表面11，所述第二表面11最靠近患者的皮肤并且设置有用于将输液部件1固定到患者皮肤上的第一固定器件和从基部3的所述第一表面(即所述主平面)延伸的头部6，所述头部6具有从基部3延伸进入患者皮肤中的插管12。在该实施例中，如图5-7所示，插管12从基部的第二表面11延伸，从而穿透所述第一固定器件。或者，插管12可以基本上沿轴线A从输液部件1的头部或基部3延伸，以便于插管12的倾斜插入。此外，输液部件包括用于将输液部件1和连接件2彼此相对定位的引导器件7，输液部件1的这些引导器件7被定位在头部6上。在图1，3和5中可以看出，基部3具有第一端部3a和相对的第二端部3b，第一端部3a是设置有头部6的端部，并且第二端部3b被定位成与第一端部3a相对。基部3可以被划分为三个部分，第一部分结合有第一端部3b并且通常被头部6覆盖，中间部分通常设置有针头插入开口4，并且结合有所述第二相对端部3b的最后的第三部分通常设置有保持装置8。如图4，5和7中所示，基部3还设置有位于头部6和保持装置8之间的开口9，当前的情形下为两个开口9。在该实施例中，这两个开口9与制造目的有关。
第一固定器件
在一个实施例中，如图9所示，第一固定器件可以是将输液部件1附接到患者的皮肤的安装垫21的形式，包括粘接层(未示出)和覆盖所述粘接层的可移除的释放衬垫22。通常所述粘接层为本身已知的不伤皮肤的粘接剂。所述安装垫可以是敷料、石膏、粘接垫或类似物，并且可以被构造成各种形状，诸如圆形、椭圆形、三角形、矩形等。
连接件
在图5-7中可以清楚地看出，当连接件2与输液部件1组装在一起时，连接件2具有与基部3的主平面平行并位于该主平面上方的平面。在该实施例中，如图1，4，5和7中清楚的描绘，所述连接件设置有两根臂15，该臂的第一端部2a被固定到连接件2，并且该臂的第二相对端部2b未固定且是自由的，从而臂15在第二端部2b处能够侧向地移动。当输液部件1和连接件2彼此相对地定位和组装时，连接件2的第二端部2b与基部3的第二端部3b对应。通过提供带有两根臂15的连接件2，当连接件2有意地与输液部件1断开连接时，可以更方便地获得对连接件2的良好的抓握和更好的控制。
在例如图5-7中可以看出，连接件2还设置有用于保护臂15的自由的第二端部2b的保护部件20，臂15在所述自由的第二端部2b处更灵活，并且因此在所述自由的第二端部2b处的接触更加敏感，以便不会偶然无意地释放或断开连接件2与输液部件1的连接。如上所述，连接件包括定位在第二端部2b中用于将输液套装连接到医疗装置的导管14。此外，所述连接件包括用于将输液部件1和连接件2彼此相对定位的引导器件16。连接件2可以关于连接件主平面以及关于垂直于所述主平面并且平行于主轴线的平面对称地形成，这将允许连接件2以两种方式与基部3配合。
流动路径
在图1-7中可以看到，输液部件1的头部6还设置有用于接收插入针头以便输液装置插入的插入针头开口4，和用于接收第二插管13的连接件开口5，其中第二插管13沿纵向轴线A从连接件2延伸。该插管13与从连接件2中的开口19延伸的导管14流体连接，其中所述导管14提供了与医疗装置例如胰岛素泵(未示出)的连接。在可替换的方式中，由于插入针头开口4用于软插管12的插入，因此如果插管12由金属制成，则头部6不需要设置有插入针头开口4。头部6设置有腔体(未示出)，该腔体适于接收插管12和第二插管13，所述插管12与所述腔体流体连通，并且沿纵向轴线A从连接件2延伸的所述第二插管13与导管14流体连通，即这里所用的腔体指的是插管的内腔或插管的延伸部。所述腔体被定位在头部6中的第一组引导器件7之间并且被基板的第一表面10限定，所述插入针头开口4以及选择地被膜片覆盖的连接件开口5(即未示出的所述腔体)适于接收从连接件2延伸的第二插管13。
在该实施例中，如图2，3和6中所示，插管12沿纵向轴线B从基部3的第二表面11延伸，从而被定位成与患者的皮肤垂直。在可替换的方式中，插管12能够基本上沿轴线A或相对于轴线A稍微成角度地从基部的第一端部3a或头部6延伸，以向患者提供以WO94/20160中所述的本身已知的方式倾斜插入的输液套装。
引导器件
如例如图5中所示以及如上文的输液部件和连接件部分中所述，输液部件1和连接件2中的每一个都设置有相应的引导器件7，16，用于使输液部件1和连接件2相对彼此定位和对准。所述引导器件可以是舌和槽机构的形式。所述舌和槽机构可以具有不同的结构和形状，例如可以是公/母(pater/mater)系统的形式或者所述舌和槽可以形成有三角形或半圆柱形的横截面区域。在该实施例中，输液部件1的第一引导器件7为关于基部3的主平面对称地设置的两个槽的形式，这些槽7适于与设置在连接件2上的第二组相应的引导器件16接合，在该实施例中，所述相应的第二引导器件16为两个舌或凸出部分的形式，例如配合在第一引导器件7中的稳定翼，从而所述引导器件7，16构成舌和槽系统。作为可替换的形式，输液部件1的第一引导器件7可以是突出翼的形式并且连接件2上的第二引导器件16可以是凹口或槽的形式。
第二固定器件-保持装置
输液部件1和连接件2设置有用于将连接件2固定到输液部件1的第二固定器件。例如如图5中所示，第二固定器件为定位在连接件2的臂15的自由端上的连接件保持装置17的形式，其适于与定位在输液部件1的基部3上的第二端部3b中的相应的保持装置8相接合。这样，连接件2被可释放地固定到输液部件1。
当输液部件1和连接件2被组装时，臂15的自由端，即第二相对的端部2b，定位成刚好与基部3的第二端部3b中的保持装置8相对或位于其上方。如图5-7中所示，该实施例中的保持装置8为从基部3的第一表面10延伸的用于将连接件2固定或保持到输液部件1上的两个保持装置8。在该实施例中，保持装置8放置在基部3的较远的后端上，即第二端部3b上，面朝后的臂15的连接件保持装置17类似地放置在所述面朝后的臂15的与保持装置8对应的较远的后端上，即第二端部2b上。
由于例如从连接件2中延伸出来的导管卡在某部件上，涉及拉动或牵引的意外产生该导管的倾斜运动，因此输液套装的超负荷经常发生，导致输液套装被无意地从患者皮肤上拉开。对于用户来说，其实质是在插入之后，即使发生涉及导管的拉动或牵引的意外，输液套装1、2的至少所述输液部件1仍保持就位。本发明符合这样的目的，因为所述连接件2的平面能够被倾斜成与基部3成一定距离，导致第二端部2b被移动比保持装置8的高度(h)更大的距离，当连接件2通过引导器件7，16相对于输液部件1进行定位时，所述保持装置8定位在基部3的第二端部3b中。随着连接件2的平面被移位，即相对于基部3倾斜，所述连接件的第二端部2b连同该连接件的臂15一起被提升，导致连接件保持装置17与保持装置8脱离。因此保持装置8和连接件保持装置17将彼此释放开，使连接件2与输液部件1断开连接，而不是输液部件1从患者的皮肤上脱离。
在本发明的实施例中，通过使连接件2绕引导器件7、16中的点枢转，连接件2的第二端部2b可以被移位到距基部3一定距离处，该距离比保持装置8的高度(h)大。
保持装置
如上所述，当连接件2通过引导器件7、16相对于输液部件1定位时，连接件2离开基部3的主平面的移位取决于保持装置8的高度和连接件保持装置17的高度(h)。保持装置8和连接件保持装置16的高度越低，将连接件2与输液部件1分离所需的第二端部2b离开基部3的主平面的移位距离越短。保持装置8的高度又取决于保持装置8和连接件保持装置17包括两个保持装置8、17的接触表面的形状。
在图8中描绘了保持装置8的不同形状。保持装置8形成有接触表面8a，用于与臂15的相应的连接件保持装置17的相对的接触表面17a接触，其中所述相对的接触表面17a可以在图8a中看到。保持装置8的接触表面8a从基部3的第一表面延伸。接触表面8a具有一平面，该平面具有与基部3的主平面垂直的投影高度(h)。在一个实施例中，当输液部件1和连接件2连接时，保持装置8的接触表面8a基本上垂直于基部3的主平面，即接触表面8a和基部3之间的角度大约为90°。然而，保持装置8的形式还可以是例如斜坡、斜槽、半圆、三角形或类似形状，其中接触表面8a相对于基部3的主平面成角度，即保持装置8的接触表面8a和基部3之间的角度α大于90°，如图8中所示。对于上面提到的保持装置8的每一种形状，垂直于基部3的主平面的投影高度(h)可以变化。通过这种方式，可以改变基部3上的保持装置8的高度，从而影响保持装置8和连接件保持装置17的两个接触表面之间的滑动，以确保当导管14被意外地拉动而产生倾斜运动时，连接件2与输液部件1断开连接。
除图8中所示形状之外的其他形状也可用于获得将连接件2与输液部件1断开连接所要求的或所需的保持装置8的高度。
连接件保持装置
如图8a中所示，连接件2的臂15的连接件保持装置17与保持装置8一样形成有相应的接触表面17a，其中该接触表面17a类似地可以形成为例如斜坡，斜槽，半圆，三角形和类似形状，其中三角形指的是当从侧面看去时所述保持装置成形为直角三角形或者保持装置具有直角三角形的横截面，该接触表面17a将臂15互锁或固定到基部3上的保持装置8。对于每个提到的连接件保持装置17的形状，垂直于连接件2的主平面的投影高度可以被改变。通过这种方式还可以改变连接件保持装置17的高度(h)并且影响保持装置8和连接件保持装置17的两个接触表面之间的滑动，以确保当导管14被意外地拉动而产生倾斜运动时，连接件2与输液部件1断开连接。
当输液部件1和连接件2组装时，保持装置8的接触表面8a和连接件保持装置17的接触表面17a彼此接合，从而确保连接件2和输液部件1的组装。因此，如果沿轴线A执行对导管14或连接件2第二端部2b的拖拉或牵拉，那么保持装置8和连接件保持装置17不会脱开接合。为了有意地将连接件2与输液部件1分离，必须紧握和按压连接件的臂15以沿连接件的主平面中的轴线并且垂直于轴线A移动臂。通过这种方式，臂15上的连接件保持装置17将脱离基部3上的保持装置8。
头部
当插管12被插入到患者的皮肤中并且插入角度与基部3的主平面垂直时，输液部件1的头部6通常将覆盖插入位置。通过使用透明材料，例如透光的聚丙烯(PP)来制成头部6，所述头部6能够用作窗口，使患者和用户能够清楚地看到插入位置。通过在输液部件1的头部6中提供透明部分或窗口，患者或用户因此能够保持观察插入位置并且随时确定插入位置或插入创口是否被感染，或插管12是否正确地定位到患者的皮肤中。
使输液部件1的头部6充分透明以获得良好的视觉效果和对被插入的插管进行清楚观察的另一种方式为，在铸造输液部件1之前对用于制造输液部件1的模具进行抛光。这使得模具光滑并且有助于使头部6的第一和第二表面都透明。作为另一种可替换的方式，可以铸造所述输液部件1并且随后抛光输液部件1的头部6。作为另一种可替换的方式，可以铸造输液部件1使头部6的第二表面上形成凹形，所述第二部分面对患者的皮肤，使得位于插入位置/创口区域上方的头部6的厚度减小或降低，从而提供了更好的透明特性和增大的穿透头部6的视野。作为再一种可替换的方式，可以将所述输液部件1制造为在头部6中嵌入放大区域或透镜，或者在成型过程中将透镜装配或安装在输液部件1的头部6中。这样，当透过头部6的所述放大区域或透镜观察时，可以产生插入位置/创口区域的放大的视图。
抓握器件
在实施例中，如图5-7所示，连接件2的臂10设置有凹槽形式的抓握器件18。所述抓握器件18是可选择的并且可以是凸边，槽，刻痕，凹槽以及粗纹的或粗糙的表面，可选择的是采用与连接件不同的材料。这样可以在用食指和拇指抓握和按压所述连接件2的臂以将连接件2与输液部件1固定或分离时保证更简单和方便的抓握。
材料/塑料
在另一实施例中，输液套装的输液部件1和连接件2由两种不同的塑料材料制成，例如两种不同类型的聚丙烯。当使用不同的材料制造所述输液套装时，可以增强用于每个部件的不同的特性。输液部件1通常非常小并且在使用过程中处于静止的位置，因此它应当具有光滑的表面和有限的柔性以向用户提供最佳的舒适感。连接件通常也非常小并且通常在使用过程中移动，因此连接件操作起来应当方便和舒适。输液部件和/或连接件可以主要由聚丙烯制成，例如透明的聚丙烯。这样，可以透过输液套装查看并且因此能够看到插管插入创口。
插管
插管12优选地为由热塑性弹性体(TPE)制成的软插管，所述TPE选自于由聚酯醚、ECDEL，苯乙烯基TPE，烯烃基TPE，聚氨酯基TPE，酯基TPE，酰胺基TPE，聚烯烃无硅橡胶(polyolefin sanssilicone rubbers)例如聚丙烯，C-FLEXTM，C-FLEXTM和聚丙烯的混合物，LUPOLENTM 1840H，LUPOLENTM 3020D，PELLETHANETM2362-75D，PELLETHANETM 2363-55D，TECOTHANETM和CARBOTHANETM构成的组，当然所述插管也可以由金属制成。
路厄(Luer)接头/医疗装置
连接件2可通过导管14连接到路厄联接元件。通过路厄接头，可以从泵施用适当的治疗物质，例如胰岛素。连接件还可以是一种具有用于注射器的插入针头的适当入口的闭合部件。这种闭合部件能够停留就位长达三天，同时用户可以使药物例如胰岛素通过所述入口注射，以减少由于重复的皮肤穿刺导致的皮肤创伤。
包括输液套装和插入装置的成套工具
在另一实施例中，本发明涉及一种系统或成套工具，所述成套工具包括注射器装置以及根据本发明的输液套装。所述注射器装置本身作为无菌密封的、一次性使用的组件提供给患者。所述注射器装置用于快速和方便地放置输液套装并且可以随后被安全地丢弃。
注射器装置
图10示出了可与根据本发明的输液套装一起使用的注射器装置的实施例。该注射器装置包括壳体23，在该实施例中，所述壳体包括用于确保柱塞25不会相对于壳体旋转的两个固定元件24。柱塞25可滑动地接收在壳体23中以便在推进位置和缩回位置之间运动，柱塞25具有基本上不可拆卸地固定到该柱塞上的医用插入针头(未示出)，其具有在所述插管12的位置接收和支撑皮下输液套装的插管12的尖端，其中所述插入针头可从插管12处移除同时保持插管12的经皮放置。
本申请中使用的基本上不可拆卸指的是这样一种连接，其将在正常使用条件下保持稳固，以便当从患者的皮肤中抽出注射器装置时，允许针头保留在柱塞25上。
注射器装置的壳体23还可以包括为两个突出部分形式的阻挡元件26，以将柱塞25保持在偏压位置上直到通过影响某些释放器件才将所述柱塞从所述偏压位置释放。柱塞25被构造成有中心部分25a和围绕部分25b。中心部分25a用作手指抓握部分，而围绕部分25b用作驱动部分。中心部分25a能够相对于壳体23在推进位置和缩回位置之间滑动，并且输液套装的输液部件1固定到中间部分25a。围绕部分25b被构造成两个部分，这两个部分差不多形成为两个半圆形，其中每个半圆形的一个端部附接到壳体23的固定元件24之一，而每个半圆形的另一端部固定到所述中间部分25a。半圆形的固定到壳体23固定元件上的端部在使用过程中不会相对于壳体23运动。半圆形的附接到中间部分25a的另一端部被拉出壳体23(在图10中用箭头表示方向)。当在中间部分25a拉动时，用作驱动部分的围绕部分25b将被张紧。所述围绕部分25b被两个突起27(只示出了一个)保持在偏置位置。突起27在该实施例中附接到连接壁28，但是其同样也可以附接到中心部分25a。当中心部分被从壳体23中拉出时，突起27将被拉动经过阻挡元件26并且这些元件将阻止突起27并且从而阻止中心部分25a返回到位于壳体23内部的非工作(relaxed)位置。
可通过沿着与由两个阻挡元件23形成的线垂直的线(图10中箭头所示的方向)按压壳体23的侧面而释放壳体23。当在该位置上从两个相对的侧面施压时，所产生的壳体的变形将引起两个阻挡元件26被彼此推离，从而留下足够的空间用于突起27经过所述阻挡元件26以及用于通过为围绕部分25b形式的驱动部分迫使中心部分25a返回到所述非工作位置。
插入针头可以在比如柱塞成型过程中通过任意适当的方式连接到柱塞25，或者插入针头可以被压配合在柱塞24中。插入针头可以被定向在与患者的皮肤成角度的位置处，从而实现垂直插入患者的皮肤和实现倾斜的插入。
壳体23可以具有圆形、方形或任意期望的横截面形状。壳体23和柱塞24有利地在成型过程中由塑料材料形成。
其他注射器装置
除本文描述的之外的其他注射器装置也可以与本发明的输液套装一起使用，但是需要能够配合输液套装的输液部件1并且能够将其保持就位直到执行插入。
手动地插入
无论输液套装是被手动地插入或是由注射器插入，所述输液部件1和连接件2都能够作为两个分离的单元交付给用户。在手动插入时，输液部件1与针头单元通过与连接件相同的锁定和引导器件相结合来交付。所述针头单元设置有插入针头，该插入针头从中前部延伸并伸出插管的端部，该插入针头在交付时延伸穿过所述中前部。所述针头单元唯一的功能将是穿透用户的皮肤，之后针头单元被移除并由连接件替代，使插管留在皮下。
其它医用装置
如上所述，连接件2可以通过导管14联接到用于施用治疗物质例如胰岛素的泵。然而，连接件2可以由假连接件或假部件替代，其中假部件的形状与连接件2对应，但是不具有位于连接件2的第二端部2b中的导管14。通过这种方式，患者可以断开真连接件2的连接并用所述假部件替代所述真连接件2，随后用于施用药物或治疗物质的泵将类似地与患者的输液套装断开连接。当患者携带所述假部件或假连接件并且需要药物或治疗物质时，例如，患者可以借助例如注射器通过输液部件1中的插入针头开口4将药物或治疗物质直接地注射到插管12中。
这样，对于患者来说可以更容易地在较短的时间段内离开房间而不会带来必须携带难操纵的医学设备(例如用于施用药物的上述泵)的不便，但是仍然能够通过使用例如小型注射器在需要时注射药物或治疗物质。
本发明是参照具体实施例加以描述的。但是在不偏离本发明的范围的情况下可以做出很多修改。

Claims (19)

1.一种穿过患者的皮肤间歇地施用治疗物质的输液套装，包括：
-输液部件(1)，其包括具有主平面的基部(3)、从所述基部(3)的所述主平面延伸的头部(6)和从所述基部(3)延伸进入患者皮肤的插管(12)，
-将所述输液部件(1)固定到患者皮肤的第一固定器件，
-连接件(2)，其具有与所述基部(3)的所述主平面平行并且位于所述主平面上方的平面，还具有一个或多个臂(15)，所述臂(15)的第一端部(2a)固定到所述连接件(2)并且相对的第二端部(2b)是自由的，定位在所述第二端部(2b)中的导管(14)用于将所述输液套装与一医疗装置连接，
-将所述输液部件(1)和所述连接件(2)相对彼此定位的引导器件(7、16)，
-将所述连接件(2)固定到所述输液部件(1)的第二固定器件，所述第二固定器件为定位在所述连接件(2)的所述臂(15)上的突出的连接件保持装置(17)的形式，所述连接件保持装置(17)用于与从所述基部(3)延伸的保持装置(8)相接合，
其特征在于：当所述连接件(2)通过所述引导器件(7、16)相对于所述输液部件(1)定位时，所述保持装置(8)定位在所述基部(3)的第二端部(3b)中并且与定位在所述连接件(2)的所述臂(15)的自由的第二端部(2b)处的连接件保持装置(17)对应，所述连接件(2)还设有用于保护所述臂(15)的自由的第二端部(2b)的突出的保护部件(20)。
2.根据权利要求1所述的输液套装，其中，所述连接件(2)包括沿着所述输液部件的纵向轴线(A)从所述连接件(2)延伸的插管(13)。
3.根据权利要求1或2所述的输液套装，其中所述输液部件(1)的所述插管(12)垂直于所述基部(3)的下表面(11)并且从所述基部(3)的下表面(11)延伸。
4.根据权利要求1所述的输液套装，其中所述输液部件(1)的所述保持装置(8)形成有与所述连接件保持装置(17)的相应接触表面(17a)相接合的接触表面(8a)，所述输液部件(1)的所述保持装置(8)的所述接触表面(8a)具有的一平面具有与所述基部(3)的主平面垂直的投影高度(h)。
5.根据权利要求4所述的输液套装，其中所述保持装置(8)的所述接触表面(8a)基本上垂直于所述基部(3)。
6.根据权利要求4所述的输液套装，其中当所述输液部件(1)与所述连接件(2)被组装时，所述臂(15)的所述连接件保持装置(17)的所述接触表面(17a)基本上垂直于所述基部(3)的所述主平面。
7.根据权利要求1所述的输液套装，其中所述第一固定器件为安装垫。
8.根据权利要求7所述的输液套装，其中所述安装垫为粘性敷料。
9.根据权利要求1所述的输液套装，其中用于将所述输液部件(1)和所述连接件(2)相对彼此定位的引导器件为舌和槽连接的形式。
10.根据权利要求9所述的输液套装，其中所述槽定位在所述输液部件(1)的所述头部(6)上，所述舌定位在所述连接件(2)上。
11.根据权利要求1所述的输液套装，其中所述输液部件(1)的所述头部(6)设置有透明部分。
12.根据权利要求11所述的输液套装，其中所述输液部件(1)的所述头部(6)由透明的聚丙烯制成。
13.根据权利要求11所述的输液套装，其中所述头部的透明部分通过减小所述头部(6)厚度的方式形成。
14.根据权利要求11所述的输液套装，其中所述头部(6)的透明部分设置有放大区域。
15.根据权利要求1所述的输液套装，其中所述连接件(2)的所述臂(15)设置有抓握装置(18)，用于在按压所述臂(15)使所述连接件(2)与所述输液部件(1)断开连接时容易抓握。
16.根据权利要求1所述的输液套装，其中所述输液部件(1)和所述连接件(2)由两种不同的塑料材料制成。
17.根据权利要求1所述的输液套装，其中所述输液部件(1)和/或所述连接件(2)实质上由聚丙烯制成。
18.根据权利要求1所述的输液套装，其中所述医疗装置为胰岛素泵。
19.一种包括注射器装置和根据权利要求1-17中任一项所述的输液套装的成套工具，其中所述注射器装置包括：
-壳体(23)，
-柱塞(25)，其可滑动地接收在所述壳体(23)中以在推进位置和缩回位置之间运动，所述柱塞(25)具有不可拆卸地固定到所述柱塞上的插入针头，所述插入针头用于在输液套装(1、2)的所述输液部件(1)的所述插管(12)的位置处接收和支撑所述输液部件(1)的所述插管(12)，其中所述插入针头能从所述输液部件(1)的所述插管(12)上移除同时保持所述输液部件(1)的所述插管(12)的经皮放置，
-驱动部分(25b)，其将所述柱塞(25)从所述缩回位置推向所述推进位置，以经皮地放置接收在所述插入针头上的所述输液套装(1、2)的所述输液部件(1)的所述插管(12)。
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US8012126B2 (en) 2011-09-06
RU2009120556A (ru) 2010-12-10
EP2089081A1 (en) 2009-08-19
MX2009004165A (es) 2009-05-01
JP2010508098A (ja) 2010-03-18
IL197957A0 (en) 2009-12-24
AU2007315380A1 (en) 2008-05-08
PL2089081T3 (pl) 2011-07-29
DK2089081T3 (da) 2011-02-28
EP2089081B1 (en) 2010-12-08
WO2008052545A1 (en) 2008-05-08
ATE490796T1 (de) 2010-12-15
KR20090078338A (ko) 2009-07-17
DE602007011101D1 (de) 2011-01-20
US20100022956A1 (en) 2010-01-28
RU2447907C2 (ru) 2012-04-20
CN101557845A (zh) 2009-10-14
NO20092119L (no) 2009-05-29
EP1917990A1 (en) 2008-05-07
CA2666744A1 (en) 2008-05-08

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