CN101951978A - 套管部件和流体路径之间的密封件 - Google Patents

套管部件和流体路径之间的密封件 Download PDF

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CN101951978A
CN101951978A CN2009801052176A CN200980105217A CN101951978A CN 101951978 A CN101951978 A CN 101951978A CN 2009801052176 A CN2009801052176 A CN 2009801052176A CN 200980105217 A CN200980105217 A CN 200980105217A CN 101951978 A CN101951978 A CN 101951978A
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S·吉尔恩
E·L·霍尔杜姆
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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
    • A61M5/14—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
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    • 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
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
    • 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
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
    • A61M2005/14252—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type with needle insertion means
    • 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
    • A61M5/14—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
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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
    • A61M5/14—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
    • A61M2005/1585—Needle inserters
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • A61M39/26—Valves closing automatically on disconnecting the line and opening on reconnection thereof
    • A61M2039/267—Valves closing automatically on disconnecting the line and opening on reconnection thereof having a sealing sleeve around a tubular or solid stem portion of the connector
    • 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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/1413—Modular systems comprising interconnecting elements

Abstract

本申请涉及一种输注部件，该输注部件包括套管部件(7)和流体路径，由此当套管部件处于使用位置时，密封件(18)布置在套管部件和流体路径的入口/出口开口(12)之间，以便使到套管的流体路径保持密封。密封件(18)包围入口/出口开口(12)，且/或套管部件的中心线c和布置在密封件(18)的上边缘处或上方的套管部件的外表面上的点之间的距离d1大于套管部件的中心线c和布置在密封件的下边缘处或下方的套管部件的外表面上的点之间的距离d2。

Description

套管部件和流体路径之间的密封件
技术领域
本发明涉及一种包括套管部件和流体路径的输注部件，该输注部件用来提供诸如胰岛素的治疗工作物质的连续给药。输注部件可连接到递送装置，该装置提供例如药物或营养物的受控制的剂量。
背景技术
WO 2007/071258描述了一种包括注射部分和流体递送部分的用来递送流体的医疗装置，其中流体递送部分和注射部分可以被分离和再连接。流体递送部分包括储器，例如以泵的形式的用于液体的运输的装置，和递送部分的活动单元放置在其中的外壳。注射部分包括：基板；套管部件，该套管部件包括具有贯穿开口的本体，设置有延伸过基板的近侧的套管；和用来将基板固定到用户的皮肤的装置，例如以安装垫的形式。套管部件设置有将流体引到套管部件中的空腔的一个或更多个开口并且每个开口覆盖有自封闭薄膜。递送部分和注射部分通过包括将流体从储器引到套管部件中的贯穿开口的流体路径的连接器被组装，该流体路径包括当连接器脱离递送部分和/或注射部分时用来堵塞到注射部分的通路的装置。在这个文献中示出的实施例是相当复杂的并且不容易制造。
EP 652027公开一种要放置在病人皮肤上用于药物的递送的输注装置。这种输注装置包括承载钢制的穿透套管的套管装置(10)。套管装置(10)是同心的，即套管装置的所有部分相对于绕共同轴线的旋转旋转对称。套管装置(10)可轴向滑动并且具有在圆柱形侧表面中带入口开口的通道(11)，该入口开口对应于通道(7)的出口开口，药物或类似物通过该入口开口进入。在通道(7)的出口的上方和下方放置有第一和第二O形环(8)。两个O形环(8)都放置在包围外壳(1)的内表面中的圆形凹槽中。在这种装置中，插入件和套管装置永久连接在一起，并且即使在已经发生套管装置的插入之前这也允许套管装置至少部分地插入紧密配合在套管装置周围的套管开口，即，这导致在整个插入程序期间在套管部件和外壳的内表面之间存在摩擦力。而且，在这个文献中，没有如何使软套管的使用适合这种装置的教导。
发明内容
本发明的目标是提供一种允许软套管的使用的输注部件，该输注部件是安全的且制造简单，并且该输注部件减小套管部件和基体部分之间的摩擦力且因此也减小在插入期间套管部件的不正确布置的风险。通过减小运动的套管部件和用来接收该套管部件的开口的内表面与从环境密封流体的衬垫接触的时间，实现这个目标。这大体上可通过产生具有递增直径的套管部件或通过产生具有较小面积的密封而实现。
这个目标通过包括套管部件和流体路径的如权利要求1中描述的输注部件实现，其中
套管部件包括由硬材料形成的本体，该本体具有与套管流体接触的内部贯穿开口，该套管具有提供与病人的流体接触的内部开口，套管部件的本体具有对应于流体路径的入口或出口开口的开口，导致流体路径和套管部件之间的流体接触，并且这些两个对应的开口当它们布置成彼此相对时允许不受限制的流动，
流体路径包括流体可通过其进入和离开流体路径的至少一个入口和一个出口开口，并且
当套管部件处于使用位置时，一密封件布置在所述套管部件和所述流体路径的入口/出口开口之间，以便使到所述套管的所述流体路径保持密封。
密封件包围入口/出口开口，且/或套管部件的中心线c和布置在密封件的上边缘处或上方的套管部件的外表面上的点之间的距离d1大于套管部件的中心线c和布置在密封件的下边缘处或下方的套管部件的外表面上的点之间的距离d2。当根据本发明的输注部件插在使用位置中时，“密封件的上边缘”限定到病人的皮肤具有最长距离的密封件或衬垫的部分，并且“密封件的下边缘”限定到病人的皮肤具有最短距离的密封件的部分。
根据一个实施例，套管部件的本体在使用之前设置有密封件，或者替代地，流体路径的开口或包围流体路径的开口的表面在使用之前设置有密封件。“设置”意指密封件或衬垫稍微附接到指示的表面，它可能仅仅放置在凹槽或腔中，如图9或10中指示的。
根据一个实施例，穿透构件设置有保证在插入之后穿透构件以不可释放的方式附接到基体部分的附接装置。
根据一个实施例，套管部件的本体设置有密封件或衬垫，该密封件或衬垫沿流体通过其进入或离开套管部件的开口的边缘放置。
根据一个实施例，对应于套管部件的开口的流体路径的开口设置有密封件，该密封件沿该开口的边缘放置，即以离开开口的短的距离放置。“短的距离”被理解为小于或等于等于开口的直径的距离，并且如果开口不是圆的，则小于或等于开口的最长尺寸。
根据任何实施例的密封材料可以是疏水的且弹性的，例如密封材料由硅树脂制成。
根据实施例，套管部件的本体具有到内部贯穿开口的至少一个第二开口，并且优选地到内部贯穿开口的这个至少一个第二开口由自封闭薄膜覆盖，该薄膜能被钝的或尖的针穿透并且可由硅树脂制成。
如果套管是不能自身穿过病人皮肤的软套管，则这个至少第二开口可以例如用于所述装置的插入，然后分离的插入针可穿过第二开口、贯穿套管并且在套管的前部提供切割边缘。它也可以用于供应药物或营养物，该药物或营养物仅仅以较小的剂量每天数次给予病人。
根据实施例，输注部件包括可被紧固到病人的皮肤的基体部分。
根据这种输注部件的一个实施例，基体部分设置有对应于套管部件的非穿透端部处的轮廓的开口。
套管部件的“非穿透端部”是与套管相对的端部，即穿透构件的远端，其中“远”表示背离病人的端部。在图4A、4B和4C中示出的套管部件的实施例中，套管部件在对应于包围流体路径的开口的平坦壁的一侧上具有平坦表面部分，即开口是“适合的”意指周围壁对应于套管部件并且保证套管部件终止于严格限定的且紧密配合的(优选地压配合的)位置。“压配合”意指它是如此紧密配合以至于需要力来插入套管部件。
根据这个实施例，该开口可以在提供壁的基体部分的外表面下方延伸，当套管部件插入病人时该开口紧密配合在套管部件周围，并且优选地流体路径的入口或出口开口通向配合在套管部件周围的开口的壁，并且当插入套管部件时，到套管部件的内部开口的入口或出口对应于流体路径的入口/出口开口。
根据一个实施例，套管部件的中心线c和布置在密封件的上边缘处的套管部件的外表面上的点之间的距离d1大于套管部件的中心线c和布置在密封件的下边缘处的套管部件的外表面上的点之间的距离d2。中心线c平行于插入方向。
根据一个实施例，角度d是套管部件的插入方向和与包围与密封件相对的开口的表面相切的平面之间的角度，并且0＜d≤90°，通常45≤d≤80°，并且最经常地70≤d≤80°。
当具有递减横截面的套管部件插入具有对应递减空腔的空腔时，则套管部件可压配合到该空腔中。这种压配合保证流体路径和套管部件各自的两个对应开口被压在一起，因此改善它们之间的流体密封连接，并且它也可以将套管部件锁定到基体部分。
根据一个实施例，基体部分至少部分地由硬材料形成。材料是“硬的”意指它不能被针穿透，并且它也能够维持在生产期间给予它的形状，虽然可能由于给予它的形状而挠曲该材料，例如，如果它形成为薄板或者如果它非常长，而又不可能压缩它即减小它的尺寸。
根据一个实施例，流体路径形成为紧固到病人的皮肤的基体部分的一体化部分。流体路径形成为一体化部分意指它是该装置的不可释放部分，即在基体部分的制造过程期间的一些时候它永久附接到该装置，并且当基体部分在使用中时将不可能分离流体路径和基体部分的其余部分。
根据一个实施例，硬材料是模制塑料，例如该塑料是聚丙烯。
根据一个实施例，基体部分包括用来将递送装置附接到基体部分的紧固装置。递送装置可包括连接部分，该连接部分设置有对应于用于递送装置的紧固装置的装置并且设置有用来将药物传递到输注部件的管，或者递送装置可包括包含药物的储器和用来将药物传递到输注部件的装置。用来传递的装置通常将是泵和可能地与传感器组合的可编程部分，该可编程部分用来保证适当量的药物被递送到病人。
附图说明
现在将参考附图描述本发明的实施例，其中：
图1示出根据本发明的输注部件的第一实施例。
图2和2A示出根据本发明的输注部件的第二实施例。
图3示出如图2和2A的输注部件的相同实施例。
图4A、4B和4C示出可以结合本发明使用的套管部件。
图5示出可以结合本发明使用的插入件的前视图。
图6示出从图5的插入件的近侧的视图。
图7示出可以是根据本发明的输注部件的一部分的连接器部分。
图8示出没有覆盖入口的气泡薄膜的与图7相同的连接器部分。
图9A和9B示出具有倾斜的接触表面的套管部件。
图10A-10D示出套管部件和连接部分的套管开口之间的接触的放大图。
图11A、11B和11C示出设置有主要由管构成的流体路径的基体部分的实施例。
图12示出在插入方向和接触表面的切线之间具有角度d＝90°的输注部件的实施例。
图13示出可以结合本发明使用的套管部件。
具体实施方式
图1示出根据本发明的包括套管部件和流体路径的输注部件的实施例。这个实施例包括附接到接触表面的表面板1。在这个实施例中，表面板1由模制的塑料材料构成并且接触表面可以是安装垫2的近侧，在该装置的制造期间，该安装垫2以不可释放的方式紧固到表面板1。这个实施例的安装垫2具有与表面板1相同的面积，但它可以具有大于或小于表面板1的面积。
连接器部分3布置在表面板1上。连接器部分3提供基体部分和一些种类的递送装置之间的接触。根据一个实施例，在该装置的制造期间，表面板1和至少连接器部分3的外覆盖件仅仅模制成单一件。连接器部分3的内部部分在例如药物的储器6或用于从病人收集的液体的储器和套管部件7之间形成流体路径。因此，连接器部分3设置有至少两个开口，在流体路径的每个端部有一个开口，其中第一开口13是接收流体或递送流体到未示出的储器的入口或出口开口，并且第二开口是接收流体或递送流体到套管部件7的入口或出口开口12。连接部分3可设置有额外的开口，例如，用于插入套管部件，用于第二药物或营养物的注射或用来使流体路径中的流体与传感器接触。
在下面，第一开口13将称为入口并且第二开口将称为出口，虽然通过流体路径的流动的方向对本发明不重要。
图1的实施例设置有以两个直角L形轮廓的形式(以
Figure BPA00001200239600061
的形式)的两个引导装置4，该轮廓从下或近侧紧固到病人的皮肤的基体部分的表面板1突出。引导装置4对应于在使用期间要紧固到基体部分的递送部分或覆盖件或连接装置上的引导装置。这种对应装置可以例如形成为具有对应于基体部分上的轮廓的以
Figure BPA00001200239600062
的形式的L形轮廓的一个或更多个钩。
这个实施例的连接部分3的流体路径很短且连接部分3的入口13放置在相对于引导装置4的中心位置中。插入的套管部件7的顶部被示出为插入到连接部分3中。
连接部分3还设置有套管腔12A，该套管腔精确地配合在套管部件7的周围，即套管腔12A具有与套管部件7相同的三维形状或轮廓并且正好足够大以使套管部件7穿过并且随后配合到该开口中。在图1中，套管部件7被示出为处于套管部件7完全插入的位置中。当套管部件7完全插入时，则上表面，即套管部件7的远端表面通常与套管腔12A周围的连接部分3的外表面齐平或处于比该外表面低的水平。
当套管部件7已经完全插入到连接部分3中时，套管部件7的本体24的侧表面中的开口20对应于连接部分3的流体路径的开口12并且流体可从一个部分流到另一个部分。开口12在下面可称为出口，虽然流动的方向对本发明不重要。
图2和3示出根据本发明的输注部件的第二实施例。对应于这个实施例的递送部分可通过向着引导装置4推下递送部分而连接到基体部分，该引导装置在这种情况下是具有紧固到顶表面的磁体5的纵向隆起的平台。该递送部分将设置有例如比磁体5小或不同于磁体5的尺寸的对应磁体，该磁体放置成(例如在对应于隆起的平台4的轨道中)使得递送部分的对应磁体可沿纵向沿着基体部分的隆起平台4上的磁体5滑动。当递送部分到达其工作位置时，两个释放把手可分别与从表面板1的上表面突出的两个突出部分15接合。当递送部分处于其工作位置时，它沿任何水平方向被释放把手锁定并且沿垂直于表面板1的方向被两个对应的磁体锁定，该两个对应的磁体分别属于递送部分和基体部分。这些锁定机构使得可以如需要的那样经常紧固和从基体部分释放递送装置，即单用途基体部分可以与多用途递送部分组合。
在图2和2A中基体部分被示出为没有套管部件7，并且在图3中基体部分被示出为具有套管部件7，该套管部件在恰好在套管部件7的插入之前达到的位置中，通常，套管部件7将在插入的这个阶段仍然放置在插入件内并且它将不可见。
通常，插入件10在插入之前保持套管部件7并且该插入可通过推把手11而被起动。图5和6示出必须推入把手11以便起动套管部件7的插入的方向。在插入之后，未示出的插入针可以缩回到插入件10的内部，并且从基体部分移除插入件10，留下紧固到表面板1的插入的套管22。如果套管部件7的套管22是硬的自穿透套管，则将不存在分离的插入针并且因此不需要缩回插入针。
在图2和2a中，连接部分3被示出为具有由模制的表面板1提供的外部覆盖件。这个实施例中示出的外部覆盖件不是独立单元而是以不可释放的方式附接到表面板1或例如通过模制过程仅仅制造为表面板1的一部分。外部覆盖件设置有用于套管部件7的套管腔12A和用于例如储器的通路开口13，因此允许通过储器和套管部件7接近连接部分3的流体路径。套管腔12A允许套管部件7在硬表面板1的周围内皮下地或经皮地插入到病人中，并且在这个实施例中由安装垫提供的基体部分的接触表面2也设置有允许套管插入的开口12B(见图7和8)。如果接触表面2由使其可被至少套管部件7的套管22穿透的材料和厚度构成，则这个开口12B不是必要的。
在图7和8中，连接部分3被示出为没有由模制的表面板1提供的外部覆盖件。为了保证连接部分3中的出口开口12和套管部件7之间的流体密封的连接，连接部分3的出口开口12在出口开口12的周围设置有弹性密封件18。当套管部件7插入时，它将压配合到套管开口12中，并且弹性密封件18将在对应的开口12和20周围提供完全流体密封的衬垫。为了改善压配合并因此改善套管部件7和流体路径的出口之间的流体密封连接，套管腔12A可在当插入时平行于套管22且垂直于布置流体路径的出口的表面的平面中设置有递减的横截面。套管部件7将具有对应的递减横截面。
为了保证连接部分3中的入口开口13和储器6之间的流体密封的连接，气泡形薄膜17已经布置在第一开口13周围。薄膜17完全覆盖入口开口13并且防止连接部分3的内部的污染。当储器或用于储器的连接部分被压向连接部分3时，连接器针19将穿透薄膜17并且在连接部分3和储器之间提供完全流体密封的流体传递。
薄膜17是气泡形的意指它附接在它所保护的开口周围(通常在开口的边缘周围)，并且薄膜17从开口的边缘形成的平面突出并且在离开边缘一定距离处形成圆顶，该距离通常对应于连接器针19的长度。
在图8中，连接器针19被示出为连接部分3的一部分，即它附接到连接部分3但它同样可以是储器的一部分。
根据一个实施例，连接部分3设置有连接器针19和气泡形自封闭薄膜7，并且储器也设置有气泡形自封闭薄膜。由于两个部分都设置有自封闭薄膜，因此将可以使该两个单元彼此分离并且在以后再连接它们而不污染连接部分3的内部流体路径且因此不污染病人。
图4A、4B和4C示出可以结合本发明使用的套管部件7的放大图。这个实施例包括本体24，该本体设置有套管22且设置有具有平坦表面的突出前部25。具有开口的套管部件7的表面不需要是平坦的；它实际上可以具有任何希望形状，只要它可以产生面向套管部件7的连接部分3上的对应表面。在一个实施例中，前部25倾斜使得上端，即远端处的横截面在至少一个尺寸上大于前部的近端(即在插入后最靠近病人的端部)处的横截面。前部25设置有开口20，液体可通过该开口离开或进入套管部件7。本体24还设置有顶开口21，该开口可覆盖有自封闭薄膜。由于开口21面向与环境接触的外表面，因此开口21需要一些种类的进入保护。如果套管22是软套管，则当插入套管部件7时主要使用顶开口21。套管22是软的意味着它由不能穿透病人皮肤的相对软的材料制成，在这种情况下，当插入套管时有必要使用相对硬的材料的尖的插入针，并且这个尖的针可以通过顶开口21、穿过套管部件的本体24中的内部贯穿开口并且还穿过套管22的全长度插入，使得插入针的尖的端部伸出空心套管22的敞开端部。在插入之后，即在套管22已经皮下地或经皮地放置在病人体内之后，则缩回插入针且套管22留在病人体内。
套管部件7也设置有紧固装置23，该紧固装置23在它完全插入时将套管部件7锁定到基体部分。这个实施例的紧固装置23包括向外的钩，该钩可以绕接近套管部件7的本体24的轴线枢转使得当向内，即向着套管部件7的中心压钩时钩的最外边缘形成的直径可以减小。当移除压力时，钩将由于材料的挠性而返回它们的初始位置。当钩经过开口(例如开口12B或表面板中的对应开口，其横截面至少在一个尺寸上小于钩的外边缘)时，将向内推钩，并且在钩已经穿过开口之后返回到它们的初始位置时，钩将套管部件7锁定在插入位置中。
图5和6示出可用于将套管部件7布置在基体部分中的插入件。插入件包括设置有内部开口的外壳10，套管部件7可在该内部开口中从缩回位置运动到向前位置。在缩回位置中，套管22不与病人接触，并且在向前位置中套管22插入病人中。插入件还包括致动器把手11，该致动器把手当要插入套管部件7时被触发，并且它包括紧固装置14，该装置可在插入之前和在插入期间将插入件锁定到基体部分。通常，插入件应当在无菌条件下紧固到基体部分，或者连接的基体部分和插入件应当在插入件的紧固之后被消毒，以便防止套管腔12A的污染，并且以便减小放置在病人的皮肤上的材料的量。希望的是，在套管部件7已经插入之后能够移除插入件的整个或至少一部分。
图9A和9B示出套管部件7的第二实施例的放大图。图9A示出处于恰好在插入前的状态的套管部件7，并且图9B示出插入到基体部分中的腔12A中的套管部件7。
这个实施例也包括本体24，该本体设置有套管22且设置有突出前部25，该突出前部具有设置有开口20的平坦表面。根据这个实施例，突出部分25倾斜使得开口20和连接部分3的第二开口12周围的密封件18之间的压力增加，而且密封件18在插入期间受到较小撕力。倾斜部分25的倾斜由套管22的中心线c(中心线c平行于插入方向)和平行于开口20周围的表面的线之间的角度d限定。如果开口20周围的表面不是直的，则平行于该表面的线将与开口20周围的表面相切。角度d将大于0°且小于或等于90°，通常，取决于密封件18的直径或突出，d∈[0°°]，或者[60°，90°]。在突出倾斜部分25的表面的远端(其中该远端是在插入之后套管部件7的最远离病人的端部)测量到的突出倾斜部分25的表面和套管部件7的中心c之间距离d1大于近端(即插入之后最靠近病人的端部)处的突出部分25的表面和套管部件7的中心c之间的距离d2。通常，距离d2将如此小以至于突出倾斜前部25的近端在插入期间不接触连接部分3的密封件18。
在一个实施例(未示出)中，角度d接近90°，即d＝90°，这种实施例将在对应于图9A和9B的图中看起来具有配合到套管部件7的向下开口20的连接部分3的向上开口12。这意味着将套管部件7推向密封件18的力将接近垂直于密封件18的接触表面并且这将通过套管部件7沿密封件18滑动防止密封件在套管部件7的插入期间扭曲。
在另一实施例(在图4A-C中和在图10A-B中示出)中，由于突出部分25和中心线c是平行的，d＝0°。根据这个实施例，套管部件7将与突出密封件18滑动接触，这可引起密封被扭曲。
套管部件7的突出前部25不需要是平坦的；它实际上可以具有任何希望形状，例如部分球形，只要它可以产生面向套管部件7的连接部分3上的对应表面。而且，取决于套管部件7的目的，突出前部25的开口20可以相当于入口或出口。在为剖视图的图9A和9B中示出本体24的顶开口21如何覆盖有自封闭薄膜21A。如根据图4A-4C的实施例，如果套管22是软套管，则当插入套管部件7时主要使用顶开口21，但顶开口21也可用于注射除了主要药物外的药物或营养物，该主要药物可以是例如胰岛素，病人通过开口20接收该胰岛素。
套管部件7的这个实施例也设置有紧固装置23，并且在这个实施例中紧固装置23具有套管部件7上的突出部分23的形式，该突出部分23对应于静止的基体部分上的挠性部分23A。在套管部件7的插入期间当套管部件7上的突出部分23经过时，如在图9A由箭头指示的，可以向外推挠性部分23A。在插入之后，套管部件7的突出部分23的向上表面将被基体部分的挠性部分23A的向下表面锁定并且将不可能从基体部分分离套管部件7。
图9A和9B的套管部件7设置有软套管22，该软套管22与衬套29一起提供套管组件。这个组件通常通过干涉配合紧固在套管部件7的本体24内，即仅仅本体24和套管组件之间的摩擦力将其保持在正确位置中。为了防止套管组件通过套管部件7的本体24中的上部较大开口滑回去，套管部件7的本体24可设置有围绕用于软套管22的出口的环形凹坑。由于凹坑在软套管22周围产生敞开空间，因此软套管22可形成防止软套管滑回去的小的块，即环形块。
图10示出具有本体24的套管部件7和具有入口/出口开口12的流体路径之间的不受限制的开口如何滑动到适当位置中。图10A和10B示出d＝0°的实施例，且图10C和10D示出d为大约15°，通常在8-22°之间的实施例。根据图10A和10B的实施例，套管部件7的本体24设置有倾斜边缘以便减小密封件的扭曲或撕开。在两个实施例中，示出的密封件18都是圆形或圆柱形硅树脂单元，该硅树脂单元放置在连接部分3中的入口/出口开口12周围的圆形轨道中。已经放置密封件或衬垫18的壁设置有邻近的膨胀室28。在布置套管部件7之后，密封件18可占据这个室。在图10C和10D的实施例中，不仅密封面是倾斜的，而且整个圆柱形密封部分18是倾斜的，以便允许均匀的密封变形。圆柱形密封18不形成入口/出口开口12的壁，这个开口的壁或表面由形成连接部分3的材料形成以便提供不能变形的管道。为了在密封件和密封面(即当处于密封位置时密封件18接触的表面)之间产生必要的压力，密封面可设置有小的连续突出，该连续突出从密封面突出并且具有与密封件相同的形状，如果密封件具有图10A-D中示出的圆柱形形状，则它将是例如圆形的。
图11A-11C示出连接部分3的一个实施例。图11A以分解视图示出连接部分3的实施例，其中示出提供流体路径的管60的内部保持部分61。图11B示出穿过内部保持部分61的剖面，根据该内部保持部分可以到达管60的位置。图11C示出图11A的被包围部分的放大图。
根据本实施例，连接部分3和表面板1模制成塑料材料制成的单一件，连接部分设置有数个开口，一个开口是准备用来配合在套管部件7中的腔12A并且另一个开口准备用来配合在连接部分3的内部部分中。根据这个实施例的连接部分3的内部部分包括一个管，该管在两个位置以90°弯曲，即管60的入口和出口端部都沿垂直于管60的连接部分的相同方向指向，其中管60的连接部分在两个弯曲部分之间形成流体路径。
在一个端部，管60由气泡形薄膜17保护，并且在另一个端部，管60是敞开的且不受保护，但敞开的管端部由以不可释放的方式附接到保持部分61的密封件18包围。当内部部分已经放置在连接部分3中的对应的开口中时，精确地配合在该开口中的覆盖件62被放置成与连接部分3的表面齐平，使得用户体验不能被窜改的光滑表面。
图11A中示出的基体部分的实施例设置有引导装置26，该引导装置放置在连接部分3的腔12A内。构成引导装置的两个相对的肋26对应于套管部件7中的紧密配合的开口27。引导装置26和套管部件上的对应部分27可具有其它形式，重要特征是它们彼此对应并且使得套管部件7可以滑动到使用位置中。
图11B示出连接部分3的内部部分的放大图。保持部分61包括单个模制部分，该单个模制部分提供管60的稳定嵌入。管60的敞开端部通向由密封件18包围的空间。管60的封闭端部由软薄膜完全包围。“完全包围”意指没有到环境的自由通路，“软薄膜”意指薄膜可以由特别是连接器针19的针穿透，该连接器针由管60的端部提供并且该连接器针嵌在软薄膜内。构成连接器针19的管60的端部在这个实施例中实际上不与周围的薄膜17接触。连接器针19由空气包围，并且包围连接器针19的内部空间具有圆柱形或圆锥形形状，即圆形横截面。当薄膜的长度由于施加的压力而减小时，薄膜17的壁将通过向内或向外弯曲而变形。
图11C示出图11A中标记的封闭区域的放大图。
图12示出输注部件的实施例，其中角度d＝90°。入口/出口开口12构造为提供储器6和套管部件7之间的流体路径或连接的管60的尖的端部。例如自封闭的薄膜保护到储器6的进入，这意味着当从连接部分3移除储器时微生物不能接近储器6。
图13示出可以与根据权利要求1的输注部件一起使用的套管部件7的又一实施例。套管部件7的本体24具有截头圆锥的形状或轮廓，即在本体的每个水平(根据图13)横截面中，它是具有变化直径的圆形。本体24设置有两个永久附接的圆形密封件或衬垫18。在这两个衬垫18之间布置开口20，该开口20允许流体通过套管部件7的贯穿开口进入内部。套管部件7要放置在下面示出的设置有对应的腔12A的连接部分3中，该对应的腔也具有截头圆锥的形状。腔12A具有入口/出口开口12以便流体流动到套管22或从套管22流动。

Claims (15)

1.一种包括套管部件(7)和流体路径的输注部件，
所述套管部件(7)包括由硬材料形成的本体(24)，所述本体(24)具有与套管(22)流体接触的内部贯穿开口，所述套管(22)具有提供与病人的流体接触的内部开口，所述套管部件(7)的本体(24)具有对应于所述流体路径的入口或出口开口(12)的开口(20)，导致所述流体路径和所述套管部件(7)之间的流体接触，并且这两个对应的开口(12，20)当它们被布置成彼此相对时允许不受限制的流动，
所述流体路径包括至少一个入口和一个出口开口(12，13)，流体能通过该至少一个入口和一个出口开口(12，13)进入和离开所述流体路径，并且
当所述套管部件(7)处于使用位置时，密封件(18)布置在所述套管部件(7)和所述流体路径的入口/出口开口(12)之间，以便到使所述套管的所述流体路径保持密封，
其特征在于，所述密封件(18)包围所述入口/出口开口(12)，且/或所述套管部件的中心线c和布置在所述密封件(18)的上边缘处或上方的所述套管部件的外表面上的点之间的距离d1大于所述套管部件的中心线c和布置在所述密封件(18)的下边缘处或下方的所述套管部件的外表面上的点之间的距离d2。
2.根据权利要求1的输注部件，其特征在于，所述套管部件(7)的本体(24)在使用前设置有密封件(18)。
3.根据权利要求1或2的输注部件，其特征在于，所述流体路径的开口(12)在使用前设置有密封件(18)。
4.根据权利要求2或3的输注部件，其特征在于，所述密封件(18)的材料是疏水的且弹性的。
5.根据权利要求4的输注部件，其特征在于，所述密封件(18)的材料是硅树脂。
6.根据权利要求1-5中的任一权利要求的输注部件，其特征在于，所述套管部件(7)的本体(24)具有到所述内部贯穿开口的至少第二开口(21)。
7.根据权利要求6的输注部件，其特征在于，到所述内部贯穿开口的所述第二开口(21)由自封闭薄膜覆盖，所述薄膜能被钝的或尖的针穿透。
8.根据权利要求1-7中的任一权利要求的输注部件，其特征在于，所述输注部件包括能紧固到病人的皮肤的基体部分(1，2，3)。
9.根据权利要求8的输注部件，其特征在于，所述基体部分(1，2，3)设置有对应于所述套管部件(7)的非穿透端部的三维轮廓的腔(12A)。
10.根据权利要求9的组件，其特征在于，所述腔(12A)在提供壁的所述基体部分(1，2，3)的外表面下方延伸，当所述套管部件(7)插入病人时，该腔(12A)紧密配合在所述套管部件(7)周围。
11.根据权利要求10的组件，其特征在于，所述流体路径的入口/出口开口(12)通向配合在所述套管部件(7)周围的所述腔(12A)的壁，并且当插入所述套管部件(7)时，所述套管部件(7)的开口(20)对应于所述流体路径的开口(12)。
12.根据任一前述权利要求的组件，其特征在于，所述套管部件(7)的插入方向和与包围与所述密封件(18)相对的开口的表面相切的平面之间的角度称为d且0＜d≤90°。
13.根据权利要求8-12中的任一权利要求的输注部件，其特征在于，所述基体部分(1，2，3)至少部分地由硬材料(1，3)形成。
14.根据权利要求8-13中的任一权利要求的输注部件，其特征在于，所述流体路径形成为所述基体部分的一体化部分。
15.根据权利要求13或14的输注部件，其特征在于，所述硬材料是模制的塑料材料。
CN2009801052176A 2008-02-13 2009-02-12 套管部件和流体路径之间的密封件 Pending CN101951978A (zh)

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AU2009214047A1 (en) 2009-08-20
NZ587111A (en) 2012-03-30
RU2010137844A (ru) 2012-03-20
IL207221A (en) 2011-11-30
IL207221A0 (en) 2010-12-30
BRPI0907715A2 (pt) 2017-06-13
US20210283331A1 (en) 2021-09-16
PL2252349T3 (pl) 2012-01-31
US20110034883A1 (en) 2011-02-10
ATE522240T1 (de) 2011-09-15
WO2009101130A1 (en) 2009-08-20
CA2713485A1 (en) 2009-08-20
PT2252349E (pt) 2011-11-23
EP2252349B1 (en) 2011-08-31
EP2252349A1 (en) 2010-11-24
JP2011511688A (ja) 2011-04-14
KR20100123711A (ko) 2010-11-24
US10898643B2 (en) 2021-01-26
ES2371323T3 (es) 2011-12-29
DK2252349T3 (da) 2011-10-10
MX2010008759A (es) 2010-08-31

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