A METHOD FOR STERILIZATION OF A FLUID PATH FOR AN INJECTION DEVICE

    公开(公告)号:EP3348284A2

    公开(公告)日:2018-07-18

    申请号:EP17151131.4

    申请日:2017-01-12

    IPC分类号: A61L2/20

    摘要: A method for sterilizing a fluid path unit (25) for an injection device comprising the steps of:
    a) Providing an empty cartridge (26) having a glass barrel (125) and a septum (27) connected to the distal end of the glass barrel (125) using a crimp (27a),
    b) Providing a fluid path comprising a spike (31) adapted for piercing the septum of the cartridge (126) and a needle (36) adapted for piercing the skin of a patient, the spike (31) and needle (36) being interconnected preferably by a tubing (43).
    The fluid path unit (25) furthermore has a first cavity (127) encapsulating the spike (31) and the needle (36) and a second cavity (128) adapted to receive the distal end of the cartridge (126), the first and second cavity being connected to each other and having a passage (130) there between adapted to receive the spike (31) of the fluid path. The following steps are also part of the sterilization method:
    c) Inserting the empty cartridge (26) into the second cavity (128) of the fluid path unit (25),
    d) Fixating the empty cartridge (26) to the fluid path unit (25),
    e) Sterilizing the first cavity (127) of the fluid path unit,
    And the method is characterized by that the empty cartridge (26) having a glass barrel (125) and a septum (27) connected to the distal end is provided with a sterile interface (126) between the glass barrel (125) and the septum (27) and that in step f) the empty cartridge (126) is filled with a medicament (134) after step e).

    INJECTION DEVICE WITH A NEEDLE CANNULA
    4.
    发明授权
    INJECTION DEVICE WITH A NEEDLE CANNULA 有权
    具有针管的注射装置

    公开(公告)号:EP3062836B1

    公开(公告)日:2018-04-25

    申请号:EP14781911.4

    申请日:2014-10-10

    申请人: Novo Nordisk A/S

    IPC分类号: A61M5/00 A61M5/32 A61M5/24

    摘要: The present invention relates to an injection device for injecting a pharmaceutical liquid drug containing a preservative. The injection device comprises a housing (1) supporting a cartridge (20) having an interior chamber (21) holding the pharmaceutical preservative containing liquid drug to be injected, and a needle cannula (10) having a front part (11) and a back part (12), which back part (12) is adapted to be in liquid communication with the interior chamber (21) of the cartridge (20). The injection device is further provided with a telescopic needle covering shield (30) which distally is provided with a reservoir (31) which holds a liquid containing the same preservatives as in the pharmaceutical preservative containing liquid drug contained in the interior chamber of the cartridge. The telescopic needle covering shield (30) is telescopic movable in relation to the needle cannula (10) by a first resilient member between a first position and a second position. In the first position, the tip (13) of the front part (11) of the needle cannula (10) is maintained inside the reservoir (31), and in the second position, the tip (13) of the front part (11) of the needle cannula (10) is located outside the reservoir (31) and distally to the reservoir (31). The tip (13) of the needle cannula (10) is thus cleaned by the preservatives in the reservoir (31) between subsequent injections.

    NEEDLE ARRANGEMENT
    5.
    发明授权
    NEEDLE ARRANGEMENT 有权
    针布置

    公开(公告)号:EP3125974B1

    公开(公告)日:2018-01-31

    申请号:EP15711788.8

    申请日:2015-03-25

    申请人: Novo Nordisk A/S

    IPC分类号: A61M5/32 A61M5/34 A61M5/00

    摘要: The present invention relates to a needle arrangement for an injection device. The needle arrangement is made up from needle cannula which is mounted such that a distal part having a distal tip extends in a distal direction. Further, a telescopically movable shield carrying a cleaning chamber surrounds at least the tip of the needle cannula between injections such that the tip of the needle cannula is maintained inside the cleaning chamber between subsequent injections. The cleaning chamber is at least distally provided with a pierceable septum through which the needle cannula penetrates during injections. For guiding the needle cannula during injections a telescopically movable tube is provided. During injections the distal end of the telescopically movable tube at least partly penetrates the distal septum.

    MEDICAL APPARATUS PACKAGE
    7.
    发明公开
    MEDICAL APPARATUS PACKAGE 审中-公开
    医疗设备包

    公开(公告)号:EP3229861A1

    公开(公告)日:2017-10-18

    申请号:EP15808210.7

    申请日:2015-12-11

    申请人: SANOFI

    IPC分类号: A61M5/00

    CPC分类号: A61M5/001 A61M5/002

    摘要: A package (10) for components of a medical apparatus comprising a plurality of panels (12-20) defining a container (11) having an interior space. A first component of the medical apparatus is disposed within the interior space. The first component of the medical apparatus comprises a medicament delivery device. The container (11) comprises a base panel (12) which forms a bottom wall of the container (11). At least one lid panel (16) is connected to the base panel (12) and is foldable into a position in which it extends coplanar with the base panel (12) when the container (11) is manipulated into an open configuration. At least one lid panel (16) includes a sterile surface forming a preparation surface upon which a user may place components of a medical apparatus when the container (11) is in the open configuration. Also disclosed is a medical apparatus comprising such a package with a container of medicament (26) within the interior space of the container (11).

    摘要翻译: 一种用于医疗设备的部件的包装(10),包括限定具有内部空间的容器(11)的多个面板(12-20)。 医疗器械的第一部件设置在内部空间内。 医疗设备的第一部件包括药物输送装置。 容器(11)包括形成容器(11)的底壁的基板(12)。 至少一个盖板(16)连接到基板(12),并且当容器(11)被操作成打开构型时可折叠到与基板(12)共面的位置。 至少一个盖板(16)包括形成准备表面的无菌表面,当容器(11)处于打开构型时,使用者可以在其上放置医疗器械的部件。 还公开了一种医疗装置,其包括具有在容器(11)的内部空间内的药物容器(26)的这种包装。

    PEN-TYPE DRUG INJECTION DEVICE HAVING MULTIPLE-USE NEEDLE MODULE WITH NEEDLE CLEANING RESERVOIR
    8.
    发明公开
    PEN-TYPE DRUG INJECTION DEVICE HAVING MULTIPLE-USE NEEDLE MODULE WITH NEEDLE CLEANING RESERVOIR 审中-公开
    STI GE IR IR UNG UNG UNG UNG UNG UNG UNG UNG IR IR IR IR IR IR IR IR IR IR IR IR IR IR IR IR IR IR

    公开(公告)号:EP3142725A1

    公开(公告)日:2017-03-22

    申请号:EP15721245.7

    申请日:2015-05-08

    申请人: Novo Nordisk A/S

    IPC分类号: A61M5/00 A61M5/32

    摘要: Disclosed is a medical injection device (1) comprising a needle assembly (20) having a cannula (21) and a telescopic shield (30) for covering the distal tip (23) in a no use situation. The telescopic shield further carries a cleaning reservoir (40) for cleaning the needle cannula between two subsequent injections. The cleaning reservoir is provided with an opening (43) connecting to an overflow reservoir (51/55) such that the cleaning liquid contained in the cleaning reservoir can retract and expand upon temperature changes and does not enter the needle lumen instead. In one example, the overflow reservoir is formed as a channel (51).

    摘要翻译: 公开了一种医疗注射装置(1),其包括具有插管(21)的针组件(20)和用于在不使用情况下覆盖远侧末端(23)的伸缩屏蔽(30)。 伸缩式护罩还具有用于在两次后续注射之间清洁针管的清洁容器(40)。 清洁储存器设置有连接到溢流储存器(51/55)的开口(43),使得容纳在清洁储存器中的清洁液体可以在温度变化时缩回和膨胀,而不会进入针管腔。 在一个示例中,溢流容器形成为通道(51)。

    MEDICAL DEVICE PACKAGING BODY
    10.
    发明授权
    MEDICAL DEVICE PACKAGING BODY 有权
    包装体医疗器械

    公开(公告)号:EP2818190B1

    公开(公告)日:2016-11-02

    申请号:EP13751707.4

    申请日:2013-02-14

    IPC分类号: A61M5/00

    摘要: The present invention provides a medical device package in which a sealing member does not adhere to a protection sheet or a syringe in a container main body even if sterilization processing is applied in the container main body using vapor or a gas. A syringe storage container of the medical device package (syringe package) includes the container main body and the sheet-like sealing member. The container main body includes a peripheral wall portion, a bottom, an opening, and a syringe holding member. The sealing member is glued to the container main body, and seals the opening. A surface of the sealing member, which faces the container main body, includes an adhesive applied area and an adhesive non-applied area. The adhesive non-applied area is an area facing at least a filling opening of the syringe held in the syringe holding member.