CN105358194B - 注射装置 - Google Patents

注射装置 Download PDF

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CN105358194B
CN105358194B CN201480033329.6A CN201480033329A CN105358194B CN 105358194 B CN105358194 B CN 105358194B CN 201480033329 A CN201480033329 A CN 201480033329A CN 105358194 B CN105358194 B CN 105358194B
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injection device
locking mechanism
actuator
substance
indicator
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CN105358194A (zh
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D·I·詹宁斯
A·比塔尔
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Cilag GmbH International
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31501Means for blocking or restricting the movement of the rod or piston
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2033Spring-loaded one-shot injectors with or without automatic needle insertion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31576Constructional features or modes of drive mechanisms for piston rods
    • A61M5/31583Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod
    • A61M5/31586Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod performed by rotationally moving or pivoted actuator, e.g. an injection lever or handle
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; 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
    • A61M5/3202Devices for protection of the needle before use, e.g. caps
    • A61M5/3204Needle cap remover, i.e. devices to dislodge protection cover from needle or needle hub, e.g. deshielding devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2006Having specific accessories
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/206With automatic needle insertion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2073Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically preventing premature release, e.g. by making use of a safety lock
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2073Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically preventing premature release, e.g. by making use of a safety lock
    • A61M2005/208Release is possible only when device is pushed against the skin, e.g. using a trigger which is blocked or inactive when the device is not pushed against the skin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/24Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M2005/2403Ampoule inserted into the ampoule holder
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M2005/3125Details specific display means, e.g. to indicate dose setting
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; 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
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3245Constructional features thereof, e.g. to improve manipulation or functioning
    • A61M2005/3247Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; 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
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/326Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
    • A61M2005/3267Biased sleeves where the needle is uncovered by insertion of the needle into a patient's body

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Electrical Control Of Air Or Fuel Supplied To Internal-Combustion Engine (AREA)
  • Fuel-Injection Apparatus (AREA)
  • Injection Moulding Of Plastics Or The Like (AREA)
  • Chemical Or Physical Treatment Of Fibers (AREA)
  • Polarising Elements (AREA)

Abstract

本发明公开了一种注射装置(110),所述注射装置包括:致动器(710),该致动器适于在被致动时使注射序列开始;锁定机构,该锁定机构适于在锁定位置和解锁位置之间运动,在锁定位置,锁定机构防止致动器被致动,在解锁位置,致动器可被致动以使注射序列开始。指示器(570)被构造成能够提供锁定机构是处于其锁定位置还是处于其解锁位置的视觉指示。

Description

注射装置
技术领域
本发明涉及用于递送注射剂的注射装置,以及注射套件和操作该注射装置的方法。
背景技术
自动注射器可从WO 95/35126和EP-A-0 516 473得知并且往往采用驱动弹簧和某一形式的释放机构,一旦假定注射器的内容已排出,所述释放机构便释放注射器使其不受该驱动弹簧的影响,以允许其通过复位弹簧缩回。
自动注射器可从WO 2007/036676得知,该自动注射器具有在可启动释放机构之前必须脱离的锁定机构。例如当移除夹紧覆盖注射器针头的罩的帽盖时,该锁定机构还在其锁定位置防止注射器克服复位弹簧的偏置而向前运动离开注射装置。在WO 2007/036676中所述的注射装置中,该锁定机构包括从该注射装置的开口端突起的套筒。该套筒通过有有回弹力的弹簧机构偏置到其延伸位置,必须克服此偏置以使该锁定机构脱离。该锁定机构可通过例如使该滑动套筒向内运动到该注射装置中(即,使该套筒缩回)而脱离。这可通过将该滑动套筒的端部压到组织上然后启动该释放机构来完成。
已发现,注射装置诸如WO2007/036676中所述的那些注射装置的用户难以分辩滑动套筒何时已充分缩回以便允许启动所述装置。这对用户来说可能极其令人沮丧,因为他们在启动注射时由于不知道该滑动套筒尚未完全缩回而可能作出无数不成功的尝试。此外,沮丧的用户可能尝试强力推动该注射装置(即,通过向触发器施加过度压力),并且因此损坏该注射机构。
因此,需要提供如下注射装置:其告知用户关于该注射装置从锁定状态到可执行注射的状态的进度。本发明解决此问题。
发明内容
本发明的第一方面提供一种注射装置,该注射装置包括:致动器,该致动器适于在被致动时使注射序列开始;锁定机构,该锁定机构适于在锁定位置和解锁位置之间运动,在锁定位置,该锁定机构防止该致动器被致动,在解锁位置,该致动器可被致动以使该注射序列开始;和指示器,该指示器被构造成能够提供该锁定机构是处于其锁定位置还是处于其解锁位置的视觉指示。
该指示器允许用户目视检查该锁定机构的状态,从而分辩该致动器是否可致动。因此,用户不再需要认为或假定在尝试运动该锁定机构之后该锁定机构处于其解锁状态,而是可获得该事实的视觉确认,或者了解需要更多努力才能致动该致动器。已发现这令用户舒适,特别是那些可能操作具有此类安全特征结构的注射装置有困难的不灵活的用户。
该指示器可包括位于指示器上的指示器部件,当锁定机构在其锁定位置和解锁位置之间运动时,该指示器部件随锁定机构一起运动。在简单制造的具体实施中,该指示器可形成与该锁定机构相同的部件的一部分。因此,不需要额外部件。此外,该指示器正确发挥作用(即,其中关于该锁定机构是否处于解锁状态的指示正确)的概率最大化,因为其不受制于外部公差,而是与该锁定机构的进度直接相关。另选地,该注射装置可包括独立滑动部件,该滑动部件形成指示器,并且锁定机构直接或经由一个或多个额外部件作用于该滑动部件。这是有利的,因为该独立滑动部件可专门设计成最大化该部件的可视性,并且因此不受制于锁定机构的设计约束。
该注射装置还可包括外壳,该致动器和锁定机构可运动地安装至外壳。该外壳可包括指示器孔以便于目视检查该指示器。这允许将指示器的部件容纳在注射装置内部,从而保护部件免受损害或损坏。
优选地,当锁定机构处于其锁定位置时,指示器部件的至少一部分或全部可通过该指示器孔看见。一方面,该孔可能极大,使得锁定机构的大部分可见,并且该指示器可以是锁定机构上的简单标记,其进度可由用户通过该孔监测。在这种情况下,用户可看到,该注射装置能够例如在该标记与该外壳上的另一标记对准时被致动。另一方面,该孔可能相对较小,并且该指示器可能仅是该锁定机构自身的特定部分,例如颜色明显不同于该机构的其余部分的特定部分。在这种情况下,用户可看到,该注射装置能够在该孔完全充满该不同颜色时被致动。
当然,应当了解,有颜色的部分仅是本发明中提供视觉指示器的一种方式。该指示可提供由以下提供:与不同状态对应的的具有不同颜色的一个或多个区段;颜色梯度(例如红色过渡到绿色);该指示器上对应于不同状态的一个或多个符号、字符或图像、或技术人员将想到的任何其他方式。
指示器和指示器孔之间的关系可以各种方式实现,如下文所述。
当该锁定机构处于其锁定位置时,该指示器孔可被指示器部件的至少一部分完全覆盖。当该锁定机构不处于其锁定位置时,该指示器孔的至少一部分可不被指示器部件覆盖。
此外,当该锁定机构处于其解锁位置时,指示器部件的至少一部分或全部可通过该指示器孔看见。
另选地,当该锁定机构处于其解锁位置时,该指示器孔可被指示器部件的至少一部分完全覆盖。当该锁定机构不处于其解锁位置时,该指示器孔的至少一部分可不被指示器部件覆盖。
该锁定机构可包括接触部分,该接触部分适于在该锁定机构处于其锁定位置时接触致动器的接合表面。因此,提供阻挡致动器的物理屏障,这防止该致动器在锁定机构处于其锁定位置时被意外致动。该接触部分可适于在该锁定机构处于其解锁位置时不接触该致动器的接合表面。例如,当该锁定机构处于其解锁位置时,该物理屏障可被完全移除而不会干扰该致动器。
在特别优选的实施例中,该锁定机构可在其锁定位置和其解锁位置之间运动,使得该接触部分从其接触该致动器的接合表面的位置运动到其不再接触该致动器的接合表面的位置。
该致动器可被构造成能够在防止该注射序列开始的第一位置和发生该注射序列开始的第二位置之间运动。该致动器可围绕枢轴在其第一位置和第二位置之间旋转。
在本发明的某些实施例中,该注射装置还包括驱动机构。在此类实施例中,该致动器可包括锁定表面,当致动器处于其第一位置时,该锁定表面抑制驱动机构;并且当该驱动机构处于其第二位置时,该锁定表面不抑制驱动机构。
优选地,该注射装置还包括注射器,该注射器可在注射序列开始时由驱动机构从注射器完全容纳在注射装置主体内的位置运动到注射器的针头经由注射开口从注射装置的外壳延伸的位置,其中驱动机构适于在注射器处于其延伸位置时经由针头排出注射器的内容物。自然地,注射器仅是优选的,并且还可提供用于容纳并排出药剂的其他构件,例如带有或不带整体针头或套管的药水瓶或安瓿。
优选地,锁定机构包括滑动部件,该滑动部件滑动以使锁定机构在其锁定位置和解锁位置之间运动。该滑动部件可被构造成能够向内滑动到注射装置中以将其从其锁定位置运动到其解锁位置。
当滑动部件处于其解锁位置时,滑动部件可从外壳中的滑动部件开口(通常但不一定为注射开口)突出。因此,该滑动部件可接合用户的皮肤,并且在用户朝向皮肤推动注射装置时向内运动到注射装置的外壳中。在优选实施例中,滑动部件为滑动套筒。
在任一实施例中,注射装置可包含选自由以下项组成的组的物质:戈利木单抗、激素、抗毒素、用于控制疼痛的物质、用于控制血栓的物质、用于控制或消除感染的物质、肽、蛋白质、人胰岛素或人胰岛素类似物或衍生物、多糖、DNA、RNA、酶、抗体、寡核苷酸、抗过敏药、抗组胺药、抗炎药、皮质类固醇、改善病情抗风湿药、促红细胞生成素、或疫苗,以用于治疗或预防类风湿性关节炎、牛皮癣关节炎、强直性脊柱炎、溃疡性结肠炎、激素缺乏症、中毒、疼痛、血栓、感染、糖尿病、糖尿病性视网膜病、急性冠脉综合征、心绞痛、心肌梗死、动脉粥样硬化、恶性肿瘤、黄斑变性、过敏症、花粉病、炎症、贫血或脊髓发育不良、或用于表达保护性免疫。
所谓“注射装置可容纳物质”是指,该物质可被容纳在注射装置内的合适的药剂容器(例如药水瓶或注射器)内。此药剂容器可容纳其他物质,诸如另外的活性成分或非活性成分。
在本发明的另一方面,通过使用根据上述任一实施例所述的注射装置将物质递送至人类受治疗者来提供所述物质以用于治疗或预防类风湿性关节炎、牛皮癣关节炎、强直性脊柱炎、溃疡性结肠炎、激素缺乏症、中毒、疼痛、血栓、感染、糖尿病、糖尿病性视网膜病、急性冠脉综合征、心绞痛、心肌梗死、动脉粥样硬化、恶性肿瘤、黄斑变性、过敏症、花粉病、炎症、贫血或脊髓发育不良、或用于表达保护性免疫,所述物质选自戈利木单抗、激素、抗毒素、用于控制疼痛的物质、用于控制血栓的物质、用于控制或消除感染的物质、肽、蛋白质、人胰岛素或人胰岛素类似物或衍生物、多糖、DNA、RNA、酶、抗体、寡核苷酸、抗过敏药、抗组胺药、抗炎药、皮质类固醇、改善病情抗风湿药、促红细胞生成素、或疫苗。
在本发明的另一方面,提供一种注射装置,通过使用该注射装置将选自戈利木单抗、激素、抗毒素、用于控制疼痛的物质、用于控制血栓的物质、用于控制或消除感染的物质、肽、蛋白质、人胰岛素或人胰岛素类似物或衍生物、多糖、DNA、RNA、酶、抗体、寡核苷酸、抗过敏药、抗组胺药、抗炎药、皮质类固醇、改善病情抗风湿药、促红细胞生成素、或疫苗的物质递送至人类受治疗者以用于治疗或预防类风湿性关节炎、牛皮癣关节炎、强直性脊柱炎、溃疡性结肠炎、激素缺乏症、中毒、疼痛、血栓、感染、糖尿病、糖尿病性视网膜病、急性冠脉综合征、心绞痛、心肌梗死、动脉粥样硬化、恶性肿瘤、黄斑变性、过敏症、花粉病、炎症、贫血或脊髓发育不良、或用于表达保护性免疫,其中所述注射装置是上述任一实施例所述的注射装置。
所谓“递送物质”是指,该注射装置用于将所述物质注射到人类受治疗者体内,例如通过皮下注射、皮内注射或肌肉注射。可结合其他物质诸如另外的活性成分或非活性成分来施用所述物质。
附图说明
现在结合附图以举例方式描述本发明,其中:
图1示出示例性注射装置,其显示外壳内的机构;
图2示出本发明的注射装置的平面图;
图3示出本发明的注射装置的释放机构的细节;
图4示出本发明注射装置的释放机构的部分的详细视图;
图5示出本发明的注射装置的第一实施例;
图6示出本发明的注射装置的第二实施例;
图7示出本发明的注射装置的第三实施例;
图8a和图8b更详细地示出处于锁定位置和解锁位置的图7中的实施例的指示器;
图9更详细地示出图7的实施例的内部机构;
图10更详细地示出图5的实施例的内部机构;
图11示出示例性注射装置的框架元件;
图12示出图10的实施例的框架元件;并且
图13至图15示出图10中所示内部机构的替代实施例。
具体实施方式
在图1和图2中示出示例性注射装置110。注射装置110具有注射装置外壳112和纵向轴线101。图1和图2仅示出外壳112的下半部分。外壳112的上半部分不存在,以便可清楚地看见内部机构。
注射器(未示出)容纳在外壳112中。注射装置110包括触发器114作为启动装置的一部分。触发器114可围绕枢轴115从静止位置(如图2中所示)旋转到活动位置。触发器114的近侧端部114b与驱动联接装置121连接,驱动弹簧120作用于驱动联接装置121。驱动联接装置121与该注射器连通。驱动联接装置和驱动弹簧全部形成该启动装置的一部分,其通过作用于该注射器而允许递送注射剂。
注射装置110包括释放机构126,该释放机构呈圆柱形套筒形式,该圆柱形套筒从注射装置110的远侧端部突起。
为实现注射剂的递送,触发器114沿方向R围绕枢轴115旋转(即,在其第一端部114a处向下进入外壳112中)。此导致触发器114的第二端部114b从驱动联接装置121脱离,从而允许驱动弹簧120沿纵向轴线101驱动注射器122(经由驱动联接装置121)并且离开外壳112中的孔118。
然而,当释放机构126处于其阻碍位置时(此对应于该释放机构从外壳112的远侧端部突起),呈突起154(如图3中示出)形式的阻碍物定位成邻接触发器114的部分150的下表面。以此方式,突起154阻碍该触发器的旋转,从而阻碍注射剂的递送。为进行注射,释放机构运动到第二位置,此对应于释放机构126沿纵向轴线101的方向运动到外壳112中。当释放机构处于其第二位置时,突起154与触发器114中的切口152对准。突起154可接收在切口152中,并且因此触发器可围绕枢轴115旋转,并且可实现注射剂的递送。
释放机构包括从滑动套筒126朝近侧延伸的框架116。突起154从框架116的近侧部分径向向外延伸。该框架被构造成能够将滑动套筒部分126(其在该装置的最远侧端部处接合用户的皮肤)联接到该突起。其借助两个朝近侧延伸的腿这样做,从而使用尽可能少的多余材料以防止浪费并避免干扰该注射装置的其他部件。因此,该框架很大程度上是打开的。
现转向图5,显示根据本发明的注射装置500的第一实施例。与上述示例性注射装置一样,注射装置500包括具有壳鼻504的外壳502和滑动套筒506,滑动套筒506被构造成能够接合用户的皮肤从而在装置的外壳502内朝近侧推动。如上所述,该滑动套筒可从滑动套筒防止致动器(例如触发器)启动的锁定位置运动到滑动套筒不防止致动器(例如触发器)启动的解锁位置。
外壳的壳鼻包括孔508,用户可通过孔508观察以目视检查该锁定机构—在此情况下为滑动套筒506部分。该孔可以是孔穴,或者可以是透明材料或半透明材料。滑动套筒通过孔508可见。因此,该滑动套筒充当该用户的关于滑动套筒状态的指示器。例如,当该滑动套筒处于锁定位置时,该指示器将显示一种情形,并且当该滑动套筒处于解锁位置时,该指示器将显示另一种情形。下文更详细地对此进行描述。
图6中示出了根据本发明的注射装置600的第二实施例。相似参考编号示出关于图5的对应特征。同样,外壳604包括孔608。通过孔608,用户可观察以目视检查该锁定机构。然而,就此实施例而言,该孔不位于壳鼻604中,而是在外壳602的主体中。孔608相对于致动器(即触发器)径向偏移,以便能容易地了解何时以优选方式保持该注射装置。
图7中示出了根据本发明的注射装置700的第三实施例。相似参考编号示出关于图5和图6的对应特征。同样,外壳704包括孔708,通过孔708,用户可观察以目视检查该锁定机构。然而,就此实施例而言,该孔位于外壳702的主体中,但与致动器(即触发器)710径向对准。将孔708定位在该外壳的此部分处使得容易了解何时以替代方式保持该注射装置,并且还允许方便地对部件进行内部布置,如下文更详细地描述。
图8a、图8b、图9和图10示出了在使用中的本发明的第三实施例。具体地,图8a示出当该锁定机构处于锁定位置时通过孔708的视觉指示器。图8b示出当该锁定机构处于解锁位置时通过孔708的视觉指示器。如图可见,该视觉指示器的外观已改变,指示该锁定机构处于解锁位置。
图9更详细地示出图7的实施例的内部机构。从图中可以看出,锁定机构提供突起754从其延伸的框架716。如上文结合图1至图4所述,该突起在锁定位置中接合致动器(即,触发器714),从而防止该致动器被致动。更详细地,致动器714包括延伸部分760,其从触发器714的远侧端部朝远侧延伸。该延伸部分包括切口762和接片764。在锁定位置中,延伸部分760接合接片764。在解锁位置中,延伸部分760接合切口762。
还可以看出,与该致动器径向对准的孔708位于延伸部分760的区域中,并且位于切口762正上方。因此,当锁定机构处于锁定位置时,锁定机构(具体地,延伸部分)由于接合接片而不可见。然而,当锁定机构处于解锁位置并且接合切口时,锁定机构(具体地,延伸部分)通过孔可见。因此,锁定机构自身的一部分充当该锁定机构状态的视觉指示器。使锁定机构(具体地,延伸部分)具有不同的颜色,从而该视觉指示器甚至更有效。
图10更详细地示出图5的实施例的内部机构。除了添加额外指示器接片570以外,锁定机构和致动器与图9中所示的锁定机构和致动器相同,下文更详细地论述。
孔508位于外壳的壳鼻部分中;即,不在延伸部分560的区域中。因此,指示器接片570设置在壳鼻区域中的锁定机构上。当锁定机构处于锁定位置时,锁定机构(具体地,指示器接片570)因其不与孔508成直线而不可见。然而,当锁定机构处于解锁位置时,锁定机构(具体地,指示器接片570)运动成与孔508成直线并因而通过该孔可见。因此,同样地,锁定机构自身的一部分充当该锁定机构状态的视觉指示器。同样,使锁定机构(具体地,延伸部分)具有不同的颜色,从而该视觉指示器甚至更有效。
图11示出用于示例性注射装置的框架元件1116。图12示出用于图10的注射装置的框架元件1216。如图可见,框架元件1216包括其远侧端部处的指示器接片516。指示器接片516包括其中有切口的环形材料带。
图13和图14示出可与注射装置的壳鼻部分中的孔一起使用的替代框架元件1316。图15a和图15b示出在使用中的替代性框架元件,其中该框架元件可运动成与壳鼻中的孔对准和不对准。
技术人员将了解,以上实施例也可以其他方式实施;即,该锁定机构可被构造成能够当其处于锁定位置时与孔成直线并且当处于解锁位置时运动成不与孔成直线。根据孔的特定位置和框架元件、延伸部分或指示器接片的特定构造,该装置可向用户指示,当指示器孔被指示器部件的至少一部分完全覆盖时,该锁定机构处于锁定位置;当指示器孔的至少一部分不被指示器部件覆盖时,该锁定机构不处于其锁定位置。另选地,该装置可向用户指示:当指示器孔被指示器部件的至少一部分完全覆盖时,该锁定机构处于解锁位置;当指示器孔的至少一部分不被指示器部件覆盖时,该锁定机构不处于其解锁位置。
此外,技术人员将了解,该锁定机构可提供为单个整体模制的部件,或提供为独立部件。例如,这些框架元件可与滑动套筒分离或机械联接到滑动套筒,或者可提供为单个整体部件。
在使用中,如上所述的此类注射装置可用于递送如下物质,诸如:戈利木单抗、激素、抗毒素、用于控制疼痛的物质、用于控制血栓的物质、用于控制或消除感染的物质、肽、蛋白质、人胰岛素或人胰岛素类似物或衍生物、多糖、DNA、RNA、酶、抗体、寡核苷酸、抗过敏药、抗组胺药、抗炎药、皮质类固醇、改善病情抗风湿药、促红细胞生成素、或疫苗,以用于治疗或预防类风湿性关节炎、牛皮癣关节炎、强直性脊柱炎、溃疡性结肠炎、激素缺乏症、中毒、疼痛、血栓、感染、糖尿病、糖尿病性视网膜病、急性冠脉综合征、心绞痛、心肌梗死、动脉粥样硬化、恶性肿瘤、黄斑变性、过敏症、花粉病、炎症、贫血或脊髓发育不良、或用于表达保护性免疫。除这些物质以外,该注射装置内容纳的任何药剂还可包含其他物质,例如非活性成分,如技术人员将了解的。
当然,技术人员应当理解,特定物质有效用于治疗或预防如本领域中熟知的特定症状。例如,已知抗过敏药有效用于治疗或预防过敏;抗组胺药有效用于治疗或预防花粉病;抗炎药有效用于治疗或预防炎症等等。因此,设想任意选择本文中或权利要求中所列出的一种或多种物质,以用于治疗或预防已知那些物质针对其有效的一种或多种症状。
然而,在特定实例中,戈利木单抗已知有效用于治疗或预防类风湿性关节炎、牛皮癣关节炎、强直性脊柱炎或溃疡性结肠炎中的一者或多者,或者类风湿性关节炎、牛皮癣关节炎、强直性脊柱炎和溃疡性结肠炎的任意组合,或者类风湿性关节炎、牛皮癣关节炎、强直性脊柱炎和溃疡性结肠炎的全部。
戈利木单抗可任选地结合一种或多种非活性成分诸如L-组氨酸、L-组氨酸盐酸盐水合物、山梨醇、聚山梨酸酯80和水中的任一者或全部来使用。戈利木单抗可存在于其中戈利木单抗是唯一活性成分的组合物中。例如,戈利木单抗可以给药。
当然,应当理解,上文已仅以举例方式描述了本发明,并且可在本发明的范围内作出对细节的修改。

Claims (18)

1.一种注射装置,包括:
致动器,所述致动器适于在被致动时使注射序列开始;
锁定机构,所述锁定机构适于在锁定位置和解锁位置之间运动,在所述锁定位置,所述锁定机构防止所述致动器被致动,在所述解锁位置,所述致动器能够被致动以使所述注射序列开始,其中所述锁定机构包括滑动部件,所述滑动部件滑动以使所述锁定机构在其锁定位置和解锁位置之间运动,其中所述滑动部件被构造成能够向内滑动到所述注射装置中以使所述滑动部件从其锁定位置运动到其解锁位置;
外壳,所述致动器和所述锁定机构可运动地安装至所述外壳;
指示器,所述指示器被构造成能够提供所述锁定机构是处于其锁定位置还是处于其解锁位置的视觉指示,其中所述指示器包括位于所述指示器上的指示器部件,当所述锁定机构在其锁定位置和解锁位置之间运动时,所述指示器部件随所述锁定机构一起运动,
其中所述外壳包括指示器孔以便于所述指示器的视觉检查。
2.根据权利要求1所述的注射装置,其中当所述锁定机构处于其锁定位置时,所述指示器部件的至少一部分或全部能够通过所述指示器孔看见。
3.根据权利要求2所述的注射装置,其中当所述锁定机构处于其锁定位置时,所述指示器孔被所述指示器部件的至少一部分完全覆盖,并且当所述锁定机构不处于其锁定位置时,所述指示器孔的至少一部分不被所述指示器部件覆盖。
4.根据权利要求1所述的注射装置,其中当所述锁定机构处于其解锁位置时,所述指示器部件的至少一部分或全部能够通过所述指示器孔看见。
5.根据权利要求2所述的注射装置,其中当所述锁定机构处于其解锁位置时,所述指示器孔被所述指示器部件的至少一部分完全覆盖,并且当所述锁定机构不处于其解锁位置时,所述指示器孔的至少一部分不被所述指示器部件覆盖。
6.根据权利要求1-5中任一项所述的注射装置,其中所述锁定机构包括接触部分,所述接触部分适于在所述锁定机构处于其锁定位置时接触所述致动器的接合表面。
7.根据权利要求6所述的注射装置,其中所述接触部分适于在所述锁定机构处于其解锁位置时不接触所述致动器的接合表面。
8.根据权利要求7所述的注射装置,其中所述锁定机构能够在其锁定位置和其解锁位置之间运动,使得所述接触部分从其接触所述致动器的所述接合表面的位置运动到其不再接触所述致动器的所述接合表面的位置。
9.根据权利要求1所述注射装置,其中所述致动器在防止所述注射序列开始的第一位置和发生所述注射序列开始的第二位置之间运动。
10.根据权利要求9所述的注射装置,还包括驱动机构,其中所述致动器包括锁定表面,当所述致动器处于其第一位置时,所述锁定表面抑制所述驱动机构,并且当所述驱动机构处于其第二位置时,所述锁定表面不抑制所述驱动机构。
11.根据权利要求10所述的注射装置,还包括注射器,所述注射器能够在所述注射序列开始时由所述驱动机构从所述注射器被完全容纳在所述注射装置主体内的位置运动到所述注射器的针头经由注射开口从所述注射装置的外壳延伸的位置,其中所述驱动机构适于在所述注射器处于其延伸位置时经由所述针头排出所述注射器的内容物。
12.根据权利要求11所述的注射装置,其中当滑动部件处于其解锁位置时,所述滑动部件从所述外壳中的滑动部件开口突出。
13.根据权利要求12所述的注射装置,其中所述滑动部件开口是所述注射开口。
14.根据权利要求12或13所述的注射装置,其中所述滑动部件是滑动套筒。
15.根据权利要求1-5中任一项所述的注射装置,其中所述致动器围绕枢轴在其第一位置和第二位置之间旋转。
16.一种根据权利要求1-5中任一项所述的注射装置,
所述注射装置包含选自由以下项组成的组的物质:戈利木单抗、激素、抗毒素、用于控制疼痛的物质、用于控制血栓的物质、用于控制或消除感染的物质、肽、蛋白质、人胰岛素或人胰岛素类似物或衍生物、多糖、DNA、RNA、酶、抗体、寡核苷酸、抗过敏药、抗组胺药、抗炎药、皮质类固醇、改善病情抗风湿药、促红细胞生成素、或疫苗,
以用于治疗或预防类风湿性关节炎、牛皮癣关节炎、强直性脊柱炎、溃疡性结肠炎、激素缺乏症、中毒、疼痛、血栓、感染、糖尿病、糖尿病性视网膜病、急性冠脉综合征、心绞痛、心肌梗死、动脉粥样硬化、恶性肿瘤、黄斑变性、过敏症、花粉病、炎症、贫血或脊髓发育不良、或用于表达保护性免疫。
17.一种选自由以下项组成的组的物质:戈利木单抗、激素、抗毒素、用于控制疼痛的物质、用于控制血栓的物质、用于控制或消除感染的物质、肽、蛋白质、人胰岛素或人胰岛素类似物或衍生物、多糖、DNA、RNA、酶、抗体、寡核苷酸、抗过敏药、抗组胺药、抗炎药、皮质类固醇、改善病情抗风湿药、促红细胞生成素、或疫苗,
所述物质通过使用根据权利要求1至15中任一项所述的注射装置将所述物质递送至人类受治疗者,
以用于治疗或预防类风湿性关节炎、牛皮癣关节炎、强直性脊柱炎、溃疡性结肠炎、激素缺乏症、中毒、疼痛、血栓、感染、糖尿病、糖尿病性视网膜病、急性冠脉综合征、心绞痛、心肌梗死、动脉粥样硬化、恶性肿瘤、黄斑变性、过敏症、花粉病、炎症、贫血或脊髓发育不良、或用于表达保护性免疫。
18.一种注射装置,所述注射装置用于通过使用所述注射装置将物质递送至人类受治疗者来治疗或预防类风湿性关节炎、牛皮癣关节炎、强直性脊柱炎、溃疡性结肠炎、激素缺乏症、中毒、疼痛、血栓、感染、糖尿病、糖尿病性视网膜病、急性冠脉综合征、心绞痛、心肌梗死、动脉粥样硬化、恶性肿瘤、黄斑变性、过敏症、花粉病、炎症、贫血或脊髓发育不良、或用于表达保护性免疫,
所述物质选自由以下项组成的组:戈利木单抗、激素、抗毒素、用于控制疼痛的物质、用于控制血栓的物质、用于控制或消除感染的物质、肽、蛋白质、人胰岛素或人胰岛素类似物或衍生物、多糖、DNA、RNA、酶、抗体、寡核苷酸、抗过敏药、抗组胺药、抗炎药、皮质类固醇、改善病情抗风湿药、促红细胞生成素、或疫苗,
其中所述注射装置是根据权利要求1至15中任一项所述的注射装置。
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