CN105358192B - 用于注射装置的引导件 - Google Patents

用于注射装置的引导件 Download PDF

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CN105358192B
CN105358192B CN201480033292.7A CN201480033292A CN105358192B CN 105358192 B CN105358192 B CN 105358192B CN 201480033292 A CN201480033292 A CN 201480033292A CN 105358192 B CN105358192 B CN 105358192B
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guiding piece
shell
injection device
skin
external member
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CN105358192A (zh
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A·比塔尔
D·I·詹宁斯
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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
    • A61M5/32Needles; 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
    • A61M5/3287Accessories for bringing the needle into the body; 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
    • 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
    • A61M5/32Needles; 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
    • 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
    • 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
    • A61M5/42Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for desensitising skin, for protruding skin to facilitate piercing, or for locating point where body is to be pierced
    • A61M5/425Protruding skin to facilitate piercing, e.g. vacuum cylinders, vein immobilising means

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  • Health & Medical Sciences (AREA)
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  • Engineering & Computer Science (AREA)
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Abstract

本发明提供了一种用于使注射装置(110)与使用者接触的引导件(200);所述引导件(200)具有适于接合所述注射装置(110)的外壳(112)的第一端(210)和适于接合使用者的皮肤的表面的第二端(220),其中所述引导件(200)允许所述外壳(112)朝所述使用者的皮肤运动。

Description

用于注射装置的引导件
技术领域
本发明涉及用于通常称为自动注射器的注射装置的外壳的引导件和包括该注射装置的套件,该注射装置接收注射器,使注射器延伸并排出其内容物。
背景技术
自动注射器从WO 95/35126和EP-A-0 516 473已知并且往往采用驱动弹簧和某种形式的释放机构,该释放机构在认为注射器的内容物已被排出后从驱动弹簧的影响中释放注射器,以允许通过返回弹簧使注射器回缩。
从WO 2007/036676已知一种自动注射器,该自动注射器具有锁定机构,在释放机构可被启用之前,该锁定机构必须被脱开。在其锁定位置,锁定机构也防止注射器抵抗返回弹簧的偏压而向前运动到注射装置之外,例如在夹持覆盖注射器针的罩的顶盖被移除时。在WO 2007/036676中描述的注射装置中,锁定机构包括从注射装置的开口端突出的套管。套管被弹性弹簧机构偏压至其伸出位置,该弹簧机构必须被克服以脱开锁定机构。锁定机构可通过例如将滑动套管向内运动到注射装置中而脱开。通过将滑动套管的端部抵靠组织施力,然后启用释放机构,可以做到这一点。
对于使用者来说,将滑动套管抵靠组织定位在正确的角度并且在锁定机构脱开时将滑动套管保持在该位置可能是困难的。确保滑动套管以正确的角度用力抵靠组织并且在锁定机构被克服时在组织上保持足够稳定是重要的,以确保所述装置在被启用时的可靠操作。
发明内容
本发明的注射装置和套件设计成解决上述问题。
在本发明的第一方面,提供了一种用于使注射装置与使用者接触的引导件,该引导件具有适于接合注射装置的外壳的第一端和适于接合使用者的皮肤的表面的第二端,其中引导件允许外壳朝使用者的皮肤运动。
引导件确保外壳以正确的角度朝使用者的皮肤运动,因为它与皮肤接合并将注射装置的外壳朝皮肤导向。引导件的尺寸可被设计用于与现有的注射装置一起使用,从而没必要修改注射装置。引导件也可用来在长(高粘度)注射或肌内注射期间将自动注射器保持在位。
引导件的第一端可以是开放的。所谓“开放”是指注射装置的至少一部分可以穿过第一端。
这允许将引导件放置在皮肤上,并且允许注射装置的排放喷嘴穿过引导件朝向使用者的皮肤。
引导件的第二端可以是开放的,从而为使用者提供将注射装置插入引导件的直接方式。同样,所谓“开放”是指注射装置的至少一部分可以穿过第二端。
引导件可以是圆柱形的。通常,注射装置是圆柱形的,因此,引导件的这种形状很好地适形于大多数注射装置。据发现,圆柱形引导件也容易抓握,并且当被放置在使用者的皮肤上时是最舒适的,因为它没有锐角。此外,该形状为注射装置向下行进提供了线性路径,并且牢固地保持注射装置的外壳。当然,其他形状也是可能的。
引导件可以是朝第二端扩张的。扩张的端部使引导件稳定在皮肤上,从而使得当外壳朝皮肤运动时引导件的位置不变。
引导件可以被制成框架(而不是例如实心的管结构)。在这种情况下,使用者可以看到注射装置朝皮肤传递,这被发现是特别让人放心的,因为使用者能预料到注射装置何时会接触皮肤。
另选地,引导件可以形成有连续的外表面。这提供了更可靠的引导件,因为在注射装置朝皮肤推进时,使用者不能触及注射装置的远端。
引导件可包括在其第二端处的至少一个稳定元件,所述至少一个稳定元件适于从引导件突出并将引导件稳定在皮肤上。这有助于提高引导件在使用期间在皮肤上的稳定性。在一个优选的实施例中,引导件可包括在其第二端处的三个稳定元件。额外的稳定元件为皮肤上的引导件提供额外的稳定性。
引导件可包括第一部件和可相对于第一部件运动的第二部件。第二部件可用来接合外壳,并且在第一部件在皮肤上保持固定的同时使外壳朝皮肤运动。这样,引导件能够对注射装置通过引导件的进展施加某种控制。
第二部件可以适于相对于第一部件按分度运动。这允许使用者更准确地控制注射装置的运动。
例如,引导件还可包括设置在其内表面上的棘轮,从而使得外壳朝使用者的皮肤递增地运动。棘轮可以存在于第一和第二部件之间,或者在第一部件和外壳自身之间。这第二种布置允许使用者控制注射装置的运动,而不需要第二部件。在任何情况下,棘轮防止注射装置在注射装置已朝使用者的皮肤推进时被从引导件移除,这提供了改善的安全性。
第二端可被构造成能够将使用者的皮肤向上拉入第二端中。例如,第二端可包括具有特定形状的孔,这造成孔中的皮肤被夹住,并因此朝注射装置的远端升高。该皮肤构型有利于皮下注射。
第二端可包括被向内偏压的弹性部分。当第二端被置于皮肤上时,该弹性部分用来将皮肤夹在一起。弹性部分可包括被朝彼此偏压的至少两个弹性臂,所述臂对于将皮肤夹在一起特别有效。
在本发明的第二方面,提供了一种包括前述任何实施例的引导件和具有外壳的自动注射装置的套件。
引导件的第一端可以适于在其远端处接合外壳。引导件的尺寸可被设计成配合预存在的注射装置,以确保该引导件是易于兼容的。
外壳可具有第一直径,并且第一端的尺寸可被设计成围绕第一直径。外壳由此容易插入外壳的第一端中。优选地,第一端的尺寸被设计成使得在外壳和引导件之间存在过盈配合。
引导件的内表面的尺寸可被设计成与外壳的外表面并置接触。这确保当外壳被推进通过引导件时外壳与引导件的壁保持对齐。
外壳的一部分可具有比第一直径大的第二直径,并且第一端的尺寸可被设计成接合具有第二直径的外壳的部分。第二直径部分防止外壳比所需的更远地朝皮肤推进。
第二直径部分可包括脊,例如以充当外壳相对于引导件的止挡件。
第一端与注射装置的外壳可为一体的。因此,注射装置和外壳可以表现为一体的。
在本发明的第三方面,提供了一种注射装置,该注射装置包括:外壳,该外壳适于接收具有排放喷嘴的注射器,该注射器能够在注射装置致动时在外壳中沿纵向轴线从回缩位置和伸出位置运动,在回缩位置,排放喷嘴被包含在外壳中,在伸出位置,注射器的排放喷嘴从外壳延伸穿过在所述装置的远端处的出口孔;滑动部件,该滑动部件在处于第一位置时从所述孔延伸,并且能够朝外壳运动至第二回缩位置;以及引导件,该引导件用于使注射装置与使用者接触,该引导件具有适于接合外壳的第一端和适于接合使用者的皮肤的表面的第二端,其中引导件允许外壳朝使用者的皮肤运动。
注射装置还可包括致动器和驱动器,该驱动器适于由致动器作用并且继而作用于注射器,以将注射器从其回缩位置推进至其伸出位置,并且通过排放喷嘴排出注射器的内容物。
滑动部件可以是锁定机构的一部分,该锁定机构能够从当滑动部件处于其第一位置时的接合位置运动至当滑动部件处于其第二位置时的脱离位置,并且适于在锁定机构处于其接合位置时防止所述装置的致动,并在锁定机构处于其脱离位置时允许所述装置的致动。
当外壳抵靠皮肤运动时,滑动套管可运动至其脱离位置。引导件确保注射装置处于正确的角度,以进行此运动。
上述实施例中任一项的注射装置或注射套件可以包含选自由以下项构成的组的物质:戈利木单抗、激素、抗毒素、用于控制疼痛的物质、用于控制血栓形成的物质、用于控制或消除感染的物质、肽、蛋白、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、抗过敏剂、抗组胺剂、抗炎剂、皮质类固醇、病情改善抗风湿药、促红细胞生成素或疫苗,以用于在类风湿性关节炎、银屑病性关节炎、强直性脊柱炎、溃疡性结肠炎、激素缺乏症、毒副作用、疼痛、血栓形成、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、癌症、黄斑变性、过敏、花粉症、发炎、贫血或脊髓发育不良的治疗或预防中或者在保护性免疫的表达中使用。
所谓“注射装置或注射套件可以包含一物质”是指,该物质可以包含在诸如小瓶或注射器的合适的药物容器内,在注射装置内,或在注射套件的注射器内。这样的药物容器可以包含其他物质,例如另外的活性或非活性成分。
在本发明的另一方面,提供了一种物质,该物质选自由以下项构成的组:戈利木单抗、激素、抗毒素、用于控制疼痛的物质、用于控制血栓形成的物质、用于控制或消除感染的物质、肽、蛋白、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、抗过敏剂、抗组胺剂、抗炎剂、皮质类固醇、病情改善抗风湿药、促红细胞生成素或疫苗,以用于通过使用根据上述实施例中任一项的注射装置或注射套件将所述物质递送至人类受治疗者而在类风湿性关节炎、银屑病性关节炎、强直性脊柱炎、溃疡性结肠炎、激素缺乏症、毒副作用、疼痛、血栓形成、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、癌症、黄斑变性、过敏、花粉症、发炎、贫血或脊髓发育不良的治疗或预防中或者在保护性免疫的表达中使用。
在本发明的又一方面,提供了一种注射装置,该注射装置用于通过使用该注射装置将物质递送至人类受治疗者而在类风湿性关节炎、银屑病性关节炎、强直性脊柱炎、溃疡性结肠炎、激素缺乏症、毒副作用、疼痛、血栓形成、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、癌症、黄斑变性、过敏、花粉症、发炎、贫血或脊髓发育不良的治疗或预防中或者在保护性免疫的表达中使用,所述物质选自由以下项构成的组:戈利木单抗、激素、抗毒素、用于控制疼痛的物质、用于控制血栓形成的物质、用于控制或消除感染的物质、肽、蛋白、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、抗过敏剂、抗组胺剂、抗炎剂、皮质类固醇、病情改善抗风湿药、促红细胞生成素或疫苗,其中注射装置是上述实施例中任一项的注射装置或注射套件。
所谓“递送物质”是指,注射装置用来例如通过皮下注射、真皮内注射或肌内注射将所述物质注射到人类受治疗者体内。所述物质可以结合诸如另外的活性或非活性成分的其他物质施用。
附图说明
现在将结合附图描述本发明,在附图中:-
图1示出了注射装置的透视图,该注射装置具有包括滑动套管的锁定机构;
图2示出了注射装置的剖面侧视图,该注射装置具有包括滑动套管的锁定机构;
图3示出了注射装置的侧视图,该注射装置具有包括滑动套管的锁定机构;
图4a示出了本发明的引导件和注射装置的透视图;
图4b示出了根据本发明的另选引导件的透视图;
图5a示出了根据本发明的另选引导件的剖视图;
图5b示出了根据本发明的另选引导件的剖视图;以及
图6示出了根据本发明的引导件的剖视图。
具体实施方式
图1至3示出了注射装置110。注射装置110具有注射装置外壳112和纵向轴线101。
注射器(图3)被包含在外壳112中。注射装置110包括触发器114(致动器)和可释放的锁定机构116。触发器114具有第一端114a和第二端114b。触发器114可围绕枢轴115从静止位置(如图2所示)旋转至活动位置。触发器114的第二端114b与传动联轴器121相连,传动联轴器121由驱动弹簧120来作用。传动联轴器121与注射器122连通。
触发器114围绕枢轴115在方向R上(即,在触发器114的第一端114a处向下进入外壳112)的旋转造成触发器114的第二端114b脱离传动联轴器121,从而让驱动弹簧120沿纵向轴线101且向外壳112中的孔118之外驱动注射器122(经由传动联轴器121)。
可释放的锁定机构116与滑动套管126连通,滑动套管126在处于第一位置时从外壳112中的孔118突出。通过将滑动套管126沿纵向轴线101运动至外壳112内而将锁定机构116停用到第二位置。
滑动套管126的第一端126a可抵靠药物所递送进的身体放置,从而停用可释放的锁定机构116,并允许触发器114在方向R上从其静止位置旋转至其活动位置。
触发器114在其第一端114a处设有具有切口的第一部分。第一部分在基本上平行于纵向轴线101的方向上从触发器114a的第一端114a延伸。
可释放的锁定机构116包括突起154,突起154在沿垂直于纵向轴线101的垂直轴线181的方向上突出。切口的尺寸被设计成接收突起。
当可释放的锁定机构116处于其第一位置时,突起的端部邻接第一部分150的下表面,从而防止触发器114旋转。
当可释放的锁定机构116在滑动套管126运动至外壳112内之后处于其第二位置(未示出)时,切口定位在突起154的端部上方,以允许该切口在向下的力被施加到触发器114时越过突起154。因此,触发器114不再被阻止旋转,并且自身脱离传动联轴器121,从而使注射器延伸。
图4a示出了根据本发明的引导件200。引导件包括圆柱形部分,该圆柱形部分在引导件的第一端210和第二端220处均为开放的。引导件是朝第二端扩张的。另选地,如图4b所示,引导件200的第二端220可以是圆柱形的。第一端210的尺寸被设计成接收注射装置的外壳112,例如图1至3中所示。引导件200的第一端210的尺寸可被设计成使得具有比外壳112的第二部分140大的第二直径的外壳112的第一部分130不能穿过引导件。当注射装置被推进通过引导件200时,第一部分接合外壳112的第一端210。这在外壳被推进时为外壳提供了止挡件,从而使得外壳不能被抵靠皮肤推动得比所需更远。另选地,脊可以设置在外壳112上,一旦注射装置110已被充分推进,脊就接合引导件200的第一端210。
在使用中,引导件200的第二端220附接到使用者的皮肤,如图4a所示。第二端220的扩张形状用来将引导件200以正确的角度定位到使用者的皮肤,并且确保引导件在该位置是稳定的。注射装置110被插入引导件的第一开放端210中。引导件200用来将注射装置110以正确的角度朝使用者的皮肤导向,从而使得当滑动套管126接触使用者的皮肤时,力被均匀地施加在滑动套管126的周边周围,并且滑动套管126被正确地运动至其回缩位置,从而使使用者能够致动注射装置110。
在图4a中,引导件具有连续的外表面230。另选地,引导件可以由框架形成,从而使得当注射装置被朝皮肤运动时使用者能看到滑动套管的运动。
作为对扩张端的另选形式,如图4b所示,突起250可以设置在引导件200的第二端220处,该突起在引导件200被置于皮肤上之后使引导件200稳定。突起250可以充当三脚架,并且在注射装置被操作时防止引导件倾斜。
图5a示出了引导件300的另选实施例,该引导件包括在引导件的内表面上的棘轮机构350。当外壳112被插入第一开放端310中并朝皮肤运动时,棘轮350接合注射装置110的外壳112的表面。注射装置110可由此在滑动套管126接触皮肤时朝使用者的皮肤递增地运动,并且从其伸出位置运动至其回缩位置。这允许使用者准确地判断注射装置110已被推进到多远。由此,一旦锁定机构已被停用,注射装置110就不能被从引导件300和因此皮肤移除。
另选地,如图5b所示,棘轮机构可以是两部件机构,其包括第二可运动部件,该第二部件接合外壳并相对于引导件的第一部件以按分度方式运动。第二部件可以是通过摩擦配合接合外壳的环形部件。在未示出的另一个实施例中,棘轮可以被省略,从而使得第二部件可以相对于第一部件滑动。
图6示出了引导件的另选实施例,其中第二开放端410包括两个臂440。臂440被朝引导件的中心弹性地偏压,从而使得臂在被放置在使用者的皮肤上时用来将组织夹在它们之间。这将引导件400固定到使用者的皮肤,并且确保在注射装置被穿过驱动器且朝着皮肤推进和随后操作时引导件不能偏移位置。此外,当物质将被皮下注射时,皮肤朝装置110的孔118(排放喷嘴从该孔延伸)的紧缩是可取的。
可以提供一种套件,该套件包括注射装置和在注射之前附接到使用者的引导件。另选地,注射装置可以在引导件被预附接到远端的情况下提供。
在使用中,如上所述的注射装置可能用来递送诸如下列的物质:戈利木单抗、激素、抗毒素、用于控制疼痛的物质、用于控制血栓形成的物质、用于控制或消除感染的物质、肽、蛋白、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、抗过敏剂、抗组胺剂、抗炎剂、皮质类固醇、病情改善抗风湿药、促红细胞生成素或疫苗,以用于在类风湿性关节炎、银屑病性关节炎、强直性脊柱炎、溃疡性结肠炎、激素缺乏症、毒副作用、疼痛、血栓形成、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、癌症、黄斑变性、过敏、花粉症、发炎、贫血或脊髓发育不良的治疗或预防中或者在保护性免疫的表达中使用。除了这些物质之外,包含在注射装置内的任何药物也可包括技术人员了解的其他物质,例如非活性成分。
当然,本领域的技术人员应当理解,特定的物质有效地用于治疗或预防特定的病症,如本领域所熟知的。例如,已知的是,抗过敏剂有效地用于治疗或预防过敏;抗组胺剂有效地用于治疗或预防花粉症;抗炎剂有效地用于治疗或预防发炎;等等。因此,可以设想出此处或权利要求书中列举的用于在已知所述物质对其有功效的一种或多种病症的治疗或预防中使用的一种或多种物质的任何选择。
然而,在特定的例子中,已知戈利木单抗被有效地用于治疗或预防类风湿性关节炎、银屑病性关节炎、强直性脊柱炎或溃疡性结肠炎中的一者或多者或类风湿性关节炎、银屑病性关节炎、强直性脊柱炎和溃疡性结肠炎的任意组合或类风湿性关节炎、银屑病性关节炎、强直性脊柱炎和溃疡性结肠炎中的全部。
戈利木单抗可以可任选地结合诸如下列中的任一种或全部的一种或多种非活性成分使用:L-组氨酸、L-组氨酸单盐酸盐一水合物、山梨醇、聚山梨醇酯80和水。戈利木单抗可以存在于其中戈利木单抗是唯一的活性成分的组合物中。例如,戈利木单抗可以作为施用。
当然,应当理解,上文纯粹以举例方式描述了本发明,在本发明的范围内可以做出细节上的修改。

Claims (24)

1.一种用于使注射装置与使用者接触的引导件,所述引导件具有适于接合所述注射装置的外壳的第一端和适于接合使用者的皮肤的表面的第二端,其中所述引导件允许所述外壳朝所述使用者的皮肤运动,引导件还包括设置在其内表面上的棘轮,从而使得所述外壳朝所述使用者的皮肤递增地运动。
2.根据权利要求1所述的引导件,其中所述第一端和/或所述第二端为开放的。
3.根据权利要求1所述的引导件,其中所述引导件为圆柱形的。
4.根据权利要求1所述的引导件,其中所述引导件朝所述第二端扩张。
5.根据权利要求1-4中任一项所述的引导件,其中所述引导件被制成框架。
6.根据权利要求1-4中任一项所述的引导件,其中所述引导件形成有连续的外表面。
7.根据权利要求1-4中任一项所述的引导件,其中所述引导件包括在其第二端处的至少一个稳定元件,所述至少一个稳定元件适于从所述引导件突出并且将所述引导件稳定在所述皮肤上。
8.根据权利要求7所述的引导件,其中所述引导件包括在其第二端处的三个稳定元件。
9.根据权利要求1-4中任一项所述的引导件,包括第一部件和能够相对于所述第一部件运动的第二部件。
10.根据权利要求9所述的引导件,其中所述第二部件适于相对于所述第一部件按分度运动。
11.根据权利要求1-4中任一项所述的引导件,其中所述第二端被构造成能够将所述使用者的皮肤拉入所述第二端中。
12.根据权利要求11所述的引导件,其中所述第二端包括被向内偏压的弹性部分。
13.根据权利要求12所述的引导件,其中所述弹性部分包括被朝彼此偏压的至少两个弹性臂。
14.一种包括根据前述权利要求中任一项所述的引导件和具有外壳的自动注射装置的套件。
15.根据权利要求14所述的套件,其中所述第一端适于接合所述外壳。
16.根据权利要求14所述的套件,其中所述外壳具有第一直径,并且所述第一端的尺寸被设计成围绕所述第一直径。
17.根据权利要求16所述的套件,其中所述引导件的所述内表面的尺寸被设计成与所述外壳的外表面并置接触。
18.根据权利要求16所述的套件,其中所述外壳的一部分具有比所述第一直径大的第二直径,并且所述第一端的尺寸被设计成接合具有第二直径的所述外壳的所述部分。
19.根据权利要求18所述的套件,其中所述第二直径部分包括脊。
20.根据权利要求14至19中任一项所述的套件,其中所述第一端与所述注射装置的所述外壳是一体的。
21.一种注射装置,所述注射装置包括:
外壳,所述外壳适于接收具有排放喷嘴的注射器,所述注射器能够在所述注射装置致动时在所述外壳中沿纵向轴线从回缩位置运动至伸出位置,在所述回缩位置,所述排放喷嘴被包含在所述外壳内,在所述伸出位置,所述注射器的所述排放喷嘴从所述外壳延伸穿过在所述装置的远端处的出口孔;
滑动部件,所述滑动部件在处于第一位置时从所述孔延伸,并且能够朝所述外壳运动至回缩的第二位置;以及
根据权利要求1所述的引导件。
22.根据权利要求21所述的装置,所述装置还包括:
致动器;以及
驱动器,所述驱动器适于由所述致动器作用并且继而作用于所述注射器,以将所述注射器从其回缩位置推进至其伸出位置,并且通过所述排放喷嘴排出所述注射器的内容物。
23.根据权利要求21所述的装置,其中所述滑动部件是锁定机构的一部分,所述锁定机构能够从当所述滑动部件处于其第一位置时的接合位置运动至当所述滑动部件处于其第二位置时的脱离位置,并且适于在所述锁定机构处于其接合位置时防止所述装置的致动,并在所述锁定机构处于其脱离位置时允许所述装置的致动。
24.根据权利要求14至19中任一项所述的套件或根据权利要求21至23中任一项所述的注射装置,其中所述注射装置包括戈利木单抗,以用于在类风湿性关节炎、银屑病性关节炎、强直性脊柱炎或溃疡性结肠炎的治疗或预防中使用。
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