CN108367114A - 具有流体路径和驱动器的注射设备 - Google Patents

具有流体路径和驱动器的注射设备 Download PDF

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CN108367114A
CN108367114A CN201680059090.9A CN201680059090A CN108367114A CN 108367114 A CN108367114 A CN 108367114A CN 201680059090 A CN201680059090 A CN 201680059090A CN 108367114 A CN108367114 A CN 108367114A
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fluid path
cylindrantherae
needle body
injection
equipment
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CN108367114B (zh
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O·卡比里
P·H·诺顿
R·希斯基安胡
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Western Medicine Services To Israel Branch
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Western Medicine Services To Israel Branch
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Abstract

一种用于药物注射的设备，其具有药筒，所述药筒又具有储存器和流体路径。流体路径运载用于从储存器注射到待注射患者处的流体。流体路径包括针体，并且流体路径保持无菌。驱动链将针体延伸到注射点，但仅与流体路径机械连接以操作针体，该机械连接使得在维持流体路径无菌的同时操作针体。

Description

具有流体路径和驱动器的注射设备
技术领域和背景技术
本发明在其一些实施例中涉及一种注射设备，其具有用于待注射材料的流动路径以及用于伸出和缩回针体的驱动机构，更具体地但非排他地涉及用于确保流体路径无菌的布置。
约瑟夫格罗斯(Joseph Gross)等人转让给伊兰制药国际有限公司(Elan PharmaInternational Limited)的美国专利6,843,782公开了一种注射设备，其具有限定皮肤接触表面的基座构件、用作药物储存器的注射器以及用于将药品从注射器排出的设备。注射器连接到基座构件，使得注射器的纵向轴线大致平行于皮肤表面。输送针体与注射器连通。针体具有成角度的弯曲，其引导针体的尖端基本上垂直于皮肤接触表面。在使用中，针体的尖端适于穿透对象的皮肤。
在所述的设备中，流体路径从注射器延伸到针体并且与针体呈直线联接，并且处于设备被插入到填充设备中用于装载待注射材料的这种状态。针体保持笔直并且在从填充设备中取出时被针帽覆盖。随后，针体在充满流体的同时弯曲，并且弯曲针体是不可逆的。
因此，如果所引用的设备被拆卸并且药筒/流体路径被移除，则其不能被恢复到刚填充之后的原始状态。因此，如果注射材料到期或需要召回设备，例如发现批次被污染，则设备不能被清空并重新填充以供使用。
所述的设备的另一个缺点是在药筒已满时弯曲针体，导致来自针体的金属颗粒被释放到注射材料中。在现有的自动填充过程的传统颗粒测试过程中，不会被检查出。金属颗粒损害了注射材料的纯度，因此这种设备无法获得使用许可。
发明内容
本实施例提供了在填充之前针体弯曲的流体路径。流体路径的完整性与药筒或储存器保持一致，并且只要注射器没有被使用，药筒可以被更换。可以提供可移除的盖体以便于这种移除。
本实施例确保与针驱动机构隔离的无菌流体路径。在实施例中，驱动机构本身不是无菌的。因此，如果驱动机构出现故障，则流体路径可作为整体被抽出并放置在不同的设备中，或者在某些情况下，驱动机构可被固定，而不损害流体路径的无菌性。
流体路径和驱动机构之间的连接可以是纯机械的。其中一个后果就是机械部分和生物活性流体部分可以分离以进行更加环保的处理。
流体路径是无菌的，而驱动机构和设备的其余部分可能不是。因此，当注射设备直接放置在患者的皮肤上用于注射时，注射剂的无菌性不会受到损害。
本实施例允许易于操作。特别是自我注射的患者通常将设备放置在他或她的一只手臂上。在这种情况下，只有一只手可用于操作该设备。在本实施例中，一旦用一只手抓住该设备，就可以用从前向后的一个动作移动针罩和粘附剂，并且不需要改变设备上的保持位置(这将需要双手)。
该设备可以被设计成类似于电脑鼠标以被单手的手指抓握，并且如同电脑鼠标一样，抓握手指位于致动针体的正确位置。从前到后或从后到前的单次剥离(peeling)运动中也可以拆除该设备。
根据本发明的一些实施例的一个方面，提供了一种用于药物注射的设备，包括：
药筒，所述药筒具有纵向轴线并且可移动地安装在所述设备中以使所述纵向轴线旋转或使所述纵向轴线线性移位，并且包括储存器和流体路径，所述流体路径用于将注射的流体从储存器运送至患者的注射点，所述流体路径包括针体，所述针体与所述轴线成非零(finite)角度，所述流体路径被无菌密封；
驱动链，所述驱动链用于通过所述旋转或线性移位来移动所述药筒，以将所述针体延伸到所述注射点，所述驱动链机械地连接到所述流体路径以移动所述药筒，所述机械连接用以在保持流体路径无菌的同时执行所述旋转或线性移位。本文示出的实施例示出了药筒被旋转，但是其同样可以被安装成朝向基座滑动。
在一个实施例中，流体路径被预成型以包含角度，该角度例如可以是直角。
在一实施例中，机械连接被设计成允许驱动链与所述流体路径分离，同时保持所述流体路径无菌。
一实施例可包括壳体和用于操作所述驱动链的按钮，所述壳体的形状和尺寸被设置成单手握持，所述按钮被定位成通过所述单手握持的手指来操作。
一实施例可包括前端和后端以及用于附着到所述患者的皮肤以进行所述注射的粘附层。
所述设备通过使用所述单手握持和所述前端与所述后端之间的滚动运动经借由所述粘附层可附接至患者和可从患者拆离。
一实施例可包括位于所述壳体中的盖体，所述盖体可移除以允许所述储存器借由所述壳体移除。
在一个实施例中，储存器可与流体路径一起移除。
根据本发明的第二方面，提供了一种用于在注射器设备中填充、装载和移除药筒的方法，其中所述药筒纵向与接受注射的患者皮肤平面保持一定角度，所述方法包括：
获得药筒，所述药筒附接流体路径，用于将流体从所述药筒运送到注射部位；
向所述流体路径增加角度，使得所述流体路径在所述药筒的纵向轴线上离开所述药筒并且垂直于所述平面被输送至所述患者；在增加角度之后，用注射流体填充药筒；
将所述药筒与所述流体路径一起装载到所述注射设备中；和
所述注射设备移除所述药筒和流体路径。
一实施例包括一旦注意到所述注射设备中的故障后执行所述移除，并将所述药筒置于第二注射设备中。
一实施例包括一旦注意到所述储存器中的故障，执行所述移除，并将另一个药筒放置在所述注射设备中。
一实施例包括提供用于所述注射设备的壳体和在所述壳体中的可移除盖体并打开所述可移除盖体以执行所述装载和所述移除。
在一实施例中，所述装载所述药筒包括放置所述流体路径与驱动机构机械连接，所述驱动机构将所述流体路径的针体延伸到所述患者上的注射部位。
在一实施例中，所述流体路径是无菌的，所述方法包括施加和移除所述机械连接，同时保持所述流体路径无菌。
除非另外定义，否则本文使用的所有技术和/或科学术语具有与本发明所属领域的普通技术人员通常理解的相同的含义。尽管在本发明的实施例的实践或测试中可以使用与本文所述的方法和材料类似或等同的方法和材料，但是下面描述示例性的方法和/或材料。如果发生冲突，将控制包括定义在内的专利说明。另外，这些材料、方法和实例仅是说明性的，并非意在限制。
附图说明
本文仅通过举例的方式参照附图来描述本发明的一些实施例。现在具体参照附图详细说明，需强调所示出的细节是作为示例并且出于对本发明的实施例的说明性讨论的目的。就此而言，对于本领域技术人员来说，利用附图进行的描述对于可以如何实施本发明的实施例是显而易见的。
在附图中：
图1是根据本发明实施例示出按钮操作的注射设备、药筒和可移除盖体的简图；
图2是示出图1的注射设备的上部立体图的简化图，其中盖体和筒体渲染为透明；
图3是从下面看的立体图，示出了图1的注射设备，其中底座被移除并且示出了针驱动链的元件；
图4是示出图1的设备的针驱动链的元件的简化框图；
图5-11是示出图4的元件的不同实施方式中的针驱动链的简化图；
图12-17是示出使用图2的设备的注射过程中的不同阶段的简化图并且示出驱动链的不同状态；
图18是示出具有弯曲流体路径的图2的药筒的简化图；
图19是图18的流体路径的剖视图；
图20是示出根据本发明的一个实施例的药筒填充和更换过程的流程图；和
图21是示出根据本发明实施例的第二药筒填充和更换过程的流程图。
具体实施方式
本发明在其一些实施例中涉及一种注射设备，其具有用于待注射材料的流动路径以及用于伸出和缩回针体的驱动机构，更具体地但非排他地涉及用于确保流路无菌性的布置。
在详细解释本发明的至少一个实施例之前，应当理解的是，本发明在其应用中不一定限于后文描述和/或附图和/或示例中阐述的组件的构造和布置和/或方法的细节。本发明能够具有其他实施例或以各种方式实践或执行。
现在参考附图，图1示出了用于药物注射的设备10。设备10包括药筒12、从外侧覆盖设备的壳体14和装配到壳体14上的可移除盖体16。盖体12可移除以允许药筒出入，以供插入或移除。
药筒12具有用于保存待注射流体的桶形储存器18和用于将流体从储存器18运送到注入点的流体路径20。流体路径包括位于针盖22下方的针体(在该图中未示出)。流体路径通过与设备密封而保持无菌，并且与设备的唯一接触是机械接触，其通过密封件起作用而不损害密封的完整性并因此不损害无菌性。因此，设备10作为整体不需要无菌。因此，可以插入和取出药筒而不影响其无菌性。
齿轮24通过机构(通常为电动机)接合以推动筒体内的柱塞以执行注射。药筒上的啮合框架26与设备内的约束凹槽25接合以正确定位药筒。
现在参考图2，图2是示出图1的设备的变体40的简化图，其中驱动链将针体延伸到注射点。也就是说，该设备以针头回缩的状态被放置在使用者的皮肤上，并激活驱动链以将针头向下推到使用者的皮肤下。壳体的上部和药筒的上部透明以显示驱动链的各个部分。
驱动链机械连接到流体路径以操作针体。机械连接简单地从外部推动流体路径并且不损害流体路径内的无菌性。从而机械连接在保持流体路径无菌的情况下操孔针体。
现在参照图2描述驱动链的一个非限制性实施例。图2的实施例基于盘簧，但是也可以使用基于其他张力源、电动马达、使用者按压以及其他机构的实施例。药物输送设备包括上纵向表面42和下纵向表面44，其中下纵向表面44旨在抵靠皮肤放置。储存器46含有待注射的药物，并且柱塞48将药物排空到用于注射的针体中。柱塞由包括小型电动机50和电池52以及运动转换布置54的柱塞操作机构操作。针体插入机构56位于药物输送设备40的前端58处，以将针体60插入患者的皮肤中并且随后撤回针体。
可以设置运动源来操作针体60。运动源在一个实施例中可以是张紧轮62。在其他实施例中，柱塞可以被弹簧推动。张紧轮可以包括中断轮运动的两个凸耳64和66。
运动源的用户操作的控制器可以包括按钮68。应该注意的是，按钮可以是可压缩的独立组件，或者它可以是可被按压的壳体的柔性部分。当该按钮被按下一次时，第一凸耳64被释放，允许轮旋转半圈。半圈的运动转换为针体60的插入运动，从而插入针体。在一个实施例中，按钮68是与设备壳体分离的组件，使得壳体遮蔽按钮以免意外按压。为了触碰按钮，壳体的盖体部分可以被降低，从而提供两级激活系统并增加设备的安全性。
然后第二凸耳66用作中断器，从而使轮运动停止在针体插入运动完成的预设位置处。因此第二凸耳将轮运动分成第一运动部分和第二运动部分，这两个运动部分彼此连续。
可在按钮68的另一侧设置第二轮(在本图中不可见)，以提供更平衡的运动。
当轮第二次释放时，它在完全旋转的第二部分上从第二凸耳旋转到的第一凸耳，并且该运动转化为针体的缩回。
在一个替代实施例中，针体可以不缩回，而是当该设备从皮肤移除时基座可延伸以遮蔽针体。
可选地或附加地，针体缩回的线性运动可以例如借助于多个致动器或弹簧以相反的方向移动针体。在一些实施例中，致动按钮可以返回到原始位置和/或在注射后被锁定。
可选地或另外地，针体缩回可以由开关致动。例如，可以存在针体缩回开关和/或在针体插入后，致动按钮可以被重新用作针体缩回开关。
下文将更详细讨论的运动转换机构将轮或连续运动的任何其他源连接到针体60。运动转换机构可以在第一运动部分期间插入针体，并且可以在第二运动部分期间缩回针体。
在轮作为运动源的情况下，运动的连续性是不平滑(angular)的。
如下文将讨论的，代替或除了具有凸耳的轮子之外，还可以使用适当形状的凸轮。
因此，设备具有一个壳体和操作驱动链的按钮68，这在下文将更详细地描述。这种壳体的形状和尺寸可以用单手握持，就像电脑鼠标的设计一样。按钮定位成在单手握住时，可用单手握住的手指操作按钮。
该设备可以在基座具有粘附层以附着到患者的皮肤上，从而在注射期间约束该设备。对于某些注射，可能需要缓慢注射，因此设备需要在相同位置持续几分钟。优选地，可借由粘附层通过使用单手握持和设备前后之间的滚动运动来附接和拆卸设备。因此该设备被牢固地定位和粘附，然后在使用后剥离(peeled)。
如上所述，盖体16可为可移除的，以允许借由壳体中形成的开口装载和移除储存器。
移除整个药筒，从而取出具有附属的流体路径的储存器。
现在参考图3，该图是示出轮如何经由销70连接到设备40的盖体的简易图。
凸耳62和64是可选的并且在一些实施例中可以省略。但是需要一个元件其负责防止在使用前将盖体降低。这样的元件可以是按钮与结构(基座/盖体)或轮凸耳62,64或销70之间的触点。当轮保持在低位或伸出位置时，第二个元件或触点负责防止移动。再次，该特征可以通过安全闩凸耳与轮销之间的触点来提供。第三个元件/触点负责在行程结束时停止运动，从而确保一旦缩回，针头就不能再次伸出。这种特征可以通过轮凸耳或轮销与结构之间的触点来提供。
现在参考图4，图4是示出其中运动源是直接与运动转换单元82连接的螺旋弹簧80的实施例的简化图。运动转换单元包括一系列杠杆，其将弹簧80的旋转展开转化为针体84的下降和上升部分运动。也就是说，当弹簧展开时，运动分为两部分，一部分转换为第一方向，另一部分转换为第二相反方向。
现在参考图5。在图5中，运动源是由螺旋弹簧92张紧的柱塞90。柱塞由螺旋弹簧92线性地推动并枢转地附接到围绕轮96旋转的梁94。梁(beam)94枢转地连接到凸轮98，凸轮98又枢转地连接在枢转点100处，使得初始行程向下并且随后行程向上。当柱塞被螺旋弹簧推动时，运动被分成两部分，一部分转化到第一方向，另一部分转化到第二相反方向，如箭头102所示。
现在参考图6，其是运动转换机构的替代实施例。运动源仍然是由螺旋弹簧92张紧的柱塞90。柱塞由螺旋弹簧92线性地推动并且在枢轴93处枢转地附接到使凸轮98旋转的梁94。由于配件的限制，轮首先以单向转动，然后以相反的方式转动，如箭头102所示。
现在参考图7，其是运动转换机构的另一替代实施例。运动源仍然是由螺旋弹簧92张紧的柱塞90。柱塞在这种情况下由螺旋弹簧92旋转并且柱塞上具有成形的狭缝104。沿着纸张向外的方向延伸的销106位于狭缝中，从而使轮在相对于图像呈90度的平面首先转向一个方向，然后再转向另一个方向。
现在参考图8，图8示出了图5的变体，其中螺旋弹簧110操作柱塞112以使枢接的凸轮114在成角度的梁(angled beam)116上滑动。凸轮114在枢转点118处枢转。当柱塞移动时，运动被分成两部分，一部分转换到第一方向，另一部分转换到第二相反方向，如箭头120所示。
现在参考图9，图9是图6的实施例的变体的简化图。在图6中，螺旋弹簧130自身在枢转点132处枢转并且操控柱塞134以将凸轮136推靠在斜角梁138上。凸轮136在枢转点140处枢转。当推动柱塞时，运动被分成两部分，一部分换换到第一方向上，另一部分转换到相反的第二方向上，如箭头142所示。
现在参考图10，其图示了本实施例的另一变体。在图10中，凸轮150在枢转点152处枢转并且预张紧齿轮154位于具有相应齿158的凹入部156中的凸轮内部。随着齿轮154旋转，运动被分成两部分，一部分转换到第一方向，另一部分转换到相反的第二方向，如箭头160所示。
现在参考图11，图11是示出图2的轮实施例的运动转换机构的简化图。凸轮170在枢转位置172处枢转。轮174由旋转器张紧并且具有在凸轮170内的狭槽178中移动的枢轴176。如箭头180所示，凸轮上下移动。轮由张紧的旋转器操控，该旋转器通常是螺旋弹簧，螺旋弹簧展开以使轮绕其轴线旋转。
现在参考图12至图17，其示出图2的实施例中的驱动链的操作的连续阶段的一系列图。图12是示出在使用之前根据本实施例的设备的初始状态的简化图。该设备具有盖体190、使用者可操作按钮192、张紧轮194和安全闩196。该设备在使用之前装有药物，并且按钮和盖体被锁定，使得按钮不能被按下并且盖体不能被压低。具体地，由于臂197位于按钮延伸部198下方，安全闩196可以阻止按钮的按压。
现在参考图13，该图是示出处于使用之前的状态的图12的设备的简化图。与图9中相同的部件被给予相同的附图标记，并且除了理解本图所需的情况以外不再描述。该设备在注射部位紧靠皮肤放置，其将安全闩196推向设备的基座，从而允许按压按钮。现在可以按压按钮，因为臂197已经向前旋转并且不再位于按钮延伸部198下方。然而，尽管现在可以按下按钮以释放针体，但是盖体190仍然被锁定。
因此，安全闩确保按钮不能被按压，除非注射器齐平放置在平坦表面上。安全闩机构不限于本实施例，而是适用于与患者皮肤齐平放置的任何种类的注射器。更一般地说，安全闩是一种锁定机构，用于防止针体在除了存在皮肤之外伸出，并且包括具有臂197的杠杆，即安全闩196，该杠杆以低于药物输送设备的预设角度插入手臂以防止用户操作的控制器(即按钮192)的运动使按钮无法操作。杠杆从图9所示的预定角度转移，因为存在皮肤而与基座齐平地按压，从而向前移动手臂并释放按钮。
图14是示出图12的设备的简化图，其中按钮192被按压以插入针体。与图12中相同的部件被给予相同的附图标记，并且除了理解本图所需的情况以外不再描述。按下按钮192并释放轮194以在张力作用下旋转并插入针体。
图15是示出了针体已经插入用于注射之后的图12的设备的简化图。与图12中相同的部件被给予相同的附图标记，并且除了理解本图所需的情况以外不再描述。轮194旋转了半圈并且针体198从该设备中延伸出来，从而进行注射。
图16是示出图12的设备的简化图，其中安全闩打开以将轮释放缩回。与图12中相同的部件被给予相同的附图标记，并且除了理解本图所需的情况以外不再描述。在图16中，当设备在使用后从皮肤上撤回时，安全闩196向下延伸，释放张紧轮194第二半圈。半圈撤回针体。在半轮结束时，轮被阻止，使得不可能进一步转动。
图17是示出使用后锁定的图12的设备的简化图。与图12中相同的部件被给予相同的附图标记，并且除了理解本图所需的情况以外不再描述。在图17中，抬起盖体190，再次锁定该设备，使得用过的针体不被暴露。
在上述实施例中，基座196充当机械距离传感器。可以通过改变其相对于本体的角度来使用基座196，以检测皮肤接近并且释放轮或轮上的中断器，从而检测到设备从使用者皮肤移除时引发第二运动部分。因此，在从使用者移除设备时，针体的缩回自动发生。如上所述，距离传感器是机械的，但也可以使用光传感器或红外距离传感器，并且电驱动轮释放。
图18和19是包括储存器部分或筒体242和流体路径201的注射器200的立体图和剖视图。根据本发明的实施例，流体路径包括成角度的延伸部236，该延伸部236安装在离开筒体242的圆柱形空腔232的中心轴线258的弯曲臂上。可选地，流体路径连接到筒体的空腔并穿过延伸部。可选地，弯曲臂被模铸和/或与筒体242形成为一体。例如延伸部236从筒体242的远端209突出。可选地，延伸部236和筒体242之间的连接偏向到筒体242的背侧239a。在一些实施例中，针帽204以与筒体242的轴线258大致成直角的方式安装在延伸部236上。例如帽204面向筒体242的腹侧239b。在一些实施例中，凸缘240可以被设置在注射器200的近端207上。例如，凸缘240可用于将筒体242悬挂在自动填充机的支撑托盘上。
在一些实施例中，注射器200可以包括不对称特征。例如，流体路径可以非中心地连接到筒体242的远端。例如延伸部236从筒体242的远端209突出。可选地，延伸部236和筒体242之间的连接偏向到筒体242的背侧239a。在一些实施例中，针帽204以与轴线258大致成直角的方式安装在延伸部236上。例如帽204面向筒体242的腹侧239b。可选地，延伸部236和/或帽204的安装件远离筒体242的腹侧239b。例如，使延伸部236和/或帽204的安装件远离可以有助于设计具有较低轮廓的设备(例如因为安装的长度不会增加设备的轮廓)。可选地，注射器200可以包括突片248和/或凹痕238和/或突起和/或切口244和/或斜面部分246，以便于将注射器200附接到药物输送设备。
在一些实施例中，可以使用凹痕和/或凹痕和/或突起来将注射器200和/或药筒定位在输送设备中。例如，凹痕238是圆锥形的并且可以与输送设备中的突起和/或凹痕相互作用，以将药筒的远端209定位成与输送设备对齐。例如，凹痕和/或突起可以包括销和/或匹配孔。斜面246和/或切口244和/或突片248可以可选地与输送设备中的互补部分相互作用。
在一些实施例中，连接在筒体242的空腔232和延伸部236之间的流体路径250可以穿过和/或被模铸到注射器200中。可选地(例如，如图19所示)，金属针体252形成流体路径250的一部分。可选地，通过在针体252内部具有整个路径来减少流体路径250中的死腔，从而避免塑料模具中的死腔的任何问题。例如，针体252的嵌入部分253形成至突出部分251的弯曲流体路径250。突出部分251可选地直接伸出延伸部236，与空腔的轴线258和/或筒体242的轴线232基本成直角。如上文所讨论的，可选地针体252的突出端为倾斜和/或削尖以便于插过对象的皮肤。
在一些实施例中，倾斜的针尖端254被定向成避免阻塞针体252，如上所述。例如，倾斜针尖端254的开口朝向远侧。在针尖254通过围绕注射器的近端枢转而插入到对象中的情况下和/或在针尖254接近被插入到对象中趋于行进(plow)的情况下，朝远侧面向开口可防止针体阻塞。
在一些实施例中，延伸部可以具有不均匀的横截面。例如在延伸部236的中央部分开窗口或形成约束通道237。可选地，约束通道237绕针支撑件形成，针支撑件在模铸过程中约束针体并且随后被移除。可选地，针体252的储存器端部可以由芯销支撑。例如，在图18中可以看到模铸注射器中由于芯销而留下的空间256。在模铸期间，芯销可选地阻挡针体252的中空部分，例如防止针体被模铸材料阻塞。
在一些实施例中，减小约束空腔232内针体252的端部的芯销的尺寸以减小模铸后留下的死腔256。例如，芯销可具有握住针体252的端部的凹面和/或圆锥形内表面。可选地或附加地，芯销可以具有能装入到针体252的中空部中的凸面和/或圆锥形表面。例如，芯销可以包括能装入到针体252中的内凸部和/或定位针体252的外凹部。在模铸之前，芯销的外凹部可定位针体252以将芯销的内凸部插入针体252的中空部中。然后，外凹部可在成型之前缩回。可选地，在模制期间，只有芯销的内部保留在模具中。在模铸之后，可选地移除内芯销，当药物从注射器排出时留下减小的死腔。
在一些实施例中，如所解释的，延伸部236具有I型梁(I-beam)横截面。可选地，肋部235偏离流体路径。例如，偏移量足以为流体路径250周围和/或肋部235之间的通道237留出空间。
在一些实施例中，延伸部236的末端包括针帽204的安装件。例如，安装件可以包括密封环260和/或锥形部分261。例如，密封环260可以对帽204的内部进行密封。在一些实施例中，这可以隔离针体252的突出部分251和/或保护其免受污染。例如，锥形部分261可以形成在肋部235中。在一些实施例中，锥形部分261可将帽204刚性地约束到延伸部236。可选择地，通过沿着延伸部236的轴线和/或沿着针体252的突出部分251的轴线拉动帽204和/或推动帽204，帽204可与延伸部236连接和/或断开。
因此，如图所示，流体路径可以包含角度。机械连接被设计成允许驱动链与所述流体路径分离，同时保持所述流体路径无菌。
现在参考图20，其示出了根据本发明实施例的填充、装载和更换药筒的方法。如所讨论的，药筒纵向保持与接受注射的患者皮肤平面成一定角度。在该方法中，获得具有流体路径的药筒300，并且在流体路径中形成一角度302。由于流体路径中的角度，药筒被注射流体填充304。然后，现密封以保持无菌状态的药筒被放置在注射设备中306，并且如果一切顺利并且没有故障308，则患者使用注射器来执行注射310。但是如果在注射器设备中存在故障，那么可移除盒312并将其插入另一注射设备中。这种程序在注射流体的成本远高于注射设备的成本的情况下是有用的。
现在参考图21，其示出了根据本发明的实施例的填充、装载和更换药筒的另一方法。如所讨论的，药筒纵向保持与接受注射的患者皮肤平面成一定角度。在该方法中，获得具有流体路径的药筒300，并且在流体路径中形成一角度302。由于流体路径中的角度，药筒被注射流体填充304。然后，现密封以保持无菌状态的药筒被放置在注射设备中306，并且如果一切顺利并且没有故障308，则患者使用注射器来执行注射310。但是如果药筒中存在故障，例如说已经过期并且药物已经失效，则可以移除药筒314并插入新药筒。
如上所述，通过移除可移除盖子而打开壳体中的开口进行移除。
将药筒装入注射器可涉及将流体路径放置成与驱动机构机械连接。驱动机构然后操作以将流体路径的针延伸至患者皮肤下方的注射部位。
流体路径可以是无菌的并且密封的，并且流体路径仅在外部与驱动链或机构接触，使得施加和移除机械连接可以在保持流体路径无菌性的同时进行。将可能具有生物活性物质的药筒与剩余的注射设备分离的能力意味着可以使用更环保的处置程序，并且允许在发生故障的情况下更药筒或注射器。
术语“包括”，“包括有”，“包含”，“包含于”，“具有”及其结合意味着“包括但不限于”。
术语“由...组成”表示“包括并限于”。
术语“基本上由...组成”是指组合物、方法或结构可以包括附加的成分、步骤和/或部分，但仅指附加成分、步骤和/或部分不会实质上改变要求保护的组合物、方法或结构的基本特征和新颖特征。
如本文所用，除非上下文另外明确指出，否则单数形式“一”，“一个”和“该”包括复数指代。
应该认识到，为了清楚起见，在单独实施例的上下文中描述的本发明的某些特征也可以在单个实施例中组合提供。相反地，为了简洁起见，在单个实施例的上下文中描述的本发明的各种特征也可以单独地或以任何合适的子组合或者在本发明的任何其他描述的实施例中合适地提供。除非实施例在没有那些元件的情况下不起作用，否则在各种实施例的上下文中描述的某些特征不被认为是那些实施例的基本特征。
尽管已经结合其具体实施例描述了本发明，但对于本领域技术人员而言，许多替代、修改和变化将是显而易见的。因此，旨在涵盖落入所附权利要求的精神和广泛范围内的所有这些替代、修改和变化。
本说明书中提及的所有出版物、专利和专利申请在此通过引用整体并入本说明书，其程度如同每个单独的出版物、专利或专利申请被具体和单独地指出通过引用并入本文。另外，本申请中任何参考文献的引用或标识不应被解释为承认这种参考文献可作为本发明的现有技术。在使用章节标题的范围内，不应将其解释为限制。

Claims (14)

1.一种药物注射设备，其特征在于，包括:
药筒，所述药筒具有纵向轴线并且可移动地安装在所述设备中以使所述纵向轴线旋转或使所述纵向轴线线性移位，并且包括储存器和流体路径，所述流体路径用于将注射的流体从储存器运送至患者的注射点，所述流体路径包括针体，所述针体与所述轴线成非零角度，所述流体路径被无菌密封；
驱动链，所述驱动链用于通过所述旋转或线性移位来移动所述药筒，以将所述针体延伸到所述注射点，所述驱动链机械地连接到所述流体路径以移动所述药筒，所述机械连接使得在保持流体路径无菌的同时执行所述旋转或线性移位。
2.根据权利要求1所述的设备，其特征在于，所述的流体路径预成型以包含一角度。
3.根据权利要求1所述的设备，其特征在于，所述的机械连接被设计成允许所述驱动链与所述流体路径分离，同时保持所述流体路径无菌。
4.根据权利要求1所述的设备，其特征在于，还包括壳体和用于操作所述驱动链的按钮，所述壳体的形状和尺寸被设置成单手握持，所述按钮被定位成通过所述单手握持的手指来操作。
5.根据权利要求4所述的设备，其特征在于，具有前端和后端以及用于附着到所述患者的皮肤以进行所述注射的粘附层。
6.根据权利要求5所述的设备，其特征在于，所述设备通过使用所述单手握持和所述前端与所述后端之间的滚动运动借由所述粘附层可附接至患者和可从患者拆离。
7.根据权利要求1所述的设备，其特征在于，还包括位于所述壳体中的盖体，所述盖体可移除以允许所述储存器借由所述壳体移除。
8.根据权利要求7所述的设备，其特征在于，所述储存器可从所述流体路径移除。
9.一种用于在注射设备中填充、装载和移除药筒的方法，其特征在于，所述药筒纵向与接受注射的患者皮肤平面保持一定角度，所述方法包括：
获得药筒，所述药筒附接至流体路径以将流体从所述药筒运送到注射部位；
为所述流体路径增加角度，使得所述流体路径沿所述药筒的纵向轴线离开所述药筒并且垂直于所述平面被输送至所述患者；
在增加所述角度之后，用注射流体填充所述药筒；
将所述药筒与所述流体路径一起装载到所述注射设备中；和
从所述注射设备移除所述药筒和所述流体路径。
10.根据权利要求9所述的方法，其特征在于，包括当注意到所述注射设备中的故障后执行所述移除，并将所述药筒置于第二注射设备中。
11.根据权利要求9所述的方法，其特征在于，包括当注意到所述储存器中的故障后执行所述移除，并将另一个药筒放置在所述注射设备中。
12.根据权利要求9所述的方法，其特征在于，包括提供用于所述注射设备的壳体和位于所述壳体中的可移除盖体并打开所述可移除盖体以执行所述装载和所述移除。
13.根据权利要求9所述的方法，其特征在于，所述装载所述药筒包括将所述流体路径放置成与驱动机构机械连接，所述驱动机构将所述流体路径的针体延伸到所述患者的注射部位。
14.根据权利要求13所述的方法，其特征在于，所述流体路径是无菌的，所述方法包括施加和移除所述机械连接，同时保持所述流体路径无菌。
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US15/269,248 2016-09-19
US15/269,248 US10086145B2 (en) 2015-09-22 2016-09-19 Rotation resistant friction adapter for plunger driver of drug delivery device
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CN201610882938.XA Active CN106964013B (zh) 2015-10-09 2016-10-10 成角度的注射器修补注入器
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