CN204445905U - 药剂输送装置和使用药剂输送装置的系统 - Google Patents
药剂输送装置和使用药剂输送装置的系统 Download PDFInfo
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Abstract
一种药剂输送装置(100),其包括:模制圆柱形筒管(106),在轴向方向上在筒管的表面上具有可见标记(112);柱塞(108),密封圆柱形筒管的远侧开口;模制针接口(104),布置在圆柱形筒管的近侧开口中,用来将针接口封接到筒管上。针(102)布置在针接口中,用来通过柱塞在轴向方向上的操作而连通液体。在针接口的凸缘上的圆周表面包括有色标记(118、146),该有色标记(118、146)与药剂输送装置或其内容物的特性相对应。
Description
对于相关申请的交互参考
本申请要求Amit Limaye等的、标题为“具有可见编码针接口的注射器”、序号为No.13/442,592、在2012年4月9日提交的美国非临时专利申请的权益,所述申请的全部内容通过参考包括在里。
技术领域
总体而言,本实用新型涉及注射器,更具体地说,涉及具有可见编码针接口的注射器,以指明针径、针长度、注射器类型等。
背景技术
对于糖尿病的一种胰岛素治疗模式是经一次性注射器注射胰岛素。一般而言,使用者将布置在注射器的针上的安全帽盖除去,用针刺入胰岛素容器的盖,进而抽出预定量的胰岛素,以制备胰岛素以便注射。使用者然后用针刺入他或她的皮肤,并且注射胰岛素。在注射胰岛素之后,将注射器丢弃。
常规一次性注射器一般包括:模制的圆柱形筒管;针接口,紧固到筒管上;以及针,布置在针接口中,以通过柱塞的操作,连通在筒管中布置的液体。注射器沿筒管标记有在筒管内布置的液体体积的可见指示符,以允许使用者抽出和注射正确体积的药剂。常规的模制针接口在组装之后没有分离地标记,使得难以确定针的性能。
在胰岛素治疗中,有对于使用者适用的不同胰岛素浓度。为了适应不同的胰岛素浓度,在注射器筒管上的标记可以与特定胰岛素浓度的胰岛素单位相对应。因此,如果两位同居胰岛素使用者具有不同的胰岛素要求,则或许可能的是,使用者之一无意地使用不正确的注射器,并且注射不正确的胰岛素剂量。
实用新型内容
本实用新型的实施例的目的是,大体消除以上和其它担心,并且提供改进的胰岛素注射装置。这些和其它目的大体通过如下方式而实现:提供模制的圆柱形筒管,在轴向方向上在筒管的表面上具有可见标记;柱塞,其具有塞子,该塞子连结到柱塞的端部上,以密封圆柱形筒管的远侧开口;以及模制针接口,布置在圆柱形筒管的近侧开口中,用来密封圆柱形筒管。
针接口包括凸缘,该凸缘具有圆周表面,该圆周表面包括可见编码标记,如颜色。标记与注射器的特性相对应,如与针径、针长度、注射器类型、药剂、或与在筒管表面上的可见标记相关联的药剂单位相对应。凸缘的圆周表面可以沿径向延伸超出筒管的表面,以允许注射器和其关联特性的容易识别。
在这里公开的一个例示性实施例中,通用针接口可以制造成没有针,并且具体注射器可以基于生产需要由通用针接口制成,由此便于制造。在另外的一些实施例中,将针与针接口相固定,并且在针接口的表面上标有可见标记,以标识针的特性而便于制造。
附图说明
当联系附图阅读如下详细描述时,将更容易认识本实用新型的一个例示性实施例的各种目的、优点及新颖特征,在这些附图中:
图1是按照本实用新型的一个例示性实施例的注射器的立体图;
图2是图1的注射器的部分视图,更详细地表示针接口;
图3是图1的注射器完全组装的侧视图,该注射器具有布置在针上的安全护套;
图4是按照本实用新型的一个例示性实施例的针接口的立体图;
图5是图1的注射器的近侧端部的横截面图;
图6是流程图,表示用来制造图1的注射器的例示性过程;
图7是按照本实用新型的一个例示性实施例的另一种例示性注射 器的立体图;
图8是流程图,表示用来制造图7的注射器的例示性过程;而
图9示出根据本实用新型的一个例示性实施例的胰岛素存储容器和零售包装。
具体实施方式
图1示出诸如塑料一次性注射器100之类的药剂输送装置的一个例示性实施例,该塑料一次性注射器100具有在其近侧端部处的并且布置在模制针接口104中的针102。如下面将描述的那样,将针接口104紧固到模制圆柱形筒管106的敞开近侧端部上,并且将柱塞108布置在圆柱形筒管106的敞开远侧端部处。柱塞108包括塞子110,该塞子110构造成密封筒管106的远侧端部。塞子110对于柱塞108可以是一体的。柱塞108的远侧端部包括拇指按压部111,以提供使用者在筒管106的轴向方向上移动柱塞108的界面。通过拉动或按压柱塞,使用者能够将流体在注射器100的近侧端部处经针102输送到注射器100中以及从其输出流体。筒管106的外表面包括可见标记112,以指示在注射器100内布置的液体的体积或剂量。例如,标记112可以与特定胰岛素浓度相关联,从而使用者可确定从对应胰岛素容器中抽出多少单位的胰岛素用于注射。就是说,标记112可以是一些胰岛素单位,这些胰岛素单位与特定胰岛素浓度相对应。标记112也可以与液体体积或任何其它适当可见显示元素相关联,该液体体积或任何其它适当可见显示元素与在注射器100中布置的液体相关联。
图2-4更详细地示出注射器100和针接口104。图2是组装好的注射器100的近侧端部的部分视图,该注射器100具有针接口104,该针接口104紧固到筒管106上。图3示出具有针安全护套114的组装好的注射器100,该针安全护套114一般布置在针接口104上,以出于保护目的而将针102隐藏。如在图3中示出的那样,针接口104包括凸缘116,该凸缘116延伸超出筒管106的圆周表面,并且与针安全护套114对接,但凸缘116的圆周表面是暴露的。
如在图2中最清楚地示出的那样,针接口104包括可见编码标记,以标识注射器100的参数。在这个例示性实施例中,凸缘116的圆周表面包括可见编码标记118,从而当安全护套114出于保护目的布置在针102上时,使用者可以容易地识别注射器100。例如,标记118可以是在凸缘116上的特定颜色(例如,黑色、红色、或蓝色),以标识与筒管106相关联的胰岛素浓度。在另一些例示性实施例中,标记118可以选择性施加到针接口104的任何部分上。例如,整个凸缘116可以包括标记118。在另一些例子中,针接口104可以包括在针接口104的任何表面上的徽标、文本、或任何其它适当区分标记。标记118可以用来指示注射器的任何适当特性,这些特性非限制性地包括针径、针长度、针类型、筒管半径、筒管体积、药剂、等等。在另一些例示性实施例中,凸缘116的圆周表面(该圆周表面具有标记118)可以与筒管106的表面在同一平面内。在另外一些实施例中,在模制筒管的正面上的圆周标记可等效于在针接口上的标记。
在一个例示性实施例中,可以通过将紫外光(UV)树脂施加到针接口104的表面上和将针接口暴露于UV光,而将标记118施加到针接口104上。在这样的实施例中,UV树脂对于UV光起反应,并且形成标记118。例如,可以使用Capex Corporation的适当UV墨水,由于其通过对于UV光的暴露而开始的聚合作用。然而,标记118可以采用任何施加可见编码标记的适当方法而形成,所述方法非限制性地例如移印、浸渍、滚筒印刷、激光处理、双注射模制、等等。
图4是立体图,更详细地示出针接口104。在针接口104的端部上的开口120构造成用以接纳筒管106。开口120包括内表面,该内表面具有凹入表面122,该凹入表面122构造成用以将针接口104紧固到筒管106上。针接口104也包括针基座124,该针基座124具有对于制造商独特的形状,以将它与竞争者的产品区分开。在图4的例子中,基座124是圆柱形的,具有与筒管106的半径大体相似的半径,并且包括圆化端部,该圆化端部渐细成与针102在同一平面内和暴露针102。如在图4中示出的那样,针102从针基座124沿轴向延伸。 如上文描述的那样,针基座124也构造成用以将安全护套114接纳和保持在大体固定位置中。
图5是在针102的轴向方向上注射器100的近侧端部的横截面图,示出开口120的凹入表面122与在筒管106的外表面上的锥形槽口128相接合。在这个例示性实施例中,当针接口104的开口120在组装期间沿轴向接纳筒管106时,锥形槽口128变得由开口120的内表面偏置。当锥形槽口128移动成与凹入表面122相邻时,锥形槽口128的偏置被解除而进入到凹入表面122中,以将针接口104与筒管106相紧固。就是说,凹入表面122和锥形槽口128形成一种锁闩机构,以将针接口104固定到筒管106上。注射器100的锁闩机构可由任何适当装置形成,并且保持紧固到筒管106上的针接口104(例如,luer锁、等等)。在另一些例子中,针接口104和圆筒106可以被模制成单个装置。
图6示出一种例示性过程130,该例示性过程130可以实施以制造注射器100。例示性过程130在步骤131处通过使用聚合物模制通用筒管和通用针接口而开始。在步骤131处,任何适当标记可以形成在筒管的表面上,以指示药剂的体积或单位。在任何标记形成在筒管上之后,在步骤132处,将塞子和柱塞组装,并且设置到筒管的远侧开口中。
在步骤133处,为针接口选择标记,该标记与在圆柱形筒管上的可见标记相关联。在另一些例示性实施例中,例示性过程130可以通过选择与针长度、针径、或任何其它注射器特性相关联的标记而开始。在步骤134处,将与选定的标记相关联的UV树脂施加到与筒管相对应的针接口上。在一个例子中,将UV树脂施加到在针接口的凸缘上的圆周表面上。在另一些例示性实施例中,可以将UV树脂施加到整个针接口上,或者可以将UV树脂的图案选择性地施加到针接口的任何表面上,如上文描述的那样。在将UV树脂施加到针接口上之后,在步骤136处,将针接口暴露于UV光源,以将树脂固化和将树脂聚合到针接口上,而在针接口上形成标记。在一个例子中,紫外光树脂 可以使针接口的凸缘是黑色的、红色的、或蓝色的。然而,可以使用任何颜色、或颜色或图案的组合(例如,带条、短划线、等等)。
在将树脂固化之后,在步骤138处由任何适当装置(例如,环氧树脂、等等)将针紧固到针接口上。例示性过程130继续,在步骤140处将针安全护套设置在针接口上。然后在步骤142处,如上文描述的那样,通过将筒管106设置到针接口的开口中,将针接口与筒管相紧固。
上述例示性实施例允许通用针接口被模制,并且与任何适当针相配合,由此对于每种筒管半径只要求一种通用针接口。另外,在针接口上的标记始终是暴露的,即使在针安全护套114就位的情况下也如此,并且提供内容物的可见指示符(例如,胰岛素浓度、药剂、等等)或注射器的其它特性(针径、针长度、筒管体积、筒管半径、等等)。因为在凸缘上的有色标记从筒管的圆周表面延伸,所以它可从任何角度容易地看到。在另一些例子中,针接口可以构造有针,该针在用UV树脂形成标记之前已经固定就位。另一个例示性实施例还可以包括用诸如胰岛素之类的药剂填充组装注射器100。在这样的例子中,在注射器中的胰岛素浓度与在注射器上的有色标记相关联。其它例示性实施例还可以包括安全注射器,该安全注射器具有以上所描述的标记。
图7示出具有针接口104的注射器100的另一个例子。在图7的例子中,使用激光标记法,将标记146选择性地设置在基座124和/或凸缘116的圆周表面上。作为例子,标记146是绕基座124的圆周的弧线,如在图7中示出的那样。可以采用任何适当的线、图案、锯齿形波、正弦线、或图形,像例如螺旋线、徽标、等等。另外,针接口104和/或筒管106可以选择性地用激光处理,以在针接口104和/或筒管106上在整个表面上形成色调。在另一些例子中,针接口104的表面可以用激光标记法按点刻图案选择性地处理,以形成着色区域。例如,在标记146与凸缘116之间的区域可以由激光选择性地处理,以在针接口104上形成带色调的区域。在这样的一个例示性实施例中,选择性激光处理可以只呈黑色,或者呈想到的其它颜色。激光标记法 影响模制塑料的表面和次表面,导致更为永久的标记,而不会对注射器的表面产生显著的热损伤。另外,激光标记法染料的量可以改变,以改变色调。
图8示出制造图7的注射器100的例示性过程150。在步骤152处,例示性过程150通过将激光标记法染料添加到聚合物(例如,聚乙烯)上而开始。一种例示性激光标记法染料是OnCapTM Fast MarkTM激光标记法添加剂,该添加剂吸收光以产生热量,由此使聚合物的表面在暴露位置处碳化。聚合物然后在步骤154处用来模制通用筒管和通用针接口。在步骤154处,任何适当标记可以形成在筒管的表面上,以指示药剂的体积或单位。在步骤156处将塞子和柱塞组装,并且设置到筒管的远侧开口中。
筒管然后在步骤158处选择性地暴露于激光源,该激光源与激光标记法染料反应,以形成标记。在步骤158处,为了防止对于筒管的塑料的显著损坏,激光源按精细间隔选择性地暴露筒管的表面的各部分,以在筒管的区域上形成色调,而在其表面上不产生显著热损坏。然后在步骤160处,将针接口选择性地暴露于激光源,以形成精细图案,而在其表面上形成色调。在例示性过程150中在步骤162处,针接口也可以选择性地暴露,以在步骤162处形成实线、图案、徽标、或其它文本(例如,与标记146类似的弧线)。
在将针接口和/或筒管用激光做标记之后,在步骤164处由任何适当装置(例如,环氧树脂、等等)将针紧固到针接口上。在步骤165处将针安全护套设置在针和针接口上。在步骤166处,如上文描述的那样,通过例如将筒管设置到针接口的开口中,并且然后施加力以使紧固件锁闩到筒管上,而将针接口与筒管相紧固。
上述例子允许选择性色调针接口具有标记和/或带色调的筒管。带色调的筒管和/或带色调的针接口可一道用来标识多个注射器特性。例如,针接口如果针长度小于6毫米(mm)则可以不具有色调,并且如果大于6mm则具有浅色调。在这样的例子中,针接口的凸缘通过以上所描述的UV固化过程可以标记有颜色,以指示另外的注射器特 性。在另一些例子中,针接口的色调、筒管的色调、在基座上的颜色标记、及在凸缘上的颜色标记可以是内容物(例如,胰岛素浓度、药剂)的可见指示符和/或注射器的其它参数(针径、针长度、筒管体积、筒管半径、等等)。可通过例如调节添加到聚合物中的激光标记法染料的量而调节标记的色调。
标记118的颜色为了使用者的方便也可以布置在另外的材料上,这些另外材料与注射器100相关联。例如,如在图9中示出的那样,胰岛素容器168可以包括帽盖170,该帽盖170具有与标记118大体相似的颜色。在这样的例子中,注射器100刺入在帽盖布置的隔膜172,以将胰岛素从胰岛素存储容器168中抽取到注射器100中。胰岛素容器168也可以具有标签174,该标签174具有显示可见指示符176,该显示可见指示符176具有与标记118大体相同的颜色,从而使用者可容易地识别正确的注射器。在注射器100上的标记118、帽盖170、及标签174的大体匹配颜色将可见指示提供给使用者(他或她正在抽取待用在注射器100中的正确胰岛素)。在又一个例示性实施例中,几个注射器100可以预先填充有胰岛素,并且在零售包装178中提供给使用者。在这样的实施例中,包装的外表面可以显示可见指示符180,该可见指示符180具有与标记118大体相同的颜色,从而使用者可容易地识别正确的注射器。
在这里公开的各个实施例中的每一个实施例中并且在另一些可选择实施例中,注射器模制元件可由聚丙烯、聚乙烯、聚对苯二甲酸乙酯、及/或生物衍生树脂制成,这些生物衍生树脂如由聚乳酸、淀粉填充的聚乙烯、或多羟基链烷酸酯。可选择地,可以使用可生物降解的树脂来形成注射器模制成分。在针接口上的针可或者在将标记设置在针接口上之前或者在其之后,与针接口相固定。如上文描述的那样,当提供给使用者时,注射器可填充有药剂(例如,胰岛素),或者可以是空的,所以使用者可从对应容器中抽取药剂。使用者可以从包装寻找注射器,该包装也标记有大体相同颜色,由此向使用者提供关于将注射的胰岛素浓度的多个通知。这保证使用者通过使用可见指示符, 如特定颜色、图案、等等,实施多个警告而将使用正确的胰岛素量。
尽管上文中已经详细描述了本实用新型的仅少量例示性实施例,但本领域的技术人员将容易地认识到,在例示性实施例中可以做出多种修改而不实质性地脱离本实用新型的新颖讲授和优点。相应地,全部这样的修改应包括在所附的权利要求书和其等效物的范围内。
Claims (12)
1.一种药剂输送装置,其特征在于,其包括:
圆柱形筒管,其具有在近侧端部处的开口以及在远侧端部处的开口;
柱塞,其布置在所述圆柱形筒管的远侧开口中,用来密封所述圆柱形筒管的远侧开口;
针接口,其位于所述圆柱形筒管的近侧开口处,用来密封所述圆柱形筒管;以及
针,其布置在所述针接口中,用来通过所述柱塞在轴向方向上的操作而注射液体,
其中,在所述针接口上的外表面包括有色标记,该有色标记在所述针接口的一部分上,该有色标记与所述药剂输送装置或其内容物的特性相对应。
2.根据权利要求1所述的药剂输送装置,其特征在于,所述有色标记选择性地形成在所述针接口的凸缘的外圆周表面上,并且其中,针接口的凸缘的具有有色标记的外圆周表面从所述圆柱形筒管的外表面沿径向延伸。
3.根据权利要求2所述的药剂输送装置,其特征在于,当将针安全护套布置在所述针上,并且与所述凸缘相接触时,在所述针接口的凸缘的具有有色标记的外圆周表面是基本可见的。
4.根据权利要求1所述的药剂输送装置,其特征在于,所述有色标记与在所述筒管的外表面上的可见标记相关联。
5.根据权利要求4所述的药剂输送装置,其特征在于,在所述筒管的外表面上的可见标记与基于胰岛素浓度的胰岛素单位相对应。
6.根据权利要求1所述的药剂输送装置,其特征在于,所述有色标记大体上与在胰岛素容器上的帽盖或标签的颜色相同,该胰岛素容器用来从其通过所述药剂输送装置的操作抽取所述胰岛素。
7.根据权利要求1所述的药剂输送装置,其特征在于,所述药剂 输送装置被包装在容器中,该容器具有外表面,其中,所述表面包括可见标记,该可见标记具有与所述有色标记大体相同的颜色。
8.根据权利要求1所述的药剂输送装置,其特征在于,所述有色标记经紫外光树脂和紫外光形成。
9.根据权利要求1所述的药剂输送装置,其特征在于,所述有色标记选择性地形成在所述针接口的基座的外表面上,其中,所述针接口的基座接合针安全护套。
10.根据权利要求1所述的药剂输送装置,其特征在于,所述筒管的表面和所述针接口的表面中的至少一个表面包括着色颜色,该着色颜色由选择性地暴露于激光而形成。
11.一种使用药剂输送装置的系统,其特征在于,其包括:
基于在药剂输送装置包装的外部上的有色标记,识别药剂输送装置,其中,所述药剂输送装置包括有色标记,该有色标记具有与在所述药剂输送装置包装的外部上的有色标记大体相同的颜色;
识别胰岛素的容器,所述胰岛素容器具有用来接纳所述药剂输送装置的帽盖,以将胰岛素连通到所述药剂输送装置中,其中,所述帽盖包括可见标记,该可见标记具有与在所述药剂输送装置上的有色标记大体相同的颜色;
用所述药剂输送装置刺入胰岛素容器的帽盖,并且通过识别在所述药剂输送装置的表面上布置的胰岛素单位,抽取规定量的胰岛素;以及
将所述胰岛素注射到患者体内。
12.根据权利要求11所述的系统,其特征在于,在所述胰岛素容器上的帽盖包括可见标记,该可见标记具有与在所述药剂输送装置上的有色标记大体相同的颜色,并且其中,在所述药剂输送装置上的有色标记与胰岛素的浓度相对应。
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- 2013-04-08 ES ES13775305T patent/ES2809517T3/es active Active
- 2013-04-08 CA CA2869624A patent/CA2869624C/en active Active
- 2013-04-08 EP EP13775305.9A patent/EP2836126B1/en active Active
- 2013-04-08 JP JP2015505832A patent/JP6581901B2/ja active Active
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2016
- 2016-02-01 US US15/012,691 patent/US9839750B2/en active Active
- 2016-02-01 US US15/012,687 patent/US10130769B2/en active Active
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
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CN109803698A (zh) * | 2016-10-13 | 2019-05-24 | 赛诺菲-安万特德国有限公司 | 药物递送装置 |
CN109803698B (zh) * | 2016-10-13 | 2022-08-19 | 赛诺菲-安万特德国有限公司 | 药物递送装置 |
US11590288B2 (en) | 2016-10-13 | 2023-02-28 | Sanofi-Aventis Deutschland Gmbh | Drug delivery device |
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WO2013155000A1 (en) | 2013-10-17 |
ES2809517T3 (es) | 2021-03-04 |
US9272099B2 (en) | 2016-03-01 |
US9839750B2 (en) | 2017-12-12 |
EP2836126A1 (en) | 2015-02-18 |
US20160144119A1 (en) | 2016-05-26 |
CA2869624A1 (en) | 2013-10-17 |
US20130267904A1 (en) | 2013-10-10 |
JP2015512747A (ja) | 2015-04-30 |
CA2869624C (en) | 2021-01-12 |
JP6581901B2 (ja) | 2019-09-25 |
EP2836126B1 (en) | 2020-05-27 |
US20160158449A1 (en) | 2016-06-09 |
EP2836126A4 (en) | 2015-08-26 |
US10130769B2 (en) | 2018-11-20 |
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