CN101095176B - 容器盖 - Google Patents
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Abstract
本发明公开了一种用于容器(12)的盖子(10)。该盖子(10)包括盖封(14)和可移动紧扣于盖封(14)的顶盖(17),其中所述顶盖(17)包括融入该顶盖17的顶表面中的装饰膜(16)。
Description
相关申请的交叉引用
本申请是2004年10月7日提交的临时申请号为60/616,809、题为“模内装饰易开键”的正式申请,在此将临时申请中的全文内容并入本申请作为参考。
技术领域
本发明涉及一种容器盖,更确切地说涉及一种药物容器盖,其包括可移动的顶盖,该顶盖含有关于容器和/或容器中物质的信息。
背景技术
通过注射器应用于病人的液体药物产品通常装在容器中,该容器用***容器颈部的塞子密封。金属盖封通常被施加在颈部的外面开口上以覆盖橡皮塞子端部。盖封通过将其绕颈部的肩卷边而固定于颈部。盖封包括位于其中心的小直径孔,促进注射器针***容器中。关于该产品的有限量的信息可压印在所述盖封上。
有时可移动顶盖连接在盖封上。该顶盖可显示有限量的产品信息,例如容器的物质、商标名称、容器中药物的用量或强度。将顶盖连接于盖封的机构特别设计为当该顶盖从盖封移去时是变形的,从而防止顶盖重置于盖封上。因此,容器上没有盖封时则明确表明已经试图使用药物或改动了容器。在专利号为5,377,853的美国专利中描述了这种顶盖。
发送给销售商的药物容器的准备过程包括步骤:(1)对空的容器杀菌,(2)用药物填充容器,(3)将橡皮塞子放置于容器的颈部,(4)将顶盖连接于盖封,(5)用盖封/顶盖组件密封容器端部,(6)对密闭容器杀菌以及(7)用与制造历史相关的容器物质和其他信息标注容器。
尤其在容器有药物的情况下,在每个容器标签上的信息与该容器中的实际物质相对应并且包括这种虑及物质制造历史的可追踪性的信息,是很重要的。因而,自从几乎该容器被填充的时刻,信息就应该理想地与每个被填充的容器关联。
然而,目前每个容器在填充时刻包括所有关于容器物质和制造该容器物质的必要信息是不可能的,因为在填充的时刻提供给容器的标签会经不起填充之后的热压步骤,并且在盖封上和/或顶盖上没有足够的空间来包含所有必要信息。而且,在每个容器被填充时被填充的容器的目的地并不知道。应用于标签的最小信息通常被法规规定,而这种法规随各个国家而变化,直到确定了容器的特定批次的目的地,才可做容器标注。直到特定批次的容器已搁置一段时间之后才可做这种决定。为了可靠确定在已搁置批次中的容器的物质,通常从每个搁置批次中取出每个批次的样品并且在标注之前解析确定样品物质。这种程序费时并且代价高。
与容器标注关联的另一问题是一伪造。这种伪造可以利用与合法商品一样的包装和标签,使得即使有经验的最终用户药剂师或开业医生也不能辨别伪造商品和合法商品。
因而,有必要提供一种用信息标识药物容器的方法,该信息提供:(1)表示容器上的标签反映容器中的实际物质的高可信度,以及(2)表示容器由标识在标签上的制造商填充的高可信度.优选地,该标识方法将虑及与容器的药物填充基本同时地实施标识,从而使得不必对在搁置批次中的容器进行取样.优选地,该标识方法还将提供不仅是与容器物质有关的存储信息,而且提供与单个容器的包装和销售有关的信息.
发明内容
简言之,本发明提供一种容器盖,该容器盖包括盖封和可移动紧扣于所述盖封的顶盖,其中所述顶盖包括融入顶表面的装饰膜。
在本发明的另一方面,本发明提供一种包括有着基本平坦的顶表面的键式部件和融入顶表面的装饰膜的容器顶盖,其中该装饰膜在其顶部包括至少一个图像。
本发明的另一方面包括一种制造容器顶盖的方法,该方法包括以下步骤:在基底顶部形成多个具有至少一个图像的排列;在基底底部连接多个存储器,使得多个排列和多个存储器对准;从基底移去每一个对准的排列和存储器以形成多个装饰膜;通过将多个装饰膜中每一个嵌入模子中并使装饰膜顶部与模子壁邻接,以形成多个顶盖;以及向所述模子中注入聚合材料而形成顶盖,其中所述装饰膜融入顶盖的顶表面中。
本发明的又一方面包括一种建立药物容器物质可追踪性的方法,该方法包括:在存储器中存储不可变更的字符串,该字符串与存储器唯一关联;以及与用物质填充容器基本同时地将存储器连接于容器,其中所述被填充的容器其后经受杀菌,并且其中在所述容器经受杀菌之后,所述存储器保持全功能。
附图说明
结合附图将更好地理解上述发明内容和本发明的以下详细描述。出于说明本发明的目的,附图中示出了目前优选的实施例。然而应该理解,本发明不限于所示的特定装置和手段。图中:
图1是一盖子优选实施例的剖视图,该盖子包括顶盖和与容器相连的盖封;
图2A是在紧扣于图1中所示的盖封之前的图1中所示顶盖的优选实施例的剖视图;
图2B是图1中所示顶盖的可选实施例的剖视图;
图3是图1中所示盖封的平面图;
图4是装饰膜优选实施例的顶部的平面图;
图5是所述装饰膜优选实施例底部的平面图;以及
图6是一基底的优选实施例的平面图,在该基底上形成有多个排列的图像。
具体实施方式
参照附图,其中几幅图中相同的附图标记用以指相同的部件,并且使用不定冠词“a”可以指部件数量为一个或多个,图1示出了与容器12相连的盖子10的优选实施例。盖子10最好的效用是用于封闭用塞子14密封的并且含有药物的玻璃、瓶式容器12,但是其同样适于封闭其他类型的容器12,例如由聚合材料制成的、包括弹性袋的容器,该弹性袋装有要求必需在容器12的开口处保持卫生条件的材料,和/或要求容器12内的物质的可追踪性/鉴定,和/或要求提供明确迹象表示盖子10已经打开的容器。
盖子10包括带有可移动连接的顶盖17的盖封11。该盖封11具有用于连接于容器12的外侧下垂边42。在盖封11的肩状部46的内终边上形成凹口边44。优选地,具有中心定位的孔30的环形中心部48通过多个间隔的桥50(图3)与凹口边44相连。桥50优选沿径向变细变窄,以便当将环形中心部48从凹口边44移开时,(见下文)桥50也从凹口边44移开。盖封11与专利号为5,152,413、题为“用于药用的和类似的容器的金属顶盖”的美国专利中所描述的盖子基本相同,在此将该申请中的全文内容并入本申请作为参考。可选地,环形中心部48可与凹口边44结合,并且绕环形中心部周边设置圆形划线,以便促进环形中心部48从凹口边44移开。
顶盖17(图2A和2B)是具有基本平坦的顶面15的键式部件,由聚合材料成形或模制而成,例如聚丙烯或其他类似的塑料。环形下垂环形式(图2A)的突部19从顶盖17的底面15′垂下。可选地,如图2B所示,该突部可以是实心柱。该突部19的大小设计为适于安装在盖封11的中心孔30中。将顶盖17装配于盖封11时,(图1)突部19用桩支撑,以便突部19延伸至环形中心部48上,从而使顶盖17紧扣于盖封11。通过抵着顶盖17边缘向上挤压而可从盖封11移开顶盖17。当顶盖被移开时,将环形中心部48保持于盖封11的间隔的桥50(或划线)破裂。因此,当顶盖17从盖封11移开时环形中心部48归于顶盖17。这防止了一旦顶盖17被移开后再将其重置于盖封11之上的情况。
优选地,顶盖17包括融合在其顶表面15以便装饰膜16的顶部可视的装饰膜16(图4和5)。优选地,装饰膜16利用2003年4月8日授权的专利号为6,544,634(′634)、题为“图像融合”的美国专利中所描述的方法之一融合在顶表面15中,在此将该美国专利全文内容并入本申请作为参考。然而,也可使用其他方法,将装饰膜16融入顶盖17中。
在优选实施例中,装饰膜16由基底34构成。优选地,基底34是具有不大于10密耳(mil)的厚度的可印刷页,并且是一种可经受得住曲折的喷射模塑环境、具有各种热塑性和热固性材料而不可模压的、并且当融入顶盖17中时可经受得住压热作用的可印刷页。一种该类材料是二氧化硅填充的多微孔层材料。优选地,基底34是如在′634号专利中所描述的PPG工业MIST十密耳厚的材料。然而,也可使用其他沉淀的二氧化硅填充的多微孔层材料。
在优选实施例中,装饰膜16通过在基底34(图6)的顶部24印刷一个或多个图像18的多个排列40并且通过在基底34的底部24′连接多个存储器(未示出)形成,使得排列40中的每一个与相应的存储器28对准排列在基底34上。优选地,存储器28通过粘合剂连接于基底34。然而,设备28的部分可印刷在基底34上。尽管优选每一装饰膜16包括一个或多个图像18以及存储器28,该装饰膜16也可仅包括有图像18或仅包括有存储器28,并且仍在本发明实质和范围内。
优选地,装饰膜16中的每一个通过标准冲压方法从基底34上移去每一对准的排列40及其相应的存储器28而形成。优选地,而后每一装饰膜16被嵌入模子中,且装饰膜16的顶部24与该模子的壁相邻接。而后聚合材料被注入模中以形成顶盖17。从而,由于装饰膜16完全嵌入(即融入)顶盖17的聚合材料中,所以该装饰膜16在受到热压、如伽马射线或电子束射线的辐射、环氧乙烷气体或深冻结之后还能够保持图像18的易辨性。在一实施例中,装饰膜16在将聚合材料注入模子过程中通过静电荷被固持倚靠着模子壁。
存储器28可以是能够永久存储数据的任何类型的设备,其可以无线读取,并且当整合在盖子10中时受到热压或深冻结之后能够有完整功能性.这种设备可以包括:例如,磁致伸缩的、磁性的、以及无源谐振标签.在优选实施例中,存储器28是无线射频识别装置(RFID)集成电路28和关联天线26(图5).优选地,天线26是平面天线.优选地,RFID集成电路28和天线26利用高温环氧粘合剂连接在装饰膜16的基底34上.然而,也可使用其他类型的粘合剂或密封剂以及其他粘结方法,例如焊接.可选地,天线26可印刷到基底34上.
在优选实施例中,RFID集成电路28包括96位存储器,其中一部分是只读存储器。尽管优选RFID包括96位存储器,但RFID也可包括如3000位或更多位的存储器。优选地,每一RFID 28的只读部分被用于存储独属于每一RFID集成电路28(即每一顶盖17)的字符串。该特有字符串不可由普通方法改变。因此,当顶盖17连接于容器12时,特有序列变得与容器12连接。其他信息可保存在所述存储器的不用于存储特有字符串的部分。在模制顶盖17之前或之后并且在沿包装和产品供应链的位置,可添加其他信息并且可无线读取所有储存信息。RFID 28中储存的信息可包括但不限于:定制序列号(custom serial number)、隐秘或鉴定标识符(covert or forensicidentifier)、特定包装号(specific package number)、生产日期、生产地、产品代码、客户代码、产品填充(fill)日期、产品有效期、生产/填充地、货运地(ship to location)、校验收据、校验剂量日期(dispensingdate)、校验客户、校验剂量依从性以及校验产品综合性。可通过查询装置直接了解该信息或可连接于数据库获得说明。
优选地,每个图像排列40中的图像18按层次、彼此叠加形成。然而,每一图像排列40可以以单层图像18形成或者可以是层状、并排的图像18的联合。图像18可利用平版印刷术或类似工艺形成,例如丝网印刷、苯胺印刷、凹版印刷、高分辨喷墨印刷以及彩色或黑白激光印刷,并且图像18可具有多种色彩。被选择的图像18还可由磁墨形成并且电可读。
当在具有基本日光光谱的光线下观看时,单个图像18对于肉眼可以是可视或不可视的。在日光光谱下图像18对肉眼为不可视时,通过用具有预定波长的射线例如紫外线照射图像18,该图像成为可视。还可用具有其他波长的射线,例如红外射线或具有无线电波长的射线以及电磁频谱的x射线部分。
优选地,膜16包括至少一个在用具有基本日光光谱的光照射时是可视的图像,以及至少一个在用具有基本日光光谱的光照射时是不可视的图像。在图4中示出了装饰膜16的一个实例,该装饰膜16具有有着可视图像18a的顶层以及有着不可视图像18b的在第一层之下的第二层。可视图像18a由包括可视识别标记和窗口18c的不透明区组成,该窗口18c对可见物和紫外线光是透明的,并且通过用紫外线光照射该窗口18c,透过窗口可看见不可视图像18b。本领域技术人员用该理解,该膜16,具有可视和不可视图像18的层可以为任何数量以及任何顺序。
图像18,随便可视或不可视的,可以包括可印刷的任何类型的图像,包括可为黑的、白的或透明的纯色、文字的、图形的、相片的以及生物特征的图像。尤其,具有大量难以复制的近乎随机的细节的相片或生物特征型图像,如风景、指纹、虹膜扫描等,可印刷在装饰膜16上而产生为了防伪或其他目的的隐秘信息。
顶盖17尤其适于提供高可信度,该可信度表示容器12上的标签反映容器12中的实际物质,以及容器12通过建立容器12中物质的追踪性由标识在容器12的标签上的制造商填充,通过如下方式建立容器中物质可追踪性:在存储器28中存储不可变更的字符串,该字符串与存储器28唯一关联时,填充容器12,并且与填充容器12基本同时地将该存储器28连接于容器12.因此在容器12被填充的相同时间段中,通过将具有唯一字符串以及其他信息的存储器18连至容器12,从而在存储器18中不正确记载容器12中物质及物质的来源的可能性被最小化.而且,通过读取存储器28中的字符串和/或其他数据以及顶盖17的标记,可在确定容器12最终目的地的时候准备好标签,而不必解析确定容器12中的物质.
已用盖子10封闭的容器可通过热压、电子束射线、伽玛射线以及环氧乙烷气体进行杀菌,并且在冷冻温度下长期储存。在优选实施例中,顶盖17和盖封11所选择的材料对通过热压和伽玛射线对容器12中物质的杀菌有抵抗力。而且,在经受121摄氏度下二十分钟的热压,并且经受负80摄氏度的温度至少一个月的时期之后,图像18中每一个都保持易读并且存储器保持全功能。优选地,在经受121摄氏度下至少六十分钟的热压后,图像18中每一个都保持易读并且存储器保持全功能。另外,当经受伽玛射线和电子束射线的杀菌级别时图像18保持易读。这种杀菌级别通常在大约25kgray范围内。
本领域技术人员应该理解,本发明适于存储信息,该信息提供:(1)表示容器12上的标签反映容器12中的实际物质的高可信度,以及(2)表示容器12由标识在标签上的制造商填充的高可信度。该标识容器12的方法虑及与填充容器12基本同时地实施标识,从而使得不必对在搁置批次中的容器12进行取样来鉴别物质。要求保护的顶盖还提供不仅是与容器12物质有关的存储信息,而且提供与单个容器12的包装和销售有关的存储信息。而且,从不经意的观察者来看,所选择的信息是隐秘的并且可能难以复制,因而提供了一种防伪措施。
本领域技术人员应该理解可对上述实施例做改变而不脱离其宽泛的发明概念。从而,应该理解本发明不限于所公开的特定实施例,而意在覆盖如所附权利要求所限定的在本发明的实质和范围内的修改。
Claims (32)
1.一种容器顶盖,其包括:
具有基本平坦的顶表面的键式部件;以及
融入所述顶表面的装饰膜,所述装饰膜包括:
位于所述装饰膜顶部第一层中的至少一个第一图像;以及
位于所述第一层下面的一层中的第二图像,所述第二图像仅在用具有预定波长的射线照射时才可视。
2.根据权利要求1所述的顶盖,其特征在于,所述装饰膜包括二氧化硅填充的多微孔基底。
3.根据权利要求1所述的顶盖,其特征在于,当用具有基本日光光谱的光线照射时,所述至少一个第一图像对于肉眼可视。
4.根据权利要求1所述的顶盖,其特征在于,当用具有基本日光光谱的光线照射时,所述至少一个第一图像对于肉眼不可视。
5.根据权利要求4所述的顶盖,其特征在于,通过用具有预定波长的射线照射至少一个不可视的所述第二图像,所述第二图像对于人成为可视。
6.根据权利要求3所述的顶盖,其特征在于,通过从由平版印刷术、凹版印刷术、苯胺印刷术组成的组中选择的工艺,将所述第一和第二图像中的至少一个图像固定于所述装饰膜顶部。
7.根据权利要求1所述的顶盖,其特征在于,所述第一层的一部分对于所选波长范围的射线是透明的。
8.根据权利要求1所述的顶盖,其特征在于,所述膜包括至少一个在用具有基本日光光谱的光照射时是可视的图像,以及至少一个在用具有基本日光光谱的光照射时是不可视的图像。
9.根据权利要求1所述的顶盖,其特征在于,所述第一和第二图像中的至少一个图像包括隐秘信息。
10.根据权利要求1所述的顶盖,还包括连接于所述膜底部的存储器。
11.根据权利要求10所述的顶盖,其特征在于,存储在所述存储器中的信息可无线读取。
12.根据权利要求11所述的顶盖,其特征在于,所述存储器是无线射频识别装置。
13.根据权利要求11所述的顶盖,还包括连接于所述膜的底部以及连接于所述存储器的天线。
14.根据权利要求13所述的顶盖,其特征在于,所述存储器和天线通过粘结连接于所述膜。
15.根据权利要求13所述的顶盖,其特征在于,所述天线印刷在所述装饰膜上。
16.根据权利要求10所述的顶盖,其特征在于,所述存储器包括独属于所述存储器的已存储字符序列,所述字符序列能够被无线读取并且不能被更改。
17.根据权利要求10所述的顶盖,其特征在于,在经受121摄氏度的温度至少二十分钟之后,连接于所述顶盖的所述存储器保持用以读取和写入的全功能。
18.根据权利要求10所述的顶盖,其特征在于,在经受负80摄氏度的温度至少一个月之后,连接于所述顶盖的所述存储器保持用以读取和写入的全功能。
19.根据权利要求1所述的顶盖,其特征在于,使所述顶盖经受121摄氏度的温度至少二十分钟之后,所述至少一个第一图像保持易读。
20.根据权利要求1所述的顶盖,其特征在于,在经受负80摄氏度的温度至少一个月之后,所述至少一个第一图像保持可读。
21.根据权利要求1所述的顶盖,其特征在于,在经受从含有伽马射线、电子束射线和环氧乙烷气体的组中选择的杀菌方法之后,所述至少一个第一图像保持可读。
22.一种制造药物容器顶盖的方法,其包括以下步骤:
在基底顶部形成多个具有至少一个图像的排列;
在所述基底底部连接多个存储器,使得所述多个排列和多个存储器对准;
从所述基底移去每一个对准的排列和存储器以形成多个装饰膜;
通过将所述多个装饰膜中的每一个嵌入模子中并使装饰膜顶部与模子壁邻接,以形成多个顶盖;以及
向所述模子中注入聚合材料以形成所述顶盖,其中所述装饰膜融入所述顶盖的顶表面中。
23.根据权利要求22所述的方法,其特征在于,在所述将聚合材料注入模子的步骤中,所述装饰膜通过静电荷固持于所述模子壁。
24.一种容器盖,其包括:
盖封,所述盖封具有环形中心部;以及
可移动紧扣于所述盖封的顶盖,所述顶盖包括与所述环形中心部结合的下垂突部,当所述顶盖从所述盖封移去时,所述环形中心部归于所述顶盖。
25.根据权利要求24所述的盖子,其特征在于,所述顶盖包括融合在顶表面的装饰膜,所述装饰膜包括至少一个图像。
26.根据权利要求25所述的盖子,其特征在于,所述至少一个图像包括:在用具有基本日光光谱的光照射所述顶盖时对于人是可视的图像,以及在用具有基本日光光谱的光照射所述顶盖时对于人是不可视的但用预定波长的射线照射所述顶盖时是可视的图像。
27.根据权利要求25所述的盖子,其特征在于,所述装饰膜在顶部包括至少一个图像并且在底部包括电子存储器。
28.根据权利要求27所述的盖子,其特征在于,所述电子存储器是无线射频识别装置。
29.根据权利要求24所述的盖子,其特征在于,所述环形中心部脆弱连接于所述盖封。
30.一种建立容器物质可追踪性的方法,所述方法包括以下步骤:
在能够被无线读取的存储器中存储不可变更的字符串,所述字符串与所述存储器唯一关联;以及
与用物质填充所述容器基本同时地将所述存储器连接于所述容器,其中所述被填充的容器其后经受杀菌,并且其中在所述容器经受杀菌之后,所述存储器保持全功能。
31.根据权利要求30所述的方法,其特征在于,所述存储器是无线射频识别装置。
32.根据权利要求30所述的方法,还包括以下步骤:当备好提供给所述容器的纸标签时,读取用以识别所述容器物质的所述字符串。
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- 2005-10-06 EP EP05806795A patent/EP1797542B1/en active Active
- 2005-10-06 JP JP2007535789A patent/JP2008515732A/ja active Pending
- 2005-10-06 CN CN200580034505.9A patent/CN101095176B/zh active Active
- 2005-10-06 BR BRPI0516567-9A patent/BRPI0516567A/pt not_active Application Discontinuation
- 2005-10-06 AU AU2005294309A patent/AU2005294309A1/en not_active Abandoned
- 2005-10-06 AT AT05806795T patent/ATE555460T1/de active
- 2005-10-06 US US11/244,642 patent/US7394383B2/en active Active
- 2005-10-06 WO PCT/US2005/035902 patent/WO2006041965A2/en active Search and Examination
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2007
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2008
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Also Published As
Publication number | Publication date |
---|---|
JP2008515732A (ja) | 2008-05-15 |
CN101095176A (zh) | 2007-12-26 |
WO2006041965A2 (en) | 2006-04-20 |
US20060092013A1 (en) | 2006-05-04 |
MX2007004193A (es) | 2007-10-16 |
IL182291A0 (en) | 2007-07-24 |
CA2582382A1 (en) | 2006-04-20 |
AU2005294309A1 (en) | 2006-04-20 |
US7394383B2 (en) | 2008-07-01 |
EP1797542A4 (en) | 2010-11-24 |
ATE555460T1 (de) | 2012-05-15 |
HK1107606A1 (en) | 2008-04-11 |
WO2006041965A3 (en) | 2007-05-31 |
EP1797542B1 (en) | 2012-04-25 |
EP1797542A2 (en) | 2007-06-20 |
BRPI0516567A (pt) | 2008-09-09 |
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