CN112972833B - 注射器针帽脱离器 - Google Patents
注射器针帽脱离器 Download PDFInfo
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- CN112972833B CN112972833B CN202110470250.1A CN202110470250A CN112972833B CN 112972833 B CN112972833 B CN 112972833B CN 202110470250 A CN202110470250 A CN 202110470250A CN 112972833 B CN112972833 B CN 112972833B
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- needle cap
- needle
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- hollow body
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Abstract
公开了一种盖体,用于具有针、针帽和针帽脱离器的注射器,该帽脱离器是用于针帽和用户手柄的联接器,用户手柄具有与联接器相对的突出元件,突出元件具有短尺寸和长尺寸,该盖体包括:覆盖注射器的外部表面的至少一个粘合层;覆盖粘合层的至少一个衬垫层,延伸超过表面的延伸部;穿过粘合层和衬垫层的第一孔,第一孔与表面中的开口对准,所述第一孔的尺寸和形状适于使所述联接器穿过其中;以及穿过所述延伸部的第二细长孔,所述第二细长孔具有比所述突出元件的短尺寸更长并且比所述突出元件的长尺寸短的长度。
Description
本申请是申请日为2016年10月10日、申请号为201680072023.0、发明名称为“注射器针帽脱离器”的发明申请的分案申请。
技术领域和背景技术
本发明在一些实施例中涉及一种针帽脱离器,更具体地但非排他地涉及分叉式(bifurcated)针帽脱离器。
申请号为US2012/0238961的美国专利公开了“一种可与自动注射装置的远端帽可靠地接合并且具有联接到该装置的注射器的一个或多个针护罩的针护罩脱离器。当使用者移除远端帽时,针护罩脱离器从注射器可靠地移除针护罩(例如,软的针护罩和刚性针护罩),由此暴露注射针以进行注射。在示例性组装方法中,在将注射器和针护罩脱离器组件插入到装置的壳体中之前,将针护罩脱离器接合到联接到注射器的针护罩。该示例性组装方法允许在装置的壳体外部进行目视检查,以确保在将注射器和针护罩脱离器组件插入壳体中之前,针护罩脱离器被正确且可靠地接合到针护罩”。
专利号为6,843,782的美国专利公开了“一种药物输送装置,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物从注射器排出的装置。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。输送针与注射器连通。针具有成角度的弯曲,其引导针的尖端基本上垂直于皮肤接触表面。在使用中,针的尖端适于穿透对象的皮肤”。
公开号为WO 2015/048791的国际专利申请公开了“一种制备使用的复合装置的方法。该装置可包括密封部件和活动的外表面。外表面可以由表面盖体保护。制备该装置可包括通过移除表面盖体而使活动的外表面激活、以及通过开启密封部件而将密封部件的内部部分暴露到该装置的外部、同步激活,且所述开启使用连接到表面盖体和密封部件的联接器”。
发明内容
例1.
一种用于移除针帽的装置,所述针帽用于防护注射器系统的针,所述装置包括:细长的中空主体,其具有尺寸和形状设置成至少部分地包络针帽的远端;以及至少一个卡扣,所述卡扣联接到所述细长主体的至少一个相应元件上;所述细长主体具有闭合构造和打开构造,其中所述闭合构造由所述至少一个卡扣限定,所述至少一个卡扣限定比所述针帽的顶部槛的宽度小的宽度,并且所述打开构造由所述至少一个卡扣限定,所述至少一个卡扣具有足够宽的宽度以至少适合所述顶部门槛的宽度;其中处于所述闭合构造的所述中空主体的形状设置为保持所述至少一个卡扣悬伸在所述针帽的顶部槛上,其中所述空心主体包围所述针帽的下部部分。
例2.
根据例1的装置,其中所述至少一个卡扣朝向所述针帽的中心轴线弯曲,相对于所述轴线成角度。
例3.
根据例1-2中任一项的装置,包括至少两个卡扣,所述至少两个卡扣联接到至少两个相应元件,所述至少两个卡扣是至少两个弹性臂,所述至少两个弹性臂具有打开构造,所述打开构造通过从所述针帽的中心轴线弹性偏离而限定,以及其中一旦所述至少两个卡扣被推到所述针帽的顶部槛以外,所述弹性臂返回到它们的闭合构造并且所述至少两个卡扣悬伸于所述针帽的顶部槛上。
例4.
根据例3的装置,其中所述至少两个弹性臂中的每一个被限定为两个狭缝之间的表面,所述两个狭缝从所述细长中空主体的远端延伸。
例5.
根据例4的装置,其中所述狭缝延伸至具有所述细长中空主体的长度的约20%到约60%之间的范围的长度。
例6.
根据例4-5中任一项的装置,其中所述两个狭缝中的每一个具有约0.5mm至约1.5mm范围内的宽度。
例7.
根据例4-6中任一项的装置,还包括设置在所述两个狭缝之间的表面中的至少一个中间纵向狭缝。
例8.
根据例3-7中任一项的装置,其中所述至少两个臂包围所述细长中空主体的周长的不超过约40%。
例9.
根据例8的装置,其中所述至少两个臂围绕所述细长中空主体的圆周对称地定位。
例10.
根据例1-9中任一项的装置,其中所述细长主体配置成使用约50g和约200g范围间的力推到所述针帽上。
例11.
根据例1-10中任一项的装置,其中所述细长主体还包括至少两个引导件,所述至少两个引导件沿着其内表面并且沿着所述细长主体的纵向轴线定向,所述至少两个引导件的尺寸和形状设置成容纳定位在所述针帽的外表面上的互补元件。
例12.
根据例1-11中任一项的装置,还包括连接器,所述连接器的尺寸和形状被设置成与所述主体的近侧部分配合,所述连接器包括具有突出元件的用户手柄。
例13.
根据例12的装置,其中所述细长主体还包括至少一个互锁元件,所述至少一个互锁元件与位于所述连接器中的互锁构件互补,从而抑制所述细长主体相对于所述连接器的横向移动。
例14.
一种用于药物输送的系统,包括:药筒,所述药筒容纳药物并与针流体连通,所述针由针帽包围;壳体,所述壳体用于容纳所述药筒并具有用于允许进入所述针帽及其相关针的孔口;以及针帽脱离器装置,其包括:至少两个弹性臂,所述至少两个弹性臂联接以限定大于所述针帽的所述顶部槛的宽度的外侧的无应力宽度,所述弹性臂包围所述针帽的至少一部分,其中,可以通过所述孔口进入所述弹性臂的近端;以及至少两个卡扣,每个卡扣联接到所述至少两个弹性臂中的每一个的远端,所述卡扣限定了小于所述针帽的所述顶部槛的宽度的无应力宽度;其中所述至少两个卡扣悬伸于所述针帽的所述顶部槛上,并且当所述弹性臂的所述近端被拉动时,所述卡扣使所述针帽与所述针帽脱离器装置一起拉动。
例15.
根据例14的系统,其中所述至少两个卡扣中的每一个包括朝向所述针帽的中心轴线弯曲并且朝向所述针帽的顶表面成角度的两个钩。
例16.
根据例15的系统,其中所述钩围绕所述针帽的所述顶部槛的中心轴线对称地布置。
例17.
根据例15-16中任一项的系统,其中所述针帽脱离器装置包括所述至少两个臂中的两个,并且其中所述两个臂中的每一个包括所述钩中的两个。
例18.
根据例14-17中任一项的系统,还包括具有保护衬垫的粘合层,所述粘合层连接到所述壳体,其中所述保护衬垫延伸超出所述壳体的表面并且位于所述帽脱离器主体和所述连接器之间。
例19.
根据例18的系统,其中当所述针帽脱离器被线性拉动时,所述保护衬垫从所述壳体上被剥离。
例20.
根据例14-19中任一项的系统,其中,拉动所述帽脱离器主体和所述包封的针帽至多需要不超过1kg的力。
例21.
一种将针帽脱离器组装到针帽上的方法,包括:将所述针帽脱离器主体的纵向轴线与所述针帽的纵向轴线对准共线;将所述帽脱离器主体的远端沿着所述针帽的顶部的方向插入,同时使所述帽脱离器主体的至少两个弹性元件沿远离所述针帽的中心轴线的方向偏离,所述偏离通过联接到所述弹性构件的远端并限定比所述针帽的周界更小的周界的多个钩来提供;其中提供所述插入直到所述多个钩延伸超过所述针帽的所述顶部部分并且朝向所述针帽的所述中心轴线向内卡合,从而悬伸于所述针帽的所述顶部部分,导致所述弹性元件从所述偏离朝向所述针帽的中心轴线卡合。
例22.
根据例21的方法,其中所述针帽包含在注射器系统内,并且所述方法还包括将所述针帽脱离器插过所述注射器系统中的可进入所述针帽的孔口。
例23.
根据例21-22中任一项的方法,还包括将所述针帽脱离器主体的近侧部分与具有用户手柄的连接器互锁。
例24.
根据例16的方法,还包括将所述帽脱离器主体与电池隔离器相关联。
例25.
一种用于注射器的盖体,所述注射器具有针、针帽和针帽脱离器,所述针帽脱离器具有用于针帽和用户手柄的联接器,所述用户手柄具有与所述联接器相对的突出元件,所述突出元件具有短尺寸和长尺寸,所述盖体包括:覆盖所述注射器的外部表面的至少一个粘合层;覆盖所述粘合层的至少一个衬垫层,延伸超过表面的延伸部;穿过所述粘合层和所述衬垫层的第一孔,所述第一孔与表面中的开口对准,所述第一孔的尺寸和形状适于使所述联接器穿过其中;以及穿过所述延伸部的第二细长孔,所述第二细长孔具有比所述突出元件的短尺寸更长并且比所述突出元件的长尺寸更短的长度。
例26.
根据例25的盖体,其中所述延伸部和所述衬垫由单个一体材料片制成。
例27
根据例25的盖体,其中所述第二细长孔的宽度小于从所述突出元件沿其长尺寸延伸的肩部。
例28
根据例27的盖体,其中所述延伸部包括弹性材料,所述弹性材料使足够拉伸以越过所述肩部以及悬伸到所述肩部的顶部槛上。
例29.
根据例28的盖体,其中所述弹性材料位于所述第二细长孔的圆周的至少一部分中。
例30.
根据例25-29中任一项的盖体,还包括围绕所述第二细长孔的圆周的至少一部分的刚性层。
例31.
根据例25-30中任一项的盖体,其中所述第一孔具有与所述针帽脱离器的圆周形状相匹配的圆周形状。
例32.
根据例31的盖体,其中所述第一孔的圆周形状的宽度比所述针帽脱离器的圆周形状的宽度宽不超过约1mm。
例33.
根据例25-32中任一项的盖体,还包括至少一个间隔支撑层(intermittentsupporting layer),所述至少一个间隔支撑层附接到所述至少一个衬垫层,所述间歇支撑层在所述盖体的区域上不连续;
例34.
一种组装自动注射器装置的方法,所述自动注射器装置具有内部容积和基座,所述基座位于所述内部容积和由所述基座限定的外表面之间,所述基座具有开口,所述方法包括:提供盖体,所述盖体具有第一孔,所述第一孔与所述基座中的所述开口对准,所述盖体具有延伸部,所述延伸部延伸超过所述基座的外表面并具有第二孔;使针帽脱离器的远侧部分穿过所述第一孔和开口;将所述远侧部分联接到定位在所述内部容积中的针帽;将所述延伸部弯曲在设置在所述针帽脱离器的近端中的突出元件上;所述突出元件具有长尺寸和短尺寸;使所述盖体的第二孔定向成面向所述突出手柄的短尺寸并将所述盖体旋转到所述突出元件上直到所述第二孔定向为面向所述长尺寸。
例35.
根据例34的方法,还包括:将具有带帽针的药筒互锁在所述基座的内部部分中,所述药筒中心轴线垂直于所述盖体,并且所述带帽针与所述盖体的所述第一孔和所述基座的所述开口居中对齐。
例36.
根据例34至35中任一项的方法,其中所述盖体将远离所述外表面的线性运动转换成所述盖体上的剥离力。
例37.
根据例34-36中任一项的方法,还包括沿着所述长尺寸在距所述长尺寸的中心轴线的偏移方向上滑动所述第二孔。
例38.
根据例34-37中任一项的方法,还包括通过将所述第二孔限制在所述突出元件的加宽部分上来稳定所述盖体在所述突出元件上的延伸。
例39.
根据例38的方法,其中所述限制还包括使所述第二孔穿过所述加宽部分进入狭窄部分并在所述加宽部分上方悬伸于所述第二孔径的边缘上。
例40.
根据例34-39中任一项的方法,还包括旋转所述用户手柄,使得所述长尺寸不与所述第二孔的长度对齐。
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。
本发明的实施例的方法和/或系统的实现可以涉及手动地、自动地或者其组合地执行或者完成选择的任务。此外,根据本发明的方法和/或系统的实施例的实际仪器和设备,可以通过硬件、通过软件或通过固件或通过使用操作系统的组合来实现几个选择的任务。
例如,根据本发明实施例的用于执行所选任务的硬件可以被实现为芯片或电路。作为软件,根据本发明实施例的选定任务可以被实现为由计算机使用任何合适的操作系统执行的多个软件指令。在本发明的示例性实施例中,根据本文描述的方法和/或系统的示例性实施例的一个或多个任务由诸如用于执行多个指令的计算平台的数据处理器执行。可选地,数据处理器包括用于存储指令和/或数据的易失性存储器和/或用于存储指令和/或数据的非易失性存储器,例如磁性硬盘和/或可移动介质。可选地,也提供网络连接。还可选地提供显示器和/或用户输入设备,例如键盘或鼠标。
附图的几个视图的简要说明
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,利用附图所作的描述对于对于本领域技术人员而言可以显而易见地得出如何实施本发明的实施例。
在附图中:
图1A-E示意性地示出了根据本发明的一些实施例的用于移除具有分叉主体的针帽的示例性装置,其中图1A示出了透视图,图1B示出了前视图,图1C示出了侧视图,图1D示出了俯视图,而图1E示出了透视俯视图;
图2A-C示意性地示出了根据本发明的一些实施例的注射器装置中的帽脱离器的示例性用途,其中,图2A示出了用于自动注射器组件中的装置的示例,图2B示出了设置在图2A的注射器中的内部药筒和针组件,并且图2C示出了用于自动注射器组件中的装置的另一示例注射器;
图3A-G示意性地示出了根据本发明的一些实施例将注射器装置的粘合衬垫示例性结合到帽脱离器中,其中图3A示出了透视侧视图,图3B示出了侧视图,图3C示出组装到药筒上的帽脱离器的横截面侧视图,图3D示出具有装置盖体的注射器的透视图,图3E示出具有装置盖体的注射器的前视图,图3F示出了根据本发明的一些实施例的装置盖体的透视图,并且图3G示出了装置盖体层的分解图;
图4A-I示意性地示出了根据本发明的一些实施例的示例性针帽脱离器分叉盖和其具有针帽的组件,其中图4A示出了透视图,图4B示出了前视图,图4C示出了侧视图,图4D示出了俯视图,图4E示出了针帽脱离器实施例的仰视图,并且图4E示出了第二针帽脱离器盖实施例,其示出为组装在图4F的药筒上的帽脱离器装置的一部分,以及图4G示出了被推到针帽上的针帽脱离器装置的前视横截面图,并且图4H示出了组装后的装置和针帽的横截面图,以及图4I示出了与帽脱离器组装在一起的针帽的顶部的局部透视近视图;
图5A-E示意性地示出了根据本发明的一些实施例的具有手柄的示例性帽脱离器连接器,其中图5A示出了透视图,图5B示出了横截面图,图5C示出了俯视图,图5D示出了前视图,图5E示出了侧视图;
图6是示出根据本发明的一些实施例的用于将针帽脱离器组装到针帽上的示例性过程的流程图;
图7是示出根据本发明的一些实施例的具有粘合衬垫的针帽脱离器组件的示例性组装的流程图;
图8是示出根据本发明的一些实施例的组装自动注射器装置的示例性过程的流程图;
图9A-B示意性地示出了根据本发明的一些实施例的示例性多部件帽脱离器,其中图9A示出了处于打开构造的多部件帽脱离器,而图9B示出了处于紧闭构造的多部件帽脱离器;
图10是示出根据本发明的一些实施例的将多部件帽脱离器组装到针帽上的过程的流程图;以及
图11A-C示出了根据本发明的一些实施例的单臂针帽脱离器,其中图11A示出了该装置的透视图,图11B示出了该装置的横截面图,图11C示出了该装置的俯视图。
具体实施方式
本发明在一些实施例中涉及一种针帽脱离器,更具体地但非排他地涉及分叉式(bifurcated)针帽脱离器。
概述
本发明的几个实施例的一个方面涉及一种针帽脱离器,该针帽脱离器被构造成沿一个方向滑动并沿相反方向夹紧。在一些实施例中,针帽脱离器包括具有纵向轴线的盖主体,该盖主体的特征在于具有构造成被推到和/或容纳和/或包围针帽的远端和构造成由使用者拉动的近端。可选地,该主体是圆柱形的。或者,该主体包括圆锥形部分。可选地或另外地,该主体包括至少两个纵向臂,至少两个纵向臂至少部分地联接以限定管状结构,所述管状结构可选地具有大于针帽直径的直径。
在一些实施例中,盖主体包括至少两个钩,可选地联接到其远端。在一些实施例中,所述钩设置在纵向臂的远侧部分处。可选地,所述钩限定小于针帽直径的直径。在一些实施例中,一旦盖主体被推到针帽上,所述钩就偏离针帽的中心轴线,以允许其限定的直径配合在针帽的较大直径上。在一些实施例中,钩的偏转由弹性元件提供,可选地,弹性元件包括至少两个纵向臂。
在一些实施例中,所述至少两个纵向臂由盖主体中的分叉部分限定。可选地,分叉部分构造成分配推力,可能地使得能够将针帽脱离器组装到针帽上而不会在针帽上施加太大的力,例如施加不超过100g的力,或者施加不超过150g的力,或施加不超过200g的力,或施加不超过250g的力。可选地或另外地,分叉部分构造成分配拉力,使得潜在地用针帽脱离器移除针帽基本上保持轴向方向。在一些实施例中,为了拉动针帽,施加不超过0.5Kg的力。或者,施加不超过0.7公斤的力。或者,施加不超过0.9Kg的力。或者,施加不超过1Kg的力。或者,施加不超过1.2Kg的力。或者,施加不超过1.5Kg的力。在一些实施例中,帽脱离器盖主体具有一体的近端和分叉远端。
在一些实施例中,帽脱离器的分叉端包括4个将分叉端分成4个纵向臂的狭缝。可选地或另外地,帽脱离器的分叉端包括5个、或6个、或7个或8个狭缝。可替代地或另外地,帽脱离器的分叉端包括2个或3个狭缝。可选地,狭缝相对于盖主体的纵向轴线偏移,例如倾斜角度范围为1°-20°。或者,至少一些狭缝在15°-35°的角度范围倾斜。或者,至少一些狭缝在30°-45°的角度范围倾斜,或者更小、更大或中间的任何范围。可选地,狭缝限定三角形部分。
在一些实施例中,该分叉对称地围绕帽脱离器的周界布置。可选地,分叉等距布置。或者,分叉被布置为使得提供至少两个不同尺寸的分叉部分,可选地以细长臂的形式。可选地,成对尺寸相同的分叉部分大致径向排列。
在一些实施例中,分叉部分以几何形状分布在一构造中,当将帽脱离器推到针帽上时需要相对较小的力、且当用帽脱离器拉动帽时具有相对较大的力。可能地,狭缝的相对位置影响施加在帽脱离器上的力的方向性。可选地或另外地,分叉部分的至少一部分的弹性影响施加在盖主体上的力的方向性。在一些实施例中,帽脱离器部分的弹性受这些部分占据的周长的影响。可选地或另外地,帽脱离器部分的弹性受这些部分材料的组成的影响。
在一些实施例中,纵向臂的远侧部分联接到至少两个钩和/或指状物。可选地,钩使帽脱离器的周长小于针帽的周长。在一些实施例中,当盖主体被推到针帽上时,一旦钩通过针帽的顶部槛,较小的周长允许钩悬垂在顶部槛上。在一些实施例中,可选地以纵向臂的形式的分叉部分中的至少一些具有足够的弹性,以从帽脱离器的纵向轴线偏离至少一定程度,从而允许由钩限定的较小周长配合在针帽的较大周长上。
可选地,钩以卡扣机构操作。在一些实施例中,至少一些钩包括朝着帽脱离器的中心轴线延伸的突出部。在一些实施例中,当帽脱离器被推到针帽上时,一旦钩穿过针帽的顶部槛,钩和/或弹性臂就会向中央纵向轴线弹回和/或卡合。在一些实施例中,当对组装到针帽上的盖主体施加拉力时,钩被配置为朝向针帽的底部的轴线方向施加力。可选地,向内突出部形式的钩包括朝向针帽的底部倾斜的突出部,当盖主体被拉动并且突出部被推靠在针帽的顶部槛上时可能形成阻挡扣(resisting clasp)。可选地或另外地,卡扣突起垂直于盖主体的纵向轴线。
在一些实施例中,狭缝的位置影响由被推到针帽上的卡扣施加的阻力,可选地导致在拉动帽脱离器时用帽脱离器拉动针帽。可选地或另外地,狭缝的尺寸影响被保持的卡扣。在一些实施例中,狭缝的位置配置允许当在一个方向推动针帽时弹性部分偏离帽脱离器的中心轴线,但同时当沿相反方向拉动帽脱离器时使得卡扣保持在针帽上,并且防止弹性部分偏离。在一些实施例中,可选地在弹性部分中设置中间狭缝,其可选地定位在帽脱离器的纵向轴线的中间部分附近。在一些实施例中,中间狭缝不会到达帽脱离器主体的边缘。
在一些实施例中,分叉部分可选地围绕帽脱离器的周界(perimeter)对称布置。可选地或另外地,分叉部分相对于中心轴线对称地布置。在一些实施例中,设有四个狭缝,将帽脱离器主体远端分成四个部分,可选地为两个弹性部分和两个刚性部分。弹性部分例如是臂,其可以偏离盖主体的中心轴线以至少允许联接的钩配合在针帽的周界上。刚性部分例如是盖主体的部分,其构造成不远离盖主体的中心轴线偏转。在一些实施例中,弹性部分基本上沿直径定位。可选地或另外地,刚性部分基本上沿直径定位。
在一些实施例中,弹性部分相对于刚性部分占据较小的周长。例如,弹性部分占主体盖周长的10-40%,而刚性部分占主体盖周长的90-60%。可选地,弹性部分占主体盖周长的20-30%,而刚性部分占主体盖周长的80-70%。提供更大的刚性部分和更小的弹性部分具有潜在的优点,因为它们分别有助于部分的刚性特性和弹性特性。
在一些实施例中,提供连接器,例如包含夹紧机构的主体,以组装到帽脱离器盖主体上,可选地将盖主体连接到其他特征。可选地或另外地,连接器用作固定机构并且可选地其形状和尺寸可设置成以增加盖主体的机械稳定性。在一些实施例中,盖主体位于注射器系统内并且连接器可从注射器系统的外部操作。在一些实施例中,帽脱离器包括构造成与连接器互锁的紧固件。可能地,该紧固件阻止盖主体相对于针帽的横向位移。可选地,连接器还包括用户手柄。在一些实施例中,与连接器互锁的紧固件限制沿旋转方向施加的力,可能地阻止针脱离器主体围绕针帽滑动和/或保持针帽脱离器相对于针帽的定向。
本发明的几个实施例的一个方面涉及药物输送系统,例如包括针帽脱离器的自动注射器。在一些实施例中,针被安装到自动注射器中并且被针帽覆盖。随后,将粘合衬垫安装到注射器上。在一些实施例中,移除针帽还导致粘合衬垫的移除。在一些实施例中,针帽脱离器垂直于注射器系统的基座定位,以允许用户获得更直观的拉动方向。
本发明的几个实施例的一个方面涉及一种具有至少两个单独的紧固机构的针帽脱离器。在一些实施例中,第一紧固机构包括至少两个包围臂,其尺寸和形状设置成包围针帽的至少一部分。在一些实施例中,该臂在其纵向轴线的至少一部分中联接,可选地使得臂能够从联接位置枢转倾斜。可选地,当臂的远侧部分远离帽脱离器的纵向轴线倾斜时,该臂限定打开构造,并且当臂不倾斜时,它们限定闭合包络构造。在一些实施例中,第二紧固机构配置成将臂锁定在其闭合构造中,可选地以连接器的形式,该连接器也可将位于注射器系统内部的臂连接到注射器系统的外部。
在一些实施例中,闭合构造通过使构件围绕针帽而限定。通过使构件间隔开以具有大于针帽直径的直径,可选地至少与针帽的最大直径一样宽来,从而限定打开构造。在一些实施例中,所述臂设置有指状物,一旦臂处于它们的闭合头灶,则指状物被配置成悬置在针帽的顶部槛上。可选地,当正在拉动帽脱离器时,连接器使臂保持其闭合构造,并且指状物向下按压所述帽并将其从针上取下,可选地基本上沿向下的轴向方向取下。
本发明的一些实施例的一个方面涉及一种装置保护盖,其允许针帽脱离器进入装置的内部部分,并且设计成在脱离器与其用户手柄组装在一起之后组装到针帽脱离器和其用户拉手柄上。在一些实施例中,保护盖包括多个层,可选地至少一个粘合层和一个保护粘合层的粘合表面的衬垫层。在一些实施例中,保护盖被设计为通过用户手柄沿着线性方向拉动针帽脱离器而被移除。可选地,只有保护盖区域的一部分连接到注射器,而延伸边缘从连接部分的端部延伸。在一些实施例中,延伸的边缘被折叠和/或弯曲以面向连接部分定向,可选地通过将延伸的边缘放到用户手柄上。
在一些实施例中,保护盖包括至少两个孔(aperture)。可选地,第一孔允许针帽脱离器插入到注射器内部部分中。在一些实施例中,第一孔的尺寸设计成匹配针帽脱离器的圆周形状,可选地比针帽脱离器宽。潜在的优点在于,当所述装置粘附于患者并且所述针穿过该孔时,保持第一孔足够小以允许足够的稳定性。设计孔使其宽度小于人手指的宽度的另一潜在的优点是防止用户将他的手指插入针区域,例如,宽度小于15mm,和/或小于10mm,和/或小于5mm。在一些实施例中,帽脱离器主体在需要插入孔中的区域中没有向外突出部,以便保留对主体自身宽度所允许的小孔宽度的选择(option)。
还可选地,第二孔允许装配在用户手柄上。在一些实施例中,用户手柄被提供为具有长尺寸和短尺寸。可选地,第二孔的尺寸设计为细长狭缝,其长度比手柄的短尺寸更长并且比长尺寸更短。在一些实施例中,通过首先将孔面向较短尺寸定向,然后旋转盖体的边缘使得细长孔向较长尺寸滑动,可选地最终定向成面向长尺寸,而使细长孔组装在手柄上。在一些实施例中,当将衬垫放置在手柄上时,帽脱离器和/或针帽上没有施加力。或者,施加小于50g、和/或100g、和/或150g的力。
在一些实施例中,边缘通过手柄随孔朝向长尺寸滑动而变宽以及通过将孔的边缘限制在手柄的宽部分上(比孔宽)而稳定就位。或者,该边缘被引导穿过手柄的最宽部分并到达较窄部分,导致孔边缘在作为肩部的宽部分上悬垂。可选地或另外地,手柄在该边缘越过它之后旋转,使得手柄的长尺寸与孔的长度成一定角度,由此防止该边缘在其通过的方向上滑动。可选地或另外地,该边缘从长尺寸的中心向偏移方向滑动,使得孔与手柄的长尺寸错位。
在一些实施例中,至少一个孔的边缘的至少一部分还包括呈刚性层形式的支撑层,其刚性足以提供机械稳定性,以防止在拉动盖体时施加的力下弯曲。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/或示例中阐述的部件的构造和布置和/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。
示例性实施例
1示例性的针帽脱离器
现在参考附图,图1A-E示出了根据本发明的一个实施例设计成移除针头盖体的针帽脱离器100。在一些实施例中,针帽脱离器100被设计成使得施加在针头盖体上的力不会干扰包围无菌针头的针帽的无菌状态。
在一些实施例中,针帽脱离器100具有构造成至少部分地覆盖针帽的细长的盖主体120。在一些实施例中,细长主体120的尺寸和形状被设置成可选地紧密地包围针帽。细长主体120可选地包括孔道(bore)124。例如,主体120和/或孔道124可以是圆柱形的。或者,主体120和/或孔道124的一部分可以是圆锥形的,例如锥形和/或具有圆锥部分形状和/或漏斗形状。主体120具有远端B,该远端B在一些实施例中被发现接近针帽的顶部部分,即具有针容纳孔道的部分。主体120具有近端A,该近端A在一些实施例中被发现接近针帽的底部部分,即最靠近针尖的部分。
在一些实施例中,细长部分120包括两个分叉,可选地将主体120分成至少两个部分,可能为部分130和/或部分150。在一些实施例中,至少两个部分中的至少第一部分130具有弹性特性,可选地,两个部分呈纵向臂的形式。可选地或另外地,至少两个部分中的至少第二部分150具有刚性特性,例如,其比第一部分130更硬。在一些实施例中,弹性部分130具有足够的弹性以从盖主体的中心轴在1°-5°的角度范围偏离。或者,弹性足以使得在10°-15°的角度范围偏离。或者,弹性足以使得在15°-20°的角度范围偏离。在一些实施例中,达到大于弹性范围的角度导致臂的塑性变形,可选地导致减少臂到其原始位置的弹性咬合(resilient snapping)。或者,超出范围的较高阈值的偏离导致臂的断裂。
在一些实施例中,弹性和/或刚性受由分叉(可选地沿着主体120的纵向轴线的它们的纵向长度和/或位置)产生的狭缝101的尺寸、形状和/或位置的影响,。可选地或另外地,狭缝101的宽度影响其相邻部分的弹性。狭缝101的纵向长度的可选范围在约5mm和约20mm之间。或者,狭缝101的长度在7mm和10mm之间。狭缝101宽度的可选范围在0.3mm和3mm之间。可选地,狭缝101的宽度是2mm。
可选地或另外地,弹性和/或刚性通过围绕主体120的周长的狭缝101的位置确定并且因此根据由弹性部分130占据的周长长度和/或由刚性部分150占据的周长长度来确定,其由狭缝101的位置限定。在一些实施例中,狭缝101将主体120的远侧部分的划分限定为相对弹性部分130和相对刚性部分150。可选地,部分130相对于部分150是弹性的,并且部分150相对于部分130是刚性的。在一些实施例中,弹性部分占据主体120周长的50%。或者,弹性部分占据主体120的周长的40%。或者,弹性部分占据主体120的周长的30%。或者,弹性部分占据主体120的周长的20%。或者,弹性部分占据主体120的周长的10%。
在一些实施例中,提供至少一个中间狭缝104,潜在地增加其弹性,可选地狭缝104在弹性部分130中。可选地,中间狭缝104被主体120围绕而不一直延伸到120的边缘。在一些实施例中,中间狭缝104被定位在两个狭缝101之间的中央。可选地或另外地,中间狭缝104相对于狭缝101不对称地定位,潜在地引导向对施加在装置100上的力反应有利方向。可选地或另外地,中间狭缝104被定位在狭缝101中的仅一个的附近。可选地,中间狭缝104具有与狭缝101相同的尺寸。或者,中间狭缝具有更小或更大的长度。可选地或另外地,中间狭缝具有更小或更大的宽度。
在一些实施例中,弹性部分130和刚性部分150具有不同的长度。可选地,弹性部分130朝向装置100的远端延伸超过刚性部分150。在一些实施例中,至少一些弹性部分在其远端包括卡扣132。在一些实施例中,卡扣132被配置成将主体120卡扣到针帽的顶部部分上。可选地,卡扣132形成比针帽的周长更小的周长。在一些实施例中,由于弹性部分130的弹性,当装置100被推到针帽上时,弹性部分130被引导远离主体120的中心轴线。可选地,一旦卡扣132通过针帽的顶部部分,它们就卡合到它们的原始位置,基本上将针盖100扣紧在针帽上和/或扣紧在针盖的顶部上和/或钩在针帽的顶部槛上。可选地,卡扣132向内倾斜和/或楔入针帽的顶部和/或顶部槛中,相对于针帽的中心纵向轴线倾斜。在一些实施例中,卡扣朝着针帽的中心纵向轴线偏离。可选地,当使用帽脱离器来拉动该帽时,卡扣132的角度向内(例如朝向该帽的中心轴线)拉动弹性部分130的远侧部分。
在一些实施例中,针盖100还包括用户手柄190,可选地如图1所示以环的形式。可选地,用户手柄190通过连接器相互连接到盖主体120,可选地具有用于连接到盖体120的连接器主体170和连接器基座174,潜在地能够更容易地抓住帽脱离器100。在一些实施例中,连接器主体是独立的特征,其(可选地通过连接器环172)连接到主体120,其还可选地包括被配置为使环172和主体120互锁的紧固装置410,例如如图4和5所示。或者,连接器基座170被设置为主体120的延续部分,而不是单独的特征。可选地,紧固件410配置成将主体盖与连接器互锁,使得盖主体120相对于其包围的针帽的横向移动被抑制。
在一些实施例中,盖主体120包括凹部420,凹部420可选地配置成与针帽中的突出的纵向引导件互补,由此引导盖主体插入针帽的方向。在一些实施例中,提供至少两个凹部420。或者,提供至少3个凹部。在一些实施例中,凹部设在盖主体的近侧部分中。
可选地,连接器基座170和/或主体120包括互补的纵向部分,当将两者组装在一起时,其可选地便于连接器基座170相对于主体120的定向。纵向部分可选地包括凹槽。可选地或另外地,纵向部分包括突起。在一些实施例中,主体120的内部部分包括互补的纵向部分,其配置成与设置在针帽中的部分互补,潜在地有助于主体120相对于针帽的正确定向。另外潜在地,互补部分可以帮助减小将盖120组装到针帽上所需的力。
2药物输送装置的示例性系统中的针帽脱离器的示例性用法
在一些实施例中,针帽脱离器与药物输送注射器系统一起使用。可选地,在系统已经与容纳在具有针的药筒中的药剂预装配之后,将注射器提供给用户。可选地,针被嵌入在注射器系统的壳体内和/或对用户不可见。可能需要药剂和针在他们被使用或即将使用之前保存在无菌状态下。例如,将装置提供给用户时针仍然受针帽保护可能是有益的。可选地,针帽内嵌在壳体内。根据本发明的一些实施例提供的针帽脱离器和/或手柄被组装到针帽上,可能具有存在于壳体内的内部部分,同时具有在壳体外的外部部分并且可供用户拉动。
现在参考图2,其示出了自动注射器形式的示例性药物输送装置,其处于例如运输安全的安全状态,并且具有至少部分嵌入的帽脱离器100。在一些实施例中,粘合衬垫250覆盖该装置的激活区域(activation zone)和/或粘合剂(adhesive)。可选地,粘合衬垫250与帽脱离器100相关联,使得拉动帽脱离器100也导致粘合衬垫250的脱落。在一些实施例中,帽脱离器100用作联接器,(可选地通过剥离保护盖体层)可选地同步脱除针帽并开启该装置的激活区域。
在一些实施例中,注射器系统的粘合剂部分设有两部分,主粘合剂212和次粘合剂214,可选地,粘合剂214具有比粘合剂212更小的接触面积。提供至少两个粘合剂部分212和214的潜在优点在于,由于具有较小接触面积的粘合剂可能首先脱离,因此可引导地将装置从使用者身体移除。
在一些实施例中,帽脱离器100和/或其相关的粘合衬垫250与电池隔离器相关联。可选地,一旦拉出帽脱离器100和/或剥离粘合衬垫250,电池隔离器也被移除,从而允许对注射器系统通电。在一些实施例中,一旦通电,注射器不能再被关闭和/或以其原始状态重新装入。可选地或另外地,一旦电源开启,移动设备就会收到警报。可选地,在注射器系统中提供条形码,用于使移动设备与注射器系统进行通信。
图2A示出了示例性的注射器系统,其具有注射器壳体200和操作按钮201,并且具有帽脱离器装置100,其可选地接近操作按钮201。根据一些实施例,注射器系统包括(可选地由粘合衬垫250覆盖的)两部分粘合剂214和212。在一些实施例中,粘合衬垫250包括用于覆盖部分212和214的顶部部分252,可选地,粘合剂212和粘合剂250包括用于允许针和/或针帽和/或针帽脱离器从外部壳体200进入的孔。在一些实施例中,粘合衬垫250还包括底部部分254,其可选地通过弯曲部256连接到顶部部分252。在一些实施例中,底部部分254与针帽脱离器100相关联,可选地具有用于允许装置100从壳体200内延伸穿过顶部部分252并穿过底部部分254的孔。可选地,底部部分254位于手柄190和连接器底座174之间。在一些实施例中,连接器底座174包括板,其可选地具有比主体120的孔道124更大的直径。可能地,一旦拉动手柄190,连接器基座174拉动粘合衬垫底部部分254,该粘合衬垫底部部分254通过弯曲部256导致顶部盖体252从该装置的最靠近弯曲部256的端部开始剥离。在一些实施例中,如图2C所示,连接器170包括定向特征,诸如例如梁178,可选地其尺寸和形状设置成以装到壳体200中,例如在狭缝270处。可能地,定向特征178配置成引导帽脱离器装置以特定的旋转方向插入。可选地,至少一个紧固件350设置在连接器170和/或盖主体120中,可能地设定连接器170与主体120的方向。
图2B示出了注射器系统的实施例,该注射器系统具有与药筒206的套管204相关联的针帽202,搁置在注射器的壳体200的框架上,可选地,注射器系统通过马达208自动操作,可能地推动活塞210。在注射器(其可选地由前盖250覆盖)的近端施加压力可选地将针保护器214推靠在框架上。可选地,在注射器的近端上施加压力将不会启动注射器和/或不会使针脱离防护。针帽202可选地用作物理防护罩,覆盖与套管204相关联的针头。
可选地,针帽202包括刚性外壳和无菌橡胶芯。当针盖202安装在无菌针头上时,橡胶芯可以保护针头的无菌性和/或所述壳可以保护针头免于引起粘连危险。可选地或另外地,针头覆盖有保护无菌和/或防止粘连危险的单个盖体(橡胶或刚性的)。
例如,预填充注射器(prefilled syringe)可以被安装到具有针的自动注射器中,其中针已经被针盖202覆盖。在运送注射器之前,可以将粘合衬垫250安装到注射器上。在一些实施例中,针帽脱离器100被推到帽202上,可选地另外用作针帽保护器。在一些实施例中,帽脱离器100包括接合帽202的扣钩(例如卡扣132)。当从注射器移除针帽脱离器100时,扣钩132可以拉开针帽202。
3一种包括粘合衬垫的针帽脱离器
现在参考图3,示出了可选地具有盖体120和/或粘合衬垫250和/或手柄190的针帽脱离器的透视图和侧视图。
图3A和3B示出了根据本发明示例性实施例的注射器针帽脱离器和粘合衬垫。帽脱离器包括例如手柄190和/或针帽盖体120和/或用于覆盖粘合剂212/214和/或用于覆盖注射器系统的激活区域的粘合衬垫250。手柄190和/或盖体120和/或盖体250可选地连接到电池隔离器。可选地取下盖体将注射器置于启用状态。
在一些实施例中,针帽脱离器100用作粘合衬垫250的剥离器。例如,可选地帽脱离器100铰接和/或为柔性的。可选地,手柄190位于帽脱离器100的中心。在一些实施例中,手柄190不会突然拉动粘合衬垫250远离粘合剂214/212的整个表面(可能需要较大力以克服大表面上的粘附力的作用)。当手柄190被拉动时,帽脱离器100的中心部分可选地与粘合衬垫底部部分254一起移开。例如,可选地盖体254以这样的方式被拉开,以便随着顶部部分254一点一点地剥离而剥离粘合衬垫弯曲部256。可选地从主粘合剂212的最末端部边缘剥离和/或可选地向另一端剥离,最后从次粘合剂214移除顶部部分252。
在一些实施例中,粘合剂212被提供到铰接板301上。可选地,一旦取下针帽脱离器100和盖体250,用户可以将该装置附接到注射部位上并且可选地将铰接板301折叠成平行于该装置。在一些实施例中,传感器感测铰接板301相对于该装置的取向,仅当两者对准时才允许操作。可选地或另外地,一旦板301平行,机械机构允许注射操作,例如通过倾斜诸如内板的阻挡特征。
现在参考图3C,其示出了根据本发明的一些实施例的组装到针帽上的帽脱离器装置的侧视图的截面图,所述针帽用于防护注射器系统的针头。在一些实施例中,盖主体120被配置成推到针帽202上,该针帽202防护针302的无菌状态。可选地,将主体120推到帽202上不会干扰针的无菌状态。在一些实施例中,盖主体120包括管状形状,可选地为圆锥形。或者,管状形状是圆柱形的。或者,只有盖主体120的一部分被限定为管状,并且该部分潜在地联接由盖主体120提供的至少两个臂。或者,盖主体为分叉的以限定至少两个臂,可选地弹性。
在一些实施例中,尽管具有周长比帽202的最大周长更小的元件,盖主体120的弹性部分允许其被推到帽202上。
现在参考图3D-3G,其示出了装置盖体的示例性实施例,可选地保护可能用于将装置底座联接到患者身体的粘合性质。
在一些实施例中,壳体200在其基座包括装置盖体300。在一些实施例中,盖体300包括至少两个层,一个是粘合层,另一个是用于保护粘合层的粘合表面的衬垫。在一些实施例中,盖体300的粘合表面帮助用户将注射器长时间稳定地保持在患者皮肤上。可选地,粘合表面在盖体300的整个表面上是间断的。在一些实施例中,盖体300在点308处被分隔,将装置的粘合表面在主要部分250与次要部分252之间分开,可选地部分252具有较小表面积,由于较小的粘附面积相对于较大的粘附面积易于取出,因此潜在地引导用户朝向装置被移除的方向。在一些实施例中,折叠包括折弯和/或拱起,和/或弯曲和/或缠绕和/或扭曲。可选地,部分250和/或部分254具有圆形形状。可选地或另外地,它们可以具有除圆形以外的形状,例如椭圆形、矩形和/或不规则形状。
在一些实施例中,盖体300包括用于连接到壳体200的基座的至少一个部分。在一些实施例中,盖体300包括延伸超过壳体基座的表面区域的延伸部254。可选地,延伸部254在部分256处被折叠以定位成面对盖体300的部分250。
在一些实施例中,盖体300包括至少两个孔305和306。在一些实施例中,包括在部分250中的第一孔306的尺寸和形状被设定为允许针帽脱离器主体120穿过它并插入包括针的注射器装置的内部部分中。可选地,孔306延伸穿过粘合衬垫和保护衬垫,以及任何其他包括保护盖体300的层。在一些实施例中,孔306包括与针帽脱离器主体120的圆周形状相匹配的圆周形状,并且可选地其宽度比脱离器主体120的宽度不宽于约1mm,或约0.7mm,或约0.5mm,或约0.3mm。
可选地,粘合衬垫在点256处折叠,形成延伸部254,该延伸部254将线性开启力引导至从折叠边缘开始的引导剥离力。在一些实施例中,第二孔设置在盖体300的延伸部254中,盖体300的延伸部254通过弯曲部分256延伸至连接装置基座的盖体部分,例如部分250和/或252。可选地,第二孔305用于将部分254组装到针帽脱离器主体120的连接器上。在一些实施例中,针帽脱离器装置用作联接器,(可选地通过连接器170)将针帽连接在其远端侧和将用户手柄190连接在其近侧。在一些实施例中,用户手柄包括与所述联接器相对的突出元件,例如,靠近针帽脱离器100的近端。
在一些实施例中,第二孔305包括细长孔口。在一些实施例中,细长孔口的尺寸被设置成拉过从针帽脱离器主体120延伸的用户手柄190,可选地用户手柄190通过连接器170连接到针帽脱离器主体120。可选地,用户手柄190包括具有长尺寸194和短尺寸192的突出元件。在一些实施例中,细长孔口305具有比短尺寸192长并且比长尺寸194短的长度。在一些实施例中,用户手柄190具有朝向其与连接器170的连接处的加宽部分,可选地结束于肩部195,如图3E所示。在一些实施例中,孔口305的宽度比由肩部195限定的宽度短。在一些实施例中,孔口305至少部分地由足够弹性和/或弹力的材料制成,以允许将孔口推过肩部,尽管其宽度更短。可选地,延伸部254通过悬伸于肩部195而被保持在手柄190上方。可选地或另外地,肩部195包括手柄190的狭窄部分的最宽部分,其尺寸不小于孔口305的宽度。可选地,孔口305通过摩擦力稳定在肩部上。
在一些实施例中,附加的支撑层与保护盖接合,可选地是间隔的并且在盖体300的区域上不连续。在一些实施例中,支撑层由足够刚性的材料制成以增加保护衬垫的刚性,潜在地为盖体300提供机械强度。可选地,支撑层至少设置在包括孔305和306的部分中。在一些实施例中,在突出部256中未找到支撑层。
在一些实施例中,注射器壳体设置有盖体300,盖体300至少部分地连接到其基座,可选地通过粘合层连接。可选地,通过将具有带帽针的药筒互锁在壳体200的内部部分中来组装注射器,使得药筒中心轴垂直于盖体,并且带帽针与孔306居中对齐。在一些实施例中,针帽脱离器的远端通过孔306插入壳体200的基座的内部部分中,并且被推过带帽针上。可选地,盖体120的近端保持向壳体200的外部突出。
在一些实施例中,用户手柄连接到主体120的近侧部分,可选地通过连接器170。在一些实施例中,用户手柄190的特征在于突出元件从基座向外延伸并具有短尺寸194和长尺寸192。在一些实施例中,延伸部254通过首先定向孔305面向手柄190的较短尺寸194,随后将盖延伸部254旋转过手柄直到孔305定向成面向较长尺寸192而折叠在用户手柄190上。
在一些实施例中,孔306和305居中对齐。可选地或另外地,孔305沿着手柄190的长尺寸192滑动,使得纵向轴线不与孔306和/或手柄190居中对齐。可能地,相对于手柄190滑动孔305进一步稳定其位置并且防止孔305沿相反方向旋转。可选地,延伸部256在部分250和延伸部254之间延伸产生孔305相对于手柄190的滑动。
在一些实施例中,手柄190包括从近端方向延伸并当接近手柄远端时加宽的加宽部分,近端限定为远离壳体200,远端限定为接近壳体200,可选地最宽的是肩部195。在一些实施例中,加宽部分穿过孔305,然后孔305受到加宽部分的约束,潜在地通过摩擦力保持在适当位置。或者,加宽部分肩部195的远侧较窄部分穿过孔305,,并且可能地通过使孔305的边缘悬伸在加宽部分和/或肩部195上使延伸部254稳定就位。
在一些实施例中,针帽脱离器100用作盖体300(可选地,至少用于它的保护衬垫层)的剥离器。例如,针帽脱离器100通过孔口305与延伸部254接合。可选地,与针帽脱离器主体120可选地连接的用户手柄190不会立即将盖体300直接拉离装置基座的整个表面(这可能需要较大的力来克服大表面上的粘附力)。在一些实施例中,当手柄190处于拉动状态时,延伸部254拉动部分256,接着是部分250。在一些实施例中,延伸部304引导部分250的剥离开始方向。在一些实施例中,折叠部分256可张开、展开、拉伸和/或弯曲以允许建立一定距离。可选地,部分256的展开以及延伸部304的剥离将远离壳体200的线性力转换成在粘合剂覆盖粘合盖体的粘合剂边缘处的剥离力。剥离力可以可选地沿着壳体200的基座的表面和/或剥离力可被引导为以一定角度远离该表面。例如,剥离的角度可以在例如60-90度和/或30-60度之间和/或0和30度之间的范围内。
图3G示出了根据本发明的一些实施例的盖体300的可能结构的细节,具有至少两个包括表面形成有粘合剂的激活区域。在一些实施例中,装置的壁(例如壳体200的基座)可以具有激活表面(例如粘合剂250a和/或250d)。可选地,粘合剂可以分层形成。例如,如图3G所示,盖体300的粘合部分包括三层。第一层250a包括双面粘合剂。粘合剂可以例如将半刚性膜250b结合到基座212。膜250b可以延伸超出基座的边缘,可选地在延伸部304中延伸。可能地,超出基座边缘的半刚性延伸部在一些实施例中可以使注射器更坚固地粘附于用户的皮肤。在一些实施例中,提供支撑膜250c。
在一些实施例中,粘合盖体移除力的范围在10-150克/厘米(gr/cm)之间。粘合盖体移除力可以低于粘合剂膜250a的弯曲惯性。例如,这可以在移除盖体时防止膜250b的弯曲。膜的外表面可以可选地包括激活表面。用于本申请目的的激活表面(active surface)可以是具有激活形态(active modality)和非激活形态(inactive modality)的表面,激活形态中该表面与促进装置功能的外部元件相互作用,以及非激活形态中它基本上不与外部元件相互作用。例如,在启用注射器粘合剂250d之前可以不激活和/或由粘合盖体250e保护。
可选地,部分250、254和/或252具有不同层数。在一些实施例中,部分254包括将基座214连接到衬垫252c的粘合层252a及其支撑层252b。在一些实施例中,延伸部254包括层254a形式的部分250的延伸部,并且还包括连接到支撑层254c的粘合层254b。
4示例性的分叉式针帽脱离器
现在参考图4,其示出了根据本发明的一些实施例的针帽盖主体120的各种视图。在一些实施例中,盖主体120被设置为具有孔道124的圆柱体。在一些实施例中,主体120的远侧部分是分叉的。可选地,至少两个狭缝101提供分叉部分,可选地产生至少两个不同部分。
在一些实施例中,提供至少4个狭缝101,使得在主体120的远端处可获得至少4个不同部分。可选地,该部分中的至少两个包括弹性部分130。可选地或另外地,该部分中的至少两个包括刚性部分150。可选地,至少两个弹性部分130基本彼此径向定位,和/或可选地,至少两个刚性部分150基本彼此径向定位。
在一些实施例中,弹性部分130具有延伸超过针帽的顶部槛的长度,例如超过0.5mm,1mm或超过2mm,或超过3mm,或者任何更小、更大或中间的长度。可选地,弹性部分130延伸超出孔道124的顶部边缘的长度在约3mm至约10mm的范围内。在一些实施例中,延伸的弹性部分包括构造成悬伸于针帽202的顶部槛上的卡扣132。在一些实施例中,卡扣132包括可选地延伸到孔道124的内部径向方向上的突出部。可选地,突出部具有大约0.2mm的长度。或者,突出部具有约0.1mm的长度。突出部具有大约0.3mm的长度,或者任何比本文提到长度更小、更大或中间的长度。
在一些实施例中,设置中间狭缝104,可选地不一直延伸至孔道124的远侧边缘,可选地设置在弹性部分130中。可能地,定位狭缝101和/或104的构造和/或它们的尺寸和/或形状影响弹性部分130的弹性程度和刚性部分150的刚性程度。在一些实施例中,狭缝101和/或104的配置和/或形状和/或尺寸被配置为允许少量的力将主体120推到针帽上,以及允许大量的力将主体120拉离针帽,可选地导致在拉动主体120的同时移除针帽。例如,少量的力在约50g至约400g的范围内。或者,少量的力在约100g至约300g的范围内。或者,少量的力在约100g至约150g的范围内。可选地,大量的力在大约0.5-1.5Kg的范围内。或者,大量的力在约0.75Kg至约1.25Kg的范围内。或者,大量的力不超过1Kg。
在一些实施例中,主体120包括至少一个紧固件410,可选地具有紧固件锁定件412,例如突出部,可选地位于主体120的近侧部分的突出部。可能地,紧固件410被配置成与连接器主体170中的互补部分卡合和/或锁定,从而可能地使主体120稳定就位。可选地或另外地,连接器主体170将主体120与手柄190连接。提供多个部件的潜在优势是在组装过程中实现更多的自由度。在一些实施例中,提供至少3个紧固件410,可选地彼此等距离。
现在参考图4E和4F,其示出了根据本发明的一些实施例的针帽脱离器的另一个实施例,并且具有至少四个紧固件410。图4E示出了主体盖120的前视图,并且图4F示出了当连接到连接器主体170并且包围帽202时主体120的前视图,该帽202防护连接到套管205的针,套管204与注射器206联接。紧固件410可选地以其位置联接到分叉的位置。在一些实施例中,紧固件410设置在盖主体120的刚性部分150中。可选地,盖主体120包括可能非直线形式的裂缝430。裂缝430的潜在优点是允许更多的灵活性。非直形式的潜在优点是可以提高稳定性。
现在参考图4G和图4H,其示出了根据本发明的一些实施方式的被推在针帽上的帽脱离器的横截面前视图,其中图4G示出了沿针帽被推入中间位置的针帽脱离器,图4H示出了卡合入位之后的针帽脱离器,并具有悬伸在针帽的顶部槛上的卡扣132。
在一些实施例中,帽的周界是不均匀的,并且可选地其顶端(即针从注射器主体向外伸出的位置)可选地包括较大的周界。在一些实施例中,钩132被配置成限定周界,该周界在其松弛的未受压状态下可以包含帽202的底部部分的周界,但不能包含帽202的顶部部分的周界。在一些实施例中,帽202的顶部部分包括用于扣紧钩132的凹陷。
现在参考图4I,示出了药筒206的局部透视图,其具有针帽202用于保护与套管204连接的针,与根据本发明的一些实施例的帽脱离器装置组装。在一些实施例中,钩132被配置成使弹性部分130偏离针帽202的中心轴线,可选地当通过比由钩132限定的更大的周界时使其偏离。在一些实施例中,钩132被配置成可选地一旦钩穿过帽202的顶部部分就悬伸到帽202的顶部槛402上。
在一些实施例中,钩132在朝向脱离器装置的中心轴线的方向上包括突出部。可选地,突出部132垂直于盖主体120的纵向轴线。可选地,突出部朝盖主体120的近侧部分倾斜。在一些实施例中,当将盖主体120相对于帽202拉动时,突出部132的倾斜影响其阻力。可选地,盖主体120上的拉力导致突出部132相对于盖体120的纵向轴线增加它们的倾斜角度,可能引起阻止盖主体120的拉动的机械干涉,而不拉动针帽202。
5用于针帽脱离器的示例性连接器
现在参考图5,示出了根据本发明的一些实施例的连接器170形式的连接器。在一些实施例中,连接器主体170包括孔道574,孔道574的尺寸和形状被设置成配合诸如盖主体120的针帽脱离器盖主体和/或配置成将针帽安装在近侧部分。在一些实施例中,连接器主体170设置有至少一个互补部分,其被配置为将连接器主体170锁定在盖主体120上,可选地通过紧固件410。在一些实施例中,提供了连接器咬边578(undercut),其包封连接器孔道574的至少一部分并且可选地构造成扣在至少一个紧固件410上。在一些实施例中,紧固件410的形状被设置成允许连接器主体170沿朝向盖主体120的远侧部分的方向容易地插入,但是可选地,一旦咬边578已经穿过紧固件位置,则将连接器170夹持到盖主体120。在一些实施例中,紧固件410配置成防止针帽脱离器盖主体相对于针帽的横向移动。
在一些实施例中,手柄190可选地通过连接器572连接到连接器主体170。可选地或另外地,手柄190与连接器主体170和/或连接器基座174一起被制成单个单元。
6将针帽脱离器组装到针帽上
现在参考图6,具有流程图,示出了根据本发明的一些实施例示例地将针帽脱离器组装到针帽上;在一些实施例中,帽脱离器主体与针帽中心轴线602对齐。对准可能防止当将脱离器推到帽上时施加过度的力,这可能导致伤害针,和/或干扰针帽内部区域的无菌性。
在一些实施例中,一旦帽脱离器基本上与针帽对齐,将帽脱离器推向针帽604,可选地通过将针帽的近端插入帽脱离器的远端并且将帽脱离器的远端朝针帽的远端的方向推动。在帽脱离器主体中具有分叉,可能引起帽脱离器中的弹性部分。在一些实施例中,一旦盖体被推动,包括可选地限定比针帽的圆周更小的圆周的卡扣的弹性部分被推离帽脱离器的中心纵向轴线。
在一些实施例中,当弹性卡扣到达针帽606的顶部部分之外时,帽脱离器的推动停止。在一些实施例中,互锁机构防止将帽脱离器推出超过针帽上方(例如紧固件410)的特定点。可选地或另外地,当传感器感测到抵抗推动的力的减小时,帽脱离器的推动停止。在一些实施例中,由于弹性部分的弹性特性,卡扣弹起就位,可选地导致卡扣悬伸到针帽的顶部槛上。
可选地,例如呈夹具形式的连接器被组装到帽脱离器主体608的近端上。连接器可能将帽脱离器主体相对于注射器的壳体保持静止,和/或允许将帽脱离器连接到附加特征,例如用户手柄和/或衬垫覆盖操作特征,例如粘合剂部分和/或电池隔离器。
在一些实施例中,连接器被推到脱离器主体上直到其互锁到位610,可选地通过与设置在帽脱离器主体中的至少一个紧固件410互锁。
可选地或附加地,夹具在包封到针帽上之前互连到帽脱离器主体,可选地已经与用户手柄相关联。
7将具有粘合衬垫的针帽脱离器组装到针帽上
现在参考图7,示出了根据本发明的一些实施例的流程图,其说明与装置盖体(诸如粘合衬垫)相关联的针帽脱离器的示例性组装过程。
在一些实施例中,首先完成将帽脱离器主体的中心轴线与针帽702的中心轴线对准以防止不必要的力施加。在一些实施例中,如在604中所示,将帽脱离器推到针帽704上,并且当主体扣紧在帽706上时可选地停止推动,可选地通过弹性卡扣停止推动。
在一些实施例中,帽脱离器装置被插入设置在装置盖体708中的第一孔口中,所述装置盖体708可选地包括粘合衬垫。在一些实施例中,将连接器组装到帽脱离器712上,可选地将盖体固定到帽脱离器上。
在一些实施例中,可选地在延伸超过注射系统的边界的部分处,装置盖体被弯曲710,并且连接器主体被插入设置在盖体714中的第二孔口中。可选地,在将用户手柄组装到连接器716上之后,盖体的第二部分被固定。
8自动针式注射器装置的示例性组装过程
现在参考图8,其示出了根据本发明的一些实施例的自动针式注射器装置的组装过程的示例性过程。
在一些实施例中,提供针式注射器壳体的基座802,可选地附接到保护盖。在一些实施例中,保护盖包括至少一个粘合层,可选地用于将注射器定位和稳定在用户的身体上。在一些实施例中,粘合层由作为保护衬垫的第二层保护。
在一些实施例中,可选地具有弯针通路的预填充药筒被定位在基座内部并互锁以与其接合804。可选地,药筒被定位成使得药筒的中心轴线平行于底座-盖体。在一些实施例中,药筒包括带帽的弯曲针。可选地,弯曲的针与设置在基座内的孔口居中对齐,潜在地允许从注射器壳体的外部进入到可选地驻留在注射器壳体内的针。在一些实施例中,覆盖基座的装置盖体还包括第一孔,可选地匹配于基座的孔口。
在一些实施例中,针帽脱离器通过装置盖体的第一孔从基座的外部部分进入基座的内部部分806。可选地,将针帽脱离器推到带帽针上。在一些实施例中,第一孔的尺寸和形状设置为至少符合针帽脱离器的周界。在一些实施例中,针帽脱离器在其远端被放置在带帽针上,可选地位于注射器的内部部分。可选地,针帽脱离器在其近端包括用户手柄,潜在地用于将针帽脱离器与针帽脱离。
在一些实施例中,针帽脱离器在被附接到用户手柄的同时被放置在带帽针上。可选地,未附接到基座的外部部分的盖体边缘被折叠并附接到用户手柄808。在一些实施例中,当线性地拉动用户手柄时,盖体边缘与手柄及其连接的针帽脱离器一起被拉动,同时将附接到装置的盖部从边缘的方向上剥离。
在一些实施例中,用户手柄包括具有短尺寸和长尺寸的突出构件。可选地,通过将盖体的第二孔穿过用户手柄的突出部分,将盖体附接至用户手柄。在一些实施例中,通过将盖体的第二孔定向成面向手柄的短尺寸并且将盖体旋转到突出元件上直到第二孔被定向为面向长尺寸,而将第二孔组装到用户手柄上。
9示例性的多部件帽脱离器
在一些实施例中,帽脱离器设置为具有多个部件。可选地,仅在组装到针帽上时和/或之后将这些部件组装到完整的帽脱离器上。
现在参考图9A-B,其示出了根据本发明的一些实施例的多部件帽脱离器的示例性实施例。在一些实施例中,提供具有至少两个细长臂930的针帽脱离器,其尺寸和形状设置为配合针帽壁902的纵向部分,可选地用于保护套管904。可选地,臂的远侧部分934包括封闭构件932,可选地其尺寸和形状设定为配合针帽的顶部表面。在一些实施例中,连接器主体970的尺寸和形状被设定为包围至少两个臂930,可选地在其近侧部分936处,可选地导致它们卡在帽上。
在一些实施例中,臂930的中间部分938包括至少一个紧固构件;例如环912。可选地,构件912被配置成与设置在连接器主体970内的紧固件972互锁。
图9A示出了帽脱离器的示例性打开构造,其具有在其远侧部分934中远离纵向轴线倾斜的臂930,可选地同时通过环912保持在一起。图9B示出了示例性闭合构造,其示出了围绕针帽的臂930的包络以及由连接器970提供的可选的固定机构,该固定机构可选地还包括用户手柄919。
10将多部件帽脱离器组装到针帽上
现在参考图10,示出了根据本发明的一些实施例的说明多部件针帽脱离器的示例性组装过程的流程图。
在一些实施例中,针帽被放置在多部件帽脱离器1002的臂之间。具有多个部件的潜在优点是由臂限定的周界具有灵活性。可选地,当臂打开时,它们限定比针帽的周界更大的周界,潜在地允许它们以相对小的力和/或以帽的中心轴线与帽脱离器的中心轴线对准的低精度放置。
可选地,当将固定连接器推到臂的近端上时1006,臂围绕帽1004,使其朝向针帽倾斜。在一些实施例中,一旦固定连接器与臂互锁1008,将针帽脱离器牢固地保持在针帽上,从而将臂固定在针帽上。在一些实施例中,连接器通过夹紧机械地联接两个臂的联接元件而与臂互锁,可选地,联接元件是环。
在一些实施例中,施加不超过25g的力以将连接器与臂互锁,导致其闭合构造。或者,施加不超过50g的力。或者,施加不超过100g的力。在一些实施例中,为了拉动针帽,施加不超过0.5Kg的力。或者,施加不超过0.7Kg的力。或者,施加不超过0.9Kg的力。或者,施加不超过1Kg的力。或者,施加不超过1.2Kg的力。或者,施加不超过1.5Kg的力。
11具有单臂的针帽脱离器的示例
在一些实施例中,提供了包括单臂1120的盖主体。可选地,臂1120包括管状形状。在一些实施例中,狭缝1101沿着臂1120的中心纵向轴线设置,可选地沿着臂1120的整个长度延伸。可能地,狭缝1101对臂1120提供弹性,使得当施加力时能够打开1120的宽度。在一些实施例中,咬边1132被设置在臂1120的顶部槛的内周的至少一部分中。可选地咬边1132的尺寸和形状被设置成允许相对容易地插入抵靠表面,以及可能由于其卡扣启用,相对难以移除。在一些实施例中,孔1133被设置成为包含在注射器中的特征留出空间,这可能妨碍可用于臂1120的空间。
如本文所用,术语“约”是指±25%。
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/或部件,但仅指附加成分、步骤和/或部件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。
贯穿本申请,本发明的各种实施例可以以范围格式呈现。应该理解的是,范围形式的描述仅仅是为了方便和简洁,并且不应该被解释为对本发明范围的不灵活的限制。因此,范围的描述应被视为具体公开了所有可能的子范围以及该范围内的单个数值。例如,从1到6的范围的描述应该被认为具有特定公开的子范围,例如从1到3、1到4、1到5、2到4、2到6、3至6等,以及该范围内的单独数字,例如1、2、3、4、5和6。无论范围的宽度如何,这都适用。
无论何时本文指出的数字范围,其意图包括在所指示的范围内的任何引用的数字(分数或整数)。第一指示数字和第二指示数字之间的“范围/范围之间”和“范围/范围从”第一指示数字“到”第二指示数字在本文中可互换使用,并且意在包括第一和第二指示数字以及它们之间的所有分数和整数数字。
如本文所使用的,术语“方法”是指用于完成给定任务的方式、手段、技术和程序,包括但不限于由化学、药理学、生物学、生物化学和医学领域的从业人员已知或易于从已知方式、手段、技术和程序开发的那些方式、手段、技术和程序。
如本文所用,术语“治疗”包括消除、基本上抑制、减缓或逆转病症的进展,基本上改善病症的临床或美学症状或基本上防止出现病症的临床或美学症状。
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必要特征。
虽然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地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 (23)
1.一种用于移除针帽的装置,所述针帽用于防护注射器系统的针,其特征在于,所述装置包括:
盖体,所述盖体包括细长中空主体,所述细长中空主体具有尺寸和形状设置成至少部分地包络所述针帽的远端,
所述细长中空主体限定了近端部分,沿纵向轴线与所述近端部分相对的远端部分,以及从所述近端部分延伸至所述远端部分的基本圆柱形通道,所述远端部分包括至少一个卡扣,以及所述细长中空主体包括位于所述近端部分上的至少一个紧固件,所述紧固件限定了突出部,
所述细长中空主体具有闭合构造和打开构造,其中所述闭合构造由所述至少一个卡扣限定,所述至少一个卡扣限定比所述针帽的顶部槛的宽度小的宽度,并且所述打开构造由所述至少一个卡扣限定,所述至少一个卡扣具有足够宽的宽度以至少适合所述顶部槛的宽度;以及
连接器,所述连接器被配置为接收所述细长中空主体的所述近端部分,所述连接器限定了沿所述纵向轴线延伸的环形壁,其中所述紧固件被配置为接合所述环形壁的不同圆周部分,从而将所述盖体固定到所述连接器上,
其中处于所述闭合构造的所述细长中空主体的形状设置为保持所述至少一个卡扣悬伸在所述针帽的所述顶部槛上,其中所述细长中空主体包围所述针帽的下部部分,以及
其中,所述盖体比所述连接器的整体进一步向远端延伸。
2.如权利要求1所述的装置,其特征在于,所述至少一个卡扣朝向所述针帽的中心轴线弯曲,相对于所述轴线成角度。
3.根据权利要求1-2中任一项所述的装置,其特征在于,包括至少两个卡扣,所述至少两个卡扣联接到至少两个相应元件,所述至少两个卡扣是至少两个弹性臂,所述至少两个弹性臂具有打开构造,所述打开构造通过从所述针帽的中心轴线弹性偏离而限定,以及其中一旦所述至少两个卡扣被推到所述针帽的顶部槛以外,所述弹性臂返回到它们的闭合构造并且所述至少两个卡扣悬伸于所述针帽的顶部槛上。
4.根据权利要求3所述的装置,其特征在于,所述至少两个弹性臂中的每一个被限定为两个狭缝之间的表面,所述两个狭缝从所述细长中空主体的远端延伸。
5.根据权利要求4所述的装置,其特征在于,所述狭缝延伸至一长度,该长度具有所述细长中空主体的长度的20%到60%之间的范围。
6.根据权利要求4所述的装置,其特征在于,所述两个狭缝中的每一个具有0.5mm至1.5mm范围内的宽度。
7.根据权利要求4所述的装置,其特征在于,还包括设置在所述两个狭缝之间的所述表面中的至少一个中间纵向狭缝。
8.根据权利要求3所述的装置,其特征在于,所述至少两个弹性臂总计包围所述细长中空主体的周长的不超过40%。
9.根据权利要求8所述的装置,其特征在于,所述至少两个弹性臂围绕所述细长中空主体的圆周对称地定位。
10.根据权利要求1所述的装置,其特征在于,所述细长中空主体配置成使用50g和200g范围间的力推到所述针帽上。
11.根据权利要求1所述的装置,其特征在于,所述细长中空主体还包括至少两个沿其内表面的引导件,并且所述至少两个引导件沿着所述细长中空主体的纵向轴线定向,所述至少两个引导件的尺寸和形状设置成容纳定位在所述针帽的外表面上的互补元件。
12.根据权利要求1所述的装置,其特征在于,所述连接器包括具有突出元件的用户手柄。
13.根据权利要求12所述的装置,其特征在于,所述紧固件与所述环形壁的所述接合抑制所述细长中空主体相对于所述连接器的横向移动。
14.一种用于药物输送的系统,其特征在于,包括:
药筒,所述药筒容纳药物并与针流体连通,所述针由针帽包围;
壳体,所述壳体用于容纳所述药筒并具有用于允许进入所述针帽及其相关针的孔口;以及
根据权利要求3所述的用于移除针帽的装置,其中,所述至少两个卡扣限定了小于所述针帽的所述顶部槛的宽度的无应力宽度,以及
其中所述至少两个卡扣悬伸于所述针帽的所述顶部槛上,并且当所述弹性臂的近端被拉动时,所述卡扣使所述针帽与所述用于移除针帽的装置一起拉动。
15.根据权利要求14所述的系统,其特征在于,所述至少两个卡扣中的每一个包括朝向所述针帽的中心轴线弯曲并且朝向所述针帽的顶表面成角度的两个钩。
16.根据权利要求15所述的系统,其特征在于,所述钩围绕所述针帽的所述顶部槛的中心轴线对称地布置。
17.根据权利要求15-16中任一项所述的系统,其特征在于,所述用于移除针帽的装置包括所述至少两个臂中的两个,并且其中所述两个臂中的每一个包括所述钩中的两个。
18.根据权利要求14所述的系统,其特征在于,还包括具有保护衬垫的粘合层,所述粘合层连接到所述壳体,其中所述保护衬垫延伸超出所述壳体的表面并且位于所述用于移除针帽的装置的所述细长中空主体和所述连接器之间。
19.根据权利要求18的所述系统,其特征在于,当所述用于移除针帽的装置被线性拉动时,所述保护衬垫从所述壳体上被剥离。
20.根据权利要求14所述的系统,其特征在于,拉动所述细长中空主体和包围所述针的所述针帽至多需要不超过1kg的力。
21.一种将权利要求3的所述装置组装到针帽上的方法,其特征在于,包括:
将所述装置的所述细长中空主体的纵向轴线与所述针帽的纵向轴线对准共线;
将所述细长中空主体的远端沿着所述针帽的顶部的方向插入,同时使所述细长中空主体的所述至少两个弹性臂沿远离所述针帽的中心轴线的方向偏离,所述偏离通过联接到所述弹性臂的远端并限定比所述针帽的周长更小的周长的多个钩来提供,
其中提供所述插入直到所述多个钩延伸超过所述针帽的所述顶部并且朝向所述针帽的所述中心轴线向内卡合,从而悬伸于所述针帽的所述顶部,导致所述弹性臂从所述偏离朝向所述针帽的中心轴线卡合。
22.根据权利要求21所述的方法,其特征在于,所述针帽包含在注射器系统内,并且所述方法还包括将所述用于移除针帽的装置插过所述注射器系统中的可进入所述针帽的孔口。
23.根据权利要求21-22中任一项所述的方法,其特征在于,还包括将所述细长中空主体与电池隔离器相关联。
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CN108472438A (zh) | 2018-08-31 |
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CN113648488B (zh) | 2024-03-29 |
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CN113648488A (zh) | 2021-11-16 |
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JP7017512B2 (ja) | 2022-02-08 |
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US20220273879A1 (en) | 2022-09-01 |
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CN108472438B (zh) | 2022-01-28 |
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