CN113648488A - 至预填充的流体储存器的弯曲流体路径附加装置 - Google Patents
至预填充的流体储存器的弯曲流体路径附加装置 Download PDFInfo
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- CN113648488A CN113648488A CN202111088434.8A CN202111088434A CN113648488A CN 113648488 A CN113648488 A CN 113648488A CN 202111088434 A CN202111088434 A CN 202111088434A CN 113648488 A CN113648488 A CN 113648488A
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Abstract
一种用于自注射器的附加装置包括适配器。该适配器包括至少一个联接器和弯曲的流体路径。联接器的尺寸和形状设计成将适配器联接到流体储存器,弯曲的流体路径在第一端构造为穿透组织并且在第二端联接至适配器。联接到流体储存器的附加装置形成一体式自注射器药筒单元,自注射器药筒单元被构造为无菌且注入有注射剂。该适配器被构造成能将多个具有不同尺寸和尖端类型的储存器的至少一个联接到自注射器。
Description
本申请是申请日为2016年10月10日、申请号为“201680072280.4”、名称为“至预填充的流体储存器的弯曲流体路径附加装置”的专利申请的分案申请。
技术领域和背景技术
本发明在一些实施例中涉及一种自注射器(self-injector),更具体地但非排他地涉及贴片式自注射器。
皮下(SC)注射是一种在皮肤下施用药物的方法,通常进入皮肤和肌肉之间的脂肪组织。目前生物制剂的皮下注射趋势使得使用者能够在家自注射,其使用诸如可重复使用的和一次性的笔、自动注射器和粘附在皮肤表面的贴剂注射器的皮下注射生物制品的自动注射器。
在许多情况下,重新配制的药物可能更浓,有时更粘稠并且所需的注射容积大于1mL。对于高粘度产品,在10秒内输送可导致注射疼痛,这可能导致使用者不遵循其治疗方案。对于使用者而言,在持续超过10秒或几分钟的注射期间,很难保持笔或其他直立式注射器静止并位于注射的正确角度。因此,用于自执行SC注射的贴剂自动注射器或自注射器正变得越来越普遍。
另外的背景技术包括专利号为6,843,782和专利号为5,858,001的美国专利。
发明内容
根据本发明一些实施例的一个方面,提供一种包括适配器的自注射器附加装置,适配器包括至少一个联接件和弯曲的流体路径,所述联接件的尺寸和形状设计成将适配器联接到流体储存器,所述的弯曲流体路径构造成在第一端穿透组织并在第二端联接到适配器,其中联接到流体储存器的附件形成一体式自注射器药筒单元,其构造为无菌且注入有注射剂(injectable)。
根据本发明的一些实施例,所述的附加装置包括针体保护帽。根据一些实施例,流体路径以90度角弯曲。根据一些实施例,附加装置还包括至少一个紧固件,其尺寸设计成并安装成用于将储存器的本体联接到自注射器。
根据本发明的一些实施例的一个方面,提供了一种用于自注射器的附加装置,该附加装置包括适配器,该适配器包括至少一个联接器,所述联接其的形状和尺寸设置成将所述适配器联接到流体储存器,弯曲的流体路径构造成在第一端部处穿透组织并且在第二端部处联接到所述适配器,并且其中当所述附加装置联接到所述流体储存器时,在储存器和弯曲的流体路径的第一端之间建立无菌流体连通。根据本发明的一些实施例,弯曲的流体路径包括在第二端处的联接件,其尺寸和形状设计成将弯曲的流体路径联接到适配器并且固定两者之间无菌的流体连通。根据本发明的一些实施例,附加装置还包括至少一个紧固件,其尺寸设计成并安装来用于将储存器的本体连接到自注射器。根据本发明的一些实施例,弯曲的流体路径包括中空针体。根据本发明的一些实施例,流体路径以90度角弯曲。
根据本发明的一些实施例,储存器是预填充药盒。根据本发明的一些实施例,储存器是注射筒。根据本发明的一些实施例,储存器是药水瓶。根据本发明的一些实施例,储存器的至少一部分由玻璃制成。根据本发明的一些实施例,储存器的至少一部分由塑料材料制成。根据本发明的一些实施例,附加装置可整体消毒。根据本发明的一些实施例,适配器联接器是鲁尔锁联接器。根据本发明的一些实施例,适配器联接器是药水瓶适配器。根据本发明的一些实施例,适配器联接器是滑动流体储液器联接器。根据本发明的一些实施例,适配器还包括联接件,其尺寸和形状被设计成将附加件联接到自注射器。
根据本发明的一些实施例的一个方面,提供了一种用于自注射器的附加装置,其包括至少一个适配器以及至少一个紧固件,该适配器包括至少一个弯曲的流体路径并且尺寸设计成并安装来用于无菌地将弯曲的流体路径联接到流体储存器的尖端,所述紧固件的尺寸设计成并安装至所述流体储存器的所述自注射器的本体,并且其中所述适配器和所述紧固件被配置为联接具有不同尺寸和尖端类型的多种储存器的至少一种的自注射器。
根据本发明的一些实施例,适配器与紧固件之间的距离是可调整的。根据本发明的一些实施例,紧固件的内径是可调整的。根据本发明的一些实施例,附加装置还包括尺寸和形状设计成沿沿紧固件的内周部安装的配件。根据本发明的一些实施例,配件减小了紧固件的内径。根据本发明的一些实施例,紧固件的至少一部分由塑料材料制成。根据本发明的一些实施例,流体储存器的至少一部分由玻璃制成。根据本发明的一些实施例,流体储存器的至少一部分由塑料材料制成。根据本发明的一些实施例,弯曲的流体路径包括中空针体。根据本发明的一些实施例,流体路径以90度角弯曲。
根据本发明的一些实施例,储存器是预填充药盒。根据本发明的一些实施例,储存器是流体储存器。根据本发明的一些实施例,储存器是药水瓶。根据本发明的一些实施例,附加装置可整体消毒。根据本发明的一些实施例,适配器联接器是鲁尔锁联接器。根据本发明的一些实施例,适配器联接器是药水瓶适配器。根据本发明的一些实施例,适配器联接器是滑动流体储液器联接器。根据本发明的一些实施例,适配器还包括联接件,其尺寸和形状被设计成将附加件联接到自注射器。
根据本发明的一些实施例的一个方面,提供了一种附加自注射器联接系统的附加装置,其包括自注射器、至少一个适配器和至少一个紧固件,所述自注射器包括具有多个附接点的支撑板,适配器包括至少一个弯曲的流体路径且尺寸设计成并安装来用于无菌地将弯曲的流体路径联接到流体储存器的至少一个尖端,紧固件的尺寸设计成并安装来用于联接到流体储存器的本体和联接到附接点中的至少一个。
根据本发明的一些实施例,适配器的尺寸设计成和安装来用于联接到至少一个附接点。根据本发明的一些实施例,附接点以距离适配器不同的距离分布在支撑板上。根据本发明的一些实施例,不同的距离对应于不同长度的流体储存器。根据本发明的一些实施例,紧固件的内径是可调节的。根据本发明的一些实施例,系统还包括尺寸和形状设计成沿沿紧固件的内周部安装的配件。根据本发明的一些实施例,配件减小了紧固件的内径。
根据本发明的一些实施例的一个方面,提供了一种自注射器套装,包括至少一个自注射器、多个适配器和多个紧固件,所述自注射器包括具有多个附接点的支撑板,适配器包括至少一个弯曲的流体路径且尺寸设计成并安装来用于无菌地将弯曲的流体路径联接到流体储存器的至少一个类型的至少一个尖端,紧固件尺寸设计成并安装以联接到至少一个直径的流体储存器的本体和联接到附接点中的至少一个。
根据本发明的一些实施例,根据权利要求45所述的套件,其中还包括至少一个配件,其尺寸和形状设计成沿多个紧固件的至少一个的内周部安装。根据本发明的一些实施例,配件减小了紧固件的内径。根据本发明的一些实施例,流体储存器是至少一个预填充药筒、注射筒和药水瓶的至少一个。根据本发明的一些实施例,流体储存器的至少一部分由玻璃制成。根据本发明的一些实施例,紧固件的至少一部分由塑料材料制成。根据本发明的一些实施例,至少一个适配器是无菌的。
根据本发明的一些实施例的一个方面,提供了一种组装用于自注射器的附加装置的方法,包括:选择空流体储存器,通过将至少一个自注射器药筒单元的尖端联接到包括至少一个弯曲流体路径的适配器从而形成自注射器药筒单元,所述适配器的尺寸设计成并安装来用于将弯曲流体路径流体地联接至流体储存器的至少一个尖端并在流体储存器与弯曲流体路径之间建立流体连通。
根据本发明的一些实施例,该方法进一步包括消毒药筒,用无菌注射剂注入流体储器,将活塞插入流体储器的非弯曲流体路径端并且无菌密封流体储器的端部。根据本发明的一些实施例,该方法还包括选择至少一个紧固件并且将紧固件联接到流体储存器的本体并且将紧固件联接到注射器的至少一个对应的附接点。
根据本发明的一些实施例的一个方面,提供了一种将用于自注射器的附加装置联接到流体储存器的方法,该方法包括:选择流体储存器,将流体储存器的至少一个尖端联接到适配器,适配器包括至少一个弯曲的流体路径并且尺寸设计成并安装成将弯曲的流体路径流体地联接到流体储存器的至少一个尖端并且在流体储存器和弯曲的流体路径之间建立无菌连通。
根据本发明的一些实施例,该方法还包括选择至少一个紧固件并且将紧固件联接到流体储存器的本体并且将紧固件联接到注射器的至少一个对应的附接点。
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书。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
这里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而言,利用附图所作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是贴片式自注射器的侧视简易视图;
图2A、2B是对模块化贴片式自注射器的可选示例性实施例的侧视简化图;
图3A-3P是注射器-流体储存器联接器的示例性实施例的截面图和透视图的简化图;
图4A-4H是模块化流体储存器-注射器联接系统的示例性实施例的平面图和透视图的简化图;
图5A、5B、5C、5D、5E、5F和5G是示出紧固件定位的部分截面侧视图简图;以及
图6是用于自注射的家用套件的平面图简图。
具体实施方式
本发明在一些实施例中涉及一种自注射器,更具体地但非排他地涉及贴片式自注射器。
本发明的一些实施例的一个方面涉及一种自注射器,该自注射器尺寸设计成并安装以将具有不同尺寸和尖端类型的流体储存器联接到注射器。在一些实施例中,自注射器包括至少一个针体支承部分和至少一个紧固件,紧固件可连接至注射器并且至少连接至流体储存器的筒体。在一些实施例中,针体支撑部分包括针体保护盖。在一些实施例中,自注射器和流体储存器被无菌提供。例如,储存器、针体支承部分和盖帽可以组装在一起并一起消毒。在一些实施例中,自注射器和流体储存器被非无菌提供。在一些实施例中,自注射器和流体储存器在注入注射剂之前被消毒。在一些实施例中,灭菌后的无菌流体储存器注入有注射剂,并提供无菌密封并盖上保护帽。在一些实施例中,针体支撑部分和紧固件之间的距离是可调整的。在一些实施例例,紧固件的内半径是可调整的。在一些实施例中,该注射器包括贴片型自注射器。在一些实施例中,注射器包括弯曲的针体。在一些实施例中,针体以90度角弯曲。在一些实施例中,注射器的至少一部分包括至少一个孔,其尺寸设计成并安装以容纳流体储存器尖端。在一些实施例中,针体的至少一部分穿过孔延伸。在一些实施例中,针体支撑部分固定在位。在一些实施例中,流体储存器包括注射筒。在一些实施例中,流体储存器包括药水瓶。在一些实施例中,流体储存器包括药筒。
在一些实施例中,自注射器的尺寸设计成并安装以容纳可再填充的流体储存器。在一些实施例中,自注射器的尺寸设计成并安装以容纳预填充的流体储存器。在一些实施例中,预填充流体储存器尖端被无菌密封。在一些实施例中,注射器包括将针连接至一个或多个流体储存器尖端类型的一个或多个适配器。在一些实施例中,适配器的尺寸设计成并安装来用于将针体联接到滑动式或推入式流体储存器尖端。在一些实施例中,适配器的尺寸设计成并安装来用于将针体连接到鲁尔锁(Luer-lock)流体储存器尖端。在一些实施例中,适配器的尺寸设计成并安装来用于将针体连接到导管型流体储存器尖端。在一些实施例中,适配器的尺寸设计成并安装来用于将针体连接到具有居中尖端的储存器。在一些实施例中,适配器的尺寸设计成并安装来用于将针体连接到具有离心尖端的储存器。
本发明的一些实施例的一个方面涉及自注射器,包括模块化流体储存器- 注射器联接系统。在一些实施例中,模块化系统包括支撑板,该支撑板的尺寸设计成并安装来以适应不同类型和尺寸的流体储存器。在一些实施例中,注射器包括弯曲的针体。在一些实施例中,针体以90度角弯曲。在一些实施例中,支撑板包括一个或多个凹口,凹口构造成容纳将流体储存器固定到注射器的紧固件。在一些实施例中,一个或多个紧固件的至少一部分固定地联接到自注射器支撑板。在一些实施例中,一个或多个紧固件的至少一部分可释放地联接到自注射器支撑板。在一些实施例中,一个或多个紧固件包括至少一个孔口,该孔口尺寸设计成并安装来容纳流体储存器尖端。在一些实施例中,至少一个紧固件包括弯曲针体。在一些实施例中,至少一个紧固件包括至少一个孔口,其尺寸设计成并安装来容纳流体储存器尖端。在一些实施例中,针体的至少一部分穿过孔或孔口延伸。
在一些实施例中,至少一个紧固件包括锁舌和铰链。在一些实施例中,至少一个紧固件包括一个或多个锁舌。在一些实施例中,至少一个紧固件的尺寸被设计成并安装以紧固流体储存器的筒体。在一些实施例中,至少一个紧固件的尺寸被设计成并安装以紧固流体储存器的棘爪凸缘。在一些实施例中,至少一个紧固件包括至少一个配件,其尺寸设计成并安装来用于特定流体储存器筒体直径。在一些实施例中,至少一个紧固件配备有至少部分有弹性的垫。在一些实施例中,当锁定在注射器中的位置时,流体储存器的至少一部分被推靠在弹性垫上。在一些实施例中,弹性垫阻止流体储存器尖端-针体联接处的泄漏。在一些实施例中,弹性垫包括用于针体尖端的孔。
本发明的一些实施例的一个方面涉及一种自注射器,其包括弯曲的针体并具有鲁尔锁(Luer-lock)联接器,其尺寸设计成并安装以接纳具有公鲁尔锁型尖端的流体储存器。在一些实施例中,鲁尔锁联接器包括圆柱体,圆柱体的一端连接到注射器并且包括配置成入拧入公鲁尔锁流体储存器尖端中的突片边缘。在一些实施例中,弯曲针体的至少一部分设置在圆柱体的内腔中。在一些实施例中,针体的至少一部分附接到圆柱体的内壁。在一些实施例中,针体的一部分和内壁之间的圆柱腔的至少一部分包括密封件。在一些实施例中,弯曲针体的至少一端延伸超过圆柱形突片边缘。在一些实施例中,延伸超过圆柱形突片边缘的弯曲针体的端部包括保护套。在一些实施例中,保护套保持针体端部的无菌性。在一些实施例中,保护套保持圆柱腔内针体的部分无菌直至并且包括延伸超过突出边缘的针体的端部。在一些实施例中,在联接时,公鲁尔锁的边缘将保护套推靠在针体的尖端上。在一些实施例中,针体的尖端通过公鲁尔锁定边缘破坏推向针尖的保护套。
本发明的一些实施例的一个方面涉及一种自注射器,其尺寸涉及成并安装以无菌地容纳不同类型和尺寸的流体储存器。在一些实施例中,自注射器包括联接器,该联接器在连接到含有注射剂的流体储存器期间和之后保持注射剂通路的无菌性。在一些实施例中,注射器联接件包括针体一端至少部分地被至少一个保护性护套隔开。在一些实施例中,在联接期间,联接的流体储存器的尖端推动至少一个护套抵靠针体端部破坏护套。在一些实施例中,联接的流体储存器的尖端包括在尖端开口上方的密封膜。在一些实施例中,在连接期间,注射器针体被推靠在膜上并穿透流体储存器尖端。
本发明的一些实施例的一个方面涉及一种自注射器套件,其包括支撑板和多个紧固件和配件,其尺寸设计成并安装以附接到支撑板。在一些实施例中,所述多个紧固件和配件的尺寸设计成并安装以无菌地容纳不同类型和尺寸的流体储存器。在一些实施例中,多个紧固件包括快速附接型联接件。在一些实施例中,所述多个紧固件包括至少一个一键式联接器。在一些实施例中,可以联接各种紧固件在各种期望的位置的支撑位置。在一些实施例中,至少一个紧固件包括弯曲针体。在一些实施例中,一个或多个紧固件构造成容纳至少一个配件。在一些实施例中,一个或多个紧固件和/或配件包括不同内径的一个或多个孔以配合至少一个流体储存器的至少一个筒体和/或棘爪凸缘。
本发明的一些实施例的一个方面涉及一种将不同类型和尺寸的流体储存器装载到自注射器的方法。在一些实施例中,该方法包括一个或多个紧固件,其尺寸设计成并安装来用于所选流体储存器的筒体和棘爪凸缘。在一些实施例中,该方法可选地包括选择至少一个配件,其尺寸设计成并安装来用于所选的流体储存器的筒体和棘爪凸缘。在一些实施例中,该方法还包括可选地将一个或多个配件滑动或联接到流体储存器的筒体或棘爪凸缘。在一些实施例中,该方法还包括将一个或多个紧固件滑动或联接到流体储存器的筒体或棘爪凸缘。在一些实施例中,该方法还包括将流体储存器的尖端插入到注射器的针体部分的孔口中。在一些实施例中,该方法还包括可选地将流体储存器的尖端插入到针头支撑紧固件的孔中。在一些实施例中,该方法还包括将紧固件连接到支撑板。在一些实施例中,该方法还包括将流体储存器连接到注射器流体贮存器柱塞驱动系统。
介绍
现在参考图1,其为贴片型自注射器的侧视图简图,如在申请号为 62/284,806的美国临时专利申请中所描述的,并且因此整体引入。自注射器 100包括弯曲的针体102,例如,以90度的角度弯曲连接至药筒104。药筒104 可以预注入注射剂。药盒104可以安装在支撑板106上并且包括由电动机驱动齿轮110驱动的柱塞108。在注射程序之后,药筒104可被丢弃并由新的预填充药筒代替。
注射器动力总成和柱塞驱动系统在上面引用的申请号为62/284,806的美国临时专利申请中有详细说明,因此在此不再赘述。
模块自注射器流体储存器连接系统的可选组件
现在参考图2A、2B(统称为图2),是对模块化贴片型自注射器的可选示例性实施例的侧视简化图。如图2所示,自注射器200尺寸设置为并安装为可以适应各种类型和尺寸的流体储存器。如在图1的示例中,在一些实施例中,自注射器200包括弯曲的针体202,例如以90度角弯曲。如在本公开其他部分更详细解释的,在一些实施例中,自注射器200包括支撑板204和至少一个针体202支承部分206。在一些实施例中,针体支撑部分206包括至少一个孔208,该孔的尺寸设计成并安装成容纳流体储存器250/255的尖端252。在一些实施例中,孔208包括通向针体202的弯曲部分212的孔口210。在一些实施例中,针体202的至少一部分紧密地穿过孔口210延伸并延伸入孔208。在一些实施例中,针体支撑部分206被固定在支撑板204上。
在一些实施例中,如图2A所示,孔208偏心地设置在针体支撑部分206 内以容纳偏心尖端流体储存器。在一些实施例中,如图2B所示,孔208居中设置在针体支撑部分206内以容纳规则(中心的)尖端流体储存器。
注射器流体储存器连接器的可选示例
常用的流体储存器尖端包括滑动式或推动式尖端和鲁尔锁式尖端。塑料流体储存器包含两种类型的塑料尖端,而玻璃流体储存器尖端通常由金属制成。一些玻璃流体储存器包括玻璃滑动式尖端。常用的流体储液器-针体连接实践试图保持无菌的可注射通道,但是这有时可能是有挑战性的。通常的做法是将流体储存器和针体都分别储存在无菌袋中,以限制从袋中取出的时刻到注射时刻的暴露于外界的时间。当涉及到自注射器,特别是贴片式自注射器时,这种做法是不实际的。
滑动式/推入式
现在参考图3A-3P(统称为图3),其是注射器-流体储存器联接器的示例性实施例的截面图和透视图的简化图。图3A-3L的示例性实施例描绘了将针体 202连接到一个或多个不同流体储存器尖端类型的一个或多个适配器。例如,图3A示出了针体支撑部分206,其包括适配器302,该适配器302的尺寸被设计成并安装成将针体202连接到滑动式或推入式流体储存器尖端352。设置在中央的孔308在一侧朝面向流体储存器的开口306开设以接收流体储存器尖端并且在相对侧上在孔口310处结束,孔口310设计成密封地容纳针体202的至少一部分。可选地,在一些实施例中,孔308包括锥形几何形状。在一些实施例中,孔308包括圆柱几何形状。可选地并且也如图3C所示,在一些实施例中,针体支撑部分206还可包括弹性配件312,弹性配件312粘附或通过任何其他合适的方法覆盖在开口306上。在一些实施例中,配件312可以包括孔口 314,该孔口的尺寸被设计成容纳相应尺寸的滑动式流体储存器尖端。在一些实施例中,当将流体储存器350的至少一部分在被锁定到注射器中的适当位置同时抵靠弹性配件时,弹性配件312阻止流体储存器针尖-针体连接泄漏的可能性。
在一些实施例中,如图3B所示,配件312可由弹性类型的合适材料(例如,硅酮)制成,以在流体储存器筒体352被抵靠在针体支撑部分206上时充当密封件并密封件开口306。
如图3A和3B所示,在一些实施例中,当流体储存器350连接到自注射器时,针体316的端部可至少部分地延伸到孔308中并进入流体储存器尖端354 的内腔。如图3D和3E所示,流体储存器350的尖端可被密封以便消毒。例如,流体储存器尖端356(图3D)的开口可以由膜358密封,或者可选地,流体储存器尖端360(图3E)可以被保护性护套362覆盖。在一些实施例中,联接到流体储存器350时,延伸至孔308中的针体202的端部316被配置为破坏用于保护流体储存器350内部的注射剂无菌性的大部分类型的流体储存器尖端密封件。在一些实施例中,并且在图3F中示出,配件312孔径314可以由膜状密封件320密封。在一些实施例中,当自注射器200连接到流体储存器350时,流体储存器350的尖端356/360可破坏膜状密封件320。
鲁尔锁式(Luer-lock type)
现参照3G-3I,其示出了自注射器200,自注射器200包括弯曲针体202 和鲁尔锁联接件316,其尺寸设计成并安装来以容纳具有公鲁尔锁式尖端362 的流体储存器350。在一些实施例中,鲁尔锁联接件316包括圆柱体,圆柱体在一端密封地连接到针体202和注射器200,并且圆柱体包括在相对端的突片边缘322,突片边缘322朝向孔308的开口306开口。在一些实施例中,突片边缘322被配置成拧入鲁尔锁流体储存器尖端362上的套筒364。图3I示出处于完全配合构造的鲁尔锁联接件316和鲁尔锁式流体储存器350尖端362。
图3J-3L描绘的实施例示出了类似于本公开其他部分所描述的鲁尔锁联接器系统。可选地,在一些实施例中并且如图3J所示,延伸超出鲁尔锁联接件 316的突片边缘322的弯曲针体202的端部324包括保护性护套318,保护性护套318构造成保持针体端部324无菌。在一些实施例中,保护性护套318由易弯曲的膜状材料制成,例如橡胶、聚氨酯或任何其他合适的材料。在一些实施例中,当如图3K所示配合时,鲁尔锁流体储存器350尖端362的边缘366 推动保护套318抵靠针体端部324。在一些实施例中并且如图3K所示,针体端部324在进入流体储存器鲁尔锁尖端362的内腔368时破坏保护性护套318。图3L示出处于完全配合构造的鲁尔锁定联接件316和鲁尔锁式流体储存器350 尖端362。另外并且可选地,在一些实施例中,流体储存器公鲁尔锁尖端316 包括密封件,其类似于流体储存器尖端356的密封件358。
在一些实施例中,如图3M和3N所示,自注射器可以包括弯曲的针体适配器370,其包括流体储存器联接件和第二联接件375,流体储存器联接件类似于本公开中其他部分所述的示例,第二联接件375位于适配器370的第二端部。在图3M和3N示例中描述的第二联接器375包括鲁尔锁尖端。盖377保护第二联接器375免受外界影响并维持针体适配器370的无菌性。在一些实施例中,适配器370提供将标准针体379连接到自注射器200的自由度。在图3N所示的示例性实施例中,保护帽377已被移除并且鲁尔锁尖端针体379联接到针体适配器370和流体储存器350上。
如图3O和3P所示,弯曲针体适配器376的示例性实施例包括药水瓶适配器357,例如申请号为7,326,194的美国专利中描述的蒙达蒙普医疗项目公司(Medimop MedicalProjects Ltd.)的药水瓶适配器。在一些实施例中,弯曲的针体适配器376包括无菌盖359。在一些实施例中,弯曲针体适配器376 包括针体帽377。可选地和替代地并且如图3P所示,弯曲的针体适配器376可以连接到空的药水瓶378上以形成单独的非无菌的自注射器药盒单元365。在一些实施例中,药盒单元365然后可以被消毒并且注入有注射剂。
紧固件和配件的可选示例
本发明的一些实施例的一个方面涉及自注射器,其包括模块化流体储存器 -注射器联接系统。自注射器和专门的贴片自注射器设计成在注射过程中避免注射针在组织中的移动,从而最大程度地减少与注射相关的疼痛。这通过将注射针和/或流体储存器药盒固定连接到自注射器壳体的各种联接方法来实现。
现在参考图4A-4H(统称为图4),其是模块化流体储存器-注射器联接系统的示例性实施例的平面图和透视图的简化图。在图4所示的示例中,自注射器200包括一个或多个紧固件402,其尺寸设计成并安装来容纳流体储存器450 的至少一个筒体452或棘爪凸缘454。在一些实施例中,如图4A和4B所示,注射器200包括一个或多个紧固件,其被配置为将变化类型和尺寸的流体储存器连接到自注射器200。如图4A所示,在一些实施例中,紧固件404包括环形几何形状,其尺寸设计成和安装以滑动到相应直径的流体储存器筒体上。在一些实施例中,紧固件404还包括从紧固件404的周部延伸的至少一个突起406。在图4A所示的示例性实施例中,突起406从紧固件404的环部切向延伸,然而突起406可以径向或以任何其他合适的几何构造延伸。在一些实施例中,突起406至少平行于支撑板410的表面408取向。在图4A所示的示例性实施例中,至少一个突起406通过至少一个助留构件固定地联接到支撑板410。在图 4A所示的示例中,附接构件包括保持悬臂412。在一些实施例中,保持悬臂412 是弹性的和/或包括联接至支撑板410的至少一个弹性联接件。然而,附接构件可以包括任何类型的合适的附接机构。在一些实施例中,保持悬臂412被配置为将紧固件404突起406可释放地联接到支撑板。图4B和图4C示出了示例的实施例,其中紧固件414包括倒U形几何形状。在一些实施例中,支撑板410 具有构造成容纳紧固件414的腿部418的多个凹口416。在一些实施例中,支撑板410的凹口416包括保持悬臂420,保持悬臂420构造成通过安装入腿部 418中的一个或多个相应的凹槽422中而将紧固件414可释放地联接到支撑板。可选地,多个凹槽422通过调节紧固件414的一个或多个腿部418插入支撑板 410的深度来支持紧固件414的内部半径的调节。因此,多个凹槽422使紧固件414构造成具有安装各种流体储存器的尺寸。
如图4D所示,在一些实施例中,支撑板410包括多个附接点412/416,多个附接点412/416分布成允许紧固件402/414/424以距离针体部分206不同的距离联接到支撑板410,以容纳不同长度的流体储存器。在一些实施例中,附接点412/416可选地包括图4A中所示类型的悬臂420。在一些实施例中,附接点412/416可选地包括凹口416和保持悬臂420,其被构造成将图4B和图4C 中所示类型的紧固件可释放地联接。在一些实施例中,附接点412/416可选地包括滑动铰链和保持臂,其处于图4E和4F所示的构型中。另外并且可选地,附接点412/416可以包括除了本文描述的示例性实施例之外的任何类似的合适附接机构。
图4E和4F示出了示例的实施例,其中紧固件424包括铰接的倒U形几何形状。在图4E和4F所示例子中,一腿部426包括滑动铰链428,滑动铰链428 构造成当打开时形成大间隙以释放或容纳流体储存器筒体452。在图4E所示的闭合构造中,紧固件424的非铰接腿部426通过保持悬臂420锁定在位。
在一些实施例中,紧固件402/414/424中的至少一个包括相同的尺寸以安装到相同的支撑板410上。在一些实施例中,如图4G和4H所示,紧固件 402/414/424装配有一个或多个不同直径的环形几何形状配件430(图4H),其尺寸设计成和配合特定流体储存筒体的相应直径。在一些实施例中,配件430 被构造成滑动到流体储存器450的筒体452上,并且当紧固件(例如弹簧紧固件414/424)处于闭合构型是提供充分的摩擦以防止流体储存器筒体452相对于支撑板410的轴向滑动和移动。
图4G和4H示出了4B和4C所示类型的紧固件,但是配件430可以装配在本文所述的任何一个紧固件中或任何其它类似类型的紧固件中。
适配器-流体储液器联接件和紧固件定位的可选示例
为了确保流体储存器与自注射器的固定连接,除了将流体储存器固定到诸如支撑板410的表面之外,需要调节诸如紧固件420/414/424的紧固件到流体储存器筒体的长度。在大多数情况下,这可以通过如本公开的其他部分所述的沿着流体储存器筒体滑动紧固件和/或将紧固件连接到流体储存器的棘爪凸缘来实现。在本公开内容的其他部分描述的模块化支撑板410的结构允许当被安装到流体储存器筒体或棘爪凸缘时将紧固件定位在几乎任何期望的位置处。现在参考图5A-5G,其为将流体储存器联接到自注射器的紧固件定位的部分截面侧视图简图。
在图5A所示的示例性实施例中,空的流体储存器590联接至针体支撑部分534以形成单个整体式自注射器药筒单元535。在一些实施例中,药筒单元 535是无菌的。在一些实施例中,药筒单元535是非无菌的。在一些实施例中,药筒单元535被消毒,以无菌方式注入注射剂并无菌、密封提供并准备使用。如图5B所示的示例性实施例所示,无菌预注入的药筒单元535通过一个或多个紧固件402(图4A)联接到支撑板410。在一些实施例中,药筒单元535包括柱塞570并且在无菌注入之后用密封件595密封。在一些实施例中,药筒单元535未消毒地输送以在包膜(例如塑料泡罩539)内消毒和填充。如图5C所示,包括滑动式尖端的流体储存器550(例如20cc流体储存器)安装到自注射器500上。在图5C所示的示例性实施例中,尖端502被示出为以本公开中其他部分描述的方式(不在赘述)插入到针体支撑部分506中。在图5C所示的示例性实施例中,针体支撑部分506包括类似于紧固件504联接器的联接器,并且可逆地联接到支撑板410。在一些实施例中,本公开中其他部分描述(不再赘述)的形式和功能的一个或多个紧固件504沿筒体452定位,其中至少一个紧靠联接流体储存器450的筒体452的棘爪凸缘454以支撑板410。在一些实施例中,当闭合时,紧固件504提供抵靠筒体452的足够摩擦,以防止筒体 452相对于支撑板410的轴向滑动和移动。可替换地和可选地,在一些实施例中,本公开中其他部分描述类型的配件可以装配在紧固件504内并且提供抵靠筒体452的足够摩擦,以防止筒体452相对于支撑板410的轴向滑动和移动。
替代地并且可选地并且如图5D所示,在一些实施例中,紧固件506包括沿着内壁510的径向狭槽508,其尺寸被设计成和安装成容纳相应尺寸的流体储存棘爪凸缘454。替代地并且可选地并且如图5E所示,在一些实施例中,紧固件504类型的紧固件包括安装在紧固件504内部的配件512,其包括沿配件 512的内壁的径向狭槽514,其尺寸被设计成并安装成容纳相应尺寸的流体储存器棘爪凸缘454。在一些实施例中,配件512提供抵靠棘爪凸缘454的足够摩擦,以防止筒体452相对于支撑板410的轴向滑动和移动。在图5D中,流体储存器柱塞已经被构造成由自注射器500柱塞驱动系统(未示出)驱动的柱塞570替代。
替换地并且可选地,图5F中示出了模块化流体储存器-注射器联接系统,其将小尺寸流体储存器555(例如5cc流体储存器)联接到自注射器500。流体储存器555的滑动式尖端被示出为以本公开中其他部分所述的方式(不再赘述)插入到针体支撑部分506中。在一些实施例中,本公开中其他部分描述(不再赘述)的形式和功能的一个或多个紧固件504沿筒体552定位,其中至少一个紧靠联接流体储存器555的筒体552的棘爪凸缘554以支撑板410。在一些实施例中,当闭合时,紧固件504提供抵靠筒体552的足够摩擦,以防止筒体 552相对于支撑板410的轴向滑动和移动。可替换地和可选地,在一些实施例中,本公开中其他部分描述类型的配件430可以装配在紧固件504内并且提供抵靠筒体552的足够摩擦,以防止筒体552相对于支撑板410的轴向滑动和移动。
在图5F所示的实施例中,安装在紧固件504内部的配件512的尺寸设计成并安装成适应对应尺寸的流体储存棘爪凸缘554。如图5G所示,针体支撑部分506包括联接件537以支撑板,联接件类似于紧固件504的联接件或本公开中其他部分所述的任何类型的紧固件联接件,并且可逆地联接到支撑板410。如图5G所示,在一些实施例中,无棘爪凸缘的流体储存器590密封地附接到针体支撑部分506。在图5G中描述的示例性实施例中,流体储存器590是预填充的药水瓶,其附接到针体支撑部分506并且装配有紧固件402(图4C)以安装到支撑板410上,如本公开其他部分中所解释的。在一些实施例中,针体支撑部分506包括针体202和保护帽377。在一些实施例中,流体储存器590用密封件595无菌密封。在一些实施例中,附接到针体支撑部分506的预填充流体储存器590被输送到诸如塑料泡罩539的包膜中。现在参考图6,其是用于自注射的家用套件的平面图简图。如图6所示,在一些实施例中,套件600包括图6中由模块化支撑板410、多个紧固件602和包括各种内径的各种配件604 表示的自注射器。
另外并且可选地,在一些实施例中,套件600可以包括标记,其帮助用户为相应的选定流体储存器选择正确的紧固件或配件。例如,在图6所示的示例性实施例中,对于选定的50cc流体储存器,使用者可以仅选择紧固件以将流体储存器充分地联接到自注射器。对于较小尺寸的流体储存器(例如10cc流体储存器),使用者可以选择将标记为“10cc”的紧固件和的配件插入紧固器中。在一些实施例中,套件600包括用于适配紧固件和配件的尺寸和类型的清楚标记的指示符(例如,“5cc”、“10cc”、“20cc”、“50cc”、“尖端”,“凸缘”等)。
在一些实施例中,使用者可使用套件600通过将自注射器从套件移除并打开盖以暴露支撑板410来将流体储存器联接至自注射器。在一些实施例中,该方法还包括将针体部分506联接到流体储存器。在一些实施例中,针体支撑部分506包括针体保护帽377。在一些实施例中,该方法还包括选择一个或多个紧固件602并将一个或多个紧固件滑动到流体储存器的筒体452/552上。可替换地并且可选地,该方法包括将一个或多个紧固件602联接到支撑板410。可选地,该方法包括在滑动到流体储存器的筒体452/552之前将一个或多个配件 604插入一个或多个紧固件602中。另外并且可选地,该方法包括选择棘爪凸缘紧固件606并且将流体储存器凸缘联接到支撑板410。可选地,该方法包括在将流体储存器凸缘联接到支撑板410之前将一个或多个棘爪凸缘配件608插入到一个或多个紧固件602中。可选地,该方法包括选择至少一个附接点 412/416并将紧固件604/606附接到所选附接点412/416。
术语“包括”,“包括有”,“包含”,“包含于”,“具有”及其结合的意思是“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。
在整个申请中,本发明的实施例可以参考范围形式来呈现。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,诸如“1至6”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”、“从1到4”、“从1到5”、“从2到4”、“从2至6”,“从3至6”等。以及该范围内的个别数字,例如1、2、3、4、 5和6。适用于所有范围的宽度。
本文中无论何时指示数字范围(例如“10-15”、“10至15”或由这些另一范围指示链接的任何一对数字),其旨在包括指示范围限制内的任何数字(分数或整数),包括范围限制,除非上下文另有明确规定。在本文中,第一指示数字和第二指示数字之间的“范围/排列/范围于”和从第一指示数“到”,“达到”,“直到”或“通过”(或另一个这样的范围指示术语)第二指示数字可互换地使用,并且旨在包括第一指示数字和第二指示数字以及其间的所有分数和整数。
除非另外指明,否则本文使用的数字和基于其的任何数字范围是本领域技术人员所理解的合理测量精确度和舍入误差内的近似值。
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。
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 (13)
1.一种用于自注射器的附加装置,其特征在于,包括:
适配器,所述适配器包括至少一个鲁尔锁联接器,所述联接器的尺寸和形状设计成将所述适配器联接到流体储存器;
刚性且弯曲的流体路径,所述刚性且弯曲的流体路径具有第一端和第二端,所述第一端构造成穿透组织,所述第二端连接至所述适配器;以及
其中,当所述附加装置联接到所述流体储存器,在所述流体储存器和所述弯曲的流体路径的所述第一端之间确保无菌流体连通。
2.根据权利要求1所述的附加装置,其特征在于,所述弯曲的流体路径包括在所述第二端处的联接器,所述联接器的尺寸和形状设计成将所述弯曲的流体路径联接到所述适配器并且固定两者之间无菌的流体连通。
3.根据权利要求1所述的附加装置,其特征在于,所述附加装置还包括至少一个紧固件,所述紧固件的尺寸设计成并安装来用于将所述储存器的本体联接到自注射器。
4.根据权利要求1所述的附加装置,其特征在于,所述的弯曲的流体路径包括空心的针体。
5.根据权利要求1所述的附加装置,其特征在于,所述的流体路径以90度角度弯曲。
6.根据权利要求1所述的附加装置,其特征在于,所述的储存器是预填充药筒。
7.根据权利要求1所述的附加装置,其特征在于,所述的储存器是注射筒。
8.根据权利要求1所述的附加装置,其特征在于,所述的储存器是药水瓶。
9.根据权利要求1所述的附加装置,其特征在于,所述的储存器的至少一部分由玻璃制成。
10.根据权利要求1所述的附加装置,其特征在于,所述的储存器的至少一部分由塑料材料制成。
11.根据权利要求1所述的附加装置,其特征在于,所述的储存器是可整体消毒的。
12.根据权利要求1所述的附加装置,其特征在于,所述的适配器的联接器是药水瓶适配器。
13.根据权利要求1所述的附加装置,其特征在于,所述的适配器还包括联接器,所述的联接器的尺寸和形状设计成将所述附加装置联接到自注射器。
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US20220273879A1 (en) | 2022-09-01 |
JP7044708B2 (ja) | 2022-03-30 |
JP2022002725A (ja) | 2022-01-11 |
JP7017512B2 (ja) | 2022-02-08 |
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CN112972833A (zh) | 2021-06-18 |
CN108472438A (zh) | 2018-08-31 |
CN108430536A (zh) | 2018-08-21 |
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CN112972833B (zh) | 2024-01-09 |
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