CN113181477A - 用于药物释放装置的筒插入 - Google Patents

用于药物释放装置的筒插入 Download PDF

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CN113181477A
CN113181477A CN202110536082.1A CN202110536082A CN113181477A CN 113181477 A CN113181477 A CN 113181477A CN 202110536082 A CN202110536082 A CN 202110536082A CN 113181477 A CN113181477 A CN 113181477A
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cartridge
compartment
optionally
reservoir
drug delivery
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约西·巴尔-埃尔
吉尔·伊格尔
鲁文·Y·费尔曼
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Mcgrady Medical Engineering Co ltd
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Abstract

公开了一种用于在药物筒与药物释放装置之间接口连接的方法和组件。可选地,药物释放装置包括在药物释放期间保持筒的隔室和/或安装到在隔室后方(靠近隔室)的装置的塞子推动组件。在一些实施例中,筒可以在推动组件的前方被横向地插入到隔室中。例如,释放装置可以包括移动筒舱。筒可选地被插入到舱中和/或舱和筒可选地被移动到筒隔室中。可选地或另外地,筒隔室可以具有筒被插入到其中的近端开口和/或推入组件可以在筒的插入之后被移动就位。在一些实施例中,筒可以具有通过纵向移动而被破坏的远端密封件。

Description

用于药物释放装置的筒插入
本申请是申请日为2016年6月3日,申请号为201680032632.3,发明名称为“用于药物释放装置的筒插入”的专利申请的分案申请。
技术领域
本发明在其一些实施例中涉及一种用于药物释放(delivery)装置的筒(cartridge)插入组件,并且更特别地但不排他地,涉及一种用于包括内部伸缩组件的药物装置的插入组件。
背景技术
专利号为6,800,071的美国专利公开了“一种改进的泵、储存器(reservoir)和储存器储存器活塞(piston)用于,”“受控制的流体的释放。马达可操作地联接到诸如驱动螺杆的驱动构件,该驱动构件适于响应于马达的操作而推进柱塞滑块(plunger slide)。柱塞滑块可移除地联接到活塞。活塞包括第一构件和第二构件。第一构件具有外部近端和外部远端。外部近端适于接触流体并且由具有第一刚度的材料制成。第二构件具有第一侧和第二侧,并且至少部分地设置在第一构件内。第二构件的第一侧与第一构件的外部近端相邻,并且由具有大于第一刚度的刚度的材料制成。”
卡比里(Cabiri)的公开号为2013/0253472的美国专利申请公开“一种方法和设备”......“用于向接受者释放药物。在一些实施例中,释放设备可以开封含药物的储存器。在一些实施例中,释放速率可以是受控制的和/或可调节的。可选地,设备可以是一次性的。可选地,设备可以具有较低的高度(low profile)和/或者是可穿戴的和/或可附接到接受者。可选地,药物的排出和/或储存器的开封可以由平行于设备的基部移动的柱塞驱动。可选地,设备可以将皮下注射针释放到接受者体内。可选地,可在与柱塞的移动方向不平行和/或正交的方向上释放皮下注射针。
可选地,在释放之前,皮下注射针可以通过密封针口的针口隔膜被保存在无菌状态下。可选地,在释放时,皮下注射针可以刺穿针口隔膜。”
另外的背景技术包括卡比里的公开号为WO/2011/090956的国际专利申请公开、格罗斯(Gross)的公开号为2009/0093792的美国专利申请公开、公开号为20130304021的美国专利申请公开、公开号为20130296799的美国专利申请公开、公开号为20130245596的美国专利申请公开、专利号为8465455的美国专利、公开号为WO/2011/090956的国际专利申请公开以及公开号为2009/0093792的美国专利申请公开。
通过伸缩组件致动的注射器(syringe)塞子(stoppers)的示例可以在例如卡比里的公开号为WO/2011/090956的国际专利申请公开和格罗斯的公开号为2009/0093792的美国专利申请公开中找到,其整体通过引用被并入本文。
发明内容
除非另有限定,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含义相同的含义。虽然与本文描述的相类似或等同的方法和材料可以被用于本发明的实施例的实践或测试中,但是下面描述示例性方法和/或材料。在冲突的情况下,包括定义的专利说明书将受到控制。另外,材料、方法和实施例仅是说明性的,并不旨在必要地限制。
根据本发明的一些实施例的方面,提供一种用于将圆柱形储存器连接到具有皮肤接触表面的药物释放装置的接口,接口包括:联接器,其独立于圆柱形储存器而附接到药物释放装置,该联接器被设定尺寸并成形以在圆柱形储存器的远端开口与药物释放装置的流体路径之间形成流动路径;扩展(expanding)组件,其独立于圆柱形储存器而被附接到药物释放装置并且沿着平行于皮肤接触表面的轴线扩展;隔室(compartment),其被成形并设定尺寸以容纳(hold)圆柱形储存器,其中圆柱形储存器的纵向轴线与扩展的轴线同轴并且圆柱形储存器的近端开口面向扩展组件并且储存器的远端开口面向联接器。根据本发明的一些实施例,联接器包括套管,该套管被设定尺寸并成形以用于刺穿储存器的远端开口的密封件。
根据本发明的一些实施例,接口进一步包括:通道,其被成形以用于引导储存器沿着通道朝向联接器纵向地移动,使得联接器刺穿储存器的远端开口的密封件。
根据本发明的一些实施例,通道处于隔室内部,接口进一步包括:通道的近端开口,其被设计尺寸并成形以用于将储存器的近端朝向联接器轴向插入到通道中;以及可移动支架(mount),其将扩展组件连接到释放装置,以用于在靠近通道的近端开口并且阻止将储存器插入到通道的近端开口中的第一位置与其中扩展组件远离通道的近端开口的第二位置之间移动。
根据本发明的一些实施例,接口进一步包括:舱(bay),其包括通道并且可移动地安装到释放装置以在装载位置和释放位置之间移动;其中在装载位置中,通道的开口处于隔室的外部,并且在释放位置中,通道和通道的开口处于隔室中。
根据本发明的一些实施例,接口进一步包括:枢轴,其可移动地将舱附接到释放装置。
根据本发明的一些实施例,通道的开口处于舱的近端部分上并且枢轴处于舱的远端部分上,使得当舱从装载位置移动到释放位置时,开口围绕枢轴朝向隔室枢转。
根据本发明的一些实施例,舱独立于联接器移动,使得当舱处于释放位置中时,联接器与通道对准,而当舱处于装载位置中时,联接器不与通道对准。
根据本发明的一些实施例,联接器附接到舱,使得当舱处于释放位置中和处于装载位置中时,联接器与通道对准。
根据本发明的一些实施例,联接器附接到舱,使得当舱处于装载位置中的同时储存器被插入到舱中时,联接器形成流动路径,。
根据本发明的一些实施例,扩展组件包括伸缩螺杆(telescoping screw)。
根据本发明的一些实施例,接口进一步包括:装置中的开口,其用于将储存器横向地插入到隔室中。
根据本发明的一些实施例,接口进一步包括:空心针,其与流动路径流体连通并且从皮肤接触表面向外延伸。
根据本发明的一些实施例的方面,提供一种将含有药物的圆柱形储存器装载到具有皮肤接触表面的贴片注射器中的方法,方法包括:提供扩展组件,该扩展组件独立于圆柱形储存器而被安装到贴片注射器,其中扩展的轴线平行于皮肤接触表面,并且还提供联接器,该联接器独立于圆柱形储存器而被安装到贴片注射器;将圆柱形储存器设置在联接器与扩展组件之间的贴片注射器的隔室中,该圆柱形储存器与扩展的轴线同轴并且圆柱形储存器的近端开口面向扩展组件并且圆柱形储存器的远端开口面向联接器;通过储存器的远端开口打开储存器和贴片注射器的注射装置之间的流体路径;以及通过储存器的近端开口使扩展组件扩展以沿着储存器的纵向轴线推动柱塞密封件,从而驱动药物从储存器通过储存器的远端开口到流体路径。
根据本发明的一些实施例,方法进一步包括:利用联接器破坏圆柱形储存器的远端开口的密封件。
根据本发明的一些实施例,设置包括:通过隔室中的开口至少将储存器的远端部分朝向联接器轴向地插入到贴片注射器的隔室中并且在插入之后将密封件推向联接器;并且方法进一步包括:将扩展组件在靠近近端开口且阻止将储存器插入到近端开口中的第一位置与其中推动组件远离近端开口的第二位置之间移动。
根据本发明的一些实施例,方法进一步包括:至少将筒的远端部分轴向地插入到筒舱的通道中,在筒舱处于装载位置中的同时进行插入和流体路径的打开,并且圆柱形储存器的近端开口保持在隔室外部;在打开之后将筒舱和筒一起移动到释放位置,其中筒在扩展组件和联接器之间的隔室内部。
根据本发明的一些实施例,方法进一步包括:至少将筒的远端部分轴向地插入到处于装载位置中的筒舱的通道中,其中圆柱形储存器的近端开口保持在隔室外部;将筒舱和筒一起移动以将筒定位在扩展组件和联接器之间的隔室内部;并且其中在移动之后,扩展组件的扩展将筒的远端密封件推向联接器以导致开口。
根据本发明的一些实施例,方法进一步包括:抵靠使用者的皮肤放置皮肤接触表面;相对于扩展的轴线以30至150度之间的角度将与流体路径流体连通的空心针插入到使用者中。
根据本发明的一些实施例的方面,提供一种用于药物释放装置和药物筒的接口组件,该药物筒具有在其远端部分上的密封件和插入在其近端开口中塞子,组件包括:筒保持隔室;塞子推动组件,其固定地安装到靠近隔室的释放装置;筒舱,其可移动地安装到释放装置;该舱包括:通道,其至少配合筒的远端部分以保持筒,该通道包括:近端开口,其被设定尺寸以用于将筒的远端部分纵向地插入到通道中;以及远端套管,其轴向地突出到通道的远端中以用于在远端部分被插入到通道中时刺穿密封件,并且其中舱在其中筒被插入到通道中的装载位置与其中筒被保持在隔室的内部的释放位置之间移动。
其中舱在其中筒被插入到所述通道中的装载位置与其中筒被保持在所述隔室的内部的释放位置之间移动。
根据本发明的一些实施例的方面,提供一种用于药物释放装置和药物筒的接口组件,该药物筒具有在其远端上的密封件和被插入在其近端开口中塞子,组件包括:筒保持腔(chamber);塞子推动组件,其固定地安装到靠近腔的释放装置;筒舱,其可移动地安装到释放装置;该舱包括:通道,其至少配合筒的远端部分以保持筒,该通道包括:近端开口,其被设定尺寸以用于将筒的远端部分纵向地插入到通道中;以及远端套管,其轴向地突出到通道的远端中以用于在近端部分被插入到通道中时刺穿密封件,并且其中舱在其中筒被插入到通道中的装载位置与其中筒被保持在腔的内部的释放位置之间移动。
根据本发明的一些实施例的方面,提供一种用于药物释放装置和药物筒的接口组件,该药物筒具有在其远端上的密封件和插入其近端开口中的塞子,该组件包括:筒保持腔;腔,其装配包括近端开口的筒以用于插入筒;联接器,该联接器被配置成将筒连接到释放装置的流体路径;塞子推动组件,其可移动地安装到释放装置以用于在靠近近端开口并且阻止将储存器插入到近端开口中的第一位置与其中近端开口是无阻碍的(clear)以用于插入筒的第二位置之间移动。
根据本发明的一些实施例的方面,提供一种用于接口连接药物筒和药物释放装置的方法,该方法包括:提供药物筒,其具有在其远端上的密封件和被插入其近端开口中的塞子,并且还提供塞子推动组件,其被配置成用于安装到释放装置;通过腔的近端开口至少将筒的远端部分插入到药物装置的腔中;通过将位于筒的远端上的密封件推向被安装到腔的远端的联接器在药物释放装置和筒之间打开流体路径;将筒推动组件设置在近端开口后方。
根据本发明的一些实施例的方面,提供一种用于接口连接药物筒和药物释放装置的方法,该方法包括:提供药物筒,其具有在其远端上的密封件和被插入其近端开口中的塞子,并且还提供塞子推动组件,其被配置成用于安装到释放装置;至少将筒的远端部分纵向地插入到可移动筒舱的通道中;通过将位于筒的远端上的密封件推向安装到通道的远端的联接器在药物释放装置和筒之间打开流体路径;移动筒舱以将筒设置在筒推动组件的远端。
根据本发明的一些实施例的方面,提供一种用于在药物筒和药物释放装置之间接口连接的方法,该方法包括:将药物筒的远端开口联接到装置的流动路径;将药物筒插入到远离安装到装置的塞子推动组件的装置中;在筒中通过利用塞子推动装置向远端推动塞子来排出药物。
根据本发明的一些实施例的方面,提供一种用于接口连接药物筒和药物释放装置的组件,该组件包括:腔,其处于装置中以用于容纳筒;联接器,其用于将筒的远端开口连接到装置中的流体路径;开口,其处于装置的侧部以用于将筒插入到腔中;塞子推动组件,其被安装到靠近腔的装置。
根据本发明的一些实施例的方面,提供一种用于接口连接药物筒和药物释放装置的组件,该组件包括:腔,其处于装置中以用于容纳筒;联接器,其用于将筒的远端开口连接到装置中的流体路径;近端开口,其处于腔的近端以用于将筒插入到腔中;塞子推动组件,其被可移动地安装到装置以用于在远离靠近腔的近端开口的位置与靠近并且阻挡腔的近端开口的位置之间移动。
塞子推动组件被可移动地安装到装置,以用于在远离靠近腔的所述近端开口的位置与靠近且阻挡腔的近端开口的位置之间移动。
附图说明
本文仅通过示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,应当强调的是,所示细节是作为示例并且为了说明性地讨论本发明的实施例的目的。在这方面,对于本领域技术人员而言,使用附图进行的描述使得如何实施本发明的实施例显而易见。
在附图中:
图1A是根据本发明的实施例的具有处于装载位置的移动筒舱的筒插入组件的框图;
图1B是根据本发明的实施例的具有处于释放位置的移动筒舱的筒插入组件的框图;
图1C是根据本发明的实施例的筒插入组件的框图;
图1D是根据本发明的实施例的药物释放装置和筒插入组件的框图;
图2A至图2B示出根据本发明的实施例的示例性药物释放装置;
图3A是示出根据本发明的实施例的筒插入方法的流程图;
图3B是示出根据本发明的实施例的筒插入方法的流程图;
图4A是根据本发明的实施例的插入筒的立体图;
图4B是根据本发明的实施例的关闭倾斜舱的立体图;
图4C是根据本发明的实施例的关闭的倾斜舱的立体图;
图4D是根据本发明的实施例的药物释放装置和筒的截面图;
图5A是根据本发明的实施例的将筒插入到铰接舱中的立体图;
图5B是根据本发明的实施例的关闭铰接舱的立体图;
图5C是根据本发明的实施例的关闭的铰接舱的立体图;
图6A是根据本发明的实施例的将筒插入到药物释放装置中的立体图;
图6B是根据本发明的实施例的关闭铰接盖的立体图;
图6C是根据本发明的实施例的关闭的铰接盖的立体图;
图7A是根据本发明的实施例的将筒插入到药物释放装置中的立体图;
图7B是根据本发明的实施例的关闭滑动盖的立体图;
图7C是根据本发明的实施例的关闭的滑动盖的立体图;
图8A是根据本发明的实施例的处于缩回配置的稳定的塞子驱动器(stopperdriver)的特写截面图;
图8B是根据本发明的实施例的扩展配置中的储存器和稳定的塞子驱动器的截面图;
图9是示出根据本发明的实施例的驱动塞子的方法的流程图。
具体实施方式
本发明在其一些实施例中涉及一种用于药物释放装置的筒插入组件,并且更特别地但不排他地,涉及一种用于包括内部伸缩组件的药物装置的插入组件。
概述
本发明的一些实施例的方面涉及用于在药物储存器和药物释放装置之间接口连接的组件和方法。在一些实施例中,接口包括保持筒的隔室和/或被安装到隔室的一侧上的装置的扩展组件和/或到相对侧上到流体路径的联接器。可选地,推动组件的扩展的轴线进入隔室并且总体平行于装置的皮肤接触表面。可选地,储存器与推动组件的扩展的轴同轴地被保持在隔室中。例如,储存器的远端开口面向联接器和/或位于联接器的近端和/或连接到联接器。可选地,联接器将远端开口联接到释放装置的流体路径。可选地,当筒处于适当位置时,推动组件扩展到储存器的近端开口中和/或在储存器中向远端推动塞子,例如柱塞密封件。
推动柱塞密封件可选地从储存器排出药物。例如,药物从远端开口被排出到流体路径。
在一些实施例中,筒可以将药物容纳在圆柱形储存器中。可选地,储存器包括远端开口和/或近端开口。
例如,药物可以被储存在远端密封件和近端密封件之间。
可选地,近端密封件可以包括在药物的位置与近端开口之间插入到储存器中的柱塞密封件。例如,柱塞密封件可以沿着储存器自由地滑动。可选地,远端密封件可以包括隔膜。
在一些实施例中,推动组件可以包括扩展组件。例如,扩展组件可包括伸缩螺杆和/或扩展活塞(例如由气体和/或流体压力驱动)。
可选地或另外地,推动组件可以包括平移元件(translating element)和/或线性致动器。
在一些实施例中,联接器可以开封储存器中的开口和/或提供储存器与释放装置中的流体路径之间的连接。例如,储存器中的开口可以由隔膜密封。联接器可选地包括在第一端上削尖的空心针。例如,针和/或储存器可通过纵向移动而结合,以利用针的第一端刺穿隔膜。可选地,针的第二端连接到释放装置的流动路径。
例如,针可以提供用于流体从储存器流向流体路径的连接。可选地或另外地,联接器可以包括通过筒的针刺穿的隔膜。可选地或另外地,可以包括其它类型的连接器,例如滑动锁和/或鲁尔锁。在一些实施例中,联接器可以通过用户动作连接到筒,例如将筒插入到装置中。例如,将筒插入到装置中可以导致针刺穿隔膜。可选地或另外地,联接器可以通过在装置的另一部件的作用期间和/或作为装置的操作顺序的一部分而被连接到筒。例如,例如推动组件的致动器的力可以迫使筒与联接器连接。可选地或另外地,可以移动联接器以连接到筒。
在一些实施例中,释放装置的隔室可以保持筒与联接器和/或推动组件功能连接。例如,腔可以在期望的方向上对准轴线和/或可以将筒设置在期望的位置中。例如,腔可以便于将筒插入到特定方位中和/或特定位置中。例如,隔室可以包括引导筒和/或配合筒的元件(例如锥形销和/或锥形开口)。可选地或另外地,隔室可以包括迫使筒进入期望的位置中和/或方位中的元件(例如,弹性元件可以将筒推到期望的位置)。可选地或另外地,隔室可以包括将筒保持在适当位置的保持元件(例如夹子和/或闩锁)。
在一些实施例中,筒和/或储存器可通过纵向地滑到隔室中而被设置在隔室中。可选地或另外地,筒和/或储存器的第一侧可以被放置在隔室中,并且然后筒和/或储存器可以被旋转以将第二端设置在隔室中。可选地或另外地,筒和/或储存器可以通过横向地插到隔室中而被设置在隔室中。可选地,筒和/或储存器可以被放置在舱中并且与舱一起被设置到隔室中。
例如,舱可以倾斜到隔室中和/或旋转到隔室中和/或横向地或纵向地滑动到隔室中。
在一些实施例中,药物释放装置可以包括药物施用接口。可选地,药物施用接口可以包括皮肤接触表面。可选地或另外地,药物施用接口可以包括注射装置。例如,注射装置可以将药物注射到使用者的皮肤的一层或多层下方。例如,注射装置可以包括针和/或例如喷射式注射器的无针注射器。
在一些实施例中,流体储存器的纵向轴线(例如,腔体的圆柱形部分的纵向轴线)将基本平行于皮肤接触表面。例如,储存器的纵向轴线与皮肤接触表面之间的角度可以在0至5度之间和/或在5至15度之间和/或15至30度之间和/或30至60度之间变化。可选地,注射装置可以具有轴线(例如,针的纵向轴线和/或流体喷射的方向)。可选地,注射装置的轴线可以基本上垂直于储存器的纵向轴线。可选地或另外地,注射装置的轴线与储存器的纵向轴线之间的角度可以在90至85度之间和/或在85至70度之间和/或在70至30度之间变化。在一些实施例中,皮肤接触表面可以不平坦。例如,储存器的轴线可以在针孔和/或注射位置附近的表面上的点处和/或在离储存器中心最近和/或在储存器的轴线附近的点处平行于皮肤接触表面。
在一些实施例中,筒可以配合通道和/或筒和/或筒舱可以准确地装配到释放装置的隔室中(例如,可能存在小于0.1mm和/或在0.1至0.5mm之间和/或在0.5至1mm之间和/或在1至3mm之间的公差)。可选地或另外地,隔室可以比筒和联接器更长。例如,推动组件与筒之间的空间可以比筒的长度长3至5mm和/或长5至10mm。例如,筒可以被插入到隔室中,而不将连接器连接到筒。在将筒设置在隔室中之后,推动组件可将筒推到联接器中和/或将储存器连接到联接器。
可选地,通道可以被设定尺寸并成形为使得储存器的远端开口面向联接器。
例如,当筒的远端被完全插入到通道中时,储存器的远端开口可以接触联接器和/或联接器可以通过储存器的远端开口形成流动路径。例如,通道可以以下方式被设定尺寸并成形以防止筒扭转和/或围绕旋转:储存器的远端开口将不接触和/或连接和/或直接靠近联接器。例如,通道可以高精度地配合筒的侧部。可选地,通道可以被设定尺寸并成形,使得储存器的近端开口面向扩展组件。例如,通道可以将储存器的远端开口与扩展组件的扩展轴线对准,使得组件的远端扩展将组件的远端移动到储存器中。
可选地,药物释放装置包括在药物释放期间保持筒的隔室和/或安装在隔室后方(靠近隔室)的塞子推动组件。在一些实施例中,筒可以在推动组件的前方(远离推动组件)被横向地插入到隔室中。
在一些实施例中,释放装置可以包括移动筒舱。在舱处于装载位置中时,筒可选地被插入到舱中。随后,舱和筒可选地移动到释放位置中,例如在筒隔室中。例如,在储存器的轴线与推动组件不同轴时,筒可以被装载到舱中。
随后,舱和筒可以被移动到隔室中和/或与推动组件对准。例如,舱可以横向地移动到和/或旋转到隔室中。可选地,在装载位置中,舱的近端开口被设置在药物释放装置的筒隔室外部。
在一些实施例中,筒隔室可以具有筒被插入到其中的近端开口。可选地,在插入筒之后,推动组件可以被移动到近端开口后方的位置中。
在一些实施例中,筒可以被密封。可选地,密封件可以被纵向移动破坏。例如,筒可以包括在筒的前(远)端上的密封件(例如,隔膜)。可选地,通过轴向地插入套管通过筒的前部而刺穿密封件。
例如,套管可以被安装到筒舱和/或筒的远端开口可以通过将筒的远端部分纵向地插入到舱中而被开封。舱和筒可以被横向地移动到筒舱中。
可选地或另外地,密封件可以由位于释放装置的壳体中的套管刺穿。例如,当筒被插入到隔室中时,密封件可以被刺穿。例如,筒可以被纵向地插入到筒隔室的近端开口中。
可选地或另外地,在插入之后,密封件可以被破坏。
例如,柱塞驱动组件可以将筒向远端推入套管中,刺穿筒密封件。
在一些实施例中,在舱处于装载位置时,筒被完全装载到舱和/或连接到联接器。例如,在舱处于装载位置的同时筒被完全装载时,储存器的近端开口在筒隔室外部和/或储存器的部分在隔室外部,例如储存器的5至15%之间和/或15至40%之间和/或40至80%之间和/或80至100%之间。例如,隔室外部的储存器的部分可以被定义为容纳在处于隔室外部的储存器中的药物的部分。
在一些实施例中,推动组件可以包括伸缩组件(TSA)和/或线性稳定器和/或旋转稳定器。例如,旋转稳定器可以被安装到药物释放装置的壳体和/或马达支架,使得推动塞子的伸缩组件的最终元件(final element)上的扭矩相对于马达和/或释放装置的壳体被平衡。
可选地,扭矩将不被施加到药物储存器和/或塞子和/或与药物接触的任何部件。
在一些实施例中,筒推动组件可设置在药物筒的近端开口的后方,而不考虑筒中的塞子的精确纵向位置。可选地,在设置塞子推动组件和/或筒之后,可以扩展TSA直到推动组件接触塞子。例如,可以在将筒插入到药物释放装置中之后和/或在将TSA设置在筒后方之后扩展TSA。
在一些实施例中,TSA的冲程长度可以大于TSA的最小长度。
例如,TSA可具有三个或更多个伸缩轴和/或一个或多个伸缩引导件(guide)。例如,伸缩轴可以包括延伸杆。可选地或另外地,TSA可以具有四个伸缩轴和/或一个、两个或更多个伸缩引导件。可选地或另外地,TSA可以具有五个伸缩轴和/或两个、三个或更多个伸缩引导件。例如,TSA可以具有长度在0.8至1.6cm之间和/或在1.6至3.2cm之间变化的缩回配置。例如,TSA可以具有长度在2.0至6.0cm之间和/或在6至12cm之间变化的延伸配置。
可选地,TSA的延伸长度可以在缩回长度的2.0到3.0倍和/或缩回长度的3.0到5.0倍之间变化。
在详细说明本发明的至少一个实施例之前,应当理解的是,本发明在应用上并不一定限于以下描述中阐述的和/或附图和/或示例中示出的部件和/或方法的构造和布置的细节。本发明能够具有其它实施例或者以各种方式实施或执行。
筒插入组件
现在参照附图,图1A是根据本发明的实施例的插入到处于装载位置的筒舱中的筒的框图。在一些实施例中,筒舱123通过多位置支架125(例如,包括枢轴和/或滑块和/或铰链)可移动地连接到释放装置(例如,释放装置的壳体122a)。可选地,舱包括将药物筒153的储存器120连接到释放装置的流体路径149的联接器148。可选地,当舱123处于装载位置中时,筒153的全部或部分被装载到舱123。例如,当筒153被装载到舱中时,筒153可以被连接到联接器148。可选地,当筒123处于装载位置中时,舱123的全部或部分位于释放装置的壳体的外部。例如,在装载位置中,舱123和/或筒153的100%至75%之间和/或75%至50%之间和/或50%至25%之间和/或25%至5%之间可以处于释放装置的外部和/或释放装置的壳体122a和/或筒隔室的外部。可选地或另外地,舱123可以包括用于将筒153装载到舱123的近端开口。在装载位置中,近端可选地远离释放装置。
在一些实施例中,筒153包括药物储存器120。例如,储存器120可以包括近端开口141和/或远端开口。
可选地,开口可以由例如隔膜的密封件146封闭。当被装载到舱153中处于装载位置中时,开口141可以远离(free of)释放装置和/或在释放装置的外部。储存器120可以容纳药物。例如,药物可以被密封在塞子140和密封件146之间。
在一些实施例中,联接器148可以包括套管。当筒153被装载到舱123中时,套管被可选地插入穿过密封件146的隔膜,从而提供药物144与流体路径149之间的流体连通。可选地,联接器148被安装到舱123和/或与舱123一起移动。可选地,联接器148被安装到壳体122a。可选地,对于舱123的不同位置,流体路径149保持联接器148与释放装置之间的流体连通。
例如,流体路径149可以包括柔性管。在一些实施例中,套管和/或流体路径可以与注射针流体连通。
在一些实施例中,释放装置可以包括贴片注射器。
可选地,在分配位置中,筒的长轴线和/或筒隔室的长轴线基本平行于贴片注射器的基部和/或与贴片注射器的基部成小于10度的角度和/或在10度与30度之间的角度。
可选地,注射器的基部接触患者的皮肤。可选地,注射器的基部可以包括用于粘附到患者的粘合剂。在一些实施例中,注射针可以被插入到患者体内。例如,注射针可以在基本上垂直于基部的方向上和/或以与基部成85至90度之间和/或与基部成75至85度之间和/或与基部成60至75度之间的角度被插入到患者体内。
在一些实施例中,释放装置可以包括塞子驱动组件150。驱动组件150可选地被靠近筒隔室固定地安装在壳体122a上。在装载位置中,筒153和/或舱123可以不与驱动组件150对准和/或联接。
现在参照图1B,图1B是根据本发明的实施例的插入到处于释放位置的筒舱中的筒的框图。在释放位置中,驱动组件150可选地设置为靠近筒153和/或开口141。在释放位置中,驱动组件150可选地与开口141对准和/或接合到塞子140。例如,在将舱123和/或筒153设置在释放位置中之后,驱动组件150可推进塞子接口以接触和/或推动塞子140和/或通过联接器148将药物144排出到流体路径149。
例如,在释放位置中,舱123和/或筒153的100%至75%之间和/或75%至50%之间和/或50%至25%之间和/或25%至5%之间可以处于释放装置和/或壳体122a和/或筒隔室的内部。
现在参照图1C,图1C是根据本发明的实施例的插入到释放装置中的筒的框图。在一些实施例中,联接器148可以被安装到释放装置的壳体122b。可选地,壳体122b可以包括到筒隔室的近端开口。例如,筒153可以被纵向地插入到近端开口中,直到联接器148接合储存器120的远端开口和/或刺穿密封件146。可选地或另外地,壳体122b可以具有侧部开口。例如,筒153可以被横向地插入到侧部开口中。
可选地,驱动组件150可以最初向远端推动筒153,直到联接器148接合储存器120的远端开口和/或刺穿密封件146。
现在参照图1D,图1D是根据本发明的实施例的示出柱塞推动组件的细节的被插入到处于释放位置的筒舱中的筒的框图。
驱动组件150可选地由壳体122b支撑。例如,壳体122b可以平衡驱动组件150和塞子140和/或筒153之间的线性力。驱动器组件150可选地包括例如引导件104的防旋转引导件。防旋转引导件104可选地支撑驱动组件和/或平衡驱动组件与例如马达108的马达之间的扭矩。
在一些实施例中,塞子驱动组件150可以包括伸缩组件(例如TSA152)。
可选地,TSA 152包括例如螺纹驱动轴110的近端轴和/或螺纹中间轴112,和/或例如螺纹推动轴114的远端轴。轴110、112和/或114可以被联接,使得相对于推动轴114旋转驱动轴110导致TSA 152伸长和/或缩短。可选地,驱动轴110的轴向移动被线性稳定器106限制,使得相对于推动轴114旋转驱动轴110导致推动轴114相对于线性稳定器106线性地移动。可选地,联接器将引导件104和/或推动轴114链接到壳体122b。例如,推动轴114的旋转可以被壳体122b限制,使得相对于壳体122b旋转驱动轴110导致TSA 152伸长和/或缩短。
可选地或另外地,驱动轴110和/或推动轴114可以由螺母和/或螺纹盘和/或环代替。
在一些实施例中,马达108可以包括DC电马达、化学发动机、无刷马达、AC马达、致动器等。
在一些实施例中,线性稳定器106和/或壳体122b可以附接到药物筒153并且/或者推动轴114可以邻接塞子140,使得扩展的TSA 152使塞子140相对于储存器120轴向移动。
塞子140相对于储存器120的轴向后向力(例如,由于塞子与储存器的壁之间的摩擦和/或由于流动阻力)相对于线性稳定器106和/或壳体122b可选地平衡。
在一些实施例中,马达108可以将扭矩施加到驱动轴110。
可选地,防旋转引导件104可以附接到药物筒153,使得启动马达108使推动轴114相对于驱动轴110轴向运动。驱动轴110、中间轴112和/或推动轴114之间的摩擦可选地通过马达108引导件104和/或壳体122b之间的反扭矩来平衡,使得TSA 152用作线性致动器,其在与药物接触的装置的部件(例如,塞子140和/或筒153)上施加净(net)线性力(和/或可忽略的扭矩)。
在一些实施例中,中间轴112和/或防旋转引导件104可以轴向移动。例如,中间轴112和/或防旋转引导件104可以移动到储存器120中和/或从储存器120移出。例如,引导件104可以例如通过轨道可滑动地和/或防旋转地连接到壳体122b。
在一些实施例中,TSA 152的部件的移动顺序可以不固定。
例如,在一些实施例中,中间轴112与驱动轴110一起自由旋转和/或与推动轴114一起旋转。例如,某些部件(例如,中间轴112)的位置在一些配置中(例如,当TSA152部分地延伸时)可能是不确定的。例如,部件可以移动,而不改变TSA 152的长度。
在一些实施例中,引导件104可以滑动和/或防旋转地连接到壳体122b。例如,连接可以包括纵向轨道。推动轴114可以例如通过纵向轨道滑动和/或防旋转地连接到引导件104。
在一些实施例中,驱动轴110可以是内轴,并且推动轴114可以是外轴。可选地或另外地,驱动轴110可以是外轴,并且推动轴114可以是内轴。本发明的任何或所有部件可以由塑料和/或金属和/或其它材料制成。
药物释放装置
图2A至图2B示出根据本发明的一些实施例的药物释放装置。可选地,药物释放装置包括在筒隔室的相对端上的柱塞推动组件和/或流体路径联接器。可选地,筒隔室使药物筒与平行于装置的皮肤接触表面的筒储存器的轴线配合。
图2A是根据本发明的示例性实施例的药物释放装置222和筒220的立体图。在一些实施例中,药物释放装置222可以包括筒隔室224。
可选地,隔室224被设定尺寸以配合筒220。例如,筒220在活塞推动组件252和联接器(例如,包括可以包括例如图2B所示的空心针248的联接器)之间紧密地装配在隔室224中。
在一些实施例中,筒220装配在筒舱223内侧的隔室224中。可选地,舱223从隔室224打开。例如,在打开位置中(例如,如图2A所示),筒220可以被插入到舱223中。例如,为了将筒220设置在隔室224中,使用者可以将筒220插入到处于打开位置的舱223中并且然后关闭舱223;从而将筒220插入到隔室中。
可选地,舱223通过枢转到隔室224中和/或从隔室224枢转出而打开和/或关闭。
在一些实施例中,药物释放装置222可以包括施用接口。例如,装置222包括皮肤接触表面230。
例如,当释放药物时,抵靠使用者的皮肤放置表面230。可选地,皮肤接触表面230的全部或部分涂覆有粘合剂。
例如,在药物释放期间,粘合剂可以将装置保持到使用者。
可选地,表面230包括针罩232和/或药物释放孔234。
例如,针可以从孔234延伸到使用者的皮肤中并且/或者药物可以通过针和/或通过孔234被排出到使用者中。可选地,在使用之后,罩232可以延伸以覆盖针并且/或者防止刺戳危险。可选地或另外地,在药物排出之后,针可以缩回到装置222中,例如以防止刺戳危险。可选地或另外地,药物释放装置可以包括喷射注射器和/或其它注射装置。
图2B是根据本发明的实施例的注射器222的剖视图。在图2B中,示出筒220被设置在隔室224内部。可选地,筒220包括圆柱形储存器219。例如,当设置在隔室224内部时,圆柱形储存器219的纵向轴线平行于皮肤接触表面230。在示例性注射装置220中,示出注射针236处于扩展位置。可选地,在扩展位置中的针236垂直于储存器219的纵向轴线。可选地,例如包括柔性管249的流体路径将针236连接到联接器。例如,联接器可以包括空心针248。可选地,联接器的针248在隔室224的一端处被安装到装置222。可选地,扩展组件252在隔室224的相对端处被安装到装置222。当筒220被装载到装置222中时,其可选地被放置在扩展组件252和联接器之间。可选地,当筒220被设置在隔室224内部时,扩展组件252沿与筒220同轴的扩展轴线扩展。
在一些实施例中,联接器包括空心针248。例如,针248打开流体路径249和储存器219之间的流体连通。
例如,当筒220被插入到舱223中时,隔膜246被针248刺穿。
在一些实施例中,在筒220被设置在隔室224内部之后,针248可以刺穿隔膜246。例如,扩展组件252可以将筒220纵向地推入针248中。例如,隔室224可以略长于筒223。可选地,针可以例如在1至3mm之间和/或在3至6mm之间和/或在6至12mm之间穿透隔膜。可选地,筒可以在比针穿透多1至3mm之间和/或多3至6mm之间移动。例如,隔室可以比筒长3至6mm和/或长6至12mm。
在一些实施例中,筒220可以包括注射筒。例如,注射筒可以包括圆柱形储存器219。储存器219可选地包括具有远端开口256和/或近端开口241的圆柱形腔体。
可选地,储存器219的远端部分填充有药物。
在一些实施例中,柱塞密封件240被插入到储存器219中。例如,塞子240可以将药物的位置与近端开口241之间的储存器219密封。可选地,注射筒可以包括近端凸缘221。例如,凸缘221可以便于将注射筒设置和/或保持在舱223和/或隔室224中。可选地或另外地,注射筒220可以在自动填充机中被填充。例如,填充机可以使用凸缘221来处理和/或设置注射筒。例如,筒220的注射筒可以是适合标准填充机的标准尺寸和/或形状。在一些实施例中,开口256可以与储存器219同轴。
可选地或另外地,开口256可以相对于储存器219偏心地设置。
可选地,扩展组件252包括伸缩螺杆组件。
例如,伸缩组件252包括驱动器210,驱动器210可选地通过变速器和/或马达旋转。例如,变速器可以包括齿轮226。可选地,变速器和/或驱动器和/或马达保持永久接合。例如,变速器和/或马达和/或驱动器可以在将筒插入装置的隔室之前、在将筒插入装置的隔室期间和/或在将筒插入装置的隔室之后保持接合。
驱动器210可选地由线性稳定器从远端支撑,例如,推向装置222的壳体的轴承206。可选地,驱动器210由两个中间螺杆212a和212b螺纹连接和/或螺纹连接到柱塞驱动器214。
例如,柱塞驱动器214可以被允许相对于驱动器210纵向地移动和/或例如通过防旋转引导件204而被阻止相对于装置222的壳体旋转。例如,旋转驱动器210导致例如轴210、212a、212b和214的螺纹部件的相对旋转和/或组件252的纵向延伸。例如,柱塞驱动器214可以沿着储存器219的轴线驱动和/或被驱动到储存器219中。当柱塞驱动器214移动到储存器219中时,其可选地向远端推动柱塞密封件240和/或驱动药物离开开口246和/或通过针248和/或进入流体路径249和/或通过针236和/或进入使用者。在一些实施例中,扩展组件202驱动柱塞驱动器214进入开口241。例如,柱塞驱动器214可以移动到开口241中,直到其接合和/或接触柱塞密封件240。可选地,在柱塞驱动器214接合密封件240之后,扩展组件252的进一步扩展将密封件240向远端驱动到储存器219中。
可选地,将密封件240向远端驱动到储存器219中导致例如通过储存器219的远端开口256排出药物。
填充筒
根据本发明的一些实施例,可以利用标准药物设备填充储存器(例如,在现有的具有为标准注射器和/或筒制成的填充设备的洁净室中)。
可选地,塞子驱动器接合位于储存器内任意位置处的塞子。在一些实施例中,塞子驱动器可以组装有卡扣在一起的部件。部件可选地由诸如例如聚甲醛(POM)树脂的塑料的模制材料制成。
在一些实施例中,提供药物储存器。可选地,储存器可以被预填充。例如,储存器可以使用标准填充设备来填充。例如,储存器可以具有圆柱形和/或管状孔或腔体和/或任意截面的孔。例如,主体可以是直圆柱体的形式。可选地,内部腔体可以是任意的形状。例如,内部腔体可以在其至少一半长度上和/或在其至少90%的长度上具有光滑的壁。例如,储存器的空腔在其至少一半长度上和/或在其长度的至少90%上可以基本上是直圆柱体。例如,内部腔体可以在其至少一半长度上和/或在其至少90%的长度上具有光滑的壁。
例如,腔体的截面在其至少一半的长度上和/或在其至少90%的长度上可以是均匀的。可选地,储存器可以包括远端开口。
在一些实施例中,储存器的远端部分可以包括套管,例如皮下注射针和/或用于此的支架。可选地或另外地,储存器的远端部分和/或远端开口可以包括例如隔膜的密封件和/或例如针盖的无菌盖。储存器的近端可以包括近端开口。可选地,近端开口可以大于远端开口。例如,近端开口的截面积可以在远端开口的截面积的5至50倍之间和/或远端开口的截面积的50至500倍之间变化。可选地,开口可以倾斜和/或可以平滑地连接到储存器的内部腔体。可选地,塞子可以被插入到近端开口中。可选地,例如塞子的柱塞密封件可以密封和/或保持储存器的内容物的无菌性。可选地,塞子的位置可以根据储存器的内容物的体积而变化。可选地,筒的近端可以包括凸缘。例如,凸缘可以从筒的外围的20%至100%之间延伸。例如,凸缘可以从近端开口的内壁延伸1mm至2cm之间。可选地,储存器可以例如由模制玻璃或塑料和/或切割和/或处理的管被制造成单个一体化单元(integral unit)。
药物筒的插入
图3A是示出根据本发明的实施例的筒插入方法的流程图。例如,筒可以被插入移动舱。例如,舱可以被打开385到装载位置。在舱处于装载位置的情况下,筒和/或其部分可选地被装载323a到舱。例如,舱可以包括筒的近端开口和/或筒的远端部分可以例如通过其近端开口被纵向地插入到舱中。例如,筒的1至5%之间可以被插入到舱中和/或筒的5至15%之间可以被插入到舱中和/或筒的15至40%之间可以被插入到舱中和/或筒的40至75%之间可以被插入到舱中和/或筒的75至100%之间可以被插入到舱中。在一些实施例中,将筒插入到舱中可以将联接器连接326a到筒。例如,筒可以包括套管,该套管向近端突出到舱中的筒通道的远端中。
当筒被插入到通道中时,套管可选地刺穿筒的远端上的隔膜。
在一些实施例中,在筒被装载323a到舱中的情况下,舱可以被关闭325以将舱和/或筒设置在分配位置中。
例如,舱可以滑动或枢转到释放装置的侧部中的开口中。当筒在释放位置中时,塞子推动组件可以可选地靠近筒被定位和/或与药物储存器中的近端开口对准和/或与塞子对准。
在一些实施例中,在筒和/或舱处于关闭325(例如,处于分配位置)的情况下,塞子驱动组件可以被推进313。
扩展塞子驱动器可以导致通过塞子接口接合塞子和/或将塞子向前驱动到药物储存器中和/或排出314药物。
图3B是示出根据本发明的实施例的筒插入方法的流程图。在一些实施例中,筒可以在不移动舱的情况下被横向地插入323b到分配装置中。可选地或另外地,筒可以被纵向地插入323b到装置中。
在一些实施例中,筒可以被横向地插入323b到释放装置中。例如,筒可以被插入323b到通向筒隔室的装置的壳体的侧部中的开口中。可选地,在插入323b之后,塞子驱动器从筒后方朝向塞子推进313。塞子驱动器可选地接合塞子。筒可选地(例如,通过塞子驱动器)向前驱动。例如,当筒的远端被密封时,柱塞上的压力可不驱动药物排出。塞子上的压力和/或流体压力可选地向前驱动筒。向前驱动筒可选地将药物储存器连接326b到联接器和/或(例如,通过刺穿隔膜)在筒和释放装置之间形成流体路径。打开从储存器离开到药物释放装置的流体路径可以便于塞子在药物储存器内部的推进和/或药物的排出。
塞子驱动组件的进一步推进313可选地将塞子推进到药物储存器中和/或排出314药物。例如,药物可以通过联接器被排出314且/或进入释放装置的流体通道和/或进入使用者。可选地或另外地,在插入到舱中之后(例如,在舱正被关闭到释放位置的同时和/或在舱被关闭到释放位置之后),注射器可以通过除了扩展组件以外的机构被向前驱动,例如通过倾斜表面被向前推动,以连接到联接器。
在一些实施例中,筒可以被纵向地插入323b到装置中。例如,装置可以具有通向筒隔室的近端开口。将筒纵向地插入323b到筒隔室中可选地将药物储存器连接326b到联接器和/或(例如,通过刺穿隔膜)在筒和释放装置之间形成流体路径。可选地,在隔膜已经被刺穿之后,塞子驱动器从筒后方朝向塞子推进313。塞子驱动器可选地接合塞子。塞子驱动组件的进一步推进313可选地将塞子推进到药物储存器中和/或排出314药物。例如,药物可以通过联接器被排出314和/或进入释放装置的流体通道和/或进入使用者。
具有倾斜筒舱的插入组件
图4A是根据本发明的实施例的将筒子插入到倾斜舱中的立体图。在一些实施例中,例如如图4A所示,筒舱423从药物释放装置422倾斜到装载位置。可选地,舱423具有通向圆柱形通道(其可以例如通过窗口447看到)的近端开口441b。通道可选地被设定尺寸以配合筒420。例如,示出筒420可选地通过开口441b被插入473到通道中。例如,舱423沿着可移动的多位置支架(例如,枢轴425)倾斜。可选的支撑件445在装载位置中支撑舱423。可选地,例如如图4B所示,舱423和/或筒420围绕枢轴425旋转到筒隔室424中的关闭位置中。可选地,例如如图4B所示,在关闭位置中,筒420和/或舱423与柱塞推动组件和/或隔室424同轴。
在一些实施例中,筒420可以包括标准注射器。例如,筒420可以包括近端开口441a。柱塞密封件440可选地通过开口441a插入,以将筒420的近端部分与包括在其远端部分中的药物隔绝。储存器的远端可选地包括开口456和/或密封件(例如,如图4D所示的隔膜446)和/或针支架。可选地,筒420包括近端凸缘421。
在一些实施例中,释放装置422可以包括贴片注射器。例如,注射器的皮肤接触表面430可以平行于和/或几乎平行于筒420的长轴线。例如,在图4A至图4D中,注射器的皮肤表面基部面向该页面。皮肤接触表面可选地完全或部分被粘合剂层429覆盖。释放装置可选地包括电子器件隔室435。释放装置可选地包括注射针插入组件433。例如,在将皮肤接触表面放置在患者身体上之后,使用者可以将组件433的突出按钮推入注射器中以将针从皮肤接触表面向外释放到患者体内。
图4B是根据本发明的实施例的在装载位置具有插入的筒的倾斜舱的立体图。在图4B中,筒420可选地已经被插入到舱423中并且通过窗口447可见。在图4A至图4D的示例性实施例中,在将筒插入舱423之后,舱423通过倾斜到释放装置422的筒隔室中而被可选地关闭475。
图4C是根据本发明的实施例的关闭的倾斜舱的立体图。一旦舱423被关闭,可选地位于靠近开口441a的装置422的近端中的柱塞驱动组件可以向远端驱动柱塞密封件440和/或排出药物。
图4D是根据本发明的实施例的具有倾斜舱的药物释放装置和在装载位置中的筒的截面图。在图4D中,示出塞子驱动组件的示例性实施例。塞子驱动器可以包括例如包括防旋转引导件404和/或塞子驱动轴410和/或中间轴412和/或塞子推动轴414的TSA。可选地,引导件404通过允许引导件在远端方向上线性滑动但防止引导件404相对于装置422旋转的轨道而被连接到装置422。可选地,驱动轴410由例如轴承406的线性稳定器支撑。例如,轴承406放置在装置422的壳体上。轴承406可选地允许轴410旋转,但是防止轴410相对于装置422向近端移动。
在一些实施例中,包括例如齿轮426的变速器可选地将轴410连接到马达408。马达408可选地相对于装置422旋转轴410。在引导件404可选地防止轴414相对于装置422旋转的同时,旋转的轴410相对于装置422可选地在轴410和414之间产生相对旋转。可选的一组螺纹配合轴410、412和414可选地将相对旋转转换成组件的线性伸缩。可选地,塞子推动组件被固定在装置422的近端部分中和/或靠近筒隔室和/或在靠近筒420的分配位置。电子器件隔室435可以包括例如电源(例如,电池493)和/或控制器(例如,印刷电路板499)。
在一些实施例中,在装载位置中,舱可以从隔室424枢转出1至10度之间和/或10至30度之间和/或30至60度之间的角度和/或60至90度之间的角度。
在一些实施例中,当筒420被插入到隔室423中并且隔室423被关闭和/或筒420处于分配位置时,推动轴414的远端推进向远端推动柱塞密封件440和/或将药物444排出到注射器的流体路径中。注射器的流体路径可以可选地包括从筒420通向管449到插入组件433的注射针和/或流出到患者体内的套管448。可选地,管449是柔性的和/或允许套管448相对于装置422和/或插入组件433移动(例如,当舱423被打开和/或关闭时,套管448可以与舱423一起移动)。可选地,套管448被弯曲成例如在90至85度之间和/或在85至60度之间和/或在60至45度之间的范围内。
具有铰接筒舱的插入组件
图5A是根据本发明的实施例的将筒插入到铰接舱中的立体图。在示例性装置522中,筒舱523摆出到装载位置(例如,如图5A所示)。
在装载位置中,筒420可以通过近端开口541被插入到舱523中。例如,开口541可以通向通道。
可选地,通道是圆柱形的和/或紧密地配合筒。关闭的远端壁545可选地支撑舱523的远端。可选地,舱523旋转到关闭位置(例如,如图5C所示),其中插入其中的舱523和/或筒520与筒隔室524和/或筒推动组件同轴。
图5B是根据本发明的实施例的在装载位置中并且装载有筒的铰接舱的立体图。例如,一旦被装载,舱523通过围绕可移动的多位置支架(例如,如图5C所示的铰链525)转动而被关闭575到分配位置中。
图5C是根据本发明的实施例的在分配位置中的铰接舱的立体图。装置422的近端可选地包括例如如图4D所示的塞子驱动组件。舱523可选地包括套管。
图6A是根据本发明的实施例的将筒插入到药物释放装置中的立体图。例如,装置可以具有铰接盖623。例如,图6A至图6C的实施例不包括筒舱。可选地,在装载位置中,装置622的近端盖623转动打开,从而露出到筒隔室624(例如,通过窗口447看到)的开口641。筒420可以可选地纵向地插入673到筒隔室624中。可选地在筒隔室的远端中突出的套管可选地在插入673时刺穿筒420的远端上的隔膜和/或在插入时将筒420连接到装置622的流体路径。可选地或另外地,在插入后,隔膜可以被刺穿。例如,筒可以通过扩展组件推入联接器中。图6B是根据本发明的实施例的在筒的插入之后在装载位置中的铰接盖装置的立体图。在筒420的插入673之后,装置623的近端盖可选地转动675关闭。
图6C是根据本发明的实施例的关闭的铰接盖623的立体图。可选地,当盖被关闭时,柱塞推动组件位于近端盖623中和/或被设置成靠近筒420。
图7A是根据本发明的实施例的将筒插入到药物释放装置中的立体图。例如,图7A至图7C的装置包括滑动盖723。例如,图7A至图7C的实施例不包括筒舱。可选地,在装载位置中,装置722的近端盖723滑动打开,从而露出到筒隔室(例如,通过窗口447看到)的开口741。筒420可以可选地纵向地插入773到筒隔室724中。套管可选地突出到筒隔室724的远端中。套管可选地在插入773时刺穿筒420的远端上的隔膜和/或在插入时和/或在插入后将筒420连接到装置722的流体路径。
图7B是根据本发明的实施例的在插入筒之后在装载位置中的滑动盖装置的立体图。在筒420的插入773之后,装置722的近端盖723可选地滑动775关闭。
图7C是根据本发明的实施例的关闭的滑动盖723的立体图。可选地,当盖723被关闭时,柱塞推动组件位于近端盖723中和/或被设置成靠近筒420。
具有防旋转引导件的塞子驱动器由装置壳体稳定
图8A是根据本发明的实施例的处于收缩构造的塞子驱动器的特写截面图。在一些实施例中,TSA452由药物释放装置822的壳体稳定。例如,防旋转引导件404的突出部405连接到被附接到装置822的壳体和/或内在于(intrinsic to)装置822的壳体的导轨805。驱动轴410可选地相对于装置822的壳体线性地稳定。例如,线性稳定可以经由轴承806。为了简单起见,在图8A至图8B中未示出变速器和马达组件。可选地,装置822具有皮肤接触表面830。
图8B是根据本发明的实施例的处于扩展构造的筒和塞子驱动器的截面图。
可选地,驱动轴410旋转地扩展TSA 452。例如,TSA 452扩展到筒420中和/或将柱塞密封件440推入筒420中和/或从筒420排出药物。可选地,当TSA 452扩展时,防旋转引导件移动到筒420中。例如,当防旋转引导件404滑入套管筒420中时,突出部405可以滑下轨道805和/或当推动轴414相对于防旋转引导件404滑动时,突出部415a可以滑下轨道415b。脊(ridge)821防止筒420相对于装置822向远端线性地移动。可选地,当筒420被插入装置822的筒隔室中时(例如,在释放位置中),接触表面830平行于筒420的储存器的轴线。可选地,接触表面830平行于扩展组件452的轴线。可选地,当筒420被插入到装置822的筒隔室中时,扩展组件452的扩展轴线与筒420同轴。
驱动塞子
图9是示出根据本发明的实施例的驱动柱塞密封件的方法的流程图。在一些实施例中,通过旋转910单个轴和/或通过阻止单个轴的旋转,TSA可以扩展或缩回其最小长度的100%以上。例如,TSA可通过旋转910驱动轴而被打开。可选地,近端驱动轴可以位于靠近远端推动轴。例如,驱动轴可以通过被安装在装置上的马达相对于药物释放装置旋转910。
例如,驱动轴的旋转910可以相对于药物释放装置的壳体和/或相对于马达的支架。可选地,当驱动轴正在旋转时,可阻止902推动轴旋转。
例如,防旋转引导件可防止推动杆相对于药物释放装置壳体和/或相对于马达和/或相对于马达支架旋转。相对于推动轴旋转910驱动轴可选地扩展TSA和/或推动轴和/或塞子。
在一些实施例中和/或在一些构造中,中间轴可以独立于TSA的长度而轴向地移动。例如,当TSA被扩展时,中间轴可以与推动轴一起线性地扩展912和/或与驱动轴一起旋转913。
可选地,对于TSA的一些长度,中间轴的位置可以是不确定的。例如,旋转910驱动轴可以例如将中间轴延伸912到储存器中(例如,当驱动轴旋转得比中间轴更快时和/或通过将驱动轴螺纹联接到中间轴)。
可选地,将中间轴扩展912到储存器中同时将推动轴扩展914到储存器中。可选地或另外地,旋转910驱动轴可以旋转913中间轴。可选地,旋转913中间轴将推动轴扩展914到储存器中(例如,通过将驱动轴螺纹联接到中间轴)。可以同时和/或顺序地发生中间轴的旋转和/或扩展。
在一些实施例中,防旋转引导件可以轴向浮动。例如,当TSA被扩展时,防旋转引导件可以与推动轴一起扩展904(例如,相对于储存器轴向移动和/或轴向移动到储存器中)和/或防旋转引导件可以相对于储存器保持静止和/或推动轴可以相对于防旋转引导件轴向地扩展914。可选地,对于TSA的一些长度,防旋转引导件的位置可以是不确定的。
药物释放装置的示例性尺寸
在一些实施例中,储存器(例如,注射器)的有效载荷可以包括例如0.5至3ml之间和/或3至6ml之间和/或6至10ml之间和/或10至15ml之间的药物和/或更多。可选地,储存器的长度(例如,容纳药物的腔体的圆柱形部分的长度)可以在2至5cm之间和/或在5至10cm之间变化。
可选地,储存器的宽度(例如,容纳药物的腔体的圆柱形部分的内部宽度和/或直径)可以在例如0.5cm至2cm之间和/或2至5cm之间变化。在一些实施例中,注射器可以以单个剂量排出整个有效载荷。药物释放装置可以包括例如笔式注射器和/或贴片注射器和/或用于驱动塞子和/或排出有效载荷的内部驱动的驱动器。注射器的储存器可以被定向成平行于受试者的皮肤和/或垂直于皮肤和/或处于在平行和垂直之间,例如在60到90度之间和/或在30到60度之间和/或在0到30度之间的角度。
为了该应用的目的,内部驱动的注射器驱动器可以被定义为由至少暂时存储在注射器内的能量驱动的驱动机构。
能量可以存储在能量供应部中,例如作为化学势(例如,产生膨胀气体的化学品和/或电池)和/或(例如,存储在弹性构件和/或弹簧和/或加压气体中的)机械势。例如,驱动器可以被设计成在20秒和120秒之间的时间段和/或在120秒和600秒之间的时间段和/或在600秒和7200秒之间的时间段和/或更长的时间段内排出有效载荷。在一些实施例中,排出可以由驱动器驱动。内部供能的驱动器可以由各种机构来功能,其包括例如马达(其包括例如DC马达、致动器、无刷马达)和/或变速器、其包括例如伸缩组件和/或螺纹元件和/或齿轮和/或联接件和/或弹性机构(例如,弹簧和/或橡胶带)和/或膨胀气体和/或液压致动器)。
根据本发明的一些实施例的药物释放装置可以包括储存器。例如,储存器可以包括药物容器和/或标准型注射器。可选地,标准型注射器可以使用标准设备和/或在无菌隔室中预装载有药物。预装载的标准型注射筒可以可选地包括近端开口。塞子可以可选地密封近端开口和/或保护注射筒内容物的无菌性。
无菌针(例如,空心针)可以可选地连接到注射器筒。例如,针的空心部可以与筒部的内部流体连通。针可以可选地刚性地附接到筒部的远端。针的全部和/或部分的无菌性可以例如由无菌盖保护。当注射筒被提供和/或安装到注射器中时,无菌盖可以保留在针上。例如,药物储存器可以可选地包括刚性地附接到针的圆柱形筒部。可选地,针的长轴线与注射筒的筒部的长轴线可以是平行的和/或同轴的。可选地,针可以被安装在筒部的远端上。可选地,针尖可指向远端方向。在一些实施例中,塞子可以沿着筒部的内部轴向滑动以排出药物有效载荷。例如,药物可以通过空心针被排出。
在一些实施例中,针的暴露长度(例如,在药物排出期间和/或套管的插入期间从皮肤接触表面突出)可以适于执行注射。例如,针的暴露长度可以适于皮内注射和/或具有例如24G至30G之间的规格范围和/或例如为7至10mm之间的长度范围和/或针的暴露长度可以适于皮下注射和/或具有例如23G至28G之间的规格范围和/或例如9至28mm之间的长度范围和/或针的暴露长度可以适于肌内注射和/或具有例如18G至23G之间的规格范围和/或例如24至40mm之间的长度范围和/或针的暴露长度可以适于静脉注射和/或具有例如15G至22G之间的规格范围和/或例如为24至40mm之间的长度范围。
在一些实施例中,TSA可以产生在例如0.02至0.2N之间和/或0.2至0.5N之间和/或在0.5至5N之间和/或在5至60N之间和/或在60至90N之间变化的力。可选地,注射药物所需的力(例如,注射筒柱塞上的力)可以在0.5至90N之间变化。例如,注射药物所需的力可以取决于药物的注射速率和/或粘度和/或注射筒几何形状和/或针尺寸。
在一些实施例中,注射药物的压力可以包括扭矩。
例如,药物的注射可以由塞子驱动。塞子可以可选地由例如螺纹螺杆和/或齿和/或伸缩组件的螺纹组件驱动。可选地,齿和/或相关联的螺杆的间距可以例如在0.5至2mm之间和/或在2至4mm之间和/或在4至8mm之间变化。螺杆的直径可以在例如4至15mm之间变化。功率注入的扭矩可以例如在0.2至1.0N*cm之间和/或在1.0至10N*cm之间变化。
在注射期间,塞子的线性运动可以例如在5至40mm之间和/或在40至50mm之间变化。塞子的移动的长度可以例如随着待注射的药物的体积而变化,该待注射的药物的体积可以例如在0.5至3ml之间和/或3至10ml之间和/或10至30ml之间变化。
预期的是,在从本申请得到的专利的有效期内,许多相关技术将被开发,并且术语的范围旨在先验地包括所有这样的新技术。
如本文所使用的,术语“大约”指±5%。
术语“包括”、“包括有”、“包含”、“包含有”、“具有”以及它们的同根词是指“包含但不限于”。
术语“由......组成”是指“包括但限于”。
术语“基本上由...组成”是指组合物、方法或结构可以包括另外的成分、步骤和/或部件,但是只有当附加成分、步骤和/或部件不会实质上改变要求保护的组合物、方法或结构的基本和新颖特征时。
如本文使用的,单数形式“一”、“一个”和“该”包括复数参考,除非上下文另有明确指示。例如,术语“化合物”或“至少一种化合物”可以包括多种化合物,包括其混合物。
在整个本申请中,本发明的各个实施例可以以范围形式呈现。应当理解的是,范围形式的描述仅仅是为了方便和简洁,并且不应被解释为对本发明的范围的僵化限制。因此,对范围的描述应当被认为具体披露所有可能的子范围以及该范围内的各个数值。例如,对诸如从1至6的范围的描述应当被认为具有诸如从1至3、从1至4、从1至5、从2至4、从2至6、从3至6等的具体公开的子范围以及例如1、2、3、4、5和6的该范围内的个别数字。无论范围的广度如何,这都适用。
无论何时在本文中指出数值范围,都意味着在指定范围内包括任何引用的数字(分数或整数)。短语“在第一指示数字和第二指示数字之间的变化(ranging)/变化(ranges)”和“从第一指示数字至第二指示数字之间变化/变化”在本文中可互换使用并且意味着包括第一指示数字和第二指示数字及其间的所有小数和整数。
应当理解的是,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地提供。相反,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提供或以任何合适的子组合提供或适于本发明的任何其它描述的实施例。在各个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,除非该实施例在没有那些元件的情况下不起作用。
本说明书中提及的所有出版物、专利和专利申请通过引用整体并入本说明书中,就像每个单独的出版物、专利或专利申请被具体地和单独地指示通过引用并入本文一样。另外,本申请中任何参考文献的引用或识别不应被解释为承认该参考文献可用作本发明的现有技术。在使用章节标题的范围内,它们不应被解释为必然的限制。

Claims (11)

1.一种药物释放装置,包括:
隔室,其被设定尺寸以接收筒,其中所述隔室包括被配置成从所述隔室打开的筒舱,其中,在打开位置,所述筒可以被插入到所述筒舱中,并且在关闭位置,所述筒由所述隔室接收,所述筒舱被配置成在打开位置和关闭位置之间枢转;
壳体,其包括扩展组件,所述扩展组件包括:
驱动器,其由线性稳定器从远端支撑,包括被配置成推向所述壳体的轴承,所述驱动器由马达旋转;
两个中间螺杆,其螺纹连接到所述驱动器;
柱塞驱动器,其螺纹连接到所述两个中间螺杆;和
防旋转引导件,其防止所述柱塞驱动器旋转。
2.根据权利要求1所述的药物释放装置,其中,所述壳体包括限定针罩和药物释放孔的皮肤接触表面。
3.根据权利要求2所述的药物释放装置,其中,所述皮肤接触表面的全部或部分涂覆有粘合剂。
4.根据权利要求1所述的药物释放装置,进一步包括:
注射针,其在扩展位置中垂直于所述筒的流体储存器的纵向轴线;
联接器,其包括空心针;和
柔性管,其连接针头和所述联接器。
5.根据权利要求4所述的药物释放装置,其中,当所述筒被插入到所述筒舱时,所述筒的隔膜被所述空心针刺穿。
6.根据权利要求5所述的药物释放装置,其中,所述扩展组件被配置成将所述筒纵向地推入到所述空心针中以刺穿所述隔膜。
7.根据权利要求4所述的药物释放装置,其中,所述联接器的所述针在所述隔室的一端处被安装到所述药物释放装置,并且所述扩展组件在所述隔室的相对端处被安装到所述药物释放装置。
8.根据权利要求7所述的药物释放装置,其中,所述筒被放置在所述扩展组件和所述联接器之间。
9.根据权利要求7所述的药物释放装置,其中,所述扩展组件被配置成沿与所述筒同轴的扩展轴线扩展。
10.根据权利要求1所述的药物释放装置,其中,所述筒包括注射筒,所述注射筒包括被配置成将所述注射筒保持在所述筒舱中的凸缘。
11.根据权利要求1所述的药物释放装置,进一步包括柱塞密封件,其中,所述柱塞驱动器被配置成移动到所述筒的开口中,直到其接合所述柱塞密封件,并且其中在所述柱塞驱动器接合所述柱塞密封件之后,所述扩展组件的进一步扩展将所述柱塞密封件向远端驱动到所述筒的储存器中。
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JP2018516678A (ja) 2018-06-28
CN113181477B (zh) 2023-07-14
CN107683158B (zh) 2021-05-14
US20180154081A1 (en) 2018-06-07
EP3302652A1 (en) 2018-04-11
EP3302652B1 (en) 2023-09-06
US11207465B2 (en) 2021-12-28
EP4252798A3 (en) 2023-10-25
JP7178458B2 (ja) 2022-11-25
US11931552B2 (en) 2024-03-19
CN107683158A (zh) 2018-02-09
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