CN113226418A - 鼻内压力药物递送设备 - Google Patents
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Abstract
一种有效药剂药物配送设备,包括配送主体,配送主体包括压力腔以及至少一个配送口。柔性的主容器储存有容纳于主体内的有效药剂。这样的布置使得在压力腔内的压力挤压柔性主容器,以通过配送口排出有效药剂。该有效药剂配送器可以被配置为在鼻内递送有效药剂。
Description
相关申请的交叉引用
本申请要求了申请号为62/749,296,申请日为2018年10月23日的美国临时专利申请的优先权,并通过引用将其完全合并至本申请中。
技术领域
本申请公开的内容总体涉及配送组件。更具体地,本申请公开的内容涉及鼻内药物递送设备。
背景技术
鼻内配送器,例如那些用于施予的设备,利用人工力量以产生容纳在设备中的有效药剂的喷雾或喷射流。这会导致配送流特性的潜在变化,取决于多强力地和/或多快速地操作该药物配送器。这种配送流特性的不规则性同样可能导致药物的吸收率和有效性的变化。
先前已知的鼻内配送器采用注射器式外形(例如,活塞和活塞筒的布置)。这种配送器的缺点之一是有效药剂暴露在注射器相关材料如硅或橡胶下会损害有效药剂的稳定性以及药效。玻璃注射器同样会损害设备的耐冲击性。
因此,存在着对于改进的鼻内配送器的需求,该鼻内配送器解决部分或全部的上述问题。
附图说明
图1a是根据一个典型的实施例的鼻内配送器的正视图,显示了配送器处于预激活配置下;
图1b是图1a中的鼻内配送器关于直线1b-1b的横截面图;
图2a是处于激活配置的鼻内配送器的正视图;
图2b是图2a中的鼻内配送器关于直线2b-2b的横截面图;
图3a是具有伸缩体的鼻内配送器的透视图;以及
图3b是图3b中的鼻内配送器的透视图,显示了其盖被取下的情形。
具体实施方式
此处描述了包括主体和至少一个配送口的有效药剂配送器的多个实施例。压力腔位于主体内部。有效药剂被储存在位于主体内部的柔性主容器中。在一些实施例中,主容器可以是由薄膜和箔中的至少一种制成的泡包装。压力腔中的压力挤压主容器导致有效药剂通过配送口排出。压力源使得压力腔施压。在一些实施例中,压力源是一个相对较小的具有可破裂膜的二氧化碳筒。破裂针可位于可破裂膜前方。当破裂针与可破裂膜相对运动时,破裂针刺破可破裂膜。一个带有激活机构的手柄可被用于启动相对运动以刺破二氧化碳筒并施压于压力腔。
主容器可以是柔性或半柔性的包装,包括例如模塑容器、吹塑容器,小囊、小袋,软管或以上的任意组合。
配送口可以为多种应用而配置,包括局部、口部、舌下、眼部、口齿以及吸入。配送口可以是多种形式,包括例如喷射嘴、喷雾嘴、或局部覆抹器例如刷子或海绵。
除了二氧化碳筒以外,其他压力源也可以被采用,包括由化学反应产生压力的压力源。
在一些实施例中,本申请所公开的配送器包括多个主容器,内含相同或不同的有效药剂。在另一些实施例中,主容器包括可以在施用之前被人工地或自动地合并的多个隔间。在一些实施例中,第一隔间包括干燥形态的活性成分,第二隔间包括稀释剂,这两个隔间在施用前被合并且使得两种物质重组并形成有效药剂。本申请所公开的配送器可以包括多个主容器,各个主容器中的内容物均通过一个公共配送口配送。在一些配置中,本申请公开的配送器包括多个主容器,各个主容器中的内容物从不同的配送口配送。
图1a展示了根据此处描述的多个实施例鼻内配送器100。鼻内配送器100可包括主体111、在近端114与主体111附接的盖113,以及激活手柄112。激活手柄112与激活机构102连通(如图1b所示)。
图1b展示了图1a中所示的鼻内配送器100沿直线1b-1b所得到的横截面图。配送器100包括位于主体111内的压力腔110。配送器100还包括二氧化碳筒121,其中,远端与破裂针122相对设置。筒121的远端与可被手柄112操纵的激活机构102连通。活塞125限定了压力腔110的近端,并能够在预激活位置(如图1b所示)与被激活位置(如图2b所示)之间移动。第一主容器123位于压力腔110内部并与活塞125连接。如前文所指出的,尽管图1b展示了单个主容器123,但多于一个的主容器123可位于主体111内部。如图1b所示,主容器123为泡包装,由成形侧、盖侧、平面侧以及固定部124组成。成形侧与盖侧在外围相互密封,并且均密封至固定部124以形成密封空间。固定部124位于活塞125内部的开口中通过密封件126密封。活塞密封件128保持活塞125与主体111之间的密封连接。通气窗127防止在主体111的近端形成压力。在配送器100的近端,从主体111延伸出配送口132(如图1b所示为双卧式鼻覆抹器的形式)。管131在配送口132的内部延伸,并连通在主体111的内部和配送口132的近端之间。盖113向配送口132提供物理保护和无菌空间的至少其中之一。
图2a展示了处于被激活位置的鼻内配送器100。为了达到这个配置,手柄112被转动远离主体111,以将激活机构102向后拉,然后被压向主体111,以使得激活机构102通过破裂针122刺破二氧化碳筒121并向压力腔110施压。移除盖113以露出配送口132。
在图2b中,激活机构102推动二氧化碳筒121,因此破裂针112刺入二氧化碳筒121,使得二氧化碳气体施压于压力腔。压力将活塞125朝向配送器100的近端推动,达到被激活位置,使得管131的远端刺入主容器123,使得压力挤压主容器123并通过配送口132排出容纳于主容器123内的物质。密封件128在通气窗127中显示,意味着设备100已经被激活。
在一些实施例中,当密封件128达到被激活位置时,排气孔打开,使得压力腔110中的气体排尽并减小压力。在一些实施例中,活塞返回弹簧(未示出)被设置于通气腔130(如图1b)中,布置为,当被激活后,在压力腔110中的压力被排尽至一个特定的压力阈值以下时,弹簧力克服由压力腔110中的压力所施加的力,导致活塞125缩回并与活塞密封件128分离。排气孔作为活塞在被激活位置停留时间的计时器,因此较快地排气(例如,较大的排气孔)会更快地减少在压力腔110中的压力并且弹簧会将活塞125更早地拉回。活塞125从预激活位置到被激活位置并返回的移动为配送器100的使用者提供了从开始到结束的触觉。压力腔110中的压力排出为使用者提供了配送过程从开始到结束的听觉。普通技术人员能够知道,多种配送设备能够与配送口的近端适配,例如喷射嘴或喷雾嘴。
图3a和图3b展示了与鼻内配送器100类似的鼻内配送器300,包括伸缩体301。栓绳304的一端与盖303附接,另一端与锁钩305连接。图3a展示了配送器300的主体被折叠的状态,更便于储存。通过握持伸缩体301并将栓绳304向主体301的相反方向拉,伸缩体沿轴向延伸,此时盖305被移开并使配送口321露出,如图3b所示。这样的布置使得伸缩体301的近端覆盖盖的远端,以防盖被移开,直到主体301被延伸。在延伸位置,手柄312可以移动到准备位置以便激活。在栓绳304上印有便于用户训练和操作的信息。主体301的远端通过按颜色编码以将配送器300与其他不同药物的配送器区分开。在类似的实施方式中,栓绳304、盖303以及锁钩305中的至少一个可按颜色编码。此外,主体301的远端302可以具有区别的形状以便识别治疗方法。药物配送器300便于在灵巧度有限或带手套的情况下操作配送器300,因为延伸体301提供了设备的更好的抓持性,具有锁钩305的栓绳304使得握持和拉拽相比直接握持盖303更容易。对于单手操作,锁钩305可以与固定物体附接,例如衣物、旅行箱或背包,主体301的延伸可以仅仅通过拉拽伸缩体301来完成。治疗方法的详情可以印在或附在栓绳304、锁钩305或盖303中的至少一个上。锁钩305可以附接在对象的衣物上以表示该对象已经完成治疗了。
如上文所述,可以理解的是,为了展示的目的,本说明书已经描述了本发明的数个具体实施例,但是在不偏离本发明的目的的前提下可以做出多种改进。因此,本发明并不仅仅由所附的权利要求书所限定。
尽管本技术是用特定于某些结构和材料的语言描述的,可以理解的是由所附的权利要求书中限定的本发明不必然受限于被描述的特定的结构或材料。相反,具体方面被描述为实现所要求保护的发明的形式。由于本发明的许多实施例可以在不脱离本发明的精神和范围的情况下实施,因此本发明存在于所附的权利要求中。
除非另外说明,本说明书(除权利要求书以外)中采用的所有数字以及表达式,例如那些表示尺寸、物理性质等等的数字以及表达式,在所有情况下均被理解为由词语“大约”修饰。至少,且不作为限制本申请中与权利要求同等的声明内容,本说明书以及本权利要求中所引用的每个由词语“大约”修饰的数字参数应当至少根据所引用的有效位数以及应用舍入技术来理解。此外,此处所公开的所有数值范围应当被理解成为那些引用了任一或所有子范围或任一或所有单个数值的权利要求包括及提供支持。例如,范围1至10的表达应当被认为为那些引用了任一或所有介于和/或包括最小值1与最大值10之间的子范围或单个数值的权利要求包括及提供支持;即,所有以最小值1或更大开始,以最大值10或更小结束的子范围(例如,5.5至10,2.34至3.56,以此类推)或任何介于1至10之间的数值(例如,3,5.8,9.9994,以此类推)。
Claims (21)
1.一种有效药剂配送设备,包括:
至少一个存储有效药剂的主容器;
与所述主容器连接的配送主体,包括压力腔以及至少一个配送口,其中所述压力腔的激活使得所述主容器屈伸并通过所述配送口排出所述有效药剂。
2.如权利要求1所述的有效药剂配送设备,其中所述主容器包括泡包装。
3.如权利要求2所述的有效药剂配送设备,其中所述泡包装由薄膜和箔中的至少一个形成。
4.如权利要求1所述的有效药剂配送设备,还包括用于向所述压力腔施压的压力源。
5.如权利要求4所述的有效药剂配送设备,其中所述压力源是二氧化碳筒,所述二氧化碳筒包括可破裂膜以及破裂针。
6.如权利要求5所述的有效药剂配送设备,还包括用于刺破所述二氧化碳筒的激活机构和与所述激活机构连接的手柄。
7.如权利要求1所述的有效药剂配送设备,其中所述主容器包括柔性或半柔性包装。
8.如权利要求7所述的有效药剂配送设备,其中所述主容器包括泡包装、模塑容器、吹塑容器,小囊、小袋,软管中的至少一个或其任意组合。
9.如权利要求1所述的有效药剂配送设备,其中所述配送口包括喷射嘴、喷雾嘴、或局部覆抹器中的至少一个。
10.如权利要求1所述的有效药剂配送设备,其中所述有效药剂配送设备包括储存相同或不同有效药剂的多个主容器。
11.如权利要求1所述的有效药剂配送设备,其中所述至少一个主容器包括多个隔间,其内容物在所述配送设备激活时混合以重组并形成所述有效药剂。
12.如权利要求1所述的有效药剂配送设备,其中所述压力腔包括多个主容器,所述多个主容器中的内容物通过所述至少一个配送口配送。
13.如权利要求12所述的有效药剂配送设备,其中所述多个主容器中的内容物通过一个公共配送口配送。
14.如权利要求1所述的有效药剂配送设备,还包括可移除地附接到所述配送主体的盖。
15.如权利要求1所述的有效药剂配送设备,还包括用于激活所述压力腔的手柄。
16.如权利要求15所述的有效药剂配送设备,还包括与所述压力腔连接的活塞,所述活塞在所述手柄的传动下可从预激活位置移动到被激活位置。
17.如权利要求16所述的有效药剂配送设备,还包括活塞返回弹簧,所述活塞返回弹簧倾向于拉回所述活塞并驱使所述活塞进入所述预激活位置。
18.如权利要求1所述的有效药剂配送设备,还包括管,所述管设置于所述配送口里面,与所述配送主体内部连通。
19.如权利要求1所述的有效药剂配送设备,还包括排气孔以助于调节所述压力腔中的压力。
20.如权利要求14所述的有效药剂配送设备,还包括栓绳和附接到所述盖的锁钩。
21.如权利要求20所述的有效药剂配送设备,其中所述配送主体的至少一部分是可伸缩的,并且其中所述配送主体的近端在收缩配置下覆盖所述盖的远端以防止所述盖被移除,直到所述配送主体被移动到延伸配置。
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US201862749296P | 2018-10-23 | 2018-10-23 | |
US62/749,296 | 2018-10-23 | ||
PCT/US2019/057714 WO2020086752A1 (en) | 2018-10-23 | 2019-10-23 | Intranasal pressure drug delivery device |
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CN113226418A true CN113226418A (zh) | 2021-08-06 |
CN113226418B CN113226418B (zh) | 2023-12-01 |
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US (2) | US11638794B2 (zh) |
EP (1) | EP3870258A4 (zh) |
JP (1) | JP2022505636A (zh) |
CN (1) | CN113226418B (zh) |
WO (1) | WO2020086752A1 (zh) |
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WO2020086752A1 (en) | 2020-04-30 |
US11638794B2 (en) | 2023-05-02 |
US20200121871A1 (en) | 2020-04-23 |
JP2022505636A (ja) | 2022-01-14 |
CN113226418B (zh) | 2023-12-01 |
US20230338675A1 (en) | 2023-10-26 |
EP3870258A4 (en) | 2022-08-10 |
EP3870258A1 (en) | 2021-09-01 |
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