CN104755059A - 液体药物转移装置 - Google Patents
液体药物转移装置 Download PDFInfo
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- 239000003814 drug Substances 0.000 title claims abstract description 321
- 239000007788 liquid Substances 0.000 title claims abstract description 140
- 238000012546 transfer Methods 0.000 title claims abstract description 108
- 229940079593 drug Drugs 0.000 title claims abstract description 30
- 239000012530 fluid Substances 0.000 claims description 23
- 230000000149 penetrating effect Effects 0.000 claims description 15
- 210000002445 nipple Anatomy 0.000 claims description 9
- 238000005452 bending Methods 0.000 claims description 8
- 230000035515 penetration Effects 0.000 claims description 6
- 241000283216 Phocidae Species 0.000 claims description 4
- 230000001737 promoting effect Effects 0.000 claims 2
- 238000003780 insertion Methods 0.000 claims 1
- 230000037431 insertion Effects 0.000 claims 1
- 238000006116 polymerization reaction Methods 0.000 claims 1
- 238000001802 infusion Methods 0.000 abstract description 7
- 238000002347 injection Methods 0.000 abstract description 7
- 239000007924 injection Substances 0.000 abstract description 7
- 238000010586 diagram Methods 0.000 description 29
- 238000007789 sealing Methods 0.000 description 7
- 230000004913 activation Effects 0.000 description 5
- 238000001990 intravenous administration Methods 0.000 description 5
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- 238000005859 coupling reaction Methods 0.000 description 4
- 238000012377 drug delivery Methods 0.000 description 4
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- 239000000463 material Substances 0.000 description 3
- 238000007665 sagging Methods 0.000 description 3
- 230000003213 activating effect Effects 0.000 description 2
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- ORQBXQOJMQIAOY-UHFFFAOYSA-N nobelium Chemical compound [No] ORQBXQOJMQIAOY-UHFFFAOYSA-N 0.000 description 2
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 1
- 229910052782 aluminium Inorganic materials 0.000 description 1
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- 238000004891 communication Methods 0.000 description 1
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- 230000002093 peripheral effect Effects 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 238000009423 ventilation Methods 0.000 description 1
- 239000002699 waste material Substances 0.000 description 1
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Abstract
液体药物转移装置,其具有通用药瓶转接器,用于与小药瓶和大药瓶的药瓶一起使用。一些通用药瓶转接器利用相同的大体上相对的直立的可弯曲部件夹住小药瓶和大药瓶。其它的通用药瓶转接器包括一套用于夹住小药瓶的较小可弯曲部件和一套围绕该套较小可弯曲部件的较大可弯曲部件,该套较大可弯曲部件用于夹住大药瓶,届时,该大药瓶位于该套较小可弯曲部件的下面。液体药物转移装置具有用于附接到输液袋的注入口上的通用注射口接头。
Description
技术领域
本发明涉及液体药物转移装置。
背景技术
液体药物转移装置(liquid drug transfer devices)包括用于伸缩地安装在小药瓶和大药瓶的药瓶上的通用药瓶转接器(universal drug vial adapters),可被划分为下列两种类型中的一种:
第一,通用药瓶转接器,其形状和规格用于伸缩地同样地夹在小药瓶和大药瓶上。典型的现有参考文献尤其包括Poli等的美国专利号5,334,179,Sasso的美国专利号6,656,433,Leinsing的美国专利号6,875,205,以及Fangrow的美国专利号8,469,939。
第二,通用药瓶转接器,其形状和规格仅仅用于伸缩地夹在大药瓶上,并且装备有插入到其中的小瓶耦合转接器,该小瓶耦合转接器的形状和规格仅仅用于伸缩地夹在小药瓶上。Peterson等的美国专利5,893,397公开了一种药瓶/注射器液体转移装置,其包括带有液体药物转移装置(24)和小瓶耦合转接器(26)的液体转移装置(20)。
一些液体药物转移装置被打算安装在含有输注液体的输液袋的注入口上。输液袋的不同供应商提供不同尺寸的注入口。Aalto等的美国专利号4,607,671公开了一种包括用于密封安装在注入部位(34)的塑料外壳(52)的重构装置(10)。该塑料外壳(34)包括刚性管状的双尖针头(54)。
具有用于混合、重构以及给药目的的改进的通用药瓶转接器和改进的注入口接头的液体药物转移装置是很有必要的。
发明内容
本发明的一方面针对的是液体药物转移装置,该液体药物转移装置具有用于伸缩地夹在所谓的小药瓶和所谓的大药瓶的药瓶上的通用药瓶转接器。大药瓶具有与小药瓶相同的形状但是它具有成比例的较大规格。尤其是,大药瓶比它们对应的小药瓶具有更宽直径的药瓶密封和药瓶颈。对于本申请说明书的目的来说,所谓的小药瓶是市场上广泛销售的13mm药瓶,所谓的大药瓶是市场上广泛销售的20mm药瓶。本发明同样地可适用于较大的所谓的小药瓶和含较多液体体积的所谓的大药瓶,例如,分别为28mm直径的药瓶密封和32mm直径的药瓶密封。
根据本发明,一些优选实施例的液体药物转移装置包括通用药瓶转接器,该通用药瓶转接器利用相同的至少一对大体上相对的直立的可弯曲部件(flex members),借助塑料材料,例如聚碳酸酯等,的固有弹性夹住小药瓶和大药瓶,该通用药瓶转接器由这些塑料材料制成。当将通用药瓶转接器伸缩地夹在药瓶上时,该至少一对可弯曲部件弹性地、可弯曲地安装在朝向和药瓶头部相对的药瓶底部的横档(crosspieces)上。该可弯曲部件具有和它们各自的横档相对的可弯曲部件自由端,每个可弯曲部件包括向内径向指向的药瓶抓柄(inward radial directed drug vial grip)。当将通用药瓶转接器伸缩地夹在药瓶上时,该向内径向指向的药瓶抓柄位于药瓶头部的之下。一般来说,与将该通用药瓶转接器伸缩地安装在小药瓶上相比,当将该通用药瓶转接器伸缩地安装在大药瓶上时,该可弯曲部件相对于纵向药瓶转接器轴相应地在它们的横档处向外地弹性弯曲更大程度。
根据本发明,其它优选实施例的液体药物转移装置包括通用药瓶转接器,该通用药瓶转接器利用一套较小可弯曲部件(a set of minor flex members)伸缩地夹住小药瓶,利用围绕该套较小可弯曲部件的一套较大可弯曲部件(a set of major flex members)伸缩地夹住大药瓶,届时,大药瓶位于该套较小可弯曲部件的之下。该套较大可弯曲部件优选地被布置使得当伸缩地夹在小药瓶上时,该套较小可弯曲部件相对于纵向药瓶转接器轴自由地向外弯曲,没有来自该套较大可弯曲部件的干扰。
许多各种不同的液体药物转移装置可与本发明的通用药瓶转接器一起形成用于不同的液体药物转移目的。该通用药瓶转接器可选择地以通气形式或不通气形式(ventedand unvented version)形成。一些液体药物转移装置可包括整体进入口和整体刺穿部件,该整体刺穿部件用来当伸缩地夹住药瓶时刺穿药瓶塞以能够与其内部流体连通。此类液体药物转移装置尤其包括带有母鲁尔接头(female Luer connector)的母药瓶转接器(afemale drug vial adapter),包括公鲁尔接头(male drug vial adapter)的公药瓶转接器(maleLuer connector)等。
其它的液体药物转移装置可以是所谓的待使用的医疗装置,其包括预附接的未开启的,即未被刺穿的药瓶。此类液体药物转移装置可包括具有在致动时用于刺穿药瓶的刺穿部件的分离式液体转移部件。本发明的通用药瓶转接器优选被设计使得未开启的药瓶通过药瓶释放工具(drug vial release tool)很容易被释放用于随后的使用,从而避免可能的药物浪费。未开启的药瓶无需庞大的液体药物转移装置可放回到适当的储存条件。
本发明的另一方面针对的是带有用于附接到常规输液袋的注入口的通用注入口接头(universal injection port connector)的液体药物转移装置。常规注入口包括具有尾随注入口末端边缘(trailing injection port tip rim)的注入口末端(injection port tip),该尾随注入口末端边缘设置在自动密封的塞的暴露的塞表面的后面用于注射器内容物到输液袋中的针注射注入。该通用注入口接头包括多个弯曲连接器部件(curved connectormembers),当用力向内插入注入口末端通过弯曲连接器部件时,该弯曲连接器部件从它们的非弯曲位置被向外地推动使得该多个弯曲连接器部件在后面咬住尾随注入口末端边缘,从而阻止该注入口末端从该通用注入口接头的滑动拔出。与直连接器部件相比,本发明的通用注入口接头的连接器部件借助它们的弯曲形状能够抵制更大的拔出力。此外,该弯曲连接器部件便于安装在不同尺寸的注入口上,典型地,不同供应商的输液液体容器。
附图说明
为了理解本发明且看清楚如何在实践中实施它,仅仅借助非限制性实施例,参照附图描述优选的实施例,附图中相同的部分采用了同样的编号,并且其中:
图1是注射器、小药瓶、大药瓶以及根据本发明的第一优选实施方式的液体药物转移装置的示图。
图2是图1的液体药物转移装置的正透视图;
图3是图1的液体药物转移装置的后透视图;
图4A是图1的液体药物转移装置的右侧正视图;
图4B是图1的液体药物转移装置沿图4A中的A-A线的纵向截面图;
图5A是图1的液体药物转移装置的正视图;
图5B是图1的液体药物转移装置沿图5A中的B-B线的纵向截面图;
图6是图1的液体药物转移装置伸缩地夹在小药瓶上的正视图;
图7是图6的组合件沿其上的C-C线的纵向截面图;
图8是图1的液体药物转移装置伸缩地夹在大药瓶上的正视图;
图9是图8的组合件沿其上的D-D线的纵向截面图;
图10是显示注射器从图6的组合件中抽吸液体内容物的示图;
图11是显示注射器从图8的组合件中抽吸液体内容物的示图;
图12是根据本发明的第二优选实施例的液体药物转移装置的纵向截面图;
图13是在流体连通位置的图12的液体药物转移装置的纵向截面图;
图14是根据本发明的第三优选实施例的液体药物转移装置的示图;
图15是根据本发明的第四优选实施例的液体药物转移装置和输液液体容器的示图;
图16是图15的液体药物转移装置的分解图;
图17A是在初始的预致动位置的图15的液体药物转移装置沿着图15中的E-E线的纵向截面图;
图17B是在刺穿药瓶的中间位置的图15的液体药物转移装置沿着图15中的E-E线的纵向截面图;
图17C是在刺穿输液液体容器的致动位置的图15的液体药物转移装置沿着图15中的E-E线的纵向截面图;
图18A是药瓶释放工具在其组装位置的正视图;
图18B是图18A的药瓶释放工具沿着其上的F-F线的纵向截面图;
图19A是药瓶释放工具在其操作瓶释放位置(operative vial release position)释放药瓶的正视图;
图19B是图19A的药瓶释放工具沿着其上的G-G线的纵向截面图;
图20A是药瓶释放工具在其组装位置安装在带有预附接的未开启的药瓶的图15的液体药物转移装置上的正视图;
图20B是图20A的组合件沿其上的H-H线的纵向截面图;
图21A是药瓶释放工具在其操作瓶释放位置安装在带有预附接的未开启的药瓶的图15的液体药物转移装置上的正视图;
图21B是图21A的组合件沿其上的I-I线的纵向截面图;
图22A是安装在图15的液体药物转移装置和分离式未开启的药瓶上的药瓶释放工具的正视图;
图22B是图22A的组合件沿其上的J-J线的纵向截面图;
图23A是安装在带有被刺穿的药瓶的图15的液体药物转移装置上的药瓶释放工具在局部手动致动旋转之后的不操作位置的正视图;
图23B是图23A的组合件沿其上的K-K线的纵向截面图;
图24是根据本发明的第五优选实施例的液体药物转移装置的前顶透视图;
图25是图24的液体药物转移装置的正视图;
图26是图24的液体药物转移装置的右侧正视图;
图27是图24的液体药物转移装置沿图26上的L-L线的纵向截面图;
图28是伸缩地夹在小药瓶上的图24的液体药物转移装置的右侧正视图;
图29是图28的组合件沿其上的M-M线的纵向截面图;
图30是安装在大药瓶上的图24的液体药物转移装置的正视图;
图31是图30的组合件沿其上的N-N线的纵向截面图;
图32是显示注射器从图28的组合件中抽吸液体内容物的示图;
图33是显示注射器从图30的组合件中抽吸液体内容物的示图;
图34是用于附接到注入口的常规液体药物转移装置的前透视图;
图35是与用于附接到注入口的常规注入口接头一起部署的图34的液体药物转移装置沿其上的O-O线的纵向截面图;
图36是图35的常规注入口接头的俯视图;
图37是根据本发明的通用注入口接头的透视图;
图38是图37的通用注入口接头沿其上的P-P线的纵向截面图;
图39是带有所谓的小注入口的输液袋的前透视图;
图40是图34的液体药物转移装置的纵向截面图,其带有安装在图39的小注入口上的图37的通用注入口接头;
图41是带有所谓的大注入口末端的输液袋的前透视图;
图42是图34的液体药物转移装置的纵向截面图,其具有安装在图41的大注入口上的图37的通用注入口接头。
具体实施方式
图1显示了注射器10,小药瓶20A,大药瓶20B和药物转移装置100,该药物转移装置100构成与注射器10和小药瓶20A和大药瓶20B的药瓶20一起使用的母小瓶转接器。
注射器10包括具有活塞杆12的桶11和公鲁尔锁接头13。注射器10可与其它类型的公接头例如,滑动鲁尔接头等一起形成。典型地,注射器10填装有稀释液。或者,注射器10可包括活性液体成分。
药瓶20具有纵向药瓶轴21,并且包括具有药瓶底部23的药瓶身22,限定药瓶开口26的药瓶头部24,和在药瓶身22和药瓶头部24之间的狭窄直径药瓶颈部27。药瓶20具有存储粉末或液体药剂29的药瓶内部28。药瓶20由插入药瓶开口26的药瓶塞子31密封。药瓶塞子31具有最上药瓶表面32。药瓶20由例如,铝带等构成的药瓶封闭物33气密封。
广泛市售可得的小药瓶20A具有药瓶封闭物33,药瓶封闭物33的外径D1为13mm至14mm之间,广泛市售可得的大药瓶20B具有药瓶封闭物33,药瓶封闭物33的外径为D2,D2>D1,典型地,D2为20mm至21mm之间。
图1到图11显示液体药物转移装置100包括通用药瓶转接器200A和用于与注射器公鲁尔锁接头13接合的母鲁尔接头101。液体药物转移装置100包括管状刺穿元件102,管状刺穿元件102与母鲁尔接头101流体连通用于使流体能够进入药瓶内部28。
通用药瓶转接器200A具有纵向药瓶转接器轴201和用于限定药瓶腔203的裙边202。药瓶腔203用于紧密地伸缩地至少接收在其内的药瓶20B的顶部部分,并且因此内在地接收药瓶20A的顶部部分。裙边202包括由环形中心部分206构成的顶壁204,环形中心部分206具有第一对两个径向指向的支杆207和第二对两个径向指向的支杆208。环形中心部分206与直立的母鲁尔接头101一起形成。
裙边202包括第一对轴向指向的分开的可弯曲部件支撑物(flex member supports)209和211,它们从径向指向的支杆207开始向下下垂。裙边202包括第二对轴向指向的分开的可弯曲部件支撑物212和213,它们从径向指向的支杆208开始向下下垂。第一对轴向指向的可弯曲部件支撑物209和211和第二对轴向指向的可弯曲部件支撑物212和213相对。
可弯曲部件支撑物209具有邻近顶壁204的近端209A和远离顶壁204的远端209B。可弯曲部件支撑物211具有邻近顶壁204的近端211A和远离顶壁204的远端211B。可弯曲部件支撑物212具有邻近顶壁204的近端212A和远离顶壁204的远端212B。可弯曲部件支撑物213具有邻近顶壁204的近端213A和远离顶壁204的远端213B。
裙边202包括单个连续的环形支持物214,该支持物214包括在远端209B和211B之间延伸的第一横档(a first crosspiece)216,在远端212B和213B之间延伸的第二横档217,在远端209B和212B之间延伸的第三横档218,在远端211B和213B之间延伸的第四横档219。
裙边202包括弹性地可弯曲地安装在第一横档216上的轴向指向的第一可弯曲部件221,弹性地可弯曲地安装在第二横档217并且和第一可弯曲部件221相对的轴向指向的第二可弯曲部件222,弹性地可弯曲地安装在第三横档218并且在第一可弯曲部件221和第二可弯曲部件222之间的轴向指向的第三可弯曲部件223,弹性地可弯曲地安装在第四横档219并且和第三可弯曲部件223相对的轴向指向的第四可弯曲部件224。
第一可弯曲部件221具有远离第一横档216的第一可弯曲部件自由端221A和朝向第一可弯曲部件自由端221A的向内径向指向的的第一药瓶抓柄(drug vial grip)221B。第二可弯曲部件222具有远离第二横档217的第二可弯曲部件自由端222A和朝向第二可弯曲部件自由端222A的向内径向指向的的第二药瓶抓柄222B。第三可弯曲部件223具有远离第三横档218的第三可弯曲部件自由端223A和朝向第三可弯曲部件自由端223A的向内径向指向的第三药瓶抓柄223B。第四可弯曲部件224具有远离第四横档219的第四可弯曲部件自由端224A和朝向第四可弯曲部件自由端224A的向内径向指向的第四药瓶抓柄224B。
第一药瓶抓柄221B和第二药瓶抓柄222B限定它们之间的间距S,其中S<D1,同样地,第三药瓶抓柄223B和第四药瓶抓柄224B限定它们之间的间距S,使得伸缩地夹住它们上面的液体药物转移装置100时,它们位于药瓶20A的药瓶封闭物33之下。由于D2>D1,药瓶抓柄221B、222B、223B和224B也在药瓶20B的药瓶封闭物33之下。
在将液体药物转移装置100伸缩地夹在药瓶20A上之前,可弯曲部件221、222、223和224大体上平行于纵向药瓶转接器轴201。在将液体药物转移装置100伸缩地夹在药瓶20A上时,随着药瓶封闭物33在顶壁204下面从药瓶抓柄221B、222B、223B和224B下方穿过到达这些抓柄上方,可弯曲部件221、222、223和224在它们各自的横档216、217、218和219处相对于纵向药瓶转接器轴向外弹性地弯曲,届时,可弯曲部件221、222、223和224恢复到大体上平行于纵向药瓶转接器轴201,如图6和7的虚线A所示。
在将液体药物转移装置100伸缩地夹在药瓶20B上的情况下,与药瓶20A相比较,可弯曲部件221、222、223和224相对于纵向药瓶转接器轴201在它们各自的横档216、217、218和219处进一步向外弹性地弯曲,这是因为前者20B比后者20A具有宽直径的药瓶封闭物33。在药瓶20B的情况下,可弯曲部件221、222、223和224不能完全地恢复到大体上平行于药瓶转接器轴201,而是相对于它们的原始没有弯曲的位置保持向外地弯曲,如图8和9的虚线B所示。
图10显示注射器10附接到安装在药瓶20A上的液体药物转移装置100,用于混合、重构和抽吸目的。
图11显示注射器10附接到安装在药瓶20B上的液体药物转移装置100,用于混合、重构和抽吸目的。
图12和13显示液体药物转移装置110包括通用药瓶转接器200B,并且被打算和分离式双端液体转移部件111一起使用,分离式双端液体转移部件111与母鲁尔接头112和与母鲁尔接头112流体连通的刺穿插管113一起形成。液体药物转移装置110在结构上类似于液体药物转移装置100,不同之处在于液体药物转移装置110的通用药瓶转接器200B具有与环形中心部分206一起形成的顶壁204,和用于将液体转移部件111保持在环形中心部分206之上的准备好致动的保持布置(a retainer arrangement)226。刺穿插管113由护套114覆盖,护套114维持储存期间的无菌条件并且用做与药瓶20一起使用的密封部件。通过向下按压液体转移部件111,液体转移部件110可伸缩地安装在药瓶20上准备好随后的致动。
附图14显示Zinger等人共同拥有的美国专利6,238,372公开的液体药物转移装置120,其包括流体控制装置121和用于螺纹啮合到流体控制装置121上的通用药瓶转接器200C。
图15到图17显示液体药物转移装置130用于和典型的显示为静脉注射袋(IV bag)的输液流体容器40一起使用。静脉注射袋40包括注入口41,给药口42和液体容器43。静脉注射袋口41和42是塑料管形式。注入口41终止在包括自封塞46的注入口末端(injection port tip)44,自封塞46具有外露塞表面47被打算用于注射器内容物针头注入静脉注射袋40中。注入口末端44具有尾随注入口末端边缘48。给药口42代表性地由旋盖(a twist off cap)49密封,给药口42用于插入静脉注射尖状物以实现给药目的。
液体药物转移装置130具有纵向液体药物转移装置轴131,并且包括注入口转接器132,双端液体转移部件133和通用药瓶转接器200D。注入口转接器132优选地装备有用于附接到注入口41上的通用注入口接头250。液体转移部件133装备有针头134,针头134用于刺穿注入口41,并且终止在用于刺穿药瓶塞子31的刺穿尖端(puncturing tip)136。针头134由护套134A保护,刺穿尖端136由护套(sheath)136A保护。
液体转移部件133与前导钻孔样头(leading drill like bit)137和尾随成对的向外指向的插脚(pins)138一起形成。通用药瓶转接器200D不同于通用药瓶转接器200A之处在于通用药瓶转接器200D具有顶壁204,顶壁204与环形中心部分206上的轴向指向的管状杆227一起形成。杆227具有一对相对的大体上螺旋形的轨道228,轨道228用于由该对向外的径向插脚138相应地啮合。每个轨道228具有远离顶壁204的开始轨道端228A和邻近顶壁204的最终轨道端228B。
钻孔样头137具有前导塞子139A和尾随塞子139B。注入口转接器132具有与向内径向指向的前导法兰142A和向内指向的尾随法兰142B一起形成的内表面141。
图17A显示在液体药物转移装置130的起始预致动位置前导塞子139A安置在前导法兰142A上。刺穿尖端136部署在顶壁204上面或在顶壁204处,使得未开启的药瓶20可伸缩地被夹在通用药瓶转接器200D中以随后使用。在将药瓶伸缩地安装在通用药瓶转接器200D中时,刺穿尖端136与其最上药瓶表面32分开。液体药物转移装置130具有在其起始预致动位置的高度H1。
图17B显示围绕纵向轴131在顺时针拧紧方向上(如图15中箭头A所示)起始手动致动旋转通用药瓶转接器200D,导致通用药瓶转接器200D沿液体转移部件133移动直到向外指向的插脚138停止在最终轨道端228B。该线性移动致使刺穿尖端136刺穿通过药瓶塞子31进入预先被夹住的药瓶20的药瓶内部28用于建立和其药瓶内部28的流体连通。液体药物转移装置130在其中间药瓶刺穿位置具有高度H2,其中H2<H1。
图17C显示在相同的顺时针拧紧方向上继续手动致动旋转通用药瓶转接器200D导致液体转移部件133和通用药瓶转接器200D的联合移动直到尾随塞子141B贴紧尾随法兰142停止。该线性移动促使针头134朝向通用注入口接头250用于刺穿注入口41,由此建立输液液体容器40和药瓶20之间的流体连通。液体药物转移装置130具有在其致动的输液液体容器刺穿位置的高度H3,其中H3<H2。
液体药物转移装置130优选地装备有预附接未开启药瓶20。可选择地,液体药物转移装置130可预附接到输液液体容器40。因此,建立输液液体容器和药瓶之间的流体连通要求使用者执行单个手动致动旋转。
图18到图23显示在经历手动致动旋转之前,药瓶释放工具300,在其起始组装状态用于从液体药物转移装置130上释放未开启的药瓶。参考药瓶20B,药瓶释放工具300的结构和操作被显示,药瓶释放工具300的结构和操作同样适用于药瓶20A。
药瓶释放工具300具有纵向工具轴301,并且包括具有外围壁303、底部壁304和顶部边缘306的开顶式外壳302。外壳302被打算滑动接收具有预附接的未开启药瓶20的通用药瓶转接器200D。外周壁303具有内表面307,内表面307有具有四个纵向指向的插槽308用于滑动地接收四个均匀分开的向下下垂的可弯曲部件支撑物209、211、212和213,用于保证药瓶释放工具300中的通用药瓶转接器200D的正确的旋转对齐。每个纵向指向的插槽308与塞子309一起形成,塞子309用于使通用药瓶转接器200D进入药瓶释放工具300的滑动插入停止使得未开启的药瓶20在内部底部壁304之上的高度H4(参见图20B)。在手动致动旋转液体药物转移装置130的情况下,通用药瓶转接器132阻止通用液体药物转接器200D完全插入药瓶释放工具300,如图23A和图23B所示,其中被刺穿的药瓶在底部壁304之上的高度H5。
外壳302与四个纵向指向的矩形开口311一起形成,将通用药瓶转接器200D滑动插入到外壳302中时,矩形开口311定位四个弹性可弯曲的向上垂的可弯曲部件221、222、223和224。药瓶释放工具300包括围绕外壳302的环形栏杆312。栏杆312支撑四个枢轴释放部件313,每个释放部件313具有释放部件边缘314。释放部件313具有能够使通用药瓶转接器200D自由滑动插入到外壳302的组装位置(参见图20A和20B)。释放部件313可操作到操作位置使得它们的释放部件边缘314安置在顶壁204和可弯曲的可弯曲部件221、222、223和224之间的间隔中(参见图21A和21B)。释放部件313被手动操作以相对于纵向工具轴301向外弯曲可弯曲部件221、222、223和234,由此释放下降到底部壁304上的药瓶20(参见图22A和22B)。
图23A和图23B显示在液体药物转移装置130被部分致动刺穿药瓶20的情况下,在将通用药瓶转接器200D插进药瓶释放工具300时,通用药瓶转接器200D停留在顶部边缘306上,释放部件313不与顶壁204和可弯曲部件221、222、223和224之间的间隔对齐,而是它们的释放部件末端314直接面向可弯曲部件221、222、223和224,因此,不可被操作以释放被刺穿的药瓶20.
图24到图33显示液体药物转移装置150与注射器10,小药瓶20A和大药瓶20B的药瓶一起使用。液体药物转移装置150与液体药物转移装置100的相似之处在于它包括通用药瓶转接器200E,母鲁尔接头101和管状刺穿部件102,刺穿部件102与母鲁尔接头101流体连通用于能够使流体进入药瓶内部28。通用药瓶转接器200E与通用药瓶转接器200A的相似之处在于它具有纵向的药瓶转接器轴201,裙边202,药瓶腔203和横向于纵向药瓶转接器轴201的顶壁204,药瓶腔203用于紧密地可伸缩地至少接收在其中的药瓶20B的顶部部分,因此内在地接收药瓶20A的顶部部分。
刺穿部件102具有一对细长流体孔151,每个孔具有邻近顶壁204的近端152A和邻近刺穿尖端153的远端152B。在倒置液体药物转移装置150和药瓶20A的组合件时,近端152A邻近顶壁204以保证药瓶20A的全部液体内容物能从中吸出。远端152B邻近刺穿尖端153以保证液体药物转移装置150和药瓶20B的组合件中刺穿部件102与药瓶20B的药瓶内部28流体连通。
液体药物转移装置150包括覆盖刺穿部件102的薄护套154。在将液体药物转移装置150安装在药瓶20A和药瓶20B上时,薄护套154被促使朝向顶壁204。在前者情况下,图29显示护套在顶壁204和药瓶20A的最上药瓶表面32之间是扁平的。在后者情况下,图31显示护套154在顶壁204和药瓶20B的最上药瓶表面32之间呈波纹样形状。护套154充当密封细长流体孔151的近端152A的密封部件,近端152A暴露在顶壁204和药瓶20B的最上药瓶表面32之间。
裙边202包括用于伸缩地夹在药瓶20A的药瓶头部上的一套较小可弯曲部件(flexmembers)230。该套较小的可弯曲部件230包括用于伸缩地夹在药瓶20A的药瓶头部上的一对相对的较小可弯曲部件231A和231B。每个较小可弯曲部件231具有远离顶壁204的自由较小的可弯曲部件端232A和232B和用于卡扣安装在药瓶20A的药瓶头部24上的向内指向的边缘233A和233B。
裙边202包括用于伸缩地夹在药瓶20B的药瓶封闭物33上的一套较大可弯曲部件234。该套较大可弯曲部件234包括第一对邻近的较大可弯曲部件236A和236B和与第一对邻近的较大可弯曲部件236A和236B相对的第二对邻近的较大可弯曲部件237A和237B。该套较大可弯曲部件234包括成对邻近的较大可弯曲部件236和237用于确保它们夹住药瓶20B的药瓶封闭物33外围的两个相对的较大长段。
每个较大可弯曲部件236和237与纵向指向的窗口238和向内指向的边缘239一起形成用于卡扣安装在药瓶20B的药瓶封闭物33上。较大可弯曲部件236A和237A是分开的以留出在它们之间的间隔241A。较大可弯曲部件236B和237B是分开的以留出在它们之间的间隔241B。较小可弯曲部件231与间隔241对齐,由此在将液体药物转移装置150伸缩地夹在药瓶20A上时,较小可弯曲部件231不受较大可弯曲部件236和237的影响,相对于纵向的药瓶转接轴201向外地弯曲。
图28和29显示液体药物转移装置150安装在药瓶20A上。刺穿部件102完全刺穿过它的药瓶塞子31使得近端152A在药瓶内部28里面。
图30和31显示液体药物转移装置150安装在药瓶20B上。该套较小可弯曲部件230充当接合部件使药瓶20B远离顶壁204,届时,药瓶20B的最上药瓶表面32位于较小可弯曲部件自由端232A和232B之下。
刺穿部件102的顶部部分保持暴露在顶壁204和药瓶的最上药瓶表面32之间。护套154在顶壁204和药瓶20B的最上药瓶表面32之间呈波纹样形状用于充当细长流体孔151的暴露的长段的密封部件。
图32显示注射器10附接到安装在药瓶20A上的液体药物转移装置150上用于混合、重构和抽吸目的。
图33显示注射器10附接到安装在药瓶20B上的液体药物转移装置150上用于混合、重构和抽吸目的。
图34显示带有用于安装在特定尺寸的注入口41上的注入口接头230的液体药物转移装置160,注入口41具有带有自密封塞46,暴露的塞表面47和尾随注入口末端边缘48的注入口末端44。该液体药物转移装置从巴克斯特医疗保健公司(Baxter HealthcareCorporation)用商品名VIAL-MATE转接器装置(VIAL-MATE Adaptor Device)可购买得到。产品清单可在线得到http://www.baxtermedicationdeliveryproducts.com/drug-delivery/vialmate.html.
该产品清单指出VIAL-MATE转接器装置仅仅适合于具有20mm密封的单次剂量小瓶,并指出VIAFLEX容器也可以从巴克斯特医疗保健公司得到。
图35显示液体药物转移装置160包括开口的外壳161,外壳161具有纵向的外壳轴162,进入孔163和小瓶转接器164。开口的外壳161包括用于刺穿注入口41的针头166和向下垂进入与针头166流体连通的小瓶转接器164的刺穿部件167。
图36显示朝向进入孔163部署在开口的外壳161内的常规注入口接头230。注入口接头230包括与纵向外壳轴162同轴对齐的纵向的接头轴231。注入口接头230包括限定横向于纵向外壳轴162的水平面233的圆形支撑环232。支撑环232包括多个直的连接器部件234,每个连接器部件234都终止在朝向纵向外壳轴162布置的自由连接器部件端236。自由连接器部件端236聚合以限定位于水平面233之下的大体上圆形的接头孔237。接头孔237具有连接器孔径D4,其中D4<D3。
液体药物转移装置160经设计以使特定尺寸的注入口41从进入孔163朝向小瓶转接器164的方向被用力滑动插入通过接头孔237,届时自由连接器部件端236在后面咬住尾随注入口末端边缘48。但是,令人不想看到的情况是在进入孔163方向上施加相当小的向外的纵向拔出力时,注入口41能够很容易被从开口外壳161中拔出。
图37和38显示用于安装在不同尺寸的注入口41上的通用注入口接头250。通用注入口接头250具有和注入口接头230相同的基本结构:通用注入口接头250具有纵向轴251,限定水平面253的闭合支撑环252,多个连接器部件254,每个连接器部件254弹性地可弯曲地安装在支撑环252上,并且终止在自由连接器部件端256,连接器部件端256朝向平行于水平面253的接头孔257聚合。优选地,闭合的支撑环252是圆形,但是可以呈其它闭合形状,例如,椭圆形等。
通用注入口接头250不同于常规注入口接头230之处在于与后者的直的连接器部件234不同,前者具有弯曲的连接器部件254,以致通用注入口接头250呈整体碗状形状。接头孔257具有接头孔经D5,其中D5<D3,使得注入口末端44从支撑环252方向上的用力滑动插入通过接头孔257使连接器部件254从它们的非弯曲位置相对于纵向连接器轴251向外弯曲以用于在后面卡扣尾随注入口边缘48,由此阻止在与用力滑动插入相反的方向上滑动拔出注入口末端44。由于其连接器部件254的弯曲形状,通用注入口接头250能够被附接在不同尺寸的注入口41。并且,由于其弯曲的连接器部件254,通用注入口接头250比常规注入口接头230更能够抵挡向外的纵向拔出力。
图39显示静脉注射袋40A具有所谓的小注入口41A,小注入口41A具有带有自密封塞46A,暴露的塞表面47A,和尾随注入口末端边缘48的注入口末端44A。注入口41A具有外直径D11。注入口末端44A具有外末端直径D12和末端高度H11。尾随注入口末端边缘48A具有外直径D13。D11是6.5mm,D12是7.5mm,H11是7.5mm和D13是10.5mm。
图40显示液体药物转移装置160带有附接到小注入口41A的通用注入口接头250。
图41显示输液袋40B具有所谓的大注入口41B,大注入口41B具有和小注入口41A相同的结构,但是具有如下的较大规格:注入口41B具有外直径D21。注入口末端44B具有外末端直径D22和末端高度H21。尾随注入口末端边缘48B具有外直径D23。D21是10.5mm,D22是10.5mm,H21是10mm和D23是13mm。
图42显示液体药物转移装置160带有附接在大注入口41B上的通用注入口接头250。将液体药物转移装置160附接到注入口41B上比附接到注入口41A上时,连接器部件254更加急剧地倾斜,因为前者41B具有比后者41A的注入口直径D11更宽的注入口直径D21。
虽然本发明已经对有限数目的实施例进行了描述,应该认识到,许多变化、修改及本发明的其它应用都可在权利要求书的范围内做出。
Claims (13)
1.一种液体药物转移装置,其用于与小药瓶和大药瓶的药瓶一起使用,所述药瓶包括药瓶身、药瓶内部、药瓶塞子、最上药瓶表面和药瓶封闭物,
所述小药瓶具有外直径为D1的药瓶封闭物,所述大药瓶具有外直径为D2的药瓶封闭物,其中D2>D1。
所述液体药物转移装置包括通用药瓶转接器,该通用药瓶转接器具有纵向药瓶转接器轴和用于伸缩地夹在药瓶封闭物上的裙边。
所述裙边包括横向于所述纵向药瓶转接器轴的顶壁,第一对轴向指向的分开的可弯曲部件支持物和第二对轴向指向的分开的可弯曲部件支持物,所述第二对可弯曲部件支持物和所述第一对轴向指向的可弯曲部件支持物相对,用于限定药瓶腔,所述药瓶腔用于紧密地伸缩地至少接受在其中的大药瓶的顶部部分,
每个可弯曲部件支持物具有邻近所述顶壁的近端和远离所述顶壁的远端,
所述第一对可弯曲支撑部件包括在它们的相应远端之间延伸的第一横档,所述第一横档与相对于所述纵向药瓶转接器轴弹性地可弯曲地安装在其上的轴向指向的第一可弯曲部件一体形成,所述第一可弯曲部件具有远离所述第一横档的第一可弯曲部件自由端和朝向所述第一可弯曲部件自由端的向内径向指向的第一药瓶抓柄,
所述第二对可弯曲支撑部件包括在它们的相应远端之间延伸的第二横档,所述第二横档与相对于所述纵向药瓶转接器轴弹性地可弯曲地安装在其上的轴向指向的第二可弯曲部件一体形成,所述第二可弯曲部件具有远离所述横档的第二可弯曲部件自由端和朝向所述第二可弯曲部件自由端的向内径向指向的第二药瓶抓柄,
所述第一可弯曲部件和所述第二可弯曲部件相对,使得所述第一药瓶抓柄和所述第二药瓶抓柄限定它们之间的间距S,其中S<D1,届时,当将所述通用药瓶转接器伸缩地夹在所述药瓶上时,所述第一药瓶抓柄和所述第二药瓶抓柄位于药瓶封闭物之下,
与将所述通用药瓶转接器伸缩地夹在所述小药瓶上相比,在将所述通用药瓶转接器伸缩地夹在所述大药瓶上时,所述第一可弯曲部件和所述第二可弯曲部件相应地在所述第一横档和所述第二横档处相对于所述纵向药瓶转接器轴向外地弹性地弯曲更大程度。
2.根据权利要求1所述的装置,其中所述裙边包括单个连续环形支撑物,所述环形支持物包括所述第一横档、所述第二横档、在所述第一横档和所述第二横档之间延伸的第三横档,和在所述第一横档和所述第二横档之间延伸,并且和所述第三横档相对的第四横档,
所述第三横档与相对于所述纵向药瓶转接器轴弹性地可弯曲地安装在其上的轴向指向的第三可弯曲部件一起整体形成,所述第三可弯曲部件具有远离所述第三横档的第三可弯曲部件自由端和朝向所述第三可弯曲部件自由端的向内径向指向的第三药瓶抓柄,和
所述第四横档与相对于所述纵向药瓶转接器轴弹性地可弯曲地安装在其上的轴向指向的第四可弯曲部件一起整体形成,所述第四可弯曲部件具有远离所述第四横档的第四可弯曲部件自由端和朝向所述第四可弯曲部件自由端的向内径向指向的第四药瓶抓柄,
所述第三可弯曲部件和所述第四可弯曲部件相对,使得所述第三药瓶抓柄和所述第四药瓶抓柄限定所述它们之间的间距S,届时,当将所述通用药瓶转接器伸缩地夹在所述药瓶上时,所述第三药瓶抓柄和所述第四药瓶抓柄位于所述药瓶封闭物之下。
3.根据权利要求1或2所述的装置,其中所述顶部表面由环形中心部分和从所述环形中心部分到每个所述可弯曲部件支撑物的径向支杆构成。
4.根据权利要求1到3任一项所述的装置,其中在将所述通用药瓶转接器伸缩地夹在药瓶上之前,所述可弯曲部件大体上平行于所述纵向药瓶转接器轴,使得所述第一可弯曲部件和所述第二可弯曲部件,当将所述通用药瓶转接器夹在小药瓶上时大体上平行于所述纵向药瓶转接器轴,当将所述通用药瓶转接器伸缩地安装在大药瓶上时相对于所述纵向药瓶转接器轴向外地弯曲。
5.根据权利要求1到4任一项所述的装置,其中所述顶壁包括整体进入口和与所述整体进入口流体连通的整体刺穿部件,所述整体刺穿部件用于在将所述通用药瓶转接器伸缩地夹在所述药瓶上时刺穿药瓶塞子以能够与所述药瓶内部流体连通。
6.根据权利要求1到4任一项所述的装置,其中所述通用药瓶转接器能够伸缩地夹在预附接的最初未开启的药瓶上,所述顶壁包括覆盖在所述预附接的最初未开启的药瓶的最上药瓶表面上的轴向指向的管状杆,
所述液体药物转移装置进一步包括具有刺穿尖端的分离式液体转移部件,所述刺穿尖端置于所述杆内,用于当朝向所述药瓶向下推动所述液体转移部件刺穿所述药瓶塞子以能够与所述药瓶内部流体连通。
7.根据权利要求6所述的装置,其中所述预附接未开启药瓶,在利用药瓶释放工具相对于所述纵向药瓶转接器轴向外地弯曲所述可弯曲部件时,从所述通用药瓶转接器上是可去除的未开启的。
8.一种液体药物转移装置,其用于与小药瓶和大药瓶的药瓶一起使用,所述药瓶包括药瓶瓶身、药瓶内部、药瓶塞子、最上药瓶表面和药瓶封闭物,
所述小药瓶具有外直径为D1的药瓶封闭物,大药瓶具有外直径为D2的药瓶封闭物,其中D2>D1,
所述液体药物转移装置包括通用药瓶转接器,该通用药瓶转接器具有纵向药瓶转接器轴和用于伸缩地夹在药瓶上的裙边,
所述裙边包括横向于所述纵向药瓶转接器轴的顶壁,
一套轴向指向的较小可弯曲部件,其从所述顶壁向下垂用于伸缩地安装在小药瓶的药瓶封闭物上,所述第一套轴向指向的较小可弯曲部件的每一个都具有远离所述顶壁的自由较小可弯曲部件端,和
一套轴向指向的较大可弯曲部件,其从所述顶壁向下垂并且环绕所述套轴向指向的较小可弯曲部件,用于伸缩地安装在大药瓶的药瓶封闭物上,届时,所述大药瓶的最上药瓶表面位于所述较小可弯曲部件自由端之下。
9.根据权利要求8所述的装置,其中所述套轴向指向的较大可弯曲部件与所述套轴向指向的较小可弯曲部件是正交的,由此,当将所述通用药物转接器伸缩地安装在小药瓶上时,所述套轴向指向的较小可弯曲部件相对于所述纵向药瓶转接器轴在所述套轴向指向的较大可弯曲部件之间向外地弯曲。
10.根据权利要求9所述的装置,其中所述套轴向指向的较大可弯曲部件包括第一对邻近的较大可弯曲部件和第二对邻近的较大可弯曲部件。
11.根据权利要求8到10任一项所述的装置,其中所述顶壁包括整体进入口和整体刺穿部件,所述整体刺穿部件与所述整体进入口流体连通,用于当将所述通用药瓶转接器伸缩地安装在所述药瓶上时穿刺药瓶塞子以能够与所述药瓶内部流体连通。
12.根据权利要求8到10任一项所述的装置,其中所述通用药瓶转接器能伸缩地安装在预附接的起始地未开启的药瓶上,所述顶壁包括覆盖在所述预附接的起始地未开启的药瓶的最上药瓶表面上的轴向指向的管状杆,
所述液体药物转移装置进一步包括分离式液体转移部件,所述分离式液体转移部件带有置于所述杆中的刺穿尖端,用于在朝向所述药瓶向下推动所述液体转移部件时穿刺所述药瓶塞子以能够与所述药瓶内部流体连通。
13.一种液体药物转移装置,其用于和含有输液液体并且具有注入口的输液袋一起使用,所述注入口终止在包括带有暴露的塞表面的自密封塞的注入口末端,所述注入口末端具有尾随注入口边缘,
所述液体药物转移装置包括具有纵向外壳轴并且包括通用注入口接头的开口的外壳,
所述通用注入口接头具有与所述纵向外壳轴同向的纵向接头轴和限定横向于所述纵向接头轴的水平面的闭合支撑环,
所述支撑环具有弹性地可弯曲地安装在其上的多个可弯曲接头部件和自由接头部件端,所述自由接头部件端从所述开口的外壳方向朝向位于所述支撑环之下的接头孔聚合使得所述通用注入口接头呈整体碗样形状,
布置为在用力滑动插入所述注入口末端通过所述接头孔进入所述开口的外壳时,所述注入口末端使所述多个接头部件从它们的未弯曲位置相对于所述接头轴向外地弯曲以在后面咬住所述尾随注入口末端边缘,由此防止所述注入口末端从所述开口的外壳中在与所述用力滑动插入相反的方向上的向外滑动拔出。
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JP2016028752A (ja) | 2016-03-03 |
US20170312175A1 (en) | 2017-11-02 |
IL221634A0 (en) | 2012-12-31 |
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IL237241B (en) | 2019-08-29 |
JP5837263B2 (ja) | 2015-12-24 |
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DK3167866T3 (en) | 2018-02-26 |
US9839580B2 (en) | 2017-12-12 |
IL268585A (en) | 2019-09-26 |
EP2887919B1 (en) | 2016-12-28 |
WO2014033706A3 (en) | 2014-06-19 |
IL268585B1 (en) | 2023-08-01 |
CN105769561A (zh) | 2016-07-20 |
CN104755059B (zh) | 2016-06-08 |
JP5996758B2 (ja) | 2016-09-21 |
IL268585B2 (en) | 2023-12-01 |
EP2887919A2 (en) | 2015-07-01 |
CN105769561B (zh) | 2018-08-14 |
EP3167866A1 (en) | 2017-05-17 |
JP2015526235A (ja) | 2015-09-10 |
EP3167866B1 (en) | 2017-11-22 |
US20150209230A1 (en) | 2015-07-30 |
WO2014033706A2 (en) | 2014-03-06 |
IL237241A0 (en) | 2015-04-30 |
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