CN101918074A - 药物混合及注射装置 - Google Patents

药物混合及注射装置 Download PDF

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CN101918074A
CN101918074A CN2008801082849A CN200880108284A CN101918074A CN 101918074 A CN101918074 A CN 101918074A CN 2008801082849 A CN2008801082849 A CN 2008801082849A CN 200880108284 A CN200880108284 A CN 200880108284A CN 101918074 A CN101918074 A CN 101918074A
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伊戈·德恩布鲁格
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Abstract

一种混合及注射装置，包括一针头和一针头座、一注射器连接部件和一混合腔连接组装件，所述混合腔连接组装件包括一包围所述针头的针头腔和一第一液体导管部分，从所述针头腔起密封，所述混合腔连接组装件还包括一混合腔连接部分，所述混合腔连接部分包括一与所述第一液体导管部分连通的第二液体导管部分，所述混合腔连接部分被设置成与一混合腔连通，所述注射器连接部件和所述针头座被设置成在当所述注射器连接部件和所述针头座位于所述第一相对连接方位时允许在所述注射器的内部和所述第一液体导管部分之间进行流体连接，以及在当所述注射器连接部件和所述针头座位于所述第二相对连接方位，沿着所述注射轴从所述第一相对方位轴向分离时，用于允许在所述注射器的内部和所述针头之间流体连接。

Description

药物混合及注射装置
对相关申请的参考引用
特此引用于2007年9月18日提交的申请号为60/973,180的发明名称为“液体控制装置”的美国临时专利申请，该临时申请的公开内容被引用并结合到本申请中，并且本申请特此根据CFR的37条的1.78a(4)和(5)(i)要求该临时申请的巴黎公约优先权。
发明领域
本发明一般地涉及液体药物注射装置。
发明背景
以下专利文件被认为是代表了本领域技术现状：US5,584,819；US5,746,733；US5,755,696；US5,820,621；US5,827,262；US5,832,971；US5,887,633；US5,919,182；US6,238,372；US6,280,430；US6,524,278；US6,729,370；US2007/0088313；US2007/0167904；US2007/0270778和U82008/0009789。
发明概述
本发明旨在提供一种改进的药物混合及注射装置。
因此，根据本发明的一优选实施例，所提供的药物混合及注射装置包括一注射针头组件、一注射器连接部件和一药物混合腔连接组件，所述注射针头组件包括一沿着一注射轴(injection axis)延伸的针头和一固定所述针头的针头座；所述注射器连接部件在位于沿所述注射轴相互轴向分离的至少第一和第二相对连接方位(engagement orientations)被设置在其第一轴向末端去容纳一无针头注射器以及在其第二轴向末端来连接所述针头座，所述药物混合腔连接组件包括一具有一手动连接部分(hand-engageable portion)的中间部分，所述中间部件包括一包围所述针头的针头腔和一第一液体导管部分，所述中间部件包括一围绕该针头的针头腔室，一从所述针头腔起密封的第一液体导管部分以及所述药物混合腔连接组件还包括一药物混合腔连接部分，所述药物混合腔连接部分包括一与所述第一液体导管部分连通的第二液体导管部分，且所述药物混合腔连接部分被设置成与一药物混合腔连通，所述注射器连接部件和所述针头座被设置成用于在当所述注射器连接部件和所述针头座位于所述第一相对连接方位时允许在所述无针头注射器的内部和所述第一液体导管部分之间进行流体连接，以及在当所述注射器连接部件和所述针头座位于所述第二相对连接方位，并被沿着所述注射轴从所述第一相对方位轴向分离时，允许在所述无针头注射器的内部和所述针头之间流体连接。
根据本发明的一优选实施例，药物混合及注射装置操作所述手动连接部分使得所述针头座和所述注射器连接部分从沿着所述注射轴的所述第一相对方位向沿着所述注射轴的所述第二相对方位作相对轴向移动。
根据本发明一优选实施例，所述中间部分和所述药物混合腔连接部分被制造成独立的部件或一个整体。
优选地，一种药物混合及注射方法包括提供一药物混合及注射组件，所述药物混合及注射组件包括一沿着一注射轴延伸的针头和一固定所述针头的针头座、一注射器连接部件和一药物混合腔连接组件，所述注射器附件并位于相互地沿着所述注射轴轴向分离的至少第一和第二相对连接方位(engagement orientations)被设置成在其第一轴向末端容纳一无针头注射器和在其第二轴向末端连接所述针头座，将一药物混合腔与所述药物混合腔连接组装件连接，将一注射器连接到所述注射器连接部件，当所述注射器连接部件和所述针头座位于所述第一相对连接方位时混合所述药物混合腔内的药物并抽吸混合的药物进入所述注射器，提供所述针头座和所述注射器连接部件沿着所述注射轴的相对轴向移动，以使得所述注射器连接部件和所述针头座位于所述第二相对连接方位，将所述药物混合腔连接组件从所述注射器连接部件脱离，并从所述注射器通过所述针头注射所述混合药物。
根据本发明的一优选实施例，所述药物混合腔连接组件包括一包围所述针头的针头腔和一液体导管部分，从所述针头腔起密封，且所述注射器连接部件和所述针头座被配置成用于在当所述注射器连接部件和所述针头座位于所述第一相对连接方位时允许在所述无针头注射器内部和所述第一液体导管部分之间进行流体连接，以及在当所述注射器连接部件和所述针头座位于所述第二相对连接方位，沿着所述注射轴从所述第一相对方位轴向分离时允许在所述无针头注射器内部和所述针头之间进行流体连接。
根据本发明的一优选实施例，所述药物混合腔连接组件包括一手动连接部分，所述手动连接部分可选择地使所述针头座和所述注射器连接部分从沿着所述注射轴的所述第一相对方位向沿着所述注射轴的所述第二相对方位作相对轴向移动。
附图简要说明
将从以下详细的描述说明来了解并更全面地理解本发明：
图1和2为根据本发明的一优选实施例构成的和使用中(operative)的药物混合及注射装置的简化透视组装图和简化透视分解图；
图3A、3B和3C为图1和2中所示装置的注射器连接部件的简化示意图；
图4A和4B为图3B和3C中沿IVA-IVA线和IVB-IVB线的剖面示意图；
图5A、5B和5C为图1和2中所示装置的针头座的简化示意图；
图6A和6B为图5B和5C中沿VIA-VIA线和VIB-VIB线的剖面示意图；
图7A、7B、7C、7D、7E和7F为图1和2中所示装置的一药物混合腔连接组装件的第一部分的简化示意图；
图8A和8B为图7C和7D中沿VIIIA-VIIIA线和VIIIB-VIIIB线的剖面示意图；
图9A、9B和9C为图1和2中所示装置的一药物混合腔连接组装件的第二部分的简化示意图；
图10A和10B为图9B和9C中沿XA-XA线和XB-XB线的剖面示意图；
图11A、11B、11C、11D、11E、11F、11G和11H为图1至10B中所示装置的操作状态的各个阶段的简化侧视图；
图12A为图11A-11E所示的注射器连接部件、针头座和药物混合腔连接组装件的相对方位的剖面示意图；
图12B为图11F所示的注射器连接部件、针头座和药物混合腔连接组装件的相对方位的剖面示意图；
图12C为图11G所示的注射器连接部件、针头座和药物混合腔连接组装件的相对方位的剖面示意图；
图12D为图11H所示注射器连接部件和所述针头的相对方位的剖面示意图、
发明详述
现在参照图1-11H，其显示了根据本发明的一优选实施例的构成的和操作的药物混合及注射装置的结构和操作图。
图1和2显示了根据本发明的一优选实施例的构成的和使用中的药物混合及注射装置的简化透视组装图和简化透视分解图。如图1和2所示，所述药物混合及注射装置优选地包括一注射器连接部件100和一注射针头组件(injection needle assembly)102，所述注射针头组件102包括一沿着一注射轴106延伸的针头104和一通常通过粘合剂固定所述针头的针头座108。
根据本发明的一优选实施例，所述注射器连接部件100被设置成：位于沿着所述注射轴106相互地轴向分离的至少第一和第二相对连接方位。在其第一轴向末端110容纳一无针头注射器(未图示)，并在其第二轴向末端112连接所述针头底座108。
所述药物混合及注射装置优选地还包括一药物混合腔连接组件120，所述药物混合腔连接组件120包括一具有一手动连接部分124的第一部分122，该中间部件优选地包括一包围所述针头104的针头腔128和一第一液体导管部分126，所述药物混合腔连接组件120从所述针头腔128起密封，所述药物混合腔连接组装件120还包括药物混合腔连接部分130，所述药物混合腔连接部分130包括一与所述第一液体导管部分126连通的第二液体导管部分132，所述药物混合腔连接部分130被设置成用于与一药物混合腔(未图示)连通，所述药物混合腔可以是例如一小瓶或安瓿并可选择地为任意其它适合的药物混合腔。
在所述用图说明的实施例中，部分122和130显示为独立的元件，可以理解的是，备选地，它们可被制作成一整体部件。
根据本发明的一优选实施例，所述注射器连接部件100和所述针头座108被设置成在当所述注射器连接部件100和所述针头座108位于所述第一相对连接方位时允许在所述无针头注射器(未图示)的内部和所述第一液体导管部分122之间进行流体连接，以及在当所述注射器连接部件100和所述针头座108位于所述第二相对连接方位，沿着所述注射轴从所述第一相对方位轴向分离时，允许在所述无针头注射器(未图示)的内部和所述针头104之间进行流体连接，。
优选地，当所述注射器连接部件100和所述针头座108位于所述第一相对连接方位时，所述无针头注射器(未图示)内部的液体被阻止流到所述针头104，以及当所述注射器连接部件100和所述针头座108位于所述第二相对连接方位，被沿着所述注射轴从所述第一相对方位轴向分离时，所述无针头注射器(未图示)的内部的液体被阻止流到所述第一液体导管部分122。
图3、3A、3B、4A和4B，显示了注射器连接部件100的一优选实施例。如图3-4B所示，所述注射器连接部件100是一通常的圆筒状部件，在末端110形成一螺旋栓(Luer lock)，以及在末端110具有一外螺纹150，和一在末端110开口的一般圆锥形的内部管道152(internal passageway)。
在所述注射器连接部件100的末端112具有第一和第二，通常轴向延伸的，连接片154和156。片154具有一面向内部末端部分158(inwardly facing end portion)，所述面向内部末端部分158具有一通常截短的圆锥形横截面并具有一保持肩形凸出部表面160(retainingshoulder surface)。片156具有一面向内部末端部分162，所述面向内部末端部分162具有一通常截短的圆锥形横截面并具有一保持肩形凸出部表面164。
管道152的末端具有一分隔壁170，所述分隔壁170具有一一般在中央的孔172和一侧孔174。一般中央孔172局部限定成一带有一通常截短的圆锥形外壁表面176的轴向部分。环绕壁表面176并延伸至末端112是由一一圆筒状壁180表面形成的凹槽178。
图5、5A、5B、6A和6B显示了针头座108的一优选实施例。如图5-6B所示，所述针头座108优选为一整体部件，通常采用注塑成型，其包括一中心圆筒状部分200，它设有一轴向针头固定孔202，以便沿着注射轴106容纳和固定针头104(未图示)，与一流体连通孔204相连通。
围绕中心圆筒状部分200的部件是一中间圆筒状部分206，在所述中间圆筒状部分206内具有一环形凹槽208，所述环形凹槽208在边缘连接一壁212的通常是圆锥形壁表面210，壁212的外表面构成了中间圆筒状部分206的外表面圆筒状壁表面214的一部分。圆筒状部分206被配置成一定尺寸和一定形状以便在所述注射器连接部件100和所述针头座108位于所述第二相对连接方位时轴向滑动连接凹槽178。在该方位上，轴向延伸到中间圆筒状部分206以外的中心圆筒状部分200的部分滑动地密封连接所述注射器连接部件的通常的孔172。
液体导管216从凹槽208起延伸，通常与所述注射轴106平行，并穿过所述中间圆筒状部分206的部分及穿过一座部分222，所述轴向针头固定孔202也延伸穿过所述座部分222。座部分222具有一通常平面肩形凸出部表面224(planar shoulder surface)和一相对的通常平面表面226以及圆锥形边缘表面228和230。
平行于注射轴106并从通常平面表面226起延伸典型地构成第一和第二并接的圆筒232和234。圆筒232优选以所述注射轴106为中心，且轴向针头固定孔202延伸穿过所述圆筒232。圆筒234具有一通常圆筒状凹槽236，所述通常圆筒状凹槽236与所述液体导管216相连通。
图7A、7B、7C、7D、7E、7F、8A和8B显示了第一部分122的一优选实施例。所述第一部分122优选为一通常圆筒状部件，优选地包括一第一通常是圆形的圆筒状部分240，它设置成可拆卸的连接所述注射器连接部件100，和一第二通常圆形的圆筒状部分242，所述通常圆形的圆筒状部分242具有一面向外部的圆锥形凸缘243(externally facing conicalflange)以便固定所述药物混合腔连接部分130。中间部分240和242是一手动连接部分244，所述手动连接部分244具有被通常平坦壁部分254和256分离的通常相对的表面弯曲的侧壁部分250和252。
手动连接部分244优选地包括一手动连接手柄260，所述手动连接手柄260可摆动连接通常平坦壁部分254，所述手动连接部分244还包括一可选择定位的保持边262。一般相对手动连接手柄260布置并延伸到通常平坦壁部分256的部分的上面的是一面向内部固定突起部264。
在手动连接部分244的内部，优选地设置有一壁270，与所述注射轴106平行并延伸，所述壁270末端连接一垂直所述注射轴106延伸的壁272。壁270和272优选地使第一液体导管部分126和针头腔128分开，所述针头腔128被壁270和272与其分隔开。
图9、9A、9B、10A和10B显示了所述第二部分130的一优选实施例。如图9-10B所示，第二部分130包括一与所述第一液体导管部分126连通的第二液体导管部分132，所述第二部分130被设置成用于与一药物混合腔(未图示)连接，所述药物混合腔可以是例如一小瓶或安瓿，并可选择地为任意其它适合的药物混合腔。
可以看出第二部分130包括一第一通常圆形的圆筒状部分280和一第二通常圆形的圆筒状部分282，所述第一通常圆形的圆筒状部分280优选地具有一对用于固定所述第一部分122的相对布置的窗口284和286，所述第二通常圆形的圆筒状部分282优选地具有一对相对布置的窗口288和290，和一用于连接一药物混合腔(未图示)的面向内部固定突起部292和294，所述第一通常圆形的圆筒状部分280和一第二通常圆形的圆筒状部分282被一中心具有一空心锥296的分隔壁295分开。使用时，锥296刺穿药物混合腔的弹性密封装置(未图示)，从而使在所述药物混合腔(未图示)与所述注射器内部(未图示)之间通过在锥296前端形成的孔298能够进行流体连通。
图11A、11B、11C、11D、11E、11F、11G和11H为简化侧视图说明，显示了图1-10B中所示装置的操作状态的各个阶段。图11A显示了将无针头注射器310与注射器连接部件100连接，并将小瓶320插入第二部分130。图11B显示无针头注射器310完全连接注射器连接部件100和小瓶320完全插入到第二部分130，可以理解的是在小瓶320完全插入到第二部分130后将小瓶320从第二部分130上去掉是非常困难或不可能的。
图11C显示了来自注射器310的液体被吸入小瓶320。这是由操作者进行操作，将带有已连接的注射器310和小瓶320的如图1所示的装置保持在如图所示的通常垂直的方向，推动所述注射器推杆312。
图11D显示小瓶320内的已混合的药物和带有已连接的注射器310和小瓶320的如图1所示的装置被转到相反的位置，如图所示。
图11E显示来自小瓶320的液体被吸入注射器310。这是由操作者进行操作，将带有已连接的注射器310和小瓶320的如图1所示的装置保持在如图所示的通常垂直的方向，拉动所述注射器推杆312。
图11F显示向内压迫手动连接手柄260。
图11G显示了通过推动包含小瓶320的所述药物混合腔连接组件120，使注射针头组件102和注射器连接部件100相对轴向移动。
图11H显示了从图1所示装置上移去包含小瓶320的所述药物混合腔连接组件120。
图12A、12B、12C和12D是图11A-11H所示的注射器连接部件100、针头座108和药物混合腔连接组件120的剖面示意图。
图12A是图11A-11E所示的所述注射器连接部件100、所述针头座108和药物混合腔连接组件120的第一相对连接方位的剖面示意图，所述注射器连接部件100、所述针头座108和药物混合腔连接组装件120被配设置成用以允许在所述无针头注射器(未图示)的内部和所述药物混合腔(未图示)之间进行流体连通，所述流体连通经过管道152、侧孔174和所述注射器连接部件100的凹槽178、凹槽208和所述针头座108的液体导管216、第一部分122的第一液体导管部分126和第二部分130的带有孔298的空心锥296。可以看出，手动连接手柄260阻止提供从第一相对连接方位向第二相对连接方位的相对轴向移动，并且面向内部固定突起部264顶着肩形凸出部表面224，防止药物混合腔连接组装件120从针头座108上移去。
图12B是图11F所示的所述注射器连接部件100、所述针头座108和药物混合腔连接组装件120的第一相对连接方位的剖面示意图，可以看出手动连接手柄260允许通过向内压迫手动连接手柄260而提供从第一相对连接方位向第二相对连接方位的相对轴向移动。
图12C是图11G所示的所述注射器连接部件100、所述针头座108和药物混合腔连接组装件120的第二相对连接方位的剖面示意图。所述注射器连接部件100、所述针头座108和药物混合腔连接组装件120被设置成用以允许所述无针头注射器内部(未图示)和针头104之间进行流体连接，所述流体连接通过所述注射器连接部件100的管道152、流体连通孔204和所述针头座108的轴向针头固定孔202。可以看出，中间圆筒状部分206插入到凹槽178用于防止所述无针头注射器内部(未图示)和所述药物混合腔(未图示)之间进行流体连接，并且突起部264允许通过从肩形凸出部表面224向外压迫突起部264将药物混合腔连接组装件120从针头座108上除去。
图12D为当图1所示装置处于准备用于注射的状态时，图11H所示的所述注射器连接部件100和针头座108的相对方位的剖面示意图。

Claims (7)

1.药物混合及注射装置，包括：
一注射针头组件，所述注射针头组件包括一沿着一注射轴延伸的针头和一固定所述针头的针头座；
一注射器连接部件，所述注射器连接部件设置成位于沿着所述注射轴相互地轴向分离的至少第一和第二相对连接方位在其第一轴向末端容纳一无针头注射器并在其第二轴向末端连接所述针头座；以及
一药物混合腔连接组件，所述药物混合腔连接组装件包括：
一具有一手动连接部分的中间部分，所述中间部件有一包围所述针头的针头腔和一第一液体导管部分，其从所述针头腔起密封；和
一药物混合腔连接部分，所述药物混合腔连接部分包括一与所述第一液体导管部分连通的第二液体导管部分，所述药物混合腔连接部分被设置成用于与一药物混合腔连通；
所述注射器连接部件和所述针头座被设置成用于在当所述注射器连接部件和所述针头座位于所述第一相对连接方位时允许在所述无针头注射器的内部和所述第一液体导管部分之间进行流体连接，以及在当所述注射器连接部件和所述针头座位于所述第二相对连接方位，沿着所述注射轴从所述第一相对方位轴向分离时，用于允许在所述无针头注射器的内部和所述针头之间流体连接。
2.根据权利要求1所述的药物混合及注射装置，其中操作所述手动连接部分使得所述针头座和所述注射器连接部分从沿着所述注射轴的所述第一相对方位向沿着所述注射轴的所述第二相对方位作相对轴向移动。
3.根据权利要求1或2任一项所述的药物混合及注射装置，其中所述中间部分和所述药物混合腔连接部分被制造成独立的部件。
4.根据权利要求1或2任一项所述的药物混合及注射装置，其中所述药物混合腔连接组装件被制造成一整体部件。
5.一种药物混合及注射方法，包括：
提供一药物混合及注射组件，所述药物混合及注射组件包括一沿着一注射轴延伸的针头和一固定所述针头的针头座、一注射器连接部件和一药物混合腔连接组件，所述注射器连接部件被设置成位于相互地沿着所述注射轴轴向分离的至少第一和第二相对连接方位在其第一轴向末端容纳一无针头注射器和在其第二轴向末端连接所述针头座；
将一药物混合腔与所述药物混合腔连接组件连接；
将一注射器连接到所述注射器连接部件；
当所述注射器连接部件和所述针头座位于所述第一相对连接方位时混合所述药物混合腔内的药物并抽吸混合的药物进入所述注射器；
提供所述针头座和所述注射器连接部件沿着所述注射轴的相对轴向移动，以使得所述注射器连接部件和所述针头座位于所述第二相对连接方位；
将所述药物混合腔连接组件从所述注射器连接部件脱离；以及
从所述注射器通过所述针头注射所述混合药物。
6.根据权利要求5所述的一种药物混合及注射方法，其中，所述药物混合腔连接组装件包括一包围所述针头的针头腔和一液体导管部分，从所述针头腔起密封，且所述注射器连接部件和所述针头座被设置成在当所述注射器连接部件和所述针头座位于所述第一相对连接方位时允许在所述无针头注射器内部和所述第一液体导管部分之间进行流体连接，以及在当所述注射器连接部件和所述针头座位于所述第二相对连接方位，沿着所述注射轴从所述第一相对方位轴向分离时，允许在所述无针头注射器内部和所述针头之间进行流体连接。
7.根据权利要求5或6任一项所述的一种药物混合及注射方法，其中，所述药物混合腔连接组件包括一手动连接部分，所述手动连接部分可选择地使所述针头座和所述注射器连接部分从所述沿着所述注射轴的第一相对方位向沿着所述注射轴的所述第二相对方位作相对轴向移动。
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CN104884028B (zh) * 2012-12-17 2018-04-27 尤尼特拉克特注射器公司 瓶适配器
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US20100204679A1 (en) 2010-08-12
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