CN106880494A - Packaging assembly preventing premature activation - Google Patents

Packaging assembly preventing premature activation Download PDF

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Publication number
CN106880494A
CN106880494A CN201710063621.8A CN201710063621A CN106880494A CN 106880494 A CN106880494 A CN 106880494A CN 201710063621 A CN201710063621 A CN 201710063621A CN 106880494 A CN106880494 A CN 106880494A
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CN
China
Prior art keywords
container
assembly
housing
body
recombinant
Prior art date
Application number
CN201710063621.8A
Other languages
Chinese (zh)
Inventor
斯科特·R·阿里亚格诺
马克·D·席林
托马斯·V·普拉
Original Assignee
百深有限责任公司
百深公司
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Application filed by 百深有限责任公司, 百深公司 filed Critical 百深有限责任公司
Priority to PCT/US2012/026127 priority Critical patent/WO2013126055A1/en
Priority to CN201710063621.8A priority patent/CN106880494A/en
Priority to CN201280070539.3A priority patent/CN104136344B/en
Publication of CN106880494A publication Critical patent/CN106880494A/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/14Details, e.g. provisions for hanging or shape retaining means; Accessories therefor, e.g. inlet or outlet ports, filters or caps
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006Piercing means
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D75/00Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
    • B65D75/28Articles or materials wholly enclosed in composite wrappers, i.e. wrappers formed by associating or interconnecting two or more sheets or blanks
    • B65D75/30Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding
    • B65D75/32Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents
    • B65D75/325Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet being recessed, and the other being a flat not- rigid sheet, e.g. puncturable or peelable foil
    • B65D75/326Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet being recessed, and the other being a flat not- rigid sheet, e.g. puncturable or peelable foil and forming one compartment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/14Details, e.g. provisions for hanging or shape retaining means; Accessories therefor, e.g. inlet or outlet ports, filters or caps
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006Piercing means
    • A61J1/201Piercing means having one piercing end
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/14Details, e.g. provisions for hanging or shape retaining means; Accessories therefor, e.g. inlet or outlet ports, filters or caps
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006Piercing means
    • A61J1/2013Piercing means having two piercing ends
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/14Details, e.g. provisions for hanging or shape retaining means; Accessories therefor, e.g. inlet or outlet ports, filters or caps
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2089Containers or vials which are to be joined to each other in order to mix their contents

Abstract

The invention relates to a packaging assembly (10) preventing premature activation. The packaging assembly (10) is used for a medicine recombination component (100) and comprises a main body (14), the medicine recombination component (100) and a removable cover (12). The main body comprises multiple protrusions (16 and 18), and the multiple protrusions are configured to be matched with multiple corresponding parts of the medicine recombination component so as to inhibit axial translation and rotating translation of the medicine recombination component and constituent parts thereof during conveyance and treatment. By preventing axial movement and rotating movement during conveyance, premature and accidental impaling or pollution of medicine or puncture in the medicine recombination component is minimized.

Description

防止过早激活的包装组件 Prevent premature activation of the package assembly

[0001] 本申请是申请号为201280070539.3、申请日为2012年2月22日、标题为“防止过早激活的包装组件”的中国申请的分案申请。 [0001] This application is Application No. 201280070539.3, filed on February 22, 2012, entitled divisional applications "to prevent premature activation of the package assembly," the Chinese application.

技术领域 FIELD

[0002] 本公开大体涉及一种医疗包装装置组件,并且更具体地涉及包装与医疗装置的组合。 [0002] The present disclosure relates generally to packaging a medical device assembly, and more particularly relates to a combination of medical device packaging.

背景技术 Background technique

[0003] 以冻干形式供应特定药物。 [0003] The supply of a particular drug in a lyophilized form. 冻干药物必须与水混合,以将药物重新组成适合注射到患者体内的形式。 Lyophilized drug must be mixed with water to reconstitute the drug in the form suitable for injection into a patient. 特别地,形成可注射溶液的组分必须无菌,以避免感染。 In particular, the components form injectable solutions must be sterile to avoid infection. 重组过程给需要自己或由他人注射(例如在住宅环境中)的患者或护理者提出困难。 Restructuring themselves or by others who need an injection (for example in a residential environment) patient or caregiver presented difficulties. 患者或护理者必须遵循药物容器、稀释容器和转移注射器的顺序操作,患者或护理者使用针头刺穿与相应容器关联的瓶塞。 Sequence of the patient or caregiver must follow medicament container, dilution vessel and the transfer operation of the injector, the patient or caregiver using a needle piercing the stopper associated with the respective container. 患者或护理者需要遵循已确立的无菌操作,以避免污染。 Patients or caregivers should follow aseptic established to avoid contamination.

[0004] 如美国专利申请No. 13/217,967 (“ '967'申请”)中所述,其公开内容在此通过引用以其整体并入,在从制造商、销售商或装配商运送至终端用户时,装置的药物容器、稀释容器和转移注射器被安装在同一壳体内。 The [0004] The U.S. Patent Application No. 13 / 217,967 ( " '967' application"), the disclosure of which is incorporated herein by reference in its entirety, to the terminal in the transport from the manufacturer, the seller or supplier assembly when a user, the drug container unit, dilution vessel and transferring syringe are mounted in the same housing. 由于转移注射器相对于药物容器中的每个药物容器的特定布置,所以要特别小心,以防止在装运和操作期间,由转移注射器导致的容器瓶塞的意外过早刺穿或激活。 Since transferring syringe medicament container relative to a particular arrangement of each of the drug container, be careful so as to prevent during shipment and operation of a vessel closure unexpected result in premature transfer of the syringe to pierce or activation. 因此,重组装置的运送在防止产品的过早激活方面提出挑战,从而确保无菌性并且使得终端用户能够易于使用产品。 Thus, the transport apparatus recombinant challenge in preventing premature activation of the product, so as to allow end users to ensure sterility and easy to use product. 冻干药物通常非常昂贵,使得运送期间受到的意外激活或污染最小甚至更重要。 Lyophilized drugs are typically very expensive, so that accidental activation during transport or suffered minimal pollution even more important.

发明内容 SUMMARY

[0005] 本公开提供一种包括包装和重组组件以及相关的医疗产品的包装组件,该包装组件防止重组组件的过早激活。 [0005] The present disclosure provides a recombinant comprising packaging and medical products and related components of the package assembly, the package assembly to prevent premature activation of the recombinant component. 该包装成型为像是将重组组件放在摇篮里。 The package is shaped like the reorganization of assembly on the cradle. 该包装集成有重组组件的相关部件,且在装运和操作期间,维持重组组件的各个部分在包装中彼此隔离。 The integrated packaging-related recombinant member assembly, and during shipment and operation, to maintain the various portions of the recombinant components isolated from each other in a package.

[0006] 在一个实施例中,重组组件包括外壳,该外壳具有上套管和下套管。 [0006] In one embodiment, the recombinant assembly includes a housing, the housing having an upper casing and a lower casing. 外壳限定大体管状通道,且在上套管中包括多个径向间隔的孔以及在下套管中包括多个径向间隔的窗口。 The housing defines a generally tubular passage, and includes a hole in the sleeve and a lower sleeve comprises a plurality of radially spaced plurality of radially spaced windows. 转移套装组件布置在外壳内,处在上套管与下套管之间。 Transfer set assembly disposed within the housing, located between the upper casing and the lower casing. 转移套装组件包括一对相对的穿刺,所述一对相对的穿刺包括下穿刺和上穿刺。 Transfer set assembly includes a pair of opposing puncturing, the puncturing comprises a pair of opposed upper puncture and puncture. 上和下穿刺形成一部分流动路径。 The upper and lower part of the flow path formed puncture.

[0007] 第一容器被布置为至少部分地在外壳的上套管内,处于通道中且靠近上穿刺。 [0007] The first container is disposed at least partially within the sleeve housing, and in the channel near the puncture. 第一容器包括第一小瓶和第一瓶塞,第一瓶塞给被保持在第一小瓶内的医疗内容物提供无菌屏障。 A first vial comprising a first container and a first stopper, a first stopper to be held in the first medical vial contents provide a sterile barrier. 在一个实施例中,第一容器被布置成使得,第一瓶塞面向下或面朝外壳的中心。 In one embodiment, the first container is arranged such that a first stopper face facing the housing or the center. 第二容器被布置在下套管内,处于通道中且靠近下穿刺。 The second container is disposed in the lower casing, in the passage and near the puncture. 第二容器包括第二小瓶和第二瓶塞,第二瓶塞给第二小瓶的内容物提供无菌屏障。 A second vial comprising a second container and a second stopper, the second stopper to the contents of the second vial to provide a sterile barrier. 在一个实施例中,第二容器被布置成使得,第二瓶塞向上面朝第一瓶塞。 In one embodiment, the second container is arranged such that a first upwardly facing second cork stopper. 由穿刺形成的流动路径允许容器在被穿刺时彼此流体连通。 A flow path formed by the piercing allows fluid communication with each other when the container is punctured.

[0008] 在实施例中,一旦对第一容器施加第一力,则转移套装组件的上穿刺就刺穿第一瓶塞。 [0008] In an embodiment, upon application of a first force to a first container, the transfer set assembly of the first puncture pierce stopper. 该力能够来自在第一容器上的向下挤压的患者或护理者,从而将第一容器推入外壳中并推到上穿刺上。 The force from the patient or caregiver can be pressed downward in the first container, the first container so as to push the housing and pushed onto the puncture. 在上穿刺刺穿第一容器的第一瓶塞之后,允许第二容器相对于转移套装组件轴向移动。 After the first piercing the stopper of the first container to the puncture, to allow the second container relative axial movement of the transfer set assembly. 然后,一旦施加第二力,并且通过第一容器且具体是通过第一容器的第一小瓶与触发机构接合,转移套装组件的下穿刺就刺穿第二瓶塞。 Then, once the second force, and in particular by the trigger mechanism is engaged with the first container and the first container by applying a first vial, the transfer set assembly piercing a second pierce stopper. 当第二瓶塞被刺穿时,就进入第二容器的真空。 When the second stopper is pierced into the vacuum on the second container. 第一和第二力可为预定的力,或者可处于期望水平。 The first and second predetermined force may be a force, or may be at a desired level.

[0009] 在实施例中,第一容器封围液体,并且第二容器封围冻干产品。 [0009] In an embodiment, the first container encloses a liquid and a second vessel enclosing the lyophilized product. 利用上穿刺刺穿第一容器的第一瓶塞,并且利用下穿刺刺穿第二容器的第二瓶塞,使第一和第二容器通过转移套装组件的流动路径而彼此流体连通。 By using a first puncturing pierceable stopper of the first container, and with a second Spikes piercing of the second container in the first container and a second flow path in fluid communication with each other through the transfer set assembly. 然后,第二容器的真空导致第一容器的液体通过流体通路吸入第二容器中。 Then, the vacuum vessel of the second liquid causes the first container into the second container through the fluid pathway. 液体与冻干药物混合,以配制用于患者使用的药物。 Lyophilized drug mixed with a liquid, to formulate a medicament for the patient.

[0010] 包装组件被构造成使得,重组组件配合在包装中,并且该包装在物理上抑制第一容器或第二容器在外壳内的轴向平移。 [0010] The package assembly is configured such that, in a package with a recombinant component, and the packaging container to suppress the first or second container in an axial translation within the housing physically. 通过抑制第一或第二容器在外壳内的任何明显的轴向平移,防止第一容器的第一瓶塞被上穿刺或者第二容器的第二瓶塞被下穿刺意外或过早的刺穿。 The first or second container by suppressing any significant axial translation within the housing, prevent the second stopper is a first stopper on the first container or the second container is punctured under accidental or premature puncture piercing .

[0011] 在实施例中,该包装包括内部腔室,该内部腔室形成有多个凹进和突起,该多个凹进和突起成型为与重组组件的匹配部件互补。 [0011] In an embodiment, the package comprises an inner chamber, the inner chamber is formed with a plurality of recesses and projections, the plurality of recesses and protrusions shaped to match with the recombinant member complementary assembly. 该包装的内部腔室形成为使得,重组组件以预定构造适当地接合该包装的互补的凹进和突起。 The package is formed such that the inner chamber, recombinant assembly in a predetermined configuration suitably engage complementary recesses and projections of the package. 例如,在包装的端部处存在第一和第二凹进,第一和第二凹进紧抱(cradle)从重组组件的外壳延伸的第一和第二容器的第一和第二小瓶。 For example, there is a first and a second recessed portion at the end of the package, a first and a second recess hug (Cradle) a first and a second vial of the first and second vessel extending from the housing assembly of the recombinant. 延伸到该包装的内部腔室内的多个突起匹配并且延伸穿过下列多个孔,即重组组件的外壳的上套管中的多个孔和下套管中的多个孔。 A plurality of extending into the interior cavity of the package and extends through these projections matching the plurality of apertures, a plurality of holes on the sleeve housing a plurality of apertures i.e. recombinant assembly and a lower casing.

[0012] 外壳中的孔允许包装主体的突起延伸到由外壳形成的通道中,并且该孔绕小瓶的颈部的一部分接合小瓶,该小瓶能够为具有颈部开口的小玻璃瓶。 Hole in the housing [0012] to allow the package body protrusion extends into the channel formed by the housing, and a portion of the aperture around the neck of the vial engages the vial, the vial was able to have a neck opening of the vial. 突起挂住外壳的孔,以便防止第一和第二相应容器在包装内旋转。 Projection caught bore of the housing so as to prevent rotation of the first and second respective container within the package. 突起与小瓶颈部的接合也防止容器相对于彼此、 相对于转移套装组件或相对于外壳的无意的轴向平移。 Projection engagement also prevents the vial container neck relative to one another, unintentional transfer set assembly axially with respect to the housing or with respect to translation. 通过保持第一和第二容器相对于彼此且相对于转移套装组件大致轴向静止,包装主体的内部腔室的突起维持上穿刺和下穿刺分别处于距第一容器和第二容器中的每个容器的一个分离距离处。 By holding the first and second container relative to the piercing protrusion and relative to maintain a substantially axially stationary, interior chamber of the package body and the transfer set assembly respectively in the puncture from the first and second containers each another a distance separating the container. 由于最小化或防止了在装运和操作期间重组组件的部件的轴向平移,所以也最小化转移套装组件的相应穿刺导致的第一和第二容器的过早刺穿的情况。 Due to minimize or prevent the axial translation member and recombinant shipping assembly during operation, the situation is also minimized premature piercing of the respective first and second container transfer set assembly piercing caused.

[0013] 在此描述其它的特征和优点,并且将通过下文详细说明和附图明白这些其它的特征和优点。 [0013] The other features and advantages described, and the detailed description and drawings of these further apparent from the following features and advantages.

附图说明 BRIEF DESCRIPTION

[0014] 图1是本公开的组装的包装的一个实施例的透视图。 [0014] FIG. 1 is a perspective view of one embodiment of the present disclosure package assembly.

[0015] 图2是本公开的包装、被容纳在该包装内的重组组件和用于该包装的盖子的一个实施例的分解图。 [0015] FIG. 2 is a package of the present disclosure, an exploded view of an embodiment of a recombinant assembly is housed within the package and the lid for the package.

[0016] 图3是本公开的组装的包装和药物重组组件的一个实施例的主体侧的视图。 [0016] FIG. 3 is a side view of one embodiment of the subject and drug packaging assembly of the present disclosure recombinant assembled.

[0017] 图4是图3的沿图3的线IV-IV截取的组装的包装的截面图。 [0017] FIG. 3 is a sectional view taken in line IV-IV of FIG. 3 along FIGS assembled packaging.

[0018] 图5是本公开的包装的一个实施例的底视图。 [0018] FIG. 5 is a bottom view of one embodiment of the present disclosure package.

[0019] 图6是图5的沿图5的线VI-VI截取的包装的截面图。 [0019] 5 FIG. 6 is a sectional view taken in line VI-VI of FIG. 5 along the package of FIG.

[0020] 图7是本公开的组装的包装的一个实施例的侧视图。 [0020] FIG. 7 is a side view of one embodiment of the present disclosure package assembly.

[0021] 图8是本公开的组装的包装的一个实施例的端视图。 [0021] FIG. 8 is an end view of one embodiment of the present disclosure package assembly.

具体实施方式 Detailed ways

[0022] 本公开提供了一种包括组装的包装和重组组件的包装组件。 [0022] The present disclosure provides a package assembly comprising a package and assembled recombinant components. 包装组件特别用于防止在装运和操作期间的重组组件的过早激活。 Special packaging assembly to prevent premature activation of the recombinant assembly during shipment and operation. 虽然包装组件在本文中被主要描述为包括重组组件,但是应明白,在运送具有在使用前分离的组分的其它药物组件或其它产品期间,可以使用适当构造的包装。 Although the package assembly is primarily described herein as comprising a recombinant component, it should be appreciated that other drugs during the transport assembly having separate components prior to use or other product, the packaging may be used appropriately configured.

[0023] 现在参考附图且特别是图1和2,其中大致指示组装的包装10。 [0023] Referring now to the drawings and in particular FIGS. 1 and 2, wherein a rough indication of the package 10 is assembled. 组装的包装10大致包括可移除盖子12、主体14和药物重组组件100 (图2)。 Assembled package 10 generally includes a removable cover 12, body 14 and recombinant drugs assembly 100 (FIG. 2).

[0024] 可移除盖子12能够由任何一种或更多高密度聚乙烯纤维诸如TYVEK1(、箱材料或纸材料制成,并且在一个实施例中,可移除盖子12通过热激活粘合剂而被粘附至主体14。 粘合剂和施加过程使得可移除盖子12保持稳固地粘附至主体14,但是也可由患者较容易地移除。 [0024] 12 can be removably (made of any one or more cover high-density polyethylene fiber material, such as a box or a paper TYVEK1 material, and in one embodiment, the cover 12 may be removed by thermally activated adhesive agent is adhered to the main body 14 so that the adhesive application process and a removable cover 12 remains firmly adhered to the body 14, but may also be more easily removed patient.

[0025] 主体14能够由可热变形的聚对苯二甲酸乙二酯(“PET”)材料构造。 [0025] body 14 can be constructed from a heat deformable polyethylene terephthalate ( "PET") material. 主体14能够通过热成型工艺形成的突起16、18、井状部(well) 20a至20c等而形成主体14的期望形状。 Body 14 can be formed by a thermoforming process the projections 16, 18, the well (well) 20a to 20c and the like formed body 14 of a desired shape. 在替代实施例中,主体14由聚合物材料制成,且通过注塑工艺成型。 In an alternative embodiment, the body 14 is made of a polymer material, and by an injection molding process.

[0026] 如图1和2中所示,盖子12密封地并可移除地附接至主体14,从而将重组组件100封围于包装10内。 [0026] As shown in FIG. 1 and 2, the lid 12 is sealingly and removably attached to the body 14, so that the recombinant assembly 100 is enclosed within the package 10. 可移除盖子12能够提供扁平表面,在该扁平表面上能够显示制造商指令和识别信息。 The removable lid 12 to provide a flat surface, able to display manufacturers instructions and identification information on the flat surface. 信息识别器可包括条形码、图形代码、公司信息和互联网地址,以将用户引导至更详细信息。 May include information identifying a bar code, graphics code, company information, and Internet address to direct users to more detailed information. 该信息可包括医疗信息、患者识别和处方信息、制造商信息、许可和政府机构信息、生产和过期日期信息以及使用指导。 This information may include medical information, patient identification and prescription information, manufacturer information, licensing and government agencies of information, production and expiration date information and the use of guidance.

[0027] 如图1和2中所示,主体14形成为限定内部腔室,内部腔室包括突出到腔室内的多个突起16和18、以及从腔室的内部延伸出去的井状部20a至20c。 [0027] As shown, the body 14 and forming an internal chamber 2 so as to define, inside the chamber into the chamber comprises a plurality of protruding projections 16 and 18, and the shaft portion 20a extending from the inside out of the chamber to 20c. 下文更详细地描述这些特征。 These features are described in more detail below. 本文使用的突起大致朝着主体14的内部腔室的中心延伸,而井状部大致从腔室的内部中心延伸出去。 Projecting substantially toward the center of the internal chamber of the body 14 extends used herein, the well portion and extending substantially away from the center of the interior chamber.

[0028] 内部腔室接纳图2中例示的药物重组组件100。 [0028] FIG internal chamber to receive medicament recombinant assembly 100 is shown in two cases. 药物重组组件100包括外壳110,该外壳110具有上部部分112 (当保持为使用时)和下部部分114 (当保持为使用时)。 Drug recombinant assembly 100 includes a housing 110, the housing 110 has an upper portion 112 (when the holder is used) and a lower portion 114 (when the holder is used). 上部部分112和下部部分114形成大致圆柱形通道。 An upper portion 112 and lower portion 114 forming a generally cylindrical passage. 药物重组组件100也包括:上容器120 (当保持为使用时),上容器120被至少部分地容纳在由外壳的上部部分112形成的通道内;下容器130 (当保持为使用时),下容器130被至少部分地容纳在由外壳的下部部分114形成的通道内;和接触端口塞140,该接触端口塞140被设置在外壳110的外部上。 Drug recombinant assembly 100 also includes: a container 120 (when the retainer is used), the container 120 is at least partially accommodated within the channel formed by the upper portion of the housing 112; lower container 130 (when the holder is used), the container 130 is at least partially accommodated within the passage by the lower portion of the housing 114 is formed; port and a contact plug 140, the plug 140 is disposed in contact with the port on the exterior of housing 110. 包装10的可移除盖子12密封地附接至主体14,从而将药物重组组件100封围在主体14内。 Package 10 can be removable lid 12 is sealingly attached to the body 14, so that the drug recombinant assembly 100 enclosed within the body 14.

[0029] 现在参考图3,示出从外观察的组装的包装10的主体侧的视图。 [0029] Referring now to Figure 3, there is shown assembled view viewed from an outer side of the main body 10 of the package. 第一对突起16和第二对突起18从主体14的围绕表面延伸到内部腔室中,从而接触药物重组组件100的匹配部件。 A first projection 16 and a second pair of projections 18 extending into the body 14 around the inner surface of the chamber so as to contact the drug recombinant matching member 100 from the assembly. 井状部20a、20b和20c相对于主体14的围绕表面从内部腔室向外延伸。 The well portions 20a, 20b and 20c with respect to body 14 extending outwardly from the surface around the inner chamber. 井状部20a、20b和20c至少基本扁平,且彼此共面(也参见图1和2),以便通过将井状部20a、20b和20c设置在稳定表面上,能够使包装10坐放在主体侧上。 The well portions 20a, 20b and 20c at least substantially flat and coplanar with one another (see also FIGS. 1 and 2), so that by the well 20a, 20b and 20c disposed on a stable surface, the package 10 can be seated in the body the upper side. 如图1至3中所示,主体14也在主体14的上端和下端处形成井状部22和24。 As shown in Figures 1 to 3, 14 are upper and lower ends of the body 14 formed in body portions 22 and 24 wells.

[0030] 现在参考图4,例示了沿图3的线IV-IV截取的横截面侧视图。 [0030] Referring now to Figure 4, it illustrates a cross-sectional side view taken along the line IV-IV 3. 由于与突起18的径向间隔和几何外形相比较的突起16的径向间隔和几何外形,在图3中已经夸大了线IV-IV,从而在图4的单个视图中更好地示出突起16和18两者的横截面。 Since the projections 18 and the radial spacing and geometry compared with the projection and radially spaced geometry 16 has been exaggerated in FIG. 3 the line IV-IV, in order to better illustrate a single projection view of FIG. 4 16 and 18 the cross section of both. 重组组件100及其外壳110的横截面图例示了重组组件的内容物。 Recombinant cross section of assembly 100 and the housing 110 figure illustrates contents of a recombinant component. 具体地,重组组件100包括第一或上容器120、第二或下容器130和转移套装组件200。 In particular, recombinant or upper assembly 100 includes a first container 120, container 130 and a second or lower transfer set assembly 200.

[0031] 如在此通过引用并入于此的'967申请中详细讨论的,转移套装组件200包括上穿刺202、下穿刺204和穿过上穿刺202和下穿刺204行进的流动路径。 [0031] As herein incorporated by reference '967 application are discussed in detail, the transfer set assembly 200 includes an upper 202 puncture, the puncture and puncture 204 through 202 and 204 puncture the lower flow path of travel. 上穿刺202面对上容器120的开口128,而下穿刺204面对下容器130的开口138。 Puncturing 202 facing the opening 128 of the container 120, 204 and the lower face of the lower container the piercing opening 138 130. 在各种实施例中,转移套装组件200 的塑料部分由适当的可模制和可消毒的塑料制成,诸如丙烯腈-丁二烯-苯乙烯共聚物(“ABS”)、聚碳酸酯(“PC”)或丙烯酸。 In various embodiments, the plastic part of the transfer set assembly 200 may be made of a suitable molded plastic and can be sterilized, such as acrylonitrile - butadiene - styrene copolymer ( "ABS"), polycarbonate ( "PC") or acrylic.

[0032] 上穿刺202能够包括上防护罩(upper boot) 206,该上防护罩206被构造用以覆盖和维持上穿刺的下部部分及上穿刺的流动路径部分的无菌性。 [0032] 202 can puncture the shield includes an upper (upper boot) 206, the protective cover 206 is configured to cover a lower and an upper portion and a puncturing maintain sterility of the flow path of the puncture portion. 类似地,下穿刺204包括下防护罩208,该下防护罩208被构造用以覆盖和维持下穿刺中的上部部分和流动路径部分的无菌性。 Similarly, the puncture 204 includes a lower shield 208, the lower shield 208 is configured for sterility and the upper portion of the flow path portion of the lower cover and puncture maintained. 在一个实施例中,上和下防护罩206、208由弹性体材料制成,一旦激活药物重组组件100,则上206和下208防护罩较易于分别被上穿刺202和下穿刺204刺穿。 In one embodiment, the upper and lower shields 206 and 208 made of an elastomeric material, once the drug recombinant activation assembly 100, the upper 206 and lower shield 208 are easier to puncture the puncture 202 and 204 pierced.

[0033] 转移套装组件200也能够包括注射器端口通路(如图2中所示,在塞子140之下),注射器端口通路大致垂直于穿过上穿刺202和下穿刺204行进的流动路径并维持与穿过上穿刺202和下穿刺204行进的流动路径的装有阀的流体连通。 [0033] The transfer set assembly 200 can includes a syringe via a port (shown in Figure 2, below the plug 140), the syringe port is substantially perpendicular to the piercing through the passage 202 and 204 puncture the lower traveling path and maintain a flow puncturing the puncture 202 through the flow path 204 of travel and the valved fluid communication. 注射器端口通路能够替代地不垂直地从转移套装组件200的流动路径延伸。 Alternatively, the syringe port opening can be non-perpendicular to the flow path extending from the transfer set assembly 200. 注射器端口通路与穿过重组组件100的外壳110 延伸的注射器端口连通。 Syringe injector port passage in communication with the housing 100 of the assembly 110 extending through recombinant port. 在图2中,注射器端口塞140接合注射器端口,以维持端口和连接中的流体路径的无菌性。 In FIG. 2, the syringe engages the syringe port port plug 140, to maintain the sterility of the fluid path ports and connections.

[0034] 在完全激活药物重组组件100后,用户移除注射器端口塞140,以露出注射器端口, 以便用户能够通过分离的注射器接触。 [0034] After the assembly 100 is fully activated recombinant drugs, the user removes the syringe port plug 140, to expose the syringe port, so that the user can come into contact through separate syringe. 注射器端口塞140由弹性体材料或橡胶材料制成,以便注射器端口塞140能够弯曲,以抓握和移除。 Syringe port plug 140 made of an elastomeric or rubber material, so that the syringe port plug 140 can be bent to grasp and remove. 注射器端口通路和穿刺流动路径允许从注射器端口至上和下容器120、130的流体连通。 Injector port passage communication with the puncture from the flow path to allow fluid injector ports 120, 130 of the upper and lower container.

[0035] 上部和下部容器120、130包括上部和下部小瓶121、131,例如,上和下小瓶121、131 由适当的医疗级的可杀菌玻璃或塑料制成。 [0035] The upper and lower portions 120, 130 includes upper and lower container vials 121, 131, e.g., the upper and lower 121 and 131 vials made of a suitable medical grade sterilizable glass or plastic. 上小瓶121和下小瓶131都大致为圆柱形,且具有类似几何外形,包括颈部部分122a、132a、主体部分122c、132c和边缘部分126、136。 121 vials and the vials 131 are substantially cylindrical and having a similar geometry, comprising a neck portion 122a, 132a, a body portion 122c, 132c and the edge portions 126, 136. 颈部部分122a、132a具有的直径小于主体部分122c、132c或边缘部分126、136。 Neck portion 122a, 132a having a diameter smaller than the body portion 122c, 132c or edge portions 126, 136. 上瓶塞124密封地塞住上小瓶121的上开口128,从而防止上容器120的内容物的污染或渗漏。 The stopper 124 seal the stoppered vials 121 of opening 128, so as to prevent contamination or leakage of the contents of the container 120. 类似地,下瓶塞134密封地塞住下小瓶131的下开口138,从而防止下容器130的污染或渗漏。 Similarly, the stopper 134 sealing the vials were stoppered under 131 of opening 138, so as to prevent contamination or leakage of the container 130. 上瓶塞124和下瓶塞134能够由橡胶或弹性体材料制成。 The stopper 124 and the stopper 134 can be made of rubber or elastomeric material. 应明白,本文中将上小瓶121和上瓶塞124的组件定义为上容器120。 It should be understood herein as a stopper on the vial 121 and the assembly 124 is defined on the container 120. 类似地,本文中将下小瓶131和下瓶塞134的组件定义为下容器130。 Similarly, the vial 131 to herein define the stopper assembly 134 and container 130 for the next.

[0036] 重组组件100的外壳110包括上壳体部分112和下壳体部分114,上壳体部分112和下壳体部分114也能够由丙烯腈-丁二烯-苯乙烯共聚物(“ABS”)、聚碳酸酯(“PC”)或丙烯酸制成。 Housing 110 [0036] Recombinant assembly 100 includes an upper housing portion 112 and a lower housing portion 114, upper housing portion 112 and the lower housing portion 114 can be made of acrylonitrile - butadiene - styrene copolymer ( "ABS "), polycarbonate (" the PC "), or made of acrylic. 上壳体部分112包括或限定多个孔116,而下壳体部分114包括或限定多个孔118 (如图2中最佳示出的)。 Upper housing portion 112 includes or defines a plurality of holes 116, and lower housing portion 114 includes or defines a plurality of apertures 118 (best shown in FIG. 2) is. 孔或窗口116和118都绕相应的外壳径向间隔隔开。 Apertures or windows 116 and 118 are radially spaced about the respective housing intervals. 孔116、118允许灭菌气体流动至内部部分和重组组件100的构件。 Apertures 116, 118 allow sterilization gas to flow to the inner member 100 of the assembly portion and recombination. 除了易于灭菌处理之外,当被容纳在重组外壳110中时,孔116、118向上部120和下部130容器提供至少部分接触。 In addition to easy sterilization outside, when the housing 110 is accommodated in a recombinant, the holes 116, 118, 120 upwardly to provide a contact portion and a lower portion 130 of the container at least partially.

[0037] 如' 967申请中更详细讨论的,一旦激活药物重组组件110,上穿刺202就刺穿上防护罩206和上部瓶塞124,以接触上容器120的内容物,之后,下穿刺204刺穿下防护罩208和下瓶塞134,以接触下容器130的内容物。 [0037] The 'once the drug recombinant activation assembly 110, the puncture 967 application discussed in more detail on the shield 202 to pierce the stopper 206 and the upper portion 124 to the contact of the contents of the container 120, after the puncture 204 piercing the shield 208 and the stopper 134 to contact the lower contents of the container 130. 当上和下穿刺202、204已经分别接触上部120和下容器130的内容物时,就在上容器120和下容器130之间产生流动路径。 When the upper and lower puncture 202,204 respectively have upper contacting the contents of lower container 120 and 130, the generated flow path between the container 120 and lower container 130. '967申请讨论了组件110的其它内部机构,这些内部机构确保上容器120朝着上部穿刺202行进,并且在下部穿刺204能够接触下容器130的下瓶塞134之前,上瓶塞124被上部穿刺202完全刺穿。 Before the '967 application discusses other internal mechanism assembly 110, these means ensure that the container interior 120 travels toward the upper puncture 202, and 204 can be in contact with the vessel puncture the stopper 134 130 in the lower, the upper stopper 124 is punctured 202 completely pierced.

[0038] 图4例示了在运送(未激活状态)期间,容器120和130如何配合在药物重组组件100 的外壳110中,以及药物重组组件110如何配合在包装主体14的内部腔室中。 [0038] FIG. 4 illustrates during transport (inactive state), the container 120 and 130 how to fit a medicament recombinant assembly housing 110 100, and to pharmaceutical recombinant assembly 110 how to fit inside the cavity of the package body 14. 如图所示,上容器120至少部分地配合在上壳体部分112中。 As shown, the container 120 is at least partially fitted in the housing section 112. 上小瓶121的上缘126和上瓶塞124都被朝着转移套装组件200和上穿刺202定向。 On the upper edge 126 of the vial 121 and the stopper 124 are oriented toward the puncture 202 and 200 on the transfer set assembly. 在所示的未激活状态中,上容器120的上瓶塞124被布置成靠近上穿刺202,但是不接触上穿刺202。 In the inactive state shown in the upper stopper 120 of the container 124 is arranged close to the puncture 202, 202 but not in contact with the puncture.

[0039] 在一个实施例中的上壳体部分112包括绕上壳体部分112基本均匀地径向布置的三个孔116,如图2中部分所示。 [0039] In one embodiment, the housing portion 112 includes three apertures 116 around the upper portion of the housing 112 substantially uniformly radially disposed, as shown in Figure 2 in part. 应明白,可在上壳体部分112中包含任何数目的孔,并且间隔不需要相等或为径向的。 It should be appreciated, it may include any number of holes in the upper housing portion 112, and need not be equal interval or the radial. 上壳体部分112形成为使得,当上容器120被固定在其运送构造下时,上小瓶121的各个部件,诸如上肩部122b、上颈部122a和上缘126都与孔116纵向对准。 Upper housing portion 112 is formed such that, when the container 120 is secured in its transport configuration, the various components of the vial 121, such as a shoulder 122b, 122a and the upper edge of the neck 126 are aligned with the longitudinal bore 116 .

[0040] 与上容器120类似,下容器130至少部分地配合在下壳体部分114中。 [0040] Similar to the container 120, the container 130 at least partially engages the lower portion 114 of the housing. 下小瓶131的下缘138和下瓶塞134都被朝着转移套装组件200的下穿刺204定向。 The lower edge 138 of the vial 131 and the stopper 134 are oriented toward the lower transition 204 piercing assembly 200 set. 在未激活状态(如图所示)中,下容器130的下瓶塞134被布置成靠近下穿刺204,但是不接触转移器组件200的下穿刺204。 In the inactive state (as shown), the lower container 134 of the stopper 130 is disposed close to the puncture 204, but does not contact the transfer assembly 200 puncture 204.

[0041] 在一个实施例中的下壳体部分114包括绕下壳体部分114均匀地径向布置的六个孔118,如图2中部分所示。 [0041] In a 118, as shown in the lower part of the second embodiment housing portion 114 includes a portion 114 of the embodiment six holes are uniformly arranged radially around the lower housing of FIG. 可在下壳体部分114中包含任何数目的孔,并且所述任何数目的孔不需要被相等或为径向地间隔。 It may include any number of holes in the lower housing portion 114, and any number of the apertures need not be equally spaced or radially. 在图4中,下壳体部分114的孔118中的两个孔118可见。 In Figure 4, the bore 118 is visible in housing portion 114 two holes 118. 下壳体部分114形成为使得,当下容器130被固定在其运送构造下时,下小瓶131的各个部件, 诸如下肩部132b、下颈部132a和下缘136都与孔118纵向对准。 Lower housing portion 114 is formed such that, 130 is fixed in its transport configuration, the various components of the moment the vial container 131, such as a lower shoulder 132b, 132a and a lower edge of the lower neck 136 are aligned with the longitudinal bore 118.

[0042] 重要的是,在用户有意地激活药物重组组件100之前,上容器120和下容器130不移动脱离它们的运送构造。 [0042] Importantly, the activation of the drug until the user intentionally recombinant assembly 100, upper container 120 and lower container 130 is not moved from their transport configuration. 运送、搬运或误搬运导致的上容器120或下容器130的这种不希望的位移,会导致上穿刺202或下穿刺204与相应的上瓶塞124或下瓶塞134之间过早的接触。 Shipping, handling or due to erroneous handling of such container on the lower container 120 or 130 undesired displacement, will cause the Puncture 202 or 204 between the contact premature respective upper or lower stopper 124 and the stopper 134 . 甚至是,相应的穿刺202和204导致的较薄防护罩206和208的破裂或干扰也能够破坏通过转移套装组件200的穿刺202和204行进的流动路径的无菌环境。 Even if the respective thin puncture 202 and 206 and shield 208 204 rupture or interference can be caused by destruction of the transfer set assembly 200 and 202 puncture the sterile environment of the flow path 204 travel. 如下文更详细讨论的,包装10 防止这些不希望的位移。 Discussed in more detail below, the package 10 prevents these undesirable displacement.

[0043] 应明白,对于本公开,不希望的位移定义的是下列部件的多个不同结果位置中的任何一个结果位置,即:上容器120和下容器130、上202和下204穿刺、上瓶塞124和下瓶塞134、上防护罩206和下防护罩208、转移套装组件200和外壳110。 [0043] It should be appreciated, with the present disclosure, the definition of undesirable displacement is a result of any of a plurality of different position results in the positions of the following components, namely: the container 120 and lower container 130, upper 202 and lower 204 puncture the stopper 124 and a lower stopper 134, the shield 206 and lower shield 208, the transfer set assembly 200 and the housing 110. 通过主体14与药物重组组件100的相互作用,防止了能够在运送期间意外发生的不希望的位移位置中的每一个。 Drug interaction with the body 14 by recombinant assembly 100 prevents undesired displacement of each position is possible accident during the conveyance. 下文描述的是几种不希望的位移位置。 Described below are several undesirable displacement position. 应明白,虽然关于上和下容器两者讨论,但是预期每个不希望的位移位置都单独地或共同地应用于上部120和下部130容器。 It should be understood, although on both the upper and lower container discussions, it is contemplated that the undesired displacement position of each individually or collectively applied to the upper 120 and lower portion 130 of the container.

[0044] 在第一不希望的位移位置中,上容器120或下容器130相对于转移套装组件200轴向偏移,使得上瓶塞124或下瓶塞134与上防护罩206或下防护罩208接触,上防护罩206或下防护罩208继而接触且分别至少部分地被上穿刺202或下穿刺204刺穿。 [0044] In a first undesired displacement position, the container 120 or container 130 with respect to the transfer set assembly 200 axially offset, so that the stopper 124 or the stopper 134 and the upper shield 206 or the lower guard contacts 208, 206, or the protective cover guard 208, respectively, and then contacting the at least partially stuck in the puncture 204 or 202 at the piercing. 应明白,在第一不希望的位移位置中,相应的穿刺202、204不完全穿透上瓶塞124或下瓶塞134。 It should be appreciated, the undesired displacement of the first position, corresponding to the puncture 202 is not completely penetrate the cork stopper 124 or 134. 在第一不希望的位移位置中,上防护罩206和下防护罩208被相应的上部穿刺202和下部穿刺204刺穿,使得转移套装组件200及其流动路径易受污染。 Undesired displacement of the first position, the upper shield 206 and lower shield 208 are respective upper and lower puncture 202 204 pierce the piercing, so that transfer set assembly 200 and the flow path susceptible to contamination.

[0045] 在第二不希望的位移位置中,上容器120或下容器130相对于转移套装组件200轴向移动,使得上瓶塞124或下瓶塞134分别与上防护罩206或下防护罩208接触。 [0045] In the undesired displacement of the second position, the container 120 or 200 under the container 130 for axial movement of the transfer set assembly, such that the stopper 124 or the stopper 134 and protective cover 206 or the lower shield 208 contacts. 上防护罩206 或下防护罩208继而通过相应容器的轴向平移而被压在上穿刺202或下穿刺204上。 The protective cover 206 or puncture the protective cover 204 208 in turn is pressed by the axial translation of the respective container in the puncture 202 or lower. 在第二不希望的位移位置中,上穿刺202或下穿刺204都完全刺穿相应的防护罩206、208,且至少部分地刺穿相应容器120、130的瓶塞124、134。 Undesired displacement in the second position, the upper 202 or lower 204 Puncture completely pierce the corresponding shield 206, 208 and at least partially piercing the stopper of the respective container 124, 134 120, 130. 在各种实施例的第二不希望的位移位置中,穿刺202、204完全刺穿相应瓶塞124、134。 In a second undesired displacement position of the various embodiments, corresponding puncturing pierceable stopper 202, 204, 124, 134 completely. 在第二不希望的位移位置中,上瓶塞124或下瓶塞134被上穿刺202或下穿刺204部分或完全刺穿,导致转移套装组件200的污染机会、以及容器120或130的内容物的污染机会增大。 Undesired displacement in the second position, the stopper 124 on the stopper 134 or 202 or puncture the puncture 204 piercing entirely or partially, resulting in the chance of contamination of the transfer set assembly 200, and the contents of the container 120 or 130 the chance of contamination increases.

[0046] 在第三不希望的位移位置中,上容器120或下容器130相对于外壳110径向或轴向偏移,从而导致小瓶121、131和外壳110内部之间的密封失效。 [0046] In a third undesired displacement position, the container 120 or the container 130 relative to the housing 110 radially or axially offset, resulting in a seal between the interior of the vial 121, 131 and the housing 110 failure. 在第三不希望的位移位置中, 失效密封能够降低上容器120和下容器130在外壳110中的稳固定位,由此提高过早的轴向平移的可能性,并且导致另外的不希望的位移位置。 In a third undesired displaced position, seal failure can be reduced to the container 120 and lower container 130 securely positioned in the housing 110, thereby increasing the likelihood of premature axial translation, and other undesirable results in displacement position.

[0047] 在将可移动盖子12附接至主体14之前,药物重组组件100被插入主体14的内部腔室中。 [0047] Before the movable cover 12 attached to the body 14, assembly 100 is inserted into a recombinant drugs inside the chamber body 14. 在此期间,突起16和18以及井状部20a至20c、22和24匹配药物重组组件100所包括的、 以及被保持在药物重组组件100内的上容器120和下容器130的不同部件。 During this time, the projections 16 and 18 and the different member shaft portion 20a to 20c, 22 and 24 comprises a matched assembly of recombinant medicament 100, and the medicament container is held within the assembly 100, 120 and recombinant lower container 130.

[0048] 现在参考图5和6,进一步例示了突起和井状部。 [0048] Referring now to FIGS. 5 and 6, and further illustrates the projecting shaft portion. 井状部20a、20b和20c从主体14向外延伸,且形成基本共面表面,能够在该基本共面表面上支撑组件10。 The well portions 20a, 20b and 20c extending outwardly from the body 14, and is formed substantially coplanar with the surface to support the assembly 10 in the substantially coplanar surfaces. 井状部20c成型为基本匹配药物重组组件100的注射器端口塞140的轮廓形状。 The well portion 20c shaped to substantially match the medicament port 100 of the syringe assembly recombinant contour shape of the plug 140. 在运送位置中,注射器端口塞140 向下面朝着组件的底部,以匹配井状部20c。 In the transport position, the syringe port 140 below the bottom of the plug towards the assembly to match the well portion 20c. 注射器端口塞140与井状部20c的接合抑制了端口在主体14内的旋转移动。 Engaging the syringe port 140 and plug the well portion 20c inhibits rotational movement within the body 14 of the port. 注射器端口塞140也匹配井状部20c,以在外壳100上提供相对于主体14的附加轴向约束。 Syringe port plug 140 also matches the well portion 20c, to provide an additional axial constraint with respect to body 14 on the housing 100. 将注射器端口塞140向下朝着组件100的下端定向防止了用户在向后剥下可移除盖子12时,通过注射器端口塞140移除药物重组组件100,这能够导致塞140从注射器端口意外分离的可能性增大。 The syringe port 140 downwards towards the lower end of the plug assembly 100 prevents the user orientation when peeling back the cover 12 may be removed, removal of the drug recombinant assembly 100 via syringe port plug 140, port 140 which can result from accidental syringe stopper possibility of separation increases. 反而,应刚好在通过外部注射器连接组件100之前,移除注射器端口塞140。 Instead, should be connected via an external syringe just prior to assembly 100, the injector port plug 140 is removed.

[0049] 图5例示了两个突起16从包装主体14向内延伸到主体的内部腔室中。 [0049] Figure 5 illustrates an interior chamber 16 extending from two projecting inwardly into the package body 14 of the main body. 如图6中所示,突起16包括几个几何外形部件,这几个几何外形部件形成为与药物重组组件100的匹配部件协作。 As shown in FIG. 6, the protrusion 16 comprises several part geometry, these geometry member is formed to cooperate with a mating member assembly 100 recombinant drugs. 特别地,每个突起16都包括多个面,包括渐缩面16a、盖子侧面16b、主体侧面16c、 上面16d和下面16e。 In particular, each projection 16 includes a plurality of faces, including a tapered surface 16a, a side cover 16b, the side body 16c, and 16d below the top 16e. 图1至6清楚示出,两个突起16从主体14的外部,在主体14的纵向中心的任一侧上间隔相等地延伸。 1 to 6 clearly shown, two projections 16, 14 extending from the outer body on either side of the longitudinal center of the body 14 are equally spaced.

[0050] 图2示出药物重组组件100如何配合在主体14内的分解图。 [0050] FIG. 2 shows how the fitting 100 within the body 14 an exploded view of the assembly of recombinant drugs. 当药物重组组件100被插入主体14中时,两个突起16穿过上壳体部分112的两个相应孔116延伸。 When the body 100 is inserted in the pharmaceutical recombinant assembly 14, two projections 16 passing through two corresponding holes 112 of the housing portion 116 extends. 如图4中所示,突起16穿过孔116朝着上容器120延伸。 As shown in FIG. 4, the projections 16 extend through the apertures 116 toward the container 120. 特别地,突起16的主体侧面16c被构造和布置用以接合形成孔116的上壳体部分112的侧面116a,突起16的盖子侧面16b被构造和布置用以接合形成孔116的上壳体部分112的侧面116b,上面16d被构造和布置用以接合形成孔116的上壳体部分112的侧面116c,并且下面16e被构造和布置用以接合形成孔116的上壳体部分112的侧面116d。 In particular, the body side surface 16c of the projection 16 is constructed and arranged to engage the housing upper side surface 116a of the hole 116 formed in section 112, the lid side surface 16b of the protrusion 16 is constructed and arranged to engage holes formed in the upper housing portion 116 the side surface 112 116b, the top 16d is constructed and arranged to engage the housing bore 116 formed in the side surface portion 112 is 116c, and the following 16e is constructed and arranged to engage the side surface 116d formed on the housing portion 112 of the hole 116.

[0051] 突起16和孔116之间的接合防止药物重组组件100在主体14内轴向平移或者旋转。 [0051] The engagement between the projection 16 and the hole 116 to prevent drug recombinant assembly 100 within the body 14 axially translate or rotate. 特别地,盖子侧面16b接触形成孔116的上壳体部分112的侧面116b,并且主体侧面16c接触形成孔116的上壳体部分112的侧面116a,以防止药物重组组件100在主体14内旋转。 In particular, the side surface cap 16b are formed on the side surface of the contact hole 116 of the housing portion 112 of the 116b, and the body contacting side surface 16c is formed on the side surface of the housing portion 112 of the hole 116 116a, in order to prevent drug recombinant assembly 100 is rotated within the body 14. 类似地,下面16e接触形成孔116的上壳体部分112的侧面116d,并且上面16d接触形成孔116的上壳体部分112的侧面116c,以防止药物重组组件100在主体14内轴向平移。 Similarly, following the contact 16e is formed on the side surface 116d of the housing bore 116 of the portion 112, and contacts the upper side surface 16d is formed on the housing portion 112 of the hole 116 116c, to prevent drug recombinant assembly 100 translates axially in the body 14.

[0052] 在各种实施例中,突起16不需要在与上容器120的上小瓶121物理接触的同时,持续地与孔116的侧面116c、116d接触或与孔116的侧面116c、116d有任何接触。 [0052] In various embodiments, the projections 16 need not be at the same time in contact with the vial 121 physically container 120, continuous side surface 116c, 116d contact the sides of the hole 116 or hole 116 116c, 116d of any contact. 应明白,突起16有助于将上容器120稳固地保持在上壳体部分112内,这是因为突起16抑制了上容器120 的任何轴向偏移,并且由同一突起16抑制孔116 (即,上壳体部分112)的任何轴向偏移。 It should be appreciated, the projection 16 helps to securely retain the container 120 within the upper housing portion 112, since the projection 16 on the container to suppress any axial offset 120, and the protrusion 16 by the same restraining hole 116 (i.e. , any axial upper housing portion 112) is offset. 由于突起16在孔116之间且在上容器120的上小瓶121的颈部122a和边缘126之间延伸,所以突起16且因此主体14防止上容器120相对于上壳体部分112的轴向偏移。 Since the projections 16 extend between the hole 116 and between the neck of the vial container 120 and the edge 122a 121 126, the projections 16 and the body 14 thus preventing the container 120 relative to the upper housing portion 112 is axially biased shift.

[0053] 与上述突起16类似,主体14也在其下端处包括两个突起18,这两个突起18从主体14向内延伸到主体的内部腔室中。 [0053] Similar to the projection 16, the body 14 also includes at its lower end two projections 18, two projections 18 extending inwardly from the body 14 into the interior of the chamber body. 在图6中,更详细地示出突起18中的一个。 In FIG. 6, illustrating in greater detail a protrusion 18. 与突起16相同, 突起18包括几个几何外形部件,这些几何外形部件被确定尺寸且相对于主体14布置,从而在被插入包装10中时,与药物重组组件100的匹配部件协作。 Identical to the projections 16, the projections 18 comprise several part geometry, the geometry and the member is dimensioned relative to the body 14 is arranged so that when the package 10 being inserted, cooperate with the mating member assembly 100 recombinant drugs. 特别地,突起18包括渐缩面18a、盖子侧面18b、主体侧面18c、下面18d和上面18e。 In particular, the projection 18 includes a tapered surface 18a, a side cover 18b, the side body 18c, and 18d below the top 18e. 图1至6清楚示出,两个突起18从主体14向内,在主体14的纵向中心的任一侧上间隔相等地延伸。 1 to 6 clearly shown, two projections 18 extending inwardly from the body 14 on either side of the longitudinal center of the body 14 are equally spaced.

[0054] 图2示出当药物重组组件100被插入主体14中时,两个突起18穿过下壳体部分114 的两个相应孔118延伸。 [0054] Figure 2 shows a time 14, when the extension 100 is inserted into the body assembly recombinant drugs two projections 18 of the two respective hole portions 114 through the lower housing 118. 如图4中所示,突起18穿过孔118朝着下容器130延伸。 As shown in FIG. 4, the protrusion 118 extends through the hole 18 toward the lower container 130. 特别地,突起18的主体侧面18c被构造用以接合形成孔118的下壳体部分114的侧面118a,突起18的盖子侧面18b被构造用以接合形成孔118的下壳体部分114的侧面118b,下面18d被构造用以接合形成孔118的下壳体部分114的侧面118c,并且上面18e被构造用以接合形成孔118的下壳体部分114的侧面118d。 In particular, the body side surface 18c of the protrusion 18 are configured to engage holes formed in the side surface of the lower housing portion 114 118 118a, the projection 18b of the cover side 18 is configured to engage holes formed in the side surface of the lower housing portion 114 118 118b the following 18d configured to engage holes formed in the side surface of the lower housing 118 118c portion 114, and is configured to engage the top 18e is formed at the side surface 118d of the housing portion 114 of the bore 118.

[0055] 突起18和孔118之间的接合防止药物重组组件100在主体14内轴向平移或者旋转。 [0055] The engagement between the projection 18 and the hole 118 to prevent drug recombinant assembly 100 within the body 14 axially translate or rotate. 特别地,盖子侧面18b接触形成孔118的下壳体部分114的侧面118b,并且主体侧面18c接触形成孔118的下壳体部分114的侧面118a,以防止药物重组组件100在主体14内旋转。 In particular, the cover flank contact hole 18b formed in the side surface 118 of the lower housing portion 114 118b, and the body side surface of the contact hole 18c formed in the side surface 118 of the lower housing portion 114 118a, in order to prevent drug recombinant assembly 100 is rotated within the body 14. 类似地,下面18d接触形成孔118的下壳体部分114的侧面118c,并且上面18e接触形成孔118的下壳体部分114的侧面118d,以防止药物重组组件100在主体14内轴向平移。 Similarly, following the contact hole 18d formed in the lower case 118 a side portion 114 118c, and 118d contact with the upper side surface 18e formed in the lower portion 114 of housing bore 118 so as to prevent drug recombinant assembly 100 within the body 14 axially translate.

[0056] 在各种实施例中,突起18不需要在与下容器130的下小瓶131物理接触的同时,持续地与孔118的侧面118c、118d接触或与孔118的侧面118c、118d有任何接触。 [0056] In various embodiments, projection 18 need not be at the same time in contact with the lower container 130 of the vial 131 physical, continuous side surfaces 118c, 118d contact the sides of the bore hole 118 or 118 118c, 118d of any contact. 应明白,突起18有助于将下容器130稳固地保持在下壳体部分114内,这是因为突起18抑制了下容器130 的任何轴向移动,并且由同一突起18抑制孔118 (S卩,下壳体部分114)的任何轴向移动。 It should be appreciated, the projection 18 helps to securely hold the container 130 within the lower housing portion 114, since the projection 18 preventing any axial movement of the container 130, and the restraining hole 18 by the same protrusion 118 (S Jie, any axial lower housing portion 114) is moved. 由于突起18在孔119之间并且在下容器130的下小瓶131的颈部132a和边缘136之间延伸,所以突起18且因此主体14防止下容器130相对于下壳体部分114的轴向移动。 Since the projection 18 between the bore 119 between the vial neck 131 of the container 130 and the edge 132a and the lower extension 136, so that the projections 18 and the body 14 thus preventing the container 130 axially relative to the lower housing portion 114 moves.

[0057] 因此,突起16和18协同工作,以防止药物重组组件100的外壳110在包装10内的轴向和旋转移动两者。 [0057] Thus, the projections 16 and 18 work together to prevent both the axial pharmaceutical recombinant assembly 100 within the housing 110 and the rotational movement of package 10. 虽然例示了每两个突起16和18分别匹配每两个孔116和118,但是其它实施例包括每一个突起16和18匹配一个相应的孔116和118,或者超过每两个突起16、18匹配超过两个相应的孔116、118。 While each embodiment illustrates the two projections 16 and 18 respectively matching each of the two holes 116 and 118, although other embodiments include a projection 16 and 18 each match a corresponding one of holes 116 and 118, or more than two protrusions 16, 18 each match more than two corresponding holes 116, 118. 应明白,出于在'967申请中所更详细讨论的原因,药物重组组件100中的内部机构和摩擦用于相对于外壳110固定上容器120和下容器130。 It should be appreciated, for reasons discussed in more detail in the '967 application, the pharmaceutical recombinant assembly 100 and the internal friction mechanism 110 for fixing the housing relative to the container 120 and lower container 130.

[0058] 在各种实施例中,如果上容器120或下容器130绕药物重组组件100的纵向轴线径向移动,就能够危害在' 967申请中更详细描述的各种内部密封件或组件。 [0058] In various embodiments, if the container 120 or container 130 about the longitudinal axis of the recombinant pharmaceutical radial movement assembly 100, can be harmful in various internal '967 application described in more detail or seal assembly. 应明白,突起20c、 16和18协作,以防止上容器120或下容器130在外壳110中,或者药物重组组件100的任何其它部件在包装10中的意外的旋转移动。 It should be appreciated, the projections 20c, 16 and 18 cooperate to prevent accidental rotational movement of the container on the lower container 120 or 130 in the housing 110, or any other component of the drug in the recombination assembly 100 package 10.

[0059] 再次参考图3至6,进一步讨论和例示主体14与容器120的上小瓶121和下容器130 的下小瓶131中的每一个之间的匹配关系。 [0059] Referring again to FIGS. 3-6, a matching relationship between each of the further discussion and illustration of the container body 120 on the vial 14 in the vial 131 121 and 130 in the lower container. 除了突起16与外壳110的孔116以及突起18与外壳110孔118之间相互作用以防止上述外壳110的运动之外,突起16也匹配上小瓶121的不同部件,而突起18也匹配下小瓶131的不同部件,以防止上容器120和下容器130的明显运动。 In addition to the housing 16 between the bore 116 and 110 of the aperture 110 of the housing projection 18 interacts with the projection 118 of the housing 110 to prevent movement other than the protrusion member 16 also match the different vials 121, and the projection 18 also matches the vial 131 different members to prevent significant movement of the container 120 and lower container 130. 为了该目的,突起16和18都穿过相应孔116和118延伸,以接触上小瓶121和下小瓶131。 For this purpose, the projections 16 and 18 extend through corresponding holes 116 and 118, 121 to contact the vial and the vial for 131. 在各种实施例中,上容器120和下容器130关于外壳110且更具体地分别关于上壳体部分112和下壳体部分114的轴向平移被下列接合阻止,S卩:突起16同时与上小瓶121和孔116的接合、以及突起18同时与下小瓶131和孔118的接合。 In various embodiments, the container 120 and lower container 130 on the housing 110, respectively, and more specifically on the axial upper housing portion 112 and a lower housing portion 114 joined to prevent translation of the following, S Jie: projection 16 and simultaneously the vial 121 and engaging hole 116, and the engagement projection 18 while the lower apertures 131 and 118 of the vial.

[0060] 如上所述,上容器120和下容器130被布置成使得,上小瓶121和下小瓶131的各自肩部122b、132b、颈部122a、132a和边缘126、136分别与孔116、118中的每一个对准。 [0060] As described above, the upper container 120 and lower container 130 are arranged such that, on the vial 121 and the vial 131 at respective shoulders 122b, 132b, the neck portion 122a, 132a, respectively 126, 136 and edge holes 116, 118 each of the alignment. 在所示实施例中,突起16被构造成接触上小瓶121的三个不同部分,即肩部122b、颈部122a和边缘126。 In the illustrated embodiment, three protrusions 16 are configured to contact different portions of the vial 121, i.e. the shoulder 122b, the neck portion 126 and the edge 122a. 类似地,突起18接触下小瓶131的三个不同部分,即肩部132b、颈部132a和边缘136。 Similarly, the projection 131 of the three different parts of the lower contact vials 18, i.e. the shoulder 132b, the neck portion 136 and the edge 132a. 图2 示出了端口塞140确保了孔116和118被适当旋转,以分别接纳突起16和18。 Figure 2 shows a plug 140 to ensure that the port holes 116 and 118 are properly rotated to receive the projections 16 and 18 respectively.

[0061] 主体14的突起16的渐缩部分16c被构造成沿上小瓶121的肩部122b的轮廓,并且因此保持肩部122b。 [0061] The body 14 of the protrusion 16 of the tapered portion 16c is configured to move along the contour of the shoulder portion 122b of the vial 121, and thus holding the shoulder 122b. 同样地,主体14的突起18的渐缩部分18c被构造成沿下小瓶131的肩部132b的轮廓,并且因此保持肩部132b。 Similarly, the projection 14 of the body portion 18c tapering shoulder portion 132b is configured to contour along the 18 vial 131, and thus holding the shoulder 132b. 对应地,渐缩部分16a、18a也用于支撑上小瓶121和下小瓶131中的每一个,以便防止相应的上容器120和下容器130在包装10内的明显的平移移动。 Correspondingly, the tapered portion 16a, 18a is also used to lower the vial 121 and vial 131 in each of the upper support 130 so as to prevent significant translational movement of the respective upper container 120 and lower container 10 within the package. 为了防止小瓶移动至不希望的位移位置,应明白,在各种实施例中,渐缩部分16a、18a不需要接触带轮廓的肩部122b、132b。 In order to prevent undesired movement of the vial displacement position, to be understood that, in various embodiments, the tapered portions 16a, 18a without contacting the shoulder belt profile 122b, 132b. 由于肩部122b、132b的带轮廓性质以及渐缩部分16a、 16b的相应渐缩形状,上容器120和下容器130被推压而克服相对于主体14和外壳110的偏移。 Since the shoulder belt profile properties 122b, 132b, and tapered portions 16a, 16b corresponding to the tapered shape of the upper container 120 and lower container 130 is pressed against the body 14 and offset with respect to the housing 110. 主体的带轮廓形状也提供了紧抱效果,该效果确保了上小瓶121和下小瓶131与主体14 之间的滑动配合。 Contoured shape of the body also provides clinging effect that ensures a snug fit between the vial 131 and the vial 121 and the lower body 14.

[0062] 在各种实施例中,主体14的突起16的盖子侧面16b被布置成朝着上小瓶121的边缘126和肩部122b之间的上小瓶121的颈部122a延伸。 [0062] In various embodiments, the body side protrusion 14 of the lid 16 toward 16b are arranged on the vial 121 between the edge 126 and the shoulder 122b, 122a on the vial neck 121 extends. 楔入边缘126和肩部122b之间的盖子侧面16b进一步用于防止上容器120在包装10内的平移移动。 Wedging between the sides of the cover edge 126 and the shoulder 122b 16b to prevent further translational movement of the container 120 within the package 10. 类似地,突起18的盖子侧面18b被构造成朝着下小瓶131的边缘136和肩部132b之间的下小瓶131的颈部132b延伸。 Similarly, the projection 18b of the cover side 18 is configured to extend toward the neck portion 132b of the vial 131 between the lower edge 136 and shoulder 132b of the vial 131. 楔入边缘136和肩部132b之间的盖子侧面18b进一步用于防止下容器130在包装10内的平移移动。 Wedged between the side edges of the lid 136 and the shoulder 132b 18b to prevent further translational movement of the container 130 within the package 10. 为了防止小瓶移动至不希望的位移位置,应明白,在各种实施例中,盖子侧面16b、18b不需要持续接触边缘126、136和肩部122b、132b。 In order to prevent undesired movement of the vial displacement position, to be understood that, in various embodiments, the cover side surface 16b, 18b do not need to continuously contact edges 126, 136 and the shoulder 122b, 132b.

[0063] 应明白,虽然转移套装组件200不必为上部外壳112或下部外壳114的一部分,但是部分由于转移套装组件200在注射器端口处的连接,所以转移套装组件200确实相对于外壳保持静止。 [0063] It should be understood that while the transfer set assembly 200 is not necessarily part of the upper housing 112 or lower housing 114, but since the portion of the transfer set assembly connector 200 at the syringe port, so does the transfer set assembly 200 remains stationary relative to the housing. 因此,应明白,对于关于容器120、130和外壳100的上述类似原理,主体14及其突起16、18也起防止上容器120和下容器130相对于转移套装组件200轴向平移的作用。 Thus, it should be understood that the above-described container on a similar principle housing 120, 130 and 100, the main body 14 and projections 16, 18 also act to prevent the container 120 and the transfer set assembly 130200 axially translatable relative to the effect on the container.

[0064] 另外,由于形成于主体14中的锥形面116a、118a的定向,如果有什么的话,则推压上容器120和下容器130,使之远离转移套装组件200。 [0064] Further, since the tapered surface is formed on the orientation of the body 14 116a, 118a, and if anything, is pressed onto the container 120 and lower container 130, so as to divert away from the package assembly 200. 如图4和6中所示,相应上小瓶121和下小瓶131的肩部122b、132b分别坐放在轮廓116a、118a上,轮廓116a、118a成一角度,以便在缺乏所有其它轴向障碍物时,上容器120和下容器130也将不能向内,或者朝着转移套装组件200,并且具体是朝着上穿刺202和防护罩206以及下穿刺204和防护罩208偏移,并且进入不希望的位移位置。 When as shown in FIG. 4 and 6, the corresponding shoulder 121 on the vial and the vial 131, 122b, 132b are seated in the profile 116a, the 118a, contour 116a, 118a at an angle to the axial direction in the absence of all other obstructions , upper container 120 and lower container 130 will not be inwardly or toward the transfer set assembly 200, and particularly towards the puncture 202 and 206 and the lower shield 204 and shield 208 puncture offset, and into undesirable displacement position. 应明白,至少出于阻止上容器120和下容器130相对于转移套装组件200 轴向平移的相同原因,阻止上容器120和下容器130相对于彼此轴向平移。 It should be understood, at least for preventing the container 120 and lower container 130 with respect to the same reasons as the transfer set assembly 200 axially translatable, prevents the container 120 and lower container 130 translate axially relative to one another.

[0065] 主体14的端部部分22形成为,当被装配到包装10中时,支撑和约束药物重组组件100的不同部件。 [0065] The end portion 22 of the body 14 is formed, as when the support member and the different constraints recombinant drugs assembly 100 is fitted to the package 10. 图4示出了主体14的端部部分22被构造成:通过限制上小瓶121的向上轴向移动,来约束上容器120。 FIG. 4 shows an end portion 14 of the body 22 is configured to: axially upward movement of the vial through the limits of 121, 120 to restrain the container. 端部部分22也支撑上小瓶121的基部部分122c。 End portion 22 is also supported on the base 121 of the vial portion 122c. 类似地,主体14的端部部分24被构造成:通过限制下小瓶131的向下轴向移动,来约束下容器130。 Similarly, the end portion 24 of the body 14 is configured to: move axially downward through the lower limit of the vial 131, the container 130 is constrained. 端部部分24 也支撑下小瓶131的基部部分132c。 24 also supports an end portion of the base portion 131 of the vial portion 132c. 应明白,一些实施例包括主体14,主体14的公差是这样的,使得端部部分22、24分别接触或接近接触上小瓶121和下小瓶131的相应底部。 It should be appreciated, some embodiments includes a body 14, tolerance of body 14 is such that the end portions 22, 24 are in contact or near the bottom of the vial 121 and respective vials 131 under the upper contact. 在各种实施例中,端部部分22、24不分别接触上小瓶121和下小瓶131的底部。 In various embodiments, the end portions 22, 24 are not in contact with the bottom of the vial 121 and the vial 131.

[0066] 通过上述讨论应明白,形成的主体14的几何外形和部件在多个接触位置处与下列部件相互作用:(i)药物重组组件100,以防止药物重组组件100旋转和平移运动;和(ii)上容器120和下容器130,以防止上容器120和下容器130旋转和平移地移动至不希望的位移位置。 [0066] It should be appreciated from the above discussion, geometry, and the body member 14 formed at a plurality of positions in contact with the interaction of the following components: (i) a pharmaceutical recombinant assembly 100, assembly 100 to prevent drug recombinant rotational and translational movement; and (ii) the container 120 and lower container 130 to prevent rotation of the container 130 and lower container 120 to move translationally and undesired displacement position.

[0067] 本文所述的主旨的各方面可单独使用,或者可与本文中所述的一个或多个其它方面组合使用。 [0067] Aspects of the subject matter described herein may be used alone, or may be described herein according to one or more other aspects thereof. 在不限制上述说明的情况下,在本公开的第一方面中,一种医疗包装组件包括:药物重组组件,该药物重组组件包括(i)形成至少一个孔的外壳、(ii)被至少部分地放置在外壳的内部中的容器和(iii)被布置在外壳内以便能够穿刺容器的穿刺组件;和主体, 该主体被成型以便容纳药物重组组件,该主体包括穿过孔延伸并延伸到外壳的内部中的至少一个突起,其中该至少一个突起被定位和布置成在容器达到相对于穿刺组件的不希望的位移之前,防止容器朝着穿刺组件移动。 Without limiting the foregoing description, in the first aspect of the present disclosure, a medical package assembly comprising: a drug recombinant assembly, the assembly comprising a recombinant drugs (i) at least one hole formed in the housing, (ii) is at least partially placed in the interior of the housing in the container and (iii) is disposed within the housing so that the container can be punctured puncture assembly; and a body, the body is shaped so as to accommodate a drug recombinant assembly, the body comprising a bore extending through the housing and extends into at least one internal projection, wherein the at least one projection is positioned and arranged before the vessel reaches an undesired displacement relative to the piercing assembly to prevent movement of the container toward the lancing assembly.

[0068] 根据本公开的可结合第一方面使用的第二方面,该第二方面包括盖子,该盖子附接至主体且被构造用以将药物重组组件密封地封闭在主体内。 [0068] The present disclosure may be used in conjunction with a second aspect of the first aspect according to the second aspect comprises a cover attached to the body and configured to seal the drug recombinant assembly enclosed within the body.

[0069] 根据本公开的可结合任一个或多个上述方面使用的第三方面,其中通过热激活粘合剂将盖子附接至主体。 [0069] The present disclosure may incorporate any one or more of the third aspect of the use of the above aspects, wherein a heat activated adhesive through the lid attached to the body.

[0070] 根据本公开的可结合任一个或多个上述方面使用的第四方面,其中该至少一个突起被构造用以防止容器相对于外壳的轴向平移。 [0070] The present disclosure may incorporate any one or more of the fourth aspect of the use of the above aspects, wherein the at least one projection is configured to prevent the container relative to the housing axial translation.

[0071] 根据本公开的可结合任一个或多个上述方面使用的第五方面,其中该至少一个突起进一步防止药物重组组件在主体内旋转。 [0071] The present disclosure may be combined with one or more of any of the fifth aspect of the use of the above aspects, wherein the at least one projection to prevent further rotation of the drug in the body assembly recombination.

[0072] 根据本公开的可结合任一个或多个上述方面使用的第六方面,其中主体构造有至少一个扁平表面,以便防止主体滚动。 [0072] The present disclosure may be combined with one or more of any of the sixth aspect of the use of the above aspects, wherein the body is configured with at least one flat surface, in order to prevent the rolling body.

[0073] 根据本公开的可结合任一个或多个上述方面使用的第七方面,其中药物重组组件包括注射器端口塞,并且主体包括空腔,该空腔成型为匹配药物重组组件的注射器端口塞。 [0073] The present disclosure may be combined with one or more of any of the seventh aspect of the use according to above, wherein the medicament comprises a syringe port recombinant plug assembly, and the body includes a cavity that is shaped to match the syringe port plug assembly recombinant drugs .

[0074] 根据本公开的可结合任一个或多个上述方面使用的第八方面,其中该容器为第一容器,并且本公开包括被至少部分地放置在药物重组组件的外壳内的第二容器,该外壳形成至少一个第二孔,其中该至少一个突起是第一突起,并且本公开包括第二突起,该第二突起被定位和布置成穿过第二孔延伸且延伸到外壳的内部中,并且在第二容器达到相对于穿刺组件的不希望的位移之前,第二突起防止第二容器朝着穿刺组件移动。 [0074] The present disclosure may be combined with one or more of any of the eighth aspect for use according to the above aspect, wherein the container is a first container, and the present disclosure includes a second container is at least partially disposed within the housing assembly recombinant drugs the housing forms at least one second aperture, wherein the at least one projection is a first projection, and the present disclosure includes a second protrusion, the second protrusion being positioned and arranged to extend through the inner bore and extending into a second of the housing and before the second vessel reaches an undesired displacement relative to the lancing assembly, the second projection to prevent movement of the second container in the lancing assembly.

[0075] 根据本公开的可结合任一个或多个上述方面使用的第九方面,其中该容器是包括颈部和肩部的第一小瓶,该第一容器被相对于外壳布置,从而使至少一部分第一小瓶的颈部与所述至少一个第一孔对准,该至少一个第一突起被构造成在第一小瓶达到相对于穿刺组件的不希望的位移之前,朝着颈部延伸,并且接合肩部。 [0075] The present disclosure may incorporate any one or more of a ninth aspect of the use of the above aspects, wherein the container is a vial comprising a first shoulder and a neck portion, the first container is disposed relative to the housing so that at least the vial neck portion of the first aperture aligned with at least one of the first, the at least one first protrusion is configured of the undesirable displacement with respect to the piercing assembly extends toward the neck reaches a first vial, and engages the shoulder.

[0076] 根据本公开的可结合任一个或多个上述方面使用的第十方面,其中该容器是第一容器,且本公开包括被至少部分地放置在药物重组组件的外壳内的第二容器,并且第二容器是包括颈部和肩部的小瓶,外壳形成至少一个第二孔,该第二容器被相对于外壳布置,从而使至少一部分第二容器的颈部与至少一个第二孔对准,其中该至少一个突起是第一突起,并且主体形成第二突起,该第二突起被定位和布置成穿过第二孔延伸并朝着第二容器的颈部延伸到外壳的内部中,并且在第二容器达到相对于穿刺组件的不希望的位移之前, 该第二突起接合第二容器的肩部。 [0076] The present disclosure may incorporate any one or more of the tenth aspect of the use according to above, wherein the container is a first container, and the present disclosure includes a second container is at least partially disposed within the housing assembly recombinant drugs and the second container is a vial comprising a neck and shoulder, the at least one second aperture formed in the housing, the second container is disposed relative to the housing, such that at least a portion of the neck of the second container with at least one second hole pair quasi, wherein the at least one projection is a first projection, a second projection is formed and the body, the second projection being positioned and arranged to extend through the second bore and extending into the interior of the housing towards the neck of the second container, and before the second vessel reaches an undesired displacement relative to the lancing assembly, the second projection engages the shoulder of the second container.

[0077] 根据本公开的可结合任一个或多个上述方面使用的第十一方面,一种药物输送产品包括:药物重组组件,该药物重组组件包括外壳和被放置在外壳内的容器;和包装,该包装包括成型为容纳药物重组组件的主体和从主体延伸的至少一个突起,该至少一个突起被定位和布置用以接合外壳和容器,以阻止容器相对于外壳的轴向平移。 [0077] The present disclosure may incorporate any one or more of the eleventh aspect of the use according to the above aspect, a drug delivery product comprising: a recombinant drugs assembly, the assembly comprising a housing and recombinant drugs are placed in a container within the housing; and package, which comprises a main body shaped to receive medicament from recombinant assembly and the at least one protrusion extending from the body, the at least one projection is positioned to engage and axially housing and the container, the container relative to the housing to prevent translation of the arrangement.

[0078] 根据本公开的可结合第十一方面与一个或多个上述方面任何一项一起使用的第十二方面,其中该容器是第一容器,并且本公开包括被放置在外壳内的第二容器,突起是第一突起,主体包括第二突起,该第二突起被定位和布置成接合外壳,以阻止第二容器相对于外壳的轴向平移。 [0078] The present disclosure may be combined with a twelfth aspect of the eleventh aspect or any one of more of the above with the use, wherein the container is a first container, and the present disclosure includes a first is disposed within the housing second container, the protrusion is a first protrusion, a second body comprises a protrusion, the second protrusion being positioned and arranged to engage the housing, the second container to prevent axial translation relative to the housing.

[0079] 根据本公开的可结合第十一方面与一个或多个上述方面任何一项一起使用的第十三方面,其中第一突起在与第一容器相邻的第一位置处接合外壳,并且第二突起在与第二容器相邻的第二位置处接合外壳。 [0079] The present disclosure may be combined with a thirteenth aspect of the eleventh aspect or any one of more of the above aspects used together, wherein the first projection engages the housing at a first location adjacent to the first container, and the second projection engages the second container housing at a position adjacent to the second.

[0080] 根据本公开的可结合第十一方面与一个或多个上述方面任何一项一起使用的第十四方面,其中第一和第二接合包括第一和第二突起,所述第一和第二突起分别穿过外壳的第一和第二孔延伸。 [0080] The present disclosure may be combined with a fourteenth aspect to the eleventh aspect or any one of more of the above with the use, wherein the first and second engaging comprises first and second protrusions, the first and second protrusions, respectively first and second holes extending through the housing.

[0081] 根据本公开的可结合第十一方面与一个或多个上述方面任何一项一起使用的第十五方面,其中存在下列中的至少其中之一:(i)第一孔是绕外壳径向间隔的多个第一孔中之一,或(ii)第二孔是绕外壳径向间隔的多个第二孔中之一。 [0081] The present disclosure may be combined with a fifteenth aspect of the eleventh aspect or any one of more of the above with the use, wherein at least one of the following: (i) a first aperture is about the housing a plurality of radially spaced first holes in one, or (ii) a second one of the plurality of holes are radially spaced about the housing second holes of.

[0082] 根据本公开的可结合第十一方面与一个或多个上述方面任何一项一起使用的第十六方面,其中穿过第一和第二孔延伸的第一和第二突起进一步阻止外壳相对于主体的旋转移动。 [0082] The present disclosure may be combined with a sixteenth aspect of the eleventh aspect or any one of more of the above with the use, wherein the first and second apertures extending through the first and second projections to prevent further relative to the rotational movement of the housing body.

[0083] 根据本公开的可结合第十一方面与一个或多个上述方面任何一项一起使用的第十七方面,其中第一和第二容器通过转移套装组件来接触,该转移套装组件包括能够由用户接触的端口,主体包括被定位和布置用以接合端口的井状部,或包括塞住该端口的塞子, 从而阻止外壳的轴向移动。 [0083] The present disclosure may be combined with a seventeenth aspect of the eleventh aspect or any one of more of the above with the use, wherein the first and second container by contact transfer set assembly, the transfer assembly includes a set It can be contacted by the user ports, comprising a body and a shaft portion positioned to engage a port arrangement, comprising stoppered or the port, thereby preventing axial movement of the housing.

[0084] 根据本公开的可结合第十一方面与一个或多个上述方面任何一项一起使用的第十八方面,其中药物重组组件通过该至少一个突起的接合也阻止外壳相对于主体的旋转移动。 [0084] The present disclosure may be combined with a eighteenth aspect to the eleventh aspect or any one of more of the above with the use, wherein the medicament recombinant assembly by engaging the at least one protrusion is also prevented from rotating relative to the housing body mobile.

[0085] 根据本公开的可结合第十一方面与一个或多个上述方面任何一项一起使用的第十九方面,其中药物重组组件通过该至少一个突起的接合也阻止外壳相对于主体的轴向运动。 [0085] The present disclosure may be combined with a nineteenth aspect of the eleventh aspect or any one of more of the above aspects used together, wherein the medicament recombinant assembly by engaging the at least one protrusion also prevents the shaft housing relative to the body to sports.

[0086] 根据本公开的可结合一个或多个上述方面任何一项使用的第二十方面,一种包装药物重组组件的方法包括:提供具有可移除盖子和主体的包装,该主体被构造用以容纳药物重组组件,该主体包括从主体延伸的至少一个突起;提供药物重组组件,该药物重组组件具有包括至少一个孔的外壳和被至少部分地设置在外壳内的容器,其中容器的颈部部分与外壳的孔中的至少一个孔对准;将药物重组组件装配在包装的主体内,以便主体的至少一个突起穿过外壳的孔中的至少一个孔延伸,其中药物重组组件在包装内的定向被限制于预定数目的定向;和通过可移除盖子,将药物重组组件密封在包装的主体内。 [0086] The present disclosure may be combined with one or more of any twentieth aspect, a pharmaceutical packaging method of a recombinant component used according to the above aspect comprising: providing a package having a removable lid and body, the body is configured recombinant assembly for receiving the drug, the body comprising at least one protrusion extending from the body; recombinant provides pharmaceutical component, the pharmaceutical recombinant container assembly having a housing and at least partially disposed within the housing comprises at least one hole, wherein the neck of the container the at least one aperture extending recombinant pharmaceutical package assembly fitted within the body so as to protrude through the at least one aperture in the housing body, wherein the medicament recombination within the packaging assembly; at least one hole aligned with the hole portion of the housing of the the orientation is limited to a predetermined number of orientations; and by a removable lid, sealing the drug in the body assembly recombinant package.

[0087] 应理解,本领域技术人员来说,本文所述的当前优选实施例的各种变化和变型是显而易见的。 [0087] It should be understood that those skilled in the art, included in the current that various changes and modifications of the preferred embodiment will be apparent. 能够在不脱离本发明的精神和范围并且不减少其有意优点的情况下,做出这些变化和变型。 It can be made without departing from the spirit and scope of the present invention and without diminishing its advantages deliberately made such changes and modifications. 因此,所附权利要求书旨在涵盖这些变化和变型。 Accordingly, the appended claims are intended to cover such changes and modifications.

Claims (20)

1. 一种医疗包装组件,所述包装组件包括: 药物重组组件,包括: (i)外壳,所述外壳形成至少一个孔, ai)容器,所述容器被至少部分地放置在所述外壳的内部中,和(m)穿刺组件,所述穿刺组件被布置在所述外壳内,以便能够穿刺所述容器;和主体,所述主体成型为容纳所述药物重组组件,所述主体包括穿过所述孔延伸且延伸到所述外壳的内部中的至少一个突起,其中所述至少一个突起被定位和布置用以在所述容器达到相对于所述穿刺组件的不希望的位移之前,防止所述容器朝着所述穿刺组件移动。 1. A medical package assembly, the package assembly comprising: a drug recombinant assembly comprising: (i) a housing forming at least one hole, AI), the container being disposed in said housing at least partially of interior, and (m) the piercing assembly, the piercing assembly is disposed within the housing, so as to be able to puncture the container; and a body shaped to receive said medicament recombinant assembly, said body comprising a through the aperture extends into the interior of said housing and extending at least one protrusion, wherein the at least one projection is positioned and disposed in the container prior to the undesired relative displacement reaches piercing assembly to prevent the said container is moved toward the piercing assembly.
2. 根据权利要求1所述的医疗包装组件,所述包装组件包括盖子,所述盖子附接至所述主体并且被构造用以将所述药物重组组件密封地封闭在所述主体内。 2. The medical packaging assembly according to claim 1, said package assembly comprising a lid attached to the body and configured to seal the drug recombinant assembly enclosed within said body.
3. 根据权利要求2所述的医疗包装组件,其中利用热激活粘合剂将所述盖子附接至所述主体。 The medical package assembly according to claim 2, wherein the thermally activated adhesive cover attached to the body.
4. 根据权利要求2所述的医疗包装组件,其中所述至少一个突起被构造用以防止所述容器相对于所述外壳的轴向平移。 The medical packaging assembly according to claim 2, wherein said at least one projection is configured to prevent axial movement of the container relative to the housing pan.
5. 根据权利要求1所述的医疗包装组件,其中所述至少一个突起进一步防止所述药物重组组件在所述主体内旋转。 5. The medical packaging assembly according to claim 1, wherein the at least one projection to prevent further rotation of said medicament recombinant assembly within the body.
6. 根据权利要求1所述的医疗包装组件,其中所述主体构造有至少一个扁平表面,以便防止所述主体滚动。 The medical packaging assembly according to claim 1, wherein said body is configured with at least one flat surface, so as to prevent rolling of the body.
7. 根据权利要求1所述的医疗包装组件,其中所述药物重组组件包括注射器端口塞,并且所述主体包括空腔,所述空腔成型为匹配所述药物重组组件的所述注射器端口塞。 The medical packaging assembly according to claim 1, wherein said medicament comprises a syringe port recombinant plug assembly, and the body comprises a cavity shaped to match the syringe assembly of the medicament port plug recombinant .
8. 根据权利要求1所述的医疗包装组件,其中所述容器为第一容器,并且所述医疗包装组件包括被至少部分地放置在所述药物重组组件的所述外壳内的第二容器,所述外壳形成至少一个第二孔,其中所述至少一个突起是第一突起,并且所述医疗包装组件包括第二突起,所述第二突起被定位和布置成穿过所述第二孔延伸且延伸到所述外壳的内部中,并且在所述第二容器达到相对于所述穿刺组件的不希望的位移之前,所述第二突起防止所述第二容器朝着所述穿刺组件运动。 8. The medical packaging assembly according to claim 1, wherein said container is a first container and said medical assembly comprising a package is placed in a second container of the medicament within the housing assembly recombinant least partially, said second housing forming at least one aperture, wherein the at least one projection is a first projection, and the medical packaging assembly includes a second protrusion, the second protrusion being positioned and arranged to extend through the second aperture and extending into the interior of the housing, and before reaching the undesirable displacement with respect to the piercing assembly, said second projection prevents the piercing assembly moves towards the second container in the second container.
9. 根据权利要求1所述的医疗包装组件,其中所述容器是包括颈部和肩部的第一小瓶, 所述第一容器被相对于所述外壳布置,从而使所述第一小瓶的至少一部分所述颈部与所述至少一个第一孔对准,所述至少一个第一突起被构造成在所述第一小瓶达到相对于所述穿刺组件的不希望的位移之前,朝着所述颈部延伸并接合所述肩部。 The medical packaging assembly according to claim 1, wherein said container is a vial comprising a first shoulder and a neck portion, the first container is disposed relative to the housing, such that the first vial a neck portion with the at least first aperture aligned with at least a portion of the at least one first protrusion is configured before reaches undesired displacement of the piercing assembly relative to said first vial toward the said neck portion and extending the shoulder engages.
10. 根据权利要求9所述的医疗包装组件,其中所述容器是第一容器,并且所述医疗包装组件包括被至少部分地放置在所述药物重组组件的所述外壳内的第二容器,并且所述第二容器是包括颈部和肩部的小瓶,所述外壳形成至少一个第二孔,所述第二容器被相对于所述外壳布置,从而使所述第二容器的至少一部分所述颈部与所述至少一个第二孔对准, 其中所述至少一个突起是第一突起,并且所述主体形成第二突起,所述第二突起被定位和布置成穿过所述第二孔延伸并朝着所述第二容器的所述颈部延伸到所述外壳的内部中,并且在所述第二容器达到相对于所述穿刺组件的不希望的位移之前,所述第二突起接合所述第二容器的所述肩部。 10. The medical package assembly according to claim 9, wherein said container is a first container, and the assembly comprising the medical packaging is disposed at least partially within the housing of the second medicament container assembly recombinant, and the second container is a vial comprising a neck and a shoulder, the housing forming at least one second hole, the second container is disposed relative to the housing, such that said at least a portion of the second container said neck portion with said at least one second holes are aligned, wherein said at least one projection is a first projection, second projection and the main body is formed, the second protrusion being positioned and arranged to pass through the second before bore extending into the interior of said housing and extending in toward the neck of the second container, and reaches an undesirable displacement with respect to the piercing assembly in said second container, said second projection engaging the shoulder of the second container.
11. 一种药物输送产品,包括: 包括外壳和被放置在所述外壳内的容器的药物重组组件;和包装,所述包装包括成型为容纳所述药物重组组件的主体,和从所述主体延伸的至少一个突起,所述至少一个突起被定位和布置用以接合所述外壳和所述容器,以抑制所述容器相对于所述外壳的轴向平移。 11. A drug delivery products, comprising: a housing assembly including a drug and recombination is placed in a container within the housing; and a package, said package comprising a body shaped to receive said medicament recombinant component, and from said main body extending at least one protrusion, the at least one projection is positioned and arranged to engage said housing and said container, said container to inhibit relative axial translation of the housing.
12. 根据权利要求11所述的药物输送产品,其中所述容器是第一容器,并且所述药物输送产品包括被放置在所述外壳内的第二容器,所述突起是第一突起,所述主体包括第二突起,所述第二突起被定位和布置用以接合所述外壳,以抑制所述第二容器相对于所述外壳的轴向平移。 12. A medicament according to claim 11, wherein the delivery product, wherein said container is a first container and a second product comprising the drug delivery container is disposed within the housing, the projection is a first projection, the said body includes a second protrusion, the second protrusion being positioned and arranged to engage the housing to inhibit the axial direction of the second container relative to the housing translation.
13. 根据权利要求12所述的药物输送产品,其中所述第一突起在与所述第一容器相邻的第一位置处接合所述外壳,并且所述第二突起在与所述第二容器相邻的第二位置处接合所述外壳。 13. The pharmaceutical according to claim 12, wherein the delivery product, wherein said first protrusion engages the housing at a first location adjacent said first container and said second protrusion with said second at a second position of the container adjacent the housing engaged.
14. 根据权利要求12所述的药物输送产品,其中第一和第二接合包括所述第一和第二突起,所述第一和第二突起分别穿过所述外壳的第一和第二孔延伸。 The first and second medicament as claimed in claim 12, wherein the delivery product, wherein said first and second engaging comprises first and second protrusions, said first and second protrusions pass through said housing extends.
15. 根据权利要求14所述的药物输送产品,其中存在下列中的至少其中之一:(i)所述第一孔是绕所述外壳径向间隔的多个第一孔中的其中之一,或(ii)所述第二孔是绕所述外壳径向间隔的多个第二孔中的其中之一。 15. The pharmaceutical according to claim 14 transporting products, wherein at least one of the following: (i) said first aperture is one of a plurality of first holes radially spaced about the housing in , or (ii) wherein one of said second apertures are radially spaced about the housing in a second plurality of holes.
16. 根据权利要求14所述的药物输送产品,其中穿过所述第一和第二孔延伸的所述第一和第二突起进一步抑制所述外壳相对于所述主体的旋转移动。 16. A medicament according to claim 14, wherein the delivery product, wherein said first and said second through holes of the first and second protrusions extending further inhibit rotational movement of the housing relative to the body.
17. 根据权利要求12所述的药物输送产品,其中所述第一和第二容器通过转移套装组件来接触,所述转移套装组件包括能够由用户接触的端口,所述主体包括被定位和布置用以接合所述端口的井状部,或包括塞住所述端口的塞子,从而抑制所述外壳的轴向运动。 17. A medicament according to claim 12, wherein the delivery product, wherein said first and second transfer container through the contact assembly kit, the assembly kit comprising a transfer port can be contacted by the user, the body and comprising a positioning arrangement to engage the well portion of the port, or ports comprising stoppered, thereby inhibiting axial movement of the housing.
18. 根据权利要求11所述的药物输送产品,其中所述药物重组组件通过所述至少一个突起的接合也抑制所述外壳相对于所述主体的旋转移动。 18. A medicament according to claim 11, wherein the product conveyor, wherein the medicament is suppressed recombinant assembly of the housing with respect to rotational movement of said body by engaging said at least one protrusion.
19. 根据权利要求11所述的药物输送产品,其中所述药物重组组件通过所述至少一个突起的接合也抑制所述外壳相对于所述主体的轴向移动。 19. A medicament according to claim 11, wherein the product conveyor, wherein the medicament is suppressed recombinant assembly relative to the axial direction of the housing main body by engaging movement of the at least one protrusion.
20. —种包装药物重组组件的方法,包括: 提供具有可移除盖子和主体的包装,所述主体被构造用以容纳所述药物重组组件,所述包装包括从所述主体延伸的至少一个突起; 提供所述药物重组组件,使所述药物重组组件具有包括至少一个孔的外壳,和被至少部分地放置在所述外壳内的容器,其中所述容器的颈部部分与所述外壳的所述孔中的至少一个孔对准; 将所述药物重组组件装配在所述包装的所述主体内,以便所述主体的所述至少一个突起穿过所述外壳的至少一个所述孔延伸,其中所述药物重组组件在所述包装内的定向被限制于预定数量的定向;和利用所述可移除盖子,将所述药物重组组件密封在所述包装的所述主体内。 20. - kind of pharmaceutical packaging recombinant assembly, comprising: providing a package having a removable lid and body, the body is configured to receive the assembly of recombinant medicament, the package comprising a body extending from the at least one protrusions; recombinant assembly providing the medicament, the medicament comprising a recombinant assembly having a housing at least one aperture, and is disposed at least partially within the container housing, wherein the container neck portion of the housing at least one aperture aligned with the bore; the drug of the recombinant assembly fitted within the body of the package, so that the at least one projection of said body of said housing through said at least one aperture extending wherein said medicament directed recombination within the package assembly is limited to a predetermined number of orientations; and using the removable lid, the drug recombinant assembly sealed within the body of the package.
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