CN103930142B - 注射器和装配方法 - Google Patents
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Abstract
本发明公开了注射器(100)，可包括具有壁(110)和密封组件(140)的容器(102)，所述壁(110)具有内表面(112)，所述密封组件(140)具有内表面(142)，所述壁(110)和所述密封组件(140)的内表面(110)限定填充药物产品的闭合的无菌储库(150)。注射器(100)还可包括流体递送系统，所述流体递送系统包括洁净的、无护套的刚性容器针(180)，所述刚性容器针(180)具有这样的尖(182)，所述尖(182)被设置成在存储状态中仅部分穿过密封组件(140)，并且被设置成在递送状态中穿过密封组件(140)的内表面(142)进入无菌储库(150)内。此外，注射可包括致动器(106)，所述致动器(106)适于将容器针从存储状态移动到递送状态。
Description
背景技术
本专利涉及注射器和装配注射器的方法，并且特别涉及预填充注射器和装配预填充注射器的方法。
注射器用于将医学流体例如液体药物递送给患者。特别地，注射器将通过针、插管或导管将流体提供给患者，所述针、插管或导管限定进入患者内的流动路径。某些注射器具有已连接到流动路径的由制造商装配的储库。然而，这些储库一般由制造商空的提供给患者或医疗保健提供者(例如医生、护士、医疗保健助理等)，并且随后储库在使用时进行填充。作为另外一种选择，注射器可与预填充提供给患者或医疗保健提供者的储库组合使用。
在任一情况下，注射器均必须在使用前进行制备。例如，如果储库空的提供，则储库必须被填充。为了实现这点，使注射筒填充待递送的药物，并且随后将药物通过入口端口注射到储库内。在注射前，例如，入口端口必须通过用酒精湿巾擦拭外表面进行灭菌。类似地，在预填充储库连接到替代注射器中的流动路径前，匹配连接器必须通过用酒精湿巾擦拭表面进行灭菌。
在任一情况下，注射器的使用均要求另外的材料和时间。
如下文更详细地描述的，本公开内容阐述体现上文讨论的常规装置和方法的有利替代物的改良注射器。
发明内容
根据本公开内容的一个方面，注射器可包括具有壁和密封组件的容器，所述壁具有内表面，所述密封组件具有内表面，所述壁和所述密封组件的内表面限定填充药物产品的闭合的无菌储库。注射器还可包括流体递送系统，所述流体递送系统包括洁净的、无护套的刚性容器针，所述刚性容器针具有这样的尖，所述尖被设置成在存储状态中仅部分穿过密封组件，并且被设置成在递送状态中穿过密封组件的内表面进入无菌储库内。此外，注射可包括致动器，所述致动器适于将容器针从存储状态移动到递送状态。
容器的壁可以是刚性壁或柔性壁。
根据前述的任何，密封组件可以是具有内表面的柔性整体壁，所述柔性整体壁限定密封组件的内表面。柔性整体壁可限定被设置成跨越开口且固定地附接到容器的壁的隔膜。作为另外一种选择，容器的壁可限定孔，并且整体柔性壁可限定可沿孔移动的阻挡件。在此类情况下，容器的壁可限定相对阻挡件的闭合端部和阻挡件被设置在其中的开放端部。作为进一步的替代方案，容器的壁可限定具有开口的孔，所述开口与孔的第一端部流体连通，并且整体柔性壁限定被设置成跨越开口且固定地附接到容器的壁的隔膜，该容器还包括阻挡件，所述阻挡件被设置在孔的第二端部内并可沿孔移动。
在前述段落的替代方案中，密封组件可包括具有内表面的柔性壁，所述柔性壁限定密封组件的内表面，且包括被设置在柔性壁外部的洁净屏障，以限定在柔性壁和洁净屏障之间的封闭的洁净空间，容器针的尖被设置成在存储状态中穿过洁净屏障进入洁净空间内。容器的壁可限定孔，并且柔性壁和洁净屏障可各自限定可沿孔移动的阻挡件。此外，容器可包括与在洁净屏障和柔性壁之间的空间流体连通的通风孔，所述通风孔可在洁净屏障中或在容器的壁的内表面内形成。此外，容器的壁可限定相对阻挡件的闭合端部和阻挡件被设置在其中的开放端部。在替代方案中，容器的壁可限定具有开口的孔，所述开口与孔的第一端部流体连通，并且柔性壁和洁净屏障各自可限定被设置成跨越开口的隔膜，该容器还包括阻挡件，所述阻挡件被设置在孔的第二端部内并可沿孔移动。
根据前述中的任何，流体递送系统可包括洁净的柔性管道，所述洁净的柔性管道在第一端部处连接到刚性容器针，并且在第二端部处连接到容纳在洁净罩内的洁净的刚性注射针，所述洁净罩隔离洁净的刚性注射针。
根据前述中的任何，致动器可适于在存储状态和递送状态之间反复移动容器针。
根据前述中的任何，致动器可适于在接受输入后延迟容器针从存储状态到递送状态的移动。
根据前述中的任何，注射器可包括联接到致动器的机械、机电或电输入装置。
根据前述中的任何，药物产品可包括一定体积的下述物质：红细胞生成刺激剂、粒细胞集落刺激因子、TNF阻滞剂、聚乙二醇化粒细胞集落刺激因子、白细胞介素受体特异性抗体、IGF受体(胰岛素生长因子受体)特异性抗体、TGF特异性抗体、或PCSK9(前蛋白转化酶枯草杆菌蛋白酶/Kexin9型)特异性抗体。
根据本公开内容的另一个方面，装配注射器的方法可包括在无菌条件下用药物产品填充容器的无菌储库，所述储库由容器的壁的内表面和密封组件的内表面限定。该方法还可包括在填充无菌储库后，在洁净室条件下插入洁净的、无护套的刚性容器针的尖部分穿过密封组件，以限定存储状态，并且在洁净室条件下将容器针附接到致动器，该致动器适于将容器针从存储状态移动到递送状态，其中容器针被设置成穿过密封组件的内表面进入无菌储库内。
根据这个方面，容器的壁可以是刚性壁或柔性壁。
附图说明
认为公开内容根据与附图结合考虑的下述说明书将得到更全面理解。附图中的一些可通过省略所选元件进行简化，以用于更明确显示其他元件的目的。在一些附图中的此类元件省略不一定指示特定元件在示例性实施例中任一中的存在或不存在，除了在相应书面说明书中可明确描述的外。附图无一必须按比例绘制。
图1是根据本公开内容的注射器的实施例的横截面视图，其中无护套的刚性容器针处于存储状态，其中针部分穿入容器的整体壁；
图2是与图1的注射器容器一起使用的夹具的透视图，以控制容器的柔性整体壁被容器针的穿入；
图3是图1的注射器的横截面视图，其中容器针处于递送状态，其中针穿入容器的整体壁，使得它被设置成穿过柔性壁的内表面进入无菌储库内；
图4是根据本公开内容的注射器可在其中填充且装配的制造设施的简图；
图5是根据本公开内容的注射器的替代实施例的横截面视图，其中无护套的刚性容器针处于存储状态，其中针部分穿入容器的整体壁；
图6是根据本公开内容的注射器的进一步替代实施例的横截面视图，其中无护套的刚性容器针处于存储状态，其中针部分穿入容器的整体壁；
图7是根据本公开内容的注射器的实施例的横截面视图，其中刚性容器针处于存储状态，其中针部分穿入密封组件的洁净屏障，而不是柔性壁；
图8是根据本公开内容的注射器的替代实施例的横截面视图，其中刚性容器针处于存储状态，其中针部分穿入密封组件的洁净屏障，而不是柔性壁；
图9是图8的实施例的变体的横截面视图，所述变体包括通风孔，以当相关容器针在存储状态和递送状态之间移动时，排空在柔性壁和外部设置的洁净屏障之间的洁净空间；
图10是图8的实施例的另外变体的横截面视图，所述变体包括旁路，以当相关容器针在存储状态和递送状态之间移动时，排空在柔性壁和外部设置的洁净屏障之间的洁净空间；
图11是处于中间状态的图10的容器的横截面视图，其中旁路与在柔性壁和洁净屏障之间限定的洁净空间流体连通；
图12是容器和流体递送系统的进一步装配的示意图，所述进一步装配可用于保持容器内的无菌状况；
图13是根据本公开内容的再进一步实施例的注射器的横截面视图，其中在储库中维持无菌状况直到流体递送系统致动时；
图14是图13中示出的注射器的变体的横截面视图；
图15是图13中示出的注射器的进一步变体的横截面视图；和
图16是示出装配根据本公开内容的注射器的方法的流程图。
具体实施方式
尽管下述正文阐述本发明的不同实施例的详细描述，但应当理解本发明的法律范围由在本专利结束时所述的权利要求的用词限定。还应当理解，除非术语在本专利中使用句子“如本文所用，术语‘_____’在此定义为意指”或类似句子明确限定，否则不预期明确或暗示限制该术语的含义超过其平常或普通含义，并且此类术语不应解释为限制于基于在本专利的任何部分中作出的任何陈述(除权利要求的语言外)的范围。到在本专利结束时的权利要求中所述的任何术语在本专利中以与单一含义一致的方式提及的程度，这仅为清楚起见而完成，以便不使读者混乱，并且不预期此类权利要求术语通过暗示或其他方式限制于该单一含义。最后，除非权利要求元件通过叙述单词“意指”和没有任何结构叙述的功能限定，否则不预期任何权利要求元件的范围基于35U.S.C.§112第六段的应用加以解释。
详细描述应解释为仅是示例性的，并且不描述本发明的每一个可能实施例，因为描述每一个可能实施例即使不是不可能的，也将是不实际的。众多替代实施例可使用目前技术或在本专利的提交日期后开发的技术(其仍落入限定本发明的权利要求范围内)实现。随后沿着这些思路，根据本公开内容的几个实施例在图1-3和5-15中示出。
在一般术语中，根据本公开内容的注射器包括容器、流体递送系统和致动器。虽然对注射器作出提及，所述注射器在一些情况下可指的是确保递送设定体积的药物产品的递送装置，但应当理解本公开内容还涵盖输注装置，所述输液装置在一些情况下可指的是确保实现特定递送速率的递送装置。还应当理解在提及说明书中的实施例时，术语注射器和输注器可互换使用。
如图1-3和5-15所示，容器可包括具有内表面的壁和具有内表面的密封组件，所述壁和所述密封组件的内表面限定填充药物产品的闭合的无菌储库。此外，在这些实施例中示出的流体递送系统可包括洁净的、无护套的刚性容器针，所述刚性容器针具有这样的尖，所述尖被设置成在存储状态中仅部分穿过密封组件，并且被设置成在递送状态中穿过密封组件的内表面进入无菌储库内。注射器还可包括致动器，所述致动器适于将容器针从存储状态移动到递送状态，如下文更详细地讨论的，这可涉及针相对于容器的移动或容器相对于针的移动。
如图1、3和4-6所示，密封组件可以是具有内表面的柔性整体壁，所述柔性整体壁限定密封组件的内表面，并且容器针的尖可被设置成部分进入整体壁内。作为另外一种选择，如图7-11所示，密封组件可包括具有内表面的柔性壁，所述柔性壁限定密封组件的内表面，且包括被设置在柔性壁外部的洁净屏障，以限定在柔性壁和洁净屏障之间的封闭的洁净空间。根据此类实施例，容器针的尖被设置成在存储状态中穿过洁净屏障进入洁净空间内。
再进一步的替代方案在本文示出的实施例各自的背景下进行讨论。
随后参考图1，在其中示出了注射器100。注射器100包括容器102、流体递送系统104和致动器106。
容器102(其在本文中还可被称为药筒)包括壁110，所述壁110具有内表面112和外表面114。虽然在图1中已示出限定内表面和外表面112、114两者的整体(即单片)壁110，但应当理解根据其他实施例，壁110可包括多个层，其中不同层限定内表面和外表面112、114。
根据本公开内容的某些实施例，壁110是刚性的。根据其他实施例，壁110可以是柔性的，无论是根据限定壁的材料的性质还是根据壁的结构(例如风箱(bellow)构造)的性质。壁110可由例如玻璃、金属或聚合物制成。特别地，聚合物形式可由例如聚碳酸酯、聚丙烯、聚乙烯(例如高密度聚乙烯)、聚四氟乙烯、环状烯烃聚合物、环状烯烃共聚物、晶体Zenith烯烃聚合物(可得自Daikyo Seiko，Ltd.，日本)、尼龙或工程树脂制成。关于柔性形式的壁110，可使用丁基橡胶、硅基橡胶、乳胶基橡胶、涂覆橡胶以及多层聚合物薄膜，例如可包括聚乙烯(例如低密度聚乙烯)和聚丙烯。
壁110可具有一般为圆柱形的形状，肩部120使具有第一横截面直径的第一圆柱形区段122与具有第二横截面直径的第二圆柱形区段124分开，所述第一横截面直径小于所述第二横截面直径。壁110还可限定两个相对的开放端部126、128。壁110或更具体地壁110的内表面112还可限定孔130。
容器102可包括柔性整体壁140(其还可被称为密封件或隔膜)，所述柔性整体壁140具有内表面142和外表面144。整体壁140可被设置在由壁110限定的第一开放端部126中，并且固定地附接到容器102的壁110，使得在壁140和壁110之间，例如在跨越开放端部或开口126的壁140与壁110的附接点处存在有限的相对移动。此外，壁110和柔性壁140的内表面112、142可至少部分限定闭合的无菌储库150，所述闭合的无菌储库150填充下文更详细地描述的药物产品160。壁140可由例如溴化丁基橡胶、氯化丁基橡胶或氯化溴化丁基橡胶(chlorobromobutyl rubber)、氟聚合物橡胶、天然橡胶、硅基橡胶、硅或山都平橡胶(santoprene)制成。
容器102还可包括具有内表面和外表面172、174的阻挡件或活塞170。活塞170可容纳在由壁110限定的端部128内，并且可在容器102的端部126、128之间沿孔130移动。根据此类实施例，药物产品160被设置在其内的储库150可由壁110、140和活塞170的内表面112、142、172限定。
容器102可与流体递送系统104结合使用，所述流体递送系统104的有关部分在图1中示出。特别地，流体递送系统104可包括具有尖182的洁净的、无护套的刚性容器针180。如所示的，尖182被设置成在存储状态中仅部分进入柔性壁140内。针180的尖182进入壁140内的穿入可通过许多方法和/或机构进行控制。例如，图2示出了可与容器102组合使用的夹具，以控制尖182穿入壁140的深度。
流体递送系统104还可包括具有尖192的注射针190。注射针190的尖192可由针护罩194覆盖，以防止与尖192的接触和尖192的污染。容器针180和注射针190可由插管或管200连接，根据本公开内容的某些实施例，所述插管或管200可以是柔性插管。针190如同针180可由例如不锈钢制成。
流体递送系统104可与致动器106结合使用，所述致动器106先前提及且在图1中示意性示出。致动器106可适于使容器针180在图1所示的存储状态和图3所示的递送状态之间移动。在递送状态中，容器针180被设置成穿过柔性壁140的内表面142进入无菌储库150内。
针180在状态之间的移动可以多种方式发生。例如，针180可相对于注射器100的壳体保持固定，并且容器102可相对于针180和壳体移动。作为另外一种选择，容器102可相对于壳体保持固定，并且针180可相对于容器102和壳体移动。容器102和针180两者均相对于注射器100的壳体移动也是可能的。应当理解所有这些动作均可包含在下述陈述内：致动器106适于在存储和递送状态之间移动容器针180。
致动器106可以是机械、机电或电的。例如，致动器106可包括螺线管、马达驱动杠杆、具有相关传动装置的马达等。甚至还能够提供附接到容器102或针180的凸片或按钮，以允许使用者手动实现在容器102和针180之间的相对运动。事实上，容器102可容纳在凸片或按钮内，当注射器100被致动以相对于(固定)针180移动容器102时，所述凸片或按钮被压入壳体内。
通过将针180从存储状态移动到递送状态，或通过将针180从递送状态移动到存储状态，致动器106可在存储和递送状态之间移动容器针180。事实上，致动器可在存储和递送状态之间反复(即多次或重复)移动容器针180。此外，致动器106可在接受输入或信号(例如，如通过联接到致动器106的按钮、开关或其他输入装置的压下或操作生成的，所述按钮、开关或其他输入装置在性质中可以是机械、机电或电的)后立即移动容器针180，或可在接受输入后一段时间延迟容器针180在存储和递送状态之间的移动。根据特定实施例，致动器106可延迟针180从存储状态到递送状态的移动，直到此类时间延迟后。
如先前提及的，储库150描述为无菌的，而容器针180描述为洁净的。这些术语描述储库150或针180由于其在这样的条件下装配的状况，所述条件将确保指定的无污染水平，其中无菌物体或装置应理解为具有比洁净物体或装置相对更高的无污染水平。作为非限制性例子，无菌和洁净度的概念可参考图4的简图进行讨论，所述讨论将认识到不仅应用于图1和3所示的实施例，还应用于本文描述的所有实施例。
图4示出了制造设施250，并且可用于讨论在设施250内进行的制造过程。应当指出设施250区分成多个空间252、254、256、258、260、262、264、266、268，所述区分可通过使用永久或半永久性壁或其他屏障得到维持。如应当理解的，某些空间或区域可无需屏障或壁进行区分，相反可只在组构水平上分开。另外，将认识到可使用更大或更少数目的空间或空间的替代布置，此类空间的不同数目或布置可容易地由本领域普通技术人员决定。
容器102的部件(壁110、140和阻挡件/活塞170)将通过空间252进入设施250，其中部件使用例如电子束技术进行灭菌。作为另外一种选择，当部件在入口点252、264、266处进入设施250时，容器部件可通过其他目前已知的(例如用二氧化氯或蒸汽相过氧化氢处理)或以后开发的灭菌操作进行灭菌。容器102随后将进入空间254内用于由药物产品填充。空间254可作为消毒100级洁净室操作。100级洁净室是其中每立方英尺空气允许的0.5μm或更大尺寸的颗粒数目小于100的洁净室。一旦已执行填充，并且阻挡件170已设置于容器102的端部128中，在容纳到存储空间258内之前，容器102和药物产品160就移动通过转移空间256(同样作为100级洁净室操作，其中某些实施例也是消毒的)。
容器102从存储空间258移动到检查区260(在某些实施例中是消毒的)内，其中容器102在与流体递送系统104、致动器106和注射器100的其他元件装配前进行检查。因为药物产品160在这个点时包含在密封容器102内，所以检查区可作为10,000级洁净室操作。一旦已检查，预填充的无菌容器102就从检查空间260传递到装配空间262。
类似于检查空间260，装配空间262可作为消毒10,000级洁净室操作。被从空间264、266传送到洁净室内的材料可处于无菌状况，或可使用例如电子束技术进行灭菌。在装配空间262内，一旦壁/隔膜140的表面144已通过用酒精湿巾擦拭表面144进行灭菌，流体递送系统104就连接到容器102。因为更低的洁净度水平，流体递送系统104可被称为洁净的，但不一定是无菌的。然而，因为容器针180不穿入通过壁140，所以储库150和药物产品160保持无菌(即，处于更高洁净度水平)。在注射器100进入包装空间268内之前，注射器100的剩余部分还可在这个空间262中装配，其中在容器102和流体递送系统104装配前，注射器的某些方面(例如致动器106)有可能与容器102或流体递送系统104装配。
将认识到图1和3所示的注射器100的实施例仅是根据本公开内容的示例性实施例。为此，图5和6示出了图1和3所示的注射器的变体。
根据图5的实施例，注射器300包括容器302、流体递送装置304和致动器306。类似于图1和3的实施例，容器302包括具有内表面和外表面312、314的壁310。此外，壁310可具有两个相对端部320、322，其中壁310的内表面312限定在相对端部320、322之间的孔324。
然而，与容器102不同，容器302具有关闭端部320的固定塞326。此外，虽然容器203具有柔性整体壁330，所述柔性整体壁330具有内表面和外表面332、334，所述壁330被设置在容器302的端部322内，并且因此执行在容器102中的阻挡件/活塞170的作用。因此，壁330可在相对端部320、322之间沿孔324移动。此外，壁310、330的内表面312、332限定药物产品350被设置在其中的无菌储库340。
根据这个实施例，流体递送装置304可包括具有尖362的洁净的、无护套的刚性容器针360。针360的尖362，如同针180的尖182，被设置成在存储状态中仅部分进入柔性壁330内，其中致动器306促使尖362在存储状态和递送状态之间移动，在所述递送状态中，尖362被设置成穿过柔性壁330的内表面332进入无菌储库340内。容器针360可与穿过例如容纳在活塞杆382内的插管380的注射针370流体连通，所述注射针370具有由护罩374覆盖的尖372，所述杆382可用于在容器302的端部320、322之间移动阻挡件/活塞330。
图6显示图5所示变体的紧密相关变体。根据图6所示变体，容器具有壁390，所述壁390具有内表面和外表面392、394。然而，与先前讨论的容器不同，壁390限定闭合端部396和开放端部398。容器还包括柔性壁400，如同图5的实施例的壁330，所述壁400可在开放端部398和闭合端部396之间在容器内移动。根据这个实施例，不需要单独的结构以关闭端部396、398之一，因为壁390自身已限定闭合端部396。就此而言，闭合端部396可调整大小，使得它径向大于图6所示。
因此已讨论其中密封组件仅包括柔性整体壁的多个实施例，进一步的多个实施例将参考其中密封组件包括多个壁和/或密封件的图7-11进行讨论。这个结构还可被称为区室化密封件(或参考图7的隔膜，或参考图8-11的阻挡件)。
首先参考图7，注射器450包括容器452、流体递送系统454和致动器456。
容器452包括壁460，所述壁460具有内表面462和外表面464。如同图1和2的容器，壁460可具有一般为圆柱形的形状，其中肩部470使具有第一横截面直径的第一圆柱形区段472与具有第二横截面直径的第二圆柱形区段474分开，所述第一横截面直径小于所述第二横截面直径。壁460还可限定两个相对的开放端部476、478。壁460或更具体地壁460的内表面462还可限定孔480。
与图1和3的容器102不同，图7的容器452具有包括超过单个整体壁的密封组件。容器452的密封组件包括柔性壁490和洁净屏障492。柔性壁490具有内表面494和外表面496，而洁净屏障492具有内表面498和外表面500。壁460和柔性壁490的内表面462、494限定填充药物产品520的闭合的无菌储库510。另一方面，洁净屏障492被设置在柔性壁490的外部，以限定在柔性壁490和洁净屏障492之间的封闭的洁净空间530。洁净空间530可由壁460的内表面462、柔性壁490的外表面496和洁净屏障492的内表面498限定。
如所示的，容器252还可包括具有内表面和外表面542、544的阻挡件或活塞540。活塞540可容纳在由壁460限定的端部478内，并且可在容器450的端部476、478之间沿孔480移动。根据此类实施例，药物产品520被设置在其内的储库510可由壁460、490和活塞540的内表面462、494、542限定。
图7的实施例还包括流体递送系统454，所述流体递送系统454包括洁净的、无护套的刚性容器针550，所述刚性容器针550具有尖552，所述尖552被设置成在存储状态中穿过洁净屏障492进入洁净空间530内，并且被设置成在递送状态中穿过柔性壁490的内表面494进入无菌储库510内。在这个意义上，容器针550仅部分穿入密封组件。流体递送系统454还可包括具有尖562的注射针560，所述尖562至少最初由针护罩564覆盖，以防止与尖562的接触和尖562的污染。容器针550和注射针560可由插管或管570连接，根据本公开内容的某些实施例，所述插管或管570可以是柔性插管。
与图1和3的实施例的情况一样，本公开内容包括图7所示实施例的多个变体，所述变体在图8-11中示出。
图8的实施例类似于图7的实施例，其方式与图5的实施例类似于图1和3的实施例一样。特别地，根据图8的实施例的注射器600的密封组件被设置在容器602中，代替相对于容器452示出的阻挡件/活塞540。即，容器602包括限定孔606的壁604、以及各自限定阻挡件的柔性壁608和洁净屏障610，所述阻挡件可沿孔606移动。虽然容器602的壁604不限定所示实施例中的相对开放和闭合端部，但此类替代方案根据类似于图6的本公开内容是可能的。
图9-11示出了图8所示实施例的变体，所述变体包括另外的特征，以允许在柔性壁和洁净屏障之间的空间或区域被排空或排出。这些另外的特征可被称为通风孔、阀或旁路，但当致动器将相关容器针从存储状态移动到递送状态时，这些结构的全部均允许气体自柔性壁和洁净屏障之间的空间或区域逃出。这并非暗示内壁和外部屏障不能根据本公开内容的其他实施例，例如通过使用一个或多个间隔物而保持分离。然而，图9-11的替代方案示出了关于其中内壁和外部屏障结合在一起的那些实施例，用于排空洁净空间的选项。
在图9中示出了包括壁652和密封组件的容器650，该组件包括柔性壁654和洁净屏障656。柔性壁654具有内表面658和外表面660，而洁净屏障654具有内表面662和外表面664。壁652的内表面668和柔性壁654的内表面658限定填充药物产品680的闭合的无菌储库670。另一方面，洁净屏障656被设置在柔性壁654的外部，以限定在柔性壁654和洁净屏障656之间的封闭的洁净空间690。洁净空间690可由壁652的内表面668、柔性壁652的外表面660和洁净屏障656的内表面662限定。
另外如图10所示，包括容器针702的流体递送系统700与密封组件结合使用。容器针702以存储状态示出，其中容器针702被设置成穿过洁净屏障656，使得针702的尖704被设置在洁净空间690中。尖704在未示出的递送状态中将穿入柔性壁654且深入(depend into)储库670内。将认识到针702特别是关于其长度未按比例绘制，此处示出的其他实施例也一样。
与先前讨论的实施例相比较，图9所示的容器650包括至少一个通风孔710。通风孔710与在洁净屏障656和柔性壁654之间的洁净空间690流体连通。当密封组件在示出的存储状态和递送状态之间移动时，其中洁净屏障656在柔性壁654的方向推进，以允许容器针702的尖704穿入通过壁654，通风孔710选择性致动，以允许截留在洁净屏障656和柔性壁654之间的气体通过通风孔710逃出。然而，通风孔710可相对于环境处于密封状况，直到例如通过洁净空间690内的压力变化致动时。
如所示的，通风孔710被设置在洁净屏障656内，并且在屏障656的内表面662和外表面664之间延伸。挡板712覆盖接近于外表面664的通风孔710的端部，并且由此密封通风孔710的端部直到通风孔被致动时，从而保持在洁净屏障656和柔性壁654之间的空间690的洁净度。作为另外一种选择，通风孔710可例如被布置在容器650的壁652中。
图10和11示出了关于图8的系统的进一步变体，其中容器720包括壁722和密封组件，该组件包括柔性壁724和洁净屏障726。柔性壁724具有内表面728和外表面730，而洁净屏障726具有内表面732和外表面734。壁722的内表面738和柔性壁724的内表面728限定填充药物产品750的闭合无菌储库740。另一方面，洁净屏障726被设置在柔性壁724的外部，以限定在柔性壁724和洁净屏障726之间的封闭的洁净空间760。洁净空间760可由壁722的内表面738、柔性壁722的外表面730和洁净屏障726的内表面732限定。
另外如图10所示，包括容器针772的流体递送系统770与密封组件结合使用。容器针772以存储状态示出，其中容器针772被设置成穿过洁净屏障726，使得针772的尖774被设置在洁净空间760中。尖774在未示出的递送状态中将穿入柔性壁724且深入储库740内。
与先前讨论的实施例相比较，图10所示的容器720包括至少一个旁路或通风孔780。旁路780与储库740流体连通。当密封组件在示出的存储状态和递送状态之间移动时，其中洁净屏障726在柔性壁724的方向推进，以允许容器针772的尖774穿入通过壁724，旁路780选择性致动，以允许截留在洁净屏障726和柔性壁724之间的气体通过旁路780逃出到储库740内。
然而，旁路780不与洁净空间760流体连通，直到柔性壁724已从图10所示的存储状态移动到图11所示的中间状态。如图10和11所示，旁路780可限定在壁722的内表面738中，并且如所示的可采取在壁722中形成的凹槽782的形式。凹槽782可具有远端784和近端786。如将认识到的，直到柔性壁724的外表面730移动经过凹槽782的远端784时，储库740相对于洁净空间760处于密封状况。然而，一旦柔性壁724的外表面730移动经过凹槽782的远端784，截留在洁净屏障726和柔性壁724之间的气体就可排出到储库740内。这可有利于屏障726和针770朝向柔性壁724的移动。
虽然前述实施例全部均不同程度地集中于被设置成部分穿过密封组件的流体递送系统，但存在其中容器针未被设置成穿过密封组件或其中容器针被设置成完全穿过密封组件的其他替代方案。三个此类替代方案在图12-14中示出。
图12示出了注射器800，所述注射器800具有容器802、流体递送系统804和致动器806。类似于上文示出的实施例，致动器806将促使流体递送系统804被设置成在递送状态中穿过与容器802相关的密封组件，并且由此与容器802的内部流体连通。然而，如上所述，在图12所示的存储状态中，流体递送系统甚至没有被设置成部分穿过密封组件。
为此，容器802包括至少柔性壁810，所述柔性壁810可为根据本公开内容的隔膜或阻挡件的形式。柔性壁810具有内表面812和外表面814。另外，流体递送系统804包括容器针816、注射针818、以及连接容器针816和注射针818的柔性导管820。容器针816和注射针818两者均容纳在罩822、824内，所述罩822、824保持针816、818的洁净度。罩822可被称为帽，而罩824可被称为护罩。还包括的是被设置在柔性壁810和罩822之间的酒精湿巾826，所述湿巾826可保持气密状况以维持酒精饱和。
根据本公开内容，在起始致动器806的动作前，将湿巾826从柔性壁810和罩822之间抽出。例如，湿巾826的端部可被设置在注射器800的壳体外部，以允许端部被抓握，并且湿巾826从注射器800中拉出。作为另外一种选择，湿巾826的端部可附接到注射器800将被附接到患者的另一面，例如覆盖注射器800的粘附表面的衬垫，使得当衬垫被取出以暴露粘附表面时，湿巾826同样从注射器800中拉出。湿巾的取出灭菌壁810的表面814和帽822的相对表面828。致动器806随后移动容器针816穿过帽822和柔性壁810。
另一方面，图13和14示出了其中容器针被设置成穿过柔性壁(限定阻挡件或隔膜)，并且阀用于使储库密封与注射针隔开的实施例。阀还可用于控制药物产品来自容器中的储库的流动。以这种方式，阀可用于计量来自储库的药物产品量，或延迟药物产品的流动，直到相对于例如从输入装置(例如按钮或开关)接受输入的时间延迟已过去。
像这样，图13示出了注射器850，所述注射器850具有容器852、流体递送系统854和致动器856。容器852包括至少柔性壁860，所述柔性壁860可为根据所示出实施例的隔膜的形式。柔性壁860具有内表面862和外表面864。另外，流体递送系统854包括容器针866、注射针868以及连接容器针866和注射针868的柔性插管或管道870。注射针868可容纳在罩872内，所述罩872保持针868的洁净度。
另一方面，容器针866(且特别是容器针866的尖874)被设置成穿过柔性壁860穿过内表面862。针866因此与无菌储库880和被设置在储库880内的药物产品890流体连通。在容器针866和注射针868之间的流体连通由阀900中断，所述阀900被设置在柔性管道870中或沿柔性管道870设置，所述阀900可限定在注射器850的无菌部分和注射器850的洁净部分之间的边界。因此，与上文关于图1-12讨论的其他实施例不同，注射器850的致动器856不用于相对于柔性壁860移动容器针866，而是在闭合状态和开放状态之间操作阀，在所述闭合状态中，流体连通在针866、868之间中断，在所述开放状态中，容器针866与注射针868流体连通。
将认识到阀900可采取多种形状和形式，其中两种在图13和14中示出。特别地，图13示出了注射器850的实施例，其中可旋转阀900被设置在柔性管道870中，或具有与流体流动路径流体连通的内部阀构件，所述流体流动路径限定在容器针866和注射针868之间。相比之下，图14示出了注射器的实施例，其中夹管阀902沿柔性管道870设置，并且因此与管道870的外表面协作，以中断在容器针866和注射针868之间的流体连通。
例如图13和14所示的实施例还将与具有永久附接的针的容器一起良好工作，使得容器为例如注射筒的形式。
还将理解图13和14中示出的实施例还可修饰为掺入密封组件，所述密封组件包括多个壁和/或密封件，例如如图7中所示。图15示出了此类实施例。
特别地，图15示出了注射器920，所述注射器920具有容器922、流体递送系统924、致动器926和密封组件928。流体递送系统924可包括容器针930、注射针932、以及连接容器针930和注射针932的柔性插管或管道934。注射针932可容纳在罩936内，所述罩936保持针932的洁净度。针932还可经由被设置在柔性管道934中或沿柔性管道934设置的阀944，与无菌储库940和被设置在储库940内的药物产品942选择性流体连通。在这点上，注射器920类似于图13和14中所示的那些。
然而，注射器920的密封组件928还具有柔性壁950和洁净屏障952。柔性壁950和洁净屏障952各自具有内表面和外表面，其中柔性壁950的内表面部分地限定闭合的无菌储库940。另一方面，洁净屏障952被设置在柔性壁950的外部，以限定在柔性壁950和洁净屏障952之间的封闭的洁净空间954，容器针930的尖956可被设置在所述洁净空间954中。
在这点上，图15的实施例具有两个可能屏障：为阀944形式的一个和以尖956放置在洁净空间954内的形式的第二个。事实上，在已促使容器针930穿入通过柔性壁950进入储库940内之后，可控制阀944，以提供药物产品942注射的延迟。
如将认识到的，根据本公开内容的装置可具有相对于常规技术的一个或多个优点，所述优点中的任何一个或多个可依照包括在特定实施例中的本公开内容的特征存在于该实施例中。作为一个例子，这些实施例维持药物产品的无菌直到使用时。作为另一个例子，关于混合药物产品的可能性在使用时间之前是受限制的或被消除的。作为再进一步的例子，药物产品的非故意递送在使用时间之前是受限制的或被消除的。
仅为了举例说明性目的，图16提供了用于装配根据上文公开的实施例中任一个的递送装置的进一步方法1000。该方法1000遵循上文关于图4概述的一般处理流程。然而，不是参考根据美国联邦标准209E的洁净室分类，而是参考根据GMP EU标准的洁净室分类。此外，方法1000提供了可在递送装置的装配中遵循的另外任选路径(表示为左或右分支)。因此，图16的方法1000可视为上文关于图4的讨论的补充。
用于装配递送装置的方法1000在方框1002处开始。在该装置中使用的容器最初存储于密封桶中。如上所述，这些容器在一些点时可以被灭菌或可以是已经灭菌的。在方框1002处，桶在C级洁净室中例如使用自动化除袋机进行除袋。在方框1004处，例如在作为A级洁净室操作的空间中，可能在其他方面作为C级洁净室操作的空间中的隔离器内，剥掉(例如由机械人)且去除Tyvek密封条。
将容器填充且附接阻挡件，并且随后在方框1006处，在作为A级洁净室的空间中，可能在其他方面作为C级洁净室操作的空间中的隔离器内，容器在开放桶中再嵌套(re-nested)。从这个点开始，两个不同的替代路径或分支是可能的。
填充的容器可在方框1008处留在开放桶中。桶可被输送且被车装载到在方框1010处的存储空间(例如冷室)。
如果遵循方框1008、1010的路线，则该方法1000可继续，其中桶被传递到在方框1012处的检查室用于处理。填充的容器随后在方框1014处从开放桶中去嵌套(denested)，并且供应给在方框1016处的自动检查机。填充的容器的自动检查在方框1016处发生，随后为在方框1018处的任选的、另外的半自动化或手动检查。
作为另外一种选择，桶可在方框1020处再密封、再装袋且标记。例如，桶可在方框1020处在C级洁净室中用Tyvek(例如使用Bausch+Strobel桶密封器)再密封，再装袋且随后标记。桶随后可根据需要在方框1022、1024处存储，或甚至运送。
一旦存储或运输完成，桶就在方框1026处例如使用自动化除袋机进行除袋。在方框1028处，将Tyvek密封条剥掉且去除。填充的容器随后可在方框1030处去嵌套用于检查。在方框1026、1028、1030处的动作在C级洁净室中执行。随后可在方框1032处在C级洁净室中，使用设计用于操作的目视检查机器进行自动检查。
遵循任一程序，填充的、经检查的容器随后可传递到在方框1034处的回旋托盘(rondo tray)。
根据第一程序，回旋托盘可直接送往在方框1036处存储。如果遵循方框1036的路线，则回旋托盘被传递到在方框1038处的装置装配室进行处理。容器在方框1040处去嵌套，并且在方框1042处与递送装置的其他元件装配，以限定装配的递送装置(例如注射器或输注器)。
作为另外一种选择，容器可移动到桶内，所述桶在方框1044处密封、装袋且标记。例如，桶可在C级洁净室中用Tyvek再密封，装袋且随后标记。桶随后可根据需要在方框1046、1048处存储，或甚至运送用于进一步处理。一旦存储或运输完成，桶就在方框1050处例如使用自动化除袋机进行除袋。在方框1052处，将Tyvek密封条剥掉且去除，并且将容器去嵌套。填充的容器随后可在方框1054处与递送装置的其他元件装配。在方框1050、1052、1054处的动作均可在C级洁净室中发生。
在任一情况下，装配的装置均在方框1056处进行包装，并且随后将经包装、装配的装置存储在方框1058处。最后，将经包装、装配的装置运输到在方框1060处的分配器和/或用于其他分配动作。
本文未具体列出的其他优点同样也可认识到。此外，另外其他变体和替代方案是可能的。
例如，虽然致动器的操作已关于前述实施例描述为移动的，例如容器针从存储状态到递送状态，但应当理解致动器还可使容器针从递送状态移动到存储状态。例如，如果待递送的药物产品的剂量小于储库的体积(例如可以是这样的情况：其中注射器设计为按程序工作，以根据患者需要(例如儿科患者相对于成人患者)递送可调节剂量)，则致动器可在剂量递送前将容器针从存储状态移动到递送状态，并且在剂量递送后将容器针从递送状态移动到存储状态。从递送状态到存储状态的移动事实上将再密封容器且关闭对患者的流体路径。可重复在存储状态和递送状态之间的这个移动顺序。如上所述，维持关闭的流动路径直到递送起始时是有利的，因为关于药物产品对患者的非故意递送和/或药物产品与患者体液混合的机会减少。
根据本公开内容的注射器可与多种药物产品一起使用，所述药物产品包括集落刺激因子，例如粒细胞集落刺激因子(G-CSF)，可施用以增加在骨髓或外周血中发现的免疫细胞(例如白血细胞)数目。此类G-CSF试剂包括但不限于(非格司亭)和(聚乙二醇非格司亭)。
在其他实施例中，注射器可与多种其他产品一起使用，所述其他产品包括例如可为液体或冻干形式的红细胞生成刺激剂(ESA)。ESA是刺激红细胞生成的任何分子，例如(依泊汀α)、(达依泊汀α)、(依泊汀δ)、(甲氧基聚乙二醇-依泊汀β)、MRK-2578、INS-22、(依泊汀ζ)、(依泊汀β)、(依泊汀ζ)、(依泊汀α)、依泊汀α赫素、(依泊汀α)、(依泊汀θ)、(依泊汀θ)、(依泊汀θ)、依泊汀α、依泊汀β、依泊汀ζ、依泊汀θ、和依泊汀δ，以及如下述专利或专利申请中公开的分子或其变体或类似物，所述专利或专利申请各自以引用的方式整体并入本文：美国专利号4,703,008；5,441,868；5,547,933；5,618,698；5,621,080；5,756,349；5,767,078；5,773,569；5,955,422；5,986,047；6,583,272；7,084,245；和7,271,689；以及PCT公开号WO9I/05867；WO95/05465；WO96/40772；WO00/24893；WO01/81405；和WO2007/136752。
ESA可以是红细胞生成刺激蛋白质。如本文使用的，“红细胞生成刺激蛋白质”意指直接或间接促使促红细胞生成素受体的激活，例如通过与受体结合且促使受体二聚化的任何蛋白质。红细胞生成刺激蛋白质包括促红细胞生成素及其变体、类似物或衍生物，所述变体、类似物或衍生物与促红细胞生成素受体结合且激活促红细胞生成素受体；与促红细胞生成素受体结合且激活受体的抗体；或与促红细胞生成素受体结合且激活促红细胞生成素受体的肽。红细胞生成刺激蛋白质包括但不限于依泊汀α、依泊汀β、依泊汀δ、依泊汀ω、依泊汀ι、依泊汀ζ及其类似物，聚乙二醇化促红细胞生成素、氨甲酰化促红细胞生成素、模拟肽(包括EMP1/培尼沙肽(hematide))、和模拟抗体。示例性红细胞生成刺激蛋白质包括促红细胞生成素、达依泊汀、促红细胞生成素激动剂变体、以及结合且激活促红细胞生成素受体的肽或抗体(并且包括美国公开号2003/0215444和2006/0040858中报道的化合物，所述公开各自的公开内容以引用的方式整体并入本文)，以及如下述专利或专利申请(所述专利或专利申请各自以引用的方式整体并入本文)中公开的促红细胞生成素分子或其变体或类似物：美国专利号4,703,008；5,441,868；5,547,933；5,618,698；5,621,080；5,756,349；5,767,078；5,773,569；5,955,422；5,830,851；5,856,298；5,986,047；6,030,086；6,310,078；6,391,633；6,583,272；6,586,398；6,900,292；6,750,369；7,030,226；7,084,245；和7,217,689；美国公开号2002/0155998；2003/0077753；2003/0082749；2003/0143202；2004/0009902；2004/0071694；2004/0091961；2004/0143857；2004/0157293；2004/0175379；2004/0175824；2004/0229318；2004/0248815；2004/0266690；2005/0019914；2005/0026834；2005/0096461；2005/0107297；2005/0107591；2005/0124045；2005/0124564；2005/0137329；2005/0142642；2005/0143292；2005/0153879；2005/0158822；2005/0158832；2005/0170457；2005/0181359；2005/0181482；2005/0192211；2005/0202538；2005/0227289；2005/0244409；2006/0088906；和2006/0111279；和PCT公开号WO9I/05867；WO95/05465；WO99/66054；WO00/24893；WO01/81405；WO00/61637；WO01/36489；WO02/014356；WO02/19963；WO02/20034；WO02/49673；WO02/085940；WO03/029291；WO2003/055526；WO2003/084477；WO2003/094858；WO2004/002417；WO2004/002424；WO2004/009627；WO2004/024761；WO2004/033651；WO2004/035603；WO2004/043382；WO2004/101600；WO2004/101606；WO2004/101611；WO2004/106373；WO2004/018667；WO2005/001025；WO2005/001136；WO2005/021579；WO2005/025606；WO2005/032460；WO2005/051327；WO2005/063808；WO2005/063809；WO2005/070451；WO2005/081687；WO2005/084711；WO2005/103076；WO2005/100403；WO2005/092369；WO2006/50959；WO2006/02646；和WO2006/29094。
用于与该装置一起使用的其他药物产品的例子可包括但不限于，抗体例如(帕木单抗)、XgevaTM(地诺单抗)和ProliaTM(迪诺苏单抗)；其他生物制剂例如(依那西普、TNF受体/Fc融合蛋白、TNF阻滞剂)、(聚乙二醇非格司亭、聚乙二醇化非格司亭、聚乙二醇化G-CSF、聚乙二醇化hu-Met-G-CSF)、(非格司亭、G-CSF、hu-MetG-CSF)和(罗米司亭)；小分子药物例如(西那卡塞)。该装置还可与治疗抗体、多肽、蛋白质或其他化学品例如铁例如菲立莫妥(ferumoxytol)、右旋糖酐铁、葡萄糖酸铁和铁源一起使用。药物产品可为液体形式，或由冻干形式重构。
在特定的示例性蛋白质中有下文所述的具体蛋白质，包括其融合物、片段、类似物、变体或衍生物：
OPGL特异性抗体、肽体和相关蛋白质等等(也称为RANKL特异性抗体、肽体等等)，包括全人源化和人OPGL特异性抗体，特别是全人源化单克隆抗体，包括但不限于PCT公开号WO03/002713中所述的抗体，所述公开关于下述整体并入本文：OPGL特异性抗体和抗体相关蛋白质，特别是具有其中所示序列的那些，特别是但不限于其中指示的那些：9H7；18B2；2D8；2E11；16E1；和22B3，包括具有如其中在图2中所示的SEQ ID NO：2的轻链和/或如其中在图4中所示的SEQ ID NO：4的重链的OPGL特异性抗体，其中的每个个别且特别以引用的方式整体并入本文，完全如同公开于前述公开中；
肌肉生长抑制素结合蛋白、肽体和相关蛋白质等等，包括肌肉生长抑制素特异性肽体，特别是美国公开号2004/0181033和PCT公开号WO2004/058988中所述的那些，所述公开特别在有关下述的部分中以引用的方式整体并入本文：肌肉生长抑制素特异性肽体，包括但不限于mTN8-19家族的肽体，包括具有SEQ ID NOS：305-351的那些，包括TN8-19-1直到TN8-19-49、TN8-19conl和TN8-19con2；具有SEQ ID NOS：357-383的mL2家族的肽体；具有SEQ ID NOS：384-409的mL15家族；具有SEQ ID NOS：410-438的mL17家族；具有SEQ ID NOS：439-446的mL20家族；具有SEQID NOS：447-452的mL21家族；具有SEQ ID NOS：453-454的mL24家族；和具有SEQ ID NOS：615-631的那些，其中的每个个别且特别以引用的方式整体并入本文，完全如同公开于前述公开中；
IL-4受体特异性抗体、肽体和相关蛋白质等等，特别是抑制由IL-4和/或IL-13与受体结合介导的活性的那些，包括PCT公开号WO2005/047331或PCT申请号PCT/US2004/03742和美国公开号2005/112694中所述的那些，所述公开特别在有关下述的部分中以引用的方式整体并入本文：IL-4受体特异性抗体，特别是如其中所述的此类抗体，特别是但不限于其中指定的那些：L1H1；L1H2；L1H3；L1H4；L1H5；L1H6；L1H7；L1H8；L1H9；L1H10；L1H11；L2H1；L2H2；L2H3；L2H4；L2H5；L2H6；L2H7；L2H8；L2H9；L2H10；L2H11；L2H12；L2H13；L2H14；L3H1；L4H1；L5H1；L6H1，其中的每个个别且特别以引用的方式整体并入本文，完全如同公开于前述公开中；
白细胞介素1受体1(“IL1-R1”)特异性抗体、肽体和相关蛋白质等等，包括但不限于美国公开号2004/097712A1中所述的那些，所述公开在有关下述的部分中以引用的方式整体并入本文：IL1-R1特异性结合蛋白，特别是单克隆抗体，尤其是但不限于其中指定的那些：15CA、26F5、27F2、24E12和10H7，其中的每个个别且特别以引用的方式整体并入本文，完全如同公开于前述美国公开中；
Ang2特异性抗体、肽体和相关蛋白质等等，包括但不限于PCT公开号WO03/057134和美国公开号2003/0229023中所述的那些，所述公开各自特别在有关下述的部分中以引用的方式整体并入本文：Ang2特异性抗体和肽体等等，尤其是具有其中所述序列的那些，并且包括但不限于：L1(N)；L1(N)WT；L1(N)1K WT；2xL1(N)；2xL1(N)WT；Con4(N)，Con4(N)1K WT，2xCon4(N)1K；L1C；L1C1K；2xL1C；Con4C；Con4C1K；2xCon4C1K；Con4-L1(N)；Con4-L1C；TN-12-9(N)；C17(N)；TN8-8(N)；TN8-14(N)；Con1(N)，还包括抗Ang2抗体和制剂例如PCT公开号WO2003/030833中所述的那些，所述公开关于此以引用的方式整体并入本文，特别是Ab526；Ab528；Ab531；Ab533；Ab535；Ab536；Ab537；Ab540；Ab543；Ab544；Ab545；Ab546；A551；Ab553；Ab555；Ab558；Ab559；Ab565；AbF1AbFD；AbFE；AbFJ；AbFK；AbG1D4；AbGC1E8；AbH1C12；Ab1A1；Ab1F；AblK，AblP；和AblP，以其如其中所述的多种排列，其中的每个个别且特别以引用的方式整体并入本文，完全如同公开于前述公开中；
NGF特异性抗体、肽体和相关蛋白质等等，包括特别是但不限于美国公开号2005/0074821和美国专利号6,919,426中所述的那些，所述公开特别关于下述以引用的方式整体并入本文：在这点上的NGF特异性抗体和相关蛋白质，包括特别是但不限于其中指定4D4、4G6、6H9、7H2、14D10和14D11的NGF特异性抗体，其中的每个个别且特别以引用的方式整体并入本文，完全如同公开于前述公开中；
CD22特异性抗体、肽体和相关蛋白质等等，例如美国专利号5，789，554中所述的那些，所述专利关于下述以引用的方式整体并入本文：CD22特异性抗体和相关蛋白质，特别是人CD22特异性抗体，例如但不限于人源化和全人抗体，包括但不限于人源化和全人单克隆抗体，特别是包括但不限于人CD22特异性IgG抗体，例如与人-小鼠单克隆hLL2κ链连接的人-小鼠单克隆hLL2γ链二硫化物的二聚体，包括但不限于例如在依帕珠单抗(CAS登记号501423-23-0)中的人CD22特异性全人源化抗体；
IGF-1受体特异性抗体、肽体和相关蛋白质等等，例如PCT公开号WO06/069202中所述的那些，所述公开关于下述以引用的方式整体并入本文：IGF-1受体特异性抗体和相关蛋白质，包括但不限于其中指定下述的IGF-1特异性抗体：L1H1、L2H2、L3H3、L4H4、L5H5、L6H6、L7H7、L8H8、L9H9、L10H10、L11H11、L12H12、L13H13、L14H14、L15H15、L16H16、L17H17、L18H18、L19H19、L20H20、L21H21、L22H22、L23H23、L24H24、L25H25、L26H26、L27H27、L28H28、L29H29、L30H30、L31H31、L32H32、L33H33、L34H34、L35H35、L36H36、L37H37、L38H38、L39H39、L40H40、L41H41、L42H42、L43H43、L44H44、L45H45、L46H46、L47H47、L48H48、L49H49、L50H50、L51H51、L52H52及其IGF-1R-结合片段和衍生物，其中的每个个别且特别以引用的方式整体并入本文，完全如同公开于前述国际公开中；
还在用于在本发明的方法和组合物中使用的抗IGF-1R抗体的非限制性例子中的有下述中所述那些中的每个和全部：
(i)美国公开号2006/0040358(2006年2月23日公开)、2005/0008642(2005年1月13日公开)、2004/0228859(2004年11月18日公开)，包括但不限于例如如其中所述的抗体1A(DSMZ保藏号DSMACC2586)、抗体8(DSMZ保藏号DSM ACC2589)、抗体23(DSMZ保藏号DSM ACC2588)和抗体18；
(ii)PCT公开号WO06/138729(2006年12月28日公开)和WO05/016970(2005年2月24日公开)，和Lu等人，2004，J Biol.Chem.279：2856-65，包括但不限于如其中所述的抗体2F8、A12和IMC-A12；
(iii)PCT公开号WO07/012614(2007年2月1日公开)、WO07/000328(2007年1月4日公开)、WO06/013472(2006年2月9日公开)、WO05/058967(2005年6月30日公开)和WO03/059951(2003年7月24日公开)；
(iv)美国公开号2005/0084906(2005年4月21日公开)，包括但不限于如其中所述的抗体7C10、嵌合抗体C7C10、抗体h7C10、抗体7H2M、嵌合抗体*7C10、抗体GM607、人源化抗体7C10形式1、人源化抗体7C10形式2、人源化抗体7C10形式3和抗体7H2HM；
(v)美国公开号2005/0249728(2005年11月10日公开)、2005/0186203(2005年8月25日公开)、2004/0265307(2004年12月30日公开)、和2003/0235582(2003年12月25日公开)和Maloney等人，2003，Cancer Res.63：5073-83，包括但不限于如其中所述的抗体EM164、表面重塑的EM164、人源化EM164、huEM164v1.0、huEM164v1.1、huEM164v1.2和huEM164v1.3；
(vi)美国专利号7,037,498(2006年5月2日授权)、美国公开号2005/0244408(2005年11月30日公开)和2004/0086503(2004年5月6日公开)，和Cohen,等人，2005，Clinical Cancer Res.11：2063-73，例如抗体CP-751，871，包括但不限于由杂交瘤产生的抗体中的每个，所述杂交瘤具有ATCC登记号PTA-2792、PTA-2788、PTA-2790、PTA-2791、PTA-2789、PTA-2793，以及如其中所述的抗体2.12.1、2.13.2、2.14.3、3.1.1、4.9.2和4.17.3；
(vii)美国公开号2005/0136063(2005年6月23日公开)和2004/0018191(2004年1月29日公开)，包括但不限于如其中所述的抗体19D12和这样的抗体，所述抗体包含由在编号PTA-5214下保藏于ATCC的质粒15H12/19D12HCA(γ4)中的多核苷酸编码的重链，和由在编号PTA-5220下保藏于ATCC的质粒15H12/19D12LCF(κ)中的多核苷酸编码的轻链；以及
(viii)美国公开号2004/0202655(2004年10月14日公开)，包括但不限于如其中所述的抗体PINT-6A1、PINT-7A2、PINT-7A4、PINT-7A5、PINT-7A6、PINT-8A1、PINT-9A2、PINT-11A1、PINT-11A2、PINT-11A3、PINT-11A4、PINT-11A5、PINT-11A7、PINT-11A12、PINT-12A1、PINT-12A2、PINT-12A3、PINT-12A4和PINT-12A5；其中的每个和全部均特别关于靶向IGF-1受体的上述抗体、肽体和相关蛋白质等等以引用的方式整体并入本文；
B-7相关蛋白质1特异性抗体、肽体、相关蛋白质等等(“B7RP-1”，在文献中也称为B7H2、ICOSL、B7h和CD275)，特别是B7RP特异性全人单克隆IgG2抗体，特别是结合B7RP-1的第一免疫球蛋白样结构域中的表位的全人IgG2单克隆抗体，尤其是抑制B7RP-1与其在活化T细胞上的天然受体ICOS的相互作用的那些，尤其是在前述方面的全部中，公开于美国公开号2008/0166352和PCT公开号WO07/011941中的那些，所述公开关于下述以引用的方式整体并入本文：此类抗体和相关蛋白质，包括但不限于其中如下指定的抗体：16H(分别具有其中的轻链可变和重链可变序列SEQ ID NO：1和SEQ ID NO：7)；5D(分别具有其中的轻链可变和重链可变序列SEQ IDNO：2和SEQ ID NO：9)；2H(分别具有其中的轻链可变和重链可变序列SEQID NO：3和SEQ ID NO：10)；43H(分别具有其中的轻链可变和重链可变序列SEQ ID NO：6和SEQ ID NO：14)；41H(分别具有其中的轻链可变和重链可变序列SEQ ID NO：5和SEQ ID NO：13)；和15H(分别具有其中的轻链可变和重链可变序列SEQ ID NO：4和SEQ ID NO：12)，其中的每个个别且特别以引用的方式整体并入本文，完全如同公开于前述美国公开中；
IL-15特异性抗体、肽体和相关蛋白质等等，例如特别是人源化单克隆抗体，特别是例如公开于美国公开号2003/0138421；2003/023586；和2004/0071702；和美国专利号7，153,507中的抗体，所述公开中的每个关于下述以引用的方式整体并入本文：IL-15特异性抗体和相关蛋白质，包括肽体，包括特别是例如但不限于HuMax IL-15抗体和相关蛋白质，例如146B7；
IFNγ特异性抗体、肽体和相关蛋白质等等，尤其是人IFNγ特异性抗体，特别是全人抗IFNγ抗体，例如美国公开号2005/0004353中所述的那些，所述公开关于下述以引用的方式整体并入本文：IFNγ特异性抗体，特别是例如其中指定1118；1118*；1119；1121；和1121*的抗体。这些抗体各自的重链和轻链的完整序列，以及其重链和轻链可变区以及互补决定区的序列，各自个别且特别以引用的方式整体并入本文，完全如同公开于前述美国公开和Thakur等人，Mol.Immunol.36：1107-1115(1999)中。此外，前述美国公开中提供的这些抗体的性质的描述也以引用的方式整体并入本文。特异性抗体包括具有SEQ ID NO：17的重链和SEQ ID NO：18的轻链的抗体；具有SEQ IDNO：6的重链可变区和SEQ ID NO：8的轻链可变区的抗体；具有SEQ IDNO：19的重链和SEQ ID NO：20的轻链的抗体；具有SEQ ID NO：10的重链可变区和SEQ ID NO：12的轻链可变区的抗体；具有SEQ ID NO：32的重链和SEQ ID NO：20的轻链的抗体；具有SEQ ID NO：30的重链可变区和SEQ IDNO：12的轻链可变区的抗体；具有SEQ ID NO：21的重链和SEQ ID NO：22的轻链的抗体；具有SEQ ID NO：14的重链可变区和SEQ ID NO：16的轻链可变区的抗体；具有SEQ ID NO：21的重链和SEQ ID NO：33的轻链的抗体；以及具有SEQ ID NO：14的重链可变区和SEQ ID NO：31的轻链可变区的抗体，如前述美国公开中公开的。考虑的具体抗体是抗体1119，其如前述美国公开中公开的，并且具有如其中公开的SEQ ID NO：17的完整重链和具有如其中公开的SEQ ID NO：18的完整轻链。
TALL-1特异性抗体、肽体和相关蛋白质等等，及其他TALL特异性结合蛋白，例如美国公开号2003/0195156和2006/0135431中所述的那些，所述公开各自关于下述以引用的方式整体并入本文：TALL-1结合蛋白，特别是表4和5B的分子，其中的每个个别且特别以引用的方式整体并入本文，完全如同公开于前述美国公开中；
甲状旁腺激素(“PTH”)特异性抗体、肽体和相关蛋白质等等，例如美国专利号6,756,480中所述的那些，所述专利特别在有关结合PTH的蛋白质的部分中以引用的方式整体并入本文；
血小板生成素受体(“TPO-R”)特异性抗体、肽体和相关蛋白质等等，例如美国专利号6,835,809中所述的那些，所述专利特别在有关结合TPO-R的蛋白质的部分中以引用的方式整体并入本文；
肝细胞生长因子(“HGF”)特异性抗体、肽体和相关蛋白质等等，包括靶向HGF/SF：cMet轴(HGF/SF：c-Met)的那些，例如美国公开号2005/0118643和PCT公开号WO2005/017107中所述的中和肝细胞生长因子/离散(HGF/SF)的全人单克隆抗体，美国专利号7,220,410中所述的huL2G7，美国专利号5,686,292和6,468,529以及PCT公开号WO96/38557中所述的OA-5d5，所述专利各自特别在有关结合HGF的蛋白质的部分中以引用的方式整体并入本文；
TRAIL-R2特异性抗体、肽体、相关蛋白质等等，例如美国专利号7,521,048中所述的那些，所述专利特别在有关结合TRAIL-R2的蛋白质的部分中以引用的方式整体并入本文；
激活素A特异性抗体、肽体、相关蛋白质等等，包括但不限于美国公开号2009/0234106中所述的那些，所述公开特别在有关结合激活素A的蛋白质的部分中以引用的方式整体并入本文；
PCSK9(前蛋白转化酶枯草杆菌蛋白酶/Kexin)特异性抗体、肽体、相关蛋白质等等，包括但不限于美国专利号8,030,457、WO1I/0027287和WO09/026558中所述的那些，所述专利特别在有关结合PCSK9的蛋白质的部分中以引用的方式整体并入本文；
TGF-β特异性抗体、肽体、相关蛋白质等等，包括但不限于美国专利号6,803,453和美国公开号2007/0110747中所述的那些，所述专利各自特别在有关结合TGF-β的蛋白质的部分中以引用的方式整体并入本文；
淀粉样蛋白-β蛋白质特异性抗体、肽体、相关蛋白质等等，包括但不限于PCT公开号WO2006/081171中所述的那些，所述公开特别在有关结合淀粉样蛋白-β蛋白质的蛋白质的部分中以引用的方式整体并入本文。考虑的一种抗体是如公开于国际公开中的抗体，其具有包含SEQ ID NO：8的重链可变区和具有SEQ ID NO：6的轻链可变区；
c-Kit特异性抗体、肽体、相关蛋白质等等，包括但不限于公开号2007/0253951中所述的那些，所述公开特别在有关结合c-Kit和/或其他干细胞因子受体的蛋白质的部分中以引用的方式整体并入本文；
OX40L特异性抗体、肽体、相关蛋白质等等，包括但不限于美国申请号1I/068,289中所述的那些，所述申请特别在有关结合OX40L和/或OX40受体的其他配体的蛋白质的部分中以引用的方式整体并入本文；以及
其他示例性蛋白质可包括(阿替普酶，tPA)；(达依泊汀α)；(依泊汀α或促红细胞生成素)；(干扰素β-1a)；(托西莫单抗，抗CD22单克隆抗体)；(干扰素-β)；(阿仑珠单抗，抗CD52单克隆抗体)；(依泊汀δ)；(硼替佐米)；MLN0002(抗α4β7mAb)；MLN1202(抗CCR2趋化因子受体mAb)；(依那西普，TNF受体/Fc融合蛋白，TNF阻滞剂)；(依泊汀α)；(西妥昔单抗，抗EGFR/HER1/c-ErbB-1)；(促生长激素，人生长激素)；(曲妥珠单抗，抗HER2/neu(erbB2)受体mAb)；(促生长激素，人生长激素)；(阿达木单抗)；胰岛素溶液；(干扰素αcon-1)；(奈西立肽；重组人B-型利钠肽(hBNP)；(阿那白滞素)；(沙格司亭，rhuGM-CSF)；(依帕珠单抗，抗CD22mAb)；BenlystaTM(贝利单抗B，贝利木单抗，抗BlyS mAb)；(替奈普酶，t-PA类似物)；(甲氧基聚乙二醇-依泊汀β)；(吉妥珠单抗奥佐米星)；(依法珠单抗)；(赛妥珠单抗，CDP870)；SolirisTM(依库珠单抗)；培克珠单抗(抗C5补体)；(MEDI-524)；(雷珠单抗)；(17-1A，依决洛单抗)；(乐德木单抗)；TheraCim hR3(尼妥珠单抗)；Omnitarg(培妥珠单抗，2C4)；(IDM-1)；(B43.13)；(维西珠单抗)；美坎珠单抗(huC242-DM1)；(依泊汀β)；(奥普瑞白介素，人白细胞介素-11)；(聚乙二醇化非格司亭，聚乙二醇化G-CSF，聚乙二醇化hu-Met-G-CSF)；(非格司亭，G-CSF，hu-MetG-CSF)；Orthoclone(莫罗单抗-CD3，抗CD3单克隆抗体)；(依泊汀α)；(英夫利昔单抗，抗TNFα单克隆抗体)；(阿昔单抗，抗GP lIb/Ilia受体单克隆抗体)；(抗IL6受体mAb)；(贝伐珠单抗)、HuMax-CD4(扎木单抗)；(利妥昔单抗，抗CD20mAb)；(埃罗替尼)；Roferon--(干扰素α-2a)；(巴利昔单抗)；(鲁米考昔)；(帕利珠单抗)；146B7-CHO(抗IL15抗体，参见美国专利号7,153,507)；(那他珠单抗，抗α4整联蛋白mAb)；(MDX-1303，抗炭疽杆菌(B.anthracis)保护性抗原mAb)；ABthraxTM；(帕木单抗)；(奥马珠单抗)；ETI211(抗MRSA mAb)；IL-1阱(人IgG1的Fc部分和两种IL-1受体组分(I型受体和受体辅助蛋白)的细胞外结构域)；VEGF阱(与IgG1Fc融合的VEGFR1的Ig结构域)；(达克珠单抗)；(达克珠单抗，抗IL-2RαmAb)；(替伊莫单抗)；(依泽替米贝)；(阿塞西普，TACI-Ig)；抗CD80单克隆抗体(加利昔单抗)；抗CD23mAb(鲁昔单抗)；BR2-Fc(huBR3/huFc融合蛋白，可溶性BAFF拮抗剂)；CNTO148(戈利木单抗，抗TNFαmAb)；HGS-ETR1(马帕木单抗；人抗TRAIL受体-1mAb)；HuMax-CD20(奥瑞珠单抗，抗CD20人mAb)；HuMax-EGFR(扎鲁木单抗)；M200(伏洛昔单抗，抗α5β1整联蛋白mAb)；MDX-010(易普单抗，抗CTLA-4mAb和VEGFR-1(IMC-18F1)；抗BR3mAb；抗艰难梭菌(C.difficile)毒素A和毒素B C mAb MDX-066(CDA-1)和MDX-1388)；抗CD22dsFv-PE38缀合物(CAT-3888和CAT-8015)；抗CD25mAb(HuMax-TAC)；抗CD3mAb(NI-0401)；阿德木单抗；抗CD30mAb(MDX-060)；MDX-1333(抗IFNAR)；抗CD38mAb(HuMax CD38)；抗CD40L mAb；抗Cripto mAb；抗CTGF特发性肺纤维化I期纤维蛋白原(FG-3019)；抗CTLA4mAb；抗嗜酸性粒细胞活化趋化因子1mAb(CAT-213)；抗FGF8mAb；抗神经节苷脂GD2mAb；抗神经节苷脂GM2mAb；抗GDF-8人mAb(MYO-029)；抗GM-CSF受体mAb(CAM-3001)；抗HepC mAb(HuMax HepC)；抗IFNαmAb(MEDI-545，MDX-1103)；抗IGF1R mAb；抗IGF-1R mAb(HuMax-Inflam)；抗IL12mAb(ABT-874)；抗IL12/IL23mAb(CNTO1275)；抗IL13mAb(CAT-354)；抗IL2Ra mAb(HuMax-TAC)；抗IL5受体mAb；抗整联蛋白受体mAb(MDX-018，CNTO95)；抗IP10溃疡性结肠炎mAb(MDX-1100)；抗LLY抗体；BMS-66513；抗甘露糖受体/hCGβmAb(MDX-1307)；抗间皮素dsFv-PE38缀合物(CAT-5001)；抗PD1mAb(MDX-1106(ONO-4538))；抗PDGFRα抗体(IMC-3G3)；抗TGFβ mAb(GC-1008)；抗TRAIL受体-2人mAb(HGS-ETR2)；抗TWEAK mAb；抗VEGFR/Flt-1mAb；抗ZP3mAb(HuMax-ZP3)；NVS抗体#1；和NVS抗体#2。
Claims (27)
1.一种注射器，所述注射器包括：
容器，所述容器包括壁，所述壁限定孔和与所述孔的第一端部流体连通的开口；和
跨过所述容器的开口而设置的密封组件，所述密封组件包括具有限定所述密封组件的内表面的内表面的柔性壁，以及被设置在所述柔性壁外部的洁净屏障，以限定在所述柔性壁和所述洁净屏障之间的封闭的洁净空间，所述容器和所述密封组件限定填充有药物产品的闭合的无菌储库；
流体递送系统，所述流体递送系统包括洁净的、无护套的刚性容器针，所述刚性容器针具有这样的尖，所述尖被设置成在存储状态中穿过所述洁净屏障且进入所述洁净空间中，并且被设置成在递送状态中穿过所述密封组件的柔性壁的内表面进入所述无菌储库内；以及
致动器，所述致动器适于将所述容器针从所述存储状态移动到所述递送状态。
2.根据权利要求1所述的注射器，其中所述容器的壁包括刚性壁。
3.根据权利要求1所述的注射器，其中所述容器的壁包括柔性壁。
4.根据权利要求1所述的注射器，其中所述柔性壁限定被设置成跨越开口且固定地附接到所述容器的壁的隔膜。
5.根据权利要求1所述的注射器，其中所述密封组件限定可沿所述孔移动的阻挡件。
6.根据权利要求5所述的注射器，其中所述容器的壁限定相对所述阻挡件的闭合端部和所述阻挡件被设置在其中的开放端部。
7.根据权利要求1所述的注射器，还包括阻挡件，所述阻挡件被设置在所述孔的第二端部内并可沿所述孔移动。
8.根据权利要求1所述的注射器，其中，所述柔性壁和所述洁净屏障各自限定可沿所述孔移动的阻挡件。
9.根据权利要求1所述的注射器，其中所述容器包括与在所述洁净屏障和所述柔性壁之间的空间流体连通的通风孔。
10.根据权利要求9所述的注射器，其中所述通风孔在所述洁净屏障中形成。
11.根据权利要求9所述的注射器，其中所述通风孔在所述容器的壁的内表面内形成。
12.根据权利要求1所述的注射器，其中所述柔性壁和所述洁净屏障各自限定被设置成跨越所述开口且固定地附接到所述容器的壁的隔膜，所述容器还包括阻挡件，所述阻挡件被设置在所述孔的第二端部内并可沿所述孔移动。
13.根据权利要求1-3中任一项所述的注射器，其中所述流体递送系统包括洁净的柔性管道，所述洁净的柔性管道在第一端部处连接到所述刚性容器针，并且在第二端部处连接到容纳在洁净罩内的洁净的刚性注射针，所述洁净罩隔离所述洁净的刚性注射针。
14.根据权利要求1-3中任一项所述的注射器，其中所述致动器适于在所述存储状态和所述递送状态之间反复移动所述容器针。
15.根据权利要求1-3中任一项所述的注射器，其中所述致动器适于在接受输入后延迟所述容器针从所述存储状态到所述递送状态的移动。
16.根据权利要求1-3中任一项所述的注射器，所述注射器还包括联接到所述致动器的机械、机电或电输入装置。
17.根据权利要求1-3中任一项所述的注射器，其中所述药物产品包括一定体积的红细胞生成刺激剂。
18.根据权利要求1-3中任一项所述的注射器，其中所述药物产品包括一定体积的粒细胞集落刺激因子。
19.根据权利要求1-3中任一项所述的注射器，其中所述药物产品包括一定体积的TNF阻滞剂。
20.根据权利要求1-3中任一项所述的注射器，其中所述药物产品包括一定体积的聚乙二醇化粒细胞集落刺激因子。
21.根据权利要求1-3中任一项所述的注射器，其中所述药物产品包括一定体积的白细胞介素受体特异性抗体。
22.根据权利要求1-3中任一项所述的注射器，其中所述药物产品包括一定体积的IGF受体(胰岛素生长因子受体)特异性抗体。
23.根据权利要求1-3中任一项所述的注射器，其中所述药物产品包括一定体积的TGF特异性抗体。
24.根据权利要求1-3中任一项所述的注射器，其中所述药物产品包括一定体积的PCSK9(前蛋白转化酶枯草杆菌蛋白酶/Kexin 9型)特异性抗体。
25.一种装配注射器的方法，所述方法包括：
在无菌条件下用药物产品填充容器的无菌储库，所述储库由所述容器的壁、设置在所述容器的孔的第一端中的密封组件以及可动地设置在所述孔的第二端部中的阻挡件限定，其中，所述密封组件包括具有限定所述密封组件的内表面的内表面的柔性壁，以及被设置在所述柔性壁外部的洁净屏障，以限定在所述柔性壁和所述洁净屏障之间的封闭的洁净空间；
在填充所述无菌储库后，在洁净室条件下将洁净的、无护套的刚性容器针的尖插入穿过所述洁净屏障且进入所述密封组件的所述洁净空间中，以限定存储状态；
在洁净室条件下将所述容器针附接到致动器，所述致动器适于将所述容器针从所述存储状态移动到递送状态，其中所述容器针被设置成穿过所述密封组件的所述柔性壁的内表面进入所述无菌储库内。
26.根据权利要求25所述的方法，其中所述容器的壁是刚性壁。
27.根据权利要求25所述的方法，其中所述容器的壁是柔性壁。
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| CN102149416A (zh) * | 2008-09-10 | 2011-08-10 | 弗·哈夫曼-拉罗切有限公司 | 供治疗药物使用的传送装置 |
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