CN107427411B - 具有多次使用可丢弃套件的多流体递送系统及其特征 - Google Patents
具有多次使用可丢弃套件的多流体递送系统及其特征 Download PDFInfo
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Abstract
多次使用可丢弃套件(MUDS)具有至少一个针筒,针筒具有近端和沿着纵向轴线与近端间隔开的远端。MUDS还具有在针筒内部之内在近端与远端之间可往复地移动的柱塞。歧管与至少一个针筒的远端流体连通。至少一个阀与针筒内部流体连通。至少一个阀在用流体填充针筒内部的填充位置与从针筒内部递送流体的递送位置之间可操作。当至少一个阀在递送位置中时,至少一个连接端口与歧管和针筒内部流体连通。还提供了具有医用连接器和MUDS的多流体递送系统。还描述了MUDS系统的各种特征。
Description
相关申请的交叉引用
本申请要求2015年10月15日提交的申请号为62/242,090、题为“AttachmentConfigurations for Syringe and Manifold”的美国临时申请;2015年10月15日提交的申请号为62/242,101、题为“Rotatable Valve for Multiple Use Disposable System”的美国临时申请;以及2015年1月9日提交的申请号为62/101,752、题为“Multi-Fluid DeliverySystem and Single-Use Disposable Set Connector Therefor”的美国临时申请的优先权,其每一个的公开通过本引用以其整体整合于本文。
技术领域
本公开总体上涉及多流体递送系统的领域以及用于其的单次使用可丢弃套件(SUDS)连接器,并且,更特别地,涉及具有多患者可丢弃套件的多流体递送系统,多患者可丢弃套件具有可旋转阀,可旋转阀配置为用于将流体递送到使用SUDS连接器的患者。
背景技术
在许多医疗诊断和治疗程序中,医疗从业者,比如医师,用一个或多个医疗流体注射患者。近年,已经开发了若干用于流体(比如造影剂溶液(常简称为“造影剂”)、淋洗剂(比如生理盐水),以及其他医疗流体的加压注射的医疗流体递送系统,用于诸如血管造影术、计算机断层扫描(CT)、超声、磁共振成像(MRI)、正电子发射断层扫描(PET)以及其他成像程序的程序中。总体上,这些医疗流体递送系统设计为将预设量的流体以预设流率递送。
在一些注射程序中,医疗从业者将导管或针置入患者的血管或动脉中。通过与流体注射器系统相接的管路和连接器,导管或针连接到手动或自动流体注射器系统。自动流体注射器系统典型地包含连接到至少一个流体注射器的至少一个针筒,至少一个流体注射器具有例如动力线性活塞。至少一个针筒包含例如造影剂源和/或淋洗流体源。医疗从业者将设置输入到流体注射器的电子控制系统中,用于固定容积的造影剂和/或生理盐水以及每个的固定注射速率。单次使用可丢弃套件(SUDS)连接器和相关联的管路连接到流体注射器系统,以向患者递送一种或多种流体。
尽管在医疗领域中已知各种手动和自动流体递送系统,仍需要改善的多流体递送系统,适配为用于在医疗诊断和治疗程序期间将一种或多种流体供给到患者的这样的程序中。此外,医疗领域中还需要改善的SUDS连接器,其可以与多流体递送系统使用,以便于向患者递送一种或多种流体。医疗领域仍需要改善的医疗设备和系统,其用来在各种医疗程序期间向患者供给流体。
发明内容
鉴于前文,存在对于将医疗组件的单次使用部分连接到组件的多次使用部分的医用连接器组件的需求。此外,存在对于使用一个或多个多剂量容器将多流体递送到多个患者的流体递送系统的需求。组件应配置为保持铜过组件的单次使用和多次使用部分的流体路径的无菌性,并且特别地,应保持组件的可重复使用部分的无菌性。此外,系统应布置为允许自动预备(priming),限定为从流体管线移除空气,以易于流体注射。
因此,本文提供了配置为解决这些需求中的一些或全部的医用连接器。根据一方面,医用连接器可以包含流体入口端口,配置为用于与多次使用可丢弃套件(MUDS)的连接端口的可移除接合,以与之建立流体连接,以及废弃物出口端口,配置为用于与MUDS的废弃物入口端口可移除地接合,以与之建立流体连接。患者流体管线可在第一端处连接到流体入口端口,并且在第二端处连接到废弃物出口端口。穿过患者流体管线的流体流动可以为从第一端到第二端单方向的。患者流体管线可以配置为用于从废弃物出口端口可逆地断开,以向患者递送流体。
另一方面,可以提供锁定机构,以将医用连接器可移除地固定到MUDS。流体入口端口可以包含围绕流体入口端口的至少一部分的套管。流体入口端口可以成型为防止与MUDS的废弃物入口端口连接,并且其中废弃物出口端口成型为防止与MUDS的连接端口连接。患者流体管线的第二端可以具有连接器,其配置为用于与废弃物出口端口的可移除地接合。医用连接器可以具有单向阀,所述单向阀配置为用于穿过流体入口端口到患者流体管线中的单方向流动。可替代地,单向阀可以位于患者流体管线中。至少一个感测元件可以配置为用于与MUDS上的或注射器上的至少一个传感器相互作用,传感器配置为用于检测至少一个感测元件的存在或缺失,其指示医用连接器已经适当地插入或安装。
另一方面,可以在连接到多个针筒中的至少一个的框架上提供至少一个连接端口。至少一个连接端口可以通过递送管线与歧管流体连通。多个针筒中的每一个可以具有带有尖刺的填充管线,尖刺配置为用于连接到体相流体源。每个流体管线可以配置为,当至少一个阀在填充位置中时,通过针筒的远端上的填充端口填充对应的针筒内部。至少一个阀可以具有槽,所述槽用于与动力注射器上的对应的叶片接合,所述叶片配置为在填充位置与递送位置之间旋转所述至少一个阀。叶片设计为,通过叶片相对于槽的旋转,直到当叶片和槽在正确的旋转位置中而使叶片座置在槽中,以特定的配置与槽自对准和可逆的接合。
另一方面,多流体递送系统可以包含动力注射器,动力注射器包括封闭多个可往复地操作的活塞元件的外壳。外壳可以具有接收空间,所述接收空间配置为用于可移除地接收MUDS的多个针筒。接收空间可以具有底部板和由后侧壁与底部板间隔开的顶部板,使得在顶部板与底部板之间轴向地支撑MUDS的多个针筒。至少一个导轨可以与接收空间相关联。至少一个导轨在朝向后侧壁的插入方向上变窄,以将MUDS引导到接收空间中。
另一方面,多个体相流体连接器可以配置为用于将MUDS的多个针筒与至少一个体相流体源连接。顶部板可以具有多个槽,所述槽配置为用于接收MUDS的多个针筒中的至少一个的远端。多个槽中的每一个可以具有配合凹陷,以接收至少一个针筒的锥形远端,使得当MUDS被接收在接收空间中时,锥形远端接合配合凹陷。顶部板可以在第一位置与第二位置之间可移动,第一位置配置为用于MUDS在接收空间内的插入和移除,并且第二位置配置为用于通过将至少一个针筒的锥形远端固定在对应的配合凹陷中来将MUDS锁定在接收空间内。顶部板可以具有闩锁,以将顶部板锁定在第二位置中。另一方面,当系统上的进入门关闭且可选地锁定时,顶部板可以锁定在第二位置中;并且当系统上的进入门打开时,顶部板可以移动到第一位置。至少一个耦接器可以配置为用于接合MUDS的多个针筒中的至少一个上的至少一个阀。至少一个耦接器是具有叶片的可旋转耦接器,所述叶片配置为用于与形成在MUDS上的至少一个阀上上的槽自对准。
MUDS可以包含至少一个针筒,其具有近端和沿着纵向轴线与近端间隔开的远端,以及在针筒内部之内在近端和远端之间可往复地移动的柱塞。MUDS还可以包含与至少一个针筒的远端流体连通的歧管。至少一个阀可以与针筒内部流体连通。至少一个阀可以在用流体填充针筒内部的填充位置与从针筒内部递送流体的递送位置之间可操作。MUDS可以具有至少一个连接端口,当至少一个阀在递送位置中时,至少一个连接端口与歧管和针筒内部流体连通。
根据其他方面,至少一个阀可以具有阀头,阀头具有凹陷到阀头中的槽。槽可以成型为接收耦接机构的至少一部分,以当耦接机构接合至少一个阀的槽时,在填充位置与递送位置之间旋转至少一个阀。槽可以在从阀的远端到阀的近端的方向上变窄。至少一个阀可以在针筒的远端处的阀接收腔内在填充位置与递送位置之间可旋转。在填充位置中,至少一个阀可以操作为通过与体相流体源流体连通的填充端口来填充针筒内部,并且通过与歧管流体连通的排放出口从针筒内部递送流体。可以在连接到多个针筒中的至少一个的框架上提供至少一个连接端口。至少一个连接端口可以通过递送管线与歧管流体连通。至少一个连接端口可以具有与废弃物储器流体连通的废弃物端口。填充管线可以具有尖刺,以连接到体相流体源。当至少一个阀在填充位置中时,流体管线可以通过歧管用流体填充针筒内部。
根据其他方面,多流体注射器系统可以包含动力注射器,动力注射器具有封闭至少一个可往复地操作的活塞元件的外壳,以及具有至少一个针筒的MUDS,针筒具有近端和沿着纵向轴线与近端间隔开的远端,以及通过至少一个活塞元件在针筒内部之内在近端与远端之间可往复地移动的柱塞。歧管可以与至少一个针筒的远端流体连通。至少一个阀可以与针筒内部流体连通。至少一个阀可以在用流体填充针筒内部的填充位置与从针筒内部递送流体的递送位置之间可操作。当至少一个阀在递送位置中时,至少一个连接端口可以与歧管和针筒内部流体连通。可以提供耦接机构,以在填充位置与递送位置之间操作至少一个阀。
根据其他方面,耦接机构可以具有叶片,并且至少一个阀可以具有槽,所述槽成型为接收耦接机构的叶片。当耦接机构的叶片被接收在至少一个阀的槽内时,耦接机构的旋转可以使得至少一个阀旋转。耦接机构可以与至少一个阀自对准,以将耦接机构的叶片接收在至少一个阀的槽内。耦接机构可以弹簧加载,以随着耦接机构的叶片旋转到与至少一个阀的槽对准时,保持与至少一个阀接触。当耦接机构的叶片与至少一个阀的槽对准时,叶片可以在有弹力的弹性构件的回复动作下被驱策到槽中。可以提供驱动机构,以操作耦接机构。驱动机构可以旋转耦接机构。叶片可以具有至少一个倾斜表面,所述倾斜表面相对于至少一个阀的纵向轴线成角度。
根据其他方面,MUDS可以包含多个针筒,每个针筒具有近端和沿着纵向轴线与近端间隔开的远端,以及在针筒内部之内在近端和远端之间可往复地移动的柱塞。歧管可以连接到多个针筒中的每一个的远端。至少一个阀可以与歧管相关联。至少一个阀可以在填充位置与递送位置之间可操作,所述填充位置用于通过歧管填充多个针筒中的至少一个的针筒内部,所述递送位置用于通过歧管从多个针筒中的至少一个的针筒内部递送流体。当至少一个阀在填充位置中时,至少一个填充管线可以与多个针筒中的至少一个的内部和针筒内部流体连通。当至少一个阀在递送位置中时,至少一个连接端口可以与歧管和多个针筒中的至少一个的针筒内部流体连通。至少一个阀可以具有阀头,阀头具有凹陷到阀头中的槽。槽可以成型为接收耦接机构的至少一部分,以当耦接机构接合至少一个阀的槽时,在填充位置与递送位置之间旋转至少一个阀。
根据各个其他方面,MUDS可以根据以下项中的一个或多个来表征:
项1:多次使用可丢弃套件(MUDS)包括:多个针筒,每个针筒具有近端和沿着纵向轴线与近端间隔开的远端,以及在针筒内部之内在近端和远端之间可往复地移动的柱塞;与多个针筒中的每一个的远端流体连通的歧管;至少一个阀,与多个针筒中的至少一个的远端流体连通,至少一个阀在填充位置与递送位置之间可操作,所述填充位置用于通过歧管填充多个针筒中的至少一个的针筒内部,所述递送位置用于通过歧管从多个针筒中的至少一个的针筒内部递送流体;以及至少一个连接端口,当至少一个阀在递送位置中时,与歧管流体连通。
项2:项1的MUDS,其中在连接到多个针筒中的至少一个的框架上提供至少一个连接端口。
项3:项1或2的MUDS,其中至少一个连接端口通过递送管线与歧管流体连通。
项4:项1-3中任一项的MUDS,还包括与废弃物储器流体连接的废弃物端口。
项5:项1-4中任一项的MUDS,其中多个针筒中的每一个包括具有尖刺的填充管线,尖刺配置为用于连接到体相流体源,并且其中每个流体管线配置为用于当至少一个阀在填充位置中时,通过歧管填充针筒内部。
项6:项1-5中任一项的MUDS,其中至少一个阀包括槽,以与叶片接合,叶片在填充位置与递送位置之间旋转槽。
项7:多流体注射器系统,包括:动力注射器,包括封闭多个可往复地操作的活塞元件的外壳;接收空间,配置为用于可移除地接收多次使用可丢弃套件(MUDS)的多个针筒,接收空间包括底部板和由后侧壁与底部板间隔开的顶部板,使得在顶部板与底部板之间轴向地支撑MUDS的多个针筒;以及与接收空间相关联的至少一个导轨,其中至少一个导轨在朝向后侧壁的插入方向变窄,以将MUDS引导到接收空间中。
项8:项7的多流体注射器系统,还包括多个体相流体连接器,配置为用于将MUDS与至少一个体相流体源连接。
项9:项7或8的多流体注射器系统,其中顶部板限定多个槽,配置为用于接收MUDS的多个针筒中的至少一个,并且其中多个槽中的每一个限定配合凹陷,以接收至少一个针筒的锥形远端,使得当MUDS被接收在接收空间中时,锥形远端接合配合凹陷。
项10:项7-9中任一项的多流体注射器系统,其中顶部板在第一位置与第二位置之间可移动,第一位置配置为用于MUDS在接收空间内的插入和移除,并且第二位置配置为用于将MUDS锁定在接收空间内。
项11:项10的多流体注射器系统,其中顶部板包括闩锁,用于将顶部板锁定在第二位置中。
项12:项7-11中任一项的多流体注射器系统,还包括至少一个耦接器,配置为用于接合MUDS上的至少一个阀。
项13:项12的多流体注射器系统,其中至少一个耦接器为可旋转耦接器,其具有叶片,叶片配置为用于与形成在MUDS上的至少一个阀上的槽自对准。
项14:MUDS,包括:至少一个针筒,具有近端和沿着纵向轴线与近端间隔开的远端,以及在针筒内部之内在近端和远端之间可往复地移动的柱塞;与至少一个针筒的远端流体连通的歧管;至少一个阀,与针筒内部流体连通,至少一个阀在用流体填充针筒内部的填充位置与从针筒内部递送流体的递送位置之间可操作;以及至少一个连接端口,当至少一个阀在递送位置中时,至少一个连接端口与歧管和针筒内部流体连通。
项15:根据项14的MUDS,其中至少一个阀具有阀头,阀头具有凹陷到阀头中的槽。
项16:根据项15的MUDS,其中槽成型为接收耦接机构的至少一部分,以当耦接机构接合至少一个阀的槽时,在填充位置与递送位置之间旋转至少一个阀。
项17:根据项15或16的MUDS,其中槽在从阀的远端到阀的近端的方向上变窄。
项18:根据项14-17中任一项的MUDS,其中至少一个阀在针筒的远端处的阀接收腔内在填充位置与递送位置之间可旋转。
项19:根据项14-18中任一项的MUDS,其中,在填充位置中,至少一个阀为可操作的,以通过与体相流体源流体连通的填充端口填充针筒内部,并且通过与歧管流体连通的排放出口从针筒内部递送流体。
项20:根据项14-19中任一项的MUDS,其中在连接到多个针筒中的至少一个的框架上提供至少一个连接端口。
项21:根据项14-20中任一项的MUDS,其中至少一个连接端口通过递送管线与歧管流体连通。
项22:根据项14-21中任一项的MUDS,其中至少一个连接端口具有与废弃物储器流体连通的废弃物端口。
项23:根据项14-22中任一项的MUDS,还包括填充管线,填充管线具有用于连接到体相流体源的尖刺,其中当至少一个阀在填充位置中时,流体管线通过歧管用流体填充针筒内部。
项24:多流体注射器系统,包括:动力注射器,包括封闭至少一个可往复地操作的活塞元件的外壳;MUDS,可连接到动力流体注射器,MUDS包括:至少一个针筒,具有近端和沿着纵向轴线与近端间隔开的远端,以及通过至少一个活塞元件在针筒内部之内在近端与远端之间可往复地移动的柱塞;与至少一个针筒的远端流体连通的歧管;至少一个阀,与针筒内部流体连通,至少一个阀在用流体填充针筒内部的填充位置与从针筒内部递送流体的递送位置之间可操作;以及至少一个连接端口,当至少一个阀在递送位置中时,至少一个连接端口与歧管和针筒内部流体连通;以及耦接机构,用于在填充位置与递送位置之间操作至少一个阀。
项25:根据项24的多流体注射器系统,其中耦接机构包括叶片,并且其中至少一个阀具有槽,槽成型为接收耦接机构的叶片。
项26:根据项25的多流体注射器系统,其中,当耦接机构的叶片被接收在至少一个阀的槽内时,耦接机构的旋转使得至少一个阀旋转。
项27:根据项25-26的多流体注射器系统,其中耦接机构与至少一个阀自对准,以将耦接机构的叶片接收在至少一个阀的槽内。
项28:根据项25-27中任一项的多流体注射器系统,其中耦接机构被弹簧加载,以随着耦接机构的叶片旋转到与至少一个阀的槽对准时,保持与至少一个阀接触。
项29:根据项25-28中任一项的多流体注射器系统,其中,当耦接机构的叶片与至少一个阀的槽对准时,叶片在有弹力的弹性构件的回复动作下被驱策到槽中。
项30:根据项24-29中任一项的多流体注射器系统,还包括用于操作耦接机构的驱动机构。
项31:根据项24-30中任一项的多流体注射器系统,其中驱动机构旋转耦接机构。
项32:根据项25-31中任一项的多流体注射器系统,其中叶片具有至少一个倾斜表面,其相对于至少一个阀的纵向轴线成角度。
项33:MUDS,包括:多个针筒,每个针筒具有近端和沿着纵向轴线与近端间隔开的远端,以及在针筒内部之内在近端和远端之间可往复地移动的柱塞;歧管,连接到多个针筒中的每一个的远端;与歧管相关联的至少一个阀,至少一个阀在填充位置与递送位置之间可操作,所述填充位置通过歧管填充多个针筒中的至少一个的针筒内部,所述递送位置通过歧管从多个针筒中的至少一个的针筒内部递送流体;至少一个填充管线,当至少一个阀在填充位置中时,至少一个填充管线与多个针筒中的至少一个的内部和针筒内部流体连通;以及当至少一个阀在递送位置中时,与歧管和多个针筒中的至少一个的针筒内部流体连通的至少一个连接端口,其中至少一个阀具有阀头,阀头具有凹陷到阀头中的槽,其中槽成型为接收耦接机构的至少一部分,以当耦接机构接合至少一个阀的槽时,在填充位置与递送位置之间旋转至少一个阀。
根据各个其他方面,本公开提供附接配置,其在至少一个针筒的针筒流体端口与歧管的歧管管道的管道针筒附接端之间:
项34:针筒/歧管配置包括具有锥形远端的至少一个针筒,锥形远端具有针筒流体端口;以及歧管,包括至少一个歧管管道,其中歧管管道与主流体通道和管道针筒附接端流体连接,其中管道针筒附接端与至少一个针筒的针筒流体端口流体连通,其中至少一个歧管管道的管道针筒附接端与至少一个针筒的针筒流体端口流体密封连接。
项35:根据项34的针筒/歧管配置,其中至少一个歧管管道包括配置为与MUDS流体管线流体连通的填充端口、与主流体通道流体连通的排放出口、以及阀接收腔,其中排放出口和填充端口通过阀接收腔中的阀组件与至少一个针筒内部流体连通。
项36:根据项35的针筒/歧管配置,其中阀组件在用流体填充针筒内部的填充位置与从针筒内部递送流体的递送位置之间可操作。
项37:根据项34至36中任一项的针筒/歧管配置,其中至少一个歧管管道的管道针筒附接端通过旋转螺母附接机构与针筒流体端口流体密封连接。
项38:根据项34至36中任一项的针筒/歧管配置,其中至少一个歧管管道的管道针筒附接端包括包覆模制的聚合物鞘,通过与针筒流体端口的内表面溶剂接合,包覆模制的聚合物鞘形成流体密封连接。
项39:根据项34至36中任一项的针筒/歧管配置,其中针筒流体端口包括包覆模制的聚合物鞘,通过与至少一个歧管管道的管道针筒附接端的内表面溶剂接合,包覆模制的聚合物鞘形成流体密封连接。
项40:根据项34至36中任一项的针筒/歧管配置,其中针筒流体端口的内表面和管道针筒附接端的内表面各自包括径向朝内地延伸的锁定凸缘,并且阀组件包括针筒锁定凹槽和歧管锁定凹槽,配置为分别与针筒流体端口和管道针筒附接端的锁定凸缘形成锁定接合。
项41:根据项34至36中任一项的针筒/歧管配置,其中管道针筒附接端的外圆周表面通过UV激活粘合剂接合到针筒流体端口的内圆周表面,并且其中针筒填充端口包括多个横向槽,以允许固化工艺期间的UV激活粘合剂的膨胀。
项42提供:根据项34至36中任一项的针筒/歧管配置,其中针筒流体端口的外圆周表面通过UV激活粘合剂接合到管道针筒附接端的内圆周表面,并且其中管道针筒附接端包括多个横向槽,以允许固化工艺期间的UV激活粘合剂的膨胀。
项43:根据项34至36中任一项的针筒/歧管配置,其中针筒的锥形远端包括多个面向远端的柔性夹,配置为接合管道针筒附接端的外圆周上的径向凸缘。
项44:根据项34至36中任一项的针筒/歧管配置,其中针筒流体端口包含纵向槽,并且管道针筒附接端包括径向凸缘,其中管道针筒附接端在径向凸缘紧邻于纵向槽处插入到针筒流体端口中,并且其中管道针筒附接端与针筒流体端口之间的连接由插入到纵向槽中的C夹保持。
项45:根据项34至36中任一项的针筒/歧管配置,其中针筒流体端口和管道针筒附接端中的一个包括径向凸缘,并且针筒流体端口和管道针筒附接端中的另一个包括接收径向凸缘的互补的径向接收凸缘,并且其中径向凸缘和互补径向接收凸缘由激光焊接连接。
项46:根据项34至36中任一项的针筒/歧管配置,其中针筒流体端口和管道针筒附接端中的一个包括圆周接收槽,圆周接收槽包含能量引导器,并且针筒流体端口和管道针筒附接端中的另一个包括末端部分,末端部分接合圆周接收槽且被接收在圆周接收槽中,并且其中末端部分和圆周接收槽由超声焊接连接。
项47:根据项34至36中任一项的针筒/歧管配置,其中针筒流体端口包括母鲁尔连接器,其与管道针筒附接端上的公鲁尔连接形成流体密封连接,其中针筒流体端口还包括针筒流体端口与管道针筒附接端之间的远端圆周槽,配置为用于接收UV激活粘合剂。
项48:根据项34至36中任一项的针筒/歧管配置,其中针筒流体端口与管道针筒附接端之间的接合限定针筒流体端口的内表面与管道针筒附接端的外表面之间的管状空间,其中管状空间配置为用于接收UV激活粘合剂。
项49:根据项34至36中任一项的针筒/歧管配置,其中针筒流体端口与管道针筒附接端之间的接合限定管道针筒附接端的内表面与针筒流体端口的外表面之间的管状空间,其中管状空间配置为用于接收UV激活粘合剂。
项50:根据项34至36中任一项的针筒/歧管配置,其中针筒流体端口包括母鲁尔连接器,其与管道针筒附接端上的公鲁尔连接形成流体密封连接,其中通过激光点焊将针筒流体端口焊接到管道针筒附接端。
参考附图考虑下面的说明书和所附权利要求,多流体递送系统和用于其的SUDS连接器的这些和其他特征和特性、以及结构及零件的组合的相关元件的操作方法和的功能、制造的经济性将变得更显而易见,全部附图形成本说明书的部分,其中相同附图标记在各附图中指代对应的零件。然而,应明确地理解,附图仅为图示和描述的目的,且不意图为公开的限制的限定。如本说明书和权利要求中所用的,“一”“一个”和“所述”包含复数指代物,除非语境明确地另有指明。
附图说明
图1A是根据本公开的一方面的多流体递送系统的立体图;
图1B是图1A的多流体递送系统的立体图,进入面板处于打开位置;
图2是图1A的多流体递送系统内的各流体路径的示意图;
图3A是当被插入到多流体递送系统上的接收槽中时的MUDS的立体图;
图3B是图3A的MUDS的侧视图;
图4A是安装到图3A的多流体递送系统上的接收槽中的MUDS的立体图;
图4B是图4A的MUDS的侧视图;
图4C是图4A的MUDS的正视图;
图5A是在从图3A的多流体递送系统上的接收槽移除之前的MUDS的侧视图;
图5B是在从图3A的多流体递送系统上的接收槽移除之后的MUDS的侧视图;
图6是在与MUDS上的旋塞阀(stopcock)接合之前的多流体递送系统上的旋塞阀耦接器的立体图;
图7A是在与图6所示的旋塞阀接合之前的旋塞阀耦接器的侧视截面图;
图7B是与图6中所示的旋塞阀初始接合期间的旋塞阀耦接器的侧视截面图;
图7C是在与图6中所示的旋塞阀最终接合期间的旋塞阀耦接器的侧视截面图;
图8A是在将SUDS连接器与多流体递送系统连接之前的连接接口的立体图;
图8B是图8A的连接接口的立体图,示出了与多流体递送系统连接的SUDS连接器;
图9A是根据一方面的SUDS连接器的立体图;
图9B是图9A中所示的SUDS连接器的截面图;
图9C是连接到多流体递送系统的端口的图9A中所示的SUDS连接器的截面图;
图10A是根据本公开的另一方面的MUDS的侧视图;
图10B是图10A中所示的MUDS的俯视图;
图10C是与图10A中所示的MUDS使用的针筒的截面侧视图;
图10D是根据本公开的另一方面的MUDS的侧视立体图;
图11是MUDS的单个针筒的截面侧视图;
图12A是根据本公开的另一方面的与MUDS使用的阀的立体图;
图12B是图12A中所示的阀的侧视图;
图12C是图12B中所示的阀沿着线A-A所截取的截面侧视图;
图13A-C图示了针筒/歧管连接配置的方面;
图14A和14B图示了针筒/歧管连接配置的方面;
图15A和15B图示了针筒/歧管连接配置的方面;
图16A-C图示了针筒/歧管连接配置的方面;
图17A-C图示了针筒/歧管连接配置的方面;
图18A-C图示了针筒/歧管连接配置的方面;
图19A-D图示了针筒/歧管连接配置的方面;
图20A和20B图示了针筒/歧管连接配置的方面;
图21A和21B图示了针筒/歧管连接配置的方面;
图22A和22B图示了针筒/歧管连接配置的方面;
图23A和23B图示了针筒/歧管连接配置的方面;
图24A和24B图示了针筒/歧管连接配置的方面;
图25A是图9C中所示的SUDS连接器的立体图,多流体递送系统和MUDS的部分被切除;
图25B是图25A中所示的SUDS连接器的传感器肋的详细立体图;
图26是根据另一方面的SUDS连接器的立体图;
图27A是图26中所示的SUDS连接器沿着线A-A所截取的放大截面图;
图27B是图26中所示的SUDS连接器沿着线B-B所截取的放大截面图;
图28A-28F是将SUDS连接器连接到MUDS连接器的各阶段的立体图;
图29是根据另一方面的SUDS连接器的立体图;
图30A是根据一方面的MUDS连接器的端口的立体图;
图30B是图30A的MUDS连接器的截面图的示意图;
图30C是根据另一方面具有与之附接的吸收剂垫的MUDS连接器的示意图;
图31A是根据另一方面的SUDS连接器的立体图;
图31B是根据另一方面的MUDS连接器的立体图;
图31C是医用连接器组件的截面图,其中图31A的SUDS连接器插入到图31B的MUDS连接器中;
图32是根据另一方面的SUDS连接器的正视立体图;
图33A是根据另一方面的SUDS连接器的立体图;
图33B是包含图33A的SUDS连接器的医疗连接组件的截面图;
图34A是根据另一方面的SUDS连接器的立体图;
图34B是根据另一方面的SUDS连接器的立体图;
图35A是根据另一方面的SUDS连接器的立体图;
图35B是根据另一方面的SUDS连接器的立体图;
图36A是图35A的SUDS连接器的外部夹的侧视图;
图36B是根据另一方面的医用连接器组件的SUDS的立体图;以及
图37是根据另一方面的多流体流体注射系统的电子控制系统的示意图。
具体实施方式
为了后文中描述的目的,术语“上”、“下”、“右”、“左”、“垂直”、“水平”、“顶部”、“底部”、“横向”、“纵向”及其衍生应涉及如附图中所取向的本公开。当关于MUDS的针筒使用时,术语“近”是指针筒最靠近从针筒递送流体的活塞元件的部分。当关于SUDS连接器使用时,术语“近”是指当SUDS连接器取向为与多流体注射器系统连接时,SUDS连接器最靠近多流体注射器系统的部分。当关于MUDS的针筒使用时,术语“远”是指针筒最靠近递送管口的部分。当关于SUDS连接器使用时,术语“远”是指当SUDS连接器取向为与多流体注射器系统连接时,SUDS连接器最靠近用户的部分。还应理解,附图中所图示的和下面的说明书中所描述的具体的设备和过程仅为本公开的示例性方面。因此,涉及本文公开的方面的具体规格和其他物理特性不应认为是限制性的。
参考附图,其中在其若干视图中,相同的附图标记始终指代相同的部件,本公开总体上涉及多流体医疗注射器/注射系统100(后文中的“流体注射器系统100”),其具有MUDS130(图1B中所示),配置为使用SUDS 190(图8A中所示)向患者递送流体。流体注射器系统100包含如本文中单独描述的多个部件。总体上,流体注射器系统100具有动力注射器管理器或设备以及流体递送套件,其意图与注射器相关联,以在压力下将一种或多种流体从一个或多个多剂量容器递送到患者中,如本文所描述的。同样在本文中详细描述了流体注射器系统100的各种设备、部件和特征以及与之相关联的流体递送套件。
参考图1A,流体注射器系统100包含注射器外壳102,注射器外壳102具有相反的横向侧104、远端或上端106以及近端或下端108。一些方面中,外壳102可以支撑在基部110上,基部110具有一个或多个轮112,以在地面表面上可旋转且可移动地支撑外壳102。一个或多个轮112可以是可锁定的,从而一经设置在所需位置,防止外壳102意外地移动。可以提供至少一个把手114,以便于移动和定位流体注射器系统100。其他方面中,外壳102可以可移除地或不可移除地固定到固定表面,比如地面、天花板、壁或其他结构。外壳102封闭各种机械驱动部件、驱动机械驱动部件所需的电力和动力部件、以及控制部件,比如电子存储器和电子控制设备(后文中的(一个或多个)电子控制设备),用于控制与本文描述的流体注射器系统100相关联的可往复地移动的活塞元件103(图2中所示)的操作。这样的活塞元件103可以经由机电驱动部件(比如由电机、音圈致动器、齿条-小齿轮齿轮驱动器、线性电机等驱动的滚珠螺杆轴)可往复地操作。一些方面中,机械驱动部件、电力和动力部件以及控制部件中的至少一些可以提供在基部110上。
参考图1B且继续参考图1A,流体注射器系统100具有至少一个门116,其封闭机械驱动部件、电力和动力部件、以及控制部件中的至少一些。门116理想地在打开位置(图1B中所示)与关闭位置(图1A中所示)之间可移动。一些方面中,门116可以为可锁定的。
流体注射器系统100还包含至少一个体相(bulk)流体连接器118,以与至少一个体相流体源120连接。一些方面中,可以提供多个体相流体连接器118。例如,如图1A和1B中所示,三个体相流体连接器118可以并排或以其他布置来设置。一些方面中,至少一个体相流体连接器118可以为尖刺,配置为用于可移除地连接到至少一个体相流体源120,比如药瓶、瓶或袋。至少一个体相流体连接器118可以具有与每个新体相流体源120的可重复使用或不可重复使用的接口。至少一个体相流体连接器118可以形成在多患者可丢弃套件上,如本文所描述的。至少一个体相流体源120可以配置为用于接收医疗流体,比如生理盐水、造影剂溶液或其他医疗流体,以递送到流体注射器系统100。外壳102可以具有至少一个支撑构件122,从而一经连接到流体注射器系统100,用于支撑至少一个体相流体源120。
参考图1A,流体注射器系统100包含一个或多个用户界面124,比如图形用户界面(GUI)显示窗口。用户界面124可以显示与涉及流体注射器系统100的流体注射程序有关的信息,比如当前流率、流体压力以及连接到流体注射器系统100的至少一个体相流体源120中剩余的容积,并且可以为触摸屏GUI,其允许操作者输入用于流体注射器系统100的操作的命令和/或数据。尽管用户界面124示出为在注射器外壳102上,这样的用户界面124也可以为远程显示的形式,其有线或无线地连接到外壳102和流体注射器系统100的控制和机械元件。一些方面中,用户界面124可以为平板计算机,其可拆卸地连接到外壳102,并且有线或无线地与外壳102连接通信。此外,流体注射器系统100和/或用户界面124可以包含至少一个控制按键126,用于由流体注射器系统100的服务操作者进行触觉操作。某些方面中,至少一个控制按键可以为键盘的部分,用于由操作员输入命令和/或数据。至少一个控制按键126可以为硬有线或无线地连接到与流体注射器系统100相关联的(一个或多个)电子控制设备,以提供到(一个或多个)电子控制设备的直接输入。至少一个控制按键126还可以为用户界面124(比如触摸屏)的图形部分。在任一布置中,至少一个控制按键126理想地为流体注射器系统100的服务操作员提供某些单独控制特征,比如但不限于:(1)通知多患者可丢弃套件已经装载或卸载;(2)多患者可丢弃套件的锁定/解锁;(3)流体注射器系统100的填充/净化;(4)输入与患者和/或注射程序相关的信息和/或数据,以及(5)启动/停止注射程序。用户界面124和/或与流体注射器系统100相关联的任意电子处理单元可以有线或无线地连接到操作和/或数据储存系统,比如医院网络系统。
参考图1B,流体注射器系统包含MUDS 130,其可移除地连接到流体注射器系统100,以从一个或多个体相流体源120向患者递送一种或多种流体。流体注射器系统100包含至少一个槽或接入端口128,以将SUDS可释放地连接到MUDS 130,如本文所描述的。MUDS130可以包含一个或多个针筒或泵132。一些方面中,针筒132的数目可以对应于体相流体源120的数目。例如,参考图1B,MUDS 130具有并排布置的三个针筒132,使得每个针筒132流体地可连接到体相流体源120中的一个。通过对应的体相流体连接器118和相关联的MUDS流体路径134,每个针筒132可以流体地可连接到体相流体源120中的一个。MUDS流体路径134可以形成为柔性管,柔性管在其连接到体相流体连接器118的末端具有尖刺元件。一些方面中,体相流体连接器118可以直接提供在MUDS 130上。
参考图2-3A,MUDS 130可移除地可连接到流体注射器系统100的外壳102。MUDS130可以包含框架154,以支撑一个或多个针筒132。针筒132可以可移除地或不可移除地连接到框架154。某些方面中,至少一个针筒132可以与框架154共模制,或可替代地粘合或焊接到框架154。参考图3B,每个针筒132具有长形的、实质上圆柱形的针筒主体138,其具有前端或远端140和后端或近端142。针筒柱塞144设置在针筒主体138内,并且由于与流体注射器系统100相关联的活塞元件的运动,在针筒主体138内可往复地移动。针筒主体138的远端140是大体上锥形形状的,并且渐缩到顶点或锥点145,顶点或锥点145适配为与流体注射器系统100中限定的凹陷中形成的对应的顶点曲面相接,如本文所描述的。针筒顶点或锥点145沿着针筒主体138的中心纵向轴线L定位。
继续参考图3B,每个针筒132可以具有填充端口147,其与MUDS流体路径134流体连通,以使用来自体相流体源120(图2中所示)的流体填充针筒内部139。每个针筒132还可以在顶点或锥点145的末端处具有排放出口或管道146。每个针筒132的排放出口146与歧管148流体连通。一些方面中,歧管148可以流体地连接多个针筒132。某些方面中,歧管148还可以为针筒132提供支撑,使得针筒132可以作为单个、单一结构被处理。一些方面中,歧管148支撑每个针筒132的远端140,而框架154支撑每个针筒132的近端142。一些方面中,歧管148的至少一部分可以与至少一个针筒132一体地形成。其他方面中,歧管148可以与多个针筒132分开地形成,并且包含对应于多个针筒132中的每一个的多个管道148a,其中单独管道148a可以附接或粘合到多个针筒132中的每一个的单独出口端口146,例如通过适当的粘合剂或焊接。针筒132可以布置为并排取向,或保持针筒132的相对位置的任意其他取向。
参考图10A-10C,图示了根据另一方面的MUDS 130。MUDS 130可以包含并排的或其他布置的多个针筒132,每个针筒132流体地可连接到体相流体源120(图2中所示)中的一个。每个针筒132可以与歧管148流体连通。歧管148可以包含在针筒132的排放出口146之间延伸的板状结构,使得歧管148一体地连接针筒132。歧管148可以具有与每个针筒132流体连通的流体通路149。流体通路149可以与一个或多个流体出口管线152(图2中所示)流体连通。歧管148的第一部分148a可以比如通过模塑、粘合剂方式或焊接与每个针筒132一体地形成,而第二部分148b(图11中所示的)可以永久地或非永久地连接到第一部分148a。一些方面中,歧管148的第一部分148a可以通过焊接、粘合剂、一个或多个特征或任意其他连接方式连接到第二部分148b。第一部分148a和第二部分148b的组合可以形成歧管内的流体路径,其将多个针筒132中的每一个的排放端口146与一个或多个流体出口管线152流体地连接。第一部分148a和第二部分148b中的至少一个可以具有通道151,通道151绕着围绕排放出口146的歧管148的圆周延伸。通道151可以配置为用于接收垫圈153(图11中所示的),以密封第一部分148a与第二部分148b之间的接口。参考图10B-10C,可以在每个针筒132的顶点或锥点145的末端处提供阀接收腔155。阀接收腔155可以在与每个针筒132(图10C中所示)的纵向轴线L对准的方向上延伸到针筒内部139中。一些方面中,阀接收腔155与针筒内部139、填充端口147以及排放出口146流体连通。阀接收腔155配置为用于接收阀136(图11中所示的)。如本文所描述的,阀136的至少一部分可以围绕纵向轴线L且在阀接收腔155内可旋转。阀136可以在用流体填充针筒内部139的填充位置与从针筒内部139递送流体的递送位置之间可操作。一些方面中,阀136可以在第一位置与第二位置之间可旋转,在第一位置,填充端口147与针筒内部139流体连通而排放出口146与针筒内部139流体隔离,在第二位置,排放出口146与针筒内部139流体连通而填充端口147与针筒内部139流体隔离。阀136可以具有第三位置,在第三位置,针筒内部139与填充端口147和排放出口146两者隔离。在第一位置中,阀136可以配置为通过MUDS流体路径134用来自体相流体源120的流体填充针筒内部139,同时防止流体递送到歧管148。在第二位置中,阀136可以配置为通过排放出口146将流体从针筒内部139递送到歧管148,同时防止通过填充端口147递送流体。阀136还可以配置为防止通过填充端口147和排放出口146的流体流动,使得流体无法递送到针筒内部139中或从之递送。一些方面中,阀136可以是可旋转的,以部分地打开或部分地关闭排放出口146和/或填充端口147。各方面中,每个针筒132上的阀136可以彼此独立地控制,例如,使得各种医疗流体可以递送到一个或多个针筒132中,和/或,同时地或依次地从一个或多个其他针筒132递送出。多个针筒132的阀136可以例如通过与流体注射器系统100相关联的(一个或多个)电子控制设备控制。
参考图10D,图示了根据另一方面的MUDS 130。MUDS 130可以包含并排或其他布置的多个针筒132,每个针筒132流体地可连接到体相流体源120(图2中所示)中的一个。MUDS130可以包含框架154,以支撑一个或多个针筒132。针筒132可以可移除地或不可移除地连接到框架154。一些方面中,通过体相流体连接器118和MUDS流体路径134,每个针筒可以流体地可连接到体相流体源120中的一个。每个针筒132的顶点或锥点145可以具有排放出口146、填充端口147以及阀接收腔155。阀接收腔155可以在实质上平行于每个针筒132的纵向轴线L的方向上延伸到针筒内部中(参见例如,图11)。排放出口146和填充端口147可以在实质上垂直于每个针筒132的纵向轴线L的方向上朝向针筒内部延伸。排放出口146和填充端口147可以绕顶点或锥点145的外圆周彼此相反布置。一些方面中,阀接收腔155与针筒内部、填充端口147以及排放出口146流体连通。
继续参考图10D,每个针筒132的排放出口146可以连接到歧管148。每个针筒132可以分开地形成且独立地可连接到歧管148。歧管148可以为管状结构,其具有一个或多个管道148a,以连接到针筒132的排放出口146。一些方面中,管道148a可以可移除地或不可移除地连接到排放出口146。例如,每个管道148a可以粘合地连接、激光或超声振动焊接、或由一个或多个机械紧固件永久地且不可移除地紧固到相应的排放出口146。可替代地,每个管道148a可以可移除地连接到相应的排放出口146,例如,过盈配合、一个或多个夹,或其他机械连接机构。歧管148可以具有主流体通道148b,主流体通道148b通过相应的管道148a与每个针筒132流体连通。一些方面中,一个或多个管道148a与主流体通道148b一体地形成。主流体通道148b的一端可以与一个或多个流体出口管线152流体连通,以将来自针筒132的流体递送给患者,如本文所描述的。
阀接收腔155配置为用于接收阀136。如本文所描述的,阀136的至少一部分可以围绕纵向轴线L且在阀接收腔155内可旋转。阀136可以在用流体填充针筒内部的填充位置与从针筒内部递送流体的递送位置之间可操作。一些方面中,阀136可以在第一位置与第二位置之间可旋转,在第一位置,填充端口147与针筒内部流体连通而排放出口146与针筒内部流体隔离,在第二位置,排放出口146与针筒内部流体连通而填充端口147与针筒内部流体隔离。在第一位置中,阀136可以配置为通过MUDS流体路径134使用来自体相流体源120的流体填充针筒内部,同时防止流体递送到歧管148。在第二位置中,阀136可以配置为通过排放出口146将来自针筒内部的流体递送到歧管148,同时防止通过填充端口147递送流体。阀136还可以配置为用于防止通过填充端口147和排放出口146的流体流动,使得流体无法被递送到针筒内部中或从之递送。一些方面中,阀136可以为可旋转的,以部分地打开或部分地关闭排放出口146和/或填充端口147。各方面中,每个针筒132上的阀136可以彼此独立地控制,使得流体可以被递送到一个或多个针筒132中,而同时地或依次地从一个或多个其他针筒132递送出。
进一步参考图2,MUDS 130可移除地可连接到流体注射器系统100的外壳102。如本领域普通技术人员将理解的,可能期望由透明医用级塑料构建MUDS 130的至少一部分,以便于视觉验证已经与流体注射器系统100建立流体连接。还期望视觉验证,以确认各种流体连接内不存在空气泡。可替代地,MUDS 130的至少一部分和/或门116可以包含窗(未示出),用于各种部件之间的连接的可视化。还可以提供各种光学传感器(未示出),以检测和验证连接。此外,可以提供各种发光元件(未示出),比如发光二极管(LED),以激发一个或多个光学传感器并指示各部件之间已经建立适当连接。
继续参考图2,提供了流体注射器系统100的各种流体路径的示意图。MUDS 130可以包含一个或多个阀136,比如旋塞阀,以控制哪种医疗流体或医疗流体的组合被从多剂量体相流体源120抽取和/或通过每个针筒132递送到患者。一些方面中,可以在多个针筒132的远端140上或歧管148上提供一个或多个阀136。歧管148可以经由阀136和/或针筒132与MUDS流体路径134的第一端流体连通,MUDS流体路径134将每个针筒132连接到对应的体相流体源120。MUDS流体路径134的相反的第二端可以连接到相应的体相流体连接器118,体相流体连接器118配置为用于与体相流体源120流体地连接。根据一个或多个阀136的位置,流体可以被抽入到一个或多个针筒132中,或可以被从一个或多个针筒132递送。在第一位置中,比如在针筒132的填充期间,定向一个或多个阀136,使得流体从体相流体源120通过MUDS流体路径134流入期望的针筒132中。在填充程序期间,设置一个或多个阀136,使得通过一个或多个流体出口管线152或歧管148的流体流动被阻塞。在第二位置中,比如在流体递送程序期间,来自一个或多个针筒132的流体通过一个或多个流体出口管线152或针筒阀出口端口被递送到歧管148。在递送程序期间,设置一个或多个阀136,使得通过MUDS流体路径134的流体流动被阻塞。一个或多个阀136、MUDS流体路径134、和/或流体出口管线152可以集成到歧管148中。通过手动或自动操纵,可以将一个或多个阀136选择性设置到第一或第二位置。例如,操作员可以将一个或多个阀136设置到期望的位置,以填充或递送流体。另一方面中,流体注射器系统100的至少一部分是可操作的,以将一个或多个阀136自动地设置到期望的位置,从而基于操作员的输入来填充或递送流体,如本文所描述的。阀主体结构的适当示例在国际申请No.PCT/US2012/056355和美国申请公开No.2014/0228762中示出,其均提交于2012年9月20日,其公开通过此引用整合。
具体参考图3B,MUDS 130还包含框架154,框架154接收至少一个针筒132的近端142的至少一部分。一些方面中,框架154可以成型为接收每个针筒132的近端142的至少一部分。一些方面中,流体出口管线152可以连接到框架154。在一些方面中,框架154限定了用于将SUDS连接到MUDS 130的连接端口192的至少一部分。框架154可以具有把手,以在插入到流体注射器系统100中和从之移除期间抓握MUDS 130。某些方面中,连接端口192可以形成为框架154的部分或粘合/焊接到框架154,以形成单个MUDS单元。
参考图2,一些方面中,流体出口管线152还可以连接到流体注射器系统100上的废弃物储器156。废弃物储器156理想地与针筒132分开,以防止污染。一些方面中,废弃物储器156配置为接收例如预备操作期间从针筒132排出的废弃物流体。废弃物储器156可以从外壳102可移除,以丢弃废弃物储器156的内容物。其他方面中,废弃物储器156可以具有排液端口(未示出),以在不从外壳102移除废弃物储器156的情况下排空废弃物储器156的内容物。一些方面中,废弃物储器156提供为与MUDS 130分开的部件。
考虑流体注射器系统100和MUDS 130的前面的描述,现在将参考图3A-5B描述在外壳102上将MUDS 130示例性地装载和卸载到接收空间158中(图3A中所示)。下面的讨论中,假设MUDS 130可以连接到与流体注射器系统100的连接或从之移除,以与单个或多个患者使用。初始参考图3A,接收空间158具有底部板160,底部板160通过后侧壁164与顶部板162分隔。底部板160具有多个开口166,流体注射器系统100的活塞元件103延伸通过多个开口166,以接合MUDS 130的相应的柱塞144。至少一个底部导轨168形成在底部板160上,以随着MUDS 130装载到流体注射器系统100中,而引导MUDS 130的框架154。一些方面中,底部导轨168可以配置为相对于底部板160升高的一对壁,且在朝向后侧壁164的插入方向上变窄。在插入期间,底部导轨168限定引导表面,其定位MUDS 130的框架154,且将框架154朝向接收空间158的后侧壁164引导。以此方式,即使当MUDS 130初始地与接收空间158未对准时,MUDS 130也可以对准到接收空间158中。
参考图3B且继续参考图3A,顶部板162配置为接收至少一个针筒132的远端140。顶部板162具有一个或多个针筒槽170(图3A中所示),其成型为接收针筒132的远端140的至少一部分。一些方面中,当MUDS 130插入到接收空间158中时,顶部板162的针筒槽170可以设置在至少一个针筒132的远端140与歧管148之间。顶部板162可以绕枢转点P1可旋转,如图3B所示,或其可以在相对于MUDS 130的垂直方向上可移动。在第一位置中,比如在将MUDS130装载到接收空间158中期间,顶部板162可以升高,使得至少一个针筒132的顶点或锥点145离开顶部板162的下表面。一些方面中,每当MUDS 130被从接收空间158移除时(比如通过偏置机构),顶部板162可以默认为第一位置。另一方面中,随着至少一个针筒132的顶点或锥点145接合至少一个针筒槽170,可以将顶部板162驱策到第一位置。
随着MUDS 130接合后侧壁164,比如图4A中所示,可以通过将顶部板162移动到第二位置,而将MUDS 130锁定在接收空间158中。在第二位置中,降低顶部板162,使得至少一个针筒132的顶点或锥点145接合顶部板162的下表面。一些方面中,可以通过偏置机构(未示出)将顶部板162驱策到第二位置。另一方面中,可以通过在图4A-4B中所示的箭头A的方向上枢转顶部板162,将顶部板162手动移动到第二位置。顶部板162可以相对于MUDS 130锁定,以通过闩锁172防止MUDS 130从接收空间158移除。闩锁172可以为可操作的,以防止顶部板162绕枢转点P1旋转。闩锁172可以为越过中心、弹簧加载的闩锁,其在图4B所示的箭头B的方向上绕枢转点P2可枢转。参考图4C,当MUDS 130锁定在接收空间158内时,顶部板162的下表面接合至少一个针筒132的顶点或锥点145。在锁定位置中,每个针筒132的纵向轴线L与每个针筒槽170的中心对准。当顶部板162在锁定位置中时,通过顶部板162的下表面与至少一个针筒132的顶点或锥点145的接合防止MUDS 130从接收空间158移除。一经锁定,顶部板162在注射程序期间保持针筒132不轴向移动。
参考图5A-5B,通过从至少一个针筒132的顶点或锥点或锥形部分145解锁顶部板162,将MUDS 130从接收空间158移除。下面的讨论中,假设MUDS 130可以从与流体注射器系统100的连接被移除,且作为医疗废弃物丢弃。一些方面中,通过将闩锁172绕枢转点P2在图5A所示的箭头C的方向上的枢转运动而将闩锁172解闩锁,来解锁顶部板162。随着闩锁172被解闩锁,顶部板162相对于MUDS 130在图5B中所示的箭头D的方向上朝上枢转。通过解锁顶部板162,顶部板162可以相对于MUDS 130移动(即,枢转或升高),以允许至少一个针筒132的顶点或锥点或锥形部分145离开顶部板162的针筒槽170(图3A中所示)。则可以通过将MUDS 130移动离开后侧壁164(图3A中所示),在与插入方向相反的方向上拔取MUDS 130。
参考图6,一些方面中,MUDS 130可以具有一个或多个可旋转阀136,其控制通过歧管148的流体流动。一个或多个阀136可以在各种位置之间可旋转,以实现流体填充或递送。一些方面中,可以提供耦接机构174,以旋转一个或多个阀136且从而控制MUDS 130的布置,用于流体填充或递送。耦接机构174可以为可旋转耦接器176的形式,其接合至少一个可旋转阀136。一些方面中,可旋转耦接器176具有叶片178,叶片178配置为与至少一个可旋转阀136上的槽180接合。可旋转耦接器176可以使用流体注射器系统100上提供的驱动机构(未示出)而可旋转,从而旋转耦接器176上至360度直到叶片178接合槽180。耦接机构174可以包含传感器(未示出),其感测叶片178何时接合槽180且指示耦接机构174停止旋转耦接器176。根据各种方面,不论槽180的初始取向,耦接机构174能够接合且耦接到阀136。因此,可以补偿阀136的任何旋转运动(例如制造、运输或MUDS 130的插入期间)。可旋转耦接器176的叶片178一经接合至少一个可旋转阀136上的槽180,可旋转耦接器176的旋转导致可旋转阀136的对应的旋转。以此方式,一个或多个阀136的布置可以在填充一个或多个针筒132(图3A中所示)的位置与从一个或多个针筒132递送流体的位置之间切换。
参考图12A-12C,阀136具有阀主体250,配置为用于可旋转地接收在阀接收腔155(图11中所示的)的至少一部分内。一些方面中,阀136配置为在实质上垂直的取向中接收在阀接收腔155内,使得阀136可以与注射器上的耦接机构174相接。阀主体250具有连接到阀头254的阀杆252。阀杆252可以成型为接收在阀接收腔155的至少一部分内。阀头254可以与阀杆252一体地形成,比如通过模塑。一些方面中,阀头254与阀杆252分开地形成,且可移除地或不可移除地连接到阀杆252。阀杆252和阀头254可以由相同或不同的材料形成。一些方面中,阀杆252形成为实质上圆柱形构件,阀头254与阀杆252一体地形成,使得阀头254相对于阀杆252径向朝外延伸。各方面中,阀头254可以为圆形、正方形、矩形或成型为具有任意规则或不规则的几何形状,其具有一个或多个线性或曲线边缘。阀杆252和阀头254可以相对于阀136的纵向轴线256对准或偏移。
阀136的至少一部分可以由弹性材料制成,以提供对阀接收腔155的侧壁的密封。一些方面中,阀136的至少一部分可以由生物相容的、非致热原性(non-pyrogenic)、不含乳胶的和/或不含DEHP的材料制成。其他方面中,阀136可以由与各种医疗流体(包含但不限于,各种造影剂溶液和生理盐水溶液)兼容的材料制成。其他方面中,阀136可以配置为用于各种灭菌技术,包含但不限于,电子束灭菌、伽马灭菌和/或环氧乙烷灭菌。其他方面中,阀136可以配置为在预定持续时间上使用,比如24小时的时间,之后针筒132连同阀136必须被丢弃。一些方面中,阀136可以额定为大于350psi的最大操作压力。其他方面中,旋转阀136所需的致动扭矩可以小于3N-m,失效扭矩(failure torque)大于2.5倍致动扭矩。其他方面中,阀136可以配置为用于以60rpm或更快速地旋转。其他方面中,阀136的内部流体损失可以小于总要求容积的0.5%。其他方面中,对于200ml针筒132,阀136可以具有小于0.1ml的可允许泄露。
参考图12A,阀头254具有槽180,其形成为延伸到阀头254中的凹陷。一些方面中,阀头254可以具有多个槽。槽180可以延伸跨过阀头254的上表面的至少一部分。一些方面中,槽180可以与阀136的纵向轴线256对准,使得槽180在相对于纵向轴线256的径向方向上延伸。其他方面中,槽180可以相对于阀136的纵向轴线256偏移。槽180沿着其长度可以具有均匀或不均匀的宽度。槽180可以被一个或多个凹陷258围绕,凹陷258具有在槽180与阀头254的外圆周262之间延伸的一个或多个肋260。槽180可以沿着槽180的长度以均匀或不均匀的深度延伸到阀头254中。槽180可以具有平坦底部,或其可以成角度,以在阀头254中形成v形。
参考图12C,阀杆252理想地为中空的,侧壁264限定阀杆252的外形。中空阀杆252具有内部268,内部268具有开放底端266。阀杆252具有第一侧开口270,第一侧开口270在从底端266偏移的位置处延伸穿过侧壁264。第一侧开口270与阀杆252的内部268流体连通。第一侧开口270可以在相对于阀136的纵向轴线256垂直或倾斜的方向上延伸穿过侧壁264。一些方面中,可以提供多个第一侧开口270。在这样的方面中,多个第一侧开口270可以绕阀杆252的外圆周圆周向地延伸和/或沿着阀136的纵向轴线256轴向地延伸。
参考图12C,插入件272可以接收在阀杆252的内部268之内。一些方面中,插入件272可以与阀136一体地形成,比如通过将阀136与插入件272共模制。插入件272的至少一部分可以延伸到阀头254上形成的凹陷258中,以防止插入件272相对于阀杆252的旋转。插入件272具有中空主体,中空主体具有围绕内部275的圆周向侧壁274,内部275具有开放底端276。至少一个第二侧开口278延伸穿过插入件272的中空主体的侧壁274。第二侧开口278与阀杆252的第一侧开口270对准,使得第一侧开口270和第二侧开口278彼此流体连通。以此方式,第一侧开口270通过L形流体路径与插入件272的内部275流体连通。
在与流体注射器系统100连接之前,一个或多个阀136可能相对于流体注射器系统100上的耦接机构174未对准。为了对准一个或多个阀136以与耦接机构174旋转,可旋转耦接器176可旋转到与至少一个阀136自对准。随着MUDS 130(图3A中所示)装载到流体注射器系统100的接收空间158中,阀136的至少一部分(比如其外侧壁182的部分(图7A所示))接合可旋转耦接器176的至少一部分。参考图7A,可旋转耦接器176的叶片178可以具有倾斜表面184,其相对于阀136的外侧壁182成角度。一经与倾斜表面184接触,随着MUDS 130移动到接收空间158中,阀136的外侧壁182沿着倾斜表面184滑动。阀侧壁182可以在阀侧壁182的远端周界上包含斜角的、倒角的或圆角的边缘183,其可以促进倾斜表面184与阀136之间的接合。这样的滑动移动导致可旋转耦接器176在图7A中的箭头E的方向上垂直地移动。一些方面中,可旋转耦接器176可以弹簧加载,使得当叶片178在箭头E的方向上移动时,例如当叶片178与槽180未正确对准时,回复力储存在有弹力的弹性构件188中。如图7C中所示,槽180可以在一端上具有的唇181,其将叶片178的取向限制为插入到槽180中的单个取向,例如当叶片178的倾斜表面184相邻于唇181时。当MUDS 130完全插入到接收空间中时,可旋转耦接器176的叶片178设置在阀136的上表面186上。为了将阀136与可旋转耦接器176对准,相对于阀136旋转可旋转耦接器176,直到叶片178与槽180对准。一经对准,叶片178降低到槽180中。然后可旋转耦接器176可以在有弹力的弹性构件188的回复动作下被驱策到槽180中。槽180可以具有侧壁,其从上表面186开始变窄,以促进叶片178插入到槽180中。叶片178一经插入到槽180中,可旋转耦接器176可以调整阀136的取向,用于流体填充或递送,如本文所描述的。由于每个阀136与每个可旋转耦接器176之间仅存在一个正确取向,操作注射器的系统可以确定每个阀136的取向且确定每个可旋转耦接器176的正确旋转,其为从MUDS 130的多个针筒132中的每一个填充或递送流体所需。
已经总体上描述了流体注射器系统100和MUDS 130的部件,现在将描述SUDS 190的结构和使用方法及其与MUDS 130的相互作用。
参考图8A和8B,流体注射器系统100具有连接端口192,其配置为与SUDS 190的至少一部分形成可释放的流体连接。一些方面中,连接端口192可以形成在MUDS 130上。连接端口192可以由流体注射器系统100的外壳102的至少一部分屏蔽。例如,通过防止或限制用户或患者触摸和污染接触要注射给患者的流体的连接端口192的部分,使得连接端口192凹陷在外壳102内可以保持连接端口192的无菌性。一些方面中,连接端口192凹陷在形成于流体注射器系统100的外壳102上的开口194内,或者连接端口192可以具有围绕连接端口192的至少一部分的屏蔽结构(未示出)。其他方面中,连接端口192可以直接形成在外壳102上且通过流体路径(未示出)连接到MUDS 130。如本文所描述的,SUDS 190可以连接到连接端口192,其形成在MUDS 130的至少一部分和/或外壳102上。理想地,SUDS 190与连接端口192之间的连接为可释放连接,以允许SUDS 190与连接端口192(图8A)选择性地断开和连接到连接端口192(图8B)。一些方面中,SUDS 190可以与连接端口192断开且在每个流体递送程序之后丢弃,并且可以将新的SUDS 190连接到连接端口192,用于后续的流体递送程序。
继续参考图8A和8B,可以与连接端口192分开地提供废弃物入口端口196。废弃物入口端口196与废弃物储器156流体连通。一些方面中,与SUDS 190分开地提供废弃物储器156,使得来自废弃物入口端口196的流体可以递送到废弃物储器156。SUDS 190的至少一部分可以可释放地连接到废弃物入口端口196或与之相关联,以在例如从SUDS 190排出空气的预备操作期间将废弃物流体引入到废弃物储器156中。废弃物储器156可以具有带标记200(比如刻度标记)观察窗198,其指示废弃物储器156的填充液位。
参考图9A,SUDS 190具有流体入口端口202,其配置为与连接端口192(图8A中所示)可释放地连接。流体入口端口202接收从流体注射器系统100递送的流体。流体入口端口202理想地为中空管状结构,如图9B所示。SUDS 190还具有废弃物出口端口204,其配置为与废弃物入口端口196(图8A中所示)可释放地连接或与之相关联。在例如SUDS 190的预备操作期间,废弃物出口端口204接收废弃物流体,且将这样的废弃物流体递送到废弃物储器156。废弃物出口端口204理想地为中空管状结构,如图9B所示。废弃物出口端口204可以连接到、插入到或位于废弃物入口端口202中,使得废弃物流体可以流动通过废弃物入口端口202且继续到废弃物储器156中。流体入口端口202和废弃物出口端口204可以由间隔体206彼此间隔开。一些方面中,间隔体206的尺寸设定为为将流体入口端口202和废弃物出口端口204设置为分别与连接端口192和废弃物入口端口196对准。注意到,图9A中将SUDS 190示出为从包装(未示出)移除之后的状态。使用之前,SUDS 190理想地包装在预灭菌、密封包装中,其保护SUDS 190免受空气或表面传播的污染物的污染。可替代地,密封包装和SUDS 190可以在包装之后灭菌。
SUDS 190理想地具有不对称结构,使得用户仅能在一个取向上将SUDS 190附接到MUDS 130。以此方式,防止用户将流体入口端口202附接到废弃物入口端口196。一些方面中,可以在SUDS 190的至少一部分上提供鳍片207,以防止SUDS 190错误插入到连接端口192中。某些方面中,鳍片207可以形成在间隔体206上,靠近废弃物出口端口204。以此方式,鳍片207可以干涉SUDS 190不正确插入到连接端口192中。除鳍片207之外的结构和形状可以用来防止SUDS 190错误插入到连接端口192中。
一些方面中,管路208可以在其近端210处连接到流体入口端口202。管路208配置为递送从流体入口端口202接收的流体。管路208的远端212可以具有连接器214,其配置为与废弃物出口端口204或连接到患者(未示出)的流体路径连接。管路208可以由柔性材料制成,比如医用级塑料材料,其允许管路208盘绕。连接器214可以为鲁尔锁定连接器(公鲁尔锁定连接器或母鲁尔锁定连接器,根据期望的应用)或其他医用连接器配置。一些方面中,连接器214可以具有单向阀,以防止流体的回流。可替代地,单向阀可以位于SUDS 190中的流体入口端口202与连接器214之间的其他位置。
继续参考图9A,SUDS 190可以具有锁定片216,其配置为用于将SUDS 190与流体注射器系统100选择性地锁定,这取决于锁定片216与流体注射器系统100的至少一部分的接合。一些方面中,锁定片216可以为柔性片,其通过偏转锁定片216的至少一部分,在接合位置与脱离位置之间可偏转。锁定片216可以具有按压表面218,当其被按压时,使得锁定片216从接合位置偏转到脱离位置,用于从流体注射器系统100插入和移除SUDS 190。一些方面中,锁定片216可以配置为与MUDS 130(图9C中所示)上的接收槽217可释放地锁定接合。
参考图9B,SUDS 190可以具有第一环状裙224,其绕流体入口端口202的近端226周向地延伸,以及第二环状裙220,其绕流体入口端口202的远端222周向地延伸。第一环状裙224和第二环状裙220围绕流体入口端口202,以防止无意接触和污染。第一环状裙224可以具有延伸穿过其侧壁的一个或多个凹陷228(图9A中所示)。一个或多个凹陷228可以提供与流体注射器系统100上的对应的锁定元件(未示出)的锁定接口。第二环状裙220可以具有至少一个凹部230(图9A中所示),以促进SUDS 190的抓握和持握。一些方面中,第二环状裙220可以具有纹理的表面,其具有一个或多个肋232(图9A中所示),以促进SUDS 190的抓握和持握。
继续参考图9B,可以绕流体入口端口202的近端226提供至少一个环状密封234。至少一个环状密封234可以密封流体入口端口202,以防止流体通过SUDS 190泄露。当SUDS190与MUDS 130彼此流体连接时,至少一个环状密封234可以提供SUDS 190与MUDS 130之间的流体密封,以允许流体在没有泄露的情况下从MUDS 130流动到SUDS 190。可以在流体入口端口202的内腔内提供单向阀236,以防止流体在逆向方向上从SUDS 190流到MUDS 130中。
参考图9C,图9A中所示的SUDS 190示出为连接到流体注射器系统100。尽管图9C将连接端口192图示为形成在MUDS 130上,其他方面中,连接端口192可以形成在外壳102(图1中所示)的一部分上。SUDS 190的流体入口端口202连接到连接端口192,以建立图9C中箭头F所示的方向上的流体路径。通过流体入口端口202的流体流动通过单向阀236且进入管路208中。可能从流体入口端口202与连接端口192之间的接口滴落的任何流体被收集在废弃物储器156中。废弃物储器156可以成型为收集当从MUDS 130移除时可能从SUDS 190滴落的任何流体。此外,当SUDS 190连接到连接端口192时,废弃物出口端口204的出口设置在废弃物入口端口196内,使得来自管路208的废弃物流体可以排放到废弃物储器156中。间隔体206可以限定插入停止表面,以限定SUDS 190插入到连接端口192中的深度。
图13-24图示了一个或多个针筒132的顶点或锥点或远端锥形端145的末端与包含至少一个歧管管道的歧管148之间的各种连接配置,其中歧管管道148a与主流体通道148b和管道针筒附接端流体连接,其中管道针筒附接端与至少一个针筒132的针筒流体端口流体连通。根据这些方面,至少一个歧管管道148a包括填充端口147,填充端口147配置为与以下三个流体连通:MUDS流体管线134、与主流体通道148b流体连通的排放出口146、以及阀接收腔155,其中排放出口146和填充端口147通过阀接收腔155中的阀组件272与至少一个针筒132的内部139流体连通。
参考图13A-C,示出了包含旋转螺母连接的针筒/歧管连接配置的一方面。至少一个针筒132的远端锥形端1346包含公鲁尔尖和圆周向凹槽1390。圆周向凹槽1390配置为接收包含内螺纹1382的螺纹旋转螺母1380的朝内径向凸缘1385。歧管管道1370的管道针筒附接端1372包含母鲁尔尖端,配置为与远端锥形端1346的公鲁尔尖端流体密封连接。内螺纹1382与歧管管道1370的管道针筒附接端1372上的互补螺纹1375螺纹地(threadibly)相互作用,以将歧管管道1370与远端锥形端1346连接。
参考图14A-B,示出了包含具有溶剂接合的包覆模制的歧管连接的针筒/歧管连接配置的一方面。至少一个歧管管道1470的管道针筒附接端1472包括包覆模制的聚合物鞘1476,其通过管道针筒附接端1472的外表面与针筒流体端口1446的内表面之间的溶剂接合形成流体密封连接。某些方面中,至少一个针筒和/或歧管管道1470可以由诸如聚碳酸酯的第一聚合物材料制成,并且包覆模制的聚合物鞘1476可以由诸如聚氨酯的第二聚合物材料制成,其可以在制造期间包覆模制在管道针筒附接端1472上。然后可以用溶剂处理聚合物鞘1476,比如但不限于环己酮、甲基乙基酮或其他适当的溶剂,其至少部分地溶解第二聚合物材料,一经设定,就形成两个表面之间的溶剂接合。根据图15A和15B中图示的另一方面,针筒流体端口1546可以包括包覆模制的聚合物鞘1576,其已经包覆模制在针筒流体端口1546的外表面上,然后其形成流体密封连接,且与至少一个歧管管道1570的管道针筒附接端1572的内表面密封。
参考图16A-C,示出了针筒/歧管连接配置的一方面,其包含使用阀组件136的杆的杆锁定配置以连接针筒和歧管。根据此方面,针筒流体端口1646的内表面1649包括径向朝内延伸的锁定凸缘1685,并且管道针筒附接端1672的内表面包括径向朝内延伸的锁定凸缘1673。阀组件136包括针筒锁定凹槽1695和歧管锁定凹槽1690,其配置为与针筒流体端口1646和管道针筒附接端1672的锁定凸缘1685、1673形成锁定接合。某些方面还可以包含阀组件与针筒流体端口1646和管道针筒附接端1672中的一者或两者之间的一个或多个O形环。
参考图17A-C,示出了包含UV激活粘合剂的针筒/歧管连接配置的一方面。根据此方面,通过UV激活粘合剂将管道针筒附接端1772的外圆周表面接合到针筒流体端口1746的内圆周表面。为容纳固化期间UV激活粘合剂的潜在的膨胀,针筒填充端口1746可以包括多个横向槽1790,以允许固化工艺期间UV激活粘合剂的膨胀,在这种情况下,过量的粘合剂可以膨胀通过横向槽1790。另一方面(未示出),管道针筒附接端1772可以包括多个横向槽,以允许固化工艺期间UV激活粘合剂的膨胀,其中过量的粘合剂可以膨胀通过横向槽。
参考图18A-C,示出了包含多个柔性夹元件的针筒/歧管连接配置的一方面。根据一方面,锥形远端145可以包括多个面向远端的柔性夹1890,配置为接合歧管管道1870的管道针筒附接端1872的外圆周上的径向凸缘1875。针筒流体端口1846可以包含公鲁尔尖端,其可密封地接合管道针筒附接端1872上的母鲁尔尖端。另一方面(未示出)中,柔性夹可以位于管道针筒附接端1872上,并且近端地地突起,以接合针筒流体端口1846上的对应的凸缘。
参考图19A-D,示出了包含C夹锁定特征的针筒/歧管连接配置的一方面。根据此方面,针筒流体端口1946包含纵向槽1995,并且管道针筒附接端1972包括径向凸缘1975。管道针筒附接端1972插入到针筒流体端口1946中,至径向凸缘1975紧邻于纵向槽1995的点处。管道针筒附接端1972与针筒流体端口1746之间的连接由插入到远端紧挨径向凸缘的纵向槽1995中的C夹1990保持。管道针筒附接端1972还可以包括一个或多个O形环1999,配置为在管道针筒附接端1972与针筒流体端口1946之间形成流体密封。
参考图20A-B,示出了包含激光焊接特征的针筒/歧管连接配置的一方面。根据此方面,针筒流体端口2046与管道针筒附接端2072中的一个包括径向凸缘2085,径向凸缘2085具有配置为用于激光焊接的表面,并且针筒流体端口2046和管道针筒附接端2072中的另一个包括互补的径向接收凸缘2073,互补的径向接收凸缘2073接收径向凸缘2085且具有配置为用于激光焊接的互补表面。径向凸缘2085和互补的径向接收凸缘2073由其之间的激光焊接2086连接。
参考图21A-B,示出了包含超声焊接特征的针筒/歧管连接配置的一方面。根据此方面,针筒流体端口2146和管道针筒附接端2172中的一个包括圆周接收槽2185,圆周接收槽2185包含能量引导器2186,并且针筒流体端口2146和管道针筒附接端2172中的另一个包括末端部分2175,末端部分2175接合圆周接收槽2185且被接收在之中。通过暴露于超声振动,末端部分2175和圆周接收槽2185由其之间的超声焊接连接,超声振动可以由能量引导器2186引导。
参考图22A-B,示出了包含具有UV粘合接合的鲁尔密封的针筒/歧管连接配置的一方面。根据此方面,针筒流体端口2246可以包括母鲁尔连接器,其与管道针筒附接端2272上的公鲁尔连接器形成液体密封连接。当组装鲁尔连接时,远端圆周槽2080形成在针筒流体端口2246与管道针筒附接端2272之间。远端圆周槽2080配置为用于接收UV激活粘合剂,一经用UV辐照照射,UV激活粘合剂在针筒流体端口2246与管道针筒附接端2272之间形成粘合连接。还可以预期针筒流体端口2246与管道针筒附接端2272之间的鲁尔连接的反转。
参考图23A-B,示出了包含针筒流体端口2346与歧管管道2370之间的UV粘合接合的针筒/歧管连接配置的一方面。根据此方面,针筒流体端口2346与管道针筒附接端2372之间的接合限定针筒流体端口2346的内表面与管道针筒附接端2372的外表面之间的管状空间2380。当组装连接时,UV激活粘合剂被接收在管状空间2380内,其一经用UV辐照照射,形成针筒流体端口2346与管道针筒附接端2372之间的粘合连接。还可以预期针筒流体端口2346与管道针筒附接端2372之间的连接的反转。
参考图24A-B,示出了包含具有激光点焊的鲁尔密封的针筒/歧管连接配置的一方面。根据此方面,针筒流体端口2446可以包括母鲁尔连接器,其与管道针筒附接端2472上的公鲁尔连接器形成液体密封连接。一经组装鲁尔连接,激光点焊2480形成在针筒流体端口2446与管道针筒附接端2472之间的接口处。还预期针筒流体端口2246与管道针筒附接端2272之间的鲁尔连接的反转。
参考图25A和25B,流体注射器系统100可以具有传感器系统238,适配为识别何时SUDS 190与MUDS 130流体连通。传感器系统238可以包含至少一个感测元件,比如SUDS 190上的传感器鳍片240、以及流体注射器系统100或MUDS 130上的对应的传感器242。传感器242可以配置为检测至少一个传感器鳍片240或其他感测元件的存在和缺失。一些方面中,诸如至少一个传感器鳍片240的感测元件形成在SUDS 190的锁定片216上,比如图9A中所示。其他方面中,诸如至少一个传感器鳍片240的感测元件可以形成在SUDS 190的任意部分上。传感器242可以为光学传感器,其座置且固定在形成于流体注射器系统100的外壳102上的相应的安装件内。如动力医疗流体注射器领域精通的人员应理解的,传感器242可以电耦接到用于流体注射器系统的分立控制操作(比如至少部分基于来自传感器242的输入的一个或多个活塞元件的操作)的电子控制设备。诸如传感器鳍片240的感测元件可以具有一个或多个反射表面,其反射由传感器242检测的可见光或红外光。其他方面中,可以采用感测元件与传感器242之间的机械相互作用。
一些方面中,SUDS 190还可以包含防止重复使用的特征(未示出)。例如,SUDS 190可以包含一个或多个可破坏的传感器元件、片或结构,当从MUDS 130移除SUDS 190时,其折叠或断开。这些特征的缺失可以防止移除之后的SUDS 190的重新插入和重复使用。以此方式,可以确保SUDS 190仅用于一个流体递送程序。
已经总体上描述了流体注射器系统100、MUDS 130以及SUDS 190的部件,现在将详细描述使用SUDS 190的操作方法。使用中,医疗技师或用户从其包装(未示出)拆出可丢弃SUDS 190,且将流体入口端口202插入到MUDS 130上的连接端口192中。如上面所描述的,SUDS 190必须以正确取向插入,使得流体入口端口202对准以与连接端口192连接,并且废弃物出口端口204对准以与废弃物入口端口196连接。通过将锁定片216插入到MUDS 130上的接收槽217中,可以将SUDS 190固定到MUDS 130。一经将SUDS 190固定地连接到MUDS130,例如由传感器242感测到,流体注射器系统100(图1A和1B中所示)将流体抽入MUDS 130的多个针筒132中的一个或多个,并执行自动预备操作,以从MUDS 130和SUDS 190移除空气。在这样的预备操作期间,来自MUDS 130的流体通过连接端口192被注射,且进入SUDS190的管路208中。流体流动通过管路208,且通过废弃物出口端口204,且进入废弃物储器156中。自动预备操作一经完成,医疗技师从废弃物出口端口204断开连接器214。然后可以通过导管、血管接入设备、针或附加流体路径套件将连接器214连接到患者,以便对患者进行流体递送。流体递送一经完成,通过将SUDS 190的锁定片216从MUDS 130上的接收槽217脱离,使SUDS 190从患者和MUDS 130断开。医疗技师则可以丢弃SUDS 190。某些方面中,从MUDS 130移除SUDS 190导致防止激活重复使用特征(未示出),从而防止SUDS 190的重新插入和重复使用。
参考图26,示出了根据另一方面的SUDS 190与MUDS 130之间的连接接口。MUDS130具有连接端口192,其可以配置为中空、管状结构,具有鲁尔锁定连接器24(公鲁尔锁定连接器或母鲁尔锁定连接器,根据期望的应用),从端口192的远端延伸到端口192的内部。相应地,鲁尔锁定连接器24的近端开口凹陷在端口192的内部之内。鲁尔锁定连接器24可以包含螺丝螺纹30(图27B中所示),以将MUDS 130固定到SUDS 190。例如,螺丝螺纹30可以设置在围绕鲁尔锁定连接器24的外套管32上,如图27A和27B中所示。螺丝螺纹30还可以设置在鲁尔锁定连接器24自身上。鲁尔锁定连接器24限定从其延伸的流体通路34(图27B中所示),流体通路34从连接端口192的近端延伸到其远端开口。尽管连接端口192图示为包含鲁尔锁定连接器24,在本公开的范围内可以使用其他类型的连接器,包含但不限于夹入连接器、卡口(bayonet)连接器、压合连接器等。此外,某些方面中,用于连接端口192的连接器24理想地为非标准连接器(例如具有不常见尺寸或形状的连接器),使得由第三方生产的连接器无法附接。
MUDS 130具有废弃物入口端口196(图26中所示),其还可以配置为中空、管状结构。废弃物入口端口196包含附接到流体管道的渐缩的远端管口36,流体管道例如是将废弃物入口端口196连接到废弃物储器156(图2中所示)的柔性管路。
再次参考图26,如本文详细描述的,MUDS 130适配为连接到SUDS 190,SUDS 190在单次使用后丢弃。注意到,SUDS 190在图26中示出为从包装(未示出)移除之后的状态。使用之前,SUDS 190理想地包装在预灭菌、密封的包装中,其保护SUDS 190免受空气或表面传播的污染物的污染。
SUDS 190可以具有两个或更多个端口,其对应于MUDS 130的连接端口192和废弃物入口端口196。为了方便,SUDS 190的端口等同于参考图9A-9B所描述的SUDS 190的流体入口端口202和废弃物出口端口204。可以在外罩42中提供端口202,204,外罩42适于接收在MUDS 130的外壳20内,如图27B中所示。外罩42理想地具有不对称结构,使得用户仅能在一个取向上将SUDS 190附接到MUDS 130。因此,例如,防止用户将MUDS 130的连接端口192附接到SUDS 190废弃物出口端口204。SUDS 190的端口202、204和外罩42可以由适于医疗应用的材料制成,比如医用级塑料。SUDS 190的管路208通过止逆阀连接在流体入口端口202的近端与废弃物出口端口204的端部之间。可以以卷绕或盘绕的配置提供管路208,以易于包装和可操作性。
参考图27A和27B,SUDS 190流体入口端口202为中空、管状结构,配置为插入MUDS130的连接端口192。SUDS 190流体入口端口202包含管状管道,比如鲁尔锁定连接器44,限定从端口202的近端延伸的流体通路46,定位为相邻于MUDS 130,和端口204的远端,连接到管路208。鲁尔锁定连接器44适配为连接到MUDS 130的鲁尔锁定连接器24。当固定地连接时,MUDS 130的连接端口192与SUDS 190的流体入口端口202流体连通。鲁尔锁定连接器44可以包含拇指轮52,以将MUDS 130的连接端口192固定到SUDS 190流体入口端口202。拇指轮52可以与鲁尔锁定连接器44集成地形成,或可以为通过常规机构固定地连接到鲁尔锁定连接器44的分开的结构。拇指轮52旋转鲁尔锁定连接器44,使得从之延伸的片54接合连接端口192中的对应的螺丝螺纹30。管路208通过拇指轮52上的开口56连接到流体入口端口202,使得从MUDS 130到管路208建立连续流体连接。
继续参考图27A和27B,SUDS 190还包含SUDS 190废弃物出口端口204。SUDS废弃物出口端口204具有流体通路58,其由管状管道60限定,在MUDS 130的废弃物入口端口196与管路208之间延伸。管路208可以不直接连接到MUDS 130的废弃物入口端口196。反之,SUDS190的管状管道60可以将管路208与MUDS 130分开,从而确保管路208和连接器214与MUDS130的废弃物入口端口196隔离。管状管道60可以通过单次使用连接器外罩42的一部分从MUDS 130的废弃物入口端口196凹陷,以降低污染的可能性。管状管道60还可以相对于水平成角度,以促进流体流动通过SUDS 190废弃物出口端口204,且进入MUDS 130的废弃物入口端口196中。一些方面中,SUDS 190还可以包含防止重复使用的特征(未示出)。例如,SUDS190可以包含可断开的片或结构,当SUDS 190被从MUDS 130移除时,其折叠或破坏。以此方式,可以确保SUDS 190仅用于一个流体递送程序。
参考图28A-28F,现在将详细描述图26-27B中图示的SUDS 190与MUDS 130之间的连接组件的方面的操作方法。使用中,医疗技师或用户从其包装拆出可丢弃SUDS 190,且将SUDS 190插入到对应的MUDS 130中。如上面所描述的,SUDS 190必须以正确取向插入,使得MUDS 130的连接端口192接合SUDS 190流体入口端口202,并且MUDS 130的废弃物入口端口196接合SUDS 190废弃物出口端口204。如图28B中所示,然后医疗技师旋转拇指轮52,以将SUDS 190固定到MUDS 130。SUDS 190一经固定地连接到MUDS 130,流体注射器系统100(图1A和1B中所示)将流体抽取到MUDS 130的多个针筒132中的一个或多个中,并且执行自动预备操作(图28C),以从MUDS 130和SUDS 190移除空气。在这样的预备操作期间,来自MUDS130的流体被通过连接端口192注射,且进入到SUDS 190的管路208中。流体流动通过管路208,且通过废弃物出口端口204,且进入废弃物储器156。一旦自动预备操作完成,医疗技师从废弃物出口端口204断开连接器214(图28D)。然后可以通过导管、血管接入设备或附加的流体路径套件将连接器214连接到患者,以便对患者进行流体递送(图28E)。流体递送一经完成,用户将连接器214从患者移除,且旋转拇指轮52以从MUDS 130移除SUDS 190(图28F)。然后医疗技师可以丢弃SUDS 190。某些方面中,从MUDS 130移除SUDS 190使得防止重复使用的特征(比如从SUDS 190的部分延伸的片)(未示出)折叠或断开,防止SUDS 190的重新插入。
参考图29,图示了具有SUDS 190和MUDS 130的连接器组件的另一方面。在组件的此方面中,SUDS 190包含插管端口62,以接收连接到连接器214的针插管129。在从患者移除之后,用于对患者进行流体递送的插管129可以插入到插管端口62中。在丢弃插管129期间,插管端口62可以覆盖插管129的污染的端部。在此方面中,单次使用外罩42理想地足够长,使得针插管129的整体长度可以插入外罩42中,以安全丢弃。
参考图30A和30B,图示了具有SUDS 190和MUDS 130的连接器组件的另一方面。连接器组件提供为垂直取向,MUDS 130的连接端口192设置于废弃物入口端口196上方。MUDS130包含滴落通道64,滴落通道64在连接端口192与废弃物入口端口196之间延伸。从连接端口192泄露的任何流体由重力朝下引导通过滴落通道64。滴落通道64离开到废弃物入口端口196中。相应地,从滴落通道64排出的任何流体被引导通过废弃物入口端口196且收集在废弃物储器156中。可替代地,MUDS 130可以设置有吸收剂材料,比如图30C中所示的吸收剂垫66,其围绕连接端口192和废弃物入口端口196的一部分。提供吸收剂材料,以吸收在SUDS190的移除期间滴落的任何流体,用于改善的滴落管理。
参考图31A-31C,图示了具有SUDS 190和具有多个压合连接器的MUDS 130的连接器组件的另一方面。如图31A所示,SUDS 190包含流体入口端口202和废弃物出口端口204。SUDS 190包含断开片68,而非拇指轮。SUDS 190还包含对准结构70,对准结构70从SUDS 190的外罩42延伸,且配置为插入到MUDS 130(图31B所示)的对应的槽72中。
如图31C中图示的截面图所示,通过对准通道71,SUDS 190插入到MUDS 130中且与之对准。断开片68与管状套管74集成地形成,管状套管74在其一端具有朝内延伸的凸缘76。套管74围绕SUDS 190上的管状管道80。当SUDS 190插入到MUDS 130中时,凸缘76与对应的脊78形成过盈接合,脊78从MUDS 130的连接端口192的一部分延伸。过盈接合在MUDS 130与SUDS 190之间创建实质上流体密封的连接。按压SUDS 190的断开片68,将凸缘76从脊78脱离,以允许用户将SUDS 190从MUDS 130移除。参考图32,还可以以垂直配置提供上述的具有MUDS 130和具有断开片68的SUDS 190的连接组件。
参考图33A和33B,图示了具有SUDS 190和MUDS 130的连接器组件的另一方面。MUDS 130包含连接端口192和废弃物入口端口196,如之前的方面中所描述的。连接端口192包含共模制密封表面82,以增强SUDS 190与MUDS 130之间的连接。SUDS 190包含外部对准表面84,其与外罩42集成地形成,用于将SUDS 190和MUDS 130正确对准。对准表面84也使SUDS 190的流体入口端口202和废弃物出口端口204凹陷,以降低使用之前的污染的可能性。
参考图34A-36B,图示了管路208的各种方面。例如,管路208可以绕保持结构133(比如线轴或框架构件)卷绕,以确保在从其包装移除时或当SUDS 190连接到MUDS 130时,管路208不解开。参考图36A,管路208还可以包含可移除的外部夹135。夹135绕卷绕管路208连接,以防止管路208在从包装移除或自动预备期间解开。参考图36B,在其他方面中,管路208提供有未盘绕部分137,以保持管路208离开SUDS 190。当SUDS 190连接到MUDS 130时,管路208的盘绕部分139悬挂在未盘绕部分137下方。
参考图37,电子控制设备900可以与流体注射器系统100相关联,以控制填充和递送操作。一些方面中,电子控制设备900可以控制各种阀、活塞构件以及其他元件的操作,以实现期望的填充或递送程序。例如,电子控制设备900可以包含各种分立的计算机可读介质部件。例如,此计算机可读介质可以包含可由电子控制设备900访问的任意介质,比如易失性介质、非易失性介质、可移除介质、不可移除介质、瞬态介质、非瞬态介质等。作为其他示例,此计算机可读介质可以包含计算机存储介质,比如以任意方法或技术实施的用于存储信息的介质,比如计算机可读指令、数据结构、程序模块或其他数据;随机存取存储器(RAM)、只读存储器(ROM)、电可擦除可编程只读存储器(EEPROM)、闪存存储器或其他存储器技术;CD-ROM、数字通用光盘(DVD)或其他光盘存储;磁带盒、磁带、磁盘存储器或其他磁性存储设备;或可以用来存储期望的信息且可以由电子控制设备900访问的任意其他介质。此外,此计算机可读介质可以包含通信介质,比如计算机可读指令、数据结构、程序模块、或调制的数据信号中的其他数据,比如载波或其他传输机制,并且包含任意信息递送介质,有线介质(比如有线网络和直连有线连接),以及无线介质(比如声学信号、射频信号、光学信号、红外信号、计量生物学信号、条形码信号等)。当然,上述的任意组合也应包含在计算机可读介质的范围内。
电子控制设备900还包含系统存储器908,其具有易失性和非易失性存储器形式的计算机存储介质,比如ROM和RAM。带有适当的基于计算机的例程的基本输入/输出系统(BIOS)辅助在电子控制设备900内的部件之间传输信息,并且通常存储在ROM中。系统存储器908的RAM部分典型地含有立即可访问或当前在处理单元904上操作的数据和程序模块,例如,操作系统、应用编程接口、应用程序、程序模块、程序数据、以及其他基于指令的计算机可读代码。
继续参考图37,电子控制设备900还可以包含其他可移除或不可移除、易失性或非易失性、瞬态或非瞬态计算机存储介质产品。例如,电子控制设备900可以包含不可移除存储器接口910,其与硬盘驱动器912通信且对其进行控制,例如,不可移除、非易失性磁介质;以及可移除、非易失性存储器接口914,其与以下通信且对其进行控制:磁盘驱动器单元916(其读取和写入到可移除、非易失性磁盘918)、光盘驱动器单元920(其读取和写入到可移除,非易失性光盘922,比如CD ROM)、用于与可移除存储器卡等连接的通用串行总线(USB)端口921、等等。然而,设想的其他可移除或不可移除、易失性或非易失性计算机存储介质可以用于示例性计算系统环境902中,包含但不限于磁带盒、DVD、数字视频磁带、固态RAM、固态ROM等。这些各种可移除或不可移除、易失性或非易失性磁介质经由系统总线906与电子控制设备900的处理单元904和其他部件通信。在上面讨论且在图37中图示的驱动器及它们相关联的计算机存储介质提供对操作系统、计算机可读指令、应用程序、数据结构、程序模块、程序数据以及其他基于指令的、用于电子控制设备900的计算机可读代码(无论系统存储器908中的此信息和数据的复制与否)的存储。
用户可以通过某些可附接或可操作输入设备(比如图1A所示的用户界面124)经由用户输入接口928将命令、信息以及数据输入到电子控制设备900。当然,可以采用各种这样的输入设备(例如,麦克风、轨迹球、操纵杆、触摸板、触摸屏、扫描器等),包含便于将数据以及信息从外部源输入到电子控制设备900的任意布置。如所讨论的,这些和其他输入设备通常通过耦接到系统总线906的用户输入接口928连接到处理单元904,但可以通过其他接口和总线结构连接,比如并行端口、游戏端口或USB。此外,可以将数据和信息以可理解的形式或通过某些输出设备(比如监视器930(以电子形式视觉显示此信息和数据)、打印机932(以打印形式物理地显示此信息和数据)、扬声器934(以可听形式听觉地呈现此信息和数据)等)的格式呈现给或提供到用户。全部这些设备通过耦接到系统总线906的输出接口936与电子控制设备900进行通信。可以设想用来向用户提供信息和数据的任意这样的外围输出设备。
电子控制设备900可以通过使用通信设备940在网络环境938中运行,通信设备940集成到电子控制设备900或远离电子控制设备900。此通信设备940通过通信接口942与电子控制设备900的其他部件可操作或与之通信。使用这样的布置,电子控制设备900可以与一个或多个远程计算机连接或与之通信,远程计算机比如为远程计算机944,其可以为个人计算机、服务器、路由器、网络个人计算机、对等设备或其他常见网络结点,并且典型地包含上面描述的与电子控制设备900连接的许多或全部部件。使用适当的通信设备940(例如,调制解调器,网络接口或适配器等),计算机944可以在局域网络(LAN)和广域网络(WAN)内运行和通过其通信,但还可以包含其他网络,比如虚拟私人网络(VPN)、办公室网络、企业网络、内联网、互联网等。
如本文使用的,电子控制设备900包含或可操作为执行适当定制化设计或常规的软件,以执行和实现本公开的方法的处理步骤和系统,从而形成专门和特定的计算系统。相应地,目前公开的方法和系统可以包含一个或多个电子控制设备900或相似的计算设备,其具有能够存储使得处理单元904执行、配置或以其他方式实现后文中所讨论的与本公开相关的方法、过程、以及转换数据操纵的计算机可读程序代码或指令的计算机可读存储介质。此外,电子控制设备900可以为个人计算机、个人数字助理、便携式计算机、膝上式计算机、掌上计算机、移动设备、移动电话、处理器或任意其他形式的计算设备,其具有必要处理硬件以适当地处理数据,以有效地实现目前公开的计算机实施的方法和系统。
相关领域技术人员将清楚,系统可以采用物理地位于一个或多个计算机上的数据库,其可以与其相应的服务器相同或不同。例如,电子控制设备900上的编程软件可以控制物理地存储在网络的分开的处理器上的或其他位置的数据库。
一些方面中,电子控制设备900可以编程为使得基于相应的针筒132中的预编程的触发最小容积而发生自动重新填充。例如,当针筒132的至少一个中的流体剩余的容积少于编程的容积时,针筒重新填充程序由电子控制设备900自动地启动。通过追踪在流体注射器系统100的操作期间从相应的针筒132分配的流体容积,与流体注射器系统100相关联的电子控制设备900可以确定已经达到预编程的触发最小容积。可替代地,流体液位传感器可以整合到流体注射器系统100中,并且来自这些流体液位传感器的输入可以提供到电子控制设备900,使得电子控制设备900可以确定何时在针筒132中的至少一个中已经达到预编程的触发最小容积。重新填充的填充容积和速率可以预编程在电子控制设备900中。自动重新填充程序可以通过电子控制设备900自动停止或可以手动打断。此外,可以当流体注射程序的完成,针筒132中的至少一个没有足够的流体来执行下一次编程的流体注射程序时,启动自动重新填充程序。
在重新填充程序期间,与相应的针筒132相关联的体相流体源120中的一个或多个可能变空,(例如,初始时缺乏足够的流体来完成一个或多个针筒132的完整的重新填充)。因此,替换体相流体源120是必需的,并且理想的是快速进行这样的体相流体源120的替换。流体注射器系统100可以具有指示器,比如听觉和/或视觉指示器,以指示操作员在可以使用流体注射器系统100之前需要体相流体源120的更换。
尽管多流体递送系统及其多次和单次使用可丢弃套件(SUDS)连接器的若干方面在附图中示出且在上文中详细描述,在不背离本公开的范围和精神的情况下,对于本领域技术人员来说,其他方面将是显而易见且容易进行的。例如,应当理解,本公开预期在可能的范围内,任意方面的一个或多个特征可以与任意其他方面的一个或多个特征组合。相应地,前述说明书意图为阐述性而非限制性。
Claims (32)
1.多次使用可丢弃套件,包括:
多个针筒,每个针筒具有近端和沿着纵向轴线与所述近端间隔开的远端,在所述多个针筒中的每一个的所述远端处的填充端口和排放出口,以及在所述多个针筒中的每一个的针筒内部之内在所述近端与所述远端之间可往复地移动的柱塞;
歧管,所述歧管与所述多个针筒中的每一个的所述排放出口可选择流体连通;
至少一个可旋转阀,所述至少一个可旋转阀与所述多个针筒中的至少一个的所述远端流体连通,其中所述至少一个可旋转阀包括阀头,所述阀头具有凹陷到所述阀头中的槽,其中所述槽在所述槽的一端处具有唇,所述唇将流体注射器的耦接机构的叶片的取向限制为单个自对准取向,其中所述至少一个可旋转阀在填充位置与递送位置之间可旋转地操作,所述填充位置用于通过所述填充端口填充所述多个针筒中的至少一个的所述针筒内部,所述递送位置用于通过所述歧管从所述多个针筒中的至少一个的所述针筒内部将流体递送到所述歧管;以及
至少一个连接端口,当所述至少一个可旋转阀在所述递送位置中时,所述至少一个连接端口与所述歧管流体连通,
其中当所述至少一个可旋转阀处于所述递送位置时,所述填充端口与所述针筒内部流体隔离。
2.如权利要求1所述的多次使用可丢弃套件,其中在连接到所述多个针筒中的至少一个的框架上提供所述至少一个连接端口。
3.如权利要求1或2所述的多次使用可丢弃套件,其中所述至少一个连接端口通过递送管线与所述歧管流体连通。
4.如权利要求1或2所述的多次使用可丢弃套件,还包括与废弃物储器流体连接的废弃物端口。
5.如权利要求1或2所述的多次使用可丢弃套件,其中所述多个针筒中的每一个包括具有尖刺的填充管线,所述尖刺配置为用于连接到体相流体源,并且其中每个填充管线配置为,当所述至少一个可旋转阀在所述填充位置中时填充所述针筒内部。
6.如权利要求1所述的多次使用可丢弃套件,其中所述歧管具有流体通路,所述流体通路与所述多个针筒中的每一个的排放出口流体连通。
7.多流体注射器系统,包括:
动力注射器,包括封闭多个可往复地操作的活塞元件的外壳;
接收空间,所述接收空间配置为用于可移除地接收多次使用可丢弃套件的多个针筒,所述接收空间包括底部板和与所述底部板由后侧壁间隔开的顶部板,使得在所述顶部板与所述底部板之间轴向地支撑所述多次使用可丢弃套件的所述多个针筒;以及
与所述接收空间相关联的至少一个导轨,
其中所述至少一个导轨在朝向所述后侧壁的插入方向上变窄,以将所述多次使用可丢弃套件引导到所述接收空间中,并且
其中所述顶部板限定多个槽,是多个槽配置为接收所述多次使用可丢弃套件的多个针筒中的至少一个,并且其中所述多个槽中的每一个限定配合凹陷,所述配合凹陷用于接收所述至少一个针筒的锥形远端,使得当所述多次使用可丢弃套件被接收在所述接收空间中时,所述锥形远端接合所述配合凹陷。
8.如权利要求7所述的多流体注射器系统,还包括多个体相流体连接器,所述多个体相流体连接器配置为用于将所述多次使用可丢弃套件与至少一个体相流体源连接。
9.如权利要求7或8所述的多流体注射器系统,其中所述顶部板在第一位置与第二位置之间可移动,所述第一位置配置为用于所述接收空间内的所述多次使用可丢弃套件的插入和移除,并且所述第二位置配置为用于在所述接收空间内锁定所述多次使用可丢弃套件。
10.如权利要求9所述的多流体注射器系统,其中所述顶部板包括用于将所述顶部板锁定在所述第二位置中的闩锁。
11.如权利要求7或8所述的多流体注射器系统,还包括至少一个耦接器,所述至少一个耦接器配置为用于接合所述多次使用可丢弃套件上的至少一个阀。
12.如权利要求11所述的多流体注射器系统,其中所述至少一个耦接器为可旋转耦接器,所述可旋转耦接器具有叶片,所述叶片配置为用于与形成在所述多次使用可丢弃套件上的所述至少一个阀上的槽自对准。
13.多次使用可丢弃套件,包括:
至少一个针筒,所述至少一个针筒具有近端和沿着纵向轴线与所述近端间隔开的远端,在所述至少一个针筒的远端处的填充端口和排放出口,以及在所述至少一个针筒的内部之内在所述近端与所述远端之间可往复地移动的柱塞;
歧管,所述歧管与所述至少一个针筒的所述排放出口可选择流体连通;
至少一个可旋转阀,所述至少一个可旋转阀与所述至少一个针筒中的每一个的内部流体连通,其中所述至少一个可旋转阀包括阀头,所述阀头具有凹陷到所述阀头中的槽,其中所述槽在所述槽的一端处具有唇,所述唇将所述流体注射器的耦接机构的叶片的取向限制为单个自对准取向,其中所述至少一个可旋转阀在通过所述填充端口用流体填充所述至少一个针筒的内部的填充位置与通过所述排放出口从所述至少一个针筒的内部递送所述流体的递送位置之间可旋转地操作;以及
至少一个连接端口,当所述至少一个可旋转阀在所述递送位置中时,所述至少一个连接端口与所述歧管和所述至少一个针筒的内部流体连通,
其中当所述至少一可旋转阀处于所述递送位置时,所述填充端口与所述至少一个针筒的内部流体隔离。
14.如权利要求13所述的多次使用可丢弃套件,其中所述槽成型为接收所述耦接机构的至少一部分,以当所述耦接机构接合所述至少一个可旋转阀的所述槽时,将所述至少一个可旋转阀在所述填充位置与所述递送位置之间旋转。
15.如权利要求13所述的多次使用可丢弃套件,其中所述槽在从所述至少一个可旋转阀的远端向所述至少一个可旋转阀的近端的方向上变窄。
16.如权利要求13-15中任一项所述的多次使用可丢弃套件,其中所述至少一个可旋转阀在所述填充位置与所述递送位置之间之内可旋转,在所述填充位置所述填充端口与所述至少一个针筒的内部流体连通,在所述递送位置所述歧管通过所述排放出口与所述至少一个针筒的内部流体连通。
17.如权利要求13-15中任一项所述的多次使用可丢弃套件,其中,在所述填充位置中,所述至少一个可旋转阀为可操作的,以通过与体相流体源流体连通的所述填充端口填充所述至少一个针筒的内部,并且在所述递送位置中,所述至少一个可旋转阀是可操作的,以通过与所述歧管流体连通的排放出口从所述至少一个针筒的内部递送流体。
18.如权利要求13-15中任一项所述的多次使用可丢弃套件,其中所述至少一个连接端口提供在框架上,所述框架连接到所述至少一个针筒。
19.如权利要求13-15中任一项所述的多次使用可丢弃套件,其中所述至少一个连接端口通过递送管线与所述歧管流体连通。
20.如权利要求13-15中任一项所述的多次使用可丢弃套件,其中所述至少一个连接端口具有与废弃物储器流体连通的废弃物端口。
21.如权利要求17所述的多次使用可丢弃套件,还包括填充管线,所述填充管线具有用于连接到体相流体源的尖刺,其中当所述至少一个可旋转阀在所述填充位置中时,流体从所述体相流体源和所述填充管线以通过所述填充端口的流体流动到所述至少一个针筒的内部中。
22.如权利要求13所述的多次使用可丢弃套件,其中所述歧管具有流体通路,所述流体通路与所述至少一个针筒的排放出口流体连通。
23.多流体注射器系统,包括:
动力流体注射器,所述动力流体注射器包括外壳,所述外壳封闭至少一个可往复地操作的活塞元件;
多次使用可丢弃套件,所述多次使用可丢弃套件可连接到所述动力流体注射器,所述多次使用可丢弃套件包括:
至少一个针筒,所述至少一个针筒具有近端和沿着纵向轴线与所述近端间隔开的远端,以及在针筒内部之内在所述近端与所述远端之间由所述至少一个活塞元件可往复地移动的柱塞;
歧管,所述歧管与所述至少一个针筒的所述远端流体连通;
至少一个阀,所述至少一个阀与所述针筒内部流体连通,所述至少一个阀在用流体填充所述针筒内部的填充位置与从所述针筒内部递送所述流体的递送位置之间可操作;以及
至少一个连接端口,当所述至少一个阀在所述递送位置中时,所述至少一个连接端口与所述歧管和所述针筒内部流体连通;以及
耦接机构,用于在所述填充位置与所述递送位置之间操作所述至少一个阀,
其中所述耦接机构包括叶片,并且其中所述至少一个阀具有槽,所述槽成型为接收所述耦接机构的叶片。
24.如权利要求23所述的多流体注射器系统,其中,当所述耦接机构的所述叶片被接收在所述至少一个阀的所述槽内时,所述耦接机构的旋转使得所述至少一个阀旋转。
25.如权利要求23或24所述的多流体注射器系统,其中所述耦接机构与所述至少一个阀自对准,以将所述耦接机构的所述叶片接收在所述至少一个阀的所述槽内。
26.如权利要求23或24所述的多流体注射器系统,其中所述耦接机构被弹簧加载,以随着所述耦接机构的所述叶片旋转到与所述至少一个阀的所述槽对准时,保持与所述至少一个阀接触。
27.如权利要求23或24所述的多流体注射器系统,其中,当所述耦接机构的所述叶片与所述至少一个阀的所述槽对准时,所述叶片在有弹力的弹性构件的回复动作下被驱策到所述槽中。
28.如权利要求23或24所述的多流体注射器系统,还包括用于操作所述耦接机构的驱动机构。
29.如权利要求28所述的多流体注射器系统,其中所述驱动机构旋转所述耦接机构。
30.如权利要求23或24所述的多流体注射器系统,其中所述叶片具有至少一个倾斜表面,所述至少一个倾斜表面相对于所述至少一个阀的纵向轴线成角度。
31.多次使用可丢弃套件,包括:
多个针筒,每个针筒具有近端和沿着纵向轴线与所述近端间隔开的远端,在所述多个针筒中的每一个的远端处的填充端口和排放出口,以及在所述多个针筒中的每一个的内部之内在所述近端与所述远端之间可往复地移动的柱塞;
歧管,所述歧管连接到所述多个针筒中的每一个的所述排放出口;
与所述歧管相关联的至少一个可旋转阀,所述至少一个可旋转阀在填充位置与递送位置之间可旋转操作,所述填充位置通过填充端口填充所述多个针筒中的至少一个的所述针筒内部,所述递送位置通过所述排放出口从所述多个针筒中的至少一个的所述针筒内部将流体递送到所述歧管;
至少一个填充管线,当所述至少一个可旋转阀在所述填充位置中时,所述至少一个填充管线与体相流体源的内部和所述多个针筒中的至少一个的针筒内部流体连通;以及
至少一个连接端口,当所述至少一个可旋转阀在所述递送位置中时,所述至少一个连接端口与所述歧管和所述多个针筒中的至少一个的所述针筒内部流体连通,
其中所述至少一个可旋转阀具有阀头,所述阀头具有凹陷到所述阀头中的槽,
其中所述槽被成型为接收流体注射器的耦接机构的至少一部分,以当所述耦接机构接合所述至少一个可旋转阀的所述槽时,将所述至少一个可旋转阀在所述填充位置与所述递送位置之间旋转,其中所述槽在所述槽的一端处具有唇,所述唇将所述耦接机构的叶片的取向限制为单个自对准取向;并且
其中当所述至少一个可旋转阀处于所述递送位置时,所述填充端口与所述针筒内部流体隔离。
32.如权利要求31所述的多次使用可丢弃套件,其中所述歧管具有流体通路,所述流体通路与所述多个针筒中的每一个的排放出口流体连通。
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