CN101355976A - 注射装置 - Google Patents
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Abstract
本发明涉及一种用于间歇或连续施用治疗物质例如胰岛素的装置，该装置包括其上固定注射部和输送部(3、4)的基部。输送部包括储器和泵，注射部包括基板(10)、插管部(1)和用于将基板(10)固定在使用者皮肤上的构件，插管部(1)具有带贯通开口的主体和至少一个具有从主体的下侧伸出的近端的插管。该装置的特征在于输送部(3、4)和注射部通过连接器(2)装配，连接器(2)包括引导流体从储器(4)流至插管部(1、1b)中的贯通开口的流体通道，该流体通道包括用于在连接器(2)从输送部(3、4)和/或注射部上拆下时阻止进入注射部的构件(7、8、8b、8c)。
Description
技术领域
本发明涉及一种用于间歇或连续施用治疗物质例如胰岛素的装置，该装置包括其上固定注射部和输送部的基部。该输送部包括储器和泵，该注射部包括带有贯通开口的主体和至少一个具有从主体下侧伸出的近端的插管。
背景技术
EP-A1-1.527.792描述了一种包括经皮进入单元和储器的医疗装置。该经皮进入单元包括用于输送流体穿过对象皮肤部的经皮进入构件，和适于应用在对象皮肤上的安装面。该储器单元包括适于装流体药品的储器和允许与储器内部流体连通地布置经皮进入构件的出口。该装置还包括用于排出的构件例如泵，该构件在使用期间将流体药品排出储器并经由经皮进入构件穿过患者皮肤。经皮进入单元和储器单元进一步包括允许储器单元在使用期间固定在经皮进入单元上的可释放配合联接构件。本发明的目的是提供可皮肤安装的药品输送装置或系统，并允许以方便且有成本效益的方式使用这种装置或系统。
根据该文献，所描述实施例的插入针(113、212或412)可枢转地布置在针壳内部并且可以在延伸和缩回位置之间移动。当注射针插入时，它穿透隔膜进而穿透对象的皮肤。根据本发明，位于皮下的插管相对于装置的基部静止，其中该基部以某种方式粘附在使用者身上。
US 2004/0204673 A1描述了一种能够可调节和可编程地输送流体的质量轻且成本低的流体输送装置，该装置包括围绕储器室的外壳。与储器室流体连通的是用于从储器中分配限定量流体的分配器。该分配器由流体输送装置的电子微控制器控制。该流体输送装置进一步包括接收来自远程控制装置的信息的通信元件，其中该远程控制装置没有与本发明的流体输送装置机械连接。还包括与分配器流体连通的出口组件，液态药品从该出口组件离开流体输送装置并经皮进入哺乳动物患者的体内。
每一个外壳702、802都可以由柔性材料制成，或者可以具有柔性铰接段，该柔性铰接段允许流体输送装置10在患者活动期间弯曲以防止脱离和使患者有舒适感，但是没有指示应当如何构造这种铰接段。
发明内容
本发明的目的是提供一种包括泵、储器和注射部的用于输送流体的装置，该装置确保储器和注射部之间的流体密封连接。根据本发明的装置构造成具有能够将输送部容易地连接在注射部上和容易地拆下并同时确保流体密封连接和防止微生物侵入装置部件的构件。根据本发明的优选实施例，还确保佩带者在使用该装置期间有较小的不舒适感，这是因为本实施例具有在输送部受接触或运动的影响时减少从相对重的输送部至注射部的动作传送的构件。
根据权利要求1，本发明包括用于输送流体的装置，该装置包括注射部和流体输送部(3、4)，流体输送部和注射部可以被分开并重新接合，流体输送部包括储器、例如泵形式的传送构件和外壳，并且注射部包括：
-基板，
-包括带有贯通开口的主体的插管部，其具有延伸经过基板的近侧的插管，和
-将基板固定在使用者皮肤上的构件，
其中输送部和注射部通过连接器装配，该连接器包括引导流体从储器流至插管部中的贯通开口的流体通道，该流体通道包括用于在连接器从输送部和/或注射部上拆下时阻止进入注射部的构件。根据本发明的一个实施例，该装置包括用于在连接器与输送部分开时阻止进入输送部的构件。该实施例通常在输送装置的储器可以从注射部上取下而后再安装上进一步使用时使用。根据该实施例或其它实施例，基板具有固定构件，该固定构件用于连接和拆下从基板远侧延伸出的输送装置。
当连接器是装置的一部分时，可以在输送部和注射部之间提供流体密封连接。当装置构造成具有相互连接部件时，还可以增加其它有利特征，例如用于减小从重的输送部传送至部分插入使用者皮肤的注射部的冲击力的构件。这些特征使得使用者可以更安全舒适地佩带该装置。
“储器”是装置的一部分，液体保持在其中，该液体是任何类型的必须以一定时间间隔以一定量输送给患者的药剂。“输送部”是装置的一部分，其保持液体存储并且确保液体输送至注射部。“注射部”限定一种端口，该端口固定在使用者皮肤上并且具有用于传送液体给使用者的构件，例如插管。该注射部不包括任何重的或体积大的部件。
在优选实施例中，当连接器从输送部和/或注射部上拆下时，穿过连接器至流体通道的端部开口被阻塞。该特征涉及希望较长时间使用的产品，这使得可以更换储器和可以拆下例如输送部成为必要。优选的是，使用可以被针状物体穿透的隔膜阻塞穿过连接器至流体通道的开口。
在另一个优选实施例中，装置的部件具有至少两个位置，即第一位置和第二位置，在第一位置，储器的出口用微生物不能透过的第一屏障阻塞，并且注射部中的贯通开口的进口用微生物不能透过的第二屏障阻塞，在第二位置，通过穿过第一和第二屏障在储器和注射部中的贯通开口之间形成开放的流体连接。一个或同时两个屏障包括可以被针状物体穿透的材料，其中在针状物体缩回时开口闭合，或者一个或同时两个屏障可以包括硬表面，该硬表面在一个位置形成位于出口管的出口和贯通流体通道的进口之间的区域中的开口，在另一个位置闭合贯通流体通道。优选的是注射部和输送部通过一个或多个柔性区彼此连接。更优选的是连接器通过一个或多个非柔性连接与一个部件连接并且通过柔性区与另一个部件连接。最优选的是连接器通过柔性区与注射部连接。
在一个优选实施例中，至少一个柔性区由缩减了材料尺寸的区域构成。
在另一个优选实施例中，至少一个柔性区由更柔软和更易曲的材料制成的区域构成。
在第三个优选实施例中，至少一个柔性区由通过其形式而具有延伸和压缩能力的材料(例如被打褶或折叠的材料)制成的区域构成。
优选的是注射部和输送部不通过非柔性或刚性区彼此连接，因为这将减小柔性区的效果。注射部和输送部不通过非柔性或刚性区彼此连接意味着只有柔性区连接注射部和输送部。
在优选实施例中，该装置包括固定在患者皮肤上的基部，输送部固定在基部的第一部上，注射部固定在基部的第二部上，一个或多个柔性区位于基部的第一部和第二部之间。优选的是输送部可释放地固定在基部上，并且连接器不可释放地固定在基部上。连接器也优选固定在基部的第一部上，并且更优选的是连接器通过非柔性连接不可释放地固定在基部的第一部上。在所述实施例中，基部描述为相对平的部件，但是“基部”可以是任何可以将注射部和输送部联合或结合成一个单元的构造，该单元可以直接固定在皮肤上由使用者佩带。
当柔性区设置在相对重的输送装置和注射装置之间时，可以防止或至少显著减少从输送装置至注射装置的动作传送，并且将保护位于皮下的插管的注射部位不受任何由于推动或接触输送部而引起的相互作用的主要部分的影响。输送部经常通过防止动作传送的相对长的管与注射部物理地分离，但是当输送部与注射装置设置在一起时，佩带根据本发明的装置的使用者将较少感觉到不舒服。通过使用连接器可以避免输送部和注射部之间的直接接触，同时可以将这两个部件作为一个单元固定在使用者皮肤上。
插管可以从注射部主体的近侧或该主体的侧面伸出。如果如图4和图7中所示实施例那样插管从主体的侧面伸出，插管通常将是弯曲的，并且将优选使用至少部分由柔软且易曲的材料制成的插管。如果插管如图12中所示从主体近侧伸出，则该插管可以由硬质材料例如金属制成或者可以由柔软且易曲的材料制成。
根据本发明，连接器针可以是单针的一端，单针的另一端起插管的作用。当连接器针和插管形成为一个针时，它通常将由金属或硬质聚合体制成，但是它也可以由在连接器端硬化而在插管端未硬化而且柔软的聚合体制成。单针也可以由两种不同的材料组成，硬质材料用于连接器端，而相对柔软的材料用于插管端。连接器针和插管也可以分成至少两个针。于是注射部可以具有普遍公知的软插管，该插管可以在附接于单独的插入器上的插入针的帮助下插入，而连接器针可以由硬质材料制成并且固定在注射部或输送部上。
柔性区由缩减了材料尺寸的区域构成，例如可以在材料上设置开口或切口，或者可以减小材料的厚度，或者该柔性区由更柔软且更易曲材料制成的区域构成，或者由因为通过形式或结构而具有延伸和压缩能力的材料(例如被打褶或折叠的材料)制成的区域构成。
优选的是在非连接状态下，即当储器和连接部分开时，防止微生物进入储器，因为当这两个部件分开时储器的开口被阻塞。
术语“经过”包括使流动穿过或绕过屏障的任何可行方式，在本发明的多数实施例中通过用针穿透屏障而经过屏障，但是也有例子(图18A和B)是通过推开硬质盖从而形成流动通道而经过屏障。
如果屏障包括可以用针状物体穿透的材料时，在针状物体缩回时开口闭合。针状物体可以是钝的或是尖锐的，这意味着针状物体或者推进穿过屏障或者切割穿过屏障。如果其中一个屏障包括硬质表面，即不可穿透的表面，将必须移动屏障，从而在出口管的出口和贯通流体通道的进口之间的区域中形成开口。
在最优选实施例中，该装置利用粘附在基部近侧或注射部近侧上的安装垫固定在患者皮肤上，基部或注射部上安装垫的粘附可以包括胶、维可牢尼龙搭扣(Velcro)、模制等。
附图说明
现在将参考附图对本发明的实施例进行描述，其中：
图1示出了从图3中所示B-B线的上面看过去的本发明的第一实施例，其中输送部设置在注射部的旁边。
图2示出了图1中实施例的标记有圆圈的放大部。
图3示出了从显示线B-B侧看过去的图1实施例。
图4示出了第一实施例，其中输送部与注射部分离。
图5示出了图4中实施例的标记有圆圈的放大部。
图6A示出了从注射部侧看过去的本发明的第二实施例。
图6B示出了从穿过线B-B的切割部看过去的图6A中的同一实施例。
图7示出了图6B中实施例的标记有圆圈的放大部。
图8A示出了与输送部分离的第二实施例的注射部和基部。
图8B示出了图8A中实施例的标记有圆圈的放大部。
图9示出了第二实施例的输送部和注射部。
图10A示出了从不同角度看过去的图8A的同一实施例。
图10B示出了图10A中实施例的标记有圆圈的放大部。
图11示出了处于连接状态的根据本发明的输送装置的第三实施例，并且在该实施例中输送部设置在注射部顶部。
图12示出了处于分离状态的装置的第三实施例。
图13分别从上侧和下侧示出了第三实施例的两个部件。
图14示出了根据本发明的输送装置的第四实施例。“A”示出了从侧面看过去的输送部以及准备与输送部连接的注射部，“B”示出了从远处看过去的输送部，同时“C”示出了从上面看过去的注射部。
图15示出了从(线V-V)侧看过去的处于分离状态的第四实施例。
图16示出了从(线V-V)侧看过去的处于连接状态的第四实施例。
图17示出了根据本发明的输送装置的第五实施例，该输送装置在输送部和注射部之间具有流体密封锁定。
图18A和18B示出了处于两个状态的第五实施例的放大部；在第一状态下装置关闭流体的流动，在第二状态下装置打开流体的流动。
图19示出了确保流体从输送部至注射部的流体密封传送的另一个实施例。
图20示出了具有配置了中心连接器和周边注射部的基部的第六实施例。
图21示出了从上面和侧面看过去的处于接合状态的第六实施例的输送装置和基部。
图22示出了图21的处于接合状态的第六实施例的剖视图。
图23示出了图22的连接器部件的放大图。
图24示出了图22的注射器部件的放大图。
图25示出了从第六实施例的输送部的下面看过去的视图。
图26示出了具有配置有中心组合连接器和注射部的基部的第七实施例。
图27示出了从侧面和上面看过去的处于接合状态的第七实施例的输送装置和基部。
图28示出了图27的处于接合状态的第七实施例的剖视图和组合式连接器/注射部的放大图。
图29示出了从第七实施例的输送部的下面看过去的视图。
图30示出了具有配置了中心组合式连接器和注射部的基部的第八实施例，其中该组合式部件分成多个单元。
图31示出了从上面和侧面看过去的第八实施例的输送装置和基部。
图32示出了图31的处于接合状态的第八实施例的剖视图和组合式连接器/注射部的放大图。
图33示出了具有配置了中心连接器和周边注射部的椭圆形基部的第九实施例。
图34示出了从下面看过去的处于分离状态的第九实施例的输送装置和基部以及从侧面看过去的储器和基部。
图35示出了从侧面和上面看过去的处于接合状态的第九实施例的输送装置和基部。
图36示出了图35的处于接合状态的第九实施例的剖视图和注射部的放大图。
具体实施方式
图1-3示出了本发明的第一实施例，其中输送部和注射部彼此固定。在图1中该实施例是从图3中所示B-B线上面看过去的，同时图2示出了放大形式的图1的一小部分。该装置包括注射部1、连接器2、包括泵3和储器4的输送部、在注射部1和输送部之间形成流体连接的柔性管5、可以同时穿透覆盖连接器入口的保护密封件7和覆盖储器入口的隔膜8的连接器针6、以及使用时放置在皮下的插管9。在图1-3中，该装置处于注射部和输送部接合在一起并且随时可使用的连接状态。
图2示出了图1的连接器2的放大图。在该实施例中，连接器2包括非柔性材料制成的具有贯通开口的模制部，该贯通开口的一端与柔性管5连接，另一端设置有连接器针6。在连接器2不与储器4连接的状态中，连接器针6延伸至一密闭室中，该密闭室包括分别由连接器2的圆筒形延伸部和弹性保护密封件7形成的壁。在连接状态中，保护密封件7被推向围绕连接器针6的连接器2内壁，并且在将连接器2与储器4连接时，连接器针6首先穿透保护密封件7，再穿透隔膜8，从而形成从连接器2到储器4内部的通道。在该实施例中，连接器2不可释放地固定在作为输送部3、4的整体部分的基板上。
图3示出了装置使用时从侧面看过去的图1实施例。基板10沿着患者的皮肤放置，并且例如通过粘附垫固定在患者身上。插管9在注射部1下面从基板近侧伸出，并且注射部被外壳部覆盖。输送部3、4固定在注射器1旁边的基板10远侧，并且也由外壳部覆盖。
基板10通常将在近侧通过粘附部和层固定在患者身上，但是可以使用任何类型的使基板粘在患者身上而不允许装置移动的安装件。该粘附部和层可以通过胶、维可牢尼龙搭扣、模制和类似物固定在基板10上。
在优选实施例中，输送部通过嵌在基板10中的一个和多个磁铁固定在基板10的远侧。可拆卸的输送部具有在使用时保持输送部在适当位置的相应磁铁。借助于基板10和/或输送部3、4的磁铁，将可以检测到系统的状态，例如输送部是否正确固定、穿过装置的流动是否良好、输送部已经固定在基板上多长时间、已经经过装置的体积大小等等。
图4示出了处于分离状态的第一实施例，其中可以看见在其上固定注射部1的基板10、用于将输送部固定在基部10上的物体11和基板的柔性部12。为了使输送部固定在基部10上，将输送部3、4从上面朝着基部10向下推。柔性部12由两个薄连接件构成，该两个薄连接件形成为直线并且通过去掉基部10平面的一些材料制成。基部10的这种构造连同柔性管5一起使得即使基部10上固定有输送部的部分被接触或推动或者仅仅由于使用者的活动而移动，连接在插管9上的注射部1也能保持在静止位置。
图5示出了图4的第一实施例的一部分的放大图。图5更详细地示出了插管9如何通过注射部1保持在适当的位置；注射部1如何经由柔性管5与连接器2连接。与输送部位于基部10同侧地固定在基部10上的连接器2以透明形式示出，这使得可以看见连接器针6。连接器2优选由PP、ABS或类似材料制成。
在图1-5中描述的第一实施例中，输送部3、4和注射部1之间的其中一个柔性区由柔性管5形成。该柔性管可以制造成一段挤压管，并且可以由PUR(聚亚安酯)、PP(聚丙烯)、PE(聚乙烯)、硅树脂、或者任何其它具有合适柔性或可以例如通过给管提供褶皱而形成柔性形式的材料制成。
与注射部1整体成形且不可释放地固定在基部10上的插管9可以在插入器的帮助下或者手动插入皮下。
输送部3、4的外壳由相对硬的材料例如PP或ABS(聚(丙烯腈、丁二烯、苯乙烯))制成，这使得外壳可以抵抗环境的冲击。
图6A示出了从面向注射部的一侧看过去的根据本发明的用于输送流体的装置的第二实施例。图6B示出了从穿过线B-B的装置切割部看过去的同一实施例。图7示出了通过连接器2将注射部1与输送部3、4连接的实施例的一部分放大图。在图6A、6B和7中，输送部和注射部同时连接在基板10上，这是装置在使用时的状态。
在第二实施例中，注射部1通过柔性管5与输送部3、4连接，其中在该实施例中柔性管5形成为波纹管且优选由硅树脂、PUR、PP/PE或类似材料制成。基部10的柔性部12形成为相对薄的V形连接件，该V形连接件通过去掉基部10平面的一些材料制成。柔性部12也可以由另外的材料例如TPE构成。该实施例具有滑动导轨11，其作为将输送部3、4固定在基部10上的物体。在该实施例中，连接器针6固定在输送部3、4上。连接器针6在输送部与连接器2接合时穿透隔膜8并因此形成从储器4至插管9的流动通道。
图8A和8B示出了处于输送部3、4与基部10分离使得可以看见两个滑动导轨11的状态的实施例。
在图8B中示出了图8A的连接器2的放大图。在该实施例中，连接器2包括由非柔性材料制成的具有贯通开口的模制部，其中该贯通开口的一端与柔性管5连接，另一端设置有隔膜8。柔性管5的柔性可以通过使用柔软且易曲的材料来实现，但是在该实施例中管5的柔性是通过构造由稳定(即非常坚硬)的波纹材料制成的柔性管5来实现。储器5具有连接器针6和保护连接器针6并且可以具有保护密封件(图8B中未示出)的圆筒形延伸部。在连接器2不与储器4连接的状态下，连接器针6延伸至一密闭室中，该密闭室包括由储器4的圆筒形延伸部和可选的弹性保护密封件形成的壁。在该连接状态下，如果存在保护密封件，该保护密封件将被推向围绕连接器针6的储器4内壁，并且当连接器2与储器4连接时，连接器针6首先穿透保护密封件，再穿透隔膜8，从而形成从储器4至连接器2内部的通道。在该实施例中，连接器2不可释放地固定在作为输送部3、4的整体部分的基板10上。
图9、10A和10B也示出了根据本发明第二实施例的装置。图9示出了输送部3、基部1和注射部1，以及它们如何在就要接合之前彼此相对地布置，并且箭头指出了输送装置3、4固定在基部10的物体11上以形成与注射部1的连接时的移动方向。图10A示出了从不同角度看过去的图8A的同一实施例，同时图10B示出了图10A中实施例的标记有圆圈的连接器2的放大图。在该实施例中，插管9从注射装置横向伸出，并且已经垂直插入使用者的皮肤。如果插管9由柔软且易曲的材料制成，则有必要使用插入针穿透使用者的皮肤。这可以通过为装置提供突出穿过插管9的近端开口的插入针来手动完成。尖插入针从插管9的近端引出，并且例如穿过覆盖插管9的远端开口的隔膜进入插管的远端，或者穿过侧面进入插管。在插入针穿过侧面进入插管9的情况下，有必要为进入位置提供一些密封件，从而在插入后取走插入针时防止微生物进入装置。装置的该实施例可以插有例如从2005年12月9日提交的PCT申请no.DK2005/050010中已知的插入器。如果插管从注射部的近侧伸出，它可能例如已经插有从2002年9月27日提交的PCT申请DK02/00640中已知的插入器。
图11示出了输送部3、4设置在注射部1顶部的实施例。在该实施例中，输送部可释放地固定在围绕注射部1的一部分基部10上。设置在注射部周围的基部的柔性部12形成为圆形折叠材料，该圆形折叠材料是更薄形式的与注射部的中心部相同的材料或者是具有更柔软或更易曲性质的不同材料。在图11中，输送部3、4和注射部接合在一起，就像它们在装置处于使用状态时那样，并形成了允许流体从储器流至插管9的连接。左右型式(version)示出了分别沿线D-D和E-E垂直穿过装置的两个不同切割部的视图。在该实施例中，用于将输送部3、4固定在注射部上的物体11形成为从基部10竖直伸出且具有向外突出件的圆形轮廓，物体11与输送部上的相应突出件13配合。当要使输送部3、4固定在注射部1上时，将两个把手部14推在一起使得相应突出件向外运动并允许注射部进入输送部3、4的中心孔中。当使用者松开把手部14时，相应部件回到更中心的位置并且将注射部1锁定在输送部3、4的中心孔中。
输送部3、4与连接器2结合在一起；连接器2具有贯通的连接器针6并且受弹簧15的影响。当使用者将输送部3、4推向注射部1时，弹簧15被压缩，同时贯通的连接器针6被迫使穿过保护储器内物质不受微生物感染的隔膜8a。同时或在这之前或之后，连接器针6也将被迫使穿过防止进入插管9的隔膜8b从而在未示出的储器和插管9之间形成流体连接。应当通过选择适宜用于弹簧15、隔膜8a的材料和其它与连接器2接触的材料，来确保在连接器2和输送部3、4之间存在柔性连接。优选的是在由输送部3、4的中心延伸部的壁引导从一个位置到另一个位置的运动的同时，连接器2被固定在弹簧15上，并且隔膜8a由柔软得足以确保连接器2在装置处于连接状态时能够柔性地连接在输送部3、4上的材料制成。在该实施例中，连接器2不是必须固定在输送部3、4上或注射部1上，连接器2可以是起独立界面作用的单独单元，或者它可以与输送部3、4或注射部1整体成形。
在图12中，示出了处于注射部1与输送部3、4分离的状态的图11实施例，其中输送部3、4使弹簧15处于松弛和延长的状态。在这种状态下贯通的连接器针6既不穿透输送部3、4的隔膜8a也不穿透注射部1的隔膜8b。
图13示出了三维形式的图11和12实施例。从侧面示出了输送部3、4和接合在基部10上的注射部1，这两个部件在接合时在这两个侧面彼此对应。
图11-13中示出的实施例可以插有从2002年9月27日提交的PCT申请DK02/00640中已知的插入器。在插入注射部1之后，使用者将基部10固定在皮肤上。随着注射部1位于适当的位置，使用者于是可以将包括至少一个储器和优选为泵形式的传送装置的输送部固定在注射部1上。如果连接器2是独立界面的形式，则应当在输送部3、4固定在注射部上之前放置该连接器，并且该连接器随后将在被选注射部1和被选输送部3、4之间提供正确的配合。
引入如图1-13中所描述和要求保护的柔性区时，将可以在由被使用部件的尺寸限定的确定边界内的所有方向上移动可释放的输送部3、4，如同将可以在不影响插管9和干扰插入部位的情况下拉动、推动、提升和移动输送部3、4，而插管9被影响和插入部位被干扰通常将使患者不舒服。
所有实施例都需要固定在患者皮肤上，并且如果实施例没有基部10，则优选通过施加粘附在基部10近侧或注射部1近侧上的安装垫来实现。安装垫在基部10或注射部1上的粘附可以包括胶、维可牢尼龙搭扣、模制等。
图14示出了一个实施例，根据该实施例可以确保从输送部3、4中的储器到注射部1的插管9并由此到患者的流体密封输送。
在图14中“A”示出了从侧面看过去的三维形式的包括输送部3、4和注射部1的装置，“B”示出了从下面看过去的三维形式的输送部3、4，同时“C”示出了从上面看过去的三维形式的注射部1。
图15示出了图14中的同一实施例，并且是沿线V-V的切割部的侧视图。在图15中，输送部3、4和注射部是分离的，并且连接器针6由向下的隔膜8B保护，防止细菌从该端进入储器。保护储器入口的隔膜8a被连接器针6的另一端穿透。在图15中示出，储器4设置在连接器针6上方，同时储器盖4a设置在储器4上方。例如在必须更换构成储器4的安瓿时，可以移去储器盖4a。在该实施例中，储器4具有柔性壁并且被环6围绕，通过该环6可以减小储器的容积并因此减小从储器4泵送至患者的流体。在该实施例中注射部1也具有用于将输送部3、4固定在注射部上的物体11，物体11形成为从基部10竖直伸出且与注射部1的外壳外表面成一体的圆形轮廓。物体11的向外突出件与输送部3、4上的相应突出件13配合。当要使输送部3、4固定在插入部1上时，将两个把手部14推在一起，迫使相应突出件13向外并允许注射部1进入输送部3、4的中心孔。当使用者松开把手部4时，相应部件13回到更中心的位置并将注射部1锁定在输送部3、4的中心孔中。
图16示出了图14和15中的同一实施例，但是在图16中输送部3、4和注射部1如同它们在使用中那样接合在一起。在该位置中，连接器针6已经穿透所有三个隔膜8a、8b和8c，并且已经在储器4和注射部1之间形成流体连接。
图17示出了根据本发明的装置实施例的分解视图，该装置包括输送部3、4的储器和注射部1之间的第二流体密封连接。该实施例包括输送部、第一弹簧15、上密封件17、下密封件18、第二弹簧19、注射部1、插管9、插入针20和安装垫21，其中输送部包括泵3和储器。进一步，输送部3、4的向外表面具有凹槽24，同时注射部1的向外表面具有相应的榫舌25。
在图18中示出了图17中实施例的单独部件如何在一起工作。在该图中示出了注射部和输送部3、4的内部。示出了储器4和储器4的出口管22在输送部3、4中的可能布置。在出口端，即图18中的最低端，出口管22具有横向指向的开口和密封件，其中该密封件确保注射部1的中心部的壁和出口管22的出口之间的流体密封接触。注射部1的内部包括贯通的流体通道23，流体通道23具有横向穿过注射部1的中心部的竖直壁的进口开口。
在第一位置，包括储器4和泵3的输送部从注射部1缩回，第一弹簧15被拉伸，同时出口管22的出口被注射部1的中心部的壁堵住。下密封件18处于高位置，在该位置它堵住流体通道23的进口，同时第二弹簧19被拉伸。
在第二位置，输送部3、4被推向注射部1，同时第一弹簧15和第二弹簧19都被压缩。在第一位置起阻挡细菌作用的下密封件18被输送部3、4的下边缘推向下并因此打开流体通道23的进口。当注射部1的榫舌25接触输送部3、4的凹槽24上侧时，输送部停止向下运动，并且在该位置出口管22的开口与流体通道23的进口对应。
图19示出了根据本发明的装置的另一个实施例，其能够确保储器和注射部1之间的流体密封连接。该装置包括例如图1-10中所示的输送部3、4，但是在图19中只示出了储器4。该装置由出口被泡沫状可变形膜26覆盖的储器构造成；膜在输送部不与注射部1接合时防止微生物进入储器。膜是泡沫状的意味着膜不具有平的内和外表面相反具有凸的内和外表面，以及膜不仅覆盖连接器针6的尖端而且覆盖连接器针6的较大部分。注射部1的进口也被泡沫状可变形膜27覆盖。在该实施例中，连接器针6固定在注射部1上，但是连接器针6也可以固定在输送部3、4上，如果连接器针6固定在输送部上则有必要为该组合装置提供两个针：连接器针6和插管9。如果该装置具有与插管9分开的连接器针6则可以使用软插管。
图19A示出了装置的三维视图，其中该装置处于输送部3、4和注射部1分离且流体不能在这两个部件之间流动的状态。图19B示出了处于与图19A相同状态的装置，但是是从穿过装置的竖直切割部看过去的。在图19C中，输送部3、4和注射部1已经被推在一起并且储器4的流体现在可以穿过注射部1和插管9流至患者。当两个膜被推在一起时，膜变形同时尖的连接器针6穿透两个膜形成流体连接，可以使各个泡沫状膜26和27形成为具有不同的硬度，从而通过利用不同的硬度在最小变形膜推靠最大变形膜时形成最小变形膜基底来控制在哪里穿透膜是理想的。
膜26和27可以由硅树脂或聚亚安酯(PUR)或针可以穿透但微生物不可以穿透的其它软聚合体制成。
连接器针6由相对硬的材料例如金属或硬聚合体制成，“相对硬的材料”意为该材料应当至少具有穿透膜26和27的强度，即硬得足以穿透膜26和27。
在图19A、B和C的实施例中，连接器针6是单针的一端，单针的另一端起插管9的作用。当连接器针6和插管形成为一个针时，该针通常将由金属或硬聚合体制成，但是也可以由例如在连接器端硬化而在插管端未硬化且柔软的聚合体制成。同样该单针也可以由两种不同的材料组成，硬质材料用于连接器端，相对柔软的材料用于插管端。
也可以将连接器针6和插管9分开，制造具有两个针的根据本发明的装置。于是注射部1可以具有普遍公知的软插管和连接器针6，其中该软插管可以在附接于单独插入器的插入针的帮助下插入，连接器针6由硬质材料制成且固定在注射部1或输送部3、4上。
在该实施例中，单针是弯的，即连接器针6指向与患者皮肤平行的方向，而插管9指向与患者皮肤垂直的方向。根据本发明，连接器针6可以指向与患者平行或远离患者的任何方向，并且插管9可以指向任何方向，只要插管可以插入患者皮肤。
根据本发明的装置可以与所有类型的药物和患者可以受益于连续药品输入的所有类型的条件结合使用。优选的是希望为糖尿病患者提供安全且容易操作的装置，该装置可以为患者提供连续调节的胰岛素剂量。
在优选实施例中，储器分为多个单独的室，每个室都装有不同的药品，或者例如在一个室中装有活性药物质同时在另一个室中装有溶剂，不同的室可以装不同浓度的药或具有不同活性物质的药。
图20-25示出了本发明的一个实施例，其中连接器2已经设置在基板10的中心位置，并且注射部固定在基板10的周边部。注射部的周边布置使得使用者可以观察到注射部位。进一步，该实施例的注射部排列成插管要以相对于基板10的远表面偏离90°的角度A注射，通常角度A将在110°和170°之间，其中基板10的远表面形成该角度的一边，同时插入的插管形成该角度的另一边。
在该实施例中，柔性部12由基板10构成并形成为如同轮中的四个轮辐。柔性部12的柔性可以通过改变柔性部12的宽度、基板材料10的厚度和柔性部12(轮辐)的数量来改变。
注射部是一个两部分单元，该两部分单元包括不可释放地固定在基板10上的第一部1a和包括插管9的第二部1b，该插管局部形成患者和储器4之间的流体连接。
可以应用至少两个不同的方法将该实施例定位在患者皮肤上。根据一个方法，首先将包括第一部1a的基板10定位在患者皮肤上，而后例如使用特别适合的插入器插入注射部1的保持插管的第二部1b，该方法使得使用者可以在定位通常配置有粘附垫的基板10时更加小心。根据第二个方法，利用适于保持整个装置的插入器将包括第一部1a和保持插管的第二部1b的基板10一起插入，该方法相比前述方法少了安装步骤。
在该实施例中，第一部1a具有向内突出部1c并且第二部1b具有向外突出的可枢转固定的钩1d。当第二部1b位于第一部1a中时，向外突出钩1d首先被向内突出部1c向外推动，并且突出钩1d在经过突出部1c后回到它们原来的位置并将第一部1a锁定在第二部1a的内部。
基板10具有三个竖直设置的用于将输送部3、4固定在基板10上的物体11；物体11的数量是任选的，并且物体11可以与基板10模制在一起或者在已经形成基板10后例如通过胶接或焊接固定在基板10上。物体11具有滑动凹槽11a，在将输送部3、4固定在基板10上时滑动凹槽11a限定输送部3、4的移动方向。滑动凹槽11a与输送部3、4上的突出部11b对应。在该实施例中，滑动凹槽11a不与基板10的表面平行，而是成一角度B：0°＜B＜45°，其中角度B的一边是基板10的远表面，角度B的另一边是滑动凹槽11a的远边。角度B-连同输送部3、4的圆形形状和连接器2的中心定位-使得可以将输送部3、4旋拧在基板10上。
连接器2由不可释放地固定在基板10上的模制体构成并且具有内隔室，隔膜7防止进入该内隔室。当输送部3、4固定在基板10上时，隔膜7被连接器针6穿透。孔5a允许流体从内隔室底部进入柔性管5并通过插管9流至患者。柔性管5与注射部的第一部1a连接，并且当注射部的第二部1b位于第一部1a中时，从柔性管5至插管9形成流体通道。
所示实施例的储器4通常将装0.5-3ml用于输给患者的流体。
图26-29示出了本发明的一个实施例，其中连接器针6直接插入注射部1，即没有单独的连接部。注射部1设置在基板10的中心位置，因此使用者不可能观察到注射部位。
在该实施例中，柔性部12也由基板10构成并且形成为类似轮中的四个轮辐。
注射部1是一个单元，该单元包括具有内隔室的模制体。当包括储器4的输送部3位于正确的位置时，可以通过连接器针6穿过保护密封件7进入内隔室。流体可以从内隔室通过插管9引导出。
基板10象图20-25的实施例一样，具有三个竖直设置的用于将输送部3、4固定在基板10上的物体11；物体11的数量是任选的。
在图26-29的实施例中，基板10放置在患者皮肤上，与此同时插入注射部1的插管9，并且插管9以90°的角度插入。为了插入该装置可以使用EP1 429 826中所示类型的插入器。
图30-32示出了本发明的一个实施例，该实施例与图26-29的实施例一样没有单独的连接器。注射部设置在基板10的中心位置，因此使用者不可能观察到注射部位。
在该实施例中，柔性部12也由基板10构成并且形成为类似轮中的四个轮辐。
注射部是一个两部分单元，该两部分单元包括不可释放地固定在基板10上的第一部1a和包括插管9的第二部1b。根据该实施例，首先将基板10放置在患者皮肤上，而后在指定位置插入注射部1的插管保持部1b。象图20-25中所示实施例那样，该实施例的第一部1a具有向内突出部1c，并且第二部1b具有向外突出且可枢转固定的钩1d，钩1d的相应部可以将第二部1b锁定在预期位置。
图33-36示出了本发明的一个实施例，其中注射部1固定在基板10的周边部，从该位置可以进行倾斜注射并因此使得使用者可以观察到注射部位。在该实施例中，注射部1是两部分形式，该两部分形式包括不可释放地固定在基板10上的第一部1a和包括插管9的第二部1b。第一部1a具有向内突出部1c，并且第二部1b具有向外突出且可枢转固定的钩1d。
该实施例的柔性部12也由基板10构成，但是在这里柔性部12形成为类似格栅。根据该实施例，也可以通过改变柔性部12的宽度、基板材料10的厚度和柔性部即条12的数量来改变柔性部12的柔性。
基板10具有两个竖直设置的用于将输送部3、4固定在基板10上的物体11；物体11的数量是任选的，并且物体11可以与基板10模制在一起或者在已经形成基板10后例如通过胶接或焊接固定在基板10上。物体11具有滑动凹槽11a，在将输送部3、4固定在基板10上时滑动凹槽11a限定输送部3、4的移动方向。在该实施例中，每个物体11都具有两个滑动凹槽11a，并且每个滑动凹槽11a都倾斜角度B：0°＜B＜90°。滑动凹槽11a与输送部3、4上的突出部11b对应。基板10的滑动凹槽11a和输送部3的突出部11b之间的相互作用确保了连接器针6穿过注射部1b的保护密封件7的正确插入，这是因为在将输送部3固定于基板10上的时候输送部3沿着限定得很好的路径移动。
通常当注射部1由两部分单元1a、1b构成时，用于将装置固定在患者皮肤上的方法将包括以下步骤：
-如果基板10具有例如不可释放地结合在粘附垫上的粘附表面，例如通过取下释放衬垫露出基板10的粘附侧，
-将包括一部分注射部1a的基板10放置在患者皮肤上，
-通常通过使用插入装置将注射部1b的第二部插入由第一部1a限定的位置，其中插入装置可以是多用途插入装置或单一用途插入装置，
-将输送部3放置在基板10顶部。
Claims (25)
1.一种用于输送流体的装置，包括注射部和流体输送部(3、4)，流体输送部和注射部可以被分开并重新接合，流体输送部包括储器(4)、例如泵形式的传送装置和外壳(3)，并且注射部包括：
-基板(10)，
-包括带有贯通开口的主体的插管部(1、1b)，其具有延伸经过基板(10)的近侧的插管(9)，和
-用于将基板固定在使用者皮肤上的构件(21)，
其特征在于输送部(3、4)和注射部通过连接器(2)装配，连接器(2)包括引导流体从储器(4)流至插管部(1、1b)中的贯通开口的流体通道，该流体通道包括用于在连接器(2)从输送部(3、4)和/或注射部上拆下时阻止进入注射部的构件(7、8、8b、8c)。
2.根据权利要求1所述的装置，其特征在于所述装置包括用于在连接器(2)与输送部分开时阻止进入输送部的构件(8，8a)。
3.根据权利要求1或2所述的装置，其特征在于基板(10)具有固定构件(11)，用于连接和拆下从基板(10)的远侧延伸出的输送装置(3、4)。
4.根据权利要求1-3所述的装置，其特征在于流体通道由可以被针状物体穿透的膜(7、8、8b、8c)阻塞。
5.根据权利要求1所述的装置，其特征在于输送部和注射部具有至少两个彼此相关的位置，即第一位置和第二位置，在第一位置，储器(4)的出口用微生物不能透过的第一屏障(8、8a、26)阻塞，并且注射部(1)主体中的贯通开口的进口用微生物不能透过的第二屏障(7、8b、18、27)阻塞，在第二位置，通过穿过第一和第二屏障而在储器(4)和注射部(1)中的贯通开口之间形成开放的流体连接。
6.根据权利要求5所述的装置，其特征在于一个或同时两个屏障(8、8a、26、7、8b、27)包括可以被针状物体穿透的材料，其中在针状物体缩回时所述贯通开口闭合。
7.根据权利要求6所述的装置，其特征在于针状物体是钝的。
8.根据权利要求6所述的装置，其特征在于针状物体是尖头的。
9.根据权利要求5所述的装置，其特征在于一个或同时两个屏障(18)包括硬表面，该硬表面在一个位置形成位于出口管(22)的出口和贯通的流体通道(23)的进口之间的区域的开口，在另一个位置闭合贯通的流体通道(23)。
10.根据权利要求1-9所述的装置，其特征在于注射部和输送部(3、4)通过一个或多个柔性区(5、12)彼此连接。
11.根据权利要求1-10所述的装置，其特征在于连接器(2)通过一个或多个非柔性区与一个部件连接，同时通过一个或多个柔性区(5)与另一个部件连接。
12.根据权利要求11所述的装置，其特征在于连接器(2)通过柔性区(5)与注射部(1)连接。
13.根据权利要求10-12所述的装置，其特征在于至少一个柔性区(5、12)由缩减了材料尺寸的区域构成。
14.根据权利要求10-12所述的装置，其特征在于至少一个柔性区(5、12)由较柔软和较易曲的材料制成的区域构成。
15.根据权利要求10-12所述的装置，其特征在于至少一个柔性区(5、12)由一区域构成，该区域由通过其形式而具有延伸和压缩能力的材料制成，例如被打褶或折叠的材料。
16.根据权利要求1-10或12-15所述的装置，其特征在于没有非柔性区域使注射部和输送部(3、4)相互连接。
17.根据权利要求1-16所述的装置，其特征在于该装置包括固定在患者皮肤上的相对平的基部(10)，输送部(3、4)固定在基部(10)的第一部上，注射部(1)固定在基部(10)的第二部上，一个或多个柔性区(12)设置在基部(10)的第一部和第二部之间。
18.根据权利要求17所述的装置，其特征在于输送部(3、4)可释放地固定在基部(10)上。
19.根据权利要求17所述的装置，其特征在于连接器(2)不可释放地固定在基部(10)上。
20.根据权利要求17所述的装置，其特征在于连接器(2)固定在基部(10)的第一部上。
21.根据权利要求17所述的装置，其特征在于连接器(2)利用非柔性连接不可释放地固定在基部(10)的第一部上。
22.根据权利要求17所述的装置，其特征在于柔性区(5、12)包括基部(10)上将第一部与第二部分开的区域(12)和将连接器(2)与注射部(1)连接的流体连接件(5)。
23.根据权利要求1-22所述的装置，其特征在于至少一个插管(9)具有从注射部的主体的近侧伸出的近端。
24.根据权利要求1-22所述的装置，其特征在于至少一个插管(9)具有从注射部的主体的侧面伸出的近端。
25.根据权利要求1-24所述的装置，其特征在于该装置通过施加粘附在基部(10)的近侧和/或注射部(1)的近侧上的安装垫固定在患者皮肤上。
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- 2006-12-22 EP EP09157468.1A patent/EP2130560B1/en not_active Revoked
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| CN102548598A (zh) * | 2009-08-07 | 2012-07-04 | 犹诺医药有限公司 | 具有传感器和一个或多个插管的传送装置 |
| CN102548598B (zh) * | 2009-08-07 | 2014-09-17 | 犹诺医药有限公司 | 具有传感器和一个或多个插管的传送装置 |
| CN106029122A (zh) * | 2013-12-20 | 2016-10-12 | 赛诺菲-安万特德国有限公司 | 具有一次性药筒和一次性注射器的药物输送装置 |
| CN113950341A (zh) * | 2019-05-20 | 2022-01-18 | 优诺医疗有限公司 | 可旋转的输注装置及其方法 |
| CN113950341B (zh) * | 2019-05-20 | 2024-03-19 | 优诺医疗有限公司 | 可旋转的输注装置及其方法 |
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