CN101163513B - 连接器系统 - Google Patents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61M25/00—Catheters; Hollow probes
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- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
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- A—HUMAN NECESSITIES
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- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
- A61M2005/1581—Right-angle needle-type devices
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
- A61M2005/1585—Needle inserters
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
- A61M2005/1587—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body suitable for being connected to an infusion line after insertion into a patient
Abstract
本发明涉及到一种注射座或连接器或者包括此种注射座或连接器的系统。在一种形式中本发明涉及一种包括用于皮下注射流体的插入装置和连接器的系统,该连接器包括对应于与插入装置一体形成的近端表面(1b)的远端表面(1a)。在另一形式中本发明涉及一种用于皮下注射流体的连接器,该连接器包括:带有至少一个穿透开口(6)和至少一个插管(3)的主体(1),该穿透开口带有入口和出口,且至少一个插管具有从主体的下侧突出的近端;并且在穿透开口的入口处,药剂可由输送装置(20)注射,该输送装置具有形成具有直径di的内开口的突出部件(22);其中入口的表面成形为使得入口的顶部的横截面,即从入口的顶部到顶部下方di/3位置处,不超过di。
Description
技术领域
本发明涉及到一种注射座或连接器或者包括此种注射座或连接器的系统。连接器布置于使用者皮下,而可以替代采用针筒或注射管的反复注射,这样就减少了对患者皮肤的创伤并同时使注射部位免于被感染。
背景技术
已知这样的一种连接器。在早先的文献中公开的注射针组件包括一个连接器和一个笔式注射器,通过该组件就可以使用钝头的针进行皮下注射或静脉注射。这些文献中并没有说明如何插入连接器。因为当穿透隔膜时针头的导引或指引很小并且同时硬管体非常短时,皮下注射针头穿透软插管侧部的风险相当大,因此在这种连接器中甚至不可能使用较短、较尖锐的针头进行注射。
已知的还有其他类型的连接器,例如包括细长管体的连接器,该管体具有从管的一端在纵向上延伸至相反端的内通道。插管连接到该管体并从通道的远端延伸。插管通过套管的方式与管体连接,紧邻插管的近端是自密封的硅薄膜。薄膜以插头的方式与套管的后端相接合。这样就只有最小的死区,即管体的通道内的内容积。这种连接器具有相对较长的硬管部,从而减小了尖锐的针头刺穿插管的风险,但是连接器必须以一个较低的角度手动插入。在插入之后,连接器几乎与患者的皮肤平行放置,这种平行的位置使患者自己难以通过该连接器注射药物。
本发明的目的是提供一种连接器,其使患者易于自行放置和自己施用药物或其他药剂。还有一个目的是当患者实际上不注射药物时,使连接器在置放于患者皮肤上之后尽可能的不显眼。
发明内容
根据本发明,一种用于皮下注射流体的注射用连接器,该连接器包括:带有穿透开口的主体;不可拆卸地附装到该主体的安装衬垫,其具有粘结表面;至少一个插管和至少一个穿透部件,该穿透部件具有从主体的下侧突出的近端;置于穿透开口内的插管的远端处的隔膜;其中隔膜限制了至插管的通路,因此可以通过能够刺穿隔膜的药物输送装置到达插管。连接器可拆卸地与插入部中的偏压单元相连接,其中该插入部可以在拆卸时将连接器从后缩位置移到前向位置。
通过将连接器置于注射器内从而使连接器为注射做好准备,这样确保不熟练的使用者可以在无菌环境下正确地放置皮下连接器。正确的放置连接器对于完全由操作者控制的输药过程是很重要的。可选地注射器可以是例如WO03/026728(insetTM)中公开的一次性注射器。在注射后,连接器通过安装衬垫固定在患者身上,由于连接器主体的光滑表面和高度较低,该连接器不太可能挂到任何东西。连接器具有光滑表面是指主体附近尤其是在其靠近安装衬垫的边缘处没有凸出部、开口和尖角。保持表面光滑一般可能会导致的一个问题是在插入过程中该单元必需可靠紧固于插入装置之内,但这个问题根据本发明已被解决。
“插管”用于从连接器主体凸出的空心部件;插管插入患者身体并引导药液从连接器内部进入患者体内。当插管采用诸如金属或硬塑料的硬材料制成时,其可以作为穿透部件使用,此种情况下插管和穿透部件是同一部件。优选地,注射用连接器的插管采用软材料制成,因为与硬插管相比,软插管与皮肤组织兼容性更好。此种情况下需要有一个例如尖针头的能够在患者皮肤上划开口的单独的穿透部件,其为插管的插入做好准备,在插管插入后穿透部件被移除,而插管留在患者皮肤上作为传输药物的通道。还优选的是形式是插入针头的穿透部件不可拆卸地紧固于插入装置上并在插管内延伸并超出该插管,此种情况下插入针头将和插入装置一起被移除,而使用者不必在移除了插入装置后再移除单独的针头或针头单元。
在本发明的一个实施例中,多于一个的插管和/或穿透部件从连接器的主体的下侧突出。
有一种情况是单个的穿透部件用一组仅凸出几毫米的较短穿透部件代替,这些较短穿透部件从连接器主体内的一个共用腔室供应药物。
还有一种情况是连接器与例如测量血液中葡萄糖含量的测量单元一起使用。当用作可以同时施用药物的连续测量装置时,患者需要插入一个探针,其给测量装置提供通入血液的通道。探针可以与插管一起插入,通过此插管注射药液,或者探针可以通过另外一个穿透部件在另外一个位置被插入。在一个优选的实施例中,连接器可作为测量装置的基座使用,该测量装置例如是Abbotts Diabetes Care出品的NavigatorTM。
优选地,注射用连接器可以带有一个引导部,其在连接装置被插入时便于使用者通过连接器进行注射。这对于视力不好的患者或者在连接器被置于患者难以看见针头入口的患者身体部位情况下是一个显著的优点。
根据本发明,引导部既可以被放置于穿透开口内也可以被放置在连接器主体的远端表面上。
如果引导部被放置在远端表面上,引导部可以具有轨道的形式,该轨道可以是相对于表面的凸起和/或凹陷。优选地轨道形成为插入装置的一部分的相对凹部,该部分优选形成为注射管的注射端。
在一个优选实施例中,轨道形成为一个或多个凹陷,优选为形成环状,这样就允许了注射管具有遮盖针头的延长侧,从而当注射管不进行注射时保护使用者不被针头刺伤。
在一个优选实施例中,引导部的可拆卸部分在药物输送装置与连接器之间形成独特的转接装置,从而确保了只可能使用一个给定的注射装置。“独特的转接装置”指两个互相面对的表面,即如同手与手套的对应关系一样的相互对应的连接器的表面与药物输送装置的表面。这具有如下的优点,即对特定的药物使用给定的注射器,这使患者几乎不可能注射非开处方给患者的药物。此外,在输送装置和连接器之间产生非常紧密的配合的转接装置使得死区最小,死区即是连接器主体内注射药物保持未用状态的内部体积。在另一个优选的实施例中引导部的至少一部分可拆卸地紧固到主体,从而使该可拆卸部作为药物输送装置和连接器之间的可交换对接装置。
注射用连接器可以可拆卸的方式紧固到位于插入部件中的滑动部件,其中滑动部件不可拆卸地紧固到偏压单元。
优选为将注射用连接器紧固到与偏压单元不同的滑动部件的原因在于,与将连接器直接与偏压单元相连的方式相比,因为偏压单元具有对偏压单元的设计有要求的已规定目的,所以更简单的是将连接器与用于在偏压单元和连接器之间形成连接的单元相连。滑动部件可以是一种非常简单的结构,它使仅仅通过将插入针头不可拆卸地附装到滑动部件并将插入针头插入连接器的插管,就将连接器充分地与滑动部件紧固成为可能。仅插入针头和插管之间的摩擦阻力就保持连接器在插入过程之中处于正确的位置上。
优选地,与连接器的主体相接触的插入部件的近侧成形为与连接器非常对应的形状。插入部成形为与连接器部件相对应是指与连接器紧邻的插入部的端部紧紧跟随连接器的表面并且在滑动部件与连接器之间产生尽可能大的接触。此大的接触确保了通过插入装置更精确-从而也较无痛的插入,使得连接器可被更精确地操作。
优选地,插入部与连接器邻近的端成形为注射管端,并且连接器的表面形成有对应的轨道。很多连接器使用者愿意采用注射管来进行药物注射,因为插入较容易并且易掌握正确用药量。将与连接器相邻的滑动部件的表面成形为注射管具有这样的效果,即在连接器表面中形成的轨道将同样好地适合于滑动部件和注射管。
为了在附装到使用者时保护好注射用连接器,在由使用者执行的多次插入过程之间,可以在主体的顶端上定位与连接器相对应的封盖。
特别地,注射用连接器可应用于胰岛素的使用上,通过使用注射用连接器就使例如替代胰岛素泵的使用成为可能。胰岛素泵通过连接于与患者紧固的输入部件的软管来给患者提供稳定的胰岛素给药量,但是此种泵较昂贵并且-至少周期地-因为在身体上携带该装置和连接管而给患者造成不便。
本发明还涉及到一种包括用于皮下注射流体的插入装置和连接器的系统,其中所述连接器包括带有至少一个穿透开口的主体、至少一个插管以及设置在至少一个插管的远端或设置在至少一个穿透开口中的微生物限制部件;并且所述系统包括至少一个穿透部件,所述穿透部件具有从主体的下侧突出的近端;待注射的药物通过药物输送装置输送到所述连接器,所述药物输送装置能够通过微生物限制部件,所述连接器可拆卸地连接到插入装置中的偏压单元,其中所述偏压单元在拆卸时能将连接装置从后缩位置移到前向位置,其中连接器的主体包括对应于与插入装置形成一体的近端表面的远端表面。
“形成一体”意味着近端表面可以构成插入装置的内表面或是指近端表面可以由以可拆卸或不可拆卸方式紧固于插入装置内部的部件组成。在一个优选实施例中,与输送装置形成一体的近端表面属于一个单独的对接装置。在此种应用中,词语“转接装置”和“对接装置”可以互换使用。
本发明还涉及到一种包括插入装置、连接器和对接装置的系统,其中所述连接器包括带有至少一个穿透开口的主体、至少一个插管以及设置在至少一个插管的远端或设置在至少一个穿透开口中的微生物限制部件;并且所述系统包括至少一个穿透部件,所述穿透部件具有从主体的下侧突出的近端;待注射的药物通过药物输送装置输送到所述连接器,所述药物输送装置能够通过微生物限制部件,所述连接器可拆卸地连接到插入装置中的偏压单元,其中所述偏压单元在拆卸时能将连接装置从后缩位置移到前向位置,其中,所述对接装置设有对应于插入装置的远端表面和对应于连接器的近端表面。
本发明还涉及到一种系统,包括药物输送装置和用于皮下注射流体的连接器,其中所述连接器包括带有至少一个穿透开口的主体、至少一个插管以及设置在至少一个插管的远端或设置在至少一个穿透开口中的微生物限制部件;并且所述系统包括至少一个穿透部件,所述穿透部件具有从主体的下侧突出的近端;待注射的药物通过药物输送装置输送到所述连接器,所述药物输送装置能够通过微生物限制部件,所述连接器可拆卸地连接到插入装置中的偏压单元,其中所述偏压单元在拆卸时能将连接装置从后缩位置移到前向位置,其中,所述系统还包括单独的对接装置,所述对接装置包括与连接器的远端表面相对应的近端表面和与输送装置的近端表面相对应的远端表面。
本发明还涉及到一种系统,包括插入装置、药物输送装置和用于皮下注射流体的连接器,其中所述连接器包括带有至少一个穿透开口的主体、至少一个插管以及设置在至少一个插管的远端或设置在至少一个穿透开口中的微生物限制部件;并且所述系统包括至少一个穿透部件,所述穿透部件具有从主体的下侧突出的近端;待注射的药物通过药物输送装置输送到所述连接器,所述药物输送装置能够通过微生物限制部件,所述连接器可拆卸地连接到插入装置中的偏压单元,其中所述偏压单元在拆卸时能将连接装置从后缩位置移到前向位置,其中,所述连接器包括远端表面,所述远端表面对应于与插入装置形成一体的近端表面和与输送装置形成一体的近端表面。优选地,所述连接器包括与对接装置的近端表面相对应的远端表面,并且所述对接装置具有与输送装置的近端表面相对应的远端表面。
这些系统的优点是在使用整个系统时,可以组合多个生产相对便宜的标准单元与例如药物专用装置,该药物专用装置更加昂贵但是可以确保例如当使用者必须对他/他自身进行给药时不出错。另外,自行给药也鼓励个人参与他们自身的卫生保健并提供常规的体检和讲授药物知识的结构。
在一个优选实施例中,连接器的远端表面包括由插入开口内的一个或多个部件构成的引导部,所述一个或多个部件由相对较硬的材料制成,例如金属或硬塑料或与主体相同的材料。
在一个优选实施例中,引导部的至少一部分可以从主体分离,并且优选地,该引导部成形在单独的插座中,该插座在使用前紧固于连接器的主体。同样在一个优选实施例中,对接装置包括注射针头。
在一个优选实施例中,引导部可从主体部分离的部分作为用于给定的药物输送装置的转接装置。
根据本发明,一个独立的转接装置可以固定于输送装置上。优选地,独立转接装置可以从覆盖注射针头的一个位置移至注射针头不被覆盖的第二位置。
本发明还涉及到一种系统,其包括药物输送装置,所述药物输送装置具有固定到转接装置的插入针头,其中,所述转接装置的不固定到药物输送装置的一端设置有至少一个封盖,以绕插入针头提供受保护和无菌的环境。优选地,所述药物输送装置在准备好使用状态下填充好药物。
本发明还涉及到一种用于流体的皮下注射的连接器,所述连接器包括:
-带有至少一个穿透开口和至少一个插管的主体,所述穿透开口带有入口和出口,并且所述至少一个插管布置成与所述穿透开口成流体连通关系并具有从主体的下侧突出的近端;
-并且在穿透开口的入口处,药剂可由输送装置注射,所述输送装置具有在向连接器输送药剂时覆盖入口的突出部件,所述突出部件形成具有直径di的内开口;
其特征在于:所述入口的表面成形为使得所述入口的顶部的横截面,即从入口的顶部到顶部下方di/3位置处,不超过di。优选地,所述顶部的表面构造成球的一部分。或者,顶部的表面由多个互相以大于90℃的角度相连的较小的平面表面组成,从而形成连贯、凸起的表面(多面)。
在一个优选实施例中,连接器具有至少两个穿透开口。优选地,穿透开口中的至少一个具有无法被尖锐插入针头刺穿的壁,所述插入针头与用于插入针头的入口相对放置。
优选地,隔膜可从穿透开口的入口移开或者被穿破以便进入穿透开口。
附图说明
现在将参照附图来描述本发明的实施例,附图中:
图1是连接器的分解图。
图2是与图1相同实施例的剖面图。
图3A和3B以分解图的方式示出了图1和2的连接器的插入装置的实施例。
图4示出了根据本发明的连接器的第二实施例,其中连接器配有一个封盖。
图5示出了连接器以及注射针头的第二实施例。
图6A示出了连接器以及深轨道和相应注射针头的第三实施例。
图6B示出了在图6A实施例的连接器的主体中的两种可能的轨道图案。
图7示出了根据本发明的连接器的第四实施例,其中连接器配置有浅轨道。
图8示出了根据本发明的连接器的第五实施例,其中连接器的主体的表面完全光滑。
图9示出了根据本发明的连接器的第六实施例,其中连接器同时配置有内引导部和外引导部。
图10示出了根据本发明的插入部的第二实施例。
图11示出了图10中连接器的插入装置的一个实施例。
图12示出了用于无注射针头的药物输送装置的对接装置的一个实施例。
图13和14示出了根据本发明的具有两个穿透开口的连接器的实施例。
图15示出了具有一个用于钝针头的入口的连接器的实施例。
图16示出了根据本发明的具有两个穿透开口的连接器的另外一个实施例。
图17示出了入口的顶部的横截面积不超过di的连接器的实施例。
图18示出了入口的顶部的横截面积不超过di的连接器的实施例,该实施方式也较容易保持干净。
图19示出了定位在输送装置和连接器之间的两个单独的转接装置。
图20示出了与输送装置形成为一体的转接装置的实施例,其中转接装置具有两个位置A和B。
图21示出了与输送装置形成为一体的转接装置的另外一个实施例,其中转接装置具有两个位置A和B。
图22示出了定位在输送装置和连接器中的所选插座36之间的所选转接装置的实施例。
图23示出了定位在输送装置和连接器中的所选插座36之间的所选转接装置的另外一个实施例。
图24示出了用于预填充针筒的转接装置或对接装置。
具体实施方式
在图1中示出了连接器的分解图。该连接器包括带有光滑远端表面的主体1,其中该远端表面是在连接器插入后背向患者方向的表面,同时在主体1的近侧布置一个安装衬垫2,该衬垫具有一个与患者相邻的粘结表面。该近侧是在连接器插入后朝向患者的一侧。主体1具有一个穿透开口6,其中布置从主体1的近侧延伸的插管3。在插管的远端,其直径增大从而造成在插管这端形成一个小腔室7,该腔室作为流体通过隔膜注射的沉积处。在穿透开口6中也布置一个用来限制到开口6的通道的隔膜4,这是由于为隔膜4所选材料的特性使得在移走针头后由针头在隔膜4中产生的开口将闭合。必须采用较硬的针头刺穿隔膜,但是针头不一定要很尖锐。较硬是指针头要比隔膜4的材料硬,针头不一定用钢制造;其可以采用例如硬塑料材料制造。在EP1191964中公开了如何制造这种针头。在穿透开口6的远端,也即是注射针头进入开口6的那端布置一个引导部5;该引导部5由较硬的材料制成,从而使得针头较容易刺入穿透开口中的正确位置。该引导部由一种相对较硬的材料制成是指引导部5应该不会被注射针头刺穿,其所使用的材料的硬度取决于注射针头所使用的材料。能够防止被一般使用的尖针头刺注射穿的材料有硬塑料或金属,但是如果注射针头是钝的,那么也可以使用例如橡胶这样的较软材料。
图2示出了图1中所示同一实施例的连接器的剖面图。在该图中,安装衬垫2邻接于主体1放置。插管3放置在开口6的近端;在腔室7上方与插管相邻放置隔膜4。引导部5放置在隔膜和主体的外远端表面之间。在此图中可以看到引导部5是如何引导针头刺入隔膜4的相反侧上的正确位置,并且确保注射流体存放于腔室7中。
图3A和3B示出了根据本发明可以使用的插入装置。该插入装置包括一个壳体10,在该实施例中壳体10包括2个紧固部件11,它们确保内部组件13不会相对壳体转动。壳体还包括一个形式为两个突出部的保持部件12,其用来将内部组件13保持在偏压位置,直到采用某种释放装置来将内部组件13从偏压位置释放为止。内部组件13由中心部14和环绕部15构成。中心部14作为手指抓取部,环绕部15用作偏压单元。中心部14可以在相对壳体10的前向和后缩位置之间滑动,而连接器的主体1与中心部14相紧固。环绕部15由两个形成为几乎半圆的部件组成,其中每个半圆部的一端附装到壳体10中的紧固部件11之一,每个半圆部的另外一端通过连接壁16紧固于中心部14。半圆部的在紧固部件11处紧固到壳体10的一端在使用时相对于壳体不移动。在中心部14被拉出壳体10(图3B中的箭头方向)时,半圆部的附装到带有手指抓取部的中心部14的另一端将会相对壳体10移动。当拉动中心部14时,作为偏压部件的环绕部15会被拉紧。环绕部15由两个突出部17保持在偏压位置上。此实施例中的突出部17附装到连接壁16,但也可以附装到中心部14。当中心部14被拉出壳体10时,突出部17会被拉着通过保持部件12,并且这些部件会阻止突出部17并由此也阻止中心部14回到位于壳体10内的松弛位置。
因为壳体具有一定的柔性,因此可以通过在与由两个保持部件12形成的直线垂直的直线方向上(图3A和3B的箭头表示方向)对壳体的两侧施加压力来释放偏压位置。当在此位置对此两相反侧施压时,其所导致的壳体的变形会使两个保持部件12相互推离对方,从而给突出部17经过保持部件12以及偏压单元15迫使中心部14回到松弛位置留出了足够的空间。
连接器的主体1定位于中心部14的近端。在图3A和3B示出的实施例中,与连接器主体1相接合的装置18具有圆顶形状。连接器的主体1配置为其远侧装配到圆顶18中。主体1的近侧用安装衬垫2覆盖,当主体1被紧固于插入装置10、13时,至少一个插入针头通过该安装衬垫2从近侧突出,所述插入针头附装到中心部14或连接器的主体。如果插入针头附装到插入装置10、13,则主体1配置有优选用软材料制成的插管3。
当使用者需要该注射用连接器时,连接器被放置在插入装置之中并且对整个单元消毒。当单元消毒之后需要给壳体10在其近端和远端均配置一个可移除的封盖。偏压单元15处于松弛状态时,这意味着当插入针头从近侧突出并需要不会被消毒针头刺穿的合适封盖时,内部组件13完全被壳体10所覆盖,该封盖优选为较硬封盖。
当使用者准备插入连接器时,使用者首先移除壳体10远端和近端的两个封盖,如果安装衬垫2被一个释放衬里覆盖的话,再移除该安装衬垫2的释放衬里。然后使用者抓取中心部14的手指抓取部并将中心部14沿着中心部14的轴线方向拉出壳体。使用者一直拉动直到突出部17经过保持部件12并会听到咔哒声。此后使用者松开手指使得中心部14处于拉紧位置。现在注射用连接器被放置在患者的皮肤上,通过在壳体10的侧部上轻微挤压而释放偏压单元15。在壳体10上使用者为了释放偏压单元而需要挤压的具体位置上,用颜色或图案标记出来。
当偏压单元被释放时,中心部14移回到壳体内的松弛位置,并且因为插入针头从处于松弛位置的壳体上突出,所以插入针头刺入患者的皮肤。当插入针头已经刺入患者的皮肤时,插入装置10、13与连接器的主体1分离并被移除。如果插入针头附装到中心部14,则插入针头将会与插入装置10、13一起被移除,但是如果插入针头附装到连接器的主体,则插入针头会保持插入状态并作为插管使用。
其他不同于此处描述的插入装置也可以与根据本发明的连接器一起使用,但是其必须使连接器的主体能够与插入装置相配合插入并且能够通过防止其转动而将其保持就位,一直到进行注射。这可能是困难的,因为连接器优选具有一个非常光滑的远端表面。这与用于输液套件的插入装置是相反的,因为输液套件包括两部分:包括插入患者皮肤的插管的一个输液部、以及一个连接部。因为输液套件的输液部的远端表面的至少一部分配置有将输液部紧固于连接部的部件,因此输液部总是配置有将装置紧固于插入装置内部的部件。
在前面所描述的插入装置10、13中,连接器的主体1由插入针头和插管之间的摩擦阻力保持在插入装置10、13之中,但还有其他在插入过程中将连接器的主体1保持于插入装置中的方法,例如在插入装置10、13与连接器之间采用粘合剂,或者将连接器按压进由插入装置10、13的部件形成的一个限制空间之内。为了确保在不必操作者将连接器拉离插入装置的情况下能够将连接器与插入装置10、13拆开,插入装置10、13和连接器之间的粘力应该比插入的连接器的安装衬垫和患者皮肤之间的粘力要小。
本发明特别地涉及到相对短而尖的针头的使用,例如在针管注射或是钝针注射中常规使用的针头。对这两种类型的针头,引导部5甚至对于无任何经验的使用者都确保找到进入穿透开口6的入口。引导部5可以是置于开口6中极小的一个单元,并且与主体1的远端表面平齐。此种情况下,主体1的远端表面可以制造为没有任何凸出或凹陷的完全光滑,这是一个优点,因为非常重要的是当患者在移动时主体1不会无意地刺到或是挂到任何东西。或者,引导部5可以以与注射用的针头单元相对应的轨道的形式成形于主体1的外部。此种引导部5的形式具有如下优点,因为外部的引导部5确保了在通过连接器给患者输药时只有一种方式来放置注射针头,因此使注射非常容易并且安全。
如果采用钝针头来注射药物,那么隔膜4最好具有一个预先成形的孔以使钝针头能够穿过,尽管这依赖于制造隔膜4的材料。如果插入针头是不可拆卸地紧固于插入装置10、13之上,那么当插入装置10、13和附装到其的插入针头在注射后被移走时,在隔膜4种将会形成一个预成形孔。
图4示出了一个剖开的连接器。在该实施例中,引导部5成形为主体1的中心部件,其由几个竖直的部件构成或由一个整体的优选为环形部件构成,该环形部件从一个与患者皮肤大致平行的平面延伸。为了使连接器在与患者相接触时不会触到其他东西,连接器上设置一个封盖19。该封盖为连接器的主体1提供一个光滑的表面,并且该封盖19还能作为对接装置或转接装置使用,如果患者想使用不同类型的针头单元,封盖19可以成形为一个不完全遮盖住主体的穿透开口6的环或者在开口6的至少一部分上设置可穿透材料。
图5示出了与图4中相同的连接器,但是其中的封盖19被从连接器上移走并且连接器准备好输药注射。药物由一个带有尖锐注射针头21的注射器20注射。在此实施例中,注射针头相对于注射器的前部后缩。注射器的前部包括一个或多个突出部件22,这些部件保护四周在注射前后不被尖针头刺到并且还与引导部5相对应。因为当引导部5和突出部件22必须配合在一起时,注射针头只能被放置在正确的位置上,因此引导部5和突出部件22之间相对应的关系确保了注射的便利与安全。
图6A示出了一个连接器,其中引导部5成形为一个在主体1的远端表面上的环形的凹陷或布置成环的多个孔。图6B显示了两种可能的凹陷的图案,其中形成引导部5的凹陷示出在上面。
图7示出了另外一种连接器,其中引导部5的凹陷较浅,针头单元20的突出部件22受一个或多个弹簧单元23控制。当处于松弛位置时,弹簧单元将突出部件22向下推,并在此位置上保护周围部件不与针头接触。当使用者想注射流体到连接器中时,带有突出部件22的针头单元20放置于引导部5之中并被向下推,这就使得突出部件22部分地消失到弹簧单元23所在的空间中。当被向下推时,注射针头21延伸超出突出部件22,针头21会刺穿隔膜4从而流体传输到插管3。
图8示出了连接器的一个实施例,其中突出部件22成形为圆顶形并且引导部5是主体1的光滑的远端表面。该实施例同样在突出部件22之上设置有弹簧23。因为没有直接通到尖针头21的通道,这就使注射前后对针头单元20的使用更安全。
图9示出了一个实施例,其中引导部5既放置在开口6的内部又形成为主体1的竖直壁。引导部5还可以由不同的部件和可能的不同材料制成,因为限定引导部5的形状部分由主体1的远端表面的竖直壁的表面构成,部分由放置在穿透开口6内的内部元件8的预表面构成。
图9还示出了圆形的对接或转接装置9。这些对接装置9可以放置在主体1的竖直中心部的顶部之上,并使得可以在使用同一连接器的同时使用不同的针头或针头系统。
图10示出了连接器的另外一个实施例。在此实施例中,主体1的穿透开口6在连接器插入后几乎平行于患者皮肤放置。根据本发明的连接器可以以从大约0°或假定连接器在注射后所保持的角度到大约90°的角度插入。不论从什么角度注射连接器,在注射完成后其都要被放下在近侧上并由安装衬垫2固定到皮肤。
图11示出了适用于图10所示出的连接器的实施例的插入部的一个实施例。该实施例包括壳体10、偏压单元15以及可以在前向位置和后缩位置之间滑动的中心部14。在图11中,中心部14在前向位置中,且偏压单元15是松弛的。中心部14配置有保持部件12,当中心部14处于其中偏压单元15被压紧的后缩位置时,保持部件12会抵靠壳体19的上侧(“上侧”指如图11中所示的壳体10的上侧)的内侧上的一个凸起。同时中心部14配置有用于与连接器1的主体相接合的装置18。
优选地,根据该实施例的连接器系统在偏压单元15处于压紧状态的情况下发送到使用者,此时中心部14处于后缩位置。当使用者准备插入连接器时,首先移除保持连接器装置无菌状态的封盖,然后移除安装衬垫2的释放衬里,如果安装衬底2由释放衬里覆盖的话。随后使用者将插入部的前端以期望的插入角度抵靠皮肤。然后使用者沿着图11标记的箭头方向推动释放装置。该释放装置推下保持部件12并释放偏压单元15。中心部14和连接器被推向前,在该处插入针头刺入患者皮肤并插入插管3。在插入插管3后,插入部被从连接器上移走而将安装衬垫2固定于皮肤上。
在图12A和12B中示出了连接器的一个实施例,其具有两个可能的注射位置:第一注射位置是从可以使用如图5所示药物输送装置的顶部,而第二注射位置是穿过形成引导部5的壁。
在图12A中,连接器的保护封盖被移走,连接器准备从顶部进行注射。在图12B中,封盖由一个对接装置代替,此对接装置使得可以使用没有注射针头的药物输送装置。对接装置30包括带有围绕竖直针头31的直壁的引导部5a,所述针头能够刺穿药物输送装置中的隔膜。药物流体从针头31流经管道32,该流体经过配置有密封环33的连接器的主体的壁中的开口,并穿过插管3的侧壁中的开口34而进入插管3。为了确保对接装置30的正确定位,连接器的主体的壁设有其侧壁35在图12A中示出的一个凹陷。
图13和14示出了一个连接器的实施例,其中,如图12的实施例一样,其具有两个可能的注射位置:第一注射位置40位于主体1的中心顶部处,在该处可以使用带有一个短尖针头(一般最大3mm)的药物输送装置;第二注射位置50位于连接器主体1的外周顶壁处,在该处可以使用带有长尖针头的药物输送装置,对针头无最大限制。
图13示出从上方注射的实施例,其中第一注射位置40处于中心,并包括围绕中心开口46的较硬的引导部45。第二注射位置50包括一个具有较大面积的隔膜54,其可被一个长尖针头在任何位置刺穿。
图14示出了图13的实施例的剖面图。当流体通过第一注射位置40被注射时,短注射针头插入开口46并刺穿第一注射位置的隔膜44,从而药物被注射入插管3和位于隔膜44下方的空间47中。因为用于注射药物的针头较短,因此使用该针头刺穿插管3的壁的风险很小。当流体通过第二注射位置50被注射时,注射针头通过刺穿第二注射位置的隔膜54而被插入,药物填满空间57并通过一个通道流入位于隔膜44下方的插管3。不论隔膜54被刺穿的位置如何,当针头完全插入时,用于注射药物的尖针头满足连接器主体1的材料的硬度要求时,则插入针头的长短就不重要了,因为插入长度由位于隔膜54下方空间的深度所限定。
图15示出了连接器的剖视图,其中隔膜4由两段组成,上段4a和下段4b,这两段4a和4b可以模制成为一个整体单元或者模制为一起装配在主体1中形成的穿透开口中的两个单元。在此实施例中,在隔膜的上段4a中形成一个预切开口4c,其方便在将药物输送至连接器时采用钝的插入针头21。由于隔膜4是压入装配到主体1中的,所以预切开口通过压缩保持于一个封闭位置。当要进行输药时,输送装置的钝针头21被施力通过预切开口4c直到钝针头21遇到隔膜的下段4b的斜壁为止,然后药物输送至插管3处并填充隔膜4内至少一部分空间。
图16示出了连接器的一个实施例的剖面图,其中可采用两种不同的输送装置。图16示出了带有圆筒形隔膜4的连接器的中心部,所述隔膜与O形环4d一起阻塞主体1的穿透开口,在该实施例中该穿透开口被分成两条流体通道6a和6b。O形环4d定位于成形于主体1中的环形槽中。
在图16B中示出了使用钝注射针头21来将药物输送至连接器的方式。插入针头21对侧面开口,当向着隔膜4推动该针头时,插入针头21对隔膜4施压从而使其产生变形。这样的变形就使得流体能够从插入针头21流入通道6b,流体从通道6b可以流至插管(未示出)。O形环4d确保了在流体从插入针头21流出时,没有流体流经注射针头21和连接器的主体1之间。
在图16C中示出了使用尖注射针头21来将药物输送至连接器的方式。插入针头21在尖锐端开口,当向着隔膜4推动该针头时,针头刺穿隔膜顶部从而允许流体从插入针头21流入通道6a,流体从该通道可以流入插管(未示出)。O形环4d确保了在流体从尖插入针头21流出时不会在隔膜4和连接器主体1之间回流。
图17示出了一个连接器预备好进行药物注射的实施例。药物采用一个配有尖注射针头21的注射器20进行注射。在此实施例中注射针头相对注射器的前部后缩。注射器的前部包括一个或多个突出部件22,这些部件在注射前后保护四周不被尖针头刺到,并与引导部5相对应。因为当引导部5和突出部件22必须装配到一起时,注射针头只能被放置在正确的位置上,因此引导部5和突出部件22之间相对应的关系确保了注射的便利与安全。在该实施例中,配置在主体1上的引导部5和隔膜4部分地成形为一个球,该球的直径与注射装置的突出部件22之间的内距di接近相对应。这种形状使得注射装置20能够从绕连接器主体任何水平方向即360°引导至正确的位置,尽管注射装置20偏离垂直方向高达大约45°。
图18示出了一个在安装于患者皮肤上时易于保持清洁和便于进行清洁的连接器的实施例。该连接器的主体1形成有凸起的侧部,该侧部部分地保护凸起的中心部,并且同时为在主体1的凸起侧部和竖直壁5之间以及竖直壁5与隔膜4所环绕的顶部之间的边缘提供清洁空间,中心部的顶部优选为球形。
图19A和B示出了对接装置30的两个实施例,这样一种对接装置用于布置在连接器和输送装置之间。图19A示出的第一对接装置包括尖插入针头21,该尖插入针头21不可拆卸地紧固到对接装置30上并且具有一个可以刺穿连接器(未示出)中的隔膜的尖锐近端21a、以及一个可以刺穿输送装置20中的隔膜的尖锐远端21b。图19B中所示第二对接装置不包括尖插入针头21,该对接装置30与具有一个尖插入针头21的输送装置20一起使用。
图20A和B示出了对接装置30的另外一个实施例。对接装置30的此实施例不可拆卸地紧固到输送装置20上,并且对接装置30具有两个固定位置,如图20A示出的后缩位置和如图20B示出的前向位置。如果输送装置20用于给不带引导部5的标准连接器添加药剂,则当从输送装置20向连接器输药时,对接装置30处于图20A中的后缩位置。如果输送装置20用于向例如图5或17中所示的带有引导部5的连接器添加药剂,则当从输送装置20向连接器输药时,对接装置30处于图20B中的前向位置。
图21A和B示出了带有突出部件22的改进针头的一个实施例。突出部件22具有两个位置,如图21A中示出的中心位置和图21B中示出的远端位置。改进针头首先安装在处于正常位置的注射器上,同时突出部件22处于远端位置(B),然后注射器填入药剂。在填充注射器后,移动突出部件22至遮盖住针头的中心位置(A),从而可以将药剂注射入例如图5或17所示的带引导部5的连接器。
图22示出了对接装置30的另外一个实施例。该对接装置30的实施例用于使标准输送装置20与连接器的主体1进行配合,所述连接器配有置于连接器主体1的插座36中的可拆卸的引导部5。插座36在使用前被推入到主体1中同时发出咔哒声确认到达正确位置。
当从来源例如药瓶向患者输送药物时,输送装置20首先从未示出的来源填满,在填充过程中输送装置20不受对接装置的保护。在填满输送装置20后,对接装置30或者位于输送装置20上或者位于由可拆卸的引导部5形成的插座36之中。当给患者输药时,输送装置20插入对接装置30中,当输送装置20插入对接装置30中时,插入针头21刺穿封盖到插管3的入口的保护隔膜4,从而药物可以被注射入位于插管3上方的空间7中并流到患者血流中。
图23还示出了对接装置30的另外一个实施例。该对接装置30的实施例用于使标准输送装置20与连接器的主体1配合,所述连接器配有置于连接器主体1的插座36中的可拆卸的引导部5。
与图22中的实施例相比,对接装置30的此实施例具有较短的臂接到输送装置20。
图24示出了用于预填充注射器的对接装置30的实施例。该对接装置30的实施例在使用前与一个标准的输送装置30相连接。包括预填充的输送装置20的此系统以图24中示出的形式输送到使用者,输送装置20被预填充是指当包括有药物的输送装置20在准备好使用状态下交给使用者时,使用者不必亲自填充输送装置20,其中所述准备好使用状态包括药物处于准备好使用状态并且该装置的针头段已消毒。当使用者准备采用该预填充输送装置20来注射药剂时,首先要移开封盖部件4a,然后将输送装置20定位或连接于连接器或其他准备接收药物的装置上,然后就可以注射药剂。一般输送装置20为注射器。
Claims (16)
1.一种用于皮下注射的系统,其特征在于:所述系统包括用于皮下注射流体的插入装置、药物输送装置(20)、独立的转接装置(9,30)和连接器,其中:
-所述插入装置(10,13)包括穿透部件并设有偏压单元(15),所述偏压单元(15)在拆卸时能将所述连接器从后缩位置移到前向位置;
-所述连接器包括带有至少一个穿透开口(6)的主体(1)、至少一个插管(3)以及设置在至少一个插管(3)的远端或设置在至少一个穿透开口(6)中的微生物限制部件(4);
-所述药物输送装置(20)能够通过所述微生物限制部件(4),以及
-所述独立的转接装置(9,30)包括与所述连接器的远端表面(1a)相对应的近端表面(1c)和与所述输送装置(20)的近端表面(1b)相对应的远端表面(1d)。
2.根据权利要求1所述的系统,其中,所述连接器的远端表面(1a)包括由插入所述穿透开口(6)内的一个或多个部件构成的引导部(5),所述一个或多个部件由相对较硬的材料制成。
3.根据权利要求2所述的系统,其中,所述引导部(5)包括轨道(5),所述轨道形成为与所述连接器的远端表面的主体相比凸起或凹陷的部件。
4.根据权利要求3所述的系统,其中,所述轨道(5)的形式为一个或多个凹陷。
5.根据权利要求3或4所述的系统,其中,所述引导部(5)的至少一部分能从主体(1)分离。
6.根据权利要求5所述的系统,其中,所述引导部(5)形成在单独的插座(36)中,所述插座在使用前紧固到所述连接器的主体(1)。
7.根据权利要求6所述的系统,其中,所述引导部(5)的能从主体(1)分离的部分作为用于给定的药物输送装置(20)的转接装置。
8.根据权利要求1所述的系统,其中,转接装置(30)包括注射针头(31)。
9.根据权利要求1所述的系统,其中,所述药物输送装置(20)包括注射针头(21),独立的转接装置(30)固定到所述输送装置(20)。
10.根据权利要求9所述的系统,其中,独立的转接装置(30)可以从覆盖注射针头(21)的一个位置移至注射针头(21)不被覆盖的第二位置。
11.根据权利要求1-4和7-10中任一项所述的系统,其中,所述连接器包括用于可拆卸连接测量血液中葡萄糖含量的传感器的装置。
12.根据权利要求1所述的系统,其中,插入装置(10,13)的与连接器的主体(1)相接触的部分成形为注射管端部。
13.根据权利要求1-4、7-10和12中任一项所述的系统,其中,在进行多次注射之间,相应的可移除的封盖(19)能定位在主体(1)的顶部上。
14.根据权利要求1-4、7-10和12中任一项所述的系统,其中,主体(1)由透明材料制成。
15.根据权利要求9所述的系统,其特征在于:转接装置(30)的不固定到药物输送装置(20)的一端设置有至少一个封盖(4a),以绕注射针头(21)提供受保护和无菌的环境。
16.根据权利要求15所述的系统,其特征在于:所述药物输送装置(20)在准备好使用状态下填充好药物。
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WO2008148714A1 (en) | 2007-06-06 | 2008-12-11 | Unomedical A/S | Packing allowing gas sterilisation |
AU2008266382B2 (en) | 2007-06-20 | 2013-06-27 | Unomedical A/S | A catheter and a method and an apparatus for making such catheter |
WO2008155377A1 (en) | 2007-06-20 | 2008-12-24 | Unomedical A/S | Cannula insertion device with automatic needle retraction comprising only one spring |
WO2009004026A1 (en) | 2007-07-03 | 2009-01-08 | Unomedical A/S | Inserter having bistable equilibrium states |
KR20100062991A (ko) | 2007-07-10 | 2010-06-10 | 우노메디컬 에이/에스 | 두 개의 스프링을 갖는 인서터 |
WO2009010396A1 (en) | 2007-07-18 | 2009-01-22 | Unomedical A/S | Insertion device with pivoting action |
AU2008277766A1 (en) | 2007-07-18 | 2009-01-22 | Unomedical A/S | Inserter device with controlled acceleration |
US20090204077A1 (en) | 2008-02-13 | 2009-08-13 | Hasted Soren B | Moulded Connection Between Cannula and Delivery Part |
CN101970033A (zh) | 2008-02-08 | 2011-02-09 | 优诺医疗有限公司 | 包括插入件、套管部和基部的组件 |
AU2009211319A1 (en) | 2008-02-08 | 2009-08-13 | Unomedical A/S | Inserter assembly |
CA2713485A1 (en) | 2008-02-13 | 2009-08-20 | Unomedical A/S | Sealing between a cannula part and a fluid path |
MX2010009087A (es) | 2008-02-20 | 2011-05-03 | Unomedical As | Dispositivo de insercion con parte horizontalmente movil. |
CA2715144A1 (en) | 2008-02-25 | 2009-09-03 | Unomedical A/S | Bubble shaped membrane and use of such membrane in a device |
CN102202636A (zh) | 2008-05-30 | 2011-09-28 | 优诺医疗有限公司 | 储器填充装置 |
MX2010014258A (es) | 2008-07-07 | 2011-03-21 | Unomedical As | Insertador para dispositivo transcutaneo. |
EP2296729A1 (en) | 2008-07-07 | 2011-03-23 | Unomedical A/S | Inserter for transcutaneous device |
-
2006
- 2006-02-22 US US11/908,776 patent/US7985199B2/en active Active
- 2006-02-23 CA CA002600953A patent/CA2600953A1/en not_active Abandoned
- 2006-02-23 MX MX2007011443A patent/MX2007011443A/es active IP Right Grant
- 2006-02-23 EP EP06706138A patent/EP1871446A2/en not_active Withdrawn
- 2006-02-23 WO PCT/DK2006/050005 patent/WO2006097111A2/en active Application Filing
- 2006-02-23 JP JP2008501162A patent/JP5118015B2/ja not_active Expired - Fee Related
- 2006-02-23 AU AU2006224945A patent/AU2006224945B2/en not_active Ceased
- 2006-02-23 CN CN2006800061526A patent/CN101163513B/zh active Active
- 2006-02-23 RU RU2007138509/14A patent/RU2397784C2/ru not_active IP Right Cessation
- 2006-02-23 KR KR1020077019314A patent/KR20070114721A/ko not_active Application Discontinuation
-
2007
- 2007-10-12 NO NO20075233A patent/NO20075233L/no not_active Application Discontinuation
Patent Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1558782A (zh) * | 2001-09-27 | 2004-12-29 | ��ŵҽ������˾ | 用于安置皮下输液器的注射器装置 |
Also Published As
Publication number | Publication date |
---|---|
AU2006224945A1 (en) | 2006-09-21 |
RU2007138509A (ru) | 2009-04-27 |
US7985199B2 (en) | 2011-07-26 |
WO2006097111A2 (en) | 2006-09-21 |
JP2008532663A (ja) | 2008-08-21 |
JP5118015B2 (ja) | 2013-01-16 |
WO2006097111A3 (en) | 2006-11-02 |
US20080215003A1 (en) | 2008-09-04 |
EP1871446A2 (en) | 2008-01-02 |
CN101163513A (zh) | 2008-04-16 |
MX2007011443A (es) | 2007-11-16 |
AU2006224945B2 (en) | 2009-07-23 |
NO20075233L (no) | 2007-10-12 |
RU2397784C2 (ru) | 2010-08-27 |
KR20070114721A (ko) | 2007-12-04 |
CA2600953A1 (en) | 2006-09-21 |
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