CN101365504A - 给药设备 - Google Patents
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- CN101365504A CN101365504A CNA2006800487552A CN200680048755A CN101365504A CN 101365504 A CN101365504 A CN 101365504A CN A2006800487552 A CNA2006800487552 A CN A2006800487552A CN 200680048755 A CN200680048755 A CN 200680048755A CN 101365504 A CN101365504 A CN 101365504A
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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
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
- A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
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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
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/10—Tube connectors; Tube couplings
- A61M39/12—Tube connectors; Tube couplings for joining a flexible tube to a rigid attachment
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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
- A61M5/142—Pressure infusion, e.g. using pumps
-
- 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
-
- 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
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
- A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
- A61M2005/14252—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type with needle insertion means
-
- 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
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
- A61M2005/14268—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body with a reusable and a disposable component
-
- 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
- A61M2005/1581—Right-angle needle-type devices
-
- 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
本申请涉及一种间歇地或连续地提供治疗物质例如胰岛素的装置,包括注射部分和流体输送部分(3、4)。所述流体输送部分通常包括储器(4)、例如泵形式的传送装置(3)和壳体,并且所述注射部分包括基板(10);插管部分(1,16),其包括具有将流体引导至插管(9)的贯穿开口的主体,其中插管(9)延伸超过基板(10)的近端侧;和将所述基板固定到用户的皮肤上的装置(21)。所述装置包括基板(10);插管部分(1,1b),其包括具有将流体引导至插管(9)的贯穿开口的主体,其中插管(9)延伸超过基板(10)的近端侧;和将所述基板固定到用户的皮肤上的装置(21),其中,在插管(9)的置于皮下的部分与流体输送部分(3、4)之间的区域内设置有柔性部分。
Description
技术领域
本发明涉及一种间歇地或持续地施用治疗物质例如胰岛素的设备,所述设备包括注射部分和流体输送部分。所述流体输送部分通常包括储器、例如泵的传送装置和壳体,并且注射部分通常包括基板,插管部分包括延伸超过基板近端侧的插管和用于将基板固定到用户皮肤上的装置。
背景技术
EP-A1-1.527.792和EP-A1-1.495.775均描述了一种医疗设备,其包括经皮进入单元和储器。所述经皮进入单元包括用于穿过受治疗者的皮肤部分传送流体的经皮进入装置,以及适用于应用到受治疗者皮肤上的安装表面。储器单元包括适用于包含流体药品的储器和允许经皮进入装置与储器内部流体连通地设置的出口。同时所述设备包括排出装置,例如泵,该装置在使用时将流体药品从储器排出并通过经皮进入装置穿过受治疗者的皮肤。经皮进入单元和储器单元进一步包括可释放配合的耦合装置,其允许所述储存单元在使用时被紧固到经皮进入单元上。本发明的目的是提供一种可以以一种方便的、节约成本的方式使用的可安装在皮肤上的药品输送设备或系统。
根据这篇文献,描述的实施例中的插入针(113,212或412)可枢转地设置在针壳体内部,并且其可以在伸出和回缩位置之间移动。当注射针被插入时,其穿透一层隔膜以穿透受治疗者的皮肤。在针被插入后,所述系统没有柔性效果。
US 2004/0204673 A1描述了一种质量较轻并且低成本的流体输送设备,该设备可以调整和计划流体的输送;所述设备包括围绕储存腔的壳体。分配器与储存腔流体连通以从储器分配有限量的流体。所述分配器由流体输送设备的电子微控制器控制。所述流体输送设备进一步包括连通元件,其用于接收来自遥控控制设备的信息,所述遥控控制设备未与本发明的流体输送设备机械连接。还包括与分配器流体连通的出口组件,所述液体药品从该出口离开流体输送设备并经皮进入哺乳类患者的身体中。
壳体702和802均可以由柔性材料制成,或可以设置有在患者移动时允许流体输送设备10弯曲的柔性铰链区域,从而防止分离并有利于患者舒适,但是该文献中未指明这种铰链区域应当如何构造。
发明内容
本发明的目的是提供一种用于输送流体的设备,所述设备包括泵、储器和注射部分,在使用时,该设备保证了佩带者承受较少的不适。根据本发明的设备构造有在输送部分受到触摸或移动影响时减小从相对较重的输送部分向注射部分的传送动作的装置。
根据权利要求1,本发明包括用于输送流体的设备,该设备包括注射部分和流体输送部分,其中所述流体输送部分包括储器、例如泵形式的传送装置和壳体,其中所述注射部分包括:基板;插管部分,包括具有将液体引导至插管的贯穿开口的主体,其中插管延伸超过基板的近端侧;和将所述基板固定到用户的皮肤上的装置,其中,在插管置于皮下的部分与流体输送部分之间的区域内设置有柔性部分。
其中一个部分是柔性的意味着它是具有弹性,能够在不断裂的情况下变形,它是非刚性的材料,但不完全是从一个位置移动到另一个位置的刚性材料,其具有一定程度的弹性,从而当柔性部分的一端承受外界影响因素如推力或拉力作用时,这些外界作用在插管被插入时不能直接被传递到插管上,但是这些作用被至少部分地吸收。柔性既可以是由材料特性所决定的,又可以是由材料的物理结构所决定,例如所述材料可以具有褶皱等。由于输送部分易于受到外界因素影响,如用户在来回走动时出现的推力或拉力作用,因此理想的是这些作用不被传递到穿过用户皮肤的插管上。所述柔性部分至少部分地吸收这些作用并且保证插管不会受到影响,即不会被拔出或四处移动从而引起用户的不适或疼痛。
根据一个实施例,所述柔性部分被集成在所述基板中,根据该实施例,所述基板部分地或全部地由柔性材料构成。
根据第二实施例,所述柔性部分被集成在所述插管部分的主体中,其中所述主体具有将液体引导至插管的贯穿开口,根据该实施例,所述插管部分的主体部分地或全部地由柔性材料构成。
根据第三实施例,所述柔性部分被集成到所述流体输送部分中。
根据第四实施例,所述柔性部分为设置在所述流体输送部分和所述注射部分之间的独立单元。根据该实施例,所述独立单元部分地或全部地由柔性材料构成。
所述插管部分和/或基板和/或独立单元部分地由柔性材料构成,意味着所述部分/板/单元的全部区域的一个小部分例如由不同的材料制成或由带有例如孔的结构制成,其中该结构在一个或多个维度上增加所述材料的弹性。如果所述部分/板/单元完全由柔性材料构成,材料的选择以及材料的尺寸,例如所述部分/板/单元的厚度和/或外周形状将决定其柔度。
对于上述每个单元来说,适当的柔性材料可以是弹性体。
当所述柔性部分是独立元件时,它在所述注射部分和输送部分之间形成交界面,从而提供柔性过渡,该柔性过渡提供了对于由所述流体输送装置的重量和体积产生的可传递的影响的吸收。
根据一个实施例,所述流体输送部分和所述注射部分可以被分离和重新接合。
根据一个实施例,所述基板具有紧固装置,其用于连接和断开由所述基板的远端侧伸出的所述输送装置。
根据一个实施例,所述流体输送部分的壳体还具有用于所述注射部分的壳体。
当所述流体输送部分提供壳体时,由于所述流体输送部分的壳体具有完全可拆卸的保护盖,因此可供用户视觉上检查完整的流体路径。同样也可以形成柔性的基板,从而不需要壳体和保护盖,壳体和保护盖将使基板不那么柔软。
根据一个实施例,柔性部分由具有减小材料尺寸的区域构成。“减小材料尺寸”既可以是厚度即材料“高度”的减小,也可以是横向部分即材料“宽度”的减小。
根据第二实施例,柔性部分由以更软的并且更具柔性/弹性的材料制成的区域构成。
根据第三实施例,柔性部分由这样一种材料制成的区域构成,其中所述材料因为其形状而具有延展和压缩能力,例如被打褶或折叠或波纹状的材料。
根据一个实施例,所述插管和所述输送部分不是通过非柔性区域互连的。
根据一个实施例,当所述输送部分和所述注射部分连接起来时,形成将来自所述储器的流体引导至所述插管的流体密封连接。
根据一个实施例,由于当所述流体输送部分与所述注射部分分离时,通向储器的开口被阻挡,因此在所述两个部分分离的期间内,可以防止微生物进入所述流体输送部分的所述储器。
根据一个实施例,所述储器具有两个位置,第一位置和第二位置,当处于第一位置时,储器的出口被微生物不可穿过的第一屏障阻挡,插管部分中的贯穿开口被微生物不可穿过的第二屏障阻挡,当处于第二位置时,通过穿过所述第一和第二屏障而在所述储器和所述插管部分的贯穿开口之间形成打开的流体连接。根据该实施例,所述屏障中的一个或两个包括可被针状物体穿透的材料,其中当所述针状物体缩回时,所述开口关闭。所述针状物体可以为钝头的或尖头的。一个或两个所述屏障可包括坚硬的表面,该表面被移动以便在设置于输出管的出口与所述贯穿流体通路之间的区域中形成开口。
根据一个实施例,用于将所述基板固定到用户的皮肤上的装置包括安装垫,该安装垫粘附在所述基板的近端侧和/或所述插管部分的近端侧。
根据一个实施例,所述基板具有带有外周粘接部分的格栅,和一个或多个与所述外周部分互连的连杆。所述基板具有圆形或椭圆形的外周部分,并且所述连杆具有连接到所述外周区域的一端和连接到中心区域的第二端。所述基板具有三个或更多个连杆。
根据一个实施例,所述基板在使用之前不具有插管保持部分,例如,所述基板具有开口,插管保持部分可经由该开口插入。
根据一个实施例,所述插管的一端具有一主体,该主体包括实心壁和保护密封件,以保护所述插管的流体入口。
根据一个实施例,包括基板的注射部分具有所述插管部分的第一部分,该第一部分用作第二部分的定位控制器,其中第二部分包括插管并且要被插有注射针。
所述插管插有一插入设备,该插入设备具有与所述基板的表面对应的装置,并且当所述插入设备的所述装置与所述基板的相应表面结合时,所述插入设备以这样的方式定位,即,例如包括主体的插管可相对于所述基板可预见地并且正确地插入。例如所述插管部分的第一部分装备有用于将所述第二部分锁定在理想位置的装置。
根据一个实施例,所述基板不可释放地连接到所述安装垫。
“储器”为保持液体的设备的一部分,所述液体是要在特定时间间隔内以特定量向患者输送的任何种类的药物。所述“输送部分”为保持液体储存并通过泵送和例如控制添加液体的量来保证液体传送至注射部分的设备的一部分。所述“注射部分”定义了一种固定到用户皮肤上的端口,并且其设置有例如用于将液体传送至用户的装置,例如插管,并且所述注射部分不包括任何较重的或体积大的部分。所述注射部分可以包括一个或多个独立部分,其中一个或多个部分不可释放地连接到基部上,并且所述一个或多个部分可以在将基板固定到患者的皮肤上之前或之后被紧固到基部上。
当柔性区域设置在相对较重的输送设备与注射设备之间时,从输送设备到注射部分的传递动作被阻止或至少显著的被降低,并且保护被设置在皮下的插管的注射部位不会受到由于推动或接触所述输送部分而引起的任何相互作用的主要部分的影响。通常输送部分通过相对长的管与注射部分物理上分离以防止动作的传递,但是当输送部分与注射部分设置在一起时,用户在佩戴根据本发明的设备时将会感到更少的不适。
通过使用连接器,可以避免输送部分与注射部分之间的直接作用,并且同时将两个部分作为一个单元而固定到患者的皮肤上。
所述插管可以从注射部分主体的近端侧或主体的侧面伸出。如果插管与图4和图7中示出的实施例相同而从主体的侧面伸出,则插管通常会被弯曲,并且优选地使用至少部分地由软的和柔性的材料制成的插管。如果所述插管从如图12所示的一样而从主体的近端侧伸出,则所述插管可以由较硬的材料如金属制成,或者其可以由软的和柔性的材料制成。
根据本发明,所述连接器针可以为单独的针的一端,而该单独的针的另一端用作插管。当连接器针与插管形成为一个针时,所述针通常由金属或硬聚合物制成,但是其也可以由例如在连接器端被硬化而在插管端未硬化和软的聚合物制成。同时所述单独的针可以由两种不同材料制成,较硬的材料用于连接器端,而相对比较柔软的材料用于插管端。同时连接器针与插管可以被分离成至少两个针。所述注射部分可以设置有公知的柔软插管,其中该柔软插管可以在被附接到独立插入器上的插入针的帮助下被插入,并且所述连接器针可以由较硬的材料制成并被紧固到注射部分或输送部分上。
所述柔性区域由具有减小的材料尺寸的区域构成,如可以在材料上设置开口或切口,或是减小材料的厚度,或者由更柔软更具柔性的材料制成的区域,或者其可以由这样一种材料制成的区域构成,其中所述材料因为其形状或结构而具有延展和压缩能力,例如被打褶或折叠的材料。
在非连接状态下,即当储器与注射部分分离时,因为在所述两个部分分离时通向储器的开口被阻挡,因此可以防止微生物进入所述储器。当例如连接器针被附接到输送设备上时,连接器的隔膜上的开口在去除连接器针时被关闭。
在另一个实施例中,输送部分的储器具有两个位置,第一位置和第二位置,当处于第一位置时,储器的出口被微生物不可穿过的第一屏障阻挡,插管部分中的贯穿开口被微生物不可穿过的第二屏障阻挡,当处于第二位置时,通过穿过所述第一和第二屏障而在所述储器和所述插管部分之间形成打开的流体连接。名词“穿过”包括所有使流动通过或绕过屏障的方法,在本发明描述的大部分实施例中,通过针穿透所述屏障而穿过屏障,但是还有一种示例(图18A和B),其中通过将盖推到旁边并因此形成流动通道而穿过所述屏障。
如果所述屏障包括可以被针状物体穿透的材料,其中当所述针状物体缩回时,所述开口关闭,其中所述针状物体为钝头的或尖头的,这意味着针状物体或者推进通过所述屏障或者切割通过所述屏障。
在另一个实施例中,至少一个屏障包括较硬的表面,即该表面不能被至少较钝的针穿透,所述较钝的针移动从而在输出管的出口和贯穿流体通道的入口之间的区域形成开口。
所述设备通常通过将安装垫应用到基部近端侧或输注部分的近端侧而紧固到患者的皮肤上,所述安装垫附着到基部或输注部分上的方法包括胶水、维可牢尼龙搭扣(Velcro)、模制等。
在一个实施例中,所述基部可以形成为格栅。所述外周部分可以形成有开口或形成为构成基部周边的连贯(coherent)部分。所述基部具有格栅形状意味着其由一个或更多的彼此互相连接的连杆形成,并且如果存在的话,还可以形成有外周部分。这种形式的基部可以很容易地具有理想的柔性,并且其可以是任何可能需要的理想形式,从而可以将注射部分和输送部分适配到被安装的设备上。
在一个实施例中,所述注射部分由至少两个独立的部分构成,其中第一部分不可释放地连接到基部上,而包括插管的第二部分在将基部安装到患者的皮肤上之前或之后被设置在第一部分上。注射部分的分割的优势在于其使得设备的应用更具有灵活性。所述第二部分可以包括相对小的主体,其中插管从远端侧伸出,隔膜保护其远端侧。所述第二部分可以例如与已经安装在插入器中的基部一起出售。
如果注射部分由多于一个独立部分构成,则第一部分可以具有将第二部分锁定在理想位置上的装置。同样,所述第二部分可以具有用于将第二部分锁定到第一部分上的理想位置的装置,或者第一和第二部分可以各自具有对应的锁定装置。
附图说明
下面将结合附图对本发明的实施例进行描述:
图1示出了从图3中示出的B-B直线上方看过去的本发明的第一实施例,其中所述输送部分设置在注射部分的旁边。
图2示出了图1的实施例中圆圈标出部分的放大视图。
图3示出了从指示直线B-B侧看去的实施例。
图4示出了输送部分与注射部分分离的第一实施例。
图5示出了图4中的实施例以圆圈标记的部分的放大视图。
图6A示出了从所述注射部分侧看去的本发明的第二实施例。
图6B示出了由线B-B截取的与图6A相同的实施例。
图7示出了图6B的实施例中中以圆圈标记的部分的放大视图。
图8A示出了与所述输送部分分离的第二实施例的注射部分和基部。
图8B示出了图8A的实施例中用圆圈标记的部分的放大视图。
图9示出了第二实施例的输送部分和注射部分。
图10A从不同的角度示出了与图8A相同的实施例。
图10B示出了在图10A的实施例中以圆圈标记的部分的放大视图。
图11示出了处于连接状态的本发明的输送装置的第三实施例,并且在该实施例中,所述输送部分设置在注射部分的顶部。
图12示出了处于分离状态的所述装置的第三实施例。
图13分别从上下两侧示出了所述第三实施例的两个部分。
图14示出了本发明的输送装置的第四实施例。“A”示出了从侧面看去的输送部分,其中注射部分准备好与所述输送部分连接,“B”示出了从后方看去的输送部分,“C”示出了从上方看去的注射部分。
图15示出了处于分离状态的从侧面(线V-V)看去的第四实施例。
图16示出了处于连接状态的从侧面(线V-V)看去的第四实施例。
图17示出了本发明的输送装置的第五实施例,其中在所述输送部分和注射部分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的部分,所述装置在第一位置关闭流体流动,在第二位置打开流体流动。
图19示出了确保流体从输送部分到注射部分的流体密封传送的另一个实施例。
图20示出了具有基部的第六实施例,所述基部备有中央连接器和外周注射部分。
图21示出了从上方和侧面看去的处于接合状态的第六实施例的输送装置和基部。
图22示出了处于接合状态的图21的第六实施例的剖视图。
图23示出了图22的连接器部分的放大图。
图24示出了图22的注射器部分的放大图。
图25示出了从下方看去的第六实施例的输送部分的视图。
图26示出了具有基部的第七实施例,所述基部备有中心结合的连接器和注射部分。
图27示出了从侧面和从上方看去的处于接合状态的第七实施例的输送部分和基部。
图28示出了图27的处于接合状态的第七实施例的剖视图,和结合的连接器/注射器部分的放大视图。
图29示出了从下方看去的第七实施例的输送部分的视图。
图30示出了具有基部的第八实施例,所述基部配有中心结合的连接器和注射器部分,其中所述结合的部分被划分为单元。
图31示出了示出了从上方和侧面看去的处于接合状态的第八实施例的输送部分和基部。
图32示出了处于接合状态的图31的第八实施例的剖视图和结合的连接器/注射部分的放大视图。
图33示出了具有椭圆形基部的第九实施例,所述基部配有中央连接器和外周注射器部分。
图34示出了从下方看去的处于分离状态的第九实施例的输送部分和基部,和从侧面看去的储器和基部。
图35示出了从侧面和上方看去的处于接合状态的第九实施例的输送部分和基部。
图36示出了处于图35的接合状态的第九实施例的剖视图,和所述注射部分的放大图。
图37示出了用于输送流体的装置的第十实施例,其包括注射部分和流体输送部分,在图37中,该两个部分以分离的状态示出。
图38示出了从上方看去的第十实施例的注射部分。
图39a和39b都示出了从下方看去的第十实施例的输送部分,在图39a中,所述注射部分不具有安装垫,并且所述输送部分被接合起来,在图39b中只示出了所述输送部分。
图40示出了所述注射部分的实施例,其具有用于在中心和外周布置的所述输送部分的紧固装置。
图41a-b示出了输送部分的壳体的不同实施例,其也用作注射部分的壳体。
具体实施方式
图1-3示出了根据本发明的设备的第一实施例,其中输送部分与注射部分彼此紧固。图1中的实施例为从图3中的B-B直线上方看过去的视图,并且图2示出了图1在放大形式下的一小部分。所述设备包括注射部分,所述注射部分包括图1中不可见的基板10、插管部分1和未示出的安装单元,该安装单元通常为安装垫。所述插管部分1包括主体,所述主体具有引导液体至插管9的贯穿开口,其中所述插管9在注射后被置于皮下。所述设备进一步包括连接器2和具有光滑盖3的输送部分,所述输送部分包括未示出的泵和储器4。柔性管5在注射部分与传送部分之间形成流体连接,并且连接器针6可以穿透保护密封件7和隔膜8以保证从输送部分到注射部分的流体路径,其中所述保护密封件7覆盖连接器2的入口,所述隔膜8覆盖储器入口。在图1-3中所述设备处于连接状态,其中所述注射部分与输送部分连接在一起并已经准备好使用。
图2示出了图1中的连接器2的放大视图。在这个实施例中,所述连接器2包括非柔性材料的模制部分,所述模制部分具有一端连接到柔性管5上而另一端上设置有连接器针6的贯穿开口。在连接器2未连接到所述储器4的状态下,所述连接器针6延伸入一个封闭室,所述封闭室包括分别由连接器2的圆筒形延伸部与弹性保护密封件7形成的壁。在连接状态中,所述保护密封件7向着围绕连接器针6的连接器2的内壁被推动,并且在将连接器2连接到储器7上时,所述连接器针6首先穿透保护密封件7并随后穿透隔膜8,以形成从连接器2到储器4的内部的通路。在这个实施例中,所述连接器2被不可释放地紧固到基板10上,其中所述基板10为注射部分的一个整体部分。
图3示出的是在使用所述设备时从侧面看到的图1中的实施例。基板10沿患者的皮肤放置并通过例如粘性垫紧固在患者身上。插管9从注射部分下方的基板10的近端侧伸出,并且所述注射部分由壳体3覆盖,所述壳体3由输送部分3、4提供。所述输送部分3、4被紧固到注射部分旁边的基板10的远端侧,并且其同样由壳体3覆盖。
通常通过粘性部分或粘性层将基板10的近端侧固定到患者身上,但也可以使用任何种类的可以将基板10粘住患者而不允许设备移动的安装。所述粘性部分或粘性层可通过胶水、维可牢尼龙搭扣、模制等固定在基板10上。
在优选的实施例中,所述输送部分通过一个或多个嵌入到基板10中的磁铁被紧固到基板10的远端侧。所述可拆卸的输送部分具有相应的磁体,该磁铁可以使输送部分在使用中保持原位。借助于基板10和/或输送部分3、4上的磁铁,可以检测系统条件,如输送部分是否被正确地紧固,流过所述设备的流量是否可以接受,输送部分被紧固到基板上有多久,经过所述设备的体积大小等。
图4示出了处于分离状态的第一实施例,其中可以看到紧固注射部分1的基板10,用于将输送部分紧固到基板10的物体11,以及基板10的柔性部12。为了将输送部分紧固到基部10上,所述输送部分3、4从上方向着基部10被向下推动。柔性部12由两个较细的连接件构成,所述较细连接将被形成为直线并且其通过从基板部分10上去除材料的方式制成。即使紧固在基部10的相反端的输送部分被触摸或推动或仅由于用户的运动而移动,所述基部10的构造连同柔性管5仍允许皮下注射插管9保持在静止位置上。
图5示出了图4中第一实施例的部分放大视图。图5更详细地示出了插管9如何通过插管部分1的主体保持在原位上;所述注射部分通过柔性管5连接到所述连接器2上。被紧固到基部10上与输送部分在基部10的同一侧的连接器2在图中以透明的方式示出,从而可以看到所述连接器针6。所述连接器2优选地由PP、ABS或类似材料制成。
在图1-5中描述的第一实施例中,输送部分3与注射部分1之间的柔性区域由柔性管5构成。所述柔性管可被制造成一件挤压管材,并且其可以由PUR(聚氨酯)、PP(聚丙烯)、PE(聚乙烯)、硅树脂或任何其它具有足够的柔性或例如通过提供带有褶皱的管而具有柔性形式材料制成。
可通过插入器的帮助或者手动地将插管9与注射部分的其余部分一起插入到皮下。
输送部分3、4的壳体3由相对较硬的材料制成,如PP或ABS(聚(丙烯腈,丁二烯,苯乙烯)),这样可以使壳体能够抵抗外界冲击。
图6A示出了从面向注射部分侧看过去的、根据本发明的用于输送流体的设备的第二实施例。图6B示出了相同实施例从直线B-B截取的视图。图7示出了实施例中通过连接器2连接注射部分与输送部分3、4的区域的放大视图。在图6A、6B和7中,所述输送部分和注射部分均连接到基部10,而该状态即在使用中所述设备的状态。
在第二实施例中,所述注射部分1通过柔性管5连接到输送部分3、4上,所述柔性管5在这个实施例中形成为波纹管并优选地由硅树脂、PUR、PP/PE等制成。所述基部10的柔性部12形成为相对薄的V型连接,该连接通过从基部10的平面上去除材料制成。该实施例设有滑轨11,其用作将输送部分3、4紧固到基部10的物体。在这个实施例中,所述连接器针6被紧固到输送部分3、4上。当输送部分与连接器2接合在一起时,所述连接器针6穿透隔膜7,从而形成从储器4至插管9的流动通路。
图8A和8B示出了处于输送部分3、4与基部10相分离的状态下的实施例,这样可以看到两个滑轨11。
图8B示出了图8A中的连接器2的放大视图。在这个实施例中,所述连接器2包括由非柔性材料制成的具有贯穿开口的模制部分,其中该贯穿开口的一端与柔性管5相连,另一端设置有隔膜7。所述柔性管5的柔性可通过使用软的柔性材料获得,但在这个实施例中,所述管5的柔性是通过采用一种稳定的-即具有一定刚度的-并且具有褶皱的材料来构成柔性管5而获得的。储器4设置有连接器针6和圆筒形延伸部,所述延伸部可以保护连接器针6并且可以设置有保护密封件(图8B中未示出)。在连接器2未连接到储器4的状态下,连接器针6延伸至一个封闭室中,所述封闭室包括由储器4的圆筒形延伸部所形成的壁以及一个可选的未示出的弹性保护密封件。在连接状态中,所述保护密封件(如果有的话)朝向围绕连接器针6的储器4的内壁被推动,并且当将连接器2连接到储器4上时,所述连接器针6首先穿透保护密封件,随后穿透所述隔膜,以形成一个从储器4到连接器2内部的通路。在这个实施例中,连接器2被不可释放地紧固到基板10上,其中所述基板10是所述输送部分3、4的一体部分。
图9,10A和10B同样示出了根据本发明第二实施例的设备。图9示出了输送部分3、基部1和注射部分,以及在它们接合之前是如何相对于彼此定位的,以及指示出当输送设备3、4被紧固到基部10的物体11上以形成与注射部分1的连接时的运动方向的箭头。图10A从不同角度示出了与图8A相同的实施例,且图10B示出了图10A中的实施例以圆圈标出的连接器2的放大视图。在这个实施例中,插管9在从注射设备横向伸出并垂直插入用户的皮肤。如果插管9由软的柔性材料制成,则需要使用插入针以穿透用户的皮肤。这可以手动地通过提供一种具有穿过插管9的近端开口伸出的插入针来完成。所述尖锐的插入针从插管9的近端开口伸出,并且其例如穿透覆盖在插管9上的隔膜进入到插管的远端,或者通过侧面进入到所述插管中。在插入针通过侧面进入插管9的情况下,需要提供具有某种封闭的进入位置,从而在当插入针在插入完成后被移除时可以防止微生物进入到所述设备中。这个实施例的所述设备可以利用插入器被插入,例如利用从2005年12月9日申请的PCT申请No.DK2005/050010公开的插入器。如果插管从注射部分的近端侧伸出,则可以利用例如2002年9月27日申请的PCT申请DK02/00640中公开的插入器。
图11示出的实施例中,输送部分3、4位于注射部分的顶部。在这个实施例中,输送部分可释放地紧固到包围插管部分1的基部10的一部分上。围绕注射部分设置的所述基板10的柔性部12形成为环形折叠材料,该材料为更薄的形式的与注射部分的中心部分相同的材料,或者是具有更软或更柔性的特性的不同材料。在图11中,所述输送部分3、4与注射部分接合在一起,象使用所述设备时那样,并且形成了允许流体从储器流动至插管9的连接。左视图与右视图分别示出了沿直线D-D和E-E以垂直角度截取的两个不同的视图。在这个实施例中,用于将输送部分3、4紧固到注射部分上的物体11被形成为从基部10竖立的环形轮廓,并且具有向外突出部,物体11与输送部分上的对应的突出部13相配合。当将输送部分3、4紧固到插管部分1上时,两个把手部14被一起推动,这使得对应的突出部向外移动并允许注射部分进入到输送部分3、4的中心开口中。当用户松开把手部14时,所述对应部分回到更中间的位置并将插管部分1锁定在输送部分3、4的中心开口处。
输送部分3、4与连接器2结合;连接器2具有贯穿的连接器针6,并且该连接器受弹簧15的影响。当用户朝向注射部分推动输送部分3、4时,弹簧15被压缩,并且所述贯穿连接器针6被迫使穿过隔膜8,所述隔膜8用于保护储器中的内容物不被微生物感染。在连接针6被迫使穿透隔膜8的同时或在此之前或在此之后,连接器针6也将被迫使穿过用于保护插管9的入口的隔膜7,从而在未示出的储器与插管9之间形成流体连接。通过为弹簧15选择便利的材料、隔膜8与其它与连接器2相接触的材料,应当保证在连接器2与输送部分3、4之间存在柔性连接。优选地当连接器2从一个位置到另一位置的运动由输送部分3、4的中心延伸部的壁导向时,所述连接器2被紧固到弹簧15上,并且所述隔膜8由一种充分柔软的材料制成,以保证当设备处于连接状态时,连接器2柔性地连接到输送部分3、4上。在这个实施例中,连接器2并不必需被紧固到输送部分3、4上或是注射部分1上,连接器2可以是用作独立接口的独立单元或与输送部分3、4或注射部分成一体。
图12示出的是图11中的实施例,该实施例处于注射部分与输送部分3、4分离的状态下,并且使弹簧5处于松弛和延伸状态。在这种状态下,所述贯穿连接器针6既没有穿透输送部分3、4的隔膜8,也没有穿透插管部分1的隔膜7。
图13示出了图11和12中的实施例的三维形式。该视图从侧面示出输送部分3、4和接合到输送部分上的注射部分1,其中当接合时,这两个部分彼此对应。
图11-13中的示出的实施例可以通过2002年9月27日申请的PCT申请DK02/00640中公开的插入器类型被插入。在注射部分被插入后,用户将基部10固定到皮肤上。注射部分处于合适后,用户可以随后将输送部分紧固到注射部分1上,其中所述输送部分包括至少一个储器和传送装置例如泵。如果连接器2为独立接口的形式,则连接器应当在输送装置3、4被紧固在注射部分之前被放置,并且所述连接器随后将在选择的注射部分和选择的输送部分3、4之间提供适当的配合。
当引入图1-13中描述的和权利要求中所要求的柔性区域时,由于可以在不影响插管9和不扰乱插入部位的情况下向侧面拉、推、提和移动输送部分3、4,因此可以在由被使用部分的尺寸所定义的确定边界内的所有维度上移动所述可释放输送部分3、4,通常扰乱插入部分的部位会引起患者不适。
实施例的所有部件被固定到患者的皮肤上,并且这通常通过应用一个安装垫来实现,其中该安装垫附着在基部10的近端侧,或者如果实施例不提供基部10,则安装垫附着在输注部分的近端侧。将安装垫附着到基部10或输注部分1上的手段可包括利用胶粘、维可牢尼龙搭扣、模制等。
图14示出了本发明的一个实施例,在该实施例中可以保证流体能够流体密封地从输送部分3、4的储器传送至插管部分1的插管9并由此传送给患者。
在图14中,“A”示出了从侧面看过去的三维形式的所述设备,其中该设备同时包括输送部分3、4和包括插管部分1的注射部分,“B”示出了从下方看过去的三维形式的输送部分3、4,并且“C”示出了从上方看过去的三维形式的注射部分1。
图15示出了与图14相同的实施例,并且其为从直线V-V截取的侧视图。在图15中,所述输送部分3、4与注射部分是分离的,并且连接器针6由向下的隔膜8b保护,所述隔膜8b用于防止细菌从连接器针6的端部进入到储器中。隔膜8a用于防止储器的入口被连接器针6的另一端穿透。在图15中,示出的储器4位于连接器针6的上方,并且示出了储器4上方的储器盖4a。当例如需要更换构成储器4的安瓿时,可以移除所述储器盖4a。在这个实施例中,储器4具有柔性壁,并且其由环16包围,所述环16可以减小储器的体积,并且因此可以将流体从储器4泵送至患者。在这个实施例中,插管部分1也具有入口隔膜7和用于将输送部分3、4紧固到注射部分上的物体11,所述物体11被形成为从基板10竖立的环形轮廓,并且其与注射部分1的壳体的外表面相结合。所述物体11的向外突出部与输送部分3、4上的对应突出部13安装。当输送部分3、4被紧固到注射部分上时,一起推动两个把手部分14以迫使对应突出部13向外,并允许注射部分进入输送部分3、4中的中心开口。当用户释放把手部分14时,对应部分13回到更中心的位置并将注射部分锁定到输送部分3、4的中心开口处。在这个实施例中,插管部分1可由非刚性材料制成,以提供一个柔性部分,其增加的柔性保证了输送部分3、4的运动不会被传送至插管9。
图16示出了与图14,15相同的实施例,但是在图16中,输送部分3、4和注射部分如在使用中一样接合在一起。在这个位置中,连接器针6穿透所有的三个隔膜8a,8b和7,并在储器4与注射部分之间构成流体连接。
图17示出了实施例的分解视图,其中所述设备包括输送部分3、4的储器与注射部分之间的第二流体密封连接。这个实施例包括包含泵和储器的输送部分、第一弹簧15、上部密封垫17、下部密封垫18、第二弹簧19和注射部分,该注射部分包括包含插管9的插管部分1、插入针20、外壁26和安装垫21。此外所述输送部分的外表面、盖或壳体2具有凹槽24,并且注射部分的所述外壁26的外表面具有对应的榫舌25。
在图18中示出了图17所示的实施例中的单独的部分是如何一起工作的。在这个图中示出了注射部分与输送部分3、4的内部。在图18中示出了储器4在输送部分3中的可能的位置以及从储器4伸出的出口管22。在出口端,即图18中的最低端,出口管22设置有横向指向的开口和密封垫,所述密封垫用于保证插管部分1的中心部分的壁与出口管22的出口之间的流体密封接触。插管部分1的内部包括贯穿的流体通道23,所述流体通道23具有横向穿过注射部分的中心部分的竖直壁的入口开口。为提供插管部分1的柔性部分,所述外壁26可由弹性的或非刚性材料制成。所希望的弹性程度将取决于输送设备的物理特征,即尺寸和重量。
在第一位置中,包括储器4和泵的输送部分可从注射部分缩回,第一弹簧15被伸长,出口管22的出口被注射部分的中心部分的壁、即插管部分1所阻挡。下部密封垫18处于可阻挡流体通道23入口的一个较高位置上,并且第二弹簧19被伸长。
在第二位置中,输送部分3、4被朝向注射部分推动,并且第一弹簧15和第二弹簧19均被压缩。在第一位置时用作阻挡细菌的屏障的下部密封垫18此时被输送部分3、4的下边缘向下推动,并且因此打开了流体通道23的入口。当注射部分的榫舌25接触到输送部分3、4的凹槽24的上侧时,输送部分的向下运动停止,并且在这个位置,出口管22的开口与流体通道23的入口相对应。
图19示出了在储器与注射部分之间的流体密封连接的实施例。在这个实施例中,所述柔性部分可以由弹性“气泡”26和27提供。这种设备包括输送部分3、4,例如在图1-10中所示的,但储器仅在图19中示出。该设备构造有出口由气泡形状的可变形膜26覆盖的储器;该膜可以在输送部分未与注射部分1接合时防止微生物进入储器。气泡形状的膜意味着所述膜不具有平坦的内外表面,而具有凸的内外表面,并且所述膜不仅覆盖连接器针6的针尖,而切还覆盖连接器针6的更大的部分。所述注射部分1的入口也由可变形气泡形状的膜覆盖。在这个实施例中,连接器针6被紧固到注射部分1上,但所述连接器针6也可以被紧固到输送部分3、4上,如果连接器针6被紧固到输送部分上,则需要提供具有两个针的组合设备:连接器针6和插管9。如果所述设备设置有与插管9相分离的连接器针6,则可以使用柔软的插管。
图19A示出了所述设备的三维视图,其中该设备处于输送部分3、4与注射部分1相分离从而使得流体不能在两部分之间流动的状态。图19B示出了与图19A相同的状态,但是该图为通过从竖直角度切割设备所看到的视图,在图19C中,输送部分3、4和注射部分1被推到一起,并且储器4的流体现在能通过注射部分1和插管9流到患者体内。当所述两个膜被推到一起时,薄膜发生变形且非常尖的连接器针6穿透两个膜并形成流体连接,可以将每个气泡形膜形成为具有不同的硬度,从而当变形最少的膜推压变形最大的膜时,通过利用不同硬度使变形最少的膜形成基部,从而可以对期望穿透所述膜的位置进行控制。
膜26和27可由硅树脂或聚氨酯(PUR)制成,或由其它能够被针刺穿但不会被微生物穿透的柔软聚合体制成。
连接器针6由相对硬的材料制成,如金属或硬聚合物,其中“相对硬的材料”意味着所述材料应当至少具有一定强度,即足够硬,以穿透膜26,27。
在图19A,B和C的实施例中,连接器针6的一端为单独的针,其另一端则用作插管9。当连接器针6和插管被形成为一个针时,其通常将由金属或硬聚合物制成,但其还可以由例如连接器端被硬化而插管端未硬化并且是软的。同时所述单独的针可以由两种不同材料组成,在连接器端采用较硬的材料,而在插管端采用相对软的材料。
同时还可以将连接器针6与插管9相分离,并将根据本发明的设备制造成具有两个针。注射部分1可以设置有公知的柔软的插管,该插管可通过附接在分离的插入器上的插入针的辅助下被插入,并且连接器针6由较硬材料制成,并被紧固到注射部分1或输送部分3、4上。
在这个实施例中,单独的针是弯曲的,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。根据本发明的连接器针6可以指向任何平行或远离于患者的方向,而插管9可以指向可以将其插入患者皮肤的任何方向。
根据本发明的设备可以用于与患者可通过持续摄入药物产品而获益的所有药物和所有条件相关的地方;优选地本发明意在为患有糖尿病的患者提供一种可以向患者提供持续调节剂量的胰岛素的安全和易于操作的设备。
在一个实施例中,储器被分为多个分离的腔,其中每个腔可以提供有不同的药物,或者例如在一个腔中提供活性的药物成分,而在其它腔中提供溶剂,不同的腔室可以包含不同浓度的药物或具有不同活性成分的药物。
图20-25示出了本发明的一个实施例,其中连接器2被置于基板10的中间位置处,而插管部分1b被紧固到基板10的外周部分。插管部分1b设置在外周上使得用户可以观察注射部位。此外,本实施例的插管部分以这种方式设置,即插管9以相对于基板10的远端表面偏离90°的角度A被插入,通常角度A在110°至170°之间,其中基板10的远端表面形成所述角度的一边,而插入的插管9形成角度的另一边。
在这个实施例中,通过提供柔性部分12将柔性部分结合在基板10上,其中所述柔性部分由基板10构造并形成如车轮一样的四个辐条。可以通过改变所述部分12的宽度、基板材料10的厚度或所述部分12(辐条)的数量来改变柔性部分12的弹性。
插管部分为两部分单元,其包括不可释放地紧固在基板10上的第一部分1a和包括提供引导液体流向插管9的贯穿开口的主体的第二部分1b,其中插管9在插入后在基板10的近端侧延伸。插管部分1a,1b部分地形成患者与储器之间的流体连接。
可以通过至少两种不同的方法将本实施例置于患者的皮肤上。根据一种方法,包括第一部分1a的基板10首先被置于患者皮肤上,随后插管部分1的保持插管的第二部分1b被插入,例如通过特别适用的插入器,这种方法使得用户在放置通常配备有粘性垫的基板10时更加小心。根据第二个方法,包括第一部分1a和保持插管的第二部分1b的基板10通过适用于保持整个设备的插入器一起被插入,这种方法与之前描述的方法相比,其减少一个安装步骤。
在这个实施例中,第一部分1a设置有向内突出部分1c,而第二部分1b设置有向外突出的、可枢转紧固的钩1d。当第二部分1b位于第一部分1a中时,向外突出的钩1d首先被向内突出部分1c向外推动,并且在通过突出部分1c后,突出钩1d回到原来的位置并将第一部分1a锁定在第二部分1b内。
基板10设置有三个用于将输送部分3、4紧固到基板10上的竖直放置的物体11;所述物体11的数量是可选的,并且物体11可以与基板10模制在一起或在形成基板10后例如通过胶粘或焊接而紧固到基板10上。物体11设置有滑槽11a,其中滑槽11a定义了在将输送部分3、4紧固到基板10上时输送部分3、4运动的方向。滑槽11a对应于输送部分3、4上的突出部分11b。在这个实施例中,滑槽11a不与基板10的表面平行,而是相差一个角度B:0°<B<45°,其中角度B的一个侧边为基板10的远端表面,另一个侧边为滑槽11a的远端边缘。所述角度B连同输送部分3、4的圆形形状和连接器2的中心位置一起使得能够将输送部分3、4旋拧到基板10上。
连接器2由不可释放地紧固到基板10上的模制主体构成,其设置有内部隔间,该内部隔间的入口由隔膜7保护。当输送部分3、4被紧固到基板10上时,隔膜7被连接针6穿透。通过内部隔间与开口5a的下部允许流体进入到柔性管5中并通过插管9被传送到患者身上。柔性管5被连接到注射部分的第一部分1a上,并且当插管9的第二部分1b被置于第一部分1a中时,形成了从柔性管5至插管9的流体通道。
示出的实施例的储器4通常保存0.5-3ml的传送至患者的流体。
图26-29示出了本发明的一个实施例,其中连接器针6被直接插入到注射部分中,即没有分离的连接部分。插管部分1被置于基板10的中心位置处,并且因此用户可以观察到注射部位。
在这个实施例中,柔性部分12由基板10构成,并形成为如车轮中的四个辐条。
插管部分1为一个单元,其包括具有内部隔间的模制主体。当包含储器4的输送部分被放置在正确位置时,可由连接器针6穿过保护密封件7进入到所述内部隔间内。来自内部隔间的流体可通过插管9被导出。
基板10与图20-25中的实施例相似,其中该实施例设置有三个用于紧固将输送部分3、4紧固到基板10上的竖直放置的物体11;所述物体11的数量是可选的。
在图26-29的实施例中,基板10被放置在患者皮肤上的同时注射部分的插管9被插入,并且所述插管9以90°角被插入。为插入所述设备,可以使用如EP 1429826中所示类型的插入器。
图30-32示出的本发明的实施例与图26-29所示的实施例相似,只是该实施例不具有分离的连接器。插管部分1a,1b被置于基板10的中心位置上,因此其可以使用户观察到注射部位。
在这个实施例中,柔性部分12同样由基板10构成并形成如车轮的四个辐条。
两部分单元的插管部分包括不可释放地紧固到基板10上的第一部分1a和包含插管9的第二部分1b。根据本发明,基板10被首先置于患者的皮肤上,随后插管部分的插管保持部分1b被插入指定位置。类似图20-25示出的实施例,这个实施例的第一部分1a设置有向内突出部分1c,第二部分1b设置有向外突出的并可枢转地紧固的钩1d,所述钩1d的对应部分可以将第二部分1b锁定在理想位置上。
图33-36示出了本发明的一个实施例,其中插管部分1被紧固到基板10的外周部分,从该外周部分的位置上可以执行倾斜的注射,并且可以使用户观察到注射部位。在这个实施例中,插管部分为两部分类型,其包括被不可释放地紧固到基板10上的第一部分1a和包含插管9的第二部分1b。所述第一部分1a设置有向内突出部分1c,第二部分1b设置有向外突出的并可枢转紧固的钩1d。
这个实施例的柔性部分12同样根据基板10构造,但此处所述柔性部分12形成为类似格栅的形式。根据这个实施例,通过改变所述柔性部分12的宽度、基板材料10的厚度或所述柔性部分即连杆12的数量,可以改变柔性部12的柔性。
基板10设置有两个用于将输送部分3、4紧固到基板10上的竖直放置的物体11;所述物体11的数量是可选的,并且物体11可以与基板10一起模制,或者在形成基板10后通过例如胶粘或焊接而紧固到基板10上。物体11设置有滑槽11a,其中滑槽11a定义了在将输送部分3、4紧固到基板10上时所述输送部分3、4移动的方向。在这个实施例中,每个物体11均设置有滑槽11a,该滑槽11a定义了在将输送部分3、4紧固到基板10上时输送部分3、4的运动方向。在这个实施例中,每个物体11均具有两个滑槽11a,并且每个滑槽11a都倾斜一个角度B:0°<B<90°。所述滑槽11a对应于输送部分3、4的突出部分11b。由于输送部分3在被紧固到基板10上的过程中沿明确限定的通道移动,因此基板10的滑槽11a与输送部分3的突出部分11b之间的相互作用保证了连接器针6能够穿过注射部分1b的保护密封件7而被正确的插入。
通常当插管部分1由一个两部分单元1a,1b构成时,将所述设备固定到患者的皮肤上的方法可包括以下步骤:
-如果基板10设置有粘性表面,例如不可释放地结合有粘性垫,则基板10的粘性侧可以例如通过去除释放衬垫而暴露出来,
-将包括注射部分1a的一部分的基板10置于患者的皮肤上,
-通常通过使用插入设备将注射部分1b的第二部分插入由第一部分1a所定义的位置中,其中该插入设备可以是多用途插入设备或单用途插入设备,
-将输送部分3置于基板10的顶部。
图37-39示出本发明的一个实施例,其中插管部分1位于注射部分的基板10的中心位置。所述基板10在这个实施例中被构造为三个柔性部分12,该柔性部分12可以例如与插管部分1一起模制或不可释放地被附接到安装垫21上,其中所述垫也可以为插入部分提供一定程度的稳定性。所述柔性部分12是相对平坦的,即其高度小于其宽度,并且其由一种可以为注射部分提供具有理想柔性的结构的材料制成。
可以通过改变所述柔性部分12的数量以及所述柔性部分12的宽度和厚度来改变所述柔性部分12的弹性。
插管部分1包括主体,该主体具有引导液体至未示出的插管9的贯穿开口,其中插管9在被插入后在注射部分的近端侧伸出,即插管部分1在患者与储器4之间部分地形成流体连接。插管1还设置有环形竖直壁11,在这个实施例中,该环形竖直壁11构成输送设备3的紧固装置。
这个实施例的输送部分与注射部分通过将两个部分按压在一起而接合。
图40示出了另一个实施例,其中注射部分没有设置安装垫,输送部分同时通过在中心插管部分上向下旋转所述输送部分并通过将它卡合到外周的竖直物体11上而被紧固到注射部分上。该外周物体11将输送部分固定到靠近用户皮肤的位置。
在这个实施例中,柔性部分12由基板10构造,并形成如车轮的三个辐条。
所述插管部分1为一个单元,其包括具有内部隔间的模制主体。可以通过例如当包含壳体3和储器4的输送部分位于正确位置时由连接器针穿透保护密封件进入所述内部隔间。
基板10与图20-25的实施例相似,其具有三个用于将输送部分3、4紧固到基板10上的竖直放置的物体11;此外,插管部分1的外壁设置有滑槽11a,该滑槽11a定义在将输送部分3、4紧固到基板10上时所述输送部分3、4的运动方向。所述滑槽11a与输送部分3、4的突出部分相对应。当输送部分到达到基板10时,竖直的外周部分11向外枢转,且随着竖直外周部分11枢转回竖直位置,所述输送部分到达其末端位置同时具有卡合声。由输送部分与外周部分11之间的共同协作而提供的卡锁同时将所述设备保持在靠近用户皮肤的位置上。
图41a-b示出了输送部分的壳体3的不同实施例。
Claims (33)
1.用于输送流体的设备,包括注射部分和流体输送部分(3、4),其中所述流体输送部分包括储器(4)、例如泵形式的传送装置以及壳体(3),并且所述注射部分包括:
-基板(10),
-插管部分(1,1b),包括具有将流体引导至插管(9)的贯穿开口的主体,其中插管(9)延伸超过基板(10)的近端侧,和
-将所述基板固定到用户的皮肤上的装置(21),
其特征在于,在插管(9)的置于皮下的部分与流体输送部分(3、4)之间的区域内设置有柔性部分。
2.根据权利要求1所述的设备,其特征在于,所述柔性部分被集成在所述基板(10)中。
3.根据权利要求2所述的设备,其特征在于,所述基板(10)部分地或全部地由柔性材料构成。
4.根据权利要求1所述的设备,其特征在于,所述柔性部分被集成在所述插管部分(1)的所述具有将流体引导至插管(9)的贯穿开口的主体中。
5.根据权利要求4所述的设备,其特征在于,所述插管部分(1)的主体部分地或全部地由柔性材料构成。
6.根据权利要求1所述的设备,其特征在于,所述柔性部分被集成在所述流体输送部分(3、4)中。
7.根据权利要求1所述的设备,其特征在于,所述柔性部分为设置在所述流体输送部分(3、4)和所述注射部分之间的独立单元。
8.根据权利要求7所述的设备,其特征在于,所述独立单元部分地或全部地由柔性材料构成。
9.根据权利要求1所述的设备,其特征在于,所述流体输送部分(3、4)和所述注射部分可以被分离和重新接合。
10.根据权利要求1所述的设备,其特征在于,所述基板(10)具有紧固装置(11),其用于连接和断开从所述基板(10)的远端侧延伸的所述输送装置(3、4)。
11.根据权利要求1所述的设备,其特征在于,所述流体输送部分(3、4)的壳体(3)还提供了所述注射部分的壳体。
12.根据权利要求1所述的设备,其特征在于,柔性部分(5,12)由具有减小材料尺寸的区域构成。
13.根据权利要求1所述的设备,其特征在于,柔性部分(5,12)由用更软的并且更具柔性的材料制成的区域构成。
14.根据权利要求1所述的设备,其特征在于,柔性部分(5,12)由通过其形状而具有延展和压缩能力的材料制成的区域构成,所述材料例如被打褶或折叠或波纹状的材料。
15.根据前述任一权利要求所述的设备,其特征在于,所述插管(9)和所述输送部分(3、4)不是通过非柔性区域互连的。
16.根据权利要求1-15所述的设备,其特征在于,当所述输送部分(3、4)和所述注射部分接合在一起时,形成将流体从所述储器引导至所述插管(9)的流体密封连接。
17.根据权利要求16所述的设备,其特征在于,由于当所述流体输送部分(3、4)与所述注射部分分离时,通向储器(4)的开口被阻挡,因此在所述两个部分分离的期间内,防止微生物进入所述流体输送部分的储器(4)。
18.根据权利要求17所述的设备,其特征在于,所述储器(4)具有两个位置,即第一位置和第二位置,当处于第一位置时,储器(4)的出口被微生物不可穿过的第一屏障(8,8a,26)阻挡,插管部分(1,1b)中的贯穿开口的入口被微生物不可穿过的第二屏障(7,18,27)阻挡,当处于第二位置时,通过穿过所述第一和第二屏障而在所述储器(4)和所述插管部分(1,1b)的贯穿开口之间形成打开的流体连接。
19.根据权利要求18所述的设备,其特征在于,所述屏障(8,8a,26,7,8b,27)中的一个或两个包括可被针状物体穿透的材料,其中当所述针状物体缩回时,所述开口关闭。
20.根据权利要求19所述的设备,其特征在于,所述针状物体为钝的。
21.根据权利要求19所述的设备,其特征在于,所述针状物体为尖头的。
22.根据权利要求18所述的设备,其特征在于,所述屏障(18)中的一个或两个包括坚硬的表面,该表面被移动,以便在设置于出口管(22)的出口与贯穿流体通路(23)的入口之间的区域中形成开口。
23.根据权利要求1-22所述的设备,其特征在于,用于将所述基板(10)固定到用户的皮肤上的装置包括安装垫,该安装垫粘附在所述基板(10)的近端侧和/或所述插管部分(1,1b)的近端侧。
24.根据权利要求2或12所述的设备,其特征在于,所述基板(10)为格栅的形式,具有连贯的外周部分以及一个或多个与所述外周部分互连的连杆(12)。
25.根据权利要求24所述的设备,其特征在于,所述基板(10)具有圆形或椭圆形的外周部分,并且所述连杆(12)具有连接到所述外周区域的一端和连接到中心区域的第二端。
26.根据权利要求24-25所述的设备,其特征在于,所述基板(10)具有三个或更多个连杆(12)。
27.根据权利要求1-26所述的设备,其特征在于,所述基板(10)在使用之前不设有插管(9)。
28.根据权利要求27所述的设备,其特征在于,所述基板(10)的一部分具有开口,插管(9)可经由该开口插入。
29.根据权利要求28所述的设备,其特征在于,所述插管(9)的一端具有一主体,该主体包括实心壁和用于保护所述插管(9)入口的保护密封件(7,7a)。
30.根据权利要求27-28所述的设备,其特征在于,所述基板(10)装备有插管部分的第一部分(1a),该第一部分用作第二部分(1b)的定位控制器,其中第二部分(1b)包括插管(9)并且要被插有注射针。
31.根据权利要求30所述的设备,其特征在于,所述插管部分的第一部分(1a)装备有用于将所述第二部分(1b)锁定在所需位置的装置。
32.根据权利要求28-31所述的设备,其特征在于,所述插管(9)插有一插入设备,该插入设备具有与所述基板(10)的表面对应的装置,并且当所述插入设备的所述装置与所述基板的相应表面结合时,所述插入设备以这样的方式定位,即,包括向插管提供流体通路的主体的插管(9)可相对于所述基板(10)被可预知地并且正确地插入。
33.根据权利要求1所述的设备,其特征在于,所述基板(10)与一安装垫不可释放地连接。
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