CN101489608B - Medical delivery system with asymmetrical coding means - Google Patents
Medical delivery system with asymmetrical coding means Download PDFInfo
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- CN101489608B CN101489608B CN2007800267716A CN200780026771A CN101489608B CN 101489608 B CN101489608 B CN 101489608B CN 2007800267716 A CN2007800267716 A CN 2007800267716A CN 200780026771 A CN200780026771 A CN 200780026771A CN 101489608 B CN101489608 B CN 101489608B
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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
- A61M5/178—Syringes
- A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
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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
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/3129—Syringe barrels
- A61M5/3135—Syringe barrels characterised by constructional features of the proximal end
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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
- A61M5/178—Syringes
- A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
- A61M2005/2403—Ampoule inserted into the ampoule holder
- A61M2005/2407—Ampoule inserted into the ampoule holder from the rear
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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
- A61M5/178—Syringes
- A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
- A61M2005/2485—Ampoule holder connected to rest of syringe
- A61M2005/2488—Ampoule holder connected to rest of syringe via rotation, e.g. threads or bayonet
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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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/60—General characteristics of the apparatus with identification means
- A61M2205/6045—General characteristics of the apparatus with identification means having complementary physical shapes for indexing or registration purposes
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Abstract
Description
技术领域 technical field
本发明涉及一种包括用于容纳药剂的容器和适于紧固到该容器的定量组件的医疗输送系统。具体地,本发明涉及定量组件的第一紧固装置和/或容器的第二紧固装置,所述第一紧固装置和所述第二紧固装置在垂直于设备的轴向方向的平面中限定非对称图案。此外,本发明涉及一种容器和定量组件,该容器和定量组件的每一个适合用于根据本发明的医疗输送系统中。The invention relates to a medical delivery system comprising a container for containing a medicament and a dosing assembly adapted to be secured to the container. In particular, the invention relates to first fastening means of the dosing assembly and/or second fastening means of the container, said first fastening means and said second fastening means being in a plane perpendicular to the axial direction of the device An asymmetric pattern is defined in . Furthermore, the invention relates to a container and a dosing assembly, each of which is suitable for use in a medical delivery system according to the invention.
背景技术 Background technique
一般地,为了提供很可能被特殊患者群完全接受的优良的给药装置,已针对患者的利益而推出了更加多样性的给药系统。随着可商业购得的输送系统的数量的增加,散布了许多不同类型的药物保持筒或容器。这些类型的容器的大部分在许多方面不同。In general, a greater variety of drug delivery systems has been introduced in the interest of patients in order to provide a superior drug delivery device that is likely to be well accepted by a particular patient group. As the number of commercially available delivery systems has increased, many different types of drug retention cartridges or containers have spread. Most of these types of containers differ in a number of ways.
每个药剂容器可充满从很多种不同药剂中选择的特定药剂类型,而且不同种类的同类药剂(例如快速或长效胰岛素)以及不同浓度的每种特定药剂可容纳在容器中。Each medicament container can be filled with a particular medicament type selected from a number of different medicaments, and different classes of the same medicament (eg rapid or long-acting insulin) as well as different concentrations of each particular medicament can be contained in the container.
此外,可引入不同的容器容积以便针对特定用户的需求来定制每个容器从而定制输送系统。容器容积的变化可通过改变容器的长度或直径来实现。这些更改通常意味着给药系统的定量组件的相应更改,由此以提供用于从容器中喷出药剂的特定冲程的驱动元件或者提供最佳的定量精度。此外不同药剂容器之间的区别可能由每个特定输送系统的设计需求,诸如容纳在容器中的活塞的所需滑动摩擦造成。In addition, different container volumes can be introduced to tailor each container and thus the delivery system to the needs of a particular user. Variations in container volume can be achieved by changing the length or diameter of the container. These modifications generally mean corresponding modifications of the dosing components of the dosing system in order to provide a specific stroke of the drive element for ejecting the medicament from the container or to provide an optimum dosing accuracy. Furthermore differences between different medicament containers may result from the design requirements of each particular delivery system, such as the required sliding friction of the piston contained in the container.
为了在更多种类的可利用容器之间进行区别,已经开发了许多主要依靠特定容器的电子阅读和识别的容器编码系统,以便允许通过专门的输送装置来输送特定类型的药剂。在现有技术中,下列机械编码系统是公知的:In order to differentiate between the wider variety of containers available, a number of container coding systems have been developed that rely primarily on electronic reading and identification of specific containers in order to allow specific types of medicament to be delivered by specialized delivery devices. In the prior art, the following mechanical coding systems are known:
US 5611783涉及一种包括远端部和近端部的笔形注射器,该远端部可包括安瓿,而该近端部含有剂量设定和驱动机构。近端和远端部具有联锁式卡口联接装置。可设置突出体以形成确保特定的远端部仅可与特定的近端部结合使用的图案。US 5611783 relates to a pen-shaped injector comprising a distal part, which may contain an ampoule, and a proximal part, which contains a dose setting and drive mechanism. The proximal and distal sections have interlocking bayonet couplings. The protrusions may be arranged to form a pattern that ensures that a particular distal portion can only be used in conjunction with a particular proximal portion.
WO 03/017915 A1公开了一种具有远端的筒,该远端设有机械编码。该机械编码具有圆形突出体的形式,其中圆形外径专门用于容纳在筒中的特定浓度的胰岛素。WO 03/017915 A1 discloses a cartridge having a distal end provided with a mechanical coding. This mechanical coding is in the form of a circular protrusion with a circular outer diameter dedicated to a particular concentration of insulin contained in the cartridge.
US 5693027公开了一种用于使标准筒适合于所选注射器的塑料盖。该塑料盖可设有用于与注射器中的相应装置键入接合的装置,以当筒安装在注射器中时,保持塑料盖不可旋转。在一些类型的注射器中,筒与注射器之间的这种键入接合还用于确保仅使用特定类型的筒。US 5693027 discloses a plastic cap for adapting a standard barrel to a selected syringe. The plastic cap may be provided with means for keyed engagement with corresponding means in the syringe to hold the plastic cap against rotation when the barrel is mounted in the syringe. In some types of syringes, this keyed engagement between the barrel and the syringe also serves to ensure that only certain types of barrels are used.
US 6648859 B2公开了一种药筒组件,用于与给药笔的可再利用笔体组件一起使用。为了避免交叉使用,将笔体组件和药筒锁上,即它们可通过相应的螺纹和凹槽、卡口螺纹和凹槽、搭配或一对以反Luer-Lock方式配合的接线片来螺纹接合。选择匹配构件以防止与其它组件的交叉使用,例如螺纹的螺距可形成角度以便仅彼此相配而不与其它组件相配。US 6648859 B2 discloses a cartridge assembly for use with a reusable pen body assembly of a drug delivery pen. To avoid cross-use, the pen body assembly and cartridge are locked, i.e. they can be threadedly engaged by corresponding threads and grooves, bayonet threads and grooves, mating or a pair of lugs that mate in a reverse Luer-Lock fashion . Mating components are chosen to prevent cross-use with other components, eg the pitch of the threads may be angled so as to only mate with each other and not with other components.
另一现有技术的系统在DE 20110690中公开。Another prior art system is disclosed in DE 20110690.
本发明的优选实施例的目的是为公知的系统提供一种备选方案。而且,本发明的优选实施例的目的是提供具有大量可能的编码几何图形的给药系统。The purpose of the preferred embodiments of the present invention is to provide an alternative to known systems. Furthermore, it is an object of preferred embodiments of the present invention to provide drug delivery systems with a large number of possible encoding geometries.
此外,本发明的优选实施例的目的是提供一种编码系统,其中当将预定医疗输送系统的容器和定量组件彼此联接/分开时,使用者经历基本相同的操作紧固运动,与在兼容的容器和定量组件的组中的特定选择无关。另外,本发明的优选实施例的目的是提供这样一种系统,该系统具有大量的不同编码容器/定量组件同时获得将机械故障的可能性减到最小的耐用系统。Furthermore, it is an object of preferred embodiments of the present invention to provide a coding system in which the user experiences substantially the same operative fastening motion when coupling/detaching the container and dosing assembly of a predetermined medical delivery system from each other, as in compatible The specific selection in the group of containers and quantitative components is irrelevant. Furthermore, it is an object of the preferred embodiments of the present invention to provide such a system with a large number of different coded container/dosing assemblies while obtaining a durable system which minimizes the possibility of mechanical failure.
此外,本发明的优选实施例的目的是提供一种用于将容器紧固到定量组件的直观紧固机构。Furthermore, it is an object of preferred embodiments of the present invention to provide an intuitive fastening mechanism for fastening a container to a dosing assembly.
发明内容 Contents of the invention
在第一方面中,本发明涉及一种医疗输送系统,包括:In a first aspect, the invention relates to a medical delivery system comprising:
容器,其适于在由容器和可滑动设置的活塞限定的腔室中容纳药剂,该活塞可沿远端方向朝着出口移动以便减小腔室的容积并通过出口喷出药剂;a container adapted to contain a medicament in a chamber defined by the container and a slidably disposed piston movable in a distal direction towards the outlet to reduce the volume of the chamber and eject the medicament through the outlet;
定量组件,其适于紧固到容器,以便允许定量组件的驱动器沿远端方向移动容器的活塞;a dosing assembly adapted to be fastened to the container so as to allow the driver of the dosing assembly to move the piston of the container in a distal direction;
其中定量组件限定了第一紧固装置,在容器与定量组件的紧固期间,该第一紧固装置与容器的第二紧固装置接合,由此容器通过由第一和第二紧固装置中的至少一个限定的预定运动而紧固到定量组件,该预定运动小于一个回转;Wherein the dosing assembly defines first fastening means, which engages with second fastening means of the container during fastening of the container to the dosing assembly, whereby the container is passed by the first and second fastening means Fastened to the dosing assembly for at least one defined predetermined movement of less than one revolution;
其中第一和第二紧固装置中的一个的侧壁限定至少两个沿径向方向延伸的突出部,所述至少两个突出部的每一个适于与限定在第一和第二紧固装置中的另一个的侧壁中的相应凹槽接合;以及Wherein the side wall of one of the first and second fastening means defines at least two protrusions extending in a radial direction, each of said at least two protrusions being adapted to be defined in the first and second fastening means engages with a corresponding groove in the sidewall of the other of the devices; and
其中第一和第二紧固装置中的至少一个在垂直于设备的轴向方向的平面中限定非对称图案。Wherein at least one of the first and second fastening means defines an asymmetric pattern in a plane perpendicular to the axial direction of the device.
因为仅预定容器可附接到定量组件,所以根据本发明的医疗系统提高了使用者的安全性。因此,该定量组件可指定与预定种类和/或浓度的药剂一起使用,由此容纳其它浓度或类型的药剂的容器不能附接到该定量组件。The medical system according to the invention increases user safety since only predetermined containers can be attached to the dosing assembly. Thus, the dosing assembly may be designated for use with a predetermined type and/or concentration of medicament, whereby containers containing other concentrations or types of medicament cannot be attached to the dosing assembly.
在本发明的上下文中,术语“医疗输送系统”应被理解为任何能够施用含有药剂的可流动药品的系统。医疗输送系统的示例是输液泵应用、定量给料器、笔形定量给料器、马达定量给料器和诸如自动笔(TM)的自动化注射器。In the context of the present invention, the term "medical delivery system" is to be understood as any system capable of administering a flowable pharmaceutical containing a medicament. Examples of medical delivery systems are infusion pump applications, dosers, pen dosers, motor dosers, and automated injectors such as the Automatic Pen(TM).
本发明可应用于各种能够将药剂从适于联接到输送设备的定量组件的容器输送到使用者的给药设备。该输送设备可包括任何用于药品的经皮、皮下、静脉内、肌肉内或肺部施用的输送设备。The invention is applicable to a variety of drug delivery devices capable of delivering a medicament to a user from a container adapted to be coupled to a dosing assembly of the delivery device. The delivery device may include any delivery device for transdermal, subcutaneous, intravenous, intramuscular or pulmonary administration of a drug.
如此处所用的,术语“药剂”意味着包括任何能够以可控方式通过诸如空心针的输送装置的含有药剂的可流动药品,诸如液体、溶液、凝胶或微悬浮液。典型的药剂包括诸如缩氨酸、蛋白质(例如,胰岛素、胰岛素类似物和C-缩氨酸)和激素的医药品、生物学获得的制剂或活性剂、基于激素和基因的制剂、营养配方以及其它固体(配送)或液体形式的物质。As used herein, the term "medicament" is meant to include any flowable pharmaceutical product containing a medicament, such as a liquid, solution, gel or microsuspension, capable of being passed in a controlled manner through a delivery device such as a hollow needle. Typical agents include pharmaceuticals such as peptides, proteins (e.g., insulin, insulin analogs, and C-peptides) and hormones, biologically derived agents or agents, hormone and gene-based agents, nutritional formulations, and Other substances in solid (delivery) or liquid form.
容器的腔室可由容器的一个或多个侧壁以及可滑动设置的活塞限定。在大多数实施例中,容器的至少一部分是环形的并限定接收活塞的圆柱形腔。容器的远端可包括用于被套管穿透的密封件,以便允许容纳在腔室中的药剂通过该套管喷出。容器的远端可适于附接到保持套管的固定器。作为示例,容器的远端可包括螺纹,该螺纹适于与固定器的相应螺纹配合,以便能将固定器旋拧到容器上。The chamber of the container may be defined by one or more side walls of the container and a slidably disposed piston. In most embodiments, at least a portion of the container is annular and defines a cylindrical cavity that receives the piston. The distal end of the container may comprise a seal for being pierced by the cannula to allow the medicament contained in the chamber to be ejected through the cannula. The distal end of the container may be adapted for attachment to a holder holding the sleeve. As an example, the distal end of the container may include threads adapted to mate with corresponding threads of the holder so that the holder can be screwed onto the container.
容器的出口可适于与套管或针或针头接口或输液装置或任何其它的流通导管配合或者通过套管或针或针头接口或输液装置或任何其它的流通导管配合限定,该流通导管例如由套管或针限定,适于提供通向容纳在容器中的药剂的流体通路。The outlet of the container may be adapted to cooperate with or be defined by a cannula or needle or needle hub or infusion set or any other flow conduit such as by A cannula or needle is defined, adapted to provide fluid access to the medicament contained in the container.
定量组件的驱动器可包括适于沿远端方向移动活塞的活塞杆。该活塞杆可包括比活塞更刚硬并适于与活塞的近面对表面的至少一部分并优选大部分邻接的元件,由此与活塞杆直接与活塞接合相比,通过活塞杆向该刚性元件施加的力施加到活塞的近端面的更大面积。The driver of the dosing assembly may comprise a piston rod adapted to move the piston in the distal direction. The piston rod may comprise a member that is stiffer than the piston and adapted to abut at least a portion, and preferably a substantial portion, of the proximally facing surface of the piston, whereby the direction of the rigid member is increased by the piston rod as compared to the direct engagement of the piston rod with the piston. The applied force is applied to a larger area of the proximal face of the piston.
定量组件限定第一紧固装置,在容器与定量组件的紧固期间,该第一紧固装置与容器的第二紧固装置接合。在一个实施例中,定量组件的第一紧固装置的近面对表面与容器的第二紧固装置的远面对表面接合。The dosing assembly defines first fastening means which engage second fastening means of the container during fastening of the container to the dosing assembly. In one embodiment, the proximal facing surface of the first fastening means of the dosing assembly engages the distal facing surface of the second fastening means of the container.
通过至少包括并行轴向和旋转运动的预定运动,诸如螺旋运动,容器可紧固到定量组件。通过并行的轴向和旋转运动引发的旋转运动小于一个回转,诸如小于120度,诸如小于90度,诸如小于60度。当第一紧固装置的近面对表面和第二紧固装置的远面对表面形成接合时,容器相对于定量组件的旋转促使容器和定量组件被拉向彼此。The container may be secured to the dosing assembly by a predetermined movement comprising at least parallel axial and rotational movement, such as a screw movement. The rotational movement induced by the parallel axial and rotational movement is less than one revolution, such as less than 120 degrees, such as less than 90 degrees, such as less than 60 degrees. Rotation of the container relative to the dosing assembly causes the container and the dosing assembly to be drawn towards each other when the proximal facing surface of the first fastening means and the distal facing surface of the second fastening means come into engagement.
在第一实施例中,定量组件的第一紧固装置限定了适于接收由容器的第二紧固装置限定的突出部的凹槽。在容器与定量组件的紧固期间,定量组件的第一紧固装置的大致近面对表面与容器的大致远面对表面接合。该预定运动通过接合面中的至少一个的形状限定。在又一实施例中,第二紧固装置限定了多个突出部,诸如两个、三个或四个,而第一紧固装置限定适于与突出部接合的多个相应凹槽。In a first embodiment, the first fastening means of the dosing assembly defines a recess adapted to receive the protrusion defined by the second fastening means of the container. During fastening of the container to the dosing assembly, the generally proximally facing surface of the first fastening means of the dosing assembly engages the generally distally facing surface of the container. The predetermined movement is defined by the shape of at least one of the joint surfaces. In yet another embodiment, the second fastening means defines a plurality of protrusions, such as two, three or four, and the first fastening means defines a plurality of corresponding grooves adapted to engage with the protrusions.
在第二实施例中,凹槽由容器限定,而突出部由定量组件限定。在第三实施例中,容器限定凹槽和突出部的组合,所述凹槽和突出部适于与由定量组件限定的相应突出部和凹槽接合。In a second embodiment, the recess is defined by the container and the protrusion is defined by the dosing assembly. In a third embodiment, the container defines a combination of grooves and protrusions adapted to engage corresponding protrusions and grooves defined by the dosing assembly.
在本发明的上下文中,术语“非对称图案”应被理解为使得当第一和第二紧固装置限定非对称图案时,在定量组件与容器之间仅存在一个相对旋转位置,其中第一紧固装置可容纳在第二紧固装置中/被第二紧固装置接收,由此以使容器能紧固到定量组件。容器和定量组件的相对旋转位置相对于设备的纵轴。In the context of the present invention, the term "asymmetrical pattern" is to be understood such that when the first and second fastening means define an asymmetrical pattern, there is only one relative rotational position between the dosing assembly and the container, wherein the first The fastening means may be housed in/received by the second fastening means, thereby enabling fastening of the container to the dosing assembly. The relative rotational positions of the container and dosing assembly are relative to the longitudinal axis of the device.
在一个实施例中,横剖面可与设备的轴向方向成直角,即相对于设备的轴向方向限定90度的角度。In one embodiment, the cross section may be at right angles to the axial direction of the device, ie define an angle of 90 degrees with respect to the axial direction of the device.
图案可通过至少两个突出部和/或至少两个凹槽来限定,因此平面可延伸通过所有至少两个突出部和/或所有至少两个凹槽。The pattern may be defined by at least two protrusions and/or at least two grooves, whereby a plane may extend through all at least two protrusions and/or all at least two grooves.
在一个实施例中,第一和第二紧固装置在垂直于设备的轴向方向的平面中限定非对称图案。在所述实施例中,第一和第二紧固装置的横剖面图案可基本相同。In one embodiment, the first and second fastening means define an asymmetrical pattern in a plane perpendicular to the axial direction of the device. In such embodiments, the cross-sectional patterns of the first and second fastening means may be substantially the same.
在一个实施例中,第一和第二紧固装置中的至少一个在垂直于设备的轴向方向的平面中限定少于两条对称线,诸如一条对称线。在特定的实施例中,第一和/或第二紧固装置限定一条延伸通过第一或第二紧固装置的凹槽或突出部的单一对称线。In one embodiment, at least one of the first and second fastening means defines less than two lines of symmetry, such as one line of symmetry, in a plane perpendicular to the axial direction of the device. In a particular embodiment, the first and/or second fastening means define a single line of symmetry extending through the groove or protrusion of the first or second fastening means.
此外,第一和第二紧固装置中的至少一个可不在垂直于设备的轴向方向的平面中限定对称线。Furthermore, at least one of the first and second fastening means may not define a line of symmetry in a plane perpendicular to the axial direction of the device.
在另一实施例中,至少两个突出部或凹槽中的每一个限定中心点,绕设备的纵轴的任意两个中心点之间的角度不同于180度。可将突出部的中心点定义为突出部自身的惯性中心,即不考虑横剖面的剩余部分的面积。另外,可将凹槽的中心点定义为所移除的质量/面积的惯性中心以限定凹槽。因此,在此实施例中,任意两个突出部/凹槽不是彼此完全相对地设置在定量组件的内或外表面上。In another embodiment, each of the at least two protrusions or grooves defines a center point, the angle between any two center points about the longitudinal axis of the device being different than 180 degrees. The center point of the protrusion may be defined as the center of inertia of the protrusion itself, ie regardless of the area of the remainder of the cross-section. Additionally, the center point of the groove can be defined as the inertial center of the mass/area removed to define the groove. Therefore, in this embodiment, any two protrusions/grooves are not disposed exactly opposite to each other on the inner or outer surface of the dosing assembly.
此外,至少两个突出部或凹槽中的两个或多个的周向范围可以不同。周向范围的意思是突出部/凹槽沿定量组件或容器的周向的长度。在一个实施例中,第一突出部的周向范围比第二突出部的周向范围大50%,诸如大100%,诸如大150%。而且,至少两个突出部或凹槽中的第一个可限定与至少两个突出部或凹槽中的第二个不同的形状。Furthermore, the circumferential extent of two or more of the at least two protrusions or grooves may differ. By circumferential extent is meant the length of the protrusion/recess along the circumference of the dosing assembly or container. In one embodiment, the circumferential extent of the first protrusion is 50%, such as 100%, such as 150%, greater than the circumferential extent of the second protrusion. Also, a first of the at least two protrusions or grooves may define a different shape than a second of the at least two protrusions or grooves.
在一个实施例中,至少两个突出部或凹槽中的一个或多个可限定诸如相对于设备的轴向方向的倾斜面。该倾斜面可限定垂直于装置的纵向方向并相对于所述纵轴成不同于90度的角度延伸的平面。In one embodiment, one or more of the at least two protrusions or grooves may define an inclined surface such as with respect to the axial direction of the device. The inclined plane may define a plane perpendicular to the longitudinal direction of the device and extending at an angle different from 90 degrees relative to said longitudinal axis.
医疗输送系统可包括轴向延伸的编码机构,该编码机构由容器的近端面和定量组件的相应远端面限定,容器的近端面限定一个或多个轴向延伸的突出体和/或缺口,在容器与定量组件的紧固期间,所述突出体和/或缺口与定量组件的远面对编码表面的匹配的一个或多个突出体和/或缺口相配合,由此如果远和近面对表面的每一个没限定一个或多个从突出体和/或缺口的预定组中选择的预定突出体和/或缺口,则防止所述预定运动。近表面可以是近端面。远表面可以是远端面。在一个实施例中,端面可以是环形的。The medical delivery system may include an axially extending coding mechanism defined by a proximal face of the container and a corresponding distal face of the dosing assembly, the proximal face of the container defining one or more axially extending protrusions and/or Notches, during the fastening of the container and the dosing assembly, the protrusions and/or notches cooperate with the matching one or more protrusions and/or notches of the far-facing coding surface of the dosing assembly, whereby if the far and Said predetermined movement is prevented if each of the proximally facing surfaces does not define one or more predetermined protrusions and/or indentations selected from a predetermined group of protrusions and/or indentations. The proximal surface may be a proximal surface. The distal surface may be a distal surface. In one embodiment, the end face may be annular.
在本发明的上下文中,术语“凹槽”和“突出部”仅与第一和第二紧固装置结合使用,而“缺口”和“突出体”仅与轴向延伸的编码机构结合使用。然而,“凹槽”和“缺口”将被看作同义词,而将“突出体”和“突出部”将被看作同义词。In the context of the present invention, the terms "groove" and "protrusion" are only used in connection with the first and second fastening means, while "indentation" and "protrusion" are only used in connection with the axially extending coding means. However, "groove" and "notch" shall be considered synonyms, and "protrusion" and "protrusion" shall be considered synonyms.
轴向延伸的编码机构可通过突出体/缺口的周向位置和/或突出体/缺口的轴向范围和/或突出体/缺口的径向范围和/或突出体/缺口的周向范围限定。在一个实施例中,周向位置、轴向、径向和周向范围中的至少一个用于指定药剂的第一特征,而周向位置、轴向、径向和周向范围中的剩余的至少一个用于指定药剂的第二特征。The axially extending coding mechanism can be defined by the circumferential position of the protrusion/notch and/or the axial extent of the protrusion/notch and/or the radial extent of the protrusion/notch and/or the circumferential extent of the protrusion/notch . In one embodiment, at least one of circumferential position, axial, radial and circumferential extent is used to specify a first characteristic of the medicament, while the remaining ones of circumferential position, axial, radial and circumferential extent are At least one second characteristic for specifying the medicament.
作为示例,缺口的位置可用于指定药剂的种类,而径向、轴向和周向范围中的至少一个可用于指定药剂的浓度。As an example, the location of the notch can be used to specify the type of agent, while at least one of the radial, axial and circumferential extent can be used to specify the concentration of the agent.
因此,将理解的是根据本发明的医疗输送系统提供多个编码几何图形,所述几何图形的每一个可用于指定不同的特征。作为示例,第一和第二紧固装置可用于指定药剂的第一预定特征,诸如药剂的种类,而轴向延伸的编码机构可用于指定药剂的第二预定特征,诸如药剂的浓度。可通过编码几何图形指定的特征的其它示例是:男性/女性药物;儿童/成人药物;预防药/治疗药,慢效/快效药。Accordingly, it will be appreciated that a medical delivery system according to the present invention provides a plurality of encoded geometries, each of which may be used to specify a different characteristic. As an example, the first and second fastening means may be used to designate a first predetermined characteristic of the medicament, such as the type of medicament, while the axially extending coding mechanism may be used to designate a second predetermined characteristic of the medicament, such as the concentration of the medicament. Other examples of features that can be specified by coded geometry are: Male/Female Drugs; Pediatric/Adult Drugs; Preventive/Therapeutic Drugs, Slow/Fast Acting Drugs.
在一个实施例中,容器包括至少两个从容器的近端面延伸的突出体,诸如两个、三个或四个,而定量组件包括至少两个适于与所述至少两个突出体相配合的缺口,诸如两个、三个或四个。In one embodiment, the container comprises at least two protrusions, such as two, three or four, extending from the proximal face of the container, and the dosing assembly comprises at least two protrusions adapted to cooperate with said at least two protrusions. Compatible notches, such as two, three or four.
所述预定运动的至少一部分可以是并行的轴向和旋转运动。在一个实施例中,该预定运动限定基本纯粹的轴向运动以及随后组合的并行轴向和旋转运动。该基本纯粹的轴向运动可用于指示使用者突出部和凹槽相匹配,由此它可防止使用者用导致凹槽或突出部损坏的力来执行组合运动。At least a portion of said predetermined movement may be parallel axial and rotational movement. In one embodiment, the predetermined movement defines a substantially pure axial movement followed by a combined parallel axial and rotational movement. This substantially pure axial movement can be used to indicate to the user that the lug and groove are mating, whereby it prevents the user from performing the combined movement with a force that would cause damage to either the groove or the lug.
可替代地,或者作为补充,预定运动限定组合的并行轴向和旋转运动以及随后的基本纯粹的旋转运动。该基本纯粹的旋转运动可用于指示使用者容器和定量组件实际上被彼此紧固。Alternatively, or in addition, the predetermined movement defines a combined parallel axial and rotational movement followed by a substantially pure rotational movement. This substantially pure rotational movement can be used to indicate to the user that the container and dosing assembly are actually secured to each other.
第一/第二紧固装置和/或轴向延伸的编码机构可适于防止预定运动的轴向和/或旋转运动的至少一部分,以便防止容器与定量组件的联接。当容器不能联接到定量组件时,定量组件不能用于喷出药剂。The first/second fastening means and/or the axially extending coding mechanism may be adapted to prevent at least part of the axial and/or rotational movement of the intended movement in order to prevent coupling of the container with the dosing assembly. When the container cannot be coupled to the dosing assembly, the dosing assembly cannot be used to eject the medicament.
在一个实施例中,容器包括筒固定器和限定所述腔室的筒。第二紧固装置可由该筒固定器限定或者可附接到筒固定器。而且,缺口/突出体和/或突出部/凹槽可由筒固定器限定。筒和筒固定器可以是两个独立元件,并且筒可摩擦地保持在筒固定器中。在一个实施例中,筒由玻璃制成,而筒固定器由非玻璃材料制成,用于保护玻璃筒。筒不可拆卸地保持在筒固定器中,从而如果将筒从筒固定器中拆下,则不能用手而没有工具的情况下重新附接该筒。这提供了如下优点:当筒已经变空时,不能再使用筒固定器,因此具有错误药剂的筒不能插入筒固定器中并使用定量组件进行分配。筒固定器和筒可限定整体元件,即形成没有接缝的一个元件。此整体元件可形成为由诸如Topas(R)或聚丙烯的合成树脂制成的模制品。此模制品可包括在模制期间形成的紧固和编码元件。然而,可使用任何适于长期存储待容纳在容器中的特定药物的材料。In one embodiment, the container comprises a cartridge holder and a cartridge defining said chamber. The second fastening means may be defined by the cartridge holder or may be attachable to the cartridge holder. Also, notches/protrusions and/or protrusions/grooves may be defined by the cartridge holder. The cartridge and cartridge holder may be two separate elements, with the cartridge frictionally retained in the cartridge holder. In one embodiment, the cartridge is made of glass and the cartridge holder is made of a non-glass material to protect the glass cartridge. The cartridge is not detachably held in the cartridge holder so that if the cartridge is detached from the cartridge holder it cannot be reattached by hand without tools. This provides the advantage that the cartridge holder cannot be used anymore when the cartridge has become empty, so a cartridge with the wrong medicament cannot be inserted into the cartridge holder and dispensed using the dosing assembly. The cartridge holder and cartridge may define a unitary element, ie form one element without seams. This integral element may be formed as a molding made of a synthetic resin such as Topas(R) or polypropylene. This molded article may include fastening and coding elements formed during moulding. However, any material suitable for long-term storage of the particular drug to be contained in the container may be used.
如上所述,所述预定运动的至少一部分可以是并行的轴向和旋转运动。而且,第一和/或第二紧固装置可适于防止预定运动的轴向和/或旋转运动的一部分,由此如果第一和第二紧固装置的每一个没限定预定的非对称编码几何图形,则防止容器与定量组件的联接。第一和/或第二紧固装置的编码几何图形可由下列中的至少一项限定:第一和第二紧固装置的周向范围、第一和第二紧固装置的轴向范围、第一和第二紧固装置的径向范围以及第一和第二紧固装置的周向位置。As noted above, at least a portion of the predetermined movement may be parallel axial and rotational movement. Furthermore, the first and/or second fastening means may be adapted to prevent part of the axial and/or rotational movement of the intended movement, whereby if each of the first and second fastening means does not define a predetermined asymmetrical code geometry, prevents the coupling of the container to the quantitative component. The coded geometry of the first and/or second fastening means may be defined by at least one of the following: the circumferential extent of the first and second fastening means, the axial extent of the first and second fastening means, the The radial extent of the first and second fastening means and the circumferential position of the first and second fastening means.
一个实施例包括:One embodiment includes:
具有上述特征和/或元件的任一个的第一容器,该第一容器适于紧固到具有上述特征和/或元件的任一个的第一定量组件;以及A first container having any of the aforementioned features and/or elements adapted to be fastened to a first dosing assembly having any of the aforementioned features and/or elements; and
具有上述特征和/或元件的任一个的第二容器,该第二容器适于紧固到具有上述特征和/或元件的任一个的第二定量组件;以及A second container having any of the aforementioned features and/or elements adapted to be fastened to a second dosing assembly having any of the aforementioned features and/or elements; and
其中下列中的至少两项:At least two of the following:
第一定量组件的第一紧固装置,the first fastening device of the first dosing assembly,
第二定量组件的第一紧固装置,the first fastening device of the second dosing assembly,
第一容器的第二紧固装置,以及the second fastening device of the first container, and
第二容器的第二紧固装置,the second fastening means of the second container,
适于防止第一定量组件和第二容器彼此紧固,以及防止第二定量组件和第一容器彼此紧固。Adapted to prevent the first dosing assembly and the second container from being fastened to each other, and to prevent the second dosing assembly and the first container from being fastened to each other.
此外,所需用于将第一容器与第一定量组件联接和分开以及用于将第二容器联接到第二定量组件的预定运动可基本相同。Furthermore, the predetermined movements required for coupling and decoupling the first container to the first dosing assembly and for coupling the second container to the second dosing assembly may be substantially the same.
在第二方面中,本发明涉及一种适合在根据本发明第一方面的医疗输送系统中使用(适用于根据本发明第一方面的医疗输送系统)的容器。In a second aspect, the invention relates to a container suitable for use in (for a medical delivery system according to the first aspect of the invention) a medical delivery system according to the first aspect of the invention.
将理解的是根据第二方面的发明可包括根据第一方面的发明的任何特征和/或元件。特别地,第二方面的容器可包括根据本发明第一方面的容器的任何特征和/或元件。It will be appreciated that the invention according to the second aspect may comprise any features and/or elements of the invention according to the first aspect. In particular, the container of the second aspect may comprise any of the features and/or elements of the container according to the first aspect of the invention.
在第三方面中,本发明涉及一种适合在根据本发明第一方面的医疗输送系统中使用(适用于根据本发明第一方面的医疗输送系统)的定量组件。In a third aspect, the invention relates to a dosing assembly suitable for use in (for a medical delivery system according to the first aspect of the invention) a medical delivery system according to the first aspect of the invention.
将理解的是根据第三方面的发明可包括根据第一方面的发明的任何特征和/或元件。特别地,第三方面的定量组件可包括根据本发明第一方面的定量组件的任何特征和/或元件。It will be appreciated that the invention according to the third aspect may comprise any features and/or elements of the invention according to the first aspect. In particular, the dosing assembly of the third aspect may comprise any of the features and/or elements of the dosing assembly according to the first aspect of the invention.
附图说明 Description of drawings
现在将参照附图对本发明进行更详细地描述,其中:The invention will now be described in more detail with reference to the accompanying drawings, in which:
图1和图2公开了现有技术中公知的注射器装置,Figures 1 and 2 disclose syringe devices known in the prior art,
图3公开了根据本发明的医疗输送系统,以及Figure 3 discloses a medical delivery system according to the invention, and
图4和图5公开了分别具有两个和三个突出部的容器,Figures 4 and 5 disclose containers with two and three protrusions respectively,
图6-12公开了具有两个、三个或四个突出部的容器的横剖面,Figures 6-12 disclose cross-sections of containers with two, three or four protrusions,
图13a和图13b公开了具有轴向延伸缺口的实施例,在紧固期间,所述轴向延伸缺口被旋转至与轴向延伸的突出体接合。Figures 13a and 13b disclose an embodiment having an axially extending notch which is rotated into engagement with the axially extending protrusion during fastening.
具体实施方式 Detailed ways
图1和图2公开了一种注射器装置100,该注射器装置已在本申请提交前被申请人以“NovoPen4”的名字投放欧洲和美国市场。注射器装置100包括近端部102和远端部104。在使用中,近端部102形成剂量设定单元(未示出)的一部分,该剂量设定单元包括延伸通过近端部102的通道(未示出)的活塞杆(未示出)。活塞杆的中心轴线与虚线106重合。在使用中,远端部104限定隔室108,用于容纳含有药剂的贮液器(未示出)。远端部104包括两个脊部110,每个脊部在远端部的每侧,通过将脊部110前移到近端部102的匹配轨道112中,所述脊部用于将远端部104固定到近端部102。所述轨道限定在近端部102的内表面114上。Figures 1 and 2 disclose an
图3公开了包括容器202和定量组件204(为简单起见,仅公开了定量组件的一部分)的医疗输送系统200。容器202限定两个突出部206’、206”,所述突出部适于与定量组件204的匹配凹槽208’、208”接合。当突出部206’、206”前移到凹槽208’、208”中时,容器和定量组件可旋转,由此容器的远面对表面210a和定量组件212的近面对表面212之间的接合促使定量组件和容器在执行并行轴向和旋转运动的同时被拉向彼此。该并行运动由倾斜近面对表面212引起,该倾斜近面对表面首先与远面对表面210a接合并随后与远面对表面210b接合。Figure 3 discloses a
医疗输送系统包括三个轴向延伸的突出体214,在图3的第一实施例中,所述突出体限定了旋转止面216,在并行运动期间,所述旋转止面适于与定量组件的相应止面(未示出)接合以便防止进一步的旋转运动。The medical delivery system comprises three axially extending
在图3的第二实施例中,突出体214限定轴向延伸的编码机构的第一部件,该编码机构还包括设置在定量组件中的轴向延伸的缺口(未示出)。In the second embodiment of FIG. 3 , the
突出部206’、206”包括两个倾斜表面218,例如在患者试图将容器紧固到它不能被固定到的定量组件的情况下,所述倾斜表面防止突出部与凹槽之间的无意接合。因此,如果使用者使容器和定量组件倾斜(使得它们的纵轴不重合而是彼此相交),由此一个突出部能前移到凹槽中,则容器与定量组件之间的相对旋转促使突出部由于倾斜表面218而被迫从凹槽中脱出。The
图4公开了容器202的横剖面和正视图,该容器包括以非对称图案设置的两个突出部206’、206”,该非对称图案在图5(是否应为图4)的横剖视图中公开并且不包括对称线。第一突出部206’的周向范围205’大于第二突出部206”的周向范围205”。由于非对称性,所以只有当容器相对于定量组件设置在一个单一预定旋转位置中时,容器才能紧固到匹配的定量组件。Figure 4 discloses a cross-section and a front view of a
图5公开了具有三个突出部206’、206”、206”’的容器202的横剖面和正视图。这些突出部没限定对称线并且第一突出部206’的周向范围大于第三突出部206”’的周向范围,第三突出部206”’的周向范围又大于第二突出部206”的周向范围。Figure 5 discloses a cross-section and a front view of a
图6-8公开了三个容器,所述容器的每一个包括三个突出部206’、206”、206”’。在图6中,任意两个突出部之间(绕中心轴线220)的角度是120度并且突出部具有相同的形状。在图7中,第一和第二突出部206’、206”具有相同的形状,而第三突出部206”’的形状与第一和第二突出部不同。此外,任意两个突出部之间的角度也是120度并且容器限定了一条对称线222。在第三实施例中,第一突出部206’大于第二突出部206”,第二突出部206”大于第三突出部206”’,因此横剖面没有限定对称线。Figures 6-8 disclose three containers, each of which includes three
突出部可限定如关于图8中公开的中心点224。中心点可定义为突出部的惯性中心,并且在图8中,绕中心轴线220,任意中心点之间的角度是120度,因此不同于180度。The protrusion may define a
图9的容器包括四个以90度旋转间隔的突出部206’、206”、206”’、206””。此外,由于突出部具有相同的形状,所以容器的横剖面限定了四条对称线222。图10的容器包括两个突出部206’、206”并因此限定了两条对称线。The container of Figure 9 includes four
在图11中,容器包括三个相同的突出部206’、206”、206”’并限定了一条对称线。而且,该单一对称线延伸通过突出部中的一个。在图12中,突出部中的一个的位置相对于图11的容器发生变化,由此该容器没有限定对称线。In Fig. 11, the container comprises three
图13a的容器202适于通过联合的旋转和轴向运动而紧固到图13b的定量组件204。容器202限定了从容器202的侧壁226延伸的径向延伸突出部206和从近端面230沿远端方向轴向延伸到侧壁226中的缺口228。轴向延伸的缺口228限定了底面232、止面234和倾斜面236。定量组件204限定了凹槽208,用于在容器202与定量组件204的紧固期间接收突出部206。在图13b的实施例中,凹槽208由从定量组件204的侧壁240径向向外且沿着定量组件204的中心的方向延伸的突出部238限定。倾斜面236成形为使定量组件204的轴向延伸突出部242能移动到容器202的轴向延伸缺口228中(并因此被轴向延伸缺口228接收)。缺口228的止面234适于与定量组件204的突出部242的相应止面244接合以便防止容器202与定量组件204之间的进一步相对旋转。两个止面234、244之间的邻接为使用者提供容器202紧固到定量组件204的事实的触觉指示。The
定量组件的突出部238成形为使得凹槽208不限定止面,因此与图13b的定量组件相似但没有轴向延伸突出部242的定量组件将不为使用者提供容器202紧固到此定量组件204的事实的触觉指示。因此,图13a的容器202不能紧固到与图13b的定量组件相似但不限定突出部242的定量组件204。这防止容器202被紧固到此构造的定量组件204。The
与图13a的容器相似但不限定轴向延伸缺口228的容器可采用两种形式。第一形式,其中近端面230限定在与图13a中的表面230相同的轴向高度处,以及第二形式,其中近端面230限定在与图13a中的底面232相同的轴向高度处。第一与第二形式之间的差别是表面230与突出部206之间的距离。A container similar to that of Figure 13a but not defining an axially extending notch 228 may take two forms. A first form in which the proximal face 230 is defined at the same axial height as the surface 230 in Figure 13a, and a second form in which the proximal face 230 is defined at the same axial height as the bottom face 232 in Figure 13a . The difference between the first and second forms is the distance between surface 230 and
因为容器202的近端面230将邻接突出部242的远面对表面246,由此突出部206不能容纳在凹槽208中或者仅能部分地,即以不足以将容器202紧固到定量组件204的方式移动到凹槽208中,所以第一形式,即其中近端面230限定在与图13a的近端面230相同的轴向高度处并且没有缺口228的容器202不能被紧固到图13b的定量组件。Because the proximal face 230 of the
因为没有向使用者提供使他能确定容器202何时紧固到定量组件204的触觉指示,所以第二形式,即其中近端面230限定在与图13a中的底面232相同的轴向高度处并且不限定缺口228的容器202不能被紧固到不限定轴向延伸突出部242的定量组件204,反之亦然。因此,使用者将继续容器202与定量组件204之间的相对旋转,由此突出部206将从凹槽208中移出,从而容器202没有紧固到定量组件204。Because no tactile indication is provided to the user to enable him to determine when the
从上文中将理解地是:因为不指定与预定定量组件204结合使用的容器202不能被紧固到此定量组件204,所以图13a和图13b的实施例提高了使用者的安全性。因此,防止使用者将具有错误药剂或错误浓度的正确药剂的容器202附接到定量组件204,从而防止喷射这种药剂。From the above it will be appreciated that the embodiment of Figures 13a and 13b increases user safety because a
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US5611783A (en) * | 1991-11-29 | 1997-03-18 | Novo Nordisk A/S | Pen-shaped syringe |
US5957896A (en) * | 1997-08-11 | 1999-09-28 | Becton, Dickinson And Company | Medication delivery pen |
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US4280723A (en) * | 1978-07-26 | 1981-07-28 | Moldestad Jon P | Safety device for hose connections |
US5611783A (en) * | 1991-11-29 | 1997-03-18 | Novo Nordisk A/S | Pen-shaped syringe |
US5957896A (en) * | 1997-08-11 | 1999-09-28 | Becton, Dickinson And Company | Medication delivery pen |
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