JPH0744430U - Infusion container - Google Patents

Abstract

(57) [Summary] [Purpose] In an infusion container consisting of a container containing a drug solution and a vial and a mouth member having a means for communicating the container, at the time of communication, contamination of impurities and addition of rubber stopper additive from the joint It is to provide an infusion container that is free from elution and the like. [Structure] A synthetic resin container body 11 having upper and lower ends, which is filled with a solution for infusion, is provided with a mouth 9 provided with a membrane 8 in a liquid-tight manner, and is filled with a drug for infusion. In addition, a puncture needle 5 for communicating the vial 1 with the container body 11 is built in, and the opening 3 side for vial mounting is removably capped (2) at the time of mounting to keep the aseptic state. An infusion container in which the synthetic resin mouth member 4 is heat-coupled to the mouth portion 9.

Description

[Detailed description of the device]

[0001]

[Industrial applications]

 The present invention relates to an infusion container used for drip injection, and more particularly to an infusion container in which a synthetic resin container and a via are held so as to be communicated with each other by a puncture needle.

[0002]

[Prior art]

 Conventionally, infusion containers used for instillation are of the type that is filled with one type of drug solution or separated and filled with two or more types of drug solution, and the drug that is filled in a vial is dissolved and diluted. There is a type that separates and fills the chemical liquid. The former infusion containers of the one-type liquid filling type and the multiple-type liquid separating / filling type are generally made of a synthetic resin bag filled with a drug solution, a tubular port heat-sealed at the mouth of one end of the bag, and its It is composed of a rubber stopper and is subjected to high-pressure steam sterilization at an arbitrary temperature condition to maintain the sterility of the content liquid (chemical liquid). On the other hand, the latter drug / solution separation / filling type infusion container is composed of a bag filled with a drug solution and sealed with a rubber stopper, and a mouth member with a built-in puncture needle that communicates the vial with the bag. After the bag and the bag are sterilized separately, the two are joined.

[0003]

[Problems to be solved by the device]

 However, at the mouth of the synthetic resin container body of the latter infusion container, a rubber stopper was used at the joint with the mouth member, so the container body and the mouth member could not be joined in a sterilized state in advance, and Since it was not possible to maintain the inside of the member in the same state, there were problems such as the inclusion of impurities and the elution of the additive in the rubber plug when communicating with each other.

The object of the present invention is to solve the above-mentioned drawbacks of the conventional infusion container, and to provide a communication container in which an infusion container including a drug solution and a mouth member having a means for communicating the vial and the container body are connected. Another object of the present invention is to provide an infusion container which is free from the possibility that impurities are sometimes mixed in from the joint and that additives such as rubber stoppers do not elute.

[0005]

[Means for Solving the Problems]

 In order to achieve the above-mentioned object, the infusion container of the present invention is provided with a membrane-tight opening at one end of a synthetic resin container body having upper and lower ends filled with an infusion solution. Incorporates a puncture needle to connect the vial filled with the transfusion drug with the container body, and the opening side for mounting the vial is removably capped during mounting to maintain the sterile condition. The synthetic resin mouth member is bonded and fixed in advance to the above-mentioned mouth portion in an aseptic state.

As a structure for providing the membrane in a liquid-tight manner at the mouth, a tubular port integrally formed on the inner peripheral surface in a liquid-tight manner is heat-sealed to one end of the container body. Alternatively, a lid having a bottom surface of a membrane may be fitted into the outer opening end of the cylindrical port fused to one end of the container body. In these cases, it is desirable that the membrane be provided so as to be located slightly inward of the outer open end of the cylindrical port.

[0007]

[Action]

 A synthetic resin container body filled with a solution for infusion is attached to one end with a liquid-tight membrane opening to sterilize the whole body, and a synthetic resin mouthpiece is joined to this opening. To do. This mouth member has a built-in puncture needle for communicating the vial with the container body, and the opening side for mounting the vial is removably capped at the time of mounting and is sterilized to ensure a sterile condition. Holding Therefore, the inside of the infusion container before use is kept sterile. When using, insert the vial into the upper part of the puncture needle, and then insert the lower part of the puncture needle into the membrane. Therefore, there is no possibility that impurities will be mixed in during communication or additives and the like will be eluted.

[0008]

【Example】

 FIG. 1 is a part view showing an embodiment of the infusion container of the present invention, and the mouth member is shown in a sectional view. In the figure, 1 is a vial filled with an infusion agent, 11 is an entire synthetic resin container body having upper and lower ends, and a synthetic resin film bag-like container 10 is provided with the infusion agent in the vial. It is filled with a solution for infusion to dissolve it, and there is a rubber stopper (not shown) at the lower end for inserting the piercing needle on the infusion tube side, and the membrane 8 is made liquid-tight at the upper end. The provided cylindrical port 9a is heat-sealed to form the mouth portion 9 for joining the synthetic resin mouth members, and in this state, sterilization treatment (for example, high-pressure steam sterilization) is performed.

The membrane 8 is preferably formed integrally with the tubular port 9a, but, as will be described later, another member having a membrane formed thereon may be fitted to the tubular port 9a. Further, the membrane 8 is preferably provided slightly inside from the upper edge of the tubular port 9a in order to prevent damage at the time of joining with the synthetic resin mouth member. Although the thickness of this membrane depends on the material, it is preferably 0.01 to 0.5 mm. If it is less than 0.01 mm, the membrane may be broken before use due to the pressure from the outside of the container. If it exceeds, it becomes difficult for the puncture needle to pierce, and work efficiency during communication deteriorates.

Reference numeral 4 denotes a synthetic resin mouth member joined to the mouth portion 9, which has a puncture needle 5 for communicating the vial 1 and the container body 11 inside the mouth member body 12. The side of the opening 3 for mounting the vial is sealed with the overfilm 2 so that it can be removed when the vial is mounted, and the side of the opening 6 for bonding to the mouth 9 is sealed with sterilized paper 7 and sterilized in this state. Aseptic condition is maintained by processing (for example, ethylene oxide gas sterilization). When the mouth member 4 is joined to the mouth portion 9, the sterilized paper 7 is peeled and joined as shown in FIG. As an example of sealing sterilized paper as a method of keeping the inside of the mouth member 4 in a sterile state until the mouth member 4 is joined to the mouth portion 9, the sterilized paper is not sealed to each mouth member. Since it is complicated except for special cases, one by one without sealing the sterilized paper on the above-mentioned mouth member or a plurality of them are put together in a container such as a bag that can be sealed and sterilized in that state. A preferable method is to seal the container, maintain the sterilized state, and bring it to the step of contacting with the mouth 9.

The internal structure of the mouth member, that is, the means for communicating the vial 1 and the container body 11 is not particularly limited, and for example, the means already proposed in Japanese Patent Laid-Open No. 2-1277 can be used. You can also Also, the method of joining the mouth member 4 to the mouth portion 9 is not particularly limited as long as this portion is sterilized, but after the vial 1 and the bag-shaped container 10 are connected by the puncture needle 5. Considering the liquid sealability, it is preferable to bond them by heat fusion or ultrasonic fusion.

At the time of use, the vial 1 is attached by peeling off the overfilm 2 of the opening 3 as shown in FIG. 3 in a sterile room, and the upper end of the puncture needle 5 is placed on the vial 1 as shown in FIG. Pierce the section. When the vial 1 is further lowered in this state, the lower end of the puncture needle 5 penetrates the membrane 8 and the vial 1 and the bag-shaped container 10 communicate with each other as shown in FIG. The solution for infusion in the container 10 is caused to flow into the vial 1 to dissolve the drug for infusion, and is refluxed in the bag-shaped container 10.

FIG. 6 shows another embodiment for providing the membrane 8 in a liquid-tight manner at the mouth portion 9, and the outside (upper end) of the cylindrical port 9 a fused to one end of the container body 11. At the open end, a stopper cap-shaped lid 8a integrally formed with the membrane 8 on the bottom surface was fitted and heat-sealed. Therefore, the membrane 8 provided in this manner is also positioned slightly inward (downward) from the upper end opening end of the tubular port 9a, and there is no risk of damage when the synthetic resin mouth member 4 is joined. .

[0014]

[Effect of device]

 According to the infusion container of the present invention, the synthetic resin container filled with the infusion solution is provided with a membrane-tight mouth part at one end, and the whole is sterilized. A synthetic resin mouth member is joined to the part in a sterilized state.The mouth member has a built-in puncture needle for communicating the vial and the container body, and the opening side for vial mounting is It is capped so that it can be removed when it is attached, and is sterilized to maintain its sterility. Therefore, the inside of the infusion container before use is kept sterile. Therefore, when the vial is pierced through the upper part of the puncture needle at the time of use and then the lower part of the puncture needle is pierced and communicated with the membrane, there is no risk of impurities being mixed in or additives being eluted.

[Brief description of drawings]

FIG. 1 is an exploded view of parts showing an embodiment of an infusion container according to the present invention.

FIG. 2 is a partial cross-sectional side view showing a state in which a mouth member is joined to a mouth portion of a container body.

FIG. 3 is a partial cross-sectional side view showing a process of mounting a vial on a mouth member.

FIG. 4 is a partial cross-sectional side view showing a state in which a vial is inserted into a puncture needle.

FIG. 5 is a partial cross-sectional side view showing a state in which a puncture needle pierces a membrane.

FIG. 6 is a partial cross-sectional side view of a main portion showing another embodiment in which a membrane is provided at a mouth portion.

[Explanation of symbols]

 1 vial 2 overfilm 3 opening for mounting vial 4 synthetic resin mouth member 5 puncture needle 6 opening for joining to mouth 7 sterilized paper 8 membrane 8a lid 9 mouth 9a tubular port 10 bag-shaped container 11 Synthetic resin container body

─────────────────────────────────────────────────── ─── Continuation of the front page (51) Int.Cl. ⁶ Identification number Reference number within the agency FI technical display location B65D 83/00 G (72) Inventor Masahiro Tamura 8-12, Uzumasa Shimokakuta-cho, Ukyo-ku, Kyoto City, Kyoto Prefecture

Claims (4)

[Scope of utility model registration request] 1. A synthetic resin container body, which is filled with a solution for infusion and has upper and lower ends, has a mouth portion provided with a membrane in a liquid-tight manner at one end, and the mouth portion is made of a synthetic resin mouth. The synthetic resin mouth member has a built-in puncture needle for communicating the vial filled with the infusion agent with the container body, and the opening side for mounting the vial at the time of mounting the member. An infusion container, which is removable and is in a sterile state. 2. A structure for providing a membrane in a liquid-tight manner at a mouth portion is constructed by heat-sealing a cylindrical port integrally formed with the inner peripheral surface of the membrane in a liquid-tight manner to one end of a container body. The infusion container according to claim 1, wherein the infusion container is provided. 3. A structure for providing a membrane in a liquid-tight manner at a mouth is such that a lid having a bottom surface is a membrane is fitted into an outer opening end of a cylindrical port fused to one end of a container body. The infusion container according to claim 1, which is configured as follows. 4. The infusion container according to claim 2, wherein the membrane is located slightly inward of the outer opening end of the tubular port.