JPH0670737U - Infusion container - Google Patents

Abstract

(57) [Summary] [Purpose] The mouth member of a bag-like container that can be connected to a vial and the vial can be reliably separated when not in use, and the vial can be connected to the above-mentioned mouth member. (EN) Provided is an infusion container having a simple structure which can be operated in a sealed state. An infusion container 1 is provided with a synthetic resin mouth member 5 configured to be able to connect a vial 4 at an open end of a synthetic resin bag-shaped container 2,
The upper portion of the mouth member 5 is joined to the opening of the outer casing 6 made of a flexible material that seals the vial 4, and the vial 4 and the mouth member 5 in the outer casing 6 are held in a separated state. For this purpose, the outer packaging container 6 was clamped from the outside by a clamping clip 7.

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 held so that a synthetic resin bag-like container and a vial are aseptically connected by a puncture needle.

[0002]

[Prior art]

 When infusing in a hospital, etc., when the powdered or liquid drug filled in the vial is used after being dissolved or diluted with the drug solution in the drug solution container, the vial side and the drug solution container side are used. The operation of connecting with a puncture needle, a connecting tube, etc., first transferring the drug solution to the side of the vial to dissolve or dilute the drug, and then transferring it to the drug solution container side and further diluting it is repeated. However, conventionally, during the work of connecting these two containers, the vial is housed in a capsule so that the drug is not contaminated by the invasion of external bacteria from the outside air, and this is put into the mouth member of the flexible drug solution container. The infusion container is attached to the container, and the vial bottle is pushed down while it is housed in the capsule to pierce the stopper of the vial bottle and the mouth of the flexible drug solution container with the puncture needle to connect them together. Has been proposed (for example, Japanese Patent Laid-Open No. 2-1277). This conventional proposal has the advantage that it can be communicated with the flexible drug solution container by simply pushing down the vial inside the capsule and there is no risk of invasion of germs, but it covers the vial bottle. It requires a capsule, a vial holder, and a complicated internal structure to push down and slide in a straight line. Further, there is a problem that the vial bottle cannot be taken out from the capsule after the infusion container is used, and the glass product vial bottle and the resin capsule cannot be separately disposed.

[0003]

[Problems to be solved by the device]

 The object of the present invention is to solve the above-mentioned drawbacks of the conventional infusion container, and to transfer the vial and the bag-shaped container into which the drug in the vial should be transferred using a puncture needle without fear of invasion of germs and the like. It is an infusion container with a simple structure that can be reliably separated when the container is not in use, and the operation of connecting the vial and bag-like container can be done in an aseptic state. An object of the present invention is to provide an infusion container that can be easily separated and discarded from a manufactured vial bottle.

[0004]

[Means for Solving the Problems]

 As a result of various studies to achieve the above object, it was found that the solution can be achieved by using a flexible bag-shaped outer container containing a vial without using a capsule, and the present invention was completed. did. That is, the gist of the present invention is an infusion container comprising a synthetic resin bag-shaped container, to which an open end of a synthetic resin bag-shaped container is fitted with a synthetic resin mouth member having a puncture needle for communicating between the vial and the bag-shaped container. The mouth of the flexible outer container containing the vial is tightly joined to the vial to seal the vial, and the outer container is equipped with a detachable holding clip to prevent contact between the vial and the mouth member from the outside. It is in a sandwiched infusion container. The details of the present invention will be described below.

The synthetic resin bag-like container according to the present invention is preferably a film or sheet made of a flexible resin such as polyethylene resin, vinyl chloride resin, or ethylene-vinyl acetate resin. In particular, a polyethylene resin is preferable because it does not generate an acid due to leaching of the resin additive or hydrolysis of the resin. A synthetic resin mouth member is attached to the open end of the synthetic resin bag-like container. As an aspect of this attachment, other than the one in which the mouth member is directly inserted into the open end of the bag-like container and heat-welded In order to facilitate the attachment of the mouth member to the bag-shaped container, it is also effective to heat-bond the mouth-member-attaching plug body to the bag-shaped container in advance. As a method of attaching the mouth member to the plug body, there are methods such as simple surface bonding and fitting or screwing. Further, a synthetic resin mouth member having a puncture needle that connects the vial and the bag-like container is attached to this stopper, but a stopper having an opening in advance may be used. It may be closed with a thin film that can be pierced with a needle. In the present invention, as described above, the mounting structure of the open end of the synthetic resin bag-shaped container and the synthetic resin mouth member is not particularly limited, and may be the one described in JP-A-2-12777. .

A flexible outer container containing a vial bottle is attached to the synthetic resin mouth member in a hermetically sealed state, and if it is not necessary to connect the vial bottle and the synthetic resin bag-like container, From the outside of the flexible outer packaging container, the vial bottle is gripped by hand and the puncture needle is pierced into the spout. The outer envelope container suitable for such work is preferably a transparent material that can be observed from the outside. Therefore, it is preferable that the transparency is good, but even if it is translucent, it is sufficient if the vial bottle inside can be seen. In addition, since manual work is performed through the outer envelope container, a low-rigidity material that is easy to work is preferable. Therefore, a bag-shaped product made of a polyolefin film or a film made of ethylene vinyl acetate resin is preferable.

The above-mentioned synthetic resin mouth member and the outer container can be adhered and joined to each other by a usual heat fusion method, an ultrasonic adhesion method, a high frequency adhesion method, or the like. It is also possible to use a close-bonding method by tightening in a strip shape. In the case of using an adhesive, it cannot be said to be preferable, because undesired gas or the components of the adhesive enter the outer envelope container. It is most preferable that the synthetic resin mouth member and the outer container are joined in an aseptic state by treating each of them in an aseptic chamber and then in that state.

The vial stopper and the puncture needle should not be in contact with each other until they are pierced by the puncture needle. This is to prevent damage to the puncture needle and the vial stopper. As a countermeasure against this, in the present invention, a means for holding the outer container from the outside with a holding clip and keeping the vial bottle and the puncture needle separated is adopted. However, the sandwiching by the sandwiching clip is sufficient if the vial bottle does not come into contact with the puncture needle of the mouth member, and it is not always necessary to completely separate it into two chambers. Moreover, it is sufficient to prevent the contact between the stopper of the vial bottle and the puncture needle as described above, and the shape and structure of the clip do not limit the invention.

The holding clip is provided with a “C” ring-shaped fitting piece on the lower part of the opposite holding piece, and the fitting piece is fitted to the outer periphery of the mouth member so as to be securely held. This is preferable because the fixability of the portion of the container containing the vial bottle is improved, the freedom between the container and the synthetic resin bag-like container is reduced, and the outer container and the mouth member are less damaged. During infusion work (mixing of medicines in vial bottle), the clip can be removed by removing this "C" ring-shaped fitting piece.

Further, a cut portion for rupture and an engaging portion for suspending are provided in, for example, an upper end seal portion of the outer envelope container, and the engaging portion is hung by hooks or the like when using drip infusion. After use, the outer container can be torn from the cut portion and the vial can be taken out and separated.

[0011]

[Action]

 On the top of the mouth member attached to the synthetic resin bag-shaped container, the opening of the outer packaging container made of a flexible material that seals the vial is tightly joined, and the outer packaging container is clamped from the outside by the clamping clip. Since the vial and the mouth member in the outer envelope container are in a separated state, the vial bottle does not collide with the mouth member unintentionally when not in use, and the puncture needle placed in the mouth member. There is no risk that the stopper of the vial will come into contact with. When the clip is removed during use, the vial in the outer envelope container can be freely moved, so that the mouth of the vial is fitted into the mouth member and connected to the synthetic resin bag-like container by the puncture needle. After using, tear off from the cut part that was previously formed or if necessary, take out the vial bottle inside the outer envelope container, glass (vial bottle) and resin molded product (outer envelope container, bag-like container and mouth member etc.) ) Can be sorted and discarded.

[0012]

【Example】

 FIG. 1 is a perspective view of a partially cutaway bag-shaped container in one embodiment of the infusion container of the present invention, in which 1 represents an infusion container, and an opening end of a bag-shaped container 2 formed of a synthetic resin film. The stopper body 3 is heat-sealed to the stopper body 3, and the stopper body 3 is provided with a synthetic resin mouth member 5 configured so that the vial bottle 4 can be connected thereto. It is possible to adopt various configurations of the mouth member 5 itself, and for example, we previously proposed a medical bag provided with this mouth member (Actual Publication No. 4-71940). When the vial bottle 4 is joined to the mouth member 5, the vial stopper 14 of the vial is pierced by one of the cutting edges of the puncture needle 15 provided in the mouth member 5, as shown in FIG. 2 described below. It suffices that the other blade tip is configured to pierce and communicate with the plug body side of the bag-shaped container. In the present invention, the opening of the outer envelope container 6 made of a transparent and flexible material for sealing a vial is fusion-bonded to the outer peripheral surface of the upper part of the mouth member 5, and the clip near the joint 6a of the outer envelope container is clamped. 7, the vial 4 and the mouth member 5 in the outer envelope container 6 are held in a separated state.

The outer container 6 is formed of a transparent synthetic resin film, and the lower opening portion of the tubular film is brought into close contact with the outer periphery of the upper portion of the mouth member 5 by heat contraction, and the vial container 4 is housed inside and the upper opening portion is opened. Heat seal parts. These operations are performed in a sterilization room or the like, and the sealed vial bottle 4 is moved upward and the vicinity of the joint portion 6a is clamped by the clamping clip 7. A cut portion 8 for tearing and a locking hole 9 for suspension are provided in the heat seal portion 6b of the outer container 6. The holding clip 7 is made of synthetic resin, and the rear ends of the opposing holding pieces 7a, 7a are connected by a curved connecting portion 7b so as to have a spring property, and a lower portion thereof has a "C" ring shape. The fitting piece 7c is provided, and the fitting piece 7c is fitted to the outer periphery of the upper portion of the mouth member 5, for example, the outer periphery of the above-mentioned close contact joint portion 6a, and is securely held. Further, the curved connecting portion 7b serves as a finger hole when the holding clip 7 is removed.

When the infusion container 1 configured as described above is used, as shown in FIG. 2, when the holding clip 7 is removed, the vial 4 in the outer envelope container 6 can freely move. As shown, the mouth portion of the vial bottle 4 is fitted and connected to the mouth member 5. Since the outer container is transparent, the inside can be seen through, and the operation of joining the vial to the mouth member can be easily performed. After use, as shown in FIG. 4, the outer container 6 is torn from the cut portion 8, the vial 4 inside is taken out, and the glass (vial bottle) and the resin molded product (outer container, bag-shaped container and mouth member, etc.) Can be separated and discarded.

[0015]

[Effect of device]

 According to the infusion container of the present invention, the opening of the outer container made of a flexible material that seals the vial is fusion-bonded to the upper part of the mouth member attached to the bag-shaped container. Since the vial bottle and the mouth material inside the outer container are separated by being held by the holding clip from the outside, the vial bottle does not come into contact with the mouth member unintentionally when not in use. There is no risk that the stopper of the vial will come into contact with the puncture needle placed inside. In addition, since the vial inside the outer container can be freely moved by removing the holding clip during use, the mouth of the vial can be fitted and connected to the mouth member. If it is transparent (including translucent), it can be left in a sealed state while being observed from the outside. After use, the outer container can be ruptured from the cut portion, the vial bottle inside can be taken out, and the glass (vial bottle) and the resin molded product (outer container, bag-shaped container, mouth member, etc.) can be separated and discarded. Furthermore, the opening of the outer container in which the vial bottle is sealed in the mouth member attached by means such as fitting or screwing to the bag-shaped container directly or through the plug body that is previously fused to the bag-shaped container. Since the parts are closely joined and the outer container is held by the holding clip, the structure is extremely simple, the number of parts is small, the assembly is easy, and the cost can be reduced. .

[Submission date] July 13, 1993

[Procedure Amendment 1]

[Document name to be amended] Statement

[Correction target item name] 0007

[Correction method] Change

[Correction content]

The above-mentioned synthetic resin mouth member and the outer container can be adhered and joined to each other by a usual heat fusion method, an ultrasonic adhesion method, a high frequency adhesion method, or the like. It is also possible to use a close-bonding method by tightening in a strip shape. In the case of using an adhesive, it cannot be said to be preferable, because undesired gas or the components of the adhesive enter the outer envelope container. For the aseptic joining of the synthetic resin mouth member and the outer container, both can be treated in a sterile room and then joined in that room, but depending on the method of assembling the parts, another method may be used. But it's okay. The infusion container according to the present invention is not limited to this joining method.

[Procedure Amendment 2]

[Document name to be amended] Statement

[Correction target item name] 0013

[Correction method] Change

[Correction content]

The outer container 6 is formed of a transparent synthetic resin film, and the lower opening portion of the tubular film is brought into close contact with the outer periphery of the upper portion of the mouth member 5 by heat contraction, and the vial container 4 is housed inside and the upper opening portion is opened. Heat seal parts. In this embodiment, the outer periphery of the upper portion of the mouth member 5 is adhered by heat contraction. However, the entire outer periphery of the mouth member is wrapped, and the outer periphery of the lower portion of the mouth member and / or the end face of the lower end thereof is adhered by heat contraction, for example. The method of making it possible can also be preferably adopted. However, the present invention is not limited to the contact position of the outer container with respect to the mouth member. These sealing operations are performed in a sterile room or the like, and the sealed vial bottle 4 is moved upward and the vicinity of the joint portion 6a is clamped by the clamping clip 7. A cut portion 8 for tearing and a locking hole 9 for suspension are provided in the heat seal portion 6b of the outer container 6. The holding clip 7 is made of synthetic resin, and the rear ends of the opposing holding pieces 7a, 7a are connected by a curved connecting portion 7b so as to have a spring property, and a lower portion thereof has a "C" ring shape. The fitting piece 7c is provided, and the fitting piece 7c is fitted to the outer periphery of the upper portion of the mouth member 5, for example, the outer periphery of the above-mentioned close contact joint portion 6a, and is securely held. Further, the curved connecting portion 7b serves as a finger hole when the holding clip 7 is removed.

[Procedure 3]

[Document name to be amended] Statement

[Name of item to be corrected] 0015

[Correction method] Change

[Correction content]

[0015]

[Effect of device]

 According to the infusion container of the present invention, the opening member of the outer container made of a flexible material for sealing the vial is closely joined to the mouth member attached to the bag-shaped container, and the outer container is clamped from the outside. Since the vial and the mouth member in the outer packaging container are separated by being sandwiched by the vial container, the vial bottle does not come into contact with the mouth member unintentionally when not in use and is placed inside the mouth member. There is no risk of the vial cap touching the existing puncture needle. In addition, since the vial inside the outer container can be freely moved by removing the holding clip during use, the mouth of the vial can be fitted and connected to the mouth member. If it is transparent (including translucent), it can be left in a sealed state while being observed from the outside. After use, the outer container can be ruptured from the cut part, the vial bottle inside can be taken out, and the glass (vial bottle) and the resin molded product (outer container, bag-shaped container, mouth member, etc.) can be separated and discarded. Furthermore, the opening of the outer container in which the vial bottle is sealed in the mouth member attached by means such as fitting or screwing to the bag-shaped container directly or through the plug body that is previously fused to the bag-shaped container. Since the parts are closely joined and the outer container is held by the holding clip, the structure is extremely simple, the number of parts is small, the assembly is easy, and the cost can be reduced. .

[Brief description of drawings]

FIG. 1 is a perspective view showing a main part of an infusion container according to the present invention.

FIG. 2 is a perspective view showing a state in which a holding clip is removed.

FIG. 3 is a perspective view showing a connection state between a vial and a mouth member.

FIG. 4 is a perspective view showing a take-out form of the vial bottle after use.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Infusion container 2 Bag-shaped container 4 Vial bottle 5 Port member 6 Outer container 7 Clamping clip 7a Clamping piece 7c Fitting piece 15 Puncture needle

Front page continuation (72) Inventor Motoharu Kaneko 2-37-24 Nakatehara, Kohoku-ku, Yokohama, Kanagawa Prefecture (72) Inventor Kazuyuki Oda 3-9-9 Sakai, Musashino City, Tokyo

Claims (4)

[Scope of utility model registration request] 1. An infusion solution container comprising a synthetic resin bag-shaped container, and a synthetic resin port member having a puncture needle for connecting the vial and the bag-shaped container to the open end of the container. The opening of the flexible outer container containing the vial is tightly joined to seal the vial container, and the outer container is clamped from the outside by a removable clamping clip for preventing contact between the vial and the mouth member. An infusion container characterized by being. 2. The clamping clip is provided with a "C" ring-shaped fitting piece to be fitted to the outer periphery of the mouth member at the lower part of the facing holding piece. Infusion container. 3. The infusion container according to claim 1, wherein the outer envelope container is provided with a cut portion for opening and an infusion container suspension member. 4. The infusion container according to claim 1, wherein the outer envelope container is formed of a transparent synthetic resin film.