JP2000107256A - Drug-mixing transfusion bag - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medicine-mixing transfusion bag which contributes the simplification of an assembly stage and is excellent in hygienic cummunicable diseases controllability, housing property volume reducing property and easy disposability. SOLUTION: This transfusion bag consists of an upper mouth member 9 which is closed at its upper end face by a cover film A10, a lower mouth member 2 which is integrated with a communicating jig 8 having a pointed end and having an aperture 4 at its base part, is closed at its lower part and is commonly used as a take-out port for a medicine for drip, a flexible container 1 for the medicine for dissolution or dilution which is hermetically closed by both mouth members of the mouth member 9 and the mouth member 2 and a container 14 for another medicine to be dissolved or diluted by the medicine for dissolution or dilution which is closed by a cover film B11. The drug-mixing transfusion bag is formed by joining the cover film face of the upper mouth member of the flexible container 1 and the cover film face of the bag 14 for the other medicine.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a drug-mixed infusion bag used for infusion or the like. More specifically, a drug for dissolving or diluting (in the present invention, referred to as "liquid drug") and another drug (in the present invention, used by mixing or dissolving in a liquid drug) The other drug is referred to as “another drug.”) Is sealed and stored in a sealed state. During transportation and storage, these drugs are kept separated, and these can be easily operated when used as an infusion infusion container. The present invention relates to a drug-mixed infusion bag capable of easily dissolving or mixing both drugs.

[0002]

2. Description of the Related Art In the medical field, intravenous injection is widely used, and some infusions used for intravenous infusion may be prepared by mixing two or more drugs immediately before use. For example, when instilling a powdered drug or a lyophilized drug in a container such as a vial, these are dissolved in a liquid drug to prepare an infusion solution, which is used for instillation injection. Since the mixing operation is performed in an environment such as a consultation room or a sick room, there is a concern that foreign materials may be mixed in or foreign bacteria may enter.

[0003] For the purpose of avoiding such danger, various drug-mixed infusion bags having sanitary quarantine property have been developed. In these drug-mixed infusion bags, a vial drug container and a flexible liquid drug container are sealed in a system protected from the outside air. It breaks the stop, makes it communicate and mixes the two drugs. Such an infusion container is disclosed in JP-A-5-123377,
It has been proposed in JP-A-5-192377 and JP-A-7-255820.

[0004] However, although the risk of invasion of various bacteria has been avoided in these drug-mixed infusion bags, these drug-mixed infusion bags use a conventional vial container, so the number of parts is increased, and the container assembly is increased. There are problems that the process is complicated, the storage amount in box packing or the like due to bulkiness is small, and that the infusion bag body must be disassembled at the time of disposal and separated into rubber, plastic, glass, and the like.

[0005]

DISCLOSURE OF THE INVENTION The present invention has been made in view of the above problems, and can simplify an assembling process and is excellent in sanitary quarantine, storage (volume reduction) and easy disposal. It is an object of the present invention to provide a drug mixture infusion bag.

[0006]

Means for Solving the Problems The present invention provides [1]
a. An upper mouth member having an upper end face closed with a cover film A; b. A lower end member having a pointed end and integrated with a communication jig having an opening at the base, and a lower end member also serving as an outlet for an intravenous drip agent having a closed lower portion; A flexible container for the dissolving or diluting agent sealed by the two-sided member, and for other agents dissolved or diluted by the dissolving or diluting agent closed by the cover film B. Container, consisting of
A drug-mixed infusion bag, wherein the cover film surface of the upper mouth member of the flexible container and the cover film surface of the container for other drugs are joined, and [2] a cover film B at the tip The above object has been achieved by developing a drug-mixed infusion bag according to the above [1], which is a container for another drug sealed with a closed mouth member.

[0007]

DESCRIPTION OF THE PREFERRED EMBODIMENTS The contents of the present invention will be described below in detail with reference to the drawings. Liquid drugs include physiological saline,
Examples include glucose solutions, distilled water for injection, and various other electrolyte-containing solutions. Other drugs include powdered drugs, lyophilized drugs, and liquid drugs used for infusion and the like. In FIG. 1, a flexible container 1 is a flexible container for accommodating a liquid drug, and is made of a material having transparency for confirming the contents and heat resistance for sterilizing the retort. Preferred materials include a single polyolefin film, a laminated film of two or more polyolefins, a laminated film of a polyolefin and another synthetic resin, and the like. The method for producing the flexible container 1 is not particularly limited. For example, it is advantageous to cut a tubular film obtained by general inflation molding in plastic molding and seal the upper and lower portions thereof before use.

The bottom of the flexible container 1 has a pointed end 5 for breaking the cover film, which is mainly composed of polyolefin, the base has an opening 4 in the flexible container, and the lower portion has a closed portion. The lower port member 2 for filling and taking out, which is closed by a rubber stopper 3 or the like, is adhered to the sealing portion 6 of the tubular film 1. In FIG. 1, the tip 5 at the upper end of the communication jig 8 of the lower opening member 2 is sharp and has an advantageous shape for breaking the cover film. Although the communication jig 8 is shown in FIG. 1 as a hollow cylindrical body,
The communication jig 8 only breaks the cover film,
Any shape, such as a needle, pointed bar, or plate, may be used as long as it can break the cover film. The distal end 5 of the communication jig 8 is inserted and supported in a hollow portion of the mouth member 9 in order to surely penetrate the cover film. This mouth member 2 is preferably formed integrally.

The opening 4 at the base of the lower mouth member 2 allows the flexible container 1 to communicate with the closing portion 3 such as a rubber stopper serving as an outlet for taking out a medicine when the lower mouth member is drip-injected. The medicine prepared in the flexible container 1 is provided so as to be taken out of the closing part 3 through the opening 4.
It is advantageous in terms of cost and performance to attach the mouth member 2 to the flexible container 1 by heat sealing. The upper peripheral portion 7 of the flexible container 1 is also bonded by heat sealing. In this case, it is preferable that the upper opening member 9 whose upper end face is closed by the cover film A10 is also bonded to the peripheral portion 7 at the same time. The filling of the flexible container 1 does not need to be limited, but is closed by the upper port member 9, and after the liquid medicine is filled from the port member A2, the closed lower port member 2 is closed.
May be inserted and heat-sealed, or when the lower opening member is heat-sealed in advance, it may be sealed with a rubber stopper 3.

The container 14 for storing another drug is a flexible container and is made of a material having a barrier property against oxygen and water vapor in order to prevent deterioration of the drug. Specifically, a laminate material having a polyolefin layer on the innermost side and a barrier layer disposed thereon is used. If necessary, a protective layer such as polyolefin may be provided on the barrier layer. Preferred materials for the barrier layer include ethylene-vinyl alcohol copolymer, polyamide, polyvinylidene chloride, polyester, aluminum foil or a resin film on which silicon oxide, aluminum oxide or aluminum is deposited, and the properties of other chemicals. These barrier materials are selected or used in combination according to the conditions.

In order to manufacture the container 14 for other chemicals, the bottom surface of a resin film container obtained by general multilayer inflation molding, multilayer T-die molding, laminate molding, etc. used in plastic film molding processing. A mouth member 12 made of polyolefin as a main material and molded by injection molding or the like is adhered to the periphery thereof by a heat seal 13 to form a bag-shaped container.
Alternatively, as shown in FIG. 1, the lower surface of the container 14 may be connected so that the opening of the mouth member 12 whose front end is closed by the cover film 11 passes through the container. in this case,
If necessary, a hole 15 or the like for hanging the gantry can be provided in the peripheral heat seal portion 13 at the time of infusion.

Alternatively, as shown in FIG. 2, the lower surface of the container 14 may be directly closed by the cover film 11. Mouth member 1
When the area of the opening in the container not using the container 2 is large, a plate material having an opening corresponding to the size of the top of the upper opening member 9 of the flexible container 1 is adhered, and the surface thereof is covered with the cover film 1.
It is also possible to close with 1. A string 16 for suspending the gantry at the time of drip injection may be provided on the upper part of the container 14. Examples of such a container 14 include a cup-shaped container formed by using a laminated sheet with a thick blank or vacuum forming, or a container formed by a multilayer blow molding. This container 14
After filling another drug from the mouth member 12 or the container opening, the cover film 11 made of polyolefin as a main material is heat-sealed at the end face of the mouth member 12 or the container opening.

As described above, the flexible container 1 and the container 14 for other medicines can be handled independently since they are sealed by the cover film. Appropriate sterilization conditions can be selected. That is, the flexible container 1 containing a liquid drug is subjected to retort sterilization, which is a high-temperature heat sterilization, while the flexible container 14 containing another drug is subjected to radiation sterilization when there is a risk of deterioration due to heating. After sterilization by
In an aseptic room or the like, the upper port member 9 and the port member 12 of the container for other drugs are covered with cover films 10 and 11.
May be integrated by welding and connecting them. When the mouth member 12 is not provided, the container or plate supporting the cover film 11 and the upper mouth member 9 may be welded. Examples of the welding method include butt welding, hot plate welding, impulse welding, high-frequency welding, and ultrasonic welding, and high-frequency welding is particularly preferable from the viewpoint of productivity.

A drug-mixed infusion container filled with a drug or the like
In order to ensure the safety of the sealed portion during storage and transportation, it is sufficient that the space between the mouth member 2 and the mouth member 9 is protected by a cardboard or the like, so that packing, transportation, and storage can be performed safely. Details of the method of communication between the flexible container 1 and the container 14 for other drugs are shown in FIG. After removing the protective material such as cardboard, the lower mouth member 2 and the upper mouth member 9 of the flexible container 1 are grasped and compressed in the vertical direction. Since the flexible container 1 is freely deformable, the distal end 5 of the communication jig 8 guided by the upper opening member 9 breaks through the cover films 10 and 11, thereby breaking the flexible container for the liquid drug. 1 and the flexible container 14 communicate with each other, and both drugs are mixed. In some cases, it is possible to crush the flexible container 1 and the flexible container 14 alternately to achieve more uniform mixing of the medicines. The prepared drug that has been sufficiently mixed or dissolved is passed through a closing portion (rubber stopper) 3 that closes the mouth member 2 through a hollow needle or the like, and is used for infusion injection or the like.

[0015]

The composite infusion container of the present invention has a small number of parts, is easy to manufacture, has a structure with good productivity, and ensures that each drug is used until it is used even after filling the drug. In use, mixing can be performed with a simple operation while maintaining a sterile state. Furthermore, it is a plastic mixed infusion container that is entirely plastic and easy to dispose, has hygienic epidemiological properties that can be mixed in a sealed drug mixed infusion bag, and has excellent storage properties before use and disposability after use.

[Brief description of the drawings]

FIG. 1 is an example of a front sectional view of a drug-mixed infusion bag of the present invention.

FIG. 2 is another example of a front sectional view of the drug-mixed infusion bag of the present invention.

FIG. 3 is a diagram showing a method of communicating containers according to the present invention.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Flexible container 2 Lower mouth member 3 Closed part (rubber stopper) 4 Opening 5 End part of communication jig 6 Heat seal part 7 Heat seal part 8 Communication jig 9 Upper mouth member 10 Cover film 11 Cover film 12 mouth Member 13 Heat seal part 14 Container for other medicine 15 Hanging hole 16 Hanging string

Continued on the front page (72) Inventor Yohei Kageyama 3-2-2 Chidori-cho, Kawasaki-ku, Kawasaki-ku, Kawasaki-city, Kanagawa Prefecture (72) Inventor Akihiko Sakata 3-chome Chidori-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa-ken 2 Showa Denko KK Research Institute Kawasaki Laboratory F-term (reference) 3E064 AA01 BA24 BB03 EA04 EA30 FA04 HR02 HS03 HS04 HU10

Claims (2)

[Claims] 1. A method comprising: a. An upper mouth member having an upper end face closed with a cover film A; b. Dissolution sealed by a two-port member integrated with a communication jig having a pointed end and having an opening at a base, and a lower port member also serving as a discharge port for a drip infusion agent, the lower portion of which is closed. A flexible container for a drug for dissolving or diluting, and a container for another drug dissolving or diluting with the dissolving or diluting drug, which is closed by a cover film B. A drug mixed infusion bag, wherein a cover film surface of an upper mouth member of a container and a cover film surface of a container for another drug are joined. 2. The medicine-mixed infusion bag according to claim 1, wherein the container is a container for another medicine which is hermetically sealed by a mouth member closed by a cover film B.