JPH06225922A - Container for medical treatment - Google Patents

Abstract

PURPOSE:To prevent a needle from penetrating through a wall of a discharge hole and to improve weldability of the discharge hole to a container even when the needle is not pierced to a rubber plug of the discharge hole in the right angle direction in the container for medical treatment such as a container for infusion. CONSTITUTION:In the discharge hole 20 connected with a container hole part 11, a core part 21 welded with the container hole part 11 is formed of a material being the same or similar resin as that for a container 10 or the inner layer of the container 10 and the overcoat part 22 of the discharge hole 20 positioned above the container hole part 11 is formed of a resin with a higher rigidity than that for the core part 21.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical container, and more particularly to a medical container in which a synthetic resin discharge port is integrally connected to an opening of a synthetic resin container.

[0002]

2. Description of the Related Art Conventionally, in medical containers such as infusion containers, it is necessary to prevent contact of the chemical solution with the outside so as not to be contaminated. The container is used. As the medical container, a soft bag made of a cross-linked ethylene vinyl acetate copolymer, a polyethylene resin, and a copolymer of ethylene and α-olefin is used. With a soft bag, it is easy to discharge the contents of the chemical liquid, and its discharge port can be welded to the container by heat. Due to the necessity of welding, for example, a resin of the same quality as the resin used for the container such as polyethylene resin. Is used as an outlet. However, when using a medical container, especially if the outlet is low in terms of rigidity such as linear polyethylene, insert a needle for taking out the drug solution into the outlet to seal the drug solution outside the container. For example, in the case of an emergency, when the needle is not pierced from the direction perpendicular to the rubber plug of the discharge port, the needle penetrates the wall of the discharge port, the content of the chemical solution is contaminated, the worker is injured, etc. Occurred and there was a problem in safety.

On the other hand, the discharge port is multi-color molded (Japanese Patent Laid-Open No. 62-
233162, Japanese Patent Laid-Open No. 62-254760), in which the outer layer portion of the discharge port is made of the same material as the inner layer of the container at the welded portion of the discharge port and the container, and the inner layer of the discharge port is made of another material. Has been done. However, when the liquid contact portion of the discharge port is molded in two colors using resins having different crystal structures, for example, PE (polyethylene) is used as the inner layer of the container, PE is used as the welded part of the container at the discharge port, and the PE layer is When the inner side is made of PP (polypropylene), it is difficult to completely weld the inner layer (PP layer) of the outlet and the outer layer (PE layer), and the inside and the outside of the container are inserted between the PP layer and the PE layer of the outlet. There is a risk of contact with. In order to prevent this, it is necessary to provide an adhesive layer between the inner layer and the outer layer for three-color molding, but this increases the production cost. In addition, since the inner and outer layers (PP layer, PE layer) come into contact with the liquid at the inner end, it is limited to a highly hygienic resin,
It becomes a high cost factor.

In addition, there is proposed a method (Japanese Patent Laid-Open No. 64-55226) in which an adhesive layer having a heat-welding property is integrally formed on both the discharge port and the container at the heat-welding portion with the container. However, the localized adhesive layer coating has been very cumbersome to manufacture. Therefore, in the present invention, by solving the various problems described above, it is possible to prevent penetration from the wall of the discharge port when the needle is not pierced in the direction perpendicular to the rubber plug of the discharge port and to the container. It is an object of the present invention to provide a material that can satisfy the weldability of the discharge port.

[0005]

Means and Actions for Solving the Problems As a medical container according to the present invention capable of achieving the above object, a discharge port is connected to a mouth of a medical container made of synthetic resin, and the discharge port is partially The container is composed of a core portion welded to the container mouth portion and an outer jacket portion formed on the outside of the core portion in a layered manner above the container mouth portion, and the core portion is the same or homogeneous material as the container or the inner layer of the container. It is characterized in that it is made of resin, and the material of the mantle part is made of resin having higher rigidity than the core part.

According to the present invention having the above-mentioned structure, the core portion of the discharge port made of synthetic resin to be welded to the container mouth is either a container (when the container is a single layer) or an inner layer (when the container is a multilayer). Since the material is made of the same or the same type of resin, it is easy to weld together, and since the outer cover of the discharge port is above the container mouth, it does not come into contact with liquid, and the material is Due to the high rigidity, it is possible to prevent the needle from penetrating the outlet even when the needle is not pierced in the direction perpendicular to the rubber stopper.

That is, according to the present invention, at the outlet of a medical container, for example, when the container or the inner layer of the container is made of polyethylene resin, the portion to be heat-welded at the outlet is provided in order to have a weldability with the medical container. Is made of polyethylene resin or the same type of thermoplastic resin as the synthetic resin used in the container, and the other part of the discharge port (outer part) is penetrated by the needle during needle stick. In order to prevent the above, and to firmly hold the rubber stopper for sealing the opening of the discharge port, by using a rigid resin, the injection needle at the time of needle stick while maintaining heat welding property with the container It prevents the penetration of the wall of the discharge port, and has a high degree of sealing of the container with the rubber stopper, which is a discharge port pursuing the prevention of contamination of the chemical liquid in the container and the safety during use. Description of Manufacturing the Container of the Present Invention As a method of molding the discharge port of the present invention, for example, in the case of two-color molding, in the first stage, a welding part having a heat-welding property with the container is molded, and then the mold is opened. Move the mold while holding the welded part of the discharge port, and clamp the mold on the second stage.
Injection mold the mantle. The welding member is fitted at the time of injection molding of the welding portion by providing a projection on a portion where the outer member is injection-molded so that the welding member can be fitted.
An outlet is formed.

The thus formed discharge port is heat-welded to a medical container, then filled with a chemical solution as in the conventional case, a rubber stopper is inserted, and then another member is welded to the top surface (actually 1-104).
144) or the top surface is heated and curved (Japanese Patent Laid-Open No. 1-1269).
70, actual opening 3-88535) and the like to fix the rubber stopper for use. As another molding method of the discharge port of the present invention, a rubber plug is inserted into a molding machine, the rubber plug and the discharge port of the thermoplastic resin are integrated by insert molding together with the discharge port, and the discharge port of the present invention, It is also possible to fill the medical container with the content drug solution and then heat-bond the outlet to use.

Since the rubber stopper is fixed between the welded portion and the protrusion of the catch portion of the outer jacket and the welding member on the top surface or the heating curved portion, the outer jacket is self-sealing of the rubber stopper and holds the infusion needle. A thermoplastic resin having high dimensional stability during sterilization, high rigidity, and high melting point is desirable in order to improve the property and prevent the rubber plug from falling off. In addition, it is desirable to have high rigidity in the sense of preventing needle penetration during use. For example, in addition to polypropylene, high density polyethylene, a mixture of polyethylene and polypropylene, a mixture of polyethylene and polyethylene terephthalate, a polyethylene and a cyclic olefin copolymer (for example, Mitsui Oil Co., Ltd. It is preferable to use a mixture of chemical products under the trade name "Apel"). In particular, when heat-curing is performed, it is difficult to use heat-curling when the mantle is made of polyethylene-based resin. Therefore, it is desirable to use a polypropylene-based resin having rigidity.

Since the portion to be welded to the container needs to be a synthetic resin which can be heat-welded to the container, when the resin in the portion to be heat-welded to the container is a polyethylene resin, a polyethylene resin or a homogenous thermoplastic resin is used. In the case of resin or polypropylene resin, polypropylene resin or homogeneous thermoplastic resin is desirable. Here, with respect to the portion caught by the outer jacket, a certain degree of rigidity is required for fixing the rubber plug, as in the case of the outer jacket. Further, in order to further have the function of preventing needle stick penetration, it is necessary to increase the wall thickness or increase the rigidity, but it is desirable to increase the rigidity from the viewpoint of manufacturing cost and design. For example, when the inner layer of the container is made of linear polyethylene, the welded portion of the discharge port is rigid and has high density linear polyethylene (density 0.9
It is preferable to use 35 g / cc or more). When possible by combining with a container, a material having a melting point lower than that of the inner layer of the container is used, and the finish of the seal is more beautiful.

Further, by using a polyolefin resin having no eluate in the welded portion which contacts the chemical liquid in the container and using a colored resin in the non-contact portion on the outside thereof, a safe method which does not affect the chemical liquid in the content can be obtained. The product can be identified.

[0012]

DESCRIPTION OF THE PREFERRED EMBODIMENTS Next, the structure of the present invention will be described below with reference to the drawings. Reference numeral 10 denotes a synthetic resin medical container such as an infusion container, and 11 denotes a container mouth. 20 is a discharge port, 21 is a core part of which is partially welded to the container opening 11.
Reference numeral 22 denotes a mantle portion which is formed in layers outside the core portion 21 above the container mouth portion 11. Reference numeral 30 denotes a rubber stopper, and 22a and 22b denote protrusions and bent portions for fixing the rubber stopper 30 in the outer cover portion 22.

Reference numeral 40 denotes a peel seal, and 41 denotes a peeling tongue piece of the peel seal 40. And the core 21
Is made of a resin that is the same or homogeneous as the inner layer when the container 10 is a single layer and the inner layer when the container 10 is a multi-layer, and the outer cover 22 is made of a resin having a higher rigidity than the core 21. Is formed by. Specific examples will be shown below. Example 1 Container 10 ... Linear polyethylene (density 0.930 g / cc, melting point
122 ℃) Core 21 ... Linear polyethylene (density 0.945g / cc, melting point
127 ℃) Outer part 22 ... Colored polypropylene (density 0.910g / c
c, melting point 150 ° C) In this case, in the manufacturing method, the core 21 is heat-welded to the mouth of the container, filled with the content chemical solution, inserted with the rubber stopper, and then the rubber stopper is heated using a bending jig heated to 140 ° C. On the other hand, the upper portion of the mantle portion 22 is pressed and curved, and after forming the top surface of the discharge port, a peel seal is performed to complete it (see FIG. 1). Example 2 Container 10 ... Linear polyethylene (density 0.930 g / cc, melting point
122 ℃) Core 21 ... Linear polyethylene (density 0.945g / cc, melting point
127 ℃) Outer part 22 ... Polyethylene terephthalate (Density 1.34g /
(cc, melting point 255 ° C.) In this case, the rubber plug is insert-molded in the outer cover 22, and the core 21 may be heat-welded to the container opening 11 and then the peel seal 40 may be formed.

In the second embodiment, the structure after manufacturing is the same as that of the first embodiment.
The same can be illustrated as in FIG. Example 3 Container 10 ... Multiple layers with inner layer of linear polyethylene (density 0.9
30 g / cc, melting point 122 ° C) Core 21 ... Linear polyethylene (density 0.945 g / cc, melting point
 127 ℃) Mantle 22 ... Colored polypropylene (density 0.91g / cc,
Melting point 150 ° C.) A fixing member 50 for a rubber plug is colored above the mantle 22.
Polypropylene (Density 0.910 g / cc, melting point 150
(° C), insert the rubber stopper 30 and heat the fixing member 50.
It is melted and heat-welded to the mantle part 22 and a rubber stopper
Hold down 30. Finally peel seal 40
I do.

The structure after the manufacturing is as shown in FIG.

[0016]

According to the present invention having the above-mentioned structure, the core of which the discharge port made of synthetic resin is welded to the mouth of the container is the container (when the container is a single layer) or the inner layer of the container (when the container is a multilayer). )
Since it is formed of the same or the same material as the resin, it is easy to integrally weld to the container mouth, and the outer jacket of the discharge port above the container mouth is made of a material that is more rigid than the core. Since it is expensive, it is possible to prevent the needle from penetrating the wall of the outlet even when the needle is not pierced in the direction perpendicular to the rubber plug.

[Brief description of drawings]

FIG. 1 is a cross-sectional view of a medical container of the present invention.

FIG. 2 is a cross-sectional view of a modified example.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 10 Container 11 Container opening 20 Discharge port 21 Core 22 Outer shell 30 Rubber stopper 40 Peel seal

Claims (1)

[Claims] 1. A discharge port is connected to a mouth of a medical container made of synthetic resin, and the discharge port includes a core part partially welded to the container mouth and a core part above the container mouth. The outer core is made of a resin having the same or similar material as that of the container or the inner layer of the container, and the outer cover is made of a resin having a higher rigidity than the core. A medical container characterized by being formed as follows.