JP3004139B2 - Medical container - Google Patents

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 outlet 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 the contents of a medical solution from coming into contact with the outside so as not to be contaminated. Containers are used. As the medical container, a soft bag made of a crosslinked ethylene-vinyl acetate copolymer, a polyethylene resin, and a copolymer of ethylene and an α-olefin is used. In a soft bag, the contents can be easily drained, and the outlet can be welded by heat to the container.The need for the welding makes it possible to use a resin of the same quality as the resin used in containers such as polyethylene resin. Are used as outlets. However, particularly when the medical container is used, if the outlet is low in rigidity such as linear polyethylene, a needle for taking out the chemical solution is pierced into the outlet at the sealed portion of the outlet, and the medicinal solution is discharged outside the container. For example, in the case of emergency, when the needle is not punctured at right angles to the rubber stopper at the outlet, the needle penetrates the wall of the outlet, contaminating the drug solution, injuring the worker, etc. Occurred and there was a problem in safety.

On the other hand, the discharge port is formed by multi-color molding (Japanese Patent Laid-Open No. 62-1987).
233162, Japanese Patent Application Laid-Open No. 62-254760), the outer layer of the outlet at the welding portion between the outlet and the container is made of the same material as the inner layer of the container, and the inner layer of the outlet is made of another material. Has been made. However, when the liquid contacting portion at the outlet is molded in two colors by using resins having different crystal structures, for example, the inner layer of the container is made of PE (polyethylene), the welded portion of the outlet with the container is made of PE, and the PE layer of the PE layer is formed. When the inside is made of PP (polypropylene), it is difficult to completely weld the inner layer (PP layer) and the outer layer (PE layer) of the outlet, and the inside and the outside of the container pass between the PP layer and the PE layer at the outlet. There is a risk of contact. In order to prevent this, it is necessary to provide an adhesive layer between the inner layer and the outer layer and perform three-color molding, but the production cost increases. Also, since the inner and outer layers (PP layer, PE layer) are in contact with the liquid at the inner end, the resin is limited to highly hygienic resin,
This is a high cost factor.

[0004] In addition, a method has been proposed in which an adhesive layer having heat-welding properties is integrally formed on both a discharge port and a container at a heat-welded portion with the container (Japanese Patent Application Laid-Open No. 64-55226). However, localized adhesive layer coating was very cumbersome to manufacture. Therefore, in the present invention, it is possible to solve the above-mentioned various problems and prevent the penetration of the rubber stopper of the outlet from the wall of the outlet when the needle is not pierced at right angles to the rubber stopper. It is an object of the present invention to provide a material that can satisfy the weldability of an outlet.

[0005]

The medical container according to the present invention which can achieve the above object has a discharge port connected to the mouth of a synthetic resin medical container, and the discharge port is partially formed. A core portion welded to the container mouth portion, and a mantle portion formed in a layer outside the core portion above the container mouth portion, the core portion having the same material or the same material as the inner layer of the container or the container. It is characterized by being formed of resin, and the outer jacket is formed of resin having higher rigidity than the core.

According to the present invention having the above structure, the core of the outlet made of synthetic resin welded to the mouth of the container is connected to the container (when the container is a single layer) or the inner layer of the container (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 jacket of the discharge port is above the container mouth, it does not come in contact with the liquid. Due to the high rigidity, it is possible to prevent the needle from penetrating through the outlet even when the needle is not stabbed in a direction perpendicular to the rubber stopper.

That is, according to the present invention, when the container or the inner layer of the container is made of a polyethylene resin, the outlet of the medical container is heat-welded in order to impart a weldability to the medical container. Is made of a resin of the same quality as the synthetic resin used for the container, such as a polyethylene resin or a thermoplastic resin of the same type, and the other part (outer part) of the outlet is penetrated by the needle when the needle is pierced. The injection needle at the time of needle piercing while maintaining the heat-sealing property with the container by using a rigid resin for the purpose of preventing the occurrence of water and firmly holding the rubber stopper for sealing the opening of the discharge port It has a high degree of hermeticity of the container with a rubber stopper, prevents contamination of the chemical solution inside, and pursues safety during use. Description of Manufacturing of Container of the Present Invention As a method of forming the outlet of the present invention, for example, in the case of two-color forming, a welded portion having heat welding property with the container is formed in the first stage, and then the mold is opened. Then, the mold is moved while holding the welded portion of the discharge port, and the mold is clamped at the second stage.
The jacket is injection molded. The welding member is fitted at the time of injection molding of the welded portion by providing a projection on a portion where the sheath member is injection-molded so that the welding member can be fitted with the jacket member.
An outlet is formed.

After the thus formed discharge port is heat-welded to a medical container, the contents are filled with a chemical solution in the same manner as in the prior art, a rubber stopper is inserted, and then another member is welded to the top surface (actually open flat 1-104).
144) or heating the top surface by heating (Japanese Patent Laid-Open No. 1-1269)
70, actually opened 3-88535). As another method of molding the outlet of the present invention, a rubber stopper is inserted into a molding machine, and the outlet of the thermoplastic resin is integrated with the outlet of the thermoplastic resin by insert molding with the outlet, as the outlet of the present invention, After filling the medical container with the medicinal solution, the outlet can be thermally welded for use.

Here, since the rubber stopper is fixed between the welding part and the projection of the hooked part of the outer part and the welding member or the heating curved part on the top surface, the outer part is self-sealing of the rubber stopper and holds the infusion needle. In order to enhance the property and prevent the rubber stopper from falling off, a thermoplastic resin having high dimensional stability at the time of sterilization, rigidity and high melting point is desirable. It is also desirable to use a material having high rigidity to prevent penetration of the needle 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 It is desirable to use a mixture of the chemical trade name "Apel"). In particular, in the case of performing a heating curve, if a jacket is made of a polyethylene resin, the heating curve is difficult. Therefore, it is preferable to use a rigid polypropylene resin.

Since the portion to be welded to the container needs to be a synthetic resin that can be thermally welded to the container, if the resin at the portion to be thermally welded to the container is a polyethylene resin, the resin is a polyethylene resin or a homogeneous thermoplastic resin. In the case of a resin or a polypropylene-based resin, a polypropylene-based resin or a homogeneous thermoplastic resin is desirable. Here, as for the portion to be 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 provide a function of preventing penetration of a needle, it is necessary to increase the wall thickness or increase the rigidity. However, it is desirable to increase the rigidity in terms of manufacturing cost and design. For example, if the inner layer of the container is linear polyethylene, the welded portion of the outlet is a rigid high-density linear polyethylene (density 0.9).
(35 g / cc or more) is desirable. Also, if possible by combination with the container, use of a material having a lower melting point than the inner layer of the container provides a more beautiful seal finish, so that it should be adopted as appropriate.

In addition, by using a polyolefin resin having no eluted material in the welded portion in contact with the chemical solution in the container and using a colored resin in the non-contact portion on the outside, a safe method that does not affect the chemical solution is used. Products can now be identified.

[0012]

Next, the configuration 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 or the like, and reference numeral 11 denotes a container opening. 20 is an outlet, 21 is a core part of which is welded to the container mouth 11,
Reference numeral 22 denotes a jacket formed in a layer on the outside of the core 21 above the container opening 11. Numeral 30 denotes a rubber plug, and 22a and 22b denote protrusions and bent portions of the mantle 22 for fixing the rubber plug 30.

Reference numeral 40 denotes a peel seal, and 41 denotes a tongue for peeling off the peel seal 40. And the core 21
When the container has a single layer, the container 10 is formed of the same or the same resin as the inner layer when the container 10 has a multilayer structure. It is formed with. Specific examples will be described below. Example 1 Container 10: Linear polyethylene (density 0.930 g / cc, melting point
Core 21: Linear polyethylene (density 0.945g / cc, melting point)
127 ° C) Mantle part 22: colored polypropylene (density 0.910g / c
c, melting point 150 ° C.) In this case, according to the manufacturing method, the core 21 is heat-welded to the opening of the container, and the contents are filled with a chemical solution. After inserting the rubber stopper, the rubber stopper is heated using a bending jig heated to 140 ° C. Then, the upper part of the mantle part 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
Core 21: Linear polyethylene (density 0.945g / cc, melting point)
127 ℃) Jacket 22: polyethylene terephthalate (density 1.34g /
In this case, the rubber stopper is insert-molded in the outer cover 22, and the core seal 21 is heat-welded to the container opening 11, and then the peel seal 40 may be formed.

In the second embodiment, the structure after manufacture is the same as that of the first embodiment.
1 can be illustrated as in FIG. Example 3 Vessel 10: Multi-layer, inner layer of linear polyethylene (density 0.9
Core 21: Linear polyethylene (density 0.945g / cc, melting point)
 127 ° C) Mantle part 22: colored polypropylene (density 0.91 g / cc,
Melting point 150 ° C.) A rubber stopper fixing member 50 is colored above the outer cover 22.
Polypropylene (density 0.910 g / cc, melting point 150
After the rubber stopper 30 is inserted using the
Is melted and thermally welded to the mantle part 22 and a rubber stopper is provided.
I'm holding down 30. Ultimately peel seal 40
I do.

The structure after the manufacture is as shown in FIG.

[0016]

According to the present invention having the above structure, the outlet made of synthetic resin is welded to the container mouth, and the core is made of a container (when the container has a single layer) or an inner layer of the container (when the container has a multi-layer). )
And the material is made of the same or the same type of resin, so it is easy to weld integrally to the container mouth, and the outer jacket of the outlet above the container mouth is made of a material more rigid than the core. Since the needle is high, it is possible to prevent the needle from penetrating the wall of the outlet even when the needle is not stabbed in a direction perpendicular to the rubber stopper.

[Brief description of the drawings]

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

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

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 10 Container 11 Container mouth 20 Outlet 21 Core 22 Outer jacket 30 Rubber stopper 40 Peel seal

──────────────────────────────────────────────────続 き Continued on the front page (58) Field surveyed (Int.Cl. ⁷ , DB name) A61J 1/10

Claims (1)

(57) [Claims] An outlet is connected to a mouth of a medical container made of a synthetic resin, and the outlet is partially connected to a core which is welded to the mouth of the container. The core portion is made of the same or the same material as the container or the inner layer of the container, and the outer jacket portion is made of a resin having a higher rigidity than the core portion. A medical container characterized in that it is formed by: