JPS6149980B2 - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a stopper for an infusion container for containing blood transfusions or infusions such as Ringer's and glucose solutions.

Conventionally, glass bottles are often used as containers for infusions, and the sealing process involves filling the cleaned glass bottle with the liquid, plugging the glass bottle with a sterilized rubber stopper, and then inserting the rubber stopper. It was common to clinch-seal with an aluminum cap, then sterilize the glass bottle, and finally cover it with a plastic cover cap and seal the cap with shrink PVC. However, according to this conventional technology, since the rubber stopper comes into contact with the liquid content, there is a drawback that bleed material from the rubber stopper gets mixed into the liquid content, and the sealing work is troublesome due to the large number of components. Become.

In some cases, plastic bottles are used instead of glass bottles, but in this case as well, the sealing process involves filling the cleaned plastic bottle with the liquid and then heat-sealing the plastic stopper. After sterilization, a rubber stopper is fitted, a plastic cover cap is applied, and the cap is sealed with shrink PVC. However, even with this configuration of the prior art, the rubber stopper, which is the part where the needle is inserted to directly inject the drug into the blood vessel, does not enter the sterilization process, although special cleanliness is required. A major drawback is that the rubber stopper is not clean, so the surface of the rubber stopper must be cleaned with alcohol swab or the like before use. Further, as in the case described above, there are many components, and the sealing process is complicated before and after the sterilization process.

Furthermore, in the former case, there is a drawback that during high-temperature heat sterilization, the contaminated external liquid flows into the container through the aluminum cap and rubber stopper due to the difference in pressure between the inside and outside of the container. In the latter case, the plastic stopper and the rubber stopper are simply fitted together, so during high-temperature and high-pressure sterilization, external liquid may flow into the container through the contact surface, or the shape of the plastic stopper may change. In some cases, external liquid may accumulate between the plastic stopper and the rubber stopper, causing the rubber stopper to corrode. Furthermore, if there are many components, the sealing process becomes complicated, and if they are molded individually, they are not suitable for mass production.

SUMMARY OF THE INVENTION The present invention is intended to solve these drawbacks of the prior art, and aims to completely encapsulate a rubber stopper within a plastic stopper body, provide a pull ring protruding from the top surface of the rubber stopper, and form a score. By doing so, it is an object of the present invention to provide a stopper for an infusion container that is extremely hygienic, has excellent sealing properties, and can easily and reliably expose the needle insertion part.

The present invention will be explained below with reference to the illustrated embodiments. Fig. 1 shows a plastic bottle with a sealed opening and a stopper, and Figs. 2 to 4 show the stopper. The plastic bottle B is a stopper, and both are made of a heat-resistant synthetic resin that can withstand high-temperature heat sterilization. A single stopper B generally consists of three parts: an inner stopper 1, an outer stopper 2, and a rubber stopper 3 sealed between the inner stopper 1 and the outer stopper 2. To explain the structure of the plug B in more detail, the inner plug 1 has a cylindrical side wall 4.
It has an intermediate wall 5 at the center of its inner periphery, and an elliptical thin score 6 is formed on the lower surface of the intermediate wall 5. A rod-shaped protrusion 8 is erected at a suitable position inside the periphery of the thin score 6 on the upper surface of the intermediate wall 5 via a rib 7, and on the upper part of the rod-shaped protrusion 8 is an annular pull ring 9 for holding a finger. It is integrally connected in the lateral direction, that is, across the protrusion 8, so as not to protrude upward from the upper end of the side wall 4. Therefore, by hooking a finger on the pull ring 9 and pulling it up, the intermediate wall 5 can be easily opened along the score 6. The above-mentioned inner plug 1 is injection molded from a composite synthetic resin composition containing polypropylene as the main component and ethylene, a propylene copolymer, and an inorganic material such as calcium carbonate. In such cases, even if the intermediate wall 5 can withstand high-temperature heat sterilization, it is difficult to open the intermediate wall 5 along the score 6 due to its tensile strength. By adding an ethylene or propylene copolymer and an inorganic material such as calcium carbonate, which can improve the properties, both heat resistance and ease of opening are satisfied.

The outer stopper 2, which is completely welded to the outer periphery of the inner stopper 1, is integrally provided with an outward flange 12 that is heat-sealed to the opening flange 11 of the plastic bottle A at the upper end of the cylindrical side wall 10. The center of the bottom part 13 connected to the bottom part 13 is formed into an elliptical shape similar to the peripheral shape of the score 6 as a raised bottom thin part 14. This outer plug 2 is the inner plug 1.
It is not necessary to use a synthetic resin composition consisting of polypropylene as the main component and addition of ethylene, propylene copolymer, and inorganic materials such as calcium carbonate. It is sufficient to perform injection molding using a single synthetic resin composition such as rich polypropylene.

The rubber plug 3 has a space 15 formed by the lower part of the side wall 4 of the inner plug 1, the intermediate wall 5, and the thin wall portion 14 of the outer plug 2.
It is completely enclosed inside and hermetically sealed from the outside.

FIG. 5 shows a two-stage continuous injection molding machine for manufacturing the infusion container stopper according to the present invention, where C is the primary mold for forming the inner stopper 1, and D is for forming the outer stopper 2. This is the secondary mold. 16 is a fixed mold of the primary mold C, 17 is a movable mold, 18 is a fixed mold of the secondary mold D, and 17' is a movable mold. Fixed molds 16 and 18 are both fixed platen 2
0, the movable molds 17, 17' are attached to a rotary plate 21 and are rotatable. 22 is a movable plate that rotatably holds the rotating plate 21 and slides each movable mold 17, 17' in the axial direction; 23 is a mold clamping ram connected to the movable plate 22;
24 is a screw extrusion member that extrudes the molten material from a nozzle into the primary mold C, and 25 is a secondary mold D.
This is a screw extrusion member for.

6 to 11 show the manufacturing process of an infusion container stopper molded by the injection molding machine configured as described above, and in FIG. 6, the composite molten material is injected from the screw extrusion member 24. When the inner plug 1 is molded in the primary mold C, the seventh
As shown in the figure, the movable mold 17 of the primary mold C is moved in the axial direction by a movable platen 22. Since the inner plug 1 is held attached to the movable mold 17 during this mold release, the movable mold 17 holding the inner plug 1 is rotated by a predetermined angle by the rotary plate 21. Next, as shown in FIG. 8, a preformed rubber stopper 3 for needle puncture is tightly fitted into the space 15 formed by the inner periphery of the side wall 4 and intermediate wall 5 of the inner stopper 1. Press fit. In this case, as shown in Figure 9, a three-stage continuous injection molding machine is used,
If the movable mold 17 and the fixed mold 26 for molding rubber plugs are clamped together and then molten rubber is extruded, the rubber plug 3 can be continuously injection molded into the bottom space 15 of the inner plug 1. products can be mass-produced.

When the rubber stopper 3 has been fitted, the movable mold 17 of the primary mold C is inserted into the inner stopper 1, as shown in FIG.
The rubber stopper 3 is further rotated while being held, and when it reaches the secondary mold position D, it becomes the secondary movable mold 17', and the clamping ram 23 connects it to the fixed mold 18. After tightening, the outer plug 2 is injection molded by injecting a molten synthetic resin material such as polypropylene into the mold from the screw extrusion member 25. In this way, the side walls 4 and 10 of the inner stopper 1 and the outer stopper 2 are completely welded to improve airtightness, and the rubber stopper 3
The inner stopper 1 is completely airtightly isolated from the outside by the side wall 4 and intermediate wall 5 of the inner stopper 1, and the thin wall portion 14 of the outer stopper 2.

As described above, the plug body B, which is formed by integrally molding the three components of the inner plug 1, the outer plug 2, and the rubber plug 3 sealed therein, is gas sterilized as a single component in advance, and the built-in rubber column 3 is also removed. Sterilize. After filling the cleaned plastic bottle A with the contents,
Insert the stopper B into the opening of the bottle and heat seal between the flange part 12 of the stopper B and the opening flange 11 of the plastic bottle, and completely seal the stopper B into the plastic bottle A as shown in Fig. 1. Once the seal is completed, all work is completed with just the next step of sterilization.

As described above, the infusion container stopper according to the present invention has the following features:
Since the rubber stopper is completely enclosed within the plastic stopper and isolated from the outside, there is no need to sterilize the needle insertion part of the rubber stopper with alcohol cotton etc. during use, and there is no need to sterilize the needle insertion part of the rubber stopper, and there is no need to sterilize the needle insertion part of the rubber stopper, and there is no need to sterilize the needle insertion part of the rubber stopper when using it. There are some advantages. In addition, when the inner stopper with the pull ring and score provided on the middle wall of the top surface of the rubber stopper is made of a composite synthetic resin made of polypropylene as a base material, ethylene, a propylene copolymer, and an inorganic material such as calcium carbonate are added. It is about
It has heat resistance that can withstand the sterilization temperature of infusions of around 120℃, and it can be opened easily along the score to easily expose the needle insertion part of the rubber stopper, making the opening operation easy and reliable. There are also advantages. Furthermore, since the plastic bottle and the stopper, as well as the inner and outer stoppers of the stopper, are completely welded together, the sealing performance is further improved, which also has the advantage of preventing external fluids from entering during sterilization and leaking during storage. . Furthermore, the pull ring that protrudes from the top of the rubber stopper is inserted into the inside of the stopper, which not only makes it convenient to handle during transportation and storage, but also prevents carelessness before use. There are also advantages such as the pull ring does not fall over and the rubber stopper is not exposed to the outside.

[Brief explanation of the drawing]

The drawings show one embodiment of the present invention, and FIG. 1 is a vertical sectional view showing a plastic bottle with its opening sealed and the stopper, FIG. 2 is a central vertical sectional view showing the stopper, and FIG. 3 is a longitudinal sectional view showing the stopper. is the same plan view, Figure 4 is the same bottom view, and Figure 5 is the same bottom view.
The figure is a vertical cross-sectional view showing a two-stage injection molding machine, Figure 6 is a vertical cross-sectional view of the main part showing the clamped primary mold, and Figure 7 is the vertical cross-sectional view of the main part showing the released primary mold. 8 and 9 are longitudinal cross-sectional views of the main parts showing the fitting of the rubber plug, Fig. 10 is a longitudinal cross-sectional view of the main parts showing the clamped secondary mold, and Fig. 11 is the plug being knocked out. FIG. Explanation of symbols, A...Plastic bottle, B...
...Plug body, C...Primary side mold, D...Secondary side mold,
1...Inner stopper, 2...Outer stopper, 3...Rubber stopper, 4
...Side wall, 5...Middle wall, 6...Score, 7...
...Rib, 8...Protrusion, 9...Pull ring, 10...
...Side wall, 11... Flange part, 12... Flange part, 1
3...Bottom part, 14...Thin wall part, 15...Space, 1
6...Primary side fixed mold, 17...Primary side moving mold, 17'...Secondary side moving mold, 18...Secondary side fixed mold, 20...Fixed plate, 21...Rotating plate ,2
2... Movable platen, 23... Mold clamping ram, 24... Primary side screw extrusion member, 25... Secondary side screw extrusion member, 26... Fixed mold.

Claims (1)

[Scope of Claims] 1. A stopper consisting of an inner stopper and an outer stopper that is fitted into the opening of a plastic bottle, wherein the outer stopper is fused and bonded to the entire outer periphery of the inner stopper, and a rubber stopper is sealed therebetween. In addition, an annular score that is easy to open is engraved on the inner surface of the intermediate wall of the inner stopper, and a support section is erected in the needle insertion section that is the outer surface of the intermediate wall and surrounded by the score, and a support section is provided at the upper end of the annular score. The inner plug is made of a composite synthetic resin made of polypropylene, ethylene, propylene copolymer, and inorganic materials such as calcium carbonate. A stopper for an infusion container featuring: