JPH0546456Y2 - - Google Patents

Description

[Detailed explanation of the idea]

Field of Application This invention relates to an improvement of a stopper with a rubber stopper for sealing the liquid collection opening of a soft plastic infusion container such as an infusion bottle or an infusion bag, and only the outwardly exposed surface of the rubber stopper is By arranging a heat-resistant ring to compress the material toward the center, manufacturing and assembly are facilitated.
The present invention also relates to a plastic infusion container stopper that ensures sealing during high-pressure steam sterilization, allows easy penetration of a liquid collection needle into the rubber stopper, and prevents liquid leakage after removal. BACKGROUND TECHNOLOGY When the plastic container for infusion according to this invention is used in a hospital, for example, a bottle needle is pierced through the sealed opening, and the container is directly inserted into a human body using the intravenous needle attached to the other end of the infusion set. It is used for intravenous therapy, etc. to supply fluids to patients. A plastic container stopper for infusions is a plastic cap that is airtightly welded to the mouth of the container to seal the container, such as PP, P.
A cap made of E, PVC, EVA, PET, etc., and a rubber plug that is assembled inside the cap or sealed by insert molding, with the top surface exposed to the outside and the other surface facing the inside of the container. It is composed of. During use, a liquid collection needle, bottle needle, etc. is pierced through the rubber stopper, and other drugs are mixed in (mixed injection) through the bottle needle, etc., and the contents of the drug are taken out (infusion). . Among the mechanical properties required for this plug, the following points are important. The mouth of the plastic container must be securely sealed with both strength and airtightness to prevent leakage. Inserting a bottle needle into a rubber stopper is easy and convenient for a woman to do with one hand, and the plastic container can be suspended with the stopper facing down, making it easier to insert an infusion into an infusion set, while the patient turns over in bed, etc. The bottle needle, etc. must be supported by the elasticity of the rubber stopper so that the infusion set will not fall out even if rocking occurs. After the infusion ends, the bottle is in a suspended position (upside down)
When the bottle needle of the infusion set is pulled out, the rubber stopper instantly seals the needle hole with its elasticity, preventing leakage of the contents from the top surface of the rubber stopper. If the sealing performance of the stopper is poor, for example, if the drug solution scatters from such a container at the bedside, it is inconvenient for both the patient and the caregiver.Furthermore, when co-injecting other drugs into the container, use a rubber seal before instillation. Usually, other drugs are added by inserting a needle into a rubber stopper, but when the needle is pulled out after the mixture is injected, the rubber stopper instantly seals the needle hole, allowing foreign matter, bacteria, etc. to escape from inside the container. It is necessary to prevent it from entering. The production of rubber stoppers for infusion containers consists of a plastic cap part, that is, a thermoplastic plastic part, and a rubber stopper (NR, IIR, BR, IR).
There are two methods: molding the caps individually and then assembling them and welding them together, and a method of sealing the rubber stopper inside the cap and injection molding. Furthermore, since the plastic material used for the cap is welded to the plastic container, the same material as the container is usually used. In recent years, there has been a demand for soft bottles and soft bags that can be flexibly deformed, but in order to extract the drug solution without introducing air into the container, the container itself can respond to changes in the amount of liquid during infusion at atmospheric pressure. It is made of soft plastic that is easy to shrink and deform. If a container such as low-pressure PE, PP, or PET that does not soften at high-pressure sterilization temperatures (105°C or higher) is used, it will be hard at room temperature and will not shrink or deform as the volume of liquid changes during infusion. However, if a soft material such as PE, PVC, or EVA is used for the container, it is necessary to use the same material for the cap, but it will soften at the high-pressure sterilization temperature and the holding power of the rubber stopper will decrease. For the above-mentioned purpose, it is desirable that the sealed rubber stopper be compressed within the cap, but this effect cannot be expected if the cap is made of soft plastic. Problems with the prior art For example, the stopper 30 shown in FIG.
169835), the cap body 31 is provided with rubber plugs 32, 3 having an H-shaped cross section as shown in FIG. 3b or c.
3 into contact with the chemical solution and the rubber plugs 32, 3
The end plug 34 is installed so that the component 3 does not elute.
It is fitted into a groove provided in the inner circumferential part of the flange of the cap body 31, and has a shape in which the cap body 31 and the plug part 34, which mainly provide strength, are fitted into each other, so that strength is obtained from both. The cap body 31 and the flanges of the end plug 34 are sealed to the mouth rim 3 of the container mouth 2 by, for example, high frequency, ultrasonic, or heat sealing. If the cap body 31 and the plug portion 34 are made of soft plastics that deform at sterilization temperatures, the above-mentioned effects will not be obtained. A stopper 40 (Japanese Utility Model Publication No. 17469/1983) shown in FIG. 4 is inserted into an inner stopper 42 made of PP that can withstand sterilization temperatures.
3 is pushed in, thermoplastic plastic is injection molded around the outer periphery of this plastic inner stopper 42 to form the cap body 41. The plug body 50 shown in FIG. 5 (Japanese Unexamined Patent Publication No. 63-248657) is made by making the outer periphery of the rubber plug 53 from metal, engineering plastic, ceramic, glass, etc. that does not deform due to heat.
By compressing the rubber plug 53 with caulking members 54 and 55 having an inner diameter smaller than the outer diameter of the rubber plug 53 and assembling the outer cap 51 and the inner cap 52, the rubber plug 53 is compressed.
Although this method aims to improve the resealability of No. 3, its effectiveness is small, the needle resistance increases, and the mass production process is complicated. In each of the conventional configurations described above, the outer periphery of the rubber stopper is compressed to mechanically impart elasticity in order to improve the recovery performance of the rubber stopper in the stopper body when a syringe needle that has been struck is pulled out. However, there were problems such as simply increasing needle prick resistance, not clearly showing resealability effects, and having difficulty in mass production. Purpose of the invention In view of the current situation, this invention eliminates the occurrence of defects during sterilization, protects the piercing position of the rubber plug until use, and significantly improves the recovery performance after piercing the rubber plug. The object of the present invention is to provide a plastic container stopper for infusion having a structure that does not cause an increase in needle pressure. Summary of the idea This idea aims to decisively improve the recovery performance of the rubber stopper and to create a stopper that does not cause an increase in needle pressure.This idea aims to determine which part of the rubber stopper is most effective to compress. As a result of various studies, we found that by compressing only the outwardly exposed surface of the rubber stopper toward the center, we achieved a clear resealing effect with less needle resistance, and completed this idea. This idea is based on a soft plastic that covers at least the outer periphery and holds a press-fitted rubber stopper, and that seals the opening of the soft plastic infusion container by welding the flange that comes into contact with the opening flange. A plastic container stopper for infusions consisting of a covered cap made of rubber, or a plastic container stopper for infusions consisting of an inner cap having the above structure and a covering cap that covers the inner cap and the outer periphery of the rubber stopper. In order to compress the outwardly exposed surface of the rubber plug that is pierced from the outer diameter direction, it has an inner diameter that is 2 to 8% smaller than the outer diameter of the exposed surface, and is made of a heat-resistant plastic that does not soften or deform at high-pressure steam sterilization temperatures. This plastic container stopper for infusion is characterized in that a rubber ring is disposed around the outer periphery of the outwardly exposed surface of the rubber stopper. Preferred configuration of the device This device uses a heat-resistant ring to compress only the outwardly exposed surface of the rubber stopper toward the center.
It exhibits a clear resealing effect with low needle resistance. The restorability of the rubber stopper after the needle is removed is determined by the outer diameter of the top surface of the rubber stopper, which is first perforated when the needle sticks, and which follows the needle all the way when it is pulled out. The most effective method is to compress the area toward the center. Furthermore, if this compression is performed over the entire thickness of the rubber stopper, the rubber stopper will only be deformed and will not be very effective in restoring the rubber. The heat-resistant ring has an inner diameter that is at least 2 to 8% smaller than the outer diameter of the fitting portion of the rubber plug,
The outer diameter and thickness may be appropriately selected depending on the repulsive force of the compressed rubber stopper. The thickness of the heat-resistant ring is 1/6 to 1/2, preferably 1/5 to 1/3, of the thickness of the rubber stopper. In this invention, when using the inner cap material, it is necessary to prevent harmful components from being eluted by contact with the chemical solution.
It is molded from conventionally known plastic, has a flange around the mouth edge that can be pressure welded, and has a peripheral wall on the head that holds a press-fitted rubber stopper. Any structure may be used as long as it has sufficient strength and can serve as the main strength of the stopper together with the covering cap material. It is also a good idea to provide a thin partition wall to prevent the rubber stopper from coming into contact with the drug solution, and the location of the thin wall section provided in the partition wall for the insertion of the liquid sampling needle may vary depending on the type of container and the drug solution to be filled. The shape, number, etc. may be appropriately selected. Preferred members constituting the stopper of this invention are: 1. A smooth circle made of rubber suitable for pharmaceutical use, such as isoprene rubber, butadiene rubber, butyl rubber, and whose exposed upper surface can be compressed with a heat-resistant ring. Soft vulcanized rubber stopper 2 with a circumferential surface or a stepped surface for a heat-resistant ring as in the embodiments Plastics that do not soften and deform at high-pressure steam sterilization temperatures, such as PP, PET, high-density PE, or
A heat-resistant ring 3 made of heat-resistant non-softening plastic and having an inner diameter 2 to 8% smaller than the outer diameter of the fitting part of the rubber stopper. A covered cap made of a plastic material and configured to enclose a rubber plug fitted with a ring in advance in such a manner that only its upper surface is exposed to the outside, a rubber plug formed from an inner cap, and a plastic covered cap; The inner cap can be manufactured by assembly or by injection molding with a rubber stopper inserted, and can be selected as appropriate depending on the conditions such as the shape of the covered cap, the shape of the inner cap, and the production volume. Automation can be achieved. Disclosure Based on the Drawings of the Invention Fig. 1 is a longitudinal sectional view and a top view of a plastic container stopper for infusion according to this invention, and Fig. 2 is a longitudinal sectional view of the stopper showing another configuration according to this invention. . Here, the structure of the stopper will be explained in order of manufacturing steps. The rubber stopper 13 shown in FIG. 1 has a disc shape, has a stepped portion on the outer peripheral edge of the flat upper surface, and has a small groove on the lower surface that fits with the inner cap 12, so that only the exposed surface after assembly is provided. A heat-resistant ring 14 for compressing 2 to 8% toward the center is fitted into the stepped portion. The plug body 10 is composed of a covering cap 11 that encloses the rubber plug 13 so that only the upper surface thereof is exposed to the outside, and an inner cap 12 that fits and encloses the lower surface of the rubber plug 13. Inner cap 1
2 are welded on their respective flange surfaces, and the assembled stopper 10 is placed on the mouth 2 of the plastic container 1, and the flange of the inner cap 12 is applied to the mouth edge 3 by heat, high frequency, ultraviolet radiation, etc. The container can be sealed by pressure welding by a known means such as a sonic method. In addition, during storage, whether or not to provide a diaphragm 15 that separates the rubber stopper 13 and the drug contained in the container until the bottle needle or the like is pierced is determined by
This is provided to adjust the interaction of item 3, and does not affect the highly elastic plug structure that is the object of this invention. The rubber stopper 22 shown in FIG. 2 is disc-shaped, has stepped portions on the outer periphery of the flat upper and lower surfaces, and has a heat-resistant ring 23 for compressing the exposed surface by 2 to 8% toward the center. is fitted into the upper surface stepped portion. Further, the rubber stopper 22 to which the ring 23 has been fitted
PE, by insert molding or assembly method.
The plug body 20 is completed by enclosing and molding it with a covering cap 21 made of soft plastic such as PVC or EVA. EXAMPLE In order to confirm the sealing effect of the plug according to this invention, the plug according to this invention shown in FIG. 1 (Example 1), and the plug having the same structure as in FIG. Comparative Example 1) and a plug (Comparative Example 2) in which the central part of the rubber plug was compressed with a caulking member as shown in FIG. Test method 1 and Table 1 of the test results are tests for measuring the amount of leakage of the contents of the infusion set when the infusion set is removed after the infusion is completed in the case of plastic bottles. The table below shows a test in which several types of soft-backed medicinal solutions were mixed using a syringe needle and stored at a nursing station until used on a patient. Test method 1 500 ml of water was poured into a PE plastic bottle with a capacity of 500 ml, and each stopper was welded to the mouth. after that,
After high-pressure steam sterilization at 110℃ for 30 minutes, a plastic bottle needle (JMS200 type needle, conduction is interrupted) is inserted into the stopper, the bottle is hung upside down, and left for 2 hours.
The bottle needle was removed, and the amount of liquid leaking from the needle hole in the rubber stopper was measured. The leakage amount (number of drops) is one drop =
Evaluation was made using 0.02ml.

[Table] Test method 2 Pour 1000ml of water into a PVC soft bag with a capacity of 1000ml.
ml and welded a stopper to the mouth. After that, 110℃,
After 30 minutes of high-pressure steam sterilization, stick a bottle needle (16G mold needle, conduction cut off) into the stopper, lay the bag on its side and let it stand for 30 minutes, remove the bottle needle, and then put it in the bag. A weight load of 5 kg was placed on the tube, and the amount of liquid leaking from the needle hole of the rubber stopper was measured for 24 hours. The leakage amount (number of drops) was evaluated based on one drop = 0.02ml.

[Table] Effect of the invention From Tables 1 and 2, it can be seen that the plug according to this invention has an excellent effect of restoring needle hole marks. That is, in both test methods, the plug according to this invention showed no leakage of the liquid content and showed results that met the purpose. The stopper of this invention has a structure in which the rubber stopper specifies only the outer diameter of the upper surface where the injection needle enters and compresses it toward the center of the circle, so it is easy to pierce the bottle needle of the infusion set syringe. Additionally, when the needle is removed, the needle hole remains instantly restored and sealed. Furthermore, since the rubber material of the stopper according to this invention is fitted with a heat-resistant ring that does not soften and deform at high-pressure steam sterilization temperatures, no defects occur during sterilization.

[Brief explanation of the drawing]

Figures 1a and 1b are a longitudinal sectional view and a top view of the plastic container stopper for infusion according to this invention,
FIG. 2 is a longitudinal sectional view of a container stopper showing another configuration according to this invention. FIG. 3A is a longitudinal sectional view of a conventional stopper and an infusion container, and FIGS. 3B and 3C are longitudinal sectional views of a rubber stopper. FIG. 4 is an exploded longitudinal sectional view of a conventional stopper and infusion container. Figures 5a and 5b are longitudinal cross-sectional views of a conventional stopper and an infusion container. 1... Plastic container, 2... Mouth part, 3...
... Lip portion, 10 ... Plug body, 11, 21 ... Covering cap, 12 ... Inner cap, 13, 22 ... Rubber stopper, 14, 23 ... Heat-resistant ring.

Claims (1)

[Claims for Utility Model Registration] 1. Holding a rubber stopper which is press-fitted by covering at least the outer periphery, and welding the flange that abuts against the opening flange of a soft plastic infusion container to close the opening. In a plastic infusion container stopper consisting of a sealed soft plastic cover cap, the outwardly exposed surface of the rubber stopper through which the injection needle pierces is compressed from the outer diameter direction, so that the outer diameter of the exposed surface is 2 to 8 mm.
A plastic container for infusions, characterized in that a heat-resistant ring made of plastic having an inner diameter of % smaller and not softening and deforming at high-pressure steam sterilization temperatures is disposed around the outer periphery of the outwardly exposed surface of the rubber stopper. Plug body. 2. A soft plastic inner part that covers at least the outer periphery and holds the press-fitted rubber stopper, and seals the mouth part by welding the flange part that comes into contact with the opening flange part of the soft plastic infusion container. In a plastic container stopper for infusions consisting of a cap, an inner cap, and a covering cap that covers the outer periphery of the rubber stopper, the outwardly exposed surface of the rubber stopper through which the syringe needle pierces is exposed in order to compress it from the outside radial direction. 2~8 from surface outer diameter
A plastic container for infusions, characterized in that a heat-resistant ring made of plastic having an inner diameter of % smaller and not softening and deforming at high-pressure steam sterilization temperatures is disposed around the outer periphery of the outwardly exposed surface of the rubber stopper. Plug body.