JPH11169431A - Medical cap - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medical cap which may be produced by a simple production stage and preventing the inclusion of rubber or the like into medicines. SOLUTION: This cap 1 is a medical plugging body formed by inserting a rubber plugging body 2 into a casing 3. This casing 3 comprises a thermoplastic elastomer. A thin film part 31 which is the component of the casing 3 constitutes a part of the plugging body. The JIS A hardness of the thermoplastic elastomer is preferably >=45 to <=95 deg..

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

The present invention relates to a cap for a medical infusion container. More specifically, the present invention relates to a medical cap that can be easily manufactured and that can prevent rubber and a rubber compound from dissolving into chemicals.

[0002]

2. Description of the Related Art Conventionally, a medical cap using a rubber stopper has a problem that no matter how the rubber and the rubber compound are improved, the rubber and the rubber compound are separated from the surface of the vulcanized rubber as an eluted substance, and the fine particles are used as a chemical. And it becomes a harmful substance.

[0003] In order to prevent such contamination, there is widely disclosed a technique for preventing foreign matter from entering the rubber surface by using a laminated rubber stopper in which a rubber stopper is wrapped with polypropylene, polyethylene, fluororesin, or the like. Have been.

In addition, a technique is also known, which focuses on the elasticity of a thermoplastic elastomer, and uses a rubber stopper covered with a thermoplastic elastomer as a stopper of a medical cap.

[0005]

However, such a medical cap using a rubber stopper coated with a resin or the like requires a separate step of laminating the rubber stopper itself as a manufacturing process, and requires many steps. Met.

That is, first, a rubber stopper is laminated using a resin or the like, and the laminated rubber stopper is inserted into an outer frame of a casing, and then the inner frame is injection-molded, or necessary parts such as a rubber stopper and a casing are provided. Usually, they are prepared and manufactured by a method of assembling them.

[0007] Such a problem in the manufacturing process affects the yield. That is, the yield as a whole has been low in consideration of the occurrence of defective products in each process. Therefore, simplification of the manufacturing process of a medical cap capable of preventing rubber and a rubber compound from dissolving into a drug has been desired.

The present invention has been made in view of the above, and has as its object to provide a medical cap that can be manufactured by a simple manufacturing process and that can prevent contamination of chemicals such as fine particles. is there.

As a result of diligent study of the above problem, the present inventor has adopted a structure in which a rubber plug not laminated with resin is provided in a casing and the casing is made of a thermoplastic elastomer. As a result, knowledge that can solve the above problem was obtained, and the present invention was completed. The present invention is a medical cap in which a rubber stopper is provided in a casing, wherein the casing is made of a thermoplastic elastomer.

FIG. 1 is a schematic sectional view of the medical cap of the present invention. In the figure, 1 is a medical cap of the present invention, 2 is a rubber stopper, and 3 is a casing. In the present invention, it is necessary to manufacture the casing 3 using a thermoplastic elastomer. In the medical cap of the present invention, the rubber stopper 2 is covered with a casing, and the thin film portion 31 and the rubber stopper 2 as constituent elements of the casing 3 have a function as a plug for piercing the cap with a needle. Accordingly, the chemical does not come into direct contact with the rubber stopper 2 and the rubber and the rubber compound do not mix with the chemical. Further, only the rubber stopper and the thermoplastic elastomer are used for such a cap, and the rubber stopper 2 achieves a sufficient effect of the originally required performance of the holding force on the needle and the prevention of water leakage after the needle is removed. It is possible. Furthermore, the structure is extremely simple, and the manufacturing method can be extremely easily manufactured by insert molding as described later.

As a method of manufacturing a medical cap according to the present invention, it is preferable to insert a rubber stopper and manufacture it by injection molding. Specifically, in a state where a rubber stopper is inserted into an injection mold, a thermoplastic elastomer, which is a material of a casing, is injection-molded to be manufactured integrally with the thin film portion 31. By adopting such a manufacturing process, since the heated thermoplastic elastomer comes into contact with the rubber stopper surface, the bonding surface a of the rubber stopper and the thermoplastic elastomer
Are fused and integrated in a pseudo manner, so that the generation of fine particles can be suppressed and the aseptic state can be ensured. In addition, since such a manufacturing process does not require laminating a rubber stopper as in the related art and can be manufactured by only one injection, the number of processes can be reduced, and the overall yield can be improved.

The inventor of the present invention has conducted intensive studies on the type of thermoplastic elastomer used for the casing, and has found that the hardness is preferably from 40 ° to 95 °, particularly from 60 ° to 95 ° in JIS A hardness. Was obtained. The hardness of the thermoplastic elastomer affects the strength of the side wall portion 32 and the thin film portion 31 of the casing. That is, if the hardness is too high, the needle becomes difficult to pass through the thin film portion 31 and the needle stick resistance increases. On the other hand, if the hardness is too low, the cap side wall portion 32 is easily deformed and it becomes difficult to hold the rubber plug 2. . The present inventor has intensively studied the JIS A hardness of the thermoplastic elastomer from such a viewpoint,
It has been found that a range of 5 ° or more and 95 ° or less is preferable.

[0013]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention provides a medical cap having a rubber stopper provided inside a casing, wherein the casing is made of a thermoplastic elastomer. It is assumed that.

The medical cap of the present invention has a structure shown in FIG. 2 as an example. In FIG. 2, the rubber stopper 2 has a structure provided inside a casing 3 made of a thermoplastic elastomer. According to the present invention, the rubber stopper 2 is provided on the casing 1.
There is no direct contact with the chemical by the thin film 31 which is a part, and no rubber or rubber compound is mixed and eluted in the chemical. Further, as the rubber stopper used in the present invention, natural rubber, isoprene rubber, butadiene rubber, styrene-butadiene rubber, isoprene-isobutylene rubber, and the like, which are conventionally most commonly used, can be used. As with the conventional medical cap, it has excellent needle removal strength. The thickness of the rubber stopper according to the present invention is 0.3 to 4 mm, preferably 0.5 to 4 mm.
It is preferably about 1.5 mm.

The thin film portion 31, which is a part of the casing 3, is provided to prevent the rubber stopper 2 from coming into direct contact with the chemical. Therefore, the shape, thickness, etc. are not limited as long as they play the role. However, it is preferable that the thickness of the thin film portion is thin in consideration of the fact that the needle needs to penetrate the thin film portion 31 and come into contact with the medicine at the time of needle sticking. Specifically, a thickness of 0.3 to 4 mm, preferably 0.5 to 1.5 mm, is preferable in terms of strength and convenience of use.

The side wall 32, which is a part of the casing 3, needs to have a strength necessary for holding the rubber stopper. In order to realize this strength, it is preferable to control by adjusting the JIS A hardness of the thermoplastic elastomer. Specifically, its hardness is 4
If the angle is 5 ° or more, the strength is sufficient. However, considering the convenience of use of the thin film portion 31 such as needle stick resistance, its hardness is preferably 95 ° or less. A more preferable range is 60 ° or more and 95 ° or less.

In this embodiment, the casing 3 has a container bonding portion 33 as a part thereof. Container bonding part 3
Numeral 3 is provided for joining the container body and the medical cap. The shape of the container bonding portion is not limited to the shape shown in FIG. 2, and the shape is not particularly limited as long as the bonding with the container can be ensured.

The thermoplastic elastomer used in the casing of the present invention is not particularly limited in its kind. For example, hydrogenated polystyrene-based elastomers, polyvinyl chloride-based elastomers, polyolefin-based elastomers, polyurethane-based elastomers, polyester-based elastomers, and polyamide-based elastomers can be exemplified. In particular, Aron Kasei's thermoplastic elastomer, trade name "AR-860C", Aron Kasei's thermoplastic elastomer, trade name "AR-697C", Mitsubishi Chemical's thermoplastic elastomer, trade name "Lavalon T"
-331C "can be used optimally.

In the medical cap of the present invention, it is preferable that the thin film portion 32 and the casing are integrally manufactured by insert molding, for example, as shown in FIG. First, (a) lower mold 4
(1) Insert the rubber stopper (2) into the lower mold (4).
1 can be manufactured by injecting a thermoplastic elastomer into such a cavity and removing the medical cap 1 from the mold (c). Although FIG. 3 shows the manufacture of the medical cap having the structure of FIG. 2 according to the present embodiment, it goes without saying that a medical cap of another shape can be manufactured by changing the shape of the cavity. Not even.

In the medical cap of the present invention manufactured by such insert molding, rubber and a thermoplastic elastomer are bonded at the interface a between the rubber stopper 2 and the casing 3. Further, since the surface of the rubber stopper is filled with the thermoplastic elastomer which has been heated and melted, there is an advantage that an aseptic state can be ensured.

The medical cap of the present invention can be used by being joined to a container body as shown in FIG. FIG. 4 is a schematic view showing an example of a usage mode of the medical cap of the present invention. In the figure, reference numeral 5 denotes a container main body, and reference numeral 51 denotes an adhesive portion of the container. The method for bonding the medical cap and the container of the present invention is preferably heat sealing. After filling the container body with a chemical, the container bonding portion 33 of the casing and the bonding portion 51 of the container body are fused and bonded. I do. Further, a lid with a pull top may be provided on the upper part of the cap 1.

The present invention is a medical cap in which a rubber stopper is provided in a casing, wherein the casing is made of a thermoplastic elastomer. Since it is simple and the rubber does not come into direct contact with the chemical, the rubber and the rubber compound do not elute into the chemical.

[0023]

EXAMPLE A medical cap having the structure shown in FIGS. 2 and 5 was manufactured by the insert molding method shown in FIG. 3 using a rubber stopper containing butadiene rubber as a main component having the following composition. The difference between the two is whether or not it has a thin film portion, and the material of the casing and the structure of the rubber stopper differ in each embodiment. The injection temperature and pressure were determined based on the specifications of commercially available thermoplastic elastomers and resins. The used thermoplastic elastomers are as follows. Elastomer 1 ·· Aron Kasei Co., thermoplastic elastomer, trade name “AR-860C” hardness 60 ° Elastomer 2 ·· Aron Kasei Co., thermoplastic elastomer, trade name “AR-697C” hardness 95 ° Elastomer 3 ··· Mitsubishi Chemical Co., Ltd., thermoplastic elastomer, trade name “Lavalon SR-04” hardness 45 °

(Example 1) A rubber plug having a thickness of 4 mm and a diameter of 2 cm, which has not been laminated, is inserted into a lower mold, and the upper mold is assembled thereon so as to be compatible with the lower mold. The medical cap of Example 1 having a thin-film portion having a thickness of 1 mm having the structure shown in FIG. 2 was obtained by injection molding the elastomer 1 therein.

(Example 2) A rubber plug having a thickness of 4 mm and a diameter of 2 cm, which has not been laminated, is inserted into a lower mold, and the upper mold is combined with the lower mold so as to be compatible with the lower mold. The medical cap of Example 2 having a thin film portion having a thickness of 1 mm having the structure shown in FIG. 2 was obtained by injection molding the elastomer 2 therein.

(Example 3) A rubber plug having a thickness of 4 mm and a diameter of 2 cm, which has not been laminated, is inserted into a lower mold, and the upper mold is combined with the lower mold so as to be compatible with the lower mold. The medical cap of Example 3 having a thin film portion having a thickness of 1 mm having the structure of FIG. 2 was obtained by injection molding the elastomer 3 therein.

Comparative Example 1 A laminated rubber stopper obtained by laminating a rubber stopper having a thickness of 4 mm and a diameter of 2 cm with a polypropylene sheet was used as a stopper, and the stopper was inserted into a casing (made of polypropylene) to form a thin film portion. A medical cap of Comparative Example 1 having no structure shown in FIG. 5 was obtained.

(Comparative Example 2) Comparative Example 2 of the structure of FIG. 5 having no thin film portion by insert molding a polypropylene resin as a raw material of a casing using a rubber stopper having a thickness of 4 mm and a diameter of 2 cm and not being laminated. A medical cap was obtained.

(Particle Test) After injecting 100 ml of water into the infusion container equipped with the medical cap of each Example and Comparative Example, a needle (Plastic needle made by Terumo, TS-A400LK) was pierced at the piercing position of the rubber stopper. Penetrate the rubber stopper. Repeat this needle sticking operation 30 times, and then
Filter the water and count the number of fine particles on the filter paper. Evaluation is 2μ
The number of fine particles having a size of m or more was confirmed with a microscope, and the number was used. Table 1 shows the results.

(Measurement of Resistance to Needle Sticking / Needle Removal) The caps of the above Examples and Comparative Examples were measured for resistance to needle sticking / needle removal under the following conditions, and the average values and the results are shown in Table 1 below. . In each test, 10 samples were used, and a new test needle was used for each sample. Also,
The following three types of needles were used for the test. Needle 1 Terumo plastic needle, TS-A400LK Needle 2 JMS plastic needle, JY-A600CNJ Needle 3 JMS stainless steel needle, JY-A200CN

Using an autograph S-500D manufactured by Shimadzu Corporation, the maximum value (kgf) of the resistance value when the test needle penetrates into the center at a speed of 200 mm / min and the maximum value (kgf) of the resistance value when the test needle is withdrawn. kgf) was measured and the average value was adopted. The smaller the value, the easier it is to treat as a cap, indicating good results.

[0032]

[Table 1]

As is evident from Table 1, it was found that the medical cap of the present invention, as compared with the medical cap of the comparative example, had less foreign matter such as rubber even after repeated needle sticks. In particular, a remarkable effect was observed in Examples 1 and 3 having low JIS A hardness. On the other hand, in the cap piercing test, the cap of Comparative Example 2 was often mixed with fine particles such as rubber. Further, the cap of Comparative Example 1 shows some improvement in the needle stick test. However, when the plug after the test results was confirmed, it was confirmed that the laminate film was partially peeled off and the rubber plug was exposed on the surface. It is considered that the mixing of fine particles increased with this. In addition, a step of laminating a rubber stopper is required at the time of manufacture, and there is a problem that multiple steps are required.

[0034]

According to the present invention, there is provided a medical cap in which a rubber stopper is provided in a casing, wherein the casing is made of a thermoplastic elastomer. The rubber and the rubber compounding agent are not eluted, and a medical cap excellent in needle stick resistance and holding force against needle detachment can be provided.

[Brief description of the drawings]

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

FIG. 2 is a schematic sectional view showing an embodiment of the medical cap of the present invention.

FIG. 3 is a view showing an example of a manufacturing process of the medical cap of the present invention.

FIG. 4 is a view showing one embodiment of use of the medical cap of the present invention.

FIG. 5 is a schematic sectional view showing an example of a conventional medical cap.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Medical cap 2 Rubber stopper 3 Casing 31 Thin film part

Claims (3)

[Claims] 1. A medical cap in which a rubber stopper is provided in a casing, wherein the casing is made of a thermoplastic elastomer. 2. The medical cap according to claim 1, wherein a bottom portion of the plug for needle puncture is integrally formed as a component of the casing. 3. The medical cap according to claim 1, wherein the thermoplastic elastomer has a JIS A hardness of 40 ° or more and 95 ° or less.