JP3634944B2 - Medical cap - Google Patents

Description

【００２７】
表１より明らかなように、実施例はほとんどすべての試験で、比較例のものよりも好結果を得ることができた。したがって、本発明の医療用キャップは、製造工程を簡便化することができると共に、針抜け防止に対する保持力に優れ、針の抜け落ち、薬品の漏れが解消される。
【００２８】
【発明の効果】
本発明は、フシを設けた栓体を有する医療用キャップであるので、針抜けに対する保持力、復元力が向上し、針抜け防止に対する保持力及び針抜け後の再シール性に優れた医療用キャップを提供することができる。
【図面の簡単な説明】
【図１】本発明の医療用キャップに用いる栓体の一部断面斜視図である。
【図２】自己密閉性試験の実験概略図である。
【図３】保持力試験の実験概略図である。
【図４】ゴムの成形工程を示すフローチャートである。
【図５】樹脂の成形工程を示すフローチャートである。
【符号の説明】
１ キャップ
２ ケーシング
３ フシ
４ 針刺し穴
５ 栓体[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a cap for a medical infusion container. More specifically, the present invention relates to a medical cap that has excellent holding force for preventing needle removal and improved resealability after needle removal.
[0002]
[Prior art]
Conventionally, rubber caps are widely used as plugs for medical caps. However, these rubber plugs undergo a complex process as shown in FIG. 4 until a molded body is obtained, and thus large-scale equipment is required. In addition, there are many kinds of additives, and scrap is generated in each process, so that the productivity is poor. That is, while the casing is manufactured by injection molding, the rubber plug body needs to be vulcanized after press molding, and it is necessary not only to assemble these after separately manufacturing, but also to raise the unit price. Had.
[0003]
In order to solve this problem, it was considered to use a thermoplastic elastomer, which is a resin having elasticity, as a cap body. In this technology, since the casing and the plug are both made of resin, they can be manufactured by simple injection molding as shown in FIG. 5 and do not require a vulcanization step as in the case of rubber plugs. The process problem is solved in that it can be obtained. Also, with this technology, an elastic body having a wide range of physical properties from soft vulcanized rubber to plastic can be obtained by changing the chemical structure of the material. Furthermore, the scrap produced in the molding process can be reused and the productivity is high.
[0004]
[Problems to be solved by the invention]
However, thermoplastic elastomers have a high residual strain and inferior rubber elasticity, and stress relaxation and creep phenomenon are likely to occur. Therefore, the holding power for needle drop prevention, which is an important element for infusion container caps, is low. There is a problem that the needle for infusion tends to fall off from. Furthermore, the resealability after needle removal is poor, and there is a problem that chemicals ooze out from the hole formed in the plug after needle removal.
[0005]
In order to solve this problem, a technique using a plug body in which rubber and a thermoplastic elastomer are overlapped is disclosed. However, a complete solution to the problem of holding force for preventing needle removal and resealability after needle removal is disclosed. However, since the rubber plug is still used, the actual situation is that the problem in the process has not been solved.
[0006]
The subject of this invention is providing the medical cap which was excellent in the retention power with respect to prevention of needle | hook removal, the resealability after needle extraction, and eliminated the problem on a process.
[0007]
[Means for Solving the Problems]
The present inventor has found that a cap excellent in holding force for preventing needle removal and re-sealability after needle removal can be manufactured by attaching a fuzz to the cap body of the cap. The invention of claim 1 is a medical cap in which a casing is provided on the casing contact surface of the plug.
[0008]
The reason why the present invention solves the above-mentioned problem is that the stress per unit is segmented by applying a fuzz to the contact surface of the plug body with the casing. That is, it is because the restoring force with respect to the stress made into the plug body increases by dividing into small pieces instead of the large side face.
[0009]
Specifically, the term “fushi” as used in the present invention means that the cap body or casing of the cap is not a circle, but a polygon, a flower shape, a star shape, or the like, or a slit or center portion extending in the center direction from the outer periphery of the body This is achieved by providing ribs extending in the circumferential direction. The size and number of slits and ribs are not particularly limited. Since the cap using the plug body of these shapes is excellent in restoring force, resealability after needle removal is improved, and liquid leakage is reduced. Further, since the resistance to stress is strong and the holding force is improved, the holding force for preventing needle dropout is also excellent.
[0010]
As the material used for the plug, a highly elastic resin is preferable. Specifically, the highly elastic resin referred to in the present invention corresponds to, for example, various thermoplastic elastomers, gel resins, or a mixture of these and rubber. These are not particularly limited in the type and material. Examples of thermoplastic elastomers include hydrogenated styrene elastomers, vinyl chloride elastomers, olefin elastomers, polyurethane elastomers, and polyester elastomers, and gel resins include polyethylene gel materials, urethane gel materials, Silicon-based gel materials, acrylic gel materials, vinyl chloride-based gel materials and the like can be exemplified as those that can be suitably used. Examples of types of rubber blended with these materials include butyl rubber, isoprene rubber, butadiene rubber, styrene butadiene rubber, chloroprene rubber, and acrylic rubber. However, since these resins are used as plugs of caps for infusion containers, it is needless to say that the resin must have appropriate physical properties. For example, even a resin corresponding to the type of gel resin described above is not included in the gel resin referred to in the present invention if it is extremely low in viscosity and cannot maintain a constant shape. Since these resins can take the same injection molding process as a resin-made casing, there is no need to assemble them separately as in the case of conventional rubber plugs. Because it is easy, all the conventional problems can be solved.
[0011]
DETAILED DESCRIPTION OF THE INVENTION
Moreover, this invention is a medical cap which provided the fistula in the casing contact surface of the stopper. Specifically, providing the casing with contact with the casing can be achieved by making the plug into a shape other than a circle, such as a polygon, a flower, or a star, or by providing slits or ribs. FIG. 1 is a partially sectional perspective view of a cap provided with a regular octagonal plug as an embodiment of the present invention. In FIG. 1, 1 is a cap, 2 is a casing contact surface, 3 is a filigree, 4 is a needle puncture hole, and 5 is a plug. Although not shown, the cap usually has a pull top lid, and the figure shows a state in which the pull top lid is removed. The needle inserted from 4 is supported by the internal stress from the plug body 5 so as not to come off. However, in the conventional plug body having no fuzz, the stress is uniformly transmitted over a wide area, so that it is restored. The power was not fully demonstrated. However, in the present invention, by providing the flange 3, the stress received by these is segmented for each flange 3, so that the restoring force of the plug body is improved, and as a result, the holding force for preventing needle removal, The resealability of the needle puncture hole 4 is improved. Of course, the present invention is not limited to these shapes, and the present invention can be achieved as long as the flies are provided in some form.
[0012]
Moreover, it is preferable that it is a highly elastic resin as a material of the plug used for the medical cap of this invention. The reason why it is preferable to use a highly elastic resin is that the production process can be performed in the same process as the casing. In other words, in the manufacturing process, the casing is molded by injection molding as is conventionally done, and it is not necessary to take a step of assembling the two after vulcanizing only the rubber pressed in a separate process. Thereafter, if the plug is injection molded into the casing, the cap is completed, so that it can be manufactured advantageously in the process. Of course, the present invention is not limited to the above manufacturing method, and the present invention can also be achieved by a method in which a plug body and a casing are separately manufactured and assembled by insert molding as in the prior art.
[0013]
The joining method of the cap of the present invention and the infusion container is not particularly limited, and may be joined by a known method. The cap of the present invention can also be applied to a stopper for piercing or holding a needle or a tube, for example, a vial stopper for a medicine or a reagent.
[0014]
【Example】
Hereinafter, the present invention will be described in detail based on examples. However, the present invention is not limited to the examples.
[0015]
The medical cap was manufactured using the plug body manufactured on the conditions described next, and this was made into each Example and a comparative example. In the examples, the insert molding is the one in which the casing and the plug are manufactured separately, and both are assembled at the time of manufacturing the cap. Indicates.
[0016]
Example 1
Material: Made by Mitsubishi Chemical, thermoplastic elastomer, trade name "Lavalon SR-04"
Shape of plug: regular hexagon, thickness 5mm
Manufacturing process: Simultaneous molding [0017]
(Example 2)
Material: Aron Kasei Co., Ltd., thermoplastic elastomer, trade name “AR-860C”
Shape of plug: regular hexagon, thickness 5mm
Manufacturing process: Insert molding [0018]
(Example 3)
Material: Cosmo Keiki Co., Ltd., gel resin, trade name "Cosmogel"
Shape of plug: regular hexagon, thickness 5mm
Manufacturing process: Insert molding [0019]
Example 4
Material: Made by Mitsubishi Chemical Corporation, thermoplastic elastomer, trade name “Lavalon SR-04” and butadiene rubber kneaded at a ratio of 8: 2 (weight ratio) Shape of plug: regular hexagon, thickness 5 mm
Manufacturing process: Simultaneous molding [0020]
(Comparative Example 1)
Material: Made by Mitsubishi Chemical, thermoplastic elastomer, trade name "Lavalon SR-04"
Plug shape: circular, 5 mm thick
Manufacturing process: Simultaneous molding [0021]
(Comparative Example 2)
Material: Butadiene rubber plug body shape: circular, thickness 5mm
Manufacturing process: Insert molding [0022]
The caps of the above examples and comparative examples were subjected to resistance measurement, self-sealing test, and holding force test for preventing needle stick and needle omission under the following conditions. The average values and the results are shown in Table 1 below. In each test, 10 specimens were used, and a new test needle was used for each specimen. The following three types of needles were used for the test.
Needle 1 Terumo plastic needle, TS-A400LK: No. 970326
Needle 2 JMS plastic needle, JY-A600CNJ: No. 970124.11.
Needle 3 JMS stainless steel needle, JY-A200CN: No. 970116.61
[0023]
(Measurement of resistance value for prevention of needle stick and needle removal)
Using the Shimadzu Autograph S-500D model, the maximum resistance value (kgf) when the test needle is allowed to enter the central portion at a speed of 200 mm / min and the maximum resistance value (kgf) when extracting the test needle The average value was measured. The smaller the number is, the easier it is to handle as a cap, indicating good results.
[0024]
(Self-sealing test)
Each sample is welded to the mouth of an infusion bottle, and the set as shown in Fig. 2 is hung with a lifting tool for 2 hours. The amount (cc / min) was measured and the average value was shown. In the figure, 1 is a cap, 6 is an infusion container, 7 is an air vent hole, and 8 is a water leak check location. The smaller the value, the less liquid leakage and the better.
[0025]
(Retention force test)
Each sample was welded to the mouth of an infusion bottle, and a 1 kg weight was suspended from the set as shown in FIG. 3 for 6 hours. Shown the number of things. In the figure, 1 is a cap, 6 is an infusion container, 7 is an air vent hole, and 9 is a 1 kg weight. The larger the value, the better the result. If the weight does not drop at all, the evaluation is 10.
[0026]
[Table 1]

[0027]
As is apparent from Table 1, the Examples were able to obtain better results than those of the Comparative Examples in almost all tests. Therefore, the medical cap of the present invention can simplify the manufacturing process, has excellent holding power for preventing needle drop, and eliminates needle dropout and chemical leakage.
[0028]
【The invention's effect】
Since the present invention is a medical cap having a stopper provided with a filiform, the holding force and restoring force against needle removal are improved, and the medical force is excellent in holding force for preventing needle removal and resealability after needle removal. A cap can be provided.
[Brief description of the drawings]
FIG. 1 is a partial cross-sectional perspective view of a plug used in a medical cap of the present invention.
FIG. 2 is an experimental schematic diagram of a self-sealing test.
FIG. 3 is an experimental schematic diagram of a holding force test.
FIG. 4 is a flowchart showing a rubber molding process.
FIG. 5 is a flowchart showing a resin molding step.
[Explanation of symbols]
1 Cap 2 Casing 3 Fushi 4 Needle Pricking Hole 5 Plug

Claims (4)

A medical cap having a casing and a plug, and having a contact surface that is in contact with the outer side surface of the plug and the inner side surface of the casing over the entire circumference,
The material of the plug is any one of a thermoplastic elastomer, a gel-like resin, or a mixture of these and rubber, and the shape of the plug has a bottom shape of any one of a polygon, a flower, and a star. A medical cap characterized by a pillar shape . The medical cap according to claim 1, wherein the shape of the plug is a pillar shape having a regular hexagonal bottom shape. The medical cap according to claim 1 or 2, wherein a material of the plug is a thermoplastic elastomer. A medical infusion container using the medical cap according to any one of claims 1 to 3.

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