JP2000135267A - Plug body for medical container, and manufacture thereof - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a plug body for a medical container having excellent chemicals sealability, capable of preventing liquid leak in piercing and after removing a needle, with little micro-fragment generating when pierced, with small piercing resistance, securely supporting a rubber play by an outer supporting body, and economically excellent. SOLUTION: This play body comprises a rubber plug 5 and an outer supporting body 4 of a synthetic resin, at least one surface of an upper and a lower surfaces of a circular part 51 having a protruded cross section provided on an outer side part of the rubber plug 5 is inclined to become thinner for a vertical thickness toward the center of the rubber cap 5, and the outer supporting body 4 is formed on the outer side part including the upper and the lower surfaces of the circular part 51 having the protruded cross section.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a plug for a medical container made of synthetic resin used for infusion and the like, and particularly to a case where a needle for injecting or discharging a drug solution is punctured or withdrawn from a rubber stopper of an infusion container. The present invention relates to an economical plug body with extremely small generation of minute debris without liquid leakage and falling off of a rubber plug.

[0002]

2. Description of the Related Art A needle made of metal, resin or the like is punctured into a rubber stopper of a plug provided in an infusion container for discharging a drug solution and co-injecting other drugs. For this reason, this rubber stopper is generally required to have the following characteristics. That is, the resistance at the time of puncturing the needle is as small as possible, and the resistance at the time of withdrawal is large enough not to come off due to an unexpected pulling external force during use. There is no leakage or leakage of the chemical solution, it is securely sealed, and there is no liquid leakage at the puncture part within a practical time after puncturing, and the hole is quickly closed at the time of needle removal, ensuring liquid tightness Need to be done. In addition, the elution of harmful substances into the drug solution from the drug solution contact surface and the generation of minute debris during needle puncture must be minimized.

Heretofore, there are several types of rubber plugs and rubber plug support structures, and improvements have been proposed. For example, a common thing is to provide a continuous notch on the circumference of the outer peripheral portion of a cylindrical rubber stopper, and sandwich it from above and below so as to fit into the notch by two separately formed synthetic resin supports. It is kept by doing. In this method, the sealing property of the drug solution is poor, and the rubber stopper is easy to fall off from the support when puncturing a thick plastic needle when the hardness of the rubber is soft, while on the other hand, when stiff, the resistance at the time of puncturing increases and cracks easily occur, In addition, the risk of liquid leakage during needle removal increases. There is also an example in which a separator is integrally formed on the inner support to prevent liquid contact on the inner surface of the rubber stopper.Dropping of the rubber stopper occurs and it is difficult to separate the rubber stopper. Is not preferred because of the large number of small fragments generated.

[0004] As a method of further improving these, a thin synthetic resin film is laminated on the surface of the rubber stopper,
The synthetic resin external support and the synthetic resin film disposed outside are melted and bonded, or the rubber stopper is inserted into a mold and the synthetic resin is used as a support and injection molded, and the film and the injected resin are used. (Japanese Patent Application Laid-Open No. 2-1275) has been proposed to increase the hermeticity of a chemical solution and the supporting force against falling off by melting and bonding. However, when laminating a synthetic resin film on a rubber stopper,
The process of manufacturing rubber stoppers becomes complicated, and there are manufacturing problems such as the generation of minute debris in the film, the deterioration of yield, and the increase in cost when punching out rubber stoppers. Was not always at a satisfactory level.

[0005]

DISCLOSURE OF THE INVENTION The present invention has a function required for a plug for a medical container, not only for hermeticity of a medical solution, but also for prevention of liquid leakage at the time of puncturing and after needle withdrawal, and at the time of puncturing at the time of puncturing. Very low cost, low puncture resistance, reliable support to prevent the rubber plug from falling off from the outer support even when puncturing a thick plastic needle, and excellent economical faucet for medical container The purpose is to provide the body.

[0006]

Means for Solving the Problems In order to solve the above-mentioned problems, the present inventors have conducted intensive studies, and as a result, molded an external support of a plug body by injection molding or injection compression molding by inserting a rubber stopper. In this method, the present inventors have found that a plug for a medical container which solves the above problem can be obtained by forming the rubber plug into a specific shape, and completed the present invention. The present invention relates to a medical container plug in which a rubber plug is previously subjected to a compressive stress from the outside to apply compression in the radial direction, without impairing its excellent liquid leakage preventing property, and without using a laminated film, it is practically sufficient. With rubber stopper support and chemical sealability,
An object of the present invention is to provide an economical plug for a medical container with extremely small generation of small fragments and a simple manufacturing process.

That is, the present invention provides [1] a rubber stopper and a shell support made of synthetic resin, wherein at least one of the upper and lower surfaces of an annular portion having a convex cross-section provided on the outer part of the rubber stopper faces the center of the rubber stopper. A medical container spout which is inclined so that the thickness in the vertical direction becomes thinner, and wherein the outer shell support is formed on an outer portion including the upper and lower surfaces of the annular portion having the convex cross section,
[2] The plug for a medical container according to the above [1], wherein the outer diameter of the top surface portion of the rubber plug is larger than the outer diameter of the bottom portion, [3] The convex cross-section annular portion provided on the outer portion of the rubber plug. A height or depth of at least one part or all of the upper and lower surfaces is 0.1
The medical container plug according to the above [1] or [2], provided with a plurality of concave or convex portions or an annular groove or convex line of not less than mm, [4] a puncture provided on a top surface of a rubber plug. The medical container plug according to any of [1] to [3], wherein the minimum distance between the guide recess and the recess provided on the bottom surface at a position corresponding to the recess is 2 mm to 4 mm. as well as

[5] In a method of manufacturing a plug for a medical container by injection molding or injection compression molding by inserting a rubber stopper, a resin injection port for forming an outer shell support is provided by:
The medical container according to any one of [1] to [4], wherein a mold provided below the center of the thickness of the outermost peripheral side surface of the annular portion having a convex cross section provided on the outer portion of the rubber stopper is used. The above object has been achieved by developing a method of manufacturing a plug body.

[0009]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, the present invention will be described in detail with reference to the drawings. The rubber stopper 5 used for the plug for a medical container of the present invention has a resistance to a chemical solution to be used, an amount of an eluted substance, and the like. It is necessary to use one that conforms to the standard. Although not shown, the rubber stopper 5 is usually provided with a plurality of circular or conical recesses 52 or annular holes at predetermined positions on the upper surface 6 of the rubber stopper to facilitate puncturing of a puncture needle attached to an infusion tube. It is common practice to provide projections.

A synthetic resin shell support 4 is provided around the rubber plug 5 to fix the rubber plug 5 and an outlet opening of a cylindrical synthetic resin port 2 normally attached to the synthetic resin infusion container 1. And sealed in a liquid-tight manner. The port 2 referred to here is for filling the infusion container 1 with the liquid and for facilitating the passage of the liquid at the time of use. Further, the port 2 is easy to grasp by hand when the needle attached to the infusion tube is withdrawn and pierced.
It has a hollow cylindrical shape having an appropriate length and diameter so that the punctured needle does not damage the infusion container 1. The material has appropriate rigidity in order to satisfy the above-mentioned function and the joining property with the infusion container 1, is formed of the same material or the same material as the joining portion of the infusion container 1, and is selected so that it can be melt-bonded to the infusion container. .

The external support 4 of the rubber plug 5 is formed of the same material or a material containing the same material as the portion to be welded to the port 2 and the rubber plug 5 for welding to the port 2. Specifically, as the material of the port 2, a synthetic resin mainly composed of polyethylene or polypropylene is used according to the material of the infusion container 1. Therefore, the outer shell 4 is also made of a synthetic resin mainly composed of polyethylene or polypropylene, but is not necessarily limited to the same kind of material as long as it can be joined by heat welding or another joining method.

When a resin of such a material is used around the rubber stopper 5, a certain compressive force is applied to the rubber stopper 5, and the needle hole is quickly closed after the needle is pulled out to prevent liquid leakage. It is preferable that the rubber plug 5 is compressed at the boundary between the rubber plug 5 and the outer shell support 4 so that they are in close contact with each other so that leakage of the chemical solution does not occur. In order to obtain such a state, the rubber stopper 5 is inserted into a mold, and the outer support 4 is formed by injection molding or injection compression molding of a molten resin in a space provided around the rubber stopper 5. Form 4
As a result, it is optimal to reduce the diameter of the rubber plug in the radial direction by applying a constant pressure. This molding method is disclosed in JP-A-8-31.
No. 7961 describes this in detail.

In the rubber plug of the present invention, as shown in FIGS. 2 to 4, at least one of the upper and lower surfaces of the annular section 51 having a convex cross section provided on the outer peripheral side face has a thickness in the vertical direction toward the center of the cylinder. The thickness X is the largest on the outside of the annular section 51 of the convex cross section, and the thickness Y on the inside thereof is
Must be smaller than this. Such a plug can be manufactured by inserting a rubber plug 5 and forming the outer shell support 4 on the outer peripheral surface including the upper and lower surfaces by injection molding or compression molding. Here, if the outer peripheral side surface of the rubber plug 5 does not have a convex cross-section but has a flat shape in the vertical direction, the rubber plug 5 has a convex cross-sectional annular portion against a vertical load (pulling force) such as puncture. Since there is no narrowly-spaced neck formed by the upper surface 57 and the lower surface 58, the holding force is low, the resistance is weak, and it falls off relatively easily. Moreover, the convex section annular portion 5
If the upper and lower surfaces of 1 are parallel or inclined so that the thickness increases toward the center of the cylinder, the resistance is further reduced, which is not practical.

The upper and lower surfaces of the rubber stopper 5 convex cross-section annular portion do not necessarily have to be flat.
The provision of 5 further enhances pull-out resistance. Also, the larger the angle with respect to the horizontal and the longer the length in the diametrical direction (narrowing width), the greater the resistance to falling off. The outer diameter and the thickness in the vertical direction of the rubber stopper 5 and the outer shell support 4 have a product function as the infusion container 1 and restrictions on a manufacturing process. Generally, the outer diameter of the outer shell support 4 is 10 to 30 m.
m and a thickness in the range of about 5 to 20 mm are used.

Further, if the outer diameter S of the flat portion 6 on the top surface side of the rubber stopper 5, that is, the side on which the infusion needle is punctured is larger than the bottom surface, that is, the outer diameter T of the flat portion 7 facing the infusion container side, it falls off. Resistance increases. If the outer diameter of the flat part 6 and the outer diameter of the flat part 7 are the same, or conversely, if the outer diameter T of the flat part 7 is small, the falling resistance becomes small. The resistance increases as the diameter difference increases. If the diameter T of the flat portion 7 is too small, the outer support 4 formed on the lower side of the annular portion of the rubber plug 5 when the needle pierced from the top surface penetrates. There is a possibility that the puncture operation may be hindered by contacting the lower part of the rubber stopper, and the diameter difference (ST) varies depending on the thickness of the rubber stopper 5 and the size of the rubber stopper 5, but in practice, it is 1
It is preferably within a range of 10 mm to 10 mm.

Further, a plurality of or continuous small concave portions 54 or small convex portions 58 are provided on at least a part or all of the inclined upper surface 57 and lower surface 58 of the annular portion 51 having the convex cross section of the rubber plug 5 so as to fall off. Is further increased. These small concave portions and small convex portions are effective only on one side, but are most effective if provided on both upper and lower surfaces. The shape of the convex portion may be a plurality of independent protrusions such as a columnar, hemispherical, or conical shape, or continuous protrusions such as an annular or spiral shape, or a combination of both, and the height must be 0.1 mm or more. The higher the height and the larger the area of the bottom surface of the protrusion, the more effective. desirable. The area of the bottom surface of the small convex portion is selected as large as possible according to the height.

The same effect can be obtained by employing a small concave portion instead of the small convex portion. In this case as well, a plurality of independent holes such as a cylinder, a hemisphere, a cone or the like, a continuous groove such as an annular or spiral shape, and a combination of both may be used, and a depth of 0.1 mm or more is required. The depth is more effective, but if the depth is too deep compared to the hole diameter, the resin is not sufficiently filled in the hole when forming the outer shell support 4 and the effect is reduced. Also, holes from the upper and lower surfaces may penetrate. The hole diameter is selected as large as possible within a range that does not cause harmful deformation due to resin pressure.

Further, the rubber plug 5 is likely to drop off from the outer support 4 when the penetration resistance of the needle to be punctured is large. Specifically, as the diameter of the needle becomes larger, the rubber plug 5 becomes detached.
Although the friction coefficient between the needle and the needle is large, the penetration resistance increases and the needle easily falls off. Therefore, in addition to devising a method of increasing the falling resistance value of the outer shell support 4 and the rubber plug 5 itself as described above, as a result of various studies aimed at reducing the penetration resistance of the needle and substantially preventing the falling, It has been found that it is optimal to set the distance between the puncture guide concave portion 52 provided on the top surface 6 of the base 4 and the concave portion 53 provided on the bottom surface 7 at a position corresponding to the concave portion to 2 to 4 mm. . If this distance is smaller than 2 mm, the performance of preventing liquid leakage after needle removal is reduced, and the distance is 4 mm.
When the ratio exceeds, the effect of reducing the needle penetration resistance tends to be insufficient. The shape of the puncture guide concave portion 52 provided on the top surface 6 does not need to be specified as long as it does not hinder the puncture of the needle, but is usually circular or conical, and a plurality of required numbers can be provided. The concave portion 53 provided on the inner surface 7 is a circular concave portion.

When the rubber plug 5 is an elastic body, it is easily deformed by the injection pressure of the resin when the rubber plug 5 is inserted into a mold and the molten resin is injection-molded from the outside. In order to prevent liquid leakage after needle removal, the injection port (gate) is of course arranged so that resin pressure is uniformly applied to the entire rubber stopper from around the rubber stopper. In the case of a shape in which the upper and lower surfaces are inclined so that the thickness becomes thinner toward the center of the cylindrical rubber stopper, the pressure is mainly due to the bias of the pressure caused by the flow of the resin. Depending on the size, a bending moment acts on the thinnest portion of the annular portion 4 of the convex cross section to deform the rubber plug, so that a desired shape may not be obtained after the molding is completed. Although the degree of this deformation varies depending on the position of the resin injection port of the rubber stopper 5, it has been found that the deformation can be greatly reduced by providing the injection port on the bottom surface side of the center of the thickness X of the annular section 4 having the convex section. Was. When the injection port is provided on the upper surface side from this position, the pressure generated at the time of resin injection acts downward, so that the convex-section annular portion of the rubber plug is easily deformed downward. As a result, even in the case of a rubber stopper having an annular portion having a convex cross section, which is difficult to perform injection molding, etc., a medical container stopper which can prevent liquid leakage during puncturing and after needle withdrawal can be efficiently and efficiently produced. Molded.

[0020]

Industrial Applicability The present invention is excellent in sealing property of a drug solution, has little leakage at the time of puncturing or after needle withdrawal, and does not drop off a rubber plug from an outer shell support even at the time of puncturing with a thick plastic needle. We have developed a plug for medical containers that is easy to manufacture and has high productivity with less generation of fine fragments. An infusion container using the present medical container plug is safe, easy to operate, and reliable, and can be widely used in the medical field.

[Brief description of the drawings]

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

FIG. 2 is an example of a sectional view of the plug of the present invention.

FIG. 3 is another example of a sectional view of the plug body of the present invention.

FIG. 4 shows still another example of the plug body of the present invention.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Infusion container main body 2 Port 3 Plug 4 Outer support 5 Rubber stopper 51 Convex section annular part 52 Puncture guide concave part 53 Needle guide part 54 Small concave part 55 Small convex part 57 Convex section annular part upper surface 58 Convex sectional annular part lower surface 6 Rubber stopper top surface 7 Rubber stopper bottom surface 8 Resin inlet S Outside diameter on top surface side of rubber stopper T Outside diameter on bottom surface side of rubber stopper X Thickness of outer peripheral side portion of convex section annular portion Y Neck of convex section annular portion Thickness

 ──────────────────────────────────────────────────続 き Continuing on the front page (72) Inventor Hitoshi Saito 3-2-2 Chidoricho, Kawasaki-ku, Kawasaki-shi, Kanagawa Prefecture Showa Denko K.K. No. 2 Showa Denko KK

Claims (5)

[Claims] 1. A rubber plug and an outer shell support made of synthetic resin, wherein at least one of upper and lower surfaces of an annular portion having a convex cross-section provided on an outer portion of the rubber plug has a thickness in a vertical direction toward a center of the rubber plug. A plug for a medical container, characterized in that the plug is inclined so as to be thin, and an outer supporting body is formed on an outer portion including upper and lower surfaces of the annular portion having the convex cross section. 2. The plug for a medical container according to claim 1, wherein the outer diameter of the top surface of the rubber plug is larger than the outer diameter of the bottom surface. 3. A plurality of recesses or protrusions having a height or depth of 0.1 mm or more or a plurality of recesses or protrusions on at least one of upper and lower surfaces of an annular portion having a convex cross-section provided on an outer portion of the rubber stopper. The plug for a medical container according to claim 1 or 2, wherein the groove or the ridge is provided. 4. The minimum distance between the puncture guide concave portion provided on the top surface of the rubber plug and the concave portion provided on the bottom surface at a position corresponding to the concave portion is 2 mm to 4 mm. The plug for a medical container according to any one of the preceding claims. 5. A method of manufacturing a plug for a medical container by injection molding or injection compression molding by inserting a rubber stopper, wherein an injection port of a resin forming an outer support is provided on an outer portion of the rubber stopper. The method for manufacturing a plug for a medical container according to any one of claims 1 to 4, wherein a mold provided below the center of the thickness of the outermost peripheral side surface of the annular portion having the convex cross section is used.