JP2001314486A - Stopper body for infusion container - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a stopper for a medical container, which closely seals chemicals, prevents the leakage of the chemical when a needle is stuck or after it is pulled out, controls the generation of microscopic fragments at the time of stinging, reduces the stinging resistance, receives a secure support for a rubber stopper from an external support body and is cost-efficient. SOLUTION: The stopper body for an infusion container comprises a column- shaped rubber stopper 5 and an external support body of a synthetic resin formed on the periphery of the rubber stopper. An annular section with a convex section is formed on the rubber stopper and the top and the bottom surfaces of the annular section with a convex section are flat toward the center of the column. At the same time the external support body is formed on the peripheral sides of the rubber stopper including the top and the bottom surfaces of the annular section with a convex 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 liquid infusion container made of synthetic resin used for drip infusion and the like, and more particularly to piercing a rubber stopper portion of a liquid infusion container with a needle for injecting or discharging a drug solution.
The present invention relates to an economical plug body which is free from liquid leakage and rubber stopper detachment when pulled out, and has extremely small generation of small fragments.

[0002]

2. Description of the Related Art A needle made of metal, resin, or the like is pierced into a rubber stopper of a plug body provided in an infusion container for discharging a drug solution and co-injection of another drug. The characteristics described are required. That is, the resistance at the time of puncturing the needle is as small as possible, the resistance at the time of withdrawal is large enough not to be pulled out by unexpected pulling external force during use, and it is securely held and sealed so that there is no dropout during operation and leakage of chemical solution In addition, there is no liquid leakage at the puncture part within a practical time after the puncture, and it is necessary to close the hole promptly at the time of needle removal to ensure liquid tightness. In addition, it is necessary to reduce the elution of harmful substances into the drug solution and the generation of minute fragments during needle puncture.

Hitherto, there are several types of rubber plugs and rubber plug support structures, and improvement proposals have been made. For example, what is often seen is that a notch is provided continuously on the outer periphery of a cylindrical rubber stopper, and a separately formed 2
It is held by being sandwiched from above and below by two synthetic resin supports so as to fit into the notches. In this method, the sealing properties of the drug solution are poor, and if the rubber hardness is soft, the rubber stopper tends to fall off from the support when puncturing a thick plastic needle, while if it is hard, the resistance at the time of puncturing increases and cracks are likely to occur. Leakage increases at the time of needle.

There is also an example in which a separating film is integrally formed on a lower support for the purpose of preventing liquid contact on the lower surface of the rubber plug, and the rubber plug is less likely to fall off, but the separating film is thicker due to molding restrictions. Therefore, it is not preferable that many small fragments are generated at the time of puncturing. Further, as a method for improving these, a thin synthetic resin film is laminated on the surface of the rubber stopper, and the synthetic resin film and the synthetic resin external support disposed outside thereof are heated and fused, or the rubber stopper is sealed. Is inserted into a mold, injection-molded using a synthetic resin as a support, and the film and the injected resin are fusion-bonded to each other to increase the hermeticity of the chemical solution and the supporting force against falling off (Japanese Patent Laid-Open No. 2-1275).
Publication). However, when laminating a synthetic resin film on a rubber stopper, the manufacturing process of the rubber stopper becomes complicated, and there are manufacturing problems such as generation of small debris of the film, deterioration of yield, and increase in cost when punching the rubber stopper. In addition, the degree of generation of minute fragments when puncturing a thick plastic needle 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 hermetic sealing of a drug solution, but also for prevention of liquid leakage at the time of puncturing and after needle withdrawal, and the removal of minute debris at the time of puncturing. A medical container opening that has extremely low occurrence, has low puncture resistance, has reliable support for preventing the rubber stopper from falling off from the outer support even when puncturing a thick plastic needle, and is economically excellent. It is intended to provide a plug.

[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, have been able to insert rubber stoppers.
In the method of molding the external support of the plug body by injection molding or injection compression molding, it is possible to obtain a medical container plug body that solves the above problem by forming the rubber plug into a specific shape. The present invention has been completed. The present invention is directed to a transfusion container closure in which a compression stress is applied to a rubber stopper in advance from the outside to impart compression in the radial direction, without impairing its excellent liquid leakage prevention property, without using a laminated film, and 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 cylindrical rubber stopper and an outer support formed on the outer periphery of the rubber stopper, and an annular portion having a convex cross section is formed on the outer peripheral side surface of the rubber stopper. Infusion in which the upper and lower surfaces of the annular portion having a convex cross section are substantially horizontal with respect to the central axis of the rubber plug, and the outer peripheral support is formed on the outer peripheral surface including the upper and lower surfaces of the annular portion having a convex cross section of the rubber plug. Container stopper, [2] At least one surface of the upper and lower surfaces of the convex-section annular portion provided on the outer peripheral side surface of the rubber stopper has a height and / or depth of 0.1 mm on a part or the whole thereof. The translucent container plug according to the above [1], wherein the plurality of and / or the continuous small concave portions and / or the small convex portions are provided. The plug for an infusion container according to the above [1] or [2], which is larger than the outer diameter of the bottom portion. 4] and puncturing guiding recess provided in the top surface of the rubber stopper, to no 2mm minimum distance between the needle guide recess provided on the bottom surface at a position corresponding to the recess 4
The plug for an infusion container according to any one of the above [1] to [3], wherein the rubber plug is reduced in diameter in the radial direction. [6] In the method for producing a plug for an infusion container by injection molding or injection compression molding by inserting a rubber plug into a mold, the resin forming the outer shell support is preferably used. The above-mentioned [1] to [5], wherein the injection port is provided below the center of the up-down width of the outermost peripheral side surface of the annular portion having a convex cross section provided on the outer side surface portion of the rubber plug. The above object has been achieved by developing a method for manufacturing a plug for a medical container according to any one of the above.

[0008]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, the present invention will be described in detail with reference to the drawings. FIG. 1 is a diagram showing an example of a cross-sectional view of a transfusion container plug of the present invention. The infusion container plug 3 is formed of a cylindrical rubber plug 5 and a rubber plug outer support 4 on the outer peripheral side of the rubber plug 5. In order to increase the pull-out resistance on the outer peripheral side surface of the rubber stopper 5,
An annular portion 51 having a convex cross section is formed, and a flat portion 6 is formed on the top surface side of the rubber plug 5, and a flat portion 7 is formed on the bottom surface of the rubber plug 5. In addition, a puncture guide concave portion 52 is formed in the flat portion 6 and a needle guide concave portion 53 is formed in the flat portion 7 in order to make it easier to puncture the puncture needle.

In the present invention, the upper surface 56 and the lower surface 57 of the annular portion 51 having a convex cross section are horizontal with respect to the center axis of the rubber plug 5 from the viewpoint of increasing the pull-out resistance and reducing the variation. is necessary. In addition, from the problem of accuracy in the form at the time of manufacturing, it is sufficient that the “horizontal” is substantially horizontal. The outer diameter and the thickness in the vertical direction of the rubber stopper 5 and the outer shell support 4 are appropriately determined from an overall balance in consideration of restrictions in the manufacturing process. Generally, the outer diameter of the outer shell support 4 is 10 to 30 mm, and the thickness is 5 to 2 mm.
A range of about 0 mm is used.

A plurality of and / or continuous small concave portions 54 and / or small convex portions 55 are provided on at least one surface of the upper surface 56 or the lower surface 57 of the annular portion 51 having a convex cross section. Resistance to shedding further increases. The small concave portion and the small convex portion are effective even if provided on one of the upper surface 56 and the lower surface 57 of the convex-section annular portion 51.
It is most effective if provided on both upper and lower surfaces.

The shape of the small projection 55 may be a plurality of independent projections such as a column, a hemisphere, a cone, or the like, or a continuous projection such as an annular or spiral shape, or a combination of both.
1 mm or more is required. The higher the height and the larger the area of the bottom surface of the projection, the more effective. However, if it is too high compared to the bottom area, it will be deformed by the resin pressure at the time of forming the outer support 4, so that the height is practically up to about 1 mm. 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 pore size is selected as large as possible within a range that does not cause harmful deformation due to resin pressure.

Furthermore, if the outer diameter S of the top surface side of the rubber stopper 5, that is, the plane portion 6 on the side where 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. Resistance to shedding 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. As the diameter difference increases, the resistance increases. If the diameter T of the flat portion 7 is too small, when the needle pierced from the top surface penetrates, the convex-section annular portion 51 of the rubber plug 5
May contact the lower part of the outer shell support 4 formed on the lower side of the rubber stopper, which may hinder the puncture operation. Specifically, it is preferably within a range of 1 mm to 10 mm.

Further, the rubber stopper 5 usually falls off from the outer support 4 when the penetration resistance of the punctured needle is large. More specifically, the larger the diameter of the needle is, the more the rubber stopper 5 is removed.
The greater the coefficient of friction between the needle and the needle, the greater the penetration resistance and the easier it is to fall off. Therefore, in addition to increasing the detachment resistance 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 detachment, the rubber stopper It is optimal that the distance between the puncturing guide recess 52 provided on the top surface 6 of the needle 5 and the needle guide recess 53 provided on the bottom surface 7 at a position corresponding to the recess is 2 to 4 mm. I found it. This distance is 2m
If it is smaller than m, the liquid leakage prevention performance after needle removal will be reduced, and if it is more than 4 mm, the effect of reducing the needle penetration resistance tends to be insufficient. Puncture guide recess 5 provided on top surface 6
The shape of 2 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. A recess 53 provided on the inner surface 7
Is a circular recess.

The rubber stopper 5 of the present invention conforms to the standards for the test method for plastic drug containers and the rubber stopper test for infusion prescribed by the Japanese Pharmacopoeia with respect to the resistance to the used chemical solution, the amount of eluted substances and the like. It is necessary to use what is.

The outer shell 4 is fixed around the rubber plug 5 to fix the rubber plug 5 and is welded to the outlet opening of the cylindrical port 2 normally attached to the infusion container 1 to be liquid-tight. Stopper. The port 2 referred to here is for filling the infusion container 1 with the liquid or for facilitating the passage of the liquid at the time of use. Further, the port 2 is easy to grasp by hand when inserting and removing the needle attached to the infusion tube, 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 of the support 4 has appropriate rigidity to satisfy the above-mentioned function and the joining property with the infusion container 1, and is formed of the same material or the same material as the joining portion of the infusion container 1, and is adhered to the infusion container by adhesion. It is selected to be able to. Specifically, since the synthetic resin mainly composed of polyethylene or polypropylene is used as the material of the port 2 in accordance with the material of the infusion container 1, the outer shell 4 is also made of the synthetic resin mainly composed of polyethylene or polypropylene. It is used, 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.

Next, a method for producing the plug 3 for an infusion container of the present invention will be described. First, the rubber stopper 5 according to the present invention is inserted into a mold. Next, the space provided around the rubber stopper 5 is filled with a molten resin, and injection molding or injection compression molding is performed to form the outer shell support 4 and to manufacture the infusion container mouth plug according to the present invention. . Such a molding method is described in detail in JP-A-8-317961. In the present invention, in order to prevent the infusion container plug body from being manufactured in a state where the rubber stopper is deformed, the resin injection port of the mold is placed in the vertical direction of the outermost peripheral side of the convex section annular portion of the rubber stopper. It is necessary to be provided below the center of the width X.
This is because the rubber plug 5 is an elastic body, so that when the rubber plug 5 is inserted into a mold and the molten resin is injection-molded from the outside, the rubber plug is easily deformed by the injection pressure of the resin. In particular, when the rubber stopper 5 has an annular portion with a convex cross-section on the outer peripheral side portion as in the present invention, a bias of pressure mainly due to the flow of the resin occurs in the annular portion with the convex cross-section, and the deformation of the rubber plug increases. . The degree of deformation of the rubber stopper varies depending on the position of the resin injection port of the mold. However, by providing the injection port below the center of the thickness X of the annular section 51 of the convex section, it is possible to greatly reduce the deformation. I found it. In the transfusion container plug 3 manufactured by this method, the rubber plug 5 is reduced in diameter in the boundary portion between the rubber plug 5 and the outer shell support 4 and is brought into close contact with the outer shell support 4. And liquid tightness is sufficiently ensured.
As a result, even in the case of a rubber stopper having an annular portion having a convex cross-section that is difficult to perform injection molding, etc., a stopper for an infusion container capable of preventing liquid leakage at the time of puncturing and after needle removal is efficiently and efficiently produced. Can be molded.

[0018]

Industrial Applicability The present invention is excellent in the sealing property of a drug solution, has little liquid leakage at the time of puncturing or after needle withdrawal, and does not drop off of a rubber stopper from an outer support even at the time of puncturing of 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 example of a sectional view of a plug for an infusion container of the present invention.

FIG. 2 is an external view of the medical container of the present invention.

[Explanation of symbols]

 DESCRIPTION OF REFERENCE NUMERALS 1 infusion container 2 port 3 plug 4 outer shell support 5 rubber plug 51 convex section annular section 52 puncture guide concave section 53 needle guide concave section 54 small concave section 55 small convex section 56 convex section annular section upper surface 57 convex section annular section lower surface 6 Rubber stopper top surface 7 Rubber stopper bottom surface S Outside diameter of rubber stopper top surface side T Outside diameter of rubber stopper bottom surface side X Vertical width of convex section annular part

──────────────────────────────────────────────────続 き Continued on the front page (51) Int.Cl. ⁷ Identification symbol FI Theme coat ゛ (Reference) A61J 1/00 315Z F-term (Reference) 3E084 AA12 AA24 AB05 BA02 CA01 CC04 CC05 CC08 CC10 DA01 DC04 DC05 DC10 EB01 FD13 4F202 AA04 AA11 AD05 AD23 AH57 AH63 CA11 CB01 CB12 CK06 4F206 AA04 AA11 AD05 AD23 AH57 AH63 JA07 JB12 JQ81

Claims (6)

[Claims] 1. A rubber stopper having a cylindrical shape and an outer peripheral support formed on an outer periphery of the rubber stopper.
An annular portion having a convex cross-section is formed, and upper and lower surfaces of the annular portion having a convex cross-section are substantially horizontal with respect to a central axis of the rubber plug, and the shell support includes upper and lower surfaces of the annular portion having a convex cross-section of the rubber plug. A plug for an infusion container formed on the outer peripheral side surface. 2. At least one of upper and lower surfaces of an annular portion having a convex cross section provided on an outer peripheral side surface portion of a rubber plug has a plurality and / or continuous portions having a height and / or a depth of 0.1 mm or more on at least a part thereof. The plug for an infusion container according to claim 1, wherein a small concave portion and / or a small convex portion are provided. 3. The infusion container plug according to claim 1, wherein the outer diameter of the top surface of the rubber stopper is larger than the outer diameter of the bottom surface. 4. The minimum distance between the puncture guide recess provided on the top surface of the rubber plug and the needle guide recess provided on the bottom surface at a position corresponding to the puncture is 2 mm to 4 mm. 4. The plug for an infusion container according to any one of 3. 5. The plug for an infusion container according to claim 1, wherein the rubber stopper is reduced in diameter in a radial direction. 6. A method for manufacturing a plug for an infusion container by injection molding or injection compression molding by inserting a rubber stopper into a mold, wherein the resin inlet forming the outer shell support is provided on the outer peripheral side surface of the rubber stopper. 6. The plug for an infusion container according to any one of claims 1 to 5, wherein the plug is provided below a center of a vertical width of an outermost peripheral side surface of the annular portion having a convex cross section provided in the portion. Manufacturing method.