JP2002028219A - Mouth plug for infusion solution bag - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a rubber plug which increases the tightening force to an impalement needle and the closing force of a hole formed by the impalement of the needle. SOLUTION: The mouth plug body to be mounted in the main body aperture of an infusion solution bag made of a synthetic resin is in a tight contact state by receiving the compressive stress from a rubber plug contour supporting body made of a synthetic resin at the entire flank in the cylindrical part of the rubber plug. At least one of the top surface and base surface of the rubber plug is contracted in diameter by 1 to 10% and the top surface or the base surface is bulged.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a plug for an infusion container made of synthetic resin used for infusion and the like and a method for producing the same. The present invention relates to a plug body which does not leak liquid even when piercing, pulling out or repeating these steps, and a method for manufacturing the same.

[0002]

2. Description of the Related Art In recent years, glass containers and synthetic resin bottles and bags have been widely used as infusion containers used for infusions and the like. The latter made of synthetic resin is considered to be suitable in terms of breakage resistance at the time. On the other hand, regarding the rubber stopper for an infusion container, in addition to mere insertion of a needle for infusion, insertion of a needle for injecting a drug solution for performing infusion while mixing another drug solution, withdrawal of a needle accompanying stopping of infusion, etc. It is susceptible to damage that impairs the inherent sealing properties of rubber stoppers. That is, on the contact surface between the infusion container and the rubber stopper, at the time of needle puncture and withdrawal, the contact state becomes worse due to a large shear stress particularly during the repetition thereof,
It is easy to cause liquid leakage. Further, the recovery of the rubber stopper after the needle is withdrawn is also important. If the needle puncture hole is not immediately closed after the needle is withdrawn, the liquid will leak. As described above, despite the necessity of inserting and plugging a rubber stopper for inserting a drug solution extraction / injection needle into the opening of the infusion container, it is necessary to insert or remove the needle for drug solution extraction / injection or to repeat the operation. There is a limit in the prior art for plugging to such an extent that liquid leakage does not occur.

[0003] Recently, various proposals have been made in order to respond to the request for the rubber stopper. For example, from the viewpoint of fusing and integrating a rubber stopper into the opening of the infusion container body made of synthetic resin, a rubber stopper laminated with a synthetic resin film is used, and the laminated part is gripped by a synthetic resin support. In addition, a technique for preventing a liquid from leaking by fusing a plug body obtained by fusing the laminate film and the support to the opening of the infusion container main body has been introduced (for example, Japanese Patent Application Laid-Open No. HEI 2 (1990)). -12275, JP-A-3-205141 and JP-A-5-84275). First, JP-A-2-127
Japanese Patent Publication No. 5 (1995) discloses a plug having a rubber plug laminated with a synthetic resin film, in which concave portions are provided on the upper and lower surfaces of the rubber plug, and which are sandwiched between outer peripheral supports having projecting ribs fitted into these concave portions. Can be disclosed. In this case, as a clamping method, a rubber stopper is clamped from above and below by an outer support body divided and formed into two members in advance and then fused and integrated with the two members, and a rubber stopper is inserted into an injection mold. There is disclosed a case in which a state in which a rubber stopper is clamped by an outer shell support is created by fixing the outer shell support at a stretch by injection molding. on the other hand,
In each of JP-A-3-205141 and JP-A-5-84275, when the outer peripheral edges of the upper and lower surfaces of a rubber plug laminated with a film are sandwiched and integrated by a synthetic resin shell support, the synthetic resin is used. A method in which the outer shell support is divided into two inner and outer cylindrical bodies and the like, and the laminated rubber stopper is sandwiched by the split outer shell supports by using an injection molding process, and integrated by heat fusion. Proposed.

In the above conventional method, a rubber plug outer peripheral edge is sandwiched by a synthetic resin shell support divided into two parts, and both are thermally fused to form a plug, and the plug is infused with an infusion solution. Since it can be liquid-tightly fixed at a position close to the opening of the container body, it achieves its purpose in terms of firmly fixing the rubber plug, but considering the various stresses received by the rubber plug in the plug, First, when the outer peripheral edge portion of the rubber plug is sandwiched from above and below by the closed annular shell support divided into two parts, it receives compressive stress due to the sandwiching, and this compressive stress is applied to the rubber stopper by the above-described method. A tensile stress is generated from the center of the portion surrounded by the holding portion toward the holding portion of the peripheral portion. This tensile stress is particularly large at the top or bottom surface of the rubber stopper, and when the needle for an infusion container is pierced, the needle is tightened.
It is clear that the material of the rubber stopper works in the direction of reducing the inherent elasticity for contraction. Also, a rubber stopper is previously inserted into an injection molding die, fixed with a pressure fixing die having a smooth pressing surface, and a synthetic resin for molding a shell support is injected into a mold cavity, and a rubber plug is inserted. In the method of molding the rubber plug outer shell support integrated with the rubber plug outer shell support, the rubber plug outer shell support is slightly flattened while receiving compressive stress for sandwiching and fixing the rubber plug in the top / bottom direction. It is molded, and the rubber stopper is subjected to a tensile stress directed to the outer peripheral direction by the compressive stress, and a case in which the rubber stopper is sandwiched between the two outer shell support members, such as a decrease in a puncture needle tightening force. The same can be said.

[0005] On the other hand, there is also disclosed an attempt to increase the holdability of a pierced needle by externally fitting a ring to one end of a rubber stopper and compressing and reducing the diameter of the rubber stopper by the compressive stress thereof (actually). JP-A-2-106236). However, this technology forcibly fits a special ring for compressing and reducing the diameter of only the top side of the rubber plug, and in effect, on the top side of the body side of the rubber plug. This is a method of fitting the ring by providing a step by cutting. Further, the material of the ring is required to be very high in rigidity, which causes problems such as thickening of the ring and detachment of the ring. In any case, in this method, the rubber plug is abnormally deformed due to the compressive stress applied only to a part of the side surface on the top surface side, for example, deformation such as bulging of the side surface other than the top surface, diameter increase, etc. In addition to this, it becomes difficult to plug the infusion container itself, the stability of the needle puncture is not obtained, and the complexity involved in fitting the ring is unavoidable, which is not a preferable method.

[0006]

According to these conventional methods, the inherent tightening force of the rubber stopper is reduced, and more specifically, the needle holding force in the piercing state of the infusion container needle, the removal of the needle, etc. Causing a decrease in the strong closing force of the later hole,
Problems such as lack of stability of needle penetration are not solved. Therefore, an object of the present invention is not only to attach the rubber stopper to the opening of the infusion container main body strongly, but also not to impair the inherent elasticity of the rubber stopper, but also to tighten the needle with respect to the piercing needle and the needle puncture. An object of the present invention is to provide a rubber stopper in which the closing force of the hole generated by the passage is further increased. In addition,
An object of the present invention is to provide a method that does not involve abnormal deformation of a rubber plug despite the compressive stress from the side surface of the rubber plug.

[0007]

Means for Solving the Problems In order to solve the above-mentioned problems, the present inventors have made intensive studies and as a result, integrated the rubber stopper and the synthetic resin shell support. By applying a compressive stress from the side to the center to reduce the diameter of the rubber plug (reducing the diameter), it was found that the needle tightening force at the time of needle penetration and the strong closing force of the hole after needle removal increased. The present invention has been completed. That is, the gist of the present invention is as follows.

(1) In a plug having a cylindrical rubber plug and a rubber plug outer shell support attached to an opening of a main body of a synthetic resin infusion container, an outer peripheral edge of a top surface and a bottom surface of the rubber plug. And at least the whole body part side surface of the body part whole side surface,
The rubber plugs are in close contact with each other under compressive stress from the rubber plug outer shell support, and at least one of the diameters of the top surface and the bottom surface of the rubber plug is reduced by 1 to 10%, and the air contact portion on the top surface or The liquid contact part on the bottom is a bulged and deformed transfusion container plug. (2) The plug for an infusion container according to the above (1), wherein a projection (protrusion) larger than the diameter of the top surface and the bottom surface is provided in the center of the side surface of the trunk portion of the rubber stopper. (3) The plug for an infusion container according to the above (1) or (2), wherein the outer peripheral edge of the liquid contact portion on the bottom surface of the rubber stopper or the outer peripheral edge of the air contact portion on the top surface has an annular rib. (4) An annular concave groove is formed in at least one outer peripheral edge of the top surface or the bottom surface of the rubber plug, and the outer peripheral edges of the top surface and the bottom surface of the rubber plug and the entire side surface of the trunk are rubber plugs. 4. The plug for an infusion container according to any one of the first to third aspects, which is subjected to a compressive stress from the outer shell support. (5) The plug for an infusion container according to any one of the above (1) to (4), wherein the close contact between the rubber stopper and the outer peripheral support of the rubber stopper is fusion. (Sixth) A synthetic resin film is laminated on at least the bottom surface of the bottom surface and the trunk side surface of the rubber stopper,
5. The plug for an infusion container according to any one of the first to fourth aspects, wherein at least a part of the adhesion between the rubber plug and the rubber plug outer shell support is fusion bonding of the film and the rubber plug outer shell support.

Hereinafter, the contents of the present invention will be described in detail. The rubber stopper used in the present invention is sufficient as long as it has resistance to the used chemical solution, including those conventionally used for the mouth stopper of the infusion container. In addition, those that conform to the standards of the rubber stopper test method for infusion are practically used.

[0010] The close contact between the rubber plug and the rubber plug shell support is also achieved by the rubber plug receiving the compressive stress of the rubber plug shell support from all sides of its trunk.
If a rubber stopper laminated with a synthetic resin film is used and thermal fusion is performed between the film and the outer peripheral support of the rubber stopper, the above-mentioned adhesion is more effective. This synthetic resin film is effective in terms of liquid-tight sealing by fusion of the rubber stopper and the rubber stopper outer shell support as described above, but if it is present on the bottom surface, that is, on the surface in contact with the chemical solution, the film is made of the chemical solution. Since the leaching of the rubber stopper component is suppressed, this is also a useful means.

The method for producing the rubber stopper laminated with the synthetic resin film is not particularly limited, but an uncrosslinked rubber material is sandwiched between the synthetic resin films (see, for example, JP-A-2-1275). The method described in the official gazette) or a method in which a rubber stopper is formed at the same time as flowing onto the film and crosslinking is preferred. However, considering the contact relationship between the rubber stopper and the rubber stopper outer shell support, and the liquid contact relationship between the rubber stopper and the chemical solution, it is preferable that at least the bottom surface be laminated. Further, it is more preferable that the rubber stopper is laminated on the side surface of the body of the rubber stopper from the viewpoint of liquid tight sealing. The synthetic resin film used here is required to be a material having a fusibility with the rubber plug outer shell support or to have resistance to a chemical solution, but the fusibility of the former is particularly required. In such a case, polyethylene, polypropylene, ethylene / vinyl acetate copolymer and the like can be exemplified. If the latter is particularly required for chemical resistance, polyester, polytetrafluoroethylene and the like are preferably used. When both are required, polyethylene, polypropylene and the like are particularly preferable. The thickness of the laminating film is not particularly limited, but is preferably about 10 to 100 μm in consideration of easiness of lamination and fusion force.

The contact surface between the rubber stopper and the rubber stopper shell support is
A method of mechanically integrating the rubber stopper and the rubber stopper outer shell support is also preferably employed, since the needle is constantly subjected to shearing peeling stress when the needle is pierced or pulled out. By mechanically integrating the rubber stopper with a protrusion having a desired width, which is larger than the diameters of the top and bottom surfaces, in the center of the side of the body, the resistance against the shear peeling stress can be considerably improved. Is obtained. Note that the center of the side of the trunk here means that the center of the protruding portion is substantially near the center of the side of the trunk, and it is not necessary to be at the exact center position. Further, the width and height of the protruding portion are not particularly limited, but a protruding portion having a trapezoidal cross section is particularly preferable in view of shearing peeling stress. The rubber stopper outer support may be formed only on the side of the trunk of the rubber stopper, but may further extend from the side of the trunk to the top and / or bottom peripheral edge of the rubber stopper, and By forming the reinforcing frame reaching the circumferentially provided annular groove, the integration of the two is further improved. If an annular rib is provided along the outer peripheral edge of the liquid contact portion on the bottom surface of the rubber stopper or the outer peripheral edge of the air contact portion on the top surface, the annular rib is useful for positioning the rubber stopper on the mold surface during insert injection molding described later. However, the formation of the annular rib itself functions as a rib for preventing deformation of the rubber plug, which is a preferable embodiment.

The method of causing the rubber plug to receive a compressive stress from the rubber plug outer peripheral support on the entire side surface of the body and reducing the diameter of the top or bottom surface of the rubber plug is not particularly limited. In the method of forcibly inserting the rubber plug into the rubber plug outer shell support having an inner diameter smaller than the outer diameter of the above, the insertion work becomes more difficult as the difference between the two diameters is larger. However, so-called insert molding, in which a rubber plug is inserted in advance in a split mold, and a rubber plug outer peripheral support is formed on the entire side surface of the trunk or on the outer peripheral edge of the top surface and the bottom surface on all side surfaces of the trunk. According to the method described above, this object can be easily achieved and is preferable.
In this case, even if the rubber stopper is subjected to compressive stress on all sides of its trunk, the volume of the rubber stopper itself is invariable, so that only the diameter of at least one of the top surface or the bottom surface according to the present invention is involved, It is impossible to reduce the volume of the rubber plug due to volume reduction, and in order to reduce the volume of the top or bottom part by reducing the diameter, it is necessary to increase the volume in other parts of the rubber plug, that is, accompany the volume displacement. No.

In the present invention, the rubber plug generates a phenomenon in which the volume decrease in the vertical direction on the top or bottom surface, that is, a swelling deformation, is caused by the volume decrease due to the compressive stress from the entire side surface of the body. It is intended to solve the problem. However, in the present invention, from the viewpoint of preventing the leakage of liquid during the original purpose of piercing the needle into the rubber stopper of the infusion container, pulling out or repeating these, the higher the compressive stress is, the more preferable it is. If the diameter of the rubber stopper becomes large and the tightening force becomes too large, it becomes difficult to pierce and withdraw the needle itself, which may hinder the infusion operation. In consideration of these points, in the present invention, the range of diameter reduction of the top surface or the bottom surface of the rubber stopper needs to be 1 to 10%, preferably 2 to 8%, and more preferably 3 to 8%.
It was found to be 6%, but in this case, if it is less than 1%, the desired effect cannot be obtained, and a liquid leakage phenomenon is observed as in the conventional case. On the other hand, if it exceeds 10%, a considerable amount of force is required to penetrate the needle into the rubber stopper or to pull out the needle, which hinders the infusion operation as described above, and both are not preferable. From the viewpoint of the liquid leakage resistance and workability, the case of 2 to 8% is more effective. The case where the diameter reduction is 3 to 6% is the most preferable range comprehensively.

The plug for an infusion container according to the present invention comprises a rubber stopper or a rubber stopper laminated with a synthetic resin film and a rubber stopper outer shell supporting part. Extend further from the bottom along the side of the trunk,
If an annular rib projecting outward is formed as a flange at the end, the flange can be provided also at the opening of the infusion body made of synthetic resin, thereby facilitating the connection between the two. Ultrasonic bonding and other fusion methods commonly used for synthetic resin molded articles can be applied to the bonding of the two. Further, without extending the rubber plug outer shell support portion as described above, the plug body formed only on the side of the trunk of the rubber plug, or the top and bottom of the rubber plug from the side of the trunk and the side of the trunk further. A plug body having a reinforcing frame formed by extending in a rib shape along the outer peripheral edge thereof along the outer periphery may be formed. In this case, the plug body is formed in advance in the opening of the infusion body made of synthetic resin. A method of fitting the plug body into the received plug body receiving portion and performing liquid-tight fusion between the two by various known heat fusion means can be adopted as an effective method.

The present invention also provides a method of manufacturing a plug having a rubber plug and a rubber plug outer shell support. In particular, a rubber plug is inserted in advance into a split mold, and a rubber plug outer shell is provided. It discloses a method of injection molding a support. According to the method for manufacturing a plug according to the present invention, a rubber plug is inserted into a mold in advance, and the top or bottom surface thereof is temporarily fixed to the surface of the mold in order to position the rubber plug. As a temporary fixing method for this positioning, a rubber stopper fixing suction hole is opened in the surface of the mold opposite to the top or bottom surface of the rubber stopper, and the rubber stopper is suction-fixed at a predetermined position on the surface of the mold. Although there is a method, a method in which an annular groove is provided at a predetermined position of a mold and an annular rib provided along an outer peripheral edge of a top surface or a bottom surface of a rubber plug is inserted because positioning is simpler is preferable.
In the present invention, in order to adopt a method of compressing the rubber stopper from the entire surface of the body and reducing the diameter, when the method of inserting the annular rib is employed, the annular groove is formed so that the annular rib can also be reduced in diameter. It is necessary to widen a little toward the center of the ring.

The positional relationship between the mold surface on which the rubber stopper is positioned and the opposite mold surface is such that a gap of about 0.2 to 0.4 mm is left if there is no flat recess described later. Preferably, there is. The reason for this is that it is preferable to leave a deformation space for the rubber plug when the rubber plug is compressed from the side surface of the body. This is because there is no risk of intrusion. When there is the flat concave portion, it may be in contact with the opposite mold surface.

On the mold surface to which the rubber stopper is temporarily fixed or on the opposite mold surface, a flat concave portion large enough to be covered by the bottom or top surface of the rubber stopper having a reduced diameter is formed. This constitutes a place where the rubber plug bulges and deforms due to compression from the side of the rubber plug body during injection molding. The flat recess achieves its purpose if it is located in at least one of the upper and lower molds. However, if it is desired to increase the degree of diameter reduction of the top surface or the bottom surface, it is preferable to increase the volume of one recess rather than to increase the volume of one recess. Forming the flat concave portion in the mold can easily cause deformation such as diameter reduction and swelling of the rubber plug. The rubber stopper fixing suction hole may be opened in the flat concave inner surface. Further, when a flat concave portion is formed on the mold surface opposite to the mold surface to which the rubber stopper is temporarily fixed, it is desirable to provide a vent hole for discharging air accompanying the bulging deformation of the rubber stopper.

The volume of the above-mentioned flat concave portion needs to be enough to absorb the increase in the thickness of the rubber plug (the amount of bulging deformation on the top or bottom side) due to the diameter reduction of the bottom or top surface of the rubber plug. There is. The increase in the thickness (bulging deformation) of the rubber plug due to the above-mentioned injection pressure is easier to cause over the widest possible area of the top surface or the bottom surface. Smallness is enough. Therefore, the depth of the concave portion is determined by the desired degree of diameter reduction, and cannot be specified unconditionally.
In order to reduce the diameter by%, it is preferable to be about 0.2 to 5 mm in consideration of the deformability based on the material of the rubber stopper. If it is less than 0.2 mm, it becomes difficult to sufficiently swell the rubber plug, and furthermore, the degree of diameter reduction becomes insufficient, and it becomes difficult to achieve the intended purpose. Conversely, swelling deformation exceeding 5 mm is generally unlikely to occur, so a depth exceeding 5 mm is of little significance.

The simplest method of giving a compressive stress to the side surface of the body of the rubber plug to reduce the diameter of the top surface or the bottom surface is to increase the injection molding pressure of the rubber plug outer shell support.
There is also a method of utilizing the molding shrinkage characteristics of the synthetic resin by forming the rubber plug outer shell support body on the top or bottom side of the rubber plug so as to be thick, and it is preferably used.

In order to control the diameter of the top or bottom surface of the rubber stopper so as to take a desired value in the range of 1 to 10% diameter reduction, in addition to the method of controlling the injection resin pressure, the top or bottom surface of the rubber stopper is controlled. The most convenient method is to detect the degree of deformation with a strain gauge. The relationship between the resin pressure in the mold and the diameter reduction, and the strain received by the gauge terminal in the recess by the rubber plug bulging into the recess of the mold are determined in advance, and the predetermined resin pressure and the strain value are maintained during injection molding. Through the steps of maintaining the holding pressure and cooling, the desired degree of diameter reduction can be easily obtained.

The mold surface in contact with or opposed to the top or bottom surface of the rubber plug is formed as a nested mold, so that the fixed suction hole or vent hole of the rubber plug can be easily installed. In addition, when a sintered compact of air-permeable metal powder is used for the insert mold, the installation of the fixed suction hole or the vent hole becomes simple, and this is a preferred embodiment.

The cavity of the injection mold is composed of a mold surrounding the top and bottom sides of the rubber stopper and a mold surrounding the body.
It is preferable from the viewpoint of uniform injection molding that the injection gate be provided on a plane outside the body of the rubber stopper and parallel to the top surface and the bottom surface and at the same interval. The need for an exhaust hole for the internal gas is the same as in normal injection molding.

Next, the present invention will be described with reference to the drawings. However, the present invention is not limited by the description of the drawings. FIG. 1 is a longitudinal sectional view of a cylindrical rubber stopper 1a used in the present invention, and FIG. 2 is a rubber stopper 1 which is the same as the rubber stopper of FIG.
b is grasped by the rubber stopper outer support 2b, and this is
FIG. 3 is a longitudinal sectional view of a state in which the rubber plug 1c is laminated with a synthetic resin film on a bottom surface and a body side surface of the rubber plug shown in FIG.
It is a longitudinal cross-sectional view of a state in which this is fused to an infusion container 4s,
FIG. 4 is a perspective view of the rubber stopper of FIG.
FIG. 5 is a cross-sectional view of a rubber stopper 1d in which the film is laminated on the bottom surface and a part of the side surface. FIG. 5 illustrates a rubber stopper 1e which is the same as the rubber stopper of FIG. FIG. 6 is a vertical cross-sectional view of a state in which
An annular groove is formed on the top and bottom surfaces of the cylindrical rubber stopper of
FIG. 7 is a longitudinal sectional view showing a state in which a rubber stopper 1f on which the film is laminated is gripped by a rubber stopper outer peripheral support 2f and fused to the infusion container 4s on a part of the bottom and side surfaces.
1g of rubber stopper with an annular rib formed on the bottom of the rubber stopper
8 is a longitudinal sectional view of FIG. 8, and FIG. 8 shows a case where the same rubber stopper 1h as the rubber stopper shown in FIG.
FIG. 9 is a longitudinal sectional view showing a state in which the rubber plug is fused to the rubber plug shown in FIG. 7, and FIG. 9 shows a state in which the same rubber plug 1i as the rubber plug shown in FIG. FIG. 10 is a longitudinal sectional view in a state where the plug shown in FIG. 9 is inserted into the opening of the infusion container main body and a heater is arranged, and FIG. 11 is a longitudinal sectional view of FIG. FIG. 12 is a longitudinal sectional view showing a state of being inserted and integrated by the method shown in FIG.
FIG. 13 is a longitudinal sectional view showing an example of a method for insert injection molding a plug according to the present invention, and FIG. 13 is a longitudinal sectional view showing an example of another method.

The details will be described below. The rubber plug shown in FIG. 1 is an example of a simple columnar rubber plug 1a, and shows a longitudinal sectional view thereof. The rubber stopper 1a includes a top surface 1ap, a bottom surface 1aq, and a body side surface 1ar.

FIG. 2 uses the same rubber stopper 1b as in FIG.
The plug body in a state where it is gripped under compression by a rubber plug outer shell support 2b from the trunk side surface 1br is shown. Because it is under the compression,
The top surface 1bp and the bottom surface 1bq are bulging and deforming. Such deformation exerts high pressure on the needle pierced for infusion and contributes to the strong closure of the hole after withdrawal of the needle. On the other hand, in order to improve the integrity of the rubber plug and the rubber plug outer shell support, the rubber plug outer shell support 2b is made of the rubber plug body side surface 1b.
r, not only the gripping frame 2br, but also a reinforcing frame 2bp is formed on the outer peripheral edge on the top surface, and a reinforcing frame 2bq is also formed on the outer peripheral edge on the bottom surface. In addition, the reinforcing frame 2bq on the outer peripheral edge on the bottom side extends toward the infusion container to form a flange 2bs at the tip for fusion with the infusion container 4s, and FIG. 2 shows the fused state.

FIG. 3 shows the use of a rubber stopper in which a synthetic resin film 3 is laminated on the bottom surface (chemical solution contact surface side) 1cq and the body side surface 1cr of the same rubber stopper 1c as the rubber stopper of FIG.
Almost in the same manner as in the case of FIG. 2, the gripping frame 2cr of the rubber plug outer shell support 2c is formed on the side surface of the trunk of the rubber plug, and the outer peripheral edge of the bottom is a plug body formed with the reinforcing frame 2cq. Since the rubber plug 1c and the rubber plug outer shell support 2c are integrated via the synthetic resin film, a reinforcing frame may not be provided on the top surface of the rubber plug. Infusion container 4s with rubber stopper outer shell support 2c
It has the flange 2cs on the side and is fused to the container as in the case of FIG. The top surface 1cp is swelled and deformed by pressurization from the side of the trunk. The bottom side 1cq is flat because a manufacturing method that does not swell and deform is employed.

FIG. 4 shows a projection 1 having a substantially trapezoidal cross section at the center of the side wall 1dr of the rubber stopper 1d, which is the same as the rubber stopper of FIG.
dk formed with a rubber stopper 1d and a bottom surface 1dq
3 shows a state in which a synthetic resin film 3 similar to the case of FIG. 3 is laminated on the entire surface and a part of the body side surface. 1d
p is the top surface.

FIG. 5 shows the same rubber stopper 1e as in FIG.
The same film 3 is laminated on the bottom 1eq and a part of the body side 1er, and the body side 1er is used.
The plug is grasped by the rubber plug outer shell support 2e under pressure from the side, and the rubber plug and the rubber plug outer shell support are strongly adhered to each other, but the portion where the laminate film is present is integrated by fusion. ing. The protrusion 1ek of the rubber stopper is provided on the upper gripping frame 2e of the gripping frame 2er on the side of the trunk of the rubber stopper outer peripheral support 2e.
It engages with p and the lower holding frame 2eq, and is strongly integrated under the anchoring effect. The rubber stopper swells and deforms to the top surface 1ep side similarly to the case of FIG. 3, but the bottom surface 1eq side is flat. The flange 2es of the rubber stopper shell support is an infusion container 4
fused with s.

FIG. 6 shows an annular groove 1 on the outer peripheral edge of the top surface 1fp and the bottom surface 1fq of the rubber plug 1f which is the same as the cylindrical rubber plug of FIG.
fg, each of which is formed by laminating a synthetic resin film 3 on the bottom surface and a part of the body side surface 1fr, and from the body side surface, a gripping frame 2fr of the rubber stopper outer support 2f. Shows the plug obtained by gripping under pressure. Reinforcing frames 2fp and 2fq are formed on the rubber plug outer shell support 2f and extend along the top surface and bottom surface of the rubber plug to the above-mentioned annular groove. The rubber plug and the rubber plug outer shell support are formed by the annular shape of the reinforcing frame. It is strongly integrated by the anchoring effect to the concave groove and the fusion through the film, and a liquid-tight seal is provided. As in the case of FIG. 5, a flange 2fs for fusion to the infusion container 4s is formed and fused to the rubber stopper outer shell support.

FIG. 7 shows a rubber stopper 1g identical to the rubber stopper of FIG. 4 with an annular rib 1gm formed on the outer periphery of the bottom surface 1gq, the top surface 1gp, the bottom surface 1gq, and the trunk side surface 1g.
r, but a protrusion 1gk similar to the case of FIG. 4 is formed on the side surface of the body. A part of the side surface and the bottom surface of the body are laminated with the same synthetic resin film 3 as above including the annular rib. The annular rib is effectively used for positioning and temporarily fixing the rubber plug to the mold surface during insert injection molding, and is also effective for preventing abnormal deformation of the rubber plug when a needle is inserted.

FIG. 8 shows a rubber plug 1h which is the same as the rubber plug shown in FIG. 7 and a synthetic resin film 3 similarly laminated on the same rubber plug 1h as shown in FIG. Fig. 3 shows a plug obtained by gripping under pressure. Rubber stopper is top surface 1hp, bottom surface 1hq, trunk side surface 1hr
However, there is a protrusion 1hk on the side of the body, and an annular rib 1hm on the bottom, and the film 3 is laminated on a part of the bottom and the side of the body. The protruding portion 1hk meshes with the upper gripping frame 2hp and the lower gripping frame 2hq of the gripping frame 2hr of the rubber stopper outer support, and is strongly integrated under the anchoring effect. Note that a flange 2hs is formed below the rubber plug outer shell support in the same manner as that shown in FIG. 6 and the like, and is fused and integrated with the infusion container 4s.

FIG. 9 shows a plug body in a case where the rubber plug outer shell support is constituted only by a gripping frame and does not extend to the infusion container side as shown in FIG. The same rubber stopper 1i as the rubber stopper of FIG. 7 is used, and the top surface 1ip, the bottom surface 1iq, and the trunk side surface 1
and a protrusion 1i similar to the above on the side of the body.
k, an annular rib 1im similar to that described above is formed on the bottom surface, and a film 3 is laminated on a part of the bottom surface and a part of the side surface of the body in the same manner as described above. Also, the protrusion 1ik
Meshes with the upper gripping frame 2ip and the lower gripping frame 2iq of the gripping frame 2ir constituting the rubber plug outer shell support 2i, and is strongly integrated under the anchoring effect. An annular convex portion 2it is formed on the outer peripheral portion of the upper gripping frame 2ip, and this annular convex portion constitutes a fusion portion when being fused and integrated with a mouth portion of an infusion container described later.

FIG. 10 shows a rubber plug 1i shown in FIG. 9 on which a film 3 similar to the above is laminated and integrated with a rubber plug outer shell support 2i to form a plug whose top and bottom surfaces are swollen and deformed. This figure shows a state in which the plug is inserted into a plug receiving port 4t provided at the mouth of the infusion container. The plug receiving port has a plug receiving section 4tq at its lower end, and an annular convex portion of a rubber plug outer support above. 2
It has an extended portion 4tp extending longer than it, and the extended portion, together with the annular convex portion, is a portion that contributes to a liquid-tight seal between the plug and the plug receiving port. The liquid-tight seal between the plug body and the plug body receiving port is achieved by pressing the molten sealer 5 which is disposed above FIG. 10 and is movable in the direction of the arrow. That is, the sealer has a heater 5c, but has a concave portion on the plug body side for melting and integrating the rubber plug outer shell support and the plug body receptacle, and the concave portion has a bottom portion 5a and an inclined side surface portion 5b. By pressing the sealer, the extended portion 4t of the plug body receptacle is formed.
The p is flowed in a molten state inward, while the annular convex portion 2it of the upper gripping frame is also in a molten state, and both form a fused portion 5t.

FIG. 11 shows a state in which the fused portion 5t is formed. When the pressing force is strong, as shown in the figure, the fused portion extends to the upper surface of the upper holding frame, but this does not impair the intended liquid-tight sealing property. In the figure, reference numeral 1i denotes a rubber stopper, 3 denotes a synthetic resin film, 2i denotes a rubber stopper outer shell support, 4t denotes a mouth plug receiving port, and 5t denotes a fused portion.

FIG. 12 shows an example of a method for manufacturing a plug according to the present invention (similar to the plug shown in FIG. 8). 1 g of a rubber stopper laminated with a synthetic resin film is inserted into an insert injection mold composed of split molds A, B, C and D.
c shows a state before the resin for the rubber plug outer shell support is injected. The mold A is combined with the mold B as an insert mold. The mold A is slidably in contact with the outer peripheral edge of the top surface of the rubber stopper 1g. Since the mold B is not in contact, a space Bb is formed in a flat concave shape on the top surface side of the rubber plug, and the rubber plug is in a state where it can receive the bulging deformation of the top surface. The possibility of sliding movement between the mold A and the top surface of the rubber stopper 1g is a necessary condition when compressive stress is applied to the side surface of the rubber stopper body and the top surface is reduced in diameter. The mold B is provided with a vent hole Ba for exhaust, so that the air in the flat recess Bb can be exhausted at the time of the bulging deformation.

The mold C is located on the side surface, and the injection gates Cb into which the resin is injected in the direction of the arrow are provided at the same height and at equal intervals. Ca is a vent hole for injection molding. The mold D is a mold arranged on the bottom side of the rubber stopper, is provided with an annular groove Da, and an annular rib 1gm of the rubber stopper is inserted into the annular groove for positioning and temporary fixing. However, when a compressive stress is applied to the side surface of the rubber stopper body, the width of the annular groove needs to be larger than the width of the annular rib so that the rubber stopper can slide and move while reducing the diameter of the bottom surface of the rubber stopper. And the space Db
Most preferably, the fitting and positioning are performed between the outer inner wall of the annular groove Da and the outer wall of the annular rib 1gm. Moreover, it must be slidable between the annular rib and the bottom of the annular groove. In addition, the exhaust accompanying the diameter reduction of the bottom surface of the rubber stopper is performed through the vent hole Dc, and the vent hole is also used for suction fixing for temporarily fixing the rubber stopper. The resin injected into the cavity Cc can apply a compressive stress to the side surface of the body of the rubber plug at the cavity Cd at a predetermined pressure to reduce the diameter.

FIG. 13 shows another example of a method of manufacturing the plug according to the present invention (similar to the plug shown in FIG. 9). The injection mold is composed of split molds E, F, G and H. An insert mold H, which is a sintered compact of metal powder, is incorporated in the center of the mold E. The sintered compact has a fine gas passage formed therein. Hole Ba, vent or suction hole Dc
It is not necessary to form a vent like this. Mold H
The flat recess Ha is formed on the surface facing the rubber plug 1d, but the outer periphery of the flat recess is slidably in contact with the rubber plug. This contact relationship is shown in FIG.
This is to expect the same effect as in the case of. The top surface is subjected to compressive stress from the side surface of the rubber stopper body, and the top surface swells and deforms into the flat concave portion, but the internal air U is discharged in the direction of the arrow through the fine passage in the mold H.

The mold G has a flat concave portion Gb formed on a surface Ga facing the rubber stopper, and the rubber stopper is attached to the surface of the mold G by suction through a fixed suction hole Gc opened on the inner bottom surface of the concave portion. Is temporarily fixed. Synthetic resin is injected into the cavity K for molding the rubber plug outer shell support from the injection gate Ea formed by the molds E and F, and when a predetermined pressure or more is applied, compressive stress is applied to the body side surface of the rubber plug. The rubber stopper is reduced in diameter, but the corresponding volume change is absorbed by swelling and deformation in the flat recesses Ha and Gb. By adopting such a molding method, the top surface and the bottom surface of the rubber plug are reduced in diameter, and the top surface and the bottom surface are swelled and deformed. Note that F
a is a vent hole for injection molding.

[0040]

According to the present invention, a compressive stress is applied from all sides of the body of the rubber plug, but by forming a concave portion on the mold surface facing the top surface or bottom surface of the rubber plug, the concave portion is formed. Swelling deformation is possible, which allows the top surface or bottom surface to be reduced in diameter, and increases the needle clamping force to such an extent that liquid leakage does not occur even if a needle is pierced from the top surface to the bottom surface, or,
Even if the needle is pulled out, a force capable of immediately and strongly sealing the hole is generated, and the effect of eliminating the possibility of liquid leakage is exhibited.

[Brief description of the drawings]

FIG. 1 is a sectional view of a cylindrical rubber stopper.

FIG. 2 is a vertical cross-sectional view showing a state in which the plug body in which the rubber plug of FIG. 1 is gripped by a rubber plug outer shell support is fused to an infusion container.

FIG. 3 is a longitudinal sectional view showing a state in which a plug body laminated with a film and holding the rubber plug of FIG. 1 with a rubber plug outer shell support member is fused to an infusion container.

FIG. 4 is a longitudinal sectional view of the rubber stopper of FIG. 1 having a protruding portion on a side surface of a trunk portion and being laminated with a film.

FIG. 5 is a longitudinal sectional view showing a state in which the plug body in which the rubber plug of FIG. 4 is gripped by a rubber plug outer shell support is fused to an infusion container.

FIG. 6 is a longitudinal sectional view showing a state in which a stopper body having annular concave grooves on the top surface and the bottom surface, and a rubber stopper of FIG. .

FIG. 7 is a longitudinal sectional view of the rubber plug of FIG. 4 in which an annular rib is formed on a bottom surface.

FIG. 8 is a longitudinal sectional view showing a state in which the plug body in which the rubber plug of FIG. 7 is gripped by a rubber plug outer shell support is fused to an infusion container.

9 is a longitudinal sectional view of a plug body in which the rubber plug of FIG. 7 is gripped by a rubber plug outer shell support.

10 is a longitudinal sectional view showing a state in which the plug of FIG. 9 is inserted into the opening of the infusion container main body and a sealer is arranged.

FIG. 11 is a longitudinal sectional view showing a state where the components are fused and integrated by the method shown in FIG. 10;

FIG. 12 is a longitudinal sectional view showing an example of a method for insert injection molding a plug according to the present invention.

FIG. 13 is a longitudinal sectional view showing another example of the method for insert injection molding the plug according to the present invention.

[Explanation of symbols]

1a, 1b, 1c, 1d, 1e, 1f, 1g, 1h, 1
i: Rubber stopper 1ap, 1bp, 1cp, 1dp, 1ep, 1fp, 1
gp, 1hp, 1ip top surface 1aq, 1bq, 1cq, 1dq, 1eq, 1fq, 1
gq, 1hq, 1iq: bottom surface 1ar, 1br, 1cr, 1dr, 1er, 1fr, 1
gr, 1 hr, 1 ir ... side surface 1dk, 1 ek, 1 gk, 1 hk, 1 ik ...
Projection 1fg
Annular groove 1gm, 1hm, 1im
Annular ribs 2b, 2c, 2e, 2f, 2h, 2i ...
Rubber plug outer shell support 2br, 2cr, 2er, 2fr, 2hr, 2ir ...
Holding frame 2bp, 2bq, 2cq, 2fp, 2fq ...
Reinforcement frame 2ep, 2hp, 2ip ...
Upper gripping frame 2eq, 2hq, 2iq ...
Lower gripping frame 2bs, 2cs, 2es, 2fs, 2hs ...
Flange 2it ・ ・ ・
Annular convex part 3
Synthetic resin film 4s
Infusion container mouth 4t
Plug body receptacle 4tp ...
Extension part 4tq ...
Plug body receiving part 5
Melt sealer 5a ...
Heater recess bottom 5b
Heater recess side 5c
Heater 5t ...
Fused parts A, B, C, D, E, F, G, H ...
Split mold Ga ...
Mold surface Bb, Ha, Gb ...
Flat recess Ba, Ca, Fa ...
Vent holes Cb, Ea, Dc ...
Injection gate Gc
Fixed suction holes Cc, Cd, K ...
Cavity Da ...
Annular groove Db ...
Space

 ──────────────────────────────────────────────────続 き Continuing on the front page (72) Inventor Katsushi Shirakawa 3-2 Chidori-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa Prefecture Showa Electric Works Co., Ltd. No. 3-2 Showa Denko KK Kawasaki Resin Laboratory F-term (reference) 4C066 AA09 BB01 BB02 DD01 GG07 JJ07

Claims (6)

[Claims] 1. A plug having a cylindrical rubber plug and a rubber plug outer shell support attached to an opening of a main body of an infusion container made of synthetic resin, an outer peripheral edge and a body of a top surface and a bottom surface of the rubber plug. At least all the side surfaces of the body are in close contact with each other by receiving a compressive stress from the rubber plug outer shell support made of synthetic resin, and at least one of the top and bottom diameters of the rubber plug is 1 to 10 %, And the air contact portion on the top surface or the liquid contact portion on the bottom surface is swelled and deformed. 2. The infusion container port plug according to claim 1, wherein a protrusion having a diameter larger than the diameter of the top surface and the bottom surface is provided in the center of the side of the body of the rubber stopper. 3. The plug for an infusion container according to claim 1, wherein an annular rib is provided on the outer peripheral edge of the liquid contact portion on the bottom surface of the rubber stopper or on the outer peripheral edge of the air contact portion on the top surface. 4. An annular groove is formed in at least one outer peripheral edge of a top surface or a bottom surface of the rubber plug, and the outer peripheral edges of the top surface and the bottom surface of the rubber plug and all side surfaces of the trunk are formed of rubber. 4. The plug for an infusion container according to claim 1, which is subjected to a compressive stress from the plug shell support. 5. The plug for an infusion container according to claim 1, wherein the rubber plug and the rubber plug outer shell support are adhered to each other by fusion. 6. A synthetic resin film is laminated on at least the bottom surface among the bottom surface and the body side surface of the rubber plug, and at least a part of the close contact between the rubber plug and the rubber plug outer shell support is formed with the film. 5. The plug for an infusion container according to any one of claims 1 to 4, wherein the plug is fused with a rubber plug outer shell support.