JP2006254932A - Plug body for infusion container, method for producing it, mouth member for infusion container and infusion container - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a plug body for an infusion container in which a rubber plug is free from attached materials, such as foreign matters or the like, which prevents the generation of particles or harmful materials in a liquid medicine filling direction, and achieves an excellent adhesion between the rubber plug and a rubber plug outline supporting body, and also to provide a method for producing the plug body for an infusion container. <P>SOLUTION: A sealant made of synthetic resin and having a bottomed cylindrical shape is arranged on a liquid medicine contacting side of the bottom of the rubber plug. The synthetic resin seal body is arranged on the rubber plug by inserting a cylindrical section of the synthetic resin sealant into a cylindrical guide channel formed on the bottom of the rubber plug, by clamping the side face of a trunk section of the rubber plug using the cylindrical section of the synthetic resin sealant, or the like. <P>COPYRIGHT: (C)2006,JPO&NCIPI

Description

  TECHNICAL FIELD The present invention relates to a plug member of a synthetic resin-made infusion container used for infusion and the like, a method for producing the same, an infusion container mouth member, and an infusion container. In particular, the present invention relates to a plug body that does not generate fine particles or other harmful substances in the chemical solution direction from the rubber plug portion of the plug body of the infusion container, a manufacturing method thereof, an infusion container mouth member and an infusion container.

In recent years, glass containers, synthetic resin bottles, bags, etc. are widely used as infusion containers for infusion injections, etc., but the latter in terms of transportation, storage, and breakage resistance during use. Those made of synthetic resin are preferred.
On the other hand, with regard to the rubber stopper for an infusion container, a rubber stopper having a synthetic resin thin film that is larger than the outer diameter of the rubber stopper and covers the entire surface of the rubber stopper on the chemical solution contact side has been known (for example, see Patent Document 1). However, a method of manufacturing a specific member having a synthetic resin thin film by injection molding so as to cover the entire surface of the rubber plug on the chemical solution contact side, or a member in which the plug body surrounding the rubber plug and the synthetic resin thin film are integrated It has been difficult to stably produce a synthetic resin thin film, for example, to a thickness of about 0.3 mm or less by the method of injection molding. Therefore, since the synthetic resin thin film becomes thick and hard, there is a problem that the needle is crushed when the synthetic resin thin film is pierced during operation and the chemical solution is contaminated with fine particles. Therefore, as a rubber plug with reduced contamination by fine particles, a rubber plug in which a synthetic resin film is laminated on the filling chemical solution side of the rubber plug is increasingly used.

The rubber plug laminated with these films is provided with a rubber plug shell support on the side surface by insert injection molding, and the laminated rubber plug and the rubber plug shell support are integrated into a mouth plug body, Furthermore, it is used by fusing with the mouth member of the infusion container. In addition to piercing the needle for instillation, the needle for injecting the medicinal solution for infusion while mixing other drug solution, infusion stop It is necessary that the rubber stopper does not fall off even when the needle is pulled out.
That is, an important characteristic as a rubber stopper for an infusion container is that no fine particles or harmful substances are generated in the direction of the filling chemical solution, and the close contact surface between the rubber stopper outer support and the rubber stopper is inserted into a needle stopper and It is required to have an adhesion strength that does not fall off even when subjected to a large shearing stress at the time of drawing, particularly when it is repeated.

  Various proposals have been made to meet the demand for such a rubber stopper for an infusion container. For example, using a rubber plug laminated with a synthetic resin film, holding the laminated portion with a synthetic resin support, and fusing the laminated rubber plug and the support, A technique for preventing liquid leakage by fusing to a mouth member of an infusion container main body is disclosed (for example, see Patent Documents 2 to 4).

Japanese Utility Model Publication No. 56-125249 (2nd page) Japanese Patent Laid-Open No. 2-1275 (page 2) Japanese Patent Laid-Open No. 3-205141 (2nd page) JP-A-5-84275 (2nd page)

However, the rubber plugs laminated with these synthetic resin films need to be cut out from the periphery of the rubber plug at the time of manufacturing the rubber plug, and must be punched out using a mold. Therefore, the film on the side surface of the rubber plug is easily scratched, and film scraps based on the scratch adhere to the rubber plug as a product as a foreign object.
When using a rubber stopper laminated with such a synthetic resin film to form a mouthpiece for an infusion container by insert injection molding, the deposits resulting from the film scraps may be sufficiently washed before insert injection molding. Since it cannot be completely removed, a problem has been pointed out that the surface adhesion force changes due to heat at the time of injection molding and the like, and there is a possibility that the deposits may be mixed in the filling liquid during actual use.

  The present invention has been made in view of such a situation, and the problem of the present invention is that the rubber plug has no foreign matter and other foreign matters, and no fine particles or harmful substances are generated in the direction of the filling chemical solution. The present invention provides a mouthpiece for an infusion container having excellent adhesion to a rubber plug shell support and a method for producing the same. Another object of the present invention is to provide an infusion container mouth member and an infusion container using the infusion container mouth plug.

  In order to solve the above-mentioned problems, the present inventors have conducted intensive research. As a result, a bottomed cylindrical synthetic resin sealing body having a diameter smaller than the diameter of the rubber plug is attached to the chemical solution contact portion side of the bottom surface of the rubber plug. Thus, the present inventors have found that there is no generation of fine particles and harmful substances in the filling chemical solution, and that there is no leakage of the filling chemical solution when the needle is pierced, and the present invention has been completed.

That is, the present invention relates to a mouthpiece for an infusion container shown in the following (1) to (6) and a method for producing the same.
(1) In a plug body having a cylindrical rubber plug and a rubber plug shell support attached to the body opening of a synthetic resin infusion container, the thickness of the rubber plug is smaller than the outer diameter of the rubber plug on the bottom surface. A cylindrical guide groove extending in the direction, and the bottom of the rubber stopper has a cylindrical synthetic resin sealing body with a bottom and a synthetic resin sealing body inserted into the guide groove A mouthpiece for an infusion container, wherein the mouthpiece is mounted.
(2) A projection is provided on the cylindrical portion of the synthetic resin sealing body, and a latching portion is provided at a portion that contacts the projection inside the rubber plug, and the latching portion and the projection are fitted to each other. The mouthpiece for an infusion container according to (1) above, wherein
(3) The mouthpiece for an infusion container according to (1) or (2) above, wherein the rubber stopper has a protruding portion having a diameter larger than the diameter of the top surface and the bottom surface at the center of the body side surface.
(4) The above (1) to (1), wherein the synthetic resin sealing body and the rubber plug shell support are fused at the cylindrical portion and / or at the peripheral edge of the bottom portion of the synthetic resin sealing body. The mouthpiece for an infusion container according to any one of (3).
(5) The stopper for an infusion container according to any one of (1) to (4) above, wherein the rubber stopper outer support body covers the peripheral edge of the top surface of the rubber stopper.
(6) A method for producing the mouthpiece for an infusion container according to any one of the above (1) to (5), wherein a rubber stopper equipped with a synthetic resin sealing body is installed in a mold, A method for producing a mouthpiece for an infusion container, which uses an insert injection molding method in which a synthetic resin is injected to form a rubber plug shell support on the side surface of the rubber plug.

The present invention also relates to an infusion container mouth member and an infusion container shown in the following (7) and (8).
(7) An infusion container mouth member comprising the infusion container mouth plug according to any one of (1) to (5) above.
(8) An infusion container comprising the mouthpiece for an infusion container according to any one of (1) to (5) above.
In the mouthpiece for an infusion container of the present invention, “top” and “bottom” mean “outside of infusion container” and “filling liquid side of infusion container”, respectively.

  According to the present invention, as a mouthpiece for an infusion container, it was obtained by installing a synthetic resin sealing body on a rubber stopper and then integrating the rubber stopper and the rubber stopper outer support by insert injection molding. An infusion container fused with the infusion container receptacle using a mouth plug is extremely useful because there is no generation of fine particles and harmful substances in the filling chemical and there is no leakage of the filling liquid when the needle is pierced. .

Hereinafter, description will be given based on the drawings.
In the mouthpiece for an infusion container of the present invention, a cylindrical rubber stopper is provided with a bottomed cylindrical synthetic resin sealing body on the bottom side of the liquid chemical contact portion.
FIG. 1 is a longitudinal sectional view showing one embodiment of a state in which a synthetic resin sealing body is mounted on a rubber plug, and FIG. 2 is a perspective view of the synthetic resin sealing body in FIG. In FIG. 1, 1 is a cylindrical rubber plug, 1a, 1b, and 1c are the top | upper surface, bottom face, and trunk | drum side surface of a rubber plug, respectively. 1 and 2, reference numeral 2 denotes a synthetic resin sealing body, and 2a and 2b denote a cylindrical portion and a bottom portion of the synthetic resin sealing body, respectively.

  In addition, as shown as a vertical cross-sectional view in FIG. 3, the protrusion 2c is provided on the inner side of the cylindrical portion of the synthetic resin sealing body, and a locking portion is provided at a portion in contact with the protrusion inside the rubber plug. If the engaging portion and the protruding portion are fitted, the mounting can be made more reliable. In the case of FIG. 3, the protrusion 2c is provided inwardly at the upper end of the cylindrical portion, but may be provided between the upper end and the lower end. Alternatively, the upper end outward 6v5 may be used.

Further, in FIG. 1, a guide groove is provided in the rubber stopper, and the synthetic resin sealing body is mounted by inserting the cylindrical portion of the synthetic resin sealing body into the guide groove.
FIG. 4 is a longitudinal sectional view showing another example of the rubber plug provided with the guide groove. The rubber plug 1 has a cylindrical shape having a diameter smaller than the outer diameter of the rubber plug and extending in the thickness direction from the bottom surface 1b. The guide groove 1e is provided.
FIG. 5 is a longitudinal sectional view of a synthetic resin sealing body used for the rubber stopper provided with the guide groove shown in FIG. 4, and as shown in FIG. In addition to the shape similar to that of the resin sealing body, a shape in which the bottom portion is larger than the diameter of the cylindrical portion as shown in FIG. Further, in order to make it easy to attach the rubber plug provided with the guide groove shown in FIG. 4, that is, to insert the cylindrical portion of the synthetic resin sealing body into the guide groove of the rubber plug, the lower end of the cylindrical portion is provided. A small hole for venting air may be provided in the vicinity.
6 is a longitudinal sectional view showing a state in which the synthetic resin sealing body shown in FIG. 5 is attached to the rubber plug shown in FIG. 4, and the synthetic resin is inserted into the guide groove 1e provided in the rubber plug 1. FIG. The cylindrical part 2a of the sealing body 2 is inserted. The portion surrounded by a circle in FIG. 6 is as shown in FIG. 5A when the synthetic resin sealing body has the shape shown in FIG. 5A, but the synthetic resin sealing body is shown in FIG. In the case of the shape of B), it may be either (B) or (B ′).
The depth of the guide groove is preferably 3 to 12 mm when the thickness of the rubber plug is 5 to 15 mm.

The rubber plug can take various shapes, and in addition to the cylindrical shape as shown in FIG. 1, the outer diameter larger than the diameter of the top and bottom surfaces at the center of the trunk side surface as shown in FIGS. The shape etc. which provided the protrusion part 1d of the desired width | variety which has can be illustrated in the perimeter.
As described above, the contact surface between the rubber stopper and the rubber stopper outer support is subjected to shear stress when the injection needle is pierced or pulled out. However, the protrusion 1d shown in FIGS. 4 and 6 is provided. In this case, it is a preferable shape because mechanical integration is achieved and it can withstand the shear stress more reliably. In addition, the trunk | drum side surface center here means that the center of this protrusion part exists in the center vicinity of the trunk | drum side surface substantially, and does not need to be an exact center position. Further, the width and height of the protrusion are not particularly limited, but a protrusion having a trapezoidal cross section is particularly preferable in terms of shear stress resistance.

  The material of the rubber stopper is sufficient if it is resistant to the filling chemical solution in the container, including those conventionally used for the stopper of the infusion container. A material that conforms to the standard of the rubber plug test method is practically used. Further, a thermoplastic elastomer may be used instead of rubber.

In the bottomed cylindrical synthetic resin sealing body used in the present invention, the thickness of the cylindrical portion is suitably 0.1 to 0.5 mm, and the thickness of the bottom portion is suitably 0.03 to 0.3 mm. It is.
When the thickness of the cylindrical portion is less than 0.1 mm, it is difficult to attach the rubber plug to the rubber plug, and it is difficult to stably mold a large amount. On the other hand, when the thickness of the tube portion exceeds 0.5 mm, the width of the guide groove of the rubber plug becomes wide, and it becomes difficult to manufacture the rubber plug as shown in FIG.
If the thickness of the bottom is less than 0.03 mm, it becomes easy to generate holes due to tearing or melting during molding such as insert injection molding. On the other hand, when the thickness of the bottom exceeds 0.3 mm, the needle stick resistance tends to increase.
Moreover, in the bottomed cylindrical synthetic resin encapsulant used in the present invention, the diameter of the cylindrical portion is not particularly limited, but 95% to 50% of the diameter of the cylindrical rubber plug is Is appropriate. If the diameter of the cylindrical portion exceeds 95%, the area of the bottom portion becomes large, so that the difficulty of forming the bottom portion having the above-described thickness increases. When the diameter is less than 50%, the needle is likely to hit the cylindrical portion when the needle pierces the rubber stopper, and the user may be confused.

Such a synthetic resin sealing body can be easily molded by an injection molding method or a thermoforming method generally used in the field of synthetic resin molding. In the thermoforming method, a film or sheet having a predetermined thickness is first formed, and then the film or sheet is heated and shaped by pressing it against a mold by vacuum / pneumatic force. In this case, the cylindrical sealing body is punched using a punching die. In the injection molding method, a cylindrical sealing body can be obtained by pressurizing and cooling a molten resin in a cylindrical mold and cooling.
Since the cylindrical sealing body in the present invention has a smaller diameter than the diameter of the rubber plug, it is not necessary to form a thin film so as to cover the entire surface of the rubber plug on the chemical liquid contact side. It is also possible to reduce the thickness of the bottom of the cylindrical sealing body on the chemical solution contact side.

The material of the synthetic resin sealing body is required to have a fusing property with the rubber plug shell support and to have a resistance to the filling chemical solution, but the former fusing property is particularly required. Polyolefin polymers such as polyethylene, polypropylene, and ethylene / vinyl acetate copolymers can be exemplified. When the latter chemical resistance is particularly required, polyester, polytetrafluoroethylene, and the like can be suitably used. When both are particularly required, a polyolefin polymer composed of a hydrocarbon such as polyethylene and polypropylene is particularly suitable.
Moreover, since the bottom of the synthetic resin sealing body tends to be easily broken when pierced with a thick needle, the density of polyethylene is 0.95 g / cm ³ or less in consideration of the softness of the synthetic resin. Are preferably ethylene homopolymers, copolymers of ethylene and other olefins, and copolymers of ethylene and vinyl acetate, and random copolymers of ethylene are preferred for polypropylene.

The mouth plug body of the present invention includes a cylindrical rubber plug and a rubber plug outer support body on which a synthetic resin sealing body as described above is mounted.
FIG. 7 shows a mouth comprising a rubber plug fitted with a synthetic resin sealing body of the shape shown in FIG. 6 (the shape in a circle is the shape shown in (A)) and a rubber plug outer support. It is a longitudinal cross-sectional view of a stopper.
In FIG. 7, the rubber plug outer support 3 is molded from the side surface of the body portion of the rubber plug 1 along the peripheral edge of the bottom of the synthetic resin sealing body 2 to form the mouth plug body 4.
The rubber plug shell support body holds the rubber plug from the side surface of the body portion, and at least the entire side surface of the top surface of the rubber plug and the peripheral edge of the bottom surface and all the side surfaces of the body portion are in close contact with the rubber plug shell support body. Are preferably in contact with each other. Further, it is preferable that the synthetic resin sealing body mounted on the rubber plug and the rubber plug outer support are fused together, and therefore, it is preferable that they are formed up to a position in contact with the rubber plug outer support.

In the embodiment shown in FIG. 7, the rubber plug shell support 3 is formed in close contact with the bottom peripheral edge of the rubber plug reaching the bottom end of the synthetic resin sealing body, and in this portion, the rubber plug shell support The body and the synthetic resin sealing body can be fused.
Furthermore, in the aspect which made the shape in the circle | round | yen in FIG. 7 the shape shown to (B), it forms in close contact over the peripheral part of the rubber plug top surface, and is formed.
As a result, the rubber plug, the rubber plug shell support body and the synthetic resin sealing body are integrated, and the mouth does not leak even when the needle for liquid injection or discharge is inserted, withdrawn or repeated. It becomes a plug.
In addition, it is preferable that the rubber plug shell support body covers the outer peripheral edge of the top surface of the rubber plug from the viewpoint of preventing the rubber plug from falling off when the needle is pulled out from the rubber plug.
Further, as will be described later, the rubber plug shell support 3 is preferably provided with an extending portion 3a extending upward as a portion that contributes to a liquid-tight seal with the plug body receiving port. ,
If the synthetic resin sealing body and the rubber plug shell support are fused, it is possible to prevent the synthetic resin sealing body from falling off.

FIG. 8 is a longitudinal cross-sectional view showing an example of a manufacturing process of a mouth member for an infusion container in which the mouth plug body 4 shown in FIG. 7 is fitted into a mouth plug body receiving port 5a provided in an upper diameter enlarged portion of the mouth member 5 of the infusion container. It is a plan view, and the stopper body receiving port 5a has a receiving part 5b at its lower end and an extended part 5c that extends upward longer than the annular convex part 3a of the rubber stopper shell support.
The elongated portion 5c, together with the annular convex portion 3a, is a portion that contributes to a liquid-tight seal between the plug body and the plug body receiving port. As shown in FIG. By pressing the melt sealer 6 against this part, the plug body and the mouth member are sealed in a liquid-tight manner at the plug body receiving port to form a mouth member for an infusion container.
The melt sealer 6 has a heater 6a, and has a recess on the side of the plug body for melting and integrating the rubber plug outer shell support and the plug body receiving port, and the recess comprises a bottom 6b and an inclined side surface 6c. According to the pressing method of the sealer, the elongated portion 5c of the plug body receptacle flows in the melted state inward, while the outer shell support annular convex portion 3a is also melted. ).

FIG. 9 is a longitudinal sectional view showing an infusion container mouth member in which a fusion-melting portion 7 is formed, in which 1 is a rubber stopper, 2 is a synthetic resin sealing body, 3 is an outer support, 5 is a mouth member, 5a is a plug body receiving port, 5b is a receiving portion, and 7 is a fused portion.
A mouthpiece for an infusion container according to the present invention comprises a rubber stopper provided with a synthetic resin sealing body and a rubber stopper outer support as constituent elements, and the rubber stopper outer support is provided on the side surface of the body of the rubber stopper. If the flange is formed in the opening of the synthetic resin infusion container main body, it is possible to connect the two. It becomes easy.

  For bonding between the two (the flange of the rubber plug shell support and the flange of the synthetic resin infusion container main body opening), ultrasonic welding or other fusion methods commonly used in synthetic resin moldings can be applied. Furthermore, without extending the rubber plug shell support portion as described above, the rubber plug shell support body can be formed along the bottom edge of the synthetic resin sealing body from the side surface of the body portion of the rubber plug. In this case, the plug member is inserted into a plug member receiving portion of a mouth member formed in advance in the synthetic resin infusion body opening, and the two are fused in a liquid-tight manner by various known heat fusion means. The method can be adopted as an effective method.

The present invention also provides a method for producing a plug body in which a rubber plug shell support is formed on a rubber plug. In this method, a rubber plug is inserted in a mold in advance, and the rubber plug outer support is injection molded.
FIG. 10 shows another example of a method for producing a plug body (similar to the plug body shown in FIG. 7) according to the present invention.
A rubber plug 1 provided with a synthetic resin sealing body is inserted into an insert injection mold composed of split molds A, B, C, and D, and resin is injected from an injection gate Cc into a cavity Cb. A rubber plug shell support is formed.
A rubber plug is inserted into the mold in advance, and the top or bottom of the rubber plug is temporarily fixed to the mold surface in order to position the rubber plug. A method of sucking and fixing a rubber stopper at a predetermined position on the surface of the mold can be employed by using the vent holes Ba and Da provided in the molds B and D facing each other.
In addition, for example, a plug body can be manufactured using a method described in JP-A-8-317996.

The infusion container of the present invention comprises an infusion container mouth member and an infusion container body.
The infusion container main body is a transparent container capable of visually recognizing a filling liquid made of a synthetic resin made of polyethylene, polypropylene or the like, and examples thereof include an infusion bottle and an infusion bag. In the case of an infusion bag, an infusion container mouth member is fused to the container body opening. The infusion container mouth member is provided with the above-described infusion container mouth plug.

It is a longitudinal cross-sectional view which shows 1 aspect of the rubber plug of the state equipped with the synthetic resin sealing body. It is a perspective view of the synthetic resin sealing body in FIG. It is a longitudinal cross-sectional view which shows 1 aspect of the rubber stopper of the state with which the synthetic resin sealing body which provided the projection part in the cylinder part was mounted | worn. It is a longitudinal cross-sectional view which shows 1 aspect of the rubber stopper provided with the guide groove. It is a longitudinal cross-sectional view which shows the example of the synthetic resin sealing bodies used for the rubber stopper shown in FIG. It is a longitudinal cross-sectional view which shows the state which mounted | wore the rubber plug shown in FIG. 4 with the synthetic resin sealing body shown in FIG. It is a longitudinal cross-sectional view which shows 1 aspect of the mouth plug body which consists of a rubber stopper and outer shell support body which mount | weared with the synthetic resin sealing body. It is the longitudinal cross-sectional view of the state which inserted the plug body of Drawing 7 in the opening of the mouth member of an infusion container, and has arranged the sealer. It is a longitudinal cross-sectional view of the mouthpiece for infusion containers which melted and integrated the plug body by the method shown in FIG. It is a longitudinal cross-sectional view which shows one example of the insert injection molding apparatus for manufacturing the plug body of this invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 ... Rubber stopper 1a ... Rubber stopper top surface 1b ... Rubber stopper bottom face 1c ... Rubber stopper trunk side 1d ... Rubber stopper trunk protrusion 1e ... Guide groove 2 ... Synthetic resin sealing body 2a ... Synthetic resin sealing body Cylindrical part 2b ... Synthetic resin sealing body bottom 2c ... Synthetic resin sealing body projection 3 ... Rubber plug shell support 3a ... Annular projection 4 ... Mouth plug 5 ... Mouth member 5a ... Mouth plug receptacle 5b ... Receiving part 5c ... elongating part 6 ... melting sealer 6a ... melting sealer heater 6b ... melting sealer recess bottom surface 6c ... melting sealer recessing side surface 7 ... melting part A, B, C, D ... cutting mold Cb ... cavity Cc ... injection gate Ba , Da ... vent hole

Claims (8)

In a mouth plug body having a cylindrical rubber stopper and a rubber stopper outer support that is attached to the opening of a synthetic resin infusion container body, the rubber stopper extends in the thickness direction with a diameter smaller than the outer diameter of the rubber stopper on the bottom surface. It has a cylindrical guide groove, and a synthetic resin sealing body with a bottomed cylindrical shape is inserted into the guide groove on the side of the chemical contact portion on the bottom surface of the rubber stopper. A mouthpiece for an infusion container characterized by being mounted. A protruding portion is provided on the cylindrical portion of the synthetic resin sealing body, and a locking portion is provided at a portion in contact with the protruding portion inside the rubber plug, and the locking portion and the protruding portion are fitted. The mouthpiece for an infusion container according to claim 1. 3. The mouthpiece for an infusion container according to claim 1, wherein the rubber stopper has a protruding portion having a diameter larger than the diameter of the top surface and the bottom surface at the center of the side surface of the trunk portion. The synthetic resin sealing body and the rubber plug shell support are fused at the cylindrical portion of the synthetic resin sealing body and / or at the peripheral end of the bottom portion. A mouthpiece for an infusion container according to 1. The mouth plug body for an infusion container according to any one of claims 1 to 4, wherein the rubber plug shell support body covers the peripheral edge of the top surface of the rubber plug. A method for producing a mouthpiece for an infusion container according to any one of claims 1 to 5, wherein a rubber stopper fitted with a synthetic resin sealing body is placed in a mold, and then a synthetic resin is injected. A method for producing a mouthpiece for an infusion container, which uses an insert injection molding method in which a rubber plug outer support is formed on a side surface of the rubber plug. An infusion container mouth member comprising the infusion container mouth plug according to any one of claims 1 to 5. An infusion container comprising the mouthpiece for an infusion container according to any one of claims 1 to 5.

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