JP2014005056A - Container with needle-penetrable member and manufacturing method of the same - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a container with a needle-penetrable member in which a needle-penetrable member composed of a thermoplastic synthetic resin elastic body does not directly touch medicine in the container, which is sanitary since dust or foreign matter is less likely to enter the container, and which can reduce manufacturing cost, and to provide a manufacturing method of the container with a needle-penetrable member.SOLUTION: In a container 1 with a needle-penetrable member, a needle-penetrable member 3 composed of a thermoplastic synthetic resin elastic body is fixed on at least a part of an outside surface of a container body 2 composed of blow molded soft synthetic resin. In the manufacturing method of the container 1 with a needle-penetrable member, a parison 9 composed of thermofused soft synthetic resin is inflated in a metal mold 7 to form the container body 2, and the needle-penetrable member 3 composed of the thermoplastic synthetic resin elastic body and arranged in the metal mold 7 is welded to the parison 9.

Description

  The present invention relates to a container with a needle stick member and a method for manufacturing the same, and more particularly, to a container with a needle stick member and a method for manufacturing the same.

Known as medical containers are containers called ampoules, vials, infusion bags, etc., which are equipped with a rubber stopper to pierce an injection needle or an infusion needle into the container mouth and take out the medicine in the container. As a rubber material for these rubber stoppers, vulcanized rubber has been frequently used.
However, there is a problem that the types of chemicals that can be filled in the container are limited because additives, polymerization solvents, etc. contained in the vulcanized rubber may elute into the chemicals in the container. Further, since the physical properties are different from the synthetic resin generally used as the material of the medical container, there is a problem that it cannot be recycled together with the synthetic resin container.

Therefore, a technique has been developed in which a thermoplastic synthetic resin elastic body is used as a material for the rubber plug instead of vulcanized rubber. For example, JP 2001-258991 A (Patent Document 1) and JP 2012-65830 A have been developed. The gazette (Patent Document 2) describes an invention of a plug for a drug container using a styrene-based elastomer which is a thermoplastic synthetic resin elastic body.
The plugs according to the inventions of Patent Document 1 and Patent Document 2 are used by being attached to the opening of the container. In other words, medical containers using these plugs are produced by manufacturing the container and the plug in separate steps, and then sealing the container by attaching the plug to the container. Until it is put on, it remains open, and dust and foreign matter in the air may enter the container. Furthermore, there is a problem that when dust or foreign matter adheres to the stopper, they enter the container.

  In addition, thermoplastic synthetic resin elastic bodies such as styrene elastomers constituting these plugs are less likely to elute additives contained in the elastic body into the drug in the container, compared to vulcanized rubber. However, because the additives may elute depending on the type of the drug, etc. and the storage conditions, etc., the area around the elastic body is stable against the drug, etc. There is a problem that the production cost is high because it must be coated with a highly synthetic resin film.

  Next, as a method of manufacturing a container with a needle stick member for welding a rubber stopper to a container body when a container made of a synthetic resin is blow-molded, for example, Japanese Patent Publication No. 6-51343 (Patent Document 3) includes: There is described an invention in which a stopper having a synthetic resin film made of the same material as that of the container body is disposed inside a parison in advance around a rubber stopper, and this stopper is welded to the parison during blow molding.

However, the manufacturing method according to the invention of Patent Document 3 requires a process of forming a synthetic resin film made of the same material as that of the container body around the rubber plug, and thus has a problem of high manufacturing cost.
In addition, since the stopper is disposed inside the parison, there is a problem that when dust or foreign matter adheres to the stopper, they enter the inside of the parison, that is, inside the container.
In addition, it is necessary to separately provide a mechanism having a complicated structure such as a mechanism for driving the stopper into the heated and melted parison and a mechanism for adsorbing and holding the stopper at the lower end of the die for extruding the parison. There is a problem that the manufacturing cost becomes high.

JP 2001-258991 A JP 2012-65830 A Japanese Examined Patent Publication No. 6-51343

  Therefore, the present invention has been made in view of the above problems, and a needle stick member made of a thermoplastic synthetic resin elastic body is not in direct contact with contents such as a medicine filled in a container. The purpose of the present invention is to provide a hygienic container with a needle stick member that is difficult for dust and foreign matter to enter the container, and in the manufacturing process of the container, a step of attaching a plug to the opening of the container; By eliminating the step of placing the inside of the parison, there is little danger of dust and foreign matter entering the container, and it is hygienic, providing a method for manufacturing a container with a needle stick member that simplifies the manufacturing process and reduces manufacturing costs. The purpose is to do.

  Of the present invention for solving the above-mentioned problems, the invention described in claim 1 of the present invention is characterized in that a thermoplastic synthetic resin is formed on at least a part of the outer surface of a container main body made of a blown soft synthetic resin. A needlestick member-attached container, wherein a needlestick member made of an elastic body is fixed.

  Similarly, the invention described in claim 2 is the container with a needle stick member according to claim 1, wherein the needle stick member is fixed to the lowermost part of the container body.

  Similarly, the invention described in claim 3 is the container with a needle stick member according to claim 1 or 2, wherein the contents are enclosed in the container body.

  Similarly, the invention described in claim 4 is the container with a needle stick member according to any one of claims 1 to 3, wherein a blow hole that also serves as a filling hole for contents is closed to form a sealing portion. .

  Similarly, the invention described in claim 5 is to form a container body by inflating a parison made of a soft synthetic resin that has been heated and melted in a mold, and the thermoplastic synthetic resin elastic body disposed in the mold for the parison. A method for manufacturing a container with a needle stick member, wherein a needle stick member made of

  Similarly, the invention described in claim 6 is the method for manufacturing a container with a needle stick member according to claim 5, wherein the needle stick member is arranged at the lowermost part in the mold.

According to the container with a needle stick member of the present invention, since the needle stick member made of a thermoplastic synthetic resin elastic body is fixed to the outer surface of the blow molded container body, contents such as a medicine are placed in the container body. When filled, the needle stick member does not directly touch the contents, and the additive contained in the thermoplastic synthetic resin elastic body during storage is not eluted into the contents and is hygienic.
Further, according to the container with a needle stick member of the present invention, if the blow hole formed to blow the pressure gas at the time of blow molding is also used as a filling hole for the contents in the container, Since there is no need to provide a separate filling hole in the container, dust and foreign matter can be made harder to enter the container, which is hygienic.

Furthermore, according to the method for manufacturing a container with a needlestick member of the present invention, a heated and melted parison is inflated in a mold to form a container main body, and the thermoplastic synthetic resin disposed in the mold in the parison In order to weld a needle stick member made of an elastic body, there is a risk of dust or foreign matter entering the container, such as putting a stopper on the opening of the container or placing the stopper inside the parison There is no need to provide a process. Therefore, the container with a needle stick member can be manufactured extremely hygienically, and the manufacturing process can be simplified and the manufacturing cost can be reduced.
In addition, if the needle stick member is placed at the bottom of the mold when the container body is molded, the needle stick member is unlikely to fall out of the mold or be misaligned. The needlestick member can be reliably welded to a predetermined position of the main body.

  Thus, according to the present invention, it is possible to provide a container with a needlestick member that solves the above-described problems and a method for manufacturing the same.

It is (a) side view and (b) bottom view of one embodiment of a container with a needle stick member of the present invention. It is explanatory drawing which shows the manufacturing method of the container with a needlestick member of this invention in order from (a) to (b). It is the (a) side view and (b) bottom view of one Embodiment of the needle stick member of the container with a needle stick member of this invention. It is (a) top view and (b) side view of other embodiment of the container with a needlestick member of the present invention.

  Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings. It should be noted that the present invention is not limited to these embodiments unless contrary to the spirit of the present invention.

One embodiment of the container with a needlestick member of the present invention is shown in FIGS.
A container 1 with a needle stick member includes a container main body 2 made of a soft synthetic resin that is blow-molded, and a needle stick member 3 made of a thermoplastic synthetic resin elastic body fixed to the lowermost part thereof. Is filled with liquid or powder content 6, and a blow hole used as a filling hole when the content 6 is filled into the container body 2 is heated and melted at the center of the upper surface of the container body 2. Thus, a closed sealing portion 5 is formed. In addition, a thin peelable cover film 4 for maintaining hygiene is attached to the bottom surface of the needle stick member 3.

  The container 1 with a needle stick member of the present invention has such a configuration, and the contents 6 enclosed in the container body 2 do not directly touch the needle stick member 3 of the thermoplastic synthetic resin elastic body. The additive contained in the elastic body is hygienic because there is no risk of elution into the contents 6.

In the method of using the container 1 with a needle stick member, when the content 6 is a liquid, first, the cover film 4 adhered to the bottom surface of the needle stick member 3 is peeled off, and then the needle The contents 6 are taken out by inserting an injection needle or an infusion needle into the container body 2 from the recess 3a indicating the needle stick position of the stick member 3.
If the contents 6 are powder, a predetermined amount of solvent (pure water, physiological saline, alcohol, etc.) is once injected into the container using a syringe or the like to dissolve the contents 6. The liquid 6 is then made, and then the content 6 is taken out in the same manner as in the case where the content 6 is a liquid.

  The material of the container main body 2 is a soft synthetic resin, and the degree of flexibility may be soft enough that the container wall of the container main body 2 can be easily pierced with an injection needle or an infusion needle. Examples of such soft synthetic resins include polyolefin resins such as polypropylene and polyethylene, cyclic polyolefins, polyvinyl chloride, ethylene / vinyl acetate copolymers, ionomer resins, and mixtures of two or more thereof.

In addition, when the container 1 with a needle stick member is a material that requires high performance in transparency, heat resistance, gas barrier properties, etc., such as a medical container such as an ampoule, a vial, an infusion bag, etc., the container wall A multilayer structure in which a plurality of synthetic resins having different properties are laminated may be used to improve functionality.
For example, when the synthetic resin layer of the container wall of the container body 2 has a two-layer structure, the inner layer that directly contacts the contents 6 can be a cyclic polyolefin, and the outer layer can be a polypropylene. When the synthetic resin layer has a three-layer structure, the inner layer and the outer layer can be made of polypropylene and the intermediate layer can be made of an olefin-based elastomer, or the inner layer and the outer layer can be made of polyethylene, and the intermediate layer can be made of ethylene / vinyl acetate. It can be a polymer.
In addition, the container main body 2 in this embodiment has a single-layer structure whose material is “Zeras” (registered trademark) manufactured by Mitsubishi Chemical Corporation, which is a polypropylene-based soft synthetic resin.

Next, the manufacturing method of the container 1 with a needle stick member of this invention is demonstrated, referring FIG. 2 (a) and (b).
First, as shown in FIG. 2 (a), the split molds 7a and 7b having cavities for regulating the outer surface of the container 1 with a needle stick member are opened, and are provided at the bottom of the cavity of the split mold 7b. The needle stick member 3 is placed and held in the hollow. Next, the soft synthetic resin heated and melted is injected from the die 8 to form a parison 9, which is placed between the divided molds 7a and 7b.

Then, as shown in FIG. 2 (b), the molds 7a and 7b are closed to hold the parison 9, and aseptic pressure gas is discharged from the blow hole formed in the upper part of the parison 9 by a blow nozzle (not shown). The container body 2 is formed by inflating it by blowing it into the container 9.
At that time, the outer surface of the parison 9 is brought into pressure contact with the upper surface of the needle stick member 3 disposed at the lowermost part of the cavity of the split mold 7b, and the parison 9 and the needle stick member 3 are welded and integrated, thereby The needle stick member-equipped container 1 having the needle stick member 3 fixed to the lowermost portion is formed.
As a method of inflating the parison 9 in the mold 7, the air between the parison 9 and the cavity of the mold 7 is extracted instead of or in addition to the method of blowing the pressure gas into the parison 9. It is also possible to adopt a method.

According to the manufacturing method of the container 1 with a needle stick member of the present invention described above, the container 1 in which an opening is provided in the container 1 and a stopper is attached, or the stopper is disposed inside the parison 9. Since there is no process in which dust or foreign matter may enter, it is hygienic and the manufacturing process is simple.
Furthermore, since the needle stick member 3 is arranged at the lowermost part in the split mold 7b as described above, it may fall out of the split mold 7b during the placement operation or during the movement of the split mold 7b. Misalignment is unlikely to occur, and problems such as poor welding of the needle stick member 3 to the container body 2 can be prevented.

The container 1 to which the needlestick member 3 is blow-molded has a blow hole projecting in a cylindrical shape at the top of the hollow container body 2 and is filled with a liquid or powder content 6 from the blow hole. After that, by heating and melting the periphery of the blow hole to form the sealing portion 5, the container 1 with a needle stick member in which the content 6 as shown in FIG. 1 is enclosed can be obtained.
Here, when filling the contents 1 into the container 1 at the same time or immediately after the blow molding of the container 1 (for example, blow-fill-seal method), the blow hole is closed after the contents 6 are filled. Then, the sealing part 5 may be formed. However, when there is a time difference between the blow molding and filling, such as when the container 1 is blow molded and the contents 6 are filled in different places, intrusion of dust or foreign matter from the blow hole In order to prevent this, immediately after blow molding, the blow hole is once closed to form the sealing portion 5, and then when the contents 6 are filled, the sealing portion 5 is cut off and the blow hole is opened again, and the contents are opened from there. What is necessary is just to close a blow hole again after filling the thing 6, and shape | mold the sealing part 5. FIG.

  Next, the needle stick member 3 will be described. The needle stick member 3 is made of a thermoplastic synthetic resin elastic body, and a thermoplastic elastomer such as styrene, olefin, polyurethane, polyester, polyvinyl chloride, or polybutadiene is used as the thermoplastic synthetic resin elastic body. However, it is preferable to use a styrenic thermoplastic elastomer because of the ease of needle sticking and the high resealability after withdrawal.

As the styrene-based thermoplastic elastomer, for example, a hydrogenated product of styrene / conjugated diene block copolymer is a main component, and further, a propylene-based or ethylene-based resin, a softener for hydrocarbon rubber, an inorganic filler, and the like are blended. Commercially available products include “Lavalon” (registered trademark) manufactured by Mitsubishi Chemical Corporation, “Clayton G Compound” (registered trademark) manufactured by Shell Japan, and “Sumitomo TPE” (registered trademark) manufactured by Sumitomo Chemical Co., Ltd. And “Elastomer AR” manufactured by Aron Kasei Co., Ltd., “Tough Tech Compound” (registered trademark) manufactured by Asahi Kasei Kogyo Co., Ltd., “Dynalon Alloy” (registered trademark) manufactured by Nippon Synthetic Rubber Co., Ltd., and the like.
In addition, the needle stick member 3 in this embodiment employs the above-mentioned “Rabalon” (registered trademark) manufactured by Mitsubishi Chemical Corporation as its material.

  As the hydrogenated styrene / conjugated diene block copolymer, the conjugated diene block is a polymer block composed of butadiene alone, isoprene alone, or a mixture of isoprene and butadiene, and specifically, styrene / butadiene / styrene. Examples thereof include a hydrogenated product of a block copolymer, a hydrogenated product of a styrene / isoprene / styrene block copolymer, or a hydrogenated product of a styrene / isoprene / butadiene / styrene block copolymer.

  As a method for forming the needle stick member 3, any molding method such as a compression molding method or an injection molding method can be selected. However, it is difficult to cause orientation due to resin flow during molding, and strength after molding. It is desirable to adopt a compression molding method with excellent performance stability.

Moreover, the needle stick member 3 can be colored in an arbitrary color by adding a pigment or dye for resin coloring to the raw material. If the container 1 is formed using the needle piercing member 3 colored in this way (hereinafter also referred to as “colored needle piercing member 3”), for example, depending on the type of contents to be filled in the container 1, colored needle piercing is performed. By changing the color of the member 3, it is possible to prevent a problem that a user of the container 1 causes a medical accident by using the contents by mistake.
Further, for example, if the color of the soft synthetic resin of the container body 2 is changed, it is necessary to replace all the resin raw materials into the resin extruder, which is uneconomical and laborious, but the colored needle stick member 3 In order to change, the colored needle stick member 3 having different colors is manufactured in advance, and when the container 1 is manufactured, the colored needle stick member 3 of a predetermined color is placed in the cavity of the split mold 7b. Since it only needs to be placed, it is excellent in economy and workability.

Since the needle stick member 3 is welded to the outer surface of the container body 2, the thermoplastic synthetic resin elastic body of the needle stick member 3 and the soft synthetic resin of the container body 2 are welded to be easily and firmly welded to each other. It is desirable that the materials have good compatibility.
Moreover, when the container wall of the container main body 2 has a multilayer structure, it is preferable that the welding compatibility of the synthetic resin of the outermost layer of a container wall and the synthetic resin elastic body of the needle stick member 3 is favorable.
In addition, as a synthetic resin elastic body of the synthetic resin of the container body 2 and the needle stick member 3, when materials having poor welding compatibility must be adopted, an adhesive made of a synthetic resin having good welding compatibility with both of them. A layer may be interposed. Such an adhesive layer may be layer-formed by a conventional method on the portion of the needle stick member 3 to which the container body 2 is fixed (in this embodiment, the upper surface of the needle stick member 3).

As described above, the cover film 4 that can be peeled thinly is attached to the bottom surface of the needle stick member 3 in order to maintain the hygiene of the needle stick section. It is provided and is easy to peel off when using the container 1 with a needle stick member.
As a material for the cover film 4, a resin laminated sheet mainly composed of PET, nylon or the like is generally used.

In this embodiment, the cover film 4 is adhered to the needlestick member 3 by heat sealing after the needlestick member 3 is formed, but may be performed after the container 1 with the needlestick member is formed.
Note that when the needle stick member 3 is welded to the container body 2 and placed in the split mold 7b, it is in the way that the knob portion 4a of the cover film 4 protrudes to the side of the needle stick member 3, As shown in FIGS. 3A and 3B, the knob portion 4 a is folded back by the folded portion 4 b so as to be stored on the cover film 4.

Next, another embodiment of the container with a needlestick member of the present invention will be described with reference to FIGS. 4 (a) and 4 (b).
The container 1 with a needle stick member of this embodiment has a resin coating 3a formed on the side and bottom surfaces of the needle stick member 3, and only this point is different from the container 1 shown in FIG.
The resin coating 3 a is preferably made of a synthetic resin having good welding compatibility with the needle stick member 3 and is made of the same material as the container body 2 or a material having higher flexibility than the container body 2. In the present embodiment, the resin coating 3 a is formed of a polypropylene-based soft synthetic resin (“Zerasu” (registered trademark) manufactured by Mitsubishi Chemical Corporation) made of the same material as the container body 2.
In addition, the material of the container main body 2 and the needle stick member 3 in this embodiment shown in FIG. 4 is the same as the material of the container main body 2 and the needle stick member 3 of the container 1 shown in FIG.

The resin coating 3a can be colored in an arbitrary color by adding a pigment or dye for resin coloring to the raw material. When the container 1 is formed using the needle stick member 3 having the colored resin coating 3a (hereinafter, also referred to as “colored coated needle stick member 3”), the colored needle stick member 3 is used. Similarly to the above, by changing the color of the needle-coated member 3 with a colored coating according to the type of contents to be filled in the container 1, a user of the container 1 may cause a medical accident by using the contents by mistake. Can be prevented in advance.
In addition, when the container 1 is manufactured, it is possible to easily switch to the needle coating member 3 with a colored coating having a different color, which is the same as the case where the colored needle insertion member 3 is used, which is economical and workable. Are better.

  As a method for manufacturing the needle stick member 3 coated with the resin coating 3a, various known methods can be used. For example, a resin sheet made of a raw material resin of the resin coating 3a is heated and softened, and is drawn into a die having the shape of the needle stick member 3, or pressed by a punch, and then deep-drawn and then molded. It can be manufactured by pouring the raw material resin of the needle stick member 3 heated and melted into the concave portion of the resin sheet, and compression molding and cutting into a predetermined shape.

  The present invention does not allow a needle stick member made of a thermoplastic synthetic resin elastic body to directly touch the contents filled in the container, and it is difficult for dust and foreign matter to enter the container, and the container with a hygienic needle stick member Manufacturing a container with a needlestick member that is extremely hygienic and that can reduce the manufacturing cost by minimizing the risk of dust and foreign matter entering the container in the container manufacturing process. Useful for providing a method.

DESCRIPTION OF SYMBOLS 1 Container with needle stick member 2 Container body 3 Needle stick member 4 Cover film 5 Sealing part 6 Contents 7 Mold 8 Die 9 Parison

Claims (6)

  A container with a needle stick member, characterized in that a needle stick member made of an elastic body of a thermoplastic synthetic resin is fixed to at least a part of the outer surface of a container body made of a blown soft synthetic resin.   The container with a needle stick member according to claim 1, wherein the needle stick member is fixed to the lowermost part of the container body.   The container with a needlestick member according to claim 1 or 2, wherein the contents are enclosed in the container body.   The container with a needle stick member according to any one of claims 1 to 3, wherein a blow hole serving also as a filling hole for contents is closed and a sealing portion is formed.   A parison made of heat-melted soft synthetic resin is inflated in a mold to mold a container body, and a needlestick member made of a thermoplastic synthetic resin elastic body arranged in the mold is welded to the parison. A method for producing a container with a needlestick member as a feature. 6. The method for manufacturing a container with a needle stick member according to claim 5, wherein the needle stick member is disposed at a lowermost part in the mold.