JP7017772B2 - Sealing material and container - Google Patents

Description

The present invention relates to a sealing material and a container.

Conventionally, infusion has been widely used for the purpose of supplementing water / electrolyte, supplementing nutrition, securing blood vessels, treating pathological conditions, and the like. The infusion solution is used by being housed in an infusion solution bag, and the infusion solution bag generally has a container body containing the infusion solution and a port for discharging the infusion solution. A sealant such as a rubber stopper is placed inside the port to prevent the infusion from flowing out, the opening of the port is covered with a sealing material, and at least a part of the sealing material is peeled off when the infusion bag is used. Will be done.

If the infusion contains amino acids or certain antibiotics, the port must be able to protect against the ingress of oxygen as it is susceptible to oxygen, and infusions containing certain agents maintain dissociation equilibrium. Therefore, the space in the port (head space) between the sealant and the sealant may be replaced with nitrogen gas. Even if the infusion does not have a special composition, it is common to cover the port opening with a sealant to clean the inside of the port. As described above, in the infusion bag, it is necessary to keep the port in a sealed state by covering it with a sealing material, and when the sealed state is impaired, it is necessary to detect it from the outside.

As an infusion bag capable of detecting the sealed state, for example, a gas detector is arranged in the head space so that the reaction of the gas detector when the hermeticity is impaired can be visually confirmed from the outside. Is known (for example, Patent Document 1).

Japanese Unexamined Patent Publication No. 2005-349182

In recent years, there have been cases of intentional foreign matter being mixed into the infusion bag from the port, and there is an increasing need to be able to easily detect the foreign matter being mixed before prescribing it to the human body. ..

Therefore, an object of the present invention is to puncture the sealing material of the container with a needle-like object or the like so that even if a foreign substance is mixed in the container body or an attempt is made to mix the foreign substance, the foreign substance can be easily mixed. The purpose is to provide a means for detecting facts.

The present invention is a sealing material that covers the opening of the container body that houses the contents, and is opposite to the sealant layer that detachably adheres to the peripheral edge of the opening and the surface of the sealant layer that faces the opening. Provided is a sealing material provided with a deformed layer formed on the surface side, which undergoes plastic deformation due to puncture by a needle-like object and / or subsequent needle removal.

Since the sealing material of the present invention has the above-mentioned structure, in the case where the container whose opening is covered with the sealing material is punctured by the sealing material, a foreign substance is mixed in the container body, or an attempt is made to mix the foreign substance. Even in this case, the fact can be easily detected by the plastic deformation of the deformed layer.

The opening may be formed at the other end of the port for outflow of the contents, one end of which is connected to the container body. That is, the present invention is a sealing material that covers the other end of the port for inflow and outflow of the drug, one end of which is connected to the main body of the container for accommodating the drug, and is a sealant layer that can be peelably adhered to the other end. Provided is a sealing material comprising the sealant layer and a deformed layer formed on the surface side opposite to the surface in contact with the port of the sealant layer, which causes plastic deformation due to puncture by a needle-like object and / or subsequent needle removal. ..

According to the above-mentioned sealing material, by puncturing the sealing material of the container with a needle-like object or the like, even if a foreign substance is mixed into the container body from the port or an attempt is made to mix the foreign substance, it is easy to do so. That fact can be detected. A person who intentionally mixes a foreign substance does not puncture the container body directly but mixes the foreign substance into the container body from the port side in order to erase the trace of the foreign substance mixing. That is, when the container body is punctured with a needle-like object such as a needle, the drug leaks after the needle is removed. (Rubber stopper) is pierced and penetrated, foreign matter is mixed into the container body, and then the needle is removed. If the size of the perforation resulting from needle removal is small or inconspicuous, medical personnel may misunderstand that the sealant is still affixed and therefore unused, and may use it as it is. be.

Since the sealing material of the present invention includes a deformed layer that undergoes plastic deformation due to puncture by a needle-shaped object and subsequent needle removal, when the needle-shaped object is pierced due to foreign matter contamination, the sealing material follows the shape of the needle-shaped object. Deformation occurs and its shape is fixed. In addition, the shape is fixed with respect to the deformation of the sealing material that occurs when the needle-shaped object is pulled out. Therefore, it is easy to visually recognize that an abnormality has occurred when a foreign substance is mixed into the container body from the port or when an attempt is made to mix the foreign substance.

The sealing material may have a flexible layer between the sealant layer and the deformable layer, which is more flexible than the sealant layer. With such a configuration, the flexibility of the entire sealing material is improved, and the contact of the container with the secondary outer bag such as a barrier bag prevents pinholes or the like from being generated in the sealing material. Further, by providing the flexible layer between the sealant layer and the deformable layer, the shape change due to the plastic deformation of the deformable layer is more maintained as compared with the one without the flexible layer. The flexibility of the layers can be compared by Young's modulus.

The sealing material may be provided with a protective layer covering the deformed layer. The presence of the protective layer makes it possible to give the sealing material a firmness and improve its mechanical suitability. Further, since the surface of the deformed layer is covered, it is possible to prevent the occurrence of pinholes.

The deformable layer is preferably made of metal. Since the metal has excellent plastic deformability and a clear trace of foreign matter contamination remains even after the needle is removed, it is possible to easily detect that foreign matter has been mixed or that an attempt has been made.

The present invention provides a container in addition to the sealing material described above. That is, the present invention provides a container in which the opening of the container body for accommodating the contents is covered with a sealing material, and the sealing material is the above-mentioned sealing container. The present invention is also a container including a container body for accommodating a drug as a content and a port having one end connected to the container body to allow the drug to flow in and out, and the other end of the port is a sealing material described above. Provided is a container (corresponding to a “drug container”) coated with.

The sealing material of the present invention can also be applied to seal the openings of drug containers such as vial bottles and food containers such as jelly, tofu, instant coffee bottles, and supplement bottles.

Since the opening of this container is covered with the sealing material of the present invention, the sealing material is plastically deformed and punctured when foreign matter is mixed into the container body from the opening or when an attempt is made to mix foreign matter. Since the trace remains, the fact can be easily detected visually.

According to the present invention, by puncturing the sealing material of the container with a needle-like object or the like, even if a foreign substance is mixed in the container body or an attempt is made to mix the foreign substance, the fact can be easily detected. It is possible to provide a detectable means.

It is a top view of the drug container of 1st Embodiment. It is sectional drawing of the part shown by A of FIG. It is sectional drawing of the sealing material of 1st Embodiment. It is sectional drawing which shows the place where the puncture by a needle was performed from a port. It is sectional drawing of the sealing material of 2nd Embodiment. It is sectional drawing of the sealing material of 3rd Embodiment. It is sectional drawing of the sealing material of 4th Embodiment. It is a top view of the drug container of 2nd Embodiment.

Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings. In this description, the same reference numerals are used for the same elements, and duplicate description will be omitted. Moreover, the dimensional ratio of each drawing does not always match the actual dimensional ratio.

FIG. 1 is a top view of a container having a container body and a port coated with a sealing material (corresponding to the drug container of the first embodiment as described later), and FIG. 2 is shown in FIG. 1A. It is a cross-sectional view of the part. The drug container 30 shown in FIG. 1 includes a container body 34 for accommodating the drug 32, a port 20 having one end connected to the container body 34, and a sealing material 1 covering the other end of the port 20. The port 20 is composed of a tubular portion 22 and a mouth portion 24, and as shown in FIG. 2, a sealing body 26 for preventing the outflow of the drug 32 is arranged inside the port 20.

FIG. 3 is a cross-sectional view of the sealing material of the first embodiment. The sealing material 1 shown in FIG. 3 has a sealant layer 16 that is detachably adhered to the other end of the port 20 and a deformed layer formed on the surface side of the sealant layer 16 opposite to the surface in contact with the other end of the port 20. It is equipped with 19. The deformable layer 19 undergoes plastic deformation by puncturing with a needle-like object and / or subsequently removing the needle. An adhesive layer for adhering these layers may be provided between the sealant layer 16 and the deformable layer 19.

FIG. 4 is a cross-sectional view showing a place where puncture by a needle is performed from the port 20. FIG. 4 shows that a foreign matter 42 is introduced into a syringe 40 composed of a syringe body 44 and a needle 46, and the foreign matter 42 is mixed using the foreign matter 42. The needle 46 penetrates the sealant layer 16 and the deformable layer 19, and foreign matter 42 is mixed inside the container body 34. When the needle 46 penetrates the sealing material 1, the sealant layer 16 and the deformable layer 19 are pushed by the needle 46 and deformed in the penetrating direction, but this deformation is fixed even after the needle 46 is pulled out. .. If the needle 46 is pulled out at an angle when the needle 46 is pulled out, the sealing material 1 is further plastically deformed along the direction in which the needle 46 is pulled out. Since the portion where the composition is deformed is visible, the fact that foreign matter is mixed can be easily detected.

FIG. 5 is a cross-sectional view of the sealing material of the second embodiment. The sealing material 1 shown in FIG. 5 is provided with a flexible layer 52 between the sealant layer 16 and the deformable layer 19. The flexible layer 52 gives flexibility to the entire sealing material 1. The flexible layer 52 is a layer that is more flexible than the sealant layer 16 (for example, a layer having a lower Young's modulus), and is located between the sealant layer 16 and the flexible layer 52, and between the flexible layer 52 and the deformable layer 19. An adhesive layer for adhering the layers may be provided.

FIG. 6 is a cross-sectional view of the sealing material of the third embodiment. The sealing material 1 shown in FIG. 6 has a structure in which the deformable layer 19 is laminated on the sealant layer 16 and the protective layer 14 is laminated on the deformable layer 19. The protective layer 14 imparts elasticity to the entire sealing material 1 and imparts mechanical aptitude. It also has a function of preventing the deformable layer 19 from plastically deforming or causing defects such as pinholes in the sealing material 1 when the sealing material 1 comes into contact with something other than a needle-like object for mixing foreign matter. An adhesive layer for adhering these layers may be provided between the sealant layer 16 and the deformed layer 19, and between the deformed layer 19 and the protective layer 14.

FIG. 7 is a cross-sectional view of the sealing material of the fourth embodiment. The sealing material 1 shown in FIG. 7 has a structure in which the sealant layer 16, the flexible layer 52, the deformable layer 19, and the protective layer 14 are laminated in this order. The functions of the flexible layer 52 and the protective layer 14 are as described above, and these are between the sealant layer 16 and the flexible layer 52, between the flexible layer 52 and the deformable layer 19, and between the deformable layer 19 and the protective layer 14. An adhesive layer for adhering the layers may be provided.

The sealant layer 16 can be formed of, for example, a polymer substance, for example, a polyolefin such as polyethylene or polypropylene, and the deformable layer 19 can be formed of, for example, a metal such as aluminum, paper, cellulose, a resin having shape memory, or the like. Can be formed with. The flexible layer 52 can be formed of, for example, a polyamide resin such as 6,6-nylon (registered trademark), an ethylene vinyl alcohol copolymer (EVOH), a polymer substance such as polyethylene, and the protective layer 14 can be formed of, for example. , Polyethylene terephthalate, polybutylene terephthalate, polypropylene, nylon and the like. The protective layer 14 may be a single layer or a laminated body composed of a plurality of layers. When the sealing material 1 has an adhesive layer, the adhesive layer can be formed of a urethane-based adhesive, an acrylic-based adhesive, a synthetic rubber-based adhesive, an epoxy-based adhesive, or the like.

The thickness of the sealant layer 16, the deformable layer 19, the flexible layer 52, and the protective layer 14 is arbitrary, but the sealant layer 16 is 10 to 150 μm, the deformable layer 19 is 5 to 100 μm, and the flexible layer 52 is 10. The protective layer 14 can be set to about 100 μm and 10 to 100 μm. The thickness of the entire sealing material 1 is also arbitrary, but in order to ensure the effect of the present invention, it can be, for example, 50 to 300 μm, and more preferably 50 to 110 μm. The material and thickness of the deformable layer 19 are preferably selected so as to have holdability when a needle having a diameter of 0.4 to 1.2 mm is pierced.

The sealing material of the first to fourth embodiments can be manufactured by individually manufacturing each layer constituting the sealing material and thermally laminating the whole, or by a known method.

A drug container can be provided using the sealing material described above. FIG. 1 is a top view showing such a drug container. The drug container 30 of the first embodiment shown in FIG. 1 includes a container body 34 for accommodating the drug 32 and a port 20 having one end connected to the container body 34 to allow the drug 32 to flow in and out, and the other end of the port 20 is , Is covered with the sealing material 1 of the embodiment. The port 20 is provided with a sealing body 26 inside the port 20 to prevent the outflow of the drug 32. The drug container 30 of the first embodiment corresponds to a single-chamber bag because it has one storage section (drug storage section) for storing the drug 32.

FIG. 8 is a top view showing the container (drug container 30) of the second embodiment. The drug container 30 shown in FIG. 8 has two accommodating portions (drug accommodating portions) for accommodating drugs, that is, the first drug 32a is separated from the port 20 in the first drug accommodating portion on the port 20 side. It has the same configuration as the drug container of the first embodiment except that the second drug 32b is housed in the second drug container on the side. The first drug accommodating portion and the second drug accommodating portion are partitioned by a weakly sealed portion 36 having easy peelability, and the weakly sealed portion 36 is peeled off immediately before the use of the drug container 30 to peel off the first drug. 32a and the second agent 32b are mixed. It should be noted that the sealing material 1 of the embodiment can be applied even if the drug accommodating portion is 3 or more.

In the drug container of the first and second embodiments, the drug 32, the first drug 32a, and the second drug 32b contained in the container body 34 include an electrolyte solution (physiological saline solution, Ringer's solution), a glucose solution, and an amino acid solution. , Vitamin solution, trace element solution and the like. The drug may be liquid or non-liquid (solid or the like).

The container body 34 can be made of a polymer film having excellent heat resistance, sealing strength, transparency, impermeableness, flexibility, etc., and the polymer film may be a laminated body for the above performance improvement. .. Polymers used in polymer films include olefins alone or copolymers, copolymers of olefins with compounds having ethylenically unsaturated bonds other than olefins, and compounds having ethylenically unsaturated bonds other than olefins. Examples include singles and copolymers. An example of the olefin copolymer is an ethylene / α-olefin copolymer, and it is also possible to form the container body 34 with a laminate in which a plurality of ethylene / α-olefin copolymers having different densities are laminated. ..

The port 20 is composed of a mouth portion 24, a tubular portion 22 fitted to one end of the mouth portion 24, and a sealing body 26 that is closely arranged inside the tubular portion 22 to prevent the outflow of the drug 32. To. The other end of the mouth portion 24 is covered with the sealing material 1 so as to cover the opening. The tubular portion 22 is adhered (tightly bonded) to the container body 34 without a gap, but the member constituting the tubular portion 22 and the innermost layer constituting the container body 34 are tightly bonded by heat sealing or the like, using the same resin. It is preferable to do so.

The port 20 can be manufactured by inserting the sealing body 26 into the upper part of the tubular portion 22 and then pressing the mouth portion 24 against the sealing body 26 using a heated jig to fit the port 20. Further, the sealing material 1 can be adhered to the mouth portion 24 by heat sealing or adhesion by applying an adhesive.

As a method for manufacturing the drug container 30 of the first embodiment, there are the following methods. That is, for a set of polymer films constituting the container main body 34, the peripheral edges of three sides other than the side into which the port 20 is inserted are heat-sealed. Next, after the tubular portion 22 is inserted into a portion that is not heat-sealed, the tubular portion 22 and the polymer film are heat-sealed and adhered without gaps. The drug 32 is filled inside the container body 34 through the tubular portion 22, the sealing body 26 is inserted in the upper part of the tubular portion 22, and then the mouth portion 24 is inserted into the sealing body 26 with respect to the sealing body 26 using a heated jig. Press to fit. Next, the sealing material 1 is heat-sealed to the mouth portion 24 or adhered by applying an adhesive.

As another manufacturing method of the drug container 30 of the first embodiment, there are the following methods. That is, the tubular portion 22 is sandwiched between a set of polymer films constituting the container main body 34, and is adhered without a gap by a heat seal. Next, after inserting the sealing body 26 into the upper part of the tubular portion 22, the mouth portion 24 is pressed and fitted to the sealing body 26 using a heated jig, and the sealing material 1 is fitted to the mouth portion 24. Heat seal or apply adhesive to bond. At the same time or after this, the peripheral edges of the remaining three sides are heat-sealed, leaving one side where the port 20 is not inserted. The drug 32 is filled inside the container body 34 from one side that is not heat-sealed, and then this side is heat-sealed.

Since the port 20 of the drug container 30 of the embodiment is covered with the sealing material 1, the sealing material is used when a foreign substance is mixed into the container body 34 from the port 20 or when an attempt is made to mix the foreign substance. Since the shape of 1 is fixed while being deformed, the drug container 30 in which foreign matter is mixed or attempted to be mixed is not misidentified as a normal product and used.

1 ... Sealing material, 14 ... Protective layer, 16 ... Sealant layer, 19 ... Deformed layer, 20 ... Port, 22 ... Cylindrical part, 24 ... Mouth part, 26 ... Sealed body, 30 ... Drug container, 32 ... Drug, 32a ... 1st drug, 32b ... 2nd drug, 34 ... container body, 36 ... weak seal, 40 ... syringe, 42 ... foreign matter, 44 ... syringe body, 46 ... needle, 52 ... flexible layer.

Claims (7)

A sealing material that covers the opening of the container body that houses the contents.
Plastic deformation due to puncture by a needle-like object and / or subsequent needle removal formed on the surface side of the sealant layer that is releasably adhered to the peripheral edge of the opening and the surface of the sealant layer opposite to the surface facing the opening. And the deformed layer that causes
A flexible layer that is arranged between the sealant layer and the deformed layer and is more flexible than the sealant layer.
Equipped with
The thickness of the deformed layer is 5 μm or more and 100 μm or less.
A sealing material having a flexible layer having a thickness of 10 μm or more and 100 μm or less . The sealing material according to claim 1, wherein the opening is formed at the other end of a port for outflow of the contents, one end of which is connected to the container body. The sealing material is deformable with the plastic deformation of the deformed layer, and has a thickness in which the deformed shape is fixed even after the needle-like object is removed.
The sealing material according to claim 1 or 2, wherein the thickness of the sealing material is 50 μm or more and 300 μm or less . The sealing material according to any one of claims 1 to 3, further comprising a protective layer covering the deformable layer on the deformable layer. The sealing material according to any one of claims 1 to 4, wherein the deformable layer is made of metal. A container in which the opening of the main body of the container that houses the contents is covered with a sealing material.
The sealing material is a container which is the sealing material according to any one of claims 1 to 5. A container having a container body for accommodating a drug as a content and a port having one end connected to the container body to allow the drug to flow in and out.
The other end of the port is a container covered with the sealing material according to any one of claims 2 to 5.

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