JP7017771B2 - 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 functional layer formed on the surface side in which a crack or break and shrinkage (crack and shrinkage, break and shrinkage, or crack and break and shrinkage) are generated by puncture by a needle-like object.

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 some cases, the fact can be easily detected by cracking or breaking and shrinking of the functional 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. 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. And provides a sealing material comprising a functional layer formed on the surface side of the sealant layer opposite to the surface in contact with the port, which is cracked or broken and contracted by puncture by a needle-like object.

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.

The sealing material is provided with a functional layer, and when a foreign substance is mixed from a port using a needle-like object or an attempt is made to mix a foreign substance, the functional layer cracks or breaks and shrinks. It is possible to detect foreign matter contamination or its attempt.

In the sealing material, the functional layer is (1) adhered to the adjacent layer under tension on the entire surface, but (2) adheres to the adjacent layer under tension on a part of the surface. May be. In any of the cases (1) and (2), cracks or breaks and shrinkage occur based on the release of the tension. In the case of (2), the functional layer is not adhered at the position where it should be arranged inside the opening when the opening is covered with the sealing material.

Even if the functional layer is adhered to the adjacent layer with a weak seal (weak adhesive strength) on the entire surface, when a perforation occurs due to puncture by a needle-like object, the size of the perforation expands due to the tension applied to the functional layer. In addition, the shape change can be detected. When there is a non-adhesive part at the above position, when puncture by a needle-like object occurs, the non-adhesive part contracts without being restrained by the adjacent layer, so that the shape change becomes more remarkable and detection is easy. Become. When the functional layer has an adhesive portion and a non-adhesive portion with respect to the adjacent layer, the adhesive portion may be a weak seal or a strong seal (strong adhesive strength).

The layer adjacent to the functional layer can be a sealant layer. When the functional layer and the sealant layer are adjacent to each other, when the functional layer contracts due to puncture to open an opening, the sealant layer can be observed from the upper surface of the sealing material, for example, the sealant layer is colored. If so or if the sealant layer has been printed, they will be recognizable.

A protective layer may be provided on the functional layer. Since a functional layer that cracks or breaks is used, if it is exposed, it is possible that cracks or breaks will occur when it comes into contact with something other than a needle-like object for the purpose of mixing foreign matter. Therefore, by covering the functional layer with a protective layer, it is possible to prevent unexpected cracks and breakage, and it is possible to reliably detect that foreign matter has been mixed or an attempt has been made to mix foreign matter.

Further, when the functional layer is adhered to the sealant layer in a state where tension is applied, stress is generated in the thickness direction of the sealing material due to the compressive stress of the functional layer, and the entire sealing material warps toward the functional layer side. Therefore, by further adhering the protective layer to the functional layer side, the stress is offset and the warp is suppressed. By doing so, the handleability of the sealing material will be improved.

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 drug container including a container body for accommodating a drug 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 covered with the above-mentioned sealing material. It provides a drug container that is used.

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 port of this container is covered with the sealing material of the present invention, cracks or breaks occur in the functional layer when foreign matter is mixed into the container body from the port or when foreign matter is attempted to be mixed. Further, since the contraction occurs, 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 which shows the place where the puncture by a needle was performed from a port. It is a top view of the seal layer after needle removal. (A) is a top view of the seal layer before puncture, and (b) is a top view of the seal layer after needle removal. 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 includes a sealant layer 16 that is detachably adhered to the other end of the port 20, and a functional layer 17 formed on the surface side of the sealant layer opposite to the surface in contact with the port 20. ing. The functional layer 17 is adhered to the sealant layer 16 by a weak seal. The functional layer 17 is a layer in which cracks or breaks and contractions occur due to puncture by a needle-like object, and in the first embodiment, the functional layer 17 is entirely adhered to the sealant layer 16. As in the first embodiment, the sealant layer 16 and the functional layer 17 are configured to be adhered to each other on the entire surface, thereby facilitating the production of the sealing material 1 itself.

FIG. 4 is a cross-sectional view showing a place where puncture by a needle is performed from the port 20 to which the sealing material of the first embodiment is applied. 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 sealing body 26, the sealant layer 16 and the functional layer 17, and the foreign matter 42 is mixed inside the container body 34. By puncturing the sealing material 1 with the needle 46, the functional layer 17 adhered to the sealant layer 16 is cracked or broken under tension, and the functional layer 17 is also shrunk. Since the contraction of the functional layer 17 occurs from the punctured portion of the needle 46 toward the peripheral edge of the sealing material 1, a large opening is formed in the sealing material 1. Since the opening is visible, the fact that foreign matter is mixed can be easily detected.

As described above, in the sealing material of the first embodiment, the functional layer 17 is weakly sealed and adhered to the sealant layer 16 on the entire surface, but cracking or breaking and shrinkage occur without any problem due to puncture by the needle-like object. This is because a hole is made in the functional layer 17 by puncture by the needle 46, and when the needle 46 further pushes the sealant layer 16, the sealant layer 16 and the functional layer 17 are separated, and only the tensioned functional layer 17 is cracked or cracked. It causes breakage and shrinkage. That is, the strength of the weak seal referred to here must be such that the needle-like material is peeled off by the stress in the sealant 1 generated when the sealant layer 16 is pressed.

FIG. 5 is a cross-sectional view of the sealing material of the second embodiment. The sealing material 1 shown in FIG. 5 has a structure in which the sealant layer 16 and the functional layer 17 are laminated in this order. In the sealing material of the second embodiment, the functional layer 17 is partially adhered to the adjacent layer (sealant layer 16) in a state of being tensioned. That is, when the port 20 is covered with the sealing material 1, the position to be arranged inside the opening of the port 20 is not adhered, and the portion shown by X in FIG. 5 is not adhered to the adjacent layer. , The site represented by Y is adhered to the adjacent layer. As described above, in the sealing material 1 of the second embodiment, there is an unbonded portion of the functional layer 17, but for example, by using a firm and hard film as the sealant layer 16, the tension of the functional layer 17 can be withstood. Therefore, it is possible to prevent the sealing material 1 before puncturing from being deformed or the like.

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 sealant layer 16, the functional layer 17, and the protective layer 14 are laminated in this order. In the sealing material of the third embodiment, the functional layer 17 is fully adhered to the adjacent layers (sealant layer 16 and protective layer 14) in a tensioned state. By adhering the functional layer 17 to both adjacent layers in this way, the stress in the thickness direction is canceled out, and the warp of the sealing material 1 is suppressed.

FIG. 7 is a cross-sectional view showing a place where puncture by a needle is performed from the port 20 to which the sealing material of the third embodiment is applied. In FIG. 7, the needle 46 penetrates the sealing body 26, the sealant layer 16, the functional layer 17, and the protective layer 14, and the foreign matter 42 is mixed inside the container body 34. By puncturing the sealing material 1 with the needle 46, the functional layer 17 adhered to the sealant layer 16 and the protective layer 14 is cracked or broken under tension, and the functional layer 17 is also shrunk. Since the contraction of the functional layer 17 occurs from the punctured portion of the needle 46 toward the peripheral edge of the sealing material 1, a large opening is formed in the sealing material 1. Since the opening is visible, the fact that foreign matter is mixed can be easily detected.

FIG. 8 is a top view of the sealing material 1 after the needle 46 is pulled out. As described above, the functional layer 17 has an opening B due to puncture. For example, when the protective layer 14 is transparent or translucent and the sealant layer 16 is colored or printed, the sealant layer is formed. The coloring and printing of 16 can be observed from the upper surface of the sealing material 1. In the case of the second embodiment in which the adhesive region is not provided in the opening of the port, the opening B is substantially aligned with the shape of the port.

9A and 9B show a top view of the sealing material 1, where FIG. 9A is a top view of the sealing material 1 before puncture and FIG. 9B is a top view of the sealing material 1 after needle removal. FIG. 9A shows a state in which, for example, the protective layer 14 and the functional layer 17 are transparent or translucent, the sealant layer 16 is printed with P1, and the functional layer 17 is printed with P2. If the protective layer 14 is not provided, printing is performed on the functional layer 17 and the sealant layer 16, respectively. With such a configuration, P1 and P2 can be observed from the upper surface of the sealing material 1 in the positional relationship as shown in FIG. 9A. When the sealing material 1 is punctured by a needle-like object at the position Q in FIG. 9 (b), the functional layer 17 contracts and the relative positional relationship between P1 and P2 changes as shown in FIG. 9 (b). It is also possible to detect the fact that foreign matter is mixed based on this change in the positional relationship. It should be noted that this phenomenon is remarkable in the first embodiment in which the sealant layer 16 and the functional layer 17 are weakly sealed on the entire surface.

The sealant layer 16 can be formed of, for example, a polymer substance, a polyolefin such as polyethylene or polypropylene, and the functional layer 17 is a material elastically deformed by applying tension, for example, synthetic rubber, a styrene-based elastomer, or the like. Can be formed of rubber or elastomer. The protective layer 14 can be formed of, for example, a polymer material such as polyethylene terephthalate, polybutylene terephthalate, polypropylene, or nylon. The protective layer 14 may be a single layer or a laminated body composed of a plurality of layers.

The thickness of the sealant layer 16, the functional layer 17, and the protective layer 14 is arbitrary, but the sealant layer 16 can be 10 to 150 μm, the functional layer 17 can be 10 to 100 μm, and the protective layer 14 can be 10 to 100 μm, respectively. .. 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 70 to 110 μm.

The sealing materials of the first and second embodiments can be manufactured by individually manufacturing each layer constituting the sealing material and thermally laminating the whole, or by a known method such as laminating or co-extrusion. be.

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. 10 is a top view showing the container (drug container 30) of the second embodiment. The drug container 30 shown in FIG. 10 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 bonded 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 functional layer is formed when a foreign substance is mixed into the container body 34 from the port 20 or when a foreign substance is attempted to be mixed. Since the 17 is cracked or broken and shrunk, the drug container 30 to which a foreign substance is mixed or an attempt to be mixed is not misidentified as a normal product and is not used.

1 ... Sealing material, 14 ... Protective layer, 16 ... Sealant layer, 17 ... Functional 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.

Claims (7)

A sealing material that covers the opening of the container body that houses the contents.
A sealant layer that can be peelably adhered to the peripheral edge of the opening and a functional layer that is formed on the surface side of the sealant layer opposite to the surface facing the opening and that cracks or breaks and shrinks due to puncture by a needle-like object. And with
The functional layer is adhered to the sealant layer under tension.
The functional layer and the sealant layer are weakly sealed and adhered so that the functional layer can be peeled off from the sealant layer by releasing the tension.
The crack or break and shrinkage are caused by the release of the tension by the puncture and the separation of the functional layer from the sealant layer . 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 according to claim 1 or 2, wherein the functional layer is completely adhered to the sealant layer. A sealing material that covers the opening of the container body that houses the contents.
A sealant layer that can be peelably adhered to the peripheral edge of the opening and a functional layer that is formed on the surface side of the sealant layer opposite to the surface facing the opening and that cracks or breaks and shrinks due to puncture by a needle-like object. And, with
The functional layer is adhered to the sealant layer under tension.
The crack or break and shrinkage are based on the release of tension.
The functional layer is partially adhered to the sealant layer, and when the opening is covered with the sealing material, the position to be arranged inside the opening is not adhered . Le material. The sealing material according to any one of claims 1 to 4 , wherein a protective layer is provided on the functional layer. 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 drug 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.
A drug container in which the opening is formed at the other end of the port, and the other end is covered with the sealing material according to any one of claims 1 to 5 .

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