JP2019037663A - Seal material and container - Google Patents

Abstract

To provide a means of facilitating detecting a fact that a foreign material is mixed in a container body from a port, or a trial to mix a foreign material is performed, by punctuating a seal material of a medicine container with a needle-like article.SOLUTION: A seal material covers an opening of a container body for storing a content. The seal material includes: a sealant layer which peelably adheres to the opening; and a functional layer which is formed at a surface side opposite to a surface facing the opening of the sealant layer. In the functional layer, visible defect and/or peeling from an adjacent layer are/is generated due to puncture with a needle-like article and/or needle removal thereafter.SELECTED DRAWING: Figure 3

Description

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

  Conventionally, infusion has been widely used for the purpose of water / electrolyte replenishment, nutritional replenishment, blood vessel securing, pathological treatment and the like. The infusion solution is used by being contained in an infusion bag, and the infusion bag generally has a container body containing the infusion solution and a port for discharging the infusion solution. Inside the port, a sealing body such as a rubber stopper for preventing outflow of the infusion solution is disposed. The opening of the port is covered with a sealing material, and at least a part of the sealing material is used when the infusion bag is used. It is peeled off.

  If the infusion contains amino acids or certain antibiotics, the port must be able to protect against oxygen ingress because it is susceptible to oxygen, and infusion containing certain drugs will maintain a dissociation equilibrium Therefore, the space in the port (head space) between the sealing body and the sealing material may be replaced with nitrogen gas. Even when the infusion solution is not of a special composition, the opening of the port is usually covered with a sealing material in order to clean the inside of the port. Thus, in the infusion bag, it is necessary to keep the sealed state by covering the port with the 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 a sealed state, for example, a gas detector is arranged in the head space so that the reaction of the gas detector when the sealing property is impaired can be visually confirmed from the outside. Is known (for example, Patent Document 1).

JP 2005-349182 A

  In recent years, there have been incidents of intentional foreign body contamination from the port to the inside of the infusion bag, and there is an increasing need to easily detect foreign body contamination before prescribing the human body. .

  Therefore, the 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 body is mixed in the container body or an attempt is made to mix the foreign object, It is to provide a means for detecting facts.

  The present invention is a sealing material that covers an opening of a container main body that contains contents, and has a sealant layer that is detachably bonded to the periphery of the opening, and a surface opposite to the surface of the sealant layer that faces the opening. A functional layer formed on the surface side, and the functional layer causes a visible defect and / or peeling from an adjacent layer by puncturing with a needle-like object and / or subsequent needle removal. Provide sealing material.

  Since the sealing material of the present invention has the above-described configuration, when a foreign body is mixed into the container body by puncturing the sealing material or an attempt is made to mix the foreign material in the container whose opening is covered with the sealing material. Even in such a case, the fact can be easily detected by a visible defect in the functional layer or peeling from an adjacent layer. Note that the visible defects can be cracks and / or fragmentation.

  The opening may be formed at the other end of the outflow port for the contents whose one end is connected to the container. That is, the present invention is a sealant that covers the other end of the medicine inflow / outflow port, one end of which is connected to a container body that contains the medicine, and is a sealant layer that is peelably bonded to the other end. And a functional layer formed on the surface of the sealant layer opposite to the surface in contact with the port. The functional layer is visually recognized by puncturing with a needle-like object and / or subsequent needle removal. A sealing material is provided that causes possible defects and / or delamination from adjacent layers.

  According to the above sealing material, it is easy to puncture the sealing material of the drug container with a needle-like object or the like, even when foreign matter is mixed into the container body from the port or when an attempt is made to mix foreign matter. This fact can be detected. A person who intentionally mixes a foreign object does not puncture the container body directly, but mixes the foreign object into the container body from the port side in order to eliminate the trace of the contamination. 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, so the needle-like object is removed from the sealing material and the sealing body (with the sealing material attached to the port). The rubber stopper is pierced and penetrated, foreign matter is mixed inside the container body, and then the needle is removed. If the size of the perforation resulting from the withdrawal of the needle is small or unnoticeable, medical personnel may misunderstand that it is unused because the sealing material is still stuck, and may use it as it is. is there.

  Since the sealing material of the present invention causes a defect visible in the functional layer and peeling from an adjacent layer by puncturing with a needle-like object and subsequent needle removal, foreign matter has been mixed into the container body from the port, It becomes clear that an attempt has been made to mix in foreign matter, and it is easily visible that an abnormality has occurred.

  In the sealing material, a protective layer is provided on the surface side of the functional layer opposite to the surface in contact with the sealant layer, and the functional layer and the protective layer are punctured with a needle-like object and / or a subsequent needle removal. May cause visible defects and / or delamination from adjacent layers.

  As the functional layer, a layer that is prone to defects and delamination is used, so if it is exposed, defects and delamination will occur when it comes into contact with something other than needles that are intended to contain foreign matter. Therefore, it is possible to prevent unexpected defects and delamination by covering the functional layer with a protective layer, making sure that foreign matter has been mixed in or an attempt has been made to mix in foreign matter. Can be detected.

  Peeling can be configured to occur between the sealant layer and the functional layer. When the sealing material has only the sealant layer and the functional layer, peeling occurs between the two layers. However, when the sealing material has a protective layer in addition to these layers, peeling occurs between the sealant layer and the functional layer. Or may occur between the functional layer and the protective layer, or these may occur simultaneously. However, in order to use the protective layer to prevent unexpected defects and delamination in the functional layer as described above, it occurs between the sealant layer and the functional layer rather than peeling between these layers. It is preferable to make it.

  Peeling can occur in part or all of the peeled layer. When the sealing material is composed of only the sealant layer and the functional layer, the lamination strength between the layers can be adjusted so that the entire functional layer is peeled off by puncturing with a needle-like material and subsequent needle removal. In addition, only a part of the functional layer can be peeled off, for example, by partially changing the interlayer strength. In the case where the sealing material has a sealant layer, a functional layer, and a protective layer, only the protective layer is peeled off partly or entirely, or two layers of the functional layer and the protective layer are peeled together. In the latter case, the entire two layers of the functional layer and the protective layer may be peeled off, or only a part of the two layers of the functional layer and the protective layer may be peeled off.

  In the sealing material, a cut or perforation is formed in the functional layer and / or the protective layer, and it is preferable that visible defects and / or separation from adjacent layers occur along this cut or perforation. . When a cut is made in the functional layer or the protective layer, or perforations (continuous pores) are formed in the functional layer, puncture with a needle-like object or subsequent needle extraction easily causes cracks or fragmentation along these. In other words, it is more reliable to detect that a foreign substance has been mixed in and that an attempt has been made to mix the foreign substance.

  In addition to the sealing material described above, the present invention also provides a container. That is, this invention is a container which coat | covered the opening part of the container main body which accommodates the content with a sealing material, Comprising: The said sealing material provides the container which is the seal | sticker mentioned above. The present invention is also a container comprising a container main body that contains a medicine as a content, and a port that is connected to one end of the container main body to allow the medicine to flow in and out, and the other end of the port is the sealing material described above. A container (corresponding to a “medicine container”) coated with is provided.

  That is, the sealing material of the present invention can also be applied to seal the opening of drug containers such as vials and food containers such as jelly, tofu, instant coffee bottles, supplement bottles and the like.

  Since these containers are covered with the sealing material of the present invention, when a foreign substance is mixed into the container body from the opening or when an attempt is made to mix a foreign substance, layer defects or delamination may occur. Since this 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 a foreign substance, the fact is easily confirmed. A detectable means can be provided.

It is a top view of the medicine container of a 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 the needle was performed from the port. It is sectional drawing which shows the place where the needle extraction was performed from the sealing material of 1st Embodiment. (A) is a top view of a sealing material provided with a cut, (b) is a sectional view when a cut is provided so as not to penetrate the layer, and (c) is a cross section when a cut is provided so as to penetrate the layer. FIG. It is sectional drawing which shows the place where the needle extraction was performed from 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 needle extraction was performed from the sealing material of 3rd Embodiment. It is a top view of the chemical | medical agent 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 descriptions are omitted. In addition, the dimensional ratio in each drawing does not necessarily match the actual dimensional ratio.

  FIG. 1 is a top view of a container (corresponding to the drug container of the first embodiment as described later) including a container body and a port covered with a sealing material, and FIG. 2 is indicated by A in FIG. FIG. A drug container 30 shown in FIG. 1 includes a container main body 34 that contains a drug 32, a port 20 having one end connected to the container main body 34, and a sealing material 1 that covers the other end of the port 20. The port 20 includes a cylindrical portion 22 and a mouth portion 24, and a sealing body 26 for preventing the medicine 32 from flowing out is disposed inside the port 20 as shown in FIG.

  FIG. 3 is a cross-sectional view of the sealing material of the first embodiment. 3 includes a sealant layer 16 that is detachably bonded to the other end of the port 20, and a functional layer 17 formed on a surface opposite to the surface facing the port 20 of the sealant layer 16. have. The sealant layer 16 and the functional layer 17 are preferably bonded with a weak seal (weak adhesive strength), and an adhesive layer made of an adhesive or a pressure-sensitive adhesive for weak sealing is provided between the layers. May be.

  FIG. 4 is a cross-sectional view showing a state where puncture with a needle is performed from the port 20. In FIG. 4, the foreign material 42 is introduced into the inside of the syringe 40 composed of the syringe main body 44 and the needle 46, and the foreign material 42 is mixed using this. The needle 46 passes through the sealing body 26, the sealant layer 16, and the functional layer 17, and foreign matter 42 is mixed inside the container body 34. When the needle 46 punctures the sealing material 1, a partial pressure is applied on the plane of the sealing material 1, thereby generating a stress in the sealing material 1, and the functional layer 17 is caused by the planar stress of the sealing material 1. Peeling occurs when the piece is broken and the stress in the cross-sectional direction of the sealing material 1 exceeds the strength of the weak seal. The fragmented functional layer 17 remains on the sealant layer 16 even after the needle 46 is removed, or is removed from the sealant layer 16 according to the needle removal. Since such a situation can be visually recognized after the needle is removed, it can be detected that foreign matter is mixed.

  FIG. 5 is a cross-sectional view showing a state where the functional layer has been peeled off during the needle extraction. In FIG. 5, the needle 46 passes through the sealing body 26, the sealant layer 16 and the functional layer 17, and after the foreign substance 42 is introduced into the container body 34, the needle is removed. As the needle 46 is removed, the functional layer 17 that has been fragmented is peeled off from the sealant layer 16 and attached to the needle 46 and removed. Since the removal of the small functional layer 17 from the sealing material 1 can be visually recognized after the needle is removed, it can be easily detected that foreign matter is mixed. Even when the functional layer 17 fragmented after the needle removal is not peeled off or removed, cracks or fragmentation occurring in the functional layer can be visually recognized, and it can be easily detected that foreign matter is mixed. .

  When the sealing material 1 of the first embodiment is used as shown in FIGS. 4 and 5, the functional layer 17 is provided with notches such as a lattice in the thickness direction of the layer, or perforations such as a lattice (continuous) It is preferable to provide pores. With such a structure, the functional layer 17 can be easily separated along the incision and perforation along with the puncture or removal of needles. The cuts and perforations may be provided in at least one of the functional layer 17 and the sealant layer 16.

  6A and 6B show the functional layer 17 of the sealing material 1 according to the first embodiment in which a cut is provided. FIG. 6A is a top view of the sealing material provided with the cut, and FIG. 6B does not penetrate the layer. FIG. 6C is a cross-sectional view when a cut is provided in FIG. In the sealing material shown in FIG. 6A, the functional layer 17 is provided with cuts 62 in a lattice shape. In FIG. 6A, the notch 62 is formed from the surface side (upper surface side) opposite to the surface in contact with the sealant layer 16 of the functional layer 17, but the notch 62 does not penetrate the layer from the sealant layer 16 side. May be provided. Note that a cut that does not penetrate the layer may be mixed with a cut that penetrates, and in this case, a cut provided from the upper surface side that does not penetrate the layer and a cut provided from the lower surface side that does not penetrate the layer are mixed. May be. The above also corresponds to a case where a cut is provided in the sealant layer 16.

  In FIG. 5, a part of the functional layer 17 is peeled off, but peeling may occur in the entire functional layer 17. The sealing material that peels off in the entire functional layer 17 is the sealing material of the second embodiment. The sealing material includes the sealant layer 16 and the functional layer 17 that is laminated to the sealant layer 16 so as to be peeled as a whole. Consists of FIG. 7 is a cross-sectional view showing a place where the entire functional layer 17 is peeled off in the sealing material of the second embodiment. In FIG. 7, the needle 46 is extracted after the foreign matter 42 is mixed into the container body 34 by the needle 46 penetrating the sealing body 26, the sealant layer 16, and the functional layer 17. In this case, puncture and removal of the seal material 1 with the needle 46 cause separation between the sealant layer 16 and the functional layer 17, and the whole is removed from the sealant layer 16 according to the removal of the needle. Since such a situation can be visually recognized after the needle is removed, it can be detected that foreign matter is mixed. In the sealing material of the second embodiment, it is preferable that the functional layer 17 is not provided with cuts or perforations.

  FIG. 8 is a cross-sectional view of the sealing material of the third embodiment. 8 has a structure in which a sealant layer 16, a functional layer 17, and a protective layer 14 are laminated in this order, and the protective layer 14 is formed on the functional layer 17 of the first embodiment. Yes. The sealant layer 16 and the functional layer 17 are preferably bonded with a weak seal (weak adhesive strength), and the functional layer 17 and the protective layer 14 are bonded with a weak seal even if they are bonded with a weak seal (strong adhesive strength). ). Adhesion between the sealant layer 16 and the functional layer 17 is preferably realized by a method such as thermocompression bonding of films of different materials having high separation properties without using an adhesive or the like.

  In the sealing material of the third embodiment shown in FIG. 8, a cut or perforation may be formed in at least one of the sealant layer 16, the functional layer 17, and the protective layer 14. With such a structure, the functional layer 17 can be easily separated along the incision and perforation along with the puncture or removal of the needle-like object. The incision may be through the layer or not. In the latter case, the cut may be provided from the surface side (upper surface side) opposite to the surface facing the port 20 of the sealing material 1 or from the surface side (lower surface side) facing the port 20. . In the case where a cut is provided in at least one of the sealant layer 16, the functional layer 17, and the protective layer 14, the cut may be a mixture of what penetrates the layer and what does not penetrate. In the case of not penetrating the layers, those formed from the upper surface side and those formed from the lower surface side of each layer may be mixed.

  FIG. 9 is a cross-sectional view showing a place where the functional layer and the protective layer are peeled off during the needle extraction. In FIG. 9, the needle 46 passes through the sealing body 26, the sealant layer 16, the functional layer 17, and the protective layer 14, and after the foreign substance 42 is introduced into the container body 34, the needle is removed. Has been. As the needle 46 is removed, the functional layer 17 and the protective layer 14 that have been fragmented are separated from the sealant layer 16 and attached to the needle 46 and removed. Since the removal of the functional layer 17 and the protective layer 14 that have been cut into pieces from the sealing material 1 can be visually recognized after the needle is removed, it can be easily detected that foreign matter has been mixed.

  In the sealing material 1 of the first and second embodiments, the sealant layer 16 can be formed of a polymer material such as polyolefin such as polyethylene or polypropylene, and the functional layer 17 can be formed of, for example, cellulose, paper, or polyethylene. It can be formed of terephthalate, nylon, polypropylene or the like.

  In the sealing material 1 of the third embodiment, the sealant layer 16 can be formed of, for example, a polymer material such as polyolefin such as polyethylene or polypropylene. For example, when polyethylene is used for the sealant layer, the functional layer 17 may be selected from nylon, cyclic polyolefin, methylpentene polymer, polyethylene terephthalate, etc., which are bonded to polyethylene by thermocompression bonding and have a high separation property. The protective layer 14 can be formed of, for example, a polymer material such as polyethylene terephthalate, polybutylene terephthalate, polypropylene, and nylon. The protective layer 14 may be a single layer or a laminate composed of a plurality of layers.

  The sealing material of 1st and 2nd embodiment can be manufactured by well-known techniques, such as manufacturing each layer which comprises a sealing material separately, and bonding together through an adhesive bond layer.

  The seal material of the third embodiment can be manufactured by co-extrusion of the material of the sealant layer and the material of the functional layer, and each layer constituting the seal material is manufactured individually and the whole is thermally laminated. It can also be manufactured by a known technique such as

  A drug container can be provided using the sealing material described above. FIG. 1 is a top view showing such a drug container. A drug container 30 according to the first embodiment shown in FIG. 1 includes a container main body 34 for storing a drug 32, and a port 20 having one end connected to the container main body 34 and allowing the drug 32 to flow in and out. The other end of the port 20 is And the sealing material 1 of the embodiment. The port 20 includes a sealing body 26 for preventing the medicine 32 from flowing out. The drug container 30 of the first embodiment corresponds to a single-chamber bag because there is one container (medicine container) that stores the drug 32.

  FIG. 10 is a top view showing the container (drug container 30) of the second embodiment. The medicine container 30 shown in FIG. 10 has two accommodation parts (drug accommodation parts) for accommodating medicines, that is, the first medicine 32a is separated from the port 20 in the first medicine accommodation part on the port 20 side. Except for storing the second drug 32b in the second drug container on the side, it has the same configuration as the drug container of the first embodiment. The first drug container and the second drug container are partitioned by a weak seal portion 36 having easy peelability, and the weak seal portion 36 is peeled immediately before the drug container 30 is used, so that the first drug is separated. 32a and the second medicine 32b are mixed. Note that the sealing material 1 of the embodiment can be applied even if the medicine container has three or more.

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

  The container body 34 can be composed of a polymer film having excellent heat resistance, sealing strength, transparency, moisture permeability, flexibility, etc., and this polymer film may be a laminate for improving the performance. . Examples of the polymer used in the polymer film include olefin homopolymers or copolymers, copolymers of olefin and a compound having an ethylenically unsaturated bond other than olefin, and compounds having an ethylenically unsaturated bond other than olefin. A homopolymer or a copolymer may be mentioned. As an example of the olefin copolymer, there is an ethylene / α-olefin copolymer, and the container body 34 may be configured by a laminate in which a plurality of ethylene / α-olefin copolymers having different densities are stacked. .

  The port 20 includes a mouth portion 24, a tubular portion 22 fitted into one end of the mouth portion 24, and a sealing body 26 that is disposed in close contact with the inside of the tubular portion 22 and prevents the medicine 32 from flowing out. The The other end of the mouth 24 is covered with the sealing material 1 so as to cover the opening. The cylindrical portion 22 is bonded (tightly bonded) to the container main body 34 without a gap, but the members constituting the cylindrical portion 22 and the innermost layer constituting the container main body 34 are made of the same resin and are closely bonded by heat sealing or the like. It is preferable to do.

  The port 20 can be manufactured by inserting the sealing body 26 into the upper portion of the cylindrical portion 22 and then pressing and fitting the mouth portion 24 against the sealing body 26 using a heated jig. Moreover, adhesion | attachment to the opening part 24 of the sealing material 1 is realizable by adhesion | attachment by heat sealing or adhesive application.

  As a manufacturing method of the medicine container 30 of the first embodiment, there are the following methods. That is, for a set of polymer films constituting the container body 34, the peripheral portions of the three sides other than the side where the port 20 is inserted are heat-sealed. Subsequently, after inserting the cylindrical part 22 in the location which is not heat-sealed, the cylindrical part 22 and a polymer film are heat-sealed and it adheres without a gap. After filling the inside of the container body 34 with the medicine 32 through the cylindrical portion 22 and inserting the sealing body 26 into the upper portion of the cylindrical portion 22, the mouth 24 is made 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 bonded by applying an adhesive.

  Other manufacturing methods for the drug container 30 of the first embodiment include the following methods. That is, the cylindrical portion 22 is sandwiched between a pair of polymer films constituting the container main body 34 and bonded without a gap by heat sealing. Subsequently, after inserting the sealing body 26 into the upper part of the cylindrical part 22, the opening part 24 is pressed and fitted with respect to the sealing body 26 using the heated jig | tool, and the sealing material 1 is attached to the opening part 24. Heat seal or adhere with adhesive. At the same time or after this, the peripheral portions of the remaining three sides are heat-sealed, leaving one side where the port 20 is not inserted. The medicine 32 is filled into the container body 34 from one side that is not heat-sealed, and then this side is heat-sealed.

  Since the medicine container 30 of the embodiment covers the port 20 with the sealing material 1, when a foreign substance is mixed into the container main body 34 from the port 20 or when an attempt to mix the foreign substance is made, the functional layer Therefore, the medicine container 30 in which foreign matter is mixed or attempted to be mixed is not mistakenly used as a normal product.

DESCRIPTION OF SYMBOLS 1 ... Sealing material, 14 ... Protective layer, 16 ... Sealant layer, 17 ... Functional layer, 20 ... Port, 22 ... Cylindrical part, 24 ... Mouth part, 26 ... Sealing body, 30 ... Drug container, 32 ... Drug, 32a ... 1st chemical | medical agent, 32b ... 2nd chemical | medical agent, 34 ... Container main body, 36 ... Weak seal part, 40 ... Syringe, 42 ... Foreign substance, 44 ... Syringe main body, 46 ... Needle, 62 ... Cutting.

Claims (10)

A sealing material that covers the opening of the container body that contains the contents,
A sealant layer that peelably adheres to the periphery of the opening, and a functional layer formed on the surface of the sealant layer opposite to the surface facing the opening,
The functional layer is a sealing material that causes a visible defect and / or peeling from an adjacent layer by puncture with a needle-like object and / or subsequent needle removal.   The sealing material according to claim 1, wherein the opening is formed at the other end of the outflow port for the contents whose one end is connected to the container body. On the surface side of the functional layer opposite to the surface facing the sealant layer, a protective layer is provided,
The sealing material according to claim 1 or 2, wherein the functional layer and the protective layer cause visible defects and / or peeling from an adjacent layer by puncturing with a needle-like object and / or subsequent needle removal.   The sealing material according to any one of claims 1 to 3, wherein the visible defect is a crack and / or fragmentation.   The sealing material according to any one of claims 1 to 4, wherein the peeling occurs between the sealant layer and the functional layer.   The said peeling is a sealing material as described in any one of Claims 1-5 which arises in a part or all of the layer to peel.   The functional layer is formed with a cut or perforation, and the defect that is visible and / or the separation from an adjacent layer occurs along the cut or the perforation. The sealing material according to one item. A protective layer is provided on the surface of the functional layer opposite to the surface in contact with the sealant layer,
The functional layer and / or the protective layer are formed with cuts or perforations, and the defects that are visible and / or the separation from adjacent layers occur along the cuts or perforations. The sealing material as described in any one of 1-6. A container in which an opening of a container body for storing contents is covered with a sealing material,
The said sealing material is a container which is a sealing material as described in any one of Claims 1-8. A container comprising a container main body that contains a medicine as a content, and a port that is connected to one end of the container main body and allows the medicine to flow in and out,
The container with which the other end of the said port is coat | covered with the sealing material as described in any one of Claims 2-8.

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