JP7144022B2 - Sealing material and container - Google Patents

Description

The present invention relates to sealing materials and containers.

Conventionally, infusions have been widely used for the purpose of supplying water and electrolytes, supplying nutrients, securing blood vessels, treating pathological conditions, and the like. The infusion solution is used by being housed 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. A seal such as a rubber plug is placed inside the port to prevent the outflow of the infusion solution. peeled off.

If the infusion fluid contains amino acids or certain antibiotics, it is susceptible to oxygen, so the port must be able to protect against oxygen ingress. Therefore, the space in the port (headspace) between the sealing body and the sealing material is sometimes replaced with nitrogen gas. Even if the infusion solution is not of a special composition, it is common to cover the opening of the port with a sealant for cleaning the port. Thus, in the infusion bag, it is necessary to keep the sealed state by covering the port with a sealing material, and it is necessary to detect from the outside when the sealed state is lost.

An example of an infusion bag that can detect the airtightness is a bag in which a gas detector is arranged in the headspace so that the reaction of the gas detector can be visually confirmed from the outside when the airtightness is compromised. is known (for example, Patent Document 1).

JP 2005-349182 A

In recent years, there have been incidents of intentional entry of foreign matter into the infusion bag from the port, and there is a growing need to be able to easily detect the presence of foreign matter before prescribing it to the human body. .

Therefore, an object of the present invention is to pierce the sealing material of the container with a needle-like object or the like, so that even if a foreign object is mixed into the container main body or an attempt is made to mix the foreign object, the container can be easily removed. To provide means capable of detecting facts.

The present invention provides a sealing material for covering an opening of a container body containing contents, comprising a sealant layer peelably adhered to the periphery of the opening, and a surface opposite to the opening of the sealant layer. a functional layer formed on the face side, wherein the functional layer exhibits visible defects and/or detachment from adjacent layers upon puncture and/or subsequent removal of the needle by a needle; Provide sealing material.

Since the sealing material of the present invention has the above-described structure, there have been cases where, with regard to a container whose opening is covered with this sealing material, foreign matter has entered the container body due to puncture of the sealing material, or attempts have been made to allow foreign matter to enter. Even if it does, this fact can be easily detected by a visible defect in the functional layer or delamination from adjacent layers. Note that the visible defects may be cracks and/or chipping.

The opening may be formed at the other end of a port for outflow of the contents, one end of which is connected to the container. That is, the present invention provides a sealing material covering the other end of the port for inflow and outflow of the drug, one end of which is connected to a container body containing the drug, the sealant layer detachably adhering to the other end. and a functional layer formed on a surface of the sealant layer opposite to the surface in contact with the port, and the functional layer is visually recognized by puncturing with a needle and/or subsequent removal of the needle. A sealing material is provided that suffers from possible defects and/or delamination from adjacent layers.

According to the sealing material described above, even if a foreign object enters the container body through the port or an attempt is made to introduce a foreign object by puncturing the sealing material of the drug container with a needle-like object, the operation can be easily performed. This fact can be detected in A person who intentionally introduces foreign matter into the container main body from the port side instead of directly puncturing the container main body in order to erase traces of the foreign matter contamination. That is, if the container body is punctured with a needle-like object such as a needle, the drug will leak out after the needle is removed. A rubber plug) is pierced to mix foreign matter into the inside of 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 mistakenly assume that the sealant is still in place and that it has not been used, and may continue to use it. be.

When the sealing material of the present invention is punctured by a needle-like object or is subsequently removed, the functional layer may have visible defects or may be peeled off from adjacent layers. It becomes clear that an attempt was made to mix foreign matter, and it is easy to visually recognize that an abnormality has occurred.

In the sealing material, a protective layer is provided on the side of the functional layer opposite to the surface in contact with the sealant layer, and the functional layer and the protective layer are used to prevent puncture by a needle and/or subsequent removal of the needle. may cause visible defects and/or delamination from adjacent layers.

The functional layer used is one that is prone to defects and delamination, so if it is exposed, defects and delamination may occur when it comes into contact with anything other than a needle-shaped object that is intended to contain foreign matter. Therefore, by covering the functional layer with a protective layer, it is possible to prevent unexpected defects and delamination, and it is possible to ensure that foreign substances have been mixed in or attempted to be mixed in. can be detected.

Delamination 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, delamination occurs between both layers, but when the sealing material has a protective layer in addition to these layers, delamination occurs between the sealant layer and the functional layer. may occur between the functional layer and the protective layer, or they may occur at the same time. However, in order for the protective layer to help prevent unintended defects and delamination in the functional layer, as described above, delamination should occur between the sealant layer and the functional layer rather than between these layers. It is preferable to let

Delamination can occur in part or all of the delamination layer. When the sealing material consists 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 object and subsequent removal of the needle. Moreover, it is also possible to make only a part of the functional layer peel off, for example, by partially differing the interlayer strength. When the sealing material has a sealant layer, a functional layer, and a protective layer, only the protective layer is partially or entirely peeled off, or 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, cuts or perforations are formed in the functional layer and/or the protective layer, and visible defects and/or peeling from adjacent layers preferably occur along the cuts or perforations. . If the functional layer or protective layer is cut or perforated (continuous pores) are formed in the functional layer, puncture with a needle-like object and subsequent removal of the needle will easily cause cracks and fragmentation along these. , and peeling off, it is possible to more reliably detect that a foreign substance has entered or that an attempt has been made to introduce a foreign substance.

In addition to the sealing material described above, the present invention also provides a container. That is, the present invention provides a container in which an opening of a container body containing contents is covered with a sealing material, wherein the sealing material is the seal described above. The present invention also provides a container comprising a container body for containing a drug as a content, and a port connected to the container body at one end for allowing the drug to flow in and out, wherein the other end of the port is the above-described sealing material. Provide a container (corresponding to a “medicine container”) coated with

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

Since the opening of these containers is covered with the sealing material of the present invention, layer defects and delamination can occur when foreign matter enters the container body through the opening or when an attempt is made to allow foreign matter to enter the container body. This fact can be easily detected visually.

According to the present invention, by piercing the sealing material of the container with a needle-like object or the like, even if a foreign object has entered the container body or an attempt has been made to introduce the foreign object, the fact can be easily detected. A detectable means can be provided.

It is a top view of the drug container of the first embodiment. 2 is a cross-sectional view of the portion indicated by A in FIG. 1; FIG. FIG. 2 is a cross-sectional view of the sealing material of the first embodiment; FIG. 11 is a cross-sectional view showing a needle puncture from a port; FIG. 4 is a cross-sectional view showing a state where a needle is removed from the sealing material of the first embodiment; (a) is a top view of a sealing material provided with a cut, (b) is a cross-sectional view when a cut is provided so as not to penetrate a layer, and (c) is a cross section when a cut is provided so as to penetrate a layer. It is a diagram. FIG. 10 is a cross-sectional view showing a state where the needle is removed from the sealing material of the second embodiment; FIG. 11 is a cross-sectional view of a sealing material according to a third embodiment; FIG. 12 is a cross-sectional view showing a state where the needle is removed from the sealing material of the third embodiment; It is a top view of the medicine container of 2nd Embodiment.

BEST MODE FOR CARRYING OUT THE INVENTION 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 overlapping descriptions are omitted. Also, the dimensional ratios in each drawing do not necessarily match the actual dimensional ratios.

FIG. 1 is a top view of a container (corresponding to the drug container of the first embodiment as described later) comprising a container body and a port covered with a sealing material, and FIG. 2 is indicated by A in FIG. FIG. 4 is a cross-sectional view of a part that is A drug container 30 shown in FIG. 1 includes a container body 34 containing a 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. As shown in FIG. 2, a sealing body 26 is arranged inside the port 20 to prevent the drug 32 from flowing out.

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 that is formed on the surface of the sealant layer 16 opposite to the surface facing the port 20. have. It is preferable that the sealant layer 16 and the functional layer 17 are adhered with a weak seal (weak adhesive strength), and an adhesive layer made of an adhesive or pressure-sensitive adhesive for weak seal is provided between the layers. may

FIG. 4 is a cross-sectional view showing a needle puncture from port 20 . FIG. 4 shows that the foreign matter 42 is introduced into the syringe 40 composed of the syringe main body 44 and the needle 46, and is used to mix the foreign matter 42 therein. 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 . When the needle 46 punctures the sealing material 1 , partial pressure is applied on the plane of the sealing material 1 , stress is generated in the sealing material 1 , and the planar stress of the sealing material 1 causes the functional layer 17 to collapse. Peeling occurs when the stress in the cross-sectional direction of the sealing material 1 exceeds the strength of the weak seal. The small pieces of the functional layer 17 remain on the sealant layer 16 even after the needle 46 is pulled out, or are removed from the sealant layer 16 as the needle is pulled out. Since such a situation can be visually recognized after the needle is removed, it is possible to detect the presence of foreign matter.

FIG. 5 is a cross-sectional view showing the peeling of the functional layer upon removal of the needle. FIG. 5 shows that the needle 46 penetrates the sealing member 26, the sealant layer 16 and the functional layer 17, and is removed after the foreign matter 42 is introduced into the container body 34. As the needle 46 is pulled out, the small pieces of the functional layer 17 are peeled off from the sealant layer 16, attached to the needle 46, and removed. Removal of the small pieces of the functional layer 17 from the sealing material 1 can be visually recognized after the needle is removed, so that it is possible to easily detect the presence of foreign matter. Even if the functional layer 17, which has been broken into small pieces, is not peeled off or removed after the needle is pulled out, cracks or small pieces generated in the functional layer are visible, and contamination with foreign matter can be easily detected. .

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 grid-like cuts in the thickness direction of the layer, or grid-like perforations (continuous perforations). Pores) are preferably provided. With such a structure, the functional layer 17 can be easily separated along the cuts and perforations when the needle is punctured or removed. Note that the cuts and perforations may be provided in at least one of the functional layer 17 and the sealant layer 16 .

FIG. 6 shows the functional layer 17 of the sealing material 1 of the first embodiment provided with cuts, (a) being a top view of the sealing material provided with the cuts, and (b) being a layer so as not to penetrate the layer. FIG. 2C is a cross-sectional view when a cut is provided in the layer, and (c) is a cross-sectional view when a cut is provided so as to penetrate the layer. In the sealing material shown in FIG. 6A, cuts 62 are provided in the functional layer 17 in a grid pattern. In FIG. 6A, the cut 62 is formed from the surface side (upper surface side) of the functional layer 17 opposite to the surface in contact with the sealant layer 16, but the cut 62 is formed from the sealant layer 16 side so as not to penetrate the layer. may be set to In addition, the cuts that do not penetrate the layer and the cuts that penetrate the layer may be mixed, and in this case, the cut that is provided from the upper surface side that does not penetrate the layer and the cut that is provided from the lower surface side that does not penetrate the layer are mixed. may Note that the above also corresponds to the case where the sealant layer 16 is provided with cuts.

Although a portion of the functional layer 17 is peeled off in FIG. 5, the entire functional layer 17 may be peeled off. The sealing material in which the entire functional layer 17 is peeled off is the sealing material of the second embodiment. consists of FIG. 7 is a cross-sectional view showing that the entire functional layer 17 is peeled off in the sealing material of the second embodiment. FIG. 7 shows a state where the needle 46 is pulled out 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. FIG. In this case, when the needle 46 punctures the sealing material 1 and removes the needle, the sealant layer 16 and the functional layer 17 are separated from each other, and the entire sealant layer 16 is removed as the needle is removed. Since such a situation can be visually recognized after the needle is removed, it is possible to detect the presence of foreign matter. In addition, in the sealing material of the second embodiment, it is preferable not to provide the functional layer 17 with cuts or perforations.

FIG. 8 is a cross-sectional view of the sealing material of the third embodiment. The sealing material 1 shown in FIG. 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. there is It is preferable that the sealant layer 16 and the functional layer 17 are adhered with a weak seal (weak adhesive strength), and the functional layer 17 and the protective layer 14 are strongly sealed (strong adhesive strength) even if they are adhered with a weak seal. ). The adhesion between the sealant layer 16 and the functional layer 17 is preferably achieved by a method such as thermocompression bonding films of different materials that are highly separated from each other without using an adhesive or the like.

In the sealing material of the third embodiment shown in FIG. 8, cuts or perforations may be formed in at least one of the sealant layer 16, the functional layer 17, and the protective layer . With such a structure, the functional layer 17 can be easily separated along the cuts and perforations as the needle is punctured or removed. The incision may or may not penetrate the layer. In the latter case, the notch may be provided from the surface side (upper surface side) of the sealing material 1 opposite to the surface facing the port 20, or from the surface side (lower surface side) facing the port 20. . In the case where at least one of the sealant layer 16, the functional layer 17 and the protective layer 14 is provided with cuts, the cuts may or may not penetrate the layer. In the case of not penetrating the layers, those formed from the upper surface side of each layer and those formed from the lower surface side may be mixed.

FIG. 9 is a cross-sectional view showing peeling of the functional layer and the protective layer upon removal of the needle. FIG. 9 shows that the needle 46 penetrates the sealing member 26, the sealant layer 16, the functional layer 17 and the protective layer 14, and is removed after the foreign matter 42 is introduced into the container body 34. It is As the needle 46 is pulled out, the small pieces of the functional layer 17 and the protective layer 14 are separated from the sealant layer 16 and attached to the needle 46 and removed. Removal of the small pieces of the functional layer 17 and the protective layer 14 from the sealing material 1 can be visually confirmed after the needle is removed, so that contamination with foreign matter can be easily detected.

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

In the sealing material 1 of the third embodiment, the sealant layer 16 can be made of, for example, a polymeric material such as polyolefin such as polyethylene or polypropylene. For example, when polyethylene is used for the sealant layer, the functional layer 17 can be selected from nylon, cyclic polyolefin, methylpentene polymer, polyethylene terephthalate, etc., which are adhered to polyethylene by thermocompression bonding and are highly separated from each other. The protective layer 14 can be made of polymeric substances such as polyethylene terephthalate, polybutylene terephthalate, polypropylene, and nylon. In addition, the protective layer 14 may be a single layer, or may be a laminate composed of a plurality of layers.

The sealing material of the first and second embodiments can be manufactured by a known technique such as manufacturing each layer constituting the sealing material individually and bonding them together via an adhesive layer or the like.

The sealing 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, or by separately manufacturing each layer constituting the sealing material and heat-laminating the whole. It can also be manufactured by known techniques 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 of the first embodiment shown in FIG. , are coated with the sealing material 1 of the embodiment. In addition, the port 20 is provided with a sealing body 26 for preventing the drug 32 from flowing out. Since the drug container 30 of the first embodiment has one storage portion (medicine storage portion) that stores the drug 32, it corresponds to a single-chamber bag.

FIG. 10 is a top view showing the container (drug container 30) of the second embodiment. The drug container 30 shown in FIG. It has the same configuration as the medicine container of the first embodiment except that the second medicine container on the side contains the second medicine 32b. The first drug containing portion and the second drug containing portion are partitioned by a weak seal portion 36 having an easily peelable property. 32a and the second drug 32b are mixed. Note that the sealing material 1 of the embodiment can be applied even when the number of medicine containing portions is three or more.

In the drug container 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 electrolytic solutions (physiological saline, Ringer's solution), glucose solutions, and amino acid solutions. , vitamin liquids, trace element liquids, and the like. The drug may be liquid or non-liquid (such as solid).

The container body 34 can be composed of a polymer film having excellent heat resistance, sealing strength, transparency, moisture impermeability, flexibility, etc., and the polymer film may be a laminate in order to improve the above performance. . Polymers used for polymer films include homopolymers or copolymers of olefins, copolymers of olefins and compounds having ethylenically unsaturated bonds other than olefins, and compounds having ethylenically unsaturated bonds other than olefins. A homopolymer or a copolymer can be mentioned. An example of the olefin copolymer is an ethylene/α-olefin copolymer, and the container body 34 can also be configured by 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 cylindrical portion 22 fitted to one end of the mouth portion 24, and a sealing body 26 that is arranged in close contact with the inside of the cylindrical portion 22 and prevents the drug 32 from flowing out. be. The other end of the mouth portion 24 is covered with the sealing material 1 so as to cover the opening. The cylindrical portion 22 is adhered (closely bonded) to the container body 34 without gaps, but the members forming the cylindrical portion 22 and the innermost layer constituting the container body 34 are made of the same resin, and are closely bonded by heat sealing or the like. preferably.

The port 20 can be manufactured by inserting the sealing body 26 into the upper part of the cylindrical part 22 and then pressing the mouth part 24 against the sealing body 26 using a heated jig to fit. Adhesion of the sealing material 1 to the opening 24 can be achieved by heat sealing or adhesive application.

Methods for manufacturing the drug container 30 of the first embodiment include the following methods. That is, for a set of polymer films constituting the container body 34, the peripheral edge portions of three sides other than the side into which the port 20 is inserted are heat-sealed. Next, after inserting the tubular portion 22 into a portion that has not been heat-sealed, the tubular portion 22 and the polymer film are heat-sealed to adhere without gaps. The inside of the container body 34 is filled with the drug 32 through the tubular portion 22, and the sealing member 26 is inserted into the upper portion of the tubular portion 22. Then, the mouth portion 24 is attached to the sealing member 26 using a heated jig. Press to fit. Next, the sealing material 1 is heat-sealed or adhered to the opening 24 by applying an adhesive.

Another manufacturing method for the drug container 30 of the first embodiment is as follows. That is, the cylindrical portion 22 is sandwiched between a set of polymer films that constitute the container body 34, and is heat-sealed without gaps. Next, after inserting the sealing body 26 into the upper part of the cylindrical part 22, the mouth part 24 is pressed against the sealing body 26 using a heated jig to fit the sealing material 1 to the mouth part 24. heat-seal or apply adhesive. 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 inside of the container body 34 is filled with the drug 32 from one side that is not heat-sealed, and then this side is heat-sealed.

In the drug container 30 of the embodiment, since the port 20 is covered with the sealing material 1, when foreign matter enters the inside of the container body 34 from the port 20 or when an attempt is made to allow foreign matter to enter, the functional layer Therefore, the drug container 30 in which a foreign substance has been mixed or has been tried to be mixed with a foreign substance is not misidentified as a normal product and used.

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... First drug, 32b... Second drug, 34... Container main body, 36... Weak seal portion, 40... Syringe, 42... Foreign matter, 44... Syringe main body, 46... Needle, 62... Notch.

Claims (7)

A sealing material covering an opening of a container body containing contents,
It has a sealant layer peelably adhered 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 cut or perforated so that it becomes a small piece by puncturing with a needle and/or subsequent removal of the needle,
The sealing material , wherein the small piece of the functional layer adheres to the needle-like object and can be peeled off from the sealant layer when the needle is removed . 2. The sealing material according to claim 1, wherein said opening is formed at the other end of said port for outflow of said contents, one end of which is connected to said container body. A protective layer formed on the surface of the functional layer opposite to the surface facing the sealant layer,
Incisions or perforations are formed in the functional layer and the protective layer so that small pieces are formed by puncturing with a needle and/or subsequent removal of the needle,
3. The sealing material according to claim 1, wherein the small piece of the functional layer laminated with the protective layer adheres to the needle-like object and can be peeled off from the sealant layer when the needle is removed. 3. The sealing material according to claim 1 , wherein the functional layer is formed with the grid-like cuts or perforations that partition the small pieces. 4. The sealing material according to claim 3 , wherein the functional layer and the protective layer are formed with the grid-like cuts or perforations for partitioning the small pieces. A container in which an opening of a container body containing contents is covered with a sealing material,
A container, wherein the sealing material is the sealing material according to any one of claims 1 to 5 . A container comprising a container body containing a drug as a content and a port connected at one end to the container body for allowing the drug to flow in and out,
An opening is formed at the other end of the port,
A container in which the other end of the port is covered with the sealing material according to any one of claims 1 to 5 .

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