JP2601192Y2 - Easy-open medical device container - Google Patents

Description

[Detailed description of the invention]

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an easily-openable medical device container for storing medical devices such as injection needles and catheters, heat-sealing the lid, sterilizing or sterilizing the lid, and easily removing the lid when used. Things.

[0002]

2. Description of the Related Art Conventionally, as shown in FIG. 2, a container formed by laminating a polyethylene resin 12 on a vinyl chloride resin sheet 11 by extrusion lamination or dry lamination to form a recess 13 by vacuum forming or pressure forming. Body 14
And an ethylene-vinyl acetate copolymer (EV
A) The medical instrument container was obtained by applying 16 and heat-sealing the lid 17 provided with the adhesive layer. Also,
It is also practiced to obtain a medical device container by heat-sealing a lid provided with an adhesive layer by applying EVA to the nonwoven fabric at a thickness of about 10 μm (dry) to a container body made of a vinyl chloride resin sheet. However, the former mainly uses polyethylene fibers as the nonwoven fabric, and the latter mainly uses cellulosic fibers.

[0003]

In any case, however, since EVA is applied to the entire surface of the non-woven fabric and the adhesive layer is provided, it takes a long time to sterilize, for example, due to poor ethylene oxide gas permeability. When ethylene oxide gas is forcibly injected, there is a problem that a seal portion between the nonwoven fabric and the container body is peeled off. Furthermore, in the case of a lid made of a nonwoven fabric mainly composed of polyethylene fibers, it is necessary to laminate the polyethylene resin also on the vinyl chloride resin sheet of the container body to maintain the peel strength, so that the price of the container body is high, Further, there is a problem that punching residue generated when the container body is formed cannot be collected, and the waste must be processed at a cost of several tens of yen / kg. As described above, at present, there is no satisfactory container for a medical device, and a solution to these problems is expected. The present invention solves the conventional problems described above,
To provide a recyclable easy-open medical device container which ensures breathability of a nonwoven fabric, shortens sterilization time, prevents breakage of a lid and a container body, and has a container body made of a single thermoplastic resin. As an issue.

[0004]

DISCLOSURE OF THE INVENTION The present invention provides a medical device container comprising an easily- openable lid and a container body, in which an easy-peelable adhesive coating and a vinyl chloride resin which have been conventionally performed on the lid side are provided. more becomes stopped laminate of a polyethylene resin which has conducted in the container body, the ethylene on one side of the vinyl chloride resins sheets that make up the container body instead - acetic acid
It provided easy peeling type adhesive layer comprising a vinyl copolymer, molding the container body by vacuum forming or pressure forming so that its surface becomes vessel inner heat lid made of Po Riechiren fibers of the nonwoven fabric in the flange portion An object of the present invention is to provide an easily-openable medical device container which is sealed.

[0005] A polyethylene nonwoven fabric is used for the lid of the present invention.
Used. In addition, cellulose-based, polypropylene-based,
A fiber such as a vinyl chloride resin or a nonwoven fabric made of a mixture of these fibers is also conceivable.

As the thermoplastic resin used for the container body of the present invention , a vinyl chloride resin is used. to this
Examples include polymer blends in which two or more of vinyl chloride, polyvinyl chloride, a copolymer mainly containing vinyl chloride, a graft copolymer, and a resin mainly containing vinyl chloride are mixed. Examples of the monomer for producing a vinyl chloride-based copolymer include, for example, monomers such as vinylidene chloride, vinyl acetate, acrylic acid, or an ester thereof, methacrylic acid and an ester thereof, acrylonitrile, ethylene, and propylene. . As others
Is Po polymethyl methacrylate, polycarbonate, polystyrene, acrylonitrile - styrene copolymer, methyl methacrylate - styrene copolymers, poly diethylene glycol bis allyl carbonate, ABS resins, rubber-reinforced methacrylic resin, cellulose acetate, cellulose acetate butyrate, polyvinyl chloride Resins, polyethylene, polypropylene, amorphous polyethylene terephthalate, etc. are conceivable. Furthermore, other resins to be mixed used vinyl chloride resin as a polymer blend also tentatively considered, if e example ethylene - vinyl acetate copolymer, ABS resin, NBR, MBS resins and chlorinated polyethylene or the like may be exemplified .

[0007] The vinyl chloride resin is blended with known heat stabilizers, plasticizers, lubricants and other additives. Typical examples of the heat stabilizer for transparent blending include metal soaps such as zinc stearate and calcium stearate and organic tin compounds such as dibutyltin laurate. These can be used in combination of two or more kinds, and the amount range usually blended is conveniently used.

Examples of the plasticizer include phthalic acid esters such as dioctyl phthalate, dibutyl phthalate and butylbenzyl phthalate; phosphoric acid esters such as tricresyl phosphate and tolphenyl phosphate; epoxidized soybean oil; Epoxidized oils such as linseed oil; citrates such as acetyltrioctyl citrate and tri-n-butyl citrate; and polyester plasticizers such as polypropylene adipate. These can also be used in combination of two or more.

Examples of the lubricant include fatty acids such as stearic acid and palmitic acid, fatty acid amides such as stearic acid amide and palmitic acid amide, esters such as butyl stearate, and waxes such as polyethylene wax. Can be. Plasticizers, lubricants,
The appropriate amount of other additives is selected and used in relation to the sheet and the molding conditions for the container body.

[0010] Also, as the easily peelable adhesive resin formed on the surface of the container body, ethylene emissions - acetic acid vinyl copolymer
Is used. The easily peelable adhesive resin is a container body obtained by vacuum or pressure forming the thermoplastic resin sheet at a sealing temperature in a normal medical device packaging machine, for example, in a temperature range of 120 to 180 ° C., and the nonwoven fabric described above. Not only can be very effectively bonded and sealed, but also because it is easy to sterilize with ethylene oxide gas, etc. , and has good air permeability, so that excessive internal pressure is applied to the seal site. There is no, so you can prevent bag breakage, and
The peeling force at the time of opening is about 0.3 to 0.7 kgf / cm, and the user can easily peel off. Other
As the thing, thermoplastic polyurethane or a polymer of polyurethane and ethylenically unsaturated monomer based on this,
Acrylic esters, vinyl-based resins, rubber-based resins, etc. are conceivable.

[0011] Also, a method of forming the concave surface of the or mow easily peelable adhesive layer container body, for example, the container body molding is before the thermoplastic resin sheet vinyl chloride resin sheet
It is intended to be of laminated and integrated to one side. In the laminating method, the solution of the above-mentioned easily peelable adhesive resin is applied onto the above-mentioned thermoplastic resin sheet material and dried to form an easily peelable adhesive layer. Also, a method of extruding and laminating on the sheet from a T-die of an extruder, or a film-form easily peelable adhesive resin prepared in advance by a dry laminator,
For example, a method of laminating on the sheet using an adhesive such as a urethane-based adhesive may be mentioned, but in order to be able to recycle as a single thermoplastic resin, the thickness of the easily peelable adhesive resin is generally about 10 μm. It is desirable that: Next, this laminated sheet is molded into the container body by a vacuum forming or pressure forming or the like, this time, that the peelable type adhesive layer is formed as the concave side, the medical instrument housing side in other words is important. After the medical device is stored in the container body thus formed, the above-described nonwoven fabric is placed on the upper surface of the opening as a lid, and this is placed in a medical device packaging machine and heat-sealed.

[0012] Such a container body formed by laminating a peelable type adhesive resin, for what these peelable type medical device of the present invention consisting allowed combination of the lid the adhesive component consisting of a nonwoven fabric which is not coated cloth the container is coated with a EVA in conventional nonwoven provided the adhesive layer, as compared with the combination formed by laminating a polyethylene resin in the container body inwardly, inexpensive, and et al. can breathability of the nonwoven fabric is significantly better , reduces the sterilization time, no less is more excessive internal pressure, without breakage in the sheet Lumpur sites, also deer, to the easy take out a medical instrument, and the container body, and forming the container body, hitting The ears that have been pulled out can also be recycled as a single thermoplastic resin, which is excellent in terms of environmental protection.

[0013]

The present invention will be described in more detail with reference to the following examples. Example 1 As shown in FIG. 1, an easily peelable adhesive (Sumitomo Chemical Co., Ltd.) was applied to one surface of a 0.50 mm thick vinyl chloride resin sheet (thermoplastic resin sheet) 1 obtained by a known calendering method. Aqueous dispersion of ethylene-vinyl chloride copolymer SE-1210)
Is applied with a known gravure coater, and then at 80 ° C. for 30 minutes.
After drying for 2 seconds, a vinyl chloride resin sheet having an easily peelable adhesive layer 2 having a thickness of 2 μm was obtained. This sheet is formed by a known vacuum forming machine, and the easily peelable adhesive layer 2 has a length of 100 m.
A container main body 5 having a flange 4 with a width of 5 mm on the side of the concave portion 3 having a width of 40 mm and a width of 40 mm and a depth of 40 mm was obtained. An injection needle is placed in the container body 5 and a basis weight of about 50 g / m ² , a length of 120 mm and a width of 60 mm is placed thereon.
The lid 6 made of Tyvek (Dupont polyethylene-based non-woven fabric) is placed on the medical device packaging machine.
Pressure was applied at 6 ° C. and 6 kg / cm ² for 6 seconds to obtain an easily-openable medical device container. Ethylene oxide gas was injected into this container, and gas sterilization was performed. As a result, no bag breakage at the seal portion was observed. Also, since the lid could be easily peeled off, it was very easy to take out the injection needle inside.

Example 2 An easily peelable adhesive (aqueous solution of ethylene-vinyl acetate copolymer manufactured by Toyo Ink Co., Ltd.) was applied to one side of a 0.50 mm thick vinyl chloride resin sheet obtained by a known calendering method. The dispersion (Aqua seal 566) was applied using a known gravure coater, and then dried at 80 ° C. for 30 seconds to obtain a vinyl chloride resin sheet having a 2 μm-thick and easily peelable adhesive layer. This sheet is formed by a known vacuum forming machine, and the easily peelable adhesive layer is on the concave side of 100 mm in length, 40 mm in width and 40 mm in depth,
A container body having a 5 mm wide flange portion was obtained. A syringe needle is placed in this container body, and the basis weight is about 100 g / m ² ,
A lid made of Luxer (Asahi Kasei's polypropylene-based nonwoven fabric) with a width of 60 mm and a width of 60 mm
Pressure was applied for 8 seconds under the conditions of 70 ° C. and 6 kg / cm ² to obtain an easily peelable medical device container. When ethylene oxide gas was injected into the container and gas sterilization was performed, no bag breakage at the seal portion was observed. In addition, the lid was peeled off, and the injection needle inside could be easily taken out.

Comparative Example 1 A 50% thick 3% EVA blended polyethylene film obtained by a known T-die extrusion method was coated on a 0.5 mm thick vinyl chloride resin sheet obtained by a known calendering method. Urethane adhesive (A-301: A manufactured by Takeda Pharmaceutical Co., Ltd.)
-3 = 12: 1 mixture) After dry lamination using about 5 μm, it was molded by a known vacuum molding machine, and the polyethylene layer was on the side of the concave portion having a length of 100 mm, a width of 40 mm, a depth of 40 mm, and a width of 5 mm. A container body having a flange portion was obtained. As a lid,
Easy release adhesive (Aqueouseal 566, an aqueous dispersion of ethylene-vinyl acetate copolymer manufactured by Toyo Ink Manufacturing Co., Ltd.) on one side of Tyvek (Dupont polyethylene-based nonwoven fabric) with a basis weight of about 50 g / m ² , length 120 mm and width 60 mm With a bar coater,
Then, drying was performed at 80 ° C. for 30 seconds to obtain a nonwoven fabric having a 2 μm-thick easily peelable adhesive layer. Put needle to the container body, easy peeling type adhesive layer is placed a non-woven fabric so that the container body thereon, with medical devices known in the packaging machine, 140 ℃, 6kg / cm ²
Under the conditions described above for 6 seconds to obtain a medical device container. When ethylene oxide gas was injected into this container and gas sterilization was performed, a slight breakage of the bag was observed at the seal portion. Also, after molding the container body, a request was made to a collector collecting the vinyl chloride resin sheet for the punched ears, and the collection was refused because the product was a laminate, and was disposed of as industrial waste.

(Comparative Example 2) A 0.5 mm thick vinyl chloride resin sheet obtained by a known calendering method was formed by a known vacuum forming machine, and the concave portion was 100 mm long, 40 mm wide and 40 mm deep. A container body having a flange portion with a width of 5 mm was obtained. As a lid, about 50g /
m ^2, vertical 120 mm, the lateral 60mm Tyvek peelable adhesive on one surface of (DuPont polyethylene nonwoven fabric) - a (manufactured by Toyo Ink Mfg. Co. ethylene aqueous dispersion Akuwashiru 566 vinyl acetate copolymer) was coated with a bar coater Then at 80 ° C
After drying for 30 seconds, a nonwoven fabric having a 2 μm-thick easily peelable adhesive layer was obtained. The injection needle is placed in the container body, and the nonwoven fabric is placed on the container so that the easily peelable adhesive layer is on the container side, and is pressurized at 140 ° C. and 6 kg / cm ² for 6 seconds using a known medical device packaging machine. Thus, a medical device container was obtained. Ethylene oxide gas was injected into this container, and the container was sterilized by gas. Examples 1 and 2 and Comparative Example 1,
Table 1 shows various characteristics of the medical device container obtained in 2.

[0017]

[Table 1]

[0018]

As is clear from the above examples and comparative examples, the easily-openable medical device container of the present invention has the following excellent operational effects. In the case of a lid in which a conventional nonwoven fabric is coated with an adhesive, the amount applied is limited in order to ensure a certain degree of air permeability. Therefore, the container of the present invention has a problem that the nonwoven fabric of the lid is different from the problem that the container breaks as the internal pressure of the container increases during ethylene oxide gas sterilization due to poor air permeability and weak sealing strength. Is not performed, so that not only the air permeability is good and the time for gas sterilization is shortened, but also the breakage of the bag can be prevented because the increase in the internal pressure is small. In contrast to the conventional nonwoven fabric coated with adhesive, there was a problem in productivity such as the impression cylinder roll and guide roll being stained with the adhesive.In contrast, in the present invention, the thermoplastic resin sheet is coated with adhesive. Because of that, it is excellent in productivity. Conventionally, especially in the case of large medical device containers, from the viewpoint of shape retention, when using a thick vinyl chloride resin sheet (about 0.7 to 1.0 mm) or when using a polyethylene nonwoven fabric, Since the adhesive strength alone cannot maintain the sealing strength, a polyethylene resin is laminated on a vinyl chloride resin sheet to increase the sealing strength with the nonwoven fabric. However, in the present invention, since the adhesive is coated on the vinyl chloride resin sheet, the thickness of the coating film is not particularly limited, so that the air permeability is not affected, and a good sealing strength can be obtained even when the sheet is thick. it can. Therefore, about 50
The vinyl chloride resin sheet laminated with μm polyethylene cannot be recycled as vinyl chloride resin and must be treated as industrial waste. In contrast, the container of the present invention has an easily peelable adhesive layer of several μm. , And can be recycled as a single thermoplastic resin.It is highly desirable from the viewpoint of waste disposal and environmental protection. is there.

[Brief description of the drawings]

FIG. 1 is a longitudinal sectional view of an easily-openable medical device container according to the present invention.

FIG. 2 is a longitudinal sectional view of a conventional easily-openable medical device container.

[Explanation of symbols]

DESCRIPTION OF SYMBOLS 1 ... Vinyl chloride resin sheet 11 ... Vinyl chloride resin sheet 2 ... Easy peeling type adhesive layer 12 ... Polyethylene resin 3 ... Depression 13 ... Depression 4 ... Flange part 14 ... Container body 5 ... Container body 15 ... Nonwoven fabric 6 ... Lid 16 EVA 17 Lid

Continuation of front page (56) References JP-A-1-139371 (JP, A) JP-A-51-68393 (JP, A) JP-A-49-127792 (JP, A) JP-A-3-21687 (JP, A) , A) JP-A-64-51936 (JP, A) (58) Fields investigated (Int. Cl. ⁶ , DB name) A61B 19/02 B65D 77/20

Claims (1)

(57) [Scope of request for utility model registration] 1. An ethylene-vinyl acetate copolymer on one side
A vinyl chloride-based resin sheet provided with an easily peelable adhesive layer formed by heat-sealing a lid made of a polyethylene-based non-woven fabric on a container body obtained by molding the sheet so that this surface is on the inside. A container for an easy-open medical device, characterized in that: