JP3346759B2 - Method of manufacturing medical container and medical container - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a method for manufacturing a medical container and a medical container manufactured by the method.
More specifically, the conventional normal high-frequency welder device was unable to generate internal heat, and was sealed by high-frequency welding using a film or sheet made of a thermoplastic resin, for removing contents. The present invention relates to a method of manufacturing a medical container having a port member and a medical container manufactured by the method.

[0002]

2. Description of the Related Art Medical containers include, for example, a "blood bag" for storing blood and blood components, a "cell culture bag" for storing living cells such as bone marrow and lymphocytes, and a "urine collection bag" for storing urine. , An infusion bag that stores drug solutions for infusion, an IVH bag that stores nutrients for direct administration to the central vein, a bag that stores enteral nutrition, and a bag that stores various drug solutions. is there. Of these, blood bags and infusion bags were used in the old days when glass containers were used, but they were soft, light,
With the advent of the so-called soft bag, which has the feature that it does not break and does not require a ventilation needle when taking out the contents liquid,
These changed rapidly.

[0003] In this soft bag, the shape of a container is formed by sealing a plastic sheet or film. In the case of a sheet made of polyvinyl chloride (PVC) or an ethylene-vinyl acetate copolymer, a high-frequency dielectric heating method is mainly used for the sealing method.

The high-frequency dielectric heat sealing method is a method in which high-frequency energy is directly applied to molecules constituting a sheet material and heat is generated from the molecular motion, compared to the heat sealing method and the impulse sealing method. Since the heat of the interface of the sheet is smaller than that of the sheet and other parts, the temperature is highest. Therefore, there are advantages such as high adhesive strength and beautifully finished seal.

[0005] In order to take advantage of the high-frequency dielectric heat sealing method, attempts have been made to obtain a necessary calorific value by mixing a polymer material or a metal material that induces internal heat generation with a material that does not internally generate heat by high frequency. For example, a method of polymer blending an ethylene-vinyl acetate copolymer or polyvinyl acetate in polyethylene has been attempted, but a sufficient calorific value can be obtained unless the weight content in terms of vinyl acetate units is about 10% or more. In addition, if the amounts are mixed, the molding temperature and the softening temperature of the material become too low, which makes the material unsuitable as a medical container.

Although a method of mixing metal powder such as iron powder in polyethylene has been attempted, visible metal powder is dispersed in a sheet, and a part of the powder is not exposed on the sheet surface. And a sufficient calorific value cannot be obtained.
For this reason, this method is also unsuitable as a sheet for medical containers.

Japanese Patent Publication No. 3-56890 discloses a method of attaching a port to a medical bag. In this method, both the sheet and the port of the medical bag are made of a material that does not generate heat internally by a high-frequency dielectric heating method. This is an external heat generation method that applies heat from the outside by sandwiching and sealing between two sheets that generate heat internally using a high frequency dielectric heating method. This method uses a high frequency oscillator, but the mechanism for sealing is heat sealing. It is a similar external heating method.

In the heat sealing method and the impulse sealing method, heat necessary for sealing is applied from the outside of the sheet to the sealing surface through the sheet to the sealing surface, so that it takes time to transfer heat energy required for melting the sheet interface required for sealing. There is a problem that it takes time to cool down after sealing, that is, the production efficiency is poor. In addition, other parts of the sheet and members to be fused must not be deformed so that the shape cannot be maintained until the sheet interface is melted. In addition, although the deformation is not enough to maintain the shape, there is a problem that the seal finish is not beautiful.

Further, the above-mentioned problem can be solved by using the high-frequency dielectric heating method. However, the material that generates internal heat by the high-frequency dielectric heating is limited to a material containing a polar group to some extent due to its molecular structure. There was a point.

[0010]

SUMMARY OF THE INVENTION An object of the present invention is to solve the above-mentioned problems, and to improve the production efficiency of a sheet or the like containing polyolefin as a main component by a high-frequency dielectric heating method and to seal it beautifully. It is another object of the present invention to provide a method for manufacturing a medical container provided with a hollow port member such as a tube mounting port member, and to provide a high-strength and beautifully bonded medical container obtained by this manufacturing method. .

[0011]

Means for Solving the Problems As a result of repeated studies to solve the above-mentioned problems, the present inventors have found that a film or a sheet mainly composed of polyolefin and a hollow film mainly composed of the same or different polyolefin are used. When the port member is bonded by high-frequency dielectric heating to produce a medical container equipped with the port member, a "mold", a "lower plate" and a "core" for sealing the port member are provided. If the film or sheet and the port member are sealed at one time using a high-frequency welder, the adhesion between the film or sheet and the port member becomes insufficient, sufficient adhesive strength cannot be obtained, and centrifugation is performed. Leakage occurs in tests and autoclave resistance tests. However, it has been found that if these are not sealed at once but are sealed in a specific order, the port member can be beautifully and firmly sealed, and a good medical container having high adhesive strength can be provided. Reached. That is, the present invention relates to <1> a method for producing a medical container made of a thermoplastic resin sheet or film provided with a port member by a high-frequency dielectric heating method, wherein (1) a mold (electrode) and a lower A sheet or film of the thermoplastic resin constituting the front and back surfaces of the medical container main body is interposed between a plate (electrode) and a core metal between the sheet or film of the thermoplastic resin.
(Electrode) is inserted between the port members, and the thermoplastic resin sheet or film is interposed between the port members, into which a metal core (electrode) is inserted, to form the mold (electrode).
Or a first application step of sequentially applying a high-frequency voltage between a lower plate (electrode) and a core metal (electrode); (2) a mold (electrode) and a lower plate
A method for manufacturing a medical container, comprising a second application step of applying a high-frequency voltage between the medical container and the (electrode). <2> The first applying step is performed by lower plate (electrode) and core metal (electrode)
Between the port member and the lower plate
The sheet or film on the (electrode) side is bonded, and then a high-frequency voltage is applied between the mold (electrode) and the core (electrode) to remove the port member and the sheet or film on the mold (electrode). <1> characterized by comprising a step of bonding.
2. The method for producing a medical container according to item 1. <3> The medical device according to <1> or <2>, wherein after the first applying step, the second applying step is performed, and a predetermined portion of the sheet or film is adhered to each other. This is a method for manufacturing a container. <4> The above <1>, wherein the thermoplastic resin sheet or film has a single-layer or multilayer structure.
A method for manufacturing a medical container according to any one of <3> to <3>. <5> The method for producing a medical container according to any one of <1> to <4>, wherein the thermoplastic resin is a halogen-free thermoplastic resin having a dielectric constant of 2.3 or more. <6> The thermoplastic resin is polyethylene, polypropylene, polybutene, polybutadiene, polyisoprene, poly-4-methylpentene-1, polystyrene, polyvinyl acetate, polymethyl methacrylate, polyethyl methacrylate, polyacrylic acid, cyclic It is a homopolymer and / or a copolymer and / or a polymer blend containing at least one of the group consisting of polyolefin, polyacrylonitrile, polyamide (nylon), polyester, polyurethane, polycarbonate, polyimide, and polyphenylene sulfide. A method for producing a medical container according to any one of <1> to <5>. <7> The method for producing a medical container according to any one of <1> to <6>, wherein the thermoplastic resin is a thermoplastic elastomer and / or a polymer blend containing the same. . <8> The copolymer is ethylene-α-olefin copolymer including ethylene-propylene copolymer, ethylene-butene copolymer, ethylene-hexene copolymer, ethylene-octene copolymer, ethylene- Vinyl acetate copolymer, saponified ethylene-vinyl acetate copolymer, ethylene-acrylic acid copolymer, ethylene-ethyl acrylate copolymer, ethylene-methyl methacrylate copolymer,
Block copolymer, polyamide comprising ethylene-maleic anhydride copolymer, ionomer, styrene and / or ethylene as a main component and butadiene and / or isoprene and / or a hydrogenated product thereof <6. The polyester according to the item <6, wherein the (6) is a (nylon) -polyether block copolymer, polyester-polyether block copolymer, polyester-polyester block copolymer, polyether-based or polyester-based, or polycarbonate-based polyurethane elastomer. > The method for producing a medical container described in <1>. <9> The thermoplastic resin is a block copolymer composed of a portion mainly composed of styrene and / or ethylene, a portion composed of butadiene and / or isoprene and / or a hydrogenated product thereof, and polypropylene and /
Or <1> to <<, characterized by comprising a polymer blend with polyethylene and / or polybutene.
8>. <10> The sheet or film has a multilayer structure, and the innermost layer of the medical container is a polyamide elastomer,
The method for producing a medical container according to any one of the items <4> to <8>, wherein the container is formed of a thermoplastic elastomer selected from a polyester elastomer and a polyurethane elastomer and / or a polymer blend containing the same. is there. <11> The medical container is a bag for storing blood and blood components, a bag for storing body fluids such as bone marrow, lymph, and urine, an infusion bag, a bag for storing nutrients for direct administration to a central vein, and the like. <1> to <1>, which is at least one of a bag for storing an intestinal nutritional supplement and a bag for storing various chemical solutions.
0>. <12> A medical container manufactured by the manufacturing method according to any one of <1> to <11>.

[0012]

DESCRIPTION OF THE PREFERRED EMBODIMENTS The thermoplastic resin in the present invention does not need to be particularly limited. Specifically, for example, polyethylene, polypropylene, polybutene, polybutadiene, polyisoprene, poly-4-methylpentene-1, polystyrene, polyvinyl acetate, polymethyl methacrylate, polyethyl methacrylate, polyacrylic acid, cyclic polyolefin, A homopolymer containing at least one of the group consisting of polyacrylonitrile, polyamide (nylon), polyester, polyurethane, polycarbonate, polyimide, and polyphenylene sulfide; and / or
Alternatively, it is preferably a copolymer and / or a polymer blend.

The copolymer includes ethylene-propylene copolymer, ethylene-butene copolymer and ethylene-propylene.
Hexene copolymer, ethylene-α-olefin copolymer including ethylene-octene copolymer, ethylene-vinyl acetate copolymer, saponified ethylene-vinyl acetate copolymer, ethylene-acrylic acid copolymer, ethylene -Ethyl acrylate copolymer, ethylene-methyl methacrylate copolymer, ethylene-maleic anhydride copolymer, ionomer, styrene and / or ethylene-based portion, and butadiene and / or isoprene and / or their components A block copolymer, a polyamide (nylon) -polyether block copolymer, a polyester-polyether block copolymer, a polyester-polyester block copolymer,
Examples thereof include polyether-based, polyester-based, and polycarbonate-based polyurethane elastomers.

The thermoplastic resin used in the present invention does not contain a halogen element as a main component and has a dielectric constant of 2.3.
As another example of the above thermoplastic resin, a blend of a thermoplastic elastomer and a polyolefin can be preferably used. Specific examples of polyethylene include low-density polyethylene (LDPE), high-density polyethylene (HDPE), and linear low-density polyethylene (LLDPE). Specific examples of the polypropylene include a homopolymer, a random copolymer, a block copolymer, an isotactic polypropylene, an atactic polypropylene, and a syndiotactic polypropylene.

As these thermoplastic resins, commercially available resins are usually sufficient. Asahi Kasei Kogyo Co., Ltd., Mitsubishi Chemical Co., Ltd., Mitsui Chemicals Co., Ltd., Sumitomo Chemical Co., Ltd., Chisso Petrochemical Co., Ltd. Co., Ltd., Nippon Polyolefin Co., Ltd., Idemitsu Petrochemical Co., Ltd., Ube Industries, Ltd., Tokuyama Soda Co., Ltd., Nippon Synthetic Rubber Co., Ltd., Tosoh Co., Ltd. Further, as the polyolefin, a polyolefin obtained by copolymerizing a small amount of acrylic acid, methacrylic acid, maleic anhydride, vinyl acetate, or the like, or a polymer blend of the above-mentioned polyolefin and these can be used without any problem. Specific examples thereof include Modick (trade name, manufactured by Mitsubishi Chemical Corporation), Novatec APO
(Trade name, manufactured by Mitsubishi Chemical Corporation), Admar (trade name, manufactured by Mitsui Chemicals, Inc.), Bondyne, Acklift (trade name,
Sumitomo Chemical Co., Ltd.).

The above-mentioned polybutene, polybutadiene, polyisoprene, and poly-4-methylpentene-1 are also usually commercially available products.
PX (trade name, manufactured by Mitsui Chemicals, Inc.), JSR-RB, J
SR-IR (trade name, manufactured by Nippon Synthetic Rubber Co., Ltd.), Claprene (trade name, manufactured by Kuraray Co., Ltd.) and the like can be mentioned.

The above-mentioned polystyrene, polyvinyl acetate, polymethyl methacrylate, polyethyl methacrylate, polyacrylic acid, cyclic polyolefin and polyacrylonitrile are also sufficient as ordinary commercial products.
S-bright (trade name, Japan Polyolefin Co., Ltd.)
Denka Styrol, Denka ASR (trade name, manufactured by Denki Kagaku Kogyo Co., Ltd.), Styron, Delpet (trade name, manufactured by Asahi Kasei Kogyo Co., Ltd.), Idemitsu Polystyrene (trade name, manufactured by Idemitsu Petrochemical Co., Ltd.) ), Estyrene (trade name, manufactured by Nippon Steel Chemical Co., Ltd.), Sumibright, Sumipet (trade name, manufactured by Sumitomo Chemical Co., Ltd.), JSR Styrol, Arton (trade name, Nippon Synthetic Rubber Co., Ltd.) ), Gosenil (trade name, manufactured by Nippon Synthetic Chemical Co., Ltd.), Parapet (trade name, manufactured by Kuraray Co., Ltd.), Apel (trade name, manufactured by Mitsui Chemicals, Inc.), Zeonex (trade name, Nippon Zeon (trade name) Co., Ltd.), Barex (trade name, manufactured by Mitsui Chemicals, Inc.)
And the like.

The above-mentioned polyamides (nylons), polyesters, polyurethanes, polycarbonates, and thermoplastic elastomers are also sufficient as ordinary commercial products. Specifically, for example, NOVAREX, GRILAMID, NOVAPET (trade names, Mitsubishi Chemical Corporation) )), Ube Nylon (trade name, manufactured by Ube Industries, Ltd.), Leona, Sanpet (trade name, manufactured by Asahi Kasei Kogyo Co., Ltd.), Toray Nylon, Pebax, Hytrel (trade name, manufactured by Toray Industries, Inc.) , Daiamide (trade name, manufactured by Daicel Huls Co., Ltd.), Pandex, Relax (trade name, manufactured by Dainippon Ink and Chemicals, Inc.), Toyobo Nylon, Virpet, Perprene (trade name, Toyobo Co., Ltd.) Co., Ltd.), Unitika Nylon, G-PET (trade name, made by Unitika Ltd.), Paraprempet (trade name,
Nippon Polyurethane Industry Co., Ltd.), Iupilon (trade name, manufactured by Mitsubishi Engineering Plastics Co., Ltd.),
Mirastomer (trade name, manufactured by Mitsui Chemicals, Inc.), Sumitomo TPE (trade name, manufactured by Sumitomo Chemical Co., Ltd.), Thermolan, JSR-TR, Dynalon (trade name, manufactured by Nippon Synthetic Rubber Co., Ltd.) Can be mentioned.

The above-mentioned thermoplastic polyimides and polyphenylene sulfides are also sufficient as ordinary commercial products. Specifically, for example, Meldin (trade name, Mitsui Chemicals, Inc.)
Manufactured), FORTRON (trade name, Kureha Chemical Industry Co., Ltd.)
), Ryton PPS (trade name, manufactured by Philips Sekiyu KK), Novops (trade name, manufactured by Mitsubishi Chemical Corporation)
And the like.

The above-mentioned copolymer used in the present invention is also a commercially available product, and can be obtained from the above-mentioned manufacturer. Further, among the above-mentioned copolymers used in the present invention, a copolymer composed of a portion composed mainly of styrene and / or ethylene and a portion composed of butadiene and / or isoprene and / or a hydrogenated product thereof. Can also be preferably used.
They are usually commercially available as styrene-based elastomers, and specifically, for example, Clayton,
Califrex (trade name, manufactured by Shell Chemical Co., Ltd.), Tufprene, Tuftec (trade name, manufactured by Asahi Kasei Corporation),
Aron AR (trade name, manufactured by Aron Kasei Co., Ltd.), Lavalon (trade name, manufactured by Mitsubishi Chemical Corporation), JSR-TR, JSR
-SIS, Dynalon (trade name, Nippon Synthetic Rubber Co., Ltd.)
Manufactured), TPE-SB (trade name, Sumitomo Chemical Co., Ltd.)
), Septon, Hibler (trade name, manufactured by Kuraray Co., Ltd.) and the like.

Further, as the thermoplastic resin which is a raw material of the sheet, film and port member used in the present invention, the above-mentioned portion containing styrene and / or ethylene as a main component, butadiene and / or isoprene and / or Or a copolymer composed of a portion consisting of a hydrogenated product thereof,
A thermoplastic resin comprising a polymer blend with polyethylene and / or polypropylene and / or polybutene can be preferably used. These are described in JP-A-54-88950, JP-A-4-314452, and the like, and can provide a transparent, flexible, and autoclave-sterilizable medical bag. The sheet or film used in the present invention may have a single layer or a multilayer structure. The thickness of the sheet or film is not particularly limited. However, 0.05 mm or more and 2 mm or less are desirable. If it is less than 0.05 mm, the strength of a medical container cannot be maintained, and if it exceeds 2 mm, there is a problem in flexibility.

In the case of a sheet having a multilayer structure, a material that easily generates heat when a high frequency is applied to the inner surface, that is, a polyamide, polyester, or polyurethane, which is a material that can be conventionally sealed with a high frequency, may be used. It may be preferable. However, the thickness of the material that generates heat by these high-frequency seals is 2% or more and 95% or more of the entire thickness.
The following is desirable. The manufacturing process of the multilayered sheet or film used in the present invention is not particularly limited.
For example, any of dry lamination, wet lamination, and co-extrusion molding may be used, and other methods may be used. Sheet or film used in the present invention,
It is desirable that the innermost layer of the medical container is composed of a multi-layer sheet made of a thermoplastic elastomer selected from polyamide elastomer, polyester elastomer and polyurethane elastomer.

As the polyamide elastomer, polyamide having a crystalline and high melting temperature as a hard segment,
A multiblock copolymer using an amorphous polyether or polyester having a low glass transition temperature in the soft segment, that is, a so-called polyetheramide (also referred to as polyetheresteramide) or polyesteramide can be preferably used. These may be ordinary commercial products, but are not limited thereto. Specifically, for example, diamide-PAE (trade name, Daicel
Huls Co., Ltd.), UBE nylon PAE (trade name,
Ube Industries, Ltd.), Grillon ELX, Grillon ELY
(Product name, manufactured by MMS Japan Co., Ltd.), Relax A
(Trade name, manufactured by Dainippon Ink and Chemicals, Inc.), Novamid EL (trade name, manufactured by Mitsubishi Chemical Corporation), Pebax (trade name, manufactured by Atochem Co., Ltd.), and the like.

As the polyester elastomer, an aromatic polyester is used for the hard segment, for example, 1,4-
Polycondensate of butanediol and terephthalic acid, polyester / polyether type using aliphatic polyether polytetramethylene glycol for soft segment,
A polyester / polyester type using an aliphatic polyester for the soft segment can be preferably used. These are sufficient as ordinary commercial products, and specifically, for example, Perprene (trade name, manufactured by Toyobo Co., Ltd.), Hytrel (trade name, manufactured by Toray Dupont Co., Ltd.), and GREAK E
(Trade name, manufactured by Dainippon Ink and Chemicals, Inc.), Lomod (trade name, manufactured by Nippon GE Plastics Co., Ltd.), Pibiflex (trade name, manufactured by Nippon Synthetic Rubber Co., Ltd.), and the like.

As the polyurethane elastomer, 4,
Those using 4'-diphenylmethane diisocyanate (MDI), 1,4-butanediol (BD) as a chain extender, and polyol or polyester as a soft segment can be preferably used. These are sufficient as commercial products, and specifically, for example, Pandex (trade name, manufactured by Dainippon Ink and Chemicals, Inc.), milactran (trade name, manufactured by Nippon Milactran Co., Ltd.), Resazin P (trade name) Name, manufactured by Dainichi Seika Kogyo Co., Ltd.), Elastran (trade name, manufactured by Takeda Birdish Urethane Industry Co., Ltd.), Ufine (trade name, manufactured by Asahi Glass Co., Ltd.), Esten, Estalok (trade name, Kyowa Hakko Kogyo Co., Ltd.), Desmopan, Texin (trade name, manufactured by Sumitomo Bayer Urethane Co., Ltd. and Bayer Japan Co., Ltd.) and the like. The thermoplastic resin used in the present invention, and the film, sheet, port member, and the like made of the thermoplastic resin preferably conform to the plastic container test method of the Japanese Pharmacopoeia.

The method for producing a medical container of the present invention comprises the steps of (1)
A sheet or film of the thermoplastic resin constituting the front and back surfaces of the medical container body is interposed between a mold (electrode) and a lower plate (electrode), and a core is interposed between the thermoplastic resin sheet or film. A first application step of sequentially applying a high-frequency voltage between a core (electrode) and a mold (electrode) or a lower plate (electrode) through a port member into which the gold (electrode) is inserted;
(2) a second application step of applying a high-frequency voltage between the mold (electrode) and the lower plate (electrode). It is desirable that the first application step and the second application step are performed in this order, but a method of performing the first application step after the second application step may be used. The step of applying to either the mold (electrode) or the lower plate (electrode) and the core metal (electrode) and the second applying step may be performed simultaneously.

In the first application step, a high-frequency voltage is applied between one of the mold (electrode) or the lower plate (electrode) and the core (electrode), and then the other is applied. A high-frequency voltage can be applied in between. Preferably lower plate
A high frequency voltage is applied between the (electrode) and the core (electrode) to adhere the port member and the sheet or film on the lower plate (electrode) side, and then the mold (electrode) and the core (electrode) Preferably, a step of applying a high-frequency voltage between the two and bonding the port member and the sheet or film on the mold (electrode) side.

Next, the manufacturing method of the present invention will be specifically described with reference to the drawings. It is not necessary to use a special high-frequency dielectric heat sealing machine used in the present invention, for example, the same as the high-frequency welder used for fusing sheets of soft polyvinyl chloride or ethylene-vinyl acetate copolymer The device is sufficient. FIG. 1 shows a mold (electrode), lower plate (electrode) and core metal (electrode) of a high-frequency welder used in the present invention.
It is a perspective view explaining the principal part of one reference example. FIG. 2 is a perspective view illustrating a reference example of a hollow port member for attaching a pipe.

1 and 2, reference numeral 1 denotes a mold (electrode), 2 denotes a lower plate (electrode), and 3 denotes a core (electrode). The mold (electrode) 1 holds concave portions 4A, 4A for holding and pressurizing and sealing the port member 4 for high-frequency sealing, a convex portion 5C for forming an adhesive portion near the port member 4, and a medical container. Convex part 5 for forming the bonding part of the main body
A is provided. One lower plate (electrode) 2 also holds the port member 4 for high-frequency sealing and presses and seals the concave portions 4B and 4B and the convex portion 5C for forming an adhesive portion near the port member 4 and a medical device. A projection 5B is provided for forming an adhesive portion of the main body of the container. The core metal (electrode) 3 has an outer diameter slightly smaller than the inner diameter of the hollow portion 6 of the port member 4, and the hollow of the port member 4 held between the mold (electrode) 1 and the lower plate (electrode) 2. It can be inserted almost in close contact with the part 6. 11 is a cutter.

FIG. 3 is an explanatory view showing an example of the steps of the method for producing a medical container of the present invention. 1 and 2 denote the same components. (A) Two films or sheets 7 and 8 of the same or different type are automatically or manually interposed between a mold (electrode) 1 and a lower plate (electrode) 2. The hollow portion 6 is located at a predetermined position between
The port member 4 into which the core metal (electrode) 3 is inserted in close contact with the substrate is automatically or manually interposed. (B) By moving the mold (electrode) 1 and the lower plate (electrode) 2 in the direction of the arrow shown in the step (a), the port member 4 into which the core metal (electrode) 3 was inserted was interposed. A predetermined portion of the two films or sheets 7 and 8 to be bonded is pressed with a predetermined pressure.

First, a high-frequency voltage is applied between the lower plate (electrode) 2 and the metal core (electrode) 3 based on a signal from a control device (not shown), and a film or sheet on the lower plate (electrode) 2 side is applied. 8 and the port member 4 are subjected to high-frequency dielectric heating to bond the portions 9B to be bonded to each other. Thereafter, based on a signal from a control device (not shown), the lower plate (electrode) 2 and the core metal (electrode)
The application of the high frequency voltage to 3 is stopped.

(C) Next, similarly, a high-frequency voltage is applied between the mold (electrode) 1 and the core metal (electrode) 3, and the film or sheet 7 on the mold (electrode) 1 side is connected to the port. The member 4 is subjected to high-frequency dielectric heating to bond the portions 9A to be bonded to each other. Thereafter, in the same manner, the mold (electrode) 1 and the core metal (electrode)
The application of the high frequency voltage to 3 is stopped. (D) Next, similarly, the mold (electrode) 1 and the lower plate (electrode)
2, a predetermined location 9C to be bonded near the port member 4 bonded to the two films or sheets 7 and 8 and a medical container 10 (not shown).
Is bonded by high-frequency dielectric heating. Thereafter, the application of the high-frequency voltage to the mold (electrode) 1 and the lower plate (electrode) 2 is similarly stopped. (E) Then, the mold (electrode) 1 and the lower plate (electrode) 2 are separated in the direction shown by the arrow, the core metal (electrode) 3 is removed, and a product (medical container) having two port members 4 is provided. Take 10 out. (F) Then, the above steps (a) to (e) are repeated, and the product (medical container) 10 is manufactured continuously or automatically by high-frequency dielectric heating.

FIG. 4 is an explanatory view showing the medical container 10 manufactured by the above-described manufacturing method of the present invention. The same reference numerals as those in FIG. 3 indicate the same components. As an example of another manufacturing method of the medical container of the present invention, a convex portion 5C for forming an adhesive portion near the port member 4 is provided, but a convex portion for forming an adhesive portion of the main body of the medical container 10 is provided. Using a not-shown mold (electrode) and a lower plate (electrode) not provided with the portions 5A and 5B,
In the step (d), first, a film to which the port member 4 is bonded or a predetermined portion 9C to be bonded in the vicinity of the port member 4 of the sheets 7, 8 is bonded by high-frequency dielectric heating, and then the same high-frequency welder is used. A mold (electrode) (not shown) and a lower plate (electrode) not shown or using another high-frequency welder and having projections 5A and 5B for forming an adhesive portion of the main body of the medical container 10 are formed. For example, the remaining portions 9 to be bonded of the films or sheets 7 and 8 may be bonded by high-frequency dielectric heating.

There is no particular limitation on which of the above manufacturing methods is used. However, when the sealing conditions for bonding the port member 4 to the film or sheets 7 and 8 and the sealing conditions for bonding the bonding portion 9 of the main body of the medical container 10 are similar, either method is used. However, if the sealing conditions are different, it is preferable to bond them separately.

As another example of the method for producing a medical container of the present invention, there may be mentioned an example in which step (c) and step (d) are simultaneously performed in the above-mentioned steps. That is, after the step (b), a high-frequency voltage is applied to the mold (electrode) 1 and the core metal (electrode) 3, and the film or sheet 7 and the port member 4 on the mold (electrode) 1 side are subjected to high-frequency dielectric. By heating, the portions 9A to be bonded are bonded together, and the mold (electrode) 1
A high frequency voltage is also applied to the lower plate (electrode) 2 and the predetermined portion 9C of the two films or sheets 7, 8 to be bonded can be subjected to high frequency dielectric heating. Also in this case, the bonding of the bonding portion 9 of the main body of the medical container 10 is performed by the port member 4.
May be performed at the same time as the bonding of the portion 9C near the above, or may be performed separately as described above.

As another example of the method for manufacturing a medical container according to the present invention, in the above-mentioned steps, the step (c) is advanced to advance the film or sheet 7 on the mold (electrode) 1 side and the port member. 4 is subjected to high-frequency dielectric heating to bond the portions 9A to be bonded to each other, and then a high-frequency voltage is applied to the lower plate (electrode) 2 and the core metal (electrode) 3 in step (b), An example can be given in which the film or sheet 8 on the side of the (electrode) 2 and the port member 4 are subjected to high-frequency dielectric heating to bond the portions 9B to be bonded to each other.

Also in this example of the manufacturing method of the present invention, when the step (b) is performed after the step (c) is advanced, the steps (b) and (d) can be performed simultaneously. Also in this case, the bonding of the bonding portion 9 of the main body of the medical container 10 may be performed simultaneously with the bonding of the portion 9C near the port member 4, or may be performed separately as described above.

As another example of the method for manufacturing the medical container of the present invention, a high frequency voltage is applied between the lower plate (electrode) 2 and the mold (electrode) 1 and the core metal (electrode) 3. After the films or sheets 7, 8 and the port member 4 are subjected to high-frequency dielectric heating to bond the parts 9B, 9A to be bonded to each other, the lower plate (electrode) 2, the mold (electrode) 1, and the core metal (electrode) 3 Application of the high-frequency voltage to the mold (electrode) 1 is stopped.
And a lower plate (electrode) 2 by applying a high frequency voltage
All predetermined portions 9C and 9 of the films or sheets 7 and 8 to be bonded are bonded by high-frequency dielectric heating, or the two films or sheets 7 and 8 in the vicinity of the bonded port member 4 are bonded. After the predetermined location 9C to be bonded is bonded by high-frequency dielectric heating, the remaining predetermined location 9 to be bonded of the two films or sheets is subjected to high-frequency dielectric heating using the high-frequency welder or another high-frequency welder. Bonding.
There is no particular limitation on which of the above manufacturing methods the medical container is manufactured, and it is preferable to appropriately select and manufacture the medical container according to the dimensions, type, shape, type of contents to be filled, and the like.

When a hollow port member such as a port member for attaching a film, a sheet, or a pipe is bonded by high-frequency dielectric heating according to the production method of the present invention, these temperatures are not particularly limited. However, the mold (electrode), lower plate (electrode), and core metal (electrode) of the high-frequency welder are heated to an appropriate temperature, and the film, sheet, and port member to be bonded are heated to an appropriate temperature below the melting point, for example. Is preferred. It is preferable that the sealing pressure, the sealing time, the high-frequency output, and the like be controlled in a range where good adhesion can be obtained by high-frequency dielectric heating.

In the present invention, the film, sheet, and port member to be bonded may or may not be preheated.
If preheating causes deformation due to warping or shrinking, residual heat is not preferred. When the film, sheet, or port member absorbs moisture or has moisture or oil adhered to the surface, it is preferable to perform pretreatment such as drying or cleaning the surface.

Specific examples of the temperature of the mold, lower plate, and core metal are about 95 to 100 ° C. for polyamide resin, about 60 to 70 ° C. for styrene elastomer,
Examples include about 50 ° C. for a polyolefin copolymer and about 120 ° C. for a crystalline polypropylene composition. Specific examples of the sealing pressure and the sealing time are about 30 to 50 in the case of a polyamide resin film.
kg / cm ^2, 1 to 5 seconds, when about 10 to 30 kg / cm ² of the styrene-based elastomer film, 1-4 seconds, about the case of the polyolefin copolymer films 10 to 30 kg
/ Cm ² , 1 to 3 seconds, and about 40 to 60 kg / cm ^{2 for} a crystalline polypropylene composition film, 3 to 7 seconds. Usually, it is preferable to keep the pressure for the time necessary for cooling after the elapse of the sealing time.

In the present invention, the unheated mold, lower plate, and core are cooled to prevent films, sheets, and port members from adhering to the mold, lower plate, or core. Or the sealing speed can be improved. The cooling temperature is not particularly limited, and is preferably determined as appropriate depending on the characteristics of the thermoplastic resin, and the shape, size, thickness, and the like of the film, sheet, and port member.

In the present invention, when a film, a sheet, and a port member for high frequency sealing are interposed between the mold and the lower plate, Teflon (registered trademark) is provided between the mold and / or the film and sheet for high frequency sealing with the lower plate. When an easily peelable insulating sheet such as a coated glass cloth is further interposed,
The high-frequency sealed film and sheet are preferable because they have good peeling properties and do not spark or burn or shrink. It is also preferable to make the surfaces of the mold, the lower plate and the core metal releasable.

The mold used in the present invention is not particularly limited. Usually, there are two types of molds: bends made of brass or other metal and soldered or screwed to the frame, and sculptures made by engraving metal blocks such as brass. can do. The "bending mold" can be manufactured in a short period of time and has the advantage of low cost, so it is suitable for small-quantity production.On the other hand, it has the disadvantage of poor durability. Are suitable.

FIG. 5 is a sectional view of an essential part showing a preferred embodiment of a mold used in the present invention, and is an enlarged sectional view of the vicinity of the convex portion 5C in FIG. In FIG.
Cutter 1 on the side surface of the mold 1 in the area of the bonded portion
A notch 12 having an inclined surface 12A whose depth gradually increases toward the cutter 11 side with respect to the tip end surface of the mold 1 is provided. 1 is provided along the arrangement surface.

The inclination angle θ of the inclined surface 12A in the notch 12 is preferably 5 to 30 degrees, more preferably 5 to 1
5 degrees. If the inclination angle θ is less than 5 degrees, the edge cutting phenomenon of the welded portion is liable to occur, and if it exceeds 30 degrees, sparks and film or sheet peeling phenomena tend to occur during welding. Further, the R shape of the inclined surface is preferably 5R to 10R, more preferably 5R to 8R. If the R shape of the inclined surface is smaller than 5R, excessive welding occurs, and the balance of the welded portion formed by welding tends to be lacking. Also,
If the R shape of the inclined surface is larger than 10R, the resin sagging phenomenon is likely to occur, and the formation of the product becomes unstable. The width of the notch 12 (denoted by L in the drawing) differs depending on the product to be manufactured, and the width L is selected according to the welding width.

When a medical container is manufactured by using the mold 1 having the notch 12, the welded portion has no portion that returns to the inclined surface, the appearance of the product is excellent, and the pressure on the film or sheet is reduced. The tip portion, that is, the rate of decrease due to the R shape of the inclined surface is small, the adhesive strength of the welded portion is high,
The tear strength of the welded portion can be maintained at a high level.

The environment, atmosphere, etc., when manufacturing a medical container by the method of the present invention are not particularly limited. However, for example, the United States National Aeronautics and Space Administration (NASA) standard class 10
It is preferable to perform high-frequency sealing and work in a clean room or clean booth of class 0 to 10,000.

The adhesive strength of the adhesive portion of the medical container of the present invention produced by the method of the present invention is a port member for attaching a pipe to a sheet or a film, even in the case of bonding between sheets and films. Even in the case of bonding with a member such as the above, it is preferably 0.1 kgf / cm or more, and more preferably 0.8 kgf / cm or more. This adhesive strength is a value that requires special attention in the case of a medical container in which an infusion solution, a drug solution, or the like is put therein and sterilized in an autoclave or blood is put in and centrifuged. Adhesive strength is 0. When it is less than 1 kgf / cm, there is a possibility that an adhesive portion may be peeled off when an infusion solution or a drug solution is charged and sterilized in an autoclave or when blood is charged and centrifuged.

FIG. 6 shows a method of testing the bonding strength of the bonding portion. The two films or sheets 7 and 8 bonded at the bonding portion 9 are sealed with a width of 5 mm, and cut into a strip having a width of 2 cm in a direction perpendicular to the width of the seal. The sheet pieces 7 and 8 were chucked by setting the distance between chucks of a tensile tester (for example, an autograph manufactured by Shimadzu Corporation or a strograph manufactured by Toyo Seiki Seisakusho) to 20 mm, and a tensile speed of 200 mm / min. The value obtained by dividing the maximum value when the test piece was pulled at (23 ° C.) in the direction of the arrow until the test piece broke was divided by 2 and converted per 1 cm width is defined as the adhesive strength.

The medical container of the present invention is not particularly limited as long as it is used at a medical site, and its type, shape, size, color, presence or absence of printing, and the like are not particularly limited. Specific examples of the medical container of the present invention include, for example, a “blood bag” for storing blood and blood components, a “cell culture bag” for storing biological cells such as bone marrow and lymphocytes, and a “urine collection” for storing urine. Bags, infusion bags for storing infusion liquids, IVH bags for storing nutrients for direct administration to the central vein, etc., bags for enteral nutrition, bags for storing various drug solutions, etc. Various bags can be mentioned.

The method of filling the contents into the medical container of the present invention is not particularly limited. Specifically, for example, the content liquid is filled from the hollow portion of the port member of the medical container of the present invention.
Then, if necessary, the inside air is removed, and a hollow portion at the tip of the port member is sealed with a rubber stopper. It is preferable to attach a plastic film or attach a cover to the upper surface of the rubber stopper in order to maintain sterility. This rubber stopper is used for mixing a drug such as an antibiotic or insulin according to the patient into the container when the content liquid is an infusion. Thereafter, a sterilization treatment is usually performed in an autoclave at 121 ° C. for 20 minutes.

In the case of the above-mentioned "blood bag", "cell culture bag", "urine collection bag", etc., they may be marketed without being filled with the content liquid. The dielectric constant used in the present invention is a value measured at room temperature and 1000 Hz according to JIS K6911 “General Test Method for Thermosetting Plastics”.

[0054]

EXAMPLES The present invention will now be described specifically with reference to examples and comparative examples, but the present invention is not limited to these examples. (Example 1) A low-density polyethylene (LDPE) (trade name; LK-52, manufactured by Nippon Polychem Co., Ltd.) was used as a raw material, and an extruder (Laboplast Mill, manufactured by Toyo Seiki Seisaku-sho, Ltd.) with a T of 120 mm. Attach the die, thickness about 0.
Sheets 7 and 8 of 20 mm were obtained. In addition, an injection molding machine (FS80S12) was used as a raw material of low density polyethylene (LDPE) (trade name: LM-31, manufactured by Nippon Polychem Co., Ltd.).
A tube mounting port member 4 having an inner diameter 10 mm, a wall pressure 1 mm, and an outer diameter 12 mm of the hollow portion 6 shown in FIG. 2 was formed by ASE (manufactured by Nissei Resin Industry Co., Ltd.). The above sheet 7,
The dielectric constant of No. 8 was 2.3, and the dielectric constant of the tube mounting port member 4 was 2.3.

Subsequently, a high-frequency welder remodeling apparatus (Yamamoto Vinita (see FIG. 1) having a mold (electrode) 1, a lower plate (electrode) 2, and a core (electrode) 3 (outer diameter of about 9.5 mm) shown in FIG. (VW-5000, manufactured by K.K. Co., Ltd.) and high frequency sealing in the bag shape shown in FIG. 4 by the steps (a) to (e) shown in FIG.
A, 9B, the sealing width of the bonding portion 9C near the port member 4 is 10 mm, and the sealing width of the bonding portion 9 of the main body is 5 mm.) The medical container 10 of the present invention was manufactured continuously. Sealing condition: oscillation frequency 40.46 MHZ ± 0.599
%, Applied voltage 200V, output 5KW, mold temperature 100 ±
3 ℃, core metal temperature 100 ± 3 ℃, lower plate temperature 100 ± 3 ℃.

Step: (a) Between the mold (electrode) 1 and the lower plate (electrode) 2,
A port member 4 in which a core metal (electrode) 3 is inserted into a predetermined position shown in FIG. 3 between the two sheets 7 and 8 with the core metal (electrode) 3 interposed therebetween. By moving the mold (electrode) 1 and the lower plate (electrode) 2 in the direction of the arrow, the two sheets 7 with the boat member 4 into which the core metal (electrode) 3 is inserted, A predetermined pressure (9B, 9A, 9C, 9) where 8 is to be bonded is set to a sealing pressure of 30 kg.
/ Cm ² . (B) A high-frequency voltage is applied between the lower plate (electrode) 2 and the core metal (electrode) 3 (oscillation time 5 seconds, anode current 0.35 A),
The sheet 8 on the side of the lower plate (electrode) 2 and the port member 4 are subjected to high-frequency dielectric heating to bond the bonding portion 9B (seal width 10 mm).
I do. Thereafter, the application of the high-frequency voltage to the lower plate (electrode) 2 and the cored bar (electrode) 3 is stopped. (C) Next, a high-frequency voltage is applied between the mold (electrode) 1 and the core (electrode) 3 (oscillation time 5 seconds, anode current 0.35
A), the sheet 7 on the side of the mold (electrode) 1 and the port member 4 are subjected to high-frequency dielectric heating to bond the bonded portion 9A (seal width 10).
mm). Then, a mold (electrode) 1 and a core metal (electrode) 3
The application of the high frequency voltage to is stopped. (D) Next, a high-frequency voltage is applied between the mold (electrode) 1 and the lower plate (electrode) 2 (oscillation time 5 seconds, anode current 0.3
A), the bonding portion 9 near the port member 4 of the sheets 7 and 8
C (seal width 10 mm) and the bonding portion 9 (seal width 5 mm) of the main body of the medical container 10 are bonded by high-frequency dielectric heating. Thereafter, the application of the high-frequency voltage to the mold (electrode) 1 and the lower plate (electrode) 2 is stopped. (E) Then, the mold (electrode) 1 and the lower plate (electrode) 2 are separated, the core metal (electrode) 3 is removed, and a product (medical container) having two port members 4 (width 100 mm, length 200m
m) Take 10 out. (F) Then, the above steps (a) to (e) are repeated to manufacture the product (medical container) 10 continuously by high-frequency dielectric heating.

Sealing result: The sheet and tube mounting port member 4 constituting the medical container 10 of the present invention were in a good molten state, and could be completely and completely sealed without burrs. Table 1 shows the results obtained by cutting out the bonded portions 9C and 9 to a width of 2 cm and determining the bonding strength. 200 ml of bovine blood was put into the medical container 10 of the present invention described above, and after closing the hollow portion of the port member 4, centrifugation (centrifugation test) was performed at 3000 rpm for 10 minutes. There was no problem.

Example 2 Instead of the low-density polyethylene (LK-52) of Example 1, polypropylene (trade name: EX-6, manufactured by Nippon Polychem Co., Ltd.) was replaced with low-density polyethylene (LM-31). ) Was replaced with polypropylene (trade name: MG-3C, manufactured by Nippon Polychem Co., Ltd.) to produce a sheet and a port member 4 in the same manner as in Example 1. Another medical container 10 of the present invention was produced in the same manner as in Example 1 under the following sealing conditions. The dielectric constant of the sheet was 2.3, and the dielectric constant of the tube mounting port member 4 was 2.3. Sealing condition: oscillation frequency 40.46 MHZ ± 0.599
%, Applied voltage 200V, output 5KW, mold temperature 120 ±
3 ℃, core metal temperature 120 ± 3 ℃, lower plate temperature 120 ± 3 ℃,
Cooling time 5 seconds, seal pressure 50 kg / cm ² .

Sealing result: Another medical container 10 of the present invention
And tube mounting port member 4 that constitutes
Was in a good molten state, without burrs as a whole, and the finished appearance was good. Similarly, another medical container 1 of the present invention
Table 1 shows the results of the test of the bonding strength of the bonded portions 9C and 9 of No. 0. 500 ml of physiological saline (manufactured by Terumo Corporation) was placed in the other medical container 10 of the present invention, and after closing the hollow portion of the port member 4, autoclaving was performed at 121 ° C for 20 minutes (autoclave resistance). Test), but there was no problem such as leakage of the content liquid.

Example 3 Polypropylene (trade name; E
X-6, manufactured by Nippon Polychem Co., Ltd.) at 40.0 wt%, a styrene-based elastomer (trade name: Clayton G165)
2, 59.9% by weight of Shell Chemical Co., Ltd.) and 0.1% of an antioxidant (trade name: Irganox 1010, Ciba-Geigy). lwt% to twin screw extruder (Ikegai Iron Works Co., Ltd.)
And PCM), extruded into strands, and cut with a pelletizer to obtain raw material pellets. In the same manner as in Example 1, the sheet and the port member 4 were formed from this raw material.
Then, another medical container 10 of the present invention was produced in the same manner as in Example 1 under the following sealing conditions. Sealing condition: oscillation frequency 40.46 MHZ ± 0.599
%, Applied voltage 200V, output 5KW, mold temperature 110 ±
3 ℃, core metal temperature 110 ± 3 ℃, lower plate temperature 110 ± 3 ℃,
Cooling time 5 seconds, sealing pressure 40 kg / cm ² .

Seal result: Other medical container 10 of the present invention
And tube mounting port member 4 that constitutes
Was in a good molten state, without burrs as a whole, and the finished appearance was good. Similarly, another medical container 1 of the present invention
Table 1 shows the results of the test of the bonding strength of the bonded portions 9C and 9 of No. 0. A centrifugation test and an autoclave resistance test were performed in the same manner as in Example 1 and Example 2, but there was no particular problem.

Example 4 Polypropylene (trade name; E
X-6, 30.0% by weight of Nippon Polychem Co., Ltd., 69.9% by weight of an elastomer (trade name: Dynaron E6100P, manufactured by Nippon Synthetic Rubber Co., Ltd.), an antioxidant (trade name: Irganox 1010, 0.1 wt% of Ciba-Geigy Co., Ltd. and a twin-screw extruder (Ikegai Iron Works Co., Ltd., PC
M), extruded into strands, and cut with a pelletizer to obtain raw material pellets. In the same manner as in Example 3, a sheet and a port member 4 were formed from the raw material pellets. Then, another medical container 10 of the present invention was produced in the same manner as in Example 1 under the following sealing conditions. Sealing condition: oscillation frequency 40.46 MHZ ± 0.599
%, Applied voltage 200V, output 5KW, mold temperature 100 ±
3 ℃, core metal temperature 100 ± 3 ℃, lower plate temperature 100 ± 3 ℃,
Cooling time 4 seconds, seal pressure 30 kg / cm ² .

Seal Result: Another Medical Container 10 of the Present Invention
And tube mounting port member 4 that constitutes
Was in a good molten state, without burrs as a whole, and the finished appearance was good. Similarly, another medical container 1 of the present invention
Table 1 shows the results of the test of the bonding strength of the bonded portions 9C and 9 of No. 0. A centrifugation test and an autoclave resistance test were performed in the same manner as in Example 1 and Example 2, but there was no particular problem.

Example 5 Polypropylene (trade name; E
X-6, manufactured by Nippon Polychem Co., Ltd.) in an amount of 30.0 wt%, a styrene-based elastomer (trade name: SEPTON 4033,
69.9% by weight of Kuraray Co., Ltd., 0.1% by weight of an antioxidant (trade name: Irganox 1010, manufactured by Ciba-Geigy), and a twin-screw extruder (PC manufactured by Ikegai Iron Works, Ltd.
M), extruded into strands, and cut with a pelletizer to obtain raw material pellets. In the same manner as in Example 3, a sheet and a port member 4 were formed from the raw material pellets. Another medical container 10 of the present invention was produced in the same manner as in Example 1 under the following sealing conditions. Sealing condition: oscillation frequency 40.46 MHZ ± 0.599
%, Applied voltage 200V, output 5KW, mold temperature 100 ±
3 ℃, core metal temperature 100 ± 3 ℃, lower plate temperature 100 ± 3 ℃,
Cooling time 5 seconds, seal pressure 30 kg / cm ² .

Sealing result: Another medical container 10 of the present invention
And tube mounting port member 4 that constitutes
Was in a good molten state, without burrs as a whole, and the finished appearance was good. Similarly, another medical container 1 of the present invention
Table 1 shows the results of the test of the bonding strength of the bonded portions 9C and 9 of No. 0. A centrifugation test and an autoclave resistance test were performed in the same manner as in Example 1, but no particular problem was found.

Example 6 A base sheet (a) having a thickness of 0.15 mm was formed in the same manner using the same raw materials as in Example 3. Similarly, an adhesive resin (trade name: Bondyne TX-
8030, obtained from Sumitomo Chemical Co., Ltd.)
It was formed into a μm sheet (b). Further, a polyamide elastomer (trade name: PAE1200, manufactured by Ube Industries, Ltd.) was formed into a sheet (c) having a thickness of about 20 μm. Then, the base sheet (a) / adhesive resin sheet (b) / polyamide elastomer sheet (c) are stacked in this order and passed through a heat roll of a heat laminating apparatus to form a laminated sheet having a multilayer structure having a thickness of about 0.18 mm. I got This sheet is overlaid so that the polyamide elastomer sheet (c) becomes the inner surface of the medical container 10, and the same polyamide elastomer (trade name: PAEl2) is used.
00, manufactured by Ube Industries, Ltd.)
In addition, another medical container 10 of the present invention was produced in the same manner as in Example 1 under the following sealing conditions. Sealing condition: oscillation frequency 40.46 MHZ ± 0.599
%, Applied voltage 200V, output 5KW, mold temperature 100 ±
3 ℃, core metal temperature 100 ± 3 ℃, lower plate temperature 100 ± 3 ℃,
Cooling time 5 seconds,

Sealing result: Another medical container 10 of the present invention
And tube mounting port member 4 that constitutes
Was in a good molten state, without burrs as a whole, and the finished appearance was good. Similarly, another medical container 1 of the present invention
Table 1 shows the results of the test of the bonding strength of the bonded portions 9C and 9 of No. 0. A centrifugation test and an autoclave resistance test were performed in the same manner as in Example 1 and Example 2, but there was no particular problem.

Example 7 A polyamide elastomer (trade name; PAE1200, manufactured by Ube Industries, Ltd.) was replaced by a polyester elastomer (trade name: Hytrel 4047, manufactured by Du Pont-Toray Co., Ltd.) In the same manner as in Example 6, another medical container 10 of the present invention was produced under the following sealing conditions. Sealing condition: oscillation frequency 40.46 MHZ ± 0.599
%, Applied voltage 200V, output 5KW, mold temperature 100 ±
3 ℃, core metal temperature 100 ± 3 ℃, lower plate temperature 100 ± 3 ℃,
Cooling time 4 seconds, seal pressure 20 kg / cm ² .

Sealing result: Other medical container 10 of the present invention
And tube mounting port member 4 that constitutes
Was in a good molten state, without burrs as a whole, and the finished appearance was good. Similarly, another medical container 1 of the present invention
Table 1 shows the results of the test of the bonding strength of the bonded portions 9C and 9 of No. 0. A centrifugation test and an autoclave resistance test were performed in the same manner as in Example 1 and Example 2, but there was no particular problem.

Example 8 A polyamide elastomer (trade name: PAE1200, manufactured by Ube Industries, Ltd.) was replaced by a polyurethane elastomer (trade name: milactran E-395, manufactured by Nippon Milactran Co., Ltd.) In the same manner as in Example 6, another medical container 10 of the present invention was produced under the following sealing conditions. Sealing condition: oscillation frequency 40.46 MHZ ± 0.599
%, Applied voltage 200V, output 5KW, mold temperature 100 ±
3 ℃, core metal temperature 100 ± 3 ℃, lower plate temperature 100 ± 3 ℃,
Cooling time 4 seconds, seal pressure 20 kg / cm ² .

Sealing result: Other medical container 10 of the present invention
And tube mounting port member 4 that constitutes
Was in a good molten state, without burrs as a whole, and the finished appearance was good. Similarly, another medical container 1 of the present invention
Table 1 shows the results of the test of the bonding strength of the bonded portions 9C and 9 of No. 0. A centrifugation test and an autoclave resistance test were performed in the same manner as in Example 1 and Example 2, but there was no particular problem.

(Comparative Example 1) The same sheet and port member 4 as in Example 1 were heat-sealed in the same bag shape as the medical container 10 of the present invention using a heat sealing machine (self-made machine). Sealing conditions are: mold temperature 160 ° C, sealing time 5
Second, the cooling time was 15 seconds, and the working time was longer than that of Example 1. The finished aesthetic appearance of the seal was uneven because the surface of the port member 4 was unevenly melted, and large burrs were generated under the condition of sealing without leakage, which was not satisfactory. Table 1 shows the test results of the bonding strength of the bonded portions 9C and 9. There was no particular problem in the centrifugation test.

(Comparative Example 2) The same sheet and port member 4 as in Example 2 were heat-sealed in the same bag shape as the medical container 10 of the present invention using a heat sealing machine (self-made machine). Sealing conditions are: mold temperature 280 ° C, sealing time 6
Seconds and a cooling time of 23 seconds, and the working time was much longer than that of Example 2. The finished aesthetic appearance of the seal was uneven because the surface of the port member 4 was unevenly melted, and large burrs were generated under the condition of sealing without leakage, which was not satisfactory. Table 1 shows the test results of the bonding strength of the bonded portions 9C and 9. There were no particular problems in the centrifugation test and the autoclave test.

(Comparative Example 3) The same sheet and port member 4 as in Example 3 were heat-sealed in the same bag shape as the medical container 10 of the present invention using a heat sealing machine (self-made machine). Sealing conditions are: mold temperature 280 ° C, sealing time 8
Seconds and a cooling time of 27 seconds, and the working time was much longer than that of Example 3. The finished aesthetic appearance of the seal was uneven because the surface of the port member was unevenly melted, and large burrs were generated under the condition of sealing without leakage, which was not satisfactory. Table 1 shows the test results of the bonding strength of the bonded portions 9C and 9. There were no particular problems in the centrifugation test and the autoclave resistance test.

(Comparative Example 4) The same sheet and port member 4 as in Example 4 were heat-sealed in the same bag shape as the medical container 10 of the present invention using a heat sealing machine (self-made machine). Sealing conditions are: mold temperature 280 ° C, sealing time 8
Seconds and a cooling time of 30 seconds, and the working time was much longer than that of Example 4. The finished aesthetic appearance of the seal was uneven because the surface of the port member was unevenly melted, and large burrs were generated under the condition of sealing without leakage, which was not satisfactory. Table 1 shows the test results of the bonding strength of the bonded portions 9C and 9. There were no particular problems in the centrifugation test and the autoclave resistance test.

(Comparative Example 5) The same sheet and port member 4 as in Example 5 were heat-sealed in the same bag shape as the medical container 10 of the present invention using a heat-sealing machine (self-made machine). Sealing conditions are: mold temperature 230 ° C, sealing time 8
Seconds and a cooling time of 24 seconds, and the working time was much longer than that of Example 5. The finished aesthetic appearance of the seal was uneven because the surface of the port member was unevenly melted, and large burrs were generated under the condition of sealing without leakage, which was not satisfactory. Table 1 shows the test results of the bonding strength of the bonded portions 9C and 9. There was no particular problem in the centrifugation test.

(Comparative Example 6) The same sheet and port member 4 as in Example 6 were heat-sealed in the same bag shape as the medical container 10 of the present invention using a heat sealing machine (self-made machine). Sealing conditions are: mold temperature 270 ° C, sealing time 1
The operation time was 0 seconds and the cooling time was 30 seconds, and the operation time was much longer than that of Example 6. The finished aesthetic appearance of the seal was uneven because the surface of the port member was unevenly melted, and large burrs were generated under the condition of sealing without leakage, which was not satisfactory.
Table 1 shows the test results of the bonding strength of the bonded portions 9C and 9.
There were no particular problems in the centrifugation test and the autoclave resistance test.

(Comparative Example 7) The same sheet and port member 4 as in Example 7 were heat-sealed in the same bag shape as the medical container 10 of the present invention using a heat sealing machine (self-made machine). Sealing conditions are: mold temperature 280 ° C, sealing time 8
Second, the cooling time was 27 seconds, and the working time was much longer than that of Example 7. The finished aesthetic appearance of the seal was uneven because the surface of the port member was unevenly melted, and large burrs were generated under the condition of sealing without leakage, which was not satisfactory. Table 1 shows the test results of the bonding strength of the bonded portions 9C and 9. There were no particular problems in the centrifugation test and the autoclave resistance test.

(Comparative Example 8) The same sheet and port member 4 as in Example 8 were heat-sealed in the same bag shape as the medical container 10 of the present invention using a heat-sealing machine (self-made machine). Sealing conditions are: mold temperature 260 ° C, sealing time 1
The operation time was 0 seconds and the cooling time was 24 seconds, and the operation time was much longer than that in Example 6. The finished aesthetic appearance of the seal was uneven because the surface of the port member was unevenly melted, and large burrs were generated under the condition of sealing without leakage, which was not satisfactory.
Table 1 shows the test results of the bonding strength of the bonded portions 9C and 9.
There were no particular problems in the centrifugation test and the autoclave resistance test.

[0080]

[Table 1] In each of the examples and comparative examples, the adhesive strength test was performed using an autograph (20 mm between chucks, tensile speed 200 mm /
min, 23 ° C.), and the average value of each of the N samples was determined. All of the experimental results shown in Table 1 were not delamination of the adhesive interface but material destruction at the time of sealing.

[0081]

According to the method of manufacturing a medical container of the present invention, since a sealing method is employed by high-frequency dielectric heating for sealing a sheet by internally generating heat, the gap between the hollow port member and the film or sheet is eliminated. The following effects can be obtained: high adhesive strength, high adhesive strength between films and sheets, time required for heating and cooling, that is, short sealing time, and good finished appearance of the seal. According to the manufacturing method of the medical container of the present invention, since the high-frequency sealing conditions are appropriate,
With conventional high-frequency welding industrial equipment, it is not possible to generate heat internally by using high-frequency welding with a film or sheet composed of a halogen-free thermoplastic resin, etc. A medical container in which the port member is bonded with high bonding strength can be obtained. Since the medical container manufactured by the manufacturing method of the present invention is excellent without liquid leakage in a centrifugation test or an autoclave resistance test, for example, a bag for storing blood and blood components, bone marrow, lymph, and body fluids such as urine It is useful for a bag for storing a liquid, an infusion bag, a bag for storing nutrients for direct administration to a central vein, a bag for storing an enteral nutritional supplement, a bag for storing various chemical solutions, and the like.

[Brief description of the drawings]

FIG. 1 is a perspective view illustrating a reference example of a mold, a lower plate, and a core of a high-frequency welder used in the present invention.

FIG. 2 is a perspective view showing one reference example of a port member.

FIGS. 3A to 3E are explanatory views showing an example of a process for manufacturing the medical container of the present invention.

FIG. 4 is an explanatory view showing an example of a medical container manufactured by the manufacturing method of the present invention.

FIG. 5 is an enlarged sectional view of a main part of FIG.

FIG. 6 is an explanatory diagram illustrating a test method of adhesive strength.

[Explanation of symbols]

 Reference Signs List 1 mold (electrode) 2 lower plate (electrode) 3 core metal (electrode) 4 port member 4A, 4B concave portion 5A, 5B, 5C convex portion 6 hollow portion 7, 8 film or sheet 9, 9A, 9B, 9C adhesive portion 10, 10A Medical container 11 Cutter 12 Notch

────────────────────────────────────────────────── ─── Continuation of the front page (56) References JP-A-9-135880 (JP, A) JP-A-9-2427 (JP, A) JP-A-63-216570 (JP, A) (58) Field (Int.Cl. ⁷ , DB name) A61J 1/10 B29C 65/32 B32B 27/38

Claims (12)

(57) [Claims] 1. A method for producing a medical container comprising a thermoplastic resin sheet or film having a port member mounted thereon by a high-frequency dielectric heating method, comprising: (1) a mold (electrode) and a lower plate (electrode); The port member in which a sheet or film of the thermoplastic resin constituting the front and back surfaces of the medical container body is interposed between the core member and the core (electrode) inserted between the sheet or film of the thermoplastic resin. A first application step of sequentially applying a high-frequency voltage between the mold (electrode) or lower plate (electrode) and the core metal (electrode), (2) the mold (electrode) and the lower plate ( A second application step of applying a high-frequency voltage between the first container and the second electrode. 2. The first applying step comprises applying a high-frequency voltage between a lower plate (electrode) and a metal core (electrode) to bond the port member and a sheet or film on the lower plate (electrode) side. And thereafter applying a high-frequency voltage between the mold (electrode) and the core (electrode) to adhere the port member and the sheet or film on the mold (electrode) side. A method for manufacturing the medical container according to claim 1. 3. The medical device according to claim 1, wherein the second application step is performed after the first application step, and a predetermined portion of the sheet or the film is adhered to each other. Container manufacturing method. 4. The method for producing a medical container according to claim 1, wherein the thermoplastic resin sheet or film has a single-layer or multilayer structure. 5. The method for manufacturing a medical container according to claim 1, wherein the thermoplastic resin is a thermoplastic resin containing no halogen and having a dielectric constant of 2.3 or more. 6. The thermoplastic resin is polyethylene, polypropylene, polybutene, polybutadiene, polyisoprene, poly-4-methylpentene-1, polystyrene, polyvinyl acetate, polymethyl methacrylate, polyethyl methacrylate, polyacrylic acid. , Cyclic polyolefin, polyacrylonitrile, polyamide (nylon),
6. A homopolymer and / or a copolymer and / or a polymer blend containing at least one of the group consisting of polyester, polyurethane, polycarbonate, polyimide and polyphenylene sulfide. 4. The method for producing a medical container according to claim 1. 7. The method for manufacturing a medical container according to claim 1, wherein the thermoplastic resin is a thermoplastic elastomer and / or a polymer blend containing the thermoplastic elastomer. 8. The ethylene-α-olefin copolymer including ethylene-propylene copolymer, ethylene-butene copolymer, ethylene-hexene copolymer and ethylene-octene copolymer, wherein the copolymer is Ethylene-vinyl acetate copolymer, saponified ethylene-vinyl acetate copolymer, ethylene-acrylic acid copolymer, ethylene-ethyl acrylate copolymer, ethylene-methyl methacrylate copolymer, ethylene-maleic anhydride copolymer A block copolymer, a polyamide (nylon) -polyether composed of a polymer, an ionomer, a portion mainly composed of styrene and / or ethylene, and a portion composed of butadiene and / or isoprene and / or a hydrogenated product thereof; Block copolymer, polyester-polyether block copolymer, polyester-poly Ester block copolymers, polyether-based or polyester-based method for producing a medical container according to claim 6, characterized in that the polyurethane elastomer of the polycarbonate-based. 9. A block copolymer, wherein the thermoplastic resin comprises a portion composed mainly of styrene and / or ethylene, and a portion composed of butadiene and / or isoprene and / or a hydrogenated product thereof. The method for producing a medical container according to any one of claims 1 to 8, comprising a polymer blend with polypropylene and / or polyethylene and / or polybutene. 10. The sheet or film has a multilayer structure, and the innermost layer of the medical container is formed of a thermoplastic elastomer selected from polyamide elastomer, polyester elastomer, polyurethane elastomer and / or a polymer blend containing them. The method for producing a medical container according to any one of claims 4 to 8, wherein: 11. The medical container may be a bag for storing blood and blood components, a bag for storing body fluids such as bone marrow, lymph, and urine, an infusion bag, and a bag for storing nutrients for direct administration to a central vein or the like. The method for producing a medical container according to any one of claims 1 to 10, wherein the medical container is at least one of a bag for storing enteral nutrition, and a bag for storing various chemical solutions. 12. A medical container manufactured by the manufacturing method according to any one of claims 1 to 11.