JP2000254208A - Transfusion vessel - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a transfusion vessel in which a broken portion of the distribution restriction portion is exactly raised to chemicals surface and is not recognized as a foreign matter floated in the chemicals in the transfusion vessel in the transfusion vessel provided with a distribution restriction portion having a breakable portion and capable of carrying out a preparation and a formulation of drug to chemicals such as a transfusion in the inside. SOLUTION: This transfusion vessel 1 comprises a soft bag 2 in which chemicals are accommodated and a drug vessel 3 in which the drug is accommodated. The drug vessel 3 is provided with a drug housing portion 31; and a distribution restriction portion 4 comprising a breakable portion 41 capable of communicating the drug housing portion 31 with the chemicals housing portion at the inside of the soft bag 2 caused by a breakage at required and an operation portion for carrying out a breaking operation of the breakable portion 41. The operation portion 43 of the drug vessel 3 is separated from the distribution restriction portion after the breakable portion is broken and is formed to a hollow shape.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an infusion container in which a drug can be prepared or blended into a drug solution such as an infusion solution.

[0002]

2. Description of the Related Art Prior to infusion of a patient, a drug, such as a vitamin or an antibiotic, which is difficult to mix with the infusion in advance is mixed into a vial or a soft bag containing the infusion. It has been performed to dissolve and adjust the chemical solution. In the case of such a drug solution adjustment, in the case of a liquid drug, the dissolution solution is added and dissolved with a syringe in the case of a solid drug, and then the solution is sucked into a syringe and placed in a vial or a soft bag filled with an infusion solution. Injection is performed by mixing. However, such adjustment of the drug solution has a drawback that the operation procedure is complicated, and is particularly inconvenient when quick infusion is required. In addition, the above-mentioned adjustment of the drug solution may involve taking out a part of the infusion solution and mixing and dissolving the solution in another container, which may cause contact with a contaminated atmosphere or equipment. There was a risk of contamination.

In order to solve such a problem, Japanese Patent Application Laid-Open No. Hei 4-364851 discloses a medicine and a solution (infusion solution).
And a container in which the interior space of the container made of a soft bag is heat-sealed by a sealing portion to be separated into two, and the medicine and the solution are contained in each space. ing. When it is necessary to prepare a drug solution, the outside of the container is pressed to break the seal portion, and the drug and the solution are mixed.

[0004]

Since the entire container is made of a flexible sheet material, pinholes may be generated when pressure is applied from the outside of the container. When a pinhole is generated in this way, a gas, for example, moisture, oxygen, carbon dioxide, or the like in the air may enter from the pinhole, thereby altering the medicine in the container. Alternatively, the seal portion is easily broken by external pressure or impact, and the solution leaks out and mixes the drug and the solution except when necessary, thereby maintaining the stability and safety of the drug. It can be difficult.

[0005] Furthermore, since a flexible sheet material generally has a relatively high gas permeability, the gas comes into the space containing the drug from the dissolving solution or from the outside, so that the drug comes into contact with moisture, oxygen, etc. to be decomposed and decomposed. Deterioration may occur. Therefore, the portion of the container containing the medicine is double-wrapped with a gas-impermeable packaging material, and a deoxidizer or a desiccant is sealed inside the packaging material. However, wrapping only the part containing the drug with a packaging material or enclosing an oxygen scavenger or the like in this way complicates the manufacturing process and increases the bulk of the container, which is disadvantageous for transportation and storage. .

SUMMARY OF THE INVENTION An object of the present invention is to provide a transfusion container having a flow regulating portion having a breakable rupturable portion, in which a drug such as an infusion can be prepared or compounded with a drug solution. Is to provide an infusion container provided with a reliable flow control part.

[0007]

The above object is achieved by an infusion container comprising a soft bag containing a drug solution and a drug container containing a drug, wherein the drug container is a drug container. And a flow restricting portion including a breakable portion that allows the drug storage portion to communicate with the drug solution storage portion inside the soft bag by breaking when necessary, and an operation portion for performing a breaking operation of the breakable portion. Further, the operation part of the medicine container is a part which is separated from the flow restricting part after being broken by the breakable part, and the operation part is an infusion container formed hollow. The operation section is preferably formed in a color that can be identified with respect to the drug solution after the drug is mixed. Further, it is preferable that the operation unit is formed of a material having a color different from the color of the drug solution after mixing the drugs.

[0008]

DESCRIPTION OF THE PREFERRED EMBODIMENTS An infusion container according to the present invention will be described with reference to an embodiment shown in the drawings. FIG. 1 is a front view of an infusion container according to an embodiment of the present invention. FIG. 2 is an enlarged sectional view of the vicinity of a drug container of the infusion container of FIG. FIG. 3 is an explanatory view showing a state in which a flow restricting portion of the infusion container in FIG. 1 is broken.

The infusion container 1 of the present invention is a transfusion container comprising a soft bag 2 containing a drug solution and a drug container 3 containing a drug. The medicine container 3 includes a medicine container 31.
And a rupturable section 41 for allowing the medicine storage section 31 to communicate with the drug solution storage section inside the soft bag 2 by breaking with a finger or the like when necessary, and an operation section 43 for performing a rupture operation of the rupturable section 41. A regulating unit 4. further,
The operation part 43 of the medicine container 3 is
It is a part that is separated from the flow control part, and the operation part 43
Is formed hollow.

[0010] By forming the operating portion hollow, a hollow inner bottom portion close to the breakable portion is formed. By discharging the resin into the mold at the time of manufacturing from the portion that becomes the hollow inner bottom portion, the resin discharge gate and the breakable portion can be located close to each other, thereby forming a delicate thick breakable portion. The resin can reliably flow into the portion, and the flow restricting portion is provided with a breakable portion without thickness deviation as designed. If the operation part is not formed hollow, the gate position must be the side surface or the end surface of the flow control part, and a part close to and far away from the gate position is formed in the breakable part, which causes uneven thickness of the breakable part. Become. When uneven thickness occurs, a fragile portion is formed in the rupturable portion more than expected, and the risk of rupture during storage, transportation, or the like other than during use is increased.

The infusion container 1 of the present invention comprises a soft bag 2 and a medicine container 3 fixed thereto. Soft bag 2
Is a soft synthetic resin having a certain degree of heat resistance, for example, a polyolefin (for example, a mixture containing a polyolefin such as polyethylene, polypropylene, polybutadiene, an ethylene-propylene copolymer, a mixture of polypropylene and polyethylene or polybutene), and a partial cross-linking thereof. Products, ethylene-vinyl acetate copolymer (EVA), polyester (polyethylene terephthalate, polybutylene terephthalate, etc.), soft vinyl chloride resin, polyvinyl acetate, polyvinylidene chloride, silicone, polyurethane, polyamide elastomer, polyester elastomer, styrene / ethylene・ Various thermoplastic elastomers such as styrene-based elastomers such as butylene / styrene copolymer, or any combination of these (blended resin Polymer alloys, laminates, etc.)
And a multilayer structure comprising a resin layer of a hard material such as polyester such as polyethylene terephthalate and polyethylene naphthalate and a polyamide such as nylon and a resin layer of the above-described soft material (eg, polyethylene). Sheets are used. By being molded with these soft resins, the operation of connecting the drug solution storage unit and the drug storage unit 31 can be easily performed from outside the soft bag 2.

A preferable soft resin material is soft polyvinyl chloride. This soft polyvinyl chloride has heat resistance enough to withstand the high temperatures of autoclave sterilization, and is excellent in handleability due to its high flexibility. Further, there is an advantage that the molding and processing to the soft bag 2 and the fixation of the medicine container 3 by fusion are easy and the production cost can be reduced. Further, as a suitable constituent material of the soft bag 2, a soft resin softened by blending styrene-butadiene copolymer with polypropylene can be exemplified. This material is preferable because it is excellent in water resistance, heat resistance, flexibility, and workability, and can reduce the manufacturing cost. The thickness of the sheet material constituting the soft bag 2 is not particularly limited, and varies depending on the constituent materials of the sheets 2a and 2b. For example, in the case of a soft polyvinyl chloride sheet material, the thickness is preferably about 20 to 500 μm. The soft bag 2 has a tensile modulus of 50.
It is desirable to use an extruded film or an inflation-molded tube of 0 MPa or less, preferably 50 to 300 MPa.

The soft bag 2 is manufactured by blow molding using the above resin, the soft bag 2 is formed by welding peripheral portions of two sheets formed of the above resin,
One formed by folding one sheet made of the above resin and welding the peripheral portion, and one formed by welding the opening periphery of a cylindrical shape formed by extrusion molding using the above resin. May be.

A chemical solution storage section is formed inside the soft bag 2 and stores an infusion solution (chemical solution). Infusions include, for example, physiological saline, electrolyte solution, Ringer's solution, high calorie infusion, glucose solution, water for injection, amino acid electrolyte solution, and the like, but are not limited thereto.

The seal portion 2 on one end of the soft bag 2
3b is provided with a hole (suspended portion) 25 for hanging on a hanger or the like. Further, a film such as an aluminum foil may be laminated on the soft bag 2 to provide an oxygen barrier property, a light-shielding property, and the like for maintaining the quality of the chemical solution. Further, a thin film such as a vapor-deposited film made of an oxide such as titanium oxide, aluminum oxide, or silicon oxide may be formed on the surface of the soft bag 2 in order to impart oxygen barrier properties. Since these oxide films are transparent, the transparency of the soft bag 2 can be maintained, and the communication state when the operation of connecting the chemical solution storage unit and the drug storage unit 31 is performed can be confirmed, and the infusion agent ( This is preferable because the mixed / dissolved state of the drug solution and the drug can be easily visually recognized.

The soft bag 2 has a fixing portion 22 for fixing the medicine container 3. The medicine container 3 is fixed to a fixing portion 22 which is an opening of the soft bag 2. The medicine container 3 has a hollow main body part (medicine storage part forming part) 32.
And a flow restricting portion 4 for closing one end (tip) of the hollow main body portion
And an elastic body (plug) 61 for closing the other end (opening) of the hollow main body, and a cap 6 for covering the outer periphery of the elastic body 61
2 is provided.

The medicine container 3 includes a medicine container joining member 5 provided between the medicine container 3 and the opening of the soft bag 2.
Thereby, it is liquid-tightly fixed to the soft bag 2. As shown in FIG. 2, the flow restricting portion 4 includes a hollow operating portion 43, the operating portion 43, a breakable portion 41 provided between the operating portion and the hollow main body 32, The liquid supply section 44 provided in the section 32 is provided. The liquid passage section 44
Although two are provided so as to face each other, the present invention is not limited to this, and about 1 to 8 are preferable. By providing the liquid passage portion, it is possible to prevent the chemical solution from remaining in the hollow main body portion.

The breakable portion 41 is a portion where a wedge-shaped annular concave portion is formed, and is thinner than other portions. For this reason, the breakable portion 41 is more fragile than the other portions, and when the operating portion 43 is pushed from the outside of the bag, the breakable portion 41 breaks at the breakable portion 41 and the operating portion 43
Is separated from the distribution control section (main body section). By forming the separated operation portion 43 in a hollow shape, the breakable portion 41 is in a state without uneven thickness. Hollow body 32
The distance between the inner bottom surface 33 and the breakable portion 41 is 1-2 mm
It is preferred that

Further, the operation section 43 may be formed in a color that can be identified with respect to the drug solution after mixing the drugs. It can be easily distinguished from the chemical solution, and since it floats on the surface of the chemical solution, it is easy to check the remaining amount of the chemical solution. The color that can be identified with respect to the drug solution after the drug mixture differs depending on the drug solution and the drug used and is not unique. For example, if the color of the drug solution after the drug mixture is yellow, other than yellow (for example, , Red, blue, green,
If black) is red, it is other than red (for example, yellow, blue, green, black). If the color of the drug solution after mixing the drugs is colorless, any color may be used as long as it is colored.

It is preferable that the medicine container 31 of the medicine container 3 contains an appropriate amount of medicine, and that the medicine inside the medicine container 31 is transparent so that the medicine inside can be seen. The medicine to be stored may be in any form such as a solid such as a powder or a granule, or a liquid. As a drug,
It is compounded and dissolved in an infusion solution, for example, antibiotics, vitamins (multivitamins), various amino acids, antithrombotics such as heparin, insulin, antitumor agents, analgesics, inotropic agents, intravenous anesthetics, Examples include antiparkinson agents, ulcer treatment agents, corticosteroid agents, arrhythmic agents, correction electrolytes, antiviral agents, immunostimulants and the like. The medicine container 31 of the medicine container 3 may be at normal pressure, or may be under reduced pressure or vacuum. As described above, when the medicine storage section 31 is in a decompressed or vacuum state, the effect of preventing deterioration, degradation, and the like of the medicine is improved, and when the breakable section 41 is ruptured, the infusion solution is sucked and the medicine is more quickly squeezed. It can be introduced into the storage section 31.

The medicine container 31 has a sufficient capacity for accommodating a medicine and for introducing and dissolving and mixing an infusion solution. The flow restricting portion 4 protrudes inside the soft bag 2 (inside the chemical solution storage portion). In addition, the soft bag 2
A fixing section 22 for fixing the medicine container 3 is provided.

The main body 32 of the medicine container 3 and the flow regulating part 4 may be formed by joining separate members, or may be formed integrally as in this embodiment. In particular, it is formed of a separate member around a portion corresponding to the rupturable portion 41, and a portion on the tip side (operation portion 43) of the rupturable portion is formed of a material that can be distinguished from the color of the drug solution after mixing the drugs. May be. Further, in this case, the breakable portion 41
The breakable portion 4 is formed by interposing a brittle resin
1 may be formed.

It is preferable that the main body 32 and the flow restricting portion 4 of the medicine container 3 are made of a hard material, particularly a hard resin material. Further, by using a hard material, the breakable portion 41 can be easily and reliably broken by operating the operation portion 43. In addition, medicine container 3
It is preferable that at least the hollow main body portion 32 is made of a transparent or translucent material in order to secure the visibility of the inside.

The transparent hard material used for the drug container 3 preferably has a haze value (haze ratio) of 75% or less. Examples of the resin used for the drug container 3 include hard polyvinyl chloride, polyethylene, polypropylene, polybutadiene, and cyclic polyolefin (specifically, ZEONEX (manufactured by Zeon Corporation), APAL
(Manufactured by Mitsui Chemicals, Inc.)), polypropylene homopolymer, polyolefin such as high-density polyethylene, polystyrene, poly- (4-methylpentene-1), polycarbonate, ABS resin, acrylic resin, polymethyl methacrylate (PMMA), polyacetal , Polyarylate, polyacrylonitrile, polyvinylidene fluoride, ionomer, acrylonitrile-butadiene-styrene copolymer, polyethylene terephthalate (PE
T), various resins such as polyesters such as polybutylene terephthalate, butadiene-styrene copolymers, aromatic or aliphatic polyamides, and any combination thereof. Among them, in terms of high safety and excellent adhesion to the soft bag 2,
Rigid polyvinyl chloride, polyethylene, polypropylene,
Polyester is preferred.

The medicine container 3 is used to concentrate stress for destruction on the rupturable portion 41 and to maintain the shape of the connection portion with the flexible bag 2 with respect to the bag 2.
Preferably, it is made relatively rigid so that large deformations cannot be tolerated. However, the thickness of the container wall is increased so that deformation stress for destruction is easily concentrated on the breakable portion 41 and the operation portion 43, or the operation portion 4
By designing the structure other than the portion 3 to be hardly deformed, the same soft material as the soft bag 2 can be used.

The medicine container 3 comprises a medicine container joining member 5 provided between the medicine container 3 and the opening of the soft bag 2.
Thereby, it is liquid-tightly fixed to the soft bag 2. The medicine container joining member 5 is a cylindrical member formed of a material that can be bonded (heat-fused) to both the medicine container forming material and the soft bag forming material. The medicine container joining member 5 can house the main body 32 of the medicine container 3 therein. A portion of the medicine container joining member 5 exposed to the outside of the soft bag 2 is an enlarged diameter portion.

The material for forming the medicine container joining member 5 is preferably a soft transparent resin, which is a material for forming the soft bag 2 described above, or a transparent hard material, which is a material for forming the medicine container 3 described above. , Cloudiness value (haze rate) is 7
It is preferably at most 5%. The material for forming the medicine container joining member 5 is preferably a material that can be thermally fused to the soft bag 2 and the medicine container 3. When the soft bag 2 and the medicine container 3 are formed of different materials, the medicine container joining member 5 uses a material having high heat-fusibility with the soft bag 2 as an outer layer, and It may be a multilayer structure having a material having a high heat-sealing property as an inner layer. Specifically, polypropylene and polyethylene are common.

The medicine container 3 may be directly fixed to the soft bag 2 without providing the medicine container joining member 5. In this case, the contact portion of the medicine container 3 with the soft bag 2 is formed of a resin having high compatibility (thermal fusion property) with the material forming the soft bag 2 by a method such as two-color molding or insert molding. Is preferred. The fixing of the medicine container 3 to the soft bag 2 can be performed by physical fixing such as fitting, chemical fixing such as high-frequency sealing, heat sealing, or the like. In case of high frequency seal or heat seal,
It is necessary to select a material that can be fused on the heat-sealed surfaces of both containers, vinyl chloride resin is suitable for high-frequency sealing, and polypropylene or a mixture of polypropylene and various resins is also possible. Mixtures with resins, various resins and elastomers and multilayer structures are preferred. In addition, if it is formed of a material having flexibility such as an elastic material, fusion can be performed more reliably by pressing with a mold at the time of sealing.

The medicine container 3 is indirectly or directly sandwiched between the sheet materials at the fixing portion 22 of the soft bag 2 and is fixed by being fused. For this reason, the medicine container 3 can be easily and reliably fixed to the soft bag 2, and since the bonding property and the adhesion property (sealing property) of the two are high, liquid leakage and the like can be reliably prevented. .

A discharge port for discharging a chemical solution (liquid) is provided at an open end of the medicine container 3 (an end opposite to the flow regulating portion 4). This outlet has an elastic body 61 made of an elastic material. The elastic body 61 is attached to the medicine container joining member 5 by a cap (elastic body supporting member) 62 from above.
And it is fixed to the open end of the medicine container 3.

The elastic body 61 can penetrate a needle tube (not shown), and can penetrate the needle tube as needed to inject the drug solution in the infusion container 1. Further, the elastic body 61 has a self-closing property, and after the needle tube is pulled out from the elastic body 61, the puncture hole is closed to prevent leakage of the drug solution. As a constituent material of the elastic body 61, a polymer material having flexibility is preferable. For example, polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, cross-linked ethylene-vinyl acetate copolymer Such as thermoplastic resins (thermoplastic elastomers) such as polyolefin, polyester, polyvinyl chloride, polyurethane, polyamide, polyamide elastomer, polyester elastomer, etc., natural rubber, isoprene rubber, silicone rubber, butadiene rubber, and styrene-butadiene rubber. An elastic material such as a rubber material or a combination of any two or more of these materials can be used.

The cap 62 has a ring shape and is fixed to the opening end of the medicine container 31 by, for example, screwing, fitting, caulking, bonding, fusion, or the like. The material of the cap 62 is not particularly limited, and examples thereof include various resin materials and metal materials.

The medicine container 3 is indirectly or directly sandwiched between the sheet materials at the sealing portion 23a of the soft bag 2, and is fixed by being fused. For this reason, the medicine container 3 can be easily and reliably fixed to the soft bag 2, and since the bonding property and the adhesion property (sealing property) of the two are high, liquid leakage and the like can be reliably prevented. .

FIG. 3 is an explanatory view showing a state in which the flow restricting portion 4 of the infusion container 1 of FIG. 1 is broken. By folding the breakable portion 41 from the outside of the soft bag 2 with a finger, the infusion solution contained in the soft bag 2 and the drug contained in the drug container 3 are mixed, and the operation can be performed quickly and efficiently. It can be carried out.

[0035]

The container for infusion according to the present invention is a container for infusion comprising a soft bag containing a drug solution and a drug container containing a drug. A breakable part that allows the medicine storage part to communicate with the medicine storage part inside the soft bag due to breakage at the time, and a flow regulating part including an operation part for performing a breaking operation of the breakable part, further comprising: The operation part of the medicine container is a part that is separated from the flow restricting part after being broken by the breakable part, and the operation part is formed hollow.

By forming the operating portion hollow, a hollow inner bottom portion close to the breakable portion is formed. By discharging the resin into the mold at the time of manufacturing from the portion that becomes the hollow inner bottom portion, the resin discharge gate and the breakable portion can be located close to each other, thereby forming a delicate thick breakable portion. The resin can reliably flow into the portion, and the flow restricting portion is provided with a breakable portion without thickness deviation as designed. If the operation part is not formed hollow, the gate position must be the side surface or the end surface of the flow control part, and a part close to and far away from the gate position is formed in the breakable part, which causes uneven thickness of the breakable part. Become. Since uneven thickness is unlikely to occur, a fragile portion is not formed more than expected in the breakable portion, and the risk of breakage during storage, transportation, or the like other than during use is low.

Further, if the operating portion is formed in a color that can be identified with respect to the drug solution after mixing the drug, the operating portion can be easily distinguished from the drug solution, and the operating portion floats on the surface of the drug solution, so that the remaining amount of the drug solution can be easily confirmed. Becomes

[Brief description of the drawings]

FIG. 1 is a front view of an infusion container according to an embodiment of the present invention.

FIG. 2 is an enlarged sectional view of the vicinity of a medicine container of the infusion container of FIG. 1;

FIG. 3 is an explanatory view showing a state in which a flow restricting portion of the infusion container in FIG. 1 is broken.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Infusion container 2 Soft bag 3 Drug container 4 Flow control part 31 Drug storage part 41 Breakable part 43 Operation part

 ────────────────────────────────────────────────── ─── Continued on the front page F term (reference) 3E067 AA03 AA05 AB81 AC06 BA12A BA31A BB12A BB14A BB15A BB16A BB25A CA11 CA12 CA17 CA24 EA06 EB01 EB02 EE15

Claims (3)

[Claims] 1. An infusion container comprising a soft bag containing a drug solution and a drug container containing a drug, wherein the drug container has a drug storage portion and a drug storage portion which is broken when necessary. A breakable portion that can communicate with the drug solution storage portion inside the soft bag and a flow regulating portion including an operation portion for performing a breaking operation of the breakable portion, and further, the operation portion of the drug container, An infusion container, which is a part that is separated from the flow restricting part after being broken by the breakable part, and wherein the operation part is formed in a hollow. 2. The infusion container according to claim 1, wherein the operation section is formed in a color that can be identified with respect to the drug solution after the drug is mixed. 3. The operation section is made of a material having a color different from the color of the drug solution after mixing the drugs.
Or the infusion container according to 2.