WO2012118115A1

WO2012118115A1 - Drug storage container

Info

Publication number: WO2012118115A1
Application number: PCT/JP2012/055062
Authority: WO
Inventors: 平沼　隆明; 正臣今井
Original assignee: テルモ株式会社
Priority date: 2011-03-03
Filing date: 2012-02-29
Publication date: 2012-09-07
Also published as: JP5963741B2; JPWO2012118115A1

Abstract

The drug storage container is configured from a hollow container body, a cover member that covers the container body, a sheet that is fitted on the base of the cover member, and a powdered drug that is stored inside the container body. The container body is configured from a cylindrical barrel and a mouth that is provided on the tip of the barrel. The barrel is provided with a deformation-resistant part that does not deform or is difficult to deform when a solubilizing liquid is filled into the storage space, and an easily deforming part that increases the volume of the storage space by deforming. The drug is dissolved by a solubilizing liquid that is filled from a syringe, etc. through the mouth of the container body.

Description

Drug storage container

The present invention relates to a medicine container.

Conventionally, a powder drug for injection is formulated by placing a liquid drug in a container such as glass and freeze-drying it on a flat plate under vacuum (for example, see Patent Document 1). In the medical container described in Patent Document 1, when such a powder drug for injection is dissolved, the solution is added into the vial using a syringe or the like, but the solution is added to the sealed container. Along with this, the internal pressure in the container has increased, and as a result, a risk has been pointed out that some drugs are ejected outside the container and contaminate the person in charge of dispensing (aerosol phenomenon).

Such contamination by ejected drugs is particularly problematic for hazard drugs represented by anticancer drugs. That is, there is a concern that the drug sprayed by the pressure increase in the container is applied to the person in charge of the dispensing, thereby causing serious cytotoxic problems such as skin corrosion and diffuseness.

In order to avoid such a risk at the time of dispensing, until now, when dissolving a highly hazardous drug, it is necessary to perform a complicated operation such as adding a solution to the container while adjusting the pressure in the container by pumping the syringe. It was done. “Pumping operation” refers to the operation of pulling the pusher to make the negative pressure inside the container after connecting the syringe containing the dissolved liquid, releasing the pusher, and adding the solution of the pressure change into the container Is an operation of adding the solution into the container.

Furthermore, it has been pointed out that in the case of conventional vials, there is a risk that the drug will adhere to the outer surface of the vial when the drug is filled, and the surroundings of the vial may be contaminated with the drug during transportation, storage, and use.

JP-A-8-131514

An object of the present invention is to eliminate a complicated pumping operation by relieving the pressure increase inside the container by the easily deformable portion when the drug is dissolved, and by covering the container body with a cover member, An object of the present invention is to provide a medicine container that can prevent contamination to the surroundings by medicine attached to the outer surface of a main body.

In order to achieve the above object, the present invention provides:
A mouth part provided at the tip part and allowing liquid to enter and exit;
A container body provided on the proximal end side of the mouth, and including a trunk having a storage space for storing a medicine;
The trunk portion connects a bottom portion provided on the opposite side of the mouth portion, the bottom portion and the mouth portion, and does not deform when the storage space is filled with the liquid via the mouth portion. Or a hard-to-deform part that is difficult to deform, and an easy-to-deform part that increases the volume of the storage space by being deformed,
A cover member is provided outside the container main body so as to cover at least the easily deformable portion and to form a deformation space for the deformable portion to be deformed, and is harder than the easily deformable portion. And a medicine container.

Moreover, in the medicine container according to the present invention, it is preferable that the difficultly deformable portion and the easily deformable portion are formed of separate members and are joined to each other.

In the drug storage container of the present invention, it is preferable that at least a surface of the container main body facing the storage space is made of a low adsorptive material with little adsorption of the drug.

In the drug container according to the present invention, it is preferable that the low adsorptive material is mainly composed of cyclic polyolefin.

Moreover, in the medicine container of the present invention, the hardly deformable portion is substantially entirely composed of the low adsorptive material,
The easily deformable portion is provided facing the storage space, and is provided with an inner layer made of the low adsorptive material, and an outer layer that is provided on the opposite side of the inner layer from the storage space and reinforces the inner layer. It is preferable to have.

In the medicine container according to the present invention, the cover member has an opening at the tip, a bottom at the base, and a cylindrical main body that covers substantially the entire body, and the main body It is preferable to have a lid portion that is detachably mounted and covers the mouth portion.

In the medicine container of the present invention, the container main body detachment preventing member is provided for preventing the container main body from being detached from the main body portion of the cover member when the container main body is stored in the main body portion of the cover member. Is preferred.

In the medicine container according to the present invention, the container main body detachment preventing member includes a fixing portion that is fixed to the opening of the cover member and an engaging portion that engages with the container main body from the distal end side. preferable.

Moreover, in the medicine container of the present invention, the main body of the cover member has a bottomed cylindrical shape,
It is preferable that the container main body detachment preventing member has a rotation preventing portion that prevents the container main body from rotating with respect to the main body portion of the cover member when the container main body is housed in the main body portion of the cover member.

In the medicine container according to the present invention, the difficultly deformable portion includes a first wall portion in which a large opening portion is formed and the easily deformable portion is joined so as to seal the large opening portion. And connecting the end portions of the wall portion parallel to the axial direction of the cover member, and having a second wall portion curved along the inner peripheral surface of the cover member,
The container main body detachment preventing member has a ring shape, and has a projecting piece that protrudes on an inner peripheral portion thereof and is provided with an abutting portion that abuts on the first wall portion,
It is preferable that the rotation preventing portion is composed of the protruding piece.

Moreover, in the medicine container according to the present invention, it is preferable to include an easily deformable portion detachment preventing member that prevents the easily deformable portion from being detached from the hardly deformable portion.

FIG. 1 is a perspective view showing an initial state of a medicine container (first embodiment) of the present invention. FIG. 2 is an exploded perspective view of the medicine container shown in FIG. FIG. 3 is a perspective view showing a state in which the container main body in the medicine container shown in FIG. 4 is a cross-sectional view taken along line AA in FIG. FIG. 5 is a cross-sectional view taken along line BB in FIG. FIG. 6 is a longitudinal sectional view showing an initial state of the medicine container (second embodiment) of the present invention. FIG. 7 is a longitudinal section showing an initial state of the medicine container (third embodiment) of the present invention. FIG. 8 is a longitudinal cross-sectional view showing a state in which the solution is filled in the medicine container shown in FIG. FIG. 9 is a perspective view showing an easily deformable portion detachment preventing member provided in the medicine container shown in FIG. FIG. 10 is a diagram for sequentially explaining the assembly process of the medicine container shown in FIG. FIG. 11 is a diagram for sequentially explaining the assembly process of the medicine container shown in FIG. 7. FIG. 12 is a view for sequentially explaining the assembly process of the medicine container shown in FIG.

Hereinafter, the medicine container of the present invention will be described in detail based on a preferred embodiment shown in the accompanying drawings.

<First Embodiment>
1 is a perspective view showing an initial state of a medicine container (first embodiment) according to the present invention, FIG. 2 is an exploded perspective view of the medicine container shown in FIG. 1, and FIG. 3 is a medicine container shown in FIG. FIG. 4 is a cross-sectional view taken along line AA in FIG. 1, and FIG. 5 is a cross-sectional view taken along line BB in FIG.

In the following, for convenience of explanation, the upper side in FIGS. 1 to 12 is referred to as “tip”, “up” or “upper”, and the lower side is referred to as “base”, “lower” or “lower”.

A drug storage container 1 shown in FIG. 1 is stored in a container body 2, a hollow container body 2, a cover member 8 that covers the container body 2, a sheet material 9 attached to the base end of the cover member 8, and the container body 2. It consists of powdered medicine Q.

The medicine Q is stored in the container body 2 in advance in the initial state (unused state) of the medicine storage container 1 shown in FIGS. This medicine Q is dissolved by, for example, a solution R filled from a syringe (not shown) through the mouth portion 7 of the container body 2. Hereinafter, the drug Q dissolved in the solution R is referred to as “medical solution P”. The state shown in FIGS. 3 and 5 in which the container body 2 is filled with the solution R is referred to as a “solution-filled state”.

The container main body 2 is composed of a cylindrical barrel portion 3 and a mouth portion 7 provided on the distal end side of the barrel portion 3. The body portion 3 is provided with a bottom portion 4 so as to close the base end opening (opening on the side opposite to the mouth portion 7). Moreover, the internal space of the trunk | drum 3 is the storage space 31 in which the chemical | medical agent Q is stored.

In the following explanation, unless otherwise specified, it refers to the “initial state”. The volume of the storage space 31 in the initial state is not particularly limited, but is preferably 5 to 80 mL, for example, and more preferably 10 to 50 mL.

When the storage space 31 is filled with the dissolution liquid R, the body portion 3 is not easily deformed or hardly deformed (hard portion) 32, and an easily deformable portion that increases the volume of the storage space 31 by being deformed. (Reversing part) 33. Moreover, in the trunk | drum 3, the hardly deformable part 32 occupies most and the easily deformable part 33 occupies the remaining part.

In the present embodiment, the hardly deformable portion 32 and the easily deformable portion 33 are configured as separate members, and are joined to each other by, for example, fusion, bonding with an adhesive, or the like. By setting it as this structure, the structure and constituent material of each part can be selected so that the hard deformation part 32 and the easy deformation part 33 can exhibit those functions reliably.

The hardly deformable portion 32 is a portion having a function of connecting the bottom portion 4 and the mouth portion 7, and connects the flat plate-like first wall portion 32a and the left side and the right side of the first wall portion 32a, that is, A second wall portion 32b that is curved along the inner peripheral surface of the cover member 8 is formed integrally with the ends of the cover member 8 that are parallel to the axial direction. Accordingly, the outer shape of the hard-to-deform portion 32 in a top view (or a bottom view) is a D-shape. In addition, the 1st wall part 32a and the 2nd wall part 32b should just be formed so that the external shape in the top view (or bottom view) of the hard deformation part 32 may become a closed shape. Therefore, the second wall portion 32b may have a U-shape, for example, when viewed from above (or from below).

A large opening 320 is formed at the center of the first wall 32a. The easily deformable portion 33 is inserted into the large opening 320, and an edge serving as the joint portion 330 of the easily deformable portion 33 is bonded and fixed to the outer surface of the first wall portion 32a. That is, the easily deformable portion 33 is joined so as to seal the large opening 320.

The hard deformation portion 32 is made of a hard material so as to be hard to be deformed as much as possible. Examples of such hard materials include cyclic polyolefins such as cycloolefin polymer (COP) and cycloolefin copolymer (COC), polyolefins such as polyethylene and polypropylene, polyvinyl chloride, polystyrene, poly- (4-methylpentene-1 ), Polycarbonate, acrylic resin, various resin materials such as polyester such as polyethylene terephthalate and polyethylene naphthalate, various metal materials, and various ceramic materials. Among them, various resins are used from the viewpoint of ensuring internal visibility. Materials are preferred, and cyclic polyolefins, polyolefins or polyesters are more preferred. This is because these resin materials are easy to mold and have high gas barrier properties.

Further, depending on the nature of the inner surface of the hard-to-deform portion 32 (the surface facing the storage space 31), the drug Q may adhere (adsorb or the like) to the inner surface. In this case, the concentration of the drug Q in the drug solution P taken out from the drug container 1 is lower than the target concentration. Therefore, it is preferable that the hardly deformable portion 32 is made of a material to which the drug Q is difficult to adhere, that is, a low adsorptive material with little drug Q adsorption. Examples of the low adsorptive material include cyclic polyolefin.

When comprehensively considering the above, it is preferable that the constituent material of the hardly deformable portion 32 is mainly composed of cyclic polyolefin. In particular, since the cyclic polyolefin has a low protein adsorptivity, the drug storage container 1 is optimal for a container that stores a protein preparation (including a peptide preparation) as the drug Q.

The thickness of the hardly deformable portion 32 is not particularly limited, but is preferably about 0.5 to 2.5 mm, and more preferably about 0.8 to 1.5 mm. Thereby, sufficient intensity | strength can be ensured to such an extent that it does not deform | transform or it is hard to deform | transform, when the storage space 31 is filled with the solution R, maintaining the transparency (translucency) of the hardly deformable part 32. .

In addition, from the viewpoint of preventing the drug Q from adhering, only the vicinity of the inner surface of the hardly deformable portion 32 may be made of the above-described low adsorptive material.

The difficultly deformable portion 32 is manufactured by joining the shoulder portion 34 and the body portion 3 that are separately injection-molded by means such as welding.

The easily deformable portion 33 is fixed to the hardly deformable portion 32. The easily deformable portion 33 has a bowl shape as a whole, and an annular joint portion 330 is formed along the edge portion. In the joint portion 330, the easily deformable portion 33 is joined and fixed to the hardly deformable portion 32.

As shown in FIG. 4, the easily deformable portion 33 is positioned above the medicine Q in the standing state in which the medicine container 1 stands. Thereby, since the freeze-dried medicine Q is in the hardly deformable portion 32, it is possible to prevent the medicine Q from collapsing due to vibration or contact during transportation. In addition, since there is the medicine Q filled in the bottom surface (bottom 4) of the hardly deformable portion 32 during freeze-drying, there is an advantage that the thermal conductivity from the cooling shelf to the medicine Q is improved.

As shown in FIGS. 4 and 5, the thickness of the easily deformable portion 33 is formed to be thinner than the thickness of the hardly deformable portion 32. Thereby, when the storage space 31 is filled with the dissolution liquid R, the hardly deformable portion 32 is not deformed or hardly deformed, and the easily deformable portion 33 is deformed. That is, when the storage space 31 is filled with the dissolution liquid R, the easily deformable portion 33 is configured to be deformed with priority over the hardly deformable portion 32.

The easily deformable portion 33 includes an inner layer 331 provided facing the storage space 31 and an outer layer 332 joined to the outside of the inner layer 331 (on the side opposite to the storage space 31).

From the viewpoint of preventing the drug Q from adhering to the inner surface (the surface facing the storage space 31) of the easily deformable portion 33, the inner layer 331 is preferably made of a low adsorptive material. Thereby, the chemical | medical solution P containing the chemical | medical agent Q with the target density | concentration can be taken out from the chemical | medical agent storage container 1. FIG.

In this case, since the low adsorptive material (particularly cyclic polyolefin) has relatively low toughness, depending on the injection rate of the solution R into the storage space 31, etc. The layer 331 may be wrinkled, cracked, or cracked.

Therefore, an outer layer 332 that is bonded to the inner layer 331 and reinforces the inner layer 331 is provided. Therefore, it is preferable that the outer layer 332 has high toughness even when it is formed thin so that the easily deformable portion 33 can be easily deformed (so that sufficient flexibility can be maintained).

Examples of the constituent material of the outer layer 332 include polyolefins such as polyethylene and polypropylene, modified polyolefins, various thermoplastic resins such as polyvinyl chloride, polyvinylidene chloride, and polystyrene.

The thickness of the easily deformable portion 33, that is, the total thickness of the inner layer 331 and the outer layer 332 is not particularly limited, but is preferably about 50 to 300 μm, more preferably about 100 to 200 μm. . Thereby, the easily deformable part 33 can have high flexibility (softness | flexibility), maintaining sufficient intensity | strength.

The thickness of the inner layer 331 is not particularly limited, but is preferably about 5 to 80 μm, and more preferably about 5 to 50 μm.

Note that one or more arbitrary layers may be provided between the inner layer 331 and the outer layer 332. Examples of such purposes include the purpose of improving the adhesion between the inner layer 331 and the outer layer 332, the purpose of improving the gas barrier property (water vapor permeability) of the easily deformable portion 33 as a whole, and the like.

In addition, when a material having sufficient strength and flexibility and capable of reducing the affinity for the medicine Q is selected, the easily deformable portion 33 can be configured by one layer (one member). . In this case, the easily deformable portion 33 and the hardly deformable portion 32 may be integrally formed by, for example, blow molding.

The mouth portion 7 for injecting the solution R into the storage space 31 and discharging the chemical solution P from the storage space 31 is disposed at the front end portion of the container body 2. As shown in FIGS. 4 and 5, the mouth portion 7 is provided with a valve element 5 made of an elastic material and having a self-occlusion property. Instead of the valve body 5, a rubber stopper or the like that can be punctured with a needle may be used.

The mouth portion 7 includes a cylindrical portion 72 formed in a cylindrical shape and a mouth lid portion 73 attached to the cylindrical portion 72 while reducing the diameter of the distal end portion of the hardly deformable portion 32 of the body portion 3. ing.

As shown in FIGS. 4 and 5, the tubular portion 72 has a valve body installation portion 721 formed therein. The valve body setting portion 721 is divided into a second lumen portion 723 and a third lumen portion 724 that is located on the proximal end side and is smaller in diameter than the inner diameter of the second lumen portion 723. be able to. Moreover, it is preferable that the internal diameter of the 3rd lumen | bore part 724 is a little larger than the largest outer diameter of the trunk | drum 55 of the valve body 5 mentioned later.

Also, an inner protrusion 725 made of a tubular body is provided at the center of the bottom surface 722 of the cylindrical portion 72. When the syringe is connected to the mouth portion 7 and the valve body 5 starts to be pressed downward, the internal protrusion 725 supports the inside of the valve body 5 and causes the valve body 5 to buckle. Can be prevented. Further, when the solution R passes through the mouth portion 7, it is possible to prevent the solution R from staying.

The mouth lid portion 73 has a lumen portion for accommodating the valve body 5 therein, and is connected to the tubular portion 72. The mouth lid portion 73 is made of, for example, a hard resin material.

Inside the mouth lid portion 73, a first lumen portion 731 into which a later-described head portion 50 of the valve body 5 can be inserted, and a first lumen portion 731 communicate with the first lumen portion 731. A fitting portion 733 having a diameter larger than 731 is formed.

The first lumen portion 731 is formed so that its shape corresponds to the outer shape of the head 50 of the valve body 5.

Further, the fitting part 733 is a part that fits to the outer peripheral part of the cylindrical part 72. Thereby, the lid part 73 for mouth parts and the cylindrical part 72 are connected in a liquid-tight manner, and thus the solution R inside the mouth part 7 leaks from between the lid part 73 for mouth parts and the cylindrical part 72. Can be prevented. In addition, when the mouth lid portion 73 and the tubular portion 72 are connected, the first lumen portion 731 and the second lumen portion 723 communicate with each other, and the first lumen portion 731 and the second lumen portion 723 communicate with each other. The valve body 5 can be installed in a space formed by the lumen portion 723 and the third lumen portion 724.

A male screw portion 738 is formed on the outer peripheral portion of the mouth lid portion 73. The male screw portion 738 is a portion that is screwed with the syringe when the syringe is connected to the mouth portion 7.

In the mouth portion 7 having such a configuration, the inner lumen functions as a flow path through which the solution R can pass.

As shown in FIGS. 4 and 5, the valve body 5 is installed in the mouth portion 7. Examples of the constituent material of the valve body 5 include various rubber materials such as isoprene rubber, and various thermoplastic elastomers such as polyolefin. By using such an elastic material, moderate elasticity can be obtained on the tip surface 511 of the valve body 5. Thereby, when a syringe is connected to the mouth part 7, the end surface of the said syringe and the front end surface 511 can adhere | attach liquid-tightly.

The valve body 5 includes a tubular body portion 55 and a head portion 50 provided integrally with one end portion of the body portion 55.

The head 50 has a bottomed cylindrical shape, and can be opened and closed by reaching the lumen 515 from the lumen portion 515 through which the solution R and the drug solution P can pass, and the flat distal end surface 511. A slit 512 is formed as an open / close portion.

The slit 512 has a substantially single character shape. Since the shape of the slit 512 is so simple, the front end surface 511 is deformed when the vicinity of the slit 512 of the front end surface 511 is pressed, and thus the slit 512 is reliably opened. Further, when the pressing is released, the front end surface 511 is restored, so that the slit 512 is reliably closed. Thus, the valve body 5 has a self-occlusion property.

In addition, by the operation of the slit 512, the mouth portion 7 can be easily and reliably sealed / unsealed.

Further, when the pressing force as described above is not applied, the head 50 is inserted into the first lumen 731 of the mouth lid 73 and the slit 512 is closed.

The trunk portion 55 is formed of a cylindrical body having a bellows shape. That is, the body 55 has a bellows shape in which the large-diameter ring portion 552 and the small-diameter ring portion 553 are alternately arranged in the axial direction in the outer shape. Such a body portion 55 functions as a deforming portion that urges the head portion 50 in a direction in which the head portion 50 is inserted into the first lumen portion 731 of the mouth portion lid portion 73.

On the other hand, the base end opening of the body part 3 on the side opposite to the mouth part 7 is closed by the bottom part 4 formed integrally with the hardly deformable part 32 of the body part 3.

The medicine Q is stored in the storage space 31 defined by the body 3 having such a configuration. The drug Q is not particularly limited. For example, anti-cancer drugs, immunosuppressive drugs, etc., which need to be dissolved in the use of drugs that are dangerous to medical personnel, antibiotics, hemostatic agents, hormone preparations, etc. And drugs that require dilution, such as drugs for children, vaccines, heparin, drugs for children, etc.

Further, the solution R for dissolving the drug Q is filled in the drug container 1 using a syringe as described above. As the solution R, for example, physiological saline can be used.

1 and 4, the container body 2 is covered with a cover member 8. A small hole (communication hole 831) is formed in the center of the bottom 83 of the cover member 8, and the communication hole 831 is covered with the sheet material 9. In other words, the container body 2 is accommodated in a space defined by the cover member 8 and the sheet material 9. The communication hole 831 may be formed on the side surface of the cover member 8.

Further, the communication hole 831 may be provided with a filter having a function of allowing gas to pass but not liquid and solid. As a result, as will be described later, even after the sheet material 9 is removed to open the deformation space 810, the possibility that the drug Q attached to the outer surface of the container body 2 scatters through the communication hole 831 can be eliminated. The filter preferably has a hydrophobic surface or a hydrophobic membrane (hydrophobic membrane). Examples of the constituent material of the hydrophobic film include polytetrafluoroethylene (PTFE), a copolymer of tetrafluoroethylene and hexafluoropropylene (FEP), and a copolymer of tetrafluoroethylene and perfluoroalkyl vinyl ether (PFA). , Polychlorotrifluoroethylene (PCTFE), polyvinylidene fluoride (PVDF), ethylene-tetrafluoroethylene copolymer (ETFE), ethylene-chlorotrifluoroethylene copolymer (ECTFE), polypropylene (PP), etc. Can be mentioned.

The cover member 8 is formed integrally with the cylindrical main body 81 and the main body 81 so as to cover almost the entire circumference of the body 3 of the container main body 2, and closes the base end opening of the main body 81. And a bottom 83. In addition, the lid portion 82 is detachably attached to the distal end portion of the main body portion 81 and covers the mouth portion 7 of the container main body 2.

The main body 81 is made of a cylindrical member. The inner dimension of the main body 81 is set to a size that allows the body 3 of the container main body 2 to be inserted into the main body 81 without resistance. In a state where the container main body 2 is housed in the main body 81, the outer surface of the second wall 32b of the trunk 3 is close to (or abuts on) the inner surface of the main body 81, and the outer surface of the first wall 32a. A deformation space 810 for deforming the easily deformable portion 33 is formed between the main body portion 81 and the inner surface of the main body portion 81.

As shown in FIG. 5, the easily deformable portion 33 deformed so as to be reversed toward the outside of the container main body 2 in the solution filling state protrudes into the deformation space 810.

A “D” -shaped plate piece 811 is formed on the front end edge of the main body 81 so as to protrude toward the central axis. In a state where the container main body 2 is housed in the main body portion 81, the plate piece 811 is in close contact with the shoulder portion 34 of the trunk portion 3 and seals the distal end side of the deformation space 810. At this time, the plate piece 811 and the shoulder portion 34 of the trunk portion 3 constitute a substantially continuous smooth surface (see FIG. 1). When the main body 81 is manufactured, the main body 81 can be manufactured by configuring the plate piece 811 as a separate body and then welding the separate body to the distal end edge.

Further, a stepped portion 812 whose outer diameter changes stepwise is formed along the circumferential direction at the distal end portion of the main body portion 81. In a state where the lid portion 82 is attached to the main body portion 81, the base end of the lid portion 82 contacts the stepped portion 812. Thereby, positioning with respect to the main-body part 81 of the cover part 82 is made.

The lid portion 82 is composed of a bottomed cylindrical member. The inner diameter of the lid portion 82 is reduced in multiple stages in the axial direction (vertical direction) so that the inner shape of the lid portion 82 corresponds to the outer shape of the mouth portion 7 of the container body 2.

Such a cover member 8 (particularly, the main body portion 81) has a higher hardness than the easily deformable portion 33 of the container main body 2, that is, is set to be hard. Thereby, in the medicine storage container 1, since the easily deformable portion 33 is not directly exposed to the outside, it is possible to prevent an external force from being applied unintentionally to the easily deformable portion 33. For this reason, while preventing the easily deformable portion 33 having a relatively low strength from being damaged, the storage space 31 of the container body 2 is easily filled with the solution R to reliably dissolve the drug Q, and the drug P It can be reliably prepared.

Further, if the medicine Q is a medicine that is dangerous if a medical worker touches it by mistake, even if the medicine Q adheres to the outer surface of the container body 2 during the manufacture of the medicine storage container 1, for example, Since the container main body 2 is covered with the member 8, surrounding contamination can be prevented and the safety of medical personnel can be ensured.

A sheet material 9 is attached to the base end of the cover member 8. This sheet material 9 is removed from the cover member 8 before the storage space 31 is filled with the solution R. By removing the sheet material 9 from the cover member 8, the deformation space 810 formed between the container main body 2 and the cover member 8 (main body portion 81) can be opened through the communication hole 831.

Thereby, the inflow of air into the deformation space 810 and the outflow of air from the deformation space 810 are not hindered, and the solution R is injected into the storage space 31 of the container body 2 or from the storage space 31. When the chemical solution P is discharged, the easily deformable portion 33 can be easily and reliably reversed (see FIGS. 3 to 5).

Also, an edge portion 91 protruding outward is formed at the edge of the sheet material 9. The sheet material 9 can be easily removed from the cover member 8 by gripping the ears 91 with a finger or the like.

The cover member 8 and the sheet material 9 preferably have gas barrier properties and water vapor barrier properties. Thereby, it is possible to prevent oxygen and water vapor from entering the storage space 31 when the drug storage container 1 is stored, and to prevent the drug Q from being altered or deteriorated. Further, when the cover member 8 has a gas barrier property, in order to ensure the gas barrier property of the cover member 8, in a state where the cover portion 82 is attached to the main body portion 81, the cover member 8 is interposed between the cover portion 82 and the main body portion 81. Is preferably sealed with a material having gas barrier properties so as to cover the entire circumference from the outside.

Examples of the constituent material of the cover member 8 and the sheet material 9 include, for example, cyclic polyolefin, polyolefin, polyester, and the like. Further, the sheet material 9 can be formed of a metal such as polyamide or aluminum or a vapor deposition film of silica.

Further, in this case, it is possible to omit providing the gas barrier property to the container body 2 itself (in particular, the easily deformable portion 33), so that the easily deformable portion 33 can be formed thinner.

The drug storage container 1 as described above preferably has transparency from the viewpoint of ensuring internal visibility, but is configured to have a light-shielding property according to the type of drug Q to be stored. You can also.

Next, an example of a method for using the medicine container 1 will be described.
[1] First, the drug container 1 in the initial state shown in FIGS. 1 and 4 and a syringe filled with the solution R are prepared. This syringe is filled with a solution R having a sufficient amount to dissolve the drug Q in the drug container 1.

[2] Next, the ear portion 91 of the sheet material 9 is grasped with a finger or the like and removed from the main body portion 81 of the cover member 8, and the lid portion 82 is removed from the main body portion 81.

[3] Thereafter, the mouth 7 of the container body 2 and the syringe are connected. At this time, as described above, the valve body 5 of the mouth portion 7 is pressed toward the proximal direction, and the slit 512 of the valve body 5 is opened. Thereby, the inside of the container main body 2 and the inside of a syringe communicate.

[4] Next, the syringe pusher is pressed. Thereby, the solution R in the syringe is injected into the container body 2 through the mouth portion 7 of the container body 2, and the container body 2 is filled with the solution (see FIGS. 3 and 5).

At this time, the injected dissolving solution R gradually fills the storage space 31 and presses the easily deformable portion 33 outward. Thereby, the easily deformable part 33 begins to deform, and the volume of the storage space 31 increases. And when the melt | dissolution solution R more than predetermined amount fills the storage space 31, the easily deformable part 33 will be reversed outside. Therefore, in the medicine container 1, a pumping operation for adjusting the pressure in the container body 2 when the medicine is dissolved is not necessary. Moreover, it can prevent that the chemical | medical solution P spouts by the pressure rise in the container main body 2 at the time of chemical | medical agent melt | dissolution.

Further, even if the solution R is filled, the volume of the storage space 31 of the container body 2 increases, so that an increase in the pressure of the storage space 31 can be suppressed, and thus the reverse flow of the solution R to the syringe is prevented. Can be prevented. Further, the filling amount of the dissolving liquid R can be set to be equal to or less than the maximum volume of the storage space 31 of the container body 2.

[5] Next, the entire medicine container 1 to which the syringe is connected is shaken. As a result, the drug Q is more reliably dissolved in the solution R, and thus the drug P is generated (prepared).

[6] Next, the syringe pusher is pulled. Thereby, the chemical | medical solution P in the chemical | medical agent storage container 1 can be attracted | sucked in a syringe. The suction amount of the chemical liquid P can be appropriately adjusted according to the pull amount of the pusher of the syringe. Note that when the suction operation is performed, the easily deformable portion 33 is deformed in the reverse direction, so that the pressure drop in the container body 2 is alleviated and the chemical liquid P is easily sucked accurately.

Then, the syringe from which the drug solution P has been aspirated can be removed from the drug container 1 and used, for example, for drug solution administration to a patient.

Second Embodiment
FIG. 6 is a longitudinal sectional view showing an initial state of the medicine container (second embodiment) of the present invention.

Hereinafter, the second embodiment of the medicine container according to the present invention will be described with reference to this figure. However, the difference from the above-described embodiment will be mainly described, and description of similar matters will be omitted.

This embodiment is the same as the first embodiment except that the location of the easily deformable portion is mainly different.

In the medicine storage container 1 shown in FIG. 6, an easily deformable portion 33 is installed so as to cover the distal end opening of the cylindrical body 3 (hardly deformable portion 32) of the container body 2. The easily deformable portion 33 is configured by a ring-shaped member, and an outer edge portion thereof becomes a joint portion 330.

Further, the tubular channel member 10 is inserted through the central opening 333 of the easily deformable portion 33. The flow path member 10 communicates with the mouth portion 7 and is a member through which the solution R that has passed through the valve body 5 can flow down. A flange portion 101 whose outer diameter is enlarged is formed on the outer peripheral portion of the flow path member 10 so as to protrude. The flange 101 is joined to the edge of the central opening 333 of the easily deformable portion 33 by, for example, adhesion (adhesion with an adhesive or a solvent).

The flow path member 10 extends to the vicinity of the bottom 4 of the container body 2, and a deficient portion 102 is formed at the lower end thereof. Then, the solution R that has flowed down the flow path member 10 is supplied into the container body 2 through the defect 102. Thus, in the medicine container 1 of the present embodiment, the solution R is prevented from being supplied to the medicine Q so as to be sprayed from above. Thereby, it can prevent that foaming arises in the chemical | medical solution P obtained.

The main body 81 of the cover member 8 includes, for example, a first member 813 having a bottomed cylindrical shape, and an upper end portion of the first member 813, for example, fusion (thermal fusion, high frequency fusion, ultrasonic fusion, etc.) ) And the second member 814 joined together. This joining is performed over the entire circumference of the main body 81. Thereby, the airtightness in the main-body part 81 is ensured.

The upper end portion of the second member 814 has a reduced diameter, and the mouth portion 7 is inserted. In addition, a deformation space 810 is formed inside the second member 814.

The lid portion 82 is detachably attached to the upper end portion of the second member 814. When the lid 82 is mounted on the upper end of the second member 814, the gap between the lid 82 and the second member 814 is sealed with a member having gas barrier properties so as to cover the entire circumference from the outside. Has been. Thereby, the gas barrier property of the cover member 8 is ensured.

In the medicine container 1 of the present embodiment, the gap between the second member 814 and the mouth lid 73 functions as a communication hole, and the deformation space 810 is opened by removing the lid 82. Therefore, it is possible to omit the sheet material 9 that the medicine container 1 of the first embodiment has.

<Third Embodiment>
FIG. 7 is a longitudinal sectional view showing an initial state of the medicine container (third embodiment) according to the present invention, FIG. 8 is a longitudinal sectional view showing a solution filling state in the medicine container shown in FIG. FIG. 10 is a perspective view showing an easily deformable portion detachment preventing member provided in the medicine container shown in FIG. 7, and FIGS. 10 to 12 are diagrams for sequentially explaining the assembly process of the medicine container shown in FIG. .

Hereinafter, the third embodiment of the medicine container according to the present invention will be described with reference to these drawings. However, the difference from the above-described embodiment will be mainly described, and the description of the same matters will be omitted.
The present embodiment is the same as the first embodiment except that the medicine container further includes an easily deformable portion detachment preventing member and the like.

As shown in FIGS. 7 and 8, the medicine storage container 1 of the present embodiment further includes an easily deformable part detachment preventing member 12 and a container body detachment preventing member 13.
The easily deformable portion detachment preventing member 12 is housed in the cover member 8 together with the container body 2 and can fill the deformation space 810. As shown in FIG. 9, the easily deformable portion detachment portion preventing member 12 is configured by a semi-cylindrical member as a whole, and a flat portion 121 facing the container body 2 and the opposite side of the flat portion 121, that is, a cover member 8 and a curved portion 122 facing the inner peripheral portion. The easily deformable portion detachment preventing member 12 may be appropriately provided with a concave portion in the curved portion 122 for preventing sink marks in molding.

The flat part 121 can press the joint part 330 of the easily deformable part 33. And when the easily deformable part 33 of the container main body 2 (body part 3) expands in the solution filling state, the joint part 330 of the easily deformable part 33 is pulled in the peeling direction. The peeling is reliably prevented. Thereby, it can prevent reliably that the easily deformable part 33 detach | leaves from the difficultly deformable part 32. FIG.

In the flat portion 121, a concave portion 123 is formed at a portion where the easily deformable portion 33 faces. The concave portion 123 is a deformation space for the easily deformable portion 33 to be deformed, and has substantially the same shape as the shape of the easily deformable portion 33 that has expanded in the state of being filled with a solution. The easily deformable portion 33 that has expanded in a state where the solution is filled can enter the recess portion 123 (see FIG. 8). Thereby, excessive expansion | swelling of the easily deformable part 33 is prevented, Therefore, damage to the easily deformable part 33 can be prevented reliably. Moreover, it can prevent reliably that the force which exceeds a peeling limit is added to the junction part 330. FIG.

Further, the easily deformable portion detachment preventing member 12 and the container main body 2 can be engaged with each other so that the protruding portion 35 formed on one member (the container main body 2 in the present embodiment) and the other An engaging groove 124 formed in the member (in the present embodiment, the easily deformable portion detachment portion preventing member 12) is disposed. The protrusion 35 is disposed on the first wall portion 32 a of the container body 2. The engagement groove 124 is disposed in the flat portion 121 of the easily deformable portion detachment portion preventing member 12.

When the container main body 2 is housed in the main body 81 having the bottomed cylindrical shape and the opening 815 at the front end of the cover member 8 together with the easily deformable portion detachment preventing member 12, the container main body detachment preventing member 13 is stored. In addition, the easily deformable part detachment preventing member 12 is a member that prevents the cover member 8 from detaching from the main body 81. As shown in FIG. 12, the container main body detachment preventing member 13 is formed of a ring-shaped member, and the fixing portion 131 that is the outer peripheral portion thereof can be fitted into the opening 815 of the cover member 8. Thereby, the container main body detachment preventing member 13 is securely fixed to the cover member 8. In addition, as a fixing method of the fixing | fixed part 131, not only fitting but fusion | bonding, adhesion | attachment with an adhesive agent, etc. may be sufficient.

Also, the base end surface of the container main body detachment preventing member 13 functions as an engaging portion 134 that engages with the container main body 2 and the easily deformable portion detachment preventing member 12 housed in the cover member 8 from the distal end side. Thereby, when the container main body 2 is turned upside down together with the cover member 8 in order to suck the drug solution P in the container main body 2 into the syringe, the container main body 2 and the easily deformable part detachment preventing member 12 are not covered by the cover member 8. It is prevented from leaving. Therefore, the cover member 8 can be grasped and the chemical solution P can be sucked into the syringe. In the present embodiment, the container body 2 and the easily deformable portion detachment portion preventing member 12 are sandwiched between the engaging portion 134 and the bottom portion 83 of the cover member 8. Thereby, the container main body 2 and the easily deformable portion detachment preventing member 12 are prevented or regulated from being rattled while being accommodated in the cover member 8, and it is ensured that the medicine Q is broken by vibration or contact during transportation. Can be prevented.

Further, a projecting piece 132 is formed to project from the inner periphery of the container main body detachment preventing member 13. The container main body detachment preventing member 13 can be fitted to the cover member 8 by the projecting piece 132, and by this fitting, rotation of the container main body 2 with respect to the cover member 8 can be prevented.

Further, a groove 133 is formed in the abutting portion 135 of the projecting piece 132 of the container main body detachment preventing member 13 that abuts on the first wall portion 32a, and the flat portion 121 of the easily deformable portion detachment preventing member 12 is formed. In addition, a groove 125 is formed (see FIGS. 9, 10, and 12). The groove 133 and the groove 125 communicate with each other. Thereby, the recessed part 231 (deformation space) and external space will be connected. That is, the groove 133 and the groove 125 function as a communication portion that connects the recess 231 (deformation space) and the external space.

Further, as shown in FIG. 12, the projecting piece 132 can fill almost the entire gap between the first wall portion 32a and the main body portion 81 of the cover member 8. Thereby, it can prevent that a user touches the chemical | medical agent Q adhering to the 1st wall part 32a accidentally while using the chemical | medical agent storage container 1. FIG. In addition, when the easily deformable portion detachment preventing member 12 is omitted, the user may accidentally put a finger into the recess 123 (deformed space) and damage the easily deformable portion 33 during use of the medicine container 1. Can be prevented.

As shown in FIG. 11, when the container main body 2 and the easily deformable portion detachment preventing member 12 are stored in the cover member 8, the storage is performed using the storing jig 14. The storage jig 14 has a jig body 141 in which a through hole 142 is formed. A tapered portion 143 whose inner diameter gradually increases upward is formed at the upper portion of the inner peripheral portion that defines the through hole 142. When the storage jig 14 is used, first, the container body 2 and the easily deformable portion detachment preventing member 12 that are engaged with each other are disposed above the tapered portion 143, so The cover member 8 is disposed below. Next, when the container main body 2 and the easily deformable part detachment part preventing member 12 are moved downward, these engaging members are collectively guided toward the cover member 8 by the taper part 143. Thereby, the container main body 2 and the easily deformable part detachment part preventing member 12 can be easily and reliably inserted into the cover member 8. Such insertion is preferable because it can prevent an operator from accidentally touching the medicine Q when the medicine Q is attached to the container body 2.

In addition, the taper part which has the same taper angle as the taper part 143 may be provided also in the lower part of the container main body 2, and the easily deformable part detachment part prevention member 12, for example. Thereby, when inserting the container main body 2 and the easily deformable portion detachment preventing member 12 into the cover member 8, the insertion is guided by the taper portion, so that the container main body 2 and the easily deformable portion detaching portion preventing member 12 can be easily and reliably. It can be inserted into the cover member 8.

Next, an assembly process until the container body 2 and the easily deformable portion detachment preventing member 12 are housed in the cover member 8 and assembled will be described with reference to FIGS.
First, the protrusion 35 of the container body 2 is engaged with the engagement groove 124 of the easily deformable portion detachment preventing member 12, and as shown in FIG. Assemble.

Next, as shown in FIG. 11, the assembled container body 2 and the easily deformable portion detachment portion preventing member 12 are disposed above the taper portion 143 of the storage jig 14, and the cover member 8 is tapered. Arranged below the portion 143. Then, as described above, the container body 2 and the easily deformable portion detachment preventing member 12 are collectively stored in the cover member 8.

Next, as shown in FIG. 12, the container body detachment preventing member 13 is attached to the cover member 8 from above. As a result, an assembly in which the container body 2 and the easily deformable portion detachment preventing member 12 are prevented from detaching from the cover member 8 is obtained. The lid portion 82 can be attached to the assembly.

As mentioned above, although illustrated embodiment of the chemical | medical agent storage container of this invention was described, this invention is not limited to this, Each part which comprises a chemical | medical agent storage container is arbitrary structures which can exhibit the same function. Can be substituted. Moreover, arbitrary components may be added.

In the above embodiment, the cover member is configured to cover the entire body except the bottom of the container body. However, the cover member may be omitted and only the body part may be provided, and only the easily deformable part of the container body may be covered. It may be a simple configuration. In this case, in order to ensure the gas barrier property of the cover member, it is preferable to join the container body and the cover member by fusion or the like.

The communication hole may be provided as a small hole opened in the plate piece or a small gap opened between the plate piece and the shoulder. In this case, since the deformation space is opened through the communication hole by removing the lid from the main body, no sheet material is required.

Further, the number of the easily deformable portions is one in the above embodiment, but is not limited thereto, and may be a plurality of locations, for example.

In the initial state, the container body may be prefilled with an inert gas such as nitrogen. Thereby, although depending on the kind of chemical | medical agent, it can prevent more reliably that the said chemical | medical agent oxidizes.

In addition, the medicine to be stored is in a powder form in each of the above embodiments, but is not limited thereto, and may be in a tablet form, a gel form, or a liquid form, for example.

Further, in the above-described embodiment, the valve body is attached to the mouth portion of the medicine container. However, the present invention is not limited thereto, and a rubber stopper used in a conventional vial may be attached.

A drug storage container according to the present invention is a container main body provided with a mouth portion provided at a distal end portion to allow liquid to enter and exit, and a trunk portion provided at a proximal end side of the mouth portion and having a storage space for storing a medicine. The body portion is connected to the bottom portion provided on the opposite side of the mouth portion, the bottom portion and the mouth portion, and the storage space is filled with the liquid via the mouth portion. The deformable portion that does not deform or is difficult to deform, and the easily deformable portion that increases the volume of the storage space by being deformed, covers at least the easily deformable portion, and the easily deformable portion includes A cover member is provided outside the container main body so as to form a deformation space for deformation, and is harder than the easily deformable portion.

Therefore, the pressure rise inside the container can be alleviated by the easily deformable portion when the drug is dissolved, so that a complicated pumping operation can be easily performed. Thereby, the medicine storage container has excellent operability.

In addition, since the container body is configured to cover the container body with the cover member, even when the medicine adheres to the outer surface of the container body when the medicine is filled, the surrounding contamination by the medicine can be prevented.

Therefore, the medicine container of the present invention has industrial applicability.

Claims

A mouth part provided at the tip part and allowing liquid to enter and exit;
A container body provided on the proximal end side of the mouth, and including a trunk having a storage space for storing a medicine;
The trunk portion connects a bottom portion provided on the opposite side of the mouth portion, the bottom portion and the mouth portion, and does not deform when the storage space is filled with the liquid via the mouth portion. Or a hard-to-deform part that is difficult to deform and an easy-to-deform part to increase the volume of the storage space by being deformed,
A cover member is provided outside the container main body so as to cover at least the easily deformable portion and to form a deformation space for the deformable portion to be deformed, and is harder than the easily deformable portion. A medicine container.
The drug storage container according to claim 1, wherein the hardly deformable portion and the easily deformable portion are formed of different members and are joined to each other.
The drug container according to claim 2, wherein at least a surface of the container body facing the storage space is made of a low-adsorbing material with little drug adsorption.
4. The medicine container according to claim 3, wherein the low adsorptive material is mainly composed of cyclic polyolefin.
The hardly deformable portion is almost entirely composed of the low adsorptive material,
The easily deformable portion is provided facing the storage space, and is provided with an inner layer made of the low adsorptive material, and an outer layer that is provided on the opposite side of the inner layer from the storage space and reinforces the inner layer. The medicine container according to claim 4, comprising:
The cover member is provided with an opening at the front end and a bottom at the base end, a cylindrical main body that covers substantially the entire body, a detachable attachment to the main body, and the mouth The medicine storage container according to claim 2, further comprising a covering lid.
The medicine storage container according to claim 6, further comprising a container main body detachment preventing member that prevents the container main body from being detached from the main body portion of the cover member when the container main body is stored in the main body portion of the cover member.
The medicine container according to claim 7, wherein the container main body detachment preventing member has a fixing portion fixed to the opening of the cover member and an engaging portion that engages with the container main body from the front end side.
The body part of the cover member has a bottomed cylindrical shape,
The said container main body removal prevention member has a rotation prevention part which prevents rotation with respect to the main-body part of the said cover member of the said container main body when the said container main body is accommodated in the main-body part of the said cover member. Drug storage container.
The hard-to-deform portion is formed with a large opening, and a first wall portion to which the easy-deformable portion is joined so as to seal the large opening, and the axial direction of the cover member of the first wall portion A second wall portion that is curved along the inner peripheral surface of the cover member.
The container main body detachment preventing member has a ring shape, and has a projecting piece that protrudes on an inner peripheral portion thereof and is provided with an abutting portion that abuts on the first wall portion,
The medicine storage container according to claim 9, wherein the rotation prevention unit is configured by the protruding piece.
The medicine storage container according to claim 2, further comprising an easily deformable portion detachment preventing member that prevents the easily deformable portion from being detached from the hardly deformable portion.