JP4118305B2 - Multi-chamber container - Google Patents

Description

  The present invention relates to a multi-chamber container capable of, for example, preparing or blending a drug for infusion.

  Prior to the infusion of the patient, the infusion solution in the infusion bag or bottle may be prepared by mixing and dissolving a solid or liquid medicine such as a vitamin or antibiotic, for example. Has been done.

  In order to prepare such a drug solution, first, the puncture needle of the syringe is inserted into an elastic stopper such as an infusion bag, and the plunger is pulled to collect an appropriate amount of the infusate into the syringe. Next, the collected infusion is transferred to a container containing a pre-weighed medicine, and the medicine and the infusion are mixed and dissolved to obtain a medicine mixture. The drug mixture is aspirated and collected with the syringe, and the puncture needle of the syringe is pierced through an elastic stopper such as the previous infusion bag, and the plunger is pushed to return the drug mixture into the infusion bag.

  However, the preparation of such a chemical solution has the disadvantage that the operation procedure is complicated, and is particularly inconvenient when rapid infusion is required.

  In addition, the preparation of the chemical solution as described above has a problem that the liquid solution may be contaminated by bacteria and foreign matter may be mixed because a part of the infusion is once taken out and mixed and dissolved in another container.

  In order to solve such problems, the container and the solution (infusion solution) can be mixed aseptically and separated into two by heat-sealing the inner space of the container consisting of a soft bag with a sealing part. In addition, a container for storing a drug and a solution in each space is known (for example, see Patent Document 1). When it is necessary to prepare a chemical solution, the outside of the container is pressed to break the seal portion, and the drug and the solution are mixed.

  Since the entire container is composed of a flexible sheet material, when a pressure is applied from the outside of the container, a hard solid drug and the sheet material may rub against each other to generate a pinhole. When pinholes are generated in this way, gas, for example, moisture in the air, oxygen, carbon dioxide, or the like may enter from the pinholes and alter the chemicals in the container.

  Alternatively, the seal part can be easily broken by external pressure or impact, and the dissolved solution leaks and mixes the drug with the dissolved solution except when necessary, so that the stability and safety of the drug can be maintained. It can be difficult.

  Furthermore, since a flexible sheet material generally has a relatively high gas permeability, there is a case where the chemical comes into contact with moisture, oxygen, etc. due to gas intrusion into the container and decomposes or deteriorates. Therefore, a portion of the container in which the medicine is accommodated is double-wrapped with a gas-impermeable packaging material, and an oxygen scavenger and a desiccant are enclosed inside the packaging material.

  However, packaging with a packaging material or encapsulating an oxygen scavenger or the like in this way makes the manufacturing process complicated and makes the container bulky, which is disadvantageous for transportation and storage.

Japanese Unexamined Patent Publication No. 4-364851

  It is an object of the present invention to mix a drug and a liquid such as an infusion by a simple operation when necessary. Particularly, the transfer of the drug can be performed smoothly and quickly, and bubbles remain in the drug container. It is in providing the multi-chamber container which can prevent. It is another object of the present invention to provide a multi-chamber container that has a high liquid tightness and is free from accidents such as accidental mixing of the liquids, and that can prevent alteration and decomposition of the drug in the container with a simple configuration.

Such an object is achieved by the present inventions (1) to (18) below.
(1) A multi-chamber container comprising a bag made of a soft material having a first space for storing a liquid therein, and a drug container having a second space for storing a drug therein.
The drug container includes a container main body, a partition wall located at an end of the container main body on the bag side, and separating the first space and the second space, and a break portion formed around the partition wall And a breaking operation member that performs a breaking operation of the breaking portion,
The rupture portion and the rupture operation member constitute a communication mechanism that enables communication between the first space and the second space when necessary.
The breaking operation member is formed of a cylindrical body, and a liquid passing portion capable of discharging the liquid is formed on the wall portion thereof.
The multi-chamber container, wherein the medicine container is fixed to the bag so that the breaking operation member protrudes to the inside of the bag.

  (2) When the liquid in the first space flows into the second space by the communication by the communication mechanism, the drug container has the first space for the medicine stored in the second space. The multi-chamber container according to the above (1), which has a shape that can smoothly move to and prevent bubbles from remaining in the second space.

  (3) In the drug container, the inner surface of the container main body forming the second space is configured by a surface having substantially no step after communication by the communication mechanism (1) or (2) A multi-chamber container described in 1.

  (4) The multi-chamber container according to any one of (1) to (3), wherein an inner surface of the drug container has a cylindrical shape or a truncated cone shape.

  (5) The multi-chamber container according to any one of (1) to (4), wherein the breaking operation member is configured so that liquid is not held therein after the breaking portion is broken.

(6) The multi-chamber container according to (5) , wherein the liquid passing portion is a slit formed in a side portion of the cylindrical body.

(7) The multi-chamber container according to any one of (1) to (6) , wherein the fracture portion is configured by a thin fragile portion.

(8) The multi-chamber container according to (7) , wherein the thin fragile portion is provided by forming a V-shaped groove.

(9) The multi-chamber container according to (7) or (8) , wherein the minimum thickness of the thin-walled fragile portion is 0.05 to 0.35 mm.

(10) The multi-chamber container according to any one of (1) to (9) , wherein the communication mechanism can perform a communication operation from the outside of the bag.

(11) The multi-chamber container according to any one of (1) to (10) , wherein at least a portion that defines the second space is made of a hard material.

(12) The multi-chamber container according to any one of (1) to (11) , wherein the container body, the partition wall, and the fracture portion are integrally formed of a hard material.

(13) The multi-chamber container according to any one of (1) to (12) , wherein the medicine container is fixed to the bag via an outer cylinder.

(14) The drug container according to the above (1) to (12) , wherein the drug container is fixed by being sandwiched, fused and fixed between resin sheet materials constituting the bag at one end of the bag. The multi-chamber container according to any one of the above.

(15) The multi-chamber container according to (13) or (14) , wherein the outer cylinder is made of a material similar to a resin material of a sheet material constituting the bag.

(16) The multi-chamber container according to any one of (1) to (15) , wherein a liquid discharge port is provided at an end of the drug container opposite to the communication mechanism.

(17) The multi-chamber container according to (16) , wherein the discharge port includes an elastic body that can pierce a needle tube.

(18) The multi-chamber container according to any one of (1) to (17) , wherein the second space is in a reduced pressure or vacuum state.

  According to the multi-chamber container of the present invention, the space for storing each of the infusion and the like is not communicated except when necessary, and the stability and safety of the chemical is high.

  In addition, since there is no possibility that pinholes are formed in the drug container, gas and moisture do not enter the container, and alteration, decomposition, deterioration, etc. of the drug can be prevented. And since the packaging material etc. which enclosed the oxygen absorber and the desiccant are unnecessary like the past, the whole container can be reduced in size and conveyance, storage, etc. become easy.

  Then, the communication operation between the first space and the second space by the communication mechanism, particularly the breaking operation of the breaking portion can be easily and reliably performed.

In addition, the medicine in the second space can be smoothly and quickly transferred to the first space, and the bubbles can be prevented from remaining in the second space. Adverse effects can be eliminated, and in particular, the infusion can be stably supplied.
And the residual amount of the infusion agent in a bag can be decreased, and there is no waste of an infusion agent.

  Furthermore, by operating the communication mechanism from the outside of the multi-chamber container, the infusion agent and the drug can be mixed and dissolved, so that the drug solution can be quickly prepared. In addition, since the infusion agent and the like do not come into contact with the outside air during preparation, there is no possibility of contamination with bacteria and foreign substances, and the preparation of the chemical solution can be performed safely.

Further, when the drug container is sandwiched and fused between the sheet materials (especially through the outer cylinder) at one end of the bag, the drug container can be easily and reliably fixed to the bag. In addition, since the bonding property and adhesion (sealing property) between the two are high, liquid leakage and the like can be reliably prevented.
Moreover, the multi-chamber container of the present invention is easy to manufacture and assemble.

Hereinafter, the multi-chamber container of the present invention will be described in detail based on preferred embodiments shown in the accompanying drawings.
1 and 2 are respectively a partial cross-sectional front view showing an embodiment of a multi-chamber container of the present invention, FIG. 3 is a cross-sectional view taken along the line AA in FIG. 1, and FIG. FIG. Among these, FIG. 1 shows a state where the communication mechanism of the multi-chamber container is not in communication, and FIG. 2 shows a state where the communication mechanism of the multi-chamber container is in communication. The upper side in FIGS. 1 and 2 will be described as “base end” and the lower side will be described as “tip”.

  As shown in FIGS. 1 and 2, the multi-chamber container 1 of the present invention contains a bag 2 made of a soft material having a first space 21 for containing a liquid such as an infusion solution 26 and the like, and contains a drug inside. And a medicine container 3 made of a hard material having a second space 33. The medicine container 3 includes a communication mechanism 4 that partitions the first space 21 and the second space 33 and can communicate the first space 21 and the second space 33 when necessary.

Hereinafter, each of these components will be sequentially described.
The bag 2 is formed by forming a sheet material made of a flexible soft material into a tube shape (tube shape), and sealing both ends thereof by fusion (thermal fusion, high frequency fusion, etc.) or bonding, and forming a bag shape. It is what. The proximal end side seal portion 22 and the distal end side seal portion 24 of the bag 2 are each cut into a desired shape.

  A first space 21 is formed inside the bag 2, and an infusion solution (liquid) 26 is accommodated therein.

  Examples of the infusion agent 26 include physiological saline, electrolyte solution, Ringer's solution, high-calorie infusion solution, glucose solution, water for injection, and the like, but are not limited thereto.

  Further, a hole (hanging portion) 23 for suspending the multi-chamber container 1 on a hanger or the like is provided in the seal portion 22 on the proximal end side of the bag 2.

  As the material constituting the bag 2 (the material of the sheet material 25), for example, a resin material capable of forming a soft (soft and flexible) sheet is preferable. Thereby, the operation of the communication mechanism 4 described later can be easily performed from the outside of the bag 2.

  Examples of such resin materials include polyethylene, polypropylene, polybutadiene, polyolefin such as ethylene-vinyl acetate copolymer (EVA), polyester such as polyethylene terephthalate (PET) and polybutylene terephthalate (PBT), and soft polychlorinated resin. Examples thereof include various thermoplastic elastomers such as vinyl, polyvinylidene chloride, silicone, polyurethane, polyamide elastomer, and polyester elastomer, or combinations thereof (blend resin, polymer alloy, laminate, etc.).

  Particularly preferable as the constituent material of the bag 2 is a soft resin obtained by blending an elastomer such as styrene-butadiene copolymer or styrene-ethylene-butylene-styrene block copolymer with polypropylene. This material is preferable in that it is excellent in water resistance, heat resistance, flexibility and processability, and can reduce the manufacturing cost.

  Furthermore, in order to maintain the quality of the infusion solution 26, it is possible to further laminate a film such as an aluminum foil in order to give the bag 2 an oxygen barrier property, a light shielding property, and the like.

  In order to provide oxygen barrier properties, a thin film such as a vapor deposition film made of an oxide such as titanium oxide, aluminum oxide, or silicon oxide can be formed on the surface of the bag 2. Even in this case, the transparency of the bag 2 can be maintained, and when the communication mechanism 4 performs the communication operation, it is easy to visually confirm the communication state, the mixing / dissolving state of the infusion solution 26 and the drug 34, and the like. Therefore, it is preferable.

  The thickness of the sheet material 25 constituting the bag 2 is not particularly limited and varies depending on the material of the sheet material 25. For example, a soft polyvinyl chloride sheet material or the above-mentioned polypropylene is blended with a styrene-butadiene copolymer. In the case of a softened soft resin, it is preferably about 20 to 500 μm.

  A drug container 3 is fixed to the front end of the bag 2. The drug container 3 includes a cylindrical (particularly cylindrical) container main body 31, an outer cylinder 32 installed outside the container main body 31, and a communication mechanism 4 provided on the proximal end side of the container main body 31. Yes. The opening of the container body 31 is hermetically sealed with an elastic body (plug body) 51 described later. A space surrounded by the container main body 31, the communication mechanism 4, and the elastic body 51 is a second space 33.

  An appropriate amount of medicine 34 is accommodated in the second space 33. The form of the drug 34 may be any form such as solid (including powder and granules), liquid, and the like, but in this example, a solid drug will be described as a representative.

  This drug 34 is formulated and dissolved in the infusion solution 26. For example, antibiotics, vitamins (general vitamins), various amino acids, antithrombotic agents such as heparin, insulin, antitumor agents, analgesics, Examples include cardiotonic agents, intravenous anesthetics, anti-parkinsonian agents, ulcer treatment agents, corticosteroid agents, arrhythmic agents, correction electrolytes, antiviral agents, immunostimulants, and anticancer agents.

In addition, the second space 33 may be normal pressure, but may be reduced pressure or vacuum.
Thus, when the second space 33 is in a reduced pressure or vacuum state, the effect of preventing the agent 34 from being altered, decomposed or deteriorated is improved, and the infusate 26 is sucked when the fractured portion 41 is broken. In addition, it can be introduced into the second space 33 more quickly.

  The container body 31 has a volume sufficient to accommodate the drug 34 and to introduce the infusion solution 26 and dissolve and mix it. A partition wall 44 is formed on the proximal end side of the container body 31, and a fracture portion 41 is formed on the outer periphery of the partition wall 44.

  The inner side surface (inner peripheral surface) 311 of the container body 31 after being communicated by the communication mechanism 4 described later (after the fractured portion 41 is fractured) is configured by a surface (flat surface) having substantially no step. In particular, the inner surface 311 has a cylindrical shape or a truncated cone shape. In this embodiment, the inner side surface 311 is constituted by a truncated cone-shaped surface whose inner diameter is slightly reduced toward the proximal direction.

  Since the inner side surface 311 is formed of a surface having substantially no steps, the following effects are produced. When the first space 21 and the second space 33 communicate with each other by the communication mechanism 4, the medicine 34 in the container main body 31 can be smoothly and quickly transferred to the first space 21. In addition, when the first space 21 and the second space 33 are communicated with each other by the communication mechanism 4 and the infusion agent 26 flows into the second space 33, bubbles are generated in the first space 21. Even in this case, the bubbles are smoothly discharged toward the first space 21 and are prevented from remaining in the second space 33.

  In addition, such an effect of preventing air bubbles from remaining is also exhibited when infusion is performed on a patient. That is, when the needle tube of an infusion set (not shown) is pierced through the elastic body 51, the tip of the medicine container 3 is directed downward, and the infusion agent 26 is discharged from the bag 2 by the action of gravity and administered to the patient. Even when air in the infusion set (especially in the drip tube) rises as bubbles and enters the container body 31, the bubbles move into the bag 2 without staying in the container body 31, and the base end thereof Go up to the side. If bubbles remain in the container main body 31, there is a risk of adverse effects such as poor fluid circulation and instability of the supply rate of the infusion solution 26. Since no residue is produced, good liquid flowability is ensured, and the above-described adverse effects are prevented.

  In addition, the fact that no bubbles remain in the container body 31 is advantageous in terms of appearance. That is, for example, when the drug 34 is a yellow vitamin agent, the infusate 26 after the drug is dissolved and mixed is colored, so such bubbles in the infusion agent 26 are particularly noticeable and unnatural in appearance. However, according to the present invention, since bubbles remain in the container main body 31 as described above, such a problem does not occur. .

  In consideration of such residual effect of bubbles, the “substantially step-free surface” is a smooth surface having no step, or even if there are some steps, the bubble is caught. This means that it is not a large step or steep step that prevents the rising. Further, the “step” in the “surface having substantially no step” means a step in the direction involved in the movement of bubbles, that is, the longitudinal direction of the container body 31 (vertical direction in FIG. 1).

  The communication mechanism 4 protrudes inside the bag 2 (first space 21). The communication mechanism 4 includes a breaking portion 41 constituted by a thin and weak portion, and a lever (breaking operation member) 42 for performing a breaking operation of the breaking portion 41. The breaking portion 41 is formed along the outer periphery of the partition wall 44 and connects the proximal end of the container body 31 and the distal end of the lever 42 in a liquid-tight manner.

  As shown in FIG. 4, the partition wall 44 is disposed at a position near the lever 42 side of the fracture portion 41 in a posture substantially perpendicular to the inner side surface 311 (the base end portion thereof).

  Further, as shown in an enlarged view in FIG. 4, the fracture portion (thin fragile portion) 41 is provided by forming a V-shaped groove 43. The groove 43 is preferably formed continuously over substantially the entire circumference of the drug container 3, but may be formed intermittently (intermittently) along the circumferential direction of the drug container 3.

  The bottom of the V-shaped groove 43 may be a flat surface, but it is preferable that the bottom of the groove 43 is pointed in terms of ease of breaking operation and excellent certainty of breaking.

  In the present invention, the cross-sectional shape of the groove is not limited to a V shape, and may be any shape such as a U shape or a semicircular shape.

  The minimum thickness (thickness at the bottom of the groove 43) T of the rupture portion (thin fragile portion) 41 is not particularly limited, but is preferably about 0.05 to 0.35 mm, preferably 0.1 to 0.28 mm. More preferred is the degree. This is because if the thickness is too thick, the breaking operation of the breaking portion 41 is difficult, and if it is too thin, defects such as pinholes are likely to occur.

  The lever 42 is composed of a bottomed cylindrical member (tubular body). A partition wall 44 that shields the base end opening of the container main body 31, that is, blocks the first space 21 and the second space 33, is formed at the distal end (bottom) of the lever 42.

  The lever 42 has a structure in which the liquid (infusion agent 26) is not held in the lever 42 when the broken portion 45 is broken by the broken portion 41 (see FIG. 2). That is, at least one, preferably a plurality of slits 47 are formed in the side wall (wall portion) 46 of the cylindrical lever 42 as a liquid passing portion. When almost all of the infusate 26 is discharged from the bag 2, the infusate 26 that has entered the cylindrical body of the lever 42 is discharged through the slit 47. Therefore, the infusion agent 26 can be discharged from the bag 2 without waste.

  As another example of the configuration in which the liquid (infusion solution 26) is not held inside the lever 42 after breaking and separating, a configuration in which the internal space of the lever is a closed space and a configuration in which the lever is a solid member are available. Can be mentioned.

  When the lever 42 is gripped from above the sheet material of the bag 2 and moved (rotated) in the direction perpendicular to the paper surface of FIG. 1, the breaking portion 41 is broken to form an opening 48, and the first space 21 and The second space 33 communicates (see FIG. 2).

  It is preferable that the opening 48 formed by the fracture has an opening area that can sufficiently ensure the flow of the liquid between the first space 21 and the second space 33.

The opening area of the opening 48, is preferably from about ² 15～120Mm, it is more preferably ² about 20～85Mm. If this opening area is too small, the flowability of the liquid is reduced, and if it is too large, the breaking operation of the breaking portion 41 may be difficult.

  By setting the opening area of the opening 48 to a necessary and sufficient value in this manner, the breaking operation of the breaking portion 41 can be easily and reliably performed, and the infusion agent 26 in the first space 21 can be second. It is possible to quickly flow into the space 33 and to dissolve and mix the drug 34 quickly and efficiently.

  The shape of the opening 48 is not particularly limited, and may be, for example, an ellipse having a major axis in the width direction of the bag 2 or a rectangle in addition to the circular shape as in the present embodiment.

  Such a communication mechanism 4 is preferably capable of breaking the breaking portion 41 from the outside of the bag 2 by a communication operation of the communication mechanism 4, that is, a movement operation of the lever 42. Thereby, there is no need to open the multi-chamber container 1 or take out the infusion solution 26 for the preparation of the chemical solution, and there is no possibility of contamination of the chemical solution by bacteria or contamination with foreign substances.

  The container body 31 and the communication mechanism 4 of the drug container 3 are preferably formed integrally, but may be formed by joining different members. Moreover, when forming the container main body 31 and the communication mechanism 4 integrally, it is preferable that these are shape | molded by injection molding.

  The container body 31 and the communication mechanism 4 of the medicine container 3 are preferably made of a hard material, particularly a hard resin material.

  Due to the hard material, the drug container 3 is greatly deformed, and the drug 34 and the sheet material constituting the drug container 3 are in sliding contact with each other as in the prior art, so that a pinhole is formed in the sheet material. Will not occur. Therefore, gas (water vapor, oxygen, or the like) does not enter the second space 33 from the pinhole, and the chemical agent 34 can be prevented from being altered, decomposed, deteriorated, or the like.

  Further, by using a hard material, there is also an advantage that the breaking portion 41 can be easily and reliably broken by the operation of the lever 42.

  In addition, at least the container main body 31 of the drug container 3 is preferably made of a transparent or translucent material in order to ensure internal visibility.

  Examples of the hard material used for the drug container 3 include polyolefin such as hard polyvinyl chloride, polyethylene, polypropylene, and polybutadiene, cyclic polyolefin, polystyrene, poly- (4-methylpentene-1), polycarbonate, ABS resin, and acrylic resin. , Polymethyl methacrylate (PMMA), polyacetal, polyarylate, polyacrylonitrile, polysulfone, polyethersulfone, polyvinylidene fluoride, ionomer, acrylonitrile-butadiene-styrene copolymer, polyethylene terephthalate (PET), polybutylene terephthalate (PTB) Various resins such as polyesters such as polyethylene naphthalate (PEN), butadiene-styrene copolymers, aromatic or aliphatic polyamides, Copolymers containing these, polymer blends, poly - alloy, or a combination of any two or more of these (e.g., composites) can be mentioned.

  Among these, polypropylene, polycarbonate, cyclic polyolefin, and PEN are particularly preferable from the viewpoint of excellent heat resistance.

  Further, from the viewpoint of high safety and excellent adhesion to the bag 2 or the outer cylinder 32, hard polyvinyl chloride, polyethylene, polypropylene, polyester (particularly PEN) is preferable, and oxygen, carbon dioxide, water vapor, etc. Polyester (especially PEN), from the point that the gas permeability is low, the quality, quality, and quality of the drug 34 in the drug container 3 can be prevented, and the quality control can be performed more strictly. Polyacrylonitrile and polyvinylidene fluoride are preferred.

When a relatively gas-permeable resin material such as polypropylene or cyclic polyolefin is used as the hard material, a layer made of an oxide such as SiO ₂ , Al ₂ O ₃ , or TiO _{3 on the} surface ( By forming the gas barrier layer) by means such as vapor deposition or sputtering, the gas impermeability can be improved while maintaining transparency.

  Although not shown, a film that hermetically seals the distal end opening may be provided at the distal end of the container body 31. Examples of the membrane include a resin film made of polyethylene, polypropylene, polybutadiene, polyolefin such as ethylene-vinyl acetate copolymer (EVA), polyvinyl chloride, or the like.

  A discharge port 5 for discharging a chemical solution (liquid) is provided at the tip of the drug container 3 (the end opposite to the communication mechanism 4). The discharge port 5 has an elastic body (plug body) 51 made of an elastic material, and a cap (elastic body support member) 52 is crowned on the elastic body 51 to attach the elastic body 51 to the distal end of the drug container 3. It is the thing of the structure crimped | bonded.

As a result, the second space 33 is hermetically sealed by the elastic body 51 so that the chemical liquid does not leak to the outside, and gas such as O ₂ gas, CO ₂ gas, and water vapor, and microorganisms such as bacteria Does not penetrate inside.

  The elastic body 51 can pierce a needle tube (not shown), and the needle tube can be pierced when necessary to take out the chemical solution in the multi-chamber container 1. Further, the elastic body 51 has a self-occlusion property, and after the needle tube is extracted from the elastic body 51, the puncture hole is closed to prevent leakage of the drug solution.

  As a constituent material of the elastic body 51, a flexible polymer material is preferable. For example, polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, and cross-linked ethylene-vinyl acetate copolymer. Such as polyolefin, polyester, polyvinyl chloride, polyurethane, polyamide, polyamide elastomer, polyester elastomer, and other thermoplastic resins (thermoplastic elastomer), natural rubber, isoprene rubber, silicone rubber, butadiene rubber, styrene-butadiene rubber, etc. Examples thereof include elastic materials such as rubber materials, or combinations of any two or more of these (blends, laminates, etc.).

  The cap 52 has a ring shape and is fixed to the distal end portion of the outer cylinder 32 by a method such as screwing, fitting, caulking, adhesion, or fusion.

  The material of the cap 52 is not particularly limited, and examples thereof include various resin materials and metal materials.

  In the multi-chamber container 1, the container body 31 of the drug container 3 is inserted in close contact with the outer cylinder 32.

  As the constituent material of the outer cylinder 32, for example, the hard material mentioned as the constituent material of the container main body 31 or the resin material constituting the bag 2 can be used, but the latter is preferable. Thereby, at the time of manufacture of the multi-chamber container 1, the drug container 3 can be easily fixed (fused) to the bag 2, and the effect of increasing the bonding strength can be obtained.

  Such a drug container 3 is sandwiched and fused between the sheet materials 25 and 25 via the outer cylinder 32 at the seal portion 24 at the tip of the bag 2 (see FIGS. 1 and 3). . Thereby, the medicine container 3 can be fixed to the bag 2 easily and surely, and since the joining property and adhesion (sealing property) of both are high, liquid leakage and the like can be reliably prevented. Moreover, there exists an advantage that manufacture and an assembly of the multi-chamber container 1 are easy.

  In the present invention, a holding means (not shown) may be provided for holding the broken piece 45 generated by breaking the broken portion 41 of the communication mechanism 4 (regulating the movement of the broken piece 45). As such a holding means, for example, a deformable cover member that encapsulates the lever 42 and has liquid permeability in at least a part thereof can be cited. When such a holding means is provided, the broken piece 45 may float or float in the infusate 26 after the first space 21 and the second space 33 communicate with each other due to the breakage of the breakage portion 41. Is prevented.

  Next, an example of the manufacturing method (assembly method) of the multi-chamber container 1 of the present invention and the operation of the multi-chamber container 1 of the present invention will be described.

  First, the parts (including the bag 2, the medicine container 3, and the discharge port 5) constituting the multi-chamber container 1 having a predetermined size and capacity are manufactured.

  Initially, the bag 2 is not sealed at both ends. An appropriate amount of drug 34 is placed in a sterile state in the second space 33 of the drug container 3, and the discharge port 5 is attached to the tip of the drug container 3. That is, the tip opening of the container body 31 is hermetically sealed by the elastic body 51.

  The medicine container 3 containing the medicine 34 obtained as described above is inserted partway into the opening on the front end side of the bag 2 and sealed by fusion to form the seal portion 24. Thereby, the medicine container 3 is fused and fixed to the seal portion 24.

  Next, a predetermined amount of infusion agent 26 is injected into the bag 2 from the opening on the proximal end side of the bag 2, and then sealed by fusion to form the seal portion 22. In this way, the multi-chamber container 1 is completed.

  If necessary, the obtained multi-chamber container 1 is sterilized by autoclave sterilization or the like.

  Unlike the above, after the drug container 3 is fixed to the bag 2 and sterilized, the drug 34 is introduced into the drug container 3 and sealed with the elastic body 51 (attachment of the discharge port 5). Good.

  When performing the communication operation of the communication mechanism 4 of the multi-chamber container 1 obtained in this way, the lever 42 is grasped by hand from the outside of the bag 2 (if the cover member is provided, the cover member is grasped together). ), Rotate. Thereby, the fracture | rupture part 41 fractures | ruptures and the lever 42 (broken piece 45) isolate | separates from the container main body 31. FIG. Then, an opening 48 is formed at the proximal end of the container main body 31, and the first space 21 and the second space 33 communicate with each other. In order to surely break the breaking portion 41, the turning operation of the lever 42 is preferably made to reciprocate the lever 42 at least once.

  When the opening 48 is formed, the infusion agent 26 in the first space 21 quickly flows into the second space 33 through the opening 48. Thereby, the infusion agent 26 and the medicine 34 can be efficiently mixed and dissolved. At this time, the bag 2 may be pressed or shaken from the outside in order to promote the circulation, mixing and dissolution of the liquid.

  After the chemical | medical agent 34 is melt | dissolved completely, the multi-chamber container 1 is shaken and it stirs so that a chemical | medical solution may become uniform. Thereby, preparation of a chemical | medical solution is completed.

  In addition, since the inner side surface 311 of the container body 31 is configured with a surface having substantially no step, the medicine 34 is smoothly discharged and moves to the first space 21 side, and into the second space 33. Even if bubbles are generated, the bubbles quickly move (float) toward the first space 21, and no bubbles remain in the second space 33.

  When the preparation of the medicinal solution is completed in this manner, the infusion solution can be administered to the patient through the infusion set through the elastic stopper 51 and in accordance with a conventional method.

  At this time, even if air bubbles rise from the infusion set side, the air bubbles do not stay in the second space 33 and move (float) to the first space 21 side as described above. Thereby, the infusion agent 26 can be supplied at a stable speed (speed set on the infusion set side).

  When almost the entire amount of the infusate 26 is discharged from the bag 2, the lever 42 that has become the broken piece 45 remains in the first space 21, but has entered the inside of the cylindrical body of the lever 42. The infusion agent 26 is discharged through the slit 47. Therefore, the infusion agent 26 can be discharged from the bag 2 without waste.

  As mentioned above, although the multi-chamber container of this invention was demonstrated based on each Example of illustration, this invention is not limited to these. For example, the shape and structure of the communication mechanism are not limited to those constituted by a lever and a fracture portion as shown in the figure, and the communication method is not limited to that by fracture. Further, the cross-sectional shape of the second space is not necessarily limited to a circular shape.

It is a fragmentary sectional front view which shows the Example (at the time of a communication mechanism non-opening) of the multiple chamber container of this invention. It is a fragmentary sectional front view which shows the Example (at the time of communication mechanism opening) of the multiple chamber container of this invention. It is the sectional view on the AA line in FIG. It is an expanded sectional view near the fracture | rupture part of a chemical | medical agent container.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Multi-chamber container 2 Bag 21 1st space 22 Seal part 23 Hole 24 Seal part 25 Sheet material 26 Infusion agent 3 Drug container 31 Container main body 311 Inner side surface 32 Outer cylinder 33 2nd space 34 Drug 4 Communication mechanism 41 Breaking part 42 Lever 43 Groove 44 Bulkhead 45 Broken fragment 46 Side wall 47 Slit 48 Opening 5 Ejection port 51 Elastic body 52 Cap

Claims (18)

A multi-chamber container comprising a bag made of a soft material having a first space for containing a liquid therein, and a drug container having a second space for containing the drug inside;
The drug container includes a container main body, a partition wall located at an end of the container main body on the bag side, and separating the first space and the second space, and a break portion formed around the partition wall And a breaking operation member that performs a breaking operation of the breaking portion,
The rupture portion and the rupture operation member constitute a communication mechanism that enables communication between the first space and the second space when necessary.
The breaking operation member is formed of a cylindrical body, and a liquid passing portion capable of discharging the liquid is formed on the wall portion thereof.
The multi-chamber container, wherein the medicine container is fixed to the bag so that the breaking operation member protrudes to the inside of the bag.   When the liquid in the first space flows into the second space due to communication by the communication mechanism, the drug container moves to the first space of the drug stored in the second space. The multi-chamber container according to claim 1, wherein the multi-chamber container is shaped so as to be able to smoothly perform and prevent bubbles from remaining in the second space.   3. The multi-chamber container according to claim 1, wherein an inner side surface of the container main body forming the second space is configured by a surface substantially free of a step after communication by the communication mechanism. .   The multi-chamber container according to any one of claims 1 to 3, wherein an inner surface of the medicine container has a cylindrical shape or a truncated cone shape.   The multi-chamber container according to any one of claims 1 to 4, wherein the breaking operation member is configured so that liquid is not held therein after the breaking portion is broken. The multi-chamber container according to claim 5 , wherein the liquid passing part is a slit formed in a side part of the cylindrical body. The multi-chamber container according to any one of claims 1 to 6 , wherein the rupture portion is formed of a thin fragile portion. The multi-chamber container according to claim 7 , wherein the thin fragile portion is provided by forming a V-shaped groove. The multi-chamber container according to claim 7 or 8 , wherein the thin fragile portion has a minimum thickness of 0.05 to 0.35 mm. The multi-chamber container according to any one of claims 1 to 9 , wherein the communication mechanism can perform a communication operation from the outside of the bag. The medicament container, multi-chamber container according to at least one of claims 1 to 10 portion defining the second space is constituted by a rigid material. The multi-chamber container according to any one of claims 1 to 11 , wherein the container main body, the partition wall, and the fracture portion are integrally formed of a hard material. The multi-chamber container according to any one of claims 1 to 12 , wherein the medicine container is fixed to the bag via an outer cylinder. The compound medicine container according to any one of claims 1 to 12 , wherein the medicine container is fixed by being sandwiched, fused and fixed between resin sheet materials constituting the bag at one end of the bag. Chamber container. The multi-chamber container according to claim 13 or 14 , wherein the outer cylinder is made of a material similar to a resin material of a sheet material constituting the bag. The multi-chamber container according to any one of claims 1 to 15 , further comprising a liquid discharge port at an end of the medicine container opposite to the communication mechanism. The multi-chamber container according to claim 16 , wherein the discharge port includes an elastic body that can pierce a needle tube. The multi-chamber container according to any one of claims 1 to 17 , wherein the second space is in a reduced pressure or vacuum state.

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