Medical double-chambered container

JP2026144934APending Publication Date: 2026-09-09HOSOKAWA YOKO CO LTD
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Patent Information

Application Number
JP2025129349
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2025-02-28
Filing Date
2025-08-01
Publication Date
2026-09-09

AI Technical Summary

Benefits of technology

【0016】 本発明によれば、添加剤成分の溶出の懸念がなく、透明性に優れるうえ、使用時に薬剤室の両側部を両手でつかんで内側に押し込むように押圧した場合でも折れ曲がりシワができにくく、流入阻止用弱シール部が容易に剥離し、フィルムの破れを抑制できる医療用複室容器が提供される。

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Abstract

The present invention provides a medical multi-chamber container that eliminates concerns about the leaching of additive components, offers excellent transparency, resists creasing and folding even when both sides of the drug chamber are pressed inward, and has a weak seal for preventing inflow that peels off easily, thus suppressing film tearing. [Solution] A multi-chamber medical container comprising a container body having multiple drug chambers formed of a film mainly composed of polyethylene resin, and a port, wherein a weak seal portion for preventing inflow is formed in the drug chambers where the port is provided, and in a plan view, when the radius of curvature of the arc of the edge of the curved seal portion of the weak seal portion for preventing inflow on the side furthest from the port is r (mm), the central angle of the sector formed by the arc of the edge of the curved seal portion is θ (°), the height dimension of the weak seal portion for preventing inflow is A (mm), the width dimension is B (mm), and the width dimension of the container body is W (mm), the conditions satisfying 20 ≤ r ≤ 40, θ > 100°, B / W ≤ 0.26, and 0.40 ≤ A / B ≤ 0.50.
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Description

Technical Field

[0001] The present invention relates to a multi-chamber medical container. Background Art

[0002] Some multi-chamber bag-shaped containers such as multi-chamber medical containers respectively store powder and liquid, or a plurality of different types of liquids, and are configured to allow mixing of the powder and liquid, or the plurality of types of liquids upon use. For example, as a multi-chamber medical container for storing drugs for infusion therapy in the medical field, containers formed of a flexible film, in which different types of drugs are stored respectively in a plurality of drug chambers partitioned by a partition wall provided inside the container, are used. Examples of combinations of a plurality of drugs include those that may deteriorate over time when mixed and stored, such as an amino acid and glucose infusion, and an antibiotic and its solution.

[0003] As the resin material constituting the flexible film, those having heat resistance and water resistance that can withstand high-pressure steam sterilization are used, and examples thereof include vinyl chloride, ethylene-vinyl acetate copolymer, polyolefin, polyamide, polyester, polyethersulfone, cyclic polyolefin, cyclic polyolefin copolymer, ethylene-based elastomer, styrene-based elastomer, or mixtures of these resins, depending on the application. Each drug chamber of the multi-chamber medical container is formed by sealing two flexible films along the outer peripheral shape of each drug chamber by welding or the like. The partition wall provided between mutually adjacent drug chambers is a weak sealing section for partitioning that has lower sealing strength compared to the seal section along the outer peripheral shape of each drug chamber. Accordingly, at the partition portion, the two flexible films forming the multi-chamber medical container are sealed in a peelable state.

[0004] When administering intravenous therapy using a medical multi-chamber container, one of the drug chambers containing the liquid medication is pressed from the outside before use to apply internal pressure to the medication. This causes the two flexible films at the weak seal of the compartment to separate, breaking the partition and allowing the adjacent drug chambers on either side of the partition to communicate. As a result, the multiple medications contained in each drug chamber are aseptically mixed within the medical multi-chamber container. The mixed medication is then discharged through the discharge port via the needle and tubing of the infusion set and administered to the patient.

[0005] In intravenous infusion therapy using medical multi-chamber containers that mix multiple drugs, there is a risk of accidentally administering unmixed drugs without damaging the partitions of the medical multi-chamber container. Therefore, to prevent the administration of unmixed drugs, medical multi-chamber containers equipped with a weak seal section to temporarily obstruct communication between the drug chamber and the port have been disclosed (see, for example, Patent Documents 1 and 2).

[0006] Patent Document 1 discloses a weak seal portion for preventing inflow in which a narrow area in the center of the weak seal portion for preventing inflow is a curved seal portion in the shape of a convex arc toward the weak seal portion for partitioning the drug chamber. Patent Document 1 also states that films such as linear low-density polyethylene, ethylene propylene random copolymer, ethylene propylene block copolymer, and mixtures of polypropylene resin and styrene elastomer are preferred as films for medical multi-chamber containers, as they have excellent transparency and flexibility.

[0007] Patent Document 2 discloses that a second fused portion corresponding to a weak seal portion for preventing inflow is formed, and that the second fused portion has at least one corner, with the outer angle of the corner being 70 to 150°. Patent Document 2 also lists flexible resins as preferred resin materials for medical multi-chamber containers, which are obtained by blending styrene-based elastomers such as styrene-butadiene copolymers and styrene-ethylene-butylene-styrene block copolymers, or olefin-based elastomers such as ethylene-butene copolymers and ethylene-propylene copolymers, with polyethylene or polypropylene to make them flexible. It is stated that these are preferred because they are highly strong and flexible, have high heat resistance (especially heat resistance during sterilization) and water resistance, and have particularly excellent processability, which can reduce manufacturing costs.

[0008] The curved seal sections and corners of these weak seal sections designed to prevent inflow are the areas where the drug first reaches and stress concentrates when the weak seal section for partitioning peels off and the drug flows from the drug chamber on the side furthest from the port to the drug chamber on the side closer to the port, thus facilitating the initiation of peeling of the weak seal section that prevents inflow. [Prior art documents] [Patent Documents]

[0009] [Patent Document 1] Japanese Patent Publication No. 2016-202467 [Patent Document 2] Japanese Patent Publication No. 2005-40165 [Overview of the project] [Problems that the invention aims to solve]

[0010] The inventors of this invention investigated conventional medical multi-chamber containers such as those described in Patent Documents 1 and 2 and found the following problems. In a medical multi-chamber container like the one in Patent Document 1, when mixing drugs and peeling off the weak seal portion for preventing inflow to connect the drug chamber and the port, if the medical multi-chamber container is placed on a flat surface and the drug chamber is pressed down on from above by hand, the film around the weak seal portion for preventing inflow does not bend, and the liquid pressure is applied appropriately to the curved seal portion, so the weak seal portion for preventing inflow can be easily peeled off with good reproducibility. On the other hand, in medical settings, as shown in Figure 3, it is common to grasp both sides of the drug chamber 112A on the side of the container body 110 of the medical multi-chamber container 100 that is away from the port 114 with both hands and press down on the drug chamber 112A from both sides to separate the partitioning weak seal portion 113 and the inflow-blocking weak seal portion 115. In this case, as shown in Figure 4, deep folds 120 tend to form in the drug chamber 112B on the side closer to the port 114, extending vertically from around the center of the medical multi-chamber container 100 towards the curved seal portion 115a of the inflow-blocking weak seal portion 115. When such folds 120 form, the liquid pressure from the drug may not be sufficiently applied to the curved seal portion 115a of the inflow-blocking weak seal portion 115, making it difficult to separate the inflow-blocking weak seal portion 115.

[0011] Furthermore, when the aforementioned fold 120 reaches the weak seal portion 115 for preventing inflow, peeling is inhibited at that point. Applying further force to peel the weak seal portion 115 for preventing inflow eliminates the fold 120, and peeling of the weak seal portion 115 for preventing inflow begins. However, at the same time, excessive stress is locally applied to the part where the fold 120 reached the weak seal portion 115 for preventing inflow or to a part of its surroundings due to the subsequently applied force. As shown in Figure 8, in rare cases, one of the films 111 may tear in the peeled portion after the weak seal portion 115 for preventing inflow has been peeled, creating a hole 115c and causing the chemical to leak out. Note that the size, shape, and location of the hole 115c shown in Figure 8 are not limited to those shown. Furthermore, if excessive stress is applied to the weak seal portion 115 for preventing inflow, even if the film 111 does not tear and the weak seal portion 115 peels off, cohesive failure can cause the film 111 to be pulled, resulting in stringing where the resin is stretched out in a thread-like manner from the surface at the peeled portion. Even if stringing occurs due to cohesive failure, the film 111 does not tear and the contents do not leak, but it is considered a precursor to tearing.

[0012] Such problems, where creases and folds in the pharmacy chamber make it difficult to peel off the weak seal portion used to prevent inflow, or cause the film to tear, can also occur in the case of a weak seal portion used to prevent inflow that has corners, as described in Patent Document 2. In the case of a weak seal portion used to prevent inflow that has two corners, as described in Patent Document 2, two creases and folds extending toward each of the two corners are likely to form, which can lead to poor peeling of the weak seal portion used to prevent inflow or tearing of the film.

[0013] Furthermore, films made by blending various elastomers with polyolefins such as polyethylene and polypropylene, which are described as preferred materials in Patent Documents 1 and 2, tend to be highly flexible and less prone to creasing even after high-pressure steam sterilization. However, there is a concern that additives such as antioxidants contained in the polypropylene resin and elastomer may leach out. On the other hand, polyethylene resins, for example, can be used without additives, but their flexibility decreases after high-pressure steam sterilization, and they tend to develop deep creases and wrinkles. Furthermore, films that lose flexibility after high-pressure steam sterilization tend to retain the shape they had when sterilized, and creases and wrinkles tend to develop along that shape.

[0014] The main objective of the present invention is to provide a medical multi-chamber container that eliminates concerns about the elution of additive components, has excellent transparency, is less prone to creasing or folds even when the sides of the drug chamber are grasped with both hands and pressed inward during use, has a weak seal portion for preventing inflow that peels off easily, and suppresses tearing of the film. [Means for solving the problem]

[0015] The present invention may include the following embodiments. [1] A substantially rectangular container body having multiple drug chambers formed by sealing the periphery of overlapping films, and a drug discharge port attached to the periphery seal portion of the container body, The aforementioned film is a film whose main component is a polyethylene resin, The aforementioned multiple pharmacy rooms are separated by partitioning weak seal sections that allow adjacent pharmacy rooms to communicate with each other. The port is provided in the peripheral seal portion opposite to the partitioning weak seal portion in the drug chamber, which is surrounded by the partitioning weak seal portion and the peripheral seal portion. A medical multi-chamber container having a weak seal portion for temporarily preventing the inflow of a drug contained in the drug chamber into the port, wherein the drug chamber is provided with the port, In a plan view of the container body as seen from one planar side, the inflow-blocking weak seal portion includes a curved seal portion located in the central part, the edge opposite to the port being a convex arc toward the partitioning weak seal portion, and a first straight seal portion and a second straight seal portion, the edges of which extend linearly from both ends of the curved seal portion to the peripheral seal portions on both sides of the port. A medical multi-chambered container that satisfies the following conditions (1) to (4), where r (mm) is the radius of curvature of the arc of the edge of the curved seal portion, θ (°) is the central angle of the sector formed by the arc of the edge of the curved seal portion, A (mm) is the distance between the line connecting the intersection points of the edges of the first straight seal portion and the second straight seal portion and the peripheral seal portion and the position on the edge of the curved seal portion furthest from the line, B (mm) is the width dimension of the weak seal portion for preventing inflow, and W (mm) is the width dimension of the container body. 20 ≤ r ≤ 40 ···(1) θ > 100° ···(2) B / W ≤ 0.26 ···(3) 0.40 ≤ A / B ≤ 0.50 ···(4) [2] The medical multi-chamber container according to [1], wherein the first straight seal portion and the second straight seal portion are tapered toward the distal end. [3] The medical multi-chamber container according to [1] or [2], wherein when a content with a filling rate of 45% by volume relative to the total maximum storage capacity of the plurality of drug chambers is stored in the plurality of drug chambers, after the partition weak seal portion is peeled off and before the inflow blocking weak seal portion peels off, when the medical multi-chamber container is held so as to extend vertically with the port facing downward, a bulge C in the container thickness direction above the inflow blocking weak seal portion is 10 cm or less. Effects of the Invention

[0016] According to the present invention, there is provided a medical multi-chamber container which has no risk of elution of additive components, is excellent in transparency, is less prone to bending wrinkles even when held on both sides of a drug chamber with both hands and pressed inward during use, allows the inflow blocking weak seal portion to be peeled off easily, and can suppress tearing of a film. Brief Description of the Drawings

[0017] [Figure 1] It is a plan view showing a medical multi-chamber container according to an example of an embodiment. [Figure 2] It is an enlarged plan view showing a peripheral portion of an inflow blocking weak seal portion in a medical multi-chamber container according to an example of an embodiment. [Figure 3] It is a front view showing a state where both sides of the drug chamber on the side far from the port of the medical multi-chamber container are grasped and pressed inward, the partition weak seal portion is peeled off to mix drugs, and at the same time the inflow blocking weak seal portion is also peeled off to allow the drugs to flow into the port. [Figure 4] It is a front view showing a state where when both sides of the drug chamber on the side far from the port of the medical multi-chamber container are grasped and pressed inward, bending wrinkles extending vertically toward the inflow blocking weak seal portion occur in the drug chamber on the side close to the port. [Figure 5]This is a plan view showing an enlarged view of the area surrounding the weak seal portion used to prevent inflow in the medical multi-chamber container manufactured in Comparative Example 1. [Figure 6] This is a plan view showing an enlarged view of the area surrounding the weak seal portion used to prevent inflow in the medical multi-chamber container manufactured in Comparative Example 2. [Figure 7] This diagram shows a comparison of the weak seals used to prevent inflow in the medical multi-chamber container of Example 1, with the shape of the weak seal used to prevent inflow in the medical multi-chamber machine of Comparative Example 1 superimposed on the plan view of Example 1 using a dashed line. [Figure 8] This is a schematic plan view illustrating how, when further force is applied to a weak seal designed to prevent inflow, after the seal has been peeled off, one of the films tears and a hole is created in the peeled portion of the weak seal designed to prevent inflow. [Figure 9] (a) is a front view and (b) is a cross-sectional view of (a) II of a medical multi-chambered container, held in a position where the port is facing downwards and extending vertically. [Modes for carrying out the invention]

[0018] One embodiment of the present invention will be described based on the drawings. Note that the dimensions and other details shown in the following description are examples only, and the present invention is not necessarily limited to them. It can be implemented with appropriate modifications without altering its essence.

[0019] Figure 1 is a plan view showing a medical multi-chamber container according to one embodiment of the present invention. As shown in Figure 1, the medical multi-chamber container 1 comprises a container body 10 for containing the drug and a port 14 for discharging the drug.

[0020] The container body 10 of the medical multi-chamber container 1 is formed in a roughly rectangular shape when viewed from above, and is formed by overlapping two films 11, 11 and sealing a peripheral seal portion 17, a concave seal portion 16, a partitioning weak seal portion 13, and an inflow-preventing weak seal portion 15.

[0021] The container body 10 has two drug chambers 12A and 12B arranged in the longitudinal direction within a space surrounded by a peripheral seal portion 17, and partitioned by a partitioning weak seal portion 13. In the following description, in a roughly rectangular medical multi-chamber container 1, the direction in which the two drug chambers 12A and 12B are aligned is defined as the vertical direction Y, and the direction perpendicular to the vertical direction Y on the surface of the film 11 is defined as the width direction X.

[0022] The drug chambers 12A and 12B are formed by dividing a space in the container body 10, surrounded by a peripheral seal portion 17 where the periphery of two films 11 are sealed, into two sections vertically Y by a partitioning weak seal portion 13 that extends linearly in the width direction X. The drug chamber furthest from the port 14 is designated 12A, and the drug chamber closer to the port 14 is designated 12B.

[0023] The peripheral seal portion 17 is formed at both ends of the container body 10 in the width direction X and comprises lateral seal portions 17A, 17A extending in the vertical direction Y, and upper seal portions 17B and lower seal portions 17C formed at both ends of the container body 10 in the vertical direction Y and extending in the width direction X. In the example shown in Figure 1, the upper seal portion 17B and lower seal portion 17C are each formed with a wider seal width than the lateral seal portion 17A.

[0024] In the lateral sealing portions 17A, a recessed sealing portion 16 is formed in the middle of the vertical direction Y of 17A, which is roughly U-shaped and recessed toward the center in the width direction X, i.e., toward the inside of the container body 10. In each recessed sealing portion 16, the tip portion 16a that protrudes toward the center in the width direction X is formed to overlap with the partitioning weak sealing portion 13.

[0025] When H (mm) is the height of the concave seal portion 16 in the width direction X, i.e., the degree to which the concave seal portion 16 is recessed toward the inside of the container body 10 in the width direction X, and W (mm) is the width dimension of the container body 10, i.e., the length dimension in the width direction X, then 2H / W, which is the ratio of the sum of the heights 2H of the pair of concave seal portions 16, 16 to the width dimension W of the container body 10, is preferably 0.10 to 0.50, more preferably 0.15 to 0.45. If 2H / W is above the lower limit, it is less likely that an unopened portion will remain at the longitudinal end of the partitioning weak seal portion 13, and even if the medical multi-chamber container 1 is dropped, it is less likely that the bag will rupture from near the end of the unopened portion. If 2H / W is below the upper limit, it is easier to maintain a sufficient amount of contents in the drug chambers 12A and 12B.

[0026] The radius of curvature of the tip 16a of the concave sealing portion 16 is preferably 15 to 30 mm. If the radius of curvature is 15 mm or more, the bag is less likely to rupture even if the medical multi-chamber container 1 is dropped. If the radius of curvature is 30 mm or less, it is easier to maintain a sufficient amount of contents in the drug chambers 12A and 12B. The concave sealing portions 16, 16 shown in Figure 1 are symmetrical in the width direction X, but are not limited to this and may be asymmetrical.

[0027] In the example shown in Figure 1, a planned filling port portion 11a is formed on the left side of the upper seal portion 17B in the width direction X, projecting outward in the vertical direction Y, and intended to be used as a filling port for the drug chamber 12A. To the left of the planned filling port portion 11a in the width direction X of the upper seal portion 17B, one first unadhered portion 11b is formed where the overlapping films 11, 11 are not bonded to each other, and to the right of the planned filling port portion 11a, three first unadhered portions 11b are formed side by side in the width direction X. In the upper seal portion 17B, in the central part in the width direction where the overlapping films 11 are bonded to each other, a suspension hole 18 is formed that penetrates the two films 11, 11. This suspension hole 18 is used when the medical multi-chamber container 1 is suspended for use, etc. To fill the drug, a portion of the planned filling port 11a is cut, and after filling the drug, the seal used to seal the planned filling port 11a may be a seal that is continuous with the upper sealing portion 17B, or it may be a seal that is only at the upper end.

[0028] In the right portion of the lower seal portion 17C in the width direction X, a planned filling port portion 11c is formed, which protrudes outward in the vertical direction Y and is intended to be used as a filling port for the drug chamber 12B. To the right of the planned filling port portion 11c in the width direction X of the lower seal portion 17C, one second unadhered portion 11d is formed where the overlapping films 11, 11 are not bonded to each other, and to the left of the planned filling port portion 11c, two second unadhered portions 11d are formed side by side in the width direction X. The planned filling port can be located anywhere on the container body 10, and its number is not limited to two. Furthermore, a portion of the planned filling port 11c may be cut to allow for drug filling, and the seal used to seal the planned filling port 11c after drug filling may be a seal that is continuous with the lower seal portion 17C, or it may be a seal that is only at the lower end.

[0029] Port 14 is located in the lower seal portion 17C on the opposite side of the partitioning weak seal portion 13 in one of the pharmacy chambers 12B. Port 14 is located in the center of the width direction X in the lower seal portion 17C. Port 14 is sandwiched and fixed between two films 11, 11 in the lower seal portion 17C.

[0030] Port 14 is used for injecting and discharging drugs and is a passage that allows access to the inside of the container from outside. Port 14 is provided so that the central axis of the passage formed by port 14 coincides with the vertical direction when the medical multi-chamber container 1 is suspended by the suspension hole 18. Port 14 is made of an injection-molded thermoplastic resin and its opening is sealed with an elastic material such as rubber (not shown) that can be punctured to allow needle insertion.

[0031] The partitioning weak seal section 13 is formed in a straight strip shape along the width direction X. In the partitioning weak seal section 13, two overlapping films 11, 11 are sealed to each other in a peelable manner. The partitioning weak seal section 13 isolates the two drug chambers 12A and 12B in a way that allows them to communicate. In the state before use, the partitioning weak seal section 13 isolates the drug chambers 12A and 12B and blocks them from each other. When using, the partitioning weak seal section 13 can be peeled off by pressing an adjacent drug chamber 12A or drug chamber 12B from the outside and increasing its internal pressure. When the partitioning weak seal section 13 is peeled off, the drug chambers 12A and 12B become connected.

[0032] In this example, the partitioning weak seal portion 13 passes through the tip portions 16a, 16a of the pair of concave seal portions 16, 16 on the left and right, and reaches from one lateral seal portion 17A to the other lateral seal portion 17A. The reason for this is as follows. In a weak seal mold having a linear heating section for manufacturing a compartmental weak seal section 13, the longitudinal central portion of the linear heating section is stably maintained at a constant temperature, whereas the ends of the heating section are the edges of the mold and are therefore susceptible to external influences, making it difficult to maintain a constant temperature, which can lead to greater variation in peel strength. However, by making the heating section of the weak seal mold long enough to reach from one lateral seal section 17A to the other lateral seal section 17A of the compartmental weak seal section 13, or longer, the compartmental weak seal section 13 can be formed using only the longitudinal central portion which is stably maintained at a constant temperature. This makes it possible to create a compartmental weak seal section 13 that does not experience unintended peeling due to impacts such as dropping, and that exhibits sufficient strength to easily connect the drug chambers 12A and 12B when necessary. Furthermore, the partitioning weak seal portion 13 may be formed from the tip 16a of one concave seal portion 16 to the tip 16a of the other concave seal portion 16, so as not to pass through the tip 16a of the concave seal portions 16, 16.

[0033] The width dimension D1 of the partition weak seal section 13 is not particularly limited and can be set to, for example, 5 to 20 mm.

[0034] For the partitioning weak seal section 13, the T-shaped peel strength measured at a tensile speed of 300 mm / min in accordance with JIS K6854-3 is preferably 1 to 8 N / 10 mm width, and more preferably 1.5 to 5 N / 10 mm width. When the drug chamber 12A or drug chamber 12B is pressed from the outside, the weak sealing portion 13 for partitioning is peeled off and communication is established. The communication strength is preferably 200N to 800N, and more preferably 300N to 700N. By setting it within this range, there is an advantage that excessive force is not required during use, and the weak sealing portion 13 for partitioning can be peeled off without damaging the container body 10.

[0035] The peel strength of the partitioning weak seal portion 13 may be constant in the width direction X of the container body 10, but it is also preferable to vary it in the width direction X of the container body 10. For example, it is preferable to make the peel strength of the central portion 13a in the width direction X of the partitioning weak seal portion 13 higher, and the peel strength of both ends 13b and 13c in the width direction X lower than that of the central portion 13a. Specifically, it is preferable to make the peel strength of both ends 13b and 13c 20 to 80% of the peel strength of the central portion 13a. By doing so, the remaining unpeeled portions at both ends 13b and 13c of the partitioning weak seal portion 13 after connection can be minimized or eliminated. If unpeeled portions remain, the remaining ends of the partitioning weak seal portion 13 become stress concentration points when the medical multi-chamber container 1 is dropped, making the medical multi-chamber container 1 more prone to rupture. By lowering the peel strength of both ends 13b and 13c in the width direction X of the partitioning weak seal portion 13, it becomes less likely for unpeeled portions to remain, and even if they do remain, the peel strength is lower than that of the central part 13a in the width direction X, resulting in a weak seal portion that is more easily peeled. This makes it possible to prevent the partitioning weak seal portion 13 from becoming a stress concentration point that could lead to rupture as much as possible. This makes it easier to prevent the medical multi-chamber container 1 from rupturing.

[0036] The method for increasing the peel strength of the central portion 13a in the width direction X and decreasing the peel strength of both ends 13b and 13c in the width direction X in the partition weak seal portion 13 is not particularly limited. For example, one method is to set the heat sealing temperature during the manufacture of the partition weak seal portion 13 so that it is high in the central portion 13a and low in both ends 13b and 13c; one is to adjust the sealing pressure of the central portion 13a to be high and the sealing pressure of both ends 13b and 13c to be low by the shape of the sealing mold; and one is to increase the amount of heat received per unit time in the central portion 13a and decrease the amount of heat received per unit time in both ends 13b and 13c by the sealing pattern of the sealing mold.

[0037] When the weak sealing portion 13 for partitioning is peeled off by pressing the pharmaceutical chamber 12A from the outside to increase the internal pressure of the pharmaceutical chamber 12A, if the intention is to easily peel off the weak sealing portion 15 for preventing inflow in a continuous manner, it is preferable to make the peeling strength of the central portion 13a of the weak sealing portion 13 for partitioning lower than the peeling strength of the ends 13b and 13c. In this way, when the central part 13a of the partitioning weak seal part 13 peels off, the drug in the drug chamber 12A concentrates in the central part 13a and flows more easily into the center of the width direction X of the drug chamber 12B. The pressure of the drug that has flowed into the drug chamber 12B acts on the inflow-blocking weak seal part 15 located in the center of the width direction X, making it easier for the inflow-blocking weak seal part 15 to peel off.

[0038] The method for reducing the peel strength of the central portion 13a in the width direction X and increasing the peel strength of both ends 13b and 13c in the width direction X in the partition weak seal portion 13 is not particularly limited. For example, one method is to set the heat sealing temperature during the manufacture of the partition weak seal portion 13 so that it is low in the central portion 13a and high in both ends 13b and 13c; one is to adjust the sealing pressure of the central portion 13a to be low and the sealing pressure of both ends 13b and 13c to be high by the shape of the sealing mold; and one is to reduce the amount of heat received per unit time in the central portion 13a and increase the amount of heat received per unit time in both ends 13b and 13c by the sealing pattern of the sealing mold.

[0039] The weak seal portion 15 for preventing inflow is formed in the drug chamber 12B where the port 14 is located, surrounding the port 14. By temporarily blocking the inflow of drug into the port 14 with the weak seal portion 15 for preventing inflow, it is prevented that the drug before mixing is administered to the patient. The area surrounded by the lower seal portion 17C and the weak seal portion 15 for preventing inflow, where the port 14 is located, is called the small chamber 19.

[0040] As shown in Figure 2, the inflow-blocking weak seal portion 15 includes a curved seal portion 15b located in the center, where the edge 15a on the opposite side of the port 14 is in the shape of a convex arc toward the partitioning weak seal portion 13, and a first straight seal portion 15c and a second straight seal portion 15d, where the edge 15a extends linearly from both ends of the curved seal portion 15b to the lower seal portions 17C on both sides of the port 14. The edge 15a of the weak seal section 15 for preventing inflow, on the side opposite to the port 14, has a smooth, cornerless shape that combines an arc and a straight line, from the end of the first straight seal section 15c opposite to the curved seal section 15b to the end of the second straight seal section 15d opposite to the curved seal section 15b.

[0041] The curved seal portion 15b of the weak seal portion 15 for preventing inflow is formed continuously between the upper ends of the first straight seal portion 15c and the second straight seal portion 15d. The curved seal portion 15b is formed to be convex upward. In the weak seal portion 15 for preventing inflow, the curved seal portion 15b is located at the position closest to the weak seal portion 13 for partitioning. The curved seal portion 15b is the first point that the mixed drug reaches after the weak seal portion 13 for partitioning has peeled off and flowed from the drug chamber 12A into the drug chamber 12B, and it is a point where stress concentrates, and it can be the starting point for peeling off the weak seal portion 15 for preventing inflow.

[0042] In the example shown in Figures 1 and 2, the curved seal portion 15b of the weak seal portion 15 for preventing inflow is symmetrical with respect to a straight line parallel to the vertical direction Y that passes through the center of the width direction X of the weak seal portion 15 for preventing inflow. Furthermore, the first straight seal portion 15c and the second straight seal portion 15d of the weak seal portion 15 for preventing inflow are formed symmetrically with respect to a straight line parallel to the vertical direction Y that passes through the center of the width direction X of the weak seal portion 15 for preventing inflow. The first straight seal portion 15c and the second straight seal portion 15d are inclined with respect to the vertical direction Y such that the distance between them increases as they approach the lower seal portion 17C.

[0043] In the weak seal section 15 for preventing inflow, let r (mm) be the radius of curvature of the arc of the edge 15a of the curved seal section 15b, and let θ (°) be the central angle of the sector formed by the arc of the edge 15a of the curved seal section 15b. Also, let A (mm) be the height of the weak seal section 15 for preventing inflow, i.e., the distance between the line k connecting the intersection points of the edges 15a of the first straight seal section 15c and the second straight seal section 15d and the lower seal section 17C, and the height dimension of the weak seal section 15 for preventing inflow, i.e., the distance from the line k on the edge 15a of the curved seal section 15b. Let B (mm) be the width dimension of the weak seal section 15 for preventing inflow, i.e., the distance between the intersection points of the edges 15a of the first straight seal section 15c and the second straight seal section 15d and the lower seal section 17C. Also, let W (mm) be the width dimension of the container body 10. In this case, the medical multi-chamber container 1 according to the embodiment satisfies the following conditions of formulas (1) to (4). 20 ≤ r ≤ 40 ···(1) θ > 100° ···(2) B / W ≤ 0.26 ···(3) 0.40 ≤ A / B ≤ 0.50 ···(4)

[0044] The following explains why the weak seal portion 15 for preventing inflow is designed to satisfy conditions (1) to (4). As described above, as shown in Figure 3, when both sides of the drug chamber 112A on the side of the container body 110 of the medical multi-chamber container 100 that is away from the port 114 are grasped with both hands and pressed in, as shown in Figure 4, if a fold 120 extending in the approximately vertical Y direction is formed toward the curved seal portion 115a of the weak seal portion 115 for preventing inflow, then sufficient hydraulic pressure is not applied to the curved seal portion 115a, and the weak seal portion 115 for preventing inflow does not peel off easily. Furthermore, when the fold 120 reaches the curved seal portion 115a of the weak seal portion 115 for preventing inflow, peeling is inhibited at the point where the fold 120 reaches, and the curved seal portion 115a does not peel off smoothly. From that state, if an even greater force is applied to try to peel off the curved seal portion 115a, the fold 120 is eliminated and peeling of the curved seal portion 115a begins. However, at the same time, excessive stress is applied locally to the portion of the curved seal portion 115a that the fold wrinkle 120 reached or to a part of its surrounding area due to the force applied afterward, and as shown in Figure 8, there is a risk that one of the films 111 will tear in the peeled portion after the curved seal portion 115a has been peeled off.

[0045] Here, the inventors have found that when a relatively large medical multi-chamber container 100 with a total liquid volume of 2L or more is grasped from the sides with both hands and pressed inward as shown in Figure 3, the amount of film 111 being crushed from both sides is greater than when a smaller medical multi-chamber container with a total liquid volume of about 1L is pressed in the same way. As a result, the film 111 of the drug chamber 112B on the side closer to the port 114 of the medical multi-chamber container 100 tends to develop concave folds 120 extending approximately along the vertical direction Y toward the contents side, which can lead to tearing of the film 111.

[0046] Furthermore, the inventors have found that, in addition to the width dimension of the medical multi-chamber container 100, when the total volume of contents is large, such as 2L or more, or when the area of ​​the small chamber 119 surrounded by the weak seal portion 115 for preventing inflow and the peripheral seal portion 117 is large, and the area of ​​the drug chamber 112B is small, pressing the container body 110 and causing a large bulge in the thickness direction of the container before the weak seal portion 115 for preventing inflow peels off tends to create deep folds 120, which can lead to tearing of the film 111. Specifically, in a container body 110 with a large total liquid volume of 2L or more and made of a relatively rigid film 111 (described later), if, in the state M shown in Figures 9(A) and (B), the maximum bulge C in the container thickness direction above the weak seal portion 115 for preventing inflow, that is, the horizontal distance between the inner surfaces of the container body 110 at the most bulging position, is greater than 10cm, then when the sides of the drug chamber are grasped with both hands and pressed from both sides, folds 120 tend to form easily. For this reason, it is preferable that the maximum bulge C in the container thickness direction above the weak seal portion 115 for preventing inflow in state M is 10cm or less. Therefore, when the total volume of contents is large, such as 2L or more, it is necessary to avoid making the width dimension of the medical multi-chamber container 100 too large, and to suppress the maximum bulge C in the thickness direction of the container. However, when the total volume of contents is large, the medical multi-chamber container 100 requires a correspondingly large capacity, depending on the filling rate of the contents, which tends to increase the width dimension and makes it difficult to suppress bulging in the thickness direction of the container.

[0047] Furthermore, the inventors have found that regardless of the width of the medical multi-chamber container 100 or the total volume of liquid contents, if there is a part that acts as a corner in the weak seal portion 115 for preventing inflow, folds 120 tend to form towards that point, and these folds 120 tend to reach the weak seal portion 115 for preventing inflow, which can lead to tearing of the film 111. Furthermore, when the total volume of the contents is relatively small, around 1 liter, if a medical double-chamber container 100 with the same width dimensions as a medical double-chamber container 100 with a total volume of 2 liters contains 1 liter of drug solution, the maximum bulge C in the thickness direction of the container in state M will be small and will not reach 10 cm. Therefore, in this case, when the sides of the drug chamber are grasped with both hands and pressed from both sides, a large amount of film 111 will be crushed from both sides, but the probability of folds and wrinkles 120 occurring will be low. However, the capacity of the medical container 100 is too large relative to the total volume of the contents, making it inconvenient to use, and the amount of film used will also increase, making it impractical. For this reason, when the total volume of liquid contents is small, such as 1 L or less, a medical multi-chamber container 100 with a relatively small width is used. In this case, the maximum bulge C in state M will be large, but the amount of film 111 that is crushed from both sides when the sides of the drug chamber are grasped with both hands and pressed from both sides is small, so the probability of folds 120 occurring is low. However, even in this case, even if the amount of film 111 that is crushed from both sides is small, if the maximum bulge C in state M exceeds 10 cm, there is a possibility that folds 120 will occur. Furthermore, if a crease 120 occurs, and there is a corner-like portion in the weak seal portion 115 for preventing inflow, the crease 120 is more likely to reach that point, potentially leading to tearing of the film 111.

[0048] In contrast, in the medical multi-chamber container 1 according to one embodiment, regardless of the width dimension of the medical multi-chamber container 1 or the total liquid volume of its contents, the radius of curvature r of the arc of the edge 15a of the curved seal portion 15b and the central angle θ of the sector formed by the arc of the edge 15a of the curved seal portion 15b are controlled to satisfy conditions (1) and (2). As a result, the curved seal portion 15b is less likely to function as a corner, and even when both sides of the drug chamber 12A are grasped and pressed inward, folds and wrinkles are less likely to occur in the drug chamber 12B, and even if folds and wrinkles do occur, they are less likely to reach the weak seal portion 15 for preventing inflow. As a result, sufficient liquid pressure is applied to the curved seal portion 15b, making it easier for the weak seal portion 15 for preventing inflow to peel off, and excessive localized stress is less likely to be applied to the curved seal portion 15b, thus suppressing tearing of the film 11. Furthermore, when the weak seal portion 15 for preventing inflow peels off, stringing due to cohesive failure, which can lead to tearing of the film 11, is less likely to occur.

[0049] Regarding condition (1), the radius of curvature r of the arc of the edge 15a of the curved seal portion 15b is 20 to 40 mm, and preferably 25 to 35 mm.

[0050] Regarding condition (2), the central angle θ of the sector formed by the arc of the edge 15a of the curved seal portion 15b is greater than 100°, preferably 130° or more, preferably less than 180°, and more preferably 150° or less. If the radius of curvature r and the central angle θ are greater than or equal to the lower limit, the curve of the arc is gentle, and the curved seal portion 15b is less likely to function as a corner. Even if the container body 10 is pressed inward by grasping both sides of the drug chamber 12A, it is less likely that folds will form in the drug chamber 12B that reach the curved seal portion 15b. As a result, the weak seal portion 15 for preventing inflow is more easily peeled off, and tearing of the film 11 of the container body 10 can be suppressed. If the radius of curvature r and the central angle θ are less than or equal to the upper limit, the liquid pressure from the drug mixing easily puts stress on the curved seal portion 15b, and the curved seal portion 15b becomes the starting point for peeling, allowing the weak seal portion 15 for preventing inflow to be easily peeled off. In addition, the lower seal portion 17C side of the first straight seal portion 15c and the second straight seal portion 15d does not face inward but has a flared shape, making it easier for the weak seal portion 15 for preventing inflow to peel off to the ends of the first straight seal portion 15c and the second straight seal portion 15d.

[0051] Furthermore, the edge of the curved seal portion 15b on the port 14 side may have the same shape as edge 15a, or it may have a different shape from edge 15a, so that the width of the curved seal portion 15b is the same along its entire length. For example, the edge of the curved seal portion 15b on the port 14 side may be straight. It is preferable that the edge of the curved seal portion 15b on the port 14 side has the same shape as edge 15a, as this makes it easier to peel off.

[0052] Furthermore, in order to prevent creases from forming when the container body 10 is pressed from both sides, or to prevent creases from reaching the weak seal portion 15 for preventing inflow, it is necessary to control the height dimension A and width dimension B of the weak seal portion 15 for preventing inflow, in addition to the radius of curvature r and central angle θ at the edge 15a of the curved seal portion 15b, within an appropriate range.

[0053] Regarding condition (3), the narrower the width dimension B of the weak seal portion 15 for preventing inflow, the smaller the volume of the small chamber 19 surrounded by the weak seal portion 15 for preventing inflow, and the larger the volume of the drug chamber 12B. Therefore, when the medical multi-chamber container 1 is pressed, the bulge of the drug chamber 12B in the thickness direction of the container becomes smaller, and deep folds tend to be less likely to occur. From this viewpoint, the ratio B / W, which is the ratio of the width dimension B of the weak seal portion 15 for preventing inflow to the width dimension W of the container body 10, is 0.26 or less, and preferably 0.24 or less. If B / W is less than or equal to the above upper limit, even if the drug chamber 12A of the container body 10 is grasped on both sides and pressed inward, folds are less likely to form in the drug chamber 12B, so the weak seal portion 15 for preventing inflow is easier to peel off, and tearing of the film 11 of the container body 10 can be suppressed. Furthermore, B / W is preferably 0.15 or more, and more preferably 0.20 or more. If the B / W ratio is equal to or greater than the aforementioned lower limit, it becomes easier to attach the port 14 to the container body 10 during the manufacturing stage of the medical multi-chamber container 1.

[0054] Furthermore, regarding condition (4), the narrower the width dimension B of the weak seal portion 15 for preventing inflow and the higher the height dimension A, the sharper the curve of the curved seal portion 15b becomes, making it easier for the curved seal portion 15b to act as a corner. This tends to cause creases that reach the curved seal portion 15b, which can lead to poor peeling of the weak seal portion 15 for preventing inflow and tearing of the film 11. To suppress this and prevent the curved seal portion 15b from functioning as a corner, and to make the curved seal portion 15b the starting point for peeling, the ratio A / B of the height dimension A to the width dimension B of the weak seal portion 15 for preventing inflow is 0.50 or less, and preferably 0.48 or less. If A / B is below the above upper limit, even if both sides of the drug chamber 12A of the container body 10 are grasped and pressed inward, creases are less likely to form in the drug chamber 12B, making it easier to peel off the weak seal portion 15 for preventing inflow and suppressing tearing of the film 11 of the container body 10. Furthermore, since the port 14 is located in the small chamber 19, from the viewpoint of securing a certain area in the region of the small chamber 19 surrounded by the weak seal portion 15 for preventing inflow and the lower seal portion 17C, A / B should be 0.40 or more, and preferably 0.43 or more. Furthermore, even if the shape of the weak seal portion 15 for preventing inflow satisfies conditions (1) to (4), it is preferable that, when the weak seal portion 13 for partitioning is peeled off and the weak seal portion 15 for preventing inflow is peeled off, the medical multi-chamber container 1 is held in a state M where the port 14 is facing downwards and extends vertically, and the bulge C in the container thickness direction above the weak seal portion 15 for preventing inflow is 10 cm or less, as this further reduces the likelihood of folds forming in the drug chamber 12B.

[0055] When the contents of the multiple drug chambers 12A and 12B are filled with contents at a filling rate of 30 to 60% of the total maximum capacity of the multiple drug chambers 12A and 12B, the partitioning weak seal portion 13 and the inflow-blocking weak seal portion 15 are easily peeled off with a single press. From the viewpoint of preventing the formation of folds and wrinkles in the drug chamber 12B, when the medical multi-chamber container 1 is filled with contents at a filling rate of 45% of the volume, at the stage when the partitioning weak seal portion 13 is peeled off and the inflow-blocking weak seal portion 15 is peeled off, in a state M in which the medical multi-chamber container 1 is held so that it extends vertically with the port 14 facing downwards, the distance between the inner surfaces of the container body 110 in the horizontal direction at the most bulging position on the container body 10, i.e., the bulge C above the inflow-blocking weak seal portion 15, is preferably 10 cm or less, and more preferably 8 cm or less. Furthermore, in a medical multi-chamber container 1 containing the contents of the above-mentioned filling ratio, it is preferable that the bulge C be small in order to prevent folds and wrinkles from forming in the drug chamber 12B. However, if the bulge C is too small, the liquid pressure applied to the weak seal portion 15 for preventing inflow will be small, making it difficult to peel off. Therefore, the bulge C may be 3 cm or more, or 5 cm or more.

[0056] The filling rate of the contents relative to the total maximum capacity of the multiple drug chambers 12A and 12B is preferably 30 to 60% by volume. If the above filling rate exceeds 60% by volume, the risk of the medical multi-chamber container 1 rupturing or leaking increases, and it is undesirable because the possibility of unintentional delamination or damage to the partitioning weak seal portion 13 or the inflow-blocking weak seal portion 15 increases, especially if impact is applied during transport. Also, if the above filling rate is less than 30% by volume, the liquid pressure applied to the partitioning weak seal portion 13 and the inflow-blocking weak seal portion 15 becomes small, making delamination difficult, which is undesirable.

[0057] In the example shown in Figures 1 and 2, the first straight seal portion 15c and the second straight seal portion 15d extend diagonally in a straight line from a distanced position in the width direction X, so that their distance from each other gradually decreases toward the center upwards. The angle θ2 between the first straight seal portion 15c and the second straight seal portion 15d and the straight line k is preferably 45° or more and 75° or less. The upper ends of the first straight seal portion 15c and the second straight seal portion 15d are continuous with the curved seal portion 15b. In a preferred example, as in this embodiment, the first straight seal portion 15c and the second straight seal portion 15d have a tapered shape toward the lower seal portion 17C. If the first straight seal portion 15c and the second straight seal portion 15d have such a tapered shape, it is less likely that unpeeled portions will remain on the lower seal portion 17C side of the first straight seal portion 15c and the second straight seal portion 15d during use, and it is easier to peel them to the tip, thereby preventing the flow of the drug into the port 14 from being obstructed by the unpeeled portions.

[0058] The seal width dimension at the point where the first straight seal portion 15c and the second straight seal portion 15d reach the lower seal portion 17C is preferably 5 mm or more. If the seal width dimension is 5 mm or more, it is easier to suppress the unintentional peeling of the first straight seal portion 15c and the second straight seal portion 15d due to the load applied during transportation.

[0059] Furthermore, the first straight sealing portion 15c and the second straight sealing portion 15d are not limited to a shape that tapers towards the lower sealing portion 17C, but may have the same sealing width from the end on the curved sealing portion 15b side to the end on the lower sealing portion 17C side.

[0060] The film 11 that constitutes the container body 10 will be described below. Film 11 is a film whose main component is polyethylene resin. However, "a film whose main component is polyethylene resin" means that the ratio of the thickness of the polyethylene resin layer to the total thickness of film 11 is 50% or more, preferably 70% or more, more preferably 80% or more, and may be 100%.

[0061] Films made by blending various elastomers with polyolefins such as polyethylene and polypropylene tend to exhibit excellent flexibility and resistance to creasing even after high-pressure steam sterilization, but they have poor transparency. Furthermore, polypropylene resin films and elastomers contain additives such as antioxidants, and there are concerns that these additives may leach out. On the other hand, polyethylene resin films can be used with little to no additives such as antioxidants, eliminating concerns about the leaching of additive components, and offering excellent transparency. However, they tend to become less flexible and relatively rigid after high-pressure steam sterilization, making them prone to creasing and folds. Furthermore, the reduced flexibility after high-pressure steam sterilization means that the film tends to retain its shape from the time of sterilization, and creasing and folds tend to form along that shape. Thus, in the medical multi-chamber container 1, since the film 11 contains polyethylene resin film, the material of the film 11 makes it prone to creasing and folds in the drug chamber 12B when the container body 10 is pressed in from both sides. However, this can be suppressed by providing a weak seal portion 15 for preventing inflow that satisfies the above conditions (1) to (4).

[0062] Examples of polyethylene resins used in film 11 include high-density polyethylene, low-density polyethylene, and linear low-density polyethylene. Polyethylene resins can be used without additives and have excellent hygiene properties.

[0063] The film 11 may be a single-layer film of polyethylene resin film, or it may be a multilayer film containing at least polyethylene resin film. The polyethylene resin contained in each layer of the single-layer film and the multilayer film may be one type or two or more types.

[0064] When film 11 is a single-layer film, a linear low-density polyethylene film is preferred due to its excellent transparency and flexibility.

[0065] If film 11 is a multilayer film, it may be a multilayer film made of various polyethylene-based resins. Alternatively, it may be a multilayer film containing other resins in which the proportion of the thickness of layers other than the polyethylene-based resin layer to the total thickness of film 11 is less than 50%. For example, a multilayer film can be used in which the inner layer is a polyethylene-based resin film and another film other than the polyethylene-based resin film is laminated as the outer layer. For the outer layer, a heat-resistant resin film such as polyamide, polypropylene, or polyester can be used to reduce damage to the surface of film 11 due to heating such as heat sealing or high-pressure steam sterilization during the manufacturing stage of the medical multi-chamber container 1, and to facilitate bag making by high-temperature, short-time heat sealing.

[0066] In the case of multilayer films, an adhesive resin layer may be provided between the layers as needed, and a multilayer film may be used in which a heat-resistant resin such as polyamide, polypropylene, or polyester is used for the outer layer and a polyethylene-based resin for the inner layer, manufactured by multilayer co-extrusion molding using a T-die, water cooling, or air cooling inflation. From the viewpoint of transparency and hygiene, a multilayer film manufactured by water cooling inflation molding is preferred. In this case, the inner layer of polyethylene-based resin may be a single layer or multiple layers. A multilayer film may also be formed by arranging an outer layer of stretched polyamide film, stretched polypropylene film, or stretched polyethylene terephthalate film, applying an adhesive to its inner surface, and laminating it with an inner layer of polyethylene resin film.

[0067] The total thickness of the film 11 is preferably 5 to 500 μm, and more preferably 50 to 300 μm. If the total thickness of the film 11 is greater than or equal to the lower limit, the medical multi-chamber container 1 is less likely to rupture during transport. If the total thickness of the film 11 is less than or equal to the upper limit, the drainage of the drug from the port 14 is excellent.

[0068] Polyethylene resin is one example of a material used for port 14. Examples of polyethylene resins used in port 14 include high-density polyethylene, low-density polyethylene, and linear low-density polyethylene. Polyethylene resins can be used without additives and have excellent hygiene properties. The polyethylene resin contained in port 14 may be of one type or two or more types.

[0069] Although embodiments of the medical multi-chamber container according to the present invention have been described above, the present invention is not limited to the above embodiments and can be modified as appropriate without departing from the spirit of the invention. For example, in the medical multi-chamber container 1, the container body 10 was divided into two drug chambers 12A and 12B by one partitioning weak seal section 13, but it may be divided into three or more drug chambers by two or more partitioning weak seal sections 13.

[0070] The weak seal portion 15 for preventing inflow is formed by sealing two overlapping films 11, 11. However, at least one of the two films 11, 11 may be a linear seal with one or more grooves formed along the direction in which the weak seal portion 15 extends, or a dot seal with multiple recesses formed along the direction in which the weak seal portion 15 extends. In this case, both of the two films 11, 11 may be linear seals, both may be dot seals, or one may be a linear seal and the other a dot seal. Furthermore, the weak seal portion 15 for preventing inflow may be a seal of a shape other than a linear seal or a dot seal.

[0071] Furthermore, it is possible to replace the components in the above-described embodiments with well-known components as appropriate, without departing from the spirit of the present invention. [Examples]

[0072] The present invention will be specifically described below with reference to examples, but the present invention is not limited to the following description.

[0073] [Example 1] A multilayer film 11 was manufactured by co-extrusion inflation molding using an adhesive resin, with a polyethylene-based resin as the inner layer and polyamide 11 as the outer layer to enhance heat resistance. The inner layer consisted of two layers: layer A, made of a mixed resin containing linear low-density polyethylene resin and high-density polyethylene resin in a mass ratio of 8:2, and layer B, the innermost layer made of high-density polyethylene resin. The thickness of the film 11, from the outside in, was 15 μm for the outer layer, 20 μm for the adhesive resin layer, 200 μm for layer A, and 15 μm for layer B. This film 11 is a film in which more than 80% of the total thickness is made of polyethylene-based resin.

[0074] Using the multilayer film described above as film 11, 800 medical multi-chamber containers 1, as illustrated in Figures 1 and 2, were manufactured. The peel strength of the weak seal portion 15 for preventing inflow was adjusted to 7 N / mm. In addition, water was filled into each of the drug chambers 12A and 12B. The total liquid volume of each drug chamber 12A and 12B was 2020 mL. The container body 10 has a width W of 300 mm and a vertical dimension of 419.5 mm. The weak seal section 15 for preventing inflow has a radius of curvature r of the arc of the edge 15a of the central curved seal section 15b of 30 mm, a central angle θ of the sector formed by the said arc of 130°, a height A of 32 mm, and a width B of 72 mm, with a B / W ratio of 0.24 and an A / B ratio of 0.44. The first straight seal section 15c and the second straight seal section 15d are tapered, and the seal width dimension at the position where it reaches the lower seal section 17C is 5.6 mm.

[0075] [Comparative Example 1] Using the same film 11 as in Example 1, 800 bags of the medical multi-chamber container 201 illustrated in Figure 5 were manufactured. The medical multi-chamber container 201 had the same configuration as the medical multi-chamber container 1 of Example 1, except that in the weak seal section 15 for preventing inflow, the central angle θ of the sector formed by the arc of the edge 15a of the central curved seal section 15b was 100°, the height dimension A was 35 mm, the width dimension B was 90 mm, B / W was 0.30, A / B was 0.38, and the seal width of the first straight seal section 15c and the second straight seal section 15d was kept constant to the tip.

[0076] [Comparative Example 2] Using the same film 11 as in Example 1, 800 bags of the medical multi-chamber container 301 illustrated in Figure 6 were manufactured. The medical multi-chamber container 301 had the same configuration as the medical multi-chamber container 1 of Example 1, except that the weak seal portion 15 for preventing inflow was changed to a trapezoidal shape having a third straight seal portion 15e extending in the width direction X instead of the central curved seal portion 15b, the height dimension A was set to 32 mm, the width dimension B to 73 mm, and the B / W ratio was set to 0.24 and A / B ratio to 0.44.

[0077] [evaluation] 800 medical multi-chamber containers manufactured in each example were autoclaved at 110°C to obtain evaluation samples. Subsequently, for each of the 800 samples, the drug chamber 12A on the side furthest from the port 14 was grasped from both sides and pressed in, and the surface of the drug chamber 12B on the side closer to the port 14 was visually observed to count the number of samples in which folds and wrinkles reaching the weak seal portion 15 for preventing inflow occurred. The number of samples in which the film 11 tore and the bag ruptured was also counted. Furthermore, the number of samples in which stringing due to cohesive failure occurred at the peeled-off portion when the weak seal portion 15 for preventing inflow was peeled off was also counted. The results are shown in Table 1.

[0078] [Table 1]

[0079] In Example 1, which had a weak seal portion for preventing inflow that met conditions (1) to (4), no folds or wrinkles extending along the approximately vertical Y direction to the curved seal portion occurred, no bags ruptured due to film tearing occurred at all, and the weak seal portion for preventing inflow peeled off smoothly in all samples. In addition, the number of bags that exhibited stringing due to cohesive failure, which could lead to film tearing, was small, at only 10 bags.

[0080] In Comparative Example 1, where the central angle θ in the weak seal portion for preventing inflow was small, the B / W ratio was large, and the A / B ratio was small, and conditions (2) to (4) were not met, folds extending roughly along the vertical Y direction occurred in 430 bags, nearly 54% of the total samples, and reached the curved seal portion. In 8 bags, one of the films tore at the peeled portion after the weak seal portion for preventing inflow was removed, resulting in the bags rupturing. In addition, stringing due to cohesive failure, which led to tearing, occurred in 142 bags, which was more than 17% of the samples where folds reached the curved seal portion. Figure 7 shows a superimposed comparison of the shapes of the weak seal portion for preventing inflow in the medical multi-chamber container of Example 1 and the weak seal portion for preventing inflow in the medical multi-chamber machine of Comparative Example 1. Due to these differences in shape, the present invention shown in Example 1 does not produce folds that extend to the curved seal portion, and bag rupture due to film tearing does not occur.

[0081] In Comparative Example 2, where the weak seal portion for preventing inflow did not have a curved seal portion and was trapezoidal in shape, even though the B / W and A / B ratios of the weak seal portion for preventing inflow were the same as in Example 1, in 52 bags, approximately 6% of the total samples, folds and wrinkles extending toward the two corners of the weak seal portion for preventing inflow occurred and reached the bag, and in 2 bags, one of the films tore at the peeled portion after the weak seal portion for preventing inflow was peeled off, resulting in the bag rupturing. In addition, stringing due to cohesive failure occurred in 12 bags of samples. [Explanation of Symbols]

[0082] 1. Medical multi-chambered container 10 Container body 11 Film Pharmacy Rooms 12A and 12B 13 Weak sealing section for partitions 14 ports 15 Weak seal section for preventing inflow 15a Edge 15b Curved sealing section 15c First straight seal section 15d Second straight seal section 16 Concave sealing portion 17 Peripheral sealing portion 17A Side seal section 17B Upper seal section 17C Lower seal section 18 Suspension hole 19 Komuro

Claims

1. The container comprises a substantially rectangular container body having multiple drug chambers formed by sealing the periphery of overlapping films, and a drug discharge port attached to the periphery seal portion of the container body. The aforementioned film is a film whose main component is a polyethylene resin, The aforementioned multiple pharmacy rooms are separated by partitioning weak seal sections that allow adjacent pharmacy rooms to communicate with each other. The port is provided in the peripheral seal portion opposite to the partitioning weak seal portion in the drug chamber, which is surrounded by the partitioning weak seal portion and the peripheral seal portion. A medical multi-chamber container having a weak seal portion for temporarily preventing the inflow of a drug contained in the drug chamber into the port, wherein the drug chamber is provided with the port, In a plan view of the container body as seen from one planar side, the inflow-blocking weak seal portion includes a curved seal portion located in the central part, the edge opposite to the port being a convex arc toward the partitioning weak seal portion, and a first straight seal portion and a second straight seal portion, the edges of which extend linearly from both ends of the curved seal portion to the peripheral seal portions on both sides of the port. A medical multi-chambered container that satisfies the following conditions (1) to (4), where r (mm) is the radius of curvature of the arc of the edge of the curved seal portion, θ (°) is the central angle of the sector formed by the arc of the edge of the curved seal portion, A (mm) is the distance between the line connecting the intersection points of the edges of the first straight seal portion and the second straight seal portion and the peripheral seal portion and the position on the edge of the curved seal portion furthest from the line, B (mm) is the width dimension of the weak seal portion for preventing inflow, and W (mm) is the width dimension of the container body. 20 ≤ r ≤ 40 ... (1) θ>100°...(2) B / W≦0.26...(3) 0.40 ≤ A / B ≤ 0.50 ... (4)

2. The medical multi-chamber container according to claim 1, wherein the first straight sealing portion and the second straight sealing portion have a shape that tapers towards the tip.

3. The medical multi-chamber container according to claim 1, wherein when the contents are filled to a filling rate of 45% of the total maximum capacity of the multiple drug chambers, the partitioning weak seal portion is peeled off, and before the inflow-blocking weak seal portion is peeled off, the medical multi-chamber container is held so as to extend vertically with the port facing downwards, and the bulge C in the thickness direction of the container above the inflow-blocking weak seal portion is 10 cm or less.

Citation Information

Patent Citations

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