Bag-like container, medical multi-chamber container, mold and method for forming curved strip-shaped weak seal part
Abstract
Problem to be solved.To provide a curved band-shaped weak seal portion which does not cause unintended peeling due to an impact such as dropping and can be easily opened when necessary without using a protective member.
Solution.A medical multi-chamber container 1 is formed by sealing the peripheral edges of overlapping films 11 and 11 to each other, and partitions a plurality of drug chambers 12A and 12B and a plurality of drug chambers 12A and 12B so as to be able to communicate with each other. The weak seal for compartment 13 and the port 14 for discharging the drug provided in one of the drug chambers 12A and 12B, and the weak seal for compartment 13 are formed so as to project toward the side and surround the port 14. It has an inflow blocking weak seal portion 15 that temporarily blocks the inflow of the drug contained in the chambers 12A and 12B into the port 14, and an inflow blocking portion 15 is provided on at least one surface of the inflow blocking weak seal portion 15. A groove is formed in which the weak seal portion 15 extends in a continuous direction. [Selection diagram] Fig. 1

Term
8.6 yearsto projected expiry
Projected expiry 21 April 2035, counted from filing; an application has no term until it is granted.
- Priority and filed
- Published
- Today
- Projected expiry
7 claims: 2 independent, 5 dependent
- 1重なり合うフィルムの周縁同士をシールすることにより形成され、 物質を収容する室と、 前記室を区画するように設けられた曲線帯状弱シール部と、 を有し、 前記曲線帯状弱シール部の少なくとも一方の表面に、前記曲線帯状弱シール部が連続する方向に沿って延びる線状シール部が形成されていることを特徴とする袋状容器。
- 2前記室を複数有し、 前記複数の室を連通可能に区画する区画用弱シール部と、 前記室の1つに設けられたポートと、 を有し、 前記曲線帯状弱シール部は、前記区画用弱シール部側に向かって突出して前記ポートを取り囲むように形成され、前記室に収容された物質の前記ポートへの流入を一時的に阻止する流入阻止用弱シール部であることを特徴とする請求項1に記載の袋状容器。
- 3重なり合うフィルムの周縁同士をシールすることにより形成され、 複数の薬剤室と、 前記複数の薬剤室を連通可能に区画する区画用弱シール部と、 前記薬剤室の1つに設けられた薬剤排出用のポートと、 前記区画用弱シール部側に向かって突出して前記ポートを取り囲むように形成された曲線帯状弱シール部と、 を有する医療用複室容器であって、 前記曲線帯状弱シール部は、前記薬剤室に収容された薬剤の前記ポートへの流入を一時的に阻止する流入阻止用弱シール部であり、 前記流入阻止用弱シール部の少なくとも一方の表面に、前記流入阻止用弱シール部が連続する方向に沿って延びる線状シール部が形成されていることを特徴とする医療用複室容器。
- 4前記流入阻止用弱シール部の他方の表面に、前記流入阻止用弱シール部が連続する方向に沿って間隔を空けた複数の点状シール部が、前記線状シール部に対向するように形成されていることを特徴とする請求項3に記載の医療用複室容器。
- 5前記線状シール部は、前記流入阻止用弱シール部において、少なくとも前記区画用弱シール部側に突出した先端部に形成されていることを特徴とする請求項3または4に記載の医療用複室容器。
- 6請求項1から5のいずれか1項に記載の前記曲線帯状弱シール部を形成する金型であって、 押圧面に、前記曲線帯状弱シール部が連続する方向に沿って延びる突条が形成されていることを特徴とする金型。
- 7請求項1から5のいずれか1項に記載の前記曲線帯状弱シール部の形成方法であって、 押圧面に、前記曲線帯状弱シール部が連続する方向に沿って延びる突条が形成されている金型を加熱しつつ前記フィルムの表面に押圧し、前記突条により、前記曲線帯状弱シール部の表面に前記線状シール部を形成することを特徴とする曲線帯状弱シール部の形成方法。
Independent claims7
84 paragraphs, as filed
The present invention relates to a bag-shaped container, a medical multi-chamber container, a mold, and a method for forming a curved band-shaped weak seal portion.
In a multi-chamber bag-shaped container such as a medical multi-chamber container, powder and liquid or a plurality of different kinds of liquids are stored, respectively, so that the powder and the liquid or a plurality of kinds of liquids can be mixed at the time of use. There is something that I did. For example, in the medical field, as a medical multi-chamber container for accommodating a drug for infusion therapy, a different type of drug is used in each of a plurality of drug chambers made of a flexible film and partitioned by a partition wall provided in the container. Is used. As a combination of a plurality of drugs, for example, an amino acid and a glucose infusion solution, an antibiotic and a solution thereof, and the like, which may cause deterioration over time when mixed and stored. Each drug chamber of the medical multi-chamber 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 the drug chambers adjacent to each other is a weak seal portion having a lower seal strength than the seal portion along the outer peripheral shape of each drug chamber. As a result, in the partition wall portion, the two flexible films forming the medical multi-chamber container are sealed in a peelable state.
When performing infusion therapy using a medical multi-chamber container, an internal pressure is applied to the drug by pressing one chamber containing the liquid drug from the outside before use. Then, the two flexible films are peeled off from each other at the weakly sealed portion to destroy the partition wall, and the drug chambers adjacent to each other with the partition wall in between communicate with each other. As a result, the plurality of drugs contained in each drug room are aseptically mixed in the medical multi-chamber container. The mixed drug is discharged from the discharge port of the container via the needle and tube of the infusion set and administered to the patient.
In the case of infusion treatment using a medical multi-chamber container in which a plurality of drugs are mixed and used in this way, the unmixed drug is erroneously infused without destroying the partition wall of the medical multi-chamber container. It has been pointed out that there is a risk that it will end up.
Therefore, in order to prevent the drug before mixing from being administered and to improve the safety in use, a medical compound equipped with a weak seal portion for inflow prevention that obstructs communication between the drug chamber and the discharge port. The chamber container is disclosed (see, for example, Patent Document 1). The medical multi-chamber container described in Patent Document 1 is provided with two weakly sealed portions. The first weak seal portion is provided as a partition wall for partitioning the first and second drug chambers, and the partition weak seal portion is provided in a straight strip shape with a constant width so as to cross the container body. The second weak seal portion is a partition wall that prevents only the chemical solution in the first drug chamber before being mixed from flowing out from the discharge port, and the inflow prevention weak seal portion is constant so as to surround the discharge port. It is provided in a strip shape by combining straight lines and curves in width. The compartment weak seal portion faces the discharge port provided on the first drug chamber side and the inflow prevention weak seal portion that obstructs communication with the first drug chamber. When using this medical multi-chamber container, the liquid pressure in the second drug chamber is increased by pressing the second drug chamber from the outside, which does not have a weak seal portion for preventing inflow. Then, the weak seal portion for the compartment was peeled off, the first drug chamber and the second drug chamber communicated with each other, and the drug in the second drug chamber where the hydraulic pressure was increased was peeled off at the weak seal portion for the compartment. It flows into the first drug chamber through the section. As a result, the liquid pressure in the first drug chamber also increases, and the liquid pressure acts on the inflow blocking weak seal portion, and the inflow blocking weak seal portion is peeled off. This allows a mixture of the two drugs to be infused through the drain port. In this way, the communication operation between the first drug chamber and the second drug chamber and the peeling operation of the weak seal portion for preventing inflow can be performed by a single operation of pressing one of the drug chambers. ..
By the way, if the multi-chamber container as described above is accidentally dropped during transportation, for example, the pressure of the drug contained in the first drug chamber or the second drug chamber increases due to the impact at the time of dropping, and the compartment is divided. Peeling may occur at the weak seal portion, and the first drug chamber and the second drug chamber may communicate with each other. Therefore, as described in Patent Document 2, the multi-chamber container is stored in a packing box in a state of being folded by a compartment weak seal portion which is a first weak seal portion for partitioning a plurality of chambers. Will be packed. By folding the multi-chamber container at the compartment weak seal portion, it is possible to prevent the weak seal portion for the compartment from being peeled off due to the impact of dropping the packing box or the like, resulting in unintended opening.
However, as in the configuration disclosed in Patent Document 2, the method of folding the multi-chamber container protects the weak seal portion for preventing inflow, which is the second weak seal portion having a partially curved band shape. It is not possible to rule out the possibility that the pressure of the drug in the second drug chamber will increase due to an impact such as dropping, and peeling will occur in the weak seal portion for preventing inflow. Therefore, Patent Document 3 discloses a configuration in which a protective member for protecting the inflow blocking weak seal portion is provided in the packaging box in order to prevent unintentional opening of the inflow blocking weak seal portion.
<p num="0008"><patcit num="1"><text>Japanese Unexamined Patent Publication No. 2006-43061</text></patcit><patcit num="2"><text>Japanese Unexamined Patent Publication No. 2004-149124</text></patcit><patcit num="3"><text>Utility Model Registration No. 3160045</text></patcit></p>
<p num="0009"> However, in the configuration as disclosed in Patent Document 3, the use of the protective member causes an increase in the cost of the packaging material and also increases the amount of waste. Therefore, the present invention has been made in view of the above circumstances, and is a curved strip-shaped weak seal portion that does not cause unintended peeling due to an impact such as dropping and can be easily opened when necessary without using a protective member. Provided are a bag-shaped container provided with the above, a medical multi-chamber container provided with a curved band-shaped weak seal portion for preventing inflow, a mold and a method for forming the curved band-shaped weak seal portion.</p>
<p num="0010"> In order to solve the above problems, the bag-shaped container of the present invention is formed by sealing the peripheral edges of the overlapping films, and is provided to partition the chamber from the chamber containing the substance and the curved strip-shaped weak seal. A linear seal portion is formed on at least one surface of the curved strip-shaped weak seal portion. The curved strip-shaped weak seal portion extends along a continuous direction.</p><p num="0011"> According to the present invention, when a force is applied to the bag-shaped container from the outside and the pressure of the article housed in the chamber is increased, the pressure is in the direction in which the curved band-shaped weak sealing portion is continuous with respect to the curved band-shaped weak sealing portion. Acts in the direction of intersection with respect to. Since the curved band-shaped weak seal portion is formed with a linear seal portion extending along the continuous direction of the curved band-shaped weak seal portion, it is possible to prevent the applied pressure from concentrating and the curved band-shaped weak seal portion is not prepared. It can be suppressed from peeling off.</p><p num="0012"> Further, the curved band-shaped weak seal portion has a plurality of the chambers, a partition weak seal portion for partitioning the plurality of chambers so as to be communicable, and a port provided in one of the chambers. Even if it is an inflow prevention weak seal portion that is formed so as to project toward the partition weak seal portion side and surround the port, and temporarily blocks the inflow of substances contained in the chamber into the port. Good.</p><p num="0013"> According to the present invention, when an external force is applied to the bag-shaped container and the pressure of the article housed in the chamber is increased, the pressure is applied to the inflow blocking weak seal portion and the inflow blocking weak seal portion continuously. It acts in the direction that intersects with the direction in which it does. Since the inflow blocking weak seal portion is formed with a linear sealing portion in which the inflow blocking weak sealing portion extends in a continuous direction, it prevents the applied pressure from concentrating and prevents the inflow blocking weak sealing portion. Can be prevented from being inadvertently peeled off.</p><p num="0014"> Further, the medical multi-chamber container of the present invention is formed by sealing the peripheral edges of the overlapping films, and includes a plurality of drug chambers, a weak seal portion for partition that partitions the plurality of drug chambers so as to be communicable, and the above. A medical compound chamber having a drug discharge port provided in one of the drug chambers and a curved band-shaped weak seal portion formed so as to project toward the compartment weak seal portion side and surround the port. The curved strip-shaped weak seal portion of the container is an inflow prevention weak seal portion that temporarily blocks the inflow of the drug contained in the drug chamber into the port, and is a weak seal portion for inflow prevention. It is characterized in that a linear seal portion extending along a continuous direction is formed on at least one surface of the weak seal portion for preventing inflow.</p><p num="0015"> According to the present invention, when an external force is applied to the medical multi-chamber container and the pressure of the drug contained in the drug chamber increases, the pressure is applied to the inflow blocking weak seal portion with respect to the inflow blocking weak seal. It acts in the direction in which the parts intersect with respect to the continuous direction. On the other hand, the weak seal portion for inflow prevention is formed with a linear seal portion extending along the continuous direction of the weak seal portion for inflow prevention, so that the applied pressure is prevented from concentrating and the inflow is prevented. It is possible to prevent the weak seal portion from being inadvertently peeled off.</p><p num="0016"> Further, on the other surface of the inflow blocking weak sealing portion, a plurality of point-shaped sealing portions spaced apart along a direction in which the inflow blocking weak sealing portion is continuous face the linear sealing portion. It may be formed in. By providing the point-shaped seal portion facing the linear seal portion in this way, unintended peeling does not occur due to an impact such as dropping, and there is little variation in peel strength that can be easily opened when necessary. , A weak seal portion having stable peel strength can be obtained.</p><p num="0017"> Further, the linear seal portion may be formed at least at the tip portion of the inflow blocking weak seal portion that protrudes toward the section weak seal portion. The pressure of the drug contained in the drug chamber concentrates on the tip of the weak seal for blocking inflow, which protrudes toward the weak seal for partitioning. Therefore, by providing the linear seal portion at the tip portion, it is possible to effectively prevent the weak seal portion for preventing inflow from being inadvertently peeled off.</p><p num="0018"> Further, the mold of the present invention is a mold for forming the curved strip-shaped weak seal portion as described above, and a ridge extending along a direction in which the curved strip-shaped weak seal portion extends is formed on the pressing surface. It is characterized by being done. Further, the method for forming the curved band-shaped weak seal portion of the present invention is the method for forming the curved band-shaped weak seal portion as described above, and the curved band-shaped weak seal portion extends along a continuous direction on the pressing surface. It is characterized in that the mold on which the ridges are formed is pressed against the surface of the film while being heated, and the linear seal portion is formed on the surface of the curved band-shaped weak seal portion by the ridges.</p><p num="0019"> By pressing such a mold against the surface of the film while heating it, a linear seal portion can be formed on the surface of the curved band-shaped weak seal portion by the ridges.</p>
<p num="0020"> According to the present invention, it is possible to prevent the curved strip-shaped weak seal portion from being inadvertently peeled off. As a result, even if a protective member is not used as in the prior art, the curved band-shaped weak seal portion does not unintentionally peel off due to an impact such as dropping, and the curved band-shaped weak seal portion can be easily opened when necessary.</p>
<figref num="1">It is a top view which shows the structure of the medical multi-chamber container in one Embodiment of this invention.</figref><figref num="2">It is an enlarged plan view of a part area of the weak seal part for blocking inflow.</figref><figref num="3">It is a perspective sectional view along the AA line of FIG.</figref><figref num="4">It is a perspective sectional view along the BB line of FIG.</figref><figref num="5">It is sectional drawing along the CC line of FIG.</figref><figref num="6">It is a top view which shows the pressing surface of the mold for forming a groove.</figref><figref num="7">It is sectional drawing which follows the DD line of FIG.</figref><figref num="8">It is a top view which shows the mold surface of the mold for forming a recess.</figref><figref num="9">It is a top view which shows the structure of the medical multi-chamber container which concerns on other embodiment.</figref><figref num="10">It is a top view which shows the mold surface of one mold used for the seal of the comparative example.</figref><figref num="11">It is a top view which shows the mold surface of the other mold used for the seal of the comparative example.</figref><figref num="12">It is a schematic diagram which shows the accommodation state of the medical multi-chamber container at the time of performing a drop test.</figref>
Next, an embodiment of the present invention will be described with reference to the drawings. FIG. 1 is a plan view showing the configuration of a medical multi-chamber container according to an embodiment of the present invention. As shown in FIG. 1, the medical multi-chamber container 1, which is a kind of bag-shaped container, has a plurality of (two in this embodiment) drug chambers (corresponding to the chamber in the claim) 12 provided side by side. It has (12A, 12B) and port 14. Here, in the following description, in the medical multi-chamber container 1, the direction in which the two drug chambers 12A and 12B are lined up is the vertical direction Y, and the direction orthogonal to the vertical direction Y on the surface of the film 11 is the width direction X. ..
The medical multi-chamber container 1 is formed in a substantially rectangular shape in a plan view, and two films 11 are overlapped with each other, and a peripheral seal portion 17, a concave seal portion 16, a weak seal portion 13 for division, and the like, It is formed by sealing with a weak seal portion 15 for preventing inflow, which is a curved strip-shaped weak seal portion.
The drug chambers 12A and 12B are formed by partitioning the space surrounded by the peripheral seal portion 17 sealed along the peripheral edge of the two films 11 into two in the vertical direction Y by the weak seal portion 13 for partitioning. ing.
The peripheral seal portions 17 are formed at both ends of the medical double chamber container 1 in the width direction X, and are formed at both ends of the side seal portions 17A and 17A extending in the vertical direction Y and the vertical direction Y of the medical double chamber container 1. It is provided with an upper seal portion 17B and a lower seal portion 17C extending in the width direction X. The upper seal portion 17B and the lower seal portion 17C are each formed to have a wider seal width than the side seal portion 17A.
In the middle portion of the side seal portions 17A and 17A in the vertical direction Y, a concave seal portion 16 recessed in a substantially U shape toward the central portion in the width direction X, that is, the medical multi-chamber container 1 is provided. It is formed. In each concave seal portion 16, the tip portion 16a projecting toward the most central portion in the width direction X is formed so as to overlap the end portion of the partition weak seal portion 13 in the width direction X.
In the concave seal portion 16, the dent height H indicating the degree of denting toward the inside of the medical multi-chamber container 1 in the width direction X is a total of 2H of the dent heights of the pair of concave seal portions 16 and 16 for medical use. It is preferably 10 to 50%, preferably 15 to 45% of the total width W (length dimension in the width direction X) of the multi-chamber container 1. If the total 2H of the dent height is 10% or more, it is difficult for an unopened portion to remain at the longitudinal end of the compartment weak seal portion 13, and even if the medical multi-chamber container 1 falls, the unopened portion remains. Bag breakage from near the edge is less likely to occur. Further, if the total 2H of the dent height is 50% or less, the capacity of the contents of the drug chamber 12 can be sufficiently maintained.
The concave seal portion 16 preferably has a radius of curvature of the tip portion 16a protruding inward in the width direction X of 15 mm to 30 mm. If the radius of curvature is 15 mm or more, bag breakage is less likely to occur even if the bag is dropped. Further, if the radius of curvature is 30 mm or less, the capacity of the contents of the drug chamber 12 can be sufficiently maintained. Further, the concave seal portions 16 and 16 shown in FIG. 1 are symmetrical in the width direction X in the present embodiment, but the present invention is not limited to this and may be asymmetric.
The upper seal portion 17B is formed with portions (first unbonded portion 11a) in which the overlapping films 11 and 11 are not adhered to each other on the left and right sides in the width direction X. Further, in the upper seal portion 17B, a suspension hole 18 is formed between the first unbonded portions 11a and 11a on both the left and right sides in the width direction X and at the center of the width direction X. The suspension hole 18 is formed through the two films 11 and 11. The suspension hole 18 is a hole used when the medical multi-chamber container 1 is suspended and used.
The lower seal portion 17C is formed with a portion (second non-adhesive portion 11b) in which the overlapping films 11 and 11 are not adhered to each other on one side in the left-right direction of the width direction X. Further, on the other side of the width direction X in the left-right direction, a planned filling port portion to be used as a filling port for the drug chamber 12B protruding outward from the outer shape of the approximately rectangular medical double chamber container 1 is formed. Has been done. The planned filling port may be provided on any side of the rectangle, or a plurality of planned filling ports may be provided. In FIG. 1, the filling port to the drug chamber 12A is omitted.
The port 14 is provided in one of the drug chambers 12 (here, the drug chamber 12B) on the side opposite to the compartment weak seal portion 13. The port 14 is provided at the center of the lower seal portion 17C in the width direction X. The port 14 is sandwiched and fixed between the two films 11 at the lower seal portion 17C. This port 14 is used for injecting and discharging a drug, and is a passage that enables access from the outside of the container to the inside of the container. The port 14 is provided so that the central axis of the passage formed by the port 14 coincides with the vertical direction in a state where the medical multi-chamber container 1 is suspended by the suspension hole 18. The port 14 is made of an injection molded product of thermoplastic resin, and the opening is sealed with an elastic body such as rubber (not shown) that can be pierced so that a needle can be inserted. A tube may be used instead of the port 14.
The partition weak seal portion 13 is formed in a straight strip shape along the width direction X so as to connect the tip portions 16a, 16a of the pair of left and right concave seal portions 16, 16. The compartment weak seal portion 13 is provided at a position facing the inflow prevention weak seal portion 15 provided in the drug chamber 12B. The width dimension D1 of the section weak seal portion 13 is not particularly limited, but is determined to be, for example, about 5 mm to 20 mm. It is also preferable that the section weak seal portion 13 is long until it penetrates the tip portions 16a and 16a of the pair of left and right concave seal portions 16 and 16 and reaches the side seal portions 17A and 17A. The reason for this is that in the weak seal mold having a linear band-shaped heating portion for manufacturing the compartment weak seal portion 13, the central portion of the linear band-shaped heating portion in the long direction is stably maintained at a constant temperature. However, since the same end is the end of the mold, it is difficult to maintain a stable constant temperature due to external influences, and the peeling strength may vary widely due to this, but the seal is weak. If the die reaches or is longer than the side seals 17A and 17A of the weak seal 13 for the compartment, the weak seal 13 for the compartment uses only the central portion in the long direction that is stable at a constant temperature. This is because it is possible to manufacture. As a result, the weak seal portion 13 for a section can be formed so that unintended peeling does not occur due to an impact such as dropping and the strength is exhibited so that the seal can be easily opened when necessary.
In the section weak seal portion 13, the two overlapping films 11 and 11 are peelably sealed to each other, and the two drug chambers 12A and 12B are isolated so as to be able to communicate with each other. The compartment weak seal portion 13 isolates the drug chambers 12A and 12B in a state before use, and blocks communication between the two. The compartment weak seal portion 13 can be peeled off by pressing the adjacent drug chambers 12A or 12B from the outside and increasing the internal pressure thereof during use. By peeling off the weak seal portion 13 for partitioning, the drug chambers 12A and 12B communicate with each other.
For the weak seal portion 13 for compartments, 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 further 1.5 to 5 N / 10 mm width. It is more preferable to do so. Further, when the drug chamber 12A or the drug chamber 12B is pressed from the outside and the weak seal portion 13 for partitioning is peeled off and communicates with each other, the communication strength is preferably 200N to 800N, more preferably 300N to 700N. .. Within such a range, there is an advantage that an excessive force is not required at the time of use, and the weak seal portion 13 for partitioning can be peeled off without destroying the medical multi-chamber container 1.
Further, the peel strength of the section weak seal portion 13 may be constant in the width direction X of the medical multi-chamber container 1, but it is also preferable to change it in the width direction X of the medical multi-chamber container 1. is there. For example, it is also preferable to increase the peel strength of the central portion 13a in the width direction X of the section weak seal portion 13 and lower the peel strength of both end portions 13b and 13c in the width direction X than that of the central portion 13a. Specifically, it is preferable that the peel strength of both ends 13b and 13c is 20 to 80% of the peel strength of the central portion 13a. By doing so, it is possible to minimize or eliminate the remaining unpeeled portions of both ends 13b and 13c after communication. When the unpeeled portion remains, the end portion of the remaining weak seal portion 13 for the partition becomes a stress concentration portion when the medical double chamber container 1 is dropped, and the medical double chamber container 1 is likely to break. If the peel strength of both ends 13b and 13c in the width direction X is lowered in the weak seal portion 13 for partitioning, it becomes difficult for the unpeeled portion to remain, and even if it remains, it is higher than the peel strength of the central portion 13a in the width direction X. Of the weak seal portions 13 for compartments that have low peel strength and can be peeled off, the weak seal portion is easier to peel off. As a result, it is possible to prevent the weak seal portion 13 for partitioning from becoming a stress concentration portion that leads to bag breakage as much as possible. As a result, it is possible to prevent the medical multi-chamber container 1 from breaking.
In order to increase the peeling strength of the central portion 13a in the width direction X and decrease the peeling strength of both ends 13b and 13c in the width direction X in the compartment weak seal portion 13, heat during manufacturing of the compartment weak seal portion 13 is required. The method of setting the sealing temperature so that the central portion 13a is high and the both ends 13b and 13c are low, and the shape of the sealing mold at the time of manufacturing the sealing portion increases the sealing pressure of the central portion 13a and seals the both ends 13b and 13c. Examples include a method of adjusting the pressure to a low level, a method of increasing the amount of heat received by the central portion 13a per unit time by the seal pattern of the seal mold, and a method of decreasing the amount of heat received by both ends 13b and 13c per unit time.
When the partition weak seal portion 13 is peeled off by pressing the drug chamber 12A from the outside to increase the internal pressure of the drug chamber 12A, the inflow blocking weak seal portion 15 should be easily peeled off continuously. In this case, it is preferable that the peel strength of the central portion 13a of the section weak seal portion 13 is lower than the peel strength of both end portions 13b and 13c. By doing so, when the central portion 13a of the section weak seal portion 13 is peeled off, the drug in the pharmaceutical chamber 12A is concentrated on the central portion 13a and is concentrated in the central portion 13a from one side of the vertical direction Y of the pharmaceutical chamber 12B. It becomes easy to flow into the central part of the width direction X of 12B. As will be described later, the pressure of the drug flowing into the drug chamber 12B acts on the weak seal portion 15 for preventing inflow located at the center of the width direction X on the other side of the vertical direction Y of the drug chamber 12B, so that the drug flows in. The blocking weak seal portion 15 can be easily peeled off.
In this way, in order to reduce the peeling strength of the central portion 13a in the width direction X and increase the peeling strength of both end portions 13b and 13c in the width direction X in the compartment weak seal portion 13, the compartment weak seal portion 13 The method of setting the heat seal temperature at the time of manufacturing so that the central part 13a is low and the both ends 13b and 13c are high, and the shape of the seal mold at the time of manufacturing the seal part makes the sealing pressure of the central part 13a low and both ends 13b , The method of adjusting the seal pressure of 13c to a high value, the method of reducing the amount of heat received by the central portion 13a per unit time by the seal pattern of the seal mold, and the method of increasing the amount of heat received by both ends 13b and 13c per unit time, etc. Can be mentioned.
The inflow blocking weak seal portion 15 is formed in the drug chamber 12B provided with the port 14 so as to surround the port 14. The inflow blocking weak seal portion 15 temporarily blocks the inflow of the drug into the port 14 to prevent the pre-mixed drug from being administered to the patient. The inflow blocking weak seal portion 15 includes straight seal portions 15a and 15a and a curved seal portion (corresponding to the tip portion of the claim) 15b.
The straight seal portions 15a and 15a are formed symmetrically with respect to the center in the width direction X. Each straight seal portion 15a is formed in the lower seal portion 17C so as to extend diagonally linearly from a position separated from the port 14 in the width direction X so as to gradually approach the center side in the width direction X upward. Has been done.
The curved seal portion 15b is continuously formed between the upper ends of the straight seal portions 15a and 15a. The curved seal portion 15b is formed so as to be convex upward. The radius of curvature of the curved seal portion 15b is preferably about 20 mm to 40 mm, and more preferably about 25 mm to 35 mm. As the radius of curvature of the curved seal portion 15b becomes smaller, the weak seal portion 15 for preventing inflow tends to be easily peeled off, and tends to be easily peeled off when the container is transferred. Further, as the radius of curvature of the curved seal portion 15b becomes larger, the area surrounded by the weak seal portion 15 for preventing inflow and the lower seal portion 17C becomes larger, and the amount of the chemical solution that can be filled in the drug chamber 12B decreases.
The shape of the inflow blocking weak seal portion 15 is not limited to the above-mentioned shape, and may be any curved shape such as a semicircular shape, a semi-elliptical shape, or a partial shape of a polygon. In the inflow blocking weak seal portion 15, the number of portions that are convex upward may be one or a plurality. As shown in FIG. 1, when there is one convex curved seal portion 15b, the curved seal portion 15b is located at the position closest to the section weak seal portion 13 in the inflow prevention weak seal portion 15. To do so. The convex curved seal portion 15b is a portion where the weak seal portion 13 for partitioning is peeled off and the chemical liquid flowing into the drug chamber 12A from the drug chamber 12A first reaches and stress is concentrated. It is preferable because it facilitates the start of peeling of 15. Further, it is preferable that the shape of the weak seal portion 15 for preventing inflow is symmetrical with the axis in the long direction of the port as the target axis.
The seal width dimensions of the straight seal portion 15a and the curved seal portion 15b constituting the strip-shaped weak seal portion 15 for preventing inflow are not particularly limited, but are preferably about 5 mm to 20 mm, for example. Further, the straight seal portion 15a and the curved seal portion 15b all have the same constant width, and for example, the portion of the weak seal portion 15 for preventing inflow near the lower seal portion 17C is partially narrowed. For example, a portion that is harder to peel off than the top may be made easier to peel off.
FIG. 2 is an enlarged plan view of a partial region R of the inflow blocking weak seal portion surrounded by a broken line in FIG. FIG. 2 shows a pattern on one outer surface shown by a solid line and a pattern on the other outer surface shown by a broken line. FIG. 3 is a perspective sectional view taken along the line AA of FIG. FIG. 4 is a perspective sectional view taken along the line BB of FIG. FIG. 5 is a cross-sectional view taken along the CC line of FIG. As shown in FIGS. 2 to 5, the inflow blocking weak sealing portion 15 has an inflow blocking weak sealing portion 15 continuous with the outer surface 11f of one of the two films 11 and 11 in the inflow blocking weak sealing portion 15. A plurality of grooves (corresponding to the "linear seal portion" of the claim) 21 are formed along the direction. These plurality of grooves 21 are formed at intervals in the width direction of the inflow blocking weak seal portion 15. Each groove 21 has a groove bottom surface 21a having a predetermined width. Further, each groove 21 is formed so that the groove width dimension gradually decreases from the outer surface 11f side of the film 11 toward the groove bottom surface 21a.
Further, as shown in FIGS. 2, 3 and 5, the weak seal portion 15 for preventing inflow has a plurality of recesses (claims) in the outer surface 11 g of the other film 11 of the two films 11 and 11. Corresponds to the "dotted seal" in the section.) 22 is formed. These recesses 22 are provided in a plurality of rows at intervals in the width direction of the inflow blocking weak seal portion 15. In each row, a plurality of recesses 22 are provided at intervals along the direction in which the inflow blocking weak seal portions 15 are continuous. Further, the recesses 22 in each row are formed at positions facing the grooves 21. Each recess 22 has a recess bottom surface 22a having a predetermined width. Further, each recess 22 is formed so that the cross-sectional area of the recess along the surface parallel to the recess bottom 22a gradually decreases from the outer surface 11g side of the film 11 toward the recess bottom 22a. Further, in addition to the recesses 22 in each row being formed at positions facing the grooves 21, as can be seen from FIGS. 2 and 3, the groove bottom surface 21a and the recess bottom surface 22a are also located at positions facing each other. It is preferably formed. Since the bottom surface of the groove 21a and the bottom surface of the recess 22a face each other, unintended peeling does not occur due to an impact such as dropping, and the inflow has stable peel strength with little variation in peel strength that can be easily opened when necessary. It becomes easy to use the weak seal portion 15 for blocking.
FIG. 6 is a plan view showing a pressing surface of a mold for forming a groove. FIG. 7 is a cross-sectional view taken along the DD line of FIG. FIG. 8 is a plan view showing a mold surface of a mold for forming a recess. In the weak seal portion 15 for preventing inflow as described above, the mold 30A (see FIGS. 6 and 7) is arranged on one side of the two films 11 and 11 which are overlapped with each other, and the mold is placed on the other side. It is formed by arranging 30B (see FIG. 8) and pressing these molds 30A and 30B while heating them.
As shown in FIGS. 6 and 7, in the mold 30A, continuous ridges 31 along the contour of the inflow blocking weak seal portion 15 to be formed are spaced apart in the width direction on the pressing surface 30f. Multiple lines are formed. Each ridge 31 has a trapezoidal cross section, and a groove 21 is formed by heating and pressing the pressing surface 30f of the mold 30A against the outer surface 11f of the film 11. Here, the ridge 31 is formed with a width of, for example, 1 mm, the width of the pressing surface 30f, which is the top surface of the ridge 31, is formed with a width of 0.4 mm, and further, the top surfaces of the ridges 31, 31 adjacent to each other are formed. The distance between the edge and the edge of the top surface adjacent to each other is set to, for example, 0.6 mm, and the bases of the ridges 31 are provided in close contact with each other. In other words, the mold 30A has an inverted triangular groove with a width of 0.6 mm that is continuous along the contour of the inflow blocking weak seal portion 15 to be formed on the mold surface, and the deepest portion of the groove is 1 mm. A plurality of lines are formed in the width direction so as to be spaced apart.
As shown in FIG. 8, in the mold 30B, a groove 32 having an inverted triangular cross section continuous along the contour of the inflow blocking weak seal portion 15 (see FIG. 1) to be formed has a width on the mold surface 30 g. A plurality of lines are formed at intervals in the direction. Further, on the mold surface 30g, a plurality of grooves 33 having inverted triangular cross sections extending in a direction intersecting the grooves 32 are formed in parallel with each other. The grooves 32 and 33 form a plurality of approximately square pyramid protrusions 34 spaced apart from each other. Here, the groove 32 is formed with a width of, for example, 0.6 mm, and the distance between the deepest portions of the grooves 32, 32 adjacent to each other is set to, for example, 1 mm. Further, the groove 33 intersecting the groove 32 is formed with a width of, for example, 0.6 mm, and the distance between the deepest portions of the grooves 32, 32 adjacent to each other is set to, for example, 1 mm. The top surface of each protrusion 34 is formed with an external dimension of, for example, about 0.4 mm square, and the portion forming the curved seal portion at the tip portion is approximately square, and the portion forming the straight seal portion other than the tip portion. Then it is a parallelogram. In other words, in the mold 30B, a square or parallelogram-like quadrangular pyramid with a bottom surface of about 1 mm on a side and a top surface of about 0.4 mm on a side is formed in close contact with the bottom surface.
Here, in the mold for manufacturing the inflow blocking weak seal portion 15, the outer shape of the ridge 31 and the protrusion 34 located on the peripheral edge portion on the drug chamber 12B side is parallel to the contour shape of the inflow blocking weak seal portion 15. However, it may be formed so as to be inclined within a range from parallel to, for example, about 10 °.
The inflow blocking weak seal portion 15 is sandwiched between the molds 30A and 30B as described above in a state where the two films 11 and 11 are overlapped with each other. For example, 120 ° C to 150 ° C and a pressure of 0.05 to It is preferably formed by heating and pressing at 2 MPa and a time of 0.5 to 10 sec. More specifically, for example, when the films 11 and 11 are polyethylene resins, the weak seal portion 15 for preventing inflow is pressed by heating with the dies 30A and 30B at 120 ° C to 135 ° C and a pressure of 0.1 to 1 MPa. It is preferable to form.
In addition, the peel strength when the weak seal portion 15 for inflow prevention is peeled off by the hydraulic pressure of the drug in the drug chamber 12B or the drug in the drug chambers 12A and 12B mixed with each other during use is JIS K6854-3. The T-shaped peel strength measured at a tensile speed of 300 mm / min in accordance with the above is preferably 4 to 20 N / 10 mm width, and more preferably 7 to 12 N / 10 mm width. Further, it is preferable that the peel strength of the weak seal portion 15 for blocking inflow is higher than the peel strength of the weak seal portion 13 for partitioning. Further, the peel strength of the section weak seal portion 13 and the inflow prevention weak seal portion 15 is set lower than the peel strength of the peripheral seal portion 17.
By doing so, when the drug chamber 12B provided with the port 14 is pressed from the outside, the weak seal portion 13 for partitioning does not peel off after the weak seal portion 15 for inflow prevention, and the weak seal portion 13 for inflow prevention is weak. Only the seal portion 15 is peeled off and the unmixed drug does not flow out from the port 14. In this way, the inflow blocking weak seal portion 15 has a function of temporarily blocking the inflow of the unmixed drug into the port 14. Further, when the inflow blocking weak seal portion 15 is peeled off and communicates by pressing the drug chamber 12B from the outside, the communication strength is 500N to 2000N, preferably 600N to 1500N. 15 can be easily opened.
In this way, when the linear groove 21 and the dotted recess 22 are formed on the outer surfaces 11f and 11g of the films 11 and 11 by the ridges 31 and the protrusions 34, the weak seal portion 15 for preventing inflow is formed. Compared with the case where the films 11 and 11 are sealed in a planar shape, the films 11 and 11 can be pressed with a higher pressure in a limited area and can be reliably sealed. In addition, molds 30A and 30B are manufactured so that the top surface of the ridge 31 and the top surface of the protrusion 34 can face each other, and the top surface and the protrusion of the protrusion 31 are manufactured using these molds 30A and 30B. It is preferable to seal the films 11 and 11 so as to face the top surface of 34. As a result, it is easy to provide a weak seal portion 15 for preventing inflow, which does not cause unintended peeling due to an impact such as dropping, has little variation in peel strength that can be easily opened when necessary, and has stable peel strength. It becomes.
The region where the linear grooves 21 and the dotted recesses 22 are formed on the outer surfaces 11f and 11g of the films 11 and 11 by the ridges 31 and the protrusions 34 as described above is the weak seal portion 15 for preventing inflow. The entire area, that is, the entire area of the straight seal portion 15a and the curved seal portion 15b may be used, but the present invention is not limited to this. At least, at the top of the curved sealing portion 15b that is convex toward the section weak sealing portion 13 side in the inflow blocking weak sealing portion 15, a linear groove 21 and a point-shaped recess 22 are formed to form the films 11, 11 May be sealed. Further, the films 11 and 11 may be sealed by forming a linear groove 21 and a point-shaped recess 22 only on the drug chamber 12B side in the width direction of the curved sealing portion 15b. More specifically, although it depends on the filling amount of the chemical solution, it may be formed and sealed on the drug chamber 12B side in the width direction of the curved sealing portion 15b so as to be about 1/3 of the width of the curved sealing portion 15b . That is, the straight seal portion 15a, which is harder to peel off by impact than the curved seal portion 15b, is not limited to the seal structure composed of the groove 21 and the recess 22, and may have another seal structure such as sealing in a planar shape. Further, the linear grooves 21 and the recesses 22 are provided at equal intervals in the width direction of the curved seal portion 15b, but may be intervals other than the equal intervals. Further, the recesses 22 are also provided at equal intervals with intervals in the continuous direction of the weak seal portions 15 for preventing inflow, but the intervals may be other than the equal intervals. Further, the inflow blocking weak seal portion 15 may be formed by combining a mold 30A having a ridge 31 or a mold 30B having a protrusion 34 and a flat mold (not shown). Further, the surface of the flat mold may be covered with, for example, a glass fiber reinforced fluororesin film.
In the space between the weak seal portion 15 for preventing inflow and the port 14, there is a small amount of sanitary saline or distilled water, for example, 0.01 mL to 1 mL, which can sterilize the space when the temperature is high. It is preferable to have. Further, a slit-shaped unsealed portion that allows an amount of liquid that can be sterilized to flow in from the drug chamber 12 is used as a weak seal portion 15 for preventing inflow within a range that does not contradict the gist of the present invention and does not affect the impact strength of the bag. It may be provided.
The materials of the film 11 and the port 14 constituting the medical multi-chamber container 1 of the present embodiment are each made of a thermoplastic resin. The thermoplastic resin is not particularly limited as long as it is used in the medical field, and can be used without particular limitation. Vinyl chloride, ethylene vinyl acetate copolymer, polyolefin, polyamide, polyester, polyether sulfone, cyclic polyolefin, cyclic polyolefin Examples thereof include copolymers, ethylene-based elastomers, styrene-based elastomers, and mixtures of these resins. In addition, these thermoplastic resins are partially crosslinked for the purpose of improving heat resistance, or are mixed with low melting point components such as ultra-low density polyethylene, ethylene-based elastomer, and styrene-based elastomer in order to actively block them. You may.
Among these thermoplastic resins, polyolefin is preferable because it is inexpensive and has excellent transparency and flexibility. Examples of the polyolefin include polyethylene resins such as high-density polyethylene, low-density polyethylene, and linear low-density polyethylene, olefin-based elastomers such as ethylene-butadiene random copolymers, polypropylene, ethylene, or propylene composed of α-olefin and propylene. Examples thereof include a polypropylene block copolymer resin containing a random copolymer and an ethylene-propylene copolymer elastomer. Further, among these polyolefin resins, polyethylene-based resins are preferable because they do not contain additives and have excellent hygiene.
The film 11 constituting the medical multi-chamber container 1 may be a single-layer film made of one type of film or a multilayer film in which a plurality of types of films are laminated. In the case of a single-layer film, since it is excellent in transparency and flexibility, linear low-density polyethylene, ethylene propylene random copolymer, ethylene propylene block copolymer, a mixture of polypropylene resin and styrene elastomer, etc. Film is preferred. When the film 11 is a multilayer film, the film used for the above-mentioned single-layer film is preferably used as the multilayer film, and the multilayer film having the highest thickness ratio as the main layer is preferable. Further, this main layer is used on the inner layer side of the medical multi-chamber container 1 and is provided with an outer layer having a higher softening temperature and melting point and higher heat resistance than the inner layer made of polyamide, polyester, polyether sulfone, etc. It may be made into a film. This is preferable because the film 11 can be heated and melted to shorten the time required to manufacture the medical multi-chamber container 1 and the productivity is increased. The inner layer of the film 11 and the outer layer thereof may be adhered with an adhesive. Further, in the inner layer of the film 11, an inner layer surface layer of 10% or less of the total thickness of the film 11 is provided on the side that becomes the liquid contact surface in the drug chambers 12A and 12B in order to improve the properties of the inner layer surface. It is also preferable. Further, the film 11 may be a multilayer film having a heat-resistant outer layer and the inner layer as the main layer, and the outer layer may be 10% or less and the inner layer may be 70% or more with respect to the total thickness of the film 11. preferable.
These films 11 are manufactured by a manufacturing method such as T-die molding, water-cooled or air-cooled inflation molding, laminate molding, and multi-layer coextrusion molding. From the viewpoint of transparency and hygiene, the film 11 produced by water-cooled inflation molding is preferable. The thickness of the film 11 is 5 to 1000 μm, preferably about 50 to 500 μm.
Here, the method for manufacturing the medical multi-chamber container 1 described above will be described. The formation of the weak seal portion 15 for preventing inflow is as described above. For the other parts, the laminated films 11 are sealed in the desired shape to prepare a medical multi-chamber container 1. As a sealing method, a heat sealing method or an impulse sealing method in which pressure is applied to the heating plate to press the film 11 can be adopted. A thermal mold can be used to seal the port 14 and the film 11. When the capacity of the medical multi-chamber container 1 is about 100 mL to 5 L, the seal width D2 of the concave seal portion 16 and the side seal portion 17A is in the range of 3 mm to 15 mm, preferably 4 mm to 10 mm. is there. Examples of the combination of drugs include a combination of an amino acid infusion solution and a glucose infusion solution, an antibiotic and a solution thereof.
Next, the operation of the medical multi-chamber container 1 of the present embodiment configured as described above will be described with reference to the drawings.
In order to dispense the mixed drug from the port 14 using the medical multi-chamber container 1 of the present embodiment shown in FIG. 1 and administer it to the patient, first, the upper side having no weak seal portion 15 for inflow prevention is not provided. Press the drug chamber 12A from the outside. Then, the internal pressure of the drug chamber 12A increases, and the section weak seal portion 13 peels off. As a result, the drug flows from the peeled section weak seal portion 13 into the lower drug chamber 12B having the inflow prevention weak seal portion 15. Due to the inflow of the drug, the drug in the drug chamber 12B collides with the weak seal portion 15 for preventing inflow facing the weak seal portion 13 for partitioning, and the internal pressure of the drug chamber 12B also rises to prevent the weak seal portion 15 for preventing inflow. Peel off. As a result, the drugs in the two drug chambers 12A and 12B are mixed with each other, and the mixed drug can be administered by intravenous drip from port 14. Therefore, the operation of communicating the upper and lower drug chambers 12A and 12B with each other and the operation of peeling off the inflow blocking weak seal portion 15 can be performed by a series of operations of pressing the drug chamber 12A from the outside. At this time, since the inflow blocking weak seal portion 15 for temporarily blocking the inflow of the drug into the port 14 is provided, the drugs in the upper and lower drug chambers 12A and 12B partitioned by the partition weak seal portion 13 are provided. It is possible to prevent the drug from being administered before the drug is mixed.
Further, when the drug chamber 12B is pressed from the outside, the partition weak seal portion 13 is peeled off before the inflow blocking weak seal portion 15, and the drug in the drug chamber 12A and the drug in the drug chamber 12B are mixed. In this state, since the weak seal portion 15 for preventing inflow is not peeled off, the drug does not flow out from the port 14. Therefore, when the chamber consisting of the drug chamber 12A and the drug chamber 12B from which the compartment weak seal portion 13 has been peeled off is pressed from the outside, the inflow prevention weak seal portion 15 is peeled off and the mixed chemical solution flows out from the port 14. Can be made to. As described above, it is possible to prevent the unmixed drug from being administered even when the drug chamber of the drug room 12A or the drug room 12B is pressed.
Further, even when an unexpected pressing force is applied such as during transportation, the curved band-shaped weak seal portion 15 for preventing inflow does not peel off, and the drug before mixing is surely prevented from being administered.
According to the configuration as described above, it is formed so as to project toward the partition weak seal portion 13 side and surround the port 14, and the inflow of the drug contained in the drug chambers 12A and 12B into the port 14 is temporarily provided. On the surface of the inflow blocking weak seal portion 15 for blocking, a groove 21 is formed in which the inflow blocking weak sealing portion 15 extends in a continuous direction. According to such a configuration, for example, when a force is applied to the medical multi-chamber container 1 from the outside and the pressure of the medicines contained in the medicine chambers 12A and 12B increases, the pressure is applied to the weak seal portion 15 for preventing inflow. On the other hand, the weak seal portion 15 for preventing inflow acts in the direction intersecting the continuous direction. On the other hand, since the inflow blocking weak seal portion 15 is formed with a groove 21 extending along the continuous direction of the inflow blocking weak sealing portion 15, it is possible to prevent the applied pressure from concentrating. ..
Further, the groove 21 is formed in the curved seal portion 15b that protrudes at least toward the section weak seal portion 13 in the inflow blocking weak seal portion 15. The pressure of the drug contained in the drug chambers 12A and 12B is particularly concentrated on the curved seal portion 15b protruding toward the section weak seal portion 13 in the inflow prevention weak seal portion 15. Therefore, by providing the groove 21 in the curved seal portion 15b, it is possible to effectively prevent the weak seal portion 15 for preventing inflow from being inadvertently peeled off.
Further, on the other surface of the inflow blocking weak seal portion 15, a plurality of recesses 22 spaced apart along a continuous direction of the inflow blocking weak sealing portion 15 are formed so as to face the groove 21. .. As a result, it is possible to more reliably prevent the weak seal portion 15 for preventing inflow from being inadvertently peeled off.
In this way, it is possible to prevent the weak seal portion 15 for preventing inflow from being inadvertently peeled off, and to improve the impact resistance of the weak seal portion 15 for preventing inflow due to vibration or dropping during handling such as during transportation. .. Therefore, even if a protective member is not used as in the prior art, the weak seal portion 15 for inflow prevention is not unintentionally peeled off due to an impact such as dropping, and the weak seal portion 15 for inflow prevention is easily opened when necessary. Can be done.
Further, by forming the groove 21 and the recess 22 so as to face each other, the peel strength when the sealing condition such as temperature changes, as compared with the case where the groove 21 and the recess 22 are displaced from each other. It is preferable because there is little change and a stable weak seal portion 15 for preventing inflow can be obtained.
Although the embodiment of the medical multi-chamber container according to the present invention has been described above, the present invention is not limited to the above embodiment and can be appropriately modified without departing from the spirit of the present invention.
For example, in the above-described embodiment, the groove 21 is formed as the linear seal portion and the recess 22 is formed as the point-like seal portion in the weak seal portion 15 for preventing inflow. However, when the films 11 and 11 forming the medical multi-chamber container 1 are made of a hard material, the weak seal portion 15 for preventing inflow is sealed by the molds 30A and 30B by heat welding, ultrasonic welding, or the like. , Grooves 21 and recesses 22 may not be formed.
Further, in the above-described embodiment, the medical multi-chamber container 1 is provided with two upper and lower drug chambers 12A and 12B, but three or more drug chambers are partitioned by a weak seal portion 13 for partitioning. May be good.
FIG. 9 is a plan view showing the configuration of the medical multi-chamber container according to another embodiment. Further, in the above-described embodiment, a medical multi-chamber container is exemplified as an example of the bag-shaped container, but a medical container having one drug chamber may be used, and a bag-shaped container having a peelable curved band-shaped weak seal portion may be used. As long as it is a container, it can be used for other purposes such as food use such as a combination of seasoning liquid and ingredients, and industrial use such as a two-component mixed type adhesive without being limited to this. For example, as in the medical multi-chamber container 110A according to another embodiment shown in FIG. 9, the curved band-shaped weak seal portion 115 divides the chamber 112 by the straight seal portions 115a and 115a and the curved seal portion 115b. It may be provided as follows.
In addition, it is possible to replace the components in the above-described embodiment with well-known components as appropriate without departing from the spirit of the present invention.
Next, an example for supporting the effect of the medical multi-chamber container according to the above-described embodiment will be described below.
[Example] The medical multi-chamber container shown in Fig. 1 was created as follows. The outer dimensions of the film are 40 cm x 30 cm in length and width. (Manufacturing of multilayer film) Using a multilayer film with the following structure prepared by the multi-layer coextrusion water-cooled inflation method, the container has the structure shown in Fig. 1, and the peeling strength and communication strength of the inflow blocking weak seal are measured and the container is packed. A drop test was conducted to confirm the function of the container.
The film is a multilayer film composed of the following resins, which is composed of an outer layer / adhesive layer / inner layer / inner layer surface layer, and each layer has a thickness of 15 μm / 20 μm / 200 μm / 15 μm. In the description of the resin below, the melt mass flow rate of the polyethylene resin (hereinafter referred to as "MFR") is a value measured at a temperature of 190 ° C and a load of 21.18 N in accordance with JIS K 7210. The MFR of the maleic anhydride graft-modified polypropylene is a value measured in the same manner as in the case of the polyethylene resin except that the temperature is set to 230 ° C. Outer layer: Polyamide 11, Rilsan B BESV OA FDA, manufactured by Arkema Co., Ltd. Adhesive layer: Maleic anhydride graft modified polypropylene, MFR 2.8g / 10 minutes Inner layer: linear low density polyethylene, density 917kg / m<sup>3</sup>, MFR 1.1g / 10 minutes Inner layer Surface layer: High density polyethylene, density 955kg / m<sup>3</sup>, MFR 1.8g / 10 minutes
(Manufacturing of weak seal for inflow prevention) For the weak seal part for blocking inflow, the following two sets of molds were used, and two films were sandwiched and heat-pressed so as to surround the port on the drug chamber side and heat-sealed. The seal width of the weak seal portion for inflow prevention is a constant width of 12 mm, the radius of curvature of the curved seal portion is 28 mm, the vertical height direction of the weak seal portion for inflow prevention is 44 mm, and the width direction of the left and right is 95 mm. Here, one of the two sets of molds has the configuration shown in FIGS. 6 and 7, and the top surface extending along the continuous direction of the weak seal for inflow prevention is a protrusion with a width of 0.4 mm. Was provided so that the gap between adjacent top surfaces was 0.6 mm. The other of the two sets of molds has the configuration shown in Fig. 8, and the top surface extending along the continuous direction of the weak seal for inflow prevention is a top surface with 0.4 mm wide ridges adjacent to each other. In addition to providing a gap of 0.6 mm between the top surfaces, a ridge having a width of 0.4 mm on the top surface extending in the vertical direction is provided so that the gap between adjacent top surfaces is 0.6 mm.
Using a set of these two molds, heat seal and peel off under the conditions of mold temperature 126 to 132 ° C, pressure 0.3 to 0.5 MPa, pressure holding time 2 to 8 seconds, and cooling time 4 to 12 seconds. A weak seal portion for inflow prevention having a strength of 7.5 N / 10 mm width (Example 1) and a strength of 10.5 N / 10 mm width (Example 2) was formed.
A weak seal for partitioning was provided at a position 18 cm in the long direction from the side with the port so as to be located in a straight band shape over both sides with a width of 1 cm. Heat-seal was performed under the conditions of film heating temperature 123 to 129 ° C, pressure 0.4 MPa, sealing time 5 seconds, and cooling time 4 seconds, and peel strength 3.0 N / 10 mm width (Example 1), 3.2 N / 10 mm width (implemented). A weak seal part for the section as shown in Example 2) was formed.
(External seal, port seal) Under the conditions of mold temperature 180 ° C, pressure 0.4MPa, pressure holding time 4 seconds, cooling time 4 seconds, heat seal the peripheral edge of the medical multi-chamber container, that is, the outer shape of the lower, upper and lateral sides of the film. Was sealed. In addition, the port was heat-sealed with a port seal mold to manufacture a medical multi-chamber container.
One drug chamber is filled with 1400 ml of purified water and the other drug chamber is filled with 600 ml of purified water through an opening formed by cutting a part of the container in two places, and the opening is sealed by heat sealing under the same conditions as the outer shape seal. It was destroyed. After heating with a shower-type high-pressure steam sterilizer at 106 ° C for 25 minutes, the mixture was cooled to obtain a medical multi-chamber container for evaluation.
[Comparison example] FIG. 10 is a plan view showing the mold surface of one mold used for the seal of the comparative example, and FIG. 11 is a plan view showing the mold surface of the other mold used for the seal of the comparative example. As a comparative example, the following two sets of molds having different surface shapes from those of Examples 1 and 2 are used to seal the weak seal part for partitioning and the weak seal part for preventing inflow for medical use. A multi-chamber container was formed. Here, as shown in FIG. 10, in one of the two molds 130A used in the comparative example, a linear sealing portion extending in the width direction of the container is formed on the surface of the container after sealing. As described above, the grooves 131 having an inverted triangular cross section with a straight line having a width of 0.6 mm extending in the width direction are formed so that the deepest portions of the grooves are evenly spaced by 1 mm in the vertical direction. Further, as shown in FIG. 11, in the other mold 130B of the pair, the grooves 132 having a straight cross section with an inverted triangle having a width of 0.6 mm extending in the width direction have the deepest portions of the grooves at equal intervals of 1 mm. In addition to being formed so as to be, grooves 133 having a width of 0.6 mm extending in the vertical direction are provided so that the deepest portions of the grooves are spaced by 1 mm in the width direction.
Then, using these two sets of molds, the conditions of mold temperature 126 to 132 ° C, pressure 0.3 to 0.5 MPa, pressurization holding time 2 to 8 seconds, and cooling time 4 to 12 seconds are the same as in the examples. A weak seal portion for preventing inflow was formed with a peel strength of 7.6 N / 10 mm width (Comparative Example 1) and 10.4 N / 10 mm width (Comparative Example 2).
In addition, the weak seal portion for the section was provided so as to be located in a straight strip shape from a position of 18 cm in the long direction from the side with the port to a width of 1 cm over both sides. Heat-seal is performed under the conditions of film heating temperature 123-129 ° C, pressure 0.4MPa, sealing time 5 seconds, and cooling time 4 seconds, peel strength 3.0N / 10mm width (Comparative Example 1), 3.3N / 10mm width (comparison). A weak seal part for the section as shown in Example 2) was formed.
(Evaluation of the physical properties) The peel strength of the weak seal part for blocking inflow, the peel strength of the weak seal part for partitioning, the communication strength, and the drop strength were tested and evaluated.
(Peeling strength of weak seal for inflow prevention) In the inflow prevention weak seal part, a rectangular test piece with a width of 10 mm and a length of 70 mm is cut out from the container on the extension line of the port so as to cross the inflow prevention weak seal part, and the test piece for the peel strength test. Got The obtained test piece was measured for T-type peel strength in accordance with JIS K 6854-3 at a tensile speed of 300 mm / min.
(Peeling strength of weak seal part for partition) A test piece for peel strength test was obtained by cutting out a strip-shaped weak seal for compartment and a rectangle with a width of 10 mm and a length of 70 mm at 90 degrees from the medical multi-chamber container to exceed the width of the weak seal for compartment. .. The peel strength of the test piece of the weak seal portion for the section was measured in the same manner as for the weak seal portion for preventing inflow.
(Communication strength) The communication strength is when the weak seal for partitioning is heat-sealed so that it does not communicate, and the drug chamber on the port side is pressed at 500 mm / min with a plate of 100 mm x 300 mm, and the weak seal for inflow prevention peels off and communicates. The strength of was measured.
(Drop strength) FIG. 12 is a schematic view showing the accommodation state of the medical multi-chamber container when the drop test is performed. A medicated multi-chamber container 1 having a size of 20 cm × 30 cm when folded in half at the section weak seal portion 13 was enclosed in an outer bag (not shown) consisting of a 40 cm × 30 cm square seal bag. Further, as shown in FIG. 12, in a cardboard box 100 having a size of 30 cm × 30 cm × 20 cm, a medical multi-chamber container 1 having a thick flat outer bag folded in half is placed on a 30 cm × 20 cm surface of the cardboard box. Five bags were stacked one above the other and packed in a direction parallel to the above. The medical multi-chamber container 1 with an outer bag was oriented so that 5 bags were stacked one above the other, and the cardboard box was dropped twice from a height of 80 cm. Of the five medical double-chamber containers 1 in outer bags, one medical double-chamber container 1 on the bottom side is subjected to the largest force because the load of the other four medical double-chamber containers 1 is also applied. , The weak seal portion 15 for preventing inflow and the weak seal portion 13 for partitioning are the containers that are easily peeled off. After the drop experiment, one medical multi-chamber container 1 on the bottom side was taken out, and the presence or absence of communication between the weak seal portion 15 for inflow prevention and the weak seal portion 13 for division was evaluated. Regarding the inflow prevention weak seal portion 15, the presence or absence of water in the area surrounded by the inflow prevention weak seal portion 15 and the lower seal portion 17C is visually observed, and the presence of water can be confirmed. The case where the presence of water could not be confirmed was evaluated as . Regarding the weak seal portion 13 for the section, the case where peeling was partially observed by visual observation was evaluated as x, and the case where no peeling was observed was evaluated as .
The evaluation results are shown in Table 1.<tables num="1"><img id="000003" he="198" wi="170" file="JP2016202467A_D0001.tif" img-format="tif" img-content="drawing" /></tables>
As shown in Table 1, in Example 1 and Example 2, although the communication strength in the weakly sealed portion for partitioning was slightly higher than that in Comparative Example 1 and Comparative Example 2, almost the same easy opening property was obtained. It was. On the other hand, regarding the drop strength, in Comparative Example 1 and Comparative Example 2, peeling occurred in the inflow blocking weak seal portion, but in Examples 1 and 2, peeling was not observed in the inflow blocking weak sealing portion. It was.
1 Medical multi-chamber container (bag-shaped container) 11 film 11f outer surface (surface) 11g outer surface (surface) 12, 12A, 12B Pharmacy room (room) 112 rooms Weak seal for 13 compartments 14 ports 15 Weak seal for inflow prevention (curved strip-shaped weak seal) 15b Curved seal (tip) 21 Groove (Linear seal) 22 Recess (dotted seal) 30A mold 30B mold 30f pressing surface 31 ridge
14 sheets
Sheet 1 Sheet 2 Sheet 3 Sheet 4 Sheet 5 Sheet 6 Sheet 7 Sheet 8 Sheet 9 Sheet 10 Sheet 11 Sheet 12 Sheet 13 Sheet 14
Every citation, both ways
| Document | Relation | Office | Category | Cited during | Relevant claims |
|---|---|---|---|---|---|
| US2018257835A1 | Cited by | United States of America | – | Search report | – |
| US10654632B2 | Cited by | United States of America | – | Search report | – |
| JP2018154374A | Cited by | Japan | – | Search report | – |
| JP2004000476A | Cites | Japan | A | Search report | - |
| JP2007007128A | Cites | Japan | Y | Search report | 1-3,5-7 |
| JP2007075276A | Cites | Japan | A | Search report | - |
| JP2009214924A | Cites | Japan | A | Search report | - |
| JP2015054203A | Cites | Japan | Y | Search report | 1-3,5-7 |
3 members in 2 offices
Priority claims2
| Document | Office | Kind | Date |
|---|---|---|---|
| 2015086451 | Japan | A | |
| JP20150086451 | – | – | – |
Members3
| Document | Office | Kind | |
|---|---|---|---|
| WO2016171118A1 | World Intellectual Property Organization (WIPO) | A1 | |
| JP2016202467AThis record | Japan | A | |
| JP6478400B2 | Japan | B2 |
13 legal events, as the office reported them to INPADOC
Over the term
Point at a mark for the eventEvents
| Event | Code | |
|---|---|---|
| Receipt of annual feesJAPANESE INTERMEDIATE CODE: R250R250 | R250 | |
| Receipt of annual feesJAPANESE INTERMEDIATE CODE: R250R250 | R250 | |
| Receipt of annual feesJAPANESE INTERMEDIATE CODE: R250R250 | R250 | |
| Receipt of annual feesJAPANESE INTERMEDIATE CODE: R250R250 | R250 | |
| Receipt of annual feesJAPANESE INTERMEDIATE CODE: R250R250 | R250 | |
| Certificate of patent or registration of utility modelJAPANESE INTERMEDIATE CODE: R150R150 | R150 | |
| First payment of annual fees (during grant procedure)JAPANESE INTERMEDIATE CODE: A61A61 | A61 | |
| Written decision to grant a patent or to grant a registration (utility model)JAPANESE INTERMEDIATE CODE: A01A01 | A01 | |
| Decision of grant or rejection writtenTRDD | TRDD | |
| Notification of appointment of power of attorneyJAPANESE INTERMEDIATE CODE: A7423RD03 | RD03 | |
| Request for written amendment filedJAPANESE INTERMEDIATE CODE: A523A521 | A521 | |
| Notification of reasons for refusalJAPANESE INTERMEDIATE CODE: A131A131 | A131 | |
| Written request for application examinationJAPANESE INTERMEDIATE CODE: A621A621 | A621 |
Numbers
- Publication
- 2016202467
- Publication, DOCDB
- 2016202467
- Publication, EPODOC
- JP2016202467
- Application
- 86451
- Application, DOCDB
- 2015086451
- Application, EPODOC
- JP20150086451
Titles2
- Japanese
- 袋状容器、医療用複室容器、金型および曲線帯状弱シール部の形成方法
- English
- Method for forming bag-shaped container, medical multi-chamber container, mold and curved band-shaped weak seal
Classification
- CPC, 2
- A61J1/10
- B65D81/32
- IPC, 2
- A61J1 05
- B65D81 32