JP6326522B2 - Multi-chamber container - Google Patents

Description

  This invention is configured as a bag (bag-like body) made of a flexible (soft) synthetic resin film for use in infusion, etc., and various types of drugs are individually stored by partitioning the inside with a peelable welded portion. The present invention relates to a multi-chamber container and a sealing method thereof.

  As an infusion bag for high calorie infusion for post-operative patients, etc., a liquid drug containing amino acids that may change in quality over time by mixing with a synthetic resin film, and a liquid drug containing glucose In recent years, what is separately housed in separate compartments partitioned by a weak seal portion (partition wall) has been widely used. Immediately before infusion, pressurize one of the drug solution storage parts from the outside with the palm of the hand, etc., so that the infusion bag is expanded and deformed at the connection with the weak seal part, and external pressure is applied to the weak seal part to separate the compartments The weak seal part can be peeled off and the both drugs can be mixed and used for infusion. As an improvement of such a two-component infusion bag, a small bag-like body has been proposed in the compartment for replenishment of micronutrients such as vitamins for patients who continue infusion over a long period of time. (Patent Documents 1-3). That is, in the techniques of Patent Documents 1 and 2, each multi-chamber container is composed of a container body formed of a synthetic resin film and a small container (inner container) housed inside the container body. Is weakly sealed at the opposing surface, and this weakly sealed portion is firmly attached (strongly sealed) to the opposing surface of the outer container body. Therefore, when the weak seal between the compartments is opened, the expansion and separation of the opposing surface of the container body leads to the opening of the inner container, and the medicine stored in the inner container is mixed with the medicine contained in the compartment. It becomes possible to discharge (infusion) from the discharge port.

  In the technique of Patent Document 3, the small container is arranged between the compartments and extends in the width direction, and the upper and lower sides of the small container are configured as sealing portions (weak seals), and the opening portion is the outer container. Is welded (strongly sealed) to the opposite surface. Therefore, when the container is expanded due to external pressure for communication with the compartment, the opening of the small container is peeled and opened, and the medicine contained in the inner container is mixed with the medicine contained in the compartment and discharged from the outlet. To be done.

  On the other hand, although not provided with an inner container, in addition to the weak seal portion (first partition) for partitioning the compartment, the weak seal portion (the external pressure value for opening is larger than this weak seal portion) ( The second partition) is provided close to the discharge port, and the chemical solution is mixed by opening the first partition, and then the second partition is opened by further pressurization to mix the drugs between the compartments. There has been proposed a method in which the discharge is performed after the occurrence of the occurrence of the problem (Patent Document 4).

Japanese Patent No. 4096200 Japanese Patent No. 4822860 JP 2004-313487 A Japanese Patent No. 4236131

  In Patent Documents 1-3, it is assumed that the opening of the weak seal portion is performed by pressurizing the chemical part in the compartment on the side away from the discharge port. Therefore, the inner container is the compartment on the side to be pressurized. By this, opening of the compartment and opening of the inner container can be interlocked. In addition, a precautionary statement regarding the necessity of opening work by applying pressure at a predetermined site (a compartment on the side away from the discharge port) prior to infusion is provided on the surface of the product so that the infusion is not performed without being opened. It is printed. However, in the prior art, the compartment on the discharge port side (lower side) opens directly to the discharge port. Therefore, if the infusion set is punctured without opening, the infusion solution from the lower compartment can be removed. In this case, the infusion may be performed without mixing the infusion solution or introducing a small amount of medicine.

  In Patent Document 4, in addition to the first partition between the compartments, a second partition is provided in front of the discharge port, and the external force for peeling and opening the second partition is made larger than that of the first partition. Although the order is the first partition and then the second partition, it does not include the inner container, and does not present any solution to the above-described problems in the infusion bag including the inner container.

  The present invention has been made in view of the above problems in a multi-chamber container containing an inner container. The first opening of the first partition between the compartments, and the opening of the second partition before the discharge port after that are performed. The purpose is to ensure that the opening sequence can be ensured and that the inner container is also reliably opened, so that the possibility of erroneous operations such as infusion with only some drugs can be reliably eliminated. And

The multi-chamber container of the present invention includes an outer container formed in a bag shape from a flexible film, a discharge port fixed to the outer peripheral portion of the outer container, for discharging a drug, and a side away from the discharge port. A first partition that partitions the inside of the outer container and can be opened by an external force to the outer container, and an outer container that partitions the interior of the outer container on the side close to the discharge port and has an external force that opens the first partition A second partition wall that can be opened by an external force, a first compartment that is formed inside the outer container on the side away from the discharge port of the first partition wall, and stores the first liquid medicine, and the first partition wall Formed in the outer container between the second partition and the second partition, formed in the outer container between the second compartment containing the second liquid medicine, the second compartment and the discharge port, and discharged. A discharge control chamber that communicates with the outlet and a flexible film. An inner container having a sealing portion which is disposed inside the discharge control chamber on the proximity side with the discharge port of the second compartment, accommodates the auxiliary medicine, and is configured to be openable along the outer periphery; The inner container is fixed to the opposing inner surface of the outer container along the compartment and the proximity side, and is provided with an external force applying part that applies an external force for opening the sealing part of the inner container.
The flexible film constituting the inner container can be thermoformed with a recess for forming a cavity for containing the medicine.

  The second partition wall has a sealing portion of the inner container on the side close to the second compartment and a second side end portion of the sealing portion of the inner container on the side close to the second compartment. The separation chamber and the discharge control chamber can be connected to each other so as to be separated.

  At the second container side end of the inner container along the external force applying part, the fixing part of the inner container to the opposing inner surface of the outer container in the external force applying part is on the second compartment side from the sealing part of the inner container. Can be extended somewhat. Further, it is possible to prevent the fixing portion from substantially covering the sealing portion of the inner container.

  An auxiliary external force imparting portion that locally fixes the side of the inner container sealing portion that is separated from the second compartment to the opposing surface of the outer container can be provided. A pair of auxiliary external force applying portions (local seal portions) can be installed so as to sandwich the discharge port.

  The present invention also provides a sealing method for a multi-chamber container as described above, in which an outer container whose outer periphery is unsealed on the side separated from the compartment is prepared, and on the other hand, an auxiliary drug is accommodated inside and the outer periphery is sealed by a sealing portion Prepare a sealed inner container, insert the inner container into the outer container from the unsealed part, and weld the sealed part of the inner container to the opposing inner surface of the outer container on the side close to the compartment and the external force applying part The present invention provides a sealing method for a multi-chamber container. And the flexible film which comprises an inner side container is provided with the inner layer of the welding temperature higher than the welding temperature for external force provision part formation, and the flexible film which comprises an inner side container is with a compartment. External force applying unit using a sealing mold having a heating surface with a size that includes an extending portion extending from the sealing portion on the near side to the compartment side and also covers the extending portion for forming the external force applying portion. Can be sealed.

  At the time of manufacturing the inner container in the multi-chamber container, the center part in the width direction of the flattened bag-like film sheet is center-sealed so that it can be peeled off and opened by cutting both closed ends, and the center seal is opened via the sheet opening part. A liquid injection nozzle is inserted so as to follow, and a cavity is formed by forming a bottom seal with side seals and cross seals so as to be peelable from the sheet by a seal mold, and after feeding the sheet, the cavity A predetermined amount of drug is injected from the liquid injection nozzle, and the top side of the cavity after the drug injection is closed by a cross seal. In this way, while appropriately cooperating with the sheet feeding, the steps of defining the cavity closed at the bottom by the side seal and the cross seal, injecting the drug, and closing the top by the cross seal are repeated, and the sheet is It is composed of a chain of filling parts. In the next step, the protective film is detachably attached to the sheet surface that is the outermost surface when the inner container is used, and the protective film is peeled off when being attached to the outer container.

  The cavity into which the chemical solution is injected can be a cavity whose shape is fixed by pressure-molding the film at the outer diameter part (injection body) of the injection nozzle with a seal mold at the time of sealing.

  An external force is applied by arranging the inner container inside the outer container between the second compartment and the discharge control chamber, and fixing the inner container to the opposing inner surface of the outer container along the second compartment and the adjacent side. And the external pressure for opening the second partition is larger than that of the first partition, so that the second container is opened in conjunction with the opening of the second partition following the opening of the first partition. The sealing portion can be opened, and the medicine stored in the first and second compartments can be reliably mixed with the medicine stored in the inner container and introduced into the discharge port.

  Moreover, the opening side of the inner container by an external force is not impaired by allowing the second partition wall to form a side closer to the second compartment in the sealing portion of the inner container, and the outer container is limited. The internal space can be used effectively, while the outer surface of the inner container can be kept open to the discharge control chamber on substantially the entire surface (other than the welded portion), and a small amount accommodated in the discharge control chamber during sterilization. The inner container and the discharge control chamber can be sterilized with the water vapor for injection.

  By fixing the inner container to the second inner compartment side of the inner container facing the opposite inner surface of the outer container at the outer force applying section, the outer force due to the expansion between the films constituting the outer container at the time of opening is sealed. It can be transmitted efficiently to the stop and can be efficiently opened.

  By effectively fixing the sealing portion of the inner container to the opposing inner surface of the outer container locally by the auxiliary external force imparting portion on the side away from the second compartment, the external force applied to the second partition is efficiently Can contribute to the unsealing. On the other hand, the inner container remains exposed to the discharge control chamber on substantially the entire outer surface, and the sterilization function of the inner container is not impaired. In addition, the auxiliary external force imparting portion prevents the inner container from collapsing when the inner container is pulled into the second compartment due to the container shape, and properly maintains the inner container's attitude when opened. In addition, a smooth opening operation of the inner container can be realized.

  By cutting the inner container into individual ones from the chain of drug filling parts that seal and fill from the bag-like film sheet, it becomes possible to efficiently manufacture the inner container and to contain the drug at the time of sealing. By heating and molding the hollow portion, the convex shape of the sheet is fixed and it is difficult to be crushed, so that a small volume portion for a small amount of medicine can be ensured. In addition, it is possible to prevent adhesion of foreign matters and to ensure aseptic conditions until the protective film is attached to the outer container.

FIG. 1 is a plan view of a multi-chamber container according to the first embodiment of the present invention. 2 is a cross-sectional view taken along the line II-II in FIG. 3 is a cross-sectional view taken along line III-III in FIG. 4 is a cross-sectional view taken along the line IV-IV in FIG. FIG. 5 is a diagram schematically showing steps (a) to (c) in the manufacturing process of the multi-chamber container of FIG. FIG. 6 schematically shows this stage (d)-(f) following FIG. FIG. 7 is a cross-sectional view taken along the line VII-VII in FIG. 5C, and the inner bag is welded to the resin material constituting the outer bag by the seal mold when forming the strong seal portion as the external force imparting portion ( It is a figure which shows a and (b) roughly. FIG. 8 is a plan view of a multi-chamber container according to the second embodiment of the present invention. 9 is a cross-sectional view taken along the line IX-IX in FIG. FIG. 10 is a plan view of a multi-chamber container according to the third embodiment of the present invention. FIG. 11 is a plan view of a multi-chamber container according to the fourth embodiment of the present invention. 12 is a cross-sectional view taken along line XII-XII in FIG. 13 is a cross-sectional view taken along line XIII-XIII in FIG. FIG. 14 is a plan view of a multi-chamber container according to the fifth embodiment of the present invention. FIG. 15 is a plan view of a multi-chamber container according to the sixth embodiment of the present invention. 16 is a cross-sectional view taken along line XVI-XVI in FIG. FIG. 17 is a partial view in FIG. 16, but is a diagram schematically showing the positional relationship between the seal mold, the outer bag, and the inner bag when forming a strong seal as the external force applying portion. FIG. 18 is a plan view of a multi-chamber container according to the seventh embodiment of the present invention. FIG. 19 is a plan view of a multi-chamber container according to the eighth embodiment of the present invention. 20 is a schematic side view of the inner bag manufacturing apparatus in the multi-chamber container of FIG. FIG. 21 is a schematic front view of the inner bag manufacturing apparatus in the multi-chamber container of FIG. 22 is a schematic cross-sectional view of a film constituting the inner bag in the multi-chamber container of FIG. 23 is a cross-sectional view taken along the line XXIII-XXIII in FIG. 24 is a cross-sectional view taken along the line XXIV-XXIV in FIG. 25 is a cross-sectional view taken along line XXV-XXV in FIG. 26 is a cross-sectional view taken along the line XXVI-XXVI in FIG. 20, (a) shows a state before the combination of the seal molds, and (b) shows a state after the combination. 27 is a cross-sectional view taken along line XXVII-XXVII in FIG.

  Hereinafter, a first embodiment of the multi-chamber container of the present invention implemented as an infusion bag will be described. In FIG. 1, 10 is an outer bag (outer container of the present invention) formed by inflation or the like, and has a thickness of 200 μm. A synthetic resin soft film having a multilayer structure such as a polyethylene film (the flexible film of the present invention) is used as a raw material. The outer bag 10 is substantially flat and has a substantially rectangular shape. As shown in FIGS. 2 and 3, the synthetic resin soft film constituting the outer bag 10 includes a pair of (upper and lower) film pieces 12 and 14. The outer periphery is entirely formed in a bag shape by non-peelable welding along the opposing surface, that is, strong sealing. This strong seal portion along the outer bag 10 is denoted by reference numeral 16 in FIG. When the strong seal portion 16 is welded, the sealing surface does not peel off even when the chemical solution storage portion of the outer bag 10 is pressurized from the outside. The welding temperature and the welding time are set so that the above is maintained. A discharge port 18 is fixed to the strong seal portion 16 at the lower portion of the outer bag 10, and a mixed injection port 20 is fixed to the upper portion of the outer bag 10 so as to maintain a fluid-tight state. The discharge port 18 and the mixed injection port 20 of the outer bag 10 are molded with a material of the same quality as a mold in order to improve the weldability with the synthetic resin soft film constituting the outer bag 10. That is, when the outer bag 10 is made of polyethylene, the discharge port 18 and the mixed injection port 20 are also made of polyethylene. The discharge port 18 and the mixed injection port 20 are integrated with the outer bag 10 by welding to the upper and lower film pieces 12 and 14 so as not to be peeled off. In order to integrate the outer bag 10 with the discharge port 18 and the mixed injection port 20, the film pieces 12 and 14 constituting the outer bag 10 are liquid-tight all around the discharge port 18 and the mixed injection port 20. The outer bag 10 is welded (strongly sealed) so as not to be peeled off so as to be connected to the strong seal portion 16 on the outer periphery of the outer bag 10 without a break. The welded portions of the strong seal portion 16 with the discharge port 18 and the mixed injection port 20 are represented by 16A and 16B (FIG. 1). The discharge port 18 and the mixed injection port 20 are molded products of thick synthetic resin capable of maintaining the cylindrical shape, and the structure thereof is basically the same. However, the discharge port 18 will be described. 2 includes a cylindrical main body 22, a cap 24, and a rubber plug 26. The cylindrical main body 22 is integrated with the outer bag 10 at the distal end portion 22-1, by the welded portion 16A. 22 protrudes to the outside of the outer bag 10 through a tapered portion 22-2, and a cap 24 is fixed (welded) to an end portion of the cylindrical main body 22 with a rubber plug 26 interposed therebetween. The rubber stopper 26 is for puncturing the needle of the infusion set. The co-injection port 20 (FIG. 1) has a configuration similar to that of the discharge port 18. Although not shown, the co-injection port 20 is provided with a rubber plug similar to the rubber plug 26 of the discharge port 18, and punctures the needle for mixed injection. Can be done.

  In this embodiment, the strong seal portion (non-peelable weld portion) and the weak seal portion (peelable weld portion) are all formed by welding the film facing surface, but the cross-section (FIGS. 2, 3, 4 and others) 9, 12, 13, 16, and 17), the welded portions in the strong seal portion and the weak seal portion are indicated by bold lines (the strong seal is a solid line and the weak seal is a broken line). It expresses.

  An opening 27 (FIG. 1) is formed at the upper portion of the outer peripheral strong seal portion 16 of the outer bag 10 for suspension on an infusion stand during infusion.

  In FIG. 1, reference numeral 28 denotes a weak seal portion (first partition wall of the present invention) formed by welding the upper and lower film pieces 12 and 14 constituting the outer bag 10 so as to be peelable on the opposing surfaces (FIG. 2). And FIG. 3). The weak seal portion 28 extends across the entire width of the intermediate portion in the height direction of the outer bag 10, that is, so as to be integrally connected to the strong seal portion 16 to the strong seal portion 16 on both sides of the outer bag 10. Therefore, the inner space of the outer bag 10 is separated into upper and lower first and second compartments 29 and 30. Liquid medicines are stored in the first and second compartments 29 and 30 individually (in a separated state), but liquid medicines contain amino acid-containing chemicals and glucose, respectively, for high-calorie infusions. It is a chemical solution to When the weak seal portion 28 is welded, the seal surface is peeled off due to the expansion deformation of the outer bag 10 at the connection portion with the weak seal portion 28 when the chemical solution housing portions of the compartments 29 and 30 are pressurized from the outside. Thus, the welding temperature and the welding time are appropriately set. Since both the strong seal portion 16 and the weak seal portion 28 are facing surfaces of the same polyethylene film, the melting point of polyethylene> the seal temperature of the strong seal portion 16> the seal temperature of the weak seal portion 28. Specifically, the seal temperature of the strong seal portion 16 (also a later-described strong seal portion 42) between the polyethylene films is about 150 ° C., and the seal temperature of the weak seal portion 28 is about 130 ° C.

  The inner bag 32 (inner container of the present invention) is for storing auxiliary drugs such as vitamins for high calorie infusion. The inner bag 32 is a flat and elongated rectangle, and is accommodated between the lower compartment 30 and the discharge port 18 inside the outer bag 10. The inner bag 32 is connected and fixed to the outer bag 10 by an external force applying portion (strong seal portion 42), which will be described later, and is opened in response to the fluid pressure inside the outer bag 10. The outer edge of the inner bag 32 that is fixed inside the strong seal portion and overlaps the strong seal portions 16 and 42 is indicated by a broken line 32 'in FIG. The inner bag 32 is made of a multi-layer polyethylene film, like the outer bag 10, as in the case of the outer bag 10, but has a special surface layer that is in direct contact with chemicals for chemical resistance. For example, when a trace amount or a trace amount of drug is vitamin, a cyclic polyolefin resin (COP) surface layer (a layer that becomes the inner surface of the inner bag 32) is formed on a base material layer made of a multilayer polyethylene film. Can do. The polyethylene layer and the COP resin layer constituting the base material layer can be molded into a bag shape in a strongly integrated state under heating by inflation molding due to the strong affinity between the resins. Refer to the description of FIG. 23 regarding another embodiment shown in FIG. 19 about the structure of the multilayer film which comprises the inner bag 32. FIG. As shown in FIG. 2, the inner bag 32 is composed of upper and lower film pieces 34 and 36. In this embodiment, only one liquid is accommodated for the sake of simplicity. This welded portion is configured as a weak seal portion 38 (sealing portion of the present invention), and forms a drug containing chamber 39 therein, in which a trace amount drug such as vitamin is stored. Since the inner bag 32 has a rectangular shape, the weak seal portion 38 includes left and right side portions 38-1, 38-2 and upper and lower side portions 38-3, 38-4 as shown in FIG. The welding temperature and welding time are set so that the value of the external force for peeling and opening the weak seal portion 38 is appropriately larger than the value of the external force for peeling and opening the weak seal portion 28 between the compartments 29 and 30. Is done. Accordingly, due to the later-described fixing structure of the inner bag 32 to the outer bag 10, mixing of the chemical solution between the compartments 29 and 30 by opening the weak seal portion 28 by external force, and then a minute amount to the mixed chemical solution by opening the weak seal portion 38. A series of opening orders of drug introduction can be ensured. Since the weld surface of the weak seal portion 28 is a polyethylene film and the weld surface of the weak seal portion 38 is a cyclic polyolefin resin film, the welding conditions are set separately for the same peelable seal, and the weak seal portion 28 is opened. Therefore, it is necessary to set the external force to be less than the external force for opening the weak seal portion 38. Even in the same openable weak seal portion, the weak seal 28 that partitions the compartments 29 and 30 is made of polyethylene film and has a temperature of about 130 ° C. as described above. The sealing temperature of the portion 38 is a weld between the cyclic polyolefin resin films, and the melting temperature of the material becomes high. Therefore, it is necessary to set the external force for opening the weak seal portion 28 <the external force for opening the weak seal portion 38. In addition, even a weak seal increases to about 180 ° C.

  The discharge control chamber 40 is formed inside the outer container 10 between the lower compartment 30 and the discharge port 18 and is always open to the discharge port 18. The inner bag 32 is disposed inside the discharge control chamber 40 between the second compartment 30 and the discharge port 18 in a general positional relationship with the inner bag 32.

  Next, the fixing structure of the inner bag 32 with respect to the outer bag 10 in the embodiment of the present invention will be described in detail. In this embodiment, the inner bag 32 is near the full width of the outer bag 10, that is, slightly on the left and right side edges of the outer bag 10. In other words, the width of the inner bag 32 is somewhat narrower than the width of the outer bag 10. As will become clear from the infusion bag manufacturing process described later with reference to FIGS. 5 and 6, both ends of the upper portion 38-3 and the left and right side portions 38-1 and 38-38 of the weak seal portion 38 (sealing portion) of the inner bag 32. -2 is sandwiched between the film pieces 12 and 14 constituting the outer bag at the outer edge, and the strong seal portion 16 is somewhat widened at this portion to form the wide portion 16-1 (inner bag). As long as it can hold 32, it may be the same width without being wide). Both ends in the width direction of the upper portion 38-3 of the weak seal portion 38 of the inner bag 32 are integrated by being strongly sealed between the upper and lower film pieces 12 and 14 in the wide portion 16-1 of the strong seal portion 16, and the lower side The lower edge of the compartment 30 is partitioned, and the lower compartment 30 and the discharge control chamber 40 are separated in a liquid-tight manner. That is, the upper portion 38-3 of the weak seal portion 38 of the inner bag 32 (the weak seal portion 38 on the side close to the second compartment 30 of the inner container) and the wide portion 16-1 (inner side of the strong seal portion 16). The connection of the present invention in which the weak seal portion 38 on the proximity side of the container to the second compartment 30 is connected to the opposite outer peripheral side portion 16 of the outer container at both ends so as to separate the lower compartment 30 and the discharge control chamber 40 from each other. Constitutes the second partition wall of the present invention in this embodiment. That is, in the lower compartment 30, the weak seal portion 28 as the first partition and the upper portion 38-3 of the weak seal portion 38 of the inner bag 32 are integrated with the wide portion 16-1 of the strong seal 16. And the second partition configured by the above. Although the discharge control chamber 40 is always open to the discharge port 18 as described above, in this embodiment, the upper portion 38-3 of the weak seal portion 38 of the inner bag 32 is connected to the wide portion 16-1 of the strong seal 16. The second partition configured by integrating the upper and lower ends of the discharge control chamber 40 is divided. The discharge control chamber 40 plays a role of guiding the drug solution in the compartments 29 and 30 to the discharge port 18 together with a small amount of drug in the inner bag 32 when the weak seal portion 38 is opened. The structure of this embodiment in which the upper portion 38-3 of the weak seal portion 38 of the inner bag 32 is also used as the second partition wall serving as the lower edge of the lower compartment 30 is effective in the limited inner space of the outer bag 10. On the other hand, the outer surface of the inner bag 32 remains open to the discharge control chamber 40 except for the welded portion (38-3, 38-1, 38-2, 44) with the strong seal (16, 42). Therefore, it is advantageous for sterilization of the inner bag 32 as described later. In this embodiment, the left and right side portions 38-1, 38-2 of the weak seal portion 38 of the inner bag 32 are also sandwiched between the film pieces 12, 14 constituting the wide portion 16-1, and are strongly sealed. Yes. That is, the strong seal portion 16 (wide portion 16-1) which is welded to both ends of the upper portion 38-3 of the inner bag 32 and constitutes the connecting portion of the present invention is connected to the right and left and right side portions of the inner bag 32. The structure is strongly welded to 38-1 and 38-2. In this structure, the left and right side portions 38-1, 38-2 of the inner bag 32 are held at the time of opening, so that external force is concentrated on the upper side portion 38-3 and the lower side portion 38-4 of the inner bag 32 to This is advantageous in that it can be opened and contribute to the smooth discharge of the chemical.

  Next, the fixing structure of the inner bag 32 with respect to the outer bag 10 for opening the inner bag 32 by an external force with respect to the outer bag 10 will be described in detail. The inner bag 32 is in the width direction of the weak seal portion 38 along the outer periphery. The left and right side portions 38-1, 38-2 (FIG. 1) are strongly welded between the upper and lower film pieces 12 and 14 constituting the strong seal portion 16 (wide portion 16-1) of the outer bag 10, and the upper portion 38 -3 (FIGS. 1, 3 and 4) is strongly sealed (non-peelable weld = fixed) to the opposing surfaces of the upper and lower film pieces 12 and 14 of the outer bag 10 along the entire width. A strong seal portion of the upper portion 38-3 of the inner bag 32 with respect to the opposing surface of the outer bag 10 is denoted by reference numeral 42, and the strong seal portion 42 (external force applying portion of the present invention) is the left and right side portions of the strong seal portion 16. So as to be integrally connected to the upper side portion 38-3 of the weak seal portion 38 of the inner bag 32 (see FIGS. 2 and 3). Due to the strong seal portion 42, the inner bag 32 is fixed to the inside of the outer bag 10 on the side close to the second compartment, and the inner bag 32 is opened and opened by receiving the hydraulic pressure generated by pressurizing from the outside. Can be achieved. The inner bag 32 is free from the outer bag 10 except for the point seal portion 44 described below with respect to the lower side portion 38-4 (on the side close to the discharge port 18) of the weak seal portion 38 along the outer periphery (non-side). Welding). Therefore, the non-welded portion on the outer surface of the inner bag 32 can be opened in the discharge control chamber 40. The discharge control chamber 40 can be filled with a small amount of water for sterilization under wet heat in the manufacturing process of the infusion bag. The inner bag 32 has an outer portion at the central portion in the width direction on the lower side portion 38-4 of the weak seal portion 38 along the outer periphery (the side of the inner bag 32 that is separated from the second compartment 30). A strong seal (so-called point seal) is locally applied to the opposing surface of the bag 10, and this local strong seal portion (auxiliary external force applying portion of the present invention) is represented by 44 (see also FIG. 2). The local strong seal portion 44 can contribute to the opening of the entire circumference of the inner bag 32 by external force and the maintenance of the posture at the time of opening. Since the strong seal portion 42 as the external force imparting portion of the present invention is a weld of the outer surface of the inner bag 32 to the inner surface of the outer bag 10, it is a weld between polyethylenes, and the welding temperature is about 150 ° C. as described above. Even when sandwiched between molds, the inner surfaces of the inner bags 32 made of cyclic polyolefin are not welded to each other, and the strong seal portion 42 and the weak seal portion 38 (the upper portion 38-3) of the inner bag are formed. Even in the arrangement of the stacked embodiments, the weak seal portion 38 remains the weak seal portion.

  The external force imparting portion of the present invention that transmits the external force to the outer bag 10 when the infusion bag is opened to the inner bag 32 for opening the infusion bag is constituted by a strong seal portion 42, and the strong seal portion 42 is a weak seal portion 38 of the inner bag 32. Are provided in the width direction so as to overlap the upper portion 38-3 in the vertical direction. 2 and 3, the strong seal portion 42 (the welded portion between the opposing surfaces is indicated by a thick solid line) and the upper portion 38-3 of the weak seal portion 38 are substantially full width perpendicular to the paper surface. It extends to. In the upper portion 38-3 of the weak seal portion 38 of the inner bag 32 (the welded portion between the opposing surfaces is indicated by a thick dotted line), the upper and lower synthetic resin film pieces 34, 36 constituting the inner bag 32 are substantially full width. The edge portions 34-1 and 36-1 of the upper and lower synthetic resin film pieces 12 and 14 forming the outer bag 10 are somewhat extended into the compartment 30 along the inner surfaces thereof. -1 and 36-1 are strongly welded to the opposing surfaces of the upper and lower film pieces 12 and 14 constituting the outer bag 10 (the welded portion of the edge portions 34-1 and 36-1 in the strong seal portion 42 is 42 '). Naturally, the inner surfaces of the edge portions 34-1 and 36-1 of the film pieces 34 and 36 constituting the other inner bag 32 are separated from each other. In other words, the outer bag 10 is configured as compared with the welded portion (upper portion 38-3 of the weak seal portion 38) indicated by the thick dotted line between the inner surfaces of the film pieces 34 and 36 constituting the inner bag 32. A welded portion (strong seal portion 42) indicated by a thick solid line between the inner surfaces of the upper and lower film pieces 12 and 14 and the outer surfaces of the film pieces 34 and 36 constituting the inner bag 32 extends further to the compartment (30) side. Yes. The upper and lower film pieces 12, 14 constituting the outer bag 10 are extended portions 34-1 on the compartment (30) side in the film pieces 34, 36 constituting the inner bag 32 at the strong seal portion 42 (42 ′). In this structure, which is strongly welded to 36-1, the external force due to the expansion between the film pieces 12, 14 constituting the outer bag 10 at the time of opening is applied via the edge portions 34-1, 36-1 on the compartment side. This enables efficient transmission to the weak seal portion 38 of the inner bag 32, particularly the upper side portion 38-3 that is the starting point for opening the inner bag 32, and helps to ensure the opening of the inner bag 32. be able to.

  In the present invention, the resin layer constituting the inner surface of the inner bag 32 is a cyclic polyolefin-based resin film or the like, and the outer bag 10 and the same material (polyethylene) are formed thereon (in relation to the embodiment of FIG. 19). However, the melting temperature of the resin (cyclic polyolefin resin, etc.) constituting the inner surface of the inner bag 32 is considerably higher than the melting temperature of the resin (polyethylene, etc.) constituting the upper layer. The inner bag 32, which contains the medicine and is weakly sealed on the outer periphery (38), is accommodated inside the outer bag 10, and is clamped from the outside with a seal fitting, so that the inner surface of the outer bag 10 and the outer surface of the inner bag 32 are separated. Even if a strong seal (42, 42 ', 44) is made between the polyethylene films in the embodiment (seal temperature is about 150 ° C.), the inner surfaces of the inner bag 32 (the cyclic polyolefin resin films in the embodiment) are For welding It does not Rukoto, nor would proper weak seal state of the weak seal part 38 of the inner bag 32 (sealing temperature is about 180 ° C.) is impaired by the temperature of the sealing fitting.

  (A)-(f) of FIG.5 and FIG.6 demonstrates orderly an example of the manufacturing process of the infusion bag of 1st Embodiment, The cylindrical synthetic resin film is wound by the roll, The sheet drawn from the roll is strongly sealed and weakly sealed according to the contour shape of the infusion bag, and the outer bag material 48 becomes a strong and weak seal in the product on the cylindrical polyethylene multilayer film sheet drawn from the roll. A strong seal and a weak seal are applied in advance including a part of the portion (the upper and lower opposing surfaces of the tubular sheet are welded), and then trimmed according to the contour of the outer bag 10. The outer peripheral portion of the material 48 is strongly sealed in some places, and this becomes a part of the strong seal portion 16 (FIG. 1) of the product. The weak seal portion 28 has already been formed. The unsealed part which becomes the attachment part of the mixed injection port later is indicated by 48-1.

  The next step (b) shows the step of inserting the previously manufactured inner bag 32. As already described with reference to FIGS. 1 to 4, the inner bag 32 has a weak seal portion 38 on the outer periphery, a trace amount of medicine is already stored therein, and is covered with a protective film capable of separating the front and back surfaces. Provided in the state. The width W1 of the inner bag 32 is somewhat narrower than the width W2 of the material 48 serving as the outer bag, and the end portion 48-2 of the material 48 on the outer bag discharge port mounting side is not welded. After the inner bag 32 is peeled off the protective film on the front and back surfaces between the upper and lower film pieces in 48-2, it is cut individually and inserted to a predetermined position (arrow A). A specific example of the inner bag manufacturing process will be described later in connection with the embodiment of FIG.

  Step (c) shows a step of fixing (strong sealing) to the inner bag material 48 after insertion. In the outer peripheral weak seal portion 38 of the inner bag 32 by sandwiching a seal mold in which a pair of opposed heating surfaces extend in the width direction. The inner side (compartment side) side portion 38-3 is strongly welded to the opposing inner surface of the outer bag material 48 to form a strong seal portion 42 (including the portion 42 'in FIGS. 2 and 3), and at the same time a strong seal portion. 16, a wide portion 16-1 where the side portions 38-1 and 38-2 of the inner bag 32 are fixed is also formed. The seal mold for forming the strong seal portion (42) has a heating surface having a size corresponding to the size of the strong seal portion, but the inner surface and the inner surfaces of the film pieces 12, 14 constituting the outer bag 10. The outer surfaces of the films 34 and 36 constituting the bag 32 are polyethylene films, and at the temperature of about 150 ° C. as described above, the side of the compartment 30 of the inner bag 32 shown in FIGS. A strong seal is formed up to the extended end portions 34-1 and 36-1, and a strong seal portion 42 (also indicated by 42 ') is formed. Naturally, the sealing mold pressurizes the inner surfaces of the extended end portions 34-1 and 36-1 toward the compartment 30 in the film pieces 34 and 36 constituting the inner bag 32. Since the cyclic polyolefin-based resin constituting the inner surface has a high melting temperature, in the sealing mold heated to about 150 ° C., the extended end portion 34 − of the film pieces 34, 36 constituting the inner bag 32 toward the compartment 30 side 1, 36-1 is not welded between the inner surfaces. The heat of the sealing mold is also applied to the weak seal portion 38 of the inner bag 32, but the weak seal portion 38 remains weakly sealed.

  FIGS. 7A and 7B are cross-sectional views schematically showing the formation of the strong seal portion 42 by the seal mold. The mold extends to the upper die 102 and the lower die 104 (full width in the direction perpendicular to the plane of FIG. 6). The outer bag material 48 and the inner bag 32 are sandwiched between the upper and lower dies 102 and 104 heated to a predetermined temperature such as about 150 ° C., and the outer bag material 48 and the inner bag 32 face each other. As shown in FIG. 7A, the surfaces are brought into close contact with each other under heating by the upper and lower dies 102, 104. At this time, not only the sealing portion 38-3 but also the extended end portions 34-1 and 36-1 from the sealing portion 38-3 in the film pieces 34 and 36 constituting the inner bag 32 are heated and pressurized. . Therefore, not only the outer surface of the sealing portion 38-3 but also the outer surfaces of the extended end portions 34-1 and 36-1 are strongly sealed to the opposing inner surface of the outer bag material 48 due to the low melting temperature. Further, since the inner surfaces of the extended end portions 34-1 and 36-1 are high melting temperature layers, welding does not occur regardless of the pressurization under heating by the dies 102 and 104. The sealing portion 38-3 is maintained as a weak seal regardless of the heat from the sealing mold because of the high melting temperature (about 180 ° C. as described above) of the resin film layer constituting the inner surface. After a predetermined welding time has elapsed, the upper and lower dies 102 and 104 are separated as shown in FIG. By strongly welding (thick solid line) the inner surface of the outer bag material 48 and the outer surface of the inner bag 32, a strong seal portion 42 is formed, and the outer surfaces of the extended end portions 34-1 and 36-1 are also outer bag materials. 48 is strongly sealed (represented by a thick solid line) and the sealing portion 38 (lower side portion 38-4) remains weakly sealed (thick broken line), and the inner bag 32 relative to the outer bag 10 in FIG. The mounting structure is obtained. It should be noted that the positional relationship between FIGS. 3 and 7 is opposite in the drawing.

  In step (d) shown in FIG. 6, the end 48-4 on the discharge port side of the material 48, which is a part of the strong seal portion 16 on the outer periphery of the outer bag, is strongly sealed, and the inner bag 32 is removed on the discharge port side. A point seal portion 44 (FIG. 2) that is fixed to the bag facing surface is also formed, but the portion 48-5 is left unsealed as an opening for mounting the discharge port 18.

  In the step (e), the discharge port 18 is attached to the unsealed part 48-5 and strongly sealed, which has already been described with reference to FIGS. The mixed injection port 20 is inserted into the remaining portion 48-1 (see also FIG. 5 (a)), and is strongly sealed in the same manner as the discharge port 18, and strong sealing portions 16A and 16B (see also FIG. 1) are formed. The As a result, the discharge control chamber 40 is sealed. Prior to the formation of the sealing of the discharge control chamber 40, a small amount of distilled water is filled for sterilization under wet heat described later. In this state, the parts 48-6 and 48-7 of the material 48 remain unsealed.

  In the next step, the respective chemical solutions are filled from the unsealed portions 48-6 and 48-7 of the material 48 (arrows B and C). The chemical solution filling can be performed simultaneously. After the chemical solution is filled, the unsealed portions 48-6 and 48-7 are strongly sealed, and the compartments 29 and 30 filled with the respective chemical solutions are obtained. (F) shows what was completed as an infusion bag (same as that of FIG. 1).

  The completed infusion bag is then sterilized by a steam sterilizer. The inner bag 32 of the infusion bag has side portions 38-1, 38-2 and a side portion 38-3 on the second compartment side fixed to the outer bag facing surface by strong seal portions 16, 42, but on the outlet side The side portion 38-4 is only fixed to the outer bag facing surface at the point seal portion 44, and the inner bag 32 is exposed to the discharge control chamber 40 on the entire outer surface except for the strong welding portion. The outer surface of the inner bag 32 can be sterilized under wet heat. That is, the filling water to the discharge control chamber 40 in the step (e) evaporates by heating with a steam sterilizer and fills the discharge control chamber 40 as water vapor, and the outer surface of the inner bag 32 is entirely wetted with heat. It can be sterilized efficiently.

  In the infusion bag according to the embodiment described above, the infusion opening is performed by placing the infusion bag on a table such as a desk and pressurizing one or both of the drug solution housing portions of the compartments 29 and 30 with the palm from the outside. When pressurization is performed only on the side of the compartment 29 on the side of the mixed injection port 20, the outer bag 10 is expanded at the connection portion with the weak seal 28 on the side of the compartment 29, and the compartments 29 and 30 are partitioned. The weak seal 28 is first opened by an external force applied to the weak seal 28. On the other hand, when both the compartments 29 and 30 are pressurized or only the compartment 30 on the discharge port 18 side is pressurized, the outer bag 10 is connected to the weak seal 28 on the compartment 30 side and the weak seal. 38 is also expanded at the connection site to 38 (upper part 38-3). The force transmission to the connection portion of the weak seal 38 to the upper portion 38-3 is due to the synthetic resin film piece constituting the outer bag 10 being fixed to the upper portion 38-3 of the weak seal 38 by the strong seal portion 42. . However, as described above, since the external force that peels and opens the weak seal portion 38> the external force that peels and opens the weak seal portion 28, the weak seal 28 that partitions the compartments 29 and 30 is peeled off at first. By continuing further pressurization, the weak seal 38 is peeled open. That is, the weak seal 38 is peeled and opened starting from the upper portion 38-3, which is a connecting portion to the outer bag 10, but the synthetic resin film pieces 12, 14 constituting the outer bag 10 by continuous pressurization from the outside. As a result of the expansion, the part 38-4 on the discharge control chamber 40 side is also peeled open. Therefore, all of the drug solution stored in the upper compartment 29, the drug solution stored in the lower compartment 30, and the drug stored in the inner bag 32 can be guided to the discharge port 18, and the drug is infused in an unmixed state. Eliminates the fear of

  2 and 3, the strong seal portion (external force applying portion of the present invention) 42 is provided along the upper portion 38-3 of the weak seal 38 (perpendicular to the plane of FIG. 2 and FIG. 3). direction). Ends 34-1 and 36-1 of the upper and lower synthetic resin films 34 and 36 constituting the inner bag 32 extend toward the compartment 30, and an extended end 34-1 toward the compartment 30 side. , 36-1 are tightly sealed on the inner surfaces of the upper and lower films 12 and 14 constituting the outer bag 10, so that the external force due to the expansion of the upper and lower films 12 and 14 constituting the outer bag 10 when the infusion bag is opened The inner surfaces of the upper and lower films 34 and 36 constituting the inner bag 32 are welded to each other through the upper and lower film end portions 34-1 and 36-1 constituting the inner bag 32 that expands following the upper and lower films 12 and 14. It is efficiently transmitted to the upper portion 38-3 of the weak seal portion 38, which is the portion, and it is possible to prompt the reliable opening of the weak seal portion 38 of the inner bag 32 using this as a base point for opening. 1, the weak seal portion 38 of the inner bag 32 is integrated with the strong seal portion 16 (the wide portion 16-1 in FIG. 1) in both the left and right side portions 38-1 and 38-2. Since the strong sealing portion 16 receives the force by which the inner bag 32 is pulled to the inner surface facing portion of the outer bag 10 when the inner bag 32 is applied to the weak sealing portion 38, the inner bag 32 is not pulled inward. Thus, the upper and lower side portions 38-3 and 38-4 of the weak seal portion 38 can be reliably opened, and the infusion solution can be guided to the discharge port 18 without any defects. Further, since the inner bag 32 is strongly sealed to the outer bag facing surface by the point seal portion 44 at the side portion 38-4 on the discharge control chamber 42 side, the opening of the inner bag 32 in the full width is promoted, and the infusion is reduced. Since the inner bag 32 can be guided to the discharge port 18 and is not pulled toward the discharge port separating side at the time of opening, it can also be used to maintain the posture of the inner bag 32 appropriately.

  8 and 9 show a second embodiment of the present invention. The difference from the first embodiment is that a weak seal portion 60 for welding the upper and lower film pieces 34 and 36 of the inner bag 32 so as to be peeled off (the present invention). The inner bag 32 is divided into left and right compartments 62 and 64 by the weak seal portion 60, and a separate auxiliary drug can be accommodated in each of the compartments 62 and 64. it can. Therefore, the weak seal portion 60 is also opened when the weak seal portion 38 on the outer periphery of the inner bag 32 is opened by the external force applying portion (strong seal portion 42) under pressure from the outside of the chemical solution in the outer bag 10, and the compartment 62, The medicine in 64 can be discharged toward the discharge port 18.

  FIG. 10 shows another embodiment, in which the lower end 10-1 (second compartment side) of the outer bag 10 is gradually narrowed toward the outlet 18. The inner bag 32 is located at the lower end 10-1 of the outer bag 10. The inner bag 32 has a weak seal portion 38 (sealing portion of the present invention) along the outer periphery, and the weak seal portion 38 includes left and right side portions 38-1, 38-2 and upper and lower side portions 38-3, 38-4. Consists of. The left right side portions 38-1 and 38-2 are inclined following the shape of the lower end 10-1 of the outer bag 10, but are welded to the upper and lower films constituting the wide portion 16-1 in the strong seal portion 16. The lower compartment 30 and the discharge control chamber 40 are isolated by the proximity side (upper side 38-3) of the weak seal portion 38 of the inner bag 32 to the compartment 30 and the portion 16-1 of the strong seal 16. It is the same that the second partition is formed. Further, the upper and lower film pieces of the outer bag 10 are strongly welded so as to overlap the upper side portion 38-3 of the weak seal portion 38 of the inner bag 32, thereby constituting a strong seal portion 42 which becomes an external force applying portion. It is the same. In this embodiment, the inside of the inner bag 32 is partitioned into upper and lower compartments 72 and 74 by a weak seal 60 as an inner container partition.

  FIG. 11 shows still another embodiment of the present invention. In the inner bag 32, both ends of the upper portion 38-3 of the weak seal portion 38 (sealing portion of the present invention) on the outer periphery are strong seals on the outer periphery of the outer bag 10. It terminates at a considerable distance from the left and right sides of the part 16. The lower ends of both side portions 38-1 and 38-2 of the weak seal portion 38 on the outer periphery of the inner bag 32 also terminate from the lower side portion of the strong seal portion 16 on the outer periphery of the outer bag 10. The inner bag 32 is strongly sealed to the opposing surface of the outer bag 10 along the upper portion 38-3 and both side portions 38-1, 38-2 of the weak seal portion 38, and this strong seal portion 42 is the external force applying portion of the present invention. As in the first embodiment, the weak seal portion 38 is peeled off by the external force applied to the outer bag 10 and the inner bag 32 is opened. The strong seal portion 42 extends beyond the lower ends of the upper portion 38-3 and both side portions 38-1, 38-2 of the weak seal portion 38 to the lower side of the strong seal portion 16 on the outer periphery of the outer bag 10. The extended portions 42-1 and 42-2 are provided (see also FIG. 13). The extending portions 42-1 and 42-2 weld the synthetic resin film facing portion constituting the outer bag. That is, in this embodiment, the upper portion 38-3 and the both side portions 38-1 and 38-2 of the weak seal portion 38 are on the side close to the lower compartment 30 in the weak seal portion 38. By providing the extension portions 42-1, 42-2, the lower compartment 30 and the discharge control chamber 40 are separated in a fluid-tight manner, that is, the extension portions 42-1, 42-2 of the strong seal portion 42 are provided in the inner container. The lower compartment 30 and the sealing part (38-1, 38-2 and 38-3) on the side close to the second compartment are connected to the opposite outer peripheral side part (strong seal part) 16 of the outer container at both ends. The connecting portion of the present invention is configured to connect the discharge control chamber 40 while being separated. In other words, the upper portion 38-3 and both side portions 38-1, 38-2 of the weak seal portion 38 and the extended portions 42-1, 42-2 of the strong seal 42 cooperate with each other to form the second space. A second partition wall of the present invention that separates the chamber 30 and the discharge control chamber 40 is configured. Further, the inner bag 32 is separated into compartments 72 and 74 each containing an auxiliary drug by a weak seal portion 60 (inner container compartment portion of the present invention) extending in the lateral direction (see also FIG. 12).

  FIG. 14 shows another embodiment, which has a lower end portion 10-1A in which the width of the outer bag 10 is narrowed. This is similar to the embodiment of FIG. 10, but the lower end portion 10-1A is shown in FIG. The inner bag 32 (the outline that overlaps with the strong seal portions 16 and 42 is indicated by a broken line) is accommodated in this portion 10-1. The inner bag 32 is provided with a sealing portion 38 (38-1, 38-2, 38-3 and 38-4), and is strong along the upper portion 38-3 adjacent to the lower compartment 30 in the sealing portion 38. The structure in which the seal portion 42 is fixed to the inner surface of the inner bag 32 (partitioned into upper and lower compartments 72, 74 by the weak seal portion 60) opposite to the inner surface of the outer bag 10 is different from that in FIG. 1 and other embodiments. There is no. Further, both ends of the upper portion 38-3 and the left and right side portions 38-2 of the sealing portion 38 are sandwiched between upper and lower film pieces constituting the outer bag 10 when the strong seal portion 16 on the outer periphery of the outer bag 10 is formed. There is no difference in the structure that is attached and obtains the flow-tight structure. In this embodiment, the strong seal portion 16 maintains the same width even in the fixing portion between the right and left side portions 38-2 of the sealing portion 38.

  In the embodiment of FIG. 14, the inner bag 32 is accommodated in the neck-shaped lower end portion 10-1A of the outer bag 10, and the inner bag 32 is downsized to facilitate dimensional accuracy. Further, the length of the upper and lower side portions 38-3 and 38-4 in the infusion flow direction in the sealing portion 38 is shortened, and stress at the time of opening is more concentrated, so that the inner bag 32 can be easily peeled and opened. It becomes.

  In the above-described embodiment, the strong seal portion 42 overlaps (subjects) or substantially overlaps with the lower compartment 30 in the sealing portion 38 of the inner bag 32 in the proximity side, that is, the upper portion 38-3. The structure is such that the strong sealing portion 42 does not cover the upper portion of the sealing portion 38 (the opposed welding portion in the strong sealing portion 42 is substantially only on the compartment 30 side). Hereinafter, this embodiment will be described with reference to FIG. 15. FIG. 5 is basically the same as FIG. 1, and the inner bag 32 is the outer bag. 10 is extended to the strong seal portion 16 on the outer periphery, and a fluid tight structure between the lower compartment 30 and the discharge chamber 40 is obtained. Unlike FIG. 1, the strong seal portion 16 does not include the wide portion 16-1, and both ends of the inner bag 32 are sandwiched and sealed between the upper films constituting the strong seal portion 16. As in FIG. 1, the sealing portion (weak seal portion) 38 includes left and right side portions 38-1, 38-2 and upper and lower upper and lower side portions 38-3, 38-4. The inner bag 32 is partitioned into left and right compartments 62 and 64 by a longitudinal weak seal portion 60. As in the other embodiments, the strong seal portion 42 as the external force imparting portion fixes the inner surface of the outer bag 10 to the opposing outer surface of the inner bag 32, but the strong seal portion 42 is closer to the compartment 30 than the sealing portion 38-3. The arrangement is such that both are hardly or not worn. That is, as shown in FIG. 16, strong welding between the upper and lower films 12 and 14 constituting the outer bag 10 and the upper and lower synthetic resin film pieces 34 and 36 constituting the inner bag 32 is substantially caused by the edge portions 34-1, It is done only in 36-1. The synthetic resin film pieces 12 and 14 constituting the outer bag 10 are not welded to the synthetic resin film pieces 34 and 36 constituting the inner bag 32 at the sealing portion 38-3.

  FIG. 17 is a cross-sectional view schematically showing the formation of the strong seal portion 42 by the seal mold in this embodiment in accordance with FIG. 7B, and the outer die 102, 104 is heated between the upper and lower dies 102, 104 heated to a predetermined temperature. The bag 30 and the inner bag 32 are sandwiched and the outer bag 10 is sandwiched between the film pieces 34 and 36 constituting the inner bag 32, and the extending end portion from the sealing portion 38-3 to the second compartment 32 Pressurization of 34-1, 36-1 is performed. The upper and lower dies 102 and 104 do not press the opposing surfaces of the outer bag 10 and the inner bag 32 on the sealing portion 38-3 side from the extended end portions 34-1 and 36-1. Accordingly, the extended end portions 34-1 and 36-1 are welded to the opposing surfaces of the upper and lower film pieces 12 and 14 constituting the outer bag 10 so as not to substantially cover the sealing portion 38-3. The opposing inner surfaces of the projecting ends 34-1 and 36-1 are not welded by the high melting temperature layers), and a strong seal portion 42 is formed as an external force applying portion (FIG. 16).

  Also in this embodiment, the external force due to the expansion between the film pieces 12 and 14 constituting the outer bag 10 at the time of opening is applied to the opening portion 38-3 via the edge portions 34-1 and 36-1 on the compartment side. Since it can transmit efficiently, reliable opening is realizable. Then, in comparison with the welded structure in which the strong seal portion 42 as the external force applying portion is overlapped with the opening portion 38-3, in the case of the structure in which the strong seal portion 42 is overlapped with the opening portion 38-3, FIG. As shown in 3 etc., the welded portion overlaps four places at the top and bottom, and the container tends to be hard at this portion, but in this embodiment, the strong seal portion 42 (thick solid line) and the unsealed portion 38-3 (thick broken line) ) Can be prevented from becoming too hard because the container does not overlap or substantially does not overlap.

  FIG. 18 is a modified embodiment of the embodiment of FIG. 8, and the sealing portion (weak seal portion) 38 of the inner bag 32 is composed of left and right side portions 38-1, 38-2 and upper and lower side portions 38-3, 38-. With four. However, the inner bag 32 is reduced in size and has a narrow left and right width, and the upper and lower side portions 38-3 and 38-4 do not reach the strong seal portions 16 on both the left and right sides. The strong seal portion 42 as an external force imparting portion strongly seals the inner surface of the outer bag 10 to the outer surface of the inner bag 32 at the upper portion 38-3 of the sealing portion 38. In the strong seal portion 42, portions 42A and 42B beyond the upper portion 38-3 of the seal portion 38 extend to the strong seal portions 16 on the left and right sides of the outer bag 10 and are integrally connected thereto. In the airtight separation (formation of the second partition wall of the present invention) between the compartment 30 and the discharge control chamber 40, the upper portion 38-3 of the sealing portion 38 of the inner bag 32 is in the strong seal portions 42 on both sides thereof. This is performed by extending to the strong seal portion 16 via the portions 42A and 42B where the upper and lower film pieces of the outer bag 10 are welded, and being integrally connected thereto. The portions 42A and 42B may be configured as weak seals that weld the opposing inner surfaces of the outer bag 10 in a peelable manner. The strong seal portion 42 as the external force imparting portion is configured to cover the upper portion 38-3 of the sealing portion 38 of the inner bag 32 in accordance with FIGS. 3 and 7, and the flow between the compartment 30 and the discharge control chamber 40. A tightly separated state can be ensured. That is, when the strong seal portion 42 has a structure that does not overlap the upper portion 38-3 of the sealing portion 38 of the inner bag 32 as shown in FIG. 16, the upper portion 38-3 of the sealing portion 38 of the inner bag 32 Since liquid leakage occurs at the connection portions of the strong seal portion 42 with the portions 42A and 42B and the function as the second partition wall of the present invention is lost, the seal portions 42 and 38-3 are ensured to ensure the function. It is necessary to overlap.

  FIG. 19 shows the multi-chamber container of the eighth embodiment, which is similar to the embodiment of FIG. 14, but the shape of the lower part of the chemical solution bag is somewhat different, and the inner bag is in the outer bag 10. There is also a difference in the form of the strong welded portion 16-1 of the outer bag 10 that fixes 32. That is, the strong welded portion 16-1 has a narrow tip 16-1A extending from the strong seal portion 16 on the outer periphery of the outer bag 10 toward the inner bag 32 to the upper corner (side of the compartment 30) of the inner bag 32. Established. And the connection part of the right-and-left both sides 38-1, 38-2 and upper side part 38-3 in the weak seal part 38 of the inner bag 32 is being fixed to the outer bag 10 by the strong welding part 16-1. The inner bag 32 is basically free from the outer bag 10 on the discharge port 18 side from the tip end portion 16-1A, but the inner bag 32 is disposed at both ends of the lower side portion 38-4, that is, is discharged. It fixes to the outer bag 10 by the point seal | sticker parts 44-1 and 44-2 so that the exit 18 may be pinched | interposed. That is, the upper and lower film surfaces of the outer bag 10 are strongly welded to the lower side portion 38-4 of the weak seal portion 38 of the inner bag 32 at the local sites indicated by 44-1 and 44-2. The embodiment of FIG. 14 and the inner bag 32 have a rectangular shape elongated in the width direction of the outer bag 10, and the inside thereof is partitioned into upper and lower compartments 72 and 74 by a weak seal portion 60 as an inner container partition portion. By installing the point seal portions 44-1, 44-2 on both sides, it becomes easier to widen the film constituting the opening 48-5 when the discharge port 18 described in FIGS. 6D and 6E is mounted. The discharge port 18 can be inserted into the predetermined position more easily and reliably.

Next, the manufacturing method of the inner bag 32 in the eighth embodiment will be described. In FIGS. 20 and 21, the tubular sheet material 80 constituting the inner bag 32 is wound around a roll R formed by inflation or the like. It is. Figure 22 is a cross-sectional shape of the film F which constitutes the sheet material 80 is shown schematically, cyclic polyolefin on one surface of the polyethylene substrate layer F ₁ made of multilayer polyethylene film (the inner surface and comprising a layer of inner bag 32) A resin (COP) layer F ₂ is formed, and a protective film F ₃ made of polyamide resin (nylon) is detachably attached to the other surface (the layer that becomes the outer surface of the inner bag 32). As shown in FIG. 20, driving units 82-1 and 82-2 for pulling out the sheet-like material 80 from the roll R are installed on the downstream side. The driving units 82-1 and 82-2 are provided with appropriate driving devices, and are configured to be able to control the intended pulling movement of the sheet-like material 80 from the roll R. In addition, the polyethylene base material layer F ₁ , the cyclic polyolefin resin (COP) layer F ₂ that forms the film F, and the polyamide resin layer F ₃ that serves as a protective film use a multiple melt extrusion nozzle when the material 80 is inflated. Although the polyamide resin layer F ₃ does not have enough affinity for the base material layer F ₁ to be integrated, inflation is performed while maintaining mutual adhesion (can be peeled off). For this reason, the polyamide resin layer F ₃ (protective film) is maintained in an adhesive state in the inner bag chain forming step described below for the tubular sheet-shaped material 80. The protective film F ₃ is not particularly limited as long as it has a low affinity with the polyethylene base layer, and polypropylene, ethylene vinyl alcohol copolymer, and the like can also be used.

FIG. 23 schematically shows a cross-sectional shape of the sheet-like material 80 immediately after being pulled out from the roll R. The sheet-like material 80 has a flat bag shape with both ends closed. 22 is a cyclic polyolefin resin (COP) layer F ₂ .

As shown in FIG. 20, a center seal device (mold) 86-1 and 86-2 are arranged between the guide rollers 84 and 85, and the sheet is temporarily stopped at the position of the molds 86-1 and 86-2. As for the material 78, the inner surfaces (the cyclic polyolefin resin (COP) layer F ₂ ) are peeled with a predetermined width at the center in the width direction by combining the sealing dies 86-1 and 86-2 as shown in FIG. Possible welding (weak seal). As shown in FIG. 21, the seal molds 86-1 and 86-2 are moved by the length of the heating surface when the seal molds 86-1 and 86-2 are opened, and the sealing process is repeated by combining the seal molds 86-1 and 86-2. The weak seal portion (center seal) 80A is formed over the entire length along the center line of the sheet-like material 78, and becomes the weak seal portion 60 of the pouch 38 in FIG. Weak seal temperature of the cyclic polyolefin resin (COP) layer F ₂ together to form a center seal 80A is already as 180 ° C. of about description in connection with the embodiment of FIG.

  A cutter 88 is disposed downstream of the guide roller 84-2, and both end edges in the width direction of the sheet-like material 80 are cut by the cutter 88, and the sheet-like material 80 has openings 80B on both sides thereof as shown in FIG. -1, 80B-2 is formed.

  In FIG. 20, downstream of the cutter 88, circular columnar liquid injection bodies 90-1 and 90-2 extending along the moving direction of the sheet-like material 80 (molding metal for imparting a convex shape to the sheet as will be described later) The liquid injection bodies 90-1 and 90-2 are arranged on the center seal 80A inside the sheet material 80 through the openings 80B-1 and 80B-2 of the sheet material 80 from both sides. The insertion position is along the line (see also FIG. 26 (a)). Liquid injection nozzles 92-1 and 92-2 are fitted and fixed to the liquid injection main bodies 90-1 and 90-2 having a cylindrical shape so as to extend over the entire length along the center line. The upper ends of the liquid injection nozzles 92-1 and 92-2 are connected to liquid medicine supply pipes 93-1 and 93-2 (FIG. 21), and the medicine supply pipes 93-1 and 93-2 are openings of the sheet-like material 80. The parts 80B-1 and 80B-2 are extended to the outside and connected to respective drug supply sources (tank, pump, etc.) not shown. Side seal molds 94-1 and 94-2 are arranged so as to sandwich the liquid injection main bodies 90-1 and 90-2 through the sheet material 80. As shown in FIG. 26 (a), the seal molds 94-1 and 94-2 are concave surfaces 94- 9 shaped so as to substantially follow the upper and lower halves of the liquid injection main bodies 90-1 and 90-2 in the cross section. 1A, 94-1B; 94-2A, 94-1B are formed. The concave surfaces 94-1A, 94-1B; 94-2A, 94-1B extend from the upper end surface to the lower end surface of the molds 94-1 and 94-2 as shown in FIG. As shown in FIG. 26, concave surfaces 94-1A, 94-1B in molds 94-1 and 94-2; both sides of 94-2A and 94-1B have flat surfaces 94-1C and 94-2C, The flat surfaces 94-1C and 94-2C seal both sides of the sheet-like material 80. As shown in FIG. 20, the seal molds 95-1 and 95- for the cross are positioned below the side seal molds 94-1 and 94-2 (positions where the lengths of one drug sealing portion are separated). 2 is arranged.

FIG. 26 (a) shows the open position of the seal molds 94-1, 94-2, and FIG. 26 (b) shows that the seal molds 94-1, 94-2 are combined from the position of FIG. 26 (a). The seal position is shown. The flat surfaces 94-1C and 94-2C are combined (left and right in FIG. 20) with the sheet material 80 interposed therebetween, whereby the side seals 80C-1 and 80C-2 (weakness of the inner bag 32 in FIG. 19) are combined. The upper and lower side portions 38-3 and 38-4 of the seal portion 38 are formed, and the seal molds 95-1 and 95-2 are combined (left and right in FIG. 20) to cross the sheet-like material 80. A seal 80D (becomes left and right side portions 38-1, 38-2 in the weak seal portion 38 of the inner bag 32 in FIG. 10) is formed. Also, the concave surfaces 94-1A, 94-1B; 94-2A, 94-1B of the molds 94-1 and 94-2 substantially follow the upper and lower halves of the outer diameters of the liquid injection bodies 90-1 and 90-2. Because of its shape, the sheet material 80 is sandwiched between the concave surfaces 94-1A, 94-1B; 94-2A, 94-1B and the outer diameter surfaces of the liquid injection main bodies 90-1, 90-2. In accordance with the curved shape of the concave surfaces 94-1A, 94-1B; 94-2A, 94-1B to receive heat at about 180 ° C., which is a weak sealing temperature between the cyclic polyolefin resin (COP) layers F ₂ Heat set. Therefore, the sheet-like material 80 has a concave surface 94-1A, 94-1B; 94-2A, 94-1B as shown in FIG. Cavities 80E-1 and 80E-2 having a length corresponding to the length of the sealing molds 94-1 and 94-2 are formed in accordance with the curved shape. The hollow portions 80E-1 and 80E-2 serve as upper and lower compartments 72 and 74 in the weak seal portion 38 of the inner bag 32 shown in FIG.

  Explaining the cooperation between the movement of the sheet-like material 80 by the driving units 82-1 and 82-2 and the sealing operation by the sealing molds 94-1, 94-2 and 95-1, 95-2 and the injection of the medicine, The movement of the sheet-like material 80 is stopped, and the sealing molds 94-1 and 94-2 are combined as shown in FIG. Side seals 80C-1 and 80C-2 are formed by 94-1D and 94-2D. Further, since the sheet material 80 is sandwiched between the concave surfaces 94-1A, 94-1B; 94-2A, 94-1B and the outer diameter surfaces of the liquid injection main bodies 90-1, 90-2, Heat-set to a convex shape that conforms to the curved shape. Further, the seal molds 95-1 and 95-2 are combined at a position downstream of the seal molds 94-1 and 94-2 by the length of one drug sealing part, and a cross seal 80D is formed. The sealing molds 94-1, 94-2 and 95-1, 95-2 are divided into left and right as shown in FIG. At this time, the cross seal 80D is connected to the cavity portions 80E-1 and 80E-2 newly defined by the union of the present sealing molds 95-1 and 95-2. The bottoms of the cavities 80E-1 and 80E-2 defined by merging of -1,95-2 are closed. The connected cavities 80E-1 and 80E-2 are still open on the top side, and the lower ends 92-1A and 92-2A of the injection nozzles 92-1 and 92-2 are cavities whose upper ends are still open. Portions 80E-1 and 80E-2 are opened (FIG. 21). Then, the medicines 96-1 and 96-2 are supplied to the lower ends of the injection nozzles 92-1 and 92-2 from the respective medicine supply sources (pumps, etc.) into the cavities 80E-1 and 80E-2 whose upper ends are still open. A predetermined amount is injected from 92-1A and 92-2A. Then, the sealing molds 94-1, 94-2 and 95-1, 95-2 are combined again to form a cross seal 80D by combining the sealing molds 95-1, 95-2. Seal 80D closes the tops of cavities 80E-1 and 80E-2 defined by the merger of the previous sealing molds 95-1 and 95-2 after the injection of the chemicals 96-1 and 96-2 has been completed. In addition, a single medicine sealing portion is formed that is sealed at the bottom, side, and the entire circumference of the top. On the other hand, new side seals 80C-1 and 80C are obtained by combining the sealing molds 94-1 and 94-2. -2 are formed, and new cavities 80E-1 and 80E-2 are formed which are open at the top. Thereafter, the same operation is repeated to form a plurality of inner bags 32 of the multi-chamber container shown in FIG. The chain M (hereinafter referred to as the inner bag chain) of the drug filling portion is configured.

As shown in FIG. 23, the inner bag chain M is transferred to the multi-chamber container manufacturing facility in which the protective film F ₃ is adhered to the front and back surfaces and the steps of FIGS. 5 and 6 are performed in this state. The The protective film F ₃ can be secured foreign matter adhesion prevention and sterility of the inner bag chain body M in the transfer process moderate. Then, when the multi-chamber container manufacturing process of FIG. 5 is performed, the protective film F ₃ in the inner bag chain M is peeled, and then the cross seal 80D is cut in the middle so that the inner bag 32 is completely separated. The step of inserting the inner bag 32 can be performed as described in 5 (b).

10. Outer bag (outer container of the present invention)
12, 14 ... Film piece 16 constituting outer bag ... Strong seal part
16-1 ... Wide part of strong seal part 16 (connecting part of the present invention)
18 ... discharge port 20 ... mixed injection port 28 ... weak seal portion (first partition wall of the present invention)
32 ... Inner bag (inner container of the present invention)
34, 36 ... Film pieces constituting the inner bag
34-1, 36-1 ... edge 38 ... weak seal on the outer periphery of the inner bag
38-1, 38-2 ... Left and right side of weak seal
38-3, 38-4 ... Upper and lower side portions 40 of the weak seal portion ... Discharge control chamber 42 ... Strong seal portion (external force applying portion of the present invention)
42 '... edge welded portion 44 ... point seal portion (auxiliary external force applying portion of the present invention)
80 ... Sheet-like material 80A ... Center seal
80B-1, 80B-2… Opening
80C -1, 80C-2 ... Side seal 80D ... Cross seal
80E-1, 80E-2 ... Cavity
82-1, 82-2 ... Drive unit
86-1, 86-2 ... Center sealing mold 88 ... Cutter
90-1, 90-2 ... Injection body
92-1, 92-2 ... Injection nozzle
93-1, 93-2 ... Drug injection tube
94-1, 94-2 ... Seal mold for side
95-1, 95-2 ... Cross seal mold

Claims (13)

An outer container formed in a bag shape from a flexible film, an outer container fixed to the outer periphery of the outer container, and an outlet for discharging the medicine, and the inside of the outer container is partitioned on the side away from the outlet; A first partition that can be opened by an external force to the outer container, and a first partition that can be opened by an external force that is greater than the external force that partitions the inside of the outer container on the side close to the discharge port and opens the first partition. 2 partition walls, a first compartment that is formed inside the outer container on the side away from the discharge port of the first partition wall, and stores the first liquid medicine, and the outside between the first partition wall and the second partition wall A second compartment which is formed inside the container and accommodates the second liquid medicine; and a discharge control chamber which is formed inside the outer container between the second compartment and the outlet and communicates with the outlet. Formed from a flexible film, and an outlet of the second compartment An inner container disposed inside the discharge control chamber on the contact side, containing an auxiliary drug, and having a sealing portion configured to be openable along the outer periphery; and an inner side along the second compartment and the proximity side An outer force applying part that fixes the container to the opposing inner surface of the outer container and applies an external force for opening the sealing part of the inner container, and the second partition wall and the external force applying part are against the first partition wall. is shortened in length, the inner container is extended along the second partition wall, and the inner container is made by combining the fixed shape of the cross section convex at the opposing portions of the flexible fill arm, auxiliary A multi-chamber container comprising a hollow portion as an auxiliary medicine housing chamber containing a medicine.

2. The multi-chamber container according to claim 1, wherein the auxiliary drug storage chamber is installed over substantially the entire length of the second partition wall. 3. The multi-chamber container according to claim 1 or 2, wherein a plurality of auxiliary drug storage compartments are installed in parallel. 4. The multi-chamber container according to claim 2, wherein the second partition wall and the external force imparting portion are extended over substantially the entire width of the discharge control chamber. The invention according to any one of claims 1 to 4 , wherein the second partition wall includes a sealing portion on a side close to the second compartment of the inner container, and a second compartment of the inner container. A multi-chamber container comprising a sealing part on the near side of the container and a connecting part for connecting the second compartment and the discharge control chamber to the opposing part of the outer container at both ends. 6. The multi-chamber container according to claim 5 , wherein the connecting part is an outer container strong seal part welded integrally with a sealing part of the inner container. 7. The multi-chamber container according to claim 5 or 6 , wherein the external force imparting portion is disposed along the sealing portion on the side close to the second compartment of the inner container.   8. The multi-chamber container according to claim 7, wherein the fixing portion of the inner container in the external force imparting portion to the inner surface facing the outer container extends somewhat toward the second compartment from the sealing portion of the inner container. .   9. The multi-chamber container according to claim 8, wherein a portion of the inner container fixed to the opposing inner surface of the outer container is not substantially covered with the sealing portion of the inner container. In the invention according to any one of claims 1 to 9 , an auxiliary external force imparting portion that locally fixes the side of the sealing portion of the inner container that is separated from the second compartment to the opposing surface of the outer container. Multi-chamber container equipped. 11. The multi-chamber container according to claim 10 , wherein a pair of the auxiliary external force applying portions are provided with a discharge port interposed therebetween. The invention according to any one of claims 1 to 11 , wherein the inner container is formed as a sealable portion that can be opened by welding the flexible film pieces so as to be peeled from each other, while the inner container The multi-chamber container which became an external force provision part by welding an outer surface to the inner surface of the outer container facing this so that it cannot peel. The invention according to claim 12 , wherein the flexible film constituting the inner container has a multilayer structure including a layer made of a resin having a low melting temperature and a layer made of a resin having a high melting temperature. The sealing part of the container is configured by welding the opposing surfaces of the high melting temperature layer in the opposing flexible film pieces, and the external force applying part is the opposing surface of the low melting temperature layer in the flexible film pieces to the outer container. A multi-chamber container constructed by welding with.

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