JP4500974B2 - Method of manufacturing flexible container for medical solution filling - Google Patents

Description

[0001]
BACKGROUND OF THE INVENTION
In the present invention, a chemical solution storage chamber is disposed between resin films, the resin film around each chemical solution storage chamber is liquid-tightly sealed by a strong seal portion, and a cylindrical shape is used for pouring the chemical solution from the chemical solution storage chamber. BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical container containing a medical chemical solution in which a port member is disposed in a medical solution storage chamber, a medical solution bag in which a medical chemical solution is enclosed in a flexible container, and a method for manufacturing the same. The enclosed medical medicinal solution is preferably an infusion supplied to the human body by infusion
[0002]
[Prior art]
Conventionally, an infusion for supplying nutrients to a human body by drip is typically contained in a resin-made flexible container having a port member. The port member has a rubber stopper that can be pierced by a hollow needle, and at the time of administration, an infusion solution is poured out from the container through the hollow needle that has been pierced by the rubber stopper, and is sent into an infusion tube that communicates with the hollow needle. . In addition, a container (double bag) is known in which a container is partitioned into a first chamber and a second chamber by a weak seal portion that can be easily peeled, and different chemical solutions are accommodated in each chamber. For example, Japanese Patent Application Laid-Open No. 7-178151 or Japanese Patent Publication No. 6-26563 divides a container made of a flexible resin into a first chamber and a second chamber by an easily peelable weak seal portion, and a fat emulsion in the first chamber. And an amino acid, a sugar and an electrolyte in a second chamber, and a weak seal portion is pressed from outside during administration to separate the solutions in both chambers.
[0003]
Japanese Patent No. 2890143 discloses a multi-chamber container provided with a medical multilayer film and a weak seal. The multilayer film is composed of three layers mainly composed of polyolefin, and the inner layer in contact with the chemical solution and the outer layer in contact with the outside air are both ethylene / α-olefin copolymer having a density of 0.930 to 0.945 g / cm 3, It is made of a mixed resin with polypropylene. The intermediate layer has a mixing ratio (weight) of an ethylene / α-olefin copolymer having a density of 0.920 to 0.945 g / cm 3 and an ethylene / α-olefin elastomer having a density of 0.880 to 0.890 g / cm 3. Ratio) is 1: 5 to 2: 1. This patent discloses a method for producing a large number of multi-chamber containers from a tubular multilayer film obtained by inflation molding. In this manufacturing method, first, the peripheral material of many multi-chamber containers is welded at 155 to 185 ° C. to form a strong seal part, and the vicinity of the center of each container is welded at 105 to 150 ° C. to form a weak seal part. Form. Next, the container material is cut and a port member is attached. Japanese Examined Patent Publication No. 7-88065 discloses a molded sealing device for a container having a spout that allows filling and discharging of liquid or powder. The apparatus of this publication includes a container main body forming part, a container main body delivery apparatus, a spout alignment supply part, and a spout seal part. The container main body molding unit includes a film supply device that supplies the film as it is long, a film transport device that transports the film supplied from the device, a main body seal device that welds the film with an appropriate width during transport, A total punching device for punching around the welded portion of the film is included.
[0004]
Japanese Patent Application Laid-Open No. 10-194213 discloses a method for producing a soft bag used for filling a liquid or the like. In this manufacturing method, an opening for inserting the filling nozzle into the film is formed by incising the side edge of the film while feeding out the tubular film, and the incised side of the film that has passed through the position of the filling nozzle After the edge is fused with a vertical heat sealer, the film is filled into the film from the filling nozzle, and the film at the position to be the upper end of the soft bag and the lower end of the next soft bag is fused with the horizontal heat sealer. . The tubular film is sterilized at the time of molding, immediately folded into a flat shape and wound into a roll, and the inside is in a sterile state without being exposed to the outside air. In JP-A-7-156918, in order to continuously form a bag while pulling out a plastic film, the sealed portions of the overlapped plastic film were heated and melted with an anti-adhesive tape interposed between the upper and lower sides. After that, a heat sealing device for cooling and solidifying to seal is disclosed. In this apparatus, the heat-melting heater device and the cooling and solidifying cooling device are sequentially moved to the sealing portion of the plastic film and heat-sealed.
[0005]
[Problems to be solved by the invention]
A first object of the present invention is to eliminate the process of mounting a port member after filling a flexible container with a chemical solution, thereby eliminating the complexity of the filling machine and simplifying the sealing process of the container after the chemical solution is filled. It is an object of the present invention to provide a flexible container that eliminates the need to match the production speed and the filling machine speed, and a method for producing the same. Another object of the present invention is to provide a large number of continuous flexible films in which a large number of chemical solution storage chambers are formed in the longitudinal direction of the belt-shaped resin film material and a port member having a large thickness is attached to the side edge of the film material. It is an object of the present invention to provide a flexible container in which the container is a roll that is easy to store and convenient for sequential supply to a filling machine, and a method for manufacturing the flexible container. Another object of the present invention is to provide a flexible container including a weak seal portion having a uniform peel strength, which is manufactured from a tubular film material manufactured by inflation molding, and a method for manufacturing the same.
[0006]
Still another object of the present invention is to provide a chemical solution to the chemical solution storage chamber on one side of the cutting line, in which adjacent chemical solution storage chambers arranged in the elongated film material are cut and separated in the lateral direction by one straight cutting line. To provide a flexible container in which a filling port can be formed at the same time, and a method for manufacturing the same. Still another object of the present invention is to provide a flexible container including a chemical liquid filling port that can be easily opened by cutting an edge of a chemical liquid storage chamber, and a manufacturing method thereof. Other objects of the present invention will be clarified in the following description.
[0013]
[Means for Solving the Problems]
In the present invention, the chemical solution storage chamber is disposed between the resin film materials, and the resin film material around the chemical solution storage chamber is liquid-tightly sealed by the strong seal portion, and the port member for pouring the chemical solution from the chemical solution storage chamber The method of manufacturing a flexible container for encapsulating medical medicinal solution placed in the medicinal solution containing chamber is a step of preparing a film material in which both side edges in the longitudinal direction of two resin films are connected to each other. Forming a strong seal in the film material such that the chamber is disposed in the longitudinal direction of the film material, the central axis of the port member being substantially perpendicular to the longitudinal direction of the film material and across the longitudinal side edges of the film material; Attaching the port member to the film material, and winding the film material having the port member around an axis perpendicular to the longitudinal direction of the film material to form a roll. Separating the flexible containers individually by cutting between two chemical storage chambers adjacent to each other in the longitudinal direction of the film material by a substantially straight cutting line extending substantially perpendicular to the longitudinal direction. The adjacent strong seal portions around the two chemical liquid storage chambers adjacent to each other in the longitudinal direction of the film material include a transverse seal portion extending in a direction perpendicular to the longitudinal direction of the film material, and the transverse seal portion is the longitudinal direction of the film material. Including a large portion having a large width dimension and a small narrow portion in the direction, and the cutting line passes through the filling port forming portion and the large portion adjacent to the small width portion, and the cutting line passing through the filling port forming portion causes the chemical solution to enter the chemical solution enclosure compartment. Forming the inlet.
[0014]
The manufacturing method of the present invention can include one or more of the following features. (1) The roll is wound sparsely in the vicinity of both side edges in the vicinity of the center between both side edges in the longitudinal direction of the film material, and the port member wound in the vicinity of the outer side of the roll is outside the roll in the radial direction. The port member near the inside of the roll is inclined radially inward of the roll. (2) The step of forming the roll includes the step of winding the film material around a reel having a large diameter portion near the center of both side edges of the film material and having a small diameter portion near both side edges. (3) The step of forming the strong seal portion on the film material includes the step of heat-welding the film material, and the step of cooling the heat-welded film material before forming the weak seal portion. (4) The film material in which both side edges in the longitudinal direction of two resin films are connected is a flattened tube-shaped single layer or multilayer film obtained by inflation molding. (5) The flexible container for medical drug solution enclosure includes a weak seal portion arranged to divide the chemical solution storage chamber into two or more enclosure compartments, and the weak seal portion is manually attached to the chemical solution filled in the enclosure compartment. By applying pressure, the sealing section can be easily peeled off and the sealed section can be communicated, and the manufacturing method further includes the step of forming a weak seal portion on the film material by heat welding.
[0015]
(6) The weak seal portion is formed so as to extend in the longitudinal direction of the film material.
The step of preparing a film material in which both side edges in the longitudinal direction of two resin film materials are connected is the step of preparing two strip-shaped resin flat films and the two side edges in the longitudinal direction of two flat films are bonded. Forming a film material. (7) The step of bonding both side edges in the longitudinal direction of two flat films to form a film material and the step of forming a strong seal portion on the film material are simultaneously performed by heat welding. (8) The step of arranging a plurality of flexible containers continuously in the longitudinal direction of the film material to form a strong seal portion is adjacent to the two chemical liquid storage chambers adjacent to each other in the longitudinal direction of the film material. Forming a strong seal portion simultaneously. (9) The port member is one in which one end of a resin conduit is communicated with the chemical solution storage chamber, and the other end is sealed with a stopper that can be pierced by an injection needle. Mounting the port member such that the axis of the conduit is substantially perpendicular to the longitudinal direction. (10) The step of attaching the port member is a step of opening a part of the side edge of the film material to form a port insertion portion, one end of the resin conduit is communicated with the chemical solution storage chamber, and the other end is outside the chemical solution storage chamber. Placing the conduit into the port insert, and bonding and sealing the outer peripheral surface of the conduit and the film material near the port insert.
[0016]
(11) The cutting line has a cut surface that obliquely intersects the surface of the film material.
[0017]
BEST MODE FOR CARRYING OUT THE INVENTION
Embodiments of the present invention will be described below with reference to the drawings. FIG. 1 (a) is a plan view of a flexible container (double bag) having two enclosures made by the manufacturing method of the present invention, and FIGS. 1 (b) and 1 (c) are views of FIG. 1 (a). It is sectional drawing which follows line AA and line BB. FIG. 2 is a plan view showing a film material in which a strong seal portion and a weak seal portion are formed in the manufacturing process of the flexible container of FIG. 1 (a), (b), and (c), a flexible container 2 for encapsulating medical medicinal solution includes a medicinal solution containing chamber 21 and a medicinal solution containing chamber 21 arranged between two overlapping resin films 10. Weak seal part 34 divided into two enclosure chambers 18, 19, strong seal part 24 for liquid-tight sealing between the resin films around the chemical solution storage chamber 21, a chemical solution is poured out from the chemical solution storage chamber 21, or a chemical solution storage chamber A port member 40 is provided which allows the medicinal solution to be injected.
[0018]
The flexible container 2 includes a weak seal portion 34 that divides the chemical solution storage chamber 21 into two enclosure compartments 18 and 19, and the weak seal portion 34 manually applies pressure to the chemical solution contained in the enclosure compartment via a film material. By adding, it can peel easily and can make the adjacent enclosure divisions 18 and 19 communicate. The container 2 is provided with a through hole 29 so that the container can be suspended when using the chemical solution contained in the container. The port members 40, 40 are configured such that one end 44 of a resin-made cylindrical conduit 41 communicates with the chemical solution storage chamber 21 and the other end 43 is sealed with a stopper 42 that can be pierced by a hollow needle. It is possible to pour out the chemical solution from the chemical solution storage chamber 21 or inject the chemical solution into the chemical solution storage chamber via the pierced hollow needle. The port member 40 adjacent to the upper through hole 29 in FIG. 1 is used for injecting a chemical solution such as minerals, vitamins, etc., and the port member 40 far from the lower through hole 29 in FIG. Used for pouring.
[0019]
FIG. 2 is a plan view showing the film material 10 in a state where the strong seal portion 24 and the weak seal portion 34 are formed on the two-layered strip-shaped resin film material 10 during the manufacturing process of the flexible container 2 of FIG. is there. The two-layer belt-shaped resin film material 10 can be a resin film material 10 in which a tubular single-layer or multilayer resin film 9 obtained by the inflation molding shown in FIG. . In this case, since the side edges 12 and 13 of the resin film material 10 are provided with a connection structure, it is advantageous in that no germs or foreign matters are mixed into the film material. However, the strip-shaped resin film material 10 may be formed into a flat tube shape by laminating two flat films of single layer or multilayer and welding the side edges with a heat sealer.
[0020]
In FIG. 2, a plurality of chemical solution storage chambers 21 are formed along the longitudinal direction of the strip-shaped resin film material 10, that is, the X direction. Each chemical solution storage chamber 21 is divided into two sealed compartments 18 and 19 by a weak seal portion 34 extending in the X direction. The weak seal portion 34 is formed substantially parallel to the X direction of the film material. The weak seal portion 34 substantially parallel to the X direction is suitable for forming a weak seal portion having a stable strength when a tubular resin film material obtained by inflation molding is used. This is because the thickness of a tubular resin film formed by inflation molding is relatively uniform in the longitudinal direction (direction parallel to the cylindrical axis), but tends to be not uniform in the circumferential direction. This is because if a weak seal is formed in the direction, the peel strength tends to vary.
[0021]
Each of the chemical solution storage chambers 21 and 21 is separated and separated from each other by a substantially straight cutting line C extending in the Y direction between two chemical solution storage chambers 21 and 21 adjacent in the X direction of the film material. It is possible to make the container 2 or 2. The adjacent strong seal portions 24 of the two chemical solution storage chambers 21, 21 adjacent in the X direction of the film material include a lateral seal portion 25 extending in the Y direction, and the lateral seal portion 25 is a large portion 26 having a large size in the X direction. And a narrow portion 27 having a small dimension in the X direction. The cutting line C is extended through the filling port forming part 22 and the large part 26 adjacent to the narrow part 27. Filling ports 22 ′ and 22 ′ of the chemical liquid into the chemical liquid enclosure sections 18 and 19 are opened by the cutting line C passing through the filling port forming unit 22. In order to prevent germs and foreign substances from entering the container 2, the cutting with the cutting line C is preferably performed immediately before the chemical solution is filled into the chemical solution storage chamber.
[0022]
As shown in FIG. 2, the two-layered strip-shaped resin film material 10 includes a port insertion portion 23 for mounting the port member 40. The port insertion portion 23 is arranged in a direction perpendicular to the longitudinal direction of the film material 10 (Y direction) and across the side edges 12 and 13 of the film material. The film material 10 is attached with the port member 40 after the strong seal portion 24 and the weak seal portion 34 are formed. In the example of FIG. 2, the port insertion portion 23 is composed of a non-adhesive portion that reaches the side edge 12 or 13 formed between the strong seal portions 24, and the port insertion is performed by cutting the vicinity of the side edge of the non-adhesive portion. The part 23 is opened. By inserting the inner end portion 44 of the resin conduit 41 of the port member 40 into the opened port insertion portion 23, the outer peripheral surface of the conduit 41 and the film material surface of the port insertion portion 23 are thermally welded and sealed. A port member 40 communicating with the respective enclosure chambers 18 and 19 of the chemical solution storage chamber 21 at the inner end 44 is attached to the container. Each port member 40 is disposed substantially along the Y direction of the film material 10 and across the side edges 12, 13 of the film material. By this process, the continuous several chemical | medical solution storage chamber 21 formed on a film material is completely sealed, and miscellaneous bacteria and a foreign material do not enter from the exterior.
[0023]
FIG. 4 is a plan view of a film material provided with continuous chemical solution storage chambers 21 and 21 which are substantially the same as those in FIG. In the film material of FIG. 4, each container 2, 2, 2 is separated by a process of simply cutting between two adjacent chemical solution storage chambers 21 by a cutting line C, and at the same time, a chemical solution filling port is provided in each enclosure compartment 18, 19 respectively. 22 'and 22' are opened. The opening of the chemical liquid filling ports 22 ′ and 22 ′ is preferably performed immediately before the chemical liquid filling step. The film material formed with a plurality of continuous chemical solution storage chambers 21 and 21 is wound around an axis perpendicular to the longitudinal direction into a roll 50 shown in FIG. 9 for convenience of storage or transport.
[0024]
FIG. 5 is a schematic view showing a process of winding the film material 10 after the port member 40 is attached. As shown in FIG. 5, the film material 10 is wound around a reel 51. The reel 51 has a large diameter portion 52 in the vicinity of the central portion 11 of both side edges of the film material, and a small diameter portion 53 in the vicinity of both side edges. As shown in FIG. 9, the roll 50 is tightly wound in the vicinity of the central portion 11 between the two side edges in the longitudinal direction of the film material 10, and the port member 40 radially outward of the roll 50 is rolled into the roll 50. The port member 40 radially inward of the roll 50 is inclined radially inward of the roll 50.
[0025]
FIG. 6A is a cross-sectional view showing a cut state of the film materials 10 and 10 ′ for opening the filling port 22 ′ for filling the filling chamber with the chemical solution, and FIG. It is sectional drawing which shows the inclination of the cross section of other resin film 10, 10 '. The film material for opening the filling port is preferably cut by a cutting line C by the same mold as the cutting between two adjacent chemical solution storage chambers 21. It can also be set as the cutting process different from the cutting process for isolate | separating. In the step of cutting the resin film for opening the filling port, the cutter blade 56 is preferably inclined with respect to the film plane so that the cut surface 36 forms an acute angle α (30 to 80 °) with respect to the film plane. Disconnected. Since the cut surface 36 is inclined with respect to the film plane, it becomes easy to separate and open the overlapped films 10 to form a filling port. In particular, when the thickness of the resin film is 100 μm or more, the inclination of the cut surface facilitates the separation and opening of the film.
[0026]
FIG. 7 is a plan view of a flexible container 3 (single bag) having a single chemical solution storage chamber 21 obtained by the manufacturing method of the present invention. Similar to the container 2 described above, the container 3 includes a port member 40 for dispensing a chemical solution, a strong seal portion 24 for sealing the periphery of the chemical solution storage chamber 21 and a container 3 for suspending the container 3 during use. A through hole 29 is provided. FIG. 8 is a plan view of the film material 10 in the process of making the strong seal 24 of the container 3 of FIG. In the film material 10 shown in FIG. 8, two rows of chemical solution storage chambers 21 are arranged in the longitudinal direction (X direction) of the film material, and the film material around each chemical solution storage chamber 21 is thermally welded to form a strong seal 24. Indicates the state. The through hole 29 of each container is disposed in the vicinity of the central portion 11 of the film material 10.
[0027]
Each chemical solution storage chamber 21 is provided with a port insertion portion 23 for attaching one port member in the vicinity of both side edges 12 or 13 of the film material. 2 and 4, the port member is attached by cutting and opening the vicinity of the side edge of the film material provided with the port insertion portion 23, inserting the conduit of the port member, and the outer peripheral surface of the conduit and the film. This is accomplished by thermally welding and sealing between the material surfaces. When a port member is attached to the film material 10 of FIG. 8, a film material similar to that of FIG. 4 is obtained in which the port members are arranged side by side along both side edges of the film material 10.
[0028]
For the convenience of storage or transport, the container 3 formed in succession on the film material 10 of FIG. 8 is wound around an axis perpendicular to the longitudinal direction, as in the case of the film material 10 of FIG. 9 to form the roll 50 shown in FIG. FIG. 9 is a schematic cross-sectional view in a plane including the axis M of the roll 50 of the flexible container. Similar to the film material 10 of FIG. 4, the film material 10 is wound around a reel 51 as shown in FIGS. 5 and 9. The reel 51 has a large diameter portion 52 in the vicinity of the central portion 11 of both side edges of the film material, and a small diameter portion 53 in the vicinity of both side edges. As shown in FIG. 9, the roll 50 is wound sparsely in the vicinity of both side edges in the vicinity of the central portion 11 between the two side edges in the longitudinal direction of the film material 10, The port member 40 is inclined radially outward of the roll 50, and the port member 40 radially inward of the roll 50 is inclined radially inward of the roll 50. The roll 50 is rewound immediately before filling with the chemical solution, and the drug storage chambers 21 and 21 in the form of FIG. 8 are cut and separated, and the filling port forming portions 22 and 22 of each drug storage chamber are cut and the chemical solution filling port is cut. Is opened.
[0029]
FIG. 10 is a block diagram schematically showing the method for manufacturing the flexible container of the present invention.
The first film supply step 60 includes a step of preparing a film material in which two layers of resin films are connected at both side edges in the longitudinal direction. As the film material, a tube-shaped single layer or multilayer film obtained by inflation molding is fed out through a film transporter. The second peripheral portion sealing step 62 includes a step of forming a strong seal portion at the periphery of the film material by leaving a large number of chemical solution storage chambers and port insertion portions in the longitudinal direction of the film material by a heat sealing machine. Since the film material after the second peripheral edge sealing step 62 is hot due to the heat of heat welding, a cooling step 63 is placed. In the case of manufacturing a two-chamber container including a plurality of enclosure compartments and a weak seal, a weak seal forming step 64 is placed simultaneously with or separately from the second step. When using the blown film, it is possible to eliminate uneven peel strength due to variation in the thickness in the circumferential direction by forming a weak seal portion along the longitudinal direction of the film material.
[0030]
In the third port member mounting step 65, the port member is inserted into the port insertion portion of the film material so that the axis of the resin conduit of the port member is substantially perpendicular to the longitudinal direction of the film material and crosses the side edge in the longitudinal direction of the film material. Including the step of attaching. By this third step 65, the chemical solution storage chamber is completely sealed, so that germs and foreign substances do not enter from the outside. The fourth film winding process 66 includes a process of winding a film material, which is manufactured by the first to third processes and includes a plurality of port members along both side edges, onto a reel. The winding of the film material is such that the central portion of the film material is dense and the side edges are sparse so as to allow the presence of the port member. Nearby ones are inclined radially inward, and ones outside the roll are inclined radially outward. Since the film material is in the form of a roll and is small, it is convenient for storage (step 67) and transportation.
[0031]
In the fifth cutting / filling port forming step 68, the filling port forming portion of the rewound film material is cut to form a filling port for filling the chemical solution, and the strong seal portion around the chemical solution storage chamber is punched out. Separating the container. The formation of the filling port is performed so that the cut surface is acute with respect to the film plane in order to easily open a space between two layers of film material. In particular, when the thickness of the resin film is 100 μm or more, the inclination of the cut surface facilitates the separation and opening of the film. The sixth chemical liquid filling step 70 includes a step of opening a chemical liquid filling port formed by cutting the film material filling port forming portion and filling the chemical liquid storage chamber through the chemical liquid filling nozzle. The seventh filling port sealing step 72 includes a step of welding the resin film material around the chemical solution filling port of the chemical solution storage chamber filled with the chemical solution and sealing the container.
[0032]
【The invention's effect】
In the present invention, the chemical solution storage chambers constituting the plurality of containers are arranged along the longitudinal direction of the strip-shaped resin film material, and the port member is substantially perpendicular to the longitudinal direction of the film material and has side edges in the longitudinal direction of the film material. Placed across, the film material is wound into a roll around an axis perpendicular to the longitudinal direction. This roll-shaped container is easy to store and transport because the chemical solution storage chamber is completely sealed with respect to the outside and no germs or foreign matter enter. Moreover, it can be set as the flexible container which accommodates a medical chemical | medical solution by a simple and short process of rewinding and cutting. Accordingly, after the container is manufactured, the chemical solution filling process can be performed after the container is stored for a necessary time while being kept clean or moved to a different place. In this roll, all the port members are arranged near the side edges of the film material, and are densely wound near the center between the two side edges in the longitudinal direction of the port member film material, and loosely wound at both ends. Is done. The port member outside the roll is inclined outwardly of the roll, and the port member inside the roll is inclined outwardly of the roll. Therefore, regardless of the presence of the port member, the roll is relatively small and does not deform in shape, which is convenient for storage and movement.
[0033]
In the present invention, the resin film material is a tube-shaped single-layer or multi-layer resin film obtained by inflation molding, and the weak seal portion that divides the chemical solution storage chamber into two or more sealed compartments is provided in the longitudinal direction of the film material. Are formed substantially parallel to each other, thereby eliminating unevenness in the strength of the weak seal portion due to variations in the thickness of the film in the circumferential direction. The filling port forming portion for forming the chemical solution filling port is cut so as to have a cut surface that obliquely intersects the surface of the film material, particularly in the case of a thick film material of 100 microns or more, the chemical solution filling step It is extremely easy to open the filling port of the chemical solution at.
[0034]
In the present invention, the strong seal portion includes a transverse seal portion extending in a direction perpendicular to the longitudinal direction of the film material, and the transverse seal portion is a large portion having a large width dimension of the transverse seal portion that coincides with the longitudinal direction of the film material. And the cutting line extends through the filling port forming portion and the large portion adjacent to the narrow width portion, and the cutting line passing through the filling port forming portion forms a filling port for the chemical solution into the chemical solution enclosure compartment. By doing so, it is possible to cut and separate adjacent containers and cut the filling port with a straight cutting line. Also, the opening of the chemical solution filling port is formed by cutting the filling port forming part which is a part of the resin film, and after the chemical solution is filled into the chemical solution storage chamber through the filling port, the filling port welds the surrounding film material Therefore, the chemical solution filling process is simple and can be performed in a short time, and the possibility that various bacteria and foreign substances enter the chemical solution storage chamber in the filling process is minimal.
[0035]
In the present invention, a plurality of chemical solution storage chambers are arranged in a line in the longitudinal direction of the film material, and each chemical solution storage chamber is divided into two sealed compartments by a weak seal portion extending in the longitudinal direction of the film material, Are arranged on both side edges in the longitudinal direction of the film material, and one port member is arranged in one enclosing compartment, so that all the port members of the plurality of double bags are arranged on the side edges of the film material, and A plurality of single backs are arranged in two rows along the longitudinal direction of the film material, and all the port members are arranged on both side edges in the longitudinal direction of the film material. , Port members are disposed at both ends, and the rolls are densely wound at both ends densely at the center of the roll, so that a compact roll having a small shape can be obtained.
[Brief description of the drawings]
FIG. 1 (a) is a plan view of a flexible container (double bag) in which a chemical solution storage chamber made by the manufacturing method of the present invention is partitioned into two enclosing chambers by a weak seal, FIG. (b), (c) is sectional drawing which follows the line AA and line BB of Fig.1 (a).
2 is a plan view showing a film material in which a strong seal portion and a weak seal portion are formed in the manufacturing process of the flexible container of FIG. 1; FIG.
FIG. 3 is a schematic view showing a step of crushing and flattening a tubular resin tube obtained by inflation molding into a thin and long film material.
4 is a plan view of the film material after the port member is attached in the manufacturing process of the flexible container of FIG. 1 at a stage where a continuous flexible container is cut off to form a filling port for a chemical solution. FIG.
FIG. 5 is a schematic view showing a state in which the film material is wound after the port member is attached.
FIG. 6A is a schematic cross-sectional view showing a cut state for forming a filling port. FIG.6 (b) is sectional drawing which shows the inclination of the cut surface of the cut | disconnected resin film.
FIG. 7 is a plan view of a flexible container (single bag) having a single enclosure chamber made by the manufacturing method of the present invention.
FIG. 8 is a plan view of a film material at the stage of making a strong seal of a flexible container (single bag).
FIG. 9 is a schematic cross-sectional view in a plane including the roll center axis of the flexible container.
FIG. 10 is a block diagram showing a method of manufacturing a chemical solution bag using the present invention.
2; Double bag, 3; Single bag, 9; Tubular film material, 10, 10 '; Film material (resin film), 11; Central part, 12, 13; Side edge, 18, 19; Enclosing compartment, 21; Storage chamber, 22; filling port forming portion, 22 '; filling port, 23; port insertion portion, 24; strong seal portion, 25; lateral seal portion, 26; large portion, 27; narrow portion, 29; Weak seal part 36; cutting surface 40; port member 41; conduit 42; plug 43; outer end 44; inner end 45; axis 50; roll 51; reel 52 Large diameter portion, 53; small diameter portion, 56; cutter blade, α; angle, C: cutting line, M: axis, X: longitudinal direction of the film material.

Claims (7)

A chemical solution storage chamber is arranged between the resin film materials, and the resin film material around the chemical solution storage chamber is liquid-tightly sealed by the strong seal portion, and the port member is used for pouring the chemical solution from the chemical solution storage chamber. A method for producing a flexible container for encapsulating a medical chemical solution disposed in a step of preparing a film material in which both side edges in the longitudinal direction of two resin films are connected to each other, and a plurality of chemical solution storage chambers are provided. Forming a strong seal in the film material so as to be disposed in the longitudinal direction of the film material, such that the central axis of the port member is substantially perpendicular to the longitudinal direction of the film material and crosses the longitudinal side edges of the film material; Attaching the port member to the film material; and wrapping the film material having the port member attached about an axis perpendicular to the longitudinal direction of the film material to form a roll.
Separating the flexible containers individually by cutting between two chemical liquid storage chambers adjacent to each other in the longitudinal direction of the film material by a substantially straight cutting line extending substantially perpendicular to the longitudinal direction, The adjacent strong seal portions around the two chemical solution storage chambers adjacent to each other in the longitudinal direction include a transverse seal portion extending in a direction perpendicular to the longitudinal direction of the film material, and the transverse seal portion has a width in the longitudinal direction of the film material. The cutting line includes a large portion having a large size and a small width portion, and the cutting line passes through the filling port forming portion and the large portion adjacent to the small width portion, and the cutting line passing through the filling port forming portion is used to feed the chemical liquid into the liquid medicine enclosure. The manufacturing method characterized by including the step of forming. Forming a strong seal portion to the film material, the film material comprises the step of heat welding, prior to forming the weak seal process of claim 1 including the step of cooling the heat welded film materials. The manufacturing method according to claim 1 or 2 , wherein the film material in which both side edges in the longitudinal direction of the two resin films are connected is obtained by flattening a tube-shaped single layer or multilayer film obtained by inflation molding. The flexible container for encapsulating medical medicinal liquid includes a weak seal portion arranged to divide the medicinal liquid storage chamber into two or more enclosing compartments, and the weak seal portion is manually pressed against the medicinal solution filled in the enclosing compartment. are those that can communicate easily peeled sealed compartments by adding the manufacturing method further comprises a step of forming by thermal welding the weak seal part in the film material, any one of claims 1 to 3 Manufacturing method. The manufacturing method according to claim 4 , wherein the weak seal portion is formed so as to extend in a longitudinal direction of the film material. The port member is one in which one end of a resin conduit is communicated with a chemical solution storage chamber and the other end is sealed with a stopper that can be pierced by an injection needle, and the step of attaching the port member is the longitudinal direction of the film material. Mounting the port member such that the axis of the conduit is substantially perpendicular to the direction, the mounting of the port member opening a portion of the side edge of the film material to form a port insert; The conduit is placed in the port insertion portion so that one end of the conduit is in communication with the chemical solution storage chamber and the other end is outside the chemical solution storage chamber, and the outer peripheral surface of the conduit and the film material in the vicinity of the port insertion portion are bonded and sealed. The manufacturing method of any one of Claims 1 thru | or 5 including the step to perform. The manufacturing method according to any one of claims 1 to 6 , wherein the cutting line has a cutting surface that obliquely intersects the surface of the film material.

Images