JPWO2007055355A1 - Multi-chamber container - Google Patents

Abstract

The medicine storage bag 10 is formed of a soft synthetic resin film-like material, and its internal cavity is partitioned into a plurality of compartments 20 and 22 by a weak seal portion 18, and the discharge port 12 is opened so as to open into the one compartment 20. Is provided. A small-capacity sealing bag 13 is disposed inside the medicine storage bag 10, and the sealing bag 13 seals the open end of the discharge port 12 to the internal cavity of the medicine storage bag 10. As the synthetic resin film constituting the sealing bag 13, a material more fragile than that of the synthetic resin film constituting the medicine storage bag 10 is selected. The inner surface of the medicine storage bag 10 and the inner surface of the sealing bag 13 are firmly welded at a rectangular small area with a sharp corner shape. The inner bag is ruptured and opened by the expansion of the outer bag due to the fluid pressure when the weak seal portion is opened.

Description

  In the present invention, the internal cavity is separated by the weak seal portion, thereby forming a plurality of compartments each separately containing and storing the drug, and the drug is mixed by opening the weak seal portion during use, The present invention relates to a multi-chamber container to be discharged.

There are multi-liquid mixing type multi-chamber containers for infusion and dialysis. In a multi-chamber container, the internal cavity of a medicine storage bag made of a soft film is separated into a plurality of compartments for storing different chemical solutions by weak seal portions. On the outer periphery of the medicine storage bag, there is provided a chemical solution discharge port as a rigid plastic molded product capable of maintaining its shape, the chemical solution discharge port is formed in a cylindrical shape, and the internal cavity is one compartment on one end side The other end is provided with a rubber plug. Prior to administration of the drug solution to the patient, the weak seal portion is opened by pressurizing the drug storage bag from the outside, and the internal cavity of the drug storage bag becomes a single chamber, so the two types of drug solutions are mixed, and the infusion set A rubber stopper is punctured with a puncture needle, and a drug solution can be administered from a drug storage bag. Therefore, in this type of multi-chamber container, it is essential to open both of the weak seals by opening the weak seal prior to the administration of the chemicals, while on the other hand, the chemicals can be drained without opening the weak seals. When the rubber stopper was punctured at the outlet, there was a possibility of an erroneous operation in which only the drug solution in the compartment on the drug solution outlet side was administered. As a conventional technique for coping with this problem, in addition to the first weak seal portion that separates the internal cavity of the medicine storage bag into two compartments, a second weak seal portion is provided immediately before the chemical solution outlet, By making the second second weak seal portion equal to or higher than the pressure required to open the first weak seal portion, the first weak seal portion and then the second weak seal portion are opened in this order. Thus, there has been proposed a method in which discharge is performed after mixing of chemicals (see Patent Document 1).
JP-A-9-327498

  In the technique of Patent Document 1, in addition to the first weak seal portion that separates the two compartments, a second weak seal portion is provided immediately before the chemical solution discharge port, and these weak seal portions are sequentially opened so that they are not mixed. However, since the two weak seals are provided, the manufacturing process is complicated, and it is very difficult to accurately manufacture a plurality of weak seals with different strengths. The cost is high, the cost is increased, and the user is forced to perform a two-stage pressurization work, which is not necessarily good workability. In addition, depending on the method of pressurizing the medicine storage bag, the opening is not always performed in the order of the first weak seal portion → the second weak seal portion, and the second weak seal portion on the side of the chemical solution discharge port is the first. If it is opened, there is a possibility of shifting to the administration work as it is, and in this case, only one solution is administered without mixing.

  The present invention has been made in view of the above problems, and provides a novel structure of a multi-chamber container that cannot be administered in an unopened state, is low in manufacturing cost, and has a user-side workability. The object is to more surely eliminate the possibility of an erroneous operation in which administration is performed in an unmixed state despite being good.

  The mixed-type drug-sealed bag-like material according to the present invention has a drug storage bag formed of a flexible film, a discharge port for discharging the drug, and an internal cavity of the drug storage bag. And a weak seal portion that is opened by a pressing force applied from the outside to the medicine storage bag and mixes the medicines stored in the respective compartments. The sealing bag formed of a flexible film that is more fragile than the flexible film constituting the medicine storage bag and located inside the medicine storage bag is the compartment of the medicine storage bag into the internal cavity of the medicine storage bag. The outlet is surrounded and disposed so as to close the opening end of the medicine bag, and the inner surface of the medicine storage bag is welded and joined to the opposing outer surface of the sealing bag at a small area to form an opening portion, and the pressing force at the time of opening By opening the medicine storage bag by the above, the sealing bag is broken at the opening portion, the discharge port is opened in the internal cavity of the drug storage bag, and the mixed medicine is discharged from the discharge port. By making the opening portion an acute angle portion, stress concentration is caused, and the sealing bag can be surely ruptured by the fluid pressure generated by opening the weak seal portion.

  The discharge port is normally closed by a sealing bag inside the medicine storage bag, and the sealing bag is firmly welded and joined to the opposite surface of the medicine storage bag at an opening portion as a small area portion. Therefore, by appropriately selecting the material and thickness of the synthetic resin film constituting the sealing bag, the size of the opening portion, the shape of the opening portion, etc., the internal fluid pressure during the mixing operation can reliably destroy only the sealing bag. The mixed drug can be discharged from the discharge port. By making the isolation seal (weak seal) with which the two liquids should be mixed and the opening part that prevents the administration of the mixed drug into an opening structure with a separate mechanism, it is possible to perform reliable "stepwise" communication. is there.

FIG. 1 is a plan view of the multi-chamber container of the present invention (viewed in the direction of arrow I in FIG. 2). FIG. 2 is a sectional view of the multi-chamber container of the present invention, and is a view taken along the line II-II in FIG. FIG. 3 is a partial view of the vicinity of the discharge port in FIG. 2, and schematically shows a state when the multi-chamber container of the present invention is opened. FIG. 4 is a schematic view showing an example of the point seal method in a series of steps. FIG. 5 is a schematic view showing another example of the point seal method in a series of steps. FIG. 6 shows a discharge port with an internal bag mounted with a point seal support plate. FIG. 7 is a perspective view schematically showing a state where the point seal support plate is attached to the discharge port in FIG. FIG. 8 is a partial view of the vicinity of the discharge port of the multi-chamber container in another embodiment in which the opposing surfaces of the medicine storage bag 10 and the inner bag 13 are connected by a heat seal part of substantially full width in addition to the point seal.

Explanation of symbols

10 ... Drug storage bag 12 ... Discharge port 13 ... Sealing bag 18 ... Weak seal part
20, 22 ... compartment 30 ... small area (point seal)
50 ... Point seal plate

  1 to 2, the multi-chamber container includes a flat medicine storage bag (external bag) 10 for storing medicine, a discharge port 12 fixed to the outer periphery of the medicine storage bag 10, and a medicine storage bag 10. And a small-capacity sealing bag (inner bag) 13 that seals the outlet 12 in a normal state. The medicine storage bag 10 is made of a soft film (flexible material of the present invention) having a multilayer structure such as a polypropylene film or a polyethylene film having a thickness of 200 microns. The two pieces of synthetic resin film are sealed at the outer periphery by a strong seal portion 14 formed by being pressed at a high temperature (120 ° C. in the case of polypropylene) sufficiently higher than the softening temperature. It has a rectangular bag shape. The medicine storage bag 10 may be a bag made from a tubular inflation film or a container formed by blow molding, in addition to the bag made from the film as described above. A suspension hole 16 is formed in the strong seal portion 14, and the medicine storage bag 10 is suspended and held by the suspension hole 16 on an infusion stand or the like to perform infusion or dialysis.

  A weak seal portion (peelable weld portion) 18 extends over the entire width of the intermediate portion in the length direction of the medicine storage bag 10, and the front and back opposing inner surfaces of the medicine storage bag 10 are welded by the weak seal portion 18. The internal cavity is divided into a first compartment 20 and a second compartment 22. The first compartment 20 is filled with the first chemical solution, and the second compartment 22 is filled with the second chemical solution. The weak seal portion 18 is formed by pressurizing the front and back surfaces of the synthetic resin film section forming the medicine storage bag 10 at a low temperature (110 ° C. in the case of polypropylene) slightly higher than its softening temperature. Therefore, the strong seal portion 14 is left as it is by pressurizing the drug solution in the drug storage bag 10 from the outside in the compartments 20 and 22 with the respective drug solutions stored in the first compartment 20 and the second compartment 22. In addition, the weak seal portion 18 can be broken and opened by fluid pressure (pressure of the chemical at the time of pressurization) to mix the first chemical and the second chemical.

  The discharge port 12 is formed of a synthetic resin having a thickness and rigidity capable of maintaining the form (preferably made of the same plastic material as the drug storage bag 10 in order to obtain adhesion to the drug storage bag 10). It is a product. The discharge port 12 is open at both ends, and is formed in a cylindrical shape having a tapered portion 12-1 at the middle and a flange portion 12-2 (FIG. 1) at the upper end. A cap 12-3 is abutted and welded to the flange portion 12-2, and a rubber inner lid 12-4 (a plug of the present invention) is attached to the bottom opening of the cap 12-3. At the time of infusion such as infusion, the inner lid 12-4 is punctured by the puncture needle of the infusion set, and the inner cavity of the medicine storage bag 10 is communicated with the infusion tube to perform infusion. In this embodiment, the synthetic resin film forming the front and back surfaces of the medicine storage bag 10 is heated and adhered while sandwiching the cylindrical portion of the discharge port 12 from above and below via the synthetic resin film forming the front and back surfaces of the sealing bag 13. Thus, the medicine storage bag 10 is sealed with respect to the discharge port 12.

  As shown in FIGS. 1 and 2, the small-capacity sealing bag 13 is provided inside the medicine storage bag 10 and is provided to seal the discharge port 12 in a normal state. The sealing bag 13 is similar to the medicine storage bag 10 in that the two upper and lower synthetic resin film sections such as polypropylene film and polyethylene film are heated at the outer peripheral portion 13A (the welding temperature of the strong seal portion 14 of the medicine storage bag 10). It is formed by welding at the same temperature), but as described later, it is sealed so that it can be ruptured at the point seal portion by opening the medicine storage bag 10 due to fluid pressure when the weak seal 18 is opened. The synthetic resin film constituting the bag 13 is suitably weaker than the synthetic resin film constituting the drug storage bag 10 in terms of strength. On the other hand, from the viewpoint of thermocompression bonding at the time of point sealing, the inner and outer bags are preferably made of the same synthetic resin material, and the thickness of the synthetic resin film constituting the sealing bag 13 in order to have a desired difference in strength. Can be appropriately made thinner than that of the synthetic resin film constituting the medicine storage bag 10. Alternatively, the required strength difference between the inner and outer bags can be reduced by means such as making the polymerization degree of the synthetic resin constituting the medicine storage bag 10 smaller than the polymerization degree of the synthetic resin constituting the sealing bag 13 or using a copolymer. It can be made to have. In addition, the sealing bag 13 is sterilized under sterilization (humidification) in the sealing bag 13 by making a minute hole through which a liquid having a flow rate very slow compared to the drip rate can pass. It is advantageous for operation. For this reason, by making the point seal portion into a perforated shape, it is possible to drill at the same time as the point seal. In FIG. 2, the bags 10 and 13 are drawn with a considerable thickness. However, this is for the convenience of drawing, and it should be noted that the thickness is drawn with a considerable exaggeration.

  As shown in FIG. 1, the sealing bag 13 has a width slightly larger than the outer diameter of the discharge port 12, extends toward the internal cavity of the medicine storage bag 10, and when the medicine storage bag 10 is not opened ( When the discharge port 12 is closed with respect to the internal cavity of the drug storage bag 10 when the compartments 20 and 22 are separated by the weak seal portion 18, the drug solution is discharged from the discharge port 12 without being mixed. Stop. When the medicine storage bag 10 is pressed to open the weak seal portion 18 for mixing medicines in the compartments 20 and 22, and preferably in the compartment 20 on the side away from the discharge port 12, the medicine storage bag 10 The opening of the medicine storage bag 10 due to the shocking chemical liquid flow (arrow F in FIG. 3) generated inside causes the sealing bag 13 to break, and the internal cavity of the medicine storage bag 10 storing the medicine is at the discharge port 12. The communication is made possible, and the mixed chemical solution can be discharged from the discharge port 12. In this embodiment, the sealing bag 13 is attached to the discharge port 12 together with the medicine storage bag 10 as described later. That is, the strong seal portion 14 on the outer periphery of the medicine storage bag 10 is welded to the outer periphery of the discharge port 12 at the portion 14-1, but the outer peripheral portion 13-1 of the sealing bag 13 is also overlapped and welded at the time of this welding. (See FIG. 2). On the other hand, the sealing bag 13 is normally closed with respect to the internal cavity (compartment 22) of the medicine storage bag 10, that is, when the weak seal portion 18 is not opened, the medicine in the medicine storage bag 10 is closed. Blocking toward the outlet 12. The outer surface of the sealing bag 13 is welded (point-sealed) to the opposing inner surface (upper and lower inner surfaces) of the medicine storage bag 10 with a small area portion 30. This small area portion 30 that welds the outer surface of the sealing bag 13 to the opposite inner surface of the medicine storage bag 10 has a rectangular shape with sharp corners as shown by the hatched area in FIG. The high temperature is equivalent to the welding temperature of the strong seal portion 14 on the outer periphery of the medicine storage bag 10. When the weak seal portion 18 is opened, the medicine storage bag 10 is expanded, and the sealing bag 13 whose outer surface is welded to the opposite inner surface of the medicine storage bag 10 with a small area portion 30 receives a tensile force in the vertical direction and is small. Since the welding of the area portion 30 is strong, a tearing force is generated in the sealing bag 13, and the synthetic resin film constituting the sealing bag 13 is weaker than the synthetic resin film constituting the drug storage bag 10 and There is also an effect of stress concentration caused by the sharp shape of the small area portion 30, the sealing bag 13 is strongly pulled by the point seal portion 30 by the expansion of the medicine storage bag 10, and the sealing bag 13 is The point seal portion 30 is ruptured, the discharge port 12 is opened, and the chemical solution can be discharged. That is, in order to open the medicine storage bag 10, the medicine storage bag 10 is placed flat on a desk or the like as shown in FIG. 2, and the medicine storage bag 10 is pressurized with a palm from the top as shown by an arrow b ( As shown in FIG. 3, it is preferable to pressurize the medicine storage bag 10 on the side of the compartment 20, but the side of the compartment 22 may be pressurized or both sides may be pressurized). The liquid pressure is applied to the weak seal portion 18 by pressurization of the medicine storage bag 10, and the weak seal portion 18 is instantaneously broken and opened by a predetermined pressure. The internal pressure of the medicine storage bag 10 is increased by the pressurization, and this increased pressure is released at once by opening and closing the weak seal portion 18, so a shocking flow of the chemical solution is caused in the medicine storage bag 10. Is done. In FIG. 3, the shocking flow of the chemical liquid that is caused in the medicine storage bag 10 is schematically indicated by an arrow F. The rapid flow F of the drug solution induced in the medicine storage bag 10 when the weak seal portion 18 is opened causes the medicine storage bag 10 to greatly expand as shown in FIG. Therefore, a large tearing force is generated in the small-capacity sealing bag 13 firmly welded to the opposite surface of the medicine storage bag 10 by the small area portion 30, and the synthetic resin film constituting the sealing bag 13 is a drug. Since the tear strength is weaker than that of the synthetic resin film constituting the storage bag 10, it can be ruptured. In FIG. 3, the point seal portion of the sealing bag 30 is torn while being welded to the medicine storage bag 10 as indicated by 13 ′. As a result, an opening 40 is formed in the sealing bag 13, and the medicine is opened as indicated by an arrow 40. In this state, the mixture can be discharged by puncturing the rubber plug 12-3 with a puncture needle of an infusion set (not shown). . In this way, in the present invention, the opening of the isolation seal (weak seal 18) to be mixed with the two liquids and the opening of the opening portion (point seal 30) for preventing the administration of the mixed medicine are said to be “stepwise”. "Because of the opening structure, it is possible to achieve reliable communication during opening work.

  The acute rectangular shape of the small area portion 30 can contribute to more reliably causing the sealing bag 13 to rupture due to the stress concentration effect. Then, by optimally setting the composition and thickness of the synthetic resin film constituting the sealing bag 13, the inflow of the drug into the discharge port 12 when the drug storage bag is not opened (when the weak seal portion 18 is closed) While reliably preventing (maintaining the closed state of the discharge port 12 by the sealing bag 13), the medicine is discharged by the reliable rupture of the inner bag 13 when the medicine storage bag is opened (when the weak seal portion 18 is opened). Can be made possible.

  An example of the process of forming the multi-chamber container of the present invention by sealing the medicine storage bag 10 will be described with reference to FIG. 4. The upper and lower synthetic resin films forming the medicine storage bag 10 are the strong sealing portions 14 on the outer periphery as shown in FIG. Is not welded at the site 14A, and an opening is present at this site. The sealing bag 13 is already accommodated in the medicine storage bag 10, and the outer peripheral portion 13A is temporarily welded to the inside of the opening portion 14A of the external bag leaving an opening in the mounting portion 13B of the discharge port 12.

  Next, a receiving tool for the welding tool is inserted toward the unsealed opening 13B of the sealing bag 13, and point sealing is performed with the external welding tool. That is, the welding tool having a welded part shape conforming to the shape of the point seal part and the receiver are brought into contact with each other via the film slice constituting the medicine storage bag 10 and the film slice constituting the sealing bag 13. Point sealing (high temperature welding at the small area portion 30) between the inner surface of the storage bag 10 and the outer surface of the sealing bag 13 is performed.

  Then, the discharge port 12 is inserted toward the unwelded opening of the sealing bag 13 as indicated by the arrow f in (b), and welding is performed from the outside of the medicine storage bag 10. Therefore, the unsealed portion 14A of the synthetic resin film section constituting the medicine storage bag 10 is thermocompression bonded to the outer periphery of the discharge port 12 through the unsealed portion of the synthetic resin film constituting the sealing bag 13, The sealing bag 10 is welded to the discharge port 12 via the sealing bag 13.

  (C) shows a state after the discharge port 12 is welded. In this state, the weak seal portion 18 shown in FIG. 1 is welded and the compartments 20 and 22 are filled with chemicals and the filling port is sealed. The multi-chamber container of the invention is completed.

  FIG. 5 shows a point seal method according to another embodiment. As shown in FIG. 5A, a discharge bag 12 having a sealed bag 13 already welded is prepared first. The medicine storage bag 10 has an unwelded portion 14A left on the outer peripheral strong seal portion 14, and this unwelded portion forms an opening, and the sealing bag 13 is connected to the medicine storage bag through the unsealed opening. 10 (FIG. 5B). And the unwelded part 14B is welded with respect to the discharge port 12, and the strong seal part 14 in the perimeter is completed. Then, as shown in (c), point sealing is performed, and the medicine storage bag 10 and the sealing bag 13 are welded at a rectangular small area portion 30 on the opposing surface. In this case, the point seal is such that the welding tool is disposed so as to sandwich the medicine storage bag 10 and the inner sealing bag 13 from the outside, and the welding tool is pressure-bonded via the inner and outer bags, thereby the inner surface of the medicine storage bag 10. And the outer surface of the medicine storage bag 10 are welded in a small area.

  In order to improve the weldability of the point seal in the embodiment of FIG. 5, the discharge port 12 having a point seal receiving plate 50 protruding into the internal cavity of the sealing bag 13 as shown in FIG. 6 is used. be able to. As shown in FIG. 7, the point seal tool receiving plate 50 includes a substrate portion 50-1 somewhat wider than the inner diameter of the discharge port 12 and a receiving plate portion 50-2 orthogonal to the substrate portion 50-1. 50-1 is press-fitted and fixed to a groove 52 formed at a diameter-opposing position on the inner diameter portion of the discharge port 12. The point seal device receiving plate 50 is made of a material that hardly adheres to the synthetic resin film constituting the bag inside and outside. The point seal is performed so that the medicine storage bag 10 and the inner bag 13 are sandwiched by the welding tool from the outside via the receiving plate portion 50-2. Therefore, it is possible to efficiently perform point sealing in a small area portion between the opposed surfaces of the inner surface of the medicine storage bag 10 and the outer surface of the inner sealing bag 13, and a sufficient flow path for the medicine is ensured because a gap remains. be able to.

  In the embodiment described above, the opposing surfaces of the medicine storage bag 10 and the inner bag 13 are connected only by the point seal, but as shown in FIG. The opposing surfaces of the medicine storage bag 10 and the inner bag 13 can be connected by a heat seal portion (high temperature weld portion = additional seal portion of the present invention) 42 of substantially the full width of the bag 13. Since the heat seal part 42 is wide, stress concentration as strong as the point seal 30 does not occur. Therefore, even if the inner bag 13 is torn at the portion of the point seal 30 when the medicine storage bag 10 is expanded due to the rapid flow of the chemical solution when the weak seal portion is opened, the heat seal portion 42 is not torn or hardly torn. Since the bag 13 remains joined to the medicine storage bag 10 as a whole, that is, the bag 13 is maintained in an inflated bag shape and only the portion of the point seal 30 is opened, the point seal 30 is broken from the internal cavity of the medicine storage bag 10. A smooth flow of the chemical liquid toward the discharge port 12 through the inner bag 13 can be ensured through the opening formed in this way.

  In addition, as described with reference to FIG. 2, the medicine storage bag 10 and the inner bag 13 are joined by the pair of point seals 30 on the opposing surfaces on the upper and lower sides, but the medicine storage bag 10 and the inner bag 13 are opposed to each other. The point seal 30 that joins the surfaces is provided only on one of the upper and lower surfaces in FIG. 2, and the other facing surface is joined at a heat seal portion that covers substantially the entire width where stress concentration is unlikely to occur. It may be. In this case, when the weak seal is opened for drug mixing, the drug storage bag 10 is opened only by rupturing and opening only the point seal on one side, and the other heat seal part is not ruptured, and the drug storage bag 10 and the inner bag 13 are opened. Since the opposite surface remains bonded, the inner bag 13 is not easily crushed similarly to FIG. 8, so that a smooth flow of the chemical liquid through the opening formed by the tear at the point seal portion is ensured as well. can do.

Claims (5)

  A medicine storage bag formed of a flexible film, a discharge port attached to the medicine storage bag for discharging the medicine, and the inside of the medicine storage bag are divided into a plurality of compartments for storing each medicine. A weak seal portion that welds the opposite inner surfaces of the drug storage bag so that the drug storage bag is peeled open by a pressing force applied from the outside to mix the drugs stored in the respective compartments, and a drug storage bag A sealing bag that is formed of a flexible film that is more fragile than the flexible film that is configured, and that surrounds and closes the opening end of the discharge port into the medicine storage bag, and is located inside the medicine storage bag; And an opening part formed by welding and bonding in a small area, and the sealing bag is broken at the opening part by opening the medicine storage bag by the pressing force at the time of opening. The opening that communicates the discharge port with the cavity inside the drug storage bag is sealed Multiple chambers formed.   The multi-chamber container according to claim 1, wherein the opening portion has a shape having an acute angle portion.   3. The multi-chamber container according to claim 1 or 2, wherein the discharge port includes a welder receiving plate that extends into the sealing bag so as to face the opening portion.   The invention according to any one of claims 1 to 3, further comprising an additional seal portion that welds and joins the facing surfaces of the medicine storage bag and the sealing bag in addition to the opening portion. The target seal portion is a multi-chamber container that maintains the expanded shape of the sealing bag when the sealing bag is broken.   A medicine storage bag formed of a flexible film, a discharge port attached to the medicine storage bag for discharging the drug, a stopper provided in the discharge port, and the inside of the drug storage bag store each drug. The inner surface of the medicine storage bag is welded so that the medicine storage bag is separated and opened by a pressing force applied from the outside to mix the medicine stored in each compartment. A multi-chamber container having a weak seal portion that performs the infusion operation, wherein the discharge port is formed of a flexible film that is weaker than the flexible film constituting the drug storage bag, and stores the drug. A sealing bag that surrounds and closes the open end of the discharge port inside the medicine storage bag is provided inside the bag, and the opposite surfaces of the medicine storage bag and the sealing bag are joined together. Make sure that the inside of the storage bag is substantially closed with respect to the outlet. The medicine in the first and second compartments is mixed by peeling the weak seal portion with the fluid pressure caused by pressurizing the medicine storage bag from the outside and communicating the plurality of compartments. The sealing bag is broken by opening the medicine storage bag caused by the peeling of the seal portion so that the mixed medicine is guided to the discharge port, and the infusion work is started by puncturing the infusion device into the stopper. Infusion method.

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