JP5223244B2 - Multi-chamber container - Google Patents

Description

  In this invention, the closing member provided in the discharge port is broken by an external force caused by the joint portion by the expansion of the medicine bag by the pressing force when the medicine bag is opened.

As a multi-chamber container for infusion, a plurality of partitions each containing different drug solutions by a partition wall (weak seal portion) formed by welding opposed surfaces of a drug bag made of a flexible or soft film at a relatively low temperature. Some rooms are separated. A discharge port as a plastic molded product is provided on the outer periphery of the drug bag, the discharge port is formed in a cylindrical shape, and the internal cavity opens to one compartment on one end side, but the other end has a rubber A stopper is provided. Prior to administration of the drug solution to the patient, the septum is peeled open by pressurizing the drug bag from the outside, and the inner cavity of the drug bag becomes a single chamber, so the two types of drug solution are mixed, and the puncture needle of the infusion set A rubber stopper is punctured to allow administration of a drug solution from a drug bag. Therefore, in this type of medical mixed-type multi-chamber container, it is indispensable to mix both liquids by opening the partition prior to administration of the chemical solution. On the other hand, the rubber plug at the discharge port is left without opening the partition. When the puncture is performed, there is a possibility of an erroneous operation in which only the drug solution in the compartment on the discharge port side is administered. As a conventional technique for dealing with this problem, the end face of the discharge port with respect to the drug bag is configured to be ruptured, and a stress applying part integrally extending from the breakable part is firmly welded to the opposite surface of the drug solution bag, There is one in which the end face of the discharge port is broken by expanding the stress applying portion by the swelling deformation of the chemical solution bag when the compartment is opened, and the discharge port is opened inside the chemical solution bag (Patent Document 1).
JP 2006-87904 A

  Patent Document 1 applies stress to the discharge port end surface from the stress applying portion by expanding the stress applying portion that is integrally extended from the end surface of the discharge port by the swelling deformation of the chemical bag when the partition wall is opened. Thus, the discharge port end face (breakable portion) is destroyed, and the discharge port is opened to the chemical bag. However, in the patent document, the discharge port end face (breakable portion) is an integrally formed portion with the discharge port, and there is a possibility that the breakable portion may not be surely broken by the force applied from the stress applying portion when the partition wall is opened. It was. In this case, although the partition wall was opened, the discharge port remained closed, and it was not possible to proceed directly to the infusion work.

  The present invention has been made in view of the above problems, and an object of the present invention is to reliably open the discharge port when the partition wall is opened.

The multi-chamber container of the present invention is formed of a flexible film, and the drug bag and the opposite surface of the drug bag can be pressure-separated to separate the internal cavity into a plurality of compartments for storing each drug. And a discharge port provided in the drug bag, and a sealing member that normally substantially seals the exhaust port. The sealing member is formed of a fragile material such as a foam material, and normally seals the discharge port substantially against the inside of the drug bag. Here, “substantial sealing” means that a small amount of drug can be allowed to pass, and even if the drug passes, even if the infusion is inadvertently started without the septum being opened, the amount of infusion is small and abnormal. This means that the flow rate to the extent that the worker is aware of and prompts the opening of the compartment is allowed. The sealing member is fixed to the discharge port by being inserted or cast into the discharge port, and is firmly connected to the opposite surface of the drug bag at the end in the drug bag. An outward force is applied, the sealing member formed of the fragile material is broken, the discharge port is opened inside the drug bag, and the drug from the drug bag can be guided to the discharge port. The brittle material that is the base of the sealing member is a foamed synthetic resin thermoformed product, and the sealing member that is a foamed synthetic resin thermoformed product has a cylindrical shape with the closed end as the one end inside the drug bag. The outer peripheral surface of the tip and the facing surface of the sealing member constitute the joint.

  Since the sealing member is made of a fragile material such as a foam material, it can be reliably opened by breaking due to an external force applied when the drug bag is opened, and an infusion is performed without being opened. Work can be prevented.

  1 to 2, the multi-chamber container of the present invention includes a flat drug bag 10 for storing a drug and a discharge port 12 fixed to the outer periphery of the drug bag 10. The drug bag 10 is made of a flexible film having a multilayer structure such as a polyethylene film having a thickness of 200 microns (the flexible material of the present invention). The two pieces of synthetic resin film are sealed at the outer periphery by a strong seal portion 14 formed by pressing at a high temperature sufficiently higher than the softening temperature (about 130 ° C. in the case of polyethylene). It has a rectangular bag shape. The drug 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 drug bag 10 is suspended and held by the suspension hole 16 on an infusion stand or the like to perform infusion or dialysis.

  The weak seal portion 18 (the partition wall of the present invention) extends over the entire width at an intermediate portion in the length direction of the drug bag 10, and the inner surfaces of the drug bag 10 are bonded to each other by the weak seal portion 18. 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 as a partition wall of the present invention is formed by pressing the front and back surfaces of the synthetic resin film section forming the drug bag 10 at a low temperature (120 ° C. in the case of polyethylene) 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 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. The weak seal portion 18 can be peeled and opened by fluid pressure (pressure of the chemical solution during pressurization), and the first chemical solution and the second chemical solution can be mixed between the compartments 20 and 22.

  The discharge port 12 is a molded product of a synthetic resin having a rigidity and thickness capable of maintaining its form (preferably made of the same plastic material as the drug bag 10 in order to obtain adhesion to the drug bag 10). is there. The discharge port 12 has an opening at both ends, the middle forms a tapered portion 12-1, and is formed in a cylindrical shape having a flange portion 12-2 (FIG. 1) at the upper end. A cap 24 is abutted and welded to the flange portion 12-2, and a rubber inner lid (plug body) 26 is attached to the bottom opening of the cap 24. At the time of infusion such as infusion, the inner lid 26 is punctured by the puncture needle of the infusion set, and the infusion is performed by communicating the internal cavity of the drug bag 10 with the infusion tube. In this embodiment, the synthetic resin film forming the front and back surfaces of the drug bag 10 is heat-adhered at a temperature similar to the welding temperature of the strong seal portion 14 while sandwiching the cylindrical portion 12-3 of the discharge port 12 from above and below. Then, this close contact portion on the outer periphery of the discharge port 12 is represented by 14A (FIG. 4), whereby the drug bag 10 is sealed with respect to the discharge port 12.

The cylindrical portion 12-3 of the discharge port 12 extends into the drug bag 10, and a sealing member 30 is provided at the open end. The sealing member 30 is formed in a tubular shape with a fragile material such as foamed synthetic resin, and has a closed shape at the tip portion 30-1. The sealing member 30 is inserted into the cylindrical portion 12-3 of the discharge port 12 at one end on the opening side (FIGS. 2 and 3), and is firmly fixed by welding or the like. It extends in. It is also possible to integrate the exhaust port 12 and the sealing member 30 by forming the discharge port 12 and the sealing member 30 by casting. The closed end 30-1 of the sealing member 30 located inside the drug bag 10 forms a pair of flat surfaces 30-1A (FIG. 4 ) on the outer periphery, and the drug bag 10 is formed on the flat surface 30-1A. The plastic film facing part is welded in a point shape (point seal) by laser welding or the like. A point seal portion is indicated by 32. This point seal strongly bonds the flat surface 30-1A of the closed end 30-1 of the sealing member 30 and the inner surface facing the synthetic resin film constituting the drug bag 10 so as not to be peeled. Applying an external force in the tensile direction to the sealing member 30 by expanding the medicine bag by the pressing force when the seal portion 18 is opened, thereby leading to reliable destruction and opening of the sealing member 30 formed of a fragile material. Is possible.

  The mounting of the discharge port 12 and the sealing member 30 is not necessarily in a completely sealed state, and it is also included in the present invention that a slight gap exists so as to allow a small amount of chemical liquid to flow.

  When the drug bag 10 is opened, the drug bag 10 is placed on a desk or the like, and the drug bag is pressurized with a palm or the like at the drug solution storage site in the compartment 22 or 20 or both as indicated by an arrow a. The liquid pressure is applied to the site of the weak seal portion 18, and the upper and lower synthetic resin film layers constituting the weak seal portion 18 are peeled and opened. When the weak seal portion 18 is opened, the drug bag 10 is expanded, and the sealing member 30 is firmly integrated with the outer surface 30-1A at the closed end 30-1 on the opposite inner surface of the drug bag 10 at the point seal portion 32. Therefore, the sealing member 30 is applied with an external force (in the direction of arrow b in FIG. 5) in the direction of expanding the medicine bag to the closed end 30-1, and the sealing member 30 is made of a fragile material such as foamed synthetic resin. Since it is formed, the sealing member 30 is broken at the closed end 30-1 as shown in FIG. That is, the sealing member 30 is divided into two parts 30A and 30B integrated on the opposite surface of the synthetic resin film constituting the drug bag 10, and the inside of the drug bag 10 is communicated with the discharge port 12 so that the mixed drug solution can be supplied. It can flow into the discharge port 12. Note that the destruction mode of the sealing member 30 due to external force is not necessarily divided into two parts by the respective welded portions as shown in FIG. 5, and those that are crushed into pieces are also included in the present invention. The opening may be formed so that the inside of the medicine bag 10 communicates with the discharge port 12 by destruction.

  The sealing member can be constituted by mixing a foaming material with synthetic resin and thermoforming. Then, by adjusting to an appropriate foaming rate, it is possible to set an appropriate strength so that reliable destruction is performed. The synthetic resin material is preferably the same material from the viewpoint of adhesiveness with the synthetic resin film constituting the drug bag 10, and when the drug bag 10 is made of polyethylene, the foam material may be a polyethylene-based foam material. preferable.

  In addition, by making the foam material constituting the sealing member 30 suitable air permeability, the exhaust port 12 can be sterilized under wet heat by providing the flowability of the chemical vapor in the drug bag. It is advantageous. That is, it includes a sterilization process as a production process of a multi-chamber container, and is usually performed by heating in a state where a chemical solution is stored in each of the compartments 20 and 22, but by providing the sealing member with air permeability, Since the chemical vapor in the bag 10 is circulated to the discharge port 12 through the breathable sealing member 30, the chemical vapor is filled in the discharge port 12 during autoclaving and efficient sterilization under humid heat is possible. It becomes.

  The sealing member 30 is the same as the material of the discharge port 12 and, in a normal state, has a shape that substantially blocks the inside of the drug bag 10 from the discharge port 12. The present invention also includes a configuration that is weakened by making it appropriately thin as compared with that of the present invention. Even in this configuration, the external force at the time of opening the medicine bag can be applied to the thin sealing member via the welded portion 32 such as a point seal, thereby leading to destruction / opening.

FIG. 1 is a plan view of a multi-chamber container according to the present invention. FIG. 2 is a cross-sectional view along the longitudinal direction of the multi-chamber container according to the present invention, taken along line II-II in FIG. 3 is a cross-sectional view taken along the line III-III in FIG. 4 is a cross-sectional view taken along line IV-IV in FIG. FIG. 5 is similar to FIG. 2 but partially shows a connection portion with the discharge port when the medicine bag is opened.

Explanation of symbols

DESCRIPTION OF SYMBOLS 10 ... Drug bag 12 ... Discharge port 14 ... Strong seal part 18 ... Weak seal part (partition wall)
20, 22 ... 1st, 2nd compartment 26 ... Rubber inner lid 30 ... Sealing member 32 ... Point seal part

Claims (2)

A medicine bag formed of a flexible film, a discharge port attached to the medicine bag for discharging medicine, and a plurality of compartments for storing each medicine are separated into the medicine bag. A partition wall formed by welding the opposite inner surface of the drug bag so that it is peeled open by a pressing force applied from the outside, and the other end is extended from the discharge port toward the inside of the drug bag. A sealing member which is inserted and fixed or cast into the discharge port and formed of a fragile material, which substantially closes the discharge port with respect to the inside of the drug bag in a normal state and is destroyed by an external force; A joining portion that integrally joins a surface facing the sealing member, and the sealing member is caused at the joining portion by the expansion of the medicine bag by the pressing force at the time of separation opening of the partition wall. By being allowed destroyed by external force, the exhaust port is an opening allowed to communicate with the inside the medical bag is formed, brittle material as the original sealing member is heated molded article of the foamed synthetic resin, hot forming of the foamed synthetic resin the sealing member is elegance a cylindrical shape tip is closed as the end inside the medical bag, dual chamber and the facing surface of the outer peripheral surface and the sealing member distal end that make up the joint container. A drug bag formed of a flexible film, a discharge port attached to the drug bag for discharging the drug, a plug provided in the discharge port, and the inside of the drug bag for storing each drug A compartment that is separated into a plurality of compartments and welds the opposing inner surfaces of the medicine bag so that the medicine bag is peeled open by a pressing force applied from the outside to mix the medicines stored in each compartment. A method for discharging a drug from a multi-chamber container provided, wherein the discharge port is formed of a fragile material, and the other end is a discharge port so that one end extends from the discharge port toward the internal cavity of the drug bag is secured to, you exhaust ports inserted or are cast into the exhaust port to substantially close in the normal state with respect to the inner drug bag, a heated molded article of the foamed synthetic resin and internally medical bag That tip is provided with a sealing member having a closed cylindrical as the one end, and joining together the opposing surfaces of the sealing member in the medical bag and the tip, when normally discharge the internal drug bag The plurality of compartments are communicated with each other by substantially closing the port and separating the partition walls with fluid pressure caused by pressurizing the drug bag from the outside during infusion. In addition to mixing the medicines in the compartments, by opening the medicine bag caused by the separation of the partition walls , the sealing member is broken at the tip to guide the mixed medicine to the discharge port, and then the infusion device is punctured into the plug The medicine discharge method from the multi-chamber container which started the medicine discharge by doing.

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