JP2008061669A - Multi-chamber container - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a multi-chamber container which reliably mixes medicaments and discharge the mixed medicament. <P>SOLUTION: A cylindrical insert 30 made of a rubber is press-fitted in and is welded to the inner circumference of a discharge outlet 12 inside the discharge outlet 12. The insert 30 is formed into a cylindrical shape with an elastomer rubber having an adequate thickness, and the central part is displaced due to the elasticity between a first state in which the central part is curved and protruded greatly into a hollow side of a medicament bag 10 and is substantially closed and a second state in which the central part is protruded to the side of a rubber stopper 20 and is opened. When the welded part between the separated chambers is not opened, the insert remains in the first shape, and the discharge of the medicament is prevented since the liquid flow is not initiated substantially even if the rubber stopper is punctured. The insert is transformed from the first shape into the second shape by liquid pressure at the time of the opening of the welded part. Since an opening part is formed on the insert 30, the medicament is discharged through the opening part. <P>COPYRIGHT: (C)2008,JPO&INPIT

Description

  This invention consists of a drug bag in which the internal cavity is separated by a seal portion, each of which forms a plurality of compartments for separately storing and storing a chemical solution, and after the chemical solution from each compartment is mixed The present invention relates to a multi-chamber container which is discharged from a discharge port and an infusion method.

In a multi-chamber container for infusion, the container separated by a weak seal part formed by welding the opposite surfaces of a drug bag made of a soft film at a relatively low temperature is divided into a plurality of compartments each containing different drug solutions. is there. 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 is open to one compartment on one end side, but the other end is a rubber A stopper is provided. Prior to administration of the drug solution to the patient, the weak seal is peeled open by pressurizing the drug bag from the outside, and the drug bag has a single internal cavity, so the two types of drug solution are mixed and the infusion set is punctured A rubber stopper is punctured with a needle, and a drug solution can be administered from a drug bag. Therefore, in this type of medical mixed-type multi-chamber container, it is essential to mix the two liquids by peeling and opening the weak seal portion prior to the administration of the chemical solution, while the weak seal portion is not opened. When the rubber stopper is punctured at the discharge port, 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 prior art to cope with this problem, in addition to the first weak seal portion that separates the internal cavity of the drug bag into two compartments, a second weak seal portion is provided immediately before the discharge port, By setting the second second weak seal portion to be equal to or higher than the pressure required for opening the 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 discharge port (at a position apart from the first weak seal portion). In order to prevent the administration of unmixed chemical solution by sequentially opening the weak seal part, two weak seal parts are provided depending on the welding temperature, which complicates the manufacturing process and increases costs. It was. Further, even if the welding strength of the seal portion is set as the first weak seal portion <the second weak seal portion, the seal portion is located in a portion separated from each other in the drug bag, and thus the first weak seal portion and the second weak seal portion Since there is a slow speed in the transmission of the pressure wave at the time of opening the drug bag to the weak seal portion, it cannot be said that the same pressure is applied in time series in the first weak seal portion and the second weak seal portion. Depending on how the drug bag is pressurized (how the pressure wave is transmitted), a large force is initially applied to the second seal portion and the second seal portion is opened, and the drug solution flows out to the discharge port. It may disappear immediately and the first seal may remain unopened. In this case, there is a possibility of shifting to the administration work as it is due to puncturing, and only one solution is administered without mixing.

  The present invention has been made in view of the above-mentioned problems, and provides a novel structure of a multi-liquid mixed type drug bag that cannot be administered in an unopened state, is low in manufacturing cost, and is low on the user side. The object is to more surely eliminate the possibility of erroneous operation despite the fact that the workability of the above is good.

  The multi-chamber container according to the present invention is formed of a flexible film and welds the opposing surfaces of the drug bag so as to be pressure-separated so as to separate the internal cavity into a plurality of compartments for storing respective chemical solutions. A multi-chamber container including a drug bag having a welded portion and a discharge port provided with a stopper punctured by an infusion set for discharging the drug solution, the discharge port being located on the side of the internal cavity of the drug bag A flexible communication control member, and the flexible communication control member normally has a first shape for substantially closing the discharge port with respect to the internal cavity of the drug bag, and is welded by pressure. The flexible communication control member is deformed from the first shape by the internal hydraulic pressure caused when the peeling is opened, and has a second shape that allows the discharge port to communicate with the internal cavity of the drug bag.

  The flexible communication control member can be configured as a rubber cylindrical insert or the like, and in a normal state, the flexible communication control member has a first shape that substantially closes the discharge port with respect to the internal cavity of the drug bag (the drug bag Therefore, even if the puncture needle of the infusion set is accidentally punctured into the plug body, a substantial liquid flow cannot be obtained, and the infusion work is performed only with the medicine in one compartment. If you do, it will not be ugly. Here, substantially closed means that some opening of the flexible communication control member is allowed, and a small amount of drug solution can be initially administered by puncture due to the presence of some gap. However, since it cannot keep up with the dripping speed, no further administration is possible, so there is no practical problem. Moreover, since a small amount of chemical liquid leaks to the discharge port side via the flexible communication control member, there is an advantage that sterilization guarantee work at the time of manufacture becomes easy.

  When the welded portion is isolated and opened by pressurizing the infusion bag, a fluid pressure that instantaneously increases is generated inside the drug bag. Due to this high fluid pressure, the flexible communication control member makes the discharge port open to the drug bag due to its elasticity. In order to form a second shape that communicates with the internal cavity of the drug bag (a shape that is biased toward the side away from the internal cavity of the drug bag, that is, the plug body), the puncture needle of the infusion set is punctured into the plug body. The sexual communication control member is also broken by the puncture needle, and the mixed drug solution can be guided to the infusion set to perform the infusion.

  The flexible communication control member provided at the drug discharge port is substantially closed when not opened, so that the drug administration is substantially blocked, thereby preventing erroneous administration of the drug in an unopened state. In addition, by deforming the flexible communication control member by the fluid pressure at the time of opening into the second shape opened, the opening operation (mixing of the drug solution) of the drug bag can be interlocked with the administration of the drug, and there is no mistake An efficient infusion operation can be realized.

  1 to 3, the multi-chamber container includes a flat drug bag 10 for storing a chemical solution and a cylindrical discharge port 12. The drug bag 10 is made of a synthetic resin soft film (flexible film of the present invention) having a multilayer structure such as a polyethylene film having a thickness of 200 microns. The synthetic resin soft film constituting the drug bag 10 has a pair of sections 11A and 11B stacked with the cylindrical discharge port 12 sandwiched therebetween. When the entire outer peripheral portion is made of polyethylene, it is welded at a high temperature of 130 ° C. The strong seal portion 14 is formed along the entire circumference including the region. Welding at parts other than the cylindrical outlet 12 is between polyethylene films, and welding at the part of the cylindrical outlet 12 is between the cylindrical outlet 12 and the polyethylene film, and cannot be welded at the same time. Welding (strong sealing) is performed, and the strong sealing portion at the cylindrical discharge port 12 is indicated by 14-1 to distinguish it from that at the remaining portion. The welding at the strong seal portions 14 and 14-1 is a temperature at which the pressure does not peel at the pressure generated in the drug bag when the drug bag 10 is pressurized to open the drug bag 10 (as described above in the case of polyethylene). Thus, regardless of the influence of external physical force, the drug solution can be held in the drug bag 10 without leaking. The cylindrical discharge port 12 is configured as a thick (rigid) plastic molded product capable of maintaining the cylindrical shape. The cylindrical discharge port 12 protrudes from the drug bag 10 at the lower end of FIG. 1, and a rubber stopper that is punctured by the puncture needle 22 of the infusion set at the lower end of the cylindrical discharge port 12 protruding from the lower end of the drug bag 10 20 (plug) is attached.

  The two synthetic resin film sections 11A and 11B constituting the drug bag 10 are welded so as to be able to be peeled by pressure at the entire width in the longitudinal direction (vertical direction in FIG. 1) of the drug bag 10, and weakly sealed (weld) Part) 24. The inner cavity of the medicine bag 10 is separated into the first and second compartments 26 and 28 in the upper and lower parts of FIG. 1 by the weak seal portion 24, and the first and second compartments 26 and 28 are separated into the first and second compartments, respectively. Can be stored in a separated state. The welding of the left and right synthetic resin film sections 11A and 11B of FIG. 1 constituting the drug bag 10 in the weak seal portion 24 can be performed by pressure separation. The pressure peelable means that when the drug bag 10 is pressed with an appropriate force with a palm or the like for opening the drug bag 10, the synthetic resin film section 11A, 11B is peeled off, and in the case of the polyethylene resin according to the embodiment of the present invention, the welding at the weak seal portion 24 is 120 ° C. (which is considerably lower than the above-described welding temperature such as 130 ° C. for obtaining the strong seal portion 14). The welding temperature). FIG. 4 shows the peeled state of the synthetic resin film sections 11A and 11B due to the opening of the weak seal portion 24.

  A rubber cylindrical insert 30 (a flexible communication control member of the present invention) is disposed inside the discharge port 12. The rubber cylindrical insert 30 has a cylindrical shape, is formed of a rubber material having an appropriate thickness, for example, elastomer rubber, and the outer peripheral edge 30-1 is joined to the inner periphery of the discharge port 12 by welding or the like. . As shown in FIG. 1, the extended portion of the insert 30 is folded inward from the joint edge 30-1, and the folded portion 30-2 has a tapered shape toward the hollow portion of the medicine bag 10. Has a cut (joint) 30-3, but since the rubber material surface constituting the insert 30 is in close contact with the portion of the joint 30-3, the chemical solution substantially circulates through the insert 30. It is not possible. However, this close contact state may be such that a small amount of chemical solution can be allowed to flow, and an optimal sealing degree can be obtained by appropriately selecting a rubber material and a wall thickness. As shown in FIG. 1, the insertion body 30 has a first shape (state) in which the central portion is greatly curved and protrudes toward the inner cavity side (the side away from the rubber plug 20) of the drug bag 10 as shown in FIG. Thus, it is possible to displace between the two stable shapes (states) and the second shape (state) deformed to the rubber plug 20 side (the side away from the internal cavity of the drug bag 10). Needless to say, in order to obtain stability at these two positions (shapes), it is necessary to appropriately set various factors such as the material and thickness of the rubber and the vulcanization conditions in the mold.

  When the medicine bag in which the compartments 26 and 28 are separated by the weak seal portion 24 is not opened, the rubber insert 30 is in the first state in which the central portion projects toward the compartment 26 as shown in FIG. is there. In this case, even if the rubber stopper 20 is inserted by the puncture needle 22 of the infusion set as indicated by a two-dot chain line 22 ', the insert 30 is substantially closed, and the liquid flow through the insert 30 is Since the amount is so small that the drop rate cannot be reached even if a small amount of liquid flow is made through the portion of the seam 30-3, the administration of the drug cannot be performed substantially. It is possible to prevent an erroneous operation (an infusion operation in an unopened state) in which only the drug solution is infused.

  The weak seal portion 24 is opened by placing the drug bag 10 flat on a desk or the like and pressurizing the drug bag 10 with the palm of the hand. That is, both layers of the drug bag 10 are separated at the weak seal portion 24 by the pressure of the chemical liquid applied by pressurization (the state where the weak seal portion 24 is separated is shown in FIG. 4), and the compartments 26 and 28 are integrated. The chemicals separated and accommodated in the compartments 26 and 28 are mixed. And the pressure of the chemical | medical solution produced at the moment of opening of the weak seal | sticker part 24 acts on the whole surface of the insertion body 30 like the arrow f of FIG. 1, and was aiming at the internal cavity of the chemical | medical agent bag 10 in FIG. As shown in FIG. 4, the extended portion 30-2 is inverted so as to be in contact with the inner surface of the discharge port 12, and the tip joint 30-3 is largely separated to form an opening 32. In this second state (shape), since the insert 30 has the opening 32, when the rubber stopper 20 is punctured with the puncture needle 22 ', the mixed drug solution in the drug bag 10 is opened. 32 can be taken out into the infusion set.

  As described above, the closed state (FIG. 1) of the rubber insert 30 does not necessarily need to be 100% sealed. By allowing some leakage through the seam 30-3, the product can be sterilized in the state where there is a chemical solution at the discharge port 12, and sterilization guarantee can be easily obtained. Further, since the drug solution leaks somewhat to the side of the discharge port 12, administration of some drug solution is performed by puncturing the puncture needle of the infusion set with the weak seal portion 24 unopened as indicated by the imaginary line 22 '. However, since it is not possible to keep up with the dropping speed, further administration cannot be continued, so that puncture without opening does not lead to erroneous work.

  In order to improve the work efficiency of mounting the rubber insert 30, as shown in FIG. 5, it may be configured as an assembly in which a cylindrical plastic cap 40 is provided outside the cylindrical insert 30. The cap 40 is formed of the same material (polyethylene) as the discharge port 12. The assembly configured as described above can be simply inserted (press-fitted) into the discharge port 12 to weld the plastic cap 40 and the discharge port 12.

FIG. 1 is a partial cross-sectional view of the multi-chamber container of the present invention, showing an unopened state. FIG. 2 shows a partial plan view of the multi-chamber container of the present invention. 3 is a view taken along the line III-III in FIG. 1 (only the rubber cylindrical insert 30 is shown). FIG. 4 shows the open state of the multi-chamber container of FIG. FIG. 5 is a partial view showing another embodiment of the mounting method of the rubber cylindrical insert.

Explanation of symbols

DESCRIPTION OF SYMBOLS 10 ... Drug bag 12 ... Outlet 14 ... Strong seal part 20 ... Rubber stopper 22 ... Puncture needle 24 ... Weak seal part
26, 28 ... compartment 30 ... rubber cylindrical insert

Claims (4)

  A drug bag comprising a welded portion formed of a flexible film and formed by welding the opposite surfaces of the drug bag so as to be capable of being pressure-separated so as to separate the internal cavity into a plurality of compartments for storing respective drug solutions. And a multi-chamber container having a chemical solution discharge port, wherein the discharge port includes a flexible communication control member for opening and closing the internal cavity of the drug bag, and the flexible communication control member is normally used. In the first embodiment, the discharge port is substantially closed with respect to the internal cavity of the drug bag, and the flexible communication control member is formed by the internal fluid pressure caused when the welded portion is peeled and opened by pressurization. A multi-chamber container having a second shape which is deformed from the first shape and allows the discharge port to communicate with the internal cavity of the drug bag.   2. The multi-chamber container according to claim 1, wherein the flexible communication control member is formed as a cylindrical insert formed of an elastic material.   In the invention according to claim 2, an outer peripheral cylindrical member formed of a plastic material of the same system as the discharge port is provided on the outer periphery of the cylindrical insert, and an assembly is configured with the cylindrical insert. A multi-chamber container in which this assembly is attached to the discharge port. A drug bag comprising a welded portion formed of a flexible film and formed by welding the opposite surfaces of the drug bag so as to be capable of being pressure-separated so as to separate the internal cavity into a plurality of compartments for storing respective drug solutions. And a discharge port provided with a plug punctured by a puncture needle of an infusion set for discharging the drug solution, the discharge port including a flexible communication control member for opening and closing the internal cavity of the drug bag Puncturing the infusion set by preparing a multi-chamber container and presenting a first shape that substantially closes the outlet to the internal cavity of the drug bag when the flexible communication control member is not opened Regardless of the puncture of the plug body with the needle, the infusion is blocked, the welded part is peeled open by pressurization at the start of the infusion, and the internal fluid pressure caused by the pressurization of the welded part is flexible Communication control member The infusion operation is started by deforming from the first shape to form a second shape in which the discharge port communicates with the internal cavity of the drug bag, and punctures with the puncture needle of the infusion set after plugging. Infusion method.

Images