JP2005211558A - Medical double-chamber container with unopened use preventive mechanism - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a low production cost double-chamber drug container for medical use containing one drug in each chamber so as to securely administer the drugs to a patient without mixing drugs by mistake. <P>SOLUTION: The double-chamber container is composed of a first chamber 5, a second chamber 6, a communicable divider 7 dividing both chambers 5 and 6, a discharge outlet 3 connected to the second chamber 6 to discharge the drug contained in the second chamber 6, and a protective member 4 preventing the discharge outlet 3 from opening. The protective member 4 is disposed so as to cover the discharge outlet 3. A liquid drug is stored in the second storing chamber 6 to which the discharging outlet 3 is connected, and the communicable divider 7 can be opened to connect the discharge outlet 3 and transfer the liquid drug from the second chamber 6 to the first chamber 5 to remove the protective member 4 from the discharge outlet 3. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

  The present invention comprises a medical multi-chamber container, and more specifically, a plurality of chambers for individually storing various unstable drugs (liquid, powder, or solid agent) that change with time when mixed at the same time. The present invention relates to a medical multi-chamber container capable of mixing medicines stored in each chamber in a sterile state and without generating foreign matter by opening the communicating partition means.

  In recent years, among drugs administered to patients by injection, there are unstable drugs that cause undesirable changes over time when pre-mixed. For example, when an amino acid infusion solution and a glucose infusion solution are blended and stored, the mixed solution browns by a so-called Maillard reaction. Further, when the fat emulsion and the electrolyte solution are blended and stored, the fat is aggregated, and when the phosphate-containing liquid and the calcium-containing liquid are blended, precipitation of calcium phosphate occurs. In addition, most antibiotics are stored in an aqueous solution, causing hydrolysis and alteration of the drug, causing undesirable changes.

For such drugs, medical multi-chamber containers that individually contain the components before mixing are often used. This medical multi-chamber container includes a plurality of storage chambers that are stored individually, and a partition weak seal portion that partitions the storage chambers and can be separated by applying pressure from the outside.

Each storage chamber of the medical multi-chamber container stores various drugs a and b that are not desirable when mixed or dissolved in advance, and these drugs a and b are separated by a weak seal for partitioning. Stored safely and reliably until use. In use, when the storage chamber is pressed from the outside, the partition weak seal part is peeled off, the both storage chambers are in communication with each other, and both drugs a and b can be quickly mixed or dissolved.
Furthermore, the medical multi-chamber container is provided with a suspension hole for hanging on one end of a medical column and the other end with a chemical solution discharge port having a rubber stopper. When administering a mixed medicine to a patient, the container is suspended from a support column or the like by a suspension hole, and then a puncture needle of an infusion set is inserted into a rubber stopper of a drug solution outlet, and then administered to the patient.

However, such a medical multi-chamber container often stores the liquid in the storage chamber on the side of the chemical liquid discharge port, and the piercing needle is inserted into the rubber stopper without peeling off the weak seal portion for partitioning. However, there is a possibility that the liquid medicine is taken out from the chemical liquid outlet.
In order to solve this problem, a medical multi-chamber container 61 shown in FIG. 6 disclosed in JP-A-2002-136570 has been proposed. The medical multi-chamber container 61 includes a first and second storage chambers 70, 71, a partition weak seal 72 that partitions the storage chambers 70, 71, a chemical solution discharge port 74 connected to the second storage chamber 71, A discharge weak seal portion 73 that partitions between the second storage chamber and the chemical solution discharge port 74, the liquid medicine is stored in at least one of the storage chambers 70, 71, and the partition weak seal portion 72 and the discharge weak seal portion 72 The weak seal portion 73 is opened by increasing the pressure in the storage chambers 70 and 71, and the pressure necessary to open the discharge weak seal portion 73 is necessary to open the partition weak seal portion 72. The pressure is larger than the normal pressure. Thereby, when pressing each storage chamber and mixing the chemical | medical agent accommodated in each storage chamber, since the weak seal part 72 for partitions opens before the weak seal part 73 for discharge | emission, the weak seal part 73 for discharge | emission is carried out. Only the opening can be prevented. Furthermore, accidents in which the drug is administered to the patient without mixing it by mistake are prevented.
JP 2002-136570 A

  The medical multi-chamber container 41 disclosed in Japanese Patent Application Laid-Open No. 2002-136570 requires pressure necessary for opening the discharge weak seal portion 53 to actually open the partition weak seal portion 52 when actually manufactured. It is difficult to always produce a stable seal by adjusting the seal strength of the weak seal portions 52 and 53 so that the pressure is larger than the required pressure, and the seal strength of the weak seal portions 52 and 53 is adjusted as set. It cannot be confirmed whether or not each weak seal portion 52, 53 is opened. Therefore, it was not possible to reliably prevent administration to a patient without mixing the drug by mistake. Japanese Patent Laid-Open No. 2002-136570 does not describe a manufacturing method, but the liquid medicine is stored in the second storage chamber 51 formed between the partition weak seal portion 52 and the discharge weak seal portion 53. Thus, it cannot be injected from the chemical solution outlet 54 as in the prior art. Therefore, it is necessary to prepare a medical solution filling machine dedicated to the medical multi-chamber container, which requires a large capital investment, and a filling opening provided between the partition weak seal portion 52 and the discharge weak seal portion 53. Since it is very difficult to secure a large filling opening without peeling off the weak seal portions 52 and 53, the production speed is considerably slow.

  The invention according to claim 1, which solves the above-described problem, discharges a medicine stored in a storage chamber connected to the storage chamber, a plurality of storage chambers, a partitioning means capable of partitioning the storage chamber, And a protective member for preventing the opening of the discharge port, and the protection member is attached so as to cover the discharge port, and the storage is connected to the discharge port. The protective member is removed from the discharge port by moving the liquid drug from the storage chamber in which the liquid drug is stored in the chamber and the communicating partition means is opened and the discharge port is connected. Is possible.

  In addition to the structure of claim 1, the invention of claim 2 is a bag-shaped one in which the protective member is formed of a sheet that contracts by heating, and has a discharge chamber. And a protective member covering the stopper.

  Furthermore, in the invention described in claim 3, in addition to the configuration described in claim 1 or claim 2, the communicating partition means directly connects the inner surfaces of the flexible sheet forming the medical multi-chamber container. It is either a direct welding method in which welding is performed, or a multilayer insert film sandwiching heat welding method in which a multilayer insert film is sandwiched between flexible sheets.

According to the first aspect of the present invention, after the partition means capable of communication is opened and the liquid agent in the storage chamber on the discharge port side is moved to another storage chamber, the protective member is removed from the medical multi-chamber container. It has a structure that can be removed. Therefore, after removing the protective member from the medical multi-chamber container, the puncture needle of the infusion set can be inserted into the rubber stopper at the discharge port and administered to the patient. Administration can be reliably prevented.
Furthermore, when the liquid agent is filled in the storage chamber on the discharge port side, the existing facility can be used because it can be filled using the discharge port as in the conventional case.
According to the second aspect of the present invention, since the protective member is a bag-shaped member made of a sheet that shrinks when heated, the manufacturing process is easy, and it is administered to the patient without mixing the medicine by mistake. This can be surely prevented.
Furthermore, according to the invention described in claim 3, the inner surface of the flexible sheet forming the medical multi-chamber container is directly welded to each other, or the multilayer insert film is narrowed between the flexible sheets. By using a partition means that can be communicated, which is one of the multilayer insert film sandwich heat welding systems that are welded in the holding state, the opening operation and the mixing operation are easy, and the patient is not mixed by mistake. Can be reliably prevented.

Embodiments of the present invention will be described below.
FIG. 1 is a plan view of a first embodiment of a medical multi-chamber container according to the present invention, and FIG. 2 is a side sectional view of the medical multi-chamber container of FIG.
As shown in FIGS. 1 and 2, the medical multi-chamber container 1 includes a container body 2, a discharge port portion 3, and a protection member 4. The container body 2 includes a first storage chamber 5, a second storage chamber 6, and a partition unit 7 that can communicate between the two storage chambers 5 and 6. A suspension hole 8 for suspending the medical multi-chamber container 1 is provided at one end of the first storage chamber 5, and a discharge port portion 3 is provided at one end of the second storage chamber 6. The discharge port 3 is sealed with a rubber plug 9. Each of the storage chambers 5 and 6 stores various drugs a and b which are not desirable when mixed or dissolved in advance.

The bag-shaped protective member 4 which is closed on one side and opened on the other side is attached to the medical multi-chamber container 1 so as to cover the discharge port portion 3 to which the second storage chamber 6 and the rubber stopper 9 are attached. ing. The open end 10 of the protective member 4 is narrowed in the vicinity of the partitioning means 7 that can be communicated. When the medicine b is stored in the second storage chamber 6, the protective member 4 is placed in the medical multi-chamber container 1. Can not be removed from.
The protective member 4 preferably has a bag-like form in which three sides that shrink by heating are closed and one side is opened. The medical multi-chamber container is inserted from the open end formed large in advance, and then the bag-like protective member is contracted by heating, and the open end of the protective member becomes small so as to be in close contact with the partition means. It is very easy. As the protective member, it is possible to use a protective member having a property of shrinking when a film made of polypropylene, polyethylene terephthalate, vinyl chloride resin or the like is stretched and heated.

The medical multi-chamber container 1 is a bag-like container formed by thermally welding or bonding the open ends of a single-layer or multi-layer tube-shaped film. As the material of the film, resins such as polyethylene, polypropylene, and cyclic polyolefin can be employed. Although the medical multi-chamber container of the present invention is produced using a tube-shaped film, it is a bag-shaped container formed by thermally welding or bonding the peripheral portions of two single-layer or multi-layer films. It can also be.

The partition means 7 which can communicate is formed so that opening is possible by various aspects. For example, the weak sealing part can be formed by the so-called direct welding method in which the inner surfaces of the film forming the medical multi-chamber container 1 are directly bonded to each other by thermal welding, and the partition means 7 can be communicated. Moreover, the partition means 7 which forms a weak seal part and can communicate by what is called a multilayer insert film nipping thermal welding system which welds in the state which pinched | interposed the multilayer insert film between the films of the both sides which form the medical multiple-chamber container 1 Can be.
Also, instead of the weak seal portion as the partitioning means that can be communicated constituted by the direct welding method or the multilayer insert film nipping heat welding method, a pipe breakage method (see Japanese Patent Laid-Open No. 4-364651) or a removable clip can be used. A clip method (see Japanese Patent Laid-Open No. 63-309263) in which both storage chambers are partitioned by holding a flexible sheet, and a communication needle method in which a diaphragm partitioned into a plurality of storage chambers is opened with a communication needle ( Japanese Patent Laid-Open No. 2002-253639) can also be adopted.

Next, the manufacturing method of the medical multi-chamber container of this invention is demonstrated. First, the second storage chamber 6 of the medical multi-chamber container 1 is filled with the liquid medicine b from the discharge port 3, and a rubber stopper 9 is attached and sealed. Next, the first storage chamber 5 of the medical multi-chamber container 1 is filled with the liquid medicine a from the opening at the end on the suspension hole 8 side, and then the opening is sealed by heat welding or the like. If both drugs a and b are liquid drugs having excellent thermal stability, the medical multi-chamber container 1 filled with the drugs a and b can be sterilized by autoclaving to sterilize the drugs a and b. Next, the medical multi-chamber container 1 is inserted into the protective member 4 from the open end 10 of the heat-shrinkable bag-shaped protective member 4 from the outlet 3 side. The open end 10 is large enough to allow easy insertion of a medical multi-chamber container. When heat of a certain level or more is applied to the bag-shaped protective member 4 with the medical multi-chamber container 1 inserted, the bag-shaped protective member 4 is contracted as a whole, and the open end 10 is in close contact with the partition means 7. And the opening of the open end 10 becomes smaller. Thus, the protective member 4 cannot be removed from the medical multi-chamber container 1 unless the partition means 7 is opened and the medicine b in the second storage chamber 6 is moved to the first storage chamber 5.

Also, the first container 5 is filled with a powdered drug a that cannot be autoclaved because it is easily hydrolyzed, or a liquid drug a that cannot be autoclaved because of poor thermal stability. In this case, first, the liquid medicine b is filled into the second storage chamber 6 from the discharge port portion 3, and a rubber stopper 9 is attached and sealed. Next, the medicine b is sterilized by autoclaving. Then, in the aseptic space, the powdered medicine a or the liquid medicine a is aseptically filled into the first storage chamber 5 from the opening at the end of the suspension hole 8, and then the opening is heat welded. Seal with etc. And the protection member 4 is attached to the 2nd storage chamber 6 as mentioned above.

Next, the usage method of the medical multi-chamber container 1 is demonstrated based on FIG. When the storage chambers 5 and 6 are pressed from the outside, the partitioning means 7 capable of communicating is opened, and the drugs a and b are mixed. After mixing the medicine, the mixed medicine is moved to the first storage chamber 5. The medicine is not present in the second storage chamber 6 and can be freely deformed. Therefore, the discharge port 3 sealed with the second storage chamber 6 and the rubber plug 9 can pass through the open end 10 of the protection member 4, and the protection member 4 is completely removed from the medical multi-chamber container 1. Then, after the medical multi-chamber container 1 is suspended from a suspension column 8 by a suspension hole 8, a puncture needle of an infusion set is inserted into the rubber plug 9 of the discharge port 3 and administered to a patient.
Thus, since the protective member 4 is attached to the medical multi-chamber container 1 in the state before mixing of the medicine, it is possible to insert the puncture needle of the infusion set into the rubber plug 9 of the discharge port 3. Can not. In this way, it is possible to reliably prevent administration to a patient without mixing the medicine by mistake.

A second embodiment of the medical multi-chamber container according to the present invention will be described. FIG. 4 is a plan view of a second embodiment of the medical multi-chamber container according to the present invention, and FIG. 5 is a side partial sectional view of the medical multi-chamber container of FIG.
As shown in FIGS. 4 and 5, the medical multi-chamber container 31 includes a container body 2, a discharge port portion 3, and a protection member 24. Similar to the first embodiment, the container body 2 includes a first storage chamber 5, a second storage chamber 6, and a partition unit 7 that can communicate between the two storage chambers 5 and 6. A suspension hole 8 for suspending the medical multi-chamber container 1 is provided at one end of the first storage chamber 5, and a discharge port portion 3 is provided at one end of the second storage chamber 6. The discharge port 3 is sealed with a rubber plug 9. Each of the storage chambers 5 and 6 stores various drugs a and b which are not desirable when mixed or dissolved in advance.

The protection member 24 is composed of a protection molded body 241 and a protection sheet 242 having a certain gap (a). The protective molded body 241 is attached to the medical multi-chamber container 31 so that the partition means 7 which can communicate with the inside of the clearance gap of the protective molded body 241 exists. The protective sheet 242 is attached to the protective molded body 241 so as to cover the discharge port 3 to which the second storage chamber 6 and the rubber plug 9 are attached. Since the clearance a of the protective molded body 241 is smaller than the thickness i of the second storage chamber 6, the protective molded body 241 cannot be moved in the state where the medicine b is stored in the second storage chamber 6. The protective sheet 242 keeps the state where the discharge port portion 3 is protected.

As in the first embodiment, when the storage chambers 5 and 6 are pressed from the outside, the partitioning means 7 capable of communicating is opened, and the drugs a and b are mixed. After mixing the medicine, the mixed medicine is moved to the first storage chamber 5. There is no medicine in the second storage chamber 6, and the thickness i of the second storage chamber is smaller than the gap (a) of the protective molded body 241. Therefore, the protection member 241 can be moved to the second storage chamber 6 side, and the discharge port portion 3 sealed with the rubber stopper 9 is opened from the protection sheet 242. Then, after the medical multi-chamber container 1 is suspended from a support column or the like through the suspension hole 8, a puncture needle of an infusion set is inserted into the rubber plug 9 of the opened discharge port 3 and administered to a patient.
Thus, since the rubber plug 9 of the discharge port 3 of the medical multi-chamber container 31 is protected by the protective sheet 242 in the state before mixing of the medicine, the rubber plug 9 of the discharge port 3 is attached to the rubber plug 9. I cannot insert the needle of the infusion set. In this way, it is possible to reliably prevent administration to a patient without mixing the medicine by mistake.

It is a top view which shows the medical multiple chamber container of 1st embodiment of this invention. It is a side surface fragmentary sectional view of the medical multiple-chamber container of FIG. It is a side surface fragmentary sectional view which shows the state which has removed the protection member from the medical multiple-chamber container of FIG. It is a top view which shows the medical multiple chamber container of 2nd embodiment of this invention. FIG. 1 is a side sectional view of a medical multi-chamber container. It is a top view which shows an example of the conventional medical multiple chamber container.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Medical multiple-chamber container 2 Container main body 3 Outlet part 4 Protection member 5 1st storage chamber 6 2nd storage chamber 7 Partition means 8 Suspension hole 9 Rubber stopper 10 Open end 21 Medical multi-chamber container 24 Protection member 241 Protection Molded body 242 Protective sheet 61 Conventional medical multi-chamber container 70 First housing chamber 71 Second housing chamber 72 Weak seal portion 73 for partition Weak seal portion 74 for discharge Chemical solution outlet

Claims (3)

A plurality of storage chambers, a partitioning means for partitioning the storage chambers, a discharge port portion for discharging a medicine stored in the storage chamber connected to the storage chamber, and an opening of the discharge port portion are prevented. A protective member for covering the discharge port portion, the protective member is attached so as to cover the discharge port portion, the liquid medicine is stored in a storage chamber to which the discharge port portion is connected, A medical multi-chamber container, wherein the protective member can be removed from the discharge port portion by moving the liquid medicine from the storage chamber opened and connected to the discharge port portion to another storage chamber. 2. The medical compound according to claim 1, wherein the protective member is a bag-shaped member formed of a sheet that shrinks by heating, and the protective member covers the accommodation chamber having the discharge port portion. Chamber container. The communicating partition means is a direct welding method in which the inner surfaces of the flexible sheets forming the multi-chamber container are directly welded to each other or a multilayer insert film is sandwiched between the flexible sheets. The multi-chamber container for medical use according to claim 1 or 2, which is any one of the multi-layer insert film nipping heat welding methods.

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