JP4587096B2 - Medical multi-chamber container with unmixing prevention mechanism - Google Patents

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 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. 9 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.

Multi-chamber container according to claim 1, a deformable container wall, and a sealed discharge section, the interior of the container wall is divided into a plurality of storage chambers by communicable partitioning means container and having a body, a portion of the container body has a protective member for protecting the outside, said the plurality of storage chambers to a multi-chamber container houses product is housed respectively discharged by mixing the The container wall of the container body includes a first part and a second part that is provided closer to the discharge portion than the first part and has a longer outer peripheral length than the first part. The locking portion that protects the discharge portion, which is a part of the container body, from the outside so as not to open , and is locked to the outer periphery of the first portion in a non-joined state surrounding the first portion. the a, the engaging portion via the outer periphery of the second portion by deforming the second portion removal Configured ability said second portion, before communicating said partitioning means is maintained at a greater peripheral shape than the locking portion, wherein the rear communication partitioning means, the smaller peripheral shape than the locking portion It can be deformed.

  In addition to the structure of claim 1, the invention described in claim 2 is a bag-like or cylindrical thing made of a sheet that shrinks when heated, and is adjacent to the suspension hole. The storage chamber is covered with a protective member.

According to a third aspect of the present invention, in addition to the configuration of the second aspect, a stopper having a groove is attached in the vicinity of the partition means in a state where the partition means is inserted into the groove, The protective member has a gap smaller than the thickness of the accommodation chamber adjacent to the suspension hole, and the protection member is attached so as to cover the stopper from the outside and surround the outer periphery in the vicinity of the partition means, and before opening the partition means capable of communication Is characterized in that the protective member cannot be removed because the opening of the protective member is caught by the stopper.
According to a fourth aspect of the present invention, in addition to the configuration of the first or second aspect, the partition means capable of communicating directly welds the inner surfaces of the flexible sheet forming the medical multi-chamber container. It is characterized in that it is either a direct welding method as described above or a multilayer insert film nipping heat welding method in which a multilayer insert film is nipped between flexible sheets.

According to the first aspect of the present invention, after the partitioning means capable of communicating is opened and the liquid medicine in the storage chamber adjacent to the suspension hole 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 mixing the drug and removing the protective member from the medical multi-chamber container, the suspension hole of the medical multi-chamber container is hooked on a column or the like, and the puncture needle of the infusion set is inserted into the rubber stopper of the discharge port. Since it can be administered to a patient, it can be reliably prevented from being administered to the patient without mixing the drug by mistake.
Furthermore, when filling the storage chamber on the discharge port side and filling the liquid chamber in the storage chamber adjacent to the suspension hole, it can be filled using the discharge port or the opening on the suspension hole side as in the prior art. So existing equipment can be used.

Further, according to the invention described in claim 2, since the protective member uses a bag-like or cylindrical one made of a sheet that shrinks when heated, the manufacturing process is easy and the medicine is mixed by mistake. Without being administered to the patient without fail.

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 that is closed on one side and opened on the other is attached to the medical multi-chamber container 1 so as to cover the first storage chamber 5 and the suspension hole 8. The open end 10 of the protection member 4 is narrowed in the vicinity of the partitioning means 7 that can be communicated. When the medicine a is stored in the first storage chamber 5, the protection member 4 is placed in the medical multi-chamber container 1. Can not be removed from.
The protective member 4 has a cylindrical shape or a bag-like shape that contracts by heating, but a bag-like shape in which three sides are closed and one side is opened is more preferable. 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-shaped container formed by heat-welding or bonding the open ends of a single-layer or multi-layer tubular 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 sandwiching 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 suspension hole 8 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 a in the first storage chamber 5 is moved to the second storage chamber 6.

Further, the second storage chamber 6 is filled with a powdery drug b that cannot be autoclaved because it is easily hydrolyzed, or a liquid drug b that cannot be autoclaved because of poor thermal stability. In this case, first, the first container 5 is filled with the liquid medicine a from the opening at the end of the suspension hole 8, and then the opening is sealed by heat welding or the like. Next, autoclaving is performed to sterilize the drug a. After that, in the aseptic space, the second storage chamber 6 is aseptically filled with the powdery medicine b or the liquid medicine b from the discharge port 3, and a rubber stopper 9 is attached and sealed. And the protection member 4 is attached to the 1st storage chamber 5 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 drug, the mixed drug is moved to the second storage chamber 6. There is no medicine in the first storage chamber 5, and the first storage chamber 5 can be freely deformed. Therefore, the first accommodation chamber 5 and the suspension hole 8 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.
As described above, when the protective member 4 is attached to the medical multi-chamber container 1 in the state before mixing the medicine, the suspension hole 8 is closed, and the medical multi-chamber container 1 is attached to the column or the like. The drug cannot be administered to the patient. Accordingly, it is possible to reliably prevent administration of the medicine without mixing the medicine by mistake.

A second embodiment of the medical multi-chamber container according to the present invention will be described. 4 is a plan view of a second embodiment of the medical multi-chamber container according to the present invention, FIG. 5 is a cross-sectional view of the XX portion of the medical multi-chamber container of FIG. 4, and FIG. FIG. 7 is a perspective view of a stopper used in the medical multi-chamber container, and FIG. 7 is a cross-sectional view of the YY portion of the medical multi-chamber container in FIG.
As shown in FIG. 4, the medical multi-chamber container 21 includes a container main body 2, a discharge port portion 3, and a protection member 4 in the same manner as the medical multi-chamber container 1 of 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 21 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 stopper 11 shown in FIG. 6 is installed in the vicinity of the partitioning means 7 that can communicate, and covers the first storage chamber 5, the suspension hole 8, and the stopper 11. A protective member 4 is attached. As shown in FIG. 5, the stopper 11 is attached to the medical multi-chamber container 21 so as to insert a portion of the partition means 7 capable of communicating with the medical multi-chamber container 21 into the groove 12 of the stopper 11.

Since the gap 11a of the stopper 11 is smaller than the thickness i of the first storage chamber 5, when the medicine a is stored in the first storage chamber 5, the stopper 11 is moved and removed from the first storage chamber 5. I can't. The bag-shaped protective member 4 attached so as to cover the stopper 11 cannot be removed from the medical multi-chamber container unless the open end 11 is caught by the stopper 11 and the stopper 11 is removed. The protective member 4 keeps the suspension hole 8 protected.
Therefore, in the state before mixing of the medicine, the protective member 4 cannot be removed from the medical multi-chamber container 21 and the suspension hole 8 is closed, and the medical multi-chamber container 21 is suspended from a column or the like. I can't administer the drug to my patient. Accordingly, it is possible to reliably prevent administration of the medicine without mixing the medicine by mistake.

A third embodiment of the medical multi-chamber container according to the present invention will be described. FIG. 7 is a plan view of a third embodiment of the medical multi-chamber container according to the present invention, and FIG. 8 is a side partial sectional view of the medical multi-chamber container of FIG.
As shown in FIGS. 7 and 8, 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 31 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 U that is an opening . The protective molded body 241 is attached to the medical multi-chamber container 31 so that the partition means 7 that can communicate with the inside of the gap c of the protective molded body 241 exists. The protective sheet 242 is attached to the protective molded body 241 so as to cover the first storage chamber 5 and the suspension hole 8. Since the gap c of the protective molded body 241 is smaller than the thickness d of the first storage chamber 5, the protective molded body 241 cannot be moved in a state where the medicine a is stored in the first storage chamber 5. The protective sheet 242 keeps the suspension hole 8 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 drug, the mixed drug is moved to the second storage chamber 6. The first storage chamber 5 is in a state where no medicine is present, and the thickness D of the first storage chamber is smaller than the gap U of the protective molded body 241. Therefore, the protection member 241 can move to the first storage chamber 5 side, and the suspension hole 8 is opened from the protection sheet 242. Then, the medical multi-chamber container 31 is suspended from a support column or the like by the opened suspension hole 8, and a puncture needle of an infusion set is inserted into the rubber plug 9 of the discharge port 3 and administered to the patient.
As described above, since the suspension hole 8 of the medical multi-chamber container 31 is protected by the protective sheet 242 in the state before mixing of the medicine, the medical multi-chamber container 31 cannot be suspended from a column or the like. So the drug cannot be administered to the patient. 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 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. It is sectional drawing of the XX part of the medical multiple-chamber container of FIG. It is a perspective view of the stopper of the medical multiple-chamber container of FIG. It is sectional drawing of the YY part of the medical multiple-chamber container of FIG. It is a top view which shows the medical multiple chamber container of 3rd embodiment of this invention. It is a side surface fragmentary sectional view of the medical multiple-chamber container of FIG. 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 11 Stopper 12 Groove 21 Medical multi-chamber container 24 Protective member 241 Protection molded body 242 Protective sheet 31 Medical multi-chamber container 61 Conventional medical multi-chamber container 70 First housing chamber 71 Second housing chamber 72 Weak seal portion 73 for partitioning Weak seal portion 74 for discharging Chemical solution outlet

Claims (4)

A plurality of storage chambers, a communicable partitioning means for partitioning between the plurality of accommodating chambers, and the outlet portion provided at one end for discharging the accommodated drug in said plurality of storage chambers in a mixed state, e Bei the suspension hole provided at the other end, and a protection member for covering the suspension hole,
Liquid medicine is stored in a storage chamber adjacent to the suspension hole ,
The protective member has an opening disposed so as to surround the outer periphery in the vicinity of the partition means;
Before opening of the communicable partitioning means it can not receiving chamber adjacent to the suspension hole detaching the protective member by not pass through the opening, after opening of said communicable partitioning means, By moving the liquid medicine from the storage chamber adjacent to the suspension hole to another storage chamber and deforming the storage chamber adjacent to the suspension hole, the storage chamber adjacent to the suspension hole passes through the opening and passes through the opening. A medical multi-chamber container, wherein the protective member can be removed from the suspension hole.   2. The bag according to claim 1, wherein the protective member is a bag-like or cylindrical one made of a sheet that shrinks when heated, and the protective member covers a storage chamber adjacent to the suspension hole. Medical multi-chamber container. In the vicinity of the partition means, a stopper having a groove is attached in a state where the partition means is inserted into the groove, and the groove has a gap smaller than the thickness of the accommodation chamber adjacent to the suspension hole,
The protective member is attached so as to cover the stopper from the outside and surround the outer periphery in the vicinity of the partition means, and before opening the partition means capable of communicating, the opening of the protective member is caught by the stopper, The medical multi-chamber container according to claim 2, wherein the protective member cannot be removed. 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 medical multi-chamber container according to any one of claims 1 to 3, which is any one of the multi-layer insert film nipping heat welding methods.

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