JP4502742B2 - Medical multi-chamber container, manufacturing method thereof and storage method thereof - 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 that can communicate with each other by separating and opening the weak seal portion and mixing the medicines stored in each chamber in a sterile state without generating foreign matter.

    Among drugs administered to patients by intravenous 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. In addition, if fat emulsion and electrolyte solution are blended and stored, the fat will aggregate, and if phosphoric acid-containing liquid and calcium-containing liquid are blended, calcium phosphate will precipitate and undesirable changes will occur. Wake up.

  For such drugs, medical multi-chamber containers that individually store components before mixing are often used. This medical multi-chamber container is provided with a plurality of storage portions for individually storing medicines, or further provided with independent small storage chambers within this storage portion, and each storage portion is partitioned by a weak seal portion or the like to apply pressure from the outside. In addition, these partition portions are peeled and opened (for example, Patent Document 1).

    FIG. 10 is a plan view showing an example of such a conventional medical multi-chamber container, and FIG. 11 is a sectional view taken along line XX of FIG.

  In the storage units 10 and 11 of the medical multi-chamber container 1, various drugs a and b which are undesirable when mixed or dissolved in advance are stored, respectively, and these drugs a and b are separated by a weak seal 20 for partitioning. It is stored safely and reliably until it is used in an isolated state. In use, when the storage portion 10 or 11 is pressed, the partition weak seal portion 20 is peeled off, whereby the inside of the storage portions 10 and 11 is brought into communication, and both the drugs a and b can be quickly mixed or dissolved. .

A portion indicated by a dotted line indicates a small storage chamber 12 for a medicine c provided in the storage section 10, and is opened in conjunction with the peeling opening of the weak seal section 20. Can be mixed with both drugs a and b.
Further, the medical multi-chamber container 1 includes a hanging hole 30 at one end and a drug discharge port 31 having a rubber stopper at the other end. When administering a mixed medicine to a patient, the container is suspended from a support column or the like through the hanging hole 30, and then a piercing needle is inserted into a rubber stopper provided at one end of the container, and the tip of the catheter is injected. Administer to the patient through the needle.

  By the way, such a conventional medical multi-chamber container 1 has a drug ab that has been isolated at a time when the weak seal portion 20 is peeled off by an external pressure due to, for example, a drop impact or a loaded weight during transportation and storage, or the like. Since c is mixed, it is necessary to prevent the medicines from being mixed by communication between the storage units 10 and 11 or these and the small storage chamber 12 until they are used.

    As a countermeasure, conventionally, the medical multi-chamber container 1 is folded in a U-shape as shown in FIG. 12 by folding lines 4p and 4q shown by two parallel chain lines in FIG. The internal pressure is shut off at the broken lines 4p and 4q so as not to be transmitted to the weak seal portion 20 or the opening edge of the small storage chamber 12 (Patent Document 2).

Normally, such a double-folded state is not easily deformed, and thus does not cause the weak seal part to peel off during storage or unintentional mixing of the drug, but any abnormal external force during storage, for example, The folding part is deformed by a drop impact or an unexpected external force acting in the lateral displacement direction. For example, as shown by the solid line in the partial enlarged view of FIG. As a result, the bending angle of the broken lines 4p and 4q may expand, and the pressure blocking effect may be reduced.
JP 2002-136570 A PCT International Publication No. WO 03/092574 A1, page 13, lines 5-23 and FIG. 5

    In the present invention, in order to eliminate the problems of the prior art, when storing a double-folded medical multi-chamber container, the folding line is expanded and changed due to an external force acting unexpectedly during storage. It is another object of the present invention to provide a method for separating a medical multi-chamber container, as well as to surely prevent unintentional mixing of the drugs, as well as to prevent the unintentional mixing of the drugs. And

    A medical multi-chamber container that solves the above-described problems of the present invention includes a container main body having a plurality of storage portions, and a medicine discharge port connected to the storage portion, and the container main body is connected to the plurality of storage portions. A medical multi-chamber container comprising a partition part that is opened and communicated with each other by increasing the pressure in the storage part, and the container body is configured to be folded at the partition part. Is constituted by three or three or more odd-numbered broken lines folded back in a zigzag shape.

  The container main body includes one provided with a small storage chamber in at least one of the storage units.

    And when the number of the folding lines folded in the folding part of the said container main body is made into the minimum 3, the cross-sectional shape of a folding line part becomes a substantially "M" shape.

    Moreover, outer periphery packaging and these container main bodies can also hold | maintain a folding attitude | position compulsorily by packaging from an outer periphery with a folding attitude | position. As the packaging material, in addition to a packaging bag, a fastening band, a band-like adhesive sheet, and the like can be used.

  The container body may be formed of a film made of a mixed material of polyethylene and polypropylene, and the partition weak seal portion may be formed by thermally bonding film surfaces on both sides of the container body. The small storage chamber can also be formed of a film of thermoplastic resin such as polyethylene, polypropylene, polystyrene, etc. Furthermore, a thin film made of these thermoplastic resins is laminated with a weak interlayer adhesive strength, and opened along with delamination It can also be made.

    The medical multi-chamber container having a broken line is pressed against a chevron-shaped heating mold having serrated projections that fit together from the front and back surfaces of the partition part of the container body, and the opening communication function of the partition part of the container body It is manufactured by heating at a temperature that does not affect the above, and plastically deforming it into three or more odd-numbered broken lines folded back in a zigzag manner on the partition portion of the container. In addition, it can replace with this chevron type heating type | mold, and can also manufacture by carrying out the plastic deformation of the heating blade by which it was mutually arranged from the front and back of the partition part of a container main body, and pressingly bent to a seal part.

    The medical multi-chamber container storage method that solves the above-described problems of the present invention includes a container body having a plurality of storage parts, and a medicine discharge port connected to the storage part. The above-mentioned medical multi-chamber container that includes a partition part that is opened and communicated with each other by partitioning into the plurality of storage parts and increasing the pressure in the storage part, and in which the liquid medicine is stored in at least one of the plurality of storage parts. The folding posture is compulsorily maintained by folding the whole into two folds through a fold line folded in an odd zigzag shape of 3 or more along the partition, and wrapping with a packaging member from the outer periphery. It is characterized by that. In this case, a belt-like adhesive sheet can be used as the packaging material.

    Between the storage part and the weak seal part, there is an “M” -shaped broken line part that is folded back at least 3 times in an odd number of times, so even if an external force such as a slightly large lateral displacement is applied The broken line is not deformed and disappeared, and therefore unintended weak seal portion peeling and drug mixing are reliably prevented.

  Further, when the folded container is unfolded flat at the time of use, pressure can be applied to any one of the accommodating portions as in the conventional case, and the weakly sealed portion can be peeled off and the isolated drug can be mixed for use.

    Hereinafter, embodiments of a medical multi-chamber container according to the present invention will be described with reference to the drawings.

  1 is a perspective view of a medical multi-chamber container according to an embodiment of the present invention, FIG. 2 is a plan view of the medical multi-chamber container when a small storage chamber is provided, and FIG. FIG. 4 is a partially enlarged view of FIG. 3, showing a cross-sectional view showing the folded state.

    As shown in FIGS. 1 and 2, a medical multi-chamber container 1 includes a container main body 3 having a rectangular shape in which a peripheral edge portion 2 is thermally bonded, and a medicine outlet having a rubber plug connected to the container main body 3. 31. The container body 3 has a first storage portion 10 and a second storage portion 11 arranged side by side in the longitudinal direction, and the two storage portions 10 and 11 are partitioned by a detachable partition weak seal portion 20. Yes. Each of the storage units 10 and 11 stores various drugs a and b, which are undesirable when mixed or dissolved in advance.

    As a material constituting the container main body 3, films made of various resins such as thermoplastic resins such as polyethylene, polypropylene, and polystyrene can be employed.

    The partition weak seal 20 is formed to be openable in various ways. For example, both sides of the film forming the medical multi-chamber container 1 can be bonded by thermal bonding to form the partition weak seal portion 20.

    The pressure required to open the weak seal portion 20 is an internal pressure generated when the medical multi-chamber container is pressed with a force of, for example, about 5 kg to about 10 kg.

  In addition, the medical multi-chamber container 1 shown in FIG. 2 is a small container that is further separated into one of the internal drug solution storage units 10 and 11 having a large interior and divided into two chambers. The storage chamber 12 is provided, and the medicine c is stored therein, and the seal portion 21 of the small storage chamber 12 is similarly a weak seal portion.

    In the figure, reference numeral 19 denotes an adhesive portion between the small storage chamber 12 and the container main body 3, and is provided as necessary so that the small storage chamber 12 can be opened together when the storage portions 10 and 11 of the container main body are opened. It is what

    As the material of the film constituting the small housing chamber 12, various resins such as a thermoplastic resin such as polyethylene, polypropylene, and polystyrene can be adopted. Further, a thin layer film made of a thermoplastic resin is used for weak interlayer adhesion. It is formed of a film laminated with strength, and is pulled by an opening operation when the weak seal portion 20 of the container body 3 is opened, and the small storage chamber 12 is opened and communicated with the other storage portions 10 and 11 with delamination of these films. You can also make it.

  The medical multi-chamber container 1 is folded into two as shown in FIG. 3 and FIG. 4 at the weak seal portion 20 portion, and the fold line 4 for folding into two is an odd number of 3 or 3 or more. , And 4c (three in the illustrated example).

    The configuration of the broken lines 4a ... may be five broken lines 4a ... 4e as shown in FIG. 5 or may be an odd number more than that. However, if the number is increased too much, the band where the broken line is provided becomes wider.

    In this way, when folded at an odd number of fold lines, even if a force is applied in the lateral shift direction as indicated by an arrow A in FIG. 6, for example, the fold lines 4a. Absent.

Therefore, even if gravity is applied to the first storage portion 10 and internal pressure is generated, the transmission of pressure is interrupted at the portion of the folding line 4a or 4b, and the weak seal portion 20 that partitions the second storage portion is peeled off. It is prevented from being transmitted as power.
As shown in FIG. 2, at least one fold line (4a) of the medical multi-chamber container 1 in the case where the small storage chamber 12 is provided is located inside the small storage chamber 12 from the weak seal portion 21 of the small storage chamber 12. The bent line 4a prevents the pressure from being transmitted to the seal portion 21 of the small storage chamber 12 as a peeling force.

    Accordingly, unintentional mixing of the medicines in the storage units 10 and 11 or the small storage chamber 12 during storage or the like is reliably prevented.

    And when the main body 3 of the medical multi-chamber container is a bag-like container formed by thermally bonding or adhering the peripheral edge of the synthetic resin film, the odd-numbered broken line is shown in FIG. In this way, the heating blades 5..., Etc. arranged opposite to each other in accordance with the number of fold lines are pressed from the front and back of the weak seal portion 20 of the container body 3 in the directions indicated by the arrows, respectively, or plastically deformed into a fold line shape, As shown, the heating dies 6, 6 having serrated projections 6 a, 6 b, which are in line with each other and are fitted to each other, are pressed by a temperature that does not affect the weak sealing performance of the seal portion 20.

    As a method for storing the medical multi-chamber container, as shown in FIG. 9, the medical multi-chamber container 1 folded in two at odd-numbered folding lines 4a, 4b and 4c is housed in a packaging bag 7 and folded in two. If the posture is forcibly held by the packaging bag 7 and the folding form is not expanded, the pressure blocking effect by the folding lines 4a is reliably maintained even if a slight external force is applied. Here, the packaging bag 7 is shown as a packaging member that forcibly holds the folded posture, but instead of this, it may be a band body that is wrapped around and tightened so as not to expand around the folded container body, and further the adhesive surface It is also possible to use a belt-like adhesive sheet (not shown) such as an adhesive tape wound and adhered to the container body 3 side.

  Next, examples of the medical multi-chamber container according to the present invention will be described.

  As the medical multi-chamber container 1, as shown in FIG. 2, a structure in which a small accommodating chamber 12 is further provided in the first accommodating portion 10 among the first accommodating portion and the second accommodating portion 11 is used. did.

The main body container 3 of the medical multi-chamber container 1 is made of a sheet having a two-layer structure consisting of the following item a, and the periphery thereof is sealed under the conditions shown in the item b below. Sealed under the conditions indicated in the item.
a Sheet material inner layer: Layer made of a mixed resin of polyethylene and polypropylene Outer layer: Layer made of polyethylene Layer thickness: 250 μm
b Peripheral sealing conditions Sealed at 185 ° C. for 4.5 seconds. Width 5mm from the periphery
c Sealing conditions of 137 to 139 ° C. for the partition part (weak seal part) 4.5 seals. 14mm width of partition
The first storage unit 10 was filled with 300 mL of distilled water, and the second storage unit 11 was charged with 700 mL of distilled water.

The small storage chamber 12 is a bag made of a sheet having a three-layer structure consisting of the following items d, and sealed to the inner wall of the first storage material 10 under the following conditions e.
d Inner layer of sheet material in small containment chamber ... Layer made of polyethylene Intermediate layer ... Layer made of polycyclic olefin Outer layer ... Layer made of polyethylene Layer thickness ... 32.5μm
e Sealing condition for the inside of the first storage chamber Sealing for 2.7 at 162 ° C.

    And the inside of a small accommodation chamber was filled with 4 mL distilled water.

    As shown in FIG. 7, the M-shaped three fold lines are plasticized under the temperature conditions that do not affect the sealing performance of the weak seal portion 20, as shown in FIG. Formed by deformation. The medical multi-chamber container 1 is folded in two as shown in FIG. 8, and an adhesive tape is applied and fixed to the outer periphery so that the posture of the folded state does not shift, and the first storage chamber 10 becomes the lower surface. Thus, the state of the weak seal part 20 and the small storage chamber 12 was observed by dropping from a height of 20 cm.

  The results are shown in Table 1 below.

なお、表１における比較例はいずれも図２に示したように小収容室１２を有する医療用複室容器であって、比較例１は図２における折線４ａの一箇所で折り曲げて二つ折りにしたもの、比較例２は図２における折線４ｃ部分の一箇所で折り曲げて二つ折りにしたものである。

In addition, all the comparative examples in Table 1 are medical multi-chamber containers having the small storage chambers 12 as shown in FIG. 2, and the comparative example 1 is folded at one place on the folding line 4a in FIG. In Comparative Example 2, the folding line 4c in FIG.

  As is apparent from the results in Table 1, according to the present invention, it was confirmed that there was no accident such as separation or opening of the weak seal portion 20 for partitioning or rupture of the small storage chamber 12 and safe storage.

It is a perspective view of the medical multiple-chamber container of this invention. It is an explanatory top view which shows the medical multiple chamber container which has a small storage chamber. It is sectional drawing of the state folded into two of the medical multiple-chamber container of this invention. It is a principal part expanded sectional view of FIG. It is principal part sectional drawing which shows the other structural example of the broken line part of the medical multiple-chamber container of this invention. It is sectional drawing which shows the action | operation of a broken line part. It is explanatory sectional drawing which shows the process of attaching a broken line. It is explanatory sectional drawing which shows the other process which attaches a broken line. It is sectional drawing which shows the accommodation method of a medical multi-chamber container. It is an explanatory top view of the conventional medical multi-chamber container. It is the XX sectional view taken on the line of FIG. It is explanatory sectional drawing of the folding structure of the conventional medical multi-chamber container. It is explanatory sectional drawing which shows the change state of the folding part of the conventional medical multiple chamber container.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 ... Medical multi-chamber container 2 ... Peripheral part 3 ... Container main body 4 ... Folding line 4a ... Folding line 4b ... Folding line 4c ... Folding line 6 ... Heating type 7 ... Packaging member 10 ... 1st accommodating part 11 ... 2nd accommodating part 12 ... Small Storage chamber 19 ... Adhesive part 20 ... Weak seal part 31 ... Drug outlet

Claims (10)

A container main body having a plurality of storage portions; and a medicine discharge port connected to the storage portion, and the container main body is divided into the plurality of storage portions and is opened to communicate with each other by increasing the pressure in the storage portion. A multi-chamber container for medical use in which the container body is folded in two at the partition part, and the fold line part for folding the container body is folded back in a zigzag shape by plastic deformation. A medical multi-chamber container comprising three or more odd-numbered broken lines.   2. The small storage chamber is provided in at least one of the storage units, and the plurality of storage units and the small storage chamber are all opened and communicated with each other by increasing the pressure in the storage unit. The medical multi-chamber container as described.   The medical multi-chamber container according to claim 1 or 2, wherein the number of folding lines folded at the folding portion of the container body is three.   The container body is formed of a film made of a mixed material of polyethylene and polypropylene, and the partition portion is formed by thermally bonding film surfaces on both sides of the container body. The medical multi-chamber container according to any one of the above.   The medical multi-chamber container according to any one of claims 2 to 4, wherein the small storage chamber is formed of a film of a thermoplastic resin such as polyethylene, polypropylene, or polystyrene.   The small storage chamber is formed of a film obtained by laminating a thin film made of a thermoplastic resin such as polyethylene, polypropylene, polystyrene, etc., with an adhesive strength that facilitates delamination, and is opened and communicated with the delamination. The medical multi-chamber container according to any one of claims 2 to 4.   The container main body according to any one of claims 1 to 6, wherein a chevron-shaped heating mold having serrated protrusions that fit each other is pressed from the front and back surfaces of the partition part that is not yet provided with a fold line, A method for producing a medical multi-chamber container comprising heating at a temperature that does not affect the opening communication function of the partition part of the main body, and plastically deforming the partition part of the container into three or more odd-numbered broken lines folded back in a zigzag manner .   The container body according to any one of claims 1 to 6, wherein the blades that are arranged opposite to each other in accordance with the number of fold lines are pressed from the front and back surfaces of the partition sections that are not yet provided with fold lines. A method for producing a medical multi-chamber container, wherein the container is heated at a temperature that does not affect the communication function and plastically deformed into three or more odd-numbered broken lines folded back in a zigzag manner on the partition portion of the container.   A container main body having a plurality of storage portions; and a medicine discharge port connected to the storage portion, and the container main body is divided into the plurality of storage portions and is opened to communicate with each other by increasing the pressure in the storage portion. The medical multi-chamber container according to any one of claims 1 to 6, wherein the liquid medicine is stored in at least one of the plurality of storage portions, and the number of odd numbers is 3 or more along the partition portion. A method for storing a medical multi-chamber container, wherein the whole is folded in two through a fold line folded in a zigzag shape and is wrapped with a packaging member from the outer periphery in the folded position.   The method for storing a medical multi-chamber container according to claim 9, wherein the packaging member packaged from the outer periphery in order to forcibly hold the folded posture is a band-like adhesive sheet with an adhesive surface facing the container body. .

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