JP4749057B2 - Multi-chamber infusion container and manufacturing method thereof - Google Patents

Description

  The present invention includes a medical multi-chamber infusion container, and more specifically, a plurality of chambers that individually store various unstable drugs (liquid, powder, or solid) that change with time when mixed simultaneously. The present invention relates to a medical multi-chamber infusion container that can mix a medicine stored in each room in a sterile state without generating foreign matter by peeling off and opening the partition seal.

  A plurality of drugs are mixed and administered to a patient, for example, an amino acid drug or the like is mixed with a glucose solution. In this way, when mixing multiple drugs, depending on the type of drug, it will deteriorate if mixed in advance, so a multiple chamber infusion that can accommodate multiple drugs separately and mix them at the time of use Containers are known. Such a multi-chamber infusion container is formed of a thermoplastic resin film.

  In such a multi-chamber infusion container, when a plurality of medicines are stored separately, the partition portion between the storage chambers is liquid-tightly sealed, and when the plurality of medicines are mixed, the partition portion is easily peeled off. It is necessary that the drug can be opened and the drug can be mixed rapidly. For this reason, many researches have been made on methods for forming such boundary portions.

  For example, there has been proposed a structure in which the partition seal portion is easily peeled by forming the knurled pattern and the flat knurled pattern on both outer surfaces of the partition seal portion (Patent Document 1). .

  However, since both outer surfaces have special shapes, it is necessary to form a heating and pressing plate having a pressing surface with a corresponding shape, which increases equipment costs and adjusts the alignment of the upper and lower heating and pressing plates. In addition, there is a problem that variation in seal strength is increased due to a position shift of the heat seal bar.

  Further, a medical multi-chamber infusion container in which a strong seal portion is dispersed in a weak seal portion to form a partition seal portion has been proposed (Patent Document 2). However, there is a problem that the strong chambers are sewed to flow while the weak seal portions are peeled off to allow the storage chambers to communicate with each other.

  Moreover, although the thing which made the width dimension of the seal part for a partition 1 mm-3 mm was proposed (patent document 3), when a momentary force acts during conveyance etc., there is a problem of opening carelessly. there were.

Furthermore, what set the seal | sticker intensity | strength in two steps is proposed (patent document 4). This technique has the advantage that if it is peeled off at least the one with the weaker sealing strength, the seal strength suitable for peeling and opening the other can be obtained, but it can be prevented from being opened carelessly. However, it is desirable that a more appropriate seal strength can be obtained at the time of opening.
JP-A-8-24314 Japanese Patent Laid-Open No. 2004-476 JP-A-1-240469 JP 2004-121751 A

  The present invention has been made in view of such points, and can provide a double-chamber infusion container that can provide a seal strength that is extremely suitable for opening, and that does not open carelessly when not in use, such as during transportation. It is an object to provide a manufacturing method thereof.

The inventor of the present invention has been completed through intensive studies in order to solve the above problems.
1. A container body formed in a bag shape from a thermoplastic resin film, a plurality of storage chambers capable of storing a medicine, and an easily peelable partition seal portion for partitioning the plurality of storage chambers, the partition seal portion In the multi-chamber infusion container formed so as to fuse the inner surfaces of the film and peel and open by an external pressure applied to the storage chamber in use, the partition seal portion has a predetermined interval. It has a plurality of seal strips provided and arranged, each seal strip is continuous from one side edge to the other side edge of the container body, and the width dimension of each seal strip is 0.1 to 2 mm A multi-chamber infusion container characterized by being set to be provided.
2. 2. The multi-chamber infusion container according to 1 above, wherein the number of seal strips is 2 to 10.
3. 3. The multi-chamber infusion container according to 1 or 2 above, wherein the partition seal part has a seal strength of 0.1 to 0.7 kg / 15 mm.
4). 4. The multi-chamber infusion container according to any one of 1 to 3, wherein the plurality of seal strips are set to have substantially the same width.
5. The inner surfaces of the film located between the seal strips are fused with a strength lower than the seal strength of the seal strip to form a weak auxiliary seal portion. A multi-chamber infusion container according to any one of the above.
6). The multi-chamber infusion container according to any one of 1 to 5 above, wherein the seal strip is formed in a straight line shape, a wave shape, a sawtooth shape, or a combination of these shapes in a plan view.
7). The multi-chamber infusion container according to any one of 1 to 6 above, wherein the auxiliary seal portion is formed in a dotted shape in the partition seal portion other than the seal strip.
8). In order to form a plurality of storage chambers in which a medicine can be stored in a container body formed in a bag shape from a thermoplastic resin film, the container body includes a step of forming an easily peelable partition seal portion, The partition seal part having a plurality of continuous seal strips from one side edge part to the other side edge part of the container body is formed by sandwiching the two films to be heat-sealed by a heat seal bar. And the width dimension of each seal | sticker strip part is set to 0.1-2 mm, and easy peelability is provided, The manufacturing method of the multi-chamber infusion container characterized by the above-mentioned is provided.
9. The above-mentioned heat sealing condition by the heat seal bar is as follows: the heating temperature is 114 to 120 ° C., the fusion pressure is 0.2 to 0.3 MPa, and the heating time is 3 to 4 seconds. A method for producing the described multi-chamber infusion container is provided.

  According to the present invention, the partition seal portion has a plurality of seal strips disposed at predetermined intervals, and each seal strip extends from one side edge to the other side edge of the container body. Continuously, since the width dimension of each seal strip is set to 0.1 to 2 mm, a relatively small force is continuously applied once the seal strip to which pressure is first applied is peeled off when the partition seal is opened. By continuing to add to the above, the remaining seal strips can be peeled one after another, and a very appropriate seal strength can be obtained for opening the partition seal.

  In addition, if manual pressure or the like is not continuously applied for a certain period of time in the storage chamber, it cannot be opened, and each seal strip is from one side edge to the other side edge of the container body. Since it is continuous, it can be prevented from being carelessly peeled off during various handling such as transportation, and the mixing chemical solution sealed in each compartment can be stored as it is.

  Moreover, since the width dimension of each seal | sticker strip was set to 0.1-2 mm, even if it set to the same seal strength as the outer periphery seal part of a container main body, it will be able to ensure easy peelability and can simplify a manufacturing process. .

  Further, since the setting of the seal strength is facilitated as described above, an easily peelable partition seal portion can be easily formed even with the same resin.

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

  The medical multi-chamber infusion container A includes a container main body 1 having a substantially rectangular shape in plan view, a first storage portion 1a and a second storage 1b arranged side by side in the vertical direction of the container main body 1, and a medicine discharge The first storage portion 1a and the second storage 1b are partitioned by an easily peelable partition seal portion 3. In the first storage portion 1a and the second storage 1b, various kinds of medicines that are undesirable if mixed or dissolved in advance are stored.

  The container main body 1 is formed in a bag shape by thermally sealing the outer peripheral edge portions of two thermoplastic resin films to form the outer peripheral seal portion 4.

The partition seal portion 3 is composed of a plurality of seal strips 5 disposed at predetermined intervals. Each seal strip 5 is continuous from one side edge portion to the other side edge portion of the container body 1, and both end portions of each seal strip portion 5 are continuous with the outer peripheral seal portion 4. In use, the seal strips 5 are peeled off by the external pressure applied to the first storage 1a and / or the second storage 1b, and the partition seal 3 is opened.
The width dimension of each seal | sticker strip part 5 is the same magnitude | size, and is set to 0.1-2 mm, and the width | variety of the seal part 3 for a partition is 5-20 mm. In addition, the number of the seal strips 5 for securing an appropriate seal strength for opening is 2 to 10, preferably 4 to 7.

  The force required to open the partition seal portion 3 per 15 mm length is 0.1 to 0.7 kg / 15 mm, preferably 0.2 to 0.6 kg / 15 mm, more preferably 0.3 to 0.5 kg / 15 mm. If it is less than 0.1 kg / 15 mm, the seal strength is too weak, so it can be opened even with a slight impact. This is because if it exceeds 0.7 kg / mm, the sealing strength is too strong and a large force is required for opening, which increases the burden for opening.

  The manufacturing method of such a medical multi-chamber infusion container A includes a step of forming a container body 1 in a bag shape from a thermoplastic resin film, and a container for forming a plurality of storage chambers capable of storing a drug in the container body 1. A step of forming an easily peelable partition seal portion 3 on the main body 1 is provided.

In the step of forming the partition seal portion 3, the two stacked films constituting the container body 1 are sandwiched between the heat seal bars B, and the films are heat-sealed under predetermined heat-sealing conditions. A plurality of seal strips 5 that are continuous from one side edge to the other side edge of the container body 1 are formed. The heat fusion conditions are a heating temperature of 114 to 120 ° C., a fusion pressure of 0.2 to 0.3 MPa, a heating time of 3 to 4 seconds, and heat fusion for forming the outer peripheral seal portion 4. Same as condition. It should be noted that the heating and fusing time of each seal strip 5 is made shorter than the heating and fusing time of the outer peripheral seal portion 4, and the fusing pressure and heating temperature of each sealing strip 5 are set to the fusing pressure and heating of the heating fusing time. The seal strip 5 can be easily peeled off by lowering the temperature.
The heat seal bar B includes an upper seal bar B1 and a lower seal bar B2 that are opposed to each other, and a seal strip 5 is formed by sandwiching a film at a partition forming portion of the container body 1 between the upper and lower seal bars and thermocompression bonding. Is done. The pressure surface B21 of the lower seal bar is formed flat, and a plurality of protrusions B12 are formed on the pressure surface B11 of the upper seal bar B1. As shown in FIG. 4, a weak auxiliary seal portion 7 having a sealing strength smaller than that of the seal strip portion 5 is formed between the seal strip portions 5 by the heat seal bar B. In addition, you may form the weak auxiliary | assistant seal | sticker part 7 using the heat | fever of heat sterilization.
It is preferable to set the area ratio of the seal strip 5 in the area of the partition seal 3 to 1 to 80%. In addition, the area of the partition seal part 3 is the sum of the area of each seal strip 5 and the area of the weak auxiliary seal part 7 therebetween.
In addition, you may form the seal strip (illustration omitted) which does not continue from the one side edge part of the container main body 1 to the other side edge part between the above-mentioned several seal strip parts 5 or seal seal part 5 vicinity.
5 and 6 show other forms of the partition sealing portion 3. FIG. 5 shows a shape in which each seal strip 5 is formed in a wave shape or a sawtooth shape in plan view, and FIG. 5 (c) shows a mode in which auxiliary seal portions 6 are formed in the form of dots around each seal strip 5. Show. In addition, the seal strength of the auxiliary seal portion 6 arranged in the form of dots is not particularly limited as long as the seal strength appropriate for opening is secured. FIG. 6 shows a form in which the width of each seal strip 5 is changed. In FIG. 6A, the seal strip 5 located at the center is set to the maximum width, and the width dimension is increased toward the outside. This is narrowed, and this is repeated in FIG.

  The thermoplastic resin film used for the multi-chamber infusion container of this example can be used without any particular limitation, but a polyolefin resin is preferred from the balance of price and physical properties (transparency, flexibility, etc.). For example, high density polyethylene, medium density polyethylene, high pressure method low density polyethylene, low density polyethylene, linear low density polyethylene, polyethylene-based resins such as ethylene-vinyl acetate copolymer, and olefins such as ethylene-butene random copolymer Examples thereof include polypropylene resins such as polypropylene elastomer, polypropylene, ethylene-propylene random copolymer, α-olefin ethylene-propylene random copolymer, and mixtures thereof. In addition, according to such a multi-chamber infusion container, it can be used without particular limitation as long as it is used in the medical field as a thermoplastic resin film, such as vinyl chloride, ethylene vinyl acetate copolymer, polyether. Styrene, cyclic polyolefin, cyclic polyolefin copolymer, styrene elastomer such as hydrogenated styrene ethylene butadiene copolymer, a mixture of these resins, and a film made of these and the above polyolefin resins can also be used. . These resins may be partially crosslinked for the purpose of improving heat resistance.

  Furthermore, the thermoplastic resin film used may be a single layer film made of one kind of film or a multilayer film in which plural kinds of films are laminated. In the case of a single layer film, linear low density polyethylene, polypropylene, propylene ethylene random copolymer, propylene ethylene block copolymer, mixture of propylene resin and ethylene elastomer because of excellent transparency and flexibility, A film such as a mixture of a propylene resin and a styrene elastomer is preferred. In the case of a multilayer film, high density polyethylene / linear low density polyethylene, medium density polyethylene / low density polyethylene / high density polyethylene, high density polyethylene / low density polyethylene / high density polyethylene, etc. The thing can be illustrated.

  Moreover, in a multilayer film, the inner layer may be comprised from the resin composition which enables an easy peel.

  Furthermore, it does not specifically limit about the manufacturing method of a film, The manufacturing method by T die method, water-cooled inflation molding, blow molding, lamination molding, etc. is mentioned. From the viewpoint of transparency, the T-die method and water-cooled inflation molding are preferable.

  Moreover, as a thermoplastic resin film, the thickness of 5-1000 micrometers, Preferably about 50-500 micrometers is used.

  A 300 μm-thick film made of linear low-density poly-ethylene (MFR = 2 g / 10 min (190 ° C.), density 920 kg / m 3) was formed by a water-cooled inflation method. Two sheets of this film were stacked, and the film was sandwiched from both sides with a heat seal bar B to form five seal strips 5 in parallel. In addition, the width dimension of the seal part 3 for a partition is 14 mm, and the width dimension of the seal strip part 5 is 0.5 mm.

  The measurement of the seal strength was performed according to ASTM F88. As shown in FIG. 1, a part of the medical multi-chamber infusion container A is cut out so that the length L of the partition seal part 3 is 15 mm, and the cut piece B is sandwiched between the non-molten parts in the jig of the tensile tester. The sealing strength was measured by pulling the film of the cut piece B at a speed of 200 mm / min and peeling off the partition sealing portion 3. The fusing conditions were a heating time of 3.4 seconds and a fusing pressure of 0.3 MPa, and the heating temperature was measured in a plurality of stages. 7 and 8, it was found that the most convenient seal strength can be obtained as the easily peelable partition seal portion 3 when the heating temperature is around 117 ° C. FIG. 8 is an enlarged view of a part of FIG.

It is a perspective view which shows embodiment of the multi-chamber infusion container which concerns on this invention. It is a top view which shows the same embodiment. It is a perspective view of a heat seal bar. It is XX sectional drawing of FIG. It is a top view which shows the other form of the seal part for a partition. It is a top view which shows the other form of the seal part for a partition. It is a graph which shows the relationship between sealing temperature (heating temperature) and adhesive strength (seal strength). FIG. 8 is a partially enlarged view of FIG. 7.

Explanation of symbols

A medical multi-chamber infusion container 1 container main body 1a first storage part 1b second storage part 3 partition seal part 4 outer periphery seal part 5 seal strip

Claims (9)

A container body formed in a bag shape from a thermoplastic resin film, a plurality of storage chambers capable of storing a medicine, and an easily peelable partition seal portion for partitioning the plurality of storage chambers, the partition seal portion Is a multi-chamber infusion container formed by fusing the inner surfaces of the film and peeling and opening by external pressure applied to the storage chamber in use,
The partition seal portion has a plurality of seal strips arranged at predetermined intervals, and each seal strip is continuous from one side edge to the other side of the container body, and each seal strip Set the width dimension of the part to 0.1-2 mm,
Auxiliary seal part is formed in a dotted shape in the partition seal part other than the seal strip ,
The auxiliary seal portion is formed to be openable, and is formed from one side edge portion to the other side edge portion of the container body along the seal strip portion .   2. The multi-chamber infusion container according to claim 1, wherein the plurality of seal strips are set to a maximum width with respect to the seal strip located at the center, and the width is narrowed toward the outside.   The multi-chamber infusion container according to claim 1, wherein the plurality of seal strips are set to have substantially the same width. A container body formed in a bag shape from a thermoplastic resin film, a plurality of storage chambers capable of storing a medicine, and an easily peelable partition seal portion for partitioning the plurality of storage chambers, the partition seal portion Is a multi-chamber infusion container formed by fusing the inner surfaces of the film and peeling and opening by external pressure applied to the storage chamber in use,
The partition seal portion has a plurality of seal strips arranged at predetermined intervals, and each seal strip is continuous from one side edge to the other side of the container body, and each seal strip Set the width dimension of the part to 0.1-2 mm,
The plurality of seal strips that form the partition seal portions that partition the plurality of storage chambers are set to have a maximum width of the seal strip located in the center, and the width dimension is narrowed toward the outside. Multi-chamber infusion container.   The inner surface of the film located between the seal strips is fused with a strength lower than the seal strength of the seal strip to form a weak auxiliary seal portion. 5. The multi-chamber infusion container according to any one of 4 above.   The multi-chamber infusion container according to any one of claims 1 to 5, wherein the seal strip is formed in a straight line shape, a wave shape, a sawtooth shape, or a combination of these shapes in a plan view. In order to form a plurality of storage chambers capable of storing a drug in a container body formed in a bag shape from a thermoplastic resin film, the container body includes a step of forming an easily peelable partition seal portion,
The partition seal part having a plurality of continuous seal strips from one side edge part to the other side edge part of the container main body by sandwiching and heat-sealing the two films to be stacked with a heat seal bar. Forming, setting the width dimension of each seal strip to 0.1 to 2 mm to give easy peelability,
Auxiliary seal part is formed in a dotted shape in the partition seal part other than the seal strip ,
The auxiliary seal part is formed so as to be openable, and is formed from one side edge part to the other side edge part of the container body along the seal strip part .   8. The multi-chamber infusion container according to claim 7, wherein the seal strip is set to a maximum width with respect to the seal strip located in the center and narrows toward the outside. In order to form a plurality of storage chambers capable of storing a drug in a container body formed in a bag shape from a thermoplastic resin film, the container body includes a step of forming an easily peelable partition seal portion,
The partition seal part having a plurality of continuous seal strips from one side edge part to the other side edge part of the container main body by sandwiching and heat-sealing the two films to be stacked with a heat seal bar. Forming, setting the width dimension of each seal strip to 0.1 to 2 mm to give easy peelability,
The plurality of seal strips that form the partition seal portions that partition the plurality of storage chambers are set to the maximum width of the seal strip located at the center, and the width dimension is narrowed toward the outer side so that easy peeling is achieved. A method for producing a multi-chamber infusion container, comprising:

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