JP2008173316A - Medical container - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a medical container for preventing a medical worker from forgetting the mixing of medical agents. <P>SOLUTION: This medical container 1 is provided with a first medical agent 7 filling a first medical agent chamber partitioned with a partition section 9, a second medical agent 8 stored in a second medical agent chamber 6, a medical container body 2 having a discharge port 3 with an outlet 35 communicated with a medical agent chamber, and a discharge port covering member 4 detachably attached to the medical container body 2. The discharge port 3 has a tubular section 31 storing a third medical agent 33, a fracturable section 34 provided in the tubular section 31, the outlet 35 having a sealing section 36 closing the other end side of the tubular section 31, and a member connection prevention section 37 for medical agent discharge for preventing a connection allowing the outflow of the medical agent, of the medical agent discharge member to the discharge port 3 when the fracturable section 34 is non-fractured. The discharge port covering member 4 regulates the fracture of the fracturable section 34 and, when the medical container body 2 is pushed, releases the regulation of the fracture of the fracturable section 34. <P>COPYRIGHT: (C)2008,JPO&INPIT

Description

  The present invention relates to a medical container capable of preparing and blending a drug in a drug solution such as an infusion solution.

  In infusion, two or more kinds of liquids (chemical solutions) may be mixed and used. In this case, conventionally, two separately prepared chemicals are prepared by mixing at the time of use. In recent years, by separating the drug chamber of one medical container into two drug chambers by means of a detachable partition, by making the administration of the drug solution prompt and preventing forgetting mixing, etc. In addition, there are some which are separated into two or more chambers by attaching a drug container which can be communicated with the inside of the container main body by being broken at the breakable portion. And in such a multi-chamber container, the medicine which changes and deteriorates with time when separated in advance is separated and stored. However, in the case of such a multi-chamber medical container, the drug flows out when the medical container is punctured with the drug discharge needle tube of the infusion set without opening the partition part or breaking the breakable part. .

  What is shown in patent document 1 (Unexamined-Japanese-Patent No. 2005-305136) is disclosed. In this medical multi-chamber container, a container main body provided with a multi-chamber storage chamber for storing medicines and a partition sealing portion for partitioning each storage chamber, and a medicine attached to the container main body for discharging the medicine from the storage chamber. And the partition sealing portion is configured to be openable so as to allow the storage chambers to communicate with each other in use, and is attached to the drug discharge portion to block the opening. The unsealing prevention member is provided, and the unsealing prevention member holds the body part that closes the opening, the pair of sandwiching parts that are connected to the body part and sandwich the storage chamber, and the sandwiched state of the pair of sandwiching parts Holding means, and when the pressure in the storage chamber increases, the holding state by the holding means is released, and the unsealing preventing member can be detached from the medicine discharge portion.

JP-A-2005-305136

In the thing of the said patent document 1, two types of chemical | medical agents which cannot be mixed beforehand are accommodated in the different storage chambers by the partition sealing part. However, it may be necessary to mix and administer another small amount of drug. In this case, it is necessary to mix a small amount of drug stored in another container such as a vial using a syringe with a syringe. There is. Some medical containers include a medicine container that contains a small amount of medicine in order to reduce the mixed injection work as described above. This type of medical container contains three types of drugs individually, and it is necessary to prevent each drug from being administered alone and in an unmixed state. There was no current situation.
Therefore, an object of the present invention is to solve the above-mentioned problems, preventing forgetting to mix before administration of two types of drugs stored in two drug chambers separated by a detachable partition, And while enclosing a small amount of medicine in the discharge port, it is possible to prevent the single administration and unmixed administration of the small amount of medicine stored in this discharge port, and also during non-administration work such as transportation It is an object of the present invention to provide a medical container that can prevent communication between a discharge port and a drug room (a drug out of a discharge port into a drug room).

What achieves the above object is as follows.
(1) a first medicine divided into a first medicine chamber and a second medicine chamber by a partition formed by a peelable seal portion, and filled in the first medicine chamber; A soft medical container body comprising: a second medicine housed in two medicine chambers; and a discharge port having a discharge port that communicates with any one of the drug chambers and allows connection of a medicine discharge member; A medical container comprising a discharge port encapsulating member detachably attached to a medical container body,
The discharge port is closed at one end side and opened at the other end side, and has a cylindrical portion having a drug storage portion therein, and is provided in the cylindrical portion, and can communicate with the drug chamber of the drug storage portion by breaking. The breakable portion, the other end side of the cylindrical portion, the discharge port having a sealing portion that can be connected to the medicine discharge member, and the breakage provided in the cylindrical portion A medicine discharge member connection inhibiting portion that inhibits connection of the medicine discharge member to the discharge port when the possible portion is not broken, and a third medicine stored in the drug storage portion; It is prepared
The discharge port encapsulating member regulates breakage of the breakable portion of the discharge port and can be broken by pressing the medical container body to release the partition portion of the medical container body A medical container in which the restriction of breakage of the part is released.

(2) The discharge port includes an operation portion for performing a breaking operation of the breakable portion, and the discharge port encapsulating member regulates a breaking operation of the operation portion. Medical containers.
(3) The medical container according to (1) or (2), wherein the discharge port encapsulating member includes a mounting portion to the medical container main body.
(4) The discharge port encapsulating member includes the opposing expansion force receiving portions for receiving the expansion force of the medical container body when the medical container is pressed. The medical container in any one.
(5) The discharge port encapsulation member according to any one of (1) to (4), wherein the sealing portion of the discharge port is exposed when the member is attached to the medical container body. Medical container.
(6) The medical container body according to any one of (1) to (5), wherein the medical container main body includes a peelable communication-inhibiting weak seal portion that inhibits communication between the drug chamber and the discharge port. Medical container.

According to the medical container of the present invention, the two kinds of medicines stored in the two medicine chambers separated by the detachable partition portion are prevented from being administered without being mixed, and the discharge port In addition, it prevents the small amount of medicines contained in the medicine from being administered alone or in an unmixed state. Furthermore, communication between the discharge port and the medicine chamber during non-administration work such as transportation (the medicine chamber of the medicine in the discharge port) Outflow).
Furthermore, the breakable portion of the discharge port in which the third medicine is stored is protected by the discharge port encapsulating member, and the discharge port encapsulating member is used for medical purposes to release the partition portion of the medical container body. The protection of the breakable portion is released by pressing the container body. For this reason, before the medicine in the first chamber and the medicine in the second chamber are mixed, that is, before the partition portion is released, the first chamber and the discharge port are in communication and ready for administration (in other words, Only the medicine in the first chamber and the medicine in the discharge port are mixed to be ready for administration). Moreover, since the state in which the breakable portion is protected is maintained by the protective member until the medicines in the first chamber and the second chamber are mixed, the partition part is peeled off (the medicine in the first chamber and the second chamber are separated). The mixing order of the drugs is always maintained: mixing of the drugs) and breaking of the breakable part (mixing of the third drug in the discharge port into the mixture of the drug in the first chamber and the drug in the second chamber).

Hereinafter, the medical container of the present invention will be described in detail with reference to the accompanying drawings.
FIG. 1 is a front view of an embodiment of the medical container of the present invention. FIG. 2 is a cross-sectional view of the medical container of FIG. 1 taken along line AA. FIG. 3 is a front view of an example of a discharge port encapsulating member used in the medical container shown in FIG. FIG. 4 is a left side view of the discharge port encapsulating member of FIG. FIG. 5 is a plan view of the discharge port encapsulation member of FIG. FIG. 6 is a bottom view of the discharge port encapsulating member of FIG. FIG. 7 is a front view of a state in which the discharge port encapsulating member of FIG. 3 is developed. 8 is a rear view of the state in which the discharge port encapsulating member of FIG. 3 is developed. FIG. 9 is a front view of an embodiment of the discharge port used in the medical container shown in FIG. 10 is a cross-sectional view of the discharge port of FIG. 11 is a cross-sectional view of the discharge port of FIG. 9 taken along the line BB. 12 and 13 are explanatory diagrams for explaining a method of using the medical container shown in FIG.

The medical container 1 of the present invention is divided into a first drug chamber 5 and a second drug chamber 6 by a partition portion 9 formed by a peelable seal portion, and is filled in the first drug chamber 5. The first medicine 7, the second medicine 8 accommodated in the second medicine chamber 6, and a discharge port having a discharge port 35 that communicates with one of the drug chambers and allows connection of a medicine discharge member. 3, a soft medical container main body 2 including a discharge port encapsulating member 4 detachably attached to the medical container main body 2.
The soft medical container body 2 includes a soft bag 2a and a discharge port 3 attached to the soft bag 2a.
As shown in FIGS. 9 to 11, the discharge port 3 includes a cylindrical portion 31 having one end side closed and the other end side opened and a medicine storage portion 32 therein, and a medicine storage in which a third medicine 33 is stored. A cylindrical part 31 having one end closed, a breakable part 34 provided on the cylindrical part 31 and capable of communicating with the medicine chamber of the medicine storage part 32 by breaking; A discharge port 35 having a sealing portion 36 that closes the end side and can be connected to a medicine discharge member, and a discharge port 3 provided in the tubular portion 31 when the breakable portion 34 is not broken. A medicine discharge member connection inhibition unit 37 that inhibits the connection of the medicine discharge member into a medicine outflowable state and a third medicine 33 stored in the medicine storage unit 32 are provided. Then, the discharge port encapsulating member 4 is broken by pressing the medical container body 2 in order to restrict the breakage of the breakable portion 34 of the discharge port 3 and to release the partition portion 9 of the medical container body 2. The restriction of breakage of the possible portion 34 is released.

The soft bag 2a of the medical container body 2 is made of a soft synthetic resin. The flexible bag 2a is preferably formed into a cylindrical shape by an inflation molding method. The soft bag 2a may be manufactured by various methods such as a blow molding method and a coextrusion inflation method.
Examples of the material for forming such a flexible bag 2a include polyvinyl chloride, polyamide, polyester, polyethylene (PE), polypropylene (PP), polybutadiene, ethylene-vinyl acetate copolymer (EVA), polyolefin, and olefin. Examples thereof include various thermoplastic elastomers such as styrene-based elastomers and styrene-based elastomers, and those arbitrarily combined (blend resin, polymer alloy, laminate, etc.). And it is preferable that the resin material to be used has the heat resistance and water resistance which can endure high pressure steam sterilization (autoclave sterilization).
Moreover, when polyolefin is contained as a forming material of the soft bag 2a, the usefulness of the present invention is great. Therefore, in this invention, it is preferable that polyolefin is included as a forming material of the flexible bag 2a. As a material for forming the flexible bag 2a, polyethylene, polypropylene, styrene-based thermoplastic elastomer such as styrene-butadiene copolymer or styrene-ethylene-butylene-styrene block copolymer, or ethylene-propylene copolymer is particularly preferable. And a soft resin obtained by blending and softening an olefinic thermoplastic elastomer such as an ethylene-butene copolymer or a propylene-α-olefin copolymer. This material is preferable in that it has high strength and flexibility, heat resistance (particularly heat resistance during sterilization) and water resistance, and is particularly excellent in workability and can reduce manufacturing costs.

In addition, the soft bag 2a may have a single-layer structure (single-layer body) made of the material as described above, and a plurality of layers (particularly layers of different materials) are stacked for various purposes. It may be a multilayer laminate. In the case of a multilayer laminate, a plurality of resin layers may be stacked, or a metal layer may be stacked on at least one resin layer. In the case where a plurality of resin layers are stacked, the advantages of the respective resins can be provided together. For example, the impact resistance of the soft bag 2a can be improved, or blocking resistance can be imparted. Moreover, in the case of a thing with a metal layer, the gas barrier property etc. of the soft bag 2a can be improved. For example, when a film such as an aluminum foil is laminated, the gas barrier property can be improved and the light shielding property can be imparted. In addition, when a layer made of an oxide such as titanium oxide, aluminum oxide, or silicon oxide is formed, the gas barrier property can be improved and the transparency of the flexible bag 2a can be maintained to ensure the internal visibility. Can do. In addition, when the soft bag 2a is a multilayer laminated body, it is preferable that the material which forms the inner surface part is the material mentioned above.
The soft bag 2a is produced by blow molding using the resin, is formed by fusing the peripheral portions of two sheets formed of the resin, and is formed of one sheet of the resin. Any of the one formed by folding the sheet and fusing the peripheral edge part, or the one formed by extrusion molding using the above resin and fusing the peripheral edge of the opening may be used. One sheet or the other sheet constituting the soft bag 2a referred to in the present invention is either the front sheet or the back sheet constituting the soft bag 2a.

As shown in FIG. 1, an upper end side seal portion 21 and a lower end side seal portion 22 are provided at the upper end portion and the lower end portion of the medical container body 2. The upper end side seal portion 21 and the lower end side seal portion 22 are wide and strong seal portions. The upper end side seal portion 21 is provided with a mixed injection port attachment portion 23 for attaching the mixed injection port 11, and the lower end side seal portion 22 is formed with a discharge port attachment portion 24 for attaching the discharge port 3. Yes. The mixed injection port attachment portion 23 and the discharge port attachment portion 24 are formed by not sealing a part of the upper end side seal portion 21 and the lower end side seal portion 22.
The partition portion 9 of the embodiment peels off when the first drug chamber 5 or the second drug chamber 6 is strongly pressed (when squeezed), thereby separating the first drug chamber 5 and the second drug chamber 6 from each other. It can communicate.

The seal strength of the partition portion 9 is preferably such that it does not peel off by the pressure applied to the medical container body 2 during transportation but peels when the medical container body 2 is strongly pressed with a finger or the like. . The partition portion 9 is preferably formed by fusing the medical container body 2. The fusion is preferably heat fusion, high frequency fusion or the like. Since the medical container body 2 has the two drug chambers 5 and 6 divided into the partition portions 9 in this way, drugs of different components can be mixed aseptically in the medical container body 2. Can do. Further, in the embodiment shown in FIG. 1, the partition portion 9 is provided in a straight line horizontally with respect to the medical container body 2, but is not limited thereto. Moreover, it is preferable that the strong seal part 9a which cannot be peeled substantially is formed in the both ends of the partition part 9. FIG.
The seal strength (initial peel strength) of the partition portion 9 is preferably 0.1 to 25 N / 10 mm, and more preferably 0.3 to 20 N / 10 mm. If the seal strength is within this range, the weak seal part of the partition part 9 is not accidentally peeled off during transportation or storage, and the work of peeling the partition part 9 is easy.

  The first drug chamber 5 and the second drug chamber 6 of the medical container main body 2 store the first drug 7 and the second drug 8 respectively. The drug chambers 5 and 6 preferably contain different components. As such an infusion, for example, two or more solutions such as peritoneal dialysis solution, transcentral vein infusion, transperipheral vein infusion, transperipheral vein injection, liquid nutrient, etc. Those that need to be mixed are preferred. Examples of the infusion include physiological saline, electrolyte solution, Ringer's solution, high calorie infusion, glucose solution, water for injection, amino acid electrolyte solution, and the like, but are not limited thereto. For example, a glucose electrolyte solution is stored in one of the drug rooms, and an amino acid solution is stored in the other, and water-soluble vitamins such as vitamin B1, vitamin B2, vitamin B6, vitamin C, panthenol, and nicotinamide are stabilized in both chambers. Can be appropriately sorted and stored. In this case, a high-calorie total infusion containing total vitamins is provided by storing liquids mainly composed of fat-soluble vitamins such as vitamin A, vitamin D, vitamin E, vitamin K, etc. in a drug container (discharge port) attached to the drug room described later. It can be used as an agent.

The thickness of the sheet material constituting the flexible bag 2a is appropriately determined according to the layer configuration and the characteristics of the material used (flexibility, strength, water vapor permeability, heat resistance, etc.), and is not particularly limited. Usually, the thickness is preferably about 100 to 500 μm, and more preferably about 200 to 360 μm.
Moreover, the upper end side seal part 21 of the medical container main body 2 is provided with a hole 25 (hanging part) for hanging on a hanger or the like.
The volume ratio between the first drug chamber 5 and the second drug chamber 6 divided by the partition portion 9 is preferably 8: 1 to 1:20, and particularly the volume ratio is 4: 1 to 1: 5 is preferable.

The volume of the first medicine chamber 5 of the medical container 1 should be small. If it is such a structure, when the 2nd chemical | medical agent chamber 6 is pressed, it will become easy to open the partition part 9 and the discharge port encapsulation member 4 by one action. In addition, the amount of fluid to be filled [including the medicine and the head space (gas)] is 20 to 50% by volume of the total capacity of the medical container (the capacity in a state where the partition portion 9 is peeled to be one chamber). The effect of the present invention becomes more remarkable. In medical containers such as infusion bags, other drugs are mixedly injected. For this reason, bags for medical use are made in anticipation of a reserve capacity of the same amount to several times the amount of fluid to be filled. The amount of fluid in the medical container having the partition portion 9 is 20 to 50% by volume. However, even with such a small liquid filling amount, according to the present invention, the partition portion 9 and the discharge port encapsulating member 4 are separated. Can be opened.
Specifically, the volume of the first drug chamber 5 is preferably about 20 to 3000 ml, and particularly preferably 50 to 2000 ml. The volume of the second medicine chamber 6 is preferably about 20 to 3000 ml, and particularly preferably 50 to 2000 ml.

  In this embodiment, an appropriate amount of the third medicine 33 is accommodated in the discharge port 3 as shown in FIG. Moreover, it is preferable that the formation part of the chemical | medical agent storage part 32 of the discharge port 3 is transparently formed so that an internal chemical | medical agent can be visually observed. The medicine to be stored may be any powder, granule or other solid form or liquid form. Examples of drugs include those that are mixed and dissolved in infusions. For example, antibiotics, vitamins (such as total vitamins or fat-soluble vitamins), various amino acids, antithrombotics, insulin, antitumor agents, analgesics Agents, cardiotonic agents, intravenous anesthetics, anti-parkinsonian agents, ulcer treatment agents, corticosteroid agents, arrhythmic agents, correction electrolytes, antiviral agents, immunostimulants, and the like. Moreover, although the inside of the cylindrical part 31 (medicine storage part 32) of the discharge port 3 may be a normal pressure, it is good also as a pressure reduction or a vacuum state. Thus, when the medicine container 32 is in a reduced pressure or vacuum state, the effect of preventing degradation, degradation, etc. of the medicine 33 is improved, and when the breakable portion 34 is broken, the infusate is sucked in more quickly. It can be introduced into the cylindrical portion 31.

As shown in FIG. 10, the discharge port 3 is provided in the cylindrical portion 31 having one end side closed and the other end opened and having a drug storage portion 32 therein, and the drug storage portion 32 by breakage. The breakable portion 34 that enables communication with the first drug chamber 5 and the discharge of a drug such as a so-called infusion set that closes the other end side of the cylindrical portion 31 and includes a bottle needle, a tube, and a puncture needle A discharge port 35 having a sealing portion 36 to which a member (not shown) can be connected, and a member for discharging the medicine to the discharge port 3 when the breakable portion 34 is not broken, provided in the cylindrical portion 31. A medicine discharge member connection inhibiting portion 37 that inhibits the connection that allows the medicine to flow out, and a third medicine 33 stored in the medicine storage portion 32 are provided.
In addition, the discharge port 3 of the medical container 1 of the present embodiment includes an operation portion 38 that is connected to the breakable portion 34 and performs a breaking operation of the breakable portion 34.

The breakable portion 34 is a portion where a wedge-shaped annular recess is formed, and is thinner than other portions. For this reason, the breakable portion 34 is weaker than other portions, and by pushing the operation portion 38 from the outside of the container body 2, the breakable portion 34 is broken at the breakable portion 34. Separated from the cylindrical portion 31. And it is preferable that the operation part 38 to isolate | separate is hollow. By doing so, the operation unit 38 rises vigorously, and the medicine in the cylindrical part is immediately mixed with the mixed solution of the first medicine and the second medicine. Moreover, since it becomes preferable as molding conditions, it will be in a state without uneven thickness. The distance between the inner upper surface of the cylindrical portion 31 and the breakable portion 34 is preferably minimized so that the medicine discharge member cannot be connected to the sealing portion before breakage in the breakable portion. 1 to 2 mm is preferable.
Furthermore, you may form this operation part 38 in the color which can be distinguished with respect to the chemical | medical solution after mixing a chemical | medical agent. It can be easily identified from the chemical solution, and the remaining amount of the chemical solution can be easily confirmed because it floats on the chemical surface.
The discharge port 35 has a sealing portion 36 that closes the other end side of the cylindrical portion 31 and can be connected to a medicine discharge member.

In the medical container 1 of this embodiment, a medicine discharge member connection inhibiting portion 37 is accommodated in the discharge port 3. As shown in FIGS. 9 and 10, the medicine discharge member connection inhibition portion 37 in this embodiment includes a distal end portion 37 a that can come into contact with the operation portion 38 (bottom surface of the bottom of the operation portion), and a drug discharge member (for example, It has a base end portion 37b with which the tip of a medicine discharge needle tube such as a bottle needle can abut, and a connecting portion 37c that connects the tip end portion 37a and the base end portion 37b.
When the medicine discharge member is punctured into the sealing portion 36 in a state where the breakable portion 34 is not broken, the tip of the needle abuts on the base end portion 37b of the drug discharge member connection inhibition portion 37, and Even if it is pushed, the medicine discharge member connection inhibiting portion 37 moves upward (upward in the drawing), and after the distal end portion 37a comes into contact with the operation portion 38, it cannot move any more. Further, in this example, the drug discharge member connection inhibiting portion 37 has a distance between the distal end portion 37a and the operation portion 38 (the bottom surface of the bottom of the operation portion) in a state where the base end portion 37b is in contact with the sealing portion 36. Since there is almost no, that is, the distance between the operation portion 38 and the sealing portion 36 in the discharge port 3 and the length of the drug discharge member connection inhibition portion 37 are substantially equal, they cannot move substantially. In addition, as long as the third medicine 33 is configured not to be substantially discharged from the needle punctured in the sealing portion when the breakable portion is in an unbroken state, it is slightly movable in the cylindrical portion. There may be.
And an operator recognizes that the distribution control part is unbroken from the member for medicine discharge being in a puncture impossible state.

The punctureable length of the medicine discharge member into the discharge port when the breakable portion 34 is not broken (state shown in FIG. 9) is such that the opening of the drug discharge member does not communicate with the inside of the discharge port 3. Preferably there is. Therefore, it is preferable that the movable distance within the discharge port 3 of the medicine discharge member connection inhibiting portion 37 is 5 mm or less.
In the medicine discharge member connection inhibiting portion 37 of this example, the tip portion 37a is plate-shaped and disc-shaped, and the tip is hemispherical. By doing in this way, it becomes the shape which is hard to be caught in the inner edge part after the fracture | rupture of the breakable part 34. FIG. Further, the medicine discharge member connection inhibiting portion 37 is provided on the side surface of the connection portion 37c, extends from the appropriate position of the connection portion 37c to the proximal end side, and has a wing portion 37d whose lower end is continuous with the periphery of the proximal end portion 37b. I have. By providing such a wing portion, the base end portion 37b is prevented from being caught by the inner edge portion after the breakable portion 34 is broken. In this example, the wing part 37d extends from the tip part 37a.
The shape of the base end portion 37b is a plate shape or a disc shape, and covers the entire sealing portion. The proximal end portion 37b may have a mesh shape or the like as long as the needle cannot be punctured.
In addition, the medicine discharge member connection inhibition part 37 is not limited to the above type, and may be a cylindrical type with a proximal end closed.

The medicine discharge member connection inhibiting portion 37 in the example described above can flow out from the discharge port 3 after the breakable portion 34 is broken. However, it is not limited to such a thing, and the base end part 37b contacts the upper part (part which was the fracture | ruptureable part 34) of the cylindrical part 31, is locked, and does not flow out from the cylindrical part 31. It may be a thing.
In the case of such a type, it is preferable that the medicine discharge member connection inhibiting portion 37 has an opening at the base end portion 37b in order to ensure the flow of the chemical solution. Examples of the opening include a slit and a through hole. In such a type of medicine discharge member connection inhibiting portion 37 as well, the distal end portion 37a is preferably hemispherical. Moreover, although a wing | blade part may be provided, it is preferable not to provide.

As a forming material of the cylindrical part 31 and the medicine discharge member connection inhibiting part 37, a hard or semi-rigid resin is suitable. As a forming material of the cylindrical portion 31, a material that can be fused to the soft bag 2a by ultrasonic fusion, heat sealing, or the like is preferable. In addition, as a material for forming the cap portion of the discharge port 35, a hard or semi-hard resin is suitable. Further, as a material for forming the cap portion, a material that can be fused to the cylindrical portion 31 by ultrasonic fusion, high frequency fusion, or the like is preferable.
Examples of the material for forming the cylindrical portion 31 and the drug discharge member connection inhibition portion 37 include polyolefins such as polyethylene, polypropylene, and ethylene-propylene copolymers, polyesters such as polyethylene terephthalate and polybutylene terephthalate, and styrene resins such as Polystyrene, MS resin (methacrylate-styrene copolymer), MBS resin (methacrylate-butylene-styrene copolymer), polyvinyl chloride, polyamide, for example, 6 nylon, 66 nylon, etc. are used.

The material for forming the sealing portion (elastic member) 36 is selected from materials that do not cause liquid leakage when a needle is punctured, synthetic rubber (for example, urethane rubber, silicone rubber, butadiene rubber, isoprene rubber, etc.), natural Rubber (for example, latex rubber), styrenic elastomer (for example, styrene-butadiene-styrene copolymer, styrene-isoprene-styrene copolymer, styrene-ethylenebutylene-styrene copolymer, etc.), urethane elastomer (for example, thermoplastic polyether polyurethane) , Thermoplastic polyester polyurethane, etc.) can be used.
Moreover, although the medical container 1 of this Example is provided with the mixed injection port 11 connected to the 2nd chemical | medical agent chamber 6, you may not provide a mixed injection port. A well-known port can be used as the mixed injection port 11.

Next, the discharge port encapsulating member used for the medical container of the present invention will be described.
In this example, the discharge port encapsulating member 4 presses the medical container body 2 in order to release the partitioning part 9, thereby canceling the breakage of the breakable part (encapsulation of the operation part), and the breaking operation. Is possible. Preferably, the medical container body 2 can be detached or detached.
The discharge port encapsulating member 4 of this example is connected to the breakage restricting portions 42a and 42b for restricting breakage of the breakable portion 34 of the discharge port 3 and the medical container body 2 as shown in FIGS. It has a mounting function. Furthermore, the discharge port encapsulating member 4 of this example includes opposing expansion force receiving portions 46a and 46b for receiving the expansion force of the medical container body 2 when the medical container 1 is pressed.
Specifically, the discharge port encapsulating member 4 can bend the first main body portion 4a, the second main body portion 4b, the first main body portion 4a, and the second main body portion 4b that face each other when the medical container main body 2 is mounted. Hinge portions 43a and 43b connected to the.

  The first body portion 4a includes two first body portion side engaging portions 45a and 45b, a breakage restricting portion 42a enclosing the breakable portion of the discharge port and the operation portion, and an expansion force receiving portion 46a. ing. Note that the number of receiving portions for engagement may be only one. Further, the breakage restricting portion 42a preferably encapsulates both the breakable portion and the operation portion of the discharge port as in this embodiment, but it is sufficient that the breakage at the breakable portion can be restricted. For example, the operation portion It is also possible to encapsulate only the ruptureable part. In this example, the first main body side engaging portions 45a and 45b are engaging receiving portions (specifically, engaging window portions). Moreover, the expansion force receiving part 46a is formed in the peripheral part of the fracture | rupture control part 42a. Specifically, the expansion force receiving portion 46a is formed at the peripheral edge portion of the tip side portion of the breakage restricting portion 42a.

  The second body portion 4b includes two second body portion side engaging portions 44a and 44b provided to face the two first body portion side engaging portions 45a and 45b, and a discharge port breakable portion. In addition to encapsulating the operation portion, the breakage restricting portion 42b provided to face the breakage restricting portion 42a of the first main body portion 4a and the expansion force receiving portion 46a of the first main body portion 4a are provided to face each other. An expansion force receiving portion 46b is provided. In addition, the receiving part for engagement may be only one corresponding to 45a or 45b. Further, the breakage restricting portion 42b preferably encapsulates both the breakable portion and the operation portion of the discharge port as in this embodiment, but it is sufficient that the breakage at the breakable portion can be restricted. For example, the operation portion It is also possible to encapsulate only the ruptureable part. In this example, the second main body side engaging portions 44a and 44b are engaging protrusions. Moreover, the expansion force receiving part 46b is formed in the peripheral part of the fracture | rupture control part 42b. Specifically, the expansion force receiving portion 46b is formed at the peripheral edge portion of the tip side portion of the breakage restricting portion 42b. The second main body side engaging portions 44a and 44b serving as engaging protrusions are first main body side engaging portions serving as engaging receiving portions (specifically, engaging window portions). The state where the discharge port encapsulating member 4 is attached to the medical container body 2 is maintained by entering and engaging in 45a and 45b. Therefore, in the discharge port encapsulating member 4 of this example, the mounting function to the medical container main body 2 is achieved by the first main body side engaging portions 45a and 45b and the second main body side engaging portions 44a and 44b. It is configured. In addition, as a mounting mechanism of the discharge port encapsulating member 4, it is preferable that the first main body portion 4a and the second main body portion 4b are engaged by the engaging portion as described above. It is not limited to the type, but may be a type that is directly attached to the discharge port 3. Further, the configuration of the engaging portion is not limited to the above.

Further, as shown in FIGS. 3 to 8, the discharge port encapsulating member 4 includes engaging portion forming portions 41 a and 41 b, which are portions provided with engaging portions, covering the medicine storage portion 32 of the discharge port 3. It is preferable to wrap. By doing in this way, the light-shielding property with respect to the 3rd chemical | medical agent 33 accommodated in the chemical | medical agent storage part 32 can be improved.
As shown in FIGS. 3 to 8, the discharge port encapsulating member 4 of this embodiment includes hinge portions 43a and 43b on the proximal end side, and engagement portions 44a and 43b slightly on the distal end side from the hinge portions 43a and 43b. Engagement portion forming portions 41a and 41b, which are portions provided with 44b, 45a and 45b, are provided, and breakage restricting portions 42a and 42b are provided slightly on the distal end side from the engagement portion forming portions 41a and 41b. The breakage restricting portion encapsulates the breakable portion and / or the operation portion of the discharge port, thereby restricting the breakage operation and / or breakage of the breakable portion and protecting the breakage of the discharge port 3. In this embodiment, the breakage restricting portion restricts breakage operation and breakage of the breakable portion by encapsulating the breakable portion and the operation portion of the discharge port. However, the breakage restricting portion is limited to this. Instead, the breakage restricting portion may restrict the breakage operation or breakage of the breakable portion by encapsulating either the breakable portion or the operation portion of the discharge port.
The discharge port encapsulating member 4 of this embodiment exposes the sealing portion of the discharge port 3 when mounted on the medical container body 2.

The discharge port encapsulating member 4 is pressed when the medical container body 2 is pressed to release the partition 9 of the medical container body 2 and the second medicine 8 flows into the first medicine chamber 5. The restriction of breakage of the breakable portion 34 is released by the pressure. In other words, the operation for breaking the breakable portion 34 is not possible unless the medical container body 2 is pressed to release the partition portion 9.
Further, as described above, the discharge port encapsulating member 4 includes the opposing expansion force receiving portions 46a and 46b for receiving the expansion force when the medical container body 2 is deformed when the medical container body 2 is pressed. It is preferable to provide. The width and area of the expansion force receiving portions 46a and 46b can be set as appropriate.

As the expansion force receiving portions 46a and 46b, in addition to those shown in FIGS. 3 to 8, the length or width of the expansion force receiving portion is adjusted as in the discharge port encapsulation members 54, 64 and 74 shown in FIGS. By doing so, the pressure received by the expansion force receiving portions 46a and 46b when the medical container 1 is pressed may be adjusted.
FIG. 14 is a front view of another embodiment of the discharge port encapsulating member used in the medical container of the present invention. FIG. 15 is a front view of another embodiment of the discharge port encapsulating member used in the medical container of the present invention. FIG. 16 is a front view of another embodiment of the discharge port encapsulating member used in the medical container of the present invention.
The expansion force receiving portions 46a and 46b may have any shape as long as they can receive pressure generated when the medical container 1 is pressed. Further, when the expansion force receiving portions 46a and 46b are polygons (for example, a triangle, a quadrangle, etc.), it is preferable that the corners are chamfered. By adopting such a configuration, it is possible to prevent the medical container body 2 from being damaged.

  The discharge port encapsulating member 4 in the medical container 1 of the present embodiment is automatically detached from the medical container body 2 or released by pressing the medical container body 2 to release the partitioning portion 9. It is possible. Specifically, in the discharge port encapsulating member 4 of this embodiment, when the medical container 2 is pressed, the medical container body 2 expands and the expansion force is transmitted to the expansion force receiving portions 46a and 46b facing each other. As a result, the discharge port encapsulating member 4 expands, and the engagement between the first main body portion side engaging portions 45a and 45b and the second main body portion side engaging portions 44a and 44b is released, and the medical container main body 2 It becomes possible to leave more. As the discharge port encapsulating member, when the above-described medical container body 2 is expanded, the mounted state (engaged state) is released, and the medical container body moves downward according to the expanded state of the medical container body. The container body 2 may be automatically detached. The width and area of the expansion force receiving portions 46a and 46b described above are appropriately set in consideration of the size of the container body, the amount of medicine to be filled, and the like.

Further, the discharge port encapsulation member may be the discharge port encapsulation member 14 shown in FIGS. 17 to 22.
FIG. 17 is a front view of another embodiment of the discharge port encapsulating member used in the medical container of the present invention. 18 is a left side view of the discharge port encapsulation member of FIG. 19 is a plan view of the discharge port encapsulation member of FIG. 20 is a bottom view of the discharge port encapsulation member of FIG. FIG. 21 is a front view of a state in which the discharge port encapsulating member of FIG. 17 is developed. FIG. 22 is a rear view of the state in which the discharge port encapsulating member of FIG. 17 is developed.
The discharge port encapsulating member 14 of this embodiment is capable of bending the first main body 4a, the second main body 4b, the first main body 4a, and the second main body 4b that face each other when the medical container main body 2 is mounted. And a ring-shaped connecting portion 48 to be connected. The ring-shaped connecting portion 48 can bend the first hinge portions 43a and 43b that connect the first main body portion 4a and the ring-shaped connecting portion 48 in a foldable manner, and the second main body portion 4b and the ring-shaped connecting portion 48. Second hinge portions 47a and 47b to be connected are provided.
The difference between the discharge port encapsulating member 14 of this embodiment and the discharge port encapsulating member 4 of the above-described embodiment is only the connection form between the first main body portion 4a and the second main body portion 4b. Is the same as the discharge port encapsulating member 4 described above.

Next, the manufacturing method of the medical container 1 of this invention is demonstrated. The method is not limited to this method.
First, a tube body formed of a soft synthetic resin is prepared. And the upper end side seal part 21 which has one partial unsealed part (mixed injection port attachment part 23) in this tube body, the lower end side seal part 22 which has one partial unsealed part (discharge port attachment part 24), The partition part 9 is formed to form the soft bag 2a. Subsequently, the cylindrical portion 31 of the discharge port 3 is inserted and fixed to the discharge port mounting portion 24 which is a partially unsealed portion of the lower end side seal portion 22. After injecting the first drug 7 into the first drug chamber 5 via the cylindrical part 31, the sealing part 36 is attached to the cylindrical part 31 in a state where the container is fixed so that the cylindrical part 31 faces upward. Is fixed and sealed.
Then, the cylindrical member of the mixed injection port 11 is fixed to the partially unsealed portion of the upper end side seal portion 21, and the second medicine 8 is injected through the cylindrical member so that the cylindrical member is on the upper side. In a state where the container is fixed, a cap member having an elastic member attached to the cylindrical member is fixed and sealed. Thereby, the soft medical container main body 2 is formed. And the medical container 1 is manufactured by attaching the discharge port covering member 4 to the discharge port part of this soft medical medical container main body 2. FIG.
In this manner, a medical container filled with a medicine as shown in FIG. 1 is produced. The injection of the first drug 7 and the sealing operation of the first drug chamber 5 may be performed before the injection of the second drug 8 and the sealing operation of the second drug chamber 6.

Next, the usage method of the medical container 1 of this invention is demonstrated.
First, when the second drug chamber 6 of the medical container 1 is strongly pressed with a finger or the like, the partition 9 is first broken, and then the first drug chamber 5 is caused by the inflow of the drug solution from the second drug chamber 6. As shown in FIG. 12, two first main body portion side engaging portions 45a and 45b of the first main body portion 4a and two second main body portion side engaging portions 44a and 44b of the second main body portion 4b. Is released, and the discharge port encapsulating member 4 opens and can be detached from the container body 2. Then, after the discharge port encapsulating member 4 is removed from the container body 2, the operation portion 38 of the discharge port 3 is gripped and the breakable portion 34 is broken, as shown in FIG. Surfaced in the drug. Further, the medicine discharge member connection inhibiting portion 37 also flows out from the discharge port and floats in the medicine. Accordingly, the medicine discharge member can be connected, and the preparation for drug administration is completed by inserting the drug discharge member into the discharge port 35 of the discharge port 3.

Next, a medical container 20 according to another embodiment of the present invention will be described.
FIG. 23 is a front view of another embodiment of the medical container of the present invention. FIG. 24 is an explanatory view for explaining another embodiment of the discharge port encapsulating member used in the medical container of the present invention. FIG. 25 is an explanatory view for explaining another embodiment of the discharge port encapsulating member used in the medical container of the present invention.
The medical container 20 of this embodiment is divided into a first drug chamber 5 and a second drug chamber 6 by a partition portion 9 formed by a peelable seal portion, and the first drug chamber 5 is filled. A discharge having a discharge port 35 that communicates with any one of the drug chambers and can be connected to a drug discharge member, and the first drug 7 that is filled, the second drug 8 that is filled in the second drug chamber 6 A soft medical container body 2 having a port 3 and a discharge port encapsulating member 4 detachably attached to the medical container body 2 are provided.

  The discharge port 3 is provided in the cylindrical portion 31 having a drug storage portion 32 inside and closed at one end side and opened at the other end side, and communicates with the drug chamber of the drug storage portion 32 by breaking. Provided in the cylindrical portion 31 is a breakable portion 34 that can be opened, a discharge port 35 that closes the other end of the cylindrical portion 31 and has a sealing portion 36 that can be connected to a medicine discharge member. The medicine discharge member connection inhibition portion 37 that inhibits the connection of the medicine discharge member to the discharge port 3 when the breakable portion 34 is not broken is allowed to flow out, and the third portion stored in the medicine storage portion 32. The medicine 33 is provided. Further, the discharge port encapsulating member 4 regulates the breakage of the breakable portion 34 of the discharge port 3 and breaks by pressing the medical container body 2 in order to release the partition portion 9 of the medical container body 2. The restriction of breakage of the possible portion 34 is released.

The medical container body 2 includes a detachable communication blocking weak seal portion 12 that blocks communication between the drug chamber and the discharge port 3.
The substantial difference between the medical container 20 of this embodiment and the medical container 1 described above is only the presence of the weak seal portion 12 for inhibiting communication.
As shown in FIG. 23, the medical container body 2 of the medical container 20 includes a weak seal portion 12 for preventing communication.
The weak seal portion 12 for inhibiting communication is formed so as to surround the upper portion of the discharge port 3. A third chamber 26 isolated from the first medicine chamber 5 is formed by the weak seal portion 12 for inhibiting communication.
The weak seal portion 12 for inhibiting communication can be formed by heat-sealing the sheet material in a band shape (thermal fusion, high frequency fusion, ultrasonic fusion, etc.). In the embodiment shown in FIG. 23, the communication inhibiting weak seal portion 12 is formed in a trapezoidal shape with the short side on the upper side. In addition, the weak seal portion for preventing communication has an inverted U-shape, a triangular shape with the discharge port at the top, a triangular shape with the discharge port at the bottom, a polygonal shape such as a quadrangle, a substantially semicircular shape, and a substantially semielliptical shape. Etc. Further, the weak seal portion 12 for inhibiting communication is peeled off by pressing either the first drug chamber 5 or the second drug chamber 6.

It is preferable that the seal strength (initial peel strength) of the weak seal portion 12 for inhibiting communication is greater than the seal strength of the partition portion 9. Specifically, the seal strength of the partition portion 9 is preferably 0.1 to 25 N / 10 mm, and more preferably 0.3 to 20 N / 10 mm. Further, the sealing strength (initial peel strength) of the weak seal portion 12 for inhibiting communication is preferably 1 to 25 N / 10 mm, particularly preferably 2 to 20 N / 10 mm.
Moreover, it is preferable that the weak seal part 12 for communication inhibition is provided below the partition part 9, as shown in FIG. By being provided below the partition part 9, the weak seal part 12 for inhibiting communication is easily and reliably peeled off during the partition part peeling operation.
The third chamber 26 formed by the weak seal portion 12 for inhibiting communication is an empty chamber. However, the third chamber 26 may be filled with a predetermined liquid (for example, physiological saline). The third chamber 26 may be in a dry state, but may contain a small amount of liquid for sterilization. Furthermore, a passage through which some water vapor or medicine passes through the weak seal portion 12 for inhibiting communication may be formed so as to communicate with the first medicine chamber 5 at the above level.

In the medical container 20 of this embodiment, the expansion force receiving portion 46 of the discharge port encapsulating member 4 is formed so as not to be applied to the communication inhibiting weak seal portion 12. For this reason, the pressure is applied to the expansion force receiving portion 46 only after the weak seal portion 12 for inhibiting communication due to the pressing of the medicine chamber is peeled, and the restriction on the breakage of the breakable portion 34 is released. In the medical container 20 of this embodiment, the pressure necessary for releasing the breakage restricting portion state of the discharge port encapsulating member 4 is smaller than the pressure necessary for peeling the weak seal portion 12 for inhibiting communication. preferable.
Further, as the discharge port encapsulating member, an expansion force receiving portion may be present on the weak seal portion 12 for inhibiting communication. For example, as in the medical container 20a (FIG. 24) using the discharge port encapsulating member 54 of the type shown in FIG. 14, the expansion force receiving portion 46 of the exhaust port encapsulating member 54 is weak for communication inhibition. A type formed to encapsulate the distal end portion of the seal portion 12, a type such as a medical container (not shown) using the discharge port encapsulating member 64 shown in FIG. 15, FIG. Like the medical container 20b (FIG. 25) using the discharge port encapsulating member 74 of the type as shown in FIG. 25, the expansion force receiving portion 46 of the exhaust port encapsulating member 74 is connected to the weak seal portion 12 for inhibiting communication. It may be formed so as to encapsulate almost the whole. In these types of medical containers, a part of the expansion force receiving portion of the discharge port encapsulating member exists on the weak seal portion 12 for inhibiting communication. For this reason, a part of the expansion force receiving portion of the discharge port covering member protects the weak seal portion for communication inhibition. In these types of medical containers, when the drug chamber is pressed to peel off the partition portion, the weak seal portion 12 for inhibiting communication is peeled off at the same time as or slightly behind the protection release by the discharge port encapsulating member.

FIG. 1 is a front view of an embodiment of the medical container of the present invention. FIG. 2 is a cross-sectional view of the medical container of FIG. 1 taken along line AA. FIG. 3 is a front view of an example of a discharge port encapsulating member used in the medical container shown in FIG. FIG. 4 is a left side view of the discharge port encapsulating member of FIG. FIG. 5 is a plan view of the discharge port encapsulation member of FIG. FIG. 6 is a bottom view of the discharge port encapsulating member of FIG. FIG. 7 is a front view of a state in which the discharge port encapsulating member of FIG. 3 is developed. 8 is a rear view of the state in which the discharge port encapsulating member of FIG. 3 is developed. FIG. 9 is a front view of an embodiment of the discharge port used in the medical container shown in FIG. 10 is a cross-sectional view of the discharge port of FIG. 11 is a cross-sectional view of the discharge port of FIG. 9 taken along the line BB. FIG. 12 is an explanatory diagram for explaining a method of using the medical container shown in FIG. FIG. 13 is an explanatory diagram for explaining a method of using the medical container shown in FIG. FIG. 14 is a front view of another embodiment of the discharge port encapsulating member used in the medical container of the present invention. FIG. 15 is a front view of another embodiment of the discharge port encapsulating member used in the medical container of the present invention. FIG. 16 is a front view of another embodiment of the discharge port encapsulating member used in the medical container of the present invention. FIG. 17 is a front view of another embodiment of the discharge port encapsulating member used in the medical container of the present invention. 18 is a left side view of the discharge port encapsulation member of FIG. 19 is a plan view of the discharge port encapsulation member of FIG. 20 is a bottom view of the discharge port encapsulation member of FIG. FIG. 21 is a front view of a state in which the discharge port encapsulating member of FIG. 17 is developed. FIG. 22 is a rear view of the state in which the discharge port encapsulating member of FIG. 17 is developed. FIG. 23 is a front view of another embodiment of the medical container of the present invention. FIG. 24 is an explanatory view for explaining another embodiment of the discharge port encapsulating member used in the medical container of the present invention. FIG. 25 is an explanatory view for explaining another embodiment of the discharge port encapsulating member used in the medical container of the present invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Medical container 2 Medical container main body 3 Discharge port 4 Discharge port encapsulation member 5 1st chemical | medical agent chamber 6 2nd chemical | medical agent chamber 7 1st chemical | medical agent 8 2nd chemical | medical agent 9 Partition part

Claims (6)

A first medicine that is divided into a first medicine chamber and a second medicine chamber by a partition formed by a peelable seal portion, and that is filled in the first medicine chamber, and the second medicine A soft medical container main body comprising: a second medicine stored in a chamber; and a discharge port that communicates with any one of the drug chambers and has a discharge port that can be connected to a drug discharge member; and the medical container A medical container comprising a discharge port encapsulating member detachably attached to a main body,
The discharge port is closed at one end side and opened at the other end side, and has a cylindrical portion having a drug storage portion therein, and is provided in the cylindrical portion, and can communicate with the drug chamber of the drug storage portion by breaking. The breakable portion, the other end side of the cylindrical portion, the discharge port having a sealing portion that can be connected to the medicine discharge member, and the breakage provided in the cylindrical portion A medicine discharge member connection inhibiting portion that inhibits connection of the medicine discharge member to the discharge port when the possible portion is not broken, and a third medicine stored in the drug storage portion; It is prepared
The discharge port encapsulating member regulates breakage of the breakable portion of the discharge port and can be broken by pressing the medical container body to release the partition portion of the medical container body A medical container characterized in that the restriction of breakage of the part is released. The medical container according to claim 1, wherein the discharge port includes an operation portion for performing a breaking operation of the breakable portion, and the discharge port encapsulating member regulates a breaking operation of the operation portion. . The medical container according to claim 1, wherein the discharge port encapsulating member includes a mounting portion for mounting on the medical container main body. The medical according to any one of claims 1 to 3, wherein the discharge port encapsulating member includes an opposing expansion force receiving portion for receiving an expansion force of the medical container body when the medical container is pressed. Container. The medical container according to any one of claims 1 to 4, wherein the discharge port encapsulating member exposes the sealing portion of the discharge port when mounted on the medical container main body. The medical container according to any one of claims 1 to 5, wherein the medical container main body includes a peelable communication-inhibiting weak seal portion that inhibits communication between the drug chamber and the discharge port.

Images