JP7373990B2 - Infusion containers and drug containers used therein - Google Patents

Description

TECHNICAL FIELD The present invention relates to an infusion container in which a drug can be mixed into a medicinal solution such as an infusion, and a drug container used therein.

Before administering an infusion to a patient, drugs that are difficult to incorporate into an infusion, such as vitamins and antibiotics, are mixed and dissolved in a vial or soft bag containing the infusion. is being prepared. In order to prepare such a drug solution aseptically and with simple operation, a drug container containing the drug to be mixed with the drug solution is attached to a soft bag containing the drug solution, and when infusion is carried out, a drug container containing the drug to be mixed with the drug solution is attached. An infusion container has been proposed in which a breakable part (fragile part) is bent over a soft bag and broken, thereby communicating the drug container and the soft bag and mixing the drug and the drug solution.

As such an infusion container, the applicant of the present application has proposed Japanese Patent Application Publication No. 2012-183180 (Patent Document 1).
This infusion container 1 of Patent Document 1 includes a drug container 3 attached to a soft bag 2. The medicine container includes a medicine container main body part 5 having a medicine storage part 54, a breakable part 56, and an operation part 55 for breaking operation, and a cylindrical part 6 that encloses the breakable part 56 at a distal end part 64. . The cylindrical portion 6 includes a diameter-reduced tip portion 64 that envelops the breakable portion 56 and the proximal end portion 55a of the operating portion, and a diameter-reduced tip portion 64 that encloses the diameter-reduced tip portion 64 and extends beyond the tip. 64, and prevents the broken end 55b of the breakable part 56 and the proximal end 55a of the operating part from coming into contact with the inner surface of the soft bag during the breaking operation of the operating part 55. It is provided with a cylindrical flexible covering part 63.

Japanese Patent Application Publication No. 2012-183180

The above-mentioned infusion container has sufficient effects. However, the drug container main body 5 used in the above-mentioned infusion container is a thin tubular body with a closed upper end and has a drug storage portion 54, a breakable portion 56, and an operating portion 55 for breaking operation. It has been found that in this type of drug container main body 5, pinholes occur in the breakable portion 54 portion. In manufacturing a thin tubular body with a closed upper end as described above, the core pin of the mold used to form the internal shape is thin and has a certain length, with the tip being a free end and only the proximal end. I feel supported. Upon investigation, the inventor found that the cause of pinholes in the breakable portion is the inclination of the core pin caused by the injected resin flow coming into contact with the core pin. Since the breakable part originally has a thin wall thickness, it was found that even a slight deviation in the thickness of the side wall could cause a pinhole.

In an infusion container comprising a soft bag containing a drug solution and a hard synthetic resin drug container attached to the soft bag and containing a drug to be mixed with the drug solution, the above-mentioned pinhole in the synthetic resin drug container is provided. If this occurs, the drug in the synthetic resin drug container may leak into the soft bag, or conversely, the drug solution in the soft bag may flow into the synthetic resin drug container, resulting in deterioration of the drug solution or drug. It becomes a factor.

The first object of the present application is to provide an infusion container made of synthetic resin, comprising a soft bag containing a drug solution and a hard synthetic resin drug container attached to the soft bag and containing a drug to be mixed with the drug solution. There are very few pinholes in the drug container, and there is no mixing between the drug solution in the soft bag and the drug in the synthetic resin drug container before the synthetic resin drug container is broken, and the drug solution in the soft bag and the synthetic resin drug container do not mix. An object of the present invention is to provide an infusion container capable of maintaining a drug in a good condition in the drug container, and a drug container used therein that has extremely few pinholes.

In addition, the present inventors investigated the above-mentioned infusion container and found that in the hard drug storage hollow body used in the above-mentioned infusion container, when the breakable part is broken, the breakage occurs due to the pressure of the operating part. As soon as the breakage of the flexible portion begins, the operating portion is tilted. It was necessary to further tilt the operating part until the breakable part was completely broken. For this reason, it is necessary to press the operating part for the breaking operation by a certain amount of stroke, which makes it difficult to completely separate the breakable part from the drug storage hollow body, making the breaking operation time-consuming or impossible to open completely. In some cases, the medicinal solution stored in the container could not be discharged sufficiently.

The second object of the present application is to provide an infusion container in which a medicine can be mixed into a medicinal solution such as an infusion by a breaking operation, in which the operation until the breaking of the breakable part is completed by pressing the breaking operation part is as follows: An object of the present invention is to provide a container for infusion that allows easy and reliable infusion.

What achieves the above object of the present application is as follows.
( 1 ) An infusion container comprising a soft bag containing a drug solution, and a hard drug container attached to the soft bag and containing a drug to be mixed with the drug solution, the drug container containing a drug. The medicine storage hollow body includes a storage hollow body and a medicine stored in the medicine storage hollow body, and the medicine storage hollow body has a hollow medicine storage part, a breakable part, and extends in a distal direction from the breakageable part. a rupture operation section for performing a rupture operation of the breakable section, the breakage operation section having a proximal end portion located inside the distal end portion of the drug storage section; The portion is located inside the distal end portion of the drug storage portion, connects the inner circumferential surface of the drug storage portion and the outer circumferential surface of the proximal end portion of the breaking operation portion, and is connected to the central axis of the drug storage portion. The drug storage hollow body is formed of a thin ring-shaped connecting portion extending in substantially perpendicular directions, and the opening on the distal end side of the drug storage portion is releasably closed by the thin ring-shaped connecting portion and the breaking operation portion. Further, the breaking operation part includes an annular recess located close to the thin-walled ring-shaped connecting part and on the distal end side of the thin-walled ring-shaped connecting part, and the drug container is arranged in the hollow body for storing medicine. includes a cylindrical enveloping member that coaxially encloses the drug accommodating portion of the drug accommodating hollow body, the cylindrical enveloping member being located in front of the annular tip surface of the distal end portion of the drug accommodating portion of the drug accommodating hollow body. An infusion container comprising an annular inner rib located outside the annular recess of the breaking operation part.

( 2 ) The cylindrical enveloping member encloses the proximal end portion of the breaking operation portion, and protects the broken end of the breakable portion and the proximal end portion of the breaking operation portion during the breaking operation of the breaking operation portion. The infusion container according to ( 1 ) above, comprising a cylindrical flexible enveloping portion that restricts contact of the soft bag with the inner surface of the soft bag.
( 3 ) The annular inner rib of the cylindrical enveloping member cannot pass through the annular tip surface of the drug storage section of the drug storage hollow body, and is further away from the annular recess of the breaking operation section. The infusion container according to ( 1 ) or ( 2 ) above, wherein the front portion protrudes forward from the annular inner rib.

( 4 ) When the breaking operation of the breaking operation part starts breaking of the thin ring-shaped connection part, the breaking part of the breaking operation part enters into the medicine storage part of the medicine storage hollow body, and then , the outer surface of the annular recess of the breaking operation portion contacts the annular inner rib of the cylindrical enveloping member, thereby preventing further intrusion, and the breaking operation is performed using the abutted portion as a fulcrum. The infusion container according to any one of ( 1 ) to ( 3 ) above, wherein the infusion container continues to be used.
( 5 ) The cylindrical envelope member includes a cylindrical portion and a small-diameter tip portion having a smaller diameter than the cylindrical portion, and the annular inner rib is provided on the inner surface of the tip of the small-diameter tip portion . ) to ( 4 ).

( 6 ) The drug storage hollow body has a distal end side formed by an inner surface of the distal end portion of the drug storage portion, an outer surface of the proximal end portion of the breaking operation portion, and an inner surface of the thin ring-shaped connecting portion. The infusion container according to any one of (1) to ( 5 ) above, comprising an inner annular recess extending toward the infusion.
( 7 ) The breaking operation portion has a proximal end portion located inside the distal end portion of the drug storage portion, and the bottom surface of the proximal end portion is a connecting portion with the thin ring-shaped connecting portion. The infusion container according to any one of (1) to ( 6 ) above, which is located lower.
( 8 ) The infusion container according to any one of (1) to ( 7 ) above, wherein the drug container includes a sealing member to which a medical needle can be connected.

What achieves the above object of the present application is as follows.
(9) A hard drug container,
The medicine container includes a medicine storage hollow body having a hollow medicine storage part, a sealing member that seals a rear end opening of the medicine storage hollow body, and a medicine stored in the medicine storage hollow body. , a cylindrical enveloping member coaxially enveloping the drug accommodating portion of the drug accommodating hollow body,
The medicine storage hollow body includes the medicine storage part, a breakable part, and a breaking operation part for performing a breaking operation of the breakable part that extends in a distal direction from the breakable part, and the breakage operation part has a proximal end portion located inside the distal end portion of the drug accommodating portion at the proximal end portion,
The breakable portion is located inside the distal end portion of the drug storage portion, connects the inner circumferential surface of the drug storage portion and the outer circumferential surface of the proximal end portion of the breakage operation portion, and The drug storage hollow body is formed by a thin ring-shaped connecting portion extending in a direction substantially perpendicular to the central axis, and the opening on the distal end side of the drug storage portion is unsealed by the thin ring-shaped connecting portion and the breaking operation portion. Further, the breaking operation part includes an annular recess located close to the thin ring-shaped connection part and on a distal end side of the thin ring-shaped connection part,
The cylindrical enveloping member includes an annular inner rib located in front of the annular tip surface of the distal end portion of the drug accommodating portion of the drug accommodating hollow body and outside the annular recess of the breaking operation portion. A hard drug container.

The infusion container of the present invention is an infusion container that includes a soft bag containing a drug solution and a hard drug container attached to the soft bag and containing a drug to be mixed with the drug solution. The drug container includes a drug storage hollow body and a drug stored in the drug storage hollow body, and the drug storage hollow body includes a hollow drug storage portion, a breakable portion, and a portion disposed in a distal direction from the breakable portion. a break operation section for performing a break operation of the breakable section extending from the breakable section, the break operation section has a proximal end portion located inside the distal end of the drug storage section, and the break operation section , a thin wall located inside the distal end of the drug storage section, connecting the inner circumferential surface of the drug storage section and the outer circumferential surface of the proximal end of the breaking operation section, and extending in a direction substantially perpendicular to the central axis of the drug storage section. The medicine storage hollow body is formed of a ring-shaped connecting part, and the distal opening of the medicine storing part is releasably closed by a thin ring-shaped connecting part and a breaking operation part, and further, the breaking operation part is The drug container includes a cylindrical enveloping member that coaxially encloses the drug accommodating portion of the drug accommodating hollow body, and includes an annular recess located close to the thin ring-shaped connection portion and on the distal end side of the thin ring-shaped connection portion. The cylindrical enveloping member includes an annular inner rib located in front of the annular tip surface of the distal end portion of the drug accommodating portion of the drug accommodating hollow body and outside the annular recess of the breaking operation portion.

In this infusion container, the breakable portion of the hollow body for drug storage connects the inner circumferential surface of the distal end of the hollow drug storage portion and the outer circumferential surface of the proximal end of the rupture operation portion, and It is formed by a thin ring-shaped connecting part that is substantially perpendicular to the central axis of the part. Therefore, when the operation part is pressed and the breaking operation is started, the breaking part of the breaking operation part enters into the medicine storage part of the hollow body at the same time as the thin ring-shaped connecting part starts breaking, and then the breakable part is broken. progresses. At the beginning of the breaking operation, the breaking operation part does not move in the pressing direction, but sinks, in other words, moves slightly downward, and then the breaking of the breakable part progresses. The breaking operation portion then comes into contact with the annular inner rib of the cylindrical envelope member, and the contact portion serves as a fulcrum to continue the breaking operation and break the thin ring-shaped connection portion. In this infusion container, the necessary movement distance of the breaking operation part in the pressing direction during the entire breaking operation is shortened, and the breaking operation becomes easy.
In addition, this infusion container has extremely low occurrence of pinholes in synthetic resin drug containers with breakable parts, and maintains good separation between the drug solution in the soft bag and the drug in the synthetic resin drug container until use. can do.

FIG. 1 is a front view of an infusion container according to an embodiment of the present invention. FIG. 2 is an enlarged front view of a drug container with a discharge port function used in the infusion container of the present invention. FIG. 3 is a cross-sectional view taken along line AA of the drug container of FIG. FIG. 4 is a front view of the drug storage hollow body of the present invention used in the drug container of FIG. 2. FIG. FIG. 5 is an enlarged cross-sectional view taken along the line BB of the hollow body for accommodating medicine in FIG. 4. FIG. 6 is an enlarged plan view of the medicine storage hollow body of FIG. 4. FIG. 7 is an enlarged bottom view of the medicine storage hollow body of FIG. 4. FIG. 8 is a longitudinal sectional view of the cylindrical enveloping member used in the drug container of FIG. 2. FIG. 9 is a front view of the needle tube invasion inhibiting member used in the drug container of FIG. 2. FIG. FIG. 10 is an enlarged plan view of the needle tube invasion inhibiting member of FIG. 9. FIG. 11 is an enlarged bottom view of the needle tube invasion inhibiting member of FIG. 9. FIG. 12 is an enlarged view of the vicinity of the lower part of the breaking operation section of the medicine container shown in FIG. 3. FIG. FIG. 13 is an enlarged view of the vicinity of the thin ring-shaped connection portion of the drug container of FIG. 3. FIG. FIG. 14 is a sectional view (at the start of breaking) for explaining how to use the infusion container of the present invention. FIG. 15 is a sectional view (at the time of completion of breakage) for explaining how to use the infusion container of the present invention. FIG. 16 is a cross-sectional view (separation and breaking operation section floating) for explaining how to use the infusion container of the present invention. FIG. 17 is a cross-sectional view (when movement of the needle tube invasion inhibiting member is completed) for explaining how to use the infusion container of the present invention. FIG. 18 is a longitudinal sectional view of a drug container with a discharge port function using a hollow body for storing drugs according to another embodiment of the present invention. FIG. 19 is a front view of an infusion container according to another embodiment of the present invention. FIG. 20 is an enlarged front view of a drug container used in the infusion container of FIG. 19. FIG. 21 is a sectional view taken along line CC of the drug container of FIG. 20. FIG. 22 is a longitudinal sectional view of a hollow body for accommodating medicine according to another embodiment of the present invention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS The infusion container and medicine storage hollow body of the present invention will be explained below using examples shown in the drawings.
An infusion container 1 according to the first invention of the present application includes a soft bag 2 containing a medicinal solution, and a hard drug container 3 attached to the soft bag 2 and containing a drug to be mixed with the medicinal solution. The hard medicine container 3 includes a medicine storage hollow body 5 and a medicine 9 housed in the medicine storage hollow body.

The medicine storage hollow body 5 used in the infusion container 1 according to the first invention of the present application and the medicine storage hollow body 5 of the invention of the present application are synthetic resin injection molded products, and include a hollow medicine storage part 51, It includes a breakable portion 56 and a breaking operation portion 55 extending from the breakable portion 56 in the distal direction and for performing a breaking operation of the breakable portion 56. The breakable portion 56 is located inside the distal end portion (in this embodiment, the cylindrical small diameter distal end portion) 53 of the drug storage portion 51, and connects the inner peripheral surface of the drug storage portion 53 and the outer peripheral surface of the breaking operation portion 55. The drug storage hollow body 5 is formed by a thin ring-shaped connecting portion that connects and extends in a direction substantially perpendicular to the central axis of the drug storage portion 51. 56 and a breaking operation part 55 to open and close the seal.

Further, the infusion container 1 according to the second invention of the present application includes a soft bag 2 containing a drug solution, and a hard drug container 3 attached to the soft bag 2 and containing a drug to be mixed with the drug solution. Be prepared. The hard medicine container 3 includes a medicine storage hollow body 5 and a medicine 9 housed in the medicine storage hollow body. The medicine storage hollow body 5 includes a hollow medicine storage part 51, a breakable part 56, and a breaking operation part 55 for performing a breaking operation of the breakable part 56, which extends from the breakable part 56 in the distal direction. The breaking operation section 55 has a proximal end section 59 located inside the distal end section 53 of the drug storage section 51 at the proximal end section 58 . The breakable portion 56 is located inside the distal end portion 53 of the drug storage portion 51, connects the inner circumferential surface of the drug storage portion 51 and the outer circumferential surface of the proximal end portion 59 of the breakage operation portion 55, and It is formed by a thin ring-shaped connecting portion 56 that extends in a direction substantially perpendicular to the central axis of. In the drug storage hollow body 5, the opening on the distal end side (in this embodiment, the distal opening) of the drug storage section 51 is closed such that it can be opened by a thin ring-shaped connecting section 56 and a breaking operation section 55. Further, the breaking operation section 55 includes an annular recess 72 located close to the thin ring-shaped connection section 56 and on the tip side of the thin ring-shaped connection section 56 . The drug container 3 includes a cylindrical enveloping member 6 that coaxially encloses the drug accommodating portion 51 of the drug accommodating hollow body 5. An annular inner rib 67 is provided in front of the annular distal end surface 53 a of the distal end portion 51 and outside the annular recess 72 of the breaking operation section 55 .

As shown in FIG. 1, the infusion container 1 of this embodiment includes a soft bag 2 containing a drug solution, and a hard drug container 3 attached to the soft bag 2 and containing a drug 9 to be mixed with the drug solution. Equipped with. The hard medicine container 3 includes a medicine storage hollow body 5 made of synthetic resin injection molding, a sealing member (in this embodiment, a discharge port) 8 that seals the rear end opening of the hollow body 5, and a hollow body 5. 5 and a cylindrical enveloping member 6 that partially encloses the drug accommodating hollow body 5. The hard drug container 3 is attached to the soft bag 2 via a cylindrical enveloping member 6.

The infusion container 1 of this embodiment includes a drug container 3 with a discharge port function.
The infusion container 1 of this embodiment is made of a flexible material, and includes a soft bag 2 having a medicine chamber 11 which is a medicine storage part inside, and a discharge port function attached to the medicine chamber 11 of the soft bag 2. This is a drug-containing infusion container that includes a drug container 3 and a drug solution filled in a drug chamber 11.

The infusion container 1 of this embodiment includes a soft bag 2 containing a medicinal solution, and a hard drug container 3 attached to the soft bag 2 and containing a drug to be mixed with the medicinal solution. The hard medicine container 3 includes a medicine storage hollow body 5, a sealing member (in this embodiment, a discharge port 8) that seals the rear end opening of the medicine storage hollow body 5, and a medicine storage hollow body 5. and a medicine 9 housed inside. The medicine storage hollow body 5 includes a hollow medicine storage part 51, a breakable part 56 formed on the distal end side of the medicine storage part 51, and a breakable part 56 that allows the medicine inside the medicine storage part 51 to be discharged by breaking. A breaking operation part 55 is provided on the distal end side of the part 56 and is used to perform a breaking operation of the breakable part 56. The drug storage section 51 is closed by a breakable section 56 and a breakage operation section 55. The breakable part 56 connects the inner circumferential surface of the distal end of the hollow drug storage part 51 and the outer circumferential surface of the proximal end (lower part) of the breaking operation part 55, and is connected to the central axis of the drug storage part 51. It is formed by a thin ring-shaped connecting portion 56 that is substantially orthogonal.

Further, as shown in FIG. 1, seal portions 21 and 22 are provided on one end side and the other end side of the soft bag 2. Further, the upper end side seal portion 21 is provided with a hanging opening 24 . Further, a cylindrical enveloping member 6 for fixing the drug container 3 with a discharge port function is provided in the center portion of the lower end side seal portion 22.
The soft bag 2 of the infusion container 1 is made of soft synthetic resin. The soft bag 2 is preferably formed into a cylindrical shape by an inflation molding method. Note that the soft bag 2 may be manufactured by various methods such as a blow molding method and a coextrusion inflation method.

It is preferable that the soft bag 2 has water vapor barrier properties. As for the degree of water vapor barrier property, the water vapor permeability is preferably 50 g/m ² 24 hrs 40°C 90% RH or less, more preferably 10 g/m ² 24 hrs 40°C 90% RH or less and more preferably 1 g/m ² , 24 hrs, 40° C., 90% RH or less. This water vapor permeability is measured by the method described in JIS K7129 (Method A). Since the soft bag 2 has water vapor barrier properties as described above, evaporation of water from the inside of the infusion container 1 can be prevented. As a result, it is possible to prevent the amount of the drug (specifically, the drug solution) to be filled from decreasing and concentrating. Further, it is also possible to prevent water vapor from entering the infusion container 1 from outside.

Examples of materials for forming the soft bag 2 include various types of polyolefins such as polyethylene (PE), polypropylene (PP), polybutadiene, ethylene-vinyl acetate copolymer (EVA), olefin elastomers, and styrene elastomers. Examples include thermoplastic elastomers or arbitrary combinations thereof (blend resins, polymer alloys, laminates, etc.). The resin material used preferably has heat resistance and water resistance that can withstand high pressure steam sterilization (autoclave sterilization).

In the present invention, the material for forming the flexible bag 2 preferably contains polyolefin. Particularly preferable materials for forming the soft bag 2 include polyethylene or polypropylene, and a styrene thermoplastic elastomer such as a styrene-butadiene copolymer or a styrene-ethylene-butylene-styrene block copolymer, or an ethylene-propylene copolymer. Examples include soft resins made by blending olefinic thermoplastic elastomers such as ethylene-butene copolymers, propylene-α-olefin copolymers, and the like. This material is preferable because it has high strength, high flexibility, high heat resistance (especially heat resistance during sterilization), high water resistance, and particularly excellent workability, allowing for reduction in manufacturing costs.

Furthermore, the soft bag 2 may have a single layer structure (single layer structure) made of the above-mentioned materials, or may have a structure made of multiple layers (especially layers of different materials) for various purposes. It may also 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. When a plurality of resin layers are stacked, it is possible to have the advantages of each resin, for example, the impact resistance of the soft bag 2 can be improved or blocking resistance can be imparted. In addition, in the case of having a metal layer, the gas barrier properties of the soft bag 2 can be improved. For example, when films such as aluminum foil are laminated, gas barrier properties can be improved and light blocking properties can be imparted. In addition, when a layer made of an oxide such as titanium oxide, aluminum oxide, silicon oxide, etc. is formed, the gas barrier properties are improved and the transparency of the soft bag 2 can be maintained, ensuring internal visibility. I can do it. In addition, when the soft bag 2 is a multilayer laminate, it is preferable that the material forming the inner surface portion thereof is the above-mentioned material.

The thickness of the sheet material constituting the soft bag 2 is appropriately determined depending on its layer structure and the characteristics of the material used (flexibility, strength, water vapor permeability, heat resistance, etc.), and is not particularly limited. However, it is usually preferably about 100 to 500 μm, more preferably about 200 to 360 μm.
Although the volume of the infusion container 1 varies depending on the type of medicine stored therein, it is usually preferable that the volume of the medicine chamber is about 50 to 5000 ml.

In addition, in the infusion container 1 of this embodiment, the internal space of the soft bag 2 is divided into a first drug chamber 11 and a second drug chamber 12 by a removable partition 25. The drug container 3 with a discharge port function is fixed to the first drug chamber 11 side, and the co-injection port 18 is fixed to the second drug chamber 12 side. A first medicine is stored in the first medicine chamber 11, and a second medicine is stored in the second medicine chamber 12. Further, the infusion container 1 of this embodiment includes a peelable weak communication-blocking seal portion 26 that blocks communication between the first drug chamber 11 and the discharge port (hard drug container 3).

The communication inhibiting weak seal portion 26 is formed so as to surround the upper part of the drug container 3 with a discharge port function. A third chamber 28 isolated from the first drug chamber 11 is formed by this communication-blocking weak seal portion 26 . This third room 28 is vacant. However, the third chamber 28 may contain a predetermined liquid (eg, physiological saline). Further, the third chamber 28 may be in a dry state, or may be filled with a small amount of liquid for sterilization. Furthermore, a passage may be formed in the communication-inhibiting weak seal portion 26 to allow some water vapor or a drug to pass therethrough, so as to communicate with the first drug chamber 11 at the level described above. The partition portion 25 and the weak communication-blocking seal portion 26 can be formed by releasably heat-sealing (thermal fusion, high-frequency fusion, ultrasonic fusion, etc.) a sheet material into a belt shape.

In the embodiment shown in FIG. 1, the communication-impeding weak seal portion 26 is formed in a trapezoid shape with the short side facing upward. In addition, the communication-obstructing weak seal portion may have a polygonal shape such as an inverted U-shape, a trapezoidal shape with the short side facing downward, a triangular shape with the discharge port as the apex, a triangular shape with the discharge port as the base, or a square shape. It may be approximately semicircular or approximately semielliptical. Further, it is preferable that the sealing strength of the communication-obstructing weak seal portion 26 is equal to, slightly larger than, or slightly smaller than the sealing strength of the partition portion (partitioning weak seal portion) 25. If this is the case, the drug solution will not be administered in a state where the partition portion 25 is not peeled off, and preparations for administration can be made with easy operations.

Further, it is preferable that the weak communication-blocking seal portion 26 be peeled off by pressing the first drug chamber 11 or the second drug chamber 12, substantially simultaneously with or subsequent to the peeling off of the partition portion 25.
As shown in FIG. 1, the infusion container 1 of this embodiment includes two opposing side protruding seal portions 27 extending from the center of the side of the soft bag 2 toward the center of the soft bag 2. The partition portion 25 is connected to the two side protruding seal portions 27 and is provided so as to traverse the entire lateral direction of the medicine chamber of the soft bag 2.

As shown in FIGS. 2 and 3, the hard drug container 3 includes a drug storage hollow body 5, a sealing member (in this embodiment, a discharge port) 8 that seals the rear end opening of the hollow body 5, and , comprising a medicine 9 housed in a hollow body 5 and a cylindrical enveloping member 6.

Further, as shown in FIG. 14, the hard drug container 3 has a cylindrical enveloping member 6 inserted between sheet materials constituting the soft bag 2, and is fused and fixed in a liquid-tight state. has been done. Moreover, the breaking operation part 55 of the hard drug container 3 protrudes into the inside of the soft bag (specifically, into the third chamber 28). The medicine storage hollow body 5 of the hard medicine container 3 is fixed to the cylindrical enveloping member 6. Specifically, the cylindrical envelope member 6 of the hard drug container 3 is attached to the soft bag 2 in a liquid-tight manner by ultrasonic welding, high frequency welding, heat welding, or the like. By attaching the hard drug container 3 to the soft bag through the cylindrical enveloping member 6 in this way, the influence of energy such as heat generated during fusion can be reduced to the drug 9 in the hard drug container 3. can be prevented from spreading.

The medicine storage hollow body 5 is a synthetic resin injection molded product, and as shown in FIGS. 2 to 7, 12 and 13, it includes a hollow medicine storage part 51 having a cylindrical tip 53, and a medicine storage part 51 having a cylindrical tip 53. It includes a breakable part 56 formed on the distal end side of the part 51, and a breaking operation part 55 extending from the breakable part 56 in the distal direction for performing a breaking operation of the breakable part. The drug storage portion 51 is closed by a breakable portion 56 and a break operation portion 55, and the break operation portion 55 has a base located inside the cylindrical tip portion 53 of the drug storage portion 51 at a proximal end portion 58. It has an end portion 59. The breakable portion 56 is located inside the distal end portion 53 of the drug storage portion 51 and connects the inner circumferential surface of the distal end portion 53 of the drug storage portion 51 and the outer circumferential surface of the proximal end portion 59 of the breakage operation portion 56, Moreover, it is formed by a thin ring-shaped connecting portion extending in a direction substantially perpendicular to the central axis of the drug storage portion 51 . In the medicine storage hollow body 5, the opening on the distal end side of the cylindrical distal end portion 53 is openably closed by a thin ring-shaped connecting portion 56 and a breaking operation portion 55.

In the medicine storage hollow body 5 of this embodiment, the cylindrical tip portion 53 is a cylindrical small diameter tip portion. Further, the external shape of the proximal end portion 59 of the proximal end portion 58 of the breaking operation portion 55 is smaller than the internal shape of the cylindrical tip portion 53. Therefore, the proximal end portion 59 of the proximal end portion 58 of the breaking operation portion 55 and its proximal end enter into the inside of the cylindrical tip portion 53 of the drug storage portion 51 . Further, the medicine storage hollow body 5 of this embodiment has a synthetic resin injection gate position 91 at the upper end of the breaking operation section 56 or above the base end surface of the breaking operation section 56.

The hard medicine container 3 of this embodiment includes a medicine storage hollow body 5 having a medicine storage part 51, a breakable part 56, and a breaking operation part 55, and an opening of the medicine storage hollow body 5 sealed. At the same time, there is an ejection port 8 to which a medical needle can be connected (punctured), a needle tube invasion inhibiting member 4 stored in the drug storage part 51 of the drug storage hollow body 5, and a medicine filled in the medicine storage part 51. It is equipped with a drug 9.

As shown in FIGS. 2 and 3, the discharge port 8 includes a sealing member 82 to which a medical needle can be connected (punctured), and this sealing member 82 is fixed to the opening of the drug storage hollow body 5. A cap member 81 is provided. The seal member 82 is compressed by the cap member 81 and the cylindrical base end portion 52 of the medicine storage hollow body 5 that has entered the cap member 81 . The cap member 81 has its fixing part (flange part 83) applied to the fixing part (flange part 57) provided at the proximal end of the drug storage hollow body 5 while maintaining the above-mentioned clamping state. It is fixed by fusion, high frequency fusion, heat fusion, etc.

The drug storage section 51 of the drug storage hollow body 5 is preferably formed to be transparent so that the drug inside can be visually observed. The medicine accommodating portion 51 of the medicine accommodating hollow body 5 may be under normal pressure, or may be under reduced pressure or a vacuum state. In this manner, when the drug storage section 51 is in a reduced pressure or vacuum state, the effect of preventing alteration, decomposition, deterioration, etc. of the drug is improved.

The drug 9 to be stored may be in any solid form such as powder or granules, or in liquid form. Medications include those that are mixed and dissolved in infusions, such as antibiotics, vitamins (multivitamins), various amino acids, antithrombotic agents such as heparin, insulin, antitumor agents, analgesics, cardiotonic agents, and tranquilizers. Examples include anesthetics, anti-Parkinson's agents, ulcer treatment agents, adrenal corticosteroids, arrhythmia agents, corrective electrolytes, antiviral drugs, immunostimulants, and the like.

As shown in FIGS. 3, 5, 12, and 13, the drug storage section 51 of the drug storage hollow body 5 has a distal opening closed by the proximal end of the breakage operation section 55 and the breakable section 56. There is. The drug storage section 51 includes a storage section main body section 54 and a cylindrical small-diameter tip section 53 that is smaller in diameter than the storage section main section 54, and a thin ring-shaped connecting section 56 is connected to the inner circumferential surface (annular-shaped The inner surface) and the outer circumferential surface (annular outer surface) of the proximal end portion 59 of the proximal end portion 58 of the breaking operation portion 55 are connected. Further, the drug storage section 51 includes a cylindrical tapered section 54a that connects the storage section main body section 54 and the cylindrical small-diameter tip section 53.

The drug storage portion 51 has approximately the same outer diameter except for the tip end, and a flange portion 57 that projects annularly is provided at the base end thereof. The volume of the drug storage section 51 is preferably 1 to 30 ml. Further, the length of the drug storage section 51 is preferably 20 to 70 mm.

As shown in FIG. 3, FIG. 5, FIG. 7, FIG. 12, and FIG. , and faces toward the tip of the medicine storage hollow body 5. Specifically, the breakable portion 56 is not for opening the medicine storage hollow body 5 at the cylindrical side part, but for opening the top part of the medicine storage hollow body 5 inside the periphery. ing.
Specifically, the breakable portion 56 connects the inner circumferential surface of the distal end portion of the hollow drug storage portion 51 and the outer circumferential surface of the proximal end portion 59 of the proximal end portion 58 of the breakage operation portion 55, and It is formed by a thin ring-shaped connecting portion 56 that is substantially perpendicular to the central axis of the drug storage portion 51 . The thin ring-shaped connecting portion 56 is a flat annular thin portion.

In this embodiment, as shown in FIGS. 12 and 13, the thin ring-shaped connecting portion 56 is arranged so as to be perpendicular to the center axis of the drug storage portion 51 inward from the inner peripheral surface of the tip of the drug storage portion 51. (In other words, it is a narrow plate-shaped ring portion that extends perpendicularly from the inner circumferential surface of the tip of the drug storage portion 51 toward the central axis of the drug storage portion 51). .

The thin ring-shaped connecting portion 56 extends from the inner circumferential surface of the distal end of the drug accommodating portion 51 toward the outer circumferential surface of the proximal end portion 59 of the proximal end portion 58 of the breaking operation portion 55 . The connecting portion of the thin ring-shaped connecting portion 56 with the inner circumferential surface of the distal end of the drug storage portion 51 gradually becomes thicker toward the outer circumferential surface of the proximal end portion 59 of the proximal end portion 58 of the breaking operation portion 55. It's getting thinner. The thin ring-shaped connecting portion 56 has substantially the same thickness, extends for a predetermined length, and is connected to the outer circumferential surface of the proximal end portion 59 of the proximal end portion 58 of the breaking operation portion 55 .

The width of the portion of the thin ring-shaped connecting portion 56 that extends with the same thickness is preferably 0.05 to 1.50 mm, particularly preferably 0.20 to 0.50 mm. Further, the thickness of the portion of the thin ring-shaped connecting portion 56 that extends with the same thickness is preferably 0.05 to 1.00 mm, particularly preferably 0.10 to 0.50 mm. The thin ring-shaped connecting portion 56 is the thinnest portion at the tip of the medicine storage hollow body 5, and can be broken by pressing the operating portion 55. The length (thickness) of the breaking operation section 55 at the portion that enters into the drug storage section 51 is preferably 0.05 to 1.00 mm, particularly preferably 0.25 to 0.75 mm.

In this embodiment, as shown in FIGS. 12 and 13, the breaking operation section 55 has a proximal end portion 61 located inside the distal end of the drug storage section 51 at the proximal end. The bottom surface is located below the connection part with the thin ring-shaped connection part 56. For this reason, the proximal end portion 61 includes a bottom portion 73 that extends downward from the connecting portion with the thin ring-shaped connecting portion 56 and enters into the drug storage portion 51 . Therefore, the connecting portion (connection portion) of the thin ring-shaped connecting portion 56 with the breaking operation portion 55 is located slightly above the lower end (lower surface 73) of the breaking operation portion 55. In this embodiment, the bottom surface of the bottom portion 73 is a flat surface. Note that the bottom of the breaking operation section 55 has a base end 58a having a bottom surface 73a that bulges toward the inner bottom surface of the drug storage section 51, like the medicine storage hollow body 5c of the embodiment shown in FIG. It may be something. The bulging bottom surface 73a preferably has a hemispherical or bullet-shaped cross section.

In this embodiment, the medicine storage hollow body 5 has a thin ring-shaped connection between the inner surface of the distal end portion of the hollow medicine storage portion 51 and the outer surface of the proximal end portion 59 of the proximal end portion 58 of the breaking operation portion 55. It has an inner annular recess formed by a breakable portion 56 and extending toward the distal end side. Note that the annular recess may be provided on the outside (top side), and in this case, the thin ring-shaped connecting portion (breakable portion) 56 is located at a portion slightly closer to the proximal end than the distal end of the drug storage portion 51. It becomes the thing that is located.

In the medicine storage hollow body 5 of this embodiment, as shown in FIGS. 12 and 13, the breaking operation part 55 is located close to the thin ring-shaped connection part 56 and on the distal end side. The annular recess 72 has an outer diameter smaller than the inner diameter of the portion 56 (the inner diameter at the connection portion with the breaking operation portion 55). The breaking operation portion 55 includes a bulge portion 71 having a larger outer diameter than the annular recess 72 in front of the annular recess 72 . The annular recess 72 includes an annular inclined surface 74 whose diameter increases toward the bulge 71 .

When the breaking operation part 55 of the thin ring-shaped connecting part 56 is bent, as shown in FIG. It will fall down. Further, by continuing the pressing, the thin ring-shaped connecting portion 56 is entirely broken.

The breaking operation section 55 includes a plate-like main body part 78 and a plurality of reinforcing parts 79 formed on both sides of the plate-like main body part along the axial direction and perpendicular to the plate-like main body part. The reinforcing portion 79 becomes a gripping portion that is gripped during a breaking operation, and the thickness becomes thinner from the base end to the tip end. Further, by having the reinforcing portion, the breaking operation portion 55 becomes difficult to deform in the bending direction, and the force applied during the breaking operation is reliably concentrated on the breakable portion 56.

The medicine storage hollow body 5 of this embodiment has a synthetic resin injection gate position 91 at the upper end of the breaking operation section 56 or above the base end surface of the breaking operation section 56, as shown in FIGS. 4 to 6. . In this embodiment, the upper end of the breaking operation part 56 has a central recess, and this central recess is the gate position 91. The gate position 91 is located on the central axis of the medicine storage hollow body 5. Further, the resin flow flowing in from the gate position 91 comes into contact with the distal end surface of the core pin that forms the proximal end surface of the breaking operation section 56 . Even if the core pin is slightly tilted due to the resin flow, the thickness of the portion where the thin ring-shaped connection portion (breakable portion) 56 is formed does not change. Therefore, the thin ring-shaped connecting portion (breakable portion) 56 has a designed wall thickness, and pinholes are not formed in this portion.

As shown in FIG. 8, the cylindrical envelope member 6 has a cylindrical shape with open distal and proximal ends, and includes a cylindrical main body portion 61, a proximal end portion of the breaking operation portion 55 of the medicine storage hollow body 5, Most parts of the drug storage part 51 including the tip thereof having the breakable part 56 are covered. Specifically, as shown in FIG. 8, the cylindrical enveloping member 6 includes a cylindrical main body portion 61 that encloses the drug accommodating portion 51 of the drug accommodating hollow body 5, and a rupture of the drug accommodating hollow body 5. a small-diameter tip portion 66 that encloses the proximal end portion of the operating portion 55 and the tip portion of the drug storage portion 51 having the breakable portion 56; a diameter-reducing tapered portion 64 that connects the cylindrical main body portion 61 and the small-diameter tip portion 66; A flange portion 62 provided at the base end portion of the cylindrical main body portion 61 is provided.

The cylindrical envelope member 6 includes an annular inner rib 67 located in front of the annular tip surface 53a of the drug storage section 51 of the drug storage hollow body 5 and outside the annular recess 72 of the breaking operation section 55. Specifically, an annular inner rib 67 is provided on the inner surface of the small diameter tip 66 of the cylindrical envelope member 6 . In particular, in this embodiment, the annular inner rib 67 is provided on the inner surface of the tip of the small-diameter tip portion 66 and extends inward so as to be orthogonal to the central axis of the cylindrical envelope member 6. . The annular inner rib 67 is not in contact with the breaking operation part 55 of the medicine storage hollow body 5.

As shown in FIGS. 12 and 13, the inner diameter of the annular inner rib 67 is larger than the outer diameter of the thin ring-shaped connecting portion 56 (the inner diameter of the tip of the hollow body 5 for storing medicine). The inner edge of the inner surface rib 67 is located in front of the annular tip surface 53a of the medicine storage section 51 of the medicine storage hollow body 5. Therefore, the annular inner surface rib 67 of the cylindrical envelope member 6 prevents the annular tip surface 53a of the drug accommodating portion 51 of the drug accommodating hollow body 5 from passing through. Further, the portion in front of the annular recess 72 of the breaking operation portion 55 projects further forward than the annular inner rib 67 . The annular inner rib 67 allows the bulge 71 of the breaking operation section 55 to pass through.

Further, as shown in FIGS. 2, 3, 8, 12, and 13, the cylindrical enveloping member 6 encloses the small diameter tip 66, extends beyond the tip of the small diameter tip 66, and extends toward the tip side. It extends to cover the proximal end portion of the breaking operation part 55 exposed from the small diameter tip part 66, and to the inner surface of the soft bag 2 at the breaking part of the breakable part 56 in the breaking operation part 55 and the breaking part of the breaking operation part 55. It is provided with a cylindrical flexible covering part 63 that restricts contact between the two parts.

The cylindrical flexible envelope part 63 of this embodiment has a proximal end on the inclined surface of the diameter-reducing tapered part 64, and extends in the distal direction with substantially the same inner diameter. Further, the cylindrical flexible enveloping portion 63 becomes thinner toward the tip. The cylindrical flexible enveloping part 63 has higher flexibility (in other words, is softer) at the tip side, so it is easily deformed after contact with the breaking operation part 55, and the base Since the end side is less flexible than the distal end side, in other words, it is harder than the distal end side, it is strongly pressed by the broken end (base end) of the breaking operation part 55. will not break. Further, the cylindrical flexible enveloping portion 63 is provided with two opposing notches 69 on the sides thereof. The cylindrical flexible envelope part 63 is preferably cylindrical, but may also be elliptical or polygonal. Further, the cylindrical enveloping member 6 is fixed to the soft bag 2 at the cylindrical main body portion 61, and the cylindrical flexible enveloping portion 63 is not fixed to the soft bag 2.

In the hard drug container 3 of the present invention, as shown in FIG. ) enters the drug storage portion 51 of the drug storage hollow body 5 , and then the outer surface (annular inclined surface 74 ) of the annular recess 72 of the breaking operation portion 55 meets the annular inner rib of the cylindrical enveloping member 6 . By abutting against 67, further intrusion is prevented, and the breaking operation continues using the abutted area as a fulcrum.

Specifically, as shown in FIG. 14, in the hard drug container 3 of the present invention, by pressing the breaking operation part 55, the thin ring-shaped connecting part 56 of the portion facing the pressing part is broken, and the breaking operation is performed. The broken portion (base end portion 59) of the portion 55 enters into the drug storage portion 51 of the drug storage hollow body 5, and the breakage operation portion 55 sinks diagonally downward slightly. Then, the annular inclined surface 74 of the annular recess 72 of the breaking operation part 55 comes into contact with the annular inner surface rib 67 of the cylindrical envelope member 6, thereby preventing further intrusion (sinking). Then, the contact area between the annular inclined surface 74 of the breaking operation part 55 and the annular inner rib 67 of the cylindrical envelope member 6 becomes a fulcrum, and the breaking operation is continued, and the unbroken part of the thin ring-shaped connecting part 56 is Upon rupture, the rupture operation part 55 is separated from the medicine storage hollow body 5, the medicine storage part 51 is opened, and the medicine inside the hard medicine container 3 can flow out.

Further, the drug storage hollow body 5 and the cylindrical enveloping member 6 are arranged so that the distal end side surface of the flange portion 57 of the drug storage hollow body 5 and the proximal end side surface of the flange portion 62 of the cylindrical envelopment member 6 are heated by ultrasonic melting. They are liquid-tightly joined by bonding, heat fusion, high frequency fusion, etc.

In addition, in the drug container 3 with a discharge port function of this embodiment, as shown in FIGS. 2 and 3, a needle tube invasion inhibiting member 4 for inhibiting the invasion of a medical needle tube is provided inside the drug storage hollow body 5. It is stored. The needle tube invasion inhibiting member 4 inhibits the medical needle tube from entering into the medicine storage hollow body 5 when the breakable portion 56 is not broken. The needle tube invasion inhibiting member 4 in this embodiment, as shown in FIGS. 9 to 11, has a main body portion 41 having a tip portion 45 that can come into contact with the bottom portion 73 of the breaking operation portion 55 of the medicine storage hollow body 5; It has a proximal end portion 43 against which the distal end of a medical needle tube can abut.

When a medical needle is inserted into the sealing member 82 while the breakable portion 56 of the hard drug container 3 (medicine storage hollow body 5) is in an unbroken state (the state shown in FIGS. 1 to 3), the needle The distal end abuts against the proximal end 43 of the needle tube invasion inhibiting member 4 and is prevented from entering. The operator can recognize that the breakable portion 56 of the medicine storage hollow body 5 is unbroken since the medical needle tube is in a state where it cannot be punctured. When the breakable portion 56 of the drug storage hollow body 5 is in an unbroken state, the length at which the medical needle tube can puncture the drug storage hollow body 5 is such that the opening of the medical needle tube does not communicate with the inside of the drug storage portion. Preferably, the length is the same. In addition, it is preferable that the needle tube invasion inhibiting member 4 does not inhibit the sinking of the breakable portion 56 during the breaking operation. Therefore, the space between the needle tube invasion inhibiting member 4 and the inside of the medicine storage hollow body 5 has at least a clearance for entry when the breakable portion 56 performs the breaking operation.

In the needle tube invasion inhibiting member 4 of this example, the main body portion 41 includes four axially extending plate portions 41a, 41b, 41c, and 41d, and a bottom surface 73 of the breaking operation portion 55, as shown in FIGS. 9 to 11. It has a tip portion (flat tip surface) 45 that can come into contact with the tip. The proximal end surface of the proximal end portion 43 is a flat surface having a protrusion 44 . The base end portion 43 includes four plate-like extensions 42a, 42b, 42c, and 42d that extend toward the outer edge of the four axially extending plate-like portions 41a, 41b, 41c, and 41d.

The needle tube invasion inhibiting member 4 is capable of rising (floating) within the medicine storage hollow body 5 after the breakable portion 56 of the medicine storage hollow body 5 is broken. Specifically, the needle canal invasion inhibiting member 4 is formed of a material having a lower specific gravity than the drug solution in the soft bag and the drug in the drug container. Further, as shown in FIG. 3, the needle canal invasion inhibiting member 4 has a distance between the opposing plate-shaped extension portions 42a and 42c, and a distance between 42b and 42d of the needle canal invasion inhibiting member, which is similar to the cylindrical shape of the drug storage hollow body 5. It is larger than the inner diameter of the small-diameter tip portion 53, and after the breakable portion 56 of the medicine storage hollow body 5 is broken, it rises inside the medicine storage hollow body 5 but does not flow out.
The needle tube invasion inhibiting member 4 may be capable of flowing out from the drug storage hollow body 5 after the breakable portion 56 of the drug storage hollow body 5 is broken.

The constituent materials of the drug storage hollow body 5, the cylindrical enveloping member 6, and the needle tube invasion inhibiting member 4 include hard polyvinyl chloride, polyethylene, polypropylene, polybutadiene, and cyclic polyolefin (specifically, ZEONEX (Nippon Zeon Co., Ltd.)). (manufactured by Mitsui Chemicals, Inc.), polyolefins such as polypropylene homopolymer, high-density polyethylene, polystyrene, poly(4-methylpentene-1), polycarbonate, ABS resin, acrylic resin, polymethyl methacrylate (PMMA) ), polyacetals, polyarylates, polyacrylonitrile, polyvinylidene fluoride, ionomers, acrylonitrile-butadiene-styrene copolymers, polyesters such as polyethylene terephthalate (PET), polybutylene terephthalate (PBT), butadiene-styrene copolymers, aromatics Examples include various resins such as group or aliphatic polyamides, or arbitrary combinations of these. Among these, hard polyvinyl chloride and polyethylene are highly safe and have excellent adhesion to the soft bag 2. , polypropylene, and polyester are preferred.

Further, as the drug container with a discharge port function used in the infusion container of the present invention, a drug container with a discharge port function 3a of the type shown in FIG. 18 may be used. This drug container 3a does not have the cylindrical enveloping member 6 provided in the hard drug container 3 described above.

The hard drug container 3a in this embodiment has a hollow drug storage section 51 in which the drug 9 is stored, and is formed on the distal end side of the drug storage section 51, so that the drug inside the drug storage section 51 can be discharged when broken. The drug storage hollow body 5a includes a breakable portion 56 and a breakage operation portion 55a provided on the distal side of the breakageable portion 56 for performing a breakage operation of the breakageable portion 56. The inside of the distal end portion of the drug accommodating portion 51 includes a distal end small inner diameter portion 75 and an inner diameter reduced diameter portion 76 whose inner diameter decreases in the direction 75 of the distal inner diameter small diameter portion.

Also in the medicine storage hollow body 5a of this embodiment, as shown in FIG. A thin ring-shaped connecting portion 56 that connects the inner circumferential surface of the distal end (inner circumferential surface of the distal end of It is formed. The thin ring-shaped connecting portion 56 is the same as described above.

Further, as shown in FIG. 18, the medicine storage hollow body 5a encloses the small inner diameter portion 75, extends beyond the tip of the small inner diameter portion 75, and is exposed from the small inner diameter portion 75. A cylindrical flexible tube envelops the proximal end portion of the breaking operation part 55a and restricts the contact of the breakable part of the breakable part 56 in the breaking operation part 55a and the base end of the breaking operation part 55a with the inner surface of the soft bag 2. A flexible enveloping portion 77 is provided.
Further, the discharge port 8 and the needle tube invasion inhibiting member 4 are also the same as those described above. In the hard medicine container 3a of this embodiment, the medicine storage hollow body 5a is directly fixed to the soft bag 2.

Next, how to use the infusion container 1 will be explained with reference to the attached drawings.
FIG. 12 is an enlarged view of the vicinity of the lower part of the breaking operation section of the hard drug container shown in FIG. 3. FIG. FIG. 14 is a sectional view (at the start of breaking) for explaining how to use the infusion container of the present invention. FIG. 15 is a sectional view (at the time of completion of breakage) for explaining how to use the infusion container of the present invention. FIG. 16 is a cross-sectional view (separation and breaking operation section floating) for explaining how to use the infusion container of the present invention. FIG. 17 is a cross-sectional view (when movement of the needle tube invasion inhibiting member is completed) for explaining how to use the infusion container of the present invention.

The cylindrical enveloping member 6 of the hard drug container 3 of the infusion container 1 is fixed with one hand, and the breaking operation part 55 is pressed through the soft bag 2 with the other hand. When the breaking operation part 55 is pressed, the thin ring-shaped connection part 56 in the part facing the pressing part breaks, and the broken part (base end part 59) of the breaking operation part 55 is exposed to the drug. It enters into the drug storage section 51 of the storage hollow body 5, and the breaking operation section 55 sinks diagonally downward slightly.

Further, if the pressing is continued, as shown in FIG. is prevented. Further, when the pressing is continued, the abutment area between the annular inclined surface 74 of the breaking operation part 55 and the annular inner rib 67 of the cylindrical enveloping member 6 becomes a fulcrum, and the breaking operation is continued, as shown in FIG. , the unbroken portion of the thin ring-shaped connecting portion 56 is broken, and as shown in FIG. 16, the breaking operation portion 55 is separated from the drug storage hollow body 5, and the drug storage portion 51 is opened. Then, as shown in FIG. 17, the separated breaking operation section 55 ascends within the soft bag 2. Subsequently, as shown in FIG. 17, the needle tube invasion inhibiting member 4 moves up the drug storage hollow body 5, and the drug 9 in the drug storage hollow body 5 flows into the soft bag 2.

An embodiment of the infusion container of the present invention separately provided with a discharge port and a hard drug container 3b will be described.
FIG. 19 is a front view of an infusion container according to another embodiment of the present invention. FIG. 20 is an enlarged front view of a hard drug container used in the infusion container of FIG. 19. FIG. 21 is a sectional view taken along line CC of the hard drug container of FIG. 20.
The infusion container 1a of this embodiment includes a soft bag 2a containing a drug solution, a hard drug container 3b attached to the soft bag 2a and containing a drug 9 to be mixed with the drug solution, and a discharge port 13. Be prepared.

The discharge port 13 is a part for discharging the chemical solution. The discharge port 13 includes a cylindrical member with openings at the distal end (lower side shown in FIG. 19) and base end (upper side shown in FIG. 19), and a sealed distal opening (mixed solution outlet) on the distal end side of the cylindrical member. It consists of an elastic member arranged so as to be fixed, and a cap (elastic member support member) that fixes the elastic member. The elastic member can be pierced with a needle tube, and the mixed solution in the drug chamber 11 can be infused by piercing the needle tube when necessary.

As shown in FIGS. 20 and 21, the hard drug container 3b consists of a hollow body 5b for storing a drug and a cylindrical enveloping member 6b. Note that the hard drug container 3b of this embodiment does not include the needle tube invasion inhibiting member 4. The hard drug container 3b is attached to the soft bag 2a by a cylindrical enveloping member 6b. Specifically, the cylindrical enveloping member 6b of the hard drug container 3b is made liquid-tight by the fixing part 29 formed on the drug container fixing part of the soft bag 2a by ultrasonic welding, high frequency welding, thermal welding, etc. is attached to.

The medicine storage hollow body 5b includes a hollow medicine storage part 51, a breakable part 56 formed on the distal end side of the medicine storage part 51, and a breakable part 56 that allows the medicine inside the medicine storage part 51 to be discharged by breaking. A breaking operation part 55 is provided on the distal end side of the part 56 and is used to perform a breaking operation of the breakable part 56. The breakable portion 56 connects the inner surface of the distal end portion of the hollow drug storage portion 51 and the outer surface of the proximal end portion 59 of the proximal end portion 58 of the breakage operation portion 55, and is connected to the central axis of the drug storage portion 51. It is formed by a thin ring-shaped connecting portion 56 that is substantially orthogonal.

The hard medicine container 3b includes a lid part 7 that seals the opening of the medicine storage hollow body 5b. A flange portion 57a is provided at the base end of the medicine storage hollow body 5b, and the flange portion 57a is formed into a concave shape and has a lid attachment portion to which the lid portion 7 is attached. The lid portion 7 is liquid-tightly fixed to the lid attachment portion of the medicine storage hollow body 5b. The medicine accommodating portion 51 of the medicine accommodating hollow body 5b may be under normal pressure, or may be under reduced pressure or a vacuum state. In this manner, when the drug storage section 51 is in a reduced pressure or vacuum state, the effect of preventing alteration, decomposition, deterioration, etc. of the drug is improved.

As the medicine 9 to be stored, those mentioned above are preferably used.
Also in the drug storage hollow body 5b of this embodiment, the tip of the drug storage portion 51 is closed by the proximal end portion 58 of the breaking operation portion 55 and the breakable portion (thin ring-shaped connection portion) 56. The difference between the medicine storage hollow body 5b of this embodiment and the medicine storage hollow body 5 described above is only the configuration at the base end of the medicine storage hollow body 5b, which is described above. The parts including the annular recess 72, the annular inclined surface 74, etc., and having the same reference numerals as those of the medicine storage hollow body 5 described above are the same as the medicine storage hollow body 5 described above, and the above description should be referred to. do.
The cylindrical envelope member 6b is substantially the same as the cylindrical envelope member 6 described above. Portions including the annular inner rib 67 and the like and having the same reference numerals as those of the above-mentioned cylindrical covering member 6 are the same as those of the above-mentioned cylindrical covering member 6, and the above description will be referred to.

The constituent materials of the drug storage hollow body 5b, the cylindrical envelope member 6b, and the lid part 7 include hard polyvinyl chloride, polyethylene, polypropylene, polybutadiene, and cyclic polyolefin [specifically, ZEONEX (manufactured by Nippon Zeon Co., Ltd.)] , APEL (manufactured by Mitsui Chemicals, Inc.)], polypropylene homopolymer, polyolefin such as high-density polyethylene, polystyrene, poly-(4-methylpentene-1), polycarbonate, ABS resin, acrylic resin, polymethyl methacrylate (PMMA) , polyacetals, polyarylates, polyacrylonitrile, polyvinylidene fluoride, ionomers, acrylonitrile-butadiene-styrene copolymers, polyesters such as polyethylene terephthalate (PET), polybutylene terephthalate (PBT), butadiene-styrene copolymers, aromatics Alternatively, various resins such as aliphatic polyamide, or any combination thereof may be used. Among these, hard polyvinyl chloride, polyethylene, polypropylene, and polyester are preferred because they are highly safe and have excellent adhesion to the soft bag 2a.

Also in the infusion container 1a of this embodiment, by pressing the breaking operation part 55 of the hard drug container 3b, the thin ring-shaped connecting part 56 in the part facing the pressing part breaks, and the breaking part of the breaking operation part 55 breaks. enters into the drug accommodating portion 51 of the drug accommodating hollow body 5b, and the breaking operation portion 55 enters diagonally upward. Then, the annular inclined surface 74 of the annular recess 72 of the breaking operation section 55 comes into contact with the annular inner surface rib 67 of the cylindrical envelope member 6b, thereby preventing further entry. Then, the contact area between the annular inclined surface 74 of the breaking operation part 55 and the annular inner rib 67 of the cylindrical envelope member 6b becomes a fulcrum, and the breaking operation is continued, and the unbroken part of the thin ring-shaped connecting part 56 is Upon rupture, the rupture operation part 55 separates from the medicine storage hollow body 5b, the medicine storage part 51 opens, and the medicine in the hard medicine container 3b becomes able to flow out.

1, 1a Infusion container 2, 2a Soft bag 3, 3a, 3b Drug container 4 Needle tube invasion inhibiting member 5, 5a, 5b Hollow body for drug storage 6 Cylindrical encapsulant member 8 Sealing member (discharge port)
51 Drug storage part 55 Breaking operation part 56 Breakable part (thin ring-shaped connection part)
67 Annular inner rib

Claims (13)

An infusion container comprising a soft bag containing a drug solution, and a hard drug container attached to the soft bag and containing a drug to be mixed with the drug solution,
The drug container includes a drug storage hollow body and a drug stored in the drug storage hollow body,
The medicine storage hollow body includes a hollow medicine storage part, a breakable part, and a breaking operation part for performing a breaking operation of the breakable part extending in a distal direction from the breakable part, and the breaking operation part The portion has a proximal end portion located inside the distal end portion of the drug storage portion at the proximal end portion,
The breakable portion is located inside the distal end portion of the drug storage portion, connects the inner circumferential surface of the drug storage portion and the outer circumferential surface of the proximal end portion of the breakage operation portion, and The drug storage hollow body is formed by a thin ring-shaped connecting portion extending in a direction substantially perpendicular to the central axis, and the opening on the distal end side of the drug storage portion is unsealed by the thin ring-shaped connecting portion and the breaking operation portion. Further, the breaking operation part includes an annular recess located close to the thin ring-shaped connection part and on a distal end side of the thin ring-shaped connection part,
The drug container includes a cylindrical enveloping member coaxially enclosing the drug accommodating portion of the drug accommodating hollow body, and the cylindrical enveloping member covers the drug accommodating portion of the drug accommodating hollow body. An infusion container comprising: an annular inner rib located in front of the annular tip surface of the distal end portion and outside of the annular recess of the breaking operation portion. The cylindrical enveloping member encloses a proximal end portion of the breaking operation portion, and protects the broken end of the breakable portion and the soft portion of the proximal end portion of the breaking operation portion during a breaking operation of the breaking operation portion. The infusion container according to claim 1 , further comprising a cylindrical flexible enveloping portion that restricts contact with the inner surface of the bag. The annular inner surface rib of the cylindrical enveloping member cannot pass through the annular tip surface of the drug accommodating portion of the drug accommodating hollow body, and the portion in front of the annular recess of the breaking operation portion: The infusion container according to claim 1 or 2 , wherein the infusion container projects forward from the annular inner rib. When the breaking operation starts to break the thin-walled ring-shaped connection part, the breaking operation part of the breaking operation part enters into the medicine storage part of the medicine storage hollow body, and then the breakage part starts to break. The outer surface of the annular recess of the operating portion abuts the annular inner rib of the cylindrical enveloping member, thereby preventing further intrusion and continuing the breaking operation using the abutted portion as a fulcrum. 4. The infusion container according to any one of claims 1 to 3 , wherein the infusion container comprises: 5. The cylindrical envelope member according to claim 1 , wherein the cylindrical envelope member includes a cylindrical portion and a small-diameter tip portion having a smaller diameter than the cylindrical portion, and the annular inner rib is provided on the inner surface of the tip of the small-diameter tip portion. An infusion container according to any of the above. The drug accommodating hollow body extends toward a distal end side formed by an inner surface of the distal end portion of the drug accommodating portion, an outer surface of the proximal end portion of the breaking operation portion, and an inner surface of the thin ring-shaped connecting portion. The infusion container according to any one of claims 1 to 5 , comprising an inner annular recess. The breaking operation part has a proximal end part located inside the distal end part of the drug storage part, and the bottom surface of the proximal part is below the connection part with the thin ring-shaped connecting part. The infusion container according to any one of claims 1 to 6 , wherein the infusion container is located in the container. 8. The infusion container according to claim 1, wherein the drug container includes a sealing member to which a medical needle can be connected. A hard drug container,
The medicine container includes a medicine storage hollow body having a hollow medicine storage part, a sealing member that seals a rear end opening of the medicine storage hollow body, and a medicine stored in the medicine storage hollow body. , a cylindrical enveloping member coaxially enveloping the drug accommodating portion of the drug accommodating hollow body,
The medicine storage hollow body includes the medicine storage part, a breakable part, and a breaking operation part for performing a breaking operation of the breakable part that extends in a distal direction from the breakable part, and the breakage operation part has a proximal end portion located inside the distal end portion of the drug accommodating portion at the proximal end portion,
The breakable portion is located inside the distal end portion of the drug storage portion, connects the inner circumferential surface of the drug storage portion and the outer circumferential surface of the proximal end portion of the breakage operation portion, and The drug storage hollow body is formed by a thin ring-shaped connecting portion extending in a direction substantially perpendicular to the central axis, and the opening on the distal end side of the drug storage portion is unsealed by the thin ring-shaped connecting portion and the breaking operation portion. Further, the breaking operation part includes an annular recess located close to the thin ring-shaped connection part and on a distal side of the thin ring-shaped connection part,
The cylindrical enveloping member includes an annular inner rib located in front of the annular tip surface of the distal end portion of the drug accommodating portion of the drug accommodating hollow body and outside the annular recess of the breaking operation portion. A hard drug container characterized by: The annular inner surface rib of the cylindrical enveloping member cannot pass through the annular tip surface of the drug accommodating portion of the drug accommodating hollow body, and the portion in front of the annular recess of the breaking operation portion: The hard drug container according to claim 9, wherein the hard drug container projects forward from the annular inner rib. When the breaking operation starts to break the thin-walled ring-shaped connection part, the breaking operation part of the breaking operation part enters into the medicine storage part of the medicine storage hollow body, and then the breakage part starts to break. The outer surface of the annular recess of the operating portion abuts the annular inner rib of the cylindrical enveloping member, thereby preventing further intrusion and continuing the breaking operation using the abutted portion as a fulcrum. 11. The hard drug container according to claim 9 or 10. 12. The cylindrical envelope member according to claim 9, wherein the cylindrical envelope member includes a cylindrical portion and a small-diameter tip portion having a smaller diameter than the cylindrical portion, and the annular inner surface rib is provided on the inner surface of the tip of the small-diameter tip portion. A hard drug container according to any of the above.
Container for infusion. 13. The hard drug container according to claim 9, wherein the sealing member can be connected to a medical needle tube.

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