JP2017148228A - Medicament-prestored soft medical container and medicament administration appliance - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a soft medical container capable of preventing erroneous administration of medical liquid in a syringe filled with the medical liquid, and allowing a user to safely and easily prepare medicament administration by implementing a series of operations of mixing the medical liquid with a medicament and of connecting an injection needle to the syringe.SOLUTION: A medicament-prestored soft medical container 1 includes: a soft container body 2 having a medicament storage part 22; a medicament 5 stored in the medicament storage part; and a cylindrical member 4 fixed to the container body. The medical container 1 further includes: an injection needle 3 stored in the cylindrical member 4 such that a tip 33 faces the medicament storage part 22; a partition part 26 that releasably prevents communication of the inside of the cylindrical member 4 and the inside of the injection needle 3 to the medicament storage part 22; and a cylindrical-member encapsulation part 23 that shuts off the communication of the inside of the cylindrical member 4 and the inside of the injection needle 3 to the outside, and that can be opened.SELECTED DRAWING: Figure 3

Description

  The present invention relates to a drug-stored soft medical container and a drug administration device.

Conventionally, a drug in powder form or the like is sealed in a vial, and if necessary, a drug solution is mixed and dissolved by a syringe to create a drug solution, and the powder drug can be administered. As a method for producing such a drug solution, a syringe filled with a drug solution in an outer cylinder is used, and an injection needle attached to a nozzle of the outer cylinder of the syringe is used as a sealing member for a vial containing a powdered drug. Insert the plunger of the syringe in the direction of the nozzle at the tip of the outer cylinder, feed the drug solution into the vial, dissolve the powdered drug in the vial and mix it to make a drug solution, and then place the plunger of the syringe again at the proximal end of the syringe An operation of pulling in the direction is performed to inhale the drug solution created in the outer cylinder of the syringe so that the drug solution can be administered.
However, the operation for producing these chemicals is time-consuming and has the risk of contamination with foreign substances, contamination with bacteria, and injury to hands and fingers.

  In order to solve such problems, Japanese Patent Application Laid-Open No. 5-146510 (Patent Document 1) discloses a drug container in which a dissolving drug is accommodated and the mouth is sealed with a stopper, and the neck of the drug container. A connection outer cylinder fitted on the outer part, a protective cylinder fitted on the other end of the connection outer cylinder, a cylindrical solution container filled with a solution stored inside the protection cylinder, and an outer connection There has been proposed a press-injection type container that can be melted at the time of use, which is composed of a double-sided puncture needle that is fitted through a drug container side end wall of a connecting inner cylinder fitted inside the cylinder.

  Japanese Patent Laid-Open No. 10-323389 (Patent Document 2) discloses a syringe outer cylinder filled with a solution, a cylindrical adapter having a vial mounting portion at one end, an open cylinder adapter at both ends, a syringe outer cylinder, and a vial. Consists of a double-ended needle communicating with the vial attached to the attachment part, and the adapter is accommodated and supported near the vial attachment part, and a syringe outer cylinder is slidably inserted from the other end. A two-component mixing solution-filled syringe has been proposed in which the distal end portion is closed with a rubber cap, the proximal end portion is sealed with a gasket, and a communication sequence control means is configured between the double-ended needle and the adapter. Yes.

  Further, the applicant of the present application has proposed JP 2012-10930 A (Patent Document 3). The drug administration device 1 of Patent Document 3 includes a prefilled syringe 2 whose tip is sealed with a seal 16, a drug container 4 having a sealing member 42, and an outer cylinder side puncture 53 that can pierce the seal. And a communicating member 3 having a drug container side puncturing portion 54 that can pierce the sealing member 42. The sealing member 42 includes a drug administration member mounting portion 44 that extends into the container body 41 and can be mounted with the drug administration member. The drug administration device 1 releases the fixation between the sealing member and the container main body in a state where the outer cylinder side puncture portion 53 penetrates the seal portion 16 and the drug container side puncture portion 54 penetrates the sealing member 42. Thus, the drug administration member mounting portion 44 to which the injection needle can be mounted is exposed.

JP-A-5-146510 Japanese Patent Laid-Open No. 10-323389 JP 2012-10930 A

  In Patent Documents 1 and 2, a medical liquid (for example, a solution) filled in an outer cylinder of a syringe is overlooked as an administrable drug solution and is administered in a state where the drug is not dissolved. there is a possibility. In addition, it is difficult to easily recognize whether or not the puncture device communicates with the inside of the outer cylinder of the syringe and the inside of the medicine container, and the plunger of the syringe is operated while both are not in communication with each other. There is also a risk of leakage of the drug solution.

In the thing of patent document 3, after making the inside of the prefilled syringe filled with medical liquid and the inside of the chemical | medical agent container which accommodated the chemical | medical agent become an administration possible state, only the medical liquid in the state which does not add a chemical | medical agent misadministration Is effective. However, in order to administer the drug, it is necessary to connect the injection needle after adjusting the drug.
An object of the present invention is to prevent erroneous administration of a medical liquid in a syringe filled with a medical liquid (for example, a solution), and to mix the medical liquid with a drug, and to connect an injection needle to the syringe. In a series of operations, a drug-stored soft medical container that can be safely and easily prepared for drug administration and a drug administration device using the same are provided.

What achieves the above object is as follows.
(1) A soft medical container containing a medicine container having a medicine container, a medicine stored in the medicine container, and a cylindrical member fixed to the container body,
The medicine container of the container body is capable of injecting medical liquid,
The medical container releases the injection needle housed in the tubular member so that it can be taken out and the cutting edge faces the medicine housing portion side, the inside of the cylindrical member, the inside of the injection needle, and the medicine housing portion A drug-stored soft medical container having a partition section that can be partitioned.

(2) The injection needle includes a hollow needle having the cutting edge at a distal end, and an injection needle hub fixed to a proximal end portion of the hollow needle, and the cylindrical member includes the injection needle and the injection needle hub. The medicine-contained medical container according to (1), which is stored in a state in which a syringe can be connected to the rear end opening of the medicine.
(3) The cylindrical member is provided with an elastic seal member that is in close contact with the outer surface of the hollow needle in an annular and liquid-tight manner and that allows the hollow needle to slide. Medical container.
(4) The soft container main body is a thermoplastic soft container main body, and the partition portion is formed by a peelable weak seal portion formed in the soft container main body. A soft medical container containing the medicine according to any one of the above.
(5) The soft medical container in which the medicine is stored according to (4), wherein the weak seal portion is peeled off by the medical liquid flowing out from the injection needle.
(6) The medical container includes a small volume gap formed between the weak seal portion of the container body and the elastic seal member of the cylindrical member, and the volume of the small volume gap is 0.1. The soft medical container in which the medicine is stored according to (4) or (5), which is ˜5 ml.
(7) The drug-stored soft according to any one of (4) to (6), wherein the weak seal portion includes an easy-release portion provided at a site in front of the cutting edge of the injection needle. Medical container.

(8) The medicine storing soft medicine according to any one of the above (1) to (3), wherein the partitioning portion is formed by a sealing member provided at an end portion of the cylindrical member on the medicine storing portion side. Container.
(9) The injection needle is accommodated in the cylindrical member so as to be movable in the direction of the medicine accommodating portion, and the sealing member is piercable by the injection needle or opened by the injection needle. The drug-stored soft medical container according to (8), which is a possible film or sheet.
(10) The injection needle is housed in the cylindrical member so as to be movable in the direction of the medicine housing portion, and the sealing member is an elastic member through which the injection needle can be pierced The soft medical container in which the medicine is stored according to (8).

(11) The medical container includes a cylindrical member encapsulating portion that blocks communication between the inside of the cylindrical member and the inside of the injection needle and the outside and is openable. 10) The soft medical container in which the medicine is stored according to any one of 10).
(12) The drug-stored soft medical container according to (11), wherein the cylindrical member encapsulating part is a soft bag-like encapsulating part that is integral with or fixed to the container body.
(13) In the above (11), the cylindrical member-encapsulating portion is an openable cap member attached to the flexible container body or the cylindrical member so as to encapsulate an end portion of the cylindrical member. A soft medical container containing the medicine.
(14) In the above (13), the cap member includes a tubular fixing portion fixed to the container main body, a cap portion, and a fragile weak portion for connecting the cylindrical fixing portion and the cap portion. A soft medical container containing the medicine.

Moreover, what achieves the said objective is as follows.
(15) A drug administration device comprising the soft medical container in which the drug is stored according to any one of (1) to (14), and a prefilled syringe filled with the medical liquid.

The drug-stored soft medical container of the present invention includes a soft container main body having a drug storage section, a drug stored in the drug storage section, and a cylindrical member fixed to the container main body. The medicine storage part of the container body can inject medical liquid. The medical container includes an injection needle stored in the cylindrical member so that the blade edge faces the drug storage unit side, a partition unit that releasably partitions the inside of the cylindrical member and the injection needle and the drug storage unit, A cylindrical member encapsulating portion that blocks communication between the inside of the cylindrical member and the inside of the injection needle and the outside and is openable.
In the soft medical container in which the medicine is stored according to the present invention, it is necessary to prepare a syringe filled with a medical liquid in preparation for drug administration, but it is not necessary to attach an injection needle. Misadministration does not occur. Then, after opening the cylindrical member enveloping part, connection of the liquid-filled syringe to the injection needle, release of the partition part, injection of the medical liquid in the syringe into the medicine container of the medical container, medical use with the medicine After mixing the liquid and sucking the drug mixture into the syringe, the syringe connected to the injection needle was removed from the medical container, so that the injection needle was attached and the drug mixture was filled inside. A dosage form of the syringe can be obtained. Therefore, preparation for drug administration can be performed safely and easily.
In addition, since the drug administration device of the present invention includes the above-described soft medical container in which the drug is stored and a prefilled syringe filled with medical liquid, the syringe, the injection needle and the absorbent cotton are prepared, the needle is attached and detached, and the absorbent cotton. The sterilization operation by the above and the suction operation of the medical liquid into the disposable syringe are unnecessary, and by performing as described above, a syringe with a dosage form in which the drug mixture is filled can be obtained.

FIG. 1 is a front view of one embodiment of a soft medical container in which a medicine is stored according to the present invention. 2 is a cross-sectional view taken along line AA in FIG. 3 is a cross-sectional view taken along line BB in FIG. FIG. 4 is an explanatory diagram for explaining the operation of the soft medicine container in which the medicine is stored shown in FIGS. 1 to 3. FIG. 5 is an explanatory diagram for explaining the operation of the soft medical container in which the medicine is stored shown in FIGS. 1 to 3. FIG. 6 is an explanatory diagram for explaining the operation of the soft medical container in which the medicine is stored shown in FIGS. 1 to 3. FIG. 7 is a front view of another embodiment of the soft medicine container in which the medicine is stored according to the present invention. FIG. 8 is a vertical cross-sectional view of the soft medicine container with medicine stored therein shown in FIG. FIG. 9 is an explanatory diagram for explaining the operation of the soft medical container in which the medicine is stored shown in FIGS. 7 and 8. Fig. 10 is a front view of another embodiment of the soft medicine container with medicine stored therein according to the present invention. FIG. 11 is a longitudinal sectional view of the soft medical container in which the medicine is stored shown in FIG. FIG. 12 is a longitudinal sectional view of another embodiment of the soft medicine container with medicines stored therein according to the present invention. FIG. 13 is a vertical cross-sectional view of another embodiment of the soft medicine container with medicine stored therein according to the present invention. FIG. 14 is an explanatory diagram for explaining the operation of the soft medical container in which the medicine is stored shown in FIG. FIG. 15 is a longitudinal cross-sectional view of another embodiment of the soft medicine container with medicine stored therein according to the present invention. FIG. 16 is a longitudinal cross-sectional view of another embodiment of the soft medicine container with a medicine stored therein according to the present invention. FIG. 17 is an explanatory diagram for explaining the operation of the soft medical container in which the medicine is stored shown in FIG. FIG. 18 is a longitudinal sectional view of an example of a prefilled syringe used in the drug administration device of the present invention.

The drug-stored soft medical container of the present invention will be described with reference to the embodiments shown in the drawings.
The drug-stored soft medical container 1 of the present invention includes a soft container main body 2 having a drug storage section 22, a drug 5 stored in the drug storage section 22, and a cylindrical member 4 fixed to the container main body 2. Prepare. The medicine container 22 of the container body 2 can inject the medical liquid 16. In the medical container 1, the injection needle 3 stored in the cylindrical member 4 so that the cutting edge 33 faces the drug storage unit 22, and the communication between the cylindrical member 4 and the injection needle 3 and the drug storage unit 22 are provided. And a cylindrical member encapsulating portion 23 that blocks communication between the inside of the cylindrical member 4 and the injection needle 3 and the outside and can be opened.

  Moreover, the medicine administration device of the present invention includes the above-described soft medical container 1 containing medicine and the prefilled syringe 10 filled with the medical liquid 16 as shown in FIG.

The soft medicine container 1 with medicine stored in the embodiment shown in FIGS. 1 to 3 includes a soft container body 2, a tubular member 4 fixed to the container body 2, and an injection needle housed in the tubular member 4. 3.
In the soft medicine container 1 with medicine stored in this embodiment, the soft container body 2 includes a main body portion 21 having a medicine storage portion 22 and a cylindrical member encapsulating portion 23 extending upward from the main body portion 21.

As shown in FIGS. 1 to 3, the soft container body 2 has a seal portion 27 formed on the peripheral edge of the soft container body 2. And it has the medicine storage part 22 formed by the seal part 27 of the main body part 21. An end accommodating portion of the cylindrical member 4 is formed by the seal portion 27 of the cylindrical member encapsulating portion 23.
The soft container body 2 is formed of a soft synthetic resin. The soft container body 2 is preferably formed into a cylindrical shape by an inflation molding method. The soft container body 2 may be manufactured by various methods such as a blow molding method and a coextrusion inflation method.

  As a material for forming the soft container body 2, for example, polyethylene (PE), polypropylene (PP), polybutadiene, polyolefin such as cyclic polyolefin, various thermoplastic elastomers such as olefin elastomer, styrene elastomer, or any combination thereof. (Blend resin, polymer alloy, laminate, etc.).

  The material for forming the soft container body 2 preferably contains polyolefin. As a material for forming the flexible container body 2, particularly preferable is polyethylene, polypropylene, styrene-based thermoplastic elastomer such as styrene-butadiene copolymer or styrene-ethylene-butylene-styrene block copolymer, or ethylene-propylene copolymer. Examples thereof include a soft resin obtained by blending an olefin-based thermoplastic elastomer such as a polymer, an ethylene-butene copolymer, and a propylene-α-olefin copolymer. This material has high strength and flexibility, high heat resistance (especially heat resistance during sterilization), high cold resistance (transport and storage in cold regions), excellent transparency, and excellent processability, manufacturing cost It is preferable at the point which can aim at reduction.

  The soft container body 2 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) may be stacked for various purposes. A multilayer laminate may also be used. 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 of a laminate of a plurality of resin layers, it can have the advantages of each resin. For example, the impact resistance of the soft container body 2 can be improved, blocking resistance, transparency, flexibility, heat resistance, etc. Can be added. Further, when a layer made of an oxide such as titanium oxide, aluminum oxide, or silicon oxide is provided as a layer other than the innermost layer, the gas barrier property can be improved and the transparency of the flexible container body 2 can be maintained. Visibility can be ensured.

The thickness of the sheet material constituting the soft container body 2 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, it is preferably about 100 to 500 μm, more preferably about 200 to 360 μm.
In addition, the volume of the soft container body 2, in other words, the volume of the medicine container varies depending on the amount of medical liquid to be injected, such as the kind of medicine stored inside, but usually 0.5 to 100 ml. It is preferable that it is a grade, and 0.5-10 ml is especially preferable.

  The soft container body 2 includes a cylindrical member 4 fixed to the container body 2 so as to communicate with the inside of the container body 2. The cylindrical member 4 houses the injection needle 3 therein. As the tubular member 4, a rigid member made of a tubular thermoplastic resin is used. As a forming material of the cylindrical member 4, a material in which at least an outer surface is formed of a thermoplastic resin having heat-fusibility with the soft container body 2 is preferable. Specifically, examples of the forming material include polyolefins such as polyethylene, polypropylene, cyclic polyolefin, and ethylene-propylene copolymer, polyesters such as polyethylene terephthalate and polybutylene terephthalate, and styrene resins such as polystyrene and MS resin ( A thermoplastic synthetic resin such as polyvinyl chloride, polyamide, such as 6 nylon or 66 nylon, such as methacrylate-styrene copolymer) or MBS resin (methacrylate-butylene-styrene copolymer) is used. In the soft medical container 1 of this embodiment, the tubular member 4 is fixed to the soft container body 2 by the heat seal portion 25.

  The injection needle 3 includes a hollow needle 31 having a cutting edge 33 at the tip, and an injection needle hub 32 fixed to the proximal end portion of the hollow needle 31. The injection needle hub 32 has a luer taper on the inner surface to which the tip portion of the prefilled syringe 10 can be attached. The hub 32 is provided with a rib for attachment to the syringe at the rear end. And the rib provided in the hub 32 is equipped with the collar 13 formed concentrically with the nozzle part 12 like the prefilled syringe 10 mentioned later, and the thread groove (outer cylinder side screwing part) formed in the inner surface. In the case of connecting to the pre-filled syringe, the rib and the above-mentioned thread groove (external cylinder side screwing portion) are engaged with each other at the time of mounting, thereby restricting the detachment of the injection needle (hub) from the prefilled syringe.

  The cylindrical member 4 stores the injection needle 3 in a state in which the syringe 10 can be connected to the rear end opening of the injection needle hub 32. Specifically, the cylindrical member 4 accommodates the injection needle 3 with the rear end opening of the injection needle hub exposed. Specifically, the cylindrical member 4 includes a cylindrical main body portion 41, a hollow needle storage portion 42 that has a smaller diameter and extends downward from the main body portion 41 by a predetermined length, an inner diameter that is larger than the main body portion 41, and an opening. A proximal end 44 having an end is provided. The hollow needle storage portion 42 is inserted into the mouth portion of the soft container main body 2 and fixed by the seal portion 25. The tubular member 4 has a stepped portion 43 on the inner surface of the boundary portion between the main body portion 41 and the base end portion 44. The injection needle hub 32 has a hollow main body portion and a tip portion having a smaller diameter than the hollow main body portion. The injection needle 3 housed in the tubular member 4 has a hollow needle 31 held by the elastic seal member 6, and the tip of the cutting edge 33 is located near the tip of the tubular member 4. Further, the hub 32 of the injection needle 3 has a stepped portion 43 with the small-diameter portion at the tip of the main body, and can abut on the tip of the base end 44 of the cylindrical member 4 (the boundary with the main body 41). Therefore, further movement of the injection needle 3 in the tip direction (partition direction) is obstructed.

  Further, the cylindrical member 4 is provided with a cylindrical elastic seal member 6 that is in close contact with the outer surface of the hollow needle of the injection needle 3 in an annular and liquid-tight manner and allows the hollow needle to slide. The base end portion of the elastic seal member 6 has a tapered inner surface whose diameter increases toward the base end side, so that the cutting edge 33 of the injection needle 3 can be easily inserted. The elastic seal member 6 is preferably a rubber material or an elastomer. Rubber materials include isoprene rubber, butyl rubber, isobutyl rubber, natural rubber, styrene-butadiene copolymer rubber, polybutadiene rubber, ethylene-propylene rubber, ethylene-propylene-diene terpolymer rubber, silicone rubber and fluorine rubber. Is mentioned. Examples of the elastomer include various thermoplastic elastomers such as an olefin elastomer and a styrene elastomer. The elastic seal member 6 is preferably fixed to the inner surface of the cylindrical member 4 so as not to move.

And the soft medical container 1 has the partition part 26 provided in the soft container main body 2. FIG. The partition part 26 obstruct | occludes communication in the cylindrical member 4 and the injection needle 3, and the chemical | medical agent storage part 22 so that cancellation | release is possible. In the soft medical container 1 of this embodiment, the soft container main body 2 uses the thermoplastic soft container main body 2, and the partition portion 26 is formed by a peelable weak seal portion formed on the soft container main body 2. Has been.
In this embodiment, the weak seal portion that forms the partition portion 26 is formed so as to surround the upper front of the end portion of the cylindrical member 4 on the drug storage portion side. By this weak seal part, the inside of the cylindrical member 4 and the inside of the injection needle 3 do not communicate with the medicine storage part 22.

The weak seal part (partition part) 26 is formed by heat-sealing the sheet material forming the soft container body 2 in a band shape (thermal fusion, high-frequency fusion, ultrasonic fusion, etc.). The weak seal portion is preferably formed by a hot press, and the mold temperature is preferably formed at a temperature lower by 10 ° C. or more than the melting temperature of the forming material of the soft container body 2.
In the embodiment shown in FIG. 1, the weak seal portion (partition portion) 26 is formed in an inverted U shape. In addition, the weak seal portion has a trapezoidal shape with the short side on the upper side, 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. It may be.

  The drug stored in the drug storage section may be any solid, liquid or the like, such as powder or granule, as long as it is mixed with medical liquid at the time of use. As the medical liquid, a diluting solution and a dissolving solution are preferably used. As the diluting solution and the dissolving solution, water for injection (distilled water for injection), physiological saline, sodium chloride solution, glucose solution, Ringer's solution and infusion solution, amino acid solution, lidocaine solution, xylitol solution and the like are used. Drugs include antibiotics, vitamins (general vitamins), various amino acids, antithrombotics such as heparin, hemorrhoids, blood products such as plasma fractions, insulin, vaccines, antitumor agents, analgesics, sedation Agent, cardiotonic agent, intravenous anesthetic agent, ulcer treatment agent, muscle relaxant, hormone agent such as hypothalamic hormone agent and corticosteroid, arrhythmia agent, correction electrolyte, antiviral agent, immunostimulant, infertility agent, diagnosis Test reagents and the like.

The soft medical container 1 of this embodiment includes a small-capacity gap formed between the weak seal portion of the container body 2 and the elastic seal member of the tubular member 4. Specifically, the small-capacity gap portion includes the inner surface of the container body 2 on the cylindrical member side from the partition portion (weak seal portion) 26, the end surface on the partition portion 26 side of the elastic seal member 6, and the distal end portion of the injection needle 3. It is formed by the outer surface. The volume of the small-capacity gap is preferably 0.1 to 5 ml, and particularly preferably 0.1 to 1 ml. Although there is a limit of formation as a small-capacity void, the smaller the void volume, the easier it is to open due to the injection pressure.
In the soft medical container 1 of this embodiment, the medical liquid 16 is injected from the injection needle 3 into the small-capacity gap, in other words, by the medical liquid 16 that is press-fitted from the injection needle 3. The partition part (weak seal part) 26 peels off.

And in this Example, in order to make peeling of the partition part (weak seal part) 26 easy, it has the easy peeling part 26a provided in the site | part which becomes the front of the blade edge | tip 33 of the injection needle 3. FIG. . The easy peeling part 26a is narrower than the other part of the partition part (weak seal part). Furthermore, the easy peeling part 26a of this example is a thing with a narrow width | variety by the recessed part formed in the injection needle side. The peel strength of the partition part (weak seal part) 26 is preferably 7 to 12N, and particularly preferably 7 to 10N.
The weak seal part (partition part) 26 may be peeled off by pressing the medicine storage part 22. In this case, it is preferable that the medicine container 22 is filled with a gas for separating the partition (for example, air or nitrogen).

  The injection needle 3 is stored such that the cutting edge 33 protrudes from the elastic seal member 6 and faces the medicine storage portion 22 side, in other words, the partition portion 26 side (weak seal portion side). And it is preferable that the distance between the front-end | tip of the blade edge | tip 33 of the injection needle 3 and the partition part 26 (weak seal part) is 0.5-20 mm, and it is especially preferable that it is 1.0-10 mm. The injection needle 3 housed in the tubular member 4 is held by the elastic seal member described above, and does not move unless pressed.

  And in the soft medical container 1 of this Example, the part which protrudes from the main-body part 21 of the container main body 2 of the cylindrical member 4, and the part which protrudes from the cylindrical member 4 of the injection needle 3 are soft cylindrical member covers. It is encapsulated by the enveloping part 23. The soft cylindrical member encapsulating portion 23 is formed integrally with the soft container body 2. The soft cylindrical member encapsulating portion 23 may be made of a separate member and fixed to the soft container body 2. The cylindrical member encapsulation part 23 of this embodiment is a soft bag-shaped encapsulation part. The cylindrical member-encapsulating part 23 includes a notch part 24 for opening (for breaking) on the side part. The notch 24 is preferably provided between the notches 24 at a position where the hub 32 of the injection needle 3 is exposed when the encapsulating part 23 is broken. Moreover, the cylindrical member enveloping part 23 may be opened by peeling.

Further, in the soft medical container 1 and the drug administration device using the same according to the present invention, a prefilled syringe 10 filled with a medical liquid 16 as shown in FIG. 18 is used.
The prefilled syringe 10 includes a medical liquid 16 filled in a space formed by an outer cylinder 11, a gasket 14, and a seal cap 18 that is a sealing member.
The syringe outer cylinder 11 is a cylindrical body formed of a transparent or translucent material, preferably a material having low oxygen permeability and water vapor permeability.

The outer cylinder 11 includes an outer cylinder main body part, a nozzle part 12 provided on the front end side of the outer cylinder main body part, and a flange 17 provided on the rear end side of the outer cylinder main body part.
The outer cylinder main body part is a substantially cylindrical part that accommodates the gasket 14 in a liquid-tight and slidable manner, and the nozzle part 12 is a cylindrical part having a smaller diameter than the outer cylinder main body part. Moreover, the front-end | tip part of an outer cylinder main-body part is a taper part which diameter-reduces toward a nozzle part. The outer cylinder 11 includes a collar 13 formed concentrically with the nozzle portion 12.

On the inner peripheral surface of the collar 13, there are formed a rib formed in the nozzle housing portion of the sealing member (seal cap) 18 and a screw groove (outer tube side screwing portion) for engaging with the above-described injection needle hub 32. I have. Thereby, the outer cylinder 11 and the seal cap 18 are engaged between the collar inner peripheral surface and the nozzle housing portion outer peripheral surface. Further, the thread groove (outer tube side screwing portion) is a portion to which the hub 32 of the injection needle is attached after the seal cap 18 is removed from the outer tube.
Examples of the material for forming the outer cylinder 11 include polypropylene, polyethylene, polystyrene, polyamide, polycarbonate, polyvinyl chloride, poly- (4-methylpentene-1), acrylic resin, acrylonitrile-butadiene-styrene copolymer, polyethylene terephthalate. And various resins such as polyester, cyclic polyolefin polymer, and cyclic olefin copolymer.

  As shown in FIG. 18, the sealing member (seal cap) 18 has a closed end, a cylindrical main body portion, and a nozzle storage portion formed in the cylindrical portion. Further, the nozzle storage portion includes a portion for storing the tip portion of the nozzle portion 12 and a portion for storing the tip portion of the collar 13. The forming material of the sealing member (seal cap) includes elastic materials such as synthetic rubbers such as natural rubber, isoprene rubber, butyl rubber, butadiene rubber, fluorine rubber, and silicone rubber, and thermoplastic elastomers such as olefin elastomer and styrene elastomer. Is preferred.

  As shown in FIG. 18, the gasket 14 includes a cylindrical main body portion that extends with substantially the same outer diameter, and a tapered blocking portion that extends in the distal direction from the main body portion. A plurality of annular ribs (three or two or more in this embodiment may be used as long as liquid tightness and slidability are satisfied) are formed on the outer surface of the main body. . These ribs are in liquid-tight contact with the inner surface of the outer cylinder 11. Further, the closed portion of the gasket 14 has a shape corresponding to the shape of the inner surface of the distal end of the outer tube 11 so as not to form a gap as much as possible when contacting the inner surface of the distal end of the outer tube 11.

  And the gasket 14 is provided with the recessed part which is the inside of a cylindrical main-body part, and extends in a front-end | tip direction from a rear-end opening part. In this recess, a plunger mounting portion to which the tip of the plunger 15 can be mounted is formed. In this embodiment, a gasket-side threaded portion is formed on the inner surface of the recess. The gasket side screwing portion can be screwed with the plunger side screwing portion formed on the outer surface of the protruding portion formed at the tip of the plunger 15.

  As a material for forming the gasket 14, elastic rubber (for example, butyl rubber, latex rubber, silicone rubber, etc.), synthetic resin (for example, styrene elastomer such as SBS elastomer, SEBS elastomer, ethylene-α olefin copolymer elastomer, etc.) It is preferable to use olefin-based elastomers).

As shown in FIG. 18, the plunger 15 includes a plunger main body portion and a front end portion for mounting on the gasket 14 protruding from the plunger main body portion in the front end direction. The plunger main body portion includes a flange portion, a pressing portion, and a reinforcing portion.
As a constituent material of the plunger 15, it is preferable to use a hard or semi-hard resin such as high-density polyethylene, polypropylene, polystyrene, polyacetal, polyethylene terephthalate.
Examples of the medical liquid 16 filled in the prefilled syringe include water for injection (distilled water for injection), physiological saline, sodium chloride solution, glucose solution, Ringer's solution and infusion solution that can be used as a solution or diluent. An electrolyte solution, an amino acid solution, a lidocaine solution, a xylitol solution, or the like is used.

Next, the operation of the soft medical container 1 of the present invention will be described with reference to FIGS.
The medicine-stored soft medical container 1 and the prefilled syringe 10 described above are prepared. Then, the tubular member-encapsulating portion 23 is broken from the cutout portion 24 so that the injection needle hub 32 is exposed. Moreover, the cap 18 of the prefilled syringe 10 is removed. Then, as shown in FIG. 4, the prefilled syringe 10 is connected to the exposed injection needle hub 32. Subsequently, the plunger 15 is pressed, and the medical liquid 16 in the syringe 10 is injected into a small gap portion in the container body 2 formed between the partition portion (weak seal portion) 26 and the elastic seal member 6, and FIG. As shown in FIG. 2, the liquid is filled in the small gap portion. Further, the plunger 15 is pressed to apply pressure in the small gap. Thereby, the partition part 26 peels and the small space | gap part and the chemical | medical agent storage part 22 are connected. Then, the liquid 16 flows into the medicine container 22. As shown in FIG. 5, after a required amount of liquid 16 is injected into the medicine storage unit 22, the stored medicine 5 and the injected liquid 16 are mixed. Then, the plunger 15 of the syringe 10 is pulled, and a drug mixture 16a that is a mixture of the liquid 16 and the drug 5 in the soft medical container 1 is sucked into the syringe. After suction, the syringe 10 is detached from the soft medical container 1 together with the injection needle 3. Thereby, as shown in FIG. 6, the syringe of the administration form with which the injection needle 3 was mounted | worn and the inside of the chemical | medical agent liquid mixture 16a was filled can be obtained.

Next, a soft medical container 1a according to another embodiment of the present invention shown in FIGS. 7 and 8 will be described.
The difference between the soft medical container 1a of this embodiment and the soft medical container 1 described above is only the configuration of the outer surface of the cylindrical member encapsulating portion and the rear end portion of the cylindrical member. Other parts are the same as those of the soft medical container 1 described above. The soft container main body 2a is the same as the soft container main body 2 described above except that it does not have the bag-shaped cylindrical member encapsulating portion 23.
In this soft medical container 1a, the cylindrical member enclosing portion 8 is an openable cap member attached to the soft container main body 2a so as to enclose the end of the cylindrical member 4a. Specifically, the cylindrical member encapsulating portion 8 is formed by a cap member fixed to the flexible container main body 2a so as to enclose the entire rear end portion (a portion protruding from the container main body 2a) of the cylindrical member 4a. It is configured. And the cylindrical member enveloping part 8 which is a cap member is shown in FIG.7 and FIG.8, The cylindrical fixing | fixed part 83 fixed to the soft container main body 2a, the cap part 81, and the cylindrical fixing | fixed part 83 And a fragile portion 84 for breaking connecting the cap portion 81.

  And the cap part 81 is provided with the hub encapsulation part 82 which encapsulates the injection needle hub 32 which protrudes from the cylindrical member 4a. Further, in this embodiment, the tubular member 4a includes a rib 46 provided on the outer surface of a portion protruding from the soft container body 2a and a portion adjacent to the outer edge of the soft container body 2a. The cylindrical fixing portion 83 of the cylindrical member encapsulating portion 8 includes a slit that accommodates the rib 84. Due to the engagement between the ribs 84 and the slits, the tubular member encapsulating portion 8 is not rotated with respect to the tubular member 4a.

  Moreover, as shown in FIG. 8, the cylindrical member 4a has a cylindrical member side threaded portion (specifically, a male screw portion) 45 provided on the outer surface of the base end portion (rear end portion). The cap portion 81 has a cap-side screwing portion (specifically, a female screw portion) 86 that can be screwed with the cylindrical member-side screwing portion 45 of the cylindrical member 4a on the inner surface. The tubular fixing portion 83 has an annular inner rib 87 provided on the inner surface, and the tubular member 4 a includes an annular outer surface rib 48 that can be engaged with the annular inner rib 87. When the annular inner rib 87 of the tubular fixing portion 83 of the tubular member encapsulating portion 8 gets over the annular outer surface rib 48 of the tubular member 4a, they are engaged with each other. It does not detach from the member 4a.

  The cap portion 81 is formed in the vicinity of the hub storage portion 82, and the end portion storage portion of the cylindrical member 4 a that is an annular space formed between the inner surface of the cap portion 81 and the cylindrical protrusion of the hub storage portion 82. It has. In the state where the annular inner rib 87 of the tubular fixing portion 83 of the tubular member enclosing portion 8 and the annular outer surface rib 48 of the tubular member 4 a are engaged, the end of the tubular member 4 a It is stored in an airtight state in the cylindrical member end storage section.

  In the soft medical container 1a of this embodiment, the entire portion of the cylindrical member 4a protruding from the container main body 2a is encapsulated by the encapsulating portion 8, and is not exposed. Then, by twisting the cap part 81 of the encapsulating part 8, as shown in FIG. 9, the breaking weak part 84 is broken, the cap part 81 is detached from the cylindrical fixing part 83, and the cylindrical member 4a The end portion and the injection needle hub 32 are exposed, and the prefilled syringe can be connected.

  As a forming material of the cylindrical member encapsulating portion 8, polyolefin, for example, polyethylene, polypropylene, cyclic polyolefin, ethylene-propylene copolymer, etc., polyester, for example, polyethylene terephthalate, polybutylene terephthalate, etc., styrene resin, for example, polystyrene, Thermoplastic synthetic resins such as MS resin (methacrylate-styrene copolymer), MBS resin (methacrylate-butylene-styrene copolymer), polyvinyl chloride, polyamide such as 6 nylon and 66 nylon are used.

Next, a soft medical container 1b according to another embodiment of the present invention shown in FIGS. 10 and 11 will be described.
The difference between the soft medical container 1b of this embodiment and the soft medical container 1 described above is only the configuration of the outer surface of the cylindrical member encapsulating portion and the rear end portion of the cylindrical member. Other parts are the same as those of the soft medical container 1 described above. Further, the difference between the soft medical container 1b of this embodiment and the above-described soft medical container 1a is only the configuration of the cylindrical fixing portion of the cylindrical member encapsulating portion, and the other portions are described above. The same as the medical container 1a.

  In the soft medical container 1b of this embodiment, as shown in FIGS. 10 and 11, the cylindrical member encapsulating portion 8b which is a cap member includes a cylindrical fixing portion 83b fixed to the soft container main body 2a, and a cap. A breakable weak portion 84 that connects the portion 81, the cylindrical fixing portion 83b, and the cap portion 81 is provided. The cylindrical fixing portion 83 b constitutes a so-called tamper evidence band having a grip portion 88. By holding the grip portion 88 and pulling it strongly, the breakable weak portion 84 that is continuous with the grip portion 88 is broken, and subsequently, by pulling the grip portion 88 along the outer peripheral surface of the tubular member 4b, The cylindrical fixing portion 83b is detached from the cap portion 81 and also from the tubular member 4b. When the cylindrical fixing portion 83b is detached from the cap portion 81, the cap portion 81 is also detached from the tubular member 4b, and the entire tubular member encapsulating portion 8 is detached from the soft medical container 1b. Thereby, the edge part of the cylindrical member 4b and the injection needle hub 32 will be exposed, and it will be in the state which can connect a prefilled syringe.

Next, a soft medical container 1c according to another embodiment of the present invention shown in FIG. 12 will be described.
The difference between the soft medical container 1c of this embodiment and the soft medical container 1 described above is only the configuration of the outer surface of the cylindrical member encapsulating portion and the rear end portion of the cylindrical member. Other parts are the same as those of the soft medical container 1 described above.
In this soft medical container 1c, the cylindrical member enclosing portion 8c is an openable (detachable) cap member attached to the soft container main body 2a so as to enclose the end of the cylindrical member 4c. Yes. Specifically, the cylindrical member enclosing portion 8c is configured by a cap member attached to the cylindrical member 4c so as to enclose the rear end portion of the cylindrical member 4c.

  As shown in FIG. 12, the cylindrical member encapsulating portion 8c, which is a cap member, includes a cap portion 81 and a hub encapsulating portion 82 that encapsulates the injection needle hub 32 protruding from the cylindrical member 4c. Yes. Further, the cylindrical member enveloping portion 8 c has an annular inner rib 89 provided on the inner surface of the lower end portion, and the cylindrical member 4 c has an annular outer surface recess 49 that can be engaged with the annular inner rib 89. I have. The annular inner rib 89 of the cylindrical member encapsulating portion 8c enters the annular outer surface concave portion 49 of the cylindrical member 4c so that they are engaged, and the cylindrical member encapsulating portion 8c is separated from the cylindrical member 4c. It is something that will not leave.

  The cylindrical member enclosing portion 8c is formed in the vicinity of the hub accommodating portion 82, and the cylindrical member 4c is an annular space formed between the inner surface of the cap portion 81 and the cylindrical protruding portion 85 of the hub accommodating portion 82. End storage section. In the state where the above-described annular inner rib 89 of the cylindrical member enclosing portion 8 c and the annular outer surface concave portion 49 of the cylindrical member 4 c are engaged, the end portion 98 of the cylindrical member 4 c is the cylindrical member of the cap portion 81. It is stored in the end storage section in an airtight state.

  In the soft medical container 1c of this embodiment, a part of the portion of the cylindrical member 4c that protrudes from the container body 2a is exposed. Then, by removing the cylindrical member encapsulating portion 8c from the cylindrical member 4c, the end portion of the cylindrical member 4c and the injection needle hub 32 are exposed, and the prefilled syringe can be connected.

In all the embodiments described above, the partition portion may be a partition portion of the type provided in the soft medical container 1d of the embodiment shown in FIGS.
In the soft medical container 1d of this embodiment, the partition portion is formed by a sealing member 9 provided at the end of the cylindrical member 4d on the drug storage portion side. In the soft medical container 1d of this embodiment, the injection needle 3 is accommodated in the cylindrical member 4d so as to be movable in the direction of the medicine accommodating portion 22. Further, the sealing member 9 can be pierced by the injection needle 3 or can be opened by the injection needle 3.
The cylindrical member encapsulation portion 8d is the same as the cylindrical member encapsulation portion 8 described above except that the hub encapsulation portion is slightly longer. In addition, the cylindrical member encapsulation part 8d may be the other types of cylindrical member encapsulation parts 8a, 8b, and 8c described above.

  The sealing member 9 of this embodiment is formed of a film or sheet that can be pierced by the injection needle 3, and the peripheral edge thereof is liquid-tightly fixed to the end of the cylindrical member 4d. As the sealing member 9, for example, a film made of a thermoplastic resin such as polyethylene, polypropylene, polybutadiene, polyolefin such as cyclic polyolefin, polyester, polyamide or the like, or a laminate thereof can be suitably used.

  And as shown in FIG. 14, the injection needle 3 is accommodated in the cylindrical member 4d so as to be movable in the direction of the medicine accommodating portion 22, and by moving, the cutting edge 33 of the injection needle 3 becomes a partition portion. 9 is pierced, and the inside of the injection needle 3 communicates with the inside of the medicine container of the container body 2b. Specifically, as shown in FIG. 14, the cylindrical member encapsulating portion 8d is unsealed, the cap portion 81 is detached, the prefilled syringe 10 is attached to the exposed injection needle hub 32, and then the prefilled syringe 10 is used as a medicine. By pushing in the direction of the container body 2b, the injection needle 3 penetrates the partition part 9, and communicates the inside of the injection needle 3 and the medicine storage part 22 of the container body 2b. Thereby, the medical liquid in the prefilled syringe 10 can be injected into the medicine container 22.

  Further, the partition portion is not limited to the film or sheet as described above, and may be an elastic member that can pierce the injection needle 3 provided in the soft medical container 1e of the embodiment shown in FIG. Good. In the soft medical container 1e of this embodiment, the partition 90 has a cap shape, and is attached to the lower end opening of the tubular member 4d so as not to be detached.

  Moreover, in the soft medical container 1e of this embodiment, the cap-shaped partitioning portion 90 has a flat plate portion 91, a short cylindrical portion extending from the flat plate portion 91, and an annular rib 92 formed on the inner surface thereof. . And the cylindrical member 4d has the annular recessed part 93 in the front-end | tip part side surface of a lower end opening part. The annular rib 92 of the cap-shaped partition 90 is housed in the annular recess 93 of the cylindrical member 4d, and both are engaged, and the partition 90 is not detached from the cylindrical member 4d. .

  Also in the soft medical container 1e of this embodiment, similarly to the soft medical container 1d described above, the cylindrical member enclosing part 8d is opened, the cap part 81 is detached, and the prefilled syringe is attached to the exposed injection needle hub 32. After the 10 is attached, the prefilled syringe 10 is pushed in the direction of the drug container body 2b, whereby the injection needle 3 penetrates the partition part 9 and communicates the inside of the injection needle 3 and the drug storage part 22 of the container body 2b. As a result, the medical liquid in the prefilled syringe 10 can be injected into the medicine container 22.

  The cap-shaped partition part 90 is formed of an elastic material that can be pierced by the injection needle 3. As the elastic material, a rubber material or an elastomer is preferable. Rubber materials include isoprene rubber, butyl rubber, isobutyl rubber, natural rubber, styrene-butadiene copolymer rubber, polybutadiene rubber, ethylene-propylene rubber, ethylene-propylene-diene terpolymer rubber, silicone rubber and fluorine rubber. Is mentioned. Examples of the elastomer include various thermoplastic elastomers such as an olefin elastomer and a styrene elastomer.

  Moreover, in the soft medical container having the above-described film or sheet type partitioning portion, the opening mechanism of the partitioning portion is not limited to that by the needle piercing as described above. For example, like the soft medical container 1f shown in FIGS. 16 and 17, the partition portion 9 may be opened by a slide tube slidably accommodated in the cylindrical member 4f.

  As shown in FIG. 16, the soft medical container 1f of this embodiment has a slide tube 18 housed in a cylindrical member 4f. The slide tube 18 has an elastic seal member 6a in close contact with the hollow needle of the injection needle 3 inside. The injection needle 3 is held by the slide tube 18 by the elastic seal member 6a. For this reason, the slide tube 18 moves in the direction of the partition portion by the movement of the injection needle 3. However, the cylindrical member 4f includes an inner rib 95 that can come into contact with the rear end of the slide tube 18, and regulates the detachment of the slide tube from the cylindrical member 4f. A partition breaker tip 96 is provided at the tip (lower end) of the slide tube 18.

  Also in the soft medical container 1f of this embodiment, the cylindrical member encapsulating portion 8d is opened, the cap portion 81 is detached, and the prefilled syringe 10 is attached to the exposed injection needle hub 32. By pushing in the container main body 2b direction, the slide tube 18 opens the partition part 9, and connects the inside of the injection needle 3 and the medicine storage part 22 of the container main body 2b. Thereby, the medical liquid in the prefilled syringe 10 can be injected into the medicine container 22.

DESCRIPTION OF SYMBOLS 1 Soft medicine container 2 with which medicine was stored Soft container main body 3 Injection needle 4 Cylindrical member 5 Drug 8 Cylindrical member encapsulation part 9 Partition part 10 Prefilled syringe 22 Drug storage part 23 Cylindrical member encapsulation part 33 Cutting edge 26 Partition part

Claims (15)

A soft medical container having a medicine container, comprising: a soft container body having a medicine container; a medicine stored in the medicine container; and a cylindrical member fixed to the container body;
The medicine container of the container body is capable of injecting medical liquid,
The medical container releases the injection needle housed in the tubular member so that it can be taken out and the cutting edge faces the medicine housing portion side, the inside of the cylindrical member, the inside of the injection needle, and the medicine housing portion A soft medical container containing a medicine, characterized in that it has a partition section that can be partitioned. The injection needle includes a hollow needle having the cutting edge at a tip thereof, and an injection needle hub fixed to a proximal end portion of the hollow needle, and the cylindrical member connects the injection needle to a rear end of the injection needle hub. The medical container in which medicine is stored according to claim 1, wherein the medical container is stored in a state where a syringe can be connected to the opening. The medical container according to claim 2, wherein the cylindrical member is provided with an elastic seal member that is in an annular and liquid-tight contact with the outer surface of the hollow needle and allows the hollow needle to slide. The said soft container main body is a thermoplastic soft container main body, The said partition part is formed of the weak seal part which can be peeled formed in the said soft container main body, The chemical | medical agent in any one of Claim 1 thru | or 3 Stored soft medical container. The soft medical container in which the medicine is stored according to claim 4, wherein the weak seal part is peeled off by the medical liquid flowing out from the injection needle. The medical container includes a small volume gap formed between the weak seal portion of the container body and the elastic seal member of the cylindrical member, and the volume of the small volume gap is 0.1 to 5 ml. 6. A soft medical container in which a medicine is stored according to claim 4 or 5. The soft medical container in which the medicine is stored according to any one of claims 4 to 6, wherein the weak seal portion has an easy peeling portion provided at a site in front of the cutting edge of the injection needle. 4. The soft medicine container in which the medicine is stored according to claim 1, wherein the partition part is formed by a sealing member provided at an end part of the cylindrical member on the medicine storage part side. The injection needle is accommodated in the cylindrical member so as to be movable in the direction of the medicine accommodating portion, and the sealing member is a film that can be pierced by the injection needle or opened by the injection needle. Alternatively, the drug-stored soft medical container according to claim 8 which is a sheet. The said injection needle is accommodated in the said cylindrical member so that a movement in the said medicine accommodating part direction is possible, and the said sealing member is an elastic member which the said injection needle can penetrate. A soft medical container containing the medicine. 11. The medical container according to claim 1, wherein the medical container includes a cylindrical member encapsulating portion that blocks communication between the inside of the cylindrical member and the inside of the injection needle and the outside and can be opened. A soft medical container containing the medicine. The drug-stored soft medical container according to claim 11, wherein the cylindrical member encapsulating part is a soft bag-like encapsulating part that is integrated with the container body or fixed to the container body. 12. The medicine container according to claim 11, wherein the cylindrical member-encapsulating portion is an openable cap member attached to the flexible container body or the cylindrical member so as to encapsulate an end portion of the cylindrical member. Finished soft medical container. 14. The medicine container according to claim 13, wherein the cap member includes a cylindrical fixing portion fixed to the container main body, a cap portion, and a fragile portion for breaking that connects the cylindrical fixing portion and the cap portion. Finished soft medical container. 15. A drug administration device comprising the soft medical container in which medicine is stored according to claim 1 and a prefilled syringe filled with the medical liquid.

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