Medicine container, medicine suction method, medicine discharge method, and gasket release tool

Abstract

The present invention comprises: a cylindrical container body for storing a medicine, said container body including a tip part in which a dispensing port for dispensing medicine stored inside the container body is formed, a base end part that is open in the axial direction; a gasket that is in close contact with the inner peripheral surface of the container body along the entire circumferential perimeter thereof when inserted into the opening of the base end part in the container body; and a release part that causes the gasket to move slightly. The release part includes: a mounting part that is mounted on the base end part of the container body; and a movable part that is configured so as to move while being guided by the mounting part and thereby cause the gasket to move slightly.

Description

Drug container, drug suction method, drug discharge method, and gasket release tool CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority from Japanese Patent Application No. 2023-121065, the entire disclosure of which is incorporated herein by reference.

[0002] The present invention relates to a drug container for storing a drug, a drug suction method, a drug discharge method, and a gasket release tool.

[0003] As one type of the drug container, for example, an ampoule as disclosed in Patent Document 1 is known.

[0004] This ampoule is roughly cylindrical. One end of the ampoule is closed by a stopper (sealing membrane). The other end of the ampoule is closed by a piston that can move inside the ampoule. The inside of the ampoule (specifically, the space between the stopper and the piston) contains an injection solution.

[0005] When using a syringe to inhale the injection liquid stored in the ampoule, the needle of the syringe is first inserted through the sealing membrane of the ampoule, which causes the needle to penetrate into the ampoule. Next, the piston rod of the syringe is pulled back, which causes the injection liquid in the ampoule to be drawn into the syringe.

[0006] At this time, when the injection liquid is drawn into the syringe, the piston in the ampoule moves toward the syringe, preventing gas from being generated inside the ampoule.

[0007] However, when the conventional ampoule piston adheres to the inner circumferential surface of the ampoule, it may become difficult to initiate its movement. In this case, the force required to start drawing the injection liquid from the ampoule into the syringe (i.e., the force required to start moving the piston inside the ampoule) becomes large, making it difficult to start moving the piston.

[0008] Japanese Patent Publication No. 9-164202

[0009] In view of the above, the present invention aims to provide a drug container that can easily start moving the gasket when the drug is dispensed, a drug suction method, a drug ejection method, and a gasket release tool.

[0010] The drug container of the present invention comprises a cylindrical container body for containing a drug, the container body having a tip end formed with an outlet for discharging the drug contained inside the container body to the outside, and a base end that opens in the axial direction; a gasket that, when inserted into the opening at the base end of the container body, is in close contact with the inner surface of the container body all around the circumference; and a release part that slightly moves the gasket, the release part having an attachment part that is attached to the base end of the container body, and a movable part that is configured to move while being guided by the attachment part to slightly move the gasket.

[0011] In the drug container of the present invention, the gasket may be configured to be separated from the movable part and to be movable toward the tip end of the container body.

[0012] In the drug container of the present invention, the gasket may have a rear surface facing the outside from the opening, and the movable part may be configured to abut against the rear surface of the gasket in an unbonded state and press against the rear surface, thereby slightly moving the gasket.

[0013] The drug container of the present invention comprises a cap having a sealing plug portion that closes the outlet, the container body having a body portion located between the tip end and the base end, the tip end having a flow passage through which the drug flows, the flow passage including the outlet and a communication port that continues into the space inside the body, the sealing plug portion having a press-fit portion that is press-fitted from the outlet into the flow passage, the press-fit portion being configured to reach from the outlet to the communication port while being press-fitted into the flow passage from the outlet.

[0014] In the drug container of the present invention, the tip portion of the container body has a shoulder portion connected to the tip of the body portion in the axial direction, and a cylindrical nozzle portion extending forward from the tip of the shoulder portion, the outlet is formed at the tip portion of the nozzle portion, the communication port is formed at the tip portion of the shoulder portion, the flow passage is formed across the nozzle portion and the shoulder portion, and the inner surface of the shoulder portion, the annular rear end surface of the press-fit portion that is arranged toward the inside of the body portion, and the front surface of the gasket may each be tapered surfaces at the same angle.

[0015] In the drug container of the present invention, when the gasket is moved to the most distal end side of the container body, the volume of the space surrounded by the inner circumferential surface of the nozzle, the sealing plug, and the front surface of the gasket is 15 to 150 mm ３ The configuration may be such that:

[0016] The drug container of the present invention comprises a cap having a sealing plug portion that closes the outlet, the container body having a body portion located between the tip end and the base end, the tip end having a flow path through which the drug flows, the flow path including the outlet and a communication port that continues into the space inside the body, the sealing plug portion having a press-fit portion that is press-fitted from the outlet into the flow path, the press-fit portion having an inner recess that opens toward the space inside the body, and the inner diameter of the inner recess may be configured to be 2.0 to 7.0 mm.

[0017] The method for aspirating a drug of the present invention is a method for aspirating a drug filled in the drug container using a syringe, and includes the steps of: slightly moving the gasket using the release part; puncturing the needle part attached to the syringe into the sealing stopper part that blocks the outlet; and aspirating the drug in the container body by pulling the plunger of the syringe.

[0018] The drug ejection method of the present invention is a drug ejection method for ejecting drug filled in any of the drug containers described above, and includes the steps of: slightly moving the gasket with the release part; and then pushing the rear surface of the gasket toward the tip end of the container body, thereby advancing the gasket toward the tip end of the container body and ejecting the drug in the container body.

[0019] The gasket release tool of the present invention comprises an attachment part that is attached to the open end of a cylindrical part into which a gasket is inserted so as to be in close contact with the inner peripheral surface around the entire circumference, and a movable part that is configured to move while being guided by the attachment part, thereby slightly moving the gasket.

[0020] FIG. 1 is a perspective view of a drug container according to one embodiment of the present invention. FIG. 2 is a longitudinal cross-sectional view of the drug container according to the same embodiment. FIG. 3A is an enlarged longitudinal cross-sectional view of the distal end side of the drug container according to the same embodiment. FIG. 3B is an enlarged longitudinal cross-sectional view of the distal end side of the container body. FIG. 4 is an enlarged longitudinal cross-sectional view of the proximal end side of the drug container according to the same embodiment, showing the state before the release unit slightly moves the gasket. FIG. 5 is an enlarged longitudinal cross-sectional view of the proximal end side of the drug container according to the same embodiment, showing the state after the release unit slightly moves the gasket. FIG. 6 is a cross-sectional view taken along line VI-VI in FIG. 4. FIG. 7 is an explanatory diagram of a method of using the drug container according to the same embodiment, showing the state in which the gasket has been slightly moved by the release unit. FIG. 8 is an explanatory diagram of a method of using the drug container according to the same embodiment (a method of aspirating a drug), showing the state in which the release unit has been returned to its initial state and the syringe needle has been inserted. FIG. 9 is an explanatory diagram of a method of using the drug container according to the same embodiment (a method of aspirating a drug), showing the state in which the liquid in the container body has been dispensed. FIG. 10 is an explanatory diagram of a method of using the drug container according to the embodiment (a method of ejecting a drug), showing a state in which an injection needle is inserted after the release unit has been returned to its initial state. FIG. 11 is an explanatory diagram of a method of using the drug container according to the embodiment (a method of ejecting a drug), showing a state in which liquid is being dispensed from the container body. FIG. 12 is a perspective view of a drug container according to another embodiment of the present invention. FIG. 13 is an enlarged longitudinal cross-sectional view of the base end side of the drug container according to the embodiment, showing a state before the release unit slightly moves the gasket. FIG. 14 is an enlarged longitudinal cross-sectional view of the base end side of the drug container according to the embodiment, showing a state after the release unit slightly moves the gasket. FIG. 15 is a perspective view of a drug container according to yet another embodiment of the present invention. FIG. 16 is an enlarged longitudinal cross-sectional view of the base end side of the drug container according to the embodiment. FIG. 17 is a cross-sectional view taken along line XVII-XVII in FIG. 16. FIG. 18 is a diagram of the drug container used in Example 2. FIG. 19 is a diagram of the seal stopper used in Example 2. Fig. 20A is an explanatory diagram of the dead space that occurs when a general seal plug is used, and Fig. 20B is an explanatory diagram of the dead space that occurs when the seal plug of the present invention is used.

[0021] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS A drug container according to one embodiment of the present invention will now be described with reference to the accompanying drawings. The drug container according to this embodiment is used to store a drug.

[0022] Furthermore, the drug container of this embodiment can be used in various situations. For example, the drug container can be used as a vial, which is often used during drug development and clinical trials because it allows for dosage adjustment. Furthermore, when the drug is released to the market, the drug container can be used not only as a vial but also as a prefilled syringe or cartridge, which are easy for users to handle.

[0023] Therefore, the drug container can be used both during drug development and when the drug is released to the market, thereby reducing the effort and cost required to switch between containers used during development and when the drug is released to the market.

[0024] As shown in Figure 1, the drug container 1 is a cylindrical container body 2 that contains a drug, and has a tip portion 20 at which an outlet is formed for injecting the drug contained inside the container body 2 to the outside, and a base portion 21 that opens in the axial direction, and as shown in Figure 2, a gasket 3 that, when inserted into the opening of the base portion 21 in the container body 2, makes tight contact with the inner surface of the container body 2 all around the circumference, a release portion 4 that slightly moves the gasket 3, and a cap 5 for closing the outlet at the tip portion 20.

[0025] In describing the drug container 1 of this embodiment, the direction in the axial direction of the container body 2 from the base end 21 to the tip end 20 is referred to as the forward direction, and the direction in the axial direction of the container body 2 from the tip end 20 to the base end 21 is referred to as the rearward direction.

[0026] Furthermore, a direction perpendicular to the axial direction is referred to as a radial direction, and a circumferential direction centered on the central axis of the container body 2 is referred to as a circumferential direction.

[0027] The container body 2 has the above-mentioned tip portion 20 , base portion 21 , and a cylindrical body portion 22 located between the tip portion 20 and base portion 21 .

[0028] As shown in FIG. 3A , the tip portion 20 has a shoulder portion 200 that extends forward from the tip of the body portion 22 in the axial direction and is formed so that the outer diameter and inner diameter decrease from the base end toward the tip, a cylindrical nozzle portion 201 that extends forward from the tip of the shoulder portion 200, and a return portion 202 that protrudes radially outward from the outer peripheral surface of the nozzle portion 201.

[0029] The shoulder portion 200 has an annular shape when viewed in the axial direction, and therefore has an inner hole formed at the center of the shoulder portion 200 that passes through in the axial direction.

[0030] As described above, the shoulder portion 200 extends forward from the tip of the body portion 22 and is formed so that the inner diameter decreases from the base end to the tip. Therefore, the inner surface F1 of the shoulder portion 200 is inclined so that the inner peripheral edge is located forward of the outer peripheral edge.

[0031] The nozzle portion 201 extends forward from the inner circumferential end of the shoulder portion 200. The outer diameter of the nozzle portion 201 is smaller than the outer diameter of the body portion 22.

[0032] The inner hole of the shoulder portion 200 is continuous with the space inside the nozzle portion 201 and the space inside the body portion 22. As a result, the tip portion 20 of this embodiment has a flow passage R through which the medicine flows, which includes an outlet R1 formed by an opening on the tip side of the nozzle portion 201 and a communication port R2 formed by the inner hole of the shoulder portion 200 (see FIG. 3B ).

[0033] The return portion 202 of this embodiment is formed so as to be continuous over the entire circumferential direction of the nozzle portion 201 .

[0034] As shown in FIG. 4 , the base end portion 21 has a cylindrical base end tubular portion 210 and a flange portion 211 that protrudes radially outward from the outer circumferential surface of the base end tubular portion 210 .

[0035] The inner diameter and outer diameter of the proximal end tubular portion 210 are constant or approximately constant over the entire length in the axial direction.

[0036] The inner diameter of the base end tubular portion 210 is the same as the inner diameter of the body portion 22 , and the outer diameter of the base end tubular portion 210 is the same as the outer diameter of the body portion 22 .

[0037] The internal space of the base end tubular portion 210 and the internal space of the body portion 22 are continuous with each other.

[0038] The inner diameter and outer diameter of the body portion 22 are constant or approximately constant over the entire length in the axial direction.

[0039] As described above, one end of the body portion 22 in the axial direction is continuous with the shoulder portion 200. The other end of the body portion 22 in the axial direction is continuous with the base end portion 21.

[0040] The inner surface F2 of the body 22 and the inner surface F3 of the base end 21 may be coated to facilitate sliding of the gasket 3. The coating on the inner surface F2 of the body 22 and the inner surface F3 of the base end 21 is performed by applying silicone oil to the inner surface F2 of the body 22 and the inner surface F3 of the base end 21, for example.

[0041] The gasket 3 has a cylindrical columnar portion 30, an annular portion 31 that protrudes radially outward from the outer peripheral surface of the columnar portion 30 and is formed so as to be continuous around the entire circumference, and a tapered portion 32 that protrudes from the tip of the columnar portion 30 (one end that is positioned toward the tip portion 20 of the container body 2).

[0042] In this embodiment, the cylindrical portion 30 has a recess 300 that opens at its base end surface (the end surface facing rearward). A female thread is formed on the inner circumferential surface of this recess. The base end surface of the cylindrical portion 30 is configured to face the outside through the opening, and serves as the rear surface of the gasket 3.

[0043] A plurality of annular portions 31 are formed on the cylindrical portion 30. The plurality of annular portions 31 are arranged at intervals from one another in the axial direction.

[0044] Each of the plurality of annular portions 31 is configured to come into close contact with the inner peripheral surface of the container body 2 (specifically, the inner peripheral surface of the base end portion 21 and the inner peripheral surface of the barrel portion 22) over the entire circumferential direction when the gasket 3 is inserted into the container body 2. Therefore, each of the plurality of annular portions 31 is configured to block the flow of fluid in the axial direction between the space in front of the gasket 3 inside the container body 2 and the space in back of the gasket 3 inside the container body 2.

[0045] Although the number of annular portions 31 in this embodiment is three, the number of annular portions 31 may be one or four or more as long as it is possible to block the flow of fluid in the axial direction between the space in front of the gasket 3 in the container body 2 and the space behind the gasket 3 in the container body 2.

[0046] The tapered portion 32 is formed in a conical shape. More specifically, the tapered portion 32 is formed so that the outer diameter of the base end connected to the cylindrical portion 30 is the same or approximately the same as the outer diameter of the cylindrical portion 30, and the outer diameter gradually decreases from the base end toward the tip. Therefore, the outer surface of the tapered portion 32 is inclined so that the center is located further forward than the outer peripheral end.

[0047] The release portion 4 has an attachment portion 40 that is attached to the base end portion 21 of the container body 2, and a movable portion 41 that is configured to move while being guided by the attachment portion 40, thereby slightly moving the gasket 3.

[0048] The mounting part 40 is formed in an annular shape. The mounting part 40 is configured so that it can be fixed to the base end part 21 of the container body 2 in a state where it is placed over the base end part 21 of the container body 2.

[0049] The mounting portion 40 of this embodiment has a fixed side cover portion 400 that is formed in an annular shape and covers the base end portion 21 of the container body 2, and a fixed side removal prevention portion 401 that prevents the fixed side cover portion 400 from being removed from the base end portion 21 of the container body 2.

[0050] The fixed side cover portion 400 has an inner peripheral cover portion 400a that covers the inner peripheral surface of the base end portion 21, an end face cover portion 400b that covers the end face of the base end portion 21, and an outer peripheral cover portion 400c that covers the outer peripheral surface of the base end portion 21.

[0051] The inner circumferential cover portion 400 a is formed in a cylindrical shape. The outer circumferential surface of the inner circumferential cover portion 400 a is disposed opposite to the inner circumferential surface of the base end portion 21 .

[0052] The end face cover portion 400b extends radially outward from the entire outer circumferential surface of the rear end portion (the rearmost of the pair of axial ends) of the inner circumferential cover portion 400a. Therefore, the end face cover portion 400b is formed in an annular shape.

[0053] The outer periphery cover portion 400c extends forward from the entire periphery of the outer periphery end portion of the end face cover portion 400b.

[0054] Therefore, in the fixed side cover part 400, a recess into which the base end part 21 of the container body 2 can be inserted is formed by the inner peripheral cover part 400a, the end face cover part 400b and the outer peripheral cover part 400c.

[0055] The mounting part 40 is restricted from rotating (rotating in the circumferential direction around the central axis of the container body 2) while attached to the base end part 21 of the container body 2. More specifically, the relative rotation between the fixed side cover part 400 and the base end part 21 of the container body 2 is restricted.

[0056] The rotation of the fixed side cover portion 400 relative to the base end portion 21 of the container body 2 may be restricted, for example, by the inner circumferential cover portion 400 a being press-fitted into the base end portion 21 of the container body 2 .

[0057] The fixed-side retaining portion 401 is configured by a claw portion that extends radially inward from the tip portion 20 of the outer peripheral cover portion 400c. This claw portion is configured to abut against the front surface (the surface facing forward) of the flange portion 211 when the base end portion 21 of the container body 2 is inserted into the recess of the fixed-side cover portion 400. Therefore, the fixed-side retaining portion 401 is configured so that the claw portion can hold the flange portion 211 of the base end portion 21.

[0058] The movable part 41 has a movable operating part 410 that is attached so as to move relative to the mounting part 40, a driven part 411 that moves in the axial direction in conjunction with the movement of the movable operating part 410, and an interlocking structure 412 that interlocks the movement of the movable operating part 410 with the movement of the driven part 411.

[0059] The movable operating part 410 has an inner movable part 410a arranged inside the inner cover part 400a, an end face movable part 410b abutting the outer surface of the end face cover part 400b, an outer movable part 410c covering the outer periphery of the outer cover part 400c, and a movable side removal prevention part 410d for preventing removal from the mounting part 40.

[0060] The inner movable portion 410a is formed in a cylindrical shape. The outer peripheral surface of the inner movable portion 410a is positioned radially inwardly away from the inner peripheral surface of the inner cover portion 400a. As a result, a gap is formed between the outer peripheral surface of the inner movable portion 410a and the inner peripheral surface of the inner cover portion 400a.

[0061] The end surface movable portion 410b extends radially outward from the entire outer periphery of the inner periphery movable portion 410a (specifically, the rearward end of the pair of axial ends of the inner periphery movable portion 410a). Therefore, the end surface movable portion 410b is formed in an annular shape.

[0062] The outer periphery movable portion 410c extends forward from the entire periphery of the outer periphery end portion of the end surface movable portion 410b.

[0063] Therefore, in the movable operating part 410, a recess capable of accommodating the mounting part 40 is formed by the inner circumferential movable part 410a, the end surface movable part 410b, and the outer circumferential movable part 410c.

[0064] The movable-side retaining portion 410d is configured by a claw portion extending radially inward from the tip of the outer circumferential movable portion 410c. This claw portion is configured to abut against the front surface (the surface facing forward) of the outer circumferential cover portion 400c of the mounting portion 40 when the mounting portion 40 is inserted into the recess of the movable operating portion 410. Therefore, the movable-side retaining portion 410d is configured so that the claw portion can hold the outer circumferential cover portion 400c of the mounting portion 40.

[0065] The driven part 411 is formed in a cylindrical shape and is disposed between the inner circumferential cover part 400a and the inner circumferential movable part 410a, and is allowed to move in the axial direction.

[0066] The interlocking structure 412 of this embodiment is composed of a male thread portion 412a formed on the outer peripheral surface of the inner movable portion 410a, a female thread portion 412b formed on the inner peripheral surface of the driven portion 411, and a rotation prevention portion 412c that regulates the rotation of the driven portion 411 in the circumferential direction.

[0067] In the movable portion 41, when the movable operating portion 410 rotates to one side in the circumferential direction, the female thread portion 412b also rotates to one side in the circumferential direction, and accordingly, the female thread portion 412b meshes with the male thread portion 412a, and the driven portion 411 is advanced forward.

[0068] When the driven part 411 is fed (moved) forward, the tip end surface thereof comes into contact with the gasket 3. Therefore, the driven part 411 is configured to move the gasket 3 slightly by pushing the rear surface of the gasket 3 forward (see FIG. 5).

[0069] The follower portion 411 is simply configured to abut against the rear surface of the gasket 3 in the axial direction. In other words, the follower portion 411 abuts against the rear surface of the gasket 3 in a non-bonded state.

[0070] When the movable operating part 410 rotates to the other side in the circumferential direction, the male threaded part 412a also rotates to the other side in the circumferential direction. Accordingly, the female threaded part 412b meshes with the male threaded part 412a, and the driven part 411 is moved rearward.

[0071] As described above, the mounting portion 40 is restricted from rotating relative to the base end portion 21 of the container body 2, so that even if the movable operating portion 410 is rotated to one side or the other in the circumferential direction, it will not rotate together with the movable operating portion 410.

[0072] As shown in Figure 6, the rotation prevention portion 412c has an inner fitting portion 412d formed on the outer peripheral surface of the driven portion 411, and an outer fitting portion 412e formed on the inner peripheral surface of the inner cover portion 400a and fitting into the inner fitting portion 412d.

[0073] The inner fitting portion 412d is configured as a recess formed so as to curve radially inward from the outer circumferential surface of the driven portion 411. The inner fitting portion 412d is also formed so as to extend along the axial direction.

[0074] The outer fitting portion 412e is configured by a protrusion that protrudes radially inward from the inner circumferential surface of the inner circumferential cover portion 400a, and extends along the axial direction.

[0075] The inner fitting portion 412d and the outer fitting portion 412e are engaged in the circumferential direction. Therefore, the driven portion 411 is prevented from rotating relative to the inner circumferential cover portion 400a (i.e., the rotation of the driven portion 411 in the circumferential direction is restricted). This prevents the driven portion 411 from rotating together with the inner circumferential movable portion 410a.

[0076] In the rotation prevention portion 412c of this embodiment, the inner fitting portion 412d is a recess and the outer fitting portion 412e is a protrusion, but the inner fitting portion 412d may be a protrusion and the outer fitting portion 412e may be a recess.

[0077] 3A, the cap 5 has a seal plug portion 50 that closes the pouring outlet of the nozzle portion 201, and a cap cover 51 that covers the seal plug portion 50. The cap 5 may be made of resin or metal as long as it is configured to cover the seal plug portion 50. The cap 5 may also be configured without the cap cover 51.

[0078] The seal plug 50 has a press-fit portion 500 that is press-fitted into the flow passage from the outlet of the nozzle portion 201 , and an abutment portion 501 that is continuous with the tip of the press-fit portion 500 and abuts against the tip of the nozzle portion 201 .

[0079] The press-fit portion 500 is formed in an axial shape. When the press-fit portion 500 is press-fitted into the spout of the nozzle portion 201, the outer peripheral surface of the press-fit portion 500 and the inner peripheral surface of the nozzle portion 201 are configured to be in close contact with each other over the entire circumferential direction.

[0080] An inner recess 500b that opens at a rear end surface 500a that faces rearward is formed in the press-fit portion 500. The position of the bottom of the inner recess 500b is set at a position shifted rearward from the contact position between the abutment portion 501 and the tip of the nozzle.

[0081] The rear end surface 500a of the press-fit portion 500 is formed to have an annular shape when viewed from the rear. The rear end surface 500a of the press-fit portion 500 is inclined so that the inner circumferential edge is positioned forwardly of the outer circumferential edge. The outer circumferential edge of the rear end surface 500a extends to a position approximately coincident with the inner circumferential edge of the inner surface F1 of the shoulder portion 200 in the axial direction.

[0082] Here, the press-fit portion 500 is configured to extend from the pouring outlet R1 to the communication port R2 in a state where it is press-fitted into the flow passage R from the pouring outlet R1 (see FIG. 3B).

[0083] As shown in FIG. 9 , the inner surface of the shoulder portion 200, the annular rear end surface of the press-fit portion 500 that is disposed toward the inside of the body portion 22, and the front surface of the gasket 3 (the outer surface of the tapered portion 32 of the gasket 3) are each configured with tapered surfaces of the same angle.

[0084] The inclination of the inner surface F1 of the shoulder portion 200 matches the inclination of the outer surface of the tapered portion 32 of the gasket 3. The inclination of the rear end surface 500a of the press-fit portion 500 also matches the inclination of the outer surface of the tapered portion 32 of the gasket 3. Therefore, when the gasket 3 moves most forward in the axial direction, the outer surface of the tapered portion 32 of the gasket 3 comes into close contact with the inner surface F1 of the shoulder portion 200 and the rear end surface 500a of the press-fit portion 500.

[0085] As shown in FIG. 3A , the center of the abutment portion 501 is located in front of the inner recess 500b. The center of the abutment portion 501 is a puncture portion 501a that is punctured by a needle attached to the nozzle of a syringe. The needle refers to an injection needle that is integrally formed with the nozzle of the syringe or a needle that is attached to an adapter that is detachable from the nozzle of the syringe. The needle may be made of metal or resin.

[0086] An outer recess 501b is formed in the center of the abutment portion 501, and is open on the front surface (the surface facing forward).

[0087] Outer recess 501b is formed in a position aligned with inner recess 500b in the axial direction, so that outer recess 501b is formed in front of inner recess 500b, thereby reducing the thickness of puncturing portion 501a.

[0088] The position of the bottom of the inner recess 500b is set rearward in the axial direction from the contact position between the abutting portion 501 and the tip of the tip portion 20. This reduces the depth of the inner recess 500b.

[0089] The cap cover 51 has a holding portion 510 that holds the sealing portion 50 that is pressed into the nozzle portion 201, and has a holding portion 510 in which a puncture opening 510a that opens the front of the puncture portion 501a is formed, and a sealing portion 511 that closes the puncture opening 510a of the holding portion 510.

[0090] The holding portion 510 has a cylindrical outer covering portion 510b that covers the periphery of the seal stopper portion 50 and the nozzle portion 201, a front covering portion 510c that is arranged in front of the seal stopper portion 50, and an inner hooking portion 510d that is formed on the outer covering portion 510b and can be hooked onto the return portion 202 from the rear direction.

[0091] The seal part 511 is attached to the front covering part 510c, and is detachable from the front covering part 510c.

[0092] When the seal part 511 is attached to the front covering part 510c, the puncturing opening 510a is closed by the seal part 511. When the seal part 511 is detached from the front covering part 510c, the puncturing opening 510a is opened.

[0093] The configuration of drug container 1 according to this embodiment is as described above. Next, as a method of using drug container 1, a method of dispensing the drug in drug container 1 will be described.

[0094] As methods for discharging the drug in drug container 1, a drug suction method for aspirating the drug in drug container 1 using a syringe and a drug ejection method for ejecting the drug in drug container 1 will be described.

[0095] As shown in Figure 2, the drug container 1 used in the drug inhalation method is stored with the drug filled in the container body 2, the opening at the base end 21 of the container body 2 closed by the gasket 3, and the outlet of the nozzle part 201 of the container body 2 closed by the seal stopper 50. The seal stopper 50 is fixed to the nozzle part 201 by a holding part 510 to which a seal part 511 is attached.

[0096] When extracting the medicine from the container body 2, the release part 4 is used to slightly move the gasket 3, the injection needle is inserted into the sealing part 50 (puncture part 501a), and the medicine in the container body 2 is extracted by suction.

[0097] More specifically, the method of aspirating a drug in this embodiment involves the operation of slightly moving the gasket 3 using the release part 4, the operation of returning the release part 4 to its original state after slightly moving the gasket 3 using the release part 4, the operation of removing the seal part 511 from the holding part 510, the operation of puncturing the above-mentioned stopper part 50 (puncture part 501a) with an injection needle, and the operation of extracting the drug from the container body 2 by suction.

[0098] In the operation of slightly moving the gasket 3 by the release part 4, the movable operation part 410 is moved relative to the mounting part 40, thereby moving the follower part 411 forward in the axial direction.

[0099] In this embodiment, the movable operating part 410 is rotated to one side in the circumferential direction, whereby the follower part 411 moves forward.

[0100] When the driven portion 411 comes into contact with the gasket 3, the gasket 3 is pushed forward by the driven portion 411 and moves slightly. At this time, if there is a portion of the gasket 3 that is adhered to the inner circumferential surface of the container body 2 (for example, the annular portion 31), the adhered portion is released from the adhered state to the inner circumferential surface of the container body 2 as the gasket 3 moves forward in the axial direction (see FIG. 7 ).

[0101] In the operation of returning the release portion 4 to its original state, the movable operating portion 410 is moved relative to the mounting portion 40, thereby moving the follower portion 411 rearward in the axial direction.

[0102] In this embodiment, the movable operating part 410 is rotated to the other side in the circumferential direction, whereby the driven part 411 moves rearward.

[0103] When the driven part 411 moves forward, the internal pressure of the container body 2 increases. Therefore, when the driven part 411 moves rearward, the gasket 3 moves rearward following the driven part 411.

[0104] Subsequently, the puncture opening 510a is opened when the seal portion 511 is removed from the holder 510. This opens the front of the puncture portion 501a, making it possible to insert an injection needle into the puncture portion 501a.

[0105] In the operation of puncturing the seal stopper 50 (puncture portion 501a) with a syringe needle, a normal disposable syringe needle can be used. Furthermore, a syringe needle that can provide an opening between the puncture portion 501a and the rear end surface 50a during puncture can be used. The opening at the tip end of the syringe needle may be open in the puncture direction or in a direction intersecting the puncture direction.

[0106] Then, an operation is performed to dispense the drug from the container body 2. For example, as shown in Fig. 8, when the drug from the container body 2 is transferred to the syringe S, the operation of dispensing the drug from the container body 2 involves inserting the injection needle N of the syringe S into the puncture portion 501a and pulling the plunger (not shown) of the syringe S, whereby the drug from the container body 2 is sucked into the syringe S.

[0107] Next, a method for ejecting a medicine will be described. The method for ejecting a medicine is used, for example, when transferring a medicine from the medicine container 1 to another container such as an infusion bag or a vial, or when administering a medicine from the medicine container 1 to a human body.

[0108] 2, the drug container 1 used in the drug ejection method is also stored with the drug filled in the container body 2, the opening at the base end 21 of the container body 2 closed by the gasket 3, and the outlet of the nozzle part 201 of the container body 2 closed by the seal stopper 50. The seal stopper 50 is fixed to the nozzle part 201 by a holding part 510 to which a seal part 511 is attached.

[0109] In the method of ejecting the medicine, when the medicine is to be extracted from the container body 2, the operation of slightly moving the gasket 3 using the release part 4, the operation of puncturing the sealing part 50 (puncture part 501a) with the injection needle, and the operation of extracting the medicine from the container body 2 are performed.

[0110] Then, the operation of slightly moving the gasket 3 using the release part 4, the operation of returning the release part 4 to its original state after slightly moving the gasket 3 using the release part 4, the operation of removing the sealing part 511 from the holding part 510 are performed, and the operation of puncturing the above-mentioned stopper part 50 (puncture part 501a) with an injection needle and the operation of ejecting the drug from the container body 2 are performed.

[0111] The method of operating the release part 4 is the same whether it is the drug ejection method or the drug inhalation method, so the operation of slightly moving the gasket 3 using the release part 4 in the drug ejection method and the operation of returning the release part 4 to its original state are the same as in the drug inhalation method.

[0112] Subsequently, the puncture opening 510a is opened when the seal portion 511 is removed from the holder 510. This opens the front of the puncture portion 501a, making it possible to insert an injection needle into the puncture portion 501a.

[0113] In the operation of puncturing the seal stopper 50 (puncturing portion 501a) with an injection needle in the drug ejection method, a double-ended needle A10 can be used as the injection needle (see FIG. 10), and one end of the double-ended needle A10 is punctured into the puncturing portion 501a. Note that FIG. 10 illustrates a double-ended needle unit A that includes the double-ended needle A10 and a detachable portion A11 that holds the double-ended needle A10 and is detachable from the holder 510.

[0114] The injection needle used in the drug ejection method is also configured so that an opening can be disposed between the puncturing portion 501a and the rear end surface 50a during puncturing. The opening at the tip side of the injection needle may be open in the puncturing direction or in a direction intersecting the puncturing direction.

[0115] Then, an operation is performed to dispense the medicine from the container body 2. More specifically, in the medicine ejection method of this embodiment, for example, a plunger P is attached to the recess 300 of the gasket 3, and the plunger P is pressed to move the gasket 3 forward, thereby ejecting the medicine from the container body 2 and transferring the entire amount of the medicine from the container body 2 to another container such as an infusion bag or a vial, or administering it to a human body (see FIG. 11 ).

[0116] In both the drug suction method and the drug ejection method, the gasket 3 moves forward as the drug in the container body 2 is discharged from the outlet, and when the drug contained in the container body 2 is completely discharged, the tapered portion 32 abuts against the inner surface of the shoulder portion 200 and the rear end surface 500a of the press-fit portion 500 (see Figure 9).

[0117] As described above, according to the drug container 1 of this embodiment, the release portion 4 can slightly move the gasket 3 that is in tight contact with the inner surface of the container body 2, so that even if the gasket 3 is adhered to the inner surface of the container body 2, the adherence between the gasket 3 and the inner surface of the container body 2 can be released, thereby achieving the excellent effect of making it easier for the gasket 3 to start moving when the drug is dispensed from the container body 2.

[0118] Furthermore, according to the method of aspirating a drug using the drug container 1, by slightly moving the gasket 3 that is in tight contact with the inner surface of the container body 2 using the release part 4, even if the gasket 3 is adhered to the inner surface of the container body 2, the adherence state between the gasket 3 and the inner surface of the container body 2 can be released, and then the needle of the syringe is inserted into the sealing part 50 and the plunger of the syringe is pulled to aspirate the drug inside the container body 2, so that the drug inside the container body 2 can be dispensed in a state in which the gasket 3 is likely to start moving.

[0119] Furthermore, in the method of ejecting medicine using the medicine container 1, even if the gasket 3 is stuck to the inner surface of the container body 2, it can be released from its stuck state by slightly moving the gasket 3, which is in tight contact with the inner surface of the container body 2, using the release part 4, and then by pushing the rear surface of the gasket 3 toward the tip of the container body 2, the gasket 3 is advanced toward the tip of the container body 2 to eject the medicine inside the container body 2, so that the medicine inside the container body 2 can be dispensed in a state where the gasket 3 is likely to start moving.

[0120] In this way, both the method of aspirating a drug using the drug container 1 and the method of ejecting a drug using the drug container 1 can have the excellent effect of making it easier for the gasket to start moving when the drug is dispensed.

[0121] Furthermore, in the drug container 1, the gasket 3 is configured to be able to move away from the movable part 41 and towards the tip 20 of the container body 2, so that when the drug in the container body 2 is dispensed, the gasket 3 can move without being restrained by the release part 4, allowing the drug in the container body 2 to be dispensed smoothly.

[0122] Furthermore, as in the drug container 1 of this embodiment, if the movable part 41 is configured to abut against the rear surface of the gasket 3 in an unattached state and press against the rear surface, thereby slightly moving the gasket 3, the gasket 3 after the slight movement can be made to move without being restrained by the release part 4, making it possible to easily and smoothly dispense the drug from the container body 2.

[0123] Furthermore, in the drug container 1 of this embodiment, the position of the bottom of the inner recess 500b in the sealing portion 50 is set at a position shifted rearward from the contact position between the abutment portion 501 and the tip of the nozzle, so that by reducing the depth of the inner recess 500b, the amount of drug remaining in the inner recess 500b can be reduced.

[0124] Furthermore, the sealing portion 50 has an outer recess 501b formed at a position aligned with the inner recess 500b in the axial direction. This not only reduces the depth of the inner recess 500b, but also reduces the amount of drug remaining in the inner recess 500b. By forming the outer recess 501b in front of the inner recess 500b, the thickness of the puncture portion 501a is reduced, so that the ease of puncturing the puncture portion 501a with an injection needle is not impaired.

[0125] Furthermore, the press-fit portion 500 of the sealing portion 50 is configured to extend from the pouring outlet to the communication port while being pressed into the flow passage from the pouring outlet, so that the volume within the flow passage is narrowed by the press-fit portion, thereby reducing the amount of drug (the so-called residual liquid amount) remaining in the flow passage after the drug inside the container body 2 has been poured out.

[0126] Furthermore, since the inner surface F1 of the shoulder portion 200, the annular rear end surface of the press-fit portion 500 that is positioned toward the inside of the body portion 22, and the front surface of the gasket 3 are all tapered at the same angle, when the gasket 3 moves to the tip end side inside the container body 2, the front surface of the gasket 3 abuts against the inner surface F1 of the shoulder portion 200 and the rear end surface of the press-fit portion 500.This makes it easier to prevent the drug from remaining between the front surface of the gasket 3 and the inner surface of the shoulder portion 200 and the rear end surface of the press-fit portion 500 when the drug inside the container body 2 is poured out.

[0127] When the gasket 3 is moved to the most distal end side of the container body 2, the volume of the space surrounded by the inner peripheral surface of the nozzle portion 201, the front surface of the gasket 3, and the seal plug portion 50 is 15 to 150 mm ３ In this way, it is easy to reduce the amount of residual medicine.

[0128] Furthermore, if the inner diameter of the inner recess 500b of the press-fit portion 500 of the cap 5 is 2.0 to 7.0 mm, it is possible to reduce residual liquid of the drug and to easily prevent the injection needle inserted into the seal stopper from coming into contact with the inside of the press-fit portion. Note that the inner diameter of the inner recess 500b of the press-fit portion 500 is preferably 2.0 to 5.0 mm.

[0129] In addition, the drug container 1 of this embodiment is configured so that when the injection needle N of the syringe S is inserted into the puncture portion 501a and then the plunger (not shown) of the syringe S is pulled, the gasket 3 moves forward due to the suction force of the syringe S. Therefore, for example, the drug inside the container body 2 can be sucked out with a simple operation without the need for an operation such as sending air into the inside of the container body 2.

[0130] This prevents the drug container 1 from falling into a situation where it is difficult to dispense the drug inside the container body 2, so that the amount of residual liquid can be reduced without the operator having to use their own technique (an operation to transfer residual liquid to the syringe S when residual liquid occurs), and also reduces the variation in the amount of residual liquid.

[0131] Furthermore, the gasket 3 advances while wiping the medicine off the inner surface F2 of the body of the medicine container 1, thereby preventing the medicine from remaining on the inner surface F2 of the body, thereby reducing the amount of residual liquid and also reducing the variation in the amount of residual liquid.

[0132] The drug container according to the present invention is not limited to the above-described embodiment, and various modifications can be made without departing from the spirit of the present invention.

[0133] Although the release unit 4 in the above embodiment is configured to slightly move the gasket 3 by rotating the movable unit 41 in the circumferential direction, the present invention is not limited to this configuration. For example, the release unit 4 may be configured to slightly move the gasket 3 by moving the movable unit 41 in the axial direction.

[0134] In this case, the movable part 41 may be configured to have, for example, a movable operating part 413 that is attached so as to move in the axial direction relative to the mounting part 40, and a follower part 414 that moves in the axial direction in conjunction with the movement of the movable operating part 413, as shown in Figures 12 to 14.

[0135] In this case, the movable operating portion 413 is formed in an annular shape and is disposed opposite the outer surface of the end surface cover portion 400b in the axial direction.

[0136] The driven part 414 is formed in a cylindrical shape and extends forward from the inner peripheral end of the movable operating part 413, and is inserted into the inner peripheral cover part 400a in a state where it can move in the axial direction.

[0137] Therefore, when the movable operating part 413 of the drug container 1 is pushed forward, the driven part 414 is moved forward, thereby slightly moving the gasket 3 forward; when the pushing operation on the movable operating part 413 is released, the driven part 414 is pushed back against the gasket 3 which is moving backward due to the internal pressure of the container body 2, so that the gasket 3 returns to its original position and the release part 4 returns to its original state.

[0138] If the gasket 3 does not return to its original position even when the pushing operation on the movable operation part 413 is released, it is also possible to grasp the movable operation part 413 and pull it.

[0139] Furthermore, the movable part 41 configured as described above preferably has a retaining structure 415 that retains the driven part 414 from the inner circumferential cover part 400a. The retaining structure 415 may have, for example, an outer convex part 415a that protrudes radially inward from the inner circumferential surface of the inner circumferential cover part 400a, and an inner convex part 415b that protrudes radially outward from the outer circumferential surface of the driven part 414, and the inner convex part 415b may be configured to engage with the outer convex part 415a from the front side.

[0140] Although the movable part 41 in the above embodiment is configured to release the adhered state between the gasket 3 and the container body 2 by slightly moving the gasket 3 in the axial direction, the present invention is not limited to this configuration. For example, the movable part 41 may be configured to release the adhered state between the gasket 3 and the container body 2 by rotating and slightly moving the gasket 3 in the circumferential direction.

[0141] In this case, the movable part 41 has a movable operating part 416 that is attached to the mounting part 40 so as to rotate circumferentially, and a follower part 417 that rotates circumferentially together with the movable operating part 416, as shown in Figures 15 to 17, for example.

[0142] The driven portion 417 extends forward from the movable operating portion 416. The tip of the driven portion 417 is configured to engage with the recess 300 in the circumferential direction when inserted into the recess 300 of the gasket 3.

[0143] Therefore, when the movable part 41 having the above configuration rotates the mounting part 40 in the circumferential direction, the driven part 417 and the gasket 3 rotate (slightly move) together with the mounting part 40, and the adhesion between the gasket 3 and the inner surface of the container body 2 is released.

[0144] In addition, since the engaging portion 300a formed in the recess 300 of the gasket 3 and the engaging portion 417a at the tip of the driven portion 417 extend along the axial direction, the gasket 3 and the driven portion 417 are capable of relative movement in the axial direction (see Figure 17).

[0145] Although the recessed portion 300 is formed in the gasket 3 in the above embodiment, the present invention is not limited to this configuration. For example, the gasket 3 may not have the recessed portion 300 formed therein.

[0146] In the above embodiment, the movable part 41 is configured to release the adhered state between the gasket 3 and the container body 2 by slightly moving the gasket 3 forward in the axial direction, but the movable part 41 may also be configured to release the adhered state between the gasket 3 and the container body 2 by slightly moving the gasket 3 backward in the axial direction.

[0147] Although the release part 4 in the above embodiment is a part that constitutes the drug container 1, the present invention is not limited to this configuration. For example, only the release part 4 may be a release tool for a gasket.

[0148] This gasket release tool may be configured to include, for example, an attachment part that is attached to the open end of the cylindrical part into which the gasket is inserted so as to be in close contact with the inner surface all around the circumference, and a movable part that is configured to move while being guided by the attachment part, thereby slightly moving the gasket.

[0149] Such a gasket release tool allows the gasket, which is in close contact with the inner surface of the cylindrical portion, to be slightly moved. Therefore, even if the gasket is stuck to the inner surface of the cylindrical portion, the gasket can be made to move more easily by releasing the stuck state between the gasket and the inner surface of the cylindrical portion.

[0150] Furthermore, if the cylindrical portion of the release tool contains the drug, like the base end of the container body 2 in the above embodiment, and has a gasket 3 inserted therein, the release tool can be used to slightly move the gasket 3, which is in close contact with the inner surface of the container body 2.Therefore, even if the gasket 3 is adhered to the inner surface of the container body 2, the adherence between the gasket 3 and the inner surface of the container body 2 can be released, making it possible to make the gasket 3 more likely to start moving when the drug in the container body 2 is dispensed.

[0151] The press-fit portion 500 in the above embodiment is formed so that its overall length in the axial direction is the same as the overall length of the flow path R (total length in the axial direction), and is configured so that it extends from the pouring outlet R1 to the communication port R2 when it is press-fitted from the pouring outlet R1 into the flow path R, but is not limited to this configuration. The press-fit portion 500 is formed so that its overall length in the axial direction is the same as the overall length of the flow path R (total length in the axial direction), but is not limited to this configuration. For example, the overall length of the press-fit portion 500 may be shorter than the overall length of the flow path R.

[0152] In this way, an area that is not reached by the press-fit portion 500 is formed on the communication port R2 side of the flow path R of the press-fit portion 500, so that it is possible to visually confirm when the needle tip of the injection needle that has punctured the press-fit portion 500 reaches this area. Therefore, it is possible to easily confirm the position of the needle tip of the injection needle that has punctured the press-fit portion 500.

[0153] It is preferable that the total length of the flow passage R is set to 5.0 mm to 11.0 mm and the total length of the press-fit portion 500 is set to 2.0 mm to 9.0 mm, and it is even more preferable that the flow passage R is formed so that its inner diameter is 2.0 mm to 13.00 mm.

[0154] (Evaluation of the amount of residual liquid in the vial when collecting the liquid) The total weight of the glass vial (a glass vial with a nominal capacity of 20 mL) and the rubber stopper for the vial was measured and taken as the tare weight (a) [g].

[0155] Buffer solution (buffering agent: 20 mmol / L histidine, stabilizer: 150 mmol / L arginine and 162 mmol / L aspartic acid, surfactant: 0.20 mg / mL poloxamer 188, pH 6.0, density 1.190 g / cm ３ ) was filled into the glass vial in an amount of 12 mL. The weight of the glass vial after filling and stoppering was measured, and the total weight (b) [g] was calculated by adding the tare weight and the filled weight.

[0156] A needle (Terumo syringe needle 18G; Terumo Corporation) was attached to a disposable syringe (Terumo syringe (registered trademark) 20 mL standard; Terumo Corporation), and the weight was measured to obtain the tare weight (c) [g] of the disposable syringe. Air was charged into the disposable syringe and inserted into the rubber stopper of a glass vial. The air in the syringe was then injected into the vial, and the liquid inside was aspirated in exchange for the air. Additionally, a disposable syringe with an attached needle but no air was inserted was inserted into the rubber stopper of a glass vial, and the liquid inside was aspirated.

[0157] The weight of the disposable syringe after the liquid was dispensed was measured, and the tare weight of the disposable syringe and the dispensed weight were added together to obtain the total weight (d) [g] of the disposable syringe. The filled weight was taken as (ba) [g], and the dispensed weight as (d-c) [g]. The residual liquid volume was calculated by subtracting the dispensed weight from the filled weight and dividing by the density value.

[0158] [Evaluation Results] The calculation results for the residual volume are shown in Table 1. As a result, it was found that when 12 mL of buffer solution was filled into a 20 mL glass vial and the solution was collected using a disposable syringe equipped with an 18 G needle, the average residual volume was 0.1534 mL (= 153.4 μL).

[0159]

[0160] (Calculation of the amount of residual liquid in this drug container when collecting liquid) Based on the drawing information of the container body with a nominal capacity of 20 mL, a general sealing part, and the sealing part of the present invention which adopts a structure to reduce the amount of residual liquid, the volume of the dead space generated in the container body was calculated as the expected amount of residual liquid.

[0161] A drawing of the drug container 1 used in the calculation is shown in Figure 18, and a drawing of the sealant part 50 of the present invention is shown in Figure 19. Note that the drawing of the drug container 1 does not include the release part 4.

[0162] The nozzle 201 of the drug container 1 has the same internal shape as a 2R vial. As shown in Figures 20A and 20B, the volume V1 of the area surrounded by the seal 50, the container body 2, and the gasket 3 was calculated using the volume calculation function of the CAD system and used as the residual liquid volume. The 2R vial is a vial with a nominal capacity of 2 ml in accordance with the ISO 08362-1 standard (see page 4).

[0163] [Evaluation Results] In reality, it is necessary to take into account the volume of the syringe needle and the reduction in the amount of residual liquid due to suction, so it is estimated that the amount of residual liquid will be even less than the calculated value of the dead space volume of the container on the drawing.

[0164] When a general sealant 6 is used instead of the sealant 50 of the drug container 1 shown in FIG. 18, the volume of the dead space (the volume of the area indicated by V1 in FIG. 20A) is 219 mm ３(219 μL), and the volume of the dead space (volume of the region indicated by V2 in FIG. 20B) of drug container 1 in FIG. 18 (drug container 1 equipped with seal stopper 50 in FIG. 19) is 41 mm ３ The volume of the liquid was 41 μL. The general sealant 6 is a rubber stopper for a 2R vial, the dimensions of which comply with the ISO 08362-2 standard.

[0165] When the sealant portion 50 in Figure 19 is attached to the container body 2, it is expected that the amount of residual liquid will be reduced by at least 70% compared to the amount of residual liquid of 153.4 μL that would be obtained if a 20 mL glass vial were filled with 12 mL of buffer solution and an 18 G needle were attached to a disposable syringe to collect the liquid.

[0166] The present disclosure includes the following contents.

[0167] (1) A drug container comprising: a cylindrical container body for containing a drug, the container body having a tip end formed with an outlet for discharging the drug contained inside the container body to the outside, and a base end opening in the axial direction; a gasket that is inserted into the opening at the base end of the container body and makes tight contact with the inner surface of the container body all around the circumference; and a release part that slightly moves the gasket, the release part having: an attachment part that is attached to the base end of the container body; and a movable part that is configured to move while being guided by the attachment part to slightly move the gasket.

[0168] The drug container of (1) above can slightly move the gasket that is in tight contact with the inner surface of the container body using the release part, so even if the gasket is stuck to the inner surface of the container body, by releasing the stuck state between the gasket and the inner surface of the container body, the gasket is more likely to start moving when the drug in the container body is poured out.

[0169] (2) A drug container, wherein the gasket is separated from the movable part and configured to be movable toward the tip end of the container body.

[0170] In the drug container of (2) above, the gasket can move without being restricted by the release portion when the drug in the container body is dispensed, so that the drug in the container body can be dispensed smoothly.

[0171] (3) The drug container may be configured such that the gasket has a rear surface facing the outside through the opening, and the movable part is configured to abut against the rear surface of the gasket in an uncoupled state and press the rear surface to slightly move the gasket.

[0172] The drug container of (3) can be made to move without being restricted by the release part after slight movement, so that the drug inside the container body can be easily and smoothly dispensed.

[0173] (4) A drug container in which the container body has a body portion located between the tip end and the base end, the tip end having a flow passage through which the drug flows, the flow passage including the pouring outlet and a communication port continuous with the space inside the body portion, the sealing plug portion having a press-fit portion that is press-fitted from the pouring outlet into the inside of the flow passage, and the press-fit portion is configured to reach from the pouring outlet to the communication port while being press-fitted from the pouring outlet into the flow passage.

[0174] In the drug container (4) above, the volume of the flow passage is narrowed by the press-fit portion, so that the amount of drug (i.e., the amount of residual liquid) remaining in the flow passage after the drug in the container body is dispensed can be reduced.

[0175] (5) A drug container in which the tip portion has a shoulder portion connected to the tip of the body portion in the axial direction and a cylindrical nozzle portion extending forward from the tip of the shoulder portion, the outlet is formed at the tip of the nozzle portion, the communication port is formed at the tip of the shoulder portion, the flow passage is formed across the nozzle portion and the shoulder portion, and the inner surface of the shoulder portion, the annular rear end surface of the press-fit portion that is arranged toward the inside of the body portion, and the front surface of the gasket are all tapered at the same angle.

[0176] In the drug container of (5) above, when the gasket moves to the most tip end of the container body, the front surface of the gasket abuts against the inner surface of the shoulder and the rear end surface of the press-fit portion, which makes it easier to prevent drug from remaining between the front surface of the gasket and the inner surface of the shoulder and the rear end surface of the press-fit portion when the drug in the container body is poured out.

[0177] (6) When the gasket is moved to the most distal end side of the container body, the volume of the space surrounded by the inner peripheral surface of the nozzle, the sealing plug, and the front surface of the gasket is 15 to 150 mm ３ The drug container is configured to be.

[0178] As in the drug container of (6), the volume of the space is 15 to 150 mm ３ If the container is configured so that the amount of residual medicine is reduced, the amount of residual medicine can be reduced.

[0179] (7) A drug container in which the container body has a body portion located between the tip portion and the base portion, the tip portion is formed with a flow passage through which the drug flows, the flow passage including the pouring outlet and a communication port continuing into the space inside the body portion, the sealant portion has a press-fit portion that is press-fitted from the pouring outlet into the inside of the flow passage, the press-fit portion is formed with an inner recess that opens toward the space inside the body portion, and the inner diameter of the inner recess is configured to be 2.0 to 7.0 mm.

[0180] If the inner diameter of the inner recess of the sealant portion is 2.0 to 7.0 mm, as in the drug container (7) above, it is possible to reduce residual drug liquid while making it easier to prevent the injection needle inserted into the sealant portion from coming into contact with the inside of the press-fit portion.

[0181] (8) A method for aspirating a drug filled in the drug container described in (1) above using a syringe, the method comprising: performing an operation of slightly moving the gasket using the release unit; puncturing the seal stopper with a needle portion attached to the syringe; and aspirating the drug in the container body by pulling the plunger of the syringe.

[0182] The method of aspirating the drug in (8) above involves slightly moving the gasket, which is in tight contact with the inner surface of the container body, using the release part to release the gasket from its adhered state to the inner surface of the container body, even if the gasket is adhered to the inner surface of the container body. This then involves inserting the syringe needle into the sealing part and pulling the syringe plunger to aspirate the drug from within the container body, making it possible to dispense the drug from within the container body in a state where the gasket is likely to start moving.

[0183] (9) A method for discharging a drug filled in the drug container of (1), comprising: performing an operation to slightly move the gasket using the release part; and then pressing the rear surface of the gasket toward the tip end of the container body, thereby advancing the gasket toward the tip end of the container body and discharging the drug in the container body.

[0184] The method of ejecting the medicine in (9) above involves slightly moving the gasket, which is in tight contact with the inner surface of the container body, using the release part to release the adhesion between the gasket and the inner surface of the container body, even if the gasket is stuck to the inner surface of the container body.The rear surface of the gasket is then pushed towards the tip of the container body, causing the gasket to move forward towards the tip of the container body and ejecting the medicine from the container body, so that the medicine in the container body can be dispensed in a state where the gasket is likely to start moving.

[0185] (10) A gasket release tool comprising: an attachment part attached to the open end of a cylindrical part into which a gasket is inserted so as to be in close contact with the inner peripheral surface around the entire circumference; and a movable part configured to move while being guided by the attachment part, thereby slightly moving the gasket.

[0186] The gasket release tool (10) can slightly move the gasket that is in close contact with the inner peripheral surface of the cylindrical portion, so even if the gasket is stuck to the inner peripheral surface of the cylindrical portion, it can release the stuck state between the gasket and the inner peripheral surface of the cylindrical portion, making it easier for the gasket to start moving.

[0187] 1...medicine container, 2...container body, 3...gasket, 4...release portion, 5...cap, 20...tip portion, 21...base end portion, 22...body portion, 30...cylindrical portion, 31...annular portion, 32...tapered portion, 40...attachment portion, 41...movable portion, 50...sealing portion, 51...cap cover, 200...shoulder portion, 201...nozzle portion, 202...turned portion, 210...base end tubular portion, 211...flange portion, 300...recess, 300a...engaging portion, 400...fixed side cover portion, 400a...inner circumferential cover portion, 400b...end surface cover portion, 400c...outer circumferential cover portion, 401...fixed side retaining portion, 410...movable operating portion, 410a...inner circumferential movable portion, 410b...end surface movable portion, 410c...outer circumferential movable portion, 410 d... Movable side retaining portion, 411... Follower portion, 412... Interlocking structure, 412a... Threaded portion, 412b... Threaded portion, 412c... Anti-rotation portion, 412d... Inner fitting portion, 412e... Outer fitting portion, 413... Movable operation portion, 414... Follower portion, 416... Movable operation portion, 417... Follower portion, 417a... Engagement portion, 500... Press-fit portion, 500a... Rear end surface, 500b... Inner recess, 501...Abutment portion, 501a...Puncture portion, 501b...External recess, 510...Retaining portion, 510a...Puncture opening, 510b...Outer peripheral covering portion, 510c...Front covering portion, 510d...Inner latch portion, 511...Sealing portion, S...Syringe, F1...Inner surface of shoulder portion, F2...Inner surface of body portion, F3...Inner surface of base end portion, N...Injection needle, R...Flow passage, R1...Outlet, R2...Communication port

Claims

1. A drug container comprising: a cylindrical container body for containing a drug, the container body having a tip end at which an outlet is formed for injecting the drug contained within the container body to the outside, and a base end that opens in the axial direction; a gasket that is in close contact with the inner surface of the container body all around the circumference when inserted into the opening of the base end of the container body; and a release portion that slightly moves the gasket, the release portion having an attachment portion that is attached to the base end of the container body, and a movable portion configured to move while being guided by the attachment portion to slightly move the gasket.

2. The drug container according to claim 1, wherein the gasket is separated from the movable part and configured to be movable toward the tip end of the container body.

3. A drug container as described in claim 1 or 2, wherein the gasket has a rear surface facing the outside from the opening, and the movable part is configured to slightly move the gasket by abutting against the rear surface of the gasket in an unbonded state and pressing against the rear surface.

4. A drug container as described in claim 1 or claim 2, comprising a cap having a sealing portion that closes the pouring outlet, the container body having a body portion located between the tip end and the base end, the tip end having a flow passage through which the drug flows, the flow passage including the pouring outlet and a communication port continuing into the internal space of the body, the sealing portion having a press-fit portion that is press-fitted from the pouring outlet into the inside of the flow passage, and the press-fit portion is configured to reach from the pouring outlet to the communication port while being press-fitted into the flow passage from the pouring outlet.

5. A drug container as described in claim 4, wherein the tip portion of the container body has a shoulder portion connected to the tip of the body portion in the axial direction and a cylindrical nozzle portion extending forward from the tip of the shoulder portion, the spout is formed in the tip portion of the nozzle portion, the communication port is formed in the tip portion of the shoulder portion, the flow passage is formed across the nozzle portion and the shoulder portion, and the inner surface of the shoulder portion, the annular rear end surface of the press-fit portion arranged toward the inside of the body portion, and the front surface of the gasket are all tapered at the same angle.

6. When the gasket is moved to the most distal end side of the container body, the volume of the space surrounded by the inner circumferential surface of the nozzle of the container body, the sealing plug, and the front surface of the gasket is 15 to 150 mm ３ The drug container according to claim 4 , 7. A drug container as claimed in claim 1 or claim 2, comprising a cap having a sealing part that closes the pouring outlet, wherein the container body has a body located between the tip and base ends, wherein the tip has a flow passage through which the drug flows, the flow passage including the pouring outlet and a communication port continuing into the space inside the body, wherein the sealing part has a press-fit part that is press-fitted from the pouring outlet into the inside of the flow passage, wherein the press-fit part has an inner recess that opens into the space inside the body, and wherein the inner diameter of the inner recess is 2.0 to 7.0 mm.

8. A method for aspirating a drug filled in a drug container as described in claim 1 using a syringe, comprising the steps of: slightly moving the gasket using the release unit; puncturing a needle portion attached to the syringe into a sealing plug portion blocking the outlet; and aspirating the drug within the container body by pulling the plunger of the syringe.

9. A method for discharging a drug filled in a drug container as described in claim 1, comprising the steps of: slightly moving the gasket with the release part; and then pushing the rear surface of the gasket towards the tip end of the container body, thereby advancing the gasket towards the tip end of the container body and discharging the drug within the container body.

10. A gasket release tool comprising: an attachment part that is attached to the open end of a cylindrical part into which a gasket is inserted so as to be in close contact with the entire circumferential surface; and a movable part that is configured to move while being guided by the attachment part, thereby slightly moving the gasket.

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