WO2013047042A1

WO2013047042A1 - Syringe

Info

Publication number: WO2013047042A1
Application number: PCT/JP2012/071452
Authority: WO
Inventors: 等沖原
Original assignee: テルモ株式会社
Priority date: 2011-09-26
Filing date: 2012-08-24
Publication date: 2013-04-04

Abstract

A pre-filled syringe (1) is provided with an outer tube (2) and a cap (5) attached to the opening (20) of the outer tube (2). The cap (5) is provided with a cap main body (50) having an inner cover (51) secured to the outside of the outer tube on the tip end side, an outer cover (52) arranged on the outside of the inner cover (51) and disposed so as to be able to move in the lengthwise direction, and a nozzle cap (53) arranged inside the inner cover (51) and disposed so as to be able to rotate about an axis. The cap main body (50) can move from a first position in which the nozzle cap (53) remains sealed to a second position in which the nozzle cap (53) retreats from the opening (20). The cap (5) has a return prevention means for preventing the cap main body (50) from returning to the first position from the second position when the cap main body (50) is positioned at the second position.

Description

Syringe

The present invention relates to a syringe.

A prefilled syringe in which a liquid preparation is aseptically filled in a sterilized syringe outer cylinder is known (for example, see Patent Document 1). This prefilled syringe has a syringe outer cylinder having a mouth part from which a liquid preparation is discharged and a lock adapter rotatably supported by the mouth part, and a cap that is attached to the mouth part of the syringe outer cylinder and is fixed by a lock member And. In the prefilled syringe described in Patent Document 1, in the unused state, that is, in the unopened state, the cap and the lock adapter are collectively covered with a film having a perforation in a mounted state in which the cap is mounted on the syringe outer cylinder. Has been.

And when this unused pre-filled syringe is opened, the cap is removed, and the cap is attached again without using the pre-filled syringe. I don't know what it is. In the prefilled syringe, once the cap is opened, it is difficult to maintain the internal sterility for a long period of time. However, if it is recapped as described above, there is a problem that the refilled prefilled syringe with low sterility is used while misidentifying that it is unused.

Therefore, in order to solve such problems, after opening an unused prefilled syringe and removing the cap, it is not possible to recap even if an attempt is made to recap, and to confirm that it has been opened. A prefilled syringe that can be used has been proposed (see, for example, Patent Document 2).

In this prefilled syringe, a cap cover that is attached to the tip of the syringe outer cylinder, and a nozzle cap that is accommodated in the cap cover so as to be movable in the longitudinal direction of the syringe outer cylinder and attached to the mouth of the syringe outer cylinder. A configured cap is used. When this cap is recapted, the cap cover is attached to the tip of the syringe barrel, but the nozzle cap is not attached to the mouth, thereby confirming that the prefilled syringe has been opened. Can be done.

However, in the conventional prefilled syringe, the nozzle cap is movably accommodated in the cap cover, so that during storage, the nozzle cap attached to the mouth moves and is detached from the mouth. Therefore, there is a problem that the sealed state of the mouth portion is released.

JP 2002-315827 A JP 2009-22641 A

An object of the present invention is to provide a syringe that can be used as a prefilled syringe that is excellent in tamper-proof property and that can maintain a sealed state in which a mouth is sealed before use.

Such an object is achieved by the present inventions (1) to (11) below.
(1) A syringe including a syringe outer cylinder having a cylindrical shape filled with a liquid and having a distal end portion including a mouth portion through which the liquid passes, and a cap attached to the mouth portion. And
The cap has a substantially cylindrical inner cover fixed to the outer side of the distal end portion of the syringe outer cylinder so that its axis is parallel to the axis of the syringe outer cylinder;
An outer cover disposed on the outer side of the inner cover and movable with respect to the inner cover in a longitudinal direction of the inner cover; and disposed on the inner side of the inner cover, together with the outer cover and the inner cover. And a cap body having a nozzle cap provided so as to be movable in the longitudinal direction of the inner cover,
The cap body is configured such that the nozzle cap moves the outer cover in a distal direction from a first position where the nozzle cap seals the mouth portion in a liquid-tight manner and maintains the sealed state. Moveable to a second position retracting from the mouth,
The cap has a return preventing means for preventing the cap body from returning from the second position to the first position when the cap body is located at the second position;
When the cap main body is positioned at the second position, at least a part of the inner cover can be separated from the distal end portion of the syringe outer cylinder together with the cap main body.

(2) The return prevention means includes a concave portion provided in one of the inner cover and the outer cover, and a convex portion provided in the other and engaged with the concave portion,
The syringe according to (1), wherein the concave portion and the convex portion are engaged when the cap main body is located at the second position.

(3) The concave portion is provided on an outer peripheral surface of the inner cover,
The said convex part is a syringe as described in said (2) provided in the internal peripheral surface of the said outer side cover.

(4) A first groove that guides the convex portion when the cap body moves from the first position to the second position is provided along an outer peripheral surface of the inner cover along a longitudinal direction of the inner cover. Provided,
The syringe according to (3), wherein the concave portion is disposed on a distal end side of the first groove.

(5) The syringe according to (4), wherein the first groove has an inclined surface in which the depth of the groove decreases toward the tip at the bottom surface.

(6) A second groove communicating with the proximal end side of the first groove is provided on the outer surface of the inner cover from the distal end of the inner cover to the proximal end of the first groove, and the convex portion is The syringe according to (4) or (5), wherein the syringe is guided from the distal end of the inner cover to the proximal end of the first groove by the second groove.

(7) A protrusion that allows the convex portion to move from the second groove to the first groove and prevents the convex portion from moving from the first groove to the second groove. The syringe according to (6), which is provided between the first groove and the second groove.

(8) The inner cover has an easily breakable portion that can be broken so that the inner cover is separated into a distal end portion and a proximal end portion on the proximal end side with respect to the distal end of the mouth portion,
(1) The tip of the inner cover is separated from the tip of the syringe outer cylinder together with the cap body by breaking the easily breakable portion when the cap body is located at the second position. Thru | or the syringe in any one of (7).

(9) When the cap body is located at the first position, the easily breakable portion is covered by the outer cover, and when the cap body is located at the second position, the cap body is The syringe according to the above (8), which is located on the tip side from the easily breakable portion.

(10) The outer cover has a first protrusion provided on an inner peripheral surface thereof,
The proximal end portion of the inner cover has a pair of second protrusions extending along the longitudinal direction of the inner cover on the outer surface thereof,
When the cap main body is positioned at the first position, the first protrusion and the second protrusion engage with each other, so that the cap main body moves around the axis of the inner cover with respect to the inner cover. The syringe according to any one of (1) to (9), wherein rotation is prevented and the engagement is released when the cap body is located at the second position.

(11) The syringe according to any one of (1) to (10), wherein the syringe is a prefilled syringe in which a liquid is filled in the syringe outer cylinder.

According to the present invention, since the return prevention means is provided, after the cap body moves from the first position to the second position, the cap body returns to the first position and the mouth portion is again opened by the nozzle cap. Sealing is reliably prevented, and it can be easily confirmed that the prefilled syringe is already opened. Thus, the prefilled syringe using the syringe of the present invention has an excellent tamper proof property, and it is reliably prevented from using the opened one by mistake.

Further, since the outer cover is provided, it is possible to prevent the nozzle cap from being detached from the mouth portion before use, and thereby the sealed state in which the mouth portion is sealed can be maintained.

FIG. 1 is a perspective view showing a first embodiment when the syringe of the present invention is applied to a prefilled syringe, and shows a state in which a cap body 50 is located at a first position. FIG. 2 is a cross-sectional perspective view of a portion on the distal end side of the prefilled syringe shown in FIG. 1 and shows a state in which the cap body 50 is located at the first position. FIG. 3 is a side view of the tip side portion of the prefilled syringe shown in FIG. 1 and shows a state in which the cap body 50 is located at the first position. FIG. 4 is a perspective view of the tip-side portion of the prefilled syringe shown in FIG. 1 and shows a state where the cap body 50 is located at the first position. FIG. 5 is a side view of the tip side portion of the prefilled syringe shown in FIG. 1 and shows a state where the cap body 50 is located at the second position. FIG. 6 is a cross-sectional view of the tip-side portion of the prefilled syringe shown in FIG. 1 and shows a state where the cap body 50 is located at the second position. FIG. 7 is a side view of the tip side portion of the prefilled syringe shown in FIG. 1 and shows a state where the easily breakable portion of the inner cover is broken. FIG. 8 is a perspective view of a portion on the distal end side of the outer cylinder of the prefilled syringe shown in FIG. 1. FIG. 9 is a perspective view of the inner cover of the prefilled syringe shown in FIG. FIG. 10 is a side view of the tip side portion of the second embodiment when the syringe of the present invention is applied to a prefilled syringe, and shows a state in which the cap body 50 is located at the first position. FIG. 11 is a cross-sectional view taken along line AA in FIG.

Hereinafter, the syringe of this invention is demonstrated in detail based on suitable embodiment shown to an accompanying drawing.
In the following embodiments, a case where the syringe of the present invention is applied to a prefilled syringe will be described as a representative example.

<First Embodiment>
FIG. 1 is a perspective view showing a first embodiment when the syringe of the present invention is applied to a prefilled syringe, and shows a state in which a cap body 50 is located at a first position. FIG. 2 is a cross-sectional perspective view of a portion on the distal end side of the prefilled syringe shown in FIG. 1 and shows a state in which the cap body 50 is located at the first position. FIG. 3 is a side view of the tip side portion of the prefilled syringe shown in FIG. 1 and shows a state in which the cap body 50 is located at the first position. FIG. 4 is a perspective view of the tip side portion of the prefilled syringe shown in FIG. 1 and shows a state where the cap body 50 is located at the first position. FIG. 5 is a side view of the tip side portion of the prefilled syringe shown in FIG. 1 and shows a state in which the cap body 50 is located at the second position. FIG. 6 is a cross-sectional view of the tip side portion of the prefilled syringe shown in FIG. 1 and shows a state in which the cap body 50 is located at the second position. FIG. 7 is a side view of the tip side portion of the prefilled syringe shown in FIG. 1 and shows a state where the easily breakable portion of the inner cover is broken. FIG. 8 is a perspective view of the front end portion of the outer cylinder of the prefilled syringe shown in FIG. FIG. 9 is a perspective view of the inner cover of the prefilled syringe shown in FIG.

In the following, the right side in FIGS. 1 to 3 and 5 to 9 is referred to as “tip”, the left side as “base end”, the lower side in FIG. 4 as “tip”, and the upper side as “base end”. Give an explanation. 3 to 5, the outer cover 52 is indicated by a one-dot chain line, and a portion hidden behind the outer cover 52 and not visible is indicated by a solid line.

As shown in FIGS. 1, 2, 6, and 8, a prefilled syringe (syringe) 1 includes a syringe outer cylinder (hereinafter simply referred to as “outer cylinder”) 2 and a longitudinal direction (axial direction) in the outer cylinder 2. ) And a plunger 4 for moving the gasket 3 and a cap 5 attached to the tip of the outer cylinder 2. A space 24 surrounded by the outer cylinder 2 and the gasket 3 is filled with a liquid such as the liquid preparation 200 in advance.

The outer cylinder 2 has a cylindrical outer cylinder main body 21 and a lock adapter 6 as a lock member disposed at the tip of the outer cylinder main body 21.

The outer cylinder main body 21 is formed with a reduced diameter portion 22 whose outer diameter and inner diameter are reduced at the tip. The liquid preparation 200 passes through the reduced diameter portion 22 and is discharged from the tip opening 221 thereof.

The lock adapter 6 has a ring shape, is disposed concentrically on the outer peripheral portion of the reduced diameter portion 22, and is fixed to the outer cylinder main body 21. The lock adapter 6 is for fixing the counterpart connected to the reduced diameter portion 22, and a female screw 61 is formed on the inner peripheral portion thereof. The female screw 61 can be screwed with the male screw when the counterpart has a male screw. By this screwing, the outer cylinder 2 and the counterpart are securely connected.

Also, a pair of recesses 63 is provided at the tip of the outer peripheral surface of the lock adapter 6. One and the other of the pair of recesses 63 are disposed at positions shifted from each other by 180 ° around the central axis. In addition, an inclined surface 62 is formed at a portion from the distal end of the outer peripheral surface of the lock adapter 6 to the recess 63 so that the distal end side is lower than the proximal end side. That is, the outer diameter of the lock adapter 6 gradually decreases from the position of the tip of the recess 63 to the tip of the lock adapter 6.

Further, a pair of ribs 64 extending along the longitudinal direction of the outer cylinder 2 is formed on the outer peripheral surface of the lock adapter 6 (see FIG. 8). One and the other of the pair of ribs 64 are disposed at positions shifted from each other by 180 ° around the central axis. The ribs 64 and the recesses 63 are alternately arranged in the circumferential direction of the lock adapter 6 at equal intervals, that is, at 90 ° intervals at the central angle.

In the outer cylinder 2, the reduced diameter portion 22 and the lock adapter 6 constitute the mouth portion 20 of the outer cylinder 2. The partner to be connected to the reduced diameter portion 22 is not particularly limited, and examples thereof include a connector installed at the end or intermediate portion of the tube, a mouth portion of an infusion bag, a hub of an injection needle, and the like.

The gasket 3 is made of a cylindrical elastic body, and has

protrusions

31 and 32 whose outer diameters are increased. The protrusion 31 and the protrusion 32 are spaced apart from each other along the axial direction. The

protrusions

31 and 32 slide while being in close contact with the inner peripheral surface 211 of the outer cylinder main body 21, thereby ensuring airtightness (liquid tightness) and improving the slidability. be able to.

The plunger 4 is composed of a long member, and the tip thereof is screwed with the gasket 3. When discharging the liquid preparation 200, the gasket 3 pushes out the liquid preparation 200 from the reduced diameter portion 22 by pressing the plunger 4 toward the distal end, and the discharge can be easily performed.

In addition, although it does not specifically limit as a constituent material of the outer cylinder 2 and the plunger 4, respectively, For example, various resin like polyethylene, a polypropylene, a polystyrene, a polycarbonate, cyclic polyolefin is mentioned.

The material constituting the gasket 3 is not particularly limited, but various rubber materials such as natural rubber, isoprene rubber, butadiene rubber, styrene-butadiene rubber, butyl rubber, silicone rubber, fluororubber (especially vulcanized). Treated) and various thermoplastic elastomers, and one or more of them can be used in combination.

As shown in FIGS. 1 and 2, in the prefilled syringe 1, a cap 5 is attached to the mouth portion 20 of the outer cylinder 2 in an unused state (hereinafter, this state is referred to as “attached state”). In addition, when using the prefilled syringe 1 of this mounting | wearing state, the inner side cover 51 mentioned later of the cap 5 can be folded and fractured | ruptured and can be opened.

As shown in FIG. 2, the cap 5 has a substantially cylindrical (cylindrical) inner cover 51 fixed to the outside of the distal end portion of the syringe outer cylinder 2 so that its axis is parallel to the axis of the outer cylinder 2. The cap body 50 is provided so as to be movable in the longitudinal direction (axial direction) of the inner cover 51 and covers the inner cover 51. In the illustrated configuration, the inner end of the inner cover 51 is fixed to the outside of the lock adapter 6.

The cap body 50 is disposed outside the inner cover 51, and is disposed outside the inner cover 51, the outer cover 52 provided so as to be movable in the longitudinal direction of the inner cover 51, and the outer cover 52. And a nozzle cap 53 provided to be rotatable around the axis of the outer cover 52. The nozzle cap 53 seals the mouth 20, that is, the tip opening 221 of the reduced diameter portion 22 in a liquid-tight manner, and is preferably composed of an elastic member.

Also, the outer cover 52 and the nozzle cap 53 are configured to move integrally with the outer cylinder 2 in the longitudinal direction of the outer cylinder 2. In this case, in the illustrated configuration, the outer cover 52 cannot move in the axial direction with respect to the nozzle cap 53, but can rotate around the axis. However, the present invention is not limited to this, and the outer cover 52 may not move in the axial direction with respect to the nozzle cap 53 and may not rotate about the axis.

Further, in the cap body 50, the nozzle cap 53 seals the reduced diameter portion 22 (mouth portion 20) in a liquid-tight manner, and the sealed state (hereinafter also referred to as “sealed state”) is maintained. The nozzle cap 53 is configured to be movable from the position to the second position where the nozzle cap 53 is retracted from the reduced diameter portion 22 (mouth portion 20) to the tip side by moving the outer cover 52 in the tip direction.

Hereinafter, each of the inner cover 51, the outer cover 52, and the nozzle cap 53 will be described.

The overall shape of the inner cover 51 is cylindrical, and the tip of the inner cover 51 is located closer to the tip than the tip of the mouth portion 20.

A pair of recesses 514 that can be engaged with a pair of projections 521 provided on the outer cover, which will be described later, are provided at the tip of the outer peripheral surface of the inner cover 51. Further, on the outer peripheral surface of the inner cover 51, a pair of grooves (first grooves) 511 and a pair of L-shaped grooves (second grooves) communicating with the base ends of the pair of grooves 511. 512 is provided.

The one and the other of the pair of recesses 514 are arranged at positions shifted from each other by 180 ° with the central axis as the center. In addition, one and the other of the pair of grooves 511 are arranged at positions shifted from each other by 180 ° with the central axis as the center. In addition, one and the other of the pair of grooves 512 are disposed at positions shifted from each other by 180 ° with the central axis as the center.

Since one of the pair of recesses 514 is the same as the other, the following description will be made on one recess 514 as a representative. In addition, since one of the pair of grooves 511 is the same as the other, the one groove 511 is typically described below. In addition, since one of the pair of grooves 512 is the same as the other, the following description will be made on one groove 512 as a representative.

The groove 511 is provided along the longitudinal direction of the inner cover 51, and the recess 514 is disposed on the tip side of the groove 511. The groove 511 guides the convex portion 521 when the cap body 50 moves from the first position to the second position. As shown in FIGS. 2 to 4, when the cap body 50 is located at the first position, the convex portion 521 is located at the base end of the groove 511, and as shown in FIGS. When the cap body 50 is positioned at the second position, the convex portion 521 engages with the concave portion 514.

Further, the groove 511 has an inclined surface 513 on the bottom surface thereof, in which the depth of the groove 511 decreases toward the tip. That is, the inclined surface 513 is inclined so that the tip end side is high and the base end side is low. Thereby, the convex part 521 of the outer side cover 52 contacts the inclined surface 513, whereby the cap body 50 is prevented from unintentionally moving from the first position to the second position, and the sealed state is maintained. Furthermore, an additional projection (not shown) that contacts the convex portion 521 may be provided on the base end side of the inclined surface 513. As a result, unintentional movement of the cap body 50 from the first position to the second position is more reliably prevented. In addition, it is preferable that the base end side portion of the additional protrusion is inclined so that the base end side is lower than the front end side. Accordingly, when the cap body 50 is moved from the first position to the second position, the convex portion 521 can easily get over the additional protrusion.

The groove 512 is provided from the front end of the inner cover 51 to the base end of the groove 511 and communicates with the base end side of the groove 511.

The groove 512 is used when the outer cover 52 is attached and the cap 5 is assembled. That is, when the cap main body 50 is moved to the first position when the cap main body 50 is attached to the inner cover 51 from the state where the inner cover 51 and the cap main body 50 are separated, the groove 512 causes the protrusion 521 to move. It guides from the front end of the inner cover 51 to the base end of the groove 511.

Further, a protrusion 516 is formed in the middle of the groove 512, that is, immediately before the base end portion of the groove 512.

The portion on the distal end side of the protrusion 516 is inclined so that the distal end side is lower than the proximal end side. Thus, when the cap main body 50 is attached to the inner cover 51, the cap main body 50 is moved to the first position. When moving to, the convex portion 521 can easily get over the protrusion 516.

In addition, the base end side portion of the protrusion 516 is perpendicular to the bottom surfaces of the

grooves

511 and 512, so that the convex portion 521 that has overcome the protrusion 516 returns over the protrusion 516 again. That is blocked. Accordingly, the cap body 50 is prevented from moving in the distal direction by the elastic force of the nozzle cap 53, and the work of mounting the cap body 50 on the inner cover 51 can be easily performed.

Further, as a movement preventing means that allows the convex portion 521 to move from the groove 512 to the groove 511 between the groove 511 and the groove 512 and prevents the convex portion 521 from moving from the groove 511 to the groove 512. , A protrusion 517 is provided.

The portion of the protrusion 517 on the groove 512 side is inclined so that the groove 512 side is lower than the groove 511 side, so that the convex portion 521 can move over the protrusion 517 and move from the groove 512 to the groove 511. It becomes easy. Further, the portion of the protrusion 517 on the groove 511 side is perpendicular to the bottom surface of the

grooves

511 and 512, so that the convex portion 521 positioned at the base end of the groove 511 gets over the protrusion 517 from the groove 511. The movement to the groove 512 is prevented.

In addition, the inner cover 51 can be easily broken so that the inner cover 51 can be broken into a distal end portion and a proximal end portion in the middle thereof, that is, closer to the proximal end side than the distal end of the reduced diameter portion 22 (mouth portion 20). Part 515. Then, as shown in FIG. 7, when the cap body 50 is located at the second position, the easily breakable portion 515 is broken so that the distal end portion of the inner cover 51 is moved together with the cap body 50 to the distal end portion of the outer cylinder 2. It comes to separate from. Thereby, the prefilled syringe 1 is opened. The base end portion of the inner cover 51 remains fixed to the distal end portion of the outer cylinder 2.

The easily breakable portion 515 is composed of a plurality of thin portions that are intermittently arranged around the axis of the outer cylinder 2. The easily breakable portion 515 is provided on the assumption that the inner cover 51 is broken at the easily breakable portion 515 to be broken.

Further, as described above, a pair of recesses 63 are provided on the outer peripheral surface of the lock adapter 6 of the outer cylinder 2, and as shown in FIG. 9, the proximal end portion of the inner peripheral surface of the inner cover 51, That is, a pair of claws 541 that engage with the pair of recesses 63 are provided at a position closer to the base end than the easily breakable portion 515. One and the other of the pair of claws 541 are disposed at positions shifted from each other by 180 ° around the central axis. Each claw 541 is formed with an inclined surface that is inclined so that the base end side is lower than the tip end side.

Further, as described above, a pair of ribs 64 is provided on the outer peripheral surface of the lock adapter 6 of the outer cylinder 2, and as shown in FIG. A pair of grooves 542 are provided that extend along and engage with the pair of ribs 64. Each groove 542 is formed from the base end of the inner cover 51 to the base end side of the easily breakable portion 515. In addition, one and the other of the pair of grooves 542 are arranged at positions shifted from each other by 180 ° around the central axis. The grooves 542 and the claws 541 are alternately arranged in the circumferential direction of the inner cover 51 at equal intervals, that is, at 90 ° intervals at the central angle. As a result, the ribs 64 and the grooves 542 are engaged to align the inner cover 51 with the lock adapter 6, and the circumferential positions of the recesses 63 and the claws 541 coincide.

The overall shape of the outer cover 52 has a bottomed cylindrical shape, and the front end side of the outer cover 52 is the bottom. For this reason, when the outer cover 52 is gripped with fingers, it is difficult to rotate the outer cover 52.

Further, a protruding portion 522 that protrudes in the proximal direction is provided on the inner end surface of the outer cover 52, that is, on the proximal end side of the bottom portion of the outer cover 52. As will be described later, the shape of the protruding portion 522 is such that the outer cover 52 and the nozzle cap 53 can integrally move in the longitudinal direction of the inner cover 51 with respect to the inner cover 51, and the outer cover. The shape of the nozzle cap 53 is not particularly limited as long as it can rotate in both forward and reverse directions around its axis, but the configuration shown in the drawing has a head 5221 at the base end. The portion on the tip side of the head 5221 has a columnar shape.

In addition, a pair of convex portions 521 are provided at substantially the center in the axial direction of the inner peripheral surface of the outer cover 52. One and the other of the pair of convex portions 521 are disposed at positions shifted from each other by 180 ° around the central axis.

As shown in FIGS. 5 and 6, when the cap body 50 is located at the second position, each convex portion 521 is inserted into the corresponding concave portion 514 and engaged with the corresponding concave portion 514. To do. This prevents the cap body 50 from moving in the proximal direction with respect to the inner cover 51. That is, recapping can be prevented. In addition, when the cap main body 50 is located at the second position, the anti-return means for preventing the cap main body 50 from returning from the second position to the first position by the respective convex portions 521 and the respective concave portions 514. Is configured.

Further, as shown in FIGS. 2 and 3, when the cap body 50 is located at the first position, the easily breakable portion 515 is covered by the outer cover 52. Thereby, it is possible to prevent the inner cover 51 from being broken and broken at the easily breakable portion 515.

As shown in FIGS. 5 and 6, when the cap body 50 is located at the second position, the cap body 50 is located closer to the distal end than the distal ends of the easily breakable portion 515 and the mouth portion 20. To do. That is, the proximal end of the outer cover 52 and the proximal end of the nozzle cap 53 are located on the distal end side with respect to the distal ends of the easily breakable portion 515 and the mouth portion 20, and the easily breakable portion 515 is exposed. Thereby, the inner cover 51 can be broken at the easily breakable portion 515 and broken.

Also, a pair of openings 523 are formed at the distal end portion of the outer peripheral surface of the outer cover 52, that is, at the distal end side portion from the convex portion 521. One and the other of the pair of openings 523 are disposed at positions shifted from each other by 180 ° around the central axis. Each opening 523 is configured such that when the cap body 50 is located at the first position, the tip of the inner cover 51 including the groove 511 and the recess 514 is exposed from the opening 523.

Further, a plurality of (three in the illustrated configuration) ribs 524 are formed on the base end portion of the outer peripheral surface of the outer cover 52 over the entire circumference. The ribs 524 are arranged at equal intervals along the longitudinal direction of the outer cover 52. The ribs 524 are formed on the outer cover 52 when the outer cover 52 is moved from the first position to the second position, that is, when the cap body 50 is attached to the inner cover 51. By gripping a part including the finger with a finger, it becomes slippery.

The overall shape of the nozzle cap 53 is cylindrical.
A concave portion 531 is formed on the base end surface of the nozzle cap 53, and a concave portion 532 is formed on the distal end surface.

The outer diameter of the nozzle cap 53 is set to be larger than the outer diameter of the reduced diameter portion 22 and smaller than the inner diameter of the lock adapter 6.

The concave portion 531 has a shape corresponding to the outer shape of the reduced diameter portion 22, and when the cap body 50 is located at the first position, the reduced diameter portion 22 is inserted into the concave portion 531. The distal end opening 221 of the reduced diameter portion 22 is configured to be liquid-tightly sealed by bringing the outer peripheral surface of the reduced diameter portion 22 into close contact with the inner peripheral surface of the recess 531.

Further, the concave portion 532 has a shape corresponding to the outer shape of the protruding portion 522 of the outer cover 52, and the protruding portion 522 is inserted into the concave portion 532. Thereby, the protrusion 522 is prevented from being detached from the recess 532, and the outer cover 52 and the nozzle cap 53 can move integrally with respect to the inner cover 51 in the longitudinal direction of the inner cover 51. The outer cover 52 can rotate in both forward and reverse directions around the axis of the nozzle cap 53.

In addition, although it does not specifically limit as a constituent material of the inner side cover 51 and the outer side cover 52, respectively, For example, the same material as the constituent material of the outer cylinder 2 or the plunger 4 can be used.

Further, the constituent material of the nozzle cap 53 is not particularly limited. For example, the same material as the constituent material of the gasket 3 can be used.

Next, the procedure for attaching the cap 5 to the mouth portion 20 of the outer cylinder 2 will be described. In addition, about one pair of site | parts and members, the one is demonstrated typically, respectively.

First, a nozzle cap 53 is attached to the reduced diameter portion 22 of the outer cylinder 2 to seal the tip opening 221 of the reduced diameter portion 22 in a liquid-tight manner.

Next, the inner cover 51 is attached to the lock adapter 6. In this case, first, the rib 64 and the groove 542 are engaged (see FIGS. 8 and 9). As a result, the inner cover 51 is aligned with the lock adapter 6, and the circumferential positions of the recess 63 and the claw 541 coincide. Then, the inner cover 51 is moved in the proximal direction with respect to the lock adapter 6. As a result, the claw 541 engages with the recess 63, and the base end portion of the inner cover 51 is fixed to the lock adapter 6 (see FIG. 2).

As described above, the inclined surface 62 is formed in the portion from the front end of the outer peripheral surface of the lock adapter 6 to the recess 63, and the inclined surface is also formed in the claw 541. When the inner cover 51 is attached, the inner cover 51 can be moved smoothly.

Next, as shown in FIGS. 2 to 4, the outer cover 52 is attached to the inner cover 51. At this time, first, the convex portion 521 of the outer cover 52 is inserted into the groove 512 of the inner cover 51, and the outer cover 52 is moved in the proximal direction relative to the inner cover 51. At this time, the convex portion 521 is guided in the groove 512 from the front end of the inner cover 51 and moves in the proximal direction, stops when the projection 516 is overcome, and the outer cover 52 is placed in the concave portion 532 of the nozzle cap 53. The protrusion 522 is inserted, and the cap body 50 is assembled. Since the protrusion 522 has a head 5221, it is possible to prevent the protrusion 522 from being detached from the recess 532, and the outer cover 52 and the nozzle cap 53 can move integrally. become able to.

In addition, since the site | part of the front end side of the processus | protrusion 516 is inclined, the convex part 521 can get over the processus | protrusion 516 easily. Further, since the base end side portion of the protrusion 516 is perpendicular to the bottom surfaces of the

grooves

511 and 512, the convex portion 521 that has overcome the protrusion 516 may overcome the protrusion 516 and return. Be blocked.

Next, the outer cover 52 is rotated counterclockwise in FIGS. 2 and 4 with respect to the inner cover 51. At this time, the convex portion 521 moves while being guided by the groove 512, gets over the protrusion 517, and stops at the base end of the groove 511. Thereby, the outer cover 52, that is, the cap main body 50 is disposed at the first position. At this time, the outer cover 52 can rotate in both forward and reverse directions around its axis with respect to the nozzle cap 53, so that only the outer cover 52 can be rotated counterclockwise. Thereby, the rotation operation of the outer cover 52 can be easily performed. Further, since only the outer cover 52 rotates, the sealing state of the tip opening 221 of the reduced diameter portion 22 by the nozzle cap 53 can be reliably maintained even during the rotation operation of the outer cover 52.

In addition, since the site | part by the side of the groove | channel 512 of the processus | protrusion 517 is inclined, the convex part 521 can get over the processus | protrusion 517 easily. Further, since the portion of the protrusion 517 on the groove 511 side is perpendicular to the bottom surface of the

grooves

511 and 512, the convex portion 521 positioned at the base end of the groove 511 gets over the protrusion 517 and extends from the groove 511 to the groove 512. Is prevented from moving to.

Further, when the convex portion 521 contacts the inclined surface 513, the cap body 50 is prevented from unintentionally moving from the first position to the second position, and the sealed state is maintained.

In the above procedure, the inner cover 51 may be attached to the lock adapter 6 first, and the nozzle cap 53 may be attached to the reduced diameter portion 22 of the outer cylinder 2 later.

Alternatively, after the cap body 50 is assembled with the outer cover 52 and the nozzle cap 53, the cap body 50 may be attached to the inner cover 51 and the outer cylinder 2.

Further, the timing of filling the liquid preparation 200 in the space 24 surrounded by the outer cylinder 2 and the gasket 3 may be any time as long as the nozzle cap 53 is attached to the reduced diameter portion 22 of the outer cylinder 2.

Next, the procedure for opening the prefilled syringe 1 will be described. In addition, about one pair of site | parts and members, the one is demonstrated typically, respectively.

First, as shown in FIGS. 5 and 6, the cap body 50 is moved in the distal direction with respect to the inner cover 51. That is, the cap body 50 is moved from the first position to the second position. At this time, the convex portion 521 is guided by the groove 511 and moves in the distal direction, is inserted into the concave portion 514, engages with the concave portion 514, and stops. Thereby, the cap main body 50 is held in the second position.

Further, the nozzle cap 53 is detached from the reduced diameter portion 22, retracted from the mouth portion 20, and the easily breakable portion 515 is exposed.

Next, as shown in FIG. 7, the inner cover 51 is folded at its easily breakable portion 515 and broken. Thereby, the front-end | tip part of the inner side cover 51 is isolate | separated from the front-end | tip part of the outer cylinder 2 with the cap main body 50, and the prefilled syringe 1 is opened.

Further, when the front end portion of the inner cover 51 is separated from the front end portion of the outer cylinder 2 together with the cap body 50, the reduced diameter portion 22 and the lock adapter 6 of the outer cylinder 2 are exposed. Thereby, the lock adapter 6 and the other party can be screwed together.

As described above, according to the prefilled syringe 1, when the cap main body 50 moves from the first position to the second position, the concave portion 514 and the convex portion 521 are engaged, and the cap main body 50 is in the second position. Held in position. Accordingly, it is possible to reliably prevent the refilling state, that is, recapping, and thus easily confirm that the prefilled syringe 1 has been opened. Therefore, the prefilled syringe 1 has an excellent tamper-proof property (a fact that it is once ready to be used can be confirmed later), and it is reliably prevented from using the opened one by mistake. It has become.

Further, since the recap is prevented, even if the opened prefilled syringe 1 is tampered with, it is possible to surely prevent the tampered prefilled syringe 1 from being used by mistake.

In addition, the convex portion 521 of the outer cover 52 abuts against the inclined surface 513, so that the cap body 50 is prevented from unintentionally moving from the first position to the second position, and the nozzle cap 53 is intended from the mouth portion 20. It is possible to prevent the mouth 20 from being detached without maintaining the sealing state of the mouth portion 20, thereby maintaining the sterility of the inside.

Further, when the cap body 50 is located at the first position, the inner cover 51 is covered with the outer cover 52, and therefore the inner cover 51 is unintentionally folded to break the easily breakable portion 515. Therefore, the sealed state of the mouth portion 20 can be maintained, and the internal sterility can be maintained.

In this embodiment, the concave portion 514 is provided in the inner cover 51 and the convex portion 521 is provided in the outer cover 52. However, the present invention is not limited to this, and the concave portion is provided in the outer cover 52, and the convex portion is provided in the inner cover. 51 may be provided.

Further, in the present embodiment, the convex portion 521 is located at the proximal end of the groove 511 in the mounted state. However, the present invention is not limited to this, and for example, the convex portion 521 is located at a position over the protrusion 516 of the groove 512. You may do it. In this case, when opening the prefilled syringe 1, first, the convex portion 521 is moved to the proximal end of the groove 511. Thereby, before opening the prefilled syringe 1, it can prevent more reliably that the cap main body 50 will move to a 2nd position unintentionally.

<Second Embodiment>
FIG. 10 is a side view of the tip side portion of the second embodiment when the syringe of the present invention is applied to a prefilled syringe, and shows a state in which the cap body 50 is located at the first position. FIG. 11 is a cross-sectional view taken along line AA in FIG.

In the following description, the right side in FIG. 10 is referred to as the “tip” and the left side is referred to as the “base end”. In FIG. 10, the outer cover 52 is indicated by a one-dot chain line, and a portion hidden behind the outer cover 52 and not visible is indicated by a solid line.

Hereinafter, the second embodiment will be described with a focus on differences from the first embodiment described above, and description of similar matters will be omitted.

As shown in FIGS. 10 and 11, the protrusion 517 is omitted in the prefilled syringe 1 of the second embodiment.

Also, two pairs of

second protrusions

518 and 519 are provided on the base end portion of the outer peripheral surface of the inner cover 51. One set and the other set of the two pairs of

second protrusions

518 and 519 are arranged at positions shifted from each other by 180 ° with the central axis as the center. Note that one set of the two pairs of

second protrusions

518 and 519 is the same as the other set, and therefore, in the following, typically, one set of the

second protrusions

518 and 519 will be described. explain.

Also, a pair of first protrusions 525 are provided on the proximal end portion of the inner peripheral surface of the outer cover 52. One and the other of the pair of first protrusions 525 are arranged at positions shifted from each other by 180 ° around the central axis. Since one of the pair of first protrusions 525 is the same as the other, the following description will be made on the first protrusion 525 as a representative.

First, the

second protrusions

518 and 519 are arranged in parallel along the circumferential direction with a predetermined gap therebetween. Further, the

second protrusions

518 and 519 are disposed on the proximal end side with respect to the easily breakable portion 515 of the inner cover 51. The first protrusion 525 and the

second protrusion

518, 519 are the first protrusion 525, the second protrusion 518, and the second protrusion 518, respectively, when the cap body 50 is located at the first position. It is located between two projections 519 and is arranged to engage with its

second projections

518 and 519.

Thus, when the cap body 50 is located at the first position, the cap body 50 cannot rotate in either the forward or reverse direction with respect to the inner cover 51 and the outer cylinder 2. Even if the outer cover 52 is rotated to break the easily breakable portion 515, the rotational force is transmitted to the base end side portion of the inner cover 51 with respect to the easily breakable portion 515. It is possible to prevent the easily breakable portion 515 from being broken intentionally.

Therefore, when the cap main body 50 is located at the first position by the first protrusion 525 and the

second protrusions

518 and 519, the rotational force applied to the cap main body 50 is caused by the easily breakable portion 515 of the inner cover 51. Also, a rotational force transmission preventing means for preventing transmission to the distal end side portion is configured.

When the cap body 50 is moved from the first position to the second position, the engagement between the

second protrusions

518 and 519 and the first protrusion 525 is released.

Further, when the cap body 50 is attached to the inner cover 51, the first protrusion 525 gets over the second protrusion 518 from the opposite side to the second protrusion 519, but the second protrusion 518 The portion opposite to the protrusion 519 is inclined so that the opposite side to the second protrusion 519 is lower than the second protrusion 519, whereby the first protrusion 525 causes the second protrusion 518 to move away from the second protrusion 519. It is possible to get over easily. Further, the portion of the second protrusion 518 on the second protrusion 519 side is perpendicular to the outer peripheral surface of the inner cover 51, whereby the first protrusion 525 that has overcome the second protrusion 518. However, it is prevented from overcoming the second projection 518 again and returning.

According to this prefilled syringe 1, the same effect as the first embodiment described above can be obtained.

In the prefilled syringe 1, when the cap body 50 is positioned at the first position, even if the outer cover 52 is rotated and the easily breakable portion 515 is to be broken, the rotational force of the easily filled portion of the inner cover 51 is reduced. Since it is transmitted to a portion closer to the base end than 515, it is possible to more reliably prevent the easily breakable portion 515 from being unintentionally broken, thereby maintaining the sealed state of the mouth portion 20. And maintain internal sterility.

As mentioned above, although the syringe of this invention was demonstrated based on embodiment of illustration, this invention is not limited to this, The structure of each part is substituted by the thing of the arbitrary structures which have the same function. Can do. In addition, any other component may be added to the present invention.

Further, the present invention may be a combination of any two or more configurations of the above embodiments.

Moreover, in the said embodiment, although the lock adapter 6 is fixedly installed with respect to the outer cylinder main body 21, in this invention, not only this but the lock adapter 6 is with respect to the outer cylinder main body 21, for example. It may be provided so as to be movable along the longitudinal direction of the outer cylinder 2 or to be rotatable about the axis of the outer cylinder 2. In the present invention, the lock adapter 6 may be omitted. In this case, the inner cover is fixed to a portion other than the reduced diameter portion at the distal end portion of the outer cylinder.

Moreover, although the said embodiment demonstrated the case where the syringe of this invention was applied to the prefilled syringe, the syringe of this invention is not limited to this, For example, it applies to the prefillable syringe which is not filled with the liquid. Also good.

1 Prefilled syringe 2 Syringe outer cylinder (outer cylinder)
20 mouth portion 21 outer cylinder main body 211 inner peripheral surface 22 reduced diameter portion 221 tip opening 24 space 3

gasket

31, 32 protrusion 4 plunger 5 cap 50 cap body 51

inner cover

511, 512 groove 513 inclined surface 514 recess 515 easy

breakable portion

516, 517

Protrusion

518, 519 Second protrusion 52 Outer cover 521 Protruding part 522 Protruding part 5221 Head 523 Opening 524 Rib 525 First protrusion 53 Nozzle cap 531 532 Recessed part 541 Claw 542 Groove 6 Lock adapter 61 Female screw 62 Inclined surface 63 Concave portion 64 Rib 200 Liquid preparation

Claims

A syringe having a cylindrical shape filled with a liquid, a syringe outer cylinder provided with a distal end portion including a mouth portion through which the liquid passes, and a cap attached to the mouth portion,
The cap has a substantially cylindrical inner cover fixed to the outer side of the distal end portion of the syringe outer cylinder so that its axis is parallel to the axis of the syringe outer cylinder;
An outer cover disposed on the outer side of the inner cover and movable with respect to the inner cover in a longitudinal direction of the inner cover; and disposed on the inner side of the inner cover, together with the outer cover and the inner cover. And a cap body having a nozzle cap provided so as to be movable in the longitudinal direction of the inner cover,
In the cap body, the nozzle cap seals the mouth portion in a liquid-tight manner, and the nozzle cap is moved by operating the outer cover in a distal direction from a first position where the sealed state is maintained. Moveable to a second position retracting from the mouth,
The cap has return prevention means for preventing the cap body from returning from the second position to the first position when the cap body is located at the second position;
When the cap main body is positioned at the second position, at least a part of the inner cover can be separated from the distal end portion of the syringe outer cylinder together with the cap main body.
The return prevention means has a concave portion provided on one of the inner cover and the outer cover, and a convex portion provided on the other and engaged with the concave portion,
The syringe according to claim 1, wherein when the cap body is located at the second position, the concave portion and the convex portion are engaged.
The recess is provided on the outer peripheral surface of the inner cover,
The syringe according to claim 2, wherein the convex portion is provided on an inner peripheral surface of the outer cover.
A first groove that guides the convex portion when the cap body moves from the first position to the second position is provided on the outer peripheral surface of the inner cover along the longitudinal direction of the inner cover. ,
The syringe according to claim 3, wherein the concave portion is disposed on a distal end side of the first groove.
The syringe according to claim 4, wherein the first groove has an inclined surface in which the depth of the groove decreases toward the tip at the bottom surface.
A second groove communicating with the proximal end side of the first groove is provided on the outer surface of the inner cover from the distal end of the inner cover to the proximal end of the first groove, and the convex portion is the second groove. The syringe according to claim 4, wherein the syringe is guided from the distal end of the inner cover to the proximal end of the first groove by the groove.
A protrusion that allows the convex portion to move from the second groove to the first groove and prevents the convex portion from moving from the first groove to the second groove; The syringe according to claim 6, which is provided between the groove and the second groove.
The inner cover has an easily breakable portion that can be broken so that the inner cover is separated into a distal end portion and a proximal end portion on the proximal end side from the distal end of the mouth portion,
The tip of the inner cover is separated from the tip of the syringe outer cylinder together with the cap body by breaking the easily breakable portion when the cap body is located at the second position. The syringe described.
When the cap body is located at the first position, the easily breakable portion is covered by the outer cover, and when the cap body is located at the second position, the cap body is the easily breakable portion. The syringe of Claim 8 located in the front end side rather than.
The outer cover has a first protrusion provided on the inner peripheral surface thereof,
The proximal end portion of the inner cover has a pair of second protrusions extending along the longitudinal direction of the inner cover on the outer surface thereof,
When the cap main body is positioned at the first position, the first protrusion and the second protrusion engage with each other, so that the cap main body moves around the axis of the inner cover with respect to the inner cover. The syringe according to claim 1, wherein rotation is prevented and the engagement is released when the cap body is located at the second position.
The syringe according to claim 1, wherein the syringe is a prefilled syringe in which a liquid is filled in the syringe outer cylinder.