WO2020100953A1

WO2020100953A1 - Syringe cap, syringe assembly, and prefilled syringe

Info

Publication number: WO2020100953A1
Application number: PCT/JP2019/044587
Authority: WO
Inventors: 沖原等
Original assignee: テルモ株式会社
Priority date: 2018-11-15
Filing date: 2019-11-13
Publication date: 2020-05-22
Also published as: JP7322061B2; JPWO2020100953A1

Abstract

A syringe assembly (22A) that forms a prefilled syringe (12A) is provided with a syringe cap (10A) that has an inner cap (42) and an outer cap (44). When the syringe cap (10A) is mounted on a nozzle part (14), a distal end adhering part (68) adheres circumferentially fluid-tight to a distal end outer circumferential surface (32a) of the nozzle part (14), a base end adhering part (70) adheres to a base end outer circumferential surface (32b) of the nozzle part (14), a non-adhering part (72) is spaced apart from an outer circumferential surface (32) of the nozzle part (14), and a spacing part (76) forms a gap (S2) between the spacing part (76) and an inner circumferential surface (64) of the outer cap (44).

Description

Syringe cap, syringe assembly, and prefilled syringe

The present invention relates to a syringe cap, a syringe assembly, and a prefilled syringe which are detachably attached to the barrel tip portion of a syringe having a barrel having a barrel tip portion at the tip and which seals a tip opening portion of the barrel tip portion. ..

For example, US Pat. No. 6,520,935 discloses a syringe cap having an inner cap made of an elastomeric material and a cylindrical outer cap made of a thermoplastic resin and fixed around the inner cap. It is disclosed. The inner cap has a base and a cylindrical wall extending from the base in the proximal direction. In this syringe cap, the entire inner peripheral surface of the cylindrical wall portion is in close contact with the outer peripheral surface of the cylindrical tip portion of the syringe while being attached to the cylindrical tip portion of the syringe, and the outer peripheral surface of the cylindrical wall portion is the outer cap. It is in close contact.

By the way, when the syringe cap is attached to the tip of the cylinder, the inner peripheral surface of the tubular wall may stick to the outer peripheral surface of the cylinder tip (sticking).

In the prior art as described in the above-mentioned US Pat. No. 6,520,935, the contact area of the inner peripheral surface of the cylindrical wall portion with the outer peripheral surface of the cylindrical portion in the state where the syringe cap is mounted on the cylindrical tip portion of the syringe. Since the width is large, the adhesion strength of the inner peripheral surface of the cylindrical wall portion to the outer peripheral surface of the cylindrical portion becomes relatively large. Therefore, opening of the syringe cap may not be easy.

The present invention has been made in consideration of such problems, and can reduce the sticking strength of the inner peripheral surface of the cylindrical wall portion to the outer peripheral surface of the cylinder tip portion, and can be easily opened. An object of the present invention is to provide a syringe cap, a syringe assembly, and a prefilled syringe.

A first aspect of the present invention is a syringe cap that is detachably attached to the barrel tip portion of a syringe having a barrel having a barrel tip portion at the tip, and that seals a tip opening portion of the barrel tip portion. , An elastic material, and an inner cap that liquid-tightly seals the distal end opening of the barrel tip when the syringe cap is attached to the barrel tip, and a harder material than the inner cap And a tubular outer cap fixed around the inner cap, the inner cap having a base portion and a tubular wall portion extending in a proximal direction from the base portion, The cylindrical wall portion has an inner peripheral surface that surrounds the outer peripheral surface of the cylinder tip portion, and an outer peripheral surface that faces the inner peripheral surface of the outer cap, and the inner peripheral surface of the cylindrical wall portion is the A distal end close contact portion arranged at the distal end portion of the tubular wall portion, a proximal end close contact portion disposed at the proximal end portion of the cylindrical wall portion, and an arrangement between the distal end close contact portion and the proximal end close contact portion. The outer peripheral surface of the tubular wall portion is arranged at a position corresponding to the non-contact portion in the axial direction of the tubular wall portion, and the inner portion of the outer cap is provided. When the syringe cap is attached to the barrel tip portion, the tip contact portion is tightly liquid-tightly attached to the tip outer peripheral surface of the barrel tip for one round. The proximal end contact portion is in close contact with the proximal end outer peripheral surface of the cylinder tip portion, the non-contact portion is separated from the outer peripheral surface of the cylinder tip portion, and the at least one separation portion is the separation portion and the A syringe cap that forms a gap between the outer cap and the inner peripheral surface.

A second aspect of the present invention includes the syringe cap described above and a syringe including a barrel having a barrel tip portion at a tip thereof, and the syringe cap is attached to the barrel tip portion of the barrel, It is a syringe assembly.

A third aspect of the present invention is the above-described syringe cap, a syringe including a barrel having a barrel tip at the tip, a piston slidably inserted into the barrel, the barrel and the piston. A prefilled syringe, comprising: a liquid medicine filled in a liquid chamber to be defined.

According to the present invention, when the syringe cap is attached to the barrel tip portion, the non-adhesive portion of the tubular wall portion separates from the outer circumferential surface of the barrel tip portion, so that the outer circumference of the barrel tip portion on the inner circumferential surface of the tubular wall portion. The contact area with respect to the surface can be made relatively small. Thereby, the sticking strength of the inner peripheral surface of the cylindrical wall portion to the outer peripheral surface of the cylinder tip portion can be reduced, and the syringe cap can be easily opened. Further, when the syringe cap is attached to the tip of the cylinder, a gap is formed between the separation portion and the inner peripheral surface of the outer cap, which are arranged at a position corresponding to the non-contact portion in the axial direction of the cylindrical wall portion. ing. Therefore, it is possible to effectively prevent the cylindrical wall portion from being pushed inward in the radial direction by the outer cap and the non-contact portion contacting the outer peripheral surface of the cylinder tip portion.

It is a longitudinal cross-sectional view of the prefilled syringe which concerns on 1st Embodiment of this invention. It is an exploded perspective view of the front-end | tip part of the prefilled syringe of FIG. It is a longitudinal cross-sectional view of the cap of FIG. It is a longitudinal cross-sectional view of the front-end | tip part of the prefilled syringe of FIG. FIG. 5 is a transverse sectional view taken along the line VV of FIG. 4. 6A is a first explanatory view of the opening operation of the cap of FIG. 1, and FIG. 6B is a second explanatory view of the opening operation of the cap of FIG. 1. 7A is a vertical cross-sectional view of the distal end portion of the prefilled syringe according to the second embodiment of the present invention, and FIG. 7B is a horizontal cross-sectional view taken along line VIIB-VIIB of FIG. 7A. FIG. 7B is a cross-sectional perspective view of the inner cap of FIG. 7A. It is a longitudinal cross-sectional view of the front-end | tip part of the prefilled syringe which concerns on 3rd Embodiment of this invention. FIG. 10 is a cross-sectional view taken along line XX of FIG. 9. It is a cross-sectional perspective view of the inner cap of FIG. It is a longitudinal cross-sectional view of the front-end | tip part of the prefilled syringe which concerns on 4th Embodiment of this invention. It is a disassembled perspective view of the front-end | tip part of the prefilled syringe of FIG. FIG. 13 is a cross-sectional perspective view of the inner cap of FIG. 12. FIG. 15A is a cross-sectional explanatory view showing a state in which the cap is removed from the cylinder tip portion, and FIG. 15B is a cross-sectional explanatory view showing a state in which the cap is remounted on the cylinder tip portion.

Hereinafter, preferred embodiments of a syringe cap, a syringe assembly, and a prefilled syringe according to the present invention will be described with reference to the accompanying drawings. In the following description of the prefilled syringe and its components, the left side of FIG. 1 is referred to as the “tip” and the right side is referred to as the “proximal end”.

(First embodiment)
As shown in FIG. 1, a prefilled syringe 12A according to the first embodiment of the present invention has a syringe 17 having a barrel 16 made of a hollow body provided with a barrel tip portion 14 and a barrel tip portion 14 as main components. A syringe cap 10A (hereinafter also referred to as "cap 10A") that stops, a piston 18 slidably inserted in the barrel 16, and a liquid chamber defined by the barrel 16 and the piston 18. 20 and the chemical liquid M filled therein. The syringe 17 and the cap 10A form a syringe assembly 22A.

The barrel 16 has a substantially cylindrical shape and has a body portion 24 in which a base end opening portion 23 is formed at the base end, a barrel tip portion 14 (see FIG. 2) provided at the tip of the barrel portion 24, and a barrel tip portion 14 of the barrel tip portion 14. The lock adapter 26 is provided on the outside, and the flange 28 is formed so as to project radially outward from the base end of the body portion 24. In the barrel 16 of the illustrated example, the body portion 24, the barrel tip portion 14, the lock adapter 26, and the flange 28 are integrally formed. A piston 18 is inserted into the barrel 16 via a base end opening 23. The base end side of the barrel 16 is liquid-tightly sealed by the piston 18, and the chemical liquid M is sealed in the barrel 16.

The piston 18 is a gasket made of an elastic material such as rubber. The outer periphery of the piston 18 is in liquid-tight contact with the inner peripheral surface of the barrel 16 and is slidably arranged in the barrel 16. The tip of the pusher 30 is connected to the piston 18. When the user presses the pusher 30 in the tip direction, the piston 18 slides in the barrel 16 in the tip direction. The pusher 30 may be connected to the piston 18 when the drug solution M is administered to the patient.

As shown in FIGS. 2 and 4, the barrel tip portion 14 has a diameter reduced from the tip portion of the body portion 24 with respect to the body portion 24 and extends in the tip direction. The cylinder tip portion 14 has a tapered outer peripheral surface 32 whose outer diameter decreases toward the tip end direction. That is, the outer peripheral surface 32 of the barrel tip portion 14 forms a luer taper. In FIG. 4, the cylinder tip portion 14 has a liquid passage 34 that communicates with the liquid chamber 20 in the barrel 16 and penetrates in the axial direction. The tip of the liquid passage 34 forms a tip opening 36 of the cylinder tip 14.

A needle unit (not shown) can be attached to and detached from the barrel tip 14 with the cap 10A removed from the barrel tip 14. The needle unit includes a needle body having a needle tip, and a needle hub fixed to a base end portion of the needle body and having a protrusion protruding outward. The barrel tip portion 14 can be taper-fitted to the inner peripheral portion of the needle hub. When using the prefilled syringe 12A, the cap 10A is opened (removed from the barrel tip 14 and the lock adapter 26), and the needle hub of the needle unit is connected to the barrel tip 14 and the lock adapter 26 instead.

As shown in FIGS. 2 and 4, the lock adapter 26 of the illustrated example is formed in a substantially hollow circular shape that extends from the tip of the body portion 24 in the tip direction and surrounds the barrel tip portion 14. The above-mentioned cylinder tip portion 14 projects in the distal direction from the lock adapter 26, and an annular recess 38 that is recessed in the proximal direction is formed between the lock adapter 26 and the cylinder tip portion 14. A female screw portion 40 is formed on the inner peripheral surface of the lock adapter 26. The female screw portion 40 is detachably engaged with a male screw portion 46 of the cap 10A, which will be described later. When the cap 10A is detached from the barrel 16, the female screw portion 40 can engage with the protrusion provided on the needle hub of the needle unit described above.

The lock adapter 26 of the illustrated example is provided as a part of the barrel 16 at the distal end of the body portion 24 by integral molding, but may be provided at the proximal end of the barrel tip portion 14 by integral molding. Good. Alternatively, the lock adapter 26 may be a member that is configured as a separate component from the body portion 24 and the barrel tip portion 14 and is fixed to the barrel 16 or the barrel tip portion 14.

Examples of the constituent material of the barrel 16 include polypropylene, polyethylene, polystyrene, polyamide, polycarbonate, polyvinyl chloride, poly- (4-methylpentene-1), acrylic resin, acrylonitrile-butadiene-styrene copolymer, polyethylene terephthalate and the like. And various resins such as polyester and cyclic polyolefin.

As shown in FIGS. 2 to 4, the cap 10A is detachably attached to the cylinder tip portion 14 and seals the tip end opening portion 36 of the cylinder tip portion 14. The illustrated cap 10 A is configured to be attachable to and detachable from the barrel tip 14. The cap 10 A includes an inner cap 42 that seals the tip opening 36, and a hollow cylindrical outer cap 44 that supports the inner cap 42.

The inner cap 42 is made of an elastic material. In a state in which the cap 10A is attached to the barrel tip portion 14 before use (hereinafter, also referred to as “attached state”), the inner cap 42 is liquid-tightly adhered to the barrel tip portion 14, whereby the chemical liquid is external to the cap 10A. M does not leak out. That is, the inner cap 42 liquid-tightly seals the front end opening 36 of the barrel tip 14 when the cap 10A is mounted.

Examples of the elastic material forming the inner cap 42 include various rubber materials such as natural rubber, butyl rubber, isoprene rubber, butadiene rubber, styrene-butadiene rubber, and silicone rubber, and polyurethane-based, polyester-based, polyamide-based, olefin-based materials. , Various styrene-based thermoplastic elastomers, or a mixture thereof.

The outer cap 44 is fixed to the outer circumference of the inner cap 42. A male screw portion 46 that is releasably screwed to the female screw portion 40 of the lock adapter 26 is formed on the outer peripheral portion of the base end of the outer cap 44. A stopper 48 that projects radially outward is provided on the outer peripheral portion of the outer cap 44 on the tip side of the male screw portion 46.

When the cap 10 A is firmly (completely) attached to the cylinder tip portion 14 and the lock adapter 26, the outer cap 44 is attached to the lock adapter 26 until the base end surface of the stopper 48 and the tip end surface of the lock adapter 26 come into contact with each other. It is screwed in.

Next, the configuration of the inner cap 42 will be described in more detail. The inner cap 42 has a base portion 50 located on the tip side of the cylinder tip portion 14 in the mounted state, and a cylindrical wall portion 52 extending from the base portion 50 in the proximal direction. The base portion 50 and the tubular wall portion 52 form a recess 54 that is recessed in the front end direction. The base portion 50 constitutes the tip side portion of the inner cap 42.

As shown in FIGS. 3 and 4, an annular mounting groove 56 that is recessed radially inward is provided on the outer peripheral portion of the base portion 50, and an annular projection 58 provided on the inner peripheral portion of the outer cap 44 is mounted on the mounting groove. 56 is engaged. As a result, the relative movement of the inner cap 42 and the outer cap 44 in the axial direction is prevented. In FIG. 3, the base end surface 60 of the base portion 50 (the bottom portion of the recessed portion 54) makes one round contact with the tip end surface 35 of the barrel tip portion 14, and is slightly crushed by the tip end surface 35 in the tip end direction.

In FIG. 4, the tubular wall portion 52 is formed in a hollow cylindrical shape. In the mounted state of the cap 10A, the tubular wall portion 52 surrounds the tubular tip portion 14. The cylindrical wall portion 52 includes an inner peripheral surface 62 that surrounds the outer peripheral surface 32 of the cylinder tip portion 14, and an outer peripheral surface 66 that faces the inner peripheral surface 64 of the outer cap 44.

In FIG. 3, the inner peripheral surface 62 of the cylindrical wall portion 52 is formed in a taper shape whose inner diameter expands toward the base end direction. The inner peripheral surface 62 of the tubular wall portion 52 has a distal end contact portion 68 disposed at the distal end portion of the tubular wall portion 52, a proximal end contact portion 70 disposed at the proximal end portion of the tubular wall portion 52, It has a non-adhesive portion 72 arranged between the distal end adhesive portion 68 and the proximal end adhesive portion 70.

In the mounted state of the cap 10A shown in FIG. 4, the distal end close contact portion 68 is in liquid tight contact with the distal end outer peripheral surface 32a of the cylinder tip portion 14 once, and the proximal end close contact portion 70 is in liquid tight contact with the proximal end outer peripheral surface 32b of the cylinder tip portion 14 once. And the non-contact portion 72 is separated from the outer peripheral surface 32 of the cylinder tip portion 14. That is, in the mounted state of the cap 10A, a gap S1 is formed between the non-adhesive portion 72 and the outer peripheral surface 32 of the barrel tip portion 14 so as to communicate with the tubular wall portion 52 in the circumferential direction (FIG. 4 and FIG. 4). 5).

In FIG. 3, each of the distal end close contact part 68 and the proximal end close contact part 70 extends one round in the circumferential direction of the tubular wall part 52 and expands in a tapered shape toward the proximal end direction. The non-contact portion 72 is formed by an annular groove 74 provided in the inner peripheral surface 62 of the cylindrical wall portion 52 in the circumferential direction. That is, the non-contact portion 72 extends once along the circumferential direction of the tubular wall portion 52. The depth dimension of the annular groove 74 can be arbitrarily set as long as the gap S1 can be formed between the non-adhered portion 72 and the outer peripheral surface 32 of the barrel tip portion 14 in the mounted state of the cap 10A (FIG. 4 and FIG. 4). 5).

The non-adhesion portion 72 includes an intermediate portion 73a, a distal end side taper portion 73b connecting the intermediate portion 73a and the distal end adhesion portion 68 to each other, and a proximal end side taper portion 73c connecting the intermediate portion 73a and the proximal end adhesion portion 70 to each other. Have. The intermediate portion 73a is enlarged in diameter toward the base end direction at the same taper angle as the tip close contact portion 68 and the base close contact portion 70. The tip side taper portion 73b has a diameter that increases toward the base end at a taper angle larger than that of the tip contact portion 68. The base end side taper portion 73c is reduced in diameter in the base end direction.

The length L1 (the length along the axial direction of the tubular wall portion 52) of the non-adhesive portion 72 is greater than the length L2 (the length along the axial direction of the tubular wall portion 52) of the proximal end adhesive portion 70. Is also substantially the same as the length L3 of the tip contact portion 68 (the length along the axial direction of the tubular wall portion 52). However, the length L1 of the non-adhesive portion 72, the length L2 of the proximal end adhering portion 70, and the length L3 of the distal end adhering portion 68 can be set arbitrarily.

The longer the length L1 of the non-adhesive portion 72, the smaller the sticking strength of the inner peripheral surface 62 of the cylindrical wall portion 52 to the outer peripheral surface 32 of the cylinder tip portion 14. The longer the length L2 of the proximal end contact portion 70, the more reliably the sterility of the proximal end portion of the barrel tip portion 14 can be maintained. As the length L2 of the proximal end contact portion 70 is shorter, the negative pressure in the recess 54 of the tubular wall portion 52 can be released more quickly when the cap 10A is removed from the barrel 16.

3 and 4, the outer peripheral surface 66 of the tubular wall portion 52 is arranged at a position corresponding to the non-contact portion 72 in the axial direction of the tubular wall portion 52, and is separated from the inner peripheral surface 64 of the outer cap 44. It has the separated part 76. That is, the separating portion 76 is located radially outward of the cylindrical wall portion 52 with respect to the non-contact portion 72. In the mounted state of the cap 10 A, the spacing portion 76 is configured to form a gap S 2 between the spacing portion 76 and the inner peripheral surface 64 of the outer cap 44. The spacing portion 76 is formed once along the circumferential direction of the tubular wall portion 52.

The outer peripheral surface 66 of the cylindrical wall portion 52 is provided with a protruding portion 78 protruding outward in the radial direction. The protrusion 78 is arranged at a position that coincides with the tip contact portion 68 in the axial direction of the tubular wall portion 52. That is, the protrusion 78 is located radially outward of the cylindrical wall 52 with respect to the tip contact portion 68. The protrusion 78 extends once along the circumferential direction of the tubular wall 52. The protrusion 78 is in close contact with the inner peripheral surface 64 of the outer cap 44 once. In the mounted state of the cap 10A, the protrusion 78 is compressed and deformed in the radial direction of the tubular wall portion 52 by being sandwiched between the tip outer peripheral surface 32a of the cylinder tip portion 14 and the inner peripheral surface 64 of the outer cap 44. As a result, the tip contact portion 68 strongly adheres to the tip outer peripheral surface 32a of the cylinder tip portion 14.

The opening operation of the cap 10A of the prefilled syringe 12A thus configured will be described below. In the initial state (the state in which the cap 10A is attached), as shown in FIG. 4, the distal end close contact portion 68 of the inner cap 42 tightly adheres to the distal end outer peripheral surface 32a of the cylinder tip portion 14 in a liquid-tight manner, and the proximal end close contact portion 70 forms the cylinder tip. Liquid-tightly adheres to the outer peripheral surface 32b of the base end of the portion 14 for one round. As a result, the sterility of the outer peripheral surface 32 and the distal end surface 35 of the barrel tip portion 14 (the portion where the needle hub of the needle unit described above contacts) is maintained. The non-contact portion 72 of the inner cap 42 is not in contact with the outer peripheral surface 32 of the barrel tip portion 14.

When opening the cap 10A of the prefilled syringe 12A, the user picks the outer peripheral surface of the outer cap 44 with fingers to loosen the screwing (tightening) of the male screw portion 46 of the outer cap 44 to the female screw portion 40 of the barrel 16. Rotate to.

Then, as shown in FIG. 6A, the cap 10A is displaced in the distal direction with respect to the barrel 16, and the distal end surface 35 of the barrel tip portion 14 is separated from the proximal end surface 60 of the base portion 50. Further, the base end close contact portion 70 is separated from the base end outer peripheral surface 32b of the cylinder tip portion 14, and the gap S1 between the non-contact portion 72 and the outer peripheral surface 32 of the cylinder tip portion 14 communicates with the outside. The tip contact portion 68 is in contact with the tip outer peripheral surface 32a of the cylinder tip portion 14.

Then, as shown in FIG. 6B, when the non-adhered portion 72 reaches the tip of the barrel tip portion 14, the tip-adhered portion 68 separates from the tip outer peripheral surface 32 a of the barrel tip portion 14, and inside the recess 54 of the tubular wall portion 52. Is released to the atmosphere (negative pressure in the concave portion 54 of the tubular wall portion 52 is released). As a result, the cap 10A is opened with respect to the barrel 16. It should be noted that when the non-adhered portion 72 reaches the tip of the cylinder tip portion 14, the proximal end adhered portion 70 is in a state of adhering to the tip outer peripheral surface 32a of the cylinder tip portion 14, and the inside of the recess 54 of the cylindrical wall portion 52 is open to the atmosphere. It does not have to be. In this case, the cap 10A is further displaced in the distal end direction from the state shown in FIG. 6B, and the proximal end contact portion 70 is separated from the distal end of the cylinder tip portion 14, so that the negative pressure in the concave portion 54 of the cylindrical wall portion 52 is increased. Is released, and the cap 10A is opened with respect to the barrel 16.

In this case, the syringe cap 10A, the syringe assembly 22A, and the prefilled syringe 12A according to the present embodiment have the following effects.

In the syringe cap 10 A, the inner peripheral surface 62 of the tubular wall portion 52 has a distal end contact portion 68 disposed at the distal end portion of the tubular wall portion 52 and a base disposed at the proximal end portion of the tubular wall portion 52. It has an end contact portion 70 and a non-contact portion 72 disposed between the tip end contact portion 68 and the base end contact portion 70. The outer peripheral surface 66 of the tubular wall portion 52 is arranged at a position corresponding to the non-contact portion 72 in the axial direction of the tubular wall portion 52, and has a spacing portion 76 spaced from the inner circumferential surface 64 of the outer cap 44. ing.

When the syringe cap 10A is attached to the barrel tip portion 14, the tip tight contact portion 68 tightly makes a round liquid tight fit to the tip outer peripheral surface 32a of the barrel tip portion 14, and the base end close contact portion 70 is the base end outer circumference of the barrel tip portion 14. The non-contact portion 72 is in close contact with the surface 32b, the non-contact portion 72 is separated from the outer peripheral surface 32 of the cylinder tip portion 14, and the separation portion 76 forms a gap S2 between the separation portion 76 and the inner peripheral surface 64 of the outer cap 44. To do.

According to such a configuration, when the syringe cap 10A is mounted on the barrel tip portion 14, the non-adhesive portion 72 of the barrel wall portion 52 separates from the outer peripheral surface 32 of the barrel tip portion 14, and thus the barrel wall portion 52. The contact area of the inner peripheral surface 62 with the outer peripheral surface 32 of the cylinder tip portion 14 can be made relatively small. Thereby, the adhesion strength of the inner peripheral surface 62 of the cylindrical wall portion 52 to the outer peripheral surface 32 of the cylinder tip portion 14 can be reduced, and the syringe cap 10A can be easily opened. Further, when the syringe cap 10 A is attached to the barrel tip portion 14, the spacing portion 76 and the inner peripheral surface 64 of the outer cap 44, which are arranged at the positions corresponding to the non-adhesive portion 72 in the axial direction of the tubular wall portion 52, are provided. A gap S2 is formed between them. Therefore, it is possible to effectively prevent the cylindrical wall portion 52 from being pushed inward in the radial direction by the outer cap 44 and the non-contact portion 72 coming into contact with the outer peripheral surface 32 of the cylinder tip portion 14.

The non-contact portion 72 is formed around the tubular wall portion 52 in the circumferential direction. With such a configuration, it is possible to effectively reduce the sticking strength of the inner peripheral surface 62 of the cylindrical wall portion 52 to the outer peripheral surface 32 of the cylinder tip portion 14.

The separating portion 76 is formed once along the circumferential direction of the tubular wall portion 52. With such a configuration, it is possible to further effectively prevent the cylindrical wall portion 52 from being pushed radially inward by the outer cap 44 and the non-adhesive portion 72 contacting the outer peripheral surface 32 of the cylinder tip portion 14. be able to.

The syringe assembly 22A includes the above-described syringe cap 10A and the syringe 17 including the barrel 16 having the barrel tip portion 14 at the tip thereof, and the syringe cap 10A is attached to the barrel tip portion 14 of the barrel 16. .. With such a configuration, it is possible to obtain the syringe assembly 22A having the above-described effect.

The prefilled syringe 12A includes the above-described syringe cap 10A, a syringe 17 having a barrel 16 having a barrel tip portion 14 at its tip, a piston 18 slidably inserted into the barrel 16, a barrel 16 and a piston 18. And a chemical liquid M filled in the liquid chamber 20 defined by. With such a configuration, it is possible to obtain the prefilled syringe 12A having the above-described effect.

(Second embodiment)
Next, the syringe cap 10B, the syringe assembly 22B, and the prefilled syringe 12B according to the second embodiment of the present invention will be described. In the prefilled syringe 12B according to the second embodiment, the same components as those of the prefilled syringe 12A according to the first embodiment described above are designated by the same reference numerals, and detailed description thereof will be omitted. In addition, in the present embodiment, the same effects as the configuration similar to the prefilled syringe 12A according to the first embodiment are exhibited. The same applies to the third and fourth embodiments described later.

As shown in FIGS. 7A and 7B, the prefilled syringe 12B includes a syringe 17, a syringe cap 10B (hereinafter, also referred to as “cap 10B”), a piston 18, and a drug solution M. The syringe 17 and the cap 10B form a syringe assembly 22B.

The cap 10B has an inner cap 42a and an outer cap 44. As shown in FIGS. 7A to 8, the inner cap 42a includes a base portion 50 and a cylindrical wall portion 52a having an inner peripheral surface 62a and an outer peripheral surface 66. The inner peripheral surface 62a of the cylindrical wall portion 52a has a front end contact portion 68, a base end contact portion 70, and a non-contact portion 72a (see FIG. 8). The non-contact portion 72a has a plurality of (two in the illustrated example) groove portions 80 arranged at intervals along the circumferential direction of the tubular wall portion 52a. The groove portion 80 extends in a rectangular shape in the axial direction of the tubular wall portion 52a.

The tubular wall portion 52a includes a plurality of ribs (two in the illustrated example) protruding from the inner peripheral surface 62a of the tubular wall portion 52a between two groove portions 80 adjacent to each other in the circumferential direction of the tubular wall portion 52a. 82. Thereby, the strength of the portion of the cylindrical wall portion 52a where the groove portion 80 is located can be increased by the ribs 82. Each rib 82 extends in the axial direction of the tubular wall portion 52a so as to connect the distal end contact portion 68 and the proximal end contact portion 70 to each other. In other words, the rib 82 is provided so that the protruding end surface (inner peripheral surface) thereof is flush with the distal end contact portion 68 and the proximal end contact portion 70. In the mounted state of the cap 10B, each rib 82 is in contact with the outer peripheral surface 32 of the barrel tip portion 14 (see FIG. 7B).

According to this embodiment, the same effect as that of the syringe cap 10A described in the first embodiment is obtained.

In the present embodiment, the non-contact portion 72a has a plurality of groove portions 80 arranged at intervals along the circumferential direction of the tubular wall portion 52a, and the tubular wall portion 52a is adjacent to the plurality of groove portions 80. A plurality of ribs 82 projecting from the inner peripheral surface 62a of the tubular wall portion 52a are provided between the two groove portions 80. When the syringe cap 10 B is attached to the barrel tip portion 14, the plurality of ribs 82 abut the outer peripheral surface 32 of the barrel tip portion 14.

With such a configuration, since the ribs 82 are provided, it is possible to more reliably prevent the non-adhesion portion 72a from adhering to the outer peripheral surface 32 of the barrel tip portion 14 when the syringe cap 10B is attached.

The number, depth, shape, size, etc. of the groove 80 and the rib 82 can be set arbitrarily.

(Third Embodiment)
Next, a syringe cap 10C, a syringe assembly 22C, and a prefilled syringe 12C according to the third embodiment of the present invention will be described.

As shown in FIGS. 9 and 10, the prefilled syringe 12C includes a syringe 17, a syringe cap 10C (hereinafter, also referred to as “cap 10C”), a piston 18, and a drug solution M. The syringe 17 and the cap 10C form a syringe assembly 22C.

The cap 10C has an inner cap 42b and an outer cap 44. 9 to 11, the inner cap 42b includes a base portion 50 and a cylindrical wall portion 52b having an inner peripheral surface 62b and an outer peripheral surface 66. The inner peripheral surface 62b of the cylindrical wall portion 52b has a distal end contact portion 68, a proximal end contact portion 70a, and a non-contact portion 72. The tubular wall portion 52b has a plurality of (four in the illustrated example) slits 90 (vertical grooves) that cut out the proximal end contact portion 70a along the axial direction of the tubular wall portion 52b. Each slit 90 extends from the tip end of the base end contact portion 70a to the base end. The plurality of slits 90 are arranged at intervals along the circumferential direction of the tubular wall portion 52b. The slit 90 is formed so that the depth dimension decreases toward the base end direction. Each slit 90 has a bottom surface 92 in the radial direction of the tubular wall portion 52b, and two side surfaces 93 continuous with the bottom surface 92. The two side surfaces 93 are located on both sides of the bottom wall 92 in the circumferential direction of the cylindrical wall portion 52b. The bottom surface 92 is connected to the proximal end contact portion 70a via the side surface 93. In a state where the inner cap 42b is not attached to the cylinder tip portion 14, the bottom surface 92 is located radially outward of the cylindrical wall portion 52b with respect to the base end contact portion 70a and the side surface 93. The bottom surface 92 forming the slit 90 extends substantially parallel to the axial direction of the tubular wall portion 52b (see FIG. 9).

As shown in FIG. 9, the base end portion of the bottom surface 92 of the slit 90 is in close contact with the base end outer peripheral surface 32b of the barrel tip portion 14 when the cap 10C is attached. That is, in the mounted state of the cap 10C, the inner peripheral surface 62b of the cylindrical wall portion 52b is in close contact with the base end outer peripheral surface 32b of the cylinder tip portion 14 at the base end portion of the cylindrical wall portion 52b. As a result, the base end portion of the tubular wall portion 52b is liquid-tightly sealed, so that the sterility of the base end outer peripheral surface 32b of the barrel tip portion 14 can be effectively maintained. When the cap 10C is removed from the cylinder tip portion 14, the slit 90 communicates the gap S1 formed between the non-adhesive portion 72 and the outer peripheral surface 32 of the cylinder tip portion 14 with the outside.

According to this embodiment, the same effect as that of the cap 10A described in the first embodiment is obtained.

In the present embodiment, the tubular wall portion 52b has a plurality of slits 90 that cut out the proximal end contact portion 70a along the axial direction of the tubular wall portion 52b, and when the cap 10C is removed from the tubular tip portion 14, slits are formed. 90 connects the space S1 formed between the non-contact portion 72 and the outer peripheral surface 32 of the cylinder tip portion 14 to the outside.

With this configuration, when the cap 10C is removed from the cylinder tip portion 14, the inside of the concave portion 54 of the cylindrical wall portion 52b is inserted through the gap S1 between the non-contact portion 72 and the outer peripheral surface 32 of the cylinder tip portion 14 and the slit 90. Since it can be communicated with the outside, the negative pressure in the concave portion 54 of the cylindrical wall portion 52b can be quickly released. Therefore, it is possible to prevent the chemical solution M in the barrel 16 from being drawn out by the negative pressure into the recess 54 of the cylindrical wall portion 52b.

A plurality of slits 90 are arranged along the circumferential direction of the tubular wall portion 52b. With such a configuration, when the cap 10C is detached from the cylinder tip portion 14, the negative pressure in the recess 54 of the cylindrical wall portion 52b can be reliably and quickly released.

At least one slit 90 has a bottom surface 92 in the radial direction of the tubular wall portion 52b, and when the cap 10C is attached to the barrel tip portion 14, the bottom surface 92 forming each slit 90 is a base end of the barrel tip portion 14. It adheres to the outer peripheral surface 32b. With such a configuration, the sterility of the base end outer peripheral surface 32b of the cylinder tip portion 14 can be more reliably maintained, and when the cap 10C is removed from the cylinder tip portion 14, the negative pressure in the recess 54 of the cylindrical wall portion 52b is reduced. Can be quickly released.

The number, shape, size, etc. of the slits 90 can be set arbitrarily. That is, the number of slits 90 may be one, two, three, or five or more. That is, at least one slit 90 may be provided. The slit 90 does not have to be connected to the non-contact portion 72. In this case, since the base end contact portion 70a is located between the slit 90 and the non-contact portion 72, the sterility of the base end portion of the tubular wall portion 52b can be more reliably maintained.

The respective slits 90 may be set to have the same depth over the entire length of the tubular wall portion 52b along the axial direction. In this case, when the cap 10C is removed from the cylinder tip portion 14, the gap S1 formed between the non-contact portion 72 and the outer peripheral surface 32 of the cylinder tip portion 14 can be more reliably communicated with the outside.

In the syringe cap 10C, the non-adhesive portion 72a described in the second embodiment may be provided instead of the non-adhesive portion 72. In this case, it is preferable that the groove portion 80 and the slit 90 are provided so that the positions of the cylindrical wall portion 52b in the circumferential direction coincide with each other.

(Fourth Embodiment)
Next, the syringe cap 10D, the syringe assembly 22D, and the prefilled syringe 12D according to the fourth embodiment of the present invention will be described.

As shown in FIGS. 12 to 15B, the prefilled syringe 12D includes a syringe 17, a syringe cap 10D (hereinafter, also referred to as “cap 10D”), a piston 18, and a drug solution M. The syringe 17 and the cap 10D form a syringe assembly 22D.

The cap 10D has an inner cap 42c and an outer cap 44a. The inner cap 42c includes a base portion 50a and a tubular wall portion 52c having an inner peripheral surface 62c and an outer peripheral surface 66a. The base portion 50a is a columnar portion that extends in the axial direction of the inner cap 42c.

In FIGS. 12 and 14, the inner peripheral surface 62c of the cylindrical wall portion 52c has a distal end contact portion 68, a proximal end contact portion 70b, and a non-contact portion 72. The tubular wall portion 52c has a plurality of abutting protrusions 100 that protrude radially inward from the base end portion of the base end contact portion 70b. As shown in FIG. 15A, the inner diameter of the contact projection 100 is smaller than the outer diameter of the tip of the barrel tip 14 when the cap 10D is removed from the barrel 16. As shown in FIG. 12, in the mounted state of the cap 10D, the contact protrusion 100 comes into contact with the base end outer peripheral surface 32b of the barrel tip 14. That is, in the mounted state of the cap 10D, the contact convex portion 100 is pressed outward by the cylinder tip portion 14 in the radial direction of the cylindrical wall portion 52c and is compressed and deformed.

The outer peripheral surface 66a of the cylindrical wall portion 52c is provided with a protruding portion 78a protruding outward in the radial direction. The protrusion 78a is arranged at a position that coincides with the proximal end contact portion 70b in the axial direction of the tubular wall portion 52c. The protrusion 78a extends once along the circumferential direction of the tubular wall 52c. The protrusion 78a is in close contact with an inner peripheral surface 106 of a cap cover 102, which will be described later, that forms the outer cap 44a.

As shown in FIG. 12, when the cap 10D is mounted, the protrusion 78a is compressed and deformed in the radial direction of the cylindrical wall 52c by being sandwiched between the base end outer peripheral surface 32b of the cylinder tip 14 and the cap cover 102. To do. As a result, the base end close contact portion 70b strongly adheres to the base end outer peripheral surface 32b of the barrel tip portion 14. The outer peripheral surface 66a of the tubular wall portion 52c is arranged at a position that coincides with the non-adhesive portion 72 in the axial direction of the tubular wall portion 52c, and has a spacing portion 76 that is spaced from the inner circumferential surface 106 of the cap cover 102. A gap S2 is formed between the spacing portion 76 and the inner peripheral surface 106 of the cap cover 102.

The outer cap 44a has a cap cover 102 and a tip cover member 104. The cap cover 102 has a cylindrical shape, and is made of a resin material having no transparency (substantially opaque resin material). However, the cap cover 102 may be made of a transparent material.

A male screw portion 46 and a stopper 48 are provided on the outer peripheral portion of the cap cover 102. The inner peripheral surface 106 of the cap cover 102 is provided with a plurality of engaging claws 107 and a first locking convex portion 108. The plurality of engaging claws 107 are for pressing the inner cap 42c in the distal end direction with respect to the barrel tip portion 14 when the cap 10D is removed from the barrel 16, and are arranged in the radial direction from the base end portion of the cap cover 102. It projects inward. In the mounted state of the cap 10D, the projecting end of each engagement claw 107 is located radially inward of the tubular wall portion 52c with respect to the outer peripheral surface 66a of the tubular wall portion 52c. The first locking protrusion 108 projects radially inward from the axially intermediate portion of the cap cover 102.

The tip cover member 104 has a substantially U-shaped vertical cross section, and covers the inner cap 42c so that a user who operates the cap 10D together with the cap cover 102 cannot touch the inner cap 42c. That is, the tip cover member 104 has a contact blocking function. The tip cover member 104 also has a function as a detachment prevention portion that prevents the inner cap 42c from detaching from the tip opening 110 of the cap cover 102.

As shown in FIGS. 12 and 13, the distal end cover member 104 has an annular portion 112 in which the proximal end portion is fitted to the distal end portion of the cap cover 102 so as to project from the distal end opening portion 110 of the cap cover 102 toward the distal end side. And a tip wall 114 provided at the tip of the annular portion 112.

The annular portion 112 includes an annular peripheral wall portion 116 on the front end side and a cylindrical engagement extension portion 118 extending from the annular peripheral wall portion 116 in the proximal direction. The inner diameter of the annular portion 112 is constant from the tip to the base end, and is larger than the outer diameter of the base portion 50a of the inner cap 42c.

A second locking protrusion 120, an annular recess 122, and a positioning protrusion 124 are provided on the outer peripheral portion of the engaging extension 118. The second locking projection 120 contacts the first locking projection 108 of the cap cover 102 to regulate the displacement of the tip cover member 104 in the distal direction with respect to the cap cover 102. The first locking protrusion 108 is fitted in the recess 122. The positioning protrusion 124 extends in an annular shape and comes into contact with or approaches the tip end surface of the cap cover 102.

The tip cover member 104 is integrally molded of a transparent resin material. When the cap cover 102 is made of a transparent resin material, the transparency of the tip cover member 104 is set higher than that of the cap cover 102. Accordingly, the user can visually recognize the inside of the tip cover member 104 from the outside of the cap 10D more clearly than the inside of the cap cover 102. In the present embodiment, the tip cover member 104 is colorless, but it may be colored.

In such a prefilled syringe 12D, in the mounted state of the cap 10D, the inner cap 42c is located at the first position where the base 50a is closer to the base end side than the tip opening 110 of the cap cover 102. Specifically, the tip of the inner cap 42 c is located in the proximal direction from the tip opening 110 of the cap cover 102 and within the engagement extension 118 of the tip cover member 104. As a result, the outer peripheral portion of the base portion 50a, which is the visual recognition portion, is hidden by the substantially opaque cap cover 102 and cannot be visually recognized from the outside.

When the cap 10D is opened from the barrel tip portion 14, the cap cover 102 is pulled out from the barrel 16 in a state where the male screw portion 46 and the female screw portion 40 are unscrewed. Then, as shown in FIG. 15A, the plurality of engaging claws 107 come into contact with the base end surface of the inner cap 42c. Then, the inner cap 42c is pushed in the front end direction by the plurality of engaging claws 107, and the tubular wall portion 52c is separated from the tubular tip portion 14. As a result, the cap 10D is opened.

When recapping the opened cap 10D on the tube tip portion 14, the tip end portion of the tube tip portion 14 is inserted into the cap cover 102 through the opening on the base end side of the cap cover 102. Then, as shown in FIG. 15B, the tip end portion of the barrel tip portion 14 comes into contact with the contact convex portion 100 of the inner cap 42c.

Subsequently, when the cap cover 102 and the barrel 16 are brought close to each other, the contact projection 100 of the inner cap 42c and the tip end of the barrel tip 14 contact each other, so that the inner cap 42c in the first position moves the barrel tip 42c. The base portion 50a is pushed by the portion 14 and displaced in the distal direction with respect to the cap cover 102, and the base portion 50a projects from the distal end opening portion 110 of the cap cover 102 toward the distal end side.

Then, by screwing the male screw portion 46 into the female screw portion 40, the opened cap 10D is recapped (reattached) to the barrel tip portion 14. At this time, the inner cap 42c is located at the second position where the base portion 50a is received in the receiving space S3 formed by the annular peripheral wall portion 116 and the tip wall 114. Therefore, the outer peripheral portion of the base portion 50a, which is the visible portion, can be visually recognized from the outside through the transparent tip cover member 104. This allows the user to easily determine whether or not the cap 10D has been recapped.

According to this embodiment, the same effect as that of the cap 10A according to the first embodiment is obtained.

In the syringe cap 10D, the non-contact portion 72a may be provided instead of the non-contact portion 72, or the slit 90 described in the third embodiment may be provided. Further, in the syringe cap 10D, the non-adhesive portion 72a and the slit 90 may be combined.

In the syringe cap 10A, for example, a plurality of separating portions 76 may be arranged at intervals in the circumferential direction of the tubular wall portion 52. In this case, the portions of the tubular wall portion 52 between the spacing portions 76 adjacent to each other in the circumferential direction may be in contact with the inner peripheral surface 64 of the outer cap 44 in the mounted state of the cap 10A. That is, the outer peripheral surface 66 of the tubular wall portion 52 is arranged at a position that coincides with the non-contact portion 72 in the axial direction of the tubular wall portion 52, and is separated from the inner peripheral surface 64 of the outer cap 44 by at least one space. It may have the portion 76. Even in such a case, it is possible to prevent the non-contact portion 72 from being pushed radially inward by the outer cap 44 and coming into contact with the outer peripheral surface 32 of the barrel tip portion 14. The same applies to the spacing portions 76 of the syringe caps 10B to 10D.

The syringe cap, syringe assembly, and prefilled syringe according to the present invention are not limited to the above-described embodiments, and can of course have various configurations without departing from the gist of the present invention.

Claims

A syringe cap that is detachably attached to the barrel tip portion of a syringe that includes a barrel having a barrel tip portion at its tip, and that seals a tip opening portion of the barrel tip portion.
An inner cap that is made of an elastic material and that liquid-tightly seals the tip opening of the barrel tip when the syringe cap is mounted on the barrel tip.
A cylindrical outer cap that is made of a material that is harder than the inner cap, and is fixed around the inner cap;
The inner cap has a base portion and a cylindrical wall portion extending from the base portion in a proximal direction,
The cylindrical wall portion has an inner peripheral surface surrounding the outer peripheral surface of the cylinder tip portion, and an outer peripheral surface facing the inner peripheral surface of the outer cap,
The inner peripheral surface of the tubular wall portion,
A distal end contact portion arranged at the distal end portion of the tubular wall portion,
A base end contact portion arranged at the base end portion of the tubular wall portion,
A non-adhesive portion disposed between the distal end adhering portion and the base end adhering portion,
The outer peripheral surface of the tubular wall portion is arranged at a position corresponding to the non-adhesive portion in the axial direction of the tubular wall portion, and has at least one spacing portion spaced from the inner circumferential surface of the outer cap. Have,
When the syringe cap is attached to the barrel tip portion, the distal end contact portion tightly adheres to the distal end outer peripheral surface of the barrel tip portion in a liquid-tight manner, and the proximal end contact portion is the proximal end outer peripheral surface of the barrel tip portion. And the non-contact portion is separated from the outer peripheral surface of the cylinder tip portion, and the at least one separation portion forms a gap between the separation portion and the inner peripheral surface of the outer cap. Cap for syringe.
The syringe cap according to claim 1, wherein
The syringe cap, wherein the non-adhesive portion is formed once along the circumferential direction of the tubular wall portion.
The syringe cap according to claim 1 or 2, wherein
The syringe cap, wherein the at least one separating portion is formed once along the circumferential direction of the tubular wall portion.
The syringe cap according to claim 1 or 3, wherein
The non-adhesive portion has a plurality of groove portions arranged at intervals along the circumferential direction of the tubular wall portion,
The tubular wall portion has a plurality of ribs protruding from the inner peripheral surface of the tubular wall portion between two adjacent groove portions of the plurality of groove portions,
The syringe cap, wherein the plurality of ribs abut the outer peripheral surface of the barrel tip when the syringe cap is mounted on the barrel tip.
The syringe cap according to any one of claims 1 to 4,
The tubular wall portion has at least one slit that cuts out the proximal end contact portion along the axial direction of the tubular wall portion,
The syringe cap, wherein when the inner cap is removed from the barrel tip, the slit communicates the gap formed between the non-contact portion and the outer peripheral surface of the barrel tip with the outside.
The syringe cap according to claim 5, wherein
The syringe cap in which a plurality of the at least one slits are arranged along the circumferential direction of the tubular wall portion.
The syringe cap according to claim 5 or 6, wherein
The at least one slit has a bottom surface in the radial direction of the tubular wall portion,
The syringe cap, wherein the bottom surface of the at least one slit is in close contact with the proximal outer peripheral surface of the cylinder tip portion when the syringe cap is attached to the cylinder tip portion.
A syringe cap according to any one of claims 1 to 7,
A syringe having a barrel having a barrel tip at the tip,
The syringe cap, wherein the syringe cap is attached to the barrel tip portion of the barrel.
A syringe cap according to any one of claims 1 to 7,
A syringe provided with a barrel having a barrel tip at the tip,
A piston slidably inserted into the barrel;
A prefilled syringe comprising: a liquid medicine filled in a liquid chamber defined by the barrel and the piston.