The present disclosure generally relates to a lock adapter, a syringe assembly, and a prefilled syringe for an injector.
Prefilled syringes in which a syringe is filled with a medicinal solution (i.e., medicine) in advance have been widely used. In some prefilled syringes, a lock adapter is attached to the periphery of a nozzle portion at the tip end of the syringe, and a cap covering the nozzle portion is screwed into a female screw of the lock adapter for sealing.
Japanese Patent Application Publication No. 2008-35913 A discloses a prefilled syringe having a slidable lock adapter in which the lock adapter is configured to be slidable in the axial direction. In this prefilled syringe, a slide portion for allowing the lock adapter to slide in the axial direction is provided at a base portion of the nozzle portion. The slide portion is provided with six rotation restricting ribs extending in the axial direction to prevent rotation of the lock adapter, and an annular rib extending in the circumferential direction along a boundary between the slide portion and the base portion of a luer tip.
Furthermore, the lock adapter is provided with six claw portions extending inward. The claw portions of the lock adapter are disposed between the rotation restricting ribs and configured to slide in the axial direction along the outer surface of the slide portion. In addition, when the cap is screwed on the lock adapter, the claw portions of the lock adapter are caught by the annular rib, so that the lock adapter is prevented from coming off from the slide portion while withstanding the tightening load of the cap.
In the conventional lock adapter, the claw portions of the lock adapter are relatively fragile, and when the autoclave sterilization process is performed in a state where the cap is screwed on the lock adapter, the strength of the claw portions becomes insufficient due to application of heat. As a result, the claw portions might not be able to withstand the load acting from the cap, and thus may be deformed.
Variation may thus be increased in the position on the tip end side of the lock adapter after being subjected to the autoclave sterilization process, so that it may be difficult to keep the position within the desired dimensional tolerance.
A lock adapter, a syringe assembly, and a prefilled syringe are disclosed, which are capable of suppressing variation in position on the tip end side of the lock adapter after being subjected to an autoclave sterilization process.
One aspect of the following disclosure is a lock adapter attached to the periphery of a nozzle portion at the tip end of a prefilled syringe and configured to be slidable in the axial direction of the nozzle portion, the lock adapter including: a cylindrical body portion surrounding the periphery of the nozzle portion; and a claw portion protruding to the inner peripheral side from a base end portion of the cylindrical body portion, the claw portion configured to determine a tip end position of the lock adapter by being caught in an annular rib extending in the circumferential direction of the nozzle portion, in which the claw portion has a circumferential shape when viewed from the axial direction and is integrally connected in the circumferential direction.
Another aspect of the disclosure is a syringe assembly that includes: a syringe body having a lumen configured to accommodate a medicinal solution; a nozzle portion at the tip end of the syringe body; and a lock adapter attached to the outer periphery of the nozzle portion, in which the nozzle portion includes: a slide portion on the base end side and on which the lock adapter is slidable in the axial direction; a luer tip on the tip end side of the slide portion; and an annular rib extending and protruding in the circumferential direction along a boundary between the luer tip and the slide portion, the lock adapter includes: a cylindrical body portion surrounding the periphery of the nozzle portion; and a claw portion protruding to the inner peripheral side from a base end portion of the cylindrical body portion, the claw portion configured to determine a tip end position of the lock adapter by being caught in the annular rib extending in the circumferential direction of the nozzle portion, and the claw portion of the lock adapter has a circumferential shape when viewed from the axial direction and is integrally connected in the circumferential direction.
Yet another aspect of the disclosure is a prefilled syringe including: a syringe body having a lumen accommodating a medicinal solution; a gasket to be inserted from the base end side of the syringe body to seal the lumen; a nozzle portion at the tip end of the syringe body; a lock adapter attached to the outer periphery of the nozzle portion; and a cap to be screwed into the lock adapter to seal the nozzle portion, in which the nozzle portion includes: a slide portion provided on the base end side and on which the lock adapter is slidable in the axial direction; a luer tip provided on the tip end side of the slide portion; and an annular rib extending and protruding in the circumferential direction along a boundary between the luer tip and the slide portion, the lock adapter includes: a cylindrical body portion surrounding the periphery of the nozzle portion; and a claw portion protruding to the inner peripheral side from a base end portion of the cylindrical body portion, the claw portion configured to determine a tip end position of the lock adapter by being caught in the annular rib extending in the circumferential direction of the nozzle portion, and the claw portion of the lock adapter has a circumferential shape when viewed from the axial direction and is integrally connected in the circumferential direction.
With the lock adapter, the syringe assembly, and the prefilled syringe in the above-mentioned aspects, since the claw portion of the lock adapter is less likely to be deformed during the autoclave sterilization process, it is possible to suppress variation in the position on the tip end side of the lock adapter.
Set forth below with reference to the accompanying drawings is a detailed description of embodiments of a lock adapter, a syringe assembly, and a prefilled syringe for an injector. Note that since embodiments described below are preferred specific examples of the present disclosure, although various technically preferable limitations are given, the scope of the present disclosure is not limited to the embodiments unless otherwise specified in the following descriptions.
Hereinafter, preferred embodiments of a lock adapter 22, a syringe assembly 50, and a prefilled syringe 10 will be described in detail with reference to the accompanying drawings. It should be noted that in the following description, the side of a nozzle portion 18 of the prefilled syringe 10 is referred to as the tip end or the tip end side, and the side of a flange portion 16 of the prefilled syringe 10 is referred to as the base end or the base end side. In addition, an alternate long and short dash line A in the drawings represents an axis of the prefilled syringe 10, and the direction of the alternate long and short dash line A is referred to as the axial direction.
As illustrated in
The gasket 15 is configured to be slidable in the axial direction while liquid-tightly sealing the inside of the lumen 13, and a portion of the lumen 13 closer to the tip end side than the gasket 15 is a drug chamber that is liquid-tightly sealed by the gasket 15. The drug chamber of the lumen 13 sealed by the gasket 15 is filled with a medicinal solution or a liquid preparation such as injection water or saline (or saline solution) for dilution in advance. The prefilled syringe 10 may be provided to a user in a state where a plunger is attached, and in such a case, a plunger (pusher) for pressing the gasket 15 may be attached to the gasket 15. As a constituent material of the gasket 15, a rubber material having elasticity, an elastomer material, or the like can be used.
At the base end of the syringe body 12, the flange portion 16 is formed to protrude radially outward. A finger grip can be attached to the flange portion 16. In the prefilled syringe 10, the finger grip may be attached to the flange portion 16 in advance. In addition, the flange portion 16 and the finger grip may be integrally formed (i.e., formed together).
A neck portion 17 having a diameter smaller than that of the syringe body 12 is formed at the tip end of the syringe body 12. From the neck portion 17, the nozzle portion 18 is formed to protrude toward the tip end side. As illustrated in
A syringe barrel 20 including the syringe body 12, the flange portion 16, and the nozzle portion 18 can be formed of a transparent resin material or glass, which helps enable the lumen 13 to be visually recognized. Furthermore, a scale for recognizing the liquid amount of the medicinal solution may be provided at the side portion of the syringe body 12.
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An inner peripheral surface 30a (see
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In order to help ensure compatibility and to help prevent erroneous connection, the position of the female screw 25 and the position of the tip end surface 22b of the lock adapter 22 in the tip end position of the lock adapter 22 are defined by a corresponding standard. For example, according to ISO 80369-7, which is a standard related to small-diameter syringes, the axial dimension c from the tip end surface 18b of the nozzle portion 18 to the tip end surface 22b of the lock adapter 22 is defined to fall within 2.100 mm to 2.573 mm.
As a constituent material of the lock adapter 22, for example, a resin material such as polypropylene, polyethylene, polycarbonate, polyester, or cyclic polyolefin can be used. Among the materials for the lock adapter 22, a heat-resistant resin such as polypropylene or cyclic polyolefin is preferably used from the viewpoint of helping prevent deformation of the lock adapter 22 during heating in autoclave sterilization.
As illustrated in
The slide portion 33 is formed between the tip end of the neck portion 17 and the base end of the annular rib 32. The slide portion 33 is formed in a cylindrical shape having a constant outer diameter size, and has the rotation restricting rib 36 and a slide lock portion 38 on an outer peripheral portion of the slide portion 33. The rotation restricting rib 36 protrudes outward from the outer peripheral portion of the slide portion 33 and extends in the axial direction. The rotation restricting rib 36 can be formed over the entirety of the slide portion 33 in the axial direction. The radial protrusion height of the rotation restricting rib 36 is less than the radial protrusion height of the annular rib 32. That is, the rotation restricting rib 36 is formed at such a height that does not divide the annular rib 32 in the circumferential direction. A pair of the rotation restricting ribs 36 is formed spaced apart from each other by 180° in the circumferential direction. It should be noted that the number of the rotation restricting ribs 36 is not limited to two, and the number of the rotating restricting ribs 36 may be one or three or more.
The slide lock portion 38 includes a tip end convex portion 38a for holding the lock adapter 22 at the tip end position and a base end convex portion 38b for holding the lock adapter 22 at the base end position. The tip end convex portion 38a protrudes at substantially the same height as that of the annular rib 32. As illustrated in
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The luer tip housing portion 44 for housing the luer tip 34 is formed on the inner peripheral side of the attachment portion 42. The luer tip housing portion 44 extends to the side of the body portion 40. A seal member 48 is attached to the innermost portion of the luer tip housing portion 44. The seal member 48 can be made of a rubber material, and when the cap 24 is screwed into the innermost portion, the seal member is elastically compressed and comes into close contact with the tip end surface 18b of the nozzle portion 18 to seal the flow path 18a.
An opposing surface 40a opposing to the tip end surface 22b of the lock adapter 22 is formed on the base end side of the body portion 40. The opposing surface 40a is provided with an anti-loosening protrusion 40b engaging with the lock protrusion 27 to help prevent loosening of the cap 24. When the cap 24 is screwed, the anti-loosening protrusion 40b engages with the lock protrusion 27 to keep the cap 24 in a tightly screwed state. The cap 24 can be, for example, formed of a material similar to that of the lock adapter 22.
The syringe assembly 50 of the present embodiment is configured by attaching the lock adapter 22 to the syringe body 12.
The lock adapter 22, the syringe assembly 50, and the prefilled syringe 10 of the present embodiment are configured as described above, and the operation the lock adapter 22, the syringe assembly 50, and the prefilled syringe 10 will be described below.
A plurality of syringe assemblies 50 are collectively accommodated in a packaging container called a nested tab container in a sterilized state and distributed, and are provided to a sterile filling facility. In the sterile filling facility, filling of each syringe assembly 50 (syringe body 12) with a medicinal solution (i.e., medicine) and capping with the cap 24 and the gasket 15 are performed. Thereafter, autoclave sterilization is performed on the syringe body 12 in which the medicinal solution is sealed, and the prefilled syringe 10 in
As described above, the autoclave sterilization of the prefilled syringe 10 is performed in a state where the cap 24 is screwed into the lock adapter 22. As illustrated in
In a prefilled syringe 100 of a comparative example illustrated in
As illustrated in
In contrast, in the syringe assembly 50 and the prefilled syringe 10 of the present embodiment, a protruding height of the rotation restricting rib 36 is less than the protruding height of the annular rib 32 in the nozzle portion 18. That is, the rotation restricting rib 36 does not divide the annular rib 32. Therefore, as illustrated in
As a result, as illustrated in
The lock adapter 22, the syringe assembly 50, and the prefilled syringe 10 of the present embodiment have the following effects.
The lock adapter 22 of the present embodiment relates to the lock adapter 22 attached on the periphery of the nozzle portion 18 at the tip end of the prefilled syringe 10 and configured slidable in the axial direction of the nozzle portion 18. The lock adapter 22 includes: the cylindrical body portion 23 formed in a cylindrical shape surrounding the periphery of the nozzle portion 18; and the claw portion 30 protruding to the inner peripheral side from the base end portion 28 of the cylindrical body portion 23, and configured to determine the tip end position of the lock adapter 22 by being caught in the annular rib 32 extending in the circumferential direction of the nozzle portion 18. The claw portion 30 is formed in a circumferential shape when viewed from the axial direction and is integrally connected in the circumferential direction.
With the above configuration, the rigidity of the claw portion 30 can be enhanced. In addition, the tightening load of the cap 24 is dispersed over a relatively wide range in the circumferential direction of the claw portion 30. As a result, even when autoclave sterilization is performed in a state where the tightening load of the cap 24 acts on the claw portion 30, deformation of the claw portion 30 can be prevented, and variations in the axial position of the tip end surface 22b of the lock adapter 22 and the axial position of the female screw 25 can be suppressed.
The lock adapter 22 may further include the rotation restricting protrusion 31a that protrudes inward from the claw portion 30 and engages with the rotation restricting rib 36 extending in the axial direction of the nozzle portion 18. With this configuration, it is possible to realize a configuration capable of preventing the rotation of the lock adapter 22 without dividing the claw portion 30 in the circumferential direction.
The syringe assembly 50 of the present embodiment includes the syringe body 12 having the lumen 13 capable of accommodating a medicinal solution (i.e., medicine), the nozzle portion 18 formed at the tip end of the syringe body 12, and the lock adapter 22 attached to the outer periphery of the nozzle portion 18. In the syringe assembly 50, the nozzle portion 18 includes the slide portion 33 provided on the base end side and on which the lock adapter 22 is slidable in the axial direction, the luer tip 34 provided on the tip end side of the slide portion 33, and the annular rib 32 extending and protruding in the circumferential direction along the boundary between the luer tip 34 and the slide portion 33. The lock adapter 22 includes the cylindrical body portion 23 formed in a cylindrical shape surrounding the periphery of the nozzle portion 18, and the claw portion 30 protruding to the inner peripheral side from the base end portion 28 of the cylindrical body portion 23, and configured to determine a tip end position of the lock adapter 22 by being caught in the annular rib 32 extending in the circumferential direction of the nozzle portion 18. The claw portion 30 of the lock adapter 22 is formed in a circumferential shape when viewed from the axial direction and can be integrally connected in the circumferential direction.
With the above-described syringe assembly 50, the deformation of the claw portion 30 can be prevented, and variations in the axial position of the tip end surface 22b of the lock adapter 22 and the axial position of the female screw 25 can be suppressed.
In the syringe assembly 50 described above, the rotation restricting rib 36 extending in the axial direction is formed on the slide portion 33 of the nozzle portion 18, and the protruding height of the rotation restricting rib 36 may less than the protruding height of the annular rib 32. With the above-described configuration, since it is not necessary to form the claw portion 30 in the circumferential shape of the lock adapter 22 so as to avoid the rotation restricting rib 36, the claw portion 30 can be integrally formed. As a result, the strength of the claw portion 30 can be improved, and deformation of the claw portion 30 can be suppressed.
In the syringe assembly 50 described above, the rotation restricting rib 36 may be formed inward of the claw portion 30 of the lock adapter 22. With this configuration, since the rotation restricting rib 36 is positioned inside the claw portion 30, the rotation restricting rib 36 does not interfere with the claw portion 30, and the claw portion 30 can be integrally formed in the circumferential direction.
In the syringe assembly 50 described above, the rotation restricting protrusion 31a may be formed that protrudes inward from the inner peripheral surface 30a of the claw portion 30 of the lock adapter 22 and engages with the rotation restricting rib 36. With this configuration, rotation of the lock adapter 22 can be prevented.
In the syringe assembly 50 described above, the notch 32c for allowing the rotation restricting protrusion 31a to pass through the notch 32c may be formed at a portion adjacent in the circumferential direction to the rotation restricting rib 36 of the annular rib 32. With this configuration, upon attaching the lock adapter 22 to the nozzle portion 18, the rotation restricting protrusion 31a can rather easily pass through the annular rib 32, which makes the assembly of the lock adapter 22 to the nozzle portion 18 to be rather easy. Furthermore, it is possible to prevent breakage of the annular rib 32 and the rotation restricting protrusion 31a at the time of assembly of the lock adapter 22 to the nozzle portion 18.
In the syringe assembly 50 described above, the tip end surface 32a of the annular rib 32 can be gradually reduced in diameter and inclined toward the tip end side, and the base end surface 32b of the annular rib 32 may be erected perpendicularly to the axial direction. With this configuration, upon attaching the lock adapter 22 to the nozzle portion 18, the claw portion 30 can rather easily cross over the annular rib 32, which is preferable. In addition, since the base end surface 32b of the annular rib 32 is formed to be erected upright, even when the tightening load of the cap 24 or the like acts on the claw portion 30, it is possible to help prevent the claw portion 30 from falling off from the annular rib 32 to the tip end side, which is preferable.
The prefilled syringe 10 of the present embodiment includes the syringe body 12 accommodating a medicinal solution in the lumen 13, the gasket 15 to be inserted from the base end side of the syringe body 12 to seal the lumen 13, the nozzle portion 18 formed at the tip end of the syringe body 12, the lock adapter 22 attached to the outer periphery of the nozzle portion 18, and the cap 24 screwed into the lock adapter 22 to seal the nozzle portion 18. The nozzle portion 18 of this prefilled syringe 10 includes the slide portion 33 provided on the base end side and on which the lock adapter 22 is slidable in the axial direction, the luer tip 34 provided on the tip end side of the slide portion 33, and the annular rib 32 extending and protruding in the circumferential direction along the boundary between the luer tip 34 and the slide portion 33. The lock adapter 22 includes the cylindrical body portion 23 formed in a cylindrical shape surrounding the periphery of the nozzle portion 18, and the claw portion 30 protruding to the inner peripheral side from the base end portion 28 of the cylindrical body portion 23, and configured to determine the tip end position of the lock adapter 22 by being caught in the annular rib 32 extending in the circumferential direction of the nozzle portion 18. The claw portion 30 of the lock adapter 22 is formed in a circumferential shape when viewed from the axial direction and is integrally connected in the circumferential direction.
With the prefilled syringe 10 configured as described above, the deformation of the claw portion 30 can be prevented, and variations in the axial position of the tip end surface 22b of the lock adapter 22 and the axial position of the female screw 25 can be suppressed.
Although the present disclosure has been described above with reference to preferred embodiments, the present disclosure is not limited to the above embodiments, and it goes without saying that various modifications can be made without departing from the gist of the present disclosure. For example, in the present embodiment, the lock adapter may be separate from the prefilled syringe and configured to slide, or may be separate and configured not to slide.
The detailed description above describes embodiments of a lock adapter, a syringe assembly, and a prefilled syringe for an injector. These disclosed embodiments represent examples of the lock adapter, the syringe assembly, and the prefilled syringe for an injector disclosed here. The invention is not limited, however, to the precise embodiments and variations described. Various changes, modifications and equivalents can be effected by one skilled in the art without departing from the spirit and scope of the invention as defined in the accompanying claims. It is expressly intended that all such changes, modifications and equivalents which fall within the scope of the claims are embraced by the claims.
Number | Date | Country | Kind |
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2020-052002 | Mar 2020 | JP | national |
This application is a continuation of International Application No. PCT/JP2021/008873 filed on Mar. 8, 2021, which claims priority to Japanese Patent Application No. 2020-052002 filed on Mar. 24, 2020, the entire content of both of which is incorporated herein by reference.
Number | Date | Country | |
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Parent | PCT/JP2021/008873 | Mar 2021 | US |
Child | 17933150 | US |