JP2005230458A - Injector for pre-filled syringe, pre-filled syringe, and method for inspecting cap fitting state in pre-filled syringe - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide an injector for a pre-filled syringe for easily confirming whether or not a cap is reliably screwed so as to seal a nozzle part. <P>SOLUTION: The injector 10 for a pre-filled syringe comprises: an outer cylinder 2 having an outer cylinder body 21 and the nozzle part 22 which is arranged at the tip end of the outer cylinder body; a cap 3 attached to the nozzle part; a gasket 4 stored in the outer cylinder 2; and a pusher 5. The nozzle part 22 includes: a chip part 24 for mounting a syringe needle, whose diameter is reduced toward the tip end; and a nozzle side screw part 25 arranged at a rear end side from the chip part 24. The cap 3 comprises: a chip storage part 49 for storing the chip part 24; a cap side screw part 50 to be screwed onto the nozzle side screw part 25; and a marker 31 for confirming a fitting state between the cap 3 and the chip part 24 where the chip part 24 is reliably sealed by the chip storage part 49. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

  The present invention relates to a so-called prefilled syringe syringe prefilled with a chemical solution, a prefilled syringe prefilled with a chemical solution, and a cap fitting state inspection method for a prefilled syringe.

Prior to administration of an infusion solution to a patient, various drugs such as vitamins, minerals, and antibiotics are blended into the infusion solution filled in the infusion container as necessary. Moreover, in the field of emergency medical care, multiple combined use and large-scale administration of an autonomic nerve action drug, a pressor medicine, etc. are performed with the syringe. Such compounding and administration of drugs are performed by sucking a drug solution from a vial with a syringe and then injecting the drug solution into an infusion container or directly into a blood vessel. However, the compounding and administration of such a drug has a drawback in that the operation is complicated, and it takes a long time for compounding and administration. Therefore, a so-called prefilled syringe that is preliminarily filled with a chemical solution has been proposed.
Since the prefilled syringe may be stored for a certain period from filling the chemical solution into the inside until use, it is necessary to prevent the chemical solution from deteriorating during that time.
Therefore, conventionally, when a cap made entirely of rubber or a seal member having elasticity such as rubber is placed inside a cap made of synthetic resin and the cap is placed on the nozzle of the syringe, the tip opening of the nozzle is A type of prefilled syringe that is in close contact with and sealed with a seal member is used. These are all or partly formed of rubber, and are not necessarily preferable materials for the cap from the viewpoint of disposal.
Thereafter, a prefilled syringe having no sealing member, having a shape that seals the cap and the nozzle portion of the syringe together, and improving the sealing performance by fitting the two together is manufactured. As this type of prefilled syringe syringe, the applicant of the present application has proposed one disclosed in Patent Document 1 (Japanese Patent Laid-Open No. 2002-172165).
The syringe for a prefilled syringe of Patent Document 1 includes an outer cylinder main body part, a nozzle part provided on the distal end side of the outer cylinder main body part, and a flange provided on the rear end side of the outer cylinder main body part. And a cap attached to the nozzle portion in a liquid-tight and detachable manner. The nozzle part includes a nozzle body part, an outer cylinder side screwing part, and an outer cylinder side engaging part. The cap includes a nozzle body housing portion, a cap side screwing portion that is screwed with the outer cylinder side screwing portion, and a cap side that engages with the outer cylinder side engaging portion when the cap is liquid-tightly attached to the nozzle portion. It has an engagement portion, and has a high rotational resistance in a direction away from the nozzle portion of the cap.

JP 2002-172165 A

Although the thing of the said patent document 1 has a sufficient effect, it cannot confirm whether the cap is fitted in the state which sealed the nozzle part reliably. For this reason, there is a risk that a poor fitting, in other words, a product that is not completely sealed may be shipped, and that it was completely sealed at the time of shipment, but has been loosened by use and is no longer completely sealed. I couldn't.
Therefore, an object of the present invention is to provide a prefilled syringe injector and a prefilled syringe that can easily confirm whether or not the cap is securely fitted in a state where the nozzle portion is sealed.
Moreover, the objective of this invention is providing the cap fitting state test | inspection method of the prefilled syringe which can confirm rapidly and reliably whether the cap is fitted in the state which sealed the nozzle part reliably.

The following objects are achieved.
(1) an outer cylinder main body, an outer cylinder provided with a nozzle portion provided at a distal end portion of the outer cylinder main body portion and having an open front end, a cap detachably attached to or attached to the nozzle portion, A syringe for a prefilled syringe comprising a gasket slidably housed in an outer cylinder, and a pusher attached to or attachable to the rear end of the gasket,
The nozzle portion includes a tip portion for mounting an injection needle that decreases in diameter toward the tip, and a nozzle side screwing portion provided on the rear end side from the tip portion,
The cap includes the tip portion housing portion that houses the tip portion and seals the tip portion of the tip portion, the cap side screwing portion that is screwed with the nozzle side screwing portion, and the tip portion housing portion. A syringe for prefilled syringes, comprising: a marker for confirming a fitting state between the nozzle side screwing part and the cap side screwing part in which the tip part is surely sealed.

(2) The outer cylinder includes a second marker provided at a position facing the portion where the marker is located when the tip portion is securely sealed by the tip portion storage portion. The syringe for prefilled syringes as described in (1) above.
(3) The outer cylinder includes an outer cylinder side engaging portion provided at a rear end side with respect to the outer cylinder side screwing portion, and the cap is at an opening end side of the cap with respect to the cap side screwing portion. And a cap-side engaging portion that engages with the outer-cylinder-side engaging portion, and in the state where the outer-cylinder-side engaging portion and the cap-side engaging portion are engaged with each other, the cap Is a syringe for a prefilled syringe according to the above (1) or (2), which seals the tip portion.
(4) The cap includes a sealing portion that protrudes from the tip closing surface of the tip portion storage portion toward the opening end side, enters the tip opening of the tip portion, and seals the tip opening. The tip portion storage portion includes a small-diameter portion that can be liquid-tightly contacted with the tip portion of the tip portion and that clamps the tip portion of the tip portion in cooperation with the sealing portion. The pre-filled syringe injector according to any one of (1) to (3), wherein the portion storage portion has a shape that does not substantially contact the tip portion at a portion other than the small diameter portion.

(5) The prefilled syringe injector according to (4), wherein the sealing portion of the cap includes a free end and is reduced in diameter toward the free end.
(6) Any of the above (1) to (5), wherein the marker is a rib formed near the open end of the cap and on the inner surface at a position slightly closer to the closed end than the open end of the cap. A syringe for a prefilled syringe according to claim 1.
(7) The marker is a rib formed near the open end of the cap and on an inner surface at a position slightly closer to the closed end side than the open end of the cap, and the rib is an open end of the cap. A smooth bottom surface portion provided at a position closer to the closed end side, a smooth side surface portion extending from both ends of the smooth bottom surface portion to the closed end side of the cap, and an inner portion surrounded by the smooth bottom surface portion and the smooth side surface portion The syringe for a prefilled syringe according to any one of the above (1) to (6), further comprising a surface portion, and a corner portion of the inner surface portion and the smooth bottom surface portion having a sharp edge. .
(8) The syringe for a prefilled syringe according to (7), wherein the rib has a sharp edge at a corner between the inner surface portion and the smooth side surface portion.
(9) The prefilled syringe syringe according to (7) or (8), wherein the cap is formed of a material in which a clear change in shading is caused by light reflected by the rib.
(10) The syringe for a prefilled syringe according to any one of (1) to (9), wherein the cap is made of a highly transparent material.

Moreover, what achieves the said objective is as follows.
(11) The syringe for prefilled syringes according to any one of (1) to (10), and a medicine stored in a space formed by the outer cylinder, the gasket, and the cap. Prefilled syringe.
(12) The prefilled syringe according to (11), wherein the prefilled syringe is sterilized by high-pressure steam.

Moreover, what achieves the said objective is as follows.
(13) an outer cylinder main body part, an outer cylinder provided with a nozzle part provided at a distal end part of the outer cylinder main body part, and a cap attached detachably to or attachable to the nozzle part; A syringe for a prefilled syringe comprising a gasket slidably accommodated in the outer cylinder and a pusher attached to or attachable to the rear end of the gasket, wherein the nozzle portion is directed toward the tip. A tip portion for reducing the diameter of the injection needle, and a nozzle-side threaded portion provided on the rear end side from the tip portion, and the cap accommodates the tip portion and holds the tip portion of the tip portion. A tip portion storage portion to be sealed, a cap side screw portion to be screwed with the nozzle side screw portion, a marker for confirming a fitting state between the cap side screw portion and the nozzle side screw portion; Have And it is a cap fitting state inspection method of a prefilled syringe filled with a medicine inside,
The marker is a rib formed on the inner surface of the cap, and the inspection method is performed at a position where the marker is located when the tip portion is securely sealed by the tip portion storage portion. Light is applied from above the part where the marker is located, and the marker is confirmed from the part where the marker is located when the tip part is securely sealed by the tip part storage part. A method for inspecting a cap fitting state of a prefilled syringe, characterized in that:

(14) The marker is a rib formed near the opening end of the cap and on the inner surface at a position slightly closer to the closing end side than the opening end of the cap, and the cap fitting state inspection of the prefilled syringe The prefilled syringe according to (13), wherein the method is to apply light obliquely from above the portion where the marker is located and to confirm the marker position using light collected by the rib forming the marker. Cap state inspection method.
(15) In the cap fitting state inspection method for the prefilled syringe, light is applied from above the portion where the marker is located, and the tip portion is securely sealed by the tip portion storage portion. The pre-filled syringe cap fitting state inspection method according to the above (13) or (14), wherein light is applied from the back surface of the portion where the marker is located.
(16) When the tip portion is securely sealed by the tip portion storage portion, the light source form of light applied from the back surface of the portion where the marker is located is wider surface illumination than the entire cap. The cap-filled state inspection method for a prefilled syringe according to (15) above.

The syringe for a prefilled syringe of the present invention includes an outer cylinder main body, an outer cylinder provided with a nozzle portion provided at a distal end portion of the outer cylinder main body portion, and a cap that is attached to or attachable to the nozzle portion. And a prefilled syringe syringe comprising a gasket slidably accommodated in the outer cylinder and a pusher attached to or attachable to the rear end of the gasket, the nozzle portion at the tip A tip portion for mounting an injection needle that is reduced in diameter toward the tip, and a nozzle side screwing portion provided on the rear end side from the tip portion, and the cap accommodates the tip portion and the tip of the tip portion A tip portion storage portion that seals the nozzle portion, a cap side screw portion that is screwed to the nozzle side screw portion, and the nozzle side screwing that ensures that the tip portion is sealed by the tip portion storage portion. And a marker for confirming the fitting state between the cap side thread portion and.
For this reason, it can be easily confirmed from the appearance whether or not the marker is at a predetermined value and whether or not the tip portion is securely sealed by the tip portion storage portion.

The outer cylinder includes a second marker provided at a position facing the portion where the marker is located when the tip portion is reliably sealed by the tip portion storage portion. If so, it can be confirmed from the appearance whether or not the marker is at a predetermined value and whether or not the tip portion is securely sealed by the tip portion storage portion.
The prefilled syringe of the present invention comprises the above prefilled syringe injector, and a medicine accommodated in a space formed by the outer cylinder, the gasket, and the cap.
For this reason, it can be easily confirmed from the appearance whether or not the marker is at a predetermined value and whether or not the tip portion is securely sealed by the tip portion storage portion.

In addition, the prefilled syringe cap fitting state inspection method of the present invention includes an outer cylinder main body, an outer cylinder including a nozzle portion provided at a distal end portion of the outer cylinder main body portion, and an open end of the outer cylinder main body portion; A syringe for a prefilled syringe comprising a cap that can be attached or attachable, a gasket that is slidably accommodated in the outer cylinder, and a pusher that is attached or attachable to the rear end of the gasket. The nozzle portion includes an injection needle mounting tip portion that decreases in diameter toward the tip, and a nozzle side screwing portion provided on the rear end side from the tip portion, and the cap includes the tip A tip portion storage portion that houses the tip portion and seals the tip portion of the tip portion, a cap side screw portion that screw-engages with the nozzle side screw portion, the nozzle side screw portion, and the cap side screw portion. With And a marker for confirming the combined state, and a cap fitting state inspection method for a prefilled syringe filled with a medicine therein, wherein the marker is a rib formed on the inner surface of the cap, In the inspection method, when the tip portion is securely sealed by the tip portion storage portion, light is applied to a portion where the marker is located from above the portion where the marker is located, and When the tip portion is securely sealed by the tip portion storage portion, the marker is confirmed from the side where the marker is located.
For this reason, it can be easily confirmed optically whether the marker is at a predetermined value.

The marker is a rib formed near the opening end of the cap and on an inner surface at a position slightly closer to the closing end side than the opening end of the cap, and the cap fitting state inspection method of the prefilled syringe If the marker position is confirmed by using light collected from the rib forming the marker to confirm the marker position, the marker is at a predetermined value. The optical confirmation is more reliable.
Further, the marker is a rib formed near the opening end of the cap and on the inner surface at a position slightly closer to the closed end side than the opening end of the cap, and the rib is formed from the opening end of the cap. A smooth bottom surface provided at a position slightly closer to the closed end, a smooth side surface extending from both ends of the smooth bottom surface to the closed end of the cap, and an inner surface surrounded by the smooth bottom surface and the smooth side surface If the corner portion between the inner surface portion and the smooth bottom surface portion has a sharp edge, the light irradiated from the closed end side of the cap is reflected by the smooth bottom surface portion. In addition, the reflected light is reflected by the smooth side surface portion, so that only the rib can be strongly shined.
Further, if the rib has a sharp edge at the corner between the inner surface portion and the smooth side surface portion, the light irradiated from the closed end side of the cap is reflected by the smooth bottom surface portion. Furthermore, since the reflected light is reflected by the smooth side surface portion, it becomes possible to make only the ribs shine more intensely.

The prefilled syringe cap fitting state inspection method applies light from above the portion where the marker is located, and the tip portion is securely sealed by the tip portion storage portion. If the light is applied from the back of the part where the marker is located, the height position of the cap can be easily confirmed.
Further, when the tip portion is securely sealed by the tip portion storage portion, the light source form of light applied from the back surface of the portion where the marker is located may be a surface illumination wider than the entire cap. In this case, the height position of the cap can be confirmed more easily.

The syringe for prefilled syringe and the prefilled syringe of the present invention will be described with reference to embodiments shown in the drawings.
FIG. 1 is a partially broken front view of a prefilled syringe using a prefilled syringe injector according to an embodiment of the present invention. FIG. 2 is an enlarged cross-sectional view of the distal end portion of the prefilled syringe shown in FIG. FIG. 3 is an enlarged view of the distal end portion of the outer cylinder used in the prefilled syringe injector of the present invention. 4 is a longitudinal sectional view of the outer cylinder shown in FIG. FIG. 5 is a plan view of the outer cylinder shown in FIG. FIG. 6 is a front view of a cap used in the prefilled syringe of the present invention. 7 is a bottom view of the cap shown in FIG. FIG. 8 is a plan view of the cap shown in FIG. 9 is a cross-sectional view taken along line AA in FIG.
The syringe 10 for a prefilled syringe according to the present invention is attached to the outer cylinder body 21, the outer cylinder 2 including the nozzle part 22 provided at the distal end of the outer cylinder main body 21 and having the distal end opened, and the nozzle part 22. An attachable cap 3, a gasket 4 slidably accommodated in the outer cylinder 2, and a pusher 5 attached to or attachable to the rear end of the gasket 4 are provided. The nozzle portion 22 includes an injection needle mounting tip portion 24 that decreases in diameter toward the tip, and a nozzle side screwing portion 25 provided on the rear end side from the tip portion 24. The cap 3 has the tip portion 24 securely sealed by the tip portion receiving portion 49 for receiving the tip portion 24, the cap side screwing portion 50 screwed with the nozzle side screwing portion 25, and the tip portion receiving portion 49. It has the marker 31 for confirming the fitting state of the cap 3 and the chip | tip part 24 used as a state.

The prefilled syringe 1 of the present invention includes a prefilled syringe syringe 10 and a medicine 62 accommodated in a space formed by the outer cylinder 2, the gasket 4 and the cap 3 of the syringe 10.
As shown in FIG. 1, the prefilled syringe syringe 10 of the embodiment includes an outer cylinder 2, a cap 3 attached to the nozzle portion 22 of the outer cylinder 2, and a gasket slidably accommodated in the outer cylinder 2. 4 and a pusher 5 attached to the gasket 4.
The outer cylinder 2 is a cylindrical body formed of a transparent or translucent material, preferably a material having low oxygen permeability and water vapor permeability.
The outer cylinder 2 includes an outer cylinder main body portion 21, a nozzle portion 22 provided at the distal end portion of the outer cylinder main body portion 21, and a flange 23 provided at the rear end portion of the outer cylinder main body portion 21.
The outer cylinder main body portion 21 is a substantially cylindrical portion that accommodates the gasket 4 in a liquid-tight and sliding manner, and the nozzle portion 22 is a cylindrical portion having a smaller diameter than the outer cylinder main body portion 21. Further, the distal end portion (shoulder portion) of the outer cylinder main body portion 21 is tapered toward the nozzle portion 22 in a tapered shape.
As shown in FIGS. 1 and 5, the flange 23 is an elliptical donut-shaped disk portion formed so as to protrude in the vertical direction from the entire rear end circumference of the outer cylinder main body portion 21. The flange 23 includes two gripping portions 23a and 23b that are wide facing each other, and a plurality of ribs are formed on the front end face side of the gripping portions 23a and 23b. Further, the rear end surface of the flange 23 has a concave portion at the peripheral edge and the outer cylinder rear end portion other than the rib portion.

As shown in FIGS. 3 and 4, the nozzle portion 22 includes an injection needle mounting tip portion 24 that decreases in diameter toward the tip, and a nozzle-side screwing portion 25 provided on the rear end side from the tip portion 24. ing. In particular, in this embodiment, the nozzle portion includes a nozzle base portion 36 provided between the base end of the tip portion 24 and the outer cylinder main body portion 21.
The nozzle base 36 is formed in a substantially cylindrical shape in front of the outer cylinder main body 21. The axial length of the nozzle base is preferably 2 to 6 mm, particularly about 3 to 5 mm. The nozzle side screwing portion 25 is formed on the outer surface of the nozzle base portion 36, and fits with the cap side screwing portion 50 formed on the inner surface of the base end portion of the cap 3. In this embodiment, the screw thread 25a has two spiral shapes.
The tip portion 24 is formed in front of the nozzle base portion 36 and has a tapered diameter toward the tip so that an injection needle can be attached. The length of the tip portion 24 in the axial direction is preferably about 5 to 10 mm, particularly about 7 to 9 mm. Moreover, it is preferable to form the annular thick portion 26 at the tip portion 24a of the tip portion 24 as in this embodiment. In this embodiment, the annular thick portion 26 is formed by providing an annular rib 38 on the inner surface of the tip portion of the tip portion 24.

  Specifically, as shown in FIG. 4, the annular thick portion 26 is formed by providing an annular rib 38 on the inner surface of the tip opening of the tip portion 24. As shown in FIG. 4, the annular thick portion 26 is thicker than other portions of the tip portion 24. In addition, the inner surface of the annular rib 38 of the annular thick portion 26 is made substantially smooth so as to be in close contact with the outer surface of the sealing portion 58 of the cap 3 described later. The inner surface of the annular rib 38 of the annular thick portion 26 may gradually increase in diameter in a tapered shape toward the tip. As a result, the inner surface of the annular thick portion 26 becomes closer to the outer surface of the sealing portion 58. The thickness of the annular thick portion 26 is made substantially the same as or slightly thicker than the gap inside the small diameter portion (in other words, the tip portion storage portion) 52 of the cap 3 that is an annular storage space. For this reason, when the chip part 24 is pushed into the chip part tip part storage part 52, the annular thick part 26 is stored in the storage part 52 in a liquid-tight and air-tight manner. Specifically, the tip end portion storage portion in which the inner surface of the annular rib 38 of the annular thick portion 26 is in liquid-tight and air-tight contact with the outer surface of the sealing portion 58 and the outer surface of the annular thick portion 26 is a small diameter portion. 52 is in liquid-tight and air-tight contact with the inner surface. For this reason, according to the syringe for prefilled syringes of the present invention, since the seal member has a sealing property equivalent to that of a known cap disposed therein, it is possible to prevent deterioration of the chemical solution stored in the syringe. Moreover, the chemical | medical solution inside a syringe does not leak outside.

  The axial width of the annular thick portion 26 is not particularly limited as long as it is strong enough not to be damaged or deformed when the sealing portion 58 is inserted into the tip opening 29 surrounded by the annular thick portion 26. However, it is preferably 0.2 to 1.5 mm, particularly preferably 0.5 to 1.0 mm. The height of the annular thick portion 26 from the inner surface of the nozzle is preferably such that it does not hinder the discharge of the chemical solution, which is the original function of the nozzle (particularly when connected to the female connector of the infusion set or three-way cock). 0.1 to 1.0 mm, and particularly preferably 0.2 to 0.5 mm. The wall thickness of the annular thick portion 26 is preferably slightly larger than the gap between the tip portion tip portion storage portion 52 where the tip portion tip portion storage portion 52 and the annular thickness portion 26 are in close contact with each other. Although it depends on the material, it is preferably about 10 to 500 μm, particularly 100 to 300 μm. Specifically, the thickness of the annular thick portion 26 is preferably about 0.5 to 1.5 mm, particularly about 0.8 to 1.2 mm.

  Further, the thick portion may be formed by providing an annular rib on the outer surface of the tip opening (not shown). It is preferable that the outer surface of the thick-walled annular rib be made smooth so as to be in close contact with the inner surface of the distal end portion of the storage portion. The outer surface of the annular rib may be gradually tapered in a tapered shape toward the tip. Further, the inner surface of the nozzle tip opening may be gradually increased in a tapered shape toward the tip. Further, the thickness of the thick part is made thicker than the gap inside the tip part storage part as described above. Specifically, the thickness of the thick part is approximately the same as or slightly smaller than the gap near the entrance (near the rear end) of the tip end storage part, except for the vicinity of the entrance of the tip part storage part. It is made thicker than the gap. Even in such a configuration, as described above, when the nozzle tip is pushed into the tip storage part, the outer surface of the annular rib of the thick part comes into liquid-tight and air-tight contact with the inner surface of the storage part, and the thick part ( The inner surface of the tip opening portion is in liquid-tight and air-tight contact with the outer surface of the sealing portion.

  The thick portion may be formed by providing annular ribs on both the inner surface of the tip opening and the outer surface of the tip opening (not shown). It is preferable that the inner surface and the outer surface of the annular rib are formed substantially smoothly. Further, the inner surface of the inner annular rib may be gradually increased in a tapered shape toward the tip. Further, the outer surface of the outer annular rib may be gradually tapered in a tapered shape toward the tip. Specifically, the thickness of the thick part is almost the same as or slightly narrower than the gap near the entrance (near the rear end) of the tip end storage part, except for the vicinity of the entrance of the tip end storage part It is made thicker than the gap. With this configuration, when the nozzle tip is stored in the tip storage part, the inner surface of the inner annular rib of the tip opening and the outer surface of the sealing part, and the outer surface of the outer annular rib and the inner surface of the storage part are liquid-tight and air-tight. To touch. In the embodiment of the present invention, the annular thick portion 26 is provided at the front end opening of the tip portion 24, but may be provided slightly on the rear end side from the front end opening 29.

  The syringe 10 preferably includes cap-side engaging portions 55 and 56 provided on the cap 3 and outer cylinder-side engaging portions 43 and 44 provided on an outer cylinder engaged with the cap-side engaging portions 55 and 56. Specifically, as shown in FIGS. 3, 4, and 5, an enlarged diameter portion 42 that is larger in diameter than the nozzle base portion 36 is formed at the boundary between the nozzle portion 22 and the outer cylinder main body portion 21. Outer cylinder side engaging portions 43 and 44 that engage with the cap side engaging portions 55 and 56 are formed on the outer surface of the enlarged diameter portion 42. Two outer cylinder side engaging parts 43 and two outer cylinder side engaging parts 44 are formed so as to face each other. It is preferable that the outer cylinder side engaging part is disposed so as to be equiangular with respect to the central axis. Specifically, projections 43a and 43b and projections 44a and 44b projecting in the radial direction are provided on the outer surface of the diameter-expanded portion 42, and a concave outer cylinder side engagement portion 43 is formed by the projections 43a and 43b. Is done. Similarly, a concave outer cylinder side engaging portion 44 is formed by the protrusions 44a and 44b. Further, when the concave portion is formed between two projections as in this embodiment, when the cap 3 is attached, the projections of the cap-side engaging portions 55 and 56 come into contact first, and the projection 43a on the side to get over, It is preferable to make 44a small.

  In addition, it is preferable to make the other protrusions 43b and 44b large enough to prevent the cap-side engaging portions 55 and 56 from getting over. Furthermore, the protrusion of the cap-side engagement portion comes into contact first, and the engagement portion contact surface of the protrusions 43a and 44a on the overcoming side is formed as an inclined surface that becomes higher in the screwing rotation direction of the cap. preferable. By doing in this way, engagement with the cap side engaging part mentioned later becomes easy. With the configuration as described above, when the cap 3 is placed on the nozzle portion 22 and rotated in the screwing advance direction, the cap-side engagement portion abuts on and gets over the protrusions 43a and 44a and is formed between the protrusion 43a and the protrusion 43b. The cap 3 is attached to the outer cylinder 2 by engaging with the concave portion 43 and the concave portion 43 between the projection 44a and the projection 44b.

  Examples of the material for forming the outer cylinder 2 include polypropylene, polyethylene, polystyrene, polyamide, polycarbonate, polyvinyl chloride, poly- (4-methylpentene-1), acrylic resin, acrylonitrile-butadiene-styrene copolymer, polyethylene terephthalate. Various resins such as polyester and cyclic polyolefin can be used, and among them, resins such as polypropylene and cyclic polyolefin are preferable because they are easy to mold and have heat resistance. Moreover, as a forming material of the outer cylinder 2, it is preferable to use a resin whose hardness is relatively higher than that of the cap 3 in order to improve sealing performance. If it does in this way, when attaching the cap to a nozzle, a cap will stick to a nozzle with screwing operation, and it can improve sealability more.

Next, the cap 3 will be described.
7 and 8, the cap 3 includes a cap part (in other words, an inner cylinder part) 45, an outer cylinder part 46 formed so as to surround the cap part 45, and the cap part 45 and the outer cylinder part. The connecting portion 60 is formed between 46. The cap part 45 and the outer cylinder part 46 are integrated by the entire periphery of the rear end part and the connecting part 60. The connecting portion 60 is disposed between the outer surface of the cap portion 45 and the inner surface of the outer cylinder portion 46, and six connecting portions 60 are disposed at an equal angle with respect to the central axis. The connecting portion 60 extends slightly from the rear end side to the rear end portion (a portion where the cap portion 45 and the outer cylinder portion 46 are continuous) from the front end of the cap portion 45.
As shown in FIGS. 7 and 9, the cap 3 includes a tip portion storage portion 49 that stores the injection needle mounting tip portion 24 of the nozzle portion of the outer cylinder, and a cap side screw that is screwed to the nozzle side screwing portion 25. A joining portion 50 and a sealing portion 58 that enters the tip opening 29 of the chip portion 24 and seals the tip opening 29 are provided. Furthermore, in this embodiment, the cap 3 includes cap side engaging portions 55 and 56 that engage with the outer tube side engaging portion of the outer tube.

The base end portion 49 a of the cap portion 45 is a cylindrical space having substantially the same inner diameter, and a cap-side screwing portion 50 that engages with the nozzle-side engaging portion 25 is provided on the inner surface. In this embodiment, the screw thread 50a has two spiral shapes.
The tip portion storage portion 49 includes a small-diameter portion 52 that can be liquid-tightly contacted with the tip portion of the tip portion 24 in an annular manner and that clamps the tip portion of the tip portion 24 in cooperation with the sealing portion 58. Furthermore, the tip portion storage portion 49 has a shape that does not substantially contact the tip portion 24 at portions other than the small diameter portion 52.
Specifically, the tip portion accommodating portion 49 is a space where the portion excluding the distal end portion (small diameter portion) 52 is reduced in diameter from the proximal end portion 49a and gradually reduced in a tapered shape toward the distal end. Yes. The gently tapered portion (center portion) 49 b is larger than the outer diameter of the tip portion 24 and does not contact the tip portion 24. For this reason, the sealing by the tip end portion 24a is not hindered, and the tip portion can be easily inserted into the storage portion.

The tip portion 52 of the chip portion storage portion 49 has a smaller diameter than the central portion 49b, and is a columnar space having substantially the same inner diameter. In addition, the front-end | tip part of a storage part may be a taper shape toward the front-end | tip. The tip portion of the tip portion 24 is in annular and linear contact with the inner surface of the small diameter portion 52 of the storage portion 49 to form a liquid-tight and air-tight body. That is, the contact between them is not a surface contact having a certain width in the so-called axial direction but a linear contact. In addition, the boundary between the central portion 49b and the tip 52 is tapered toward the tip.
Behind the base end portion 49 a of the cap portion 45, it is formed by the rear end surface of the cap portion 45 and the inner surface of the rear end portion of the outer cylinder portion 46, and is formed at the boundary between the nozzle portion 22 and the outer cylinder main body portion 21. A storage space 54 for storing the enlarged diameter portion 42 is formed. The storage space 54 is a short cylindrical space whose diameter is larger than that of the base end portion 49a. In addition, two cap side engaging portions 55 and 56 that engage with the outer cylinder side engaging portions 43 and 44 are formed on the inner side surface of the storage space 54. The cap-side engaging portions 55, 56 are ribs adjacent to the ribs 55a, 56a that protrude inward so as to face the inner surface of the storage space 54, and in the direction opposite to the screwing direction of the ribs 55a, 56a. It consists of slopes 55b and 56b formed so as to become higher toward 55a and 56a. By having such inclined surfaces 55b and 56b, the ribs 55a and 56a can easily get over the cap-side protrusions 43a and 44a. The ribs 55a and 56a are formed to have a rectangular cross section, but the present invention is not limited to this, and the cross section may be a semicircular shape, a semi-elliptical shape, or the like. With such a configuration, when the cap 3 is rotated in the screwing advance direction, the cap side engaging portions 55 and 56 get over the outer cylinder side engaging portions 43a and 44a, respectively, and the outer cylinder side engaging portion 43a and the outer It engages with a recess formed between the cylinder side engaging portion 43b and a recess formed between the outer tube side engaging portion 44a and the outer cylinder side engaging portion 44b.

As shown in FIG. 7, the sealing portion 58 protrudes from the distal end blocking surface of the storage portion 49 toward the opening end 3 a side, enters the distal end opening 29 of the nozzle portion 22, and seals the distal end opening 29. The sealing portion 58 is a rod-shaped portion having a circular cross section that protrudes from the center of the front end surface of the storage portion 49 toward the rear end. The sealing portion 58 is gradually tapered in a tapered shape toward the free end, and the end portion is rounded. Further, the sealing portion 58 is formed in a size that can be sealed closely to the tip opening 29 of the nozzle portion 22.
Further, as shown in FIG. 7, the cap 3 is formed narrower than the annular thick portion 26 formed between the tip 52 and the sealing portion 58 of the storage portion 49, and the annular thick portion 26 is liquid-tight and air-tight. Is provided with a small-diameter portion (tip portion tip portion storage portion) 52 to be stored.
The distal end storage portion 52 is a substantially annular space formed between the inner surface of the distal end portion 52 of the storage portion 49 and the outer surface of the sealing portion 58. The width of the annular space (difference between the inner radius of the small diameter portion and the outer radius of the sealing portion) is gradually increased toward the distal end side of the outer diameter of the sealing portion 58 and the storage portion 49. The diameter is reduced. Further, the gap near the entrance of the tip portion storage portion 52 is formed to be approximately the same as or slightly larger than the thickness of the annular thick portion 26, and the width of the portion excluding the vicinity of the entrance of the tip portion storage portion 52 is the annular shape of the tip portion 24. The diameter is smaller than the thickness of the thick portion 26. For this reason, when the cap portion 45 is attached to the nozzle portion 22, the tip portion 24 is attached to the tip portion storage portion 52 in a liquid-tight and air-tight manner.

As shown in FIGS. 6, 7, and 9, the outer tube portion 46 is a portion used to grip the cap 3, and includes a grip portion 47 formed so as to surround the cap portion 45, and the cap portion. A cylindrical portion 48 formed behind the grip portion 47 so as to surround 45 is provided.
The grip portion 47 is formed in a substantially hexagonal cylindrical shape. Anti-slip 47 a is provided on each outer surface of the grip portion 47. Note that the anti-slip 47 a may not be provided on the outer surface of the support portion 47. Further, as shown in FIG. 8, the hexagonal corner portion of the grip portion 47 is formed in a shape such that the cross section in the radial direction is almost semicircular. In addition, the grip portion 47 is formed with a larger diameter than the cylindrical portion 48. Further, the tip of the grip part 47 protrudes forward from the tip of the cap part 45.
The cylindrical portion 48 continues to the grip portion 47 and extends to the rear of the grip portion 47. The rear end portion of the cylindrical portion 48 protrudes from the rear end of the cap portion 45. The cylindrical portion 48 is continuous with the rear end surface of the cap portion 45 on the side surface of the rear end portion.

  A marker 31 is formed in the vicinity of the opening end 3a of the cap 3 as shown in FIGS. In this embodiment, the marker 31 is a rib formed on the inner surface of the cap that is slightly on the closed end side from the tip opening end 3a. Further, as shown in FIG. 7, two markers 31a and 31b are provided at opposite positions. The marker 31 is in a state in which the cap-side screwed portion 50 of the cap 3 and the nozzle-side screwed portion 25 of the outer cylinder 2 are screwed together and the tip portion 24 is securely sealed by the tip portion storage portion 49. In this state, it is provided so as to be at a predetermined position. For this reason, by confirming the position of the marker 31, it is possible to easily grasp whether or not the tip portion 24 is reliably sealed by the tip portion storage portion 49. In this embodiment, as shown in FIG. 7, the markers 31 a and 31 b are provided in the vicinity of the seal cap side engaging portions 55 and 56.

  Further, as shown in FIG. 13, the marker 31 is a rib formed on the inner surface in the vicinity of the opening end 3 a of the cap as described above and at a position that is slightly closed from the opening end 3 a of the cap 3. . Furthermore, the rib is provided with a smooth bottom surface portion 131 provided at a position slightly closer to the closed end side than the opening end 3a of the cap, and smooth side surface portions 132a and 132b extending from both ends of the smooth bottom surface portion 131 to the closed end side of the cap 2. It is preferable to include an inner surface portion 133 surrounded by the smooth bottom surface portion 131 and the smooth side surface portions 132a and 132b. Furthermore, it is preferable that the corner portions of the inner surface portion 133 and the smooth bottom surface portion 131 have a sharp edge shape. By doing in this way, the light irradiated from the closed end 3a side of the cap 3 is reflected by the smooth bottom surface portion 131, and further, the reflected light is reflected by the smooth side surface portion 132, so that only the rib is formed. It becomes possible to make it shine strongly. Furthermore, it is preferable that the rib which is the marker 31 has an edge shape with sharp corners between the inner surface portion 133 and the smooth side surface portions 132a and 132b. By doing in this way, the light irradiated from the closed end side of the cap is reflected by the smooth bottom surface portion, and further, the reflected light is reflected by the smooth side surface portion, so that only the ribs are shined more strongly. It becomes possible.

In this embodiment, the marker 31 is preferably a rib formed on the inner surface of the cap 3 described above, but is not limited thereto. For example, the rib formed on the outer surface of the cap, the cap It may be a concave portion formed on the inner surface or the outer surface, a colored portion formed on the outer surface of the cap, a magnetic index provided on the outer surface of the cap, or the like. Further, the position of the marker is not limited to the vicinity of the end opening end of the cap 3, and may be anywhere.
Examples of the material for forming the cap 3 include polypropylene, polyethylene, polystyrene, polyamide, polycarbonate, polyvinyl chloride, poly- (4-methylpentene-1), acrylic resin, acrylonitrile-butadiene-styrene copolymer, polyethylene terephthalate, and the like. Among these, various resins such as polyester and cyclic polyolefin are preferable. Among them, resins such as polypropylene and cyclic polyolefin are preferable because they are easy to mold and have heat resistance. In particular, it is preferable to use a mixture of polypropylene and an elastomer as the material for forming the seal cap. As the elastomer, it is preferable to use thermoplastic elastomers such as butadiene rubber, ethylene-propylene rubber, and silicone rubber. By mixing the elastomer in this manner, elasticity is imparted to the resin, so that the cap 3 and the nozzle portion 22 are easily brought into close contact with each other, and the sealing performance is enhanced. Although the blending ratio of polypropylene and elastomer depends on the type of elastomer, it is preferable to mix so that polypropylene: elastomer is about 75:25 to 45:65. Moreover, it is preferable to produce the nozzle part 22 (outer cylinder 2) and the cap 3 with compatible resin. Thereby, the nozzle part 22 and the seal cap 3 become easy to closely_contact | adhere, and the sealing performance of a chemical | medical solution becomes high. Specifically, the outer cylinder is preferably made of polypropylene, and the cap is preferably made of a mixture of polypropylene and an elastomer.

In particular, the cap is preferably formed of a material that strongly reflects light at an edge portion of a rib that is a marker. Specifically, it is preferable that the cap is formed of a material in which a clear change in shading is caused by light reflected by the rib. The cap is preferably formed of a highly transparent material. Specifically, polypropylene, polystyrene, polycarbonate, and cyclic polyolefin as described above are preferable.
With the above configuration, the cap 3 is attached to the nozzle portion 22 as follows. When the cap 3 is put on the nozzle portion 22 and rotated in the screwing advance direction, first, the cap side screwing portion 50 provided at the base end portion of the cap 3 and the nozzle side screwing portion 25 of the nozzle base portion 36 are screwed together. When the cap 3 is further rotated, the outer cylinder side engaging portions 43 and 44 formed at the boundary between the nozzle portion 22 and the outer cylinder 21 and the cap side engaging portion formed near the rear end of the cap 55 and 56 are engaged and screwing is completed, the cap 3 is attached to the outer cylinder 2, and the marker 31 is in a predetermined position. In a state where the cap 3 is attached to the outer cylinder 2, the tip portion of the tip portion 24 is housed in the small diameter portion (tip portion tip portion storage portion) 52 of the cap 3, and is provided at the tip portion of the tip portion 24. The formed annular thick part 26 is stored in the tip storage part 52 in a liquid-tight and air-tight manner.

As shown in FIG. 1, the gasket 4 includes a main body portion extending at substantially the same outer diameter and a plurality of annular ribs provided on the main body portion (in this embodiment, if two or two or more, liquid tightness is provided. These ribs are in fluid-tight contact with the inner surface of the outer cylinder 2. Further, the tip surface of the gasket 4 has a shape corresponding to the shape of the inner surface of the distal end of the outer cylinder 2 so as not to form a gap as much as possible between the two when contacting the inner surface of the distal end of the outer cylinder 2.
The material for forming the gasket 4 includes elastic rubber (for example, butyl rubber, latex rubber, silicone rubber, styrene butadiene rubber), synthetic resin (for example, styrene elastomer such as SBS elastomer and SEBS elastomer, ethylene-α olefin copolymer). It is preferable to use an olefin elastomer such as a polymer elastomer).

The gasket 4 is provided with a recess extending inward from the rear end thereof, and this recess has a female screw shape, and is a male screw portion formed on the outer surface of the protruding portion formed at the distal end portion of the pusher 5. And can be screwed together. The pusher 5 is not detached from the gasket 4 by screwing them together. The pusher 5 may be removed and attached at the time of use.
As described above, the pusher 5 includes a protruding portion that protrudes in a cylindrical shape at the tip portion, and a male screw is formed on the outer surface of the protruding portion. Further, the pusher 5 includes a main body portion extending in the axial direction having a cross-shaped cross section, a pressing disk portion provided at the rear end portion, and a rib provided in the middle of the main body portion.
With the configuration as described above, the prefilled syringe injector 10 has a sealing property equivalent to that of a known cap in which the seal member is disposed, and therefore, it is possible to prevent deterioration of the chemical solution stored therein. Moreover, the chemical | medical solution inside a syringe does not leak outside.

Moreover, as a syringe, what is shown to FIG. 10 thru | or FIG. 12 may be used.
FIG. 10 is an enlarged cross-sectional view of the tip of a prefilled syringe according to another embodiment of the present invention. FIG. 11 is an enlarged view of the distal end portion of the outer cylinder used in the prefilled syringe shown in FIG. 12 is a plan view of an outer cylinder used in the prefilled syringe shown in FIG.
The difference between the syringe 100 of this embodiment and the above-described syringe 10 is that the outer cylinder 2 faces the portion where the marker 31 is located when the tip portion 24 is securely sealed by the tip portion storage portion 49. It is only a point provided with the 2nd marker 32 provided in the position. By providing such a second marker 32, it can be easily confirmed that the cap 3 is in a state of sealing the chip portion 24. Then, as shown in FIG. 12, it is preferable to provide two second markers 32 at opposite positions as in the first marker 31.
In this embodiment, the second marker 32 is a rib formed on the outer surface of the outer cylinder 2. However, the second marker 32 is not limited to this. For example, the second marker 32 is a recess formed on the outer surface of the outer cylinder. The coloring part formed in the outer surface of a pipe | tube, the magnetic index provided in the outer surface of the outer cylinder, etc. may be sufficient.

Next, the prefilled syringe using the prefilled syringe injector of the present invention will be described.
As shown in FIG. 1, the prefilled syringe is composed of the prefilled syringe syringe 10 (or the syringe 100) and the medicine 62 housed in the space formed by the outer cylinder 2, the gasket 4, and the cap 3. Become. As the drug 62, physiological saline, high-concentration sodium chloride injection, vitamins, minerals, heparin sodium aqueous solution and the like, and powdered or freeze-dried drugs such as antibiotics are used. The configuration of the prefilled syringe injector 10 is as described above.
With the configuration as described above, the prefilled syringe of the present invention has a sealing performance equivalent to that of a known cap in which the seal member is disposed, and therefore, deterioration of the chemical solution and the like stored therein is prevented. Moreover, the chemical | medical solution inside a syringe does not leak outside.
The syringe of the present invention can be applied not only to prefilled syringes but also to general syringes.

Next, the cap fitting state inspection method of the prefilled syringe of the present invention will be described using examples.
FIG. 14 and FIG. 15 are explanatory diagrams for explaining the cap fitting state inspection method of the prefilled syringe of the present invention.
The prefilled syringe cap fitting state inspection method of the present invention is detachable from the outer cylinder main body, an outer cylinder including a nozzle portion provided at the distal end portion of the outer cylinder main body portion, and having a distal end opened at the distal end. A syringe for a prefilled syringe comprising an attached or attachable cap 3, a gasket slidably accommodated in an outer cylinder, and a pusher attached or attachable to the rear end of the gasket, The nozzle portion includes an injection needle mounting tip portion that decreases in diameter toward the tip, and a nozzle-side threaded portion provided on the rear end side from the tip portion, and the cap stores the tip portion and the tip. A tip portion storage portion that seals the tip of the portion, a cap side screwing portion that fits into the nozzle side screwing portion, and a marker for confirming the fitting state between the cap and the tip portion, and , Ma Car, a rib formed on the cap interior surface, and, in which the drug inside the syringe is made to the prefilled syringe 1 filled.

As the prefilled syringe 1, the above-described syringe 1 or a prefilled syringe using the syringe 100 is an inspection target. For the details of the syringe, refer to the above description.
Then, in the inspection method, when the chip part is securely sealed by the chip part storage part, light is applied to the part from above the part where the marker 31 is located, and the chip part is stored by the chip part storage part. When the part is surely sealed, the marker 31 is optically confirmed from the side of the part where the marker 31 is located.
The cap fitting state inspection method applies light from above the portion where the marker 31 is located as described above, and the marker 31 is in a state where the tip portion is securely sealed by the tip portion storage portion. It is preferable that another light is applied from the back surface of the portion where is located. By doing in this way, the optical confirmation of the whole marker and cap part becomes easy.

And when the chip | tip part will be in the state sealed reliably by the chip | tip part accommodating part, the light source form of the light provided from the back surface of the site | part in which the marker 31 is located should be surface illumination wider than the whole cap 3. preferable. By doing in this way, the optical confirmation of the whole marker and cap part becomes easy.
In particular, the syringe to be inspected is preferably a rib formed on the inner surface at a position where the marker is near the opening end of the cap and slightly close to the opening end of the cap. In this cap fitting state inspection method, it is desirable that light is applied obliquely above the portion where the marker is located, and the marker position is confirmed using light collected by the rib forming the marker. By doing so, as shown in FIG. 17 and FIG. 18, a U-shaped condensed image that opens above the cap can be obtained on the marker 31, and optical confirmation of the marker becomes extremely easy. .

  In order to perform the cap fitting state inspection method, for example, an inspection system as shown in FIGS. 14 and 15 is used. In the inspection system of this embodiment, the first light source 80 for applying light to the prefilled syringe 1 from an obliquely upper part of the part where the marker will be located, and the part where the marker 31 of the cap 3 is located. A second light source 81 provided from the back surface and an image pickup means 82 disposed at a position facing the second light source 81 are provided. A prefilled syringe to be inspected is disposed between the imaging means 82 and the second light source 81. The imager 82 is connected to a determiner 83 for determining whether or not the marker is at a predetermined value from data based on the imaged result obtained by the imager.

  Then, as shown in FIG. 14, the prefilled syringe 1 sequentially and intermittently flows on the line 85 and temporarily stops at the point X. Then, the prefilled syringe stationary between the imaging unit 82 and the second light source 81 is irradiated with light from the first light source 80 and the second light source 81, and the image is captured by the imaging unit 82. Is done. Then, the imaging data is sent to the determiner 83, and it is determined whether or not the marker position is in the compatible range. In the system of this embodiment, if the determiner 83 determines that the marker is not in the appropriate position, the system includes means for removing the syringe from the line. In this embodiment, when the determiner 83 determines that the marker is not in the appropriate position, the device 84 is activated, the pressing means 86 is protruded from the device 84, and the prefilled syringe that is the object of inspection is pushed, Eliminate from line 85. Then, the line is activated again, and the next prefilled syringe inspection is started. The exclusion means may be located at any position on the line.

  Any imaging means may be used as long as it can receive light transmitted through the prefilled syringe to be inspected, but a charge coupled device (CCD) detector (CCD camera) is preferable. As such an imaging means, an area camera in which imaging points are two-dimensionally arranged and a linear camera in which imaging points are one-dimensionally arranged can be used. An area camera is particularly preferable. The light incident on the CCD camera is converted into an electrical signal corresponding to the intensity of the light, and the analog electrical signal is converted from analog to 8-bit analog-digital converter (A / D converter) to 256 gray levels. It will be converted into a digital output signal including it. Then, in the determination device, the captured image signal is divided into two or more regions, and the image data subjected to gray processing in each region is subdivided into element sizes having an appropriate number of pixels, and the image data is increased depending on the light intensity. The hierarchies are divided into stages, and the hierarchies are compared with each adjacent element in each region, and whether or not the marker is at a predetermined position is determined from the difference.

  The determination as to whether or not the marker 31 is at a predetermined value is made, for example, as shown in FIG. By using an apparatus as shown in FIGS. 14 and 15, captured images as shown in FIGS. 17 and 18 are obtained. When the marker is in the fitting position, that is, when the cap is in a good fitting state, an image is obtained in which the marker as shown in FIG. On the other hand, when the fitting is poor, imaging with the marker displaced by a predetermined distance or more from the center of the cap as shown in FIG. 18 is obtained. Further, in the syringe of this embodiment, since two markers are provided at positions facing each other, imaging similar to FIG. 17 can be obtained even when rotation by 180 degrees is insufficient, but the lower end of the cap (open end 3a) ) Is located above the normal state (FIG. 17). Therefore, as shown in FIG. 16, the determiner detects a marker from the captured image and calculates a distance w between the center line A of the cap and the center line of the marker B. Further, the lower end position of the cap is detected, and the height difference h from the shoulder portion of the outer cylinder is calculated. If the calculated distance w and height difference h exceed the allowable range, it is determined that the fitting is defective.

FIG. 1 is a partially broken front view of a prefilled syringe using a prefilled syringe injector according to an embodiment of the present invention. FIG. 2 is an enlarged cross-sectional view of the distal end portion of the prefilled syringe shown in FIG. FIG. 3 is an enlarged view of the distal end portion of the outer cylinder used in the prefilled syringe injector of the present invention. 4 is a longitudinal sectional view of the outer cylinder shown in FIG. FIG. 5 is a plan view of the outer cylinder shown in FIG. FIG. 6 is a front view of a cap used in the prefilled syringe of the present invention. 7 is a bottom view of the cap shown in FIG. FIG. 8 is a plan view of the cap shown in FIG. 9 is a cross-sectional view taken along line AA in FIG. FIG. 10 is an enlarged cross-sectional view of the tip of a prefilled syringe according to another embodiment of the present invention. FIG. 11 is an enlarged view of the distal end portion of the outer cylinder used in the prefilled syringe shown in FIG. 12 is a plan view of an outer cylinder used in the prefilled syringe shown in FIG. FIG. 13 is an enlarged view of the vicinity of the marker of the prefilled syringe according to the embodiment of the present invention. FIG. 14 is an explanatory diagram for explaining a cap fitting state inspection method for a prefilled syringe of the present invention. FIG. 15 is an explanatory view for explaining the cap fitting state inspection method for the prefilled syringe of the present invention. FIG. 16 is an explanatory diagram for explaining a fitting state pass / fail determination method in the prefilled syringe cap fitting state inspection method of the present invention. FIG. 17 is a diagram illustrating a captured image of the syringe obtained when the cap fitting state is good. FIG. 18 is a diagram illustrating a captured image of the syringe obtained when the cap fitting state is poor.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Prefilled syringe 2 Outer cylinder 3 Cap 4 Gasket 5 Pusher 22 Nozzle part 25 Nozzle side screwing part 26 Thick part 29 Tip opening 31 Marker 32 Second marker 49 Storage part 50 Cap side screwing part 52 Tip part tip part Storage part 58 Sealing part

Claims (16)

An outer cylinder body, an outer cylinder including a nozzle portion provided at a distal end portion of the outer cylinder body portion and having an opening at the distal end; a cap detachably attached to or attachable to the nozzle portion; A syringe for a prefilled syringe comprising a gasket slidably housed in a slidable portion and a pusher attached to or attachable to the rear end of the gasket,
The nozzle portion includes a tip portion for mounting an injection needle that decreases in diameter toward the tip, and a nozzle side screwing portion provided on the rear end side from the tip portion,
The cap includes the tip portion housing portion that houses the tip portion and seals the tip portion of the tip portion, the cap side screwing portion that is screwed with the nozzle side screwing portion, and the tip portion housing portion. A syringe for prefilled syringes, comprising: a marker for confirming a fitting state between the nozzle side screwing part and the cap side screwing part in which the tip part is surely sealed. The said outer cylinder is provided with the 2nd marker provided in the position facing the location where the said marker is located, when the said chip part will be in the state sealed reliably by the said chip part accommodating part. The syringe for prefilled syringes described in 1. The outer cylinder includes an outer cylinder side engaging portion provided on a rear end side with respect to the outer cylinder side screwing portion, and the cap is provided on an opening end side of the cap with respect to the cap side screwing portion. And a cap side engaging portion that engages with the outer cylinder side engaging portion, and in a state where the outer cylinder side engaging portion and the cap side engaging portion are engaged, The syringe for a prefilled syringe according to claim 1 or 2, which seals the tip portion. The cap includes a sealing portion that protrudes from the tip closing surface of the tip portion storage portion toward the opening end side, enters the tip opening of the tip portion and seals the tip opening, and further includes the tip portion storage. The portion includes a small-diameter portion that can be liquid-tightly contacted with the tip portion of the tip portion and that clamps the tip portion of the tip portion in cooperation with the sealing portion, and the tip portion storage portion The syringe for a prefilled syringe according to any one of claims 1 to 3, wherein the syringe has a shape that does not substantially contact the tip portion at a portion other than the small diameter portion. The syringe for a prefilled syringe according to claim 4, wherein the sealing portion of the cap has a free end and is reduced in diameter toward the free end. The prefilled syringe according to any one of claims 1 to 5, wherein the marker is a rib formed on an inner surface at a position near the open end of the cap and slightly closer to the closed end side than the open end of the cap. Syringe. The marker is a rib formed near the open end of the cap and on an inner surface at a position slightly closer to the closed end side than the open end of the cap, and the rib is slightly closed from the open end of the cap. A smooth bottom surface portion provided at a position on the end side, a smooth side surface portion extending from both ends of the smooth bottom surface portion to the closed end side of the cap, and an inner surface portion surrounded by the smooth bottom surface portion and the smooth side surface portion. The syringe for a prefilled syringe according to any one of claims 1 to 6, wherein a corner portion between the inner surface portion and the smooth bottom surface portion has a sharp edge. The syringe for a prefilled syringe according to claim 7, wherein the rib has a sharp edge at a corner between the inner surface portion and the smooth side surface portion. The syringe for a prefilled syringe according to claim 7 or 8, wherein the cap is formed of a material in which a clear shading change is caused by light reflected by the rib. The syringe for a prefilled syringe according to any one of claims 1 to 9, wherein the cap is made of a highly transparent material. A prefilled syringe comprising the syringe for prefilled syringe according to any one of claims 1 to 10, and a medicine accommodated in a space formed by the outer cylinder, the gasket, and the cap. The prefilled syringe according to claim 11, wherein the prefilled syringe is subjected to high-pressure steam sterilization. An outer cylinder including an outer cylinder main body, a nozzle provided at a distal end of the outer cylinder main body and having a nozzle opening; a cap detachably attached to or attachable to the nozzle; and the outer cylinder A syringe for a prefilled syringe comprising a gasket slidably accommodated therein and a pusher attached to or attached to the rear end of the gasket, wherein the nozzle portion is reduced in diameter toward the tip. A tip part for mounting the injection needle and a nozzle side screwing part provided on the rear end side from the tip part, and the cap houses the tip part and seals the tip part of the tip part A portion storage portion, a cap side screwing portion screwed with the nozzle side screwing portion, and a marker for confirming a fitting state of the cap side screwing portion and the nozzle side screwing portion. And within Agent is a cap fitted state inspection method of pre-filled syringe which has been filled in,
The marker is a rib formed on the inner surface of the cap, and the inspection method is performed at a position where the marker is located when the tip portion is securely sealed by the tip portion storage portion. Light is applied from above the part where the marker is located, and the marker is confirmed from the part where the marker is located when the tip part is securely sealed by the tip part storage part. A method for inspecting a cap fitting state of a prefilled syringe, characterized in that: The marker is a rib formed near the opening end of the cap and on the inner surface at a position slightly closer to the closed end side than the opening end of the cap, and the cap fitting state inspection method of the prefilled syringe is: The pre-filled syringe cap fitting according to claim 13, wherein light is applied obliquely above a portion where the marker is located, and the marker position is confirmed using light collected by a rib forming the marker. Condition inspection method. The prefilled syringe cap fitting state inspection method applies light from above the portion where the marker is located, and when the tip portion is securely sealed by the tip portion storage portion, the marker The method for inspecting a cap-fitted state of a prefilled syringe according to claim 13 or 14, wherein light is applied from a back surface of a site where the is located. The light source form of light applied from the back surface of the portion where the marker is located when the tip portion is surely sealed by the tip portion storage portion is surface illumination wider than the entire cap. 15. The prefilled syringe cap fitting state inspection method according to 15.