JP5394183B2 - Prefilled syringe - Google Patents

Description

  The present invention relates to a prefilled syringe prefilled with a chemical solution.

More syringes have been used than ever before, and recently, there are many cases that are used by being attached to a syringe pump. In addition, prefilled syringes pre-filled with a chemical solution have been widely used in recent years, and there are cases in which this prefilled syringe is also mounted on a syringe pump.
In the prefilled syringe, the gasket is inserted in a state where the medicine is filled in the outer cylinder whose tip opening is sealed, and the gasket is placed in the opening of the outer cylinder in an atmosphere under reduced pressure (vacuum atmosphere). It is common to use a so-called vacuum plugging method in which the gasket is inserted into the outer cylinder by setting the state. When the plunger is already mounted, it is difficult to dispose the gasket in the opening of the outer cylinder, and thus the above-described plugging operation is performed with the gasket alone. For this reason, as a prefilled syringe, it is common to require a subsequent plunger mounting operation. And, in order to make the plunger mounting operation to the gasket easy, and to prevent the occurrence of liquid leakage during the mounting operation and to suppress the increase in the internal pressure, the plunger is provided with a male screw portion, and the gasket is provided with a female screw portion. What has the mounting mechanism by both screwing is common.

  And as above-mentioned, a syringe and a prefilled syringe may be mounted | worn with a syringe pump and may be administered. When a syringe pump is used, a minute amount of continuous administration is performed. However, when the syringe pump is located higher than the patient, there is a possibility that a drug solution may be rapidly administered due to a drop. That is, in such a state, the drop causes the inside of the syringe to be in a negative pressure state, the gasket is sucked forward of the outer cylinder, and the pressing means of the syringe pump fixed to the plunger moves the gasket along with the suction. It is intended to administer a minute amount of continuous administration while preventing this. However, if the negative pressure overcomes the engagement force between the plunger and the gasket, there is a risk that the gasket will be detached from the plunger, and when the gasket is detached, the medicine in the syringe is rapidly administered.

And as what has a gasket detachment prevention mechanism, JP, 2002-272743, A (patent documents 1), JP, 2009-142508, A (patent documents 2), and international publication WO01-97885 (patent documents 3). JP, 2007-202822, A (patent documents 4). Patent Documents 1 to 3 are proposals of the applicant of the present application.
There have also been proposed gaskets comprising a gasket body and a plunger mounting member. For example, Japanese Utility Model Laid-Open No. 6-39005 (Patent Document 5), Japanese Patent Application Laid-Open No. 2007-44159 (Patent Document 6), No. 2008-307237 (Patent Document 7) and Japanese Patent No. 3665646 (Patent Document 8).

The syringe 1 of Patent Document 1 (Japanese Patent Laid-Open No. 2002-272843) is inserted through the outer cylinder 2, the gasket 3 that can slide in the outer cylinder 2, and the proximal end opening of the outer cylinder 2, and moves the gasket 3. And a plunger 4 to be operated. In a space surrounded by the outer cylinder 2 and the gasket 3, a liquid 7 is stored in advance in a liquid-tight manner. A flange portion 44 is formed on the head portion 43 at the distal end portion of the plunger 4. The gasket 3 has a hollow portion 33, and a screw thread 34 is formed on the inner surface on the proximal end side. Further, a space 35 in which the flange 44 is accommodated is formed on the tip side of the thread 34. The flange 44 that has passed through the thread 34 and entered the space 35 is engaged with the space 35 in a loosely fitted state.
In this syringe, the flange 44 formed on the head 43 at the tip of the plunger 4 is not threaded, so it is attached to the syringe pump and, as described above, the syringe pump is higher than the patient. When administered at the position, the plunger may be detached from the gasket.
A syringe 10 of Patent Document 2 (Japanese Patent Laid-Open No. 2009-142508) includes a gasket 3, an outer cylinder 2, and a plunger 4. The plunger 4 includes a spiral rib 44 provided on the outer surface of the head portion 42, and the gasket includes a spiral screw portion 33 for screwing with the spiral rib, and the vicinity of the spiral screw portion 33. In addition, a plunger retaining annular rib 34 located on the distal end side and a helical rib forming portion storage portion 32 of the plunger head portion are provided. The annular rib 34 includes a rib deficient portion 35 for guiding the helical rib that has reached the annular rib to the storage portion by the progress of the screwing of the helical rib of the plunger and the helical screwing portion of the gasket. .
This syringe is effective for preventing the plunger from coming off. However, depending on the manner in which the plunger is mounted, a mounting failure may rarely occur.

In the syringe of Patent Document 3 (International Publication WO01-97885), a head portion (connecting portion) 43 that is inserted into the hollow portion 33 of the gasket 3 and connected to the gasket 3 is formed at the distal end portion of the plunger 4. ing. A male screw 51 is formed on the outer peripheral surface of the head portion 43. On the other hand, a female screw 52 that can be screwed with the male screw 51 is formed on the inner peripheral surface of the hollow portion 33 of the gasket 3. The head portion 43 includes an elastic piece 61 disposed on the tip side from the male screw 51 and a protrusion 62 formed in the vicinity of the end portion of each elastic piece 61 so as to protrude in the outer peripheral direction. A ring-shaped engagement protrusion 63 is formed to protrude from the inner peripheral surface on the distal end side by the female screw 52 of the hollow portion 33 of the gasket 3.
This syringe is also mounted on the gasket by rotating the plunger, and a rotating operation is required for mounting the plunger. Furthermore, there is a case where the screwing is not properly performed, and in this state, the gasket outer surface is not a perfect circle, and liquid leakage may be caused. In addition, the stress when the mounted plunger is tilted is directly transmitted to the gasket, which may cause liquid leakage.
The plunger used for the syringe of patent document 4 (Unexamined-Japanese-Patent No. 2007-202822) contains the plunger rod 22 and the gasket 21, and the gasket 21 is provided with the inner space where the front-end | tip obstruct | occluded, and inner space is located in the base end. When the plunger rod 22 has a male screw-like protrusion 223 formed at the tip thereof and the protrusion 223 enters the inner space beyond the opening 212, the gasket 21 is formed. And the plunger rod 22 are engaged with each other in a loosely fitted state.
The “small-diameter opening” of this syringe not only “not screw-like”, but also prevents it from falling off when the plunger is pulled in the proximal direction, in addition to its function as a fall-off prevention rib due to reverse rotation. Because it is necessary, it is necessary to have higher strength. For this reason, if not properly screwed, the roundness of the outer surface of the gasket may be lowered and liquid leakage may occur when the female threaded protrusion of the gasket is twisted and screwed.
In Patent Document 5 (Japanese Utility Model Laid-Open No. 6-39005), a synthetic resin reinforcing material 30 is fitted into an inner chamber portion of a rubber plunger 20 that is tightly fitted into the syringe 2 of the syringe serving as a container. This reinforcing material 30 reinforces the peripheral wall portion 23 that forms the inner chamber portion of the plunger 20. The plunger rod 10 is detachably attached to the reinforcing material 30. The insertion portion 16 of the plunger rod 10 is inserted from the insertion hole 34 (see FIG. 2) provided in the lid portion 32 of the reinforcing member 30, and the plunger rod 10 is rotated so that the blade plate 17 included in the insertion portion 16 of the plunger rod 10. The opposing rod 18 is fitted into a fitting groove 36 (see FIG. 3) on the back surface 32 of the lid portion 32 of the reinforcing member 30, whereby the plunger rod 10 to the plunger 20 into which the reinforcing member 30 is fitted. Installation is complete.
With this syringe, during the mounting operation, the blade plate must be aligned with the slit-like fitting groove, and the plunger rod becomes in the way and cannot be visually observed. Therefore, the mounting operation is not easy. In addition, there is a risk that the plunger rod can be easily detached if the vane plate and the fitting groove are aligned after mounting.

A syringe 1 of Patent Document 6 (Japanese Patent Laid-Open No. 2007-44159) includes an outer cylinder 2, a gasket 3 that can slide within the outer cylinder 2, and a plunger 4 that moves the gasket 3. The gasket 3 and the plunger 4 are connected by a connecting mechanism. The plunger 4 engages the upper plunger 41 and the lower plunger 42. At this time, the convex portion 422 provided on the plunger lower portion 42 is inserted into the concave portion 412 provided on the plunger upper portion 41, and when the insertion is completed, the convex portion 422 provided on the plunger lower portion 42 is The lower plunger 42 is rotated until it is located at the end. Here, a clearance is provided between the engaging portions of the plunger upper 41 and the plunger lower 42, and they are engaged in a loose state. This syringe also requires a rotating operation for mounting the plunger.
The prefilled syringe of Patent Document 7 (Japanese Patent Laid-Open No. 2008-307237) is a prefilled syringe in which a chemical solution is filled and a gasket is stoppered. A bottom rod connected from the base end side, a stopper formed on the coupler, and an engaging portion formed on the bottom rod that engages with the stopper by rotation in the screwing direction of the bottom rod; The stopper is elastically deformed and does not engage with the engaging portion when it comes into contact with the engaging portion from the anti-screwing direction.
Also in this syringe, as in Patent Document 6, the mounting operation is not easy.

1 to 6 of Patent Document 8 (Japanese Patent No. 3665646) is a syringe including a barrel, a plunger, and a plunger rod, and when the plunger rod is driven, axial tension is applied to the plunger. Resulting in a reduction in the diameter of the plunger, which reduces the friction between the inside of the barrel and the plunger while limiting the extension of the plunger so that the seal between the inside of the barrel and the plunger is maintained, The plunger rod includes a rod member and a plunger coupling member, and the rod member is slidable in an axial direction with respect to the coupling member. 1 to 6 of Patent Document 7, the plunger insertion portion 68 has a female screw 69 that engages with the male screw 71 of the plunger rod 50, and the plunger rod 50 is connected to the plunger insertion portion 68. It has a male thread 71 designed to engage a female thread 69. This syringe also requires a rotating operation for mounting the plunger. Further, the syringe of the embodiment shown in FIGS. 7 to 18 includes a semi-circular plunger rod tip 164 having a convex surface protruding in the direction of the plunger, and this tip 164 is formed in a cross-shaped slit shown in FIG. It must be inserted and then rotated. In this syringe, the mounting of the plunger requires a positioning and insertion operation into the slit of the tip 164 and a rotation operation. Moreover, as shown in FIG. 11, since the rod tip 164 contacts and deforms the plunger, there is a high possibility of liquid leakage.
Also in this syringe, as in Patent Documents 6 and 7, the mounting operation is not easy, and there is a risk that the plunger rod may be detached after mounting.

Japanese Patent Laid-Open No. 2002-272843 JP 2009-142508 A International Publication No. WO01-97885 JP 2007-202822 A Japanese Utility Model Publication No. 6-39005 Japanese Patent Laid-Open No. 2007-44159 JP 2008-307237 A Japanese Patent No. 3665646

  Therefore, the object of the present invention is to confirm that the plunger is attached to the gasket during the plunger attaching operation to the gasket, and to reliably suppress the detachment of the gasket from the plunger after the attachment. A prefilled syringe that hardly deforms the gasket even when the plunger is tilted is provided.

What achieves the above object is as follows.
(1) An outer cylinder, a gasket that is slidably accommodated in the outer cylinder, a sealing member that seals a distal end opening of the outer cylinder, and a medicine container that is formed in the outer cylinder A prefilled syringe body comprising a prefilled syringe body made of a stored medicine and a plunger that is attachable to the gasket and is in a non-attached state, wherein the gasket has a cylindrical shape whose front end is closed and whose rear end is open A gasket main body having a lumen extending from the rear end opening toward the front end side, and a plunger mounting member attached to the gasket main body. A main body portion having a distal end side flange portion capable of pressing the proximal end surface on the distal end side, a front end portion protruding forward from the main body portion and capable of being stored in the lumen portion of the gasket main body, A helical rib provided on the outer surface of the distal end, a proximal flange provided on the proximal side of the main body, and a mounting member side slide engaging part provided on the proximal flange The gasket body is provided on the inner surface of the lumen portion, and is a helical screw portion for screwing with the helical rib of the plunger mounting member, and the helical shape of the lumen portion. And a storage portion for storing the distal end side from the spiral rib forming portion of the plunger mounting member, the plunger being mounted on the gasket when the plunger is mounted on the gasket. The mounting member-side slide engagement device includes a pressing portion capable of pressing the proximal end flange portion of the mounting member, and a plunger-side slide engagement portion for engaging with the mounting member-side slide engagement portion. Joint and the plunger The slide engaging portion is a portion in which the distal end portion of the plunger is slid in the lateral direction with respect to the axial direction of the prefilled syringe body on the proximal end flange portion of the plunger mounting member. And the fitting member side slide engagement part and the plunger side slide engagement part are fitted by the progress of the engagement of both, and the fitting for preventing the detachment of the plunger from the plunger fitting member And one of the mounting member side slide engaging portion and the plunger side slide engaging portion includes a holding portion and an extending portion extending in a sliding direction from an end portion of the holding portion, A male engagement portion including a first fitting portion provided in the extension portion, the other being provided on a storage portion capable of storing the extension portion and on an outer surface or inside of an end portion of the storage portion. Said first A female-side engaging portion having a second fitting portion that fits into the mating portion; and the male-side engaging portion is formed from the holding portion and both side portions of the end portion of the holding portion. Two extending portions extending so as to face each other, and a tip portion of the extending portion is a claw portion having a fitting portion, and the plunger mounting member is formed with the helical rib on the gasket body. A prefilled syringe that is mounted in a state in which the distal end side is housed in the housing portion from a site, and the distal end of the plunger mounting member does not contact the inner surface of the gasket body.
(2) an outer cylinder, a gasket that is slidably accommodated in the outer cylinder, a sealing member that seals a distal end opening of the outer cylinder, and a medicine accommodating portion that is formed in the outer cylinder. A prefilled syringe body comprising a prefilled syringe body made of a stored medicine and a plunger that is attachable to the gasket and is in a non-attached state, wherein the gasket has a cylindrical shape whose front end is closed and whose rear end is open A gasket main body having a lumen extending from the rear end opening toward the front end side, and a plunger mounting member attached to the gasket main body. A main body portion having a distal end side flange portion capable of pressing the proximal end surface on the distal end side, a front end portion protruding forward from the main body portion and capable of being stored in the lumen portion of the gasket main body, A spiral rib provided on the outer surface of the distal end portion, a proximal end flange portion provided on the proximal end side of the main body portion, and a mounting member side slide engagement portion provided on the proximal end flange portion; The gasket body is provided on the inner surface of the lumen portion, and is a helical screw portion for screwing with the helical rib of the plunger mounting member, and the helical screw of the lumen portion. And a storage portion for storing the distal end side from the spiral rib forming portion of the plunger mounting member, and the plunger is mounted on the gasket when mounted on the gasket. A pressing portion capable of pressing the base end side flange portion of the member for use, and a plunger side slide engaging portion for engaging with the mounting member side slide engaging portion, the mounting member side slide engaging Part and plunger The slide engaging portion is a portion in which the distal end portion of the plunger is slid in the lateral direction with respect to the axial direction of the prefilled syringe body on the proximal end flange portion of the plunger mounting member. And the fitting member side slide engagement part and the plunger side slide engagement part are fitted by the progress of the engagement of both, and the fitting for preventing the detachment of the plunger from the plunger fitting member The mounting member side slide engaging portion includes a holding portion protruding from an outer surface of the proximal end flange portion, and extends from an end portion of the holding portion, and the proximal end flange portion A male engagement portion having an extension portion spaced apart from the outer surface and extending substantially parallel to the outer surface, and a first fitting portion provided on the extension portion, wherein the plunger includes the plunger A head portion having a side slide engagement portion, wherein the plunger side slide engagement portion includes a storage portion capable of storing the extension portion, and the first fitting provided on an outer surface or inside of the end portion of the storage portion. A female engagement portion having a second fitting portion that engages with the mating portion, and a distal end surface of the head portion constitutes a pressing portion capable of pressing the proximal flange portion, and the plunger is mounted The member is mounted on the gasket body in a state where the distal end side is stored in the storage portion from the spiral rib forming portion, and the distal end of the plunger mounting member does not contact the inner surface of the gasket body. Prefilled syringe.
(3) an outer cylinder, a gasket that is slidably accommodated in the outer cylinder, a sealing member that seals a distal end opening of the outer cylinder, and a medicine container that is formed in the outer cylinder. A prefilled syringe body comprising a prefilled syringe body made of a stored medicine and a plunger that is attachable to the gasket and is in a non-attached state, wherein the gasket has a cylindrical shape whose front end is closed and whose rear end is open A gasket main body having a lumen extending from the rear end opening toward the front end side, and a plunger mounting member attached to the gasket main body. A main body portion having a distal end side flange portion capable of pressing the proximal end surface on the distal end side, a front end portion protruding forward from the main body portion and capable of being stored in the lumen portion of the gasket main body, A helical rib provided on the outer surface of the distal end, a proximal flange provided on the proximal side of the main body, and a mounting member side slide engaging part provided on the proximal flange The gasket body is provided on the inner surface of the lumen portion, and is a helical screw portion for screwing with the helical rib of the plunger mounting member, and the helical shape of the lumen portion. And a storage portion for storing the distal end side from the spiral rib forming portion of the plunger mounting member, the plunger being mounted on the gasket when the plunger is mounted on the gasket. The mounting member-side slide engagement device includes a pressing portion capable of pressing the proximal end flange portion of the mounting member, and a plunger-side slide engagement portion for engaging with the mounting member-side slide engagement portion. Joint and the plunger The slide engaging portion is a portion in which the distal end portion of the plunger is slid in the lateral direction with respect to the axial direction of the prefilled syringe body on the proximal end flange portion of the plunger mounting member. And the fitting member side slide engagement part and the plunger side slide engagement part are fitted by the progress of the engagement of both, and the fitting for preventing the detachment of the plunger from the plunger fitting member The plunger includes a front end side flange portion, a holding portion provided on an outer surface of the front end side flange portion, and an outer surface of the front end side flange portion extending from an end portion of the holding portion. A male-side engagement portion having an extension portion that is spaced apart from and extends substantially parallel to the outer surface, and a first fitting portion provided on the extension portion, and the mounting member-side slide engagement Is provided on the base end flange portion, and engages with a storage portion capable of storing the extension portion and a first fitting portion provided on the outer surface or inside of the end portion of the storage portion. A female side engaging portion having a fitting portion, wherein the distal end flange portion of the plunger constitutes a pressing portion that presses the proximal end flange portion of the plunger mounting member, and the plunger mounting The member is mounted on the gasket body in a state where the distal end side is stored in the storage portion from the spiral rib forming portion, and the distal end of the plunger mounting member does not contact the inner surface of the gasket body. Prefilled syringe.

( 4 ) The male side engaging portion includes the holding portion and the two extending portions extending so as to face the both side portions of the end portion of the holding portion, and the distal end portion of the extending portion is fitted. The prefilled syringe according to the above (2) or (3) , which is a nail portion having a portion.
( 5 ) The storage portion of the female engagement portion can store the extension portion of the male engagement portion in a state where the fitting portion of the claw portion protrudes, and the claw The prefilled syringe according to ( 4 ) above, wherein the fitting portion of the portion is fitted to the outer end surface of the storage portion when protruding from the storage portion.
( 6 ) The said female side engaging part is provided with the guide part for guide | inducing the said male side engaging part in the one end side opening and / or other end side opening of the said accommodating part ( 1 ) thru | or ( The prefilled syringe according to any one of 5 ).
( 7 ) The gasket main body includes a plunger retaining annular rib located near and on the tip side of the helical threaded portion, and the annular rib is the helical rib of the main body portion of the plunger mounting member. (1) to ( 6 ) further including a guide portion for guiding the spiral rib that has reached the annular rib to the storage portion by the progress of screwing with the spiral threaded portion of the gasket body. The prefilled syringe according to any one of the above.
( 8 ) The prefilled syringe according to ( 7 ), wherein the annular rib is gradually reduced toward the guide portion.

The prefilled syringe of the present invention is housed in an outer cylinder, a gasket housed in the outer cylinder, a sealing member for sealing the distal end opening of the outer cylinder, and a medicine container formed in the outer cylinder. It consists of a prefilled syringe body made of a medicine and a plunger that can be attached to the gasket and is not attached. The gasket is a cylindrical body whose front end is closed and whose rear end is open, and which includes a gasket body provided with a lumen extending from the rear end opening to the front end side, and a plunger mounting member attached to the gasket body. Become. The plunger mounting member is provided on a main body portion having a front end flange portion capable of pressing the proximal end surface of the gasket main body on the front end side, a front end portion that can be stored in a lumen portion of the gasket main body, and an outer surface of the front end portion. A helical rib; and a mounting member side slide engagement portion provided on a proximal flange portion provided on a proximal end side of the main body portion. The gasket body includes a helical threaded portion for screwing with the helical rib of the plunger mounting member, and a storage portion for storing the distal end side from the helical rib forming portion of the plunger mounting member. The plunger includes a pressing portion that can press the proximal end flange portion of the plunger mounting member, and a plunger side slide engaging portion for engaging with the mounting member side slide engaging portion. The mounting-member-side slide engagement portion and the plunger-side slide engagement portion are formed by sliding the distal end portion of the plunger laterally with respect to the prefilled syringe body axial direction on the proximal-end flange portion of the plunger mounting member, Both are engaged, and the mounting-member-side slide engaging portion and the plunger-side slide engaging portion are engaged with each other as the engagement proceeds, and the plunger is detached from the plunger mounting member. A fitting mechanism is provided to prevent this. The plunger mounting member is mounted on the gasket body in a state where the distal end side is stored in the storage portion from the spiral rib forming portion, and the distal end of the plunger mounting member is not in contact with the inner surface of the gasket body. ing.
In the prefilled syringe of the present invention, since the plunger can be attached to the gasket by a sliding operation, there is no sense of incongruity in operation compared to the concave and convex fitting type. Further, in the case of the concave-convex fitting method, there is a tendency to strongly grip the side portion of the outer cylinder in order to resist shock at the time of fitting, which causes deformation of the outer cylinder and causes liquid leakage. However, the prefilled syringe of the present invention does not cause liquid leakage due to compression during the operation of the outer cylinder.
Further, in the prefilled syringe of the present invention, the plunger is mounted on the plunger mounting member by sliding in the lateral direction with respect to the axial direction of the prefilled syringe body instead of the longitudinal direction as the gasket traveling direction. The plunger mounting member does not rotate during the mounting operation, and no liquid leakage occurs during the mounting operation. Also. At the time of the mounting operation, the sliding operation for mounting can be easily confirmed by the fitting mechanism engaging with the progress of the engagement between the two. Further, even if the mounted plunger is rotated, the rotational force is transmitted to the plunger mounting member but is not transmitted to the gasket body, and the gasket is not deformed. Further, since the gasket body and the plunger mounting member are substantially loosely fitted, the gasket is not deformed even when the plunger is tilted, and liquid leakage is unlikely to occur.

FIG. 1 is a front view of a prefilled syringe according to an embodiment of the present invention. FIG. 2 is a longitudinal sectional view of a prefilled syringe body of the prefilled syringe shown in FIG. FIG. 3 is an enlarged front view of a gasket used in the prefilled syringe of the present invention. 4 is a longitudinal sectional view of the gasket shown in FIG. FIG. 5 is a cross-sectional view of a gasket body used in the gasket shown in FIG. 6 is a cross-sectional view taken along line AA in FIG. FIG. 7 is a left side view of a plunger mounting member used in the gasket shown in FIG. FIG. 8 is a plan view of the plunger mounting member shown in FIG. 9 is a bottom view of the plunger mounting member shown in FIG. 10 is a cross-sectional view taken along line BB in FIG. FIG. 11 is a perspective view of the plunger mounting member shown in FIG. 7 as viewed from the bottom side. FIG. 12 is an enlarged front view of a plunger used in the prefilled syringe of the present invention. FIG. 13 is a perspective view of the plunger of FIG. FIG. 14 is an enlarged plan view of the plunger shown in FIG. FIG. 15 is an enlarged cross-sectional view of the tip side portion of the plunger shown in FIG. FIG. 16 is an explanatory diagram for explaining an engagement state between the plunger mounting member and the plunger. FIG. 17 is a front view of an outer cylinder used in the prefilled syringe of the present invention. FIG. 18 is a cross-sectional view of a sealing member (seal cap) used in the prefilled syringe of the present invention. FIG. 19 is a perspective view of a plunger mounting member and a plunger used in a prefilled syringe according to another embodiment of the present invention. FIG. 20 is an explanatory diagram for explaining the operation when the prefilled syringe body and the plunger are mounted in the prefilled syringe of the present invention. FIG. 21 is an explanatory diagram for explaining the operation when the prefilled syringe body and the plunger are mounted in the prefilled syringe of the present invention. FIG. 22 is an explanatory diagram for explaining the operation when the prefilled syringe body and the plunger are mounted in the prefilled syringe of the present invention.

Hereinafter, the prefilled syringe of the present invention will be described.
The prefilled syringe 1 of the present invention includes an outer cylinder 2, a gasket 3 slidably accommodated in the outer cylinder 2, a sealing member 5 that seals the distal end opening of the outer cylinder 2, and an inner cylinder 2 The prefilled syringe main body 10 which consists of the chemical | medical agent 8 accommodated in the chemical | medical agent storage part formed in this, and the plunger 4 which can be mounted | worn with the gasket 3 and is a non-mounting state.
The gasket 3 is a cylindrical body whose front end is closed and whose rear end is open, and which has a lumen body 60 extending from the rear end opening to the front end side, and a plunger attached to the gasket main body 6 And a member 7 for use.
The plunger mounting member 7 protrudes forward from the main body portion 70 having a distal end flange portion 72 capable of pressing the proximal end surface of the gasket main body 6 on the distal end side, and is housed in the inner cavity portion of the gasket main body 6. A possible distal end portion 71, a spiral rib 74 provided on the outer surface of the distal end portion 71, a proximal end flange portion 78 provided on the proximal end side of the main body portion 70, and a proximal end flange portion 78. The mounting member side slide engagement portion 75 is provided. The gasket main body 6 is provided on the inner surface of the lumen portion, and has a helical screw portion 63 for screwing with the helical rib 74 of the plunger mounting member 7, and a distal end from the helical screw portion 63 of the lumen portion. And a storage portion 62 for storing the tip side (in other words, the spiral rib forming portion portion and the tip side portion thereof) from the spiral rib forming portion of the tip portion 71 of the plunger mounting member 7.
When the plunger 4 is mounted on the gasket 3, the plunger side engages with the pressing member 42 that can press the proximal end flange portion 78 of the plunger mounting member 7 and the mounting member side slide engagement portion 75. And a slide engaging portion 40. The mounting member side slide engaging portion 75 and the plunger side slide engaging portion slide the distal end portion of the plunger 4 laterally with respect to the axial direction of the prefilled syringe body on the proximal end side flange portion 78 of the plunger mounting member 7. By doing so, both are engaged, and the mounting-member-side slide engaging portion 75 and the plunger-side slide engaging portion 40 are fitted by the progress of the engagement between them, and the plunger-mounting member 7 is provided with fitting mechanisms 43a and 76a for preventing the plunger 4 from being detached from the. The plunger mounting member 7 is mounted in a state where the gasket main body 6 stores the spiral rib 74 in the storage portion 62, and the tip of the plunger mounting member 7 does not contact the inner surface of the gasket main body 6. ing.

The prefilled syringe 1 of the present invention includes a prefilled syringe body 10 and a plunger 4 that can be attached to the prefilled syringe body 10 (gasket 3) and is not attached.
The prefilled syringe body 10 is formed in the outer cylinder 2, the sealing member 5 that seals the front end opening of the outer cylinder 2, the gasket 3 that is slidably accommodated in the outer cylinder, and the outer cylinder 2. And a medicine 8 stored in the medicine storage section.
The gasket 3 includes a gasket body 6 and a plunger mounting member 7 attached to the gasket body 6.
As shown in FIGS. 1 to 6, the gasket main body 6 is a cylindrical body having a closed front end and a lumen portion 60 extending to the front end side from the rear end opening. The gasket main body 6 has a taper portion 61 that decreases in diameter toward the tip side in a taper shape. Further, the gasket body 6 includes a front end side annular rib 68 provided on the front end side of the outer surface and a rear end side annular rib 69 provided on the rear end side.

  And the gasket main body 6 is provided with the lumen | bore part 60, and this lumen | bore part 60 is equipped with the attachment function of the member for plunger mounting | wearing. The inner cavity portion 60 has a helical screw portion 63 for screwing with the helical rib 74 of the plunger mounting member 7 on the inner surface thereof, and a distal end side of the plunger mounting member 7 with respect to the helical screw portion 63. A storage portion 62 for storing the spiral rib forming portion of the distal end portion 71 is provided. Further, in this embodiment, the gasket body 6 includes a plunger retaining annular rib 64 positioned near the distal end side of the spiral threaded portion 63, and the annular rib 64 further includes the distal end of the plunger mounting member 7. A guide portion 65 is provided for guiding the spiral rib 74 that has reached the annular rib 64 to the storage portion 62 by the progress of screwing between the spiral rib 74 of the portion 71 and the spiral screw portion 63 of the gasket body 6. ing. The guiding portion 65 is formed by a rib defect portion. In addition, a guide part is not limited to a rib defect | deletion part, A recessed part, a thin part, etc. may be sufficient, and also the cyclic | annular rib whole may be weak. In this embodiment, the storage portion 62 is provided on the tip side from the annular rib 64.

The spiral threaded portion 63 has a start end 63 a in the vicinity of the opening portion of the lumen portion 60, extends a predetermined length in the distal direction, and has a terminal end 63 b in the vicinity of the missing portion 65 of the annular rib 64.
In this embodiment, the helical threaded portions 63 are two (two) helically threaded portions 63 so as to correspond to spiral ribs 74 of the distal end portion 71 of the plunger mounting member 7 described later. ing. And in the gasket main body of this Example, in order to form two (2) helical screwing parts, as shown in FIG. 5 and FIG. 6, two helical protrusions 66a and 66b are provided. . In addition, although it is preferable to provide a plurality (specifically, two strips) of helical screw portions as described above, the spiral screw portion (spiral protrusion) may be only one (one). Good.
In this embodiment, the helical threaded portion 63 is a groove-like portion formed between the helical projections 66 projecting from the inner wall surface of the lumen portion 60 of the gasket body 6. The screwing portion 63 can be screwed with the spiral rib 74 of the plunger mounting member 7 and can guide the spiral rib in the distal direction. The spiral protrusion 66 has a starting end near the opening of the lumen 60, extends a predetermined length in the direction of the tip, and has a termination at a position slightly beyond the defect 65 of the annular rib 64.

The gasket body 6 includes a plunger retaining annular rib 64 provided on the inner surface of a portion located in the vicinity of the spiral threaded portion 63 and on the tip side of the spiral threaded portion 63. In the gasket of this embodiment, the annular rib 64 extends in a direction substantially orthogonal to the central axis of the gasket 3. The annular rib 64 desirably extends in a direction orthogonal to the central axis of the gasket 3, but may be slightly inclined from the orthogonal state.
Further, the gasket body 6 includes a storage portion 62 for storing the spiral rib forming portion of the tip portion 71 of the plunger mounting member 7 on the tip side of the annular rib 64.

Further, the annular rib 64 reaches the annular rib 64 by the progress of the screwing of the spiral rib 74 of the tip 71 of the plunger mounting member 7 and the spiral screw 63 of the gasket body 6. Is provided with a guiding portion (specifically, a missing portion of the annular rib) 65. In particular, in the gasket main body 6 of this embodiment, as described above, the helical threaded portion 63 is a double helical threaded portion corresponding to the two helical ribs, and corresponds to this. Further, as shown in FIG. 6, two annular ribs are provided at substantially opposite positions. In other words, as shown in FIG. 6, the gasket body 6 includes annular ribs 64 a and 64 b divided into two, and two missing portions 65 a and 65 b positioned between the two. Furthermore, as shown in FIG. 6, it is preferable that the ribs of the annular rib 64 (64a, 64b) gradually become smaller toward the defect portion 65 (65a, 65b). The ribs gradually narrow toward the defect portion 65 (65a, 65b), gradually decrease in height, and gradually decrease in width and gradually decrease in height. Any of those may be used.
By doing in this way, passage of the annular rib 64 of the spiral rib 74 of the plunger mounting member 7, in other words, entry into the storage portion 62 becomes easier. In addition, even if the rib of the said part does not completely lose | delete, the defect | deletion part should just be missing to the extent which has the function to guide | induc the helical rib of the member 7 for plunger mounting | wearing.

As shown in FIG. 5, the width of the spiral threaded portion 63, in other words, the distance between the spiral protrusion 66 and the annular rib 64 is directed toward the defect portion 65 (similarly, the spiral threaded portion 63. (Toward end 63b) becomes narrower. For this reason, the induction | guidance | derivation to the defect | deletion part 65 of the annular rib 64 of the helical rib 74 of the member 7 for plunger mounting is ensured. Moreover, it is preferable that the protruding height of the helical protrusion 66 for forming the helical threaded portion 63 of the gasket body 6 is higher than the protruding height of the annular rib 64.
And although the height of the annular rib 64 changes with the magnitude | sizes of a gasket main body, it is preferable that it is 1.0-3.0 mm, and 1.5-2.5 mm is especially preferable. Moreover, it is preferable that the width | variety (width | variety of the circumferential direction of a gasket) of the defect | deletion part 65 of the cyclic | annular rib 64 is 0.5-3.0 mm, and 0.5-1.5 mm is especially preferable.
Further, the gasket body 6 includes a protrusion 67 that protrudes toward the rear end at the center of the inner surface of the front end. The protrusion 67 may be capable of coming into contact with the distal end of the distal end portion 71 of the plunger mounting member 7 when the distal end portion of the gasket body 6 is deformed to the rear end side. The protrusion 67 is preferably substantially hemispherical. The gasket body 6 generally has a diameter of 5 to 30 mm and a total length of about 5 to 30 mm.

  As a constituent material of the gasket body 6, known materials that have been used for gaskets can be used. Examples thereof include rubber, elastomer, polyolefin resin, fluorine resin, and polyester resin. As the rubber, for example, natural rubber, isoprene rubber, butyl rubber, chloroprene rubber, nitrile-butadiene rubber, styrene-butadiene rubber, and silicone rubber are preferable, and vulcanized rubber is particularly preferable. As the elastomer, for example, a polyvinyl chloride elastomer, a polyolefin elastomer, a styrene elastomer, a polyester elastomer, a polyamide elastomer, a polyurethane elastomer, and a mixture thereof are preferable. Among the above rubbers and elastomers, styrene-butadiene rubber, butyl rubber, and styrene elastomers have suitable hardness and elastic properties, and various sterilization methods such as γ-ray sterilization, electron beam sterilization, and high-pressure steam sterilization can be adopted. Therefore, it is preferable.

Further, the gasket main body may be formed by coating the tip side portion with a low drug adsorbing substance or the like.
As the material for the low drug adsorbing layer, known materials conventionally used for laminate gaskets can be used. Examples of the material for the low drug adsorption layer include polyolefin resins, fluorine resins, and polyester resins. Specifically, the polyolefin resin is preferably polypropylene, ultrahigh molecular weight polyethylene, poly (4-methylpentene-1), cyclic polyolefin or the like, and the fluorine resin is tetrafluoroethylene-perfluoroethoxyethylene copolymer. Polymers, polytetrafluoroethylene, tetrafluoroethylene / perfluoroalkyl vinyl ether copolymers, tetrafluoroethylene / hexafluoropropylene copolymers and the like are preferable.
Further, it is preferable to apply a lubricant to the outer surface of the gasket body 6, at least the surfaces of the front end side annular rib 68 and the rear end side annular rib 69. The lubricant may be applied to the inner surface of the outer cylinder. Silicone oil is suitable as the lubricant. Alternatively, a silicone resin layer formed by solidifying on the surface of the gasket main body may be provided without using a lubricant such as silicone oil.

As shown in FIGS. 2 to 11, the plunger mounting member 7 includes a main body portion 70 that extends a predetermined length, a front end portion 71 that protrudes forward from the main body portion 70 and can be stored in the lumen portion of the gasket main body 6, and a main body. A proximal end flange portion 78 provided on the proximal end side of the portion 70, and a mounting member side slide engagement portion 75 provided on the proximal end flange portion 78.
The main body 70 has a cross-shaped cross section and extends a predetermined length, and includes a mounting member side slide engagement portion 75 at the base end thereof. For this reason, it can be performed while visually observing the mounting of the plunger mounting member and the plunger during the plunger mounting operation, and the mounting operation can be performed safely and reliably.
The main body portion 70 includes a reinforcing portion 73 on the proximal end side. Further, a disc-shaped distal end side flange portion 72 capable of pressing the proximal end surface of the gasket body 6 is provided at the distal end of the main body portion 70, and a disc shape capable of contacting the pressing portion 42 of the plunger 4 is provided at the proximal end. The proximal end side flange portion 78 is provided.
The outer flange 72 has a substantially circular outer edge, and the outer diameter is slightly smaller than the outer diameter of the base end of the gasket body 6. Moreover, the front end side peripheral part of the flange part 72 is a flat surface, and is in contact with the rear end surface of the gasket main body 6 so that it can be pressed.

The distal end portion 71 protruding from the main body portion 70 (specifically, the distal end side flange portion 72) is a cylindrical portion that extends at substantially the same outer diameter. The tip 71 is shorter than the main body 70. The distal end portion 71 projects forward from the vicinity of the center of the distal end side flange portion 72 of the main body portion 70. Further, the distal end portion 71 is not in contact with the inner surface of the distal end portion of the gasket body 6 in a normal state where the gasket body 6 is not deformed.
A spiral rib 74 is formed on the outer surface of the distal end portion of the distal end portion 71 of the plunger mounting member 7. Further, in the plunger mounting member 7 in this embodiment, as shown in FIGS. 4, 7, 8, 10, and 11, so as to correspond to the helical threaded portion 63 of the gasket body 6 described above, Two (two) spiral ribs 74 are formed. The spiral rib 74 has a start end near the tip end of the tip end portion 71 of the plunger mounting member 7 and extends toward the rear end side by a predetermined length. Although it is preferable to provide such a plurality (specifically, two strips) of spiral ribs, the spiral rib may be only one strip (one). Further, as shown in FIGS. 7 and 8, the spiral rib 74 includes a flat portion (a flat portion orthogonal to the central axis of the plunger mounting member) 74a at the start end portion.

The height of the annular rib of the gasket body and the height of the helical rib of the plunger mounting member are preferably as follows. The height of the annular rib of the gasket main body is preferably 1.0 to 3.0 mm, and particularly preferably 1.5 to 2.5 mm. The height of the helical rib of the plunger mounting member is preferably 2.5 to 3.2 mm, particularly preferably 2.8 to 3.1 mm, and more preferably 2.95 to 3.05 mm. And the width | variety of the contact part of a cyclic | annular rib and a helical rib is preferably 0.5-2.5 mm, and 1.0-2.3 mm is especially preferable. The inner diameter of the annular rib portion of the gasket body is preferably 16.0 to 20.0 mm, particularly preferably 17.0 to 19.0 mm, and the outer diameter of the helical rib portion of the plunger mounting member is 19.0 to 22.0 mm, particularly preferably 20.0 to 21.0 mm.
As a constituent material of the plunger mounting member 7, it is preferable to use a hard or semi-hard resin such as high-density polyethylene, polypropylene, polystyrene, or polyethylene terephthalate.

As shown in FIGS. 1 to 4 and 7 to 11, the plunger mounting member 7 includes a mounting member side slide engaging portion 75 provided at the base end portion. In this embodiment, the mounting member side slide engagement portion 75 protrudes from the outer surface of the proximal end flange portion 78.
In the syringe of this embodiment, one of the mounting member side slide engaging portion 75 and the plunger side slide engaging portion 40 is a holding portion 77 and an extending portion 76 extending in the sliding direction from the end portion of the holding portion 77; A male side engaging portion provided with a first fitting portion 76a provided in the extending portion 76, the other being a storage portion 43 capable of storing the extending portion 76 and an outer surface of the end portion or the inside of the storing portion 43. It has a female side engaging part which has the 2nd fitting part 43a engaged with the 1st fitting part 76a provided in this.
In particular, in the syringe 1 of this embodiment, as shown in FIGS. 1 to 16, the mounting member side slide engagement portion 75 includes a holding portion 77 that protrudes from the outer surface of the proximal end flange portion 78, and a holding portion 77. A first fitting provided on the extension portion 76, and an extension portion 76 that extends from the end portion of the base end flange portion and that is spaced apart from the outer surface of the base end side flange portion 78 and extends substantially parallel to the outer surface of the base end side flange portion 78. A male side engaging portion having a joint portion 76a is provided. Further, a gap 79 is formed between the outer surface of the proximal end side flange portion 78 and the extending portion 76.
As shown in FIGS. 1 to 4 and FIGS. 7 to 11, the plunger mounting member 7 of this embodiment has a proximal end side flange portion 78 and is located outward from a position slightly on the peripheral side from the center. A holding portion 77 is formed so as to protrude. The holding part 77 is substantially linear. An extending portion 76 that is spaced from the base end side flange portion 78 by a predetermined distance from the end portion of the holding portion 77 and extends substantially parallel to the base end side flange portion 78 is provided. The extending portion 76 is two extending portions that extend so as to face each other from both side portions of the end portion of the holding portion 77. Furthermore, as shown in FIG. 10, the base end part (boundary part with a holding | maintenance part) of the extension part 76 is thin, and enables the extension part to elastically deform. Moreover, the front-end | tip part of the two extension parts 76 curves so that it may mutually adjoin, and the nail | claw part is formed, and both the front-end | tips of the two extension parts 76 are the closest. Further, the two extending portions 76 can be elastically deformed inward (in the direction in which both are close to each other). Further, as described above, the distal end portion of the extending portion 76 is a claw portion, and a step portion is formed on the side portion thereof, and this step portion forms a fitting portion 76a. The height of the stepped portion is preferably about 0.2 to 1.2 mm. Further, the stepped portion is an upstanding surface with respect to the side surface of the extending portion 76. The distance between the extending portion 76 and the proximal end flange portion 78 (the height of the gap portion 79) is preferably about 1 to 3 mm.
Further, the plunger mounting member 7 of this embodiment includes a notch 81 at the side of the proximal end flange 78 as shown in FIGS. 9 and 11. Further, two notches 81 are provided so as to face each other. The mounting member-side slide engaging portion 75 (the holding portion 77 and the extending portion 76) described above is located at the center of the two cutout portions 81. Further, the extending portion 76 extends substantially in parallel with the two cutout portions 81. For this reason, the notch 81 is an indicator of the sliding direction for the engagement of the mounting member side slide engaging portion 75.

As shown in FIGS. 1 to 4, in the prefilled syringe of the present invention, a gasket 3 in which a plunger mounting member 7 is mounted on a gasket body 6 is housed in an outer cylinder 2. As shown in FIGS. 1 and 2, the base end of the plunger mounting member 7 is housed so that the mounting member side slide engaging portion 75 is exposed from the base end of the outer cylinder 2. The plunger mounting member 7 is mounted on the gasket body 6 as follows.
After inserting the helical rib 74 of the plunger mounting member 7 into the starting end of the helical threaded portion 63 of the gasket body 6, the plunger mounting member 7 is rotated to rotate the helical rib 74 and the helical threaded portion 63. The screwing proceeds. Due to the progress of the screwing, the starting end of the helical rib 74 of the plunger mounting member 7 approaches the terminal end of the helical screwing portion 63 of the gasket body 6 and the missing portion 65 of the annular rib 64, and the spiral of the plunger mounting member 7. The starting end of the rib 74 is located between the spiral protrusion 66 and the annular rib 64 that form the spiral threaded portion 63 of the gasket body 6. When the plunger mounting member 7 is further rotated, the spiral rib 74 passes through the missing portion 65 of the annular rib 64 and enters the storage portion 62, thereby continuing the rotation of the plunger mounting member 7. As shown in FIG. 4, the entire spiral rib 74 passes through the missing portion 65 of the annular rib 64, and the spiral rib forming portion of the distal end portion 71 of the plunger mounting member 7 is the storage portion of the gasket body 6. It will be in the state accommodated in 62. Thereby, the mounting operation of the plunger mounting member 7 to the gasket body 6 is completed. When the plunger mounting member 7 is mounted on the gasket body 6, the rear end surface of the helical rib 74 of the plunger mounting member 7 abuts on the front end surface of the annular rib 64 of the gasket body 6. The detachment of the member 7 from the gasket body 6 is restricted. Further, in the state where the spiral rib forming portion of the distal end portion 71 of the plunger mounting member 7 is stored in the storage portion 62 of the gasket main body 6, the plunger mounting member 7 is idled. Furthermore, the rear end of the spiral rib does not enter the defect portion 65 of the annular rib 64 regardless of which direction is rotated in the normal state, and the plunger mounting member 7 is rotated by the rotation of the plunger mounting member 7. And the rotation of the gasket body 6 are suppressed. The plunger mounting member 7 is mounted in a state where the gasket main body 6 stores the spiral rib 74 in the storage portion 62, and the tip of the plunger mounting member 7 does not contact the inner surface of the gasket main body 6.

As shown in FIGS. 1, 12 to 15, the plunger 4 includes a shaft portion 41 having a cross-shaped cross section, and a plunger side for engaging a mounting member side slide engagement portion 75 at the tip thereof. A slide engagement portion 40 is provided. A reinforcing rib 49 is provided in the middle of the shaft portion 41 , and a plunger pressing portion 47 is provided at the proximal end.
In the syringe of this embodiment, one of the mounting member side slide engaging portion 75 and the plunger side slide engaging portion 40 is a holding portion 77 and an extending portion 76 extending in the sliding direction from the end portion of the holding portion 77; A male side engaging portion provided with a first fitting portion 76a provided in the extending portion 76, the other being a storage portion 43 capable of storing the extending portion 76 and an outer surface of the end portion or the inside of the storing portion 43. It has a female side engaging part which has the 2nd fitting part 43a engaged with the 1st fitting part 76a provided in this.
In the syringe 1 of this embodiment, as described above, the mounting member side slide engaging portion of the plunger mounting member 7 is the male side engaging portion, and the plunger side slide engaging portion 40 of the plunger 4 is the female side engaging portion. It is a side engaging part. For this reason, the plunger 4 engages with the storage portion 43 that can store the extension portion 76 of the plunger mounting member 7 and the first fitting portion 76 a provided on the outer surface or inside of the end portion of the storage portion 43. The female side engaging part which has the two fitting parts 43a is provided.
As shown in FIGS. 12 to 16, the plunger 4 of this embodiment includes a head portion having a plunger-side slide engaging portion 40, and the plunger-side slide engaging portion 40 is a mounting member-side slide engaging portion 75. A storage portion 43 capable of storing the extended portion 76 and a second fitting portion 43a which is provided on the outer surface or inside of the end portion of the storage portion 43 and engages with the first fitting portion 76a of the extended portion 76. The female side engaging part which has is provided. In addition, the plunger 4 of this embodiment includes a pressing portion 42 that is formed by the outer surface of the storage portion 43 and that can press the proximal end flange portion 78 of the plunger mounting member 7. The pressing portion 42 has a flat outer surface, and can enter between the holding portion 77 and the extending portion 76 of the plunger mounting member 7. The thickness of the plate-like portion forming the pressing portion 42 is preferably slightly smaller than the distance between the extension portion 76 and the proximal end flange portion 78.

And the accommodating part 43 has a rectangular-shaped lumen | bore, and can accommodate the extension part 76 of the member 7 for plunger mounting | wearing inside. In particular, in this embodiment, as shown in FIG. 16, the storage portion 43 constituting the female side engaging portion is accommodated in a state in which the claw portion of the extending portion 76 constituting the male side engaging portion protrudes. The protrusion (first fitting portion) 76a of the claw portion is fitted with the outer end surface (second fitting portion) 43a of the storage portion 43 when protruding from the storage portion 43. It has become. In addition, it is not limited to such a thing, The 1st fitting part of a male type engaging part may engage in the inside of a female type engaging part (storage part). .
In the plunger 4 of this embodiment, the storage portion 43 has one end side opening, the other end side opening, and a lumen portion extending from the one end side opening to the other end side opening. And the extension part 76 of the member 7 for plunger mounting can enter from either one end side opening and the other end side opening. Further, in the plunger 4 of this embodiment, the female side engaging portion is guided to guide the male side engaging portion to the storage portion 43 in one or both of the one end side opening and the other end side opening of the storage portion 43. A portion 44 is provided. Specifically, two guiding portions 44 are provided so as to face each other, and the inner surfaces of both facing each other are narrower toward the opening of the guiding portion 44 and are close to each other. Further, the end portion of the guide portion 44 is a bent portion. For this reason, it is possible to guide the extension portion 76 of the plunger mounting member 7 to the opening of the guide portion 44. And the end surface of this guidance | induction part 44 becomes a thing substantially continuous with the outer surface of the press part 42, and functions also as a press part.
As a constituent material of the plunger 4, it is preferable to use a hard or semi-rigid resin such as high-density polyethylene, polypropylene, polystyrene, or polyethylene terephthalate.

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.
As shown in FIGS. 1, 2, and 17, the outer cylinder 2 includes a nozzle portion 22 and a collar 23.
The nozzle portion 22 is provided at the distal end of the outer cylinder 2, and is provided with a distal end opening for discharging a chemical solution and the like in the outer cylinder, and is formed so as to decrease in diameter in a tapered shape toward the distal end. The collar 23 is formed in a cylindrical shape concentrically with the nozzle portion 22 so as to surround the nozzle portion 22. The collar 23 is open at the tip, and the inner diameter and outer diameter of the collar 23 are substantially the same from the base end to the tip. Further, the tip of the nozzle portion 22 projects from the tip opening of the collar 23, and the nozzle portion 22 and the tip of the collar 23 accommodate the nozzle portion 22 and the collar 23 in the sealing member (seal cap) 5. It is chamfered to make it easier.
On the inner peripheral surface of the collar, a screw groove (external cylinder side screwing) for screwing with a screw thread (cap side screwing part) 54 formed in a nozzle housing part 53 of a sealing member (seal cap) 5 described later. Part) 25 is formed. Thereby, the outer cylinder 2 and the seal cap 5 are screwed between the collar inner peripheral surface and the nozzle housing portion outer peripheral surface. Further, the thread groove (outer cylinder side screwing portion) 25 is a portion to which the injection needle (the hub of the injection needle) is attached after the seal cap 5 is removed from the outer cylinder.

As shown in FIGS. 1, 2, and 16, the outer cylinder has a flange 24. The flange 24 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 2. As shown in FIGS. 1, 2, and 17, the flange 24 includes two gripping portions that are wide facing each other, and a plurality of ribs are formed on the front end surface side of the gripping portion.
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.

As shown in FIGS. 1, 2, and 18, the seal cap 5 that is a sealing member includes a closed end 51, a nozzle storage portion 53, and a color storage portion 52.
The nozzle storage portion 53 is provided in the center portion of the seal cap 5 and has a cylindrical shape with a closed end. The inner diameter of the nozzle storage portion 53 is made slightly larger than that of the nozzle portion 22 and is slightly tapered from the distal end to the proximal end toward the proximal end, and accommodates the entire nozzle portion from the proximal end opening. ing.
A seal member 55 for sealing the tip opening of the outer cylinder 2 in a liquid-tight manner is accommodated in the inner closed surface of the nozzle storage portion 53 (the inner surface of the closed end 51). The seal member 55 is preferably an elastic member so that the tip opening of the outer cylinder 2 can be sealed in a liquid-tight manner. As a material for forming the sealing member, it is preferable to use, for example, natural rubber, isoprene rubber, butadiene rubber, fluororubber, silicone rubber or other synthetic rubber, or thermoplastic elastomer such as olefin elastomer or styrene elastomer.
Further, on the outer surface of the nozzle housing portion 53, a screw thread (cap side screwing portion) 54 for screwing with a screw groove (outer tube side screwing portion) 25 formed on the inner surface of the collar 23 of the outer tube 2. Is formed. Thereby, the outer cylinder 2 and the seal cap 5 are screwed between the outer surface of the nozzle housing portion and the inner surface of the collar.

The color storage unit 52 is a cylindrical body that is formed so as to surround the nozzle storage unit 53 and has a closed end, and stores the collar 23 between the inner surface of the color storage unit and the outer surface of the nozzle storage unit. Further, the color storage portion 52 formed in a cylindrical shape is concentric with the nozzle storage portion 53, and the inner diameter of the color storage portion 52 is substantially the same from the front end to the base end.
In addition, as shown in FIG. 1, the outer surface of the seal cap 5 (the outer peripheral surface of the color storage portion 52) is chopped in the vertical direction so that fingers do not slip when the seal cap is rotated. ing.
Examples of the material for forming the seal cap 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 the syringe of the above-described embodiment, the mounting member side slide engaging portion 75 of the plunger mounting member 7 includes the holding portion 77 and the extending portion 76 extending in the sliding direction from the end portion of the holding portion 77, and the extending portion. A housing portion 43 and a housing portion, which are male side engaging portions provided with a first fitting portion 76a provided in the portion 76, and in which the plunger side slide engaging portion 40 of the plunger 4 can house the extending portion 76. 43 is a female side engaging portion having a second fitting portion 43a that engages with a first fitting portion 76a provided on the outer surface or inside of the end portion of 43. However, it is not limited to this type.
For example, as shown in FIG. 19, the plunger side slide engaging portion 92 of the plunger 4a is a male side engaging portion, and the mounting member side slide engaging portion 91 of the plunger mounting member 7a is a female side engaging portion. Part. And what was mentioned above can be used conveniently as a structure of a male side engaging part and a female side engaging part. In addition, as shown in FIG. 19, when providing the extension part 76 extended in a sliding direction from the edge part of the holding | maintenance part 77 and the holding | maintenance part 77 in the plunger 4a , the front end side flange part 90 is provided and it provides in the outer surface. It is preferable.

And in the prefilled syringe 1 of this invention, as shown in FIG. 2, the chemical | medical agent storage part formed in the outer cylinder is filled with the chemical | medical agent 8. As shown in FIG.
As the drug 8, any drug may be used. For example, cyclosporine, benzodiazepine drugs, sodium chloride injection, vitamins, minerals, and the like, powders such as antibiotics and protein preparations, or freeze-dried Drugs or liquids are used. The prefilled syringe of the present invention is particularly suitable for a prefilled syringe of the type that is administered using a syringe pump. Therefore, the medicine to be filled is preferably a medicine suitable for using such administration means, and nitro Examples include glycerin injection, isosorbide nitrate injection, dopamine hydrochloride (dopamine hydrochloride) injection, dobutamine hydrochloride injection, morphine hydrochloride injection, and the like.

Next, the effect | action of the prefilled syringe 1 of this invention is demonstrated using FIG. 16, FIG. 20 thru | or FIG.
The prefilled syringe body 10 is in a state in which the gasket 3 is housed in the proximal end portion of the outer cylinder 2. As shown in FIG. 20, the distal end surface of the distal end portion of the plunger 4 is in sliding contact with the proximal end flange portion 78 of the plunger mounting member 7, and the distal end portion of the extending portion 76 enters between the guiding portions 44 facing each other. Thus, the plunger 4 is slid in the lateral direction (arrow direction) with respect to the outer cylinder 2. As a result, the extension portion 76 of the plunger mounting member 7 enters the inside through one opening of the storage portion 43 of the plunger 4. Further, when the entry is advanced, the tip end portion of the extension portion 76 of the plunger mounting member 7 protrudes from the other opening of the storage portion 43 of the plunger 4, and then the first portion formed on the outer surface of the extension portion 76. The first fitting portion 76 a is fitted with the second fitting portion 43 a formed by the outer surface of the end portion of the storage portion 43. This state is shown in FIG. 16, FIG. 21, and FIG. When the fitting is completed, the tip of the extension 76 is exposed from the other opening of the storage portion 43 of the plunger 4 and the fitting sound between the first fitting portion 76a and the second fitting portion 43a. Can be confirmed.
As described above, in this prefilled syringe, the plunger 4 can be mounted on the plunger mounting portion 7 without rotating the plunger, so that liquid leakage hardly occurs during the mounting operation. Further, the mounted plunger is not detached by the plunger mounting member 7. Furthermore, when the mounted plunger 4 is rotated, the plunger mounting member 7 may also rotate following the rotation. However, the helical rib forming portion of the distal end portion 71 of the plunger mounting member 7 is the gasket body 6. In the state of being accommodated in the accommodating portion 62, the plunger mounting member 7 is idled, so that the rotation of the plunger 4 is not transmitted to the gasket body 6.

DESCRIPTION OF SYMBOLS 1 Prefilled syringe 2 Outer cylinder 3 Gasket 4 Plunger 5 Sealing member 6 Gasket main body 7 Plunger mounting member 10 Prefilled syringe main body

Claims (8)

Housed in an outer cylinder, a gasket slidably housed in the outer cylinder, a sealing member for sealing a front end opening of the outer cylinder, and a medicine container formed in the outer cylinder A prefilled syringe body consisting of a prefilled syringe body made of a medicine and a plunger which is attachable to the gasket and is in a non-attached state,
The gasket is a cylindrical body whose front end is closed and the rear end is opened, and has a lumen portion extending from the rear end opening to the front end side, and a plunger mounting member attached to the gasket main body And consist of
The plunger mounting member protrudes forward from the main body portion having a front end flange portion capable of pressing the proximal end surface of the gasket main body, and can be stored in the lumen portion of the gasket main body. A distal end portion, a spiral rib provided on the outer surface of the distal end portion, a proximal end flange portion provided on the proximal end side of the main body portion, and a mounting member provided on the proximal end flange portion A side slide engagement portion,
The gasket main body is provided on the inner surface of the lumen portion, and includes a helical screw portion for screwing with the helical rib of the plunger mounting member, and the helical screw portion of the lumen portion. A storage section provided on the front end side for storing the front end side from the spiral rib forming portion of the plunger mounting member;
The plunger is a plunger-side slide for engaging with a pressing portion capable of pressing the proximal end flange portion of the plunger mounting member and the mounting member-side slide engaging portion when the plunger is mounted on the gasket. An engagement portion,
The mounting-member-side slide engagement portion and the plunger-side slide engagement portion are arranged such that the distal end portion of the plunger is placed laterally with respect to the axial direction of the prefilled syringe body on the proximal end-side flange portion of the plunger mounting member. By sliding, both are engaged, and the mounting member-side slide engaging portion and the plunger-side slide engaging portion are fitted by the progress of the engagement, and the plunger is mounted. A fitting mechanism for preventing the plunger from being detached from the member for use,
One of the mounting member-side slide engaging portion and the plunger-side slide engaging portion is provided in the extending portion that extends in the sliding direction from the end portion of the holding portion, the holding portion, and the extending portion. A male engagement portion including a first fitting portion, the other being a storage portion capable of storing the extension portion, and the first fitting provided on the outer surface or inside of the end portion of the storage portion. A female-side engaging portion having a second fitting portion that fits into the mating portion; and the male-side engaging portion is formed from the holding portion and both side portions of the end portion of the holding portion. Two extending portions extending so as to face each other, and a tip portion of the extending portion is a claw portion having a fitting portion,
The plunger mounting member is mounted on the gasket body in a state where the distal end side from the spiral rib forming portion is stored in the storage portion, and the distal end of the plunger mounting member contacts the inner surface of the gasket body A prefilled syringe characterized by not being used. Housed in an outer cylinder, a gasket slidably housed in the outer cylinder, a sealing member for sealing a front end opening of the outer cylinder, and a medicine container formed in the outer cylinder A prefilled syringe body consisting of a prefilled syringe body made of a medicine and a plunger which is attachable to the gasket and is in a non-attached state,
  The gasket is a cylindrical body whose front end is closed and the rear end is opened, and has a lumen portion extending from the rear end opening to the front end side, and a plunger mounting member attached to the gasket main body And consist of
The plunger mounting member protrudes forward from the main body portion having a front end flange portion capable of pressing the proximal end surface of the gasket main body, and can be stored in the lumen portion of the gasket main body. A distal end portion, a spiral rib provided on the outer surface of the distal end portion, a proximal end flange portion provided on the proximal end side of the main body portion, and a mounting member provided on the proximal end flange portion A side slide engagement portion,
  The gasket main body is provided on the inner surface of the lumen portion, and includes a helical screw portion for screwing with the helical rib of the plunger mounting member, and the helical screw portion of the lumen portion. A storage section provided on the front end side for storing the front end side from the spiral rib forming portion of the plunger mounting member;
  The plunger is a plunger-side slide for engaging with a pressing portion capable of pressing the proximal end flange portion of the plunger mounting member and the mounting member-side slide engaging portion when the plunger is mounted on the gasket. An engagement portion,
  The mounting-member-side slide engagement portion and the plunger-side slide engagement portion are arranged such that the distal end portion of the plunger is placed laterally with respect to the axial direction of the prefilled syringe body on the proximal end-side flange portion of the plunger mounting member. By sliding, both are engaged, and the mounting member-side slide engaging portion and the plunger-side slide engaging portion are fitted by the progress of the engagement, and the plunger is mounted. A fitting mechanism for preventing the plunger from being detached from the member for use,
  The mounting member side slide engaging portion extends from the end portion of the holding portion protruding from the outer surface of the base end side flange portion, and is separated from the outer surface of the base end side flange portion; A male side engaging portion having an extending portion extending substantially parallel to the outer surface and a first fitting portion provided on the extending portion, wherein the plunger has the plunger side slide engaging portion. The plunger-side slide engagement portion includes a storage portion that can store the extension portion, and a first engagement portion that engages with the first fitting portion provided on the outer surface or inside of the end portion of the storage portion. Comprising a female-side engagement portion having two fitting portions, and a distal end surface of the head portion constitutes a pressing portion capable of pressing the proximal-side flange portion,
  The plunger mounting member is mounted on the gasket body in a state where the distal end side from the spiral rib forming portion is stored in the storage portion, and the distal end of the plunger mounting member contacts the inner surface of the gasket body A prefilled syringe characterized by not being used. Housed in an outer cylinder, a gasket slidably housed in the outer cylinder, a sealing member for sealing a front end opening of the outer cylinder, and a medicine container formed in the outer cylinder A prefilled syringe body consisting of a prefilled syringe body made of a medicine and a plunger which is attachable to the gasket and is in a non-attached state,
The gasket is a cylindrical body whose front end is closed and the rear end is opened, and has a lumen portion extending from the rear end opening to the front end side, and a plunger mounting member attached to the gasket main body And consist of
The plunger mounting member protrudes forward from the main body portion having a front end flange portion capable of pressing the proximal end surface of the gasket main body, and can be stored in the lumen portion of the gasket main body. A distal end portion, a spiral rib provided on the outer surface of the distal end portion, a proximal end flange portion provided on the proximal end side of the main body portion, and a mounting member provided on the proximal end flange portion A side slide engagement portion,
The gasket main body is provided on the inner surface of the lumen portion, and includes a helical screw portion for screwing with the helical rib of the plunger mounting member, and the helical screw portion of the lumen portion. A storage section provided on the front end side for storing the front end side from the spiral rib forming portion of the plunger mounting member;
  The plunger is a plunger-side slide for engaging with a pressing portion capable of pressing the proximal end flange portion of the plunger mounting member and the mounting member-side slide engaging portion when the plunger is mounted on the gasket. An engagement portion,
  The mounting-member-side slide engagement portion and the plunger-side slide engagement portion are arranged such that the distal end portion of the plunger is placed laterally with respect to the axial direction of the prefilled syringe body on the proximal end-side flange portion of the plunger mounting member. By sliding, both are engaged, and the mounting member-side slide engaging portion and the plunger-side slide engaging portion are fitted by the progress of the engagement, and the plunger is mounted. A fitting mechanism for preventing the plunger from being detached from the member for use,
  The plunger includes a front end flange portion, a holding portion provided on the outer surface of the front end flange portion, and extends from an end portion of the holding portion, and is spaced apart from the outer surface of the front end flange portion and the outer surface A male-side engagement portion having an extension portion extending substantially parallel to the extension portion and a first fitting portion provided in the extension portion, wherein the mounting member-side slide engagement portion is the base end side A female having a housing part provided in the flange part and capable of housing the extension part, and a second fitting part engaging with the first fitting part provided on the outer surface or inside of the end part of the housing part Having a side engaging portion, and the distal end flange portion of the plunger constitutes a pressing portion that presses the proximal end flange portion of the plunger mounting member,
  The plunger mounting member is mounted on the gasket body in a state where the distal end side from the spiral rib forming portion is stored in the storage portion, and the distal end of the plunger mounting member contacts the inner surface of the gasket body A prefilled syringe characterized by not being used. The male side engaging portion includes the holding portion and the two extending portions extending so as to face the both side portions of the end portion of the holding portion, and a distal end portion of the extending portion has a fitting portion. The prefilled syringe according to claim 2 or 3 which is a nail part. The storage portion of the female side engaging portion can store the extending portion of the male side engaging portion in a state where the fitting portion of the claw portion protrudes, and the The prefilled syringe according to claim 4 , wherein the fitting portion is fitted with an outer end surface of the storage portion when protruding from the storage portion. The female-side engaging portion, one end side opening or / and the other end opening of the housing part, in any of the claims 1 comprises a guiding portion for guiding the male side engaging portion 5 The prefilled syringe as described. The gasket main body includes an annular rib for retaining the plunger that is positioned near and on the tip side of the helical threaded portion, and the annular rib includes the helical rib of the main body portion of the plunger mounting member and the gasket. The guide part for guide | inducing the said helical rib which reached | attained this cyclic | annular rib to the said accommodating part by progress of the screwing with the helical screwing part of a main body is provided in any one of Claim 1 thru | or 6. Prefilled syringe. The pre-filled syringe according to claim 7 , wherein the annular rib is gradually reduced toward the guide portion.

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