JP5714268B2 - Prefilled syringe - Google Patents

Description

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

As the prefilled syringe, there are a type in which the plunger is not attached to the gasket and is attached at the time of use, and a type in which the plunger is attached to the gasket in advance.
The prefilled syringe with the plunger attached to the gasket is 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 a reduced-pressure atmosphere (vacuum atmosphere). The gasket is inserted by using a so-called vacuum plugging method in which the gasket is inserted into the outer cylinder by placing it in a normal pressure state, and then the plunger is attached to the gasket. . 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. Moreover, in the type of prefilled syringe in which the plunger is not attached to the gasket, the user performs an operation of attaching the plunger to the gasket at the time of use.

If the plunger is press-fitted into the gasket when the plunger is attached to the gasket, the chemical solution may leak from the gasket or the nozzle of the outer cylinder due to the pressure. For this reason, in prefilled syringes, a combination of a gasket and a plunger is often used by screwing in which an internal thread is provided on the gasket side and an external thread is provided on the plunger side.
In many cases, the prefilled syringe is used by being attached to a syringe pump. For example, the prefilled syringe is set on the syringe pump. For example, the flange provided at the proximal end of the outer cylinder is attached to the holder of the syringe pump, and the disk provided at the proximal end of the plunger is attached to the slider of the syringe pump. Mounted in the fixed groove. Some types of syringe pumps have a vertical slit for engaging the plunger's axial rib with the slider. For such a model, the plunger's rib is placed in the slider's vertical slit. In order to make it fit, it is necessary to rotate the plunger and make fine adjustments. In the type in which the plunger is attached to the gasket by screwing as described above, the screwing of both may be loosened by the rotation operation of the plunger.

  International Publication WO2006 / 087762 (Patent Document 1) discloses a gasket 3 that slidably closes the inside of a barrel 2 in which a luer taper portion 5 is formed and includes a hollow portion 10 on the inner peripheral side, and a plunger rod. 4 and the plunger rod 4 is connected to the gasket 3 via the flange 11. The flange portion 11 is formed to protrude from a pedestal portion 18 formed of a tapered surface inclined at an angle of 5 to 45 ° with respect to a surface orthogonal to the axial direction of the plunger rod 4, and comes into contact with the back surface side of the tip of the gasket 3. A tip contact portion 22 is provided, and a contact member 12 that is loosely fitted on the outer peripheral side and contacts the inner peripheral wall of the gasket 3 is provided. The pedestal portion 18 includes a concave curved surface 20 between the tip abutting portion 22 and the tapered surface, the abutting member 12 includes a convex curved surface 28a at a portion facing the concave curved surface 20, and the barrel 2 is disposed on the inner surface side. The thing provided with the lock | rock cylinder 6 in which the thread 7 was formed is proposed.

Japanese Patent Application Laid-Open No. 2008-307237 (Patent Document 2) is a prefilled syringe filled with a chemical solution and having a gasket plugged therein, a coupler screwed into the proximal end of the gasket, and a proximal end of the coupler A bottom rod coupled from the side; a stopper formed on the coupler; and an engaging portion formed on the bottom rod that engages with the stopper by rotation of the bottom rod in a screwing direction. Has proposed a prefilled syringe which 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.
The applicant of the present application has proposed the following in Japanese Unexamined Patent Application Publication No. 2009-142508 (Patent Document 3). The syringe 10 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. .

  In Patent Documents 2 and 3, it is necessary to rotate the plunger for mounting the plunger on the gasket. With the thing of patent document 1, the operation | work which rotates a plunger for the mounting to the gasket of a plunger is not required, but it can mount | wear by pushing the front-end | tip part of a plunger into a gasket. However, there is a high possibility that the tip of the plunger will deform the gasket and cause liquid leakage during the mounting operation. In addition, even after the plunger is mounted, there is a possibility that the tip of the plunger may deform the gasket and cause liquid leakage when the plunger is pressed.

International Publication WO2006 / 087762 JP2008-307237 JP 2009-142508 A

  Therefore, an object of the present invention is to push the plunger into the gasket without pushing a high pressure on the gasket, and even if the plunger is rotated after mounting, the plunger and the gasket are loosely coupled. Further, the present invention provides a prefilled syringe which is not given and hardly deforms the gasket even when the plunger is tilted.

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 comprising a prefilled syringe body comprising a stored medicine and a plunger attached to or attachable to the gasket, wherein the gasket is a cylindrical body whose front end is closed and whose rear end is open. And a gasket main body having a lumen extending from the rear end opening to the front end side, and a plunger mounting member attached to the gasket main body, the gasket main body being provided on the inner surface of the lumen A plunger mounting member retaining rib, the plunger mounting member having a hollow portion penetrating from the front end to the rear end and housed in the lumen portion of the gasket body. An outer surface projecting portion that is provided on the outer surface, engages with the plunger mounting member retaining rib of the gasket body, and regulates separation of the plunger mounting member from the gasket body. A plurality of elastically deformable internal protrusions extending from the inner surface of the plunger mounting member toward the center of the plunger mounting member and having free ends at positions not reaching the center of the plunger mounting member, Each of the internal protrusions includes a deformation restricting protrusion extending from the rear end surface in the rear end direction of the plunger mounting member, and each of the internal protrusions deforms in the front end direction when pressed in the front end direction. When it is pushed in the rear end direction, it is deformed in the rear end direction, and the other end of the plunger mounting member does not protrude from the gasket body. Said plunger includes a depressible push portion rear end portion of the gasket in a state of being mounted on the gasket, and protrude the plunger enters possible tip mounting the member from the pressing portion to the distal end side, the An outer surface protrusion that is provided on an outer surface of the distal end portion, engages with the internal protrusion of the plunger mounting member, and regulates the detachment of the plunger from the plunger mounting member ; From the rear end side of the plunger mounting member, the distal end portion enters the plunger mounting member to be mounted on the plunger mounting member. In the state where the plunger mounting member retaining rib of the gasket main body is engaged with the outer protrusion of the plunger mounting member, The plunger is attached to the gasket body, and when the plunger is attached to the gasket, the tip of the plunger does not contact the inner surface of the gasket body, and the plunger is attached. The deformation restricting protrusion of the member can come into contact with the inner wall of the plunger mounting member when the plunger mounting member is deformed in the rear end direction of the internal protrusion when the plunger is pulled. Prefilled syringe.

(2) The base end portion connected to the inner surface of the plunger mounting member of each internal protruding portion of the plunger mounting member is an elastically deformable portion as compared with the other portions of the internal protruding portion. The prefilled syringe as described in 1).
(3) The tip-side surface of each internal protrusion of the plunger mounting member is a flat surface that is substantially orthogonal to the central axis of the plunger mounting member, and the outer surface protrusion of the plunger is the plunger The plunger mounting member engages with the rear end surface of the outer protrusion of the plunger. The surface of the inner protrusion of the plunger mounting member is a flat surface substantially orthogonal to the central axis of the tip of the plunger. The prefilled syringe according to (1) or (2) above, which forms a stopper.
(4) In any one of the above (1) to (3), the inner surface of the free end of each internal protrusion of the plunger mounting member is an arc surface centering on the central axis of the plunger mounting member. The prefilled syringe as described.
(5) The plurality of internal protrusions may be provided in two or more so as to be substantially equiangular with respect to the central axis of the plunger mounting member. Prefilled syringe.
(6) The plunger is mounted on the gasket, and the inner surface of the free end of each internal protrusion of the plunger mounting member is in contact with the outer surface of the tip of the mounted plunger (1) The prefilled syringe according to any of (5) to (5).
(7) In the state where the plunger mounting member is mounted on the gasket body, the body portion forming the hollow portion of the plunger mounting member includes a plunger mounting member retaining rib on the gasket body. The outer surface protruding portion of the plunger mounting member is not pressed against the inner surface of the inner cavity portion of the gasket body, and the plunger mounting member is mounted on the gasket body. The prefilled syringe according to any one of the above (1) to (6), wherein the prefilled syringe is rotatable or slightly movable back and forth in the gasket main body.

  In the prefilled syringe of the present invention, the plunger can be attached to the prefilled syringe body by pushing the tip portion into the plunger attachment member, and there is no need to rotate the plunger at the time of attachment. Further, the separation of the gasket from the plunger after mounting can be reliably suppressed, and even if the mounted plunger is rotated, the rotational force is not transmitted to the gasket body, and the gasket can be deformed. Absent. Further, even if the plunger is tilted, the gasket is rarely deformed, 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. 2 is a cross-sectional view taken along line AA in FIG. FIG. 3 is an enlarged front view of a gasket used in the prefilled syringe of the present invention. 4 is a cross-sectional view taken along line BB in FIG. FIG. 5 is a front view of a gasket body used in the gasket shown in FIG. FIG. 6 is a bottom view of the gasket body shown in FIG. 7 is a cross-sectional view taken along the line CC of FIG. FIG. 8 is a front view of a gasket mounting member used for the gasket shown in FIG. 3. 9 is a cross-sectional view taken along the line DD of FIG. 10 is a plan view of the gasket mounting member shown in FIG. FIG. 11 is a perspective view of the gasket mounting member shown in FIG. 8 as viewed from the front end side. FIG. 12 is a perspective view seen from the rear end side of the gasket mounting member shown in FIG. FIG. 13 is a cross-sectional view of a plunger mounting member used in a prefilled syringe according to another embodiment of the present invention. FIG. 14 is an enlarged front view of a plunger used in the prefilled syringe of the present invention. 15 is a plan view of the plunger shown in FIG. 16 is a perspective view of the plunger shown in FIG. FIG. 17 is an explanatory diagram for explaining the operation of the prefilled syringe of the present invention in a state where the prefilled syringe body and the plunger are mounted. FIG. 18 is an enlarged front view of an outer cylinder used in the prefilled syringe of the present invention. FIG. 19 is an enlarged cross-sectional view of a sealing member (seal cap) used in the prefilled syringe of the present invention.

Hereinafter, the prefilled syringe of this invention is demonstrated using the Example shown on drawing.
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 FIG.
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 gasket body 6 includes plunger mounting member retaining ribs 62 provided on the inner surface of the lumen portion 60.
The plunger mounting member 7 is a cylindrical body that can be accommodated in the inner cavity portion 60 of the gasket body 6, is provided on the outer surface, engages with the plunger mounting member retaining rib 62 of the gasket body 6, and The plunger mounting member extends in the center direction of the plunger mounting member from the outer surface protrusion 73 that regulates the separation of the mounting member 7 from the gasket body 6 and the inner surface (in other words, the inner peripheral surface) of the plunger mounting member 7. A plurality of elastically deformable internal protrusions 75a, 75b, 75c, 75d having free ends at positions that do not reach the center of the plunger, and a plunger mounting member 7 from the rear end surfaces of the internal protrusions 75a, 75b, 75c, 75d The projections 76a, 76b, 76c, and 76d for deformation regulation extending in the rear end direction are provided.

The plunger 4, when attached to the gasket 3, has a pressing part 45 that can press the rear end 67 of the gasket body 6, and a tip that protrudes to the tip side from the pressing part 45 and can enter the plunger mounting member 7. And an outer surface protrusion that is provided on the outer surface of the tip end portion 42 and engages with the internal protrusions 75a, 75b, 75c, 75d of the plunger mounting member 7 and restricts the detachment of the plunger 4 from the plunger mounting member 7. Part 43.
The plunger mounting member 7 is mounted in a state in which the plunger mounting member retaining rib 62 of the gasket body 6 and the outer surface protrusion 73 of the plunger mounting member 7 are engaged, and the plunger 4 is When the gasket 3 is attached, the tip of the tip 42 of the plunger 4 does not contact the inner surface of the gasket body 6. Furthermore, the deformation restricting protrusions 76 a, 76 b, 76 c, 76 d of the plunger mounting member 7 are the rear ends of the syringe 1 of the internal protrusions 75 a, 75 b, 75 c, 75 d of the plunger mounting member 7 when the plunger 4 is pulled. When deformed in the direction, the plunger can be brought into contact with the inner wall (in other words, the inner surface, the inner peripheral surface) of the member 7 for mounting.

The prefilled syringe 1 of this embodiment includes a prefilled syringe body 10 and a plunger 4 attached to the prefilled syringe body 10 (gasket 3).
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 7, the gasket 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 63 provided on the front end side of the outer surface and a rear end side annular rib 64 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 a accommodating part of the member for plunger mounting | wearing. The lumen portion 60 includes a plunger mounting member retaining rib 62 provided on the inner surface of the lumen portion 60 on the inner surface thereof. In this embodiment, the plunger mounting member retaining rib 62 is provided on the distal end side of the lumen portion 60. The plunger mounting member retaining rib 62 is an endless annular rib provided so as to be substantially orthogonal to the central axis of the gasket body 6. The plunger mounting member retaining rib 62 is preferably an annular rib, but may be formed by a plurality of ribs that are not continuous and are arranged on the same circle. The distal end surface of the plunger mounting member retaining rib 62 is an annular standing surface 62 a that stands up from the inner surface of the lumen portion 60. The rear end surface of the plunger mounting member retaining rib 62 is an annular inclined surface 62b whose diameter increases in the rear end direction. Moreover, it is preferable that the plunger mounting member retaining ribs 62 have the same inner diameter portion extending a predetermined length with substantially the same inner diameter. By having such an inner diameter portion, it is possible to reliably prevent the plunger mounting member from being detached from the gasket body when the plunger is pulled toward the rear end. The height of the plunger mounting member retaining rib 62 is preferably 0.5 to 2.0 mm, and more preferably 1.0 to 1.5 mm. Further, the length of the same inner diameter portion of the plunger mounting member retaining rib 62 is preferably 1.0 to 6.0 mm, and more preferably 2.0 to 4.0 mm.

Further, the gasket body 6 includes a protrusion 66 that protrudes toward the rear end at the center of the inner surface of the front end. The protrusion 66 can be brought into contact with the front end of the front end portion 42 of the plunger 4 when the front end of the gasket main body 6 is deformed to the rear end side. Prevent deformation. The protrusion 66 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. Further, the gasket body 6 includes an annular flat plate portion on the rear end surface, and a plurality of ribs 68 projecting to the rear end side are provided on the surface. The rib 68 is capable of contacting and pressing the surface of the pressing portion 45 of the plunger 4. In this embodiment, a plurality of ribs 68 (preferably about 3 to 8 is preferable, and in this embodiment, four) are arranged so as to be equiangular with respect to the central axis of the gasket body 6.
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 63 and the rear end side annular rib 64. 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, 4, 8 to 12, the plunger mounting member 7 is a cylindrical body having a hollow portion penetrating from the front end to the rear end. The plunger mounting member 7 includes a main body 71 that can be accommodated in the lumen 60 of the gasket main body 6, an outer surface protrusion 73 provided on the outer surface of the main body 71, and a plurality of internal protrusions 75a that can be elastically deformed. , 75b, 75c, 75d, and deformation restricting protrusions 76a, 76b, 76c, 76d extending from the rear end surfaces of the inner protrusions 75a, 75b, 75c, 75d toward the rear end of the plunger mounting member 7.
The outer surface protrusion 73 engages with the plunger mounting member retaining rib 62 of the gasket main body 6 and regulates the detachment of the plunger mounting member 7 from the gasket main body 6. In the plunger mounting member 7 of this embodiment, an annular protrusion is provided on the outer surface (specifically, the outer surface of the distal end) of the main body 71 and is substantially orthogonal to the central axis of the plunger mounting member 7. . The rear end surface of the outer surface protrusion (outer surface annular protrusion) 73 is an annular standing surface 73 a that stands up from the outer surface of the main body 71. In addition, as the outer surface protrusion part 73, it is not limited to a cyclic | annular thing, You may consist of a some protrusion part which is not continuous. The height of the outer protrusion 73 is preferably 0.5 to 2.0 mm, particularly preferably 1.0 to 1.5 mm. The outer diameter of the plunger mounting member 7 at the outer surface protruding portion 73 of the plunger mounting member 7 is 1.0 to 4.0 mm larger than the inner diameter of the plunger mounting member retaining rib 62 of the gasket body 6. In particular, it is preferably 2.0 to 3.0 mm larger.

  Further, as shown in FIGS. 4 and 9 to 12, the plunger mounting member 7 extends in the central direction of the plunger mounting member 7 from the axial center of the inner surface of the plunger mounting member 7 (main body portion 71). And a plurality of elastically deformable internal protrusions 75a, 75b, 75c and 75d having free ends at positions not reaching the center of the plunger mounting member. And the front end surface of the free end part of each internal protrusion part 75a, 75b, 75c, 75d forms the latching | locking part for plunger removal which engages with the rear-end surface 43a of the outer surface projection part 43 of the plunger 4 mentioned later. . The main body 71 is a cylindrical portion having a substantially same outer diameter and extending for a predetermined length, and houses a distal end portion 42 of the plunger 4 described later.

In the plunger mounting member 7 of this embodiment, each of the internal protrusions 75a, 75b, 75c, and 75d is connected to the plunger mounting member from the inner surface of the plunger mounting member 7 (main body portion 71) in the axial center portion. It is substantially orthogonal to the central axis and extends in the central direction of the plunger mounting member 7. Moreover, each internal protrusion part 75a, 75b, 75c, 75d has a free end in the position which does not reach the center of the member for plunger mounting | wearing. Further, the base end portions 77a, 77b, 77c, and 77d connected to the inner surface of the plunger mounting member of the inner protruding portions 75a, 75b, 75c, and 75d of the plunger mounting member 7 are internal protruding portions 75a, 75b, 75c, and 75d. Compared to other parts, it is an easily elastic deformation part. Specifically, the base end portions 77a, 77b, 77c, and 77d connected to the inner surface of the plunger mounting member are narrower and easier to elastically deform than the other portions of the internal protrusions 75a, 75b, 75c, and 75d. It has become a thing. The base end portions 77a, 77b, 77c, and 77d connected to the inner surface of the plunger mounting member are thinner than the other portions of the internal projecting portions 75a, 75b, 75c, and 75d, and are easily elastically deformed. It is good.
In the plunger mounting member 7 of this embodiment, the plunger retaining locking portion is formed on the front surface of the free end portion of each of the internal protrusions 75a, 75b, 75c, 75d as described above. Yes. The plunger retaining locking portion (the surface on the distal end side of the free end portion) is a flat surface that is substantially orthogonal to the central axis of the plunger mounting member 7.
It is preferable that two or more internal projecting portions are provided so as to be substantially equiangular with respect to the central axis of the plunger mounting member 7. In particular, the number of the plurality of internal protrusions is preferably 3 to 8.

Each of the internal protrusions of the plunger mounting member is elastically deformable, deforms in the distal direction when pressed in the distal direction, and deforms in the rear end direction when pressed in the rear end direction. is there.
The plunger mounting member 7 includes deformation restricting protrusions 76a, 76b, 76c, and 76d that extend from the rear end surfaces of the internal protrusions 75a, 75b, 75c, and 75d toward the rear end of the plunger mounting member 7. The deformation regulating protrusions 76a, 76b, 76c, and 76d extend substantially parallel to the axial direction of the plunger mounting member 7 from the rear end surfaces of the internal protrusions 75a, 75b, 75c, and 75d. The deformation regulating protrusions 76a, 76b, 76c, and 76d are formed on the plunger mounting member when the internal protrusions 75a, 75b, 75c, and 75d of the plunger mounting member 7 are pushed and deformed in the rear end direction. It abuts against the inner wall and restricts excessive deformation of the inner protrusions 75a, 75b, 75c, 75d of the plunger mounting member. By having the deformation restricting protrusions 76a, 76b, 76c, and 76d, the plunger 4 can be reliably prevented from being detached from the plunger mounting member 7.
Further, like the plunger mounting member 7a of the embodiment shown in FIG. 13, the inner surfaces (inner side surfaces) of the deformation restricting protrusions 76a, 76b, 76c, 76d are the free ends of the inner protrusions 75a, 75b, 75c, 75d. It is good also as the inclined surfaces 78a, 78b, 78c, 78d which incline toward. By doing in this way, engagement with the latching | locking part of the member for plunger mounting of the engaging part of the plunger 4 becomes easy.

Moreover, it is preferable that the inner surface of the free end of each internal protrusion 75a, 75b, 75c, 75d of the plunger mounting member 7 is a circular arc surface that is substantially centered on the central axis of the plunger mounting member 7.
As shown in FIG. 4, the plunger mounting member 7 is mounted in a state where the plunger mounting member retaining rib 62 of the gasket body 6 and the outer surface protruding portion 73 of the plunger mounting member 7 are engaged. Yes. The plunger mounting member 7 mounted on the gasket main body 6 has a rear end that does not protrude from the gasket main body 6, in other words, the plunger mounting member 7 has a base end in the state mounted on the gasket main body 6. However, it is located in the front end side of predetermined length from the base end of a gasket main body. Further, in a state where the plunger mounting member 7 is mounted on the gasket body 6, the body portion 71 of the plunger mounting member 7 is not in pressure contact with the plunger mounting member retaining rib 62 of the gasket body 6, and the plunger The outer surface protruding portion 73 of the mounting member 7 is also not in pressure contact with the inner surface of the lumen portion 60 of the gasket body 61. Therefore, the plunger attachment member 7, in a state of being attached to the gasket body 6, the internal hand rotatable, and has a slightly movable back and forth. The outer diameter of the plunger mounting member 7 in the main body 71 is preferably 1.0 to 4.0 mm larger than the inner diameter of the plunger mounting member retaining rib 62 of the gasket main body 6. It is preferably 0 to 3.0 mm larger.
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, 2, 14 to 16, the plunger 4 includes a plunger main body 41 and a pressing portion 45 capable of pressing the rear end of the gasket main body 6 in a state of being attached to the gasket 3. The front end portion 42 protrudes from the pressing portion 45 toward the front end side and can enter the hollow portion of the plunger mounting member 7, and is provided on the outer surface of the front end portion 42, and constitutes a plunger retaining locking portion of the plunger mounting member 7. And an outer surface protrusion 43 that engages with the surface on the front end side of the free end portion of each internal protrusion 75a, 75b, 75c, 75d. The tip portion 42 is preferably a cylindrical tip portion, a rod-like tip portion, a columnar tip portion, or the like, and in particular, a cylindrical tip portion is preferable.
The plunger 4 can be mounted on the plunger mounting member 7 by pushing the tip 42 into the hollow portion of the plunger mounting member 7. The plunger 4 is configured such that the plunger tip 42 does not contact the inner surface of the gasket body 6 when the plunger 4 is attached to the gasket 3.
The pressing part 45 is located at the tip of the plunger main body 41 and is formed in a disc shape. Further, the plunger main body 41 is formed in a cross shape as shown in FIGS. 14 and 16, a pressing portion 45 is provided at the front end, and a disc-shaped rear end pressing portion 47 is provided at the rear end, In the middle, a reinforcing rib 48 is provided.
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.

In the plunger 4 of this embodiment, the outer surface protrusion 43 that engages with the surface on the distal end side of the free end portion of the inner protrusions 75 a, 75 b, 75 c, 75 d of the plunger mounting member 7 is It is provided on the outer surface of the part (specifically, the outer surface of the tip) and is formed by an annular outer surface protrusion that is substantially orthogonal to the central axis of the tip 42 of the plunger 4. The rear end surface of the outer surface protrusion (outer surface annular protrusion) 43 is an annular standing surface that stands up from the outer surface of the front end portion 42. In addition, as the outer surface projection part 43, it is not limited to a cyclic | annular thing, You may consist of a some protrusion part which is not continuous. The height of the outer surface protrusion 43 is preferably 0.3 to 1.5 mm, and particularly preferably 0.5 to 1.0 mm. And the outer diameter in the outer surface protrusion part 43 part is 0.5-3.0 mm larger than the diameter of the circle | round | yen which the inner surface of the free end of each internal protrusion part 75a, 75b, 75c, 75d of the member 7 for plunger mounting forms. It is preferable that it is a thing, and it is especially preferable that it is 1.0-2.0 mm large.
When the distal end portion 42 including the outer surface protruding portion 43 of the plunger 4 is pushed into the hollow portion of the plunger mounting member 7, the outer surface protruding portion 43 portion becomes the inner protruding portions 75 a, 75 b, 75 c, 75 d of the plunger mounting member 7. By pressing and elastically deforming, the outer surface protrusion 43 portion passes through the inner protrusions 75a, 75b, 75c, and 75d, and then the inner protrusions 75a, 75b, 75c, and 75d are restored to their original shapes or By substantially restoring, the rear end surface portion of the outer protrusion 43 and the front end surface of the free end portions of the inner protrusions 75a, 75b, 75c, 75d are engaged. As a result, the detachment of the plunger 4 from the plunger mounting member 7 is restricted.

In the plunger 4 of this embodiment, the inner surface of the free end of each of the internal protrusions 75a, 75b, 75c, 75d of the plunger mounting member 7 is the tip of the plunger 4 when mounted on the plunger mounting member 7. It is in contact with the outer surface of the part 42. In the state where the plunger mounting member 7 is mounted, as shown in FIG. 17, the inner surface of the free end of each of the internal protrusions 75 a, 75 b, 75 c, 75 d of the plunger mounting member 7 is the tip portion 42 of the plunger 4. It may be pressed against the outer surface and pressed in a slightly expanding direction. By doing so, the backlash of the gasket is reduced.
Further, in the prefilled syringe of this embodiment, as shown in FIGS. 1, 2 and 17, the gasket 3 is positioned on the distal end side of a predetermined length from the proximal end of the outer cylinder, and the pressing portion 45 of the mounted plunger 4 is used. However, it is located in the outer cylinder. For this reason, the inclination of the mounted gasket is suppressed.

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 24 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 3 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.
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 and 18, 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 main body portion 21. The flange 24 includes two gripping portions that are wide and facing each other, and a plurality of ribs are formed on the tip surface side of the gripping portion. Further, the rear end surface of the flange 24 has a concave portion at the peripheral edge and the outer cylinder rear end portion other than the rib portion.
As shown in FIG. 18, the nozzle portion 22 includes an injection needle mounting portion that decreases in diameter toward the tip. In the present embodiment, the nozzle side screwing portion 23 provided on the rear end side from the tip portion is provided. In the present embodiment, the sealing member 5 is attached by the nozzle side screwing portion 23, but the sealing member 5 may be attached by other known means.
In this embodiment, as shown in FIG. 18, the nozzle portion includes a nozzle base portion 25 provided between the base end of the tip and the outer cylinder main body portion 21. A nozzle side engaging portion 26 is provided on the side surface of the nozzle base portion 25. The nozzle side engaging portion 26 is formed by a rib.

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 polyesters and cyclic polyolefins are preferable, and among them, resins such as polypropylene and cyclic polyolefins 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 sealing member in order to improve sealing performance. If it does in this way, at the time of attachment of sealing member 5 to nozzle part 22, sealing member 5 will stick to nozzle part 22 with screwing operation, and it can raise sealability more.
The drug solution 8 filled in the syringe body 10 may be any type, for example, high-concentration sodium chloride injection solution, minerals, heparin sodium aqueous solution, nitroglycerin, isosorbide nitrate, cyclosporine, benzodiazepine, antibiotics Substances, vitamins (general vitamins), various amino acids, antithrombotics such as heparin, insulin, antitumor agents, analgesics, cardiotonic agents, intravenous anesthetics, antiparkinson agents, ulcer treatments, corticosteroids, Any of arrhythmic agents, correction electrolytes, antiviral agents, immunostimulants, etc. may be used. In particular, a chemical solution that is set in a syringe pump and requires continuous micro-administration is preferable.

Next, the sealing member 5 will be described.
As the sealing member 5, either a seal cap or an injection needle (not shown) may be used. Known seal caps or injection needles are used.
As shown in FIG. 19, the sealing member 5 in this embodiment includes an inner cylinder portion 52 having a closing portion 53, an outer cylinder portion 51 formed so as to surround the inner cylinder portion 52, and an inner cylinder portion 52, The seal cap includes a connecting portion 55 that connects the outer cylinder portion 51. In the sealing member 5, the inner cylinder part 52 and the outer cylinder part 51 are integrated by the connection part 55 in the perimeter of the rear-end part.
As shown in FIG. 19, the sealing member 5 includes a tip portion storage portion 57 that stores the injection needle mounting tip portion of the nozzle portion 22 of the outer cylinder 2, and a cap side screw that is screwed to the nozzle side screw portion 23. A joining portion 54 and a seal member 56 that contacts the tip opening surface of the chip portion and seals the tip opening are provided. The base end portion of the inner cylindrical portion 52 is a cylindrical space having substantially the same inner diameter, and a cap-side screwing portion 54 that engages with the nozzle-side engaging portion 23 is provided on the inner surface. In this embodiment, the cap side screwing portion 54 has two spiral shapes. 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, in this embodiment, as shown in FIG. 19, the sealing member 5 is formed on the inner surface of the proximal end opening, and is engaged with the nozzle side engaging portion 26 of the outer cylinder. A portion 58 is provided. The sealing member side engaging portion 58 is constituted by a concave portion formed between two ribs.
As a forming material when the sealing member 5 is a seal cap, for example, polypropylene, polyethylene, polystyrene, polyamide, polycarbonate, polyvinyl chloride, poly- (4-methylpentene-1), acrylic resin, acrylonitrile-butadiene- Various resins such as styrene copolymers, polyesters such as polyethylene terephthalate, and cyclic polyolefins can be used. Among them, resins such as polypropylene and cyclic polyolefins are preferable because they are easy to mold and have heat resistance.

Next, the effect | action of the prefilled syringe 1 of this invention is demonstrated using FIG.
The prefilled syringe body 10 is in a state in which the gasket 3 is accommodated in the rear end portion of the outer cylinder 2. As shown in FIG. 17, the plunger 4 is inserted into the outer cylinder 2 from the distal end portion 42, the distal end portion 42 of the plunger 4 enters the hollow portion of the plunger mounting member 7, and is further pushed into the plunger 4. The outer surface protrusion 43 of the distal end portion 42 presses the inner protrusions 75a, 75b, 75c, and 75d of the plunger mounting member 7 and elastically deforms them to pass through the inner protrusions 75a, 75b, 75c, and 75d. Thereafter, the inner projecting portions 75a, 75b, 75c, and 75d are restored or substantially restored to their original shapes, whereby the rear end surface portion of the outer projection 43 and the free end portions of the inner projecting portions 75a, 75b, 75c, and 75d. The front end side surface of the is engaged. As a result, the detachment of the plunger 4 from the plunger mounting member 7 is restricted. Further, in the plunger 4 of this embodiment, the plunger 4 can move slightly back and forth when mounted on the plunger mounting member 7. When the plunger 4 is pulled rearward (in other words, pulled backward), the inner protrusions 75a, 75b, 75c, and 75d are pushed rearward by the rear end surface 43a of the outer surface projection 43 of the plunger 4 and curved. As a result, the leading ends (rear ends) of the deformation regulating protrusions 76a, 76b, 76c, and 76d abut against the inner wall of the plunger mounting member 7, and further restrict the rearward movement of the plunger 4. The excessive deformation of the internal protrusions 75a, 75b, 75c, 75d of the plunger mounting member is restricted.
And in this prefilled syringe, the mounting | wearing can be performed by pushing in simply, without rotating a plunger. Further, the mounted plunger is not separated by the plunger mounting member 7. Further, when the mounted plunger 4 is rotated, only the plunger 4 may rotate into the plunger mounting member 7, or the plunger mounting member 7 may also rotate following the plunger mounting. It 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 (7)

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 comprising a prefilled syringe body made of a medicine and a plunger attached to or attachable to the gasket,
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 gasket body includes a plunger mounting member retaining rib provided on the inner surface of the lumen portion,
The plunger mounting member has a hollow portion penetrating from the front end to the rear end, and is a cylindrical body that can be stored in the lumen portion of the gasket body, provided on the outer surface, and mounted on the plunger of the gasket body. An outer surface protruding portion that engages with a member retaining rib and regulates the detachment of the plunger mounting member from the gasket body, and extends from the inner surface of the plunger mounting member toward the center of the plunger mounting member, A plurality of elastically deformable internal protrusions having free ends at positions that do not reach the center of the plunger mounting member, and each of the internal protrusions extends from the rear end surface toward the rear end of the plunger mounting member. comprising a deformation restricting projections extending and wherein each internal protrusion is deformed in the distal direction when pushed in the distal direction, to deform toward the rear end when pushed toward the rear end Are those, furthermore, the other end of the plunger attachment member is adapted as not to protrude from the gasket body,
The plunger has a pressing part capable of pressing the rear end part of the gasket in a state of being attached to the gasket, a front end part protruding from the pressing part to the front end side and entering the plunger mounting member, An outer surface protrusion that is provided on an outer surface of the distal end portion, engages with the internal protrusion of the plunger mounting member, and regulates the detachment of the plunger from the plunger mounting member ; From the rear end side of the plunger mounting member, the distal end portion enters the plunger mounting member to be mounted on the plunger mounting member.
Further, the plunger mounting member is mounted on the gasket body in a state where the plunger mounting member retaining rib of the gasket body is engaged with the outer surface protruding portion of the plunger mounting member, and In the state where the plunger is mounted on the gasket, the tip of the plunger is not in contact with the inner surface of the gasket body, and the deformation restricting protrusion of the plunger mounting member is A prefilled syringe, wherein the plunger mounting member can be brought into contact with an inner wall of the plunger mounting member when the plunger mounting member is deformed in the rear end direction of the plunger mounting member when the plunger is pulled. The base end part connected with the inner surface of the said plunger mounting member of each internal protrusion part of the said plunger mounting member is an easily elastic deformation part compared with the other part of the said internal protrusion part. Prefilled syringe. The surface on the tip side of each internal protrusion of the plunger mounting member is a flat surface that is substantially orthogonal to the central axis of the plunger mounting member, and the outer surface protrusion of the plunger is the tip of the plunger. The front surface of the inner protrusion of the plunger mounting member has a plunger retaining locking portion that engages with the rear end surface of the outer protrusion of the plunger. The prefilled syringe according to claim 1 or 2, wherein the prefilled syringe is formed. The prefilled syringe according to any one of claims 1 to 3, wherein an inner surface of a free end of each internal protrusion of the plunger mounting member is an arc surface centering on a central axis of the plunger mounting member. 5. The prefilled syringe according to claim 1, wherein two or more of the plurality of internal protrusions are provided so as to be substantially equiangular with respect to a central axis of the plunger mounting member. 6. The plunger according to claim 1, wherein the plunger is attached to the gasket, and an inner surface of a free end of each internal protrusion of the plunger attachment member is in contact with an outer surface of a tip portion of the attached plunger. The prefilled syringe in any one. When the plunger mounting member is mounted on the gasket body, the body portion forming the hollow portion of the plunger mounting member is not in pressure contact with the plunger mounting member retaining rib of the gasket body. And the outer surface protruding portion of the plunger mounting member is also not in pressure contact with the inner surface of the lumen portion of the gasket body, and the plunger mounting member is mounted on the gasket body. The prefilled syringe according to any one of claims 1 to 6, wherein the prefilled syringe can be rotated inside the gasket main body or can be slightly moved back and forth.

Images