WO2001097885A1

WO2001097885A1 - Syringe

Info

Publication number: WO2001097885A1
Application number: PCT/JP2001/005216
Authority: WO
Inventors: Masaru Saiki
Original assignee: Terumo Kabushiki Kaisha
Priority date: 2000-06-19
Filing date: 2001-06-19
Publication date: 2001-12-27
Also published as: AU2001274548A1; JP4623927B2

Abstract

A syringe in which a plunger and a gasket have a sufficient coupling force and which is easy to assemble. A syringe (1), which is a prefilled syringe, comprising an outer cylindrical bottomed sleeve (2), a gasket (3), and a plunger (4). The plunger (4) and the gasket (3) are joined by threaded engagement between a male thread (51) formed in the head (43) of the front end of the plunger and a female thread (52) formed in the inner surface of the hollow portion (33) of the gasket (3) and by engagement between each projection (62) and an engaging projection (63).

Description

Syringe

TECHNICAL FIELD The present invention relates to a liquid containing a liquid such as a chemical liquid.

BACKGROUND ART A syringe containing a chemical solution or the like in advance is provided with an outer cylinder, a gasket inserted into the outer cylinder, and a plunger (pusher) connected to the gasket, and is surrounded by the outer cylinder and the gasket. Liquid is stored in the empty space. In such a prefilled syringe, the connection between the gasket and the plunger employs a threaded structure using a female screw and a male screw. However, in such a screwing structure, when the plunger rotates in a predetermined direction with respect to the outer cylinder, the screwing may be loosened and come off. Also, if the screw of the screw structure is loose, the plunger may come off from the gasket when the pulling operation is performed!

DISCLOSURE OF THE INVENTION An object of the present invention is to provide a syringe in which a plunger and a gasket have a sufficient bonding force and are easy to assemble. Such an object is achieved by the present invention described in the following (1) to (10).

(1) A syringe comprising an outer cylinder, a gasket slidable in the outer cylinder, and a plunger for moving and operating the gasket,

The gasket and the plunger are connected by a screwing portion that is connected by screwing screws provided inside the gasket and the plunger, respectively, and a fitting portion that is connected by fitting provided between the inside of the gasket and the plunger. A syringe characterized by being used.

(2) The syringe according to (1), wherein the fitting portion is located deeper in the gasket than the screw portion.

(3) When connecting the plunger and the gasket, by the action of the screw portion, the plunger moves so as to enter the inside of the gasket while rotating, and the movement causes the fitting portion to move. The syringe according to (1) or (2) to be fitted.

(4) The syringe according to any one of (1) to (3), wherein, when connecting the plunger and the gasket, the screwing of the screwing portion and the fitting of the fitting portion are substantially simultaneously completed. .

(5) The fitting portion has at least one elastic piece provided on the plunger, and a projection formed on the elastic piece and capable of engaging with the gasket (1) to (4). The syringe described in Crab.

(6) The syringe according to any one of (1) to (5), wherein the fitting portion has a sliding surface for facilitating an operation leading to fitting.

(7) The syringe according to (6), wherein the sliding surface is a curved surface or a tapered surface.

(8) A liquid is stored in a space surrounded by the outer cylinder and the gasket. The syringe according to any one of (1) to (7).

(9) The liquid is not leaked due to the deformation of the gasket caused by the connection between the plunger and the gasket. (8) Brief description of the drawings

FIG. 1 is a partial longitudinal sectional view showing an embodiment (disassembled state) of a syringe of the present invention.

FIG. 2 is a partial longitudinal sectional view showing an embodiment (assembled state) of the syringe of the present invention.

FIG. 3 is a half-sectional view showing the structure of the screwing portion and the fitting portion (the structure before connection) in the syringe of the present invention.

FIG. 4 is a half sectional view showing the structure of the screwing portion and the fitting portion (structure in the middle of connection) in the syringe of the present invention.

FIG. 5 is a half cross-sectional view showing the structure (structure after connection) of the screwing part and the fitting part in the syringe of the present invention.

FIG. 6 is a front view of the tip of the plunger in the syringe of the present invention. BEST MODE FOR CARRYING OUT THE INVENTION

Hereinafter, a syringe of the present invention will be described in detail based on a preferred embodiment shown in the accompanying drawings.

1 and 2 are partial longitudinal sectional views showing an embodiment of the syringe of the present invention, respectively. FIGS. 3 to 5 are, respectively, a screwing portion and a fitting portion of the syringe of the present invention. FIG. 6 is a front view of the tip of the plunger. For convenience of explanation, the upper side in FIGS. 1 to 5 is referred to as a “base end”, and the lower side in FIG.

The syringe 1 of the present invention is a so-called pre-filled syringe, and includes an outer cylinder (syringe outer cylinder) 2, a gasket 3 slidable in the outer cylinder 2, and a plunger (pusher) 4 for moving the gasket 3. And The gasket 3 and the plunger 4 are connected (coupled) by a connecting mechanism described later.

The outer cylinder 2 is formed of a bottomed cylindrical member, and a reduced diameter portion 22 having a diameter reduced with respect to the body of the outer cylinder 2 is formed at the center of the bottom 21. For example, a needle tube hub (not shown), connectors, and the like are fitted and attached to the reduced diameter portion 22. A film 24 is adhered as a sealing member to the distal end of the reduced diameter portion 22 to hermetically seal the lumen 23 of the reduced diameter portion 22.

The method of sealing the reduced diameter portion 22 is not limited to the method using the film 24, and may be, for example, a flexible plug or a cap (not shown).

A plate-like flange 25 is provided on the outer periphery of the base end of the outer cylinder 2. For example, when the plunger 4 is moved relative to the outer cylinder 2, the operation can be performed by putting a finger on the flange 25. The flange 25 may be formed integrally with the outer periphery of the base end of the outer cylinder, or the flange 25 and the outer cylinder 2 may be separately manufactured and joined.

The constituent materials of the outer cylinder 2 and the later-described plunger 4 include, for example, polyvinyl chloride, polyethylene, polypropylene, polystyrene, poly (4-methylpentene-1 1), polyacrylonitrile, acrylic resin, and acrylic nitrile. (I) Polystyrene such as butadiene-styrene copolymer and polyethylene terephthalate There are various resins such as ter, butadiene-styrene copolymer, and polyamide (for example, nylon 6, nylon 6,6, nylon 6,10, nylon 12). Among them, molding is easy. In this respect, resins such as polypropylene and poly (4-methylpentene-11) are preferred.

It is preferable that the constituent material of the outer cylinder 2 is substantially transparent in order to secure the visibility of the inside.

As shown in FIG. 2, a liquid 7 is stored in the syringe 1 in a liquid-tight manner in a space surrounded by the outer cylinder 2 and the gasket 3.

Liquid 7 includes, for example, carbohydrate injections such as glucose, electrolyte correction injections such as sodium chloride and lactate, vitamins, vaccines, antibiotic injections, contrast agents, steroids, and protease inhibitors. , Fat emulsions, anticancer agents, anesthetics, stimulants, various drug solutions such as narcotics, or distilled water, disinfectants, liquid foods, alcohols and the like.

The dimensions of the syringe 1, more specifically, the inner diameter and length of the outer cylinder 2 and the outer diameter of the gasket 3 can be appropriately selected according to the amount of the liquid 7 stored therein.

As shown in FIG. 1, a scale 27 may be formed on the outer peripheral surface of the outer cylinder 2 and is also preferable. Thereby, the amount of the liquid 7 in the syringe 1 can be grasped.

A gasket 3 made of a flexible material is accommodated in the outer cylinder 2. The gasket 3 has a hollow portion 3 3. The gasket 3 slides in the longitudinal direction of the outer cylinder 2, either on the proximal end side or the distal end side, by operating the plunger 4 described later. Can be.

As shown in the figure, a plurality of ring-shaped protrusions 31 may be formed on the outer circumference of the gasket 3 over the entire circumference. The protrusion 31 slides while being in close contact with the inner peripheral surface 26 of the outer cylinder 2, whereby the liquid tightness is more reliably maintained and the slidability is improved.

In the present embodiment, three projections 31 are formed along the longitudinal direction of the gasket 3, but the formation position and the number of the projections 31 are not limited to this.

The constituent material of the gasket 3 is not particularly limited. For example, various rubber materials such as natural rubber, butyl rubber, isoprene rubber, butadiene rubber, styrene-butadiene rubber, silicone rubber, polyurethane, polyester, and poly Elastic materials such as various thermoplastic elastomers such as amides, olefins, and styrenes, and mixtures thereof are exemplified.

Note that the gasket 3 only needs to have at least the outer peripheral portion made of the above-described elastic material. For example, the gasket 3 has a core portion (not shown) made of a resin material. May be configured such that the non-volatile material is disposed so as to cover the surface. In this case, female threads 52 and Z or engagement protrusions 63 described later are formed in the core configured to have the lumen.

The gasket 3 has an outer periphery formed of, for example, polytetrafluoroethylene or a copolymer thereof, an ethylene-tetrafluoroethylene copolymer, tetrafluoroethylene, PVdE (polyvinylidene flow). Ride), PCTFE (polychlorotrifluoroethylene), TFE (tetrafluoroethylene), FEP (futsudani ethylene propylene) and other films composed of a fluororesin. Thereby, the slidability of the gasket 3 with respect to the inner peripheral surface 26 of the outer cylinder 2 is improved. A plunger 4 for moving the gasket 3 in the longitudinal direction in the outer cylinder 2 is connected to the gasket 3.

1 and 2, the plunger 4 is formed of a cross-shaped plate piece having a cross-section, and two plate members 41 are integrally formed on the tip side thereof. However, the shape of the plunger 4 is not limited to this, and may be a cylindrical body having an outer diameter smaller than the outer diameter of the gasket 3. At the base end of the plunger 4, a plate-like flange 42 is provided. The plunger 4 is operated by pressing the flange 42 with a finger or the like. The flange 42 may be formed integrally with the base end of the plunger 4, or the flange 42 and the plunger 4 may be separately manufactured and joined.

At the tip of the plunger 4, a head portion (connecting portion) 43 which is inserted into the hollow portion 33 of the gasket 3 and is connected to the gasket 3 is formed.

Hereinafter, the connection structure between the head portion 43 and the gasket 3 will be described.

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. A threaded portion 5 is formed by the male screw 51 and the female screw 52. In the figure, the male screw 51 is formed substantially at the center in the longitudinal direction of the head portion 43, but the position where the male screw 51 is formed is not limited to this. In addition, a concave portion that is not continuous with the female screw 52 may be provided on the distal end side of the female screw 52. Further, the head portion 43 includes a flexible piece 61 disposed on the distal end side of the male screw 51, and a protruding portion 62 protruding in the outer peripheral direction near the end of each elastic piece 61. Has ing. For example, as shown in FIG. 6, four conductive pieces 61 may be arranged at 90 ° intervals along the outer peripheral surface of the head part 43. However, the number and arrangement of the conductive pieces 61 are not limited thereto, and two larger conductive pieces 61 are arranged at 180 ° intervals on the outer peripheral surface of the head portion 43 so as to face each other. Alternatively, a larger number of the natural pieces 61 may be arranged at smaller intervals. Each of the resilient pieces 61 can be elastically deformed toward the center of the head portion 43, whereby the protrusion 62 is displaced in the same direction.

The elastic pieces 61 and the projections 62 may be arranged in an annular shape when the gasket itself has sufficient elasticity and elastic deformation when connected to the gasket.

The surface (sliding surface) on the distal end side of the protrusion 62 is formed of a curved surface 621, so that the operation leading to engagement with the engagement protrusion 63 can be performed easily and reliably. You may. The curved surface 621 is a curved convex surface, but may be a curved concave surface. In addition, a tapered surface (inclined surface) may be used instead of the curved surface 6 21.

On the other hand, a ring-shaped engagement protrusion 63 is formed on the inner peripheral surface on the distal end side by the female screw 52 of the hollow portion 33 of the gasket 3.

The base end surface (sliding surface) of the engaging projection 63 is tapered (inclined) so that the operation leading to engagement with the projection 62 can be performed easily and reliably. It may be composed of 6 3 1. Note that, instead of the tapered surface 631, a curved surface may be used.

Each of the elastic pieces 61, the protrusions 62, and the engagement protrusions 63 as described above forms the fitting portion 6. In the fitting portion 6, the protrusions 62 formed on each of the elastic pieces 61 engage with the engagement protrusions 63, so that the head portion 43 fits into the gasket 3. As described above, in the syringe 1 of the present invention, the screwing portions 5 provided in the gasket interior and the plunger are screwed together, and the fitting portions 6 provided in the gasket interior and the plunger are fitted. As a result, the plunger 4 and the gasket 3 are connected. As a result, a stronger connected state (bonded state) can be obtained.

In this connection state, the screwing portion 5 and the fitting portion 6 are both located in the hollow portion 33 of the gasket 3. In this case, the fitting portion 6 is located on the tip side of the screwing portion, that is, at the back of the hollow portion 33. Thus, after the screwing is started, the plunger 4 is introduced into the gasket 3 while rotating, and moves so as to enter the inside of the gasket by the action of the spiral in the screwing portion 5. With this movement, the protrusion 62 moves so as to get over the engagement protrusion 63, and the protrusion 62 and the engagement protrusion 63 are engaged. Then, when the screwing portion 5 is completely screwed, the fitting portion 6 is in a working (fitting) state. Here, the state in which the screw portion 5 is completely screwed means that the tip of the male screw 51 has reached the tip of the female screw 52. Further, when a concave portion that is not continuous with the female screw 52 is provided at the distal end portion of the female screw 52, it indicates a state in which the distal end of the male screw 51 reaches this concave portion and is not fitted.

The height H of the engaging projection 63 (the height of the wall portion on the distal end side) is not particularly limited, but is usually preferably about 0.5 to 5.0 mm, and about 0.7 to 1.2 mm. Is more preferred. If the height H is too low, the fitting of the fitting portion 6 (the engagement between the projection 62 and the engagement projection 63) is likely to be released, and if the height H is too high, the fitting portion 6 At the time of fitting, the amount of deformation of the gasket 3 when the protrusion 62 crosses over the engagement protrusion 63 increases, and the liquid 7 may leak. The height H of the engaging projection 63 can be appropriately selected from the above-described preferred range. For example, in the case of a 1 mL size syringe used for administering a small amount of vaccine, the inner diameter of the outer cylinder 2 is as small as 10 mm or less (about 5 to 10 mm). The height H is preferably about 0.7 mm.In the case of a syringe with a size of 5 mL used for injecting a large amount of drug, the inner diameter of the outer cylinder 2 is about 3 Omm. The height H of the contact portion 62 is preferably about 1.2 mm. Although one fitting portion 6 is shown, a plurality of fitting portions 6 may be present. That is, there may be a plurality of fitting protrusions 62 and a plurality of engaging protrusions 63, and fittings 6 may be formed at a plurality of places by the corresponding fitting protrusions 62 and the engaging protrusions 63. . In this case, the fitting projection 62 located on the more distal end side of the plunger 4 also passes over the engagement projection 63 that does not form the fitting 6, so that the fitting projection located on the more proximal side is located. Preferably, the height is lower than 62. It is preferable that the height of the engaging projection 63 on the gasket side to be fitted therewith be higher on the distal end side.

Next, an example of a method of assembling the syringe 1 will be described.

The gasket 3 is inserted into a predetermined position in the outer cylinder 2, and a liquid (chemical solution, etc.) is introduced into the outer cylinder 2 from the distal end opening of the reduced diameter portion 22 of the outer cylinder 2.

Next, a film 24 is adhered to the end of the reduced diameter portion 22 by a method such as fusion and adhesion, and the opening of the end of the reduced diameter portion 22 is sealed.

Alternatively, after sealing the end of the reduced diameter portion 22, a liquid (chemical solution, etc.) is put into the outer cylinder 2, and the gasket 3 is inserted.

Next, the plunger 4 is inserted from the base end opening of the outer cylinder 2, and the head portion 43 is inserted into the hollow portion 33 of the gasket 3 and connected (see FIG. 3). First, the outer cylinder 2 is held in one hand, and the plunger 4 is rotated in a predetermined direction while being held in the other hand. As a result, the male screw 51 is screwed into the female screw 52, and the plunger 4 moves so as to gradually enter the gasket 3 toward the distal end while rotating.

When the movement of the plunger 4 in the tip direction advances to some extent, each protrusion 62 and the engagement protrusion 63 come into contact with each other (see FIG. 4). At this time, the curved surface 6 21 of each projection 62 contacts the tapered surface 6 31 of the engagement projection 63.

When the plunger 4 is further rotated in the same direction, the plunger 4 moves in the distal direction, and the curved surface 6 2 1 of each projection 6 2 comes into sliding contact with the tapered surface 6 3 1 of the engagement projection 6 3, and the elastic piece 6 1 is elastically deformed toward the center of the plunger 4, and at the same time, the engagement projections 63 of the gasket 3 are elastically deformed toward the outer cylinder surface, and each projection 62 is engaged with the engagement projection 63. (See Figure 5). Thereby, each protrusion 62 and the engagement protrusion 63 engage with each other, and the fitting of the fitting portion 6 is completed.

Also, at this time, the male screw 51 moves to the distal end side of the female screw 52 in the screwed portion 5, and the screwing is completed, and the screw is removed.

When each protrusion 62 crosses over the engagement protrusion 63, the pressing force acts on the engagement protrusion 63, so that the gasket 3 is deformed. However, depending on the material (rigidity), shape, dimensions, etc. of the male screw 51, the female screw 52, the elastic piece 61, the projection 62, the engagement projection 63, and their peripheral portions, the gasket 3 Even during deformation, the liquid 7 is prevented from leaking.

The assembly of the syringe 1 is completed as described above.

In addition to the fact that the screw of the threaded part 5 has already been removed, When the plunger 4 is rotated in the opposite direction to the above, the movement is prevented because the projections 62 are engaged with the engagement projections 63. Therefore, the plunger 4 only rotates and does not come off the gasket 3.

As described above, once the plunger 4 and the gasket 3 are connected to each other, the syringe 1 has a resistance to an operation of separating the two, and as a result, the connection between the two is reliably maintained. . Therefore, even when the operation of pulling the plunger 4 in the proximal direction is performed, the plunger 4 does not easily come off the gasket 3. When using the syringe 1, the film 24 is peeled and removed from the tip of the reduced diameter portion 22 to release the sealing, and a hub of a needle tube, for example, is fitted and attached to the reduced diameter portion 2. Next, the plunger 4 is pressed toward the tip. As a result, the gasket 3 connected to the plunger 4 slides in the distal direction in the outer cylinder 2, and the liquid 7 in the outer cylinder 2 flows through the lumen 23 of the reduced diameter portion 22 and the installed needle tube. Exhausted through.

Further, the plunger 4 may be reciprocated a plurality of times in the longitudinal direction so as to discharge the internal liquid 7 without leaving it.

Alternatively, an operation may be performed in which the plunger 4 is pulled in the proximal direction, the liquid is sucked from the distal end opening of the reduced diameter portion 22, and introduced into the syringe 1.

As described above, the preferred embodiment of the syringe of the present invention shown in the attached drawings has been described, but the present invention is not limited to this. In particular, the shapes, structures, dimensions, and the like of the screwing portion, the fitting portion, and the rotation suppressing mechanism can be any ones that can exhibit the same function. Industrial applicability ADVANTAGE OF THE INVENTION According to the syringe of this invention, a plunger and a gasket have sufficient coupling force, assembly is easy, and once a plunger and a gasket are once connected, they cannot be easily removed.

In addition, when the present invention is applied to a prefilled syringe containing a liquid in advance, it is possible to prevent liquid leakage due to deformation of the gasket.

Claims

The scope of the claims

1. A syringe comprising an outer cylinder, a gasket slidable in the outer cylinder, and a plunger for moving the gasket,

The gasket and the plunger are connected by a screwing portion that is connected by screwing screws provided in the gasket interior and the plunger, and a fitting portion that is connected by fitting provided in the gasket interior and the plunger. Syringe.

2. The syringe according to claim 1, wherein the fitting portion is located deeper in the gasket than the screw portion.

3. When the plunger and the gasket are connected, the plunger moves to enter the gasket while rotating by the action of the screwing portion, and the fitting portion is fitted by this movement. The syringe according to claim 1.

4. The syringe according to claim 1, wherein, when connecting the plunger and the gasket, the screwing of the screwing portion and the fitting of the fitting portion are completed substantially simultaneously.

5. The fitting portion according to any one of claims 1 to 4, wherein the fitting portion has at least one elastic piece provided on the plunger, and a protrusion formed on the elastic piece and capable of engaging with the gasket. The syringe as described.

6. The syringe according to any one of claims 1 to 5, wherein the fitting portion has a sliding surface for facilitating an operation leading to fitting.

7. The syringe according to claim 6, wherein the driving surface is a curved surface or a tapered surface.

8. The syringe according to any one of claims 1 to 7, wherein a liquid is stored in a space surrounded by the outer cylinder and the gasket.

9. The syringe according to claim 8, wherein the syringe is configured so that the liquid does not leak due to deformation of the gasket accompanying connection of the plunger and the gasket.