JPH08164205A - Prefilled syringe and gasket falling-off preventing jig and sterilization method using the jig - Google Patents

Abstract

PURPOSE: To prevent falling-off of a gasket and leakage of a liquid medicine or the like without inhibiting sliding property of the gasket during high pressure steam sterilization, by arranging a presser which is fixed on the inner face of the outer syringe on the other end face of the gasket inserted into the syringe in a prefilled syringe. CONSTITUTION: A prefilled syringe 1 is manufactured in such a manner that a nozzle 4 and an open part 3 are respectively provided on one side and the other side of a cylindrical-shaped outer syringe 2, a cap 5 is attached to the nozzle 4, a gasket 6 is inserted from the open part 3 of the other side to seal a liquid medicine inside the syringe. A presser 9 which is fixed on the inner face of the outer syringe 2 is arranged on the other side of the gasket 6. Thereby, falling-off of the gasket 6 can be prevented because the liquid medicine filled in the inner part of the outer syringe 2 is prevented from moving toward the other side of the gasket by means of the presser even when the gasket 6 is pushed toward the other side due to inner pressure during high presser steam sterilization or the like. A close contact property between the outer syringe 2 and the gasket 6 is not necessary to be so much increased.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a means for preventing a gasket from falling off due to an increase in internal pressure of a drug solution in a prefilled (prefilled) syringe prefilled with the drug solution.

[0002]

2. Description of the Related Art As shown in FIG. 24, a prefilled syringe 100 has one end 101 side (left side in the illustrated example).
The nozzle 102 is provided in the inner side of the cylindrical outer cylinder 105 in which a flange 104 is formed on the other end 103 side (right side in the illustrated example) that is open. A gasket 107 is inserted from the other end 103 side of the cylinder 105, and a cap 108 is attached to the nozzle 102.
Is attached. Regarding such a prefilled syringe, conventionally, it has been conventionally put into practice.
No. "Syringe also used as a container", No. 3-9753 "Syringe also used as a container" and the like are disclosed. Each of these syringes has a structure in which a gasket made of an elastic material is inserted from the rear end of the outer cylinder to seal the drug solution inside.

It is desirable that the prefilled syringe as described above is heat-sterilized by an autoclave or the like in a state in which a drug solution is filled therein. During this heat sterilization, the gasket may be pushed out by the internal pressure of the heated chemical solution and may come out of the outer cylinder, or the high-pressure chemical solution may leak between the gasket peripheral surface and the inner surface of the outer cylinder. There is. In order to solve such problems as the gasket coming off and the leakage of the chemical liquid, in the conventional prefilled syringe, a means for improving the adhesiveness with the inner surface of the outer cylinder is devised by devising the shape of the gasket variously. .

[0004]

However, if the adhesion between the peripheral surface of the gasket and the inner surface of the outer cylinder is improved, the problems such as the gasket coming off and the leakage of the chemical solution can be solved. On the other hand, when the syringe is used, the gasket is not used. There is a drawback that the force required to push out the syringe becomes large and the usability of the syringe becomes poor. Particularly in a prefilled syringe filled with a high-viscosity, high-volume liquid such as a blood vessel contrast agent, it becomes difficult for human power to push out the gasket, and it becomes more difficult for the injection conditions inside the body to become constant. Therefore, it is difficult to obtain an accurate image, so an expensive power injector has to be used.

Therefore, it is an object of the present invention to solve the problems such as the gasket coming off and the leakage of chemicals during high-pressure steam sterilization without impairing the sliding property of the gasket in the prefilled syringe.

[0006]

According to the present invention, as described above, a prefilled gasket in which a gasket is inserted from the other end side of an outer cylinder having a nozzle provided at one end side and an opening portion provided at the other end side. In a syringe, there is provided a prefilled syringe having the following configuration, which is excellent in preventing the gasket from coming off.

According to a first aspect of the present invention, the retainer fixed to the inner surface of the outer cylinder is disposed on the other end side of the gasket. According to a second aspect of the present invention, a retainer made of an elastic material that can be crimped inside the outer cylinder is formed on the other end side of the gasket. According to a third aspect of the present invention, a retainer having a stopper portion that is engageable with and disengageable from the flange is disposed on the other end side of the gasket. According to a fourth aspect of the present invention, a stopper portion that is detachable from the flange is formed on the other end side of the gasket.
The prefilled syringe according to claim 5, wherein the gasket is made of an elastic material, and a screw hole is formed in the other end side surface of the gasket, and a taper screw is screwed into the screw hole. Thus, the gasket is crimped to the inside of the outer cylinder. According to a sixth aspect of the present invention, the gasket is made of an elastic material, and a protrusion is formed on the inner surface of the outer cylinder. Claim 7
In this case, the gasket is made of an elastic material, a step portion is formed on the inner surface of the outer cylinder, and the step portion and the outer edge portion of the other end side surface of the gasket engage with each other when the gasket is inserted. Is characterized by. According to an eighth aspect of the present invention, the gasket is made of an elastic material, and a buffer portion for releasing the internal pressure of the syringe is formed at one end of the gasket. According to a ninth aspect of the present invention, a holding tool including a folding piece that can be attached to the outer surface of the outer cylinder is arranged on the other end side of the gasket.

The prefilled syringe according to any one of claims 1 to 9, which further comprises the above-mentioned features, further comprising: 1 on the outer peripheral surface of the outer cylinder.
Alternatively, it is possible to form two or more reinforcing ribs.

Further, according to the present invention, as described above, the inside of the outer cylinder having the nozzle provided at one end and the flange formed at the other end is filled with the chemical liquid, and the other end of the outer cylinder is filled. A gasket is inserted from the side and a cap is attached to the nozzle. As a means for preventing the gasket from coming off in the prefilled syringe, a spacer arranged on the other end side of the gasket inside the outer cylinder and a flange The other end side pressing member that is in contact with the end side and prevents the spacer from coming out of the outer cylinder, one end side pressing member that is in contact with one end side of the flange, and the other end side pressing member Also provided is a gasket removal preventing jig, which is characterized by comprising a fastener that holds a state in which the flange is clamped by the one end side pressing member.

In this jig, the spacer can be provided integrally with the pressing member on the other end side, and a plurality of spacers can be provided. Further, in this jig, the spacer may be provided integrally with the gasket.

The pressing member on one end side of the jig may have a hole through which the outer cylinder can be inserted. Further, a plurality of holes can be provided.

Further, the fastener of this jig can be constituted by screwing means and / or clamping means.

Further, according to the present invention, as a method of sterilizing a prefilled syringe using this jig, a spacer is arranged inside the outer cylinder on the other end side of the gasket and the other end side is formed on the other end side of the flange. Abutting the pressing member, abutting the one end side pressing member to the one end side of the flange,
A step of attaching these jigs to the prefilled syringe by fastening the other end side holding member and the one end side holding member with a fastener, and a step of heat sterilizing the prefilled syringe on which the jig is attached A sterilization method is provided.

In this sterilization method, heat sterilization can be performed by an autoclave.

[0015]

According to the prefilled syringe of the present invention, the movement of the gasket to the rear is prevented by using the retainer or the like.

In the gasket removal prevention jig of the present invention, a spacer is arranged inside the outer cylinder on the other end side of the gasket, the other end side pressing member is brought into contact with the other end side of the flange, and the flange is formed. The jig can be attached to the prefilled syringe by bringing one end side pressing member into contact with one end side and fastening the other end side pressing member and the one end side pressing member with a fastener. In the prefilled syringe with the jig attached in this way, the flange formed on the other end side of the outer cylinder is firmly sandwiched from both sides by the other end side holding member and the one end side holding member, and the spacer is inside the outer cylinder. Since it is in the state of being inserted and arranged in, it is possible to reliably suppress the movement of the gasket to the other end side. Therefore, even when the prefilled syringe equipped with the jig of the present invention is heat sterilized by, for example, an autoclave, the problem that the gasket is pushed out by the internal pressure of the chemical does not occur at all.

[0017]

Embodiments of the present invention will be described below. FIG. 1 shows a prefilled syringe 1 according to an embodiment of the invention of claim 1.
Indicates. Similar to that described with reference to FIG. 24, the open portion 3 is provided on the other end side (right side in the illustrated example) of the outer cylinder 2 having a cylindrical shape, and on one end side (left side in the illustrated example) of the outer cylinder 2. A nozzle 4 is provided. Then, the cap 5 is attached to the nozzle 4, and the gasket 6 is inserted from the opening 3 on the other end side of the outer cylinder 2 to seal the drug solution inside, whereby the prefilled syringe 1 is manufactured. A flange 7 is generally formed on the outer peripheral portion on the other end side of the outer cylinder 2 as shown in the drawing. Further, the gasket 6 is usually made of an elastic material such as rubber, and a hole 8 that can be connected to a handle (plunger) is formed in the other end side surface of the gasket 6. When the prefilled syringe 1 is used, the cap 5 is removed, a tube is attached to the nozzle 4, and a handle (plunger) (not shown) is inserted from the open portion 3 on the other end side of the outer cylinder 2 to remove the handle. Fix the tip of the (plunger) to the hole 8 on the rear surface of the gasket 6,
By pushing the handle (plunger), the drug solution filled inside is supplied through the tube.

The prefilled syringe 1 of the present embodiment is characterized in that the retainer 9 fixed to the inner surface of the outer cylinder 2 is arranged on the other end side of the gasket 6. The presser 9 may have a size such that the outer peripheral surface thereof closely fits the inner surface of the outer cylinder 2, and the presser 9 is, as shown in the drawing,
It may have a ring shape having an outer diameter d slightly larger than the inner diameter D of the outer cylinder 2. Further, the thickness of the presser 9 is
There is no particular limitation. In short, it suffices that a step can be formed on the inner surface of the outer cylinder 2 by mounting the pressing tool 9 to prevent the gasket 6 from moving toward the other end side. The thickness of the retainer 9 may be a size that is easy to handle. The material of the retainer 9 is not particularly limited as long as it can withstand sterilization by an autoclave, but an elastic material such as rubber is preferably used. The pressing tool 9 is pushed into the outer tube 2 from the open portion 3 on the other end side of the outer tube 2, and the elasticity presses the pressing tool 9 to the inner surface of the outer tube 2 to press it to the other end side of the gasket 6. It is designed to hinder the movement of people.

According to the prefilled syringe 1 of this embodiment, even if the gasket 6 is pushed to the other end side by the internal pressure of the chemical liquid filled in the outer cylinder 2, it is arranged at the other end side of the outer cylinder 2. Since the pressing member 9 that is present prevents the gasket 6 from moving toward the other end, the problem of the gasket 6 coming off can be solved. Therefore, according to the prefilled syringe 1 of the present embodiment, the peripheral surface of the gasket 6 and the outer cylinder 2 are
It is possible to prevent the gasket 6 from coming off without significantly improving the adhesion to the inner surface of the, and at the same time solve the problem of leakage of the chemical solution. Further, if the pressing member 9 is formed in a ring shape as in the present embodiment, the handle can be inserted from the space portion 10 formed in the center of the ring during use, and the pressing member 9 can be attached to the gasket 6 when the handle is mounted. Has the advantage of not getting in the way.

FIG. 2 shows a prefilled syringe 11 according to the second embodiment of the invention. The prefilled syringe 11 of this embodiment is characterized in that a pressing member 13 made of an elastic material is integrally formed on the other end side of the gasket 6. The retainer 13 integrally formed on the other side surface of the gasket 6 has a ring shape having an outer diameter slightly larger than the inner diameter of the outer cylinder 2 as in the embodiment described above with reference to FIG. When inserting the gasket 6 from the rear end of the tube 2, the pressing tool 13 is also pushed into the outer tube 2 and the elasticity of the pressing tool 13 causes the inner surface of the outer tube 2 to be crimped and fixed to the rear side of the gasket 6. Is hindering the movement of

In FIG. 3, the gasket 6 is wholly made of an elastic material such as rubber, and a ring-shaped presser tool 16 that expands in a taper shape from the other end side surface of the gasket 6 toward the rear is integrally formed. It is the formed example. According to this embodiment, the elasticity of the retainer 16 allows the gasket 6 to be prevented from coming off by being crimped and fixed to the inner surface of the outer cylinder 2, and in addition, when the syringe is used, the handle 17 is provided with the central portion of the gasket 6. Is pushed forward, the gasket 6 is entirely bent and deformed so that the outer diameter of the presser tool 16 is contracted. Therefore, there is an advantage that the slidability of the gasket 6 can be secured when the syringe is used.

FIG. 4 shows a prefilled syringe 20 according to the third embodiment of the invention. The prefilled syringe 20 includes a holding tool 22 having a stopper portion 21 that is detachable from a flange 7 formed on the other end side of the outer cylinder 2.
Is arranged on the other end side of the gasket 6. The retainer 22 of the embodiment has a tube-shaped configuration made of an elastic material such as rubber as a whole, and the rear portion (stopper portion 21) of the tube is folded back to cover the flange 7 on the other end side of the outer cylinder 2. As a result, the retainer 22 is fixed to the other end side of the gasket 6, and the movement of the gasket 6 toward the other end side is prevented.

FIG. 5 shows a prefilled syringe 25 according to the fourth embodiment of the invention. The prefilled syringe 25 is characterized in that a stopper portion 26 that is detachable from a flange 7 formed on the other end side of the outer cylinder 2 is integrally formed on the other end side surface of the gasket 6. FIG.
Similarly to the one shown in FIG. 2, the stopper portion 26 of the embodiment has a tube shape made of an elastic material such as rubber as a whole, and the stopper portion 26 is folded back at the other end side of the outer cylinder 2 so that Fix by covering the flange 7 on the other end,
The gasket 6 is configured to prevent the gasket 6 from moving toward the other end. According to this embodiment, by covering the flange 7 on the other end side of the outer cylinder 2 with the stopper portion 26, the gasket 6
In addition to being able to prevent the inner cylinder of the outer cylinder 2 from coming into contact with the outside air, there is an advantage that the sterility of the inner cylinder of the outer cylinder 2 can be improved.

FIG. 6 shows an embodiment in which the other end of the outer cylinder 2 and the other end side surface 31 of the gasket 6 are aligned when the chemical solution is sealed inside the outer cylinder by the gasket 6. . As in the case described above with reference to FIG. 5, the rear surface 31 of the gasket 6 is integrally formed with a stopper portion 32 that is detachable from the flange 7 on the other end side of the outer cylinder 2.
According to this embodiment, in addition to the advantages that the gasket 6 can be prevented from coming off and the sterility of the inner surface of the outer cylinder 2 can be improved as in the previous case, in addition, the gasket 6 can be replaced by the outer cylinder 2.
It has the advantage that it can be easily positioned when it is inserted into.

7 and 8 show a prefilled syringe 35 according to an embodiment of the invention of claim 5. In this prefilled syringe 35, a taper screw 38 is screwed into a screw hole 8 formed on the other end side surface of the gasket 6 made of an elastic material to expand the gasket 6 made of an elastic material to expand the gasket. The feature is that the peripheral surface of 6 is crimped to the inside of the outer cylinder 2. In the prefilled syringe 35 of the present embodiment, the gasket 6 is prevented from coming off by performing sterilization in such a state that the peripheral surface of the gasket 6 is pressure-bonded and fixed to the inside of the outer cylinder 2. Further, when the syringe is used, by pulling out or loosening the taper screw 38, it is possible to return the gasket 6 to its original contracted state by its elasticity, which is advantageous in that excellent slidability can be secured. .

FIG. 9 shows a prefilled syringe 40 according to the sixth embodiment of the invention. The prefilled syringe 40 is characterized in that a protrusion 41 is formed on the inner surface of the outer cylinder 2. In the illustrated example, in addition to the protrusion 41, a recess 43 is formed on the peripheral surface of the gasket 6 made of an elastic material.
Are formed so that the projections 41 and the recesses 43 engage with each other when the gasket 6 is inserted. If the gasket 6 is made of an elastic material such as rubber,
Even if only the protrusion 41 is formed and the recess 43 is omitted, the initial effect can be expected sufficiently. According to this embodiment, there is an effect that the gasket 6 can be prevented from coming off even though it is a relatively simple method, but the effect is further doubled by combining it with the means described in FIGS. 7 and 8. be able to. That is, as shown in FIG. 9, with the projection 41 of the outer cylinder 2 and the recess 43 of the gasket 6 engaged with each other, a taper screw (not shown) is formed in the screw hole 8 on the rear surface of the gasket 6.
By screwing in and pushing out the gasket 6,
The protrusion 41 and the recess 43 can be firmly engaged with each other, and the gasket 6 can be more reliably prevented from coming off when heat sterilized in the autoclave.

FIG. 10 shows a prefilled syringe 45 according to the seventh embodiment of the invention. In this prefilled syringe 45, a step portion 47 is formed on the inner surface of the outer cylinder 2, and the step portion 47 and the outer edge portion 49 of the other end side surface of the gasket 6 are engaged with each other when the gasket 6 made of an elastic material is inserted. It is characterized by such a configuration. According to the prefilled syringe 45 of the present embodiment, the movement of the gasket 6 to the other end side can be reliably prevented by the step portion 47 in this way, and the gasket 6 can be prevented from coming off.

FIG. 11 shows a prefilled syringe 50 according to the embodiment of the invention of claim 8. In this prefilled syringe 50, one end side surface of the gasket 6 made of an elastic material such as rubber is formed relatively thin so that the one end side surface serves as a buffer portion 52 for releasing the internal pressure of the syringe. The feature is that it is configured as follows. According to this embodiment, when the gasket 6 is pushed by the internal pressure of the chemical liquid, the buffer portion 52 is deformed so as to be recessed, so that the force can be released. It may be possible to prevent the gasket 6 from coming off by adopting such a configuration that the force acting on the gasket 6 is reduced.

FIG. 12 shows a prefilled syringe 55 according to the ninth embodiment of the invention. This prefilled syringe 55 is a folding piece 5 that can be attached to the outer surface of the outer cylinder 2.
It is a feature that a retainer 57 having 6 is arranged behind the gasket 6. According to this embodiment, it is also effective when a flange is not provided on the other end side of the outer cylinder 2. As shown in the drawing, it is convenient to form the pulling piece 59 on the other end side surface of the pressing tool 57 because the pressing tool 57 can be easily pulled out.

In order to reinforce the outer cylinder 2 in the prefilled syringe of the present invention described above, it is preferable to form reinforcing ribs 60 on the outer peripheral surface of the outer cylinder 2 as shown in FIG. The reinforcing rib 60 may be formed integrally with the outer cylinder 2, or a ring-shaped reinforcing member manufactured separately may be attached. Further, the reinforcing rib is not limited to one place, and may be provided in two or more places.

Next, an embodiment of the gasket removal preventing jig according to the present invention will be described. In this jig, as described above with reference to FIG. 24, for example, a nozzle 102 is provided on one end 101 side, and a chemical solution 106 is filled inside an outer cylinder 105 having a flange 104 formed on the other end 103 side. The gasket 107 is inserted from the other end 103 side of the outer cylinder 105, and the cap 108 is attached to the nozzle 102 in the prefilled syringe 100.
The present invention relates to means for preventing the slippage of 07. The jig is basically a gasket 1 inside the outer cylinder 105.
07, a spacer 71 arranged on the other end 103 side of the flange 07, and the other end side pressing member 72 that abuts on the other end 103 side of the flange 104 and prevents the spacer 71 from coming out of the outer cylinder 106; It is configured by one end side pressing member 73 that abuts on one end 101 side of 104, and a fastener 74 that holds the flange 104 sandwiched by the other end side pressing member 72 and the one end side pressing member 73.

As shown in FIG. 14, in this embodiment, the other end side pressing member 72 is formed in a flat plate shape, and the one end side pressing member 73 is the other end side pressing member 7.
A plurality of holes 75 are formed in a member having the same flat plate shape as that of No. 2. The materials of the other end side pressing member 72 and the one end side pressing member 73 are not particularly limited,
For example, it can be made of a resin material such as metal, ceramics, or plastic. As the most preferable material of the other end side pressing member 72 and the one end side pressing member 73, a metal, for example, stainless steel such as SUS316L can be cited. These holes 75 formed in the one end side pressing member 73 are provided in the outer cylinder 105 described in FIG.
It is formed in a circular shape with a size that can be inserted,
As will be described later, the outer cylinder 105 of the prefilled syringe 100 is inserted into these holes 75, and the other end 10 of the outer cylinder 105 is inserted.
The flange 104 formed on the third side is configured to be sandwiched by the other end side pressing member 72 and the one end side pressing member 73.

In this embodiment, the spacer 71 is shown in FIG.
As shown in FIG. 5, it has a cylindrical shape with an appropriate size. The height h and the diameter d of this spacer 71 are
Outer cylinder 1 of prefilled syringe 100 shown in FIG.
05, the other end of the gasket 107 inside the outer cylinder 105 may be appropriately determined according to the distance L of the space formed on the other end 103 side of the gasket 107 and the inner diameter D of the outer cylinder 105. It is desirable that the spacer 71 has such a size that it can be easily inserted and arranged on the 103 side.

Then, as shown in FIG. 16, the outer cylinder 105
Inside the gasket 107, the spacer 71 is provided on the other end side.
Prefilled syringe 100 in which
Are respectively inserted into the plurality of holes 75 formed in the one end side pressing member 73 to bring the one end side pressing member 73 into contact with the one end side of the flange 104 and press the other end side to the other end side of the flange 104. The jig is attached to the prefilled syringe 100 by bringing the members 72 into contact with each other and fastening the other end side holding member 72 and the one end side holding member 73 with the fastener 74 described below.

The fastener 74 is constituted by screwing means as shown in FIG. 17, for example. That is, holes 76 and 77 are formed in the other-side pressing member 72 and the one-side pressing member 73 at positions corresponding to each other, and the holes 76 and 77 are provided from one side of the other-side pressing member 72 or the one-side pressing member 73. A nut 79 is screwed onto the bolt 78 passed through. In this way, by tightening the bolt 78 and the nut 79 from both sides, the other end side pressing member 72 and the one end side pressing member 73 firmly sandwich the flange 104 from both sides, and the jig of the embodiment of the present invention is attached to the prefilled syringe 100. Can be installed. Accordingly, it is possible to reliably suppress the movement of the gasket 107 toward the other end side by using the spacer 71 inserted and arranged inside the outer cylinder 105. The nut 79 can be omitted by forming one of the holes 76 and 77 as a screw hole.

Further, the fastener 74 may be constituted by a clamp means as shown in FIG. That is, as shown in the drawing, the other end side holding member 72 and the one end side holding member 73
The clamp device 80 is attached from both sides of the
It is also possible to mount the jig of the embodiment of the present invention on the prefilled syringe 100 by clamping the flange 104 between the other end side pressing member 72 and the one end side pressing member 73 by tightening 1.

FIG. 19 is a perspective view showing a state in which the jig of the embodiment of the present invention is mounted on the prefilled syringe 100 by using the fastener 74 constituted by the screwing means. In the prefilled syringe 100 to which the jig is mounted in this manner, the flange 104 formed on the other end side of the outer cylinder 105 is firmly sandwiched from both sides by the other end side pressing member 72 and the one end side pressing member 73, The state where the spacer 71 is inserted and arranged inside the outer cylinder 105 is maintained, and the movement of the gasket 107 to the other end side can be surely suppressed.

Then, the prefilled syringe 100 having the jig of this embodiment attached thereto is then heat-sterilized by, for example, an autoclave. Here, when the autoclave is used, the chemical liquid 10 inside the outer cylinder 105 is
6 is heated to, for example, about 120 to 125 ° C., so that the inside of the outer cylinder 105 has a considerably high pressure. Thus, the prefilled syringe 100 equipped with the jig of the example.
According to this, even when the inside of the outer cylinder 105 has a considerably high pressure in this way, the movement of the gasket 107 to the other end side can be surely suppressed, and the problem that the gasket 107 comes out of the outer cylinder can be ensured. It is possible to solve it.

Next, FIG. 20 shows an embodiment in which a plurality of spacers 71 are integrally provided on the pressing member 72 on the other end side. The height and diameter of the spacer 71 provided integrally with the other end side pressing member 72 are the same as those of the spacer 71 of the embodiment shown in FIG.
The other end 1 of the gasket 107 inside the outer cylinder 105
It is formed in a size that can be easily inserted and arranged on the 03 side. The height of the spacer 71 is preferably equal to the distance between the surface on the other end side of the gasket 107 and the other end 103 of the outer cylinder 105. Further, the diameter of the spacer 71 is the outer cylinder 105.
It is preferable that the inner diameter is approximately equal to the inner diameter. In short, the shape of the spacer 71 is the shape of the gasket 1 inside the outer cylinder 105.
Most preferably, the space formed on the other end side of 07 is completely filled. In addition, the one end side pressing member 73
Is a configuration in which a plurality of holes 75 are formed in a member having a flat plate shape, just like the embodiment shown in FIG. 14, and the holes 75 have a size that allows the outer cylinder 105 of the prefilled syringe 100 to be inserted therethrough. Is formed in a circular shape.

In the jig of this embodiment, as shown in FIG. 21, the spacer 71 is inserted into the other end of the gasket 107 inside the outer cylinder 105 while the other end is attached to the other end of the flange 104. The side pressing member 72 is brought into contact with the outer cylinder 105 of the prefilled syringe 100.
Are inserted into the plurality of holes 75 formed in the one end side pressing member 73, and the one end side pressing member 73 is brought into contact with one end side of the flange 104. In this way, the flange 104 is sandwiched between the pressing member 72 on the other end side and the pressing member 73 on the one end side, and is fastened by the fastener 74 similar to that described above with reference to FIGS. It is possible to attach.

Next, FIG. 22 shows an embodiment in which a spacer 71 is integrally provided on the other end side of the gasket 107. The height and diameter of the spacer 71 integrally formed with the gasket 107 are the same as those of the spacer 71 of the embodiment shown in FIGS. 14 and 21, and the gasket 107 is inserted into the outer cylinder 105 of the prefilled syringe 100. It is structured so that it does not get in the way. Also,
Although not shown in the drawing, the one end side pressing member 73 is first shown in FIG.
Just like the embodiment shown in FIG. 21, a plurality of holes 75 are formed in a member having a flat plate shape.
Is formed in a circular shape having a size capable of inserting the outer cylinder 105 of the prefilled syringe 100.

In the jig of this embodiment, the other end 10 of the outer cylinder 105 is used when manufacturing the prefilled syringe 100.
When the gasket 107 is inserted from the 3 side, the spacer 71 is also integrally pushed into the outer cylinder 105.
Then, in such a state that the spacer 71 is already inserted and arranged in the outer cylinder 105, the other end side pressing member 72 is brought into contact with the other end side of the flange 104 as shown in FIG. The flange 104 is inserted into the plurality of holes 75 formed in the one end side pressing member 73, respectively.
One end side pressing member 73 is brought into contact with one end side of. In this way, the flange 104 is sandwiched between the other end side pressing member 72 and the one end side pressing member 73, and is fastened by the fastener 74 similar to that described in FIGS.
A jig can be attached to the prefilled syringe 100.

[0043]

According to the prefilled syringe of the present invention, it is possible to solve the problems of the gasket coming off and the leakage of the chemical liquid without impairing the sliding property of the gasket.

Further, by using the jig of the present invention, even when the inside of the outer cylinder becomes considerably high pressure when the chemical solution is sterilized by heating,
It is possible to reliably suppress the movement of the gasket to the other end side, and thus it is possible to reliably eliminate the problem of the gasket coming out of the outer cylinder.

[Brief description of drawings]

FIG. 1 is a sectional view showing a prefilled syringe according to an embodiment of the present invention.

FIG. 2 is a sectional view showing a prefilled syringe according to an embodiment of the invention of claim 2;

FIG. 3 is a cross-sectional view showing a prefilled syringe according to an embodiment of the invention of claim 2 in which the pressing member is formed in a tapered shape.

FIG. 4 is a sectional view showing a prefilled syringe according to an embodiment of the invention of claim 3;

FIG. 5 is a sectional view showing a prefilled syringe according to an embodiment of the invention of claim 4;

FIG. 6 is a cross-sectional view showing a prefilled syringe according to an embodiment of the invention of claim 4, wherein the rear end of the outer cylinder and the rear surface of the gasket are aligned with each other.

FIG. 7 is a sectional view showing a prefilled syringe according to an embodiment of the invention of claim 5;

FIG. 8 is a cross-sectional view showing a prefilled syringe according to an embodiment of the invention of claim 5 in which a taper screw is screwed in.

FIG. 9 is a sectional view showing a prefilled syringe according to an embodiment of the invention of claim 6;

FIG. 10 is a sectional view showing a prefilled syringe according to an embodiment of the invention of claim 7;

FIG. 11 is a sectional view showing a prefilled syringe according to an embodiment of the invention of claim 8;

FIG. 12 is a sectional view showing a prefilled syringe according to an embodiment of the present invention.

FIG. 13 is a sectional view showing a prefilled syringe according to an embodiment of the invention of claim 10;

FIG. 14 is a perspective view of the other end side pressing member and the one end side pressing member according to the gasket removal prevention jig of the embodiment of the present invention.

FIG. 15 is a perspective view of a spacer according to the gasket removal prevention jig of the embodiment of the present invention.

FIG. 16 is a cross-sectional view showing a state where the gasket removal prevention jig of the embodiment of the present invention is attached to a prefilled syringe.

FIG. 17 is a view showing an example of a fastener configured by screwing means.

FIG. 18 is a view showing an example of a fastener constituted by a clamp means.

FIG. 19 is a perspective view showing a state in which the jig of the embodiment of the present invention equipped with a fastener composed of a screwing means is mounted on a prefilled syringe.

FIG. 20 is a perspective view of the other end side holding member and the one end side holding member according to the embodiment in which a plurality of spacers are integrally provided on the other end side holding member.

FIG. 21 is a cross-sectional view showing a state where the gasket removal prevention jig of the embodiment of FIG. 7 is mounted on a prefilled syringe.

FIG. 22 is a perspective view of the other-end-side pressing member and the one-end-side pressing member according to the embodiment in which the spacer is integrally provided on the other end side of the gasket.

FIG. 23 is a cross-sectional view showing a state where the gasket removal prevention jig of the embodiment of FIG. 9 is attached to a prefilled syringe.

FIG. 24 is a sectional view of a prefilled syringe.

[Explanation of symbols]

1, 11, 15, 20, 25, 35, 40, 45, 5
0, 55, 100 Prefilled syringe 2, 105 Outer cylinder 3 Opening part 4, 102 Nozzle 5, 108 Cap 6, 107 Gasket 7, 104 Flange 8 Screw hole 9, 13, 16, 22, 57 Presser 21, 26, 32 Stopper part 41 Protrusion 47 Step part 52 Buffer part 56 Folding piece 60 Reinforcing rib 71 Spacer 72 Other end side holding member 73 One end side holding member 74 Fastener

Claims (19)

[Claims] 1. A prefilled syringe in which a gasket is inserted from the other end side of an outer cylinder having a nozzle provided at one end side and an opening portion provided at the other end side, and a retainer fixed to the inner surface of the outer cylinder. A prefilled syringe, wherein the tool is arranged on the other end side of the gasket. 2. A prefilled syringe in which a nozzle is provided at one end side, an opening is provided at the other end side, and a gasket is inserted from the other end side of an outer cylinder filled with a drug solution in the inner surface of the outer cylinder. A prefilled syringe characterized in that a pressing tool made of an elastic material that can be crimped to is formed on the other end side of the gasket. 3. A prefilled syringe in which a nozzle is provided at one end side, a flange is formed at the opened other end side, and a gasket is inserted from the other end side of an outer cylinder filled with a drug solution inside the flange. A prefilled syringe characterized in that a retainer having a stopper part that can be engaged and disengaged with is disposed on the other end side of the gasket. 4. A prefilled syringe in which a nozzle is provided at one end side, a flange is formed at the opened other end side, and a gasket is inserted from the other end side of an outer cylinder filled with a chemical solution inside the flange. A prefilled syringe characterized in that a stopper part which can be engaged and disengaged with is formed on the other end side of the gasket. 5. A nozzle is provided at one end side, an open portion is provided at the other end side, and is made of an elastic material from the other end side of an outer cylinder filled with a chemical solution inside, and at the other end side. A prefilled syringe in which a gasket having a screw hole is inserted, wherein the gasket is crimped to the inside of the outer cylinder by inserting a taper screw into the screw hole. 6. A pre-filled product in which a gasket made of an elastic material is inserted from the other end side of an outer cylinder in which a nozzle is provided at one end side and an open portion is provided at the other end side, and a chemical solution is filled inside the outer cylinder. A prefilled syringe characterized in that a projection is formed on the inner surface of an outer cylinder of the syringe. 7. A prefilled product having a nozzle provided at one end side, an opening provided at the other end side, and a gasket made of an elastic material inserted from the other end side of an outer cylinder filled with a chemical solution inside. In the syringe, a stepped portion is formed on an inner surface of an outer cylinder, and the stepped portion and an outer edge portion of a rear surface of the gasket engage with each other when the gasket is inserted. 8. A prefilled product having a nozzle provided on one end side and an open part provided on the other end side, and a gasket made of an elastic material inserted from the other end side of an outer cylinder filled with a chemical solution inside. A prefilled syringe, characterized in that, in the syringe, a buffer portion is formed on one end side of the gasket for releasing the internal pressure of the chemical liquid. 9. A prefilled syringe in which a nozzle is provided at one end side, an opening is provided at the other end side, and a gasket is inserted from the other end side of an outer cylinder filled with a drug solution inside, the outer surface of the outer cylinder. A prefilled syringe, characterized in that a presser having a folding piece attachable to is disposed on the other end side of the gasket. 10. The prefilled syringe according to claim 1, wherein one or more reinforcing ribs are formed on the outer peripheral surface of the outer cylinder. 11. A nozzle is provided on one end side and a flange is formed on the other end side to fill the inside of an outer cylinder with a chemical liquid, and a gasket is inserted from the other end side of the outer cylinder to the nozzle. Is for preventing the gasket from coming off in the prefilled syringe with the cap attached, and is in contact with the spacer arranged on the other end side of the gasket inside the outer cylinder and the other end side of the flange. , The other end side pressing member that prevents the spacer from coming out of the outer cylinder, the one end side pressing member that abuts on one end side of the flange, and the other end side pressing member and the one end side pressing member. A jig for preventing the gasket from coming off in a prefilled syringe, comprising a fastener that holds the flange in a clamped state. 12. The jig for preventing a gasket from coming off in a prefilled syringe according to claim 11, wherein the spacer is integrally provided on the other end side pressing member. 13. The gasket removal prevention jig in a prefilled syringe according to claim 11, wherein a plurality of the spacers are provided. 14. The jig for preventing removal of a gasket in a prefilled syringe according to claim 11, wherein the spacer is provided integrally with the gasket. 15. The one end side pressing member is provided with a hole through which the outer cylinder is inserted.
A jig for preventing the gasket from coming off in the prefilled syringe according to any one of 1 to 14. 16. The jig for preventing a gasket from coming off in a prefilled syringe according to claim 15, wherein the jig is provided with a plurality of the holes. 17. The fastener according to claim 1, wherein the fastener comprises a screwing means and / or a clamping means.
The jig for preventing the gasket from coming off in the prefilled syringe according to any one of 1 to 16. 18. A nozzle is provided at one end side, and a chemical liquid is filled inside an outer cylinder having a flange formed at the other end side, and a gasket is inserted from the other end side of the outer cylinder to provide a nozzle. Is a method for sterilizing a prefilled syringe with a cap attached thereto by using the jig according to any one of claims 11 to 17, wherein a spacer is arranged on the other end side of the gasket inside the outer cylinder. Then, the other end side pressing member is brought into contact with the other end side of the flange, the one end side holding member is brought into contact with the one end side of the flange, and the other end side holding member and the one end side holding member are fastened by a fastener. A step of mounting the jig according to any one of claims 11 to 17 on a prefilled syringe by fastening, and a step of heat sterilizing the prefilled syringe on which the jig is mounted. A sterilization method comprising: 19. The sterilization method according to claim 18, wherein the heat sterilization is performed by an autoclave.