JP2911086B2 - Prefilled syringe - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION The present invention relates to a syringe-type container comprising a plurality of components, that is, a solid or liquid drug such as powder, microcapsules, granules and tablets, and a solution or dispersion thereof or another drug solution. Relates to so-called prefilled syringes, each of which is pre-filled in a separate chamber of the container.

[0002]

2. Description of the Related Art Among disposable syringes pre-filled with a drug, so-called prefilled syringes,
Conventionally, in a two-component prefilled syringe filled with a predetermined drug and a solution or dispersion thereof or another drug solution separated, an injection needle is conventionally provided at the tip as shown in a sectional view of FIG. A plunger 32 with a rod is inserted from the rear end side of the cylindrical container 31 having the mounting portion, and a movable seal member 33 which is slidable in the axial direction is provided in the container 31 so that the front and rear end sides are provided. There is a first chamber 34 and a second chamber 35, each of which has a structure accommodating a drug or a solution therein (Japanese Patent Publication No. 49-14465).

In this type, the movable seal member 3
In the first chamber 34 on the distal end side from the top of FIG. 3, a discontinuous portion, usually an injection groove 36 protruding outward, is provided on the side wall of the container 31, and the plunger 32 is pushed in during use, as shown in FIG. The movable seal member 33 is advanced through the liquid in the second chamber 35 as described above, and when the movable seal member 33 approaches the injection groove 36, the liquid in the second chamber 35 is It is made to flow into the one room 34. Then, the liquid in the second chamber 35 is almost completely
At the time of flowing into 4, the two components are uniformly dissolved, dispersed or mixed in the first chamber 34 by shaking a syringe or the like,
After that, the movable seal member 33 is pressed by the tip of the plunger 32 to push out the liquid after being dissolved, dispersed or mixed in the first chamber 34 from the tip.

The movable seal member 33 has a diameter slightly larger than the inner diameter of the container 31, and usually has a structure having a plurality of circular ribs 33a to reduce resistance during sliding. The liquid tightness between the second chambers 35 is maintained, and the container 3
The slidability within 1 is considered to be good. The same applies to the sealing member of the plunger 32, in which a plurality of circular ribs 32a are formed.

[0005]

By the way, in the conventional two-component prefilled syringe having the above-described structure, when the liquid in the second chamber 35 passes through the injection groove 36 by the pressing of the plunger 32, the injection groove is formed. As shown in FIG. 8, the liquid accumulates in the annular recess G formed between the circular ribs 33a and 32a in the movable seal member 33 or the seal member of the plunger 32, and the injection liquid is administered by that amount. There is a problem that it is lost without being done.

A main object of the present invention is to provide a prefilled syringe capable of reducing the amount of injection solution loss, and another object of the present invention is to provide a plurality of components before administration to a living body. An object of the present invention is to provide a pre-filled syringe that can reliably perform an operation of uniformly dissolving, dispersing, or mixing.

[0007]

The feature of the present invention is that a first chamber 4 and a second chamber 5 are divided in a cylindrical container 1 as shown in FIGS. A plurality of vertical ribs 301 having substantially the same height as the respective circular ribs 300 and partitioning an annular recess G formed between the respective circular ribs 300 are provided between the respective circular ribs 300 of the movable seal member 3. It has been formed. Here, the substantially equivalent height includes not only a case where the vertical rib 301 is higher and lower than the circular rib 300 by a predetermined dimension, but also a case where the vertical rib 301 has exactly the same height.

[0008] Further, such a sealing structure in which the circular rib 300 and the vertical rib 301 are combined can be similarly applied to the sealing member 2a of the plunger 2 (see FIG. 3). The depth of the recess formed between the movable sealing member 3 and each circular rib 300 of the sealing member 2a of the plunger 2 is preferably as small as possible as long as the sliding property of the sealing member 3 or 2a is not impaired.

Further, between the cylindrical container 1 and the plunger 2, the distal end of the movable seal member 3 reaches forward from the distal end of the discontinuous portion 6 by pressing the plunger 2, and the movable seal member 3 At a position where the rear end surface is in contact with the front end surface of the plunger 2 and at least the rear half of the sealing member 2 a of the plunger 2 does not enter the discontinuous portion 6 and maintains a sliding state with respect to the inner wall of the cylindrical container 1. It is preferable to provide a locking mechanism and a release mechanism for temporarily stopping the plunger 2. In addition, it is of course possible to stop at a position where only the front end or only the rear end of the discontinuous portion 6 is closed.

Here, in the prefilled syringe of the present invention, a plunger is inserted from the rear end of a cylindrical container to which an injection needle can be attached at the distal end, and is movable between the distal end of the cylindrical container and the distal end of the plunger. Although the sealing member is inserted, the distal end portion of the cylindrical container referred to in the present specification truly includes the distal end of the container and the inside at a distance from the distal end of the container. Simply referred to as the tip portion.

[0011]

Each recess G is divided into a plurality of gaps by the vertical ribs 301. When the movable seal member 3 passes through the injection groove 6, the injection liquid stored therein is directly injected into each recess G. Although it enters into the gap communicating with the groove 6,
It is impossible to penetrate into other gaps beyond the vertical rib 301, so that the loss of the injection solution is reduced accordingly.

If a structure in which a circular rib 300 and a vertical rib 301 are similarly combined is adopted for the seal member 2a of the plunger 2, the loss of the injection solution due to accumulation in the gap of the seal member 2a can be reduced. .

A locking mechanism between the plunger 2 and the cylindrical container 1 and a releasing mechanism thereof have a function of facilitating an operation for ensuring mixing or dispersion of the two components before administration. That is, in the actual administration of the injection solution, the first
The liquid in the second chamber 5 is almost completely injected into the first chamber 4 so that the medicine in the chamber 4 and the liquid in the second chamber 5 are uniformly dispersed or mixed. The syringe must be shaken in a state where the liquid does not flow out of the second chamber 5.
When the front surface of the movable seal member 3 comes into contact with the front surface of the plunger 2 in a state where the front end surface of the movable seal member 3 is stopped short of the front end portion of the discontinuous portion 6, the liquid in the first chamber 4 is substantially removed. Injected all the way. Therefore, by pressing the plunger 2, at least the front end of the movable seal member 3 reaches forward from the front end of the discontinuous portion 6, the front surface of the plunger 2 reaches the rear surface of the movable seal member 3, and the second half of the plunger 2. By providing a locking mechanism for temporarily stopping the plunger 2 at a position where the portion does not enter the discontinuous portion 6 and keeps the inner wall of the tubular container 1 slidable, the movable seal member 3 can be prevented from going too far. In addition, the above-described operation before administration can be ensured without the outflow of the lysate, and by releasing the lock by the release mechanism, administration to the living body becomes possible.

[0014]

1 is a longitudinal sectional view of an embodiment of the present invention, and FIG. 2 is an external perspective view of a movable seal member 3.

A plunger 2 with a rod is provided with a sealing member 2a fixedly or removably mounted on the distal end of a rod 2b, with the rear end side of the cylindrical container 1 having a syringe needle mounting portion 10 formed at the distal end open all over. Is inserted. This cylindrical container 1
, A movable seal member 3 is inserted between the tip of the plunger 2 and the tip of the plunger 2. The movable seal member 3 divides the inside of the cylindrical container 1 into a first chamber 4 and a second chamber 5 in a liquid-tight manner. Have been. In the first chamber 4, fixed or liquid drugs such as powders, microcapsules, granules, and tablets are stored, and in the second chamber 5, for example, distilled water for injection, a solution such as physiological saline, a dispersion or An injection groove 6 having a predetermined width and projecting outward is formed on the side wall of the first chamber 4 of the cylindrical container 1 while accommodating another chemical solution. Of the movable seal member 3 is longer than the thickness of the movable seal member 3 by a predetermined amount. The total axial length of the movable seal member 3 and the seal member 2 a of the plunger 2 is longer than the axial length of the injection groove 6.

In the storage state, a suitable sealing member is attached to the distal end of the cylindrical container 1, and the plunger 2 with a rod is mounted.
The displacement regulating member is also mounted. The above is the same as the conventional structure, and the movable seal member 3 is also provided with a plurality of circular ribs 300 in order to reduce the resistance when sliding inside the cylindrical container 1.

The feature of this embodiment is that a plurality of vertical ribs 301 having substantially the same height as these are formed between the circular ribs 300 of the movable seal member 3. The gap G is an annular recess formed between the circular ribs 300 and is divided into a plurality of small gaps.

In this example, the outer periphery of the movable seal member 3 is
In each of the gaps G, four vertical ribs 3
Thus, each gap G is divided into four equal parts.

When the above embodiment of the present invention is used, the plunger 2 with rod is pressed to the distal end side as in the prior art, whereby the movable seal member 3 advances through the liquid in the second chamber 5 and the movable seal member 3 is moved forward. When the member 3 reaches the position where the injection groove 6 is formed and the first chamber 4 and the second chamber 5 communicate with each other, the liquid in the second chamber 5 flows into the first chamber 4 and the inflow is completed. After the tip of the plunger 2 has come into contact with the rear end of the movable seal member 3, the plunger 2 is directly pressed to advance the movable seal member 3, and is dissolved, dispersed or dispersed through an injection needle attached to the tip of the cylindrical container 1. Inject the mixed injection.

At this time, the injection liquid after dissolving, dispersing or mixing enters into any one of the small spaces among the circular ribs 300 of the movable seal member 3 through the injection groove 6.
Due to the presence of the vertical rib 301, the adjacent small space cannot enter, so that in this example, the amount of the injection solution remaining in the space G of the movable seal member 3 becomes about 1/4 of the conventional amount.

In the above-described dosing operation, the injection solution may enter the gap between the circular ribs of the seal member 2a at the tip of the plunger 2 with the rod similarly, causing a loss. The embodiment shown in FIG. 3 solves this point.

That is, in the example of FIG. 3, the sealing member 2a of the plunger 2 with a rod is also shown in FIG.
The structure exactly the same as that shown in FIG.
The height of each circular rib 3
A plurality of vertical ribs 301 are formed to partition an annular space formed between 00, and the annular space is divided into a plurality of small spaces.

According to the example of FIG. 3, the movable seal member 3
Not only the sealing member 2a of the plunger 2 with a rod
Comes to the position where the injection groove 6 is formed,
The injection liquid enters only into the small gap communicating with the opening, but does not enter the adjacent small gap, and the amount of the injection liquid remaining in the gap and causing loss can be further reduced.

The number of the vertical ribs 301 provided in the space between the circular ribs 300 of the movable sealing member 3 and the sealing member 2a of the rod-equipped plunger 2 is not limited to four.
The number of injections can be reduced to an arbitrary number, and the number of injections can be reduced by increasing the number. On the other hand, the slidability of the seal members 3 to 2a decreases accordingly. It is desirable to use the number.

The axial shape of each of the circular rib 300 and the vertical rib 301 of the movable seal member 3 and the seal member 2a of the rod-equipped plunger 2 is linear along the inner wall surface of the cylindrical container 1 as shown in the figure. In addition to the shape, a so-called crowning shape in which a curved bulge is appropriately provided in the axial direction to further reduce the frictional resistance with the cylindrical container 1 can be used.

Here, as the material of the movable seal member 3 and the seal member 2a of the plunger 2 in each of the above embodiments, an elastomer, for example, synthetic rubber can be adopted. The plunger 2 with a rod may have the rod fixed to the seal member 2a,
It may be detachably attached.

In the two-component prefilled syringe, before the actual administration, the plunger 2 with a rod is pressed so as to uniformly dissolve, disperse, or mix the two components in the first chamber 4 and press the second chamber 5. As described above, it is necessary to temporarily stop the plunger 2 in a state in which the liquid in the first chamber 4 has almost completely flowed into the first chamber 4 and has not yet flowed out from the tip of the container 1, and shake the syringe well in that state. When the vibration is applied, the dissolving liquid or the dispersing liquid moved into the first chamber 4 flows back through the injection groove 6 and moves back to the second chamber 5 side, that is, beyond the plunger 2, and the cylindrical container 1 In order to prevent the plunger 2 from flowing out to the rear part, the operation of temporarily stopping the plunger 2 with the rod at an optimum position is not easy without skill, and the plunger 2 may be erroneously overdriven.

FIGS. 4 and 5 show an embodiment in which such an operation is facilitated. In the example shown in FIG. 4, a convex portion 101 is formed on the inner peripheral surface of the finger grip 100 attached to the rear end of the cylindrical container 1 so as to protrude inward from the inner peripheral surface of the cylindrical container 1. At the same time, a plurality of projections 201 are formed on the same circumference at a predetermined position in the axial direction of the rod 2b of the plunger 2 with a rod. The position of each projection 201 in the axial direction of the rod 2b is such that the distal end surface of the movable seal member 3 reaches forward from the distal end portion of the injection groove 6 by pressing the plunger 2, and the rear end surface of the movable seal member 3 In a state in which the protrusion 201 is in contact with the distal end surface of the plunger 2 and at least the rear half of the sealing member 2 a of the plunger 2 does not enter the injection groove 6 and keeps a sliding state with the inner wall of the cylindrical container 1, 100 convex portions 10
1, and the distance between the center axis of the rod 2 b and the tip of each projection 201 is slightly larger than the inner diameter of the projection 101 of the finger grip 100. Further, the material of the finger grip 100 is made of a flexible material such as a synthetic resin.

According to the above configuration, when the plunger 2 with a rod is pushed in from the non-use state of FIG.
While the liquid moves, the movable seal member 3 stops near the tip of the injection groove 6 as shown in (B), but when the liquid is further pushed in, the projection 201 comes into contact with the projection 101 as shown in (C). As a result, the plunger 2 temporarily stops due to the resistance. In this state, the liquid in the second chamber 5 is completely injected into the first chamber 4, and the tip of the movable seal member 3 reaches forward from the tip of the injection groove 6, and the seal member of the plunger 2. The latter half of 2a enters a state in which it does not enter the injection groove 6 and keeps sliding with the inner wall surface of the container 1, and both the front end and the rear end of the injection groove 6 are closed. In this state, the syringe is shaken to uniformly dissolve, disperse or mix the two components. Thereafter, by strongly pushing the plunger 2 with a rod, the finger grip 100 bends and the projection 201 passes through the convex portion 101, so that the injection, after dissolution, dispersion or mixing, can be administered to the living body.

On the other hand, in the example shown in FIG. 5, a convex portion 101 is similarly formed on the inner peripheral surface of the finger grip 100 attached to the rear end of the cylindrical container 1.
As shown in FIG. 2B, as viewed from the axial direction, a plurality of notches 102 are formed, and the same number of blades 202 are formed in the rod 2b of the plunger 2 with a rod. Each blade 202 from the center of the rod 2b
Is longer than the inner diameter of the convex portion 101 of the finger grip 100 and shorter than the distance between the center of the finger grip 100 and the bottom surface of each cutout groove 102. Further, the end surface position of the front end side of each blade 202 is such that the front end surface of the movable seal member 3 reaches forward from the front end portion of the injection groove 6 by pressing the plunger 2, and the rear end surface of the movable seal member 3 and the plunger 2 is in contact with the end surface of the plunger 2 and the latter half of the sealing member 2a of the plunger 2 does not enter the injection groove 6 and keeps sliding with respect to the inner wall of the container 1. This position is in contact with the rear end face.

In the above configuration, in the state before use shown in (A), each blade 202 of the rod 2b does not coincide with the formation position of the notch groove 102 of the finger grip 100 as shown in (C). It is inserted into the cylindrical container 1 in such a state. Then, at the time of use, the plunger 2 with a rod is first pushed in with the state shown in FIG. Thereby, the liquid starts to move. While the liquid is moving, the tip of the movable seal member 3 stops near the tip of the injection groove 6 as shown in (D). In this state, the tip of the blade 202 is in contact with the finger grip 100. Absent. When the plunger 2 with a rod is further pushed in from this state, the plunger 2 stops when the blade 202 comes into contact with the rear end face of the finger grip 100 as shown in FIG. In this state, the liquid in the second chamber 5 is completely injected into the first chamber 4 and the front and rear ends of the injection groove 6 are closed.
The components are uniformly dissolved, dispersed or mixed. After that, when the plunger 2 with a rod is rotated to make each blade 202 coincide with the formation position of each notch groove 102, (F)
As shown in (1), the plunger 2 with a rod can be pushed, so that the injection solution after dissolution, dispersion or mixing can be injected into a living body.

Note that, without adopting the structure shown in FIG. 4 or FIG. 5 described above, the cylindrical shape at a predetermined position in front of the tip of the injection groove 6, for example, a position about 2 mm ahead of the injection groove 6. It is effective to provide only a line-shaped mark along the circumferential direction on the outer or inner peripheral surface of the container 1. That is, when the plunger 2 is pressed so that the tip end surface of the movable seal member 3 does not exceed the mark, the second chamber 5
Since the liquid in the inside is almost completely injected into the first chamber 4, the syringe may be shaken in this state.

[0033]

As described above, according to the present invention,
A plurality of vertical ribs were formed in an annular space formed between the plurality of circular ribs formed in the movable seal member, and the space was divided into a plurality of small spaces. Even if the injection solution dissolved, dispersed or mixed enters into a small space between each circular rib of the sealing member,
The injection solution cannot penetrate the adjacent small space beyond the longitudinal rib, and therefore, the administration loss of the injection solution is reduced accordingly.

Similarly, the plunger seal member is provided with longitudinal ribs for partitioning the gaps between the circular ribs, thereby reducing the amount of injection liquid that enters the annular gaps of the seal member and causes loss. Can be.

Further, the leading end of the movable seal member substantially reaches the leading end of the discontinuous portion of the cylindrical container by pressing the plunger,
At the position where the rear end face of the movable seal member and the front end face of the plunger abut, and the rear half of the seal member of the plunger does not enter the discontinuous portion and keeps the sliding state with the container inner wall, Is provided with a locking mechanism between the rod of the plunger and the cylindrical container so as to temporarily stop, and by providing a release mechanism, uniform dissolution, dispersion or mixing of a plurality of components prior to administration can be performed. This is facilitated, and at that time, the backflow of the liquid can be prevented.

[Brief description of the drawings]

FIG. 1 is a sectional view of an embodiment of the present invention.

FIG. 2 is an external perspective view of the movable seal member 3.

FIG. 3 is a sectional view of another embodiment of the present invention.

FIG. 4 is a sectional view of still another embodiment of the present invention.

FIG. 5 is a sectional view of still another embodiment of the present invention.

FIG. 6 is a cross-sectional view showing a configuration example of a conventional two-component prefilled syringe.

FIG. 7 is an explanatory diagram of an operation when the device is used.

FIG. 8 is an explanatory view of a residual liquid at the time of administration of a conventional two-component prefilled syringe.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Cylindrical container 10 Injection needle mounting part 100 Finger grip 101 Convex part 102 Notch groove 2 Plunger with rod 2a Seal member 2b Rod 201 Projection 202 Blade 3 Movable seal member 300 Circular rib 301 Vertical rib 4 First chamber 5 Second chamber 6 Injection groove

──────────────────────────────────────────────────続 き Continuation of the front page (56) References JP-A-61-48377 (JP, A) JP-A-5-139977 (JP, A) JP-A-5-86353 (JP, U) 14465 (JP, Y1) (58) Fields investigated (Int. Cl. ⁶ , DB name) A61M 5/178-5/34 A61M 3/00

Claims (5)

(57) [Claims] 1. A plunger is inserted from the rear end side of a cylindrical container to which an injection needle can be attached at a distal end portion, and an axial direction of the container is provided between the distal end portion of the container and the distal end of the plunger. A movable seal member, which is slidable and has a plurality of circular ribs formed on the outer periphery, is inserted, and the interior of the container is divided into a first chamber on the front end side and a second chamber on the rear end side by the seal member. The first chamber contains a medicine, and the second chamber contains a solution, a dispersion, or another chemical. When the movable seal member slides and displaces due to the pressing of the plunger, the first chamber is closed. The liquid in the second chamber flows into the first chamber through the discontinuous portion of the side wall of the chamber to dissolve, disperse, or mix the medicine, and each circular rib of the movable seal member has a circular shape. Has approximately the same height as the ribs, between each circular rib A prefilled syringe comprising a plurality of vertical ribs for partitioning an annular recess to be formed. 2. The sealing member of the plunger has a plurality of circular ribs formed on an outer periphery thereof, and has a height substantially equal to each circular rib between the circular ribs. The prefilled syringe according to claim 1, wherein a plurality of vertical ribs are formed to partition the annular recess formed in the syringe. 3. When the plunger is pressed, the distal end of the movable seal member reaches forward from the distal end of the discontinuous portion of the cylindrical container, and the rear end surface of the movable seal member is the distal end surface of the plunger. At a position where at least the rear half of the seal member of the plunger does not enter the discontinuous portion and maintains a sliding state with respect to the inner wall of the cylindrical container, pushes the plunger so as to temporarily stop the plunger. The prefilled syringe according to claim 1, wherein a locking mechanism is provided between the rod and the cylindrical container, and a release mechanism is provided. 4. A finger grip is mounted near a rear end of the cylindrical container, and the finger grip is formed with a convex portion projecting inward from an inner peripheral surface of the cylindrical container. A projection is formed at a predetermined position in the axial direction of the rod for pushing the plunger, and the projection of the rod and the projection are engaged with each other by pushing the rod to stop the plunger once, and 4. The pre-filled syringe according to claim 3, wherein the engagement is released by further pushing the rod. 5. A finger grip is mounted near a rear end of the cylindrical container, and a convex portion is formed on the finger grip so as to protrude inward from an inner peripheral surface of the cylindrical container. The projection has at least one notch extending in the radial direction, while the rod pushing the plunger has at least one blade extending in the radial direction corresponding to the notch. The blade and the projection are engaged with each other by pushing the rod, and the plunger is temporarily stopped, and the rod is rotated with respect to the cylindrical container to match the position of the notch with the blade. 4. The pre-filled syringe according to claim 3, wherein the blade is configured to pass through the notch and release the engagement when the blade is in a state where the blade is disengaged.