JP3313706B2 - Syringe - Google Patents

Description

The present invention relates to a pre-filled syringe for medical or veterinary medical procedures.

Applicant's published European patent application 029858
No. 5 describes a syringe system based on the concept of "bottomless vial", in which the bottom of a conventional glass pin is replaced by a rubber piston, which is a vial Forming an airtight seal with the walls of the vial and having an extension extending down into the vial and connectable to a syringe plunger.
When the plunger is thus connected to the piston and the adapter is attached to the cap of the vial, the vial is converted to a syringe. The crucial advantage of such bottomless vial-based syringes over conventional syringe systems is that they do not require special expensive filling systems and are generally available and commonly used in the pharmaceutical industry. The ability to sterilize, fill and cap with the vial filling equipment of the present invention, and significantly reduce the number of cleanroom operations required to manufacture products as compared to conventional syringe assembly and filling systems. What you can do. As described in detail in the above patent application, this system is extremely versatile,
This "bottomless vial" forms the basis of a wide range of syringe delivery systems.

The advantage of the above system, i.e. that the vial can be sterilized, filled and capped using a conventional vial filling machine, is identified because the vial must be kept stationary as it passes through the filling machine. In this case, there is a limitation, which limits the allowable height for the vial diameter. This problem is exacerbated by the need to provide a bead around the bottom of the vial. This bead gives the glass the necessary strength and
After filling the vial, the bead is pressed by the bead to form, for example, a means for fixing a syringe component which also serves as a piston retainer, a plunger grip and a plunger guide. Even the smallest bead protrusions interfere with beads and other obstacles in adjacent vials and impair vial stability. In addition, bead formation is limited to prevent ramping effects because the interaction of the beads tends to cause the vial to tip over. Furthermore, providing the vial cap with an adapter requires a clean room operation that was not required during conventional vial filling.

It is generally assumed that the inner surface of the syringe should be smooth and free of obstructions, but at least partially inwardly on the inner surface of the glass body of the vial at the base of the "bottomless vial". Forming a peripheral bead has been found to be beneficial. This makes it possible to reduce or eliminate parts extending outside the peripheral bead,
While improving vial stability, the height to diameter ratio can be increased to some extent. In addition, it has been found that a versatile finger grip and plunger guide that is structurally simple but functionally improved can be used with this modified bead.

Further, it has been found that by incorporating the adapter into the cap structure in a manner that does not interfere with the normal operation of conventional capping machines, the use of a separate adapter can often be omitted.

Other features of the invention are set forth in the appended claims.

For ease of understanding the present invention, please refer to the preferred embodiments described below with reference to the accompanying drawings. In the drawings, FIG. 1 is an exploded perspective view of components of a syringe according to the first embodiment. FIG. 2 is a vertical cross-sectional view of the vial portion of the syringe in a filling preparation state, FIG. 3 is a vertical cross-sectional view of the assembled syringe after discharging the contents, and FIG. FIG. 3 shows the arrangement of FIG. 3 in a modified state.
FIG. 5 is an enlarged schematic longitudinal section of a portion of the syringe of the figure, and FIG. 5 is an enlarged vertical view through a bead of a syringe according to a second embodiment showing the proximity of a modified piston retainer and finger grip. It is sectional drawing.

Referring to FIGS. 1 to 4, the syringe comprises a syringe barrel or vial body in the form of a somewhat longer glass vial 2, the bottom wall of which is connected to the fourth vial.
As best shown in the figure, the reinforcement bead 6 forming a peripheral edge at the bottom of the vial side wall 4 is missing from a slightly inwardly projecting protrusion. In the embodiment shown, the reinforcing bead 6 also has a very slightly outwardly projecting protrusion, but is smaller than would be required if the bead was formed all around the outside of the side wall 4. However, it is also possible to completely omit it. In any case, the outer portion of the protrusion is unsuitable for erecting the vial in very close proximity without sufficient space to tilt. Typically, the protrusion does not exceed approximately one-fifth of the bead thickness. The protrusion of the bead should also be restricted on the inside, so that the head 10 of the molded rubber piston 8 can be inserted into the vial beyond the protrusion (because of the gap between the sealing lands 14 of the head). The plunger guide 16 (hereinafter simply referred to as a finger grip), which also functions as an integrated finger grip and a piston stopper, is tightly fitted in the side wall of the vial. It becomes possible to push over the protrusion. By rounding the bead, a slightly expanding flared portion is provided at the bottom entrance to the vial body, which facilitates insertion and facilitates mechanization of insertion.

The piston 8 further has a integrally molded lower extension 20 in which a central recess 23 is formed to increase its flexibility with respect to the head 10 of the substantially solid piston. I do. The piston is dimensioned to form a hermetic seal with the inner surface of the wall 4 while the land 14 is sufficiently compressed when inserted into the vial 2 to allow the piston to move in the longitudinal direction of the vial. Initially, the piston is located at the bottom of the vial (see FIG. 2) and does not affect the erecting of the base on which the bead 6 is formed, since the bottom of the extension 20 is located exactly in the vial. The relatively heavy solid rubber piston 8 located at the base of the vial stabilizes the empty vial 2 even if its height is somewhat larger than is normally required for stability against diameter. Can be measured. The actual height to diameter limit is set to the value required to convey in a sufficiently stable manner through conventional vial filling and capping machines and to ensure reliable operation of the machine at the preferred speed. In the illustrated embodiment, the vial has an outer diameter of approximately 3 cm and a height of 12.8 cm. For this diameter, 14 centimeters is considered a practical limit for stability, but this ratio will vary to some extent with vial relative wall thickness and piston weight. If the outward projection of the bead 6 is insufficient to affect the stability and therefore the vials can be pressed without tilting each other, the maximum ratio is greater than 4 when using the piston outlined above. It is large and smaller than 5.

The stopper 22 and cap 24, which can be mounted by a conventional vial filling and capping machine, can be of conventional construction, but the stopper 22 will push the vial neck when pushed over the vial (see FIG. 3). Preferably, the structure is substantially filled to minimize dead space above the piston. This allows as much as possible of the contents of the syringe formed by the vial to be extruded by movement of the piston.

The cap 24 is preferably modified as shown in FIGS. In FIG. 3, a conventional main cap cooperates with a molded plastic adapter assembly which includes an annular flange 26 in the cap.
And a cylindrical extension 28 extending through the cap and a thin diaphragm 30 closing the bottom end of the extension. For example, a female screw 32 is formed in the adapter similar to that provided on a conventional syringe adapter for receiving a needle sold under the trademark "LUER-LOK". During storage, the open end of the adapter may be closed with a removable push-on cap and removed prior to use. In FIG. 4, a cylindrical extension 28 is integrally formed with the aluminum cap, which also has a female female 32. With only minor modifications, this extension 28 has been found to be acceptable to normal vial capping machines without interfering with the capping process, while
Such an extension saves a separate adapter cap and the additional assembly steps required to provide it.

To convert a vial into a syringe, use a double ended ne needle of the blood collecting type.
The edle 34 is used directly on the extension 28 (see FIG. 4), or using a needle adapter 36 (see FIGS. 1 and 3) or other dispensing device equipped with a standard syringe coupling. This gives the ejection device the ability to penetrate the diaphragm 30 and the diaphragm 30 if provided. The adapter 36 has a needle 38 and an external thread 40 provided at one end.
Engages a screw 32, while at the other end is provided a female threaded socket 42 and a coaxial plug 44 forming a fluid tight coupling to a needle or the like.

Prior to mounting the double-ended needle 34 or needle and adapter 36, the plunger 46 is attached to the piston extension 20.
In the embodiment shown, the plunger has a cross-shaped shaft 48 and a female threaded sleeve disposed at one end thereof.
50 and an end flange 52 disposed on the other end side. The sleeve 50 is provided with a male multi-thread screw (multis
It has a female multi-thread screw 54 that meshes with tart threads 56. The land between the screw 54 of the sleeve 50 and the screw 56 of the extension 20 stops the outer end of the sleeve 50 and the inner end of the extension 20 shortly, so that the sleeve 50 is positioned under the piston head 10. An abutment is formed to prevent tight screwing. This may cause the force to tilt the plunger to act on the relatively flexible extension 20 and not directly on the head 10, thus breaking the hermetic seal between the head 10 and the vial. Is minimized.

The plunger is a hinge-forming synthetic plastic such as pharmaceutical grade polypropylene.
plastic), the semicircular periphery of the flange
The slots 64 are separated from the remainder by the slots 62 connected only at the connection 66 forming a small hinge. This circumference
Numeral 62 forms a finger loop that can be pulled backward as shown by the dashed line in FIG. 1 to facilitate handling of the plunger. As an additional or other feature, the plunger shaft 48 may be provided with a notch 71 forming a hook, which may be used to suspend the syringe when used in certain injection applications.

Fill the vial 2 with a cap to prevent the piston from being withdrawn as a whole, form a guide for the plunger, regulate its tilt, and provide various functions to form a finger grip for the user. After closing, the integrated finger grip and retainer 16 is pushed into the bottom of the vial 2. It comprises a sleeve 18 and a peripheral flange forming an opposing finger tag 68.
Further, it is molded from a pharmaceutical grade plastic such as polypropylene. The sleeve 18 is resiliently press fit into the open end of the vial 4 and is slightly compressed by the inward protrusion of the bead 6 upon insertion. Insertion of the retainer 16 is facilitated by at least moderate heating of the retainer, and the slight bulging of the bead 6 facilitates this insertion. Finger tag 68
At a position close to the sleeve 18, the tubular member sleeve 18 has a shallow arc-shaped groove, and when the sleeve is pushed back to its original state,
A portion 70 of the bead 6 which forms a holding means projecting in the radial direction fits into the groove. The force acting on the finger tag 68 pulls the sleeve 18 away from the vial,
Deform this sleeve and in this manner the beaded part
Increases the grip force of the groove by 70 and opposes the pull-out force of the sleeve.

For production, an empty vial 4 is transported through a conventional sterilization station, a piston 8 is inserted into the vial 4, and the vial is filled and closed with a cap using conventional vial filling and capping machines. It is preferable to use a modified cap as shown in FIGS. 1 and 3 or FIG. 5). Then, the guide and the sleeve 18 are fitted into the base of the vial, and are shipped without the plunger 46 attached.
Prior to use, the plunger 46 is screwed into the piston, a needle or the like is attached to the extension 28 and, if necessary, the stopper 22.
Adapter 36 is used to penetrate the syringe, which allows the syringe to be used.

FIG. 5 shows a modified example of the bottom end of the vial body,
In this variation, another attempt is made to place a bead at the bottom end approximately within the diameter of a cylindrical vial body.
This type of peripheral bead, which surrounds the opening in the glass body, provides flame softening to the glass,
The body is formed by adjusting the position and shape while rolling the body on a suitable forming surface. In the embodiment of FIG. 5, the bottom 74 of the body 4 is softened by a flame and rolled,
In the present embodiment, the diameter is slightly reduced over a length of about 5 to 6 mm. By expanding the bottom of the reduced diameter portion, a normal outwardly rounded bead 6 is formed. This diameter reduction is such that at least the majority of the bead is within the diameter of the main part of the body and does not require excessive force when inserting the piston. In the embodiment shown, the outside diameter of the bead is slightly larger than the outside diameter of the main part of the body, but this is not necessary. In an exemplary embodiment, the inner and outer diameters of the vial body are 27 mm and 30 mm, respectively, with a wall thickness of 1.5 mm and a reduced diameter at the bottom of about 1 mm. And a bead can be formed by expanding the bottom of the body, in this case,
It is typically only 0.5 mm without increasing the outside diameter of the bead much beyond the outside diameter of the vial body. A special flare 76 can also be provided, in which case the piston is easy to insert despite the reduced diameter of the bottom of the body, and the flare allows the vial to stand upright on a flat surface. Bottom contact line 78 is vial main body 4
Approximately concentric with the outer diameter of the vehicle, thus maximizing stability. Even if the vial bodies are adjacent when pressing on the line, the tendency to tilt as would occur with this type of flared bottom structure is prevented.

By inserting the piston into the vial body,
Significant mass will be added and the vial stability will be measured, while the mass of the piston relative to the mass of the vial body will decrease as the vial height decreases. However, as the vial height increases, the position of the center of gravity of the assembly rises less than without the piston. Further, it is desirable that the vial body be stable without the piston and be transported through the sterilizer prior to insertion of the piston. In such a situation, the present invention is particularly advantageous in this regard, since the bead projecting beyond the diameter of the main body of the body at the open end has a very detrimental effect.

To cooperate with this modified vial body shape, the finger grips / retainers 16 also need to be modified.
A bead 80 is provided at the upper end of the sleeve 18 instead of the groove,
This bead may be molded with slots 82 to facilitate insertion if necessary, and / or member 16 may be warmed to facilitate insertion. The bead must hold the member with sufficient strength and withstand the pressure from the piston, which is formed through the pressure created in the vial during normal storage, Pressing the member against the shoulder 84 by the piston contacting the bead can help to actually hold the member. When the portion 18 of the member 16 is dimensioned to abut the lower surface of the piston, it assists in stabilizing the piston and maintaining a hermetic seal.

──────────────────────────────────────────────────続 き Continuation of the front page (56) References JP-A-58-58285 (JP, A) JP-A-60-234670 (JP, A) Fully open Showa 59-100433 (JP, U) 53749 (JP, U) Japanese Utility Model Application Hei 2-55958 (JP, U) US Patent 3,967,759 (US, A) (58) Fields investigated (Int. Cl. ⁷ , DB name) A61M 5/24 A61M 5/28

Claims (8)

(57) [Claims] 1. A cylindrical glass having a vial having an open neck at one end and a peripheral outer flange surrounding an outer end of the neck, and a peripheral edge (6) defining an inner circumference at an open opposite end. And a piston (8) made of an elastic material having a cylindrical head (10) concentrically disposed in the vial body, the piston being slidably and airtightly sealed with the inner surface of the body. And the piston (8) is positioned entirely within the body to form a syringe plunger (46) between the piston head and the neck of the vial, forming a chamber of a volume equal to the nominal volume of the vial. ) Having an integral coupling structure (20) for retrofitting, said vial tipping through the vial filling and capping machine when standing upright (6) The body is maintained in a stable state so that it can be transported in an upright state, and the body is formed with holding means (70, 84) protruding in the radial direction along the periphery in the vicinity of the opening end. Filled by transport through a vial filling and capping machine, which engages the corresponding features of the tubular piston retaining member (16) which is subsequently inserted into the open end of the vial filling and capping machine A drug vial, which is later used to form a syringe barrel and a piston, wherein said holding means (7
0,84) and the peripheral edge (6) are integral with the lower end of the body, and the body has at least a part of its inner side formed with a protruding peripheral part of the main inner cylindrical surface. (70,8
4) and the peripheral edge (6) are located substantially within the protruding perimeter of the main cylindrical outer surface of said body (4), said body being free of protrusions without adversely affecting the stability of the vial (2). The vial is further formed with a side surface, the vial further comprising a medicament in the chamber, a stopper inserted into the neck and through which a needle can be penetrated, and a stopper fitted to the stopper and the flange of the neck to hermetically seal the stopper to the neck. An annular cap for maintaining the fitted state, and a finger grip and piston holding member (16), wherein the finger grip and piston holding member (16) is press-fitted into the open end of the vial body ( 18) and a flange (68) located at the outer end of the tubular member and forming an outwardly extending finger tab, the tubular member comprising a flange near the finger tab. It provided with recesses on its outer surface adjacent, vials, characterized in that to accommodate the inner holding means of the inner wall of the body (70,84). 2. Retaining means (70) over said projecting perimeter.
2. The outer projection of the peripheral edge (6) does not exceed 20% of their overall radial dimension.
The vial described. 3. The vial according to claim 2, wherein the vial has a height approximately four times its diameter. 4. A cylindrical bottom part (74) of the body below the piston is reduced in outer diameter, and the peripheral part (6) is formed in a flare part (76) at an open end of the body. The vial according to 1. 5. A cylindrical bottom (74) of said body (4),
A shoulder (84) is formed along the circumferential direction between the main inner cylindrical surface and the bottom inner cylindrical surface having a reduced inner diameter and an outer diameter, and the outer cylindrical shape of the bottom is formed. The surface has an outwardly projecting peripheral edge (6), which is substantially arranged in a peripheral projection of the main cylindrical outer surface of the body (4), and which has a shoulder and a peripheral projection. 2. The vial according to claim 1, wherein at least one of said vias forms said retaining means, and a piston can be inserted through the reduced inner diameter of the bottom. 6. The cap (24) is provided with a concentric and tubular outer extension (28) for receiving one of a hollow double-ended needle and an adapter for accommodating a hollow single-ended needle. The vial according to any one of claims 1 to 4, wherein a hollow needle provided at one end or an adapter can penetrate the stopper. 7. A syringe kit comprising a first subassembly and a plunger, wherein (i) the first subassembly comprises: (a) a drug vial used to form a syringe barrel and piston. A vial having an integral neck at one end, a peripheral outer flange surrounding the outer end of the neck, and a peripheral edge (6) forming an inner periphery at the open opposite end. And (b) an elastic piston (8) having a cylindrical head (10) concentrically disposed in the glass vial body. The piston is slidably maintained in a hermetically sealed relationship with the main inner cylindrical surface of the vial body and is located in a position that forms a volume between the piston head and the neck of the vial equal to the nominal volume of the vial. The piston (8) has an integral coupling structure (20) disposed entirely within the vial body, and (c) on the piston (8) via the vial open neck. And (d) a stopper which is inserted into the neck and through which a needle can penetrate, and an annular cap is fitted to the stopper and a flange of the neck, and the stopper is airtightly connected to the neck. And (ii) the plunger is engaged with the coupling means of the piston (8) so that the piston (8) can project toward the neck, and the vial has a peripheral edge ( 6) When standing upside down, maintain a stable state so that it can be transported in the upright state without falling over through the vial filling and capping machine, and the body is located near the open end in a radial direction. The holding means (70, 84) is formed along the peripheral part, and the holding means (70, 84) and the peripheral part (6) are integral with the lower end of the body. A part of the body (4) is formed with a protruding peripheral portion of the main inner cylindrical surface, and the holding means (70, 84) and the peripheral portion (6) are substantially protruded from the main cylindrical outer surface of the body (4). A syringe kit, wherein the body is formed with a projection-free outer surface that is disposed in a peripheral portion that does not adversely affect the stability of the vial (2). 8. A tubular piston holding member inserted into the open end of the vial body and resisting overpressure in the vial body, the tubular piston holding member engaging with the holding means (70, 84). The syringe kit according to claim 7,