EP1237597A1

EP1237597A1 - Pre-filled syringe and method for making same

Info

Publication number: EP1237597A1
Application number: EP00988900A
Authority: EP
Inventors: Antoine Aneas
Original assignee: Biodome SAS
Current assignee: Biodome SAS
Priority date: 1999-12-14
Filing date: 2000-12-07
Publication date: 2002-09-11
Also published as: FR2802104A1; ZA200204374B; FR2802104B1; KR20020062965A; CA2394362A1; MXPA02005946A; CR6675A; WO2001043799A1; US20030060749A1; JP2003516821A; BR0016376A; AU2524901A; NZ519405A

Abstract

The invention concerns a syringe comprising a syringe body (2) including an elongate barrel (4) containing a volume of medical fluid (44), one first end forming a hub (16), designed to co-operate with a needle of said syringe, a second end (6) opposite the hub and a plunger (28) mobile relative to said hub. The second end forms a closed base (6) and the plunger (28) is entirely housed inside the barrel (4). Said syringe body is inexpensive, easy to produce, provides satisfactory fluid-tightness and prevents all microbial migration towards the medical fluid.

Description

PRE-FILLED SYRINGE AND MANUFACTURING METHOD THEREOF

The present invention relates to a pre-filled syringe body, a pre-filled syringe provided with such a body, a set of these bodies and a method of manufacturing such a body. Usually, a pre-filled syringe body contains a volume of medical liquid, which is for example an injectable preparation, or even a charge of such a preparation. This body comprises an elongated envelope, as well as a first end, forming a nozzle, and a second end opposite to the aforementioned nozzle. The body also receives, in a sliding manner, a piston movable relative to one end piece.

In known manner, this body can be produced by injecting plastic material, while leaving an opening in its second end. Then, the medical liquid is poured out through the aforementioned opening and the piston is brought back in the vicinity of the liquid thus transferred. During these operations, as well as during the possible storage of the syringe body, the tip is provided with a sealing cap.

Immediately before use, the sealing cap is removed from the end piece and a fitting fitted with a needle is fitted to the latter. Finally, the piston is made to slide in the envelope, by pressing on the actuating end, so as to inject the medical liquid.

This known syringe body has certain drawbacks, in particular in terms of safety of use. In fact, the medical liquid is liable to flow through the opening made in the bottom of the body, in particular if the piston rod is pulled too far back.

In addition, this syringe body does not make it possible to satisfactorily avoid any microbial migration towards the medical liquid which it contains. Indeed, microbes are likely to reach this liquid through the opening of the second end of the body, both during the manufacturing and storage phases, and during the actual use of the syringe body. This migration can also be initiated from the actuation end of the body, located outside the envelope and which can therefore be contaminated.

Finally, this syringe body involves relatively long and complex production phases, and has a high cost.

In order to overcome these various drawbacks, the invention proposes to produce a pre-filled syringe body, the manufacturing process of which is simple and inexpensive, which guarantees reliable preservation of the medical liquid it contains, even in the case long-term storage, which largely avoids any risk of microbial contamination during the storage and use phases.

For this purpose, it relates to a pre-filled syringe body containing a volume of medical liquid, said body comprising an elongated envelope, a first end forming a tip, intended to cooperate with a needle of said syringe, a second end opposite to said tip and a piston movable relative to said nozzle, characterized in that said second end forms a closed bottom, integrally formed with the envelope, and said piston is housed entirely inside said body.

The syringe body according to the invention provides a satisfactory seal, since it has a closed bottom. This therefore makes it possible to avoid leaks of liquid flowing through the opening provided in the prior art, in the case of improper handling. This closed bottom also preserves any microbial contamination.

Furthermore, this background came integrally with the envelope. This is advantageous in terms of simplicity of manufacture and sealing. Finally, since the piston is housed entirely inside the envelope, the actuating end of the piston cannot come into contact with a non-sterile body or organ, which avoids any microbial contamination, by through this actuating end.

According to an advantageous characteristic of the invention, the envelope comprises an actuating portion, deformable in the direction of movement of the piston, which is terminated by a region for driving an end of actuation of the piston.

This allows easy movement of the piston during the injection phase of the medical liquid.

According to other characteristics of the invention: - the drive region comprises the bottom of said body, said bottom being secured to the actuating end, in particular by welding;

- Said deformable portion is a bellows. According to an advantageous characteristic of the invention, said deformable portion is extended, opposite the bottom, by a portion for receiving the volume of medical liquid and said deformable portion is provided with a finger support zone d 'a user, adjacent to said receiving portion. This support zone allows a user to bring two of his fingers into abutment, for example the index and middle fingers, then to easily exert pressure with his thumb on the closed bottom of the body, this which then drives the actuating end of the piston. According to another advantageous characteristic of the invention, the end piece is provided with a removable sealing member, made integrally with said envelope.

This member makes it possible to impart satisfactory sealing to the nozzle, during storage of the syringe body. Furthermore, since it came as a single piece, this member cannot be adapted again on the end piece, after having been removed therefrom, which makes it possible to avoid any problem of microbial contamination. This is to be compared with the prior art, making use of sealing caps capable of being repositioned after having been removed from their tip.

According to another characteristic of the invention, the sealing member is breakable, by thinning of material.

According to another characteristic of the invention, the organ sealing is integral with gripping means, in particular a tongue. This ensures particularly simple use and easy detachment of the cap.

According to another advantageous characteristic of the invention, the end of said piston in contact with the liquid, opposite the end of actuation, is arranged, in a transversely compressed state, in a jacket integral with the envelope, a lubricant being interposed between the walls opposite this contact end and the jacket. This guarantees easy sliding, in service, of the contact end with respect to the interior walls of the envelope. In addition, since this end is compressed in the jacket, it is able to deform radially outward, so as to cooperate intimately with the walls of the envelope, in order to ensure a satisfactory seal.

According to another characteristic of the invention, the internal transverse dimensions of the jacket are smaller than those of the envelope. The invention also relates to a pre-filled syringe, comprising a body and a needle integral with said body, characterized in that this body is as defined above.

The invention also relates to a set of several pre-filled syringe bodies as defined above, these bodies being linked in pairs in a removable manner.

This is advantageous in terms of storage and also allows simple use. In this way, it is possible to manufacture a ply of syringe body, from which each body is detached immediately before its use.

According to another characteristic of the invention, two neighboring bodies are connected by welding the ends opposite their deformable portions and / or their gripping tabs. The invention finally relates to a method of manufacturing a pre-filled syringe body, containing a volume of medical liquid, said body comprising an elongated envelope, a first end forming a tip, intended for cooperate with a needle of said syringe, a second end opposite to said tip and a piston movable relative to said tip, characterized in that it comprises the following steps: - a blank is made of said body, leaving said first end closed;

- Said liquid is poured into the interior volume of one blank;

- the piston is brought in the vicinity of the liquid; - The second end is produced, in the form of a closed bottom.

The manufacturing process of the invention guarantees substantial simplification, as well as a significant reduction in costs, compared to the prior art. Indeed, in accordance with the invention, the liquid is poured out and the piston is brought back before making the bottom of the body, which allows a particularly rapid manufacture. This is to be compared with the prior art, in which, once the body has been made, the liquid must be transferred and then the constituent elements of the piston must be attached, by means of the orifice made in the bottom.

According to an advantageous characteristic of the invention, the closed bottom is produced while producing a deformable portion of said envelope. This is advantageous in terms of speed and simplicity of manufacture.

According to other characteristics of the invention:

- Said deformable portion is produced by adding, perpendicular to the main axis of the envelope, at least two mold elements provided with notched molding walls;

- Said piston is brought back after having surrounded it, in a transversely compressed state, by means of a jacket, the outer walls of said jacket are brought in the vicinity of the interior walls facing the envelope, and the jacket is secured with the envelope;

- the outer walls of the jacket are brought in the vicinity of the inner walls of the envelope in a state transversely expanded these interior walls, and these interior walls are constricted, in particular by cooling, so as to secure the jacket and the envelope;

- The body is produced by blowing its constituent plastic material.

The invention will be described below, with reference to the accompanying drawings, given only by way of nonlimiting examples and in which:

- Figure 1 is a perspective view, with parts broken away, of a syringe body according to the invention;

- Figure 2 is a longitudinal sectional view, on a larger scale, illustrating the relative positioning of the envelope and the thrust end of the piston belonging to the syringe body of Figure 1, - - Figures 3 to 5 are sectional views illustrating three successive phases of the manufacture of the syringe body of Figure 1;

- Figure 6 is a side view illustrating a set of several syringe bodies, each of which is identical to that of Figure 1;

- Figure 7 is a side view, illustrating the use of the syringe body of Figure 1;

FIG. 8 is a view similar to FIG. 7, illustrating a syringe according to the invention, in its final phase of use and

- Figures 9 and 10 are sectional views, on a larger scale, illustrating the tip of a syringe body according to a variant of the invention, in two successive phases of its use. The syringe body 2 shown in Figure 1, which is made of a plastic material, such as polyethylene, comprises an elongated hollow casing 4, terminated by a closed bottom 6 of the body, integrally formed with this casing. The latter is provided with a bellows 8, which constitutes a deformable portion of this envelope 4, and defines several notches, or undulations 10.

The casing 4 also comprises a cylindrical portion 12, the diameter of which corresponds substantially to that of the inner part of the notches 10. This cylindrical portion 12 is terminated, opposite the bottom 6, by a re-entrant radial shoulder 14, from which extends a tubular endpiece 16, co-axial to the envelope 4. This endpiece is integral with a sealing member 18 with a closed bottom. The latter, which came integrally with the endpiece 16, is generally spherical. The connection between this endpiece 16 and the member 18 is produced by an annular breakable zone 20, formed by thinning of material. The cap 18 is integral with a gripping tongue 22, which is connected to the shoulder 14 by means of studs 24. The connection between the shoulder 14 and the studs 24 is constituted by two breakable zones 26 formed by thinning matter. The syringe body 2 also comprises a plunger, made of plastic material, which is designated as a whole by the reference 28. This plunger has an actuating end 30, which is of shape complementary to that of the interior walls of the adjacent notch 10A at the bottom 6. This actuating end 30 is secured to the inner wall of the bottom 6 by welding, as will be explained in the following. The piston 28 also includes an end 32, or core, intended to be in contact with a medical liquid. This core 32 is connected to the actuating end 30 by a rod 34, co-axial with the casing 4 and extending along the bellows 8.

As shown more precisely in Figure 2, the outer periphery of the core 32 is surrounded by a jacket 36, integral with the casing 4 as will be explained in the following. This jacket 36 extends axially, in the direction of the end piece, beyond the core 32. It is also provided, opposite this end piece, with a re-entrant collar

38, partially covering the opposite end of the core 32.

The periphery of this core is wavy, so that it forms, with the adjacent walls of the jacket 36, notches filled with a lubricant 40, such as silicone. This jacket 36 extends in an annular recess 42 which is provided with the inner wall of the portion cylindrical 12. At its edge oriented towards the endpiece 16, this jacket has an inner diameter d smaller than that D of the casing 4, but an outer diameter d 'larger than the inner diameter of this casing. The endpiece 16 defines, with the opposite face of the core 32, a useful internal volume V which is filled with a medical liquid 44, for example an injectable preparation or even a charge for such a preparation.

The method of manufacturing the syringe body 2 will be explained with reference to FIGS. 3 to 5.

For this production, use is made of a mold 46 comprising a fixed lower part 48 defining a molding cavity 50 allowing the formation of the cylindrical portion 12, the end piece 16, the cap 18 and the tongue 22 This mold 46 also comprises a movable part 52, formed of two mold elements 54 capable of moving relative to one another, in a direction perpendicular to the main direction of the envelope 4. These movable elements 54 have interior walls 56 of molding provided with notches 58, corresponding to the notches 10 of the body 2 once produced.

In a first manufacturing phase, the movable elements 54 are separated from one another, then a plastic parison 60 is introduced into the cavity 50, which is deformed by blowing in a sterile atmosphere, after the have previously softened, for example by the action of heat.

Is molded in the cavity 50, the cylindrical portion 12, the tip 16, the cap 18 and the tongue 22. Outside the mold, it also surrounds the core 32 by means of its jacket 36, inserting the lubricant 40 between the facing walls of this core 32 and of this jacket 36.

Then, still operating in a sterile environment, the medical liquid 44 is poured into the cylindrical portion 12, via a conduit 61. The edges 62 of the parison, opposite the cavity 50, surround, at their upper end not shown, this conduit 61 for supplying the liquid 44. Then, the conduit 61 is removed and the upper end of the edges 62 is removed, so as to produce an end open 64, by which the piston 28 is provided, provided with its jacket not shown, above the liquid 44 transferred.

Since the parison 60 is softened under the effect of heat, it is subjected to a slight radial expansion, so that the outer walls of the jacket are free from contact with the inner walls of the parison 60, intended to form the cylindrical portion 12.

Once the piston has been added, the mobile elements 54 are brought closer to one another (FIGS. 4 and 5), so that their ends opposite the fixed part 48 form a joint plane 66. This approximation allows the formation of the bottom 6 of the body, as well as the bellows 8 of the casing 4, the lateral edges 60 ′ of the parison 60 being joined by a weld line. The notches 58 of the molding walls of the elements 54 also induce the production of the notches 10 of the bellows 8.

Then, the plastic material constituting the casing 4 is allowed to cool, which causes a slight reduction in the transverse dimensions of this casing, and in particular of the cylindrical portion 12. In this way, the jacket 36, whose transverse dimensions do not not vary, is made integral with the area opposite the cylindrical portion 12, which is constricted. Furthermore, there is a phenomenon of welding between the walls opposite the bottom 6 and the actuating end 30 of the piston 28.

Figures 3 to 5 describe the formation of a single body 2. However, it is possible to make several such bodies, one beside the other, by means of a single blowing operation and a single mold. This then leads to the obtaining of a clearance 68 formed by several syringe bodies 2, the adjacent regions of which are linked to each other by welding. More precisely, the adjacent walls of the tongues 22 are joined by a weld line 70, while the adjacent zones of the bellows 8 are joined by several weld points 72 arranged along the welds joining the lateral edges 60 ′ of the parison 60.

The operation of the syringe body 2 will now be explained, with reference to FIGS. 7 and 8. First, a body 2 is detached from the clearance 68, shown in FIG. 6, by action on the line 70 and the welding points 72. Then, the tongue 22 is detached, for example by rotating it around the main axis of the casing 4. A fitting 74 of known type, provided with an injection needle 76, is then adapted on the endpiece 16, the end of which has been opened, so as to form a syringe 78 (FIG. 8 ). The operator then places two of his fingers, for example the index and middle finger, on the notch 10B of the bellows, adjacent to the cylindrical portion 12. Once his two fingers bear on the notch 10B, the operator exercises, with his thumb, pressure on the bottom 6, which contributes to folding the bellows by bringing together its notches 10.

This action induces the displacement of the core 32, relative to the jacket, not shown in Figures 7 and 8, in the direction of the tip. This movement is facilitated by the presence of the lubricant 40. The medical liquid 44 is thus injected into a patient, via the needle 76. At the end of the operation, the bellows 8 is fully folded and the pushing core 32 of the piston 28 bears against the internal wall of the shoulder 14, as illustrated in FIG. 8.

It is also conceivable to pour the medical liquid 44 into an annex bottle, containing an adjuvant, such as a powder or a lyophilisate. This operation can be carried out by means of a connection device, such as that described in O-A-97/10156. Then mixed in the bottle, the medical liquid and its adjuvant and transferred into the envelope 4 the mixture thus formed, having previously returned the bellows to its unfolded position illustrated in Figure 7. This mixture can then be injected into the patient according to the procedure described above.

Figures 9 and 10 show an alternative embodiment of the invention, in which the casing 104 is extended by a cap 118, forming a sealing member, which has come in one piece and connected to the casing via 'an annular breakable zone 120. This cap 118 is also secured to a gripping tongue 122. A tip 116 is attached in the vicinity of the end of the envelope adjacent to the cap 118, one end of this tip being in abutment against the wall opposite the cap 118. This tip 116, which is hollowed out of a channel opening 117, co-axial with the envelope, is provided with a male end 117 ′ of the "LUER LOCK" type, allowing the adaptation, in known manner, of a female end not shown of the "LUER LOCK" type. The use of this syringe body 102 consists, analogously to what has been described above, in rotating the tongue 122, so as to detach it from the envelope 104, the channel 117 then putting the interior volume of the envelope 104 with the exterior. Then adapting the above-mentioned threaded connection to the thread 117 ′ and injecting the medical liquid.

Claims

1. Body (2; 102) of pre-filled syringe (78), containing a volume of medical liquid (44), said body comprising an elongated envelope (4; 104), a first end forming a tip (16; 116), intended to cooperate with a needle (76) of said syringe (78), a second end (6) opposite to said tip and a piston (28) movable relative to said tip, characterized in that said second end forms a bottom (6) closed, integral with the envelope (4; 104), and said piston (28) is housed entirely inside said body (2; 102).

2. syringe body according to claim 1, characterized in that said envelope (4; 104) comprises a portion (8) of actuation, deformable in the direction of movement of the piston (28), which is terminated by a region d drive (6) of an actuating end (30) of the piston.

3. syringe body according to claim 2, characterized in that the drive region comprises the bottom (6) of said body (2; 102), said bottom being integral with the actuating end (30), in particular by welding.

4. syringe body according to one of claims 2 or 3, characterized in that said deformable portion is a bellows (8).

5. syringe body according to one of claims 2 to 4, characterized in that said deformable portion (8) is extended, opposite the bottom (6), by a receiving portion (12) of the volume of liquid medical (44) and in that said deformable portion (8) is provided with a support zone (10B) of the fingers of a user, adjacent to said receiving portion (2).

6. syringe body according to one of claims 1 to 5, characterized in that said tip (16; 116) is provided with a removable sealing member (18; 118), integrally formed with said envelope.

7. syringe body according to claim 6, characterized in that said sealing member (18; 118) is breakable, by thinning of material (20; 120).

8. syringe body according to one of claims 6 or 7, characterized in that said sealing member (18; 118) is secured to gripping means, in particular a tongue (22; 122).

9. syringe body according to one of claims 1 to 8, characterized in that the end (32) of said piston (28) in contact with the liquid, opposite the actuation end (30), is arranged, in a transversely compressed state, in a jacket (36) integral with the casing (4; 104), a lubricant (40) being interposed between the walls opposite this contact end (32) and the jacket (36).

10. syringe body according to claim 9, characterized in that the internal transverse dimensions (d) of the jacket (36) are smaller than those (D) of the envelope (4; 104).

11. Pre-filled syringe (78) comprising a body (2) and a needle (76) integral with said body, characterized in that said body (2) conforms to any one of the preceding claims.

12. Set (68) of several bodies (2) of a pre-filled syringe according to any one of claims 1 to 10, said bodies (2) being linked in pairs detachably.

13. Game according to claim 12, in combination with one of claims 8 to 10, characterized in that two neighboring bodies are connected by welding the ends opposite their deformable portions (8) and / or their gripping tabs (22).

14. A method of manufacturing a body (2; 102) of a pre-filled syringe, containing a volume of medical liquid (44), said body comprising an elongated casing (4; 104), a first end forming a tip (16; 116), intended to cooperate with a needle of said syringe, a second end (6) opposite to said tip and a piston (28) movable relative to said tip, characterized in that it comprises the following steps: - A blank (60) of said body is produced, leaving said first closed end (18);

- Said liquid (44) is poured into the interior volume of the blank (60); - the piston (28) is brought in the vicinity of the liquid

(44);

- Said second end is produced, in the form of a closed bottom (6).

15. The manufacturing method according to claim 14, characterized in that said closed bottom (6) is produced while producing a deformable portion (8) of said envelope (4).

16. The manufacturing method according to claim 15, characterized in that said deformable portion (8) is produced by bringing, perpendicular to the main axis of the envelope (4), at least two mold elements (54) provided notched molding walls (56).

17. Manufacturing method according to one of claims 14 to 16, characterized in that said piston (28) is returned after having surrounded it, in a transversely compressed state, by means of a jacket (36), brings the outer walls of said jacket (36) in the vicinity of the inner walls facing the envelope (4), and the jacket (36) is secured to the envelope (4).

18. The manufacturing method according to claim 17, characterized in that the outer walls of the jacket (36) are brought in the vicinity of the inner walls of the envelope (4) in a transversely expanded state of these inner walls, and in what is shrunk these interior walls, in particular by cooling, so as to secure the jacket (36) and the envelope (4).

19. Method according to any one of claims 14 to 18, characterized in that the body (2; 102) is produced by blowing its constituent plastic material.