EP0792135B1 - Syringe device attachable to a bottle - Google Patents

Description

The present invention relates to a syringe device fixable on a bottle, in particular a bottle containing a liquid inject or a freeze-dried product to be mixed with a liquid physiological or medication to inject the mixture.

We know that there are, especially in the medical field, products which must be stored separately and which must not be mixed at the time of their injection into a patient, for example by subcutaneous, intravenous or muscular route. It is in particular the cases of drug products that are prepared in the form lyophilized, or in powder form, and which must be mixed with a solvent, for example physiological saline, to allow administration to the patient. In other cases, the two compounds mixed can be liquids, these liquids cannot be kept for a long time in mixed form.

The most commonly used solution is to store the powder in a separate container which is sealed with a membrane or waterproof cap that can be pierced with a needle. In addition, with a standard type syringe, we just draw in a second container a certain amount of solvent and injected into the first container to through the membrane the desired amount of solvent. We then mix the whole in the first container and, using the same syringe, we sucks the mixture. The syringe is then ready for injection of the drug.

In other known solutions, the liquid, for example the serum physiological, is already contained in the syringe. It then suffices to inject through the perforable membrane the liquid in the container containing the product in powder form and then re-aspirate the whole after its mixed.

However, this solution presents certain employment difficulties. In particular, when the bottle containing the powder has a neck of reduced diameter, it is difficult to puncture the cap properly perforable. Indeed, the fact of perforating the perforable stopper in its center and minimize the introduction of the needle into the bottle is a prerequisite for obtaining the sample from the all of the liquid in the bottle after mixing the powder with solvent. In addition, it prevents wetting the needle during this operation, which allows the reuse of the needle for injecting the mixture into the patient. In the case, as already indicated, where the diameter of the neck of the bottle is small, this can be tricky. Alternatively there is a risk significant that the user, for example the nurse, is pricking a finger during this operation.

US-A-5,247,972 describes a syringe device according to the preamble of claim 1.

An object of the present invention is to provide a device for syringe fixed on a bottle which ensures the perforation of the stopper perforable in its center and which, moreover, makes this operation very safe and perfectly repetitive. Furthermore, an object of the present invention is to provide such a device that is adaptable to the bottle commonly used to contain medicated powders mix with a solvent and in particular lyophilized products.

To achieve this object, according to the invention, the syringe device fixable on a bottle having a cylindrical body, an opening surrounded by a flange having a side face and a plug perforable closing off said opening comprising a guide piece able to cooperate with said bottle and a syringe provided with a needle and of a body and sliding mount in said guide piece, said guide piece having a first open end having at its terminal part a first internal surface cylindrical guide capable of cooperating with the cylindrical body of said a sufficient length of bottle, a second internal surface of guide able to cooperate with the side wall of the flange of the bottle, and means for securing said piece to said collar separate from said guide surfaces and set back relative to said first internal guide surface, said securing means being activated during the establishment of said device on said bottle, said guide piece comprising a second end and a running part capable of receiving said syringe provided with means for guiding said translation in translation syringe in said guide piece for bringing said syringe in a depressed position in which the needle pierces the perforable membrane of the bottle, characterized in that the piece of guidance is in one piece and it has a means defining a central orifice of reduced diameter inside which the end of the needle is arranged and which allows the passage of the end of said needle under the effect of displacement in translation of said syringe.

We understand that thus, thanks to the presence at the end of the guide part of the guide surfaces which cooperate with the bottle over a sufficient length, it ensures perfect centering of the part guide relative to the perforable cap of the bottle. In As a result, the tip of the syringe needle is perfectly positioned opposite the central part of the perforable plug of the bottle, which ensures a puncture of the cap under conditions when pushing the syringe into the room guidance. In addition, the syringe being guided in translation relative to the guide piece, thus ensuring the maintenance of the positioning of the needle relative to the stopper when moving the syringe. In addition, the presence of the fastening elements makes it possible to secure the guide piece and therefore the syringe on the vial, which makes it easier to handle the syringe compared to the bottle. In particular, this allows very precise control the insertion of the syringe into the guide piece and therefore the penetration of the tip of the needle into the bottle after perforation of the plug, so that penetration is reduced as much as possible. Well heard, after the mixing operation and the reintroduction of the mixture in the syringe, it can be separated from the guide piece.

Preferably, the securing means are arranged between the first and second guide surfaces.

Preferably also, according to a first mode of implementation work, the means for guiding the syringe in translation in the guide piece include sealing means for ensuring a seal between the internal face of the guide piece and the body of said syringe.

According to a second mode of implementation, the means of guide the syringe in the guide piece include at at least one guide face formed in the internal face of the workpiece guide able to cooperate with a portion of the body of said syringe.

According to another characteristic of the invention, the guide piece has a plate member disposed substantially perpendicularly to the direction of movement of the syringe in which is formed said central orifice, the face of said plate facing the first end of the guide piece being provided with a rib projecting annular surrounding said central orifice, whereby said rib is applied against the stopper of said bottle when said securing means cooperate with said bottle.

• la figure 1 est une vue en coupe verticale d'un flacon utilisable avec le dispositif de seringue selon l'invention ;
• la figure 2 est une section d'un premier mode de réalisation du dispositif de seringue ;
• la figure 3 est une vue en perspective du dispositif de seringue fixé sur un flacon ;
• la figure 4a est une vue de détail de la figure 2 montrant la fixation du dispositif de seringue sur un flacon ;
• la figure 4b est une vue en coupe horizontale selon la ligne B-B de la figure 4a ;
• la figure 5 est une vue en coupe verticale et en perspective d'un deuxième mode de réalisation du dispositif de seringue fixé sur un flacon ;
• les figures 6a à 6c illustrent l'utilisation du dispositif de seringue ; et
• la figure 7 montre en coupe verticale partielle un troisième mode de réalisation du dispositif de seringue.

Other characteristics and advantages of the present invention will appear better on reading the following description of several embodiments of the invention given by way of nonlimiting examples. The description refers to the appended figures in which:

• Figure 1 is a vertical sectional view of a vial usable with the syringe device according to the invention;
• Figure 2 is a section of a first embodiment of the syringe device;
• Figure 3 is a perspective view of the syringe device attached to a vial;
• Figure 4a is a detail view of Figure 2 showing the attachment of the syringe device on a vial;
• Figure 4b is a horizontal sectional view along line BB of Figure 4a;
• Figure 5 is a vertical sectional perspective view of a second embodiment of the syringe device attached to a vial;
• Figures 6a to 6c illustrate the use of the syringe device; and
• Figure 7 shows in partial vertical section a third embodiment of the syringe device.

Referring first to Figure 1, we will describe a bottle 10 of standard type containing for example a medicament in the form freeze-dried. The bottle 10 comprises a cylindrical body 12 and a neck 14 limiting an opening 16. The neck 14 is surrounded by a collar cylindrical 18 which has a lateral face 20, an upper face 22 and a lower face 24. The bottle is closed by a stopper made of a perforable material 26 which is engaged in the opening 16 of the bottle. The periphery 28 of the plug is applied against the upper face 22 of the flange and a metal crimping cap 30 ensures the watertight fixing of the cap on the opening 16 of the bottle 10.

It is understood, in view of Figure 1, that the diameter D constituting the perforable central part of the cap is relatively small, this diameter depending on the dimensions of the bottle which can range from 5 to 2 mm.

Referring now to Figures 2 to 4, we will describe a first embodiment of a syringe device fixable on a bottle such as that shown in FIG. 1. The device for syringe 40 is essentially constituted by a guide piece 42 and a conventional type syringe 44 fitted with a needle 45. The part of guide 42 which preferably has a symmetry of revolution around the axis XX 'has a first end 46 intended to be secured to the bottle 10, a second end 48 intended for receiving and guiding in translation the syringe 44 and a running part intermediate 50. The first end 46 includes a first guide surface 52 of internal diameter D'2 intended to cooperate with the cylindrical part 12 of the bottle, the latter having a diameter D2 slightly smaller than the diameter D'2. The end 46 has a second guide revolution surface 54 intended to cooperate with the side face 20 of the flange 18 of the bottle, this guide surface having an internal diameter D'1 slightly greater than the diameter D1 of the collar 18. Between the guide surfaces 52 and 54, the end 46 of the guide piece has elastic clip elements 58 used to secure the end 46 of the guide piece 42 on the neck of the bottle 10. As best shown in Figures 2 and 4, the end 46 of the guide piece is connected to its current part by a part forming a plate 60 substantially orthogonal to the axis XX 'and making integral part of the guide piece. This plate 60 is provided with a axial sleeve 62 which defines a central orifice 64 arranged along the axis XX 'of the guide piece. The central opening 64 is extended by a frusto-conical part 66 facing the second end of the part guidance. When the syringe 44 is mounted on the guide piece, the end of the needle 45 is disposed inside the central orifice 64. The underside 60a of the plate 60 is preferably provided with a annular rib 70 surrounding the orifice 64 and projecting out of the face 60a. This secures the guide piece 42 on the bottle, the elastic tabs 58 cooperating with the underside 24 of the collar while the rib 70 is applied to the plug. We obtain a perfect fixation and a good seal between the plug and the guide piece by the action of the rib on the elastic material forming the stopper of the bottle. Preferably also, without this being necessary, it is possible to fix on the face 60a of the plate 60 a perforable membrane 72 ensuring the tightness of the internal area 76 of the guide piece, and therefore the sterility of space 76 containing the needle.

We understand that, thanks to the presence of elastic tabs 58, the fastening of the guide piece is automatically obtained on the neck of the bottle due to the depression of the neck of the bottle in the end of the guide piece, without the need to do no further action. The tabs 58, due to their elasticity, are automatically activated.

We would not depart from the invention if the guide surface 54 was deleted. In this case it would be necessary to give the surface 52 a length sufficient, for example 5 mm, in the direction of the axis XX 'so that, alone, it ensures the positioning of the guide piece on the bottle.

FIG. 4b shows an alternative embodiment of the surface of guide 52, and possibly the guide surface 54. It allows to achieve a very good centering of the guide piece 42 on the bottle despite the dimensional tolerances of the bottle. We plan on the face internal 52a of the guide surface at least one longitudinal rib 53 and preferably three arranged at 120 degrees in cross section triangular or the like. The edges of these ribs can crush partially according to the effective diameter of the cylindrical body or the flange while maintaining centering.

Figure 2 shows, in dotted lines, another alternative embodiment of the guide piece. According to this variant, the perforable membrane 72 is replaced by a film 73 (shown in the figure in dotted line) whose periphery is tightly fixed on the workpiece guide 54. This very thin waterproof film has in its center of the primers of tear. When setting up the guide piece on the bottle, the bottle cap exerts a pressure on the film 73 causing it to tear in its center. Thus the needle can freely cross it.

To maintain the sterility of the internal area 76 of the guide piece, the internal face of the zone can also be fitted guide 52 of a thread. Removable hood with external filtering can then be aimed at the end of the guide piece.

The syringe 44 is guided in translation inside the part current of the guide piece by an annular seal 78 which has on its external face 78a, preferably, three ribs sealing 80, 82 and 84 cooperating with the guide piece. The face internal 78b of the seal 78 has a shoulder 86 cooperating with the body of syringe 44. Consequently, the seal is driven by the syringe when it is inserted into the guide piece. In however, the seal is free from the syringe when moving this to extract it from the guide piece. Preferably, the end 48 of the guide piece comprises elastic strips 90 making protrusion inside the guide piece. In the storage position shown in Figure 2, the ends of the elastic strips 90 are interposed between the ribs 82 and 84 ensuring a certain immobilization of the seal 78 relative to the guide piece. So, we actually obtains a mechanical connection between the syringe and the guide piece via the seal 78 which, moreover, ensures a dynamic seal between the guide piece and the body of the syringe. As also shown in Figure 2, preferably the guide piece 42 has on its external face a flange 92 which protects the fingers of the manipulators when refitting initial place of the syringe inside the guide piece after its use.

Figure 5 shows an alternative embodiment of the guidance. This variant consists only of another mode of realization of the plate 60 and the sleeve 62. According to this mode of embodiment, the plate element which is then referenced 60 ′ comprises a cylindrical sleeve 96 defining an axial bore 97 of large dimensions. In this axial bore is engaged an insert 98. This part 98 includes a plate portion 100 provided with the rib 70 '. The insert 98 also includes a part forming a sleeve 102 which is engaged in the cylindrical sleeve 96. The sleeve 102 has a frustoconical end 104 and the central orifice 105, as well as the sleeve 62 included a frustoconical end 66. It is understood that, when the insert 98 is placed in the sleeve 96, a structure is reconstructed which is identical to that shown in Figure 2. The advantage of this solution consists in the fact that in the preliminary operations of the syringe device, we first put the syringe 44 in place in the guide piece 42 without the latter is still equipped with part 98, then we set up part 98 by the first end of the guide piece.

Figures 6a to 6b illustrate the use of the syringe. In Figure 6a, there is shown on the one hand the device for syringe 40 and on the other hand the vial 10 with its perforable cap 26.

In Figure 6b, there is shown the establishment of the device syringe 40 on the bottle 10. The guide piece 42 is perfectly positioned relative to the bottle and therefore relative to the cap thanks to the guide surfaces 52 and 54. In addition, the clip tabs 58 by cooperating with the flange 18 of the bottle ensure the joining of these two pieces.

Figure 6c shows the insertion of the syringe into the guide 42. This depression is controlled by the presence of the seal 78. The needle 45 perforates the plug 26 in its center. It is then possible by actuating the plunger of the syringe to penetrate the liquid which it contains in bottle 10. After mixing the two products, draw up the mixture thus prepared using the syringe. Just extract the syringe 44 outside the guide piece 42, the seal 78 remaining trapped in the guide piece thanks to the presence of the tabs elastic 90.

In addition, in these first two embodiments, the guidance in translation of the syringe in the guide piece is produced by the gasket 78 which also provides sealing and therefore maintenance sterility of volume 76 containing the needle. This dual function could be obtained by providing that the syringe body 44 has itself annular ribs, for example three, offset axially which cooperate with the internal face of the current part of the guide piece.

Referring now to Figure 7, we will describe a third embodiment of the syringe device. It stands out from the first essentially by the fact that the seal 78 is removed and that the translational guidance of the syringe 44 in the guide piece 40 is obtained by specific means. The rest of the device being identical in both cases, it will not be described again.

Translation guidance is provided by the cooperation of guide surfaces internal to the guide part with certain body portions 47 of the syringe. In the example illustrated by the figure 7, the end of the body 47 on which the needle 45 is mounted has a nozzle 120, a cylindrical portion of reduced diameter 122 and a cylindrical portion 124 of diameter greater than that of the portion current from the syringe body.

The internal face 50a of the current part 50 of the piece of guide has a diameter slightly greater than the outer diameter of the portion 124 of the syringe body, thus forming a first guide surface. Inside the guide piece are provided four radiating guide fins 126 whose edges 126a are arranged on a cylindrical surface of revolution whose diameter is slightly higher than that of the portion 122 of the syringe body. This defines a second guide surface. The distance between these two guide surfaces is sufficient to ensure very good guidance in translation of the syringe in the guide piece and therefore a perfect centering of the needle 45 relative to the plug 26.

It goes without saying that we could only plan one surface to provided that it is of sufficient length.

We also observe that the upper end 126b of the fins 126 constitutes a stop for driving the syringe by cooperation with the large diameter portion 124 of the syringe body. This stop ensures that, after having inserted the syringe into the guide part, the tip of the needle 45 has passed through the stopper 26 of the bottle but that it penetrates very little in the bottle. In addition, in this figure, there is shown at the upper end of the leg guide piece 130 forming reversible clips capable of cooperating with the shoulder 124a of the syringe body. These legs 130 are intended to ensure the effective fastening in translation of the syringe and the piece of guidance when the syringe is fully inserted into the workpiece guidance. This makes handling of the rod more comfortable. syringe plunger control to inject the contained liquid into the syringe and to draw the mixture out of the vial.

In FIG. 7, another improvement has been shown which could also be implemented in the two previous modes of achievement. This improvement concerns the recovery of gases harmful which can possibly leave the bottle after the mixture of compounds. Indeed, due to the overpressure which can result from the mixing in the bottle and temporary deformation and local stopper when the tip of the needle comes out of the stopper, harmful gases or a residual fraction of liquid can enter the guide piece and escapes into the surrounding air.

To solve this problem, we can use the first end of the guide piece a piece 140 of a porous material such as porous foam. When pulling the needle out of the bottle, the gases possibly leaving the bottle are absorbed, trapped or blocked by part 140. Of course, part 140 is crossed by the needle.

It is also possible, for this same purpose, to provide in the wall of the guide piece 40 an orifice blocked by a microporous filter 142 to compensate for the overpressure created by the gas outlet by filtering these gases out of the guide piece without their components toxic. This last provision is particularly interesting if the amount of gas created is important.

This filter is also used to compensate for pressures inside and the outside of the guide piece during movements of the syringe in the guide piece.

It should be added that the syringe device according to the invention not only ensures rigorous coaxiality of the needle the syringe and the vial, but also to rigorously position the guide piece relative to the bottle in the direction of the axis XX '. To control the insertion of the needle into the bottle, it suffices to check the insertion of the syringe into the guide piece. This result can be obtained automatically by providing a stop limiting the insertion of the syringe into the guide part.

Claims (20)

1. A syringe device suitable for fixing on a flask (10) that has a cylindrical body (12), an opening surrounded by a flange (18) presenting a side face and a puncturable plug closing said opening and that comprises a guide part (42) suitable for co-operating with said flask (10), and a syringe (44) provided with a needle (45) and mounted to slide in said guide part, said guide part including an open first end (46) having at its terminal portion a first internal cylindrical guide surface (52) suitable for co-operating with the cylindrical body (12) of said flask over sufficient length, a second internal guide surface (54) suitable for co-operating with the side wall of the flange (18) of the flask (10), and fastening means (58) for fastening said part to said flange, which means are different from said guide surfaces and set back relative to said first internal guide surface, said fastening means being activated while said device is being put into place on said flask, said guide part including a second end (48) and a common portion (50) suitable for receiving said syringe provided with means (78) for providing guidance in translation to said syringe in said guide part in order to bring said syringe into an engaged position in which its needle punctures the puncturable membrane of the flask, said device being characterised in that said guide part is made of a single element and that it presents means defining a central orifice of reduced diameter inside which the end of the needle is disposed and allowing the end of said needle to pass through under the effect of said syringe moving in translation.
2. A syringe device according to claim 1, characterised in that said fastening means (58) are disposed between said first and second guide surfaces (52, 54).
3. A syringe device according to any one of claims 1 and 2, characterised in that said means for providing guidance in translation include sealing means (78) for providing sealing between the inside face of said guide part (42) and the body of said syringe (44).
4. A syringe device according to claim 3, characterised in that said sealing means include a sealing ring (78) whose outside face (78a) co-operates with said guide part and whose inside face (78b) co-operates with said syringe body (44).
5. A syringe device according to claim 4, characterised in that said sealing ring (78) is constrained to move in translation with said syringe (44) while the syringe is being engaged into said guide part.
6. A device according to any one of claims 4 and 5, characterised in that said guide part (42) includes single-direction locking means (90) towards its second end and co-operating with said sealing ring (78) to hold said sealing ring and said guide part together and to allow said sealing ring only to be engaged in said guide part.
7. A device according to any one of claims 1 and 2, characterised in that said means for providing guidance in translation include annular ribs projecting from the syringe body (44) and co-operating with the inside face of said guide part (42).
8. A device according to any one of claims 1 and 2, characterised in that said means for providing guidance in translation include at least a first guide face formed in the inside face of said guide part to co-operate with a portion of the body of said syringe.
9. A device according to claim 8, characterised in that said means for providing guidance in translation include a second guide face formed in the inside face of the guide part for co-operating with another portion of the body of said syringe.
10. A device according to any one of claims 8 and 9, characterised in that said guide part further includes reversible snap-fastening means for temporarily securing said syringe to said guide part while said syringe is fully engaged in said guide part.
11. A device according to any one of claims 1 to 10, characterised in that the first end (46) of the guide part (42) is provided with an annular rib (70, 70') surrounding said central orifice (64) whereby said rib is pressed against plug (26) of said flask (10) when the fastening means (58) co-operate with said flask.
12. A device according to claim 11, characterised in that said definition means of said central orifice (64) include a plate element (60, 100) that is fast with said guide part disposed substantially perpendicularly to the direction of displacement of the syringe in which said central orifice (64) is formed, the face of said plate directed towards the first end of said guide part being provided with said projecting annular rib (70, 70') surrounding said central orifice.
13. A device according to any one of claims 11 and 12, characterised in that the fastening means include snap-fastening means (58) suitable for co-operating with the face (24) of the flange (18) of the flask opposite from its face that receives said plug.
14. A device according to any one of claims 1 to 13, characterised in that said central orifice (64) is defined by a part (98) that is added on and mounted in said first end (46) of the guide part, said add-on part including a sleeve-shaped portion (102) with one end that is flared, and a portion defining an annular rib surrounding said orifice.
15. A device according to any one of claims 1 to 14, characterised in that it further includes a puncturable membrane (72) closing said central orifice.
16. A device according to any one of claims 1 to 14, characterised in that it further includes a thin film (73) whose periphery is fixed in sealed manner to the inside wall of the first end of said guide part (42) in its portion which extends between said fastening means (58) and said central orifice (64), said film having tear starters, whereby said film is opened under the action of the plug (26) of said flask when the syringe device is mounted on said flask.
17. A device according to any one of claims 1 to 14, characterised in that it further includes a removable cap fixed in said first end (46) of the guide part.
18. A device according to any one of claims 1 to 17, characterised in that said guide part includes abutment-forming means to limit the extent to which said syringe can be engaged in said guide part.
19. A device according to any one of claims 1 to 18, characterised in that said guide part further includes, facing said orifice, a part made of porous material.
20. A device according to any one of claims 1 to 19, characterised in that said guide part includes in its side wall an opening that is closed by a microporous filter.

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