FR2705240A1 - Syringe device for mixing two compounds - Google Patents

Abstract

The invention relates to a syringe for injecting a mixture of two compounds, one of which is preferably a freeze-dried compound and the other of which is a liquid. According to one embodiment, the syringe comprises an outer body (10) which is provided with a perforable clamp (102) and in which the freeze-dried compound (112) is placed in a volume (110). It also comprises an inner body (120) closed by a perforable membrane (126) which cooperates with the clamp (102). It comprises a rod (140) which can act on a piercing member (134) and which can be solidly attached to an inner plunger (144) for passing the liquid contained in the zone (150) to the zone (110).

Description

SYRINGE DEVICE FOR MIXING
TWO COMPOUNDS
The present invention relates to a syringe device allowing the mixing of two compounds and the injection of the mixture thus obtained.

 More specifically, the invention relates to a device which allows the storage in separate form of two compounds which must be mixed before their injection, the mixing of these two compounds in controllable proportions and the injection of the mixture thus produced.

 It is known that there are, in particular in the medical field, products which must be stored separately and which must not be mixed until their injection into a patient by subcutaneous, intravenous or intramuscular route. This is in particular the case of medicinal products which are prepared in lyophilized form, therefore in powder form, and which must be mixed with a solvent, for example physiological saline, to allow their administration to the patient.

 The most frequently used solution consists in storing the powder in a container closed by a waterproof membrane which can be perforated using a needle. Using a syringe pre-filled with a certain amount of solvent, the desired amount of solvent is injected into the container, through the membrane. The whole is then mixed in this container and, using the same syringe, the mixture is aspirated. The syringe is then ready to inject the medicine.

 In other cases, the two compounds to be mixed can be liquids, these liquids not being able to be kept for a long time in mixed form.

 The solution described above has many drawbacks: on the one hand, it requires the use of the container closed by the perforable membrane and the syringe, which complicates handling. On the other hand, the storage means are more expensive.

Finally, the aseptic conditions are not always easy to respect during the various manipulations.

 An object of the present invention is to provide a syringe device allowing the storage of the two compounds, the mixing of these compounds and their injection to a patient.

 To achieve this aim, the syringe device allowing the mixing of two compounds, at least one of which is liquid, comprises an elongated hollow external body of which a first end can be opened to allow the mixture to be delivered and whose second end is open, characterized in that said external body comprises means forming a sealed plug displaceable in said external body to enclose in the internal volume of said external body a first compound, said plug means being perforable, and in that said device further comprises an internal body having a first perforable end, said internal body being capable of being slidably inserted into said external body and intended to receive said second liquid compound, said internal body comprising movable means for causing perforation of said plug and / or of said first perforable end, and mobile means mounted in said internal body and forming internal piston for, after said perforation, at least partially passing said second liquid compound from said internal body into said external body.

 According to a first embodiment, the stopper means are constituted by the first end of the internal body when the internal body is engaged in the external body.

In this case, preferably, the internal body comprises a mobile rod having a first end and a second end accessible from the outside of the internal body, the first end of the mobile rod is extended by said perforation means, said piston-forming means internal being provided with means for securing with the first end of the movable rod and, in the initial state of the device, the internal piston is disposed near the second end of the internal body, the liquid being placed in the internal body between the internal piston and the first end of the internal body
In this first embodiment, during storage, an effective separation of the two products is obtained because the end of the internal body has no orifice. To use the syringe device, firstly, using the movable rod, the first perforable end of the internal body is pierced, then the rod is withdrawn until the latter comes to join with the internal piston, then in a third step, the rod is pressed, which causes under the effect of the displacement of the piston the passage of the liquid in the external body through the previously made perforation.

 In this case, after the lyophilization step of the compound contained in the external body, it is necessary to assemble the internal body under vacuum.

 To simplify the packaging and sterilization steps, according to a second embodiment of the syringe device, the stopper means are distinct from the first end of the internal body and the first end of the internal body comprises means for cooperation with the first end of the internal body when the first end of the internal body is introduced into the external body.

 According to this embodiment, the manufacturing and the sterilization are carried out separately, on the one hand, for the external body provided with its cap and which contains the product to be lyophilized and, on the other hand, for the internal body which contains the liquid. which must be mixed with the lyophilized product for the injection of the mixture. It is understood that on one side the product can be lyophilized according to the usual techniques, the external body with its cap behaving like a conventional sealed container The external body with its cap and the liquid contained in the internal body can also be sterilized separately according to classical techniques. In view of its use, when the internal body is introduced into the external body and the end of the internal body cooperates with the plug, a structure is reconstituted, the operation of which is identical to that of the first embodiment.

 According to a preferred embodiment, the cooperation means are means for securing between the plug and the first end of the internal body.

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 longitudinal sectional view of a first embodiment of the syringe device, the latter being in its storage position;
- Figure 2 is a view of the syringe device of Figure 1 in an intermediate phase of its use;
- Figure 3 is a longitudinal sectional view of the outer body of a second embodiment of the syringe device in its position during production;
- Figure 4 is a longitudinal sectional view of the internal body of a second embodiment of the syringe device in its position during production;
- Figure 5 is a longitudinal sectional view of a variant of the second embodiment of the syringe device, the internal body being mounted in the external body;
- Figures 6 and 7 show the syringe device in two intermediate positions of use;
- Figure 8 shows a second variant of the internal body of the second embodiment of the syringe device; and
- Figure 9 shows a third alternative embodiment of the internal body of the second embodiment.

 Referring first to Figures 1 and 2, we will describe a first embodiment of the syringe device. This is constituted by an elongated external body 10 preferably of generally cylindrical shape, comprising a first end 12 closed and provided with a perforable passage 14 for mounting a needle. The second end 16 of the external body 10 is open and preferably has an external gripping flange 18, as in a conventional syringe. Inside the external cylindrical body, there is a piston assembly 20 which is preferably of cylindrical shape and in any case of shape cooperating with that of the external body 10.

 The piston 20 is mounted in leaktight and sliding manner in the external body 10. The piston 20 consists of an internal body which is therefore preferably cylindrical 22 which cooperates in leaktight manner with the external cylinder 10.

 The first end 24 of the internal body 22 is constituted by a membrane 26 impermeable to liquids and perforable. The membrane 26 is fixed by its periphery to the end of the tubular part of the internal body 22. The other end 30 of the internal body 22 is closed by a plug 32 which is at least liquid tight.

 Inside the internal body 22, there is a rod 34 which can slide along the axis of the internal body and which passes through the plug 32 through a passage 40. The cooperation between the rod 34 and the wall of the passage 40 ensures a seal liquids. The external end of the rod 34 is constituted by a plate 42. The other end 74 of the rod 34 is extended by a point 76 capable of perforating the membrane 26 when the point 76 is applied against the membrane 26 at the using the rod 34. The perforation obtained must have a sufficient section to allow the free passage of a liquid.

 In the internal body 22, there is also an internal piston 78. This piston is provided with a sealed passage 80 to allow the passage of the rod 34. The rod 34 can slide freely in the passage 80 but the cooperation between the wall of the passage 80 and the external face of the rod provides a liquid tightness. The same goes for the cooperation between the peripheral face 82 of the internal piston 78 with the internal face of the internal body 22. The internal face 84 of the internal piston 78 is provided with an elastically deformable clipping rib 86. The rib 86 can cooperate with latching lugs 88 formed on the rod 34 near its end 74. Finally, the rod 34 is provided with a retaining flange 90 which, coming into abutment on the external face of the plug 32, limits the penetration of the rod 34 into the body 22 'and thus maintains a certain distance between the tip 76 of the rod 34 and the perforable membrane 26. The flange 90 can be manually separated from the rod 34 for example by breaking it to release the rod from the internal body.

 We will now describe the instructions for use of the syringe shown in FIGS. 1 and 2.

 In its storage position illustrated in FIG. 1, the second compound, for example a lyophilized compound, is stored in the zone 50 between the end 12 of the external body 10 and the perforable membrane 26 of the internal body 22. The internal piston 78 is arranged substantially against the internal face of the plug 32 and the tip 76 of the rod 72 is kept away from the membrane 26 by means of the collar 90. The liquid is stored in the region 52 of the internal body 22 between the membrane 26 and the piston internal 78.

 To mix the two compounds, the retaining flange 90 is broken and the plate 42 of the rod 34 is pressed to cause the latter to sink until its tip 76 perforates 92 in the membrane 26. After this perforation, the rod 34 is withdrawn until the lugs 88 of the end of the rod engage in the clipping rib 86. The internal piston 78 is then secured to the end of the rod 34. It then suffices to press on the plate 42 to cause the displacement of the internal piston 78 in the internal body 22. Under the action of the internal piston, the liquid initially contained in the zone 52 passes through the membrane 26 by the perforation 92 and enters zone 50 where it mixes with the compound already contained in zone 50. This is illustrated in FIG. 2. If the volume of the liquid is greater than the volume of the initial zone 50, the internal body is gradually pushed back.

 The syringe is then ready for the user to inject. For this, it suffices to put the needle 94 in place, to break the collar 95 for limiting penetration, then to depress the whole of the piston 20 until all of the mixture contained in the zone 50 comes out by needle 94.

 Referring now to Figures 3 to 7, we will describe a second embodiment of the invention. As has already been succinctly indicated, in this embodiment, the external body 10 and the piston 20 'are produced separately. The external body 10 is identical to that which has been shown in FIG. 1. It has one end 12 provided with a perforable part 14 for receiving the needle and its second end 16 is open and preferably includes a flange of gripping 18. In its storage position, the external cylindrical body 10 is provided with a tight plug 102 disposed inside the external body 10. This plug cooperates in a sliding and sealed manner with the internal wall of the cylindrical body 10 by its side wall 104.

The plug 102 is made of a perforable material, such as butil.

The plug 102 comprises a cavity 106 provided with an internal thread 108. The plug 102 thus defines inside the external cylinder a sealed volume 110. This embodiment is particularly well suited to the case where the first compound 112 is a product which must be freeze-dried. For this, we start by placing the product 112 inside the volume 110 and we put in place the plug 102 near the open end 16 of the external body. Finally before the freeze-drying rupture, the plug 102 tends to lower before the vacuum rupture to substantially reach the position shown in Figure 3 at the end of vacuum rupture.

 In Figure 4, the piston 20 'is shown. This comprises a cylindrical internal body 120, one end 122 of which is open and the other end 124 of which is closed off by a perforable wall 126. It can also be seen that the first end 128 of the internal body is provided with an external thread 130 which can cooperate with the thread 108 of the plug 102 shown in FIG. 3. In this region of the internal body 120, a guide mandrel 132 has been provided for a piece 134 of perforation which is tubular in shape and which defines an axial passage 135 It has an end 136 capable of perforating the membrane 126 under the effect of a stress and a driving head 138. The piston 20 'also includes a rod 140 which can slide axially. This rod comprises a thrust plate 142 at its end disposed outside the internal body 120 and a second end 143 capable of exerting pressure on the driving head 138 of the part 134 by applying a thrust on the plate 142. The body internal 120 also includes an internal piston 144 which is slidably and frictionally mounted by its internal periphery 144a on the rod 140 and by its external periphery 144b on the internal face of the internal body 120. In addition, the internal face 144c of the internal piston 144 is provided with latching elements 146 with the end 143 of the rod 140. The internal space 150 of the internal body 120 which extends between the perforable membrane 126 and the internal piston 144 is intended to receive the liquid which must be mixed with the lyophilized product 112. It is understood that the liquid stored in the zone 150 can be subjected to treatments, for example sterilization without this risk of affecting r the lyophilized product 112 since the two parts of the syringe device are stored and handled independently. Preferably, the internal body 120 and the rod 140 are provided with breakable collars for limiting penetration similar to the collars 90 and 95 of FIG. 1.

 To use the syringe, the piston 20 'is mounted in the external body 10. For this, the end of the internal body 120 is secured to the plug 102. This attachment can be achieved by screwing the two threads 108 and 130 It can also be obtained by means of clipping the two parts or even by means of bonding. It is necessary that the joining operation of these two parts does not cause any significant component on the plug 102 in the axial direction of the two parts. When this connection is made, the perforable membrane 126 and the plug 102 which is also perforable are therefore placed side by side. In Figure 5, there is shown an improvement of the internal body which consists in the fact that the movable rod 140 is integral at its end close to the plate 142 with a cylindrical guide skirt 152 whose internal face cooperates with the external face of the internal body 122. This provides effective guidance of the rod 140 inside the internal body 120.

 In the next step which is illustrated in FIG. 6, the rod 140 is pushed in so that its end 143 comes to bear on the driving head 138 of the tubular part 134.

This perforates the membrane 126 and the central zone of the plug 102.

The part 134 being tubular, it thus ensures communication between the zone 110 inside the external body 10 and the zone 150 inside the internal body. To cause the effective passage of the liquid contained in the zone 150 towards the zone 110 of the internal body, traction is exerted on the rod 140 until its end 143 comes to snap onto the securing elements 146 of the internal piston 144 .

After this operation, the internal piston 144 is integral with the end of the rod 140. To mix the two products, it suffices to exert a push on the rod 140 to cause the passage of the liquid from the internal body to the external body, the liquid passing through the tubular part 134. It goes without saying that, if the quantity of liquid is large, this passage of the liquid will simultaneously cause the withdrawal of the assembly constituted by the plug 102 and the internal body 120. It is possible to then proceed to the actual mixing of the lyophilized compound and the liquid, then to the injection of this mixture.

 It is understood that by controlling the depression of the internal piston 144 in the internal body 120, the quantity of liquid which is passed from the internal body 120 to the external body 10 is determined through the passage 135 of the part 134. The quantity of liquid mixed with the lyophilized compound is thus measured. During the injection, the internal piston 144 remains stationary relative to the internal body 120. However, it cannot be totally excluded that, during the injection, a circulation of liquid develops in both directions through the passage 135 of the tubular part 134, which would cause a change in the composition of the mixture actually injected. To eliminate this risk, as shown in FIG. 8, it is advantageous to provide the piece 134 with a non-return valve 160, for example with a ball, which allows the liquid to flow in the passage 135 only towards the outside of the body internal 120. Thus, during injection, the increase in pressure in zone 110 of the external body causes the valve 160 to close.

 In the second embodiment described above, provision is made for the first end of the internal body to join the plug of the external body. It is understood, however, that this joining is not necessary. It suffices that the internal face of the perforable part of the plug 102 is in abutment and therefore cooperates with the external face of the perforable membrane 126 of the internal body. It can also be added that this joining can result from the fact that the tubular part 134, by perforating the plug 102 and the membrane 126, can make a mechanical connection in translation of these two parts.

 In addition, in the two embodiments of the invention, it is not necessary to provide for clipping of the internal piston on the end of the movable rod. FIG. 9 shows an alternative embodiment in which the internal piston 144 is connected to the rod 140 by a unidirectional connection constituted for example by a part 164, the piston 144 is integral with the rod when it is pressed in the body internal. On the contrary, if the rod 140 is pulled and the internal piston 144 is supported on a retaining ring 166 of the internal body, the rod can move freely relative to the piston. In its initial position, the piston 144 is supported on the retaining ring 166. In addition, as it is necessary to cause a slight depression of the rod to perforate the two membranes 126 and 102, it is necessary that the volume 150 does not is not completely filled with liquid to allow the displacement of the rod corresponding to the perforation since, during this operation, the internal piston 144 is driven by the rod 140.

This variant can of course be applied to the embodiment.
Figures I and 2.

Claims (15)

 1. Syringe device for mixing two compounds, at least one of which is liquid, comprising an elongated hollow external body (10), a first end (12) of which can be opened to allow the mixture to be delivered, and the second end (16) of which is open, characterized  in that said external body comprises means forming a sealed plug (102, 26) movable in said external body to enclose in the internal volume (50, 110) a first compound in said external body, said means forming a plug being perforable, and  in that said device further comprises an internal body (22, 120) having a first perforable end (26, 126), said internal body being capable of being slidably introduced into said external body and intended to receive said second liquid compound , said internal body comprising mobile means (34, 76, 140, 134) for causing the perforation of said plug and / or said first perforable end, and mobile means mounted in said internal body and forming internal piston (78, 144) for, after said perforation, at least partly passing said second liquid compound from said internal body into said external body.  2. Syringe device according to claim 1, characterized in that said stopper means are constituted by said first end (26) of the internal body (22) when said internal body is engaged in said external body (10).  3. Syringe device according to claim 2, characterized in that  said internal body (22) comprises a movable rod (34) having a first end and a second end accessible from the outside of the internal body,  said first end of the movable rod being extended by said perforation means (76), and  said internal piston means (78) are provided with means for securing (86) with the first end (88) of said movable rod, and  in that in the initial state of the device, said internal piston (78) is disposed near said second end (30) of the internal body, said liquid being disposed in said internal body between said internal piston and the first end of said body internal.  4. Syringe device according to claim 2, characterized in that  said internal body (22) comprises a movable rod (34) having a first end and a second end accessible from the outside of the internal body,  said first end of the movable rod being extended by said perforation means (76), and  said internal piston means (78) are provided with unidirectional fastening means (164) with the rod (140), said fastening means being active in the direction of depression of said rod, and  in that in the initial state of the device, said internal piston (78) is disposed near said second end (30) of the internal body, said liquid being disposed in said internal body between said internal piston and the first end of said body internal.  5. Syringe device according to claim 1, characterized  in that said plug means (102) are distinct from the first end of the internal body, and  in that said first end of the internal body (120) includes means (130) for cooperating with said plug means when said first end is introduced into said external body (10).  6. Syringe device according to claim 5, characterized in that said cooperation means are fastening means (130) in translation between said plug means (102) and said first end of the internal body (120).  7. Syringe device according to any one of claims 5 and 6, characterized in that the perforation means comprise a tubular member (134) having a perforating end (136), a driving head (138) and a rod movable (140) axially in said internal body having a first end (142) accessible from the outside of said internal body and a second end (143) capable of cooperating with the driving head of said tubular member.  8. Syringe device according to claim 7, characterized in that the piston means comprise an internal piston (144) whose internal periphery is sealingly mounted on said rod (140) and whose external periphery cooperates sealingly with the inner wall of said inner body (120) and means for securing (146) said inner piston with said second end (143) of the rod.  9. Syringe device according to claim 7, characterized in that the piston means comprise an internal piston (144) whose internal periphery is sealingly mounted on said rod (140) and whose external periphery cooperates sealingly with the inner wall of said inner body (120) and unidirectional fastening means (164) with said rod, said means being active in the direction of insertion of said rod.  10. Syringe device according to any one of claims 8 and 9, characterized in that, during manufacture, said internal body (120) is separated from said external body (10) and said internal piston (144) is not not integral with said rod (140) and is disposed in the vicinity of the second end of said internal body, said second liquid compound being stored in said internal body between its first end and said internal piston.  11. Syringe device according to any one of claims 7 to 10, characterized in that said tubular member (134) is provided with a non-return valve (160) not authorizing the circulation of the liquid through the passage of the tubular organ only from the internal body to the external body.  12. Syringe device according to any one of claims 7 to 11, characterized in that it comprises a guide skirt (152) one end of which is integral with the first end (142) of said rod (140) and which cooperates with the external face of said internal body (120), said skirt being disposed between said internal body (120) and said external body (10) when the internal body is engaged in the external body.  13. Syringe device according to any one of claims 3 to 12, characterized in that said movable rod (34, 140) is provided with means (90) for limiting the penetration of said rod relative to the internal body (22 ).  14. Device according to any one of claims 1 to 13, characterized in that said internal body (22, 120) and external (10) are cylindrical.  15. Device according to any one of claims 1 to 14, characterized in that it comprises means (95) for limiting the depression of the internal body (22) in the external body (10), said limiting means being apt to be broken.