Abstract:
The invention concerns a device for the two-way transfer of a liquid ( 38 ) between a bottle ( 14 ) provided with a cap ( 44 ) capable of being perforated at a cartridge ( 12 ) comprising a cylindrical reservoir ( 26 ) wherein slides a piston ( 34 ) capable of being perforated. It comprises: a body ( 16 ) including means to be fixed on the bottle ( 14 ); a member ( 24 ) linking the piston ( 34 ) capable of being perforated to the body ( 16 ); a shuttle ( 20 ) relative to the body ( 16 ) and said linking member ( 24 ), the shuttle bearing a hollow needle ( 22 ) whereof one first end ( 112 ) is adapted to pierce the piston ( 34 ) and whereof the second end ( 114 ) is adapted to pierce the cap ( 44 ). The shuttle ( 20 ) is mobile between a piston wherein the needle ends ( 112, 114 ) are spaced apart from the piston ( 34 ) capable of being perforated and the cap ( 44 ) capable of being perforated and an end-of-stroke transferring position wherein the needle ends ( 112, 114 ) are received in the cartridge ( 12 ) and the bottle ( 14 ).

Description:
BACKGROUND OF THE INVENTION 
     The present invention relates to a device for two-way transfer of a liquid between a bottle, provided with a perforable stopper, and a cartridge, comprising a cylindrical reservoir in which a perforable piston slides. 
     Before proceeding with an injection using a syringe, it is common for the practitioner to have to mix the liquid contained initially in the syringe with a lyophilisate which is contained initially in a bottle provided with a perforable stopper. 
     To mix these extemporaneously, the practitioner first injects all of the liquid contained in the syringe into the bottle. To this end, he perforates the stopper of the bottle with the aid of the needle which is provided on the syringe and is intended for the injection proper. 
     After the lyophilisate has dissolved in the liquid, the mixture obtained is reaspirated into the syringe through the injection needle. After the needle has been removed from the bottle, the injection proper on the patient is carried out. 
     Carrying out this extemporaneous mixing using such means is relatively awkward, and it also poses the risk of the injection needle being contaminated upon its introduction into the bottle. 
     Devices are also known for transferring fluid between a bottle and a flexible bag intended in particular for transfusion. However, these devices are not designed to permit two-way transfer of a liquid between a bottle and a syringe. 
     SUMMARY OF THE INVENTION 
     It is an object of the invention to make available a solution to the problem of two-way transfer of a liquid between a bottle and an injection syringe by making available a device which is easy to use and which guarantees satisfactory aseptic conditions. 
     To this end, the subject of the invention is a device for two-way transfer of a liquid between a bottle, provided with a perforable stopper, and a cartridge, comprising a cylindrical reservoir in which a perforable piston slides, characterized in that it includes a body having means for fixing to the bottle, a member for connecting the perforable piston to the body, and a shuttle which is displaceable relative to the body and to said connecting member, the shuttle bearing a hollow needle of which a first end is adapted to perforate the piston and of which the second end is adapted to perforate the stopper, and in that the shuttle is displaceable between an initial position, in which the needle ends are spaced apart from the perforable piston and the perforable stopper, and a final transfer position, in which the needle ends are received in the cartridge and the bottle. 
     According to particular embodiments, the transfer device includes one or more of the following characteristics: 
     said member for connecting the piston to the body comprises means for fixing to the body and is movable relative to the body from an initial position, in which the fixing means are not in engagement with the body, and a final position, in which the fixing means are in engagement with the body, thus ensuring that the piston is connected to the body; 
     said member for connecting the piston to the body comprises a threaded protuberance for fixing it in a tapped recess in the piston; 
     said shuttle is mounted so as to slide in a conduit of said member for connecting the piston to the body; 
     said conduit has on the inside an abutment limiting the displacement travel of the shuttle; 
     it comprises a protective cap initially mounted on the body, which protective cap has means for fixing it to the reservoir of the cartridge; 
     the body has a continuation surrounding said shuttle and extending beyond the first end of the needle; 
     it comprises at least one abutment limiting the axial displacement of the reservoir relative to the connecting member, preventing removal of the piston from the reservoir; and 
     it comprises a cartridge support on which the reservoir of the cartridge bears axially, and in that one of the cartridge support and connecting member has at least one projection, forming said abutment, received in a longitudinal slit of the other of the cartridge support and connecting member, in order to limit their relative axial displacement between the reservoir and the connecting member. 
     The invention also relates to an injection kit including a device for two-way transfer as defined above, and a cartridge and a bottle, in which the cartridge is initially connected to the attachment member and the bottle is initially connected to the body. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     The invention will be better understood on reading the following description which is given solely by way of example and in which reference is made to the drawings, in which: 
     FIG. 1 is a longitudinal cross-sectional view of the transfer device according to the invention in its storage position; 
     FIGS. 2 and 3 are a longitudinal cross-sectional view and a perspective and partially cutaway view, respectively, of the transfer device in its initial phase of use; 
     FIG. 4 is a longitudinal cross-sectional view of the transfer device after the needle ends have penetrated into the bottle and the cartridge; 
     FIG. 5 is a longitudinal cross-sectional view of the transfer device during the phase of transfer of the fluid from the cartridge to the bottle; 
     FIG. 6 is a longitudinal cross-sectional view of the transfer device once all the liquid has been transferred to the bottle; 
     FIG. 7 is a longitudinal cross-sectional view of the transfer device when returning the mixture from the bottle to the cartridge; 
     FIG. 8 is a cross-sectional view of an alternative embodiment of the transfer device according to the invention; and 
     FIG. 9 is a partial perspective view of the connecting member of the device in FIG.  8 . 
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     The transfer device  10  shown in FIG. 1 is designed for two-way transfer of fluid bet ween a cartridge  12  and a bottle  14 . This device is generally of revolution about its longitudinal axis. It mainly comprises a body  16 , a protective cap  18 , a shuttle  20  bearing a hollow needle  22 , and a screw pusher or connecting member  24  intended to ensure axial securing of the movable piston of the cartridge  12  and the body  16 . 
     In FIG. 1, the transfer device  10 , equipped with the cartridge  12  and the bottle  14 , is shown in its storage position before use. 
     The cartridge  12  is intended for carrying out an injection after it has been withdrawn from the transfer device and is equipped with an injection needle and an actuating pusher. It comprises a cylindrical reservoir  26  which at the front has a narrowed neck  28  closed off by a perforable cap  30  supported by an a head  31 . The cap  30  is designed to be perforated by an injection needle mounted on the head  31  of the cartridge with a view to proceeding with an injection. 
     The rear end  32  of the reservoir  26 , at the opposite end from the head  31 , is closed of by a perforable piston  34  mounted so as to slide in a leaktight manner inside the reservoir  26 . The piston  34  has axially a recess  36  opening to the outside of the cartridge. This recess is tapped internally in order subsequently to allow screwed insertion of an actuating pusher with a view to injecting the liquid contained in the cartridge. 
     The piston  34  is made of a polymer material of given Shore hardness. 
     The cartridge  12  is initially filled with an injectable liquid  38 . 
     The bottle  14  comprises a glass body  40  with a neck  42  closed off by a perforable stopper  44 . The neck  42  has a peripheral rim  46  defining a shoulder  48 . 
     The perforable stopper  44  is made of a polymer material having substantially the same Shore hardness as the material from which the piston  34  is made. Thus, the piston  34  and the stopper  44  have the same resistance to engagement of a sharp point. The materials from which the stopper  44  and the piston  34  are made are advantageously the same. Moreover, their thicknesses measured on the axis X—X are substantially identical. 
     The bottle  14  is initially filled with a lyophilisate  50  constituting a medicinal substance in powder form. The oyophilisate  50  only partially fills the bottle. As is known per se, the bottle is sealed under vacuum so that the pressure inside the bottle is very much lower than the atmospheric pressure. 
     The body  16  has a conduit  60  passing axially through it from one end to the other. At one end, called the lower end, the conduit  60  defines a seat  62  for receiving the bottle. This seat has a countersink  64  for receiving the rim  46  of the bottle  14  in order to fix the latter. In particular, the countersink  64  is delimited by projections  66  defining profiles for fixing the bottle. They are designed to cooperate with the shoulder  48  delimited by the neck of the bottle. The projections  66  have ramps converging from the open end of the seat  62  so as to make it easier to introduce the bottle into the body. 
     At its other end, called the upper end, the conduit  60  has a cylindrical chamber  70  in which the shuttle  20  and the connecting member  24  are received. The chambers  62  and  70  are linked via an intermediate portion  74  of smaller diameter. 
     The chamber  70  has a diameter which is sufficient to allow the passage of the reservoir  26 . The total length of the chamber  70  and of the portion  74  is advantageously greater than that of the hollow needle  22 . 
     The portion  74  is partially closed, at its end which opens into the chamber  62 , by a membrane  75  which delimits an opening sufficient for the passage of the needle  22 . This membrane  75  partially covers the membrane  44  of the bottle  14 . 
     At its upper end, the body  16  has on the outside a shoulder  76  reducing the thickness of the body. This is designed for fitting the protective cap  18 . 
     The protective cap  18  generally has the form of a sleeve and defines a seat  78  which is able to receive the cartridge  16  and to be engaged from its open end partially about the body  16 . 
     It additionally comprises, on the outside, at its blind end, means  80  for fixing on the head  31  of the cartridge. As is shown in perspective in FIG. 3, the means  80  comprise a fork  82  delimited by two arms which define a notch  84  which extends radially and whose width corresponds to the diameter of the narrowed neck  28 . Behind the fork  82 , a chamber  86  is provided in the protective cap  80  for the purpose of receiving the head  31 . 
     The connecting member  24  has a tubular shape. It comprises a cylindrical side wall  90  delimiting a conduit  91 . It is closed off at an upper end by a threaded protuberance  92  projecting outward. This protuberance  92  is screwed inside the tapped recess  36  and thus ensures that the connecting member  24  and the piston  34  are axially secured. 
     The protuberance  92  is provided with an axial conduit  94  whose diameter corresponds substantially to the external diameter of the needle  22 . 
     At its lower end, the connecting member  24  has, on the outer surface of its wall  90 , two successive grooves  96 A,  96 B which are spaced axially apart. They are separated by a distance I 1 . The grooves  96 A and  96 B are designed to cooperate with a peripheral flange  98  formed in the conduit  60  of the body. The flange is provided at the end of the intermediate portion  74  opening into the chamber  70 . 
     The groove  96  and the peripheral flange  98  are designed to secure the connecting member  24  and the body  16 . The flange  98  is initially engaged in the lower groove  96 A. 
     The distance I 1  is chosen to be smaller than the length of the intermediate portion  74 , less the thickness of the membrane  75 . 
     The wall  90  of the connecting member  24  has on the inside a peripheral flange  100  which delimits, in the space circumscribed by the wall  90 , a chamber  102  confining the shuttle  20 . Thus, the flange  100  forms an axial abutment for stopping the shuttle  20 . 
     The shuttle  20  is made up of a cylindrical slide  110 , with the hollow needle  22  passing axially through the latter from one end to the other. Thus, a first end  112  of the needle protrudes beyond the slide  110  and is received initially in the passage  94 . The second end  114  of the needle  22  protrudes rearward of the slide  110  and is initially arranged facing the stopper  44  of the bottle. 
     The two ends of the needles have analogous bevels, so that they have sharp points with the same profiles facing the piston  34  and the stopper  44 . 
     The diameter of the slide  110  is greater than the diameter of the passage defined by the membrane  75 . 
     The cylindrical slide  110  has, along a part of its length received in the confinement chamber  102 , longitudinal ribs  116  (FIG. 3) which define a shoulder  118  which is designed to cooperate with the peripheral flange  11  forming an abutment. The longitudinal ribs  116  guide the shuttle  20  in translation inside the connecting member  24 . 
     The length of the ribs  116  is smaller than the length of the confinement chamber  112  defined between the protuberance  92  and the flange  100 . This difference in length is labeled I 2 . 
     Initially, as is shown in FIG. 1, the connecting member  24  is free from the body  16 , so that the fixing means formed by the groove  96 A and the flange  98  are in engagement. Likewise, the shuttle  20  initially bears on the peripheral flange  100  by way of the shoulder  118 , so that the end  112  of the needle extends inside the protuberance  92 . It is thus spaced apart from the perforable piston  34 . The shuttle is then spaced apart by the distance I 2  from the protuberance  92 . 
     Likewise, the end  114  of the hollow needle is kept spaced apart from the stopper  44  by the lower end of the connecting member  24  bearing on the peripheral flange  98  and the shuttle  20  bearing on the flange  100 . The lower end of the slide  11  is then separated from the stopper  44  by a distance I 3 . 
     The distances I 1 , I 2  and I 3  are advantageously related to each other such that I 1 =I 2 +I 3 . 
     The transfer devise  10  is used in the following way. 
     The protective cap  18  is first pulled off and turned. The fixing means  80  are engaged about the head  31  of the cartridge, as is shown in FIGS. 2 and 3. 
     The protective cap  18  and the body  16  are then moved together in the direction of the arrow F 4 , as is shown in FIG.  4 . Upon this axial displacement, the shuttle  20  moves relative to the body  16  until a transfer position is reached in which the end  112  protrudes inside the cartridge  12  after passing through the piston  34  and the end  114  protrudes inside the bottle  14  after passing through the stopper  44 . 
     The displacement of the protective cap  18  in fact brings about the engagement of the cartridge  12  in the chamber  70  of the body. Upon this displacement, the connecting member  24  is displaced toward the bottle  14  by being pushed by the cartridge. The groove  96 A disengages from the peripheral flange  98  and the lower end of the member  24  is displaced until the flange  98  is received in the peripheral groove  96 B. The elastic engagement of the flange  98  in the groove  96 B ensures definitive axial securing of the connecting member  24  and the body  16 . 
     Upon displacement of the connecting member  24  along the course I 1 , the shuttle  20 , mounted so as to slide inside the connecting member  24  along a course of length I 2 , is also displaced relative to the body  16  and the member  24 . 
     In fact, at the start of the sliding of the connecting member  24 , the ends  112  and  114  of the needle come to bear respectively on the piston  34  and the stopper  44 . These latter then perforate the piston  34  and the stopper  44  simultaneously as the cartridge  12  and the bottle  14  are brought together. The ends of the needle then penetrate into the cartridge  12  and the bottle  14 . 
     As the Shore hardness values for the piston  34  and for the stopper  44  are identical, and likewise the two profiles of the ends  112  and  114  of the needle, the initial perforations of the piston and of the membrane are effected simultaneously, the needle being stressed only at these two ends. 
     At the end of displacement of the connecting member  24 , the slide  110  comes into abutment, on the one hand, on the end protuberance  92  of the connecting member and, on the other hand, against the membrane  75  extending over the stopper  44  which closes the bottle. In this position, shown in FIG. 4, the hollow needle  22  ensures communication between the bottle  14  and the cartridge  12 . 
     As is illustrated in FIG. 5, when the reservoir  26  is subsequently engaged in the body  16  under the action of the protective cap  18  displaced toward the body  16  in the direction of the arrow F 5 , the liquid  38  initially contained in the cartridge  12  is gradually transferred into the bottle  14 . 
     This transfer results from the engagement of the piston  34  inside the cylindrical reservoir  26 , the piston  34  being held fixed in relation to the body by way of the connecting member  24  which thus forms an abutment while the reservoir  26  is displaced toward the body  16 . 
     Filling the bottle  14  is made possible because it is initially at a pressure below atmospheric pressure. 
     When, as is shown in FIG. 6, the piston  34  is bearing against the neck  28  of the cartridge, most of the liquid initially contained in it is transferred into the bottle  14 . 
     After sufficient shaking, the lyophilisate  50  dissolves in the liquid  38  inside the bottle  14 . 
     To transfer the extemporaneous mixture thus formed to the inside of the cartridge  12 , the transfer device  10  is turned around, as is shown in FIG. 7, then the protective cap  18  is removed from the body  16  and the extemporaneous mixture is aspirated into the cartridge. 
     During the pull exerted on the cylindrical reservoir  26  of the cartridge in the direction of the arrow F 7 , the piston  34  is kept integral with the body  16  by way of the connecting member  24  fixed to the body through the cooperation of the groove  96 B and the peripheral flange  98 . 
     The mixture is aspirated under the action of the movement of the cylindrical reservoir  26  relative to the piston  34 . The relative movement of the piston and of the reservoir in fact creates an underpressure inside it, which leads to aspiration of the mixture contained in the bottle  14 . 
     After the cartridge  12  has been filled completely with the extemporaneous mixture, the cartridge  12  is detached from the connecting member  24  by being unscrewed. It can then be used for injection purposes after being fitted with an injection needle and an actuating pusher. 
     The transfer device thus without the cartridge is then discarded. It should be noted that in this position the end  112  of the needle is protected on account of the continuation of the body  16 , thereby avoiding any risk of accidental needle stick injuries. To this end, the length of the body  16  is chosen to be sufficient to continue beyond the end  112  of the hollow needle. 
     The device according to the invention permits a transfer of the liquid between the cartridge and the bottle without any risk of contamination of the liquid. This is because the two ends of the hollow needle are at all times protected inside the closed space delimited by the connecting member  24 , the body  16  and the bottle  14 . 
     This protection is further reinforced by the presence of the protective cap  18  during storage of the device. 
     Moreover, the simultaneous penetration of the two ends of the needles avoids any risk of ambient air entering the cartridge or the bottle. 
     When the transfer device is pre-fitted with a bottle  14  and a cartridge  12  before delivery, the transfer can be carried out without any need for the cartridge or the bottle to come back into contact with the hand. This eliminates any risk of contamination from the hands. 
     An alternative embodiment of the transfer device according to the invention is shown in FIGS. 8 and 9. In this figure, the elements which are analogous or identical to those of the embodiment in FIGS. 1 through 7 are designated by the same reference numbers. 
     This figure shows a transfer device  200  combined with a cartridge  12  and a bottle  14  containing a lyophilisate. 
     The transfer device  200  comprises a body  16  in which the bottle  14  is axially immobilized, a connecting member  24  which slides relative to the body, and a needle-holedr shuttle  20  which slides freely along the axis of the connecting member  24 . 
     The transfer device  200  additionally comprises a cartridge support  202  which has means  203  for axially fixing the cap  18 . 
     In this embodiment, the connecting member  24  includes, in addition to the cylindrical wall  90 , a coaxial outer sleeve  204  which surrounds the cylindrical wall  90  and is connected to it by an annular wall  206 . The sleeve  204  is mounted so as to slide inside the body  16 . It has raised and recessed profiles  208  designed to cooperate with complementary profiles provided on the side wall of the body  16  in order to axially secure these after perforation of the stopper  44  by the end  114  of the hollow needle. 
     The sleeve  204  continues beyond the threaded protuberance  92  screwed into the piston  34  of the cartridge. 
     As is shown in FIG. 9, the sleeve  204  has, in its side wall, two pairs of longitudinal slits  210 ,  212  offset by an angle of 90°. The slits  210  have a length twice that of the slits  212 . The lower end of the two pairs of slits  210 ,  212 , arranged toward the bottle  14 , extend at the same level on the sleeve  204 . 
     The cartridge support  202  comprises an inner tube  220  for receiving the body  26  of the cartridge. It is partially closed at its lower end by a shoulder  222  on which the open end of the reservoir  26  of the cartridge bears axially. The shoulder  222  is continued by a tubular portion  224  sliding along the cylindrical wall  90  of the connecting member. In addition, the tube  220  is surrounded in its lower part by a coaxial sleeve  230  bearing two diametrically opposite projections  232  which are designed to slide inside one or other of the pair of slits  210 ,  212 . 
     Depending on the capacity of the cartridge  12  used with the transfer device, the projections  232  are introduced into one or other of the pairs of slits. For a cartridge with a capacity of 1.3 mm, that is to say a cartridge having a body of reduced length, the projections  232  are arranged in the short slits  212 . 
     By contrast, when the transfer device is used with a cartridge having a capacity of 2.3 ml, that is to say a cartridge in which the length of the body is twice that of a cartridge of 1.3 ml, the projections  232  are engaged in the slits  210 . 
     It will be appreciated that the cartridge support  202  guides the cartridge  12  axially as it slides relative to the connecting member  24 . The presence of the two pairs of slits on the sleeve  204  of the connecting member makes it possible to use the same transfer device with cartridges of two different capacities. 
     After the liquid contained initially in the cartridge has been transferred to the inside of the bottle and it has been mixed with the lyophilisate, the mixture thus obtained is reaspirated into the cartridge  12  through the needle. For this purpose, the reservoir of the cartridge is pulled using the cap fixed to the needle support  202 . When the mixture is transferred to the cartridge  12 , the projections  232  slide along the slits  210  or  212 . When the projections  232  come into contact with the end of these slits, the latter form an abutment and oppose subsequent displacement of the cartridge  12 . Thus, any risk of the piston  34  being withdrawn from the reservoir of the cartridge on account of too great a displacement of the latter is avoided by the presence of the projections  232  forming an abutment. This is because these limit the course of displacement of the reservoir of the cartridge relative to the connecting member  24  secured to the piston.