Abstract:
A device connecting a recipient closed by a perforatable stopper and a container for a needle, comprising a base for mounting the container, the base defining a central bore and comprising means for mounting on the recipient, the needle pertaining to a subset engaged in the central bore forming part of the device, for mounting on the container, and being arranged in the central bore parallel to the bore&#39;s longitudinal axis, and a sealing sleeve arranged in the central bore, around the needle and in contact therewith, the base being a single component and comprising a body for perforating the stopper extending from an intermediate wall of the base, away from the central bore and parallel to its central axis, up to a distal end, the perforating body being hollow and the inner space thereof communicating with the central bore and with a space radially surrounding its distal end.

Description:
CROSS-REFERENCES TO RELATED APPLICATIONS 
       [0001]    This application claims priority benefit under 35 U.S.C. §371 to International Patent Application No. PCT/EP2012/060591 entitled DEVICE FOR CONNECTION BETWEEN A RECIPIENT AND A CONTAINER AND METHOD FOR ASSEMBLING AND USING SUCH A DEVICE, and filed by inventor Antoine Aneas on Jun. 5, 2012. International Patent Application No. PCT/EP2012/060591 claims priority to French Patent Application No. 11 54884, filed by inventor Antoine Aneas on Jun. 6, 2011. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The invention relates to a device for a connection between a recipient provided with a neck closed off by a penetrable stopper and a container intended to be equipped with a needle, such a container for example possibly being a syringe. The invention also relates to a method for assembling such a connection device as well as a method for filling a container intended to be equipped with a needle, in which such a connection device is used. 
       BACKGROUND OF THE INVENTION 
       [0003]    In the field of medicament packaging, it is known to store a freeze-dried medicament or the active ingredient of a medicament in a glass bottle, the neck of which is closed off by an elastomer stopper and crimped by an aluminum cap provided with a closure that can be torn. To reconstitute such medicaments, is known to eject the contents of the syringe into the bottle, then to recover the mixture. To that end, an equipment may be used like that described in WO-A-2006/085327, the implementation of which is relatively long and complex, inasmuch as certain manipulations, including rotations, must be done in a specific order that is not necessarily intuitive for an uninformed user. Furthermore, the known devices comprise a relatively large number of parts, which increases their cost and manufacturing time. 
         [0004]    FR-A-2 717 086 provides for connecting a bottle to a syringe already equipped with a needle by using a guide piece that includes a cylindrical body. A fastening piece is part of a proximal end of the cylindrical shaft whereof the distal end is guided by a sleeve and forms a tip intended to penetrate a piece mounted in an end portion of the cylindrical body. This distal end is not secured to the sleeve but to the fastening piece, such that the stopper may only be penetrated by inserting the syringe provided with its needle inside the connecting device. This material therefore does not make it possible to access the inner volume of the bottle when the syringe is not in place. Furthermore, a part made from an elastic material provides sealing between the end of the syringe and the fastening piece, without coming into contact with the needle. As a result, the dead space of that material extends to the nose of the syringe, which causes significant product losses. 
         [0005]    Furthermore, GB-A-2 446 778 discloses an adapter that is intended to cooperate with a standard syringe provided with a needle, which is not compatible with the use of a syringe without a needle. The risks of leakage around the middle of the syringe are significant, in particular when an assembly formed by a bottle, an adapter and a needle is positioned in the upside down configuration to pour the contents of the bottle into the needle. 
       SUMMARY 
       [0006]    The invention more particularly aims to resolve these drawbacks by proposing a new connection device that is cost-effective and particularly easy to use. 
         [0007]    To that end, the invention relates to a device for connection between a recipient provided with a neck closed off by a penetrable stopper and a container intended to be equipped with a needle, said device comprising a base provided with means for assembly on the recipient, which defines a central bore and on which the container can be mounted. According to the invention, a needle, belonging to a subassembly engaged in the central bore of the base that is part of the connection device and intended to be mounted on the container, is positioned in the central bore, in a direction parallel to a longitudinal axis of the bore, whereas a sealing sleeve is positioned in the central bore, around the needle and in contact therewith, the base being a single component and comprising a member penetrating the stopper that extends, from an intermediate wall of the base, opposite the central bore, parallel to its central axis and as far as the distal end, whereas the penetrating member of the stopper is hollow and its inner volume is in communication with the central bore, on the one hand, and with a volume radially surrounding the distal end of the penetrating member, on the other hand. 
         [0008]    Owing to the invention, the connecting device according to the invention may be implemented owing to translational movements, without requiring rotation or complex movements, which is completely intuitive for a user. Furthermore, inasmuch as the needle provided to equip the container is positioned in the central bore of the base, the device according to the invention is compact and effectively protects the needle before use. In particular, the device according to the invention is compatible with the use of a syringe with no needle, since the subassembly to which the needle belongs is engaged in the central bore of the base. Since the base is a single component, the penetrating member may be provided to penetrate the stopper of the recipient due solely to the placement of that base on the neck of the recipient. The structure of the device according to the invention is also simple, which makes it possible to control its cost and manufacturing time. 
         [0009]    According to advantageous, but optional aspects of the invention, such a device may incorporate one or more of the following features, in any technically allowable combination:
       The inner volume of the penetrating member forms a housing for partially receiving the needle.   The part of the needle that is received in the inner volume of the penetrating member is not in contact with that member.   The free end of the part of the needle received in the inner volume of the penetrating member is offset, in a direction parallel to the longitudinal axis of the bore, by at least 2 mm relative to the distal end of the penetrating member.   The minimum inner diameter without strain of the sleeve is smaller than the outer diameter of the needle.   The base and a tip secured to the needle are provided with complementary raised portions for locking the needle in a translational movement parallel to the longitudinal axis of the bore, toward the penetrating member.   The sleeve bears, opposite the tip, against the bottom of the bore whereas, when the tip is locked against the base by cooperation of the complementary raised portions, it exerts an axial compression force on the sleeve and the sleeve is provided to expand radially under the effect of such a compression force.   The sleeve has a cylindrical outer shape with a circular base on one part, and a frustoconical shape on another part.       
 
         [0017]    The penetrating member is provided to penetrate the stopper of the recipient due solely to the mounting of the base on the recipient, without any interaction with the container.
       The dead space of the device extends into the inner volume of the penetrating member, into the sleeve as far as the narrow zone of that sleeve in contact with the needle and around the penetrating member.       
 
         [0019]    The dead space of the device is smaller than 25 mm 3 .
       The subassembly is provided with means for removable attachment on the container.       
 
         [0021]    The invention also relates to a method for assembling a device as described above that comprises the following steps:
       a) engaging, owing to elastic deformation, the sleeve on a tube whereof the inner diameter is larger than the outer diameter of the needle;   b) aligning a central axis of the needle on a central axis of the tube;   c) engaging the needle in the tube with a translational movement parallel to the aligned axes;   d) separating, through a translational movement parallel to the aligned axes, the tube and a subassembly comprising at least the sleeve and the needle; and   e) engaging the subassembly in the central bore of the base.       
 
         [0027]    Lastly, the invention relates to a method for filling a container intended to be equipped with a needle with a product contained in a recipient provided with a neck closed off by a penetrable stopper. According to that method, a connection device is used as mentioned above and the following steps are performed:
       p) mounting the base on the recipient by penetrating the stopper with the penetrating member, through an operation resulting from the movement of the base relative to the neck, in translation parallel to the central axis of the bore and toward the bottom of the recipient;   q) sealably mounting the container on a tip secured to a proximal end of the needle;   r) injecting, in the recipient, a liquid present in the container, through the central channel of the needle and the inner volume of the penetrating member;   s) positioning the recipient, the connecting device and the container assembled in a position where the contents of the recipient flow by gravity toward the inner volume of the container, through the inner volume of the penetrating member and the central channel of the needle; and   t) removing the needle secured to the container from the bore.       
 
         [0033]    It is in particular possible to provide that, during step p), the mounting means are elastically deformed and attach below the neck of the recipient, while keeping the penetrating member in a position where it puts the inner volume of the recipient in communication with the inner volume of a part of the subassembly in place in the central bore of the base. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0034]    The invention will be better understood and other advantages thereof will appear more clearly in light of the following description of one embodiment of a connection device according to its principle and methods implemented using the device, provided solely as an example and done in reference to the appended drawings, in which: 
           [0035]      FIG. 1  is an exploded perspective view in axial cross-section, over a quarter of its circumference, of a connection device according to the invention; 
           [0036]      FIG. 2  is an axial cross-section of the device of  FIG. 1  above a bottle whereof the neck is closed off by a penetrable stopper; 
           [0037]      FIG. 3  is a cross-section similar to  FIG. 2  when the connection device is mounted on the bottle; 
           [0038]      FIG. 4  is an exploded perspective view of the connection device, from another angle and in axial cross-section over its half-circumference; 
           [0039]      FIGS. 5 to 8  are side views showing the steps of a method for assembling the device of  FIGS. 1 to 4 , and 
           [0040]      FIGS. 9 to 13  show the steps of a method for reconstituting a medicament, in which a syringe is filled with a product contained in a bottle, using the device of  FIGS. 1 to 4 . 
       
    
    
     DETAILED DESCRIPTION 
       [0041]    The connection device  10  shown in  FIGS. 1 to 4  comprises a single-component base  20  made from a molded synthetic material, for example polycarbonate or ABS. 
         [0042]    This base  20  is provided with an annular part  21  from which four tabs  22  extend that are elastically deformable and the geometry of which allows them to be snapped around the outer collar  122  of the neck  120  of the glass bottle  110 . 
         [0043]    The tabs  22  define a volume V 22  between them for receiving the neck  120  when the device  10  is placed on the bottle  110 , as shown in  FIG. 3 . In this configuration, an inner beak  24  of each tab  22  bears against a lower flank  134  of a cap  130  that surrounds the collar  122 . This flank  134  in turn bears against a surface  124  of the collar  122  that is oriented toward the bottom  112  of the bottle  10 . 
         [0044]    The base  20  is provided with a central bore  26  whereof the longitudinal axis is denoted X 26 . The axis X 26  constitutes a central longitudinal axis for the base  20 . Four stiffening ribs  252  are formed on the outside of the tubular part  25  at the center of which the bore  26  is formed. The ribs  252  extend between the tubular part  25  and the annular part  21 . Reference  23  denotes the surface of the part  21  opposite the ribs  252 . The surface  23  is perpendicular to the axis X 26  and the tabs  22  extend parallel to the axis X 26 , from a skirt  27  that surrounds that surface. The volume V 22  extends as far as the surface  23  and it is surrounded, radially relative to the axis X 26 , by the skirt  27  near the surface  23 . The part of the volume V 22  closest to the surface  23  surrounds the collar  122  and the cap  130  in the configuration where the base  20  is mounted on the bottle  110 . 
         [0045]    The end of the part  25  opposite the part  21  is bordered by an outer collar  254 . 
         [0046]    The inner beaks  24  of the tabs  22  are each provided with a surface  242  oriented opposite the bore  26 . The surfaces  242  are frustoconical and divergent relative to the axis X 26  moving away from the bore  26 . This geometry of the surfaces  242  facilitates the elastic deformation of the tabs  22  during placement of the base  20  on the neck  120  of the bottle  110 , through an axial translational movement. 
         [0047]    A hollow punch  28  extends along the axis X 26 , in the volume V 22  and from the center of the surface  23 . The punch  28  is intended to penetrate a stopper  128  made from elastomer that closes off the neck  120 . In this sense, the punch  28  constitutes a penetrating member of the stopper  128 . 
         [0048]    In practice, the stopper  128  is immobilized in the neck  120  using the cap  130 , which is made from aluminum or a synthetic material. 
         [0049]    Reference  282  denotes the distal end of the punch  28 , i.e., the end thereof furthest from the surface  23 . Reference  284  denotes the base of the punch  28 , i.e., its junction zone with the surface  23 . This base constitutes the proximal end of the punch  28 . 
         [0050]    V 28  denotes the inner volume of the punch  28 , said inner volume being in the form of a bore centered on the axis X 26 . 
         [0051]    An opening  286  is formed on one side of the punch  28 , near the end  282 . This opening puts the volume V 28  in communication with the volume V 22  that surrounds the end  282 , radially relative to the axis X 26 . 
         [0052]    The device  10  also comprises a single-component sealing sleeve  40  made from a synthetic or flexible natural material, such as elastomer. Alternatively, the sleeve  40  is made from injection-moldable Santoprene. 
         [0053]    X 40  denotes the longitudinal axis of the sleeve  40 , and V 40  denotes the inner volume of said sleeve, which is centered on the axis X 40  and symmetrical relative to the axis. The diameter of the volume V 40  varies over the length of the sleeve  40 . More specifically, the sleeve  40  comprises a narrow zone  42  where its inner diameter has a minimum value d 40  when the sleeve  40  is not stressed by outside forces. 
         [0054]    The outer surface of the sleeve  40  comprises a cylindrical portion  44  with a circular section and centered on the axis X 40 , as well as a portion  46  that is frustoconical, centered on the axis X 40  and converging toward the axis moving away from the portion  44 . 
         [0055]    Opposite the narrow zone  42 , the volume V 40  emerges outwardly, by a wider portion  48 . 
         [0056]    The bore  26  comprises two portions  267  and  268  that are cylindrical and frustoconical, respectively, and converging toward the bottom  62 . The axial lengths of the portions  267  and  268  are respectively the same as those of the portions  44  and  46  of the sleeve  40 . 
         [0057]    The device  10  further comprises a subassembly  60  formed by a hollow needle  62  and a tip  64  mounted around the proximal end  624  of the needle  62 . The subassembly  60 . The subassembly  60  is engaged in the bore  26 , where it awaits connection with a syringe, as explained hereinafter. The tip  60  is provided to be mounted reversibly on a syringe. It may be a standard commercially available product, the cost of which is well-controlled. The needle  62  is made from metal, whereas the tip  64  is made from a plastic material, for example polypropylene. 
         [0058]    The tip  64  is provided with a collar  642  allowing it to be fastened to the end of the syringe  210 , like those traditionally used to reconstitute and inject medicaments. 
         [0059]    The inner volume V 64  of the tip  64  is in communication with the central channel  626  of the needle  62 . The elements  62  and  64  can be secured using any known technique, in particular by overmolding or gluing. 
         [0060]    X 60  denotes a longitudinal axis of the subassembly  60 . The elements  62  and  64  are aligned and centered on the axis X 60 . 
         [0061]    The tip  64  is provided with four fins  644  that extend toward the outside of the tip  64 , radially relative to the axis X 60 . On its side, the surface of the base  20  that defines the bore  26  is provided with raised portions  263  between which guideways  264  are defined for receiving the fins  644  when the tip  64  is engaged in the bore  26 , as explained hereinafter. 
         [0062]    The cooperation of the fins  644  and the guideways  264  prevents the subassembly  60  from rotating relative to the base  20  when the tip  64  is engaged in the bore  26 . 
         [0063]    The tip  64  is also provided with an outer shoulder  646  that extends between the fins  644  and bears against a surface  266  of each raised portion  263  that is opposite the bottom  262 . The cooperation of the shoulder  646  and the surfaces  266  limits the pushing of the tip  64 , and consequently of the needle  62 , into the bore  26 , toward the volume V 22 . 
         [0064]    In the assembled configuration of the device  10 , the axes X 26 , X 40  and X 60  are combined and the sealing sleeve  40 , in place in the bore  26 , rests against the bottom  262  by its end surface  49  opposite the portion  48 . In that configuration, the shoulder  646  rests on the surfaces  266  and the fins  644  exert a force E 1  on the sleeve  40  pressing the sleeve  40  against the bottom  262 . The bottom  262  then exerts a reaction force E 2  on the sleeve  40 . In other words, the sleeve  40  is compressed between the end surface  644 A of the fins  644  and the bottom  642 . This compression of the sleeve  40  results in radially expanding it relative to the axes X 26  and X 40 , which are then combined, which firmly presses the portions  44  and  46  of its outer surface against the surface defining the bore  26  inside the base  20 , at its portions  267 ,  268 , respectively. The sealing between the elements  20  and  40  is thus ensured lastingly. This sealing is obtained owing to the elastically deformable nature of the sleeve  40 , radially relative to the axis X 40 . 
         [0065]    In this fitting configuration, the needle  62  extends parallel to the axis X 26 . In practice, it extends along the axis X 26  and the distal end  622  of the needle  22  is engaged in the volume V 28 , without coming into contact with the inner surface of the punch  28 . The punch  28  therefore mechanically protects said distal end  622 , without any risk of pollution. 
         [0066]    In the fitted configuration shown in  FIGS. 2 and 3 , the distal end  622  of the needle  62  is offset, along the axes X 26  and X 60 , which are combined, by a length l 2  relative to the distal end  282  of the punch  28 . The length l 2  is greater than 2 mm, preferably greater than 3 mm, which makes it possible to reduce the dead space around the needle  62  when the bottle  1  equipped with the device  10  is turned over in the position of  FIG. 12 . 
         [0067]    When the device  10  is mounted on the bottle  110 , as shown in particular in  FIG. 3 , the punch  28  has penetrated the stopper  128  due to the engagement of the tabs  22  below the collar  122 , such that the volume V 28  communicates with the inner volume V 110  of the bottle  110 , through the opening  286 . Inasmuch as the distal end  622  of the needle  62  is positioned in that volume V 28 , the central channel  626  of the needle  62  thus communicates with the volume V 110 , through the volume V 28 , the opening  286  and the volume V 22 . In light of its single-component nature with the rest of the base  20  and in particular with the annular part  21 , the punch  28  is made to penetrate the stopper  128  due solely to the mounting of the base  20  on the recipient  10 , without interaction with a syringe or another member outside the device  10 . 
         [0068]    Thus, the device  10  makes it possible to put the channel  626  and the volume V 110  in communication, while protecting the distal end  622  of the needle  62  that is mounted on the base  20 , within the device  10 , before placing that device on the bottle  110 . 
         [0069]    D 62  denotes the outer diameter of the needle  62 , the diameter being constant over the length of the needle. The diameter d 40  is chosen to be smaller than the diameter D 62 . In practice, the difference between these diameters may be comprised between 5% and 25% of the diameter. This ensures effective sealed bearing between the sleeve  40  and the needle  62 , in the zone  42 . This also ensures, when the subassembly  60  is removed relative to the base  20  as explained hereinafter, wiping by friction of the outer surface of the needle  62 , at the level of its part received in the volume V 28 . 
         [0070]    As emerges from  FIG. 3 , in the configuration shown in figure, the dead space of the assembly formed by the device  10  and the bottle  110  comprises an inner volume part V 28  of the punch  28  and an inner volume portion V′40 of the sleeve  40  that extends between the volume V 28  and the narrow zone  42  of the sleeve  40  that is in contact with the needle  62 . This dead space also comprises a part V 128  of the inner volume of the stopper  128  that extends between the bottom of said stopper and the opening  286 . This dead space is shown grayed out in  FIG. 3 . It is substantially smaller than in the known materials, in particular because it practically does not extend above the punch  28 , since the narrow zone  42  is close to the lower end of the sleeve  40 . This dead space made up of the volumes V 28 , V′40 and V 128  has a value smaller than 25 mm 3 , in practice smaller than 22 mm 3  (cubic millimeters). A method for assembling the device  10  is shown in  FIGS. 5 to 8 . In this method, a tube  310  secured to a support  320  is used, as well as a plate  330  that is translatable relative to the support  320  and the tube  310 . 
         [0071]    The tube  310  is chosen such that its outer diameter D 310  is compatible with its insertion in the sleeve  40 , subject to elastic deformation thereof. The inner diameter d 310  of the tube  310  is chosen to be strictly larger than the diameter d 62 . 
         [0072]    In a first step shown in  FIG. 5 , the sleeve  40  is fitted around the part of the tube  310  that protrudes past the plate  330 . This is represented by arrow F 1  in that figure. 
         [0073]    In a second step shown in  FIG. 6 , the subassembly  60  is positioned relative to the sleeve  40  by aligning the axis X 60  with the central axis X 310  of the tube  310 , then the needle  62  is engaged in the tube  310 , which is possible owing to the difference between the diameters D 62  and d 310 . This operation is represented by arrow F 2  in  FIG. 6 . It occurs without any contact between the sleeve  40  and the needle  62 . 
         [0074]    In a third step shown in  FIG. 7 , the plate  330  is separated from the support  320 , in translation along the axis X 310  and the axis X 60 , as shown by arrow F 3 , which results in removing the tube  310  from the sleeve  40  then placed on the needle  62 . At the end of this step, the elements  60  and  40  are preassembled, and the distal end  622  of the needle  62  protrudes past the sleeve  40  without having been in direct contact therewith, therefore without any risk of pollution of that end  622  by the material making up the sleeve  40 . 
         [0075]    In a fourth step shown in  FIG. 8 , the base  20  is attached around preassembled elements  60  and  40 , as shown by the arrow F 4 . During the movement, the axes X 26 , X 40  and X 60  are aligned. The distal end  622  of the needle  62  is inserted as far as into the inner volume V 28  without coming into contact with the base  20 . 
         [0076]    In this respect, it will be noted that the minimum inner diameter d 28  of the punch  28  is larger than the diameter D 62 . In practice, the diameter d 28  may be between two and four times greater than the diameter D 62 . 
         [0077]    Before use, the device  10 , which is compact, may be stored in a blister  400 , as shown in  FIG. 9 . When the contents of the bottle  110  need to be recovered, the blister  400  is opened and the device  10  is mounted on the neck  120  of the bottle  110  by placing it on that neck, then exerting thrust toward the bottom  112  in the direction of arrow F 5  in  FIG. 2 . This makes it possible to transition the device  10  from the configuration of  FIG. 2  to that of  FIGS. 3 and 10 , subject to elastic deformation of the tabs  22 . This causes the stopper  128  to be penetrated by the punch  28 . 
         [0078]    It is then possible to mount, reversibly on the tip  64 , a syringe  210  that is equipped with a nut  214  for locking on the tip  64 . Locking of the luer or luer-lock type may be used. Alternatively, other types of locks may be considered. 
         [0079]    A thrust force E 3  may then be exerted on the piston  220  of the syringe  210 , which results in injecting a liquid contained in the syringe  210  inside the bottle  110 , as shown in  FIG. 11 . This is possible inasmuch as, by going from the configuration of  FIG. 2  to that of  FIG. 3 , the punch  28  has penetrated the stopper  128 , such that the liquid contained in the syringe  210  can flow through the volume V 64 , the channel  626 , the volume V 28 , the opening  286  and the volume V 22 , until reaching the volume V 110 . 
         [0080]    It is then possible to shake the elements  10 ,  110  and  210  thus connected and put in communication to homogenize the contents of the bottle  110 , then to turn that assembly over, as shown in  FIG. 12 , which allows the contents of the bottle  110  to flow by gravity toward the syringe  210 , by passing in the volume V 22 , the opening  286 , the volume V 28 , the channel  626  and the volume V 64 . In that position, the reconstituted product dead space is that which surrounds the needle  632  in the volume V 28 . In light of the value of the length l 2 , that dead space is relatively small. 
         [0081]    In this configuration, the elastic and sealed bearing of the sleeve  40  around the needle  62  guarantees that the contents of the bottle  110  will not leak into the volume V 40 , below the portion  42 . 
         [0082]    By turning the assembly thus formed over again, it is possible to separate the syringe from the bottle  10 , by exerting an axial pulling force E 4  relative to the base  20 , which extracts the subassembly  60  from the base  20  with the needle  62  mounted on the syringe  210  in the usage configuration. 
         [0083]    This extraction movement causes cleaning of the distal part of the needle  62  by the sleeve  40 , as explained above. 
         [0084]    It will be noted that the device  10  according to the invention is particularly simple and intuitive to use, by exerting only axial forces, except to connect the syringe  210  on the tip  64 , and it comprises three main parts, i.e., the base  20  and the sleeve  40 , which are a single component, and the subassembly  60  made up of two pieces.