Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
  • A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
  • A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
  • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
  • B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
  • B65B3/003—Filling medical containers such as ampoules, vials, syringes or the like
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
  • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
  • A61J1/2006—Piercing means
  • A61J1/201—Piercing means having one piercing end
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
  • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
  • A61J1/2048—Connecting means
  • A61J1/2055—Connecting means having gripping means
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
  • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
  • A61J1/2048—Connecting means
  • A61J1/2065—Connecting means having aligning and guiding means
• • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
  • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
  • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
  • Y10T29/00—Metal working
  • Y10T29/49—Method of mechanical manufacture
  • Y10T29/49826—Assembling or joining
  • Y10T29/49863—Assembling or joining with prestressing of part
  • Y10T29/4987—Elastic joining of parts

Definitions

• the invention relates to a connection device between a container provided with a neck closed by a pierceable stopper and a container intended to be equipped with a needle, such a container may, for example, be a syringe.
• the invention also relates to a method of assembling such a connection device and to a method of filling a container intended to be equipped with a needle, in which such a connection device is used.
• FR A 2,717,086 provides for connecting a vial to a syringe already equipped with a needle by using a guide piece which comprises a cylindrical body.
• a fastener is part of a proximal end of a cylindrical sheath whose distal end is guided by a sleeve and forms a tip for perforating a workpiece mounted in an end portion of the cylindrical body.
• This distal end is not integral with the sleeve but the fastener, so that the perforation of the cap can be obtained only by the introduction of the syringe with its needle inside the connection device. This material does not allow access to the interior volume of the bottle as the syringe is not in place.
• a portion of elastic material ensures the seal between the end of the syringe and the fastener, without coming into contact with the needle.
• the dead volume of this material extends to the level of the nose of the syringe, which induces significant product losses.
• GB 2 446 778 discloses an adapter which is intended to cooperate with a standard syringe provided with a needle, which is not compatible with the use of a syringe devoid of needle.
• the risks of leakage around the needle of the syringe are important especially when a set of a bottle of an adapter and a needle is disposed in reverse configuration to drain the contents of the bottle in the needle.
• the invention relates to a connection device between a container provided with a neck closed by a pierceable stopper and a container intended to be equipped with a needle, this device comprising a base provided with mounting means on the container. which defines a central bore and on which the container can be mounted.
• a needle belonging to a subassembly engaged in the central bore of the base part of the connection device and intended to be mounted on the container, is disposed in the central bore, according to a direction parallel to a longitudinal axis of this bore, while a sealing sleeve is disposed in the central bore, around the needle and in contact therewith, the base being integral and comprising a perforating member plug extending from an intermediate wall of the base, opposite the central bore, parallel to its central axis and to a distal end, while the perforating member of the The plug is hollow and its internal volume is in communication with the central bore and with a volume radially surrounding the distal end of the perforating member.
• connection device of the invention can take place by means of translational movements, without requiring rotation or complex movement, which is quite intuitive for a user.
• the device of the invention is compact and effectively protects the needle before use.
• the device of the invention is compatible with the use of a syringe devoid of needle since the subset to which the needle belongs is engaged in the central bore of the base.
• the perforating member may be provided to perforate the cap of the container due to the only establishment of this base on the neck of the container.
• the structure of the device of the invention is furthermore simple, which makes it possible to control its cost price and its manufacturing time. According to advantageous but non-mandatory aspects of the invention, such a device may incorporate one or more of the following features, taken in any technically permissible combination:
• the internal volume of the perforating member forms a partial receiving housing of the needle.
• the free end of the part of the needle received in the internal volume of the perforating 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 perforating member.
• the minimum unstressed inner diameter of the sleeve is smaller than the outer diameter of the needle.
• the base and a fixed end of the needle are provided with complementary relief blocking the needle in a translation movement parallel to the longitudinal axis of the bore, in the direction of the perforating member.
• the sleeve is supported, opposite the tip, against the bottom of the bore while, when the tip is blocked against the base by cooperation complementary reliefs, it exerts on the sleeve a force of axial compression and that the sleeve is provided to expand radially under the effect of such a compressive force.
• the sleeve is cylindrical outer shape with a circular base, on one part, and frustoconical shape, on another part.
• the perforating member is provided to perforate the cap of the container due to the sole mounting of the base on the container, without interaction with the container.
• the dead volume of the device extends in the internal volume of the perforating member, in the sleeve to a narrowed area of the sleeve in contact with the needle and around the perforating member.
• the dead volume of the device is less than 25 mm 3 .
• the subassembly is provided with removable hooking means on the container.
• the invention also relates to a method of assembling a device as mentioned above which comprises the steps of:
• the invention relates to a method of filling a container intended to be equipped with a needle with a product contained in a container provided with a neck closed by a pierceable stopper.
• a connection device as mentioned above is used and steps of:
• the mounting means are elastically deformed and are hooked under the neck of the receptacle, keeping the perforating member in a position where it puts the volume in communication with one another. internal of the container and the internal volume of a part of the subassembly in place in the central bore of the base.
• Figure 1 is an exploded perspective view and in axial section, over a quarter of its circumference, a connection device according to the invention
• Figure 2 is an axial section of the device of Figure 1 above a bottle whose neck is closed by a pierceable stopper;
• Figure 3 is a section similar to Figure 2 when the connecting device is mounted on the bottle;
• connection device is an exploded perspective view of the connection device, at another angle and in axial section on its half-circumference;
• Figures 5 to 8 are side views showing steps of a method of assembling the device of Figures 1 to 4 and
• Figures 9 to 13 show steps of a drug reconstitution process, in which a syringe is filled with a product contained in a vial, using the device of Figures 1 to 4.
• connection device 10 shown in Figures 1 to 4 comprises a base 20 monobloc and made of molded synthetic material, for example polycarbonate or ABS.
• This base 20 is provided with an annular portion 21 from which extend four tabs 22 elastically deformable and whose geometry allows their snapping around the outer collar 122 of the neck 120 of a glass vial 1 10.
• the tabs 22 define between them a volume V22 receiving the neck 120 when the device 10 is in place on the bottle 1 10, as shown in Figure 3.
• an inner beak 24 of each tab 22 abuts against a lower flank 134 of a cap 130 which surrounds the flange 122.
• This flank 134 is itself in abutment against a surface 124 of the flange 122 which is directed towards the bottom 1 12 of the flask 10.
• the base 20 is provided with a central bore 26 whose X26 longitudinal axis is noted.
• the axis X26 constitutes a longitudinal and central axis for the base 20.
• Four stiffening ribs 252 are formed outside the tubular portion 25 at the center of which is formed the bore 26.
• the ribs 252 extend between the tubular portion 25 and the annular portion 21.
• 23 is the surface of the portion 21 opposite the ribs 252.
• the surface 23 is perpendicular to the axis X26 and the tabs 22 extend parallel to the axis X26, from a skirt 27 which surrounds this surface.
• the volume V22 extends to the level of the surface 23 and is surrounded, radially with respect to the axis X26, by the skirt 27 in the vicinity of the surface 23.
• the portion of the volume V22 closest to the surface 23 surround the flange 122 and the cap 130 in the mounted configuration of the base 20 on the bottle 1 10.
• the end of the portion 25 opposite the portion 21 is bordered by an outer flange 254.
• the inner spouts 24 of the tabs 22 are each provided with a surface 242 facing away from the bore 26.
• the surfaces 242 are frustoconical and divergent with respect to the axis X26 away from the bore 26. This geometry of the surfaces 242 facilitates the elastic deformation of the tabs 22 during the introduction of the base 20 on the neck 120 of the bottle 1 10, by an axial translation movement.
• a hollow punch 28 extends along the axis X26, in the volume V22 and from the center of the surface 23.
• the punch 28 is intended to perforate a plug 128 of elastomer which closes the neck 120. In this sense the punch 28 constitutes a perforating member of the plug 128.
• the plug 128 is immobilized in the neck 120 thanks to the cap 130 which is made of aluminum or plastic.
• V28 denotes the internal volume of the punch 28, this inner volume being in the form of a bore centered on the axis X26.
• An opening 286 is provided on one side of the punch 28, near the end 282. This opening communicates the volume V28 with the volume V22 which surrounds the end 282, radially with respect to the axis X26.
• the device 10 also comprises a one-piece sealing sleeve 40 made of a synthetic or natural flexible material, such as an elastomer.
• the sleeve 40 is made of injection moldable Santoprene.
• X40 is noted the longitudinal axis of the sleeve 40 and V40 its internal volume which is centered on the axis X40 and symmetrical with respect to this axis.
• the diameter of the volume V40 is variable over the length of the sleeve 40. More specifically, the sleeve 40 comprises a narrowed zone 42 where its internal diameter has a minimum value d40 when the sleeve 40 is not constrained by external forces.
• the outer surface of the sleeve 40 comprises a portion 44 which is cylindrical with a circular cross-section and centered on the axis X40, and a portion 46 which is frustoconical, centered on the axis X40 and convergent towards this axis in a direction away from Portion 44.
• the bore 26 comprises two portions 267 and 268 which are respectively cylindrical and frustoconical and convergent towards 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.
• the device 10 further comprises a subset 60 formed of 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 is waiting for connection with a syringe, as explained below.
• the tip 60 is provided to be mounted reversibly on a syringe. It can be a standard product of the trade, whose cost price is well controlled.
• the needle 62 is metal
• the tip 64 is plastic, for example polypropylene.
• the tip 64 is provided with a flange 642 for attachment to the end of a syringe 210, such as those conventionally used for the reconstitution and injection of drugs.
• the interior volume V64 of the tip 64 is in communication with the central channel 626 of the needle 62.
• the elements 62 and 64 can be secured by any known technique, in particular by overmolding or gluing.
• X60 is a longitudinal axis of the subassembly 60.
• the elements 62 and 64 are aligned and centered on the axis X60.
• the end piece 64 is provided with four fins 644 which extend outwardly from the endpiece 64, radially with respect to the axis X60.
• the surface of the base 20 which defines the bore 26 is provided with reliefs 263 between which are defined slideways 264 for receiving the fins 644 when the endpiece 64 is engaged in the bore 26, as explained herein. -after.
• the cooperation of the fins 644 and slideways 264 provides an antirotation function of the subassembly 60 relative to the base 20 when the endpiece 64 and engaged in the bore 26.
• the end piece 64 is also provided with an outer shoulder 646 which extends between the fins 644 and bears against a surface 266 of each relief 263 which is opposite the bottom 262. The cooperation of the shoulder 646 and the 266 surfaces limits the depression of the tip 64, and therefore the needle 62, in the bore 26, towards the volume V22.
• the axes X26, X40 and X60 are merged 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.
• the shoulder 646 rests on the surfaces 266 and the fins 644 exert on the sleeve 40 a force E1 bearing the sleeve 40 against the bottom 262.
• the bottom 262 then exerts a reaction force E2 on the sleeve 40.
• the sleeve 40 is compressed between the end surface 644A of the fins 644 and the bottom 642.
• This compression of the sleeve 40 has the effect of expanding it radially with respect to the X26 and X40 axes when merged, which firmly portions 44 and 46 of its outer surface against the surface defining the bore 26 inside the base 20, respectively at its portions 267 and 268.
• the seal between the elements 20 and 40 is thus ensured persistent.
• This seal is obtained thanks to the elastically deformable character, radially with respect to the axis X40, of the sleeve 40.
• the needle 62 extends parallel to the axis X26. In practice, it extends along the axis X26 and the distal end 622 of the needle 22 is engaged in the volume V28, without contact with the inner surface of the punch 28. The punch 28 thus mechanically protects this distal end 622 , without risk of pollution.
• the distal end 622 of the needle 62 is shifted along the axes X26 and X60 together, a length fo. relative to the distal end 282 of the punch 28.
• the length fo. is greater than 2 mm, preferably greater than 3 mm, which reduces the dead volume around the needle 62 when the bottle 1 equipped with the device 10 is returned to the position of Figure 12.
• the punch 28 has perforated the plug 128 due to the engagement of the tabs 22 under the flange 122, so that the volume V28 communicates with the internal volume V1 of the vial 10, through the opening 286. Since the distal end 622 of the needle 62 is disposed in this volume V28, the central channel 626 of the needle 62 thus communicates with the volume V1 10, through the volume V28, the opening 286 and the volume V22. Given its one-piece nature with the rest of the base 20 and in particular with the annular portion 21, the punch 28 is caused to perforate the plug 128 simply by mounting the base 20 on the container 10, without interaction with a syringe or other member external to the device 10.
• the device 10 makes it possible to put the channel 626 in communication with the volume V1 10, while protecting the distal end 622 of the needle 62 which is mounted on the base 20, within the device 10, prior to implementation.
• place this device on the bottle D62 denotes the outer diameter of the needle 62, this diameter being constant over the length of the needle.
• the diameter d40 is chosen smaller than the diameter D62. In practice, the difference in these diameters can be between 5% and 25% of the diameter. This ensures an effective sealing between the sleeve 40 and the needle 62, at the zone 42. This also ensures, when removing the subassembly 60 relative to the base 20 as explained below, the friction wiping the outer surface of the needle 62, at its portion received in the volume V28.
• the dead volume of the assembly formed by the device 10 and the bottle 1 10 comprises an interior volume portion V28 of the punch 28 and a portion V'40 of the volume. inside the sleeve 40 which extends between the volume V28 the narrowed area 42 of the sleeve 40 which is in contact with the needle 62.
• This dead volume also comprises a portion V128 of the internal volume of the plug 128 which extends between the bottom of this plug and the opening 286.
• This dead volume is shown in gray in Figure 3. It is substantially less important than in known materials, in particular because it does not extend substantially above the punch 28 since the narrowed zone 42 is close to the lower end of the sleeve 40.
• This dead volume consisting of the volumes V28, V'40 and V128 has a value less than 25 mm 3 , in practice less than 22 mm 3 (cubic millimeters).
• FIGS. 5 to 8 A method of assembling the device 10 is shown in FIGS. 5 to 8.
• a tube 310 secured to a support 320 is used, as well as a plate 330 movable in translation relative to the support 320 and to the tube 310.
• the tube 310 is chosen so that its outer diameter D310 is compatible with its introduction into the sleeve 40, by means of an elastic deformation thereof.
• the inside diameter d310 of the tube 310 is chosen strictly greater than the diameter d62.
• the subassembly 60 is positioned relative to the sleeve 40 by aligning the axis X60 with the central axis X310 of the tube 310, then the needle 62 is engaged in the tube 310, which is possible considering the difference between diameters D62 and d310.
• This operation is represented by the arrow F2 in FIG. 6. It takes place without contact between the sleeve 40 and the needle 62.
• the plate 330 is spaced apart from the support 320, in translation along the axis X310 and the axis X60, as represented by the arrow F3, which has the effect of extracting the tube 310 of the sleeve 40 then in place around the needle 62.
• the elements 60 and 40 are pre-assembled and the distal end 622 of the needle 62 protrudes from the sleeve 40 without having been in direct contact with it, thus without risk of pollution of this end 622 by the material constituting the sleeve 40.
• the base 20 is reported around the elements 60 and 40 pre-assembled, as shown by the arrow F4. During this movement, the X26, X40 and X60 axes are aligned. The distal end 622 of the needle 62 is introduced into the interior volume V28 without contact with the base 20.
• the minimum inside diameter d28 of the punch 28 is greater than the diameter D62.
• the diameter d28 may be between two and four times greater than the diameter D62.
• the device 10 Before use, the device 10, which is compact, can be stored in a blister 400, as shown in FIG. 9.
• the blister 400 is open and the device 10 is mounted on the neck 120 of the bottle 1 10 by placing it on this neck and then exerting a thrust towards the bottom 1 12 in the direction of the arrow F5 in Figure 2.
• This allows the device 10 to pass from the configuration of the FIG. 2 to that of FIGS. 3 and 10, with elastic deformation of the tabs 22. This induces the perforation of the plug 128 by the punch 28.
• a luer or luer-lock type lock can be used. Alternatively, other types of locks may be considered.
• the resilient and tight support of the sleeve 40 around the needle 62 ensures that the contents of the bottle 1 10 do not leak in the volume V40, below the portion 42.
• This extraction movement induces a cleaning of the distal portion of the needle 62 by the sleeve 40, as explained above.
• the device 10 of the invention is particularly simple and intuitive to use, exerting only axial forces, except for the connection of the syringe 210 on the tip 64, and that it comprises three main parts, namely the base 20 and the sleeve 40 which are integral and the subassembly 60 consists of two parts.

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• Health & Medical Sciences (AREA)
• Pharmacology & Pharmacy (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Engineering & Computer Science (AREA)
• Mechanical Engineering (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)
• Medical Preparation Storing Or Oral Administration Devices (AREA)
• Closures For Containers (AREA)

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• 2011
  • 2011-06-06 FR FR1154884A patent/FR2975896B1/fr not_active Expired - Fee Related
• 2012
  • 2012-06-05 US US14/123,116 patent/US8985162B2/en active Active
  • 2012-06-05 PL PL12729060T patent/PL2717827T3/pl unknown
  • 2012-06-05 JP JP2014514035A patent/JP5981535B2/ja active Active
  • 2012-06-05 PT PT127290609T patent/PT2717827E/pt unknown
  • 2012-06-05 BR BR112013031087-1A patent/BR112013031087B1/pt active IP Right Grant
  • 2012-06-05 RU RU2013158253/15A patent/RU2602743C2/ru active
  • 2012-06-05 AU AU2012266433A patent/AU2012266433B2/en active Active
  • 2012-06-05 EP EP12729060.9A patent/EP2717827B1/de active Active
  • 2012-06-05 CN CN201280027935.8A patent/CN103619306B/zh active Active
  • 2012-06-05 WO PCT/EP2012/060591 patent/WO2012168235A1/fr not_active Ceased
  • 2012-06-05 ES ES12729060.9T patent/ES2545631T3/es active Active
  • 2012-06-05 CA CA2837816A patent/CA2837816C/fr active Active

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