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
  • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
  • A61J1/10—Bag-type containers
• • 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
  • A61J1/1475—Inlet or outlet ports
• • 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
  • A61J1/2006—Piercing means
  • A61J1/2013—Piercing means having two piercing ends

Definitions

• the present invention relates to the mixing of one substance with another, in particular in the medical field with a view for example to the reconstitution of a medicament by means of a diluent.
• the invention relates to the device, commonly called reconstitution device, intended to operate such a mixture.
• a diluent which can be for example a dextrose solution, a saline solution or even water.
• these medicinal products must be mixed with a diluent contained in a flexible bag provided for this purpose with injection tubing comprising an end piece made of a material, such as latex for example, capable of being pierced by a needle, the passage formed by the latter closing itself upon withdrawal of the needle.
• a diluent contained in a flexible bag provided for this purpose with injection tubing comprising an end piece made of a material, such as latex for example, capable of being pierced by a needle, the passage formed by the latter closing itself upon withdrawal of the needle.
• the communication between the drug vial and the flexible bag is ensured using a reconstitution device consisting of a hollow needle pointed at its two ends and projecting into two open cylindrical sockets arranged head to tail and shaped to receive, one, the mouth of the vial with its latex stopper for example and, the other, the tip of the injection tubing of the flexible bag.
• a reconstitution device consisting of a hollow needle pointed at its two ends and projecting into two open cylindrical sockets arranged head to tail and shaped to receive, one, the mouth of the vial with its latex stopper for example and, the other, the tip of the injection tubing of the flexible bag.
• the aim of the present invention is to simplify this system and make it more economical by combining a reconstitution device and a flexible pouch as soon as the latter is manufactured by pre-positioning said device, and by packaging the device + pouch assembly in a package. single sterile.
• the subject of the invention is a reconstitution device in particular for mixing substances in the medical field, of the type comprising a hollow needle, pointed at its two ends and fixed on a support defining two coaxial sockets enveloping each end of the needle and responsible for receiving, one, the mouthpiece with a stopper of a vial and, the other, the end piece of an injection tube of a flexible bag, so, by perforation of said stopper and tip, to put the vial and the flexible bag into communication via said needle, characterized in that said socket, on the flexible pocket side, is dimensioned and arranged to engage on the tip in a first stable position in which the device is secured to the pocket without the needle being in contact with the nozzle and in that said sleeve is slidably mounted on the nozzle so as to pass, by a simple depression of the device on the nozzle, said first position in a second, stable position, corresponding to the piercing of the nozzle by the needle.
• the vial face of the device can be conventional and include a conventional socket for the reception of an equally conventional vial.
• the reconstitution device is provided with means for positioning and retaining, at least in the first of the aforementioned positions, the tip socket on the tip of the injection pipe of the flexible bag.
• the invention also relates to the assembly consisting of a flexible bag provided with at least one injection tube with a prepositioned nozzle in said first retaining position in the socket concerned of the reconstitution device.
• the device of the invention therefore has substantial advantages, particularly in terms of ease of management and use.
• Figure 2 illustrates the device of Figure 1 in place in the standby position on the end of an injection tubing of a flexible bag and, - Figure 3 shows the device of Figure 2 in the second position, operational .
• the reconstitution device shown at 1 in FIG. 1 comprises a hollow needle 2 passing through a circular support 3 extended towards each pointed end of the needle, with a cylindrical sleeve.
• One of the sockets (4) is intended to receive (FIGS. 2 and 3) the end piece 5 of an injection pipe 6 of a flexible bag 7.
• the other socket 8 disposed head to tail with respect to the socket 4, has a larger diameter for receiving the mouthpiece provided with a stopper 9 (FIG. 3) of a vial 10 of medication, for example.
• the socket 8 has an internal diameter adapted to the vial 10 and is closed during periods of non-use by a plug B for safety purposes.
• the length of the sleeve 8 is slightly greater than that of the protruding part of the needle 2.
• the sleeve 4 is very substantially longer than the projecting part of the needle 2 in order to receive (FIG. 2) the whole of the end piece 5 in an area at a distance from the pointed end of said needle.
• the internal diameter of the sleeve 4 corresponds to the external diameter of the nozzle 5, the wall of which is made of elastic material.
• the nozzle 5 is of conventional structure made of a material such as latex allowing it to be pierced by the needle 2, the passage hole closing by itself after withdrawal of the needle, as is the material of the plug 9.
• the sleeve 4 is internally provided with a slight annular bead 11, discontinuous as shown or not, however at a distance from this bead 11 corresponding to the length of the nozzle 5 are formed one or several small internal protrusions, for example two diametrically opposite protrusions 12, shaped at the end of two tongues 13 cut in the wall of the socket 4.
• the device 1 is in one piece and produced for example by molding an appropriate plastic material.
• FIG. 2 shows the device 1 pre-positioned on the injection pipe 6, in the standby position.
• the device 1 is in its first stable position, the end piece 5 having been engaged in the socket 4 by force to overcome, thanks to the elasticity of the end piece, the inlet bead 11, the end piece 5 being introduced completely and being stopped in this first position by the two stop projections 12.
• the tip of the needle 2 is kept at a distance from the nozzle 5 and the device 1 is integral with the flexible bag 7.
• the assembly can therefore be handled, packaged in a sterile flexible packaging. , stored and managed as a single object.
• the bag 7 that is to say when one wants to mix the contents of the vial 10, with a dilution liquid for example contained in the bag.
• the device 1 is first placed on the tubing 6 in the position of Figure 2 (standby position). Then, the vial 10 is introduced through its stopper 9 into the socket 8 so as to pierce the stopper. Finally, the device assembly 1-flask 10 is pressed in the direction of the pocket 7 in order to pierce the tip 5 by the needle.
• the two containers 7 and 10 are then in communication via the needle 2 and the tube 6.
• the device of the invention has the advantage of allowing the removal of the device 1-flask 10 assembly from the end piece 5 after the reconstitution operation.
• the operator finds himself facing a pocket 7 in which he can, via the tubing 6, make an additional injection if necessary.
• the separation between the bag 7 and the assembly 1-10 is desirable for an optimized treatment of hospital waste.
• the invention is obviously not limited to the embodiment shown and described above, but on the contrary covers all variants thereof, in particular as regards the means 11, 12 for positioning-blocking the end piece 5 in his first position.
• the socket 8 can optionally be provided internally in the known manner with one or more projections, three for example, as shown at 15 in the figures, for retain elastically in the correct insertion position the stopper 9 of the vial, and externally also in the known manner, of one or more protrusions, three for example, as shown in 16 for retaining the stopper B.

Landscapes

• 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)
• Medical Preparation Storing Or Oral Administration Devices (AREA)
• Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
• Mixers Of The Rotary Stirring Type (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)

Applications Claiming Priority (3)

Publications (2)

Family

ID=8857302

Family Applications (1)

Country Status (7)

Families Citing this family (14)

Family Cites Families (5)

• 2000
  • 2000-12-06 FR FR0015823A patent/FR2817465B1/fr not_active Expired - Fee Related
• 2001
  • 2001-12-06 DE DE2001620475 patent/DE60120475T2/de not_active Expired - Lifetime
  • 2001-12-06 AT AT01999342T patent/ATE328567T1/de not_active IP Right Cessation
  • 2001-12-06 EP EP01999342A patent/EP1345566B1/de not_active Expired - Lifetime
  • 2001-12-06 WO PCT/FR2001/003853 patent/WO2002045649A1/fr active IP Right Grant
  • 2001-12-06 US US10/433,455 patent/US7442189B2/en not_active Expired - Fee Related
  • 2001-12-06 AU AU2002216186A patent/AU2002216186A1/en not_active Abandoned

Non-Patent Citations (1)

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