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
  • A61J1/2093—Containers having several compartments for products to be mixed
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
  • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
  • B65D25/00—Details of other kinds or types of rigid or semi-rigid containers
  • B65D25/02—Internal fittings
  • B65D25/04—Partitions
  • B65D25/08—Partitions with provisions for removing or destroying, e.g. to facilitate mixing of contents
  • B65D25/085—Partitions with provisions for removing or destroying, e.g. to facilitate mixing of contents the partition being in the form of a plug or the like which is dislodged by means of a plunger rod or the like pushing the plug down
• • 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
  • A61J1/202—Separating means
  • A61J1/2041—Separating means having removable plugs

Definitions

• the subject of the invention is a system which makes it possible to ensure the mixing of two isolated components, in particular a solvent and a lyophilisate, before their removal and then their injection using a syringe, of any type and more precisely, it relates to a mixing bottle with a double pull-out compartment which makes it possible to carry out the mixing by manual action, without having to use the syringe as a means of transfer.
• a product such as the mixture of a solvent and a lyophilisate into the body of a patient is a normal operation which is carried out most of the time using a syringe.
• the products must first be mixed with each other just before injection, and this under optimal conditions of sterility and safety.
• the injection of the product is done from a disposable syringe sold empty in a sterilized packaging, and from a vial or a vial pre-filled with the product to be injected which is aspirated in the syringe before the injection.
• This system is suitable for the injection of simple single-dose product but is not suitable for mixing a solvent and a lyophilisate which should only be brought into contact at the last moment.
• the two components are usually each contained in an independent bottle and their mixing is ensured using a disposable syringe itself which may be made of plastic.
• a disposable syringe itself which may be made of plastic.
• the liquid is drawn from a first bottle using the syringe, then it is transferred to the other bottle which is then shaken to obtain a homogeneous mixture, the needle being able to remain stuck in the stopper during this last operation. . It remains to aspirate the mixture obtained using the syringe before proceeding with the injection. It can therefore be seen that this operating mode requires two bottles and two successive manipulations, thereby increasing the risks of untimely bite.
• the solution which consists in using a syringe pre-filled with one of the components for example the solvent and to have only one bottle for the lyophilisate. This reduces the number of manipulations, but in return it is necessary that the pre-filled syringe is made of a material capable of responding to the constraints related to interactions content-containing, for example glass, more expensive material which excludes the use of a simple standard disposable syringe made from standard or convenience plastics.
• the objective is therefore to have a device which makes it possible to respond to the injection modes usually encountered and as described above, in combination with a safety syringe.
• the main object of the invention is therefore a mixing bottle making it possible to ensure the mixing of two components before their removal, a bottle which has two nesting compartments, one of which consists of the bottle itself and the other of a profiled seal. in the form of a cup capable of moving inside said bottle to bring the two compartments into contact, under the action of a perforable stopper which can be moved in the neck of the bottle against the force of a elastic restraint.
• the neck has a narrower section than that of the main flared body of the bottle, the lower part of which constitutes a compartment for one component and the seal delimiting the other compartment for the other component is maintained. inside said neck to separate one from the other, in a leaktight manner, the two compartments.
• the seal consists of a circular base on which are reported diametrically opposite vertical sides, externally shaped to match the circular outline of the neck of the bottle, openings being formed between the sides.
• the lower part of the stopper is supported on the sides of the seal, the stopper and the seal being joined together, or else the stopper and the seal form a single piece.
• the elastic retaining member is a crimping sleeve covering the head of the stopper, a sleeve whose side walls are in the form of an accordion and whose
• a needle is integrated in the stopper, its tapered end flush with the lower part of the stopper.
• Figure 1 a sectional view of a mixing bottle.
• Figure 2 a schematic perspective view of the seal included in the bottle.
• Figure 3 a schematic sectional view partially showing the attachment of the seal to the plug.
• Figure 4 a sectional view of the bottle according to Figure 1, in the mixing position.
• Figure 5 a schematic perspective view of an alternative embodiment of the seal.
• Figure 6 a sectional view of a bottle with needle integrated in the cap.
• FIG. 7 a partial sectional view on a larger scale of the stopper according to FIG. 6.
• the mixing bottle 1 illustrated in FIG. 1 has a neck 2 of narrower section than that, flared, of the main body which contains the solvent 3, the neck further forming an annular rim 7 on the outside of the bottle.
• This is formed of a circular base 5 whose outer edge forms sealing lips 6.
• On the base 5 are reported two diametrically opposite vertical sides 8 which are profiled externally to conform to the circular outline of the neck.
• the sides and the circular base of the joint 4 form a cup delimiting a compartment which serves as a housing for a pellet 9 of lyophilis t, however leaving openings 12 between the sides 8 for the passage of liquid.
• a cylindrical plug 10 also made of elastomer, the cylindrical part of which slides freely in the neck 2 of the bottle, the seal being also provided for example by lips. 11.
• This stopper closes the bottle 1 ensuring the tightness of the compartment containing the lyophilisate 9.
• this elastomer stopper 10 is hollow to allow the passage of the needle of a syringe during the aspiration phase. of the mixture to be injected.
• the cap is not fully inserted into the neck of the bottle. Its head 13 is capped with a crimping sleeve 14 whose side walls 15 are in the form of an "accordion" and whose lower end is hooked by construction to the annular rim 7 of the bottle.
• a retractable capsule is provided on the top of the crimping sleeve, so as to be able to introduce the needle into the head of the stopper without detaching its crimping which must be maintained during the entire operation.
• the seal 4 and the lower part of the plug 10 are made integral by a connection of the tenon-mortise type known per se, visible in FIG. 3.
• FIG. 1 therefore shows a mixing bottle as obtained in manufacturing, in which the solvent and the lyophilisate are each located in their respective compartment, without the possibility of untimely mixing, whatever the transport and shocks undergone by the bottle, due to the fact that the crimping sleeve 14 strictly maintains the plug in its position, as well as the seal 4 which is associated with it.
• the bottle 1 being kept inverted, the neck 2 being oriented downwards, it is easy to aspirate the dose to be injected using a syringe by pricking the head 13 of the stopper 10 in its middle after removal of the retractable capsule, the needle easily passing through the hollow body of the stopper.
• the plug 10 and the seal 4 are not connected to each other, the seal remaining in place by the simple pressure exerted by the elastomer on the walls of the neck. When the cap is pushed in, the seal falls into the bottom of the bottle and mixing is done automatically.
• the plug and the seal form a single piece whose manufacture by molding is thus simplified.
• the vertical sides 8 of the seal 4 merge with the wall of the plug 10.
• the seal is formed of a circular base on which abuts a ring which delimits the edge of the cup.
• the end of the needle 16 is flush with the base of the stopper 10 and its tapered end is protected from lyophilisate by a protective cup 17 mounted at the center of a cross 18 inserted between said stopper and the seal 4.
• the head 13 of the plug is for this purpose hollowed out of a cell 19 into which the needle 16 opens and in which is arranged a profiled needle holder 20 capable of receiving the end of a syringe, the needle holder being closed at its upper part by a small shutter 21.
• a locking system with clips or notches is provided in the needle holder to avoid disassembly needle-syringe.
• the shutter may be of any other type, for example with a removable tab, etc.

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)
• Engineering & Computer Science (AREA)
• Mechanical Engineering (AREA)
• Medical Preparation Storing Or Oral Administration Devices (AREA)
• Details Of Rigid Or Semi-Rigid Containers (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)

Applications Claiming Priority (3)

Publications (1)

Family

ID=9510439

Family Applications (1)

Country Status (7)

Families Citing this family (12)

Family Cites Families (4)

• 1997
  • 1997-08-22 FR FR9710573A patent/FR2767514B1/fr not_active Expired - Fee Related
• 1998
  • 1998-08-20 CN CN98810062A patent/CN1071242C/zh not_active Expired - Fee Related
  • 1998-08-20 CA CA002301727A patent/CA2301727A1/fr not_active Abandoned
  • 1998-08-20 WO PCT/FR1998/001825 patent/WO1999010245A1/fr not_active Application Discontinuation
  • 1998-08-20 EP EP98942758A patent/EP1005429A1/de not_active Withdrawn
  • 1998-08-20 BR BR9815583A patent/BR9815583A/pt not_active IP Right Cessation
  • 1998-08-20 JP JP2000507588A patent/JP2001514029A/ja not_active Withdrawn

Non-Patent Citations (1)

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