EP1744717B1 - Syringe for medical interventions and kit for reconstituting extemporaneous substances, comprising said syringe - Google Patents

Syringe for medical interventions and kit for reconstituting extemporaneous substances, comprising said syringe Download PDF

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Publication number
EP1744717B1
EP1744717B1 EP20050763666 EP05763666A EP1744717B1 EP 1744717 B1 EP1744717 B1 EP 1744717B1 EP 20050763666 EP20050763666 EP 20050763666 EP 05763666 A EP05763666 A EP 05763666A EP 1744717 B1 EP1744717 B1 EP 1744717B1
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EP
European Patent Office
Prior art keywords
syringe
syringe body
auxiliary
piston
passage
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EP20050763666
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German (de)
French (fr)
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EP1744717A1 (en
Inventor
Jean-Pascal Delay
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Sedat SAS
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Sedat SAS
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    • 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
    • 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
    • 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
    • A61J1/2017—Piercing means having three or more piercing ends
    • 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
    • A61J1/2037—Separating means having valve 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
    • A61J1/2058—Connecting means having multiple connecting 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
    • A61J1/2048—Connecting means
    • A61J1/2058—Connecting means having multiple connecting ports
    • A61J1/2062—Connecting means having multiple connecting ports with directional valves
    • 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
    • A61J1/2068—Venting means
    • A61J1/2072—Venting means for internal venting
    • 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
    • A61J1/2068—Venting means
    • A61J1/2075—Venting means for external venting

Definitions

  • the present invention relates to a syringe and a kit for reconstitution of extemporaneous substances comprising such a syringe, as known from the document US 5,643,218 .
  • a syringe In the medical field, it is known to use a syringe to ensure the reconstitution of an extemporaneous mixture consisting of a solvent and a cytotoxic active ingredient.
  • the active ingredient is for example used for the chemotherapy treatment of patients with cancer.
  • the solvent is commonly initially contained in an infusion bag, while the cytotoxic active ingredient, usually in powder form, is initially contained in a vial.
  • the practitioner takes solvent from the bag to introduce it into the body of a syringe.
  • the solvent thus taken is introduced into the flask where it mixes with the powder constituting the active ingredient.
  • the mixture thus reconstituted is re-aspirated into the syringe before being transferred back into the infusion bag.
  • the latter is then placed on an infusion line to progressively administer its contents to the patient.
  • the object of the invention is therefore to propose a syringe that avoids such gaseous releases that may be harmful for medical personnel.
  • the invention relates to a syringe of the aforementioned type, characterized in that the syringe body delimits a closed space in which the piston is movably mounted, which piston defines in this enclosed space, in addition to the chamber of confinement of the fluid, an auxiliary return chamber, the syringe body delimiting a return passage opening in said auxiliary return chamber, and said return passage is extended by an auxiliary connecting member to said complementary volume.
  • the invention also relates to a reconstitution kit comprising a syringe as defined above and a complementary volume adapted for simultaneous connection to the confinement chamber and to the auxiliary return chamber respectively through the main organ of fluidic connection and the auxiliary connection member.
  • the reconstitution kit 10 illustrated on the figure 1 is intended in particular for the extemporaneous preparation of a cytotoxic or other drug for the treatment by cancer chemotherapy or other.
  • This kit essentially comprises a syringe 12 and a bottle 13 initially comprising an active ingredient in powder form.
  • This bottle 13 is formed, for example and as illustrated on the figure 4 , a body 14 of non-deformable glass closed by a lid 15, this body delimiting a closed space. It is initially filled with an active ingredient powder or liquid.
  • the syringe 12 is able to be connected, on the one hand, to the bottle 13 and, on the other hand, to an infusion bag 16.
  • the syringe 12 comprises a syringe body 18 carrying graduations 19 and a three-way dispenser 20 for selectively connecting a chamber of the syringe body selectively to the vial 12 or to the infusion bag 16.
  • the syringe body 18 has a cylindrical wall 22 of generally circular section closed, at a front end, by a transverse wall 24 delimited by a base 26 of the distributor 20. This wall 24 is pierced with a passage 28 for circulation of a fluid entering or leaving the syringe.
  • the passage 28 is extended by a conduit 30 forming a first channel of the distributor 20.
  • the cylindrical wall 22 is closed by a transverse wall 31 pierced at its center with an orifice 32 for the circulation of a piston rod 34.
  • the piston rod 34 is disposed along the axis of the syringe body and has, at its end received in the syringe body, a piston 36 movable axially from one end to the other of the syringe body and having a peripheral lip 38 sealing along the wall. At its end protruding from the syringe body, the piston rod 34 has a transverse bearing surface 38.
  • An O-ring seal 40 is disposed against the transverse wall 31 at the periphery of the piston rod 34. seal is compressed by a support washer 42.
  • the piston 36 defines in the syringe body, at the front, a chamber 44 for confining the fluid. This chamber is generally closed and is open only through the circulation passage 28. On the other side of the piston 36 is defined an auxiliary chamber 46 for booster excess gas.
  • the chambers 44 and 46 are complementary and together form an enclosed space delimited by the syringe body 18.
  • the auxiliary return chamber 46 is closed and opens only by a passage 48 for returning a gaseous excess. This passage is extended by an auxiliary member 50 for connection to the bottle 13.
  • the auxiliary connection member 50 is formed of a metal tube or of reduced section plastic material, for example of 0.5 mm internal diameter. This comprises a main rectilinear section 50A and two end sections 50B, 50C angled extend generally perpendicular to the main straight section 50A.
  • the rectilinear section 50A has a length very slightly greater than the length of the syringe body 18.
  • the rear bent end 50B is engaged in the return passage 48.
  • the rectilinear main section 50A extends along the length of the cylindrical wall 22.
  • the syringe body has, on its outer surface, a channel 52 delimited by two longitudinal lips 54 visible on the figure 1 .
  • the curved end before 50C is tapered at its end denoted 50D, so that the auxiliary member 50 of connection constitutes a hollow needle.
  • the tapered end 50D is adapted to engage through the perforable lid 15 closing the neck of the bottle 13.
  • the base 26 of the distributor 20 is formed for example of injected plastic.
  • the wall 24 forming the end of the syringe body is lined externally with a flange 60 allowing the cylindrical wall 22 to be secured. This joining is effected in an indissociable manner, for example by gluing or ultrasonic welding, so that the distributor can not be dissociated from the syringe body 18.
  • the base 26 defines a cylindrical seat 62 in which is received a slide valve 64 of the dispenser.
  • This bushel passes through the base from one side to the other and is equipped at each end with an actuator 66,68.
  • two other ducts of the distributor open on the seat 62.
  • the three ducts of the dispenser extend in the same plane and are angularly offset by 90 °, as shown in FIG. figure 2 .
  • a conduit 70 connecting the bottle 13 forms a second channel of the dispenser. It comprises a hollow needle 72 projecting from the base 26.
  • the needle 72 extends parallel to the elbow 50C and is intended, like him, to enter the bottle 13 through the pierceable lid 15.
  • the Beveled ends of the needles 50 and 72 are arranged in the vicinity of each other and are preferably spaced apart by less than 1 cm and preferably from 1 to 3 mm.
  • the base 26 has a collar 74 surrounding the projecting end of the needle 72. This collar defines a receiving space of the neck of the bottle 13 and has profiles 76 of elastic engagement behind the neck to ensure a mechanical connection of the bottle and dispenser.
  • the bent section 50C extends in the space delimited by the flange 74, the section 50C and the needle 72 extending parallel to each other for a perforation of the cover 15.
  • the third channel of the dispenser comprises a conduit 80 for transfer to the infusion bag 16.
  • This conduit is provided with a hollow needle 82 projecting from the base 26, in a generally cylindrical socket 84 formed in the base and adapted to receive a nose 86 of the infusion bag 16.
  • this nose 86 is generally cylindrical and is perforable to allow access to the pocket by an access conduit 88.
  • the protruding end of the needle 82 is covered over its entire length by a perforable elastic cap 90 in the form of bellows able to compress axially along the needle 82.
  • the plug 64 is rotatably mounted about its axis, the latter extending perpendicular to the plane in which the ducts 30, 70 and 80 extend.
  • a peripheral groove 92 is provided on the plug 64 to allow the selective connection of the ducts. This groove extends over 180 °.
  • the plug is adapted to, in a first so-called transfer position, ensure the connection of the ducts 30 and 80, the duct 70 being closed and, in a second so-called preparation position, ensure the connection of the ducts 30 and 70, the led 80 being closed.
  • the reconstitution kit is used as follows.
  • the bag 16 and the bottle 13 are not connected to the syringe 12, as shown in FIG. figure 2 .
  • the syringe is stored in sterile packaging.
  • the syringe 12 is first connected to the pocket 16 from the needle 82.
  • the nose 86 of the pocket is engaged in the base 84, so that the cap 90 is perforated. by the needle 82 and retracts along this needle.
  • the beveled end of the needle 82 pierces the nose of the pocket and thus comes into contact with the solvent contained therein, as illustrated in FIG. figure 3 .
  • the piston 36 With the nozzle of the dispenser in its transfer position and connecting the conduits 30 and 80, the piston 36, initially pressed against the front wall 24, is pulled backwards. Under the action of the displacement of the piston 36, the solvent is progressively extracted from the pocket and is received in the confinement chamber 44, as shown in FIG. figure 3 .
  • the air contained in the auxiliary chamber 46 is gradually evacuated through the auxiliary connection member 50. The air is released into the atmosphere, without consequence, this air being sterile.
  • the bottle 13 After filling the chamber 44 with a satisfactory amount of solvent, the bottle 13 is connected. For this purpose, the neck of the bottle is introduced into the space delimited by the flange 74. The cover 15 is then perforated by both the needle 72 and the needle 50.
  • the plug 64 is then rotated 90 ° to be brought into its preparation position, so that the conduits 30 and 70 are connected to each other, the conduit 80 being isolated.
  • the confinement chamber 44 is connected to the bottle 13 through the needle 72, while the auxiliary return chamber 46 is also connected to the bottle 13 by the auxiliary connecting member formed of the needle 50.
  • the bottle is placed with its neck pointing upwards and, as shown in figure 4 the piston is then pushed forward, leading to the expulsion of the solvent into the vial through, successively, ducts 30 and 70. Simultaneously, the excess gas contained in the vial 13 is sucked into the auxiliary booster chamber 46 through the needle 50. The excess gas contained in the bottle is transferred to the booster chamber under the combined action of the emerging pressure in the bottle 13 and under the action of the suction of the auxiliary chamber 46, due to the displacement of the piston 36.
  • the bottle 13 is then inverted, so that the free end of the needle 72 is in contact with the mixture, as illustrated in FIG. figure 5 .
  • the piston 36 is then moved towards the rear of the syringe body by traction on the rod 34, as illustrated on the figure 5 .
  • the mixture is thus re-sucked into the confinement chamber 44 through, successively, conduits 70 and 30.
  • the gas previously sucked into the auxiliary return chamber 46 is reintroduced into the bottle 13 to occupy the free space left by the mixture discharged to the confinement chamber 44.
  • the plug 64 is then returned to its transfer position, providing the connection between the ducts 30 and 80.
  • the mixture contained in the confinement chamber 44 is then reintroduced to the pocket 16 through, successively, conduits 30 and 80 under the action of the piston 36 pushed axially towards the front of the syringe body.
  • the bottle 13 remains connected and gas extracted from the bottle is sucked into the return chamber.
  • a slight depression is created in the bottle 13.
  • the pocket 16 is separated from the syringe by disengaging the nose 86 from the base 84. action of the elasticity of the cap 90, it then relaxes along the needle 82 to completely cover the end thereof. Thus, the mixture still contained in the needle is confined within the cap 90, avoiding any transfer of mixture in liquid and gaseous form to the outside.

Abstract

The syringe (12) comprises a syringe body (18) with a passage (28) for the circulation of fluid defined therein, said circulatory passage (28) being extended by a main element (20) for fluidic connection to a complimentary volume (13), and a moveable piston (36) inside the body of the syringe (18) defining, with the aid of said syringe body (18), a chamber for the containment of fluid, opening out of said circulatory passage (28). The body of the syringe (18) defines a closed space in which the piston (36) is moveably mounted. The piston (36) also defines an auxiliary return chamber inside said closed space. The body of the syringe (18) defines a return passage (48) opening out into the auxiliary return chamber (46). The return passage (48) is extended by an auxiliary element (50) for connection to said complementary volume (13).

Description

La présente invention concerne une seringue et un nécessaire de reconstitution de substances extemporanées comportant une telle seringue, comme connue par le document US 5 643 218 .The present invention relates to a syringe and a kit for reconstitution of extemporaneous substances comprising such a syringe, as known from the document US 5,643,218 .

Notamment, l'invention concerne une seringue, du type comportant :

  • un corps de seringue dans lequel est délimité un passage de circulation d'un fluide, ce passage de circulation étant prolongé par un organe principal de connexion fluidique à un volume complémentaire, et
  • un piston mobile dans le corps de seringue délimitant, avec le corps de seringue, une chambre de confinement du fluide, laquelle chambre de confinement s'ouvre par ledit passage de circulation.
In particular, the invention relates to a syringe, of the type comprising:
  • a syringe body in which is delimited a circulation passage of a fluid, this circulation passage being extended by a main fluidic connection member to a complementary volume, and
  • a piston movable in the syringe body delimiting, with the syringe body, a fluid confinement chamber, which containment chamber opens by said circulation passage.

Dans le domaine médical, il est connu d'utiliser une seringue pour assurer la reconstitution d'un mélange extemporané constitué d'un solvant et d'un principe actif cytotoxique. Le principe actif est par exemple utilisé pour le traitement par chimiothérapie de patients atteints d'un cancer.In the medical field, it is known to use a syringe to ensure the reconstitution of an extemporaneous mixture consisting of a solvent and a cytotoxic active ingredient. The active ingredient is for example used for the chemotherapy treatment of patients with cancer.

Comme connu en soi, le solvant est couramment contenu initialement dans une poche à perfusion, alors que le principe actif cytotoxique, généralement sous forme de poudre, est initialement contenu dans un flacon. Pour la préparation du mélange extemporané, le praticien prélève du solvant de la poche pour introduire celui-ci dans le corps d'une seringue. Le solvant ainsi prélevé est introduit dans le flacon où il se mélange à la poudre constituant le principe actif. Le mélange ainsi reconstitué est ré-aspiré dans la seringue, avant d'être retransféré à nouveau dans la poche à perfusion. Cette dernière est ensuite placée sur une ligne de perfusion pour progressivement administrer son contenu au patient.As known per se, the solvent is commonly initially contained in an infusion bag, while the cytotoxic active ingredient, usually in powder form, is initially contained in a vial. For the preparation of the extemporaneous mixture, the practitioner takes solvent from the bag to introduce it into the body of a syringe. The solvent thus taken is introduced into the flask where it mixes with the powder constituting the active ingredient. The mixture thus reconstituted is re-aspirated into the syringe before being transferred back into the infusion bag. The latter is then placed on an infusion line to progressively administer its contents to the patient.

Lors des transferts successifs, les excès d'air contenus dans le flacon, lors de l'introduction du solvant, sont évacués dans l'atmosphère par un évent prévu à cet effet. Les vapeurs de solvant, et surtout les émanations gazeuses résultant du principe actif s'échappent au travers de cet évent. Celles-ci peuvent être dangereuses pour le personnel médical effectuant ce transfert. Ainsi, il est connu d'équiper l'évent d'un filtre ayant des ouvertures de 0,2 µm afin de retenir, dans le flacon, les molécules nocives.During successive transfers, the excess air contained in the bottle, during the introduction of the solvent, are discharged into the atmosphere through a vent provided for this purpose. The solvent vapors, and especially the gaseous fumes resulting from the active ingredient, escape through this vent. These can be dangerous for the medical staff performing this transfer. Thus, it is known to equip the vent with a filter having openings of 0.2 microns in order to retain the harmful molecules in the bottle.

Toutefois, l'efficacité réelle d'un tel filtre est discutée et la mise en oeuvre de ce filtre est délicate et coûteuse.However, the actual efficiency of such a filter is discussed and the implementation of this filter is delicate and expensive.

L'invention a donc pour but de proposer une seringue évitant de tels dégagements gazeux pouvant être nocifs pour le personnel médical.The object of the invention is therefore to propose a syringe that avoids such gaseous releases that may be harmful for medical personnel.

A cet effet, l'invention a pour objet une seringue du type précité, caractérisée en ce que le corps de seringue délimite un espace clos dans lequel le piston est monté mobile, lequel piston délimite dans cet espace clos, en plus de la chambre de confinement du fluide, une chambre auxiliaire de rappel, le corps de seringue délimitant un passage de rappel s'ouvrant dans ladite chambre auxiliaire de rappel, et que ledit passage de rappel est prolongé par un organe auxiliaire de connexion audit volume complémentaire.For this purpose, the invention relates to a syringe of the aforementioned type, characterized in that the syringe body delimits a closed space in which the piston is movably mounted, which piston defines in this enclosed space, in addition to the chamber of confinement of the fluid, an auxiliary return chamber, the syringe body delimiting a return passage opening in said auxiliary return chamber, and said return passage is extended by an auxiliary connecting member to said complementary volume.

Suivant des modes particuliers de réalisation, la seringue comporte l'une ou plusieurs des caractéristiques suivantes :

  • ledit organe auxiliaire de connexion comprend une aiguille creuse ;
  • elle comporte une tige d'actionnement du piston liée au piston et faisant saillie hors du corps de seringue depuis une extrémité arrière, ledit passage de circulation étant formé à l'extrémité avant du corps de seringue, et ledit passage de rappel est formé au voisinage de l'extrémité arrière du corps de seringue et l'organe auxiliaire de connexion s'étend suivant la longueur du corps de seringue du passage de rappel au voisinage de l'extrémité avant ;
  • l'organe principal de connexion fluidique comporte un distributeur comprenant une embase délimitant au moins trois voies de circulation et un obturateur mobile par rapport à l'embase, une première voie étant reliée audit passage de circulation, une seconde voie comportant un conduit de liaison audit volume complémentaire et une troisième voie comportant un conduit de transfert, ledit obturateur étant mobile entre une position de transfert dans laquelle les première et troisième voies sont reliées et une position de préparation dans laquelle les première et seconde voies sont reliées.
  • le corps de seringue et le distributeur sont indissociables ;
  • le conduit de transfert comporte une aiguille creuse ; et
  • ladite aiguille creuse du conduit de transfert comporte un capuchon perforable et élastiquement déformable recouvrant l'aiguille creuse ;
  • le conduit de liaison comporte une aiguille creuse ;
  • les tronçons d'extrémités libres des aiguilles creuses de l'organe auxiliaire de connexion et du conduit de liaison sont distants de moins de 1 cm.
According to particular embodiments, the syringe comprises one or more of the following characteristics:
  • said auxiliary connecting member comprises a hollow needle;
  • it comprises an actuating rod of the piston connected to the piston and projecting out of the syringe body from a rear end, said circulation passage being formed at the front end of the syringe body, and said return passage is formed in the vicinity the rear end of the syringe body and the auxiliary connecting member extends along the length of the syringe body of the return passage in the vicinity of the front end;
  • the main fluidic connection member comprises a distributor comprising a base defining at least three circulation lanes and a shutter movable relative to the base, a first lane being connected to said circulation passage, a second lane comprising a connection duct to said complementary volume and a third channel comprising a transfer conduit, said shutter being movable between a transfer position in which the first and third channels are connected and a preparation position in which the first and second channels are connected.
  • the syringe body and the dispenser are indissociable;
  • the transfer duct comprises a hollow needle; and
  • said hollow needle of the transfer conduit comprises a perforable and elastically deformable cap covering the hollow needle;
  • the connecting pipe comprises a hollow needle;
  • the free end sections of the hollow needles of the auxiliary connection member and the connecting conduit are less than 1 cm apart.

L'invention a également pour objet un nécessaire de reconstitution comportant une seringue telle que définie ci-dessus et un volume complémentaire adapté pour une connexion simultanée à la chambre de confinement et à la chambre auxiliaire de rappel respectivement au travers de l'organe principal de connexion fluidique et l'organe auxiliaire de connexion.The invention also relates to a reconstitution kit comprising a syringe as defined above and a complementary volume adapted for simultaneous connection to the confinement chamber and to the auxiliary return chamber respectively through the main organ of fluidic connection and the auxiliary connection member.

L'invention sera mieux comprise à la lecture de la description qui va suivre, donnée uniquement à titre d'exemple et faite en se référant aux dessins, sur lesquels :

  • la figure 1 est une vue en perspective éclatée d'un nécessaire de reconstitution comportant une seringue selon l'invention ; et
  • les figures 2 à 6 sont des vues en coupe longitudinale du nécessaire à des stades successifs d'utilisation.
The invention will be better understood on reading the description which follows, given solely by way of example and with reference to the drawings, in which:
  • the figure 1 is an exploded perspective view of a reconstitution kit comprising a syringe according to the invention; and
  • the Figures 2 to 6 are views in longitudinal section of the necessary at successive stages of use.

Le nécessaire 10 de reconstitution illustré sur la figure 1 est destiné notamment à la préparation extemporanée d'un médicament cytotoxique ou autre pour le traitement par chimiothérapie de cancers ou autre.The reconstitution kit 10 illustrated on the figure 1 is intended in particular for the extemporaneous preparation of a cytotoxic or other drug for the treatment by cancer chemotherapy or other.

Ce nécessaire comporte essentiellement une seringue 12 et un flacon 13 comportant initialement un principe actif sous forme de poudre. Ce flacon 13 est formé, par exemple et comme illustré sur la figure 4, d'un corps 14 en verre non déformable obturé par un opercule 15, ce corps délimitant un espace clos. Il est empli initialement d'un principe actif en poudre ou liquide. La seringue 12 est propre à être connectée, d'une part, au flacon 13 et, d'autre part, à une poche à perfusion 16.This kit essentially comprises a syringe 12 and a bottle 13 initially comprising an active ingredient in powder form. This bottle 13 is formed, for example and as illustrated on the figure 4 , a body 14 of non-deformable glass closed by a lid 15, this body delimiting a closed space. It is initially filled with an active ingredient powder or liquid. The syringe 12 is able to be connected, on the one hand, to the bottle 13 and, on the other hand, to an infusion bag 16.

Plus précisément, la seringue 12 comporte un corps de seringue 18 portant des graduations 19 et un distributeur trois voies 20 permettant la liaison sélective d'une chambre du corps de seringue sélectivement au flacon 12 ou à la poche à perfusion 16.More specifically, the syringe 12 comprises a syringe body 18 carrying graduations 19 and a three-way dispenser 20 for selectively connecting a chamber of the syringe body selectively to the vial 12 or to the infusion bag 16.

Comme illustré sur les figures 2 à 6, le corps de seringue 18 comporte une paroi cylindrique 22 de section généralement circulaire obturée, à une extrémité avant, par une paroi transversale 24 délimitée par une embase 26 du distributeur 20. Cette paroi 24 est percée d'un passage 28 de circulation d'un fluide entrant ou sortant de la seringue.As illustrated on Figures 2 to 6 , the syringe body 18 has a cylindrical wall 22 of generally circular section closed, at a front end, by a transverse wall 24 delimited by a base 26 of the distributor 20. This wall 24 is pierced with a passage 28 for circulation of a fluid entering or leaving the syringe.

Le passage 28 est prolongé par un conduit 30 formant une première voie du distributeur 20. A l'extrémité arrière du corps de seringue 18, la paroi cylindrique 22 est obturée par une paroi transversale 31 percée en son centre d'un orifice 32 pour la circulation d'une tige de piston 34.The passage 28 is extended by a conduit 30 forming a first channel of the distributor 20. At the rear end of the syringe body 18, the cylindrical wall 22 is closed by a transverse wall 31 pierced at its center with an orifice 32 for the circulation of a piston rod 34.

La tige de piston 34 est disposée suivant l'axe du corps de seringue et présente, à son extrémité reçue dans le corps de seringue, un piston 36 déplaçable axialement d'une extrémité à l'autre du corps de seringue et présentant une lèvre périphérique 38 assurant l'étanchéité le long de la paroi. A son extrémité faisant saillie hors du corps de seringue, la tige de piston 34 présente une surface d'appui transversale 38. Un joint torique d'étanchéité 40 est disposé contre la paroi transversale 31 à la périphérie de la tige de piston 34. Ce joint est comprimé par une rondelle d'appui 42.The piston rod 34 is disposed along the axis of the syringe body and has, at its end received in the syringe body, a piston 36 movable axially from one end to the other of the syringe body and having a peripheral lip 38 sealing along the wall. At its end protruding from the syringe body, the piston rod 34 has a transverse bearing surface 38. An O-ring seal 40 is disposed against the transverse wall 31 at the periphery of the piston rod 34. seal is compressed by a support washer 42.

Ainsi, le piston 36 délimite dans le corps de seringue, à l'avant, une chambre 44 de confinement du fluide. Cette chambre est généralement close et n'est ouverte que par l'intermédiaire du passage de circulation 28. De l'autre côté du piston 36 est délimitée une chambre auxiliaire 46 de rappel d'excès gazeux. Les chambres 44 et 46 sont complémentaires et forment ensemble un espace clos délimité par le corps de seringue 18.Thus, the piston 36 defines in the syringe body, at the front, a chamber 44 for confining the fluid. This chamber is generally closed and is open only through the circulation passage 28. On the other side of the piston 36 is defined an auxiliary chamber 46 for booster excess gas. The chambers 44 and 46 are complementary and together form an enclosed space delimited by the syringe body 18.

La chambre auxiliaire de rappel 46 est close et s'ouvre seulement par un passage 48 de rappel d'un excès gazeux. Ce passage est prolongé par un organe auxiliaire 50 de connexion au flacon 13.The auxiliary return chamber 46 is closed and opens only by a passage 48 for returning a gaseous excess. This passage is extended by an auxiliary member 50 for connection to the bottle 13.

L'organe auxiliaire de connexion 50 est formé d'un tube métallique ou en matière plastique de section réduite, par exemple de 0,5 mm de diamètre intérieur. Celui-ci comporte un tronçon rectiligne principal 50A et deux tronçons d'extrémité 50B, 50C coudés s'étendent généralement perpendiculairement au tronçon rectiligne principal 50A.The auxiliary connection member 50 is formed of a metal tube or of reduced section plastic material, for example of 0.5 mm internal diameter. This comprises a main rectilinear section 50A and two end sections 50B, 50C angled extend generally perpendicular to the main straight section 50A.

Le tronçon rectiligne 50A a une longueur très légèrement supérieure à la longueur du corps de seringue 18. L'extrémité coudée arrière 50B est engagée dans le passage de rappel 48.The rectilinear section 50A has a length very slightly greater than the length of the syringe body 18. The rear bent end 50B is engaged in the return passage 48.

Le tronçon principal rectiligne 50A s'étend suivant la longueur de la paroi cylindrique 22. Pour le maintien du tube 50, le corps de seringue présente, sur sa surface extérieure, un canal 52 délimité par deux lèvres longitudinales 54 visibles sur la figure 1.The rectilinear main section 50A extends along the length of the cylindrical wall 22. For holding the tube 50, the syringe body has, on its outer surface, a channel 52 delimited by two longitudinal lips 54 visible on the figure 1 .

L'extrémité courbe avant 50C est biseautée à son extrémité notée 50D, de sorte que l'organe auxiliaire 50 de connexion constitue une aiguille creuse. L'extrémité biseautée 50D est propre à s'engager au travers de l'opercule perforable 15 obturant le goulot du flacon 13.The curved end before 50C is tapered at its end denoted 50D, so that the auxiliary member 50 of connection constitutes a hollow needle. The tapered end 50D is adapted to engage through the perforable lid 15 closing the neck of the bottle 13.

L'embase 26 du distributeur 20 est formée par exemple en plastique injectée.The base 26 of the distributor 20 is formed for example of injected plastic.

La paroi 24 formant l'extrémité du corps de seringue est bordée extérieurement d'une collerette 60 permettant la solidarisation de la paroi cylindrique 22. Cette solidarisation est effectuée de manière indissociable, par exemple par collage ou soudage à ultrasons, de sorte que le distributeur ne puisse être dissocié du corps de seringue 18.The wall 24 forming the end of the syringe body is lined externally with a flange 60 allowing the cylindrical wall 22 to be secured. This joining is effected in an indissociable manner, for example by gluing or ultrasonic welding, so that the distributor can not be dissociated from the syringe body 18.

L'embase 26 délimite un siège cylindrique 62 dans lequel est reçu un boisseau coulissant 64 du distributeur. Ce boisseau traverse l'embase de part en part et est équipé, à chaque extrémité, d'un organe de manoeuvre 66,68.The base 26 defines a cylindrical seat 62 in which is received a slide valve 64 of the dispenser. This bushel passes through the base from one side to the other and is equipped at each end with an actuator 66,68.

Outre le conduit 30, deux autres conduits du distributeur débouchent sur le siège 62. Les trois conduits du distributeur s'étendent dans un même plan et sont décalés angulairement de 90°, comme illustré sur la figure 2.In addition to the duct 30, two other ducts of the distributor open on the seat 62. The three ducts of the dispenser extend in the same plane and are angularly offset by 90 °, as shown in FIG. figure 2 .

Un conduit 70 de liaison au flacon 13 forme une deuxième voie du distributeur. Il comporte une aiguille creuse 72 faisant saillie hors de l'embase 26. L'aiguille 72 s'étend parallèlement au tronçon coudé 50C et est destinée, comme lui, à pénétrer dans le flacon 13 au travers de l'opercule perforable 15. Les extrémités biseautés des aiguilles 50 et 72 sont disposées au voisinage l'une de l'autre et sont, de préférence, écartées de moins de 1 cm et de préférence de 1 à 3 mm.A conduit 70 connecting the bottle 13 forms a second channel of the dispenser. It comprises a hollow needle 72 projecting from the base 26. The needle 72 extends parallel to the elbow 50C and is intended, like him, to enter the bottle 13 through the pierceable lid 15. The Beveled ends of the needles 50 and 72 are arranged in the vicinity of each other and are preferably spaced apart by less than 1 cm and preferably from 1 to 3 mm.

L'embase 26 présente une collerette 74 entourant l'extrémité saillante de l'aiguille 72. Cette collerette délimite un espace de réception du goulot du flacon 13 et comporte des profils 76 d'enclenchement élastique en arrière du goulot pour assurer une liaison mécanique du flacon et du distributeur.The base 26 has a collar 74 surrounding the projecting end of the needle 72. This collar defines a receiving space of the neck of the bottle 13 and has profiles 76 of elastic engagement behind the neck to ensure a mechanical connection of the bottle and dispenser.

Le tronçon coudé 50C s'étend dans l'espace délimité par la collerette 74, le tronçon 50C et l'aiguille 72 s'étendant parallèlement l'un à l'autre pour une perforation de l'opercule 15.The bent section 50C extends in the space delimited by the flange 74, the section 50C and the needle 72 extending parallel to each other for a perforation of the cover 15.

La troisième voie du distributeur comporte un conduit 80 de transfert vers la poche à perfusion 16. Ce conduit est muni d'une aiguille creuse 82 faisant saillie par rapport à l'embase 26, dans un culot 84 généralement cylindrique ménagé dans l'embase et propre à recevoir un nez 86 de la poche à perfusion 16.The third channel of the dispenser comprises a conduit 80 for transfer to the infusion bag 16. This conduit is provided with a hollow needle 82 projecting from the base 26, in a generally cylindrical socket 84 formed in the base and adapted to receive a nose 86 of the infusion bag 16.

Comme connu en soi, ce nez 86 est généralement cylindrique et est perforable pour permettre l'accès à la poche par un conduit d'accès 88.As known per se, this nose 86 is generally cylindrical and is perforable to allow access to the pocket by an access conduit 88.

L'extrémité saillante de l'aiguille 82 est recouverte sur toute sa longueur par un capuchon élastique perforable 90 en forme de soufflet propre à se comprimer axialement le long de l'aiguille 82.The protruding end of the needle 82 is covered over its entire length by a perforable elastic cap 90 in the form of bellows able to compress axially along the needle 82.

Le boisseau 64 est monté rotatif autour de son axe, ce dernier s'étendant perpendiculairement au plan dans lequel s'étendent les conduits 30, 70 et 80.The plug 64 is rotatably mounted about its axis, the latter extending perpendicular to the plane in which the ducts 30, 70 and 80 extend.

Une rainure périphérique 92 est ménagée sur le boisseau 64 pour permettre la connexion sélective des conduits. Cette rainure s'étend sur 180°. Ainsi, le boisseau est adapté pour, dans une première position dite de transfert, assurer la connexion des conduits 30 et 80, le conduit 70 étant obturé et, dans une seconde position dite de préparation, assurer la connexion des conduits 30 et 70, le conduit 80 étant obturé.A peripheral groove 92 is provided on the plug 64 to allow the selective connection of the ducts. This groove extends over 180 °. Thus, the plug is adapted to, in a first so-called transfer position, ensure the connection of the ducts 30 and 80, the duct 70 being closed and, in a second so-called preparation position, ensure the connection of the ducts 30 and 70, the led 80 being closed.

Le nécessaire de reconstitution s'utilise de la manière suivante.The reconstitution kit is used as follows.

Initialement, la poche 16 et le flacon 13 ne sont pas liés à la seringue 12, comme illustré sur la figure 2. La seringue est stockée dans un emballage stérile.Initially, the bag 16 and the bottle 13 are not connected to the syringe 12, as shown in FIG. figure 2 . The syringe is stored in sterile packaging.

Après sortie de l'emballage, la seringue 12 est d'abord connectée à la poche 16 depuis l'aiguille 82. A cet effet, le nez 86 de la poche est engagé dans le culot 84, de sorte que le capuchon 90 est perforé par l'aiguille 82 et se rétracte le long de cette aiguille. L'extrémité biseautée de l'aiguille 82 perce le nez de la poche et entre ainsi en contact avec le solvant contenu dans celle-ci, comme illustré sur la figure 3.After leaving the package, the syringe 12 is first connected to the pocket 16 from the needle 82. For this purpose, the nose 86 of the pocket is engaged in the base 84, so that the cap 90 is perforated. by the needle 82 and retracts along this needle. The beveled end of the needle 82 pierces the nose of the pocket and thus comes into contact with the solvent contained therein, as illustrated in FIG. figure 3 .

Le boisseau du distributeur étant dans sa position de transfert et reliant les conduits 30 et 80, le piston 36, initialement plaqué contre la paroi avant 24, est tiré vers l'arrière. Sous l'action du déplacement du piston 36, du solvant est progressivement extrait de la poche et est reçu dans la chambre de confinement 44, comme illustré sur la figure 3. L'air contenu dans la chambre auxiliaire 46 est évacué progressivement au travers de l'organe auxiliaire de connexion 50. L'air est rejeté dans l'atmosphère, sans conséquence, cet air étant stérile.With the nozzle of the dispenser in its transfer position and connecting the conduits 30 and 80, the piston 36, initially pressed against the front wall 24, is pulled backwards. Under the action of the displacement of the piston 36, the solvent is progressively extracted from the pocket and is received in the confinement chamber 44, as shown in FIG. figure 3 . The air contained in the auxiliary chamber 46 is gradually evacuated through the auxiliary connection member 50. The air is released into the atmosphere, without consequence, this air being sterile.

Après remplissage de la chambre 44 d'une quantité de solvant satisfaisante, le flacon 13 est connecté. A cet effet, le goulot du flacon est introduit dans l'espace délimité par la collerette 74. L'opercule 15 est alors perforé à la fois par l'aiguille 72 et par l'aiguille 50.After filling the chamber 44 with a satisfactory amount of solvent, the bottle 13 is connected. For this purpose, the neck of the bottle is introduced into the space delimited by the flange 74. The cover 15 is then perforated by both the needle 72 and the needle 50.

Le boisseau 64 est alors tourné de 90° pour être amené dans sa position de préparation, de sorte que les conduits 30 et 70 sont reliés l'un à l'autre, le conduit 80 étant isolé. Dans cette position, la chambre de confinement 44 est reliée au flacon 13 au travers de l'aiguille 72, alors que la chambre auxiliaire de rappel 46 est reliée également au flacon 13 par l'organe auxiliaire de connexion formé de l'aiguille 50.The plug 64 is then rotated 90 ° to be brought into its preparation position, so that the conduits 30 and 70 are connected to each other, the conduit 80 being isolated. In this position, the confinement chamber 44 is connected to the bottle 13 through the needle 72, while the auxiliary return chamber 46 is also connected to the bottle 13 by the auxiliary connecting member formed of the needle 50.

Pour un fonctionnement correct, le flacon est placé avec son goulot orienté vers le haut et, comme illustré sur la figure 4, le piston est alors repoussé vers l'avant, conduisant à l'expulsion du solvant vers l'intérieur du flacon au travers, successivement, des conduits 30 et 70. Simultanément, le gaz en excès contenu dans le flacon 13 est aspiré dans la chambre auxiliaire de rappel 46 au travers de l'aiguille 50. Le gaz en excès contenu dans le flacon se trouve transféré vers la chambre de rappel sous l'action combinée de la surpression naissant dans le flacon 13 et sous l'action de l'aspiration de la chambre auxiliaire 46, du fait du déplacement du piston 36.For proper operation, the bottle is placed with its neck pointing upwards and, as shown in figure 4 the piston is then pushed forward, leading to the expulsion of the solvent into the vial through, successively, ducts 30 and 70. Simultaneously, the excess gas contained in the vial 13 is sucked into the auxiliary booster chamber 46 through the needle 50. The excess gas contained in the bottle is transferred to the booster chamber under the combined action of the emerging pressure in the bottle 13 and under the action of the suction of the auxiliary chamber 46, due to the displacement of the piston 36.

Tout le solvant contenu dans la chambre de confinement 44 est ainsi transféré vers le flacon. Le solvant se mélange alors avec la poudre constituant le principe actif cytotoxique.All the solvent contained in the confinement chamber 44 is thus transferred to the bottle. The solvent then mixes with the powder constituting the cytotoxic active principle.

Le flacon 13 est ensuite retourné, de sorte que l'extrémité libre de l'aiguille 72 soit en contact avec le mélange, comme illustré sur la figure 5. Le piston 36 est alors déplacé vers l'arrière du corps de seringue par traction sur la tige 34, comme illustré sur la figure 5. Le mélange est ainsi ré-aspiré dans la chambre de confinement 44 au travers, successivement, des conduits 70 et 30.The bottle 13 is then inverted, so that the free end of the needle 72 is in contact with the mixture, as illustrated in FIG. figure 5 . The piston 36 is then moved towards the rear of the syringe body by traction on the rod 34, as illustrated on the figure 5 . The mixture is thus re-sucked into the confinement chamber 44 through, successively, conduits 70 and 30.

Simultanément, le gaz préalablement aspiré dans la chambre auxiliaire de rappel 46 est réintroduit dans le flacon 13, pour occuper la place laissée libre par le mélange évacué vers la chambre de confinement 44.Simultaneously, the gas previously sucked into the auxiliary return chamber 46 is reintroduced into the bottle 13 to occupy the free space left by the mixture discharged to the confinement chamber 44.

Tout le mélange est ainsi ré-aspiré dans la seringue. Comme illustré sur la figure 6, le boisseau 64 est ensuite ramené dans sa position de transfert, assurant la liaison entre les conduits 30 et 80. Le mélange contenu dans la chambre de confinement 44 est alors réintroduit vers la poche 16 au travers, successivement, des conduits 30 et 80 sous l'action du piston 36 poussé axialement vers l'avant du corps de seringue. Lors de ce transfert, le flacon 13 reste connecté et du gaz extrait du flacon est aspiré dans la chambre de rappel. Ainsi, une légère dépression est créée dans le flacon 13.All the mixture is thus re-sucked into the syringe. As illustrated on the figure 6 , the plug 64 is then returned to its transfer position, providing the connection between the ducts 30 and 80. The mixture contained in the confinement chamber 44 is then reintroduced to the pocket 16 through, successively, conduits 30 and 80 under the action of the piston 36 pushed axially towards the front of the syringe body. During this transfer, the bottle 13 remains connected and gas extracted from the bottle is sucked into the return chamber. Thus, a slight depression is created in the bottle 13.

Après transfert de tout le mélange contenu dans la chambre de confinement 44 ou d'un volume déterminé à l'aide des graduations de la seringue, la poche 16 est séparée de la seringue par dégagement du nez 86 hors du culot 84. Sous l'action de l'élasticité du capuchon 90, celui-ci se détend alors le long de l'aiguille 82 pour couvrir complètement l'extrémité de celle-ci. Ainsi, le mélange encore contenu dans l'aiguille se trouve confiné à l'intérieur du capuchon 90, évitant tout transfert de mélange sous forme liquide et gazeux vers l'extérieur.After transfer of all the mixture contained in the confinement chamber 44 or a determined volume using the graduations of the syringe, the pocket 16 is separated from the syringe by disengaging the nose 86 from the base 84. action of the elasticity of the cap 90, it then relaxes along the needle 82 to completely cover the end thereof. Thus, the mixture still contained in the needle is confined within the cap 90, avoiding any transfer of mixture in liquid and gaseous form to the outside.

Avec un tel dispositif aucun dégagement gazeux contenant des molécules du principe actif cytotoxique n'est libéré dans l'atmosphère. En effet, les dégagements gazeux pouvant avoir lieu dans le flacon lors de la reconstitution du mélange extemporané lors des différentes phases d'utilisation de la seringue sont systématiquement confinée dans le flacon et/ou dans la chambre auxiliaire de rappel 46. Le flacon 14 et la seringue 46 restant définitivement solidarisés, aucun contact entre l'intérieur du flacon et la chambre 46 avec l'extérieur n'a lieu.With such a device, no gaseous release containing molecules of the cytotoxic active ingredient is released into the atmosphere. Indeed, the gas emissions that can take place in the bottle during the reconstitution of the extemporaneous mixture during the various phases of use of the syringe are systematically confined in the bottle and / or in the auxiliary booster chamber 46. The bottle 14 and the syringe 46 remaining permanently secured, no contact between the interior of the bottle and the chamber 46 with the outside takes place.

On conçoit qu'avec un tel dispositif, l'opérateur est protégé contre les éventuelles pollutions résultant de l'utilisation du principe actif cytotoxique.It is conceivable that with such a device, the operator is protected against possible pollution resulting from the use of the cytotoxic active ingredient.

Claims (10)

  1. A syringe (12) comprising:
    - a syringe body (18) in which is defined a fluid circulation passage (28), said circulation passage (28) being extended by a main member (20) for fluid connection to a supplementary volume (13), and
    - a movable piston (36) in the syringe body (18) bounding, with the syringe body (18), a fluid-containing chamber (44), which fluid-containing chamber (44) opens through said circulation passage (28),
    characterised in that the syringe body (18) bounds a closed space (44,46) in which the piston (36) is mounted for movement, which piston (36) bounds in this closed space, in addition to the fluid-containing chamber (44), an auxiliary return chamber (46), the syringe body (18) bounding a return passage (48) opening into said auxiliary return chamber (46), and in that said return passage (48) is extended by an auxiliary member (50) connecting to said supplementary volume (13).
  2. A syringe according to Claim 1, characterised in that said auxiliary connecting member comprises a hollow needle (50).
  3. A syringe according to Claim 1 or 2, characterised in that it comprises a piston-actuating rod (34) connected to the piston (36) and projecting outside the syringe body (18) from a rear end, said circulation passage (28) being formed at the front end of the syringe body (18), and in that said return passage (48) is formed in the vicinity of the rear end of the syringe body (18) and the auxiliary connecting member (50) extends along the length of the syringe body (18) of the return passage (48) in the vicinity of the front end.
  4. A syringe according to any one of the preceding Claims, characterised in that the main fluid connection member comprises a distributor (20) which includes a base (26) delimiting at least three circulation ducts and a valve (64) movable in relation to the base (26), a first duct (30) being connected to the circulation passage (28), a second duct comprising a conduit (70) for connection to said supplementary volume (13) and a third duct comprising a transfer conduit (80), said valve being movable between a transfer position, in which the first and third ducts are connected, and a preparation position in which the first and second ducts are connected.
  5. A syringe according to Claim 4, characterised in that the syringe body (18) and the distributor (20) cannot be separated.
  6. A syringe according to claim 4 or 5, characterised in that the transfer conduit (80) comprises a hollow needle (82).
  7. A syringe according to Claim 6, characterised in that said hollow needle (82) of the transfer conduit comprises a perforable and elastically deformable cap (90) covering the hollow needle (82).
  8. A syringe according to any one of Claims 4 to 7, characterised in that the connecting conduit (70) comprises a hollow needle (72).
  9. A syringe according to any one of Claims 2 and 8 taken together, characterised in that the free end sections of the hollow needles (50,72) of the auxiliary connecting member (50) and of the connecting conduit (70) are spaced apart by at least 1 cm.
  10. A reconstitution kit comprising a syringe (12) according to any one of the preceding Claims, and a supplementary volume (13) adapted for simultaneous connection to the fluid-containing chamber (44) and to the auxiliary return chamber (46) respectively through the main fluid connection member (20) and the auxiliary connecting member (50).
EP20050763666 2004-05-03 2005-04-27 Syringe for medical interventions and kit for reconstituting extemporaneous substances, comprising said syringe Active EP1744717B1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR0404717A FR2869533B1 (en) 2004-05-03 2004-05-03 SYRINGE FOR MEDICAL INTERVENTIONS AND NECESSARY FOR RECONSTITUTION OF EXTEMPORANEOUS SUBSTANCES COMPRISING SUCH A SYRINGE
PCT/FR2005/001046 WO2005120431A1 (en) 2004-05-03 2005-04-27 Syringe for medical interventions and kit for reconstituting extemporaneous substances, comprising said syringe

Publications (2)

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EP20050763666 Active EP1744717B1 (en) 2004-05-03 2005-04-27 Syringe for medical interventions and kit for reconstituting extemporaneous substances, comprising said syringe

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US (1) US7896849B2 (en)
EP (1) EP1744717B1 (en)
DE (1) DE602005009521D1 (en)
FR (1) FR2869533B1 (en)
WO (1) WO2005120431A1 (en)

Families Citing this family (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1874919B1 (en) 2005-04-21 2010-06-09 Massachusetts Institute Of Technology Materials and methods for altering an immune response to exogenous and endogenous immunogens, including syngeneic and non-syngeneic cells, tissues or organs
CN102743792B (en) 2005-06-21 2014-09-24 夏尔再生医学公司 Methods and compositions for enhancing vascular access
JP5062639B2 (en) 2006-04-24 2012-10-31 ノボ ノルディスク ヘルス ケア アーゲー Transfer system for forming a drug solution from a lyophilized drug
US20100185156A1 (en) * 2007-06-13 2010-07-22 Pervasis Therapeutics, Inc. Methods and Devices for Minimally-Invasive Delivery of Cell-Containing Flowable Compositions
WO2009146088A1 (en) * 2008-04-01 2009-12-03 Yukon Medical, Llc Dual container fluid transfer device
US8398583B2 (en) 2008-07-09 2013-03-19 Massachusetts Institute Of Technology Method and apparatus for extraction of a sample from a sample source
EP2337543B1 (en) 2008-10-15 2014-12-24 Novo Nordisk Health Care AG System for reconstitution of a powdered drug
ES2656488T3 (en) * 2009-05-04 2018-02-27 Valeritas, Inc. Fluid transfer device
IL200547A (en) * 2009-08-23 2014-06-30 Eli Shemesh Multiple vial drug mixing system
GB201001447D0 (en) * 2010-01-29 2010-03-17 Seldoren Ltd An assembly for delivering a fluid drug and method
WO2011119360A1 (en) * 2010-03-23 2011-09-29 Hyperbranch Medical Technology, Inc. Disposable syringe applicators for multi-component formulations, and methods of use thereof
WO2013066355A1 (en) * 2011-11-04 2013-05-10 Spectrum Pharmaceuticals, Inc Safely preparing and administering drug substances
US9352095B2 (en) * 2012-04-06 2016-05-31 Baxter International, Inc. Container system
WO2015153828A1 (en) 2014-04-04 2015-10-08 Hyperbranch Medical Technology, Inc. Extended tip spray applicator for two-component surgical selant, and methods of use thereof
IL239366B (en) 2015-06-11 2018-07-31 Kriheli Marino Components of a fluid transfer apparatus
JP7001273B2 (en) 2016-01-29 2022-01-19 クリーデンス メドシステムズ，インコーポレイテッド Systems and methods for the preparation of injectable ingredients
JP7000443B2 (en) * 2017-03-10 2022-02-10 イネイブル インジェクションズ、インコーポレイテッド Reconstructor, system and method
USD923812S1 (en) 2019-01-16 2021-06-29 West Pharma. Services IL, Ltd. Medication mixing apparatus
JP7101900B2 (en) 2019-01-31 2022-07-15 ウェスト・ファーマ・サービシーズ・アイエル・リミテッド Liquid transfer device
JP7275747B2 (en) * 2019-03-28 2023-05-18 大日本印刷株式会社 Chemical liquid delivery device and chemical liquid delivery method
IL277446B2 (en) 2019-04-30 2024-02-01 West Pharma Services Il Ltd Liquid transfer device with dual lumen iv spike
US11340104B2 (en) * 2020-07-07 2022-05-24 Matthew Moers Syringe with a valve in a housing for measuring chemicals
USD956958S1 (en) 2020-07-13 2022-07-05 West Pharma. Services IL, Ltd. Liquid transfer device

Family Cites Families (27)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE1278703B (en) * 1967-01-21 1968-09-26 Penicillin Ges Dauelsberg & Co Two-chamber syringe
US3626928A (en) * 1970-06-22 1971-12-14 Becton Dickinson Co Intrauterine washing apparatus
US3957052A (en) * 1974-09-13 1976-05-18 Medical Development Corporation Pumping-syringe
US4206768A (en) * 1978-10-20 1980-06-10 Marquest Medical Products, Inc. Syringe device with means for selectively isolating a blood sample after removal of contaminates
US4237880A (en) * 1979-02-28 1980-12-09 Abbott Laboratories Equipment sets for the sequential administration of medical liquids at dual flow rates employing a combined air barrier and liquid sequencing valve controlled by a common flexible membrane
US4447235A (en) * 1981-05-07 1984-05-08 John M. Clarke Thoracentesis device
US4532969A (en) * 1983-09-21 1985-08-06 Kwaan Hau C Fluid withdrawal and instillation device
GB8401754D0 (en) * 1984-01-24 1984-02-29 Bilbate Ltd Fluid sampling device
US4900322A (en) * 1986-09-22 1990-02-13 Adams James D Blood component pooling valve and kit
US4824434A (en) * 1987-01-14 1989-04-25 Seitz Jr H Michael Apparatus used in a method for removing tissue and living organisms from human body cavities
DE3876000D1 (en) * 1987-04-24 1992-12-24 Aldo Venturini SAFETY DISPOSAL SYRINGE.
US5078864A (en) * 1990-02-23 1992-01-07 Nature's Sunshine Products, Inc. High flow rate reverse osmosis water filtration system for home use
US5042979A (en) * 1990-04-23 1991-08-27 Mark Anderson Closed loop system for embryo retrieval
DK0591152T3 (en) * 1990-11-02 1996-07-22 Marion Giebel Infection prevention catheter device
US5360410A (en) * 1991-01-16 1994-11-01 Senetek Plc Safety syringe for mixing two-component medicaments
DE4122221A1 (en) * 1991-07-04 1993-03-18 Axel Von Brand TRANSFER AND REMOVAL SPIKE
US5286257A (en) * 1992-11-18 1994-02-15 Ultradent Products, Inc. Syringe apparatus with detachable mixing and delivery tip
US5522804A (en) * 1994-02-15 1996-06-04 Lynn; Lawrence A. Aspiration, mixing, and injection syringe
US5466220A (en) * 1994-03-08 1995-11-14 Bioject, Inc. Drug vial mixing and transfer device
US5564629A (en) * 1994-06-07 1996-10-15 William R. Weissman Oral irrigating apparatus and method for selectively mixing and discharging a plurality of liquids
IL114960A0 (en) * 1995-03-20 1995-12-08 Medimop Medical Projects Ltd Flow control device
US6050957A (en) * 1998-07-01 2000-04-18 Desch; Larry W. Multiple-draw, variable suction syringe
US6558537B1 (en) * 1999-05-25 2003-05-06 Miox Corporation Portable hydration system
JP4359671B2 (en) * 1999-09-29 2009-11-04 アークレイ株式会社 Body fluid collection tool
BR0208068A (en) * 2001-03-13 2005-04-19 Mdc Invest Holdings Inc Medical device and process for injecting medicine
JP4838955B2 (en) * 2001-08-21 2011-12-14 武田薬品工業株式会社 Two-chamber prefilled syringe
US7455658B2 (en) * 2004-11-10 2008-11-25 Samw Hong Jen Wang Fluid dispensing or feeding device

Also Published As

Publication number Publication date
DE602005009521D1 (en) 2008-10-16
US7896849B2 (en) 2011-03-01
FR2869533B1 (en) 2006-07-28
EP1744717A1 (en) 2007-01-24
WO2005120431A1 (en) 2005-12-22
FR2869533A1 (en) 2005-11-04
US20080009790A1 (en) 2008-01-10

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