EP2779981B1 - Dispositif d'interfaçage d'un instrument d'injection de fluide et d'un flacon à perforer et procédé d'utilisation associé - Google Patents

Dispositif d'interfaçage d'un instrument d'injection de fluide et d'un flacon à perforer et procédé d'utilisation associé Download PDF

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Publication number
EP2779981B1
EP2779981B1 EP12784289.6A EP12784289A EP2779981B1 EP 2779981 B1 EP2779981 B1 EP 2779981B1 EP 12784289 A EP12784289 A EP 12784289A EP 2779981 B1 EP2779981 B1 EP 2779981B1
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EP
European Patent Office
Prior art keywords
interfacing device
vial
base
distal
proximal
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP12784289.6A
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German (de)
English (en)
French (fr)
Other versions
EP2779981A1 (fr
Inventor
Isabelle Algrain
Jean-Luc Carrez
Jean-Louis Coussegal
Pierrick Guyomarc'h
Marie-Hélène PECH
Patrick Lestoquoy
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Vygon SA
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Vygon SA
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Filing date
Publication date
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Publication of EP2779981A1 publication Critical patent/EP2779981A1/fr
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Publication of EP2779981B1 publication Critical patent/EP2779981B1/fr
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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/003—Filling medical containers such as ampoules, vials, syringes or the like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096—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
    • A61J1/2003—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
    • A61J1/202—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
    • A61J1/2055—Connecting means having gripping means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2068—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
    • A61J2200/00—General characteristics or adaptations
    • A61J2200/10—Coring prevention means, e.g. for plug or septum piecing members

Definitions

  • the invention relates to an interface device for connecting a fluid injection instrument such as a syringe and a vial to be perforated (called Vial) containing a medicament for the purpose of preparing fluids intended to be perfused in a patient.
  • Vial a fluid injection instrument
  • Vial a vial to be perforated
  • the drug to be administered is in powder form in a vacuum vial, which is sealed with an elastomeric membrane stopper.
  • the fluid to be infused may for example be physiological saline (distilled water + NaCl).
  • the elastomeric membrane cap is then passed through the vial with the needle, causing air to enter the vial which has been under vacuum.
  • This air mixes with the drug in the form of powder and can come out in part by bringing pure drug, which is dangerous for the care staff responsible for the preparation.
  • the nursing staff responsible for the preparation pushes with the syringe fluid to be infused into the bottle, which again, again, air initially enclosed in the bottle loaded if necessary drug particles not yet diluted.
  • the vial is then shaken and the mixture is sucked through the elastomeric membrane cap using the syringe.
  • the liquid infusion mixture plus diluted drug is injected and sucked several times in and out of the vial with the syringe, in order to thoroughly mix the drug in the liquid.
  • such a mixture causes inflows and outflows of the bottle, which involves the risk of pollution on the one hand for the health care staff responsible for the preparation, and on the other hand for the prepared mixture.
  • the needle is out of the bottle. It must then be disconnected from the syringe without stinging and avoid direct contact of the mixture thus made with the care staff responsible for the preparation.
  • the filled syringe is then connected near the patient to an infusion bag connected thereto or connected directly to the patient himself.
  • the main causes of accidents are related to liquid and gas tightness problems inside the Vial towards the outside environment, with the release of dangerous products that can come into contact with the skin.
  • the eyes and the respiratory system of the staff preparer and carer, but also to problems of sealing of the external environment towards the interior of the Vial which may contaminate the preparation, or problems of vertical stability of the interfacing device . It may therefore be necessary for the preparatory personnel to work in confined spaces, under hoods or in enclosures, and with thick gloves.
  • Interfacing devices such as that of the document are already known.
  • WO2006 / 138184 The document FR 2 928 539 proposes another interfacing device comprising air circulation means, intended to allow inflow and outflow of the vial to be perforated, provided with air filtration means adapted to retain the particles of pure medicament not yet diluted at the outlet of air from the bottle, as well as impurities contained in the ambient air entering the bottle when air enters the bottle.
  • the device thus makes it possible to secure the handling and preparation of the mixture.
  • the filtering means which is generally in the form of an exhaust filter, is very sensitive to liquids and filtering does not seem sufficiently effective for users.
  • the device is relatively complex to produce and comprises a large number of parts.
  • an interfacing device comprising a base on which is fixed an air tank via air circulation means, wherein the air tank comprises a rigid shell associated with a flexible membrane, defining an isolated compartment of the outside.
  • This improved air circulation system then replaces the filter and allows air circulation in the Vial, while maintaining the Vial isolated from the outside and therefore the risk of contamination by external elements.
  • Such interfacing device has good features and can effectively limit the risk of contamination.
  • its design is very expensive and complex.
  • An object of the invention is therefore to provide an interfacing device which is lower cost and less complex to achieve, while reducing the risk of contamination, whether the content of Vial by external elements or personnel preparer or caring for the contents of the Vial.
  • the invention also aims to provide an interfacing device that is stable in all positions and during handling when attached to the Vial.
  • the proximal ring may be adapted to be fixed by gluing, welding, locking or by means of an elastic sleeve on the base.
  • an interfacing device 1 is intended to be mounted on a perforating bottle 2 (or Vial) at its distal end 1a, and on a fluid injection instrument, such as a syringe (not shown in the figures), at its proximal end 1b.
  • the interfacing device 1 comprises in particular a base 10, a proximal end of which is provided with connection means 15 with the syringe, perforation means 30 extending from the base 10 in the distal direction of the device 1, and a fixing means 20 of the interfacing device 1 on the Vial 2.
  • connection means 15 will be chosen which may limit the risk of droplet formation and can be easily cleaned, since the drugs obtained may be harmful for the operator. It may in particular refer to the connectors described in the patent application FR 1160164, filed on November 8, 2011 in the name of the Claimant.
  • the base 10 comprises a body, which may for example be derived from molding, comprising a generally cylindrical longitudinal chamber 14 opening distally on a conduit 16. figure 4 for example, the chamber 14 is frustoconical in shape and the duct 16 is tubular.
  • a lateral orifice 11 opening into the conduit 16 is formed in the body of the base 10, at which is fixed a variable volume tank 50. Examples of such tanks 50 will be developed further in the description.
  • the perforation means 30, here a needle extends longitudinally from a distal end of the chamber 14 through the conduit 16.
  • the needle 30 is preferably fixed relative to the base 10, and extends the case next to the lateral orifice 11 of the base 10.
  • the needle 30 has at its distal end a tip 31, which can optionally be beveled.
  • the base 10 further comprises a cannula 40, sealingly attached to the base 10, preferably at a distance (along a main axis of extension X of the device of FIG. interfacing 1) of the lateral orifice 11 so as to leave a space between the distal end of the chamber 14 and the proximal end of the cannula 40.
  • the interfacing device 1 comprises at a distal end 1a a fixing means 20 of the base 10 on the Vial 2.
  • the fixing means 20 may be fixed between the distal end of the cannula 40 and the tip 31 of the needle 30, for example by overmolding, gluing, welding, etc. on the needle 30, so as to ensure good mechanical adhesion with the needle 30.
  • the outer surface of the needle 30 can be treated in the attachment zone of the fixing means 20 so as to increase the friction between the two parts, for example by sandblasting said zone.
  • the fixing means 20 has a diverging proximal end 21 forming a shoulder and a convergent distal end 22 adapted to facilitate its penetration into the membrane 3 of the Vial 2.
  • the fixing means 20 may comprise a body 23 having a frustoconical shape. of revolution, whose distal portion 22 is of diameter substantially equal to the outer diameter of the needle 30, and whose proximal portion 21 has a substantially larger diameter, typically twice as large.
  • the fastening means 20 can easily be inserted through the membrane 3 of the Vial 2, thanks to the tapered shape of the fastening means 20, and then remains locked inside the Vial 2, insofar as the part proximal 21 of the fastening means 20 forms a shoulder which bears against an inner surface of the membrane 3 of the Vial 2 and prevents its exit, even in the case of a possible traction on the needle.
  • the fixing means 20 has the shape of a harpoon, and comprises, in addition to the frustoconical body of revolution 23, at least two tabs 21a which extend in the proximal direction so as to reinforce the shoulder formed by the part proximal 21 of the fixing means.
  • a pull on the needle 30 anchors indeed the tabs 21a of the fixing means 20 in the membrane 3 of the Vial 2, thus reinforcing the tear resistance of the fastening means 20.
  • the number of tabs 21a is of course not limiting, and may be equal to three, four or more. Nevertheless, a limited number of tabs 21a will be preferred, of the order of two to four, so as to avoid the risk of damage to the membrane 3.
  • the tabs 21a are then distributed angularly so that the means 20 is symmetrical.
  • the fixing means 20 makes it possible to put in fluid communication the flask to be perforated 2 with an external space 4 to the interfacing device 1.
  • an internal diameter of the cannula 40 is greater than an external diameter of the needle 30 , so as to create an annular channel 35 between the needle 30 and the cannula 40.
  • the annular channel 35 thus opens in the proximal portion in the conduit 16 so as to be in fluid communication with the lateral orifice 11 of the base 10.
  • the annular channel 35 opens at its distal end outside the interfacing device 1, so that the variable volume reservoir 50 can be in fluid communication with the external environment by the attachment means 20 via the annular channel 35 and the lateral orifice 11.
  • the fastening means inserted into the Vial the variable volume reservoir is then in fluid communication with the interior of the Vial via the annular channel 35 and the lateral orifice 11.
  • the fixing means 20 may comprise at least one notch 24 extending transversely to the needle 30, and opening on the distal portion of the annular channel 35.
  • the fastening means 20 may comprise at least one notch 24 between each lug 21 a.
  • the arrangement of the notches 24 in the fastening means 20 relative to the distal end of the annular channel 35 is such that at any time the annular channel 35 opens into the Vial 2, even in case of traction on the interfacing device by the operator.
  • This is allowed here by the implementation of the tabs 21a of the fastening means 20 which, in case of traction on the device 1, prevent the needle 30 from going up beyond the indentations, thus ensuring that the annular channel 35 opens at any time in Vial 2.
  • the interfacing device 1 may also comprise a bypass means (not shown in the figures) adapted to put in fluid communication the surrounding medium to the fastening means 20 with the lateral orifice 11
  • a bypass means may for example be a pipe extending along the cannula 40 between the lateral orifice 11 and the indentation (s) 24.
  • variable volume tank 50 The objective of the variable volume tank 50 is to have a reserve of gas 51 from a closed system without contact with the outside, in order to limit or even cancel the gas exchanges between the Vial 2 and outside.
  • the maximum internal volume of the variable volume tank 50 is at least equal to the internal volume of the Vial 2.
  • the reservoir 50 initially contains a sterile gas, for example sterile air.
  • a sterile gas for example sterile air.
  • the gas initially contained in the tank 50 can be discharged through the notch 24 before insertion into the Vial 2, especially when the Vial 2 initially contains powder and a gas, or only after insertion.
  • the operator preferably evacuates the gas initially contained in the tank 50 before inserting the fixing means 20 into the Vial 2. so when the syringe is connected to the means connection 15 of the interfacing device 1, and that the fluid it contains is inserted into the Vial to solubilize the product in powder form, the gas initially contained in the Vial is driven via the indentations 24, the annular channel 35 and the lateral orifice 11 of the base 10 towards the reservoir 50. Then, in a second step, when the fluid is sucked by the syringe with the product in the form of powder and liquid, the gas driven into the reservoir 50 is Vacuum sucked into the Vial 2. The injection and suction cycle of the powdered fluid can then be repeated until complete solubilization or homogenization is achieved.
  • the system formed by the interfacing device 1, the Vial 2 and the syringe is thus closed and makes it possible to avoid any risk of escape of air and aerosolization towards the outside environment thanks to the variable volume reservoir 50
  • the system comprising the interfacing device 1 and the Vial 2 is sterile before perforation of the membrane 3 of the Vial 2 and remains sterile after perforation, since There is no gas exchange with the outside.
  • the operator in the case of a Vial 2 initially containing a fluid product, the operator preferably does not evacuate the gas initially contained in the variable volume tank 50 before inserting the fixing means 20 in the Vial 2 Indeed, when the operator sucks the fluid contained in the Vial with the syringe, the gas initially contained in the reservoir is sucked via the lateral orifice 11 of the base 10, the annular channel 35 and the notches 24 to fill the Vial 2.
  • the gas In order to facilitate the injection and suction operations of the powdered fluid, the gas must preferably be able to easily circulate from the Vial 2 to the tank 50 and vice versa.
  • This circulation is simplified here thanks in particular to the absence of valves and filters, these being no longer useful insofar as the device 1 of the invention is in a closed circuit. Indeed, the fluids used are often relatively viscous and therefore require significant effort on the part of the operator, especially during aspiration.
  • variable volume reservoir 50 may be an elastomeric balloon.
  • the balloon 50 is preferably attached to a side track 17 of the base 10 adjacent to the side port 11, or at least is in fluid communication therewith.
  • the balloon 50 can be glued or fixed on the base 10 by means of a ligature or a sleeve 53 tightening the lateral lane 17.
  • the balloon 50 may extend transversely to the main axis of extension X of the interfacing device 1, as illustrated in FIG. figure 5a .
  • the balloon 50 can be inclined with respect to this axis X so as to bring its center of gravity closer to said axis X (see figures 1b and 5b). In this way, when the interfacing device 1 is fixed on the Vial 2, the assembly is more balanced and more stable than when the balloon extends transversely. Moreover, this configuration allows any drops sucked with gas during handling to flow and return to the Vial 2 by gravity.
  • the balloon 50 may also extend around the main axis of extension X of the interfacing device 1.
  • variable volume reservoir 50 can also be made in the form of a rigid reservoir extending around the base 10, transversely to the main axis of extension X of the interfacing device 1 , and comprise two complementary parts movable in translation relative to each other so as to allow to modulate the internal volume located between said parts.
  • the parts may be a rigid casing 51, having a generally cylindrical shape, and closed at its proximal and distal ends by trays 12, 13, extending from the base 10.
  • the plates 12 and 13 extend transversely to the axis X, and the housing 51 is movable in translation in a direction parallel to said axis, between the two plates 12, 13.
  • the casing 51 is assembled in a sealed manner with the trays 12 and 13, for example by means of seals 52.
  • the housing 51 comprises a proximal portion 51a, cylindrical in shape and complementary to the shape of the proximal plate 12, and a distal portion 51b, of cylindrical shape and complementary to the distal plate 13.
  • the reservoir 50 is further provided with seals 52, preferably disposed between the proximal portion 51a and the proximal plate 12 on the one hand, and between the distal portion 51b and the distal plate 13 on the other hand.
  • the casing 51, the trays 12, 13 and the seals 52 are cylindrical of revolution. Furthermore, the trays 12 and 13 are fixed relative to the base 10, only the housing 51 being movable in translation along the axis X, according to the necessary volume of the tank 50. The trays 12 and 13 can then be formed integrally with the base 10, overmolded thereon or reported.
  • volume of air 53 trapped in the tank depends on the distance between the two plates 12 and 13 and their respective surfaces.
  • the distal portion 51b of the casing 51 abuts against the upper surface of the distal plate 13 and the proximal portion 51a abuts against the proximal plate 12, so that the internal volume 53 of the reservoir 50 is zero.
  • the housing 51 slides in the direction of the arrow A along the trays 12 and 13, thus sucking the gas contained in the Vial 2.
  • the internal volume 53 of the casing 51 is maximal and its distal end is in abutment against the distal plate 13.
  • the housing 51 may be fixed relative to the base 10 while the trays 12 and 13 may be movable along the X axis, or both the housing 51 and the trays 12, 13 may be movable in translation.
  • such a tank 50 being rigid, it does not present the risk of being accidentally perforated during storage or manipulation by an operator. Furthermore, the sliding of the housing 51 along the trays 12 and 13 makes it possible to vary in a simple and stable manner the volume of the tank 50 without destabilizing the interfacing device 1.
  • the Applicant has found that, because of the quality of the membrane 3 of the Vial 2, it could happen that one or more drops of the fluid sucked or injected into the Vial flows along the cannula 40, despite the fact that use of a fastening means according to the invention, and all the more so when the cannula 40 itself is brought into contact with the fluid (which is possible when using the device 1, as we see later in the description).
  • the interfacing device 1 may, optionally, furthermore comprise a protection member 60 of the fixing means 20 and of the cannula 40.
  • a device protection member 60 may for example be in the form of a casing 61 extending between a diametrically opposed proximal ring 62 and a distal ring 63, the proximal ring 62 being adapted to be fixed on the base 10 so that the envelope 61 completely or partially covers the distal portion 1a of the interfacing arrangement 1, in order to limit the risk of contamination of the operator and the contents of the Vial 2.
  • the envelope 61 of the protection member 60 completely covers the cannula 40 and the fixing means 40, in order to avoid any risk of contamination.
  • the proximal ring 62 and the distal ring 63 are adapted to be fixed respectively to the base 10 and a neck of the Vial 2 so as to define an internal volume.
  • the latter may further comprise a means of gripper 64, for example two gripping strips extending on either side of the distal ring 63.
  • proximal ring 62 of the protective member 60 which may for example be of circular or elliptical shape, may be fixed by gluing, welding, locking or by means of an elastic sleeve at a portion 18 of the base 10.
  • the distal ring 63 meanwhile can be applied in force on the neck of the Vial 2, preferably with tight tightness.
  • the distal ring 63 may for example be circular.
  • the distal ring 63 is elliptical in shape to improve the tightness of the device 60 on the Vial neck. Any gripping strips 64 are then preferably disposed on either side of its major axis, so that traction on the strips 64 towards the neck of the Vial 2 increases the length of the minor axis of the distal ring 63 and facilitates its fitting on the neck of Vial 2.
  • the dimensions of the major axis of the distal ring 63 may be smaller. than the diameter of the neck of Vial 2.
  • At least one of the gripping strips 64 may have an adhesive surface protected, if necessary, by a peelable film (typically a silicone paper).
  • a peelable film typically a silicone paper
  • the facing surfaces of the two gripping strips 64 are adhesive-coated.
  • variable volume tank 50 the operator flushes the gas initially contained in the variable volume tank 50.
  • a balloon 50 it suffices to press it until all the gas is removed from it, while in the case of the rigid tank 50 illustrated in particular on the Figures 6a to 6c , the operator must slide the housing 51 along the base 10 until it abuts against the plates 12 and 13.
  • the operator can then perforate the membrane 3 of the Vial 2 by pushing the tip 31 of the needle 30 through the membrane 3.
  • the Vial 2 can be placed vertically on a support, the collar upwards. , and the tip 31 of the needle 30 can be pressed into the membrane 3 from top to bottom.
  • the interfacing device 1 comprises a protection member 60, which may optionally be pre-fixed on the base 10, the operator fixes the distal ring 63 of the protection member 60 on the Vial 2 neck, to avoid any contamination by the product it contains.
  • connection 15 of the interfacing device the operator connects the syringe by means of connection 15 of the interfacing device 1, taking care to avoid any drop formation in order to limit the risks of contamination, and injects a fluid into the Vial 2.
  • the injection of fluid into the Vial 2 has the effect of driving the gas initially present in the Vial 2 to the tank 50, whose internal volume then increases proportionally to the gas received.
  • the casing 51 slides for example until it comes into abutment with the distal plate 13.
  • a third step the operator sucks and then repeatedly reinjects the fluid loaded product, so as to solubilize the product in the form of powder in the fluid and to homogenize.
  • This manipulation can in particular be facilitated by turning over the assembly formed by the syringe, the Vial 2 and the interfacing device, so that the Vial 2 is above the interface device 1 and that the fluid it contains flows by gravity to his collar.
  • This position is indeed more ergonomic for the operator and less tiring, especially when the fluid is viscous.
  • the protection member 60 thanks to the use (optional) of the protection member 60, the operator is protected from any drops that could slide along the cannula 40 during handling, in case of membrane 3 of poor quality or deteriorated, or improper handling of the device 1.
  • the fixing means 20 is preferably pressed into the Vial 2 so that the notch 24 and the distal portion of the annular channel 35 are located. above the fluid level, that is to say in the space of the Vial which contains the gas, so as to prevent fluid from entering the annular channel 35 and flows into the tank 50. Otherwise, it would indeed be necessary for the operator to provide a greater effort to inject the liquid into the Vial 2, besides this increase in pressure may further facilitate the passage of fluid in the annular channel 35.
  • the operator For the aspiration of the fluid by the syringe, the operator must make sure that the tip 31 of the needle 30 is immersed in the fluid to avoid sucking the gas with the syringe. If, however, gas is sucked in, the operator could nevertheless empty the air of the syringe in a conventional manner, preferably by injecting it into the Vial 2 in order to avoid any risk of contamination by the product.
  • the fluid level decreases in the Vial 2 to reach the tip 31 of the needle 30. It is then possible to pull the needle 30, in order to lower the tip 31 and keep it below the level of the fluid. Then, when this is no longer possible due to the presence of the fastening means which prevents the tip 31 of the needle 30 from coming out beyond a certain point of the Vial, the operator can then return the assembly. formed by the Vial 2, the interfacing device 1 and the syringe, and push the needle 30 to the bottom of the Vial so as to reach the remaining fluid.
  • the operator can notably rotate the needle 31 in the Vial 2, as shown in FIG. figure 8 .
  • the connection between the cannula 40 and the membrane 3 is in fact of the ball-and-socket type because of the flexibility of the membrane 3 and the shape of the cannula 40, and thus allows the operator to access the entire internal volume of the Vial 2. It will therefore be understood that the usefulness of the protective member 60 (optional) in the case where the operator actually depresses the cannula 40 at the bottom of the Vial 2, since it comes into contact with the product contained by the Vial 2 and can remain on the cannula 40 when the operator extracts it from the Vial 2.

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  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
EP12784289.6A 2011-11-15 2012-11-15 Dispositif d'interfaçage d'un instrument d'injection de fluide et d'un flacon à perforer et procédé d'utilisation associé Active EP2779981B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR1160397A FR2982484B1 (fr) 2011-11-15 2011-11-15 Dispositif d'interfacage d'un instrument d'injection de fluide et d'un flacon a perforer et procede d'utilisation associe
PCT/EP2012/072743 WO2013072421A1 (fr) 2011-11-15 2012-11-15 Dispositif d'interfaçage d'un instrument d'injection de fluide et d'un flacon à perforer et procédé d'utilisation associé

Publications (2)

Publication Number Publication Date
EP2779981A1 EP2779981A1 (fr) 2014-09-24
EP2779981B1 true EP2779981B1 (fr) 2016-05-18

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EP12784289.6A Active EP2779981B1 (fr) 2011-11-15 2012-11-15 Dispositif d'interfaçage d'un instrument d'injection de fluide et d'un flacon à perforer et procédé d'utilisation associé

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US (1) US9701427B2 (ko)
EP (1) EP2779981B1 (ko)
JP (1) JP5951032B2 (ko)
KR (1) KR101996378B1 (ko)
BR (1) BR112014011598B1 (ko)
CA (1) CA2855259C (ko)
ES (1) ES2587519T3 (ko)
FR (1) FR2982484B1 (ko)
PT (1) PT2779981T (ko)
WO (1) WO2013072421A1 (ko)

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Publication number Priority date Publication date Assignee Title
CN104244905B (zh) 2012-03-01 2019-06-04 贝克顿迪金森有限公司 压力平衡装置和储器
FR3011735B1 (fr) * 2013-10-16 2016-10-14 Vygon Dispositif d'interfacage d'un flacon a perforer
US11571362B2 (en) 2018-01-04 2023-02-07 Elcam Medical A.C.A.L. Vial adaptor assembly for a closed fluid transfer system

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR1160164A (fr) 1956-11-07 1958-07-08 Anciens Etablissements Bayoux Garniture calorifuge et son procédé de fabrication
WO1984004673A1 (en) * 1983-05-20 1984-12-06 Bengt Gustavsson A device for transferring a substance
US5527306A (en) * 1994-04-18 1996-06-18 Haining; Michael L. Vial adapter
US20070078429A1 (en) * 2005-06-15 2007-04-05 Inviro Medical Devices Ltd. Safety fluid transfer cannula
US7547300B2 (en) * 2006-04-12 2009-06-16 Icu Medical, Inc. Vial adaptor for regulating pressure
US7900659B2 (en) * 2006-12-19 2011-03-08 Carefusion 303, Inc. Pressure equalizing device for vial access
FR2928539B1 (fr) * 2008-03-12 2012-02-24 Vygon Dispositif d'interfacage pour flacons a perforer a fins de preparations de liquides perfuses
US8523838B2 (en) * 2008-12-15 2013-09-03 Carmel Pharma Ab Connector device
FR2951638B1 (fr) * 2009-10-28 2012-05-25 Vygon Dispositif d'interfacage pour flacons a perforer

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Publication number Publication date
FR2982484A1 (fr) 2013-05-17
ES2587519T3 (es) 2016-10-25
US20140283948A1 (en) 2014-09-25
BR112014011598A2 (pt) 2017-05-30
US9701427B2 (en) 2017-07-11
JP2014533161A (ja) 2014-12-11
PT2779981T (pt) 2016-08-24
JP5951032B2 (ja) 2016-07-13
KR20140102222A (ko) 2014-08-21
FR2982484B1 (fr) 2016-04-22
BR112014011598B1 (pt) 2020-06-30
KR101996378B1 (ko) 2019-07-04
WO2013072421A1 (fr) 2013-05-23
CA2855259C (fr) 2020-03-31
CA2855259A1 (fr) 2013-05-23
EP2779981A1 (fr) 2014-09-24

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