EP0792135A1 - Spritzenvorrichtung befestigbar an einem fläschchen - Google Patents

Spritzenvorrichtung befestigbar an einem fläschchen

Info

Publication number
EP0792135A1
EP0792135A1 EP95940304A EP95940304A EP0792135A1 EP 0792135 A1 EP0792135 A1 EP 0792135A1 EP 95940304 A EP95940304 A EP 95940304A EP 95940304 A EP95940304 A EP 95940304A EP 0792135 A1 EP0792135 A1 EP 0792135A1
Authority
EP
European Patent Office
Prior art keywords
syringe
guide piece
guide
bottle
piece
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.)
Granted
Application number
EP95940304A
Other languages
English (en)
French (fr)
Other versions
EP0792135B1 (de
Inventor
Frédéric Neftel
Bernard Bouvier
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Debiotech SA
Original Assignee
Debiotech SA
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Priority claimed from FR9413605A external-priority patent/FR2726767A1/fr
Application filed by Debiotech SA filed Critical Debiotech SA
Publication of EP0792135A1 publication Critical patent/EP0792135A1/de
Application granted granted Critical
Publication of EP0792135B1 publication Critical patent/EP0792135B1/de
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096Combination of a vial and a syringe for transferring or mixing their contents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006Piercing means
    • A61J1/201Piercing means having one piercing end
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048Connecting means
    • A61J1/2051Connecting means having tap means, e.g. tap means activated by sliding
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048Connecting means
    • A61J1/2065Connecting means having aligning and guiding means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2068Venting means
    • A61J1/2075Venting means for external venting
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2079Filtering means
    • A61J1/2082Filtering means for gas filtration
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S604/00Surgery
    • Y10S604/905Aseptic connectors or couplings, e.g. frangible, piercable

Definitions

  • the subject of the present invention is a syringe device which can be fixed on a vial, in particular a vial containing a liquid to be injected or a lyophilized product which must be mixed with a physiological liquid or with a medicament in order to inject the mixture.
  • the most frequently used solution consists in storing the powder in a separate container which is closed by a membrane or a leaktight stopper punctured using a needle. Furthermore, with a standard type syringe, a certain amount of solvent is withdrawn from a second container and the desired quantity of solvent is injected into the first container through the membrane. The whole is then mixed in the first container and, using the same syringe, the mixture is aspirated. The syringe is then ready to inject the medicine.
  • the liquid for example physiological saline
  • the liquid is already contained in the syringe. It then suffices to inject the liquid through the perforable membrane into the container containing the product in the form of powder and then to aspirate the assembly after mixing.
  • An object of the present invention is to provide a syringe device which can be fixed on a bottle which ensures the perforation of the perforable stopper in its center and which, moreover, makes this operation very safe and perfectly repetitive.
  • an object of the present invention is to provide such a device which is adaptable to the bottle commonly used to contain medicated powders to be mixed with a solvent and in particular lyophilized products.
  • the syringe device which can be fixed on a bottle having a cylindrical body ⁇ t an opening surrounded by a flange having a lateral face and a perforable plug closing off said opening, is characterized in that it comprises a guide piece capable of cooperating with said vial and a syringe provided with a needle and slidably mounted in said guide piece, said guide piece comprising a first open end having at its end portion a first internal guide surface capable of cooperating with the cylindrical body of said bottle, and means for securing said part to said flange disposed in withdrawal with respect to said first internal guide surface, said securing means being activated when said device is placed on said bottle, said guide piece comprising a second end and a running part capable of receiving see said syringe provided with means for guiding in translation of said syringe in said guide piece to bring said syringe into a depressed position in which the needle pierces the perforable membrane of the vial,
  • the presence of the securing elements makes it possible to secure the guide piece and therefore the syringe on the vial, which makes it easier to handle the syringe relative to the vial.
  • this makes it possible to very precisely control the insertion of the syringe into the guide piece and therefore the penetration of the tip of the needle into the bottle after perforation of the stopper, so that the penetration is reduced to the maximum.
  • the latter can be separated from the guide piece.
  • the first end of the guide piece has a second internal guide surface capable of cooperating with the side wall of the flange of the bottle, the securing means being arranged between the first and second guide surfaces.
  • the presence of these two guide surfaces makes it possible to reduce the length of the first guide surface while obtaining rigorous centering of the guide piece relative to the bottle.
  • the means for guiding in translation of the syringe in the guide piece comprise sealing means for sealing between the internal face of the guide piece and the body of said syringe.
  • the means for guiding the syringe in the guide piece comprise at least one guide face formed in the internal face of the guide piece capable of cooperating with a portion of the body of said syringe.
  • the guide piece comprises a plate element disposed substantially perpendicular to the direction of movement of the syringe in which said central orifice is formed, the face of said plate turned towards the first end of the guide piece being provided with a projecting annular rib surrounding said central orifice, whereby said rib is applied against the stopper of said bottle when said securing means cooperate with said bottle.
  • FIG. 1 is a vertical sectional view of a vial usable with the syringe device according to the invention
  • - Figure 2 is a section of a first embodiment of the syringe device
  • FIG. 3 is a perspective view of the syringe device attached to a vial
  • Figure 4a is a detail view of Figure 2 showing the attachment of the syringe device on a vial;
  • FIG. 4b is a horizontal sectional view along line B- B of Figure 4a;
  • FIG. 5 is a vertical sectional perspective view of a second embodiment of the syringe device attached to a vial;
  • FIG. 7 shows in partial vertical section a third embodiment of the syringe device. Referring first to Figure 1, we will describe a bottle
  • the bottle 10 of standard type containing for example a medicament in lyophilized form.
  • the bottle 10 comprises a cylindrical body 12 and a neck 14 limiting an opening 16.
  • the neck 14 is surrounded by a cylindrical collar 18 which has a lateral face 20, an upper face 22 and a lower face 24.
  • the bottle is closed by a stopper made of a perforable material 26 which is engaged in the opening 16 of the bottle.
  • the periphery 28 of the stopper is applied against the upper face 22 of the flange and a metal crimping cap 30 ensures the tight fixing of the stopper to the opening 16 of the bottle 10.
  • the diameter D constituting the perforable central part of the cap is relatively small, this diameter depending on the dimensions of the bottle can range from 5 to 2 mm.
  • the syringe device 40 is essentially constituted by a part guide 42 and a conventional type syringe 44 provided with a needle 45.
  • the guide piece 42 which preferably has a symmetry of revolution about the axis XX 'has a first end 46 intended to be secured to the bottle 10, a second end 48 intended to receive and guide in translation the syringe 44 and an intermediate running part 50.
  • the first end 46 comprises a first guide surface 52 of internal diameter D'2 intended to cooperate with the cylindrical part 12 of the bottle, the latter having a diameter D2 slightly smaller than the diameter D'2.
  • the end 46 has a second guide revolution surface 54 intended to cooperate with the lateral face 20 of the flange 18 of the bottle, this guide surface having an internal diameter D'1 slightly greater than the diameter Dl of the flange 18. Between the guide surfaces 52 and 54, the end 46 of the guide piece comprises elastic clipping elements 58 serving to secure the end 46 of the guide piece 42 to the neck of the bottle 10. As best shown in the figures 2 and 4, the end 46 of the guide piece is connected to its main part by a part forming a plate 60 substantially orthogonal to the axis XX 'and forming an integral part of the guide piece.
  • This plate 60 is provided with an axial sleeve 62 which defines a center hole r rl 64 disposed along the axis XX 'of the guide piece.
  • the central opening.,. _4 is extended by a frustoconical part 66 facing the second end of the guide piece.
  • the end of the needle 45 is disposed inside the central orifice 64.
  • the lower face 60a of the plate 60 is preferably provided with an annular rib 70 surrounding the orifice 64 and projecting out of the face 60a. This secures the guide piece 42 on the bottle, the elastic tongues 58 cooperating with the underside 24 of the flange while the rib 70 is applied to the stopper.
  • the guide piece is automatically secured to the neck of the bottle due to the depression of the neck of the bottle in the end of the guide piece, without any 'No further action is necessary.
  • the tongues 58 due to their elasticity, are automatically activated.
  • FIG. 4b shows an alternative embodiment of the guide surface 52, and possibly of the guide surface 54. It makes it possible to achieve very good centering of the guide piece 42 on the bottle despite the dimensional tolerances of the bottle.
  • FIG. 2 shows, in dotted lines, another alternative embodiment of the guide piece.
  • the perforable membrane 72 is replaced by a film 73 (shown in the dotted figure), the periphery of which is tightly fixed on the guide piece 54.
  • This very thin waterproof film has primers in its center tear.
  • the bottle cap exerts pressure on the film 73 causing it to tear in its center.
  • the needle can freely cross it.
  • the internal face of the guide zone 52 can also be provided with a thread.
  • a removable cap with external filtering can then be aimed at the end of the guide piece.
  • the syringe 44 is guided in translation inside the current part of the guide part by an annular seal 78 which has on its external face 78a, preferably, three sealing ribs 80, 82 and 84 cooperating with the guide piece.
  • the internal face 78b of the seal 78 has a shoulder 86 cooperating with the body of the syringe 44. Consequently, the seal is driven by the syringe when the latter is pressed into the guide piece. On the other hand, the seal is free relative to the syringe when the latter is moved to extract it from the guide piece.
  • the end 48 of the guide piece has elastic strips 90 projecting inside the guide piece.
  • the ends of the elastic strips 90 are interposed between the ribs 82 and 84 ensuring a certain immobilization of the seal 78 relative to the guide piece.
  • a mechanical connection between the syringe and the guide part is effectively obtained by means of the seal 78 which, moreover, provides a dynamic seal between the guide part and the body of the syringe.
  • the guide piece 42 has on its external face a flange 92 which makes it possible to protect the fingers of the manipulators during the initial repositioning of the syringe inside the guide piece after use.
  • Figure 5 shows an alternative embodiment of the guide device. This variant consists only of another embodiment of the plate 60 and of the sleeve 62.
  • the plate element which is then referenced 60 ′ comprises a cylindrical sleeve 96 defining an axial bore 97 of large dimensions.
  • an insert 98 In this axial bore is engaged an insert 98.
  • This part 98 has a plate portion 100 provided with the rib 70 '.
  • the insert 98 also includes a part forming a sleeve 102 which is engaged in the cylindrical sleeve 96.
  • the sleeve 102 has a frustoconical end 104 and the central orifice 105, just as the sleeve 62 had a frustoconical end 66.
  • FIG. 6a illustrates the use of the syringe device.
  • the syringe device 40 is shown on the one hand and the bottle 10 with its perforable cap 26 on the other hand.
  • FIG. 6b shows the positioning of the syringe device 40 on the bottle 10.
  • the guide piece 42 is perfectly positioned relative to the bottle and therefore relative to the stopper thanks to the guide surfaces 52 and 54.
  • the clip tabs 58 cooperating with the flange 18 of the bottle, ensure that these two parts are joined together.
  • FIG. 6c shows the insertion of the syringe into the guide piece 42.
  • This insertion is controlled by the presence of the seal 78.
  • the needle 45 punctures the plug 26 in its center. It is then possible by actuating the plunger of the syringe to make the liquid that it contains penetrate into the bottle 10. After having mixed the two products, the mixture thus prepared is aspirated using the syringe. It suffices to extract the syringe 44 from the guide piece 42, the seal 78 remaining trapped in the guide piece thanks to the presence of the elastic tongues 90.
  • the translational guidance of the syringe in the guide part is achieved by the seal 78 which also provides sealing and therefore maintaining the sterility of the volume 76 containing the needle.
  • This double function could be obtained by providing that the syringe body 44 itself has annular ribs, for example three, offset axially which cooperate with the internal face of the current part of the guide piece.
  • the guiding in translation is ensured by the cooperation of guide surfaces internal to the guide piece with certain body portions 47 of the syringe.
  • the end of the body 47 on which the needle 45 is mounted has an end piece 120, a cylindrical portion of reduced diameter 122 and a cylindrical portion 124 of diameter greater than that of the current part of the syringe body.
  • the internal face 50a of the main part 50 of the guide part has a diameter slightly greater than the external diameter of the portion 124 of the syringe body, thus forming a first guide surface.
  • Inside the guide part are formed four radiating guide fins 126 whose edges 126a are arranged on a cylindrical surface of revolution whose diameter is slightly greater than that of the portion 122 of the syringe body. This defines a second guide surface. The distance between these two guide surfaces is sufficient to ensure very good guiding in translation of the syringe in the guide piece and therefore perfect centering of the needle 45 relative to the plug 26.
  • the upper end 126b of the fins 126 constitutes a stop for driving the syringe by cooperation with the large diameter portion 124 of the syringe body.
  • This stop ensures that, after insertion of the syringe into the guide piece, the tip of the needle 45 has passed through the stopper 26 of the bottle but that it penetrates very little into the bottle.
  • the purpose of these tabs 130 is to ensure the effective securing in translation of the syringe and of the guide piece when the syringe is fully inserted into the guide piece. This makes it more comfortable to manipulate the syringe plunger control rod to inject the liquid in the syringe and to draw the mixture out of the vial.
  • FIG. 7 another improvement has been shown which could also be implemented in the two preceding embodiments.
  • This improvement concerns the recovery of harmful gases which may possibly leave the bottle after the compounds have been mixed.
  • harmful gases or a residual fraction of liquid can penetrate in the guide piece and escapes into the surrounding air.
  • a piece 140 of a porous material such as a porous foam can be placed at the first end of the guide piece.
  • the gases possibly leaving the bottle are absorbed, trapped or blocked by the part 140.
  • the part 140 is crossed by the needle.
  • This filter also serves to compensate for pressures inside and outside the guide piece during movements of the syringe in the guide piece.
  • the syringe device according to the invention makes it possible not only to ensure rigorous coaxiality of the needle of the syringe and the vial, but also to rigorously position the guide piece relative to the vial in the direction of 'axis XX'. To control the insertion of the needle into the vial, it is therefore sufficient to control the insertion of the syringe into the guide piece. This result can be obtained automatically by providing a stop limiting the insertion of the syringe into the guide piece.

Landscapes

  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
EP95940304A 1994-11-14 1995-11-13 Spritzenvorrichtung befestigbar an einem fläschchen Expired - Lifetime EP0792135B1 (de)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
FR9413605 1994-11-14
FR9413605A FR2726767A1 (fr) 1994-11-14 1994-11-14 Dispositif de seringue fixable sur un flacon
FR9414973A FR2726768A1 (fr) 1994-11-14 1994-12-13 Dispositif de seringue fixable sur un flacon
FR9414973 1994-12-13
PCT/FR1995/001488 WO1996014820A1 (fr) 1994-11-14 1995-11-13 Dispositif de seringue fixable sur un flacon

Publications (2)

Publication Number Publication Date
EP0792135A1 true EP0792135A1 (de) 1997-09-03
EP0792135B1 EP0792135B1 (de) 2001-08-22

Family

ID=26231530

Family Applications (1)

Application Number Title Priority Date Filing Date
EP95940304A Expired - Lifetime EP0792135B1 (de) 1994-11-14 1995-11-13 Spritzenvorrichtung befestigbar an einem fläschchen

Country Status (9)

Country Link
US (1) US6280430B1 (de)
EP (1) EP0792135B1 (de)
JP (1) JP3987106B2 (de)
AU (1) AU4179896A (de)
BR (1) BR9509660A (de)
DE (1) DE69522340T2 (de)
ES (1) ES2162945T3 (de)
FR (1) FR2726768A1 (de)
WO (1) WO1996014820A1 (de)

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JPH10508525A (ja) 1998-08-25
BR9509660A (pt) 1997-10-28
FR2726768A1 (fr) 1996-05-15
EP0792135B1 (de) 2001-08-22
AU4179896A (en) 1996-06-06
DE69522340D1 (de) 2001-09-27
DE69522340T2 (de) 2002-06-13
JP3987106B2 (ja) 2007-10-03
WO1996014820A1 (fr) 1996-05-23
US6280430B1 (en) 2001-08-28
ES2162945T3 (es) 2002-01-16

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