EP1115361B1 - Verbindungsvorrichtung zwischen behälter und inhalt und gebrauchsfertige anordungen die eine solche vorrichtung enthalten - Google Patents

Verbindungsvorrichtung zwischen behälter und inhalt und gebrauchsfertige anordungen die eine solche vorrichtung enthalten Download PDF

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Publication number
EP1115361B1
EP1115361B1 EP99946225A EP99946225A EP1115361B1 EP 1115361 B1 EP1115361 B1 EP 1115361B1 EP 99946225 A EP99946225 A EP 99946225A EP 99946225 A EP99946225 A EP 99946225A EP 1115361 B1 EP1115361 B1 EP 1115361B1
Authority
EP
European Patent Office
Prior art keywords
plunger
lip
piston
bore
face
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.)
Expired - Lifetime
Application number
EP99946225A
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English (en)
French (fr)
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EP1115361A1 (de
Inventor
Antoine Aneas
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.)
Biodome SAS
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Biodome SAS
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Filing date
Publication date
Application filed by Biodome SAS filed Critical Biodome SAS
Publication of EP1115361A1 publication Critical patent/EP1115361A1/de
Application granted granted Critical
Publication of EP1115361B1 publication Critical patent/EP1115361B1/de
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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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
    • 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
    • A61J1/2089Containers or vials which are to be joined to each other in order to mix 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
    • A61J1/2006Piercing means
    • A61J1/2013Piercing means having two piercing ends
    • 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

Definitions

  • the invention relates to a device for connecting a closed container and container.
  • the invention also relates to a ready-to-use set including, among other things, a closed container and a connection device of the aforementioned type.
  • a component of a drug preparation such as for example its active ingredient
  • a plug made of relatively soft material for example in elastomer.
  • Liquid can be introduced into this container after perforation of the cap to dissolve or put in suspends the component contained in the container, in order to obtain a drug preparation in liquid form ready to be administered to the patient.
  • a perforation of the cap at an angle means that the visible section of the orifice, created in the plug by the passage of the hollow needle, is greater than the diameter outside of this needle, to the point that leaks may occur produce through the plug, around the hollow needle.
  • the container and the container to which it is associated are placed in a gravity flow position of the reconstituted drug from the container to the container, i.e. when the container is placed above the containing, it is possible that the drug preparation flows from the container to the piston and flows over the hands of user, which can be dangerous for some drugs or unpleasant for less aggressive drugs.
  • the device of the invention is characterized in that it includes a sealing lip, provided on an inner surface of the bore opposite the piston or on a surface of the piston, this lip being shaped to be sealed against the piston or against an internal surface of the bore in the piston transfer position.
  • a confinement volume is created around the hollow needle, between the plunger and the surface internal bore, this containment volume allowing retain leaking liquid, possibly outside the container through the opening formed in the cap by the hollow needle.
  • the base comprises a support wall against a external part of the stopper, the lip being shaped on a face of this wall facing the piston.
  • the lip is shaped on a front face of the piston oriented towards the plug.
  • the lip is shaped on an internal radial surface of the flange or on an external radial surface of the piston.
  • the lip has, in cross section, an asymmetrical profile inducing a preferred direction of deformation.
  • This aspect of the invention guarantees an adequate positioning of the lip when the piston is in transfer position, this adequate positioning guaranteeing the required seal.
  • the flange carries, on its internal radial face, a circular rod able to cooperate with a corresponding shoulder of the external radial surface of the piston to lock this piston in the transfer position.
  • the purpose of the piston lock is effect of precisely fixing the position of the piston, and thereby even, crushing or deformation of the sealing lip, which ensures tight contact between the lip and the surface with which it must cooperate.
  • the rod has an asymmetrical cross-section, the face of the rod oriented towards the outlet of the bore being less inclined by compared to the internal radial surface of the flange that the face of the rod facing the cap.
  • the rod does not interfere or slightly interferes with the sliding movement of the piston towards the plug, from its released position towards its transfer position, when it can oppose effectively to a movement of the piston in opposite direction.
  • the rush is advantageously capable of sealingly separating a volume annular, defined in the bore around the front part of the piston in transfer position, from the ambient atmosphere.
  • the rod then fulfills a sealing function which is added to that of the lip previously mentioned.
  • the invention also relates to a ready-to-use assembly, comprising a closed container containing a product, this container with a neck, the opening of which is closed by a plug of relatively soft material, and a device for connection as previously described, mounted on the container.
  • a ready-to-use assembly comprising a closed container containing a product, this container with a neck, the opening of which is closed by a plug of relatively soft material, and a device for connection as previously described, mounted on the container.
  • the device 1 has a double function. On the one hand it ensures the inviolability of a container 2, for example a glass bottle, containing a non- shown and previously closed or blocked. It allows other part of ensuring or establishing a tight connection between inside container 2 and inside another container 2 ', shown in phantom in Figure 3, this container may be a flexible bag containing a liquid intended for dissolve or suspend the product contained in the container 2, for example the active principle of a medicament.
  • the container 2 comprises a neck 3, the opening 3 a of which is closed, in a leaktight manner, by a plug 4, made of a relatively soft material, for example of elastomer and in particular rubber.
  • the neck 3 includes an external annular bead 3 b used for mounting and fixing a base 5.
  • the plug 4 comprises a cylindrical central part 4 a , adapted to a flexible and tight fitting inside the opening 3 a of the neck 3, and a flattened external part 4 b supported on the bead 3 b .
  • the base 5 is made in one piece from a relatively hard plastic material compared to the material constituting the plug 4. It comprises several attachment teeth 6 provided to be arranged around the bead 3 b of the neck 3, in the manner shown in Figure 2 and in accordance with the technical teaching of WO-A-97/10 156.
  • the base 5 comprises a wall 8 bearing on the part 4 b of the plug 4, this wall being provided with a central recess 8 a whose function will be explained in the following.
  • the wall 8 also carries two circular ribs 8 b and 8 c oriented towards the plug 4 and designed to penetrate the external part 4 b of the plug 4, so that they create a tight barrier between the wall 8 and the plug 4
  • the base 5 is extended by a flange 9, oriented opposite the teeth 6 relative to the wall 8 and whose internal radial surface 9 a defines a bore A of substantially circular section.
  • a piston 10 is provided to slide, inside of bore A, in a direction defined by the axis of symmetry X-X 'of this bore, axis which is also the axis of symmetry of the base 5 around which the teeth 6 are distributed.
  • the piston 10 includes a section 10 is generally perpendicular to the axis XX 'and a skirt 10 b shaped cylindrical sleeve centered on the axis XX'.
  • a hollow needle 11 carried by the section 10a of the piston 10 is centered on the axis X-X '.
  • the skirt 10b of the piston 10 carries a shoulder 10c while the collar 9 is provided with a peripheral internal projection 9b at the outlet of the bore A.
  • the piston 10 can be inserted inside bore A, by elastic deformation of the flange 9, in a position such that the shoulder 10 c is in contact with the projection 9 b , the piston 10 then being locked inside of the bore A. In this position, the needle 11 is released relative to the plug 4, that is to say does not perforate this plug.
  • a cap 12 is provided to be arranged around the assembly formed by the base 5 and the piston 10 and comprises a lower ring 13, capable of locking the teeth 6 of the base 5 around the neck 3, and a breakable part 14 intended to protect the piston 10 in the position of FIG. 2, this part breakable being connected to the ring 13 by a breaking line 15.
  • the face 8 d of the wall 8 oriented towards the piston 10 carries a lip 22 directed towards the front face 10 d of the section 10 a of the piston 10.
  • the lip 22 is in one piece with the wall 8, it even in one piece with the rest of the base 5 which is made of plastic material harder than the plug 4, but having a flexibility allowing the deformation of the lip 22.
  • the lip 22 is circular, that is to say extends over a circumference centered on the axis XX ′, so that, when it is in contact with the front face 10 d of the piston 10, it closes a volume V for confinement of a possible leak of liquid through the orifice 20, this volume being shown in gray in FIG. 4.
  • the lip 22 has an asymmetrical cross section in the shape of an inclined tooth.
  • the angle of inclination ⁇ of its external face 22 a relative to a normal N to the face 8 d is greater than the angle ⁇ of its internal face 22 b relative to a normal N 'to the face 8 d .
  • the edge 22 c of the lip 22 projects inwardly relative to the foot 22 d of the internal face 22 b .
  • the lip 22 exerts on the piston 10 a reaction force which increases when liquid is present in the volume V, this liquid exerting a pressure on the internal face 22 b of the lip 22, a pressure which tends to bring the lip 22 back into its configuration of FIG. 4A.
  • a ring 24 is provided on the internal radial surface 9 a of the flange 9, at a height such as relative to the wall 8 that it cooperates with the shoulder 10 c of the skirt 10 b to lock the piston 10 in the position transfer of figures 3 and 4.
  • the rod 24 extends advantageously over the entire circumference of the surface 9 and has, in cross section and as shown in Figure 4B, a face 24 a facing the opening of the bore A and a face 24 b directed towards the bottom of this bore, that is to say towards the plug 4 and the wall 8.
  • the angle of inclination ⁇ of the surface 24 a relative to the surface 9 a is of the order of 30 °, while the angle of inclination ⁇ of the surface 24 b relative to this same surface is around 60 °.
  • This asymmetrical shape of the ring 24 allows it not to oppose too strongly the driving movement of the piston 10 inside the bore A, because the face 24 a is slightly inclined relative to the axis X- X ', while it effectively locks the shoulder 10 c thanks to the significant inclination of its face 24 b .
  • the rod locking function 24 guarantees that adequate pressure is exerted by the piston 10 on the lip 22 in order to obtain a satisfactory seal.
  • the rod 24 As the rod 24 extends over the entire periphery of the surface 9 a, it also contributes to the sealing of the entire device 1 to the extent that the liquid, which successfully outside the volume V because of 'a leak at the level of the lip 22, would remain confined in the volume V' defined between the front face 10 d and the wall 8 outside the lip 22 and by the annular clearance J between the skirt 10 b and the surface 9 a , at the front of the piston 10.
  • the ring 24 therefore has a double locking and sealing function.
  • the device of this embodiment differs from the previous essentially in that the sealing lip 72 is carried by the front face 60 d of the piston 60 and intended to come into contact with the upper face 58 d of the partition 58 of the base 55.
  • the lip 72 therefore makes it possible to define a volume of containment V of a possible leak of liquid.
  • a ring 74 is also provided on the inner radial surface 59a of the flange 59 to lock the piston 60 in position relative to the base 55 and to form a second sealing barrier of a second closed volume V ' .
  • the piston 60 carries a shoulder 60 c capable of cooperating with the rod 74.
  • the front face 60 d of the piston 60 carries a groove 76 inside which the lip 72 is immobilized, which can be made of a material separate from that of the piston 72 and, in particular, in a more flexible material allowing increased deformation when the piston 60 is pressed against the wall 58 in order to improve the seal.
  • the lip 72 is immobilized in the groove 76 by all appropriate means and, in particular, by cooperation of forms and / or bonding.
  • a sealing lip 122 is provided on the radial surface internal 109 a of the flange 109 facing the external radial surface 110 e of the skirt 110 b of the piston 110 to delimit a confinement volume V.
  • a ring 124 is provided on the surface 109 a for immobilizing d a shoulder 110 c of the piston 110 relative to the base 105 in the transfer position. It also acts as a sealing barrier for a second closed volume V '.
  • the sealing lip could be carried by the outer surface 110 e of the skirt 110.
  • the skirts 22 and 122 could be constituted by elements attached to the base, according to a technique analogous to that evoked with reference to the embodiment of FIG. 5.
  • the lip carried by the piston in the mode of embodiment of Figure 5 could also be in one piece with this piston.
  • lips 72 and 122 have an asymmetrical profile, just like lip 22, which gives them direction of privileged deformation.
  • the rod 24, 74 or 124 is formed of discrete angular sectors, i.e. not joined, in which case it effectively performs its function of locking but does not participate in sealing the volume V '.
  • the immobilization piston 10, 60 or 110 thanks to rod 24, 74 or 124 guarantees constant positioning of needle 11 or equivalent, relative to container 2, so that the dead volume of container 2, i.e. the quantity of product contained in the container which cannot be recovered from made of the distance between the end of the needle 11 and the container neck, is constant from one device to another.
  • the quantity of product introduced into container 2 or equivalent before being closed by the corresponding cap can therefore be determined with precision, taking into account what constant dead volume.
  • the invention is applicable independently of the method of fixing the base 5 to the container 2 and, so general, that it can be used in any device connection comprising a piston, movable inside a bore of a base mounted on a container.

Claims (10)

  1. Verbindungsvorrichtung zwischen einem geschlossenen Gefäß (2) und einem Behälter (2'), wobei das Gefäß einen Hals (3) umfasst, dessen Öffnung (3a) durch einen Stöpsel (4) verschlossen ist, wobei die Verbindungsvorrichtung eine Fußfläche (5) umfasst, die an dem Gefäß (2) angebracht ist und sich durch einen Flansch (9) verlängert, der eine Innenbohrung (A) bildet, einen Kolben (10), der dazu ausgelegt ist, in der Innenbohrung zwischen einer bezüglich des Stöpsels freigesetzten Position und einer Überführungsposition zu gleiten, in der eine Hohlnadel (11), die von dem Kolben getragen ist, den Stöpsel (4) durchquert, dadurch gekennzeichnet, dass sie eine Dichtungslippe (22; 72; 122) umfasst, die an einer Innenfläche (8d; 109a) der Bohrung (A) dem Kolben (10; 110) gegenüberstehend oder auf einer Oberfläche (60d) des Kolbens (60) vorgesehen ist, wobei die Lippe so angepasst ist, dass sie in der Überführungsposition des Kolbens in dichter Anlage am Kolben (10; 110) oder an einer Innenfläche (58d) der Bohrung sein kann.
  2. Vorrichtung nach Anspruch 1, dadurch gekennzeichnet, dass die Fußfläche (5) eine Wand (8) zum Abstützen an einem Außenteil (4b) des Stöpsels (4) umfasst, wobei die Lippe (22) an einer Seite (8d) der Wand (8) angepasst ist, die zum Kolben (10) hin ausgerichtet ist.
  3. Vorrichtung nach Anspruch 1, dadurch gekennzeichnet, dass die Lippe (72) an einer Seite (60d), nämlich der Vorderseite des Kolbens (60) angepasst ist, die zum Stöpsel (4) hin ausgerichtet ist.
  4. Vorrichtung nach Anspruch 1, dadurch gekennzeichnet, dass die Lippe (122) an einer radialen Innenfläche (109a) des Flansches (109) oder an einer radialen Außenfläche (110e) des Kolbens (110) angepasst ist.
  5. Vorrichtung nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass die Lippe (22; 72; 122) im Querschnitt ein asymmetrisches Profil (α, β) aufweist, das eine bevorzugte Verformungsrichtung bewirkt.
  6. Vorrichtung nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass der Flansch (9; 59; 109) an einer radialen Innenseite (9a; 59a; 109a) einen Sprengring (24; 74; 124) trägt, der dazu ausgelegt ist, mit einer entsprechenden Schulter (10c; 60c; 110c) der radialen Außenfläche des Kolbens (10; 60; 110) zusammenzuwirken, um den Kolben in der Überführungsposition festzusetzen.
  7. Vorrichtung nach Anspruch 6, dadurch gekennzeichnet, dass der Sprengring (24; 74; 124) derart angeordnet ist, dass er den Kolben (10; 60; 110) in einer Position der dichten Anlage der Lippe (22; 72; 122) am Kolben (10; 110) oder an einer Innenfläche (58d) der Bohrung (A) festsetzt.
  8. Vorrichtung nach einem der Ansprüche 6 oder 7, dadurch gekennzeichnet, dass der Sprengring (24; 74; 124) einen asymmetrischen Querschnitt aufweist, wobei die Seite (24a) des Sprengrings, die zum Ausgang (9b) der Bohrung (A) hin weist, bezüglich der radialen Innenfläche (9a) des Flansches (9) weniger geneigt (γ, δ) ist als die Seite (24b) des Sprengrings, die zum Stöpsel hin weist.
  9. Vorrichtung nach einem der Ansprüche 6 bis 8, dadurch gekennzeichnet, dass der Sprengring (24; 74; 124) dazu ausgelegt ist, einen ringförmigen Hohlraum (V'), der in der Überführungsposition in der Bohrung (A) um den vorderen Teil des Kolbens (10; 60; 110) gebildet ist, bezüglich der Umgebungsatmosphäre auf dichte Weise abzutrennen.
  10. Gebrauchsfertige Einheit, die ein geschlossenes, ein Produkt enthaltendes Gefäß (2) umfasst, wobei das Gefäß einen Hals (3), dessen Öffnung (3a) durch einen Stöpsel (4) verschlossen ist, und eine am Gefäß angebrachte Verbindungsvorrichtung (5-24; 60-76; 109-124) nach einem der Ansprüche 1 bis 9 umfasst.
EP99946225A 1998-09-24 1999-09-23 Verbindungsvorrichtung zwischen behälter und inhalt und gebrauchsfertige anordungen die eine solche vorrichtung enthalten Expired - Lifetime EP1115361B1 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
FR9812120 1998-09-24
FR9812120A FR2783808B1 (fr) 1998-09-24 1998-09-24 Dispositif de connexion entre un recipient et un contenant et ensemble pret a l'emploi comprenant un tel dispositif
PCT/FR1999/002268 WO2000016730A1 (fr) 1998-09-24 1999-09-23 Dispositif de connexion entre un recipient et un contenant et ensemble pret a l'emploi comprenant un tel dispositif

Publications (2)

Publication Number Publication Date
EP1115361A1 EP1115361A1 (de) 2001-07-18
EP1115361B1 true EP1115361B1 (de) 2002-11-20

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EP99946225A Expired - Lifetime EP1115361B1 (de) 1998-09-24 1999-09-23 Verbindungsvorrichtung zwischen behälter und inhalt und gebrauchsfertige anordungen die eine solche vorrichtung enthalten

Country Status (18)

Country Link
US (1) US6537263B1 (de)
EP (1) EP1115361B1 (de)
JP (1) JP3983978B2 (de)
KR (1) KR100591213B1 (de)
CN (1) CN1178638C (de)
AT (1) ATE227966T1 (de)
AU (1) AU749364C (de)
BR (1) BR9913901A (de)
CA (1) CA2339897C (de)
DE (1) DE69904064T2 (de)
DK (1) DK1115361T3 (de)
ES (1) ES2188238T3 (de)
FR (1) FR2783808B1 (de)
HK (1) HK1039446A1 (de)
PT (1) PT1115361E (de)
RU (1) RU2214216C2 (de)
TR (1) TR200101557T2 (de)
WO (1) WO2000016730A1 (de)

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US6537263B1 (en) 2003-03-25
AU749364C (en) 2003-01-23
EP1115361A1 (de) 2001-07-18
ES2188238T3 (es) 2003-06-16
HK1039446A1 (zh) 2002-08-02
DE69904064D1 (de) 2003-01-02
FR2783808A1 (fr) 2000-03-31
DK1115361T3 (da) 2003-03-10
WO2000016730A1 (fr) 2000-03-30
CA2339897A1 (fr) 2000-03-30
JP2002526202A (ja) 2002-08-20
JP3983978B2 (ja) 2007-09-26
PT1115361E (pt) 2003-02-28
FR2783808B1 (fr) 2000-12-08
CA2339897C (en) 2008-07-08
CN1314803A (zh) 2001-09-26
AU5867199A (en) 2000-04-10
KR100591213B1 (ko) 2006-06-22
BR9913901A (pt) 2001-07-03
RU2214216C2 (ru) 2003-10-20
DE69904064T2 (de) 2003-10-09
KR20010075324A (ko) 2001-08-09
AU749364B2 (en) 2002-06-27
ATE227966T1 (de) 2002-12-15
TR200101557T2 (tr) 2001-10-22

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