EP0904763B1 - Verbinder mit Verriegelungsring für eine Phiole - Google Patents

Verbinder mit Verriegelungsring für eine Phiole Download PDF

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Publication number
EP0904763B1
EP0904763B1 EP19980307517 EP98307517A EP0904763B1 EP 0904763 B1 EP0904763 B1 EP 0904763B1 EP 19980307517 EP19980307517 EP 19980307517 EP 98307517 A EP98307517 A EP 98307517A EP 0904763 B1 EP0904763 B1 EP 0904763B1
Authority
EP
European Patent Office
Prior art keywords
collar
vial
connector assembly
locking ring
stopper
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
EP19980307517
Other languages
English (en)
French (fr)
Other versions
EP0904763A2 (de
EP0904763A3 (de
Inventor
Hubert Jansen
Jean-Claude Thibault
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.)
Becton Dickinson France SA
Original Assignee
Becton Dickinson France SA
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Filing date
Publication date
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Publication of EP0904763A2 publication Critical patent/EP0904763A2/de
Publication of EP0904763A3 publication Critical patent/EP0904763A3/de
Application granted granted Critical
Publication of EP0904763B1 publication Critical patent/EP0904763B1/de
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Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2089—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
    • A61J1/14—Details; Accessories therefor
    • A61J1/1406—Septums, pierceable membranes
    • 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
    • A61J1/2048—Connecting means
    • A61J1/2055—Connecting means having gripping means

Definitions

  • the invention relates to a connector assembly for a vial, and more particularly, to a locking ring connector assembly for a vial which minimizes the number of components in the connector assembly and which reduces the number of microbial barriers necessary to safeguard sterility of the system.
  • a dry or powdered form In the art, it is generally known that to reduce inventory space or to increase the shelf life of certain drugs, or both, it is advantageous to reduce these drugs to a dry or powdered form.
  • These dry or powdered drugs are normally stored in a sealed container such as a vial, and reconstituted into liquid form with an appropriate diluent or solvent solution prior to administration to a patient.
  • the vials typically formed of glass or plastic materials, include an elastomeric stopper sealing the open end of the vial.
  • the stopper includes a portion inserted into the neck of the vial as well as a planar portion which rests on top of the vial, against the vial rim.
  • the planar portion is normally tightly affixed to the vial rim with an aluminum crimp cap.
  • the crimp cap readily adapts itself any differing dimension or tolerances which may exist between the stopper and the vial. The result is that the crimp cap evenly distributes sealing forces between the stopper and the vial.
  • the vial/stopper/aluminum crimp cap solution safeguards the sterility of the drug contained within the vial over suitably long storage periods and prescribed conditions.
  • the sizes and dimensions of the various vials and stopper components may be configured to given standards, such as given ISO standards.
  • One way to reconstitute the drug stored in the vial is to introduce the solvent or diluent from a syringe by piercing the stopper sealing the vial.
  • the art has recognized ways to transform the standard sealed vial into a system suitable for permitting safe, effective reconstitution of the drug contained within the vial.
  • a fluid transfer assembly is connected to the neck of the vial.
  • the fluid transfer system includes structure for connecting the vial to a source of diluent, such as diluent held in bottles, bags or syringes.
  • the transfer assembly is thereafter activated to permit the flow of fluid into the vial to from the source of diluent, thereby reconstituting the drug.
  • the systems are such that the standard vial stopper is eliminated in favor of fluid transfer assembly having a rubber stopper which is inserted into the neck of the vial, without the need for a planar portion which rests against the rim of the vial. This stopper remains within the neck until such time as reconstitution of the drug is desired.
  • the transfer assembly is activated, the stopper is urged towards the interior of the vial to open the neck, thereby permitting fluid to flow through the transfer assembly and into the vial body.
  • Examples of such approaches include the MONOVIAL® line of drug delivery devices manufactured and sold by Becton Dickinson Pharmaceutical Systems of Le Pont de Claix, France and exemplified, for instance, by US Patent No. 5,358,501.
  • This rubber piercing fluid transfer assembly is activated by an end user when it is desired to reconstitute the drug held in the vial.
  • the transfer assembly disclosed in this patent application features a fairly rigid, outermost plastic locking ring which, in theory, should lock the plastic transfer assembly firmly against the planar portion of the stopper and, hence, sealing this portion stopper against the vial rim.
  • the malleable nature of the aluminum crimp cap takes into account differences in tolerances.
  • a connector assembly for a vial said vial including a neck, an open end at the proximal end of the neck, a rim bounding the open end, and a stopper obturating the open end of the vial, the rim having a side portion and an underside portion facing away from the open proximal end of the vial, the stopper having a planar portion covering the rim, the connector assembly comprising:
  • a connector assembly in accordance with the present invention is designed to be employed with a standard vial and stopper so as to be able to be processed by a pharmaceutical manufacturer with standard processing equipment.
  • the connector assembly is fully able to account for dimensional variances or tolerance variances in the vial or stopper components or in the components forming the connector assembly itself, so as to ensure good microbiological barrier characteristics.
  • the connector assembly features a protective cap for covering the open end of the vial neck.
  • the cap includes an open proximal end, a closed distal end, and a shield wall formed therebetween.
  • a collar is provided adjacent the open proximal end of the cap.
  • the collar can be molded with the cap, or it can be separately manufactured and thereafter affixed to the cap.
  • the collar features a proximal end, a distal end, and a sidewall therebetween.
  • One or more rib elements are provided on an interior portion of the collar adjacent the distal end, and the ribs designed to form a tight seal against the stopper as the collar is positioned against the stopper.
  • Interior portions of the collar can be configured to mate with a vial access device provided to pierce the stopper.
  • a locking ring is provided between the collar and the rim of the vial.
  • the locking ring features a proximal end, a distal end, and an annular section therebetween.
  • An internally projecting ridge is provided adjacent the proximal end of the locking ring.
  • a cooperative locking structure is provided between the collar and the locking ring to retain the locking ring in a locked position respective of the collar.
  • the cooperative locking structure can be formed as ratcheting teeth provided between the side wall of the collar and the annulus section of the ring.
  • the cooperative locking structure can be formed as cooperating threads.
  • the locking ring may also feature a skirt portion located proximally of the ridge, which serves to engage a shoulder portion of the vial located proximally of the rim.
  • the connector assembly can be shipped to a pharmaceutical manufacturer such that the locking ring is retained in an unlocked position respective of the collar.
  • the connector assembly can be attached to the vial.
  • the connector assembly is transferred from a first position, whereby the locking ring is placed around the rim and the cap spaced from the stopper, to a second position, whereby the internally projecting ridge of the locking ring is thrust about the outside surface of the rim and against an underside portion of the rim.
  • the ribs provided in the interior of the collar are thrust into sealing relation with the stopper, to form a microbiological barrier safeguarding the sterility of the vial access device contained by the connector assembly.
  • the locking ring may be urged distally of the collar towards a locked position respective of the collar.
  • the locking ridge of the ring is thus urged against the underside portion of the rim, ensuring that the collar is securely locked to the vial.
  • the cap and collar can be manufactured in such a manner such that the cap is removable from the collar by a twisting action, permitting a user a convenient way to engage the vial access device held by the connector assembly.
  • the cap can be formed with the collar, with a frangible connection formed from a material-such as a thermoplastic elastomer--that is different from the material forming the cap and collar itself, such as polypropylene or polyethylene.
  • the user may simply twist the cap such that the frangible connection shears, allowing the user to remove the cap to expose the vial access device.
  • One way to achieve this construction is through a co-injection process. All in all, the minimization of the number of components forming the connector assembly results in a concomitant reduction in the number of biological barriers necessary to safeguard the sterility of the vial access device as well as the medicament contained within the vial.
  • proximal denotes a distance closest to rim 14 of vial 10
  • distal denotes a distance furthest from the rim of the vial
  • FIGS. 1 and 2 illustrate a first embodiment 30 of a connector assembly for a vial 10 in accordance with the present invention.
  • Vial 10 is characterized by a bottom wall 11, a sidewall 13, a neck 12 and an annular rim 14.
  • a shoulder 21 is located between rim 14 and sidewall 13.
  • Annular rim 14 includes an underside portion 18, a side portion 20, and a top surface 16.
  • a stopper 22 is typically employed to obturate an open end 17 associated with the vial Stopper 22 features a planar portion 24 covering top surface 16 of the rim, and a plug portion 23 obturating the inside surface 19 of neck 12.
  • Vial 10 is typically filled with a desired medicament, such as a dry drug or a lyophilized drug, and thereafter affixed with stopper 22, in a cleanroom environment.
  • a desired medicament such as a dry drug or a lyophilized drug
  • stopper 22 in a cleanroom environment.
  • a drawback in the art is ensuring that proper sealing forces exist between stopper 22 and vial 10. It would also be advantageous to incorporate a solution to this problem in a vial connector assembly that is easily processed by the pharmaceutical manufacturer and which, desirably, can be fully processed in the cleanroom environment where medicaments are processed, introduced into the vial, and stoppered within the vial.
  • Connector assembly 30 is formed of three principal components, namely, a cap 32, a collar 42, and a locking ring 60.
  • Cap 32 is characterized by a closed distal end 34, an open proximal end 36, and a shield wall 38 therebetween. Cap 32 is provided adjacent collar 42. Cap 32 and collar 42 can be formed together, such as by a co-injection process, or they can be separately formed and joined together by mechanical means, welding, adhesives, or the like. In a preferred construction, cap 32 and collar 42 are formed together and connected by a frangible section 100, as will be hereinafter discussed.
  • Collar 42 is designed to mate with rim 14 of the vial. Collar 42 is located adjacent open proximal end 36 of the cap. Collar 42 includes an upstanding tubular section 37 defining an interior portion 35. Interior portion 35 serves to engage and otherwise enclose a vial access device 80, as will be more fully explained hereinbelow. Adjacent tubular section 37 there is provided a vial attachment section 39. Vial attachment section 39 of the collar displays a distal end 44, an open proximal end 46, and a sidewall 48 therebetween. One or more sealing ribs 40 are provided, on an interior portion of vial attachment section 39, adjacent distal end 44. Ribs 40 can take any shape appropriate to their sealing function, such as rounded, peaked, square, or other geometries.
  • collar 42 is disposed between a first position, wherein sealing ribs 40 are spaced from planar portion 24 of stopper 22 ( Figure 3) to a second position, wherein sealing ribs 40 are engaged against the planar portion in sealing contact with it ( Figures 4 and 5).
  • a locking ring 60 is disposed between rim 14 and collar 32. Locking ring 60 serves to lock the collar to the rim in the second position. Locking ring 60 includes a proximal end 64, a distal end 62, and an annulus section 66 therebetween. Annulus section 66 preferably displays an inside diameter "G" at least equal to, if not slightly greater than, outside diameter "F” of rim 14 ( Figures 2 and 3). Locking ring 60 includes an internally projecting ridge 70 adjacent proximal end 64. A distally facing locking surface 72 is provided on ridge 70. Locking surface 72 is designed to mate with underside portion 18 of rim 14. Locking surface 72 displays an inner diameter "H” which is smaller than outside diameter "F” of rim 14 ( Figures 2 and 3).
  • locking structure 68a and 68b can take the form of cooperating ratcheting teeth formed about the respective circumferences of sidewall 48 of the collar (68b) and annulus section 66 of the ring (68a).
  • the locking structure can be configured as cooperating threads provided between collar 42 and locking ring 60.
  • locking structure 68b is preferably placed adjacent proximal end 46 of the collar and locking structure 68a placed adjacent distal end 62 of the ring.
  • Connector assembly 30 typically encloses a vial access device 80.
  • Vial access device 80 is structured to pierce stopper 22 so as to gain access to the medicament held by vial 10. While not limited in scope, in general vial access device 80 may feature a body 82 in frictional engagement with an interior surface 35 associated with tubular section 37 of the collar. A distally facing piercing element 84 is mounted to the body. A connector end 86, attached in fluid communication to piercing element 84, is provided to mount the vial access device to an external component such as a syringe, a rigid bottle, a flexible bottle, or the like.
  • piercing element 84 can take various configurations, such as a pointed metallic or plastic needle, a spike, or any pointed structure serving to pierce stopper 22.
  • connector end 86 can be configured as a spike (here illustrated), a needle, as a luer connector, or any other desirable configuration to mate with the various external components, such as rigid fluid bottles, luer lock or luer slip syringes, flexible fluid bags, or the like, with which an end user will want to employ with the connector assembly.
  • a protective shield 85 may be placed about connector end 86, particularly desirable when the connector end is configured as a needle.
  • the pharmaceutical customer would process or otherwise fill a desired medicament in vial 10, thereafter applying stopper 22 to the vial neck. Both of these operations would occur in a cleanroom environment.
  • the component manufacturer would normally supply connector assembly 30 to the pharmaceutical manufacturer in a pre-assembled sterile state, ready to apply to an already stoppered vial.
  • locking ring 60 is positioned respective of collar 42 such that cooperative locking structure 68a, 68b define an unlocked position. That is to say, proximal end 64 of the ring is displaced proximally way from proximal end 46 of the collar, such that the distance "K" between locking surface 72 of ridge 70 and distal end 44 of the collar is at least equal to, if not slightly greater than, the combined thicknesses "B" and "C” of rim 14 and planar portion 24 of the stopper, respectively.
  • Locking structure 68a, 68b retains the ring to the collar.
  • Vial access device 80 is enclosed inside cap 32 and collar 42.
  • Pre-assembled connector assembly 30 is thus placed over vial 10 directly in the cleanroom, with open proximal end 64 of the ring passing around side portion 20 of rim 14.
  • Figure 4 illustrates placement of the connector assembly towards its second position relative to vial 10.
  • ridge 70 has been urged over outside portion 20 of the rim, with locking surface 72 facing underside portion 18 of the rim.
  • distance "K” is still at least equal to, if not slightly greater than, the combined thicknesses "B" and "C” of the rim and planar portion of the stopper.
  • ribs 40 provided on collar 42 have descended upon stopper 22 such that they are engaged in sealing contact with planar portion 24.
  • ring 60 continues to be located in an unlocked position relative to collar 42 during this stage.
  • the jig will exert a distally directed force on ring 60 and a proximally directed force upon collar 42, effectively "squeezing" ridge 70 and distal end 44 of the collar towards one another until locking surface 72 of the ridge meets underside portion 18 of the rim, and ribs 40 of collar 42 tightly bite into planar portion 24 of stopper 22.
  • a compressive force thus applied between the planar portion the stopper and top surface 16 of vial rim 14.
  • sealing ribs 40 are urged to tightly bite into planar portion 24 of the stopper.
  • Vial access device 80 is thus secured in microbiological isolation within connectior assembly 30, and stopper 22 tightly sealed to vial 10 so as to isolate the drug held by the vial.
  • Locking structure 68a, 68b between the locking ring and the collar will retain the two in the locked position.
  • Connector assembly 30 is now securely affixed to the vial, and the filled vial may now be removed from the cleanroom and shipped to the end user as desired.
  • the squeezing action between ridge 70 and distal end 44 of the collar is enhanced by the "ratcheting" effect created by employing cooperative locking structure configured, for instance, as the ratcheting teeth shown in Figure 6a. That is to say, by employing ratcheting teeth for the cooperative locking structure, connector assembly 30 can more flexibly compensate for any tolerance or dimensional variations in the rim or the stopper, to better ensure that equal sealing forces will be exerted by the collar across the surface of the stopper. This contributes, of course, to a proper seal both between the stopper and the vial rim and between the collar and the stopper. The same benefits can be realized by the threaded cooperative locking structure illustrated in Figure 6.
  • cap 32 is removed from collar 42 so as to expose vial access device 80
  • Figures 8A and 813 illustrate forming cap 32 and collar 42 together and providing a frangible section 100 between them.
  • Frangible section 100 permits a user to apply a twisting force to cap 32 so as to remove the cap from the collar to expose vial access device 80.
  • Cap 32 and collar 42 may be formed together by a co-injection process, wherein a material having a low shear resistance is employed for frangible section 100, and a material having a higher shear resistance is employed for the rest of the cap and the collar.
  • frangible section 100 can be formed by employing various thermoplastic elastomers (“TPE”) displaying low shear resistance, and which display good adhesion properties to the material chosen for the rest of the cap, which typically can be polypropylene or polyethylene.
  • TPE thermoplastic elastomers
  • frangible section 100 can be configured as a series of TPE pockets, or "teeth", 110 that are molded into an interior section 112 defined between cap 32 and collar 42. Teeth 110 are interspersed with intervening sections 116 of the section 100, the intervening sections formed from the more shear resistant material that makes up the remainder of cap 32 or collar 42.
  • the resulting frangible section 100 allows a user to exert a moderate twisting force "TF" against the cap to remove it.
  • the presence of intervening sections 116 strengthen the frangible section against inadvertent removal of the cap caused, for instance, by jostling during shipment, inadvertent opening by an end user, or the like.
  • frangible section 100 can be formed as a solid section 120 of TPE material across interior section 112.
  • cap 32 and collar 42 as a single unit, an additional, potential area for microbiological contamination--the juncture between the cap and the collar--is eliminated, leading to a concomitant reduction in the number of microbiological barriers needed.
  • cap 32 and collar 42 can be formed separately and attached by various means, such as by welding, adhesives, or the like. That will safeguard integrity of the connection between the cap and the collar, but that will provide a reasonable twisting force TF to permit a user to remove the cap.
  • the cap and the collar can be formed from suitable materials, such as polyethylene or polypropylene.
  • cap 32 is removed from collar 42, and vial access device 80 exposed.
  • An external component is attached to connector end 86, and a proximally directed force applied.
  • Piercing element 84 is urged through stopper 22 and into communication with the interior of the vial.
  • Body 82 is slidably disposed with respect to interior surface 35 of collar 42.
  • the engagement between body 82 and interior surface 35 can be by frictional engagement, via mechanical engagement such as by threaded engagement or by a lot and follower arrangement, or by other arrangements within the realm of the skilled artisan.
  • body 82 can be retained against inadvertent removal from interior surface 35 by providing a stop 88 adjacent a proximal end of body 82 that is arrested by a shoulder 89 inside collar 42.
  • Figure 7 illustrates a second embodiment 230 of a connector assembly in accordance with the present invention.
  • like components are described as for embodiment 30 of Figures 1-5 above, except that a prefix "2" is supplied to the numerical designation for those components. Accordingly, detailed description of these like components need not be repeated for embodiment 230.
  • connector assembly 230 is substantially as before described, except that a skirt portion 290 is provided on locking ring 260 in an area proximal to internally projecting ridge 270.
  • Skirt 290 displays a length "L” that is at least equal to distance "M” measured between underside portion 218 of the rim and shoulder 221 of the vial.
  • the purpose of skirt 290 is to provide a way to more automatically engage locking ring 260 in locked position with collar 242 during placement of the connector assembly to the vial.
  • proximal end 291 of the skirt will eventually make contact with shoulder 221 of the vial.
  • skirt 290 will be arrested from further proximal movement respective of rim 214 by a distally directed force exerted by shoulder 221 upon skirt 290.
  • proximal motion of collar 242 and ring 260 thus, will result in locking ring 260 reversing direction respective of collar 242 (because of the distally directed force exerted by the vial upon the skirt), such that internally projecting ridge 270 will be thrust against underside portion 218 of the rim.
  • connector assembly 230 is supplied to a pharmaceutical manufacturer in a pre-assembled, sterile state, with vial access 280 engaged within cap 232 and collar 242.
  • a frangible section here again denoted by numeral 100
  • cap 232 and collar 242 can be incorporated between cap 232 and collar 242.
  • the various components can be constructed from materials standard in the art.
  • the cap, the collar, and the ring can be injection molded from various thermoplastics (the construction of the frangible section having been already explained).
  • the vial access device can be made from various medical grade plastics, medical grade stainless steels, combinations of these materials, or the like.
  • Various rubbers or elastomers can be chosen for the stopper, and the vial can be made from suitable glass or plastics materials adapted to the drug held therein.
  • various tamper evidence means such as heat shrunk plastic strips, can be incorporated between the vial and the collar.

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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)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Closures For Containers (AREA)

Claims (8)

  1. Verbinderanordnung (30) für eine Phiole (10), wobei die Phiole (10) umfasst: einen Hals (12); ein offenes Ende am proximalen Ende des Halses (12); einen Kranz (14), der das offene Ende begrenzt; und einen Stopfen (22), der das offene Ende der Phiole (10) verschließt, wobei der Kranz (14) einen Seitenabschnitt (20) und einen Unterseitenabschnitt (18) aufweist, der vom offenen proximalen Ende der Phiole (10) weg liegt, wobei der Stopfen (22) einen ebenen Abschnitt (24) aufweist, der den Kranz (14) bedeckt, wobei die Verbinderanordnung (30) aufweist:
    eine Schutzkappe (32) für das Abdecken des offenen Endes der Phiole (10), wobei die Kappe (32) ein offenes proximales Ende, ein geschlossenes distales Ende und eine dazwischen gebildete Schutzwand aufweist;
    einen Bund (42), der benachbart dem offenen proximalen Ende der Schutzkappe (32) vorhanden ist, wobei der Bund (42) ein proximales Ende, ein distales Ende und eine Seitenwand dazwischen definiert, wobei der Bund (42) zwischen einer ersten Position, bei der das distale Ende des Bundes (42) vom Stopfen (22) beabstandet ist, und einer zweiten Position beweglich ist, bei der das distale Ende des Bundes (42) den ebenen Abschnitt (24) des Stopfens (22) berührt;
    einen Verriegelungsring (60), der zwischen dem Bund (42) und dem Kranz (14) der Phiole (10) vorhanden ist, wobei der Verriegelungsring (60) ein proximales Ende (64), ein distales Ende (62) und einen Ringabschnitt (66) dazwischen aufweist, wobei eine innen vorstehende Wulst (70) am proximalen Ende (64) des Verriegelungsringes (60) vorhanden ist; und
    eine zusammenwirkende Verriegelungskonstruktion (68b, 68a), die zwischen dem Bund (42) und dem Vernegelungsring (60) vorhanden ist, um den Verriegelungsring (60) in einer verriegelten Position entsprechend dem Bund (42) zu halten;
       dadurch gekennzeichnet, dass:
    die zusammenwirkende Verriegelungskonstruktion einen oder mehrere zusammenwirkende Sperrzähne (68b, 68a) aufweist, die zwischen dem Bund (42) und dem Verriegelungsring (60) vorhanden sind,
    so dass nach dem Anordnen des Bundes (42) in der zweiten Position der Verriegelungsring (60) in die verriegelte Position getrieben wird, so dass die Wulst (70) mit dem Unterseitenabschnitt (18) des Kranzes (14) in Berührung kommt, um den Bund (42) in der zweiten Position zu sichern.
  2. Verbinderanordnung nach Anspruch 1, bei der die Phiole (210) einen Vorsprungabschnitt (221) umfasst und der Verriegelungsring (260) einen Randabschnitt (290) umfasst, der proximal von der Wulst (270) angeordnet ist, wodurch, während der Bund (232) in Richtung der zweiten Position getrieben wird, der Randabschnitt mit dem Vorsprung (221) der Phiole in Berührung kommt, um den Verriegelungsring (260) in Richtung der verriegelten Position zu drücken.
  3. Verbinderanordnung nach Anspruch 1, die außerdem eine Phiolenzugangsvorrichtung (80) mit einem Durchstoßelement (84) für das Durchstoßen des Stopfens (22) aufweist.
  4. Verbinderanordnung nach Anspruch 3, bei der die Phiolenzugangsvorrichtung (80) mit einem Innenabschnitt (35) des Bundes (42) in Berührung kommt.
  5. Verbinderanordnung nach Anspruch 1, die außerdem eine Phiolenzugangsvorrichtung aufweist, die aufweist: ein Gehäuse, das mit einem Innenabschnitt des Bundes in Berührung kommen kann; ein Durchstoßelement für das Durchstoßen des Stopfens auf der Phiole; und ein Verbinderende in Fluidverbindung mit dem Durchstoßelement, um die Phiolenzugangsvornchtung mit einem äußeren Teil zu verbinden.
  6. Verbinderanordnung nach Anspruch 1, bei der die Kappe (32) aus einem Material geformt wird, das aus der Gruppe ausgewählt wird, die Polypropylen oder Polyethylen aufweist, und bei der die Kappe (32) und der Bund (42) einen zerbrechlichen Abschnitt (100) zwischen sich umfassen, wobei der zerbrechliche Abschnitt (100) aus einem thermoplastischen Elastomer gebildet wird.
  7. Verbinderanordnung nach Anspruch 3 oder 5, bei der das Verbinderende der Phiolenzugangsvorrichtung (80) aus der Gruppe ausgewählt wird, die einen Luer-Verbinder, einen Nagel oder eine Nadel aufweist.
  8. Verbinderanordnung nach Anspruch 1, bei der die Kappe (32) am Bund (42) durch Schweißen, Klebstoffe oder mechanische Mittel befestigt wird oder der Bund (42) zusammenhängend mit der Kappe (32) gebildet wird.
EP19980307517 1997-09-25 1998-09-16 Verbinder mit Verriegelungsring für eine Phiole Expired - Lifetime EP0904763B1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US93629097A 1997-09-25 1997-09-25
US936290 1997-09-25

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EP0904763A2 EP0904763A2 (de) 1999-03-31
EP0904763A3 EP0904763A3 (de) 1999-12-15
EP0904763B1 true EP0904763B1 (de) 2005-12-14

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Families Citing this family (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE10142450C1 (de) * 2001-08-31 2003-06-18 Aventis Behring Gmbh Vorrichtung zum Zusammenführen von Komponenten unter sterilen Bedingungen
EP1323403B1 (de) 2001-12-17 2006-04-19 Bristol-Myers Squibb Company Transfervorrichtung sowie System mit einer Kappenanordnung, einem Behälter und der Transfervorrichtung
US7772565B2 (en) 2005-08-12 2010-08-10 Mallinckrodt Inc. Radiation-shielding assembly having container location feature
FR2894463B1 (fr) * 2005-12-14 2008-09-19 Biocorp Rech Et Dev Sa Dispositif de connexion fixe sur un recipient
CN2885751Y (zh) * 2006-04-20 2007-04-04 叶仲伦 保鲜瓶盖
EP2540276B1 (de) * 2006-05-25 2016-03-16 Bayer Healthcare LLC Verfahren zur Herstellung einer Rekonstitutionsvorrichtung
DE102009004828B4 (de) 2009-01-13 2010-12-09 Lts Lohmann Therapie-Systeme Ag Injektor mit verdrängbarem Stopfenteil
EP2347750A1 (de) * 2010-01-26 2011-07-27 Fresenius Kabi Deutschland GmbH Konnektor für medizinischen Wirkstoff enthaltende Behälter
WO2012132829A1 (ja) * 2011-03-25 2012-10-04 テルモ株式会社 両頭針及び混合器具
SG11201404436XA (en) 2012-02-02 2014-08-28 Becton Dickinson Holdings Pte Ltd Adaptor for coupling with a medical container
SG192310A1 (en) 2012-02-02 2013-08-30 Becton Dickinson Holdings Pte Ltd Adaptor for coupling to a medical container
SG192312A1 (en) 2012-02-02 2013-08-30 Becton Dickinson Holdings Pte Ltd Adaptor for coupling to a medical container
JP1526207S (de) 2013-08-05 2015-06-15
EP3324915A1 (de) * 2015-07-20 2018-05-30 Medimop Medical Projects Ltd. Transfervorrichtungen für flüssige arzneimittelt mit flexiblen phiolenhalteelementen für eine konfigurationsposition
WO2017096238A1 (en) * 2015-12-03 2017-06-08 Drexel University Medical fluid delivery system
WO2017179071A1 (en) * 2016-04-15 2017-10-19 Atul Sardana An integrated packing, reconstitution and delivery device for oral vaccines and drugs containing multiple components
IL249408A0 (en) 2016-12-06 2017-03-30 Medimop Medical Projects Ltd A device for transporting fluids for use with an infusion fluid container and a hand tool similar to a plunger to release a vial from it
US10543962B2 (en) * 2017-06-23 2020-01-28 Elc Management Llc Container and cap assembly
IL254802A0 (en) 2017-09-29 2017-12-31 Medimop Medical Projects Ltd A device with two vial adapters includes two identical perforated vial adapters

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE69003805T2 (de) 1989-11-13 1994-05-19 Becton Dickinson France Vorratsbehälter für einen bestandteil einer medikamentenlösung.
JP2605345Y2 (ja) * 1992-05-01 2000-07-10 株式会社大塚製薬工場 薬剤容器
FR2738550B1 (fr) 1995-09-11 1997-11-07 Biodome Dispositif d'obturation d'un recipient lui-meme ferme, ensemble pour dispenser un produit comprenant un tel recipient et un tel dispositif d'obturation

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Publication number Publication date
EP0904763A2 (de) 1999-03-31
JPH11152161A (ja) 1999-06-08
DE69832766D1 (de) 2006-01-19
EP0904763A3 (de) 1999-12-15
DE69832766T2 (de) 2006-09-21

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