EP0960616B1 - Bouchon universel à utilisations multiples - Google Patents

Bouchon universel à utilisations multiples Download PDF

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Publication number
EP0960616B1
EP0960616B1 EP19990103563 EP99103563A EP0960616B1 EP 0960616 B1 EP0960616 B1 EP 0960616B1 EP 19990103563 EP19990103563 EP 19990103563 EP 99103563 A EP99103563 A EP 99103563A EP 0960616 B1 EP0960616 B1 EP 0960616B1
Authority
EP
European Patent Office
Prior art keywords
container
cylindrical
closure assembly
stopper
multiple use
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
EP19990103563
Other languages
German (de)
English (en)
Other versions
EP0960616A2 (fr
EP0960616A3 (fr
Inventor
John J. Niedospial Jr.
Mark E. Gabbard
Timothy J. Gabbard
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.)
Bracco International BV
Original Assignee
Bracco International BV
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 US09/080,091 external-priority patent/US5971181A/en
Application filed by Bracco International BV filed Critical Bracco International BV
Publication of EP0960616A2 publication Critical patent/EP0960616A2/fr
Publication of EP0960616A3 publication Critical patent/EP0960616A3/fr
Application granted granted Critical
Publication of EP0960616B1 publication Critical patent/EP0960616B1/fr
Anticipated expiration legal-status Critical
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
    • A61J1/2096—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
    • A61J1/1406—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
    • A61J1/1412—Containers with closing means, e.g. caps
    • A61J1/1425—Snap-fit type
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1475—Inlet or outlet ports
    • A61J1/1481—Inlet or outlet ports with connection retaining means, e.g. thread or snap-fit
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1475—Inlet or outlet ports
    • A61J1/1487—Inlet or outlet ports with friction fit, e.g. connecting tubes directly to a protruding port
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D51/00—Closures not otherwise provided for
    • B65D51/002—Closures to be pierced by an extracting-device for the contents and fixed on the container by separate retaining 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
    • A61J1/1468—Containers characterised by specific material properties
    • 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
    • A61J1/2044—Separating means having slits
    • 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

  • This invention relates to a multiple use universal closure assembly according to the preamble of claim 1.
  • the prior art has developed numerous devices to prevent accidental needle strike injuries to practitioners and patients. Such injuries are known to spread infectious diseases including hepatitis and AIDS.
  • One of the main features of these devices is the lack of exposed sharp needles.
  • the closures or stoppers have built in access means to the content of the containers, such as vials, cartridges and bottles. The closures or stoppers in these devices serve the dual function of hermetically sealing the container while allowing access to the content therethrough.
  • Stopper systems for containers such as vials and bottles are made of materials that are resistant to chemicals and pharmaceuticals such as corrosive materials, reagents, parenteral solutions and solid formulations reconstitutable with a solvent prior to use.
  • the most commonly used stopper/container system for such products has been glass or plastic bottles and vials equipped with stoppers made of elastomeric materials.
  • the system provides for good hermetical seal, safe storage and easy access to the content through the elastomeric stopper via the use of an infusion spike or a syringe when withdrawal of the content is desired.
  • the elastomeric stopper used generally comprises an elastomeric base, such as natural or synthetic rubber and an inert coating covering at least some portions of the stopper.
  • the coating used includes chlorobutyl rubber, polymeric fluorocarbon resins such as polytetrafluoroethylene and various thermoplastic films. The coating is intended to insulate the elastomeric stopper base from the contents of the container in order to prevent contact and possible chemical reactions therebetween.
  • the elastomeric stopper is of cylindrical shape and has a flange head portion overlying the open top end of the container. Integral with the head portion is a body portion which extends into the open end and seated in the neck portion of the container, the diameter of the body portion being somewhat larger than the inside diameter of the container so that a tight seal is created between the body portion and the wall of the container.
  • the lower end of the body portion is beveled towards the central, longitudinal axis of the body portion to facilitate the insertion of the body portion into the container.
  • the circular bottom surface that faces the contents of the container is substantially planar and is imperforate, having no recess therein.
  • the head portion of the stopper is provided with a central recess extending downwardly from the top thereof a substantial distance into the body portion so that the central recess and the circular bottom surface define a diaphragm.
  • the walls forming the recess are generally cylindrical but may be provided with one or more circular protuberances extending inwardly to terminate just short of the center line of the stopper.
  • the circular protuberances serve to press against and hold the needle of a syringe when the needle is inserted through the recess to penetrate the diaphragm for removal of the contents of the container (see U.S. PATENT No. 5,060,812 column 4, lines 48-55, figure 7).
  • the elastomeric stopper is held in position by a metal ring or cap usually constructed of aluminum.
  • the metal ring or cap has a removable centre opening for allowing insertion of the syringe needle into the container.
  • U.S. Patent No. 5,429,256 pertains to a drug withdrawal system for a vial.
  • the withdrawal system comprises: a vial containing a medicament therein and closed with a rubber gasket; and an apparatus which snap fits on top of the vial.
  • the apparatus comprises: a chassis and a cap which is attached to the cap by a living hinge.
  • the chassis is cylindrical and has vertical grooves on the external sides to facilitate handling.
  • the top of the chassis has a central opening.
  • the chassis includes a removable male luer lock adapter, having external threads thereon, including a ferrule structure the lower end of which has a hollow sharpened lance.
  • the apparatus is used with a syringe having a female luer lock connector which snap fits with the removable male luer lock adapter including the ferrule.
  • the cap cover is opened, and a syringe is screwed onto the outer end of the adapter, then tightened on the adapter which moves the lance downward thereby establishing flow communication with the content of the vial.
  • U.S. Patent No. 5,433,330 relates to a needleless access stopper used on containers with a cannula having a blunt, stopper penetrating tip.
  • the stopper includes a disc and a plug extending from the disc into the container.
  • a diaphragm defined by a target region in the upper face.
  • a centrally located piercing point positioned to pre-slit the diaphragm.
  • This stopper is not suitable for syringe, cartridge or IV tubing having a female luer connector.
  • the pre-slit disc does not assure a complete seal of the contents of the container from the environment and it is not useful for multiple use. (see also WO 94 /03373).
  • the present invention provides a multiple use universal closure assembly allowing repeatedly access to a medical fluid contained in a container with various external access means available to healthcare professionals and emergency practitioners and sometimes to patients requiring self-injections, such as cartridge or iv tubing equipped with a female luer connector or a syringe having sharp or blunt needle cannula or sharp and blunt spikes.
  • the present invention provides a multiple use universal closure assembly allowing access to a medical fluid contained in a container comprising accessing (receiving) and sealing means designed for multiple use so that the medical fluid can be repeatedly accessed. After each withdrawal of the desired amount of the medical fluid, the sealing means self-seals itself thereby preventing contamination of the medical fluid by air-born particles, such as dust and bacteria.
  • the multiple use universal closure assembly comprises the features defined in claim 1.
  • the elastomeric stopper according to the invention having a head portion and a skirt portion is made of an elastomeric base, such as a natural or synthetic rubber preferably having an inert, polymeric coating thereon covering at least the medical fluid contacting portions of the stopper.
  • the coating may be of chlorobutyl rubber, polymeric fluorocarbon resins and thermoplastic films.
  • the elastomeric stopper is of cylindrical shape and has a flange head portion overlying the open top end of the container. Integral with the head portion is a skirt portion which extends into the open end and seated in the neck portion of the container, the diameter of the neck portion of the container being somewhat larger than the inside diameter of the skirt portion so that a tight seal is created between the skirt portion and the wall of the container.
  • the cylindrical opening In the centre portion of the elastomeric stopper there is a cylindrical opening extending through the head and the skirt portions of the stopper.
  • the cylindrical opening through the stopper body would expose the content of the container to the environment allowing contamination therefrom.
  • the cylindrical opening is closed by a sealing means, namely a rupturable sealing membrane.
  • the rupturable sealing membrane may be made separately from the elastomeric stopper, positioned in the opening, and sealed into the elastomeric stopper using thermoplastic or other sealing means known in the art.
  • the elastomeric stopper and the sealing membrane are integral with each other and produced by blow molding or other suitable manufacturing techniques.
  • the sealing membrane is preferably a protuberance residing in the top half of head portion of the elastomeric stopper and is resembling an M-shaped configuration comprising: vertical leg portions or cylindrical side wall; a top surface resembling a cup or U-shaped portion extending downwards and toward the bottom portion of the elastomeric stopper, forming an M-shaped configuration when taken together with the cylindrical side walls.
  • the rupturable sealing membrane is of thin, elastomeric material preferably having a slit in its centre portion which slit does not completely traverse the centre portion of the rupturable sealing membrane.
  • the M-shaped sealing membrane in the elastomeric stopper would collapse, or at least deform when penetrated by a luer connector, sharp or blunt syringe cannula.
  • a rigid, cylindrical housing or male element open at both ends are provided to support the M-shaped sealing membrane and also serving as a receiving (accessing) means for an external access means.
  • Such external access means is preferably female access means, such as a female luer connector.
  • Such external access means are threaded into the male connecting means thereby rupturing the sealing membrane to establish fluid communication with the content of the container.
  • the multiple use universal closure assembly further comprises a cylindrical collar; and further a removable cap.
  • the cylindrical collar preferably made of metal such as aluminum, is fastened over the elastomeric stopper and the neck portion of the container to securely hold the elastomeric stopper in the open end of the container.
  • the cylindrical collar comprises a central opening in its flat top portion to allow access to the cylindrical opening in the stopper and to the sealing membrane and receiving means (male element) located in the cylindrical opening.
  • the removable cap covers the flat top and rim portions of the cylindrical collar and comprises retaining ears which engage the cylindrical collar to maintain the closure assembly in aseptic condition.
  • the present invention provides a multiple use universal closure assembly and container combination comprising the features defined in claims 13 or 14.
  • the present invention provides a method for repeatedly accessing a medical fluid contained in a container equipped with the multiple use universal closure assembly of the present invention comprising the steps of:
  • the present invention provides sealing and accessing means for containers such as bottles or vials made of glass or plastic containing medical fluids, such as x-ray contrast media and parenteral liquids.
  • the access means of the closure assembly of the present invention provides for hermetic sealing, safe handling, sterilization and storing.
  • the sealing means are designed for multiple use so that the medical fluid can be accessed repeatedly. After each withdrawal of the desired amount of the medical fluid, the sealing means self-seals itself thereby preventing contamination of the medical fluid by air-born particles, such as dust and bacteria.
  • the invention includes sealing and receiving (accessing) means for containers in general which comprise rigid or semi rigid access ports and are capable of receiving such sealing and access means.
  • the container is preferably made of glass, however, it can also be made of polymeric materials known in the art.
  • the container has a neck portion terminating in an open end to receive the closure assembly which is inserted in the open end to seal the content therein and maintain it in sterile and aseptic condition
  • the access means comprise no “sharps”, such as in sharp needle cannulas, in order to prevent accidental injuries and transmittance of contagious diseases, such as AIDS.
  • the external access means is preferably a syringe, cartridge or IV tubing having a female luer connector.
  • other access means such as a syringe having a sharp or blunt needle cannula or a spike may also be used to rupture the sealing membrane of the closure assembly.
  • the container 10 having an open end in which the multiple use universal stopper is used comprises a neck portion 12, a side portion 14, and a bottom portion 16.
  • the multiple use universal stopper held securely in place by cylindrical collar 70 having an open area 71 in its top centre portion, said open area being defined by the circular rim denoted by the numeral 74.
  • Cylindrical collar further comprises a flat top surface 75 defined by circular rims 74 and 76 and top rim portion 73. Cylindrical collar 70 is crimped at its bottom rim 72 to neck portion 12 of the container.
  • FIG. 1B shows locking ears 50 constituting a part of the universal stopper which is described later in reference to other Figures as the description of the invention proceeds.
  • removable cap 18 covers flat top surface 75 and top rim portion 73 of cylindrical collar to maintain open area in top centre portion 71 of cylindrical collar and locking ears 50 in aseption condition during storage.
  • Removable cap 18 comprises: side rim portion 22, flexible retaining ears 24, and retainer button 26.
  • retaining ears 24 are slid under circular rim 74 in cylindrical collar 70 providing a tight seal between removable cap 18 and flat top surface 75 of cylindrical collar.
  • Retainer button 26 together with retaining ears 24 also serve to limit expansion of the thin elastomeric membrane or seal during sterilisation.
  • the open end of the container 10 is to receive an elastomeric stopper 60 having a top surface 63 and a bottom surface 65 and comprises: a head 62 and a skirt 64 integral therewith.
  • the head comprises a flange 66, extending laterally outwardly from skirt 64 and is designed to cover the transverse end surface of the container.
  • the elastomeric stopper shown in FIGS. 6 and 6A is conventionally used by the prior art. In the present invention, as best seen in FIGS.
  • the elastomeric stopper further comprises: a cylindrical opening 68 in its centre portion defined by cylindrical walls denoted by the numerals 80 and 80'; bottom ring portion denoted by the numerals 82 and 82'; and funnel shaped opening 83 extending downward from the bottom ring portion into the container defined by walls 84 and 84'.
  • Projecting upward towards the top surface 63 of elastomeric stopper 60 is a hollow, vertically-oriented, cylindrical protuberance 85 defined by cylindrical walls 86 and 86' and top surface 120.
  • Top surface 120, along with cylindrical walls 86 and 86', are designed to serve as the elastomeric seal in the elastomeric stopper.
  • the cylindrical protuberance is preferably integral with the stopper body such as produced by blow molding technique or it may be produced separately and sealed into the central opening defined by walls 80 and 80' in the elastomeric stopper 60.
  • the vertically-oriented cylindrical protuberance is of thin, membrane-like material designed to be ruptured by an external force exerted on the protuberance by an external access means, such as a luer connector.
  • the cylindrical protuberance is an M-shaped diaphragm wherein the numerals 86 and 86' denote the leg portions and the numeral 120 denotes the top surface resembling a cup shape. The lowest point in the top surface 120 is denoted by the numeral 121 which is the centre point in the cup-shaped portion.
  • a slit 122 extending from the top surface or inside surface toward the bottom surface 125 of the cup-shaped portion of the M-shaped diaphragm.
  • the slit does not penetrate the bottom surface 125.
  • the thickness between the slit 122 and the intact bottom surface 125 is typically of form about 0.001 to about 2.0 mm.
  • the unpenetrated portion of the membrane denoting its thickness at the centre portion is denoted by the numeral 127 in FIGS. 4B and 4C. The unpenetrated membrane maintains the content of the container in sealed condition.
  • a cylindrical housing or male element (receiving means) generally designated as 100 is provided, located in the upper centre portion 68 of elastomeric stopper 60.
  • Housing 100 comprises: cylindrical wall 102 having a top surface 104 and bottom surface 106.
  • Cylindrical wall 102 comprises an inside wall 108, an outside wall 110, locking ears 50, and horizontally-oriented bottom portion 112.
  • Locking ears 50 is designed to securely hold the female element of a luer connector.
  • Horizontally-oriented bottom portion 112 extends into the skirt 64 and sealed thereto at the bottom ring portion 82 and 82' of elastomeric stopper 60.
  • the cylindrical protuberance serving as a sealing membrane is of inert gas-impermeable polymeric material capable of flexing under internal or external pressures such as exerted during steam sterilisation.
  • the membrane has a thickness of from about 0.001 mm to about 2.00 mm and a durometer of from about 25 to about 80 Shore A.
  • Suitable elastomeric materials for constructing the membrane include:
  • the cylindrical M-shaped protuberance is positioned in elastomeric stopper 60 so that its top surface 120 is spaced about 2 to 3 mm form retainer button 26 of removable cap 18 when the cap is placed on container 10.
  • the spacing allows the membrane to flex outwardly under pressure, such as created under heat sterilisation. However, spacing should not be more than about 2 to 3 mm so that under accidentally high pressures, bursting of the membrane is prevented by the retaining button 26 of removable cap 18.
  • the multiple use universal closure assembly of the present invention may also have a configuration shown in FIGS. 9 and 10.
  • the stopper of this configuration is used when lyophilization of the content of the container is desired. Prior to use the lyophilized content is reconstituted by injecting into the container through the multiple use universal stopper water, saline or other liquids.
  • the universal closure assembly of the present invention is preferably used with an external female luer connector when fluid communication is desired with the content of the container stoppered by the universal stopper.
  • a typical female luer connector 140 is shown in FIG. 11 and comprises: cylindrical outside wall 142 and cylindrical inside wall 143 having an opening in their centre portion for accommodating a tubing within the inside wall. Cylindrical ring 144 located in the top centre portion of cylindrical inside wall 143 tightly holds tubing 160 which has a fluid communicating channel 162.
  • Cylindrical inside wall 143 further comprises integral screw threads 146, 148, 150 and 152 which, upon connecting the female luer connector to the male luer connector, engages locking ears 50 on the housing or male element 100, as shown in FIGS. 7 and 7A.
  • Other type of female luer connectors, such as snap-on connectors may also be used.
  • FIG. 12 shows, in cross-sectional view, a syringe having a female luer connector, which is to engage the multiple use universal stopper in the container 10, wherein the syringe and universal stopper are shown prior to their engagement.
  • removable cap 18 is removed by an upward manual pressure exerted on its rim portion 22 thereby exposing locking ears 50 of the access means housing.
  • the female luer connector of FIG. 11 is used, it is attached to the multiple use universal closure assembly by twisting motion wherein threads 146, 148, 150 and 152 engage locking ears 50 of access means housing 100. Upon turning the female luer connector 140, end portion of tubing 160 ruptures membrane of the universal stopper to establish fluid communication with the content of the container.
  • FIG. 12A shows, in cross-sectional view, the syringe having the female luer connector partially engaging the multiple use universal closure assembly.
  • FIG. 12B shows, in cross-sectional view, the syringe having the female luer connector completely engaging the multiple use universal closure assembly.
  • FIG. 13 shows, in cross-sectional view, the syringe having the female luer connector removed from the multiple use universal closure assembly after their engagement.
  • the multiple use universal closure assembly can be engaged by an external female luer connector having a blunt end which engages and ruptures the cylindrical M-shaped seal in the centre of the multiple use universal closure assembly.
  • the multiple use universal stopper also allows access to the content of the container by a sharp or blunt needle cannula or a spike.
  • the elastomeric stopper used in conjunction with the universal stopper of the present invention is fluid impervious, resilient, and inert without leachable additives therein in order to prevent any alteration of the product contained in the container. It may be of a single component or a blend of components. Examples of materials include synthetic and natural rubbers, such as butyl rubber, isoprene rubber, silicone rubber, halogenated rubber, ethylene propylene therpolymer and the like.
  • a synthetic elastomeric rubber examples include the CH 2 CF 2 -C 3 F 6 (C 3 F 5 H) and the C 2 F 4 -C 2 F 3 OCF 3 series of elastomers made by DuPont under the trade names of VITON® and CARLEZ®; the fluoro-silicone rubbers, such as those made by Dow Corning under the trade name of SILASTIC®; and polyisobutylenes, such as VISTANEX MML-100 and MML-140; and halogenated butyl rubber, such as CHLOROBUTYL 1066, made by Exxon Chemical Company.
  • elastomers may be made into the desired stopper configuration by known methods. Such methods conventionally include the use of a curing agent, a stabilizer and a filler and comprise a primary and a secondary curing step at elevated temperatures.
  • the container used in conjunction with the present invention may be of glass or a polymeric material, i.e., plastic, which are well known in the pharmaceutical industry.
  • the container When the container is made of glass, it is in the shape of a vial or bottle.
  • the vial or bottle is of rigid or semi-flexible polymeric material.
  • the container In all shapes the container is provided with a neck portion which is rigid and retains its configuration so that it is capable of being hermetically sealed by the elastomeric universal stopper of the present invention.
  • the container may have a volume capacity of from 5 ml to 1000 ml or more, preferably about 10 ml to 500 ml.
  • the mouth of the container is to receive the multiple use universal closure assembly.
  • the external diameter of the stopper is slightly larger than the internal diameter of the neck of the container so that on insertion of the multiple use universal stopper into the mouth of the container, a tight, hermetic seal is achieved.
  • the cylindrical collar is preferably made of metal, such as aluminum, while the housing is made of hard plastic known by the prior art and used in conjunction with pharmaceutical fluids.
  • the container and component parts of the closure Prior to use, the container and component parts of the closure are sterilised and the container is filled with a pharmaceutical fluid, such as a parenteral solution.
  • a pharmaceutical fluid such as a parenteral solution.
  • the multiple use universal stopper is inserted, hermetically sealing the content of the container. Cylindrical collar is then crimped onto the container to securely hold the multiple use universal closure assembly in the container. Lastly, the removable cap is snapped onto the cylindrical collar to complete the closing of the container.

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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)
  • Closures For Containers (AREA)

Claims (20)

  1. Assemblage de fermeture universelle à usage multiple pour permettre un accès répété à un fluide médical contenu dans un conteneur (10), comprenant:
    un bouchon en élastomère (60) pour sceller hermétiquement le conteneur, comprenant, à son extrémité ouverte,
    une portion de tête (62);
    une portion de jupe (64);
    une ouverture cylindrique (68) au centre desdites portions de tête (62) et jupe (64); et
    des moyens de scellement; caractérisé en ce que les moyens de scellement sont capables d'auto-scellement après chaque retrait du fluide médical, lesdits moyens de scellement étant une protubérance (85) résidant dans la moitié supérieure de la portion de tête du bouchon en élastomère (60) et en ce que ledit assemblage de fermeture comprend de plus un moyen de réception pour un moyen d'accès externe conventionnel, ledit moyen de réception étant un logement cylindrique rigide (100) ouvert aux deux extrémités supportant ladite protubérance.
  2. Fermeture universelle selon la revendication 1 où ledit moyen de scellement fait corps avec ledit bouchon en élastomère.
  3. Assemblage de fermeture universelle à usage multiple selon la revendications 1-2 où ledit moyen de scellement est une membrane pouvant être rompue ressemblant à une configuration en forme de M.
  4. Fermeture universelle de la revendication 3, où ladite membrane de scellement pouvant être rompue ressemblant à une configuration en forme de M comprend: des portions de jambes verticales (86, 86'); une surface supérieure (120) ressemblant à une coupe ou une portion en forme de U s'étendant vers le bas et vers la portion de fond du bouchon en élastomère (60), formant une configuration en forme de M, quand elle est prise avec les portions de jambe (86, 86'); ladite membrane de scellement pouvant être rompue étant faite d'un matériau élastomère mince ayant une fente (122) à sa portion centrale, laquelle fente (122) ne traverse pas complètement la portion de fond (125) de la membrane de scellement pouvant être rompue.
  5. Fermeture universelle selon les revendications 3-4 où ladite membrane pouvant être rompue est en un matériau polymérique inerte, imperméable aux gaz, sélectionné dans le groupe consistant en:
    caoutchouc naturel;
    caoutchouc d'acrylate-butadiène;
    cis-polybutadiène
    caoutchouc chlorobutyle;
    élastomères de polyéthylène chloré;
    polymères d'oxyde de polyalkylène;
    éthylène vinyl acétate;
    caoutchoucs de fluorosilicone;
    terpolymères d'hexafluoroisopropylène-fluorure de vinylidène-tétrafluoroéthylène;
    caoutchoucs butyle;
    polyisobutène;
    caoutchouc de polyisoprène synthétique;
    caoutchoucs de silicone;
    caoutchoucs de styrène-butadiène;
    copolymères de tétrafluoroéthylène propylène; et
    copolyesters thermoplastiques.
  6. Assemblage de fermeture universelle selon les revendications 3-5 où ladite membrane pouvant être rompue a une épaisseur d'environ 0,001 mm à environ 1,00 mm et un duromètre d'environ 25 à environ 80 Shore A.
  7. Assemblage de fermeture universelle selon la revendication 1, où ledit moyen de réception permet la connexion avec un moyen d'accès externe conventionnel comme une cartouche ou un tube iv équipé d'un connecteur luer femelle (140) ou une seringue ayant une canule à aiguille aiguë ou émoussée ou des pointes aiguës et émoussées.
  8. Assemblage de fermeture universelle selon la revendication 7 où ledit moyen de réception reçoit un moyen d'accès femelle externe.
  9. Assemblage de fermeture universelle selon la revendication 8, où ledit moyen d'accès femelle externe est un connecteur luer femelle (140).
  10. Assemblage de fermeture selon la revendication 1, où ledit logement cylindrique ou élément mâle (100) comprend: des parois cylindriques (102) ayant une surface supérieure (104) et une surface de fond (106); ladite paroi cylindrique (102) comprend une paroi intérieure (108); une paroi extérieure (110), des oreilles de blocage (50) et une portion de fond (112) s'étendant horizontalement; ladite oreille de blocage (50) est conçue pour maintenir solidement le connecteur luer femelle (140).
  11. Assemblage de fermeture universelle selon les revendications 1-10, comprenant de plus un collier cylindrique (70) fixé sur une portion dudit bouchon en élastomère (70) et pouvant être fixé sur une portion de col (12) d'un conteneur (10) pour maintenir solidement le bouchon en élastomère (60) dans l'extrémité ouverte du conteneur (10), ledit collier cylindrique (70) ayant une ouverture centrale dans sa portion supérieure plate pour permettre l'accès au moyen de réception et au moyen de scellement placés à la portion centrale du bouchon en élastomère (100).
  12. Assemblage de fermeture universelle selon la revendication 11 comprenant de plus un capuchon amovible (18) couvrant les portions de sommet plat (20) et de pourtour (22) dudit collier cylindrique (70).
  13. Combinaison assemblage de fermeture universelle à usage multiple et conteneur comprenant:
    un conteneur (10); et
    un assemblage de fermeture universelle à usage multiple selon les revendications 1-12.
  14. Combinaison assemblage de fermeture universelle et conteneur selon la revendication 13, comprenant:
    ledit conteneur (10) contenant un fluide médical ayant une portion de col (12) se terminant par une extrémité ouverte et
    ledit assemblage de fermeture comprenant les caractéristiques des revendications 4, 10 et 12, inséré dans l'extrémité ouverte dudit conteneur.
  15. Méthode pour un accès répété à un fluide médical comprenant les étapes de:
    i) prévoir une combinaison d'un assemblage de fermeture universelle à usage multiple selon la revendication 12 et un conteneur contenant ledit fluide médical ou une combinaison assemblage de fermeture universelle à usage multiple et conteneur selon la revendication 14;
    ii) enlever le capuchon amovible (18) des portions de sommet plat (75) et de pourtour (73) du collier cylindrique (70) pour ainsi exposer le moyen de scellement et le moyen de réception dans l'ouverture cylindrique du bouchon en élastomère (60); et
    iii) permettre l'accès du fluide médical contenu dans le conteneur (10) par un moyen d'accès externe.
  16. Méthode selon la revendication 15 où ladite membrane pouvant être rompue se rescelle d'elle-même après perforation par un moyen d'accès externe.
  17. Méthode selon la revendication 15, où ledit fluide médical est un liquide thérapeutique.
  18. Méthode selon la revendication 16, où ledit fluide médical est un liquide de diagnostic.
  19. Méthode selon la revendication 15, où ledit fluide médical est un liquide nutritif.
  20. Méthode selon les revendications 15-19, où une teneur lyophilisée est reconstituée par injection, dans le conteneur à travers ledit assemblage de fermeture universelle à usage multiple, d'eau, d'une solution saline ou d'autre liquide.
EP19990103563 1998-05-16 1999-02-24 Bouchon universel à utilisations multiples Expired - Lifetime EP0960616B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US80091 1987-07-31
US09/080,091 US5971181A (en) 1998-05-04 1998-05-16 Multiple use universal stopper

Publications (3)

Publication Number Publication Date
EP0960616A2 EP0960616A2 (fr) 1999-12-01
EP0960616A3 EP0960616A3 (fr) 2000-04-26
EP0960616B1 true EP0960616B1 (fr) 2004-09-08

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EP (1) EP0960616B1 (fr)
JP (1) JP4288742B2 (fr)
CA (1) CA2262477C (fr)
DE (1) DE69919935T2 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8998875B2 (en) 2009-10-01 2015-04-07 Medimop Medical Projects Ltd. Vial assemblage with vial and pre-attached fluid transfer device

Families Citing this family (61)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6666852B2 (en) * 2000-12-04 2003-12-23 Bracco Diagnostics, Inc. Axially activated vial access adapter
US6571971B1 (en) * 2001-02-08 2003-06-03 Weller Engineering, Inc. Hermetically sealed container with pierceable entry port
EP1384466A1 (fr) * 2002-07-23 2004-01-28 Fresenius Kabi Deutschland GmbH Bouteille de plastique destinée à recevoir un fluide, notamment une solution de nutrition entérale
WO2004103453A1 (fr) * 2003-05-22 2004-12-02 Otsuka Pharmaceutical Factory, Inc. Corps de fermeture, bouchon comprenant le corps de fermeture, et recipient medical
FR2939110B1 (fr) * 2008-11-28 2013-07-19 Sarol S A S Di Franzoni Pierfranco & C Bouchon a membrane
IL202070A0 (en) 2009-11-12 2010-06-16 Medimop Medical Projects Ltd Inline liquid drug medical device
IL209290A0 (en) 2010-11-14 2011-01-31 Medimop Medical Projects Ltd Inline liquid drug medical device having rotary flow control member
EP2750736B1 (fr) 2011-08-31 2020-09-23 AbbVie Inc. Agencement de scellement étanche pour une seringue
CN103826985B (zh) * 2011-09-29 2016-08-24 通用电气医疗集团股份有限公司 包装体
IL215699A0 (en) 2011-10-11 2011-12-29 Medimop Medical Projects Ltd Liquid drug reconstitution assemblage for use with iv bag and drug vial
SG11201404436XA (en) 2012-02-02 2014-08-28 Becton Dickinson Holdings Pte Ltd Adaptor for coupling with a medical container
SG192312A1 (en) 2012-02-02 2013-08-30 Becton Dickinson Holdings Pte Ltd Adaptor for coupling to a medical container
SG192310A1 (en) 2012-02-02 2013-08-30 Becton Dickinson Holdings Pte Ltd Adaptor for coupling to a medical container
USD737436S1 (en) 2012-02-13 2015-08-25 Medimop Medical Projects Ltd. Liquid drug reconstitution assembly
USD720451S1 (en) 2012-02-13 2014-12-30 Medimop Medical Projects Ltd. Liquid drug transfer assembly
IL219065A0 (en) 2012-04-05 2012-07-31 Medimop Medical Projects Ltd Fluid transfer device with manual operated cartridge release arrangement
IL221635A0 (en) 2012-08-26 2012-12-31 Medimop Medical Projects Ltd Drug vial mixing and transfer device for use with iv bag and drug vial
IL221634A0 (en) 2012-08-26 2012-12-31 Medimop Medical Projects Ltd Universal drug vial adapter
EP2872100B1 (fr) 2012-09-13 2017-03-29 Medimop Medical Projects Ltd Adaptateur télescopique femelle pour flacon de médicament
EP2735300A1 (fr) 2012-11-26 2014-05-28 Becton Dickinson France Adaptateur pour récipient médical multidoses
USD734868S1 (en) 2012-11-27 2015-07-21 Medimop Medical Projects Ltd. Drug vial adapter with downwardly depending stopper
JP6386471B2 (ja) * 2012-12-21 2018-09-05 フレゼニウス カービ ドイチュラント ゲーエムベーハー ミルク瓶アダプター
EP3777927A1 (fr) * 2013-02-12 2021-02-17 AbbVie Inc. Seringue avec pression d'étanchéité à deux étages
IL225734A0 (en) 2013-04-14 2013-09-30 Medimop Medical Projects Ltd A ready-to-use medicine vial device including a medicine vial closure, and a medicine vial closure for it
CN105228676B (zh) 2013-05-10 2018-01-05 麦迪麦珀医疗工程有限公司 包括具有内联干燥药物组件的小瓶转接器的医疗装置
JP1526207S (fr) 2013-08-05 2015-06-15
CN205626622U (zh) 2013-08-07 2016-10-12 麦迪麦珀医疗工程有限公司 与输液容器一起使用的液体转移装置
USD767124S1 (en) 2013-08-07 2016-09-20 Medimop Medical Projects Ltd. Liquid transfer device with integral vial adapter
USD765837S1 (en) 2013-08-07 2016-09-06 Medimop Medical Projects Ltd. Liquid transfer device with integral vial adapter
US10773067B2 (en) 2014-09-08 2020-09-15 Neomed, Inc. Enteral connectors having coupling features
USD757933S1 (en) 2014-09-11 2016-05-31 Medimop Medical Projects Ltd. Dual vial adapter assemblage
BR112017013534B1 (pt) 2015-01-05 2021-12-21 Medimop Medical Projects Ltd. Montagem do adaptador de frasco duplo para uso com um frasco de medicamento e um frasco de líquido
FR3035080B1 (fr) 2015-04-17 2019-08-09 Centre Hospitalier Universitaire D'amiens-Picardie Dispositif de bouchage pour permettre un prelevement d'une composition ensemble de conditionnement comprenant un tel dispositif de bouchage, procedes de prelevement et de conditionnement
EP3310322B1 (fr) 2015-06-18 2020-06-03 Neomed, Inc. Système de couplage seringue-à-seringue avec embout mâle
USD825746S1 (en) 2015-06-18 2018-08-14 Neomed, Inc. Syringe-to-syringe coupler
US10744317B2 (en) 2015-07-15 2020-08-18 Neomed, Inc. Enteral adaptor couplings
CN113143759B (zh) 2015-07-16 2024-01-30 西部制药服务以色列有限公司 用于安全的伸缩的卡扣配合在注射剂小瓶上的液体药物转移装置
USD801522S1 (en) 2015-11-09 2017-10-31 Medimop Medical Projects Ltd. Fluid transfer assembly
JP6523569B2 (ja) 2015-11-25 2019-06-05 ウエスト・ファーマ．サービシーズ・イスラエル，リミテッド 自己シール式アクセスバルブを有する薬瓶アダプタを備えるデュアルバイアルアダプタアセンブリ
US11166876B2 (en) 2016-02-24 2021-11-09 Neomed, Inc. Fluid transfer connector
EP3419582B1 (fr) 2016-02-24 2022-07-13 Avent, Inc. Raccord de transfert de fluide
IL245800A0 (en) 2016-05-24 2016-08-31 West Pharma Services Il Ltd A device with two vial adapters includes two identical vial adapters
IL245803A0 (en) 2016-05-24 2016-08-31 West Pharma Services Il Ltd Devices with two vial adapters include an aerated drug vial adapter and an aerated liquid vial adapter
IL246073A0 (en) 2016-06-06 2016-08-31 West Pharma Services Il Ltd A fluid transport device for use with a slide-driven piston medicine pump cartridge
IL247376A0 (en) 2016-08-21 2016-12-29 Medimop Medical Projects Ltd Injector assembly
USD832430S1 (en) 2016-11-15 2018-10-30 West Pharma. Services IL, Ltd. Dual vial adapter assemblage
USD833006S1 (en) 2016-11-28 2018-11-06 Neomed, Inc. Fluid transfer connector
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
IL251458A0 (en) 2017-03-29 2017-06-29 Medimop Medical Projects Ltd Liquid drug delivery devices are user-operated for use in pre-prepared liquid drug delivery assemblies (rtu)
IL254802A0 (en) 2017-09-29 2017-12-31 Medimop Medical Projects Ltd A device with two vial adapters includes two identical perforated vial adapters
USD903864S1 (en) 2018-06-20 2020-12-01 West Pharma. Services IL, Ltd. Medication mixing apparatus
JP1630477S (fr) 2018-07-06 2019-05-07
UA119731C2 (uk) * 2018-08-29 2019-07-25 Сіа Емтеко Холдинг Рідка дозована форма едаравону або його фармацевтично прийнятних солей, стабільна при зберіганні, транспортуванні та використанні
USD923812S1 (en) 2019-01-16 2021-06-29 West Pharma. Services IL, Ltd. Medication mixing apparatus
JP1648075S (fr) 2019-01-17 2019-12-16
WO2020157719A1 (fr) 2019-01-31 2020-08-06 West Pharma. Services Il, Ltd Dispositif de transfert de liquide
CA3135248C (fr) 2019-04-30 2024-01-02 Yossi Bar-El Dispositif de transfert de liquide avec pointe iv a double lumiere
WO2021216821A1 (fr) * 2020-04-24 2021-10-28 West Pharmaceutical Services, Inc. Systèmes de confinement
USD956958S1 (en) 2020-07-13 2022-07-05 West Pharma. Services IL, Ltd. Liquid transfer device
DE102020118855A1 (de) 2020-07-16 2022-01-20 Sarstedt Ag & Co. Kg Vorrichtung
US11903902B2 (en) 2022-01-03 2024-02-20 Benjamin Martin DAVIS Fluid transfer couplings

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2906423A (en) * 1956-07-18 1959-09-29 American Cyanamid Co Closure puncturable by polyethylene needle
FR1325077A (fr) * 1962-03-16 1963-04-26 Bouchon, en particulier pour flacon de perfusion sanguine
FR1358506A (fr) * 1963-03-04 1964-04-17 Paul Metadier Lab Perfectionnements aux appareillages de transfusion et perfusion
US4274543A (en) * 1978-01-23 1981-06-23 The Upjohn Company Vial and closure structure
US5060812A (en) * 1990-09-06 1991-10-29 International Medication Systems, Limited Medication container stopper which can be punctured by nozzle of a hypodermic syringe
DE4112209A1 (de) * 1991-04-13 1992-10-15 Behringwerke Ag Behaelterverschluss mit durchstossbarem verschlusskoerper
CZ29095A3 (en) * 1992-08-07 1995-07-12 West Co Closing device for little containers, particularly for medicaments, for providing access without need of needle
JPH06191546A (ja) * 1992-12-25 1994-07-12 Nikko Composite Kk 容器用栓
US5429256A (en) 1994-01-24 1995-07-04 Kestenbaum; Alan D. Drug withdrawal system for container
JPH0880292A (ja) * 1994-09-12 1996-03-26 Nittec Co Ltd 容器栓
IL112816A0 (en) * 1995-02-27 1995-05-26 Travenol Lab Israel Ltd Infusion bag with injection port

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8998875B2 (en) 2009-10-01 2015-04-07 Medimop Medical Projects Ltd. Vial assemblage with vial and pre-attached fluid transfer device

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EP0960616A2 (fr) 1999-12-01
DE69919935D1 (de) 2004-10-14
JPH11321916A (ja) 1999-11-24
CA2262477A1 (fr) 1999-11-16
JP4288742B2 (ja) 2009-07-01
CA2262477C (fr) 2008-02-12
DE69919935T2 (de) 2005-09-15
EP0960616A3 (fr) 2000-04-26

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