EP0915692B1 - Verfahren und vorrichtung zur abdichtung und zum anschliessen eines behälters - Google Patents

Verfahren und vorrichtung zur abdichtung und zum anschliessen eines behälters Download PDF

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Publication number
EP0915692B1
EP0915692B1 EP97932063A EP97932063A EP0915692B1 EP 0915692 B1 EP0915692 B1 EP 0915692B1 EP 97932063 A EP97932063 A EP 97932063A EP 97932063 A EP97932063 A EP 97932063A EP 0915692 B1 EP0915692 B1 EP 0915692B1
Authority
EP
European Patent Office
Prior art keywords
connector
closure
sharp
container
opening
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
EP97932063A
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English (en)
French (fr)
Other versions
EP0915692A1 (de
Inventor
Percy Bennwick
Olle Ljungquist
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.)
Pfizer Health AB
Original Assignee
Pharmacia AB
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 SE9602749A external-priority patent/SE9602749D0/xx
Application filed by Pharmacia AB filed Critical Pharmacia AB
Publication of EP0915692A1 publication Critical patent/EP0915692A1/de
Application granted granted Critical
Publication of EP0915692B1 publication Critical patent/EP0915692B1/de
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
    • A61J1/2089—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

Definitions

  • the present invention relates to a device for sealing or connecting a container, having at least one opening with an opening axis, comprising (a) a closure member for arrangement in, at or around the opening and having at least one pierceable part, (b) a connector attachable, when oriented at least partially coaxial with the opening, at a proximal end to the container and at a distal end directly or indirectly to a vessel in the form of a second container, a syringe or a duct and (c) a sharp operable to penetrate at least the pierceable part and to establish a fluid communication between the container and the vessel.
  • the invention also relates to a method for sealing or connecting a container.
  • Typical situations are withdrawal of preparation from a vial by use of a syringe type device or the introduction of a solvent or diluent to the vial by similar means, the connection of a container to a conduit e.g. for infusion or the connection of a rigid container to a flexible bag for interchange of their contents.
  • the purpose may be to withdraw a content sample from the container, to add a component to the container for example to dissolve, dilute or mix components before administration or a more complicated exchange for example when dissolving a container component with a solvent from a vessel or bag for later reintroduction of the dissolved preparation into the vessel.
  • the container sterility and integrity is secured by a permanent seal including a pierceable septum that has to be penetrated by sharp object such as a needle or cannula to establish the desired fluid communication.
  • Preparation steps prior to connection may require special conditions limiting the possibilities to employ manual manipulation steps and placing special design requirements on the device parts involved.
  • the container has to be subjected to sterilization, which at least require the parts to sustain sterilization conditions, such as heat, irradiation etc.
  • sterilization conditions such as heat, irradiation etc.
  • the access may then be secured in known manners, such as by keeping the sealing parts remote from container opening until the sealing operation or by resting on the container openings sealer elements having channels or cut-outs which are closed by and at the sealing operation.
  • a common connector type as represented by e.g. US 3 872 867 and EP 499 481, relies on an axial compression of the containers against a fixed needle to establish the fluid connection
  • a similar type as represented by e.g. US 5 445 631, EP 570 939 and WO 94/00094, uses a slideable needle for the same purpose.
  • EP 533 171 a threaded engagement is used to axially displace a sharp in a corresponding manner for membrane penetration and plug removal.
  • a sharp is displaced when an axial pressure overcomes a friction ridge.
  • a main object of the present invention is eliminate or reduce the abovesaid deficiencies of the prior art methods and means.
  • a more specific object is to facilitate and reduce the number of steps for the user in making necessary connections.
  • Another object is to increase control over connection sequence.
  • Yet another object is to allow for safe connection without undue release of particles from closure means.
  • Still another object is to facilitate container manufacture and pretreatment steps.
  • a further object is to assist in container closure, sealing and contamination protection.
  • Yet another object is to reduce the number of parts to be handled in the pretreatment and connecting steps.
  • connecting means allowing at least two defined positions relative the closure or capping means as stated and a mechanism for control of movement therebetween several of the objects are reached.
  • the connector In a first position the connector may act as integral with the closure or capping. In manufacture and pretreatment steps this allows for treatment of the device as a unit in any chamber process, which obviates additional assembly steps yet permitting all common procedures such as sterilizing and lyophilization of container content as well as final sealing of the container by pushing the unit so as to bring the closure into engagement with the container.
  • the device When so used the device may be sterilized together with the container and, as no need exists for later separation therebetween, contamination of the interface is prevented.
  • the distal end of the connector may be sealed with a membrane, which can be easily done as the only functional limitation on this part may be to sustain a flat pressure in the abovesaid closing step.
  • a membrane which can be easily done as the only functional limitation on this part may be to sustain a flat pressure in the abovesaid closing step.
  • the integral character in the first position assists in maintaining the device unarmed and secured against unintentional release, which also extends to any sharp attached to the connector.
  • the connecting procedure the fact that the connector is already safely attached to the container relieves the user from this step and limits the connecting operation to the secondary device.
  • the mechanism for control of movement to the second position now acts as an important control means for the connecting sequence, allowing the user either to first make the fluid connection to the container or to the secondary device or both substantially simultaneously, in dependence of special conditions such as over or under pressure, which control cannot be obtained in known devices with freely sliding sharps or sleeve parts. Yet the actual coupling movement can still be made substantially axially and does not require threading or twisting actions prone to create particle or debris release. In spite of the advantages offered the invention does not add to complexity.
  • the device only uses standard components, although modified, i.e. closure means and a connector piece with sharp, and the functional requirements of force transfer and axial connection permit a simple part design, easily compatible with the manufacturing conditions mentioned and a material selection free of metal parts, if desired. As said the method steps required represents a simplification in relation to existing procedures.
  • the primary container for the sealing and connecting can take a variety of forms such as any kind of container or vessel, flexible bag, vial, ampoule, cartridge, carpoule, syringe body etc.
  • containers that are rigid, at least at its opening but preferably generally rigid, such as vials, ampoules or syringe bodies.
  • the container has at least one opening to be sealed or connected by means of the invention but may have further openings which can be identical to the at least one opening but which can be entirely different and for example be adapted for another purpose of e.g. infusion or syringe type with a movable wall or piston.
  • the principles of the invention can with advantage be used for more than one opening on the container.
  • the opening "axis" will be given in relation to the opening "axis" by which shall be understood a line perpendicular to the opening surface or opening cross-section just at its outlet and being centered at its symmetry axis in case of rotation symmetry or momentum center in case of other shapes. Expressed in another way the axis may be directed perpendicular to and centered relative the flow through the opening which in most instances give about the same meaning.
  • a plain tube shape opening or a hole with rigid rim can be closed with an inserted simple plug or stopper type sealing and the tube type opening also with an external friction fit, possibly supplemented with an adhesive or curing of the sealer part. It is preferred, however, to assist with some kind of physical attachment of the closure means for which purpose it is preferred to provide protruding or recessed structures for cooperation with complementary shaped closure parts. These structures may be located on the opening interior, exterior or both, preferably at least on the exterior when space so permits. Although threads or bayonet type structures are conceivable it is preferred to use structures allowing engagement with a simple axial relative displacement between container and closure, without requirement for substantial angular motions.
  • Such structures may include circumferential flanges, grooves, undercut etc., continuous or intermittent, around the opening, including the common bottle-type with orifice flange, neck and shoulder parts.
  • Several such structures may be used, e.g. axially displaced for example in order to assist positioning of closure parts in an open position, allowing gas exchange, and a closed position.
  • the device includes a closure for the container able to seal off container interior and being designed to be penetrable, before or after removal of protective material, by a sharp included in the connector part.
  • "Closure” as used herein shall be understood as a general concept for device parts fulfilling these objects and may be a integral or composite structure to be further explained.
  • a minimum requirement on the closure design for the present purposes is that it shall be able to receive an axial pressure to be pushed into engagement with the opening, which in broad terms only requires that the closure have a suitable part with a surface component, i.e. flat, inclined or curved, transversal to the axial direction, Such surfaces may be provided especially with this object in mind, e.g.
  • a rim surface adapted to the connector or lateral cut-outs for engagement with pushing hooks.
  • An entirely conventional design is also usable, however, as normally including a flange or rim portion or at least a closing top surface.
  • a preferred general design is a sleeve portion extending axially and a closing top surface.
  • the sleeve part may be designed to be inserted in the opening interior but is preferably designed to engage the opening on its exterior when having a tube or neck part.
  • the closure may have structures adapted for cooperation with similar structures on the container for the abovesaid physical attachment purpose, preferably allowing a push fit engagement, either relying on resiliency of the part itself or assisted by a separate locking ring.
  • the closure before the sealing is kept remote from the container by entirely independent means and brought into contact with the container at sealing
  • the closure may be provided with at least two axially displaced attachment structures, preferably in an axial sleeve part when present, in addition to or as an alternative to the abovedescribed similar designs placed on the container.
  • slits, channels, holes or cut-outs may be provided in the closure, also preferably in an axial sleeve part when present in a manner known per se.
  • the general closure properties may, but do not have to, include specially designed locking features for cooperation with similar details on the connector part to permit transition from a first position to a second position, with the sharp in non-penetrating and penetrating relationship to the pierceable sealer respectively, which will be further described hereinbelow.
  • closure comprises a pierceable sealer part and a capping part at least acting to secure the sealer against displacement from the opening.
  • a “sealer” shall be understood in broad sense as a part being pierceable by the sharp, to be further explained, and may for example include valves, displaceable members in the opening, parts being deformable to an unsealing condition etc.
  • the sealer can be made in materials common in the art with low disposition for particle release when penetrated and with good ability to again close after penetration and withdrawal of the sharp, e.g. elastic rubber materials.
  • the sealer shape may be any conventional, such as a more or less flat membrane or septum covering the opening orifice, a cap type shape extending over and around the opening exterior or most preferably a plug or stopper type inserted in the opening.
  • the sealer especially when of the plug type shape, may have cavities or recesses to limit the penetration depth needed for the sharp to reach container interior.
  • the sealer in itself may be an integral structure or be composed of several layers or parts.
  • the capping shall be able to engage the opening in a releasable or preferably a permanent manner, i.e. with some irreversible destruction necessary for release of the capping.
  • the engagement structures discussed above in relation to the closure in general, which shall not here be repeated, are preferably placed on the capping part when present.
  • the capping should at least cover it partially and optionally also compress it, especially when the sealer covers the opening orifice or exterior parts.
  • the capping leaves at least an area part, and preferably a central area part, of the sealer uncovered to permit access for the sharp during the penetration step, which shall not exclude that said area is covered by a thin penetrable capping part or a part designed to be removed immediately before the penetration step, such as with a tearing weakening or the common flip-off design.
  • the area can be adapted to the sharp type used and can be made small when a needle type sharp is utilized.
  • the attachment between sealer and capping can be made with any known method, e.g. permanently by for example gluing or welding or releasable by for example a push lock, threads etc.
  • the capping can be made as a single integral part or may consist of several discrete parts, e.g. with a separate locking ring, permitting slight capping engagement force while requiring high release force, with additional linings or gaskets, with separate film covering for integrity etc.
  • the capping material can be the conventional metal type, notably aluminum, but preferably comprises or consists of polymers for ease of manufacture and least contamination risks.
  • the connector part of the device in general terms includes a proximal part adapted for cooperation with the closure, a distal part adapted for connection to a secondary container or vessel and an intermediate part comprising at least the sharp.
  • the connector proximal part cooperation with the closure shall allow the connector to be axially movable in relation to the closure between at least two defined positions. In a first position the sharp is axially remote from the sealer so as not to pierce it and the connector bears on the closure so that an axial force applied to the connector is transmitted to an axial force on the closure. In a second position the sharp penetrates the sealer.
  • a releasable locking mechanism is arranged to prevent, when engaged, and to permit, when disengaged, movement of the connector from the first to the second position.
  • pressure may be applied directly to the closure for the purpose of bringing it to an engagement with the opening to establish sealing, a generally simpler sealing procedure is obtained if the pressure can be applied to the connector part.
  • any means may for bearing on the closure. Friction between the parts may be used, e.g. by radially pressing connector parts, such as a sleeve pushed over a similarly shaped closure part, against each other, which allows for force transmission with only axially arranged abutting surfaces.
  • the locking mechanism may include means for providing and releasing respectively said radial compression between the parts, e.g. a compression/expansion ring or wedges acting on slits, possibly cooperating with resilient parts. It is generally preferred, however, to provide both the closure and the connector with abutting surfaces, having at least a component perpendicular to the axis, such as either flat, inclined or curved. When abutted, such surfaces may safely transmit even strong forces.
  • the abutment may either be direct, as when the surfaces on closure and connector are contacted, or indirect, as when a separate member is positioned between and in contact with the surfaces on closure and connector.
  • the locking mechanism may here include means for axially aligning and disaligning respectively the surfaces.
  • the connector part preferably the connector part, or a separate member when present, radially away from engagement with the corresponding surface on the other part, e.g. by placing the surface bearing parts on flexible or removable tongues which may be manually influenced.
  • Another option is to place the surfaces, preferably inclined, on a resilient part or support in such a way that at a certain axial force the resilient part yields to allow the surfaces to ride out of engagement in a push lock manner.
  • the resilient part should be adapted to sustain the sealing step force but be overridden by a larger force in the connecting step.
  • Still another and preferred option is to align and disalign the surfaces by a relative rotation between closure and connector, which method is safe, yet convenient to the user.
  • One implementation of this option is to provide at least one, preferably several and most preferably a number of evenly and circumferentially distributed alternating surfaces and spaces on both the closure and connector parts in such a way that in certain angular positions the surfaces overlap and in other angular positions the surfaces can cross each other through the spaces. It is sufficient that the parts comprises a flange or rim part with the alternating structures, provided no device details behind interferes with the desired axial displacement, which sufficiency may be utilized to allow for angular dislocations of the parts after crossing of the surfaces, e.g. for final locking after completed axial displacement.
  • the surfaces and spaces on at least one of the parts may be extended to longitudinal ridges and grooves, for example in order to completely guide the parts during the movement from the first to the second position, which does not exclude a similar final locking in the second position.
  • the requirement that after releasing the locking mechanism the parts shall be able to axially displace in relation to each other, as well as the option of guiding the parts applies with equal significance to the other embodiments mentioned.
  • the movement from the first to the second position is substantially axial for reasons already given.
  • a preferred general outline for these purposes is to arrange the closure and connector parts in a telescopic manner, preferably with the connector part outermost.
  • the locking mechanism can be biased towards a default position, preferably towards the locked position preventing sharp penetration, by any known means, either reversibly by a resilient part or a spring or irreversibly through a rupturable member.
  • the proximal connector part may be designed with other optional features. It may be desirable to provide an additional locking between closure and connector designed to prevent axial separation of these parts. This in order for example to avoid unintentional disassembly, to assist in treating these parts as a unity or to maintain sterility.
  • the connection may be sealed, either by means of the mating parts themselves or by for example an additional adhered film or paste.
  • Another optional feature is to extend a shroud part of the connector over the closure, when exteriorly engaging the opening by a sleeve part, to act as a protection or a locking ring for the closure.
  • the intermediate connector part should at least have a length corresponding to the axial distance for the sharp when penetrating the sealer or when going from the first to the second position plus a possible additional length corresponding to an axial movement for connection of the distal connector part to the secondary container or vessel.
  • the physical structure of the connector intermediate part is not critical and may for example be reduced to any spacer bridging said necessary length, and uniting the proximal and distal ends and in a manner permitting transmission of the desired force. It is preferred to make the part substantially closed, among others to maintain sterility and avoid contamination, and preferably with a substantially tubular form wherein the interior size and shape with advantage may be adapted to the exterior of the closure for simplest overall design.
  • the sharp can be of an known type able to open up the closure to give access to container interior and "sharp" shall be understood to cover devices in broad sense for these purposes.
  • the sharp may be the mating part of a valve mechanism in the opening, a pusher for opening a one-way valve, a pusher for displacing e.g. a stopper or plunger into the container or to a non-sealing section on the stopper or container, a member displacing a sealing part of the closure such as a sealing pin, a part deforming a sealer into a non-sealing form etc.
  • the flow channel may be provided by a part separate from the sharp, e.g.
  • a duct surrounding the sharp or the connector itself may act as the channel when it has a closed design.
  • the sharp could open the closure in a manner allowing flow around sharp exterior, e.g. by having a non-uniform exterior.
  • the sharp not only performs penetration but also provides the flow channel for which purpose the sharp should contain at least one channel with one opening placed so as to be positioned within the container after the penetration step and the other opening outside the container and preferably ending so as to allow conduit connection to the secondary devices.
  • Two or more channels may be provided in an known manner, e.g. for allowing liquid flow in one channel and gas pressure equalizing through the other.
  • One preferred sharp is the needle-type designed as conventional in metal but preferably in a plastic.
  • the sharp is positioned within the intermediate part in a manner admitting closure penetration at an axial movement.
  • the sharp can be arranged slideably within the connector for example on a piston or movable wall type carrier or in any other known way as exemplified in the introduction. It is preferred, however, to affix the sharp to the connector allowing it to be axially displaced together with the connector. It may still be allowed to rotate relative the connector housing, e.g. to even out rotational movements of the connector housing, to allow separate locking of the sharp part, to perform an opening deformation on a closure or to assist in locking the secondary containers or vessels.
  • the sharp is preferably fixed to the connector also in respect of rotational movements.
  • a preferred construction is to arrange a wall across and substantially perpendicular to the device axis to which wall the sharp is attached, preferably substantially centrally.
  • the distance between the wall and the closure should be sufficient to allow the axial movement during penetration and may preferably act as a final stop for that movement.
  • the wall can be perforated, for example to allow venting of the proximal volume e.g. during evacuation, or can be continuous or sealed, for example to maintain sterility or to prevent any fluid communication but through the sharp channel.
  • the connector distal part for connection to secondary devices should at least comprise conduit completion means for the flow between the primary and secondary containers as exemplified but may with preference also comprise fixation means for physical attachment of the secondary device. These means may need adaptation to the specific secondary device to be received, either by modification of the distal connector part itself or by use of separate and different inserts or adapters for use with the same main connector design.
  • the secondary devices can be any of the types enumerated for use as primary devices but may also a simple tube, duct or catheter.
  • the conduit completion means may be another sharp in case the secondary device has a pierceable sealer, a female luer taper or other needle connector part in case of a syringe type secondary device, a push pin in case of one way valve mechanism, a thread in case of screw type opening etc.
  • Such conduit completion means should have fluid communication with the sharp part and may preferably be designed integral therewith.
  • conduit completion is attained by an axial movement relative the secondary device although an angular movement component may also be present as when threads are part of the means.
  • the sharp When the sharp is fixed to a transverse wall as described it is preferred that the sharp extends therefrom towards the proximal device end and that the conduit completion means extends from the wall in the opposite direction towards the connector distal end, whereat said wall may act also as a stop for the secondary device at reception thereof. If the conduit completion means does not provide physical fixation for the secondary device the abovesaid additional fixation means may be included, which preferably are located at the connector main housing rather than at the conduit completion means.
  • the fixation means may include any known type of fit, such as friction by wedging surfaces or otherwise, threads, bayonet, push lock, undercut, camming surfaces etc.
  • connection is made so that the secondary device opening axis, as defined, becomes oriented substantially coaxial with the primary container opening axis.
  • Other orientations are conceivable, however, for example more or less laterally in relation to connector axis e.g. to meet special administration demand situations or to avoid that the connection requirements for the secondary device interferes with the optimal design of the connector distal end for other purposes.
  • the connector distal end is made so that it can securely receive a flat force coaxial with the device for transmission to the closure part.
  • the distal end preferably has surface components transversal to the device axis and most preferably substantially symmetrically arranged to avoid twist and tilt, although conceivable that the force is applied via an equalizing intervening part.
  • the openings for the secondary device can be closed off before the connecting operation, e.g. by a cover or preferably a tearable or rupturable membrane.
  • the main device parts can be made in metal but are preferably manufactured in a plastic such as ABS, polycarbonate or preferably polypropylene and optionally the plastic materials contains a fiber reinforcement of for example glass. For cost efficiency, handling and assembly reasons it may be desirably to manufacture the device in as few pieces as possible. In broad terms at least the closure and the connector are manufactured as separate parts.
  • the device parts including a capping, sealer, connector, sharp and possible sealing membranes are preassembled and possibly sterilized.
  • the primary container with a pharmaceutical preparation content is placed in a chamber and the preassembled unit is positioned coaxial on top of the container in a resting position allowing gas exchange with the container interior.
  • a sterilizing step can be conducted with irradiation, heat, oxidizing gas etc., optionally with over or underpressure, the gas exchange also allowing evening out of pressure differences.
  • Another useful chamber process is a lyophilizing step on an initially liquid preparation, which may include cooling to freezing temperatures, chamber evacuation to create vacuum, preparation drying under moisture release and evacuation and oxygen purge or introduction of an inert gas overlay of for example nitrogen.
  • Closing and sealing of the container can now take place by pressing the device unit towards the container, which will result in that the sealer is brought to or into the container opening, the capping is engaged and locked to the opening, possibly also resting with its lower end on a shoulder part of the container, and location of the connector in position for connection.
  • This step is preferably made within the chamber by compression of the shelves on which containers with device units are standing.
  • the chamber may now be pressure equalized and opened.
  • the combined sealed container and connector can from now on be treated as an inseparable unit during optional post-treatment, transport, storage or other handling up to the connection thereof to a secondary device.
  • the operator removes or ruptures any sealing at the connector distal end and any similar sealing on the secondary part to be received.
  • the operator can decide either first to open the fluid connection to the primary container or the secondary device or both simultaneously by influencing the locking mechanism, by rotation or any of the other movements described, and axially compressing the relevant parts.
  • the operator releases the locking mechanism and pushes the connector part towards the container for penetration of the sharp and then introduces and pushes or threads, as the case may be, the secondary device opening into the distal connector part.
  • the reverse connection sequence is equally possible.
  • a substantially simultaneous connection may be obtained by for example first releasing the locking mechanism, but not compressing container and connector, then inserting the secondary device into the connector and compressing the secondary device relative the primary container to axially displace both the connector towards the primary container and the secondary device towards the connector.
  • the devices are pre-treated with over or underpressure to assist fluid flow, it is assumed that the operator actively orient the devices and take any other necessary measure to secure the desired flow.
  • the primary container contains a lyophilized solid or syrup and a residual vacuum from the lyophilizing step and the secondary device is a bag containing a solvent for the solid.
  • the operator first connects the bag to the connector to create a fluid communication therewith, then releases the locking mechanism and pushes the connector towards the primary container to pierce the closure with the sharp and establish fluid communication also here.
  • the vacuum in the container will now suck solvent from the bag into the container to dissolve the solid.
  • the operator may turn the entire aggregate of connected parts to a position with the primary container high and allow the solution to drain down into the bag for mixing with the main volume thereof and for subsequent administration of the combined preparations to a patient.
  • Figures 1A, 1B and 1C show in section an embodiment of the device in three different positional stages relative a container in plan view.
  • Figure 2A shows a top plan view of the closure from Figure 1 and Figure 2B shows a bottom plan view of the connector from Figure 1.
  • FIGS 3 to 6 show in schematic form alternative locking mechanism principles.
  • Figure 7 shows schematically a connector with alternative distal connecting means.
  • Figure 8 shows schematically a connector design with a movably arranged sharp.
  • FIG. 1A to 1C position 1 indicates a rigid bottle with an attached device according to the invention.
  • Bottle 1 has a neck 2, a rim 3 and an opening 4.
  • a closure member 5 comprises a pierceable sealer 6 of stopper type, having a cylindrical part 7, adapted to the opening interior, with a cavity 8 for limitation of necessary needle penetration, and a flange part 9 for abutment against bottle rim 3.
  • Closure 5 further comprises a capping 10, having a substantially cylindrical sleeve part 11, with internal rest and lock projections 12, and a closing top surface 13, with a hole 14 for needle penetration.
  • a connector 15 comprises a cylindrical housing 16, having a proximal end 17, with an internal flange part 18 for rest against the top surface 13 of capping 10, an intermediate part 19, with a fix wall 20 carrying a sharp in the form of a hollow needle 21, and a distal end 22 for pressure application and connection to a secondary vessel. Stopper 6 is attached to the capping 10 to form a closure 5 unit and connector 15 and closure 5 are united by friction to form a device assembly. A locking mechanism between closure 5 and connector 15 is not shown but will be described in relation to Figure 2.
  • Figure 1A shows an initial stage in which the device assembly has been placed on bottle 1 so that stopper 6 cylindrical part 7 only partially extends into bottle 1 opening 4 and without contact between flange 9 and rim 3.
  • the sleeve part 11 of capping 10 rests on rim 3 in a first push lock position stabilized by first and second projections 12 above and under rim 3.
  • the positions in this stage may be useful when communication between bottle interior and surroundings is desirable, as for any of the purposes previously described, and to assure such a communication lateral openings (not shown) may be present for example in sleeve 11 of capping 10 and in cylindrical part 7 of stopper 6.
  • the not shown locking mechanism between closure 5 and connector 15 is assumed to be in the locked state that prevents axial displacement of connector 15 in relation to closure 5.
  • FIG. 1B shows a second stage in which such a pressure has brought the device assembly as a whole down towards the bottle 1 and in which position the closure is in full engagement with bottle opening 4.
  • Stopper 6 cylindrical part 7 is fully accommodated in opening 4 and its flange 9 in contact with bottle rim 3.
  • Capping 10 is in a second push lock position stabilized by third and fourth projections 12 above and under rim 3.
  • the push lock and stopper friction may be sufficient for final retention of the closure but if desired additional means may be used such as a crimp under rim 3, a locking ring preventing sleeve 11 from flexing out or the push lock engagement or any other means.
  • Figure 1C shows a stage in which the locking mechanism has been disengaged to allow relative axial displacement between connector 15 and closure 5 and such a displacement has taken place to let needle 21 pass through hole 14 and penetrate stopper 6 upper part into cavity 8 to establish fluid communication.
  • a second container, syringe or duct may now be attached to the distal end 22 of connector 15.
  • Figure 2 shows a preferred locking mechanism for the device of Figure 1.
  • Figure 2A is a top plan view of closure 5 with its closing top surface 13 and hole 14 for needle 21. At regular intervals along the closure periphery are recesses or cut-outs 23 extending axially along sleeve 11 a distance at least corresponding to the desired movement between the two defined positions for the connector 15 and ending in shelves 24.
  • Figure 2B is a bottom plan view of the connector 15 with cylindrical housing 16, proximal end 17, flanges 18, wall 20 and needle 21. The diameter of inner surface 25 corresponds to the outer surface size of closure 5, allowing it to slide over the closure.
  • the flanges 18 projects inwardly from inner surface 25 a bit up from proximal end 17, to permit an initial engagement between closure and connector, and are distributed and sized in a manner corresponding to the recesses 23 of closure 5.
  • By relative rotation between these parts flanges 18 and recesses 23 may be brought either in alignment or disalignment.
  • disaligned flanges 18 rests on capping top surface 13 between the recesses 23 and the connector cannot be displaced further towards the capping but may transfer a pressure applied at its distal end 22 to capping 5.
  • aligned flanges 18 may travel along recesses 23 to allow connector 15 to approach capping 5 in the sharp penetration step until wall 20 abuts the capping top surface 13 or until flanges 18 abut shelves 24. Additional optional features may be included on the parts, e.g. a lock for the connector 15 at the end of its travel for example lateral undercuts close to the shelves for slightly hook shaped flanges or means for giving distinct stops at the aligned and disaligned positions respectively.
  • Figures 3 to 6 show in schematic form alternative locking mechanism principles.
  • the main parts shown is a closure 5 and a connector 15 with sleeve 11 and sharp 21 attached to rigid wall 20.
  • the embodiment of Figure 3 relies on friction for locking and a locking ring 30 is arranged to compress the lower part of sleeve 11 against closure 5, which may take place by locking ring resilience, by slightly conical ring or sleeve surfaces or in any other way.
  • To facilitate compression lower part of sleeve 11 may be axially slitted.
  • a number of tongues 40 or a continuous flange extends inwardly from the inner wall of sleeve 11.
  • the tongues normally bears on top surface 13 of the closure 5 and are rigid enough to sustain the necessary pressure for pushing the closure into engagement with the container but are designed to yield under higher pressure to a second position indicated at 41, allowing the connector to move into its second position.
  • a device is not identical to the claimed device it is useful in the claimed method.
  • similar tongues 50 are arranged on arms 51 hinged to the sleeve 11. When the arms are flush with sleeve 11 the tongues 50 bear on closure 5, as shown in Figure 5A, but the arms 51 may be flexed out, as shown in Figure 5B, to free the connector for displacement relative closure 5.
  • arms 51 may be made manually but preferably the arms are resilient and biased towards one of the positions, suitably to the open position shown in Figure 5B and may be retained in the closed position of Figure 5A by an axially displaceable ring or tearable strip 52.
  • similar tongues 60 are provided on an openable or tearable strip 61 with a generally T-shaped cross-section.
  • the strip 61 is removed to allow relative displacement between connector 15 and closure 5.
  • Figure 7 shows schematically how the distal end 22 of connector 15 can be redesigned depending on the nature of the secondary vessel to be connected.
  • the double-tipped needle 21 of the previous embodiments is replaced with a single needle 71 in the proximal end of the connector and ending in a luer taper 72 formed in the wall 73 e.g. to receive a syringe with a corresponding luer.
  • Figure 8 shows schematically a connector having a substantially cylindrical sleeve part 81 in which a slideable wall 82 is arranged carrying a sharp 83.
  • the wall is locked in position by pegs 84 penetrating the sleeve 81 and at least partly into the wall 82 and being accessible from the sleeve 81 outside.
  • Other locking means such as similar to those shown in Figures 2 to 6, can be used.
  • the device as shown may carry pressure from its distal end to closure 5.
  • the locking means provides at least two defined position for the sharp and allow the connecting sequence to be controlled, e.g.
  • connection to the secondary vessel with retained locking means by first making the connection to the primary container by removal of the lock and pushing of wall 82 towards the container or substantially simultaneously by removal of the lock and axial compression of container and vessel.

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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)
  • Making Paper Articles (AREA)
  • Secondary Cells (AREA)
  • Auxiliary Devices For And Details Of Packaging Control (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Claims (49)

  1. Vorrichtung zum Abdichten oder Verbinden eines Behälters, der zumindest eine Öffnung mit einer Öffnungsachse aufweist, die (a) ein Verschlusselement zur Anordnung in, an oder um die Öffnung, welches zumindest einen perforierbaren Abschnitt aufweist, (b) einen Verbinder, der, wenn er zumindest teilweise koaxial mit der Öffnung ausgerichtet ist, mit einem proximalen Ende an dem Verschluss und mit einem distalen Ende direkt oder indirekt an einem Gefäß in Form eines zweiten Behälters, einer Spritze oder einer Leitung anbringbar ist, und (c) einen scharfen Gegenstand umfasst, der dafür ausgelegt ist, zumindest den perforierbaren Abschnitt zu durchstechen und eine Fluidverbindung zwischen dem Behälter und dem Gefäß herzustellen, wobei
    der scharfe Gegenstand mit dem Verbinder verbunden oder integral mit diesem ausgeformt ist, um ihm zumindest in seinen axialen Bewegungen zu folgen, und
    der Verbinder in Bezug auf den Verschluss zwischen zumindest zwei definierten Positionen axial bewegbar ist, wobei die Positionen umfassen:
    (i) eine erste Position, in der der scharfe Gegenstand axial von dem Verschluss entfernt ist, um ihn nicht zu durchstechen, und in der der Verbinder direkt oder indirekt an dem Verschluss anliegt, so dass eine auf den Verbinder ausgeübte Längskraft auf eine auf den Verschluss wirkende Längskraft übertragen wird, und
    (ii) eine zweite Position, in der der scharfe Gegenstand den Verschluss durchsticht,
    gekennzeichnet durch einen lösbaren Rastmechanismus, der dafür ausgelegt ist, eine Bewegung des Verbinders von der ersten in die zweite Position in verrastetem Zustand zu verhindern und in unverrastetem Zustand zuzulassen, und dafür, ein Entrasten vor der Bewegung des Verbinders zu ermöglichen.
  2. Vorrichtung nach Anspruch 1,
    dadurch gekennzeichnet, dass der Verschluss eine zur Öffnungsachse transversale Oberflächenkomponente hat.
  3. Vorrichtung nach Anspruch 1,
    dadurch gekennzeichnet, dass die allgemeine Bauart des Verschlusses einen sich im wesentlichen axial erstreckenden Muffenabschnitt und eine obere Verschlussfläche umfasst.
  4. Vorrichtung nach Anspruch 3,
    dadurch gekennzeichnet, dass das Muffenstück so ausgeführt ist, dass es mit der Außenfläche einer Öffnung, welche ein Rohroder Halsstück aufweist, in Eingriff kommt.
  5. Vorrichtung nach Anspruch 1,
    dadurch gekennzeichnet, dass der Verschluss Mittel zur physischen Befestigung an der Öffnung aufweist.
  6. Vorrichtung nach Anspruch 5,
    dadurch gekennzeichnet, dass die Befestigungsmittel Mittel zur Befestigung in einer Vor-Dichtposition und in einer Dichtposition umfassen.
  7. Vorrichtung nach Anspruch 1,
    dadurch gekennzeichnet, dass der Verschluss den perforierbaren Abschnitt in Form einer perforierbaren Dichteinrichtung umfasst und ferner einen Abdeckungsabschnitt aufweist, der dafür ausgelegt ist, die Dichteinrichtung gegen Verschiebung von der Öffnung zu sichern.
  8. Vorrichtung nach Anspruch 7,
    dadurch gekennzeichnet, dass die Dichteinrichtung eine Membran oder Trennwand umfasst.
  9. Vorrichtung nach Anspruch 7,
    dadurch gekennzeichnet, dass die Dichteinrichtung einen Stopfen oder Pfropfen zur zumindest teilweisen Einführung in die Öffnung umfasst.
  10. Vorrichtung nach Anspruch 7,
    dadurch gekennzeichnet, dass die Abdeckung dafür ausgelegt ist, an der Außenfläche der Öffnung zumindest teilweise mit der Öffnung in Eingriff zu kommen.
  11. Vorrichtung nach Anspruch 1,
    dadurch gekennzeichnet, dass der Verbinder dafür ausgelegt ist, durch Reibung an dem Verschluss anzuliegen, und dass der Rastmechanismus Mittel umfasst, um Reibung bereitzustellen und die Reibung zu verringern bzw. zu beseitigen.
  12. Vorrichtung nach Anspruch 1,
    dadurch gekennzeichnet, dass der Verbinder dafür ausgelegt ist, über dazwischenliegende Stoßflächen an dem Verschluss anzuliegen, welche zumindest eine senkrecht zur Achse verlaufende Komponente aufweisen.
  13. Vorrichtung nach Anspruch 12,
    dadurch gekennzeichnet, dass der Rastmechanismus Richtmittel zum Ausrichten bzw. Verschieben der Oberflächen umfasst.
  14. Vorrichtung nach Anspruch 13,
    dadurch gekennzeichnet, dass die Richtmittel dafür ausgelegt sind, die Stoßflächen lateral zur Achse zu bewegen.
  15. Vorrichtung nach Anspruch 13,
    dadurch gekennzeichnet, dass die Richtmittel dafür ausgelegt sind, die Stoßflächen wechselseitig zumindest teilweise um die Achse zu drehen.
  16. Vorrichtung nach Anspruch 1,
    dadurch gekennzeichnet, dass die sich axial erstreckenden Abschnitte der Abdeckung und des Verbinders in teleskopischer Weise miteinander verbunden sind.
  17. Vorrichtung nach Anspruch 1,
    dadurch gekennzeichnet, dass der scharfe Gegenstand ein Gegenstück eines in der Öffnung befindlichen Ventilmechanismus, ein Stößel zum Öffnen eines Ein-Weg-Ventils, ein Stößel zum Verschieben z.B. eines Stopfens oder Pfropfens in den Behälter oder zu einem nicht-dichtenden Abschnitt des Stopfens oder Behälters, ein einen Dichtabschnitt des Verschlusses verschiebendes Element, wie etwa ein Dichtstift, oder ein eine Dichteinrichtung in eine nicht-dichtende Form verformendes Element ist.
  18. Vorrichtung nach Anspruch 1,
    dadurch gekennzeichnet, dass der scharfe Gegenstand eine Nadel umfasst.
  19. Vorrichtung nach Anspruch 1,
    dadurch gekennzeichnet, dass der scharfe Gegenstand einen Kanal zur Herstellung einer Fluidverbindung umfasst.
  20. Vorrichtung nach Anspruch 1,
    dadurch gekennzeichnet, dass der scharfe Gegenstand zumindest axial im Verbinder fixiert angeordnet ist.
  21. Vorrichtung nach Anspruch 1,
    dadurch gekennzeichnet, dass das distale Ende des Verbinders Kanalerweiterungsmittel für die Strömung zwischen Behälter und Gefäß umfasst.
  22. Vorrichtung nach Anspruch 1,
    dadurch gekennzeichnet, dass das distale Ende des Verbinders Mittel zur physischen Befestigung des Gefäßes umfasst.
  23. Verfahren zum Abdichten und Verbinden eines Behälters, der zumindest eine Öffnung mit einer Öffnungsachse aufweist, mit einem Gefäß in Form eines zweiten Behälters, einer Spritze oder einer Leitung,
    dadurch gekennzeichnet, dass es die Schritte umfasst:
    Positionieren eines Verschlusses, der zumindest einen perforierbaren Abschnitt aufweist und dafür ausgelegt ist, den Behälter zu verschließen, wenn er relativ zu dem Behälter in eine Eingriffsstellung gedrückt wird, in, an oder um die Öffnung im wesentlichen koaxial mit der Öffnung, jedoch distal von der Eingriffsstellung verschoben,
    Anlegen eines Verbinders, der einen scharfen Gegenstand umfasst, welcher dafür ausgelegt ist, zumindest den perforierbaren Abschnitt zu durchstechen und eine Fluidverbindung zwischen dem Behälterinneren und der Umgebung herzustellen, direkt oder indirekt an den Verschluss zur Übertragung von Längskräften,
    Ausüben eines Axialdruckes auf den Verbinder, um den Verbinder und den Verschluss zum Behälter zu bewegen und den Verschluss relativ zum Behälter in die Eingriffsstellung zu drücken, und
    Bewegen des scharfen Gegenstandes zum Behälter, um den perforierbaren Abschnitt zu durchstechen und die Fluidverbindung herzustellen.
  24. Verfahren nach Anspruch 23,
    dadurch gekennzeichnet, dass es den Schritt des Vormontierens des Verschlusses und des Verbinders und des Durchführens der Positionier- und Anlegeschritte durch Anordnen der vormontierten Teile als Einheit relativ zum Behälter umfasst.
  25. Verfahren nach Anspruch 23,
    dadurch gekennzeichnet, dass der Verschluss den perforierbaren Abschnitt in Form einer perforierbaren Dichteinrichtung und einen Abdeckungsabschnitt umfasst, der dafür ausgelegt ist, die Dichteinrichtung gegen Verschiebung von der Öffnung zu sichern.
  26. Verfahren nach Anspruch 25,
    dadurch gekennzeichnet, dass es den Schritt des Vormontierens und Zusammenhaltens der Dichteinrichtung mit der Abdichtung und das Bewegen der Dichteinrichtung zusammen mit der Abdeckung während zumindest einem der Schritte umfasst.
  27. Verfahren nach Anspruch 25,
    dadurch gekennzeichnet, dass es den Schritt des Anlegens zumindest der Abdeckung an den Behälter während zumindest eines Teils des Positionierschritts umfasst.
  28. Verfahren nach Anspruch 23,
    dadurch gekennzeichnet, dass es den Schritt des Sicherstellens von Fluidaustauschbedingungen zwischen dem Behälterinneren und der Umgebung zumindest für einen gewissen Zeitraum zwischen dem Positionieren des Verschlusses und dem Ausüben von Druck umfasst.
  29. Verfahren nach Anspruch 28,
    dadurch gekennzeichnet, dass es den Schritt des Durchführens eines Sterilisationsschrittes unter den Fluidaustauschbedingungen umfasst.
  30. Verfahren nach Anspruch 28,
    dadurch gekennzeichnet, dass es den Schritt des Durchführens eines Gefriertrocknungsschrittes unter den Fluidaustauschbedingungen umfasst.
  31. Verfahren nach Anspruch 28,
    dadurch gekennzeichnet, dass es den Schritt des Aufbewahrens des Behälters in einer Behandlungskammer und das Durchführen des Druckausübungsschritts umfasst, wenn sich dieser in der Behandlungskammer befindet.
  32. Verfahren nach Anspruch 23,
    dadurch gekennzeichnet, dass es den Schritt des Durchführens einer relativen Axialverschiebung zwischen Verbinder und scharfem Gegenstand während des Schrittes des Bewegens des scharfen Gegenstandes umfasst.
  33. Verfahren nach Anspruch 32,
    dadurch gekennzeichnet, dass es den Schritt des Lösens einer zumindest axialen Verrastung des scharfen Gegenstands mit dem Verbinder vor der Axialverschiebung umfasst, um es dadurch dem scharfen Gegenstand zu ermöglichen, die Axialverschiebung auszuführen.
  34. Verfahren nach Anspruch 23,
    dadurch gekennzeichnet, dass es den Schritt des axialen Bewegens des Verbinders zusammen mit dem scharfen Gegenstand relativ zum Behälter während des Schrittes des Bewegens des scharfen Gegenstandes umfasst.
  35. Verfahren nach Anspruch 34,
    dadurch gekennzeichnet, dass es den Schritt des Durchführens dieser kombinierten Bewegung im wesentlichen in axialer Richtung ohne erhebliche Rotationskomponente umfasst.
  36. Verfahren nach Anspruch 34,
    dadurch gekennzeichnet, dass es den Schritt des Aufhebens der Anlagebeziehung zwischen Verschluss und Verbinder vor der kombinierten Bewegung umfasst, um dazwischen eine relative Axialbewegung zuzulassen.
  37. Verfahren nach Anspruch 36,
    dadurch gekennzeichnet, dass das Aufheben der Anlagebeziehung den Schritt einer Relativdrehung zwischen Verschluss und Verbinder umfasst.
  38. Verfahren nach Anspruch 36,
    dadurch gekennzeichnet, dass das Aufheben der Anlagebeziehung den Schritt des lateralen Verschiebens der Stoßflächen zwischen Verschluss und Verbinder umfasst.
  39. Verfahren nach Anspruch 23,
    dadurch gekennzeichnet, dass die Bewegung des Verbinders zusammen mit dem scharfen Gegenstand den Schritt des Verschiebens eines Randabschnitts des Verbinders über den Verschluss umfasst, um als Sperrring für diesen zu wirken.
  40. Verfahren nach Anspruch 23,
    dadurch gekennzeichnet, dass es den Schritt des Herstellens der Fluidverbindung durch einen Kanal in dem scharfen Gegenstand umfasst.
  41. Verfahren nach Anspruch 23,
    dadurch gekennzeichnet, dass es den Schritt des Verbindens des Gefäßes mit dem Verbinder zum Herstellen einer Fluidverbindung mit dem Behälterinneren umfasst.
  42. Verfahren nach Anspruch 41,
    dadurch gekennzeichnet, dass der Verbindungsschritt vor der Bewegung des scharfen Gegenstandes durchgeführt wird.
  43. Verfahren nach Anspruch 41,
    dadurch gekennzeichnet, dass der Verbindungsschritt nach der Bewegung des scharfen Gegenstandes durchgeführt wird.
  44. Verfahren nach Anspruch 41,
    dadurch gekennzeichnet, dass der Verbindungsschritt ungefähr gleichzeitig mit der Bewegung des scharfen Gegenstandes durchgeführt wird.
  45. Verfahren nach Anspruch 41,
    dadurch gekennzeichnet, dass der Verbindungsschritt das Durchstechen eines perforierbaren Gefäßelementes durch einen zweiten scharfen Gegenstand umfasst, der in Fluidverbindung mit dem ersten scharfen Gegenstand steht.
  46. Verfahren nach Anspruch 41,
    dadurch gekennzeichnet, dass es den Schritt des Bewegens des Gefäßes im wesentlichen koaxial mit der Öffnung umfasst.
  47. Verfahren nach Anspruch 41,
    dadurch gekennzeichnet, dass es den Schritt des Anbringens einer Spritze an dem Verbinder umfasst.
  48. Verfahren nach Anspruch 46 oder 47,
    dadurch gekennzeichnet, dass es den Schritt des Anbringens einer Verjüngung in Fluidverbindung mit dem scharfen Gegenstand umfasst.
  49. Verfahren nach Anspruch 41,
    dadurch gekennzeichnet, dass es den Schritt des Durchführens eines Wiederherstellungsschrittes nach dem Verbindungsschritt umfasst.
EP97932063A 1996-07-11 1997-06-18 Verfahren und vorrichtung zur abdichtung und zum anschliessen eines behälters Expired - Lifetime EP0915692B1 (de)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
SE9602749A SE9602749D0 (sv) 1996-07-11 1996-07-11 Method and device for sealting and connecting a container
SE9602749 1996-07-11
US2256296P 1996-07-24 1996-07-24
US22562P 1996-07-24
PCT/SE1997/001094 WO1998002129A1 (en) 1996-07-11 1997-06-18 Method and device for sealing and connecting a container

Publications (2)

Publication Number Publication Date
EP0915692A1 EP0915692A1 (de) 1999-05-19
EP0915692B1 true EP0915692B1 (de) 2002-08-28

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EP (1) EP0915692B1 (de)
JP (1) JP2000514677A (de)
AT (1) ATE222743T1 (de)
AU (1) AU3561297A (de)
DE (1) DE69715007T2 (de)
DK (1) DK0915692T3 (de)
ES (1) ES2183202T3 (de)
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AU1263600A (en) * 1998-11-17 2000-06-05 Novo Nordisk A/S Transfer device
WO2000028940A1 (en) * 1998-11-17 2000-05-25 Novo Nordisk A/S Medicament transferring device
US6474375B2 (en) 2001-02-02 2002-11-05 Baxter International Inc. Reconstitution device and method of use
US6948522B2 (en) 2003-06-06 2005-09-27 Baxter International Inc. Reconstitution device and method of use
AU2011286179B2 (en) * 2010-08-06 2016-05-05 Hospira Australia Pty Ltd Vial preparation method and system
US20120078215A1 (en) * 2010-09-28 2012-03-29 Tyco Healthcare Group Lp Two-piece vial transfer needle assembly
DE102014111035A1 (de) 2014-08-04 2016-02-04 Aap Biomaterials Gmbh Mischvorrichtung, insbesondere ausgebildet zum Mischen von Knochenzement
US11026863B2 (en) 2015-06-16 2021-06-08 Boehringer Ingelheim Vetmedica Gmbh Connecting and container system
TWI737616B (zh) 2015-06-16 2021-09-01 德商百靈佳殷格翰維美迪加股份有限公司 容器系統、容器系統之用法、連接配置、容器及帽狀蓋罩裝置之用法
DK3177259T3 (da) 2015-06-16 2020-03-23 Boehringer Ingelheim Vetmedica Gmbh Forbindelses- og beholdersystem
WO2019063772A1 (en) 2017-09-28 2019-04-04 F. Hoffmann-La Roche Ag BOTTLE CAP FOR LYOPHILIZATION BOTTLE AND METHOD FOR CLOSING A LYOPHILIZATION BOTTLE

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IE60235B1 (en) * 1986-09-18 1994-06-15 Kabi Pharmacia Ab "Connector and disposable assembly utilising said connector"
JPH021277A (ja) * 1988-03-31 1990-01-05 Fujisawa Pharmaceut Co Ltd 輸液容器
ES1016828Y (es) * 1991-02-22 1992-06-01 Instituto De Biologia Y Sueroterapia, S.A. Dispositivo para la transferencia de liquidos entre recipientes flexibles y viales.

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PT915692E (pt) 2003-01-31
ATE222743T1 (de) 2002-09-15
DE69715007D1 (de) 2002-10-02
WO1998002129A1 (en) 1998-01-22
DE69715007T2 (de) 2003-04-30
JP2000514677A (ja) 2000-11-07
EP0915692A1 (de) 1999-05-19
ES2183202T3 (es) 2003-03-16
DK0915692T3 (da) 2002-12-30
AU3561297A (en) 1998-02-09

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