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EP2155142B1 - Druckausgleichsvorrichtung, behälter und verfahren - Google Patents

Druckausgleichsvorrichtung, behälter und verfahren Download PDF

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Publication number
EP2155142B1
EP2155142B1 EP07748575.3A EP07748575A EP2155142B1 EP 2155142 B1 EP2155142 B1 EP 2155142B1 EP 07748575 A EP07748575 A EP 07748575A EP 2155142 B1 EP2155142 B1 EP 2155142B1
Authority
EP
European Patent Office
Prior art keywords
filter
pressure equalizing
equalizing device
fluid
receptacle
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.)
Active
Application number
EP07748575.3A
Other languages
English (en)
French (fr)
Other versions
EP2155142A1 (de
EP2155142A4 (de
Inventor
Elisabet Helmerson
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.)
Carmel Pharma AB
Original Assignee
Carmel Pharma 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
Application filed by Carmel Pharma AB filed Critical Carmel Pharma AB
Publication of EP2155142A1 publication Critical patent/EP2155142A1/de
Publication of EP2155142A4 publication Critical patent/EP2155142A4/de
Application granted granted Critical
Publication of EP2155142B1 publication Critical patent/EP2155142B1/de
Active legal-status Critical Current
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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096Combination of a vial and a syringe for transferring or mixing their contents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006Piercing means
    • A61J1/201Piercing means having one piercing end
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048Connecting means
    • A61J1/2055Connecting means having gripping means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2068Venting means
    • A61J1/2075Venting means for external venting
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2079Filtering means
    • A61J1/2082Filtering means for gas filtration

Definitions

  • the present invention concerns a pressure equalizing device comprising a fluid container, i.e. liquid and/or gas container, for attachment to a receptacle, such as a vial, to permit pressure equalization between the fluid container and the receptacle.
  • a fluid container i.e. liquid and/or gas container
  • a receptacle such as a vial
  • the present invention also concerns a receptacle comprising such a pressure equalizing device.
  • Some drugs must be dissolved or diluted before they are administered, which involves transferring a solvent from one container to a sealed vial containing the drug in powder or liquid form, by means of a needle for example. Drugs may be inadvertently released into the atmosphere in gas form or by way of aerosolization, during the withdrawal of the needle from the vial and while the needle is inside the vial if any pressure differential between the interior of the vial and surrounding atmosphere exists.
  • the pressure equalization device comprises a gas container in communication with the interior of the vial, which ensures that neither an increased pressure nor a vacuum can occur inside the vial when gas or liquid is injected into or withdrawn from the vial.
  • the gas container may be filled with cleaned or sterilized air prior to its use to ensure that the contents of the vial do not become contaminated with air-borne particles such as dust, pollen, mould or bacteria and other undesirable substances.
  • US 2007/106244 describes a vial adapter comprising a housing, the housing comprising an expandable chamber to contain a volume, an internal passage in communication with the expandable chamber, at least one opening in communication with the internal passage, and an access member integral with the housing.
  • a hollow spike comprising a proximal end is integral with the housing and a distal end.
  • the spike comprises a vent lumen open at the distal end and a fluid lumen open at the distal end, the vent lumen is in communication with the internal passage and the fluid lumen is in communication with the access member.
  • a first check valve restricts communication from the expandable chamber to the internal passage, and a second check valve restricts communication from the internal passage to the opening.
  • An object of the present invention is to provide an improved pressure equalizing device comprising a fluid container, i.e. gas and/or liquid container, for attachment to a receptacle, such as a vial, to permit pressure equalization between the fluid container and the receptacle.
  • a pressure equalizing device comprising the features of claim 1, which comprises a fluid container and a flow channel that is arranged to provide fluid communication into or out of the fluid container when the pressure equalizing device is attached to the receptacle.
  • the pressure equalizing device also comprises a fluid inlet that contains a one-way valve that permits fluid to flow into the fluid container via said fluid inlet and that prevents fluid from flowing out of the fluid container via said fluid inlet.
  • the pressure equalizing device also comprises filter-receiving means that are arranged to permit fluid flowing into or out of the fluid container to be filtered when the filter-receiving means comprises a filter.
  • the pressure equalizing device equalizes pressure in the fluid container and the receptacle by allowing filtered fluid to flow into or out of the receptacle depending on whether the pressure is temporarily greater in the fluid container or the receptacle.
  • the pressure equalizing device thereby provides a simple, closed system that allows for safe and reliable injection or withdrawal of substances, such as toxic drugs, into or out of a receptacle while at least minimizing, or eliminating the risk of the substances contaminating breathable air.
  • the filter-receiving means comprises a removable or non-removable filter.
  • a filter with the mesh size 0.2 ⁇ m may be used to remove substantially all particles and micro organisms of that size or larger.
  • the filter may be a sterilizing or aseptisizing filter, such as a particulate air filter, such as a high efficiency particulate air (HEPA) filter to remove gas-borne particles such as dust, pollen, mould or bacteria and thus eliminating or at least reducing the risk of such gas-borne particles from contaminating substances inside the vial.
  • HEPA high efficiency particulate air
  • the pressure equalizing device may comprise a plurality of filters of the same type or of different types.
  • the filter-receiving means are located upstream or downstream of the one-way valve in the fluid inlet, which permits fluid to be filtered as it flows into the fluid container when the filter-receiving means comprises a filter.
  • the filter-receiving means are located in the flow channel, which permits fluid to be filtered as it flows out of the fluid container into the receptacle when the filter-receiving means comprises a filter.
  • the fluid container is an air container.
  • the fluid inlet is arranged to be in communication with ambient, i.e. non-sterilized air. Since ambient air can be cleaned on site using a sterilizing or ascepticizing filter in the pressure equalizing device, neither a sterile environment, nor extra equipment, nor a supply of clean air is necessary to fill the fluid container with cleaned air.
  • the pressure equalizing device according to the present invention may therefore be filled or replenished with cleaned fluid almost anywhere, in a simple manner and at low cost.
  • the fluid container comprises a flexible portion, such as a bladder, i.e. a portion comprising a flexible or expandable material, whereby the volume of said portion can be increased by drawing fluid into the fluid container and decreased by withdrawing fluid from the fluid container.
  • the fluid container may however be at least partly constituted of a rigid, non-compressible material.
  • the one-way valve is integrally formed with the filter-receiving means or a filter.
  • the filter-receiving means is removable from the fluid container.
  • the pressure equalizing device comprises connecting means, such as a bayonet coupling, luer lock or snap fit mechanism, for attachment of the pressure equalizing device to an injector such as a syringe and/or connecting means, such as a snap fit mechanism for attachment of the pressure equalizing device to a receptacle.
  • connecting means such as a bayonet coupling, luer lock or snap fit mechanism
  • At least part of the fluid container is integrally formed with the connecting means, from the same material for example, whereby the material may be a thermoplastic material, such as polyethylene or polypropylene; acrylonitrile butadiene styrene (ABS), polycarbonate, polyester or any other suitable material.
  • the material may be a thermoplastic material, such as polyethylene or polypropylene; acrylonitrile butadiene styrene (ABS), polycarbonate, polyester or any other suitable material.
  • the fluid container is detachable from the connecting means.
  • the present invention also concerns a receptacle that comprises a pressure equalizing device according to any of the embodiments of the invention.
  • At least part of the pressure equalizing device is integrally formed with at least one component of the receptacle, such as its cap or sealing means.
  • the pressure equalizing device according to the present invention is intended particularly, but not exclusively for use as a pressure equalizing device during the preparation or administration of drugs.
  • FIG. 1 shows a pressure equalizing device 10 according to an embodiment of the invention prior to being attached to a vial 12 containing a solid, liquid or gaseous pharmaceutical, biological or veterinary substance.
  • the vial 12 is sealed by means of a cap 14 and/or an elastomeric stopper or membrane.
  • the pressure equalizing device 10 comprises a gas container 16 having a variable volume.
  • the gas container 16 comprises a first portion 16a, such as a plastic parabola coupled to the main body of the pressure equalizing device 10, which comprises a relatively rigid material and a second portion 16b comprising a relatively flexible material, such as a thin, transparent plastic film that is attached to the first portion 16a in a gastight manner.
  • the gas container 16 can be designed as a bellow which is compressible and extendable.
  • the volume of the gas container 16 can thereby be increased and decreased.
  • the device illustrated in figure 1 comprises a partly compressible gas container 16
  • the gas container 16 can comprise a cylinder and a piston arranged therein so as to enable the volume of the gas container to be changed.
  • the gas container 16 could be constituted by bellows that are manually expandable and contractible.
  • the gas container 16 illustrated in figure 1 is shown in a fully inflated state.
  • the thick dotted line in figure 2 illustrates the position of the flexible portion 16b when the gas container 16 is in an evacuated and thus fully deflated state.
  • the gas container 16 which may have a volume of 1 cm 3 or less, up to 1 litre or more, depending on the application or size of the receptacle, comprises at least one gas inlet 20 containing a one-way valve and filter-receiving means.
  • the pressure equalizing device 10 comprises connecting means 22, such as a snap fit mechanism for attaching the pressure equalizing device 10 to the neck of a vial 12, which is 1-4 cm in diameter for example and a volume of 50 cm 3 , whereby the volume of the gas container may be 50 cm 3 in its fully inflated state.
  • the pressure equalizing device 10 may of course be dimensioned to be attached to receptacles of any size and volume.
  • the pressure equalizing device 10 also comprises a flow channel 18 that is arranged to provide gas communication between the gas container 16 and the interior of the vial 12 when the pressure equalizing device 10 is connected to the vial 12.
  • Figure 1 also shows a syringe 26 that may be used to inject fluid into the vial 12 or to withdraw fluid therefrom.
  • Figure 2 shows the pressure equalizing device 10 shown in figure 1 when it has been detachably or non-detachably attached to the vial 12 and when the needle 26a of the syringe 26 has been inserted through the pressure equalizing device 10 into the interior of the vial 12.
  • the flow channel 18 of the pressure equalizing device permits gas to flow from the interior of the vial 12 into the gas container 16 or from the gas container 16 to the vial 12, and thereby equalizes the pressure in the interior of the vial 12 and in the gas container 16. Gas may enter the gas container 16 via the fluid inlet 20, however gas cannot exit the gas container 16.
  • FIG 3 shows the rigid, incompressible part 16a of the gas container 16 shown in figures 1 and 2 .
  • This part 16a of the gas container comprises the gas inlet 20 that contains a one-way valve 28 that permits gas to flow into the gas container 16 via the gas inlet 20 and that prevents gas from flowing out of the gas container 16 via the gas inlet 20.
  • the gas inlet 20 also comprises filter-receiving means 30 that are located upstream of the one-way valve 28.
  • the gas inlet 20 is arranged to be in communication with ambient air. When a filter is placed in the filter-receiving means 30 ambient air is filtered as it flows into the gas container 16.
  • the filter may be any suitable commercially available filter, such as a particulate air filter having a pore size of 0.2 ⁇ m.
  • the one-way valve 28 is integrally formed with filter-receiving means 30.
  • This integrated unit may be detachable or non-detachable from the gas container 16.
  • the gas container 16 also comprises a flow channel 18 that provides a gas communication channel into and out of the gas container 16.
  • the embodiment illustrated in figure 3 includes an integrated one-way valve 28 and filter-receiving 30 unit that is slidably mounted in the plastic parabola 16a of the gas container.
  • the one-way valve 28 comprises an elastic sheath 28a that is arranged to cover an opening 28b and to uncover the opening 28b in its open position.
  • the integrated one-way valve 28 and filter-receiving means 30 unit is pushed radially inwards in a direction towards the interior of the gas container 16, which causes the elastic sheath 28a to abut against a stopper 28c and retract, uncovering the opening 28b and allowing filtered air into the gas container 16.
  • the integrated one-way valve 28 and filter-receiving means 30 unit is arranged to be pushed radially outwards in a direction out of the gas container 16, whereby the elastic sheath 28a extends and covers the opening 28b preventing any more gas from entering the gas container 16 via the air inlet 20.
  • the one way valve 28 is arranged to draw ambient air through the filter 30 and out of the opening 28b into the gas container 16 when the pressure inside the gas container 16 falls below a predetermined pressure, such as atmospheric pressure in order to keep the pressure inside the vial 12 in equilibrium with the pressure on the exterior of the vial 12.
  • the one way valve 28 could be arranged to be opened and closed manually.
  • FIGs 4 and 5 show part of a pressure equalizing device 10 according to a second embodiment of the invention.
  • the pressure equalizing device comprises connecting means 22 for attachment to a receptacle and connecting means 23, namely a bayonet coupling, for attachment to an injector, such as a syringe, and a gas container 16 comprising a plastic parabola 16a and a flexible portion (not shown) that is attached to the plastic parabola 16a.
  • a filter may be placed in the filter-receiving means 30 to filter gas entering the gas container 16 via the air inlet 20 (that is hidden behind the filter-receiving means 30 in figures 4 and 5 ).
  • the filter-receiving means 30 are either integrally formed with the plastic parabola 16a of the gas container 16, by a blow moulding or vacuum forming process for example, or are attached to the inner surface of the plastic parabola 16a, by a continuous welding process, such as ultrasound welding, for example. Ultrasound is used to generate internal friction in the plastic of the parabola 16a and the filter-receiving means 30 and thereby heat the parabola 16a and the filter-receiving means 30. The heated surfaces are then joined together by application of pressure.
  • a filter may be permanently attached to the filter-receiving means 30 using ultrasound welding.
  • the filter and filter-receiving means 30 should be arranged to ensure that a flexible portion is substantially uniformly inflated so that no part of it is excessively stretched during the inflation thereof.
  • the filter may, for example, be arranged at an angle to the direction of incoming gas as shown in figures 4 and 5 , rather than being arranged perpendicularly to the direction of incoming gas.
  • a second filter-receiving means may be placed in the flow channel 18 to enable fluid passing between the vial 12 and the gas container 16 to be filtered.
  • Figure 6 shows an exploded view of part of a pressure equalizing device 10 according to a third embodiment of the invention.
  • the gas container 16 comprises a parabola 16a and a flexible portion 16b comprising a thin transparent film.
  • the gas container 16 comprises an air inlet 20 and a one-way valve 28 is located in the air inlet 20.
  • Figure 7 shows the pressure equalizing device 10 of figure 6 when in use. Gas flows into the gas container 16 in the direction of the arrows in figure 7 , namely through the openings in part 24 of the gas container 16, through a filter 34 into the air inlet 20 via radial channels and past the one-way valve 28 into the interior of the gas container 16.
  • the part 24 comprising the openings in the illustrated embodiment may be arranged to be removable from the gas container 16 or it may be fixedly attached thereto, by means of adhesion or welding for example.
  • Figure 7 shows that filter-receiving means 30 may be placed at the mouth of the flow channel 18 that provides gas communication into or out of the gas container and/or at any other position along the flow channel 18.
  • FIGS 8-10 show part of a pressure equalizing device 10 according to a fourth embodiment of the invention.
  • the pressure equalizing device 10 comprises a gas container comprising a parabola 16a and means 22 for connecting the pressure equalizing device 10 to an receptor.
  • the gas container 16 may be detachable from the connecting means 22.
  • the gas container 16 is for example attached to the connecting means 22 by means of a bayonet coupling or any other releasable coupling means.
  • Filter-receiving means 30 are placed in between the gas container 16 and the connecting means 22.
  • FIG. 11-13 show part of a pressure equalizing device 10 according to a fifth embodiment of the invention.
  • the pressure equalizing device 10 comprises a parabola 16a and connecting means 23 for attaching the pressure equalizing device 10 to an injector, such as a syringe.
  • the parabola 16a is integrally formed with the connecting means 22 and 23 in the illustrated embodiment.
  • the pressure equalizing device 10 comprises an insert 36 comprising filter-receiving means 30 and a one-way valve 28.
  • the insert 36 is removably or non-removably attached to the inside of the parabola 16a and may be provided with guiding means, to facilitate positioning of the filter-receiving means 30 in the flow channel 18 and/or the one-way valve 28 in the air inlet 20.
  • the gas container may be of any shape and size and may be located in any suitable position with respect to a receptacle when a pressure equalizing device is attached to a receptacle.

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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)

Claims (16)

  1. Druckausgleichsvorrichtung (10), welche einen Fluidbehälter (16) zur Anbringung an einem Gefäß (12) wie beispielsweise einer Phiole aufweist, um so einen Druckausgleich zwischen dem Fluidbehälter (16) und dem Gefäß (12) zu ermöglichen, wobei die Druckausgleichsvorrichtung (10) folgendes umfasst:
    • einen Strömungskanal (18), der so angeordnet ist, dass er für eine Strömungsverbindung in den Fluidbehälter (16) und aus diesem heraus sorgt, wenn die Druckausgleichsvorrichtung (10) an dem Gefäß (12) angebracht ist,
    dadurch gekennzeichnet, dass sie folgendes aufweist:
    • einen Fluideinlass (20), der ein Rückschlagventil (28) enthält, welches ein Fluid über den Fluideinlass (20) in den Fluidbehälter (16) einströmen lässt, und welches verhindert, dass ein Fluid über den Fluideinlass (20) aus dem Fluidbehälter (16) ausfließt, und
    • eine Filteraufnahmeeinrichtung (30), die so angeordnet ist, dass sie ein Fluid zur Filterung dann, wenn die Filteraufnahmeeinrichtung (30) einen Filter (34) enthält, in den Fluidbehälter einfließen oder aus diesem ausfließen lässt, je nachdem, ob der Druck zeitweise in dem Fluidbehälter oder dem Gefäß größer ist.
  2. Druckausgleichsvorrichtung (10) nach Anspruch 1, dadurch gekennzeichnet, dass die Filteraufnahmeeinrichtung (30) einen herausnehmbaren oder nicht-herausnehmbaren Filter (34) aufweist.
  3. Druckausgleichsvorrichtung (10) nach Anspruch 2, dadurch gekennzeichnet, dass der Filter (34) ein Sterilisierfilter oder aseptisch machender Filter, beispielsweise ein Feinstaub-Luftfilter wie z.B. ein Schwebstofffilter, ist.
  4. Druckausgleichsvorrichtung (10) nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass sich die Filteraufnahmeeinrichtung (30) anströmseitig oder abströmseitig von einem Rückschlagventil (28) in dem Fluideinlass (20) befindet, wodurch eine Filtrierung der Flüssigkeit beim Einfließen in den Fluidbehälter (16) ermöglicht wird, wenn die Filteraufnahmeeinrichtung (30) einen Filter (34) enthält.
  5. Druckausgleichsvorrichtung (10) nach einem der Ansprüche 1 bis 3, dadurch gekennzeichnet, dass sich die Filteraufnahmeeinrichtung (30) in dem Strömungskanal (18) befindet, wodurch eine Filtrierung der Flüssigkeit beim Ausfließen aus dem Fluidbehälter (16) in das Gefäß (12) ermöglicht wird, wenn die Filteraufnahmeeinrichtung (30) einen Filter (34) enthält.
  6. Druckausgleichsvorrichtung (10) nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass der Fluidbehälter (16) ein Luftbehälter ist.
  7. Druckausgleichsvorrichtung (16) nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass der Fluideinlass (20) so angeordnet ist, dass er in Strömungsverbindung mit der Umgebungsluft steht.
  8. Druckausgleichsvorrichtung (10) nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass der Fluidbehälter (16) einen elastischen Abschnitt (16b) aufweist.
  9. Druckausgleichsvorrichtung (16) nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass das Rückschlagventil (28) einstückig mit der Filteraufnahmeeinrichtung (30) oder mit einem Filter (34) ausgebildet ist.
  10. Druckausgleichsvorrichtung (10) nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass die Filteraufnahmeeinrichtung (30) von dem Fluidbehälter (10) lösbar ist.
  11. Druckausgleichsvorrichtung (10) nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass sie Verbindungsmittel (22) zur Anbringung der Druckausgleichsvorrichtung (10) an einem Gefäß (12) und/oder Verbindungsmittel (23) zur Anbringung der Druckausgleichsvorrichtung (10) an einer Einspritzvorrichtung wie beispielsweise einer medizinischen Spritze aufweist.
  12. Druckausgleichsvorrichtung (10) nach Anspruch 11, dadurch gekennzeichnet, dass zumindest ein Teil des Fluidbehälters (16a) einstückig mit den Verbindungsmitteln (22, 23) ausgebildet ist.
  13. Druckausgleichsvorrichtung (10) nach Anspruch 11, dadurch gekennzeichnet, dass der Fluidbehälter (16) von den Verbindungsmitteln (22, 23) lösbar ist.
  14. Gefäß, dadurch gekennzeichnet, dass er eine Druckausgleichsvorrichtung (10) nach einem der Ansprüche 1 bis 13 umfasst.
  15. Gefäß nach Anspruch 14, dadurch gekennzeichnet, dass zumindest ein Teil der Druckausgleichsvorrichtung (10) einstückig mit mindestens einem Bauteil des Behälters (12) ausgebildet ist.
  16. Verwendung des Druckausgleichsbehälters (10) nach einem der Ansprüche 1 bis 13 als Vorrichtung zum Druckausgleich während der Herstellung oder Verabreichung von Medikamenten.
EP07748575.3A 2007-06-13 2007-06-13 Druckausgleichsvorrichtung, behälter und verfahren Active EP2155142B1 (de)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/SE2007/050415 WO2008153459A1 (en) 2007-06-13 2007-06-13 Pressure equalizing device, receptacle and method

Publications (3)

Publication Number Publication Date
EP2155142A1 EP2155142A1 (de) 2010-02-24
EP2155142A4 EP2155142A4 (de) 2013-07-03
EP2155142B1 true EP2155142B1 (de) 2016-05-25

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Family Applications (1)

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EP07748575.3A Active EP2155142B1 (de) 2007-06-13 2007-06-13 Druckausgleichsvorrichtung, behälter und verfahren

Country Status (5)

Country Link
EP (1) EP2155142B1 (de)
JP (1) JP5059190B2 (de)
CA (1) CA2691284C (de)
ES (1) ES2586682T3 (de)
WO (1) WO2008153459A1 (de)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022103717A1 (en) 2020-11-10 2022-05-19 Becton, Dickinson And Company Vial adapter with air management device
US11801200B2 (en) 2017-11-10 2023-10-31 Simplivia Healthcare Ltd. Vial adaptor with housing

Families Citing this family (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7547300B2 (en) 2006-04-12 2009-06-16 Icu Medical, Inc. Vial adaptor for regulating pressure
FR2951638B1 (fr) * 2009-10-28 2012-05-25 Vygon Dispositif d'interfacage pour flacons a perforer
AU2012296495B2 (en) 2011-08-18 2016-03-10 Icu Medical, Inc. Pressure-regulating vial adaptors
EP3072494B1 (de) 2012-03-01 2017-10-18 Becton, Dickinson and Company Ltd. Druckausgleichende vorrichtung und behälter
WO2013142618A1 (en) 2012-03-22 2013-09-26 Icu Medical, Inc. Pressure-regulating vial adaptors
US9579258B2 (en) 2012-04-02 2017-02-28 Kobayashi & Co., Ltd. Drug delivery device
US9566215B2 (en) 2012-04-02 2017-02-14 Kobayashi & Co., Ltd. Drug delivery device
EP3753545A1 (de) 2012-06-27 2020-12-23 Carmel Pharma AB Medizinische anschlussvorrichtung
EP2735300A1 (de) 2012-11-26 2014-05-28 Becton Dickinson France Adapter für Multidosierungs-Medizinbehälter
WO2014116602A1 (en) 2013-01-23 2014-07-31 Icu Medical, Inc. Pressure-regulating vial adaptors
US9089475B2 (en) 2013-01-23 2015-07-28 Icu Medical, Inc. Pressure-regulating vial adaptors
CA2918381C (en) 2013-07-19 2023-01-17 Icu Medical, Inc. Pressure-regulating fluid transfer systems and methods
JP6605511B2 (ja) 2014-06-20 2019-11-13 アイシーユー・メディカル・インコーポレーテッド 圧力調整バイアルアダプタ
JP6389230B2 (ja) * 2016-11-28 2018-09-12 カルメル ファルマ アクチボラゲット 医療用接続装置
JP6992236B2 (ja) * 2017-09-11 2022-01-13 株式会社トップ 閉鎖式薬物移送システム
CN109998918A (zh) * 2019-04-26 2019-07-12 台州安融医疗器械有限公司 一种配药器
CN110812597A (zh) * 2019-12-09 2020-02-21 湖南平安医械科技有限公司 防脱落精密过滤型瓶塞穿刺器

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SE434700B (sv) * 1983-05-20 1984-08-13 Bengt Gustavsson Anordning for lufttet overforing av substans fran ett kerl till ett annat
JP3475414B2 (ja) * 1994-01-28 2003-12-08 ニプロ株式会社 混注用アダプター
SE513225C2 (sv) * 1998-12-03 2000-08-07 Carmel Pharma Ab Arrangemang, förfarande och gasbehållare för steril eller aseptisk hantering
SE517084C2 (sv) * 2000-08-10 2002-04-09 Carmel Pharma Ab Förfarande och anordningar vid aseptisk beredning
EP1951344B1 (de) * 2005-11-07 2014-05-28 Industrie Borla SpA Sicher zu bedienender, belüfteter phiolenadapter

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11801200B2 (en) 2017-11-10 2023-10-31 Simplivia Healthcare Ltd. Vial adaptor with housing
WO2022103717A1 (en) 2020-11-10 2022-05-19 Becton, Dickinson And Company Vial adapter with air management device
EP4243758A4 (de) * 2020-11-10 2024-08-21 Becton, Dickinson and Company Phiolenadapter mit luftverwaltungsvorrichtung

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CA2691284C (en) 2015-05-12
ES2586682T3 (es) 2016-10-18
WO2008153459A1 (en) 2008-12-18
JP5059190B2 (ja) 2012-10-24
JP2010528809A (ja) 2010-08-26
EP2155142A1 (de) 2010-02-24
CA2691284A1 (en) 2008-12-18
EP2155142A4 (de) 2013-07-03

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