Nothing Special   »   [go: up one dir, main page]

EP3009121B1 - Vorrichtung zur abgabe von flüssigkeiten an einen behälter - Google Patents

Vorrichtung zur abgabe von flüssigkeiten an einen behälter Download PDF

Info

Publication number
EP3009121B1
EP3009121B1 EP15198205.5A EP15198205A EP3009121B1 EP 3009121 B1 EP3009121 B1 EP 3009121B1 EP 15198205 A EP15198205 A EP 15198205A EP 3009121 B1 EP3009121 B1 EP 3009121B1
Authority
EP
European Patent Office
Prior art keywords
container
receptacle
gas
connector
volume
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
EP15198205.5A
Other languages
English (en)
French (fr)
Other versions
EP3009121A1 (de
Inventor
Elisabet Helmerson Lundahl
Fredrik BÄCKSTRÖM
Anna ELLSTRÖM
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
Priority to ES15198205.5T priority Critical patent/ES2627304T3/es
Priority to EP17170133.7A priority patent/EP3222265B1/de
Priority to EP15198205.5A priority patent/EP3009121B1/de
Publication of EP3009121A1 publication Critical patent/EP3009121A1/de
Application granted granted Critical
Publication of EP3009121B1 publication Critical patent/EP3009121B1/de
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—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
    • A61J1/2048—Connecting means
    • A61J1/2055—Connecting means having gripping means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—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
    • A61J1/2068—Venting means
    • A61J1/2075—Venting means for external venting
    • 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
    • A61J1/2079—Filtering means
    • A61J1/2082—Filtering means for gas filtration

Definitions

  • the invention relates to a device for providing cleaned fluid to a receptacle according to the preamble of claim 1.
  • the invention can be implemented in aseptic preparation of drugs, for example for providing sterilized/cleaned air to a medical receptacle, such as a bottle or vial, with the purpose of drawing a solution or another liquid used in medicine applications out from the medical receptacle.
  • a known problem associated with the preparation of drug solutions is the fact that medical bottles or vials normally are made of a non-compressible material, such as glass or plastic. To enable the vial to be drained off, air has to flow into the vial so as to avoid negative pressure in the vial which negative pressure would otherwise counteract or prevent further transportation of liquid from the vial to another receptacle such as syringe.
  • a system for providing sterilized gas is disclosed in WO 00/35517 .
  • a flexible bag containing sterilised gas is provided.
  • the bag has an opening covered by a gas and liquid-impervious membrane which can be punctured by a needle in order to draw the sterilised gas out from the bag for further transportation of the gas to a bottle.
  • a bottle connector is arranged on the current bottle and the bottle connector has a pressure compensation means for receiving gas.
  • WO 02/11794 a system for providing cleaned gas is described.
  • This system works with an injection syringe and an air filter to be attached to a connection nozzle of the syringe.
  • the container of the syringe is charged with air which has been forced through the filter so as to clean the air.
  • the air filter is removed and the syringe is connected to a coupling means (injector device) which in turn is connected to a capping means (bottle connector) arranged on a bottle.
  • the capping means has a pressure-equalisation chamber whose volume can vary.
  • the cleaned gas in the syringe is transferred from the syringe to the bottle and to the pressure-equalisation chamber arranged on the capping means. Thereafter the substance in the bottle can be drawn out from the bottle by means of the syringe and the coupling means, while the cleaned gas flows from the pressure-equalisation chamber into the bottle.
  • the prior art system described in WO 02/11794 has drawbacks.
  • the system requires an adapter provided with an air filter being connected to and removed from a syringe in order to fill the pressure-equalisation chamber before the medical substance can be drawn from the bottle.
  • the air filter is fixedly attached to a syringe.
  • a conventional syringe can not be used.
  • the cleaned gas has to be drawn from the environment and subsequently transferred to the bottle and the pressure-equalisation chamber before the medical substance can be drawn from the bottle.
  • An object of the invention is to provide a device for providing cleaned and/or sterilized fluid of the kind referred to in the introduction where at least one problem of such prior art devices discussed above is reduced to a substantial extent.
  • the invention aims to indicate how to provide sterilized/cleaned fluid in a rational and safe way during preparation of drugs.
  • the invention is based on the insight that sterilized/cleaned air is advantageously provided by a connector system itself, rather than utilising additional equipments to fill an expansion container comprised in a connector system during drug preparation.
  • the object is achieved by a device according to claim 1.
  • the device 1 can be used for providing cleaned and/or sterilized gas, for example air, to a receptacle and thereby facilitate conveyance of a substance out of the receptacle.
  • a substance can be various solutions and liquids constituting drugs, for example cytotoxic drugs and antibiotics, for use in the field of medicine.
  • the device comprises a connector 2 and a container 3 which form an integrated unit 4.
  • the connector 2 is provided with a first means 5 for connection to a receptacle or in other words a first connector portion 5 for connection to a receptacle.
  • the container 3 is pre-filled or adapted to be pre-filled with a cleaned and/or sterilized gas to be transferred from the container 3 to a receptacle, which is connectable with the connector 2, during conveyance of a substance out of the receptacle.
  • a medicine receptacle such as a bottle or vial 6, and the exploded view in figure 4 .
  • pre-filled is meant the container being already filled with gas before it is used for providing gas to a receptacle.
  • the device is suitably already filled when delivered to the user, and preferably the container is filled during or after manufacture of the device for example just before or at the moment when the device is enclosed by a package or packing.
  • cleaned gas is meant that the gas has been filtered by a filter to remove particles and/or viable micro-organisms to such an extent that the gas is classified to be aseptic and accepted by the relevant authority and/or any standards.
  • the degree of purity can be expressed in the largest particles allowed to pass the filter for a given flow rate of gas. In some cases no or very few particles having a size exceeding 5 ⁇ m are allowed to be present in the cleaned gas. However, the allowed particle size is determined by the requirements in the current application. Some drug treatments require that substantially all particles having a size exceeding 0.15 ⁇ m are removed from the gas by the particulate air filter. As an example, a filter with the mesh size 0.2 ⁇ m can be used to remove substantially all particles and micro organisms of that size or larger.
  • sterilized gas By the expression “sterilized” gas is meant that the gas has been subjected to a sterilization method to remove viable micro-organisms, which method is accepted for the current product by the relevant authority.
  • Current regulations in Europe for medical devices to be designated “STERILE” may be found in the European standard EN 556-1. Other regulations may exist in other countries.
  • the sterilization can be ethylene oxide sterilization, sterilisation by irradiation, or (moist) heat sterilization or any other accepted method.
  • the European standard requirements imply that the theoretical probability of there being a viable micro-organism present on/in the sterilized device shall be equal to or less than 1x10 -6 .
  • the gas is sterilized, it is not always necessary to clean the gas according to the cleaning process as described above, although such cleaning and the sterilization can be combined. However, other methods can be used to remove particles etc. from the gas if required or the sterilization process itself may be sufficient to bring the gas into a state where the gas is to be considered as both cleaned and sterilized.
  • the first connection means 5 can be designed for connection to a receptacle, such as the neck of a vial.
  • the first connection means 5 is constituted by a ring-shaped portion 7 for enclosing the neck 8 of the vial 6.
  • the ring-shaped portion 7 has slits 9 so as to form flanges 10 which protrude downwardly.
  • the flanges 10 can be provided with hooks 11 or barbs for gripping around the neck 8 of the vial 6.
  • the connector 2 is suitably provided with a second means 12 for connection to a transfer member 13 (see figures 3 and 4 ), such as an injector device to be interconnected with the connector, for conveyance of a substance out of the receptacle 6.
  • the connector 2 is suitably provided with a second connector portion 12.
  • the second connection means 12 can comprise a luer lock coupling or bayonet coupling to enable an injector device to be connected to the connector.
  • both the injector device and the connector are provided with a membrane so as to create a double membrane coupling between the injector and the current device.
  • the amount of gas, preferably air, provided by the pre-filled container should be adapted to the volume of the receptacle which is to be drained off.
  • the volume of the gas when being in the receptacle should preferably correspond to the volume of the receptacle so as to enable the receptacle to be completely drained off. This implies that the volume of the cleaned or sterilized gas in the pre-filled container is preferably approximately equal to or larger than the volume of the receptacle provided that the pressure of the gas is substantially the same in the receptacle as in the container.
  • the volume of the gas should be in the interval 1-100 cm 3 at atmospheric pressure.
  • the connector 2 is preferably provided with a piercing member, such as a hollow needle 14 (as illustrated) for penetration of a closing (not illustrated) made of rubber for instance, which closing covers the opening of a receptacle 6, such as a vial.
  • a piercing member such as a hollow needle 14 (as illustrated) for penetration of a closing (not illustrated) made of rubber for instance, which closing covers the opening of a receptacle 6, such as a vial.
  • the expression “needle” is meant to comprise spikes and similar components for penetration of such a closing in order to create a channel between the container 3 and the receptacle 6 to which the connector 2 is connected.
  • gas contained in the container 3 can be transferred from the container to the receptacle 6, i.e. gas can flow from the container 3 to the receptacle 6.
  • the connector 2 and the container 3 form an integrated unit 4. This implies that the connector and the container are made in one piece or the connector 2 and the container 3 can be coupled to each other so as to form an integral unit 4. Different types of coupling means known from prior art can be used as long as an airtight, or at least a substantially airtight connection can be obtained between the current components 2, 3.
  • the volume of the container 3 can be variable so as to allow the gas to flow from the container 3 to a receptacle 6.
  • the container 3 is suitably made of a compressible material to make the volume of the container variable.
  • the container can comprise a first portion 17 made by a relatively rigid material which first portion 17 is coupled to the connector 2, and a second portion 18 made by a relatively flexible material attached to the first portion 17.
  • the container 3 can be designed to have a flexible portion, such as a bellow which is compressible and extendable.
  • the container or the flexible portion of the container, comprises a displaceable spring-loaded element, such as an axial spring-loaded element, that is arranged to allow fluid to flow into the container/ flexible portion of the container.
  • the displaceable spring-loaded element is for example constrained between two flanged ends of the flexible portion.
  • the spring(s) of the spring-loaded element is/are highly compressed.
  • the spring(s) may be arranged on the inside or outside of the flexible portion or they may be integrally formed with the flexible portion.
  • the displaceable spring-loaded element may be arranged to be disconnected from the container/flexible portion of the container once the container/flexible portion of the container has been filled to the desired amount.
  • the flexible portion of the container may be arranged to be detachable from the remaining part of the container, whereby the flexible portion may be filled with fluid before and/or after it has been attached to the remaining part of the container.
  • the volume of the container 3 can be increased and decreased, respectively.
  • the device illustrated in figure 1 comprises a compressible container
  • the container can have a cylinder and a piston arranged therein so as to enable the volume of the container to be changed.
  • the container comprises locking means to prevent fluid from flowing into the container, during the transportation of the device, for example, or at any other time when the device is not in use.
  • the container 3 can be pressurized by cleaned or sterilized gas to cause an overpressure in the container.
  • An overpressure allows gas to flow from the container 3 to a receptacle 6 connected to the connector and the container.
  • the overpressure is suitably adapted to the size of the receptacle to which the connector is to be connected to ensure the receptacle can be completely drained off in a subsequent step.
  • the pressure in the filled container can be for example in the interval from 1atm to 2atm.
  • the device comprises any means, such as a valve, for allowing the gas to flow from the container after the device has been connected to the receptacle and during conveyance of a substance out of the receptacle.
  • a device 1' according to the invention is illustrated.
  • the device can be used for providing cleaned gas to a receptacle and thereby facilitate conveyance of a substance out of the receptacle.
  • a substance can be various solutions and liquids constituting drugs, for example cytotoxic drugs or antibiotics, for use in the field of medicine.
  • the device comprises a connector 2' and a container 3' which form an integrated unit 4'.
  • the connector 2' is provided with a first means 5' for connection to a receptacle 6' or in other words a first connector portion 5'. See also figure 7 illustrating the device connected to a medicine bottle or vial 6', and the exploded view in figure 8 .
  • the first connection means 5' can be designed for connection to a bottle, such as the neck of a vial.
  • the first connection means 5' is constituted by a ring-shaped portion 7' for enclosing the neck 8' of the vial 6'.
  • the ring-shaped portion 7' has slits 9' so as to form flanges 10' which protrude downwardly.
  • the flanges 10' can be provided with hooks 11' or barbs for gripping around the neck 8' of the vial 6'.
  • the connector 2' is suitably provided with a second means 12' for connection to a transfer member 13', such as an injector device to be interconnected with the connector, for conveyance of a substance out of the receptacle 6'.
  • a transfer member 13' such as an injector device to be interconnected with the connector, for conveyance of a substance out of the receptacle 6'.
  • the connector 2' is suitably provided with a second connector portion 12'.
  • the second connection means 12' can comprise a luer lock coupling or bayonet coupling to enable an injection device to be connected.
  • both the injector device and the connector are suitably provided with a membrane so as to create a double membrane coupling between the injector and the current device.
  • the connector 2' is preferably provided with a piercing member, such as a hollow needle 14' (as illustrated) for penetration of a closing (not illustrated) made of rubber for instance, which closing covers the opening of a receptacle 6, such as a vial.
  • a piercing member such as a hollow needle 14' (as illustrated) for penetration of a closing (not illustrated) made of rubber for instance, which closing covers the opening of a receptacle 6, such as a vial.
  • the expression “needle” is meant to comprise spikes and similar components for penetration of such a closing in order to create a channel between the container 3' and the receptacle 6' to which the connector 2' is connected.
  • a channel or passage 15' in the needle 14' gas contained in the container 3' can be transferred from the container to the receptacle 6', i.e. gas can flow from the container 3' to the receptacle 6'.
  • the connector 2' and the container 3' form an integrated unit 4'.
  • Different types of coupling means 16' known from prior art can be used as long as an airtight or at least a substantially airtight connection can be obtained between the current components 2', 3'.
  • the container 3' has to be filled with gas before connection of the connector 2' to a receptacle 6'.
  • the volume of the container 3' is preferably variable.
  • the container can comprise a first portion 17' made by a relatively rigid material which first portion is coupled to the connector 2', and a second portion 18' made by a relatively flexible material attached to the first portion 17'.
  • the second portion 18' can be extensible by manipulation of for example a handle 20' arranged at the end of the container 3'.
  • the volume of the container 3' can be increased and decreased, respectively.
  • the container 3' can be designed to have a flexible portion, such as a bellow which is compressible and extendable by affecting the container manually.
  • the container 3' is preferably provided with said handle 20' for regulating the volume of the container 3'.
  • the volume of the container is preferably variable as illustrated, there may be other ways to fill the container while at the same time ensuring the gas passes a filter 21'.
  • the gas container could be constituted by a sealed vacuum-packed flexible bag whose seal can be broken to allow gas to flow into the bag.
  • the gas container is rigid or semi-rigid and pressurized gas is used to fill the container.
  • the amount of gas, preferably air, provided by the pre-filled container should be adapted to the volume of the receptacle which is to be drained off.
  • the volume of the gas when being in the receptacle should preferably correspond to the volume of the receptacle so as to enable the receptacle to be completely drained off. This implies that the volume of the cleaned or sterilized gas in the pre-filled container is preferably approximately equal to or larger than the volume of the receptacle provided that the pressure of the gas is substantially the same in the receptacle as in the container.
  • the volume of the gas should be in the interval 1-100 cm 3 at atmospheric pressure.
  • the integrated unit 4' is provided with the filter 21', such as a particulate air filter for cleaning gas passing the filter 21' during filling the container 3' with gas, preferably by increasing the volume of the container 3', before connection of the connector 2' to a receptacle 6'.
  • the filter hereinafter called particulate air filter 21'
  • the particulate air filter 21' can be arranged in different ways, according to the embodiment illustrated in figure 5 and 6 the particulate air filter 21' is arranged on the connector 2'.
  • the particulate air filter 21' is arranged to be removed from the integrated unit 4' after the container 3' has been filled with cleaned gas. Subsequently to filling the container 3' the particulate air filter 21' is removed and the connector 2' is to be connected to the receptacle 6'.
  • cleaned gas is meant that the gas has been filtered by a filter to remove particles and/or viable micro-organisms to such an extent that the gas is classified to be aseptic and accepted by the relevant authority and/or any standards.
  • the degree of purity can be expressed in the largest particles allowed to pass the filter for a given flow rate. In some cases no or very few particles having a size exceeding 5 ⁇ m are allowed to be present in the cleaned gas. However, the allowed particle size is determined by the requirements in the current application. Some drug treatments require that substantially all particles having a size exceeding 0.15 ⁇ m are removed from the gas by the particulate air filter. As an example, a filter with the mesh size 0.2 ⁇ m can be used to remove substantially all particles and micro organisms of that size or larger.
  • particulate air filter 21' is preferably designed as a needle shield 22' for the tip of needle 14'.
  • the filter can be arranged to at least partially cover or surround the tip of the needle 14'. This implies that the particulate air filter 21' cleans the gas and at the same time the particulate air filter 21' functions as a protection during handling of the device 1'. Furthermore, such a needle tip shield 22' protects the sterile package enclosing the device during transport and storage of the device.
  • any contamination particles removed from the gas and collected in the particulate air filter 21' are removed from the integrated unit 4'.
  • one and the same channel can be used for both filling the container 3' with cleaned gas and transferring the cleaned gas from the container 3' to a receptacle 6'.
  • the particulate air filter 21' has to be arranged so as to avoid contamination during transportation of the gas from the container 3' to the receptacle 6'.
  • the integrated unit 4' can be provided with a first channel 23' for filling the container 3' with cleaned gas and a second channel 15' for transferring the cleaned gas to a receptacle. Otherwise, i.e.
  • the particulate air filter if the particulate air filter is to be left, and one and the same channel is used for transportation of gas in both directions; the particles collected in the particulate air filter could possibly release from the particulate air filter and be unintentionally brought into the receptacle 6' by the gas flow.
  • Such a contamination can be prevented by providing a removable air filter or by providing different openings/channels for transportation of gas into and out of the container 3', respectively.
  • a lid 26' can be arranged on the integrated unit 4' for covering the particulate air filter 21' so as to prevent further communication between the interior of the integrated unit 4' and the environment via the particulate air filter 21' after filling the container 3'. Firstly, the container 3' is filled with the cleaned gas and thereafter the lid 26' is mounted on the integrated unit 4' to cover the particulate air filter 21' and prevent further gas transportation through the air particle filter 21'. Thereafter, the integrated unit 4' and the receptacle 6' are to be interconnected and the subsequent manipulations can be safely executed.
  • the lid 26' has the function of preventing transportation of liquid, gas or any vapour in the direction from the integrated unit 4' to the environment so as to counteract that any undesired substance in the receptacle 6' escapes to the environment.

Landscapes

  • 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)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Claims (8)

  1. Vorrichtung (1') zur Abgabe einer gereinigten Flüssigkeit an einen Behälter (6') und damit zur Erleichterung der Beförderung einer Substanz aus dem Behälter, die umfasst: ein Verbindungselement (2') und ein Gefäß (3'), die eine integrierte Einheit (4') bilden, wobei das Verbindungselement (2') mit einer ersten Einrichtung (5') zur Verbindung mit dem Behälter (6') versehen ist, wobei die integrierte Einheit (4') mit einem Filter (21') zum Reinigen einer das Filter (21') durchlaufenden Flüssigkeit während des Füllens des Gefäßes (3') mit Flüssigkeit durch Vergrößern des Volumens des Gefäßes vor dem Verbinden des Verbindungselements (2') mit dem Behälter (6') versehen ist, dadurch gekennzeichnet, dass die integrierte Einheit (4') mit einem ersten Kanal (23') zum Füllen des Gefäßes (3') mit gereinigter Flüssigkeit und einem zweiten Kanal (15') zum Befördern der gereinigten Flüssigkeit zu dem Behälter (6') versehen ist.
  2. Vorrichtung nach Anspruch 1, dadurch gekennzeichnet, dass die integrierte Einheit (4') eine Nadel (14') zum Durchdringen eines auf dem Behälter (6') angeordneten Verschlusses aufweist.
  3. Vorrichtung nach einem der Ansprüche 1 oder 2, dadurch gekennzeichnet, dass das Volumen des Gefäßes (3') veränderbar ist, so dass das Volumen des Gefäßes beim Füllen des Gefäßes (3') mit Flüssigkeit vergrößert wird.
  4. Vorrichtung nach Anspruch 3, dadurch gekennzeichnet, dass das Gefäß (3') aus einem komprimierbaren Material gefertigt ist, um das Volumen des Gefäßes (3') veränderbar zu gestalten.
  5. Vorrichtung nach einem der Ansprüche 3 oder 4, dadurch gekennzeichnet, dass das Gefäß (3') so konzipiert ist, dass es einen flexiblen Abschnitt wie einen Balg aufweist, der komprimierbar und ausdehnbar ist.
  6. Vorrichtung nach Anspruch 5, dadurch gekennzeichnet, dass der flexible Abschnitt durch manuelles Einwirken auf das Gefäß (3') komprimierbar und ausdehnbar ist.
  7. Vorrichtung nach Anspruch 6, dadurch gekennzeichnet, dass das Gefäß (3') mit einem Handgriff (20') zum Regulieren des Volumens des Gefäßes versehen ist.
  8. Vorrichtung nach einem der Ansprüche 1 - 7, dadurch gekennzeichnet, dass das Verbindungselement (2') mit einer zweiten Einrichtung (12') zum Verbinden eines Übergabeelements (13') zum Befördern einer Substanz aus einem Behälter (6') versehen ist.
EP15198205.5A 2007-06-13 2007-06-13 Vorrichtung zur abgabe von flüssigkeiten an einen behälter Active EP3009121B1 (de)

Priority Applications (3)

Application Number Priority Date Filing Date Title
ES15198205.5T ES2627304T3 (es) 2007-06-13 2007-06-13 Dispositivo para proporcionar fluido a un receptáculo
EP17170133.7A EP3222265B1 (de) 2007-06-13 2007-06-13 Vorrichtung zur abgabe von flüssigkeiten an einen behälter
EP15198205.5A EP3009121B1 (de) 2007-06-13 2007-06-13 Vorrichtung zur abgabe von flüssigkeiten an einen behälter

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
PCT/SE2007/050416 WO2008153460A1 (en) 2007-06-13 2007-06-13 A device for providing fluid to a receptacle
EP07748576.1A EP2155143B1 (de) 2007-06-13 2007-06-13 Vorrichtung zur zuführung von flüssigkeit zu einem behältnis
EP14175968.8A EP2789329B1 (de) 2007-06-13 2007-06-13 Vorrichtung zur zuführung von flüssigkeit zu einem behältnis
EP15198205.5A EP3009121B1 (de) 2007-06-13 2007-06-13 Vorrichtung zur abgabe von flüssigkeiten an einen behälter

Related Parent Applications (3)

Application Number Title Priority Date Filing Date
EP07748576.1A Division EP2155143B1 (de) 2007-06-13 2007-06-13 Vorrichtung zur zuführung von flüssigkeit zu einem behältnis
EP14175968.8A Division-Into EP2789329B1 (de) 2007-06-13 2007-06-13 Vorrichtung zur zuführung von flüssigkeit zu einem behältnis
EP14175968.8A Division EP2789329B1 (de) 2007-06-13 2007-06-13 Vorrichtung zur zuführung von flüssigkeit zu einem behältnis

Related Child Applications (1)

Application Number Title Priority Date Filing Date
EP17170133.7A Division EP3222265B1 (de) 2007-06-13 2007-06-13 Vorrichtung zur abgabe von flüssigkeiten an einen behälter

Publications (2)

Publication Number Publication Date
EP3009121A1 EP3009121A1 (de) 2016-04-20
EP3009121B1 true EP3009121B1 (de) 2017-05-10

Family

ID=40129933

Family Applications (4)

Application Number Title Priority Date Filing Date
EP14175968.8A Active EP2789329B1 (de) 2007-06-13 2007-06-13 Vorrichtung zur zuführung von flüssigkeit zu einem behältnis
EP17170133.7A Active EP3222265B1 (de) 2007-06-13 2007-06-13 Vorrichtung zur abgabe von flüssigkeiten an einen behälter
EP15198205.5A Active EP3009121B1 (de) 2007-06-13 2007-06-13 Vorrichtung zur abgabe von flüssigkeiten an einen behälter
EP07748576.1A Active EP2155143B1 (de) 2007-06-13 2007-06-13 Vorrichtung zur zuführung von flüssigkeit zu einem behältnis

Family Applications Before (2)

Application Number Title Priority Date Filing Date
EP14175968.8A Active EP2789329B1 (de) 2007-06-13 2007-06-13 Vorrichtung zur zuführung von flüssigkeit zu einem behältnis
EP17170133.7A Active EP3222265B1 (de) 2007-06-13 2007-06-13 Vorrichtung zur abgabe von flüssigkeiten an einen behälter

Family Applications After (1)

Application Number Title Priority Date Filing Date
EP07748576.1A Active EP2155143B1 (de) 2007-06-13 2007-06-13 Vorrichtung zur zuführung von flüssigkeit zu einem behältnis

Country Status (5)

Country Link
EP (4) EP2789329B1 (de)
JP (1) JP5091313B2 (de)
CA (2) CA2924477C (de)
ES (4) ES2550675T3 (de)
WO (1) WO2008153460A1 (de)

Families Citing this family (25)

* 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
CA3176437A1 (en) 2011-08-18 2013-02-21 Icu Medical, Inc. Pressure-regulating vial adaptors
US11173244B2 (en) 2011-09-02 2021-11-16 Unl Holdings Llc Drive mechanism for drug delivery pumps with integrated status indication
CN106955394B (zh) 2011-09-02 2020-02-04 尤尼特拉克特注射器控股有限公司 用于具有积体式状态指示的药品输送帮浦的驱动机构
US9707335B2 (en) 2011-09-02 2017-07-18 Unitract Syringe Pty Ltd Drive mechanism for drug delivery pumps with integrated status indication
ES2703108T3 (es) 2011-09-02 2019-03-07 Unl Holdings Llc Mecanismo de inserción para una bomba de administración de fármacos
US9814832B2 (en) 2011-09-02 2017-11-14 Unl Holdings Llc Drive mechanism for drug delivery pumps with integrated status indication
EP3011987B1 (de) 2011-09-13 2020-10-28 UNL Holdings LLC Fluidströmungsverbindung zu arzneimittelbehältern für arzneimittelabgabepumpen
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
JP5510985B2 (ja) 2012-04-02 2014-06-04 株式会社メディカルクリエーション 薬剤移送装置
CA2881305C (en) 2012-08-29 2021-05-04 Unitract Syringe Pty Ltd Variable rate controlled delivery drive mechanisms for drug delivery pumps
ES2966008T3 (es) * 2013-01-23 2024-04-17 Icu Medical Inc Adaptadores de vial de regulación de presión
US9089475B2 (en) 2013-01-23 2015-07-28 Icu Medical, Inc. Pressure-regulating vial adaptors
USD723157S1 (en) 2013-03-12 2015-02-24 Unitract Syringe Pty Ltd Drug delivery pump
WO2014116274A1 (en) * 2013-01-25 2014-07-31 Unitract Syringe Pty Ltd Integrated sliding seal fluid pathway connection and drug containers for drug delivery pumps
CA3179530A1 (en) 2013-07-19 2015-01-22 Icu Medical, Inc. Pressure-regulating fluid transfer systems and methods
EP3157491B1 (de) 2014-06-20 2022-06-22 ICU Medical, Inc. Druckregelungsadapter für eine phiole
AU2015323994A1 (en) 2014-09-29 2017-05-18 Unl Holdings Llc Rigid needle insertion mechanism for a drug delivery pump
CN112245287B (zh) * 2015-03-26 2024-12-10 因内博注射剂公司 加压气体驱动的药剂转移和再悬浮设备和方法
ES2915902T3 (es) 2016-01-29 2022-06-27 Icu Medical Inc Adaptadores de vial para la regulación de presión
KR20190039972A (ko) 2016-08-08 2019-04-16 유엔엘 홀딩스 엘엘씨 약물 전달 장치 및 유체 유로 연결 방법
WO2018064206A1 (en) 2016-09-30 2018-04-05 Icu Medical, Inc. Pressure-regulating vial access devices and methods
US11224555B2 (en) 2018-04-23 2022-01-18 Hospira, Inc. Access and vapor containment system for a drug vial and method of making and using same
US20240099939A1 (en) * 2019-10-31 2024-03-28 Nacatur International Import Export S.R.L. Safety assembly for the reconstitution, the taking and the infusion of pharmacological liquids

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5841966Y2 (ja) * 1979-04-27 1983-09-22 株式会社 ミドリ十字 医療用移注用具
SE434700B (sv) * 1983-05-20 1984-08-13 Bengt Gustavsson Anordning for lufttet overforing av substans fran ett kerl till ett annat
JPH0829793B2 (ja) * 1987-11-07 1996-03-27 大阪エヤゾール工業株式会社 押出し容器
US5017186A (en) 1989-07-11 1991-05-21 Arnold Victor A Device and method for maintaining sterility of multi-dose medicament vials
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
JP2002238979A (ja) * 2001-02-16 2002-08-27 Jms Co Ltd 両頭針
US6715520B2 (en) * 2001-10-11 2004-04-06 Carmel Pharma Ab Method and assembly for fluid transfer
CN101437463B (zh) * 2005-11-07 2012-12-05 伯尔拉工业有限公司 通气的安全处理小瓶配接器
JP5317957B2 (ja) * 2006-04-12 2013-10-16 アイシーユー・メディカル・インコーポレーテッド ビンアダプターおよび圧力を調整するためのビン

Also Published As

Publication number Publication date
JP2010528810A (ja) 2010-08-26
JP5091313B2 (ja) 2012-12-05
EP2789329B1 (de) 2016-08-03
ES2772838T3 (es) 2020-07-08
ES2627304T3 (es) 2017-07-27
CA2924477A1 (en) 2008-12-18
WO2008153460A1 (en) 2008-12-18
ES2600952T3 (es) 2017-02-13
EP2155143B1 (de) 2015-08-19
EP3222265A1 (de) 2017-09-27
EP3222265B1 (de) 2020-01-08
ES2550675T3 (es) 2015-11-11
CA2707342A1 (en) 2008-12-18
EP2155143A4 (de) 2013-08-14
CA2924477C (en) 2019-05-14
EP2155143A1 (de) 2010-02-24
EP2789329A1 (de) 2014-10-15
CA2707342C (en) 2016-06-07
EP3009121A1 (de) 2016-04-20

Similar Documents

Publication Publication Date Title
EP3009121B1 (de) Vorrichtung zur abgabe von flüssigkeiten an einen behälter
US9309020B2 (en) Device for providing fluid to a receptacle
US8622985B2 (en) Arrangement for use with a medical device
US11690788B2 (en) System for closed transfer of fluids
US5533994A (en) Storage and transfer bottle designed for storing two components of a medicamental substance
US20200130873A1 (en) Methods for preparing autologous blood eye drops
CN104394906A (zh) 制造医疗设备的方法
EP2155141B1 (de) Anordnung zur verwendung mit einem medizinprodukt
CN112770710A (zh) 被设计为将容器连接至药瓶的连接装置

Legal Events

Date Code Title Description
PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

AC Divisional application: reference to earlier application

Ref document number: 2789329

Country of ref document: EP

Kind code of ref document: P

Ref document number: 2155143

Country of ref document: EP

Kind code of ref document: P

AK Designated contracting states

Kind code of ref document: A1

Designated state(s): AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HU IE IS IT LI LT LU LV MC MT NL PL PT RO SE SI SK TR

17P Request for examination filed

Effective date: 20160921

RBV Designated contracting states (corrected)

Designated state(s): AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HU IE IS IT LI LT LU LV MC MT NL PL PT RO SE SI SK TR

GRAP Despatch of communication of intention to grant a patent

Free format text: ORIGINAL CODE: EPIDOSNIGR1

RIN1 Information on inventor provided before grant (corrected)

Inventor name: HELMERSON LUNDAHL, ELISABET

Inventor name: BAECKSTROEM, FREDRIK

Inventor name: ELLSTROEM, ANNA

INTG Intention to grant announced

Effective date: 20161206

GRAS Grant fee paid

Free format text: ORIGINAL CODE: EPIDOSNIGR3

GRAA (expected) grant

Free format text: ORIGINAL CODE: 0009210

AC Divisional application: reference to earlier application

Ref document number: 2155143

Country of ref document: EP

Kind code of ref document: P

Ref document number: 2789329

Country of ref document: EP

Kind code of ref document: P

AK Designated contracting states

Kind code of ref document: B1

Designated state(s): AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HU IE IS IT LI LT LU LV MC MT NL PL PT RO SE SI SK TR

REG Reference to a national code

Ref country code: GB

Ref legal event code: FG4D

REG Reference to a national code

Ref country code: AT

Ref legal event code: REF

Ref document number: 891551

Country of ref document: AT

Kind code of ref document: T

Effective date: 20170515

Ref country code: CH

Ref legal event code: EP

REG Reference to a national code

Ref country code: IE

Ref legal event code: FG4D

REG Reference to a national code

Ref country code: FR

Ref legal event code: PLFP

Year of fee payment: 11

REG Reference to a national code

Ref country code: DE

Ref legal event code: R096

Ref document number: 602007050999

Country of ref document: DE

REG Reference to a national code

Ref country code: SE

Ref legal event code: TRGR

REG Reference to a national code

Ref country code: ES

Ref legal event code: FG2A

Ref document number: 2627304

Country of ref document: ES

Kind code of ref document: T3

Effective date: 20170727

REG Reference to a national code

Ref country code: NL

Ref legal event code: MP

Effective date: 20170510

REG Reference to a national code

Ref country code: LT

Ref legal event code: MG4D

REG Reference to a national code

Ref country code: AT

Ref legal event code: MK05

Ref document number: 891551

Country of ref document: AT

Kind code of ref document: T

Effective date: 20170510

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: GR

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20170811

Ref country code: AT

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20170510

Ref country code: LT

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20170510

Ref country code: FI

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20170510

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: NL

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20170510

Ref country code: LV

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20170510

Ref country code: BG

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20170810

Ref country code: IS

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20170910

Ref country code: PL

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20170510

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: RO

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20170510

Ref country code: CZ

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20170510

Ref country code: EE

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20170510

Ref country code: SK

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20170510

Ref country code: DK

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20170510

REG Reference to a national code

Ref country code: CH

Ref legal event code: PL

REG Reference to a national code

Ref country code: DE

Ref legal event code: R097

Ref document number: 602007050999

Country of ref document: DE

PLBE No opposition filed within time limit

Free format text: ORIGINAL CODE: 0009261

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: NO OPPOSITION FILED WITHIN TIME LIMIT

26N No opposition filed

Effective date: 20180213

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: LI

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20170630

Ref country code: CH

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20170630

Ref country code: LU

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20170613

REG Reference to a national code

Ref country code: FR

Ref legal event code: PLFP

Year of fee payment: 12

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: SI

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20170510

REG Reference to a national code

Ref country code: BE

Ref legal event code: MM

Effective date: 20170630

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: BE

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20170630

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: MT

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20170613

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: MC

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20170510

Ref country code: HU

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT; INVALID AB INITIO

Effective date: 20070613

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: CY

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20170510

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: TR

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20170510

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: PT

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20170510

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: DE

Payment date: 20230523

Year of fee payment: 17

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: IE

Payment date: 20240523

Year of fee payment: 18

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: GB

Payment date: 20240521

Year of fee payment: 18

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: IT

Payment date: 20240522

Year of fee payment: 18

Ref country code: FR

Payment date: 20240522

Year of fee payment: 18

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: SE

Payment date: 20240521

Year of fee payment: 18

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: ES

Payment date: 20240701

Year of fee payment: 18