EP3454818B1 - Adapter - Google Patents

Adapter Download PDF

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Publication number
EP3454818B1
EP3454818B1 EP17721142.2A EP17721142A EP3454818B1 EP 3454818 B1 EP3454818 B1 EP 3454818B1 EP 17721142 A EP17721142 A EP 17721142A EP 3454818 B1 EP3454818 B1 EP 3454818B1
Authority
EP
European Patent Office
Prior art keywords
insert
adapter
wall
outer body
circumferential wall
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
EP17721142.2A
Other languages
German (de)
English (en)
French (fr)
Other versions
EP3454818A1 (de
Inventor
Peter Henninger
Markus Kehr
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.)
SFM Medical Devices GmbH
Original Assignee
SFM Medical Devices GmbH
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 SFM Medical Devices GmbH filed Critical SFM Medical Devices GmbH
Publication of EP3454818A1 publication Critical patent/EP3454818A1/de
Application granted granted Critical
Publication of EP3454818B1 publication Critical patent/EP3454818B1/de
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—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
    • 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
    • A61J1/2079—Filtering means
    • A61J1/2086—Filtering means for fluid filtration
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/32—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents for packaging two or more different materials which must be maintained separate prior to use in admixture
    • B65D81/3205—Separate rigid or semi-rigid containers joined to each other at their external surfaces
    • B65D81/3211—Separate rigid or semi-rigid containers joined to each other at their external surfaces coaxially and provided with means facilitating admixture

Definitions

  • the invention relates to an adapter for transferring a substance from a first container to a second container, such as a syringe body, comprising a circumferential wall suitable for receiving the first container, along which and coaxially surrounded by this at least in sections, a cannula body runs, as well as one with the Hollow cylindrical section connected to the cannula body, which can be connected to the second container, the cannula body extending with its longitudinal axis perpendicular to one side of a wall running transversely to the peripheral wall and the hollow cylindrical section extending with its longitudinal axis perpendicular to the other side of the wall.
  • the U.S. 6,558,365 A a device for mixing fluids present in containers is shown, which consists of two adapters that are connected to one another in the manner of a screw connection via Luer lock cones. There is also the possibility of connecting the adapter, which has a female Luer lock cone, to a syringe body.
  • a transfer device for removing or transferring a fluid which consists of a first and a transfer device in The longitudinal axis is displaceable second part. In order to enable the parts to be moved relative to one another, one of the parts must enclose the opening area of a container.
  • Subject of WO 2017/140238 A2 is a transfer device with a first and a second adapter part, which are axially displaceable to one another.
  • a first inner adapter part receives a vial which has a closure and which can be penetrated by a spike extending from the outer, second adapter part.
  • the spike is based on a bottom wall running transversely to the peripheral wall. The spike extends into a hollow cylindrical section protruding from the opposite side of the wall.
  • a closed vial is received by a first adapter part, onto which a second adapter part can be clamped, which has a spike on the one hand and a Luer lock cone on the other hand, which extend from opposite sides of a disk-shaped plate element.
  • a spike on the one hand and a Luer lock cone on the other originate from an outer adapter part ( US 2014/0000738 A1 ).
  • the WO 2011/029184 A1 an adapter with an outer and an inner body can be seen from which on the one hand a cannula and on the other hand a Luer lock cone extend.
  • the inner body has fingers which, on the one hand, receive a plate element protecting the cannula when not in use and, on the other hand, engage behind the neck of a vial after the plate has been deposited.
  • the object of the present invention is to further develop an adapter of the type mentioned at the outset in such a way that it is easy to handle, offers sufficient stability and, in particular, prevents the adapter from being grasped externally the receptacle received by this - also called the vial - is unintentionally changed in position. If necessary, it should also be possible to adapt to containers of different sizes with simple measures.
  • the adapter according to claim 1 has a pot-shaped outer body with an outer peripheral wall and the wall that runs transversely to the longitudinal axis of the outer body, that the pot-shaped outer body has an insert with the peripheral wall that receives the container comprises, and that the outer body and the insert are one unit and immovable to one another in the longitudinal axis direction of the adapter.
  • Cup-shaped means that the outer body basically has a hollow cylinder geometry on the circumferential side, even if the outer body can also have a geometry that deviates from this on the outside.
  • the term cup-shaped outer body also includes one whose outer geometry z. B. that of a polygonal column such as a parallelepiped shape.
  • cup-shaped is to be understood as a synonym.
  • a cup-shaped outer body should, however, in particular convey that the outer body has a cylindrical geometry on the inside.
  • the outer body should also be free of slots on the circumferential side, ie, in deviation from the prior art, there are no slots running in the longitudinal axis direction of the adapter starting from the front edge in order to achieve flexibility.
  • the outer body can be described as closed on the circumference.
  • a separate receptacle forming an insert is provided for the container (vial), which is located within the pot-shaped or hollow-body-shaped outer body, which can be referred to as a housing, so that it can consist of a relatively rigid material, in particular plastic material that retains its geometry when capturing the outer body.
  • the adapter has sections separated by slots on the circumference in order to receive a vial, so that the adapter parts are flexible on the circumference.
  • the outer body and insert form a unit.
  • the outer body and insert cannot be moved in the longitudinal direction with respect to one another.
  • the outer body and the insert are connected to one another, in particular in a materially bonded manner.
  • the unit thus formed is pushed onto a vial or the vial is introduced into the unit. There is no relative displacement in the direction of the longitudinal axis between the outer body and the insert.
  • the insert which is connected to the outer body and forms a unit therewith, is provided for receiving the vial results in a modular one Structure with the result that without changing the geometry of the outer part, i.e. the cup-shaped outer body, inserts of different cross-sections can be introduced in order to be adapted to vials of different dimensions, so that they can be fixed to the required extent.
  • the outer body and the insert are of course connected to one another, in particular in a materially bonded manner, even if, for example, a latching connection or other connection is also possible.
  • the pot-shaped or hollow body-shaped outer body of the adapter forms a housing which, at least in sections, can have a cylindrical geometry on the outside.
  • a filter element can be positioned and fixed without problems.
  • This can previously be connected, such as welded, to the outer surface of the bottom wall of the insert in order to then materially connect the insert to the wall of the pot-shaped or hollow body-shaped outer body, in particular by means of ultrasonic welding, in such a way that the bottom wall is connected to the wall in a liquid-tight manner.
  • This ensures that when the adapter is connected to the second container, in particular the syringe body, the liquid flowing through the hollow cylindrical section, in particular designed as a Luer cone, can flow exclusively via the filter from a vial into the second container.
  • a filter If a filter is available, it should be designed as a surface filter.
  • the filter fabric is placed between two surfaces.
  • the entire surface along which the filter fabric extends can be provided with regular, centrally extending depressions.
  • the supply and discharge of the liquid is preferably carried out via four symmetrically arranged, centrally running channels which lead the liquid to a central depression.
  • the projections in the surface serve as a support for the fabric and thus as a support surface.
  • the female Luer cone makes it easy to remove the prepared medication without the need for a metal cannula. This enables needle-free removal.
  • the circumferential wall of the insert which is surrounded in particular concentrically by the outer circumferential wall of the outer body such as the housing, has projections extending radially into the interior of the insert for holding the container, the circumferential wall being at least in the area of the projections at a distance from Inside of the outer peripheral wall runs.
  • the peripheral wall is preferably completely covered by the outer peripheral wall, but at least in the area of the projections.
  • the projections serve in particular to grip behind a bead-like edge of the vial. So that the elastically bendable projections, which extend from wall sections of the peripheral wall, can be adjusted to the required extent, the peripheral wall is spaced apart from the outer peripheral wall at least in the area of the projections. In particular, it is provided that the circumferential wall extends at a distance from the outer circumferential wall overall.
  • the z. B. formed as a Luer cone hollow cylindrical section from the wall of the housing.
  • the hollow needle body which is preferably designed as a plastic spike and can also be referred to as a cannula body, extends in the opposite direction to the hollow cylindrical section from the bottom wall into the interior of the insert accommodated by the housing.
  • the cannula body or spike extends from the bottom wall of the insert, it is possible to place a filter between the insert and the housing without problems.
  • the outside bottom surface of the insert, along which the filter extends, should be structured so that the filter element does not come into contact with one another.
  • the insert comprises a cylindrical first section running at the bottom and a second section with a larger outer diameter that extends over a step and forms the peripheral wall.
  • the insert is circumferentially connected to the hollow-body-shaped outer body in a liquid-tight manner, in particular there is a material connection which can be produced by means of ultrasonic welding.
  • cup-shaped outer body and the insert present in it are designed in particular as injection molded parts.
  • an adapter 14 is shown in principle.
  • the adapter 14 is used to receive a container or bottle, which is also referred to as a vial 10. Furthermore, the adapter 14 is to be connected to a second container, in particular a syringe body 12, in order to withdraw a medical substance from the vial 10 received by the adapter 14.
  • the adapter 14 has a pot-shaped outer body 18, to be referred to as a housing, which consists of an outer circumferential wall 32 having a hollow cylinder geometry and a wall 24 delimiting this at the end.
  • the outer peripheral wall 32 is closed on the periphery and consists in particular of a dimensionally stable plastic.
  • the invention is not abandoned if the outer geometry of the peripheral wall 32 deviates from a cylinder geometry.
  • the inner geometry of the outer body 18 should have a cylindrical shape.
  • the wall 24 which is also referred to below as the end wall, merges via a step 24 into a radially projecting edge 25 which forms a flange and projects from the peripheral wall 32.
  • the edge 25 is flattened on diametrically opposite sides, as can be seen from the drawings. This is a problem-free detection of the housing, that is to say of the outer body 18, is possible. At the same time, there is roll protection.
  • an insert 46 is introduced into the outer body 18, which is in particular materially connected to the end wall 24 and preferably all the way around it.
  • the insert 46 has a circumferential wall 47 which runs coaxially to the outer circumferential wall 32 and which consequently runs concentrically around the longitudinal axis of the outer body 18 and thus of the adapter 14.
  • the longitudinal axis is illustrated by the dot-dash line 27.
  • the insert 46 serves as a receptacle or holder for the vial 10 to be fixed.
  • projections 48, 50, 52 which extend into the interior of the insert 46 and have a hook-shaped geometry, ie in section, protrude from the peripheral wall 47 of the insert 46 May have triangular geometry in order, after the vial 10 has been properly introduced, to grip behind its bead-like edge and thus ensure fixing.
  • the insert 46 i.e. its circumferential wall 47 at least in the area of the projections 48, 50, 52, but preferably over the entire circumference, at a distance from the inside of the outer peripheral wall 32 of the outer body 18. Furthermore, recesses 49, 51, 53 are provided, which between the projections 48, 50, 52 and the extend along the end wall 24 of the bottom wall 54 of the insert 46.
  • the bottom wall 54 runs along the inside of the end wall 24, with a flat filter 56 between the inside of the end wall 24 and the outside of the intermediate wall 54 can be provided. This is in the Fig. 5 drawn.
  • the filter 56 may previously have been fixed on the outside of the bottom wall 54 of the insert 46 before the insert 46 is inserted into the outer body 18 and connected to it.
  • the bottom wall 54 and the end wall 24 run perpendicular to the longitudinal axis 27.
  • the bottom wall 54 has a circumferential web 58 protruding beyond its outside and lying on a circle, which can be inserted into a corresponding recess 60 in the end wall 24 in order to enable centering.
  • Other centering measures are also possible and are covered by the invention.
  • Corresponding centerings also include centering means arranged at points.
  • the insert 46 can likewise have a stepped geometry in the region of the inside of the step 124, which additionally ensures a desired coaxial alignment of the insert 46 with the outer body 18.
  • the bottom wall 54 merges into the peripheral wall 47 via a step 80, so that the insert 46 is basically composed of two cylindrical sections, namely the cross section delimited by the bottom wall 54 and the outer hollow cylindrical section of which the projections 48, 50, 52 protrude radially inward.
  • the insert 46 should be materially connected to the end wall 24, in particular by means of ultrasonic welding, whereby a liquid-tightness between the insert 46 and the end wall 24 is ensured.
  • a plastic spike 64 forming a hollow puncture spike with a tip 66 which, when the vial 10 is inserted into the insert 46, passes through its closure, thus establishing a connection via the female luer lock cone 26 can be made into a syringe body, not shown and connected to the Luer lock cone 26.
  • the hollow puncture spike can also be referred to as a hollow needle body or cannula body or some other description and is preferably made of plastic.
  • the “cannula” component is therefore not necessarily intended to indicate that metal is used as the material.
  • the support surface i.e. the outside of the bottom wall 54 of the insert 46, along which the filter 56 extends, is structured so that the liquid to be withdrawn is distributed and then via the female Luer lock cone 26 to the syringe body, not shown can arrive.
  • the housing that is to say the outer body 18, consists in particular of a polyolefin, in particular polypropylene.
  • the wall thickness of the outer peripheral wall 32 can be in the range between 1.2 mm and 1.6 mm.
  • Fig. 7 the adapter 14 is shown, which is connected to the vial 10 on the one hand and the syringe body 12 via the female Luer lock cone 26 on the other hand.
  • the female Luer lock cone 26 is known to interact with a male Luer lock cone of the syringe body 12.

Landscapes

  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Fluid Mechanics (AREA)
  • Physics & Mathematics (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Details Of Rigid Or Semi-Rigid Containers (AREA)
EP17721142.2A 2016-06-08 2017-05-03 Adapter Active EP3454818B1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102016110569.4A DE102016110569B3 (de) 2016-06-08 2016-06-08 Adapter
PCT/EP2017/060503 WO2017211505A1 (de) 2016-06-08 2017-05-03 Adapter

Publications (2)

Publication Number Publication Date
EP3454818A1 EP3454818A1 (de) 2019-03-20
EP3454818B1 true EP3454818B1 (de) 2020-11-18

Family

ID=58668898

Family Applications (1)

Application Number Title Priority Date Filing Date
EP17721142.2A Active EP3454818B1 (de) 2016-06-08 2017-05-03 Adapter

Country Status (14)

Country Link
US (1) US10888498B2 (pt)
EP (1) EP3454818B1 (pt)
JP (1) JP6957612B2 (pt)
KR (1) KR102360299B1 (pt)
CN (1) CN109562022B (pt)
AU (1) AU2017278373B2 (pt)
BR (1) BR112018075412B1 (pt)
CA (1) CA3026160C (pt)
DE (1) DE102016110569B3 (pt)
EA (1) EA036730B1 (pt)
ES (1) ES2853208T3 (pt)
IL (1) IL263438B (pt)
MX (1) MX2018015195A (pt)
WO (1) WO2017211505A1 (pt)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102021125666A1 (de) 2021-10-04 2023-04-06 Sfm Medical Devices Gmbh Transfervorrichtung

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE202020101900U1 (de) * 2020-04-07 2021-07-13 Neoperl Gmbh Sanitäres Einsetzteil
US20230066548A1 (en) * 2021-08-25 2023-03-02 Scatter, LLC Connectors and methods for contactless transfer of fluid between containers

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WO2011029184A1 (en) * 2009-09-08 2011-03-17 Duoject Medical Systems Inc. Easy-link device for fluid transfer

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EP3107618B1 (en) * 2014-02-20 2020-01-01 Repro-Med Systems, Inc. Connector with filter
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DE102015107312A1 (de) * 2014-12-30 2016-06-30 Sfm Medical Devices Gmbh Misch- und oder Transfervorrichtung

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Publication number Priority date Publication date Assignee Title
WO2011029184A1 (en) * 2009-09-08 2011-03-17 Duoject Medical Systems Inc. Easy-link device for fluid transfer

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102021125666A1 (de) 2021-10-04 2023-04-06 Sfm Medical Devices Gmbh Transfervorrichtung
WO2023057424A1 (de) 2021-10-04 2023-04-13 Sfm Medical Devices Gmbh Transfervorrichtung mit öffnungsabdeckung

Also Published As

Publication number Publication date
JP2019517376A (ja) 2019-06-24
CA3026160A1 (en) 2017-12-14
CA3026160C (en) 2021-04-13
EA036730B1 (ru) 2020-12-14
EP3454818A1 (de) 2019-03-20
DE102016110569B3 (de) 2017-10-26
BR112018075412B1 (pt) 2024-01-30
EA201892799A1 (ru) 2019-05-31
ES2853208T3 (es) 2021-09-15
KR20190016076A (ko) 2019-02-15
US10888498B2 (en) 2021-01-12
AU2017278373B2 (en) 2019-10-10
US20190142696A1 (en) 2019-05-16
IL263438B (en) 2022-04-01
JP6957612B2 (ja) 2021-11-02
KR102360299B1 (ko) 2022-02-10
WO2017211505A1 (de) 2017-12-14
IL263438A (en) 2019-01-31
CN109562022A (zh) 2019-04-02
CN109562022B (zh) 2022-02-11
BR112018075412A2 (pt) 2019-03-19
MX2018015195A (es) 2019-04-22
AU2017278373A1 (en) 2019-01-03

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