AU2016285216A1 - Needleless injection device equipped with an improved sealing membrane - Google Patents

Needleless injection device equipped with an improved sealing membrane Download PDF

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Publication number
AU2016285216A1
AU2016285216A1 AU2016285216A AU2016285216A AU2016285216A1 AU 2016285216 A1 AU2016285216 A1 AU 2016285216A1 AU 2016285216 A AU2016285216 A AU 2016285216A AU 2016285216 A AU2016285216 A AU 2016285216A AU 2016285216 A1 AU2016285216 A1 AU 2016285216A1
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AU
Australia
Prior art keywords
reservoir
diaphragm
injection device
housing
axially
Prior art date
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Granted
Application number
AU2016285216A
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AU2016285216B2 (en
Inventor
Mabile FRÉDÉRIC
Robin STEINBERGER
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Crossject Co
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Crossject Co
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Publication date
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Publication of AU2016285216A1 publication Critical patent/AU2016285216A1/en
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Publication of AU2016285216B2 publication Critical patent/AU2016285216B2/en
Active legal-status Critical Current
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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2046Media being expelled from injector by gas generation, e.g. explosive charge
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2053Media being expelled from injector by pressurised fluid or vacuum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/30Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

The invention relates to a needleless injection device (10) having a body (12) forming a receptacle (44) which is delimited by a tubular wall (46) and which extends axially from an upper radial seat (48), a gas generator (16), a tubular reservoir (24) which encloses an active principle (26) and which extends axially in said receptacle (44) from an upper end forming an upper flange (40) to a lower end (36), an elastically deformable membrane (50) in the general shape of a T, which comprises a radial annular disc (52) that is interposed axially between the upper flange (40) of the reservoir (24) and said seat (48), and a tubular part (54) which extends axially in the reservoir (24), characterized in that it has an annular washer (64) which is interposed axially between the annular disc (52) of the membrane (50) and the upper flange (40) of the reservoir (24).

Description

Needless injection device equipped with a diaphragm having an improved sealing
The invention concerns a needless injection device including a flexible diaphragm with improved sealing.
The technical field of the invention is the one of disposable pre-filled needleless injection devices, operating with an energy source such as a gas generator, and used for intradermal, subcutaneous and intramuscular injections, of a liquid active ingredient for a therapeutic use in human or veterinary medicine.
The active ingredient is constituted of a more or less viscous liquid, a mixture of liquid, or a gel. The active ingredient may also be a solid dissolved in a solvent suitable for the injection or may be constituted of a pulverulent solid suspended at a certain concentration in a suitable liquid. The grain size distribution of the active ingredient must then be compatible with the diameter of the ducts in order to avoid obstructing them.
An injection device includes, in a known manner, for example as in the patent application FR-A-2815544 (equivalent to WO 02/34317), a body comprising successively a gas generator, an expansion chamber, a reservoir containing the liquid active ingredient and an injection system.
The reservoir is constituted by a glass tube which is inserted into a tubular housing delimited by the body of the device, and which is obstructed by an upstream plunger and a downstream plunger between which the liquid active ingredient is contained.
The downstream or lower free end of the reservoir cooperates with an injection nozzle which delimits at least one injection channel extending axially along an injection axis.
The injection nozzle is axially delimited by an upper face bearing axially on the reservoir, and a lower injection face adapted to cooperate with a closure cap.
In addition, the injection device includes a hollow cover which envelops the body and which delimits a lower opening adapted for the passage of the injection nozzle.
In order to enable the injection of the active ingredient, the body is slidably mounted in the cover, from bottom to top along a sliding axis, between a rest position and an injection position, the driving of the body being carried out when the user presses the injection nozzle on his skin.
The displacement of the body in the cover allows the gas generator to be triggered, generating a pressurized gas which drives in displacement the plungers in order to inject the active ingredient through the patient's skin via the injection nozzle.
There is known an injection device which is equipped with a generally T-shaped elastically deformable diaphragm which comprises a radial annular disc which is axially interposed between the upper end of the reservoir and a seat formed by the body, and a tubular portion which extends axially in the reservoir, from the annular disc.
The tubular portion of the diaphragm is designed to extend axially under the effect of the pressurized gas, in order to drive the plungers in displacement.
In order to ensure the sealing between the reservoir and the body of the device, in particular at the time of injection, the annular disc of the diaphragm is compressed axially between the upper end of the reservoir and the seat formed by the body of the device.
To this end, the injection nozzle is screwed onto the body, at the free end of the housing enclosing the reservoir, in order to axially urge the reservoir against the associated seat.
Surprisingly, it is observed that the annular disc of the diaphragm, once compressed, can flow axially and overflow between the reservoir and the tubular wall of the housing.
Such deformation of the disc may impair the sealing between the diaphragm and the body of the device, thereby causing leakage.
The present invention aims in particular at overcoming this drawback and relates for this purpose to a needleless injection device including: - a body forming a housing which is delimited by a tubular wall and which extends axially from an upper radial seat, - a gas generator, - a tubular reservoir which encloses an active ingredient and which extends axially in said housing from an upper end forming an upper collar, to a lower end, - a generally T-shaped elastically deformable diaphragm, which comprises a radial annular disc which is axially interposed between the upper collar of the reservoir and said seat formed by the body, and a tubular portion which extends axially in the reservoir, from the annular disc, and - an injection nozzle of the active ingredient which is arranged at the lower end of the reservoir, characterized in that it includes an annular washer which is axially interposed between the annular disc of the diaphragm and the upper collar of the reservoir, and which extends generally radially to the tubular wall of the housing of the body, in order to limit the axial creep of the disc of the diaphragm between the reservoir and the tubular wall of said housing, when the disc of the diaphragm is compressed axially.
Thus, the washer allows to limit the space through which the diaphragm can spread or flow, which space is inherent in the geometric manufacturing tolerances of the reservoir and of the body.
Preferably, the annular washer is radially delimited by a peripheral edge which has a radial clearance with the tubular wall of the associated housing, the radial clearance being comprised between 0.075 and 0.025 millimeter depending on the radius of the washer.
According to an embodiment, the disc of the diaphragm forms an annular bead which protrudes axially upwards and which is housed in a groove of complementary shape which is delimited by the seat of the body.
This characteristic allows to improve the sealing between the diaphragm and the body.
Advantageously, in order to promote the sealing between the diaphragm and the body, the disc of the diaphragm is adapted to be arranged without clearance in the space delimited between the seat formed by the body, the upper collar of the reservoir and the tubular wall of the housing formed by the body.
According to another characteristic, the body is made by injection molding.
Moreover, the diaphragm is made of an elastically deformable elastomer-based material.
Also, the injection nozzle is screwed onto an opening free end of the housing formed by the body, the nozzle compressing axially the assembly formed by the reservoir, the diaphragm and the washer on the seat of the housing.
According to a preferred embodiment, the nozzle is screwed according to a tightening torque of at least 120 Newtons.
Also, the active ingredient contained in the reservoir is selected from the group comprising the following active ingredients: - Methotrexate, - Adrenaline, - Sumatriptan, - Hydrocortisone, - Naloxone, - Midazolam, - Apomorphine, - Ethylnatrexone bromide, - Phytomenadione, - Chlorpromazine hydrochloride, - Zuclopenthixol acetate, - Danaparoid sodium, - Enoxaparin sodium, - Estradiol cypionate, - Medoxyprogesterone acetate, - Medroparin calcium, - Methylprednisolone acetate - Heparin calcium, - Terbuline.
Other characteristics and advantages of the invention will become apparent upon reading the following detailed description for the understanding of which reference will be made to the accompanying drawings in which:
Figure 1 is a schematic cross-sectional overview, which illustrates the injection device according to the invention;
Figure 2 is a detail cross-sectional view of Figure 1, which illustrates the diaphragm and the washer in an axially compressed state;
Figure 3 is a detail cross-sectional view of Figure 1, which illustrates the diaphragm and the washer in a rest state before compression;
Figure 4 is a detail cross-sectional view, which illustrates a diaphragm of a needleless injection device according to the prior art.
In the description and claims, in order to clarify the description and claims, the longitudinal, vertical and transverse terminology will be adopted without limitation with reference to the trihedron L, V, T indicated in the figures.
In addition, in the present application, the terms "upper", "lower", "horizontal", "vertical" and their derivatives refer to the position or orientation of an element or a component, this position or orientation being considered with reference to the orientation of the device in the figures and to the trihedron L, V, T without reference to the earth's gravity.
Similarly, the terms "axial" and "radial" should be understood with reference to the injection axis B of the injection device.
Figure 1 shows a needleless injection device 10, or needless syringe, which includes a U-shaped body 12 comprising successively a percussion device 14, a gas generator 16 comprising a primer 18 and a pyrotechnic charge 20, an expansion chamber 22, a reservoir 24 containing the liquid active ingredient 26 and an injection nozzle 28.
The percussion device 14 and the gas generator 16 constitute a first linear subassembly of the body 12 which extends axially along a vertical sliding axis A, and the reservoir 24 containing the active ingredient 26 and the injection nozzle 28 form a second linear subassembly of the body 12 which extends axially along a second vertical injection axis B.
These two sub-assemblies are linked to one another by the expansion chamber 22 which has an axis perpendicular to the axes A, B of the subassemblies.
The reservoir 24 is constituted by a glass tube 30 obstructed by an upstream plunger 32 and a downstream plunger 34 between which the liquid active ingredient 26 is contained, the plungers being made of an elastically deformable elastomer-based material.
The reservoir 24 extends axially from a lower collar 36 which has an annular lower face 38 arranged opposite the injection nozzle 28, to an upper collar 40 having an annular upper face 42.
The reservoir 24 is arranged in a housing 44 formed by the body 12, which housing 44 is radially delimited by a tubular wall 46 which extends about the injection axis B.
The housing 44 extends axially from an upper radial seat 48 which is formed by the body 12 and which delimits an outlet orifice 49 of the expansion chamber 22.
According to a preferred embodiment, the body 12 is made by injection molding of plastic material.
Also, according to Figure 1, the device 10 is equipped with a generally T-shaped elastically deformable diaphragm 50, which comprises a radial annular disc 52 which is axially interposed between the upper collar 40 of the reservoir 24 and the seat 48 formed by the body 12, and a tubular portion 54 which extends axially in the reservoir 24 from the annular disc 52.
The tubular portion 54 of the diaphragm 50 is designed to extend axially under the effect of the pressure of the gas generated by the gas generator 16 in order to push the upstream plunger 32.
Referring to Figure 1, the body 12 is enveloped by a hollow cover 56 which delimits a lower opening closed by a horizontal base 58 forming a cover bottom.
The base 58 delimits a circular passage 60 about the injection axis B which is adapted for the passage of the injection nozzle 28 and the downstream end of the body 12, so that the nozzle 28 includes a lower section protruding vertically downwards out of the cover 56.
More particularly, the nozzle 28 is screwed onto an opening free end of the housing 44 formed by the body 12, the nozzle 28 compressing axially the assembly formed by the reservoir 24 and the diaphragm 50 on the seat 48 of the housing 44.
Also, the injection device 10 is equipped with a stopper 62 which is removably mounted on the body 12 by a bayonet-type locking means.
In accordance with the invention, the device 10 includes an annular antiextrusion washer 64, illustrated in Figures 2 and 3, which extends about the tubular portion 54 of the diaphragm 50 and which is axially interposed between the annular disc 52 of the diaphragm 50 and the upper collar 40 of the reservoir 24.
The anti-extrusion washer 64 is delimited axially by an upper face 66 bearing on the disc 52 of the diaphragm 50 and a lower face 68 bearing on the upper collar 40 of the reservoir 24.
The washer 64 extends generally radially to the tubular wall 46 of the housing 44 of the body 12, in order to limit the axial creep of the disc 52 of the diaphragm 50 between the upper collar 40 of the reservoir 24 and the tubular wall 46 of the housing 44, by deformation, when the disc 52 of the diaphragm 50 is compressed axially.
For this purpose, the annular washer 64 is radially delimited by a peripheral edge 70 which has a radial clearance J, illustrated in Figure 2, with the tubular wall 46 of the associated housing 44.
Preferably, the radial clearance J is comprised between 0.075 and 0.025 millimeter, depending on the radius of the washer 64.
Also, according to a preferred embodiment, the washer 64 has an axial thickness of 0.6 millimeter.
As shown in Figure 2, the disc 52 of the diaphragm 50 forms an annular bead 72 which protrudes axially upwards and which is housed in an annular groove 74 which is delimited by the seat 48 of the body 12.
The annular groove 74 has a shape complementary to that of the disc 52 of the diaphragm 50.
Indeed, the disc 52 of the diaphragm 50 is adapted to be arranged without clearance or tightened in the space delimited between the seat 48 formed by the body 12, the upper collar 40 of the reservoir 24 and the tubular wall 46 of the housing 44 formed by the body 12, as shown in Figure 2, when the injection nozzle 28 is screwed onto the body 12 according to a nominal torque.
The nominal tightening torque of the nozzle 28 is preferably of at least 120 Newtons.
By way of indication, Figure 3 shows the diaphragm 50 in a rest state before the tightening of the nozzle 28, in which the diaphragm 50 is not compressed, the disc 52 of the diaphragm 50 then being free and arranged with a radial clearance with the wall 46 of the housing 44 and with an axial clearance with the seat 48 of the body 12.
As shown in Figure 2, the reduced radial clearance between the antiextrusion washer 64 and the wall 46 of the housing 44 prevents the expansion of the disc 52 of the diaphragm 50.
Conversely, referring to Figure 4, which illustrates the prior art, without an anti-extrusion washer 64, the disc 52 of the diaphragm 50 tends to flow and to spread axially in the clearance delimited between the wall 46 and the reservoir 24.
Indeed, a radial functional clearance is required between the reservoir 24 and the wall 46 of the housing 44 in order to promote the mounting of the reservoir 24 in its housing 44.
This functional clearance is the consequence of tolerances in making the hot-formed glass reservoir 24 and the injected body 12. This functional clearance may vary from 0.15 to 0.55 millimeter, for example.
It is observed that this creep of the diaphragm 50 limits the compression of the disc 52 of the diaphragm 50, the disc 52 being at risk of becoming deformed, in particular during the gas discharge by the gas generator 16 which generates an injection pressure generally equal to 250 bars, and of creating leakage between the diaphragm 50 and the body 12.

Claims (9)

1. A needless injection device (10) including: - a body (12) forming a housing (44) which is delimited by a tubular wall (46) and which extends axially from an upper radial seat (48), - a gas generator (16), - a tubular reservoir (24) which encloses an active ingredient (26) and which extends axially in said housing (44) from an upper end forming an upper collar (40), to a lower end (36), - a generally T-shaped elastically deformable diaphragm (50), which comprises a radial annular disc (52) which is axially interposed between the upper collar (40) of the reservoir (24) and said seat (48) formed by the body (12), and a tubular portion (54) which extends axially in the reservoir (24), from the annular disc (52), and - an injection nozzle (38) of the active ingredient (26) which is arranged at the lower end of the reservoir (24), characterized in that it includes an annular washer (64) which is axially interposed between the annular disc (52) of the diaphragm (50) and the upper collar (40) of the reservoir (24), and which extends generally radially to the tubular wall (46) of the housing (24) of the body (12), in order to limit the creep axial of the disc (52) of the diaphragm (50) between the reservoir (24) and the tubular wall (46) of said housing (44), when the disc (52) of the diaphragm (50) is compressed axially.
2. The needless injection device (10) according to claim 1, characterized in that the annular washer (64) is radially delimited by a peripheral edge (70) which has a radial clearance (J) with the tubular wall (46) of the associated housing (44), the radial clearance being comprised between 0.075 and 0.025 millimeter depending on the radius of the washer (64).
3. The needless injection device (10) according to anyone of the preceding claims, characterized in that the disc (52) of the diaphragm (50) forms an annular bead (74) which protrudes axially upwards and which is housed in a groove (74) of complementary shape which is delimited by the seat (48) of the body (12).
4. The needless injection device (10) according to any one of the preceding claims, characterized in that the disc (52) of the diaphragm (50) is adapted to be arranged without clearance in the space delimited between the seat (48) formed by the body (12), the upper collar (40) of the reservoir (24) and the tubular wall (46) of the housing (44) formed by the body (12).
5. The needless injection device (10) according to any one of the preceding claims, characterized in that the body (12) is made by injection molding.
6. The needless injection device (10) according to any one of the preceding claims, characterized in that the diaphragm (50) is made of an elastically deformable elastomer-based material.
7. The needless injection device (10) according to anyone of the preceding claims, characterized in that the injection nozzle (28) is screwed onto an opening free end of the housing (44) formed by the body (12), the nozzle (28) compressing axially the assembly formed by the reservoir (24), the diaphragm (50) and the washer (64) on the seat (48) of the housing (44).
8. The needless injection device (10) according to claim 7, characterized in that the nozzle (28) is screwed according to a tightening torque of at least 120 Newtons.
9. The needless injection device (10) according to any one of the preceding claims, characterized in that the active ingredient (26) contained in the reservoir (24) is selected from the group comprising the following active ingredients: - Methotrexate, - Adrenaline, - Sumatriptan, - Hydrocortisone, - Naloxone, - Midazolam, - Apomorphine, - Ethylnatrexone bromide, - Phytomenadione, - Chlorpromazine hydrochloride, - Zuclopenthixol acetate, - Danaparoid sodium, - Enoxaparin sodium, - Estradiol cypionate, - Medoxyprogesterone acetate, - Medroparin calcium, - Methylprednisolone acetate - Heparin calcium, - Terbuline.
AU2016285216A 2015-06-30 2016-06-30 Needleless injection device equipped with an improved sealing membrane Active AU2016285216B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
FR15/56163 2015-06-30
FR1556163A FR3038231B1 (en) 2015-06-30 2015-06-30 NEEDLE-FREE INJECTION DEVICE EQUIPPED WITH IMPROVED SEALING MEMBRANE
PCT/FR2016/051657 WO2017001796A1 (en) 2015-06-30 2016-06-30 Needleless injection device equipped with an improved sealing membrane

Publications (2)

Publication Number Publication Date
AU2016285216A1 true AU2016285216A1 (en) 2017-12-07
AU2016285216B2 AU2016285216B2 (en) 2020-04-30

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Family Applications (1)

Application Number Title Priority Date Filing Date
AU2016285216A Active AU2016285216B2 (en) 2015-06-30 2016-06-30 Needleless injection device equipped with an improved sealing membrane

Country Status (13)

Country Link
EP (1) EP3316935B1 (en)
CN (1) CN107787235B (en)
AU (1) AU2016285216B2 (en)
BR (1) BR112017023044B1 (en)
CA (1) CA2984718C (en)
DK (1) DK3316935T3 (en)
ES (1) ES2735140T3 (en)
FR (1) FR3038231B1 (en)
IL (1) IL255216B (en)
MX (1) MX2017014784A (en)
PL (1) PL3316935T3 (en)
RU (1) RU2718703C2 (en)
WO (1) WO2017001796A1 (en)

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5891086A (en) * 1993-07-31 1999-04-06 Weston Medical Limited Needle-less injector
FR2718357B1 (en) * 1994-04-06 1997-10-03 Defarges Alain Moreau Improvements made to a needleless jet injection device.
ZA9610374B (en) * 1995-12-11 1997-06-23 Elan Med Tech Cartridge-based drug delivery device
FR2815544B1 (en) * 2000-10-23 2003-02-14 Poudres & Explosifs Ste Nale SAFETY NEEDLE SYRINGE WITH COMPACT ARCHITECTURE
US20040162517A1 (en) * 2002-12-04 2004-08-19 Otto Furst Needleless hydpodermic injection device with non-electric ignition means
FR2852516B1 (en) * 2003-03-21 2005-11-11 Crossject INJECTION DEVICE WITHOUT NEEDLE WITH MEANS FOR REGULATING THE LEVEL OF PRESSURE OF GASES IN THE COMBUSTION CHAMBER
FR2875413B1 (en) * 2004-09-21 2008-01-11 Snpe Materiaux Energetiques Sa INJECTION DEVICE WITHOUT NEEDLE OPERATING WITH TWO CONCENTRIC ENERGETIC MATERIALS
DE102005054600A1 (en) * 2005-11-14 2007-05-24 Lts Lohmann Therapie-Systeme Ag Cylinder-piston unit with a non-cylindrical chamber
EP1961436B1 (en) * 2007-02-24 2016-08-24 Roche Diabetes Care GmbH Infusion system

Also Published As

Publication number Publication date
DK3316935T3 (en) 2019-07-22
ES2735140T3 (en) 2019-12-16
FR3038231B1 (en) 2017-07-28
IL255216B (en) 2021-07-29
CN107787235B (en) 2020-07-10
RU2018101311A3 (en) 2019-10-23
AU2016285216B2 (en) 2020-04-30
EP3316935B1 (en) 2019-04-24
IL255216A0 (en) 2017-12-31
WO2017001796A1 (en) 2017-01-05
EP3316935A1 (en) 2018-05-09
MX2017014784A (en) 2018-02-15
CN107787235A (en) 2018-03-09
BR112017023044B1 (en) 2022-11-01
FR3038231A1 (en) 2017-01-06
CA2984718A1 (en) 2017-01-05
CA2984718C (en) 2023-07-18
BR112017023044A2 (en) 2018-07-03
RU2018101311A (en) 2019-07-30
RU2718703C2 (en) 2020-04-14
PL3316935T3 (en) 2019-10-31

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