JP6637960B2 - フィルタモジュール - Google Patents
フィルタモジュール Download PDFInfo
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- JP6637960B2 JP6637960B2 JP2017506344A JP2017506344A JP6637960B2 JP 6637960 B2 JP6637960 B2 JP 6637960B2 JP 2017506344 A JP2017506344 A JP 2017506344A JP 2017506344 A JP2017506344 A JP 2017506344A JP 6637960 B2 JP6637960 B2 JP 6637960B2
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- 239000012530 fluid Substances 0.000 claims description 76
- 239000012528 membrane Substances 0.000 claims description 58
- 230000001681 protective effect Effects 0.000 claims description 24
- 102000004127 Cytokines Human genes 0.000 claims description 8
- 108090000695 Cytokines Proteins 0.000 claims description 8
- 239000000411 inducer Substances 0.000 claims description 8
- 239000012982 microporous membrane Substances 0.000 claims description 6
- 239000011148 porous material Substances 0.000 claims description 6
- 238000004519 manufacturing process Methods 0.000 claims description 5
- 239000004695 Polyether sulfone Substances 0.000 claims description 3
- 229920006393 polyether sulfone Polymers 0.000 claims description 3
- 229920002301 cellulose acetate Polymers 0.000 claims description 2
- 230000001698 pyrogenic effect Effects 0.000 claims description 2
- 229920002302 Nylon 6,6 Polymers 0.000 claims 1
- 239000008280 blood Substances 0.000 description 25
- 210000004369 blood Anatomy 0.000 description 25
- 238000006073 displacement reaction Methods 0.000 description 19
- 238000002474 experimental method Methods 0.000 description 18
- 238000003466 welding Methods 0.000 description 10
- 238000000502 dialysis Methods 0.000 description 9
- 239000000463 material Substances 0.000 description 8
- -1 polyethylene terephthalate Polymers 0.000 description 8
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 6
- 238000010790 dilution Methods 0.000 description 6
- 239000012895 dilution Substances 0.000 description 6
- 238000001914 filtration Methods 0.000 description 6
- 229920000139 polyethylene terephthalate Polymers 0.000 description 6
- 239000005020 polyethylene terephthalate Substances 0.000 description 6
- 238000007789 sealing Methods 0.000 description 6
- 238000011282 treatment Methods 0.000 description 6
- 239000007788 liquid Substances 0.000 description 5
- 238000000034 method Methods 0.000 description 5
- 239000002504 physiological saline solution Substances 0.000 description 5
- 239000011780 sodium chloride Substances 0.000 description 5
- 239000000385 dialysis solution Substances 0.000 description 4
- 239000004417 polycarbonate Substances 0.000 description 4
- 229920000515 polycarbonate Polymers 0.000 description 4
- 241000894006 Bacteria Species 0.000 description 3
- 230000000052 comparative effect Effects 0.000 description 3
- 229920001577 copolymer Polymers 0.000 description 3
- 238000009826 distribution Methods 0.000 description 3
- 239000002158 endotoxin Substances 0.000 description 3
- 229920000728 polyester Polymers 0.000 description 3
- 229920002635 polyurethane Polymers 0.000 description 3
- 239000004814 polyurethane Substances 0.000 description 3
- 238000000108 ultra-filtration Methods 0.000 description 3
- 241000283690 Bos taurus Species 0.000 description 2
- 239000004698 Polyethylene Substances 0.000 description 2
- 239000004743 Polypropylene Substances 0.000 description 2
- XECAHXYUAAWDEL-UHFFFAOYSA-N acrylonitrile butadiene styrene Chemical compound C=CC=C.C=CC#N.C=CC1=CC=CC=C1 XECAHXYUAAWDEL-UHFFFAOYSA-N 0.000 description 2
- 229920000122 acrylonitrile butadiene styrene Polymers 0.000 description 2
- 239000004676 acrylonitrile butadiene styrene Substances 0.000 description 2
- 239000000853 adhesive Substances 0.000 description 2
- 230000001070 adhesive effect Effects 0.000 description 2
- 230000001186 cumulative effect Effects 0.000 description 2
- 238000001631 haemodialysis Methods 0.000 description 2
- 238000005534 hematocrit Methods 0.000 description 2
- 230000000322 hemodialysis Effects 0.000 description 2
- 230000014759 maintenance of location Effects 0.000 description 2
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- 239000002861 polymer material Substances 0.000 description 2
- 229920000098 polyolefin Polymers 0.000 description 2
- 229920001155 polypropylene Polymers 0.000 description 2
- 125000001453 quaternary ammonium group Chemical group 0.000 description 2
- 239000000758 substrate Substances 0.000 description 2
- 229920001634 Copolyester Polymers 0.000 description 1
- 101100284769 Drosophila melanogaster hemo gene Proteins 0.000 description 1
- BRLQWZUYTZBJKN-UHFFFAOYSA-N Epichlorohydrin Chemical compound ClCC1CO1 BRLQWZUYTZBJKN-UHFFFAOYSA-N 0.000 description 1
- 239000004677 Nylon Substances 0.000 description 1
- 229920002873 Polyethylenimine Polymers 0.000 description 1
- 230000001580 bacterial effect Effects 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
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- 238000007872 degassing Methods 0.000 description 1
- 238000013461 design Methods 0.000 description 1
- 230000003511 endothelial effect Effects 0.000 description 1
- 238000002615 hemofiltration Methods 0.000 description 1
- 230000036039 immunity Effects 0.000 description 1
- 238000010348 incorporation Methods 0.000 description 1
- 230000036512 infertility Effects 0.000 description 1
- 230000004968 inflammatory condition Effects 0.000 description 1
- 230000002757 inflammatory effect Effects 0.000 description 1
- 238000001802 infusion Methods 0.000 description 1
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- 239000002245 particle Substances 0.000 description 1
- 230000002572 peristaltic effect Effects 0.000 description 1
- 239000003330 peritoneal dialysis fluid Substances 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 239000004800 polyvinyl chloride Substances 0.000 description 1
- 238000000746 purification Methods 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
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- 238000009423 ventilation Methods 0.000 description 1
- 230000000007 visual effect Effects 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/34—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
- A61M1/342—Adding solutions to the blood, e.g. substitution solutions
- A61M1/3455—Substitution fluids
- A61M1/3462—Circuits for the preparation thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1654—Dialysates therefor
- A61M1/1656—Apparatus for preparing dialysates
- A61M1/1672—Apparatus for preparing dialysates using membrane filters, e.g. for sterilising the dialysate
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/165—Filtering accessories, e.g. blood filters, filters for infusion liquids
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
- B01D61/24—Dialysis ; Membrane extraction
- B01D61/28—Apparatus therefor
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D63/00—Apparatus in general for separation processes using semi-permeable membranes
- B01D63/08—Flat membrane modules
- B01D63/087—Single membrane modules
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D69/00—Semi-permeable membranes for separation processes or apparatus characterised by their form, structure or properties; Manufacturing processes specially adapted therefor
- B01D69/02—Semi-permeable membranes for separation processes or apparatus characterised by their form, structure or properties; Manufacturing processes specially adapted therefor characterised by their properties
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/165—Filtering accessories, e.g. blood filters, filters for infusion liquids
- A61M2005/1655—Filter with fibers, e.g. filtering element in form of hollow fibers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/165—Filtering accessories, e.g. blood filters, filters for infusion liquids
- A61M2005/1657—Filter with membrane, e.g. membrane, flat sheet type infusion filter
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/75—General characteristics of the apparatus with filters
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2313/00—Details relating to membrane modules or apparatus
- B01D2313/20—Specific housing
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2313/00—Details relating to membrane modules or apparatus
- B01D2313/20—Specific housing
- B01D2313/203—Open housings
- B01D2313/2031—Frame or cage-like structures
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2313/00—Details relating to membrane modules or apparatus
- B01D2313/23—Specific membrane protectors, e.g. sleeves or screens
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2313/00—Details relating to membrane modules or apparatus
- B01D2313/58—Parts of membrane modules specifically adapted for single use
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2325/00—Details relating to properties of membranes
- B01D2325/16—Membrane materials having positively charged functional groups
Landscapes
- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Chemical & Material Sciences (AREA)
- Hematology (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Urology & Nephrology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Vascular Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Water Supply & Treatment (AREA)
- Emergency Medicine (AREA)
- External Artificial Organs (AREA)
- Separation Using Semi-Permeable Membranes (AREA)
- Picture Signal Circuits (AREA)
- Image Processing (AREA)
Description
図6aに示す希釈前モードでの血液透析ろ過構成を実験に用いた。この構成は、血液ポンプ6、透析流体ポンプ7、および置換流体ポンプ8を特徴とする透析装置(AK 200 ULTRA S、Gambro AB)に取り付けられた透析器9(Polyflux(R) P210H、Gambro Dialysatoren GmbH)を含んでいた。図4に示す25cm2の活性膜表面を有するフィルタモジュール5を、置換流体ポンプ8の下流側の置換流体ラインに設けた。
本開示によるフィルタモジュールの代わりに25cm2の活性膜表面を有するEP2314332A1号(図1に示す)に従ったフィルタモジュール5を用いて実施例1を繰り返した。実験中、フィルタモジュール5内の膜の破断が観察された。実験を4回繰り返し、各回において同じ型の異なるフィルタモジュール5を使用した。各場合において、フィルタモジュール5の膜は、実験の実行中に破損した。個々の実行についての破断までの時間は以下の通りである。
図6bに示す希釈後モードでの血液透析ろ過構成を実験に用いた。この構成は、血液ポンプ6、透析流体ポンプ7、および置換流体ポンプ8を特徴とする透析装置(AK 200 ULTRA S、Gambro AB)に取り付けられた透析器9(Polyflux(R) P210H、Gambro Dialysatoren GmbH)を含んでいた。図4に示す25cm2の活性膜表面を有するフィルタモジュール5を、置換流体ポンプ8の下流側の置換流体ラインに設けた。
本開示によるフィルタモジュールの代わりに25cm2の活性膜表面を有するEP2314332A1号(図1に示す)に従ったフィルタモジュール5を用いて実施例2を繰り返した。実験中、フィルタモジュール5内の膜の破断が観察された。実験を4回繰り返し、各回において同じ型の異なるフィルタモジュール5を使用した。各場合において、フィルタモジュール5の膜は、実験の実行中に破損した。個々の実行についての破断までの時間は以下の通りである。
25cm2の活性膜表面を有する図4に示すフィルタモジュール5を、透析装置(AK 200 ULTRA S、Gambro AB)の置換流体ポンプ8に接続した。置換流体ポンプ8とフィルタモジュール5の入口との間に圧力点測定を挿入した。膜間圧(TMP)を、450ml/分の流量で測定された、フィルタ入口とフィルタ出口との間の圧力差(mmHgで表示)として決定した。フィルタモジュール5の上流の圧力点で読み取られた空のTMPを得るために、フィルタの出口ラインを空気に開放した(大気圧)。
本開示によるフィルタモジュールの代わりに25cm2の活性膜表面を有するEP2314332A1号(図1に示す)に従ったフィルタモジュール5を用いて実施例3を繰り返した。TMPを、同一の型の40個のフィルタモジュール5について測定した。結果のボックスプロットを図7に示す。
図6aに示すように、希釈前モードでの血液透析ろ過構成を実験に用いた。この構成は、血液ポンプ6、透析流体ポンプ7、および置換流体ポンプ8を特徴とする透析装置(AK 200 ULTRA S、Gambro AB)に取り付けられた透析器9(Polyflux(R) P140H、Gambro Dialysatoren GmbH)を備えていた。25cm2の活性膜表面を有する図4に示すフィルタモジュール5を、置換流体ポンプ8の下流の置換流体ラインに設けた。
図6bに示すように、希釈後モードでの血液透析ろ過構成を実験に用いた。この構成は、血液ポンプ6、透析流体ポンプ7、および置換流体ポンプ8を特徴とする透析装置(AK 200 ULTRA S、Gambro AB)に取り付けられた透析器9(Polyflux(R) P140H、Gambro Dialysatoren GmbH)を備えていた。25cm2の活性膜表面を有する図4に示すフィルタモジュール5を、置換流体ポンプ8の下流の置換流体ラインに設けた。
Claims (12)
- 滅菌され、非発熱性であり、サイトカイン誘導物質を含まない医療用流体のオンライン生産が可能な使い捨てフィルタモジュールであって、
a) 以下を含むハウジングと、
a1) 複数の長手方向リブ(104)および横方向リブ(105)からなる支持構造(103)を含む流体コンパートメント(102)、ならびに流体コンパートメント(102)の一端で底部部分(1)の中心線上に配置された流体出口(101)を含む底部部分(1)
a2) 複数の長手方向リブ(204)および横方向リブ(205)からなる支持構造(203)を含む流体コンパートメント(202)、ならびに流体コンパートメント(202)の一方の端部壁上で頂部部分(2)の中心線上に配置された流体入口(201)を含む頂部部分(2)
b) ハウジング内に配置され、底部部分(1)の長手方向リブ(104)の上に配置された保護ネット(301)と、
c)ハウジング内に配置され、保護ネット(301)の上に配置された正に帯電した微孔性平膜(302)と、
d)ハウジング内に配置され、正に帯電した微孔性平膜(302)と頂部部分(2)の長手方向リブ(204)との間に位置する保持ネット(303)と
を含む該フィルタモジュール。 - 長手方向リブ(104、204)の高さは、流体コンパートメント(102、202)の深さに等しく、横方向リブ(105、205)の高さは長手方向リブ(104、204)の高さよりも低い請求項1に記載のモジュール。
- 保護ネット(301)は、PETモノフィラメントから織られたネットである請求項1または2に記載のモジュール。
- 保護ネット(301)は、100から600μmの範囲のメッシュ開口を有する請求項1から3のいずれか一項に記載のモジュール。
- 正に帯電した微孔性膜(302)は、ポリエーテルスルホン、ナイロン6,6または酢酸セルロースを含む請求項1から4のいずれか一項に記載のモジュール。
- 正に帯電した微孔性膜(302)は、200から400nmの範囲の細孔サイズを有する請求項1から5のいずれか一項に記載のモジュール。
- 保持ネット(303)はPETから構成される請求項1から6のいずれか一項に記載のモジュール。
- 保持ネット(303)の厚さは、0.9から1.7mmの範囲にある請求項7に記載のモジュール。
- 保持ネット(303)は、それらの周囲で一緒に溶接された3つの個別の層から構成される請求項7または8に記載のモジュール。
- 保持ネット(303)の中間層は、最上層および最下層のメッシュ開口よりも大きなメッシュ開口を有するネットである請求項9に記載のモジュール。
- 保持ネット(303)の中間層は、600から1000μmの範囲のメッシュ開口を有し、最上層および最下層は、400から600μmの範囲のメッシュ開口を有する請求項10に記載のモジュール。
- 追加の保護ネット(301)によって分離された2つの正に帯電した微孔性平膜(302)を含む請求項1から11のいずれか一項に記載のモジュール。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP14179850.4A EP2982398B1 (en) | 2014-08-05 | 2014-08-05 | Filter module |
EP14179850.4 | 2014-08-05 | ||
PCT/EP2015/068004 WO2016020412A1 (en) | 2014-08-05 | 2015-08-05 | Filter module |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2017526422A JP2017526422A (ja) | 2017-09-14 |
JP6637960B2 true JP6637960B2 (ja) | 2020-01-29 |
Family
ID=51265589
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2017506344A Active JP6637960B2 (ja) | 2014-08-05 | 2015-08-05 | フィルタモジュール |
Country Status (8)
Country | Link |
---|---|
US (1) | US10201648B2 (ja) |
EP (1) | EP2982398B1 (ja) |
JP (1) | JP6637960B2 (ja) |
CN (1) | CN105311693B (ja) |
AU (1) | AU2015299007B2 (ja) |
CA (1) | CA2954323C (ja) |
ES (1) | ES2644995T3 (ja) |
WO (1) | WO2016020412A1 (ja) |
Families Citing this family (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
FR3034995A1 (fr) * | 2015-04-20 | 2016-10-21 | Safe | Filtre membranaire a usage unique et kit medical comprenant un tel filtre |
IT201800005165A1 (it) * | 2018-05-08 | 2019-11-08 | Filtro per linee medicali di infusione | |
EP4084886A4 (en) * | 2019-12-31 | 2023-09-06 | Repligen Corporation | FILTRATION CASSETTE IN A BAG AND METHODS OF USING THE SAME |
Family Cites Families (19)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS5555731Y2 (ja) * | 1976-10-12 | 1980-12-24 | ||
US4276170A (en) * | 1978-08-16 | 1981-06-30 | Critikon, Inc. | Vented flexible filtration device for use in administering parenteral liquids |
FR2504392A1 (fr) * | 1981-04-24 | 1982-10-29 | Hospal Sodip | Appareil a membrane avec supports a action decalee |
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US10201648B2 (en) | 2019-02-12 |
CN105311693A (zh) | 2016-02-10 |
WO2016020412A1 (en) | 2016-02-11 |
AU2015299007B2 (en) | 2019-05-02 |
CN105311693B (zh) | 2018-01-12 |
AU2015299007A1 (en) | 2017-02-02 |
EP2982398A1 (en) | 2016-02-10 |
US20170209636A1 (en) | 2017-07-27 |
JP2017526422A (ja) | 2017-09-14 |
ES2644995T3 (es) | 2017-12-01 |
CA2954323C (en) | 2022-10-04 |
CA2954323A1 (en) | 2016-02-11 |
EP2982398B1 (en) | 2017-09-20 |
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