JP6400078B2 - 洗練された駆動機構を含む自動薬物注射デバイス - Google Patents
洗練された駆動機構を含む自動薬物注射デバイス Download PDFInfo
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- JP6400078B2 JP6400078B2 JP2016506884A JP2016506884A JP6400078B2 JP 6400078 B2 JP6400078 B2 JP 6400078B2 JP 2016506884 A JP2016506884 A JP 2016506884A JP 2016506884 A JP2016506884 A JP 2016506884A JP 6400078 B2 JP6400078 B2 JP 6400078B2
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- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
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- A61M5/31545—Setting modes for dosing
- A61M5/31548—Mechanically operated dose setting member
- A61M5/3155—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe
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- A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
- A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
- A61M5/31578—Constructional features or modes of drive mechanisms for piston rods based on axial translation, i.e. components directly operatively associated and axially moved with plunger rod
- A61M5/3158—Constructional features or modes of drive mechanisms for piston rods based on axial translation, i.e. components directly operatively associated and axially moved with plunger rod performed by axially moving actuator operated by user, e.g. an injection button
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- A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
- A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
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- A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
- A61M5/31583—Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod
- A61M5/31585—Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod performed by axially moving actuator, e.g. an injection button
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- A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
- A61M5/3159—Dose expelling manners
- A61M5/31591—Single dose, i.e. individually set dose administered only once from the same medicament reservoir, e.g. including single stroke limiting means
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- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
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- A61M2005/2006—Having specific accessories
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- A—HUMAN NECESSITIES
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- A61M2005/2086—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically having piston damping means, e.g. axially or rotationally acting retarders
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- A61M5/178—Syringes
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- A61M5/3129—Syringe barrels
- A61M2005/314—Flat shaped barrel forms, e.g. credit card shaped
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- 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
- A61M5/178—Syringes
- A61M5/31—Details
- A61M2005/3143—Damping means for syringe components executing relative movements, e.g. retarders or attenuators slowing down or timing syringe mechanisms
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- A—HUMAN NECESSITIES
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- 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
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31501—Means for blocking or restricting the movement of the rod or piston
- A61M2005/31508—Means for blocking or restricting the movement of the rod or piston provided on the piston-rod
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- 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
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
- A61M2005/3152—Piston or piston-rod constructions, e.g. connection of piston with piston-rod including gearings to multiply or attenuate the piston displacing force
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- 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
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31533—Dosing mechanisms, i.e. setting a dose
- A61M5/31535—Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
- A61M5/31536—Blocking means to immobilize a selected dose, e.g. to administer equal doses
- A61M2005/3154—Blocking means to immobilize a selected dose, e.g. to administer equal doses limiting maximum permissible dose
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- A61M2205/00—General characteristics of the apparatus
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- A61M2205/581—Means for facilitating use, e.g. by people with impaired vision by audible feedback
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- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31533—Dosing mechanisms, i.e. setting a dose
- A61M5/31535—Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
- A61M5/31541—Means preventing setting of a dose beyond the amount remaining in the cartridge
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- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31533—Dosing mechanisms, i.e. setting a dose
- A61M5/31545—Setting modes for dosing
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Description
ここで、一実施形態において、薬学的に活性な化合物は、最大1500Daまでの分子量を有し、および/または、ペプチド、タンパク質、多糖類、ワクチン、DNA、RNA、酵素、抗体もしくはそのフラグメント、ホルモンもしくはオリゴヌクレオチド、または上述の薬学的に活性な化合物の混合物であり、
ここで、さらなる実施形態において、薬学的に活性な化合物は、糖尿病、または糖尿病性網膜症などの糖尿病関連の合併症、深部静脈血栓塞栓症または肺血栓塞栓症などの血栓塞栓症、急性冠症候群(ACS)、狭心症、心筋梗塞、がん、黄斑変性症、炎症、枯草熱、アテローム性動脈硬化症および/または関節リウマチの処置および/または予防に有用であり、
ここで、さらなる実施形態において、薬学的に活性な化合物は、糖尿病または糖尿病性網膜症などの糖尿病に関連する合併症の処置および/または予防のための少なくとも1つのペプチドを含み、
ここで、さらなる実施形態において、薬学的に活性な化合物は、少なくとも1つのヒトインスリンもしくはヒトインスリン類似体もしくは誘導体、グルカゴン様ペプチド(GLP−1)もしくはその類似体もしくは誘導体、またはエキセンジン−3もしくはエキセンジン−4もしくはエキセンジン−3もしくはエキセンジン−4の類似体もしくは誘導体を含む。
H−(Lys)4−desPro36,desPro37エキセンジン−4(1−39)−NH2、
H−(Lys)5−desPro36,desPro37エキセンジン−4(1−39)−NH2、
desPro36エキセンジン−4(1−39)、
desPro36[Asp28]エキセンジン−4(1−39)、
desPro36[IsoAsp28]エキセンジン−4(1−39)、
desPro36[Met(O)14,Asp28]エキセンジン−4(1−39)、
desPro36[Met(O)14,IsoAsp28]エキセンジン−(1−39)、
desPro36[Trp(O2)25,Asp28]エキセンジン−4(1−39)
、
desPro36[Trp(O2)25,IsoAsp28]エキセンジン−4(1−39)、
desPro36[Met(O)14,Trp(O2)25,Asp28]エキセンジン−4(1−39)、
desPro36[Met(O)14Trp(O2)25,IsoAsp28]エキセンジン−4(1−39);または
desPro36[Asp28]エキセンジン−4(1−39)、
desPro36[IsoAsp28]エキセンジン−4(1−39)、
desPro36[Met(O)14,Asp28]エキセンジン−4(1−39)、
desPro36[Met(O)14,IsoAsp28]エキセンジン−(1−39)、
desPro36[Trp(O2)25,Asp28]エキセンジン−4(1−39)、
desPro36[Trp(O2)25,IsoAsp28]エキセンジン−4(1−39)、
desPro36[Met(O)14,Trp(O2)25,Asp28]エキセンジン−4(1−39)、
desPro36[Met(O)14,Trp(O2)25,IsoAsp28]エキセンジン−4(1−39)、
(ここで、基−Lys6−NH2が、エキセンジン−4誘導体のC−末端に結合していてもよい);
desPro36エキセンジン−4(1−39)−Lys6−NH2(AVE0010)、
H−(Lys)6−desPro36[Asp28]エキセンジン−4(1−39)−Lys6−NH2、
desAsp28Pro36,Pro37,Pro38エキセンジン−4(1−39)−NH2、
H−(Lys)6−desPro36,Pro38[Asp28]エキセンジン−4(1−39)−NH2、
H−Asn−(Glu)5desPro36,Pro37,Pro38[Asp28]エキセンジン−4(1−39)−NH2、
desPro36,Pro37,Pro38[Asp28]エキセンジン−4(1−39)−(Lys)6−NH2、
H−(Lys)6−desPro36,Pro37,Pro38[Asp28]エキセンジン−4(1−39)−(Lys)6−NH2、
H−Asn−(Glu)5−desPro36,Pro37,Pro38[Asp28]エキセンジン−4(1−39)−(Lys)6−NH2、
H−(Lys)6−desPro36[Trp(O2)25,Asp28]エキセンジン−4(1−39)−Lys6−NH2、
H−desAsp28Pro36,Pro37,Pro38[Trp(O2)25]エキセンジン−4(1−39)−NH2、
H−(Lys)6−desPro36,Pro37,Pro38[Trp(O2)25,Asp28]エキセンジン−4(1−39)−NH2、
H−Asn−(Glu)5−desPro36,Pro37,Pro38[Trp(O2)25,Asp28]エキセンジン−4(1−39)−NH2、
desPro36,Pro37,Pro38[Trp(O2)25,Asp28]エキセンジン−4(1−39)−(Lys)6−NH2、
H−(Lys)6−desPro36,Pro37,Pro38[Trp(O2)25,Asp28]エキセンジン−4(1−39)−(Lys)6−NH2、
H−Asn−(Glu)5−desPro36,Pro37,Pro38[Trp(O2)25,Asp28]エキセンジン−4(1−39)−(Lys)6−NH2、
H−(Lys)6−desPro36[Met(O)14,Asp28]エキセンジン−4(1−39)−Lys6−NH2、
desMet(O)14,Asp28Pro36,Pro37,Pro38エキセンジン−4(1−39)−NH2、
H−(Lys)6−desPro36,Pro37,Pro38[Met(O)14,Asp28]エキセンジン−4(1−39)−NH2、
H−Asn−(Glu)5−desPro36,Pro37,Pro38[Met(O)14,Asp28]エキセンジン−4(1−39)−NH2;
desPro36,Pro37,Pro38[Met(O)14,Asp28]エキセンジン−4(1−39)−(Lys)6−NH2、
H−(Lys)6−desPro36,Pro37,Pro38[Met(O)14,Asp28]エキセンジン−4(1−39)−(Lys)6−NH2、
H−Asn−(Glu)5desPro36,Pro37,Pro38[Met(O)14,Asp28]エキセンジン−4(1−39)−(Lys)6−NH2、
H−Lys6−desPro36[Met(O)14,Trp(O2)25,Asp28]エキセンジン−4(1−39)−Lys6−NH2、
H−desAsp28,Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25]エキセンジン−4(1−39)−NH2、
H−(Lys)6−desPro36,Pro37,Pro38[Met(O)14,Asp28]エキセンジン−4(1−39)−NH2、
H−Asn−(Glu)5−desPro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]エキセンジン−4(1−39)−NH2、
desPro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]エキセンジン−4(1−39)−(Lys)6−NH2、
H−(Lys)6−desPro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]エキセンジン−4(S1−39)−(Lys)6−NH2、
H−Asn−(Glu)5−desPro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]エキセンジン−4(1−39)−(Lys)6−NH2;
または前述のいずれか1つのエキセンジン−4誘導体の薬学的に許容される塩もしくは溶媒和化合物
から選択される。
2 近位方向
3 駆動機構
4 回転軸
5 用量増分方向
6 用量減分方向
10 薬物送達デバイス
12 カートリッジ
14 ピストン
15 ニードルアセンブリ
16 針ハブ
17 針キャップ
20 ハウジング
21 上側ハウジング部分
22 下側ハウジング部分
23 カートリッジ窓
24 キャップ
25 ソケット
26 用量標示窓
27 近位止め具
28 遠位止め具
29 レセプタクル
29a スリット
30 クリック部材
31 クリック部材
32 ラチェット部材
33 軸受
36 クリック部材
37 固定リム
38 案内構造
40 用量投薬ボタン
41 ストラット
41a 近位ストラット部分
41b 遠位ストラット部分
42 案内部材
42a 外側案内部分
43 ピン
44 ストラット
45 ばね要素
46 ピン
50 用量設定部材
51 レセプタクル
52 把持バー
53 冠歯車
54 用量標示ホイール
55 スプロケット
56 用量標示ホイール
57 歯車付きリム
57a 冠歯車
58 歯車
59 歯車付きリム
60 スプロケット
61 リング構造
62 コグ
70 駆動部材
71 歯付きラック部分
72 スリーブ部分
73 バー
74 歯
75 隆起部分
75a レッジ
76 リム
77 突出部
78 ばね要素
79 雌ねじ
80 駆動スピンドル
81 雄ねじ
82 歯付きリム
83 歯
86 ピニオン
88 歯
89 軸受部分
90 駆動スリーブ
92 フランジ部分
93 歯車付きリム
94 冠歯車
95 雌ねじ
100 駆動ホイール
102 歯車付きリム
104 雌ねじ
106 冠歯車
110 皿ばね
120 ピストンロッド
121 ねじ
122 溝
124 止め部材
126 圧力部片
128 冠歯車
130 用量制限部材
132 スリーブ部分
133 雄ねじ
135 突出部
136 歯車付きリム
137 ブラケット部分
138 分岐部
139 分岐部
140 調整部材
141 スリーブ部分
142 スリット
144 付勢部材
146 隆出部分
150 ラチェット部材
151 段差付きの部分
153 掛止要素
154 ラグ
155 切欠き
156 側壁
Claims (16)
- 薬剤の用量を設定および投薬するための薬物送達デバイスの駆動機構であって:
軸方向(1、2)に延びるハウジング(20)と、
遠位軸方向(1)にピストン(14)を変位させるためにカートリッジ(12)のピストン(14)と動作可能に係合するためのピストンロッド(120)と、
用量投薬中にピストンロッド(120)の動作可能に係合可能な駆動スピンドル(80)と、
用量設定中に圧縮ばね要素(78)の作用に反して駆動スピンドル(80)に対して軸方向で変位可能であり、スピンドルギアを形成するために、駆動スピンドル(80)とねじ係合される駆動部材(70)とを含み、
駆動部材(70)は、駆動スピンドル(80)とねじ係合される内面を備えた中空スリーブ部分(72)を含み、
駆動部材(70)は、ハウジング(20)に対して回転できないようロックされ、用量の設定のために、圧縮ばね要素(78)の作用に反して軸方向で近位方向に変位可能であり、駆動スピンドル(80)の用量増分のための回転を誘起し、駆動部材(70)は、用量の投薬のために、圧縮ばね要素(78)の作用下で遠位方向に変位可能であり、駆動スピンドル(80)の用量投薬回転を誘起する前記駆動機構。 - 駆動部材(70)は、軸方向に延びる歯付きラック部分(71)をさらに含む請求項1に記載の駆動機構。
- ハウジング(20)の側壁(22)に回転可能に取り付けられた用量設定部材(50)をさらに含む請求項1または2に記載の駆動機構。
- ラック部分(71)は、用量設定部材(50)と動作可能に係合された歯車(58)のピニオン(60)と係合される請求項2に記載の駆動機構。
- 駆動部材(70)は、ハウジング(20)内で軸方向で摺動可能に配設される請求項1〜4のいずれか1項に記載の駆動機構。
- 駆動部材(70)は、遠位止め具(28)と近位止め具(27)の間でハウジング(20)に対して軸方向で変位可能である請求項1〜5のいずれか1項に記載の駆動機構。
- ばね要素(78)は、駆動スピンドル(80)の周りに延びる圧縮ばねを含む請求項1〜6のいずれか1項に記載の駆動機構。
- ばね要素(78)は、軸方向で、駆動部材(70)と駆動スピンドル(80)の間に延びる請求項1〜7のいずれか1項に記載の駆動機構。
- 駆動スピンドル(80)は、ラチェット部材(150)と回転可能に係合された歯付きリム(82)を含む請求項1〜8のいずれか1項に記載の駆動機構。
- ラチェット部材(150)は、円弧形状の掛止要素(153)を含み、該掛止要素は、駆動スピンドル(80)の歯付きリム(82)と選択的に係合または係合解除するために半径方向で可変に応力付与可能である請求項9に記載の駆動機構。
- 用量設定部材(50)は、第1の用量標示ホイール(54)および第2の用量標示ホイール(56)と回転可能に係合されて、ハウジング(20)の用量標示窓(26)内に数値の少なくとも第1および第2の桁を表示する請求項3〜10のいずれか1項に記載の駆動機構。
- 駆動スピンドル(80)の遠位端に固定され、ハウジング(20)内に回転可能に支持された駆動スリーブ(90)と噛合されるピニオン(86)をさらに含む請求項1〜11のいずれか1項に記載の駆動機構。
- 駆動スリーブ(90)は、遠位止め位置と近位止め位置との間で軸方向で変位可能であり、駆動スリーブ(90)は、遠位止め位置でピストンロッド(120)と回転可能に係合され、駆動スリーブ(90)は、近位止め位置でピストンロッド(120)から係合解除される請求項12に記載の駆動機構。
- 用量設定モードから用量投薬モードに駆動機構を切り替えるために、ラチェット部材(150)および駆動スリーブ(90)と個別に係合するための、ハウジング(20)の近位端に位置する軸方向で変位可能な用量投薬ボタン(40)をさらに含む請求項12または13に記載の駆動機構。
- 請求項1〜14のいずれか1項に記載の駆動機構(3)と、
薬剤を収容し、駆動機構(3)のハウジング(20)内に配置されたカートリッジ(12)と
を含む、薬剤の用量を設定および投薬するための薬物送達デバイス。 - 薬剤の用量を設定および投薬するための薬物送達デバイスの駆動機構であって:
軸方向(1、2)に延びるハウジング(20)と、
遠位軸方向(1)にピストン(14)を変位させるためにカートリッジ(12)のピストン(14)と動作可能に係合するためのピストンロッド(120)と、
用量投薬中にピストンロッド(120)の動作可能に係合可能な駆動スピンドル(80)と、
用量設定中にばね要素(78)の作用に反して駆動スピンドル(80)に対して軸方向で変位可能であり、スピンドルギアを形成するために、駆動スピンドル(80)とねじ係合される駆動部材(70)とを含み、
ばね要素(78)が、軸方向で、駆動部材(70)と駆動スピンドル(80)の間で軸
方向に延びるものである前記駆動機構。
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EP13163078.2 | 2013-04-10 | ||
EP13163078 | 2013-04-10 | ||
PCT/EP2014/056978 WO2014166900A1 (en) | 2013-04-10 | 2014-04-08 | Automatic drug injection device with sophisticated drive mechanism |
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JP2016518185A JP2016518185A (ja) | 2016-06-23 |
JP6400078B2 true JP6400078B2 (ja) | 2018-10-03 |
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US (1) | US10149947B2 (ja) |
EP (1) | EP2983736B1 (ja) |
JP (1) | JP6400078B2 (ja) |
CN (1) | CN105102018B (ja) |
DK (1) | DK2983736T3 (ja) |
HK (1) | HK1215405A1 (ja) |
WO (1) | WO2014166900A1 (ja) |
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2014
- 2014-04-08 DK DK14715614.5T patent/DK2983736T3/da active
- 2014-04-08 CN CN201480019970.4A patent/CN105102018B/zh not_active Expired - Fee Related
- 2014-04-08 US US14/782,705 patent/US10149947B2/en not_active Expired - Fee Related
- 2014-04-08 WO PCT/EP2014/056978 patent/WO2014166900A1/en active Application Filing
- 2014-04-08 JP JP2016506884A patent/JP6400078B2/ja not_active Expired - Fee Related
- 2014-04-08 EP EP14715614.5A patent/EP2983736B1/en active Active
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EP2983736B1 (en) | 2020-07-01 |
WO2014166900A1 (en) | 2014-10-16 |
EP2983736A1 (en) | 2016-02-17 |
US20160067417A1 (en) | 2016-03-10 |
CN105102018A (zh) | 2015-11-25 |
CN105102018B (zh) | 2019-07-05 |
JP2016518185A (ja) | 2016-06-23 |
HK1215405A1 (zh) | 2016-08-26 |
DK2983736T3 (da) | 2020-09-21 |
US10149947B2 (en) | 2018-12-11 |
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