JP6465861B2 - ハンドヘルド薬物注射デバイスおよびそのための用量設定リミッタ機構 - Google Patents
ハンドヘルド薬物注射デバイスおよびそのための用量設定リミッタ機構 Download PDFInfo
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- A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
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- 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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- A61M5/31—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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- 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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- A61M5/178—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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- A61M5/178—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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- 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
- A61M5/31541—Means preventing setting of a dose beyond the amount remaining in the cartridge
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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
- A61M5/31545—Setting modes for dosing
- A61M5/31548—Mechanically operated dose setting member
- A61M5/31556—Accuracy improving means
- A61M5/31558—Accuracy improving means using scaling up or down transmissions, e.g. gearbox
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- A61M5/178—Syringes
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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
- A61M5/31548—Mechanically operated dose setting member
- A61M5/31563—Mechanically operated dose setting member interacting with a displaceable stop member
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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 (14)
- 薬剤の用量を投薬するための薬物送達デバイスの駆動機構であって:
ハウジング(20)と、
カートリッジ(12)のピストン(14)と動作可能に係合するように軸方向(1、2)に延びるピストンロッド(120)と、
該ピストンロッド(120)を少なくとも一部取り囲む、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)であって、用量の設定のためにピストンロッド(120)から動作可能に解放可能であり、用量の投薬のためにピストンロッド(120)と動作可能に係合可能である駆動スリーブ(90)と、
該駆動スリーブ(90)とねじ係合され、ハウジング(20)に回転可能にロックされ、ピストンロッド(120)に対する駆動スリーブ(90)の回転に応答して軸方向(1、2)で変位可能である用量制限部材(130)と、
最大用量構成に達したときに、ピストンロッド(120)に対する駆動スリーブ(90)のさらなる変位を妨げるために、用量制限部材(130)に係合するようにピストンロッド(120)に提供された少なくとも1つの止め部材(124)とを含み、
用量制限部材(130)は、ピストンロッド(120)の対応する形状の軸方向に延びる溝(122)と係合される少なくとも1つの半径方向内側に延びる突出部(135)を含む、
前記駆動機構。 - 用量制限部材(130)は、駆動スリーブ(90)とピストンロッド(120)との間で半径方向に配置される請求項1に記載の駆動機構。
- 用量制限部材(130)は、ピストンロッド(120)を取り囲むスリーブ部分(132)を含む請求項1または2に記載の駆動機構。
- スリーブ部分(132)は、駆動スリーブ(90)の雌ねじ(95)と係合される雄ねじ(133)を含む請求項3に記載の駆動機構。
- 用量制限部材(130)は、軸方向(1、2)に延び、駆動スリーブ(90)の近位端
から少なくとも部分的に突出するブラケット部分(137)を含む請求項1〜4のいずれか1項に記載の駆動機構。 - ブラケット部分(137)は、2つの軸方向に延びて平行に向けられた分岐部(138、139)を含み、該分岐部は、ハウジング(20)のピンを摺動可能に受け入れるように動作可能な閉じたフレーム構造を形成するように相互連結される請求項5に記載の駆動機構。
- 止め部材(124)は、ピストンロッド(120)の近位端に、半径方向外側に延びるフランジ部分を含む請求項1〜6のいずれか1項に記載の駆動機構。
- 止め部材(124)は、用量制限部材(130)の対応する歯車付きの近位リム(136)と嵌合するために、遠位方向(1)に面する冠歯車(128)を含む請求項1〜7のいずれか1項に記載の駆動機構。
- 駆動スリーブ(90)は、ばね要素(110)の作用に反して遠位方向(1)に軸方向で変位可能であり、ばね要素(110)は、駆動スリーブ(90)の近位リム(93)と、ピストンロッド(120)に回転可能に係合された駆動ホイール(100)との間に軸方向で挟まれる請求項1〜8のいずれか1項に記載の駆動機構。
- 駆動ホイール(100)は、ピストンロッド(120)とねじ係合される請求項9に記載の駆動機構。
- 駆動スリーブ(90)は、駆動ホイール(100)の対応する形状の冠歯車部分(106)と嵌合するために遠位端面に冠歯車部分(94)を含む請求項9または10に記載の駆動機構。
- 駆動スリーブ(90)の近位リム(93)は、ばね要素(78)の作用に反して用量増分方向(5)へ回転可能にハウジング(20)内で支持された駆動スピンドル(80)のピニオン(86)と噛合される請求項9〜11のいずれか1項に記載の駆動機構。
- 駆動ホイール(100)は、駆動ホイール(100)が用量投薬方向に回転するときに可聴クリック音を発生するように動作可能であり、かつ反対方向での駆動ホイール(100)の回転を妨げるようにさらに動作可能であるハウジング(20)のラチェット部材(32)と係合された歯車付きリム(102)を含む請求項9〜12のいずれか1項に記載の駆動機構。
- 請求項1〜13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。
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EP13163080 | 2013-04-10 | ||
EP13163080.8 | 2013-04-10 | ||
PCT/EP2014/056982 WO2014166904A1 (en) | 2013-04-10 | 2014-04-08 | Hand-held drug injection device and dose setting limiter mechanism therefor |
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CN (1) | CN105102021B (ja) |
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EP3200863B1 (en) | 2014-09-29 | 2020-11-04 | Dermira, Inc. | Device for dispensing a drug |
IL295010A (en) | 2015-03-10 | 2022-09-01 | Regeneron Pharma | System and method of piercing without contamination |
US10086145B2 (en) * | 2015-09-22 | 2018-10-02 | West Pharma Services Il, Ltd. | Rotation resistant friction adapter for plunger driver of drug delivery device |
JP7044708B2 (ja) | 2015-10-09 | 2022-03-30 | ウェスト ファーマ サービシーズ イスラエル リミテッド | カスタマイズシリンジの充填方法 |
HUE064866T2 (hu) * | 2016-03-21 | 2024-04-28 | Lilly Co Eli | Orvosi adagoló eszköz tengelyirányban kinyújtható meghajtóelemmel |
AU2018260992B9 (en) | 2017-05-05 | 2024-02-15 | Regeneron Pharmaceuticals, Inc. | Auto-injector |
EP4069338A1 (en) * | 2019-12-06 | 2022-10-12 | Sanofi | Dosing mechanism with rotational end stop mechanism for terminating dose dispense |
IT202100012020A1 (it) * | 2021-05-11 | 2022-11-11 | Stevanato Group Spa | Dispositivo di iniezione di un farmaco |
USD1007676S1 (en) | 2021-11-16 | 2023-12-12 | Regeneron Pharmaceuticals, Inc. | Wearable autoinjector |
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ZA941881B (en) * | 1993-04-02 | 1995-09-18 | Lilly Co Eli | Manifold medication injection apparatus and method |
DE10163328B4 (de) | 2001-07-30 | 2005-08-11 | Tecpharma Licensing Ag | Verabreichungsgerät mit Verdrehsicherung |
DE102004063647A1 (de) | 2004-12-31 | 2006-07-20 | Tecpharma Licensing Ag | Vorrichtung zur dosierten Verabreichung eines fluiden Produkts mit Kupplung |
US9101722B2 (en) * | 2005-02-28 | 2015-08-11 | Novo Nordisk A/S | Dose setting mechanism for an injection device capable of presetting a maximum dose |
ES2361563T5 (es) * | 2005-07-27 | 2016-03-22 | Novo Nordisk A/S | Mecanismo de dosificación para un dispositivo de inyección para limitar un ajuste de dosis que corresponde a la cantidad de medicamento restante |
DE102005060929A1 (de) | 2005-09-14 | 2007-03-15 | Tecpharma Licensing Ag | Injektionsvorrichtung mit Zweiwege-Rutschkupplung |
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EP2219714A1 (de) | 2007-11-13 | 2010-08-25 | Tecpharma Licensing AG | Injektionsvorrichtung mit entkuppelbarem klickmechanismus |
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US7959612B2 (en) * | 2008-04-21 | 2011-06-14 | Medtronic Vascular, Inc. | Dual syringe injector system |
US8647309B2 (en) * | 2008-05-02 | 2014-02-11 | Sanofi-Aventis Deutschland Gmbh | Medication delivery device |
US8840591B2 (en) * | 2008-12-12 | 2014-09-23 | Sanofi-Aventis Deutschland Gmbh | Drive mechanism for a medication delivery device and medication delivery device |
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JP2016518186A (ja) | 2016-06-23 |
EP2983742A1 (en) | 2016-02-17 |
EP2983742B1 (en) | 2019-06-12 |
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US10226581B2 (en) | 2019-03-12 |
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