JP6734862B2 - 駆動機構およびそれを有する薬物送達デバイス - Google Patents
駆動機構およびそれを有する薬物送達デバイス Download PDFInfo
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- JP6734862B2 JP6734862B2 JP2017548335A JP2017548335A JP6734862B2 JP 6734862 B2 JP6734862 B2 JP 6734862B2 JP 2017548335 A JP2017548335 A JP 2017548335A JP 2017548335 A JP2017548335 A JP 2017548335A JP 6734862 B2 JP6734862 B2 JP 6734862B2
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- dose
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- 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
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- 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
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- 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)
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。
11 最小止め具
12 最大止め具
20 カートリッジホルダ
21 スナップフック
30 シャーシ(ベース要素)
31 スプライン歯
32 支承部
33 第1の湾曲した案内セクション
34 第2のまっすぐな案内セクション
35 受け取りセクション
36 クリッカアーム
37 傾斜
40 用量ボタン
41 スナップフック
50 ダイヤル(用量設定部材)
51 ダイヤルカバー
52 のこぎり歯
53 スプライン
60 最終用量ナット
61 溝
62 外側のねじ山
63 端部止め具
70 ダイヤルギヤ(連結要素)
71 ねじ山
72 止め具
73 歯
74、74’ 歯
75 スプライン
76 スロット
77 クリッカアーム
78 切抜き
80 トリガばね
90 プリズム
100 数字ホイール(ディスプレイ)
101 最大止め具
102 最小止め具
110 駆動ギヤ
111 スプライン
112、112’ 歯
113 スプライン歯
114 ピニオン
115 ラチェット
116 位置機能
120 可撓性のピストンロッド
121 区間(剛性ロッド片)
122 ヒンジ
123 ラック歯
124 フランジ
125 末端
130 駆動ばね
140 カートリッジ
141 栓
150 カムリング
151 スプライン
152 のこぎり歯
153 スプライン
160 アセンブリツール
Claims (15)
- 円筒形のカートリッジ(140)を有する薬物送達デバイス内で使用するための駆動機構であって、
ベース要素(30)と、
円形の押さえ(125)を含む第1の剛性ロッド片と、いくつかのさらなる剛性ロッド片(121)とからなり、該ベース要素(30)内で案内され、該ベース要素に対して可動である歯付きピストンロッド(120)と、
ピニオン(114)を有する駆動ギヤ(110)であって、ベース要素(30)内で回転可能に保持され、歯付きピストンロッド(120)とメッシュ係合する、駆動ギヤとを含み、
ここで、歯付きピストンロッド(120)は、ヒンジ(122)によって連結された複数の剛性ロッド片(121)を含んでいて、該剛性ロッド片(121)は、まっすぐな歯付きラック(123)を備える平板を含み、ここで、さらなる剛性ロッド片(121)はそれぞれ、まっすぐな歯付きラック(123)を備える平板と、まっすぐな歯付きラック(123)の反対側に位置する1つのフランジ(124)とからなり、および
平板は、まっすぐな歯付きラック(123)とともに、押さえ(125)の中心からずれて位置し、および
剛性ロッド片(121)の外寸は、さらなる剛性ロッド片(121)のそれぞれが、フランジ(124)の2つの軸方向に延びる縁部および平板の2つの軸方向に延びる縁部によって、カートリッジ(140)内で案内されるように、カートリッジ(140)の内寸に適合され、および、
剛性ロッド片(121)の端面は平面であり、可撓性のピストンロッド(120)がまっすぐになったとき、剛性ロッド片(121)の隣接面が互いに当接することを特徴とする、前記駆動機構。 - 軸方向における第1の剛性ロッド片の長さは、軸方向におけるさらなる剛性ロッド片(121)のそれぞれの長さを超える、請求項1に記載の駆動機構。
- ベース要素(30)は、第1の湾曲した案内セクション(33)および第2のまっすぐな案内セクション(34)を含み、駆動ギヤ(110)のピニオン(114)は、第2の
まっすぐな案内セクション(34)内へ突出するように配置される、請求項1または2に記載の駆動機構。 - ベース要素(30)は、カートリッジ(140)を保持する受け取りセクション(35)を含む、請求項1〜3のいずれか1項に記載の駆動機構。
- 第2のまっすぐな案内セクション(34)は、受け取りセクション(35)に隣接して位置する、請求項3または4に記載の駆動機構。
- ベース要素(30)は、略円形の構成を有し、ピニオン(114)は、ベース要素(30)の中心に位置し、第1の湾曲した案内セクション(33)および第2のまっすぐな案内セクション(34)は、ベース要素(30)の中心からずれて位置する、請求項3〜5のいずれか1項に記載の駆動機構。
- 駆動ギヤ(110)のスプライン連結部分(113)およびベース要素(30)の対応するスプライン連結部分(31)によって提供されるクラッチをさらに含み、ここで、駆動ギヤ(110)は、クラッチの係合によって駆動ギヤ(110)がベース要素(30)に回転方向に拘束される第1の位置と、クラッチが係合解除され、ベース要素(30)と駆動ギヤ(110)との間の相対回転が可能になる第2の位置との間で、その回転軸に沿って軸方向に可動である、請求項1〜6のいずれか1項に記載の駆動機構。
- ベース要素(30)と駆動ギヤ(110)との間に介在する圧縮ばね(80)をさらに含み、該ばね(80)は、駆動ギヤ(110)をベース要素(30)に対してその第1の位置内へ付勢する、請求項7に記載の駆動機構。
- 駆動ばね(130)をさらに含み、該駆動ばねは、一方の端部でベース要素(30)に固定されており、少なくとも駆動ギヤ(110)がベース要素(30)に対して回転することが可能にされたとき、駆動ギヤ(110)をベース要素(30)に対して回転させるための力またはトルクを駆動ギヤ(110)に及ぼし、該回転の結果、歯付きピストンロッド(120)の動きが生じる、請求項1〜8のいずれか1項に記載の駆動機構。
- 薬剤の使用者可変用量を設定する用量設定部材(50)と、該用量設定部材(50)によって設定された用量を示すディスプレイ(100)と、駆動ギヤ(110)と用量設定部材(50)との間に介在する少なくとも1つの連結部材(70)とをさらに含む、請求項1〜9のいずれか1項に記載の駆動機構を含む薬物送達デバイス。
- ベース要素(30)と堅く固定されたハウジング(10、20)をさらに含み、該ハウジングは、薬剤を収容するカートリッジ(140)を受け取るためのコンパートメントによって画成された長手方向軸を有し、用量設定部材(50)は、ハウジング(10、20)内で回転可能に配置され、その回転軸は、ハウジング(10、20)の長手方向軸に直交している、請求項10に記載の薬物送達デバイス。
- 用量設定部材(50)、連結要素(70)、および/またはディスプレイ(100)の回転は、最小用量位置および最大用量位置を画成する回転止め具(11、102;12、101)によって制限される、請求項10または11に記載の薬物送達デバイス。
- 用量設定部材(50)の回転軸の方向に軸方向に可動のトリガ(40)をさらに含み、ここで、該トリガ(40)の作動の結果、駆動ギヤ(110)および連結要素(70)の軸方向運動が生じ、駆動ギヤ(110)およびベース要素(30)が回転方向にデカップリングされる、請求項10〜12のいずれか1項に記載の薬物送達デバイス。
- 用量投薬の終了時に可聴および/または触覚フィードバックを生成するフィードバック機構をさらに含み、該フィードバック機構は、ベース要素(30)および連結部材(70)の一方の上に位置する傾斜機能(37)と、ベース要素(30)および連結部材(70)の他方の上に位置する可撓性のクリッカアーム(77)とを含み、連結部材(70)は、用量設定および用量補正位置と用量投薬位置との間で、用量設定部材(50)の回転軸に沿って軸方向に可動である、請求項10〜13のいずれか1項に記載の薬物送達デバイス。
- 薬剤を収容するカートリッジ(140)を受け取るためのコンパートメントによって画成される長手方向軸を有するハウジング(10、20)と、用量設定および/または用量投薬中に第2の軸の周りで回転する構成要素部材を有する歯付きピストンロッド(120)を駆動するための用量設定および駆動機構とを含み、ここで、第2の軸は、ハウジング(10、20)の長手方向軸に直交しており、用量設定および駆動機構は、用量投薬中に歯付きピストンロッド(120)を駆動する力またはトルクを及ぼす駆動ばね(130)をさらに含むことを特徴とする、請求項10〜14のいずれか1項に記載の薬物送達デバイス。
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US10478562B2 (en) * | 2013-04-10 | 2019-11-19 | Sanofi | Drive mechanism of a drug delivery device |
EP3229865B1 (en) | 2014-12-08 | 2020-06-03 | Sanofi | Drive mechanism and drug delivery device herewith |
-
2015
- 2015-12-08 EP EP15805208.4A patent/EP3229865B1/en active Active
- 2015-12-08 WO PCT/EP2015/078903 patent/WO2016091841A1/en active Application Filing
- 2015-12-08 DK DK15805208.4T patent/DK3229865T3/da active
- 2015-12-08 CN CN201580066438.2A patent/CN107106773B/zh active Active
- 2015-12-08 JP JP2017548335A patent/JP6734862B2/ja active Active
- 2015-12-08 US US15/532,795 patent/US10918799B2/en active Active
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EP3229865B1 (en) | 2020-06-03 |
HK1244737A1 (zh) | 2018-08-17 |
EP3229865A1 (en) | 2017-10-18 |
DK3229865T3 (da) | 2020-08-24 |
US20170340834A1 (en) | 2017-11-30 |
JP2017537760A (ja) | 2017-12-21 |
CN107106773B (zh) | 2020-10-30 |
WO2016091841A1 (en) | 2016-06-16 |
US10918799B2 (en) | 2021-02-16 |
CN107106773A (zh) | 2017-08-29 |
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