JP2014528784A - 薬物送達デバイスの作動を監視するための方法及び監視デバイス - Google Patents
薬物送達デバイスの作動を監視するための方法及び監視デバイス Download PDFInfo
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- 108010004367 lixisenatide Proteins 0.000 description 1
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- 229940055729 papain Drugs 0.000 description 1
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- 230000008569 process Effects 0.000 description 1
- 125000001500 prolyl group Chemical group [H]N1C([H])(C(=O)[*])C([H])([H])C([H])([H])C1([H])[H] 0.000 description 1
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- 241000894007 species Species 0.000 description 1
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- CIJQTPFWFXOSEO-NDMITSJXSA-J tetrasodium;(2r,3r,4s)-2-[(2r,3s,4r,5r,6s)-5-acetamido-6-[(1r,2r,3r,4r)-4-[(2r,3s,4r,5r,6r)-5-acetamido-6-[(4r,5r,6r)-2-carboxylato-4,5-dihydroxy-6-[[(1r,3r,4r,5r)-3-hydroxy-4-(sulfonatoamino)-6,8-dioxabicyclo[3.2.1]octan-2-yl]oxy]oxan-3-yl]oxy-2-(hydroxy Chemical class [Na+].[Na+].[Na+].[Na+].O([C@@H]1[C@@H](COS(O)(=O)=O)O[C@@H]([C@@H]([C@H]1O)NC(C)=O)O[C@@H]1C(C[C@H]([C@@H]([C@H]1O)O)O[C@@H]1[C@@H](CO)O[C@H](OC2C(O[C@@H](OC3[C@@H]([C@@H](NS([O-])(=O)=O)[C@@H]4OC[C@H]3O4)O)[C@H](O)[C@H]2O)C([O-])=O)[C@H](NC(C)=O)[C@H]1C)C([O-])=O)[C@@H]1OC(C([O-])=O)=C[C@H](O)[C@H]1O CIJQTPFWFXOSEO-NDMITSJXSA-J 0.000 description 1
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- VXKHXGOKWPXYNA-PGBVPBMZSA-N triptorelin Chemical compound C([C@@H](C(=O)N[C@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N1[C@@H](CCC1)C(=O)NCC(N)=O)NC(=O)[C@H](CO)NC(=O)[C@H](CC=1C2=CC=CC=C2NC=1)NC(=O)[C@H](CC=1N=CNC=1)NC(=O)[C@H]1NC(=O)CC1)C1=CC=C(O)C=C1 VXKHXGOKWPXYNA-PGBVPBMZSA-N 0.000 description 1
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Images
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- G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
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Abstract
Description
ここで一つの実施態様において、薬学的に活性な化合物は、最大1500Daまでの分子量を有し、及び/又は、ペプチド、蛋白質、多糖類、ワクチン、DNA、RNA、酵素、抗体、若しくはその断片、ホルモン又はオリゴヌクレオチド、又は上記の薬学的に活性な化合物の混合物であり;
ここで、更なる実施態様において、薬学的に活性な化合物は、糖尿病、又は糖尿病性網膜症などの糖尿病関連の合併症、深部静脈又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、癌、黄斑変性症、炎症、枯草熱、アテローム性動脈硬化症、及び/又は、関節リウマチの処置、及び/又は、予防に有用であり;
ここで、更なる実施態様において、薬学的に活性な化合物は、糖尿病、又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、及び/又は、予防のための、少なくとも1つのペプチドを含み;
ここで、更なる実施態様において、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、又はヒトインスリン類似体若しくは誘導体、グルカゴン様ペプチド(GLP−1)、又はその類似体若しくは誘導体、又はエキセジン−3又はエキセジン−4、若しくはエキセジン−3又はエキセジン−4の類似体若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−4(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)14Trp(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);又は
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は、エキセンジン−4誘導体のC−末端と結合してもよく;
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;
desAsp28,Pro36,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−desAsp28 Pro36,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−des Pro36,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,Asp28,Pro36,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)5,desPro36,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−des Pro36,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;
又は前述のエキセンジン−4誘導体のいずれか1つの薬学的に許容される塩若しくは溶媒和物;
から選択される。
1:薬物送達デバイス;
2:近位方向;
3:遠位方向;
10:ハウジング;
11:注射ボタン;
12:用量ダイヤル;
13:用量窓;
14:カートリッジ;
15:ニードルアセンブリ;
16:内部ニードルキャップ;
17:外部ニードルキャップ;
18:キャップ;
19:カートリッジホルダ;
20:点検窓;
21:駆動機構;
22:音発生素子;
23:センサ;
24:音発生素子;
25:センサ;
26:ダイヤルスリーブ;
28:締結エレメント;
30:グラフ;
31:信号;
32:グラフ;
33:信号;
34:信号;
35:信号;
36:時間遅延;
40:監視デバイス;
41:信号調整回路;
42:信号調整回路;
43:タイマモジュール;
44:処理ユニット;
45:ユーザインタフェースユニット;
46:センサ;
Claims (15)
- 薬物送達デバイスの作動を監視するための監視デバイスであって、監視デバイスは:
−第一の方向(2、3)に関して互いに距離を置いて配置され、そしてデバイスの作動に応答して、第一及び第二の電気信号(31、33)を発生するように適合されている少なくとも第一及び第二のセンサ(23、25)、ここで、第一及び第二のセンサ(23、25)は、薬物送達デバイスの全く同一の検出可能な作動を検出及び/又は記録するように適合される;
−第一及び第二の電気信号(31、33)の間の時間遅延(36)を測定するように構成され、そして該時間遅延(36)に基づいて、薬物送達デバイスの少なくとも一つのパラメータを決定するように適合される処理ユニット(43、44)、
を含んでなる、上記監視デバイス。 - 第一及び/又は第二のセンサ(23、25)は、音響−、振動−、加速度−及び/又は機械的張力変換素子を含む、請求項1に記載の監視デバイス。
- 更に、閾値を超える第一及び/又は第二の電気信号(31、33)の発生を検出するように構成された少なくとも一つの回路(41、42)を含んでなる、請求項1又は2に記載の監視デバイス。
- 時間遅延(36)が、事前に定められた用量値(x)より小さいか又は等しいとき、処理ユニット(43、44)は、薬物送達デバイス(1)により設定された用量のサイズを決定するように適合される、請求項1〜3のいずれか1項に記載の監視デバイス。
- 時間遅延(36)が、事前に定められた注射値(y)に実質的に等しいとき、処理ユニット(43、44)は、薬物送達デバイス(1)の投薬動作を識別及び/又は検出するように適合される、請求項1〜4のいずれか1項に記載の監視デバイス。
- 更に、薬物送達デバイスにより設定される用量のサイズを個別に決定するための第三のセンサ(46)を含んでなる、請求項1〜5のいずれか1項に記載の監視デバイス。
- 第一及び第二のセンサ(23、25)の間の距離が、薬物送達デバイス(1)の第一及び第二の音発生素子(22、24)の間の距離より小さいか、又は等しい、請求項1〜6のいずれか1項に記載の監視デバイス。
- 第一及び/又は第二のセンサ(23、25)及び/又は処理ユニット(43、44)が、薬物送達デバイス(1)の異なった音発生素子(22、24)により発生する異なった音を識別するように適合される、請求項1〜7のいずれか1項に記載の監視デバイス。
- 更に、薬物送達デバイスのハウジング(10)に、事前に定められた方法で監視デバイスを解放可能に締結するための少なくとも一つの締結エレメント(28)を含んでなる、請求項1〜8のいずれか1項に記載の監視デバイス。
- 監視システムであって:
−ハウジング(10)、駆動機構(21)及び駆動機構(21)との相互作用を通して投薬しようとする薬剤を含むカートリッジ(14)を有する薬物送達デバイス(1)、ここで、駆動機構(21)は、ハウジング(10)に対して第一の方向(2、3)に沿って可動に配設された少なくとも一つの音発生素子(22、24)を含み、及び
−請求項1〜9のいずれか1項に記載の監視デバイス(40)、ここで、第一及び第二のセンサ(23、25)は、駆動機構(21)の作動に応答して、音発生素子(22、24)により発生された音を検出するように適合される、
を含んでなる、上記システム。 - 請求項10に記載の監視システムであって、ここで、駆動機構は、第一及び第二の音発生素子(22、24)を含み、ここで、第一の音発生素子(22)は、駆動機構(21)の用量設定動作の間、第一のクリック音を発生するように適合されており、そして第二の音発生素子(24)は、用量の投薬動作の間、第二のクリック音を発生させるように適合される、上記システム。
- 請求項10又は11に記載の監視システムであって、ここで、駆動機構(21)の少なくとも一つの音発生素子(22、24)が、第一の方向(2、3)に関して監視デバイス(40)の第一及び第二のセンサ(22、24)の間に位置するように、監視デバイス(40)は、事前に定められた位置において、薬物送達デバイス(1)のハウジング(10)に締結可能である、上記システム。
- 請求項10〜12のいずれか1項に記載の監視システムであって、ここで、第一の方向(2、3)に関して駆動機構(21)の少なくとも一つの音発生素子(22、24)が、監視デバイス(40)の第一及び第二のセンサ(22、24)の間の中間領域の外側に位置する、上記システム。
- ハウジング(10)、及びハウジング(10)に対して第一の方向(2、3)に沿って可動に配設された少なくとも一つの音発生素子(22、24)を含む駆動機構(21)を有する薬物送達デバイス(1)の作動を監視する方法であって、作動を監視する方法は:
−駆動機構(21)の作動中、音を発生させる工程、
−第一の方向(2、3)に関して互いに距離を置いて配置された第一のセンサ、及び第二のセンサにより音を検出し、そして音の検出に対応して第一及び第二の電気信号(31、33)を発生させる工程、
−第一及び第二の電気信号(31、33)の間での時間遅延(36)を測定する工程、及び
−時間遅延(36)に基づいて薬物送達デバイス(1)の少なくとも一つのパラメータを決定する工程;
を含む、上記方法。 - 時間遅延(36)の大きさが、設定用量のサイズを決定するため、及び/又は薬物送達デバイス(1)の投薬動作を識別及び/又は検出するため、事前に定められた用量及び/又は注射値(x、y)と比較する、請求項14に記載の方法。
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US20140207080A1 (en) | 2014-07-24 |
US10383998B2 (en) | 2019-08-20 |
JP6116570B2 (ja) | 2017-04-19 |
WO2013034716A1 (en) | 2013-03-14 |
EP3400981A1 (en) | 2018-11-14 |
US20190365989A1 (en) | 2019-12-05 |
EP2753387A1 (en) | 2014-07-16 |
DK2753387T3 (en) | 2018-09-10 |
EP3400981B1 (en) | 2019-12-25 |
DK3400981T3 (da) | 2020-03-16 |
CA2845396A1 (en) | 2013-03-14 |
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US11315670B2 (en) | 2022-04-26 |
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