JP5690818B2 - 螺旋スプラインを有する薬物送達デバイス内部ハウジング - Google Patents
螺旋スプラインを有する薬物送達デバイス内部ハウジング Download PDFInfo
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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
- 210000003462 vein Anatomy 0.000 description 1
Images
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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
- 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
- A61M5/31525—Dosing
-
- 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
- A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
- A61M5/16877—Adjusting flow; Devices for setting a flow rate
-
- 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
- A61M5/178—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
-
- 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
- A61M5/178—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
-
- 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
- A61M5/178—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
- A61M5/3155—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe
- A61M5/31551—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe including axial movement of dose setting member
-
- 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
- A61M5/178—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
- A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
- A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
- A61M5/31583—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
-
- 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
- A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
- A61M2205/581—Means for facilitating use, e.g. by people with impaired vision by audible feedback
-
- 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
- A61M5/178—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
- A61M5/31543—Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose piston rod reset means, i.e. means for causing or facilitating retraction of piston rod to its starting position during cartridge change
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- General Health & Medical Sciences (AREA)
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- Fluid Mechanics (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Description
ここで一実施態様において、薬学的に活性な化合物は、最大で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、抗体、酵素、抗体、ホルモン、若しく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、関節リウマチの治療、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治療、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、又はエキセンジン−3又はエキセンジン−4、若しくはエキセンジン−3又はエキセンジン−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[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−末端と連結してもよく;
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;
又は前述のいずれかのエキセンジン−4誘導体の薬学的に許容可能な塩若しくは溶媒和物;
から選択される。
Publishing社,Easton, Pa., U.S.A.,1985 及び Encyclopedia of Pharmaceutical Technologyに記載されている。
(二つの部分で作られるか又はただ一つの一体物部品で作られるか)ドライバー209も、平らな内部貫通孔プラス軸方向に動くコアピンを有して成形することができるねじ形態を有して作ることができる。これによって、一回より多い回転(turn)を持つ内部ねじを有し、従って成形品取り出し工程中に数回回転されて出てくるコアピンが要求される、ドライバーの不利な点が避けられる。
Claims (18)
- 薬物送達デバイス用の用量設定機構であって、該機構は:
外部ハウジング;
外部溝を有する内部ハウジング、ここで該内部ハウジングが、該用量設定機構によって設定された用量を投与するべく、ドライバーを誘導するように構成され;及び
上記外部ハウジングと上記内部ハウジングの間に配列されたダイアルスリーブ、ここで該ダイアルスリーブが、上記内部ハウジングの上記外部溝と回転可能に係合し、
ここで、該ダイアルスリーブが、用量設定中に、上記外部ハウジング及び上記内部ハウジングの両方に対して回転するように構成され、そして上記外部ハウジングと上記内部ハウジングの両方から離れて並進されるように構成される;を含み、
内部ハウジングが内部螺旋スプラインを含むことを特徴とする、用量設定機構。 - 前記内部螺旋スプラインが、用量投与中の螺旋運動において、前記ドライバーを誘導するように構成される、請求項1に記載の用量設定機構。
- 前記ドライバーが第一のドライバー部分及び第二のドライバー部分を含み、ここで該第一のドライバー部分及び該第二のドライバー部分が、複数のドライバー部品を含む、請求項1又は2に記載の用量設定機構。
- 用量制限器を更に含む、請求項1〜3の何れか一つに記載の用量設定機構であって、該用量制限器が前記内部ハウジングの前記螺旋スプラインにスプラインされる、用量設定機構。
- 前記用量制限器が、前記ドライバー上に供された螺旋溝に動作可能なように連結される内部螺旋溝を含む、請求項4に記載の用量設定機構。
- クリッカーを更に含む、請求項1〜5の何れか1項に記載の用量設定機構。
- 前記クリッカーが、螺旋運動において前記ドライバーを誘導し、そして前記クリッカーが前記内部ハウジング内に存在する、請求項6に記載の用量設定機構。
- 前記クリッカーが第一のクリッカー部分及び第二のクリッカー部分を含む請求項6又は7に記載の用量設定機構であって、ここで前記第一のクリッカー部分が、前記第二のクリッカー部分のクリッカー歯の第二のセットを係合するように構成されるクリッカー歯の第一のセットを含む、用量設定機構。
- 前記クリッカー又は前記第一のクリッカー部分が、前記内部ハウジングの前記螺旋スプラインに係合するように構成された少なくとも一つの前記スプラインを含む、請求項6〜8の何れか1項に記載の用量設定機構。
- 前記クリッカーが、クラッチと回転的に係合されるクリッカー歯の第一のセットを含む、請求項6〜9の何れか1項に記載の用量設定機構。
- 前記クリッカーが前記ドライバーに軸方向に固定される、請求項6〜10の何れか1項に記載の用量設定機構。
- 前記クリッカーが、用量設定工程中に回転するために、及び/又は投与工程中に回転するように構成される、及び/又は、前記用量設定機構が、リセット工程中に回転するために、リセット可能な用量設定機構を含む、請求項6〜11の何れか1項に記載の用量設定機構。
- スピンドルを更に含む、請求項1〜12の何れか1項に記載の用量設定機構で あって、
前記用量設定機構によって設定された前記用量を投与するために、前記内部ハウジングが前記ドライバーを誘導するとき、
前記ドライバーが前記スピンドルを押してカートリッジ栓上に作用し、一方、前記カートリッジから前記用量を排出するために、前記スピンドルが遠位方向に並進するように、
前記スピンドルが動作可能なように前記ドライバーに連結される、用量設定機構。 - 前記スピンドルが第一の及び第二の螺旋溝を含む、請求項13に記載の用量設定機構。
- 前記スピンドルが、用量設定工程中に回転しないように、及び/又は投与工程中に回転するように、及び/又はリセット工程中に回転するように構成される、請求項13又は14に記載の用量設定機構。
- 薬物送達デバイス用の用量設定機構であって:
外部ハウジング;
外部溝及び螺旋スプラインを有する内部ハウジング、ここで前記内部ハウジングの前記螺旋スプラインが、前記内部ハウジングの内部表面上に位置付けられ;
前記内部ハウジングの前記外部溝に連結された用量スリーブ;
用量設定工程中に前記用量ダイアルスリーブに回転的に連結されたドライバー;
前記内部ハウジングの前記螺旋スプラインに回転的に連結される少なくとも一つのリブを含む連結部材;を含んでなり、
それにより、前記用量設定工程中に、前記用量スリーブ及び前記ドライバーが共に回転し、前記用量スリーブが前記内部ハウジング上の前記外部溝に追随し、そして前記連結器が前記螺旋スプライン上を外に回転し、そして前記ダイアルスリーブ及びドライバーに対して回転することが可能になり;
そして用量投与工程中に、前記ドライバーが回転的に前記ダイアルスリーブから連結解除されそして回転的に前記連結器と連結されるようになり;
前記連結器が、前記内部ハウジングに対して軸方向に動かないように、そして、前記用量設定工程と前記用量投与工程の間で、又は前記用量投与工程と前記用量設定工程の間で、前記用量設定機構が動かされるとき、前記ドライバーを回転しないように構成されることを特徴とする用量設定機構。 - 少なくとも1つの薬学的に活性な化合物を含有する医薬製剤を含むカートリッジから投薬される薬剤の用量を設定するために設けられる、請求項1〜16の何れか1項に記載の用量設定機構。
- 薬学的に活性な化合物が、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、又はエキセンジン−3又はエキセンジン−4、又はエキセンジン−3若しくはエキセンジン−4の類似体若しくは誘導体を含む、請求項17に記載の用量設定機構。
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US18286409P | 2009-06-01 | 2009-06-01 | |
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