JP2012528633A - 薬物送達デバイス用の用量設定機構 - Google Patents
薬物送達デバイス用の用量設定機構 Download PDFInfo
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- JP2012528633A JP2012528633A JP2012513574A JP2012513574A JP2012528633A JP 2012528633 A JP2012528633 A JP 2012528633A JP 2012513574 A JP2012513574 A JP 2012513574A JP 2012513574 A JP2012513574 A JP 2012513574A JP 2012528633 A JP2012528633 A JP 2012528633A
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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
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01D—MEASURING NOT SPECIALLY ADAPTED FOR A SPECIFIC VARIABLE; ARRANGEMENTS FOR MEASURING TWO OR MORE VARIABLES NOT COVERED IN A SINGLE OTHER SUBCLASS; TARIFF METERING APPARATUS; MEASURING OR TESTING NOT OTHERWISE PROVIDED FOR
- G01D13/00—Component parts of indicators for measuring arrangements not specially adapted for a specific variable
- G01D13/02—Scales; Dials
- G01D13/12—Graduation
-
- 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
- A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
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- Vascular Medicine (AREA)
- Engineering & Computer Science (AREA)
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- Heart & Thoracic Surgery (AREA)
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- Life Sciences & Earth Sciences (AREA)
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- Infusion, Injection, And Reservoir Apparatuses (AREA)
Abstract
【選択図】図11
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、又は上述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。
味する。
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−末端と結合してもよく;
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。
rk Publishing社,Easton, Pa., U.S.A.,1985 及び Encyclopedia of Pharmaceutical Technologyに記載されている。
Claims (14)
- 薬物のカートリッジ(25)を備えた薬物送達デバイス(1)、好ましくはペン型の薬物送達デバイス、用の用量設定機構であって、用量設定機構(4)が、該カートリッジ(25)から投与すべき薬物の用量を選択するために操作可能であり、用量設定機構(4)が:
軸(30);
該軸(30)の第一の部分(32)に沿って備え付けられた第一のピッチを有する螺旋溝(32);及び
該軸(30)の該螺旋溝(32)上に配列されるナット部材(40)であって、
上記薬物送達デバイスの用量設定中、該軸(30)が、該ナット部材(40)に対して回転し、同時に該ナット部材(40)が、該軸(30)の第一の端部(38)から該軸(30)の第二の端部(39)に向かって、該螺旋溝(32)に沿って縦方向に進む、該ナット部材(40);及び
該用量設定機構(4)の使用者が、上記カートリッジ(25)中に残っている薬物よりも多い該薬物の用量を設定することを防ぐ手段であって、上記軸(30)の第二の部分(36)に沿って備え付けられた第二のピッチを含んでなり、上記第一のピッチが該第二のピッチとは異なる、好ましくは該第二のピッチが該第一のピッチより大きい、該手段;
を含んでなる:
上記用量設定機構。 - 請求項1に記載の機構であって、軸(30)及びナット部材(40)の相対的な動きが、互いに対して軸(30)及びナット部材(40)の出発位置(52)及び停止位置(62)を含んでなり、ここで該出発位置(52)と該停止位置(62)の間のナット部材(40)の軸(30)に沿った移動距離が、前記カートリッジ(25)中に含有された薬物の量に対応する、上記機構。
- 請求項1または2に記載の機構であって、前記用量が前記カートリッジ(25)から投与されるとき、前記ナット部材(40)が、軸(30)に対して回転せず、むしろ該ナット部材(40)及び該軸(30)の両者が実質的に軸方向に動き、ここで、該ナット部材(40)が、好ましくは少なくとも一つのスプライン機構(44)を含んでなり、少なくとも一つの該スプライン機構(44)が、該ナット部材(40)と、前記薬物送達デバイス(1)のハウジングとの間の相対的な回転を防ぐ、上記機構
- 請求項1〜3の何れか1項に記載の機構であって、前記ナット部材(40)が不完全ねじ部(46)、好ましくは二つの出発ねじの二つの半回転を含んでなる、上記機構。
- 請求項1〜4の何れか1項に記載の機構であって、前記第一の部分が前記軸(30)の近位端(38)近くに位置し、そして前記第二の部分が該軸(30)の遠位端(39)近くに位置する、上記機構。
- 請求項1〜5の何れかに記載の機構であって、前記ナット部材(40)は、少なくとも一つの実質的に半径方向の停止面(42)を含んでなり、ここで、該ナット部材(40)は、少なくとも一つの実質的に半径方向の該停止面(42)が、前記軸(30)上の少なくとも一つの実質的に半径方向の停止面(43)と係合して、該軸(30)が該ナット部材(40)に対して回転することを防ぐ、上記機構。
- 請求項6に記載の機構であって、前記ナット部材(40)が複数の実質的半径方向の停止面(42)を含んでなり、ここで、複数の該停止面(42)が前記軸(30)上の複数の実質的半径方向の停止面(43)と係合する、上記機構。
- 請求項1〜7の何れか1項に記載の機構であって、前記薬物送達デバイス(1)が再使用不可能なペン型の薬物送達デバイスを含む、上記機構。
- 請求項1〜8の何れか1項に記載の機構であって、前記軸(30)の第三の部分(35)に沿って備えられた第三のピッチを更に含み、ここで該軸(30)の前記第一の部分(34)に沿って備えられた前記第一のピッチが、好ましくは該第三のピッチと略等しい、上記機構。
- 請求項9に記載の機構であって、前記軸(30)の前記第三の部分(35)に沿って備えられた前記第三のピッチが、前記ナット部材(40)のねじ山に類似する、上記機構。
- 請求項1〜10の何れか1項に記載の機構であって、前記ナット部材(40)が完全な円形ナットである、上記機構。
- 請求項1〜11の何れか1項に記載の機構であって、軸(30)が前記第一の部分(4)に対して回転した後ナット部材(40)が停止位置(62)に達するとき、第二の部分(36)が、回転の最後の45〜360度に対応する位置から始まる、上記機構。
- 請求項1〜12の何れか1項に記載の機構であって、前記軸の前記第一の端部(38)が遠位端を含んでなり、そして該軸の前記第二の端部(39)が近位端を含む、上記機構。
- 請求項1〜13の何れか1項に記載の機構であって、軸(30)が回転可能であり、そしてナット部材(40)が非回転である、上記機構。
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JP2016514590A (ja) * | 2013-04-10 | 2016-05-23 | サノフイ | 薬物送達デバイスの駆動機構 |
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JP2017530795A (ja) * | 2014-10-09 | 2017-10-19 | サノフイ | 異なるリードおよび多条ねじ山セクションを有する薬物送達デバイス用の用量投入アセンブリ |
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Also Published As
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EP2437829A1 (en) | 2012-04-11 |
NZ596701A (en) | 2013-03-28 |
KR20120028316A (ko) | 2012-03-22 |
JP5717729B2 (ja) | 2015-05-13 |
CA2762043C (en) | 2017-10-10 |
AU2010255820B2 (en) | 2014-08-21 |
RU2011154135A (ru) | 2013-07-20 |
BRPI1011678A2 (pt) | 2016-03-22 |
RU2519966C2 (ru) | 2014-06-20 |
ZA201107691B (en) | 2012-08-29 |
WO2010139645A1 (en) | 2010-12-09 |
CA2762043A1 (en) | 2010-12-09 |
US8790315B2 (en) | 2014-07-29 |
BRPI1011678B1 (pt) | 2019-11-12 |
PL2437829T3 (pl) | 2017-12-29 |
US9199040B2 (en) | 2015-12-01 |
AU2010255820A1 (en) | 2011-12-22 |
US20100324494A1 (en) | 2010-12-23 |
IL216433A (en) | 2015-10-29 |
KR101843716B1 (ko) | 2018-03-30 |
HUE034744T2 (en) | 2018-02-28 |
US20120165751A1 (en) | 2012-06-28 |
MX2011012213A (es) | 2011-12-08 |
SG176076A1 (en) | 2011-12-29 |
CN102458535A (zh) | 2012-05-16 |
DK2437829T3 (da) | 2017-11-06 |
MY160285A (en) | 2017-02-28 |
CN102458535B (zh) | 2014-08-20 |
IL216433A0 (en) | 2012-03-01 |
ES2639736T3 (es) | 2017-10-30 |
NO2437829T3 (ja) | 2017-12-16 |
EP2437829B1 (en) | 2017-07-19 |
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