JP4698677B2 - 巻き上げ式ペン型の薬剤送達装置のダイヤルダウン機構 - Google Patents
巻き上げ式ペン型の薬剤送達装置のダイヤルダウン機構 Download PDFInfo
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- 230000007246 mechanism Effects 0.000 title claims abstract description 59
- 238000012377 drug delivery Methods 0.000 title claims description 7
- 238000002347 injection Methods 0.000 claims abstract description 22
- 239000007924 injection Substances 0.000 claims abstract description 22
- 239000003814 drug Substances 0.000 claims abstract description 6
- 238000001802 infusion Methods 0.000 claims description 16
- 229940079593 drug Drugs 0.000 claims description 4
- 238000004804 winding Methods 0.000 description 3
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 239000013013 elastic material Substances 0.000 description 1
- 230000003993 interaction Effects 0.000 description 1
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- A61M5/31586—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 rotationally moving or pivoted actuator, e.g. an injection lever or handle
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Description
ねじりばねを採用した公知の巻き上げ式ペンの一例は、例えば米国特許第5104380号明細書に記載されている。しかしながら、米国特許第5104380号明細書に提案されているペンは、ダイヤルダウン機構を提供するものではない。ダイヤルダウン機構は国際公開第02/053214号パンフレットに記載されている。しかしながら、国際公開第02/053214号パンフレットに記載の解決策は、線形ばねを使用している。
米国特許出願第2004/199117号明細書は、ダイヤルバック機能により使用者が不適切な投薬量の設定を訂正できる薬剤投与ペンを開示している。このダイヤルバック機能は、薬剤を放出することなく、且つ投薬量ノブを余分にリセット位置までダイヤルする必要なく、投薬量のリセットを可能にするものである。米国特許出願第2004/199117号明細書に記載の薬剤送達ペンは、いわゆる手動式ペンであり、ペンからの薬剤の注入が、ペンの使用者が加える力だけで駆動される。このように、薬剤の注入には、ばねのような弾性部材が全く使用されておらず、米国特許第2004/199117号明細書に開示のダイヤルダウンの構造は、所与の撓み位置に弾性部材を保持するように構成されていない。
上記課題は、第1の態様により、注入装置からの投薬量の注入を補助するねじりばねを備えた注入装置のダイヤルダウン機構により達成される。本ダイヤルダウン機構は、
− ダイヤルアップキーを受容してこれと係合するダイヤルアップカムであって、用量設定部材を第1の方向へ回転させると、ダイヤルアップカムとダイヤルアップキーとが協働して注入装置のねじりばねに撓みを与えるダイヤルアップカム、及び
− ダイヤルダウンキーを受容してこれと係合するダイヤルダウンカムであって、第1の方向とは反対の第2の方向へ用量設定部材を回転させると、ダイヤルダウンカムとダイヤルダウンキーとが協働して注入装置のねじりばねを解放するダイヤルダウンカム
を備えている。
一般に、ダイヤルダウン機構は、半径方向のダイヤルダウン機構又は軸方向のダイヤルダウン機構として実施することができる。半径方向ダイヤルダウン機構では、1つ又は複数のダイヤルダウンキーは、機構の半径方向に運動するように構成されている。この方向は、注入装置の半径方向とすることができる。軸方向ダイヤルダウン機構では、1つ又は複数のダイヤルダウンキーは、注入装置の軸方向に運動するように構成されている。
ダイヤルアップカム及びダイヤルダウンカムは、ディスク形状のカム部材の外表面部分に配置される開口又は窪みとすることができる。別の構成では、カム部材は、実質的に円筒形の部材とすることができる。特に、ダイヤルアップカム及びダイヤルダウンカムは、カム部材の実質的に平坦な表面部分に配置することができる。この実質的に平坦な表面部分は、ディスク形状又は円筒形のカム部材の軸方向に実質的に垂直に配置することができる。カム部材は、中空構造とすることができるか、又は別の構成として中実構造とすることができる。
ダイヤルダウン機構は、第1及び第2のダイヤルアップカムを備えることができる。ダイヤルダウン機構は更に、第1及び第2のダイヤルアップキーを備えることができ、第1のダイヤルアップキーは第1のダイヤルアップカムに係合してこれと協働することができ、第2のダイヤルアップキーは、第2のダイヤルアップカムに係合してこれと協働することができる。
ダイヤルアップカムとダイヤルダウンカムは、同じ軌道の一部を形成することができる。更に、ダイヤルアップキー及びダイヤルダウンキーは、同じ軌道のダイヤルアップカム及びダイヤルダウンカムに係合して協働する同じキーにより構成することができる。
軸方向の機構では、ダイヤルアップカムは、注入装置の軸方向に実質的に平行とすることができる。付属のラチェットを歯部から解放するために、ダイヤルダウンカムは、ダイヤルアップカムと、例えば約45°の角度をなすことができる。
− 注入装置から注入される投薬量を設定する時に回転させる回転可能な部材であって、ダイヤルアップカム及びダイヤルダウンカムを備え、ダイヤルアップカムが、用量設定時に注入装置のラチェットのキーを受容してこれと係合し、ダイヤルダウンカムが、ダイヤルダウンの際に、キーを受容してこれと係合する、回転可能な部材
を備えており、ダイヤルアップカムが注入装置の軸方向と実質的に平行である。
本発明のこの第2の態様では、ダイヤルアップカム及びダイヤルダウンカムは、同じ軌道の一部を形成することができる。ダイヤルアップキー及びダイヤルダウンキーは同じキーによって構成することができ、前記キーは、同じ軌道のダイヤルアップカム及びダイヤルダウンカムに係合してこれと協働する。
本発明には、様々な変形及び変更を加えることができ、例示として特定の実施形態を図面に示し、以下に詳説する。しかしながら、本発明は、開示された特定の形態に限定されるものではない。むしろ、本発明は、特許請求の範囲によって規定される本発明の思想及び範囲に含まれる全ての変更、均等物及び変形例を含むものである。
本発明によるダイヤルダウン機構は、軸方向の機構又は半径方向の機構として実施することができる。これらの機構はいずれも、注入ペン等の注入装置に組み込むことができる。
半径方向の手段を図1に示す。図1Aは、固定された外側部分1に対して付勢されている回転可能な内側部分2を示す。付勢力は、反時計回り方向に、ねじりばね(図示せず)によって付与されている。中心軸6を中心に回転可能な内側部分2は、固定の外側部分1に形成されたエッジ5と係合する1つ以上の可撓性のアーム3を有している。図1Bは、内側部分2及び外側部分1の上に配置された回転可能なディスク7(斜線領域)を備えた図1Aの構成を示す。ディスク7は開口8を有している。開口8を画定するエッジは、ダイヤルアップカム及びダイヤルダウンカムを構成する。可撓性のアーム3に装着されているか又は組み込まれているピックアップキー4は、ディスク7が外側部分1に対して回転する時のカムフォロワとして機能する。
用量を設定する時(ダイヤルアップ)、内側部分2を時計回りの方向に回転させる。これにより、可撓性のアーム3は回転の角度に応じて、1つのエッジ5から1つ又は複数個隣のエッジへと動く。内側部分2はディスク7によって駆動される。つまり、ディスク7を回転させると、内側部分2がこれに伴って回転する。時計回りの方向に回転する際、ピックアップキー4は半径方向に沿って内外に動く。
内側部分2を反時計回りの方向に回転させることによりダイヤルアップが達成されるように、回転の方向を逆にすることも可能であることに留意されたい。この構成では、ディスク7を時計回りに回転させることによってダイヤルダウンを行うことができる。
ダイヤルダウンキー12は、可撓性のアーム19と一体である。このアームは、弾性材料、例えばプラスチックから製造されている。ダイヤルダウンキー12と一体の可撓性のアーム19はラチェット13の一体部分を形成している。つまり、アーム及びダイヤルダウンキーを含むラチェットは、好ましくは同じ材料、例えばプラスチックから製造する。ダイヤルダウンキー12をナット10の歯列20に対して付勢するために、ねじりばね18が、ラチェット13と同軸に配置される。開口21が、ナット10の中央部分に設けられている。この開口の側壁にはねじ山22が設けられており、このねじ山22は、ピストンロッド(図示せず)のねじ山を有する外表面と螺合する。
用量は、用量設定部材30及びナット32を回転させて、ねじりばね35に撓みを与えることにより設定される。ナット32と駆動部材33との間に配置されている歯付き機構37によって、用量設定部材30が初期位置に戻ることが防止されている。使用者が予め設定した用量を減らしたい場合、用量設定部材30を単に反対方向に回転させる。ダイヤルダウン時のラチェット38とナット32との相互作用については、図2を参照して説明した。
用量を設定するとき、カムフォロワ42はカム表面46に係合する。この結果、歯部48によってラチェット44の戻りが防止されるので、ねじりばね43に撓みが与えられる。ダイヤルアップ時には、歯部48の上部及び下部が互いに相対回転するのにつれて、ラチェット44がカム表面46に沿って上下に動く。ダイヤルダウンの際には、カム表面47が持ち上がることにより、歯部の下部から歯部の上部が外れ、ラチェット44は、歯部1つ分に対応する角度だけ回転することができる。
Claims (12)
- 注入装置からの1回分の投薬量の注入を補助するためのねじりばね(18)を備えた注入装置のダイヤルダウン機構であって、
− ダイヤルアップキー(11)を受容してこれと係合するダイヤルアップカム(15)であって、用量設定部材を第1の方向へ回転させると、ダイヤルアップカム(15)とダイヤルアップキー(11)とが協働して注入装置のねじりばね(18)に撓みを与える、ダイヤルアップカム、及び
− ダイヤルダウンキー(12)を受容してこれと係合するダイヤルダウンカム(16)であって、用量設定部材を第1の方向とは反対の第2の方向へ回転させると、ダイヤルダウンカム(16)と前記ダイヤルダウンキー(12)とが協働して注入装置のねじりばね(18)を解放する、ダイヤルダウンカム
を備えたダイヤルダウン機構。 - 前記ダイヤルアップカム(15)が、湾曲した軌道の一部を形成する、請求項1に記載のダイヤルダウン機構。
- 湾曲したダイヤルアップカム(15)が、円、楕円又は放物線状の軌道の一部を形成する、請求項2に記載のダイヤルダウン機構。
- 第1及び第2のダイヤルアップカムを備えている、請求項1ないし3のいずれか1項に記載のダイヤルダウン機構。
- 第1及び第2のダイヤルアップキーを備え、第1のダイヤルアップキーが第1のダイヤルアップカムに係合してこれと協働し、第2のダイヤルアップキーが第2のダイヤルアップカムに係合してこれと協働する、請求項4に記載のダイヤルダウン機構。
- ダイヤルダウンカム(16)がV字型軌道の一部を形成する、請求項1ないし5のいずれか1項に記載のダイヤルダウン機構。
- 第1及び第2のダイヤルダウンカムを備えている、請求項1ないし6のいずれか1項に記載のダイヤルダウン機構。
- 第1及び第2のダイヤルダウンキーを備えており、第1のダイヤルダウンキーが第1のダイヤルダウンカムに係合してこれと協働し、第2のダイヤルダウンキーが、第2のダイヤルダウンカムに係合してこれと協働する、請求項7に記載のダイヤルダウン機構。
- ダイヤルアップカム及びダイヤルダウンカムが、同じ軌道の一部を形成する、請求項1ないし8のいずれか1項に記載のダイヤルダウン機構。
- ダイヤルアップキー及びダイヤルダウンキーが同じキーから構成され、前記キーが同じ軌道のダイヤルアップカム及びダイヤルダウンカムに係合してこれと協働する、請求項9に記載のダイヤルダウン機構。
- 請求項1ないし10のいずれか1項に記載のダイヤルダウン機構を備えた薬剤送達装置。
- 手持ち式の薬剤注入ペンである、請求項11に記載の薬剤送達装置。
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US9533106B2 (en) | 2011-12-29 | 2017-01-03 | Novo Nordisk A/S | Torsion-spring based wind-up auto injector pen with dial-up/dial-down mechanism |
CA2874564A1 (en) | 2012-05-31 | 2013-12-05 | Simon Munch Pedersen | Dial-down mechanism for wind-up pen |
-
2005
- 2005-10-20 DE DE602005016952T patent/DE602005016952D1/de active Active
- 2005-10-20 US US11/665,486 patent/US7686786B2/en not_active Ceased
- 2005-10-20 ES ES05807260T patent/ES2334046T3/es active Active
- 2005-10-20 US US14/091,774 patent/USRE46363E1/en active Active
- 2005-10-20 KR KR1020077011425A patent/KR101300496B1/ko active IP Right Grant
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- 2005-10-20 CN CNB200580039614XA patent/CN100571804C/zh active Active
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- 2005-10-20 EP EP05807260A patent/EP1804865B1/en active Active
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- 2005-10-20 AU AU2005298944A patent/AU2005298944B2/en active Active
- 2005-10-20 WO PCT/EP2005/011285 patent/WO2006045526A1/en active Application Filing
- 2005-10-20 PL PL05807260T patent/PL1804865T3/pl unknown
- 2005-10-20 RU RU2007114761/14A patent/RU2389514C2/ru active
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Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
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JP2005514120A (ja) * | 2002-01-10 | 2005-05-19 | オウエン マンフォード リミティド | 医療用注射装置に関する改良 |
JP2005531349A (ja) * | 2002-06-28 | 2005-10-20 | テクファーマ・ライセンシング・アクチェンゲゼルシャフト | 再設定可能な作動閉止部を有する投与装置 |
Also Published As
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AU2005298944A1 (en) | 2006-05-04 |
US20080147005A1 (en) | 2008-06-19 |
DK1804865T3 (da) | 2010-02-01 |
KR101300496B1 (ko) | 2013-09-02 |
CA2584760C (en) | 2013-12-24 |
WO2006045526A1 (en) | 2006-05-04 |
AU2005298944B2 (en) | 2010-12-23 |
RU2389514C2 (ru) | 2010-05-20 |
RU2007114761A (ru) | 2008-11-27 |
ES2334046T3 (es) | 2010-03-04 |
IL182613B (en) | 2019-09-26 |
CN100571804C (zh) | 2009-12-23 |
KR20070084393A (ko) | 2007-08-24 |
IL182613A0 (en) | 2007-07-24 |
DE602005016952D1 (de) | 2009-11-12 |
EP1804865A1 (en) | 2007-07-11 |
JP2008516712A (ja) | 2008-05-22 |
US7686786B2 (en) | 2010-03-30 |
CA2584760A1 (en) | 2006-05-04 |
ATE444090T1 (de) | 2009-10-15 |
ZA200703707B (en) | 2009-02-25 |
EP1804865B1 (en) | 2009-09-30 |
PL1804865T3 (pl) | 2010-03-31 |
CN101060874A (zh) | 2007-10-24 |
USRE46363E1 (en) | 2017-04-11 |
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