JP7082568B2 - 信号伝達キャップ付き自動注射器 - Google Patents
信号伝達キャップ付き自動注射器 Download PDFInfo
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- JP7082568B2 JP7082568B2 JP2018521111A JP2018521111A JP7082568B2 JP 7082568 B2 JP7082568 B2 JP 7082568B2 JP 2018521111 A JP2018521111 A JP 2018521111A JP 2018521111 A JP2018521111 A JP 2018521111A JP 7082568 B2 JP7082568 B2 JP 7082568B2
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- switch
- cap
- drug delivery
- spring lever
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Description
2015年12月9日に出願された米国仮特許出願第62/265,142号に対する優先権が主張され、その全内容は参照により本明細書に組み込まれる。
(i)米国特許出願公開第2006/0040358号(2006年2月23日公開)、第2005/0008642号(2005年1月13日公開)、第2004/0222859号(2004年11月18日公開)、例えば限定されるものではないが、その中に記載されているものとして抗体1A(DSMZ寄託番号DSM ACC 2586)、抗体8(DSMZ寄託番号DSM ACC 2589)、抗体23(DSMZ寄託番号DSM ACC 2588)、及び抗体18などがある;
(ii)PCT公報WO06/138729(2006年12月28日公開)及びWO05/016970(2005年2月24日公開)、ならびにLu et al.(2004),J.Biol.Chem.279:2856-2865、例えば限定されるものではないが、その中に記載されているものとして抗体2F8、A12及びIMC-A12がある;
(iii)PCT公報WO07/012614(2007年2月1日公開)、WO07/000328(2007年1月4日公開)、WO06/013472(2006年2月9日公開)、WO05/058967(2005年6月30日公開)、及びWO03/059951(2003年7月24日公開);
(iv)米国特許出願公開第2005/0084906(2005年4月21日公開)、例えば限定されるものではないが、その中に記載されているものとして、抗体7C10、キメラ抗体C7C10、抗体h7C10、抗体7H2M、キメラ抗体*7C10、抗体GM607、ヒト化抗体7C10バージョン1、ヒト化抗体7C10バージョン2、ヒト化抗体7C10バージョン3、及び抗体7H2HMがある;
(v)米国特許出願公開第2005/0249728号(2005年11月10日公開)、第2005/0186203号(2005年8月25日公開)、第2004/0265307号(2004年12月30日公開)、及び第2003/0235582号(2003年12月25日公開)、ならびにMaloney et al.(2003),Cancer Res63:5073-5083、例えば限定されるものではないが、その中に記載されている、抗体EM164、リサーフェイスされたEM164、ヒト化EM164、huEM164 v1.0、huEM164 v1.1、huEM164 v1.2、及びhuEM164 v1.3がある;
(vi)米国特許第7,037,498号(2006年5月2日発行)、米国特許出願公開第2005/0244408(2005年11月30日公開)、及び第2004/0086503号(2004年5月6日公開)、ならびにCohen,et al.(2005),Clinical Cancer Res.11:2063-2073、例えば抗体CP-751,871、例えば限定されるものではないがその中に記載されているものとして、ATCCアクセッション番号PTA-2792、PTA-2788、PTA-2790、PTA-2791、PTA-2789、及びPTA-2793を有するハイブリドーマによって産生される抗体、及び抗体2.12.1、2.13.2、2.14.3、3.1.1、4.9.2及び4.17.3の各々がある;
(vii)米国特許出願公開第2005/0136063号(2005年6月23日公開)、及び第2004/0018191号(2004年1月29日公開)、例えば限定されるものではないがその中に記載されているものとして、抗体19D12、及びATCCにPTA-5214という番号で寄託された、プラスミド15H12/19D12 HCA(γ4)のポリヌクレオチドによってコードされる重鎖、及びATCCにPTA-5220という番号で寄託されたプラスミド15H12/19D12 LCF(κ)のポリヌクレオチドによってコードされる軽鎖を含む抗体がある;及び
(viii)米国特許出願公開第2004/0202655号(2004年10月14日公開)、例えば限定されるものではないがその中に記載されているものとして、抗体PINT-6A1、PINT-7A2、PINT-7A4、PINT-7A5、PINT-7A6、PINT-8A1、PINT-9A2、PINT-11A1、PINT-11A2、PINT-11A3、PINT-11A4、PINT-11A5、PINT-11A7、PINT-11A12、PINT-12A1、PINT-12A2、PINT-12A3、PINT-12A4、及びPINT-12A5がある;その各々及び全体は特に、IGF-1受容体を標的とする前述の抗体、ペプチボディ、及び関連タンパク質などに関して、その全体が参照により本明細書に組み込まれる;
Claims (18)
- 薬物送達デバイス(102)であって、
シェルを画定するハウジング(11)と、
前記ハウジング内に少なくとも一部が配置される薬物送達組立体(10)であって、前記ハウジングの内面に係合し、前記ハウジングに対して少なくとも、薬物投与の前の第1の位置、薬物投与中の第2の位置、及び薬物投与後の第3の位置の間で移動可能であるガード(14)を含み、前記第1の位置では、前記ガードの近位端(14a)がカニューレよりも長い長さに延びており、前記第2の位置では、前記ガードが前記カニューレを露出させて前記カニューレが皮膚を貫くようにし、前記第3の位置では、前記ガードは、前記カニューレが露出せず、前記ガードに対して凹んだ状態にある拡張位置にある、前記薬物送達組立体と、
シェルを画定し、前記ハウジングの端部を少なくとも一部覆うように構成されたキャップ(30)と、
前記キャップに少なくとも一部が配置された少なくとも1つの電子構成要素(33)と、
前記少なくとも1つの電子構成要素に選択的に給電するために、前記キャップに少なくとも一部が配置された電源(35)と、
前記キャップに少なくとも一部が配置されたスイッチ組立体(40)と、
を含み、
前記スイッチ組立体は、前記キャップが前記ハウジングから取り外されているときに前記電源に前記少なくとも1つの電子構成要素に給電させ、
前記キャップが前記ハウジングに連結され、前記ガードが前記第1の位置にあるとき、前記電源が前記少なくとも1つの電子構成要素に給電するのを制限し、
前記キャップが前記ハウジングに連結され、前記ガードが前記第3の位置にあるとき、前記電源に前記少なくとも1つの電子構成要素に給電させる
ように構成される、薬物送達デバイス。 - 前記スイッチ組立体がさらに、
前記シェルに少なくとも一部が配置され、作動位置と作動停止位置との間で移動可能なスイッチ(41)であって、前記作動位置にあるときに前記電源に前記少なくとも1つの電子構成要素に給電させるよう構成される、前記スイッチと、
前記シェルに少なくとも一部が配置されるばね式レバー(42)であって、少なくとも一部が少なくとも第1の位置と第2の位置との間で移動可能な、前記ばね式レバーと
を備え、
(a)前記キャップが前記ハウジングに連結され、前記ガードが前記第1の位置にあるとき、前記ハウジングの一部が前記ばね式レバーに接触し、前記ばね式レバーを前記第1の位置に移動させて、前記ばね式レバーが前記スイッチを前記作動停止位置に付勢するようにし、
(b)前記キャップが前記ハウジングに連結され、前記ガードが前記第3の位置を占めるとき、前記ばね式レバーが前記第1の位置の外側にあり、前記スイッチが前記作動位置を占めるようにし、
(c)前記キャップが前記ハウジングから取り外されているとき、前記ばね式レバーが前記薬物送達組立体と接触せず、前記第2の位置を占め、前記スイッチが前記作動位置を占めるようにする、請求項1に記載の薬物送達デバイス。 - 前記キャップが前記ハウジングに連結され、前記ガードが前記第3の位置を占めるとき、前記ばね式レバーは、前記薬物送達組立体と接触しておらず、前記第2の位置を占めて、前記スイッチが前記作動位置を占めるようにする、請求項2に記載の薬物送達デバイス。
- (a)前記ハウジングが、その内面に形成された少なくとも1つの溝(12)を画定し、前記ガードは、前記少なくとも1つの溝と係合するように構成された少なくとも1つの突起を含み、前記ガードの前記第1の位置、前記第2の位置、及び前記第3の位置は、前記少なくとも1つの溝の第1の停止部(12a)、第2の停止部(12b)、及び第3の停止部(12c)に対応する、または
(b)前記ガードが、その外面に形成された少なくとも1つの溝を画定し、前記ハウジングが、前記少なくとも1つの溝に係合するように構成された少なくとも1つの突起を含み、前記ガードの前記第1の位置、前記第2の位置、及び前記第3の位置は、前記少なくとも1つの溝の第1の停止部、第2の停止部、及び第3の停止部に対応する、請求項3に記載の薬物送達デバイス。 - 前記ハウジングまたは前記ガードが前記溝を画定する場合、前記溝が、第1の留め部を画定する第1のセクションと、実質的に軸方向に延びる第2のセクションと、第2の留め部を画定する第3のセクションとを備え、前記第1のセクションの少なくとも一部が、前記第2のセクションに対して傾斜している、請求項4に記載の薬物送達デバイス。
- 前記薬物送達組立体は、前記突起を前記第1の留め部に係合させる力を及ぼすばね(16)をさらに備え、前記ばねに圧縮力を及ぼすと、前記突起は、前記ガードが前記第2の位置に達するまで前記溝を横切るよう構成され、前記ばねへの前記圧縮力を取り除くと、前記突起は、前記溝の前記第2のセクションを横切り、前記第2の留め部に係合するように構成されている、請求項5に記載の薬物送達デバイス。
- 前記キャップに連結された針シールドリムーバ(18)をさらに備え、前記針シールドリムーバが、前記ばね式レバーの弾性部分に付勢力を加えて前記ばね式レバーを前記第2の位置に向けて付勢するように構成されている、請求項2~6のいずれか1項に記載の薬物送達デバイス。
- 前記少なくとも1つの電子構成要素が、前記薬物送達デバイスの状態及び動作状態の少なくとも1つを表すデータを生成するように構成され、前記少なくとも1つの電子構成要素が、前記データを処理ユニットに送信するようにさらに構成される、請求項1~7のいずれか1項に記載の薬物送達デバイス。
- (a)前記ばね式レバーが回転可能であり、第1のセクション(43)と、前記第1のセクションから角度を付けて延び、スイッチ係合領域(45a)を有する第1の長さ部(45)及び前記第1の長さ部と共に実質的にU字形のセクションを形成する第2の長さ部(46)を有する第2のセクション(44)とを含み、前記第2の長さ部は針シールドリムーバからの圧縮力を受け、前記ばね式レバーは、前記第1のセクションが前記ハウジングの前記一部に接触したときの第1の位置と、前記第1のセクションが前記ガードに接触するかもしくは前記薬物送達デバイスの空隙領域内に配置されるときの第2の位置との間で回転する、または、
(b) 前記ばね式レバーが、前記ハウジングから離れるように半径方向に延びる屈曲部(343a)を形成する第1の部分(343)と、スイッチ係合領域(344a)を有する第2の部分(344)とを含み、(i)前記屈曲部が前記薬物送達デバイスの第1の部分によって及ぼされる第1の力を受けるとき、前記スイッチ係合領域が前記スイッチを前記作動停止位置に位置決めし、(ii)前記屈曲部が前記薬物送達デバイスの第2の部分と前記薬物送達デバイスの空隙領域とのうちの1つによって及ぼされる第2の力を受けるとき、前記スイッチ係合領域が前記スイッチを前記作動位置に位置決めする、または、
(c)前記ばね式レバーが、前記キャップの本体から離れるように半径方向に延びる屈曲部(443a)を形成する第1の構成要素(443)と、前記第1の部分に対して傾斜して位置決めされる第2の構成要素(444)とを含み、前記第2の構成要素がスイッチ係合領域(444a)を有し、それにプレテンション力が加えられ、前記第1の位置では、前記第1の構成要素が前記第2の構成要素に接触して、前記スイッチ係合領域を前記スイッチから離れるように付勢して前記スイッチが前記作動停止位置にあるようにし、前記第2の位置では、前記第1の構成要素が前記第2の構成要素に接触せず、それによって前記第2の構成要素がプレテンション状態に移動できるようになり、それによって前記スイッチ係合領域が前記スイッチと係合して前記スイッチを前記作動位置へと付勢する、請求項2に記載の薬物送達デバイス。 - 主要な容器(110)と、前記主要な容器に配置される薬物とをさらに含み、
前記薬物が、
(a)顆粒球コロニー刺激因子(G-CSF)、
(b)ヒトプロタンパク質転換酵素サブチリシン/ケキシン9型(PCSK9)に結合するモノクローナル抗体(IgG)、
(c)カルシトニン遺伝子関連ペプチド(CGRP)に関連する産物、
(d)スクレロスチンを標的とするかまたは調節する産物、
(e)エタネルセプト、
(f)TNF-受容体/Fc融合タンパク質、
(g)TNF遮断薬、または
(h)ブリナツモマブなどの二重特異性T細胞エンゲージャー抗体
の1つを含む、請求項1~9のいずれか一項に記載の薬物送達デバイス。 - 第1の構成要素、第2の構成要素、第3の構成要素、および空隙領域を含む、自動注射器用の信号伝達キャップ(30)であって、
キャップシェル(32)または開口部を画定するキャップ本体と、
前記キャップシェルまたは前記開口部に少なくとも一部が配置される少なくとも1つの電子構成要素(33)と、
前記キャップシェルまたは前記開口部に少なくとも一部が配置される電源(35)と、
前記キャップシェルに少なくとも一部が配置され、作動位置と作動停止位置との間で移動可能なスイッチ(40)であって、前記作動位置にあるときに前記電源に前記少なくとも1つの電子構成要素に給電させるように構成された、前記スイッチと、
前記キャップシェルまたは前記開口部に少なくとも一部が配置されるばね式レバー(42)であって、少なくとも一部が少なくとも第1の位置または第1の構成と第2の位置または第2の構成との間で移動可能な、前記ばね式レバーと
を備え、
(a)前記ばね式レバーが前記第1の位置または前記第1の構成にあるとき、前記ばね式レバーが前記スイッチを前記作動停止位置に付勢し、それによって前記電源が前記少なくとも1つの電子構成要素に給電するのを制限し、
(b)前記ばね式レバーが前記第2の位置または前記第2の構成にあるとき、前記ばね式レバーが前記スイッチを付勢して前記作動位置を占めるようにし、それによって前記電源に前記少なくとも1つの電子構成要素に給電させる、
自動注射器用の信号伝達キャップ。 - 前記ばね式レバーは、回転可能なばね式レバーを備え、
前記回転可能なばね式レバーは、第1のセクション(43)と、前記第1のセクションから角度を付けて延び、スイッチ係合領域(45a)を有する第1の長さ部(45)及び前記第1の長さ部と共に実質的にU字形のセクションを形成する第2の長さ部(46)を有する第2のセクション(44)とを含み、前記第2の長さ部は前記自動注射器の前記第1の構成要素からの圧縮力を受け、
前記回転可能なばね式レバーは、前記第1のセクションが前記自動注射器の前記第2の構成要素に接触したときの前記第1の構成と、前記第1のセクションが前記自動注射器の前記第3の構成要素に接触するかまたは前記自動注射器の前記空隙領域内に配置されるときの前記第2の構成との間で回転し、
(a)前記ばね式レバーが前記第1の構成にあるとき、前記スイッチ係合領域が前記スイッチを前記作動停止位置に位置決めし、前記ばね式レバーの第1のセクションは、薬物投与の前に前記自動注射器の前記第2の構成要素に接触し、
(b)前記ばね式レバーが前記第2の構成にあるとき、前記スイッチ係合領域は前記スイッチを前記作動位置に位置決めし、前記ばね式レバーの第1のセクションは、薬物投与後に前記自動注射器の第3の構成要素に接触するかまたは前記空隙領域内に配置される、
請求項11に記載の信号伝達キャップ。 - 前記第2の長さ部が、針シールドリムーバ(18)から圧縮力を受ける、請求項12に記載の信号伝達キャップ。
- 前記ばね式レバーの前記第1のセクションに及ぼされる屈曲力が、前記ばね式レバーの前記第2の長さ部に及ぼされる前記圧縮力よりも大きいとき、前記ばね式レバーが前記第1の構成に維持される、および/または、
前記ばね式レバーの前記第1のセクションに及ぼされる屈曲力が、前記ばね式レバーの前記第2の長さ部に及ぼされる前記圧縮力よりも小さいとき、前記ばね式レバーが前記第2の構成に維持される、請求項12または13に記載の信号伝達キャップ。 - 前記ばね式レバーが、前記ばね式レバーを前記信号伝達キャップに回転可能に固定する回転式連結部(47)をさらに備える、および/または、
前記スイッチが、前記ばね式レバーから係合解除されたときに前記作動停止位置に付勢されるように構成される、請求項12~14のいずれか1項に記載の信号伝達キャップ。 - 前記ばね式レバーは、前記キャップ本体から離れるように半径方向に延びる屈曲部(343a)を形成する第1の部分(343)と、スイッチ係合領域(344a)を有する第2の部分(344)とを含み、
(a)前記屈曲部が前記自動注射器の前記第1の部分によって及ぼされる第1の力を受けるとき、前記スイッチ係合領域が前記スイッチを前記作動停止位置に位置決めし、
(b)前記屈曲部が前記自動注射器の前記第2の部分と前記自動注射器の前記空隙領域とのうちの1つによって及ぼされる第2の力を受けるとき、前記スイッチ係合領域が前記スイッチを前記作動位置に位置決めする、
請求項11に記載の信号伝達キャップ。 - 前記第1の力が前記第2の力より大きい、および/または、
前記第2の力がゼロに等しい、および/または、
前記第1及び前記第2の力が、前記キャップシェルの壁に向かって作用する半径方向の力を含む、および/または、
前記ばね式レバーが、前記第1の部分に連結された第3の部分をさらに備え、前記第3の部分は、前記ばね式レバーを前記信号伝達キャップの一部に固定するように構成される、請求項16に記載の信号伝達キャップ。 - 前記ばね式レバーは、前記キャップ本体から離れるように半径方向に延びる屈曲部(443a)を形成する第1の構成要素(443)と、前記第1の構成要素に対して傾斜して位置決めされる第2の構成要素(444)とを含み、
前記第2の構成要素がスイッチ係合領域(444a)を有し、それにプレテンション力が加えられ、
前記第1の構成では、前記第1の構成要素が前記第2の構成要素に接触して、前記スイッチ係合領域を前記スイッチから離れるように付勢して前記スイッチが前記作動停止位置にあるようにし、前記第2の構成では、前記第1の構成要素が前記第2の構成要素に接触せず、それによって前記第2の構成要素がプレテンション状態に移動できるようになり、それによって前記スイッチ係合領域が前記スイッチと係合して前記スイッチを前記作動位置へと付勢する、請求項11に記載の信号伝達キャップ。
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