JP2022088452A - 針ガードの移動に対する抵抗力の閾値が調整可能な針ガード機構を備えた薬物送達装置 - Google Patents
針ガードの移動に対する抵抗力の閾値が調整可能な針ガード機構を備えた薬物送達装置 Download PDFInfo
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Abstract
Description
2015年2月27日に出願された米国仮特許出願第62/121,758号に対して優先権を主張する。本仮特許出願の全ての内容は、参照によって本明細書に組み込まれる。
本開示は、薬物送達装置に関する。より具体的には、本開示は、針挿入の効果を発揮させるために患者または操作者が打ち勝つ必要のある針ガードの移動に対する抵抗力の閾値が調整可能である干渉機構を有する針ガード機構を備えた薬物送達装置に関する。
本明細書において開示されるのは薬物送達装置である。各種実施形態において、薬物送達装置は、投与量送達部材を含む薬物貯蔵容器を搭載するように構成され、開口を備えた筐体であって、投与量送達部材の少なくとも挿入部分が筐体の前記開口を通って延在すべく構成されるようになっている、筐体と;開口に近接して配置され、かつ伸長位置と格納位置の間で筐体に対して移動可能な針ガードであって、投与量送達部材の挿入部分は、伸長位置にある針ガードによって取り囲まれており、投与量送達部材の挿入部分は、針ガードが格納位置にあるときに少なくとも部分的に露出されている、針ガードと;投与量送達部材を注射部位の身体組織に挿入している間、伸長位置から格納位置までの針ガードの移動に対する選択された閾値の抵抗力を与えるための干渉機構であって、干渉機構は、筐体の表面に付随した第1の部材と針ガードから延在する第2の部材とを備え、第1の部材と第2の部材は、互いに係合して針ガードを伸長位置に保持し、第1の部材と第2の部材の一方は、投与量送達部材の挿入中に薬物送達装置が注射部位の方に押圧されると、選択された閾値の抵抗力を超えた場合に移動して、第1の部材と第2の部材を互いに通り越して摺動させ、針ガードを格納位置に移動させる、干渉機構とを備える。
図2Aは、本開示に係る携帯型薬物送達装置100の実施形態を示す。この装置は、針ガード152の移動に対する抵抗力の閾値を調整可能な針ガード機構150を備えており、針挿入、速度及び力の効果を発揮させ、最適化を行うようになっている。薬物送達装置100は、単回使用の使い捨て注射器として、または複数回使用の再利用可能な注射器として構成することができる。薬物送達装置100は、例えば、約1~200センチポアズの範囲をとることが可能な粘度を有するものを含む、任意の適切な医薬品または薬物を送達するように構成することができる。更に、薬物送達装置100は、自己投与するための自動注射器として構成することができるが、かかる装置を介護者または正式に訓練された医療提供者によって使用して注射することもできる。図2Aを参照すると、各種実施形態の薬物送達装置100は、薬物貯蔵装置120を保持する長尺のハウジングまたは外部筐体110を更に備えることができる。各種実施形態の薬物貯蔵装置120は、主容器122、内部に含まれる医薬品または薬物128を放出するために主容器122の内部チャンバ122cに移動可能に配置されたストッパ126、及び注射針124(図示)、カニューレまたは身体組織に侵入し、患者の身体に薬物を投与することが可能なその他の適切な投与量送達部材もしくは要素を備えることができる。いくつかの実施形態において、薬物貯蔵装置120は、従来のガラスまたはプラスチック製のシリンジまたはカートリッジを備えてもよい。着脱可能なシールド129を注射針124を覆って取り付けて、薬物送達装置100を使用する前に当該注射針を無菌の状態に維持することができる。薬物貯蔵装置120は、1回以上の投与量の医薬品または薬物128で予備充填されてもよい。
(i)米国公報第2006/0040358号(2006年2月23日公開)、米国公報第2005/0008642号(2005年1月13日公開)、米国公報第2004/0228859号(2004年11月18日公開)。これらの公報に記載されているように、例えば、抗体1A(DSMZ寄託番号DSMACC2586)、抗体8(DSMZ寄託番号DSMACC2589)、抗体23(DSMZ寄託番号DSMACC2588)及び抗体18を非限定的に含む;
(ii)PCT公報第06/138729号(2006年12月28日公開)、PCT公報第05/0169709号(2005年2月24日公開)、ならびにLu et al.(2004),J.Biol.Chem.279:2856-2865。これらの文献に記載されているように、抗体2F8、A12及びIMC-A12を非限定的に含む;
(iii)PCT公報第07/012614号(2007年2月1日公開)、PCT公報第07/000328号(2007年1月4日公開)、PCT公報第06/013472号(2006年2月9日公開)、PCT公報第05/058967号(2005年6月30日公開)及びPCT公報第03/059951号(2003年7月24日公開);
(iv)米国公報第2005/0084906号(2005年4月21日公開)。この公報に記載されているように、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を非限定的に含む;
(v)米国公報第2005/0249728号(2005年11月10日公開)、米国公報第2005/0186203号(2005年8月25日公開)、米国公報第2004/0265307号(2004年12月30日公開)及び米国公報第2003/0235582号(2003年12月25日公開)、ならびにMaloney et al.(2003),Cancer Res.63:5073-5083。これらの文献に記載されているように、抗体EM164、表面が再構成されたEM164、ヒト化EM164、huEM164 v1.0、huEM164 v1.1、huEM164 v1.2及び、huEM164 v1.3を非限定的に含む;
(vi)米国特許第7037498号(2006年5月2日発行)、米国公報第2005/0244408号(2005年11月30日公開)及び米国公報第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。これらの文献に記載されているように、ATCC受け入れ番号PTA-2792、PTA-2788、PTA-2790、PTA-2791、PTA-2789、PTA-2793を有するハイブリドーマによって生成された抗体、ならびに抗体2.12.1、2.13.2、2.14.3、3.1.1、4.9.2及び4.17.3、のそれぞれを非限定的に含む;
(vii)米国公報第2005/0136063号(2005年6月23日公開)及び米国公報第2004/0018191号(2004年1月29日公開)。これらの公報に記載されているように、抗体19D12、ならびにATCCの下の番号PTA-5214で寄託されたプラスミド15H12/19D12HCA(γ4)におけるポリヌクレオチドによってコード化された重鎖及びATCCの下の番号PTA-5220で寄託されたプラスミド15H12/19D12LCF(κ)におけるポリヌクレオチドによってコード化された軽鎖を含む抗体を非限定的に含む;
(viii)米国公報第2004/0202655号(2004年10月14日公開)。この公報に記載されているように、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を非限定的に含み、これらのそれぞれ及び全ては、特にIGF-1受容体を標的とする上記抗体、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って本明細書に組み込まれる;
Claims (15)
- 薬物送達装置であって、
投与量送達部材を含む薬物貯蔵容器を搭載するように構成され、開口を備えた筐体であって、前記投与量送達部材の少なくとも挿入部分が前記筐体の前記開口を通って延在すべく構成されるようになっている、前記筐体と、
前記開口に近接して配置され、かつ伸長位置と格納位置の間で前記筐体に対して移動可能な針ガードであって、前記投与量送達部材の前記挿入部分は、前記伸長位置にある前記針ガードによって取り囲まれており、前記投与量送達部材の前記挿入部分は、前記針ガードが前記格納位置にあるときに少なくとも部分的に露出されている、前記針ガードと、
前記投与量送達部材を注射部位の身体組織に挿入している間、前記伸長位置から前記格納位置までの前記針ガードの移動に対する選択された閾値の抵抗力を与えるための干渉機構であって、前記干渉機構は、前記筐体の内面に付随した第1の部材と前記針ガードから延在する第2の部材とを備え、前記第1の部材と前記第2の部材は、互いに係合して前記針ガードを前記伸長位置に保持し、前記第1の部材と前記第2の部材の一方は、前記投与量送達部材の挿入中に前記薬物送達装置が前記注射部位の方に押圧されると、前記選択された閾値の抵抗力を超えた場合に移動して、前記第1の部材および前記第2の部材は摺動しながら互いを乗り越え、前記針ガードを前記格納位置に移動させる、前記干渉機構と
を備える、前記薬物送達装置。 - 前記第1の部材と前記第2の部材の一方はカムを備え、前記第1の部材と前記第2の部材の他の一方はカム従動子を備える、請求項1に記載の薬物送達装置。
- 前記カム従動子は前記カムに対して付勢されている、請求項2に記載の薬物送達装置。
- 前記カム従動子は、前記カムに対向する前記カム従動子に付勢力を印加する可撓性アームを備える、請求項2から請求項3のいずれか1項に記載の薬物送達装置。
- 前記カム従動子は、前記可撓性アームの自由端に、または前記自由端に近接して配置された突起を更に備える、請求項4に記載の薬物送達装置。
- 前記カム従動子は、前記可撓性アームの自由端に、または前記自由端に近接して配置された溝を更に備える、請求項4に記載の薬物送達装置。
- 前記カムは、固定された連続型または分割型の円周ビードを備える、請求項2から請求項6のいずれか1項に記載の薬物送達装置。
- 前記カムは、固定された溝を備える、請求項2から請求項5のいずれか1項に記載の薬物送達装置。
- 前記針ガードは、前記格納位置において前記筐体に少なくとも部分的に入り込んでいる、請求項1から請求項8のいずれか1項に記載の薬物送達装置。
- 前記第1の部材は前記カム部材を備え、前記第2の部材は前記カム従動子部材を備える、請求項2から請求項9のいずれか1項に記載の薬物送達装置。
- 前記第1の部材は前記カム従動子部材を備え、前記第2の部材は前記カム部材を備える、請求項2から請求項9のいずれか1項に記載の薬物送達装置。
- 前記薬物貯蔵容器はシリンジを備える、請求項1から請求項11のいずれか1項に記載の薬物送達装置。
- 薬物を放出するために前記薬物貯蔵容器内に移動可能に配置されたストッパを前記薬物貯蔵容器が更に備え、前記ストッパに作用するプランジャと、前記プランジャに力を及ぼして前記プランジャを前記ストッパに作用させて前記薬物を放出させるためのエネルギー源とを含む注射駆動機構を更に備える、請求項1から請求項12のいずれか1項に記載の薬物送達装置。
- 前記投与量送達部材は注射針またはカニューレを備える、請求項1から請求項13のいずれか1項に記載の薬物送達装置。
- 前記薬物貯蔵容器に貯蔵された薬物を更に備え、前記薬物は、TNF阻害剤、カルシトニン遺伝子関連ペプチド受容体に対する抗体、コロニー刺激因子、赤血球生成刺激剤、アペリン受容体アゴニスト、抗胸腺間質性リンパ球新生因子抗体、抗胸腺間質性リンパ球新生因子受容体抗体、ヒトタンパク質転換酵素サブチリシン/ケキシン9型と結合する抗体、及びメタロプロテイアーゼの組織阻害剤からなる群から選択される、請求項1から請求項14のいずれか1項に記載の薬物送達装置。
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US11872374B2 (en) | 2024-01-16 |
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WO2016138434A1 (en) | 2016-09-01 |
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US11806509B2 (en) | 2023-11-07 |
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