JP7247174B2 - 薬物送達デバイスのプランジャ - Google Patents
薬物送達デバイスのプランジャ Download PDFInfo
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- JP7247174B2 JP7247174B2 JP2020517300A JP2020517300A JP7247174B2 JP 7247174 B2 JP7247174 B2 JP 7247174B2 JP 2020517300 A JP2020517300 A JP 2020517300A JP 2020517300 A JP2020517300 A JP 2020517300A JP 7247174 B2 JP7247174 B2 JP 7247174B2
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Description
2017年11月10日に出願された米国仮特許出願第62/584,335号明細書の優先権の利益を主張し、その内容全体が、参照により本明細書に明示的に援用される。
プランジャ実施形態の更なる詳細を提供する前に、図1を参照し、高粘性製品の送達に適した例示的な薬物送達デバイスを説明する。第1の例では、オートインジェクタ100は、シリンジアセンブリ110と作動機構150とを有するハウジング102を含む。シリンジアセンブリ110及び作動機構150の少なくとも一部分はハウジング102内に配置されている。シリンジアセンブリ110は、シリンジバレル112と、針アセンブリ114と、針アセンブリ114に隣接して配置された任意のフィルタ部材120とを含む。作動機構150は、フレーム部材152と、以下で更に詳細に説明するプランジャ200を含むプランジャアセンブリ160と、プランジャロッドガイド170と、渦巻ばね(例えば、時計のゼンマイ)180と、を含む。
高粘性製品を送達するために薬物送達デバイスにおいて使用するのに好適な例示的なプランジャ200を図2及び図3に示す。各プランジャ200は本体部分202を含み、本体部分202は、長手方向軸線Lに沿って延びる略円筒状の側壁203を有し、それぞれその先頭端部208及び後尾端部210に先頭面204及び後尾面206を有する。プランジャ200はその後尾面206上で係合され、図1を参照して説明したようにシリンジバレル112内を押し進められ、それによりシリンジバレル112から薬剤113を排出するように構成されている。好適な実施形態では、本明細書中に記載される本体部分202はプランジャロッドを受け入れるなどのための空洞を有しない。このように構成されることで、各本体部分202の断面は、その先頭面204と後尾面206との間のその軸方向長さに沿って途切れのない構成を有する。
図2及び図24に示すプランジャ200を、図1を参照して上述したオートインジェクタ薬物送達デバイス100での使用を参照して説明してきたが、本明細書中に記載されるプランジャ200は更に、オンボディ型インジェクタデバイスなどの他の薬物送達デバイスでの使用に好適である。図39は、本開示の原理に従って作製されたオンボディ型薬物送達デバイス10の一実施形態の概略図である。薬物送達デバイス10は、患者に薬物を皮下的に又は経皮的に送達するように動作させてもよい。図示される実施形態においては、薬物送達デバイス10は、オンボディ型インジェクタ又は携帯型輸液ポンプなどのウェアラブル薬物送達デバイスとして構成され、患者の組織11(例えば、患者の皮膚)に取り外し可能に取り付けられる。他の実施形態(図示せず)では、薬物送達デバイス10は、注射の過程にわたり患者の組織11に一時的に押し付けられる、オートインジェクタ又は注射ペンなどのペン型インジェクタとして構成されていてもよい。薬物送達デバイス10は、一定の又は患者/オペレータが設定可能な用量の薬物を制御された又は選択された時間にわたって自動的に送達するように構成されていてもよい。更に、薬物送達デバイス10は患者による自己投与用であってもよい、又は注入を管理するように正式に訓練された医療関係者若しくは他の介護者によって操作されてもよい。
上記の説明は、薬剤送達デバイスと共に使用するための様々なアセンブリ、デバイス、及び方法を述べている。システム、薬剤送達デバイス、又は方法は、後述の薬剤の使用を更に含むことができる点を明確にすべきであるが、以下のリストは網羅的でも限定的でもないと考えるべきではないことに留意されたい。薬剤は、チャンバ又はリザーバ内に収容される。いくつかの場合では、リザーバは、治療のために薬剤が充填される若しくは予め充填される、のいずれかである一次容器である。一次容器は、カートリッド又はプレフィルドシリンジとすることができる。
(i)米国特許出願公開第2006/0040358号明細書(2006年2月23日公開)、同第2005/0008642号明細書(2005年1月13日公開)、同第2004/0228859号明細書(2004年11月18日公開)で、その中に記載されている抗体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が含まれるが、これらに限定されない。
(ii)PCT国際公開第06/138729号パンフレット(2006年12月28日公開)及びPCT国際公開第05/016970号パンフレット(2005年2月24日公開)、及びLu et al.(2004),J.Biol.Chem.279:2856-2865に記載されている抗体2F8、A12、及びIMC-A12を含むがこれらに限定されない、
(iii)PCT出願公開番号国際公開第07/012614号パンフレット(2007年2月1日公開)、同第07/000328号パンフレット(2007年1月4日公開)、同第06/013472号パンフレット(2006年2月9日公開)、同第05/058967号パンフレット(2005年6月30日公開)、及び同第03/059951号パンフレット(2003年7月24日公開)。
(iv)米国特許出願公開第2005/0084906号明細書(2005年4月21日公開)に記載される抗体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を含むが、これらに限定されない。
(v)米国特許出願公開第2005/0249728号明細書(2005年11月10日公開)、米国特許出願公開第2005/0186203号明細書(2005年8月25日公開)、米国特許出願公開第2004/0265307号明細書(2004年12月30日公開)、及び米国特許出願公開第2003/0235582号明細書(2003年12月25日公開)、並びにMaloney et al.(2003),Cancer Res.63:5073-5083に記載されている抗体EM164、再表面形成(resurfaced)EM164、ヒト化EM164、huEM164 v1.0、huEM164 v1.1、huEM164 v1.2、及びhuEM164 v1.3を含むがこれらに限定されない、
(vi)米国特許第7,037,498号明細書(2006年5月2日発行)、米国特許出願公開第2005/0244408号明細書(2005年11月30日公開)及び米国特許出願公開第2004/0086503号(2004年5月6日公開)、並びにCohen,et al.(2005),Clinical Cancer Res.11:2063-2073に記載されている、ATCC受託番号PTA-2792、PTA-2788、PTA-2790、PTA-2791、PTA-2789、PTA-2793、及び抗体2.12.1、2.13.2、2.14.3、3.1.1、4.9.2、及び4.17.3を有するハイブリドーマによって産生された抗体の各々を含むがこれらに限定されない、例えば、抗体CP-751,871、
(vii)米国特許出願公開第2005/0136063号明細書(2005年6月23日公開)及び米国特許出願公開第2004/0018191号明細書(2004年1月29日公開)に記載されている抗体19D12と、ATCCに受託番号PTA-5214で受託されているプラスミド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に受託番号PTA-5220で受託されているプラスミド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と、を含むがこれらに限定されない、並びに
(viii)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等に関して参照により各々の全体が本明細書に組み込まれる米国特許出願公開第2004/0202655号明細書(2004年10月14日公開)に記載されている抗体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を含むがこれらに限定されない、
Claims (20)
- 薬物送達デバイスで使用するためのプランジャであって、
略円筒状の側壁と、先頭面と、後尾面と、を有し、空洞を含まない本体部分と、
前記本体部分の前記側壁から径方向外側に突出し、凹設された側表面によって互いに軸方向に離隔した複数のリブであって、前記複数のリブは、少なくとも、後尾リブと、先頭リブと、中間リブと、を含み、前記リブのそれぞれは環状構成を含む、複数のリブと、
を含み、
前記本体部分は、軸荷重の非存在下で第1の形態、軸荷重の存在下で第2の形態をとるように構成されており、前記第1の形態と前記第2の形態は等しい径方向寸法を有し、前記第2の形態は、前記第1の形態の軸方向寸法よりも小さい軸方向寸法を有する、
プランジャ。 - 前記リブ間に延びる前記側壁の側表面は曲線状の構成を有する、請求項1に記載のプランジャ。
- 前記リブ間に延びる前記側壁の前記側表面は凹面である、請求項2に記載のプランジャ。
- 前記リブ間に延びる前記本体部分の側表面は平坦部分を含む、請求項1に記載のプランジャ。
- 前記リブ間に延びる前記本体部分の前記側表面は、前記平坦部分の軸方向端部に円錐台部分を更に含む、請求項4に記載のプランジャ。
- 前記本体部分のトリムエッジは前記本体部分の前記後尾面に隣接する、請求項1~5のいずれか一項に記載のプランジャ。
- 前記トリムエッジは前記リブの外径よりも小さな外径を有する、請求項6に記載のプランジャ。
- 前記先頭面は粗面加工部を含む、請求項1~7のいずれか一項に記載のプランジャ。
- 略円錐形の構成としての前記先頭面である、請求項1~8のいずれか一項に記載のプランジャ。
- 前記後尾リブ又は前記中間リブのうちの少なくとも1つは前記先頭リブよりも軸方向に小さい、請求項1~9のいずれか一項に記載のプランジャ。
- 前記後尾リブ及び前記中間リブの両方が前記先頭リブよりも軸方向に小さい、請求項10に記載のプランジャ。
- 前記リブのうちの少なくとも1つは曲線状の軸方向プロファイルを有する、請求項1~11のいずれか一項に記載のプランジャ。
- 前記リブのうちの少なくとも1つは、前記リブのうちの少なくとも1つの曲線状の軸方向端部部分間に延びる円筒状部分を含む、請求項1~12のいずれか一項に記載のプランジャ。
- 前記本体部分の前記後尾面から離れる方に延びる複数の突起を更に含む、請求項1~13のいずれか一項に記載のプランジャ。
- 薬物送達アセンブリであって、
プランジャであって、
略円筒状の側壁と、先頭面と、後尾面と、を有し、空洞を含まない本体部分と、
前記本体部分の前記側壁から径方向外側に突出し、凹設された側表面によって互いに軸方向に離隔した複数のリブであって、前記複数のリブは、少なくとも、後尾リブと、先頭リブと、中間リブと、を含み、前記リブのそれぞれは環状構成を含む、複数のリブと、
を含み、
前記本体部分は、軸荷重の非存在下で第1の形態、軸荷重の存在下で第2の形態をとるように構成されており、前記第1の形態と前記第2の形態は等しい径方向寸法を有し、前記第2の形態は、前記第1の形態の軸方向寸法よりも小さい軸方向寸法を有する、
プランジャと、
第1開端部と投与開口部を有する第2端部との間に延びる環状側壁を有するチャンバであって、前記プランジャは、前記プランジャの前記リブが前記側壁の内部表面を密閉するように前記チャンバ内に受け入れられる、チャンバと、
前記チャンバ内で前記プランジャを前記チャンバの前記第2端部まで駆動するように構成された駆動部材と、
を含む、薬物送達アセンブリ。 - 前記側壁内側上の前記リブの接触領域は、前記プランジャが前記チャンバ内で駆動される間、一定のままである、請求項15に記載の薬物送達アセンブリ。
- 前記プランジャのトリムエッジは、前記プランジャが前記チャンバ内で駆動される間、前記側壁内側から離隔している、請求項15又は16に記載の薬物送達アセンブリ。
- 前記リブは、空輸中の前記チャンバ内のプランジャ移動距離の少なくとも2倍、互いに軸方向に離間している、請求項15~17のいずれか一項に記載の薬物送達アセンブリ。
- オートインジェクタデバイスであって、
ハウジングと、
前記ハウジング内に少なくとも部分的に受け入れられ、第1開端部と投与開口部を有する第2端部との間に延びる環状側壁を有するシリンジバレルと、針アセンブリと、を含む、シリンジアセンブリと、
前記ハウジング内に少なくとも部分的に受け入れられた作動機構であって、
前記シリンジバレル内に受け入れられたプランジャであって、
略円筒状の側壁と、先頭面と、後尾面と、を有し、空洞を含まない本体部分と、
前記本体部分の前記側壁から径方向外側に突出し、凹設された側表面によって互いに軸方向に離隔した複数のリブであって、前記複数のリブは、少なくとも、後尾リブと、先頭リブと、中間リブと、を含み、前記リブのそれぞれは環状構成を含み、前記リブが前記シリンジバレルの前記側壁の内部表面を密閉するような大きさに作られる、複数のリブと、
を含み、
前記本体部分は、軸荷重の非存在下で第1の形態、軸荷重の存在下で第2の形態をとるように構成されており、前記第1の形態と前記第2の形態は等しい径方向寸法を有し、前記第2の形態は、前記第1の形態の軸方向寸法よりも小さい軸方向寸法を有する、
プランジャを含む、作動機構と、
駆動機構と、
前記駆動機構によって駆動され、前記シリンジバレル内で前記プランジャを前記シリンジバレルの前記第2端部まで押し、それにより、前記シリンジバレル内の薬剤を、前記針アセンブリを通して押し出すように構成された駆動部材と、
を含む、オートインジェクタデバイス。 - オンボディ型インジェクタデバイスであって、
ハウジングであって、前記ハウジング内に延びる開口部内に内部及び底壁を有し、使用者の組織に固定されるように構成されている、ハウジングと、
第1開端部と投与開口部を有する第2端部との間に延びる環状側壁を有するリザーバと、
駆動機構であって、
前記リザーバ内に受け入れられたプランジャであって、
略円筒状の側壁と、先頭面と、後尾面と、を有し、空洞を含まない本体部分と、
前記本体部分の前記側壁から径方向外側に突出し、凹設された側表面によって互いに軸方向に離隔した複数のリブであって、前記複数のリブは、少なくとも、後尾リブと、先頭リブと、中間リブと、を含み、前記リブのそれぞれは環状構成を含み、前記リブが前記リザーバの前記側壁の内部表面を密閉するような大きさに作られている、複数のリブと、
を含み、
前記本体部分は、軸荷重の非存在下で第1の形態、軸荷重の存在下で第2の形態をとるように構成されており、前記第1の形態と前記第2の形態は等しい径方向寸法を有し、前記第2の形態は、前記第1の形態の軸方向寸法よりも小さい軸方向寸法を有する、プランジャを含む、駆動機構と、
前記リザーバ内で前記プランジャを前記リザーバの前記第2端部まで駆動するように構成された駆動部材と、
前記ハウジングの前記開口部を通って前記ハウジング内の後退位置から前記ハウジングの外に延びる展開位置に移動するように構成された送達部材を含む挿入機構と、
前記リザーバを前記挿入機構に流体的に結合するように構成された流体経路アセンブリと、
アクチュエータであって、前記アクチュエータの作動に応答し、前記駆動機構に、前記リザーバ内で前記プランジャを前記リザーバの前記第2端部まで駆動させ、それにより、前記挿入機構を通して前記リザーバ内の薬剤を投与するように構成されたアクチュエータと、
を含む、オンボディ型インジェクタデバイス。
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WO2019094138A1 (en) | 2019-05-16 |
MA50557A (fr) | 2020-09-16 |
MX2020004736A (es) | 2020-08-13 |
EP3706826A1 (en) | 2020-09-16 |
IL273637A (en) | 2020-05-31 |
CN111225696B (zh) | 2023-07-18 |
CA3079665A1 (en) | 2019-05-16 |
AU2018364933A1 (en) | 2020-04-09 |
AU2018364933B2 (en) | 2024-01-25 |
US20220047815A1 (en) | 2022-02-17 |
SG11202002966QA (en) | 2020-05-28 |
US11191904B2 (en) | 2021-12-07 |
CN116832271A (zh) | 2023-10-03 |
US20190143047A1 (en) | 2019-05-16 |
JP2023075267A (ja) | 2023-05-30 |
AU2024202623A1 (en) | 2024-05-09 |
JP2021502132A (ja) | 2021-01-28 |
CN111225696A (zh) | 2020-06-02 |
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