JP2012508081A - ワクチンおよびその他の薬剤の自己投与の装置および方法 - Google Patents
ワクチンおよびその他の薬剤の自己投与の装置および方法 Download PDFInfo
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Abstract
Description
[1001]本出願は、「ワクチンおよびその他の薬剤の自己投与の装置および方法」(出願日:2009年11月10日)と題する米国特許出願番号12/615,636の継続出願であり同左に対する優先権と利益を請求し、前記出願は米国仮特許出願番号61/113,368(出願日:2008年11月11日)に対する優先権と利益を請求し、各出願の全てを参照により本明細書に組み込む。米国特許出願番号12/615,636はまた、「薬剤送達のための装置、システムおよび方法」(出願日:2007年1月9日)と題する米国特許出願番号11/621,236の一部継続出願であり同左に対する優先権を主張し、前記特許は「薬剤送達のための装置、システムおよび方法」(出願日:2006年3月29日)と題する米国仮出願番号60/787,046に対する優先権を主張し、前記特許は「薬剤送達のための装置、システムおよび方法」(出願日:2006年3月16日)と題する米国特許出願番号10/572,148の一部継続出願であり同左に対する優先権を主張し、前記特許は「薬剤送達のための装置、システムおよび方法」(出願日:2006年2月1日)と題する国際特許出願番号PCT/US2006/003415の合衆国法典35編371条に基づく国内段階の出願であり、前記特許は「薬剤送達のための装置、システムおよび方法」(出願日:2005年2月1日)と題する米国仮出願番号60/648,822および「フィードバックを備えた自動注射器」(出願日:2005年10月31日)と題する米国仮出願番号60/731,886に対する優先権を主張し、各出願の全てを参照により本明細書に組み込む。
[1008]本発明は一般的には医療装置、より具体的には患者の体内にワクチンおよび/またはその他の薬剤を送達するための医療システム、薬剤送達装置および方法に関連する。
[1012]本明細書は、薬剤送達システムおよび装置について説明している。一部の実施形態において、薬剤送達装置は、筐体、筐体内に配置される薬剤容器、起動メカニズム、カバーおよび電子回路システムを含む。薬剤容器は、例えばワクチンなどの薬剤を含むよう構成される。起動メカニズムは、薬剤を体内に送達するための力を発生させるよう構成されたエネルギー蓄積部材を含む。例えば保護鞘であってもよいカバーは、少なくとも筐体の一部分を受けるよう構成される。電子回路システムは、筐体の一部分がカバーによって受けられるときに、カバーの突起がバッテリーを電子回路システムの一部分から電気的に絶縁するように筐体に結合される。電子回路システムは、筐体の一部分が少なくとも部分的にカバーから取り外されるときに、バッテリーに電気結合されて録音された音声出力を生成させるよう構成される。電子回路システムは、起動メカニズムが作動されたときに、例えば、無線検証信号などの信号を生成するよう構成される。
[1085] 本明細書は、薬剤送達システムおよび装置について説明している。一部の実施形態において、薬剤送達装置は、筐体、筐体内に配置される薬剤容器、起動メカニズム、カバーおよび電子回路システムを含む。薬剤容器は、例えばワクチンなどの薬剤を含むよう構成される。起動メカニズムは、薬剤を体内に送達するための力を発生させるよう構成されたエネルギー蓄積部材を含む。例えば保護鞘であってもよいカバーは、少なくとも筐体の一部分を受けるよう構成される。電子回路システムは、筐体の一部分がカバーによって受けられるときに、カバーの突起がバッテリーを電子回路システムの一部分から電気的に絶縁するように筐体に結合される。電子回路システムは、筐体の一部分が少なくとも部分的にカバーから取り外されるときに、バッテリーに電気結合されて録音された音声出力を生成させるよう構成される。電子回路システムは、起動メカニズムが作動されたときに、例えば、無線検証信号などの信号を生成するよう構成される。
[1239] 前述のように、一部の実施形態において、薬剤送達装置は薬剤送達装置が作動されたときに、電気信号を発生および/または出力するよう構成されてもよい。このようにして、例えば、使用周波数、使用日時および/または薬剤送達装置の使用の成功および/または有効性を測定するパラメータなどの患者のコンプライアンスに関するデータは、薬剤送達装置からの安全性インターロックの取り外しではなく薬剤送達装置の作動に基づいて監視できる。例えば、図61〜63はそれぞれ、第一の構成、第二の構成および第三の構成での、実施形態に従った医療システム3000の略図である。医療システム3000は、薬剤送達装置3002および容器3010を含む。図61に示すように、容器3010は薬剤送達装置3002の少なくとも一部分を受けるよう構成される。例えば、一部の実施形態において、容器3010は、凹部、押さえ、および/または薬剤送達装置3002の少なくとも一部分を嵌合するように受けるその他の適した構造を含みうる。
[1366] 次に、登録情報、治療投薬計画、ワクチン投薬計画、および/または薬剤送達装置に関連する指示は、患者に提供される(19004)。登録情報に関連する指示は、本明細書で表示・記載する種類の指示を提供するよう構成された任意の装置によって提供されてもよい。一部の実施形態において、指示は登録情報(つまり登録装置)を受け取る電子装置によって患者に自動的に提供されてもよい。別の実施形態において、指示は登録装置とは異なる電子装置によって患者に自動的に提供されてもよい。一部の実施形態において、例えば、指示は患者の自宅コンピューターおよび/またはモバイル・コンピューティング装置(例:携帯電話)によって患者に自動的に提供されてもよい。
Claims (16)
- 筐体と、
ワクチンの投与量を含むよう構成された、前記筐体内に配置される薬剤容器と、
前記ワクチンの投与量を体内に送達するための力を発生させるよう構成されたエネルギー蓄積部材を含む起動メカニズムと、
前記筐体に結合される電子回路システムであって、その電子回路システムはワクチンと関連付けられる安定性パラメータを計算するよう構成され、その電子回路システムが作動しているときに安定性パラメータに関連付けられる出力を生成するよう構成された電子回路システムと、を含む装置。 - 前記筐体の少なくとも一部分を受けるよう構成されたカバーであって、そのカバーが、前記筐体の一部分がそのカバーに受容されたときにバッテリーを前記電子回路システムから電気的に絶縁するよう構成された突起を含み、
前記電子回路システムは、前記筐体の一部分が少なくとも部分的に前記カバーから取り外されるときに作動するよう構成された、請求項1に記載の装置。 - 前記安定性パラメータがワクチンの温度履歴に関連付けられる、請求項1に記載の装置。
- ワクチンが乾燥成分と希釈剤を含む請求項1に記載の装置であって、
前記乾燥成分と前記希釈剤を混合するよう構成される混合メカニズムであって、前記安全性パラメータが当該混合メカニズムの作動に関連付けられた混合メカニズムをさらに含む装置。 - 請求項1に記載の装置において、
前記出力が録音された音声出力であり、
前記電子回路システムは、前記起動メカニズムが作動したときに前記安定性パラメータに関連付けられる信号を生成するよう構成されている装置。 - 請求項1に記載の装置において、
前記安定性パラメータの変化に対応して前記起動メカニズムが力を生成するのを防止するよう構成された解除メカニズムをさらに含む装置。 - 筐体と、
薬剤の投与量を含むよう構成された、前記筐体内に配置される薬剤容器と、
前記薬剤を体内に送達するための力を発生させるよう構成されたエネルギー蓄積部材を含む起動メカニズムと、
前記筐体の少なくとも一部分を受けるよう構成されたカバーと、
前記筐体の一部分がカバーによって受容されるときに、前記カバーの突起が電子回路システムからバッテリーを電気的に絶縁するように前記筐体が結合される前記電子回路システムであって、前記筐体の一部分が少なくとも部分的に前記カバーから取り外されるときに前記電子回路システムが前記バッテリーに電気的に結合されて録音された音声出力を生成するよう構成され、前記起動メカニズムが作動したときに前記電子回路システムが信号を生成するよう構成された電子回路システムと、を含む装置。 - 前記薬剤が少なくともインフルエンザA型ワクチン、インフルエンザB型ワクチン、インフルエンザA型(H1N1)ワクチン、A型肝炎ワクチン、B型肝炎ワクチン、ヘモフィルスインフルエンザB型(HiB)ワクチン、麻疹ワクチン、おたふく風邪ワクチン、風疹ワクチン、ポリオワクチン、ヒトパピローマ・ウイルス(HPV)ワクチン、破傷風ワクチン、ジフテリアワクチン、百日咳ワクチン、腺ペストワクチン、黄熱病ワクチン、コレラワクチン、マラリアワクチン、天然痘ワクチン、肺炎球菌ワクチン、ロタウイルスワクチン、水痘ワクチンまたは髄膜炎菌ワクチンの一つである、請求項7に記載の装置。
- 前記録音された音声出力が前記薬剤の安定性に対する指示を含む、請求項7に記載の装置。
- 前記録音された音声出力が、前記薬剤の温度が所定の温度範囲外に逸脱してからの経過時間を示すことを含む、請求項7に記載の装置。
- 請求項7に記載の装置において、
前記電子回路システムが前記薬剤の温度履歴に関連付けられる安定性パラメータを計算するよう構成され、
前記録音された音声出力が前記安定性パラメータに関連付けられている装置。 - 前記録音された音声出力が第一の録音された音声出力であり、前記薬剤が乾燥成分と希釈剤を含む、請求項7に記載において、
前記乾燥成分と前記希釈剤を混合するよう構成された混合メカニズムであって、前記電子回路システムが前記混合メカニズムの作動に関連付けられて第二の録音された音声出力を生成するよう構成された混合メカニズムをさらに含む装置。 - 前記録音された音声出力が、前記薬剤の複数回投与のための投薬計画に関連付けられる第一の指示と、前記起動メカニズムの作動に関連付けられる第二の指示を含む、請求項7に記載の装置。
- 請求項7に記載の装置において、
前記電子回路システムが前記筐体の作動部分が身体と接触して配置されるときにセンサ出力を生成するよう構成されたセンサを含み、
前記電子回路システムがセンサ出力に対応して信号を生成するよう構成された装置。 - 請求項7に記載の装置において、
前記薬剤容器と流体的に連通するよう構成された針であって、その針が前記起動メカニズムによって第一の位置と第二の位置の間で移動するよう構成された針をさらに備え、
前記針の遠位端は、前記針が前記第二の位置にあるときに前記薬剤の投与量を送達するために身体の一部分内に配置されるように構成され、
前記信号が身体の一部分の特性に関連付けられる情報を含む装置。 - 前記エネルギー蓄積部材が非電子エネルギー蓄積部材である、請求項7に記載の装置。
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US12/615,636 | 2009-11-10 | ||
PCT/US2009/063983 WO2010056712A1 (en) | 2008-11-11 | 2009-11-11 | Apparatus and methods for self-administration of vaccines and other medicaments |
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CA2743303A1 (en) | 2010-05-20 |
GB2477483A (en) | 2011-08-03 |
US20100211005A1 (en) | 2010-08-19 |
WO2010056712A1 (en) | 2010-05-20 |
EP2355858A4 (en) | 2015-09-30 |
US9555191B2 (en) | 2017-01-31 |
EP2355858A1 (en) | 2011-08-17 |
US10258735B2 (en) | 2019-04-16 |
US8361026B2 (en) | 2013-01-29 |
US20170049954A1 (en) | 2017-02-23 |
US20160166768A1 (en) | 2016-06-16 |
US20140296824A1 (en) | 2014-10-02 |
GB201109680D0 (en) | 2011-07-27 |
US20190217004A1 (en) | 2019-07-18 |
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