JP6126783B2 - 被検体の皮膚から、および/または該皮膚の下から引き抜かれた媒体の分析用のデバイス - Google Patents
被検体の皮膚から、および/または該皮膚の下から引き抜かれた媒体の分析用のデバイス Download PDFInfo
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- JP6126783B2 JP6126783B2 JP2011552935A JP2011552935A JP6126783B2 JP 6126783 B2 JP6126783 B2 JP 6126783B2 JP 2011552935 A JP2011552935 A JP 2011552935A JP 2011552935 A JP2011552935 A JP 2011552935A JP 6126783 B2 JP6126783 B2 JP 6126783B2
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Description
本願は、Levinsonらによる米国仮特許出願第61/163,710号(名称「Systems and Methods for Creating and Using Suction Blisters or Other Pooled Regions of Fluid within the Skin」、2009年3月26日出願)、Levinsonらによる米国仮特許出願第61/156,632号(名称「Oxygen Sensor」、2009年3月2日出願)、Levinsonらによる米国仮特許出願第61/269,436号(名称「Devices and Techniques associated with Diagnostics,Therapies, and Other Applications, Including Skin−Associated Applications」、2009年6月24日出願)、Bernsteinらによる米国仮特許出願第61/257,731号(名称「Devices and Techniques associated with Diagnostics,Therapies,and Other Applications,Including Skin−Associated Applications」、2009年11月3日出願)、およびLevinsonらによる米国仮特許出願第61/294,543号(名称「Blood Sampling Device and Method」、2010年1月13日出願)の利益を主張する。上記出願の各々は、本明細書に参考として援用される。
本発明は、概して、被検体の状態を分析するか、または被検体を治療する際に使用するための間質液および他の体液に関する。本発明はまた、例えば、皮膚を通して、流体を送達するため、および/または被検体から引き抜くためのシステムおよび方法に関する。
本発明は、例えば、以下を提供する。
(項目1)
被検体からの抽出可能媒体の分析用のデバイスであって、該デバイスは、
該被検体の皮膚に近接して設置されるように構築および配設される支持構造と、
アクセス部位における該被検体の該皮膚から、および/または該皮膚を通して該抽出可能媒体にアクセスする、該支持構造と関連付けられる手段と、
該アクセス部位の少なくとも一部分における該皮膚をわたる圧力差を生成することが可能である、該支持構造によって支持される圧力調節器と、
該被検体からの該抽出可能媒体の少なくとも1つの状態を決定する、該支持構造によって支持されるセンサと、
該センサによって決定される該媒体の該状態に関する信号を発生させる、該支持構造によって支持される信号発生器と
を備える、デバイス。
(項目2)
上記皮膚への上記支持構造の接着のための接着剤を含む、項目1に記載のデバイス。
(項目3)
上記抽出可能媒体にアクセスする手段を起動し、それにより、上記被検体の皮膚から、または皮膚を通して該媒体を抽出する、上記支持構造と関連付けられる抽出起動部をさらに備える、項目1または2のうちのいずれか一項に記載のデバイス。
(項目4)
上記抽出起動部は、上記皮膚に対して配置可能である、項目3に記載のデバイス。
(項目5)
上記抽出起動部は、上記デバイスが上記皮膚に対して配置されると生成される力を決定することが可能である、項目3または4のうちのいずれか一項に記載のデバイス。
(項目6)
上記支持構造は、上記デバイスを上記皮膚に貼付するための機械的要素をさらに備える、項目1〜5のうちのいずれか一項に記載のデバイス。
(項目7)
上記支持構造は、上記抽出可能媒体にアクセスする上記手段を含有する陥凹を含有する、項目1〜6のうちのいずれか一項に記載のデバイス。
(項目8)
上記支持構造は、上記抽出起動部と流体的に連絡している微小流体チャネルをさらに備える、項目1〜7のうちのいずれか一項に記載のデバイス。
(項目9)
上記デバイスは、上記被検体から流体を引き抜くことが可能である、項目1〜8のうちのいずれか一項に記載のデバイス。
(項目10)
上記流体は、血液を含む、項目9に記載のデバイス。
(項目11)
上記流体は、間質液を含む、項目9または10に記載のデバイス。
(項目12)
上記デバイスは、上記抽出可能媒体にアクセスする上記手段と流体的に連絡している貯蔵区画をさらに備える、項目9〜11のうちのいずれか一項に記載のデバイス。
(項目13)
上記デバイスは、上記被検体から引き抜かれた流体内に含有される被分析物を決定することが可能である、項目1〜12のうちのいずれか一項に記載のデバイス。
(項目14)
上記デバイスは、後に上記被検体の皮膚から該デバイスを除去することなく、上記被分析物を決定することが可能である、項目13に記載のデバイス。
(項目15)
上記デバイスは、自動的に上記被分析物を決定することが可能である、項目13および14のうちのいずれか一項に記載のデバイス。
(項目16)
上記デバイスは、上記被分析物の上記決定の結果を表示することが可能である、項目13〜15のうちのいずれか一項に記載のデバイス。
(項目17)
上記デバイスは、上記抽出可能媒体にアクセスする上記手段を介して、流体を上記被検体に送達することが可能である、項目1〜16のうちのいずれか一項に記載のデバイス。
(項目18)
上記抽出可能媒体にアクセスする上記手段は、1本以上の極微針を備える、項目1〜17のうちのいずれか一項に記載のデバイス。
(項目19)
上記抽出可能媒体にアクセスする上記手段は、1本以上の中実極微針を備える、項目1〜18のうちのいずれか一項に記載のデバイス。
(項目20)
上記抽出可能媒体にアクセスする上記手段は、1本以上の中空極微針を備える、項目1〜19のうちのいずれか一項に記載のデバイス。
(項目21)
上記抽出可能媒体にアクセスする上記手段は、上記支持構造に対して固定化される、項目1〜20のうちのいずれか一項に記載のデバイス。
(項目22)
上記デバイスは、上記皮膚への曝露後に、上記皮膚から上記抽出可能媒体にアクセスする上記手段を引き抜くことが可能である、項目1〜21のうちのいずれか一項に記載のデバイス。
(項目23)
上記支持構造は、上記抽出可能媒体にアクセスする上記手段に向かう上記被検体の皮膚を引き寄せることが可能である、項目1〜22のうちのいずれか一項に記載のデバイス。
(項目24)
上記支持構造は、真空を上記皮膚に印加することが可能である、項目1〜23のうちのいずれか一項に記載のデバイス。
(項目25)
上記支持構造は、内蔵式真空チャンバを備える、項目1〜24のうちのいずれか一項に記載のデバイス。
(項目26)
上記抽出可能媒体にアクセスする上記手段は、上記支持構造に対して移動することが可能である、項目1〜25のうちのいずれか一項に記載のデバイス。
(項目27)
上記抽出可能媒体にアクセスする上記手段は、上記被検体によって起動可能である、項目1〜26のうちのいずれか一項に記載のデバイス。
(項目28)
上記抽出可能媒体にアクセスする上記手段は、上記デバイスを上記皮膚に適用すると起動される、項目1〜27のうちのいずれか一項に記載のデバイス。
(項目29)
上記デバイスは、熱を上記皮膚に印加する加熱器をさらに備える、項目1〜28のうちのいずれか一項に記載のデバイス。
(項目30)
上記デバイスは、上記皮膚を冷却する冷却器をさらに備える、項目1〜29のうちのいずれか一項に記載のデバイス。
(項目31)
被検体からの抽出可能媒体の分析用のデバイスであって、
該被検体の皮膚に近接して設置されるように構築および配設される支持構造と、
アクセス部位における上記被検体の皮膚から、および/または皮膚を通して該抽出可能媒体にアクセスする流体輸送器と、
該アクセス部位の少なくとも一部分における該皮膚をわたる圧力差を生成することが可能である、該支持構造によって支持される圧力調節器と、
該被検体からの該抽出可能媒体の少なくとも1つの状態を決定する、該支持構造によって支持されるセンサと、
該センサによって決定される該媒体の該状態に関する信号を発生させる、該支持構造によって支持される信号発生器と
を備える、デバイス。
(項目32)
被検体からの抽出可能媒体の分析用のデバイスであって、
アクセス部位における該被検体の皮膚から、および/または皮膚を通して該抽出可能媒体にアクセスする手段と、
該アクセス部位の少なくとも一部分における該皮膚をわたる圧力差を生成することが可能である圧力調節器と、
該被検体からの該抽出可能媒体の少なくとも1つの状態を決定するセンサと、
該センサによって決定される該媒体の該状態に関する信号を発生させるための信号発生器と
を備える、デバイス。
(項目33)
被検体からの抽出可能媒体の分析用のデバイスであって、
アクセス部位における該被検体の皮膚から、および/または皮膚の下から該抽出可能媒体にアクセスする手段と、
チャンバと関連付けられるピストンポンプがない場合に、該アクセス部位の少なくとも一部分における該皮膚をわたる圧力差を生成することが可能である圧力差チャンバと、
該被検体からの該抽出可能媒体の少なくとも1つの状態を決定するセンサと、
該センサによって決定される該媒体の該状態に関する信号を発生させるための信号発生器と
を備える、デバイス。
(項目34)
被検体からの抽出可能媒体を分析する方法であって、
該被検体の皮膚に隣接して、経路を備える分析デバイスを設置することと、
該デバイスが該皮膚に隣接している間に、該抽出可能媒体を該デバイスの該経路と接続するように、該デバイスのアクセス構成要素を起動することと、
該経路を介して該抽出可能媒体を該デバイスの中へ押し進めるように、該デバイスの圧力コントローラを起動することと、
該デバイスのセンサに該媒体を曝露し、該被検体からの該抽出可能媒体の少なくとも1つの状態を決定することと、
該センサによって決定される該媒体の該状態に関する信号を発生させることと
を含む、方法。
(項目35)
被検体の皮膚に近接する部位に適用可能なデバイスであって、
検出される被分析物と反応または相互作用し、視覚によって、感触によって、臭いによって、または味によって検出することができる信号を発生させる作用物質を備え、
被分析物と反応または相互作用する該作用物質および信号伝達作用物質は、同じか、または異なり得、
該信号は、上記被分析物の属性の関数として変化することができ、定性的に分析することができる信号を発出する、デバイス。
(項目36)
被検体の皮膚に近接する部位に適用可能なデバイスであって、
検出される被分析物と反応または相互作用し、視覚によって、感触によって、臭いによって、または味によって検出することができる信号を発生させる作用物質を備え、
被分析物と反応または相互作用する該作用物質と信号伝達作用物質とは、同じか、または異なり得、
該デバイスは、該被検体から流体を取得し、反応のために取得部位から分析部位まで該流体を輸送する、デバイス。
(項目37)
被検体の皮膚に近接する部位に適用可能なデバイスであって、該デバイスは、被検体の物理的状態を決定し、該状態に関係付けられる信号を発出し、該信号は、該被検体によって容易に理解可能ではない、デバイス。
(項目38)
被検体の皮膚に近接する部位においてデバイスを提供することであって、該デバイスは、被検体の物理的状態を決定し、該状態に関係付けられる信号を発出する、ことと、
該信号の表示を取得することと、
該表示を分析する実体に該信号の該表示を輸送することと
を含む、方法。
(項目39)
少なくとも、被検体の第1の物理的状態に関係付けられる第1の信号を生成する第1の分析部位と、該被検体の第2の物理的状態に関係付けられる第2の信号を生成する第2の分析部位とを含む、該被検体の皮膚に近接する複数の分析部位を提供することを含む、方法。
(項目40)
被分析物と反応または相互作用して、アイコンの形態で信号を発生させる反応性作用物質を備える、被検体の皮膚に近接する反応部位を提供することを含む、方法。
(項目41)
被検体の状態を決定するように、該被検体の皮膚に近接する部位に適用可能なデバイスであって、
第1の構成要素と、該部位に適用するために上記第1の構成要素に接続され、該部位に適用した後に該第1の構成要素から分離可能である第2の構成要素とを備え、該第1の構成要素は、該被検体の体液を取得するように起動することができ、該第2の構成要素は、検出される被分析物と反応または相互作用し、視覚によって、感触によって、臭いによって、または味によって検出することができる信号を発生させる作用物質を備える、デバイス。
(項目42)
被検体の唾液の中の被分析物と反応または相互作用して、信号を発生させる作用物質を備える、該被検体によって装着可能なデバイス。
(項目43)
被検体の皮膚に近接する部位に適用可能なデバイスであって、該デバイスは、検出される被分析物と反応または相互作用して、視覚によって、感触によって、臭いによって、または味によって検出することができる信号を発生させる作用物質を備え、
該デバイスは、該信号の発生に関与する該作用物質を備える膜であって、被分析物および/または被分析物指標の通過、ならびに被分析物および/または被分析物指標との反応のうちの1つ以上に対して選択的である、膜を備える、デバイス。
(項目44)
デバイスを緊急看護を必要としている被検体の皮膚に近接して適用することを含み、該デバイスは、被分析物と反応または相互作用して、該被検体の状態を示す信号を発生させる反応性作用物質を備える、方法。
(項目45)
第1の色の複数の第1の粒子と、第2の色の複数の第2の粒子とを含有する溶液に、該溶液の色の変化を引き起こすのに十分な電場および/または磁場を印加することを含む、方法。
(項目46)
少なくとも、第1の決定可能な特性を有する第1の亜集団と、第2の決定可能な特性を有する第2の亜集団とを含む粒子の集団を、サンプルに曝露することと、
該粒子の第1の亜集団のうちの少なくともいくつかの粒子が、結合パートナーを介して、該サンプルの構成要素に結合することを可能にすることであって、該構成要素に結合された該第2の亜集団からの粒子の数に対する、該構成要素に結合された該第1の亜集団からの粒子の数の比が、少なくとも5:1であるように、該粒子の第2の亜集団は、本質的に該構成要素に結合されないままである、ことと、
結合されていない粒子から該構成要素に結合された該粒子を分離することと、
該分離を決定することによって、該サンプルの特性を決定することと
を含む、方法。
(項目47)
結合パートナーを介して、1つの色の粒子を上記サンプルの構成要素に優先的に結合すると、異なる色の粒子の集団の変化によって達成される色変化を視覚化することによって、サンプルの特性を決定することを含む、方法。
Claims (27)
- 被検体の皮膚から、および/または該皮膚の下から引き抜かれた体液の分析用のデバイスであって、該デバイスは、
該被検体の該皮膚の上に接触して設置されるように構築および配設される支持構造と、
アクセス部位における該被検体の該皮膚から、および/または該皮膚の下から該体液にアクセスする、該支持構造と関連付けられる1本以上の極微針と、
該アクセス部位の少なくとも一部分において大気圧に対する負圧を生成することが可能である圧力調節器であって、該圧力調節器は、該デバイスが該皮膚に適用される前に大気圧よりも小さい内圧を有する、製造時に真空排気された事前同梱真空チャンバを備える、圧力調節器と、
該被検体からの該体液の少なくとも1つの状態を決定するセンサと、
該センサによって決定される該体液の該状態に関する信号を発生させる信号発生器と
を備え、
該支持構造は、該1本以上の極微針を該皮膚と接触させるよう移動させ、そして該皮膚との接触後に該1本以上の極微針を該皮膚から後退させるように構築および配設される、デバイス。 - 前記真空チャンバは、前記デバイスが前記皮膚に適用される前に大気圧よりも小さい内圧を有する、請求項1に記載のデバイス。
- 前記真空チャンバは、前記デバイスが前記被検体に使用される時点の前に大気圧よりも小さい内圧を有する、請求項1または2のうちのいずれか一項に記載のデバイス。
- 前記1本以上の極微針は、1本以上の中実極微針を備える、請求項1〜3のうちのいずれか一項に記載のデバイス。
- 前記1本以上の極微針は、1本以上の中空極微針を備える、請求項1〜4のうちのいずれか一項に記載のデバイス。
- 前記デバイスは、前記被検体から流体を引き抜くことが可能である、請求項1〜5のうちのいずれか一項に記載のデバイス。
- 前記流体は、血液を含む、請求項6に記載のデバイス。
- 前記流体は、間質液を含む、請求項6または7に記載のデバイス。
- 前記デバイスは、前記1本以上の極微針と流体的に連絡している貯蔵区画をさらに備え、該貯蔵区画は、前記真空チャンバとは別のものである、請求項6〜8のうちのいずれか一項に記載のデバイス。
- 前記1本以上の極微針を起動し、それにより、前記被検体の前記皮膚から、および/または該皮膚の下から該体液を抽出する、前記支持構造と関連付けられる抽出起動部をさらに備える、請求項1〜9のうちのいずれか一項に記載のデバイス。
- 前記抽出起動部は、前記皮膚に対して配置可能である、請求項10に記載のデバイス。
- 前記支持構造は、前記デバイスを前記皮膚に貼付するための機械的要素をさらに備える、請求項1〜11のうちのいずれか一項に記載のデバイス。
- 前記支持構造は、前記1本以上の極微針を含む陥凹を含む、請求項1〜12のうちのいずれか一項に記載のデバイス。
- 前記支持構造は、前記抽出起動部と流体的に連絡している微小流体チャネルをさらに備える、請求項10に記載のデバイス。
- 前記デバイスは、前記被検体から引き抜かれた流体内に含有される被分析物を決定することが可能である、請求項1〜14のうちのいずれか一項に記載のデバイス。
- 前記デバイスは、後に前記被検体の前記皮膚から該デバイスを除去することなく、前記被分析物を決定することが可能である、請求項15に記載のデバイス。
- 前記デバイスの前記センサは、自動的に前記被分析物を決定することが可能である、請求項15および16のうちのいずれか一項に記載のデバイス。
- 前記デバイスは、前記被分析物の前記決定の結果を表示することが可能である、請求項15〜17のうちのいずれか一項に記載のデバイス。
- 前記デバイスは、前記1本以上の極微針を介して、流体を前記被検体に送達することが可能である、請求項1〜18のうちのいずれか一項に記載のデバイス。
- 前記1本以上の極微針は、前記支持構造に対して固定化される、請求項1〜19のうちのいずれか一項に記載のデバイス。
- 前記支持構造は、前記1本以上の極微針に向かって前記被検体の前記皮膚を引き寄せることが可能である、請求項1〜20のうちのいずれか一項に記載のデバイス。
- 前記1本以上の極微針は、前記被検体によって該被検体の前記皮膚に挿入可能である、請求項1〜21のうちのいずれか一項に記載のデバイス。
- 前記1本以上の極微針は、前記デバイスを前記被検体の前記皮膚に適用すると該被検体の該皮膚に挿入される、請求項1〜22のうちのいずれか一項に記載のデバイス。
- 前記皮膚への前記支持構造の接着のための接着剤を含む、請求項1〜23のうちのいずれか一項に記載のデバイス。
- 前記デバイスは、熱を前記皮膚に印加する加熱器をさらに備える、請求項1〜24のうちのいずれか一項に記載のデバイス。
- 前記デバイスは、前記皮膚を冷却する冷却器をさらに備える、請求項1〜25のうちのいずれか一項に記載のデバイス。
- 被検体の皮膚から、および/または該皮膚の下から引き抜かれた体液の分析用のデバイスであって、該デバイスは、
アクセス部位における該被検体の該皮膚から、および/または該皮膚の下から抽出可能な体液にアクセスするための1本以上の極微針と、
該1本以上の極微針を該皮膚と接触させるよう移動させ、そして該皮膚との接触後に該1本以上の極微針を該皮膚から後退させるように構築および配設される支持構造と、
該アクセス部位の少なくとも一部分において大気圧に対する負圧を生成することが可能である圧力調節器であって、該圧力調節器は、製造時に真空排気された事前同梱真空チャンバを備える、圧力調節器と、
該被検体からの該体液の少なくとも1つの状態を決定するセンサと、
該センサによって決定される該体液の該状態に関する信号を発生させる信号発生器と
を備える、デバイス。
Applications Claiming Priority (11)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US15663209P | 2009-03-02 | 2009-03-02 | |
US61/156,632 | 2009-03-02 | ||
US16371009P | 2009-03-26 | 2009-03-26 | |
US61/163,710 | 2009-03-26 | ||
US26943609P | 2009-06-24 | 2009-06-24 | |
US61/269,436 | 2009-06-24 | ||
US25773109P | 2009-11-03 | 2009-11-03 | |
US61/257,731 | 2009-11-03 | ||
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JP2017121582A (ja) | 2017-07-13 |
EP2408372B1 (en) | 2019-01-09 |
CN102405018A (zh) | 2012-04-04 |
CN102405015B (zh) | 2017-01-18 |
WO2010101620A3 (en) | 2010-11-04 |
CN102405018B (zh) | 2014-11-19 |
US20100256524A1 (en) | 2010-10-07 |
JP2017047298A (ja) | 2017-03-09 |
US20170127990A1 (en) | 2017-05-11 |
CN104434136A (zh) | 2015-03-25 |
US20210330227A1 (en) | 2021-10-28 |
EP2408372A1 (en) | 2012-01-25 |
JP6078230B2 (ja) | 2017-02-08 |
WO2010101626A1 (en) | 2010-09-10 |
WO2010101621A1 (en) | 2010-09-10 |
EP2408369A1 (en) | 2012-01-25 |
WO2010101620A2 (en) | 2010-09-10 |
US10939860B2 (en) | 2021-03-09 |
US20150313522A1 (en) | 2015-11-05 |
JP2015062698A (ja) | 2015-04-09 |
US9775551B2 (en) | 2017-10-03 |
EP3566649A1 (en) | 2019-11-13 |
EP3566649B1 (en) | 2023-06-07 |
US20150087944A1 (en) | 2015-03-26 |
JP2012519052A (ja) | 2012-08-23 |
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