JP2010505534A5 - - Google Patents

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JP2010505534A5
JP2010505534A5 JP2009531522A JP2009531522A JP2010505534A5 JP 2010505534 A5 JP2010505534 A5 JP 2010505534A5 JP 2009531522 A JP2009531522 A JP 2009531522A JP 2009531522 A JP2009531522 A JP 2009531522A JP 2010505534 A5 JP2010505534 A5 JP 2010505534A5
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analyte sensor
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  1. 分析対象を計測するためのシステムであって、該システムが下記成分:
    宿主の循環系と連絡るように構成されている血管アクセス装置;及び、
    血管アクセス装置内に所在するように構成されている分析対象センサーであって、ここで該分析対象センサーは該循環系内の分析対象の濃度を計測するように構成されている、分析対象センサー;を含む、システム。
  2. 流量制御装置を更に含む、請求項1記載のシステム。
  3. 前記流量制御装置がポンプ及び弁の少なくとも1つを含む、請求項2記載のシステム。
  4. 前記流量制御装置が、前記循環系から試料を引き戻すように構成されている、請求項2記載のシステム。
  5. 前記試料が約500マイクロリットル以下の容量を有する、請求項4記載のシステム。
  6. 前記試料が約50マイクロリットル以下の容量を有する、請求項5記載のシステム。
  7. 前記流量制御装置が、約0.001ml/分〜約2.0ml/分の速度で前記試料を引き戻すように構成されている、請求項4記載のシステム。
  8. 前記速度が約0.01ml/分〜約1.0ml/分である、請求項7記載のシステム。
  9. 前記流量制御装置が、前記血管アクセス装置よりも実質的に遠方へは試料を引き戻さないように構成されている、請求項4記載のシステム。
  10. 前記流量制御装置が、宿主の皮膚により定義される平面よりも実質的に遠方へは試料を引き戻さないように構成されている、請求項9記載のシステム。
  11. 前記流量制御装置が前記血管アクセス装置を経由し、そして前記循環系内に流体を輸液するように構成されている、請求項2記載のシステム。
  12. 前記流量制御装置が、前記流体の温度が宿主の温度と実質的に平衡する速度で該流体を輸液するように構成されている、請求項11記載のシステム。
  13. 前記流体が前記分析対象の既知濃度を有し、そしてセンサーが該分析対象の既知濃度に関連するシグナルを計測するように構成された電子機器を含む、請求項12記載のシステム。
  14. 前記分析対象センサーのインビボ部分が約0.020インチ未満の幅を有する、請求項1記載のシステム。
  15. 前記分析対象センサーのインビボ部分が約0.010インチ未満の幅を有する、請求項14記載のシステム。
  16. 前記血管アクセス装置が単一の管腔を含む、請求項1記載のシステム。
  17. 前記血管アクセス装置が18ゲージ以下のカテーテルを含む、請求項1記載のシステム。
  18. 前記血管アクセス装置が22ゲージ以下のカテーテルを含む、請求項17記載のシステム。
  19. 前記血管アクセス装置が側壁及び側壁内に配置された少なくとも1つのオリフィスを含み、ここで該オリフィスは、血液が該オリフィスを通過できるように構成されている、請求項1記載のシステム。
  20. 前記センサーの少なくとも一部分に血液が接触できるように前記オリフィスが構成されている、請求項19記載のシステム。
  21. 前記センサーが先端を有し、ここで該センサーの先端が前記血管アクセス装置内部に配置されている、請求項1記載のシステム。
  22. 前記センサーの先端が、前記血管アクセス装置の先端から約2cm以下に配置されている、請求項21記載のシステム。
  23. 前記センサーの少なくとも一部分が、前記血管アクセス装置の外部に伸長するように構成されている、請求項1記載のシステム。
  24. 前記センサーの少なくとも一部分が、前記血管アクセス装置の外部に間欠的に突出するように構成されている、請求項1記載のシステム。
  25. 前記分析対象センサーが生物不活性物質又は生物活性物質を、該分析対象センサー内に、又は該分析対象センサー上に更に含む、請求項1記載のシステム。
  26. 前記生物活性剤がビタミンK拮抗剤、ヘパリン群の抗凝固剤、血小板凝集阻害剤、酵素、直接トロンビン阻害剤、ダビガトラン、デフィブロチド、デルマタンスルフェート、フォンダパリヌクス及びリバロキサバンよりなる群から選択される物質少なくとも1つを含む、請求項25記載のシステム。
  27. 分析対象を計測するためのシステムであって、該システムが下記成分:
    宿主の循環系と連絡るように構成されている血管アクセス装置;
    血管アクセス装置内に所在するように構成されている分析対象センサー、ここで該分析対象センサーは該循環系内の分析対象の濃度を計測するように構成されている、分析対象センサー;及び、
    流量制御装置、
    を含む、上記システム。
  28. 前記流量制御装置が弁を含む、請求項27記載のシステム。
  29. 前記弁が第1の分別位置及び第2の分別位置を含む、請求項28記載のシステム。
  30. 約0.5秒〜約10.0秒の期間に渡って前記第1の位置と前記第2の位置との間を移動するように前記弁が構成されている、請求項29記載のシステム。
  31. 前記弁に流体接続された配管を更に含み、ここで所定の流速において該配管を通過する流量を計量するように前記弁が構成されている、請求項29記載のシステム。
  32. 前記所定の流速が約0.001ml/分〜約2.0ml/分である、請求項31記載のシステム。
  33. 前記所定の流速が約0.02ml/分〜約0.35ml/分である、請求項32記載のシステム。
  34. 前記弁に接続された配管を更に含み、ここで前記第1の位置と前記第2の位置の間の弁の移動の間、流体約500マイクロリットル以下が該配管を通過するように該弁が構成されている、請求項29記載のシステム。
  35. 前記第1の位置から該第2の位置への弁の移動の間、該配管を通して流体を推進させるように前記システムが構成されている、請求項34記載のシステム。
  36. 前記第2の位置から該第1の位置への弁の移動の間、該配管内に試料を引き戻すよう前記システムが構成されている、請求項35記載のシステム。
  37. 前記第1の位置と該第2の位置の間の弁の移動の間、流体約50マイクロリットル以下が前記配管を通過するように該弁が構成されている、請求項34記載のシステム。
  38. 流体を含有するバッグを更に含む、請求項27記載のシステム。
  39. 前記流体の流量を調節するように構成された流量調節器を更に含む、請求項38記載のシステム。
  40. 局所分析器を更に含む、請求項27記載のシステム。
  41. 前記局所分析器がポテンシオスタットを含む、請求項40記載のシステム。
  42. 前記局所分析器がデータ処理モジュールを含む、請求項40記載のシステム。
  43. 前記局所分析器がデータ格納モジュールを含む、請求項40記載のシステム。
  44. 遠隔分析器を更に含む、請求項27記載のシステム。
  45. 前記遠隔分析器がタッチスクリーンを含む、請求項44記載のシステム。
  46. 前記遠隔分析器が前記流量制御装置を制御するように構成された、請求項44記載のシステム。
  47. 前記遠隔分析器が局所分析器に取り外し可能かつ作動可能に接続されている、請求項44記載のシステム。
  48. 前記遠隔分析器がデータ処理モジュールを含む、請求項44記載のシステム。
  49. 前記遠隔分析器がデータ格納モジュールを含む、請求項44記載のシステム。
  50. 前記流量制御装置が、該流量制御装置を制御するように構成されたプロセッサを含み、ここで該プロセッサは前記遠隔分析器に作動可能に接続されている、請求項44記載のシステム。
  51. 前記流量制御装置がポンプを含む、請求項27記載のシステム。
  52. 宿主の生物学的試料中の分析対象濃度をモニタリングするためのシステムであって、該システムが下記成分:
    実質的に連続した分析対象センサーであって、該センサーの生物学的試料への曝露の間に、宿主中の分析対象濃度を示すデータシグナルを発生させるように構成されている、センサー;
    既知分析対象濃度を有するレファレンス溶液であって、ここで該システムは該レファレンス溶液に該センサーを曝露するように構成され、そしてここで該システムは該レファレンス溶液への該センサーの曝露の間に該レファレンス溶液中の分析対象濃度を示すデータシグナルを発生させるように構成されている、レファレンス溶液;及び、
    キャリブレーション情報を測定し、該キャリブレーション情報より生物学的試料に関連したシグナルをキャリブレーションするように構成されているプログラミングを含むコンピューターシステムであって、ここで該キャリブレーション情報は定常状態情報及び一過性情報を含む、コンピューターシステム;
    を含む、システム。
  53. 前記キャリブレーション情報が、前記レファレンス溶液への前記センサーの曝露に関連するシグナル及び前記生物学的試料への該センサーの曝露に関するシグナルから測定される、請求項52記載のシステム。
  54. 前記定常状態情報が、感度情報及びベースライン情報の少なくとも1つを含む、請求項52記載のシステム。
  55. 前記定常状態情報が、感度情報及びベースライン情報の両方を含む、請求項54記載のシステム。
  56. 定常状態情報が、前記レファレンス溶液への前記センサーの曝露の間に発生したシグナルに関連する情報を含む、請求項52記載のシステム。
  57. 前記レファレンス溶液が約ゼロの既知分析対象濃度を含み、ここで前記定常状態情報が該レファレンス溶液中の前記センサーに関するベースライン情報を含む、請求項56記載のシステム。
  58. 前記レファレンス溶液がゼロより高値の既知分析対象濃度を含み、ここで前記定常状態情報が前記センサーに関する感度情報を含む、請求項56記載のシステム。
  59. 前記定常状態キャリブレーション情報が、実質的に連続した分析対象センサー以外の分析対象センサーに由来するレファレンスデータを含む、請求項52記載のシステム。
  60. 一過性情報が、分析対象濃度のステップ変化への前記センサーの曝露の間に発生したシグナル変化速度を含む、請求項52記載のシステム。
  61. 前記変化速度が、未知分析対象濃度又は非キャリブレーション分析対象濃度の生物学的試料への該センサーの曝露の間に発生したシグナルの速度変化を含む請求項60記載のシステム。
  62. 前記変化速度が、生物学的試料への前記センサーの曝露の間に発生したシグナルの速度変化を含み、ここで前記定常状態情報が、前記実質的に連続した分析対象センサー以外の分析対象センサーに由来するレファレンスデータを含む、請求項60記載のシステム。
  63. 一過性情報が、分析対象濃度のステップ変化への前記センサーの曝露の間に発生したシグナルのインパルス応答を含む、請求項52記載のシステム。
  64. 前記レファレンス溶液に関連するベースライン計測と、生物学的試料に関連するベースライン計測の間のオフセットを測定するために、前記インパルス応答を使用する、請求項63記載のシステム。
  65. 分析対象濃度を得ることができる定常状態計測のある時点を測定するために、前記インパルス応答を使用する、請求項63記載のシステム。
  66. 前記一過性情報が、未知分析対象濃度又は非キャリブレーション分析対象濃度の生物学的試料に関連する複数の時間間隔シグナルに関する定常状態情報及び一過性情報の比較を含む、請求項52記載のシステム。
  67. 前記レファレンス溶液に関連するベースライン計測と生物学的試料に関連するベースライン計測との間のオフセットを測定するために、定常状態情報及び一過性情報の比較を用いる、請求項66記載のシステム。
  68. 定常状態情報及び一過性情報の比較に基づいて、ベースライン又は感度のシフトを検出するためのプログラミングを更に含む、請求項66記載のシステム。
  69. 定常状態情報及び一過性情報の比較に基づいて、ベースライン及び感度の少なくとも1つのシフトに関して補正するために前記シグナルのキャリブレーションを開始するように構成されたプログラミングを更に含む、請求項68記載のシステム。
  70. 定常状態情報及び一過性情報の比較に基づいて、ベースライン及び感度の少なくとも1つのシフトに関して補正するために前記シグナルをキャリブレーションするように構成されたプログラミングを更に含む、請求項69記載のシステム。
  71. シグナルをキャリブレーションするように構成されたプログラミングが、初期キャリブレーション及び更新キャリブレーションの少なくとも1つを実施するように構成されている、請求項52記載のシステム。
  72. 前記分析対象センサーがグルコースセンサーである、請求項52記載のシステム。
  73. 宿主の生物学的試料中の分析対象濃度をモニタリングするためのシステムであって、該システムが下記成分:
    実質的に連続した分析対象センサーであって、該センサーの生物学的試料への曝露の間に宿主中の分析対象濃度を示すデータシグナルを発生させるように構成されている、センサー;
    既知分析対象濃度を有するレファレンス溶液であって、ここで該システムは該レファレンス溶液に該センサーを曝露するように構成され、そしてここで該システムは該レファレンス溶液への該センサーの曝露の間に該レファレンス溶液中の分析対象濃度を示すデータシグナルを発生させるように構成されている、レファレンス溶液;及び、
    キャリブレーション情報を測定し、該キャリブレーション情報より生物学的試料に関連したシグナルをキャリブレーションするように構成されているプログラミングを含むコンピューターシステムであって、ここで該キャリブレーション情報は該レファレンス溶液への該センサーの曝露に関連するシグナル及び生物学的試料への該センサーの曝露に関連するシグナルから測定され、そしてここで該生物学的試料は未知分析対象濃度又は非キャリブレーション分析対象濃度のものである、コンピューターシステム;
    を含む、システム。
  74. キャリブレーション情報が定常状態情報及び一過性情報を含む、請求項73記載のシステム。
  75. 定常状態情報が、感度情報及びベースライン情報の少なくとも1つを含む、請求項74記載のシステム。
  76. 一過性情報が、分析対象濃度の変化への前記センサーの曝露に応答した該センサーのシグナルの変化速度を含む、請求項74記載のシステム。
  77. 一過性情報が、分析対象濃度のステップ変化への前記センサーの曝露の間に発生したシグナルの変化速度を含む、請求項74記載のシステム。
  78. 前記分析対象センサーがグルコースセンサーである、請求項73記載のシステム。
  79. 宿主の生物学的試料中の分析対象濃度をモニタリングするためのシステムであって、該システムが下記成分:
    実質的に連続した分析対象センサーであって、該センサーの生物学的試料への曝露の間に宿主中の分析対象濃度を示すデータシグナルを発生させるように構成されている、センサー
    既知分析対象濃度を有するレファレンス溶液であって、ここで該システムは該レファレンス溶液に該センサーを曝露するように構成され、そしてここで該システムは該レファレンス溶液への該センサーの曝露の間に該レファレンス溶液中の分析対象濃度を示すデータシグナルを発生させるように構成されている、レファレンス溶液;及び
    キャリブレーション情報を測定し、該キャリブレーション情報より生物学的試料に関連したシグナルをキャリブレーションするように構成されているプログラミングを含むコンピューターシステムであって、ここで該キャリブレーション情報は該レファレンス溶液への該センサーの曝露に関連するシグナル及び生物学的試料への該センサーの曝露に関連するシグナルの少なくとも1つから測定され、そしてここで該生物学的試料は未知分析対象濃度又は非キャリブレーション分析対象濃度のものである、コンピューターシステム;
    を含む、システム。
  80. 前記コンピューターシステムが、キャリブレーション情報に応答した前記センサー及び該宿主の少なくとも1つの状態を診断するように構成されたプログラミングを更に含む、請求項79記載のシステム。
  81. キャリブレーション情報がベースライン情報を含み、ここで前記システムがレファレンス溶液に関連するベースラインと生物学的試料に関連するベースラインとの間のオフセットを測定するように構成されているプログラミングを含む、請求項79記載のシステム。
  82. 分析対象濃度のステップ変化への前記センサーの曝露の間に、該センサーのシグナルのインパルス応答を処理することにより前記オフセットを測定する、請求項81記載のシステム。
  83. 未知分析対象濃度又は非キャリブレーション分析対象濃度の生物学的試料の複数の時間間隔試料に関する定常状態情報及び一過性情報の比較により前記オフセットを測定する、請求項81記載のシステム。
  84. 前記コンピューターシステムが、所定量より高値の前記オフセットの変化に応答した妨害物質種を検出するように構成されているプログラミングを更に含む、請求項81記載のシステム。
  85. 前記コンピューターシステムが、所定量より高値の前記オフセットの変化に応答した前記宿主の代謝過程の状態を診断するように構成されているプログラミングを更に含む、請求項81記載のシステム。
  86. 前記コンピューターシステムが、前記状態の診断に応答した前記宿主の状態に関連するメッセージをディスプレイ又は伝送するように構成されているプログラミングを更に含む、請求項85記載のシステム。
  87. 前記コンピューターシステムが、所定量より高値の前記オフセットの変化に応答したエラー及びフェールセーフを診断するように構成されているプログラミングを更に含む、請求項81記載のシステム。
  88. 前記コンピューターシステムが、所定量より高値の前記オフセットの変化に応答した前記センサーを再キャリブレーションするように構成されているプログラミングを更に含む、請求項81記載のシステム。
  89. キャリブレーション情報が感度情報を含み、ここで前記システムは所定量より高値の感度の変化に応答したエラーを診断するように構成されているプログラミングを含む、請求項81記載のシステム。
  90. 前記コンピューターシステムが、分析対象濃度のステップ変化への前記センサーの曝露の間に発生したシグナルのインパルス応答を計算するように構成されているプログラミングを更に含み、ここでステップ変化に対する時間定数をピークインパルス応答の時間から測定する、請求項81記載のシステム。
  91. 前記システムが、インパルス応答計算1回より多く反復するように構成され、ここで前記コンピューターシステムは所定閾値より高値のステップ変化の複数に関連する時間定数の変化に応答したセンサー状態又はエラーを診断するように構成されたプログラミングを更に含む、請求項90記載のシステム。
  92. 分析対象を計測するためのシステムであって、該システムが下記成分:
    宿主の血管系と連絡る血管アクセス装置;及び、
    該血管アクセス装置内に伸長するように構成されている分析対象センサーであって、ここで該分析対象センサーは該血管系内の分析対象の濃度を計測するように構成されている、分析対象センサー
    を含む、システム。
  93. 前記分析対象センサーが前記血管アクセス装置を通って前記宿主の血流中へと伸長するように構成されている、請求項92記載のシステム。
  94. 前記血管アクセス装置がカテーテルである、請求項92記載のシステム。
  95. 前記血管アクセス装置が、前記宿主の静脈内への挿入のために構成されている、請求項92記載のシステム。
  96. 前記血管アクセス装置が、前記宿主の動脈内への挿入のために構成されている、請求項92記載のシステム。
  97. 前記血管アクセス装置が、前記宿主の血圧の計測のための圧力トランスデューサーに作動可能に連結されるように構成されている、請求項92記載のシステム。
  98. 前記血管アクセス装置が、前記宿主の血液化学を計測するための血液化学分析装置に作動可能に連結されるように構成されている、請求項92記載のシステム。
  99. 前記分析対象センサーがグルコースセンサーである、請求項92記載のシステム。
  100. 前記カテーテル内への前記分析対象センサーの挿入の間に、該分析対象センサーを保護するように構成されたシースを更に含む、請求項92記載のシステム。
  101. 前記シースが、該シースからの該分析対象センサーの取り外しを可能にするように構成されたスロットを含む、請求項100記載のシステム。
  102. 第1の末端及び第2の末端を有する流体連結器を更に含み、ここで該流体連結器は該第1の末端前記血管アクセス装置と契合するように構成され、そしてここで前記分析対象センサーの少なくとも一部分は該流体連結器を通して伸長するか、又は該流体連結器内に収容される、請求項92記載のシステム。
  103. 前記流体連結器が該流体連結器上に形成されたセンサー電子機器を含む、請求項102記載のシステム。
  104. 前記センサー電子機器がポテンシオスタットを含む、請求項103記載のシステム。
  105. 前記流体連結器が、前記第2の末端医療装置と契合するように構成されている、請求項102記載のシステム。
  106. 前記医療装置が血圧モニター、血液化学装置、および透析バイパス機よりなる群から選択される装置の少なくとも1つを含む、請求項105記載のシステム。
  107. 前記分析対象センサーが、前記血管アクセス装置から前記宿主の血流内へと約0.010インチ〜約1インチまで伸長するように構成されている、請求項92記載のシステム。
  108. 前記血管アクセス装置および前記分析対象センサーが、インビボの前記宿主の血流内に内在するように構成されている、請求項92記載のシステム。
  109. 前記分析対象センサーに作動可能に接続したセンサー電子機器を更に含む、請求項92記載のシステム。
  110. 前記分析対象センサーが、第1のシグナルを計測するように構成された少なくとも1つのワーキング電極を含む、請求項109記載のシステム。
  111. 前記第1のシグナルが実質的に分析対象関連である、請求項110記載のシステム。
  112. 前記分析対象センサーが、第2のシグナルを計測するように構成された第2のワーキング電極を更に含む、請求項110記載のシステム。
  113. 前記第2のシグナルが実質的に非分析対象関連である、請求項112記載のシステム。
  114. 前記センサー電子機器が、分析対象の濃度を測定するために前記第2のシグナル及び前記第1のシグナルを処理するように構成されている、請求項113記載のシステム。
  115. レファレンス電極を更に含む、請求項110記載のシステム。
  116. 前記レファレンス電極が前記ワーキング電極から遠隔の位置に位置する、請求項115記載のシステム。
  117. 第1の末端及び第2の末端を有する流体連結器を更に含み、ここで該流体連結器は該第1の末端カテーテルと契合するように構成されており、ここで該分析対象センサーの少なくとも一部分は該流体連結器を通して伸長するか、又は該流体連結器内に収容され、そしてここで前記レファレンス電極は該流体連結器に近接するか又は該流体連結器内に位置している、請求項116記載のシステム。
  118. 前記宿主の血流内に伸長する分析対象センサーの末端が拡大した領域を含む、請求項92記載のシステム。
  119. 前記分析対象センサーの実質的な部分が、約0.008インチ未満の直径を有する、請求項92記載のシステム。
  120. 前記分析対象センサーの実質的な部分が、約0.004インチ未満の直径を有する、請求項92記載のシステム。
  121. 前記分析対象センサーが、生物不活性物質又は生物活性物質を、該分析対象センサー内に、又は該分析対象センサー上に更に含む、請求項92記載のシステム。
  122. 前記生物活性剤がビタミンK拮抗剤、ヘパリン群の抗凝固剤、血小板凝集阻害剤、酵素、直接トロンビン阻害剤、ダビガトラン、デフィブロチド、デルマタンスルフェート、フォンダパリヌクス及びリバロキサバンよりなる群から選択される少なくとも1つの物質を含む、請求項121記載のシステム。
  123. 前記分析対象センサーがワーキング電極及びレファレンス電極を含み、ここで該ワーキング電極及び該レファレンス電極の少なくとも1つがワイアを含む、請求項92記載のシステム。
  124. 前記分析対象センサーがワーキング電極及びレファレンス電極を含み、ここで該ワーキング電極及び該レファレンス電極が両方ともワイアであり、そしてここで該ワイアが同軸である、請求項92記載のシステム。
  125. 前記分析対象センサーがワーキング電極及びレファレンス電極を含み、ここで該ワーキング電極及び該レファレンス電極が両方ともワイアであり、そしてここで該ワイアが並置されている、請求項92記載のシステム。
  126. 前記分析対象センサーがワーキング電極及びレファレンス電極を含み、ここで該ワーキング電極及び該レファレンス電極が両方ともワイアであり、そしてここで該レファレンス電極が該ワーキング電極の周囲にらせん状に巻きつけられている、請求項92記載のシステム。
  127. 前記分析対象センサーがワーキング電極を含み、ここで該ワーキング電極は可撓性である、請求項92記載のシステム。
  128. 前記分析対象センサーが該ワーキング電極を含み、ここで該ワーキング電極は可変剛性を有する、請求項92記載のシステム。
  129. 前記分析対象センサーがらせん形状を有する少なくとも1つのワイアを含み、ここで該らせんワイアの可変堅固性は、該らせんワイアの可変ピッチ及び該らせんワイアの可変断面の少なくとも1つにより与えられる、請求項92記載のシステム。
  130. 宿主中の連続分析対象センサーをキャリブレーションするためのシステムであって、該システムが下記:
    宿主内に挿入されるように構成された連続分析対象センサー;
    キャリブレーション溶液であって、該システムは、該連続分析対象センサーの少なくとも一部分にキャリブレーション溶液を曝露すように構成されている、キャリブレーション溶液;及び、
    キャリブレーションされた少なくとも1つのセンサーデータポイントを含むキャリブレーションされた分析対象センサーデータを提供するために、該連続分析対象センサーをキャリブレーションするための手段
    を含む、システム
  131. 前記連続分析対象センサーが、宿主の血流内に内在するように構成されている、請求項130記載のシステム
  132. 前記連続分析対象センサーが、前記宿主におけるグルコース濃度を計測するように構成されている、請求項130記載のシステム
  133. 前記キャリブレーション溶液がグルコースの所定量を含む、請求項132記載のシステム
  134. 前記キャリブレーションされた分析対象センサーデータをディスプレイするための手段を更に含む、請求項130記載のシステム
  135. さらなるキャリブレーション溶液を更に含み、前記システムは、前記連続分析対象センサーの少なくとも一部分にさらなるキャリブレーション溶液を曝露すように構成されている、請求項130記載のシステム
  136. キャリブレーションされた少なくとも1つのセンサーデータポイントを含むキャリブレーションされた分析対象センサーデータを提供するために、該連続分析対象センサーをキャリブレーション又は再キャリブレーションするための手段を更に含む、請求項135記載のシステム
  137. 前記システムが、前記さらなるキャリブレーション溶液を前記連続分析対象センサーの少なくとも一部分に自動的に曝露するように構成されている、請求項135記載のシステム
  138. 前記システムが、前記さらなるキャリブレーション溶液を前記連続分析対象センサーの少なくとも一部分に手動で曝露するように構成されている、請求項135記載のシステム
  139. 非分析対象溶液を更に含み、前記システムが、前記センサーをフラッシュするために、前記連続分析対象センサーの少なくとも一部分に非分析対象溶液を曝露するように構成されている、請求項130記載のシステム
  140. 宿主中の連続分析対象センサーをキャリブレーションするためのシステムであって、該システムが下記:
    宿主内に挿入されるように構成された連続分析対象センサーシステム;
    該宿主から血液試料少なくとも1つを引き出すための手段;及び
    キャリブレーションされたセンサーデータポイント少なくとも1つを含むキャリブレーションされた分析対象センサーデータを提供するために、連続分析対象センサーをキャリブレーションするための手段
    を含む、システム
  141. 前記連続分析対象センサーが前記宿主の血流内に内在するように構成されている、請求項140記載のシステム
  142. 前記連続分析対象センサーが前記宿主のグルコース濃度を計測するように構成されている、請求項140記載のシステム
  143. 前記宿主から血液試料少なくとも1つを引き出すための手段が自動的に実施されるように構成されている、請求項140記載のシステム
  144. 連続分析対象センサーは該血管アクセス装置と一体的に組み込まれ、該血管アクセス装置が、前記宿主の血管系と連絡するように挿されるように構成されている、請求項140記載のシステム
  145. 前記血液試料を引き出すための手段が、前記血管アクセス装置を通して血液試料を引き出すように構成されている、請求項144記載のシステム
  146. 前記宿主の血管系と連絡するように挿入されるように構成された血管アクセス装置を更に含み、ここで前記センサーは該血管アクセス装置を通して挿入される、請求項140記載のシステム
  147. 前記血液試料を引き出すための手段前記血管アクセス装置を通して血液試料を引き出すように構成されている請求項146記載のシステム
  148. 前記キャリブレーションされたセンサーデータをディスプレイするための手段を更に含む、請求項140記載のシステム
  149. 前記連続分析対象センサーシステムに連結されるように構成された血液化学装置を更に含む、請求項140記載のシステム
  150. 前記血液化学装置が、前記宿主の少なくとも1つの血液試料析を実施する、請求項149記載のシステム
  151. 前記血液化学装置が、前記血液試料由来のレファレンス分析対象値測を実施する、請求項149記載のシステム
  152. 連続分析対象センサーシステムであって、該システムが下記成分:
    宿主への挿入のために構成された連続分析対象センサー;及び、
    該連続分析対象センサーに作動可能に接続されたコンピューターシステムであって、ここで該コンピューターシステムは該連続分析対象センサーから分析対象センサーデータを受信するように構成され、該分析対象センサーデータは少なくとも1つのセンサーデータポイント及びキャリブレーション情報を含み、そしてここで該コンピューターシステムは該キャリブレーション情報由来の該分析対象センサーデータをキャリブレーションするように構成されている、コンピューターシステム;
    を含む、システム。
  153. 前記分析対象センサーがグルコースセンサーである、請求項152記載のシステム。
  154. 前記連続分析対象センサーが前記宿主の血管系との連絡のために構成された血管アクセス装置を含み、ここで該連続分析対象センサーは該血管アクセス装置を通して伸長するように構成され、そしてここで該分析対象センサーは該宿主の血管系内の分析対象の濃度を計測するように構成されている、請求項152記載のシステム。
  155. 前記血管アクセス装置が、前記宿主の血液化学を計測するための血液化学分析装置に作動可能に連結されるように構成されている、請求項154記載のシステム。
  156. 前記血液化学装置が前記血管アクセス装置を通して血液試料を引き出すように構成されており、ここで前記キャリブレーション情報は該血液試料又はそれに関連する計測を含む、請求項155記載のシステム。
  157. 前記血液化学装置が前記宿主由来のレファレンス分析対象値を計測するように構成されており、ここで前記キャリブレーション情報は該レファレンス分析対象値を含む、請求項156記載のシステム。
  158. 前記キャリブレーション情報を自動的に得るように構成された装置を更に含み、ここで前記装置は前記センサーシステムに作動可能に連結されている、請求項155記載のシステム。
  159. 前記連続分析対象センサーが前記宿主の血管系との連絡のための構成された血管アクセス装置を含み、ここで該血管アクセス装置は該血管アクセス装置の外部表面上に少なくとも部分的に一体的に組み込まれた分析対象センサーを含み、そして該分析対象センサーに作動可能に接続されたセンサー電子機器を更に含み、そしてここで該センサー電子機器は該宿主の血流内の分析対象の濃度を計測するように構成されている、請求項152記載のシステム。
  160. 前記血管アクセス装置が、前記宿主の血液化学を計測するための血液化学分析装置に作動可能に連結されるように構成されている、請求項159記載のシステム。
  161. 前記血液化学装置が前記血管アクセス装置を通して血液試料を引き出すように構成されており、ここで前記キャリブレーション情報は該血液試料又はそれに関連する計測を含む、請求項160記載のシステム。
  162. 前記血液化学装置が前記宿主由来のレファレンス分析対象値を計測するように構成されており、ここで前記キャリブレーション情報が該レファレンス分析対象値を含む、請求項160記載のシステム。
  163. 前記キャリブレーション情報を自動的に得るように構成された装置を更に含み、ここで該装置は前記センサーシステムに作動可能に連結されている、請求項159記載のシステム。
  164. 前記分析対象センサーがワーキング電極及びレファレンス電極を含み、ここで該ワーキング電極及び該レファレンス電極の少なくとも1つはワイアを含む、請求項152記載のシステム。
  165. 前記分析対象センサーがワーキング電極及びレファレンス電極を含み、ここで該ワーキング電極及び該レファレンス電極が両方ともワイアであり、そしてここで該ワイアが同軸である、請求項152記載のシステム。
  166. 前記分析対象センサーがワーキング電極及びレファレンス電極を含み、ここで該ワーキング電極及び該レファレンス電極が両方ともワイアであり、そしてここで該ワイアが並置されている、請求項152記載のシステム。
  167. 前記分析対象センサーがワーキング電極及びレファレンス電極を含み、ここで該ワーキング電極及び該レファレンス電極が両方ともワイアであり、そしてここで該レファレンス電極が該ワーキング電極の周囲にらせん状に巻きつけられている、請求項152記載のシステム。
  168. 前記分析対象センサーがワーキング電極を含み、ここで該ワーキング電極は可撓性である、請求項152記載のシステム。
  169. 前記分析対象センサーがワーキング電極を含み、ここで該ワーキング電極は可変剛性を有する、請求項152記載のシステム。
  170. 前記分析対象センサーがらせん形状を有する少なくとも1つのワイアを含み、ここで該らせんワイアの可変剛性は、該らせんワイアの可変ピッチ及び該らせんワイアの可変断面の少なくとも1つにより与えられる、請求項152記載のシステム。
  171. 宿主中の分析対象の濃度を計測するためのシステムであって、該システムが下記:
    管アクセス装置、分析対象濃度を計測するように構成された分析対象センサー、及び該センサーに作動可能に接続され、そして該分析対象濃度に関連するシグナルを発生するように構成された電子機器を含み、ここで該分析対象センサーが該血管アクセス装置内に所在するように構成されている分析対象計測システムであって、
    該血管アクセス装置及びセンサー循環系と流体連絡するるように位置決めされるように構成されている、分析対象計測システム
    ファレンス溶液に該分析対象センサーを通過させるための手段;
    該レファレンス溶液の分析対象濃度に関連するシグナルを計測するための手段;
    該循環系から試料を引き戻すための手段;及び、
    該試料の分析対象濃度に関連するシグナルを計測するための手段
    を含む、システム
  172. レファレンス溶液を通過させるための手段が、約0.001ml/分〜約2ml/分の第1の流速で該レファレンス溶液を通過させるように構成されている、請求項171記載のシステム
  173. レファレンス溶液を通過させるための手段が、約0.02ml/分〜約0.35ml/分の第1の流速で該レファレンス溶液を通過させるように構成されている、請求項172記載のシステム
  174. レファレンス溶液を通過させるための手段が、該レファレンス溶液の温度を該宿主の温度と平衡させるように構成されている、請求項172記載のシステム
  175. 試料を引き戻すための手段が、約0.001ml/分〜約2ml/分の第2の流速で該試料を引き戻すように構成されている、請求項171記載のシステム
  176. 試料を引き戻すための手段が、約0.02ml/分〜約0.35ml/分の第2の流速で該試料を引き戻すように構成されている、請求項175記載のシステム
  177. 試料を引き戻すための手段が、前記レファレンス溶液及び該試料の混合を実質的ブロックするように構成されている、請求項175記載のシステム
  178. 前記第2の流速が前記第1の流速と実質的に等しい、請求項175記載のシステム
  179. 前記血管アクセス装置が静脈と流体連絡するように構成されており、前記システムが前記レファレンス溶液に第3の流速で前記センサーを通過させるように更に構成されている、請求項171記載のシステム
  180. 前記第3の流速が前記第1の流速より低値である、請求項179記載のシステム
  181. 前記第3の流速が約1.0μl/分〜約1.0ml/分である、請求項180記載のシステム
  182. 前記第3の流速が約0.02ml/分〜約0.2ml/分である、請求項181記載のシステム
  183. 前記分析対象計測システムが流量制御装置を更に含み、ここで該流量制御装置は流量を計量するように構成されている、請求項171記載のシステム
  184. 前記流量制御装置が第1の分別位置及び第2の分別位置を含む弁を含む、請求項183記載のシステム
  185. レファレンス溶液を通過させる間に、前記第1の位置から前記第2の位置に移するように前記弁が構成されている、請求項184記載のシステム
  186. レファレンス溶液を通過させるための手段が、前記第1の位置から前記第2の位置への弁の移動の間に約500マイクロリットル以下の溶液容量を通過させるように構成されている、請求項185記載のシステム
  187. 試料を引き戻す間に、前記第2の位置から前記第1の位置に移するように前記弁が構成されている、請求項184記載のシステム
  188. 試料を引き戻すための手段が、前記第2の位置から前記第1の位置への弁の移動の間に約500マイクロリットル以下の試料容量を引き戻すように構成されている、請求項187記載のシステム
  189. 試料を引き戻すための手段が、前記第2の位置から前記第1の位置への弁の移動の間に約50マイクロリットル以下の試料容量を引き戻すように構成されている、請求項184記載のシステム
  190. 前記血管アクセス装置が静脈と流体連絡するように構成されており、前記システムが所定の速度で該血管アクセス装置を通過する前記レファレンス溶液の流量を計量するように更に構成されている、請求項184記載のシステム
  191. 前記流量を計測する装置が、前記第1の位置と前記第2の位置との間を移動する弁のタイミングにより少なくとも部分的に制御される、請求項190記載のシステム
  192. 前記循環系から前記試料を引き戻すための手段が、前記血管アクセス装置よりも実質的に遠方とならないように該試料を引き戻すように構成されている、請求項171記載のシステム
  193. 前記循環系から前記試料を引き戻すための手段が、前記宿主の皮膚により定義される平面よりも実質的に遠方とならないように前記血管アクセス装置内に該試料を引き戻すように構成されている、請求項192記載のシステム
  194. 前記分析対象がグルコースであ、請求項171記載のシステム
  195. 前記流量制御装置が弁を含む、請求項183記載のシステム
  196. 前記流量制御装置がポンプを含む、請求項183記載のシステム
  197. 宿主の循環系中の分析対象の濃度を計測するためのシステムであって、該システムが下記:
    管アクセス装置、分析対象センサー、流量制御装置、流体バッグ、IV配管、及びプロセッサを含む分析対象計測システムであって、ここで該プロセッサは該流量制御装置及び該分析対象センサーに作動可能に接続しており、
    血管アクセス装置及び該分析対象センサー該宿主の循環系と流体連絡するように挿入されるように構成されている、分析対象計測システム
    1のレファレンス溶液を該IV配管に注入するための手段及び、
    IV配管に該流体バッグを連結する手段であって、ここで該流体バッグは第2のレファレンス溶液を含む、手段;
    含み、ここで該プロセッサは該システムとのさらなるユーザー相互作用を伴うことなく該分析対象センサーを自動キャリブレーションするように構成されている、システム
  198. 前記第1のレファレンス溶液が第1の既知分析対象濃度を有し、ここで前記第2のレファレンス溶液が第2の既知レファレンス溶液を含む、請求項197記載のシステム
  199. 前記システムが、前記第1のレファレンス溶液及び前記第2のレファレンス溶液を用いて、前記分析対象センサーを自動キャリブレーションするように構成されている、請求項197記載のシステム
  200. 前記システムが、前記IV配管内への別のレファレンス溶液の注入の少なくとも約24時間にわたってキャリブレーションされたセンサーデータを与える、請求項197記載のシステム
  201. 分析対象を計測するためのシステムであって、該システムが下記成分:
    宿主の血管系との挿入連絡のために構成された血管アクセス装置であって、ここで該血管アクセス装置は少なくとも部分的に該血管アクセス装置に組み込まれた分析対象センサーを含む、血管アクセス装置;及び、
    該分析対象センサーに作動可能に接続したセンサー電子機器、ここで該センサー電子機器は血管系内の分析対象の濃度を計測するように構成されている、センサー電子機器;
    を含む、システム。
  202. 前記センサー電子機器が前記分析対象濃度を実質的に連続的に計測するように構成されている、請求項201記載のシステム。
  203. 前記分析対象がグルコースである、請求項201記載のシステム。
  204. 前記血管アクセス装置が、前記宿主の血液化学を計測するための血液化学分析装置に作動可能に連結されるように構成されている、請求項201記載のシステム。
  205. 前記分析対象センサーが、第1のシグナルを計測するように構成された少なくとも1つのワーキング電極を含む、請求項201記載のシステム。
  206. 前記第1のシグナルが実質的に分析対象関連である、請求項205記載のシステム。
  207. 前記分析対象センサーが第2のシグナルを計測するように構成された第2のワーキング電極を更に含む、請求項205記載のシステム。
  208. 前記第2のシグナルが実質的に非分析対象関連である、請求項207記載のシステム。
  209. 前記センサー電子機器が、分析対象の濃度を測定するために前記第2のシグナル及び前記第1のシグナルを処理するように構成されている、請求項207記載のシステム。
  210. 前記分析対象センサーがレファレンス電極を更に含む、請求項205記載のシステム。
  211. 前記レファレンス電極が該レファレンス電極から遠隔な位置に位置する、請求項210記載のシステム。
  212. 前記レファレンス電極が前記宿主の血流の外部に位置するように構成されている、請求項211記載のシステム。
  213. 前記分析対象センサーが逆電極を更に含む、請求項210記載のシステム。
  214. 前記分析対象センサーが、該分析対象センサー内に前記血管アクセス装置が挿入された場合に、前記宿主のインビボの血流に少なくとも部分的に接触するように構成されている、請求項201記載のシステム。
  215. 前記分析対象センサーが、前記血管アクセス装置の外部表面上に付着している、請求項201記載のシステム。
  216. 前記分析対象センサーが、前記血管アクセス装置の外部表面上に電気メッキされている、請求項215記載のシステム。
  217. 前記分析対象センサーが、前記センサー電子機器の少なくとも一部分に有線接続されている、請求項201記載のシステム。
  218. 前記分析対象センサーが、前記センサー電子機器の少なくとも一部分に無線接続されている、請求項201記載のシステム。
  219. 前記血管アクセス装置がカテーテルである、請求項201記載のシステム。
  220. 前記分析対象センサーが生物不活性物質又は生物活性物質を該分析対象センサー内に組み込んで更に含む、請求項201記載のシステム。
  221. 前記生物活性剤がビタミンK拮抗剤、ヘパリン群の抗凝固剤、血小板凝集阻害剤、酵素、直接トロンビン阻害剤、ダビガトラン、デフィブロチド、デルマタンスルフェート、フォンダパリヌクス及びリバロキサバンよりなる群から選択される少なくとも1つの物質を含む、請求項220記載のシステム。
  222. 前記分析対象センサーがワーキング電極及びレファレンス電極を含み、ここで該ワーキング電極及び該レファレンス電極の少なくとも1つがワイアを含む、請求項201記載のシステム。
  223. 宿主の血管系における分析対象を計測するために構成された分析対象センサーを製造するための方法であって、該方法が下記工程:
    血管アクセス装置を提供する工程;及び、
    該血管アクセス装置中、又は該血管アクセス装置の表面上に分析対象センサーを少なくとも部分的に一体的に組み込む工程;
    を含む、方法。
  224. 分析対象センサーを少なくとも部分的に一体的に組み込む工程が、前記血管アクセス装置の内部表面上、又は該血管アクセス装置の外部表面上に少なくとも1つのワーキング電極を付着させることを含む、請求項223記載の方法。
  225. 前記付着工程が、前記血管アクセス装置の外部表面上に前記ワーキング電極を電気メッキすることを更に含む、請求項223記載の方法。
  226. 分析対象センサーを少なくとも部分的に一体的に組み込む工程が、前記血管アクセス装置の内部表面上、又は該血管アクセス装置の外部表面上に第2のワーキング電極を付着させることを更に含む、請求項223記載の方法。
  227. 分析対象センサーを少なくとも部分的に一体的に組み込む工程が、前記血管アクセス装置の内部表面上、又は該血管アクセス装置の外部表面上にレファレンス電極を付着させることを更に含む、請求項223記載の方法。
  228. 分析対象センサーを少なくとも部分的に一体的に組み込む工程が、前記血管アクセス装置の内部表面上、又は該血管アクセス装置の外部表面上に逆電極を付着させることを更に含む、請求項223記載の方法。
  229. 前記血管アクセス装置の表面が外部表面、内部表面、及び先端表面よりなる群から選択される、請求項223記載の方法。
  230. 分析対象センサーを少なくとも部分的に一体的に組み込む工程が、前記ワーキング電極から遠隔な位置にレファレンス電極を形成することを更に含む、請求項223記載の方法。
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