JP5085653B2 - 凝縮グルーコース分析器 - Google Patents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/08—Detecting, measuring or recording devices for evaluating the respiratory organs
- A61B5/083—Measuring rate of metabolism by using breath test, e.g. measuring rate of oxygen consumption
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/1486—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using enzyme electrodes, e.g. with immobilised oxidase
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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- Y10T436/14—Heterocyclic carbon compound [i.e., O, S, N, Se, Te, as only ring hetero atom]
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Description
105 使い捨ての呼吸管105
110 センサ
115 冷却装置
120 円形
130 塩化物
135 小型圧力変換器
140 ヒドロゲル・ポリマー
145 グルコースセンサ
150 較正センサ
Claims (16)
- 呼吸する生体の血中グルコース濃度とその変動とをモニタリングするための装置であって、
a.前記呼吸する生体から少なくとも一呼気又は呼気成分を採集するための呼気採集貯蔵器を備え、前記呼気採集貯蔵器は、呼気凝縮液採集貯蔵器を含み、又は該呼気凝縮液採集貯蔵器に接続されており、
b.前記呼気凝縮液採集貯蔵器は、少なくとも1つのセンサを含み、又は該少なくとも1つのセンサに接続されており、前記少なくとも一呼気又は呼気成分からの呼気凝縮液が前記少なくとも1つのセンサと接触し、
c.前記少なくとも1つのセンサは、前記呼気凝縮液採集貯蔵器に採集された呼気凝縮液に接触するとグルコースの濃度及び少なくとも1つの希釈性指標の濃度を測定する手段を含み、
d.前記少なくとも1つのセンサは、少なくとも1つのプロセッサに動作可能なように接続され、前記プロセッサには、前記少なくとも1つのセンサに接触している採集された呼気凝縮液内のグルコース及び希釈性指標の検出濃度を表す信号が、前記センサから送信され、
e.前記プロセッサは、前記少なくとも1つのセンサから少なくとも1つの信号を受信すると、前記呼気凝縮液中の測定されたグルコース濃度を、前記呼気凝縮液中の希釈性指標によって除算し、血液中の前記希釈性指標の濃度を表す数を乗算することにより、グルコースの血中濃度を計算する、
ことを特徴とする装置。 - a.当該装置は、非侵襲性、携帯型、又は双方であること、
b.前記呼気採集貯蔵器は、前記少なくとも一呼気又は呼気成分から凝縮液を抽出するための手段を含むこと、
c.前記呼気採集貯蔵器は、少なくとも1つの呼吸管内に含まれること、
d.前記少なくとも1つのセンサは、抗体、酵素、オリゴヌクレオチド、ペプチド類、又は蛋白からなるグループから選択された少なくとも1つのグルコース結合分子を含む親水性ヒドロゲルを含むこと、
e.前記少なくとも1つのセンサは、前記呼気凝縮液中のグルコース濃度を測るための1つのセンサと、前記呼気凝縮液中の希釈性指標の濃度を測定するためのもう1つのセンサとを含むこと、
f.前記少なくとも1つのセンサは、マイクロ重量計センサ技術、電気化学的センサ技術、ガスクロマトグラフィ/質量分析センサ技術、赤外分光学センサ技術、イオン移動度スペクトロメトリ・センサ技術、厚みすべりモード・センサ技術、光イオン化センサ技術、増幅蛍光ポリマ・センサ技術、ファイバオプティック微小球体センサ技術、嵌合微小電極配列センサ技術、マイクロ電気機械センサ技術、半導体ガスセンサ技術、導電性高分子材料ガスセンサ技術、弾性表面波ガスセンサ技術、および、高電子移動度トランジスタに基づくセンサ技術、高電子移動度トランジスタ−直線流センサ技術、又はその組合せを含むこと、
g.前記プロセッサは、インジケータ手段に動作可能なように接続され、前記計算が完了すると、前記計算のアウトプットが、前記少なくとも一呼気又は呼気成分が採集された前記生体の前記血中グルコース濃度の表示を提供する前記インジケータ手段に送信されること、
h.前記プロセッサは、前記計算のアウトプットが、所望の血中グルコース濃度の単位で前記プロセッサにより提供されるように、全ての計測単位の変換に合わせて適切なファクターにより調整されること、
のうち、少なくとも1つ、又はそれらの組み合わせが適用される請求項1記載の装置。 - a.前記採集される呼気成分は、呼気終末の呼気であること、
b.前記グルコース結合分子は、グルコース・オキシダーゼ、グルコースデヒドロゲナーゼ、およびグルコース・ヘキソキナーゼからなるグループから、又はグルコース−6リン酸塩デヒドロゲナーゼ若しくはヘキソキナーゼから選択されること、
c.前記呼気又は呼気成分から凝縮液を抽出するための手段は、前記採集貯蔵器を取り囲むか、さもなければ、前記採集貯蔵器の温度に対する制御を達成するために十分な接触状態にあるペルチェ装置を含むこと、
d.前記呼気又は呼気成分から凝縮液を抽出するための手段は、前記少なくとも一吐出呼気のサンプル又はその成分を、体温より低い温度に冷却することによって凝縮液を抽出すること、
e.前記希釈性指標は、前記生体の血液中で厳密に調節され、かつ、気道内流体中及び血液中において実質的に同一の濃度で前記生体内に存在する血液成分であること、
のうち、少なくとも1つ、又はその組合せが適用される請求項2記載の装置。 - a.前記体温より低い温度は、体温より低い摂氏10〜15度からなるグループから選択された温度、又は、摂氏20.6度若しくは摂氏−17.8度の温度であること、
b.前記希釈性指標は、塩化物、ナトリウム、カリウム、尿素、およびその組合せから選択されること、
c.気道内流体からの前記少なくとも一吐出呼気又はその成分は、肺胞内面流体、毛細管内皮細胞からの流体、およびその組合せから主に構成されること、
d.患者の呼気のサンプルの分析から生じたデータは、記憶されるか、送信されるか、又は双方であること、
e.患者の呼気のサンプル内のグルコース濃度は、健康な患者と関連付けられている所定の標準的なグルコース濃度と比較されること、
f.前記グルコース濃度は、異常であると確定されること、
g.前記グルコース濃度は、対象者に通知されること、
のうち、少なくとも1つ、又はその組合せが適用される請求項3記載の装置。 - a.当該装置は、非侵襲性、携帯型、又は双方であり、
b.前記呼気採集貯蔵器は、前記少なくとも一呼気又は呼気成分から凝縮液を抽出するための手段を含み、
c.前記呼気又は呼気成分は、呼気終末の呼気であり、
d.前記少なくとも1つのセンサは、前記呼気凝縮液中のグルコース濃度を測るための1つのセンサと、前記呼気凝縮液中の希釈性指標の濃度を測定するためのもう1つのセンサとを含み、
e.前記少なくとも1つのセンサは、抗体、酵素、オリゴヌクレオチド、ペプチド類又は蛋白からなるグループから選択された少なくとも1つのグルコース結合分子を含む親水性ヒドロゲルを含み、また、前記少なくとも1つのセンサは、マイクロ重量計センサ技術、電気化学的センサ技術、ガスクロマトグラフィ/質量分析センサ技術、赤外分光学センサ技術、イオン移動度スペクトロメトリ・センサ技術、厚みすべりモード・センサ技術、光イオン化センサ技術、増幅蛍光ポリマ・センサ技術、ファイバオプティック微小球体センサ技術、嵌合微小電極配列センサ技術、マイクロ電気機械センサ技術、半導体ガスセンサ技術、導電性高分子材料ガスセンサ技術、弾性表面波ガスセンサ技術、および、高電子移動度トランジスタに基づくセンサ技術、高電子移動度トランジスタ−直線流センサ技術、又はその組合せを含み、
f.前記プロセッサは、インジケータ手段に動作可能なように接続され、前記計算が完了すると、前記計算のアウトプットが、前記少なくとも一呼気又は呼気成分が採集された前記生体の前記血中グルコース濃度の表示を提供する前記インジケータ手段に送信されること、
ことを特徴とする請求項1記載の装置。 - a.前記グルコース結合分子は、グルコース・オキシダーゼ、グルコースデヒドロゲナーゼ、およびグルコース・ヘキソキナーゼからなるグループから選択され、
b.前記呼気又は呼気成分から凝縮液を抽出するための手段は、前記採集貯蔵器を取り囲むか、さもなければ、前記採集貯蔵器の温度に対する制御を達成するために十分な接触状態にあるペルチェ装置を含み、
c.前記呼気又は呼気成分から凝縮液を抽出するための手段は、前記少なくとも一吐出呼気のサンプル又はその成分を、体温より低い温度に冷却することによって凝縮液を抽出し、
d.前記希釈性指標は、前記生体の血液中で厳密に調節され、かつ、気道内流体中及び血液中において実質的に同一の濃度で前記生体内に存在する血液成分である、
ことを特徴とする請求項5記載の装置。 - a.前記体温より低い温度は、体温より低い摂氏10〜15度からなるグループから選択された温度、又は、摂氏20.6度若しくは摂氏−17.8度の温度であり、
b.前記希釈性指標は、塩化物、ナトリウム、カリウム、およびその組合せから選択され、
c.気道内流体からの前記少なくとも一吐出呼気又はその成分は、肺胞内面流体、毛細管内皮細胞からの流体、およびその組合せから主に構成される
ことを特徴とする請求項6記載の装置。 - a)少なくとも一吐出呼気のサンプルを採集するための少なくとも1つの採集貯蔵器であって、センサおよび信号伝達手段を含み、前記センサ、前記信号伝達手段、又は、双方のどちらかは、少なくとも1つのプロセッサを含むか、該プロセッサと有効な通信状態にある、採集貯蔵器と、
b)前記吐出呼気サンプルから前記凝縮液を抽出するための手段と
を備え、
前記センサは、抽出された凝縮液中のグルコースおよび濃度が希釈性指標として使用される少なくとも1つの溶質を特定するよう備わっており、前記少なくとも1つの溶質の濃度は、厳密に血液中で調整されており、気道内流体においてと血液中においてで実質的に同一であり、血液中のグルコース濃度を、抽出された凝縮液中の特定されたグルコースに相関させる際に、前記凝縮液中のグルコース濃度に乗算される希釈比として利用される希釈比を決定するための、血液中の同様の溶質の濃度に対する比率として、前記プロセッサに用いられる、
ことを特徴とする請求項1記載の非侵襲性・携帯型グルコース・モニタリング機器。 - 少なくとも1つのプロセッサと、少なくとも一吐出呼気のサンプルから凝縮液を抽出して採集するための少なくとも1つの採集貯蔵器とを備え、
前記採集貯蔵器は、センサと信号伝達手段とを含み、
前記センサは、抽出された凝縮液中のグルコースおよび少なくとも1つの溶質を特定するよう備わっており、前記少なくとも1つの溶質の濃度は、厳密に血液中で調整されており、気道内流体においてと血液中においてで実質的に同一であり、血液中のグルコース濃度を、抽出された凝縮液中の特定されたグルコースに相関させる際に、前記凝縮液中のグルコース濃度に乗算される希釈比として利用される希釈比を決定するための、血液中の同様の溶質の濃度に対する比率として、前記プロセッサに用いられる、
ことを特徴とする非侵襲性・携帯型グルコース・モニタリング機器。 - a.対象者から少なくとも一吐出呼気のサンプル又はその成分を採集し、
b.前記少なくとも一吐出呼気のサンプルから凝縮液を抽出し、
c.前記凝縮液中のグルコース濃度を決定するために、グルコースセンサを前記凝縮液に接触させ、かつ、前記凝縮液中の少なくとも1つの電解質の濃度を決定するために、電解センサを前記凝縮液に接触させ、その濃度は、血液中で厳密に調節され、気道内流体においてと血液中においてで実質的に同一であり、
d.血液中の前記少なくとも1つの電解質の濃度に対する、前記凝縮液中の前記少なくとも1つの電解質の前記濃度の比率を取得し、
e.前記対象者の血液中のグルコース濃度を得るために、前記比率を前記凝縮液中の前記グルコース濃度に乗算すること、
を含む対象者の吐出呼気サンプルから血液中のグルコース濃度を測定する方法。 - 前記少なくとも一吐出呼気のサンプル又はその成分は、呼気終末の呼気サンプルである請求項10記載の方法。
- 前記電解質は、ナトリウム、カリウム、およびその組合せからなるグループから選択される請求項11記載の方法。
- 前記電解質が塩化物である請求項12記載の方法。
- 前記方法は、高血糖症、低血糖症、又は双方、および高血糖症と低血糖症の間の変動を検出するのに用いられる請求項10記載の方法。
- 請求項1記載の装置を用いることを含む血中グルコース濃度をモニタリングする方法。
- a.対象者からの呼気又は呼気成分を、呼気凝縮液採集貯蔵器を含むか、呼気凝縮液採集貯蔵器に接続された呼気採集貯蔵器に採集し、
b.少なくとも1つのセンサを前記呼気凝縮液採集貯蔵器に採集された呼気凝縮液に接触させ、
c.前記呼気凝縮液採集貯蔵器に採集された前記呼気凝縮液を、前記少なくとも1つのセンサに接触させ、グルコースの濃度および少なくとも1つの希釈性指標の濃度を測定し、
d.前記少なくとも1つのセンサと接触して採集された呼気凝縮液から測定された、前記グルコースおよび前記少なくとも1つの希釈性指標の濃度を用いて、前記呼気凝縮液中の希釈性指標濃度によって前記呼気凝縮液中の測定されたグルコース濃度を除算し、血液中の前記希釈性指標の濃度を表す数を乗算することによって、グルコースの血中濃度を計算すること、
を含む血中グルコース濃度をモニタリングする方法。
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US11/504,335 US7914460B2 (en) | 2006-08-15 | 2006-08-15 | Condensate glucose analyzer |
US11/504,335 | 2006-08-15 | ||
PCT/US2007/071469 WO2008021617A1 (en) | 2006-08-15 | 2007-06-18 | Condensate glucose analyzer |
USPCT/US2007/071469 | 2007-06-18 | ||
PCT/US2007/075985 WO2008022183A1 (en) | 2006-08-15 | 2007-08-15 | Condensate glucose analyzer |
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JP2010515009A JP2010515009A (ja) | 2010-05-06 |
JP5085653B2 true JP5085653B2 (ja) | 2012-11-28 |
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JP2009524781A Expired - Fee Related JP5085653B2 (ja) | 2006-08-15 | 2007-08-15 | 凝縮グルーコース分析器 |
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US (2) | US7914460B2 (ja) |
EP (1) | EP2051621A1 (ja) |
JP (1) | JP5085653B2 (ja) |
CN (1) | CN101505653A (ja) |
CA (1) | CA2660122C (ja) |
WO (1) | WO2008021617A1 (ja) |
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2007
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US7914460B2 (en) | 2011-03-29 |
US20080045825A1 (en) | 2008-02-21 |
JP2010515009A (ja) | 2010-05-06 |
WO2008021617A1 (en) | 2008-02-21 |
EP2051621A1 (en) | 2009-04-29 |
WO2008021617A8 (en) | 2008-04-24 |
CA2660122A1 (en) | 2008-02-21 |
US20100216175A1 (en) | 2010-08-26 |
CN101505653A (zh) | 2009-08-12 |
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