JP2013509944A - 血中グルコース測定値をレシオメトリック補正するための改良された光学式センサ構成 - Google Patents
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Abstract
【選択図】図5
Description
糖尿病患者および重篤な患者のグルコース濃度を調節するため、臨床医は、数十年にわたってインスリンを使用してきたが、的確な用量を決定することは依然として問題である。インスリンは、多くのホルモンおよび多種類の細胞が関与する一連の複雑な相互作用を介して、循環するグルコース濃度を低下させる。インスリンの用量決定プロトコルは、膵臓によるインスリンの生理的分泌を再現することを試みている。しかしながら、固定時間および血中グルコース測定値に基づくアルゴリズムに従った投与は、生物学的に利用可能な(bioavailable)グルコース量および人体の要求に応じてインスリン産生を絶え間なく調整する健康な個人の能力に大雑把に近似することしかできない。したがって、患者の血中グルコースを適当な濃度に維持するために投与すべきインスリンの的確な量を決定するためには、血液中を循環している生物学的に利用可能なグルコースの量を、ほぼリアルタイムで正確に測定する必要がある。
図1A〜Dを参照して、先行技術のある実施形態(米国特許出願公開第2008/0188725号明細書を参照)が示されている。図1Aのグルコースセンサ117は、ファイバの側面を貫いて一連の穴116が直線状にあけられた光ファイバである。ある実施形態では、穴116に、1種以上のグルコース感知化学指示薬系が充填されている。選択的透過性膜でこれらの穴を覆うことができ、膜の透過性は、化学指示薬系の分子(例えばフルオロフォアおよび消光剤)が空洞内に保持されるが、グルコースは自由に透過することができるように選択される。ある実施形態では、グルコースセンサ117を貫通してあけられた一連の穴116は、水平方向に等間隔に配置され、グルコースセンサ117の側面に沿って均一に回転されて、渦巻形または螺旋形配置を形成している。ある実施形態では、この一連の穴は、グルコースセンサの直径に沿ってあけられている。
ある実施形態では、ヒドロゲルが、複数のフルオロフォア系と結びついている。ある実施形態では、フルオロフォア系が、グルコースレセプタ部位を有する消光剤を含む。ある実施形態では、グルコースレセプタに結合するグルコースが存在しない場合、消光剤は、励起光によって染料が励起されたときにフルオロフォア系が光を発することを防ぐ。ある実施形態では、グルコースレセプタに結合するグルコースが存在する場合、消光剤は、励起光によって染料が励起されたときにフルオロフォア系が光を発することを可能にする。
a)第1の窒素に、ペンダント反応性基を有する第1の芳香族基が結合しており、第2の窒素に、少なくとも1つのペンダントボロン酸基を有する第2の芳香族基が結合しており、
b)第1の窒素に結合した第1の芳香族基に、1つまたは複数のボロン酸基が結合しており、第2の窒素に結合した第2の芳香族基に、1つのボロン酸基および反応性基が結合しており、
c)第1の窒素に結合した第1の芳香族基に、1つのボロン酸基および反応性基が結合しており、第2の窒素に結合した第2の芳香族基に、1つのボロン酸基および反応性基が結合しており、
d)2つのそれぞれの窒素に結合した芳香族基に、1つのボロン酸基が結合しており、中心に位置する複素芳香族基の複素芳香族環の炭素に、反応性基が結合している。
HPTS−CysMAの溶液(pH7.4のPBS中の1×10−5M溶液)に、3,3’−oBBV(MeOH中の30mM溶液)を、量を増やしながら加え、加える毎に蛍光発光を測定した。図15は、3,3’−oBBV(Q)を加えたときの発光の相対変化(Stern−Volmer曲線)を示し、この変化は、3,3’−oBBVによるHPTS−CysMAの消光を示している。蛍光計の設定は以下のとおりである:1%減衰、ex slit 8nm、em slit 12nm、486nm ex λ、537nm em λ。
HPTS−CysMA(2mg)、3,3’−oBBV(15mg)、N,N’−ジメチルアクリルアミド(400mg)、N,N’−メチレンビスアクリルアミド(8mg)、HCl(1M溶液を10μL)およびVA−044(1mg)を水に溶解し、体積測定フラスコ中で1mLに希釈した。この溶液を、凍結脱気(3回)し、0.005”のポリイミドスペーサを含む型に注入し、55℃で、16時間、重合させた。得られたフィルムをpH7.4のリン酸緩衝液に入れ、このフィルムを、フローセル構成中で、グルコースの量を段階的に増やして(0、50、100、200、400mg/dL)試験した。グルコースを加えたときの蛍光の相対変化を図17に示す。蛍光計の設定は以下のとおりである:ex slit 8nm、em slit 3.5nm、515nm カットオフフィルタ、486nm ex λ、532nm em λ。
Claims (27)
- 血管内の検体濃度を検出するセンサであって、
近位端および遠位端を有する光ファイバと、
近位端および遠位端を有する非外傷性先端部であり、非外傷性先端部と前記光ファイバの間に間隙が存在するような態様で、非外傷性先端部の前記近位端が前記光ファイバの前記遠位端から分離されている、非外傷性先端部と、
近位端および遠位端を有するロッドであり、ロッドの前記近位端が前記光ファイバの前記遠位端に取り付けられており、ロッドが前記間隙を横切り、ロッドが前記光ファイバを前記非外傷性先端部に結合するような態様で、ロッドの前記遠位端が前記非外傷性先端部の前記近位端に取り付けられている、ロッドと、
前記間隙に配置された化学指示薬系であり、励起光信号に応答して発光光信号を生成することができ、前記発光光信号の強度が前記検体濃度に関係している、化学指示薬系と、
前記間隙を覆うように配置された選択的透過性膜と
を備え、前記センサが前記血管内に配置されるようにサイズが決められている
センサ。 - 前記化学指示薬系がさらに、前記間隙の中でヒドロゲルによって固定化されている、請求項1に記載のセンサ。
- 温度センサをさらに備える、請求項1に記載のセンサ。
- 前記光ファイバの直径が約0.005インチ〜約0.020インチの間にある、請求項1に記載のセンサ。
- 反射領域をさらに備える、請求項1に記載のセンサ。
- 前記反射領域が、前記ロッドの前記近位端の反射面を含む、請求項5に記載のセンサ。
- 前記ロッドが、加熱によって前記光ファイバに取り付けられている、請求項1に記載のセンサ。
- 前記ロッドが、反射性の接着剤によって前記光ファイバに取り付けられている、請求項1に記載のセンサ。
- 前記非外傷性先端部の前記遠位端の形状が、前記血管内の外傷を低減させるように形成されており、半球形、放物線形および楕円形からなる群から選択される、請求項8に記載のセンサ。
- 前記非外傷性先端部の前記遠位端が可撓性である、請求項1に記載のセンサ。
- 前記非外傷性先端部の前記遠位端が変形可能である、請求項1に記載のセンサ。
- 前記非外傷性先端部の前記遠位端が、プラスチック、ポリマー、ゲル、金属および複合材料からなる群から選択される少なくとも1種の材料から形成されている、請求項1に記載のセンサ。
- 前記ロッドが、金属、金属合金、プラスチック、ポリマー、セラミックおよび複合材料からなる群から選択される少なくとも1種の材料から形成されている、請求項1に記載のセンサ。
- 前記ロッドが、ステンレス鋼、チタンまたはニチノールから形成されている、請求項13に記載のセンサ。
- 前記ロッドが円筒形である、請求項1に記載のセンサ。
- 前記ロッドの直径が約0.002インチ〜約0.010のインチの間にある、請求項15に記載のセンサ。
- 前記ロッドが可撓性である、請求項1に記載のセンサ。
- 前記ロッドが前記光ファイバよりも堅い、請求項1に記載のセンサ。
- 前記ロッドが、前記センサが前記間隙に沿って撓曲することを防ぐのに充分な堅さを有する、請求項1に記載のセンサ。
- 血管内の検体濃度を検出するセンサであって、
近位端および遠位端を有する光ファイバと、
近位端および遠位端を有する非外傷性先端部であり、非外傷性先端部と前記光ファイバの間に間隙が存在するような態様で、非外傷性先端部の前記近位端が前記光ファイバの前記遠位端から分離されている、非外傷性先端部と、
近位端および遠位端を有するハイポチューブであり、ハイポチューブの前記近位端が前記光ファイバの前記遠位端に取り付けられており、ハイポチューブが前記間隙を横切り、ハイポチューブが前記光ファイバを前記非外傷性先端部に結合するような態様で、ハイポチューブの前記遠位端が前記非外傷性先端部の前記近位端に取り付けられており、前記間隙の上に開いた少なくとも1つの窓をハイポチューブが備える、ハイポチューブと、
前記間隙に配置された化学指示薬系であり、励起光信号に応答して発光光信号を生成することができ、前記発光光信号の強度が前記検体濃度に関係している、化学指示薬系と、
前記少なくとも1つの窓を覆うように配置された選択的透過性膜と
を備え、前記センサが前記血管内に配置されるようにサイズが決められている
センサ。 - 前記化学指示薬系がさらに、前記間隙の中でヒドロゲルによって固定化されている、請求項20に記載のセンサ。
- 血管内の検体濃度を検出するセンサであって、
近位端および遠位端を有する光ファイバと、
近位端および遠位端を有する非外傷性先端部であり、非外傷性先端部と前記光ファイバの間に間隙が存在するような態様で、非外傷性先端部の前記近位端が前記光ファイバの前記遠位端から分離されている、非外傷性先端部と、
前記光ファイバと前記非外傷性先端部とを接続するケージであり、ケージの中に、前記光ファイバが少なくとも部分的に囲われており、少なくとも1つの窓をケージが有する、ケージと、
前記ケージ内に配置された化学指示薬系であり、前記窓に隣接して位置し、選択的透過性膜によって検体から分離されており、励起光信号に応答して発光光信号を生成することができ、前記発光光信号の強度が前記検体濃度に関係している、化学指示薬系と、
前記励起光信号が前記化学指示薬系に入る前に前記励起光信号の一部を反射するように構成され、または第2の発光光信号を返すように構成された基準材料であり、前記第2の発光光信号の強度が前記検体濃度に関係していない、基準材料と
を備えるセンサ。 - 血管内の検体濃度を検出するセンサであって、
近位端および遠位端を有する光ファイバであり、光ファイバの前記遠位端がグルコース感知ヒドロゲルを含み、前記グルコース感知ヒドロゲルが、第1のフルオロフォア、消光剤および少なくとも1つのグルコース結合部分構造を含む、光ファイバと、
前記光ファイバに隣接し、近位端および遠位端を有する基準ファイバであり、基準ファイバの前記遠位端が基準材料を含み、前記基準材料が第2のフルオロフォアを含む、基準ファイバと、
前記グルコースファイバおよび前記基準ファイバに機能可能に結合された発光ダイオードであり、前記グルコースファイバおよび前記基準ファイバに励起光を送る、発光ダイオードと、
前記グルコースファイバに機能可能に結合されたグルコース信号検出器であり、前記グルコースファイバから第1の蛍光を受け取る、グルコース信号検出器と、
前記基準ファイバに機能可能に結合された基準信号検出器であり、前記基準ファイバから第2の蛍光を受け取る、基準信号検出器と
を備えるセンサ。 - 前記第1のフルオロフォアが前記第2のフルオロフォアと同じである、請求項23に記載のセンサ。
- 前記第1のフルオロフォアが前記第2のフルオロフォアとは異なる、請求項23に記載のセンサ。
- 前記基準材料が消光剤を含む、請求項23に記載のセンサ。
- 前記基準材料が、グルコースを透過しない膜の中に入れられている、請求項23に記載のセンサ。
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US12/612,602 US8467843B2 (en) | 2009-11-04 | 2009-11-04 | Optical sensor configuration for ratiometric correction of blood glucose measurement |
US12/612,602 | 2009-11-04 | ||
PCT/US2010/044761 WO2011056274A1 (en) | 2009-11-04 | 2010-08-06 | Improved optical sensor configuration for ratiometric correction of blood glucose measurement |
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
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JP2021503985A (ja) * | 2017-11-21 | 2021-02-15 | サノフイSanofi | 埋込可能なグルコースモニタ |
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US8467843B2 (en) | 2013-06-18 |
US20130267802A1 (en) | 2013-10-10 |
US8700115B2 (en) | 2014-04-15 |
EP2496139A4 (en) | 2014-04-23 |
US20110105866A1 (en) | 2011-05-05 |
JP5767234B2 (ja) | 2015-08-19 |
EP2496139A1 (en) | 2012-09-12 |
WO2011056274A1 (en) | 2011-05-12 |
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