JP4190417B2 - 無試薬全血ブドウ糖計 - Google Patents
無試薬全血ブドウ糖計 Download PDFInfo
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- JP4190417B2 JP4190417B2 JP2003541459A JP2003541459A JP4190417B2 JP 4190417 B2 JP4190417 B2 JP 4190417B2 JP 2003541459 A JP2003541459 A JP 2003541459A JP 2003541459 A JP2003541459 A JP 2003541459A JP 4190417 B2 JP4190417 B2 JP 4190417B2
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Description
<好ましい態様の詳細な記述>
或る好ましい実施態様及び実施例が下記で開示されるが、本発明は、特定の開示される実施態様を超えて、他の代替しうる実施態様及び/又は本発明の使用及びその明らかな変型と均等物まで及ぶことは当業者により理解されるであろう。かくして、ここに開示された本発明の範囲は下記説明の特定の開示された実施態様により限定されるべきでないものと意図されている。
本明細書で被検体検出システムが開示されるが、該システムは、主として下記パートAで論じられる非侵襲正システムと、主として下記パートBで論じられる全血システムと、を含んでいる。また、材料サンプル内の被検体の濃度を検出する方法を含む種々の方法が開示される。該非侵襲性システム/方法と該全血システム/方法はそれらが共に光学的測定を使うことで関連付けられる。測定の装置と方法を参照して本明細書で使われる時、「光学的」は広い用語であり、その普通の意味で使われ、限定が無い場合は、化学反応を起こす必要無しに物質サンプル内の被検体の存在又は濃度の識別を意味する。下記でより詳細に論じる時、該2つの取り組みは材料サンプルの光学的分析を行うため各々独立に動作することが出来る。また、該2つの取り組み1つの装置内で組み合わされることも可能であり、該2つの取り組みは方法の種々の過程を行うために一緒に使われることも可能である。
A.非侵襲性システム
1.モニター構造体
図1は現在の好ましい実施態様の非侵襲性光学的検出システム{以下「非侵襲性システム」と記す}10を描いている。該描かれた非侵襲性システム10は、下記で更に詳細に論じる様に、サンプルにより放射される赤外線エネルギーを観察することにより、材料サンプルS内の被検体の濃度を非侵襲的に検出するために特に好適である。
窓組立体12の好ましい外形はその下側から見た時の斜視図として図2に示されている。該窓組立体12は一般に、高い赤外線透過性の材料から形成される主層(main layer)32と該主層32の下側に固定されたヒーター層34とを有する。該主層32は約0.25mmの好ましい厚さの、好ましくはダイヤモンドから、最も好ましくは化学蒸着された{”シーブイデー(CVD)”}ダイヤモンドから形成されるのがよい。他の実施態様では、シリコン又はゲルマニウムの様な、高赤外線透過性である、代わりの材料が該主層32の形成で使用されてもよい。
該冷却システム14(図1参照)は好ましくはペルチエ型熱電デバイス(Peltier−type thermoelectric device)を有するのがよい。かくして、該好ましい冷却システム14への電流の印加は該冷たい面14aを冷えさせそしてその相対する熱い面14bを暖まらせる。該冷却システム14は該冷却システム14の冷たい面14aと熱伝導関係にある該窓組立体12の状況を介して該窓組立体12を冷却する。好ましくは、該コールドリザーバー(cold reservoir)16が該冷却システム14と該窓組立体12の間に位置付けられ、該システム14と該窓組立体12の間の熱伝導体として機能するのがよい。該コールドリザーバー16は適当な熱伝導性材料、好ましくは黄銅から形成されるのがよい。代わりに、該窓組立体12は該冷却システム14の冷たい面14aと直接接触して位置付けられることも出来る。
図1に示す様に、該光学的ミキサー20は、赤外線波長で高度に反射性でそして最小の吸収性の内面コーテイング、好ましくはポリッシされた金のコーテイング、を有するライトパイプを備える。該パイプ自身は、該内面が高度に反射性であるようコートされるか又は他の仕方で処理される限り、アルミニウム又はステンレス鋼の様なもう1つの堅い材料で作られてもよい。他の多角形の形状又は円形又は楕円形の形状の様な、他の断面形状も代わりの実施態様で使われてもよいが、好ましくは該光学的ミキサー20は長方形の断面を有するのがよい(該ミキサー20とコリメーター22の縦軸線A−Aに対し直交して取られる時)。該光学的ミキサー20の内壁は該ミキサー20と該コリメーター22の縦軸線A−Aに実質的に平行である。該ミキサー20の高度に反射性で実質的に平行な内壁は該赤外線エネルギーEが該ミキサー220の該壁間で反射される回数を最大化し、それが該ミキサー20を通って伝播する時該赤外線エネルギーEを徹底して混合する。現在の好ましい実施態様では、該ミキサー20は長さが約30.48mm(約1.2インチ)から60.96mm(約2.4インチ)であり、その断面は約10.16mm(約0.4インチ)×15.24mm(約0.6インチ)の長方形である。勿論、該ミキサー20を作る際他の寸法が使われてもよい。
フイルター24は、カリフオルニア州、サンタローザ(Santa Rosa, CA)のオプチカルコテイングラボラトリー社(Optical Coating Laboratory, Inc.){”オーシーエルアイ(OCLI)”}の様な製造者から広く入手可能な、標準的干渉型赤外線フイルターを含む。図1に図解する実施態様では、フイルター24の3×4配列が検出器28と集中器26の3×4配列の上に位置付けられる。この実施態様で使われる時、該フイルター24は同じ波長感度を有する3つのフイルターの4つのグループで配置される。これら4つのグループはそれぞれ、7.15μm±0.03μm、8.40μm±0.03μm、9.48μm±0.04μm、そして11.10μm±0.04μmのバンドパス中心波長を有するが、該波長は水及びブドウ糖が付近で電磁放射を吸収する波長に対応する。これらのフイルター用の典型的バンド幅は0.20μmから0.50μmに及ぶ。
検出器28は、好ましくは中央部赤外線波長(mid−infrared wavelengths)の、赤外線エネルギーを検出用に好適な何れかの検出器の種類を具備するのがよい。例えば、該検出器28は水銀−カドミウム−テルル化物(mercury−cadmium−telluride){エムシーテー(MCT)}検出器を具備するのがよい。ピーブイエイ481−1前置増幅器(PVA481−1 preamplifier)を有するフアーミオニクス(Fermionics){シミバレー、カリフオルニア(Simi Valley, Calif)}モデルピーブイ−9.1(model PV−9.1)の様な検出器が採用可能である。グレーズビー(Graseby){タンパ、フロリダ州(Tampa,Fla)}の様な他の製造者からの同様なユニットが交換され得る。該検出器28としての使用のための他の適当な部品はパイロ電気的検出器(pyroelectric detectors)、サーモパイル(thermopiles)、ボロメーター(bolometers)、シリコンマイクロボロメーター(silicon microbolometers)そしてレッドソールトフオーカルプレーンアレー(lead−salt focal plane arrays)を含む。
図7は制御システムと該非侵襲性システムの他の関係部分との間の相互接続のみならずより詳細な制御システム30を描く。該制御システムは温度制御サブシステムとデータ取得サブシステムを含む。
該非侵襲性システム10の検出器(複数を含む)28は種々の望ましい波長で材料サンプルSにより放射される赤外線エネルギーを検出するため使用される。各測定される波長で、該材料サンプルSは時間に亘り変化する強度で赤外線エネルギーを放射する。該時間変化する強度は、該材料サンプルS内に熱的勾配を誘起するよう該窓組立体12(そのヒーター層34を含めて)及び該冷却システム14の使用に応答して主に起こる。ここで使用される時、「熱的勾配」は広い用語であり、その普通の意味で使用され、限定無き場合は、材料サンプルの、異なる深さの様な、異なる位置間の温度差を称する。下記で詳細に論じられる様に、材料サンプルS内の(ブドウ糖の様な)関心のある被検体の濃度は、種々の測定された波長の時間変化する強度プロフアイルを比較することにより、該非侵襲性システム10の様なデバイスで決定出来る。
図8に更に示す様に、信号強度P、Q、Rは初期に正規化されたベースライン信号強度1で示される。これは勿論印加される加熱又は冷却の無い場合の試験サンプルのベースライン放射動作を反映する。時刻tCで、該サンプルの表面は該サンプル内に熱的勾配を誘起する温度イベントに供される。該勾配は該サンプル表面を加熱又は冷却することにより誘起される。図8に示す例は、例えば10℃冷却イベントを使用して、冷却を使用する。該冷却イベントに応答して、検出器信号の強度P、Q、Rは時間上で減少する。
この位相差の大きさは増加する被検体濃度と共に減少する。
この位相差の大きさは増加する被検体濃度と共に増加する。
を選ぶこと、そして各チェック点で観察される位相差を平均化すること、により高められる。この方法の精度は更に試験時間全体上で連続的に該位相差(複数を含む)を積分することにより高められる。この例では唯1つの温度イベント(ここでは、冷却イベント)が誘起されたので、該サンプルは新しいより低い平衡温度に達し、信号は新しい一定レベルIFで安定する。勿論、該方法は、加熱により、或いは、それらに限定されないが、光、放射、化学的に誘起された熱、摩擦そして振動の様な他の形式のエネルギーの印加、又は導入により、誘起される熱的勾配でも等しく良く動作する。
上記説明の方法論の変型では、被検体濃度の精密な決定を行うため周期的に変調された熱的勾配が使われ得る。
B.全血検出システム
図13は現在の好ましい構成の無試薬全血被検体検出システム200{以下「全血システム」}の略図である。該全血システム200は放射源20と、フイルター230と、サンプルセル242を有するキュベット240と、そして放射検出器250とを備える。又該全血システム200は好ましくはシグナルプロセッサー260とデイスプレー270を有するのがよい。キュベット240がここで示されるが、下記で説明する様に、他のサンプル要素も又該システム200で使用出来る。又該全血システム200はサンプル抽出器280を有するが、それは指290の様な、外肢(appendage)からの体液にアクセスするため使用出来る。
A.検出システム
図18は、下記で詳述されることを除くと、全血システム200と同様である無試薬全血被検体検出システム400の略図を示す。該全血システム400は患者近傍で使用されるよう構成され得る。患者近傍で使用されるよう構成された一つの実施態様は患者近傍型、又はポイントオブケア試験システムである。この様なシステムは、患者又は医者への便利さ、使用の容易さ、そして行われる分析の比較的低いコストを含めて、より複雑な実験室システムに優る幾つかの利点を提供する。
B.利点と他の使用法
本明細書で説明された該全血システムは既に上記で論じられたものに加えて、幾つかの利点と使用法を有する。ここで説明された該全血システムは、それらが関心のある被検体を光学的に測定するので、非常に精密である。又、該全血システムの精度は多数の血液サンプルを抜き取る必要無しに更に改善出来る。試薬ベースの技術では、血液サンプルは試験ストリップ上の試薬に接触するようもたらされ、指示された化学反応が起こり、そしてその反応の或る側面が観察される。該反応をホストする試験ストリップは限られた量の試薬を有するのみで、限られた量の血液に適応するのみである。結果として、試薬ベースの分析技術は1つの測定に対応する試験ストリップ当たり1つの反応のみを観察する。試薬ベースの技術の精度を改良する第二の対策を行うために、第二の試験ストリップが用意されねばならず、それは患者から血液の第二の抜き取りを要する。対照的に、ここに説明された全血システムはサンプルの入射放射に対する応答を光学的に観察する。この観察は患者から抜き取られた各血液サンプルについて多数回行い得る。
Claims (17)
- 放射のビームを放つことが出来る変調された源;
該ビームの光路内の検出器;
該検出器と連絡している同期復調器;
該源と該検出器を収納するように、大きさが作られ且つ構成された、ハウジング;
サンプル要素が容器中に置かれた時に該サンプル要素の少なくとも一部が光路中に置かれるように大きさが作られ且つ構成された、該サンプル要素を手動で受け入れるためにハウジング内に形成された容器;および
該ハウジングの該容器中で取りはずし可能に置かれており、且つ少なくとも一部は該放射が通過できる材料から作られている、使い捨てできるサンプル要素、ここで該サンプル要素は、
無視できないスペクトルバンドの吸収を有するサンプルセル壁;および
光学測定を複雑化し得る血液成分が分離された血液サンプルで少なくとも一部は満たされるように構成されたサンプルセル;
を含んで成り;
更に、放射の該スペクトルバンドを透過するよう構成されている、該ビームの該光路内のフィルタリングシステムを含んでおり;
ここで、該フィルタリングするシステムは以下の中心波長:約5.25μm、約6.12μm、約7.4μm、約8.0μm、約8.45μm、約9.25μm、約9.65μm、10.4μm、約12.2μm、の少なくとも1つにおいて放射を透過するよう構成されている、
患者近傍で展開され得る、無試薬グルコース検出システム。 - フィルタリングシステムが、複数のスペクトルバンドおよび複数の波長から成る群から選択される一方を透過するように作られている、請求項1に記載の検出システム。
- フィルタリングシステムが軸線の周りを回転可能である、請求項1に記載の検出システム。
- サンプル要素が、更に開口部とサンプル供給通路を含んで成り、該サンプル供給通路が該開口部と該サンプルセルの間に延びている、請求項1に記載の検出システム。
- ハウジングが、患者の手のひらまたはポケットに収まるに十分小さいように大きさが作られ且つ構成された、請求項1に記載の検出システム。
- 放射が通過できる材料が、ポリエチレンおよびポリプロピレンから成る群から選択される、請求項1に記載の検出システム。
- サンプルセルが変調された源から放たれた放射のビームの光路に置かれた時に、サンプル要素の少なくとも一部がハウジングから延びる、請求項1に記載の検出システム。
- 変調された源が第一及び第二の放射のビームを放つことができ、サンプルセルが第一のビームの光路に置かれ、サンプル要素の第二の部分が第二のビームの光路に置かれている、請求項1に記載の検出システム。
- サンプル要素の第二の部分が、ポリエチレンおよびポリプロピレンから成る群から選択される材料から作られている校正部分である、請求項8に記載の検出システム。
- (i)中心波長を有するスペクトルバンドを含む放射の被検体ビーム、および(ii)放射の校正ビーム、を放つことができる変調された源;
被検体ビームの光路にある検出器;
検出器と連絡した同期非変調器;
被検体ビームと校正ビームに対応するシグナルを比較するように構成された、検出器と連絡したプロセッサー;
源および検出器を収容するように作られたハウジング;
光学測定を複雑化し得る血液成分が分離された血液サンプルで満たされるように作られ、
スペクトルバンドの放射の無視できない吸収を有するサンプルセル壁;および
サンプルセル;
を含む、被検体ビームの光路および校正ビームの光路に置かれた使い捨てできるサンプル要素;
および
以下の中心波長:約5.25μm、約6.12μm、約7.4μm、約8.0μm、約8.45μm、約9.25μm、約9.65μm、約10.4μm、約12.2μm、の少なくとも1つの放射を透過するように構成された、被検体ビームの光路のフィルタリングシステム、
を含んで成る、患者近傍で展開され得る無試薬被検体検出システム。 - フィルタリングシステムが、複数のスペクトルバンドおよび複数の波長から成る群から選択される一方を透過するように作られている、請求項10に記載の無試薬被検体検出システム。
- 放射の被検体ビームの光路が、放射の校正ビームの光路から間隔をおいてある、請求項10に記載の無試薬被検体検出システム。
- サンプルセルが校正部分を含んでなり、校正部分が校正ビームの光路に沿って置かれる時にサンプルセルが被検体ビームの光路に沿って置かれるように大きさが作られ且つ構成されている、請求項10に記載の無試薬被検体検出システム。
- 校正部分が第一の材料から作られた校正部分壁を含んでなり、そしてサンプルセル壁が第二の材料から作られている、請求項13に記載の無試薬被検体検出システム。
- 校正部分壁の厚さとサンプルセル壁の厚さがほぼ同じであり、第一の材料と第二の材料がほぼ同じ透過特性を有する、請求項14に記載の無試薬被検体検出システム。
- 校正部分が校正窓を含んでなり、サンプルセル壁が複数のサンプル窓をふくんでなる、請求項14に記載の無試薬被検体検出システム。
- サンプル要素が更にサンプルセルから延びる通路を含んでなり、該通路が流体をサンプルセルに運ぶのに適合されている、請求項10に記載の無試薬被検体検出システム。
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-
2002
- 2002-07-19 US US10/200,384 patent/US7050157B2/en not_active Expired - Lifetime
- 2002-11-06 EP EP02802869A patent/EP1450677B1/en not_active Expired - Lifetime
- 2002-11-06 JP JP2003541459A patent/JP4190417B2/ja not_active Expired - Fee Related
- 2002-11-06 AT AT02802869T patent/ATE315907T1/de not_active IP Right Cessation
- 2002-11-06 CA CA002465889A patent/CA2465889C/en not_active Expired - Lifetime
- 2002-11-06 AU AU2002356913A patent/AU2002356913B2/en not_active Ceased
- 2002-11-06 WO PCT/US2002/035707 patent/WO2003039362A1/en active IP Right Grant
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Also Published As
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ATE315907T1 (de) | 2006-02-15 |
EP1450677A1 (en) | 2004-09-01 |
DE60208825T2 (de) | 2006-09-14 |
JP2005508007A (ja) | 2005-03-24 |
AU2002356913B2 (en) | 2006-09-28 |
CA2465889C (en) | 2009-06-02 |
CA2465889A1 (en) | 2003-05-15 |
WO2003039362A1 (en) | 2003-05-15 |
US7050157B2 (en) | 2006-05-23 |
US20030086073A1 (en) | 2003-05-08 |
DE60208825D1 (de) | 2006-04-06 |
EP1450677B1 (en) | 2006-01-18 |
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