JP2001521171A - 測定された物理的パラメータの校正 - Google Patents

測定された物理的パラメータの校正

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JP2001521171A
JP2001521171A JP2000518278A JP2000518278A JP2001521171A JP 2001521171 A JP2001521171 A JP 2001521171A JP 2000518278 A JP2000518278 A JP 2000518278A JP 2000518278 A JP2000518278 A JP 2000518278A JP 2001521171 A JP2001521171 A JP 2001521171A
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ヘイノネン，ペッカ
オッコネン，ハーリ
ベルグ，ユッカ
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ノキア モービル フォーンズ リミティド
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Abstract

(57)【要約】 患者の血液サンプルの血糖レベルを測定するためのシステム。消耗試験ストリップ（５）が、該ストリップ（５）の製造バッチを特定するコード（７）と共に設けられる。測定ユニット（２）が設けられて移動電話機（１）に結合される。前記測定ユニット（２）は、試験ストリップ（５）を受け入れて、試薬（４）と血液サンプルとの反応に起因する該試薬（４）の色の変化を測定する。同時に前記識別コード（７）が前記測定ユニット（３）によって読まれて、前記移動電話機（１）によって、前記試験ストリップ製造業者により設けられた中央データベース（９）に送られる。前記データベース（９）は、識別コード（７）と、それと関連づけられた校正データとを含んでいる。識別コード（７）を受信すると、遠方のデータベース（９）は前記関連づけられた校正データを移動電話機（１）に送り、この移動電話機は該校正データを使用して、測定された色の変化から試験結果を計算する。この試験結果は前記電話機（１）のディスプレイで患者に表示されることができる。

Description

【発明の詳細な説明】
【０００１】 本発明は、測定装置に関し、特に測定プロセスにおいて消耗試薬を使用する測
定装置に関する。
【０００２】 測定プロセスの一部分として消耗試薬を使用する測定装置の例が多数ある。消
耗試薬は、一般に、化学的、生化学的、或いは生物学的性質のものである。その
様な装置の１例は、患者の血液サンプルのブドウ糖レベルを測定するように設計
されている血糖メーターである。少量の適当な試薬が、血糖メーターに挿入する
ことのできる細長いプラスチック・ストリップに印刷されるか、そうでなければ
デポジット（ｄｅｐｏｓｉｔ）される。このメーターは、活性の試薬と血液サン
プル中に存在するブドウ糖との反応に起因する、印刷されている試薬の色の変化
を検出する反射計測に基づく測定システムを含む。
【０００３】 患者が血糖測定値に基づいてインシュリン治療法を決定する血糖メーターの場
合には、メーターの精度が非常に重要であることが分かる。これはメーターの非
常に精密な校正を必要とする。メーターの最初の校正は、普通は製造中及びその
直後に実行され、校正データがメーターの永久メモリーに蓄積される。しかし、
この段階でのメーターの校正は、消耗試薬自体の特性の変化及び偏差、試薬及び
試験ストリップの製造工程での僅かな変化に起因して生じることのある偏差、温
度及び湿度等の環境要因、並びに時間の経過に伴う試薬の特性の変化を容易に補
償することはできない。
【０００４】 校正データが蓄積される機械で読むことのできるメモリーを血糖試験ストリッ
プに、或いはむしろその様な試験ストリップのパックに設けることが知られてい
る。試験ストリップの新しいパックが開かれるとき、その機械で読むことのでき
るメモリーがメーターによって読まれ、校正データが血糖メーターのメモリーに
ダウンロードされる。この様にして、メーターの校正で試薬の製造偏差を考慮に
入れることが可能となる。しかし、試験ストリップの各パケット（ｐａｃｋｅｔ
）に機械で読むことのできるメモリーを設けるのは、必要なハードウェアに関し
て、また製造工程中に該メモリーをプログラミングするのに必要な付加的時間に
関して、割合に高価であることが分かる。更に、時間の経過に伴う試薬の特性の
変化を補償することは依然として困難である。せいぜい、試薬の年齢が分かって
いる場合に限って、何らかのあらかじめ決められた基準に基づいて粗末な見積も
りをすることができるに過ぎない。この様な事情があるので、血糖試験ストリッ
プの製造業者は、試験ストリップを非常に限られた数を単位として供給し、試薬
の特性が所望の範囲内にとどまることを保証するために貯蔵及び寿命について厳
格な仕様を作る傾向がある。それらの仕様は、試薬の製造及び流通に関して規模
の経済に逆行しがちである。
【０００５】 これらの問題は、血糖試験ストリップに限定されなくて、消耗試薬が使用され
る他の分野にも等しく当てはまる。
【０００６】 本発明の第１の形態に従って測定システムが提供され、このシステムは： 識別コードに関連づけられた消耗試薬を使用して物理的パラメータを測定す
るための測定装置と； 自動電話応答手段と； 前記自動電話応答手段に結合されていて、消耗試薬識別コードの集合と、そ
れぞれの校正データとを含むデータベースと； 電話リンクを介して前記測定装置を前記自動電話応答手段に結合するための
手段とを含んでおり； 前記自動電話応答手段は、前記測定装置から前記電話リンクを介して送られ
た識別コードを受け取り、その後に前記データベースにアクセスして前記の送ら
れた識別コードに関連づけられた校正データを特定し、その特定された校正デー
タを前記測定装置に送るか又は特定された校正データを使用して試験結果を計算
してその試験結果を前記測定装置に送るようになっている。
【０００７】 特定の消耗試薬についての校正データを中央データベースに蓄積することによ
り、時間の経過に伴ってその消耗試薬に生じることのある変化を反映するように
該校正データを更新することが可能となる。更に、試薬と共に校正データを最終
消費者に供給することは最早不要である。これは製造プロセスを簡単化すると共
に、複雑な記憶手段を最終消費者に供給する必要を無くする。本発明の他の利点
は、消耗試薬を使用する測定装置により作成されたデータを中央データベースに
送ることができ、ここに多数の装置からの情報を収集して分析することができる
ことである。
【０００８】 本発明の１実施態様では、自動電話応答手段は、受け取った識別コードに関連
づけられた校正データを測定装置に送り返すようになっている。前記測定装置は
、受け取った校正データを使用して、前記の測定された物理的パラメータを処理
して試験結果を提供するデータ処理手段を含む。好ましくは、前記測定装置は、
その試験結果をユーザーに表示するためのディスプレイを含む。
【０００９】 本発明の代わりの実施態様では、測定装置は、前記の測定された物理的パラメ
ータを前記識別コードと共に自動電話応答手段に送るようになっている。システ
ムは、更にデータ処理手段を含んでおり、これは、該データベース及び自動電話
応答手段に結合され、特定された校正データと、受け取った物理的パラメータと
を使用して試験結果を計算する。自動電話応答手段は、例えば装置のディスプレ
イで表示させるために、その試験結果を測定装置に送り返す。この実施態様の利
点は、中央設備で提供され得る処理能力が割合に大きいので、割合に複雑なアル
ゴリズムを使用して試験結果を計算することが可能であることである。更に、そ
のアルゴリズムを容易に更新し、或いは修正することができる。
【００１０】 好ましくは、識別コードは、機械で読むことのできる形で消耗試薬に与えられ
る。例えば、該コードは、バーコード或いは固体メモリーに入れられる。測定装
置には、測定装置のメモリーに識別コードを読み込むことのできる読み取り機械
が設けられる。識別コードは、各々の消耗試薬に設けられても良く、或いはその
様なものの束に設けられても良い。消耗試薬が試験ストリップに付されている場
合、該コードをその試験ストリップの１つに、或いはダミー・ストリップに設け
ることができる。
【００１１】 代わりの実施態様では、識別コードは人間が読むことのできる形で設けられる
。測定装置は、ユーザーが識別コードを入力することを可能にするユーザーイン
ターフェースを含んでいる。例えば、そのユーザーインターフェースはキーパッ
ドである。
【００１２】 測定装置は、無線伝送チャネルを介して該測定装置をデータベースに結合する
ことのできる移動電話装置を含むことができる。該装置の測定ユニットは、前記
移動電話に統合され、或いはそれに接続されることができる。データは、前記移
動電話装置と前記自動電話応答手段との間でデータ呼を介して伝送されることが
できる。移動電話装置がＧＳＭシステムのディジタル電話装置である場合には、
ショートメッセージ・システム（ＳＭＳ）を使用してデータを伝送することがで
きる。
【００１３】 本発明は、例えば、患者の血液サンプルのブドウ糖レベルを測定するためのシ
ステムに応用可能である。
【００１４】 本発明の第２の形態に従って、識別コードと組み合わされている消耗試薬、又
は消耗試薬のパックが提供され、前記試薬は本発明の上記第１形態の測定システ
ムに用いられるものであり、前記識別コードは前記データベースに蓄積されてい
る校正データの集合を特定する。
【００１５】 好ましくは、本発明の第２形態の組み合わせは、前記識別コードを蓄積する機
械で読むことのできるメモリーを含む。そのメモリーは、バーコード、メモリー
チップ、磁性ストリップ、或いは他の適当な手段であって良い。
【００１６】 本発明の第３形態に従って、測定装置と消耗試薬とを使用して測定された物理
的パラメータから試験結果を引き出す方法が提供され、この方法は： 識別コードと共に消耗試薬を設け； 識別コードの集合とそれぞれの校正データとを含むデータベースを設け； 電話リンクを介して前記識別コードを前記測定装置から前記データベースに
伝送し； その伝送された識別コードの受信に自動的に応答して、前記データベース中
の対応する校正データを特定し、そのデータ、又はそのデータを使用して決定さ
れた試験結果を前記測定装置に送り返すことを含む。
【００１７】 好ましくは、前記電話リンクは移動電話リンクから成り、前記測定装置は移動
電話装置に結合される測定ユニットから成る。
【００１８】 本発明をさらに良く理解するために、また、本発明の実施方法を示すために、
例として添付図面を参照する。
【００１９】 糖尿病患者に血糖レベル試験結果を供給することのできるシステムが図１に示
されている。そのシステムは移動電話機１を含んでおり、この移動電話機は、図
１において裏面から示されていてキーボード及びディスプレイは見えない。この
電話機は、修正されているソフトウェアを含んでいるけれども、他の点では従来
のと同じである。しかし、従来のバッテリーの代わりに、普通はバッテリーが占
める移動電話機１の裏面のスロットに挿入することのできる測定ユニット２が設
けられている。測定ユニット２は、測定ユニット２及び電話機１に給電するため
の、小型化されたバッテリー・ユニット（図示されていない）を内蔵する。
【００２０】 測定ユニット２は、あらかじめ決められた基礎レベルに対する消耗試薬４の色
の変化を測定することのできる反射計システム３を内蔵している。消耗試薬４は
、細長い試験ストリップ５の表面領域に印刷され、或いはそうでなければデポジ
ットされる。試験ストリップ５は、測定ユニット２の側面に設けられていて反射
計システム３へのアクセスを提供するスロット６に挿入可能である。
【００２１】 消耗試薬４に加えて、試験ストリップ５には、その上面に印刷されたバーコー
ド７が設けられている。バーコード７は、試験ストリップ５の製造バッチ番号（
manufacturing batch number）を特定する識別コードを表している。測定ユニッ
ト２は、スロット６に位置合わせされている光学式読み取り装置を含んでおり、
それは、試験ストリップ５がスロット６に挿入されたときにバーコード７を読む
。この光学式読み取り装置は、測定ユニット２の独立した内部コンポーネントで
あっても良いけれども、好ましくは、少なくとも部分的に、反射計システム３に
より供給される。いずれの場合にも、読まれた識別コードは測定ユニット２また
は電話機１のメモリー８に蓄積される。
【００２２】 試験ストリップ５の製造業者又は販売業者は、試験ストリップ５の個々の製造
バッチを各々一義的に特定する識別コードの集合を内蔵する中央データベース９
を維持する。各識別コードに校正データの集合が関連づけられている。この校正
データは、典型的には、測定された色の変化を血糖レベルに関連づけるために使
用することのできるオフセット値と換算係数とを含んでいる（非線形校正データ
を設けることもできる）。試験ストリップのバッチのための校正データは、バッ
チの製造に続いて例えば典型的な測定ユニットを使って実験分析により実行され
た試験の結果を比較することによって、最初に決定される。しかし、校正データ
は、保持されている試験ストリップの蓄えから取り出されたサンプルを試験し直
すことにより、定期的に更新される。
【００２３】 自動電話応答装置１０は、製造業者（又は配給者）の構内に置かれ、電話回線
１１及びデータベース９の両方に結合される。この装置１０の動作について以降
に説明をする。
【００２４】 血糖試験を開始するために、患者は、電話のディスプレイに表示されたメニュ
ーを使って測定シーケンスを作動させる。患者は少量の血液を試薬４の上に置く
。短時間後に、試験ストリップ５はスロット６に完全に挿入される。挿入時に、
バーコード７が伝える識別コードが該ユニットのメモリー８に読み込まれる。そ
の後、試薬４の色の変化が反射計システム３によって測定されて、その結果もユ
ニットのメモリー８に読み込まれる。
【００２５】 その後、患者は、電話のディスプレイに表示されるメッセージにより、遠方の
自動電話応答装置１０へのデータ呼を起動するように促される。その促しをユー
ザーが受け入れると、電話機１は、セルラー電話ネットワーク１２での伝送チャ
ネルを開いて、読まれた識別コードを電話回線１１を介して自動電話応答装置１
０に送る。応答装置１０は、データベース９にアクセスして、受信された識別コ
ードに対応する校正データをそれからダウンロードすることによって応答する。
その後応答装置１０はその校正データをフォーマットし、セルラー・ネットワー
ク１２を介してそれを移動電話機１に送る。
【００２６】 電話機１に受信された校正データはメモリー８に蓄積される。その後、電話機
は、測定された色変化、受信された校正データ、及び測定ユニットのメモリー８
に予め蓄積されてあった計算アルゴリズムを使って血糖試験結果を計算する。こ
の計算は、電話機１の中央処理ユニット１３により実行される。
【００２７】 測定装置での測定プロセスに関連づけられた主なステップが図２の流れ図に示
されている。
【００２８】 測定された色変化を識別コードと共に測定ユニット２及び移動電話機１から遠
方のデータベース９に送ることによって同じ結果を得られることが分かる。この
ときデータベース９は校正データを使って測定値を処理して試験結果を作成する
ことができる。このとき、校正データを測定ユニット２に送る必要はなく、試験
結果を送るだけでよい。移動電話機１により受信された結果は該電話機のディス
プレイに直ぐに表示されることができる。
【００２９】 測定ユニットに最新の校正データを供給することに加えて、上記システムは他
の重要な利点を幾つか提供する。例えば、ユーザーが使用期限を過ぎた試験スト
リップを誤って使おうとしたならば、そのことをデータベース及び自動応答装置
がユーザーに知らせて測定を止めることができる。試験ストリップの使用パター
ンについての正確な記録をデータベースが保持することもできる。
【００３０】 本発明の範囲から逸脱せずに上記の実施態様を修正し得ることが分かる。例え
ば、上記実施態様は移動電話機を利用しているけれども、代わりの実施態様は陸
上電話機又は２方向ページャーを使用することができる。
【図面の簡単な説明】
【図１】 図１は本発明を実現する測定システムを示している。
【図２】 図２は図１のシステムにより実行される測定方法を示す流れ図である。
───────────────────────────────────────────────────── フロントページの続き (81)指定国 ＥＰ(ＡＴ，ＢＥ，ＣＨ，ＣＹ， ＤＥ，ＤＫ，ＥＳ，ＦＩ，ＦＲ，ＧＢ，ＧＲ，ＩＥ，Ｉ Ｔ，ＬＵ，ＭＣ，ＮＬ，ＰＴ，ＳＥ)，ＯＡ(ＢＦ，ＢＪ ，ＣＦ，ＣＧ，ＣＩ，ＣＭ，ＧＡ，ＧＮ，ＧＷ，ＭＬ， ＭＲ，ＮＥ，ＳＮ，ＴＤ，ＴＧ)，ＡＰ(ＧＨ，ＧＭ，Ｋ Ｅ，ＬＳ，ＭＷ，ＳＤ，ＳＺ，ＵＧ，ＺＷ)，ＥＡ(ＡＭ ，ＡＺ，ＢＹ，ＫＧ，ＫＺ，ＭＤ，ＲＵ，ＴＪ，ＴＭ) ，ＡＬ，ＡＭ，ＡＴ，ＡＵ，ＡＺ，ＢＡ，ＢＢ，ＢＧ， ＢＲ，ＢＹ，ＣＡ，ＣＨ，ＣＮ，ＣＵ，ＣＺ，ＤＥ，Ｄ Ｋ，ＥＥ，ＥＳ，ＦＩ，ＧＢ，ＧＤ，ＧＥ，ＧＨ，ＧＭ ，ＨＲ，ＨＵ，ＩＤ，ＩＬ，ＩＳ，ＪＰ，ＫＥ，ＫＧ， ＫＰ，ＫＲ，ＫＺ，ＬＣ，ＬＫ，ＬＲ，ＬＳ，ＬＴ，Ｌ Ｕ，ＬＶ，ＭＤ，ＭＧ，ＭＫ，ＭＮ，ＭＷ，ＭＸ，ＮＯ ，ＮＺ，ＰＬ，ＰＴ，ＲＯ，ＲＵ，ＳＤ，ＳＥ，ＳＧ， ＳＩ，ＳＫ，ＳＬ，ＴＪ，ＴＭ，ＴＲ，ＴＴ，ＵＡ，Ｕ Ｇ，ＵＳ，ＵＺ，ＶＮ，ＹＵ，ＺＷ (72)発明者 ベルグ，ユッカ フィンランド国，エフイーエン−90550 オウル，ペーホティエ １ Ｆターム(参考） 2G058 AA09 CE01 EA16 GA02 GB10 GC02 GC08 GD02 GD05 GD07 HA00

Claims (11)

    【特許請求の範囲】
  1. 【請求項１】 識別コード（７）に関連づけられた消耗試薬（４）を使用し
    て物理的パラメータを測定するための測定装置（１，２）と； 自動電話応答手段（１０）と； 該自動電話応答手段（１０）に結合されていて、消耗試薬識別コードの集合
    と、それぞれの校正データとを含むデータベース（９）と； 電話リンク（１１，１２）を介して前記測定装置を前記自動電話応答手段（
    １）に結合するための手段（１）とを含む測定システムであって； 前記自動電話応答手段（１０）が、前記測定装置（１，２）から前記電話リ
    ンク（１１，１２）を介して送られた識別コードを受け取り、その後に前記デー
    タベース（９）にアクセスして前記の送られた識別コードに関連づけられた校正
    データを特定し、その特定された校正データを前記測定装置（１，２）に送るか
    又は特定された校正データを使用して試験結果を計算してその試験結果を該測定
    装置（１，２）に送るように構成されている測定システム。
  2. 【請求項２】 前記自動電話応答手段（１０）が、受け取った識別コードに
    関連づけられた校正データを前記測定装置（１，２）に送り返すように構成され
    ており、また該測定装置（１，２）が、受け取った校正データを使用して、前記
    の測定された物理的パラメータを処理して試験結果を提供するデータ処理手段（
    １３）を含む、請求項１に記載のシステム。
  3. 【請求項３】 前記測定装置（１，２）が、前記測定された物理的パラメー
    タを前記識別コードと共に前記自動電話応答手段（１０）に送るように構成され
    ている、請求項１に記載のシステムであって、該システムは更にデータ処理手段
    （９）を含んでおり、このデータ処理手段が、前記特定された校正データと、受
    け取った物理的パラメータとを使用して試験結果を計算するために、前記データ
    ベース（９）及び前記自動電話応答手段（１０）に結合され、前記自動電話応答
    手段（１０）が、前記試験結果を前記測定装置（１，２）に送り返すように構成
    されているシステム。
  4. 【請求項４】 前記識別コードが前記消耗試薬（４）に機械で読むことので
    きる形で設けられている請求項１〜３のいずれか１項に記載のシステム。
  5. 【請求項５】 前記識別コード（７）がバーコード又は固体メモリーに入れ
    られ、前記測定装置（１，２）が、前記識別コードを前記測定装置（１，２）の
    メモリー（８）に読み込むことのできる読み取り機械（３）を備えている請求項
    ４に記載のシステム。
  6. 【請求項６】 前記測定装置（１，２）が、無線伝送チャネル（１２）を介
    して前記測定装置（１，２）を前記データベース（９）に接続することのできる
    移動電話装置（１）を含む請求項１〜５のいずれか１項に記載のシステム。
  7. 【請求項７】 前記測定装置（１，２）が、患者の血液サンプルのブドウ糖
    レベルの尺度を提供するように構成されている請求項１〜６のいずれか１項に記
    載のシステム。
  8. 【請求項８】 識別コード（７）と組み合わされている消耗試薬（４）、又
    は消耗試薬のパック、であって、前記試薬（４）が請求項１〜７のいずれか１項
    に記載の測定システムに用いられるものであり、前記識別コード（７）が前記デ
    ータベース（９）に蓄積されている校正データの集合を特定する消耗試薬（４）
    、又は消耗試薬のパック。
  9. 【請求項９】 機械で読むことのできるメモリーを含んでおり、このメモリ
    ーにより前記識別コード（７）が蓄積される請求項８に記載の組み合わせ。
  10. 【請求項１０】 測定装置及び消耗試薬を使用して測定された物理的パラメ
    ータから試験結果を引き出す方法であって、この方法は： 識別コードと共に消耗試薬を設け； 識別コードの集合と、それぞれの校正データとを含むデータベースを設け： 電話リンクを介して前記測定装置から前記データベースに前記識別コードを
    送り； 前記データベース中の対応する校正データを特定することにより送られた該
    識別コードの受信に自動的に応答し、そのデータ、又はそのデータから引き出さ
    れた試験結果を前記測定装置に送り返すことを含む方法。
  11. 【請求項１１】 前記電話リンクが移動電話リンクを含んでおり、前記測定
    装置が、移動電話装置に結合される測定ユニットを含む請求項１０に記載の方法
    。
JP2000518278A 1997-10-27 1998-09-22 測定された物理的パラメータの校正 Expired - Fee Related JP4243424B2 (ja)

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