JP4632370B2 - 一体診断検査システム - Google Patents
一体診断検査システム Download PDFInfo
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- JP4632370B2 JP4632370B2 JP2006547208A JP2006547208A JP4632370B2 JP 4632370 B2 JP4632370 B2 JP 4632370B2 JP 2006547208 A JP2006547208 A JP 2006547208A JP 2006547208 A JP2006547208 A JP 2006547208A JP 4632370 B2 JP4632370 B2 JP 4632370B2
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- A61B5/150007—Details
- A61B5/150801—Means for facilitating use, e.g. by people with impaired vision; means for indicating when used correctly or incorrectly; means for alarming
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Description
診断検査を実行するため、ユーザは、まず、検査ストリップ等のサンプルの検査媒体を容器から取り出し、サンプリング装置を使用して(たとえば、ランセットを使用して血液を抜き出すことにより)サンプルを準備した後、更にそのサンプルを(検査媒体を計器のインターフェース部に挿し込む前又は後に)検査媒体に付着させなければならない。計器によりサンプルについて診断検査が実行され、その結果がユーザに対して数値等により表示される。
以上で述べた一般的な説明及び以下で述べる具体的な説明は、いずれも例示及び説明のためだけのものであり、請求の範囲のように本発明を限定するものではないことが理解される。
1.一体システム
図1は、本発明の例示的な実施の形態に従って診断検査を実行するための一体システム100を示している。一実施形態に係る一体システム100は、検査ストリップ120等の検査媒体を収容するための容器110と、容器110に収容されている検査ストリップ120を使用して診断検査を実行するための計器130とを備えている。
一体システム100において、ユーザが検査のためのサンプルを取得する際に使用することのできるサンプリング装置が更に設けられてもよい。このサンプリング装置は、生物的サンプルを取得するのに適合させることができる。サンプリング装置は、たとえば、ユーザが血糖レベルの診断検査のための血液を抜き出すのに使用するランシング(lancing)装置である。
2.計器電子回路
図4は、本実施形態に係る計器130の機能的コンポーネントを示すブロック図である。図4に示すように、計器130は、コントローラ400と、媒体インターフェース410と、電源420と、ユーザ制御部430と、入出力部440と、インジケータ450と、媒体分配機構460と、音声メッセージ部470と、環境センサ480とを有している。本実施形態において、計器130の機能的コンポーネントは、ハウジング131に収容される。しかしながら、与えられた機能のうちの幾つか又は全ては、一体システム100のどこにでも配置することが可能である。
図5は、媒体分配機構460を備える例示の一体システムの断面を示している。本実施形態において、容器は、スプリングロードマガジン510として構成される。マガジン510において、複数の検査ストリップ120が上下に積み重ねられている。このスタックの配列を維持するため、マガジン510に、検査媒体のものと同様の内部形状を持たせることができる。たとえば、図1に示す検査媒体について、マガジン510の内部を断面で略矩形とする。
3.誤った検査ストリップの使用の防止
計器130は、特定のブランド又は製造業者のロットの検査媒体との使用のため、計器130により実行される診断検査を、1以上の校正パラメータを使用して特定のブランド又はロットに関してカスタマイズすることにより、校正することができる。これらの校正パラメータには、コントローラ400の診断検査機能を特定のブランド又はロットの検査媒体に対してカスタマイズする、環境補正値(たとえば、温度補正値)、(たとえば、潜伏期間に関する)時期補正値、(たとえば、電気化学法により検査で使用される)電圧補正値、(たとえば、測光法による検査で使用される)色彩バリエーション等が含まれる(以上で参照により組み込まれた第10/286648号及び第10/420995号の出願を参照)。
Claims (40)
- 診断検査のためのシステムであって、
検査媒体に用いられたサンプルについて診断検査を実行するための計器と、
前記計器と適合する複数の検査媒体と、
前記複数の検査媒体を個々にばらけた状態で収容する容器と、
を含んで構成され、
前記計器は、
前記診断検査を実行する際に検査媒体を受けるためのインターフェースと、
前記診断検査を実行するように構成されたコントローラと、
前記診断検査の結果を表示するためのインジケータと、
前記複数の検査媒体を収容する前記容器の内部空間への開口であって、前記検査媒体が前記診断検査のために前記容器の内部空間から前記インターフェースへと移送される際に通過する開口を選択的に閉塞させるためのクロージャ部と、
前記クロージャ部と結合し、前記インターフェース、前記コントローラ及び前記インジケータを収容するように構成されたハウジングと、
を含んで構成されるシステム。 - 前記診断検査が生物的サンプルの分析のためのものである請求項1に記載のシステム。
- 前記診断検査がグルコース、ケトン、コレステロール、ヒト柔毛膜性ゴナドトロピン、ヘモグロビンA1C、フラクトサミン、含水炭素、腫瘍マーカ、鉛、抗てんかん薬、ビリルビン、肝機能マーカ、トキシン又はその代謝産物、調節物質、及び血液凝固因子のうちいずれかの存在、濃度又は量の判定のためのものである請求項2に記載のシステム。
- 前記診断検査において、測光法、反射、透過、拡散、吸収、蛍光、電気化学発光法、電気化学法、電量分析、電流測定及び電位差測定のうち少なくとも1つを含む方法が採用される請求項1に記載のシステム。
- 前記計器がハウジングを更に含んで構成され、
前記クロージャ部がこのハウジングに取り付けられるか、又は一体である請求項1に記載のシステム。 - 前記容器に収容された検査媒体を更に含んで構成され、
前記計器が、前記容器に収容された検査媒体に用いられたサンプルについて前記診断検査を実行するように構成された請求項1に記載のシステム。 - 前記計器が、前記容器に収容された検査媒体との使用のために校正される請求項6に記載のシステム。
- 前記クロージャ部が、前記開口を液体、蒸気及び空気のうち少なくとも1つの浸透に対してシールするように構成された請求項1に記載のシステム。
- 前記クロージャ部がプレスフィットクロージャ、ツイストオフクロージャ及びチャイルドプルーフクロージャのうち1つを含んで構成される請求項1に記載のシステム。
- 前記計器が柔軟なコネクタにより前記容器と接続された請求項1に記載のシステム。
- 前記柔軟なコネクタがヒンジである請求項10に記載のシステム。
- 前記容器に対して操作可能に接続されたサンプリング装置を更に含んで構成される請求項1に記載のシステム。
- 前記サンプリング装置がランセットである請求項12に記載のシステム。
- 前記ランセットが、これを前進させて皮膚を開通させるためのスプリングを含んで構成され、ユーザがこのスプリングに負荷をかけ、解放することにより前記ランセットを容器から取り外すことなくサンプルを抜き出すことができるように、前記容器に対して操作可能に接続された請求項13に記載のシステム。
- 前記ランセットが、その挿入の深さを調整するための機構を含んで構成され、ユーザがこの機構を操作して、前記ランセットを前記容器から取り外すことなく前記ランセットの挿入の深さを調整することができるように、前記容器に対して操作可能に接続された請求項13に記載のシステム。
- 前記計器の機能を制御するためのユーザ制御部を更に含んで構成される請求項1に記載のシステム。
- 前記ユーザ制御部が前記計器の側面にボタンを有し、
前記インジケータが前記計器の上面にディスプレイを有する請求項16に記載のシステム。 - 前記容器から検査媒体を分配するための媒体分配機構を更に含んで構成される請求項1に記載のシステム。
- 前記媒体分配機構が、検査媒体を前記インターフェース内に分配するように構成された請求項18に記載のシステム。
- 手に収まるように構成された請求項1に記載のシステム。
- 期間、日付、診断検査の範囲及び診断検査用の媒体の数量のうち少なくとも1つに相当するデータを更に含んで構成され、
前記コントローラが、前記データを点検して、トリガリングイベントが発生したかを判定し、トリガリングイベントが発生したと判定したときに、前記計器の機能を無効にするように構成された請求項1に記載のシステム。 - 電源を更に含んで構成され、
前記コントローラが、トリガリングイベントが発生したと判定したときに、前記電源を無効にするように構成された請求項21に記載のシステム。 - 前記コントローラが、前記電源にかかる負荷を増大させて前記電源をドレーンすることにより前記電源を無効にするように構成された請求項22に記載のシステム。
- 前記計器がクロックを更に含んで構成され、
前記コントローラが、前記クロックの周波数を増大させることにより前記電源にかかる負荷を増大させるように構成された請求項23に記載のシステム。 - 前記コントローラが、前記電源を遮断することにより前記電源を無効にするように構成された請求項22に記載のシステム。
- 前記コントローラが、前記インターフェースへの検査媒体の挿入をもって診断検査を開始するための自動オン機能を有し、トリガリングイベントが発生したときに、前記自動オン機能を無効にするように構成された請求項21に記載のシステム。
- 前記コントローラが、トリガリングイベントが発生したと判定したときに、前記計器の診断検査機能を無効にするとともに、前記計器を新たな機能を実行するように再構成するように構成された請求項21に記載のシステム。
- 前記コントローラが、前記インターフェースへの検査媒体の挿入をもって診断検査を開始するための自動オン機能を有し、この自動オン機能を無効にすることにより前記診断検査機能を無効にするように構成された請求項27に記載のシステム。
- 前記コントローラが、前記インジケータが診断検査の結果を表示するのを禁止することにより前記診断検査機能を無効にするように構成された請求項27に記載のシステム。
- 前記コントローラが、前記インジケータに診断検査の結果以外の情報を表示させることにより前記計器の機能を再構成するように構成された請求項27に記載のシステム。
- 前記診断検査の結果以外の情報が時刻、日付、温度、湿度、及び環境センサの読取値のうち少なくとも1つである請求項30に記載のシステム。
- 前記計器が少なくとも1つのユーザ制御部を更に含んで構成され、
前記コントローラが、前記少なくとも1つのユーザ制御部の機能を再構成することにより前記計器の機能を再構成するように構成された請求項27に記載のシステム。 - 前記容器に収容された検査媒体を更に含んで構成され、
前記データが、前記容器に収容された前記検査媒体と関連付けられた請求項21に記載のシステム。 - 前記トリガリングイベントが、前記容器に収容された前記検査媒体の満期日及び数量のうち一方と関連付けられた請求項33に記載のシステム。
- 前記トリガリングイベントが前記期間の終結、前記日付の経過、前記範囲の診断検査の達成及び前記数量の検査媒体の使用のうちいずれかと関連付けられた請求項21に記載のシステム。
- 前記トリガリングイベントが、前記計器の作動の最初の使用日、及び前記計器の作動の関連する複数の検査ストリップとの最初の使用日のうちいずれかに対する前記期間の終結と関連付けられた請求項35に記載のシステム。
- 前記計器の作動が診断検査の実行である請求項36に記載のシステム。
- 検査媒体に用いられたサンプルについて診断検査を実行するための計器であって、
前記診断検査を実行する際に検査媒体を受けるためのインターフェースと、
前記診断検査を実行するように構成されたコントローラと、
前記診断検査の結果を表示するためのインジケータと、
この計器と適合する複数の検査媒体を個々にばらけた状態で収容するように構成された容器の内部空間への開口であって、前記検査媒体が前記診断検査のために前記容器の内部空間から前記インターフェースへと移送される際に通過する開口を選択的に閉塞させるためのクロージャ部と、
前記クロージャ部に結合し、前記インターフェース、前記コントローラ及び前記インジケータを収容するように構成されたハウジングと、
を含んで構成される計器。 - 検査媒体に用いられたサンプルについて診断検査を実行する計器であって、
前記診断検査を実行する際に検査媒体を受けるためのインターフェースと、
前記診断検査を実行するように構成されたコントローラと、
前記診断検査の結果を表示するためのインジケータと、
前記インターフェース、前記コントローラ及び前記インジケータを収容するハウジングと、
を含んで構成され、
前記ハウジングは、この計器と適合する複数の検査媒体を個々にばらけた状態で収容するように構成された容器の内部空間への開口であって、前記検査媒体が前記診断検査のために前記容器の内部空間から前記インターフェースへと移送される際に通過する開口を選択的に閉塞させるためのクロージャ部に結合する部分を有する計器。 - 前記ランセットが、その挿入の深さを調整するための機構を含んで構成され、前記容器に対し、ユーザがこの機構を操作して前記ランセットの挿入の深さを調整することができるように操作可能に接続された請求項13に記載のシステム。
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-
2004
- 2004-06-02 US US10/857,917 patent/US8147426B2/en active Active
- 2004-12-20 TW TW093139589A patent/TWI375032B/zh active
- 2004-12-21 WO PCT/US2004/042724 patent/WO2005065539A1/en active Application Filing
- 2004-12-21 DK DK04814860.5T patent/DK1706024T3/da active
- 2004-12-21 PT PT04814860T patent/PT1706024E/pt unknown
- 2004-12-21 AU AU2004312027A patent/AU2004312027B2/en active Active
- 2004-12-21 BR BRPI0418216-2A patent/BRPI0418216B1/pt active IP Right Grant
- 2004-12-21 AT AT04814860T patent/ATE553694T1/de active
- 2004-12-21 ES ES04814860T patent/ES2386284T3/es active Active
- 2004-12-21 EP EP10180519.0A patent/EP2275023B1/en active Active
- 2004-12-21 SI SI200431895T patent/SI1706024T1/sl unknown
- 2004-12-21 EP EP19157992.9A patent/EP3524141A1/en not_active Withdrawn
- 2004-12-21 EP EP04814860A patent/EP1706024B1/en active Active
- 2004-12-21 JP JP2006547208A patent/JP4632370B2/ja active Active
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2010
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Also Published As
Publication number | Publication date |
---|---|
WO2005065539A1 (en) | 2005-07-21 |
ES2386284T3 (es) | 2012-08-16 |
AU2004312027B2 (en) | 2010-11-11 |
NO20063123L (no) | 2006-10-02 |
EP2275023A2 (en) | 2011-01-19 |
JP2007520699A (ja) | 2007-07-26 |
AU2011200574A1 (en) | 2011-03-03 |
JP2010279701A (ja) | 2010-12-16 |
AU2004312027A1 (en) | 2005-07-21 |
TWI375032B (en) | 2012-10-21 |
EP3524141A1 (en) | 2019-08-14 |
TW200530584A (en) | 2005-09-16 |
DK1706024T3 (da) | 2012-08-13 |
SI1706024T1 (sl) | 2012-09-28 |
EP1706024A1 (en) | 2006-10-04 |
US8147426B2 (en) | 2012-04-03 |
EP2275023A3 (en) | 2011-11-30 |
ATE553694T1 (de) | 2012-05-15 |
BRPI0418216B1 (pt) | 2022-06-14 |
EP2275023B1 (en) | 2019-02-20 |
US20050143675A1 (en) | 2005-06-30 |
PT1706024E (pt) | 2012-07-23 |
JP2014089192A (ja) | 2014-05-15 |
EP1706024B1 (en) | 2012-04-18 |
PL1706024T3 (pl) | 2012-09-28 |
BRPI0418216A (pt) | 2007-04-27 |
JP5535777B2 (ja) | 2014-07-02 |
JP6000230B2 (ja) | 2016-09-28 |
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