JP2010530790A - 健康管理装置および方法 - Google Patents
健康管理装置および方法 Download PDFInfo
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- G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
Abstract
Description
従って、ユーザが1つ以上の検体のためにテストすることを可能にする装置が関心を集めている。
従って、実施形態は、グルコース、乳酸塩などのような体液中の検体の生体内検出のために、少なくとも一部がユーザの皮膚の下に配置可能な検体センサを有する検体監視装置およびシステムを含む。実施形態は、全体が埋め込み可能な検体センサ、および、センサの一部だけが皮膚の下に位置し、センサの別の一部が発信器、送信器、受信器、送受信プロセッサなどとのコンタクトのために皮膚の上部に存在する検体センサを有する。センサは、例えば患者の間質液中の検体のレベルの連続的または周期的なモニタリングのために、患者の皮下に配置できる。この記述の目的のために、そうではないと断りがない限り、連続モニタリングと周期的モニタリングとは互いに入替え可能に使用される。
約1時間またはそれ以上、例えば約数時間またはそれ以上、例えば約数日またはそれ以上、例えば3日またはそれ以上、例えば5日またはそれ以上、例えば約7日またはそれ以上、例えば数週間または少なくとも1ヶ月にわたって、検体の生体内検出ができるグルコース・センサのような検体センサが関心を持たれている。将来の検体レベルを、得られた情報、例えば現在の時刻toの検体レベルと検体の変化率などに基づいて予測してもよい。予測的なアラームで、ユーザの検体レベルが将来の検体レベルに達する以前に、懸念される予測検体レベルをユーザに通知してもよい。これは、ユーザに是正処置をとる機会を与える。
モニタされる検体には、アセチル・コリン、アミラーゼ、ビリルビン、コレステロール、絨毛性ゴナドトロピン、クレアチンキナーゼ(例えばCK−MB)、クレアチン、クレアチニン、DNA、フルクトサミン、グルコース、グルタミン、成長ホルモン、ホルモン、ケトン体、乳酸塩、過酸化物、前立腺特異抗原、プロトロンビン、RNA、甲状腺刺激ホルモン、および、トロポニンが含まれるが、これらに限定されるものではない。抗生物質(例えばゲンタマイシン、バンコマイシンなど)、ジギトキシン、ジゴキシン、乱用薬、テオフィリン、および、ワルファリンのような薬の濃度もモニタしてよい。複数の検体をモニタする実施形態では、これら検体は同時にまたは異なる時間にモニタしてもよい。
さらに別の実施形態では、データ処理ユニット102および/または一次受信ユニット104および/または二次受信ユニット105および/またはデータ処理端末/輸液部105は、通信リンクを介して例えば血糖測定器から血糖値を無線で(または図12に示されるようなワイヤーを介して)受信するように構成してもよい。更に別の実施形態では、例えば、検体監視システム100(図1)を操作または使用するユーザは、データ処理ユニット102、一次受信ユニット104、二次受信ユニット105およびデータ処理端末/輸液部105のうち1つ以上に組み込まれたユーザ・インターフェイス(例えばキーボード、キーパッド、音声コマンドなど)を使用し、手動で血糖値を入力してもよい。
検知層は、検体の電気化学的な酸化または還元を促進するために設計された1つ以上の構成要素を含む。検知層は、例えば、検体の反応を触媒し、かつ作用電極での反応を引き起こす触媒、または、検体と作用電極(または他の構成要素)との間で電子を転送する電子転送剤、或いは、双方を含む。
様々な異なる検知層構成を使用してもよい。ある実施形態では、検知層は、作用電極の導体材料上に堆積される。検知層は、作用電極の導体材料を越えて延びていてもよい。ある場合には、検知層が、さらに他の電極上部に、例えば対極および/または参照電極(或いは、対極/参照電極が設けられる)上部に延びていてもよい。
ある実施形態では、電子転送剤は、サンプルが分析されている期間に電子転送剤の拡散損失を防ぐかまたは実質的に低減する構造または電荷を持つ。例えば、電子転送剤は、作用電極上またはその近傍に配置できる例えばポリマーに結合した酸化還元種を含むものの、それには限定されない。酸化還元種とポリマーの間の結合は共有結合、配位結合、または、イオン結合であってもよい。如何なる有機酸化還元種、有機金属酸化還元種、または、無機酸化還元種もポリマーに結合して電子転送剤として使用してもよいが、ある実施形態では、酸化還元種は、遷移金属化合物または錯体、例えば、オスミウム、ルテニウム、鉄、および、コバルトの化合物または錯体である。ポリマー成分と共に使用されると記述される多くの酸化還元種も、ポリマー成分なしで使用できるものと認められる。
1つの種類の高分子電子転送剤は、ポリマー組成中で共有結合によって結合した酸化還元種を含んでいる。この種の仲介剤の一例は、ポリ(ビニルフェロセン)である。別の種類の電子転送剤はイオン結合の酸化還元種を含む。この種の仲介剤には、逆極性に帯電した酸化還元種に結合した帯電ポリマーが含まれる。この種の仲介剤の例には、オスミウムポリピリジル陽イオンまたはルテニウムポリピリジル陽イオンのような、正に帯電した酸化還元種に結合した負に帯電したポリマーが含まれる。イオン結合した仲介剤の別の例は、フェリシアン酸塩またはフェロシアン酸塩のような負に帯電した酸化還元種に結合した4分割のポリ(4−ビニール・ピリジン)またはポリ(l−ビニール・イミダゾール)のような正に帯電したポリマーである。他の実施形態では、電子転送剤は、ポリマーに配位結合した酸化還元種を含む。例えば、仲介剤は、オスミウムまたはコバルト2,2’−ビピリジル錯体を、ポリ(l−ビニール・イミダゾール)、または、ポリ(4−ビニール・ピリジン)に配位結合させて形成してもよい。
例えば、検知層が、グルコース酸化物、グルコース・デヒドロゲンザエなどの酵素を含み作用電極に接近して配置される過酸化水素検出センサを構築してもよい。検知層は、グルコースに対して選択的に浸透性がある皮膜で覆ってもよい。一旦グルコースが皮膜を通り抜ければ、それは酵素によって酸化され、また、還元されたブドウ糖酸化酵素は、分子酸素と反応することにより酸化され、過酸化水素を生成する。
校正は、生体外テスト・ストリップ(或いは他の基準)、例えば、約1マイクロリットル未満のサンプル(例えば、Abott Diabetes Care社からの「FreeStyle」血糖値監視テスト・ストリップ)を必要とするテスト・ストリップのような小標本テスト・ストリップを使用して遂行してもよい。例えば、約1ナノリットル未満のサンプルを必要とするテスト・ストリップを使用してもよい。ある実施形態では、センサは、1校正イベントあたりでたった1つの体液サンプルを使用して校正してもよい。例えば、(例えばテスト・ストリップ用の)1校正イベントのサンプルを得るためには、ユーザは、単に1回突くのみで足りるか、或いは、最初は十分な量のサンプルが得られない場合には、短時間に複数回突くことでもよい。実施形態は、所定の校正イベントのために、複数のサンプルの体液を得て使用することを含んでおり、その場合、各サンプルのグルコース値は実質的に同じである。所定の校正イベントから得られたデータは、独立して校正に使用するか、或いは、前の校正イベントから得られたデータと結合して、例えば、校正に際して重みつき平均を含む平均をして使用してもよい、ある実施形態では、ユーザはシステムを一度だけ校正する必要があり、その場合には、システムの再校正は必要ではない。
検体システムはオプションの警報装置を含んでいてもよく、例えば、プロセッサからの情報に基づいて、患者に検体の潜在的に有害な条件を警告する。例えば、グルコースが検体の場合には、警報装置は、低血糖症および/または高血糖症および/または切迫した低血糖症および/または切迫した高血糖症をユーザに警告してもよい。検体レベルがしきい値に接近するか、達するか、超過する場合には、警報装置がトリガーされるかも知れない。それに代えて、警報装置は、検体レベルの増大または減少における変化率、または、変化率の加速度が、変化率しきい値または加速度しきい値に近づくか、達したか、超えたときに、活性化されてもよい。システムは、さらに、電池状態、校正、センサ除去、センサ不良などのようなシステム情報をユーザに通知するシステム警報を含んでいてもよい。警報は、例えば聴覚または視覚的でもよい。活性化されたときに、熱するか、冷やすか、振動させるか、または、穏やかな電気的な衝撃を発生する警報装置を含む他の知覚刺激の警報装置を使用してもよい。
ある実施形態は、ASデータ、非盲検データおよびRFモジュールの予想された校正を含んでいる。そのようなシステムの例示的な実施形態が図13に示されている。この実施形態は、ユーザに着用され使用される送信器、AS受信ユニット、ここでは有線通信を使用する(しかし、無線も使用可能)と示されたASシステムにデータを転送することができる生体外メーター、並びに、RFモジュールおよびDMSを有するASデータ処理ユニットを備える。従って、本実施形態では、ASシステムのグルコース結果は、リアルタイムにディスプレイ上で聴覚的および視覚的にユーザに伝えられる。生体外の血糖測定器からAS受信器まで、例えばRF、および、生体外メーターに接続された無線アダプタを使用したデータの単一方向の転送が行われる。しかし、生体外メーターがASデータを表示することを可能にするデータの双方向転送(つまり、生体外メーターが連続的な検体センサデータを出力する機能を含む)であってもよい。
図16は、例示的な実施形態の表およびそれに含まれるそれぞれの特徴を示す。いかなる特徴も、他の実施形態および/または特徴と組み合わせてもよく、且つ/または、任意の実施形態から削除しても、且つ/または、これに加算してもよい。
上記したように、実施形態は患者のプライバシーを保証するように構成され、例えば、HIPPAコンプライアントである。例えば、上述のように、幾つかの実施形態は、複数の個人によって使用されてもよい構成要素を含んでいる。患者データは、識別される患者識別子(ID)であるかも知れず、第1のユーザからの患者データの全ては、システムが第2のユーザのために(例えばHCPによって)構成される場合には、システム或いは1つ以上のシステム構成要素から自動的に削除してもよい。例えば、ASデータ処理ユニットおよび/または受信ユニットは、パスワード或いは他の固有な患者識別子の入力を要求するHCPまたはユーザによって行なわれる各使用或いはユーザの初期化手続きを要求してもよい。患者に特有なデータは自動的に削除してもよい。或いは、初期化子は、CGシステムの初期化中に削除するように促してもよい。同様に、患者に特有なデータは、スクランブルをかけても、暗号化してもよく、さもなければ、見分けにくくしてもよい。患者データは、ある実施形態では、時間スケジュールに基づいて削除してもよい。
データ収集モジュールは、データストレージ装置、および、ランダム・アクセス・メモリでもあり得るメモリ装置の1つ以上を含んでもよい。
更に、通信モジュールは、校正された検体データを遠隔部に送信するように構成してもよい。
方法は、USBケーブル接続、シリアルケーブル接続、RF通信プロトコル、赤外線通信プロトコル、ブルートゥース通信プロトコル、および、802.11x通信プロトコルのうち1つ以上を使用して、遠隔部と通信することを含んでいてもよい。
更に別の態様では、方法が、検体データを遠隔部に転送した後に、保存された検体データを削除することを含んでいてもよい。
方法が、校正された検体情報を保存することを含んでいてもよい。
102:データ処理ユニット
104:一次受信ユニット
105:データ処理端末/輸液部
106:二次受信ユニット
201:アナログ・インターフェイス
202:ユーザユニット
203:温度測定部
204:プロセッサ
205:シリアル通信部
206:RF送信器/受信器
207:電源装置
208:クロック
214:漏洩検出回路
301:テスト・ストリップ・インターフェイス
302:RF受信器
303:ユーザ入力
304:温度監視部
305:クロック
306:電源装置
307:プロセッサ/ストレージ
308:電力変換/監視部
309:シリアル通信部
310:出力/表示
500:センサ
510:皮膚表面
520:皮下スペース
530:挿入先端
Claims (33)
- 被検者から所定期間にわたって検体データを採取し保存するデータ収集モジュール;
前記検体データに関連する1つ以上の表示を提供するために前記データ収集モジュールに接続されたユーザ・インターフェイス・ユニット;
前記データ収集モジュールおよび前記ユーザ・インターフェイス・ユニットに接続され、前記データ収集モジュールおよび前記ユーザ・インターフェイス・ユニットの動作を少なくとも部分的に制御する制御ユニット;および
前記制御ユニットに接続され、前記検体データに関連する1つ以上の信号を遠隔部に通信する通信モジュール、
を備え、
前記ユーザ・インターフェイス・ユニットは、前記データ収集モジュールによって採取された検体レベルのリアルタイム出力を含む予測的分析モードと、前記所定期間にわたる被検者への制限された情報出力を含む遡及的分析モードとで作動するように構成され;かつ
前記通信モジュールは、所定期間にわたって前記検体データが採取され、前記データ収集モジュールに保存された後に遠隔部と通信するように構成されることを特徴とする検体監視装置。 - 血糖テスト・ストリップを収容するために制御ユニットに作動的に接続されたストリップ・ポートを更に備えることを特徴とする請求項1記載の装置。
- 前記通信モジュールが、USBケーブル接続、シリアルケーブル接続、RF通信プロトコル、赤外線通信プロトコル、ブルートゥース通信プロトコル、および、802.11x通信プロトコルのうち1つ以上を使用して、前記遠隔部と通信するように構成されることを特徴とする請求項1記載の装置。
- 前記ユーザ・インターフェイス・ユニットが、遡及的分析モードでは受信された検体データと関連する情報を表示しないように構成されることを特徴とする請求項1の装置。
- 前記遡及的分析モードにおける制限された情報出力が、検体監視装置運転状態情報、時刻情報、ユーザ・プロフィール情報、および、前記所定期間のうちの経過期間のうち1つ以上をユーザ・インターフェイス・ユニットに出力することを含むことを特徴とする請求項1記載の装置。
- 前記データ収集モジュールが、データ保存装置およびメモリ装置のうち1つ以上を含むことを特徴とする請求項1記載の装置。
- 前記メモリ装置がランダム・アクセス・メモリを含むことを特徴とする請求項6記載の装置。
- 前記データ収集モジュールが、前記遠隔部へ検体データを転送した後に、前記保存された検体データを削除するように構成されることを特徴とする請求項1記載の装置。
- 前記遠隔部がデータ処理端末を含むことを特徴とする請求項1記載の装置。
- 前記ユーザ・インターフェイス・ユニットが、前記予測的分析モードでは、採取された被検者の検体データと関連するリアルタイム情報を視覚的に出力するように構成されることを特徴とする請求項1の装置。
- 前記視覚的な出力が、グラフィカルな出力、数値の出力、および、テキスト出力のうち1つ以上を含むことを特徴とする請求項10記載の装置。
- 前記データ収集モジュールに保存された検体データが校正されていないことを特徴とする請求項1記載の装置。
- 前記遠隔部への検体データと関連する、通信された1つ以上の信号が校正されていない検体データを含むことを特徴とする請求項1記載の装置。
- 前記通信モジュールが、1つ以上の校正用情報を得るように構成されることを特徴とする請求項1記載の装置。
- 前記校正用情報が血糖データを含むことを特徴とする請求項14記載の装置。
- 前記制御ユニットが、採取され保存された検体データを、受信した校正用情報に基づいて校正し、該校正された検体データを生成するように構成されることを特徴とする請求項14記載の装置。
- 前記データ収集モジュールが、前記校正された検体データを保存するように構成されることを特徴とする請求項16記載の装置。
- 前記通信モジュールが、校正された検体データを前記遠隔部に送信するように構成されることを特徴とする請求項16記載の装置。
- 被検者から採取された検体データを所定期間にわたって保存し;
前記採取された検体データに関連づけられた1つ以上の表示をユーザ・インターフェイス・ユニットに与え、データ収集モジュールによって採取された検体レベルの実質的なリアルタイム出力を含む予測的分析モード、および、前記所定期間中の被検者への制限された情報出力を含む遡及的分析モードにおいて前記ユーザ・インターフェイス・ユニットを動作させ;
検体データが前記所定時間採取され保存された後に、前記検体データに関連する1つ以上の信号を遠隔部に通信することを特徴とする方法。 - 血糖テスト結果を採取することを含む請求項19記載の方法。
- USBケーブル接続、シリアルケーブル接続、RF通信プロトコル、赤外線通信プロトコル、ブルートゥース通信プロトコル、および、802.11x通信プロトコルのうち1つ以上を使用して遠隔部と通信することを含む請求項19記載の方法。
- 前記遡及的分析モードでは、前記採取された検体データに関連する情報を表示しないことを含む請求項19記載の方法。
- 前記遡及的分析モードにおける制限された情報出力が、運転状態情報、時刻情報、ユーザ・プロフィール情報、および、所定期間のうちの経過期間のうち1つ以上を出力することを含むことを特徴とする請求項19記載の方法。
- 遠隔部へ検体データを転送した後に、前記保存された検体データを削除することを含む請求項19記載の方法。
- 前記予測的分析モードでは、前記採取された検体データに関連するリアルタイム情報を視覚的に出力することを特徴とする請求項19記載の方法。
- 前記視覚的な出力が、グラフィカルな出力、数値の出力、および、テキスト出力のうち1つ以上を含むことを特徴とする請求項25記載の方法。
- 保存された検体データが校正されていないことを特徴とする請求項19記載の方法。
- 校正されていない検体データを遠隔部へ送信することを含むことを特徴とする請求項19記載の方法。
- 1つ以上の校正用情報を受信することを含むことを特徴とする請求項19記載の方法。
- 前記校正用情報が血糖データを含むことを特徴とする請求項29記載の方法。
- 前記受信した校正用情報に基づいて、前記保存された検体データを校正し、校正された検体データを生成することを含むことを特徴とする請求項30記載の方法。
- 前記校正された検体データを保存することを特徴とする請求項31記載の方法。
- 前記遠隔部へ校正された検体データを送信することを特徴とする請求項31記載の方法。
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JP7196315B2 (ja) | 2019-01-28 | 2022-12-26 | アボット ダイアベティス ケア インコーポレイテッド | グルコースとケトンの二重検出を特徴とする分析対象物センサー及び検出方法 |
JP7448621B2 (ja) | 2019-01-28 | 2024-03-12 | アボット ダイアベティス ケア インコーポレイテッド | グルコースとケトンの二重検出を特徴とする分析対象物センサー及び検出方法 |
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US20180325434A1 (en) | 2018-11-15 |
JP5680960B2 (ja) | 2015-03-04 |
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AU2008265541A1 (en) | 2008-12-24 |
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EP3533387A3 (en) | 2019-11-13 |
CA2690742A1 (en) | 2008-12-24 |
US11276492B2 (en) | 2022-03-15 |
EP2171031A1 (en) | 2010-04-07 |
US20130113632A1 (en) | 2013-05-09 |
US20210151182A1 (en) | 2021-05-20 |
AU2008265541B2 (en) | 2014-07-17 |
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US20210000396A1 (en) | 2021-01-07 |
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