JP6454729B2 - 心不全悪化の自動鑑別診断のための医療デバイスシステム - Google Patents
心不全悪化の自動鑑別診断のための医療デバイスシステム Download PDFInfo
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- A61B5/316—Modalities, i.e. specific diagnostic methods
- A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
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Description
本明細書において、用語「1つの(a)」または「1つの(an)」は、特許文献において一般的であるように、「少なくとも1つ」または「1つまたは複数」のあらゆる他の例または用法とは無関係に、1つまたは2つ以上を含むように用いられる。別段の指示がない限り、本明細書において、用語「または(or)」は、非排他的であることを指すように、または「AまたはB」が、「AであるがBではない」、「BであるがAではない」、および「AおよびB」を含むように用いられる。本明細書において、用語「含む(including)」および「ここで(in which)」は、「備える(comprising)」および「ここで(wherein)」という用語の平易な英語の同義語として用いられる。また、以下の特許請求の範囲においては、用語「含む(including)」および「備える(comprising)」は、非限定的なものである。すなわち、特許請求の範囲においてそのような用語の後に列記されたものに加えて要素を含むシステム、デバイス、物品、組成、配合、またはプロセスは、やはりその特許請求の範囲内にあるとみなされる。さらに、以下の特許請求の範囲において、用語「第1の」、「第2の」、および「第3の」等は、単にラベルとして用いられており、それらの対象に対して数的な要件を課すことを意図するものではない。
Claims (14)
- 医療デバイスシステムであって、
患者から取得された2つ以上の生理学的信号を含む患者情報を受信するように構成された患者情報受信回路と、
受信された前記2つ以上の生理学的信号のそれぞれから、患者の物理的状態または生理学的状態を示すそれぞれの生理学的特徴を検出するように構成された生理学的データ分析回路と、
1つまたは複数の前記生理学的特徴を用いて、1つまたは複数の信号メトリックであって、前記患者の物理的状態または生理学的状態の変化を示すか、または前記患者の物理的状態または生理学的状態の変化に相関している1つまたは複数の信号メトリックを生成し、前記患者の物理的状態または生理学的状態の変化に関連付けされた2つ以上の候補症状であって、前記患者の物理的状態または生理学的状態の変化を示すか、または前記患者の物理的状態または生理学的状態の変化に相関している前記生成された信号メトリックに応じて選択された2つ以上の候補症状を、前記医療デバイスシステムに接続された記憶システムから受信し、かつ
前記2つ以上の候補症状に対して、前記1つまたは複数の信号メトリックを用いて、それぞれの診断評点であって、対応する前記候補症状によって引き起こされる前記患者の物理的状態または生理学的状態の前記変化の尤度を示す診断評点を決定するように構成された鑑別診断回路と
を備え、
前記鑑別診断回路が、少なくとも第1の信号メトリックと、異なる第2の信号メトリックとの間の時間的関係を用いて、前記それぞれの診断評点を決定する、医療デバイスシステム。 - 前記鑑別診断回路が、心不全(HF)の悪化事象、肺疾患、腎臓病、睡眠呼吸障害の兆候、心房性不整脈もしくは心室性不整脈、または感染症の兆候を含む2つ以上の候補症状を受信するように構成されている、請求項1に記載の医療デバイスシステム。
- 前記鑑別診断回路が、それぞれの基準レベルから前記1つまたは複数の信号メトリックの変化または変化率を決定するように、かつ特定の基準をそれぞれ満たしている前記1つまたは複数の信号メトリックの前記変化または前記変化率に応じて、前記それぞれの診断評点を決定するように構成されている、請求項1または2に記載の医療デバイスシステム。
- 前記鑑別診断回路が、ルールベースモデルを用いて、前記それぞれの診断評点を決定するように構成されている、請求項1〜3のいずれか一項に記載の医療デバイスシステム。
- 前記ルールベースモデルが、複数レベルのデシジョンツリーモデルを含み、および前記鑑別診断回路が、特定の基準をそれぞれ満たしている前記1つまたは複数の信号メトリックに応じて、前記それぞれの診断評点を決定する、請求項4に記載の医療デバイスシステム。
- 前記第1の信号メトリックと前記第2の信号メトリックとの間の前記時間的関係が、前記第1の信号メトリックに関連付けされた第1のタイミングと、前記第2の信号メトリックに関連付けされた第2のタイミングとの間の比較を含む、請求項1に記載の医療デバイスシステム。
- 前記鑑別診断回路が、確率モデルを用いて前記それぞれの診断評点を決定するように構成され、前記診断評点が、前記患者が前記2つ以上の候補症状のうちの1つを経験する確率値、または前記患者が前記2つ以上の候補症状のうちの1つを将来発症する確率値を含む、請求項1〜3および6のいずれか一項に記載の医療デバイスシステム。
- 前記鑑別診断回路が、前記生理学的信号の特徴のうちの複数の測定値を用いて、前記1つまたは複数の信号メトリックを算出するように構成され、前記1つまたは複数の信号メトリックが、統計的メトリックまたは形態的メトリックを含む、請求項1〜7のいずれか一項に記載の医療デバイスシステム。
- 前記患者情報受信回路が、インピーダンスセンサを用いて、胸部インピーダンス信号を受信するように構成され、および前記鑑別診断回路が、前記胸部インピーダンス信号を用いて、呼吸の強さの測定値、呼吸数、または呼吸パターンのうちの1つまたは複数の変化を算出するように構成されている、請求項1〜8のいずれか一項に記載の医療デバイスシステム。
- 前記患者情報受信回路が、心音センサを用いて、心音(HS)信号を受信するように構成されている、請求項1〜9のいずれか一項に記載の医療デバイスシステム。
- 前記鑑別診断回路が、HS成分であって、S1心音と、S2心音と、S3心音またはS4心音とのうちの1つまたは複数を含むHS成分の強度を含む、1つまたは複数の信号メトリックを生成するように構成されている、請求項10に記載の医療デバイスシステム。
- 前記患者情報受信回路が、慢性疾患情報、以前の医療処置または治療情報、患者の人口統計情報、患者の生命徴候情報、患者の症候情報、または患者の共存疾患の症状のうちの1つまたは複数を含む、前記患者情報を受信するように構成されている、請求項1〜11のいずれか一項に記載の医療デバイスシステム。
- 前記検出された生理学的特徴、または前記2つ以上の候補症状に関連付けされた前記診断評点のうちの1つまたは複数の提示を提供するように構成されたユーザインタフェースをさらに備える、請求項1〜12のいずれか一項に記載の医療デバイスシステム。
- 前記鑑別診断回路が、前記診断評点の間の比較を用いて、最も確度の高い診断であって、最も高い診断評点に関連付けされた最も確度の高い診断を決定するようにさらに構成され、かつ
前記ユーザインタフェースが、前記最も確度の高い診断を含む前記提示を提供するように構成されている、請求項1〜13のいずれか一項に記載の医療デバイスシステム。
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