JP6850940B2 - 冠血流予備量比を評価するためのシステム - Google Patents
冠血流予備量比を評価するためのシステム Download PDFInfo
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- JP6850940B2 JP6850940B2 JP2020505451A JP2020505451A JP6850940B2 JP 6850940 B2 JP6850940 B2 JP 6850940B2 JP 2020505451 A JP2020505451 A JP 2020505451A JP 2020505451 A JP2020505451 A JP 2020505451A JP 6850940 B2 JP6850940 B2 JP 6850940B2
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Description
上記実施形態のいずれかに代えて又はこれに加えて、圧力感知ガイドワイヤは、第1内径を有する近位領域と、第1内径とは異なる第2内径を有する遠位領域とを有する管状部材を含む。
上記実施形態のいずれかに代えて又はこれに加えて、第1圧力、第2圧力又は両方が、プロセッサに無線送信される。
上記実施形態のいずれかに代えて又はこれに加えて、第2圧力感知医療機器は、血管内病変の近位に配置されるように設計される。
上記実施形態のいずれかに代えて又はこれに加えて、ディスプレイは、プロットを表示するように設計される。
上記実施形態のいずれかに代えて又はこれに加えて、圧力感知ガイドワイヤは、第1内径を有する近位領域と、第1内径とは異なる第2内径を有する遠位領域とを有する管状部材を含む。
上記実施形態のいずれかに代えて又はこれに加えて、プロセッサは、ディスプレイに接続される。
冠血流予備量比を測定するための方法が開示される。この方法は、血管内病変の遠位に圧力感知ガイドワイヤを配置し、圧力感知ガイドワイヤで遠位圧力を測定し、血管部位に圧力感知カテーテルを配置し、圧力感知カテーテルで大動脈圧を測定することを含む。この方法において、プロセッサは、圧力感知ガイドワイヤ及び圧力感知カテーテルに接続される。この方法において、プロセッサは、経時的に大動脈圧の大きさのプロットを作成し、ゼロ未満の傾きを有するプロットの1以上の時間間隔を特定し、大動脈圧の平均値を測定し、(a)大動脈圧が大動脈圧の平均値以下であり、(b)1以上の時間間隔の間でプロットの傾きがゼロ未満であるとき、大動脈圧に対する遠位圧力の比を算出するように設計される。
本明細書におけるすべての数値は、明示されているか否かにかかわらず、用語「約」によって修飾されているものとする。用語「約」は、一般に、当業者が、記載された数値に相当する(例えば同じ機能又は結果を有する)とみなすであろう一定範囲の数のことをいう。多くの場合、用語「約」は、最も近い有効数字に端数を切り捨てた数を含んでもよい。
本明細書及び添付の特許請求の範囲で使用されるとき、単数形「a」「an」、及び「the」は、文脈上そうでないとする明確な指示がない限り複数の指示対象を含む。本明細書及び添付の特許請求の範囲で使用されるとき、用語「又は」は、一般に、文脈上そうでないとする明確な指示がない限り、「及び/又は」を包含する意味で用いられる。
(例えば第1圧力感知医療機器10によって測定され、図2に示されるように)経時的に遠位圧力Pdの大きさのプロットを作成すること、
(例えば第2圧力感知医療機器74によって測定され、図2に示されるように)経時的に大動脈圧Paの大きさのプロットを作成すること、
プロットの傾きがゼロ未満であるPaのプロットの1以上の時間間隔を特定すること、
平均大動脈圧92を算出/測定すること、
1以上のさらなる計算、及び/又は
その組み合わせ
を含む、いくつかのタスクを行うために利用されてもよい。
(a)Paが平均大動脈圧92以下であり、かつ
(b)傾きPaがゼロ未満である
心周期の領域が特定される。
(a)Paが、0.5〜1.5、又は約0.75〜1.25、又は約0.95〜1.05の範囲のスケーリングファクタによってスケーリングされた平均大動脈圧92以下であり(例えば、Paがスケーリングファクタを掛けられた平均大動脈圧92以下である心周期の領域が特定され)、かつ
(b)傾きPaがゼロ未満である
心周期の領域が特定される。
(a)Paが、0.5〜1.5もしくは約0.75〜1.25もしくは約0.95〜1.05の範囲のスケーリングファクタによってスケーリングされた平均大動脈圧92以下であり、ならびに/又は、
(b)傾きPaがゼロ未満であり、ならびに/又は、
(c)Paが、以下の方法の1つ、すなわち、
i)平均大動脈圧92からの−10mmHg〜−100mmHgの範囲の負の固定オフセット、
ii)平均大動脈圧92の10%〜100%によって計算された平均大動脈圧92からの負の相対オフセット、及び/もしくは
iii)最小大動脈圧95からの10mmHg〜100mmHgの範囲の正の固定オフセット
によって測定することができる圧下限よりも大きい、
心周期の領域が特定される。平均大動脈圧92は、個々の心周期について、又はいくつかの心周期にわたって測定されてもよい。これらの基準を満たす時間窓又は領域は、高血流期中(例えば拡張期中)であると考えられ、FFRの評価/測定に使用するのに適していると考えられる。このように、システム100は、充血剤の非存在下でかつ不必要なさらなるプロセス及び同期の両方もしくは一方を必要とすることなく、又は、充血剤の非存在下で又は不必要なさらなるプロセス及び同期の両方もしくは一方を必要とすることなく、これらの期間の間でFFRを評価/測定/算出するために利用することができる。図2に示すグラフにおいて、これらの基準を満たす3つの時間領域96a、96b、96cが画定される。他のプロット/グラフにおいて、当然のことながら、より少ない又はより多い時間領域が特定されてもよい。これらの時間領域96a、96b、96cの間でFFRを評価/測定/算出するためにプロセッサ88を利用することができる。
Claims (15)
- 第1圧力を測定するための圧力感知ガイドワイヤと、
第2圧力を測定するための第2圧力感知医療機器と、
前記圧力感知ガイドワイヤ及び前記第2圧力感知医療機器に接続されたプロセッサとを含む、冠血流予備量比を測定するためのシステムであって、前記プロセッサが、
経時的に前記第2圧力の大きさのプロットを作成し、
ゼロ未満の傾きを有する前記プロットの1以上の時間間隔を特定し、
前記第2圧力の平均値を測定し、
(a)前記第2圧力が前記第2圧力の前記平均値以下であり、
(b)前記1以上の時間間隔の間で前記プロットの前記傾きがゼロ未満であるとき、
前記第2圧力に対する前記第1圧力の比を算出するように設計される、システム。 - 前記圧力感知ガイドワイヤが光圧力センサを含む、請求項1に記載のシステム。
- 前記圧力感知ガイドワイヤが、第1内径を有する近位領域と、前記第1内径とは異なる第2内径を有する遠位領域とを有する管状部材を含む、請求項1〜2のいずれか一項に記載のシステム。
- 前記第2圧力感知医療機器が、圧力センサを有するカテーテルからなる、請求項1〜3のいずれか一項に記載のシステム。
- 前記第1圧力、前記第2圧力又は両方が前記プロセッサに無線送信される、請求項1〜4のいずれか一項に記載のシステム。
- 前記プロセッサが、充血剤の非存在下で前記第2圧力に対する前記第1圧力の前記比を算出するように設計される、請求項1〜5のいずれか一項に記載のシステム。
- 前記プロセッサがディスプレイに接続される、請求項1〜6のいずれか一項に記載のシステム。
- 前記ディスプレイが前記プロットを表示するように設計される、請求項7に記載のシステム。
- 病変の遠位位置における遠位圧力を測定するための圧力感知ガイドワイヤと、
大動脈圧を測定するための圧力感知カテーテルと、
前記圧力感知ガイドワイヤ及び前記圧力感知カテーテルに接続されたプロセッサとを含む冠血流予備量比を測定するためのシステムであって、前記プロセッサが、
経時的に前記大動脈圧の大きさのプロットを作成し、
ゼロ未満の傾きを有する前記プロットの1以上の時間間隔を特定し、
前記大動脈圧の平均値を測定し、
(a)前記大動脈圧が大動脈圧の前記平均値以下であり、
(b)前記1以上の時間間隔の間で前記プロットの前記傾きがゼロ未満であるとき、
前記大動脈圧に対する前記遠位圧力の比を算出するように設計される、システム。 - 前記圧力感知ガイドワイヤが光圧力センサからなる、請求項9に記載のシステム。
- 前記圧力感知ガイドワイヤが、第1内径を有する近位領域と、前記第1内径とは異なる第2内径を有する遠位領域とを有する管状部材を含む、請求項9〜10のいずれか一項に記載のシステム。
- 前記プロセッサが、充血剤の非存在下で前記大動脈圧に対する前記遠位圧力の前記比を算出するように設計される、請求項9〜11のいずれか一項に記載のシステム。
- 前記プロセッサがディスプレイに接続される、請求項9〜12のいずれか一項に記載のシステム。
- 前記プロセッサが、0.75〜1.25の範囲のスケーリングファクタによって前記平均大動脈圧をスケーリングするように設計される、請求項9〜13のいずれか一項に記載のシステム。
- 前記大動脈圧が下限圧力未満のとき、前記プロセッサが時間間隔を不採用とするように設計される、請求項9〜14のいずれか一項に記載のシステム。
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