WO2023089866A1 - Dispositif de traitement de normalisation et procédé de traitement de normalisation pour forme d'onde de pression - Google Patents

Dispositif de traitement de normalisation et procédé de traitement de normalisation pour forme d'onde de pression Download PDF

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Publication number
WO2023089866A1
WO2023089866A1 PCT/JP2022/027956 JP2022027956W WO2023089866A1 WO 2023089866 A1 WO2023089866 A1 WO 2023089866A1 JP 2022027956 W JP2022027956 W JP 2022027956W WO 2023089866 A1 WO2023089866 A1 WO 2023089866A1
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Prior art keywords
pressure
time
index value
waveform
standardization processing
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PCT/JP2022/027956
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English (en)
Japanese (ja)
Inventor
拓也 水上
世史明 川瀬
雅文 中山
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拓也 水上
合同会社Medboost
世史明 川瀬
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Application filed by 拓也 水上, 合同会社Medboost, 世史明 川瀬 filed Critical 拓也 水上
Publication of WO2023089866A1 publication Critical patent/WO2023089866A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A61B5/0215—Measuring pressure in heart or blood vessels by means inserted into the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/024—Detecting, measuring or recording pulse rate or heart rate
    • A61B5/0245—Detecting, measuring or recording pulse rate or heart rate by using sensing means generating electric signals, i.e. ECG signals

Definitions

  • the present invention relates to a pressure waveform standardization processing apparatus and a pressure waveform standardization processing method that performs standardization processing for evaluating heart disease based on a pressure waveform representing temporal changes in intravascular pressure at a predetermined site of a subject.
  • a method using a guide wire with a pressure sensor called a pressure wire is known.
  • pressure wires are used to measure the aortic pressure Pa (aortic pressure), which is the coronary artery inlet pressure, and the coronary artery pressure Pd (distal pressure), which is downstream of the stenosis site in the coronary artery.
  • the presence or absence of myocardial ischemia is determined using the pressure ratio (Pd/Pa) of these aortic pressure Pa and coronary artery pressure Pd as a diagnostic index.
  • the pressure ratio there are a myocardial blood flow reserve ratio (FFR: Fractional Flow Reserve) and a resting non-hyperemic pressure ratio (NHPR: Non-Hyperemic Pressure Ratio) depending on the measurement conditions (Patent Document 1. etc.). All of these are diagnostic indices based on the pressure gradient, which is the pressure difference that occurs when blood flows through a lesion in the coronary artery.
  • FFR Fractional Flow Reserve
  • NHPR Non-Hyperemic Pressure Ratio
  • the FFR is an index obtained in a state of maximal hyperemia in which microvascular resistance is lowered by administering a drug to a patient, and when it falls below a predetermined value (e.g., 0.80), it is diagnosed as myocardial ischemia. It is used as a guideline for treatment such as coronary artery stent placement.
  • the blood flow in the coronary arteries is not a constant amount, but the blood flow velocity and blood flow volume differ between the systole and diastole in the cardiac cycle.
  • blood flow patterns in coronary arteries are affected by various factors such as blood pressure, pulse rate, right and left coronary arteries, severity of coronary artery stenosis and microcirculatory disorder, and presence or absence of valvular disease.
  • the FFR and the NHPR are calculated by a uniform formula regardless of the coronary artery to be measured and the condition of the patient.
  • the coronary arteries of patients with hypertrophic myocardium due to aortic stenosis are generally considered to have microcirculatory disorders.
  • the present inventors have found that patients with and without aortic stenosis have different coronary artery pressure waveforms, and that changes in pressure waveforms with respect to drug-induced maximal hyperemia are different. Therefore, in a diagnosis based on the above-mentioned index from the conventional pressure waveform, for example, even for a patient who can be treated only for valvular disease and does not need to be treated for coronary artery disease, the above-mentioned index can be used to treat coronary heart disease. You might get the recommended results.
  • the coronary artery microcirculatory disorder is calculated from the blood flow waveform in the coronary artery measured using a catheter-type wire called a Doppler flow wire, or is calculated by the thermodilution method of the coronary artery. It is possible. However, the method of measuring blood flow using such a Doppler flow wire is reported to have a probability of obtaining satisfactory data of about 69%, and is not widely used due to high technical hurdles.
  • the present invention has been devised with a focus on such problems, and its object is to more accurately evaluate heart disease based on pressure waveforms representing temporal changes in intravascular pressure of a subject.
  • the object of the present invention is to provide a pressure waveform standardization processing device and a standardization processing method for performing data processing for the purpose.
  • the present invention provides an apparatus that performs standardization processing for evaluating heart disease based mainly on pressure data of a pressure waveform representing changes in the intravascular pressure of a subject over time. is specified, and subdivides one heartbeat into a plurality of time phases, a time phase dividing unit that standardizes the time scale within each time phase, and an index value for evaluating the heart disease from the pressure data. and an index value calculation unit that associates the index value with the time scale, and the time phase division unit sets one or more predetermined feature points within one heartbeat, and divides each time zone by the feature points. is converted to the time on the unified time scale.
  • FIG. 1 is a block diagram schematically showing the configuration of a heart disease evaluation support system including a standardization processing device according to the present invention
  • FIG. 1 is a graph of pressure waveforms for aortic pressure and coronary artery pressure in one heartbeat
  • 1 is a graph of normalized waveforms for aortic pressure and coronary artery pressure in one heartbeat
  • FIG. 10 is a graph of normalized waveforms with respect to pressure ratio in one heartbeat
  • FIG. 1 shows a block diagram schematically showing the configuration of a heart disease evaluation support system including a standardization processing device according to the present invention.
  • the evaluation support system 10 is a system that performs data processing for supporting the evaluation of heart disease based on pressure waveforms in which the intravascular pressure at a predetermined site of a subject such as a patient is associated with the acquisition time. be.
  • This evaluation support system 10 includes an intravascular pressure measuring device 11 for measuring the intravascular pressure of a subject, and pressure waveform data based on the intravascular pressure acquired by the intravascular pressure measuring device 11 for evaluating heart disease. and a display device 13 such as a display for displaying various information including information based on the processing result of the standardization processing device 12 .
  • the intravascular pressure measuring device 11 a known cardiac catheterization device capable of measuring intravascular pressure by inserting a guide wire with a pressure sensor called a pressure wire into the blood vessel is used.
  • the aortic pressure Pa and the coronary artery pressure Pd are measured as pressure data at predetermined time intervals, and pressure waveforms (see FIG. 2) representing changes over time are acquired for each.
  • the intravascular pressures on the upstream and downstream sides of a stenotic lesion in a coronary artery are measured, the pressure at the proximal stenotic region on the upstream side is taken as the aortic pressure Pa, and the pressure at the distal stenotic region on the downstream side is taken as Pa. is taken as the coronary artery pressure Pd.
  • the standardization processing device 12 is composed of a computer comprising an arithmetic device such as a CPU and a storage device such as a memory and a hard disk, and programs are installed to make the computer function as the following units.
  • the standardization processing device 12 includes a storage unit 15 that stores pressure data (pressure waveform) consisting of the aortic pressure Pa and the coronary artery pressure Pd acquired by the intravascular pressure measuring device 11 at each acquisition time, and a cardiac cycle from the pressure data.
  • a time phase dividing unit 16 that identifies and subdivides one heartbeat into a plurality of time phases and standardizes the time scale within each time phase, and calculates an index value for evaluating heart disease from pressure data, and calculates the index value and an index value calculator 17 that associates a value with a time scale.
  • the time-phase dividing unit 16 divides the pressure waveform (solid line in FIG. 2) of the aortic pressure Pa during one heartbeat into a dicrotic notch (DN) in which the pressure intensity fluctuates greatly when the aortic valve is closed.
  • a corresponding time (a dashed dotted line in the figure) is specified as a feature point.
  • the time zone before and after the DN portion is divided into a first time phase T1 corresponding to systole and a second time phase T2 corresponding to diastole.
  • the time scale is unified and converted into standardized time. For example, as shown on the horizontal axis of FIG.
  • the DN time is set to zero, and each time in the first phase T1 is the ratio of the elapsed time from the beginning of the systole to the DN. It is converted to the corresponding time (-100 to 0 (sec)). On the other hand, each time in the second phase T1 is converted into a time (0 to 100 (sec)) corresponding to the ratio of elapsed time from DN to the end of diastole.
  • the maximum aortic pressure Pmax during one heartbeat is defined as a feature point, and the pressure data during one heartbeat in the time zones before and after the feature point are obtained in the first and second time phases T1, It can also be partitioned as T2 and converted to standardized time as before. Furthermore, a plurality of feature points are set in the time zone when the aortic pressure Pa and the coronary artery pressure P decrease from the maximum aortic pressure Pmax during one heartbeat, and the time zone is divided at each feature point and standardized as described above. You can also set the time scale that is used. In addition, in the diastolic phase during one heartbeat, the mid-diastolic to end-diastolic phase (WFP (see FIG.
  • Wave free period of the heart used in the resting non-hyperemic pressure ratio (NHPR) is used as a feature point. It is also possible to extract a part of the time zone, such as cutting out the time zone, and set the above-mentioned time scale for each time zone. Furthermore, a predetermined feature point is specified in the Pd/Pa waveform representing the relationship of the pressure ratio Pd/Pa to the time during one heartbeat, and the time scale described above is set in each time zone divided by the feature point.
  • a device capable of measuring a predetermined intravascular pressure or based on the measurement results of an electrocardiogram (not shown) or the like, identifies a cardiac cycle, and determines one or more timings having predetermined characteristics within the cardiac cycle.
  • Various aspects can be adopted as long as the time of one heartbeat is divided at the feature point and the time of each time zone is converted into a standardized time.
  • the index value calculation unit 17 calculates the pressure ratio Pd/Pa obtained by dividing the coronary artery pressure Pd by the aortic pressure Pa, and the maximum aortic pressure Pa and the coronary artery pressure Pd. Standardized blood pressure Pa/Pmax and Pd/Pmax (%) divided by Pmax are calculated as index values.
  • the index value calculation unit 17 calculates a standardized time within one heartbeat, which varies between subjects, and a standardized blood pressure Pa/ A standardized waveform corresponding to Pmax, Pd/Pmax and pressure ratio Pd/Pa is generated.
  • the aortic pressure Pa, the coronary artery pressure Pd, the pressure value Pd/Pa, and the standardized blood pressure Pa/Pmax, Pd/Pmax are the average value, the median value, or the predetermined Calculated values are determined and these values are also available as indicators in assessing heart disease.
  • the standardized blood pressure Pa/Pmax and Pd/Pmax can be obtained to standardize the index values related to pressure to 1.0 (100%) or less.
  • the waveform corresponding to the intravascular pressure is converted into a standardized waveform.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Physiology (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Signal Processing (AREA)
  • Vascular Medicine (AREA)
  • Measuring Pulse, Heart Rate, Blood Pressure Or Blood Flow (AREA)

Abstract

Un dispositif de traitement de normalisation (10) selon la présente invention comprend : une unité de division de phase de temps (16) qui identifie un cycle cardiaque, sous-divise un battement de coeur en une pluralité de phases de temps, et normalise l'échelle de temps à l'intérieur de chaque phase de temps ; et une unité de calcul de valeur d'indice (17) qui calcule une valeur d'indice pour évaluer une maladie cardiaque à partir de données de pression d'une forme d'onde de pression qui représente des changements dans le temps dans la pression intravasculaire d'un sujet, et associe la valeur d'indice à l'échelle de temps. L'unité de division de phase de temps (16) définit un ou plusieurs points de caractéristiques prédéterminés dans un battement de cœur et convertit, en un temps sur une échelle de temps unifiée, le temps de chaque zone de temps obtenu par division par les points de caractéristiques. L'unité de calcul de valeur d'indice (17) génère une forme d'onde normalisée qui représente la relation entre chaque temps sur l'échelle de temps et la pression intravasculaire et la valeur d'indice.
PCT/JP2022/027956 2021-11-18 2022-07-18 Dispositif de traitement de normalisation et procédé de traitement de normalisation pour forme d'onde de pression WO2023089866A1 (fr)

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2003525067A (ja) * 1999-03-09 2003-08-26 フローレンス・メディカル・リミテッド Ｃｆｒおよび付加的な臨床的血流力学パラメータを圧力ベースで測定するための方法およびシステム
JP2016508049A (ja) * 2012-12-26 2016-03-17 ヴォルカノ コーポレイションＶｏｌｃａｎｏ Ｃｏｒｐｏｒａｔｉｏｎ マルチモダリティ医療用撮像システムにおける測定および強調
JP2016534770A (ja) * 2013-10-18 2016-11-10 ボルケーノ コーポレイション 充血剤を使用することなく取得された近位及び遠位圧力測定値の最適化によって導管を評価するためのデバイス、システム、及び方法
JP2018500982A (ja) * 2014-12-08 2018-01-18 コーニンクレッカ フィリップス エヌ ヴェＫｏｎｉｎｋｌｉｊｋｅ Ｐｈｉｌｉｐｓ Ｎ．Ｖ． 異常な心拍波形を検出し生理学的測定計算を行う装置、システム及び方法
JP2019524235A (ja) * 2016-07-14 2019-09-05 コーニンクレッカ フィリップス エヌ ヴェＫｏｎｉｎｋｌｉｊｋｅ Ｐｈｉｌｉｐｓ Ｎ．Ｖ． 血管内の特性測定の品質についてフィードバックする装置、システム及び方法
JP2020531109A (ja) * 2017-08-17 2020-11-05 カーディアックス・アクティーゼルスカブ 心室圧力を推定する方法および装置

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2003525067A (ja) * 1999-03-09 2003-08-26 フローレンス・メディカル・リミテッド Ｃｆｒおよび付加的な臨床的血流力学パラメータを圧力ベースで測定するための方法およびシステム
JP2016508049A (ja) * 2012-12-26 2016-03-17 ヴォルカノ コーポレイションＶｏｌｃａｎｏ Ｃｏｒｐｏｒａｔｉｏｎ マルチモダリティ医療用撮像システムにおける測定および強調
JP2016534770A (ja) * 2013-10-18 2016-11-10 ボルケーノ コーポレイション 充血剤を使用することなく取得された近位及び遠位圧力測定値の最適化によって導管を評価するためのデバイス、システム、及び方法
JP2018500982A (ja) * 2014-12-08 2018-01-18 コーニンクレッカ フィリップス エヌ ヴェＫｏｎｉｎｋｌｉｊｋｅ Ｐｈｉｌｉｐｓ Ｎ．Ｖ． 異常な心拍波形を検出し生理学的測定計算を行う装置、システム及び方法
JP2019524235A (ja) * 2016-07-14 2019-09-05 コーニンクレッカ フィリップス エヌ ヴェＫｏｎｉｎｋｌｉｊｋｅ Ｐｈｉｌｉｐｓ Ｎ．Ｖ． 血管内の特性測定の品質についてフィードバックする装置、システム及び方法
JP2020531109A (ja) * 2017-08-17 2020-11-05 カーディアックス・アクティーゼルスカブ 心室圧力を推定する方法および装置

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