WO2021031355A1 - Procédé et appareil de mesure de tension et de rapport dans une période sans onde et système et support d'enregistrement - Google Patents

Procédé et appareil de mesure de tension et de rapport dans une période sans onde et système et support d'enregistrement Download PDF

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WO2021031355A1
WO2021031355A1 PCT/CN2019/115062 CN2019115062W WO2021031355A1 WO 2021031355 A1 WO2021031355 A1 WO 2021031355A1 CN 2019115062 W CN2019115062 W CN 2019115062W WO 2021031355 A1 WO2021031355 A1 WO 2021031355A1
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blood pressure
instantaneous
pressure
average
waveform
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PCT/CN2019/115062
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English (en)
Chinese (zh)
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刘广志
王之元
曹文彬
徐磊
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苏州润迈德医疗科技有限公司
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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
    • A61B5/02007—Evaluating blood vessel condition, e.g. elasticity, compliance
    • 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
    • A61B5/02108—Measuring pressure in heart or blood vessels from analysis of pulse wave characteristics
    • 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

Definitions

  • the present invention relates to the technical field of coronary artery medicine, and in particular to a method, a device, a coronary artery analysis system and a computer storage medium for measuring the pressure during the non-waveform period and the instantaneous non-waveform ratio.
  • iFR pressure-based index
  • Real-time iFR pressure measurement combined with percutaneous coronary intervention (PCI) or coronary artery analysis system treatment heralds a new paradigm for functional disease assessment, using physiology to prove and guide the best coronary intervention therapy.
  • PCI percutaneous coronary intervention
  • coronary artery analysis system treatment heralds a new paradigm for functional disease assessment, using physiology to prove and guide the best coronary intervention therapy.
  • the ADVISE study found that during a certain period of time during the diastole (called wave-free period), the myocardium is in a state of maximum diastole, the effect of squeezing the blood vessels disappears, and the microvascular resistance in the coronary artery is relatively stable and the lowest It is similar to the average resistance achieved during coronary congestion made by vasodilators such as adenosine, achieving maximum blood perfusion.
  • the present invention provides a method, device, coronary artery analysis system and computer storage medium for measuring the instantaneous average coronary pressure and the instantaneous non-waveform ratio in the non-waveform period, so as to solve the problem that the prior art cannot accurately locate the non-waveform period when the electrocardiogram is lacking. , The problem of not being able to calculate the instantaneous average pressure during the no-wave period.
  • the present application provides a method for measuring the instantaneous coronary artery average pressure during the non-waveform period, including:
  • the blood pressure value of the non-waveform period is extracted, and the instantaneous average coronary pressure at the same time as the blood pressure value is calculated based on the blood pressure value.
  • the method for determining the non-waveform period of the patient's coronary artery includes: the invasive pressure waveform in one cardiac cycle, located in the diastolic phase.
  • the invasive pressure waveform after trace to before the systole is the non-wave phase of the patient's coronary artery.
  • the collecting the real-time blood pressure value of the patient includes: collecting the real-time diastolic blood pressure of the patient.
  • the formula for calculating the instantaneous coronary artery pressure at the same time as the blood pressure value is:
  • P w represents the instantaneous average coronary blood pressure during the non-waveform period
  • P d represents the real-time diastolic blood pressure during the non-waveform period
  • K is a constant between 5 and 20.
  • the K is a constant of 10-12.
  • the collecting the patient's real-time blood pressure value includes: collecting the patient's real-time diastolic blood pressure and real-time systolic blood pressure.
  • the formula for calculating the instantaneous coronary artery average pressure at the same time as the blood pressure value is:
  • P w represents the instantaneous average coronary blood pressure during the non-waveform period
  • P d represents the real-time diastolic blood pressure during the non-waveform period
  • P s represents the patient's real-time systolic blood pressure during the non-waveform period
  • n is a constant from 3 to 10.
  • the n is a constant of 6-8.
  • the formula for calculating the instantaneous coronary artery average pressure at the same time as the blood pressure value is:
  • P w represents the instantaneous average coronary pressure in the no-wave period
  • P m represents the real-time average arterial pressure in the no-wave period
  • P d represents the real-time diastolic blood pressure in the no-wave period
  • P s represents the real-time systolic pressure in the no-wave period
  • a It is a constant between 0.5 and 1.5.
  • the a is a constant between 0.8 and 0.9.
  • this application provides a method for measuring the instantaneous non-waveform ratio, including:
  • the method of measuring the instantaneous coronary artery pressure in the non-waveform period calculate the instantaneous coronary artery average pressure Pd w at the distal end of the stenotic lesion in the non-waveform period and the instantaneous aortic average pressure Pa w in the non-waveform period;
  • the present application provides a device for measuring the instantaneous coronary artery average pressure in the waveformless period, including: a waveformless identification unit, a blood pressure acquisition unit, and an instantaneous coronary artery average pressure measuring unit. Both the identification unit and the blood pressure acquisition unit are connected to the instantaneous coronary artery average pressure measurement unit;
  • the non-waveform identification unit is used to determine the non-waveform period of the patient's coronary artery
  • the blood pressure collection unit is used to collect the blood pressure value of the patient
  • the instantaneous coronary artery average pressure measuring unit is used to extract the blood pressure value of the non-waveform period in the blood pressure acquisition unit according to the determined non-waveform period of the coronary artery of the patient, and calculate the instantaneous value at the same time as the blood pressure value.
  • Mean coronary artery pressure Mean coronary artery pressure.
  • the blood pressure acquisition unit is a diastolic blood pressure acquisition module; the diastolic blood pressure acquisition module is used to acquire the patient's real-time diastolic blood pressure, and the instantaneous coronary artery
  • the blood pressure acquisition unit includes a diastolic blood pressure acquisition module and a systolic blood pressure acquisition module. Both the diastolic blood pressure acquisition module and the systolic blood pressure acquisition module are connected to the instantaneous coronary artery average pressure measurement unit; the diastolic blood pressure acquisition module is used for The real-time diastolic blood pressure of the patient is collected, and the systolic blood pressure acquisition module is used to collect the real-time systolic blood pressure of the patient; the instantaneous coronary artery average pressure measuring unit calculates the instantaneous coronary artery average pressure P w according to the following two formulas:
  • P d represents the real-time diastolic blood pressure in the non-waveform period
  • P s represents the patient's real-time systolic blood pressure in the non-waveform period
  • n is a constant from 3 to 10;
  • P d represents the real-time diastolic blood pressure in the no-wave period
  • P s represents the real-time systolic pressure of the patient in the no-wave period
  • P m represents the real-time average arterial pressure in the no-wave period
  • a is a constant between 0.5 and 1.5.
  • the present application provides a coronary artery analysis system, including: the above-mentioned device for measuring the instantaneous coronary artery average pressure in the non-waveform period.
  • the present application provides a computer storage medium, and when the computer program is executed by a processor, the method for measuring the instantaneous average coronary blood pressure in the non-waveform period is realized.
  • the present application provides a method for measuring the average pressure of coronary artery in the non-waveform period, without the need of electrocardiogram, only the invasive pressure waveform can be used to determine the non-waveform period, and the patient's real-time blood pressure value in the non-waveform period collected from clinical or other means; According to the determined non-waveform period of the patient’s coronary arteries, extract the blood pressure value in the non-waveform period, and calculate the instantaneous coronary artery average pressure in the non-waveform period at the same time as the blood pressure value based on the blood pressure value to solve the problem. There is a problem in the technology that the electrocardiogram must be relied on to measure the instantaneous average coronary pressure during the non-waveform period. The measurement is simpler and more accurate.
  • FIG. 1 is a flowchart of a method for measuring instantaneous coronary artery average pressure in a waveform-free period of the present application
  • Fig. 2 is a flow chart of the method for measuring instantaneous non-waveform ratio of the present application
  • FIG. 3 is a structural block diagram of an embodiment of an apparatus for measuring instantaneous coronary artery average pressure in a waveform-free period according to the present application;
  • FIG. 4 is a structural block diagram of another embodiment of an apparatus for measuring instantaneous coronary artery average pressure in a non-waveform period according to the present application;
  • Figure 5 is an invasive pressure waveform diagram
  • No waveform identification unit 100 blood pressure acquisition unit 200, diastolic blood pressure acquisition module 210, systolic blood pressure acquisition module 220, and instantaneous coronary artery average pressure measurement unit 300.
  • the present application provides a method for measuring the instantaneous coronary artery average pressure during the non-waveform period, which includes:
  • S03 Extract the blood pressure value in the non-waveform period according to the determined non-waveform period of the coronary artery of the patient, and calculate the instantaneous average coronary pressure at the same time as the blood pressure value based on the blood pressure value.
  • the present application provides a method for measuring the average pressure of coronary artery in the non-waveform period, without the need of electrocardiogram, only the invasive pressure waveform can be used to determine the non-waveform period, and the patient's real-time blood pressure value in the non-waveform period collected from clinical or other means; According to the determined non-waveform period of the patient’s coronary arteries, extract the blood pressure value in the non-waveform period, and calculate the instantaneous coronary artery average pressure in the non-waveform period at the same time as the blood pressure value based on the blood pressure value to solve the problem. There is a problem in the technology that the electrocardiogram must be relied on to measure the instantaneous average coronary pressure during the non-waveform period. The measurement is simpler and more accurate.
  • Step S01 includes: collecting the patient's real-time diastolic blood pressure
  • Step S02 includes: the invasive pressure waveform within one cardiac cycle, and the invasive pressure waveform located after the diastolic fluctuation to before the systolic fluctuation is the non-waveform phase of the patient's coronary artery;
  • Step S03 includes: extracting the real-time diastolic blood pressure in the non-waveform period in S02 according to the non-waveform period of the patient's coronary artery determined in S01, and calculate the instantaneous average coronary pressure of the non-waveform period at the same time as the diastolic pressure according to the real-time diastolic blood pressure.
  • the formula is:
  • P w represents the instantaneous phase waveform without coronary artery mean pressure
  • P d represents the waveform of the non-real-time diastolic blood pressure
  • K is a constant of 5 to 20; preferably, K is a constant 10 to 12.
  • Step S01 includes: collecting real-time diastolic blood pressure and real-time systolic blood pressure of the patient;
  • Step S02 includes: the invasive pressure waveform in a cardiac cycle, and the invasive pressure waveform located after the diastolic notch to before the systole is the non-wave phase of the patient's coronary artery;
  • Step S03 includes: according to the blood pressure value, the formula for calculating the instantaneous coronary artery average pressure in the non-waveform period at the same time as the blood pressure value is:
  • P w represents the instantaneous average coronary pressure in the non-waveform period
  • P d represents the real-time diastolic blood pressure in the non-waveform period
  • P s represents the patient's real-time systolic blood pressure during the non-waveform period
  • n is a constant between 3 and 10; preferably, n It is a constant from 6 to 8.
  • Step S01 includes: collecting the patient's real-time blood pressure value includes: collecting the patient's real-time diastolic blood pressure and real-time systolic blood pressure;
  • Step S02 includes: the invasive pressure waveform in one cardiac cycle, and the invasive pressure waveform located after the diastolic dicrotic notch as shown in Fig. 5 from point C to point D before the systolic fluctuation is the non-waveform of the patient’s coronary artery period;
  • Step S03 includes: according to the blood pressure value, the formula for calculating the instantaneous coronary artery average pressure in the non-waveform period at the same time as the blood pressure value is:
  • P w represents the instantaneous average coronary pressure in the no-wave period
  • P m represents the real-time average arterial pressure in the no-wave period
  • P d represents the real-time diastolic blood pressure in the no-wave period
  • P s represents the real-time systolic pressure in the no-wave period
  • a It is a constant between 0.5 and 1.5.
  • a is a constant of 0.8 to 0.9.
  • This application extracts the diastolic pressure P d , the systolic pressure P s and the P w value measured by the guide wire from the clinic in the absence of waveform, as well as the mean arterial pressure P m obtained by calculation, as well as the examples 1 and 2 P w calculated from Example 3 is shown in Table 1, where K in Example 1 is 10, n in Example 2 is 6, and a in Example 3 is 0.9:
  • the instantaneous average coronary artery pressure P w in the non-waveform period calculated in Example 1, Example 2 and Example 3 is basically the same as the P w measured by the guide wire.
  • Example 1 the P w measured in Example 1, Example 2 and Example 3 is compared with the real P w measured by the guide wire, the results are very similar, the accuracy is high, and the stability is high.
  • the electrocardiogram and the pressure waveform are matched, when the two cannot be used together, it is impossible to accurately locate the non-waveform period, resulting in the problem that the instantaneous average pressure of the non-waveform period cannot be calculated; and the order of accuracy is: Example 1> Example 2 >Example 3; the order of stability is: Example 1>Example 2>Example 3.
  • this application provides a method for measuring the instantaneous non-waveform ratio, including:
  • S13 also includes: if N Pd w and Pa w are calculated separately during the no waveform period, then the average value of the N instantaneous coronary artery average pressure Pd w is calculated And the average value of N instantaneous mean aortic pressure Pa w
  • the invasive pressure waveform A represents the real-time change curve of the mean aortic pressure Pa w
  • the invasive pressure waveform B represents the real-time change curve of the coronary mean pressure Pd w
  • the straight line M is the distant stenosis lesion in the no-wave phase.
  • the ordinate of the point is the vertical line; therefore, the intersection point a of the straight line M and the invasive pressure waveform A is the average value of the pressure at the distal end of the stenotic lesion during the non-waveform period
  • this application does not require an electrocardiogram.
  • the wave-free period can be determined by the invasive pressure waveform, and then the iFR value can be obtained through the measurement of diastolic and systolic blood pressure.
  • the measurement is simpler and due to the instantaneous average pressure in the wave-free period
  • the measurement accuracy of iFR is high, so the measurement accuracy of iFR is high.
  • the present application provides a device for measuring the instantaneous coronary artery average pressure in the non-waveform period, including: a waveformless identification unit 100, a blood pressure acquisition unit 200, and an instantaneous coronary artery average pressure measuring unit 300
  • the non-waveform identification unit 100 and the blood pressure acquisition unit 200 are both connected to the instantaneous coronary artery average pressure measurement unit 300;
  • the non-waveform identification unit 100 is used to determine the non-waveform period of the patient’s coronary artery;
  • the blood pressure acquisition unit 200 is used to collect the patient’s blood pressure value ;
  • the instantaneous coronary artery average pressure measuring unit 300 is used to extract the blood pressure value of the waveformless period in the blood pressure acquisition unit 200 according to the determined non-waveform period of the patient’s coronary artery, and calculate the instantaneous coronary artery in the waveformless period at the same time as the blood pressure value.
  • Mean pulse pressure is used to extract the blood pressure value of the waveformless period in the blood
  • the blood pressure acquisition unit 200 includes a diastolic blood pressure acquisition module 210 and a systolic blood pressure acquisition module 220.
  • the diastolic blood pressure acquisition module 210 and the systolic blood pressure acquisition module 220 are both related to the instantaneous coronary average pressure measurement.
  • the unit 300 is connected; the diastolic blood pressure collection module 210 is used to collect the patient's real-time diastolic blood pressure, and the systolic blood pressure collection module 220 is used to collect the patient's real-time systolic blood pressure; the instantaneous coronary average pressure measurement unit 300 calculates the instantaneous coronary average according to the following two formulas Press P w :
  • P d represents the real-time diastolic blood pressure in the non-waveform period
  • P s represents the patient's real-time systolic blood pressure in the non-waveform period
  • n is a constant from 3 to 10;
  • P d represents the real-time diastolic blood pressure in the no-wave period
  • P s represents the real-time systolic pressure of the patient in the no-wave period
  • P m represents the real-time average arterial pressure in the no-wave period
  • a is a constant between 0.5 and 1.5.
  • the present application provides a coronary artery analysis system, including: the above-mentioned device for measuring the instantaneous coronary artery average pressure in the non-waveform period.
  • the present application provides a computer storage medium, and when a computer program is executed by a processor, the method for measuring the instantaneous average coronary blood pressure in the non-waveform period is realized.
  • aspects of the present invention can be implemented as a system, a method, or a computer program product. Therefore, various aspects of the present invention can be specifically implemented in the following forms, namely: complete hardware implementation, complete software implementation (including firmware, resident software, microcode, etc.), or a combination of hardware and software implementations, Here can be collectively referred to as "circuit", "module” or "system”.
  • various aspects of the present invention may also be implemented in the form of a computer program product in one or more computer-readable media, and the computer-readable medium contains computer-readable program code.
  • the implementation of the method and/or system of the embodiments of the present invention may involve performing or completing selected tasks manually, automatically, or a combination thereof.
  • a data processor such as a computing platform for executing multiple instructions.
  • the data processor includes a volatile memory for storing instructions and/or data and/or a non-volatile memory for storing instructions and/or data, for example, a magnetic hard disk and/or Move the media.
  • a network connection is also provided.
  • a display and/or user input device such as a keyboard or mouse is also provided.
  • the computer-readable medium may be a computer-readable signal medium or a computer-readable storage medium.
  • the computer-readable storage medium may be, for example, but not limited to, an electric, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or any combination of the above. More specific examples (non-exhaustive list) of computer-readable storage media would include the following:
  • the computer-readable storage medium can be any tangible medium that contains or stores a program, and the program can be used by or in combination with an instruction execution system, apparatus, or device.
  • the computer-readable signal medium may include a data signal propagated in baseband or as a part of a carrier wave, and computer-readable program code is carried therein. This propagated data signal can take many forms, including but not limited to electromagnetic signals, optical signals, or any suitable combination of the foregoing.
  • the computer-readable signal medium may also be any computer-readable medium other than the computer-readable storage medium.
  • the computer-readable medium can send, propagate or transmit the program for use by or in combination with the instruction execution system, apparatus, or device .
  • the program code contained on the computer-readable medium can be transmitted by any suitable medium, including (but not limited to) wireless, wired, optical cable, RF, etc., or any suitable combination of the above.
  • any combination of one or more programming languages can be used to write computer program codes for performing operations for various aspects of the present invention, including object-oriented programming languages such as Java, Smalltalk, C++, and conventional process programming languages, such as "C" programming language or similar programming language.
  • the program code can be executed entirely on the user's computer, partly on the user's computer, executed as an independent software package, partly on the user's computer and partly executed on a remote computer, or entirely executed on the remote computer or server.
  • the remote computer can be connected to the user's computer through any kind of network including a local area network (LAN) or a wide area network (WAN), or it can be connected to an external computer (for example, using an Internet service provider to pass Internet connection).
  • LAN local area network
  • WAN wide area network
  • Internet service provider for example, using an Internet service provider to pass Internet connection.
  • each block of the flowcharts and/or block diagrams and combinations of blocks in the flowcharts and/or block diagrams can be implemented by computer program instructions.
  • These computer program instructions can be provided to the processors of general-purpose computers, special-purpose computers, or other programmable data processing devices to produce a machine that makes these computer program instructions when executed by the processors of the computer or other programmable data processing devices , A device that implements the functions/actions specified in one or more blocks in the flowchart and/or block diagram is produced.
  • Computer program instructions can also be loaded onto a computer (for example, a coronary artery analysis system) or other programmable data processing equipment to cause a series of operation steps to be performed on the computer, other programmable data processing equipment or other equipment to produce a computer-implemented process , Causing instructions executed on a computer, other programmable device, or other equipment to provide a process for implementing the functions/actions specified in the flowchart and/or one or more block diagrams.
  • a computer for example, a coronary artery analysis system
  • other programmable data processing equipment or other equipment to produce a computer-implemented process
  • Causing instructions executed on a computer, other programmable device, or other equipment to provide a process for implementing the functions/actions specified in the flowchart and/or one or more block diagrams.

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Abstract

La présente invention concerne un procédé et un appareil pour mesurer la tension et le rapport dans une période sans onde et un système et un support d'enregistrement. Le procédé de mesure de la tension coronaire moyenne instantanée dans une période sans onde consiste à : collecter une valeur de tension artérielle en temps réel d'un patient (S01) ; déterminer une période sans onde de l'artère coronaire du patient (S02) ; et extraire la valeur de tension artérielle de la période sans onde en fonction de la période sans onde déterminée de l'artère coronaire du patient et calculer la tension coronaire moyenne instantanée au même moment que la valeur de tension artérielle en fonction de la valeur de tension artérielle (S03). Selon le procédé de mesure de la tension coronaire moyenne instantanée dans la période sans onde, la période sans onde peut être déterminée et la valeur de tension artérielle en temps réel dans la période sans onde du patient peut être collectée cliniquement ou par d'autres manières sans dépendre d'un électrocardiogramme uniquement au moyen de la forme d'onde de tension invasive, c'est-à-dire la tension coronaire moyenne instantanée peut être obtenue au même moment que la valeur de tension artérielle, le problème selon lequel la tension coronaire moyenne instantanée dans la période sans onde peut être mesurée uniquement à l'aide de l'électrocardiogramme dans l'état de la technique est résolu, la mesure est plus simple et la précision est élevée.
PCT/CN2019/115062 2019-08-19 2019-11-01 Procédé et appareil de mesure de tension et de rapport dans une période sans onde et système et support d'enregistrement WO2021031355A1 (fr)

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CN110353645A (zh) * 2019-08-19 2019-10-22 苏州润迈德医疗科技有限公司 测量无波形期压力、比率方法、装置、系统及存储介质

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