CN113951842B

CN113951842B - Diagnostic mode determination system based on blood vessel congestion state

Info

Publication number: CN113951842B
Application number: CN202111223179.3A
Authority: CN
Inventors: 邵小虎; 林佳燕
Original assignee: Insight Lifetech Co Ltd
Current assignee: Insight Lifetech Co Ltd
Priority date: 2020-12-28
Filing date: 2020-12-28
Publication date: 2022-04-29
Anticipated expiration: 2040-12-28
Also published as: CN113951842A; CN113940651A; CN113940651B; CN112617771B; WO2022142518A1; CN112617771A

Abstract

The present application relates to a system for determining a diagnostic mode based on a blood vessel hyperemia status. The system comprises: acquiring a first pressure Pa at the proximal end of the vascular stenosis and a second pressure Pd at the distal end of the vascular stenosis; determining the blood vessel congestion state according to the first pressure Pa and/or the second pressure Pd; if the blood vessel is in a hyperemic state, calculating a first average pressure Pa 'at the proximal end of the vascular stenosis according to the first pressure Pa in the hyperemic state, calculating a second average pressure Pd' at the distal end of the vascular stenosis according to the second pressure Pd in the hyperemic state, and calculating a flow reserve fraction according to the first average pressure Pa 'and the second average pressure Pd'; if the blood vessel is in a non-hyperemic state, a non-hyperemic pressure ratio is calculated based on the first pressure Pa and the second pressure Pd in the non-hyperemic state. The scheme provided by the application does not need manual switching of the diagnosis mode, is favorable for saving operation time, and reduces manpower.

Description

Diagnostic mode determination system based on blood vessel congestion state

Technical Field

The present application relates to the field of medical technology, and in particular, to a system for determining a diagnosis mode based on a blood vessel congestion state.

Background

Fractional Flow Reserve (FFR) is the ratio of the mean pressure in the distal coronary artery to the mean pressure in the proximal aorta of a stenotic coronary artery in the maximal hyperemic state of the myocardium, and is the current clinical gold standard for diagnosing myocardial ischemia. During FFR measurement, it is necessary to inject drugs to bring the blood vessels to a maximum hyperemic state, but some patients are intolerant to the drugs, resulting in limited FFR measurement. Based on this deficiency, the related researchers have proposed a new index for measuring intravascular Pressure without drug congestion, i.e., in a congestion-free state-congestion-free Pressure Ratio (Non-Hyperemic Pressure Ratio, NHPR for short).

In clinical application, the FFR index is used as a diagnosis basis in a hyperemic mode, and the NHPR index is used as a diagnosis basis in a non-hyperemic mode, however, the corresponding mode needs to be manually selected for operation, and in the operation process, labor and time are wasted.

Disclosure of Invention

In order to overcome the problems in the related art, the diagnosis mode determining system based on the blood vessel congestion state is provided, the diagnosis mode can be switched without manual operation, the operation time is saved, and the manpower is reduced.

A first aspect of the present application provides a method for determining a diagnostic mode based on a blood vessel hyperemia status, comprising:

acquiring a first pressure Pa at the proximal end of the vascular stenosis and a second pressure Pd at the distal end of the vascular stenosis;

determining a vascular hyperemia status from the first pressure Pa and/or the second pressure Pd;

if the blood vessel is in a hyperemic state, calculating a first average pressure Pa 'at the proximal end of the vascular stenosis according to the first pressure Pa in the hyperemic state, calculating a second average pressure Pd' at the distal end of the vascular stenosis according to the second pressure Pd in the hyperemic state, and calculating a flow reserve fraction according to the first average pressure Pa 'and the second average pressure Pd';

if the blood vessel is in a non-hyperemic state, a non-hyperemic pressure ratio is calculated based on the first pressure Pa and the second pressure Pd in the non-hyperemic state.

Preferably, said calculating a first mean pressure Pa 'proximal to said vascular stenosis from said first pressure Pa in a hyperemic state and a second mean pressure Pd' distal to said vascular stenosis from said second pressure Pd in a hyperemic state comprises:

determining a cardiac cycle in the hyperemic state according to the fluctuation rule of the first pressure Pa and/or the fluctuation rule of the second pressure Pd in the hyperemic state;

calculating a first mean pressure Pa' proximal to said vascular stenosis from said first pressure Pa of at least one cardiac cycle under hyperemic conditions;

calculating a second mean pressure Pd' distal to said vascular stenosis from said second pressure Pd of said at least one cardiac cycle under hyperemic conditions.

Preferably, the calculating a non-hyperemic pressure ratio from the first pressure Pa and the second pressure Pd in a non-hyperemic state comprises:

determining a cardiac cycle in a non-hyperemic state according to a fluctuation rule of the first pressure Pa and/or a fluctuation rule of the second pressure Pd in the non-hyperemic state;

calculating a ratio of the second pressure Pd to the first pressure Pa in a diastolic phase of at least one cardiac cycle in a non-congestive state to obtain a non-congestive pressure ratio.

Preferably, the method further comprises:

displaying the fractional flow reserve when the blood vessel is in a hyperemic state;

displaying the non-hyperemic pressure ratio when the blood vessel is in a non-hyperemic state.

Preferably, the displaying the fractional flow reserve when the blood vessel is in a hyperemic state comprises:

when the blood flow reserve fraction is located in a preset gray scale interval, acquiring a congestion-free pressure ratio before a congestion state;

displaying the fractional flow reserve and the non-hyperemic pressure ratio prior to the hyperemic state simultaneously.

Preferably, the determining the blood vessel hyperemia status according to the first pressure Pa and/or the second pressure Pd comprises:

calculating a third average pressure of the proximal end of the vascular stenosis from the first pressure Pa

Calculating a fourth mean pressure distal to the stenosis from the second pressure Pd

According to the fourth average voltage

Is equalized with the third stage

The blood vessel congestion state is determined according to the change of the ratio.

inputting the first pressure Pa and/or the second pressure Pd as input data into a sample model for prediction to obtain a prediction result, wherein the sample model is obtained by training a plurality of groups of historical pressure data in a non-hyperemic state and a hyperemic state through a deep learning algorithm;

and determining the blood vessel congestion state according to the prediction result.

A second aspect of the present application provides a system for determining a diagnosis mode based on a blood vessel congestion state, comprising:

the pressure measuring device is used for acquiring a first pressure signal at the near end of the vascular stenosis and acquiring a second pressure signal at the far end of the vascular stenosis;

the host is connected with the pressure measuring device and used for receiving the first pressure signal and the second pressure signal, processing the first pressure signal to obtain a first pressure Pa, and processing the second pressure signal to obtain a second pressure Pd; determining a vascular hyperemia status from the first pressure Pa and/or the second pressure Pd; if the blood vessel is in a hyperemic state, calculating a first average pressure Pa 'at the proximal end of the vascular stenosis according to the first pressure Pa in the hyperemic state, calculating a second average pressure Pd' at the distal end of the vascular stenosis according to the second pressure Pd in the hyperemic state, and calculating a flow reserve fraction according to the first average pressure Pa 'and the second average pressure Pd'; if the blood vessel is in a non-hyperemic state, a non-hyperemic pressure ratio is calculated based on the first pressure Pa and the second pressure Pd in the non-hyperemic state.

Preferably, the host computer includes next machine and host computer, the next machine with the host computer is connected, wherein:

the lower computer is used for receiving the first pressure signal and the second pressure signal, processing the first pressure signal to obtain a first pressure Pa, processing the second pressure signal to obtain a second pressure Pd, and sending the first pressure Pa and the second pressure Pd to the upper computer;

the host computer is used for determining the blood vessel congestion state according to the first pressure Pa and/or the second pressure Pd; if the blood vessel is in a hyperemic state, calculating a first average pressure Pa 'at the proximal end of the vascular stenosis according to the first pressure Pa in the hyperemic state, calculating a second average pressure Pd' at the distal end of the vascular stenosis according to the second pressure Pd in the hyperemic state, and calculating a flow reserve fraction according to the first average pressure Pa 'and the second average pressure Pd'; if the blood vessel is in a non-hyperemic state, a non-hyperemic pressure ratio is calculated based on the first pressure Pa and the second pressure Pd in the non-hyperemic state.

Preferably, the upper computer is further used for displaying the fractional flow reserve when the blood vessel is in a hyperemic state; displaying the non-hyperemic pressure ratio when the blood vessel is in a non-hyperemic state.

Preferably, when the blood vessel is in a hyperemic state, the manner of displaying the fractional flow reserve by the upper computer comprises:

and when the blood flow reserve fraction is located in a preset gray scale interval, the upper computer obtains a non-hyperemic pressure ratio before the hyperemic state and simultaneously displays the blood flow reserve fraction and the non-hyperemic pressure ratio before the hyperemic state.

Preferably, the pressure measuring device comprises a first pressure sensor and a second pressure sensor, and both the first pressure sensor and the second pressure sensor are connected with the host; wherein:

the first pressure sensor is used for acquiring a first pressure signal of the blood vessel stenosis near end and sending the first pressure signal to the host;

and the second pressure sensor is used for acquiring a second pressure signal of the narrow far end of the blood vessel and sending the second pressure signal to the host.

According to the technical scheme provided by the application, the blood vessel congestion state is identified by analyzing the fluctuation condition of the first pressure Pa at the proximal end of the blood vessel stenosis and/or the fluctuation condition of the second pressure Pd at the distal end of the blood vessel stenosis; when the blood vessel is in a hyperemic state, calculating the ratio of a first average pressure Pa 'at the proximal end of the angiostenosis and a second average pressure Pd' at the distal end of the angiostenosis under the hyperemic state to obtain a Fractional Flow Reserve (FFR); when the blood vessel is in a non-hyperemic state, the non-hyperemic pressure ratio NHPR value is calculated by the first pressure Pa and the second pressure Pd in the non-hyperemic state. Compared with the existing manual switching diagnosis mode, the blood vessel hyperemia state can be intelligently identified by analyzing the blood vessel pressure data, the diagnosis parameters can be automatically switched to the corresponding mode according to the identification result, manual operation is not needed, when the method is applied to clinics, the operation time can be saved, and the manpower is reduced.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the application.

Drawings

The foregoing and other objects, features and advantages of the application will be apparent from the following more particular descriptions of exemplary embodiments of the application, as illustrated in the accompanying drawings wherein like reference numbers generally represent like parts throughout the exemplary embodiments of the application.

FIG. 1 is a flow chart illustrating a method for determining a diagnostic mode based on a blood vessel hyperemia status according to an embodiment of the present disclosure;

FIG. 2 is a waveform diagram illustrating pressure data according to an embodiment of the present application;

FIG. 3 is a graphical representation of pressure data waveforms for a non-hyperemic state and a hyperemic state according to an embodiment of the present disclosure;

FIG. 4 is a schematic structural diagram of a device for determining a diagnosis mode based on a blood vessel congestion state according to an embodiment of the present application;

fig. 5 is a schematic structural diagram of an electronic device according to an embodiment of the present application;

fig. 6 is a schematic structural diagram of a diagnosis mode determination system based on a blood vessel congestion state according to an embodiment of the present application.

Detailed Description

Preferred embodiments of the present application will be described in more detail below with reference to the accompanying drawings. While the preferred embodiments of the present application are shown in the drawings, it should be understood that the present application may be embodied in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art.

The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. As used in this application and the appended claims, the singular forms "a", "an", and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It should also be understood that the term "and/or" as used herein refers to and encompasses any and all possible combinations of one or more of the associated listed items.

It should be understood that although the terms "first," "second," "third," etc. may be used herein to describe various information, these information should not be limited to these terms. These terms are only used to distinguish one type of information from another. For example, first information may also be referred to as second information, and similarly, second information may also be referred to as first information, without departing from the scope of the present application. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of the present application, "a plurality" means two or more unless specifically limited otherwise. The technical solutions of the embodiments of the present application are described in detail below with reference to the accompanying drawings.

The embodiment of the application provides a diagnosis mode determination method based on a blood vessel congestion state. As shown in fig. 1, the method may include the steps of:

s110, acquiring a first pressure Pa at the proximal end of the vascular stenosis and a second pressure Pd at the distal end of the vascular stenosis.

In the embodiment of the present application, the interventional catheter technique can be used to measure the pressure in the blood vessel for determining the pathological condition of the blood vessel of the patient, such as stenosis. In particular, a pressure measuring device, such as a MEMS (Micro-Electro-Mechanical System) pressure sensor, a fiber optic pressure sensor, or the like, may be integrated on the interventional catheter. The pressure measuring device may include a first pressure sensor and a second pressure sensor, wherein the first pressure sensor may be disposed outside the human body, and may sense the pressure of blood introduced from a guide catheter (hollow) inserted into the human body. The head end of the guide catheter is located at the proximal end of the angiostenosis, and the tail end of the guide catheter is arranged outside the body and connected with the first pressure sensor, so that the first pressure sensor can measure pressure data of the proximal end of the angiostenosis. The second pressure sensor may be disposed in the body and may be integrated at a tip of a pressure microcatheter that is passed through the guiding catheter and into the distal end of the stenotic lesion, such that the second pressure sensor may measure pressure data of the distal end of the stenotic lesion. It is understood that the first pressure sensor and the second pressure sensor may be subjected to a zero calibration process before the first pressure sensor and the second pressure sensor measure the blood vessel pressure, respectively. The pressure balance can be carried out on the two pressure sensors, specifically, when the second pressure sensor reaches the head end of the guide conduit, the pressure of the first pressure sensor is used as a reference, and the second pressure sensor is adjusted, so that the two pressure sensors keep a uniform pressure reference, the measurement error between the two pressure sensors can be eliminated, and the accuracy of the measurement result can be improved.

In this embodiment, the blood vessel may be a coronary artery, the proximal end of the stenosis may be a coronary ostium, and the distal end of the stenosis may be a distal end of the stenosis and a location away from the coronary ostium. Of course, the possibility of being applicable to other vessels, such as peripheral vessels, is not excluded.

In step S110, the pressure data of the proximal end of the stenosis of the blood vessel may be acquired in real time by using a first pressure sensor, and the pressure data of the distal end of the stenosis of the blood vessel may be acquired in real time by using a second pressure sensor, and the acquired data may be respectively subjected to analog-to-digital conversion (converting an analog signal acquired by the pressure sensor into a digital electrical signal), pressure calculation (converting the digital electrical signal into a pressure value), and finally converted into the first pressure Pa and the second pressure Pd.

In step S110, the first pressure Pa and the second pressure Pd may also be directly obtained from a local storage device or a network. Specifically, the first pressure Pa obtained by converting the pressure data acquired by the first pressure sensor may be stored in a data linked list, where the data linked list uses time as an index and uses time and real-time pressure values as key value pairs for storage. Similarly, the second pressure Pd obtained by converting the pressure data collected by the second pressure sensor may be stored in the above manner. The data link list can be stored to a local storage device or a network terminal. And taking the time as an index value, and acquiring corresponding pressure values from the data linked list to obtain a first pressure Pa and a second pressure Pd.

And S120, determining the blood vessel congestion state according to the first pressure Pa and/or the second pressure Pd.

In the embodiment of the present application, as shown in fig. 2, the first pressure Pa at different times may generate a pressure waveform curve, and the second pressure Pd at the same time may also generate a pressure waveform curve. Wherein, fig. 2 includes two groups of waveform diagrams, the upper group of waveform diagrams are a waveform curve of the first pressure Pa, a waveform curve of the second pressure Pd, and a third average pressure obtained by summing and averaging the first pressure Pa at different times

And a fourth average pressure obtained by summing and averaging the second pressures Pd at different times

Wherein the abscissa represents time in seconds; the ordinate represents the pressure value in mm hg. The waveform diagram at the upper part in the next group of waveform diagrams represents the real-time pressure difference between the first pressure Pa and the second pressure Pd, and the waveform diagram at the lower part represents the fourth average pressure

Is equalized with the third stage

The ratio of (a) to (b). Assuming FIG. 2 is the corresponding waveform diagram under the maximal hyperemia state, the fourth average voltage

Is equalized with the third stage

The ratio of (d) is the FFR value.

As can be seen from fig. 2, the waveform curves of the first pressure Pa and the second pressure Pd substantially coincide, and therefore, whether the blood vessel is in the maximum hyperemia state can be determined according to the waveform curve change of the first pressure Pa and/or the waveform curve change of the second pressure Pd.

In an alternative embodiment, the specific embodiment of determining the blood vessel congestion state according to the first pressure Pa and/or the second pressure Pd in step S120 may include the following steps:

calculating a third mean pressure of the proximal end of the vascular stenosis from the first pressure Pa

According to the fourth average pressure

Is equalized with the third stage

Specifically, a third average pressure may be obtained by summing and averaging the first pressures Pa obtained by the real-time measurement of the first pressure sensor

And summing and averaging the second pressures Pd obtained by real-time measurement of the second pressure sensor to obtain a fourth average pressure

Then according to the fourth average pressure

Is equalized with the third stage

The change of the ratio of (a) to (b) identifies the presence or absence of congestion in the blood vessel. For example, as shown in FIG. 3, a fourth leveling voltage

Is equalized with the third stage

The ratio of (A) is stable for a period of time (stage (I): the stable period in the non-congestion state) and then the ratio is reduced (stage (II): the fluctuating period in the congestion state), then the ratio is reduced at the beginning, and the injection of the medicine (such as adenosine) is considered to be started to enable the blood vessel to reach the maximum congestion state. After a certain period of time, the hyperemic state enters a stable phase (phase III: stable phase in the hyperemic state)) When the injection of the medicine is stopped, the average pressure ratio starts to rise again (stage iv: a transition from a hyperemic state to a non-hyperemic state). When the average pressure ratio remains unchanged, the blood vessel can be considered to be in a non-hyperemic state; when the mean pressure ratio exhibits the above-mentioned change pattern, it is considered that the blood vessel is in a hyperemic state after the mean pressure ratio decreases and becomes stable.

inputting the first pressure Pa and/or the second pressure Pd as input data into a sample model for prediction to obtain a prediction result, wherein the sample model can be obtained by training a plurality of groups of historical pressure data in a non-hyperemic state and a hyperemic state through a deep learning algorithm;

Specifically, based on a machine learning mode, a plurality of groups of historical pressure data are manually calibrated to be divided into two states of hyperemia and non-hyperemia, and then training and fitting are performed through a multilayer neural network, so that the characteristic difference of hyperemia and non-hyperemia waveforms is learned, and a sample model is obtained. The waveforms of the first pressure Pa and/or the second pressure Pd are used as input data and input into a sample model obtained through training for prediction and comparison, so that the judgment of the hyperemia state and the non-hyperemia state is completed, and the identification of the blood vessel hyperemia state is further realized.

It is understood that one of the above two methods can be used to intelligently identify the blood vessel congestion state, and the two methods can be combined to intelligently identify the blood vessel congestion state, which is not limited herein.

S130, if the blood vessel is in a hyperemic state, calculating a first average pressure Pa 'at the proximal end of the stenosis of the blood vessel according to the first pressure Pa in the hyperemic state, calculating a second average pressure Pd' at the distal end of the stenosis of the blood vessel according to the second pressure Pd in the hyperemic state, and calculating a fractional flow reserve according to the first average pressure Pa 'and the second average pressure Pd'.

As shown in fig. 3, since the first pressure Pa and the second pressure Pd in the hyperemic state both change from before hyperemia, the tendency of the pressure after hyperemia is decreased from that before hyperemia. The first pressure Pa at a time (e.g., stage c) after the blood filling level has settled may be averaged to obtain a first average pressure Pa 'proximal to the stenosis, and the second pressure Pd at the same time may be averaged to obtain a second average pressure Pd' distal to the stenosis. And calculating the ratio of the second average pressure Pd 'to the first average pressure Pa' to obtain the fractional flow reserve FFR value.

In an alternative embodiment, the step S130 of calculating a first mean pressure Pa 'proximal to the stenosis from the first pressure Pa in the hyperemic state, and calculating a second mean pressure Pd' distal to the stenosis from the second pressure Pd in the hyperemic state may include:

calculating a first mean pressure Pa' proximal to the stenosis of the vessel from the first pressure Pa of the at least one cardiac cycle in the hyperemic state;

a second mean pressure Pd' distal to the stenosis is calculated from the second pressure Pd of the at least one cardiac cycle in a hyperemic state.

Specifically, in order to make the value of the average pressure more accurate, the average pressure may be calculated by using the pressure value of at least one cardiac cycle. Since not only the pressure values of the blood vessels before and after congestion will change, the cardiac cycle may also change, e.g., the post-congestion cardiac cycle is less than the pre-congestion cardiac cycle. In order to make the calculated FFR value more accurate, the cardiac cycle in the hyperemia state may be determined according to the fluctuation law of the first pressure Pa and/or the fluctuation law of the second pressure Pd within a period of time after the hyperemia state is stable, the first pressure Pa in at least one cardiac cycle is taken to sum and average to obtain a first average pressure Pa ', the second pressure Pd in the same cardiac cycle is taken to sum and average to obtain a second average pressure Pd', and the ratio of the second average pressure Pd 'to the first average pressure Pa' is taken as the FFR value, that is, FFR is Pd '/Pa'.

And S140, if the blood vessel is in a non-hyperemic state, calculating a non-hyperemic pressure ratio according to the first pressure Pa and the second pressure Pd in the non-hyperemic state.

In an alternative embodiment, if the blood vessel is in the non-hyperemic state in step S140, the specific embodiment of calculating the non-hyperemic pressure ratio according to the first pressure Pa and the second pressure Pd in the non-hyperemic state may include the following steps:

determining a cardiac cycle in the non-hyperemic state according to the fluctuation rule of the first pressure Pa and/or the fluctuation rule of the second pressure Pd in the non-hyperemic state;

and calculating the ratio of the second pressure Pd in the diastole to the first pressure Pa in at least one cardiac cycle in the non-hyperemic state to obtain the non-hyperemic pressure ratio.

As shown in fig. 2, since the fluctuation law of the first pressure Pa and the fluctuation law of the second pressure Pd are very similar, one of the pressure waveforms may be selected to determine the cardiac cycle, or both of the pressure waveforms may be selected together to determine the cardiac cycle. The cardiac cycle includes a systolic phase, in which pressure is elevated, and a diastolic phase, in which pressure is reduced. The non-congestive pressure ratio NHPR value can be obtained by taking the first pressure Pa and the second pressure Pd at a time within the diastolic period of at least one cardiac cycle in the non-congestive state, preferably, the first pressure Pa and the second pressure Pd at a time period (wave-free period) from 25% of the beginning of the diastolic period to 5ms before the end of the diastolic period, calculating the ratio of the second pressure Pd at the wave-free period to the first pressure Pa, and averaging.

In addition, a plateau in each cardiac cycle may also be calculated, wherein a plateau may be a period of time during which the ratio of the second pressure Pd to the first pressure Pa is derived over time, the derivative being stable and tending to 0. The plateau phase is also typically in the diastolic phase of the cardiac cycle. The NHPR value may be obtained by averaging the ratio of the second pressure Pd to the first pressure Pa during the plateau of at least one cardiac cycle.

In an alternative embodiment, the method shown in fig. 1 may further include the steps of:

displaying fractional flow reserve when the blood vessel is in a hyperemic state;

when the blood vessel is in a non-hyperemic state, a non-hyperemic pressure ratio is displayed.

Specifically, when the blood vessel is in a hyperemic state, the FFR diagnosis mode may be entered, and after the FFR value is calculated, the FFR value may be output and displayed, so that relevant personnel (such as researchers and doctors) may determine the myocardial ischemia condition of the patient by using the FFR value as a diagnosis basis, and further determine the treatment plan. For example, if the FFR value is less than 0.75, manual intervention may be used for revascularization, such as stent placement; if the FFR value is greater than 0.8, drug conservation treatment can be performed.

When the blood vessel is in a non-hyperemic state, the NHPR diagnosis mode can be entered, and after the NHPR value is calculated, the NHPR value can be output and displayed, so that relevant personnel can determine the myocardial ischemia condition of a patient by taking the NHPR value as a diagnosis basis, and further determine a treatment scheme. For example, if the NHPR value is less than 0.9, manual intervention may be performed; if the NHPR value is greater than 0.9, drug conservation therapy may be used.

In an alternative embodiment, the specific embodiment of displaying fractional flow reserve when the blood vessel is in a hyperemic state may further comprise the steps of:

when the blood flow reserve fraction is within a preset gray scale interval, acquiring a congestion-free pressure ratio before a congestion state;

the fractional flow reserve and the non-hyperemic pressure ratio prior to the hyperemic state are also displayed.

Wherein, the gray scale interval of FFR value is generally set to be between 0.75 and 0.8. When the FFR value is within the preset gray scale interval, the NHPR value may be combined together to determine a diagnostic scheme. The NHPR value before congestion can be obtained and enters a dual-mode display mode, namely the FFR value and the NHPR value are displayed at the same time, so that the NHPR value is used as auxiliary diagnosis information, and related personnel can obtain a treatment scheme better. For example, if the FFR value is between 0.75 and 0.8 and the NHPR value is less than 0.9, manual intervention treatment can be carried out; if the FFR value is between 0.75 and 0.8 and the NHPR value is more than 0.9, the medicine conservation treatment can be carried out. It is understood that the NHPR value calculated within a certain time after the completion of the blood filling (e.g., after stopping the injection of adenosine) may be obtained as the auxiliary diagnostic information, which is not limited herein.

In an alternative embodiment, the specific embodiment of displaying the decongested pressure ratio when the blood vessel is in a decongested state may further comprise the steps of:

when the non-congestion pressure ratio is within a preset critical interval, obtaining a blood flow reserve fraction in a congestion state;

the non-hyperemic pressure ratio and the fractional flow reserve in the hyperemic state are also displayed.

Specifically, when the calculated NHPR value is in the critical region in the non-congestive mode, the FFR value in the congestive state may be combined to output the diagnosis information comprehensively. For example, if the critical range of the NHPR value is 0.86-0.93, when the NHPR value is between 0.86-0.93 and the FFR value is less than 0.75, the manual intervention treatment can be performed; when the NHPR value is between 0.86 and 0.93 and the FFR value is more than 0.8, the medicine conservation treatment can be carried out.

In summary, the embodiment of the present application identifies the blood vessel congestion state by analyzing the fluctuation condition of the first pressure Pa at the proximal end of the blood vessel stenosis and/or the fluctuation condition of the second pressure Pd at the distal end of the blood vessel stenosis; when the blood vessel is in a hyperemic state, calculating the ratio of a first average pressure Pa 'at the proximal end of the angiostenosis and a second average pressure Pd' at the distal end of the angiostenosis under the hyperemic state to obtain a Fractional Flow Reserve (FFR); when the blood vessel is in a non-hyperemic state, the non-hyperemic pressure ratio NHPR value is calculated by the first pressure Pa and the second pressure Pd in the non-hyperemic state. Compared with the existing manual switching diagnosis mode, the blood vessel hyperemia state can be intelligently identified by analyzing the blood vessel pressure data, the diagnosis parameters can be automatically switched to the corresponding mode according to the identification result, manual operation is not needed, when the method is applied to clinics, the operation time can be saved, and the manpower is reduced. In addition, the method and the device support dual-mode display, and can comprehensively output auxiliary diagnosis information aiming at the FFR diagnosis critical area and the NHPR diagnosis critical area, so that a doctor can be better guided to determine a treatment scheme.

The embodiment of the application also provides a diagnosis mode determination device based on the blood vessel congestion state, which can be used for executing the diagnosis mode determination method based on the blood vessel congestion state provided by the embodiment. As shown in fig. 4, the apparatus may include:

a pressure obtaining module 41, configured to obtain a first pressure Pa at a proximal end of the vascular stenosis and a second pressure Pd at a distal end of the vascular stenosis;

a state determination module 42 for determining a vascular hyperemia state based on the first pressure Pa and/or the second pressure Pd;

a first calculating module 43, configured to calculate a first average pressure Pa 'proximal to the stenosis of the blood vessel according to the first pressure Pa in the hyperemic state and a second average pressure Pd' distal to the stenosis of the blood vessel according to the second pressure Pd in the hyperemic state when the state determining module 42 determines that the blood vessel is in the hyperemic state, and calculate a flow reserve fraction according to the first average pressure Pa 'and the second average pressure Pd';

a second calculating unit 44, configured to calculate a non-hyperemic pressure ratio according to the first pressure Pa and the second pressure Pd in the non-hyperemic state when the state determining module 42 determines that the blood vessel is in the non-hyperemic state.

Alternatively, the manner in which the first calculation module 43 calculates the first mean pressure Pa 'proximal to the vascular stenosis from the first pressure Pa in the hyperemic state, and calculates the second mean pressure Pd' distal to the vascular stenosis from the second pressure Pd in the hyperemic state may include:

the first calculation module 43 determines the cardiac cycle in the congestive state based on the fluctuation law of the first pressure Pa and/or the fluctuation law of the second pressure Pd in the congestive state, and calculates a first average pressure Pa 'proximal to the vascular stenosis based on the first pressure Pa of at least one cardiac cycle in the congestive state, and a second average pressure Pd' distal to the vascular stenosis based on the second pressure Pd of the at least one cardiac cycle in the congestive state.

Optionally, the second calculating unit 44 may be specifically configured to determine a cardiac cycle in the non-congestive state according to a fluctuation rule of the first pressure Pa and/or a fluctuation rule of the second pressure Pd in the non-congestive state, and calculate a ratio of the second pressure Pd in the diastolic period to the first pressure Pa in at least one cardiac cycle in the non-congestive state, so as to obtain the non-congestive pressure ratio.

Optionally, the apparatus shown in fig. 4 may further include a first display module and a second display module (not shown in the figure), specifically:

the first display module is used for displaying the fractional flow reserve when the blood vessel is in a hyperemic state;

and the second display module is used for displaying the non-hyperemic pressure ratio when the blood vessel is in a non-hyperemic state.

Optionally, the first display module may display the fractional flow reserve when the blood vessel is in a hyperemic state in a manner including:

the first display module obtains a congestion-free pressure ratio before a congestion state when the blood flow reserve fraction is within a preset gray scale interval; the fractional flow reserve and the non-hyperemic pressure ratio prior to the hyperemic state are also displayed.

Optionally, the manner of displaying the non-hyperemic pressure ratio when the blood vessel is in the non-hyperemic state by the second display module may include:

the second display module acquires a blood flow reserve fraction in a congestion state when the non-congestion pressure ratio is within a preset critical interval; the non-hyperemic pressure ratio and the fractional flow reserve in the hyperemic state are also displayed.

Optionally, the state determination module 42 may be specifically configured to calculate a third mean pressure proximal to the stenosis of the vessel from the first pressure Pa

According to the fourth average pressure

Is equalized with the third stage

Of a ratio ofAnd (4) changing the condition, and determining the blood vessel congestion state.

Optionally, the state determining module 42 may be specifically configured to input the first pressure Pa and/or the second pressure Pd as input data into the sample model for prediction, obtain a prediction result, and determine the blood vessel congestion state according to the prediction result; the sample model is obtained by training a deep learning algorithm by using multiple groups of historical pressure data in a non-hyperemic state and a hyperemic state.

With regard to the apparatus in the above-described embodiment, the specific manner in which each module performs the operation has been described in detail in the embodiment related to the method, and will not be elaborated here.

By implementing the device shown in fig. 4, the blood vessel congestion state can be intelligently identified by analyzing the blood vessel pressure data, and the diagnosis parameters can be automatically switched to the corresponding mode according to the identification result, so that manual operation is not needed, and when the device is clinically applied, the operation time can be saved, and the labor force can be reduced. In addition, the device also supports dual-mode display, auxiliary diagnosis information can be comprehensively output aiming at the FFR diagnosis critical area and the NHPR diagnosis critical area, and doctors can be better guided to determine treatment schemes.

The embodiment of the present application further provides an electronic device, which can be used to execute the method for determining a diagnosis mode based on a blood vessel congestion state provided in the foregoing embodiment. Specifically, as shown in fig. 5, the electronic device 500 may include: at least one processor 501, memory 502, at least one communication interface 503, and the like. Wherein the components may be communicatively coupled via one or more communication buses 504. Those skilled in the art will appreciate that the configuration of the electronic device 500 shown in fig. 5 is not intended to limit embodiments of the present application, and may be a bus or star configuration, may include more or fewer components than those shown, may combine certain components, or may be arranged in different components.

Wherein:

the Processor 501 may be a Central Processing Unit (CPU), other general purpose Processor, a Digital Signal Processor (DSP), an Application Specific Integrated Circuit (ASIC), a Field Programmable Gate Array (FPGA) or other Programmable logic device, discrete Gate or transistor logic device, discrete hardware component, etc. A general purpose processor may be a microprocessor or the processor may be any conventional processor or the like.

The memory 502 may include various types of storage units, such as system memory, Read Only Memory (ROM), and permanent storage. Wherein the ROM may store static data or instructions for the processor 501 or other modules of the computer. The persistent storage device may be a read-write storage device. The persistent storage may be a non-volatile storage device that does not lose stored instructions and data even after the computer is powered off. In some embodiments, the persistent storage device employs a mass storage device (e.g., magnetic or optical disk, flash memory) as the persistent storage device. In other embodiments, the permanent storage may be a removable storage device (e.g., floppy disk, optical drive). The system memory may be a read-write memory device or a volatile read-write memory device, such as a dynamic random access memory. The system memory may store instructions and data that some or all of the processors require at runtime. In addition, the memory 502 may include any combination of computer-readable storage media, including various types of semiconductor memory chips (DRAM, SRAM, SDRAM, flash memory, programmable read-only memory), magnetic and/or optical disks, as well. In some embodiments, memory 502 may include a removable storage device that is readable and/or writable, such as a Compact Disc (CD), a digital versatile disc read only (e.g., DVD-ROM, dual layer DVD-ROM), a Blu-ray disc read only, an ultra-dense disc, a flash memory card (e.g., SD card, min SD card, Micro-SD card, etc.), a magnetic floppy disk, or the like. Computer-readable storage media do not contain carrier waves or transitory electronic signals transmitted by wireless or wired means.

The communication interface 503 may include a wired communication interface, a wireless communication interface, etc., and may be used to communicatively interact with a pressure sensor or other device.

The memory 502 has stored thereon executable code, which when processed by the processor 501, may cause the processor 501 to perform some or all of the steps of the above-described method for determining a diagnostic mode based on a blood vessel hyperemia status.

The embodiment of the application also provides a diagnosis mode determining system based on the blood vessel congestion state, which can be used for executing the diagnosis mode determining method based on the blood vessel congestion state provided by the embodiment. As shown in fig. 6, the system may include at least: pressure measurement device 10 and host 20, wherein:

a pressure measuring device 10 for acquiring a first pressure signal proximal to the vascular stenosis and a second pressure signal distal to the vascular stenosis;

the host 20 is connected with the pressure measurement device 10 and is used for receiving the first pressure signal and the second pressure signal, processing the first pressure signal to obtain a first pressure Pa, and processing the second pressure signal to obtain a second pressure Pd; determining the blood vessel congestion state according to the first pressure Pa and/or the second pressure Pd; if the blood vessel is in a hyperemic state, calculating a first average pressure Pa 'at the proximal end of the vascular stenosis according to the first pressure Pa in the hyperemic state, calculating a second average pressure Pd' at the distal end of the vascular stenosis according to the second pressure Pd in the hyperemic state, and calculating a flow reserve fraction according to the first average pressure Pa 'and the second average pressure Pd'; if the blood vessel is in a non-hyperemic state, a non-hyperemic pressure ratio is calculated based on the first pressure Pa and the second pressure Pd in the non-hyperemic state.

Optionally, the host 20 may include a lower computer 21 and an upper computer 22, the lower computer 21 is connected to the upper computer 22, wherein:

the lower computer 21 is used for receiving the first pressure signal and the second pressure signal, processing the first pressure signal to obtain a first pressure Pa, processing the second pressure signal to obtain a second pressure Pd, and sending the first pressure Pa and the second pressure Pd to the upper computer 22;

the upper computer 22 is used for determining the blood vessel congestion state according to the first pressure Pa and/or the second pressure Pd; if the blood vessel is in a hyperemic state, calculating a first average pressure Pa 'at the proximal end of the vascular stenosis according to the first pressure Pa in the hyperemic state, calculating a second average pressure Pd' at the distal end of the vascular stenosis according to the second pressure Pd in the hyperemic state, and calculating a flow reserve fraction according to the first average pressure Pa 'and the second average pressure Pd'; if the blood vessel is in a non-hyperemic state, a non-hyperemic pressure ratio is calculated based on the first pressure Pa and the second pressure Pd in the non-hyperemic state.

Optionally, the determining, by the upper computer 22, the blood vessel congestion state according to the first pressure Pa and/or the second pressure Pd may include:

the upper computer 22 calculates a third average pressure of the near end of the angiostenosis according to the first pressure Pa

According to the fourth average pressure

Is equalized with the third stage

the upper computer 22 inputs the first pressure Pa and/or the second pressure Pd as input data into the sample model for prediction to obtain a prediction result, and determines the blood vessel congestion state according to the prediction result; the sample model is obtained by training a deep learning algorithm by using multiple groups of historical pressure data in a non-hyperemic state and a hyperemic state.

Alternatively, the manner in which the upper computer 22 calculates the first average pressure Pa 'proximal to the vascular stenosis from the first pressure Pa in the hyperemic state, and calculates the second average pressure Pd' distal to the vascular stenosis from the second pressure Pd in the hyperemic state may include:

the upper computer 22 determines a cardiac cycle in the hyperemia state according to the fluctuation rule of the first pressure Pa and/or the fluctuation rule of the second pressure Pd in the hyperemia state; calculating a first mean pressure Pa' proximal to the stenosis of the vessel from the first pressure Pa of the at least one cardiac cycle in the hyperemic state; a second mean pressure Pd' distal to the stenosis is calculated from the second pressure Pd of the at least one cardiac cycle in a hyperemic state.

Alternatively, the manner of calculating the non-hyperemic pressure ratio by the upper computer 22 according to the first pressure Pa and the second pressure Pd in the non-hyperemic state may include:

the upper computer 22 determines a cardiac cycle in the non-hyperemic state according to the fluctuation rule of the first pressure Pa and/or the fluctuation rule of the second pressure Pd in the non-hyperemic state; and calculating the ratio of the second pressure Pd in the diastole to the first pressure Pa in at least one cardiac cycle in the non-hyperemic state to obtain the non-hyperemic pressure ratio.

Specifically, the lower computer 21 may include an analog-to-digital conversion module, a pressure conversion module, and a first communication module. The analog-to-digital conversion module is used for converting the first pressure signal and the second pressure signal from analog signals into digital electric signals. The pressure conversion module is used for converting the digital electric signal converted by the analog-to-digital conversion module into a corresponding pressure value, so that a first pressure Pa and a second pressure Pd are obtained. And then the first communication module sends the first pressure Pa and the second pressure Pd to the upper computer 22.

The upper computer 22 may include a second communication module, a storage module, and a processing module. The second communication module is connected with the first communication module and used for receiving the first pressure Pa and the second pressure Pd. The storage module is used for storing the first pressure Pa, the second pressure Pd and other data. The processing module is used for determining the blood vessel congestion state according to the first pressure Pa and/or the second pressure Pd, calculating the blood flow reserve fraction in the congestion state, and calculating the congestion-free pressure ratio in the congestion-free state.

Optionally, the upper computer 22 may be further configured to display the fractional flow reserve when the blood vessel is in a hyperemic state; when the blood vessel is in a non-hyperemic state, a non-hyperemic pressure ratio is displayed.

Optionally, when the blood vessel is in a hyperemic state, the upper computer 22 may display the fractional flow reserve in a manner including:

when the blood flow reserve fraction is within the preset gray scale interval, the upper computer 22 obtains the non-hyperemic pressure ratio before the hyperemic state, and displays the blood flow reserve fraction and the non-hyperemic pressure ratio before the hyperemic state.

Optionally, when the blood vessel is in a non-hyperemic state, the manner of displaying the non-hyperemic pressure ratio by the upper computer 22 may include:

when the non-congestion pressure ratio is within the preset critical interval, the upper computer 22 obtains the fractional flow reserve in the congestion state, and displays the non-congestion pressure ratio and the fractional flow reserve in the congestion state.

Specifically, the upper computer 22 may further include a display module, which may be configured to display different diagnostic parameters in different modes, and may also support dual-mode display, i.e., displaying the FFR value and the NHPR value at the same time. In addition, the display module can also be used for displaying real-time waveforms of the first pressure Pa, the second pressure Pd, Pd/Pa and the like.

Optionally, the pressure measuring device 10 may include a first pressure sensor 11 and a second pressure sensor 12, and both the first pressure sensor 11 and the second pressure sensor 12 are connected to the host 20; wherein:

the first pressure sensor 11 is used for acquiring a first pressure signal of the proximal end of the vascular stenosis and sending the first pressure signal to the host 20;

and the second pressure sensor 12 is used for acquiring a second pressure signal at the far end of the vascular stenosis and sending the second pressure signal to the host 20.

The system shown in fig. 6 can intelligently identify the blood vessel congestion state, display different diagnosis parameters in different states, does not need manual operation, and is beneficial to saving operation time and reducing manpower when applied to clinic. In addition, the system can also support the dual-mode operation of FFR and NHPR, the FFR and the NHPR can be used as the diagnosis result which is mutually supplemented, and when the FFR is in a critical interval, the NHPR value can be referred to, so that the intraoperative operation can be guided more accurately.

The aspects of the present application have been described in detail hereinabove with reference to the accompanying drawings. In the above embodiments, the descriptions of the respective embodiments have respective emphasis, and for parts that are not described in detail in a certain embodiment, reference may be made to related descriptions of other embodiments. Those skilled in the art should also appreciate that the acts and modules referred to in the specification are not necessarily required in the present application. In addition, it can be understood that the steps in the method of the embodiment of the present application may be sequentially adjusted, combined, and deleted according to actual needs, and the modules in the device of the embodiment of the present application may be combined, divided, and deleted according to actual needs.

Furthermore, the method according to the present application may also be implemented as a computer program or computer program product comprising computer program code instructions for performing some or all of the steps of the above-described method of the present application.

Alternatively, the present application may also be embodied as a non-transitory machine-readable storage medium (or computer-readable storage medium, or machine-readable storage medium) having stored thereon executable code (or a computer program, or computer instruction code) which, when executed by a processor of an electronic device (or electronic device, server, etc.), causes the processor to perform part or all of the various steps of the above-described method according to the present application.

Those of skill would further appreciate that the various illustrative logical blocks, modules, circuits, and algorithm steps described in connection with the applications disclosed herein may be implemented as electronic hardware, computer software, or combinations of both.

The flowchart and block diagrams in the figures illustrate the architecture, functionality, and operation of possible implementations of systems and methods according to various embodiments of the present application. In this regard, each block in the flowchart or block diagrams may represent a module, segment, or portion of code, which comprises one or more executable instructions for implementing the specified logical function(s). It should also be noted that, in some alternative implementations, the functions noted in the block may occur out of the order noted in the figures. For example, two blocks shown in succession may, in fact, be executed substantially concurrently, or the blocks may sometimes be executed in the reverse order, depending upon the functionality involved. It will also be noted that each block of the block diagrams and/or flowchart illustration, and combinations of blocks in the block diagrams and/or flowchart illustration, can be implemented by special purpose hardware-based systems which perform the specified functions or acts, or combinations of special purpose hardware and computer instructions.

Having described embodiments of the present application, the foregoing description is intended to be exemplary, not exhaustive, and not limited to the disclosed embodiments. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the described embodiments. The terminology used herein is chosen in order to best explain the principles of the embodiments, the practical application, or improvements made to the technology in the marketplace, or to enable others of ordinary skill in the art to understand the embodiments disclosed herein.

Claims

1. A system for determining a diagnostic mode based on a blood vessel engorgement status, comprising:

the host is connected with the pressure measuring device and used for receiving the first pressure signal and the second pressure signal, processing the first pressure signal to obtain a first pressure Pa, and processing the second pressure signal to obtain a second pressure Pd; determining a vascular hyperemia status from the first pressure Pa and/or the second pressure Pd; wherein a third mean pressure proximal of the vascular stenosis is calculated from the first pressure Pa

According to the fourth average voltage

Is equalized with the third stage

Determining the blood vessel congestion state according to the change of the ratio; or inputting the first pressure Pa and/or the second pressure Pd as input data into a sample model for prediction to obtain a prediction result, wherein the sample model is obtained by training a plurality of groups of historical pressure data in a non-hyperemic state and a hyperemic state through a deep learning algorithm; determining the blood vessel congestion state according to the prediction result; if the blood vessel is in a hyperemic state, calculating a first average pressure Pa 'at the proximal end of the vascular stenosis according to the first pressure Pa in the hyperemic state, calculating a second average pressure Pd' at the distal end of the vascular stenosis according to the second pressure Pd in the hyperemic state, and calculating a flow reserve fraction according to the first average pressure Pa 'and the second average pressure Pd'; if the blood vessel is in a non-hyperemic state, a non-hyperemic pressure ratio is calculated based on the first pressure Pa and the second pressure Pd in the non-hyperemic state.

2. The system of claim 1, wherein the host comprises a lower computer and an upper computer, the lower computer being connected to the upper computer, wherein:

3. The system of claim 2, wherein the host computer is further configured to display the fractional flow reserve when the blood vessel is in a hyperemic state; displaying the non-hyperemic pressure ratio when the blood vessel is in a non-hyperemic state.

4. The system of claim 3, wherein the host computer displays the fractional flow reserve when the blood vessel is in a hyperemic state in a manner comprising:

5. The system of claim 3, wherein displaying the decongested pressure ratio when the blood vessel is in a decongested state comprises:

when the non-congestion pressure ratio is within a preset critical interval, obtaining a blood flow reserve fraction in a congestion state; displaying the non-hyperemic pressure ratio and the fractional flow reserve in a hyperemic state simultaneously.

6. The system of claim 2, wherein:

the upper computer comprises a display module, and the display module is used for respectively displaying the non-hyperemic pressure ratio or the fractional flow reserve, or simultaneously displaying the non-hyperemic pressure ratio and the fractional flow reserve.

7. The system of claim 2, wherein:

the lower computer comprises an analog-to-digital conversion module, a pressure conversion module and a first communication module; the analog-to-digital conversion module is used for converting the first pressure signal and the second pressure signal from analog signals to digital electric signals; the pressure conversion module is used for converting the digital electric signal converted by the analog-to-digital conversion module into a corresponding pressure value to obtain the first pressure Pa and the second pressure Pd; the first communication module sends the first pressure Pa and the second pressure Pd to the upper computer.

8. The system of claim 7, wherein:

the upper computer comprises a second communication module, a storage module and a processing module; wherein the second communication module is connected to the first communication module and configured to receive the first pressure Pa and the second pressure Pd, the storage module is configured to store the first pressure Pa and the second pressure Pd, and the processing module is configured to determine a blood vessel hyperemia status according to the first pressure Pa and/or the second pressure Pd, and calculate a blood flow reserve fraction in a hyperemia status and a non-hyperemia pressure ratio in a non-hyperemia status.

9. The system of claim 2, wherein the first mean pressure Pa 'proximal to the vascular stenosis is calculated from the first pressure Pa at hyperemia, and the second mean pressure Pd' distal to the vascular stenosis is calculated from the second pressure Pd at hyperemia:

the upper computer determines a cardiac cycle in the hyperemia state according to the fluctuation rule of the first pressure Pa and/or the fluctuation rule of the second pressure Pd in the hyperemia state; calculating the first mean pressure Pa' proximal to the vascular stenosis from the first pressure Pa of at least one of the cardiac cycles in a hyperemic state; calculating said second mean pressure Pd' distal to said stenosis from said second pressure Pd of said at least one cardiac cycle in a hyperemic state.

10. The system of claim 1, wherein:

the pressure measuring device comprises a first pressure sensor and a second pressure sensor, and the first pressure sensor and the second pressure sensor are both connected with the host; wherein:

the first pressure sensor is used for acquiring the first pressure signal of the blood vessel stenosis proximal end and sending the first pressure signal to the host; the second pressure sensor is used for acquiring the second pressure signal at the far end of the vascular stenosis and sending the second pressure signal to the host.