WO2022142518A1

WO2022142518A1 - Vascular hyperemia state-based diagnostic mode determining method and system

Info

Publication number: WO2022142518A1
Application number: PCT/CN2021/120190
Authority: WO
Inventors: 邵小虎; 林佳燕
Original assignee: 深圳北芯生命科技股份有限公司
Priority date: 2020-12-28
Filing date: 2021-09-24
Publication date: 2022-07-07
Also published as: CN113940651A; CN113940651B; CN113951842B; CN112617771A; CN112617771B; CN113951842A

Abstract

The present application relates to a vascular hyperemia state-based diagnostic mode determining method and system. The method comprises: obtaining a first pressure Pa of a vascular stenosis proximal end and a second pressure Pd of a vascular stenosis distal end; determining a vascular hyperemia state according to the first pressure Pa and/or the second pressure Pd; if a blood vessel is in the hyperemia state, calculating a first mean pressure Pa' of the vascular stenosis proximal end according to the first pressure Pa in the hyperemia state, calculating a second mean pressure Pd' of the vascular stenosis distal end according to the second pressure Pd in the hyperemia state, and calculating a fractional flow reserve according to the first mean pressure Pa' and the second mean pressure Pd'; and if the blood vessel is in a non-hyperemia state, calculating a non-hyperemic pressure ratio according to the first pressure Pa and the second pressure Pd in the non-hyperemia state. According to the solution provided by embodiments of the present application, manually switching a diagnostic mode is not required, an operation duration is saved and the manpower is reduced.

Description

Method and system for determination of diagnostic mode based on vascular congestion state

This application claims the priority of the Chinese patent application filed with the State Intellectual Property Office on December 28, 2020, the application number is 202011581408.4, and the application name is "Method and System for Determining Diagnostic Mode Based on Vascular Congestion State", the entire contents of which are by reference Incorporated in this application.

technical field

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

Background technique

Fractional Flow Reserve (FFR) refers to the ratio of the mean intra-coronary pressure at the distal end of the stenosis to the mean pressure at the proximal end of the coronary artery under the condition of maximum myocardial hyperemia. The gold standard of blood. In the process of FFR measurement, it is necessary to inject drugs to make the blood vessels reach the maximum hyperemia state, but some patients are intolerant to drugs, which leads to the limitation of FFR measurement. Based on this defect, related researchers proposed a new index for measuring intravascular pressure without drug congestion, that is, in a non-congested state, the Non-Hyperemic Pressure Ratio (NHPR).

At present, in clinical applications, the FFR index is used as the diagnostic basis in the hyperemia mode, and the NHPR index is used as the diagnosis basis in the non-congestion mode.

SUMMARY OF THE INVENTION

In order to overcome the problems existing in the related art, the present application provides a method and system for determining a diagnostic mode based on a vascular congestion state, which can manually switch the diagnostic mode without manual operation, which is beneficial to saving operation time and reducing manpower.

A first aspect of the present application provides a method for determining a diagnostic mode based on a vascular congestion state, including:

Obtain the first pressure Pa at the proximal end of the vessel stenosis and the second pressure Pd at the distal end of the vessel stenosis;

determining a vascular congestion state according to the first pressure Pa and/or the second pressure Pd;

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

If the blood vessel is in a non-congested state, the non-congested pressure ratio is calculated according to the first pressure Pa and the second pressure Pd in the non-congested state.

A second aspect of the present application provides a system for determining a diagnostic mode based on a vascular congestion state, including:

a pressure measurement device, used for collecting the first pressure signal at the proximal end of the vascular stenosis, and collecting the second pressure signal at the distal end of the vascular stenosis;

A host computer, connected to the pressure measuring device, for receiving the first pressure signal and the second pressure signal, processing the first pressure signal to obtain a first pressure Pa, and measuring the second pressure signal Perform processing to obtain a second pressure Pd; according to the first pressure Pa and/or the second pressure Pd, determine the blood vessel congestion state; if the blood vessel is in a hyperemia state, calculate the blood vessel according to the first pressure Pa in the hyperemia state The first average pressure Pa' at the proximal end of the vascular stenosis, and the second average pressure Pd' at the distal end of the vascular stenosis is calculated according to the second pressure Pd in the hyperemia state, and according to the first average pressure Pa' and The second average pressure Pd' is used to calculate the blood flow reserve fraction; if the blood vessel is in a non-congested state, the non-congested pressure ratio is calculated according to the first pressure Pa and the second pressure Pd in the non-congested state.

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

Description of drawings

The above and other objects, features and advantages of the present application will become more apparent from the more detailed description of the exemplary embodiments of the present application in conjunction with the accompanying drawings, wherein the same reference numerals generally represent the exemplary embodiments of the present application. same parts.

1 is a schematic flowchart of a method for determining a diagnostic mode based on a vascular congestion state according to an embodiment of the present application;

2 is a pressure data waveform diagram shown in an embodiment of the present application;

Fig. 3 is a kind of non-congestion state and the pressure data waveform diagram under the hyperemia state shown in the embodiment of the present application;

4 is a schematic structural diagram of a device for determining a diagnostic mode based on a vascular congestion state according to an embodiment of the present application;

5 is a schematic structural diagram of an electronic device shown in an embodiment of the present application;

FIG. 6 is a schematic structural diagram of a system for determining a diagnostic mode based on a vascular congestion state according to an embodiment of the present application.

Embodiments of the present invention

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

The terminology used in this application is for the purpose of describing particular embodiments only and is not intended to limit the application. As used in this application and the appended claims, the singular forms "a," "the," and "the" are intended to include the plural forms as well, unless the context clearly dictates otherwise. It will also be understood that the term "and/or" as used herein refers to and includes 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 in this application to describe various information, such information should not be limited by these terms. These terms are only used to distinguish the same type of information from each other. For example, the first information may also be referred to as the second information, and similarly, the second information may also be referred to as the first information without departing from the scope of the present application. Thus, a feature defined as "first" or "second" may expressly or implicitly include one or more of that feature. In the description of the present application, "plurality" means two or more, unless otherwise expressly and specifically defined.

The embodiments of the present application provide a method for determining a diagnostic mode based on a vascular congestion state. As shown in Figure 1, the method may include the following steps:

S110: Obtain the first pressure Pa at the proximal end of the vascular stenosis and the second pressure Pd at the distal end of the vascular stenosis.

In the embodiment of the present application, an interventional catheter technique can be used to measure the pressure in the blood vessel to determine the disease condition of the patient's blood vessel, such as stenosis. In one embodiment, a pressure measurement device, such as a MEMS (Micro-Electro-Mechanical System, micro-electromechanical system) pressure sensor, an optical fiber pressure sensor, etc., can be integrated on the interventional catheter. The pressure measurement device may include a first pressure sensor and a second pressure sensor, wherein the first pressure sensor may be arranged outside the human body, and by being connected with the guiding catheter (hollow) inserted into the human body, the blood drawn from the guiding catheter can be sensed pressure. The head end of the guiding catheter is located at the proximal end of the vascular stenosis lesion, and the tail end is arranged outside the body and is connected with the first pressure sensor, so that the first pressure sensor can measure the pressure data of the proximal end of the vascular stenosis lesion. The second pressure sensor can be installed in the human body, and can be integrated at the head end of the pressure micro-catheter. The pressure micro-catheter passes through the guide catheter and penetrates deep into the distal end of the vascular stenosis, so that the second pressure sensor can measure the distal end of the vascular stenosis. pressure data. It can be understood that, before the first pressure sensor and the second pressure sensor measure the blood vessel pressure, the first pressure sensor and the second pressure sensor may be respectively subjected to a zero calibration process. Afterwards, pressure equalization can be performed on the two pressure sensors. In one embodiment, when the second pressure sensor reaches the head end of the guiding catheter, the second pressure sensor is adjusted based on the pressure of the first pressure sensor, so that the two pressure sensors are adjusted. The pressure sensor maintains a unified pressure reference, so that the measurement error between the two pressure sensors can be eliminated, thereby improving the accuracy of the measurement results.

In the embodiment of the present application, the blood vessel may be a coronary artery, the proximal end of the vascular stenosis lesion may be the coronary ostium, and the distal end of the vascular stenosis lesion may be the distal end of the coronary stenosis lesion and away from the coronary ostium. Of course, the possibility that it can be applied to other blood vessels, such as peripheral blood vessels, is not excluded.

In step S110, the first pressure sensor may be used to collect the pressure data of the proximal end of the vascular stenosis in real time, and the second pressure sensor may be used to collect the pressure data of the distal end of the vascular stenosis in real time, respectively through analog-to-digital conversion (analog data collected by the pressure sensor). The signal is converted into a digital electrical signal), the pressure calculation (the digital electrical signal is converted into a pressure value), and finally converted into a first pressure Pa and a second pressure Pd.

In step S110, the first pressure Pa and the second pressure Pd may also be obtained directly from a local storage device or a network terminal. In one embodiment, the first pressure Pa obtained by converting the pressure data collected by the first pressure sensor can be stored in a data link list, where the data link list uses time as an index, and takes time and real-time pressure values as key-value pairs. save. Similarly, the second pressure Pd obtained by converting the pressure data collected by the second pressure sensor may be stored in the above method. The data link list can be stored in local storage or on the network. Taking the time as the index value, the corresponding pressure value is obtained from the data link table to obtain the first pressure Pa and the second pressure Pd.

S120. Determine 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 can generate a pressure waveform curve, and the second pressure Pd at the same time can also generate a pressure waveform curve. Among them, Figure 2 contains two sets of waveform diagrams, the previous group of waveform diagrams is the waveform curve of the first pressure Pa, the waveform curve of the second pressure Pd, and the average value of the first pressure Pa at different times. third mean pressure

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

Among them, the abscissa represents time, in seconds; the ordinate represents pressure, in millimeters of mercury. The upper waveform in the next set of waveforms represents the real-time pressure difference between the first pressure Pa and the second pressure Pd, and the lower waveform represents the fourth average pressure

with the third mean pressure

ratio. Assuming that Figure 2 is the corresponding waveform in the maximum hyperemia state, the fourth average pressure

with the third mean pressure

The ratio is the FFR value.

It can be seen from FIG. 2 that the waveforms of the first pressure Pa and the second pressure Pd are basically the same. Therefore, it can be determined whether the blood vessel is not based on the waveform of the first pressure Pa and/or the waveform of the second pressure Pd. in a state of maximum hyperemia.

In an optional embodiment, a 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:

Calculate the third mean pressure at the proximal end of the vessel stenosis based on the first pressure Pa

Calculate the fourth mean pressure at the distal end of the vessel stenosis based on the second pressure Pd

According to the fourth mean pressure

with the third mean pressure

Changes in the ratio to determine the state of vascular congestion.

In an embodiment, the first pressure Pa measured in real time by the first pressure sensor can be used to sum and average to obtain the third average pressure

And the second pressure Pd measured in real time by the second pressure sensor is summed and averaged to obtain the fourth average pressure

Then according to the fourth average pressure

with the third mean pressure

The change of the ratio to identify whether the blood vessels are congested or not. For example, as shown in Figure 3, the fourth average pressure

with the third mean pressure

After a period of time stability (stage ①: stable period without hyperemia) and then an overall decrease (stage ②: fluctuating period under hyperemia), the ratio begins to decrease and it can be considered that the injection of drugs (such as adenosine) is started to make the blood vessels reach the Maximum hyperemia. After a period of time, the hyperemia state enters a stable period (stage ③: the stable period in the hyperemia state), and when the drug injection is stopped, the mean pressure ratio begins to rise again (stage ④: the transition from the hyperemia state to the non-congestive state). When the mean pressure ratio remains unchanged, it can be considered that the blood vessels are in a non-congested state; when the mean pressure ratio shows the above change pattern, it can be considered that the blood vessels are in a congested state after the mean pressure ratio decreases and stabilizes.

Taking the first pressure Pa and/or the second pressure Pd as input data, and inputting a sample model for prediction to obtain a prediction result, wherein the sample model can be used for multiple sets of historical pressure data in a non-congested state and a hyperemic state through deep learning algorithm training;

Based on the predicted results, the vascular congestion state is determined.

In one embodiment, based on machine learning, multiple sets of historical pressure data can be manually calibrated and divided into two states: hyperemia and non-congestion, and then trained and fitted by a multi-layer neural network to acquire The characteristic difference between congested and uncongested waveforms is used to obtain a sample model. By using the waveforms of the first pressure Pa and/or the second pressure Pd as input data into the sample model obtained by training for prediction and comparison, the judgment of the congestion and non-congestion states is completed, and the recognition of the blood vessel congestion state is realized.

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

S130. If the blood vessel is in a hyperemia state, calculate the first average pressure Pa' at the proximal end of the blood vessel stenosis according to the first pressure Pa in the hyperemia state, and calculate the second average pressure at the distal end of the blood vessel stenosis according to the second pressure Pd in the hyperemia state Pd', and calculate the blood flow reserve fraction according to the first mean pressure Pa' and the second mean pressure Pd'.

As shown in FIG. 3 , since the first pressure Pa and the second pressure Pd in the hyperemia state both change relative to before hyperemia, the pressure values tend to decrease after hyperemia compared to before hyperemia. The first average pressure Pa' at the proximal end of the vascular stenosis can be obtained by summing the first pressure Pa' within a period of time (such as stage ③) after the congestive state is stable, and taking the second pressure Pd within the same time period to obtain the mean value. and take the average to obtain the second mean pressure Pd' at the distal end of the vessel stenosis. By calculating the ratio of the second mean pressure Pd' to the first mean pressure Pa', the fractional flow reserve FFR value is obtained.

In an optional embodiment, step S130 calculates the first average pressure Pa' at the proximal end of the vascular stenosis according to the first pressure Pa in the hyperemia state, and calculates the first average pressure Pa' at the distal end of the vascular stenosis according to the second pressure Pd under the hyperemia state. Specific embodiments of the two average pressures Pd' may include:

According to the fluctuation law of the first pressure Pa and/or the fluctuation law of the second pressure Pd under the hyperemia state, determine the cardiac cycle under the hyperemia state;

Calculate the first average pressure Pa' of the proximal end of the vascular stenosis according to the first pressure Pa of at least one cardiac cycle in the hyperemia state;

The second average pressure Pd' at the distal end of the vascular stenosis is calculated according to the second pressure Pd of the at least one cardiac cycle in the hyperemia state.

In one embodiment, in order to make the value of the mean pressure more accurate, the mean pressure may be calculated by using the pressure value of at least one cardiac cycle. Because not only the pressure value will change before and after vascular congestion, but also the cardiac cycle may change. For example, the cardiac cycle after hyperemia is smaller than the cardiac cycle before hyperemia. In order to make the calculated FFR value more accurate, the cardiac cycle in the hyperemia state can 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, and then take The first pressure Pa in at least one cardiac cycle is summed and averaged to obtain the first average pressure Pa', and the second pressure Pd in the same cardiac cycle is summed and averaged to obtain the second average pressure Pd', and the The ratio of the second average pressure Pd' to the first average pressure Pa' is used as the FFR value, that is, FFR=Pd'/Pa'.

S140. If the blood vessel is in a non-congestive state, calculate a non-congestive pressure ratio according to the first pressure Pa and the second pressure Pd in the non-congestive state.

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

According to the fluctuation law of the first pressure Pa and/or the fluctuation law of the second pressure Pd in the non-congestive state, determine the cardiac cycle in the non-congestive state;

Calculate the ratio of the second pressure Pd in the diastolic phase to the first pressure Pa in at least one cardiac cycle under an anemia state, to obtain an anemia pressure ratio.

As shown in FIG. 2 , since the fluctuation law of the first pressure Pa is very similar to the fluctuation law of the second pressure Pd, one of the pressure waveforms can be selected to determine the cardiac cycle, or two waveforms can be selected together to determine the cardiac cycle. The cardiac cycle consists of systole and diastole, with pressure increasing during systole and decreasing during diastole. The first pressure Pa and the second pressure Pd in a period of time during the diastolic period of at least one cardiac cycle in a non-congestive state can be taken. In one embodiment, the time from 25% of the beginning of the diastolic period to 5 ms before the end of the diastolic period can be taken. The no-congestion pressure ratio NHPR value can be obtained by calculating the ratio of the second pressure Pd to the first pressure Pa in the no-wave period and taking the average value.

In addition, the stationary period in each cardiac cycle may also be calculated, wherein the stationary period may be a period of time during which the ratio of the second pressure Pd and the first pressure Pa is derived in time, and the derivative is stable and tends to 0. Generally, the stationary phase is also in the diastolic phase of the cardiac cycle. The NHPR value can be obtained by taking the ratio of the second pressure Pd to the first pressure Pa in the stationary phase in at least one cardiac cycle, and then taking the average value.

In an optional embodiment, the method shown in FIG. 1 may further comprise the following steps:

When the blood vessels are in a state of congestion, the fractional flow reserve is displayed;

When the blood vessel is in a non-congested state, the non-congestive pressure ratio is displayed.

In one embodiment, when the blood vessel is in a congested state, the FFR diagnostic mode can be entered, and after the FFR value is calculated, the FFR value can be output and displayed, so that relevant personnel (such as researchers, doctors, etc.) can use the FFR value as the The diagnosis is based on the determination of the myocardial ischemia of the patient, and then the treatment plan is determined. For example, if the FFR value is less than 0.75, manual intervention can be performed for revascularization, such as stent placement; if the FFR value is greater than 0.8, conservative drug therapy can be performed.

When the blood vessel is in a non-congested state, the NHPR diagnostic mode can be entered. After the NHPR value is calculated, the NHPR value can be output and displayed, so that the relevant personnel can use the NHPR value as a diagnostic basis to determine the patient's myocardial ischemia. Determine a treatment plan. For example, if the NHPR value is less than 0.9, manual intervention treatment can be performed; if the NHPR value is greater than 0.9, drug conservative treatment can be performed.

In an optional embodiment, when the blood vessel is in a congested state, the specific embodiment of displaying the fractional blood flow reserve may further include the following steps:

When the blood flow reserve fraction is within the preset grayscale interval, obtain the non-congestive pressure ratio before the hyperemia state;

Fractional flow reserve and pre-congestive-free pressure ratio are also displayed.

Among them, the grayscale interval of the FFR value is generally set to be between 0.75 and 0.8. When the FFR value is within the preset grayscale interval, the diagnosis scheme can be determined in combination with the NHPR value. The NHPR value before hyperemia can be obtained and displayed in dual mode, that is, the FFR value and the NHPR value can be displayed at the same time, so that the NHPR value can be used as auxiliary diagnostic information, which can better allow relevant personnel to draw treatment plans. 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 performed; if the FFR value is between 0.75 and 0.8 and the NHPR value is greater than 0.9, conservative drug treatment can be performed. It can be understood that, the NHPR value calculated within a period of time after the congestion is over (for example, after stopping the injection of adenosine) can also be obtained as auxiliary diagnostic information, which is not limited here.

In an optional embodiment, when the blood vessel is in a non-congested state, the specific embodiment of displaying the non-congestive pressure ratio may further include the following steps:

When the non-congestive pressure ratio is within the preset critical interval, obtain the blood flow reserve fraction in the hyperemic state;

At the same time, the noncongestive pressure ratio and the fractional flow reserve in the hyperemic state are displayed.

In one embodiment, when the NHPR value calculated in the non-congestive mode is in the critical region, the diagnostic information can be comprehensively output in combination with the FFR value in the hyperemic state. For example, assuming that the critical interval 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, manual intervention can be performed; when the NHPR value is between 0.86-0.93 and the FFR value is greater than 0.8, Conservative drug treatment is possible.

To sum up, the embodiments of the present application identify the vascular congestion state by analyzing the fluctuation of the first pressure Pa at the proximal end of the vascular stenosis and/or the fluctuation of the second pressure Pd at the distal end of the vascular stenosis; Calculate the ratio of the first average pressure Pa' at the proximal end of the vascular stenosis to the second average pressure Pd' at the distal end of the vascular stenosis in the hyperemic state, and obtain the fractional flow reserve FFR value; The non-congestion pressure ratio NHPR value is obtained by calculating the first pressure Pa and the second pressure Pd in the state. Compared with the existing manual manual switching of the diagnosis mode, the present application can intelligently identify the vascular congestion state by analyzing the vascular pressure data, and automatically switch to the corresponding mode to calculate the diagnostic parameters according to the identification result, without manual manual operation. , which can help save operation time and reduce manpower. In addition, the present application also supports dual-mode display. For the critical area of FFR diagnosis and the critical area of NHPR diagnosis, auxiliary diagnosis information can be comprehensively output, which can better guide doctors to determine the treatment plan.

The embodiments of the present application further provide a device for determining a diagnostic mode based on a vascular congestion state, which can be used to execute the method for determining a diagnostic mode based on a vascular congestion state provided in the foregoing embodiments. As shown in Figure 4, the apparatus may include:

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

a state determination module 42, configured to determine the vascular congestion state according to the first pressure Pa and/or the second pressure Pd;

The first calculation module 43 is configured to calculate the first average pressure Pa' at the proximal end of the vascular stenosis according to the first pressure Pa in the hyperemia state when the state determination module 42 determines that the blood vessel is in a hyperemia state, and calculate the first average pressure Pa' at the proximal end of the vascular stenosis according to the first pressure Pa in the hyperemia state, The pressure Pd calculates the second mean pressure Pd' at the distal end of the vascular stenosis, and calculates the blood flow reserve fraction according to the first mean pressure Pa' and the second mean pressure Pd';

The second calculation unit 44 is configured to calculate the non-congestive pressure ratio according to the first pressure Pa and the second pressure Pd in the non-congested state when the state determination module 42 determines that the blood vessel is in the non-congested state.

Optionally, the first calculation module 43 calculates the first average pressure Pa′ at the proximal end of the vascular stenosis according to the first pressure Pa in the hyperemia state, and calculates the second average pressure at the distal end of the vascular stenosis according to the second pressure Pd under the hyperemia state. The way of pressing Pd' can include:

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

Optionally, the second calculation unit 44 may be specifically configured to determine the cardiac cycle in the non-congestive state according to the fluctuation law of the first pressure Pa and/or the fluctuation law of the second pressure Pd in the non-congestive state, and calculate the non-congestive state. The ratio of the second pressure Pd in the diastolic phase to the first pressure Pa in the next at least one cardiac cycle is obtained 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), in one embodiment:

The first display module is used to display the blood flow reserve fraction when the blood vessel is in a congested state;

The second display module is used for displaying the no-congestion pressure ratio when the blood vessel is in the no-congestion state.

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

The first display module acquires the non-congestion pressure ratio before the hyperemia state when the blood flow reserve fraction is within the preset grayscale interval; and simultaneously displays the blood flow reserve fraction and the non-congestion pressure ratio before the hyperemia state.

Optionally, when the blood vessel is in a non-congestive state, the second display module may display the non-congestive pressure ratio in a manner including:

The second display module obtains the blood flow reserve fraction under the hyperemia state when the non-congestive pressure ratio is within the preset critical interval; and simultaneously displays the non-congestive pressure ratio and the blood flow reserve fraction under the hyperemia state.

Optionally, the state determination module 42 may be specifically configured to calculate the third average pressure at the proximal end of the vascular stenosis according to the first pressure Pa.

According to the fourth mean pressure

with the third mean pressure

Changes in the ratio to determine the state of vascular congestion.

Optionally, the state determination module 42 may be specifically configured to use the first pressure Pa and/or the second pressure Pd as input data, input the sample model for prediction, obtain the prediction result, and determine the vascular congestion state according to the prediction result; The sample model is trained by deep learning algorithm using multiple sets of historical pressure data in non-congested and hyperemic states.

Regarding the apparatus in the above-mentioned embodiment, the specific manner in which each module performs the operation has been described in detail in the embodiment of the method, and will not be described in detail here.

Implementing the device shown in Figure 4 can intelligently identify the vascular congestion state by analyzing the vascular pressure data, and automatically switch to the corresponding mode to calculate the diagnostic parameters according to the identification result, without manual manual operation. When applied in clinical practice, it can help save surgery. time and reduce manpower. In addition, the device also supports dual-mode display, and can comprehensively output auxiliary diagnosis information for the critical area of FFR diagnosis and the critical area of NHPR diagnosis, which can better guide doctors to determine the treatment plan.

Embodiments of the present application further provide an electronic device, which can be used to execute the method for determining a diagnostic mode based on a vascular congestion state provided by the foregoing embodiments. In one embodiment, 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 other components. Among other things, these components may be communicatively connected through one or more communication buses 504 . Those skilled in the art can understand that the structure of the electronic device 500 shown in FIG. 5 does not constitute a limitation on the embodiments of the present application, and it may be a bus-shaped structure or a star-shaped structure, and may also include more More or fewer components, or a combination of certain components, or a different arrangement of components. in:

The processor 501 may be a central processing unit (Central Processing Unit, CPU), or other general-purpose processors, digital signal processors (Digital Signal Processors, DSPs), application specific integrated circuits (Application Specific Integrated Circuits, ASICs), field-available processors. Field-Programmable Gate Array (FPGA) or other programmable logic devices, discrete gate or transistor logic devices, discrete hardware components, etc. A general purpose processor may be a microprocessor or the processor may be any conventional processor or the like.

Memory 502 may include various types of storage units, such as system memory, read only memory (ROM), and persistent storage. The ROM may store static data or instructions required by the processor 501 or other modules of the computer. Persistent storage devices may be readable and writable storage devices. Permanent storage may be a non-volatile storage device that does not lose stored instructions and data even if the computer is powered off. In some embodiments, persistent storage devices employ mass storage devices (eg, magnetic or optical disks, flash memory) as persistent storage devices. In other embodiments, persistent storage may be a removable storage device (eg, a floppy disk, an optical drive). System memory can be a readable and writable storage device or a volatile readable and writable storage device, such as dynamic random access memory. System memory can store some or all of the instructions and data that the processor needs at runtime. Additionally, memory 502 may comprise 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 may also be employed. In some implementations, the memory 502 may include a removable storage device that is readable and/or writable, such as a compact disc (CD), a read-only digital versatile disc (eg, DVD-ROM, dual-layer DVD-ROM), Read-only Blu-ray Discs, Ultra-Density Discs, Flash Cards (eg SD Cards, Min SD Cards, Micro-SD Cards, etc.), Magnetic Floppy Disks, etc. Computer readable storage media do not contain carrier waves and transient electronic signals transmitted over wireless or wire.

The communication interface 503 may include a wired communication interface, a wireless communication interface, etc., and may be used to communicate and interact with pressure sensors or other devices.

The memory 502 stores executable codes, and when the executable codes are processed by the processor 501, the processor 501 can be made to execute some or all of the steps in the above-mentioned method for determining a diagnostic mode based on a blood vessel congestion state.

The embodiments of the present application further provide a system for determining a diagnostic mode based on a vascular congestion state, which can be used to execute the method for determining a diagnostic mode based on a vascular congestion state provided in the foregoing embodiments. As shown in FIG. 6, the system may at least include: a pressure measuring device 10 and a host 20, wherein:

The pressure measurement device 10 is used for collecting the first pressure signal at the proximal end of the vascular stenosis, and collecting the second pressure signal at the distal end of the vascular stenosis;

The host 20, connected with the pressure measuring device 10, is used for receiving the first pressure signal and the second pressure signal, processing the first pressure signal to obtain the first pressure Pa, and processing the second pressure signal to obtain the second pressure Pd; According to the first pressure Pa and/or the second pressure Pd, the blood vessel congestion state is determined; if the blood vessel is in the hyperemia state, the first average pressure Pa' at the proximal end of the blood vessel stenosis is calculated according to the first pressure Pa in the hyperemia state, and Calculate the second average pressure Pd' at the distal end of the vascular stenosis, and calculate the blood flow reserve fraction according to the first average pressure Pa' and the second average pressure Pd'; if the blood vessel is in a non-congested state, according to the The no-congestion pressure ratio is calculated from the first pressure Pa and the second pressure Pd in the state.

Optionally, the host computer 20 may include a lower computer 21 and an upper computer 22, and the lower computer 21 is connected with 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 the first pressure Pa, and processing the second pressure signal to obtain the second pressure Pd, and combining the first pressure Pa and the second pressure signal. The second pressure Pd is sent to the upper computer 22;

The upper computer 22 is used to determine the blood vessel congestion state according to the first pressure Pa and/or the second pressure Pd; if the blood vessel is in the blood vessel state, calculate the first average pressure Pa' of the proximal end of the blood vessel stenosis according to the first pressure Pa under the blood vessel state , and calculate the second average pressure Pd' at the distal end of the vascular stenosis according to the second pressure Pd in the hyperemia state, and calculate the blood flow reserve fraction according to the first average pressure Pa' and the second average pressure Pd'; state, the non-congestive pressure ratio is calculated according to the first pressure Pa and the second pressure Pd in the non-congested state.

Optionally, the manner in which the host computer 22 determines the blood vessel congestion state according to the first pressure Pa and/or the second pressure Pd may include:

The upper computer 22 calculates the third average pressure at the proximal end of the vascular stenosis according to the first pressure Pa

According to the fourth mean pressure

with the third mean pressure

Changes in the ratio to determine the state of vascular congestion.

The host computer 22 takes the first pressure Pa and/or the second pressure Pd as input data, inputs the sample model for prediction, obtains the prediction result, and determines the vascular congestion state according to the prediction result; wherein, the sample model uses the non-congestive state and the hyperemia state. The multiple sets of historical pressure data in the state are obtained through deep learning algorithm training.

Optionally, the host computer 22 calculates the first average pressure Pa' at the proximal end of the vascular stenosis according to the first pressure Pa in the hyperemia state, and calculates the second average pressure Pd at the distal end of the vascular stenosis according to the second pressure Pd under the hyperemia state. ' way can include:

The host computer 22 determines the cardiac cycle under the hyperemia state according to the fluctuation law of the first pressure Pa and/or the second pressure Pd under the hyperemia state; calculates the blood vessel according to the first pressure Pa of at least one cardiac cycle under the hyperemia state. The first mean pressure Pa' at the proximal end of the stenosis; the second mean pressure Pd' at the distal end of the vessel stenosis is calculated according to the second pressure Pd at the at least one cardiac cycle in the hyperemia state.

Optionally, the manner in which the host computer 22 calculates the non-congestive pressure ratio according to the first pressure Pa and the second pressure Pd in the non-congested state may include:

The host computer 22 determines the cardiac cycle in the non-congested state according to the fluctuation law of the first pressure Pa and/or the fluctuation law of the second pressure Pd in the non-congested state; The ratio of the second pressure Pd to the first pressure Pa to obtain the no-congestion pressure ratio.

In one embodiment, 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 to convert the first pressure signal and the second pressure signal from analog signals into digital electrical signals. The pressure conversion module is used to convert the digital electrical signal converted by the analog-to-digital conversion module into a corresponding pressure value, thereby obtaining the first pressure Pa and the second pressure Pd. The first pressure Pa and the second pressure Pd are then sent to the upper computer 22 through the first communication module.

The upper computer 22 may include a second communication module, a storage module and a processing module. Wherein, the second communication module is connected with the first communication module, and is used for receiving the first pressure Pa and the second pressure Pd. The storage module is used to store the first pressure Pa, the second pressure Pd, and other data. The processing module is used to determine the vascular congestion state according to the first pressure Pa and/or the second pressure Pd, calculate the blood flow reserve fraction in the hyperemia state, and calculate the non-congestion pressure ratio in the non-congestive state.

Optionally, the host computer 22 can also be used to display the blood flow reserve fraction when the blood vessel is in a congested state; and display the non-congestive pressure ratio when the blood vessel is in a non-congested state.

Optionally, when the blood vessel is in a congested state, the upper computer 22 may display the blood flow reserve fraction in the following manner:

When the blood flow reserve fraction is within the preset grayscale interval, the host computer 22 obtains the non-congestive pressure ratio before the hyperemia state, and simultaneously displays the blood flow reserve fraction and the non-congestive pressure ratio before the hyperemia state.

Optionally, when the blood vessel is in a non-congestive state, the upper computer 22 displays the non-congestive pressure ratio in a manner including:

The host computer 22 obtains the blood flow reserve fraction in the hyperemia state when the non-congestion pressure ratio is within the preset critical interval, and simultaneously displays the non-congestion pressure ratio and the blood flow reserve fraction in the hyperemia state.

In one embodiment, the host computer 22 may further include a display module, which may be used to display different diagnostic parameters in different modes, and may also support dual-mode display, that is, simultaneously display the FFR value and the NHPR value. In addition, the display module can also be used to display real-time waveforms of the first pressure Pa, the second pressure Pd, and Pd/Pa.

Optionally, the pressure measurement 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 to collect the first pressure signal of the proximal end of the vascular stenosis and send it to the host 20;

The second pressure sensor 12 is used to collect the second pressure signal at the distal end of the stenosis of the blood vessel, and send it to the host 20 .

Implementing the system shown in FIG. 6 can intelligently identify the state of vascular congestion, display different diagnostic parameters in different states, and no manual operation is required. When applied in clinical practice, it can save operation time and reduce manpower. In addition, the system can also support dual-mode operation of FFR and NHPR. FFR and NHPR can be used as complementary diagnostic results. When the FFR is in the critical range, the NHPR value can be referred to, which can guide intraoperative operations more accurately.

Various embodiments of the present application have been described above, and the foregoing descriptions are exemplary, not exhaustive, and not limiting of the disclosed embodiments. Numerous 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 was chosen to best explain the principles of the various embodiments, the practical application or improvement over the technology in the marketplace, or to enable others of ordinary skill in the art to understand the various embodiments disclosed herein.

Claims

A method for determining a diagnostic mode based on a vascular congestion state, comprising:

Obtain the first pressure Pa at the proximal end of the vessel stenosis and the second pressure Pd at the distal end of the vessel stenosis;

determining a vascular congestion state according to the first pressure Pa and/or the second pressure Pd;

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

If the blood vessel is in a non-congested state, the non-congested pressure ratio is calculated according to the first pressure Pa and the second pressure Pd in the non-congested state.
The method according to claim 1, wherein the first average pressure Pa' at the proximal end of the vascular stenosis is calculated according to the first pressure Pa in the hyperemia state, and the first average pressure Pa' at the proximal end of the vascular stenosis is calculated according to the hyperemia state Two pressures Pd Calculate the second average pressure Pd' at the distal end of the vascular stenosis, including:

According to the fluctuation law of the first pressure Pa and/or the fluctuation law of the second pressure Pd in the hyperemia state, determine the cardiac cycle in the hyperemia state;

Calculate the first average pressure Pa' at the proximal end of the vascular stenosis according to the first pressure Pa in at least one cardiac cycle in a hyperemia state;

The second mean pressure Pd' at the distal end of the vessel stenosis is calculated from the second pressure Pd of the at least one cardiac cycle in a hyperemic state.
The method according to claim 1, wherein the calculating a non-congestive pressure ratio according to the first pressure Pa and the second pressure Pd in a non-congestive state comprises:

According to the fluctuation law of the first pressure Pa and/or the fluctuation law of the second pressure Pd in the non-congestive state, determine the cardiac cycle in the non-congestive state;

Calculate the ratio of the second pressure Pd in the diastolic phase to the first pressure Pa in at least one cardiac cycle in an anaemic state, to obtain an anaemic pressure ratio.
The method according to claim 3, wherein:

obtaining the first pressure Pa and the second pressure Pd of the wave-free period from 25% of the beginning of the diastolic period to 5 ms before the end of the diastolic period;

The ratio of the second pressure Pd to the first pressure Pa in the no-wave period is calculated to obtain the no-congestion pressure ratio.
The method according to claim 1, wherein the calculating a non-congestive pressure ratio according to the first pressure Pa and the second pressure Pd in a non-congestive state comprises:

According to the fluctuation law of the first pressure Pa and/or the fluctuation law of the second pressure Pd in the non-congestive state, determine the cardiac cycle in the non-congestive state;

calculating a plateau in each of said cardiac cycles;

Obtaining the ratio of the second pressure Pd to the first pressure Pa in the stationary phase in at least one of the cardiac cycles, to obtain the no-congestion pressure ratio.
The method according to claim 1, wherein the method further comprises:

When the blood vessel is in a congested state, displaying the blood flow reserve fraction;

When the blood vessel is in a non-congested state, the non-congested pressure ratio is displayed.
The method according to claim 6, wherein the displaying the blood flow reserve fraction when the blood vessel is in a congested state comprises:

When the blood flow reserve fraction is within the preset grayscale interval, obtain the no-congestion pressure ratio before the congested state;

The fractional flow reserve and the pre-congestive state pre-congestive pressure ratio are also displayed.
The method according to claim 6, wherein when the blood vessel is in a non-congested state, displaying the non-congestive pressure ratio comprises:

When the non-congestive pressure ratio is within a preset critical interval, obtain a blood flow reserve fraction in a congested state;

The non-congestive pressure ratio and the fractional flow reserve in the hyperemic state are displayed simultaneously.
The method according to any one of claims 1-8, wherein the determining the vascular congestion state according to the first pressure Pa and/or the second pressure Pd comprises:

Calculate the third average pressure at the proximal end of the vascular stenosis according to the first pressure Pa

Calculate the fourth average pressure at the distal end of the vessel stenosis according to the second pressure Pd

According to the fourth average pressure
with the third mean pressure
Changes in the ratio to determine the state of vascular congestion.
The method according to claim 9, wherein,

When the ratio remains stable, the blood vessel is in a non-congested state and enters the NHPR diagnostic mode; when the ratio decreases or stabilizes after decreasing, the blood vessel is in a congested state and enters the FFR diagnostic mode.
The method according to any one of claims 1-8, wherein the determining the vascular congestion state according to the first pressure Pa and/or the second pressure Pd comprises:

The first pressure Pa and/or the second pressure Pd are used as input data, and a sample model is input for prediction, and a prediction result is obtained, wherein the sample model uses multiple sets of historical pressures in a non-congested state and a hyperemic state The data is obtained by training the deep learning algorithm;

Based on the predicted results, the vascular congestion state is determined.
A diagnostic mode determination system based on vascular congestion state, characterized in that it includes:

a pressure measurement device, used for collecting the first pressure signal at the proximal end of the vascular stenosis, and collecting the second pressure signal at the distal end of the vascular stenosis;

A host computer, connected to the pressure measuring device, for receiving the first pressure signal and the second pressure signal, processing the first pressure signal to obtain a first pressure Pa, and measuring the second pressure signal Perform processing to obtain a second pressure Pd; according to the first pressure Pa and/or the second pressure Pd, determine the blood vessel congestion state; if the blood vessel is in a hyperemia state, calculate the blood vessel according to the first pressure Pa in the hyperemia state The first average pressure Pa' at the proximal end of the vascular stenosis, and the second average pressure Pd' at the distal end of the vascular stenosis is calculated according to the second pressure Pd in the hyperemia state, and according to the first average pressure Pa' and The second average pressure Pd' is used to calculate the blood flow reserve fraction; if the blood vessel is in a non-congested state, the non-congested pressure ratio is calculated according to the first pressure Pa and the second pressure Pd in the non-congested state.
The system according to claim 12, wherein the host comprises a lower computer and an upper computer, the lower computer is connected with the upper computer, wherein:

The lower computer is used to receive the first pressure signal and the second pressure signal, process the first pressure signal to obtain a first pressure Pa, and process the second pressure signal to obtain a second pressure Pd, and send the first pressure Pa and the second pressure Pd to the upper computer;

The upper computer is used to determine the blood vessel congested state according to the first pressure Pa and/or the second pressure Pd; if the blood vessel is in a congested state, calculate the blood vessel stenosis according to the first pressure Pa in the congested state The first mean pressure Pa' at the proximal end, and the second mean pressure Pd' at the distal end of the vascular stenosis is calculated according to the second pressure Pd in the hyperemic state, and the first mean pressure Pa' is related to the The second average pressure Pd' calculates the blood flow reserve fraction; if the blood vessel is in a non-congestive state, the non-congestive pressure ratio is calculated according to the first pressure Pa and the second pressure Pd in the non-congestive state.
The system according to claim 13, wherein the first average pressure Pa' at the proximal end of the vascular stenosis is calculated according to the first pressure Pa in the hyperemia state, and the vascular stenosis is calculated according to the second pressure Pd in the hyperemia state The second mean pressure Pd' at the distal end, including:

The host computer determines the cardiac cycle in the hyperemia state according to the fluctuation law of the first pressure Pa and/or the second pressure Pd in the hyperemia state; calculates the cardiac cycle according to the first pressure Pa of at least one cardiac cycle in the hyperemia state The first average pressure Pa' at the proximal end of the vascular stenosis; the second average pressure Pd' at the distal end of the vascular stenosis is calculated according to the second pressure Pd in the at least one cardiac cycle in the hyperemia state.
The system according to claim 13, wherein the upper computer is further configured to display the blood flow reserve fraction when the blood vessel is in a congested state; and display the non-congestive pressure ratio when the blood vessel is in a non-congested state .
The system according to claim 15, wherein when the blood vessel is in a congested state, the upper computer displays the blood flow reserve fraction in a manner comprising:

When the blood flow reserve fraction is within the preset grayscale interval, the host computer acquires the non-congestion pressure ratio before the hyperemia state, and simultaneously displays the blood flow reserve fraction and the non-congestion pressure ratio before the hyperemia state.
The system according to claim 12, wherein the pressure measurement device comprises a first pressure sensor and a second pressure sensor, and the first pressure sensor and the second pressure sensor are both connected to the host; in:

the first pressure sensor is used to collect the first pressure signal of the proximal end of the vascular stenosis and send it to the host;

The second pressure sensor is used for collecting a second pressure signal at the distal end of the vascular stenosis and sending it to the host.
The system according to claim 13, wherein the lower computer comprises an analog-to-digital conversion module, a pressure conversion module and a first communication module; wherein the analog-to-digital conversion module is used for converting the first pressure signal and the The second pressure signal is converted from an analog signal to a digital electrical signal.
The system according to claim 18, wherein the host 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 is used for receiving the the first pressure Pa and the second pressure Pd; the storage module is used to store the first pressure Pa and the second pressure Pd; the processing module is used to store the first pressure Pa and/or the second pressure Pd; The second pressure Pd determines the vascular congestion state, and calculates the blood flow reserve fraction in the hyperemia state, and calculates the non-congestion pressure ratio in the non-congestive state.
The system according to any one of claims 12 to 19, wherein the host computer includes a display module, and the display module is used to display different diagnostic parameters in different modes, and/or simultaneously display no Congestion pressure ratio and fractional flow reserve.