A method and system for determining the timing of intervention with a percutaneous mechanical circulation aid device

Abstract

This invention provides a method and system for determining the timing of percutaneous mechanical circulatory support device (PCOS) intervention, relating to the field of biomedical technology. The method includes: acquiring tomographic images of the patient's blood vessels; establishing a three-dimensional vascular model of the patient's blood vessels based on the tomographic images, combined with physical conservation laws and Newton's second law; automatically segmenting the three-dimensional vascular model into tetrahedral meshes to establish a patient-specific three-dimensional vascular numerical simulation model; real-time acquisition of the patient's physiological parameters and medical record examination results; dynamic simulation combining the patient-specific three-dimensional vascular numerical simulation model, physiological parameters, patient medical record examination results, and a pre-set PCOS numerical model, outputting patient functional data; and determining the timing of PCOS intervention based on the patient functional data. This invention can assist physicians in making clinical decisions regarding PCOS intervention, improving the success rate of treating patients with circulatory failure.

Description

Technical Field

[0001] This invention relates to the field of biomedical technology, and in particular to a method and system for determining the timing of intervention with a percutaneous mechanical circulatory support device. Background Technology

[0002] Percutaneous mechanical circulatory support devices (PCMPs) are medical devices implanted in the human body through skin puncture to provide cardiac or circulatory support. They are an important "bridge" treatment for patients with cardiogenic shock or late-stage heart failure. The decision-making method for PCMP intervention is a scientific approach based on real-time data monitoring, hemodynamic simulation, and decision-making algorithms, which improves tissue and organ perfusion by correcting hemodynamic disturbances.

[0003] In complex clinical settings, the ability to quickly and accurately determine the timing and type of percutaneous mechanical circulatory devices is of great significance for the scientific and precise nature of clinical decision-making, enabling individualized treatment, reducing medical costs and patient burden, and promoting technological innovation in the field of percutaneous mechanical circulatory devices.

[0004] However, the implementation of hemodynamically individualized treatment plans for percutaneous mechanical circulatory assist devices is currently limited. Because clinicians need to comprehensively assess complex data indicators such as the patient's circulatory function, organ oxygen supply, and blood parameters, there is still a lag in clinical decisions regarding the timing of percutaneous mechanical circulatory device implantation, type selection, and management of complications. This may delay the patient's optimal treatment time and fail to provide clinical decision support for the selection or combined use of percutaneous mechanical circulatory assist devices. This can lead to serious complications such as increased left ventricular afterload and ischemia and hypoxia of vital organs, further increasing medical risks and reducing the success rate of treating patients with circulatory failure. Summary of the Invention

[0005] To address the limitations of existing technologies in implementing hemodynamically individualized treatment plans for percutaneous mechanical circulatory assist devices (PCIs), and the lag in clinical decisions regarding the timing of PCI implantation, type selection, and complication management, which may delay optimal treatment for patients and hinder clinical decision support for PCI selection or combined use, leading to serious complications such as increased left ventricular afterload and ischemia-hypoxia of vital organs, further increasing medical risks and reducing the success rate of treating patients with circulatory failure, this invention provides a method and system for determining the timing of PCI intervention.

[0006] The technical solutions provided by the embodiments of the present invention are as follows:

[0007] First aspect

[0008] This invention provides a method for determining the timing of intervention with a percutaneous mechanical circulation assist device, comprising:

[0009] S1: Acquire tomographic images of the patient's blood vessels;

[0010] S2: Based on the tomographic image data, a three-dimensional vascular model of the patient's blood vessels is established by combining the laws of physical conservation and Newton's second law.

[0011] S3: Automatically segment the three-dimensional vascular model into tetrahedral meshes to establish a patient-specific three-dimensional vascular numerical simulation model;

[0012] S4: Real-time collection of patients' physiological parameters and patient medical record examination results;

[0013] S5: Combining patient-specific three-dimensional vascular numerical simulation models, physiological parameters, patient medical record examination results, and pre-set percutaneous mechanical circulation assist device numerical models, the system performs dynamic simulation of the patient's blood vessels and outputs patient functional data.

[0014] S6: Determine the timing of intervention with the percutaneous mechanical circulation assist device based on the patient's functional data.

[0015] Second aspect

[0016] This invention provides a decision-making system for determining the timing of intervention of a percutaneous mechanical circulation assist device, comprising:

[0017] processor;

[0018] The memory stores computer-readable instructions, which, when executed by a processor, implement a decision-making method for the timing of intervention of the percutaneous mechanical circulation auxiliary device as described in the first aspect.

[0019] Third aspect

[0020] The present invention provides a computer-readable storage medium having a computer program stored thereon, which, when executed by a processor, implements a decision-making method for the timing of intervention of a percutaneous mechanical circulation auxiliary device as described in the first aspect.

[0021] The beneficial effects of the technical solutions provided in the embodiments of the present invention include at least the following:

[0022] In this invention, tomographic images of the patient's blood vessels are acquired, and a three-dimensional vascular model is established using physical conservation laws and Newton's second law. The three-dimensional vascular model is then automatically segmented into tetrahedral meshes to create a patient-specific three-dimensional vascular numerical simulation model. The patient's physiological parameters and medical records are collected in real time. By combining the patient-specific three-dimensional vascular numerical simulation model, physiological parameters, medical records, and a pre-installed numerical model of a percutaneous mechanical circulatory support device (PCMP), dynamic simulation is performed, outputting patient functional data to determine the optimal intervention time for the PCMP. This improves the therapeutic effect of PCMP and assists physicians in making individualized, digitalized, and precise clinical decisions regarding the timing, type, and management of complications related to PCMP implantation. By combining the numerical simulation model with physiological data to establish a patient-specific hemodynamic assessment solution, this invention assists physicians in making clinical decisions regarding PCMP, thereby better utilizing the PCMP, increasing the success rate of treating patients with circulatory failure, reducing medical risks, accurately predicting the optimal treatment time, and achieving individualized treatment. Attached Figure Description

[0023] To more clearly illustrate the technical solutions in the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0024] Figure 1 A flowchart illustrating a method for determining the timing of intervention with a percutaneous mechanical circulation assist device, provided in an embodiment of the present invention;

[0025] Figure 2 This is a schematic diagram of a method for determining the timing of intervention of a percutaneous mechanical circulation assist device according to an embodiment of the present invention;

[0026] Figure 3 This is a schematic diagram of the decision system for the timing of intervention of a percutaneous mechanical circulation auxiliary device, provided in an embodiment of the present invention. Detailed Implementation

[0027] The technical solution of the present invention will now be described with reference to the accompanying drawings.

[0028] In embodiments of the present invention, words such as "exemplarily," "for example," etc., are used to indicate that something is an example, illustration, or description. Any embodiment or design described as "exemplary" in the present invention should not be construed as being more preferred or advantageous than other embodiments or designs. Specifically, the use of the word "exemplary" is intended to present the concept in a concrete manner. Furthermore, in embodiments of the present invention, the meaning expressed by "and / or" can be both, or either one.

[0029] To make the technical problems, technical solutions and advantages of the present invention clearer, a detailed description will be given below in conjunction with the accompanying drawings and specific embodiments.

[0030] Reference manual attached Figure 1 The diagram shows a flowchart illustrating a method for determining the timing of intervention of a percutaneous mechanical circulation auxiliary device according to an embodiment of the present invention.

[0031] This invention provides a method for determining the intervention time of a percutaneous mechanical circulation assistive device. This method can be implemented by a device for determining the intervention time of the percutaneous mechanical circulation assistive device, which can be a terminal or a server. The processing flow of the method for determining the intervention time of the percutaneous mechanical circulation assistive device may include the following steps:

[0032] S1: Acquire tomographic images of the patient's blood vessels.

[0033] Among them, tomographic image data refers to cross-sectional images of blood vessels obtained using medical imaging technologies (such as CT, MRI, etc.). These images record the structure and spatial distribution of blood vessels through multi-slice scanning. By acquiring the patient's tomographic image data, high-resolution and individualized vascular anatomy information can be provided, laying the foundation for subsequent three-dimensional model construction. It is non-invasive, safe and reliable, and can accurately reflect the actual morphology and lesion of the patient's blood vessels.

[0034] In one possible implementation, the patient's blood vessels include the aorta and its branches.

[0035] The aorta is the largest artery in the human body, originating from the left ventricle of the heart. It is responsible for transporting oxygen-rich blood throughout the body. Branch vessels refer to the various branches that branch off from the aorta, and are responsible for transporting blood to specific organs and tissues.

[0036] It should be noted that modeling and analyzing these blood vessels in simulation and decision-making methods helps to assess hemodynamic status and organ perfusion.

[0037] S2: Based on the tomographic image data, a three-dimensional vascular model of the patient's blood vessels is established by combining the laws of physical conservation and Newton's second law.

[0038] Among them, the laws of conservation of physical energy are the basic physical laws that describe the conservation of mass, energy and momentum in nature. In blood flow modeling, the main laws involved are the mass conservation equation (continuity equation) and the momentum conservation equation, which are used to describe the flow characteristics of blood in blood vessels. Newton's second law describes the motion and deformation of the blood vessel wall under the action of force in blood vessel modeling. The three-dimensional blood vessel model is a three-dimensional digital model of blood vessels constructed based on tomographic scan data and physical equations, reflecting the true morphology and physiological characteristics of the patient's blood vessels.

[0039] It should be noted that by combining the patient's tomographic image data with the laws of conservation of mass and Newton's second law, a patient-specific three-dimensional vascular model can be constructed. This model can accurately reproduce the morphology of the patient's blood vessels and the physical laws of blood flow, providing a reliable data foundation for subsequent numerical simulations. This model can simulate hemodynamic states under different conditions, helping doctors accurately assess the patient's vascular function and health status.

[0040] Reference manual attached Figure 2 The diagram shows a structural schematic of a decision-making method for the timing of intervention of a percutaneous mechanical circulation auxiliary device provided in an embodiment of the present invention.

[0041] Figure 2 The image processing and model storage module can process tomographic images of the patient's aorta and its branches. Using computer algorithms such as convolution and reconstruction, it stitches and combines multiple consecutive two-dimensional images, and generates a three-dimensional vascular model with spatial information through image post-processing methods such as maximum density projection, volumetric rendering, and surface rendering. The system uses Python programming to call the Fluent Mesh software's pre-built function library for automatic tetrahedral mesh segmentation, thereby establishing a patient-specific 3D numerical simulation model of the blood vessels. If patient-specific image data is unavailable, the system's database stores basic vascular models covering heights from 155cm to 185cm, allowing clinicians to select a model that best matches the patient's characteristics for clinical decision support.

[0042] The physiological data detection module is divided into two parts: physiological data monitoring and case data extraction. The physiological monitoring part monitors the patient's physiological parameters in real time through a vital sign monitoring device, mainly including blood pressure, pulse, respiratory rate, and blood oxygen saturation. The case data extraction module retrieves important test and examination results from the medical record system, mainly including echocardiography, blood gas analysis, myocardial enzyme spectrum, liver function, and kidney function.

[0043] The evaluation and display module stores numerical models of percutaneous mechanical circulatory support devices such as arterial-venous extracorporeal membrane oxygenation (VA-ECMO), intra-aortic balloon pump (IABP), Impella left ventricular assist device, and Tandemheart system. The evaluation module can combine vascular numerical models, physiological data, and percutaneous mechanical circulatory support device numerical models to output and display left ventricular pressure load, perfusion of various organs, and oxygen supply distribution of various organs.

[0044] Results output and display are used to visualize the assessment data, making it easier for clinicians to understand the results intuitively and determine the timing and approach for percutaneous mechanical circulation assist device intervention.

[0045] It should be noted that by combining numerical simulation models with physiological data to establish patient-specific hemodynamic assessment solutions, doctors can make clinical decisions regarding percutaneous mechanical circulatory support devices, thereby better leveraging the role of percutaneous mechanical circulatory support devices and improving the success rate of treating patients with circulatory failure.

[0046] S3: Automatically segment the three-dimensional vascular model into tetrahedral meshes to establish a patient-specific three-dimensional vascular numerical simulation model.

[0047] Among them, automatic tetrahedral mesh segmentation is a numerical modeling technique that divides complex three-dimensional structures into small tetrahedral elements for finite element analysis or computational fluid dynamics (CFD) simulation. Patient-specific three-dimensional vascular numerical simulation models are simulation models built on the basis of three-dimensional vascular models by introducing individualized physiological data (such as blood flow velocity, blood pressure, etc.) to simulate the actual hemodynamic state of patients.

[0048] It should be noted that by using the automatic tetrahedral mesh segmentation technology, the patient's three-dimensional vascular model can be transformed into a structured model suitable for numerical simulation. This enables high-precision calculations while ensuring the fidelity of vascular geometric details. The automated tetrahedral mesh segmentation reduces human error and improves modeling efficiency, allowing complex three-dimensional structures to be quickly used for hemodynamic simulation. Combined with the patient's individual characteristics, this numerical simulation model can accurately predict blood flow and organ perfusion status, providing clinicians with scientific and reliable decision support and significantly improving the accuracy and efficiency of diagnosis and treatment.

[0049] In one possible implementation, the patient-specific three-dimensional vascular numerical simulation model is specifically as follows:

[0050] According to the laws of conservation of physical properties, the specific constraints of the patient-specific three-dimensional vascular numerical simulation model are as follows:

[0051]

[0052] in, This represents the rate of change of blood density over time. p represents the divergence term of the blood fluid velocity field. f The density of blood is represented by p, and blood pressure is represented by u. f Represents the blood velocity vector. This represents the partial derivative of the blood velocity vector with respect to time. The term represents the convection term in the velocity field, and u represents the viscosity of the blood. F represents the Laplace term of the velocity vector. f This represents the total volumetric force vector acting on the blood.

[0053] According to Newton's second law, the governing equations for the vessel wall in the patient-specific three-dimensional numerical simulation model are as follows:

[0054]

[0055] Where, p s This represents the density of the arterial wall. The second-order time partial derivative of the arterial wall velocity vector. The stress tensor representing the arterial wall. F represents the divergence term of the stress tensor. s This represents the volumetric force vector.

[0056] The specific constraints of the fluid-solid coupling interface in the patient-specific three-dimensional vascular numerical simulation model are as follows:

[0057]

[0058] Where, d s d represents the displacement of the arterial wall at the fluid-structure coupling interface. f This represents the displacement of blood at the fluid-structure coupling interface, where n represents the unit normal vector of the interface. This represents the stress in the arterial wall at the fluid-structure coupling interface. This represents the stress of the fluid at the fluid-structure coupling interface.

[0059] It should be noted that by using the equations of conservation of mass and momentum, the flow behavior of blood in blood vessels can be accurately simulated, including key characteristics such as flow velocity and pressure distribution. By combining Newton's second law, the governing equations of the arterial wall can be established, which can describe the deformation behavior of the blood vessel wall under the action of blood flow pressure. Through the fluid-solid coupling interface condition, the motion and mechanical properties of the fluid (blood) and the solid (arterial wall) at the interface are kept consistent, thus enhancing the physical realism of the model.

[0060] S4: Real-time collection of patients' physiological parameters and patient medical record examination results.

[0061] Physiological parameters refer to the changes in a patient's current physiological parameters acquired in real time during treatment through monitoring equipment, ensuring the timeliness and accuracy of the data. Patient medical record examination results are the patient's historical medical records and examination data. By collecting patients' physiological parameters and medical record examination results in real time, a precise and personalized data foundation is provided for subsequent dynamic simulation and decision-making. Compared with single static collection, real-time collection can reflect changes in the patient's condition in a timely manner, especially in cases of rapid dynamic changes such as acute circulatory failure, which can help doctors quickly capture key states and optimize treatment plans.

[0062] In one possible implementation, the physiological parameters specifically include: blood pressure, pulse, respiratory rate, and blood oxygen saturation.

[0063] Among them, blood pressure reflects the pressure change of blood in the arteries and is a key indicator for assessing circulatory function; pulse is the external manifestation of the heart rate and is closely related to heart rate; respiratory rate refers to the number of breaths per minute and is used to assess the patient's respiratory function; and blood oxygen saturation reflects the ability of blood to transport oxygen and is an important parameter for assessing oxygen supply.

[0064] It should be noted that the greatest advantage of collecting physiological parameters is that it can reflect the patient's physiological state in real time, dynamically and accurately, providing doctors with a scientific basis for decision-making, improving treatment effectiveness, and ensuring patient safety. This monitoring method is particularly suitable for the management of rapidly changing acute conditions and is an important foundation for precision medicine.

[0065] In one possible implementation, the patient's medical record examination results specifically include: echocardiography, blood gas analysis, myocardial enzyme profile, liver function, and kidney function.

[0066] Among them, echocardiography is used to assess cardiac structure and function, blood gas analysis measures the concentration of oxygen and carbon dioxide in the blood to assess respiratory and metabolic status, myocardial enzyme profile reflects the degree of damage to myocardial cells, and liver and kidney function are used to assess the status of vital organs.

[0067] It should be noted that integrating medical record examination results helps to comprehensively assess the patient's health status, and combining real-time data to form a complete physiological and pathological analysis provides important support for the scientific judgment of the timing of intervention with assistive devices. This not only improves the accuracy of treatment, but also significantly improves clinical efficiency and the success rate of treatment.

[0068] S5: Combining patient-specific three-dimensional vascular numerical simulation models, physiological parameters, patient medical records, and numerical models of pre-installed percutaneous mechanical circulation assist devices, dynamic simulation of patient blood vessels is performed, and patient functional data is output.

[0069] Among them, the numerical model of the pre-installed percutaneous mechanical circulation assist device is a simulation model of the working characteristics and parameters of different assist devices (such as VA-ECMO, IABP, Impella, etc.) to predict the effect of the device. The patient functional data refers to the simulation output data, including left ventricular pressure load, perfusion of various organs, oxygen supply distribution, etc., as the basis for clinical decision-making.

[0070] It should be noted that the advantage of dynamic simulation, which combines patient-specific numerical models, physiological parameters, medical record examination results, and assistive device models, is that it can accurately predict the patient's hemodynamic status and organ function changes. Compared with simple physiological monitoring, dynamic simulation can assess the implantation effect of assistive devices in advance and help doctors optimize treatment strategies.

[0071] In one possible implementation, patient functional data includes left ventricular pressure load, organ perfusion, and organ oxygen supply distribution data.

[0072] Among them, the patient's left ventricular pressure load refers to the pressure burden that the left ventricle needs to bear to overcome resistance when pumping blood. It is a key indicator for assessing cardiac function. The perfusion of each organ refers to the blood flow received by each organ within a certain period of time. It is usually used to reflect the blood supply of organs. The oxygen supply distribution data of each organ refers to the distribution of oxygen obtained by different organs. It is usually expressed as oxygen partial pressure or blood oxygen content.

[0073] It should be noted that these indicators together constitute the patient's core functional data, used to comprehensively assess their blood circulation status and provide key evidence for clinical decision-making.

[0074] In one possible implementation, the formula for calculating the perfusion volume of each organ is as follows:

[0075]

[0076] Where Q(t) represents the blood flow velocity through the exit surface at time t, v represents the blood flow velocity on each grid of the exit surface, m represents the normal unit vector of each grid, ds represents the difference area element of the exit surface, and flow renal dt represents the blood flow in the renal artery during one cardiac cycle, HR represents the heart rate obtained from electrocardiogram monitoring or echocardiography.

[0077] In one possible implementation, the formula for calculating the oxygen supply distribution data of each organ is as follows:

[0078]

[0079] in, PO₂ represents the rate of change of oxygen partial pressure with time t, and PO₂ represents the oxygen partial pressure in the blood. Represents the blood flow velocity field. This represents the gradient of oxygen partial pressure, and Db represents the diffusion coefficient of oxygen in the blood, specifically 1.2e. -9 m 2 / s.

[0080] Specifically, the formula embodies two key aspects of oxygen transport, integrating the effects of advection caused by blood movement and diffusion caused by oxygen molecule concentration gradients. By using this formula, we can simulate the transient behavior of oxygen distribution in the blood, thereby gaining a deeper understanding of the dynamics of oxygen delivery to tissues.

[0081] It should be noted that by integrating multidimensional data, the simulation results have individualized characteristics and can reflect the patient's unique physiological state. This process not only improves the scientific nature of clinical decision-making but also significantly reduces treatment risks, ensures the precise timing of device intervention, and improves the success rate and treatment effect of patient rescue.

[0082] S6: Determine the timing of intervention with the percutaneous mechanical circulation assist device based on the patient's functional data.

[0083] Intervention time refers to the optimal time for implanting a percutaneous mechanical circulatory assist device (PCA) into the patient. By analyzing the patient's functional data, the optimal intervention time for PCA is determined. Its advantage lies in improving the scientific nature and precision of treatment. Compared with traditional experience-based decision-making, decision-making methods based on real-time data and simulation results can accurately identify the patient's physiological limits and avoid irreversible damage such as organ ischemia and hypoxia caused by late intervention, thereby improving the success rate of treatment and long-term prognosis.

[0084] Specifically, clinicians can combine the results output by this system with their clinical experience to decide when to insert or discontinue the percutaneous mechanical circulatory support device, thereby preventing ischemic and hypoxic damage to vital organs such as the brain, liver, and kidneys.

[0085] In one specific embodiment, the model calculation is configured as follows: the blood vessel wall is represented by an isotropic linear elastic material with a density of 1100 kg / m³, an elastic modulus of 6 MPa, and a Poisson's ratio of 0.42. Blood is an incompressible Newtonian fluid with a density of 1060 kg / m³ and a dynamic viscosity of 0.0035 Pa·s. Fluent is selected as the numerical simulation solver for the blood components, and the Couple algorithm is used for velocity-pressure coupling. The residuals of the continuity and momentum equations are converged using a convergence criterion of 0.001. To address the problem of fluid domain boundary mesh changes caused by significant blood vessel deformation, dynamic mesh adaptation is enabled.

[0086] The simulation process involved coupling Fluent (ANSYS) and Mechanical (ANSYS) using a coupling module and performing transient calculations. The two solvers swapped blood pressure and vessel wall displacement at each time step until the root mean square error was less than 0.01, indicating convergence. Two cardiac cycles were calculated, with the second cycle used for hemodynamic analysis. Each cycle lasted 0.8 seconds, with a time step of 0.001 seconds.

[0087] The model's inlet boundary conditions are based on the flow velocity at the aortic valve, derived from echocardiography of patients with heart failure; the VA-ECMO flow velocity can be adjusted as needed. Left ventricular afterload, which varies periodically with the cardiac cycle, is used as the exit boundary condition for the entire model.

[0088] The beneficial effects of the technical solutions provided in the embodiments of the present invention include at least the following:

[0089] In this invention, tomographic images of the patient's blood vessels are acquired, and a three-dimensional vascular model is established using physical conservation laws and Newton's second law. The three-dimensional vascular model is then automatically segmented into tetrahedral meshes to create a patient-specific three-dimensional vascular numerical simulation model. The patient's physiological parameters and medical records are collected in real time. By combining the patient-specific three-dimensional vascular numerical simulation model, physiological parameters, medical records, and a pre-installed numerical model of a percutaneous mechanical circulatory support device (PCMP), dynamic simulation is performed, outputting patient functional data to determine the optimal intervention time for the PCMP. This improves the therapeutic effect of PCMP and assists physicians in making individualized, digitalized, and precise clinical decisions regarding the timing, type, and management of complications related to PCMP implantation. By combining the numerical simulation model with physiological data to establish a patient-specific hemodynamic assessment solution, this invention assists physicians in making clinical decisions regarding PCMP, thereby better utilizing the PCMP, increasing the success rate of treating patients with circulatory failure, reducing medical risks, accurately predicting the optimal treatment time, and achieving individualized treatment.

[0090] Reference manual attached Figure 3 The diagram shows a structural schematic of a decision system for the timing of intervention of a transdermal mechanical circulation auxiliary device provided by the present invention.

[0091] The present invention also provides a decision system 20 for determining the timing of intervention of a percutaneous mechanical circulation assist device, applied to the above-mentioned decision method for determining the timing of intervention of a percutaneous mechanical circulation assist device, comprising:

[0092] Processor 201.

[0093] The memory 202 stores computer-readable instructions that, when executed by the processor 201, implement the method for deciding the timing of intervention of the percutaneous mechanical circulation assist device as described in the method embodiment.

[0094] The decision system 20 for the timing of intervention of the percutaneous mechanical circulation auxiliary device provided by the present invention can execute the above-mentioned decision method for the timing of intervention of the percutaneous mechanical circulation auxiliary device and achieve the same or similar technical effects. To avoid repetition, the present invention will not elaborate further.

[0095] The beneficial effects of the technical solutions provided in the embodiments of the present invention include at least the following:

[0096] In this invention, tomographic images of the patient's blood vessels are acquired, and a three-dimensional vascular model is established using physical conservation laws and Newton's second law. The three-dimensional vascular model is then automatically segmented into tetrahedral meshes to create a patient-specific three-dimensional vascular numerical simulation model. The patient's physiological parameters and medical records are collected in real time. By combining the patient-specific three-dimensional vascular numerical simulation model, physiological parameters, medical records, and a pre-installed numerical model of a percutaneous mechanical circulatory support device (PCMP), dynamic simulation is performed, outputting patient functional data to determine the optimal intervention time for the PCMP. This improves the therapeutic effect of PCMP and assists physicians in making individualized, digitalized, and precise clinical decisions regarding the timing, type, and management of complications related to PCMP implantation. By combining the numerical simulation model with physiological data to establish a patient-specific hemodynamic assessment solution, this invention assists physicians in making clinical decisions regarding PCMP, thereby better utilizing the PCMP, increasing the success rate of treating patients with circulatory failure, reducing medical risks, accurately predicting the optimal treatment time, and achieving individualized treatment.

[0097] It should be understood that the processor in the embodiments of the present invention can be a central processing unit (CPU), or it can be other general-purpose processors, digital signal processors (DSPs), application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), or other programmable logic devices, discrete gate or transistor logic devices, discrete hardware components, etc. The general-purpose processor can be a microprocessor or any conventional processor.

[0098] It should also be understood that the memory in the embodiments of the present invention can be volatile memory or non-volatile memory, or may include both volatile and non-volatile memory. The non-volatile memory can be read-only memory (ROM), programmable read-only memory (PROM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), or flash memory. The volatile memory can be random access memory (RAM), which is used as an external cache. By way of example, but not limitation, many forms of random access memory (RAM) are available, such as static RAM (SRAM), dynamic RAM (DRAM), synchronous DRAM (SDRAM), double data rate synchronous DRAM (DDR SDRAM), enhanced synchronous DRAM (ESDRAM), synchronous linked DRAM (SLDRAM), and direct rambus RAM (DR RAM).

[0099] The above embodiments can be implemented, in whole or in part, by software, hardware (such as circuits), firmware, or any other combination thereof. When implemented using software, the above embodiments can be implemented, in whole or in part, as a computer program product. A computer program product includes one or more computer instructions or computer programs. When the computer instructions or computer programs are loaded or executed on a computer, all or part of the flow or function according to the embodiments of the present invention is generated. The computer can be a general-purpose computer, a special-purpose computer, a computer network, or other programmable device. Computer instructions can be stored in a computer-readable storage medium or transmitted from one computer-readable storage medium to another. For example, computer instructions can be transmitted from one website, computer, server, or data center to another website, computer, server, or data center via wired (e.g., infrared, wireless, microwave, etc.) means. A computer-readable storage medium can be any available medium that a computer can access or a data storage device such as a server or data center that includes one or more sets of available media. Available media can be magnetic media (e.g., floppy disks, hard disks, magnetic tapes), optical media (e.g., DVDs), or semiconductor media. Semiconductor media can be solid-state drives.

[0100] It should be understood that the term "and / or" in this article is merely a description of the relationship between related objects, indicating that three relationships can exist. For example, A and / or B can represent: A existing alone, A and B existing simultaneously, or B existing alone. A and B can be singular or plural. Additionally, the character " / " in this article generally indicates an "or" relationship between the preceding and following related objects, but it can also represent an "and / or" relationship. Please refer to the context for a more accurate understanding.

[0101] In this invention, "at least one" means one or more, and "more than one" means two or more. "At least one of the following" or similar expressions refer to any combination of these items, including any combination of a single item or a plurality of items. For example, at least one of a, b, or c can represent: a, b, c, ab, ac, bc, or abc, where a, b, and c can be a single item or multiple items.

[0102] It should be understood that, in various embodiments of the present invention, the order of the above-mentioned process numbers does not imply the order of execution. The execution order of each process should be determined by its function and internal logic, and should not constitute any limitation on the implementation process of the embodiments of the present invention.

[0103] Those skilled in the art will recognize that the units and algorithm steps of the various examples described in conjunction with the embodiments disclosed herein can be implemented in electronic hardware, or a combination of computer software and electronic hardware. Whether these functions are implemented in hardware or software depends on the specific application and design constraints of the technical solution. Those skilled in the art can use different methods to implement the described functions for each specific application, but such implementations should not be considered beyond the scope of this invention.

[0104] Those skilled in the art will clearly understand that, for the sake of convenience and brevity, the specific working processes of the devices, apparatuses, and units described above can be referred to the corresponding processes in the foregoing method embodiments, and will not be repeated here.

[0105] In the embodiments provided by this invention, it should be understood that the disclosed devices, apparatuses, and methods can be implemented in other ways. For example, the apparatus embodiments described above are merely illustrative; for instance, the division of units is only a logical functional division, and in actual implementation, there may be other division methods. For example, multiple units or components may be combined or integrated into another device, or some features may be ignored or not executed. Furthermore, the coupling or direct coupling or communication connection shown or discussed may be through some interfaces; the indirect coupling or communication connection between devices or units may be electrical, mechanical, or other forms.

[0106] The units described as separate components may or may not be physically separate. The components shown as units may or may not be physical units; that is, they may be located in one place or distributed across multiple network units. Some or all of the units can be selected to achieve the purpose of this embodiment according to actual needs.

[0107] In addition, the functional units in the various embodiments of the present invention can be integrated into one processing unit, or each unit can exist physically separately, or two or more units can be integrated into one unit.

[0108] If a function is implemented as a software functional unit and sold or used as an independent product, it can be stored in a computer-readable storage medium. Based on this understanding, the technical solution of this invention, or the part that contributes to the prior art, or a part of the technical solution, can be embodied in the form of a software product. This computer software product is stored in a storage medium and includes several instructions to cause a computer device (which may be a personal computer, server, or network device, etc.) to execute all or part of the steps of the methods of the various embodiments of this invention. The aforementioned storage medium includes various media capable of storing program code, such as USB flash drives, portable hard drives, read-only memory (ROM), random access memory (RAM), magnetic disks, or optical disks.

[0109] This invention provides a computer-readable storage medium storing a computer program that, when executed by a processor, implements a method for determining the timing of intervention of a transdermal mechanical circulation aid as described in the method embodiments.

[0110] The present invention provides a computer-readable storage medium that can implement the steps and effects of the decision-making method for the timing of intervention of the percutaneous mechanical circulation auxiliary device in the above-described method embodiments. To avoid repetition, the present invention will not elaborate further.

[0111] The beneficial effects of the technical solutions provided in the embodiments of the present invention include at least the following:

[0112] In this invention, tomographic images of the patient's blood vessels are acquired, and a three-dimensional vascular model is established using physical conservation laws and Newton's second law. The three-dimensional vascular model is then automatically segmented into tetrahedral meshes to create a patient-specific three-dimensional vascular numerical simulation model. The patient's physiological parameters and medical records are collected in real time. By combining the patient-specific three-dimensional vascular numerical simulation model, physiological parameters, medical records, and a pre-installed numerical model of a percutaneous mechanical circulatory support device (PCMP), dynamic simulation is performed, outputting patient functional data to determine the optimal intervention time for the PCMP. This improves the therapeutic effect of PCMP and assists physicians in making individualized, digitalized, and precise clinical decisions regarding the timing, type, and management of complications related to PCMP implantation. By combining the numerical simulation model with physiological data to establish a patient-specific hemodynamic assessment solution, this invention assists physicians in making clinical decisions regarding PCMP, thereby better utilizing the PCMP, increasing the success rate of treating patients with circulatory failure, reducing medical risks, accurately predicting the optimal treatment time, and achieving individualized treatment.

[0113] The above are merely specific embodiments of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in the present invention should be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

[0114] The following points need to be explained:

[0115] (1) The accompanying drawings of the embodiments of the present invention only involve the structures involved in the embodiments of the present invention. Other structures can refer to the general design.

[0116] (2) For clarity, the thickness of layers or regions is enlarged or reduced in the drawings used to describe embodiments of the invention, i.e., these drawings are not drawn to scale. It is understood that when an element such as a layer, film, region or substrate is referred to as being “above” or “below” another element, the element may be “directly” located “above” or “below” the other element or there may be intermediate elements.

[0117] (3) Where there is no conflict, the embodiments of the present invention and the features in the embodiments can be combined with each other to obtain new embodiments.

[0118] The above are merely specific embodiments of the present invention, but the scope of protection of the present invention is not limited thereto. The scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. A method for determining the timing of intervention of a percutaneous mechanical circulation auxiliary device, characterized in that, include: S1: Acquire tomographic images of the patient's blood vessels; S2: Based on the tomographic image data, and in conjunction with the laws of conservation of physical laws and Newton's second law, establish a three-dimensional vascular model of the patient's blood vessels; S3: Automatically segment the three-dimensional vascular model into tetrahedral meshes to establish a patient-specific three-dimensional vascular numerical simulation model; The patient-specific three-dimensional vascular numerical simulation model is as follows: According to the aforementioned physical conservation law, the specific constraints of the patient-specific three-dimensional vascular numerical simulation model are as follows: ； in, This represents the rate of change of blood density over time. The term representing the divergence of the blood fluid velocity field. The density of blood is represented by p, and blood pressure is represented by u. f Represents the blood velocity vector. This represents the partial derivative of the blood velocity vector with respect to time. The convection term represents the velocity field. Indicates blood viscosity. F represents the Laplace term of the velocity vector. f This represents the total volumetric force vector acting on the blood. According to Newton's second law, the governing equations of the vessel wall in the patient-specific three-dimensional vascular numerical simulation model are as follows: ； in, This represents the density of the arterial wall. The second-order time partial derivative of the arterial wall velocity vector. The stress tensor representing the arterial wall. The divergence term of the stress tensor is represented by Fs, and the volumetric force vector is represented by Fs. The specific constraints of the fluid-solid coupling interface in the patient-specific three-dimensional vascular numerical simulation model are as follows: ； Where, d s d represents the displacement of the arterial wall at the fluid-structure coupling interface. f This represents the displacement of blood at the fluid-structure coupling interface, where n represents the unit normal vector of the interface. This represents the stress in the arterial wall at the fluid-structure coupling interface. This represents the stress in the fluid at the fluid-structure coupling interface; S4: Real-time collection of patients' physiological parameters and patient medical record examination results; S5: Combining the patient-specific three-dimensional vascular numerical simulation model, the physiological parameters, the patient's medical record examination results, and the numerical model of the pre-set percutaneous mechanical circulation assist device, perform dynamic simulation of the patient's blood vessels and output patient functional data; The physiological parameters specifically include: blood pressure, pulse, respiratory rate, and blood oxygen saturation; The specific examination results of the patient's medical records include: echocardiography, blood gas analysis, myocardial enzyme spectrum, liver function and kidney function; S6: Determine the intervention time of the percutaneous mechanical circulation assist device based on the patient's functional data; The patient's functional data includes left ventricular pressure load, perfusion volume of each organ, and oxygen supply distribution data of each organ. The specific formulas for calculating the perfusion volume of each organ are as follows: ； Where Q(t) represents the blood flow velocity through the exit surface at time t, v represents the blood flow velocity on each grid of the exit surface, m represents the normal unit vector of each grid, ds represents the difference area element of the exit surface, and flow renal It represents the blood flow in the renal artery during one cardiac cycle, dt represents a small increment of time, and HR represents the heart rate obtained from electrocardiogram monitoring or echocardiography. The specific formula for calculating the oxygen supply distribution data of each organ is as follows: ； in, PO₂ represents the rate of change of oxygen partial pressure with time t, and PO₂ represents the oxygen partial pressure in the blood. Represents the blood flow velocity field. This represents the gradient of oxygen partial pressure, and Db represents the diffusion coefficient of oxygen in the blood, specifically 1.2e. −9 m 2 / s.

2. The method for determining the timing of intervention of the percutaneous mechanical circulation auxiliary device according to claim 1, characterized in that, The patient's blood vessels include the aorta and its branches.

3. A decision-making system for the timing of intervention of a percutaneous mechanical circulation auxiliary device, characterized in that, include: processor; A memory storing computer-readable instructions, which, when executed by the processor, implement a method for deciding the timing of intervention of a percutaneous mechanical circulation aid as described in any one of claims 1 to 2.

4. A computer-readable storage medium having a computer program stored thereon, characterized in that, When executed by the processor, the program implements the decision-making method for the timing of intervention of the percutaneous mechanical circulation assist device as described in any one of claims 1 to 2.

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