RU2725917C1 - Method for numerical modelling of transcatheter implantation of patient's heart valve - Google Patents

Abstract

FIELD: medicine.SUBSTANCE: present invention relates to medicine and can be used at the cardiac valve implantation planning stage in heart modelling using medical images and, in particular, to complex, patient-specific modelling of transcatheter prosthetic repair of aortic valve based on medical image data. Disclosed is a method of scheduling transcatheter implantation of patient's heart valve, involving computer modelling of patient's heart with creation of interactive model of heart at preoperative operation planning stage, collection and fixation of geometrical and functional parameters of heart of patient and its vessels, as well as parameters of hemodynamics of heart and processing of obtained results and planning stages of heart valve reconstruction. Preoperative selection of the trans-vessel delivery system is carried out, namely physical, mechanical, fatigue and strength properties of its separate components are determined, simulating movement of the delivery catheter along the guide, analysing the interaction of the delivery system and the vascular bed of the patient - the descending aorta with detecting the stress-strain state of the aorta, cardiac and vascular anomalies, and detecting and preventing the risk of vascular complications and haemodynamic effects, and at the final stage, constructing a graphic diagram stress-strain state with detecting the probability of injuring the biological components of the heart and the risk of conduction disorders.EFFECT: invention provides predicting and reducing risks of transcatheter interventions on heart valves and determining the most optimal prosthesis models at the preoperative planning stage.1 cl, 16 dwg

Description

The present invention relates to medicine, and can be used at the stage of planning the implantation of the heart valve when modeling the heart using medical images and, in particular, to a comprehensive, patient-specific modeling of transcatheter aortic valve prosthetics based on medical image data.

Acquired aortic valve defects are the most common type of lesion among all valve positions. One of the most promising methods of treating this defect is minimally invasive prosthetics using transcatheter access through the vascular system. Such an intervention significantly reduces the risks of prosthetics compared with open heart surgery, which allows for high-risk patients. Despite its advantages, transcatheter prosthesis of the aortic valve is associated with specific complications due to the specifics of implantation - without direct visual control and the possibility of direct correction of the procedure. Medical imaging methods, such as computed tomography (CT), magnetic resonance imaging (MRI) and ultrasound, can be used to obtain a large amount of morphological and functional data on the anatomy of the implantation site with high spatial-temporal resolution at the stage of preoperative planning.

There is a known technique for patient-specific numerical modeling of heart function and evaluation of its changes as a result of various surgical interventions (US Patent No. US 2008319308A1 "Patient-specific image-based computational modeling and techniques for human heart surgery optimization", publication date 12/25/2008). The basis of the technique is a combination of two elements - the reconstruction of three-dimensional computer anatomy of the heart of the end patient by non-invasive methods and numerical simulation of the hemodynamics of the heart. The technique suggests the possibility of three-dimensional reconstruction of the heart chambers - the left and / or right ventricle based on magnetic resonance imaging, computed tomography. The obtained models are used for numerical modeling of hemodynamic effects and assessment of the functional characteristics of the heart - ejection fraction of the left ventricle and stroke volume of the right ventricle. To do this, on the basis of reconstructions, three-dimensional grids of finite elements of computational regions are obtained - a solid body (walls of the heart chambers) and liquid (blood flow). Thus, a combined analysis of the fluid-solid-body interaction (FSI) is carried out, which allows us to evaluate both components of the heart function — the direct behavior of the heart walls from the position of the stress-strain state and the fluid hydrodynamics inside them. The methodology involves the use of complex material models for solids: single, double, or multilayer anisotropic material, for example, the Mooney-Rivlin model. Modeling of fluid behavior is carried out on the basis that the blood flow in the ventricles is laminar, Newtonian, viscous and incompressible. A key feature of the method is the possibility of a numerical assessment of hemodynamics after remodeling of the heart as a result of an intervention on the pulmonary valve — reduction and reconstruction of the anterior wall volume associated with replacement / implantation of the pulmonary valve.

The main disadvantage of this technical solution is the impossibility of modeling the results of minimally invasive interventions, in particular, transcatheter prosthetics of the heart valves - aortic and mitral. The described technique does not contain the stages of reconstruction of the elements of the aorta - the aortic root, its ascending divisions and the arch. These anatomical structures are crucial for modeling the behavior of the delivery system, the most minimally invasive transcatheter prosthesis.

An additional drawback is the lack of stages in the reconstruction of models of medical devices / products - prosthetic heart valves, systems for their implantation and, therefore, the impossibility of assessing their hemodynamics and mechanics under conditions of functioning in a pre- and implanted state.

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Partially similar drawbacks are deprived of the flow modeling technique, including reconstruction of the aortic root (US Patent No. US 8224640 B2 “Method and system for computational modeling of the aorta and heart”, publication date July 17, 2012). The technique serves to support decision-making in the treatment and prognosis of heart disease using a personalized anatomical model of the heart, created on the basis of volumetric clinical images. The work of the technique is based on the following components:

(1) end-patient-specific geometric models and corresponding blood flow velocity fields in the aorta, aortic valve, and left ventricle;

(2) non-linear, anisotropic, parametric, constitutive models for describing the mechanical properties of the aortic wall;

(3) conducting FSI modeling taking into account the specific boundary conditions of the speed and geometry of the final patient (3D-MRI, CT, and rotational x-ray image with time resolution);

(4) advanced anatomical, physiological and hemodynamic parameters obtained as a result of numerical simulation of FSI;

(5) models for the progression of cardiovascular disease to assess the risk of specific clinical conditions and outcomes.

Obtaining three-dimensional models is possible based on the analysis of data from non-invasive clinical methods: computed tomography (CT), magnetic resonance imaging (MRI) and echocardiography data. As a result of reconstruction of three-dimensional models, it is possible to obtain data on the anatomy of the left ventricle (endocardium and epicardium), the right ventricle, the left and right atria, mitral and aortic valves and the main vessels: the aorta and pulmonary trunk. The authors of the technique argue that a complete personalized modeling of the anatomy and functioning of the left ventricle, aortic valve, and aorta using advanced computational methods for the mechanics of conjugated fluid and solid body helps to make a decision in choosing the tactics of surgical correction of a disease. Risk identification allows you to determine the appropriate time for surgery, to evaluate the effectiveness of drug therapy and gives an idea of the development of new methods of treatment. Personalized models allow the measurement of morphological, dynamic and biomechanical characteristics, including: dynamics of aortic dilatation, including the fibrous ring, sinotubular connection, aortic arch, descending sections; changes in wall thickness, lumen and aortic compliance, as well as its stiffness; the size and mass of the myocardium of the heart chambers. Modeling fluid flows on specific anatomical models of the patient allows us to assess the hemodynamic parameters that characterize complex flow fields, including turbulence, as well as wall shear stress, blood flow velocity field, displacement of the walls of the heart chambers, von Mises stress (tension) and turbulence intensity (vorticity). Calculation of these indicators can be used to model disease progression and stratify the risk of intra- or post-procedural complications for individual patients.

The main disadvantage of the described technique is also the lack of stages of analysis and reconstruction of a medical device and its effects on the functioning of heart elements, as well as hemodynamics. Thus, the methodology does not involve the assessment and prediction of the risks of interventions, including the use of prosthetic heart valves, including and minimally invasive transcatheter products. At the same time, surgical prosthetics and reconstruction of the mitral and aortic valves, which are key procedures in the treatment of acquired heart defects, require the use of prostheses, rings, gangs and other designs - medical devices.

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A known technique for creating a three-dimensional model of a prosthetic heart valve designed for transcatheter implantation (EU Patent No. EP 1994482 B1 "Virtual heart valve", publication date 02/27/2013). The invention uses computational methods to create a three-dimensional geometry of a heart valve bioprosthesis. Starting with a flat sweep, a three-dimensional model of the valve is formed by simulating the valve assembly process, by folding the flats in a flat shape and attaching them to the valve frame. Virtual assembly technology allows you to accurately determine the three-dimensional geometry of the wings. This method allows developers to quickly create prototype valves with various designs of flaps and / or stents and stent-like frames, as well as perform stress-strain analysis before prototyping. The invention allows to describe the parameters of the casement material as a thin elastomeric polymer sheet characterized by non-linear hyperelastic behavior, or a thin polymer sheet approximated by a linear model. For example, the parameters of the leaf material can be biological tissues characterized by a nonlinear anisotropic model of tissue of the Fung type, which is an actual description from the standpoint of modern numerical modeling.

The disadvantage of this invention is the lack in the methodology of the biological components of the anatomy of the aortic root and the heart as a whole, as well as the delivery system for the transcatheter valve. The absence of these elements does not allow simulating all stages of implantation of a transcatheter prosthesis and the formation of the final state of the prosthesis, i.e. evaluate its effectiveness, changes in the stress-strain state, the presence of critical nodes after deformation in the area of the prosthetic heart valve.

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Closest to the claimed invention is a method for modeling virtual implantation of products for the treatment of valvular heart disease and predicting the results of their implantation (US Patent No. 7,333,643 B2 "System and method for facilitating cardiac intervention", publication date 02/19/2008). The invention discloses a computerized system and method for modeling surgical intervention. The method includes the creation of a patient-specific computerized interactive model of the heart based on the data of the final patient obtained using functional research methods. A computerized interactive model may include at least one surgical intervention to determine the optimal strategy and choice of medical device. Procedures that can be simulated include coronary artery bypass grafting, stenting, ventricular surgical repair, reconstructive procedures and / or valve prosthetics with implantation devices - annuloplasty and prosthesis rings. The method involves the collection of geometric and functional parameters of the heart and its vessels, as well as hemodynamic parameters, for numerically modeling the effects that occur before and after the final intervention in order to predict and select treatment tactics.

The disadvantage of the described solution is the inability to simulate transcatheter interventions, due to the lack of steps for creating and evaluating the behavior of delivery systems - catheters, which provide the function of introducing and implanting these devices (self-and balloon-expanding).

The technical result of the invention is to predict and reduce the risks of transcatheter interventions on the heart valves and determine the most optimal prosthetic models at the stage of preoperative planning.

The technical result of the claimed invention is achieved through the use of a numerical simulation procedure for transcatheter prosthesis of the heart valve, taking into account the anatomy of the final patient, the design and features of the prosthesis, as well as its delivery system.

The result is achieved through the use in the method (method) of the reconstruction stages of a three-dimensional model of a medical device based on graphic data of non-destructive analysis methods, as well as the reproduction of all stages of the procedure: packaging the prosthesis into the delivery system, moving the system to the target implantation site, opening the prosthesis, removing the system delivery. Such an approach will allow modeling and predicting the risks (risk stratification) of transcatheter interventions on the heart valves for the case of the final patient to determine the most optimal models of prostheses and accesses at the stage of preoperative planning.

A method for the numerical simulation of transcatheter implantation of the heart valve of the end patient is proposed, including computer modeling of the patient’s heart with the creation of an interactive model of the heart at the stage of preoperative planning, collecting and fixing the geometric and functional parameters of the heart and its vessels using numerical modeling, as well as heart hemodynamics and processing obtained results and planning stages of heart valve reconstruction.

The difference is that the reconstruction of the heart valve includes preoperative modeling of the transvascular delivery system, modeling the movement of the delivery catheter along the conductor, modeling the interaction of the delivery system and the patient’s vascular bed - the descending aorta, the aortic arch and the aortic root with the identification of the stress-strain state of the aorta, heart anomalies and vessels and prevention of the risk of vascular complications and hemodynamic effects, and numerical simulation is carried out with the construction of a graphic diagram of the stress-strain state with the identification of the probability of injury to the biological components of the heart and the risk of conduction disturbance.

The proposed method is illustrated in 16 images.

The method includes the steps of reconstructing three-dimensional volumetric models of the heart and large vessels of the end patient, mitral and aortic valves of the heart, and pathological areas such as calcification and fibrosis, which may affect the outcome of the simulation of transplant catheter valve implantation.

What is new is the presence in the proposed method of a step for obtaining and reconstructing a spatial model of a transcatheter prosthesis of a heart valve and a system of its transvascular delivery, including a catheter and a conductor.

Another difference from the known methods and techniques is the presence of the stage of modeling the implantation system to the target site - the aortic valve or mitral valve, taking into account the features of the procedure - the movement of the delivery catheter along the conductor, and the presence in the methodology of the stage of modeling the interaction of the delivery system and the patient's vascular bed - the descending aorta , an aortic arch, which determines the risk of vascular complications by evaluating the arising forces and the stress-strain state of the aorta.

The invention is illustrated by images where shown:

In FIG. 1. shows a schematic diagram of the claimed methodology, including three main stages, input and output data, as well as the sequence of their relationships.

In FIG. 2. shows one of the possible principles of reconstruction of the anatomical structures of the heart - the aorta based on computed tomography using guiding curves in the computer-aided design system (manual method). The number 1 indicates the DICOM section of the image of the end patient obtained by MSCT, the number 2 is the aortic root in the form of a reconstructed three-dimensional object, the number 3 is the aortic arch as a three-dimensional object, and the number 4 is the three-dimensional section of the descending aorta. The arrows show an example of the location of the transverse planes relative to the longitudinal section.

In FIG. 3. the same, but in the semi-automatic method - based on the x-ray density. This approach is based on well-known object contouring algorithms implemented in commercial software, for example, Amira (Thermo Fisher Scientific, USA), or Mimics (Materialize NV, Belgium). Due to the semi-automatic operation of the algorithms, it is possible to accelerate and simplify the construction of models, however, a significant drop in their accuracy and quality is possible - the presence of false holes, thinning, complex wall topography, etc., requiring manual adjustment. However, this method of obtaining three-dimensional models can also be applied in the framework of the claimed invention.

In FIG. 4. The input data for reconstruction of a model of a prosthetic valve of the heart are shown using the high-resolution computer microtomography method and a self-expanding aortic valve prosthesis (manual method). Numeral 5 denotes a three-dimensional model of the support frame obtained by the method of constructing in a computer-aided design system by the method of curves, by analogy with figure 1.

In FIG. 5. the same, but in the semi-automatic method - on the basis of X-ray density, This approach allows us to simplify and accelerate the reconstruction of the model of a medical device, however, the loss of small parts and coarsening of the geometry is possible. However, this type of reconstruction of spatial models is also possible within the framework of the present invention.

In FIG. 6. An example of a hexahedral finite element mesh constructed using the reconstructed model of the supporting frame is shown, which is necessary for applying numerical calculation algorithms based on constructing a finite element mesh - primitives (flat triangles and volumetric tetrahedrons) or their derivatives (flat quadrangles or volumetric hexahedra). The number 6 denotes the finite element grid obtained on the basis of the reconstructed three-dimensional geometry of the prosthesis.

In FIG. 7. The basic three-dimensional computer models of components for the calculation procedure are shown. Where the number 7 indicates the reconstructed model of the conductor, providing movement of the delivery system 8.

In FIG. 8. An example of material modeling is shown, which can describe the numerical behavior of the objects of study: a linear model, a polynomial model, a model of hysteresis behavior (for example, nitinol), which can be obtained by approximating experimental data. The level of deformation is determined.

In FIG. 9. An example of the mutual arrangement of three-dimensional computer models of all objects involved in the interaction in the numerical calculation of transcatheter implantation of a valve prosthesis, including anatomical objects, a delivery system, a conductor and the prosthesis itself, is shown.

In FIG. 10. The scheme of crimping and packaging the supporting frame of a self-expanding prosthesis of a heart valve into a delivery system at the stage of numerical simulation is shown. The arrows indicate the direction of radial compression of the prosthesis into the delivery system - an example of modeling the pre-implantation valve packaging.

In FIG. 11. The intermediate stage of implantation of the transcatheter valve of the heart is shown — carrying out the delivery system to the target implantation site. The bend of the delivery system due to interaction with the conductor is visible.

In FIG. 12. The stage of partial release of the valve prosthesis from the delivery system in the region of the aortic valve is visualized, in which the valve prosthesis under investigation is fixed with its distal zone in the delivery device.

In FIG. 13. An example of the output data is shown - a diagram of the voltage distribution in the model of the crimped (compressed) delivery system of the support frame, using the self-expanding nitinol stent as an example.

In FIG. 14. An example of the output of the stress-strain state, distribution diagram, in the model of the aortic root after contact with the support frame is shown as an example of mechanical indicators characterizing the injury of biological components and the risk of developing conduction disturbances (blockade of the left bundle of the bundle of Giss).

In FIG. 15. An example of an analysis of the degree of deformation of the supporting frame after modeling implantation in the position of the aortic valve for a variety of combinations of objects included in the numerical analysis is shown, in comparison with the data of intraoperative fluoroscopy of the final patient for whom preoperative modeling was performed. Where figure 9 shows an example of an intraoperative fluoroscopy card, figure 10 shows the contour of an implanted prosthetic heart valve, with which the geometry obtained as a result of preoperative planning is compared.

In FIG. 16. shows the structure and quantitative indicators of blood flow after numerical simulation (data presented for diastole). Those. the hemodynamic parameters of the heart obtained during the simulation were analyzed: heart volume, linear velocity of blood and its resistance, which is one of the important indicators in planning the stages of valve reconstruction.

The claimed methodology (figure 1) is a combination of three successive stages: reconstruction of three-dimensional models (I), numerical modeling of transcatheter implantation procedure (II) and processing of the results of modeling transcatheter prosthesis of the heart valve (III) - mitral or aortic.

The input data of the first stage of the methodology is to obtain high-precision three-dimensional computer models of objects (Fig. 2, Fig. 3, Fig. 4 and Fig. 5) involved in the prosthetics procedure - the heart, large vessels, conductor, delivery system and directly transcatheter prosthesis of the heart valve .

Thus, at stage I of the method, the patient-specific geometry of the heart and other proximal structures are determined using various methods of obtaining medical images, such as computed tomography (CT) (Fig. 2 and Fig. 3), high-resolution computer microtomography (Micro CT) (Fig. 4), magnetic resonance (MR), rotational radiography and / or ultrasound (US). Graphic data obtained by the described methods, presented by sets (sets) of clinical DICOM 1, jpeg, bmp or tiff images, are imported into well-known medical image processing systems that allow automatically, semi-automatically or manually using known technologies to reconstruct three-dimensional computer models of objects for subsequent numerical analysis .

These models include:

1) the anatomical structures of the left and right ventricles, left and right atria, excretory section of the left ventricle, aortic root 2, aortic arch 3, descending aortic section 4, chordal apparatus, aortic valve cusps, mitral valve, pathological components (calcifications);

2) models of the medical device: transcatheter prosthesis 5, presented, but not limited to the supporting frame. Perhaps the inclusion in the reconstruction of the sash apparatus, cladding;

3) models of auxiliary elements: conductor 7, delivery system of the transcatheter prosthesis 8. In addition, if necessary, reconstruction of the hemostatic port for the introduction of the delivery system and the catheter used for contrasting (pig-tail) is possible.

Three-dimensional models can be solid solid objects, flat or curved surfaces and planes, or a combination thereof.

The stage of numerical analysis (II) involves combining all the three-dimensional models obtained in stage I into a single assembly corresponding to the anatomical arrangement of all elements. The reference for the relative position of the elements during the simulation can be CT, MikroKT, MR, rotational radiography and / or ultrasound. Numerical modeling is carried out using the finite element method, the finite volume method, the finite difference method, the immersed boundary method. Thus, the method involves the possibility of a combined analysis of "liquid-solid" - FSI to determine the hemodynamic and physico-mechanical parameters of the heart. To perform numerical analysis, reconstructed three-dimensional models are decomposed using, but not limited to, three-dimensional or flat elements (6) 6 containing three, four or six faces that can approximate the corresponding geometry (for the finite element method) or the computational domain ( for the immersed border method).

On spatially located three-dimensional models (Fig. 7), boundary conditions are imposed that determine the interaction (contact), movement, loads, and restrictions on the movement of objects in accordance with the simulated procedure step. Contact interaction between objects can be described by the classical isotropic model of Coulomb friction, which determines the coefficient of friction in terms of sliding speed, contact pressure, average surface temperature at the contact point and field variables; stiffness method (fine); kinematic method or Lagrange multiplier method; custom method. As the boundary conditions of movement, the technique involves the use of displacements in coordinates. The loads that can be applied include, but are not limited to determining the concentrated force, moment of force, pressure, load on the edge of the shell, surface traction, load on the pipe, body force, linear load, gravity, generalized plane deformation of the load, body rotation force , inertial unloading load, surface heat flux, body heat flux, concentrated heat flux. Restrictions on the movement of bodies or their elements are imposed separately for all six degrees of freedom - linear movement along the axes X, Y, Z and rotations relative to them RZ, RY, RZ. The imposition of all boundary conditions is possible for Cartesian or polar coordinate systems (cylindrical or spherical coordinates).

The behavior of all elements involved in numerical calculations must correspond to the native physical and mechanical characteristics, as a result of which it can be described linear or non-linear, isotropic or anisotropic, hyperelastic, compressible or incompressible material, as well as material with hysteretic behavior (for example, nitinol) (shown in Fig. 8). Material models can be obtained by known methods - numerical calculations based on mathematical formulas, including the theory of the strength of materials and materials science, by approximating the experimental data of uniaxial and biaxial tension, compression, torsion, tearing, friction, cyclic fatigue, SN curves and etc. The fatigue strength of the material in the event of cyclic loads, the range of permissible deformation is determined.

As part of numerical modeling, sequential reproduction of all stages of transcatheter prosthesis implantation is carried out, which affect the geometry and stress-strain state of the prosthesis itself, its delivery system and surrounding tissues. These stages include:

a) Crimping (packaging) of the prosthesis model in the delivery system 8 through the use of cylindrical membranes and / or surfaces acting radially (Fig. 10). Due to the corresponding contact interactions, the prosthesis is compressed from the initial free state to a small cylindrical diameter of 6-10 mm in accordance with the actual procedure.

b) The movement of the delivery system (Fig. 9, 11), in which the prosthesis of valve 5 is packed, along the conductor 7 to the target implantation site, due to which deformations of the heart valve prosthesis itself and its components are simulated as accurately as possible. This approach is necessary to assess the accumulation of all deformations during the movement / bending of the delivery system, which can contribute to the final implanted state. In addition, the stage involves the interaction of the delivery system with the surrounding tissues - the descending aorta, the arch and the root, from the position of the forces and deformations that arise, and, therefore, predicting the risk of vascular complications and trauma to the inner surface of the vessel.

c) The release of the transcatheter prosthesis 5 from the delivery system 8 upon reaching the target site of implantation - the aortic valve or mitral valve (Fig. 12). This stage involves contact interaction of all elements of the simulated system, the reconstruction of which was carried out: anatomical structures, prosthesis, delivery system, conductor - depending on the necessary modeling goal and the strength of the prognostic model for preoperative planning of the intervention.

One or more stages can be added to the staged nature of the claimed methodology, the need of which (s) may affect the prognostic value of the results. However, the above sequence (a-c) cannot be shortened and is minimally sufficient for the validity of the method (method).

The final stage (III) (an example is shown in Fig. 13, Fig. 14, Fig. 15 and Fig. 16) of the claimed method consists in processing the results obtained by numerical simulation from the standpoint of strength, mechanical and hemodynamic analysis. As a result of the simulation, all bodies and their components involved in each stage (a-c) of stage II can be analyzed qualitatively and quantitatively with the following indicators:

- mechanical characteristics arising as internal and external forces of bodies: stress components (normal and shear), integrated stress estimates (Mises and Tresca), pressure stress, strain (normal and shear), plastic and elastic strains.

- characteristics of contact interaction: contact pressure, voltage, force, displacement, normalized contact force per unit contact line.

- characteristics of fatigue (multi-cycle) strength and failure of elements: the number of cycles before the initial fracture of the material, stiffness degradation indicators, variable and average stresses for analysis by the Goodman method, strength coefficient.

- energy characteristics of the objects of study and their components: energy dissipated by creep, swelling and viscoelasticity; energy dissipated as a result of damage; kinetic energy density; energy density of elastic deformation; plastic strain rate energy;

- hydrodynamic characteristics: shear stress of the fluid current, wall stress, Reynolds stress, frequency and cyclic characteristics, pressures, velocity fields along the main axes, distribution characteristics of two-component liquids (for example, blood).

- the obtained direct data from a numerical study are converted into accepted clinical indicators, including but not limited to the ejection fraction; volumetric indicators of the heart chambers; shock volume index; cardiac output; pressure in the pulmonary artery (if any); aortic root; average, maximum and minimum blood pressure.

The analysis allows stratification of the risk of transcatheter implantation of the aortic valve or mitral valve prosthesis at the planning stage of the operation, including characterization of the risk of intra- or post-procedural complications for individual end patients, based on quantitative and qualitative data of numerical analysis. Risk stratification into two subgroups - low and high, is carried out separately for each type of complications associated with transcatheter valve prosthetics - para-prosthetic regurgitation, conduction disturbances, dislocation, vascular complications, etc. based on morphology, dynamics, hemodynamics.

In case of unsatisfactory results, it is possible to re-simulate using a different size or model of the prosthesis with subsequent stratification of the risk of complications. A comparative analysis of two or more calculations allows you to choose the optimal and safe treatment tactics - transcatheter prosthetics, prosthesis model, size, access and other variable input procedures.

All the features of the claims of the claimed invention: preoperative modeling of the transvascular delivery system, modeling the movement of the delivery catheter along the conductor, modeling the interaction of the delivery system and the vascular bed of the patient - the descending aorta, revealing the stress-strain state of the aorta, cardiac and vascular anomalies and preventing the risk of vascular complications and hemodynamic effects , numerical modeling carried out with the construction of a graphic diagram of the stress-strain state with the identification of the probability of injury to the biological components of the heart and the risk of conduction disturbance can reduce the risks of transcatheter interventions on the heart valves and determine the most optimal prosthetic models, which allows to achieve the claimed technical result. The features of the claims are essential.

The inventive step of the claimed technical solution consists in the optimal combination of three successive stages: reconstruction of three-dimensional models, numerical simulation of transcatheter implantation procedures and processing of the results of transcatheter prosthesis of the heart valve, mitral or aortic, at the stage of preoperative planning by modeling possible risks and accurate mathematical calculation, allowing to simulate a new more optimal situation, i.e. minimize all risks at the preoperative stage. Using the hemodynamic parameters of the patient and the physical data of his cardiovascular system, calculate the necessary parameters and the path of the delivery catheter and parameters of the positioning valve, calculate and simulate the valve, take into account its fatigue strength, and therefore improve treatment indicators.

Claims (1)

A method for planning transcatheter implantation of a patient’s heart valve including computer modeling of the patient’s heart with the creation of an interactive heart model at the stage of preoperative planning of the operation, collecting and fixing the geometric and functional parameters of the patient’s heart and blood vessels, as well as cardiac hemodynamics and processing the results and planning the valve reconstruction stages heart, characterized in that they perform a preoperative selection of the transvascular delivery system, namely, determine the physicomechanical, fatigue and strength properties of its individual components, simulate the movement of the delivery catheter along the conductor, analyze the interaction of the delivery system and the patient’s vascular bed - the descending aorta -deformed state of the aorta, abnormalities of the heart and blood vessels, and the identification and prevention of the risk of vascular complications and hemodynamic effects, and at the final stage, gra physical diagram of the stress-strain state with the identification of the probability of injury to the biological components of the heart and the risk of conduction disturbance.

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