Guidewire flexibility detection method, electronic device and storage medium

Abstract

The present invention provides a guidewire flexibility detection method, comprising: obtaining material distribution data of the guidewire to be detected, and obtaining dynamic simulation data of the guidewire to be detected when passing through a blood vessel simulation model under multiple fixed loads, each fixed load corresponds to a dynamic simulation data; performing finite element analysis on the guidewire to be detected according to the material distribution data, determining first flexibility data of the guidewire to be detected under multiple fixed loads, each fixed load corresponds to a first flexibility data; determining second flexibility data of the guidewire to be detected under different fixed loads according to the dynamic simulation data, each fixed load corresponds to a second flexibility data; based on the multiple first flexibility data and the multiple second flexibility data, determining the flexibility detection result of the guidewire to be detected. The present invention can improve the accuracy and reliability of flexibility evaluation.

Description

Technical Field

[0001] The present invention relates to the technical field of medical guidewires, and in particular to a guidewire flexibility detection method, an electronic device and a storage medium. Background Art

[0002] In the field of medical devices, guidewires are key tools for interventional treatments, and their flexibility (compliance) performance is directly related to the success rate of surgery and the safety of patients. The flexibility of guidewires not only affects their ability to pass through blood vessels, but is also directly related to the accuracy of the operation and the degree of damage to the blood vessel wall. Therefore, accurate evaluation of the flexibility of guidewires is crucial to ensuring medical quality and patient safety. The guidewire is compressed by a clamp, and the force and displacement changes required for the bending of the guidewire tip are manually observed and recorded to evaluate its flexibility. Although this method is intuitive, it is difficult to fully reflect the overall flexibility of the guidewire, and has poor accuracy and low reliability. Summary of the invention

[0003] The embodiment of the present invention provides a guidewire flexibility detection method, aiming to provide a solution that can improve the accuracy and reliability of guidewire flexibility detection. The guidewire is analyzed using finite element analysis to obtain first flexibility data; at the same time, second flexibility data is obtained through experimental testing, and the guidewire flexibility detection result is determined by comparing the first flexibility data and the second flexibility data. Through mutual verification, the accuracy and reliability of flexibility evaluation are improved.

[0004] In a first aspect, an embodiment of the present invention provides a guidewire flexibility detection method, the method comprising the following steps:

[0005] Acquire material distribution data of the guidewire to be tested, and acquire dynamic simulation data of the guidewire to be tested when passing through a blood vessel simulation model under the action of multiple fixed loads, each of the fixed loads corresponding to one dynamic simulation data;

[0006] Performing finite element analysis on the guidewire to be detected according to the material distribution data, and determining first flexibility data of the guidewire to be detected under a plurality of fixed loads, each of the fixed loads corresponding to one piece of the first flexibility data;

[0007] Determine, according to the dynamic simulation data, second flexibility data of the guidewire to be detected under the action of different fixed loads, each fixed load corresponds to one piece of the second flexibility data;

[0008] Based on the plurality of first flexibility data and the plurality of second flexibility data, a flexibility detection result of the guide wire to be detected is determined.

[0009] Optionally, the step of performing finite element analysis on the guidewire to be detected according to the material distribution data to determine first compliance data of the guidewire to be detected under a plurality of fixed loads respectively comprises:

[0010] Constructing a geometric model of the guidewire to be tested, wherein the geometric model includes a guidewire core model, a guide head model, and a hose model;

[0011] According to the material distribution data, a finite element analysis of the static structure of the geometric model is performed to obtain the first flexibility data of the guide wire to be tested in a theoretical state.

[0012] Optionally, the material distribution data includes guide wire core material distribution data, guide head material distribution data and hose material distribution data, and the step of performing a static structure finite element analysis on the geometric model according to the material distribution data to obtain first flexibility data of the guide wire to be tested in a theoretical state includes:

[0013] Meshing the geometric model to obtain a mesh model of the guidewire to be detected, wherein the mesh model includes a guidewire core mesh model, a guide head mesh model, and a hose mesh model;

[0014] Filling cells in the guide wire core grid model based on the guide wire core material distribution data to obtain a first material grid model;

[0015] Filling cells in the guide head grid model based on the guide head material distribution data to obtain a second material grid model;

[0016] Filling cells in the hose grid model based on the hose material distribution data to obtain a third material grid model;

[0017] The first material grid model, the second material grid model, and the third material grid model form a model to be analyzed;

[0018] Performing finite element analysis on the model to be analyzed by loading a plurality of the fixed loads respectively, to obtain a plurality of groups of finite element analysis results, each group of the finite element analysis results corresponding to one of the fixed loads;

[0019] Based on multiple groups of the finite element analysis results, multiple first flexibility data of the guide wire to be tested in a theoretical state are determined, and each of the finite element analysis results corresponds to one first flexibility data.

[0020] Optionally, the finite element analysis result includes displacement data and stress data of each cell, and the step of determining a plurality of the first flexibility data of the guide wire to be tested in a theoretical state based on the plurality of groups of the finite element analysis results includes:

[0021] Determining a flexibility matrix corresponding to the finite element analysis result through the displacement data and the stress data;

[0022] Based on the flexibility matrices corresponding to the multiple finite element analysis results, a plurality of the first flexibility data of the guide wire to be tested in a theoretical state are determined.

[0023] Optionally, a curved path is provided in the blood vessel simulation model, the guide wire to be detected passes through the curved path under the action of a fixed load, and the guide wire to be detected passes through the curved path under the action of multiple fixed loads, and the step of determining the second flexibility data of the guide wire to be detected under the action of different fixed loads according to the dynamic simulation data includes:

[0024] For each of the fixed loads, the bending amount sequence and the jitter amount sequence of the guidewire to be detected when passing through each target path segment are determined through the dynamic simulation data, wherein the target path segment is a segment of the curved path that contains a lesion;

[0025] According to the bending amount sequence and the jitter amount sequence, the second flexibility data of the guide wire to be tested under each of the fixed loads is determined.

[0026] Optionally, the bending amount sequence includes the curvature distribution and bending angle distribution of the guide wire to be detected in the target path segment, and the jitter amount sequence includes the axial offset distribution of the guide wire to be detected in the target path segment, and the axial offset is the offset between the central axis of the guide wire to be detected and the central axis of the target path segment.

[0027] Optionally, the step of determining the second flexibility data of the guide wire to be tested under each of the fixed loads according to the bending amount sequence and the jitter amount sequence includes:

[0028] Based on the curvature distribution and the bending angle distribution, a first normalization process is performed using a fixed curvature and a fixed bending angle of the target path segment to obtain a bending amount factor BF;

[0029] Based on the axis offset distribution, a second normalization process is performed using an average diameter of the target path segment to obtain a jitter factor VF;

[0030] Based on the bending amount factor BF and the jitter amount factor VF, the second flexibility data of the guide wire to be tested under each fixed load is determined.

[0031] Optionally, the step of determining the flexibility detection result of the guidewire to be detected based on the plurality of the first flexibility data and the plurality of the second flexibility data includes:

[0032] Calculating the correlation between the first compliance data and the second compliance data under the same fixed load to obtain correlation values ​​under each fixed load;

[0033] Calculating the average correlation value under all the fixed loads;

[0034] If the average correlation value is less than a preset correlation threshold, determining that the flexibility test result of the guidewire to be tested is failed;

[0035] If the average correlation value is greater than or equal to a preset correlation threshold, it is determined that the flexibility test result of the guidewire to be tested is passed.

[0036] In a second aspect, an embodiment of the present invention further provides an electronic device,

[0037] The method comprises: a memory, a processor and a computer program stored in the memory and executable on the processor, wherein when the processor executes the computer program, the steps in the guidewire flexibility detection method as described in any one of the embodiments of the present invention are implemented.

[0038] In a third aspect, an embodiment of the present invention provides a computer-readable storage medium having a computer program stored thereon, and when the computer program is executed by a processor, the steps of the guidewire flexibility detection method provided in the embodiment of the invention are implemented.

[0039] In an embodiment of the present invention, material distribution data of the guidewire to be detected is obtained, and dynamic simulation data of the guidewire to be detected when passing through a blood vessel simulation model under the action of multiple fixed loads is obtained, and each fixed load corresponds to a dynamic simulation data; finite element analysis is performed on the guidewire to be detected based on the material distribution data to determine the first flexibility data of the guidewire to be detected under the action of multiple fixed loads, and each fixed load corresponds to a first flexibility data; based on the dynamic simulation data, the second flexibility data of the guidewire to be detected under different fixed loads is determined, and each fixed load corresponds to a second flexibility data; based on the multiple first flexibility data and the multiple second flexibility data, the flexibility detection result of the guidewire to be detected is determined. The present invention uses finite element analysis to analyze the guidewire to obtain the first flexibility data; at the same time, the second flexibility data is obtained through experimental testing, and the guidewire flexibility detection result is determined by comparing the first flexibility data and the second flexibility data, and the accuracy and reliability of the flexibility evaluation are improved through mutual verification. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0041] Figure 1 is a flow chart of a guidewire flexibility detection method provided by an embodiment of the present invention;

[0042] Figure 2 It is a structural schematic diagram of an electronic device provided by an embodiment of the present invention. DETAILED DESCRIPTION

[0043] The technical scheme in the embodiment of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiment of the present invention. Obviously, the described embodiment is only a part of the embodiment of the present invention, not all of the embodiments. Based on the embodiment of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0044] like Figure 1 As shown, Figure 1 : is a method flow chart of a guide wire flexibility detection method provided by an embodiment of the present invention. The guide wire flexibility detection method comprises the steps of:

[0045] 101. Obtain material distribution data of a guidewire to be tested, and obtain dynamic simulation data of the guidewire to be tested when passing through a blood vessel simulation model under the action of multiple fixed loads, wherein each fixed load corresponds to one dynamic simulation data;

[0046] 102. Perform finite element analysis on the guidewire to be detected according to the material distribution data to determine first flexibility data of the guidewire to be detected under a plurality of fixed loads, respectively, where each fixed load corresponds to one piece of the first flexibility data;

[0047] 103. Determine, according to the dynamic simulation data, second flexibility data of the guidewire to be tested under different fixed loads, wherein each fixed load corresponds to one piece of second flexibility data;

[0048] 104. Determine a flexibility detection result of the guidewire to be detected based on the plurality of first flexibility data and the plurality of second flexibility data.

[0049] In the embodiments of the present invention, in the field of medical devices, the flexibility of the guidewire is crucial to the success rate of the operation and the safety of the patient. Flexibility not only affects the passability of the guidewire in the blood vessel, but is also directly related to the accuracy of the operation and the degree of damage to the blood vessel wall. The degree to which a material bends or deforms when subjected to force. For a guidewire, flexibility is an important property that enables it to pass smoothly through a curved blood vessel without causing damage.

[0050] In this embodiment, the material distribution data can be obtained through material testing or data provided by the manufacturer, and the material distribution data is used to construct a geometric model of the guidewire and perform finite element analysis. The material distribution data may include one or more physical and chemical indicators, such as density, elastic modulus, Poisson's ratio, composition gradient, elastic modulus gradient, hydrophilic coating material composition and hydrophilic coating material thickness, etc.

[0051] It should be noted that, under the condition of batch testing of the same batch of guide wires, the above material distribution data is reusable data, that is, there is no need to obtain the material distribution data of each guide wire separately, and it only needs to be obtained once.

[0052] In this embodiment, the blood vessel simulation model is a physical model, and a curved path of a simulated blood vessel is provided in the blood vessel simulation model. The guide wire to be detected travels along the curved path, and during the travel, the guide wire to be detected will bend along the curved path. Specifically, the guide wire to be detected is inserted into the entrance of the blood vessel simulation model, and a fixed load is applied to push the guide wire to be detected along the curved path of the simulated blood vessel. This embodiment has no particular restrictions on the specific structure of the blood vessel simulation model. For example, the blood vessel simulation model is a proportional and geometrically scaled model of the actual blood vessel, and the blood vessel simulation model may also only include the core features of the actual blood vessel.

[0053] Exemplarily, the blood vessel simulation model is a transparent entity model, and the above-mentioned dynamic simulation data can be image data obtained by image capture or laser scanning data obtained by laser scanning. During the movement of the guidewire to be detected, a continuous clear image of the guidewire to be detected traveling along a curved path in the blood vessel simulation model can be captured by a CMOS sensor. Through image recognition and image segmentation algorithms, the motion data of the guidewire to be detected is extracted from the continuous clear image to obtain the dynamic simulation data of the guidewire to be detected. In addition, during the movement of the guidewire to be detected, a three-dimensional laser scanner can also be used to align the blood vessel simulation model to ensure that the scanning range covers the entire movement of the guidewire. Considering the interaction between the laser beam and the surface of the guidewire to be detected, it is ensured that the scanning data can accurately reflect the shape and position of the guidewire to be detected. Laser scanning is performed in real time to obtain point cloud data of the surface of the guidewire to be detected. The point cloud data is preprocessed by denoising, registration, segmentation and other preprocessing operations to obtain the dynamic simulation data of the guidewire to be detected.

[0054] In this embodiment, a static structural finite element analysis is performed on the geometric model of the guidewire to be tested according to the material distribution data, and the deformation of the guidewire under multiple fixed loads is analyzed to obtain the first flexibility data. The dynamic simulation data is processed to determine the actual bending and shaking of the guidewire to be tested under different fixed loads to obtain the second flexibility data.

[0055] If the first flexibility data is similar to the second flexibility data, it can be determined that the flexibility test result of the guide wire to be tested is passed; if the first flexibility data is significantly different from the second flexibility data, it can be determined that the flexibility test result of the guide wire to be tested is failed.

[0056] In a possible embodiment, a classifier may be trained, the first flexibility data and the second flexibility data may be input into the classifier, and the classifier may be used to determine whether the flexibility test result of the guidewire to be tested is passed or failed. The classifier may be a support vector machine or a deep learning model.

[0057] In this embodiment, finite element analysis is used to analyze the guide wire to be tested to obtain first flexibility data; at the same time, second flexibility data is obtained through experimental testing, and the guide wire flexibility detection result is determined by comparing the first flexibility data and the second flexibility data. Through mutual verification, the accuracy and reliability of the flexibility evaluation are improved.

[0058] Optionally, the step of performing finite element analysis on the guidewire to be detected according to the material distribution data to determine first compliance data of the guidewire to be detected under a plurality of fixed loads respectively includes:

[0059] Constructing a geometric model of the guidewire to be tested, wherein the geometric model includes a guidewire core model, a guide head model, and a hose model;

[0060] According to the material distribution data, a finite element analysis of the static structure of the geometric model is performed to obtain the first flexibility data of the guide wire to be tested in a theoretical state.

[0061] In an embodiment of the present invention, a geometric model of the guidewire to be detected can be constructed according to the shape and structural parameters of the guidewire to be detected. The geometric model is a three-dimensional reproduction representation of the guidewire to be detected in a computer, which can accurately replicate the actual structure and shape of the guidewire to be detected. Since the guidewire mainly includes a guidewire core, a guide head, and a hose outside the guidewire core, the obtained geometric model includes three main parts: a guidewire core model, a guide head model, and a hose model. The guidewire core model, the guide head model, and the hose model together constitute the main structure of the guidewire to be detected.

[0062] It should be noted that the geometric model of the guidewire to be tested can also be reused, that is, for the same batch of guidewires with the same shape and structural parameters, only one geometric model needs to be constructed. In other words, when the fixed load remains unchanged, the first flexibility data corresponding to multiple fixed loads of multiple guidewires to be tested with the same shape and structural parameters and the same material distribution data are the same. Therefore, the first flexibility data can be reused, and there is no need to construct a model for each guidewire to be tested.

[0063] The obtained material distribution data is used to perform finite element analysis of the static structure of the geometric model. The material distribution data may include one or more physical and chemical indicators, such as density, elastic modulus, Poisson's ratio, composition gradient, elastic modulus gradient, hydrophilic coating material composition and hydrophilic coating material thickness. Material distribution data is the basis of finite element analysis, so that the theoretical response of the guidewire under stress can be accurately simulated during the finite element analysis process.

[0064] During the finite element analysis process, the geometric model can be divided into many small, interconnected elements (also called voxels). Each element will be mechanically analyzed according to the physical properties in the material distribution data. By calculating the deformation of these elements under multiple fixed loads, the first flexibility data of the guidewire to be tested under the theoretical state can be obtained. The first flexibility data reflects the degree of bending or deformation of the guidewire when subjected to force, and is an important indicator for evaluating the flexibility performance of the guidewire.

[0065] By constructing a geometric model and performing finite element analysis using material distribution data, the first compliance data of the guide wire to be tested under multiple fixed loads can be accurately determined.

[0066] The boundary constraints of the above finite element analysis can be obtained based on the blood vessel simulation model, that is, the maximum boundary parameter and the minimum boundary parameter are the maximum boundary parameter and the minimum boundary parameter in the blood vessel simulation model, which can provide a reference analysis environment for finite element analysis. The above boundary parameters include shape boundary parameters and mechanical boundary parameters.

[0067] Optionally, the material distribution data includes guide wire core material distribution data, guide head material distribution data and hose material distribution data, and the step of performing a static structure finite element analysis on the geometric model according to the material distribution data to obtain first flexibility data of the guide wire to be tested in a theoretical state includes:

[0068] Meshing the geometric model to obtain a mesh model of the guidewire to be detected, wherein the mesh model includes a guidewire core mesh model, a guide head mesh model, and a hose mesh model;

[0069] Filling cells in the guide wire core grid model based on the guide wire core material distribution data to obtain a first material grid model;

[0070] Filling cells in the guide head grid model based on the guide head material distribution data to obtain a second material grid model;

[0071] Filling cells in the hose grid model based on the hose material distribution data to obtain a third material grid model;

[0072] The first material grid model, the second material grid model, and the third material grid model form a model to be analyzed;

[0073] Performing finite element analysis on the model to be analyzed by loading a plurality of the fixed loads respectively, to obtain a plurality of groups of finite element analysis results, wherein each group of finite element analysis results corresponds to one of the fixed loads;

[0074] Based on multiple groups of the finite element analysis results, multiple first flexibility data of the guide wire to be tested in a theoretical state are determined, and each of the finite element analysis results corresponds to one first flexibility data.

[0075] In this embodiment, the constructed geometric model is meshed and divided into many small, interconnected cells, thereby obtaining a mesh model of the guidewire to be detected. The mesh model includes a guidewire core mesh model, a guide head mesh model, and a hose mesh model, which correspond to different components of the guidewire.

[0076] In a possible embodiment, meshing of the constructed geometric model can be performed by finite element analysis software to achieve automatic meshing. The finite element analysis software can be existing software such as ANSYS, Abaqus, COMSOL Multiphysics, etc., and this embodiment does not limit this.

[0077] The cells in the guide wire core grid model are filled according to the guide wire core material distribution data, so that each cell contains the correct physical properties of the guide wire core material, thereby obtaining a first material grid model. Similarly, according to the guide head material distribution data and the hose material distribution data, the cells in the guide head grid model and the hose grid model are filled respectively to obtain a second material grid model and a third material grid model.

[0078] The first material mesh model, the second material mesh model and the third material mesh model form a model to be analyzed, thereby integrating different components of the guide wire and their material properties to form a model that can be used for finite element analysis.

[0079] In a possible embodiment, in the finite element analysis software, finite element analysis is performed on the model to be analyzed by loading multiple fixed loads. The finite element analysis software is used to simulate various load conditions that the guide wire may be subjected to during actual use. For each fixed load, a set of finite element analysis results will be obtained, which reflects the deformation and stress of the guide wire under the load. The finite element analysis software can use the above-mentioned software, which will not be described in detail.

[0080] In a possible embodiment, the fixed load is a load applied by a user collected during an interventional surgery operation, so that the finite element analysis result can be closer to the interventional surgery operation scene.

[0081] Based on multiple sets of finite element analysis results, multiple first flexibility data of the guidewire to be tested under the theoretical state are determined. Each finite element analysis result corresponds to a first flexibility data, and the first flexibility data quantifies the flexibility performance of the guidewire under the load. The first flexibility data provides comprehensive and accurate information about the flexibility performance of the guidewire. In addition to being used for the detection of the flexibility performance of the guidewire, it can also be used to guide the design and manufacturing process of the guidewire.

[0082] Optionally, the finite element analysis result includes displacement data and stress data of each cell, and the step of determining a plurality of the first flexibility data of the guide wire to be tested in a theoretical state based on a plurality of groups of the finite element analysis results includes:

[0083] Determining a flexibility matrix corresponding to the finite element analysis result through the displacement data and the stress data;

[0084] Based on the flexibility matrices corresponding to the multiple finite element analysis results, a plurality of the first flexibility data of the guide wire to be tested in a theoretical state are determined.

[0085] In this embodiment, for each finite element analysis result, the displacement data and stress data therein are used to calculate the flexibility matrix corresponding to the finite element analysis result. The flexibility matrix describes the relationship between the displacement and stress generated when the guide wire is subjected to an external force. By calculating the flexibility matrix, the flexibility performance of the guide wire under different loads can be more accurately understood.

[0086] Specifically, the finite element analysis software can be used to automatically output the stiffness matrix of the model to be analyzed based on the displacement data and stress data of each cell. Generally speaking, the flexibility matrix is ​​the inverse matrix of the stiffness matrix, and the inverse matrix of the stiffness matrix, that is, the flexibility matrix, can be obtained by Gaussian elimination, LU decomposition, Cholesky decomposition, etc.

[0087] Furthermore, in order to make the flexibility matrix more accurate, the flexibility matrix is ​​calculated by the following formula (1):

[0088]

[0089] Where G is the flexibility matrix, Φ is the vibration mode matrix of the stiffness matrix, Φ T is the transpose of the vibration mode matrix of the stiffness matrix, Λ is a diagonal matrix, and its diagonal elements are Λ -1 is the inverse matrix of the diagonal matrix, ω i is the i-th modal frequency of the stiffness matrix, φ i is the stiffness value of the ith element in the stiffness matrix, is the transpose of the stiffness value of the ith element after the transpose of the stiffness matrix, and n is the number of stiffness values ​​in the stiffness matrix.

[0090] Based on the compliance matrices corresponding to the multiple finite element analysis results, multiple first compliance data of the guidewire to be tested in the theoretical state are determined. In this step, each compliance matrix can be combined with the corresponding load condition, and the first compliance data of the guidewire under the load can be calculated by a specific algorithm or formula. These data can reflect the compliance performance of the guidewire in the theoretical state, that is, without the influence of actual use wear and aging.

[0091] The flexibility matrix G has been obtained through finite element analysis, and the flexibility matrix G is an n×n matrix, where n is the number of nodes on the guide wire. The overall flexibility of the guide wire along the axial direction of the guide wire is considered.

[0092] The first flexibility Flex1 is defined as the weighted sum of the flexibility components of all nodes on the guidewire along the axial direction of the guidewire, while considering the length L of the guidewire. The flexibility component of each node can be represented by the corresponding element of the flexibility matrix G. The specific formula (2) is as follows:

[0093]

[0094] Among them, g ij is the element in the i-th row and j-th column of the flexibility matrix G, representing the flexibility component of the node ij under the action of a fixed load. ij is the weight factor of the node ij, which is used to consider the contribution of the flexibility components of different nodes to the overall flexibility. These weight factors can be set according to the position of the node on the guidewire. The closer the position on the guidewire is, the larger the weight factor is, and the farther the position on the guidewire is, the smaller the weight factor is. L is the length of the guidewire, which is used to consider the influence of the guidewire size on the flexibility. pij is the length index value of the guide wire corresponding to the node ij. ij is the local impact factor. Different nodes correspond to different local impact factors. q is the global impact factor, which is a fixed value. L pij It is used to adjust the contribution of the corresponding flexibility components of different nodes, and 1 / q is used to adjust the overall flexibility.ij and q can be selected and adjusted based on experience.

[0095] By using the displacement data and stress data in the finite element analysis results, the flexibility matrix was calculated, and multiple first flexibility data of the guidewire to be tested in the theoretical state were determined based on multiple flexibility matrices. In addition to being used for the detection of guidewire flexibility performance, the first flexibility data provides strong theoretical support for the design and manufacture of guidewires, helps to optimize the structure and performance of guidewires, and improves their flexibility and stability in actual use.

[0096] Optionally, a curved path is provided in the blood vessel simulation model, and the guidewire to be detected passes through the curved path under the action of multiple fixed loads respectively. The step of determining the second flexibility data of the guidewire to be detected under the action of different fixed loads respectively according to the dynamic simulation data comprises:

[0097] For each of the fixed loads, the bending amount sequence and the jitter amount sequence of the guidewire to be detected when passing through a target path segment are determined through the dynamic simulation data, wherein the target path segment is a lesion simulation path in the curved path;

[0098] According to the bending amount sequence and the jitter amount sequence, the second flexibility data of the guide wire to be tested under each of the fixed loads is determined.

[0099] In this embodiment, considering that the guidewire needs to pass through a complex vascular path during actual use, especially a vascular path containing a lesion, this embodiment uses a vascular simulation model to simulate this actual use environment, and sets a curved path therein to test the performance of the guidewire, that is, a curved path containing a lesion is set in the vascular simulation model, and the curved path containing the lesion is a physical model path of the vascular path containing the lesion.

[0100] For each fixed load, dynamic simulation data is used to represent the deformation response of the guidewire to be tested when it passes through a target path segment in a curved path. The target path segment can be a curved path segment containing a lesion in the curved path, so as to more realistically reflect the conditions that the guidewire may encounter in actual use.

[0101] The bending amount sequence and the jitter amount sequence of the guide wire to be detected when passing through the target path segment can be recorded or identified. The bending amount sequence reflects the bending degree of the guide wire when passing through the curved path, while the jitter amount sequence reflects the stability of the guide wire during the bending process.

[0102] The second flexibility data of the guidewire to be tested under each fixed load is determined based on the recorded bending amount sequence and jitter amount sequence, which can comprehensively consider the bending performance and stability of the guidewire and more comprehensively evaluate the flexibility performance of the guidewire when passing through complex vascular pathways.

[0103] By utilizing the curved path and dynamic simulation data in the blood vessel simulation model, the second flexibility data of the guidewire to be tested under different fixed loads can be accurately determined, thereby improving the accuracy of flexibility detection.

[0104] Optionally, the bending amount sequence includes the curvature distribution and bending angle distribution of the guide wire to be detected in the target path segment, and the jitter amount sequence includes the axial offset distribution of the guide wire to be detected in the target path segment, and the axial offset is the offset between the central axis of the guide wire to be detected and the central axis of the target path segment.

[0105] In the embodiment of the present invention, the bending amount sequence contains two important distribution information: curvature distribution and bending angle distribution. The curvature distribution describes the change in the degree of curvature of the guide wire to be detected on the target path segment, that is, the curvature of the guide wire to be detected at different positions. The bending angle distribution further describes the angle change of the guide wire to be detected during the bending process.

[0106] The jitter sequence mainly describes the distribution of the axis offset of the guidewire to be tested on the target path segment. The axis offset refers to the degree of offset between the central axis of the guidewire to be tested and the central axis of the target path segment. This parameter reflects the deviation of the axis of the guidewire from the ideal path during transmission or movement. The distribution of the axis offset can further evaluate the stability and transmission accuracy of the guidewire.

[0107] The bending amount sequence and the jitter amount sequence together provide detailed deformation characteristic information of the guidewire to be tested on each target path segment.

[0108] Optionally, the step of determining the second flexibility data of the guide wire to be tested under each of the fixed loads according to the bending amount sequence and the jitter amount sequence includes:

[0109] Based on the curvature distribution and the bending angle distribution, a first normalization process is performed using a fixed curvature and a fixed bending angle of the target path segment to obtain a bending amount factor BF;

[0110] Based on the axis offset distribution, a second normalization process is performed using an average diameter of the target path segment to obtain a jitter factor VF;

[0111] Based on the bending amount factor BF and the jitter amount factor VF, the second flexibility data of the guide wire to be tested under each fixed load is determined.

[0112] In this embodiment, the first normalization process can be performed based on the curvature distribution and bending angle distribution of the guidewire to be detected on the target path segment, using the fixed curvature and fixed bending angle of the corresponding target path segment. The bending deformation characteristics on different target path segments are standardized for better comparison and evaluation. Through the first normalization process, a bending amount factor BF can be obtained, which reflects the relative size of the guidewire to be detected in terms of bending deformation. The above-mentioned first normalization process can be divided by the curvature value in the curvature distribution by the fixed curvature at the corresponding position to obtain the curvature ratio. The curvature ratio is generally distributed near 1. The closer it is to 1, the more adapted the guidewire to be detected is to the target path segment, and the farther it is from 1, the more adapted the guidewire to be detected is to the target path segment and the less adapted the guidewire to be detected is to the target path segment. The bending angle value in the bending angle distribution is divided by the fixed bending angle at the corresponding position to obtain the bending angle ratio. The bending angle ratio is generally distributed near 1. The closer it is to 1, the more adapted the guide wire to be tested is to the target path segment, and the farther it is from 1, the more adapted the guide wire to be tested is to the target path segment and the less adapted the guide wire to be tested is to the target path segment.

[0113] Based on the distribution of the axis offset of the guidewire to be detected on each target path segment, the average diameter of the target path segment is used for the second normalization process. The axis offset parameter is also standardized so that it can be comprehensively considered with the bending factor BF. Through the second normalization process, a jitter factor VF can be obtained, which reflects the relative size of the axis offset deformation of the guidewire to be detected. The axis offset value in the axis offset distribution is calculated to be proportional to the average diameter of the target path segment to obtain the offset ratio. The larger the offset ratio, the more unstable the flexibility of the guidewire to be detected, and the easier it is to hit the blood vessel wall.

[0114] Based on the bending factor BF and the jitter factor VF, the second flexibility data of the guidewire to be tested under each fixed load can be determined. The characteristics of bending deformation and axis offset deformation are comprehensively considered to evaluate the flexibility performance of the guidewire to be tested under a specific load. Generally speaking, the flexibility test result requires a higher bending factor BF and a lower jitter factor VF.

[0115] Optionally, the step of determining the flexibility detection result of the guidewire to be detected based on the plurality of the first flexibility data and the plurality of the second flexibility data includes:

[0116] Calculating the correlation between the first compliance data and the second compliance data under the same fixed load to obtain correlation values ​​under each fixed load;

[0117] Calculating the average correlation value under all the fixed loads;

[0118] If the average correlation value is less than a preset correlation threshold, determining that the flexibility test result of the guidewire to be tested is failed;

[0119] If the average correlation value is greater than or equal to a preset correlation threshold, it is determined that the flexibility test result of the guidewire to be tested is passed.

[0120] In this embodiment, for each fixed load, the corresponding first flexibility data and second flexibility data are correlated. The consistency or similarity between the two flexibility data under the same load is evaluated through correlation, and then the correlation value under each fixed load can be obtained. The correlation value reflects the degree of association between the first flexibility data and the second flexibility data under the corresponding load. This embodiment has no particular limitation on the specific calculation method of the correlation. For example, the correlation calculation can be performed using the Pearson product-moment correlation coefficient, or using the Spearman rho coefficient, the point-biserial coefficient, the Kendall correlation coefficient, and the phi coefficient.

[0121] After calculating the correlation value under the fixed load, the average correlation value of the correlation values ​​under all the fixed loads is further calculated. The higher the average correlation value, the better the overall consistency between the first flexibility data and the second flexibility data, that is, the higher the reliability of the flexibility detection result. The average correlation value can be any type of average value, such as arithmetic mean, geometric mean, square mean (root mean square, rms), harmonic mean, weighted mean, etc.

[0122] According to the comparison result between the average correlation value and the preset correlation threshold, the flexibility test result of the guidewire to be tested can be determined. If the average correlation value is less than the correlation threshold, it means that the consistency between the first flexibility data and the second flexibility data is poor, and there may be a large error or uncertainty, so the flexibility test result of the guidewire to be tested is determined to be not passed. On the contrary, if the average correlation value is greater than or equal to the correlation threshold, it means that the consistency between the first flexibility data and the second flexibility data is good, and the test result is more reliable, so the flexibility test result of the guidewire to be tested is determined to be passed.

[0123] By comparing and analyzing the average correlation between the first flexibility data and the second flexibility data under multiple fixed loads, the flexibility performance of the guidewire to be tested is evaluated and the corresponding test results are given. The flexibility data under theoretical and actual conditions are comprehensively considered to improve the accuracy and reliability of the test results.

[0124] Figure 2 FIG. 1 is a schematic diagram of the structure of an electronic device provided by another embodiment of the present invention. Figure 2 As shown, the electronic device includes: a memory 202, a processor 201, and a computer program of a guidewire flexibility detection method stored in the memory 202 and executable on the processor 201, wherein:

[0125] The processor 201 is used to call the computer program stored in the memory 202 and execute the following steps:

[0126] Acquire material distribution data of the guidewire to be tested, and acquire dynamic simulation data of the guidewire to be tested when passing through a blood vessel simulation model under the action of multiple fixed loads, each of the fixed loads corresponding to one dynamic simulation data;

[0127] Performing finite element analysis on the guidewire to be detected according to the material distribution data, and determining first flexibility data of the guidewire to be detected under a plurality of fixed loads, each of the fixed loads corresponding to one piece of the first flexibility data;

[0128] Determine, according to the dynamic simulation data, second flexibility data of the guidewire to be detected under different fixed loads, each fixed load corresponds to one piece of the second flexibility data;

[0129] Based on the plurality of first flexibility data and the plurality of second flexibility data, a flexibility detection result of the guide wire to be detected is determined.

[0130] Optionally, the step of performing finite element analysis on the guidewire to be detected according to the material distribution data to determine first compliance data of the guidewire to be detected under a plurality of fixed loads respectively, performed by the processor 201, includes:

[0131] Constructing a geometric model of the guidewire to be tested, wherein the geometric model includes a guidewire core model, a guide head model, and a hose model;

[0132] According to the material distribution data, a finite element analysis of the static structure of the geometric model is performed to obtain the first flexibility data of the guide wire to be tested in a theoretical state.

[0133] Optionally, the material distribution data includes guide wire core material distribution data, guide head material distribution data, and hose material distribution data, and the processor 201 performs a finite element analysis of the static structure of the geometric model according to the material distribution data to obtain the first flexibility data of the guide wire to be detected in a theoretical state, including:

[0134] Meshing the geometric model to obtain a mesh model of the guidewire to be detected, wherein the mesh model includes a guidewire core mesh model, a guide head mesh model, and a hose mesh model;

[0135] Filling cells in the guide wire core grid model based on the guide wire core material distribution data to obtain a first material grid model;

[0136] Filling cells in the guide head grid model based on the guide head material distribution data to obtain a second material grid model;

[0137] Filling cells in the hose grid model based on the hose material distribution data to obtain a third material grid model;

[0138] The first material grid model, the second material grid model, and the third material grid model form a model to be analyzed;

[0139] Performing finite element analysis on the model to be analyzed by loading a plurality of the fixed loads respectively, to obtain a plurality of groups of finite element analysis results, each group of the finite element analysis results corresponding to one of the fixed loads;

[0140] Based on multiple groups of the finite element analysis results, multiple first flexibility data of the guide wire to be tested in a theoretical state are determined, and each of the finite element analysis results corresponds to one first flexibility data.

[0141] Optionally, the finite element analysis result includes displacement data and stress data of each cell, and the step of determining a plurality of the first flexibility data of the guide wire to be tested in a theoretical state based on the plurality of groups of the finite element analysis results performed by the processor 201 includes:

[0142] Determining a flexibility matrix corresponding to the finite element analysis result through the displacement data and the stress data;

[0143] Based on the flexibility matrices corresponding to the multiple finite element analysis results, a plurality of the first flexibility data of the guide wire to be tested in a theoretical state are determined.

[0144] Optionally, a curved path is provided in the blood vessel simulation model, and the guidewire to be detected passes through the curved path under the action of multiple fixed loads respectively, and the step of determining the second flexibility data of the guidewire to be detected under the action of different fixed loads respectively according to the dynamic simulation data executed by the processor 201 includes:

[0145] For each of the fixed loads, the bending amount sequence and the jitter amount sequence of the guidewire to be detected when passing through a target path segment are determined through the dynamic simulation data, wherein the target path segment is a segment of the curved path that contains a lesion;

[0146] According to the bending amount sequence and the jitter amount sequence, the second flexibility data of the guide wire to be tested under the action of each fixed load is determined.

[0147] Optionally, the bending amount sequence includes the curvature distribution and bending angle distribution of the guide wire to be detected in each of the target path segments, and the jitter amount sequence includes the axial offset distribution of the guide wire to be detected in each of the target path segments, and the axial offset is the offset between the central axis of the guide wire to be detected and the central axis of the target path segment.

[0148] Optionally, the step of determining the second flexibility data of the guide wire to be detected under the fixed load according to the bending amount sequence and the jitter amount sequence performed by the processor 201 includes:

[0149] Based on the curvature distribution and the bending angle distribution, a first normalization process is performed using a fixed curvature and a fixed bending angle of the target path segment to obtain a bending amount factor BF;

[0150] Based on the axis offset distribution, a second normalization process is performed using an average diameter of the target path segment to obtain a jitter factor VF;

[0151] Based on the bending amount factor BF and the jitter amount factor VF, the second flexibility data of the guide wire to be tested under each fixed load is determined.

[0152] Optionally, the step of determining the flexibility detection result of the guidewire to be detected based on the plurality of first flexibility data and the plurality of second flexibility data, performed by the processor 201, includes:

[0153] Calculating the correlation between the first compliance data and the second compliance data under the same fixed load to obtain the correlation value under each fixed load;

[0154] Calculating the average correlation value under all the fixed loads;

[0155] If the average correlation value is less than a preset correlation threshold, determining that the flexibility test result of the guidewire to be tested is failed;

[0156] If the average correlation value is greater than or equal to a preset correlation threshold, it is determined that the flexibility test result of the guidewire to be tested is passed.

[0157] It should be noted that the electronic device provided in this embodiment can be applied to computers, edge terminals, servers, cloud platforms and other devices that can perform guide wire flexibility detection methods, that is, the above-mentioned electronic devices can be computers, edge terminals, servers, cloud platforms and other devices.

[0158] The electronic device provided in this embodiment can implement each process implemented by the guidewire flexibility detection method in the above method embodiment and can achieve the same beneficial effect. To avoid repetition, it will not be described here.

[0159] Another embodiment of the present invention further provides a computer-readable storage medium, on which a computer program is stored. When the computer program is executed by a processor, the various processes of the guide wire flexibility detection method provided in the above embodiment of the present invention are implemented, and the same technical effect can be achieved. To avoid repetition, it will not be repeated here.

[0160] Those skilled in the art can understand that all or part of the processes in the above-mentioned embodiments can be completed by instructing the relevant hardware through a computer program. As in the above-mentioned embodiments, the processor can be hardware for performing logical operations, for example, a single-chip microcomputer, a microprocessor, a programmable logic controller (PLC, Programmable Logic Controller) or a field programmable gate array (FPGA, Field-Programmable Gate Array), or a software program, a functional module, a function, an object library (Object Libraries) or a dynamic link library (Dynamic-Link Libraries) that implements the above functions based on hardware. Or, it is a combination of the above two. The computer program can be stored in a computer-readable storage medium. When the program is executed, it can include the processes of the embodiments of the above-mentioned methods. Among them, the computer-readable storage medium can be a disk, a magnetic tape, an optical disk, a phase change memory (Phase Change Memory, PCM), a read-only storage memory (Read-Only Memory, ROM) or a random access memory (Random Access Memory, referred to as RAM), etc.

[0161] The above disclosure is only the preferred embodiment of the present invention, which certainly cannot be used to limit the scope of the present invention. Therefore, equivalent changes made according to the claims of the present invention are still within the scope of the present invention.

Claims

1. A guide wire flexibility detection method, characterized in that: The method comprises the following steps: Obtaining material distribution data of the guidewire to be detected, and obtaining dynamic simulation data of the guidewire to be detected when passing through a blood vessel simulation model under the action of multiple fixed loads, each of the fixed loads corresponding to one dynamic simulation data; a curved path is provided in the blood vessel simulation model, and the guidewire to be detected passes through the curved path under the action of multiple fixed loads; Performing finite element analysis on the guidewire to be detected according to the material distribution data, and determining first flexibility data of the guidewire to be detected under a plurality of fixed loads, each of the fixed loads corresponding to one piece of the first flexibility data; For each of the fixed loads, the bending amount sequence and the jitter amount sequence when the guidewire to be detected passes through a target path segment are determined by the dynamic simulation data, wherein the target path segment is a curved path in the curved path that contains a lesion; the bending amount sequence includes a curvature distribution and a bending angle distribution of the guidewire to be detected in the target path segment, and the jitter amount sequence includes an axial offset distribution of the guidewire to be detected in the target path segment, wherein the axial offset is an offset between a central axis of the guidewire to be detected and a central axis of the target path segment; Based on the curvature distribution and the bending angle distribution, a first normalization process is performed using a fixed curvature and a fixed bending angle of the target path segment to obtain a bending amount factor BF; Based on the axis offset distribution, a second normalization process is performed using an average diameter of the target path segment to obtain a jitter factor VF; Based on the bending amount factor BF and the jitter amount factor VF, second flexibility data of the guide wire to be detected under each of the fixed loads is determined, and each of the fixed loads corresponds to one piece of the second flexibility data; Based on the plurality of first flexibility data and the plurality of second flexibility data, a flexibility detection result of the guide wire to be detected is determined.

2. The guidewire flexibility detection method according to claim 1, characterized in that: The step of performing finite element analysis on the guidewire to be detected according to the material distribution data to determine first compliance data of the guidewire to be detected under a plurality of fixed loads comprises: Constructing a geometric model of the guidewire to be tested, wherein the geometric model includes a guidewire core model, a guide head model, and a hose model; According to the material distribution data, a finite element analysis of the static structure of the geometric model is performed to obtain the first flexibility data of the guide wire to be tested in a theoretical state.

3. The guidewire flexibility detection method according to claim 2, characterized in that: The material distribution data includes guide wire core material distribution data, guide head material distribution data and hose material distribution data. The step of performing finite element analysis of the static structure of the geometric model according to the material distribution data to obtain the first flexibility data of the guide wire to be tested in a theoretical state includes: Meshing the geometric model to obtain a mesh model of the guidewire to be detected, wherein the mesh model includes a guidewire core mesh model, a guide head mesh model, and a hose mesh model; Filling cells in the guide wire core grid model based on the guide wire core material distribution data to obtain a first material grid model; Filling cells in the guide head grid model based on the guide head material distribution data to obtain a second material grid model; Filling cells in the hose grid model based on the hose material distribution data to obtain a third material grid model; The first material grid model, the second material grid model, and the third material grid model form a model to be analyzed; Performing finite element analysis on the model to be analyzed by loading a plurality of the fixed loads respectively, to obtain a plurality of groups of finite element analysis results, each group of the finite element analysis results corresponding to one of the fixed loads; Based on multiple groups of the finite element analysis results, multiple first flexibility data of the guide wire to be tested in a theoretical state are determined, and each of the finite element analysis results corresponds to one first flexibility data.

4. The guidewire flexibility detection method according to claim 3, characterized in that: The finite element analysis result includes displacement data and stress data of each cell. The step of determining a plurality of the first flexibility data of the guide wire to be tested in a theoretical state based on the plurality of groups of the finite element analysis results includes: Determining a flexibility matrix corresponding to the finite element analysis result through the displacement data and the stress data; Based on the flexibility matrices corresponding to the multiple finite element analysis results, a plurality of the first flexibility data of the guide wire to be tested in a theoretical state are determined.

5. The guidewire flexibility detection method according to claim 1, characterized in that: The step of determining the flexibility detection result of the guidewire to be detected based on the plurality of the first flexibility data and the plurality of the second flexibility data comprises: Calculating the correlation between the first compliance data and the second compliance data under the same fixed load to obtain correlation values ​​under each fixed load; Calculating the average correlation value under all the fixed loads; If the average correlation value is less than a preset correlation threshold, determining that the flexibility test result of the guidewire to be tested is failed; If the average correlation value is greater than or equal to a preset correlation threshold, it is determined that the flexibility test result of the guidewire to be tested is passed.

6. An electronic device, characterized in that: include: A memory, a processor, and a computer program stored in the memory and executable on the processor, wherein when the processor executes the computer program, the steps in the guidewire flexibility detection method according to any one of claims 1 to 5 are implemented.

7. A computer-readable storage medium, characterized in that: The computer-readable storage medium stores a computer program, and when the computer program is executed by a processor, the steps in the guidewire flexibility detection method according to any one of claims 1 to 5 are implemented.

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