A hydrophilic coating angiographic catheter and its lubricant smart release system

Abstract

The application relates to the technical field of medical devices, and particularly discloses a hydrophilic coating angiography catheter and an intelligent lubricant release system thereof, wherein the hydrophilic coating angiography catheter comprises a data acquisition module, a basic running factor analysis module, a block area analysis module, a resistance factor analysis module, a resistance development analysis module and a lubricant release parameter determination module; the data acquisition module acquires a continuous angiography image sequence in front of the catheter and a real-time running distance; the basic running factor analysis module obtains a first running resistance factor of a basic running resistance factor based on image analysis of a blood vessel shape; the block area analysis module identifies a running block area, determines a latest relative position and a three-dimensional size of the running block area; the resistance factor analysis module combines related data to perform combined resistance effect analysis, obtains a running combined resistance factor and a second running resistance factor; the resistance development analysis module constructs a resistance factor analysis tree, fits a resistance change curve, and analyzes a plurality of resistance development factors; and the lubricant release parameter determination module outputs a lubricant release parameter control instruction based on the above factors; scientific and accurate control of lubricant release is realized, and the scientificity and effectiveness of catheter operation are improved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a hydrophilic coating angiography catheter and an intelligent lubricant release system thereof. BACKGROUND

[0002] In the field of medical intervention, angiography is a commonly used diagnostic method. By injecting contrast medium into specific parts of the body, the morphology and function of related organs or tissues can be observed using imaging devices. Angiography catheters are key devices for angiography, and their performance directly affects the effectiveness of the examination and the patient's experience. Traditional angiography catheters face frictional resistance when entering the human body's blood vessels, which can not only cause patient discomfort but also damage the inner wall of the blood vessel, increasing the risk of complications. In order to reduce this frictional resistance, hydrophilic coating technology is applied to angiography catheters. When in contact with liquid, the hydrophilic coating absorbs water to form a lubricating film, reducing the friction between the catheter and the surrounding tissue. However, the single hydrophilic coating technology has limitations, as its lubricating effect is difficult to dynamically adjust according to the actual situation of the catheter during its journey in the body. With the continuous progress of medical technology, intelligentization has become an important trend in the development of medical devices. It is of great significance to develop a system that can intelligently release lubricant in combination with a hydrophilic coating angiography catheter. Such a system can sense the state of the catheter in the body in real time, accurately control the release amount of lubricant according to different resistance conditions, further improve the lubricating performance of the catheter, reduce the adverse effects on the patient's body, and improve the safety and comfort of angiography. This not only helps to improve the accuracy of diagnosis, but also promotes the development of interventional therapy technology towards a more refined and humanized direction, and has broad application prospects in the fields of medical imaging diagnosis and interventional therapy.

[0003] However, existing angiography catheter technology has many shortcomings, such as the inability to fully understand the travel environment and state of the catheter in the body. It is difficult to accurately analyze the factors related to travel resistance, and ultimately to accurately control the release amount of lubricant according to the actual resistance conditions, so that the release of lubricant cannot match the actual resistance during the catheter's journey, affecting the lubricating effect of the catheter and the patient's experience.

[0004] Therefore, the present application proposes a hydrophilic coating angiography catheter and an intelligent lubricant release system thereof. SUMMARY

[0005] The application provides a hydrophilic coating angiography catheter and an intelligent lubricant release system thereof, a continuous angiography image sequence and a real-time running distance of a front of a catheter body are acquired by a data acquisition module, laying a foundation for subsequent analysis; a basic running factor analysis module obtains front local blood vessel morphology data and a first running resistance factor of a basic running resistance factor based on the image sequence, clarifying the basic resistance condition; a block region analysis module identifies the running block region in each angiography image, and determines the relative position and three-dimensional size of the block region in the latest image in combination with the real-time running distance, accurately positioning the block region; a combined resistance effect analysis is performed on the basis of the local blood vessel morphology and the block region information by a resistance factor analysis module, all running combined resistance factors and a second running resistance factor are obtained, and comprehensive resistance is fully evaluated; a resistance development analysis module constructs an analysis tree using related factors and fits a resistance change curve, obtains a resistance development factor, and predicts the resistance development trend; a lubricant release parameter determination module outputs a lubricant release parameter control instruction based on the first running resistance factor and the resistance development factor, scientifically and accurately controls the lubricant release, reasonably uses resources while ensuring smooth running of the catheter, improves the scientific nature and effectiveness of catheter operation, and also improves the lubricating effect of the catheter and the patient experience.

[0006] The application provides a hydrophilic coating angiography catheter, comprising:

[0007] A data acquisition module is configured to acquire a continuous angiography image sequence in front of a catheter body and a real-time running distance of the catheter body.

[0008] A basic running factor analysis module is configured to analyze front local blood vessel morphology data based on the continuous angiography image sequence, and obtain a first running resistance factor of all basic running resistance factors in the front local blood vessel morphology data.

[0009] A block region analysis module is configured to identify all running block regions in each angiography image in the continuous angiography image sequence, and determine the latest relative position and three-dimensional size of each running block region in the latest angiography image in combination with the real-time running distance of the catheter body.

[0010] A combined resistance factor analysis module is configured to perform arbitrary combined resistance effect analysis on all running block regions in the latest angiography image based on the front local blood vessel morphology data and the latest relative position and three-dimensional size of all running block regions in the latest angiography image, and obtain all running combined resistance factors of the latest angiography image and corresponding second running resistance factors.

[0011] A resistance development analysis module is configured to construct a resistance factor step-by-step combination analysis tree based on all running combined resistance factors and corresponding second running resistance factors, fit a plurality of running resistance change curves based on the resistance factor step-by-step combination analysis tree, and analyze a plurality of resistance development factors based on all running resistance change curves.

[0012] a lubricant release parameter determining module, configured to output a lubricant release parameter control instruction based on the first travel resistance factor of all the basic travel resistance factors and all the resistance development factors.

[0013] Preferably, the data acquisition module comprises:

[0014] a contrast sub-module, configured to acquire contrast images of a blood vessel region in front of the catheter body at a high frequency and form a continuous contrast image sequence by using a real-time X-ray angiography or fluoroscopy method;

[0015] a travel distance acquisition sub-module, configured to analyze and obtain actual displacement of the catheter body between adjacent frames based on inter-frame pixel displacement of the physical marker at the front end of the catheter body in the continuous contrast image sequence, and determine real-time travel distance of the catheter body based on the actual displacement of the catheter body between adjacent frames.

[0016] Preferably, the basic travel factor analysis module comprises:

[0017] a blood vessel morphology reading sub-module, configured to analyze local blood vessel morphology data in front based on the continuous contrast image sequence;

[0018] a travel resistance factor judgment sub-module, configured to judge whether each dimensional morphology data in the local blood vessel morphology data in front meets resistance factor formation threshold value data of a corresponding dimension, and if so, determine a corresponding basic travel resistance factor, and determine a first travel resistance factor of the corresponding basic travel resistance factor based on part of the dimensional morphology data that exceeds the resistance factor formation threshold value data of the corresponding dimension.

[0019] Preferably, the block region analysis module comprises:

[0020] a block region analysis sub-module, configured to identify all travel block regions in each contrast image in the continuous contrast image sequence and generate a plurality of travel block region sequences;

[0021] a position and size analysis sub-module, configured to determine all inter-frame pixel displacement data of each travel block region sequence, and determine a latest relative position and three-dimensional size of each travel block region in the latest contrast image in combination with real-time travel distance of the catheter body.

[0022] Preferably, the combined resistance factor analysis module comprises:

[0023] a blood vessel geometric coordinate system construction sub-module, configured to determine a local blood vessel centerline in front based on the local blood vessel morphology data in front, and construct a blood vessel geometric coordinate system with a current position of the physical marker at the front end of the catheter body as an origin and an extension direction of the local blood vessel centerline in front as a main direction of the coordinate system;

[0024] The position relationship coordinate expression submodule is configured to express the latest relative positions and three-dimensional sizes of all the travel blockage regions in the latest angiography image in a blood vessel geometric coordinate system, to obtain the axial position, radial position and circumferential angle of each travel blockage region in the latest angiography image, and to define the spatial relationship among all the travel blockage regions.

[0025] The resistance characteristic quantification submodule is configured to determine the stenosis rate, length-diameter ratio, cross-sectional irregularity, surface roughness of each travel blockage region and the adjacent axial distance between two adjacent travel blockage regions based on the axial position, radial position and circumferential angle of each travel blockage region in the latest angiography image.

[0026] The single-layer resistance factor calculation submodule is configured to determine the single-layer resistance factor of each travel blockage region based on the stenosis rate, length-diameter ratio, cross-sectional irregularity, surface roughness of each travel blockage region.

[0027] The travel blockage region combination submodule is configured to divide all the travel blockage regions in the latest angiography image into a plurality of sets of analysis-combined blockage regions based on the spatial relationship among all the travel blockage regions.

[0028] The combined resistance effect analysis submodule is configured to determine the single-layer travel resistance factor of each set of analysis-combined blockage regions, to perform combined resistance effect analysis on the single-layer resistance factors of all the travel blockage regions in each set of analysis-combined blockage regions, and to obtain the second travel resistance factor of all the travel combined resistance factors.

[0029] Preferably, the combined resistance effect analysis submodule comprises:

[0030] The travel combined resistance factor determination unit is configured to determine the corresponding travel combined resistance factor based on the range and spatial relationship of the travel blockage regions in each set of analysis-combined blockage regions.

[0031] The first combined resistance effect analysis unit is configured to calculate the second travel resistance factor of the corresponding travel combined resistance factor based on the single-layer resistance factors of all the travel blockage regions in the corresponding set of analysis-combined blockage regions and the axial distance between adjacent travel blockage regions when the spatial relationship among the travel blockage regions in the set of analysis-combined blockage regions is series connection.

[0032] The second combined resistance effect analysis unit is configured to calculate the second travel resistance factor of the corresponding travel combined resistance factor based on the single-layer resistance factors of all the travel blockage regions in the corresponding set of analysis-combined blockage regions, the flow area reduction ratio and the correction factor of the included angle between the catheter body travel direction and the coordinate principal direction of the blood vessel geometric coordinate system when the spatial relationship among the travel blockage regions in the set of analysis-combined blockage regions is parallel connection.

[0033] The third combined resistance effect analysis unit is configured to determine a blocking position coefficient corresponding to all the travel blocking regions in the set of combined blocking regions to be analyzed when a spatial relationship between the travel blocking regions in the set of combined blocking regions to be analyzed is a bifurcation blocking, and calculate a second travel resistance factor corresponding to the travel combined resistance factor based on the single-layer resistance factor of all the travel blocking regions in the set of combined blocking regions to be analyzed, the bifurcation angle coupling coefficient, the bifurcation angle, the branch number, and the blocking position coefficient of all the travel blocking regions.

[0034] Preferably, the resistance development analysis module comprises:

[0035] The resistance factor step-by-step combination analysis tree construction submodule is configured to construct a resistance factor step-by-step combination analysis tree based on all the travel combined resistance factors and the corresponding second travel resistance factors.

[0036] The travel resistance combination analysis context generation submodule is configured to combine any leaf relationship between adjacent levels in the resistance factor step-by-step combination analysis tree to obtain a plurality of travel resistance combination analysis contexts, wherein each travel resistance combination analysis context comprises any leaf relationship between adjacent levels.

[0037] The travel resistance change curve fitting submodule is configured to take the level where each node included in each travel resistance combination analysis context is located as the horizontal coordinate value, and take the corresponding travel resistance factor as the vertical coordinate value, to determine the coordinate value of each node included in each travel resistance combination analysis context in the two-dimensional coordinate, and based on the order of all the nodes included in each travel resistance combination analysis context, to smooth fit the coordinate values of all the nodes included in the corresponding travel resistance combination analysis context in the two-dimensional coordinate to obtain the corresponding travel resistance change curve.

[0038] The resistance development factor analysis submodule is configured to analyze a plurality of resistance development factors based on all the travel resistance change curves.

[0039] Preferably, the resistance development factor analysis submodule comprises:

[0040] The resistance curve feature analysis unit is configured to analyze the resistance change rate factor, the resistance amplitude factor, the resistance duration factor, the resistance frequency factor, and the resistance gradient factor of each travel resistance change curve.

[0041] The resistance development factor synthesis unit is configured to perform weighted summation on the resistance change rate factor, the resistance amplitude factor, the resistance duration factor, the resistance frequency factor, and the resistance gradient factor of each travel resistance change curve to obtain the resistance development factor of each travel resistance change curve.

[0042] Preferably, the lubricant release parameter determination module comprises:

[0043] a model construction submodule for constructing a lubricant release amount calculation model based on an artificial intelligence algorithm;

[0044] a release parameter determination submodule for inputting the first travel resistance factors of all basic travel resistance factors and all resistance development factors into the lubricant release amount calculation model to obtain lubricant release parameters in a future period;

[0045] a control instruction output submodule for outputting lubricant release parameter control instructions based on the lubricant release parameters in the future period.

[0046] The present application provides a lubricant intelligent release system of a hydrophilic coating angiographic catheter, which is used for receiving lubricant release parameter control instructions output from any one of the hydrophilic coating angiographic catheters in embodiments 1 to 9, and controlling a lubricant intelligent release device based on the lubricant release parameter control instructions.

[0047] The present application has the following beneficial effects compared with the prior art: the data acquisition module acquires a continuous angiographic image sequence in front of the catheter body and a real-time travel distance, laying a foundation for subsequent analysis; the basic travel factor analysis module obtains front local blood vessel morphology data and first travel resistance factors of basic travel resistance factors based on the image sequence, clarifying the basic resistance condition; the blockage region analysis module identifies travel blockage regions in each angiographic image, and determines the relative position and three-dimensional size of the blockage region in the latest image in combination with the real-time travel distance, accurately positioning the blockage region; the resistance factor analysis module analyzes the resistance effect according to the local blood vessel morphology and blockage region information, obtains all travel combined resistance factors and second travel resistance factors, and comprehensively evaluates the comprehensive resistance; the resistance development analysis module constructs an analysis tree using related factors and fits a resistance change curve, obtains resistance development factors, and predicts the resistance development trend; and the lubricant release parameter determination module outputs lubricant release parameter control instructions based on the first travel resistance factors and the resistance development factors, scientifically and accurately controls the lubricant release, reasonably uses resources while ensuring smooth travel of the catheter, improves the scientific nature and effectiveness of catheter operation, and also improves the lubricating effect of the catheter and the patient experience.

[0048] Other features and advantages of the present application will be set forth in the following description, and in part will become apparent to those skilled in the art from the description, or can be learned by practice of the present application. The objects and other advantages of the present application can be achieved and obtained by the structure particularly pointed out in the application file.

[0049] The technical solutions of the present application will be further described in detail below with the help of the drawings and embodiments. BRIEF DESCRIPTION OF DRAWINGS

[0050] The accompanying drawings are included to provide a further understanding of the application, and are incorporated in and constitute a part of this specification, illustrate embodiments of the application, and together with the description serve to explain the application, and do not limit the application. In the drawings:

[0051] Figure 1 A schematic diagram of a hydrophilic coating angiography catheter and its lubricant intelligent release system in an embodiment of the application;

[0052] Figure 2 A schematic diagram of the execution logic of a submodule of the data acquisition module in an embodiment of the application;

[0053] Figure 3 A schematic diagram of the execution logic of a submodule of the basic travel factor analysis module in an embodiment of the application. DETAILED DESCRIPTION

[0054] The preferred embodiments of the application are described below in conjunction with the accompanying drawings, and it should be understood that the preferred embodiments described here are only used to explain and illustrate the application, and do not limit the application.

[0055] Embodiment 1:

[0056] The application provides a hydrophilic coating angiography catheter, referring to Figure 1 , comprising:

[0057] A data acquisition module for acquiring a continuous angiography image sequence in front of the catheter body and a real-time travel distance of the catheter body;

[0058] A basic travel factor analysis module for analyzing local blood vessel morphology data in front based on the continuous angiography image sequence, and obtaining first travel resistance factors of all basic travel resistance factors in the local blood vessel morphology data in front;

[0059] A block region analysis module for identifying all travel block regions in each angiography image in the continuous angiography image sequence, and determining the latest relative position and three-dimensional size of each travel block region in the latest angiography image in combination with the real-time travel distance of the catheter body;

[0060] A combined resistance factor analysis module for performing arbitrary combined resistance effect analysis on all travel block regions in the latest angiography image based on the local blood vessel morphology data in front and the latest relative position and three-dimensional size of all travel block regions in the latest angiography image, to obtain all travel combined resistance factors and corresponding second travel resistance factors of the latest angiography image;

[0061] a resistance development analysis module configured to construct a resistance factor step-by-step combination analysis tree based on all the traveling combination resistance factors and corresponding second traveling resistance factors, and to fit a plurality of traveling resistance change curves based on the resistance factor step-by-step combination analysis tree, and to analyze a plurality of resistance development factors based on all the traveling resistance change curves;

[0062] a lubricant release parameter determination module configured to output a lubricant release parameter control instruction based on the first traveling resistance factors of all the basic traveling resistance factors and all the resistance development factors.

[0063] In this embodiment, the continuous contrast image sequence is formed by the contrast sub-module using real-time X-ray angiography or fluoroscopy method to collect contrast images of the blood vessel region in front of the catheter body at a high frequency. These images can accurately and frequently capture the dynamic changes of the blood vessel.

[0064] In this embodiment, the real-time traveling distance is obtained by the traveling distance acquisition sub-module based on the inter-frame pixel displacement of the physical marker at the front end of the catheter body in the continuous contrast image sequence to obtain the actual displacement of the catheter body between adjacent frames, and then determine the real-time traveling distance of the catheter.

[0065] In this embodiment, the front local blood vessel morphology data is obtained by the blood vessel morphology reading sub-module in the basic traveling factor analysis module based on the continuous contrast image sequence. It intuitively and critically presents the morphological characteristics of the local blood vessel in front of the catheter, such as the size of the vessel diameter, the degree of bending, etc.

[0066] In this embodiment, the basic traveling resistance factor is determined when a certain dimensional morphology data in the front local blood vessel morphology data meets the resistance factor formation threshold data of the corresponding dimension, which is related to the traveling resistance of the catheter. For example, the bending degree and the diameter change of the blood vessel may become the basic traveling resistance factor.

[0067] In this embodiment, the first traveling resistance factor is determined based on the part of the dimensional morphology data in the front local blood vessel morphology data that exceeds the resistance factor formation threshold data of the corresponding dimension for each basic traveling resistance factor. It quantifies the influence of each basic traveling resistance factor on the traveling resistance of the catheter, and the numerical value reflects the strength of the corresponding basic traveling resistance factor on the traveling resistance of the catheter, providing accurate and reliable data support for subsequent comprehensive evaluation of the traveling resistance of the catheter in the blood vessel.

[0068] In this embodiment, the contrast image is an image reflecting the condition of the blood vessel region in front of the catheter body collected by real-time X-ray angiography or fluoroscopy method.

[0069] In this embodiment, the advancing blocking region refers to the region that may hinder the advancement of the catheter, which is identified by the blocked region analysis submodule in each contrast image of the continuous contrast image sequence. These regions may be stenosis sites, plaques, branches, and other structures in the blood vessels.

[0070] In this embodiment, the latest relative position and three-dimensional size of the advancing blocking region are determined by the position and size analysis submodule based on the real-time advancing distance of the catheter body and the inter-frame pixel displacement data of each frame of the advancing blocking region sequence. The latest relative position specifies the spatial position of the advancing blocking region relative to the catheter body in the current latest contrast image, and the three-dimensional size specifically describes the size of the blocking region in space, including length, width, height, and other information.

[0071] In this embodiment, the advancing combined resistance factor is determined by the resistance factor analysis module based on the local blood vessel morphology data in front and the latest relative position and three-dimensional size of all advancing blocking regions in the latest contrast image. After analyzing the resistance effects of all advancing blocking regions in combination, the combined resistance factor considering various combinations of blocking conditions is determined. For example, there may be different spatial relationships such as series, parallel, and bifurcation between different advancing blocking regions, and these combinations together constitute the resistance influencing factor of the catheter advancement, which is the advancing combined resistance factor.

[0072] In this embodiment, the second advancing resistance factor is obtained by analyzing the combined resistance effects of all advancing blocking regions in the corresponding set of combined blocking regions to be analyzed for each advancing combined resistance factor. It quantifies the influence of each advancing combined resistance factor on the catheter advancement resistance, and considers various factors under different combinations of blocking regions, which can more realistically reflect the actual advancement resistance of the catheter in a complex blood vessel environment and provide accurate data support for subsequent reasonable response measures.

[0073] In this embodiment, the resistance factor step-by-step combination analysis tree is constructed based on all advancing combined resistance factors and corresponding second advancing resistance factors by the resistance development analysis module. It organizes different advancing combined resistance factors and their corresponding resistance factors in a hierarchical manner, providing an orderly framework for in-depth analysis of resistance development trends and facilitating an overall understanding of the relationships and change laws between resistance factors.

[0074] In this embodiment, the travel resistance change curve: the travel resistance combination analysis branch generates a plurality of travel resistance change curves by gradually combining the resistance factors with the leaf relationship between adjacent levels in the analysis tree, and then the travel resistance change curve fitting submodule determines the coordinate values of each node in the two-dimensional coordinate system based on the node order, and then smoothes and fits these coordinate values to obtain the travel resistance change curve.

[0075] In this embodiment, the resistance development factor: the resistance development factor analysis submodule obtains it based on all travel resistance change curves. It is obtained by weighting and summing the resistance change rate factor, resistance amplitude factor, resistance duration factor, resistance frequency factor, and resistance gradient factor of the resistance change curve. The resistance development factor quantifies the development trend of the resistance.

[0076] In this embodiment, the lubricant release parameter control instruction: the lubricant release parameter determination module inputs the first travel resistance factor of all basic travel resistance factors and all resistance development factors into the lubricant release amount calculation model to obtain the lubricant release parameter in the future period, and then outputs it by the control instruction output submodule. This instruction is used to control the intelligent lubricant release device.

[0077] Embodiment 2:

[0078] On the basis of embodiment 1, the data acquisition module, referring to Figure 2 , includes:

[0079] The contrast submodule is used to acquire contrast images of the blood vessel region in front of the catheter body at a high frequency and form a continuous contrast image sequence by using real-time X-ray angiography or fluoroscopy.

[0080] The travel distance acquisition submodule is used to analyze the actual displacement of the catheter body between adjacent frames based on the inter-frame pixel displacement of the physical marker at the front end of the catheter body in the continuous contrast image sequence, and determine the real-time travel distance of the catheter body based on the actual displacement of the catheter body between adjacent frames.

[0081] In this embodiment, real-time X-ray angiography is a medical imaging technology that captures blood vessel images in real time by emitting X-rays to penetrate the human body and using the difference in X-ray absorption or scattering characteristics between the contrast agent and the surrounding tissue.

[0082] In this embodiment, the fluoroscopy method: is also a medical imaging technology that uses X-rays to penetrate the human body and excite fluorescent substances to produce fluorescence, thereby displaying the internal structure of the human body in real time. In this system, this method is used to acquire contrast images of the blood vessel region in front of the catheter body at a high frequency and form a continuous sequence, just like real-time X-ray angiography.

[0083] In this embodiment, the physical marker at the front end of the catheter body: this is a specific mark set at the front end of the catheter body, which has unique image features so that it can be clearly identified in a sequence of continuous angiographic images. This physical marker is an important reference point for determining the position and displacement of the catheter, and by tracking its position changes in different frames of angiographic images, the progress of the catheter can be analyzed. For example, this physical marker can be a mark made of a special material that can form a clear contrast with the surrounding tissue under X-ray or fluoroscopy imaging, making it easy to be accurately identified and located in the image.

[0084] In this embodiment, inter-frame pixel displacement: refers to the change in the pixel position of the physical marker at the front end of the catheter body in adjacent two frames of angiographic images in a sequence of continuous angiographic images. Since continuous angiographic images are continuously acquired at a certain frequency, the position change information of the catheter in a very short time interval is recorded between adjacent frames. By analyzing the difference in pixel position of the physical marker in adjacent frames of images, i.e. the inter-frame pixel displacement, the position change of the catheter in this very short time can be obtained. For example, if the physical marker is located at a certain pixel coordinate position in one frame of image, and its pixel coordinate changes in the next frame of image, the difference between these two coordinates is the inter-frame pixel displacement.

[0085] In this embodiment, based on the inter-frame pixel displacement of the physical marker at the front end of the catheter body in a sequence of continuous angiographic images, the actual displacement of the catheter body between adjacent frames is analyzed and obtained: since the sequence of continuous angiographic images records the position of the physical marker at the front end of the catheter at different times, by measuring the pixel displacement of the physical marker in adjacent frames of images and combining the calibration parameters of the imaging system (such as the conversion relationship between pixels and actual distance, etc.), the pixel displacement can be converted into actual spatial displacement, and thus the actual moving distance of the catheter body between adjacent frames is obtained. For example, it is known that each pixel in the imaging system represents an actual length of 0.1 mm, and if the measured inter-frame pixel displacement of the physical marker is 10 pixels, then the actual displacement of the catheter between adjacent frames is 1 mm. This method of obtaining actual displacement based on image analysis provides an effective way to accurately determine the travel distance of the catheter.

[0086] In this embodiment, the real-time travel distance of the catheter body is determined based on the actual displacement of the catheter body between adjacent frames: after obtaining the actual displacement of the catheter between adjacent frames, the actual displacements between these adjacent frames are accumulated, and the real-time travel distance of the catheter from the start to the current time can be obtained. For example, 10 sets of actual displacement data between adjacent frames are continuously obtained, which are 1 mm, 1.2 mm, 0.8 mm, …, and these data are added in sequence to obtain the real-time travel distance of the catheter from the starting position to the current position.

[0087] The beneficial effects of the above technology are: the contrast sub-module adopts real-time X-ray angiography or fluoroscopy method to collect the angiography images of the blood vessel region in front of the catheter body at high frequency and form a continuous sequence, which enables the acquired images to capture the dynamic changes of the blood vessels at high precision and high frequency, provides rich and accurate image data basis for subsequent comprehensive and detailed analysis of the blood vessel conditions in front of the catheter, and ensures the timeliness and accuracy of the analysis. The travel distance acquisition sub-module analyzes the actual displacement between adjacent frames based on the pixel displacement of the physical marker at the front end of the catheter body in the continuous angiography image sequence, and then determines the real-time travel distance. This image analysis-based method is ingenious and accurate, does not require additional complex measurement equipment, and can obtain the catheter travel distance information in real time and accurately using existing image data, which is low in cost and closely related to image data, and provides accurate position change data for subsequent operations such as analysis of the catheter travel resistance based on blood vessel image analysis, which helps to improve the reliability and scientificity of the entire system for monitoring and analyzing the catheter travel state.

[0088] Embodiment 3:

[0089] On the basis of embodiment 1, the basic travel factor analysis module, referring to Figure 3 , includes:

[0090] The blood vessel morphology reading sub-module is configured to analyze the local blood vessel morphology data in front based on the continuous angiography image sequence.

[0091] The travel resistance factor judgment sub-module is configured to determine whether each dimension morphology data in the local blood vessel morphology data in front meets the resistance factor formation threshold data of the corresponding dimension, and if so, determine the corresponding basic travel resistance factor, and determine the first travel resistance factor of the corresponding basic travel resistance factor based on the part of the dimension morphology data that exceeds the resistance factor formation threshold data of the corresponding dimension.

[0092] In this embodiment, each dimension morphology data refers to specific data describing different aspects of the local blood vessel morphology in front. The blood vessel morphology can be described from multiple dimensions, such as the size of the blood vessel diameter (radial dimension), the degree of curvature of the blood vessel (which can be measured by curvature, which belongs to the spatial geometric dimension), the smoothness of the blood vessel wall (surface feature dimension), etc. These specific data of different aspects are each dimension morphology data.

[0093] In this embodiment, the resistance factor formation threshold data: for each dimension morphology data of the local blood vessel in front, the standard numerical value set for judging whether it constitutes a basic travel resistance factor. These threshold data are obtained based on medical knowledge, clinical experience and a large amount of experimental data. For example, for the dimension of blood vessel diameter, when the diameter is less than a certain specific value (i.e. the resistance factor formation threshold data), it may produce obvious resistance to the travel of the catheter. This specific value is the resistance factor formation threshold data of this dimension.

[0094] In this embodiment, it is determined whether each dimensional shape data in the front local blood vessel shape data meets the resistance factor forming threshold data of the corresponding dimension: the travel resistance factor judgment submodule in the basic travel factor analysis module compares each dimensional specific data in the front local blood vessel shape data with the pre-set resistance factor forming threshold data of the corresponding dimension. For example, the actual pipe diameter value of the blood vessel is compared with the resistance factor forming threshold data of the pipe diameter dimension to determine whether the actual pipe diameter is less than the threshold value; the actual bending degree index of the blood vessel is compared with the resistance factor forming threshold data of the bending degree dimension, and so on. Through such comparison and judgment, it is determined which dimensional blood vessel shape will have an impact on the travel of the catheter.

[0095] In this embodiment, the corresponding basic travel resistance factor is determined: when the dimensional shape data meets the resistance factor forming threshold data of the corresponding dimension, it is determined that the dimensional blood vessel shape feature constitutes a basic travel resistance factor. For example, if the pipe diameter of the blood vessel is less than the set threshold value, then "the pipe diameter of the blood vessel is too small" becomes a basic travel resistance factor; if the bending degree of the blood vessel exceeds the corresponding threshold value, "the blood vessel is excessively bent" is also determined as a basic travel resistance factor.

[0096] In this embodiment, the first travel resistance factor of the corresponding basic travel resistance factor is determined based on the part of the dimensional shape data that exceeds the resistance factor forming threshold data of the corresponding dimension: for the determined basic travel resistance factor, the part of the dimensional shape data that exceeds the resistance factor forming threshold data is further analyzed. For example, if the resistance factor forming threshold data of the pipe diameter of the blood vessel is 5 mm, and the actual pipe diameter is 3 mm, the part that exceeds the threshold value is 2 mm. According to the part of the data that exceeds, the first travel resistance factor of the corresponding basic travel resistance factor (here, "the pipe diameter of the blood vessel is too small") is determined through a specific calculation method (for example, the ratio of the value of the part that exceeds to the threshold value).

[0097] The beneficial effects of the above technology are: the blood vessel shape reading sub-module accurately analyzes the front local blood vessel shape data based on the continuous contrast image sequence, providing intuitive and key basic information for subsequent in-depth analysis of the catheter travel resistance, enabling researchers to clearly understand the morphological characteristics of the blood vessel, such as the pipe diameter and the bending degree. The travel resistance factor judgment sub-module scientifically determines the basic travel resistance factor and the first travel resistance factor by judging the relationship between the front local blood vessel shape data in each dimension and the corresponding dimension resistance factor forming threshold data. This threshold-based judgment method makes the identification and quantification of travel resistance factors more accurate, effectively distinguishes the influence of different blood vessel shapes on the catheter travel resistance, provides accurate and reliable data support for subsequent comprehensive evaluation of the catheter travel resistance in the blood vessel, helps to fully understand the basic resistance conditions faced by the catheter during the travel process, thereby providing a scientific basis for taking targeted measures to ensure the smooth travel of the catheter, and improves the scientificity and practicality of the entire analysis process.

[0098] Embodiment 4:

[0099] Based on the embodiment 1, the blocking area analysis module comprises:

[0100] The blocking area analysis sub-module is configured to identify all travel blocking areas in each contrast image in the continuous contrast image sequence and generate a plurality of travel blocking area sequences.

[0101] The position and size analysis sub-module is configured to determine all inter-frame pixel displacement data of each travel blocking area sequence, and determine the latest relative position and three-dimensional size of each travel blocking area in the latest contrast image in combination with the real-time travel distance of the catheter body.

[0102] In this embodiment, all travel blocking areas in each contrast image in the continuous contrast image sequence are identified, and a plurality of travel blocking area sequences are generated:

[0103] The blocking area analysis sub-module is used to analyze each contrast image in the continuous contrast image sequence. Through image processing techniques such as image recognition algorithms, based on the gray scale, texture and other feature differences of different regions in the contrast image, the regions that may hinder the travel of the catheter, i.e. the travel blocking areas, are identified. For example, in the angiogram, the plaque, stenosis site, blood vessel branch and other structures in the blood vessel may exhibit different characteristics from the normal blood vessel region, and thus are identified as travel blocking areas.

[0104] For each identified travel blockage region, its position change in different frame images is tracked as the image sequence proceeds, and a plurality of travel blockage region sequences are generated. Each sequence records the continuous change of a specific travel blockage region in consecutive angiography images, which helps to analyze the dynamic change of the blockage region over time and its relative relationship with the catheter travel. For example, the position and shape change of a certain vascular stenosis region in angiography images at different time can be reflected by the corresponding travel blockage region sequence.

[0105] In this embodiment, all inter-frame pixel displacement data of each travel blockage region sequence are determined, and combined with the real-time travel distance of the catheter body, the latest relative position and three-dimensional size of each travel blockage region in the latest angiography image are determined:

[0106] For each travel blockage region sequence, the inter-frame pixel displacement data are determined by analyzing the position difference of the travel blockage region in adjacent frame images in the sequence. That is, the pixel coordinate change of each travel blockage region in two adjacent frame images is measured to obtain its displacement information in the image plane. For example, if the top-left pixel coordinate of a travel blockage region in a frame image is (x1, y1) and changes to (x2, y2) in the next frame image, then the inter-frame pixel displacement in the x direction is (x2-x1) and in the y direction is (y2-y1).

[0107] Combined with the real-time travel distance information of the catheter body, since the travel of the catheter changes its spatial position relationship with the travel blockage region. By associating the inter-frame pixel displacement data with the real-time travel distance, using the geometric model of the imaging system and the related calibration parameters (such as the proportional relationship between pixels and actual distance, the conversion relationship between the image coordinate system and the actual space coordinate system, etc.), the pixel displacement in the image can be converted into the displacement in the actual space.

[0108] Based on the above converted actual displacement information, the latest relative position of each travel blockage region in the latest angiography image relative to the physical marker at the front end of the catheter body is determined. For example, taking the physical marker at the front end of the catheter body as the reference point, the coordinate position of the travel blockage region in the three-dimensional space is determined. At the same time, by analyzing the size change of the travel blockage region between consecutive frames and combining the imaging system's measurement principle of object size, the three-dimensional size of the travel blockage region, such as length, width and height, is determined.

[0109] The beneficial effects of the above technology are that the blocking area analysis submodule can identify all the traveling blocking areas in each contrast image in the continuous contrast image sequence and generate multiple traveling blocking area sequences, which makes a systematic and comprehensive record of various blocking situations encountered during catheter travel, clearly presents the distribution of traveling blocking areas at different times, and provides a complete data foundation for subsequent in-depth analysis. The position and size analysis submodule accurately determines the latest relative position and three-dimensional size of each traveling blocking area in the latest contrast image by determining the inter-frame pixel displacement data of each traveling blocking area sequence and combining the real-time travel distance of the catheter body. This combination makes full use of image sequence information and catheter travel information, making the determination of the position and size of the traveling blocking area more accurate. This is crucial for judging the influence of the traveling blocking area on the catheter travel and provides accurate data support for subsequent development of response strategies and adjustment of catheter travel plans.

[0110] Embodiment 5:

[0111] On the basis of embodiment 1, a resistance factor analysis module is combined, including:

[0112] A blood vessel geometric coordinate system construction submodule is used to determine the front local blood vessel centerline based on the front local blood vessel shape data, and a blood vessel geometric coordinate system is constructed with the current position of the physical marker at the front end of the catheter body as the origin and the extension direction of the front local blood vessel centerline as the coordinate main direction.

[0113] A position relationship coordinate representation submodule is used to represent the latest relative position and three-dimensional size of all the traveling blocking areas in the latest contrast image in the blood vessel geometric coordinate system, obtain the axial position, radial position, and circumferential angle of each traveling blocking area in the latest contrast image, and define the spatial relationship between all the traveling blocking areas.

[0114] A resistance characteristic quantification submodule is used to determine the stenosis rate, length-diameter ratio, cross-sectional irregularity, surface roughness of each traveling blocking area, and the adjacent axial distance between each pair of adjacent traveling blocking areas based on the axial position, radial position, and circumferential angle of each traveling blocking area in the latest contrast image.

[0115] A single-layer resistance factor calculation submodule is used to determine the single-layer resistance factor of each traveling blocking area based on the stenosis rate, length-diameter ratio, cross-sectional irregularity, and surface roughness of each traveling blocking area.

[0116] A traveling blocking area combination submodule is used to divide all the traveling blocking areas in the latest contrast image into multiple sets of combined blocking areas to be analyzed based on the spatial relationship between all the traveling blocking areas.

[0117] The combined resistance effect analysis submodule is configured to determine a single-level travel resistance factor of each set of combined blocking regions to be analyzed, and to perform combined resistance effect analysis on the single-level resistance factors of all travel blocking regions in each set of combined blocking regions to be analyzed, to obtain a second travel resistance factor of all travel combined resistance factors.

[0118] In this embodiment, the local blood vessel centerline in front is determined based on the local blood vessel morphology data in front: by performing specific mathematical analysis and image processing algorithms on the local blood vessel morphology data in front, a center trajectory line representing the direction of the blood vessel is found. For example, the center line can be calculated by using the geometric characteristics of the blood vessel morphology in the image, such as the symmetry of the blood vessel boundary, etc.

[0119] In this embodiment, the blood vessel geometric coordinate system: a coordinate system constructed with the current position of the physical marker at the front end of the catheter body as the origin and the extension direction of the local blood vessel centerline in front as the main direction of the coordinate. This coordinate system is specially designed for analyzing the situation of the catheter in the blood vessel, so that the positions of various structures in the blood vessel (such as travel blocking regions) can be described in a unified coordinate framework, facilitating the quantification and analysis of various factors in the catheter travel process, and being more suitable for the actual situation in the blood vessel compared to general coordinate systems.

[0120] In this embodiment, the axial position, radial position and circumferential angle of each travel blocking region in the latest contrast image: in the blood vessel geometric coordinate system, the axial position represents the position of the travel blocking region along the direction of the blood vessel centerline, reflecting its distribution in the length direction of the blood vessel; the radial position refers to the perpendicular distance of the travel blocking region from the blood vessel centerline, reflecting its proximity to the center in the cross-sectional view of the blood vessel; the circumferential angle is the position angle of the region in the circumferential direction of the blood vessel cross-section, describing its orientation in the circumference with respect to a reference direction. Through these three parameters, the spatial position of each travel blocking region in the blood vessel can be accurately determined.

[0121] In this embodiment, the spatial relationship between all travel blocking regions is defined: according to the axial position, radial position and circumferential angle of each travel blocking region in the blood vessel geometric coordinate system, the relative positions and distribution of the travel blocking regions are analyzed to determine their spatial relationship. For example, it is determined whether two travel blocking regions are arranged in front of each other (in series), side by side (in parallel), or at a blood vessel bifurcation, etc.

[0122] In this embodiment, the stenosis rate, length-diameter ratio, cross-sectional irregularity, surface roughness of each travel blocking region, and the adjacent axial distance between two adjacent travel blocking regions are determined based on the axial position, radial position and circumferential angle of each travel blocking region in the latest contrast image:

[0123] Stenosis rate: By the radial position of the travel blockage region and other information, the reduction ratio of the cross-sectional area of the region relative to the normal blood vessel cross-sectional area is calculated, reflecting the stenosis degree of the blood vessel.

[0124] Length-diameter ratio: The length of the travel blockage region along the axial direction of the blood vessel is determined in combination with the axial position, and compared with the radial dimension of the region to obtain the length-diameter ratio, which is used to evaluate the influence of the shape characteristics of the blockage region on the resistance.

[0125] Cross-sectional irregularity: According to the shape complexity of the travel blockage region on the blood vessel cross-section (judged comprehensively by the circumferential angle and radial position and other information), the cross-sectional irregularity is determined, which reflects the degree of deviation of the cross-sectional shape from a regular circle, and the higher the irregularity, the greater the interference with blood flow and catheter travel.

[0126] Surface roughness: By analyzing the texture features of the surface of the travel blockage region in the contrast image (compared with the surrounding normal blood vessel wall), the surface roughness is determined, which reflects the smoothness of the surface and affects the friction between the catheter and the surface of the travel blockage region.

[0127] Adjacent axial spacing: For two adjacent travel blockage regions, the distance in the axial direction of the blood vessel is calculated according to their axial positions, and this spacing affects the superposition manner of multiple travel blockage regions on the catheter travel resistance.

[0128] In this embodiment, the single-layer resistance factor of each travel blockage region is determined based on the stenosis rate, length-diameter ratio, cross-sectional irregularity, and surface roughness of each travel blockage region: By using the above-mentioned quantitative characteristic parameters, a specific mathematical model or empirical formula is used to comprehensively calculate the quantitative index of the resistance of each travel blockage region to the catheter travel, i.e. the single-layer resistance factor. It reflects the degree of resistance caused by a single travel blockage region to the catheter travel due to its own geometric shape, surface characteristics, etc. The specific mathematical model or empirical formula is as follows:

[0129]

[0130] In the formula, the single-layer resistance factor of a single travel blockage region, α, β, γ are weight coefficients (constants calibrated by experiments or clinical data, used to quantify the contribution proportion of different resistance factors), ΔD is the diameter change of the blood vessel caused by the travel blockage region (such as the diameter reduction of the stenosis segment, unit: mm), D0 is the original diameter of the blood vessel upstream of the travel blockage region (the diameter of the normal blood vessel without blockage, unit: mm), and L is the axial length of the travel blockage region (such as the length of the stenosis segment or plaque, unit: mm).

[0131] In this embodiment, the single-layer resistance factor of the travel blocking area is a numerical value quantifying the degree of the travel blocking of the catheter by the single travel blocking area. The larger the numerical value, the greater the resistance of the area to the travel of the catheter.

[0132] In this embodiment, based on the spatial relationship among all the travel blocking areas, all the travel blocking areas in the latest contrast image are divided into a plurality of sets of analysis combined blocking areas: according to the spatial relationship among the travel blocking areas defined above, such as series, parallel, bifurcation, etc., the travel blocking areas with similar spatial relationship are grouped into a set, forming a plurality of sets of analysis combined blocking areas.

[0133] The above-mentioned technical beneficial effects are: the blood vessel geometric coordinate system construction submodule determines the center line based on the front local blood vessel shape data, and constructs the coordinate system with the physical marker position at the front end of the catheter body as the origin, thereby providing a unified and targeted spatial reference system for subsequent analysis, making the description of the position and relationship of the travel blocking area more accurate and intuitive, and facilitating the subsequent analysis based on the same standard. The position relationship coordinate expression submodule expresses the position and size of the travel blocking area in the coordinate system, clearly defines the axial, radial position and circumferential angle of each travel blocking area and defines the spatial relationship, which helps to deeply understand the spatial distribution characteristics of different travel blocking areas in the blood vessel, and lays a foundation for accurately evaluating the comprehensive influence. The resistance characteristic quantification submodule quantifies the resistance characteristics of the travel blocking area from different dimensions by determining multiple key indicators such as the stenosis rate and length-diameter ratio, so that the resistance characteristics of each travel blocking area are more detailed, and the accuracy of the analysis is improved. The single-layer resistance factor calculation submodule determines the single-layer resistance factor according to the above-mentioned quantitative indicators, realizes the preliminary quantification of the resistance of the single travel blocking area, and provides basic data for subsequent combined analysis. The travel blocking area combination submodule divides the sets of analysis combined blocking areas based on the spatial relationship, which takes into account the synergistic effect of different blocking area combinations, and is more in line with the actual complex blood vessel environment. The combined resistance effect analysis submodule analyzes the combined resistance effect of each set to obtain the second travel resistance factor of all the travel combined resistance factors, comprehensively considers the resistance under the combination of multiple factors, and can more truly reflect the actual travel resistance of the catheter in the complex blood vessel environment.

[0134] Embodiment 6:

[0135] On the basis of embodiment 5, the combined resistance effect analysis submodule comprises:

[0136] A travel combined resistance factor determination unit is configured to determine a corresponding travel combined resistance factor based on the range and spatial relationship of the travel blocking area in each set of analysis combined blocking area;

[0137] the first combined resistance effect analysis unit is configured to calculate a second flow resistance factor of a corresponding flow combined resistance factor based on single-layer resistance factors of all flow resistance regions in the corresponding set of combined resistance regions to be analyzed and axial distances between adjacent flow resistance regions when a spatial relationship between the flow resistance regions in the set of combined resistance regions to be analyzed is series resistance;

[0138] the second combined resistance effect analysis unit is configured to calculate a second flow resistance factor of a corresponding flow combined resistance factor based on single-layer resistance factors of all flow resistance regions in the corresponding set of combined resistance regions to be analyzed, a flow area reduction ratio, and a correction factor of an angle between a flow direction of the catheter body and a coordinate principal direction of a blood vessel coordinate system when a spatial relationship between the flow resistance regions in the set of combined resistance regions to be analyzed is parallel resistance;

[0139] the third combined resistance effect analysis unit is configured to determine resistance position coefficients of all flow resistance regions in the corresponding set of combined resistance regions to be analyzed, and calculate a second flow resistance factor of a corresponding flow combined resistance factor based on single-layer resistance factors of all flow resistance regions in the corresponding set of combined resistance regions to be analyzed, a bifurcation angle coupling coefficient, a bifurcation angle, a branch number, and the resistance position coefficients of all flow resistance regions when a spatial relationship between the flow resistance regions in the set of combined resistance regions to be analyzed is bifurcation resistance.

[0140] In this embodiment, a corresponding flow combined resistance factor is determined based on a range and a spatial relationship of flow resistance regions in each set of combined resistance regions to be analyzed, for example, the flow combined resistance factor is a combined resistance factor of series flow resistance regions in the region A.

[0141] In this embodiment, the second flow resistance factor of the corresponding flow combined resistance factor is calculated based on single-layer resistance factors of all flow resistance regions in the corresponding set of combined resistance regions to be analyzed and axial distances between adjacent flow resistance regions, including:

[0142]

[0143] In the formula, R 总1 is the second flow resistance factor of the corresponding flow combined resistance factor when the spatial relationship between the flow resistance regions in the set of combined resistance regions to be analyzed is series resistance, R 11 , R 12 , …, R 1n are single-layer resistance factors of the first to nth flow resistance regions in the corresponding set of combined resistance regions to be analyzed, and δ is a distance coupling coefficient (a constant for quantifying a turbulent coupling resistance increment of adjacent resistance regions due to too close distance, and the value is 0.1 to 0.8). ijThe axial spacing (unit: mm, normalized to D0 or directly using physical distance) between the ith and the jth adjacent blocking regions.

[0144] In this embodiment, based on the single-layer resistance factor and the flow area reduction ratio of all the traveling blocking regions in the set of combined blocking regions to be analyzed, and the correction factor of the angle between the traveling direction of the catheter body and the coordinate principal direction of the blood vessel geometric coordinate system, the second traveling resistance factor of the corresponding traveling combined resistance factor is calculated, including:

[0145]

[0146] In the formula, R 总2 is the second traveling resistance factor of the corresponding traveling combined resistance factor when the spatial relationship between the traveling blocking regions in the set of combined blocking regions to be analyzed is parallel blocking, R 21 is the second traveling resistance factor of the corresponding traveling combined resistance factor when the spatial relationship between the traveling blocking regions in the set of combined blocking regions to be analyzed is series blocking, R 22 is the second traveling resistance factor of the corresponding traveling combined resistance factor when the spatial relationship between the traveling blocking regions in the set of combined blocking regions to be analyzed is bifurcation blocking, and R 2n is the single-layer resistance factor of the first to the nth traveling blocking region in the set of combined blocking regions to be analyzed, η1, η2, …, η n is the flow area reduction ratio of the position where the first to the nth traveling blocking region is located, is the correction factor of the angle between the traveling direction of the catheter body and the coordinate principal direction of the blood vessel geometric coordinate system, the value range is 1 to 1.2, 1 when the angle is 0 degree or 180 degree, and 1.2 when the angle is 90 degrees.

[0147] In this embodiment, the blocking position coefficient of all the traveling blocking regions in the set of combined blocking regions to be analyzed is determined, that is, when the traveling blocking region is located at the proximal end of the main branch, the blocking position coefficient λ = 1, when the traveling blocking region is located at the branch opening, the blocking position coefficient λ = 0.5, and when the traveling blocking region is located at the distal end of the main branch, the blocking position coefficient λ = 0.8.

[0148] In this embodiment, based on the single-layer resistance factor, the bifurcation angle coupling coefficient, the bifurcation angle, the number of branches, and the blocking position coefficient of all the traveling blocking regions of all the traveling blocking regions in the set of combined blocking regions to be analyzed, the second traveling resistance factor of the corresponding traveling combined resistance factor is calculated, including:

[0149]

[0150] In the formula, R 总3 is the second traveling resistance factor of the corresponding traveling combined resistance factor when the spatial relationship between the traveling blocking regions in the set of combined blocking regions to be analyzed is parallel blocking, R 31 is the second traveling resistance factor of the corresponding traveling combined resistance factor when the spatial relationship between the traveling blocking regions in the set of combined blocking regions to be analyzed is series blocking, R 32 is the second traveling resistance factor of the corresponding traveling combined resistance factor when the spatial relationship between the traveling blocking regions in the set of combined blocking regions to be analyzed is bifurcation blocking, and R 3nμ is a single-layer resistance factor corresponding to the first to the nth travel resistance region in the set of combined resistance regions to be analyzed, μ is a bifurcation angle coupling coefficient (fitted by CFD simulation or clinical data), cosθ is the cosine value of the bifurcation angle θ, k is the branch number, m is the total number of travel resistance regions in the set of combined resistance regions to be analyzed, λ j The resistance position coefficient of the jth travel resistance region.

[0151] The beneficial effects of the above technology are: the travel combination resistance factor determination unit determines the travel combination resistance factor based on the travel resistance region range and spatial relationship, which can accurately identify the resistance factor under different combination forms, provides clear object definition for subsequent accurate analysis, and improves the pertinence of analysis. The first combination resistance effect analysis unit calculates the second travel resistance factor by comprehensively considering the single-layer resistance factor and the axial distance of adjacent regions for the series resistance case, fully considers the transmission and superposition characteristics of resistance under this resistance form, and can more accurately reflect the influence of series resistance on the travel resistance of the catheter, and provides accurate data support for coping with such cases. The second combination resistance effect analysis unit calculates the resistance factor by combining the single-layer resistance factor, the flow area reduction ratio and the angle correction factor when in parallel resistance, fully covers the key elements affecting the resistance under parallel resistance, effectively quantifies the travel resistance under parallel conditions, and improves the accuracy of resistance analysis under complex blood vessel conditions. The third combination resistance effect analysis unit calculates the resistance factor by determining the resistance position coefficient and combining a plurality of related parameters for the bifurcation resistance, carefully considers the influence of the special geometric structure and mechanical properties of the bifurcation resistance on the resistance, so that the resistance analysis of the bifurcation travel resistance region is more comprehensive and accurate.

[0152] Embodiment 7:

[0153] On the basis of embodiment 1, the resistance development analysis module comprises:

[0154] The resistance factor step-by-step combination analysis tree construction submodule is used to construct a resistance factor step-by-step combination analysis tree based on all travel combination resistance factors and corresponding second travel resistance factors;

[0155] The travel resistance combination analysis context generation submodule is used to randomly combine the leaf relationships between adjacent levels in the resistance factor step-by-step combination analysis tree to obtain a plurality of travel resistance combination analysis contexts, wherein each travel resistance combination analysis context contains any leaf relationship between adjacent levels.

[0156] The travel resistance change curve fitting sub-module is configured to take the level of each node contained in each travel resistance combination analysis context as a horizontal coordinate value and take the corresponding travel resistance factor as a vertical coordinate value, determine the coordinate value of each node contained in each travel resistance combination analysis context in a two-dimensional coordinate, and based on the sequence of all nodes contained in each travel resistance combination analysis context, smooth fit the coordinate value of all nodes contained in the corresponding two-dimensional coordinate to obtain the corresponding travel resistance change curve.

[0157] The resistance development factor analysis sub-module is configured to analyze a plurality of resistance development factors based on all travel resistance change curves.

[0158] In this embodiment, a resistance factor step-by-step combination analysis tree is constructed based on all travel combination resistance factors and the corresponding second travel resistance factors, that is,

[0159] The travel combination resistance factor is taken as a node, the corresponding second travel resistance factor is taken as an attribute associated with the node, and a tree structure is constructed according to a certain logical relationship. This tree structure reflects the hierarchical relationship between different travel combination resistance factors and their comprehensive influence on the catheter travel resistance. For example, some basic and simple travel combination resistance factors can be taken as lower-level nodes according to the complexity of the resistance factors or the importance of the resistance contribution, and more complex resistance factors formed by the combination of these basic factors can be taken as higher-level nodes.

[0160] The beneficial effects of the above technology are that the resistance factor step-by-step combination analysis tree construction sub-module builds an analysis tree with travel combination resistance factors and second travel resistance factors, structures and sorts resistance information, and lays an orderly framework for in-depth analysis; the travel resistance combination analysis context generation sub-module generates a plurality of contexts by analyzing the relationship between adjacent levels of the leaves of the analysis tree, explores resistance correlations in multiple paths, and avoids missing important information; the travel resistance change curve fitting sub-module converts context node information into a two-dimensional coordinate and fits a curve, visually presents the resistance change trend, and facilitates quick insight into the characteristics; the resistance development factor analysis sub-module extracts a plurality of resistance development factors according to the curve, and provides quantitative indicators for evaluating the resistance development trend; and the overall module provides comprehensive and scientific basis for catheter operation decision-making from multiple aspects, helps the operator to predict and respond to resistance changes, and ensures the smooth travel of the catheter.

[0161] Embodiment 8:

[0162] Based on embodiment 7, the resistance development factor analysis sub-module includes:

[0163] The resistance curve characteristic analysis unit is configured to analyze the resistance change rate factor, the resistance amplitude factor, the resistance duration factor, the resistance frequency factor, and the resistance gradient factor of each travel resistance change curve.

[0164] The resistance development factor synthesis unit is configured to perform weighted summation on the resistance change rate factor, the resistance amplitude factor, the resistance duration factor, the resistance frequency factor, and the resistance gradient factor of each of the travel resistance change curves to obtain a resistance development factor of each of the travel resistance change curves.

[0165] In this embodiment, the resistance change rate factor, the resistance amplitude factor, the resistance duration factor, the resistance frequency factor, and the resistance gradient factor of each of the travel resistance change curves are analyzed, including:

[0166] The resistance change rate factor reflects the speed at which the travel resistance changes with the catheter advancing (or time). It is determined by calculating the slope of the travel resistance change curve at different points. The larger the slope, the faster the resistance changes at that stage. For example, if the catheter travel resistance increases rapidly within a certain period of time, the value of the resistance change rate factor will be larger.

[0167] The resistance amplitude factor refers to the maximum resistance value (or the maximum resistance value within a certain interval) in the travel resistance change curve. It reflects the maximum resistance that the catheter may encounter during the advancing process, and is an important indicator for evaluating whether the catheter can smoothly pass through certain regions.

[0168] The resistance duration factor represents the length of time that the resistance remains at a certain level (or interval). It helps to judge the impact of long-term resistance on the catheter and blood vessels. For example, long-term high resistance may increase the risk of damage to the blood vessel wall or affect the accuracy of the contrast examination.

[0169] The resistance frequency factor reflects the frequency of resistance fluctuations during the catheter advancing process. It can be determined by counting the number of times the resistance rises and falls in the travel resistance change curve. A higher resistance frequency factor means that the catheter advancing environment is unstable, and there may be complex blood vessel structures or lesions, which requires the system to more flexibly adjust the amount of lubricant release to cope with frequent changes in resistance.

[0170] The resistance gradient factor is used to measure the steepness of resistance changes within a certain interval. It is different from the resistance change rate factor, and focuses more on describing the sharpness of resistance changes within a relatively short interval. For example, if the resistance rapidly rises or falls within a short distance in a local region of the resistance change curve, the resistance gradient factor of that region will be larger, which may indicate that the catheter encounters special blood vessel structures or obstacles, which need special attention.

[0171] In this embodiment, the resistance change rate factor, the resistance amplitude factor, the resistance duration factor, the resistance frequency factor and the resistance gradient factor of each advancing resistance change curve are weighted and summed to obtain the resistance development factor of each advancing resistance change curve, including:

[0172] Considering that different factors have different degrees of influence on the resistance development trend, each factor is given a corresponding weight. The determination of these weights can be based on medical knowledge, clinical experience, a large amount of experimental data or optimized by a machine learning algorithm. For example, if the resistance amplitude factor has a more critical impact on the safety of the catheter in a specific vascular environment or catheter operation scenario, a relatively high weight is given to it.

[0173] Then the five factors of each advancing resistance change curve are multiplied by the respective weights and added to obtain a comprehensive numerical value, i.e. the resistance development factor. This factor integrates the resistance characteristic information of multiple dimensions into a single quantitative indicator, fully reflecting the resistance development trend represented by the curve. For example, for a resistance change curve, the resistance change rate factor weight is 0.2, the amplitude factor weight is 0.3, the duration factor weight is 0.2, the frequency factor weight is 0.1, and the gradient factor weight is 0.2. Assuming that the values of the factors are 0.5, 0.8, 0.6, 0.4 and 0.7 respectively, then the resistance development factor = 0.2 x 0.5 + 0.3 x 0.8 + 0.2 x 0.6 + 0.1 x 0.4 + 0.2 x 0.7 = 0.64.

[0174] The beneficial effects of the above techniques are that the resistance curve characteristic analysis unit analyzes each advancing resistance change curve from multiple dimensions to obtain the resistance change rate factor, the resistance amplitude factor, the resistance duration factor, the resistance frequency factor and the resistance gradient factor. The resistance development factor synthesis unit performs weighted summation on these factors of different dimensions to obtain the resistance development factor of each advancing resistance change curve. This comprehensive approach fully considers multiple key factors affecting the resistance development, integrates complex multi-dimensional information into a single quantitative indicator, making the evaluation of the resistance development more concise and comprehensive. The operator can more intuitively and accurately grasp the overall development trend of the resistance during the catheter advancement through this comprehensive resistance development factor, providing a strong basis for developing a more scientific and reasonable catheter operation strategy, and significantly improving the depth and practicality of the analysis of the advancing resistance of the catheter.

[0175] Embodiment 9:

[0176] On the basis of embodiment 1, the lubricant release parameter determination module comprises:

[0177] The model construction submodule is configured to construct a lubricant release amount calculation model based on an artificial intelligence algorithm.

[0178] The release parameter determination submodule is configured to input all first travel resistance factors of the basic travel resistance factors and all resistance development factors into the lubricant release amount calculation model to obtain the lubricant release parameter in the future period;

[0179] The control instruction output submodule is configured to output the lubricant release parameter control instruction based on the lubricant release parameter in the future period.

[0180] In this embodiment, the lubricant release amount calculation model is constructed based on an artificial intelligence algorithm. Data related to force and lubricant release, such as basic travel resistance factors, resistance development factors, actual resistance conditions in different vascular environments, and corresponding lubricant release amounts, are used. Using these data, the algorithm automatically mines the complex relationships and patterns hidden in the data through deep learning, machine learning, and other techniques. For example, the algorithm analyzes how the vessel diameter and the degree of curvature in the basic travel resistance factors jointly affect the reasonable release amount of the lubricant along with the resistance development factors. Through learning from a large amount of data, the algorithm can construct a mathematical model that can accurately calculate the appropriate lubricant release amount based on the input of the first travel resistance factors of the basic travel resistance factors and the resistance development factors. For example, based on a neural network algorithm, the model's output (lubricant release amount) is adjusted to be as close as possible to the actual demand by continuously adjusting the weights and biases in the network, thereby achieving the purpose of accurately calculating the lubricant release amount.

[0181] In this embodiment, the lubricant release parameter in the future period, for example, the model may output that the lubricant should be released at a rate of 5 milliliters per minute in the next 5 minutes.

[0182] The beneficial effects of the above technology are as follows: The model construction submodule constructs the lubricant release amount calculation model with the help of an artificial intelligence algorithm, fully utilizes the powerful data processing and analysis capabilities of artificial intelligence, accurately mines the complex internal relationships between the basic travel resistance factors, the resistance development factors, and the lubricant release amount, and provides strong model support for subsequent accurate determination of the release parameter. The release parameter determination submodule inputs all first travel resistance factors of the basic travel resistance factors and all resistance development factors into the model, comprehensively considers various factors that affect the release of the lubricant, and thus obtains relatively accurate lubricant release parameters in the future period, so that the release amount of the lubricant closely matches the actual resistance conditions during the travel of the catheter, avoids excessive or insufficient release, and effectively improves the use efficiency of the lubricant. The control instruction output submodule outputs the control instruction based on the obtained release parameter, realizes seamless connection from parameter determination to actual control, can timely and accurately regulate and control the lubricant release device, ensures the release of the lubricant according to the demand in the future period, provides reliable protection for the smooth travel of the catheter in a complex vascular environment, and improves the overall safety and effectiveness of the catheter operation.

[0183] Embodiment 10:

[0184] The present application provides a kind of lubricant intelligent release system of hydrophilic coating angiography catheter, for receiving the lubricant release parameter control instruction output from any one of hydrophilic coating angiography catheter in example 1 to 9, while based on lubricant release parameter control instruction control lubricant intelligent release device.

[0185] In this embodiment, the lubricant intelligent release device is the device responsible for the actual execution of the lubricant release operation in the entire hydrophilic coating angiography catheter system. It receives the lubricant release parameter control instruction output from the hydrophilic coating angiography catheter, and accurately controls the release of the lubricant according to these instructions. For example, the control instruction may specify the release rate, release amount, etc. of the lubricant in the future period of time, and the lubricant intelligent release device will release the lubricant to the part of the catheter in contact with the blood vessel according to these requirements through the internal mechanical structure, electronic control system and related driving components.

[0186] The beneficial effects of the above technology are: it can integrate the control instructions based on various complex analyses under different embodiments, fully utilize the achievements obtained in the early stage of resistance analysis, model construction, etc., and provide comprehensive and accurate basis for lubricant release control. Based on the received control instruction, the lubricant intelligent release device is controlled, realizing the automatic connection from data analysis to actual operation, greatly improving the accuracy and timeliness of lubricant release. It can accurately adjust the amount of lubricant release according to the real-time resistance condition of the catheter advancing in the blood vessel, and avoid unreasonable lubricant release caused by improper or lagging human operation. This intelligent release system helps to improve the safety and stability of catheter operation, reduces the friction between the catheter and the blood vessel wall by accurately controlling the release of lubricant, reduces the risk of damage to the blood vessel, and ensures the smooth progress of medical operation.

[0187] Obviously, those skilled in the art can make various modifications and variations to the present application without departing from the spirit and scope of the present application. Thus, if these modifications and variations of the present application fall within the scope of the present application and its equivalent technology, the present application also intends to include these modifications and variations.

Claims

1. A hydrophilic coated angiographic catheter characterized by, The method comprises the following steps: The data acquisition module is used to acquire a continuous angiography image sequence in front of the catheter body and a real-time running distance of the catheter body; The basic running factor analysis module is used to analyze the local blood vessel shape data in front based on the continuous angiography image sequence, and obtain the first running resistance factor of all basic running resistance factors in the local blood vessel shape data in front; The blocking area analysis module is used to identify all running blocking areas in each angiography image in the continuous angiography image sequence, and determine the latest relative position and three-dimensional size of each running blocking area in the latest angiography image in combination with the real-time running distance of the catheter body; The combined resistance factor analysis module is used to analyze the arbitrary combined resistance effect of all running blocking areas in the latest angiography image based on the local blood vessel shape data in front and the latest relative position and three-dimensional size of all running blocking areas in the latest angiography image, and obtain all running combined resistance factors of the latest angiography image and corresponding second running resistance factors; The resistance development analysis module is used to construct a running resistance factor step-by-step combined analysis tree based on all running combined resistance factors and corresponding second running resistance factors, fit a plurality of running resistance change curves based on the running resistance factor step-by-step combined analysis tree, and analyze a plurality of resistance development factors based on all running resistance change curves; The lubricant release parameter determination module is used to output a lubricant release parameter control instruction based on the first running resistance factors of all basic running resistance factors and all resistance development factors.

2. The hydrophilic coated angiographic catheter of claim 1, wherein, The data acquisition module comprises: The angiography sub-module is used to acquire angiography images of a blood vessel region in front of the catheter body at a high frequency by using a real-time X-ray angiography or fluoroscopy method, and form a continuous angiography image sequence; The running distance acquisition sub-module is used to analyze and obtain the actual displacement of the catheter body between adjacent frames based on the inter-frame pixel displacement of the physical marker at the front end of the catheter body in the continuous angiography image sequence, and determine the real-time running distance of the catheter body based on the actual displacement of the catheter body between adjacent frames.

3. The hydrophilic coated angiographic catheter of claim 1 wherein, The basic running factor analysis module comprises: The blood vessel shape reading sub-module is used to analyze the local blood vessel shape data in front based on the continuous angiography image sequence; The running resistance factor judgment sub-module is used to judge whether each dimensional shape data in the local blood vessel shape data in front meets the resistance factor formation threshold value data of the corresponding dimension, and if so, determine the corresponding basic running resistance factor, and determine the first running resistance factor of the corresponding basic running resistance factor based on the part of the dimensional shape data that exceeds the resistance factor formation threshold value data of the corresponding dimension.

4. The hydrophilic coated angiographic catheter of claim 1 wherein, The blocking area analysis module comprises: The blocking area analysis sub-module is used to identify all running blocking areas in each angiography image in the continuous angiography image sequence, and generate a plurality of running blocking area sequences; The position and size analysis sub-module is used to determine all inter-frame pixel displacement data of each running blocking area sequence, and determine the latest relative position and three-dimensional size of each running blocking area in the latest angiography image in combination with the real-time running distance of the catheter body.

5. The hydrophilic coated angiographic catheter of claim 1 wherein, The combined resistance factor analysis module comprises: The blood vessel geometry coordinate system construction submodule is configured to determine a front local blood vessel centerline based on the front local blood vessel morphology data, and construct a blood vessel geometry coordinate system with a physical marker at the front end of the catheter body as an origin and an extension direction of the front local blood vessel centerline as a main coordinate direction; The position relationship coordinate representation submodule is configured to represent the latest relative positions and three-dimensional sizes of all the travel blocking regions in the latest contrast image in the blood vessel geometry coordinate system, to obtain the axial position, radial position and circumferential angle of each travel blocking region in the latest contrast image, and to define the spatial relationship between all the travel blocking regions; The resistance characteristic quantification submodule is configured to determine the stenosis rate, length-diameter ratio, cross-sectional irregularity, surface roughness of each travel blocking region and the adjacent axial distance between two adjacent travel blocking regions based on the axial position, radial position and circumferential angle of each travel blocking region in the latest contrast image; The single-layer resistance factor calculation submodule is configured to determine the single-layer resistance factor of each travel blocking region based on the stenosis rate, length-diameter ratio, cross-sectional irregularity and surface roughness of each travel blocking region; The travel blocking region combination submodule is configured to divide all the travel blocking regions in the latest contrast image into a plurality of to-be-analyzed combined blocking region sets based on the spatial relationship between all the travel blocking regions; The combined resistance effect analysis submodule is configured to determine the single-layer travel resistance factor of each to-be-analyzed combined blocking region set, to perform combined resistance effect analysis on the single-layer resistance factors of all the travel blocking regions in each to-be-analyzed combined blocking region set, and to obtain second travel resistance factors of all the travel combined resistance factors.

6. The hydrophilic coated catheter of claim 5, wherein, The combined resistance effect analysis submodule includes: A travel combined resistance factor determination unit configured to determine a corresponding travel combined resistance factor based on the range and spatial relationship of the travel blocking regions in each to-be-analyzed combined blocking region set; A first combined resistance effect analysis unit configured to, when the spatial relationship between the travel blocking regions in the to-be-analyzed combined blocking region set is series blocking, calculate the second travel resistance factor of the corresponding travel combined resistance factor based on the single-layer resistance factors of all the travel blocking regions in the corresponding to-be-analyzed combined blocking region set and the axial distance between adjacent travel blocking regions; A second combined resistance effect analysis unit configured to, when the spatial relationship between the travel blocking regions in the to-be-analyzed combined blocking region set is parallel blocking, calculate the second travel resistance factor of the corresponding travel combined resistance factor based on the single-layer resistance factors of all the travel blocking regions in the corresponding to-be-analyzed combined blocking region set, the flow area reduction ratio and a correction factor of the angle between the catheter body travel direction and the main coordinate direction of the blood vessel geometry coordinate system; The third combined resistance effect analysis unit is configured to determine a blocking position coefficient of all the travel blocking regions in the set of combined blocking regions to be analyzed when a spatial relationship between the travel blocking regions in the set of combined blocking regions to be analyzed is a bifurcation blocking, and calculate a second travel resistance factor of the corresponding travel combined resistance factor based on the single-layer resistance factor of all the travel blocking regions in the set of combined blocking regions to be analyzed, the bifurcation angle coupling coefficient, the bifurcation angle, the branch number, and the blocking position coefficient of all the travel blocking regions.

7. The hydrophilic coated angiographic catheter of claim 1 wherein, The resistance development analysis module comprises: The resistance factor step-by-step combination analysis tree construction submodule is configured to construct a resistance factor step-by-step combination analysis tree based on all the travel combined resistance factors and the corresponding second travel resistance factors. The travel resistance combination analysis context generation submodule is configured to randomly combine the leaf relationships between adjacent levels in the resistance factor step-by-step combination analysis tree to obtain a plurality of travel resistance combination analysis contexts, wherein each travel resistance combination analysis context comprises any leaf relationship between adjacent levels. The travel resistance change curve fitting submodule is configured to take the level where each node included in each travel resistance combination analysis context is located as a horizontal coordinate value, take the corresponding travel resistance factor as a vertical coordinate value, determine the coordinate value of each node included in each travel resistance combination analysis context in a two-dimensional coordinate, and based on the order of all the nodes included in each travel resistance combination analysis context, smoothly fit the coordinate values of all the nodes included in the corresponding travel resistance combination analysis context in the two-dimensional coordinate to obtain a corresponding travel resistance change curve. The resistance development factor analysis submodule is configured to analyze a plurality of resistance development factors based on all the travel resistance change curves.

8. The hydrophilic coated catheter of claim 7, wherein, The resistance development factor analysis submodule comprises: The resistance curve feature analysis unit is configured to analyze the resistance change rate factor, the resistance amplitude factor, the resistance duration factor, the resistance frequency factor, and the resistance gradient factor of each travel resistance change curve. The resistance development factor synthesis unit is configured to perform weighted summation on the resistance change rate factor, the resistance amplitude factor, the resistance duration factor, the resistance frequency factor, and the resistance gradient factor of each travel resistance change curve to obtain a resistance development factor of each travel resistance change curve.

9. The hydrophilic coated angiographic catheter of claim 1 wherein, The lubricant release parameter determination module comprises: The model construction submodule is configured to construct a lubricant release amount calculation model based on an artificial intelligence algorithm. The release parameter determination submodule is configured to input the first travel resistance factors of all the basic travel resistance factors and all the resistance development factors into the lubricant release amount calculation model to obtain a lubricant release parameter in a future period. The control instruction output submodule is configured to output a lubricant release parameter control instruction based on the lubricant release parameter in the future period.

10. A lubricant smart release system for a hydrophilic coated angiographic catheter, characterized by, The lubricant release parameter control instruction is output by any of the hydrophilic coating angiographic catheters described in claims 1 to 9, and the lubricant intelligent release device is controlled based on the lubricant release parameter control instruction.

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