Hydrophilic coating angiographic catheter and intelligent lubricant release system thereof

By obtaining the contrast image sequence and real-time travel distance in front of the catheter, combining the analysis module to identify and build a resistance factor tree, scientifically control the release of lubricant, the problem that the existing contrast catheter cannot match the actual resistance is solved, and the smooth progress of the catheter and the improvement of the patient experience are achieved.

CN120437463AActive Publication Date: 2025-08-08DONGGUAN DIKAI MEDICAL
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Patent Information

Application Number
CN202510685274.7
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-05-27
Publication Date
2025-08-08
Estimated Expiration
2045-05-27

AI Technical Summary

Technical Problem

The existing angiographic catheters cannot fully understand the travel environment and status of the catheter in the body, and cannot accurately analyze the factors related to travel resistance, resulting in the release of lubricant that cannot match the actual resistance during the travel of the catheter, affecting the lubricating effect and patient experience of the catheter.

Method used

The data acquisition module obtains the continuous contrast image sequence and real-time travel distance in front of the catheter. Combined with the basic travel factor analysis module, the barrier area analysis module and the resistance factor analysis module, identify and analyze the vascular morphology and barrier area, build a resistance factor analysis tree, fit the resistance change curve, and scientifically and accurately control the release of lubricant.

Benefits of technology

It realizes the precise release of lubricant, improves the lubricating effect and patient experience of the catheter, ensures the smooth progress of the catheter, and improves the safety and comfort of interventional treatment.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention relates to the technical field of medical instruments, and particularly discloses a hydrophilic coating angiographic catheter and an intelligent lubricant release system thereof, and the hydrophilic coating angiographic catheter comprises a data acquisition module which is used for acquiring a continuous angiographic image sequence and a real-time advancing distance in front of the catheter; the basic advancing factor analysis module analyzes the blood vessel form based on the image to obtain a first advancing resistance factor of the basic advancing resistance factor; the blocking area analysis module identifies the advancing blocking area and determines the latest relative position and the three-dimensional size of the advancing blocking area; a combined resistance factor analysis module performs combined resistance effect analysis in combination with related data to obtain a traveling combined resistance factor and a second traveling resistance factor; the resistance development analysis module is used for constructing a resistance factor analysis tree, fitting a resistance change curve and analyzing a plurality of resistance development factors; the lubricant release parameter determination module outputs a lubricant release parameter control instruction based on the factors; the lubricant release is scientifically and accurately controlled, and the scientificity and effectiveness of catheter operation are improved.
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Description

Technical Field

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

[0002] In the field of interventional medicine, angiography is a commonly used diagnostic procedure. By injecting a contrast agent into specific locations within the body, imaging equipment is used to observe the morphology and function of the relevant organs or tissues. As a key instrument for angiography, the performance of angiography catheters directly impacts the examination results and patient experience. Traditional angiography catheters encounter frictional resistance when entering human blood vessels, which can not only cause patient discomfort but also damage the vessel lining, increasing the risk of complications. To reduce this frictional resistance, hydrophilic coating technology has been applied to angiography catheters. Upon contact with liquid, the hydrophilic coating absorbs water to form a lubricating film, reducing friction between the catheter and surrounding tissue. However, single hydrophilic coating technology has limitations, and its lubrication effect is difficult to dynamically adjust based on the actual conditions of the catheter's movement within the body. With the continuous advancement of medical technology, intelligent medical devices have become a key trend in the development of medical devices. The development of a system capable of intelligently releasing lubricants, combined with hydrophilic-coated angiography catheters, is of great significance. Such a system can sense the catheter's movement within the body in real time and precisely control the amount of lubricant released based on varying resistance conditions, further improving the catheter's lubrication performance, minimizing adverse effects on the patient's body, and enhancing the safety and comfort of angiography examinations. This not only helps improve the accuracy of diagnosis, but also promotes the development of interventional treatment technology in a more refined and humanized direction, and has broad application prospects in the fields of medical imaging diagnosis and interventional treatment.

[0003] However, existing angiographic catheter technology has numerous shortcomings, including the inability to fully understand the catheter's in-vivo environment and state. This inability to fully and accurately analyze factors related to travel resistance makes it difficult to precisely control lubricant release based on actual resistance. Consequently, lubricant release cannot be matched to the actual resistance during catheter travel, impacting catheter lubrication effectiveness and patient experience.

[0004] Therefore, the present invention provides a hydrophilic coating angiography catheter and a lubricant intelligent release system thereof. Summary of the Invention

[0005] The present invention provides a hydrophilic-coated angiography catheter and an intelligent lubricant release system thereof. A data acquisition module acquires a sequence of continuous angiography images and real-time travel distance in front of the catheter body, laying the foundation for subsequent analysis. A basic travel factor analysis module derives local vascular morphology data in front and a first travel resistance factor of the basic travel resistance factor based on the image sequence, thereby clarifying the basic resistance status. A blocking area analysis module identifies the travel blocking area in each angiography image and determines the relative position and three-dimensional size of the blocking area in the latest image in combination with the real-time travel distance, thereby accurately locating the blocking area. A combined resistance factor analysis module performs a combined resistance effect analysis based on local vascular morphology and blocking area information to obtain all combined travel resistance factors and a second travel resistance factor, thereby achieving a comprehensive assessment of the comprehensive resistance. A resistance development analysis module constructs an analysis tree using relevant factors and fits a resistance change curve to obtain a resistance development factor and predict the resistance development trend. A lubricant release parameter determination module outputs a lubricant release parameter control instruction based on the first travel resistance factor and the resistance development factor, thereby scientifically and accurately controlling the release of the lubricant. This ensures smooth catheter travel while rationally utilizing resources, thereby improving the scientificity and effectiveness of catheter operation, and enhancing the lubrication effect and patient experience of the catheter.

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

[0007] A data acquisition module, used to acquire a continuous angiographic image sequence in front of the catheter body and a real-time travel distance of the catheter body;

[0008] A basic moving factor analysis module is used to analyze the front local blood vessel morphology data based on the continuous angiography image sequence, and obtain the first moving resistance factor of all basic moving resistance factors from the front local blood vessel morphology data;

[0009] A blocking region analysis module is used to identify all travel blocking regions in each angiographic image in a continuous angiographic image sequence, and determine the latest relative position and three-dimensional size of each travel blocking region in the latest angiographic image in combination with the real-time travel distance of the catheter body;

[0010] A combined resistance factor analysis module is used to perform arbitrary combined resistance effect analysis on all travel-blocking areas in the latest angiography image based on the local vascular morphology data ahead and the latest relative positions and three-dimensional sizes of all travel-blocking areas in the latest angiography image, thereby obtaining all combined travel resistance factors and corresponding second travel resistance factors in the latest angiography image;

[0011] The resistance development analysis module is used to construct a resistance factor step-by-step combination analysis tree based on all combined travel resistance factors and the corresponding second travel resistance factors, fit multiple travel resistance change curves based on the resistance factor step-by-step combination analysis tree, and analyze multiple resistance development factors based on all travel resistance change curves;

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

[0013] Preferably, the data acquisition module includes:

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

[0015] The travel distance acquisition submodule 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 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 includes:

[0017] A vascular morphology reading submodule is used to analyze the anterior local vascular morphology data based on a continuous angiography image sequence;

[0018] The travel resistance factor judgment submodule is used to determine whether each dimensional morphological data in the local vascular morphological data in front meets the threshold data formed by the resistance factor of the corresponding dimension. If so, the corresponding basic travel resistance factor is determined, and the first travel resistance factor corresponding to the basic travel resistance factor is determined based on the part of the dimensional morphological data that exceeds the threshold data formed by the resistance factor of the corresponding dimension.

[0019] Preferably, the blocking area analysis module includes:

[0020] a blocking region analysis submodule, configured to identify all travel blocking regions in each angiography image in a sequence of continuous angiography images and generate a plurality of travel blocking region sequences;

[0021] The position and size analysis submodule is used to determine all inter-frame pixel displacement data of each travel-blocking area sequence, and combine it with the real-time travel distance of the catheter body to determine the latest relative position and three-dimensional size of each travel-blocking area in the latest angiographic image.

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

[0023] The vascular geometric coordinate system construction submodule is used to determine the centerline of the front local blood vessel based on the front local blood vessel morphology data, and to construct the vascular geometric coordinate system 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 centerline of the front local blood vessel as the main coordinate direction;

[0024] A positional relationship coordinate representation submodule is used to represent the latest relative position and three-dimensional size of all travel-blocking regions in the latest angiographic image using a vascular geometric coordinate system, obtain the axial position, radial position, and circumferential angle of each travel-blocking region in the latest angiographic image, and define the spatial relationship between all travel-blocking regions;

[0025] a resistance feature quantification submodule for determining the stenosis rate, aspect ratio, cross-sectional irregularity, surface roughness of each travel-blocking region, and the adjacent axial spacing between two adjacent travel-blocking regions based on the axial position, radial position, and circumferential angle of each travel-blocking region in the latest angiographic image;

[0026] A single-layer resistance factor calculation submodule is used to determine the single-layer resistance factor of each travel-blocking area based on the stenosis rate, aspect ratio, cross-sectional irregularity, and surface roughness of each travel-blocking area;

[0027] A travel-blocking region combining submodule is used to divide all travel-blocking regions in the latest angiographic image into a plurality of combined blocking region sets to be analyzed based on the spatial relationship between all travel-blocking regions;

[0028] The combined resistance effect analysis submodule is used to determine the single-level travel resistance factor of each combined blocking area set to be analyzed, perform combined resistance effect analysis on the single-layer resistance factors of all travel blocking areas in each combined blocking area set to be analyzed, and obtain the second travel resistance factor of all travel combined resistance factors.

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

[0030] a travel combination resistance factor determination unit, configured to determine a corresponding travel combination resistance factor based on the range and spatial relationship of the travel blocking areas in each set of combined blocking areas to be analyzed;

[0031] a first combined resistance effect analysis unit for calculating a second travel resistance factor corresponding to the combined travel resistance factor based on the single-layer resistance factors of all travel blocking areas in the combined blocking area set to be analyzed and the axial distances between adjacent travel blocking areas when the spatial relationship between the travel blocking areas in the combined blocking area set to be analyzed is a series blockage;

[0032] a second combined resistance effect analysis unit configured to calculate, when the spatial relationship between the travel blocking regions in the set of combined blocking regions to be analyzed is parallel blocking, a second travel resistance factor corresponding to the travel combined resistance factor based on the single layer resistance factors and flow area reduction ratios of all travel blocking regions in the set of combined blocking regions to be analyzed, and a correction factor for the angle between the travel direction of the catheter body and the main coordinate direction of the blood vessel geometric coordinate system;

[0033] The third combined resistance effect analysis unit is used to determine the blocking position coefficients of all the traveling blocking areas in the corresponding combined blocking area set to be analyzed when the spatial relationship between the traveling blocking areas in the combined blocking area set to be analyzed is bifurcation blocking, and calculate the second traveling resistance factor corresponding to the traveling combined resistance factor based on the single-layer resistance factors, bifurcation angle coupling coefficients, bifurcation angles, number of branches, and blocking position coefficients of all the traveling blocking areas in the corresponding combined blocking area set to be analyzed.

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

[0035] A 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 the corresponding second travel resistance factors;

[0036] The travel resistance combined analysis context generation submodule is used to gradually combine the resistance factors with any combination of leaf relationships between adjacent levels in the analysis tree to obtain multiple travel resistance combined analysis contexts, where each travel resistance combined analysis context contains any leaf relationship between all adjacent levels;

[0037] The resistance change curve fitting submodule is used to determine the coordinate value of each node in each resistance combined analysis context in two dimensions by taking the level of each node in each resistance combined analysis context as the horizontal coordinate value and the corresponding resistance factor as the vertical coordinate value. Based on the order of all nodes in each resistance combined analysis context, the coordinate values of all corresponding nodes in two dimensions are smoothly fitted to obtain the corresponding resistance change curve.

[0038] The resistance development factor analysis submodule is used to analyze multiple resistance development factors based on all travel resistance change curves.

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

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

[0041] The resistance development factor synthesis unit is used to perform weighted summation on the resistance change rate factor, resistance amplitude factor, resistance duration factor, resistance frequency factor, and 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 includes:

[0043] Model building submodule, used to build a lubricant release calculation model based on artificial intelligence algorithm;

[0044] A release parameter determination submodule is used to input 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;

[0045] The control instruction output submodule is used to output a lubricant release parameter control instruction based on the lubricant release parameter in a future time period.

[0046] The present invention provides a lubricant intelligent release system for a hydrophilic coating angiography catheter, which is used to receive a lubricant release parameter control instruction output from any hydrophilic coating angiography catheter of Examples 1 to 9, and control the lubricant intelligent release device based on the lubricant release parameter control instruction.

[0047] Compared with the prior art, the present invention has the following beneficial effects: a data acquisition module acquires a sequence of continuous angiographic images and real-time travel distance in front of the catheter body, laying the foundation for subsequent analysis; a basic travel factor analysis module derives the local vascular morphology data in front and the first travel resistance factor of the basic travel resistance factor based on the image sequence, clarifying the basic resistance status; a blocking area analysis module identifies the travel blocking area in each angiographic image and determines the relative position and three-dimensional size of the blocking area in the latest image in combination with the real-time travel distance, accurately locating the blocking area; a combined resistance factor analysis module performs a combined resistance effect analysis based on the local vascular morphology and blocking area information to obtain all combined travel resistance factors and the second travel resistance factor, comprehensively evaluating the comprehensive resistance; a resistance development analysis module constructs an analysis tree using relevant factors and fits the resistance change curve to obtain the resistance development factor and predict the resistance development trend; a lubricant release parameter determination module outputs a lubricant release parameter control instruction based on the first travel resistance factor and the resistance development factor, scientifically and accurately controlling the lubricant release, ensuring smooth catheter travel while rationally utilizing resources, improving the scientificity and effectiveness of catheter operation, and also improving the lubrication effect of the catheter and the patient experience.

[0048] Other features and advantages of the present invention will be described in the following description, and in part will become apparent from the description, or will be understood by practicing the present invention. The purpose and other advantages of the present invention can be achieved and obtained through the structures specifically pointed out in this application document.

[0049] The technical solution of the present invention is further described in detail below through the accompanying drawings and embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0050] The accompanying drawings are used to provide a further understanding of the present invention and constitute a part of the specification. Together with the embodiments of the present invention, they are used to explain the present invention and do not constitute a limitation of the present invention. In the accompanying drawings:

[0051] Figure 1 Schematic diagram of a hydrophilic coating angiography catheter and its lubricant intelligent release system in an embodiment of the present invention;

[0052] Figure 2 A schematic diagram of the execution logic of the submodules of the data acquisition module in an embodiment of the present invention;

[0053] Figure 3 A logic diagram is executed for the submodules of the basic travel factor analysis module in an embodiment of the present invention. DETAILED DESCRIPTION

[0054] The preferred embodiments of the present invention are described below with reference to the accompanying drawings. It should be understood that the preferred embodiments described herein are only used to illustrate and explain the present invention, and are not used to limit the present invention.

[0055] Example 1:

[0056] The present invention provides a hydrophilic coating angiography catheter, referring to Figure 1 ,include:

[0057] A data acquisition module, used to acquire a continuous angiographic image sequence in front of the catheter body and a real-time travel distance of the catheter body;

[0058] A basic moving factor analysis module is used to analyze the front local blood vessel morphology data based on the continuous angiography image sequence, and obtain the first moving resistance factor of all basic moving resistance factors from the front local blood vessel morphology data;

[0059] A blocking region analysis module is used to identify all travel blocking regions in each angiographic image in a continuous angiographic image sequence, and determine the latest relative position and three-dimensional size of each travel blocking region in the latest angiographic image in combination with the real-time travel distance of the catheter body;

[0060] A combined resistance factor analysis module is used to perform arbitrary combined resistance effect analysis on all travel-blocking areas in the latest angiography image based on the local vascular morphology data ahead and the latest relative positions and three-dimensional sizes of all travel-blocking areas in the latest angiography image, thereby obtaining all combined travel resistance factors and corresponding second travel resistance factors in the latest angiography image;

[0061] The resistance development analysis module is used to construct a resistance factor step-by-step combination analysis tree based on all combined travel resistance factors and the corresponding second travel resistance factors, fit multiple travel resistance change curves based on the resistance factor step-by-step combination analysis tree, and analyze multiple resistance development factors based on all travel resistance change curves;

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

[0063] In this embodiment, the continuous angiographic image sequence is generated by the angiography module using real-time X-ray angiography or fluoroscopy, and is a sequence of angiographic images of the vascular area in front of the catheter body collected at high frequency. These images can capture the dynamic changes of the blood vessels with high precision and high frequency.

[0064] In this embodiment, the real-time travel distance is determined by the travel distance acquisition submodule, which analyzes the inter-frame pixel displacement of the physical marker at the front end of the catheter body in the continuous angiographic image sequence to obtain the actual displacement of the catheter body between adjacent frames, thereby determining the real-time travel distance of the catheter.

[0065] In this embodiment, the local vascular morphology data ahead of the catheter is derived by the vascular morphology reading submodule within the basic motion factor analysis module based on analysis of continuous angiographic image sequences. It intuitively and critically presents the morphological characteristics of the local vessels ahead of the catheter, such as vessel diameter and tortuosity.

[0066] In this embodiment, the basic travel resistance factor refers to a factor related to the catheter's travel resistance determined when, within each dimension of the forward local vascular morphological data, a particular dimension of the morphological data satisfies the corresponding resistance factor threshold. For example, factors such as vascular tortuosity and caliber variation may serve as basic travel resistance factors.

[0067] In this embodiment, the first travel resistance factor is determined for each basic travel resistance factor based on the portion of the forward local vascular morphological data where the morphological data for that dimension exceeds the threshold data for the resistance factor for the corresponding dimension. This factor quantifies the impact of each basic travel resistance factor on the catheter's travel resistance. The numerical value reflects the strength of the corresponding basic travel resistance factor's effect on the catheter's travel, providing accurate and reliable data support for subsequent comprehensive assessment of the catheter's travel resistance within the vessel.

[0068] In this embodiment, the angiographic image is an image acquired by real-time X-ray angiography or fluoroscopy, and reflects the condition of the blood vessel area in front of the catheter body.

[0069] In this embodiment, the "obstructed area" refers to an area in each angiographic image of a continuous angiographic image sequence that is identified by the obstructed area analysis submodule as potentially obstructing the catheter's progress. Such an area may be a stenosis, plaque, branch, or other structure in a blood vessel.

[0070] In this embodiment, the latest relative position and three-dimensional dimensions of the travel-blocking region are determined by the position and dimension analysis submodule by analyzing the inter-frame pixel displacement data for each sequence of travel-blocking regions, combined with the real-time travel distance of the catheter body. The latest relative position specifies the spatial location of the travel-blocking region relative to the catheter body in the current and latest angiographic image, while the three-dimensional dimensions specifically describe the spatial size of the travel-blocking region, including information such as length, width, and height.

[0071] In this embodiment, the combined travel resistance factor is determined by combining the resistance factor analysis module with the resistance factor analysis module. This module analyzes the resistance effects of all travel-blocking regions based on the forward local vascular morphology data and the latest relative positions and three-dimensional dimensions of all travel-blocking regions in the latest angiographic image. This analysis then comprehensively considers various combinations of obstacles. For example, different travel-blocking regions may have different spatial relationships, such as series, parallel, or bifurcated. These combinations, collectively constituting the resistance factors affecting catheter advancement, constitute the combined travel resistance factor.

[0072] In this embodiment, the second travel resistance factor is derived by analyzing the combined resistance effect of each combined travel resistance factor on the individual resistance factors of all barrier regions within the corresponding combined barrier region set. This factor quantifies the impact of each combined travel resistance factor on the catheter's travel resistance, comprehensively considering multiple factors in different barrier region combinations. This factor more accurately reflects the actual travel resistance of the catheter in complex vascular environments, providing accurate data support for subsequent appropriate countermeasures.

[0073] In this embodiment, the resistance factors are gradually combined into an analysis tree: the resistance development analysis module is constructed based on all forward combined resistance factors and their corresponding second forward resistance factors. It organizes resistance information in a structured manner, hierarchically organizing different forward combined resistance factors and their corresponding resistance factors. This provides an organized framework for in-depth analysis of resistance development trends and facilitates a holistic understanding of the relationships and changing patterns among resistance factors.

[0074] In this embodiment, the travel resistance change curve: the travel resistance combined analysis context generation submodule gradually combines the resistance factors with the leaf relationships between adjacent levels in the analysis tree in any combination to obtain multiple travel resistance combined analysis contexts, and then the travel resistance change curve fitting submodule takes the level of each node in each context as the horizontal coordinate value and the corresponding travel resistance factor as the vertical coordinate value to determine the coordinate value of each node in the two-dimensional coordinate, and then these coordinate values are obtained by smooth fitting based on the node order.

[0075] In this embodiment, the resistance development factor (RDF) is derived by the resistance development factor analysis submodule based on an analysis of all resistance change curves. It is derived by weighted summation of the resistance change rate factor, resistance amplitude factor, resistance duration factor, resistance frequency factor, and resistance gradient factor of each resistance change curve. The RDF quantifies the development trend of resistance.

[0076] In this embodiment, the lubricant release parameter control instruction is generated by the lubricant release parameter determination module based on the first travel resistance factor and all resistance development factors of all basic travel resistance factors. This instruction is input into the lubricant release quantity calculation model to determine the lubricant release parameter for the future period. This instruction is then output by the control instruction output submodule. This instruction is used to control the intelligent lubricant release device.

[0077] Example 2:

[0078] Based on Example 1, the data acquisition module, refer to Figure 2 ,include:

[0079] An angiography module, configured to acquire an angiography image of the blood vessel region in front of the catheter body at a high frequency using a real-time X-ray angiography or fluoroscopy method and to form a continuous angiography image sequence;

[0080] The travel distance acquisition submodule 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 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 transmits X-rays through the human body and uses the difference in X-ray absorption or scattering characteristics between a contrast agent and surrounding tissues to capture vascular images in real time.

[0082] In this embodiment, fluoroscopy is also a medical imaging technique that uses X-rays to penetrate the human body, stimulating fluorescent substances to produce fluorescence, thereby displaying real-time images of the body's internal structures. In this system, this method, like real-time X-ray angiography, is used to acquire high-frequency angiographic images of the vascular area in front of the catheter body and form a continuous sequence.

[0083] In this embodiment, the physical marker at the front end of the catheter body is a specific marker located at the front end of the catheter body. It has unique imaging characteristics that allow it to be clearly identified in a series of continuous angiographic images. This physical marker serves as an important reference point for determining the position and displacement of the catheter. By tracking its position changes in different angiographic image frames, the catheter's progress can be analyzed. For example, this physical marker can be made of a special material that clearly contrasts with surrounding tissue under X-ray or fluoroscopic imaging, making it easy to accurately identify and locate 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 between two adjacent frames of angiography in a continuous sequence of angiography images. Since the continuous angiography images are continuously acquired at a certain frequency, the position change information of the catheter within a very short time interval is recorded between adjacent frames. By analyzing the difference in the pixel position of the physical marker in adjacent frames, that is, the inter-frame pixel displacement, the position change of the catheter within this extremely short time interval 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 the continuous imaging image sequence, the actual displacement of the catheter body between adjacent frames is analyzed and obtained: since the continuous imaging image sequence 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 frame images and combining it with 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, thereby obtaining the actual movement distance of the catheter body between adjacent frames. For example, if the actual length represented by each pixel in the imaging system is known to be 0.1 mm, if the pixel displacement of the physical marker between adjacent frames is measured to be 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, these actual displacements are accumulated to obtain the real-time travel distance of the catheter from the start to the current moment. For example, if 10 sets of actual displacement data between adjacent frames are obtained, with values of 1 mm, 1.2 mm, 0.8 mm, and so on, and these values are sequentially added together, the real-time travel distance of the catheter from the starting position to the current position can be obtained.

[0087] The beneficial effects of the above technology are as follows: the angiography module uses real-time X-ray angiography or fluoroscopy to collect angiography images of the vascular area in front of the catheter body at high frequency and form a continuous sequence. This enables the acquired images to capture dynamic changes in the blood vessels with high precision and frequency, providing a rich and accurate image data foundation for subsequent comprehensive and detailed analysis of the vascular conditions in front of the catheter, ensuring the timeliness and accuracy of the analysis. The travel distance acquisition submodule analyzes the actual displacement between adjacent frames based on the pixel displacement of the physical markers on the front of the catheter body between frames of the continuous angiography image sequence, and then determines the real-time travel distance. This image analysis-based method is clever and accurate, requiring no additional complex measuring equipment. It can accurately and real-timely obtain catheter travel distance information using existing image data. It is low-cost and closely related to the image data. It provides accurate position change data for subsequent operations such as analyzing catheter travel resistance in combination with vascular images, helping to improve the reliability and scientific nature of the entire system's monitoring and analysis of catheter travel status.

[0088] Example 3:

[0089] On the basis of Example 1, the basic travel factor analysis module, refer to Figure 3 ,include:

[0090] A vascular morphology reading submodule is used to analyze the anterior local vascular morphology data based on a continuous angiography image sequence;

[0091] The travel resistance factor judgment submodule is used to determine whether each dimensional morphological data in the local vascular morphological data in front meets the threshold data formed by the resistance factor of the corresponding dimension. If so, the corresponding basic travel resistance factor is determined, and the first travel resistance factor corresponding to the basic travel resistance factor is determined based on the part of the dimensional morphological data that exceeds the threshold data formed by the resistance factor of the corresponding dimension.

[0092] In this embodiment, each dimension of morphological data refers to specific data describing different aspects of the local vascular morphology in the front. Vascular morphology can be characterized from multiple dimensions, such as vessel diameter (radial dimension), vessel tortuosity (measured by indicators such as curvature, a spatial geometric dimension), and vessel wall smoothness (surface feature dimension). These specific data are each dimension of morphological data.

[0093] In this embodiment, resistance factor threshold data is defined as a standard value set for each dimension of the local vascular morphology data ahead to determine whether it constitutes a basic travel resistance factor. These threshold data are derived based on medical knowledge, clinical experience, and extensive experimental data. For example, for the dimension of vessel diameter, when the diameter is less than a certain value (i.e., the resistance factor threshold data), it may cause significant resistance to catheter advancement. This specific value is the resistance factor threshold data for that dimension.

[0094] In this embodiment, the resistance factor determination submodule within the basic travel factor analysis module determines whether each dimension of the local vascular morphology data meets the resistance factor threshold data for the corresponding dimension. The module compares the specific data for each dimension of the local vascular morphology data with the pre-set resistance factor threshold data for the corresponding dimension. For example, the module compares the actual vessel diameter with the resistance factor threshold data for the diameter dimension to determine whether the actual diameter is less than the threshold; or compares the actual vessel tortuosity index with the resistance factor threshold data for the tortuosity dimension. Through these comparisons, the module determines which dimensional vascular morphology will affect catheter travel.

[0095] In this embodiment, the corresponding basic travel resistance factor is determined: when the morphological data of a certain dimension meets the threshold data for the resistance factor of the corresponding dimension, the vascular morphological characteristics of that dimension are determined to constitute a basic travel resistance factor. For example, if the vessel diameter is less than the set threshold, "vessel diameter is too small" becomes a basic travel resistance factor; if the degree of vessel tortuosity exceeds the corresponding threshold, "vessel excessive tortuosity" will also be determined as a basic travel resistance factor.

[0096] In this embodiment, a first travel resistance factor corresponding to a basic travel resistance factor is determined based on the portion of the dimensional morphological data that exceeds the threshold data for the resistance factor of the corresponding dimension. For an already determined basic travel resistance factor, the portion of the dimensional morphological data that exceeds the threshold data for the resistance factor is further analyzed. For example, if the threshold data for the resistance factor of a vessel diameter is 5 mm, and the actual diameter is 3 mm, the portion exceeding the threshold is 2 mm. Based on this excess data, a specific calculation method (e.g., the ratio of the value of the excess portion to the threshold value) is used to determine the first travel resistance factor corresponding to the basic travel resistance factor (here, "vessel diameter is too small").

[0097] The beneficial effects of the above technology are as follows: The vascular morphology reading submodule accurately analyzes the forward local vascular morphology data based on the continuous angiography image sequence, providing intuitive and critical basic information for subsequent in-depth analysis of catheter travel resistance, allowing researchers to clearly understand the morphological characteristics of the vessels, such as diameter and degree of tortuosity. The travel resistance factor determination submodule scientifically determines the basic travel resistance factor and its first travel resistance factor by determining the relationship between the morphological data of each dimension of the forward local vascular morphology data and the threshold data of the corresponding dimensional resistance factors. This threshold-based judgment method enables more accurate identification and quantification of travel resistance factors, effectively distinguishing the degree to which different vascular morphologies affect catheter travel resistance, and providing accurate and reliable data support for subsequent comprehensive assessment of catheter travel resistance within the vessel. It helps to fully understand the basic resistance conditions encountered during catheter travel, thus providing a scientific basis for taking targeted measures to ensure smooth catheter travel, and improving the scientific and practical nature of the entire analysis process.

[0098] Example 4:

[0099] Based on Example 1, the blocking area analysis module includes:

[0100] a blocking region analysis submodule, configured to identify all travel blocking regions in each angiography image in a sequence of continuous angiography images and generate a plurality of travel blocking region sequences;

[0101] The position and size analysis submodule is used to determine all inter-frame pixel displacement data of each travel-blocking area sequence, and combine it with the real-time travel distance of the catheter body to determine the latest relative position and three-dimensional size of each travel-blocking area in the latest angiographic image.

[0102] In this embodiment, all travel-blocking regions in each angiography image in a sequence of continuous angiography images are identified, and multiple travel-blocking region sequences are generated:

[0103] The blocking region analysis submodule analyzes each image in the continuous angiographic image sequence. Using image processing techniques, such as image recognition algorithms, it identifies areas that could potentially hinder catheter advancement, known as blocking regions, based on differences in grayscale, texture, and other features across the angiographic image. For example, in an angiographic image, intravascular structures such as plaques, stenosis, and branching vessels may exhibit distinct characteristics from those of normal vascular regions, thus being identified as blocking regions.

[0104] For each identified travel-blocking region, its positional changes across frames are tracked as the image sequence progresses, generating multiple travel-blocking region sequences. Each sequence records the continuous changes of a specific travel-blocking region across consecutive angiographic images, facilitating analysis of the dynamic changes of that region over time and its relative relationship to catheter advancement. For example, the positional and morphological changes of a stenotic region in angiographic images at different times can be visualized through the corresponding travel-blocking region sequence.

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

[0106] For each sequence of movement-blocking regions, the inter-frame pixel displacement data is determined by analyzing the positional differences between the movement-blocking regions in adjacent frames within the sequence. This means measuring the change in pixel coordinates of each movement-blocking region between two adjacent frames to obtain its displacement information on the image plane. For example, if the upper-left corner pixel coordinates of a movement-blocking region are (x1, y1) in one frame and (x2, y2) in the next frame, the inter-frame pixel displacement is (x2-x1) in the x-direction and (y2-y1) in the y-direction.

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

[0108] Based on the converted actual displacement information, the most recent relative position of each travel-blocking region in the most recent angiographic image relative to the physical marker at the front end of the catheter body is determined. For example, the coordinate position of the travel-blocking region in three-dimensional space is determined using the physical marker at the front end of the catheter body as a reference point. Simultaneously, by analyzing the dimensional changes of the travel-blocking region between consecutive frames and combining it with the imaging system's principle of object size measurement, the three-dimensional dimensions of the travel-blocking region, such as length, width, and height, are determined.

[0109] The beneficial effects of the above technology are as follows: the obstruction region analysis submodule can identify all travel-blocking regions within each image in a continuous angiographic image sequence and generate multiple travel-blocking region sequences. This provides a systematic and comprehensive record of all obstructions encountered during catheter advancement, clearly displaying the distribution of travel-blocking regions at different times, and providing a complete data foundation for subsequent in-depth analysis. The position and size analysis submodule determines the inter-frame pixel displacement data for each travel-blocking region sequence and, combined with the real-time travel distance of the catheter itself, accurately determines the latest relative position and three-dimensional dimensions of each travel-blocking region in the latest angiographic image. This combination fully utilizes image sequence information and catheter movement information, enabling more accurate determination of the position and size of travel-blocking regions. This is crucial for determining the extent of the impact of travel-blocking regions on catheter advancement and provides precise data support for subsequent response strategy formulation and adjustment of catheter advancement plans.

[0110] Example 5:

[0111] Based on Example 1, combined with the resistance factor analysis module, it includes:

[0112] The vascular geometric coordinate system construction submodule is used to determine the centerline of the front local blood vessel based on the front local blood vessel morphology data, and to construct the vascular geometric coordinate system 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 centerline of the front local blood vessel as the main coordinate direction;

[0113] A positional relationship coordinate representation submodule is used to represent the latest relative position and three-dimensional size of all travel-blocking regions in the latest angiographic image using a vascular geometric coordinate system, obtain the axial position, radial position, and circumferential angle of each travel-blocking region in the latest angiographic image, and define the spatial relationship between all travel-blocking regions;

[0114] a resistance feature quantification submodule for determining the stenosis rate, aspect ratio, cross-sectional irregularity, surface roughness of each travel-blocking region, and the adjacent axial spacing between two adjacent travel-blocking regions based on the axial position, radial position, and circumferential angle of each travel-blocking region in the latest angiographic image;

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

[0116] A travel-blocking region combining submodule is used to divide all travel-blocking regions in the latest angiographic image into a plurality of combined blocking region sets to be analyzed based on the spatial relationship between all travel-blocking regions;

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

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

[0119] In this embodiment, the vascular geometric coordinate system is constructed using the current position of the physical marker at the front end of the catheter body as its origin and the extension direction of the local vascular centerline as its principal coordinate direction. This coordinate system is specifically designed for analyzing the position of catheters within blood vessels. It allows the position of various intravascular structures (such as travel-blocking areas) to be described within a unified coordinate framework, facilitating the quantification and analysis of various factors during catheter movement. Compared to general coordinate systems, it better reflects the actual conditions within blood vessels.

[0120] In this embodiment, the axial position, radial position, and circumferential angle of each travel-blocking region in the latest angiographic image are: In the vascular geometric coordinate system, the axial position represents the position of the travel-blocking region along the vessel centerline, reflecting its distribution along the vessel length; the radial position refers to the perpendicular distance between the travel-blocking region and the vessel centerline, reflecting its proximity to the center of the vessel cross section; and the circumferential angle represents the position of the region along the circumference of the vessel cross section, describing its orientation relative to a reference direction. These three parameters enable the precise determination of the spatial location of each travel-blocking region within the vessel.

[0121] In this embodiment, the spatial relationships between all travel-blocking regions are defined: Based on the axial position, radial position, and circumferential angle of each travel-blocking region in the vessel geometric coordinate system, their relative positions and distribution are analyzed to determine their spatial relationships. For example, different spatial arrangements can be determined, such as whether two travel-blocking regions are arranged in series (a serial relationship), side by side (a parallel relationship), or located at a vessel bifurcation.

[0122] In this embodiment, the stenosis rate, aspect ratio, cross-sectional irregularity, surface roughness of each travel-blocking region, and the adjacent axial spacing 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 angiographic image:

[0123] Stenosis rate: The reduction ratio of the cross-sectional area of the blood vessels in this area relative to the cross-sectional area of the normal blood vessels is calculated by using information such as the radial position of the blocked area, reflecting the degree of stenosis of the blood vessels.

[0124] Length-to-diameter ratio: The length of the travel-blocking region along the vascular axis is determined in combination with the axial position. Compared with the radial dimension of the region, the length-to-diameter ratio is obtained to evaluate the effect of the shape characteristics of the blocking region on the resistance.

[0125] Cross-sectional irregularity: The cross-sectional irregularity is determined based on the complexity of the shape of the blocked area on the cross-section of the blood vessel (comprehensively judged by information such as the circumferential angle and radial position). It reflects the degree to which its cross-sectional shape deviates from a regular circle. The higher the irregularity, the greater the interference with blood flow and catheter movement.

[0126] Surface roughness: Surface roughness is determined by analyzing the texture characteristics of the surface of the blocked area in the angiography image (compared with the surrounding normal blood vessel wall). It reflects the smoothness of the surface and affects the friction between the catheter and the surface of the blocked area.

[0127] Adjacent axial spacing: For two adjacent travel-blocking regions, the distance in the axial direction of the blood vessel is calculated based on their axial positions. This spacing affects the superposition of multiple travel-blocking regions on the catheter's travel resistance.

[0128] In this embodiment, the single-layer resistance factor of each travel-blocking region is determined based on its stenosis rate, length-to-diameter ratio, cross-sectional irregularity, and surface roughness. Using these quantified characteristic parameters, a specific mathematical model or empirical formula is used to comprehensively calculate a quantitative indicator of the resistance to catheter travel imposed by each travel-blocking region, namely the single-layer resistance factor. This factor reflects the degree of resistance to catheter travel imposed by a single travel-blocking region due to its own geometric shape, surface characteristics, and other factors. The specific mathematical model or empirical formula is as follows:

[0129]

[0130] Wherein, the single-layer resistance factor of a single travel-blocking area, α, β, and γ are weight coefficients (constants calibrated by experimental or clinical data, used to quantify the contribution ratio of different resistance factors), ΔD is the change in vessel diameter caused by the travel-blocking area (such as the reduction in the diameter of the stenotic segment, unit: mm), D0 is the original vessel diameter upstream of the travel-blocking area (the diameter of the normal unobstructed vessel, unit: mm), and L is the axial length of the travel-blocking area (such as the length of the stenotic segment or plaque, unit: mm).

[0131] In this embodiment, the single layer resistance factor of the travel blocking region is a value that quantifies the degree of obstruction of the catheter by a single travel blocking region. A larger value indicates a greater resistance of the region to the catheter's travel.

[0132] In this embodiment, based on the spatial relationship between all travel-blocking areas, all travel-blocking areas in the latest angiography image are divided into multiple sets of combined blocking areas to be analyzed: according to the spatial relationship between the travel-blocking areas defined previously, such as series, parallel, bifurcation, etc., the travel-blocking areas with similar spatial relationships are grouped together to form multiple sets of combined blocking areas to be analyzed.

[0133] The beneficial effects of the above technology are as follows: The vascular geometric coordinate system construction submodule determines the centerline based on the forward local vascular morphological data and constructs a coordinate system with the physical marker position at the front end of the catheter body as the origin. This provides a unified and targeted spatial reference system for subsequent analysis, making the description of the location and relationship of the travel-blocking regions more accurate and intuitive, and facilitating the implementation of subsequent analyses based on the same standard. The positional relationship coordinate representation submodule represents the location and dimensions of the travel-blocking regions using this coordinate system, clearly defining the axial, radial position, and circumferential angle of each travel-blocking region and defining its spatial relationship. This facilitates a deeper understanding of the spatial distribution characteristics of different travel-blocking regions within the vessel and lays the foundation for accurately assessing their combined impact. The resistance characteristic quantification submodule quantifies the resistance characteristics of the travel-blocking regions from multiple dimensions by determining multiple key indicators such as stenosis rate and length-to-diameter ratio. This provides a more detailed description of the resistance characteristics of each travel-blocking region and improves the accuracy of the analysis. The single-layer resistance factor calculation submodule determines the single-layer resistance factor based on these quantitative indicators, achieving a preliminary quantification of the resistance of individual travel-blocking regions and providing basic data for subsequent combined analysis. The Propulsion Blockage Area Combination submodule divides the set of combined barrier areas for analysis based on spatial relationships, taking into account the potential synergistic effects of different barrier area combinations and better aligning with the complex vascular environment. The Combined Resistance Effect Analysis submodule analyzes the combined resistance effects of each set to derive a second resistance factor for all combined resistance factors. This comprehensive consideration of the resistance under various combinations of factors allows for a more realistic reflection of the actual catheter travel resistance in complex vascular environments.

[0134] Example 6:

[0135] Based on Example 5, the resistance effect analysis submodule is combined, including:

[0136] a travel combination resistance factor determination unit, configured to determine a corresponding travel combination resistance factor based on the range and spatial relationship of the travel blocking areas in each set of combined blocking areas to be analyzed;

[0137] a first combined resistance effect analysis unit for calculating a second travel resistance factor corresponding to the combined travel resistance factor based on the single-layer resistance factors of all travel blocking areas in the combined blocking area set to be analyzed and the axial distances between adjacent travel blocking areas when the spatial relationship between the travel blocking areas in the combined blocking area set to be analyzed is a series blockage;

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

[0139] The third combined resistance effect analysis unit is used to determine the blocking position coefficients of all the traveling blocking areas in the corresponding combined blocking area set to be analyzed when the spatial relationship between the traveling blocking areas in the combined blocking area set to be analyzed is bifurcation blocking, and calculate the second traveling resistance factor corresponding to the traveling combined resistance factor based on the single-layer resistance factors, bifurcation angle coupling coefficients, bifurcation angles, number of branches, and blocking position coefficients of all the traveling blocking areas in the corresponding combined blocking area set to be analyzed.

[0140] In this embodiment, the corresponding combined travel resistance factor is determined based on the range and spatial relationship of the travel blocking areas in each set of combined blocking areas to be analyzed. For example, the combined travel resistance factor is the combined resistance factor of the series travel blocking areas in area A.

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

[0142]

[0143] Where R 总1 is the second travel resistance factor corresponding to the combined travel resistance factor when the spatial relationship between the travel blocking areas in the combined blocking area set to be analyzed is a series blockage, R 11 ,R 12 ,……,R 1n is the single-layer resistance factor corresponding to the 1st to nth moving blocking areas in the set of combined blocking areas to be analyzed, δ is the spacing coupling coefficient (a constant used to quantify the turbulence coupling resistance increment caused by the close spacing between adjacent blocking areas, with a value ranging from 0.1 to 0.8), ΔL ijis the axial distance between the i-th and j-th adjacent blocking areas (unit: mm, needs to be normalized to D0 or directly use the physical distance).

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

[0145]

[0146] Where R 总2 is the second travel resistance factor corresponding to the combined travel resistance factor when the spatial relationship between the travel blocking areas in the set of combined blocking areas to be analyzed is parallel blocking, R 21 ,R 22 ,……,R 2n are the single-layer resistance factors corresponding to the 1st to nth travel blocking areas in the set of combined blocking areas to be analyzed, η1, η2, ..., η n is the flow area reduction ratio at the locations of the 1st to nth travel blocking areas, It is the correction factor for the angle between the direction of travel of the catheter body and the main coordinate direction of the blood vessel geometric coordinate system. The value range is 1 to 1.2. When the angle is 0 degrees or 180 degrees, it is 1, and when it is 90 degrees, it is 1.2.

[0147] In this embodiment, the blocking position coefficients of all the travel blocking areas in the corresponding combined blocking area set to be analyzed are determined, namely: when the travel blocking area is located at the proximal end of the main branch, the blocking position coefficient λ=1; when the travel blocking area is located at the branch opening, the blocking position coefficient λ=0.5; when the travel blocking area 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 factors, bifurcation angle coupling coefficients, bifurcation angles, number of branches, and blocking position coefficients of all travel blocking areas in the set of combined blocking areas to be analyzed, a second travel resistance factor corresponding to the travel combined resistance factor is calculated, including:

[0149]

[0150] Where R 总3 is the second travel resistance factor corresponding to the combined travel resistance factor when the spatial relationship between the travel blocking areas in the set of combined blocking areas to be analyzed is bifurcation blocking, R 31 ,R 32 ,……,R 3nis the single-layer resistance factor of the 1st to nth travel blocking areas in the set of combined blocking areas to be analyzed, μ is the bifurcation angle coupling coefficient (through CFD simulation or clinical data fitting), cosθ is the cosine value of the bifurcation angle θ, k is the number of branches, m is the total number of travel blocking areas in the set of combined blocking areas to be analyzed, and λ j is the blocking position coefficient of the jth travel blocking area.

[0151] The above technology has the following beneficial effects: The combined resistance factor determination unit determines the combined resistance factor based on the range and spatial relationship of the obstruction area, accurately identifying resistance factors in different combinations, providing a clear definition for subsequent precise analysis and improving the targeted nature of the analysis. The first combined resistance effect analysis unit calculates the second resistance factor for series obstructions by comprehensively considering the single-layer resistance factor and the axial distance between adjacent areas. This fully accounts for the transfer and superposition characteristics of resistance in this type of obstruction, more accurately reflecting the impact of series obstructions on catheter travel resistance and providing precise data support for addressing such situations. The second combined resistance effect analysis unit calculates the resistance factor for parallel obstructions by combining the single-layer resistance factor, the flow area reduction ratio, and the angle correction factor. This comprehensively accounts for the key factors affecting resistance in parallel obstructions, effectively quantifies the travel resistance in parallel situations, and improves the accuracy of resistance analysis in complex vascular conditions. The third combined resistance effect analysis unit calculates the resistance factor for bifurcated obstructions by determining the obstruction position coefficient and combining multiple relevant parameters. This meticulously considers the impact of the unique geometric structure and mechanical properties of bifurcated obstructions on resistance, making resistance analysis in bifurcated obstruction areas more comprehensive and accurate.

[0152] Example 7:

[0153] Based on Example 1, the resistance development analysis module includes:

[0154] A 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 the corresponding second travel resistance factors;

[0155] The travel resistance combined analysis context generation submodule is used to gradually combine the resistance factors with any combination of leaf relationships between adjacent levels in the analysis tree to obtain multiple travel resistance combined analysis contexts, where each travel resistance combined analysis context contains any leaf relationship between all adjacent levels;

[0156] The resistance change curve fitting submodule is used to determine the coordinate value of each node in each resistance combined analysis context in two dimensions by taking the level of each node in each resistance combined analysis context as the horizontal coordinate value and the corresponding resistance factor as the vertical coordinate value. Based on the order of all nodes in each resistance combined analysis context, the coordinate values of all corresponding nodes in two dimensions are smoothly fitted to obtain the corresponding resistance change curve.

[0157] The resistance development factor analysis submodule is used to analyze multiple 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 combined travel resistance factors and the corresponding second travel resistance factors, namely:

[0159] Using combined travel resistance factors as nodes and the corresponding secondary travel resistance factors as attributes associated with each node, a tree structure is constructed according to certain logical relationships. This tree structure reflects the hierarchical relationship between different combined travel resistance factors and their combined impact on catheter travel resistance. For example, based on criteria such as the complexity of the resistance factor or its importance to the resistance, some basic, simple combined travel resistance factors may be assigned as lower-level nodes, while more complex resistance factors formed by combining these basic factors may be assigned as higher-level nodes.

[0160] The beneficial effects of the above technologies are as follows: the resistance factor is gradually combined with the analysis tree construction submodule to build an analysis tree with the forward combined resistance factor and the second forward resistance factor, structured and sorted out the resistance information, and laid an orderly framework for in-depth analysis; the forward resistance combined analysis context generation submodule generates multiple contexts by arbitrarily combining the leaf relationships of adjacent levels of the analysis tree, exploring resistance associations through multiple paths to avoid missing important information; the forward resistance change curve fitting submodule converts the context node information into two-dimensional coordinates and fits a curve, visually presenting the resistance change trend, facilitating rapid insight into characteristics; the resistance development factor analysis submodule extracts multiple resistance development factors based on the curve, and provides quantitative indicators for evaluating the resistance development trend; the overall module provides a comprehensive and scientific basis for catheter operation decisions from multiple aspects, helping operators to predict and respond to resistance changes and ensure smooth catheter movement.

[0161] Example 8:

[0162] Based on Example 7, the resistance development factor analysis submodule includes:

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

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

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

[0166] Resistance Change Rate Factor: This factor reflects how quickly the travel resistance changes over the course of the catheter's travel (or over time). It is determined by calculating the slope of the travel resistance curve at different points. A larger slope indicates a faster change in resistance during that period. For example, if the catheter's travel resistance increases rapidly over a period of time, the resistance change rate factor will be larger.

[0167] Resistance amplitude factor: refers to the maximum resistance value in the travel resistance change curve (or the maximum resistance value within a certain range). It reflects the maximum resistance that the catheter may encounter during its travel and is an important indicator for evaluating whether the catheter can successfully pass through certain areas.

[0168] Resistance Duration Factor: This factor indicates how long resistance persists at a specific level (or range). It helps determine the effects of prolonged exposure to a specific resistance level on the catheter and blood vessels. For example, prolonged exposure to high resistance may increase the risk of damage to the vessel wall or affect the accuracy of angiographic examinations.

[0169] The resistance frequency factor reflects how frequently resistance fluctuates during catheter advancement. This factor can be determined by counting the number of increases and decreases in the resistance curve. A higher resistance frequency factor indicates an unstable catheter environment, possibly involving complex vascular structures or pathology. This requires the system to more flexibly adjust lubricant release to account for these frequent resistance fluctuations.

[0170] Resistance Gradient Factor: This factor measures the steepness of resistance changes within a specific interval. Unlike the Resistance Rate of Change Factor, it focuses more on describing the abruptness of resistance changes within a relatively short interval. For example, if resistance rises or falls rapidly within a short distance in a certain region of the resistance curve, the resistance gradient factor in that region will be large, which may indicate that the catheter has encountered a unique vascular structure or obstruction, requiring special attention.

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

[0172] Considering the varying degrees of influence of different factors on resistance trends, each factor is assigned a corresponding weight. These weights may be determined based on medical knowledge, clinical experience, extensive experimental data, or optimized through machine learning algorithms. For example, if the resistance amplitude factor is more critical to catheter safety in a specific vascular environment or catheter operation scenario, then it will be given a relatively higher weight.

[0173] These five factors for each resistance curve are then multiplied by their respective weights and added together to produce a comprehensive value, the resistance development factor. This factor integrates multiple dimensions of resistance characteristics into a single quantitative indicator, comprehensively reflecting the resistance development trend represented by the curve. For example, for a resistance curve with a weight of 0.2 for the resistance change rate factor, 0.3 for the amplitude factor, 0.2 for the duration factor, 0.1 for the frequency factor, and 0.2 for the gradient factor, and assuming the values of these factors are 0.5, 0.8, 0.6, 0.4, and 0.7, respectively, then the resistance development factor = 0.2 × 0.5 + 0.3 × 0.8 + 0.2 × 0.6 + 0.1 × 0.4 + 0.2 × 0.7 = 0.64.

[0174] The beneficial effects of the above technology are as follows: the resistance curve characteristic analysis unit analyzes each travel resistance change curve from multiple dimensions to obtain the resistance change rate factor, resistance amplitude factor, resistance duration factor, resistance frequency factor, and resistance gradient factor. The resistance development factor synthesis unit performs a weighted summation of these factors in different dimensions to obtain the resistance development factor of each travel resistance change curve. This comprehensive approach comprehensively considers multiple key factors that affect resistance development, integrates complex multi-dimensional information into a single quantitative indicator, and makes the assessment of resistance development more concise and comprehensive. Through this comprehensive resistance development factor, operators can more intuitively and accurately grasp the overall development trend of resistance during the advancement of the catheter, provide a strong basis for formulating more scientific and reasonable catheter operation strategies, and significantly improve the depth and practicality of catheter resistance analysis.

[0175] Example 9:

[0176] Based on Example 1, the lubricant release parameter determination module includes:

[0177] Model building submodule, used to build a lubricant release calculation model based on artificial intelligence algorithm;

[0178] A release parameter determination submodule is used to input 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;

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

[0180] In this embodiment, a lubricant release calculation model is constructed based on an artificial intelligence algorithm, and data related to force and lubricant release, such as basic travel resistance factors, resistance development factors, actual resistance conditions under different vascular environments, and corresponding lubricant release amounts, are used. Utilizing these data, the algorithm automatically mines the complex relationships and patterns hidden in the data through deep learning, machine learning, and other technologies. For example, it analyzes how the blood vessel diameter, degree of curvature, and other basic travel resistance factors, together with the resistance development factors, affect the reasonable release amount of the lubricant. By 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 parameters such as the first travel resistance factor and the resistance development factor of the basic travel resistance factor. For example, based on a neural network algorithm, by continuously adjusting the weights and biases in the network, the output result of the model (lubricant release amount) is made as close to the actual demand as possible, 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 ml per minute in the next 5 minutes.

[0182] The beneficial effects of the above technology are as follows: the model construction submodule uses artificial intelligence algorithms to construct a lubricant release calculation model, fully leveraging the powerful data processing and analysis capabilities of artificial intelligence to accurately explore the complex internal relationships between basic travel resistance factors, resistance development factors, and lubricant release amount, providing strong model support for the subsequent precise determination of release parameters. The release parameter determination submodule inputs the first travel resistance factor and all resistance development factors of all basic travel resistance factors into the model, comprehensively considering the various factors affecting lubricant release, thereby deriving more accurate lubricant release parameters for the future time period. This ensures that the lubricant release amount closely matches the actual resistance conditions during catheter advancement, avoiding excessive or insufficient release and effectively improving lubricant utilization efficiency. The control instruction output submodule outputs control instructions based on the derived release parameters, achieving a seamless transition from parameter determination to actual control. It can timely and accurately regulate the lubricant release device to ensure lubricant release on demand in the future time period, providing reliable protection for the smooth advancement of the catheter in complex vascular environments and improving the overall safety and effectiveness of catheter operation.

[0183] Implementation 10:

[0184] The present invention provides a lubricant intelligent release system for a hydrophilic coating angiography catheter, which is used to receive a lubricant release parameter control instruction output from any hydrophilic coating angiography catheter of Examples 1 to 9, and control a lubricant intelligent release device based on the lubricant release parameter control instruction.

[0185] In this embodiment, the intelligent lubricant release device is the device responsible for actually executing the lubricant release operation within the hydrophilic-coated angiography catheter system. It receives lubricant release parameter control instructions from the hydrophilic-coated angiography catheter and precisely controls lubricant release based on these instructions. For example, the control instructions may specify specific parameters such as the release rate and amount of lubricant over a specific period of time. The intelligent lubricant release device, in accordance with these requirements, precisely releases lubricant to the contact area between the catheter and the blood vessel through its internal mechanical structure, electronic control system, and related drive components.

[0186] The beneficial effects of the above technology are: it can integrate the control instructions derived from various complex analyses under different embodiments, make full use of the results obtained in the early stage of resistance analysis, model building, etc., and provide a comprehensive and accurate basis for lubricant release control. The intelligent lubricant release device is controlled based on the received control instructions, which realizes the automated connection from data analysis to actual operation, greatly improving the accuracy and timeliness of lubricant release. It can accurately adjust the amount of lubricant released according to the real-time resistance conditions of the catheter moving in the blood vessel, avoiding the problem of unreasonable lubricant release caused by improper human operation or lag. This intelligent release system helps to improve the safety and stability of catheter operation. By precisely controlling the release of lubricant, it reduces the friction between the catheter and the blood vessel wall, reduces the risk of damage to the blood vessel, and ensures the smooth progress of medical operations.

[0187] Obviously, those skilled in the art may make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the present invention and its equivalents, the present invention is intended to include these modifications and variations.

Claims

1. A hydrophilic coating angiography catheter, characterized in that: include: A data acquisition module, used to acquire a continuous angiographic image sequence in front of the catheter body and a real-time travel distance of the catheter body; A basic moving factor analysis module is used to analyze the front local blood vessel morphology data based on the continuous angiography image sequence, and obtain the first moving resistance factor of all basic moving resistance factors from the front local blood vessel morphology data; A blocking region analysis module is used to identify all travel blocking regions in each angiographic image in a continuous angiographic image sequence, and determine the latest relative position and three-dimensional size of each travel blocking region in the latest angiographic image in combination with the real-time travel distance of the catheter body; A combined resistance factor analysis module is used to perform arbitrary combined resistance effect analysis on all travel-blocking areas in the latest angiography image based on the local vascular morphology data ahead and the latest relative positions and three-dimensional sizes of all travel-blocking areas in the latest angiography image, thereby obtaining all combined travel resistance factors and corresponding second travel resistance factors in the latest angiography image; The resistance development analysis module is used to construct a resistance factor step-by-step combination analysis tree based on all combined travel resistance factors and the corresponding second travel resistance factors, fit multiple travel resistance change curves based on the resistance factor step-by-step combination analysis tree, and analyze multiple resistance development factors based on all travel resistance change curves; The lubricant release parameter determination module is configured to output a lubricant release parameter control instruction based on a first travel resistance factor and all resistance development factors of all basic travel resistance factors.

2. The hydrophilic coating angiography catheter according to claim 1, characterized in that: Data acquisition module, including: An angiography module, configured to acquire an angiography image of the blood vessel region in front of the catheter body at a high frequency using a real-time X-ray angiography or fluoroscopy method and to form a continuous angiography image sequence; The travel distance acquisition submodule 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 travel distance of the catheter body based on the actual displacement of the catheter body between adjacent frames.

3. The hydrophilic coating angiography catheter according to claim 1, characterized in that: Basic travel factor analysis module, including: A vascular morphology reading submodule is used to analyze the anterior local vascular morphology data based on a continuous angiography image sequence; The travel resistance factor judgment submodule is used to determine whether each dimensional morphological data in the local vascular morphological data in front meets the threshold data formed by the resistance factor of the corresponding dimension. If so, the corresponding basic travel resistance factor is determined, and the first travel resistance factor corresponding to the basic travel resistance factor is determined based on the part of the dimensional morphological data that exceeds the threshold data formed by the resistance factor of the corresponding dimension.

4. The hydrophilic coating angiography catheter according to claim 1, characterized in that: Blocking area analysis module, including: a blocking region analysis submodule, configured to identify all travel blocking regions in each angiography image in a sequence of continuous angiography images and generate a plurality of travel blocking region sequences; The position and size analysis submodule is used to determine all inter-frame pixel displacement data of each travel-blocking area sequence, and combine it with the real-time travel distance of the catheter body to determine the latest relative position and three-dimensional size of each travel-blocking area in the latest angiographic image.

5. The hydrophilic coating angiography catheter according to claim 1, characterized in that: Combined with the resistance factor analysis module, including: The vascular geometric coordinate system construction submodule is used to determine the centerline of the front local blood vessel based on the front local blood vessel morphology data, and to construct the vascular geometric coordinate system 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 centerline of the front local blood vessel as the main coordinate direction; A positional relationship coordinate representation submodule is used to represent the latest relative position and three-dimensional size of all travel-blocking regions in the latest angiographic image using a vascular geometric coordinate system, obtain the axial position, radial position, and circumferential angle of each travel-blocking region in the latest angiographic image, and define the spatial relationship between all travel-blocking regions; a resistance feature quantification submodule for determining the stenosis rate, aspect ratio, cross-sectional irregularity, surface roughness of each travel-blocking region, and the adjacent axial spacing between two adjacent travel-blocking regions based on the axial position, radial position, and circumferential angle of each travel-blocking region in the latest angiographic image; A single-layer resistance factor calculation submodule is used to determine the single-layer resistance factor of each travel-blocking area based on the stenosis rate, aspect ratio, cross-sectional irregularity, and surface roughness of each travel-blocking area; A travel-blocking region combining submodule is used to divide all travel-blocking regions in the latest angiographic image into a plurality of combined blocking region sets to be analyzed based on the spatial relationship between all travel-blocking regions; The combined resistance effect analysis submodule is used to determine the single-level travel resistance factor of each combined blocking area set to be analyzed, perform combined resistance effect analysis on the single-layer resistance factors of all travel blocking areas in each combined blocking area set to be analyzed, and obtain the second travel resistance factor of all travel combined resistance factors.

6. The hydrophilic coating angiography catheter according to claim 5, characterized in that: Combined resistance effect analysis submodule, including: a travel combination resistance factor determination unit, configured to determine a corresponding travel combination resistance factor based on the range and spatial relationship of the travel blocking areas in each set of combined blocking areas to be analyzed; a first combined resistance effect analysis unit for calculating a second travel resistance factor corresponding to the combined travel resistance factor based on the single-layer resistance factors of all travel blocking areas in the combined blocking area set to be analyzed and the axial distances between adjacent travel blocking areas when the spatial relationship between the travel blocking areas in the combined blocking area set to be analyzed is a series blockage; a second combined resistance effect analysis unit configured to calculate, when the spatial relationship between the travel blocking regions in the set of combined blocking regions to be analyzed is parallel blocking, a second travel resistance factor corresponding to the travel combined resistance factor based on the single layer resistance factors and flow area reduction ratios of all travel blocking regions in the set of combined blocking regions to be analyzed, and a correction factor for the angle between the travel direction of the catheter body and the main coordinate direction of the blood vessel geometric coordinate system; The third combined resistance effect analysis unit is used to determine the blocking position coefficients of all the traveling blocking areas in the corresponding combined blocking area set to be analyzed when the spatial relationship between the traveling blocking areas in the combined blocking area set to be analyzed is bifurcation blocking, and calculate the second traveling resistance factor corresponding to the traveling combined resistance factor based on the single-layer resistance factors, bifurcation angle coupling coefficients, bifurcation angles, number of branches, and blocking position coefficients of all the traveling blocking areas in the corresponding combined blocking area set to be analyzed.

7. The hydrophilic coating angiography catheter according to claim 1, characterized in that: Resistance development analysis module, including: A 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 the corresponding second travel resistance factors; The travel resistance combined analysis context generation submodule is used to gradually combine the resistance factors with any combination of leaf relationships between adjacent levels in the analysis tree to obtain multiple travel resistance combined analysis contexts, where each travel resistance combined analysis context contains any leaf relationship between all adjacent levels; The resistance change curve fitting submodule is used to determine the coordinate value of each node in each resistance combined analysis context in two dimensions by taking the level of each node in each resistance combined analysis context as the horizontal coordinate value and the corresponding resistance factor as the vertical coordinate value. Based on the order of all nodes in each resistance combined analysis context, the coordinate values of all corresponding nodes in two dimensions are smoothly fitted to obtain the corresponding resistance change curve. The resistance development factor analysis submodule is used to analyze multiple resistance development factors based on all travel resistance change curves.

8. The hydrophilic coating angiography catheter according to claim 7, characterized in that: The resistance development factor analysis submodule includes: The resistance curve characteristic analysis unit is used to analyze the resistance change rate factor, resistance amplitude factor, resistance duration factor, resistance frequency factor, and resistance gradient factor of each travel resistance change curve; The resistance development factor synthesis unit is used to perform weighted summation on the resistance change rate factor, resistance amplitude factor, resistance duration factor, resistance frequency factor, and resistance gradient factor of each travel resistance change curve to obtain the resistance development factor of each travel resistance change curve.

9. The hydrophilic coating angiography catheter according to claim 1, characterized in that: Lubricant release parameter determination module, including: Model building submodule, used to build a lubricant release calculation model based on artificial intelligence algorithm; A release parameter determination submodule is used to input 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; The control instruction output submodule is used to output a lubricant release parameter control instruction based on the lubricant release parameter in a future time period.

10. A lubricant intelligent release system for a hydrophilic coating angiography catheter, characterized in that: Used to receive a lubricant release parameter control instruction output from any hydrophilic coating angiography catheter according to claims 1 to 9, and control the lubricant intelligent release device based on the lubricant release parameter control instruction.

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