Measurement system and measurement method for resistance index of flexible elongated guidewire, and operation application thereof

Abstract

Disclosed are a measurement system and measurement method for a resistance index of a flexible elongated guidewire, and an operation application thereof. The measurement system comprises a flexible elongated guidewire, a pattern, an image capture module, and a prompt module. The pattern is arranged on a proximal surface of the flexible elongated guidewire. The image capture module is provided with a channel allowing unobstructed passage of the flexible elongated guidewire, and the image capture module captures an image of the pattern in the channel. When an operator advances and rotates the flexible elongated guidewire into a circulatory system, the pattern is deformed due to the environmental resistance encountered by the flexible elongated guidewire within the circulatory system. The image capture module calculates a force situation of the flexible elongated guidewire according to the deformation of the pattern, so as to generate the resistance index. The prompt module is electrically connected to the image capture module to prompt the resistance index of the flexible elongated guidewire to the operator, thereby digitizing the tactile feedback experienced by the operator during operation of the flexible elongated guidewire.

Description

Flexible elongated guidewire resistance index measuring system, measuring method and its operation application TECHNICAL FIELD

[0001] The present invention relates to the field of flexible elongated medical devices, in particular to a flexible elongated guidewire resistance index measuring system, measuring method and its operation application. BACKGROUND

[0002] It is widely used in clinical medicine to insert a guidewire along the circulatory system to the lesion for treatment, such as renal dialysis catheter thrombus treatment and cardiac catheterization. When the guidewire is pushed along the circulatory system, even with the guidance of an X-ray machine, the size of the force is mostly determined by the experience and feel of the operator. Patent CN117897113A discloses a catheter robot and automatic navigation system, which discloses an algorithm that enables the operator to push the guidewire to the destination from the optimal path, but during the process of pushing the guidewire, the operator needs to carefully rotate and push the guidewire due to thrombus obstruction or the inherent curvature of the circulatory system. If the force is not careful, it may cause harm to the patient. Therefore, it is necessary and progressive to provide a standard or reference for the force during the placement of the guidewire.

[0003] The guidewire inserted into the human circulatory system will bear a resistance at the curved part of the circulatory system or due to the lesion causing the circulatory system to narrow, thrombus obstruction, etc. The operator needs to carefully rotate and push the guidewire, and when encountering the aforementioned resistance, the guidewire will deform, i.e. the strain described in material mechanics. According to Newton's third law of motion, the external force causing the distal end of the guidewire to bend will react on its proximal end due to the reaction force, causing the proximal end surface to deform. In addition, the operator feels the stress from the distal end, and the force applied to the guidewire to pass through the distal end obstacle, at this time the proximal end of the guidewire is subjected to the vector sum of the force from the distal end obstacle and the force applied by the operator at the proximal end, i.e. the net force of the guidewire. Based on the principle of mechanics, the present invention discloses an image and artificial intelligence method to convert the net force of the guidewire into a resistance index, which is provided to the operator as a reference for the force, so that the operator's feel in operating the flexible elongated guidewire is digitized. SUMMARY

[0004] The purpose of the present invention is to provide a flexible elongated guidewire resistance index measuring system, measuring method and its operation application, which converts the net force of the flexible elongated guidewire into a resistance index and provides it to the operator as a reference for the force, so that the operator's feel in operating the flexible elongated guidewire is digitized.

[0005] To achieve the above object, the present application provides a flexible elongated guide wire resistance index measuring system, the distal end of the flexible elongated guide wire is a free end in the circulatory system, the proximal end of the flexible elongated guide wire is an operating end outside the circulatory system, the operating end is held by an operator, the measuring system comprises:

[0006] a pattern, the pattern is arranged on the surface of the proximal end of the flexible elongated guide wire;

[0007] an image capturing module, the image capturing module is provided with a channel for the flexible elongated guide wire to pass through, the image capturing module captures the image of the pattern in the channel, when the operator holds the operating end of the flexible elongated guide wire and pushes and rotates the flexible elongated guide wire into the circulatory system, the pattern is deformed due to the environmental resistance in the circulatory system, the image capturing module calculates the stress condition of the flexible elongated guide wire according to the deformation amount of the pattern, and generates a resistance index;

[0008] a prompt module, the prompt module is electrically connected with the image capturing module to prompt the operator with the resistance index of the flexible elongated guide wire.

[0009] Further, the pattern is arranged on the surface of the proximal end of the flexible elongated guide wire, the pattern comprises a plurality of pattern units, each pattern unit corresponds to a specific position information; the position information comprises the length of the pattern unit from the distal end of the flexible elongated guide wire and the phase angle of the pattern unit in the visual angle of the outer ring of the proximal end cross section of the flexible elongated guide wire.

[0010] Further, the pattern unit comprises a landmark pattern representing the distance and a phase pattern representing the phase angle, the length of the pattern unit from the distal end of the flexible elongated guide wire is distinguished by the landmark pattern, and the phase angle of the pattern unit in the visual angle of the outer ring of the proximal end cross section of the flexible elongated guide wire is distinguished by the phase pattern.

[0011] Further, the pattern is generated by any one of printing, chemical etching, photo etching and sputtering, the pattern has a height protruding from the surface of the flexible elongated guide wire or a depth recessed in the surface of the flexible elongated guide wire.

[0012] Further, the image capturing module comprises the following arranged in the channel:

[0013] a light source;

[0014] a collimating mirror, the collimating mirror comprises at least one lens for converging the light source;

[0015] a reflecting mirror, the reflecting mirror reflects the light source converged by the collimating mirror on the pattern on the surface of the flexible elongated guide wire when the part of the flexible elongated guide wire with the pattern passes through the channel;

[0016] a light sensor for sensing the pattern-reflected light beam of the surface of the flexible elongated guide wire;

[0017] a processor electrically connected to the light source, the mirror and the light sensor to control the emission pulse of the light source and the deflection angle of the mirror, and to calculate the distance of the optical path by the time of the emission of the light source and the time of the signal of the pattern-reflected light received by the light sensor, and to calculate the position of each point of the pattern surface in the three-dimensional space by combining the distance of the optical path and the deflection angle of the mirror, and to form a point cloud file by collecting these points, the point cloud file containing the three-dimensional shape and position information of the pattern.

[0018] Further, the image capturing module further comprises a plurality of auxiliary mirrors, the auxiliary mirrors reflect the light source collected by the collimating mirror on the mirror, and the mirror reflects the light source on the pattern of the surface of the flexible elongated guide wire.

[0019] The application also provides a method for measuring the resistance index of a flexible elongated guide wire, the distal end of the flexible elongated guide wire is a free end in the circulatory system, and the proximal end is an operating end held by an operator outside the circulatory system; the proximal end surface of the flexible elongated guide wire is provided with a pattern, the pattern comprises a plurality of pattern units, each pattern unit corresponds to a position information, the position information comprises the length of the pattern unit from the distal end of the flexible elongated guide wire and the phase angle of the pattern unit in the visual angle of the outer ring of the proximal end cross section of the flexible elongated guide wire, and an image capturing module captures the pattern image of the surface of the flexible elongated guide wire and generates a point cloud file.

[0020] The measuring method comprises the following steps:

[0021] S1, modeling, operating in a simulated circulatory system simulating the actual circulatory system of a human body, comprising the following steps:

[0022] S1.1, establishing a background resistance point cloud file database:

[0023] In the case of no additional simulated resistance in the simulated circulatory system, i.e. in the case of background resistance, the operator inserts the distal end of the flexible elongated guide wire into the simulated circulatory system and pushes the proximal end of the flexible elongated guide wire at an arbitrary angle to the distal end to the terminal end of the simulated circulatory system, and the image capturing module reads the pattern on the surface of the flexible elongated guide wire to generate a background resistance point cloud file database;

[0024] S1.2, establishing a simulated resistance point cloud file database:

[0025] At any place in the simulation circulation system, any simulation resistance is applied, and the distal end of the flexible elongated guide wire encounters the simulation resistance. An operator operates a plurality of times at each case, and the flexible elongated guide wire is pushed to the distal end at any rotation angle, and the pattern on the surface of the flexible elongated guide wire is read by the image acquisition module to generate a simulation resistance point cloud file database;

[0026] S1.3, a reference displacement vector database is established:

[0027] The corresponding pattern units in the simulation resistance point cloud file database and the background resistance point cloud file database are compared, the displacement vector of the pattern unit under the simulation resistance is calculated, the reference displacement vector of the simulation resistance is calculated, the displacement vectors of a plurality of cases are calculated, and the reference displacement vector database is generated;

[0028] S2, actual application, including the following steps:

[0029] S2.1, an application point cloud file is established:

[0030] The distal end of the flexible elongated guide wire is placed in the actual circulation system of the human body or in the simulation circulation system with any simulation resistance. When the distal end of the flexible elongated guide wire encounters resistance, the operator pushes and rotates the flexible elongated guide wire to the distal end, and the image acquisition module reads the pattern on the surface of the flexible elongated guide wire to generate an application point cloud file;

[0031] S2.2, the resistance index is judged:

[0032] The position of the resistance is determined from the pattern unit in the application point cloud file, and compared with the corresponding pattern unit in the background resistance point cloud file database. The application displacement vector of the pattern unit is calculated, and the application displacement vector is compared with the corresponding reference displacement vector in the reference displacement vector database. The weight of the application displacement vector in the reference displacement vector distribution interval is calculated in the form of numerical difference, and the weight is the resistance index actually applied by the flexible elongated guide wire.

[0033] Further, in step S1.3, the image of the simulation resistance point cloud file is processed by image recognition, and the resistance index is judged by machine learning. The position information of the pattern unit and the size of the simulation resistance are used as the labels for machine learning, and a reference displacement vector database is established. In the actual application of step S2.2, the application point cloud file is input, and the resistance index actually applied is obtained by machine operation.

[0034] Further, in step S1.3, the reference displacement vector in the database is obtained by the case operation number, and the average value and standard deviation of the reference displacement vector at the corresponding resistance of the case are calculated by a statistical model of Gaussian distribution, and the average value of the reference displacement vector plus or minus three times the standard deviation is the upper and lower critical value of the resistance index of the flexible elongated guide wire at the resistance, and in step S2.2, if the application displacement vector at the resistance is calculated to be out of the critical value range of the resistance index, a prompt module is used to warn the operator.

[0035] Further, in step S2.2, the statistical process control method is used, the image acquisition module continuously reads the application point cloud file and calculates the application displacement vector, and if the probability of the continuously obtained application displacement vector falling outside the Gaussian distribution is increased, a prompt module is used to warn the operator.

[0036] Further, the image acquisition module acquires images in the form of an image sensor or an optical sensor.

[0037] The application also provides an operation application of a flexible elongated guide wire resistance index measurement method, which is performed according to the above measurement method, and is characterized in that: in the modeling step of step S1, the construction of the reference displacement vector database is completed by a specific expert operator, so that in the actual application of step S2, the general operator uses the operation method of the expert operator as a learning specification and reference to complete the insertion operation of the flexible elongated guide wire.

[0038] The application also provides another operation application of a flexible elongated guide wire resistance index measurement method, which is performed according to the above measurement method, and the simulation resistance in the simulation circulation system includes the content of personnel training teaching materials, the experience of clinical medical treatment or the cases recorded in real-time circulation system imaging.

[0039] After the above scheme is adopted, the application has the following beneficial effects:

[0040] The application sets a pattern on the proximal end surface of the flexible elongated guide wire, when the operator operates the flexible elongated guide wire to advance and rotate in the circulation system, the pattern on the proximal end surface will be deformed when the distal end of the flexible elongated guide wire encounters environmental resistance, according to the stress effect of the material, the deformation amount of the pattern can be calculated to obtain the stress condition of the flexible elongated guide wire, and a resistance index is generated, the resistance index can reflect the force state of the operator; the pattern image is acquired and the resistance index is calculated by an image acquisition module, and then the resistance index is prompted to the operator as a force reference by a prompt module.

[0041] The measurement system of the application has the following application effects:

[0042] 1、First, a simulation circulation system is constructed, and the force state of the flexible elongated guide wire when encountering a specific simulation resistance is calculated by the simulation circulation system as a subsequent force reference, which includes a critical value range of a resistance index, an average advancing distance, and an average rotation angle, etc. through the specific resistance. Subsequently, the operation method is trained or learned in the simulation circulation system, or in the actual operation application in the human circulation system. When the flexible elongated guide wire encounters resistance, the application displacement vector of the pattern is calculated, the application resistance index is obtained, and whether the application displacement vector exceeds the critical value range of the resistance index or whether the force state of the operator has a trend of exceeding the critical value range of the resistance index can be judged through the application resistance index. If so, the warning will be issued by the prompt module, and the current application resistance index and the force information such as the average advancing distance and the average rotation angle are displayed for the operator to refer to, so that the operator can adjust the force state in time to smoothly pass through the environmental resistance, and thus the digitalization of the feeling of the operator operating the flexible elongated guide wire is realized.

[0043] 2、The flexible elongated guide wire can be first operated by a specific expert operator in the simulation circulation system to complete the force reference when the flexible elongated guide wire encounters a specific resistance. The expert operator has rich operation experience and operation technology, and the operation data of the expert operator can form an expert database. The ordinary operator can call the expert database as a prompt guide in actual operation, which is equivalent to the expert operator guiding the ordinary operator on site, and can achieve better operation effect. This service can be provided according to the user's demand, and has high economic value. In addition, the ordinary operator can also learn or train the operation method under the prompt guidance of the expert database by using the simulation circulation system, and improve the operation technology. BRIEF DESCRIPTION OF DRAWINGS

[0044] Fig. 1 is a simulation schematic diagram of the flexible elongated guide wire of the present application entering the coronary artery from the aorta;

[0045] Fig. 2 is an operation schematic diagram of the flexible elongated guide wire of the present application;

[0046] Fig. 3 is a top planar development diagram of the flexible elongated guide wire of the present application;

[0047] Fig. 4 is a proximal end sectional view of the flexible elongated guide wire of the present application;

[0048] Fig. 5 is a perspective view of a first pattern unit of the present application;

[0049] Fig. 6a and 6b are respectively a top view before and after deformation of the first pattern unit of the present application;

[0050] Fig. 7 is a structural schematic diagram of an image capturing module of an embodiment of the present application;

[0051] Fig. 8 is a structural schematic diagram of an image capturing module of another embodiment of the present application;

[0052] Figure 9 is a block diagram of the framework of the measuring system of the present application;

[0053] Figure 10 is a schematic diagram of the operation of the flexible elongated guide wire before entering the right coronary artery of the present application.

[0054] Explanation of reference numerals:

[0055] 10, flexible elongated guide wire; 11, distal end; 12, proximal end; 20, image acquisition module; 21, light source; 22, collimator; 23, mirror; 24, processor; 25, light sensor; 26, channel; 27, auxiliary mirror; 30, prompting module; 40, pattern; 41, first pattern unit; 411, first phase pattern; 42, second pattern unit; 421, second phase pattern; 43, third pattern unit; 44, fourth pattern unit; 45, first pattern element; 46, second pattern element; 47, third pattern element; 48, fourth pattern element; 50, cardiac catheter; 60, cardiovascular system; 61, aorta; 62, right coronary artery; 63, left coronary artery; 631, left anterior descending branch; 632, circumflex branch; 70, scanning frame. Embodiment of the present application

[0056] The present application is described in detail below with reference to the accompanying drawings and specific embodiments.

[0057] In the present application, the term "proximal end" refers to the end of the flexible elongated guide wire that is closer to the operator when placed in the human body, while the "distal end" refers to the end that is farther away from the operator. The "axial direction" refers to the length direction of the flexible elongated guide wire during transportation, and the "circumferential direction" refers to the direction that surrounds the central axis of the flexible elongated guide wire in a clockwise direction from the perspective of the proximal end. The "circulatory system" refers to the "human circulatory system" in clinical medicine, as well as an "analog circulatory system" that is constructed in a 1:1 ratio and has the same objective conditions as the human circulatory system. The analog circulatory system can adjust its three-dimensional size according to the simulation scenario, and can add simulated resistance at any point in the analog circulatory system.

[0058] As shown in Figures 1-10, the present application provides a measuring system for the resistance index of a flexible elongated guide wire, which is a medical device placed in the circulatory system. The distal end 11 of the flexible elongated guide wire 10 is the free-moving end that enters the circulatory system, and the proximal end 12 of the flexible elongated guide wire 10 is located outside the circulatory system, which is the operating end held by the operator.

[0059] In actual operation, the operator holds the operation end of the flexible elongated guide wire 10 and pushes the flexible elongated guide wire 10 into the circulatory system until reaching the target position. The flexible elongated guide wire 10 has important functions of guiding, orbiting, supporting and pushing in the medical intervention operation. However, in the process of pushing the flexible elongated guide wire 10, the environmental resistance in the circulatory system is encountered, and the operator needs to carefully push and rotate the flexible elongated guide wire 10, otherwise the human body will be damaged.

[0060] The environmental resistance in the circulatory system includes the bending of the circulatory system itself or the thrombus resistance, as shown in FIG. 1, taking the coronary artery in the cardiovascular 60 as an example, the distal end 11 of the flexible elongated guide wire 10 enters the coronary artery from the aorta 61, the flexible elongated guide wire 10 is the guide wire part in the cardiac catheter 50, which is sleeved in the center of the cardiac catheter 50, the distal end of the cardiac catheter 50 stays at the entrance of the coronary artery and does not advance any more, and the distal end 11 of the flexible elongated guide wire 10 enters the coronary artery. The coronary artery includes two branches of the right coronary artery 62 and the left coronary artery 63, and the left coronary artery 63 has two branches of the left anterior descending branch 631 and the circumflex branch 632, the flexible elongated guide wire 10 needs to turn when entering these branches of the coronary artery, which belongs to the bending resistance of the circulatory system itself, that is, the background resistance. In addition, the thrombus in the coronary artery causes the blood vessel to be narrow, which belongs to the lesion resistance, and the lesion resistance is simulated by the simulated resistance in the simulated circulatory system. When the flexible elongated guide wire 10 encounters the above environmental resistance, the distal end 11 thereof will be bent and deformed, according to Newton's third law of motion, the deformation of the distal end 11 of the flexible elongated guide wire 10 will be reflected on the proximal end 12 thereof, and the force state of the flexible elongated guide wire 10 can be calculated by measuring the deformation amount of the surface of the proximal end 12. It should be noted that the flexible elongated guide wire 10 of the present application can be applied not only in the cardiovascular 60, but also in the cerebral blood vessels and other circulatory systems such as the renal dissection tube.

[0061] The measuring system of the present application includes a pattern 40 arranged on the surface of the proximal end 12 of the flexible elongated guide wire 10, the pattern 40 is integrally arranged with the flexible elongated guide wire 10, when the flexible elongated guide wire 10 encounters the environmental resistance in the circulatory system, the proximal end 12 of the flexible elongated guide wire 10 will be bent, and the pattern 40 thereon will also be deformed, and the force state of the operator can be calculated by calculating the deformation amount of the pattern 40.

[0062] The measurement system of the present application further comprises an image acquisition module 20 and a prompt module 30, the image acquisition module 20 and the prompt module 30 are electrically connected, the image acquisition module 20 is provided with a channel, the proximal end 12 of the flexible elongated guide wire can pass through the channel 26 without any obstruction, and is held and operated by the operator. The action of the flexible elongated guide wire 10 is entirely generated by the force applied by the hands of the operator, and is not affected by the channel 26. When the operator holds the operating end of the flexible elongated guide wire 10 and pushes and rotates the flexible elongated guide wire 10 into the circulatory system, the pattern 40 is deformed due to the environmental resistance encountered by the flexible elongated guide wire 10 in the circulatory system, the shape of the pattern 40 before and after deformation is acquired by the image acquisition module 20 in the channel 26, then the deformation amount of the pattern 40 is calculated as the force applied by the operator, and a resistance index is generated; then the resistance index is displayed to the operator by the prompt module 30 for the operator to refer to, so that the operator digitizes the force applied to the flexible elongated guide wire 10.

[0063] Referring to FIGS. 3 and 4, the pattern 40 is located on the outer ring surface of the proximal end 12 of the flexible elongated guide wire 10, the pattern 40 comprises a plurality of pattern units, each pattern unit corresponds to a specific position information, for example, when the flexible elongated guide wire 10 encounters an environmental resistance, a specific pattern unit corresponding to the position of the encountered environmental resistance can be identified. The position information includes the length of the pattern unit from the distal end 11 of the flexible elongated guide wire, and the phase angle of the pattern unit located on the outer ring surface of the cross section of the proximal end 12 of the flexible elongated guide wire as the viewing angle, the phase angle represents the circumferential position on the outer ring surface of the proximal end 12 of the flexible elongated guide wire, for example, the top surface, left side surface, right side surface and bottom surface of the outer ring of the proximal end 12 of the flexible elongated guide wire, for example, at a position where an environmental resistance is encountered, a pattern unit at a position 111 cm from the top surface of the distal end 11 of the flexible elongated guide wire will be deformed.

[0064] Specifically, the pattern unit is composed of a plurality of three-dimensional pattern elements, and the advancing distance and the phase angle are taken as the reference of the geometric center of the pattern elements constituting the pattern unit, and any one or several of the different lengths, widths, diameters, edge lengths, heights and depths of the pattern elements are used to represent different position information, for example, in an embodiment, the pattern unit is composed of one pattern element, the height of the pattern element represents the phase angle information, and other geometric measurements of the pattern element represent the distance information, for example, the length, width and edge length represent the distance information.

[0065] In another preferred embodiment, the pattern unit is composed of a plurality of pattern elements, specifically, a landmark pattern and a phase pattern, the landmark pattern can be used to distinguish the length of the pattern unit from the distal end 11 of the flexible elongated guide wire, and the phase pattern can be used to distinguish the phase angle of the pattern unit from the viewing angle of the outer ring of the proximal end 12 of the flexible elongated guide wire. The pattern 40 is preferably composed of a plurality of pattern units arranged on the outer surface of the proximal end 11 of the flexible elongated guide wire. Since the lengths of the plurality of pattern units distributed circumferentially from the distal end 11 of the flexible elongated guide wire are the same, but each is distributed circumferentially at a different position on the outer surface of the proximal end 12, the landmark patterns of the circumferentially distributed pattern units are the same, and the phase patterns are different. Similarly, the landmark patterns of the axially distributed pattern units are different, and the phase patterns are the same.

[0066] Specifically, the landmark pattern can be composed of a plurality of three-dimensional pattern elements arranged in different lengths, widths, diameters, edge lengths, heights, and depths, and any one or more of the geometric dimensions of the pattern elements can be used to represent different distance information. The phase pattern can also be composed of a plurality of three-dimensional pattern elements, and the geometric dimensions of the pattern elements can be used to represent phase angle information. In a preferred embodiment, the phase pattern is composed of a pattern element, and the shapes of the pattern elements of different phase patterns are different, and different shapes of the pattern elements are used to represent different phase angle information.

[0067] The overall length of the flexible elongated guide wire 10 will also be adjusted accordingly due to the different heights of the human body. Therefore, different lengths of the flexible elongated guide wire 10 are required for operation, and the overall length specifications of the flexible elongated guide wire 10 are 150 cm, 160 cm, 170 cm, and the longest is more than 200 cm. Taking the flexible elongated guide wire 10 applied in the cardiovascular system 60 as an example, the setting position of the pattern 40 is set according to the starting position of entering the coronary artery, and the setting position of the pattern is fixed. The heart structure of different human bodies is different, and the starting position of entering the coronary artery will be different, so the flexible elongated guide wire 10 with a different pattern setting position is required. The pattern 40 is generally set at a position of 100 cm to 105 cm from the distal end 11 of the flexible elongated guide wire, and continues to be set in the proximal direction 12 along the axial direction. The same length of the flexible elongated guide wire has the same starting end of the pattern. From the start of entering the coronary artery, a position of about 20 cm in length will appear resistance, so the overall length of the pattern 40 set in the axial direction is about 20 cm.

[0068] Figure 3 is a top planar unfolded view of a flexible elongated guidewire 10 according to an embodiment of the present application, with a pattern 40 positioned to show part of the pattern units, including a first pattern unit 41, a second pattern unit 42, a third pattern unit 43, and a fourth pattern unit 44, the landmark pattern of each of these pattern units is composed of a plurality of cuboid pattern elements representing distance indicators, respectively a first pattern element 45, a second pattern element 46, a third pattern element 47, and a fourth pattern element 48, these pattern elements have different length or width dimensions, respectively corresponding to distance indicators of 1 cm, 2 cm, 5 cm, and 10 cm.

[0069] Taking the 100 cm from the distal end 11 of the flexible elongated guidewire 10 as the starting point of the pattern as an example, the landmark pattern of the first pattern unit 41 is composed of a first pattern element 45 and a fourth pattern element 48, then the length LI of the first pattern unit 41 from the distal end 11 of the flexible elongated guidewire is 111 cm, which is the sum of the starting position 100 cm, the 1 cm corresponding to the first pattern element 45, and the 10 cm corresponding to the fourth pattern element 48, i.e. LI = 100 (starting point) + 10 (fourth pattern element 48) + 1 (first pattern element 45) = 111 cm.

[0070] Similarly, the landmark pattern of the second pattern unit 42 is composed of two second pattern elements 46 and a third pattern element 47, corresponding to distance indicators of 2 cm, 2 cm, and 5 cm, then the length L2 of the second pattern unit 42 from the distal end 11 of the flexible elongated guidewire is 109 cm.

[0071] The landmark pattern of the third pattern unit 43 is composed of a first pattern element 46 and a second pattern element 47, corresponding to distance indicators of 1 cm and 2 cm, then the length L3 of the third pattern unit 43 from the distal end 11 of the flexible elongated guidewire is 103 cm.

[0072] The landmark pattern of the fourth pattern unit 44 is the same as that of the third pattern unit 43, and the length from the distal end of the flexible elongated guidewire is also 103 cm, but the phase patterns are different, the phase pattern of the third pattern unit 43 is a first phase pattern 411, the top view of which is circular, which can be a cylindrical pattern element; the phase pattern of the fourth pattern unit 44 is a second phase pattern 421, the top view of which is triangular, which can be a triangular prism pattern element, the first phase pattern 411 and the second phase pattern 421 represent different phase angles. In addition, the first pattern unit 41 and the third pattern unit 43 are on the same axial line, the phase pattern of the first pattern unit 41 is the same as that of the third pattern unit 43, the second pattern unit 42 and the fourth pattern unit 44 are on the same axial line, and the phase pattern of the second pattern unit 42 is the same as that of the fourth pattern unit 44.

[0073] The number of pattern units distributed circumferentially and axially on the outer surface of the proximal end 12 of the flexible elongated guide wire 10 can be set as needed, and the more the number of pattern units, the higher the accuracy of calculating the resistance index of the flexible elongated guide wire 10. For example, when six pattern units are evenly distributed circumferentially on the outer surface of the proximal end 12 of the flexible elongated guide wire 10, there are six phase patterns, and the included angle between adjacent two phase patterns is 60°. As shown in FIG. 4, in the present embodiment, the first phase pattern 411 is located at a position 335° from the vertex P of the cross-section outer ring of the proximal end 12 of the flexible elongated guide wire in the instantaneous clockwise direction (equivalent to a position 25° in the counterclockwise direction), that is, the first phase pattern 411 is the phase of the circumferential view 335° of the proximal end 12 of the flexible elongated guide wire, and the second phase pattern 421 is located at a position 60° from the vertex P in the clockwise direction, which is the phase of the circumferential view 60° of the proximal end 12.

[0074] FIG. 5 shows the three-dimensional shape of the first pattern unit 41, in which the first pattern element 45, the fourth pattern element 48 and the first phase pattern 411 have different heights. In the present embodiment, the size of each pattern element in the pattern unit is in the order of hundreds of micrometers (μm), for example, the length, width and height of the fourth pattern element 48 are 500 μm, 200 μm and 100 μm respectively, the length, width and height of the first pattern element 45 are 150 μm, 200 μm and 300 μm respectively, and the first phase pattern 411 is a cylindrical pattern element with a diameter of 200 μm and a height of 200 μm. In other embodiments, in addition to the length, width of the polygon and the diameter of the circle representing the position information, the height or depth can also be used to represent different position information, so that the length and width of one pattern element can be used to represent the distance information and the height to represent the phase angle information, so as to reduce the number of pattern elements and the area occupied, increase more pattern units and improve the precision of measurement. The pattern can be generated on the surface of the flexible elongated guide wire 10 by any one of printing, chemical etching, photo etching and sputtering, so that the pattern 40 has a height protruding from the surface of the flexible elongated guide wire 10, or a depth recessed in the surface of the flexible elongated guide wire 10.

[0075] Referring specifically to Figures 7 and 9, the image capturing module 20 includes a light source 21, a collimating lens 22, a reflecting mirror 23, a light sensor 25, and a processor 24 disposed within the channel 26. The collimating lens 22 includes at least one lens for focusing the light source 21. Taking the invisible light with a center wavelength of 940 nm as an example, the collimating lens 22 can focus the light emitted by the light source 21 into a diameter range of 10 μm. When the flexible elongated guide wire 10 with the pattern 40 passes through the channel 26, the reflecting mirror 23 reflects the light focused by the collimating lens 22 onto the pattern 40 on the surface of the flexible elongated guide wire 10. After the light is reflected onto the pattern 40 by the reflecting mirror 23, the light will be reflected again. The light sensor 25 is used to sense the light beam reflected again by the pattern 40. The processor 24 is electrically connected to the light source 21, the reflector 23, and the photosensor 25. The processor 24 can control the emission pulse of the light source 21, i.e., the emission time. Assuming the emission time of the light source 21 is t1, and the time between the photosensor 25 receiving the reflected signal from the pattern 40 is t2, the distance A between the photosensor 25 and the pattern 40 can be calculated from this time difference and the optical path distance. d =0.5×3×10 8 ×(t2-t1)m, the processor 24 can also control the deflection angle of the reflector 23 and generate the scanning deflection position of the reflector 23, such as the coordinates of point A (A x A y ) and distance A d Composition of coordinate elements (A) x A y A d The point cloud file is generated by the light source, which is emitted by the reflector 23 and received by the light sensor 25. Therefore, the optical path distance is twice the distance between the light sensor 25 and the pattern 40, resulting in a coefficient of 0.5.

[0076] As a preferred embodiment, the mirror 23 is a MEMS mirror, which is a miniature optical element integrating a micro motor, a mirror and a control circuit, and its working principle is based on electromagnetic force and mechanical movement. The rotation or swing of the mirror is driven by the micro motor to realize accurate control of the light path, so that the processor 24 is electrically connected with the mirror 23, and the deflection angle of the mirror 23 can control the scanning range of the image. Specifically, the mirror 23 provides a 20-degree wide and 40-degree long optical deflection area; the processor 24 controls the light source 21 in the deflection area, so that the light source 21 emits 640 times in 20-degree wide scanning time and emits 1280 times in 40-degree long scanning time. When the light source 21 is in the area of the first pattern unit 41, the heights of the fourth pattern element 48, the first pattern element 45 and the first phase pattern 411 are 100, 300 and 200 μm respectively, and the light sensor 25 receives the reflected light from the scanned first pattern element 45, first phase pattern 411 and fourth pattern element 48 in turn, and the distance of the light path is calculated by the processor 24, and one scanning frame 70 can constitute a 640 x 1280 point surface stereoscopic image; that is, the coordinate elements (A x , A y , A d ) in the aforementioned point cloud file, 1≤x≤640, 1≤y≤1280; the stereoscopic image is a stereoscopic angiogram of the horizontal cross section of the pattern 40 at a distance of 111 centimeters from the distal end 11 of the flexible elongated guide wire in the process of passing through the channel 26.

[0077] The point cloud file is a storage form of a mass of points expressing the spatial distribution and surface characteristics of the target in the same spatial reference system. These points usually contain three-dimensional coordinates in space, and the point cloud data in the point cloud file can be stored in various formats such as PCD, PLY, PTS and STL. The point cloud data in the point cloud file can be converted into a three-dimensional grid model through image processing technology of triangular mesh data conversion. In the subsequent operation steps of the measurement method, the point cloud data in the point cloud file is converted into a three-dimensional grid model through image processing technology, so as to obtain the three-dimensional shape and position information of the pattern, and to process the deformation of the three-dimensional coordinates of the pattern 40 when the flexible elongated guide wire 10 advances to the distal end 11.

[0078] With reference to FIG. 8, in an embodiment, the image capturing module 20 includes a plurality of auxiliary mirrors 27, which can reflect the light source collected by the collimating mirror 22 on the mirror 23, and then the mirror 23 reflects the light source on the pattern 40 on the surface of the flexible elongated guide wire 10. The auxiliary mirrors 27 can be flexibly arranged to adjust the positions of the light source 21 and the collimating mirror 22. For example, the light source 21 and the collimating mirror 22 can be arranged above the mirror 23, and the auxiliary mirrors 27 can be arranged beside the mirror 23. The flexible adjustment of the positions of the light source 21 and the collimating mirror 22 can reduce the occupied space of the image capturing module 20. The auxiliary mirrors 27 can be arranged as needed, which is not limited herein.

[0079] The application also provides a method for measuring the resistance index of a flexible elongated guide wire, which is performed by the measuring system and includes the following steps:

[0080] S1, modeling, constructing a model simulating the actual circulation system of a human body as a simulation circulation system, and calculating the force reference of the flexible elongated guide wire when encountering resistance at a specific position represented by each pattern unit through the simulation circulation system.

[0081] Please refer to FIG. 10, which takes the flexible elongated guide wire 10 entering the right coronary artery 62 as an example. When the flexible elongated guide wire 10 is at the aortic root 71, it is first rotated so that the distal end 11 has a better angle for entering the right coronary artery 62, and then it is pushed forward into the right coronary artery 62. During this process, in the absence of any lesion obstruction, the encountered environmental resistance inside the circulation system is the background resistance. In this embodiment, when the distal end 11 of the flexible elongated guide wire 10 enters the coronary artery, the distance from the operator end is about 100 centimeters, which is the starting position of the set of patterns 40, and the relevant point cloud file data is recorded. The starting position can be changed according to the needs of clinical application cases.

[0082] Specifically, the method includes the following steps:

[0083] S1.1, establishing a background resistance point cloud file database:

[0084] In the absence of added simulation resistance in the simulation circulation system, i.e. in the case of background resistance, the operator places the distal end 11 of the flexible elongated guide wire into the simulation circulation system, and pushes the proximal end 12 of the flexible elongated guide wire at an arbitrary angle to the distal end 11 to the terminal end of the simulation circulation system, i.e. the ends of the right coronary artery 62, the left anterior descending branch 631 and the left circumflex branch 632. The operator performs the operation several times, and simultaneously reads the pattern 40 on the surface of the proximal end 12 of the flexible elongated guide wire by using the image capturing module 20, and generates a background resistance point cloud file by using the processor 24. Further, FIG. 3 only shows four pattern units, and each pattern unit has only one phase pattern. In actual operation, several pattern units can be arranged according to the size of the pattern.

[0085] The processor 24 can set the sampling rate according to the specific requirements, such as taking 60 frames per second (i.e. 60 Hz). If the operator completes the first pattern unit 41 through the mechanism passage 26 in 2 seconds under the condition of background resistance, there will be 120 frames of recorded point cloud files. After several operations, the background resistance point cloud file data of the 111 cm from the distal end 11 of the flexible elongated guide wire is obtained. The 111 cm corresponds to the specific position of the distal end 11 of the flexible elongated guide wire in FIG. 2. Further, in different sizes of simulated circulation systems using different shapes of flexible elongated guide wires 10, the distal end of the right coronary artery 62, the left anterior descending branch 631 and the left circumflex branch 632 are all deeply inserted, and after several operations, any pattern unit will contain multiple sampling results, that is, the background resistance point cloud file database is completed, which contains operation data of different heights and different coronary artery branches.

[0086] S1.2, Establishing a simulated resistance point cloud file database:

[0087] In the case of adding a specific simulated resistance in the simulated circulation system, the operator places the flexible elongated guide wire 10 into the simulated circulation system, and at the proximal end 12 of the flexible elongated guide wire, the distal end 11 is pushed at an arbitrary angle to the added specific simulated resistance, and the operation is repeated several times. The specific simulated resistance, such as the smaller cross-sectional diameter of the right coronary artery 62 or the left anterior descending branch 631, is inserted into the simulated thrombus blocking material, and the specific simulated resistance is simulated according to the clinical experience and the actual circulation system angiography to obtain all possible existing resistance conditions of the circulation system, including the position of the resistance and the size of the resistance, which can achieve the effect of simulation. Each specific simulated resistance added corresponds to each simulated case, that is, a case. When the operator encounters a simulated resistance, the pushing and rotating force is increased to break through, and if it passes smoothly, it will return to the background resistance state.

[0088] According to the same principle of step S1.2, the image capture module 20 simultaneously reads the pattern 40 on the surface of the proximal end 12 of the flexible elongated guide wire, and the processor generates a simulated resistance point cloud file. The operator operates several times in each case, and the simulated resistance point cloud file database of each specific case is completed. If the simulated resistance placed is generally not broken through by the operator, further surgical methods such as balloon dilation must be used for operation, and the maximum force applied in this condition will be set as the maximum value of the applied force.

[0089] S1.3, Establishing a reference displacement vector database:

[0090] In the following description, the point cloud files have already completed the pre-processing steps of triangular mesh and image recognition. The rotation angle and the pushing distance are calculated by the image processing technology of triangular mesh data conversion, and are obtained by cooperating with the trajectory vector calculation of the pattern unit. In addition, the data calculation in the database can also use other calculation methods to obtain the displacement relationship of the pattern 40 between the simulated resistance and the background resistance, which can achieve the same effect.

[0091] The establishment of the reference displacement vector database specifically includes the following steps:

[0092] S1.3.1, respectively calculate the trajectory vector of the pattern unit in each operation in the background resistance point cloud file and the simulated resistance point cloud file:

[0093] In the multiple pattern acquisition under the background resistance:

[0094] The Nth pattern acquisition, the center of the frame is the first pattern unit 41, the position is 111 cm, 335 degrees;

[0095] The N+1th pattern acquisition, the recognized position of the center of the frame is 111 cm, 320 degrees;

[0096] The N+2th pattern acquisition, the recognized position of the center of the frame is 112 cm, 320 degrees;

[0097] The Mth pattern acquisition, the recognized position of the center of the frame is 111 cm, 60 degrees;

[0098] The M+1th pattern acquisition, the recognized position of the center of the frame is 111 cm, 46 degrees;

[0099] The M+2th pattern acquisition, the recognized position of the center of the frame is 111.4 cm, 46 degrees;

[0100] The M+3th pattern acquisition, the recognized position of the center of the frame is 112 cm, 46 degrees.

[0101] Therefore, the following is calculated:

[0102] The action from N to N+2 is to rotate clockwise by 15 degrees first, and then push forward by 1 cm;

[0103] The action from M to M+2 is to rotate clockwise by 14 degrees first, and then push forward by 0.4 cm;

[0104] The action from M to M+3 is to rotate clockwise by 14 degrees first, and then push forward by 1 cm;

[0105] Wherein, N, M represent the operation sequence number of completing one operation respectively; N+1, M+2…etc. are the frame sequence numbers captured by the processor 24 at the set sampling rate.

[0106] Obviously, at the center of the frame, the two operations are advanced from 111 cm to 112 cm, and the flexible elongated guide wire 10 rotates a clockwise rotation angle of 15 degrees and 14 degrees respectively. Since the sampling time of image capture is fixed, the M times of operation captures three patterns, which uses a relatively long time, but still advances the target distance.

[0107] When the flexible elongated guide wire distal end 11 encounters an applied simulated resistance at a distance of 111 cm from the distal end 11, the point cloud file captured by the image capture module 20 at the Lth time is identified, and the top view of the first pattern unit 41 after deformation is shown in FIG. 6B, and the multiple captures of the pattern are:

[0108] The Lth pattern capture, the center of the frame is the first pattern unit 41, the position is 111 cm, 335 degrees;

[0109] The L+1th pattern capture, the identified position of the center of the frame is 111 cm, 290 degrees;

[0110] The L+2th pattern capture, the identified position of the center of the frame is 112 cm, 290 degrees;

[0111] Therefore, it is calculated that:

[0112] The L to L+2 action is: first rotate clockwise by 45 degrees, and then advance 1 cm forward.

[0113] When the distal end 11 encounters a simulated resistance, the trajectory vector of the first pattern unit 41 in the point cloud file of the simulated resistance is compared with the trajectory vector of the same pattern unit in the background main force point cloud file, and there is a significant difference in the time required for the same distance or the rotation angle of the background main force point cloud file., then judge that the simulated resistance is encountered.

[0114] S1.3.2, calculate the reference displacement vector of each simulated resistance case:

[0115] Taking the position information of each pattern unit under the same index condition as the base point, the vector difference between the trajectory vectors of the simulated resistance point cloud file and the background resistance point cloud file at the base point position is calculated, which is the reference displacement vector at the position. The displacement vector is a three-dimensional displacement vector.

[0116] As in step S1.3.1, the Lth pattern extraction is the first pattern unit 41, the distance from the distal end 111 is 100 cm, and the phase angle is 335 degrees. The corresponding background resistance point cloud file is the Nth pattern extraction with the same phase angle. The Mth pattern extraction is not applicable due to the different phase angles. The frame at this position is identified and illustrated in FIGS. 6A and 6B, which are the top views of the first pattern unit 41 before and after deformation. In the figures, FIG. 6A is the Nth pattern extraction, and FIG. 6B is the Lth pattern extraction of the simulated resistance. The material of the flexible elongated guide wire 10 involved in the present application is a metal material, which can be restored after deformation caused by external force. Therefore, it is applicable to the Hooke's law in material mechanics. Within the elastic range of solid materials, the stress and strain are linearly related. Taking a landmark pattern and a pattern element as the base point, the pattern element and its adjacent pattern elements are the same solid material. The deformation of the pattern element and its adjacent pattern elements is the same deformation coefficient. Therefore, the displacement vector of the pattern unit can be calculated using any one pattern element of the pattern unit.

[0117] In this embodiment, the reference displacement vector is calculated based on the pattern element of the first phase pattern 411. In other embodiments, it can also be calculated based on any pattern element in the landmark pattern of the first pattern unit 41. As shown in FIGS. 6A and 6B, the X-axis deformation variable of the first phase pattern 411 is x1-x0. Similarly, it can be used for the Y-axis and Z-axis to calculate the single-axis deformation variable. After calculating the single-axis deformation variable, the size of the displacement vector of the first phase pattern 411 under the specific background resistance condition due to deformation is calculated as follows: 2 + (y1– y0) 2 + (z1– z0) 2 1 / 2 The direction is the direction of the vector sum of the components of the three mutually perpendicular axes. The size and direction of the displacement vector form the reference displacement vector.

[0118] Since the simulated resistance point cloud file is obtained through several operations, the force of the simulated resistance experienced by each operation has a size. As in step S1.2, in addition to the Lth operation, there are K and J operations that encounter resistance at the same position. In these operations, the center of the extracted pattern is the first pattern unit 41, but the force is slightly different. By obtaining the first phase pattern 411 of each first pattern unit 41 in each point cloud file, the reference displacement vector of each operation can be calculated as follows:

[0119] The Lth operation: displacement vector size 20 microns, axial force 110 degrees;

[0120] The Kth operation: displacement vector size 22 microns, axial force 115 degrees;

[0121] ​Jth time: displacement vector size 19.5 microns, axial force 108 degrees.

[0122] Mapping the trajectory vector of each operation in the simulation resistance point cloud file database to the corresponding associated trajectory of the background resistance point cloud file database, the reference displacement vector database when encountering the specific resistance is completed. Then, the statistical parameters of the reference displacement vector database are calculated by the Gaussian distribution model, including the mean and standard deviation of the reference displacement vector, which can quantify the stress state of the flexible elongated guide wire 10. The mean plus or minus three times the standard deviation of the reference displacement vector is the upper and lower critical value of the resistance index of the flexible elongated guide wire 10 under the specific simulation resistance. For example, if the mean of the displacement vector size is 21 microns and the standard deviation is 1 micron, it can be known that the operation data when encountering the specific resistance, the displacement vector of the operation will have a probability of 99.73% in the range of 18-24 microns.

[0123] S2, actual application, application scenarios include operators using simulation circulation systems to learn or train operation methods, and performing actual operations in actual human circulation systems. That is, in the training stage of the operator, the simulation circulation system can be used for operation training; or in clinical medical treatment, a similar reference displacement vector database is selected after coronary angiography, or a reference displacement vector database containing all cases is selected for operation as an auxiliary for the operator. Specifically, the following steps are included:

[0124] S2.1, establish application point cloud file:

[0125] The distal end 11 of the flexible elongated guide wire is placed in the actual circulation system of the human body or in the simulation circulation system with any simulation resistance. When the distal end 11 of the flexible elongated guide wire encounters resistance, the operator pushes and rotates the flexible elongated guide wire to the distal end 11, so that it passes through the channel 26 of the image capturing module 20 to the distal end, the image capturing module 20 reads the pattern 40 on the surface of the proximal end 12 of the flexible elongated guide wire, and generates an application point cloud file. The operation data of the application point cloud file can be collected into the application point cloud file database of the operation, which is used to reconstruct the operation process and serve as a reference for future improvement.

[0126] S2.2, interpret resistance index:

[0127] The processor 24 compares the trajectory vector of the pattern unit in the application point cloud file generated in real time with the trajectory vector of the same pattern unit of the corresponding background resistance point cloud file to determine whether the position subjected to resistance is reached. Once it is confirmed that resistance is encountered, the displacement vector of the pattern element of the corresponding pattern unit at the resistance position is calculated based on the relevant data of the reference displacement vector database associated with the resistance position. Specifically, the displacement vector of the pattern element in the corresponding pattern unit is the application displacement vector, which is compared with the corresponding reference displacement vector in the reference displacement vector database to calculate the weight of the application displacement vector in the reference displacement vector distribution interval in the form of numerical difference. The weight is the resistance index actually applied by the flexible elongated guide wire 10.

[0128] For example, if the size of the calculated application displacement vector is 19 microns, the resistance index is ((19-18) / (24-18)) x 100% = 16.7%, which represents the proportion of the application operation force applied in the critical range of the resistance index, and can reflect the current force state, including the distance of the advancement and the angle of the rotation. If the resistance index is within the range of 0 to 100%, it indicates that the force state of the current operation can pass through the resistance without damaging the circulatory system. If the maximum value of the force obtained in step S1.2 is 26 microns, once the size of the calculated displacement vector reaches 26 microns or the calculated resistance index approaches 100%, it indicates that further surgical methods must be used for operation, such as balloon dilation.

[0129] S2.3, statistical process control auxiliary application:

[0130] In the interpretation process of the resistance index, if the processor 24 determines that the application displacement vector exceeds the critical value range of the resistance index corresponding to the resistance obtained in step S1.3, i.e., exceeds the average value of the reference displacement vector of the pattern corresponding to the resistance plus or minus three times the standard deviation, the force of the operator is too large, and continuing to advance the flexible elongated guide wire 10 in this force state will not be able to pass through the resistance, and even damage the circulatory system. Therefore, the prompt module 30 will timely warn the operator and prompt the operator to adjust the force state in time to adjust the application resistance index within the critical value range of the resistance index to smoothly pass through the resistance.

[0131] Meanwhile, in the actual application of step S2, the processor 24 continuously obtains real-time point cloud files. In order to prevent the operator from being unable to adjust the force state in time, the present application uses a Gaussian distribution statistical model to timely prompt the operator to adjust the force state by using the statistical process control method. According to the Gaussian distribution curve, the principle is:

[0132] The probability of being distributed within the average value ± 1 times the standard deviation is 68.26%;

[0133] The probability of being distributed within the average value ± 2 times the standard deviation is 95.44%;

[0134] The probability of being distributed within the average value ± 3 times the standard deviation is 99.73%.

[0135] Because the probability of falling within the average value plus or minus one times the standard deviation to plus or minus three times the standard deviation is calculated as 99.73% - 68.26% = 31.47%, in terms of probability, if the distribution is very uniform, the maximum number of 3 points in the continuous sampling will only have 1 point in this region. Therefore, although the size of the displacement vector obtained continuously does not exceed the critical value range of the resistance index, if it exceeds the range of the average value plus or minus one times the standard deviation for several times, and the probability continues to rise, the application displacement vector read continuously has a trend of exceeding the critical value range of the resistance index, then the preferred control method is to remind the operator to pay attention through the prompt module 30 when the size of the displacement vector of the continuous 3 times exceeds the range of the average value plus or minus one times the standard deviation, that is, the application resistance index calculated by sampling 3 times continuously is greater than 68.26%, and continues to rise, in order to achieve the purpose of prevention, so that the operator has enough adjustment time. It should be noted that the way of issuing a warning when the size of the displacement vector is taken 3 times continuously exceeds the range of the average value plus or minus one times the standard deviation is only one of the control methods of "statistical process control", other control methods can also be used, for example, the displacement vector is taken 3 times continuously, and a warning is issued when two of them are not within the range of the average value plus or minus one times the standard deviation. Based on the Gaussian distribution curve, different control methods can be used.

[0136] In addition to warning reminders, the prompt module 30 can also display the application resistance index, as well as the average propulsion distance and average rotation angle calculated by the simulation resistance point cloud file database to provide reference information for the operator, so that the operator can operate the flexible elongated guide wire 10 to smoothly pass through the environmental resistance. Among them, the trajectory vector of each pattern unit operated several times in steps S1.1 and S1.2 can obtain the average propulsion distance and rotation angle of the flexible elongated guide wire 10 under the background resistance and the simulation resistance. The prompt module 30 can alert the operator in at least one of the following ways: text and image information on the screen, light, and sound.

[0137] The present application provides another point cloud file processing method, that is, after each frame point cloud file is identified, the simulated resistance and the specific position information of each pattern unit are added as labels to perform machine learning to establish a reference displacement vector database. For example, the size of the simulated resistance is divided into 100 levels: 1 is a small resistance, and 100 is an unprocessable resistance. At the same time, the position information of the simulated resistance is added, so that the image of the point cloud file can be applied to the TensorFlow system to perform the machine learning modeling. The purpose of the machine learning is to identify the relative position and displacement vector change of the relevant pattern in the point cloud file, identify the size level of the simulated resistance and the position thereof, and serve as a reference for subsequent actual application. In the actual application of step S2, the processor 24 can be modeled by the trained TensorFlow system, and after inputting the application point cloud file, the actual application resistance index can be obtained by machine operation, and the resistance index can be prompted by the prompting module 30.

[0138] The number of operations of steps S1.1 and S1.2 includes operations performed in different circulatory systems using flexible elongated guide wires 10 of different lengths or different shapes. The length of the flexible elongated guide wire 10 can be adjusted according to the height of the human body, and different interventional surgeries have different requirements for the shape of the flexible elongated guide wire 10. Therefore, the length and shape of the flexible elongated guide wire 10 have multiple types. In the process of obtaining the background resistance point cloud file and the simulated resistance point cloud file, the flexible elongated guide wire 10 of different lengths and different shapes needs to be operated multiple times, and each operation is recorded in the corresponding point cloud file. In the subsequent step S2, it can be applied to various operation scenarios.

[0139] In another embodiment, the image capturing module includes two or more cameras that generate a three-dimensional image of the surface pattern of the flexible elongated guide wire 10 from electronic imaging. The three-dimensional image is used to calculate the reference displacement vector in step S1.3 and the application displacement vector in step S2.2.

[0140] The application further provides an operation application of the flexible elongated guide wire resistance index measuring method, which is performed according to the above measuring method and includes, in the modeling step of step S1, constructing the reference displacement vector database by a specific expert operator, so as to complete the force reference when the flexible elongated guide wire 10 encounters resistance. The expert operator has rich operation experience and operation technology. The operation data of the expert operator can form an expert database. In the actual application of step S2, the ordinary operator can call the expert database as a reference in actual operation, which is equivalent to that the expert operator guides the ordinary operator on site, can achieve better operation effect, and can provide such service according to the user's demand. For example, in the case of tight resources of the expert operator, the ordinary operator can use the operation application to achieve better clinical medical effect, meet the user's demand, and has high economic value. In addition, the ordinary operator can also use the simulation circulation system to learn or train the operation method under the prompt guidance of the expert database, so as to improve the operation technology. The operation application has good training effect and can be widely used in teaching.

[0141] The application further provides another operation application of the flexible elongated guide wire resistance index measuring method. In the above measuring method, the simulation resistance in the simulation circulation system includes the content of personnel training teaching material, the experience of clinical medical treatment or the cases recorded by the real-time circulation system angiography.

[0142] It is worth noting that the flexible elongated guide wire 10 and the pattern shown in the drawings of the application are only examples and do not represent the real size. The real ratio between the flexible elongated guide wire 10 and the pattern 40 is also not as shown in the drawings, but only for reference.

[0143] The above is only the preferred embodiment of the application, and is not a limitation on the design of the application. Any equivalent changes made according to the key design of the application fall within the protection scope of the application.

Claims

1. A measurement system for the resistance index of a flexible, slender guidewire, wherein the distal end of the flexible, slender guidewire is a freely movable end that enters the circulatory system, and the proximal end of the flexible, slender guidewire is located outside the circulatory system and is a handheld operating end for the operator, characterized in that, The measurement system comprises: a pattern arranged on a proximal surface of the flexible elongated guide wire; an image capturing module having a channel for the flexible elongated guide wire to pass through without any obstruction, the image capturing module capturing images of the pattern in the channel, when an operator holds an operation end of the flexible elongated guide wire and pushes and rotates the flexible elongated guide wire into the circulatory system, the pattern deforms due to the environmental resistance in the circulatory system, the image capturing module calculates the force condition of the flexible elongated guide wire according to the deformation of the pattern, and generates a resistance index; a prompting module electrically connected with the image capturing module to prompt the operator with the resistance index of the flexible elongated guide wire.

2. A flexible elongated guidewire resistance index measuring system as recited in claim 1, wherein: The pattern is arranged on an outer ring surface of a proximal end of the flexible elongated guide wire, the pattern comprises a plurality of pattern units, each pattern unit corresponds to a specific position information, the position information comprises a length of the pattern unit from a distal end of the flexible elongated guide wire, and a phase angle of the pattern unit in a visual angle of an outer ring of a proximal end cross section of the flexible elongated guide wire.

3. A flexible elongated guidewire resistance index measuring system as recited in claim 2, wherein: The pattern unit comprises a landmark pattern representing the length and a phase pattern representing the phase angle, the length of the pattern unit from the distal end of the flexible elongated guide wire is distinguished by the landmark pattern, and the phase angle of the pattern unit in the visual angle of the outer ring of the proximal end cross section of the flexible elongated guide wire is distinguished by the phase pattern.

4. A flexible elongated guidewire resistance index measuring system according to any one of claims 1-3, wherein: The pattern is generated by any one of printing, chemical etching, photo etching, and sputtering, the pattern has a height protruding from the surface of the flexible elongated guide wire, or a depth recessed in the surface of the flexible elongated guide wire.

5. A flexible elongated guidewire resistance index measuring system as recited in claim 1, wherein: The image capturing module comprises, arranged in the channel: a light source; a collimating mirror comprising at least one lens for converging the light source; a reflecting mirror for reflecting the light source converged by the collimating mirror on the pattern on the surface of the flexible elongated guide wire when the part of the flexible elongated guide wire with the pattern passes through the channel; a light sensor for sensing the light beam reflected by the pattern on the surface of the flexible elongated guide wire; a processor electrically connected with the light source, the reflecting mirror, and the light sensor, for controlling the emission pulse of the light source and the deflection angle of the reflecting mirror, and calculating the distance of the optical path by the emission time of the light source and the time of receiving the signal of the light beam reflected by the pattern by the light sensor, combining the distance of the optical path and the deflection angle of the reflecting mirror to calculate the positions of each point on the surface of the pattern in the three-dimensional space, and collecting these points to form a point cloud file, the point cloud file containing the three-dimensional shape and position information of the pattern.

6. A flexible elongated guidewire resistance index measuring system as recited in claim 5, wherein: The image capturing module further comprises a plurality of auxiliary reflecting mirrors for reflecting the light source converged by the collimating mirror on the reflecting mirror, and the reflecting mirror reflects the light source on the pattern on the surface of the flexible elongated guide wire.

7. A method for measuring the resistance index of a flexible elongated guide wire, the distal end of the flexible elongated guide wire being a free end in a circulatory system, and the proximal end being an operating end outside the circulatory system and held by an operator; a pattern being provided on the surface of the proximal end of the flexible elongated guide wire, the pattern comprising a plurality of pattern units, each pattern unit corresponding to a position information, the position information comprising the length of the pattern unit from the distal end of the flexible elongated guide wire, and the phase angle of the pattern unit in the visual angle of the outer ring of the proximal end cross section of the flexible elongated guide wire, and an image capturing module being used to capture the pattern image on the surface of the flexible elongated guide wire and generate a point cloud file; the method comprising the following steps: S1, modeling, using a simulated circulatory system simulating the actual circulatory system of a human body, comprising the following steps: S1.1, establishing a background resistance point cloud file database: in the case of no additional simulated resistance in the simulated circulatory system, i.e. in the case of background resistance, the operator places the distal end of the flexible elongated guide wire into the simulated circulatory system, and pushes the proximal end of the flexible elongated guide wire at any angle to the distal end to the terminal end of the simulated circulatory system, and the operator operates several times, while the image capturing module reads the pattern on the surface of the flexible elongated guide wire to generate a background resistance point cloud file database; S1.2, establishing a simulated resistance point cloud file database: in the case of any simulated resistance in the simulated circulatory system, the operator operates several times to push the distal end of the flexible elongated guide wire to the distal end at any rotation angle, while the image capturing module reads the pattern on the surface of the flexible elongated guide wire to generate a simulated resistance point cloud file database; S1.3, establishing a reference displacement vector database: comparing the corresponding pattern units in the simulated resistance point cloud file database and the background resistance point cloud file database, calculating the displacement vector of the pattern units under the simulated resistance, which is the reference displacement vector of the simulated resistance, calculating the displacement vectors of a plurality of cases to generate a reference displacement vector database; S2, actual application, comprising the following steps: S2.1, establishing an application point cloud file: placing the distal end of the flexible elongated guide wire into the actual circulatory system of a human body, or into a simulated circulatory system with any simulated resistance, and pushing and rotating the flexible elongated guide wire to the distal end by the operator when the distal end of the flexible elongated guide wire encounters resistance, and reading the pattern on the surface of the flexible elongated guide wire by the image capturing module to generate an application point cloud file; S2.2, judging the resistance index: judging the position of the resistance from the pattern units in the application point cloud file, comparing with the corresponding pattern units in the background resistance point cloud file database, calculating the application displacement vector of the pattern units, and comparing the application displacement vector with the corresponding reference displacement vector in the reference displacement vector database to calculate the weight of the application displacement vector in the reference displacement vector distribution interval in the form of numerical difference, and the weight is the resistance index of the flexible elongated guide wire in actual application.

8. The method for measuring the resistance index of a flexible, slender guidewire as described in claim 7, characterized in that: In step S1.3, the image of the simulation resistance point cloud file is processed by image recognition, and then the resistance index is judged by machine learning. The position information and the size of the simulation resistance are used as the labels for machine learning. A reference displacement vector database is established. In step S2.2, the resistance index of the actual application is obtained by machine operation after inputting the application point cloud file.

9. The method for measuring the resistance index of a flexible, slender guidewire as described in claim 7, characterized in that: In step S1.3, the reference displacement vector database is used to calculate the average value and the standard deviation of the reference displacement vector at the resistance corresponding to the case by using the statistical model of Gaussian distribution. The average value plus or minus three times the standard deviation is the upper and lower critical value of the resistance index of the flexible elongated guide wire at the resistance. In step S2.2, if the application displacement vector at the resistance exceeds the critical value range of the resistance index, a prompt module is used to warn the operator.

10. The method for measuring the resistance index of a flexible, slender guidewire as described in claim 9, characterized in that: In step S2.2, the statistical process control method is used. The image acquisition module continuously reads the application point cloud file and calculates the application displacement vector. If the probability of the continuously obtained application displacement vector falling outside the Gaussian distribution increases, a prompt module is used to warn the operator.

11. The method for measuring the resistance index of a flexible, slender guidewire as described in claim 7, characterized in that: The image acquisition module acquires images by using an image sensor or an optical sensor.

12. A method of operation for measuring the resistance index of a flexible elongated guide wire, according to the method of measuring according to claim 7 or 8, characterized in that: In the modeling step of step S1, the construction of the reference displacement vector database is completed by a specific expert operator. In the actual application of step S2, the general operator uses the operation method of the expert operator as a learning specification and reference to complete the placement operation of the flexible elongated guide wire.

13. A method of operation for measuring the resistance index of a flexible elongated guide wire, according to the method of measuring according to claim 7 or 8, characterized in that: The simulation resistance in the simulation circulation system includes the content of the personnel training teaching material, the experience of clinical medical treatment, or the case recorded by the real-time circulation system angiography.

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