Measuring system and method for resistance index of flexible slender guide wire and operation application of measuring system and method

Abstract

The invention provides a measuring system and a measuring method for a resistance index of a flexible slender guide wire and an operation application thereof, the measuring system comprises the flexible slender guide wire, a pattern, an image acquisition module and a prompt module, and the pattern is arranged on the near-end surface of the flexible slender guide wire; the image acquisition module is provided with a channel through which the flexible thin and long guide wire can pass without any obstruction, the image acquisition module acquires an image of the pattern in the channel, and when an operator pushes and rotates the flexible thin and long guide wire into the circulating system, the pattern is deformed due to the fact that the flexible thin and long guide wire is subjected to environmental resistance in the circulating system, and the pattern is displayed on the image acquisition module. The image acquisition module is used for calculating the stress condition of the flexible long and thin guide wire according to the deformation quantity of the pattern and generating a resistance index, and the prompting module is electrically connected with the image acquisition module so as to prompt the resistance index of the flexible long and thin guide wire to an operator, so that the hand feeling of operating the flexible long and thin guide wire by the operator is digitized.

Description

Technical Field

[0001] The present invention relates to the field of slender flexible medical devices, and in particular to a measurement system and method for measuring resistance index of a flexible slender guidewire and its operational application. Background Art

[0002] In medical treatment, a guidewire is placed along the circulatory system to the lesion to treat the lesion. This has been widely used in clinical medicine, such as dialysis catheter thrombosis treatment and cardiac catheterization. When the guidewire is advanced along the circulatory system, even with the guidance of an X-ray machine, the amount of force applied is mostly determined by the operator's experience and feel. Patent CN117897113A discloses a catheter robot and an automatic navigation system. The patent discloses an algorithm that enables the operator to advance the guidewire to the destination along the optimal path. However, during the process of advancing the guidewire, due to obstruction by thrombus or the bending of the circulatory system itself, the operator needs to carefully rotate and advance the guidewire. If the force is not applied carelessly, it may cause harm to the patient. Therefore, in the process of placing the guidewire, providing a standard or reference for force application is a necessary and progressive issue.

[0003] A guidewire inserted into the human circulatory system will experience resistance at a bend in the circulatory system, or when the circulatory system becomes narrow due to a lesion or when there is a thrombus obstruction. The operator must carefully rotate and advance the guidewire. When encountering the aforementioned resistance, the guidewire will deform, which is the strain described in material mechanics. According to Newton's third law of motion, the external force that causes the distal end of the guidewire to bend will react on its proximal end due to the reaction force, causing deformation of its proximal surface. In addition, the operator feels the stress from the distal end and applies force to force the guidewire through the distal obstacle. At this time, the proximal force of the guidewire is the vector sum of the distal obstacle and the proximal force applied by the operator, which is the net force on the guidewire. Based on the principles of mechanics, the present invention discloses a method using imaging and artificial intelligence to convert the net force on the guidewire into a resistance index, which is provided to the operator as a reference for applying force, thereby digitizing the operator's hand feel. Summary of the Invention

[0004] The purpose of the present invention is to provide a measurement system, measurement method and operational application of the resistance index of a flexible and slender guide wire, which converts the net force of the flexible and slender guide wire into a resistance index and provides it to the operator as a force reference, so that the operator can digitize the feel of operating the flexible and slender guide wire.

[0005] To achieve the above objectives, the present invention provides a system for measuring the resistance index of a flexible, slender guidewire, wherein the distal end of the flexible, slender guidewire is the end that enters the circulatory system and can move freely, and the proximal end of the flexible, slender guidewire is located outside the circulatory system and is the operating end that is handheld and operated by an operator. The measurement system comprises:

[0006] A pattern, the pattern being provided on the proximal surface of the flexible elongated guide wire;

[0007] An image capture module is provided with a channel for a flexible, elongated guidewire to pass through. The image capture module captures an image of the pattern within the channel. When an operator holds the operating end of the flexible, elongated guidewire and advances and rotates the flexible, elongated guidewire into the circulatory system, the pattern deforms due to the environmental resistance within the circulatory system. The image capture module calculates the force applied to the flexible, elongated guidewire based on the deformation of the pattern to generate a resistance index.

[0008] The prompt module is electrically connected to the image capture module to prompt the operator of the resistance index of the flexible and elongated guide wire.

[0009] Furthermore, the pattern is located on the proximal outer ring surface of the flexible and slender guide wire, and the pattern includes a number of pattern units, each pattern unit corresponding to a specific position information; the position information includes the length of the pattern unit from the distal end of the flexible and slender guide wire, and the phase angle of the pattern unit located at the outer ring of the proximal cross-section of the flexible and slender guide wire.

[0010] Furthermore, the pattern unit includes a landmark pattern representing distance and a phase pattern representing phase angle. The landmark pattern is used to distinguish the length of the pattern unit from the distal end of the flexible slender guide wire, and the phase pattern is used to distinguish the phase angle of the pattern unit from the perspective of the outer ring of the proximal cross-section of the flexible slender guide wire.

[0011] Furthermore, the pattern is generated by any one of printing, chemical etching, photoetching, and sputtering, and 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] Furthermore, the image capture module includes:

[0013] light source;

[0014] A collimator, comprising at least one lens for focusing the light source;

[0015] a reflector, wherein when the portion of the flexible elongated guide wire with the pattern passes through the channel, the reflector reflects the light source focused by the collimator onto the pattern on the surface of the flexible elongated guide wire;

[0016] a light sensor configured to sense a light beam reflected from a pattern on a surface of the flexible elongated guide wire;

[0017] A processor is electrically connected to the light source, the reflector and the light sensor to control the emission pulse of the light source and the deflection angle of the reflector, and calculates the distance of the optical path through the emission time of the light source and the time when the light sensor receives the signal of the pattern and then reflects the light. In combination with the distance of the optical path and the deflection angle of the reflector, the processor calculates the position of each point on the pattern surface in three-dimensional space, and gathers these points to form a point cloud file, wherein the point cloud file contains the three-dimensional shape and position information of the pattern.

[0018] Furthermore, the image capture module further includes a plurality of auxiliary reflectors, which reflect the light source focused by the collimating mirror onto the reflector, and the reflector reflects the light source onto the pattern on the surface of the flexible elongated guide wire.

[0019] The present invention also provides a method for measuring a 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 is an operating end located outside the circulatory system and handheld by an operator. A pattern is provided on the proximal surface of the flexible, slender guidewire, wherein the pattern includes a plurality of pattern units, each corresponding to position information, the position information including a length of the pattern unit from the distal end of the flexible, slender guidewire and a phase angle of the pattern unit at a perspective of an outer ring of a cross-section of the proximal end of the flexible, slender guidewire. An image capture module captures an image of the pattern on the surface of the flexible, slender guidewire and generates a point cloud file.

[0020] The measuring method comprises the following steps:

[0021] S1. Modeling, which is performed by a simulated circulatory system that simulates the actual circulatory system of the human body, includes the following steps:

[0022] S1.1. Establish background resistance point cloud file database:

[0023] In the case where no simulated resistance is added to the simulated circulatory system, that is, in the case of background resistance, the operator places the distal end of the flexible elongated guidewire into the simulated circulatory system and advances the flexible elongated guidewire distally at any angle from the proximal end to the terminal end of the simulated circulatory system several times. Simultaneously, an image capture module reads the pattern on the surface of the flexible elongated guidewire to generate a background resistance point cloud file database.

[0024] S1.2. Establishing a database of simulated resistance point cloud files:

[0025] Applying arbitrary simulated resistance at any point within the simulated circulatory system is called a case, causing the distal end of the flexible, slender guidewire to encounter the simulated resistance. The operator performs the operation several times in each case, causing the flexible, slender guidewire to advance toward the distal end at any rotation angle. Simultaneously, the image capture module reads the surface pattern of the flexible, slender guidewire to generate a simulated resistance point cloud file database;

[0026] S1.3. Establishing a baseline displacement vector database:

[0027] 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 unit under the simulated resistance as the benchmark displacement vector of the simulated resistance, calculating the displacement vectors of multiple cases, and generating a benchmark displacement vector database;

[0028] S2. Practical application, including the following steps:

[0029] S2.1. Create application point cloud file:

[0030] The distal end of the flexible, slender guidewire is placed into the actual human circulatory system, or into a simulated circulatory system with any simulated resistance. When the distal end of the flexible, slender guidewire encounters resistance, the operator advances and rotates the flexible, slender guidewire distally, and the image capture module reads a pattern on the surface of the flexible, slender guidewire to generate an application point cloud file.

[0031] S2.2. Interpretation of resistance index:

[0032] The location of the resistance is determined by the pattern units in the application point cloud file and compared with the corresponding pattern units in the background resistance point cloud file database to calculate the application displacement vector of the pattern unit. The application displacement vector is then compared with the corresponding reference displacement vector in the reference displacement vector database, and the weight of the application displacement vector in the reference displacement vector distribution interval is calculated by numerical difference. The weight is the resistance index of the actual application of the flexible slender guidewire.

[0033] Furthermore, in step S1.3, the image of the simulated resistance point cloud file is processed by image recognition, and the resistance index is interpreted by machine learning. That is, the position information of the pattern unit and the magnitude of the simulated resistance are used as machine learning labels, and machine learning is performed to establish a reference displacement vector database. Therefore, in the actual application of step S2.2, after the application point cloud file is input, the resistance index of the actual application is obtained by machine calculation.

[0034] Furthermore, in step S1.3, the reference displacement vectors obtained by operating a case several times in the reference displacement vector database are used to calculate the mean value and standard deviation of the reference displacement vector at the resistance point corresponding to the case using the statistical model of Gaussian distribution. The mean value of the reference displacement vector plus or minus three times the standard deviation is the upper and lower critical values ​​of the resistance index of the flexible slender guide wire at the resistance point. In step S2.2, if the calculated application displacement vector at the resistance point exceeds the critical value range of the resistance index, a prompt module is used to alert the operator.

[0035] Furthermore, in step S2.2, the statistical process control method is used. The image capture module continuously reads the application point cloud file and calculates the application displacement vector. If the probability of the continuously acquired application displacement vector falling outside the Gaussian distribution increases, the prompt module warns the operator.

[0036] Furthermore, the image capturing module captures images using an image sensor or an optical sensor.

[0037] The present invention also provides an operational application of a method for measuring the resistance index of a flexible slender guidewire, which is carried out according to the above-mentioned measurement method and is characterized in that: in the modeling step of step S1, a specific expert operator completes the construction of a reference displacement vector database, so that in the actual application of step S2, ordinary operators use the operating method of the expert operator as a learning standard and reference to complete the insertion operation of the flexible slender guidewire.

[0038] The present invention also provides an operational application of another method for measuring the resistance index of a flexible slender guidewire, which is performed according to the above-mentioned measurement method. The simulated resistance in the simulated circulatory system includes the content of personnel training materials, clinical medical experience or cases recorded by real-time circulatory system angiography.

[0039] After adopting the above solution, the beneficial effects of the present invention are:

[0040] The present invention sets a pattern on the proximal surface of the flexible and slender guide wire. When the operator operates the flexible and slender guide wire to advance and rotate in the circulatory system, the distal end of the flexible and slender guide wire encounters environmental resistance, which causes the pattern on the proximal surface to deform. According to the stress of the material, the force condition of the flexible and slender guide wire can be obtained by calculating the deformation amount of the pattern, and a resistance index can be generated. The resistance index can reflect the force application state of the operator; the image capture module is used to obtain the pattern image and calculate the resistance index, and then the prompt module prompts the operator with the resistance index as a force reference.

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

[0042] 1. First, a simulated circulatory system is constructed. The force state of the flexible slender guidewire when encountering a specific simulated resistance is calculated through the simulated circulatory system as a subsequent force reference. The force reference includes the critical value range of the resistance index, the average propulsion distance, and the average rotation angle through the specific resistance. Subsequently, when training or learning the operation method in the simulated circulatory system, or in actual operation applications within the human circulatory system, when the flexible slender guidewire encounters resistance, the application displacement vector of the pattern is calculated to obtain the application resistance index. The application resistance index can be used to determine whether the application displacement vector exceeds the critical value range of the resistance index, or whether the operator's force state has a trend of exceeding the critical value range of the resistance index. If so, the prompt module will issue a warning and display the current application resistance index and force information such as the average propulsion distance and the average rotation angle for the operator's reference, so that the operator can adjust the force state in time to smoothly pass through the environmental resistance, thereby digitizing the operator's feel of operating the flexible slender guidewire.

[0043] 2. Specified expert operators can first operate the flexible, slender guidewire within the simulated circulatory system to provide a reference for applying force when the flexible, slender guidewire encounters specific resistance. Expert operators possess extensive operating experience and techniques. Collecting their operational data can form an expert database, which ordinary operators can then use as prompts and guidance during actual operations. This is equivalent to expert operators providing on-site guidance to ordinary operators, enabling optimal operational results. This service can be provided based on user needs and has high economic value. Furthermore, ordinary operators can also use the simulated circulatory system to learn or train operating techniques and improve their techniques, guided by the prompts of the expert database. BRIEF DESCRIPTION OF THE DRAWINGS

[0044] Figure 1 This is a simulated schematic diagram of the flexible and slender guidewire of the present invention entering the coronary artery from the aorta;

[0045] Figure 2 This is a schematic diagram of the operation of the flexible and elongated guidewire of the present invention;

[0046] Figure 3 This is a top plan view of the flexible elongated guidewire of the present invention;

[0047] Figure 4 is a cross-sectional view of the proximal end of the flexible elongated guidewire of the present invention;

[0048] Figure 5 is a three-dimensional diagram of the first pattern unit of the present invention;

[0049] Figure 6a and 6b They are respectively top views of the first pattern unit of the present invention before and after deformation;

[0050] Figure 7 A schematic structural diagram of an image capture module according to an embodiment of the present invention;

[0051] Figure 8 A schematic structural diagram of an image capture module according to another embodiment of the present invention;

[0052] Figure 9 This is a block diagram of the measurement system of the present invention;

[0053] Figure 10 This is a schematic diagram of the operation of the flexible and slender guidewire of the present invention before it enters the right coronary artery.

[0054] Description of labels:

[0055] 10. Flexible and elongated guidewire; 11. Distal end; 12. Proximal end; 20. Image capture module; 21. Light source; 22. Collimator; 23. Reflector; 24. Processor; 25. Light sensor; 26. Channel; 27. Auxiliary reflector; 30. Prompt 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; 61. Aorta; 62. Right coronary artery; 63. Left coronary artery; 631. Left anterior descending artery; 632. Circumflex artery; 70. Scanning frame. DETAILED DESCRIPTION

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

[0057] In the application documents of the present invention, the term "proximal end" refers to the end of the flexible, slender guidewire that is closer to the operator when inserted into the human body, while the term "distal end" refers to the end that is farther from the operator. "Axial" refers to the length direction of the flexible, slender guidewire during delivery, and "circumferential" refers to the direction clockwise around the central axis of the flexible, slender guidewire itself from the proximal perspective. "Circulatory system" refers to the "human circulatory system" in clinical medicine, and a "simulated circulatory system" constructed at a 1:1 ratio with objective conditions identical to those of the human circulatory system. The simulated circulatory system can adjust its three-dimensional dimensions according to the simulation scenario, and simulated resistance can be added at any point in the simulated circulatory system.

[0058] like Figure 1-10 As shown, the present invention provides a system for measuring the resistance index of a flexible and slender guidewire, wherein the flexible and slender guidewire 10 is a medical device inserted into the circulatory system, and the distal end 11 of the flexible and slender guidewire 10 is the end that can move freely after entering the circulatory system, and the proximal end 12 of the flexible and slender guidewire 10 is located outside the circulatory system and is the operating end that is hand-held and operated by the operator.

[0059] In actual operation, the operator holds the operating end of the flexible, slender guidewire 10 and advances it into the circulatory system until it reaches the target location. The flexible, slender guidewire 10 plays an important role in medical interventional surgery, such as guiding, tracking, supporting, and pushing. However, during the advancement of the flexible, slender guidewire 10, the operator encounters environmental resistance within the circulatory system. The operator needs to carefully advance and rotate the flexible, slender guidewire 10, as any careless application of force can cause damage to the human body.

[0060] The environmental resistance within the circulatory system includes the curvature of the circulatory system itself or thrombosis, such as Figure 1 As shown, taking the coronary artery of the cardiovascular system 60 as an example, the distal end 11 of the flexible, slender guidewire 10 enters the coronary artery from the aorta 61. The flexible, slender guidewire 10 is the guidewire portion of the cardiac catheter 50, which is sheathed 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 no longer advances, and enters the coronary artery from the distal end 11 of the flexible, slender guidewire 10. The coronary artery includes two branches, the right coronary artery 62 and the left coronary artery 63. The left coronary artery 63 further includes two branches, the left anterior descending artery 631 and the circumflex artery 632. The flexible, slender guidewire 10 needs to turn when entering these branches of the coronary artery, which is a bend obstruction of the circulatory system itself, that is, background resistance. In addition, thrombosis in the coronary artery can cause vascular stenosis, which is a lesion obstruction. In the simulated circulatory system of the present invention, simulated resistance is used to simulate lesion obstruction. When the flexible, elongated guidewire 10 encounters the aforementioned environmental resistance, its distal end 11 bends and deforms. According to Newton's third law of motion, the deformation of the distal end 11 of the flexible, elongated guidewire 10 is reflected at its proximal end 12. By measuring the deformation of the proximal end 12, the stress state of the flexible, elongated guidewire 10 can be calculated. It should be noted that the flexible, elongated guidewire 10 of the present invention can be used not only within the cardiovascular system 60 but also in other circulatory systems such as cerebral vessels and dialysis catheters.

[0061] The measurement system of the present invention includes a pattern 40 arranged on the surface of the proximal end 12 of the flexible and slender guide wire 10. The pattern 40 is integrated with the flexible and slender guide wire 10. When the flexible and slender guide wire 10 encounters environmental resistance in the circulatory system, the proximal end 12 of the flexible and slender guide wire 10 will bend and the pattern 40 thereon will also deform. By calculating the deformation amount of the pattern 40, the force applied by the operator can be calculated.

[0062] The measurement system of the present invention also includes an image capture module 20 and a prompt module 30. The image capture module 20 and prompt module 30 are electrically connected. The image capture module 20 is provided with a channel 26 through which the proximal end 12 of the flexible, elongated guidewire can pass unimpeded and be operated by an operator. The movement of the flexible, elongated guidewire 10 is entirely generated by the operator's hands and is not affected by the channel 26. When the operator holds the operating end of the flexible, elongated guidewire 10 and advances and rotates it into the circulatory system, the pattern 40 deforms due to the environmental resistance within the circulatory system. The image capture module 20 captures the shape of the pattern 40 before and after deformation within the channel 26. The image capture module 20 then calculates the deformation of the pattern 40 as the operator's force application and generates a resistance index. The prompt module 30 then displays the resistance index to the operator for reference, digitizing the operator's force application operation on the flexible, elongated guidewire 10.

[0063] Key references Figure 3 and Figure 4 , the pattern 40 is located on the outer ring surface of the proximal end 12 of the flexible elongated guidewire 10, and the pattern 40 includes a plurality of pattern units, each pattern unit corresponding to a specific position information. For example, when the flexible elongated guidewire 10 encounters an environmental resistance, there is a corresponding specific pattern unit that can identify the position of the environmental resistance encountered. The position information includes the length of the pattern unit from the distal end 11 of the flexible elongated guidewire, and the phase angle of the pattern unit located at the outer ring of the cross-section of the proximal end 12 of the flexible elongated guidewire as the perspective. The phase angle represents the circumferential position of the outer ring surface of the proximal end 12 of the flexible elongated guidewire, such as the top surface, left side, right side and bottom surface of the outer ring of the proximal end 12 of the flexible elongated guidewire. For example, when encountering environmental resistance at one position, a pattern unit at the top surface position 111 cm away from the distal end 11 of the flexible elongated guidewire will be deformed.

[0064] Specifically, the pattern unit is composed of several three-dimensional pattern elements, and the advancement distance and phase angle are measured based on the geometric center of the pattern elements that constitute the pattern unit, and different position information is represented by any one or several geometric measurements of the different lengths, widths, diameters, edge lengths, heights and depths of the pattern elements. For example, in one 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 distance information, such as length, width and edge length, etc.

[0065] In another preferred embodiment, the pattern unit is composed of multiple 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 guidewire, and the phase pattern can be used to distinguish the phase angle of the pattern unit located at the outer ring of the cross section of the proximal end 12 of the flexible elongated guidewire. The pattern 40 is preferably composed of a plurality of pattern units arranged on the outer ring surface of the proximal end 11 of the flexible elongated guidewire. Since the plurality of circumferentially distributed pattern units have the same length from the distal end 11 of the flexible elongated guidewire, but are circumferentially distributed at different positions on the outer ring surface of the proximal end 12, the landmark patterns of the circumferentially distributed pattern units are the same, but the phase patterns are different. Similarly, the landmark patterns of the axially distributed pattern units are different, but the phase patterns are the same.

[0066] Specifically, the landmark pattern can be composed of a plurality of three-dimensional pattern elements, and different distance information can be represented by any one or several geometric measurements of different lengths, widths, diameters, edge lengths, heights and depths of the pattern elements; the phase pattern can also be composed of a plurality of three-dimensional pattern elements, and the phase angle information can be represented by the geometric measurements of the pattern elements, but in a preferred embodiment, the phase pattern is composed of a pattern element, and the pattern elements of different phase patterns have different shapes, and pattern elements of different shapes are used to represent different phase angle information.

[0067] The overall length of the flexible, slender guidewire 10 will be adjusted accordingly depending on the height of the human body, so different lengths of flexible, slender guidewires 10 are required for operation. The overall length specifications of the flexible, slender guidewire 10 are 150cm, 160cm, and 170cm, and the longest is over 200cm. Taking the flexible, slender guidewire 10 used 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. Therefore, it is necessary to use a flexible, slender guidewire 10 with different pattern setting positions. The pattern 40 is generally set at 100cm to 105cm from the distal end 11 of the flexible, slender guidewire, and continues to be set along the axial direction toward the proximal end 12. Flexible, slender guidewires of the same length have the same pattern starting end. Generally, resistance appears in a section of about 20 cm in length starting from the time of entering the coronary artery, so the overall length of the pattern 40 along the axial direction is about 20 cm.

[0068] Figure 3This is a top plan view of a flexible, slender guidewire 10 according to an embodiment of the present invention. The position of the pattern 40 thereon shows some 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 patterns of these pattern units are composed of a plurality of rectangular pattern elements representing distance indicators, namely 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 dimensions or width dimensions, corresponding to distance indicators of 1 cm, 2 cm, 5 cm and 10 cm respectively.

[0069] Taking the starting end of the pattern at 100 cm away from the distal end of the flexible and slender guide wire 10 as an example, the landmark pattern of the first pattern unit 41 consists of a first pattern element 45 and a fourth pattern element 48, then the length L1 of the first pattern unit 41 from the distal end 11 of the flexible and slender guide wire is 111 cm, and the 111 cm is the sum of the starting position of the pattern 100 cm, 1 cm corresponding to the first pattern element 45, and 10 cm corresponding to the fourth pattern element 48, that is, L1 = 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 consists of two second pattern elements 46 and one third pattern element 47, and the corresponding distance indicators are 2 cm, 2 cm and 5 cm. The length L2 of the second pattern unit 42 from the distal end 11 of the flexible elongated guide wire is 109 cm.

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

[0072] The landmark pattern of the fourth pattern unit 44 is identical to that of the third pattern unit 43, and both are 103 cm from the distal end of the flexible, elongated guidewire. However, the phase patterns are different. The phase pattern of the third pattern unit 43 is a first phase pattern 411, which appears circular when viewed from above and can be a cylindrical pattern element. The phase pattern of the fourth pattern unit 44 is a second phase pattern 421, which appears triangular when viewed from above and can be a triangular prism pattern element. The first phase pattern 411 and the second phase pattern 421 represent different phase angles. Furthermore, the first pattern unit 41 and the third pattern unit 43 are aligned on the same axis, and the phase pattern of the first pattern unit 41 is identical to that of the third pattern unit 43. The second pattern unit 42 and the fourth pattern unit 44 are aligned on the same axis, and the phase pattern of the second pattern unit 42 is identical to that of the fourth pattern unit 44.

[0073] The number of pattern units distributed circumferentially and axially on the outer ring surface of the proximal end 12 of the flexible elongated guidewire 10 can be set as needed. The greater the number of pattern units, the higher the accuracy of calculating the resistance index of the flexible elongated guidewire 10. For example, when six pattern units are evenly distributed circumferentially on the outer ring surface of the proximal end 12 of the flexible elongated guidewire 10, there are six phase patterns, and the angle between two adjacent phase patterns is 60°. Figure 4 As described above, in this embodiment, taking the vertex P of the outer ring of the cross-section of the proximal end 12 of the flexible and slender guidewire as a reference starting point, the first phase pattern 411 is located at a position 335° clockwise from the vertex P (equivalent to a position 25° counterclockwise), that is, the first phase pattern 411 is a phase of 335° of the circumferential viewing angle of the proximal end 12 of the flexible and slender guidewire, and the second phase pattern 421 is located at a position 60° clockwise from the vertex P, which is a phase of 60° circumferentially of the proximal end 12.

[0074] Figure 5 The three-dimensional shape of the first pattern unit 41 is shown, wherein the first pattern element 45, the fourth pattern element 48, and the first phase pattern 411 have different heights. In this embodiment, the dimensions of each pattern element within the pattern unit are on the order of hundreds of microns (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 and width of polygons and the diameter of circles representing positional information, height or depth can also be used to represent different positional information. Thus, the length and width of a pattern element can represent distance information, while the height represents phase angle information. This reduces the number of pattern elements and the area they occupy, allowing for increased measurement precision by adding more pattern units. The pattern 40 can be generated on the surface of the flexible and slender guide wire 10 by any one of printing, chemical etching, photoetching, and sputtering, so that the pattern 40 has a height protruding from the surface of the flexible and slender guide wire 10, or a depth recessed in the surface of the flexible and slender guide wire 10.

[0075] Key references Figure 7 and Figure 9The image capture module 20 includes a light source 21, a collimator 22, a reflector 23, a light sensor 25, and a processor 24, disposed within a channel 26. The collimator 22 includes at least one lens for focusing the light source 21. For example, for invisible light with a central wavelength of 940 nm, the collimator 22 can focus the light emitted by the light source 21 within a diameter range of 10 μm. When the portion of the flexible, elongated guidewire 10 bearing the pattern 40 passes through the channel 26, the reflector 23 reflects the light focused by the collimator 22 onto the pattern 40 on the surface of the flexible, elongated guidewire 10. After the reflector 23 reflects the light onto the pattern 40, it is further reflected. The light sensor 25 is used to sense the light beam reflected by the pattern 40. The processor 24 is electrically connected to the light source 21, the reflector 23 and the light sensor 25. The processor 24 can control the emission pulse of the light source 21, that is, the emission time. Assuming that the emission time of the light source 21 is controlled to be t1, and the time when the light sensor 25 receives the pattern 40 and then reflects the signal is t2, the distance A between the light sensor 25 and the pattern 40 is calculated based on the time difference and the distance of the optical path. 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 The coordinate elements (A x , A y , A d ), since the light source is emitted by the reflector 23 and received by the light sensor 25, the distance of the optical path is twice the distance between the light sensor 25 and the pattern 40, thereby obtaining a coefficient of 0.5.

[0076] In a preferred embodiment, the reflector 23 is a MEMS reflector. A MEMS reflector is a micro-optical component that integrates a micro-motor, a reflector, and a control circuit. Its operating principle is based on electromagnetic force and mechanical motion. The micro-motor drives the rotation or swing of the reflector to achieve precise control of the optical path. Thus, the processor 24 is electrically connected to the reflector 23, and controlling the deflection angle of the reflector 23 can control the image scanning range. Specifically, the reflector 23 provides an optical deflection area 20 degrees wide and 40 degrees long. Within this deflection area, the processor 24 controls the light source 21, causing it to emit 640 times within a 20-degree sweep width and 1280 times within a 40-degree sweep length. When the light source 21 is in the area of ​​the first pattern unit 41, since 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, the optical sensor 25 receives the reflected light from the first pattern element 45, the first phase pattern 411, and the fourth pattern element 48. The processor 24 calculates the distance of the optical path, and a scanning frame 70 can form a 640 x 1280 point surface 3D image; that is, the coordinate element (A) of the aforementioned point cloud file x , A y , A d ), 1≤x≤640, 1≤y≤1280; the three-dimensional image is a three-dimensional angiography of the pattern 40 in the process of passing through the channel 26 at a horizontal cross-section 111 cm away from the distal end 11 of the flexible elongated guide wire.

[0077] A point cloud file is a storage format for a massive collection of points that express the spatial distribution and surface characteristics of a target within a common spatial reference system. These points typically contain three-dimensional coordinates within the space. The point cloud data within a point cloud file can be stored in a variety of formats, such as PCD, PLY, PTS, and STL. The point cloud data within the point cloud file can be converted into a three-dimensional mesh model using image processing techniques for triangulated mesh data conversion. In the subsequent measurement method computational steps, the point cloud data within the point cloud file is converted into a three-dimensional mesh model using image processing techniques, thereby obtaining the three-dimensional shape and position information of the pattern, thereby processing the deformation of the three-dimensional coordinates of the pattern 40 as the flexible, elongated guidewire 10 advances toward the distal end 11.

[0078] Key references Figure 8In one embodiment, the image capture module 20 includes a plurality of auxiliary reflectors 27, which can reflect the light source focused by the collimator 22 onto the reflector 23, and then the reflector 23 reflects the light source onto the pattern 40 on the surface of the flexible and elongated guide wire 10. The auxiliary reflectors 27 can be set to flexibly adjust the positions of the light source 21 and the collimator 22. For example, the light source 21 and the collimator 22 can be set above the reflector 23, and the auxiliary reflector 27 can be set to the side of the reflector 23. The positions of the light source 21 and the collimator 22 can be flexibly adjusted, which can reduce the space occupied by the image capture module 20, and the auxiliary reflector 27 can be set as needed, without any limitation here.

[0079] The present invention also provides a method for measuring the resistance index of a flexible elongated guidewire, which is performed using the above-mentioned measurement system and includes the following steps:

[0080] S1. Modeling: Constructing a model that simulates the actual human circulatory system to simulate the circulatory system. The simulated circulatory system is used to calculate the force reference when a flexible, slender guide wire encounters resistance at a specific position. The specific position is represented by each pattern unit.

[0081] Please refer to Figure 10 Taking the flexible elongated guidewire 10 entering the right coronary artery 62 as an example, when the flexible elongated guidewire 10 is at the aortic root 71, it is first rotated so that its distal end 11 has a better angle to enter the right coronary artery 62, and then pushed forward into the right coronary artery 62. During this process, in the absence of any lesion obstruction, the environmental resistance encountered inside the circulatory system is the background resistance. In this embodiment, when the distal end 11 of the flexible elongated guidewire 10 enters the coronary artery, it is about 100 cm away from the operator, which is the starting position of the set of patterns 40, and the relevant point cloud file data is recorded accordingly. This starting position can be changed according to the case requirements of the clinical application.

[0082] The specific steps include:

[0083] S1.1. Establish background resistance point cloud file database:

[0084] In the case where no simulated resistance is added to the simulated circulatory system, that is, in the case of background resistance, the operator places the distal end 11 of the flexible, slender guidewire into the simulated circulatory system and advances the proximal end 12 of the flexible, slender guidewire toward the distal end 11 at any angle to the terminal end of the simulated circulatory system, which is the end of the right coronary artery 62, the left anterior descending artery 631, and the left circumflex artery 632. This operation is repeated several times, while the image capture module 20 reads the pattern 40 on the surface of the proximal end 12 of the flexible, slender guidewire, and the processor 24 calculates and generates a background resistance point cloud file. Figure 3Only four pattern units are shown in the figure, and each pattern unit has only one phase pattern. In actual operation, more pattern units can be set according to the size of the pattern.

[0085] The processor 24 can set the sampling rate according to the precise requirements, such as capturing 60 frames per second (i.e. 60Hz). If the operator completes the first pattern unit 41 through the mechanism channel 26 in 2 seconds under the condition of background resistance, there will be 120 frames of recorded point cloud files. After several operations, the acquisition of the background resistance point cloud file data at 111cm from the distal end 11 of the flexible slender guide wire is completed. The 111cm corresponds to Figure 2 The distal end 11 of the flexible, elongated guidewire 10 is located at a specific location. Flexible, elongated guidewires 10 of varying shapes are then used to penetrate the terminal ends of the right coronary artery 62, the left anterior descending artery 631, and the left circumflex artery 632 in simulated circulatory systems of varying sizes. After several manipulations, each pattern unit will contain multiple sampling results, completing a background resistance point cloud file database containing manipulation data for different lengths and coronary artery branches.

[0086] S1.2. Establishing a database of simulated resistance point cloud files:

[0087] When adding a specific simulated resistance to the simulated circulatory system, the operator inserts a flexible, slender guidewire 10 into the simulated circulatory system and advances the guidewire's proximal end 12 toward the distal end 11 at any angle to the added specific simulated resistance, repeating this operation several times. This specific simulated resistance, for example, involves inserting a simulated thrombus-like obstructing substance into the right coronary artery 62 or the left anterior descending artery 631, which have smaller cross-sectional diameters. The specific simulated resistance is a simulated scenario based on all possible obstructions in the circulatory system obtained through clinical experience and actual circulatory system angiography, including the location and magnitude of the resistance, to achieve a simulated effect. Each specific simulated resistance added corresponds to each simulated scenario, i.e., a case study. When the operator encounters simulated resistance, they increase the force of propulsion and rotation to break through it. If they successfully pass through, they return to the background resistance state.

[0088] Following the same principles as 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 guidewire. The processor generates a simulated resistance point cloud file. The operator performs this operation several times for each case, completing a database of simulated resistance point cloud files for each specific case. If the simulated resistance is too high to overcome with standard procedures, further surgical methods, such as balloon dilation, are required. The maximum force applied in this situation will be set as the maximum applied force.

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

[0090] In the following description, the point cloud files described have already completed the pre-processing steps of triangulation and image recognition. The rotation angle and propulsion distance are derived from the landmark patterns and phase patterns in the point cloud files recorded by the image capture module 20, processed using image processing techniques for triangulation data conversion, and then calculated using the trajectory vectors of the pattern units. Furthermore, in addition to the method proposed in this embodiment, other methods can be used to calculate the data in the database, obtaining the displacement relationship between the simulated resistance and the background resistance, and achieving the same effect.

[0091] Establishing a reference displacement vector database specifically includes the following steps:

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

[0093] In multiple pattern captures operating under background resistance:

[0094] In the Nth pattern capture, the center of the frame is the first pattern unit 41, the position is 111 cm, and the angle is 335 degrees;

[0095] In the N+1 pattern capture, the center of the frame is identified as 111 cm and 320 degrees;

[0096] In the N+2 pattern capture, the center of the frame is identified as 112 cm and 320 degrees;

[0097] In the Mth pattern capture, the center of the frame is identified at 111 cm and 60 degrees;

[0098] In the M+1 pattern capture, the center of the frame was identified as 111 cm and 46 degrees;

[0099] In the M+2 pattern capture, the center of the frame was identified as 111.4 cm and 46 degrees;

[0100] During the M+3 pattern capture, the center of the frame was identified as 112 cm and 46 degrees.

[0101] So we calculate:

[0102] The movements from N to N+2 are: first rotate 15 degrees clockwise, then push forward 1 cm;

[0103] The movements from M to M+2 are: first rotate 14 degrees clockwise, then push forward 0.4 cm;

[0104] The movements from M to M+3 are: first rotate 14 degrees clockwise, then push forward 1 cm;

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

[0106] Clearly, at the center of the frame, these two operations advance the guidewire from 111 cm to 112 cm, with the flexible, elongated guidewire 10 rotating clockwise by 15 and 14 degrees, respectively. Because the image capture sampling time is fixed, M operations capture three patterns, taking a relatively long time, but still achieving the target distance.

[0107] When the distal end 11 of the flexible elongated guidewire encounters the simulated resistance, the image capture module 20 captures the point cloud file 111 cm away from the distal end 11 for the Lth time. After recognition, the top view of the deformed first pattern unit 41 is shown in FIG6B , and the multiple captures of the pattern are as follows:

[0108] For the Lth pattern capture, the center of the frame is the first pattern unit 41, located at 111 cm and 335 degrees;

[0109] In the L+1 pattern capture, the center of the frame is identified as 111 cm and 290 degrees;

[0110] In the L+2 pattern capture, the center of the frame was identified as 112 cm and 290 degrees;

[0111] So we calculate:

[0112] The movement from L to L+2 is: first rotate 45 degrees clockwise, then move forward 1 cm.

[0113] When the far end 11 encounters simulated resistance, the trajectory vector at 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 point cloud file. If the time or rotation angle required to move the same distance is significantly different from that of the background main point cloud file, it is determined that simulated resistance is encountered.

[0114] S1.3.2. Calculate the reference displacement vector for each simulated resistance case:

[0115] Taking the position information of each pattern unit with 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 capture is the first pattern unit 41, located 111 cm from the far end and with a phase angle of 335 degrees. The corresponding background resistance point cloud file is the Nth pattern capture with the same phase angle; the Mth pattern capture is not applicable due to the different phase angle. The frame at this location is identified and illustrated in Figures 6A and 6B, which show top views of the first pattern unit 41 before and after deformation. Figure 6A shows the Nth pattern capture, and Figure 6B shows the Lth pattern capture for simulated resistance. The material of the flexible and slender guide wire 10 involved in the present invention is a metal material, which can recover after being deformed by external force. Therefore, Hooke's law in material mechanics is applicable. After a solid material within the elastic range is subjected to force, the stress and strain are in a linear relationship. Taking a pattern element of a landmark pattern as the base point, the pattern element and its adjacent pattern elements are made of the same solid material, and the deformation generated by the pattern element and its adjacent pattern elements are all the same deformation coefficient. Therefore, the displacement vector of the pattern unit can be calculated using any pattern element of the pattern unit.

[0117] In this embodiment, the reference displacement vector is calculated using pattern elements of the first phase pattern 411. In other embodiments, the calculation can also be performed on any pattern element in the landmark pattern of the first pattern unit 41. As shown in Figures 6A and 6B, the X-axis deformation of the first phase pattern 411 is x1-x0. The same principle can be applied to the Y-axis and Z-axis. After calculating the single-axis deformation, the displacement vector magnitude of the first phase pattern 411 caused by the deformation under the specific background resistance is calculated as (x1-x0). 2 +(y1–y0) 2 +(z1–z0) 2 〕 1 / 2 , and the direction is the direction of the vector sum of the components of each axis on three vertical axes that form a 90° angle with each other. The magnitude and direction of the displacement vector constitute the reference displacement vector.

[0118] Because the simulated resistance point cloud file is generated through multiple operations, the applied force of the simulated resistance each time varies. For example, in step S1.2, in addition to the Lth operation, there are K and J operations encountering resistance at the same location. In these operations, the center of the captured pattern is the first pattern unit 41, but the applied force varies slightly. Using the first phase pattern 411 of each first pattern unit 41 obtained from each point cloud file, the reference displacement vector for each operation is calculated to obtain:

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

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

[0121] The Jth operation: displacement vector size 19.5 μm, axial force 108 degrees.

[0122] The trajectory vector of each operation in the simulated resistance point cloud file database is mapped to the corresponding associated trajectory of the background resistance point cloud file database to complete the benchmark displacement vector database when encountering the specific resistance. The statistical parameters of the benchmark displacement vector database are then calculated using a statistical Gaussian distribution model, including the mean and standard deviation of the benchmark displacement vector, to quantify the stress state of the flexible elongated guide wire 10. The mean value of the benchmark displacement vector plus or minus three times the standard deviation is the upper and lower critical values ​​of the resistance index of the flexible elongated guide wire 10 when encountering a specific simulated resistance. If the statistical model calculates that the mean value of the displacement vector size is 21 microns and the standard deviation is 1 micron, it can be known that when encountering the specific resistance, the operation data will have a 99.73% probability of the displacement vector being in the range of 18 to 24 microns.

[0123] S2. Practical application. Application scenarios include operators using a simulated circulatory system to learn or train operating techniques, as well as performing actual operations in the actual human circulatory system. This can include using a simulated circulatory system for operator training, or in clinical practice, selecting a baseline displacement vector database similar to a case after coronary angiography, or selecting a baseline displacement vector database containing all cases to assist operators. Specifically, the following steps are included:

[0124] S2.1. Create application point cloud file:

[0125] The distal end 11 of the flexible, slender guide wire is placed into the actual human circulatory system, or into a simulated circulatory system with any simulated resistance. When the distal end 11 of the flexible, slender guide wire encounters resistance, the operator pushes and rotates the flexible, slender guide wire toward the distal end 11, so that it passes through the channel 26 of the image capture module 20 and is pushed toward the distal end. The image capture module 20 reads the pattern 40 on the surface of the proximal end 12 of the flexible, slender guide wire to generate an application point cloud file; the operation data of the application point cloud file can be compiled into an application point cloud file database for the operation, which is used to reconstruct the operation process as a reference for future improvements.

[0126] S2.2. Interpretation of resistance index:

[0127] The processor 24 compares the trajectory vector of the pattern unit in the real-time generated application point cloud file with the trajectory vector of the same pattern unit in the corresponding background resistance point cloud file to determine whether the position where resistance is encountered is reached. Once it is confirmed that resistance is encountered, the displacement vector of the pattern element of the pattern unit corresponding to the resistance at that 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 can be calculated as the application displacement vector, and then 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. The weight is the resistance index of the actual application of the flexible slender guide wire 10.

[0128] For example, if the calculated applied displacement vector size is 19 microns, the resistance index is ((19-18) / (24-18)) x 100% = 16.7%. The 16.7% resistance index represents the proportion of the applied operation force within the critical range of the resistance index, which can reflect the current force application state, which includes the distance of propulsion and the angle of rotation. If the resistance index is within the range of 0 to 100%, it means that the force application state of the current operation can pass through the resistance at that location and will not cause damage to the circulatory system. If the maximum force obtained in step S1.2 is 26 microns, once the calculated displacement vector size reaches 26 microns, or the calculated resistance index is close to 100%, it means that further surgical methods must be used, such as balloon dilation.

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

[0130] During the interpretation of the resistance index, if the processor 24 determines that the applied displacement vector exceeds the critical value range of the resistance index corresponding to the resistance obtained in step S1.3, that is, exceeds the average value of the baseline displacement vector of the pattern corresponding to the resistance at that location plus or minus three times the standard deviation, then the operator's force is too large. Continuing to advance the flexible and slender guide wire 10 in this force state will not be able to pass through the resistance at that location and may even damage the circulatory system. Therefore, the prompt module 30 will promptly warn the operator at this time, prompting the operator to adjust the force state in time and adjust the applied resistance index to within the critical value range of the resistance index in order to smoothly pass through the resistance.

[0131] At the same time, in the actual application of step S2, the processor 24 continuously obtains real-time point cloud files. To prevent the operator from failing to adjust the force state in time, the present invention uses the statistical model of Gaussian distribution and cooperates with the control method of "statistical process control" to prompt the operator to adjust the force state in time. According to the Gaussian distribution curve, the referenced principle is:

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

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

[0134] The probability of distribution within the range of mean ± 3 times standard deviation is 99.73%.

[0135] Because the probability of falling between the mean plus or minus one standard deviation and plus or minus three standard deviations is calculated to be 99.73% - 68.26% = 31.47%, in terms of probability, if the distribution is very uniform, at most only one of the three consecutive sampled points will fall within this range. Therefore, although the displacement vector magnitudes obtained for several consecutive times do not exceed the critical value range of the resistance index, if they exceed the range of the mean plus or minus one standard deviation for several consecutive times and the probability continues to increase, then the continuously read application displacement vectors have a tendency to exceed the critical value range of the resistance index. The preferred control method is to alert the operator through the prompt module 30 when the displacement vector magnitude exceeds the range of the mean plus or minus one standard deviation for three consecutive times, that is, when the application resistance index obtained by three consecutive sampling calculations is greater than 68.26% and continues to increase, to achieve the purpose of prevention and allow the operator sufficient time to make adjustments. It should be noted that the method of issuing a warning when the size of the displacement vector taken three times in a row exceeds the range of the mean value plus or minus one standard deviation is only one of the control methods of "statistical process control". Other control methods can also be used. For example, if the displacement vector is taken three times in a row and two of them are not within the range of the mean value plus or minus one standard deviation, a warning will be issued. Based on the Gaussian distribution curve as the basic principle, different control methods can be used.

[0136] In addition to providing warnings, the prompt module 30 can also display the applied resistance index and force status information such as the average propulsion distance and average rotation angle calculated from the simulated resistance point cloud file database for the operator's reference, ensuring that the operator can successfully guide the flexible, slender guidewire 10 through the environmental resistance. The average propulsion distance and rotation angle of the flexible, slender guidewire 10 under the background resistance and simulated resistance are obtained by calculating the trajectory vectors of each pattern unit performed multiple times in steps S1.1 and S1.2. The prompt module 30 can alert the operator using at least one of the following: on-screen graphics, lighting, or sound.

[0137] The present invention provides another method for processing point cloud files. After identification, each frame of the point cloud file is labeled with simulated resistance and the specific position information of each pattern unit for machine learning to establish a baseline displacement vector database. For example, the magnitude of the simulated resistance is classified 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. The image of the point cloud file can then be applied to the TensorFlow system to perform machine learning modeling. The purpose of this machine learning is to identify the relative position and displacement vector changes of the relevant patterns in the point cloud file, identify the magnitude level and location of the simulated resistance, and use it as a reference for subsequent practical applications. During the actual application of step S2, the processor 24 can be modeled by the trained TensorFlow system. After inputting the application point cloud file, the machine calculation obtains the resistance index for the actual application, and the prompt module 30 prompts the resistance index.

[0138] The operations of steps S1.1 and S1.2 include operations performed several times in different circulatory systems using flexible slender guide wires 10 of different lengths or different shapes. The length of the flexible slender guide wire 10 will be adjusted according to the height of the human body, and different interventional surgeries will have different requirements for the shape of the flexible slender guide wire 10, so the flexible slender guide wire 10 has a variety of lengths and shapes. In obtaining the background resistance point cloud file and the simulated resistance point cloud file, it is necessary to operate multiple times with flexible slender guide wires 10 of different lengths and different shapes, and record them in the corresponding point cloud files respectively, so that they can be applied to various operation scenarios in the subsequent step S2.

[0139] In another embodiment, the image capture module includes more than two cameras, which generates a three-dimensional image of the surface pattern of the flexible slender guide wire 10 by 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 present invention also provides an operational application of a method for measuring the resistance index of a flexible, slender guidewire, which is performed according to the aforementioned measurement method, including, in the modeling step of step S1, a specific expert operator completes the construction of a reference displacement vector database, thereby completing the force reference when the flexible, slender guidewire 10 encounters resistance. The expert operator has extensive operating experience and operating techniques. The operation data of the expert operator can be collected to form an expert database. In the actual application of step S2, ordinary operators can call this expert database as a reference during actual operation, which is equivalent to the expert operator guiding the ordinary operator on site, which can achieve better operating results and can provide such services according to user needs. For example, in the case of a shortage of expert operator resources, ordinary operators can use this operation application to achieve better clinical medical results, meet user needs, and have high economic value. In addition, ordinary operators can also use the simulated circulatory system to learn or train operating techniques under the prompts and guidance of the expert database to improve their operating techniques. This operation application has a good training effect and can be widely used in teaching.

[0141] The present invention also provides another operational application of a flexible, slender guidewire resistance index measurement method. In the above-mentioned measurement method, the simulated resistance in the simulated circulatory system includes the content of personnel training materials, clinical medical experience, or cases recorded by real-time circulatory system angiography.

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

[0143] The above description is only a preferred embodiment of the present invention and is not intended to limit the design of this case. Any equivalent changes made based on the key design of this case shall fall within the scope of protection of this case.

Claims

1. A system for measuring 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 an operating end that is handheld by an operator, characterized in that: The measurement system comprises: A pattern, the pattern being provided on the proximal surface of the flexible elongated guide wire; An image capture module is provided with a passage through which a flexible, slender guidewire can pass without any obstruction. The image capture module captures an image of the pattern within the passage. When an operator holds the operating end of the flexible, slender guidewire and advances and rotates the flexible, slender guidewire into the circulatory system, the pattern deforms due to the environmental resistance within the circulatory system. The image capture module calculates the force applied to the flexible, slender guidewire based on the deformation of the pattern to generate a resistance index. The prompt module is electrically connected to the image capture module to prompt the operator of the resistance index of the flexible and elongated guide wire.

2. The system for measuring resistance index of a flexible elongated guidewire according to claim 1, wherein: The pattern is located on the proximal outer ring surface of the flexible and slender guide wire, and the pattern includes a plurality of pattern units, each pattern unit corresponding to a specific position information; the position information includes the length of the pattern unit from the distal end of the flexible and slender guide wire, and the phase angle of the pattern unit from the perspective of the outer ring of the proximal cross-section of the flexible and slender guide wire.

3. The system for measuring resistance index of a flexible elongated guidewire according to claim 2, wherein: The pattern unit includes a landmark pattern representing distance and a phase pattern representing phase angle. The length of the pattern unit from the distal end of the flexible slender guide wire is distinguished by the landmark pattern, and the phase angle of the pattern unit located at the outer ring of the proximal cross-section of the flexible slender guide wire is distinguished by the phase pattern.

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

5. The system for measuring resistance index of a flexible elongated guidewire according to claim 1, wherein: The image capture module includes: light source; A collimator, comprising at least one lens for focusing the light source; a reflector, wherein when the portion of the flexible elongated guide wire with the pattern passes through the channel, the reflector reflects the light source focused by the collimator onto the pattern on the surface of the flexible elongated guide wire; a light sensor configured to sense a light beam reflected from a pattern on a surface of the flexible elongated guide wire; A processor is electrically connected to the light source, the reflector and the light sensor to control the emission pulse of the light source and the deflection angle of the reflector, and calculates the distance of the optical path through the emission time of the light source and the time when the light sensor receives the signal of the pattern and then reflects the light. In combination with the distance of the optical path and the deflection angle of the reflector, the processor calculates the position of each point on the pattern surface in three-dimensional space, and gathers these points to form a point cloud file, wherein the point cloud file contains the three-dimensional shape and position information of the pattern.

6. The system for measuring resistance index of a flexible elongated guidewire according to claim 5, wherein: The image capture module further includes a plurality of auxiliary reflectors, which reflect the light source focused by the collimator onto the reflector, and the reflector reflects the light source onto the pattern on the surface of the flexible elongated guide wire.

7. A method for measuring 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 is an operating end located outside the circulatory system and is handheld and operated by an operator; a pattern is provided on the proximal surface of the flexible, slender guidewire, the pattern comprising a plurality of pattern units, each corresponding to position information, the position information comprising a length of the pattern unit from the distal end of the flexible, slender guidewire and a phase angle of the pattern unit at a perspective of an outer ring of a cross-section of the proximal end of the flexible, slender guidewire; an image capture module captures an image of the pattern on the surface of the flexible, slender guidewire and generates a point cloud file; The measuring method comprises the following steps: S1. Modeling, which is performed by a simulated circulatory system that simulates the actual circulatory system of the human body, includes the following steps: S1.

1. Establish background resistance point cloud file database: In the case where no simulated resistance is added to the simulated circulatory system, that is, in the case of background resistance, the operator places the distal end of the flexible elongated guidewire into the simulated circulatory system and advances the flexible elongated guidewire distally at any angle from the proximal end to the terminal end of the simulated circulatory system several times. Simultaneously, an image capture module reads the pattern on the surface of the flexible elongated guidewire to generate a background resistance point cloud file database. S1.

2. Establishing a database of simulated resistance point cloud files: Applying arbitrary simulated resistance at any point within the simulated circulatory system is called a case, causing the distal end of the flexible, slender guidewire to encounter the simulated resistance. The operator performs the operation several times in each case, causing the flexible, slender guidewire to advance toward the distal end at any rotation angle. Simultaneously, the image capture module reads the surface pattern of the flexible, slender guidewire to generate a simulated resistance point cloud file database; S1.

3. Establishing a baseline 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 unit under the simulated resistance as the benchmark displacement vector of the simulated resistance, calculating the displacement vectors of multiple cases, and generating a benchmark displacement vector database; S2. Practical application, including the following steps: S2.

1. Create application point cloud file: The distal end of the flexible, slender guidewire is placed into the actual human circulatory system, or into a simulated circulatory system with any simulated resistance. When the distal end of the flexible, slender guidewire encounters resistance, the operator advances and rotates the flexible, slender guidewire distally, and the image capture module reads a pattern on the surface of the flexible, slender guidewire to generate an application point cloud file. S2.

2. Interpretation of resistance index: The location of the resistance is determined by the pattern units in the application point cloud file and compared with the corresponding pattern units in the background resistance point cloud file database to calculate the application displacement vector of the pattern unit. The application displacement vector is then compared with the corresponding reference displacement vector in the reference displacement vector database, and the weight of the application displacement vector in the reference displacement vector distribution interval is calculated by numerical difference. The weight is the resistance index of the actual application of the flexible slender guidewire.

8. The method for measuring the resistance index of a flexible elongated guidewire according to claim 7, wherein: In step S1.3, the image of the simulated resistance point cloud file is processed by image recognition, and the resistance index is interpreted by machine learning. That is, the position information of the pattern unit and the magnitude of the simulated resistance are used as machine learning labels, and machine learning is performed to establish a reference displacement vector database. In the actual application of step S2.2, after the application point cloud file is input, the resistance index of the actual application is obtained by machine calculation.

9. The method for measuring the resistance index of a flexible elongated guidewire according to claim 7, wherein: In step S1.3, the reference displacement vectors obtained by operating a case several times in the reference displacement vector database are used to calculate the mean value and standard deviation of the reference displacement vector at the resistance point corresponding to the case using the statistical model of Gaussian distribution. The mean value of the reference displacement vector plus or minus three times the standard deviation is the upper and lower critical values ​​of the resistance index of the flexible slender guidewire at the resistance. In step S2.2, if the calculated application displacement vector at the resistance point exceeds the critical value range of the resistance index, a prompt module is used to alert the operator.

10. The method for measuring the resistance index of a flexible elongated guidewire according to claim 9, wherein: In step S2.2, the statistical process control method is used. The image capture module continuously reads the application point cloud file and calculates the application displacement vector. If the probability of the continuously acquired application displacement vector falling outside the Gaussian distribution increases, the prompt module warns the operator.

11. The method for measuring the resistance index of a flexible elongated guidewire according to claim 7, wherein: The image capturing module captures images using an image sensor or an optical sensor.

12. An operational application of a method for measuring resistance index of a flexible elongated guidewire, performed according to the measurement method of claim 7 or 8, characterized in that: In the modeling step of step S1, a specific expert operator completes the construction of the reference displacement vector database, so that in the actual application of step S2, ordinary operators use the operating methods of the expert operators as learning standards and references to complete the insertion operation of the flexible slender guidewire.

13. An operational application of a method for measuring resistance index of a flexible elongated guidewire, performed according to the measurement method of claim 7 or 8, characterized in that: The simulated resistance in the simulated circulatory system includes the content of personnel training materials, clinical medical experience or cases recorded by real-time circulatory system angiography.

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