A spiral guide wire device and its resistance adjustment method

Abstract

This invention relates to the field of medical device technology and discloses a spiral guidewire device and its resistance adjustment method. The device includes: a guidewire body comprising a core and a spiral outer sheath, the spiral outer sheath being a PTFE-coated layer with spiral grooves; a compression device for compressing the guidewire body, comprising a cylinder, a compression ring, a speed sensor, and a torque motor, the compression ring being sleeved on the outside of the cylinder, the torque motor driving the compression ring to rotate via a transmission chain, the cylinder being provided with a compression block that cooperates with a compression ball, and the speed sensor being located at the cylinder outlet for collecting the speed value of the guidewire body during delivery; a control device electrically connected to the speed sensor and the torque motor; the control device dynamically adjusts the resistance of the guidewire body by collecting the speed value from the speed sensor and dynamically controlling the forward and reverse rotation of the torque motor based on the speed value. This invention ensures the stability of the guidewire entry speed through dynamic adjustment of guidewire resistance.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more specifically, to a spiral guidewire device and its resistance adjustment method. Background Technology

[0002] In existing guidewire delivery technologies, guidewire devices are widely used in the delivery of vascular guidewires or minimally invasive instruments. However, when the guidewire enters the operating channel, the advance speed of the guidewire body is often difficult to control precisely, especially in narrow or tortuous areas of the lumen. The guidewire is prone to uneven acceleration or deceleration, which increases operational risks and affects positioning accuracy.

[0003] Existing technologies typically rely on operators manually adjusting the feed speed, but this method is highly susceptible to human error and cannot achieve stable and repeatable guidewire delivery speed control. Some devices attempt to directly drive the guidewire forward using a fixed power unit, but when the friction between the guidewire and the pipe varies significantly, the stability of the entry speed cannot be guaranteed, and the pipe can easily rupture due to excessive guidewire entry speed.

[0004] Therefore, it is necessary to design a spiral guide wire device and its resistance adjustment method to solve the problems existing in the current technology. Summary of the Invention

[0005] In view of this, the present invention proposes a spiral guide wire device and its resistance adjustment method, aiming to solve the problem that the current method cannot guarantee the stability of the entry speed and is prone to tube rupture due to excessive guide wire entry speed.

[0006] In one aspect, the present invention provides a spiral guide wire device, comprising: a guide wire body, a pressing device, a control device, and a base;

[0007] The guidewire body includes a wire core and a spiral outer sheath. The wire core is made of metal, and the spiral outer sheath is a PTFE coating layer. The surface of the spiral outer sheath has spiral grooves. The end of the guidewire body is a soft tip, and the surface of the soft tip is provided with a hydrophilic coating.

[0008] The extrusion device is used to extrude the guide wire body and includes a cylinder, an extrusion ring, a speed sensor, and a torque motor. The cylinder is fixed to the base by a bracket. The extrusion ring is sleeved on the outside of the cylinder and rotatably connected relative to the axis of the cylinder. The torque motor drives the extrusion ring to rotate through a transmission chain. An extrusion ball is provided inside the extrusion ring. The cylinder is provided with an extrusion block that cooperates with the extrusion ball. The cylinder is also provided with an elastic component for compressing force. The two ends of the elastic component are respectively connected to the cylinder and the extrusion block. The speed sensor is located at the outlet of the cylinder and is used to collect the speed value when the guide wire body is delivered.

[0009] The control device is electrically connected to the speed sensor and the torque motor; the control device collects the speed value of the speed sensor and dynamically controls the forward and reverse rotation of the torque motor based on the speed value to dynamically adjust the resistance of the guide wire body.

[0010] In another aspect, the present invention proposes a resistance adjustment method for a spiral guide wire device, for use with the above-mentioned spiral guide wire device, comprising:

[0011] The velocity values ​​of the velocity sensor are acquired in real time based on the Savitzky-Golay filtering method. The velocity values ​​are compared with the velocity threshold to determine whether the resistance value of the guidewire body needs to be adjusted.

[0012] When it is determined that the resistance value needs to be adjusted, a torque motor rotation scheme is determined, and a torque motor rotation angle value is selected from the determined torque motor rotation scheme based on DBSCAN clustering; the torque motor is adjusted based on the torque motor rotation angle value.

[0013] The resistance of the guide wire body is dynamically adjusted by regulating the rotation direction and angle of the torque motor.

[0014] Furthermore, when acquiring the velocity values ​​from the velocity sensor in real time based on the Savitzky–Golay filtering method, the following steps are included:

[0015] The speed sensor continuously outputs a speed data stream at a fixed sampling frequency and stores the speed data stream in a circular buffer in real time; it automatically extracts a sliding window of each new sampling point and several adjacent sampling points before and after it; within the sliding window, it fits a low-order polynomial based on the least squares method and uses the function value of the low-order polynomial at the center point of the window as the speed value at the current moment.

[0016] Furthermore, when fitting low-order polynomial values ​​based on the least squares method, the following applies:

[0017] Collect all data points within the sliding window and select several adjacent data points as sample points; construct the corresponding polynomial function according to the set order of the fitting polynomial; calculate the coefficients of the polynomial function using the least squares method based on the sample points, and minimize the sum of squared errors between the actual values ​​and the fitted values ​​of the sample points; fit the data points within the window interval according to the polynomial function to obtain the low-order polynomial values.

[0018] Furthermore, when comparing the speed value with the speed threshold to determine whether it is necessary to adjust the resistance value of the guidewire body, the process includes:

[0019] The speed threshold includes a first speed threshold and a second speed threshold; the first speed threshold is smaller than the second speed threshold.

[0020] When the speed value is less than or equal to the first speed threshold, it is determined that the resistance value of the guidewire body needs to be reduced.

[0021] When the speed value is greater than the first speed threshold and less than the second speed threshold, it is determined that the resistance value of the guidewire body does not need to be adjusted.

[0022] When the speed value is greater than or equal to the second speed threshold, it is determined that the resistance value of the guidewire body needs to be increased.

[0023] Furthermore, when it is determined that the resistance value needs adjustment, the torque motor rotation scheme is determined by including:

[0024] The torque motor rotation scheme includes a forward rotation scheme and a reverse rotation scheme.

[0025] When it is necessary to reduce the resistance value of the guide wire body, the torque motor reversal scheme is adopted.

[0026] When it is necessary to increase the resistance value of the guide wire body, the forward rotation scheme of the torque motor is adopted.

[0027] Furthermore, when selecting the torque motor rotation angle value based on the determined torque motor rotation scheme using DBSCAN clustering, the process includes:

[0028] Obtain all rotation angle values ​​and corresponding feature data of the torque motor rotation scheme, and construct a historical data set; the feature data includes torque motor feature data and guide wire motion feature data; standardize the rotation angles and feature data in the historical data set; integrate the historical data set with the data set constructed from the current feature data to form a clustering set;

[0029] The set to be clustered is clustered according to DBSCAN clustering, and the rotation angle value is determined based on the clustering results.

[0030] Furthermore, the set to be clustered is clustered according to DBSCAN clustering. When determining the rotation angle value based on the clustering results, the following steps are taken:

[0031] S1: For each data point, determine the set of its neighboring points within its ε-neighborhood;

[0032] S2: If the number of neighboring points is greater than or equal to the preset minimum number of neighbors minPts, then mark the data point as a core point and add the points in its neighborhood to the same cluster;

[0033] S3: Repeat S1 and S2 for the new core points within the cluster until the cluster expansion is complete;

[0034] S4: When the cluster containing the data set does not contain a historical data set, the historical rotation angle value corresponding to the maximum similarity between the data set and the historical data set is selected as the initial rotation angle value; when the cluster containing the data set contains a historical data set, the average value of the historical rotation angle values ​​corresponding to all the historical data sets contained therein is selected as the rotation angle value.

[0035] Furthermore, when selecting the historical rotation angle value corresponding to the maximum similarity between the data set and the historical data set as the initial rotation angle value, the following steps are included:

[0036] The similarity coefficient between the dataset and the historical dataset is calculated using the Euclidean distance algorithm. The similarity coefficient is then used as a correction coefficient to correct the initial rotation angle value, which is then used as the final rotation angle value.

[0037] Furthermore, when calculating the similarity coefficient between the dataset and the historical dataset based on the Euclidean distance algorithm, the following steps are included:

[0038] The feature data that has the maximum similarity between the data set and the historical data set is determined, and the feature data is standardized. The difference between each pair of corresponding data in the feature data is calculated, and the difference is squared. The squared differences of all data are summed to obtain the overall difference value. The square root of the overall difference value is then calculated to obtain the Euclidean distance between the data set and the historical data set with the maximum similarity in the multidimensional feature space. The Euclidean distance is normalized according to the maximum and minimum distances of all data. The similarity coefficient is obtained by subtracting the normalized Euclidean distance from 1.

[0039] Compared with existing technologies, the advantages of this invention are as follows: By setting a soft tip and a hydrophilic coating at the end of the guidewire body, and designing the PTFE-coated outer surface of the guidewire as a spiral groove, the frictional resistance of the guidewire during delivery within the blood vessel or channel is reduced. Real-time acquisition of the guidewire delivery speed is achieved through a speed sensor, combined with Savitzky-Golay filtering and sliding window least squares fitting, accurate real-time speed data is obtained, allowing for dynamic determination of whether resistance adjustment is necessary. The control device can automatically adjust the forward and reverse rotation and rotation angle of the torque motor based on speed changes, achieving real-time adaptive control of the guidewire resistance and ensuring the continuity and stability of the guidewire delivery process. The DBSCAN clustering method is used to analyze historical torque motor rotation data and guidewire motion characteristic data, selecting the most suitable rotation angle from the clustering results to achieve precise torque motor control. Based on the initial rotation angle value corrected for similarity, the resistance adjustment accuracy is further optimized, making the guidewire delivery resistance more consistent with actual working conditions, thereby ensuring the stability of the guidewire entry speed and preventing lumen rupture due to excessive guidewire entry speed. Attached Figure Description

[0040] Various other advantages and benefits will become apparent to those skilled in the art upon reading the following detailed description of preferred embodiments. The accompanying drawings are for illustrative purposes only and are not intended to limit the invention. Furthermore, the same reference numerals denote the same parts throughout the drawings. In the drawings:

[0041] Figure 1 This is a schematic diagram of the spiral guide wire device provided in an embodiment of the present invention;

[0042] Figure 2 A schematic diagram of the engagement between the helical guide wire device cylinder and the extrusion ring provided in an embodiment of the present invention. Figure 1 ;

[0043] Figure 3 A schematic diagram of the engagement between the helical guide wire device cylinder and the extrusion ring provided in an embodiment of the present invention. Figure 2 ;

[0044] Figure 4 A flowchart of a resistance adjustment method for a spiral guide wire device provided in an embodiment of the present invention.

[0045] The components are: 1. Guide wire body; 11. Spiral groove; 12. Wire core; 13. Spiral outer skin; 2. Extrusion device; 21. Cylinder; 211. Extrusion block; 212. Elastic component; 22. Extrusion ring; 221. Extrusion ball; 23. Speed ​​sensor; 24. Torque motor; 25. Support; 26. Transmission chain; 3. Control device. Detailed Implementation

[0046] Exemplary embodiments of the present disclosure will now be described in more detail with reference to the accompanying drawings. While exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure may be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided to enable a more thorough understanding of the present disclosure and to fully convey the scope of the disclosure to those skilled in the art. It should be noted that, unless otherwise specified, embodiments and features in the embodiments of the present invention can be combined with each other. The present invention will now be described in detail with reference to the accompanying drawings and embodiments.

[0047] In some embodiments of this application, see Figure 1-3 As shown, a spiral guide wire device is proposed, comprising: a guide wire body 1, a compression device 2, a control device 3, and a base 4;

[0048] The guidewire body 1 includes a wire core 12 and a spiral outer skin 13. The wire core 12 is made of metal, and the spiral outer skin 13 is a PTFE coating. The surface of the spiral outer skin 13 has spiral grooves 11. The end of the guidewire body 1 is a soft end, and the surface of the soft end is provided with a hydrophilic coating.

[0049] The extrusion device 2 is used to extrude the guide wire body 1, and includes a cylinder 21, an extrusion ring 22, a speed sensor 23, and a torque motor 24. The cylinder 21 is fixed on the base 4 by a bracket 25. The extrusion ring 22 is sleeved on the outside of the cylinder 21 and is rotatably connected relative to the axis of the cylinder 21. The torque motor 24 drives the extrusion ring to rotate through a transmission chain 26. An extrusion ball 221 is provided inside the extrusion ring 22. The cylinder 21 is provided with an extrusion block 211 that cooperates with the extrusion ball 221. The cylinder 21 is also provided with an elastic component 212 for compressing force. The two ends of the elastic component 212 are respectively connected to the cylinder 21 and the extrusion block 211. The speed sensor 23 is located at the outlet of the cylinder 21 and is used to collect the speed value when the guide wire body 1 is delivered.

[0050] The control device 3 is electrically connected to the speed sensor 23 and the torque motor 24. The control device 3 collects the speed value of the speed sensor 23 and dynamically adjusts the forward and reverse rotation of the torque motor 24 based on the speed value to dynamically adjust the resistance of the guide wire body 1.

[0051] It is also equipped with an outer shell to completely cover and protect the guidewire body 1, the extrusion device 2, the control device 3, and the base 4. The outer shell is made of lightweight metal or high-strength engineering plastic, and its outer surface is provided with anti-slip texture so that the operator can hold it stably during guidewire delivery; the interior of the outer shell forms an installation cavity, and the installation cavity is provided with several fixing seats for fixing the base. The two sides of the outer shell are also provided with holes for the guidewire body to extend into and out.

[0052] Specifically, the guidewire body 1 includes a wire core 12 and a spiral outer sheath 13. The wire core 12 is made of high-strength metal material to ensure the rigidity and bending resistance of the guidewire during delivery. The spiral outer sheath 13 is a polytetrafluoroethylene (PTFE) coating layer with a low coefficient of friction, thereby reducing the frictional resistance between the guidewire and the blood vessel wall or lumen during delivery. Continuous spiral grooves 11 are formed on the surface of the spiral outer sheath 13, which facilitate the flexibility and controllability of the guidewire body during delivery. The tip of the guidewire body 1 is a soft tip made of flexible material, and its surface is coated with a hydrophilic coating to reduce friction when encountering liquid environments, improving the smoothness and safety of the guidewire entering the blood vessel or channel. The compression device 2 is used to compress and adjust the resistance of the guidewire body 1, and includes a cylinder 21, a compression ring 22, a speed sensor 23, and a torque motor 24. The cylinder 21 is fixedly mounted on the base 4 by a bracket 25 to ensure the stability of the overall structure. An extrusion ring 22 is fitted around the outside of the cylinder 21 and is rotatably connected to the axis of the cylinder 21. A torque motor 24 is connected to the extrusion ring 22 via a transmission chain 26, thereby driving the extrusion ring 22 to rotate. An extrusion ball 221 is provided inside the extrusion ring 22, and an extrusion block 211 that cooperates with the extrusion ball 221 is provided at a corresponding position on the cylinder 21. The cylinder 21 also has an elastic component 212 with compressive force. The two ends of the elastic component 212 are connected to the cylinder 21 and the extrusion block 211 respectively, providing elastic restoring force during the extrusion process to ensure stable extrusion force. A speed sensor 23 is installed at the outlet of the cylinder 21 to collect the speed value of the guide wire body 1 during delivery in real time. A control device 3 is electrically connected to the speed sensor 23 and the torque motor 24. The control device 3 collects the speed value from the speed sensor 23 and controls the torque motor 24 to rotate forward or backward based on this speed value, thereby dynamically adjusting the resistance of the extrusion device 2 to the guide wire body 1 and achieving intelligent control of resistance. The device also includes an outer shell to completely enclose and protect the guide wire body 1, the extrusion device 2, the control device 3, and the base 4. The shell is made of lightweight metal or high-strength engineering plastic, ensuring structural strength while reducing overall weight for easy operator handling. The outer surface of the shell features ergonomically designed anti-slip textures to provide a stable grip during guide wire delivery, preventing slippage. An internal mounting cavity contains several fixing seats to secure the base 4 and extrusion device 2, preventing displacement of internal components due to vibration or external forces during use. Symmetrical guide wire holes are located on both sides of the shell, allowing the guide wire body 1 to extend or retract. The edges of the holes are rounded to prevent scratching of the guide wire during insertion and removal.

[0053] During operation, the operator first confirms that the guidewire body 1 is clean and uncontaminated; checks whether the soft tip of the guidewire body 1 is intact and the hydrophilic coating is undamaged; inserts the free end of the guidewire body 1 through the hole on the side of the outer shell, passes through the cylinder 21, and engages with the compression device 2. Connects the control device 3 to the power supply and checks whether the signal interface and speed sensor 23 are normal; after the control device 3 is initialized, it drives the torque motor 24, which in turn drives the compression ring 22 and compression ball 221 to rotate, compressing the compression block 211 and establishing initial contact pressure between the compression block 211 and the guidewire body 1. The operator uses the outer shell holding device to gradually insert the guidewire body 1 into the target lumen or blood vessel; during delivery, the guidewire body 1 maintains contact with the inner wall of the cylinder 21 and the compression block 211, and the compression device 2 applies controllable resistance to the guidewire; the speed sensor 23 collects the guidewire delivery speed in real time and transmits the signal to the control device 3. Based on the data collected by the speed sensor 23, the control device 3 determines whether the guide wire delivery is too fast, too slow, or stuck. When the guide wire speed exceeds the preset range, the control device 3 adjusts the rotation direction and speed of the torque motor 24, driving the compression ring 22 to rotate. The compression ring 22 drives the compression ball 221 to cooperate with the compression block 211, compressing and changing the friction force on the guide wire body 1, thereby dynamically adjusting the resistance and ensuring a stable and safe guide wire delivery speed. When the guide wire reaches the predetermined position, the operator can stop delivery. The control device 3 keeps the motor stable, and the compression device 2 continues to provide appropriate resistance to fix the guide wire and prevent it from retracting or shifting position.

[0054] Understandably, the guidewire body's composite structure of a metal wire core and a PTFE spiral outer sheath, with spiral grooves on the outer sheath surface, effectively reduces frictional resistance within the blood vessel lumen, improving its flexibility and passability. Combined with a hydrophilic coating on the soft tip, this facilitates smoother guidewire delivery through complex vascular pathways, reducing the risk of vascular injury. By incorporating a compression device, speed sensor, and control device, speed parameters can be collected in real-time during guidewire delivery, and the forward and reverse rotation of the torque motor can be dynamically adjusted. This regulates the frictional force of the compression ring on the guidewire, achieving dynamic adjustment of guidewire resistance and preventing slippage or jamming due to excessive or insufficient resistance.

[0055] In another preferred embodiment based on the above embodiments, see [reference] Figure 4 As shown, this embodiment provides a resistance adjustment method for a spiral guide wire device, used in applying the above-mentioned spiral guide wire device, including:

[0056] The velocity values ​​of the velocity sensor are acquired in real time based on the Savitzky-Golay filtering method. The velocity values ​​are compared with the velocity threshold to determine whether the resistance value of the guidewire body needs to be adjusted.

[0057] When it is determined that the resistance value needs to be adjusted, the torque motor rotation scheme is determined, and the torque motor rotation angle value is selected from the determined torque motor rotation scheme based on DBSCAN clustering; the torque motor is adjusted based on the torque motor rotation angle value.

[0058] The resistance of the guide wire body is dynamically adjusted by regulating the rotation direction and angle of the torque motor.

[0059] Specifically, the velocity sensor continuously acquires instantaneous velocity data of the guidewire body during delivery at a fixed sampling frequency, and stores the acquired data in a circular buffer in real time to ensure data continuity and real-time performance. Subsequently, the control device smooths the sliding window data formed by each new sampling point and several sampling points before and after it using the Savitzky-Golay filtering method. A low-order polynomial is fitted using the least squares method, and the fitted velocity value at the center point of the window is calculated as the actual velocity of the guidewire at the current moment, effectively reducing noise interference and preserving the true motion characteristics of the guidewire. Next, the filtered velocity value is compared with a preset velocity threshold. Based on the velocity judgment result, the control device determines the rotation scheme of the torque motor, including a forward rotation scheme to increase resistance and a reverse rotation scheme to reduce resistance, while generating candidate rotation angles and corresponding feature data, including guidewire motion characteristics and torque motor characteristics. Then, the candidate angles and historical data sets are integrated to form a clustering dataset, which is standardized and clustered using the DBSCAN clustering algorithm to identify core points, boundary points, and noise points in the dataset, thus forming several stable rotation angle clusters. Based on the clustering results, the control device selects the optimal rotation angle value. Finally, the control device drives the torque motor to operate according to the selected rotation angle and direction, and adjusts the pressure of the guide wire body through the extrusion ring and extrusion ball to achieve dynamic adjustment of the guide wire resistance. Throughout the process, the guide wire speed is continuously monitored in real time, and the rotation angle and direction of the torque motor are cyclically adjusted according to the real-time speed changes to control the guide wire entry speed and achieve closed-loop control.

[0060] Understandably, by monitoring the guidewire speed in real time using a speed sensor and smoothing the data using the Savitzky-Golay filtering method, noise interference is effectively eliminated, resulting in accurate guidewire speed information. The control device determines whether resistance adjustment is needed based on the speed threshold, enabling smooth guidewire advancement within the blood vessel or channel and reducing the risk of guidewire entrapment or slippage. Real-time dynamic control of guidewire resistance is achieved through the forward and reverse rotation and angle adjustment of the torque motor. DBSCAN cluster analysis of historical rotation data and current feature data automatically selects the optimal rotation angle, avoiding erroneous adjustments due to single abnormal data points and improving the stability and reliability of resistance adjustment.

[0061] In some embodiments of this application, when acquiring the velocity values ​​of the velocity sensor in real time based on the Savitzky–Golay filtering method, the following steps are included:

[0062] The speed sensor continuously outputs speed data streams at a fixed sampling frequency and stores the speed data streams in a circular buffer in real time; it automatically extracts a sliding window of each new sampling point and several adjacent sampling points before and after it; within the sliding window, it fits a low-order polynomial based on the least squares method and uses the function value of the low-order polynomial at the center point of the window as the speed value at the current moment.

[0063] Specifically, the velocity sensor continuously collects instantaneous velocity data of the guidewire body at a fixed sampling frequency and stores the collected velocity data in real time in a circular buffer to ensure that the latest data overwrites the oldest data, achieving continuous updates and real-time storage. Subsequently, for each new sampling point, several adjacent sampling points are automatically extracted to form a sliding window. For example, the window length can be set to 5 to 11 sampling points to ensure that the calculation of the current velocity not only refers to the current sampling point but also takes into account surrounding historical and neighboring data, smoothing instantaneous fluctuations. Next, within the sliding window, the control device fits a low-order polynomial (such as a second- or third-order polynomial) using the least squares method. By calculating the coefficients of the fitted polynomial, the squared error between the actual velocity values ​​and the fitted values ​​of all sample points within the window is minimized, thereby obtaining the best fitting curve. After fitting, the function value of the polynomial at the center point of the sliding window is taken as the guidewire velocity value at the current moment. This velocity value can eliminate the interference of sensor noise on the data and accurately reflect the motion state of the guidewire body at that moment. The filtered speed value is then transmitted to the control device to determine whether the guidewire resistance needs adjustment and further to determine the rotation direction and angle of the torque motor, achieving closed-loop dynamic control. As new speed sampling points continuously arrive, the sliding window moves forward continuously, repeating the above process to achieve continuous, real-time filtering and output of speed data, providing reliable and accurate input data for guidewire resistance adjustment.

[0064] For example, during guidewire delivery, a velocity sensor continuously collects instantaneous velocity data of the guidewire body at a fixed sampling frequency and stores the collected data in a circular buffer in real time. For each new sampling point, a sliding window is formed by extracting several adjacent sampling points before and after it. Within the window, a second- or third-order polynomial is fitted using the least squares method, and the function value of the polynomial at the center point is calculated as the filtered velocity value for the current moment. If the continuously collected velocity data are 4.0, 4.2, 3.8, 4.5, and 4.1 mm / s, then the velocity at the center point after fitting within the window is 4.08 mm / s.

[0065] Understandably, by using a sliding window and low-order polynomial fitting, sensor noise and instantaneous fluctuations are effectively filtered out, resulting in smoother and more stable guidewire speed measurements that accurately reflect the guidewire's motion. Continuous acquisition of speed data at a fixed sampling frequency and real-time updates to the annular buffer enable continuous monitoring of the guidewire speed, ensuring the control device can obtain the latest speed information instantly. The filtered speed value serves as input for resistance judgment and torque motor adjustment, ensuring that resistance adjustment is based on accurate speed information and avoiding erroneous adjustments caused by noise or transient abnormal data.

[0066] In some embodiments of this application, fitting low-order polynomial values ​​based on the least squares method includes:

[0067] Collect all data points within the sliding window and select several adjacent data points as sample points; construct the corresponding polynomial function according to the set order of the fitting polynomial; calculate the coefficients of the polynomial function based on the sample points using the least squares method, and minimize the sum of squared errors between the actual values ​​of the sample points and the fitted values; fit the data points within the window interval according to the polynomial function to obtain the low-order polynomial values.

[0068] Specifically, all velocity data points within the sliding window are collected, and several adjacent sampling points are selected as fitting sample points to ensure that the fitting considers both the current velocity and surrounding historical and neighboring data, avoiding the influence of single-point noise on the results. Subsequently, a corresponding polynomial function is constructed based on a pre-set polynomial order (usually second or third order). The least squares method is used to calculate the selected sample points, and the polynomial coefficients that minimize the sum of squared errors between the actual values ​​of the sample points and the fitted polynomial values ​​are solved to obtain the best-fit curve. After fitting, this polynomial function is applied to all data points within the sliding window to predict the velocity at each point, obtaining a smoothed low-order polynomial value. This smoothed velocity value eliminates sensor noise interference and accurately reflects the guidewire's motion state at the current moment, providing a reliable basis for subsequent resistance judgment and torque motor adjustment.

[0069] Understandably, the combination of the sliding window and the least squares method enables continuous fitting and real-time updating of speed data, providing reliable speed input to the control device and ensuring timely response of dynamic resistance adjustment. The filtered low-order polynomial value can be used as a reference to determine whether the guide wire resistance is too high or too low, improving the accuracy of torque motor adjustment and avoiding malfunctions caused by noise or abnormal data.

[0070] In some embodiments of this application, when comparing a speed value with a speed threshold to determine whether the resistance value of the guidewire body needs to be adjusted, the following steps are included:

[0071] The speed threshold includes a first speed threshold and a second speed threshold; the first speed threshold is less than the second speed threshold.

[0072] When the speed value is less than or equal to the first speed threshold, it is determined that the resistance value of the guidewire body needs to be reduced.

[0073] When the speed value is greater than the first speed threshold and less than the second speed threshold, it is determined that the resistance value of the guidewire body does not need to be adjusted.

[0074] When the speed value is greater than or equal to the second speed threshold, it is determined that the resistance value of the guidewire body needs to be increased.

[0075] Specifically, after obtaining the filtered guidewire velocity value, this velocity value is compared with a preset velocity threshold to determine whether the guidewire resistance needs adjustment. Specifically, the velocity threshold includes a first velocity threshold and a second velocity threshold, where the first velocity threshold is less than the second velocity threshold. For example, let the first velocity threshold be 4.5 mm / s and the second velocity threshold be 6.0 mm / s. If the current filtered velocity value is less than or equal to the first velocity threshold, such as 4.0 mm / s, the guidewire resistance is determined to be too high and needs to be reduced; if the current velocity value is between the first and second velocity thresholds, such as 5.2 mm / s, the guidewire resistance is determined to be within the normal range and no adjustment is needed; if the current velocity value is greater than or equal to the second velocity threshold, such as 6.2 mm / s, the guidewire resistance is determined to be too low and needs to be increased.

[0076] Understandably, by setting first and second speed thresholds, it is possible to clearly determine whether the guidewire resistance is too high, too low, or normal, thereby allowing for targeted adjustments to the torque motor and improving the accuracy of resistance control. The ability to dynamically judge the resistance state based on real-time speed prevents the guidewire from getting stuck due to excessive resistance or going out of control due to insufficient resistance during delivery, achieving smooth advancement. Precise resistance control reduces the risk of friction and damage to the guidewire in complex channels or blood vessels, improving operational safety. Through dual-threshold judgment, the control device adjusts the torque motor only when necessary, avoiding frequent ineffective operations and improving the overall response efficiency and reliability of guidewire delivery.

[0077] In some embodiments of this application, when it is determined that the resistance value needs adjustment, the torque motor rotation scheme is determined as follows:

[0078] Torque motor rotation schemes include forward rotation and reverse rotation schemes.

[0079] When it is necessary to reduce the resistance value of the guide wire body, the torque motor reversal scheme is adopted.

[0080] When it is necessary to increase the resistance value of the guide wire body, the forward rotation scheme of the torque motor is adopted.

[0081] Specifically, if the speed value is lower than the first speed threshold, it is determined that the guide wire resistance is too high and needs to be reduced. In this case, the control device selects the reverse rotation scheme of the torque motor, causing the extrusion ring to rotate in the opposite direction to the guide wire's movement. This slight reverse rotation of the extrusion ring and extrusion ball reduces the pressure between the guide wire and the extrusion block, thereby reducing the frictional resistance of the guide wire within the cylinder and allowing the guide wire delivery speed to return to a reasonable range. If the speed value is higher than the second speed threshold, it is determined that the guide wire resistance is too low and needs to be increased. In this case, the control device selects the forward rotation scheme of the torque motor, causing the extrusion ring to rotate in the direction of the guide wire's movement. Forward rotation increases the pressure of the extrusion ring on the guide wire, thereby increasing the frictional resistance of the guide wire within the cylinder and causing the guide wire delivery speed to decrease to a reasonable range.

[0082] Understandably, by directly adjusting the pressure of the compression ring on the guide wire through forward or reverse rotation, the guide wire resistance can be changed instantly, achieving a rapid response to speed changes. Selecting the appropriate rotation scheme based on the speed threshold ensures the correct direction of resistance adjustment, effectively preventing abnormal guide wire speed caused by over-adjustment or incorrect direction.

[0083] In some embodiments of this application, when selecting the torque motor rotation angle value based on DBSCAN clustering from the determined torque motor rotation scheme, the following is included:

[0084] Obtain all rotation angle values ​​and corresponding feature data of the torque motor rotation scheme, and construct a historical data set; the feature data includes torque motor feature data and guide wire motion feature data; standardize the rotation angle and feature data in the historical data set; integrate the historical data set with the data set constructed from the current feature data to form a set to be clustered;

[0085] The set to be clustered is clustered according to DBSCAN clustering, and the rotation angle value is determined based on the clustering results.

[0086] Specifically, when the guidewire resistance needs adjustment and the torque motor rotation scheme has been determined, the DBSCAN clustering method is used to intelligently select the torque motor's rotation angle. The process involves first acquiring historical operational data, including the rotation angle and related feature data for each rotation scheme. Feature data includes torque motor speed, power, and real-time guidewire speed and resistance values, and this data is used to construct a historical dataset. Next, the historical dataset is integrated with the currently acquired feature data to form a clustering set, and all feature data is standardized to eliminate dimensional differences. Then, the DBSCAN algorithm is used to perform cluster analysis on the clustering set to identify core clusters similar to the current operational state.

[0087] Understandably, by combining historical experience data with real-time feature information, the optimal rotation angle is intelligently selected, making guidewire resistance adjustment more precise and avoiding speed fluctuations or excessive friction caused by fixed angle adjustments. DBSCAN clustering can identify the similarity between the current guidewire state and historical data, enabling adaptive adjustment to different operating environments and guidewire states. Utilizing historical data and real-time analysis to automatically determine the rotation angle reduces the frequency and complexity of manual adjustments by operators, thus lowering operational risks.

[0088] In some embodiments of this application, clustering the set to be clustered according to DBSCAN clustering, and determining the rotation angle value based on the clustering results, includes:

[0089] S1: For each data point, determine the set of its neighboring points within its ε-neighborhood;

[0090] S2: If the number of neighboring points is greater than or equal to the preset minimum number of neighbors minPts, then mark the data point as a core point and add the points in its neighborhood to the same cluster;

[0091] S3: Repeat S1 and S2 for the new core points within the cluster until the cluster expansion is complete;

[0092] S4: When the cluster containing the dataset does not contain historical datasets, the historical rotation angle value corresponding to the maximum similarity between the dataset and the historical dataset is selected as the initial rotation angle value; when the cluster containing the dataset contains historical datasets, the average of the historical rotation angle values ​​corresponding to all the included historical datasets is selected as the rotation angle value.

[0093] Specifically, when the guidewire resistance needs adjustment, the system first collects characteristic data such as the current guidewire speed and force, and integrates this data with historical operation data to form a cluster set. Then, the DBSCAN algorithm is used to perform cluster analysis on this set: for each data point, the number of neighboring points within its radius ε is determined, and data points with a neighbor count reaching a preset minimum value minPts are marked as core points, and points within their neighborhoods are added to the same cluster. This process is repeated for new core points within a cluster until the cluster expansion is complete. After clustering, if the current data's cluster contains historical data, the average of all historical rotation angles within the cluster is taken as the current torque motor's rotation angle; if it does not contain historical data, the rotation angle with the highest similarity to historical data is selected as the initial value, and fine-tuned based on the similarity.

[0094] Understandably, by combining historical data with real-time characteristics, precise control of guidewire resistance is achieved, avoiding excessive friction or speed fluctuations caused by fixed or experience-based adjustments. It can identify the similarity between the current operating state and historical experience, automatically selecting the optimal rotation angle to adapt to different guidewire conditions and operating environments.

[0095] In some embodiments of this application, when selecting the historical rotation angle value corresponding to the maximum similarity between the data set and the historical data set as the initial rotation angle value, the following methods are included:

[0096] The similarity coefficient between the dataset and the historical dataset is calculated based on the Euclidean distance algorithm. The similarity coefficient is then used as a correction coefficient to correct the initial rotation angle value, which is then used as the rotation angle value.

[0097] In some embodiments of this application, when calculating the similarity coefficient between the dataset and the historical dataset based on the Euclidean distance algorithm, the following steps are included:

[0098] The feature data that maximizes the similarity between the dataset and the historical dataset is determined and standardized. For each pair of corresponding data in the feature data, the difference is calculated and squared. The squared differences of all data are summed to obtain the overall difference value. The square root of the overall difference value is then calculated to obtain the Euclidean distance between the dataset and the historical dataset in the multidimensional feature space. The Euclidean distance is normalized according to the maximum and minimum distances of all data. Finally, the similarity coefficient is obtained by subtracting the normalized Euclidean distance from 1.

[0099] Specifically, all feature data (including torque motor features and guide wire motion features) in the current and historical datasets are standardized to make the data from different dimensions comparable and eliminate the impact of dimensional differences on distance calculation. The difference between each historical sample in the current and historical datasets is calculated dimension-wise, and the squared differences are summed and then the square root is taken to obtain the Euclidean distance in the multidimensional feature space. Among all historical samples, the sample with the smallest Euclidean distance is selected, i.e., the data point with the highest similarity to the current dataset. The smallest Euclidean distance is normalized (e.g., normalized according to the range between the maximum and minimum values), and the normalized distance value is subtracted from 1 to obtain the similarity coefficient. The closer the similarity coefficient is to 1, the more similar the current data is to the historical data. The selected historical rotation angle value is used as the initial value, and the similarity coefficient is multiplied or added to the initial angle as a correction coefficient to fine-tune the initial rotation angle to better match the current data features. The corrected angle is the final rotation angle value used by the torque motor to perform rotation operations.

[0100] Understandably, by calculating the Euclidean distance between the current and historical data sets in the multidimensional feature space, similarity can be accurately assessed, making the initial rotation angle of the torque motor closer to actual needs. Using a similarity coefficient to correct the initial angle allows for automatic fine-tuning of the rotation angle based on the current guidewire state, achieving intelligent adjustment without manual intervention. Combining historical data and real-time acquired features fully leverages existing experience, improving the reliability of torque motor control while adapting to real-time changes in the guidewire state.

[0101] For example, during guidewire delivery, the torque motor has accumulated historical rotation angle data and corresponding feature data (such as guidewire speed, guidewire force, and compression ring speed), forming a historical data set. The feature data collected at the current moment regarding the guidewire's motion state are: instantaneous guidewire speed: 0.85 m / s, guidewire force: 1.2 N, compression ring speed: 150 rpm. The historical data set (e.g., the past 100 sets of data) and the current moment's feature data are integrated into a clustering set. Each feature data is standardized to make data of different dimensions comparable. Parameters are set: ε = 0.2 (neighborhood radius), minPts = 5 (minimum number of neighbors). Clustering is performed on the clustering set, and the current data set is found to fall into a new cluster containing 3 sets of historical data. The Euclidean distance between the current data and the historical data in the cluster is calculated, and the rotation angle corresponding to the historical data with the highest similarity to the current data is selected as the initial rotation angle. For example, the historical rotation angle of the data with the highest similarity is 30°. The similarity coefficient is calculated based on Euclidean distance: Assuming the normalized Euclidean distance is 0.2, the similarity coefficient = 1 - 0.2 = 0.8. Multiplying the initial rotation angle of 30° by the correction factor 0.8 yields the corrected rotation angle = 30° × 0.8 = 24°. Based on the corrected angle of 24°, the torque motor is controlled to rotate forward or backward, thus dynamically adjusting the guide wire resistance.

[0102] In summary, by incorporating a soft tip and hydrophilic coating at the guidewire end, and designing the PTFE-coated outer surface of the guidewire with helical grooves, the frictional resistance during guidewire delivery within the blood vessel or channel was reduced. Real-time guidewire delivery speed was acquired using a speed sensor, and Savitzky-Golay filtering and sliding window least squares fitting were combined to accurately obtain real-time speed data, allowing for dynamic determination of resistance adjustment needs. The control device automatically adjusts the forward and reverse rotation and rotation angle of the torque motor based on speed changes, achieving real-time adaptive control of guidewire resistance and ensuring the continuity and stability of the guidewire delivery process. The DBSCAN clustering method was used to analyze historical torque motor rotation data and guidewire motion characteristic data, selecting the most suitable rotation angle from the clustering results to achieve precise torque motor control. Based on the initial rotation angle value corrected for similarity, the resistance adjustment accuracy was further optimized, making the guidewire delivery resistance more consistent with actual working conditions, thus ensuring the stability of the guidewire entry speed and preventing lumen rupture due to excessive guidewire entry speed.

[0103] Those skilled in the art will understand that embodiments of this application can be provided as methods, systems, or computer program goods. Therefore, this application can take the form of a completely hardware embodiment, a completely software embodiment, or an embodiment combining software and hardware aspects. Furthermore, this application can take the form of a computer program goods embodied on one or more computer-usable storage media (including, but not limited to, disk storage, CD-ROM, optical storage, etc.) containing computer-usable program code.

[0104] This application is described with reference to flowchart illustrations and / or block diagrams of methods, apparatus (systems), and computer program goods according to embodiments of this application. It will be understood that each block of the flowchart illustrations and / or block diagrams, and combinations of blocks in the flowchart illustrations and / or block diagrams, can be implemented by computer program instructions. These computer program instructions can be provided to a processor of a general-purpose computer, special-purpose computer, embedded processor, or other programmable data processing apparatus to produce a machine, such that the instructions, which execute via the processor of the computer or other programmable data processing apparatus, generate instructions for implementing the flowchart... Figure 1 One or more processes and / or boxes Figure 1 A device that provides the functions specified in one or more boxes.

[0105] These computer program instructions may also be stored in a computer-readable storage medium that can direct a computer or other programmable data processing device to function in a particular manner, such that the instructions stored in the computer-readable storage medium produce an article of manufacture including instruction means, which are implemented in a process Figure 1 One or more processes and / or boxes Figure 1 The function specified in one or more boxes.

[0106] These computer program instructions may also be loaded onto a computer or other programmable data processing equipment to cause a series of operational steps to be performed on the computer or other programmable equipment to produce a computer-implemented process, thereby providing instructions that execute on the computer or other programmable equipment for implementing the process. Figure 1 One or more processes and / or boxes Figure 1 The steps of the function specified in one or more boxes.

[0107] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and not to limit it. Although the present invention has been described in detail with reference to the above embodiments, those skilled in the art should understand that modifications or equivalent substitutions can still be made to the specific implementation of the present invention. Any modifications or equivalent substitutions that do not depart from the spirit and scope of the present invention should be covered within the scope of protection of the claims of the present invention.

Claims

1. A method for adjusting the resistance of a spiral guide wire device, characterized in that, The spiral guide wire device includes: a guide wire body, a compression device, a control device, and a base; The guidewire body includes a wire core and a spiral outer sheath. The wire core is made of metal, and the spiral outer sheath is a PTFE coating layer. The surface of the spiral outer sheath has spiral grooves. The end of the guidewire body is a soft tip, and the surface of the soft tip is provided with a hydrophilic coating. The extrusion device is used to extrude the guide wire body and includes a cylinder, an extrusion ring, a speed sensor, and a torque motor. The cylinder is fixed to the base by a bracket. The extrusion ring is sleeved on the outside of the cylinder and rotatably connected relative to the axis of the cylinder. The torque motor drives the extrusion ring to rotate through a transmission chain. An extrusion ball is provided inside the extrusion ring. The cylinder is provided with an extrusion block that cooperates with the extrusion ball. The cylinder is also provided with an elastic component for compressing force. The two ends of the elastic component are respectively connected to the cylinder and the extrusion block. The speed sensor is located at the outlet of the cylinder and is used to collect the speed value when the guide wire body is delivered. The control device is electrically connected to the speed sensor and the torque motor; the control device collects the speed value of the speed sensor and dynamically controls the forward and reverse rotation of the torque motor based on the speed value to dynamically adjust the resistance of the guide wire body; The resistance adjustment method of the spiral guidewire device includes: real-time acquisition of the speed value of the speed sensor based on the Savitzky-Golay filtering method, comparing the speed value with the speed threshold, and determining whether it is necessary to adjust the resistance value of the guidewire body; When it is determined that the resistance value needs to be adjusted, a torque motor rotation scheme is determined, and a torque motor rotation angle value is selected from the determined torque motor rotation scheme based on DBSCAN clustering; the torque motor is adjusted based on the torque motor rotation angle value. The resistance of the guide wire body is dynamically adjusted by regulating the rotation direction and angle of the torque motor.

2. The resistance adjustment method of the spiral guide wire device according to claim 1, characterized in that, When acquiring velocity values ​​from a velocity sensor in real time using the Savitzky–Golay filtering method, the following are included: The speed sensor continuously outputs a speed data stream at a fixed sampling frequency and stores the speed data stream in a circular buffer in real time; it automatically extracts a sliding window of each new sampling point and several adjacent sampling points before and after it; within the sliding window, it fits a low-order polynomial based on the least squares method and uses the function value of the low-order polynomial at the center point of the window as the speed value at the current moment.

3. The resistance adjustment method of the spiral guide wire device according to claim 2, characterized in that, When fitting low-order polynomial values ​​using the least squares method, the following are included: Collect all data points within the sliding window and select several adjacent data points as sample points; construct the corresponding polynomial function according to the set order of the fitting polynomial; calculate the coefficients of the polynomial function using the least squares method based on the sample points, and minimize the sum of squared errors between the actual values ​​and the fitted values ​​of the sample points; fit the data points within the window interval according to the polynomial function to obtain the low-order polynomial values.

4. The resistance adjustment method of the spiral guide wire device according to claim 3, characterized in that, When comparing the speed value with the speed threshold to determine whether the resistance value of the guidewire body needs to be adjusted, the following steps are included: The speed threshold includes a first speed threshold and a second speed threshold; the first speed threshold is smaller than the second speed threshold. When the speed value is less than or equal to the first speed threshold, it is determined that the resistance value of the guidewire body needs to be reduced. When the speed value is greater than the first speed threshold and less than the second speed threshold, it is determined that the resistance value of the guidewire body does not need to be adjusted. When the speed value is greater than or equal to the second speed threshold, it is determined that the resistance value of the guidewire body needs to be increased.

5. The resistance adjustment method of the spiral guide wire device according to claim 4, characterized in that, When it is determined that the resistance value needs adjustment, the torque motor rotation scheme is determined as follows: The torque motor rotation scheme includes a forward rotation scheme and a reverse rotation scheme. When it is necessary to reduce the resistance value of the guide wire body, the torque motor reversal scheme is adopted. When it is necessary to increase the resistance value of the guide wire body, the forward rotation scheme of the torque motor is adopted.

6. The resistance adjustment method of the spiral guide wire device according to claim 5, characterized in that, When selecting the torque motor rotation angle value based on the determined torque motor rotation scheme using DBSCAN clustering, the process includes: Obtain all rotation angle values ​​and corresponding feature data of the torque motor rotation scheme, and construct a historical data set; the feature data includes torque motor feature data and guide wire motion feature data; standardize the rotation angles and feature data in the historical data set; integrate the historical data set with the data set constructed from the current feature data to form a clustering set; The set to be clustered is clustered using DBSCAN clustering, and the rotation angle value is determined based on the clustering results.

7. The resistance adjustment method of the spiral guide wire device according to claim 6, characterized in that, When clustering the set to be clustered using DBSCAN clustering, and determining the rotation angle value based on the clustering results, the following steps are included: S1: For each data point, determine the set of its neighboring points within its ε-neighborhood; S2: If the number of neighboring points is greater than or equal to the preset minimum number of neighbors minPts, then mark the data point as a core point and add the points in its neighborhood to the same cluster; S3: Repeat S1 and S2 for the new core points within the cluster until the cluster expansion is complete; S4: When the cluster containing the data set does not contain a historical data set, the historical rotation angle value corresponding to the maximum similarity between the data set and the historical data set is selected as the initial rotation angle value; when the cluster containing the data set contains a historical data set, the average value of the historical rotation angle values ​​corresponding to all the historical data sets contained therein is selected as the rotation angle value.

8. The resistance adjustment method of the spiral guide wire device according to claim 7, characterized in that, When selecting the historical rotation angle value corresponding to the maximum similarity between the dataset and the historical dataset as the initial rotation angle value, the following are included: The similarity coefficient between the dataset and the historical dataset is calculated using the Euclidean distance algorithm. The similarity coefficient is then used as a correction coefficient to correct the initial rotation angle value, which is then used as the final rotation angle value.

9. The resistance adjustment method of the spiral guide wire device according to claim 8, characterized in that, When calculating the similarity coefficient between the dataset and the historical dataset using the Euclidean distance algorithm, the following steps are included: The feature data that has the maximum similarity between the data set and the historical data set is determined, and the feature data is standardized. The difference between each pair of corresponding data in the feature data is calculated, and the difference is squared. The squared differences of all data are summed to obtain the overall difference value. The square root of the overall difference value is then calculated to obtain the Euclidean distance between the data set and the historical data set with the maximum similarity in the multidimensional feature space. The Euclidean distance is normalized according to the maximum and minimum distances of all data. The similarity coefficient is obtained by subtracting the normalized Euclidean distance from 1.

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