Spiral wire guiding device and resistance adjusting method thereof

Abstract

The invention relates to the technical field of medical instruments, and discloses a spiral guide wire device and a resistance adjusting method thereof.The spiral guide wire device comprises a guide wire body, the guide wire body comprises a wire core and a spiral outer skin, and the spiral outer skin is a PTFE coating layer and provided with a spiral groove; the extrusion device is used for extruding the guide wire body and comprises a barrel, an extrusion ring, a speed sensor and a torque motor, the barrel is sleeved with the extrusion ring, the torque motor drives the extrusion ring to rotate through a transmission chain, the barrel is provided with an extrusion block matched with an extrusion ball, and the speed sensor is arranged at an outlet of the barrel and used for collecting the speed value when the guide wire body is delivered; the control device is electrically connected with the speed sensor and the torque motor; and the control device dynamically regulates and controls the forward and reverse rotation of the torque motor based on the speed value by collecting the speed value of the speed sensor, so as to dynamically regulate the resistance of the guide wire body. By dynamically adjusting the resistance of the guide wire, the stability of the entering speed of the guide wire is ensured.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a spiral guidewire device and a resistance adjustment method thereof. Background Art

[0002] In existing guidewire delivery technologies, guidewire devices are widely used in the delivery of vascular guidewires or minimally invasive devices. However, when the guidewire enters the operating channel, the advancement speed of the guidewire itself is often difficult to accurately control. This is especially true in narrow or tortuous areas of the lumen, where uneven acceleration or deceleration of the guidewire can occur, increasing operational risks and compromising positioning accuracy.

[0003] Existing technologies typically rely on the operator to manually adjust the advancement speed, but this method is significantly affected by human factors and cannot achieve stable and repeatable guidewire delivery speed control. Some devices attempt to directly drive the guidewire through a fixed power unit, but this still cannot guarantee stable entry speed when the friction between the guidewire and the tubing varies significantly, and excessively fast guidewire entry can easily lead to lumen rupture.

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

[0005] In view of this, the present invention proposes a spiral guidewire device and a resistance adjustment method thereof, aiming to solve the current problem that the stability of the entry speed cannot be guaranteed and the lumen is easily ruptured due to the excessively fast entry speed of the guidewire.

[0006] In one aspect, the present invention provides a spiral guidewire device, comprising: a guidewire body, an extrusion device, a control device, and a base; The guide wire body comprises a wire core and a spiral outer skin, wherein the wire core is made of metal material, the spiral outer skin is a PTFE coating layer, the surface of the spiral outer skin has spiral grooves, and the end of the guide wire body is a soft tip end, and the surface of the soft tip end is provided with a hydrophilic coating; The extrusion device is used to extrude the guide wire body, and includes a barrel, an extrusion ring, a speed sensor and a torque motor. The barrel is fixed to the base through a bracket, the extrusion ring is sleeved on the outside of the barrel and is rotatably connected relative to the axis of the barrel, the torque motor drives the extrusion ring to rotate through a transmission chain, a squeezing ball is provided inside the squeezing ring, the barrel is provided with an extrusion block that cooperates with the squeezing ball, and the barrel is further provided with an elastic component with compressive force, and the two ends of the elastic component are respectively connected to the barrel and the extrusion block; the speed sensor is provided at the outlet of the barrel, and is used to collect the speed value of the guide wire body during delivery; 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 guidewire body.

[0007] In another aspect, the present invention provides a method for adjusting resistance of a spiral guidewire device, which is used to apply the above-mentioned spiral guidewire device, comprising: The speed value of the speed sensor is collected in real time based on the Savitzky–Golay filtering method, and the speed value is compared with the speed threshold to determine whether the resistance value of the guidewire body needs to be adjusted; 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; and the torque motor is adjusted based on the torque motor rotation angle value; The resistance of the guidewire body is dynamically adjusted by adjusting the rotation direction and rotation angle of the torque motor.

[0008] Furthermore, when the speed value of the speed sensor is collected in real time based on the Savitzky–Golay filtering method, the following steps are included: The speed sensor continuously outputs a speed data stream at a fixed sampling frequency and stores the speed data stream in a ring buffer in real time; automatically intercepts a sliding window of each new sampling point and several adjacent sampling points before and after it; and fits a low-order polynomial within the sliding window based on the least squares method, using the function value of the low-order polynomial at the center point of the window as the speed value at the current moment.

[0009] Furthermore, when fitting low-order polynomial values ​​based on the least squares method, it includes: All data points within the sliding window are collected, and several adjacent data points are selected as sample points; a corresponding polynomial function is constructed according to the set order of the fitting polynomial; based on the sample points, the least squares method is used to calculate the coefficients of the polynomial function to be calculated, and the sum of squares of errors between the actual values ​​of the sample points and the fitted values ​​is minimized; the data points within the window interval are fitted according to the polynomial function to obtain low-order polynomial values.

[0010] Furthermore, when comparing the speed value with the speed threshold and determining whether the resistance value of the guidewire body needs to be adjusted, the method includes: The speed threshold includes a first speed threshold and a second speed threshold; the first speed threshold is less than the second speed threshold; When the speed value is less than or equal to the first speed threshold, determining 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 there is no need to adjust the resistance value of the guidewire body; 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.

[0011] Furthermore, when it is determined that the resistance value needs to be adjusted, determining the torque motor rotation scheme includes: The torque motor rotation scheme includes a torque motor forward rotation scheme and a torque motor reverse rotation scheme; When the resistance value of the guidewire body needs to be reduced, determining to adopt the torque motor reversal solution; When the resistance value of the guidewire body needs to be increased, the torque motor forward rotation solution is determined to be adopted.

[0012] Furthermore, when selecting the torque motor rotation angle value according to the torque motor rotation scheme determined based on DBSCAN clustering, the method includes: Obtain all rotation angle values ​​and corresponding feature data in the torque motor rotation scheme and construct a historical data set; the feature data includes torque motor feature data and guidewire motion feature data; perform standardization on 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 set to be clustered; The cluster set is clustered according to DBSCAN clustering, and the rotation angle value is determined according to the clustering result.

[0013] Furthermore, clustering the set of clusters to be clustered is performed according to DBSCAN clustering, and the rotation angle value is determined according to the clustering result, including: S1: For each data point, determine the set of neighboring points within its ε neighborhood; S2: If the number of neighbor points is greater than or equal to the preset minimum number of neighbors minPts, the data point is marked as a core point, and the points in its neighborhood are added to the same cluster; S3: Repeat S1 and S2 for the new core points in the cluster until the cluster expansion is completed; S4: When the cluster where the data set is located 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 where the data set is located 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.

[0014] 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 method includes: The similarity coefficient of the maximum similarity between the data set and the historical data set is calculated based on the Euclidean distance algorithm, and the similarity coefficient is used as a correction coefficient. The initial rotation angle value is corrected based on the correction coefficient, and the corrected initial rotation angle value is used as the rotation angle value.

[0015] Furthermore, when calculating the similarity coefficient of the maximum similarity between the data set and the historical data set based on the Euclidean distance algorithm, the method includes: Determine the feature data with the maximum similarity between the data set and the historical data set, and standardize the feature data; calculate the difference for each pair of corresponding data in the feature data, square the difference, accumulate the square differences of all data to obtain an overall difference value, and perform a square root operation on the overall difference value to obtain the Euclidean distance of the maximum similarity between the data set and the historical data set in the multidimensional feature space, normalize the Euclidean distance according to the maximum and minimum values ​​of all data distances, and then subtract the normalized Euclidean distance from 1 to obtain the similarity coefficient.

[0016] Compared with the prior art, the present invention offers the following advantages: by providing a soft tip and a hydrophilic coating at the end of the guidewire body, and by designing the PTFE sheath of the guidewire into a spiral grooved surface, the frictional resistance of the guidewire during delivery within a blood vessel or channel is reduced. A speed sensor collects the guidewire delivery speed in real time, and combined with Savitzky–Golay filtering and sliding window least squares fitting, accurate real-time speed data is obtained, allowing dynamic judgment on whether resistance adjustment is necessary. A 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 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 appropriate rotation angle from the clustering results to achieve precise control of the torque motor. Based on the similarity-corrected initial rotation angle value, 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 avoiding lumen rupture caused by excessive guidewire entry speed. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Various other advantages and benefits will become apparent to those skilled in the art upon reading the detailed description of the preferred embodiment below. The accompanying drawings are for illustration purposes only and are not to be considered as limiting the present invention. The same reference symbols are used throughout the drawings to represent the same components. In the drawings: Figure 1 A schematic structural diagram of a spiral guidewire device provided in an embodiment of the present invention; Figure 2Schematic diagram of the cooperation between the barrel and the extrusion ring of the spiral guide wire device provided in the embodiment of the present invention Figure 1 ; Figure 3 Schematic diagram of the cooperation between the barrel and the extrusion ring of the spiral guide wire device provided in the embodiment of the present invention Figure 2 ; Figure 4 This is a flow chart of a method for adjusting resistance of a spiral guidewire device provided in an embodiment of the present invention.

[0018] Wherein: 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. Bracket; 26. Transmission chain; 3. Control device. DETAILED DESCRIPTION

[0019] Exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. Although exemplary embodiments of the present disclosure are shown in the accompanying drawings, it should be understood that the present disclosure can be implemented in various forms and should not be limited by the embodiments set forth herein. On the contrary, these embodiments are provided to enable a more thorough understanding of the present disclosure and to fully convey the scope of the present disclosure to those skilled in the art. It should be noted that, unless there is a conflict, the embodiments of the present disclosure and the features in the embodiments can be combined with each other. The present invention will be described in detail below with reference to the accompanying drawings and in conjunction with the embodiments.

[0020] In some embodiments of this application, see Figures 1-3 As shown, a spiral guidewire device is proposed, comprising: a guidewire body 1, an extrusion device 2, a control device 3 and a base 4; The guidewire body 1 includes a core 12 and a spiral outer skin 13. The core 12 is made of metal material, the spiral outer skin 13 is a PTFE coating layer, and the surface of the spiral outer skin 13 has a spiral groove 11. The end of the guidewire body 1 is a soft tip end, and the surface of the soft tip end is provided with a hydrophilic coating; The extrusion device 2 is used to extrude the guide wire body 1, and includes a barrel 21, an extrusion ring 22, a speed sensor 23 and a torque motor 24. The barrel 21 is fixed to the base 4 through a bracket 25, and the extrusion ring 22 is sleeved on the outside of the barrel 21 and is rotatably connected relative to the axis of the barrel 21. The torque motor 24 drives the extrusion ring to rotate through a transmission chain 26. A squeezing ball 221 is provided inside the squeezing ring 22, and the barrel 21 is provided with an extrusion block 211 that cooperates with the squeezing ball 221. The barrel 21 is also provided with an elastic component 212 with compressive force, and the two ends of the elastic component 212 are respectively connected to the barrel 21 and the extrusion block 211; the speed sensor 23 is provided at the outlet of the barrel 21, and is used to collect the speed value of the guide wire body 1 during delivery; The control device 3 is electrically connected with the speed sensor 23 and the torque motor 24; the control device 3 dynamically adjusts the resistance of the guide wire body 1 by collecting the speed value of the speed sensor 23 and dynamically controlling the forward and reverse rotation of the torque motor 24 based on the speed value.

[0021] A shell is further arranged for integrally covering and protecting the guide wire body 1, the extrusion device 2, the control device 3 and the base 4. The shell is made of light metal material or high-strength engineering plastic, and the outer surface of the shell is provided with anti-skid lines so as to be stably held by an operator during guide wire delivery. An installation cavity is formed in the shell, and a plurality of fixing seats are arranged in the installation cavity for fixing the base. Holes are further arranged on the two side surfaces of the shell for the guide wire body to extend in and out.

[0022] Specifically, the guidewire body 1 comprises a core 12 and a spiral sheath 13. The core 12 is made of a high-strength metal material to ensure rigidity and bending resistance during delivery. The spiral sheath 13 is coated with polytetrafluoroethylene (PTFE) and has a low coefficient of friction, thereby reducing frictional resistance between the guidewire and the vessel wall or lumen during delivery. The spiral sheath 13 is formed with a continuous spiral groove 11 on its surface, which enhances the flexibility and controllability of the guidewire body during delivery. The guidewire body 1 has a soft tip made of a flexible material and coated with a hydrophilic coating to reduce friction when encountering liquid environments, thereby improving the smoothness and safety of the guidewire as it enters the vessel or channel. The extrusion device 2 is used to compress the guidewire body 1 and adjust its resistance. It comprises a barrel 21, an extrusion ring 22, a speed sensor 23, and a torque motor 24. The barrel 21 is fixed to the base 4 via a bracket 25 to ensure the stability of the overall structure. The extrusion ring 22 is sleeved on the outside of the cylinder 21 and is connected to the axis of the cylinder 21 for relative rotation. The torque motor 24 is connected to the extrusion ring 22 through a transmission chain 26, thereby driving the extrusion ring 22 to rotate. A squeezing ball 221 is provided inside the squeezing ring 22, and a squeezing block 211 that cooperates with the squeezing ball 221 is provided at the corresponding position of the cylinder 21. The cylinder 21 is also provided with an elastic component 212 with a compressive force. The two ends of the elastic component 212 are respectively connected to the cylinder 21 and the squeezing block 211, which is used to provide elastic restoring force during the squeezing process to ensure the stability of the squeezing force. The speed sensor 23 is installed at the outlet of the cylinder 21 and is used to collect the speed value of the guide wire body 1 during delivery in real time. 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 controls the torque motor 24 to rotate forward or reverse based on the speed value, thereby dynamically adjusting the resistance of the squeezing device 2 to the guide wire body 1 and realizing intelligent regulation of the resistance. The device is also provided with a shell for overall covering and protection of the guidewire body 1, the extrusion device 2, the control device 3 and the base 4. The shell is made of lightweight metal material or high-strength engineering plastic, which not only ensures the structural strength of the device, but also reduces the overall weight, making it easier for the operator to hold it in hand. The outer surface of the shell is provided with ergonomic anti-slip grooves, which can provide the operator with a stable grip during the guidewire delivery process and avoid slipping during operation. An installation cavity is formed inside the shell, and a number of fixing seats are provided in the installation cavity for fixing the base 4 and the extrusion device 2 to ensure that the internal components will not be displaced due to vibration or external force during use. Guidewire holes are symmetrically provided on both sides of the shell, and the guidewire body 1 can be inserted into or extended through the hole. A rounded transition structure is provided at the edge of the hole to prevent the guidewire from being scratched when entering and exiting.

[0023] During operation, the operator first confirms that the guidewire body 1 is in a clean and uncontaminated state; checks whether the soft tip of the guidewire body 1 is intact and the hydrophilic coating is intact; extends the free end of the guidewire body 1 through the hole on the side of the shell, passes through the barrel 21 and cooperates with the extrusion device 2. Connect the control device 3 to the power supply, check whether the signal interface and the speed sensor 23 are normal; after the control device 3 is initialized, it drives the torque motor 24, which in turn drives the extrusion ring 22 and the extrusion ball 221 to rotate the extrusion block 211 and form an initial contact pressure between the extrusion block 211 and the guidewire body 1. The operator uses the outer shell gripping device to gradually deliver the guidewire body 1 into the target lumen or blood vessel; during the delivery process, the guidewire body 1 maintains contact with the inner wall of the barrel 21 and the extrusion block 211, and the extrusion device 2 applies a 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 guidewire delivery is too fast, too slow, or stuck. When the guidewire speed exceeds a preset range, the control device 3 adjusts the rotation direction and speed of the torque motor 24 to drive the extrusion ring 22 to rotate. The extrusion ring 22 drives the extrusion ball 221 to cooperate with the extrusion block 211, squeezing and changing the friction force on the guidewire body 1, achieving dynamic adjustment of the resistance, thereby ensuring a smooth and safe guidewire delivery speed. When the guidewire reaches the predetermined position, the operator can stop delivery. The control device 3 keeps the motor stable, and the extrusion device 2 continues to provide appropriate resistance to fix the guidewire to prevent it from retreating or shifting.

[0024] It is understandable that since the guidewire body adopts a composite structure of a metal wire core and a PTFE spiral outer skin, and the outer skin surface is provided with spiral grooves, it can effectively reduce the friction resistance of the guidewire in the vascular cavity, improve the flexibility and passability of the guidewire, and at the same time, cooperate with the hydrophilic coating of the soft tip to make the guidewire delivery in complex vascular pathways smoother, reducing the risk of vascular damage. By providing an extrusion device, a speed sensor and a control device, it is possible to collect speed parameters in real time during the guidewire delivery process, and dynamically adjust the forward and reverse rotation of the torque motor, thereby adjusting the friction force of the extrusion ring on the guidewire, realizing dynamic adjustment of the guidewire resistance, and avoiding the problem of guidewire slippage or jamming caused by excessive or insufficient resistance.

[0025] In another preferred embodiment based on the above embodiment, refer to Figure 4 As shown, this embodiment provides a method for adjusting the resistance of a spiral guidewire device, which is used to apply the above-mentioned spiral guidewire device, including: The speed value of the speed sensor is collected in real time based on the Savitzky–Golay filtering method, and the speed value is compared with the speed threshold to determine whether the resistance value of the guidewire body needs to be adjusted; 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; and the torque motor is adjusted based on the torque motor rotation angle value; The resistance of the guidewire body is dynamically adjusted by adjusting the rotation direction and rotation angle of the torque motor.

[0026] Specifically, a velocity sensor continuously collects instantaneous velocity data of the guidewire during delivery at a fixed sampling frequency and stores the collected data in a circular buffer in real time to ensure data continuity and real-time performance. Subsequently, a control device smoothes the data from each new sampling point and several preceding and succeeding sampling points 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 of the window is calculated as the actual guidewire velocity at the current moment. This effectively reduces noise interference and preserves the true motion characteristics of the guidewire. The filtered velocity value is then compared with a preset velocity threshold. Based on the velocity determination results, the control device determines a rotation strategy for the torque motor, including a forward rotation strategy to increase resistance and a reverse rotation strategy to reduce resistance. It also generates candidate rotation angles and corresponding feature data, including guidewire motion characteristics and torque motor characteristics. The candidate angles and historical data sets are then integrated to form a clustered data set. This data set is then normalized and clustered using the DBSCAN clustering algorithm to identify core points, boundary points, and noise points in the data set, thereby 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 compression force of the guidewire body through the extrusion ring and extrusion ball to achieve dynamic adjustment of the guidewire resistance; during the whole process, the guidewire 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 guidewire entry speed and achieve closed-loop control.

[0027] As can be understood, the real-time monitoring of guidewire speed by a speed sensor and the smoothing of data using the Savitzky–Golay filter method effectively eliminate noise interference and obtain accurate guidewire speed information. The control device determines whether resistance adjustment is necessary based on the speed threshold, ensuring smooth advancement of the guidewire within the vessel or channel and reducing the risk of guidewire jamming or slippage. The torque motor's forward and reverse rotation and angle adjustment enable real-time dynamic control of the guidewire resistance. DBSCAN cluster analysis of historical rotation data and current feature data automatically selects the optimal rotation angle, avoiding misadjustments caused by single abnormal data and improving the stability and reliability of resistance adjustment.

[0028] In some embodiments of the present application, when real-time acquisition of the speed value of the speed sensor is performed based on the Savitzky–Golay filtering method, the method includes: The speed sensor continuously outputs a speed data stream at a fixed sampling frequency and stores the speed data stream in a ring buffer in real time. A sliding window of each new sampling point and several adjacent sampling points is automatically intercepted. Within the sliding window, a low-order polynomial is fitted based on the least squares method, and the function value of the low-order polynomial at the center point of the window is used as the speed value at the current moment.

[0029] Specifically, the velocity sensor continuously collects instantaneous velocity data of the guidewire at a fixed sampling frequency and stores this data in real time in a circular buffer, ensuring that the latest data overwrites the oldest data, enabling continuous updating and real-time storage. Subsequently, for each new sampling point, several adjacent sampling points before and after it are automatically intercepted to form a sliding window. For example, the window length can be set to 5 to 11 sampling points. This ensures that the current velocity calculation not only references the current sampling point but also takes into account surrounding historical and adjacent data, smoothing out 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 ​​for all sample points within the window is minimized, thereby obtaining the best-fit curve. After fitting, the polynomial function value at the center of the sliding window is used as the guidewire velocity value at the current moment. This velocity value not only eliminates the interference of sensor noise on the data but also truly reflects the motion state of the guidewire at that moment. This filtered velocity value is then transmitted to the control device, which determines whether the guidewire resistance needs to be adjusted and further determines the rotation direction and angle of the torque motor, achieving closed-loop dynamic control. As new velocity sampling points arrive, the sliding window continues to advance, repeating the above process. This enables continuous, real-time filtering and output of velocity data, providing reliable and accurate input data for guidewire resistance adjustment.

[0030] For example, during guidewire delivery, the velocity sensor continuously collects instantaneous velocity data of the guidewire body at a fixed sampling frequency and stores the collected data in real time in a circular buffer. For each new sampling point, several adjacent sampling points before and after it are intercepted to form a sliding window. A second- or third-order polynomial is fitted within the window using the least squares method, and the function value of the polynomial at the center point is calculated as the filtered velocity value at the current moment. If the continuously collected velocity data is 4.0, 4.2, 3.8, 4.5, and 4.1 mm / s, the center point velocity after fitting within the window is 4.08 mm / s.

[0031] As can be understood, the sliding window and low-order polynomial fitting effectively filter out sensor noise and transient fluctuations, making the guidewire velocity measurement smoother and more stable, truly reflecting the guidewire's motion state. Continuously acquiring velocity data at a fixed sampling frequency and updating the circular buffer in real time enables continuous monitoring of guidewire velocity, ensuring that the control device has instant access to the latest velocity information. The filtered velocity value serves as input for resistance determination and torque motor adjustment, ensuring that resistance adjustment is based on accurate velocity information and avoiding misadjustments caused by noise or transient abnormal data.

[0032] In some embodiments of the present application, when fitting a low-order polynomial value based on the least squares method, the method includes: All data points within the sliding window are collected, and several adjacent data points are selected as sample points. The corresponding polynomial function is constructed according to the set order of the fitting polynomial. Based on the sample points, the least squares method is used to calculate the coefficients of the polynomial function to minimize the sum of squares of the errors between the actual values ​​of the sample points and the fitted values. The data points within the window interval are fitted according to the polynomial function to obtain low-order polynomial values.

[0033] Specifically, all velocity data points within a 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 adjacent data, thereby avoiding the influence of single-point noise on the results. Subsequently, a corresponding polynomial function is constructed based on the pre-set polynomial order (usually second or third order). The least squares method is used to calculate the selected sample points, and the best-fit curve is obtained by solving the polynomial coefficients that minimize the sum of squared errors between the actual sample point values ​​and the fitted polynomial values. After the fitting is complete, the polynomial function is applied to all data points within the sliding window, and the velocity of each point is predicted and calculated to obtain a smoothed low-order polynomial value. This smoothed velocity value not only eliminates sensor noise interference but also truly reflects the current motion state of the guidewire, providing a reliable basis for subsequent resistance determination and torque motor adjustment.

[0034] As can be understood, the combination of the sliding window and least squares method enables continuous fitting and real-time updating of velocity data, providing reliable velocity input to the control device and ensuring timely response to dynamic resistance adjustment. The filtered low-order polynomial value can be used as a reference to determine whether the guidewire resistance is excessive or insufficient, improving the accuracy of torque motor adjustment and avoiding erroneous operation caused by noise or abnormal data.

[0035] In some embodiments of the present application, 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 less 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 there is no need to adjust the resistance value of the guidewire body; 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.

[0036] Specifically, after obtaining the filtered guidewire speed value, the speed value is compared with a preset speed threshold to determine whether it is necessary to adjust the resistance of the guidewire body. Specifically, the speed threshold includes a first speed threshold and a second speed threshold, wherein the first speed threshold is less than the second speed threshold. For example, assume that the first speed threshold is 4.5 mm / s and the second speed threshold is 6.0 mm / s. If the current filtered speed value is less than or equal to the first speed threshold, such as 4.0 mm / s, it is determined that the guidewire resistance is too large and the resistance needs to be reduced; if the current speed value is between the first speed threshold and the second speed threshold, such as 5.2 mm / s, it is determined that the guidewire resistance is in a normal range and no adjustment is required; if the current speed value is greater than or equal to the second speed threshold, such as 6.2 mm / s, it is determined that the guidewire resistance is too small and the resistance needs to be increased.

[0037] It is understandable that by setting the first and second speed thresholds, it is possible to clearly determine whether the guidewire resistance is too large, too small, or normal, thereby making targeted adjustments to the torque motor and improving the accuracy of resistance control. The ability to dynamically judge the resistance state based on the real-time speed avoids the guidewire from getting stuck due to excessive resistance or getting out of control due to too little resistance during delivery, thereby achieving smooth advancement. Accurate resistance control reduces the friction and risk of damage to the guidewire in complex channels or blood vessels, thereby improving operational safety. Through dual-threshold judgment, the control device only adjusts the torque motor when necessary, avoiding frequent and ineffective operations and improving the response efficiency and reliability of the entire guidewire delivery.

[0038] In some embodiments of the present application, when it is determined that the resistance value needs to be adjusted, determining the torque motor rotation plan includes: The torque motor rotation scheme includes a torque motor forward rotation scheme and a torque motor reverse rotation scheme; When the resistance value of the guidewire body needs to be reduced, the torque motor reversal solution is determined; When the resistance value of the guidewire body needs to be increased, the torque motor forward rotation solution is determined to be adopted.

[0039] Specifically, if the speed value is lower than the first speed threshold, it is determined that the guidewire resistance is too large and the resistance needs to be reduced. At this time, the control device selects the reverse rotation scheme of the torque motor to rotate the extrusion ring in the opposite direction of the guidewire movement. Through the slight reverse rotation of the extrusion ring and the extrusion ball, the pressure between the guidewire and the extrusion block is reduced, thereby reducing the friction resistance of the guidewire in the barrel, and the guidewire delivery speed is restored to a reasonable range. If the speed value is higher than the second speed threshold, it is determined that the guidewire resistance is too small and the resistance needs to be increased. At this time, the control device selects the forward rotation scheme of the torque motor to rotate the extrusion ring in the direction of the guidewire movement. Forward rotation increases the pressure of the extrusion ring on the guidewire, thereby increasing the friction resistance of the guidewire in the barrel, and reducing the guidewire delivery speed to a reasonable range.

[0040] As you can understand, directly adjusting the pressure of the extrusion ring on the guidewire through forward or reverse rotation instantly changes the guidewire resistance, enabling rapid response to speed changes. Selecting the appropriate rotation scheme based on the speed threshold ensures the correct direction of resistance adjustment, effectively avoiding abnormal guidewire speed caused by over-adjustment or incorrect direction.

[0041] In some embodiments of the present application, when selecting a torque motor rotation angle value from a determined torque motor rotation scheme based on DBSCAN clustering, the method includes: Obtain all rotation angle values ​​and corresponding feature data in the torque motor rotation scheme and construct a historical data set; the feature data includes torque motor feature data and guidewire 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 set to be clustered; The cluster set is clustered according to DBSCAN clustering, and the rotation angle value is determined according to the clustering result.

[0042] Specifically, when the guidewire resistance needs to be adjusted and the torque motor rotation scheme has been determined, the torque motor rotation angle is intelligently selected using the DBSCAN clustering method. Specifically, the historical operation data is first acquired, including the rotation angle corresponding to each rotation scheme and related feature data, such as the torque motor speed, power, and real-time guidewire speed and resistance values, and these data are constructed into a historical data set. Subsequently, the historical data set is integrated with the current real-time feature data to form a set to be clustered, and all feature data are standardized to eliminate dimensional differences. Next, the DBSCAN algorithm is used to perform cluster analysis on the set to be clustered to identify core clusters similar to the current operating state.

[0043] As can be understood, combining historical empirical data with real-time feature information intelligently selects the optimal rotation angle, enabling more precise guidewire resistance adjustment and avoiding speed fluctuations or excessive friction caused by fixed-angle adjustment. DBSCAN clustering can identify similarities between the current guidewire state and historical data, enabling adaptive adjustment for different operating environments and guidewire states. Automatically determining the rotation angle using historical data and real-time analysis reduces the frequency and complexity of manual adjustments by the operator, thereby mitigating operational risks.

[0044] In some embodiments of the present application, clustering the set of clusters to be clustered is performed according to DBSCAN clustering, and determining the rotation angle value according to the clustering result includes: S1: For each data point, determine the set of neighboring points within its ε neighborhood; S2: If the number of neighbor points is greater than or equal to the preset minimum number of neighbors minPts, the data point is marked as a core point, and the points in its neighborhood are added to the same cluster; S3: Repeat S1 and S2 for the new core points in the cluster until the cluster expansion is completed; S4: When the cluster where the data set is located 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 where the data set is located contains a historical data set, the average value of the historical rotation angle values ​​corresponding to all the historical data sets contained is selected as the rotation angle value.

[0045] Specifically, when the guidewire resistance needs to be adjusted, characteristic data such as the current guidewire speed and force are first collected and integrated with historical operation data to form a clustered set. This set is then clustered using the DBSCAN algorithm: for each data point, the number of neighboring points within its neighborhood of radius ε is determined. Data points whose number of neighbors reaches a preset minimum value, minPts, are marked as core points, and points within their neighborhood are added to the same cluster. This process is repeated for new core points within the cluster until the cluster is expanded. After clustering is complete, if the cluster containing the current data contains a historical data set, the average of all historical rotation angles within the cluster is taken as the current torque motor rotation angle. If the cluster does not contain a historical data set, the rotation angle with the highest similarity to the historical data is selected as the initial value, and fine-tuning is performed based on this similarity.

[0046] It is understood that combining historical data with real-time features enables precise control of guidewire resistance, avoiding excessive friction or speed fluctuations caused by fixed or empirical value adjustments. It can identify the similarity between the current operating state and historical experience and automatically select the optimal rotation angle to adapt to different guidewire states and operating environments.

[0047] In some embodiments of the present application, 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 includes: The similarity coefficient of the maximum similarity between the data set and the historical data set is calculated based on the Euclidean distance algorithm, and the similarity coefficient is used as the correction coefficient. The initial rotation angle value is corrected based on the correction coefficient, and the corrected initial rotation angle value is used as the rotation angle value.

[0048] In some embodiments of the present application, when calculating the similarity coefficient of the maximum similarity between a data set and a historical data set based on the Euclidean distance algorithm, the method includes: Determine the feature data with the maximum similarity between the data set and the historical data set, and standardize the feature data; calculate the difference for each pair of corresponding data in the feature data, square the difference, accumulate the square differences of all data to obtain the overall difference value, and perform square root operation on the overall difference value to obtain the Euclidean distance of the maximum similarity between the data set and the historical data set in the multidimensional feature space, normalize the Euclidean distance according to the maximum and minimum values ​​of all data distances, and then subtract the normalized Euclidean distance from 1 to obtain the similarity coefficient.

[0049] Specifically, all feature data (including torque motor features and guidewire motion features) in the current and historical datasets are standardized to make data of different dimensions comparable and eliminate the impact of dimensional differences on distance calculation. The dimension-by-dimensional difference between the corresponding features of each historical sample in the current and historical datasets is calculated. The differences are squared, summed, and then squared to obtain the Euclidean distance in the multidimensional feature space. Among all historical samples, the sample with the smallest Euclidean distance is selected, indicating the data point with the greatest similarity to the current dataset. The minimum Euclidean distance is normalized (e.g., normalized 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 factor to fine-tune the initial rotation angle to better match the current data characteristics. This corrected angle serves as the final rotation angle value, which is used to perform the torque motor rotation operation.

[0050] As can be understood, calculating the Euclidean distance between the current and historical data sets in a multidimensional feature space accurately assesses similarity, allowing the torque motor's initial rotation angle to more closely align with actual requirements. Using the similarity coefficient to correct the initial angle, the rotation angle can be automatically fine-tuned based on the current guidewire state, achieving intelligent adjustment without manual intervention. By combining historical data with real-time collected features and leveraging existing experience, the reliability of torque motor control is improved while adapting to real-time changes in guidewire state.

[0051] 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 extrusion ring speed), forming a historical data set. The feature data collected for the current guidewire motion state are: instantaneous guidewire speed: 0.85 m / s, guidewire force: 1.2 N, and extrusion ring speed: 150 rpm. The historical data set (e.g., the past 100 sets of data) and the current feature data are combined into a clustering set. Each feature data set is normalized to make data of different dimensions comparable. Parameters are set: ε = 0.2 (neighborhood radius) and minPts = 5 (minimum number of neighbors). Clustering the clustering set reveals that the current data set falls into a new cluster containing three 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°. Calculate the similarity coefficient based on the Euclidean distance: Assuming the normalized Euclidean distance is 0.2, the similarity coefficient = 1 - 0.2 = 0.8. Multiply the initial rotation angle of 30° by the correction factor of 0.8 to obtain the corrected rotation angle = 30° × 0.8 = 24°. Based on the corrected angle of 24°, the torque motor is controlled to rotate forward or reverse, completing the dynamic adjustment of the guidewire resistance.

[0052] In summary, by designing a soft tip and a hydrophilic coating on the end of the guidewire body and designing the PTFE sheath with a spiral groove pattern, the frictional resistance of the guidewire during delivery within a blood vessel or channel is reduced. A speed sensor acquires the guidewire delivery speed in real time. Combined with Savitzky–Golay filtering and sliding window least squares fitting, accurate real-time speed data is obtained, allowing dynamic judgment on whether resistance adjustment is necessary. A 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 the guidewire resistance and ensuring continuity and stability during guidewire delivery. The DBSCAN clustering method is used to analyze historical torque motor rotation data and guidewire motion feature data. The optimal rotation angle is selected from the clustered results, enabling precise control of the torque motor. Based on the similarity-corrected initial rotation angle value, the resistance adjustment accuracy is further optimized, ensuring that the guidewire delivery resistance better meets actual operating conditions. This ensures the stability of the guidewire entry speed and prevents lumen rupture caused by excessive guidewire entry.

[0053] Those skilled in the art will appreciate that the embodiments of the present application may be provided as methods, systems, or computer program products. Therefore, the present application may take the form of an entirely hardware embodiment, an entirely software embodiment, or an embodiment combining software and hardware. Furthermore, the present application may take the form of a computer program product implemented on one or more computer-usable storage media (including but not limited to magnetic disk storage, CD-ROM, optical storage, etc.) containing computer-usable program code.

[0054] The present application is described with reference to the flowcharts and / or block diagrams of the methods, devices (systems) and computer program products according to the embodiments of the present application. It should be understood that each process and / or box in the flowchart and / or block diagram, as well as the combination of processes and / or boxes in the flowchart and / or block diagram, can be implemented by computer program instructions. These computer program instructions can be provided to a processor of a general-purpose computer, a special-purpose computer, an embedded processor or other programmable data processing device to produce a machine, so that the instructions executed by the processor of the computer or other programmable data processing device generate instructions for implementing the processes in the flowchart and / or block diagram. Figure 1 a process or multiple processes and / or boxes Figure 1 A device that provides the functions specified in a block or multiple blocks.

[0055] These computer program instructions may also be stored in a computer readable memory that can direct a computer or other programmable data processing device to work in a specific manner, so that the instructions stored in the computer readable memory produce an article of manufacture comprising an instruction device, which implements the process Figure 1 a process or multiple processes and / or boxes Figure 1 The function specified in one or more boxes.

[0056] These computer program instructions can also be loaded onto a computer or other programmable data processing device so that a series of operational steps are executed on the computer or other programmable device to produce a computer-implemented process, thereby providing the instructions executed on the computer or other programmable device for implementing the process. Figure 1 a process or multiple processes and / or boxes Figure 1 A step that specifies a function in one or more boxes.

[0057] 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, ordinary technicians in the field should understand that the specific implementation methods of the present invention can still be modified or replaced by equivalents. Any modification or equivalent replacement that does not depart from the spirit and scope of the present invention should be covered by the scope of protection of the claims of the present invention.

Claims

1. A spiral guide wire device, characterized in that: include: Guidewire body, extrusion device, control device and base; The guide wire body comprises a wire core and a spiral outer skin, wherein the wire core is made of metal material, the spiral outer skin is a PTFE coating layer, the surface of the spiral outer skin has spiral grooves, and the end of the guide wire body is a soft tip end, and the surface of the soft tip end is provided with a hydrophilic coating; The extrusion device is used to extrude the guide wire body, and includes a barrel, an extrusion ring, a speed sensor and a torque motor. The barrel is fixed to the base through a bracket, the extrusion ring is sleeved on the outside of the barrel and is rotatably connected relative to the axis of the barrel, the torque motor drives the extrusion ring to rotate through a transmission chain, a squeezing ball is provided inside the squeezing ring, the barrel is provided with an extrusion block that cooperates with the squeezing ball, and the barrel is further provided with an elastic component with compressive force, and the two ends of the elastic component are respectively connected to the barrel and the extrusion block; the speed sensor is provided at the outlet of the barrel, and is used to collect the speed value of the guide wire body during delivery; 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 guidewire body.

2. A method for adjusting resistance of a spiral guide wire device, applied to a spiral guide wire device as claimed in claim 1, characterized in that: include: The speed value of the speed sensor is collected in real time based on the Savitzky–Golay filtering method, and the speed value is compared with the speed threshold to determine whether the resistance value of the guidewire body needs to be adjusted; When it is determined that the resistance value needs to be adjusted, determining a torque motor rotation scheme, and selecting a torque motor rotation angle value from the determined torque motor rotation scheme based on DBSCAN clustering; adjusting the torque motor based on the torque motor rotation angle value; The resistance of the guidewire body is dynamically adjusted by adjusting the rotation direction and rotation angle of the torque motor.

3. The method for adjusting the resistance of a spiral guide wire device according to claim 2, wherein: When real-time acquisition of the speed value of the speed sensor is based on the Savitzky–Golay filtering method, it includes: The speed sensor continuously outputs a speed data stream at a fixed sampling frequency and stores the speed data stream in a ring buffer in real time; automatically intercepts a sliding window of each new sampling point and several adjacent sampling points before and after it; and fits a low-order polynomial within the sliding window based on the least squares method, using the function value of the low-order polynomial at the center point of the window as the speed value at the current moment.

4. A method for adjusting resistance of a spiral guide wire device according to claim 3, characterized in that: When fitting low-order polynomial values ​​based on the least squares method, including: All data points within the sliding window are collected, and several adjacent data points are selected as sample points; a corresponding polynomial function is constructed according to the set order of the fitting polynomial; based on the sample points, the least squares method is used to calculate the coefficients of the polynomial function to be calculated, and the sum of squares of errors between the actual values ​​of the sample points and the fitted values ​​is minimized; the data points within the window interval are fitted according to the polynomial function to obtain low-order polynomial values.

5. The method for adjusting the resistance of a spiral guide wire device according to claim 4, characterized in that: Comparing the speed value with the speed threshold to determine whether the resistance value of the guidewire body needs to be adjusted includes: The speed threshold includes a first speed threshold and a second speed threshold; the first speed threshold is less than the second speed threshold; When the speed value is less than or equal to the first speed threshold, determining 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 there is no need to adjust the resistance value of the guidewire body; 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.

6. The method for adjusting the resistance of a spiral guide wire device according to claim 5, characterized in that: When it is determined that the resistance value needs to be adjusted, determining the torque motor rotation plan includes: The torque motor rotation scheme includes a torque motor forward rotation scheme and a torque motor reverse rotation scheme; When the resistance value of the guidewire body needs to be reduced, determining to adopt the torque motor reversal solution; When the resistance value of the guidewire body needs to be increased, the torque motor forward rotation solution is determined to be adopted.

7. A method for adjusting resistance of a spiral guide wire device according to claim 6, characterized in that: When selecting the torque motor rotation angle value according to the torque motor rotation scheme determined based on DBSCAN clustering, the method includes: Obtain all rotation angle values ​​and corresponding feature data in the torque motor rotation scheme and construct a historical data set; the feature data includes torque motor feature data and guidewire motion feature data; perform standardization on 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 set to be clustered; The cluster set is clustered according to DBSCAN clustering, and the rotation angle value is determined according to the clustering result.

8. The method for adjusting the resistance of a spiral guide wire device according to claim 7, characterized in that: Clustering the cluster set according to DBSCAN clustering and determining the rotation angle value according to the clustering results include: S1: For each data point, determine the set of neighboring points within its ε neighborhood; S2: If the number of neighbor points is greater than or equal to the preset minimum number of neighbors minPts, the data point is marked as a core point, and the points in its neighborhood are added to the same cluster; S3: Repeat S1 and S2 for the new core points in the cluster until the cluster expansion is completed; S4: When the cluster where the data set is located 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 where the data set is located 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.

9. The method for adjusting the resistance of a spiral guide wire device according to claim 8, characterized in that: 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, it includes: The similarity coefficient of the maximum similarity between the data set and the historical data set is calculated based on the Euclidean distance algorithm, and the similarity coefficient is used as a correction coefficient. The initial rotation angle value is corrected based on the correction coefficient, and the corrected initial rotation angle value is used as the rotation angle value.

10. The method for adjusting the resistance of a spiral guide wire device according to claim 9, characterized in that: When calculating the similarity coefficient of the maximum similarity between the data set and the historical data set based on the Euclidean distance algorithm, the method includes: Determine the feature data with the maximum similarity between the data set and the historical data set, and standardize the feature data; calculate the difference for each pair of corresponding data in the feature data, square the difference, accumulate the square differences of all data to obtain an overall difference value, and perform a square root operation on the overall difference value to obtain the Euclidean distance of the maximum similarity between the data set and the historical data set in the multidimensional feature space, normalize the Euclidean distance according to the maximum and minimum values ​​of all data distances, and then subtract the normalized Euclidean distance from 1 to obtain the similarity coefficient.

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