In vivo orientation method and system for vascular stents based on the principle of spatial inversion

Abstract

This application provides a method and system for in vivo stent orientation based on the principle of spatial reversal, relating to the field of vascular interventional technology. The method includes: during the advancement of a main stent delivery system carrying an integrated branch stent along an ultra-rigid guidewire towards the aortic arch, acquiring the orientation information of the delivery system and its contact force information with the vessel wall; then comparing the orientation information with a spatial reference path, and determining the entry point into the curved section of the aortic arch based on the comparison results; generating a reversal speed adjustment amount based on the deviation of the delivery system's orientation from the branch vessel opening direction, the vessel curvature, and the contact force information; finally, controlling the delivery system to rotate synchronously during advancement based on this adjustment amount, gradually adjusting the orientation of the branch stent from a preset position to directly facing the opening of the left subclavian artery, while dynamically adjusting the advancement speed according to the contact force information to maintain the contact force within a preset safe range. This application improves the accuracy and operational safety of in vivo stent orientation.

Description

Technical Field

[0001] This application relates to the field of vascular interventional technology, and in particular to a method and system for in vivo orientation of vascular stents based on the principle of spatial reversal. Background Technology

[0002] Endovascular repair of aortic arch vascular diseases is an important treatment method in vascular surgery, among which in vivo stent placement technology involving branch vessel reconstruction has broad application prospects. This technique precisely delivers the main stent with pre-loaded branch stents to the aortic arch, ensuring accurate alignment of the branch stents with the opening of the left subclavian artery, thus achieving lesion isolation and preservation of branch blood flow.

[0003] In current clinical practice, based on preoperative imaging assessment, the operator loads the branch stent externally into a predetermined orientation. The delivery system is then advanced along a guidewire to the aortic arch, utilizing the natural anatomical shape of the aortic arch to induce spatial reversal of the stent within the body. During this process, the operator must rely on experience to determine the advancement speed and rotation angle of the delivery system, and observe the real-time position of the branch stent through intraoperative angiography, manually adjusting the operating parameters until the branch stent aligns with the opening of the target vessel.

[0004] However, the anatomical structure of the aortic arch exhibits significant individual differences, and the curvature variations in its tortuous segments and the uncertainty of the vessel's course make it difficult to accurately predict the posture changes of the delivery system. Operators relying solely on two-dimensional angiographic images and tactile feedback struggle to obtain real-time precise positioning of the delivery system and its contact with the vessel wall. This results in significant operational dependence on branch stent orientation adjustments, and alignment accuracy is easily affected by subjective factors. Therefore, existing technologies face the technical challenge of simultaneously achieving operational controllability and alignment accuracy during the in-vivo stent orientation process. Summary of the Invention

[0005] This application provides a method and system for in vivo orientation of vascular stents based on the principle of spatial reversal, in order to solve the problems of low accuracy and poor operational safety of in vivo stent orientation in the prior art.

[0006] To address the aforementioned technical problems, in a first aspect, this application provides a method for in vivo orientation of vascular stents based on the principle of spatial reversal, comprising: During the process of pushing the delivery system loaded with the main stent along the ultra-rigid guidewire pre-placed in the aorta towards the aortic arch, the positional information of the delivery system and the contact force information between the delivery system and the blood vessel wall are collected. The main stent integrates a branch stent, which is oriented toward the preset position of the femoral artery when loaded externally. The pose information is compared with a pre-established spatial reference path to obtain a comparison result. The spatial reference path includes the vascular centerline information. When the delivery system is determined to have entered the curved section of the aortic arch based on the comparison results, a continuous reverse speed adjustment is generated and executed based on the deviation between the orientation of the delivery system and the direction of the branch vessel opening, the vessel curvature, and the contact force information. Based on the continuous reversal speed adjustment, the delivery system is controlled to rotate synchronously during forward movement, so that the orientation of the branch support is gradually adjusted from the preset orientation to face the opening of the left subclavian artery when passing through the curved section. At the same time, the forward speed is dynamically adjusted according to the contact force information to keep the contact force within a preset safe range.

[0007] Optionally, the reversal speed adjustment includes a reversal angle and a reversal speed curve; Based on the deviation between the orientation of the delivery system and the direction of the branch vessel opening, the vessel curvature, and the contact force information, a continuous reversal speed adjustment is generated and executed, including: Preoperative images of computed tomography angiography were acquired, and a three-dimensional model of the aortic arch was obtained by three-dimensional reconstruction of the preoperative images. The branch vessel opening locations and vessel curvature are extracted from the three-dimensional model of the aortic arch, and the branch vessel opening directions are determined based on the branch vessel opening locations and vessel centerlines. The orientation information in the pose information is compared with the direction of the branch vessel opening to calculate the deviation between the orientation of the delivery system and the direction of the branch vessel opening. Based on the deviation, the vessel curvature, and the contact force information, and combined with the degree of deviation between the stent imaging point position extracted from the preoperative image and the spatial reference path, an initial reversal angle and an initial reversal speed curve are generated. The pose information, contact force information, vascular curvature, initial reversal angle, and initial reversal speed curve are input into a pre-constructed state discrimination network to obtain guidewire configuration features. The initial reversal angle and the initial reversal speed curve are adjusted according to the guidewire configuration features to obtain the updated reversal angle and the updated reversal speed curve.

[0008] Optionally, the step of inputting the pose information, the contact force information, the vascular curvature, the initial reversal angle, and the initial reversal speed curve into a pre-constructed state discrimination network to obtain guidewire configuration features, and adjusting the initial reversal angle and the initial reversal speed curve according to the guidewire configuration features to obtain updated reversal angle and updated reversal speed curve, includes: The pose information, contact force information, vascular curvature, initial reversal angle, and initial reversal speed curve are input into the state discrimination network as input data. The state discrimination network extracts features from the input data and outputs guidewire configuration features. The guidewire configuration features are used to characterize the spatial morphology of the guidewire in the aorta. The guidewire configuration feature is compared with a preset guidewire configuration reference range to obtain the degree of deviation of the guidewire configuration feature from the guidewire configuration reference range; Based on the degree of deviation, a reversal angle correction amount and a reversal speed curve correction amount are generated; The reversal angle correction is superimposed on the initial reversal angle to obtain the updated reversal angle, and the reversal speed curve correction is superimposed on the initial reversal speed curve to obtain the updated reversal speed curve.

[0009] Optionally, the step of controlling the delivery system to rotate synchronously during forward movement based on the continuous reversal speed adjustment, so that the orientation of the branch support gradually adjusts from the preset orientation to face the opening of the left subclavian artery when passing through the curved section, and simultaneously dynamically adjusts the forward speed according to the contact force information to maintain the contact force within a preset safe range, includes: During the process of the conveying system moving through the curved section along the spatial reference path, the updated reversal angle is used as the initial target rotation angle and the updated reversal speed curve is used as the rotation speed basis to control the conveying system to perform rotational actions. During the rotation process, the location of the visualization point of the branch stent is extracted from the intraoperative images in real time. The location of the visualization point is compared with the location of the opening of the left subclavian artery in the virtual navigation coordinate system to obtain the real-time orientation deviation of the visualization point relative to the opening. The initial target rotation angle is iteratively corrected based on the real-time orientation deviation to obtain the real-time target rotation angle, and the conveying system is controlled to continue performing rotation actions based on the real-time target rotation angle. The forward speed of the conveying system is dynamically adjusted based on the comparison result between the contact force information and the preset safety range. Repeated iterative corrections and forward speed adjustments are made until the position of the imaging point meets the preset alignment condition with the opening of the left subclavian artery, and the orientation of the branch stent is adjusted to be directly opposite the opening of the left subclavian artery.

[0010] Optionally, the pose information of the conveying system is collected, including: The preoperative three-dimensional reconstruction model is spatially registered with the intraoperative images to establish a virtual navigation coordinate system, which includes the spatial reference path of the vessel centerline. The original pose data of the conveying system in the sensor's own coordinate system is collected by a sensor integrated at the far end of the conveying system. The original pose data is converted to the virtual navigation coordinate system to obtain the pose information of the transport system in the virtual navigation coordinate system.

[0011] Optionally, before the delivery system carrying the main stent is advanced along the pre-placed ultra-rigid guidewire into the aortic arch, it further includes: The main stent, which integrates the branch stent, is loaded into the delivery system, and the branch stent is oriented toward a predetermined position of the access femoral artery.

[0012] Optionally, before acquiring the pose information of the conveying system, the method further includes: A dual-lumen guiding catheter is pre-placed in the aorta. A branched guidewire and an ultra-stiff guidewire are threaded through the dual-lumen guiding catheter. The branched guidewire is led out from the left brachial artery, and the distal end of the ultra-stiff guidewire is located in the ascending aorta.

[0013] Optionally, after the orientation of the branch stent is gradually adjusted from the preset orientation to face the opening of the left subclavian artery as it passes through the curved section, the method further includes: The ultra-rigid guidewire is withdrawn from the dual-lumen guiding cannula, and the main stent is continued to be pushed along the spatial reference path. At the same time, the branch guidewire is pulled to guide the branch stent into the opening of the left subclavian artery. Release the main support and the branch support in sequence.

[0014] Secondly, this application provides an in vivo orientation system for vascular stents based on the principle of spatial reversal, comprising: The acquisition module is used to acquire the position and orientation information of the delivery system and the contact force information between the delivery system and the blood vessel wall during the process of pushing the delivery system loaded with the main stent along the ultra-rigid guidewire pre-placed in the aorta to the aortic arch. The main stent integrates a branch stent, which is oriented toward the preset position of the femoral artery when loaded externally. The comparison module is used to compare the pose information with a pre-established spatial reference path to obtain a comparison result. The spatial reference path includes the blood vessel centerline information. The generation module is used to generate and execute a continuous reverse speed adjustment amount based on the deviation between the orientation of the delivery system and the opening direction of the branch vessels, the curvature of the vessels, and the contact force information when it is determined from the comparison results that the delivery system has entered the curved section of the aortic arch. The control module is used to control the delivery system to rotate synchronously during forward movement based on the continuous reversal speed adjustment, so that the orientation of the branch support is gradually adjusted from the preset orientation to face the opening of the left subclavian artery when passing through the curved section. At the same time, the forward speed is dynamically adjusted according to the contact force information to keep the contact force within a preset safety range.

[0015] Thirdly, this application provides a computer-readable storage medium storing a computer program that, when executed by a processor, can implement the steps of the in vivo orientation method for vascular stents based on the spatial inversion principle described in the first aspect above.

[0016] The technical solution provided in this application has the following beneficial effects: This application provides a precise real-time data foundation for subsequent posture adjustments by real-time acquisition of the position and posture information of the delivery system and its contact force with the vessel wall. Then, by comparing the position and posture information with a spatial reference path including the vessel centerline, it can accurately determine whether the delivery system has entered the curved section of the aortic arch, providing a reliable basis for triggering the reversal operation. When entering the curved section, it generates a continuous reversal speed adjustment based on the deviation of the delivery system's orientation from the branch vessel opening direction, the vessel curvature, and the contact force information, thus realizing quantitative control of the reversal action. Finally, based on the reversal speed adjustment, the delivery system rotates synchronously during forward movement, gradually adjusting the orientation of the branch stent from a preset position to face the target blood vessel opening. At the same time, the forward speed is dynamically adjusted according to the contact force information to ensure that the contact force is maintained within a safe range, thereby improving the automation level and operational safety of the stent in vivo orientation process.

[0017] Furthermore, this application also acquires preoperative images and performs three-dimensional reconstruction to extract the branch vessel opening location and vessel curvature, thereby determining the branch vessel opening direction; then, the orientation information in the pose information is compared with the opening direction to calculate the deviation, and the initial reversal angle and initial reversal speed curve are generated by combining the deviation, vessel curvature, contact force information, and the degree of deviation between the stent imaging point location and the spatial reference path; finally, the pose information, contact force information, vessel curvature, initial reversal angle, and initial reversal speed curve are input into the state discrimination network, and the initial parameters are adjusted according to the output guidewire configuration features to obtain the updated reversal angle and updated reversal speed curve.

[0018] Furthermore, by introducing the fusion processing of preoperative three-dimensional reconstruction data and intraoperative real-time information, and combining the extraction and optimization of guidewire configuration features with a state discrimination network, dynamic correction of the reversal angle and reversal speed curves is achieved, making the generation of reversal parameters more consistent with individual anatomical characteristics and real-time operational status.

[0019] These or other aspects of this application will become more apparent in the following description of the embodiments. Attached Figure Description

[0020] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0021] Figure 1 A flowchart illustrating an in vivo orientation method for vascular stents based on the principle of spatial inversion, provided as an embodiment of this application; Figure 2 A schematic diagram illustrating a specific implementation of an in vivo orientation method for vascular stents based on the principle of spatial inversion, provided in an embodiment of this application; Figure 3 This is a schematic diagram of an in vivo orientation system for a vascular stent based on the principle of spatial reversal, provided as an embodiment of this application. Detailed Implementation

[0022] To address the problems existing in the prior art, this application proposes an in vivo orientation method for vascular stents based on the principle of spatial reversal. Its core lies in the collaborative work of a pose sensing unit and a contact force monitoring unit to collect data on the spatial position, posture angle, and contact force with the vascular wall in real time during the delivery process.

[0023] Specifically, the real-time pose information is first dynamically compared with a pre-established spatial reference path including the vascular centerline to accurately determine whether the delivery system has entered the curved section of the aortic arch. Once the curved section is entered, based on the deviation between the current orientation of the delivery system and the direction of the branch vessel opening, the local vascular curvature, and the real-time contact force information, a continuous reversal speed adjustment is generated. Based on this, the delivery system is controlled to rotate synchronously during its forward movement, so that the orientation of the branch stent is gradually adjusted from the preset orientation to face the opening of the left subclavian artery. At the same time, the forward speed is dynamically adjusted according to the contact force information to ensure that the contact force is maintained within a safe range.

[0024] This method transforms traditional experience-dependent operations into a data-driven closed-loop control mode. Through a collaborative mechanism of real-time perception and dynamic adjustment, the in vivo orientation process of the stent can adapt to individual anatomical differences—avoiding misalignment caused by push posture deviation and eliminating the risk of vascular damage caused by abnormal contact force. It fundamentally solves the problem of difficulty in balancing operational controllability and alignment accuracy in existing technologies, and significantly improves the safety and success rate of aortic arch stent implantation surgery.

[0025] To enable those skilled in the art to better understand the present application, the present application will be further described in detail below with reference to the accompanying drawings and specific embodiments. Obviously, the described embodiments are merely some embodiments of the present application, and not all embodiments. Based on the embodiments in this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0026] The core of this application is to provide a method for in vivo orientation of vascular stents based on the principle of spatial inversion, and a flowchart of one specific implementation is shown below. Figure 1 As shown, the method includes: Step 101: During the process of pushing the delivery system loaded with the main stent along the ultra-rigid guidewire pre-placed in the aorta towards the aortic arch, the positional information of the delivery system and the contact force information between the delivery system and the blood vessel wall are collected. The main stent integrates a branch stent, which is oriented toward the preset position of the femoral artery when loaded externally.

[0027] In step 101, the delivery system is an interventional device assembly for delivering and releasing the main stent to the target location in the aorta. The delivery system includes a push rod, an outer sheath, and a control component detachably connected to the main stent. The pose information is the position and orientation data of the delivery system in space, which describes the real-time spatial state of the delivery system within the aorta. The contact force information is a real-time measurement of the interaction force between the delivery system and the vessel wall, which is used to assess the physical impact of the delivery system on the vessel wall during delivery.

[0028] The main stent is a tubular stent structure for implantation in the aortic arch to repair vascular lesions, and it integrates branch stents; the branch stents are lateral branch structures pre-connected to the main stent, used to enter the left subclavian artery to maintain blood flow in the branch vessel; the preset orientation is the initial orientation of the branch stent relative to the delivery system when loaded externally, and this initial orientation is set to point in the direction of the femoral artery of the access route, so as to take advantage of the anatomical curvature of the aortic arch to allow the branch stent to naturally align with the opening of the left subclavian artery through spatial reversal during the push process.

[0029] In this embodiment, during the process of pushing the delivery system loaded with the main stent along the ultra-rigid guidewire pre-placed in the aorta towards the aortic arch, the original pose data of the delivery system in its own coordinate system is first collected in real time by a sensor integrated at the distal end of the delivery system. This sensor is an electromagnetic positioning sensor or an inertial measurement unit, which can measure the position coordinates and orientation angle of the distal end of the delivery system. Then, the original pose data is converted into a pre-established virtual navigation coordinate system. This virtual navigation coordinate system is constructed by spatially registering the preoperative three-dimensional reconstruction model with the intraoperative images. It includes the spatial reference path of the vessel centerline as a navigation reference, thereby obtaining the real-time pose information of the delivery system in the aortic anatomy. Meanwhile, a force sensor integrated at the far end of the delivery system collects contact force information between the delivery system and the blood vessel wall in real time. This contact force information is used to reflect the physical force exerted by the delivery system on the blood vessel wall during the delivery process. The above-mentioned pose information and contact force information are collected synchronously at a continuous sampling frequency, providing a real-time data basis for subsequent determination of the delivery system entering the curved section of the aortic arch and generating the reversal speed adjustment amount.

[0030] In this embodiment, step 101, acquiring the pose information of the conveying system, includes the following process: Step 1011: Spatial registration is performed between the preoperative 3D reconstruction model and the intraoperative images to establish a virtual navigation coordinate system, which includes the spatial reference path of the vessel centerline.

[0031] In step 1011, the preoperative three-dimensional reconstruction model is constructed by performing three-dimensional reconstruction processing on the patient's preoperative computed tomography angiography images. The specific process is as follows: acquire the patient's preoperative computed tomography angiography image data, which includes a sequence of two-dimensional tomographic images of the aortic region obtained from scanning from different angles. Use a three-dimensional reconstruction algorithm to reconstruct these two-dimensional tomographic image sequences into a three-dimensional model. By segmenting the grayscale threshold of the vessel wall and surrounding tissues, the geometric shape of the aortic lumen is extracted, thereby constructing a three-dimensional anatomical structure model that includes the aortic arch, the opening of the left subclavian artery, and the openings of other branch vessels. Intraoperative images are acquired in real time during the operation using a digital subtraction angiography (DSA) device. The specific process is as follows: During the operation, a contrast agent is injected into the patient's blood vessels. The DSA device emits X-rays that penetrate the patient's body to capture images of the contrast agent filling the blood vessels. Background structures such as bones and soft tissues are removed using digital subtraction technology, leaving only pure vascular images. This allows for the real-time acquisition of two-dimensional perspective images of the aorta and its branches. These intraoperative images are used for spatial registration with the preoperative three-dimensional reconstruction model and to display the position of the delivery system within the blood vessels in real time. Spatial registration is the process of aligning and mapping the spatial coordinate system of the preoperative 3D reconstruction model with the spatial coordinate system of the intraoperative image. The virtual navigation coordinate system is a unified spatial reference frame established after spatial registration. The spatial reference path of the vessel centerline is the planned path extracted along the aortic lumen centerline in the virtual navigation coordinate system. This planned path is used to guide the pushing direction of the delivery system.

[0032] In this embodiment, the patient's preoperative computed tomography angiography image is first acquired, and the image is processed for three-dimensional reconstruction to obtain a three-dimensional model of the aortic arch as the preoperative three-dimensional reconstruction model. Then, digital subtraction angiography images are acquired in real time during the operation as intraoperative images. The preoperative three-dimensional reconstruction model and the intraoperative images are spatially registered. By identifying common anatomical landmarks in both, the spatial transformation matrix is ​​calculated, and the spatial coordinate system of the preoperative three-dimensional reconstruction model is aligned and mapped with the spatial coordinate system of the intraoperative images, thereby establishing a unified virtual navigation coordinate system. In this virtual navigation coordinate system, the centerline of the aortic lumen is extracted from the preoperative 3D reconstruction model and used as the spatial reference path of the vascular centerline for subsequent navigation reference during the delivery system's pushing process.

[0033] Step 1012: Collect the original pose data of the conveying system in the sensor's own coordinate system using a sensor integrated at the far end of the conveying system.

[0034] In step 1012, the sensor is an electromagnetic positioning sensor or inertial measurement unit integrated at the far end of the conveying system. The sensor's own coordinate system is the internal space reference frame defined when the sensor leaves the factory. The original pose data is the position coordinates and orientation angle data directly measured by the sensor in its own coordinate system.

[0035] In this embodiment, an electromagnetic positioning sensor is integrated at the far end of the delivery system. When the delivery system is pushed in the aorta, the electromagnetic positioning sensor measures the position coordinates and orientation angle of the delivery system in its own coordinate system in real time, and collects these measurements as raw pose data.

[0036] Step 1013: Convert the original pose data to the virtual navigation coordinate system to obtain the pose information of the transport system in the virtual navigation coordinate system.

[0037] In this embodiment, the coordinate transformation parameters between the sensor's own coordinate system and the virtual navigation coordinate system are obtained through the spatial registration relationship established in step 1011. The coordinate transformation parameters are applied to the original pose data collected in step 1012 to transform the original pose data from the sensor's own coordinate system to the virtual navigation coordinate system, thereby obtaining the position and orientation data of the delivery system in the virtual navigation coordinate system as pose information.

[0038] In step 101, through steps 1011 to 1013 above, the precise position and orientation of the delivery system in the aortic anatomy are obtained in real time during the pushing process, providing a positioning basis for subsequent spatial reversal control.

[0039] In this embodiment, before step 101, where the delivery system carrying the main stent is pushed along the pre-placed ultra-rigid guidewire into the aortic arch, the following process is also included: A1: Load the main stent with integrated branch stents into the delivery system and orient the branch stents toward the predetermined position of the access femoral artery.

[0040] In step A1, the femoral artery is the puncture site where the delivery system enters the blood vessel.

[0041] In this embodiment of the application, before the delivery system is pushed into the aorta, the main stent with integrated branch stents is first loaded onto the delivery system; during the loading process, the orientation of the branch stent relative to the delivery system is adjusted so that the branch stent points in the direction of the access femoral artery, and this orientation is set as a preset orientation; this preset orientation serves as the initial state for the subsequent spatial reversal process, ensuring that the branch stent is in a known and controllable orientation at the beginning of the pushing stage.

[0042] In this embodiment, before acquiring the pose information of the conveying system in step 101, the following process is also included: B1: A dual-lumen guiding catheter is pre-placed in the aorta. A branched guidewire and an ultra-stiff guidewire are inserted into the dual-lumen guiding catheter. The branched guidewire is led out from the left brachial artery, and the distal end of the ultra-stiff guidewire is located in the ascending aorta.

[0043] In step B1, the double-lumen guiding catheter is a catheter structure with two independent channels inside. The branch guidewire is a guidewire used to guide the branch stent into the left subclavian artery. The ultra-rigid guidewire is a rigid guidewire used to support the delivery path of the delivery system. The left brachial artery is the arterial puncture entry point for the left upper limb. The ascending aorta is the lumen region from the root of the aorta to the beginning of the aortic arch.

[0044] In this embodiment, before the delivery system pushes the stent, the dual-lumen guiding catheter is pre-placed in the aorta through a femoral artery puncture inlet; a branch guidewire is inserted into one lumen of the dual-lumen guiding catheter, and one end of the branch guidewire is led out of the body from the left brachial artery for subsequent traction and guidance of the branch stent; an ultra-rigid guidewire is inserted into the other lumen of the dual-lumen guiding catheter, and the distal end of the ultra-rigid guidewire is pushed to the ascending aorta to provide a pushing support path for the delivery system; the branch guidewire and the ultra-rigid guidewire are constrained in different lumen by the dual-lumen guiding catheter, avoiding the two guidewires from becoming entangled in the aorta.

[0045] Through the above steps, this application completes the preparatory work such as stent loading, guide wire pre-positioning, and navigation coordinate system establishment before the delivery system pushes the stent, laying the operational foundation for subsequent stent in-body orientation based on the principle of spatial reversal.

[0046] Step 102: Compare the pose information with the pre-established spatial reference path to obtain the comparison result. The spatial reference path includes the vascular centerline information.

[0047] In step 102, the spatial reference path is the planned path extracted along the center line of the aortic lumen in the virtual navigation coordinate system. This planned path is used as a spatial position reference during the delivery system's push process. The comparison result is the difference data obtained by comparing the real-time pose information of the delivery system with the spatial reference path. This difference data is used to determine whether the delivery system is currently deviating from the preset navigation path.

[0048] In this embodiment of the application, the pose information of the delivery system in the virtual navigation coordinate system obtained in step 101 is compared with the spatial reference path pre-established in the virtual navigation coordinate system. Specifically, the spatial distance between the position coordinates of the far end of the delivery system and the corresponding position point on the spatial reference path, as well as the angle difference between the orientation angle of the delivery system and the tangent direction of the spatial reference path at that position point, are calculated to obtain a comparison result including position deviation and angle deviation. This comparison result is used to subsequently determine whether the delivery system has entered the curved section of the aortic arch and to evaluate the degree of conformity between the delivery system and the planned path.

[0049] Step 103: When it is determined from the comparison results that the delivery system has entered the curved section of the aortic arch, a continuous reverse speed adjustment is generated and executed based on the deviation between the orientation of the delivery system and the direction of the branch vessel opening, the vessel curvature, and the contact force information.

[0050] Among them, the curved segment of the aortic arch is the segment of the lumen in which the blood vessel direction is significantly curved in the aortic arch region; the direction of the branch vessel opening is the orientation angle of the left subclavian artery opening on the aortic lumen wall; the vascular curvature is a measure of the degree of curvature of the curved segment of the aortic arch in three-dimensional space; the continuous reverse speed adjustment is a rotation speed control parameter that changes continuously with time and is used to control the rotation action performed by the delivery system during the pushing process.

[0051] In this embodiment, step 103 includes the following process, such as... Figure 2 As shown: Step 1031: Obtain preoperative images of computed tomography angiography and perform three-dimensional reconstruction on the preoperative images to obtain a three-dimensional model of the aortic arch.

[0052] In this embodiment, the patient's preoperative computed tomography angiography image data is read. This image data is a two-dimensional tomographic image sequence in DICOM format. A three-dimensional reconstruction algorithm is used to perform voxel reconstruction and surface extraction on the two-dimensional tomographic image sequence. Specifically, the aortic lumen region is segmented using a region growing algorithm, and the surface mesh of the lumen is extracted using a moving cube algorithm. This constructs a three-dimensional model of the aortic arch, which includes the aortic arch, the opening of the left subclavian artery, and the openings of other branch vessels.

[0053] In practical applications, a patient's preoperative computed tomography (CT) angiography image is acquired. This image contains continuous tomographic images from the thoracic inlet to the diaphragm level, with a slice thickness of 1.25 mm. Medical image processing software is used to segment the tomographic images, and the aortic lumen region is extracted with a threshold range of 200 to 500 Henle units. A three-dimensional model of the aortic arch is obtained through three-dimensional reconstruction. This model is presented in the form of a triangular mesh, including the geometry of the ascending aorta, the aortic arch, the descending aorta, and the opening of the left subclavian artery.

[0054] Step 1032: Extract the branch vessel opening locations and vessel curvature from the three-dimensional model of the aortic arch, and determine the branch vessel opening direction based on the branch vessel opening locations and vessel centerline.

[0055] In step 1032, the location of the branch vessel opening is the spatial coordinate point of the opening of the left subclavian artery in the three-dimensional model of the aortic arch; the vessel centerline is a three-dimensional spatial curve extracted along the axis of the aortic lumen; the direction of the branch vessel opening is the orientation angle of the centerline of the lumen at the opening of the left subclavian artery.

[0056] In this embodiment, the centerline of the aorta is first extracted from the three-dimensional model of the aortic arch. Specifically, the spatial curve along the lumen axis is obtained by calculating the skeleton line of the three-dimensional model and used as the centerline of the vessel. Then, the location of the opening of the left subclavian artery is identified. By analyzing the branching situation at each point on the centerline of the vessel, the coordinates of the branch points are used as the opening locations of the branch vessels. Next, discrete sampling is performed along the centerline of the vessel in the curved section of the aortic arch. The directional change between adjacent sampling points is calculated, and the directional change is divided by the arc length between the sampling points to obtain the vessel curvature at each sampling point. Finally, at the opening location of the branch vessels, the tangent direction of the centerline of the left subclavian artery is calculated, and this tangent direction is used as the opening direction of the branch vessels.

[0057] In practical applications, the 3D model of the aortic arch is imported into navigation planning software. The vascular centerline is obtained through a skeleton extraction algorithm. This vascular centerline consists of a series of spatial point coordinates with an adjacent point spacing of 0.5 mm. The intersection of the left subclavian artery and the main aortic trunk is identified, and the coordinates of the branch vessel opening are obtained as [45.2, -12.8, 8.3] mm. The curvature is calculated along the vascular centerline of the curved section of the aortic arch. The three sampling points with the largest curvature are selected, and their curvature values ​​are 0.032, 0.041, and 0.038 per millimeter, respectively. The tangent direction of the vascular centerline at the opening of the left subclavian artery is calculated, and the orientation angle of the branch vessel opening relative to the virtual navigation coordinate system is obtained as an azimuth angle of -35 degrees and a pitch angle of -12 degrees.

[0058] Step 1033: Compare the orientation information in the pose information with the direction of the branch vessel opening, and calculate the deviation between the orientation of the delivery system and the direction of the branch vessel opening.

[0059] In step 1033, the orientation information is the pointing angle of the far end of the delivery system in the virtual navigation coordinate system, and the deviation is the spatial angle difference between the orientation of the delivery system and the direction of the branch blood vessel opening.

[0060] In this embodiment of the application, the orientation information of the far end of the delivery system is extracted from the pose information collected in step 101. The orientation information is represented in Euler angle form. The branch vessel opening direction obtained in step 1032 is compared with the orientation information of the delivery system in terms of spatial angle, and the angle difference between the two is calculated. Specifically, the angle between the two direction vectors is calculated by the vector dot product formula, and the angle is used as the deviation between the orientation of the delivery system and the branch vessel opening direction.

[0061] It should be noted that the specific form of the vector dot product formula is not limited in the embodiments of this application, and can be set accordingly according to the actual situation.

[0062] In practical applications, the orientation information of the distal end of the delivery system is an azimuth of -40 degrees and an elevation of -8 degrees, while the branch vessel opening direction is an azimuth of -35 degrees and an elevation of -12 degrees. Converting both directions into unit vectors, the unit vector for the delivery system orientation is [0.766, -0.643, -0.139], and the unit vector for the branch vessel opening direction is [0.819, -0.574, -0.208]. The cosine of the angle between the two vectors is calculated using the dot product formula, which is 0.988. The inverse cosine yields an angle of 8.5 degrees, which represents the deviation between the delivery system orientation and the branch vessel opening direction.

[0063] Step 1034: Based on the deviation, the vascular curvature, and the contact force information, and combined with the degree of deviation between the stent imaging point position extracted from the preoperative image and the spatial reference path, generate the initial reversal angle and the initial reversal speed curve.

[0064] In step 1034, the position of the developing point of the support is the spatial coordinate of the developing mark point of the branch support on the conveying system in the virtual navigation coordinate system, the degree of deviation is the spatial distance between the position of the developing point of the support and the spatial reference path, the initial reversal angle is the target rotation amount for controlling the rotation of the conveying system, and the initial reversal speed curve is the initial planning curve of the rotation speed changing with time.

[0065] In this embodiment, the location of the imaging point of the branch stent on the delivery system is first identified from the preoperative image. The imaging point location is extracted by an image segmentation algorithm, and the spatial distance between the imaging point location and the spatial reference path is calculated to obtain the degree of deviation. Then, the deviation obtained in step 1033 is used as the main control input, the vascular curvature obtained in step 1032 is used as the path constraint parameter, the contact force information obtained in step 101 is used as the safety constraint parameter, and the degree of deviation is used as the position correction parameter. The initial reversal angle is generated by the proportional-integral-derivative control algorithm, and an initial reversal speed curve matching the curvature distribution of the aortic arch bending segment is generated to adapt the reversal speed to the degree of vascular curvature.

[0066] In practical applications, the location of the visualization point of the branch stent extracted from intraoperative images is [40.5, -15.2, 6.8] mm, and the corresponding location on the spatial reference path is [42.0, -14.5, 7.2] mm. The Euclidean distance between the two points is calculated to be 1.9 mm as the degree of deviation; the deviation is 8.5 degrees, the vascular curvature is 0.038 per millimeter, the contact force information is 0.32 Newtons, the proportional coefficient is set to 1.2, the integral coefficient is 0.05, and the differential coefficient is 0.3. The initial reversal angle is calculated to be 32 degrees using the proportional-integral-derivative control algorithm. Based on the curvature change of the aortic arch bending segment from the starting point to the ending point, the reversal process is divided into three stages. In the first stage, when the curvature is low, the rotation speed is 5 degrees per second; in the second stage, when the curvature is highest, the rotation speed is 15 degrees per second; and in the third stage, when the curvature decreases, the rotation speed is 8 degrees per second. Thus, an initial reversal speed curve containing the correspondence between time and rotation speed is generated.

[0067] Step 1035: Input the pose information, the contact force information, the vascular curvature, the initial reversal angle, and the initial reversal speed curve into a pre-constructed state discrimination network to obtain guidewire configuration features, and adjust the initial reversal angle and the initial reversal speed curve according to the guidewire configuration features to obtain the updated reversal angle and the updated reversal speed curve.

[0068] Among them, the guidewire configuration feature is a feature vector describing the spatial orientation and morphology of the branch guidewire in the aorta, the updated reversal angle is the target rotation amount after correction by the guidewire configuration feature, and the updated reversal speed curve is the curve of the rotation speed changing with time after correction by the guidewire configuration feature.

[0069] The specific examples of the structural design of each module of the state discrimination network are as follows: The state discrimination network adopts a multilayer perceptron structure, specifically including one input layer, three hidden layers, and one output layer. The input layer has 14 nodes and is used to receive the input feature vector composed of position coordinates and orientation angle, contact force information, vascular curvature, initial reversal angle, and the velocity value after discretization of the initial reversal velocity curve from the pose information. The three hidden layers contain 128 nodes, 64 nodes, and 32 nodes, respectively. Each hidden layer is followed by a batch normalization layer to accelerate convergence, and a modified linear unit is used as the activation function. The output layer has 32 nodes and is used to output a 32-dimensional guidewire configuration feature vector. No activation function is set for this output layer to maintain the linear representation of the features.

[0070] During the training process of the model, historical surgical data is first collected as training samples. Each training sample includes an input feature vector and a corresponding guidewire configuration feature label. The guidewire configuration feature label is obtained by experts annotating the guidewire morphology in intraoperative images. The annotation content includes the spatial orientation angle and curvature of the guidewire in the aortic arch, as well as the relative positional relationship between the branch guidewire and the branch vessel opening. The training samples are then divided into training and validation sets. Mean squared error is used as the loss function, and an adaptive moment estimation optimizer is used to update the parameters. The initial learning rate is set to 0.001, the batch size is set to 32, and training is stopped when the loss on the validation set no longer decreases. This results in a trained state discrimination network.

[0071] It should be noted that the above structure is exemplary. This application does not impose specific limitations on the internal structure design of the state discrimination network, and can make corresponding settings according to the actual situation.

[0072] Step 1035 may specifically include the following steps: C1: The pose information, contact force information, vascular curvature, initial reversal angle, and initial reversal speed curve are input into the state discrimination network as input data. The state discrimination network extracts features from the input data and outputs guidewire configuration features. The guidewire configuration features are used to characterize the spatial morphology of the guidewire in the aorta.

[0073] In this embodiment, the pose information obtained in step 101, the contact force information obtained in step 101, the vascular curvature obtained in step 1032, the initial reversal angle obtained in step 1034, and the initial reversal velocity curve obtained in step 1034 are combined into an input feature vector. This input feature vector is then input into a pre-trained state discrimination network. The state discrimination network adopts a multilayer perceptron structure, which includes an input layer, three hidden layers, and an output layer. Each hidden layer contains 128 neurons. After receiving the feature vector, the input layer performs a layer-by-layer nonlinear transformation through the hidden layers, and finally outputs a 32-dimensional feature vector as a guidewire configuration feature. This guidewire configuration feature is used to quantitatively describe the spatial morphology of the branch guidewire in the aorta.

[0074] In practical applications, the position coordinates [42.5, -14.8, 7.1] mm and orientation angles [-38 degrees, -10 degrees] from the pose information, the contact force information of 0.32 N, the vascular curvature of 0.038 mm, the initial reversal angle of 32 degrees, and the eight velocity values ​​after discretization of the initial reversal velocity curve are used as inputs to form an input feature vector containing 14 elements. This input feature vector is then fed into a pre-trained state discrimination network, which learns the mapping relationship between the input parameters and the guidewire morphology through a large amount of historical surgical data during the training phase. After forward computation by the network, a 32-dimensional feature vector is output as the guidewire configuration feature. The value of each dimension in this feature vector is between -1 and 1, which together describe the spatial orientation and curvature of the guidewire in the aortic arch.

[0075] C2: Compare the guidewire configuration features with a preset guidewire configuration reference range to obtain the degree of deviation of the guidewire configuration features from the guidewire configuration reference range.

[0076] In step C2, the guidewire configuration reference range is a pre-set range of spatial morphological characteristics of the guidewire under safe surgical conditions, and the degree of deviation is a measure of the difference between the guidewire configuration characteristics and the guidewire configuration reference range.

[0077] In this embodiment of the application, after outputting the guidewire configuration feature from the state discrimination network, the guidewire configuration feature is compared with the pre-stored guidewire configuration reference range, which is obtained by analyzing the spatial morphology data of guidewires in a large number of successful surgical cases; the Euclidean distance between the guidewire configuration feature vector and the center vector of the guidewire configuration reference range is calculated, and the Euclidean distance is used as the degree of deviation of the guidewire configuration feature from the guidewire configuration reference range.

[0078] In practical applications, the preset guidewire configuration reference range center vector is a 32-dimensional vector, with each dimension having an allowable range of mean plus or minus 0.3 times the standard deviation. The Euclidean distance between the guidewire configuration feature vector output by the state discrimination network and the reference range center vector is calculated, yielding a deviation of 2.3, where this deviation value represents the magnitude of the difference between the current guidewire shape and the ideal shape. This application embodiment does not specifically limit the detailed implementation process for calculating the Euclidean distance; it can be set according to actual conditions.

[0079] C3: Based on the degree of deviation, generate the reversal angle correction amount and the reversal speed curve correction amount.

[0080] In step C3, the reversal angle correction amount is a compensation amount used to adjust the initial reversal angle, and the reversal speed curve correction amount is a compensation amount used to adjust the initial reversal speed curve.

[0081] In this embodiment of the application, the deviation obtained in step C2 is used as input, and the reversal angle correction amount and the reversal speed curve correction amount are generated respectively through a preset proportional mapping relationship; specifically, the deviation is multiplied by the angle correction coefficient to obtain the reversal angle correction amount, and the deviation is multiplied by the speed correction coefficient to obtain the reversal speed curve correction amount.

[0082] In practical applications, with a deviation of 2.3 and an angle correction coefficient of 1.5 degrees per unit deviation, the calculated reversal angle correction is 3.45 degrees; with a speed correction coefficient of 1.2 degrees per second per unit deviation, the calculated reversal speed curve correction is 2.76 degrees per second.

[0083] C4: The reversal angle correction amount is superimposed on the initial reversal angle to obtain the updated reversal angle, and the reversal speed curve correction amount is superimposed on the initial reversal speed curve to obtain the updated reversal speed curve.

[0084] In this embodiment, the reversal angle correction amount generated in step C3 is added to the initial reversal angle generated in step 1034 to obtain the updated reversal angle; the reversal speed curve correction amount generated in step C3 is added to the speed values ​​corresponding to each time point of the initial reversal speed curve generated in step 1034 to obtain the updated reversal speed curve; the updated reversal angle and the updated reversal speed curve are used as the final reversal control parameters to control the rotation of the conveying system in subsequent steps.

[0085] In practical applications, the initial reversal angle is 32 degrees, the reversal angle correction is 3.45 degrees, and the calculated updated reversal angle is 35.45 degrees. The initial reversal speed curve has rotational speeds of 5 degrees per second, 15 degrees per second, and 8 degrees per second in the three stages, respectively. The reversal speed curve correction is 2.76 degrees per second. After summing the corrections, the updated reversal speed curve has rotational speeds of 7.76 degrees per second, 17.76 degrees per second, and 10.76 degrees per second in the three stages, respectively. The above example is only one example of this application. In practical applications, it can be set according to requirements, and this application does not limit it.

[0086] Through the above steps, this application generates initial reversal control parameters based on pose information, vascular anatomy parameters, and contact force information when the delivery system enters the curved section of the aortic arch. The control parameters are then corrected using a state discrimination network based on the guidewire configuration characteristics, thereby achieving adaptive adjustment of the reversal angle and reversal speed curves and improving the accuracy and safety of branch stent positioning.

[0087] Step 104: Based on the continuous reversal speed adjustment, control the delivery system to rotate synchronously during the forward movement, so that the orientation of the branch support is gradually adjusted from the preset orientation to face the opening of the left subclavian artery when passing through the curved section. At the same time, the forward speed is dynamically adjusted according to the contact force information to keep the contact force within the preset safe range.

[0088] The preset safety range is a pre-defined range of allowable values ​​for the contact force between the delivery system and the blood vessel wall. This allowable range is used to ensure that the delivery system does not damage the blood vessel wall during the delivery process.

[0089] In this embodiment, step 104 includes the following process: Step 1041: During the process of the conveying system moving through the curved section along the spatial reference path, the conveying system is controlled to perform rotational actions based on the updated reversal angle as the initial target rotation angle and the updated reversal speed curve as the rotation speed.

[0090] In step 1041, the initial target rotation angle is the updated reverse angle obtained in step 1035, which serves as the final target angle for the conveying system to perform the rotation action.

[0091] In this embodiment, the updated reversal angle obtained in step 1035 is set as the final rotation angle that the conveying system needs to achieve when passing through the curved section, and the updated reversal speed curve obtained in step 1035 is used as a planning reference for the rotation speed. During the movement of the conveying system along the spatial reference path, the required rotation drive command is calculated in real time through the servo control algorithm, so that the actual rotation speed of the conveying system follows the planned value of the updated reversal speed curve. At the same time, with the updated reversal angle as the convergence target, the conveying system is controlled to synchronously perform rotation actions during the forward movement.

[0092] In practical applications, the updated reversal angle is 35.45 degrees, and the rotational speeds of the updated reversal speed curve in the three stages are 7.76 degrees per second, 17.76 degrees per second, and 10.76 degrees per second, respectively. During the conveying process, the controller reads the current rotation angle and rotational speed in real time, compares the current rotational speed with the speed value at the corresponding moment in the updated reversal speed curve, and generates a drive signal through the proportional-integral controller to make the actual rotational speed of the conveying system follow the planned speed curve, while accumulating rotation with 35.45 degrees as the final target angle.

[0093] Step 1042: During the rotation process, the location of the imaging point of the branch stent is extracted from the intraoperative image in real time, and the location of the imaging point is compared with the location of the opening of the left subclavian artery in the virtual navigation coordinate system to obtain the real-time orientation deviation of the imaging point relative to the opening.

[0094] In step 1042, the imaging point position is the spatial coordinate of the imaging marker point of the branch stent on the delivery system in the virtual navigation coordinate system, the left subclavian artery opening position is the spatial coordinate of the left subclavian artery opening in the virtual navigation coordinate system, and the real-time orientation deviation is the spatial offset vector between the imaging point position and the left subclavian artery opening position.

[0095] In this embodiment of the application, while the delivery system is performing a rotational action, intraoperative images are acquired in real time using a digital subtraction angiography device. The location of the imaging point of the branch stent is extracted from the intraoperative images using an image segmentation algorithm. The spatial coordinates of the imaging point location are compared with the location of the opening of the left subclavian artery determined in step 1032, and the coordinate difference between the two in three-dimensional space is calculated to obtain the real-time orientation deviation of the imaging point relative to the opening. The real-time orientation deviation includes the offset in three dimensions: anterior-posterior, left-right, and up-down.

[0096] In practical applications, the coordinates of the visualization point of the branch stent extracted from intraoperative images are [41.2, -13.5, 7.8] mm, and the coordinates of the opening of the left subclavian artery are [42.0, -14.5, 7.2] mm. The difference between the two coordinates is calculated to obtain the real-time orientation deviation as -0.8 mm in the anterior-posterior direction, +1.0 mm in the lateral direction, and +0.6 mm in the vertical direction, where the positive and negative values ​​indicate the offset direction of the visualization point relative to the opening.

[0097] Step 1043: Iteratively correct the initial target rotation angle based on the real-time orientation deviation to obtain the real-time target rotation angle, and control the conveying system to continue performing rotation actions based on the real-time target rotation angle.

[0098] In step 1043, the real-time target rotation angle is the current rotation target value obtained by successively correcting the initial target rotation angle according to the real-time azimuth deviation; the iterative correction is the process of dynamically adjusting the rotation target angle according to the change of the real-time azimuth deviation.

[0099] The termination condition for iterative correction is that the three-dimensional spatial distance between the location of the imaging point and the location of the opening of the left subclavian artery is less than a preset distance threshold, and the component perpendicular to the vascular axis in the real-time orientation deviation of the imaging point relative to the opening is less than a preset angle deviation. At the same time, the anterior edge of the imaging point is in contact with the proximal end of the opening of the left subclavian artery, and the two imaging points on the branch stent overlap each other or are arranged in a figure-eight shape. When all the above conditions are met, the preset alignment condition is determined to be met, and the iterative correction process is terminated.

[0100] In this embodiment, the real-time orientation deviation obtained in step 1042 is used as feedback input, and the correction amount of the rotation angle is calculated by a proportional control algorithm. Specifically, the component of the real-time orientation deviation perpendicular to the blood vessel axis is multiplied by a preset proportional coefficient to obtain the rotation angle correction amount. This rotation angle correction amount is superimposed on the current real-time target rotation angle to obtain the updated real-time target rotation angle. Then, the updated real-time target rotation angle is used as the new control target to continue controlling the delivery system to perform rotation, thereby achieving dynamic approximation between the imaging point position and the opening position of the left subclavian artery.

[0101] In practical applications, the component of the real-time orientation deviation perpendicular to the blood vessel axis is ±1.0 mm in the left and right directions. The set proportional coefficient is 3 degrees per millimeter, and the calculated rotation angle correction is 3.0 degrees. The current real-time target rotation angle is 35.45 degrees. After superimposing this rotation angle correction, the updated real-time target rotation angle is 38.45 degrees. Using 38.45 degrees as the new rotation target, the delivery system continues to rotate, so that the position of the imaging point gradually moves closer to the opening of the left subclavian artery.

[0102] Step 1044: Dynamically adjust the forward speed of the conveying system based on the comparison result between the contact force information and the preset safety range.

[0103] In this embodiment, while the delivery system is performing rotation, the contact force information collected in step 101 is continuously monitored and compared with a preset safety range in real time. When the contact force information is lower than the lower threshold of the preset safety range, it indicates that the delivery system is not making sufficient contact with the blood vessel wall, and the forward speed can be appropriately increased. When the contact force information is higher than the upper threshold of the preset safety range, it indicates that the force applied by the delivery system to the blood vessel wall is too large, and the forward speed is immediately reduced to reduce the contact force. Through this dynamic adjustment mechanism, the contact force is always maintained within the preset safety range to avoid damage to the blood vessel wall.

[0104] In practical applications, the preset safety range is 0.2 to 0.5 Newtons. The current contact force information is 0.32 Newtons, which is within the safety range. The current forward speed is maintained at 2 mm / s. When the conveying system enters the curved section with the maximum curvature, the contact force information rises to 0.55 Newtons, exceeding the upper limit threshold of 0.5 Newtons. The controller reduces the forward speed from 2 mm / s to 1.2 mm / s, causing the contact force information to fall back to 0.48 Newtons, thus returning to the safety range.

[0105] Step 1045: Repeat iterative correction and forward speed adjustment until the position of the imaging point meets the preset alignment condition with the opening of the left subclavian artery, and the orientation of the branch stent is adjusted to be directly opposite the opening of the left subclavian artery.

[0106] In step 1045, the preset alignment condition is that the spatial distance between the imaging point and the opening of the left subclavian artery is less than a preset distance threshold, and the orientation deviation of the imaging point relative to the opening converges to a preset angle range.

[0107] In this embodiment of the application, the iterative correction and forward speed adjustment process of steps 1042 to 1044 is continuously repeated. In each iteration, the real-time orientation deviation gradually decreases and the real-time target rotation angle gradually converges. When the three-dimensional spatial distance between the imaging point position and the opening position of the left subclavian artery is less than a preset distance threshold, and the component perpendicular to the vascular axis in the orientation deviation of the imaging point relative to the opening is less than a preset angle deviation, it is determined that the preset alignment condition is met. At this time, the orientation of the branch stent has been adjusted to be directly opposite the opening position of the left subclavian artery.

[0108] In practical applications, after multiple iterations and corrections, the position of the imaging point is updated to [41.9, -14.4, 7.1] mm, and the spatial distance between it and the opening position of the left subclavian artery [42.0, -14.5, 7.2] mm is 0.2 mm, which is less than the preset distance threshold of 0.5 mm; at the same time, the component of the orientation deviation of the imaging point relative to the opening that is perpendicular to the vascular axis is 0.1 mm, which meets the preset alignment conditions. At this time, the orientation of the branch stent is directly aligned with the opening of the left subclavian artery.

[0109] In this embodiment, after step 104, where the orientation of the branch stent is gradually adjusted from the preset orientation to face the opening of the left subclavian artery as it passes through the curved section, the following process is also included: D1: Withdraw the ultra-rigid guidewire from the dual-lumen guiding cannula, continue to push the main stent along the spatial reference path, and at the same time pull the branch guidewire to guide the branch stent into the opening of the left subclavian artery.

[0110] In this embodiment, after the orientation of the branch stent is adjusted to face the opening of the left subclavian artery, the ultra-rigid guidewire is completely withdrawn from the double-lumen guiding catheter to eliminate the interference of the guidewire with the subsequent pushing of the delivery system; then the main stent is pushed forward along the spatial reference path, while the assistant continuously pulls the branch guidewire outside the body. The branch guidewire is led out from the left brachial artery and passes through the collateral channel of the branch stent. Through the traction action, the branch stent is guided into the opening of the left subclavian artery, realizing the docking of the branch stent with the branch vessel.

[0111] In practical application, the operator withdraws the ultra-rigid guidewire from the dual-lumen guiding cannula. The ultra-rigid guidewire is 260 cm long. Then, the main stent is pushed at a speed of 2 mm / s while the assistant continuously pulls the branch guidewire with a traction force of 0.5 Newtons. The branch guidewire guides the branch stent smoothly into the opening of the left subclavian artery, reaching a depth of 15 mm.

[0112] Specifically, in the coordinated control strategy of branch guidewire traction and main stent pushing, the pushing speed of the main stent and the traction speed of the branch guidewire are synchronously controlled according to a preset linkage ratio. Specifically, the servo motor drives the pushing mechanism to push the main stent at a constant speed, while the force-controlled traction device pulls the branch guidewire in speed mode, so that the traction speed of the branch guidewire is consistent with the pushing speed of the main stent, ensuring that the branch stent does not undergo relative displacement during its entry into the opening of the left subclavian artery. The safe range of traction force is set to 0.2 Newtons to 0.8 Newtons. When the force-controlled traction device detects that the traction force exceeds 0.8 Newtons, it automatically reduces the traction speed and issues an alarm. When the traction force is lower than 0.2 Newtons, it indicates that traction has failed and the branch guidewire position may need to be readjusted. If traction fails and the branch stent fails to enter the ostium, immediately stop pushing and withdraw the branch guidewire. Adjust the orientation angle of the branch stent using the rotation delivery system and try traction again, or use a balloon catheter to assist in dilating the ostium under intraoperative image guidance before attempting traction. During traction, images are acquired in real time using digital subtraction angiography. When the image shows that the visualization point of the branch stent crosses the proximal end of the left subclavian artery ostium and the two visualization points on the branch stent overlap or are arranged in a figure-eight shape, combined with the tactile feedback of the branch guidewire sliding without resistance within the ostium, it is determined that the branch stent has successfully entered the ostium position. At this point, maintain the traction state until the branch stent is fully deployed. The above example is only one example of this application. In actual applications, it can be set according to needs, and this application does not limit it.

[0113] D2: Release the main support and the branch support in sequence.

[0114] In this embodiment, after the branch stent enters the opening of the left subclavian artery, the main stent is first released from the delivery system by rotating the control nut on the release handle, so that the main stent unfolds in the aorta and conforms to the vessel wall; then, the branch stent is released from the collateral structure of the main stent by pulling the branch guidewire externally, so that the branch stent unfolds in the left subclavian artery, completing the sequential release of the main stent and the branch stent, and realizing the endovascular repair of the aortic arch lesion.

[0115] In practical applications, the operator first rotates the control nut on the blue handle and quickly pulls the control guidewire to release the main stent. After the main stent unfolds in the aortic arch, it adheres tightly to the vessel wall. Then, the assistant continues to pull the branch guidewire, and the branch stent is released from the side branch of the main stent and unfolds in the left subclavian artery, thus completing the stent implantation.

[0116] Through the above steps, this application introduces a real-time feedback mechanism for the location of the imaging point and a dynamic adjustment mechanism for the contact force during the spatial reversal process, thereby achieving closed-loop precise control of the orientation of the branch stent and completing the precise alignment of the branch stent and the branch vessel while ensuring the safety of the blood vessel.

[0117] Figure 3 A schematic diagram of an in vivo orientation system for vascular stents based on the principle of spatial inversion is provided for an embodiment of this application, as shown below. Figure 3 As shown, the system includes: The acquisition module 31 is used to acquire the position information of the delivery system and the contact force information between the delivery system and the blood vessel wall during the process of pushing the delivery system loaded with the main stent along the ultra-hard guidewire pre-placed in the aorta to the aortic arch. The main stent integrates a branch stent, which is oriented toward a preset position of the femoral artery when loaded externally.

[0118] The comparison module 32 is used to compare the pose information with a pre-established spatial reference path to obtain a comparison result. The spatial reference path includes the blood vessel centerline information.

[0119] The generation module 33 is used to generate and execute a continuous reverse speed adjustment amount based on the deviation between the orientation of the delivery system and the opening direction of the branch vessels, the curvature of the vessels, and the contact force information when it is determined from the comparison result that the delivery system has entered the curved section of the aortic arch.

[0120] The control module 34 is used to control the delivery system to rotate synchronously during forward movement based on the continuous reverse speed adjustment, so that the orientation of the branch support is gradually adjusted from the preset orientation to face the opening of the left subclavian artery when passing through the curved section. At the same time, the forward speed is dynamically adjusted according to the contact force information to keep the contact force within a preset safe range.

[0121] The in vivo stent orientation system based on the spatial inversion principle in this application embodiment is used to implement the aforementioned in vivo stent orientation method based on the spatial inversion principle. Therefore, the specific implementation of the in vivo stent orientation system based on the spatial inversion principle can be found in the embodiment section of the in vivo stent orientation method based on the spatial inversion principle above. The specific implementation can be referred to the description of the corresponding embodiments, and will not be repeated here.

[0122] This application also provides a computer-readable storage medium storing a computer program, which, when executed by a processor, implements the steps of any of the above-described methods for in vivo orientation of vascular stents based on the principle of spatial inversion.

[0123] In one exemplary embodiment, the aforementioned computer-readable storage medium may include, but is not limited to, various media capable of storing computer programs, such as USB flash drives, read-only memory, random access memory, portable hard drives, magnetic disks, or optical disks.

[0124] The embodiments of this application also provide a computer program product, which includes a computer program that, when executed by a processor, implements the steps in any of the embodiments of the in vivo orientation method for vascular stents based on the spatial inversion principle.

[0125] Those skilled in the art will further recognize that the units and algorithm steps of the various examples described in conjunction with the embodiments disclosed herein can be implemented in electronic hardware, computer software, or a combination of both. To clearly illustrate the interchangeability of hardware and software, the components and steps of the various examples have been generally described in terms of functionality in the foregoing description. Whether these functions are implemented in hardware or software depends on the specific application and design constraints of the technical solution. Those skilled in the art can use different methods to implement the described functions for each specific application, but such implementation should not be considered beyond the scope of this application.

[0126] It should be noted that the user information (including but not limited to user device information, user personal information, etc.) and data (including but not limited to data used for analysis, data stored, data displayed, etc.) involved in one or more embodiments of this specification are all information and data authorized by the user or fully authorized by all parties. Furthermore, the collection, use and processing of related data must comply with relevant laws, regulations and standards, and corresponding operation entry points are provided for users to choose to authorize or refuse.

[0127] The foregoing has provided a detailed description of the in vivo orientation method and system for vascular stents based on the principle of spatial inversion provided in this application. Specific examples have been used to illustrate the principles and implementation methods of this application. The descriptions of the embodiments above are merely for the purpose of helping to understand the method and its core ideas. It should be noted that those skilled in the art can make various improvements and modifications to this application without departing from its principles, and these improvements and modifications also fall within the protection scope of this application.

Claims

1. A method for in vivo orientation of vascular stents based on the principle of spatial inversion, characterized in that, include: During the process of pushing the delivery system loaded with the main stent along the ultra-rigid guidewire pre-placed in the aorta towards the aortic arch, the positional information of the delivery system and the contact force information between the delivery system and the blood vessel wall are collected. The main stent integrates a branch stent, which is oriented toward the preset position of the femoral artery when loaded externally. The pose information is compared with a pre-established spatial reference path to obtain a comparison result. The spatial reference path includes the vascular centerline information. When the delivery system is determined to have entered the curved section of the aortic arch based on the comparison results, a continuous reverse speed adjustment is generated and executed based on the deviation between the orientation of the delivery system and the direction of the branch vessel opening, the vessel curvature, and the contact force information. Based on the continuous reversal speed adjustment, the delivery system is controlled to rotate synchronously during forward movement, so that the orientation of the branch support is gradually adjusted from the preset orientation to face the opening of the left subclavian artery when passing through the curved section. At the same time, the forward speed is dynamically adjusted according to the contact force information to keep the contact force within a preset safe range.

2. The method according to claim 1, characterized in that, The reversal speed adjustment includes the reversal angle and the reversal speed curve; Based on the deviation between the orientation of the delivery system and the direction of the branch vessel opening, the vessel curvature, and the contact force information, a continuous reversal speed adjustment is generated and executed, including: Preoperative images of computed tomography angiography were acquired, and a three-dimensional model of the aortic arch was obtained by three-dimensional reconstruction of the preoperative images. The branch vessel opening locations and vessel curvature are extracted from the three-dimensional model of the aortic arch, and the branch vessel opening directions are determined based on the branch vessel opening locations and vessel centerlines. The orientation information in the pose information is compared with the direction of the branch vessel opening to calculate the deviation between the orientation of the delivery system and the direction of the branch vessel opening. Based on the deviation, the vessel curvature, and the contact force information, and combined with the degree of deviation between the stent imaging point position extracted from the preoperative image and the spatial reference path, an initial reversal angle and an initial reversal speed curve are generated. The pose information, contact force information, vascular curvature, initial reversal angle, and initial reversal speed curve are input into a pre-constructed state discrimination network to obtain guidewire configuration features. The initial reversal angle and the initial reversal speed curve are adjusted according to the guidewire configuration features to obtain the updated reversal angle and the updated reversal speed curve.

3. The method according to claim 2, characterized in that, The step of inputting the pose information, contact force information, vascular curvature, initial reversal angle, and initial reversal speed curve into a pre-constructed state discrimination network to obtain guidewire configuration features, and adjusting the initial reversal angle and initial reversal speed curve according to the guidewire configuration features to obtain updated reversal angle and updated reversal speed curve, includes: The pose information, contact force information, vascular curvature, initial reversal angle, and initial reversal speed curve are input into the state discrimination network as input data. The state discrimination network extracts features from the input data and outputs guidewire configuration features. The guidewire configuration features are used to characterize the spatial morphology of the guidewire in the aorta. The guidewire configuration feature is compared with a preset guidewire configuration reference range to obtain the degree of deviation of the guidewire configuration feature from the guidewire configuration reference range; Based on the degree of deviation, a reversal angle correction amount and a reversal speed curve correction amount are generated; The reversal angle correction is superimposed on the initial reversal angle to obtain the updated reversal angle, and the reversal speed curve correction is superimposed on the initial reversal speed curve to obtain the updated reversal speed curve.

4. The method according to claim 1, characterized in that, The method of controlling the delivery system to rotate synchronously during forward movement based on the continuous reversal speed adjustment, so that the orientation of the branch support gradually adjusts from the preset orientation to face the opening of the left subclavian artery when passing through the curved section, and simultaneously dynamically adjusts the forward speed according to the contact force information to maintain the contact force within a preset safe range, including: During the process of the conveying system moving through the curved section along the spatial reference path, the updated reversal angle is used as the initial target rotation angle and the updated reversal speed curve is used as the rotation speed basis to control the conveying system to perform rotational actions. During the rotation process, the location of the visualization point of the branch stent is extracted from the intraoperative images in real time. The location of the visualization point is compared with the location of the opening of the left subclavian artery in the virtual navigation coordinate system to obtain the real-time orientation deviation of the visualization point relative to the opening. The initial target rotation angle is iteratively corrected based on the real-time orientation deviation to obtain the real-time target rotation angle, and the conveying system is controlled to continue performing rotation actions based on the real-time target rotation angle. The forward speed of the conveying system is dynamically adjusted based on the comparison result between the contact force information and the preset safety range. Repeated iterative corrections and forward speed adjustments are made until the position of the imaging point meets the preset alignment condition with the opening of the left subclavian artery, and the orientation of the branch stent is adjusted to be directly opposite the opening of the left subclavian artery.

5. The method according to claim 1, characterized in that, Collecting the pose information of the conveying system includes: The preoperative three-dimensional reconstruction model is spatially registered with the intraoperative images to establish a virtual navigation coordinate system, which includes the spatial reference path of the vessel centerline. The original pose data of the conveying system in the sensor's own coordinate system is collected by a sensor integrated at the far end of the conveying system. The original pose data is converted to the virtual navigation coordinate system to obtain the pose information of the transport system in the virtual navigation coordinate system.

6. The method according to claim 1, characterized in that, Before the delivery system, which carries the main stent, is advanced along the pre-placed ultra-rigid guidewire into the aortic arch, it also includes: The main stent, which integrates the branch stent, is loaded into the delivery system, and the branch stent is oriented toward a predetermined position of the access femoral artery.

7. The method according to claim 1, characterized in that, Before collecting the pose information of the conveying system, the following steps are also included: A dual-lumen guiding catheter is pre-placed in the aorta. A branched guidewire and an ultra-stiff guidewire are threaded through the dual-lumen guiding catheter. The branched guidewire is led out from the left brachial artery, and the distal end of the ultra-stiff guidewire is located in the ascending aorta.

8. The method according to claim 1, characterized in that, After the orientation of the branch stent is gradually adjusted from the preset orientation to be directly opposite the opening of the left subclavian artery as it passes through the curved section, the method further includes: The ultra-rigid guidewire is withdrawn from the dual-lumen guiding cannula, and the main stent is continued to be pushed along the spatial reference path. At the same time, the branch guidewire is pulled to guide the branch stent into the opening of the left subclavian artery. Release the main support and the branch support in sequence.

9. A vascular stent in vivo orientation system based on the principle of spatial reversal, characterized in that, include: The acquisition module is used to acquire the position and orientation information of the delivery system and the contact force information between the delivery system and the blood vessel wall during the process of pushing the delivery system loaded with the main stent along the ultra-rigid guidewire pre-placed in the aorta to the aortic arch. The main stent integrates a branch stent, which is oriented toward the preset position of the femoral artery when loaded externally. The comparison module is used to compare the pose information with a pre-established spatial reference path to obtain a comparison result. The spatial reference path includes the blood vessel centerline information. The generation module is used to generate and execute a continuous reverse speed adjustment amount based on the deviation between the orientation of the delivery system and the opening direction of the branch vessels, the curvature of the vessels, and the contact force information when it is determined from the comparison results that the delivery system has entered the curved section of the aortic arch. The control module is used to control the delivery system to rotate synchronously during forward movement based on the continuous reversal speed adjustment, so that the orientation of the branch support is gradually adjusted from the preset orientation to face the opening of the left subclavian artery when passing through the curved section. At the same time, the forward speed is dynamically adjusted according to the contact force information to keep the contact force within a preset safety range.

10. A computer-readable storage medium, characterized in that, The computer-readable storage medium stores a computer program that, when executed by a processor, enables the in vivo orientation method for vascular stents based on the spatial inversion principle as described in any one of claims 1 to 8.

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