An angioplasty system and device for use with femoral vein tricuspid valves

Abstract

The embodiment of the specification provides a shaping system and device applied to femoral vein tri-leaflet valve, relates to the intelligent medical field, and comprises the following modules: an operation field image acquisition module configured to acquire an operation field image of a first pair of venous valves that have been exposed in the operation of repairing the femoral vein valve; a valve leaflet morphology judgment module configured to analyze the number of valve leaflets and at least one morphological feature of the first pair of valves according to the operation field image, when the number of valve leaflets is three, select a target valve leaflet from the three valve leaflets according to the at least one valve leaflet morphological feature, wherein the target valve leaflet is a smaller or obviously poorly developed valve leaflet determined according to the comprehensive judgment of size and development degree; and a resection module configured to resect the target valve leaflet. The application explores the shaping operation treatment strategy after the tri-leaflet valve is reduced to a bi-leaflet valve for the repair operation mode of the femoral vein tri-leaflet valve insufficiency.

Description

Technical Field

[0001] This invention relates to the field of intelligent medical care, and more specifically, to a shaping system and apparatus for a femoral vein tricuspid valve. Background Technology

[0002] Femoral vein valve insufficiency is a pathological condition in which the valves in the femoral vein cannot close normally, leading to blood reflux. It mainly includes two types: primary and secondary valve insufficiency. In primary valve insufficiency, abnormal valve structure is a common type, such as abnormal number of leaflets (e.g., bicuspid or tricuspid valves), or congenital developmental abnormalities such as leaflet misalignment, which lead to abnormal valve morphology, preventing the valve from closing normally and causing blood reflux.

[0003] Tricuspid valves occur in only 7.1% of femoral veins (Clinical Application Anatomy of Femoral Vein Valve, Nie Bing, Wen Yu, Dang Ruishan, Huang Huilong, Wang Dong, Zhang Zhiying, et al.). Their functional degeneration can lead to deep vein reflux (DVR), causing chronic venous disease (CVD). Based on guideline recommendations and previous clinical experience, surgical intervention is a necessary treatment option for patients with severe DVR, such as those with CEAP clinical classifications C4-C6 and Kistner III and IV. Currently, valve repair techniques for common bicuspid valves (such as endovascular or extravascular valve repair) are relatively mature, but methods for repairing tricuspid valves have not yet been reported. Summary of the Invention

[0004] This invention aims to at least solve one of the technical problems existing in the prior art. To this end, this invention provides a system and apparatus for the reconstruction of the femoral vein tricuspid valve, and, for the repair of femoral vein tricuspid valve insufficiency, explores a surgical treatment strategy for the reconstruction of the tricuspid valve into a bicuspid valve, providing insights into the treatment of diseases caused by this anatomical variation.

[0005] The first aspect of this application discloses a system for the creation of a femoral vein tricuspid valve, comprising: The surgical field image acquisition module is configured to acquire surgical field images in which the first pair of venous valves have been exposed during the femoral vein valve repair surgery; The leaflet morphology judgment module is configured to analyze the number of leaflets and at least one morphological feature of the first pair of valves based on the surgical field image. When the number of leaflets is 3, a target leaflet is selected from the 3 leaflets based on the at least one leaflet morphological feature. The target leaflet is a smaller or significantly underdeveloped leaflet determined based on a comprehensive judgment of size and development degree. The ablation module is configured to ablate the target leaflet.

[0006] A second aspect of this application also discloses an apparatus for shaping a femoral vein tricuspid valve, the apparatus comprising: one or more processors and a memory; the memory for storing one or more computer programs; and, when the one or more computer programs are executed by the one or more processors, performing the following steps: S101, Obtain surgical field images showing the first pair of venous valves during femoral vein valve repair surgery; S102, based on the surgical field image analysis, the number of leaflets and at least one morphological feature of the first pair of valves are analyzed. When the number of leaflets is 3, a target leaflet is selected from the 3 leaflets based on the at least one leaflet morphological feature. The target leaflet is a smaller or significantly underdeveloped leaflet determined based on a comprehensive judgment of size and development degree. S103, the target leaflet is removed.

[0007] This application has the following beneficial effects: This application innovatively proposes a novel surgical technique that is only applicable to rare cases of tricuspid valves. By cleverly reducing the valve size, the tricuspid valve is transformed into a bicuspid valve, achieving a high mid- to long-term effectiveness rate after bicuspid valve repair.

[0008] In addition, this application differs from existing valve repair surgery methods that retain the original number of leaflets or directly repair the function of the leaflets. Instead, it achieves repair by reducing the number of leaflets (changing the tricuspid valve to a bicuspid valve). Attached Figure Description

[0009] To more clearly illustrate the technical solutions in the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0010] Figure 1 This is a schematic diagram of the shaping system for the femoral vein tricuspid valve provided in an embodiment of the present invention; Figure 2 This is a schematic diagram illustrating the patient's condition and preoperative preparation provided in an embodiment of the present invention; wherein, Figure 2 In this context, A represents the patient's preoperative physical signs. Figure 2 In the image, B represents the patient performing the Valsalva maneuver, where ultrasound revealed reflux of the first group of venous valves in the superficial femoral vein. Figure 2 C in the image shows retrograde venography revealing deep vein reflux reaching below the knee level (Kistner grade III). Figure 2 In the image, D indicates the location of the first group of valves in the superficial femoral vein, as shown by the arrow. Figure 3This is a schematic diagram of the surgical procedure and postoperative evaluation provided in an embodiment of the present invention; Figure 3 In the image, A represents the incision of the superficial femoral vein to expose the first pair of valves, which were found to be tricuspid valves. Figure 3 B in the diagram is a schematic diagram, showing: ① resection of the right valve; ② and ③ reconstruction of the attachment margin. Figure 3 In the diagram, C represents the bilateral attachment edges suspending the two valves to a suitable position. Figure 3 D in the diagram represents the schematic diagram. Figure 3 In the figure, E indicates that no reflux of the first group of superficial femoral vein valves was observed on ultrasound when the patient performed the Valsalva maneuver. Detailed Implementation

[0011] To enable those skilled in the art to better understand the present invention, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings.

[0012] In some of the processes described in the specification, claims, and accompanying drawings of this invention, multiple operations appearing in a specific order are included. However, it should be clearly understood that these operations may not be executed in the order they appear herein, or may be executed in parallel. The operation numbers, such as 101, 102, etc., are merely used to distinguish different operations and do not represent any execution order. Furthermore, these processes may include more or fewer operations, and these operations may be executed sequentially or in parallel. It should be noted that the descriptions such as "first," "second," etc., in this document are used to distinguish different messages, devices, modules, etc., and do not represent a sequential order, nor do they limit "first" and "second" to different types.

[0013] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0014] First, it is worth noting that, in this field, the basic structural knowledge of the femoral vein valve is as follows: Femoral vein valve: refers to a complete structure within the femoral vein that functions as a one-way valve. It consists of valve leaflets, valve sinuses, and attachment margins, and is a functional unit that ensures unidirectional blood return. Overall, it is crescent-shaped or pouch-shaped, attached to the vein wall. The vein wall bulges near the valve attachment margin to form valve sinuses, which hold blood to facilitate valve leaflet closure.

[0015] Leaflets: These are components of the femoral vein valve, typically a pair of crescent-shaped or pouch-like thin plates that open and close to close the valve. Each leaflet has a free edge and an attached edge. The free edges come together when the valve is closed to form a seal, preventing backflow of blood.

[0016] Figure 1 This is a schematic diagram of a prosthetic system for a femoral vein tricuspid valve provided in an embodiment of the present invention. Specifically, the system can be performed by a robot and includes: The surgical field image acquisition module 201 is configured to acquire surgical field images in which the first pair of venous valves have been exposed during the femoral vein valve repair surgery. In some embodiments, the objects of operation herein include, but are not limited to, humans, non-human primates, rodents, etc., who will become recipients of a specific treatment.

[0017] In some embodiments, surgical field images exposing the first pair of venous valves are obtained using routine clinical methods, such as: exposing the left common femoral vein, deep femoral vein, and superficial femoral vein sequentially through a longitudinal incision in the groin. Clear valve sinus structures are visible in the proximal segment of the superficial femoral vein, and a positive Strip test indicates significant regurgitation. Subsequently, the superficial femoral vein is longitudinally incised along the vessel, avoiding damage to the internal valves, to expose the first pair of venous valves.

[0018] The leaflet morphology judgment module 202 is configured to analyze the number of leaflets and at least one morphological feature of the first pair of valves based on the surgical field image. When the number of leaflets is 3, a target leaflet is selected from the 3 leaflets based on the at least one leaflet morphological feature. The target leaflet is a smaller or significantly underdeveloped leaflet determined based on a comprehensive judgment of size and development degree. In some embodiments, the comprehensive judgment includes: extracting the edges of the three leaflets respectively to obtain the dimensions of the three leaflets, comparing the dimensions of the three leaflets, and selecting the leaflet with the smallest size as the target leaflet.

[0019] In some embodiments, the comprehensive judgment includes: extracting the edges of the three leaflets respectively to obtain the dimensions of the three leaflets, and determining whether the dimension of the first leaflet is less than the average dimension of the second and third leaflets. If so, the first leaflet is taken as the target leaflet.

[0020] In some embodiments, the determination of the degree of development is based on the shape and size of the leaflet, the structure of the corresponding sinus, or a combination thereof.

[0021] The ablation module 203 is configured to ablate the target leaflet.

[0022] In some embodiments, the system further includes: The remaining leaflet reconstruction module 204 is configured to reconstruct the attachment edges of the remaining two leaflets under direct intracavitary visualization; the attachment lines of the remaining two leaflets are adjusted by bilateral suspension to ensure that the height and mating surfaces of the two leaflets meet the requirements of symmetry and stability; in some more specific embodiments, the reconstruction is performed using Prolene lines.

[0023] The suture module 205 is configured to control the suturing of venous incisions.

[0024] In some embodiments, the system further includes an installation navigation system, the installation navigation system comprising: The step-by-step guidance module is configured to provide real-time prompts for the sequence of surgical steps; The operation monitoring unit is configured to acquire surgical field image data via an image monitoring device; The early warning module is configured to generate early warning information and trigger audible and visual alerts in response to the triggering of early warning conditions; The processing module is configured as follows: Based on the surgical field image data, the instrument positions and valve characteristics within the surgical field are tracked and acquired. Based on the instrument location and valve characteristics, the surgical steps are updated and displayed to the user using the step guidance module.

[0025] A second aspect of this application discloses an angioplasty device for a femoral vein tricuspid valve, the device comprising: one or more processors and a memory; the memory for storing one or more computer programs; and the following steps performed when the one or more computer programs are executed by the one or more processors: By retrieving the computer program from the memory and using the processor to perform S101, an image of the surgical field in which the first pair of venous valves has been exposed during the femoral vein valve repair surgery is obtained. By retrieving the computer program from the memory and using the processor to perform S102, the number of leaflets and at least one morphological feature of the first pair of valves are analyzed based on the surgical field image. When the number of leaflets is 3, a target leaflet is selected from the 3 leaflets based on the at least one leaflet morphological feature. The target leaflet is a smaller or significantly underdeveloped leaflet determined based on a comprehensive judgment of size and development degree. The target leaflet is removed by using the processor in step S103, which involves retrieving the computer program from the memory; By retrieving the computer program from the memory and using the processor to perform S104, under direct intracavitary visualization, the attachment edges of the remaining two leaflets are reconstructed; the attachment lines of the remaining two leaflets are adjusted by bilateral suspension to ensure that the height and occlusal surface of the two leaflets meet the requirements of symmetry and stability; the venous incision is sutured. In some embodiments, the device includes: a scalpel, scissors, hemostatic forceps, suture needles, and sutures, etc.

[0026] In one embodiment, the system does not involve direct surgical procedures on the human body; it achieves automated and / or semi-automated execution of the surgical robot's actions solely through computer instructions or programs and hardware control. In this embodiment, the system deployment primarily includes two methods: built-in deployment and external deployment to control the execution of each unit. Built-in deployment: Integrated into the central processor of the surgical robot, serving as a core functional module of the robot control system; External deployment: As an independent control system, it interacts with surgical robots / robotic arms through standardized data interfaces.

[0027] In a fully automated process, the surgical robot autonomously completes the entire process control, including image data acquisition, recognition, and suturing, based on preset computer instructions or program sets. Specifically, this includes: The image acquisition unit acquires real-time image data of the surgical area, the image recognition unit automatically identifies the lowest point, endpoints and other feature points of the target suturing area, the computing unit calculates the optimal operating angle, operating distance and other motion parameters according to the preset algorithm, and the control unit sends motion commands to the robot / robotic arm to execute the fully automatic suturing operation.

[0028] In semi-automated processes, robots or robotic arms perform semi-automated process control under the guidance of doctors or other medical staff, specifically including: Image recognition and data transmission: The system uses the image recognition unit to identify and locate the lowest point and each endpoint in the real-time image, and synchronously transmits the coordinates of the feature points and image data to the display device of the doctor's operating terminal; Manual verification and parameter adjustment: Medical staff view real-time images and feature points through display devices to determine whether the coordinates of the points need to be adjusted; if adjustment is needed, they input correction parameters through the input interface of the operating terminal (such as touch screen, keyboard and mouse, voice commands); if no adjustment is needed, they input the command to continue the operation through the input interface of the operating terminal (such as touch screen, keyboard and mouse, voice commands). Parameter calculation and command generation: After receiving the corrected parameters, the system automatically recalculates motion parameters such as operating angle and operating distance, and generates new control commands; Closed-loop verification and confirmation: The system feeds back the corrected parameters and simulated motion path to the display device. After the medical staff confirms that there are no errors, they send an execution command to the system. Robotic arm execution: The robot / robotic arm receives the final control command and performs precise suturing operations.

[0029] In this embodiment, to more clearly describe the clinical processing of the system of this application, a specific case is used as an example for illustrative description. However, this description is only one use case and is not intended to limit the scope of protection of the system or method. Those skilled in the art will understand that the content of this embodiment, in addition to the specific case described below, can be extended to other tricuspid valve case scenarios, as specifically illustrated below: 1. Patient condition and preoperative assessment The patient is a 73-year-old male. He has had lumbrical vein protrusions in his left lower extremity for over 20 years, with symptoms worsening in the past 3 months, accompanied by itching, swelling, and a feeling of heaviness. Lipid sclerosis has appeared on the skin of his left ankle and the lower third of his calf. Physical examination revealed mild pitting edema. Figure 2 (A) The revised Venous Clinical Severity Score (rVCSS) was 11 points. Doppler ultrasound indicated that during the Valsalva maneuver, regurgitation of the first group of valves in the superficial femoral vein lasted for >2 seconds, located approximately 0.17 cm from the bifurcation. Figure 2 B in the text). Retrograde venography showed deep vein reflux reaching below the knee level. Figure 2 Based on the above findings (C in the chart), which conforms to Kistner grade III reflux, the patient is diagnosed with left lower extremity deep vein valve insufficiency, CEAP classification C4bEpAsdPr. Femoral vein valve repair surgery is planned. Figure 2 The arrow pointing to D in the diagram indicates the location of the first group of valves in the superficial femoral vein.

[0030] 2. Surgical procedure 2.1. Exposure and Preliminary Assessment A longitudinal incision was made in the groin to expose the left common femoral vein, deep femoral vein, and superficial femoral vein in sequence. Clear valve sinus structures were visible in the proximal segment of the superficial femoral vein, and the Strip test was positive, indicating significant regurgitation. Subsequently, avoiding damage to the internal valves, the superficial femoral vein was longitudinally incised along the vessel to expose the first pair of venous valves.

[0031] 2.2 Valve morphological characteristics Intraoperative findings revealed a rare tricuspid valve structure: the posterior leaflet free edge was significantly elongated; the right leaflet and its sinuses were short; the left leaflet and its sinuses had normal structures. Figure 3 (A) The three lobes are severely asymmetrical in position and size, and the occlusal surfaces cannot form stable contact, indicating that physiological closure is difficult to achieve, which is the main reason for the patient's severe regurgitation.

[0032] 2.3 Reduction Valvuloplasty (formed by reducing the trilobal lobes to bilobals) Because the deformed tricuspid valve could not provide effective closure, the short right lobule was excised. Under direct intracavitary visualization, the attachment margins of the left and posterior lobes were reconstructed using 6-0 Prolene sutures. Figure 3 (B in the text). Subsequently, the attachment lines of the two petals were adjusted by bilateral suspension to ensure that the height and mating surfaces of the two petals were symmetrical and stable. Figure 3 (C and D in the diagram), thus achieving the conversion from a tricuspid valve to a bicuspid valve. After confirming complete occlusion, suture the venous incision. A second Strip test showed no valve regurgitation.

[0033] 3. Postoperative management The patient recovered well. Postoperatively, enoxaparin anticoagulation was administered for 3 days, followed by oral rivaroxaban for 3 months. Postoperative itching in the left lower extremity quickly subsided. The patient was discharged one week postoperatively, reporting reduced heaviness, disappearance of varicose veins, and a decrease in rVCSS score to 5. Follow-up Doppler ultrasound showed no significant reflux after the patient performed the Valsalva maneuver. Figure 3 (E in the text)

[0034] In addition, this embodiment needs to explain several common valve repair surgical methods: 1. Endovascular valve repair (Procedure 1). This procedure is the most classic and commonly used, offering precise repair, but it has relatively high technical requirements and operational difficulty, making it difficult for inexperienced surgeons to master quickly. Related studies show that the 5-year effectiveness and ulcer healing rate of endovascular repair are 50%–70%, while the recurrence or ulcer non-healing rate is 30%–50%.

[0035] 2. In situ wrapping of the extravascular valve (procedure 2). This procedure is simple and does not involve incising the lumen, but its effectiveness is uncertain and it may cause luminal stenosis. It is generally only used for valves with primary dysfunction and is not suitable for valves already damaged by thrombosis or other factors. It can also be used in combination with endovascular angioplasty.

[0036] 3. Extravascular repair (procedure 3). This procedure eliminates the need for venous incision, shortening the operation time and reducing related complications. However, direct visualization of the valve is not possible during the procedure; therefore, the precision of extravascular repair is not as high as endovascular repair. The results may be more accurate with the aid of angioscopy.

[0037] 4. Vein transposition (procedure 4). This procedure is less commonly used and has a high mid- to long-term recurrence rate. Transposition of superficial veins to deep veins is rare, while transposition of deep veins to superficial veins places a heavy burden on the valves and has a high mid- to long-term recurrence rate. It is generally used for secondary valve insufficiency where valve repair is not possible, and not for primary deep vein valve insufficiency.

[0038] 5. Venous valve transplantation (procedure 5). This procedure typically involves transplanting axillary or brachial veins to the femoral or popliteal veins. The advantage of valve transplantation is that it directly introduces a normal valvular system, avoiding the risks associated with repairing existing valves. In limited retrospective reports, the effectiveness of venous valve transplantation fluctuates between 30% and 80%, and its symptom relief rate and duration of effectiveness are inferior to endovascular repair.

[0039] The above surgical procedures are basically the commonly used surgical methods for lower extremity venous valve insufficiency. For common primary lower extremity venous valve insufficiency, procedure 1 is mostly used, with procedures 2 and 3 rarely employed. Procedures 4 or 5 are only used after repair failure, solely for the purpose of long-term functional preservation (anti-reflux performance). For valvular insufficiency secondary to lower extremity deep vein thrombosis, due to valve damage, direct repair procedures 1 and 3 are not feasible, and procedure 2's effectiveness is uncertain; therefore, procedures 4 or 5 are often used. For patients with congenital absence of valves, only procedures 4 or 5 can be used. It is evident that each surgical procedure has its unique indications.

[0040] The above surgical techniques are commonly used for the repair and reconstruction of bicuspid valves. Based on the tracking of the surgical outcomes of bicuspid valves, technique 1 has the highest mid-to-long-term effectiveness (anti-regurgitation performance), and is therefore the most widely used. For the rare tricuspid valve repair, techniques 2, 4, or 5 are available; the lack of a commonly used technique 1 similar to bicuspid valve repair suggests that the mid-to-long-term effectiveness will not be very good. The principles of techniques 1 and 3 are the shortening and tightening of the bicuspid valve; applying the same principle to tricuspid valves will only widen the regurgitation gap with each repair. Therefore, this technique is an innovative one with unique indications and is not suitable for the surgical treatment of bicuspid valves.

[0041] In this embodiment, Doppler ultrasound initially determined the presence of regurgitation and the location of the dysfunctional valve. Retrograde venography is the gold standard for assessing valve function, used to determine the extent of axial regurgitation and accurately locate the repaired valve. In this case, when the contrast agent passed through the first pair of valves in the femoral vein, the concentration and velocity did not change significantly, causing the valve to become heavily stained and making it impossible to determine the location of the valve sinuses. The reason for this phenomenon may be that the structure of the degenerated tricuspid valve differs from that of the bicuspid valve; the three leaflets are difficult to mate and the intervalvular space is larger, resulting in inferior anti-regurgitation properties compared to the bicuspid valve.

[0042] The surgical plan in this case was based on the unique morphological characteristics of the tricuspid valve. The procedure involved removing the short right leaflet and reconstructing the attachment edges of the left and posterior leaflets to achieve the transformation from a tricuspid to a bicuspid valve. Researchers have found through cadaveric autopsies that tricuspid valves typically rely on the dominant role of two leaflets during closure, with the third leaflet playing a supporting role. Furthermore, the free edge of a tricuspid valve is not always tightly closed, leaving an "exposed area" between the valve lumens, leading to blood reflux. Instead of preserving the tricuspid structure, we transformed the tricuspid valve into a bicuspid valve, which better suits the physiological structure of most people and provides superior anti-reflux performance.

[0043] The exemplary embodiments of this disclosure described in detail above are merely illustrative and not restrictive. Those skilled in the art will understand that various modifications and combinations can be made to these embodiments or their features without departing from the principles and spirit of this disclosure, and such modifications should fall within the scope of this disclosure.

Claims

1. A system for shaping a femoral vein tricuspid valve, characterized in that, include: The surgical field image acquisition module is configured to acquire surgical field images in which the first pair of venous valves have been exposed during the femoral vein valve repair surgery; The leaflet morphology judgment module is configured to analyze the number of leaflets and at least one morphological feature of the first pair of valves based on the surgical field image. When the number of leaflets is 3, a target leaflet is selected from the 3 leaflets based on the at least one leaflet morphological feature. The target leaflet is a smaller or significantly underdeveloped leaflet determined based on a comprehensive judgment of size and development degree. The ablation module is configured to ablate the target leaflet.

2. The angioplasty system for the femoral vein tricuspid valve according to claim 1, characterized in that, The comprehensive judgment includes: extracting the edges of the three leaflets respectively to obtain the size of the three leaflets, comparing the sizes of the three leaflets, and selecting the leaflet with the smallest size as the target leaflet.

3. The angioplasty system for the femoral vein tricuspid valve according to claim 1, characterized in that, The comprehensive judgment includes: extracting the edges of the three leaflets respectively to obtain the size of the three leaflets, and judging whether the size of the first leaflet is smaller than the average size of the second and third leaflets. If so, the first leaflet is taken as the target leaflet.

4. The angioplasty system for the femoral vein tricuspid valve according to claim 1, characterized in that, The assessment of the degree of development is based on the shape and size of the valve leaflets, the structure of the corresponding sinuses, or a combination thereof.

5. The angioplasty system for the femoral vein tricuspid valve according to any one of claims 1-4, characterized in that, The system also includes: The remaining leaflet reconstruction module is configured to reconstruct the attachment edges of the remaining two leaflets under direct intracavitary visualization; the attachment lines of the remaining two leaflets are adjusted by bilateral suspension so that the height and mating surface of the two leaflets meet the requirements of symmetry and stability. The suturing module is configured to control the suturing of venous incisions.

6. The angioplasty system for the femoral vein tricuspid valve according to claim 1, characterized in that, The reconstruction was performed using Prolene lines.

7. The angioplasty system for the femoral vein tricuspid valve according to any one of claims 1-4, characterized in that, The system also includes an installation navigation system, the installation navigation system comprising: The step-by-step guidance module is configured to provide real-time prompts for the sequence of surgical steps; The operation monitoring unit is configured to acquire surgical field image data via an image monitoring device; The early warning module is configured to generate early warning information and trigger audible and visual alerts in response to the triggering of early warning conditions; The processing module is configured as follows: Based on the surgical field image data, the instrument positions and valve characteristics within the surgical field are tracked and acquired. Based on the instrument location and valve characteristics, the surgical steps are updated and displayed to the user using the step guidance module.

8. A device for forming a femoral vein tricuspid valve, characterized in that, The device includes: one or more processors and a memory; the memory is used to store one or more computer programs; when the one or more computer programs are executed by the one or more processors, the following steps are performed: S101, Obtain surgical field images showing the first pair of venous valves during femoral vein valve repair surgery; S102, based on the surgical field image analysis, the number of leaflets and at least one morphological feature of the first pair of valves are analyzed. When the number of leaflets is 3, a target leaflet is selected from the 3 leaflets based on the at least one leaflet morphological feature. The target leaflet is a smaller or significantly underdeveloped leaflet determined based on a comprehensive judgment of size and development degree. S103, the target leaflet is removed.

9. The device for forming a femoral vein tricuspid valve according to claim 8, characterized in that, The steps also include: Under direct intracavitary visualization, the attachment edges of the remaining two leaflets are reconstructed; the attachment lines of the remaining two leaflets are adjusted by bilateral suspension to ensure that the height and occlusal surface of the two leaflets meet the requirements of symmetry and stability; the venous incision is sutured.

10. The device for forming a femoral vein tricuspid valve according to claim 8, characterized in that, The device includes: a scalpel, scissors, hemostatic forceps, suture needles, and suture thread.

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