A universal heart valve disease interventional device stabilizer

Abstract

The present invention provides a universal heart valve disease interventional instrument stabilizer, comprising a base, a planar rotating device, a robotic arm, a slide rail, a support platform, a clamp, and a universally rotatable joint, wherein the base is connected to the planar rotating device, the planar rotating device is connected to the robotic arm, the robotic arm extends away from the planar rotating device and can bend and maintain the shape, the top of the robotic arm is connected to the slide rail via one of the joints, a support platform is slidingly provided in the slide rail, and the support platform is connected to the clamp via another of the joints. The universal heart valve disease interventional instrument stabilizer of the present invention can assist the operator in stabilizing the interventional instrument during interventional surgery, especially in transcatheter tricuspid valve replacement surgery using Lux‑Valve, which can ensure that the direction of movement of the instrument is consistent with the direction of bending of the front end of the catheter, thereby helping the operator to control the interventional instrument, complete the delivery and release of the artificial valve, and improve surgical efficiency.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a universal heart valve disease interventional device stabilizer. Background Art

[0002] The heart valve is a one-way "valve" structure between the atria and ventricles, ensuring that blood flows from the atria to the ventricles. The normal valve structure consists of two parts: the valve leaflets and the valve ring. When the physiological structure and / or function of the valve ring or valve leaflets are damaged due to factors such as aging and disease, valvular disease will occur, which is usually of the type of valve stenosis / regurgitation. Once valve stenosis and / or regurgitation occurs, it will affect normal blood flow, and abnormal hemodynamic changes will increase the burden on the heart, and will eventually lead to heart failure. Heart valve disease seriously affects the health and quality of life of patients, so it needs to be given sufficient attention.

[0003] With the aging population, valvular heart disease has become a significant burden in my country. While traditional open-chest surgical valve repair or replacement remains the standard treatment for valvular heart disease, the complex disease spectrum in my country often makes it difficult for elderly patients and those identified as high-risk by surgical assessment to tolerate surgery. In recent years, transcatheter interventional therapy has rapidly advanced both domestically and internationally, becoming a key treatment option for patients at high surgical risk. While transcatheter interventional therapy for the mitral, aortic, and pulmonary valves is now widely available, treatment for tricuspid valve disease remains in its early stages. The large diameter of the tricuspid valve, its anatomical location adjacent to the right coronary artery, and the lack of calcification within the valve and annulus significantly limit the development of transcatheter interventional therapy for tricuspid valve disease. The current Tricuspid Valve Registry has shown that patients selected for high surgical risk who received NovelGate technology experienced a significant increase in cardiac output within a short period of 3-6 months. In my country, preliminary clinical trials using the Lux-Valve transcatheter prosthetic tricuspid valve have demonstrated safety and effectiveness, with postoperative ultrasound demonstrating good valve position and no regurgitation. Because the Lux-Valve prosthetic valve is secured to the anterior tricuspid valve and ventricular septum via hooks and anchors, respectively, it significantly reduces the risk of postoperative atrioventricular block compared to traditional prosthetic valves, significantly reducing the risk of postoperative atrioventricular block. Therefore, the Lux-Valve is expected to become an important treatment for tricuspid regurgitation in the future.

[0004] Existing transcatheter interventional devices are all handheld, requiring the surgeon to adjust their handling depending on the surgical approach, patient positioning, and disease severity. Handheld devices can affect the surgeon's precision and increase surgical risk. Especially during transcatheter tricuspid valve replacement, because the pericardium, heart, and right atrium are exposed through a mid-axillary intercostal incision, the right atrial approach is not aligned with the level of the tricuspid annulus. Therefore, the distal end of the Lux-Valve delivery device is designed with an adjustable bending mechanism. Because the distal end of the delivery catheter forms a certain angle with the delivery system, the surgeon's handheld device movement is not aligned with the direction of the catheter's distal end within the atrium. While this design aligns with human anatomy, when the surgeon needs to advance or retract the distal end of the catheter at the level of the annulus to determine the optimal valve release position, handheld operation often presents difficulties in maintaining control, necessitating the assistance of one or two assistants. If the surgeon blindly advances the catheter tip directly in the direction of the handheld instrument, the valve may become loosely fixed, leading to serious complications such as post-valvular displacement, paravalvular leakage, cardiac rupture and perforation, and even leading to surgical failure. This drawback inconveniences the surgeon and limits the widespread application of this technology. Summary of the Invention

[0005] In order to solve the above problems, the present invention provides a universal heart valve disease interventional device stabilizer, which is a stabilizer for interventional devices in which the front end of the delivery catheter is at an angle to the delivery system.

[0006] The technical solution is as follows:

[0007] A universal heart valve disease interventional instrument stabilizer includes a base, a planar rotating device, a robotic arm, a slide rail, a support platform, a clamp and a universally rotatable joint. The base is connected to the planar rotating device, the planar rotating device is connected to the robotic arm, the robotic arm extends away from the planar rotating device and can bend and maintain the shape. The top of the robotic arm is connected to the slide rail through one of the joints, and a support platform is slidingly provided in the slide rail. The support platform is connected to the clamp through another joint.

[0008] Interventional therapy is a treatment method that uses an interventional instrument delivery device to deliver an artificial stent / valve to the diseased site of the human body, and then withdraws the delivery device so that the artificial stent / valve remains at the diseased site of the human body to replace the diseased human tissue and organs. The stabilizer of the present invention is an auxiliary interventional instrument delivery device used in the treatment of various heart valve diseases. Its specific use steps are as follows: first, place the stabilizer at an appropriate position on the operating table; second, remove the support platform with the clamp from the slide rail, adjust the angle of the clamp, and place the interventional instrument delivery device into the clamp; third, adjust the position and height of the remaining parts of the stabilizer, and adjust the height of the slide rail to a position suitable for loading the support platform; fourth, load the support platform onto the slide rail and continue the surgical operation. During the operation, adjust the position of the clamp on the slide rail, and slowly release the artificial stent / valve after the position is satisfactory. The stabilizer of the present invention can assist the operator in stabilizing the interventional instrument during interventional surgery and avoid mistakes caused by the operator's hand-held operation. In particular, in transcatheter tricuspid valve replacement using the Lux-Valve, the distal end of the Lux-Valve delivery device features an adjustable bending structure, forming a specific angle with the end of the delivery catheter held by the clamp. The stabilizer of the present invention aligns the movement of the clamp's gripping end with the bending direction of the distal end, thereby assisting the surgeon in manipulating the interventional instrument, completing the delivery and release of the prosthetic tricuspid valve and improving surgical efficiency and accuracy.

[0009] Furthermore, the slide rail includes a guide rail frame and a threaded guide rail on the guide rail frame. The top end of the robotic arm is connected to the bottom of one end of the guide rail frame via a joint. The guide rail frame has a closed end at one end and an open end at the other end. The threaded guide rail is installed between the closed end and the open end. The support platform is provided with a threaded guide groove for passing through the threaded guide rail. The threaded guide rail and the threaded guide groove match each other to enable the support platform to move closer to and away from the threaded guide rail when one end of the threaded guide rail rotates. The present invention provides a specific slide rail structure, wherein the slide rail is hollow in design, one end is connected to the joint, and the other end is a distal end. The threaded guide rail is adapted to the shape of the threaded guide groove of the support platform, and the support platform can be moved back and forth on the threaded guide rail by rotating the threaded guide rail. The purpose of the open design at the other end of the guide rail frame is to: during surgery, the support platform must first be removed from the slide rail, the angle of the clamping jaws must be adjusted according to the bending angle of the interventional instrument delivery device, and the clamping jaws and support platform connected to the interventional instrument delivery device are loaded onto the slide rail before subsequent operations. Openable design for easy removal and installation.

[0010] Furthermore, two cylindrical guide rails are installed between the closed end and the openable end. These cylindrical guide rails are arranged on either side of the threaded guide rail. The support platform is provided with circular grooves that pass through and mate with the cylindrical guide rails. The support platform moves back and forth on the threaded guide rails and the two cylindrical guide rails. The cylindrical guide rails on either side primarily prevent the support platform from drifting during movement on the threaded guide rails and define the direction of the support platform's movement, ensuring a more accurate movement path and reducing errors.

[0011] Furthermore, one end of the threaded guide rail is connected to a manual knob. By rotating the manual knob, the support platform can move back and forth on the threaded guide rail and the cylindrical guide rail. The setting of the manual knob makes the use of the stabilizer more convenient.

[0012] Furthermore, the guide rail frame is opened and closed at one end by a rotating device. In the open state, it is used to unload or load the clamping claws and the support platform. In the closed state, the support platform moves back and forth on the threaded guide rail and the two cylindrical guide rails.

[0013] The clamping jaws further comprise a clamping base and two opposing left and right clamping jaws. A spring is disposed within the clamping base, securing the left and right clamping jaws to the clamping base via the springs. The support platform is connected to the clamping base via the joint. Both ends of the clamping jaws feature pop-up structures to accommodate instruments of varying diameters, and a spring is embedded within the jaws to adjust tension during opening.

[0014] Furthermore, the universally rotatable joint includes a spherical joint, a locking sleeve, a screw locking device and a connecting ring. The spherical joint includes a sphere and a connecting shaft connected to the sphere. The locking sleeve forms a left locking part and a right locking part. The outer surfaces of the left locking part and the right locking part are provided with a screw locking device. When locking the sphere, by operating the screw locking device, the left locking part and the right locking part are brought closer to each other and tightened inward, hugging and sticking to the surface above or below the horizontal large circle of the sphere. The connecting shaft and the connecting ring are engaged with the other end of the locking sleeve that hugs the sphere. The top of the robotic arm is connected to the locking sleeve of one of the joints, the connecting ring of the joint is connected to the slide rail, the support platform is connected to the connecting ring of another joint, and the locking sleeve of the joint is connected to the clamp mounting seat. The present invention provides a specific joint structure that realizes universal rotation through the sphere and locks the sphere through the screw locking device and the locking sleeve. One joint is set between the robotic arm and the slide rail to adjust the inclination angle of the slide rail. The other joint is set between the support platform and the clamp to adjust the angle of the clamp. After adjusting each angle, operate the screw locking device to lock the state of the ball at that angle.

[0015] Furthermore, the robotic arm includes a first joint axis, a main robotic arm, a second joint axis, an auxiliary robotic arm, and a third joint axis, which are connected in sequence. The first joint axis is connected to a planar rotation device, and the third joint axis is connected to a locking sleeve. The first joint axis performs a "shoulder rotation" movement to initially adjust the overall height of the stabilizer. The second joint axis performs an "elbow rotation" movement to further adjust the stabilizer's height. The third joint axis performs a "pitch" movement to fine-tune the stabilizer's height and orientation.

[0016] Furthermore, the base is connected to a base fixing device comprising two outer and inner plywood plates. The two outer plywood plates are positioned opposite each other on one side of the base. Each outer plywood plate is provided with a fastening screw that connects to the inner plywood plates and adjusts the tightness of the inner plywood plates. A hollow portion is formed between the inner plywood plates, through which the railings of the operating table can be passed. The depth of the fastening screws in the hollow portion can be adjusted to accommodate the varying diameters of operating tables of different models and specifications.

[0017] Furthermore, angle scale marks are provided on the plane rotating shaft device, the first joint shaft, the second joint shaft, the third joint shaft, and the connecting ring connected to the support platform. The angle scale marks facilitate selection of a suitable angle for fixation, thereby enhancing the accuracy of the operation.

[0018] Compared with the existing technology, the beneficial effect of the present invention is that the universal heart valve disease interventional device stabilizer of the present invention can assist the operator in stabilizing the interventional device during interventional surgery, especially in the application of Lux-Valve for transcatheter tricuspid valve replacement, it can ensure that the movement direction of the device is consistent with the bending direction of the front end of the catheter, thereby helping the operator to control the interventional device, complete the delivery and release of the artificial valve, and improve the efficiency and accuracy of the operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 This is a schematic diagram of the structure of the universal heart valve disease interventional device stabilizer of the present invention. Figure 1 .

[0020] Figure 2 This is a schematic diagram of the structure of the universal heart valve disease interventional device stabilizer of the present invention. Figure 2 .

[0021] Figure 3 This is a schematic diagram of the structure of the universal heart valve disease interventional device stabilizer of the present invention. Figure 3 .

[0022] Figure 4 Schematic diagram of the exploded structure of the slide rail and the gripper platform that moves on it.

[0023] Figure 5 Schematic diagram of the decomposed structure of the joint between the robotic arm and the slide rail.

[0024] Figure 6 Schematic diagram of the exploded structure of the movable device on the slide rail.

[0025] Figure 7 Schematic diagram of the exploded structure of the base fixing device.

[0026] Figure 8 Release process for Lux valve.

[0027] The figure includes a base 1, a plane rotation device 2, a robotic arm 3, a first joint axis 31, a main robotic arm 32, a second joint axis 33, an auxiliary robotic arm 34, a third joint axis 35, a robotic arm mounting seat 36, a slide rail 4, a guide rail frame 41, a threaded guide rail 42, a cylindrical guide rail 43, a manual knob 44, a rotating device 45, a supporting platform 5, a threaded guide groove 51, a circular groove 52, a clamping jaw 6, a left clamping jaw 61, a right clamping jaw 62, a clamping jaw mounting seat 63, a spring 64, a joint 7, a spherical joint 71, a sphere 711, a connecting shaft, a locking sleeve 72, a left locking part 721, a right locking part 722, a screw locking device 73, a connecting ring 74, a transition connector 8, a base fixing device 9, an outer splint 91, an inner splint 92, and a fastening screw 93. DETAILED DESCRIPTION

[0028] The following are specific embodiments of the present invention and the accompanying drawings to further describe the technical solutions of the present invention, but the present invention is not limited to these embodiments.

[0029] like Figures 1 to 3 As shown, a universal heart valve disease interventional instrument stabilizer includes a base 1, a plane rotating device 2, a robotic arm 3, a slide rail 4, a support platform 5, a clamp 6 and a universally rotatable joint 7. The base 1 is connected to the plane rotating device 2, the plane rotating device 2 is connected to the robotic arm 3, the robotic arm 3 extends away from the plane rotating device 2, can bend and maintain the shape, the top of the robotic arm 3 is connected to the slide rail 4 through one of the joints 7, a support platform 5 is slidingly provided in the slide rail 4, and the support platform 5 is connected to the clamp 6 through another joint 7.

[0030] Interventional therapy is a treatment method that uses an interventional device delivery device to deliver an artificial stent / valve to the diseased area of ​​the human body, and then withdraws the delivery device to allow the artificial stent / valve to remain at the diseased area of ​​the human body, replacing the diseased human tissue and organs. The stabilizer of the present invention is an auxiliary interventional device delivery device used to treat various heart valve diseases. Its specific usage steps are as follows: First, place the stabilizer at an appropriate position on the operating table; second, remove the support platform 5 with the clamp 6 from the slide rail 4, adjust the angle of the clamp 6, and place the interventional device delivery device into the clamp 6; third, adjust the position and height of the remaining parts of the stabilizer and adjust the height of the slide rail 4 to a position suitable for loading the support platform 5; fourth, load the support platform 5 onto the slide rail 4 and continue the surgical operation. During the operation, adjust the position of the clamp 6 on the slide rail 4, and slowly release the artificial stent / valve when the position is satisfactory. The stabilizer of the present invention can assist the operator in stabilizing the interventional device during interventional surgery and avoid errors caused by the operator's hand-held operation. In particular, during transcatheter tricuspid valve replacement surgery using the Lux-Valve, the distal end of the Lux-Valve delivery device features an adjustable bending structure, forming a specific angle between the distal end of the delivery catheter and the end held by the clamp. The stabilizer of the present invention aligns the movement of the clamp (6) holding the catheter end with the bending direction of the distal end, thereby assisting the surgeon in manipulating the interventional device, completing the delivery and release of the prosthetic tricuspid valve and improving surgical efficiency and accuracy.

[0031] Combine Figure 4 The slide rail 4 includes a guide rail frame 41 and a threaded guide rail 42 and two cylindrical guide rails 43 on the guide rail frame 41. One end of the guide rail frame 41 is a closed end, and the other end 42 is an open end. The threaded guide rail 42 and the two cylindrical guide rails 43 are arranged between the closed end and the open end, and the cylindrical guide rails 43 are separated and arranged on both sides of the threaded guide rail 42. The support platform 5 is provided with a threaded guide groove 51 for passing through the threaded guide rail 42 and a circular groove 52 for passing through the cylindrical guide rail 43. The threaded guide rail 42 and the threaded guide groove 51 match each other to realize that when one end of the threaded guide rail 42 rotates, the support platform 5 on the threaded guide rail 42 moves closer to and away from the end. The cylindrical guide rail 43 and the circular groove 52 match each other to avoid the deviation of the support platform 5 on the threaded guide rail 42, limit the direction of movement of the support platform 5, make the movement route more accurate, and reduce errors. The purpose of the openable design at the other end of the guide rail frame 42 is to facilitate the removal and installation of the guide rail frame 41. During surgery, the support platform 5 must be removed from the slide rail 4, the angle of the clamping jaws 6 adjusted to the bending angle of the interventional device delivery device, and the clamping jaws 6 and support platform 5, already connected to the interventional device delivery device, must be loaded onto the slide rail 4 before proceeding. Specifically, the openable end of the guide rail frame 41 is opened and closed via a rotating mechanism 45.

[0032] Preferably, one end of the threaded guide rail 42 is connected to a manual knob 44. By rotating the manual knob 44, the support platform 5 can move back and forth on the threaded guide rail 42 and the cylindrical guide rail 43. The provision of the manual knob 44 makes the use of the stabilizer more convenient.

[0033] Figures 1 to 3 Show Figure 4 Schematic diagram of the assembled slide rail 4 and support platform 5. The slide rail 4 is hollow, with one end connected to the joint 7 and the other end being distal and open. The effect achieved is that by rotating the manual knob 44, the support platform 5 can move back and forth on the threaded guide rail 42 and cylindrical guide rail 43.

[0034] like Figures 1 to 3 As shown, the top of the robot arm 3 is connected to the bottom of one end of the guide rail frame 41 through a joint 7. Figure 5 The figure shows a schematic structural diagram of the joint 7. The universally rotatable joint 7 includes a spherical joint 71, a locking sleeve 72, a screw locking device 73, and a connecting ring 74. The spherical joint 71 includes a sphere 711 and a connecting shaft 712 connected to the sphere 711. The locking sleeve 72 forms a left locking portion 721 and a right locking portion 722. The outer surfaces of the left and right locking portions 721 and 722 are provided with screw locking devices 73. When locking the sphere 711, the screw locking devices 73 are operated to move the left and right locking portions 721 and 722 closer together and tighten inward, hugging and adhering to the surface below the horizontal large circle of the sphere 711. The connecting shaft 712 and the connecting ring 74 engage with the surface above the horizontal large circle of the sphere 711, that is, the locking sleeve 72 hugs the other end of the sphere 711. During the operation of the stabilizer of the present invention, the ball 711 is used to realize universal free rotation. After the angle is adjusted, the screw locking device 73 is operated to lock the state of the ball 711 at the angle.

[0035] like Figure 6 As shown, the clamping jaw 6 includes a clamping jaw mounting base 63 and a left clamping jaw 61 and a right clamping jaw 62 disposed opposite each other. A spring 64 is disposed within the clamping jaw mounting base 63. The left clamping jaw 61 and the right clamping jaw 62 are respectively fixed to the two sides of the clamping jaw mounting base 62 by the spring 64. The ends of the clamping jaw 6 are pop-up structures to accommodate instruments of different diameters. The clamping jaw 6 has a built-in spring to adjust the tension when it is opened.

[0036] like Figure 7As shown, a transition piece 8 is provided on the support platform 5, and the transition piece 8 is connected to the clamping jaw mounting base 63 via the aforementioned joint 7. The left locking portion 721 and the right locking portion 722 are brought together and tightened inward, hugging and adhering to the surface above the horizontal large circle of the sphere 711. The connecting shaft 712 and the connecting ring 74 are engaged with the surface below the horizontal large circle of the sphere 711. Angle scale markings are provided on the connecting ring 74 at this position to facilitate selection of the appropriate angle of the clamping jaw 6 and enhance surgical accuracy.

[0037] like Figures 1 to 3 As shown, the robotic arm 3 includes a first joint axis 31, a main robotic arm 32, a second joint axis 33, an auxiliary robotic arm 34, and a third joint axis 35 connected in sequence. The first joint axis 31 is connected to the plane rotation device 2 through a robotic arm mounting base 36, and the third joint axis 35 is connected to the locking sleeve 72. The first joint axis 31 realizes the "shoulder rotation" movement to preliminarily adjust the overall height of the stabilizer. The second joint axis 33 realizes the "elbow rotation" movement to further adjust the height of the stabilizer. The third joint axis 35 realizes the "pitch" movement to finely adjust the height and orientation of the stabilizer. The plane rotation axis device 2, the first joint axis 31, the second joint axis 33, and the third joint axis 34 are all marked with angle scales, which facilitates the selection of a suitable angle for fixation and enhances the accuracy of the operation.

[0038] like Figure 7 As shown, the base 1 is connected to a base fixing device 9, which includes two outer plywood plates 91 and two inner plywood plates 92. The two outer plywood plates 91 are arranged on one side of the base, facing each other. Each outer plywood plate 91 is provided with a fastening screw 93. The fastening screw 93 connects to the inner plywood plates 92 and is used to adjust the clamping tightness of the inner plywood plates 92. A hollow portion is formed between the inner plywood plates 92, which is used to pass the railing of the operating table. By adjusting the depth of the fastening screw 93 in the hollow portion, it can accommodate the different diameters of different models and specifications of operating tables. Preferably, the cross-section of the inner plywood plates 92 is C-shaped. Since the cross-section of the railing of the operating table is mostly circular, the C-shaped cross-section of the inner plywood plates 92 facilitates clamping and fixing.

[0039] For the convenience of description, the direction close to the operator is defined as the proximal end, and the direction away from the operator is defined as the distal end. Taking this design as an example, the specific implementation method is introduced in combination with the use of Lux-Valve for artificial tricuspid valve replacement. During the implementation of this design, CT angiography and a 3D printed model of the patient's heart are first used to assist the surgeon in confirming the angle between the right atrial approach and the tricuspid valve annulus during the operation. Before or during the operation, the joystick of the interventional instrument is adjusted to bend the front end of the delivery sheath to a corresponding angle. The angle is as follows: Figure 8 The angle a shown in FIG. 30° is taken as an example in this embodiment, and the same applies hereinafter.

[0040] The first step is to fix the stabilizer to the appropriate position of the operating table through the base fixing device 9.

[0041] Step 2: "Adjust the Angle and Clamp the Instrument." Remove the support platform 5 and the components above it from the stabilizer. Rotate joint 7 to adjust the angle, aligning the angle mark on the connecting ring 74 with 30°. Adjust and tighten the screw lock 73 of joint 7. Open the sides of the clamping jaws 6 and adjust them to the position that secures the instrument.

[0042] The third step, "Adjusting Height and Preparing for Loading," involves adjusting the stabilizer's joint axes to ensure the stabilizer is positioned appropriately. Adjust the third joint axis 35 of the robotic arm 3 and its top joint 7 to ensure the slide rail 4's inclination matches the position of the instrument and the gripper. Tighten the screw lock 73 of joint 7. It's best to position the stabilizer's distal end directly toward the operating table, or position the main robotic arm 32 and auxiliary robotic arm 34 to the side of the surgeon's body to provide ample operating space.

[0043] The fourth step, “loading and preparing for debugging”, is to load the supporting platform 5 and the devices above it onto the slide rail 4.

[0044] Step 5, "Complete debugging, continue surgery" condition: tighten the screw 73 of the joint 7 at the bottom of the slide rail 4, and confirm with the help of ultrasound or angiography that the long axis direction of the slide rail 4 is consistent with the direction of the front end of the 30° bent catheter. Figure 8 If the directions are consistent, the surgery can continue; if not, the joints 7 and the remaining joint axes of the robotic arm 3 are readjusted until the directions and angles are satisfactory. The stabilizer of the present invention is now fixed, and the surgery and catheter delivery are ready.

[0045] Step 6. General surgical procedure: the patient is anesthetized by endotracheal intubation, esophageal ultrasound is placed, and extracorporeal circulation is ready. The surgical incision is planned to be a right anterior and lateral fourth intercostal incision (incision is about 5-8 cm). Double purse-string suture is performed on the right atrium. The delivery device is implanted through the right atrial incision. Under X-ray and ultrasound guidance, the surgeon moves the tip of the delivery catheter through the tricuspid valve orifice through the slide rail 4 of the stabilizer of the present invention, and locates the posterior valve ring of the tricuspid valve according to the positioning method. Under X-ray fluoroscopy, rotate the manual knob 44 on the slide rail 4 to adjust the position of the catheter. After the position is satisfactory, the artificial tricuspid valve is slowly released, the anterior leaflet clamp hooks the anterior valve ring, the anchoring device is parallel to the ventricular septum, the anchoring needle is perpendicular to the ventricular septum, and the anchoring needle is pushed to fix the anchor. The delivery device is withdrawn, the right atrium is hemostatic, and the tricuspid valve function is evaluated by ultrasound. Close the chest and return to the intensive care unit.

[0046] In summary, the universal heart valve disease interventional device stabilizer of the present invention can assist the operator in stabilizing the interventional device during interventional surgery, especially in transcatheter tricuspid valve replacement surgery using Lux-Valve, it can ensure that the direction of device movement is consistent with the direction of bending of the front end of the catheter, thereby helping the operator to control the interventional device, complete the delivery and release of the artificial valve, and improve surgical efficiency.

[0047] The specific embodiments described herein are merely illustrative of the spirit of the present invention. Persons skilled in the art may make various modifications, additions, or substitutions to the described specific embodiments without departing from the spirit of the present invention or exceeding the scope of the appended claims.

Claims

1. A universal heart valve disease interventional device stabilizer, characterized in that: The invention comprises a base (1), a plane rotating device (2), a robot arm (3), a slide rail (4), a support platform (5), a clamping claw (6) and a universally rotatable joint (7), wherein the base (1) is connected to the plane rotating device (2), the plane rotating device (2) is connected to the robot arm (3), the robot arm (3) extends away from the plane rotating device (2), can bend and maintain the shape, the top end of the robot arm (3) is connected to the slide rail (4) through one of the joints (7), a support platform (5) is slidably provided in the slide rail (4), and the support platform (5) is connected to the clamping claw (6) through another of the joints (7); a transition connector (8) is provided on the support platform (5), and the transition connector (8) is connected to the clamping claw mounting seat (63) through the joint (7); The slide rail (4) includes a guide rail frame (41) and a threaded guide rail (42) on the guide rail frame (41); the top end of the robot arm (3) is connected to the bottom of one end of the guide rail frame (41) through a joint (7); one end of the guide rail frame (41) is a closed end, and the other end is an openable end; the guide rail frame (41) realizes opening and closing of the openable end side through a rotating device (45); the threaded guide rail (42) is set between the closed end and the openable end; the support platform (5) is provided with a threaded guide groove (51) for passing through the threaded guide rail (42); the threaded guide rail (42) and the threaded guide groove (51) match each other to realize that when one end of the threaded guide rail (42) rotates, the support platform (5) approaches and moves away from the threaded guide rail (42) on the threaded guide rail (42); Two cylindrical guide rails (43) are also arranged between the closed end and the openable end, and the cylindrical guide rails (43) are separately arranged on both sides of the threaded guide rail (42). A circular groove (52) for passing through the cylindrical guide rail (43) and matching the cylindrical guide rail (43) is provided on the support platform (5); one end of the threaded guide rail (42) is connected to a manual knob (44); the robotic arm (3) includes a first joint shaft (31), a main robotic arm (32), a second joint shaft (33), an auxiliary robotic arm (34), and a third joint shaft (35) connected in sequence, the first joint shaft (31) is connected to the plane rotation device (2), and the third joint shaft (35) is connected to the locking sleeve (72); The base (1) is connected to a base fixing device (9), and the base fixing device (9) includes two outer plywood (91) and two inner plywood (92). The two outer plywood (91) are arranged on one side of the base (1) facing each other, and fastening screws (93) are respectively provided on the outer plywood (91). The fastening screws (93) are connected to the inner plywood (92) and are used to adjust the clamping tightness of the inner plywood (92); angle scale marks are provided on the plane rotating device (2), the first joint shaft (31), the second joint shaft (33), the third joint shaft (35) and the connecting ring (74) connected to the support platform (5).

2. The universal heart valve disease interventional device stabilizer according to claim 1, characterized in that: The clamping jaw (6) comprises a clamping jaw mounting seat (63) and a left clamping jaw (61) and a right clamping jaw (62) arranged opposite to each other. A spring (64) is arranged in the clamping jaw mounting seat (63). The left clamping jaw (61) and the right clamping jaw (62) are respectively fixed to both sides of the clamping jaw mounting seat (63) by the spring (64). The supporting platform (5) is connected to the clamping jaw mounting seat (63) via the joint (7).

3. The universal heart valve disease interventional device stabilizer according to claim 1 or 2, characterized in that: The universally rotatable joint (7) comprises a spherical joint (71), a locking sleeve (72), a screw locking device (73) and a connecting ring (74). The spherical joint (71) comprises a sphere (711) and a connecting shaft (712) connected to the sphere (711). The locking sleeve (72) forms a left locking portion (721) and a right locking portion (722). The outer surfaces of the left locking portion (721) and the right locking portion (722) are provided with a screw locking device (73). When the sphere (711) is locked, the left locking portion (721) is locked by operating the screw locking device (73). 721) and the right locking portion (722) are brought close to each other and tightened inward, hugging and sticking to the surface above or below the horizontal large circle of the sphere (711), the connecting shaft (712) and the connecting ring (74) are engaged with the other end of the locking sleeve (72) hugging the sphere (711), the top of the robot arm (3) is connected to the locking sleeve (72) of one of the joints (7), the connecting ring (74) of the joint (7) is connected to the slide rail (4), the support platform (5) is connected to the connecting ring (74) of another joint, and the locking sleeve (72) of the joint (7) is connected to the clamp mounting seat (63).

Images