A valve repair device, a valve repair system, and its working method

Abstract

This invention provides a valve repair device, a valve repair system, and its operating method. The lifting components are all rigid structures, with the proximal end of each lifting component rotatably connected to the distal end of a stop structure. The distal end of each lifting component is rotatably connected to the distal end of a drive rod, allowing the shape of the lifting components to change through axial movement of the drive rod. This enables the lifting components to lift, clamp, and release chordae tendineae within a 0°–360° range, reducing the number of product specifications and significantly increasing the flexibility and convenience of the surgeon's operation. Furthermore, during surgery, if the valve repair device gets caught on the chordae tendineae, the flexible structure allows for a larger angle and smaller diameter in the open state, making release easier.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a valve repair device, valve repair system and its working method belonging to the category of heart valves, which achieves valve repair through minimally invasive intervention. Background Technology

[0002] Heart valves (aortic, pulmonary, tricuspid, and mitral valves) play a crucial role in ensuring adequate forward blood flow through the cardiovascular system. These valves can be damaged due to congenital malformations, inflammatory processes, infections, diseases, etc., leading to reduced valve effectiveness. This damage can result in serious cardiovascular injury or death. Damaged heart valves can be repaired or replaced through open-heart surgery. However, open-heart surgery is highly invasive and can cause complications. Transcatheter vascular techniques allow for the introduction and implantation of prosthetic devices in a much less invasive manner than open-heart surgery. Valve repair devices are primarily used in transcatheter vascular techniques, which achieve edge-to-edge valve repair via a catheter, resulting in less trauma and faster recovery compared to traditional surgery.

[0003] Current edge-to-edge interventional repair devices are structurally complex or have functional defects. For example, the Mitraclip product. The two grippers of the Mitraclip product are connected as a single component, which limits the gripping angle when holding the valve leaflets. This can easily lead to poor gripping performance for different patient groups, and during implant positioning or retrieval, the implant can easily become entangled or stuck in related tissues (such as chordae tendineae). Another example is the Pascal product, which uses a flexible support structure, resulting in a long delivery length that is not conducive to vascular delivery. Its locking mechanism, relying on elasticity, has low reliability, and the leaflet clamping area is too large. Summary of the Invention

[0004] The purpose of this invention is to provide a valve repair device, a valve repair system, and a method for operating the same, which can have a good valve leaflet clamping effect, improve the ease of use of the product, reduce the number of product specifications, expand the product indications, and reduce the difficulty of surgical operation.

[0005] To address the aforementioned problems, this invention provides a valve repair device, comprising a stop structure, a drive rod, and a clamping and lifting structure. The drive rod is axially movable and passes through the stop structure, and the proximal end of the drive rod is detachably connected to the distal end of the delivery catheter. The stop structure is located at the proximal end of the drive rod and is used to switch the axial movement state and locking state of the drive rod.

[0006] The clamping and lifting structure includes a clamping component and a lifting component. The lifting component is a rigid structure. The clamping component is located at the proximal end of the lifting component and is used to cooperate with the lifting component to clamp the leaflets. The proximal end of the lifting component is rotatably connected to the distal end of the stop structure. The distal end of the lifting component is rotatably connected to the distal end of the drive rod and is used to change the shape of the lifting component through the axial movement of the drive rod, so that the lifting component can achieve leaflet lifting, leaflet clamping, and chordae tendineae release within a range of 0° to 360°.

[0007] Optionally, the clamping component includes two grippers, and the lifting component includes two first connecting rods and two second connecting rods. One end of each first connecting rod and one end of each second connecting rod are rotatably connected, and the other end of each first connecting rod is rotatably connected to the distal end of the stop structure. The other end of each second connecting rod is rotatably connected to the distal end of the drive rod. Each gripper is respectively disposed on one of the first connecting rods. The gripper cooperates with the first connecting rod to clamp the leaflets. The shape of the first connecting rod and the second connecting rod changes due to the axial movement of the drive rod.

[0008] Furthermore, the included angle between the two first connecting rods is 0° to 360°.

[0009] Furthermore, when the included angle between the two first connecting rods is 0°~20°, the clamping and lifting structure is used to close the petals;

[0010] When the included angle between the two first connecting rods is 90° to 180°, the lifting component is used to capture the leaflets; and

[0011] When the included angle between the two first connecting rods is 270°~360°, the lifting component is used for release after the tendinous cords have been wrapped.

[0012] Furthermore, when the included angle between the two first connecting rods is 0° to 360°, the clamping component clamps the leaflet.

[0013] Furthermore, when the included angle between the two first connecting rods is 90° to 180°, the clamping component clamps the leaflet.

[0014] Furthermore, the two first connecting rods and the two second connecting rods are symmetrically arranged on both sides of the drive rod.

[0015] Furthermore, the two first connecting rods, the two grippers, and the two second connecting rods are symmetrically arranged on both sides of the drive rod.

[0016] Furthermore, both the first and second connecting rods are made of rigid materials, while the grippers are made of elastic or hyperelastic materials.

[0017] Furthermore, the gripper includes a fixed part and a movable part, the fixed part and the movable part are connected and have a negative included angle, the movable part can rotate around the fixed part, and when the included angle between the fixed part and the movable part is greater than or equal to 0°, a rebound force is generated between the fixed part and the movable part, and the rebound force increases as the included angle increases.

[0018] Furthermore, one end of the fixed part and one end of the movable part are connected to form a connecting end. The fixed part has a first free end disposed opposite to the connecting end, and the movable part has a second free end disposed opposite to the connecting end. The fixed part is fixed on the first connecting rod, and the connecting end is disposed close to the driving rod. The movable part is fitted on the side of the first connecting rod close to the proximal end, and the included angle between the fixed part and the movable part is 0°. There is a rebound force between the movable part and the fixed part.

[0019] Furthermore, the second free end has a through hole for connecting the distal end of the pull wire. When the proximal end of the pull wire provides a pulling force, the second free end moves away from the first free end with the pulling force and rotates. As the movable part rotates, the spring force between the movable part and the fixed part increases.

[0020] On the other hand, the present invention provides a valve repair system, including the valve repair device and a delivery device. The delivery device includes a delivery catheter, the distal end of which is detachably connected to the proximal end of a drive rod. The delivery catheter and the drive rod are axially movable through a stop structure. When the delivery catheter drives the drive rod to move axially, the shape of the lifting component changes to achieve chordae tendineae release, leaflet lifting, clamping, and closure.

[0021] Furthermore, the present invention provides a method for operating a valve repair system, comprising the aforementioned valve repair system, including the following steps:

[0022] When the drive rod moves axially such that the included angle θ between the two first connecting rods is 0° to 20°, the valve repair device is delivered.

[0023] When the drive rod moves axially, and the included angle θ between the two first connecting rods is 270°~360°, the lifting component is released from the wrapped tendon.

[0024] The drive rod moves axially and applies a pulling force to both grippers simultaneously, causing the second free end to approach the drive rod. When the angle θ between the two first connecting rods is 90°~180°, the lifting component captures the leaflet and withdraws the pulling force of the two grippers, so that each gripper simultaneously holds the leaflet with one of the first connecting rods.

[0025] When the drive rod moves axially, the leaflets close when the included angle θ between the two first connecting rods is 0° to 20°, thus achieving edge-to-edge technology.

[0026] Compared with the prior art, the present invention has the following technical effects:

[0027] This invention provides a valve repair device, a valve repair system, and its operating method. The lifting component is a rigid structure, with its proximal end rotatably connected to the distal end of a stop structure. The distal end of the lifting component is rotatably connected to the distal end of a drive rod. The axial movement of the drive rod causes the shape of the lifting component to change, enabling it to lift, clamp, and release the chordae tendineae within a 0°~360° range. This significantly increases the flexibility and convenience of the surgeon's operation. Furthermore, during surgery, if the valve repair device gets caught on the chordae tendineae, the flexible structure allows for a larger angle and smaller diameter in the open state, facilitating easier release.

[0028] Furthermore, the second free end has a through hole for connecting the distal end of the pull wire. When the proximal end of the pull wire provides traction, the second free end moves away from the first free end and rotates as the traction force moves. As the movable part rotates, the elastic force between the movable part and the fixed part increases, further increasing the flexibility and convenience of the doctor's operation.

[0029] Furthermore, the two first connecting rods and the two second connecting rods are symmetrically arranged on both sides of the drive rod, so that the entire structure has fewer types of parts and fewer processes due to the completely symmetrical design, which is more conducive to mass production. Attached Figure Description

[0030] Figure 1a This is a schematic diagram of a valve repair system according to an embodiment of the present invention;

[0031] Figure 1b for Figure 1a Enlarged view of region A in the middle;

[0032] Figures 2a-2b This is a schematic diagram of the valve repair device according to an embodiment of the present invention;

[0033] Figure 3 This is a schematic diagram of the structure of the first connecting rod according to an embodiment of the present invention;

[0034] Figure 4 This is a schematic diagram of the structure of the second connecting rod according to an embodiment of the present invention;

[0035] Figure 5 This is a schematic diagram of the gripper structure according to an embodiment of the present invention;

[0036] Figures 6a-6c This is a schematic diagram of the lifting component in different states according to an embodiment of the present invention.

[0037] Explanation of reference numerals in the attached figures:

[0038] 1-Valve repair device; 2-Catheter assembly; 21-Delivery catheter; 22-Inner sheath catheter; 23-Outer sheath catheter; 3-Delivery handle; 31-First handle; 32-Second handle; 33-Third handle; 4-Leaflet;

[0039] 100-Drive lever;

[0040] 200 - Stop structure; 210 - Drive slider; 211 - First sidewall; 212 - Second sidewall; 220 - Locking element;

[0041] 300-Gripper component; 310-Gripper; 310a-Connecting end; 311-Fixing part; 311a-First free end; 312-Modible part; 312b-Second free end; 313-Second opening; 314-Opening; 315-Through hole; 316-Barb;

[0042] 400 - Lifting component; 410 - First connecting rod; 410a - First end; 410b - Second end; 411 - First bottom wall; 412 - First connecting wall; 413 - First notch; 414 - First opening; 415 - First hinge hole; 420 - Second connecting rod; 420a - First end; 420b - Second end; 421 - Second bottom wall; 422 - Second connecting wall; 423 - Second notch; 424 - Third notch; 425 - First stitching hole; 426 - Second hinge hole; 427 - Notch; 428 - Second stitching hole. Detailed Implementation

[0043] The core idea of ​​this invention is to provide a valve repair device, including a stop structure, a drive rod, and a clamping and lifting structure. The drive rod is axially movable and passes through the stop structure, and the proximal end of the drive rod is detachably connected to the distal end of the delivery catheter. The stop structure is located at the proximal end of the drive rod and is used to switch the axial movement state and locking state of the drive rod.

[0044] The clamping and lifting structure includes a clamping component and a lifting component. The lifting component is a rigid structure. The clamping component is located at the proximal end of the lifting component and is used to cooperate with the lifting component to clamp the leaflets. The proximal end of the lifting component is rotatably connected to the distal end of the stop structure. The distal end of the lifting component is rotatably connected to the distal end of the drive rod and is used to change the shape of the lifting component through the axial movement of the drive rod, so that the lifting component can achieve leaflet lifting, leaflet clamping, and chordae tendineae release within a range of 0° to 360°.

[0045] On the other hand, the present invention also provides a valve repair system, including the valve repair device and a delivery device. The delivery device includes a delivery catheter, the distal end of which is detachably connected to the proximal end of a drive rod. The delivery catheter and the drive rod are axially movable through a stop structure. When the delivery catheter drives the drive rod to move axially, the shape of the lifting component changes to achieve chordae tendineae release, leaflet lifting, clamping, and closure.

[0046] Furthermore, the present invention also provides a method for operating a valve repair system, comprising the aforementioned valve repair system, the method comprising the following steps:

[0047] When the drive rod moves axially such that the included angle θ between the two first connecting rods is 0° to 20°, the valve repair device is delivered.

[0048] When the drive rod moves axially, and the included angle θ between the two first connecting rods is 270°~360°, the lifting component is released from the wrapped tendon.

[0049] The drive rod moves axially and applies a pulling force to both grippers simultaneously, causing the second free end to approach the drive rod. When the angle θ between the two first connecting rods is 90°~180°, the lifting component captures the leaflet and withdraws the pulling force of the two grippers, so that each gripper simultaneously holds the leaflet with one of the first connecting rods.

[0050] When the drive rod moves axially, the leaflets close when the included angle θ between the two first connecting rods is 0° to 20°, thus achieving edge-to-edge technology.

[0051] The following will provide a more detailed description of a valve repair device, valve repair system, and its working method according to the present invention. The invention will now be described in more detail with reference to the accompanying drawings, which illustrate preferred embodiments of the invention. It should be understood that those skilled in the art can modify the invention described herein while still achieving its advantageous effects. Therefore, the following description should be understood as being of general knowledge to those skilled in the art and is not intended to limit the invention.

[0052] For clarity, not all features of the actual embodiments are described. In the following description, well-known functions and structures are not detailed in detail, as they would obscure the invention with unnecessary detail. It should be understood that in the development of any actual embodiment, numerous implementation details must be made to achieve the developer's specific objectives, such as changes from one embodiment to another according to limitations related to the system or business. Furthermore, it should be understood that such development work may be complex and time-consuming, but is merely routine work for those skilled in the art.

[0053] To make the objectives and features of the present invention more apparent and understandable, the specific embodiments of the present invention will be further described below with reference to the accompanying drawings. It should be noted that the drawings are all in a very simplified form and use non-precise ratios, and are only used to facilitate and clearly illustrate the objectives of the embodiments of the present invention. In this document, the term "or" is generally used to include the meaning of "and / or" unless otherwise expressly stated. The terms "inner," "outer," and similar expressions used herein are for illustrative purposes only and do not represent the only possible embodiments. In this document, the terms "distal" and "proximal" refer to the relative orientation, position, or direction of elements or actions relative to each other from the perspective of a physician using the medical device. Although "distal" and "proximal" are not restrictive, "proximal" generally refers to the end of the medical device closer to the operator during normal operation, and "distal" generally refers to the end closer to the patient's heart.

[0054] Figure 1a This is a schematic diagram of the structure of a valve repair system provided in this embodiment. Figure 1b for Figure 1a An enlarged view of region A in the diagram. (See diagram below.) Figures 1a-1b As shown, this embodiment provides a valve repair system, including a delivery device and a valve repair device, wherein the valve repair device is detachably connected to the distal end of the delivery device.

[0055] The delivery device includes a delivery handle 3 and a catheter assembly 2. The catheter assembly 2 includes an outer sheath catheter 23, an inner sheath catheter 22 and a delivery catheter 21, which are sequentially connected from the outside to the inside. The distal end of the inner sheath catheter 22 extends beyond the distal end of the outer sheath catheter 23, and the distal end of the delivery catheter 21 extends beyond the distal end of the inner sheath catheter 22.

[0056] The delivery handle 3 includes a first handle 31, a second handle 32, and a third handle 33 arranged sequentially from proximal to distal. The first handle 31 is connected to the proximal end of the delivery catheter 21 and is used to control the valve repair device 1 to perform loading, delivery, and release functions during delivery. The second handle 32 is connected to the proximal end of the inner sheath catheter 22 and is used to control the bending of the distal end of the inner sheath catheter 22 to establish a minimally invasive interventional channel during delivery. The third handle 33 is connected to the proximal end of the outer sheath catheter 23 and is used to control the bending of the outer sheath catheter 23 to establish a minimally invasive interventional channel to the inner sheath catheter 22, the delivery catheter 21, and the valve repair device 1 during delivery.

[0057] Figures 2a-2b This is a schematic diagram of the valve repair device in this embodiment. Figures 2a-2b As shown, the valve repair device 1 includes a drive rod 100, a stop structure 200, and a clamping and lifting structure. The drive rod 100 is axially movable and passes through the stop structure 200, with the stop structure 200 located at the proximal end of the drive rod 100. The clamping and lifting structure is rotatably connected to the distal end of the drive rod 100 and also rotatably connected to the stop structure 200. This allows the clamping and lifting structure to rotate at both the connection points with the stop structure 200 and with the drive rod 100 when the drive rod 100 moves axially within the stop structure 200, thereby causing a change in the shape of the clamping and lifting structure to lift and clamp the valve leaflet.

[0058] The stop structure 200 includes a drive slider 210 and a locking member 220 disposed within the drive slider 210. The drive rod 100 passes through the drive slider 210 and the locking member 220, such that during the conveying process, the conveying conduit 21 drives the drive rod 100 to move axially within the drive slider 210. The locking member 220 switches between the axial movement state and the locking state of the drive rod 100 to switch between the release state and the locking state of the clamping and lifting structure.

[0059] The drive slider 210 includes a proximal end and a distal end along the axial direction from the proximal end to the distal end. The proximal end is generally tubular, and the distal end includes a first sidewall 211 and a second sidewall 212 that are arranged opposite each other. The proximal ends of the first sidewall 211 and the second sidewall 212 are both connected to the distal end of the proximal end. Preferably, the first sidewall 211 and the second sidewall 212 are arranged in parallel.

[0060] The clamping and lifting structure is used to lift and clamp the petals. The clamping and lifting structure includes a lifting component 400 and a gripper component 300. The gripper component 300 is disposed on the lifting component 400. The lifting component 400 is rotatably connected to the distal end of the drive slider 210 and is used to lift the petals. Specifically, the lifting component 400 is rotatably connected to the first side wall 211 and the second side wall 212. The gripper component 300 is used to cooperate with the lifting component 400 to clamp the petals.

[0061] The lifting component 400 includes two first connecting rods 410 and two second connecting rods 420. Each of the two first connecting rods 410 includes a first end 410a and a second end 410b. Each of the two second connecting rods 420 includes a first end 420a and a second end 420b. The second end 410b of each first connecting rod 410 is rotatably connected to the second end 420b of one second connecting rod 420. The first ends 410a of both first connecting rods 410 can be rotatably connected to the first sidewall 211 and the second sidewall 212 of the distal end. One interconnected first connecting rod 410 and the second connecting rod 420 are symmetrically arranged on both sides of the drive rod 100 with the other interconnected first connecting rod 410 and the second connecting rod 420. In detail, a connecting part is fixed to the distal end of the drive rod 100. The connecting part is fixed to the distal end of the drive rod 100. The connecting part has two ears on both radial sides of the drive rod 100. The first end 420a of each second connecting rod 420 is symmetrically and rotatably connected to one of the ears. The above structure makes the lifting component 400 adopt a symmetrical design, which reduces the number of parts involved and the number of processes, and is conducive to mass production. The bracket structure changes the axial length of the drive rod 100 between the connecting part and the drive slider 210 (i.e., the delivery conduit drives the drive rod 100 to slide axially in the drive slider 210), so that the quadrilateral formed by the sequentially connected first connecting rod 410 and second connecting rod 420 changes, thereby promoting the movement of the first connecting rod 410 and second connecting rod 420, and finally realizing that the first connecting rod 410 and second connecting rod 420 are in different postures (i.e., the lifting posture of the leaflets, the clamping posture, etc.). Furthermore, the second end 410b and the second end 420b, the first end 410a and the drive slider 210, and the first end 420a and the connector are all hinged together by the connecting shaft to achieve the connection between the two first connecting rods 410, the two second connecting rods 420, and the first connecting rod 410 and the second connecting rod 420. This makes the included angle θ between the two first connecting rods 410 0°~360°. Typically, when the included angle θ is 0°~20°, the clamping and lifting structure is closed, that is, the clamping and lifting structure closes the petals; when the included angle is 0°~360°, the clamping component clamps the petals; preferably, when the included angle θ is 90°~180°, the lifting component captures the petals in the most suitable state; when the included angle θ is 270°~360°, the lifting component facilitates release after the tendon is wrapped. The connecting shaft can be hinged to other parts by riveting, welding, or other methods.

[0062] The axial length of the first connecting rod 410 is less than the axial length of the second connecting rod 420, and the two sets of adjacent first connecting rods 410 and second connecting rods are symmetrically arranged along the drive rod 100, so that the lifting component 400 has a symmetrical design, so that the lifting component 400 realizes the function of lifting the leaflet of the valve repair device by means of the axis of the drive rod 100, and plays the function of closing the leaflet after the leaflet is clamped.

[0063] Figure 3 This is a schematic diagram of the structure of the first connecting rod in this embodiment. Figure 3 As shown, the first connecting rod 410 has a U-shaped strip structure, including a first bottom wall 411 and two first connecting walls 412 connected to both sides of the first bottom wall 411. The two first connecting walls 412 are arranged on the same side and opposite to each other, and are both located in the longitudinal direction of the first bottom wall 411. Each first connecting wall 412 has a first hinge hole 415 at the first end 410a and the second end 410b of the first connecting rod 410. The first hinge hole 415 is used to install a connecting shaft to form a hinge, thereby hinged the first connecting rod 410 and the driving slider 210 or the first connecting rod 410 and the second connecting rod 420. The first bottom wall 411 has a first notch 413 at the first end 410a of the first connecting rod 410. The first notch 413 is, for example, a rectangular notch, which is used to prevent interference between the first connecting rod 410 and the driving slider 210 during rotation. The first bottom wall 411 also has a plurality of first openings 414, which are used to sew or bond the gripper component 300.

[0064] Figure 4 This is a schematic diagram of the structure of the second connecting rod in this embodiment. Figure 4As shown, the second connecting rod 420 has a U-shaped strip structure, including a second bottom wall 421 and two second connecting walls 422 connecting both sides of the second bottom wall 421. The two second connecting walls 422 are on the same side and opposite to each other, and are both located in the longitudinal direction of the second connecting wall 422. Each second connecting wall 422 is provided with a second hinge through hole at the first end 420a and the second end 420b of the second connecting rod 420. The second hinge through hole is used to install a connecting shaft to form a hinge, thereby hinged the second connecting rod 420 and the driving rod 100 or the second connecting rod 420 and the first connecting rod 410. The first hinge hole 415 and the second hinge hole 426 that hinge the second connecting rod 420 and the first connecting rod 410 are arranged opposite each other. The second bottom wall 421 has a second notch 423 at the first end 420a of the second connecting rod 420 and a third notch 424 at the second end 420b. Both the second notch 423 and the third notch 424 are rectangular notches, designed to prevent interference between the second connecting rod 420 and the drive rod 100 during rotation. The second bottom wall 421 also has multiple first stitching holes 425, and a second stitching hole 428 is provided between the second hinged through holes at both ends of the second connecting wall 422. Both the first stitching holes 425 and the second stitching holes 428 are used for stitching or bonding the surface coating material. The second connecting wall 422 has a notch 427 near the first end 420a, designed to prevent interference between the first connecting rod 410 and the second connecting rod 420 during rotation. Furthermore, to avoid interference, the contours of the first connecting rod 410 and the second connecting rod 420 are formed into rigid parts by stamping, die casting, or bending. It should be noted that the length direction is... Figure 3 and Figure 4 The direction where the center, left, and right are located.

[0065] Figure 5 This is a schematic diagram of the gripper structure in this embodiment. Figure 5 As shown, please also refer to Figures 2a-2b In this embodiment, the gripper component 300 includes two grippers 310, each gripper 310 being fixed to a first connecting rod 410, and the two grippers 310 being symmetrically arranged on both sides of the drive rod 100. Furthermore, the grippers 310 are symmetrically fixed to the first bottom wall 411 of the first connecting rod 410. The grippers 310 are machined from thin metal sheets; specifically, the grippers 310 can be made from elastic or super-elastic materials such as stainless steel or nickel-titanium alloy.

[0066] Please continue reading. Figure 5In this embodiment, the gripper 310 includes a fixed part 311 and a movable part 312. A connecting end 310a connects the fixed part 311 and the movable part 312. The connecting end 310a is formed by connecting one end of the fixed part 311 and one end of the movable part 312, specifically through welding, sewing, bonding, or integral cutting. The fixed part 311 is elongated and has a first free end 311a opposite to the connecting end 310a. The movable part 312 is also elongated and has a second free end 312b opposite to the connecting end 310a. The movable part 312 can rotate about the fixed part 311 with the connecting end 310a as its center, as defined below. Figure 5 The connecting end 310a is the center of the circle. The direction from the connecting end 310a to the first free end 311a is the starting position, i.e., the 0° position. The direction of rotation is positive in the counterclockwise direction A, starting from the first free end 311a, and negative in the clockwise direction, starting from the first free end 311a. At this time, the position of the movable part 312 is the negative angle position, that is, the angle between the movable part 312 and the fixed part 311 is negative. The movable part 312 can rotate around the connecting end 310a in the counterclockwise direction, and the rotation angle is -180° to 270°. Preferably, the rotation angle is -45° to 180°. The movable part 312 has an opening 314, which is provided along the length of the movable part 312. When the movable part 312 rotates to the point where the fixed part 311 and the movable part 312 overlap, the fixed part 311 is located in the opening 314. The opening 314 allows the movable part 312 to pass through the overlapping position of the fixed part 311 from the outside of the fixed part 311 during rotation.

[0067] When the fixing part 311 is fixed to the first connecting rod 410, the movable part 312 is first rotated clockwise so that the included angle between the fixing part 311 and the movable part 312 is greater than or equal to 0. Then, the side of the fixing part 311 facing away from the rotation direction is fixed to the first connecting rod 410 by welding, sewing, bonding or other methods. At this time, due to the rotation of the movable part 312, there is a rebound force of elastic deformation between the movable parts 312, so that the movable part 312 is fitted to the first bottom wall 411, and the connecting end 310a is close to the first end 410a of the first connecting rod 410. The first free end 311a and the second free end 312b are both close to the second end 410b of the first connecting rod 410. The movable part 312 and the first bottom wall 411 have a mutual squeezing force, which is beneficial to provide a strong clamping force when the gripper 310 clamps the leaflet.

[0068] The fixing part 311 has a plurality of second openings 313, which overlap with the first opening 414 and are used together to fix the fixing part 311 to the first connecting rod 410. The second openings 313 can be regular shapes such as circles, semicircles, and squares.

[0069] The movable part 312 includes a through hole located at the second free end 312b, the through hole being used to accommodate a pull wire to provide a rotatable pulling force to the movable part 312 (providing such a force as...). Figure 5 The movable part 312 is subjected to a pulling force in the counterclockwise rotation direction AT, causing the movable part 312 to deform relative to the fixed part 311, thus changing the angle between the fixed part 311 and the movable part 312. Multiple evenly distributed barbs 316 are provided at both ends of the movable part 312 perpendicular to its length direction to achieve better clamping of the leaflets. Each gripper 310 has an individual pull wire, allowing the two grippers 310 to clamp the leaflets simultaneously or individually.

[0070] The valve repair device also includes a covering material that covers the outside of the support component and is sutured or bonded in place through the first suture hole 425 and the second suture hole 428. The main material of the covering material can be a woven fabric of PET or PTFE. Since the clamping and support component has a symmetrical structure, the valve repair device covered with the covering material also has a symmetrical structure. The overall structure has fewer components and fewer manufacturing processes, which is beneficial for mass production.

[0071] During operation, the delivery catheter drives the drive rod 100 to slide within the drive slider 210 of the stop structure 200, thereby changing the shape of the supporting component by varying the axial length of the drive rod 100 between the connector and the drive slider 210. First, the drive rod moves axially, delivering the valve repair device when the included angle θ between the two first connecting rods is 0° to 20°. After delivery to the target location, based on the actual anatomical structure, there are numerous chordae tendineae below the mitral valve leaflets, mainly concentrated below A1P1 and A3P3. When lifting the leaflet, the first connecting rod 410 may become entangled with the native chordae tendineae. In this case, it may be necessary to withdraw the valve repair device from below the leaflet (left ventricle) to above the leaflet (left atrium). Therefore, the axial length of the drive rod 100 between the connector and the drive slider 210 needs to be increased, gradually approaching the length of the first connecting rod 410 and the second connecting rod 420. When the included angle θ between the two first connecting rods 410 is 270°~360°, the lifting component can be freed from the entangled chordae tendineae (e.g., ...). Figure 6aAs shown), at this time, each of the grippers 310 can be attached to the first connecting rod 410 that fixes it, or the second free end 312b can be positioned close to the proximal end of the drive rod 100 by a pull wire. The radial dimension d of the lifting component in the drive rod 100 decreases as the included angle θ between the two first connecting rods 410 approaches 360°, making it easy for the lifting component to be removed from the chordae tendineae. When the lifting component is needed to lift the leaflet after being released from the chordae tendineae, the second free end 312b of each of the grippers 310 is brought close to the drive rod by a pull wire. The drive rod 100 is positioned near the proximal end of the connector and gradually decreases in axial length between the connector and the drive slider 210 to capture the leaflets. When the angle between the two first connecting rods is 0° to 360°, the clamping member holds the leaflets. The optimal state for capturing the leaflets (i.e., the state where the clamping member more easily holds the leaflets) is when the angle θ between the two first connecting rods 410 is 90° to 180°. This angle prevents the leaflets from slipping during closing and withdraws the tension provided by the pull wire, causing the movable part 312 to spring back and clamp the leaflets (e.g., ...). Figure 6b As shown), at this time, the two first connecting rods 410 and the drive rod 100 form an I-shape or a symmetrical V-shape, and the two second connecting rods 420 and the drive rod 100 form a symmetrical V-shape; after lifting and clamping the leaflets, when the axial length of the drive rod 100 between the connector and the drive slider 210 decreases and gradually approaches 0, and the included angle θ between the two first connecting rods 410 is 0°~20°, the clamping and lifting structure closes, and the leaflets close to achieve edge-to-edge technology (such as...). Figure 6c (As shown).

[0072] In summary, this invention provides a valve repair device, a valve repair system, and its operating method. The lifting component of the valve repair device can lift, clamp, and lock the valve leaflets at any angle from 0° to 360°. Leaflets can be clamped individually or simultaneously, greatly increasing the flexibility and convenience of the surgeon's operation. Furthermore, during surgery, if the valve repair device gets caught on the chordae tendineae, the flexible structure allows for a larger clamping angle and a smaller diameter in the open state, making release easier. The entire structure employs a completely symmetrical design, resulting in fewer types of parts and fewer manufacturing processes, which is more conducive to mass production.

[0073] Furthermore, it should be noted that, unless otherwise specified or indicated, the terms "first" and "second" in the specification are used only to distinguish the various components, elements, steps, etc. in the specification, and not to indicate the logical or sequential relationships between the various components, elements, steps, etc.

[0074] It is understood that although the present invention has been disclosed above with reference to preferred embodiments, these embodiments are not intended to limit the present invention. For any person skilled in the art, many possible variations and modifications can be made to the technical solutions of the present invention based on the disclosed technical content, or equivalent embodiments can be modified accordingly, without departing from the scope of the present invention. Therefore, any simple modifications, equivalent changes, and modifications made to the above embodiments based on the technical essence of the present invention without departing from the content of the present invention shall still fall within the protection scope of the present invention.

Claims

1. A valve repair device, characterized in that, It includes a stop structure, a drive rod, and a clamping and lifting structure. The drive rod is axially movable and passes through the stop structure. The proximal end of the drive rod is detachably connected to the distal end of the delivery conduit. The stop structure is located at the proximal end of the drive rod and is used to switch the axial movement state and locking state of the drive rod. The clamping and lifting structure includes a clamping component and a lifting component. The lifting component is a rigid structure. The clamping component includes two jaws. The lifting component includes two first connecting rods and two second connecting rods. One end of each first connecting rod and one end of each second connecting rod are rotatably connected. The other end of each first connecting rod is rotatably connected to the distal end of the stop structure. The other end of each second connecting rod is rotatably connected to the distal end of the drive rod. Each jaw is respectively disposed on one of the first connecting rods. The jaws cooperate with the first connecting rods to clamp the leaflets. The lifting component changes the shape of the first and second connecting rods through the axial movement of the drive rod, so that the lifting component can achieve leaflet lifting, leaflet clamping, and chordae tendineae release within a range of 0° to 360°. Wherein, the included angle between the two first connecting rods is 0°~360°; when the included angle between the two first connecting rods is 0°~20°, the clamping and lifting structure is closed, and the leaflets close; when the included angle between the two first connecting rods is 90°~180°, the lifting component captures the leaflets; and when the included angle between the two first connecting rods is 270°~360°, the lifting component is released from the wrapped tendon cord; The gripper includes a fixed part and a movable part. One end of the fixed part and one end of the movable part are connected to form a connecting end. The fixed part has a first free end opposite to the connecting end, and the movable part has a second free end opposite to the connecting end. The fixed part is fixed to the first connecting rod, and the connecting end is located close to the drive rod. The movable part is fitted against the side of the first connecting rod near the proximal end, and there is a negative angle between the fixed part and the movable part. The movable part can rotate around the connecting end, such that when the angle between the fixed part and the movable part is greater than or equal to 0°, a rebound force is generated between the fixed part and the movable part, and the rebound force increases as the angle increases.

2. The valve repair device as described in claim 1, characterized in that, The two first connecting rods and the two second connecting rods are symmetrically arranged on both sides of the drive rod.

3. The valve repair device as described in claim 1, characterized in that, The two first connecting rods, the two grippers, and the two second connecting rods are symmetrically arranged on both sides of the drive rod.

4. The valve repair device as described in claim 1, characterized in that, The gripper is made of an elastic material.

5. The valve repair device as described in claim 1, characterized in that, The gripper is made of a superelastic material.

6. The valve repair device as described in claim 1, characterized in that, The second free end has a through hole for connecting the distal end of the pull wire. When the proximal end of the pull wire provides a pulling force, the second free end moves away from the first free end and rotates as the pulling force moves. As the movable part rotates, the spring force between the movable part and the fixed part increases.

7. A valve repair system, characterized in that, The device includes a valve repair apparatus as described in any one of claims 1 to 6, and a delivery device, the delivery device including a delivery catheter, the distal end of which is detachably connected to the proximal end of a drive rod, the delivery catheter and the drive rod being axially movable through a stop structure, and the shape of the lifting component changing when the delivery catheter drives the drive rod to move axially, so as to achieve chordae tendineae release, leaflet lifting, clamping and closing.

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