Valve leaflet anchor implantation device

Abstract

The application provides an artificial chordae tendineae implantation device capable of clamping and fixing a valve, comprising a proximal handle operation device, a distal clamping device and at least one set of puncture devices, and further comprising a control device linked with the clamping device, wherein the clamping device comprises a first clamp head and a second clamp head, the control device controls the relative displacement of the first clamp head and the second clamp head through a linkage mechanism, and the displacement is defined as X1, so that the clamping device can clamp valves with different thicknesses. Through the clamping structure of the implantation device, the applicability and compatibility of the artificial chordae tendineae for valves with different thicknesses are improved.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and to a device for repairing heart valve defects, specifically to an artificial chordae tendineae implantation device that can clamp and fix the valve. Background Technology

[0002] Mitral regurgitation is one of the most common valvular heart diseases today. The main causes include rheumatic heart disease, mitral valve myxoid degeneration, ischemic heart disease, and cardiomyopathy, leading to lesions in the mitral valve structure, including the annulus, leaflets, chordae tendineae, and papillary muscles, resulting in the inability of the mitral valve leaflets to close completely. Surgical treatment is an effective method for mitral regurgitation; however, due to the significant trauma, complications and mortality rates are higher in elderly patients and those with multiple comorbidities. Therefore, minimally invasive interventional surgery is now a better choice for most heart diseases. The main interventional treatments include artificial chordae tendineae implantation, mitral valve annulus repair, and mitral valve edge-to-edge repair. Among these, implanting artificial chordae tendineae on the leaflets can effectively treat mitral regurgitation caused by chordae tendineae rupture or leaflet prolapse while maintaining the physiological integrity of the mitral valve structure.

[0003] Existing chordae tendineae implantation suture devices have some problems during the suture insertion process:

[0004] For example, one existing technique for implanting artificial chordae tendineae using a hooked needle to suture valve perforations has a relatively large puncture point, causing significant damage to the valve and posing a risk of valve tearing. Furthermore, the success rate of hooking the artificial chordae tendineae with the needle is low, resulting in a low overall surgical success rate and prolonged operation time. Additionally, only one set of artificial chordae tendineae can be implanted at a time, requiring multiple sutures per surgery, making the procedure complex and time-consuming.

[0005] For example, there is an existing artificial chordae tendineae implantation device, which has certain limitations on valve thickness and is not compatible with chordae tendineae implantation on valves of different thicknesses or in different states, resulting in high limitations. It can only rigidly clamp valves of different thicknesses, and cannot fix them for a long time and release them at any time. During the chordae tendineae implantation process, it will cause secondary damage to the valve that is constantly moving in the body, and also greatly reduce the success rate of the surgery. Moreover, it can only perform rigid punctures on the valve. With the continuous movement of the valve, there is a risk of the valve puncture hole enlarging or even tearing. Summary of the Invention

[0006] The present invention mainly provides an artificial chordae tendineae implantation device that can clamp and fix valves. The technical problem to be solved is that, in view of the defects of the prior art, there are certain limitations on the thickness of the valve to be clamped, and it is not compatible with the implantation of chordae tendineae for valves of different thicknesses or in different states. It has high limitations. For valves of different thicknesses, it can only be rigidly clamped, and it cannot be fixed for a long time and released at any time. During the implantation of chordae tendineae, it will cause secondary damage to the valve that is constantly moving in the human body, and also greatly reduce the success rate of the surgery.

[0007] To solve the above-mentioned technical problems, the present invention adopts the following technical solution:

[0008] An artificial chordae tendineae implantation device for clamping and fixing valves includes a proximal handle operating device, a distal clamping device, and at least one set of puncture devices. The device is characterized by further including a control device linked to the clamping device. The clamping device includes a first clamp and a second clamp. The control device controls the relative displacement of the first clamp and the second clamp via a linkage mechanism. The displacement is limited to X1, allowing the clamping device to clamp valves of different thicknesses.

[0009] In one specific embodiment, the control device is located in the handle clamping operation device. The control device includes an operable rotating component located on the surface of the handle clamping operation device, a rotating component connector located inside the handle clamping device and connected to the rotating component, and a sliding component that is linked with the rotating component connector.

[0010] In one specific embodiment, the artificial tendon chord implantation device further includes a clamping control member connected to the first clamp, and a sliding member connected to the clamping control member, wherein the sliding member controls the relative position of the first clamp and the second clamp through the clamping control member.

[0011] In one specific embodiment, the rotating member has a pivot located within the handle operating device, and the rotating member performs circular motion about the pivot as a central axis.

[0012] In one specific embodiment, the handle operating device includes an upper shell assembly and a lower shell assembly, the upper shell assembly and the lower shell assembly forming a first groove and a second groove, the rotating member having a third groove and a fourth protrusion, the rotating member having an initial position state, when the rotating member is in the initial position state, the third groove is in interference fit with the first groove, and the fourth protrusion is in interference fit with the second groove.

[0013] In one specific embodiment, the rotating component has a connecting hole, one end of the rotating component connector is connected to the connecting hole, and the other end is connected to the sliding component.

[0014] In one specific embodiment, the rotation angle of the rotating component is set to α, the horizontal displacement of the connecting hole is set to X2, the horizontal displacement of the rotating component connector is X3, and X2 = X3.

[0015] In one specific embodiment, the slider has a horizontal sliding displacement set to X4, where X3 = X4 = X1.

[0016] In one specific embodiment, an elastic member is further included, the elastic member being located near the proximal end of the slider. When the slider is displaced towards the proximal end, the slider compresses the elastic member, and the compression displacement is set to X5, where X5 = X1.

[0017] In one specific embodiment, the rotating component is an elastic member with a reset state. When the rotating component is in the reset state, it is in an interference fit with the upper shell assembly, and at this time, the rotating component is in the initial position state.

[0018] In one specific embodiment, the device further includes a valve capture feedback device for determining whether the valve has been correctly captured. The handle operation device also includes a feedback operation mechanism connected to the valve capture feedback device. The valve capture feedback device includes a limiting block located at the distal end of the sliding block. The limiting block has a first state and a second state. The sliding member has a groove adapted to the limiting block. When the limiting block is in the first state, the limiting block can pass through the groove of the sliding block.

[0019] In one specific embodiment, the feedback operation mechanism includes a detection button, and the clamping control component is connected to a rotation limiting structure and a torsion spring structure. The torsion spring structure is pre-tightened and limitedly installed in the lower shell assembly, and the torsion spring structure is connected to the detection button.

[0020] In one specific embodiment, the detection button has an initial pointing direction and a feedback pointing direction. When the detection button is in the initial pointing direction, the limiting block is in a first state.

[0021] When the detection button is in the feedback pointing direction, the clamping control component rotates by a corresponding angle, so that the limiting block is in the second state.

[0022] The beneficial effects of this invention are as follows: Unlike existing technologies, this invention provides an artificial chordae tendineae implantation device capable of clamping and fixing valves, comprising: a proximal handle operating device, a distal clamping device, and at least one set of puncture devices. It also includes a control device linked to the clamping device. The clamping device includes a first clamp and a second clamp. The control device controls the relative positions of the first clamp and the second clamp through a linkage mechanism, enabling the clamping device to clamp valves of different thicknesses. The rotating member is an elastic component with a reset state. When the rotating member is in the reset state, it is in an interference fit with the upper shell assembly. At this time, the rotating member is in its initial position, utilizing the structural elasticity of the rotating member to achieve flexible clamping of the valve.

[0023] The flexible clamping structure of the implantation device described above allows for the implantation of artificial chordae tendineae into valves of varying thicknesses. This flexible clamping allows for the long-term fixation and release of valves of different thicknesses, protecting valves of varying thicknesses while maintaining stable clamping over extended periods. It also reduces the probability of valve movement enlarging the puncture site during the puncture process. Therefore, the structure of this invention is more flexible and has a wider range of applications in terms of valve clamping, fixation, and puncture, offering better applicability to valves in different states, improving product usability, and increasing surgical success rates. Attached Figure Description

[0024] To more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings used in the description of the embodiments will be briefly introduced below. Obviously, the 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.

[0025] Figure 1 This is a schematic diagram of the artificial tendon chord implantation device of the present invention;

[0026] Figure 2 This is a schematic diagram of the clamping device structure of the artificial tendon chord implantation device of the present invention;

[0027] Figure 3 This is a schematic cross-sectional view of the second clamp of the artificial tendon chord implantation device of the present invention;

[0028] Figure 4 This is a schematic diagram of the initial state of the artificial tendon chord implantation device of the present invention when it is not clamped;

[0029] Figure 5 This is a schematic diagram showing the features of the rotating component of the artificial tendon chord implantation device of the present invention;

[0030] Figure 6This is a schematic diagram showing the features of the upper shell assembly of the artificial tendon chord implantation device of the present invention;

[0031] Figure 7 This is a schematic diagram of the initial internal state of the artificial tendon chord implantation device of the present invention before detection;

[0032] Figure 8 This is a schematic diagram of the artificial tendon chord implantation device of the present invention when the clamping device is opened;

[0033] Figure 9 This is a schematic diagram showing the movement relationship between the rotating buckle, the rotating buckle connector, and the sliding component of the artificial tendon chord implantation device of the present invention;

[0034] Figure 10 This is a schematic diagram of the hole position of the rotating buckle connecting hole of the artificial tendon chord implantation device of the present invention before movement;

[0035] Figure 11 This is a schematic diagram of the hole position after the rotating buckle connecting hole of the artificial tendon chord implantation device of the present invention has been moved;

[0036] Figure 12 This is a schematic diagram comparing the hole positions of the rotating buckle connecting hole of the artificial tendon chord implantation device of the present invention before and after movement;

[0037] Figure 13 This is a schematic diagram showing the relative positions of the rotating buckle and the rotating buckle connector of the artificial tendon chord implantation device of the present invention before movement;

[0038] Figure 14 This is a schematic diagram showing the relative positions of the rotating buckle and the rotating buckle connector of the artificial tendon chord implantation device of the present invention after movement;

[0039] Figure 15 This is a schematic diagram comparing the relative positions of the rotating buckle and the rotating buckle connector of the artificial tendon chord implantation device of the present invention before and after movement;

[0040] Figure 16 This is a schematic diagram of the rotating buckle connector of the artificial tendon chord implantation device of the present invention;

[0041] Figure 17 This is a schematic diagram showing the details of the rotating buckle fixing component of the artificial tendon chord implantation device of the present invention.

[0042] Reference numerals: 1. Clamping device; 2. Handle operating device; 3. Rotating component; 4. Puncture needle device; 6. Detection button; 7. Guide tube; 8. Sliding component; 9. Rotating component connector; 111. First clamp; 112. Second clamp; 13. Sliding component limiting block 1; 14. Sliding component limiting block 2; 15. Clamping control component; 19. Limiting sleeve 1; 20. Limiting sleeve 2; 21. Upper shell assembly; 23. Sliding component elastic member 1; 24. Sliding component elastic member 2; 25. Rotation limiting structure 1; 26. Rotation limiting... Position structure 2; 27, stitch box; 35, third groove; 36, rotating component connecting hole; 37, fourth protrusion; 38, first groove; 39, second groove; 81, sliding component groove; 91, rotating component connector and sliding component connecting rod; 92, rotating component connector and rotating component connecting hole connecting rod; 100, horizontal movement line of the sliding component; 120, hole position of the rotating component connecting hole after movement; 130, hole position of the rotating component connecting hole before movement; 611, detection button feedback pointing direction; 612, detection button initial pointing direction. Detailed Implementation

[0043] The present application will now be described in further detail with reference to the accompanying drawings and embodiments. It should be noted that the following embodiments are for illustrative purposes only and do not limit the scope of the application. Similarly, the following embodiments are only some, not all, embodiments of the present application, and all other embodiments obtained by those skilled in the art without inventive effort are within the scope of protection of this application.

[0044] A component is referred to as being "fixed to" or "set on" another component, and it may be located directly or indirectly on that other component. When a component is referred to as being "connected to" another component, it may be directly or indirectly connected to that other component.

[0045] The terms "first," "second," and "third" in this application are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Therefore, a feature defined as "first," "second," or "third" may explicitly or implicitly include at least one of that feature. In the description of this application, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified. All directional indications (such as up, down, left, right, front, back, etc.) in the embodiments of this application are only used to explain the relative positional relationships and movements between components in a specific orientation (as shown in the figures). If the specific orientation changes, the directional indications also change accordingly. Furthermore, the terms "comprising" and "having," and any variations thereof, are intended to cover non-exclusive inclusion. A process, method, system, product, or device that includes a series of steps or units is not limited to the listed steps or units, but may optionally include steps or units not listed, or may optionally include other steps or units inherent to these processes, methods, products, or devices.

[0046] The terms "axial" and "radial" refer to the length of the entire device or component as "axial" and the direction perpendicular to the axial direction as "radial".

[0047] The term "circumferential" refers to the direction along the circumference of a circle.

[0048] "Far end" and "near end" are based on the operator; the position relatively closer to the operator is considered near, and the position farther away from the operator is considered far.

[0049] The terms used above are for ease of description only and should not be construed as limitations on this technical solution.

[0050] In this document, the term "implementation" means that a specific feature, structure, or characteristic described in connection with an implementation may be included in at least one implementation of this application. The appearance of this phrase in various places in the specification does not necessarily refer to the same implementation, nor is it a separate or alternative implementation mutually exclusive with other implementations. It will be explicitly and implicitly understood by those skilled in the art that the implementations described herein can be combined with other implementations.

[0051] Please see Figure 1 The diagram shows an assembly of the artificial chordae tendineae implantation device for clamping and fixing valves provided by the present invention. It includes a distal valve clamping device 1, a proximal handle operating device 2, and at least one set of valve puncture devices 4, including a left puncture assembly and a right puncture assembly. The handle operating device is equipped with a rotating component 3, one embodiment of which is a lever / clamp mechanism, allowing the user to rotate the lever / clamp mechanism.

[0052] In one embodiment, the handle operating device of the present invention includes an upper shell assembly 21, a lower shell assembly, a locking element, a feedback operating mechanism, and a torsion spring assembly. The distal valve clamping device 1 is connected to the proximal handle operating device 2 via a conduit 7, which is a hollow structure and contains a clamping control element 15. The upper shell assembly 21, the lower shell assembly, the locking element, and the feedback operating mechanism 6 are all made of polymer material by high temperature and high pressure injection molding, and the torsion spring assembly is made of metal. The feedback operating mechanism includes a detection button 6, and the torsion spring assembly is installed in the clamping device 1 via the clamping control element 15. The locking element is interference-fitted or fixed to the lower shell assembly by adhesive.

[0053] Furthermore, in order to implant multiple sets of sutures at once to form artificial chordae tendineae M, multiple sets of the clamping control 15, valve puncture device 4, and valve capture feedback device are provided. Preferably, the clamping control 15, valve puncture device 4, and valve capture feedback device are all provided in pairs. That is, multiple sets of the clamping control 15, valve puncture device 4, and valve capture feedback device are provided, preferably in pairs with intervals.

[0054] like Figure 2 As shown, the clamping device 1 includes a first clamp 111 and a second clamp 112 located at the distal end, a limiting block 13 and a limiting block 14 located at the distal end of the slider, and a rotation limiting structure located at the proximal end of the slider. One type of rotation limiting structure is a rotation limiting block 25 and a rotation limiting block 26, and a torsion spring structure connected to the rotation limiting blocks. Specifically, the torsion spring structure can be a torsion spring, having two torsion springs, which are respectively connected to the rotation limiting blocks 25 and 26. The torsion springs are pre-tensioned and connected to the rotation limiting blocks and installed in the lower shell assembly. The rotation limiting blocks restrict the pre-tensioned rotational displacement of the torsion springs. An elastic member is provided at the proximal end of the slider, one specific embodiment being a spring. The slider is connected to the springs 23 and 24 through the clamping control member 15. Moving the slider 8 towards the proximal end will compress the springs 23 and 24. A limiting block 13 and a limiting block 14 are provided at the distal end of the slider 8 to limit the movement of the slider 8. A rotating connector 3 is connected to the sliding member 8. Specifically, the upper surface of the sliding member 8 has a groove. One embodiment of the rotating connector is a lever connector, which has a "U"-shaped structure and has a rotating connector connecting to the sliding member rod 91 and a rotating connector connecting to the rotating member connecting hole rod 92. The rotating connector connecting to the sliding member rod 91 is connected to the groove on the upper surface of the sliding member, and the displacement of the lever connector causes the displacement of the sliding member. A suture box is connected to the proximal end of the clamping control member 15.

[0055] like Figure 3As shown, the distal clamping device is used to clamp the valve. After clamping, the valve is punctured by the valve puncture device 4, and the artificial chordae tendineae M are passed through the valve, pulled out of the body, knotted, and then returned to the valve suture site. The clamping device includes a first clamp 111 and a second clamp 112 at the distal end, both of which have clamping surfaces that are used to clamp the valve. The first clamp 111 is conical in shape, and the second clamp 112 is fixedly connected to the catheter 7 or the two are integrated into one structure. The clamping surfaces of the first clamp 111 and the second clamp 112 are both inclined, preferably 60°. For secure clamping, the clamping surfaces of the two clamps are preferably toothed to increase the clamping force. The clamping device can be made of polymer materials such as ABS, PC, PEEK, etc., or metal materials such as stainless steel, cobalt-chromium alloy, etc.

[0056] The first clamp 111 is fixed with a clamping control component 15. The clamping control component 15 is sequentially inserted into the first clamp 111 and the conduit 7. The distal end of the clamping control component 15 is fixedly connected to the second clamp 112, and the proximal end extends out of the conduit 7 and connects to the clamping control device. The clamping control device includes a rotating component 3 located on the upper shell surface of the proximal handle operating device. When the clamping control device is activated, the first clamp 111 and the second clamp 112 close and clamp or separate. The clamping control component 15 is rod-shaped and can be a solid rod or a hollow rod. To make full use of each component, the clamping control component 15 is preferably a hollow rod, through which a suture is inserted as an artificial tendon chord M. The artificial tendon chord M is usually made of e-PTFE suture or PET suture, and its outer diameter is 0.2-0.5 mm. At least one clamping control component 15 is provided, and multiple clamping control components can be provided depending on the number of artificial tendon chords M. The connection methods between the clamping control component 15 and the first clamp 111 mainly include welding, snap-fitting, and bonding.

[0057] Furthermore, the surface of the first chuck 111 is made of polymer material, and the clamping control component 15 is a metal tube structure. The metal tube and the polymer material are combined and molded using a high-temperature and high-pressure injection molding process. The first chuck 111 has holes for fixing the buckle and channels for artificial tendons to pass through. Figure 3As shown, the metal tube of the second clamp 112 is made in the same way as the polymer material, and contains a polygonal rod that can detect whether the valve is captured. The rotating limiting block 25, rotating limiting block 26, sliding limiting block 13, and sliding limiting block 14 can be made of metal and welded to the clamping control component 15 of the first clamp 111, or they can be polymer material tubes fixed to the clamping control component 15 using a heat-shrink process. The limiting sleeves 19 and 20 are also fixed to the metal tube of the clamping control component in the same way. After the first clamp 111 is installed, the first clamp 111, sliding limiting block 13, sliding limiting block 14, sliding element 8, spring 23, spring 24, limiting sleeve 19, and limiting sleeve 20 are then sequentially fixed to the two metal tubes of the second clamp 112 using specific tooling fixtures to form a clamping device.

[0058] In the overall assembly, the left and right puncture components pass through the clips and the clips are inserted into the clamping component channel already installed in the lower shell component 21. Then, the rotating buckle 3 is installed on the rotating buckle connector 9, the upper shell component 21 is installed, and they are assembled together using screws or ultrasonic welding to form a rigid main body.

[0059] Example 1:

[0060] like Figure 5 The diagram shows the original state of the artificial chordal implantation device when it is not in operation. The rotating component 3 can specifically be a rotating lever. The handle operating device 2 includes an upper shell assembly 21 and a lower shell assembly. The groove structures of the upper shell assembly 21 and the lower shell assembly form a first groove 38 and a second groove 39. The rotating lever 3 has a corresponding third groove 35 and a fourth protrusion 37. At this time, the rotating lever 3 is in its initial position, i.e., the original state of the artificial chordal implantation device when it is not in operation. In this state, the third groove 35 of the rotating lever 3 is press-fitted with the first groove 38 of the upper and lower shell assemblies, and the fourth protrusion 37 of the rotating lever 3 is press-fitted with the second groove 39 of the upper and lower shell assemblies. Inside the artificial chordal implantation device, the rotating lever 3 forms a linkage structure with the second clamp 112 of the clamping device through the rotating lever connector 9. Externally, the artificial tendon chord implantation device shows that the rotating buckle 3 uses the circumferential feature grooves one and two of the upper and lower shells as support points. It rotates along a pivot axis, which is the central axis of the third groove 35 of the rotating buckle 3, to perform circular motion. When the rotating buckle 3 moves distally, the clamping control member 15 located inside the first clamp 111 causes a relative displacement between the first clamp 111 and the second clamp 112 of the distal clamping device, set as X1. Figure 9 As shown, it is used to hold the valve.

[0061] Furthermore, during the movement of the rotary buckle 3 at its distal end, the rotary buckle connector 9 connected to the rotary buckle 3 also begins to move. Specifically, one end of the rotary buckle 3 has a connecting hole 36, and one end of the buckle connector 9 is connected to the connecting hole 36. During the movement of the other end of the rotary buckle 3, it drives the connecting hole 36 to move, generating a horizontal displacement, set as X2. Figure 10 As shown. Before the rotating lever 3 moves, the horizontal angle between the lever 3 and the artificial tendon chord implantation device is set to a1. When the rotating lever 3 moves distally, the horizontal angle between the lever 3 and the artificial tendon chord implantation device changes to a2, and the connecting hole 130 of the rotating lever also moves accordingly. Figure 12 As shown, the horizontal movement distance generated by the front and rear holes at this time is X2. Furthermore, the latching connector 9, which cooperates with the rotating latching component 3, simultaneously generates a horizontal displacement, set as X3, as shown... Figure 14-16 As shown, the larger the horizontal displacement X2 of the connecting hole 36, the larger the horizontal displacement X3 of the rotating buckle connector 9 moving to the far end. Since the entire clamping device is rigidly connected, the other end of the rotating buckle connector 9 is connected to the sliding member 8 in the first clamp 111 and embedded in the structural groove of the sliding member. Under the limitation of the clamping control member 15, the sliding member 8 can only move horizontally. The horizontal displacement generated by the sliding member 8 is set to X3, and the displacement generated by the first clamp 111 and the second clamp 112 of the far-end clamping device is set to X1. Therefore, it can be concluded that X2 = X3 = X4 = X1. That is, the change in rotation angle a1→a2 generated by the rotating buckle 3 causes the connecting hole 36 at one end of the rotating buckle to generate a horizontal displacement of X2, the value of which is equal to the horizontal displacement X3 generated by the rotating buckle connector 9 connected to the connecting hole, and the value of which is equal to the horizontal displacement generated by the sliding member 8 connected to the other end of the rotating buckle connector 9. The value of which is equal to the relative displacement X1 generated by the two clamps of the clamping device, that is, the thickness of the valve clamped by the clamping device.

[0062] The distance X1 represents the thickness range of the valve that the artificial chordae tendineae implantation device can hold. The larger X1 is, the greater the range of the valve that it can hold.

[0063] Furthermore, since X2 = X3 = X4 = X1, if the displacement X2 of the rotating buckle fastener connection hole 36 remains unchanged, then... Figure 17 As shown, increasing the distance of the lever connector L1 increases the horizontal displacement X3 of the rotating lever connector, thus increasing the range of valve thickness that can be clamped.

[0064] Furthermore, when L1 in the rotating buckle fastener remains unchanged, such as Figure 13As shown, increasing the distance R1 between the center of the rotating buckle fastener connection hole and the center of the rotating buckle fastener shaft will increase the horizontal displacement X2 of the corresponding connection hole, thereby increasing the horizontal displacement X3 of the rotating buckle fastener connection, which in turn increases the thickness range of the clamping valve.

[0065] Furthermore, with the distance R1 between the center of the rotating buckle connecting hole 36 and the center of the rotating buckle shaft, the horizontal displacement X2 generated by the corresponding connecting hole, and the rotating buckle connector L1 and the sliding member remaining unchanged, reducing the distance between the center of the sliding member groove and the rotation center of the buckle, and setting it to R2, can increase the rotation angle of the rotating buckle, that is, increase the difference between a2 and a1, which can increase the distance of the displacement X2 of the rotating buckle connecting hole, that is, increase the distance of the relative displacement X1 generated by the two clamps of the clamping device, that is, increase the thickness range of the clamping valve.

[0066] Example 2:

[0067] Because the valve is constantly moving during the actual surgery, and it is inside the human body, each time the clamping device is operated by rotating the lever to try to clamp the valve, it is necessary to detect whether the valve has been successfully captured. Therefore, the artificial chordae tendineae implantation device also includes a valve capture feedback device for determining whether the valve has been correctly captured, and a feedback operation mechanism connected to the valve capture feedback device.

[0068] When the artificial chordae tendineae implantation device is inserted into the valve through the apex of the heart with the first clamp 111 and the second clamp 112 of the clamping device in the closed state, and an ultrasound device is placed nearby to assist in the exploration, when the valve is inserted into the predetermined position, the rotating lever 3 is turned to open the first clamp 111 and the second clamp 112 to clamp the valve. Figure 8 As shown, the sliding member 8 moves to the far end under the combined action of the rotating buckle member 3 and the rotating buckle connector 9. At this time, the sliding member limiting blocks 13 and 14 are in the first state, which is preferably the horizontal state. The sliding member has a groove 81 that is adapted to the limiting block, so that the sliding member limiting block can pass through the groove left by the sliding member without any interference.

[0069] Furthermore, after the first clamp 111 and the second clamp 112 hold the valve, in the feedback operation mechanism, one embodiment of which is a detection button 6, before the detection button 6 is released, the sliding member 8 is controlled to move proximally by rotating the lever fastener 3. Throughout the process, there will be no interference. Further, the clamping device is closed by rotating the lever fastener 3 to clamp the valve. The valve is an elastic body composed of biological cells. To better fix the constantly moving valve in the heart, after the rotating lever fastener 3 clamps the valve, the valve needs to be flexibly fixed. At this time, a slight force is applied to continue moving the rotating lever fastener 3 proximally. One side of the sliding member 8 connected to the rotating lever fastener is provided with an elastic component, preferably a spring structure, spring 23 and spring 24. At this time, the spring is compressed by the sliding member 8, generating a reverse pressure. The compression displacement is set to X5. When the compression displacement X5 = X1, that is, the displacement of the first clamp 111 and the second clamp 112 of the clamping device, the rotating lever... When the fastener is in the reset state, the rotating fastener is in an interference fit with the upper shell assembly. At this time, the rotating fastener 3 is in the initial position state, that is, the third groove 36 of the rotating fastener is in an interference fit with the first groove 38 of the upper and lower shell assemblies of the handle operating device, and the fourth protrusion 37 of the rotating fastener is in an interference fit with the second groove 39 of the upper and lower shell assemblies of the handle operating device. The above structure utilizes the structural elasticity of the fastener itself to form an interference fit with the upper shell, creating a locking position that can only be released by applying strong force, thus ensuring that the rotating fastener 3 is in the reset state and improving the valve clamping force.

[0070] Furthermore, such as Figure 17 As shown, the detection button 6 has an initial pointing direction 612 and a feedback pointing direction 611. The detection button 6 is connected to a rotation limiting structure and a torsion spring structure. The rotation limiting structure consists of rotation limiting blocks 25 and 26. As shown in the figure, before the detection button 6 is released, it is pre-assembled into the transverse slot of the lower shell assembly by the limiting of the rotation limiting blocks 25 and 26 and the compression of the torsion spring. At this time, the detection button 6 points to the initial pointing direction 612, which can be a red marking surface in the lower shell assembly. When the valve is being checked for proper clamping, the detection button 6 is moved from the initial pointing direction 612 to one side and released. The detection button 6 rotates a certain angle, preferably 90 degrees, so that the pointer points exactly to the feedback pointing direction 611, which can be the green marking surface of the lower shell assembly. At this time, under the action of the torsion spring, the rotation limiting blocks 25 and 26 and the sliding limiting blocks 13 and 14, which are rigidly connected to the clamping control metal tube 15 in the first clamp 111, also rotate 90 degrees at the same time. At this time, the sliding limiting blocks 13 and 14 are just stuck on the other side of the sliding member 8 connected to the rotation lever buckle 3. The sliding limiting blocks 13 and 14 are in the second state. In the above state, if the rotation lever buckle 3 is moved to the far end again, the sliding member rigidly connected in the first clamp will be stuck by the sliding limiting blocks 13 and 14 and cannot be opened again.

[0071] Furthermore, the clamping device clamps the valve opening distance X1. During the process of the rotating lever 3 returning to its locking position, the springs 23 and 24 connected to the sliding member 8 are compressed. The compression displacement X5 exactly cancels out the opening distance of the clamping device, that is, X5 = X1. This allows the rotating lever 3 to not only return to its locking position and achieve the reset state, but also to form a stable flexible clamping force on the valve through the counter-compression force of the springs 23 and 24. At this time, the sliding member limiting blocks 13 and 14, under the rotation of the detection button 6, form a locking position with the sliding member 8 of the first clamp 111, which is exactly locked on the other side of the compressed springs 23 and 24 connected to the sliding member 8, thus locking the compressed springs and indirectly improving the stability of the lever fixing the valve. On the outer surface of the artificial chordae tendineae implantation device, the clamping device holds the upper clamp of the valve. As the rotating buckle 3 moves proximally, it simultaneously clamps the valve. Finally, the rotating buckle 3 is successfully locked in place. After releasing the probe button 6, the indicator shows the feedback direction 611, which means that the clamping device has successfully captured and fixed the valve.

[0072] Unlike existing technologies, the present invention provides an artificial chordae tendineae implantation device for clamping and fixing valves, comprising: a proximal handle operating device, a distal clamping device, and at least one set of puncture devices, and a control device linked to the clamping device. The clamping device includes a first clamp and a second clamp. The control device controls the relative displacement of the first clamp and the second clamp through a linkage mechanism. The displacement is limited to X1, so that the clamping device can clamp valves of different thicknesses. The rotating member is an elastic member with a reset state. When the rotating member is in the reset state, it is in an interference fit with the upper shell assembly. At this time, the rotating member is in its initial position state, and the flexible clamping of the valve is achieved by utilizing the structural elasticity of the rotating member. The flexible clamping structure of the implantation device described above allows for the implantation of artificial chordae tendineae into valves of varying thicknesses. This flexible clamping allows for the long-term fixation and release of valves of different thicknesses, protecting valves of varying thicknesses while maintaining stable clamping over extended periods. It also reduces the probability of valve movement enlarging the puncture site during the puncture process. Therefore, the structure of this invention is more flexible and has a wider range of applications in terms of valve clamping, fixation, and puncture, offering better applicability to valves in different states, improving product usability, and increasing surgical success rates.

[0073] The above description is only a partial embodiment of the present invention and does not limit the scope of protection of the present invention. Any equivalent device or equivalent process transformation made based on the content of the present invention specification and drawings, or direct or indirect application in other related technical fields, are similarly included within the patent protection scope of the present invention.

Claims

1. An artificial chordae tendineae implantation device capable of clamping and fixing a valve, comprising a proximal handle operating device (2), a distal clamping device (1), and at least one set of puncture devices (4), characterized in that, It also includes a control device linked to the clamping device (1) and a valve capture feedback device for determining whether the valve is captured correctly. The clamping device (1) includes a first clamp (111) and a second clamp (112). The control device controls the relative displacement of the first clamp (111) and the second clamp (112) through a linkage mechanism. The displacement is limited to X1 so that the clamping device (1) can clamp valves of different thicknesses. The control device includes an operable rotating part (3) located in the housing of the handle operating device (2), a rotating part connector (9) located in the clamping device (1) and connected to the rotating part (3), and a sliding part linked to the rotating part connector (9). (8) The handle operation device (2) further includes a feedback operation mechanism, which is connected to the valve capture feedback device. The valve capture feedback device includes a sliding member limiting block (13) located at the far end of the sliding member (8). The sliding member (8) has a groove (81) adapted to the sliding member limiting block. The sliding member limiting block (13) has a first state and a second state. When the sliding member limiting block (13) is in the first state, the sliding member limiting block (13) can pass through the groove (81) of the sliding member (8). When the sliding member limiting block (13) is in the second state, the sliding member (8) will be stuck by the sliding member limiting block (13).

2. The artificial chordae tendineae implantation device capable of clamping and fixing valves according to claim 1, characterized in that, It also includes a clamping control (15) connected to the first chuck (111), the sliding member (8) is connected to the clamping control (15), and the sliding member (8) controls the relative position of the first chuck (111) and the second chuck (112) through the clamping control (15).

3. The artificial chordae tendineae implantation device for clamping and fixing valves according to claim 2, characterized in that, The rotating component (3) has a rotating shaft located within the handle operating device (2), and the rotating component (3) makes circular motion around the rotating shaft as the central axis.

4. The artificial chordae tendineae implantation device for clamping and fixing valves according to claim 3, characterized in that, The handle operating device (2) includes an upper shell assembly (21) and a lower shell assembly. The upper shell assembly (21) and the lower shell assembly form a first groove (38) and a second groove (39). The rotating member (3) has a third groove (35) and a fourth protrusion (37). The rotating member (3) has an initial position state. When the rotating member (3) is in the initial position state, the third groove (35) is in an interference fit with the first groove (38), and the fourth protrusion (37) is in an interference fit with the second groove (39).

5. The artificial chordae tendineae implantation device for clamping and fixing valves according to claim 4, characterized in that, The rotating component (3) has a connecting hole (36), one end of the rotating component connector (9) is connected to the connecting hole (36), and the other end is connected to the sliding component (8).

6. The artificial chordae tendineae implantation device for clamping and fixing valves according to claim 5, characterized in that, The horizontal displacement of the connecting hole (36) is set to X2, and the horizontal displacement of the rotating connector (9) is X3, where X2 = X3.

7. The artificial chordae tendineae implantation device for clamping and fixing valves according to claim 6, characterized in that, The slider (8) has a horizontal sliding displacement set to X4, where X3 = X4 = X1.

8. The artificial chordae tendineae implantation device for clamping and fixing valves according to any one of claims 4 to 7, characterized in that, It also includes an elastic member (23), which is located near the end of the slider (8). When the slider (8) moves to the near end, the slider (8) compresses the elastic member (23). The compression displacement is set to X5, where X5 = X1.

9. The artificial chordae tendineae implantation device for clamping and fixing valves according to claim 8, characterized in that, The rotating component (3) is an elastic component. The rotating component (3) has a reset state. When the rotating component (3) is in the reset state, the rotating component (3) is in an interference fit with the upper shell assembly (21). At this time, the rotating component (3) is in the initial position state.

10. The artificial chordae tendineae implantation device for clamping and fixing valves according to claim 9, characterized in that, The feedback operation mechanism includes a detection button (6), and the clamping control component (15) is connected to a rotation limiting structure (25) and a torsion spring structure. The torsion spring structure is pre-tightened and limited to the lower shell assembly, and the torsion spring structure is connected to the detection button (6).

11. The artificial chordae tendineae implantation device for clamping and fixing valves according to claim 10, characterized in that, The detection button (6) has an initial pointing direction (612) and a feedback pointing direction (611). When the detection button (6) is in the initial pointing direction (612), the sliding limit block (13) is in the first state. When the probe button (6) is in the feedback pointing direction (611), the clamping control member (15) rotates by a corresponding angle, so that the sliding member limiting block (13) is in the second state.

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