Tricuspid valve repair device and system with stable clamping force

Abstract

The present invention provides a tricuspid valve repair device and system with a stable clamping force. The tricuspid valve repair device includes a base, at least two clamp arms, and a drive assembly. The at least two clamp arms are rotatably connected to the base. The drive assembly includes a drive member movably connected to the base and at least two sliding members slidably connected to the clamp arms in a one-to-one correspondence. Each sliding member is rotatably connected to the drive member. The drive member moves axially relative to the base to drive each sliding member to slide relative to the clamp arm to which it is connected, thereby driving the at least two clamp arms to open or close relative to the base. The tricuspid valve repair device provided by the present invention has a clamp arm that is opened and closed by a sliding member. When the clamp arm clamps the leaflet, the sliding member slides relative to the clamp arm, shortening the force arm of the leaflet tension acting on the clamp arm, thereby reducing the torque on the clamp arm, preventing the clamp arm from fatigue deformation due to prolonged leaflet tension, and ensuring that the device provides a stable clamping force, thereby maintaining a better clamping effect.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a tricuspid valve repair device and system with stable clamping force. Background Art

[0002] See also Figure 1 The tricuspid valve 1 is a one-way valve located between the right atrium 2 and the right ventricle 3 of the heart. A healthy tricuspid valve 1 controls the flow of blood from the right atrium 2 to the right ventricle 3, while preventing blood from flowing from the right ventricle 3 to the right atrium 2. The tricuspid valve 1 consists of three leaflets: the anterior leaflet, the posterior leaflet, and the septal leaflet. Under normal circumstances, when the right ventricle 3 contracts, the three leaflets of the tricuspid valve 1 can completely close, preventing blood from flowing from the right ventricle 3 to the right atrium 2. Figure 2 When tricuspid valve 1 develops a disease that causes tricuspid regurgitation (TR), it is primarily caused by primary valve degeneration (e.g., endocarditis, rheumatic disease, carcinoid tumor, congenital disease, medication, intracardiac wire perforation, or other causes), or more commonly, by dilation of the tricuspid annulus, secondary to right atrial and / or right ventricular dilation. Tricuspid regurgitation can cause blood to flow back from the right ventricle to the right atrium, triggering a series of pathophysiological changes known as "tricuspid regurgitation."

[0003] Transcatheter tricuspid regurgitation repair technology refers to the use of a tricuspid valve repair device to clamp the anterior and septal leaflets of the tricuspid valve (near the anterior-septal junction), and if necessary, the anterior and posterior leaflets to reduce or eliminate the leaflet gap to treat tricuspid regurgitation. Figure 3 and Figure 4 In the prior art, the two clamps 501 of the tricuspid valve repair device 5 are fixed to the base 502 in a mating manner and driven to rotate and open by a connecting rod 503 that is rotatably connected to the clamps 501. The connection point between the clamps 501 and the connecting rod 503 does not move relative to the entire device. After clamping the leaflets, the clamps 501 will be subjected to the tension of the leaflets. The lever arm L0 is the length from the connection point between the clamps 501 and the connecting rod 503 to the end of the clamps 501. The tension of the leaflets is applied to the clamps 501 with a constant lever arm L0 and generates a large torque on the clamps 501. As a result, the clamps 501 that clamp the leaflets for a long time are easily deformed under fatigue, and the clamping force or clamping effect of the tricuspid valve repair device 5 cannot be guaranteed, resulting in tricuspid regurgitation. Summary of the Invention

[0004] In order to solve the above technical problems, the present invention provides a tricuspid valve repair device and a tricuspid valve repair system with stable clamping force. The tricuspid valve repair device is subjected to a smaller torque when clamping the leaflets and is not easily deformed. It can still provide a stable clamping force after clamping the leaflets for a long time, thereby maintaining a better clamping effect.

[0005] The present invention provides a tricuspid valve repair device with a stable clamping force, the tricuspid valve repair device includes a base, at least two clamp arms and a drive assembly, the at least two clamp arms are rotatably connected to the base, the drive assembly includes a drive member movably connected to the base and at least two sliding members slidably connected to the clamp arms in a one-to-one correspondence, each sliding member is rotatably connected to the driving member, the driving member moves axially relative to the base to drive each sliding member to slide relative to the clamp arm to which it is correspondingly connected, thereby driving the at least two clamp arms to open or close relative to the base.

[0006] The present invention also provides a tricuspid valve repair system, which includes the above-mentioned tricuspid valve repair device and conveying device. The conveying device includes a core shaft and a pushing shaft. The core shaft can be movably mounted in the pushing shaft. The pushing shaft is detachably connected to the base. The core shaft is detachably connected to the driving member.

[0007] The tricuspid valve repair device provided by the present invention has a clamp arm whose opening and closing is driven by a sliding part. After the clamp arm clamps the valve leaflet, the force arm of the valve leaflet tension acting on the clamp arm is the length from the sliding part to the end of the clamp arm. Since the sliding part slides relative to the clamp arm when the clamp arm is closed, the force arm is shortened, thereby reducing the torque applied to the clamp arm in the clamped state, preventing the clamp arm from fatigue deformation due to long-term pressure from the valve leaflet, and ensuring that the tricuspid valve repair device can provide a stable clamping force, thereby maintaining a better clamping effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following briefly introduces the drawings required for use in the implementation. Obviously, the drawings described below are some implementations of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0009] Figure 1 This is a schematic diagram of the tricuspid valve in its normal state.

[0010] Figure 2 This is a schematic diagram of a diseased tricuspid valve.

[0011] Figure 3 This is a schematic diagram of a tricuspid valve repair device in the prior art for treating tricuspid valve regurgitation.

[0012] Figure 4 yes Figure 3 Schematic diagram of the structure of the tricuspid valve repair device.

[0013] Figure 5 It is a schematic diagram of the three-dimensional structure of the tricuspid valve repair device provided by the first embodiment of the present invention when it is in an open state.

[0014] Figure 6 yes Figure 5 Front view of the mid-tricuspid valve repair device.

[0015] Figure 7 yes Figure 5 Side view of the mid-tricuspid valve repair device.

[0016] Figure 8 yes Figure 5 Schematic diagram of the three-dimensional structure of the tricuspid valve repair device in a closed state.

[0017] Figure 9 yes Figure 8 Front view of the mid-tricuspid valve repair device.

[0018] Figure 10 yes Figure 8 Side view of the mid-tricuspid valve repair device.

[0019] Figure 11 yes Figure 5 A schematic diagram of the three-dimensional structure after one of the clamp arms is assembled with a sliding member and a driving member.

[0020] Figure 12 yes Figure 11 Schematic diagram of the three-dimensional structure of the middle clamp arm.

[0021] Figure 13 yes Figure 12 A schematic three-dimensional structural diagram of another embodiment of the middle clamp arm.

[0022] Figure 14 yes Figure 11 Schematic diagram of the three-dimensional structure of the sliding part.

[0023] Figure 15 yes Figure 14 Side view of the middle slide.

[0024] Figure 16 yes Figure 11 Schematic diagram of the three-dimensional structure of the middle drive component.

[0025] Figure 17 yes Figure 5 Cross-sectional view of the assembled middle drive unit and base.

[0026] Figure 18 yes Figure 5 Schematic diagram of the three-dimensional structure of the middle base.

[0027] Figure 19 yes Figure 18 Cross-sectional view of the base.

[0028] Figure 20 yes Figure 5Cross-section view of the assembly of the middle caliper arm and the base through the shaft.

[0029] Figure 21 yes Figure 20 Schematic diagram of the three-dimensional structure of the transfer shaft.

[0030] Figure 22 yes Figure 5 Schematic diagram of the three-dimensional structure after the middle base and the gripping part are assembled.

[0031] Figure 23 yes Figure 22 Front view of the assembled middle base and gripping piece.

[0032] Figure 24 yes Figure 22 Schematic diagram of the three-dimensional structure of the middle gripping member.

[0033] Figure 25 yes Figure 24 Schematic diagram of the three-dimensional structure when the middle gripping member and the control member are in coordinated use.

[0034] Figure 26 It is a schematic diagram of the three-dimensional structure of the tricuspid valve repair system provided by the first embodiment of the present invention.

[0035] Figure 27 yes Figure 26 A cross-sectional view of the conveying device, base and drive shaft in one of the usage states.

[0036] Figure 28 yes Figure 26 A cross-sectional view of another usage state of the conveying device, base and drive shaft part.

[0037] Figures 29 to 32 This is a schematic diagram of the use process of the tricuspid valve repair system provided by the first embodiment of the present invention.

[0038] Figure 33 3D is a schematic diagram of the three-dimensional structure of the tricuspid valve repair device provided by the second embodiment of the present invention when it is in a closed state.

[0039] Figure 34 yes Figure 33 Schematic diagram of the three-dimensional structure of the sliding part.

[0040] Figure 35 3D is a schematic diagram of the three-dimensional structure of the tricuspid valve repair device provided by the third embodiment of the present invention when it is in an open state.

[0041] Figure 36 yes Figure 35 Schematic diagram of the three-dimensional structure of the middle base.

[0042] Figure 37 yes Figure 36Cross-sectional view of the base.

[0043] Figure 38 Yes Figure 36 A cross-sectional view of the middle base, drive shaft, and unlocking member in coordinated use.

[0044] Figure 39 3D is a schematic diagram of the three-dimensional structure of the tricuspid valve repair device provided by the fourth embodiment of the present invention when it is in an open state.

[0045] Figure 40 yes Figure 39 Schematic diagram of the three-dimensional structure of the tricuspid valve repair device in a closed state.

[0046] Figure 41 yes Figure 39 Schematic diagram of the three-dimensional structure of the middle base.

[0047] Figure 42 yes Figure 41 Cross-sectional view of the base. DETAILED DESCRIPTION

[0048] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0049] In addition, the following descriptions of the embodiments refer to the accompanying drawings to illustrate specific embodiments in which the present invention may be implemented. Directional terms used in the present invention, such as "upper," "lower," "front," "back," "left," "right," "inner," "outer," and "side," are used solely with reference to the directions in the accompanying drawings. Therefore, the use of directional terms is intended to better and more clearly illustrate and understand the present invention, and is not intended to indicate or imply that the device or component referred to must have a specific orientation, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limiting the present invention.

[0050] Definition of Direction: For clarity, the end closest to the operator during surgery will be referred to as the "proximal end," and the end farther from the operator will be referred to as the "distal end." Axial refers to the direction parallel to the line connecting the distal and proximal centers of the medical device. Radial refers to the direction perpendicular to the axial direction. The above definitions are for convenience only and are not to be construed as limitations on the present invention. "Connection between component A and component B" means that component A is directly connected to component B, or that component A is indirectly connected to component B through another component.

[0051] First embodiment

[0052] Please also refer to Figure 5 、 Figure 26 、 Figure 29 and Figure 32 The first embodiment of the present invention provides a tricuspid valve repair device 100 with a stable clamping force, which can be used for edge-to-edge repair of the tricuspid valve 1 to treat tricuspid regurgitation. The first embodiment of the present invention also provides a tricuspid valve repair system, in which the tricuspid valve repair device 100 is detachably connected to a delivery device 50 of the tricuspid valve repair system (such as a threaded connection, a snap connection, etc.), and the delivery device 50 can push the tricuspid valve repair device 100 into the heart through a catheter or intervene in the heart through the apex. This embodiment uses a transcatheter approach to push the tricuspid valve repair device 100 into the heart.

[0053] The proximal end of the tricuspid valve repair device 100 is releasably connected to the delivery device 50. The operator pushes the tricuspid valve repair device 100 to the patient's tricuspid valve 1, and then remotely operates the tricuspid valve repair device 100 to clamp two leaflets of the tricuspid valve 1 together, for example, clamp the anterior leaflet and the septal leaflet together, and / or clamp the anterior leaflet and the posterior leaflet together. When two leaflets of the tricuspid valve 1 are apposed edge to edge, the operator releases the connection between the delivery device 50 and the tricuspid valve repair device 100, so that the tricuspid valve repair device 100 is detached from the distal end of the delivery device 50 and remains in the patient's body as an implant to maintain the apposition position of the leaflets together and alleviate the patient's tricuspid valve regurgitation.

[0054] See also Figure 5 and Figure 11 The tricuspid valve repair device 100 includes a base 10, at least two forceps arms 20, and a drive assembly 30. The at least two forceps arms 20 are rotatably connected to the base 10. The drive assembly 30 includes a drive member 31 movably connected to the base 10 and at least two sliding members 32 slidably connected to the forceps arms 20 in a one-to-one correspondence. Each sliding member 32 is rotatably connected to the drive member 31. The drive member 31 moves axially relative to the base 10 to drive each sliding member 32 to slide relative to its corresponding forceps arm 20, thereby driving the at least two forceps arms 20 to open or close relative to the base 10.

[0055] The opening and closing of the clamp arm 20 of the above-mentioned tricuspid valve repair device 100 is driven by the sliding member 32. After the clamp arm 20 clamps the leaflet, the force arm L1 of the leaflet tension acting on the clamp arm 20 is the length from the sliding member 32 to the end of the clamp arm 20. Since the sliding member 32 slides relative to the clamp arm 20 when the clamp arm 20 is closed, the force arm L1 is shortened, thereby reducing the torque applied to the clamp arm 20 in the clamped state, preventing the clamp arm 20 from fatigue deformation due to long-term leaflet tension, and ensuring that the tricuspid valve repair device 100 can provide a stable clamping force, thereby maintaining a better clamping effect.

[0056] Understandable, see Figures 6 to 10 Driven by the driver 31, the slider 32 slides relative to the corresponding clamp arm 20, driving the clamp arm 20 to rotate. That is, the slider 32 realizes motion conversion, converting the axial movement of the driver 31 into the rotation of the clamp arm 20. The sliding of the slider 32 changes its relative position with the clamp arm 20. When the driver 31 moves axially toward the proximal end relative to the base 10, the slider 32 gradually approaches the middle of the clamp arm 20, driving the clamp arm 20 to rotate and close relative to the base 10; when the driver 31 moves axially toward the distal end relative to the base 10, the slider 32 gradually moves away from the middle of the clamp arm 20 toward the distal end of the clamp arm 20, driving the clamp arm 20 to rotate and open relative to the base 10.

[0057] During the process of the tricuspid valve repair device 100 clamping the leaflets, the pulling force of the driving member 31 is converted into a clamping force of the clamp arm 20. The smaller the closing angle of the clamp arm 20, the greater the required clamping force. When the closing angle of the clamp arm 20 relative to the base 10 is smaller, the sliding member 32 is closer to the middle of the clamp arm 20. This greatly shortens the force arm L1 acting on the clamp arm 20 by the leaflet pulling force when the clamp arm 20 is in the closed state, thereby reducing the torque applied to the clamp arm 20 in the clamped state, preventing fatigue deformation of the clamp arm 20 due to prolonged leaflet pulling force, effectively improving the deformation resistance of the tricuspid valve repair device 100, and ensuring that the tricuspid valve repair device 100 can still provide a stable clamping force under long-term clamping, maintaining an optimal clamping effect.

[0058] The tricuspid valve repair device 100 of the present invention utilizes a driving member 31 to drive a sliding member 32 to slide, thereby driving the forceps arm 20 to rotate. Compared to a connecting rod drive, the device has a simpler structure and is lighter overall, reducing the drag on the tricuspid valve leaflets by the device 100. Because the leaflets of the tricuspid valve 1 are thinner, the device 100 is less susceptible to fatigue. The lighter weight of the device 100 ensures fatigue resistance after repair, improving the long-term effects of the repair. Therefore, the device is particularly suitable for repairing the tricuspid valve 1.

[0059] Preferably, the entire tricuspid valve repair device 100 is made of biocompatible materials, including but not limited to stainless steel, pure titanium, nickel-titanium, cobalt-chromium alloy, etc., to ensure safety after implantation. Furthermore, an active drug may be applied to the inner surface of the forceps arm 20 that contacts the valve leaflets to promote the growth and coverage of endothelial cells on the inner surface of the forceps arm.

[0060] In this embodiment, there are two arms 20 and two sliders 32, and the opening angle range of the two arms 20 is 0-170 degrees. The driving member 31 moves axially relative to the base 10 toward the proximal end of the base 10, driving each slider 32 to slide along its corresponding arm 20 toward the proximal end of the arm 20, gradually approaching the middle of the arm 20, thereby closing the two arms 20 relative to the base 10 to clamp the valve leaflets. It is understood that in other embodiments, the number of arms 20 and sliders 32 may also be three, four, or other numbers greater than two.

[0061] See also Figure 5 and Figures 11 to 12 Each clamp arm 20 is provided with a slide rail or slide groove 211 along its length direction, and the sliding member 32 slides on the slide rail or slide groove 211 along the length direction of the clamp arm 20, so that each sliding member 32 can slide relative to the corresponding clamp arm 20 to which it is connected.

[0062] In this embodiment, each clamp arm 20 includes a clamping piece 21 and two opposing connecting pieces 22. The two connecting pieces 22 are fixedly connected to opposite sides of the clamping piece 21. The distal end of each connecting piece 22 is pivotally connected to the base 10, and the clamping piece 21 is used to clamp the valve leaflet. Specifically, the clamping piece 21 has the aforementioned slide groove 211 defined at one end near the base 10. The slide groove 211 extends from the distal end of the clamping piece 21 to the proximal end of the clamping piece 21 to the middle of the clamping piece 21, that is, the slide groove 211 extends along the length of the clamp arm 20. The slider 32 slidably engages with the slide groove 211, allowing each slider 32 to slide relative to the corresponding clamp arm 20 along the length of the clamp arm 20.

[0063] In other embodiments, the inner side of each connecting piece 22 is provided with the above-mentioned slide rail (not shown in the figure) at one end close to the base 10, and the slide rail extends from the distal end of the connecting piece 22 to the proximal end of the connecting piece 22 to the middle part, that is, the slide rail extends along the length direction of the clamp arm 20, and the sliding member 32 slides in cooperation with the slide rail, so that each sliding member 32 can slide along the length direction of the clamp arm 20 relative to the corresponding clamp arm 20 to which it is connected.

[0064] When the driver 31 moves toward the proximal end of the base 10, it drives the clamp arms 20 to close via the sliders 32. At this point, each slider 32 moves along the chute 211 toward the proximal end of the clamp arm 20, gradually approaching the middle of the clamp arm 20. The slider 32 drives the corresponding clamp arm 20 to rotate relative to the base 10, causing the clamp arm 20 to rotate relative to the base 10 toward the base 10, i.e., the clamp arm 20 closes relative to the base 10 to clamp the leaflet. When the clamp arm 20 is in the initial closed state of delivery, the slider 32 is at the proximal end of the chute 211. When the driver 31 moves toward the distal end of the base 10, the driver 31 drives the slider 32 along the chute 211 toward the distal end of the clamp arm 20. At this point, the clamp arm 20 rotates relative to the base 10, and the clamp arm 20 gradually opens. When the slider 32 moves to the distal end of the chute 211, the clamp arm 20 is fully opened.

[0065] Optionally, the width of the clamping sheet 21 ranges from 3mm to 8mm. In this way, it is possible to avoid the situation where the width of the clamping sheet 21 is too small, resulting in the area of the clamping sheet 21 clamping the leaflet being too small, which is easy to damage the leaflet, and it is possible to avoid the situation where the width of the clamping sheet 21 is too large, resulting in the area of the clamping sheet 21 clamping the leaflet being too large, which is easy to cause the leaflet to cause stenosis after being clamped. Preferably, the width of the clamping sheet 21 ranges from 4mm to 6mm. Optionally, the length of the clamping sheet 21 ranges from 5mm to 14mm. In this way, it is possible to avoid the situation where the length of the clamping sheet 21 is too short, resulting in the situation where the clamping sheet 21 cannot guarantee the apposition edges of the leaflet after clamping the leaflet, and cannot effectively reduce regurgitation; and it is possible to avoid the situation where the length of the clamping sheet 21 is too long, resulting in the leaflet being over-clamped, which on the one hand will cause the leaflet to be over-clamped, and on the other hand will easily cause leaflet perforation. Preferably, the length of the clamping sheet 21 ranges from 6mm to 12mm.

[0066] Further, see Figure 13 The side of the connecting piece 22 facing away from the clamping piece 21 is provided with a plurality of grip-enhancing structures, such as ridges, barbs, bosses, or other irregularly distributed protrusions 223, along its length. When the forceps arm 20 captures the valve leaflet, the protrusions 223 increase the friction between the forceps arm 20 and the leaflet. Alternatively, the forceps arm 20 may be covered with a gasket or coating made of a biocompatible material with a high coefficient of friction to enhance the grip of the forceps arm 20 on the leaflet.

[0067] In other embodiments, the clamp arm 20 may be provided with a first magnetic body, and correspondingly, a second magnetic body corresponding to the first magnetic body is provided on the base 10, so that the mutual magnetic attraction between the two can achieve the purpose of enhancing the clamping force of the clamp arm 20 on the leaflet.

[0068] See also Figure 5 、 Figure 11 and Figures 14 and 15The sliding member 32 includes a rotating portion 321 and at least one sliding portion 322 connected to the rotating portion 321. The rotating portion 321 is rotationally connected to the driving member 31 and is accommodated in the sliding groove 211. The sliding portion 322 is slidably connected to the clamping piece 21. In this embodiment, there are two sliding portions 322, which are disposed on opposite sides of the rotating portion 321. The sliding portions 322 on both sides are slidably connected to the clamping piece 21, providing a more stable connection.

[0069] Specifically, each sliding portion 322 includes a first limiting portion 3221 and a second limiting portion 3222. A sliding groove 3223 is defined between the first limiting portion 3221 and the second limiting portion 3222. Portions of the clamping piece 21 located on either side of the sliding groove 211 are slidably disposed in the sliding groove 3223, thereby slidably connecting the slider 32 to the clamp arm 20. When the driving member 31 moves axially relative to the base 10 toward the proximal end of the base 10, the driving member 31 drives each slider 32 to slide along the sliding groove 211 toward the proximal end of the corresponding clamp arm 20. Simultaneously, constrained by the first limiting portion 3221 and the second limiting portion 3222 of each slider 32, the slider 32 drives the corresponding clamp arm 20 to rotate relative to the base 10 toward the base 10, thereby closing the clamp arm 20 relative to the base 10 to clamp the valve leaflet. Furthermore, in this embodiment, the first and second limiting portions 3221, 3222 are both block-shaped, and their contact surfaces with the clamping piece 21 are flat, facilitating the sliding of the slider 32 relative to the clamp arm 20. It is understood that in other embodiments, the number of sliding portions 322 may be 1, 3, 4, or other positive integers that are at least 1. In the present invention, the terms "first," "second," etc., are merely for ease of description and should not be construed as limitations of the present invention.

[0070] See also Figure 5 and Figures 14 to 16 The driving member 31 includes a driving shaft 311 and a transmission portion 312 connected to the driving shaft 311. The driving shaft 311 is axially movable and extends through the base 10. The transmission portion 312 is rotatably connected to the sliding member 32. In this way, the axial movement of the driving shaft 311 relative to the base 10 causes the sliding member 32 to rotate relative to the transmission portion 312, and at the same time, causes the sliding member 32 to slide relative to the clamp arm 20, thereby changing the relative position of the two.

[0071] Specifically, the transmission portion 312 includes at least two transmission rods 3121 that are rotatably connected to the slider 32 in a one-to-one manner. The at least two transmission rods 3121 are fixedly connected to the drive shaft 311 and disposed around the drive shaft 311. The rotating portion 321 of the slider 32 is rotatably connected to the transmission rods 3121 in a one-to-one manner. The number of transmission rods 3121 corresponds to the number of sliders 32 and the number of caliper arms 20. In this embodiment, there are two transmission rods 3121. The rotating portion 321 of the slider 32 is provided with a connecting groove 3211, in which the transmission rods 3121 are positioned. The slider 32 is provided with a first rotation hole 3212 extending through the rotating portion 321, and a second rotation hole 3122 extending through the transmission rod 3121. A pin (not shown) passes through the first rotation hole 3212 and the second rotation hole 3122, thereby rotatably connecting the slider 32 to the transmission rod 3121. When the driving member 31 moves axially, it drives the rotating portion 321 of the sliding member 32 to move, so that the sliding portion 322 of the sliding member 32 slides along the corresponding tongs arm 20 and drives the tongs arm 20 to rotate relative to the base 10. It is understood that in other embodiments, the rotating portion 321 and the transmission rod 3121 can be rotatably connected via other hinged members.

[0072] It is understood that the two transmission rods 3121 of the transmission portion 312 are fixedly connected to the drive shaft 311 and are disposed on opposite sides of the drive shaft 311. The two transmission rods 3121 are coplanar with the drive shaft 311, making the overall shape of the driver 31 relatively flat. Because the driver 31 is an overall flat structure, it occupies a small space. When the two forceps 20 of the tricuspid valve repair device 100 clamp two leaflets of the tricuspid valve 1, the driver 31 located below the tricuspid valve 1 will not affect the movement of the chordae tendineae and the other leaflet. Therefore, the tricuspid valve repair device 100 of this embodiment of the present invention is particularly suitable for repairing the tricuspid valve 1.

[0073] See also Figure 5 and Figures 17 to 19 The base 10 is provided with a guide channel 11 extending axially therethrough. The base 10 includes a first base body 12 and a second base body 13. The proximal end of the second base body 13 is connected to the distal end of the first base body 12. The clamp arm 20 is rotatably connected to the second base body 13. The drive shaft 311 is axially disposed through the second base body 13 and the first base body 12. It will be understood that the first base body 12 and the second base body 13 have a connecting axial through-hole, forming the guide channel 11 for the axial movement of the drive shaft 311. The drive shaft 311 is axially disposed through the second base body 13 and the first base body 12, that is, the drive shaft 311 is disposed in the guide channel 11.

[0074] The base 10 is provided with a resilient engaging portion 121, which includes a locking end 1211 that is angled toward the interior of the guide channel 11. The outer circumference of the drive shaft 311 is provided with at least one locking groove 3111. When the drive shaft 311 is axially movable through the guide channel 11, the locking end 1211 engages the locking groove 3111 to lock the drive shaft in the guide channel 11. Thus, the engagement between the locking end 1211 of the engaging portion 121 and the locking groove 3111 locks the drive shaft 311 to the base 10, thereby locking the opening angle of the caliper arm 20. In this embodiment, the engaging portion 121 is provided on the peripheral wall of the first base body 12. When the drive shaft 311 moves along the guide channel 11 so that the clamp arms 20 clamp the leaflets, the locking end 1211 of the clamping portion 121 is clamped into the clamping groove 3111 of the drive shaft 311 to lock the position of the drive shaft 311 in the guide channel 111, thereby locking the angle between the two clamp arms 20, so that the clamp arms 20 can stably clamp the leaflets. The locking method of this embodiment simplifies the operation and ensures the locking effect. This locking principle will not cause locking failure due to wear. In addition, the base 10 and the drive shaft 311 adopt a locking method in which the locking end 1211 is clamped into the clamping groove 3111, which makes the structure of the tricuspid valve repair device 100 simpler, reduces the overall weight, and further reduces the pulling force exerted by the tricuspid valve repair device 100 on the leaflets.

[0075] The first base 12 can be a cylinder, and the second base 13 can be a rectangular block. The engaging portion 121 is a spring with an elastic memory function, which is arranged on the peripheral wall of the cylinder. When the clamp arm 20 clamps the valve leaflet, the locking end 1211 is clamped into the clamping groove 3111 of the drive shaft 311. The tension exerted by the valve leaflet on the clamp arm 20 is transmitted to the drive shaft 311, causing the drive shaft 311 to move toward the distal end. At this time, the locking end 1211 of the engaging portion 121 is subjected to a distal extrusion force under the action of the clamping groove 3111 of the drive shaft 311, causing the locking end 1211 to move toward the center of the drive shaft 311. The greater the tension exerted by the valve leaflet on the drive shaft 311, the tighter the locking portion 121 and the drive shaft 311 are locked. This solves the problem of locking failure that is prone to occur in the prior art and ensures that the clamp arm 20 can stably clamp the valve leaflet.

[0076] Optionally, the spring piece can be single-stage or multi-stage. Preferably, the spring piece is two-stage. Optionally, the number of single-stage spring pieces on the same circumferential surface of the circumferential wall of the first base body 12 can be one or more. Preferably, the number of single-stage spring pieces on the same circumferential surface of the circumferential wall of the first base body 12 is two. Optionally, the outer circumferential surface of the drive shaft 311 is provided with multiple circles of grooves 3111 along the axial direction, and the gap between the grooves 3111 ranges from 0.03mm to 0.20mm. In this way, it is avoided that the gap between the grooves 3111 is too small, resulting in the strength stability of the grooves 3111 being too low; and it is avoided that the gap between the grooves 3111 is too large, resulting in the locking end 1211 of the clamping portion 121 being locked in different levels of grooves 3111, which is not conducive to ensuring the clamping effect. For example, if the gap between the slots 3111 is too large, when the locking end 1211 of the engaging portion 121 is locked in the second-stage slot 3111, the opening angle of the clamp arm 20 is 10 degrees; when the locking end 1211 is locked in the third-stage slot 3111, the opening angle of the clamp arm 20 becomes 20 degrees, and the clamping effect between 10 and 20 degrees (e.g., 15 degrees) cannot be achieved. Preferably, the axial gap between the slots 3111 ranges from 0.08 mm to 0.12 mm.

[0077] See also Figure 5 、 Figure 18 and Figures 20 to 21 In the first embodiment, there are two tongs arms 20, and the drive assembly 30 further includes two spaced-apart rotating shafts 33. Each tongs arm 20 is rotatably connected to the second base 13 of the base 10 via two rotating shafts 33 on either side. The axes of the two rotating shafts 33 are perpendicular to the axis of the drive shaft 311. Thus, the two rotating shafts 33 connect the tongs arms 20 to the base 10, allowing the tongs arms 20 to rotate open and close relative to the base 10. A gap is provided between the two rotating shafts 33 to prevent interference with the drive shaft 311.

[0078] Specifically, the distal ends of the two connecting pieces 22 of each caliper arm 20 are provided with connecting holes 221 extending through opposite surfaces thereof. The second base body 13 includes a first end wall 131 and a second end wall 132 disposed opposite each other, a first side wall 133 and a second side wall 134 connecting the first and second end walls 131, 132, and a top wall 135 and a bottom wall 136 connecting the first and second end walls 131, 132, 133, and 134. The distal end of the first base body 12 is connected to the top wall 135. The first and second end walls 131, 132 serve as support surfaces for the caliper arms 20, supporting them. These support surfaces are parallel to the axial direction of the guide channel 11, ensuring parallelism between the caliper arms 20 during opening and closing. A through hole 137 is provided in the second base body 13, extending perpendicularly to the axial direction and extending through the first and second end walls 131, 132. The rotating shaft 33 includes a first end 331 and a second end 332. The first end 331 of each rotating shaft 33 passes through the connection hole 221 of the connecting piece 22 on one side of the two caliper arms 20 and is installed in the through hole 137. The second end 332 of each rotating shaft 33 is fixedly connected to the outer connecting piece 22, so that the connecting pieces 22 on both sides of each caliper arm 20 are rotatably connected to the second base body 13 about the two rotating shafts 33 as the rotation center. In other words, each caliper arm 20 is rotatably connected to the second base body 13 about the two rotating shafts 33 as the rotation center. In this case, each rotating shaft 33 is installed in the through hole 137 of the second base body 13, and the drive shaft 311 is axially movable through the base 10. The axes of the two rotating shafts 33 are perpendicular to the axis of the drive shaft 311. In this embodiment, the second end 332 of each rotating shaft 33 is fixedly connected to the outer connecting piece 22 by means including but not limited to gluing, welding, etc.

[0079] Preferably, the first end 331 of the rotating shaft 33 is provided with a chamfer 3311, i.e., a pointed feature, which facilitates the assembly of the first end 331 of the rotating shaft 33 with the through hole 137. Optionally, the outer diameter of the second end 332 of the rotating shaft 33 is not less than the inner diameter of the connecting hole 221 of the connecting piece 22. In this embodiment, the outer diameter of the second end 332 of the rotating shaft 33 is greater than the inner diameter of the connecting hole 221 of the connecting piece 22, and the contact area between the second end 332 and the connecting piece 22 is large, which facilitates the stable and reliable connection of the second end 332 of each rotating shaft 33 to the outer connecting piece 22.

[0080] See also Figure 5 and Figures 22 to 24 The tricuspid valve repair device 100 further includes a gripping member 40 disposed between the base 10 and the forceps arms 20. The gripping member 40 includes a fixing portion 41 and at least two gripping arms 42 connected to the fixing portion 41. The fixing portion 41 is fixedly connected to the second base 13. The gripping arms 42 have an elastic memory function and cooperate with the corresponding forceps arms 20 to grasp the valve leaflets. Thus, the gripping arms 42 and the forceps arms 20 jointly grasp and clamp the valve leaflets, providing good stability and facilitating the clamping of the valve leaflets.

[0081] The gripping member 40 is fixed to the base 10 by snapping together. The gripping member 40 is formed into an inverted structure that closes from the outside to the inside by heat setting, namely the fixing portion 41. Specifically, the fixing portion 41 is provided with a receiving groove 411. The second base body 13 of the base 10 is located in the receiving groove 411. The fixing portion 41 is clamped and fixed to the second base body 13 of the base 10 to prevent the two from moving relative to each other in the axial direction. The connection 43 between the fixing portion 41 and each gripping arm 42 is bent radially inward. The connection 43 can clamp the first base body 12 of the base 10, which is conducive to the stable connection between the gripping member 40 and the base 10. In addition, the fixing portion 41 can be provided with a limiting hole 412 that passes through the receiving groove 411 in the radial direction. The second base body 13 is respectively provided with a limiting member 138 on the first side wall 133 and the second side wall 134. When the second base 13 is placed in the receiving groove 411, the limiting member 138 engages the limiting hole 412, securing the second base 13 in the receiving groove 411. In other words, the fixing portion 41 is fixedly connected to the second base 13. The cooperation between the limiting hole 412 and the limiting member 138 further restricts the relative movement of the gripping member 40 and the base 10.

[0082] Further, see Figure 5 and Figures 24 to 25 The tricuspid valve repair device 100 further includes a control member 60. Each grasping arm 42 is provided with at least one adjustment hole 421 at one end away from the fixing portion 41. The control member 60 is connected to the adjustment hole 421 and is used to control the grasping arm 42 to move away from or closer to the forceps arm 20. The control member 60 can extend from the grasping arm 42 to the outside of the patient's body and is used to control the opening and closing of the grasping arm 42, thereby facilitating the grasping arm 42 to cooperate with the forceps arm 20 to grasp the valve leaflet.

[0083] In this embodiment, the control member 60 is thread-shaped and sequentially passes through the adjustment hole 421 of each gripping arm 42. When the control member 60 is moved toward the proximal end, i.e., when the control member 60 is tightened, each gripping arm 42 is pulled to rotate relative to the fixing portion 41 toward the second base 13. In other words, the gripping arm 42 moves away from the clamp arm 20. At this point, a space exists between each gripping arm 42 and the corresponding clamp arm 20, allowing the valve leaflets to enter between each gripping arm 42 and the corresponding clamp arm 20. When the control member 60 is no longer applied, each gripping arm 42 rebounds due to its elastic memory function. At this point, the gripping arm 42 moves toward the clamp arm 20, pressing the valve leaflets into the clamp arm 20. When the tricuspid valve repair device 100 is in the delivery state, the gripping arms 42 of the gripping member 40 are tightened by the control member 60 to a closed state and abut against the outer wall of the first base 12.

[0084] In this embodiment, there are two gripping arms 42, with the two gripping arms 42 corresponding one-to-one to the two clamp arms 20. In other embodiments, the number of gripping arms 42 may be three, four, or another number greater than two. Generally, the number of gripping arms 42 should be consistent with the number of clamp arms 20. In alternative embodiments, the adjustment hole 421 of each gripping arm 42 may be passed through a different control member 60, and each gripping arm 42 may be moved away from or closer to the corresponding clamp arm 20 by controlling the different control members 60, which is also within the scope of protection of the present invention.

[0085] The maximum angle between each gripping arm 42 and the drive shaft 311 is no less than the maximum angle between its corresponding clamp arm 20 and the drive shaft 311. This ensures a certain clamping force between the clamp arm 20 and the gripping arm 42 to clamp the leaflet located therebetween. In this embodiment, the opening and closing angles of the two clamp arms 20 relative to the base 10 range from 0° to 170°, i.e., the maximum angle between each clamp arm 20 and the drive shaft 311 is 85°. The opening and closing angles of the two gripping arms 42 relative to the fixed portion 41 range from 0° to 200°, i.e., the maximum angle between each gripping arm 42 and the drive shaft 311 is 100°. The maximum angle between each gripping arm 42 and the drive shaft 311 is greater than the maximum angle between its corresponding clamp arm 20 and the drive shaft 311.

[0086] Each grasping arm 42 may be provided with at least one process hole (not shown) to reduce the overall weight of the grasping arm 42. This not only helps to improve the elasticity of the grasping arm 42, but also facilitates the endothelial cell coverage after the tricuspid valve repair device 100 is implanted in the human body. Each grasping arm 42 may also be provided with a covering material covering the edge of the grasping arm 42 to prevent the grasping arm 42 from damaging the valve leaflets when clamping the valve leaflets.

[0087] See also Figure 24 Each gripping arm 42 is provided with barbs 422 on opposite sides thereof, facing toward the forceps arm 20. Each barb 422 is deflected at the end away from the gripping arm 42, which helps to enhance the friction between the gripping arm 42 and the leaflet when clamping the leaflet, thereby facilitating the gripping arm 42 to capture the leaflet. Furthermore, each barb 422 is smooth at the end away from the gripping arm 42, preventing damage to the leaflet when the gripping arm 42 is clamping the leaflet.

[0088] See also Figure 5 and Figures 26 to 28The first embodiment of the present invention further provides a tricuspid valve repair system, which includes the above-mentioned tricuspid valve repair device 100 and a delivery device 50. The delivery device 50 includes a core shaft 51 and a push shaft 52. The core shaft 51 is movably mounted on the push shaft 52. The push shaft 52 is detachably connected to the base 10, and the core shaft 51 is detachably connected to the drive member 31. In this way, the base 10 can be controlled by the push shaft 52, and then the drive member 31 can be operated to move axially through the core shaft 51, thereby driving the opening or closing of the forceps arm 20.

[0089] Specifically, in this embodiment, the base 10 and the push shaft 52 are detachably connected via a snap-fit mechanism. The conveying device 50 further includes a liner 53 that is sheathed between the core shaft 51 and the push shaft 52. A first "S"-shaped snap 122 is provided at the proximal end of the first base 12 of the base 10, and a second snap 521 is provided at the distal end of the push shaft 52, which mates with the first snap 122. The first snap 122 engages the second snap 521. Moving the liner 53 to a position where the two snaps engage, the push shaft 52 is connected to the first base 12, i.e., the push shaft 52 is connected to the base 10. Furthermore, the liner 53 can be used to abut against the engaging portion 121 of the base 10, causing the locking end 1211 of the engaging portion 121 to deflect away from the guide channel 11, thereby preventing the drive shaft 311 from interfering with its movement within the guide channel 11. Of course, in other embodiments, the base 10 and the push shaft 52 can be detachably connected via a threaded connection or other snap-fit mechanism.

[0090] The drive shaft 311 is detachably connected to the core shaft 51 via a threaded connection. The proximal end of the drive shaft 311 is provided with external threads 3112, while the distal end of the core shaft 51 is provided with internal threads 511 that mate with these external threads 3112. The distal end of the core shaft 51 passes through the guide channel 11 of the base 10 and is threadedly engaged with the proximal end of the drive shaft 311, thereby connecting the core shaft 51 to the drive shaft 311. At this point, pushing or pulling the core shaft 51 axially drives the drive shaft 311 to move axially.

[0091] Please also refer to Figures 25 to 32 The following uses a transcatheter cardiac interventional tricuspid valve 1 edge-to-edge repair surgery as an example to illustrate the use process and working principle of the tricuspid valve repair system provided by the first embodiment of the present invention:

[0092] S1. Please refer to Figure 26 、 Figure 27 and Figure 29The delivery device 50 is connected to the tricuspid valve repair device 100, so that the push shaft 52 is connected to the first seat body 12 of the base 10 and the core shaft 51 is screwed to the drive shaft 311. At this time, the liner 53 abuts the engaging portion 121, causing the locking end 1211 of the engaging portion 121 to deflect away from the guide channel 11. The drive shaft 311 can be moved axially by pushing and pulling the core shaft 51 axially. In the delivery state, the tricuspid valve repair device 100 is in a retracted state, that is, a closed state. The delivery device 50 and the tricuspid valve repair device 100 connected thereto are pushed from the right atrium 2 through the tricuspid valve 1 to the right ventricle 3 through a guiding device such as an adjustable sheath (not shown).

[0093] S2, please refer to Figures 25 to 27 and Figure 30 , push the core shaft 51 axially toward the distal end, so that the two clamp arms 20 of the tricuspid valve repair device 100 move away from each other. At this time, the tricuspid valve repair device 100 is in the open state. Pull the control member 60 toward the proximal end, so that the grasping arm 42 rotates in the direction away from the corresponding clamp arm 20. At this time, there is a space between the clamp arm 20 and the corresponding grasping arm 42. Move the tricuspid valve repair device 100 until two leaflets of the tricuspid valve 1 (such as the anterior leaflet and the septal leaflet) are respectively positioned between the two grasping arms 42 and their corresponding clamp arms 20. No longer apply force to the control member 60, so that the grasping arms 42 rebound and rotate in the direction close to the corresponding clamp arms 20, so that the two grasping arms 42 and their corresponding clamp arms 20 respectively clamp two leaflets of the tricuspid valve 1.

[0094] S3, please refer to Figure 26 、 Figure 28 and Figure 31 The core shaft 51 is pulled proximally, causing the two clamp arms 20 to deflect toward the base 10. This means that the two clamp arms 20 of the tricuspid valve repair device 100 tend to close, causing the tricuspid valve repair device 100 to clamp the valve leaflets and repair the diseased tricuspid valve 1. At this time, the liner 53 is pulled proximally so that it no longer abuts the engaging portion 121. The locking end 1211 of the engaging portion 121 engages the engaging groove 3111, locking the position of the drive shaft 311 relative to the base 10. The tricuspid valve repair device 100 remains in the state of clamping the valve leaflets.

[0095] S4. Please refer to Figure 26 、 Figure 28 and Figure 32 , withdraw the liner 53 toward the proximal end to leave the docking position between the push shaft 52 and the base 10, so that the push shaft 52 is separated from the base 10, and rotate the core shaft 51 to separate the core shaft 51 from the drive shaft 311; at this time, the delivery device 50 and the tricuspid valve repair device 100 are in a separated state, and the delivery device 50 can be withdrawn, leaving the tricuspid valve repair device 100 with the clamped leaflets at the tricuspid valve 1.

[0096] Second embodiment

[0097] Please also refer to Figure 5 and Figures 33 to 34 The tricuspid valve repair device 100b provided in the second embodiment of the present invention has a similar structure to the tricuspid valve repair device 100 provided in the first embodiment. The difference between the two is that the sliding member 32b in the second embodiment has a different structure from the sliding member 32 in the first embodiment. Specifically, in the second embodiment, the first limiting portion 3221b and the second limiting portion 3222b in each sliding portion 322b are both cylindrical, and the contact surface between the first limiting portion 3221b and the second limiting portion 3222b and the clamping piece 21b is a cylindrical surface with a small contact area, which is conducive to reducing the friction generated between the sliding member 32b and the clamping piece 21b during the sliding process, and is conducive to the smooth sliding of the sliding member 32b along the length direction of the clamping piece 21b. The other structures are the same as those in the first embodiment, so they are not repeated here.

[0098] Third embodiment

[0099] Please also refer to Figure 5 and Figures 35 to 38 The tricuspid valve repair device 100c provided in the third embodiment of the present invention has a similar structure to the tricuspid valve repair device 100 provided in the first embodiment. The difference between the two is that the engaging portion 121c of the base 10c in the third embodiment has a different structure than the engaging portion 121 of the base 10 in the first embodiment. Specifically, in the third embodiment, the tricuspid valve repair device 100c further includes an unlocking member 70. An unlocking portion 1212c is provided on a side of the engaging portion 121c away from the guide channel 11c. When the locking end 1211c of the engaging portion 121c engages with the locking slot 3111c of the drive shaft 311c, the unlocking member 70 engages with the unlocking portion 1212c. The unlocking member 70, through the unlocking portion 1212c, pulls the locking end 1211c away from the guide channel 11c, thereby disengaging the locking end 1211c from the locking slot 3111c of the drive shaft 311c. The unlocking member 70 can extend from the unlocking portion 1212c to outside the patient's body to control the engagement between the locking end 1211c of the engaging portion 121c and the engaging groove 3111c of the driving shaft 311c, thereby facilitating the locking and unlocking between the base 10c and the driving shaft 311c.

[0100] Specifically, the unlocking member 70 is in the shape of a thread, and the base 10c is provided with at least one engaging portion 121c, each engaging portion 121c is provided with an unlocking portion 1212c, and the unlocking portion 1212c is provided with a through hole 1213c. The unlocking member 70 passes through the through hole 1213c and is connected to the unlocking portion 1212c. Pulling the unlocking member 70 toward the proximal end can deflect the locking end 1211c of the engaging portion 121c in a direction away from the guide channel 11c. At this time, the drive shaft 311c and the base 10c are in an unlocked state. In this embodiment, the base 10c is provided with two axially symmetrical engaging portions 121c, and two unlocking members 70 are passed through the through-holes 1213c of each unlocking portion 1212c, one for each other. Pulling each unlocking member 70 toward the proximal end causes the locking end 1211c of each engaging portion 121c to deflect away from the guide channel 11c, causing the locking end 1211c to disengage from the slot 3111c of the drive shaft 311c. At this point, the drive shaft 311c is unlocked in the position of the guide channel 11c, that is, the drive shaft 311c can move axially. Under the control of the unlocking member 70, the drive shaft 311c and the base 10c can be repeatedly locked and unlocked, which is beneficial for confirming the clamping effect and improving the success rate of the operation. In other embodiments, the number of engaging portions 121c can also be 3, 4, 5, or other positive integers greater than 2. In a modified embodiment, the same unlocking member 70 sequentially passes through the through hole 1213c of each unlocking portion 1212c, and by pulling the unlocking member 70, the locking end 1211c of each engaging portion 121c is deflected in a direction away from the guide channel 11c, which is also within the protection scope of the present invention.

[0101] Furthermore, the base 10c is provided with a through hole 137c extending radially therethrough. The two arms 20c of the tricuspid valve repair device 100c rotate relative to the base 10c about the through hole 137c to open or close. The specific connection method and operating principle have been described in the first embodiment and will not be repeated here. The axis of the through hole 1213c of each unlocking portion 1212c is perpendicular to the axis of the through hole 137c. That is, the axial plane of the two unlocking portions 1212c coincides with or is parallel to the axial plane of the through hole 137c, thereby preventing the unlocking portions 1212c from interfering with the opening and closing of the arms 20c. The remaining structure of the tricuspid valve repair device 100c in the third embodiment is the same as that of the first embodiment and will not be repeated here.

[0102] The tricuspid valve repair device 100c provided in the third embodiment and the tricuspid valve repair device 100 provided in the first embodiment are both pushed into the heart through a delivery device (not shown in the figure) in a transcatheter manner. The tricuspid valve repair systems provided by the two embodiments have similar structures. The specific difference is that: compared with the tricuspid valve repair system provided in the first embodiment, since the tricuspid valve repair device 100c has added an unlocking portion 1212c and an unlocking member 70, the tricuspid valve repair system provided in the third embodiment can eliminate the liner of the delivery device, reduce the complexity of the structure, and can support the docking position of the push shaft of the delivery device and the base 10c through the core shaft of the delivery device.

[0103] Fourth embodiment

[0104] Please also refer to Figure 26 and Figures 39 to 42 The tricuspid valve repair device 100d provided in the fourth embodiment of the present invention is similar in structure to the tricuspid valve repair device 100 provided in the first embodiment. The difference between the two is that the structure of the base 10d in the fourth embodiment is different from that of the base 10 in the first embodiment, and the surgical path is also different. The tricuspid valve repair device 100d in the fourth embodiment enters the heart through the transapical approach.

[0105] Specifically, in the fourth embodiment, the base 10d of the tricuspid valve repair device 100d includes a frame 11d, a first base 12d connected to the proximal end of the frame 11d, and a second base 13d connected to the distal end of the frame 11d. The forceps arm 20d is rotatably connected to the second base 13d, and the drive shaft 311d is axially disposed through the first base 12d, the frame 11d, and the second base 13d. It will be understood that the first base 12d and the second base 13d are separate and connected by the frame 11d. The first base body 12d is provided with a first passage 123d axially extending through the first base body 12d and the frame 11d. The second base body 13d is provided with a second passage 133d axially extending through the second base body 13d. The axes of the first and second passages 123d and 133d coincide with each other. The first passage 123d, the frame 11d, and the second passage 133d form a guide passage for the axial movement of a drive shaft 311d. The drive shaft 311d is movably disposed within the first passage 123d, the frame 11d, and the second passage 133d. When the drive shaft 311d moves proximally along the axial directions of the first passage 123d, the frame 11d, and the second passage 133d, the two clamp arms 20d move away from each other and open. When the drive shaft 311d moves distally along the axial directions of the first passage 123d, the frame 11d, and the second passage 133d, the two clamp arms 20d move toward each other and close. The locking and unlocking principles between the driving shaft 311d and the base 10d are the same as those in the first embodiment and will not be described in detail.

[0106] See also Figures 39 to 42 The second base 13d includes a first connecting portion 131d and a second connecting portion 132d. The first connecting portion 131d is located within the frame 11d. The clamp arm 20d is rotatably connected to the first connecting portion 131d. The distal end of the frame 11d is connected to the second connecting portion 132d. Specifically, the first connecting portion 131d includes two first connecting walls 1311d axially opposed to each other, two second connecting walls 1312d connecting the two first connecting walls 1311d and opposing each other, and two third connecting walls 1313d connecting the two first connecting walls 1311d and the two second connecting walls 1312d and opposing each other. The second connecting portion 132d is columnar. The proximal end of the second connecting portion 132d is fixedly connected to the first connecting wall 1311d near the distal end of the first connecting portion 131d. The second connecting portion 132d is mounted on the distal end of the frame 11d, thereby fixing the second base 13d to the frame 11d. Moreover, the first connecting portion 131d is axially provided with a first through hole penetrating the two first connecting walls 1311d, and the second connecting portion 132d is axially provided with a second through hole penetrating therethrough. The first through hole is communicated with the second through hole to form the above-mentioned second channel 133d, and the driving shaft 311d can movably pass through the second base body 13d and the distal end of the frame body 11d along the second channel 133d.

[0107] Furthermore, the first connecting portion 131d of the second base 13d is further provided with a through hole 134d radially extending through the two second connecting walls 1312d. The through hole 134d is connected to the first through hole. In this embodiment, there are two caliper arms 20. Each caliper arm 20d is rotatably connected to the through hole 134d on either side via two rotating shafts (not shown), allowing the two caliper arms 20d to open or close by rotating relative to the first connecting portion 131d about the rotating shafts. The connection method and operating principle of the caliper arms 20d being rotatably connected to the through hole 134d via the rotating shafts have been described in the first embodiment and will not be repeated here. Furthermore, the two second connecting walls 1312d of the first connecting portion 131d are used to support the caliper arms 20d. Both second connecting walls 1312d are parallel to the axial direction of the guide channel, ensuring parallelism during the opening and closing of the caliper arms 20d.

[0108] Optionally, the projection of the frame 11d perpendicular to the axial direction intersects with the projection of the forceps arm 20d perpendicular to the axial direction. That is, the plane of the frame 11d intersects with the plane of the forceps arm 20d, thereby preventing the frame 11d from interfering with the opening and closing of the forceps arm 20d. Preferably, the projection of the frame 11d perpendicular to the axial direction is perpendicular to the projection of the forceps arm 20d perpendicular to the axial direction. The other structures of the tricuspid valve repair device 100d have been described in the first embodiment and will not be repeated here.

[0109] In the tricuspid valve repair system of the fourth embodiment, the push shaft 52d of the delivery device 50d is detachably connected to the proximal end of the first base 12d, and the core shaft (not shown) is detachably connected to the proximal end of the drive shaft 311d. The specific connection method has been described in the first embodiment and will not be repeated here. The tricuspid valve repair system provided in this embodiment and the tricuspid valve repair system provided in the first embodiment have different surgical pathways, but the usage process and operating principles are the same.

[0110] It should be noted that the tricuspid valve repair device with stable clamping force provided by multiple embodiments of the present invention is suitable for edge-to-edge repair of the tricuspid valve 1 to treat tricuspid regurgitation, and is also suitable for edge-to-edge repair of the mitral valve to treat mitral regurgitation.

[0111] The above is an implementation of the embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the embodiment of the present invention. These improvements and modifications are also considered to be within the scope of protection of the present invention.

Claims

1. A tricuspid valve repair device with stable clamping force, characterized in that: include: base; at least two clamp arms, the at least two clamp arms being rotatably connected to the base; as well as A drive assembly, the drive assembly includes a drive member movably connected to the base and at least two sliding members slidably connected to the clamp arms in a one-to-one manner, each of the sliding members is rotationally connected to the drive member, and the drive member moves axially relative to the base to drive each sliding member to slide relative to the clamp arm to which it is correspondingly connected, thereby driving the at least two clamp arms to open or close relative to the base.

2. The tricuspid valve repair device according to claim 1, characterized in that: The clamp arm is provided with a slide rail or a slide groove along the length direction thereof, and the sliding member slides on the slide rail or the slide groove along the length direction of the clamp arm.

3. The tricuspid valve repair device according to claim 2, characterized in that: The clamp arm comprises a clamping piece, the sliding groove is provided on the clamping piece, and the sliding member is slidably matched with the sliding groove.

4. The tricuspid valve repair device according to claim 3, characterized in that: The sliding member includes a rotating portion and at least one sliding portion connected to the rotating portion. The rotating portion is rotatably connected to the driving member and accommodated in the sliding groove. The sliding portion is slidably connected to the clamping piece.

5. The tricuspid valve repair device according to claim 4, characterized in that: The sliding portion includes a first limiting portion and a second limiting portion. A sliding groove is provided between the first limiting portion and the second limiting portion. Parts of the clamping piece located on both sides of the sliding groove are slidably disposed in the sliding groove.

6. The tricuspid valve repair device according to claim 5, characterized in that: The first limiting portion is in a square or cylindrical shape, and the second limiting portion is in a square or cylindrical shape.

7. The tricuspid valve repair device according to claim 1, characterized in that: The driving member includes a driving shaft and a transmission part connected to the driving shaft. The driving shaft is axially movably arranged in the base, and the transmission part is rotatably connected to the sliding member.

8. The tricuspid valve repair device according to claim 7, characterized in that: The transmission part includes at least two transmission rods rotatably connected to the sliding members in a one-to-one correspondence, and at least two of the transmission rods are fixedly connected to the driving shaft and are arranged on the circumferential side of the driving shaft.

9. The tricuspid valve repair device according to claim 7, characterized in that: The base is provided with a guide channel passing through the base in the axial direction, and the base is provided with an elastic clamping part, which includes a locking end, and the locking end is inclined toward the inside of the guide channel. The outer peripheral surface of the drive shaft is provided with at least one clamping groove, and the drive shaft is axially movable and penetrates the guide channel, and the locking end is clamped into the clamping groove to lock the position of the drive shaft in the guide channel.

10. The tricuspid valve repair device according to claim 9, characterized in that: The tricuspid valve repair device also includes an unlocking piece, and an unlocking piece is provided on the side of the locking part away from the guide channel. The unlocking piece is connected to the unlocking piece, and the unlocking piece pulls the locking end to deflect in a direction away from the guide channel to disengage from the locking slot.

11. The tricuspid valve repair device according to claim 7, characterized in that: The base includes a first base and a second base, the proximal end of the second base is connected to the distal end of the first base, the clamp arm is rotatably connected to the second base, and the drive shaft is axially inserted into the second base and the first base.

12. The tricuspid valve repair device according to claim 11, characterized in that: There are two clamp arms, and the drive assembly further includes two rotating shafts arranged at intervals. The two sides of each clamp arm are rotatably connected to the second seat body through the two rotating shafts, and the axes of the two rotating shafts are perpendicular to the axis of the drive shaft.

13. The tricuspid valve repair device according to claim 11, characterized in that: The tricuspid valve repair device also includes a grasping member arranged between the base and the clamp arm, the grasping member includes a fixing portion and at least two grasping arms connected to the fixing portion, the fixing portion is fixedly connected to the second seat body, the grasping arm has an elastic memory function, and the grasping arm cooperates with the clamp arm to grasp the leaflet.

14. The tricuspid valve repair device according to claim 13, characterized in that: The tricuspid valve repair device further includes a control member, the grasping arm is provided with at least one adjustment hole, the control member is connected to the adjustment hole, and the control member is used to control the grasping arm to move away from or close to the clamp arm.

15. The tricuspid valve repair device according to claim 13, characterized in that: The maximum angle between each of the gripping arms and the driving shaft is not less than the maximum angle between the corresponding clamp arm and the driving shaft.

16. The tricuspid valve repair device according to claim 7, characterized in that: The base includes a frame, a first seat connected to the proximal end of the frame, and a second seat connected to the distal end of the frame. The clamp arm is rotatably connected to the second seat, and the drive shaft is axially inserted into the first seat, the frame, and the second seat.

17. The tricuspid valve repair device according to claim 16, characterized in that: The second base includes a first connecting portion and a second connecting portion. The first connecting portion is located in the frame. The clamp arm is rotatably connected to the first connecting portion. The distal end of the frame is connected to the second connecting portion.

18. The tricuspid valve repair device according to claim 16, characterized in that: The projection of the frame in a direction perpendicular to the axial direction is staggered with the projection of the clamp arm in a direction perpendicular to the axial direction.

19. A tricuspid valve repair system, characterized in that: include: The tricuspid valve repair device according to any one of claims 1 to 18; as well as The conveying device includes a core shaft and a pushing shaft, the core shaft is movably mounted in the pushing shaft, the pushing shaft is detachably connected to the base, and the core shaft is detachably connected to the driving member.

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