Leaflet clamping system

Abstract

The embodiment of the invention relates to the technical field of medical instruments, and discloses a valve leaflet clamping system which is provided with an elastic locking piece at least partially contained in a containing through hole and a coupling piece with the near end partially contained in the containing through hole, and the elastic locking piece is located on the outer side, perpendicular to the axis direction, of the coupling piece; the elastic locking piece can be locked with the coupling piece, the base is prevented from moving in the first direction, the unlocking wire enables the elastic locking piece to deform at least in the direction perpendicular to the axis so as to be unlocked from the coupling piece, and the base is allowed to move in the first direction. The elastic locking piece is located on the outer side, perpendicular to the axis direction, of the coupling piece, a large deformation space can be set, and therefore when the elastic locking piece and the coupling piece are mutually locked, stable coupling force can be provided; when the elastic locking piece and the coupling piece are unlocked, the unlocking wire directly acts on the elastic locking piece, and the elastic locking piece is unlocked from the coupling piece in the direction perpendicular to the axis. Therefore, the use reliability of the valve leaflet clamping system can be improved.

Description

Technical Field

[0001] Embodiments of the present invention relate to the technical field of medical devices, and particularly to a leaflet clamping system. Background Art

[0002] The main pathophysiological change of mitral regurgitation is mitral valve reflux. During left ventricular systole, blood flows from the left ventricle into the aorta and the left atrium with relatively low resistance. The regurgitant volume flowing into the left atrium can reach more than 50% of the left ventricular stroke volume, which increases the load on the left atrium and the diastolic load on the left ventricle. The transcatheter mitral valve repair system is a minimally invasive surgical solution for treating mitral regurgitation. This system can be briefly summarized as a mitral valve clamping device and a delivery device; after the delivery device delivers the mitral valve clamping device near the mitral valve, the mitral valve clamping device is controlled to clamp the anterior and posterior leaflets of the mitral valve, and then the mitral valve clamping device is released and the delivery device is withdrawn.

[0003] Generally speaking, the mitral valve clamping device includes clamping arms and clamping pieces, and both can swing around the axis of the mitral valve clamping device. By the relative swing between the clamping arms and the clamping pieces, the clamping of the edges of the mitral valve leaflets is achieved to reduce mitral regurgitation. During this process, a locking mechanism is required to lock and unlock the swing of the clamping arms.

[0004] At present, the locking mechanism of the existing mitral valve clamping device is often realized by the friction between the drive shaft and the locking piece. For example, U.S. Patent US20060020275A1 discloses a locking mechanism, in which the locking piece is inserted into the drive shaft and is set at an angle with the locking piece, and the spring applies elastic force to the locking key, so that friction is generated between the locking piece and the drive shaft to prevent the drive shaft from moving. However, the existing technical solutions have many disadvantages. For example, since the surfaces of the drive shaft and the locking piece for achieving locking are relatively smooth, the friction force is small, so the locking force is insufficient, and continuous friction will cause component wear, causing the locking mechanism to slip or lock failure. For another example, since the locking piece is set at an angle and requires a movable space to unlock, the deformation space of the spring, especially the deformation space in the axial direction, is small, which results in a small force on the locking piece by the spring, and then it is easy to cause misoperation during locking, causing the locking mechanism to fail. In addition, due to the small deformation space of the spring, the size of the external force driving the locking piece to rotate is limited. If the external force is too small, the separation between the locking piece and the drive shaft will not be smooth, and there will be scratches. If the external force is too large, the spring and even the drive wire of the drive spring will be damaged. Therefore, the operator needs a long learning time. For another example, the locking piece is unlocked from the drive shaft by controlling the swing of the locking piece through the wire harness to overcome the force of the spring on the locking piece. This requires precise assembly between the wire harness, the spring and the locking piece to avoid the wire harness failing to drive the locking piece to swing, or the locking piece sliding relative to the spring when swinging and failing to overcome the force of the spring on the locking piece, which will make the locking mechanism easy to fail. Failure of the locking mechanism will cause the mitral valve clamping device to open prematurely during transportation, or accidentally open during the process of clamping the valve leaflets, or the valve clip to fall off after implantation, resulting in surgical failure or even serious harm to the patient's life and health.

[0005] Therefore, there is an urgent need in the art for a leaflet clamping system that can solve at least one of the above problems. Summary of the invention

[0006] The purpose of the embodiments of the present invention is to provide a leaflet clamping system, which can improve the locking force of the prosthesis clamping device and prevent the prosthesis from being released prematurely due to locking failure during the delivery process.

[0007] In order to solve the above technical problems, the present invention provides a leaflet clamping system, comprising:

[0008] Leaflet clamping device and delivery device; the leaflet clamping device includes: a base having an axially disposed receiving through-hole; a clamping arm including a connecting end and a clamping end, the connecting end being rotatably connected to the base, and the clamping end being a free end; an actuating assembly including a base, a proximal end of the base being movably received in the receiving through-hole, the base further being drivingly connected to the clamping arm; a locking assembly including an elastic locking member disposed in the receiving through-hole and a coupling member disposed at the proximal end of the base, the elastic locking member being located outside the coupling member in a direction perpendicular to the axis, and the elastic locking member and the coupling member being configured such that when the elastic locking member is locked with the coupling member, the base is prevented from moving in a first direction to maintain the posture of the clamping arm, the first direction being a distal direction along the axis of the base or a proximal direction along the axis of the base; the delivery device includes: an unlocking wire removably passing through the elastic locking member for pulling the elastic locking member and causing the elastic locking member to deform at least in a direction perpendicular to the axis to unlock with the coupling member, and further the base can move in the first direction so that the clamping arm can rotate.

[0009] In an embodiment of the present invention, compared with the related art, an elastic locking member is provided at least partially received in the receiving through-hole of the base, a coupling member with a proximal part movably received in the receiving through-hole, the elastic locking member is located outside the coupling member in a direction perpendicular to the axis, and the elastic locking member can be locked with the coupling member to prevent the base from moving in a first direction. The unlocking wire is used to pull the elastic locking member and cause the elastic locking member to deform at least in a direction perpendicular to the axis to unlock with the coupling member, so that the base can move in the first direction. Since in this embodiment, the elastic locking member is located outside the coupling member in a direction perpendicular to the axis, a relatively large deformation space can be provided. Therefore, when the elastic locking member is locked with the coupling member, a relatively stable coupling force can be maintained; when the elastic locking member is unlocked from the coupling member, the unlocking wire directly acts on the elastic locking member, and the elastic locking member deforms in a direction perpendicular to the axis to unlock with the coupling member. In this way, the reliability of use of the leaflet clamping system can be improved. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] One or more embodiments are illustrated by way of example in the accompanying drawings, which illustrations do not constitute a limitation on the embodiments. Elements with the same reference numerals in the drawings are represented as similar elements, unless otherwise stated, and the drawings in the figures do not constitute a scale limitation.

[0011] Figure 1 is a schematic diagram of the cooperation between the leaflet clamping device and the delivery device in an embodiment of the present invention;

[0012] Figure 2It is a schematic structural diagram of a leaflet clamping device in an embodiment of the present invention;

[0013] Figure 3 is Figure 2 a schematic cross-sectional view of the device shown;

[0014] Figure 4 It is a schematic cross-sectional view of the leaflet clamping device in an embodiment of the present invention when locked;

[0015] Figure 5 It is a schematic structural diagram of the locking mechanism of the leaflet clamping device in an embodiment of the present invention;

[0016] Figure 6 It is a schematic structural diagram of an integrally formed elastic locking member and a capturing member of the leaflet clamping device in an embodiment of the present invention;

[0017] Figure 7 It is a schematic diagram of the cooperation between the elastic locking member and the base of the leaflet clamping device in an embodiment of the present invention;

[0018] Figure 8 It is a schematic diagram of the arrangement of the unlocking wire of the leaflet clamping device in an embodiment of the present invention;

[0019] Figure 9 It is a schematic cross-sectional view of the arrangement of the first unlocking wire and the second unlocking wire of the leaflet clamping device in an embodiment of the present invention;

[0020] Figure 10 It is a schematic diagram of the unilateral unlocking wire controlling the elastic locking member and the capturing member of the leaflet clamping device in an embodiment of the present invention;

[0021] Figure 11 It is a schematic structural diagram of the elastic locking member of the leaflet clamping device in another embodiment of the present invention;

[0022] Figure 12 is Figure 11 a schematic cross-sectional view of the elastic locking member shown;

[0023] Figure 13 It is a schematic diagram of the cooperation between the capturing member and the elastic locking member of the leaflet clamping device in another embodiment of the present invention;

[0024] Figure 14 is Figure 13 a schematic cross-sectional view of the cooperation schematic diagram shown;

[0025] Figure 15 It is a schematic structural diagram of the leaflet clamping device in another embodiment of the present invention. Detailed implementation manners

[0026] To make the objectives, technical solutions and advantages of the embodiments of the present invention clearer, the following will elaborate on each embodiment of the present invention with reference to the accompanying drawings. However, those of ordinary skill in the art can understand that in each embodiment of the present invention, many technical details are provided to help readers better understand the present application. Nevertheless, even without these technical details and various changes and modifications based on the following embodiments, the technical solutions claimed in the present application can still be implemented.

[0027] In the embodiments of the present invention, the terms "upper", "lower", "left", "right", "front", "rear", "top", "bottom", "inner", "outer", "middle", "vertical", "horizontal", "lateral", "longitudinal", etc. indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. These terms are mainly used to better describe the present invention and its embodiments, and are not intended to limit that the indicated devices, elements or components must have a specific orientation or be constructed and operated in a specific orientation.

[0028] Moreover, in addition to being used to represent the orientation or positional relationship, some of the above terms may also be used to represent other meanings. For example, the term "upper" may also be used to represent a certain attachment relationship or connection relationship in some cases. For those of ordinary skill in the art, the specific meanings of these terms in the present invention can be understood according to specific circumstances.

[0029] In addition, the terms "install", "set", "provide", "open", "connect", "couple" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral structure; it can be a mechanical connection or an electrical connection; it can be directly connected, or indirectly connected through an intermediate medium, or there can be internal communication between two devices, elements or components. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0030] In addition, the terms "first", "second", etc. are mainly used to distinguish different devices, elements or components (the specific types and structures may be the same or different), and are not intended to indicate or imply the relative importance and quantity of the indicated devices, elements or components. Unless otherwise specified, "a plurality of" means two or more.

[0031] It should be noted that in this application, "proximal", "near side" and "distal", "far side" are relative position concepts. Generally speaking, the end closer to the patient and farther from the operator is the distal end and the far side, and the end closer to the operator and farther from the patient is the proximal end and the near side. For the delivery device, during use, the end closer to the target position is the distal end, and the end closer to the operating end is the proximal end. In addition, "parallel" and "perpendicular" should not be narrowly understood as 0° or 90°, but should be understood as including a reasonable angular range with a certain floating relative to 0° or 90° on the premise of achieving the technical effect.

[0032] The present invention provides a leaflet clamping system, including: a leaflet clamping device and a delivery device. The leaflet clamping device includes: a base having an axially arranged receiving through hole; a clamping arm including a connecting end and a clamping end, the connecting end being rotatably connected to the base, and the clamping end being a free end; an actuating assembly including a base, the proximal end of the base being movably received in the receiving through hole, and the base being also drivingly connected to the clamping arm; a locking assembly including an elastic locking member disposed in the receiving through hole and a coupling member disposed at the proximal end of the base, the elastic locking member being located outside the coupling member in a direction perpendicular to the axis, and the elastic locking member and the coupling member being configured such that when the elastic locking member is locked with the coupling member, the base is blocked from moving in a first direction to maintain the posture of the clamping arm; the delivery device includes: an unlocking wire removably passing through the elastic locking member for pulling the elastic locking member and deforming the elastic locking member at least in a direction perpendicular to the axis to unlock it from the coupling member, and then the base can move in the first direction so that the clamping arm can rotate. Herein, the first direction is the direction towards the distal end along the axis of the base and the direction towards the proximal end along the axis of the base.

[0033] In the leaflet clamping system provided by the present invention, the elastic locking member disposed at least partially in the receiving through hole of the base, the coupling member movably received in the receiving through hole, the elastic locking member being located outside the coupling member in a direction perpendicular to the axis, and the elastic locking member can be locked with the coupling member to prevent the axial movement of the base, and the unlocking wire is used to pull the elastic locking member and deform the elastic locking member at least in a direction perpendicular to the axis to unlock it from the coupling member. Since in this embodiment, the elastic locking member is located outside the coupling member in a direction perpendicular to the axis, a relatively large deformation space can be provided. Therefore, when the elastic locking member is locked with the coupling member, a relatively stable coupling force can be maintained; when the elastic locking member is unlocked from the coupling member, the unlocking wire directly acts on the elastic locking member and deforms the elastic locking member at least in a direction perpendicular to the axis to unlock it from the coupling member. In this way, the use reliability of the leaflet clamping system can be improved.

[0034] The implementation details of the leaflet clamping system of the present invention are described in detail below. The following content is only provided for easy understanding of the implementation details and is not necessary for implementing the present solution.

[0035] See also Figures 1 to 15 The leaflet clamping system in one embodiment of the present invention includes: a leaflet clamping device and a conveying device. The leaflet clamping device includes: a base 100, the base 100 has an axially arranged receiving through hole 110; a clamping arm 200, the clamping arm 200 includes a connecting end 210 and a clamping end 220, the connecting end 210 is rotatably connected to the base 100, and the clamping end 220 is a free end; an actuating assembly 300, including a base 310, the proximal end of the base 310 is movably received in the receiving through hole 110, the base 310 is transmission-connected to the clamping arm 200, and when the base 310 moves axially, the clamping arm 200 is The arm 200 is driven to rotate around the base 100; the locking assembly 400 includes an elastic locking member 410 disposed in the receiving through hole 110 and a coupling member 420 disposed at the proximal end of the base 310, wherein the elastic locking member 410 is located outside the coupling member 420 in a direction perpendicular to the axis, and the elastic locking member 410 and the coupling member 420 are configured such that when the elastic locking member 410 is locked with the coupling member 420, the base 310 is prevented from moving along the first direction P1 to maintain the posture of the clamp arm 200. The conveying device includes an unlocking wire 600, which is removably passed through the elastic locking member 410 and is used to pull the elastic locking member 410 and cause the elastic locking member 410 to deform at least in a direction perpendicular to the axis to unlock with the coupling member 420, so that the base 310 can move along the first direction P1 to enable the clamp arm 200 to rotate. In this embodiment, the first direction P1 is from the axis of the base to the distal direction. Obviously, in other embodiments, the first direction P1 may also be from the axis of the base to the proximal direction.

[0036] In this embodiment, when the elastic locking member 410 and the coupling member 420 are locked with each other, the risk of the locking assembly 400 failing due to the external axial force is reduced; when the elastic locking member 410 and the coupling member 420 need to be unlocked, the unlocking wire 600 directly acts on the elastic locking member 410, causing the elastic locking member 410 to deform in a direction perpendicular to the axis to unlock the coupling member 420. In this way, the reliability of the leaflet clamping system can be improved.

[0037] In some embodiments, the leaflet clamping device can be configured such that when the elastic locking member 410 and the coupling member 420 are locked to each other, the base 310 is prevented from moving in the first direction P1, i.e., axially away from the base 100, and at the same time, the base 310 is also prevented from moving in the second direction P2 opposite to the first direction P1, i.e., axially closer to the base 100.

[0038] In this embodiment, the elastic locking member 410 includes a coupling portion, the coupling portion is a first protrusion, the first protrusion is a protrusion structure including a first abutting surface, the coupling member 420 has a plurality of second protrusions, the second protrusions are protrusion structures including second abutting surfaces, and the first abutting surface is used to abut against the second abutting surface so that when the elastic locking member 410 and the coupling member 420 are locked, the base 310 cannot move in the first direction P1. More specifically, the first abutting surface of the first protrusion can abut against the second abutting surface of the second protrusion adjacent to the first direction P1, and the first abutting surface and the second abutting surface are configured such that when the first abutting surface abuts against the second abutting surface, the force exerted by the first abutting surface on the second abutting surface balances the external force received by the second abutting surface. Obviously, the external force received by the second abutting surface here refers to the force that is not exerted by the first abutting surface on the second abutting surface. The external force received by the second abutting surface is, for example, the operating force applied by the operator to the second abutting surface through the conveying device through the base 310, or the force applied by the leaflet to the second abutting surface through the clamping arm 200 and the base 310.

[0039] Furthermore, the first protrusion further includes a third abutting surface, and the second protrusion further includes a fourth abutting surface. The third abutting surface is used to abut against the fourth abutting surface so that when the elastic locking member 410 and the coupling member 420 are locked, the base 310 cannot move in the second direction P2. More specifically, the third abutting surface of the first protrusion can abut against the fourth abutting surface of the second protrusion adjacent to the second direction P2, and the third abutting surface and the fourth abutting surface are configured such that when the third abutting surface abuts against the fourth abutting surface, the force exerted by the third abutting surface on the fourth abutting surface balances the external force received by the fourth abutting surface. The external force received by the fourth abutting surface here is similar to the external force received by the second abutting surface. In one example, the first protrusion is a protrusion structure having a first abutting surface and a third abutting surface. For example, the first protrusion is a protrusion structure with a triangular, trapezoidal, rectangular, or square cross-section. In one example, the second protrusion is a protrusion structure having a second abutting surface and a fourth abutting surface. For example, the second protrusion is a protrusion structure with a triangular, trapezoidal, rectangular, or square cross-section. In a preferred example, both the first protrusion and the second protrusion are protrusion structures with a rectangular cross-section.

[0040] Exemplarily, when the leaflet clamping device for treating mitral regurgitation is delivered transcatheter from the human vein to the left atrium, the clamping arms 200 need to be closed towards the base 100 to be in the state with the smallest cross-section for easy delivery, and the elastic locking member 410 and the coupling member 420 need to be locked with each other to prevent the accidental rotation of the clamping arms 200; when passing the leaflet clamping device through the mitral valve, the elastic locking member 410 and the coupling member 420 need to be unlocked, and the driving base 310 is axially moved to drive the clamping arms 200 to rotate and expand to determine whether the leaflet clamping device is at a proper angle relative to the mitral valve; after passing through the mitral valve and retracting the leaflet clamping device so that the leaflets fall into the space between the clamping arms 200 and the base 100, the driving base 310 is axially moved to make the clamping arms 200 close and rotate towards the base 100. When the clamping arms 200 rotate a certain angle, the elastic locking member 410 and the coupling member 420 are locked with each other, and then the state of the leaflet clamping device is judged, such as whether the anterior leaflet and posterior leaflet of the mitral valve are detached from the space between the clamping arms 200 and the base 100, whether the anterior and posterior leaflets of the mitral valve are in a proper posture in the space between the clamping arms 200 and the base 100, etc. After confirmation, the elastic locking member 410 and the coupling member 420 are unlocked, and the clamping arms 200 are continuously driven to close. After the clamping arms 200 completely clamp the leaflets, the elastic locking member 410 and the coupling member 420 are locked with each other again. Here, the first direction P1 is the proximal direction along the axis, and the second direction P2 is the distal direction along the axis. When locking, the first abutting surface of the first protrusion facing the proximal end abuts against the second abutting surface of the second protrusion located on the proximal side thereof facing the distal end, and the third abutting surface of the first protrusion facing the distal end abuts against the fourth abutting surface of the second protrusion located on the distal side thereof facing the proximal end. In this way, the base 310 cannot move towards the distal end or the proximal end.

[0041] In some other embodiments, the leaflet clamping device can be arranged such that when the elastic locking member 410 and the coupling member 420 are locked with each other, the movement of the base 310 towards the first direction P1, such as axially away from the base 100, is blocked, but the base 310 is allowed to move towards the second direction P2, such as axially close to the base 100, so that the clamping arms 200 can rotate in a single direction. Wherein, the first direction P1 and the second direction P2 are opposite.

[0042] As Figures 5 - 6As shown, in this embodiment, the elastic locking member 410 includes a coupling portion 414. The coupling portion 414 is a third protrusion, and the third protrusion is a protrusion structure including a fifth abutting surface and a first sliding surface. The coupling member 420 has a plurality of fourth protrusions, and the fourth protrusions are protrusion structures including a sixth abutting surface and a second sliding surface. The fifth abutting surface is used to abut against the sixth abutting surface, and the first sliding surface is used to slide relative to the second sliding surface. When the elastic locking member 410 and the coupling member 420 are locked, the base 310 is allowed to move in the second direction P2 and is blocked from moving in the first direction P1. More specifically, the fifth abutting surface of the third protrusion is adjacent to the sixth abutting surface of the fourth protrusion adjacent to it on the side of the second direction P2 (proximal end in this embodiment), and the fifth abutting surface and the sixth abutting surface are configured such that when the base 310 moves in the first direction P1, the fifth abutting surface abuts against the sixth abutting surface, and the force exerted by the fifth abutting surface on the sixth abutting surface balances the external force received by the sixth abutting surface. Here, the external force received by the sixth abutting surface is similar to the external force received by the second abutting surface. On the other hand, the first sliding surface of the third protrusion is adjacent to the second sliding surface of the fourth protrusion adjacent to it on the side along the first direction P1 (distal end in this embodiment). And the first sliding surface and the second sliding surface are configured such that when the base 310 moves in the second direction P2, the force exerted by the first sliding surface on the second sliding surface is less than the external force received by the second sliding surface. Here, the external force received by the second sliding surface being similar to the external force received by the second abutting surface means the force other than the force exerted by the first sliding surface on the second sliding surface, for example, the operating force applied by the operator through the base 310. Thus, when the base 310 moves toward the first direction P1, the third abutting surface of the third protrusion abuts against the fourth abutting surface of the fourth protrusion adjacent to the first direction P1, and when the base 310 moves toward the second direction P2, the first sliding surface of the third protrusion can move relative to the second sliding surface of the fourth protrusion adjacent to the second direction P2, the elastic locking member 410 deforms, and after the third protrusion and the fourth protrusion are separated, the elastic locking member 410 returns to its original state, and the first sliding surface of the third protrusion is adjacent to the second sliding surface of the next fourth protrusion.

[0043] In one example, the third protrusion is a protrusion structure with a triangular or trapezoidal cross-section. In one example, the fourth protrusion is a protrusion structure with a triangular or trapezoidal cross-section. Exemplarily, the third protrusion is a protrusion structure with a right trapezoidal cross-section and is disposed on the elastic locking member 410 through its hypotenuse. The surface corresponding to the shorter base is used as the third abutting surface, and the surface corresponding to the longer base is used as the first sliding surface. The shorter base is disposed on the elastic locking member 410 at an acute angle with the second direction P2 (i.e., greater than 0° and less than 90°). The angle between the shorter base of the right trapezoidal protrusion structure and the second direction P2 is not specifically limited and can be any angle within the range of 10° to 60°, or can be any angle within the range of 30° to 45°. Correspondingly, the fourth protrusion is a protrusion structure with an obtuse triangular cross-section, and the obtuse side (the surface where it is located is used as the second sliding surface) is disposed at an obtuse angle with the second direction P2. One of the other two sides has a surface used as the fourth abutting surface, and the other side is disposed on the connecting portion 312 described below. In this way, the coupling member 420 forms a structure similar to a one-way rack.

[0044] Please also refer to Figures 2 - 5 , in some embodiments, the actuating assembly 300 further includes a connecting rod 320. One end of the connecting rod 320 is rotatably connected to the base 310, and the other end of the connecting rod 320 is rotatably connected to the clamping arm 200, so that the base 310 is drivingly connected to the clamping arm 200.

[0045] In some embodiments, the actuating assembly 300 is configured such that when the base 310 moves along the second direction P2, the clamping arm 200 is driven to rotate and approach the base 100 through the connecting rod 320, so as to reduce the space between the clamping arm 200 and the base 100; when the base 310 moves along the first direction P1, the clamping arm 200 is driven to rotate and move away from the base 100 through the connecting rod 320, so as to increase the space between the clamping arm 200 and the base 100. Exemplarily, after the leaflet falls into the space between the clamping arm 200 and the base 100, by driving the base 310 to move along the second direction P2, the clamping arm 200 is driven to close and rotate towards the base 100. When the clamping arm 200 rotates by a certain angle, the elastic locking member 410 and the coupling member 420 are locked with each other, and then the state of the leaflet clamping device is judged, such as whether the anterior and posterior mitral valves are separated from the space between the clamping arm 200 and the base 100, whether the anterior and posterior mitral valves are in the space between the clamping arm 200 and the base 100 in a proper posture, etc. Then, the base 310 is driven to move along the second direction P2, and the clamping arm 200 is continuously driven to close, without unlocking the elastic locking member 410 and the coupling member 420 and then driving the base 310 to move along the second direction P2.

[0046] Continue to refer to Figures 2 - 5, in some embodiments, the base 310 includes a connecting portion 312 at the proximal end and a main body portion 311 at the distal end. Among them, the connecting portion 312 is movably received in the receiving through hole 110 of the base 100, and the coupling member 420 is disposed on the outer surface of the connecting portion 312. The main body portion 311 is located at the distal end of the base 100, and the connecting rod 320 is rotatably connected to the main body portion 311. In this embodiment, the distal end surface of the main body portion 311 may be a curved surface and arched toward the distal end, which is beneficial to the delivery of the leaflet clamping device inside the human body.

[0047] In one example, the base 310 is in a T shape, that is, the connecting portion 312 is arranged along the axial direction of the base 100, and the main body portion 311 is arranged along a direction perpendicular to the axis of the base 100. The connecting rod 320 is rotatably connected to the end of the main body portion 311. The other end of the connecting rod 320 is rotatably connected between the connecting end 210 and the clamping end 220 of the same-side clamping arm 200 and at a position close to the connecting end 210. Combining with the connecting end 210 of the clamping arm 200 being rotatably connected to the base 100. In this way, the actuating assembly 300, the clamping arm 200, and the base 100 form a four-bar linkage similar to a crank-slider. When the base 310 moves proximally relative to the base 100, the clamping arm 200 rotates and approaches the base 100, and vice versa.

[0048] Further, the delivery device further includes a driving wire, and the driving wire extends from the proximal end to the distal end of the delivery device and is detachably connected to the proximal end of the connecting portion 312, such as a threaded connection. Driven by the axial movement of the driving wire, the base 310 moves axially.

[0049] In one example, the coupling member 420 extends from the proximal end to the distal end of the connecting portion 312. In another example, the coupling member 420 is disposed at the proximal end of the connecting portion 312. For example, the axial length of the coupling member 420 is 30% - 80% of the axial length of the connecting portion 312. In this way, the locking function is no longer provided for the stage that does not require locking, which can reduce the processing difficulty and cost.

[0050] In an alternative embodiment, the actuating assembly 300 is configured to drive the clamping arm 200 to rotate and move away from the base 100 through the connecting rod 320 when the base 310 moves in the second direction P2, so as to increase the space between the clamping arm 200 and the base 100; when the base 310 moves in the first direction P1, drive the clamping arm 200 to rotate and approach the base 100 through the connecting rod 320, so as to reduce the space between the clamping arm 200 and the base 100. Specifically, as Figure 15As shown, the difference from the above embodiment is that the clamping arm 200 further includes an extension end, and the extension end and the clamping end 220 are located on both sides of the connection end 210. The other end of the connecting rod 320 is rotatably connected to the extension end of the clamping arm 200 on the other side. That is, after the clamping arm 200 on the other side is rotatably connected to the base 100, it continues to extend to one side of the connecting rod 320 and is rotatably connected to the connecting rod 320.

[0051] Continue to refer to Figures 5 - 7 , and Figures 11 - 14 , in some embodiments, the elastic locking member 410 further includes a fixing portion 413 and a clamping portion 411. The fixing portion 413 is used to fix the elastic locking member 410 inside the receiving through hole 110. The coupling portion 414 is disposed on the clamping portion 411. The clamping portion 411 is used to keep the coupling portion 414 locked with the coupling member 420 in a free state, and can be deformed perpendicular to the axial direction under the action of the unlocking wire 600, so that the coupling portion 414 is separated from the coupling member 420, and further the elastic locking member 410 is unlocked from the coupling member 420.

[0052] In one example, the fixing portion 413 is located at the distal end of the elastic locking member 410 and is fixed to the inner wall of the receiving through hole 110. The fixing portion 413 can be fixedly connected to the base 100 by conventional means, such as glue bonding, welding, riveting, screw fixing, etc.

[0053] In another example, the fixing portion 413 is U-shaped to accommodate the wall portion of the base 100. That is, the fixing portion 413 extends from the inner wall of the receiving through hole 110 to the distal end, and then extends back from the outside of the base 100 to the proximal end after protruding from the base 100. Preferably, the size of the space for accommodating the wall portion between the U-shaped fixing portions 413 is slightly smaller than the thickness of the wall portion, so that the fixing portion 413 is in closer contact with the inner wall of the receiving through hole 110 and the outside of the base 100. Preferably, a positioning portion 120 is provided outside the distal end of the base 100. Correspondingly, a positioning hole 413a is provided on the fixing portion 413 of the elastic locking member 410, and the positioning portion 120 and the positioning hole 413a are matched. By accommodating the wall portion of the base 100 in the fixing portion 413 and the positioning portion 120 in the positioning hole 413a, a fixing effect is achieved between the base 100 and the elastic locking member 410. For example, the positioning portion 120 is a convex block, and the cross-sectional shape of the convex block can be square, circular, elliptical or other shapes; the cross-sectional shape and size of the positioning hole 413a are the same as those of the convex block. After the wall portion of the base 100 is squeezed into the U-shaped fixing portion 413 and the convex block of the fixing portion 413 is located in the positioning hole 413a, the elastic locking member 410 cannot move relative to the base 100.

[0054] Continuing to refer Figures 5 - 7 , in some embodiments, the clamping portion 411 is elastic so that when there is no external force acting on the clamping portion 411 (i.e., in the free state), the coupling portion 414 and the coupling member 420 are kept locked, and under the action of an external force, it deforms in a direction perpendicular to the axis, so that the coupling portion 414 and the coupling member 420 are separated. In one example, the clamping portion 411 is arc-shaped, and the coupling portion 414 is disposed on a side of the clamping portion 411 close to the coupling member 420. Preferably, the elastic locking member 410 further includes an extension portion extending from the clamping portion 411 toward the proximal end. One end of the arc-shaped clamping portion 411 is connected to the fixing portion 413, and the other end may be connected to the extension portion. The arrangement of the extension portion can make the clamping portion 411 more easily deformed. When the clamping portion 411 is in the free state, the extension portion may be closely attached to the inner wall of the receiving through hole 110 ( Figure 3 as shown), or there may be a certain distance between the extension portion and the inner wall of the receiving through hole 110 ( Figure 7 as shown), to further increase the deformation space. When the arc-shaped clamping portion 411 is subjected to an external force, it can generate a deformation perpendicular to the axial direction. Further, the clamping portion 411 is made of a biocompatible material with good elasticity, such as nitinol alloy. In other embodiments, the clamping portion 411 may also adopt other shape structures that are easily deformed, such as a folded shape (such as an M shape), a spiral shape, a circular shape, etc.

[0055] Continuing to refer Figures 8 - 9 , in some embodiments, the unlocking wire 600 extends from the proximal end of the delivery device to the distal end to the base 100, enters the receiving through hole 110 and is at least partially located on a side of the clamping portion 411 close to the coupling member 420, and extends toward the proximal end of the delivery device after passing through the receiving through hole 110. Thus, when the two ends of the unlocking wire 600 are pulled from the proximal end of the delivery device, the unlocking wire 600 located on a side of the clamping portion 411 close to the coupling member 420 will exert a force on the clamping portion 411, causing the clamping portion 411 to deform in a direction perpendicular to the axis.

[0056] In one example, at least two first wire threading holes 111 are axially spaced on the side wall of the base 100, and the first wire threading holes 111 communicate with the accommodation through hole 110. At least one first wire threading hole 111 is located at the proximal end of the clamping portion 411, and one first wire threading hole 111 is located at the distal end of the clamping portion 411. For example, on one side wall of the base 100, a first wire threading hole 111 communicating with the accommodation through hole 110 is provided at the proximal end of the clamping portion 411, and on the same side wall, a first wire threading hole 111 communicating with the accommodation through hole 110 is provided at the distal end of the clamping portion 411. Preferably, the first wire threading holes 111 are provided on the positioning portion 120. The elastic locking member 410 is axially spaced with at least two second wire threading holes 412, wherein the two second wire threading holes 412 respectively communicate with the first wire threading holes 111. For example, the second wire threading hole 412 located at the proximal end of the clamping portion 411 communicates with the first wire threading hole 111 located at the proximal end of the clamping portion 411, and the second wire threading hole 412 located at the distal end of the clamping portion 411 communicates with the first wire threading hole 111 located at the distal end of the clamping portion 411. The unlocking wire 600 passes through the first wire threading hole 111 located at the proximal end of the clamping portion 411, the second wire threading hole 412 located at the proximal end of the clamping portion 411, and then enters the side of the clamping portion 411 close to the coupling member 420, and then sequentially passes through multiple second wire threading holes 412 (if any), and finally exits from the second wire threading hole 412 located at the distal end of the clamping portion 411 and the first wire threading hole 111 located at the distal end of the clamping portion 411 to the outside of the base 100, and then extends toward the proximal end of the conveying device. Thus, by pulling the unlocking wire 600, the elastic locking member 410 can be deformed in a direction perpendicular to the axial direction, thereby unlocking the elastic locking member 410 and the coupling member 420. In this embodiment, the second wire threading holes 412 are located at the proximal or distal end outside the clamping portion 411, that is, one second wire threading hole 412 is located at the extending portion, and one second wire threading hole 412 is located at the fixing portion. In other embodiments, the second wire threading holes 412 are located at the proximal or distal end on the clamping portion 411.

[0057] As Figures 8 - 9As shown, the side wall of the base 100 is provided with two first threading holes 111 at intervals along the axial direction, which are respectively provided at the proximal end and the distal end of the base 100. The elastic locking member 410 is provided with four second threading holes 412 at intervals along the axial direction. One of the four second threading holes 412 is provided at the extension portion of the elastic locking member 410, and is connected with the first threading hole 111 at the proximal end of the base 100; two are provided at the clamping portion 411; and the other is provided at the fixing portion, and is connected with the first threading hole 111 at the distal end of the base 100. That is, the two second threading holes 412 are located outside the clamping portion 411, and are respectively at the proximal end and the distal end of the clamping portion 411, and the two second threading holes 412 are located on the clamping portion 411, and are respectively at the proximal end and the distal end of the clamping portion 411. Preferably, the coupling portion 414 is disposed between two second threading holes 412 disposed on the clamping portion 411, and more preferably, disposed on the edge of one of the second threading holes 412. The unlocking wire 600 passes through the first threading hole 111 at the proximal end of the clamping portion 411 and enters the accommodating through hole 110, and after passing through the second threading hole 412 at the proximal end, is located at a side of the clamping portion 411 close to the coupling member 420, and then passes through the second threading hole 412 at the clamping portion 411 and enters a side of the clamping portion 411 away from the coupling member 420 to avoid interfering with the contact between the coupling portion 414 and the coupling member, and then passes through the other second threading hole 412 at the clamping portion 411, and the unlocking wire 600 continues to be located at a side of the clamping portion 411 close to the coupling member 420, and continues to pass through the second threading hole 412 at the distal end of the clamping portion 411 and the first threading hole 111, and then passes through the base 100 and extends to the proximal end.

[0058] It is understandable that when there are two elastic locking members 410, the other elastic locking member 410 can be symmetrically arranged with the above-mentioned elastic locking member 410 about the axis of the base 100. At this time, the coupling member 420 is two, and is symmetrically arranged on the opposite sides of the proximal end of the base 310 about the axis of the base 100. In addition, the same first threading hole 111 can be arranged on the other side wall of the base 100 opposite to the side wall provided with the first threading hole 111, and the second threading hole 412 on the second elastic locking member 410 can also be arranged with reference to the second threading hole 412 of the above-mentioned elastic locking member 410, so as to avoid the situation that the two unlocking wires 600 interfere with each other. In some examples, the two first threading holes 111 at the proximal end of the clamping portion 411 can be arranged correspondingly in the axial direction, or there can be a certain degree of stagger in the axial direction. At the same time, the two first threading holes 111 at the distal end of the clamping portion 411 can also be arranged correspondingly in the axial direction, or there can also be a certain degree of stagger in the axial direction.

[0059] The operator can pull either end of the unlocking wire 600, or pull both ends of the unlocking wire 600 simultaneously, causing the clamping portion 411 to deform, specifically, to deform in a direction away from the connecting portion 312, so that the coupling portion 414 moves away from the connecting portion 312, and further enabling the connecting portion 312 to move, so that the clamping arm 200 can be driven. It should be noted that when pulling either end of the unlocking wire 600, it is preferable to fix the other end to prevent the unlocking wire 600 from being pulled out of the leaflet clamping device during pulling.

[0060] Continuing to refer to Figures 5 - 7 and Figures 13 - 14 In some embodiments, the leaflet clamping device further includes a capturing member 230. The capturing member 230 includes a fixed end 234 and a free end 231. The fixed end 234 is fixedly connected to the base 100, and the free end 231 can swing relative to the base 100. By providing the capturing member 230, the capturing member 230 can cooperate with the clamping arm 200 to clamp the leaflet 500 more conveniently and firmly.

[0061] In one example, the fixed end 234 is fixedly connected to the fixing portion 413 of the elastic locking member 410, so that the capturing member 230 is fixedly connected to the base 100. Preferably, the two are integrally formed.

[0062] In another example, there are two capturing members 230, which are symmetrically arranged along the axial direction of the base 100. Moreover, the fixed ends 234 of the two capturing members 230 are fixedly connected to each other to form a capturing member group. Each capturing member 230 in the capturing member group cooperates with a clamping arm 200 to clamp a leaflet 500. Thus, the capturing member group is in an Ω shape and is sleeved and fixed outside the fixing portion 413. Further, the fixed end 234 is provided with a fourth wire passing hole 235, and the fourth wire passing hole 235 is communicated with the first wire passing hole 111 at the distal end of the clamping portion 411. After the unlocking wire 600 passes through the first wire passing hole 111 at the distal end of the clamping portion 411, it exits the base 100, passes through the fourth wire passing hole 235, and then extends towards the proximal end of the conveying device.

[0063] In some examples, the capture member 230 further includes a bending portion 238 located between the fixed end 234 and the free end 231. The bending portion 238 is used to connect the fixed end 234 and the free end 231 with different extending directions and provide an elastic force for the free end 231 to swing and deflect and then return to its original state. Further, a fifth wire threading hole 236 is also provided in the bending portion 238. The elastic performance of the bending portion 238 can be adjusted by the shape and size of the fifth wire threading hole 236, and the fifth wire threading hole 236 can also provide a channel for the unlocking wire 600 that extends from the distal end of the base 100 to the proximal end of the conveying device. The first wire threading hole 111 located at the proximal end of the clamping portion 411 is arranged at a position far from the bending portion 238, so as to avoid interference of the capture member 230 on the unlocking wire 600 entering the base 100.

[0064] In some other embodiments, the unlocking wire 600 passes through the first wire threading hole 111 at the distal end of the clamping portion 411, that is, after passing through the base 100, it continues to be movably connected to the capture member 230 and then extends toward the proximal end. In this way, the operator can control both the elastic locking member 410 and the swing of the capture member 230 through the unlocking wire 600.

[0065] Further, there are two capture members 230, which are symmetrically arranged about the axis of the base 100. The unlocking wire 600 includes the first unlocking wire 610 and the second unlocking wire 620. The first unlocking wire 610 extends from the proximal end on one side of the conveying device to the distal end to the base 100, enters the accommodation through hole 110 and is at least partially located on one side of one clamping portion 411 close to one coupling member 420. After leaving the accommodation through hole 110, it is movably connected to one capture member 230 and then extends toward the proximal end of the conveying device. The second unlocking wire 620 extends from the proximal end on the symmetrically opposite side of the conveying device to the distal end to the base 100, enters the accommodation through hole 110 and is at least partially located on one side of the other clamping portion 411 close to the other coupling member 420. After leaving the accommodation through hole 110, it is movably connected to the other capture member 230 and then extends toward the proximal end of the conveying device.

[0066] In one example, after passing through the first wire threading hole 111 at the distal end of the clamping portion 411, that is, after passing through the base 100, the unlocking wire 600 is interpenetrated with the capture member 230 or an accessory provided on the capture member 230 to facilitate controlling the swing of the capture member 230. There is no particular limitation on the specific implementation manner in this example.

[0067] For example, as Figures 8 - 10As shown, the accessory is a connecting ring 232, which is arranged at the free end, for example, by bundling or tying. After the unlocking wire 600 passes through the fourth through-hole 237, it passes through the connecting ring 232 and then extends towards the proximal end of the conveying device.

[0068] For another example, the capturing member 230 is provided with a plurality of third wire-passing holes 233 at intervals along its extending direction. After the unlocking wire 600 passes through the base 100, it sequentially passes through the plurality of third wire-passing holes 233 and then extends towards the proximal end. It can be understood that the connecting ring 232 and the third wire-passing holes 233 can be used in combination, that is, the connecting ring 232 and the third wire-passing holes 233 are simultaneously arranged on the capturing member 230.

[0069] The movable connection mode between the unlocking wire 600 and the capturing member 230 can also refer to the connection modes shown in FIGS. 17-19 and the corresponding description content in Chinese Patent Document CN115501001A. These connection modes are incorporated into this application as a part of this application. Obviously, here the unlocking wire 600 can pass through the base 100, pass through the fifth wire-passing hole 236 and then interpenetrate with the capturing member 230 or the accessory on the capturing member 230.

[0070] It can be understood that generally, in order to control the state of the free end 231, a control wire is separately arranged at the free end 231 to drive the free end 231 to swing relative to the base 100 through the control wire. At this time, the operator not only needs to unlock through the unlocking wire 600, but also needs to control the free end 231 by manipulating the control wire, which increases the workload of the operator and improves the operation difficulty. Through the technical setting of this embodiment, the unlocking wire 600 can also be used as the control wire for controlling the free end 231, simplifying the structure of the leaflet clamping device, reducing the number of components that the operator needs to operate, and reducing the operation difficulty of the leaflet clamping device.

[0071] In the present invention, the base 100, the capturing member 230, the elastic locking member 410, the clamping arm 200, the base 310, the connecting rod, etc. are made of biocompatible materials, such as pure titanium, titanium alloy, cobalt-chromium alloy, etc. Among them, the clamping portion 411 and the unlocking wire 600 can be made of a metal material with good elasticity, such as nickel-titanium alloy.

[0072] Please refer to again Figure 1 、 Figure 5 and Figure 8, the delivery device further includes a delivery handle, a sheath 700, a drive wire, and an unlocking wire 600; the proximal ends of the unlocking wire 600, the drive wire, and the proximal end of the sheath 700 are all disposed on the delivery handle, the distal end of the drive wire passes through the sheath 700 and is detachably connected to the proximal end of the base 310 of the leaflet clamping device to drive the clamping arms 200 to rotate, the unlocking wire 600 extends from the proximal end to the distal end, passes through the elastic locking member 410, and then extends toward the delivery handle, and the sheath 700 is detachably connected to the base 100.

[0073] Specifically, a threaded section 422 is provided at the proximal end of the connecting portion 312 for threaded connection with the drive wire. The operator can control the drive wire through the delivery handle, and then drive the base 310 to move proximally or distally by the drive wire. The sheath 700 is detachably connected to the base 100 for delivering the leaflet clamping device to the target position and separating from the base 100 after the leaflet clamping device clamps the leaflets 500 to be withdrawn from the human body. Both the first unlocking wire 610 and the second unlocking wire 620 extend from the delivery handle at the proximal end of the system, pass through the sheath 700, pass through the elastic locking member 410, and then extend through the sheath 700 to the delivery handle. Preferably, after passing through the elastic locking member 410, the first unlocking wire 610 and the second unlocking wire 620 are movably connected to the capture member 230 and then extend through the sheath 700 to the delivery handle. In this way, it is convenient for the operator to control the unlocking of the leaflet clamping device and the capture member 230 through the first unlocking wire 610 and the second unlocking wire 620.

[0074] When transporting the leaflet clamping device into the human body through the delivery device, it is necessary to drive the drive wire to move proximally, so that the two clamping arms 200 are completely closed, and the clamping arms 200 press the capture member 230 to approach the base 100, making the overall contour of the leaflet clamping device the smallest for easy transportation in the human body. At this time, it is necessary to release the first unlocking wire 610 and the second unlocking wire 620, so that the elastic locking member 410 and the coupling member 420 are locked, that is, the connecting portion 312 is locked.

[0075] When it is necessary to deploy the leaflet clamping device to clamp the leaflets 500, pull the first unlocking wire 610 and the second unlocking wire 620 to unlock the elastic locking member 410 and the coupling member 420, and move the connecting portion 312 distally through the drive wire (for example Figure 3It moves in the direction shown by P2 in the figure. At this time, the main body portion 311 also moves towards the distal end, thereby driving the two link rods 320 to drive the two clamping arms 200 to swing towards the distal end, so that the two clamping arms 200 open; at the same time, due to pulling the first unlocking wire 610 and the second unlocking wire 620, the free ends 231 of the two catching members 230 swing towards the proximal end. At this time, the free ends 231 of the two catching members 230 and the two clamping arms 200 are separated from each other one by one to increase the clamping space formed between the catching member 230 and the clamping arm 200.

[0076] When it is necessary to clamp the valve leaf 500 after the valve leaf 500 enters the clamping space, the connecting portion 312 is driven to move towards the proximal end through the driving wire. The main body portion 311 drives the two link rods 320 to drive the two clamping arms 200 to swing towards the proximal end, and then the first unlocking wire 610 and the second unlocking wire 620 are released, so that the elastic locking member 410 and the coupling member 420 are locked, that is, the connecting portion 312 is locked, and at the same time, the two catching members 230 return to their original states under their own elastic forces. In this way, the clamping arm 200 cooperates with the catching member 230 to clamp the valve leaf 500.

[0077] In addition, when fine-tuning the catching member 230, the unlocking wire corresponding to this side can be pulled. Due to the locking of the coupling member 420 by multiple elastic locking members 410, when one unlocking wire unlocks the locking of the coupling member 420 by the elastic locking member 410 on this side because the catching member 230 needs to be adjusted, since the elastic locking members 410 on other sides still lock the coupling member 420, the connecting portion 312 will not be unlocked, and the clamping arm 200 will not swing undesirably.

[0078] Optionally, the valve leaf 500 in this embodiment can be a native valve leaf of the mitral valve, a native valve leaf of the tricuspid valve, or other native valve leaves, and the present invention does not make specific limitations on this.

[0079] The valve leaf clamping system provided by the embodiment of the present invention has been introduced in detail above. Specific examples are used in this article to elaborate on the principle and implementation manner of the present invention. The descriptions of the above embodiments are only used to help understand the idea of the present invention, and there will be changes in the specific implementation manner and application scope. In summary, the content of this specification should not be construed as a limitation to the present invention.

Claims

1. A leaflet clamping system, characterized in that: include: leaflet clipping devices and delivery devices; The leaflet clamping device comprises: A base, wherein the base has an axially arranged receiving through hole; A clamping arm, the clamping arm comprising a connecting end and a clamping end, the connecting end is rotatably connected to the base, and the clamping end is a free end; An actuating assembly, comprising a base, a proximal end of the base being movably accommodated in the accommodation through hole, and the base being also transmission-connected to the clamp arm; A locking assembly, comprising an elastic locking member disposed in the accommodating through hole and a coupling member disposed at the proximal end of the base, wherein the elastic locking member is located outside the coupling member perpendicular to the axial direction, and the elastic locking member and the coupling member are configured such that when the elastic locking member is locked with the coupling member, the base is prevented from moving along a first direction to maintain the posture of the clamp arm, wherein the first direction is along the axis of the base toward the distal end, or along the axis of the base toward the proximal end; The conveying device comprises: An unlocking wire is removably passed through the elastic locking member, and is used to pull the elastic locking member and cause the elastic locking member to deform at least in a direction perpendicular to the axis to unlock the coupling member, so that the base can move along a first direction to allow the clamping arm to rotate.

2. The leaflet clamping system according to claim 1, characterized in that: The elastic locking member includes a coupling portion, which is a first protrusion, the first protrusion includes a first abutment surface, the coupling member has a plurality of second protrusions, the second protrusions include a second abutment surface, and the first abutment surface is used to abut against the second abutment surface so that when the elastic locking member is locked with the coupling member, the base is prevented from moving along the first direction.

3. The leaflet clamping system according to claim 2, characterized in that: The first protrusion also includes a third abutment surface, and the second protrusion also includes a fourth abutment surface, and the third abutment surface is used to abut against the fourth abutment surface so that when the elastic locking member is locked with the coupling member, the base is prevented from moving along a second direction, and the second direction is a direction opposite to the first direction.

4. The leaflet clamping system according to claim 1, characterized in that: The elastic locking member includes a coupling portion, which is a third protrusion. The third protrusion includes a fifth abutting surface and a first sliding surface. The coupling member has a plurality of fourth protrusions. The fourth protrusion includes a sixth abutting surface and a second sliding surface. The fifth abutting surface is used to abut against the sixth abutting surface. The first sliding surface is used to slide relative to the second sliding surface, so that when the elastic locking member and the coupling member are locked, the base is allowed to move in the second direction and is prevented from moving in the first direction.

5. The leaflet clamping system according to claim 4, characterized in that: The fifth abutting surface of the third protrusion is adjacent to the sixth abutting surface of the fourth protrusion located on one side of the third protrusion in the second direction and adjacent thereto, and the fifth abutting surface and the sixth abutting surface are configured such that when the base moves along the first direction, the fifth abutting surface abuts against the sixth abutting surface, and the force applied by the fifth abutting surface to the sixth abutting surface is balanced with the external force applied to the sixth abutting surface; The first sliding surface of the third protrusion is adjacent to the second sliding surface of the fourth protrusion located on one side of the third protrusion along the first direction, and the first sliding surface and the second sliding surface are configured so that when the base moves along the second direction, the force applied by the first sliding surface to the second sliding surface is smaller than the external force applied to the second sliding surface.

6. The leaflet clamping system according to claim 1, characterized in that: The actuating assembly further comprises a connecting rod, one end of which is rotatably connected to the base, and the other end of which is rotatably connected to the clamping arm, so that the base is transmission-connected to the clamping arm.

7. The leaflet clamping system according to claim 6, characterized in that: The clamp arm comprises a connecting end and a clamping end, the connecting end is rotatably connected to the base, the clamping end is a free end, the base comprises a connecting portion located at a proximal end and a main body located at a distal end, the connecting portion is movably accommodated in the accommodating through hole of the base, the main body is located at the distal end of the base, one end of the connecting rod is rotatably connected to the end of the main body, and the other end of the connecting rod is rotatably connected between the connecting end and the clamping end of the clamp arm on the same side; or, The clamp arm includes an extension end, a connecting end and a clamping end, the connecting end is rotatably connected to the base, the clamping end is a free end, the extension end and the clamping end are located on both sides of the connecting end, the base includes a connecting portion located at a proximal end and a main body located at a distal end, the connecting portion is movably accommodated in the accommodating through hole of the base, the main body is located at the distal end of the base, one end of the connecting rod is rotatably connected to the end of the main body, and the other end of the connecting rod is rotatably connected to the extension end of the clamp arm on the other side.

8. The leaflet clamping system according to any one of claims 2 to 5, characterized in that: The elastic locking piece also includes a fixing portion and a clamping portion, wherein the fixing portion is used to fix the elastic locking piece in the accommodating through hole, and the coupling portion is arranged on the clamping portion, and the clamping portion is used to keep the coupling portion and the coupling piece locked in a free state, and can be deformed perpendicular to the axial direction under the action of the unlocking wire to separate the coupling portion from the coupling piece, thereby unlocking the elastic locking piece from the coupling piece.

9. The leaflet clamping system according to claim 8, characterized in that: The unlocking wire extends from the proximal end of the conveying device to the distal end to the base, and after entering the accommodating through hole, at least part of it is located on a side of the clamping portion close to the coupling member, and after passing through the accommodating through hole, it extends proximally to the proximal end of the conveying device.

10. The leaflet clamping system according to claim 9, characterized in that: The side wall of the base is provided with at least two first threading holes spaced apart in the axial direction and respectively connected to the accommodating through hole, the elastic locking member is provided with at least two second threading holes spaced apart in the axial direction, and at least two second threading holes are respectively connected to the first threading hole, at least one of the first threading hole and at least one of the second threading holes are located at the proximal end of the clamping portion, and at least one of the first threading hole and at least one of the second threading holes are located at the distal end of the clamping portion; The unlocking wire passes through the first wire threading hole located at the proximal end of the clamping portion and then enters the accommodating through hole, and then passes through the second wire threading hole located at the proximal end of the clamping portion and then enters the side of the clamping portion close to the coupling member, and finally passes through the second wire threading hole located at the distal end of the clamping portion and the first wire threading hole to the outside of the base, and then extends toward the proximal end of the conveying device.

11. The leaflet clamping system according to claim 10, characterized in that: The side wall of the base is provided with two first threading holes spaced apart in the axial direction and respectively connected to the accommodating through hole, the elastic locking member is provided with four second threading holes spaced apart in the axial direction, and the two second threading holes are respectively connected to the first threading hole, and one of the first threading holes and the two second threading holes are located at the proximal end of the clamping portion, and the other first threading hole and the other two second threading holes are located at the distal end of the clamping portion; The unlocking wire passes through the first wire threading hole located at the proximal end of the clamping part and then enters the accommodating through hole. After passing through the second wire threading hole located at the proximal end of the clamping part, it enters the side of the clamping part close to the coupling member, and then enters the side of the clamping part away from the coupling member through another second wire threading hole, and then enters the side of the clamping part close to the coupling member through another second wire threading hole, and finally passes through the second wire threading hole located at the distal end of the clamping part and the first wire threading hole to the outside of the base, and then extends toward the proximal end of the conveying device.

12. The leaflet clamping system according to claim 10, characterized in that: The elastic locking member further comprises an extension portion extending from the clamping portion toward the proximal end, one end of the clamping portion is connected to the fixing portion, and the other end is connected to the extension portion, a second threading hole located at the proximal end of the clamping portion is located in the extension portion, and the clamping portion is in a free state; The extending portion is in close contact with the inner wall of the accommodating through hole, or a distance is provided between the extending portion and the inner wall of the accommodating through hole.

13. The leaflet clamping system according to claim 10, characterized in that: The fixing portion extends from the inner wall of the accommodating through hole to the distal end, and then extends from the outer side of the base to the proximal end after extending out of the base. A positioning portion is provided on the outside of the distal end of the base, and a positioning hole is provided on the fixing portion. The wall of the base is accommodated in the fixing portion, and the positioning portion is accommodated in the positioning hole, so that the elastic locking piece is fixed to the base, and the first threading hole located at the distal end of the clamping portion is provided on the positioning portion.

14. The leaflet clamping system according to claim 10, characterized in that: The leaflet clamping device further comprises a capture member, wherein the capture member comprises a fixed end and a free end, wherein the fixed end is fixedly connected to the base, and the free end can swing relative to the base. After passing through the first threading hole at the far end of the clamping portion, the unlocking wire continues to be movably connected to the capturing member, so that the unlocking wire controls the swing of the capturing member.

15. The leaflet clamping system according to claim 14, characterized in that: After passing through the first threading hole at the distal end of the clamping portion, the unlocking wire interpenetrates with the capture member or an accessory disposed on the capture member.

16. The leaflet clamping system according to claim 14, characterized in that: The capture member also includes a bent portion located between the fixed end and the free end, and the bent portion is used to provide elastic force for the free end to return to its original state after swinging and deflecting. The bent portion is also provided with a fifth wire threading hole, and the fifth wire threading hole is used to adjust the elastic properties of the adjustment bent portion and provide a channel for the unlocking wire that extends from the distal end of the base to the proximal end of the conveying device.

17. The leaflet clamping system according to claim 14, characterized in that: The fixed end is fixedly connected to the fixing portion of the elastic locking member so that the capture member is fixedly connected to the base.

18. The leaflet clamping system according to claim 14, characterized in that: There are two capturing members, which are symmetrically arranged along the axial direction of the base. The fixed ends of the two capturing members are fixedly connected to each other to form an Ω-shaped capturing member group, and are sleeved and fixed on the outer side of the fixed part. The fixed end is provided with a fourth wire threading hole. After the unlocking wire passes through the base, it passes through the fourth wire threading hole and then extends to the proximal end of the conveying device.

19. The leaflet clamping system according to claim 14, characterized in that: There are two coupling members, which are symmetrically arranged on opposite sides of the proximal end of the base with respect to the axis of the base; there are two elastic locking members, which are symmetrically arranged in the accommodating through hole with respect to the axis of the base; there are two capturing members, which are symmetrically arranged with respect to the axis of the base; The unlocking wire includes a first unlocking wire and a second unlocking wire. The first unlocking wire extends from the proximal end of one side of the conveying device to the distal end to the base, and after entering the accommodating through hole, at least partially is located on a side of one of the clamping parts close to one of the coupling parts. After leaving the accommodating through hole, it is movably connected to one of the capturing parts and then extends toward the proximal end of the conveying device. The second unlocking wire extends from the proximal end of the other symmetrical side of the conveying device to the distal end to the base, and after entering the accommodating through hole, at least partially is located on a side of another of the clamping parts close to another of the coupling parts. After leaving the accommodating through hole, it is movably connected to another of the capturing parts and then extends toward the proximal end of the conveying device.

20. The leaflet clamping system according to claim 1, characterized in that: The delivery device also includes a delivery handle, a sheath and a drive wire; the proximal end of the unlocking wire, the proximal end of the drive wire and the proximal end of the sheath are all connected to the delivery handle, the distal end of the drive wire passes through the sheath and is detachably connected to the proximal end of the base of the leaflet clamping device to drive the clamping arm to rotate, the unlocking wire extends from the proximal end to the distal end, passes through the elastic locking piece, and then extends toward the delivery handle, and the sheath is detachably connected to the base.

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