Adjustable valve clip and valve clip system

Abstract

The present invention provides an adjustable valve clamp and a valve clamp system, wherein the valve clamp system comprises an adjustable valve clamp and a pushing device. The adjustable valve clamp comprises a push rod, at least two clamp arms, and at least one extension arm, wherein the push rod axially moves to drive the clamp arm to open and close relative to the push rod, and drives the extension arm to extend or retract along the axial direction of the clamp arm. The present invention arranges a retractable extension arm on the surface of the clamp arm of the valve clamp, and when the clamp arm is opened relative to the push rod, the extension arm extends out of the clamp arm, which is equivalent to increasing the effective length of capturing the leaflet. The longer clamp arm can provide a better supporting effect on the leaflet when capturing the leaflet, and prevent the leaflet from slipping off the surface of the clamp arm; after clamping, the extension arm can be retracted again, and the excessively long clamp arm and the extension arm can prevent the leaflet from being excessively pulled by the leaflet, thereby quickly and safely capturing the active leaflet through the adjustable clamping effective length, reducing the difficulty of surgery and improving the efficiency of surgery.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to an adjustable valve clamp and a valve clamp system. Background Art

[0002] See also Figure 1 The mitral valve 1 is a one-way valve located between the left atrium 2 and the left ventricle 3 of the heart. A normal and healthy mitral valve 1 can control the blood flow from the left atrium 2 to the left ventricle 3, while preventing the blood from the left ventricle 3 to the left atrium 2. The mitral valve includes a pair of leaflets, called the anterior leaflet 1a and the posterior leaflet 1b. The anterior leaflet 1a and the posterior leaflet 1b are fixed to the inner wall of the left ventricle 3 by chordae tendineae 4. Under normal circumstances, when the left ventricle of the heart contracts, the edges of the anterior leaflet 1a and the posterior leaflet 1b are completely aligned to prevent blood from flowing from the left ventricle 3 to the left atrium 2. Please refer to Figure 2 When the mitral valve leaflets or their related structures undergo organic or functional changes (such as partial rupture of the chordae tendineae 4), the anterior leaflet 1a and posterior leaflet 1b of the mitral valve are not properly aligned. When the left ventricle of the heart contracts, the mitral valve 1 cannot be completely closed, causing blood to flow back from the left ventricle 3 to the left atrium 2, thereby causing a series of pathophysiological changes, known as "mitral regurgitation."

[0003] There is a minimally invasive treatment surgery that delivers the leaflet clamp to the mitral valve through a delivery device, and then clamps the anterior and posterior leaflets of the mitral valve at the same time through the relative opening of the clamp, so that the anterior and posterior leaflets of the mitral valve are fixed to achieve the purpose of reducing mitral valve regurgitation. However, since the two leaflets of the mitral valve are always in a state of large-scale and strong opening and closing activities, it is difficult for the clamp to quickly and successfully capture the active leaflet tissue, and the operation time is long; and if the capture difficulty is reduced by directly increasing the size of the clamp, it will increase the difficulty of clamp delivery, or the clamp arm will over-pull the leaflet, causing leaflet damage. Summary of the invention

[0004] The purpose of the present invention is to provide an adjustable valve clamp and a valve clamp system to address the defects of the above-mentioned prior art. The adjustable valve clamp can easily, quickly and safely capture active leaflet tissue, thereby reducing the difficulty of surgery and improving surgical efficiency.

[0005] The adjustable valve clamp comprises a push rod, a fixed base, at least two clamp arms and at least one extension arm. The push rod passes through the fixed base and moves axially relative to the fixed base; the clamp arm comprises a connected clamping section and a driving section, the position between the clamping section and the driving section is hinged on the fixed base, the driving section is connected to the push rod, the push rod moves axially to drive the clamp arm to open and close relative to the push rod with the position hinged on the fixed base as the rotation center; the extension arm extends or retracts along the axial direction of the clamp arm, and when the extension arm extends along the driving section of the clamp arm toward the clamping section, the end of the extension arm exceeds the end of the clamp arm away from the driving section.

[0006] The valve clamping system includes a pushing device and the above-mentioned adjustable valve clamp, the pushing device includes an operating handle and a pushing shaft with a certain axial length, the proximal end of the pushing shaft is connected to the operating handle, and the distal end of the pushing shaft is detachably connected to the adjustable valve clamp.

[0007] The adjustable valve clamp and valve clamp system provided by the present invention are provided with an extension arm that can be extended or retracted along the axial direction of the clamp arm, so that when the clamp arm is opened relative to the push rod, the end of the extension arm exceeds the end of the clamp arm that is away from the driving section, which is equivalent to increasing the effective length for capturing the valve leaflet. The longer clamp arm can provide better support for the valve leaflet when capturing the valve leaflet, preventing the valve leaflet from slipping off the surface of the clamp arm; after clamping, the extension arm can be retracted again, preventing the excessively long clamp arm and the extension arm from excessively pulling the valve leaflet, thereby quickly and safely capturing the active valve leaflet tissue through the adjustable clamping effective length, reducing the difficulty of surgery and improving surgical efficiency. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] In order to more clearly illustrate the structural features and effects of the present invention, it is described in detail below in conjunction with the accompanying drawings and specific embodiments.

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

[0010] Figure 2 This is a schematic diagram of a mitral valve disease.

[0011] Figure 3 is a schematic structural diagram of an adjustable valve clipper when it is opened according to an embodiment of the present invention;

[0012] Figure 4 yes Figure 3 A front view of the adjustable valve clip with the clamp arms opened;

[0013] Figure 5 yes Figure 3 A front view of the adjustable valve clip when the clamp arms are folded;

[0014] Figure 6 is a schematic diagram of the position of the adjustable valve clip of the present invention at the mitral valve;

[0015] Figure 7 It is a schematic diagram of the mitral valve during heart contraction after the adjustable valve clip of the present invention clamps the valve leaflet;

[0016] Figure 8 It is a schematic diagram of the mitral valve when the heart is in diastole after the adjustable valve clip of the present invention clamps the valve leaflet;

[0017] Fig. 9 yes Figure 3 A schematic structural diagram of the connection between the push rod and the base of the adjustable valve clamp shown;

[0018] Fig.10 yes Figure 3 A schematic diagram of the structure of the adjustable valve clamp having a base connecting tube connected to a fixed base;

[0019] Fig.11 yes Fig.10 A cross-sectional view of the structure in which the base connecting tube of the adjustable valve clip is connected to the fixed base;

[0020] Fig.12 yes Figure 3 A schematic structural diagram of the clamp arm of the adjustable valve clamp shown;

[0021] Fig.13 is a schematic structural diagram of a clamp arm of an adjustable valve clamp according to another embodiment of the present invention;

[0022] Fig.14 is a schematic structural diagram of an adjustable valve clipper according to another embodiment of the present invention;

[0023] Fig.15 yes Figure 3 A schematic diagram of the structure of the adjustable valve clamp when the clamping arms are folded;

[0024] Fig.16 yes Figure 3 A schematic diagram of the structure of the adjustable valve clamp when the clamping arm is opened;

[0025] Fig.17 is a schematic structural diagram of an adjustable valve clipper in another embodiment of the present invention when it is folded;

[0026] Fig.18 yes Figure 3 and Fig.17 A schematic structural diagram of an extended arm of an adjustable valve clip according to the illustrated embodiment;

[0027] Fig.19 is a cross-sectional schematic diagram of an adjustable valve clipper in another embodiment of the present invention when it is opened;

[0028] Figure 20 to Figure 24 1 is a schematic structural diagram of a bearing portion of an extension arm of an adjustable valve clip according to different embodiments of the present invention;

[0029] Fig.25 The bearing portion of the extension arm is Fig.24 A schematic diagram of the structure of the adjustable valve clip when the structure of the embodiment shown is opened;

[0030] Figure 26 to Figure 27 1 is a schematic structural diagram of the bearing portion of the extension arm of the adjustable valve clip according to two other different embodiments of the present invention;

[0031] Fig.28 It is a structural schematic diagram of the adjustable valve clamp when the clamp arm of the valve clamp of one embodiment of the present application is in an open state and the valve clamp is connected to the push shaft;

[0032] Fig.29 yes Fig.28 A cross-sectional schematic diagram of the adjustable valve clip when connected to the push shaft;

[0033] Fig.30 It is a structural schematic diagram of an adjustable valve clamper in an embodiment of the present application when the clamp arm is in a retracted state and the adjustable valve clamper is connected to the adjustable pushing shaft;

[0034] Fig.31 yes Fig.30 The schematic cross-sectional view of the adjustable valve clamp being connected to the push shaft is shown. DETAILED DESCRIPTION

[0035] The following will be combined with the accompanying drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. The accompanying drawings are only used for illustrative purposes and represent only schematic diagrams, and cannot be understood as limitations on this patent. It should be emphasized that the "proximal end" mentioned in this application refers to the direction close to the operator; the "distal end" refers to the direction away from the operator.

[0036] See also Figures 3 to 5 The present invention provides an adjustable valve clip 100. The adjustable valve clip 100 includes a push rod 40, a fixed base 50, at least two clamp arms 11, and at least one extension arm 20. In this embodiment, the number of clamp arms 11 is two, and the two clamp arms 11 are symmetrically arranged with the push rod 40 as an axis and can be opened and closed relative to the push rod 40. The valve clip 100 of the present invention can be used for edge-to-edge repair of mitral valve regurgitation. For details, please refer to Figure 6, place the valve clip 100 at the position where the anterior leaflet and the posterior leaflet of the mitral valve cannot be normally aligned, so that one clamp arm 11 supports the edge of the anterior leaflet 1a of the mitral valve, and the other clamp arm 11 supports the edge of the posterior leaflet 1b of the mitral valve, and then fix the anterior leaflet 1a and the posterior leaflet 1b respectively through the cooperation of the clamp arm 11 and the push rod 40, so as to fix the position where the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve cannot be normally aligned together. Figure 7 The figure shows the state of the mitral valve when the heart contracts, where the arrow indicates the direction of blood flow. When the heart contracts, the anterior leaflet 1a and the posterior leaflet 1b move closer, and the edge of the anterior leaflet 1a and the edge of the posterior leaflet 1b are clamped together by the valve clamp 100, so that the mitral valve can be completely closed or the opening area becomes smaller, thereby alleviating or treating "mitral valve regurgitation". Figure 8 , Figure 8 The figure shows a schematic diagram of the state of the mitral valve during diastole, wherein the arrow direction is the direction of blood flow. When the heart is in diastole, the anterior leaflet 1a and the posterior leaflet 1b are fixed together only at the position where the valve clamp 100 clamps, and the other positions of the anterior leaflet 1a and the posterior leaflet 1b are still normally diastolic, so that a large amount of blood can enter the left ventricle from the left atrium, thereby ensuring the normal flow of blood. The adjustable valve clamp 100 of other embodiments of the present invention can also be used to alleviate or treat "tricuspid regurgitation", that is, the adjustable valve clamp 100 has three clamp arms 11, and the three valve leaflets are fixed together by the three clamp arms 11, thereby alleviating or avoiding "tricuspid regurgitation". Its principle and structure are the same as those of the adjustable valve clamp 100 used to solve mitral regurgitation in the embodiment of the present invention, and will not be repeated here. It is understandable that the adjustable valve clamp 100 of other embodiments of the present invention can also be applied to other minimally invasive surgical operations that require clamping several sheets of tissue together, and the number of forceps arms 11 can be changed according to actual usage requirements.

[0037] Please also read Figure 3 and Fig. 9 The push rod 40 passes through the fixed base 50 and moves axially relative to the fixed base 50 to push the clamp arm 11 to open and close relative to the push rod 40, and drives the extension arm 20 to move, so that the distal end of the extension arm 20 exceeds or retracts one end of the clamp arm 11. The proximal ring of the push rod 40 is provided with an annular groove 411, and the end surface of the proximal end of the push rod 40 is provided with a threaded hole 412 in the inner direction of the push rod 40 for connecting the delivery system of the adjustable valve clip 100. The push rod 40 includes a push rod body 41 and a connecting seat 43 provided at the distal end of the push rod body 41. The push rod body 41 can be a rod-shaped structure with any cross-sectional shape. For example, it can be a round rod or a square rod. In this embodiment, the push rod body 41 is a round rod, so that the push rod 40 is smoother during the movement.

[0038] In some embodiments of the present application, the connection seat 43 includes two opposite fixing plates 431 and a fixing block 432 fixed on the two fixing plates 431. The fixing block 432 is partially located between the two fixing plates 431 to connect the two fixing plates 431, and is partially located on the end surfaces of the two fixing plates 431 facing the push rod 40. Pin holes 433 are provided at opposite ends of each fixing plate 431, and the pin holes 433 on the two fixing plates 431 are arranged oppositely. Pin holes 434 are also provided on the fixing blocks 432 arranged on the end surfaces of the two fixing plates 431 facing the push rod 40. The axial directions of the pin holes 433 and the pin holes 434 are the same. The outer surface of the connection seat 43 is smooth, so as to facilitate its smooth advancement and prevent the connection seat 43 from damaging human tissue or hooking tendon chordae. The connection seat 43 can be a structure of any shape, such as a rectangular parallelepiped, a hemispherical body, a spherical cap, a bullet-shaped structure, etc. Preferably, the cross-sectional dimension of the connecting seat 43 perpendicular to the axial direction of the push rod 40 gradually decreases from the proximal end to the distal end, so that the adjustable valve clip 100 is easier to be pushed in the body.

[0039] The push rod 40 and the connecting seat 43 are made of biocompatible metal materials, specifically at least one selected from stainless steel, cobalt-chromium alloy, cobalt alloy or titanium alloy, preferably titanium alloy.

[0040] See also Figure 3 and Figure 10-11 In some embodiments of the present application, the adjustable valve clip 100 further includes a base connecting tube 60, which is sleeved on the outside of the push rod 40 and fixed to the fixed base 50. The fixed base 50 is provided with a through hole 51, which is communicated with the lumen of the base connecting tube 60. The push rod 40 is movably provided in the base connecting tube 60 and passes through the through hole 51 of the fixed base 50, and the push rod 40 can move axially relative to the base connecting tube 60 and the fixed base 50. In some embodiments, grooves 52 are provided on opposite sides of the fixed base 50, and pin holes 521 are provided on opposite groove walls of each groove 52, and the axial direction of the pin hole 521 is perpendicular to the axial direction of the push rod 40.

[0041] An opening 61 is provided on the base connecting tube 60, and an elastic sheet 62 is provided in the opening 61. The elastic sheet 62 includes a connecting end and a free end opposite to the connecting end, and the connecting end is connected to the edge of the opening 61. In a natural state, the free end is inclined toward the inside of the base connecting tube 60 relative to the connecting section. When the clamp arm 11 is retracted on the push rod 40, the free end of the elastic sheet 62 is inserted into the annular groove 411 at the proximal end of the push rod 40, preventing the push rod 40 from moving in the axial direction, so as to prevent the clamp arm 11 from opening relative to the push rod 40.

[0042] Furthermore, a connecting portion 63 is provided at the proximal end of the base connecting tube 60, which is used to connect with a pushing device that pushes the adjustable valve clip 100 to the heart valve. In some embodiments of the present application, the connecting portion 63 is a T-slot, and the T-slot includes a first slot section 631 and a second slot section 632 that intersects the first slot section 631. The extending direction of the first slot section 631 is the same as the axial direction of the base connecting tube 60, and is extended from the end surface of the proximal end of the base connecting tube 60 to the distal end of the proximal end of the base connecting tube 60.

[0043] Please also read Figure 5 and Fig.12 , Fig.12 The structure diagram of the clamp arm 11 in some embodiments of the present application is shown. Each clamp arm 11 includes a connected clamping section 111 and a driving section 112, and the position between the clamping section 111 and the driving section 112 is hinged on the fixed base 50. The clamping section 111 is a plate-like structure, and the driving section 112 includes two relatively parallel connecting strips 112a, and the two connecting strips 112a are connected to the proximal end of the clamping section 111. In some embodiments, the clamping section 111 and the driving section 112 are an integral structure obtained by integral molding. In this embodiment, the end surface of the clamping section 111 facing the driving section 112 is in contact with the end surface of the driving section 112 facing the clamping section 111, so as to realize the connection between the driving section 112 and the clamping section 111. A hinge hole 113 is provided at the position where the clamping section 111 and the driving section 112 are connected, and a pin 114 passes through the pin hole 521 on the fixed base 50 and the hinge hole 113, so that the clamp arm 11 is hinged to the fixed base 50, so that the push rod 40 moves axially to drive the clamp arm 11 to open and close relative to the push rod 40 with the position where it is hinged on the fixed base 50 (i.e., the hinge hole 113) as the rotation center.

[0044] The driving section 112 is provided with a slide groove 1121 extending along the length direction of the driving section 112. Specifically, the slide groove 1121 is provided on the connecting strip 112a of the driving section 112. The driving section 112 is connected to the push rod 40. A limiting column protruding from the surface of the push rod 40 and perpendicular to the axial direction of the push rod 40 is fixed on the distal end of the push rod 40. The limiting column passes through the slide groove 1121 of the driving section 112. The push rod 40 moves axially and drives the limiting column to slide in the slide groove 1121, so as to drive the clamp arm 11 to open and close relative to the push rod 40 with the position hinged on the fixed base 50 as the rotation center. In this embodiment, a pin 435 is inserted into the pin hole 434 of the fixed block 432 of the connecting seat 43, and the two ends of the pin 435 are exposed from the pin hole to protrude from the surface of the connecting seat 43. That is, the parts of the two ends of the pin 435 exposed from the pin hole are the limiting columns. The two connecting strips 112a of the driving section 112 are respectively located on both sides of the fixed block, and the portions (limiting columns) of the two ends of the pin 435 exposed from the pin hole 434 respectively pass through the slide grooves 1121 on the two connecting strips 112a and can move along the slide grooves 1121, so that when the push rod 40 drives the connecting seat 43 to move axially, the limiting column can slide in the slide groove 1121, thereby pushing the clamp arm 11 to open and close relative to the push rod 40 with the position (i.e., the hinge hole 113) hinged on the fixed base 50 as the rotation center. It can be understood that in some embodiments, the limiting column can also be a protruding structure fixed on two opposite surfaces of the connecting seat 43.

[0045] The clamping section 111 includes a first surface 11a facing the push rod 40, which is a concave surface that is concave away from the push rod 40, so that the clamp arm 11 can be more tightly closed to the push rod 40. In some embodiments, the concave surface is an arc surface, and the curvature radius of the arc surface is slightly larger than the curvature radius of the push rod 40.

[0046] Furthermore, in some embodiments, active drugs may be applied to the clamping section 111 of the clamp arm 11 , or one or more through holes 122 may be provided at intervals, which not only facilitates the crawling and growth of endothelial cells but also reduces the weight of the clamp arm 11 .

[0047] See also Fig.13 , Fig.13 This is another embodiment of the clamp arm 11 of the present application. Fig.12 The difference of the clamp arm 11 shown is that the clamping section 111 and the driving section 112 are partially overlapped together, and the hinge hole 113 is provided at the overlapping position of the clamping section 111 and the driving section 112 .

[0048] See also Fig.14In some other embodiments of the present application, a friction enhancing structure 115 is provided on the forceps arm 11 to enhance the friction between the forceps arm 11 and the valve leaflet, thereby providing a stable clamping force. The friction enhancing structure 115 can be a protrusion or a groove provided on the first surface 11a of the forceps arm 11 facing the push rod 40, or a gasket made of a biocompatible material with a high friction coefficient attached to the first surface 11a. In this embodiment, the friction enhancing structure 115 is a serrated structure provided on the edge of the forceps arm 11. In order to ensure a stable clamping force and adapt to the size of the valve leaflet, the clamping section 111 of the forceps arm 11 has certain size requirements. Specifically, when the clamping section 111 of the clamp arm 11 is too long, the clamping section 111 of the clamp arm 11 is easy to clamp too much of the anterior leaflet 1a and the posterior leaflet 1b together, and the two leaflets are forcibly pulled toward each other and fixed together, which is not only easy to cause mitral valve dysfunction, but also when the heart beats and the leaflets move, too many leaflets are restricted from moving, which may also cause leaflet tearing and other serious consequences; when the clamping section 111 of the clamp arm 11 is too short, only a small part of the leaflets can be clamped, making the leaflets easy to slip out, and the clamping and fixing effect is poor. In some embodiments of the present application, the axial length of the clamping section 111 of the clamp arm 11 (i.e., the length from the drive section 112 to the clamping section 111) should be greater than or equal to 4mm, preferably 6-10mm. In addition, the width of the clamping section 111 of the clamp arm 11 is also subject to certain restrictions, so as to avoid the clamping effect being affected by the width of the clamping section 111 of the clamp arm 11 being too narrow, and also to avoid the influence on the movement of the valve leaflets when the width of the clamping section 111 of the clamp arm 11 is too wide. The width of the clamping section 111 of the clamp arm 11 (i.e., the length in the direction perpendicular to the axial direction of the clamping section 111 of the clamp arm 11) should be greater than or equal to 2 mm, preferably 4-6 mm. In order to ensure safety after implantation, the clamp arm 11 should be made of a biocompatible material and have a certain degree of flexibility and rigidity, so as to avoid the clamp arm 11 from causing damage to the valve leaflets, while being able to clamp and fix the valve leaflets. Specifically, the biocompatible material is selected from stainless steel, cobalt alloy, cobalt-chromium alloy or titanium alloy.

[0049] Please review Figures 3 to 5 In one embodiment of the present application, the adjustable valve clamp 100 includes an elastic clamping member, which includes two clamping arms 12 arranged at an angle. Each clamping arm 12 corresponds to a clamp arm 11, and each clamping arm 12 is located between a corresponding clamp arm 11 and the push rod 40, and each clamp arm 11 is engaged with a clamp arm 12 to clamp the valve leaflet.

[0050] Please also read Figure 3 , Fig.15 and Fig.16 , Fig.15 Shown is a schematic structural diagram of a clamping member in some embodiments of the present application in a tightened (conveying) state; Fig.16The schematic diagram of the structure of the clamping member in some embodiments of the present application in the natural (released) state is shown. The clamping member is U-shaped and is cut from elastic materials with shape memory function such as nickel-titanium alloy and obtained by heat setting treatment. Fig.16 In this application, shape memory function means that the shape memory function will be deformed when subjected to external force and can return to its original shape after the external force disappears. Fig.15 The state shown is delivered in the catheter and returns to Fig.16 The state shown in the figure, thereby cooperating with the clamp arm 11 to clamp the leaflet. Each clamp arm 12 of the clamping member includes a free end 12a and a fixed end 12b arranged opposite to each other. The fixed end 12b is fixed to the fixed base 50. In some embodiments, the fixed end 12b is fixed between the fixed base 50 and the base connecting tube 60. In some embodiments, the fixed ends 12b of the two clamp arms 12 are connected to form an integral structure through a connecting piece 12c, and the connecting piece 12c is detachably or non-detachably fixedly connected to the fixed base 50 to achieve the fixation of the fixed ends 12b of the two clamp arms 12 to the fixed base 50. In some embodiments of the present application, the clamp arm 12 is at least partially made of an elastic material such as nickel-titanium alloy. In one embodiment of the present application, the fixed end 12b of the clamp arm 12 is made of an elastic material, and the free end 12a of the clamp arm 12 can be made of a non-elastic material such as an aluminum alloy, so that the movement of the free end 12a is driven by the rebound of the fixed end 12b. In the natural state, the clamping arm 12 is set at an angle to the push rod 40. The angle between the axes of the two clamping arms 12 ranges from 0° to 160°. In some embodiments, the angle between the two clamping arms 12 should be slightly larger than the angle between the two clamp arms 11 to provide a more stable clamping force, that is, the angle between each clamping arm 12 and the push rod 40 is larger than or equal to the angle between the clamp arm 11 and the push rod 40 when the clamp arm 11 corresponding to the clamp arm 12 is opened to the maximum state, thereby ensuring that there is a certain clamping force between the clamp arm 11 and the clamp arm 12 to clamp the leaflet between the clamp arm 11 and the clamp arm 12.

[0051] The free end 12a of the clamp arm 12 is connected to the control member 13 in the pushing device, and the free end 12a of the clamp arm 12 is controlled by the control member 13 to adjust the opening and closing between the clamp arm 12, the push rod 40 and the clamp arm 11. In this embodiment, the control member 13 is an adjustment wire made of metal or PTFE or other polymer materials, and the adjustment wire passes through the free end 12a of the clamp arm 12 to bind the clamp arm 12 to the surface of the push rod 40, so that the two clamp arms 12 are in a tightened state, which is conducive to the delivery through the sheath tube through the curved blood vessel; when the position of the clamp arm 11 and the valve leaflet is adjusted, the control of the free end 12a of the clamp arm 12 by the adjustment wire is released, and the clamp arm 12 rebounds to both sides and moves away from the push rod 40 and close to the clamp arm 11 due to its own elastic memory performance. At this time, the clamp arm 12 is in a natural state, and cooperates with the clamp arm 11 to clamp the valve leaflet located between them.

[0052] Further, the clamping arm 12 includes a third surface 12d opposite to the clamp arm 11. A clamping reinforcement 121 is provided on the third surface 12d to increase the friction between the clamping arm 12 and the leaflet, and improve the clamping force of the clamp arm 11 and the clamp arm 12 on the leaflet. The clamping reinforcement 121 can be a convex ridge, a barb, a boss or other irregularly distributed protrusions convexly arranged on the third surface 12d, or a rough surface at least partially covering the third surface 12d. For example, the third surface 12d of the clamping arm 12 is covered with a gasket made of a biocompatible material with a high friction coefficient to increase the surface roughness coefficient of the third surface 12d, thereby improving the clamping force of the adjustable valve clip 100 on the leaflet. The clamping reinforcement 121 can also be a magnetic body arranged on the clamping arm 12. In this case, a corresponding magnetic body is also arranged on the clamp arm 11, and the purpose of enhancing the clamping force is achieved through the mutual magnetic attraction between the clamp arm 11 and the clamp arm 12.

[0053] In one embodiment of the present application, the clamping reinforcement member 121 is two rows of convex teeth arranged at intervals. The two rows of convex teeth are arranged on the two side edges of the clamping arm 12. In addition, the angle between the axial direction of each convex tooth and the third surface 12d is less than or equal to 90° to further enhance the clamping force. Furthermore, the end of the convex tooth away from the third surface 12d is a smooth arc surface, thereby avoiding damage to the valve leaflet. In this embodiment, a through hole 122 is provided on the clamping arm 12 to reduce the weight of the clamping arm 12, enhance the elasticity of the clamping arm 12, and facilitate the climbing and growth of endothelial cells. Further, in some embodiments, the width of the clamp arm 11 is less than the width of the clamp arm 12, so that when the clamp arm 11 and the clamp arm 12 are matched, the convex teeth on the clamp arm 12 are located on both sides of the clamp arm 11, and the first surface of the clamp arm 11 is in contact with the third surface 12d of the clamp arm 12, thereby avoiding the convex teeth from affecting the matching of the clamp arm 11 and the clamp arm 12.

[0054] Please review Figure 3 , Figure 17-Figure 19 , there is at least one extension arm 20. The extension arm 20 is disposed on the surface or inside of the forceps arm 11. Preferably, at least one extension arm 20 is disposed on the inner surface and / or outer surface of each forceps arm 11, so that the length of each forceps arm 11 can be lengthened, so that each forceps arm 11 can easily capture the valve leaflet. In one embodiment of the present application, there are two extension arms 20, which are respectively disposed on the surfaces of two forceps arms 11. Specifically, the extension arm 20 can be disposed on the first surface 11a of the forceps arm 11 (i.e., the inner surface of the forceps arm 11) or on the second surface 11b opposite to the first surface 11a (i.e., the outer surface of the forceps arm 11). Figure 3 In the illustrated embodiment, the extension arm 20 is disposed on the first surface 11a of the clamp arm 11. Specifically, a limiter 14 is disposed on the first surface 11a of the clamp arm 11, and the limiter 14 is used to limit the extension direction of the extension arm 20 to the direction from the driving section 112 of the clamp arm 11 to the clamp section 111, thereby limiting the radial deviation of the extension arm 20. The limiter 14 can be a limiter ring, a limiter groove, a limiter tube, or other limiter structures. Specifically, in the present embodiment, the limiter 14 is a pipe having a certain length, and the extension arm 20 can be movably inserted into the pipe. Fig.17 In the illustrated embodiment, the extension arm 20 is disposed on the second surface 11b of the clamp arm 11. Specifically, a stopper 14 is disposed on the second surface 11b of the clamp arm 11, and the extension arm 20 passes through the stopper 14 to extend and retract along the driving section 112 of the clamp arm 11 toward the clamp section 111. In some embodiments, the extension arm 20 is disposed inside the clamp arm 11. Fig.16 In the illustrated embodiment, a through hole extending from the driving section 112 toward the clamping section 111 is provided in the clamp arm 11 , and the extension arm 20 is passed through the through hole so that the extension arm 20 is disposed inside the clamp arm 11 .

[0055] See also Fig.18In some embodiments of the present application, the extension arm 20 includes a fixed end 20a and a free end 20b opposite to each other, and the fixed end 20a is rotatably fixed to the distal end of the push rod 40. In one embodiment of the present application, the fixed end 20a is hinged to the connecting seat 43 at the distal end of the push rod 40, specifically located between two fixing plates 431 on the connecting seat 43. The fixed end 20a has a pin hole, and the pin 436 passes through the pin hole and two opposite pin holes 433 of the two fixing plates 431, thereby realizing the hinge connection between the fixed end 20a and the connecting seat 43, so that the extension arm 20 can be rotatably fixed relative to the connecting seat 43. When the push rod 40 is pushed axially, the push rod 40 drives the end of the extension arm 20 to exceed or retract the end of the clamp arm 11 away from the driving section 112. Specifically, when the push rod 40 moves axially toward the distal end, it can drive the end of the extension arm 20 to retract along the axial direction of the clamp arm 11; when the push rod 40 moves axially toward the proximal end, it can drive the end of the extension arm 20 to extend along the axial direction of the clamp arm 11. At the same time, in some embodiments of the present application, since the axial movement of the push rod 40 can drive the clamp arm 11 to open and close relative to the push rod 40 and the extension arm 20 to extend and retract along the axial direction of the clamp arm 11, the extension or retraction of the extension arm 20 is synchronized with the opening or closing of the clamp arm 11 relative to the push rod 40, so that the effective length of the clamp arm 11 is extended by controlling the axial extension and contraction of the extension arm 20 relative to the clamp arm 11 without adding additional surgical operation steps, thereby reducing the difficulty of the operation.

[0056] In some embodiments, the adjustable valve clip 100 further includes an extension arm steel sleeve 21, and the fixed end 20a of the extension arm 20 is fixed to the extension arm steel sleeve 21 by welding or crimping. The end of the extension arm steel sleeve 21 away from the extension arm 20 is located between the two fixing plates 431 on the connecting seat 43. In addition, a pin hole is provided on the end of the extension arm steel sleeve 21 away from the extension arm 20, and the pin passes through the pin hole on the extension arm steel sleeve 21 and the two ends of the pin are fixed in the two opposite pin holes 433 of the two fixing plates 431, thereby realizing the rotational fixation of the extension arm steel sleeve 21 and the connecting seat 43, and further realizing the rotational fixation of the fixed end 20a of the extension arm 20 and the connecting seat 43.

[0057] In this embodiment, by pushing the push rod 40 toward the distal end, the limiting column moves in the slide groove 1121 toward the clamping section 111. At this time, since the distance from the limiting column to the end direction of the clamping section 111 (i.e., the direction in which the clamping section 111 is away from the driving section 112) is shortened, the end of the extension arm 20 can partially exceed the end of the clamp arm 11 that is away from the driving section 112; when the push rod 40 is pulled toward the proximal direction, the limiting column moves in the slide groove 1121 toward the direction away from the clamping section 111. At this time, since the distance from the limiting column to the end direction of the clamping section 111 (i.e., the direction in which the clamping section 111 is away from the driving section 112) is increased, the end of the extension arm 20 can be retracted to the end of the clamp arm 11 that is away from the driving section 112. In some embodiments, the length of the extension arm 20 is the same as the length of the clamp arm 11. When the clamp arm 11 is opened relative to the push rod 40, the distance from the limit column to the end direction of the clamp section 111 (i.e., the direction in which the clamp section 111 is away from the driving section 112) is shortened, so that the length of the portion of the clamp arm 11 that clamps the valve leaflet is shortened. However, after adding the length of the extension arm 20 extending out of the end of the clamp arm 11, the actual length of the clamp arm 11 that captures the valve leaflet does not change, so that the valve leaflet can still be captured relatively easily. However, since the distance from the limit column to the end direction of the clamp section 111 is shortened, the length of the clamp arm 11 that clamps the valve leaflet is shortened, thereby avoiding the problem that the adjustable valve clip 100 is too long and the valve leaflet is over-pulled.

[0058] See also Fig.19 In other embodiments of the present application, the extension or retraction of the extension arm 20 and the opening or closing of the clamp arm 11 relative to the push rod 40 may also be asynchronous. Fig.19 In the illustrated embodiment, the push rod 40 includes a hollow cavity 44, and the extension direction of the hollow cavity 44 is the same as the axial direction of the push rod 40. The extension arm 20 is made of elastic material, and includes a first section 20c, a second section 20d, and a third section 20e connecting the first section 20c and the second section 20d. The third section 20e is a curved section, the first section 20c extends or retracts along the axial direction of the clamp arm 11, and the second section 20d is movably arranged in the hollow cavity 44 and can be further extended outside the patient's body or connected to other control rods extending outside the patient's body. When the second section 20d moves along the hollow cavity 44, it can drive the first section 20c to extend or retract along the axial direction of the clamp arm 11. In this embodiment, after the forceps arm 11 is fully opened by the axial movement of the push rod 40, the second section 20d of the extension arm 20 is driven to move along the hollow cavity 44, so that the end of the first section 20c of the extension arm 20 extends out of the end of the forceps arm 11 away from the driving section 112, and the end of the first section 20c of the extension arm 20 can be adjusted in real time to extend to a suitable position. Furthermore, after the forceps arm 11 is retracted relative to the push rod 40, the extension arm 20 can be withdrawn from the body, thereby reducing implanted components.

[0059] Preferably, the extension arm 20 is smooth as a whole, and one end of the extending clamp arm 11 is formed into a smooth round head by laser spot welding without defects such as burrs, edges, and corners, thereby avoiding damage to the valve leaflet.

[0060] In some embodiments of the present invention, the extension arm 20 includes an extension arm body. The extension arm body includes one or more support rods arranged side by side to directly support the leaflets through the support rods. The support rods can be solid or hollow structures, or single-layer or multi-layer composite structures. Furthermore, in this embodiment, the support rods are made of flexible and / or elastic biocompatible materials to adapt to the anatomical structure of the leaflets and the range of motion of the leaflets, and to avoid damaging the leaflets. For example, metal materials, polymer materials or metal-polymer composite materials can be selected. Specifically, the support rods are made of metal-polymer composite materials, and in this embodiment, nickel-titanium alloy and PTFE are used.

[0061] Further, in other embodiments of the present invention, the extension arm 20 includes an extension arm body made of a flexible material, and also includes a support body, which is made of a rigid material, such as stainless steel or titanium alloy. The support body is arranged inside and / or outside the extension arm body to enhance the strength of the extension arm 20, so that the extension arm 20 has a certain flexibility to adapt to the anatomical structure of the valve leaflet and the range of motion of the valve leaflet, and has a certain rigidity to effectively support the valve leaflet. For example, in another embodiment of the present invention, the extension arm body is wound by at least one flexible wire (such as a stainless steel wire), and then a thermoplastic elastomer (such as Pebax) is wrapped around the outside of the extension arm body, and then heated to melt the Pebax and cover the outside of the extension arm body. At the same time, part of the Pebax will penetrate into the extension arm body through the gaps between the flexible wires. Therefore, the support body at this time is arranged inside and outside the extension arm body. Further, the extension arm 20 is at least partially made of a non-transmissive X-ray material. For example, the extension arm body and / or the support body are made of non-transmissive X-ray materials, so that after the extension arm 20 extends from the adjustable valve clip 100 and contacts the valve leaflet, the extension arm 20 can swing accordingly with the movement amplitude of the valve leaflet. At this time, the operator can quickly and accurately determine the position of the valve leaflet through X-rays. If the position is reasonable, the operator can drive the adjustable valve clip 100 to clamp the valve leaflet, thereby shortening the operation time and improving the success rate of the operation. The non-transmissive X-ray material is selected from stainless steel or nickel-titanium alloy.

[0062] See also Figure 20 to Figure 24 , Figure 20 to Figure 24Schematic diagram of the structure of the extension arm of other embodiments of the present application. In these embodiments, the free end 20b of the extension arm 20 is further provided with a bearing portion 22. When the end of the extension arm 20 exceeds the end of the clamp arm 11 away from the drive section 112, the width of the bearing portion 22 is greater than the diameter of the extension arm 20, so that the bearing portion 22 has a larger supporting area, thereby better supporting the leaflet. Among them, the width direction of the bearing portion 22 is the same as the width direction of the clamp arm 11. The bearing portion 22 can be a plate-like structure with or without elasticity, or it can be other elastic parts. Fig. 20 As shown, the bearing portion 22 is a plate-like structure, specifically a flat plate without elasticity. Figure 21 to Figure 24 As shown, the bearing portion 22 is an elastic member. When the extension arm 20 is retracted into the clamp arm 11, the elastic member is compressed and in a compressed state. When the extension arm 20 extends out of the clamp arm 11, that is, when the end of the extension arm 20 exceeds the end of the clamp arm 11 away from the driving section 112, the elastic member is no longer compressed by the outside and is stretched and in a stretched state. The area of ​​the elastic member in the stretched state is greater than the area of ​​the elastic member in the compressed state, so that the elastic member has a larger contact area with the leaflets, so as to better fit the leaflets and improve the support of the extension arm 20 to the leaflets. Preferably, in the present invention, the surface where the elastic member is stretched is parallel to the first surface 11a of the clamp arm 11, so that the elastic member has a larger contact area with the leaflets after stretching, thereby achieving a better support effect on the leaflets. Specifically, the first surface 11a and the surface where the elastic member is stretched can be both planes or curved surfaces.

[0063] Fig.21 In the illustrated embodiment, the bearing portion 22 includes a plurality of branches. When the bearing portion 22 is retracted into the clamp arm 11, the plurality of branches are bundled together; when the bearing portion 22 is extended out of the clamp arm 11, the plurality of branches are stretched out, so that the area of ​​the bearing portion 22 is increased relative to when the bearing portion 22 is retracted into the clamp arm 11. Fig. 22 In the illustrated embodiment, the bearing portion 22 is a closed elastic ring. The elastic ring may be a closed structure of a circle, a rhombus, an ellipse, a pear, a polygon or other irregular shapes. When the elastic ring is retracted into the clamp arm 11, the elastic ring is squeezed and deformed; when the elastic ring is extended out of the clamp arm 11, the elastic ring stretches, and the area of ​​the elastic ring after stretching is larger than the area of ​​the elastic ring when squeezed, thereby enhancing the support of the extension arm 20 to the leaflet. For further information, please refer to Fig.23 At least one support strip 23 is provided in the elastic ring to improve the stability of the elastic ring. Furthermore, the extension direction of the support strip 23 is the same as the direction from the driving section 112 to the clamping section 111 of the clamp arm 11, so that the elastic ring can still be easily retracted in the clamp arm 11 after adding the support strip 23. Fig.24In another embodiment of the present invention, the bearing portion 22 is a deformable mesh cage. Specifically, the bearing portion 22 is a cage-like structure woven from silk threads having a certain elasticity and tension. When the mesh cage is received in the forceps arm 11, it is squeezed and deformed and is in a compressed state. When the mesh cage extends out of the forceps arm 11, the mesh cage stretches, and the volume of the stretched mesh cage is larger than the volume of the mesh cage when squeezed, thereby providing more stable support for the leaflets supported by the extension arm 20. In the present application, the silk thread forming the mesh cage can be an elastic metal wire or a polymer wire with a shape memory function. In this embodiment, a superelastic nickel-titanium wire is used, which has good biocompatibility and can be developed under X-rays. Furthermore, compared to the Figure 20-23 For the supporting portion 22 in the embodiment shown, the supporting portion 22 of this embodiment is a three-dimensional structure, which can have a more three-dimensional imaging effect and can provide a more stable support for the leaflets supported by the extension arm 20 (such as Fig.25 as shown).

[0064] Please also read Fig.24 and Fig.25 In this embodiment, the mesh cage includes a woven mesh 221 and a head 222 and a fixed tube 223 respectively fixed at both ends of the woven mesh 221. Specifically, the nickel-titanium wire forms a cylindrical woven mesh 221, and one end of the woven mesh 221 is fixed in the head 222. That is, the head 222 gathers and fixes an open end of the woven mesh 221. The other end of the woven mesh 221 is gathered and fixed in the fixed tube 223. The end of the fixed tube 223 facing away from the woven mesh 221 is connected to the extension arm 20. The head 222 and the fixed tube 223 can be made of metal or polymer material. In this embodiment, the head 222 and the fixed tube 223 are both made of stainless steel.

[0065] In this embodiment, the middle part of the mesh cage is columnar, and the two ends are cones, and the cone angles of the cones at the two ends are the same. It can be understood that in this application, the mesh cage can also be any other shape. For example, refer to Fig.26 and Fig. 27 , the cage can be Fig.26 The spindle-shaped structure with the same cone angle at both ends can also be Fig. 27 The structure shown has different cone angles at both ends.

[0066] See also Figure 28-Figure 31The present invention also provides a valve clamping system, which includes a pushing device and the aforementioned adjustable valve clamp 100. The adjustable valve clamp 100 can be delivered to the mitral valve by the pushing device, and the adjustable valve clamp 100 can be adjusted to a suitable position of the mitral valve. The pushing device includes an operating handle for the operator to hold and a pushing shaft connected to the distal end of the operating handle and having a certain axial length. The proximal end of the pushing shaft is connected to the operating handle, and the distal end of the pushing shaft is detachably connected to the adjustable valve clamp 100. Specifically, the pushing shaft includes a core shaft 210, a liner 220 sleeved outside the core shaft 210, and an outer tube 230 sleeved outside the liner 220. The operating handle can drive the core shaft 210, the liner 220, and the outer tube 230 to move relative to each other.

[0067] The distal end of the mandrel 210 has an external thread 211 corresponding to the internal thread in the threaded hole 412 at the proximal end of the push rod 40. When the push shaft is connected to the valve clipper 100, the distal end of the mandrel 210 is threadedly connected to the proximal end of the push rod 40, and the mandrel 210 is driven to move by the operating handle, thereby realizing the axial movement of the push rod 40. In some embodiments, the mandrel 210 is a hollow tube, and the second section 20d of the extension arm 20 passes through the mandrel 210 and is connected to the operating handle, so that the length of the end of the extension arm 20 extending out of the clamp arm 11 away from the driving section 112 can be adjusted in vitro by the operating handle.

[0068] A T-shaped spring piece 231 is provided on the distal end of the outer tube 230, which is used to cooperate with the T-shaped slot 63 on the base connecting tube 60 to achieve the connection and unlocking of the outer tube 230 and the base connecting tube 60. In the natural state, one end of the T-shaped spring piece is connected to the distal end of the outer tube 230, and the other end is inclined toward the position where the axis of the outer tube 230 is located. Specifically, when the push shaft is connected to the valve clamp 100, the core shaft 210 is threadedly connected to the push rod 40, and the operating handle drives the liner 220 to move, so that when the liner 220 extends into the base connecting tube 60, the liner 220 lifts the T-shaped spring piece 231 of the outer tube 230, so that the T-shaped spring piece 231 is embedded in the T-shaped slot 63 of the base connecting tube 60, and the base connecting tube 60 and the outer tube 230 are in a connected state; when the operating handle is operated to make the liner 220 leave the base connecting tube 60, the T-shaped spring piece 231 of the outer tube 230 is in a natural state, that is, it is deformed inward and disengaged from the T-shaped slot 63, so that the base connecting tube 60 and the outer tube 230 are unlocked.

[0069] The following takes the mitral valve repair process as an example to illustrate the operation method of the valve clipping system of the present invention, which mainly includes the following steps:

[0070] Step 1: Connect the push shaft to the adjustable valve clamp 100. Rotate the core shaft 210 of the push shaft so that the core shaft 210 is fixed to the push rod 40. Move the liner 220 axially toward the distal end to lift the T-shaped spring piece 231 of the outer tube 230 so that the T-shaped spring piece 231 is embedded in the T-shaped groove 63 of the base connecting tube 60, so that the base connecting tube 60 and the outer tube 230 are in a connected state. At this time, the free end of the spring piece 62 on the base connecting tube 60 is located in the annular groove 411 of the push rod 40, so that the clamp arm 11 and the clamping arm 12 are both retracted on the surface of the push rod 40. At this time, the connection state of the push shaft and the adjustable valve clamp 100 is as shown in FIG. Fig.21 and Fig. 22 shown.

[0071] Step 2: Push the adjustable valve clip 100 connected to the valve clip 100 from the left atrium through the mitral valve to the left ventricle via the pushing shaft.

[0072] Step 3: Move the liner 220 axially to the distal end so that the liner 220 lifts the free end of the spring sheet 62 on the base connecting tube 60 so that the free end of the spring sheet 62 is separated from the annular groove 411. At this time, the push rod 40 can move axially in the base connecting tube 60.

[0073] Step 4: Move the core shaft 210 proximally by operating the handle, thereby driving the push rod 40 connected to the core shaft 210 to move proximally to drive the clamp arm 11 to open relative to the push rod 40 and at the same time make the extension arm 20 extend from the clamp arm 11.

[0074] It is understandable that when the adjustable valve clip 100 is Fig.19 When using the valve clamp as shown, the second section 20d of the extension arm 20 can also be pushed in the distal direction by operating the handle so that the second section 20d pushes the distal end of the first section 20c further away from the end of the clamp arm 11 that is away from the drive section 112, thereby further extending the actual length of the clamp arm 11 to capture the leaflet.

[0075] Step 5: Adjust the direction of the adjustable valve clamp 100, and observe the relative position of each clamp arm 11 and the anterior leaflet 1a and the posterior leaflet 1b through X-ray equipment, so that the clamp arm 11 is perpendicular to the mitral valve coaptation line.

[0076] Step 6: withdraw the entire adjustable valve clip 100 toward the proximal end, so that the clamp arm 11 and the extension arm 20 hold the valve leaflet on the ventricle side.

[0077] Step 7: Release the clamping arm 12 through the control member, so that the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve are clamped between a pair of forceps arms 11 and the clamping arm 12 respectively, thereby grasping the valve leaflets.

[0078] Step 8: Move the mandrel 210 to the distal end, and the mandrel 210 drives the push rod 40 to move to the distal end, thereby driving the clamp arm 11 to retract and causing the extension arm 20 to be retracted into the limiter 14, that is, the end of the extension arm 20 retracts.

[0079] Step 9: The outer tube 230 is fixed, and the liner 220 is withdrawn to the proximal end for a certain stroke. At this time, the free end of the spring piece 62 of the base connecting tube 60 is inserted into the annular groove 411 of the push rod 40 to ensure that the clamp arm 11 is always closed. The core shaft 210 is controlled to rotate by the operating handle so that the threads between the core shaft 210 and the push rod 40 are unlocked. The liner 220 and the core shaft 210 are withdrawn to the proximal end until the T-shaped spring piece 231 of the outer tube 230 is unlocked and separated from the T-shaped groove 63 of the base connecting tube 60. At this time, the adjustable valve clip 100 is completely separated from the push shaft. The push shaft is withdrawn from the patient's body, and the valve clip 100 is left in the patient's body to complete the edge-to-edge repair of the mitral valve leaflet.

[0080] The valve clipping system of the present invention can be operated in vitro to clip the valve leaflets with the valve clipper, thereby alleviating or avoiding the problem of "mitral regurgitation". In addition, since the valve clipper can easily capture the valve leaflets, the difficulty of performing "mitral regurgitation" surgery with the valve clipping system is greatly reduced, and the operation time is reduced.

[0081] The above is only a specific embodiment of the present invention, but the protection scope of the present invention is not limited thereto. Any person skilled in the art can easily think of changes or substitutions within the technical scope disclosed by the present invention, which should be included in the protection scope of the present invention. Therefore, the protection scope of the present invention should be based on the protection scope of the claims.

Claims

1. An adjustable valve clip, characterized in that: include: Putting; A fixed base, wherein the push rod passes through the fixed base and moves axially relative to the fixed base; At least two clamp arms, the clamp arms include a connected clamping section and a driving section, the position between the clamping section and the driving section is hinged on the fixed base, the driving section is provided with a slide groove, the limit column of the push rod passes through the slide groove, the driving section is slidably connected with the push rod, and the push rod moves axially to drive the clamp arm to open and close relative to the push rod with the position hinged on the fixed base as the rotation center; At least one extension arm, the push rod moves axially to drive the extension arm to extend or retract along the axial direction of the clamp arm, and when the extension arm extends along the driving section of the clamp arm toward the clamping section, the end of the extension arm exceeds the end of the clamp arm away from the driving section.

2. The adjustable valve clip according to claim 1, characterized in that: The driving section is provided with a slide groove extending along the length direction of the driving section, and a limiting column protruding from the surface of the push rod and perpendicular to the axial direction of the push rod is fixed on the distal end of the push rod. The push rod moves axially and drives the limiting column to slide in the slide groove.

3. The adjustable valve clip according to claim 1, characterized in that: The forceps arm is provided with a friction enhancement structure, and the friction enhancement structure is used to enhance the friction between the forceps arm and the valve leaflet.

4. The adjustable valve clip according to claim 1, characterized in that: The extension arm is movably arranged on the surface of the clamp arm or penetrates inside the clamp arm.

5. The adjustable valve clip according to any one of claims 1, 3 or 4, characterized in that: The extension arm comprises a free end and a fixed end which are arranged opposite to each other, and the fixed end is hinged to the distal end of the push rod.

6. The adjustable valve clip according to claim 5, characterized in that: The extension or retraction of the extension arm is synchronized or asynchronous with the opening or closing of the clamp arm relative to the push rod.

7. The adjustable valve clip according to any one of claims 1 to 4, characterized in that: The push rod includes a hollow cavity, and the extension direction of the hollow cavity is the same as the axial direction of the push rod; the extension arm includes a first section, a second section and a third section connecting the first section and the second section, the third section is a curved section, the second section is movably arranged in the hollow cavity, and the second section moves along the hollow cavity to drive the first section to extend or retract along the axial direction of the clamp arm.

8. The adjustable valve clip according to claim 1, characterized in that: A bearing portion is provided at the end of the extension arm. When the end of the extension arm exceeds the end of the clamp arm away from the driving section, the width of the bearing portion is greater than the diameter of the extension arm, and the width direction of the bearing portion is the same as the width direction of the clamp arm.

9. The adjustable valve clip according to claim 8, characterized in that: The bearing part is a plate-shaped structure.

10. The adjustable valve clip according to claim 8, characterized in that: The bearing part is an elastic member, which has a compressed state and a stretched state. The area of ​​the elastic member in the stretched state is larger than the area of ​​the elastic member in the compressed state. When the end of the extension arm exceeds the end of the clamp arm away from the driving section, the elastic member is in the stretched state.

11. The adjustable valve clip according to claim 10, characterized in that: The elastic member is a deformable mesh cage.

12. The adjustable valve clip according to claim 11, characterized in that: The mesh cage comprises a cylindrical woven mesh and a sealing head and a fixing pipe respectively fixed at two ends of the woven mesh.

13. The adjustable valve clip according to claim 1, characterized in that: The valve clipper also includes a base connecting tube, which is sleeved outside the push rod and fixed to the fixed base.

14. The adjustable valve clip according to claim 13, characterized in that: The proximal ring of the push rod is provided with an annular groove, and the base connecting tube is provided with an elastic sheet. When the clamp arm is in a retracted state, one end of the elastic sheet is stuck in the annular groove.

15. The adjustable valve clip according to claim 1, characterized in that: The adjustable valve clipper further comprises a clamping member for cooperating with the clamp arm to clamp the valve leaflet, wherein the clamping member comprises at least two clamping arms, and each of the clamping arms is located between one of the clamp arms and the push rod.

16. The adjustable valve clip according to claim 15, characterized in that: Each of the clamping arms comprises a free end and a fixed end which are arranged opposite to each other, and the fixed end of the clamping arm is fixed on the fixed base.

17. The adjustable valve clip according to claim 15, characterized in that: Each of the clamping arms is at least partially made of an elastic material having shape memory function.

18. The adjustable valve clip according to claim 15, characterized in that: The clamping arm comprises a clamping surface opposite to the clamp arm, and a clamping reinforcement piece is disposed on the clamping surface.

19. A valve clamping system, characterized in that: It comprises a pushing device and the adjustable valve clamp according to any one of claims 1 to 18, wherein the pushing device comprises an operating handle and a pushing shaft, wherein the proximal end of the pushing shaft is connected to the operating handle, and the distal end of the pushing shaft is detachably connected to the adjustable valve clamp.

20. The valve clipping system according to claim 19, wherein: The push shaft includes a core shaft, a liner and an outer tube that are movably and coaxially sheathed together, wherein the liner is located between the core shaft and the outer tube; the core shaft is detachably connected to the push rod, and the core shaft is used to push the push rod to move axially.

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