Valve clip with membrane and valve clip system

Abstract

The present invention provides a valve clamping system, including a pushing device and a valve clamp with a coating. The valve clamp includes a push rod, a coating, and a proximal clip and a distal clip that are radially unfolded relative to the push rod. The distal clip is connected to the push rod, the proximal clip is arranged between the push rod and the distal clip, and a valve accommodating space is formed between the proximal clip and the distal clip. The push rod can drive the distal clip to radially unfold, and the proximal clip relies on its own elasticity to unfold and then move close to the distal clip to clamp the valve tissue located in the valve accommodating space. The coating includes a first coating covering at least one side of the proximal clip facing the valve accommodating space and / or a second coating covering at least one side of the distal clip facing the valve accommodating space. The present invention also provides a valve clamp with a coating. The present invention can reduce or avoid damage to the clamped valve tissue by covering at least part of the surface of the proximal clip and / or the distal clip with the coating.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to a valve clamp with a membrane 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 1 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 papillary muscle 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 organic or functional changes occur in the leaflets of the mitral valve or its related structures, such as partial rupture of the chordae tendineae 4, the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1 are not properly aligned. As a result, when the left ventricle 3 of the heart contracts, the mitral valve 1 cannot be completely closed, causing blood to reflux 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, in which a leaflet clamp is delivered to the mitral valve through a delivery device, and then the anterior leaflet and the posterior leaflet of the mitral valve are clamped at the same time by the relative opening of the clamp, so that the anterior leaflet and the posterior leaflet of the mitral valve are fixed, thereby achieving the purpose of narrowing the leaflet gap and reducing mitral regurgitation. However, in the prior art, the distal and proximal clips of the clamp are made of metal materials, which may cause tissue allergies or inflammatory reactions, and the sharp edges of the metal may also cause pinching or scratching of the leaflets, resulting in mitral valve diseases. Summary of the invention

[0004] In view of this, the present invention provides a valve clipper and a valve clipping system which can reduce or avoid damage to valve tissue.

[0005] In order to solve the above technical problems, the present invention provides a valve clamp with a coating, comprising a push rod, a coating, and a proximal clip and a distal clip that are radially expanded relative to the push rod; wherein the distal clip is connected to the push rod, the proximal clip is arranged between the push rod and the distal clip, and a valve accommodating space is formed between the proximal clip and the distal clip, the push rod can drive the distal clip to radially expand, and the proximal clip relies on its own elasticity to expand and then move close to the distal clip to clamp the valve tissue located in the valve accommodating space, and the coating comprises a first coating covering at least one side of the proximal clip facing the valve accommodating space and / or a second coating covering at least one side of the distal clip facing the valve accommodating space.

[0006] The present invention also provides a valve clamping system, including a pushing device and the above-mentioned valve clamper, wherein the pushing device includes an operating handle and a pushing assembly, the proximal end of the pushing assembly is connected to the operating handle, and the distal end of the pushing assembly is detachably connected to the valve clamper.

[0007] The valve clamp and valve clamp system provided by the present invention can wrap up at least a portion of the metal surface and / or the sharp metal edge of the proximal clip and / or the distal clip by providing a coating on at least a portion of the surface of the proximal clip and / or the distal clip of the valve clamp, thereby preventing at least a portion of the metal surface and / or the sharp metal edge of the valve clamp from directly contacting the valve tissue clamped in the valve accommodating space, thereby reducing or avoiding tissue allergies and inflammatory reactions, and avoiding damage to the clamped valve tissue. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] In order to more clearly illustrate the technical solution of the embodiment of the present invention, the drawings required for use in the implementation mode will be briefly introduced below. Obviously, the drawings described below are some implementation modes of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[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 It is a schematic diagram of a valve clipper in an open state provided by one embodiment of the present invention.

[0012] Figure 4 yes Figure 3 Schematic diagram of the valve clip in the closed state.

[0013] Figure 5 yes Figure 3 Schematic diagram of the structure of the valve clip when it is not covered.

[0014] Figure 6 yes Figure 5 A schematic diagram of the structure from another perspective.

[0015] Figure 7 yes Figure 4 Schematic diagram of the structure of the valve clip when it is not covered.

[0016] Figure 8 yes Figure 6 An enlarged schematic diagram of part VIII in FIG.

[0017] Fig. 9 yes Figure 6 Exploded view of the fixed base in FIG.

[0018] Fig.10 yes Figure 6 Schematic diagram of the structure of the proximal clip in .

[0019] Fig.11 yes Fig.10 Schematic diagram of the proximal clip covering the first coating.

[0020] Fig.12 yes Figure 3 Schematic diagram of the distal clip of the valve clip in FIG. 1 with the distal clip resting under the valve leaflet.

[0021] Fig.13 yes Figure 3 Schematic diagram of the proximal clip of the valve clip moving close to the distal clip to clamp the valve.

[0022] Fig.14 yes Figure 3 Schematic diagram of the position of the valve clip when in use.

[0023] Fig.15 yes Fig.14 Schematic diagram of the mitral valve during heart contraction after the valve leaflets are clamped by the valve clip in the figure.

[0024] Fig.16 yes Fig.14 Schematic diagram of the mitral valve during diastole after the valve leaflets are clamped by the valve clip in the figure.

[0025] Fig.17 It is a partial structural schematic diagram of a valve clamping system provided in one embodiment of the present invention.

[0026] Fig.18 yes Fig.17 Schematic cross-section of .

[0027] Fig.19 It is a schematic diagram of a valve clipper in an open state provided by another embodiment of the present invention.

[0028] Fig. 20 yes Fig.19 Schematic diagram of the valve clip in the uncovered state.

[0029] Fig.21 yes Fig.19 Schematic diagram of the distal clip of the valve clip being flipped.

[0030] Fig. 22 It is a schematic diagram of a valve clipper in an open state provided by another embodiment of the present invention. DETAILED DESCRIPTION

[0031] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0032] In the description of the present invention, it should be noted that the directions or positional relationships indicated by the terms "upper", "lower", "left", "right", "inner", "outer", etc. are based on the directions or positional relationships shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific direction, be constructed and operated in a specific direction, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", "third", etc. are only used for descriptive purposes and cannot be understood as indicating or implying relative importance.

[0033] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", "connected", etc. should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be directly connected or indirectly connected through an intermediate medium. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0034] In the description of the present invention, it should be noted that in the field of interventional medical devices, the proximal end refers to the end closer to the operator, while the distal end refers to the end farther from the operator, and the axial direction refers to the direction parallel to the line connecting the distal center and the proximal center of the medical device; the above definitions are only for convenience of expression and should not be understood as limitations on the present invention.

[0035] See also Figures 3 to 5 The present invention provides a valve clip 100, comprising a push rod 10 extending in the axial direction, a proximal clip 21, a distal clip 23 and a coating 30. The proximal clip 21 and the distal clip 23 are radially extended relative to the push rod 10, the distal end of the distal clip 23 is connected to the push rod 10, the proximal clip 21 is arranged between the push rod 10 and the distal clip 23, and a valve accommodating space 25 is formed between the proximal clip 21 and the distal clip 23. The push rod 10 can drive the distal clip 23 to radially expand, and the proximal clip 21 is close to the distal clip 23 due to its own elasticity to clamp the valve tissue located in the valve accommodating space 25. The coating 30 includes a first coating 31 covering at least one side of the proximal clip 21 facing the valve accommodating space 25 and / or a second coating 32 covering at least one side of the distal clip 23 facing the valve accommodating space 25.

[0036] A group of proximal clamps 21 and distal clamps 23 respectively constitute a clamp 20 .

[0037] To ensure safety after implantation, the proximal clip 21 and the distal clip 23 are both made of biocompatible metal materials, which are selected from commonly used implant metal materials such as stainless steel, cobalt alloy, cobalt-chromium alloy, titanium alloy or nickel-titanium alloy. Among them, the proximal clip 21 is made of an elastic material with shape memory function, and the distal clip 23 is made of a rigid material to ensure that the two can clamp and fix the valve tissue. In this embodiment, the proximal clip 21 is made of a nickel-titanium alloy with superelasticity, and the distal clip 23 is made of stainless steel or cobalt-chromium alloy with higher hardness.

[0038] Preferably, the first coating 31 extends to wrap the edge of the proximal clip 21, and the second coating 32 extends to wrap the edge of the distal clip 23. The coverage rate of the proximal clip 21 by the first coating 31 is in the range of 50% to 90%, and the coverage rate of the distal clip 23 by the second coating 32 is in the range of 40% to 80%, so as to avoid the edges of the proximal clip 21 and the distal clip 23 from damaging the valve tissue.

[0039] In the present invention, by providing a first coating 31 and / or a second coating 32 on at least a portion of the surface of the proximal clip 21 and / or the distal clip 23 of the clamp 20, at least a portion of the metal surface and / or the metal sharp edge of the proximal clip 21 and / or the distal clip 23 can be wrapped to prevent at least a portion of the metal surface and / or the metal sharp edge of the clamp 20 from directly contacting the valve tissue clamped in the valve accommodating space 25, thereby reducing or avoiding tissue allergies, inflammatory reactions, and damage to the clamped valve tissue.

[0040] For details, please refer to Figures 6 to 8 , the push rod 10 is a rod-shaped body or a tubular body. In this embodiment, the push rod 10 is a round rod body, and a ring groove 11 is circumferentially provided on the proximal end of the outer circumference of the push rod 10, and an internal threaded hole 13 is axially provided on the proximal end surface of the push rod 10. A connecting seat 15 is provided at the distal end of the push rod 10, and the connecting seat 15 includes two opposite first planes and a side surface connecting the two first planes. A through pin hole is provided on the two opposite first planes. The side surface includes a curved surface located at the distal end and a second plane located at the proximal end and connected to the curved surface. The distal end of the push rod 10 is vertically fixed on the second plane, and the area of ​​the second plane is larger than the cross-sectional area of ​​the push rod 10. The cross-sectional dimension of the connecting seat 15 parallel to the second plane direction gradually decreases from the proximal end to the distal end, that is, the shape of the connecting seat 15 can be a hemispherical body, a spherical crown, a bullet-shaped structure, etc., so that the valve clip 100 is easier to be pushed in the body.

[0041] The outer surfaces of the push rod 10 and the connecting seat 15 are smooth to avoid damaging the valve leaflets or hooking the chordae tendineae.

[0042] The push rod 10 and the connecting seat 15 are made of biocompatible materials such as stainless steel, cobalt alloy, cobalt-chromium alloy or titanium alloy, preferably stainless steel or cobalt-chromium alloy.

[0043] For further information, please also refer to Figure 6 , Figure 7 and Fig. 9 The valve clipper 100 further includes a fixed base 40, which includes a first base body 41 and a second base body 42 connected to the distal end of the first base body 41. The first base body 41 and the second base body 42 can be an integral structure or a non-integrated structure. In this embodiment, the first base body 41 and the second base body 42 are an integral structure.

[0044] In this embodiment, the first seat body 41 is a circular tube body with openings at both ends, and the push rod 10 is arranged in the tube cavity of the first seat body 41. An opening 411 is provided on the outer wall of the first seat body 41 near the distal end, and a spring piece 413 is arranged in the opening 411. The spring piece 413 includes a connecting end and a free end opposite to the connecting end, the connecting end is connected to the proximal edge of the opening 411, and the free end extends to the inner cavity of the circular tube body. That is to say, in a natural state, the free end of the spring piece 413 is inclined toward the tube cavity of the first seat body 41 relative to the connecting end. A connecting portion 415 is provided at the proximal end of the first seat body 41, and the connecting portion 415 is used to connect with a pushing device for pushing the valve clip 100 to the heart valve. In this embodiment, the connecting portion 415 is at least a pair of T-shaped grooves provided on the outer wall of the first seat body 41. Preferably, the at least one pair of T-shaped grooves are arranged symmetrically with the axis of the first seat body 41 as the axis, and each T-shaped groove includes a first groove section and a second groove section perpendicularly intersecting the first groove section. The second slot section is located at the distal end of the first slot section. The extending direction of the first slot section is the same as the axial direction of the first seat body 41 , and the proximal end of the first slot section passes through the proximal end surface of the first seat body 41 .

[0045] In this embodiment, the second seat body 42 includes two spaced-apart clamping plates 421, which are connected by two connecting rods 423. The two connecting rods 423 are spaced-apart, and the two connecting rods 423 and the two clamping plates 421 form a through-channel 425, which corresponds to the lumen of the first seat body 41. The push rod 10 can be inserted into the lumen of the first seat body 41 and can move axially. Furthermore, the two opposite ends of the two clamping plates 421 are also provided with fixing holes 427.

[0046] The penetration channel 425 may be a square channel or a circular channel. In this embodiment, the penetration channel 425 is a square channel.

[0047] It is understandable that only one embodiment of the fixed base 40 is provided here. In fact, the fixed base 40 may also be other structures, which will not be described in detail here.

[0048] Please also read Figure 5 and Fig.10 The proximal clip 21 includes a connecting end 211 and a free end 212 that are arranged opposite to each other, and the connecting end 211 is fixed to the fixed base 40. In this embodiment, the connecting ends 211 of the two proximal clips 21 are connected as a whole through a connecting piece 213, and a through hole is provided in the connecting piece 213. The middle part of the connecting piece 213 is fixedly connected to the connection between the first base body 41 and the second base body 42 to achieve the fixation of the connecting ends 211 of the two proximal clips 21 and the fixed base 40, and the through hole of the connecting piece 213 corresponds to the inner cavity of the first base body 41. Obviously, in other embodiments, the connecting end 211 of the proximal clip 21 can be directly fixed to the connection between the first base body 41 and the second base body 42.

[0049] Among them, the proximal clip 21 is at least partially made of an elastic material with shape memory function. After heat setting treatment, in the natural state, the proximal clip 21 is in an unfolded U-shape, that is, the proximal clip 21 and the push rod 10 are set at an angle so as to cooperate with the distal clip 23 to clamp the valve tissue. The angle between the two sides of the proximal clip 21 is in the range of 0-200 degrees. In this embodiment, the proximal clip 21 is cut from nickel-titanium alloy and placed in a shaping mold, and then the shaping mold is placed in an electrically heated circulating air box furnace, and a shaping heat treatment is performed at 300-650°C, and then taken out and quickly placed in purified water for cooling, and the shaping mold is removed to obtain the shaped proximal clip 21. Specifically, in this embodiment, the proximal clip 21 is made of nickel-titanium alloy as a whole, so as to provide elastic force for the proximal clip 21 to drive the proximal clip 21 to move closer to the distal clip 23 to clamp the valve tissue. In other embodiments, the connecting end 211 of the proximal clip 21 is made of elastic material, and the free end 212 of the proximal clip 21 can be made of non-elastic material such as aluminum alloy, and the elastic force of the connecting end 211 drives the proximal clip 21 to move closer to the distal clip 23.

[0050] It should be noted that the free end 212 of the proximal clip 21 extending outward and radiating toward the proximal end relative to the push rod 10 can be controlled by an adjustment line. In the delivery state, the free end 212 of the proximal clip 21 is tightened by the adjustment line and fits onto the surface of the fixed base 40 and is close to the push rod 10. After the control of the free end 212 by the adjustment line is released, the connecting end 211 of the proximal clip 21 rebounds due to its own elastic memory properties, and the proximal clip 21 returns to its natural state and presses the valve toward the distal clip 23. Preferably, the angle between the two side extension directions of the proximal clip 21 in the naturally expanded state should be slightly larger than the angle between the two distal clips 23 to provide a more stable clamping force, that is, the angle between the extension direction of each side of the proximal clip 21 and the push rod 10 is larger than or equal to the angle between the distal clip 23 and the push rod 10 when the distal clip 23 corresponding to that side is opened to the maximum state, thereby ensuring that there is a certain clamping force between the distal clip 23 and the proximal clip 21 to clamp the valve tissue between the distal clip 23 and the proximal clip 21.

[0051] Further, the proximal clip 21 also includes a first surface 214 facing the distal clip 23 and the valve accommodating space 25 and a second surface 215 away from the first surface 214. A clamping reinforcement 216 is provided on the first surface 214 to increase the friction between the proximal clip 21 and the valve tissue clamped in the valve accommodating space 25, thereby improving the clamping force of the valve clip 100 on the valve tissue. Specifically, in this embodiment, the clamping reinforcement 216 is two rows of barbs arranged at intervals on opposite sides of the first surface 214. The barbs can be formed on the proximal clip 21 in an integrated manner, or the barbs can be formed of the same or different materials as the proximal clip 21 and then connected to the first surface 214 of the proximal clip 21. For example, a nickel-titanium wire or a nickel-titanium rod can be fixed to the first surface 214 through a sleeve. The root of the barb is connected to the proximal clip 21, and the end of the barb opposite to the root is a suspended end. In the naturally expanded state, the suspended end of the barb faces the distal clip 23. The angle between the extension direction of the barb and the first surface 214 is less than or equal to 90 degrees, so as to enhance the clamping force of the valve clip 100 on the valve tissue. Furthermore, the suspended end of each barb is a smooth arc surface, so as to avoid damaging the valve tissue.

[0052] In other embodiments, the number of barbs may be 1, 2, or other reasonable numbers.

[0053] In other embodiments, the clamping reinforcement 216 may be a ridge, a boss or other irregularly distributed protrusions protruding from the first surface 214, or may be a rough surface at least partially covering the first surface 214 to increase the clamping force on the valve tissue.

[0054] Among them, multiple openings are opened on the proximal clip 21 to reduce the weight of the proximal clip 21, to prevent the overweight clamp 10 from falling under the valve leaflet for a long time and causing slippage or damage to the valve leaflet, and at the same time it is also beneficial to the climbing and growth of endothelial cells.

[0055] Please also read Figures 5 to 7 The valve clip 100 includes two distal clips 23 that are axially symmetrically arranged relative to the push rod 10. Each distal clip 23 includes a connecting section 231 located at the distal end and a clamping section 232 arranged at the proximal end of the connecting section 231. The proximal end of the connecting section 231 is rotatably connected to the second seat body 42 of the fixed base 40, and the distal end of the connecting section 231 is movably connected to the connecting seat 15 of the push rod 10. In this embodiment, each distal clip 23 is rotatably connected to the second seat body 42 of the fixed base 40 through a first pin 51. The two distal clips 23 are located at opposite ends of the first seat body 42. The distal ends of the two distal clips 23 intersect and are movably connected to the connecting seat 15 of the push rod 10 through the same second pin 52.

[0056] In other embodiments, the first pin 51 and / or the second pin 52 may be replaced by a bolt.

[0057] In this embodiment, the connecting section 231 of each distal clip 23 includes two connecting pieces spaced opposite to each other, a connecting hole is provided at the proximal end of each connecting piece, and a slide groove is provided at the distal end of each connecting piece, and the slide groove extends from the distal end of the connecting piece to the proximal end. Obviously, in other embodiments, the connecting section 231 may include only one connecting piece.

[0058] Specifically, one end of the first pin 51 first passes through the connecting hole on the connecting plate on one side of the distal clip 23, then passes through the corresponding fixing hole 427 of the second base body 42, and finally is inserted into the connecting hole on the connecting plate on the other side opposite to the distal clip 23. A first baffle is welded at the end of the first pin 51 to prevent the first pin 51 from slipping, thereby rotating the proximal end of the connecting section 231 of the distal clip 23 to connect to the second base body 42 of the fixed base 40. The connecting sections 231 of the two distal clips 23 on the same side of the second seat body 42 are stacked on each other, and the sliding grooves of the two connecting sections 231 are connected. One end of the second pin 52 passes through the sliding grooves on the two connecting pieces on the same side of the connecting seat 15 of the two distal clips 23 in sequence, then passes through the pin hole on the connecting seat 15, and finally is inserted into the sliding grooves on the two connecting pieces on the other side opposite to the connecting seat 15 of the two distal clips 23. A second baffle is welded at the end of the second pin 52 to prevent the second pin 52 from slipping off, so that the distal ends of the connecting sections 231 of the two distal clips 23 are movably connected to the connecting seat 15 of the push rod 10 through the same second pin 52.

[0059] When the push rod 10 moves axially in the tubular cavity of the penetration channel 425 and the first seat body 41, the second pin 52 penetrated in the pin hole of the connecting seat 15 can slide in the slide groove on the connecting plate of the distal clip 23, thereby driving the distal clip 23 to rotate around the first pin 51 with the connection position of the proximal end of its connecting section 231 connected to the second seat body 42 as the rotation center. The clamping section 232 of the distal clip 23 opens and closes relative to the fixed base 40 and the push rod 10. When the proximal clip 21 is released and freely unfolded due to its own elastic memory function, it can move closer to the distal clip 23 to clamp the valve tissue.

[0060] Furthermore, the distal clip 23 also includes a third surface 233 facing the proximal clip 21 and the valve accommodating space 25 and a fourth surface 234 facing away from the third surface 233 . The third surface 233 is opposite to the first surface 214 of the proximal clip 21 .

[0061] The third surface 233 can be a plane or a curved surface. In this embodiment, the third surface 233 is a curved surface, and the curvature direction of the curved surface is toward the proximal clip 21. By setting the third surface 233 as a curved surface, the contact area and clamping area between the distal clip 23 and the valve tissue can be increased, thereby providing a stable clamping force. Moreover, the curved third surface 233 forms a receiving groove, and when the proximal clip 21 moves closer to the distal clip 23, the barbs on the first surface 214 of the proximal clip 21 can be received in the receiving groove to compress the leaflets located in the leaflet accommodating space 25, or minimize the volume of the valve clip 100 when it is folded, so that the valve clip 100 is easier to be transported in the body.

[0062] The third surface 233 may be provided with a clamping enhancement structure, which may be a protrusion, a groove, or a gasket made of a biocompatible material with a high friction coefficient attached to the third surface 233. By providing a protrusion, a groove, or a gasket on the third surface 233, the friction between the distal clip 23 and the valve tissue can be enhanced, thereby providing a stable clamping force.

[0063] Please also read Figure 3 and Figure 6 In the present invention, in order to prevent the metal surface and / or metal sharp edge of the valve clip 100 from damaging the clamped valve tissue, the valve clip 100 is covered with a coating 30. Specifically, in this embodiment, the coating 30 includes a first coating 31 covering the proximal clip 21 and a second coating 32 covering the distal clip 23.

[0064] The first coating 31 at least completely covers the first surface 214 of the proximal clip 21, and the second coating 32 at least completely covers the third surface 233 of the distal clip 23. Preferably, in this embodiment, the first coating 31 completely covers the first surface 214 and extends to completely cover the second surface 215, and the second coating 32 completely covers the third surface 233 and extends to completely cover the fourth surface 234.

[0065] In other embodiments, the first coating 31 may extend to cover a portion of the second surface 215 , and the second coating 32 may extend to cover a portion of the fourth surface 234 , so as to reduce the amount of coating and lower the cost.

[0066] The first coating 31 and the second coating 32 are made of at least one layer of biocompatible polymer material that is biocompatible, anti-oxidant, and anti-dissolution, and the polymer material is selected from at least one of PET, polyester, PTFE, silicone resin, silica gel, or urethane. Further, the materials of the first coating 31 and the second coating 32 can be the same or different. In this embodiment, the first coating 31 and the second coating 32 are preferably single-layer PET coatings.

[0067] The first coating 31 and the second coating 32 are fixed by any method such as suturing, dipping, bonding, fusion or bundling. In this embodiment, the first coating 31 is bonded and fixed to the proximal clip 21, and the second coating 32 is sutured and fixed to the distal clip 23.

[0068] In this embodiment, the two surfaces of the valve clamp 100 facing the valve accommodating space 25 and its edges are completely wrapped by the coating 30, and the valve tissue clamped in the valve accommodating space 25 will not directly contact the metal part of the clamp 20, thereby avoiding tissue allergies, inflammatory reactions, pinching or scratching of the valve tissue in the valve accommodating space 25.

[0069] In other embodiments, the valve clamp 100 may only be covered with the first coating 31 or the second coating 32, that is, one of the side surfaces of the valve clamp 100 facing the valve accommodating space 25 and its edge are completely wrapped by the coating 30. Specifically, the side surface of the proximal clip 21 facing the valve accommodating space 25 is covered with the first coating 31, or the side surface of the distal clip 23 facing the valve accommodating space 25 is covered with the second coating 32, which can also reduce valve tissue damage.

[0070] like Figure 3 and Figure 4As shown in the figure, in this embodiment, the second coating 32 covering the two distal clips 23 also covers the outer surface of the connecting portion of the two distal clips 23 (i.e., the portion where the second seat body 42 and the connecting seat 15 of the push rod 10 are located), thereby wrapping the sharp metal edge of the connecting portion to prevent the sharp metal edge of the connecting portion from damaging the valve tissue or the inner wall of the blood vessel during the process of pushing the valve clamp 100.

[0071] Of course, in other embodiments, the connecting portion may not be covered by the second coating 32 .

[0072] Furthermore, the coating 30 is provided with functional drugs by treatment methods such as biological modification, dipping, brushing, dripping or spraying. For example, the surface of the first coating 31 can be applied with anticoagulants such as heparin by dipping, spraying, etc., or the surface of the first coating 31 can be bio-modified to give it antithrombin properties. A drug coating can also be applied to the first coating 31, and the drug coating contains at least one of anticoagulant drugs, antiplatelet drugs or anti-tissue proliferation drugs, thereby promoting endothelialization, avoiding excessive tissue proliferation, reducing the incidence of corresponding complications, and improving postoperative survival rate. Similarly, the second coating 32 can also be provided with corresponding functional drugs, which will not be repeated here.

[0073] See also Fig.11 After the proximal clip 21 covers the first coating 31, the suspended end of the barb 216 will pierce through and extend out of the first coating 31 to clamp the valve tissue. Preferably, the thickness of the first coating 31 covering the area near the barb 216 is greater than the thickness of the first coating 31 covering other areas of the proximal clip 21, so as to avoid the suspended end of the barb 216 passing through the first coating 31 for too long and penetrating too deeply into the valve tissue, thereby causing damage to the valve tissue.

[0074] The length of the suspended end of the barb protruding from the first coating 31 is 0.2 mm to 2 mm, preferably 0.5 mm to 1 mm.

[0075] It is understandable that when the proximal clip 21 is not covered with the first coating 31, the sharp metal edges caused by processing are exposed, and more exposed sharp edges are likely to cause damage to the valve tissue. Fig.12 and Fig.13In the present invention, after the proximal clip 21 covers the first coating 31, most of the sharp metal edges are covered in the first coating 31, and only the suspended ends of the barbs are exposed, which can ensure the clamping force on the valve tissue without causing serious damage to the valve tissue. Furthermore, when the barbs 216 clamp the valve tissue, the first coating 31 as a whole will have a certain hindering and controlling effect on the penetration of the barbs 216, which can effectively control the depth of the barbs 216 penetrating the valve tissue and reduce the excessive damage to the valve caused by uneven force. In addition, in some extreme cases, once the valve is punctured by the barbs 216, the first coating 31 will immediately cover the puncture site. The polymer material of the first coating 31 has a high degree of biocompatibility. Combined with the effect of the functional drugs on the first coating 31, it can promote the growth of tissue near the puncture site, thereby quickly blocking the puncture hole, preventing blood from seeping into the pericardial cavity, and reducing the risk of pericardial effusion or even cardiac arrest.

[0076] Similarly, after the second coating 32 is added to the distal clip 23 , most of the metal surface is covered in the second coating 32 , thereby preventing the distal clip 23 from causing serious damage to the valve tissue.

[0077] In addition, the first covering film 31 and the second covering film 32 can also play a buffering role, so that the clamped valve tissue is evenly stressed, thereby avoiding damage to the valve tissue caused by excessive local stress.

[0078] As mentioned above, in this embodiment, the valve clip 100 can be used to alleviate or treat "mitral regurgitation". Figures 14 to 16 The valve clip 100 is placed at the position where the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve cannot be normally aligned, so that one distal clip 23 and one side of the proximal clip 21 clamp the edge of the anterior leaflet 1a of the mitral valve, and the other distal clip 23 and one side of the proximal clip 21 clamp the edge of the posterior leaflet 1b of the mitral valve, so as to clamp the position where the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve cannot be normally aligned together, and the coating 30 on the valve clip 100 can prevent the mitral valve from being clamped or scratched. Fig.15 As shown in , when the heart contracts, the anterior leaflet 1a and the posterior leaflet 1b close together, and the positions where the anterior leaflet 1a and the posterior leaflet 1b cannot normally close together are partially or completely closed, and the area A of the mitral valve opening becomes smaller or the mitral valve can be completely closed, and only a small amount of blood flows back from the mitral valve opening into the left atrium, thereby alleviating or treating "mitral valve regurgitation". Fig.16 As shown in FIG, when the heart is in diastole, the anterior leaflet 1a and the posterior leaflet 1b are only clamped together at position B where the valve clamp 100 is clamped, and the other positions of the anterior leaflet 1a and the posterior leaflet 1b are still normally relaxed, so that blood can enter the left ventricle from the left atrium, thereby ensuring the normal circulation of blood.

[0079] in, Fig.15 and Fig.16 The arrows shown in the figure are the direction of blood flow.

[0080] The coating 30 may allow blood to penetrate therethrough or not. Preferably, in this embodiment, the first coating 31 and the second coating 32 may allow blood to penetrate therethrough to increase the resistance force of blood circulation, thereby reducing the blood pressure difference between the left atrium and the left ventricle.

[0081] For details, please refer to Figure 3 and Figure 4 The membrane 30 adopts one or more structures selected from the group consisting of a two-dimensional sieve structure, a porous membrane, a microporous structure, a woven or non-woven mesh structure, and a foam structure, so that blood can penetrate and flow through the membrane 30. In this embodiment, the first membrane 31 and the second membrane 32 both adopt a woven mesh structure, and both have a plurality of mesh holes.

[0082] The porosity of the first coating 31 is smaller than the porosity of the second coating 32 .

[0083] The porosity refers to the percentage of the opening area to the entire coating area.

[0084] The second coating 32 has a larger opening rate, so that the second coating 32 has better elasticity and elongation than the first coating 31. When the distal clip 23 covered with the second coating 32 opens and closes relative to the push rod 10, the second coating 32 can follow the opening and closing of the distal clip 23 and produce corresponding elastic deformation. The second coating 32 is always attached to the distal clip 23.

[0085] The number of meshes per inch of the first coating 31 ranges from 250 meshes to 2500 meshes, and the number of meshes per inch of the second coating 32 ranges from 24 meshes to 250 meshes. In this embodiment, the number of meshes per inch of the first coating 31 is preferably 500 meshes to 2500 meshes, and the number of meshes per inch of the second coating 32 is preferably 50 meshes to 150 meshes.

[0086] The mesh holes on the first coating 31 and the second coating 32 can pass blood and prevent thrombus from passing through. Further, the aperture of the mesh holes of the first coating 31 is smaller than the aperture of the mesh holes of the second coating 32. Specifically, the aperture of the mesh holes of the first coating 31 ranges from 0.01 mm to 0.1 mm, and the aperture of the mesh holes of the second coating 32 ranges from 0.2 mm to 0.5 mm. In this embodiment, the aperture of the mesh holes of the first coating 31 preferably ranges from 0.01 mm to 0.05 mm, and the aperture of the mesh holes of the second coating 32 preferably ranges from 0.2 mm to 0.5 mm.

[0087] Preferably, in some embodiments, the aperture of the mesh of the second coating 32 arranged in the direction from the proximal end to the distal end of the distal clamp 23 gradually increases, that is, the mesh density of the second coating 32 covering the proximal region of the distal clamp 23 (that is, the clamping section 232) is higher than the mesh density of the second coating 32 covering the distal region of the distal clamp 23 (that is, the connecting section 231).

[0088] Specifically, Figure 3 and Figure 4 As shown in, in the present embodiment, the mesh size of the second coating 32 covering the proximal region of the distal clip 23 (i.e., the clamping section 232) is relatively small, and the second coating 32 in this region has a high density, so it is not easily worn through by the proximal edge of the distal clip 23 and will not affect the opening and closing of the distal clip 23; while the mesh size of the second coating 32 covering the distal region of the distal clip 23 (i.e., the connecting section 231) is relatively large, and the elasticity and elongation of the second coating 32 in this region are better, even in the case of some large opening and closing angles, the second coating 32 close to the push rod 10 can also deform accordingly with the opening and closing of the distal clip 23, to ensure that the second coating 32 is attached and fixed to the distal clip 23.

[0089] In the present invention, the first coating 31 is provided with a plurality of mesh holes, so that the first coating 31 can allow blood to penetrate through, without affecting the normal flow of blood from the left atrium to the left ventricle, and preventing blood from being retained in the left atrium, thereby reducing the damage of the left atrial cavity caused by blood pressure; moreover, the number and aperture of the mesh holes of the first coating 31 are reasonably set, and the first coating 31 can also form an artificial barrier on the atrial side of the valve leaflet to block the thrombus in the blood, close the opening of the entire valve clamp 100 toward the atrial side, and prevent the thrombus from entering the interior of the valve clamp 100 or the left ventricle, thereby preventing the valve clamp 100 from falling off or the thrombus from entering the left ventricle from the left atrium and then entering the human body's blood circulation through the aorta; in addition, because the first coating 31 blocks the thrombus from entering between the first coating 31 and the distal clip 23, the impact force of the thrombus on the distal clip 23 is reduced, the service life of the distal clip 23 is extended, and the service life of the valve clamp 100 is increased. At the same time, the first coating 31 can also increase the contact area between the proximal clip 21 and the blood to buffer the incoming blood flow, thereby preventing the incoming blood flow from impacting the valve clamp 100 and causing the proximal clip 21 to deform and slip.

[0090] Similarly, in the present invention, the second coating 32 with multiple mesh holes can allow blood to flow normally in the left atrium and between the left ventricle, thereby reducing the blood pressure difference between the left atrium and the left ventricle; furthermore, the second coating 32 can also block a very small amount of thrombus that enters the interior of the valve clamp 100 through the first coating 31 and retain it in the valve clamp 100, preventing the thrombus from entering the left ventricle and entering the human blood circulation to induce a stroke.

[0091] It should be noted that static friction refers to the resistance that hinders relative sliding between two objects when their contact surfaces tend to slide relative to each other but remain relatively still. This resistance is called static sliding friction, or static friction for short, and is generally represented by F. The magnitude of static friction can be between 0 and F. MAX Changes between MAX is the maximum static friction force, which is approximately equal to the sliding friction force f. The magnitude of the sliding friction force f is proportional to the positive pressure N, that is, f = μN. μ is the dynamic friction coefficient, which is related to the material, roughness and elastic force between the contact surfaces. For the valve clamp 100 implanted on the leaflet, the first surface 214 of the proximal clip 21 facing the distal clip 23 contacts the upper surface of the leaflet, and the third surface 233 of the distal clip 23 facing the proximal clip 21 contacts the lower surface of the leaflet. Since the leaflet tissue is sticky and the surface is full of blood and is in constant high-speed motion, there is always a tendency of relative sliding between the first surface 214 of the proximal clip 21 and the upper surface of the leaflet, and between the third surface 233 of the distal clip 23 and the lower surface of the leaflet. In order to avoid sliding or even falling off between the clamp and the leaflet, the prior art only adopts the method of adding barbs, friction pads or simply increasing the contact area of ​​the leaflet to avoid sliding. In the present embodiment, a first coating 31 with a denser density and a smaller porosity is coated on the proximal clip 21 with an elastic memory function, and a second coating 32 with a sparser density and a larger porosity is coated on the distal clip 23 made of a rigid material. When the valve clamp 100 is affected by the flushing of blood flow and the beating of the valve leaflets, and the positive pressure N remains unchanged, the dynamic friction coefficient μ between the first surface 214 of the proximal clip 21 and the upper surface of the valve leaflet, and between the third surface 233 of the distal clip 23 and the lower surface of the valve leaflet are increased, which not only increases the two friction forces respectively, but also makes the two match each other to achieve a dynamic balance under the force state, thereby further improving the clamping force and stabilizing force of the valve clamp 100.

[0092] See also Fig.17 and Fig.18The present invention also provides a valve clamping system, which includes a pushing device and the aforementioned valve clamp 100. The valve clamp 100 can be delivered to the mitral valve by the pushing device, and the valve clamp 100 can be adjusted to a suitable position of the mitral valve. The pushing device includes an operating handle and a pushing assembly, the proximal end of the pushing assembly is connected to the operating handle, and the distal end of the pushing assembly is detachably connected to the valve clamp 100. Specifically, the pushing assembly includes a core shaft 210, a liner 220, and an outer tube 230 that are coaxially sleeved together, and the liner 220 is located between the core shaft 210 and the outer tube 230. The operating handle can drive the core shaft 210, the liner 220, and the outer tube 230 to move relative to each other.

[0093] The distal end of the mandrel 210 has an external thread 211 corresponding to the internal thread in the internal thread hole 13 at the proximal end of the push rod 10. When the push assembly 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 10, and the mandrel 210 is driven to move by the operating handle, thereby realizing the axial movement of the push rod 10.

[0094] A T-shaped spring piece 231 is provided at the distal end of the outer tube 230, which is used to cooperate with the connecting portion 415 (i.e., the T-shaped groove) at the proximal end of the first seat body 41 to achieve connection and unlocking of the outer tube 230 and the first seat body 41. In the natural state, one end of the T-shaped spring piece 231 is connected to the distal end of the outer tube 230, and the other end is inclined toward the axial position of the outer tube 230. Specifically, when the push assembly is connected to the valve clamp 100, the core shaft 210 is threadedly connected to the push 10, and the operating handle drives the liner 220 to move so that the liner 220 extends into the tubular cavity of the first seat body 41, and 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 groove of the first seat body 41. At this time, the first seat body 41 and the outer tube 230 are in a connected state; when the operating handle is operated to make the liner 220 leave the first seat body 41, the T-shaped spring piece 231 of the outer tube 230 returns to its natural state, that is, it deforms inward and disengages from the T-shaped groove at the proximal end of the first seat body 41, so that the first seat body 41 and the outer tube 230 are unlocked.

[0095] The pushing device further includes a control member, which is the aforementioned adjustment wire, for binding the free end 212 of the proximal clip 21 to the surface of the fixed base 40 and close to the push rod 10. The adjustment wire can be made of metal or polymer materials such as PTFE.

[0096] 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:

[0097] Step 1: Use the adjustment line to tie the free end 212 of the proximal clip 21 to the surface of the fixed base 40, and then connect the push assembly to the valve clip 100. Specifically, rotate the core shaft 210 of the push assembly so that the core shaft 210 is fixed to the push rod 10. 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 of the first seat body 41, so that the first seat body 41 and the outer tube 230 are in a connected state. In addition, at this time, the free end of the spring piece 413 on the first seat body 41 is located in the annular groove 11 of the push rod 10, so that the distal clip 23 and the proximal clip 21 are both close to the surface of the push rod 10 and remain unchanged.

[0098] Step 2: Using the trans-atrial septal approach, the valve clipper 100 connected thereto is pushed from the left atrium through the mitral valve to the left ventricle via the pushing assembly.

[0099] Step 3: Adjust the relative position of the valve clamp 100 and the mitral valve by using the pushing assembly so that the valve clamp 100 is close to the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve.

[0100] Step 4: Further move the liner 220 axially toward the distal end, so that the liner 220 lifts up the free end of the spring piece 413 of the first seat body 41, so that the free end of the spring piece 413 is separated from the annular groove 11 at the proximal end of the push rod 10. At this time, the push rod 10 can move axially to drive the distal clip 23 to open and close relative to the push rod 10.

[0101] Step 5: Move the core shaft 210 in the proximal direction by operating the handle, thereby driving the push rod 10 connected to the core shaft 210 to move in the proximal direction, so as to drive the distal clip 23 to open relative to the push rod 10.

[0102] Step 6: Adjust the direction of the valve clip 100 so that the distal clip 23 is perpendicular to the coaptation line of the mitral valve.

[0103] Step 7: Withdraw the entire valve clamp 100 proximally so that the distal clip 23 holds the valve leaflet on the left ventricle side; release the restraint of the adjustment line on the proximal clip 21, and the proximal clip 21 rebounds and opens relative to the push rod 10, so that the valve leaflet is clamped between the proximal clip 21 and the distal clip 23, that is, the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve are respectively clamped between a group of proximal clips 21 and distal clips 23.

[0104] Step 8: Move the core shaft 210 toward the distal direction, and the core shaft 210 drives the push rod 10 to move axially toward the distal end, thereby driving the distal clip 23 to close relative to the push rod 10 until it is completely retracted.

[0105] Step 9: The outer tube 230 is fixed and the liner 220 is retracted toward the proximal end for a certain distance. At this time, the free end of the spring piece 413 of the first seat body 41 is inserted into the annular groove 11 of the push rod 10 to lock the push rod 10 and ensure that the distal clip 23 is always retracted. The core shaft 210 is controlled to rotate by the operating handle so that the thread between the core shaft 210 and the push rod 10 is unlocked. The liner 220 and the core shaft 210 are retracted toward the proximal end until the T-shaped spring piece 231 of the outer tube 230 is unlocked and separated from the T-shaped groove of the first seat body 41. At this time, the valve clamp 100 is completely separated from the pushing assembly. The pushing assembly is withdrawn from the patient's body, and the valve clamp 100 is left in the patient's body to complete the edge-to-edge repair of the mitral valve leaflets. Fig.14 As shown, the proximal clip of the valve clamp 100 is fixed on the atrial side of the valve leaflet, and the first coating 31 contacts the atrial side of the valve leaflet, thereby isolating the direct contact between the proximal clip 21 and the valve leaflet, increasing the friction force of the metal proximal clip 21 on the valve leaflet, making the force more uniform, and making the force on each barb uniform, thereby avoiding damage to the valve leaflet due to excessive penetration or uneven force or excessive force; at the same time, the second coating 32 can improve the adhesion of the distal clip 23 to the valve wall and increase the contact area between the distal clip 23 and the valve; it plays a buffering role on the surface of the distal clip 23, thereby avoiding direct contact between the metal and the valve, reducing the effect of mechanical force on the valve and thus avoiding inflammatory response.

[0106] It is understandable that the valve clipping system of the present invention may also deliver the valve clipper to the mitral valve via a transapical route or the like.

[0107] The valve clamping system of the present invention can be operated in vitro to clamp the valve leaflets with the valve clamp 100, thereby reducing or avoiding the problem of "mitral regurgitation". In addition, the covering 30 of the valve clamp 100 can reduce or avoid damage to the clamped valve tissue, and can also avoid damage to the valve tissue or other vascular tissue during the pushing process.

[0108] See also Fig.19 and Fig. 20 , shows a valve clipper 100a of another embodiment of the present invention, which includes a push rod 10a, a distal clip 23a axially symmetrically arranged on the outer surface of the push rod 10a and capable of opening and closing relative to the push rod 10a, a proximal clip 21a for clamping and fixing the valve leaflet in cooperation with the distal clip 23a, a first coating 31a covering the proximal clip 21a, and a second coating 32a covering the distal clip 23a. When the distal clip 23a is closed with the push rod 10a, it can be delivered to the vicinity of the patient's valve through a sheath. The structures of the proximal clip 21a and the first coating 31a are the same as those of the proximal clip 21 and the first coating 31 of the valve clipper 100 in the first embodiment, and will not be repeated here.

[0109] The connecting seat 15a is located at the distal end of the push rod 10a, and a circular hole is provided at the proximal end of the connecting seat 15a for connecting the push rod 10a by means of threading, welding, etc. Pin holes are provided on both sides of the connecting seat 15a, and a pair of connecting rods 16a are connected by pin hinges, that is, each connecting rod 16a is connected to the connecting seat 15a through a hinge connection and rotates relative to the connecting seat 15a. The other end of the connecting rod 16a is connected to the distal clip 23a by a pin. The fixed base 40a is sleeved on the outside of the push rod 10a, and the push rod 10a can move along its axial direction, thereby realizing the movement between the connecting seat 15a and the fixed base 40a, and then driving the opening and closing of the distal clip 23a relative to the push rod 10a. See Fig.21 In this way, a larger range of opening angles can be achieved, and the angle between the two distal clips 23a can reach a maximum of 320 degrees. The preferred opening angle is from 0 to 270 degrees, and further preferably from 120 to 180 degrees. That is, after the distal clip 23a is opened relative to the push rod 10a, it can be flipped downward to a certain extent. Due to the elastic retraction function of the second coating 32a, when the distal clip 23a is opened, the second coating 32a can adapt to the deformation and open without obvious resistance, thereby facilitating the clamping of the leaflet that is constantly in motion and improving the clamping success rate.

[0110] Fig. 22 FIG. 1 is a valve clip 100b provided by another embodiment of the present invention. Figure 3 The difference between the illustrated embodiments is that the valve clip 100b comprises a V-shaped proximal clip 21b and a distal clip 23b. Driven by the push rod 10b, the proximal clip 21b and the distal clip 23b move relative to each other and overlap to clamp the two leaflets.

[0111] The side surface of the proximal clip 21b facing the distal clip 23b and the side surface of the distal clip 23b facing the proximal clip 21b are at least partially covered with the coating 30b.

[0112] Specifically, each proximal clip 21b is covered with a first coating 31b, each distal clip 23b is covered with a second coating 32b, and the connecting portion between the two distal clips 23b is also covered with the second coating 32b.

[0113] It can be understood that the connection portion between the two proximal clips 21b can also be covered with the first coating 31b.

[0114] The first coating 31 b and the second coating 32 b have the same structures and functions as the aforementioned first coating 31 and the second coating 32 , and are not described in detail herein.

[0115] It is understandable that the valve clamps 100a and 100b and the pushing device can also form a valve clamping system, and the usage steps are the same as those mentioned above and will not be repeated here.

[0116] It should be noted that the above contents are all described by taking the valve clip 100 for alleviating or treating "mitral valve regurgitation" as an example. It is understandable that in other embodiments, the valve clip 100 can also be used to alleviate or treat "tricuspid valve regurgitation", and its principle and structure are roughly the same as the principle and structure of the valve clip 100 for solving "mitral valve regurgitation" in the embodiment of the present invention, and it only needs to form multiple clamps through multiple groups of proximal clips and distal clips, and each clamp clamps a valve leaflet respectively, which will not be described in detail here.

[0117] Obviously, in other embodiments, the valve clipper 100 provided by the present invention can also be applied to other minimally invasive surgical operations that require clamping three or more pieces of valve tissue together.

[0118] The above is an implementation of the embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the embodiment of the present invention. These improvements and modifications are also considered to be within the scope of protection of the present invention.

Claims

1. A valve clip with a membrane, characterized in that: include: Putting; Relative to the proximal clip and the distal clip that are radially expanded by the push rod, the distal clip is connected to the push rod, the proximal clip is arranged between the push rod and the distal clip, a valve accommodating space is formed between the proximal clip and the distal clip, the push rod can drive the distal clip to radially expand, and the proximal clip is close to the distal clip after expanding by its own elasticity to clamp the valve tissue located in the valve accommodating space; as well as A covering film, the covering film comprising a first covering film covering at least one side of the proximal clip facing the valve accommodating space and a second covering film covering at least one side of the distal clip facing the valve accommodating space; Among them, the first coating extends to wrap the edge of the proximal clip, and the second coating extends to wrap the edge of the distal clip. The first coating and the second coating both adopt a mesh structure, and the aperture of the mesh arranged in the second coating in the direction from the proximal end to the distal end of the distal clip gradually increases.

2. The valve clip according to claim 1, characterized in that: The proximal clip is made of an elastic material with shape memory function, and the distal clip is made of a rigid material.

3. The valve clip according to claim 1, characterized in that: The coverage rate of the first coating on the proximal clip ranges from 50% to 90%, and the coverage rate of the second coating on the distal clip ranges from 40% to 80%.

4. The valve clip according to claim 1, characterized in that: The proximal clip includes a first surface facing the distal clip, and the first coating at least completely covers the first surface.

5. The valve clip according to claim 4, characterized in that: The proximal clip further includes a second surface facing away from the first surface, and the first coating extends to cover at least a portion of the second surface.

6. The valve clip according to claim 4, characterized in that: At least one barb is disposed on the first surface, the suspended end of at least one barb faces the distal clip, and at least one barb penetrates through the first coating.

7. The valve clip according to claim 6, characterized in that: The length of the suspended end of the barb protruding from the first coating ranges from 0.2 mm to 2 mm.

8. The valve clip according to claim 6, characterized in that: The thickness of the first coating covering the area near the barb is greater than the thickness of the first coating covering other areas of the proximal clip.

9. The valve clip according to claim 1, characterized in that: The distal clip includes a third surface facing the proximal clip, and the second coating at least completely covers the third surface.

10. The valve clip according to claim 9, characterized in that: The distal clip further includes a fourth surface facing away from the third surface, and the second coating extends to cover at least a portion of the fourth surface.

11. The valve clip according to claim 1, characterized in that: The opening rate of the first coating is smaller than the opening rate of the second coating.

12. The valve clip according to claim 1, characterized in that: The number of mesh holes per inch of the first coating is in the range of 250 to 2500 meshes, and the number of mesh holes per inch of the second coating is in the range of 24 to 250 meshes.

13. The valve clip according to claim 1, characterized in that: The aperture of the mesh of the first coating is smaller than that of the mesh of the second coating; the aperture of the mesh of the first coating ranges from 0.01 mm to 0.1 mm, and the aperture of the mesh of the second coating ranges from 0.2 mm to 0.5 mm.

14. The valve clip according to claim 1, characterized in that: The coating is made of at least one layer of biocompatible polymer material, and the polymer material is selected from at least one of PET, polyester, silicone resin, PTFE, silica gel or urethane.

15. The valve clip according to claim 14, characterized in that: The first coating and the second coating may be made of the same or different materials.

16. The valve clip according to claim 1, characterized in that: The coating is provided with functional drugs by biological modification, dipping, brushing, dripping or spraying.

17. The valve clip according to claim 1, characterized in that: The coating is fixed by suturing, dipping, bonding, fusing or bundling.

18. A valve clamping system, characterized in that: It comprises a pushing device and the valve clamp as described in any one of claims 1 to 17, wherein the pushing device comprises an operating handle and a pushing assembly, the proximal end of the pushing assembly is connected to the operating handle, and the distal end of the pushing assembly is detachably connected to the valve clamp.

19. The valve clipping system according to claim 18, characterized in that: The pushing assembly comprises a core shaft, a liner and an outer tube which are coaxially sleeved together movably, and the liner is located between the core shaft and the outer tube.

20. The valve clipping system according to claim 18, characterized in that: The pushing device further comprises a control member, and the control member is used for fixing the proximal clip to fit the pushing rod.

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