CN211243901U

CN211243901U - Valve clamping device with covering film and valve clamping system

Info

Publication number: CN211243901U
Application number: CN201921231134.9U
Authority: CN
Inventors: 张庭超; 张伟伟; 郑贤章; 王泽涛
Original assignee: Hangzhou Valgen Medtech Co Ltd
Current assignee: Hangzhou Valgen Medtech Co Ltd
Priority date: 2019-07-31
Filing date: 2019-07-31
Publication date: 2020-08-14
Anticipated expiration: 2029-07-31

Abstract

The utility model provides a valve clamping system, which comprises a pushing device and a valve clamping device with a film. The valve binder includes a push rod, a covering membrane, and a proximal clip and a distal clip that are radially deployed relative to the push rod. The far-end clamping piece is connected to the push rod, and the near-end clamping piece sets up between push rod and far-end clamping piece, forms valve accommodation space between near-end clamping piece and the far-end clamping piece, and the push rod can drive the far-end clamping piece radiation expansion, and the near-end clamping piece relies on self elasticity to expand the back and is closed up the far-end clamping piece to press from both sides the valve tissue that is located valve accommodation space. The covering film comprises a first covering film covering at least one side surface of the proximal clip facing the valve accommodating space and/or a second covering film covering at least one side surface of the distal clip facing the valve accommodating space. The utility model also provides a valve clamping device with tectorial membrane. The utility model discloses a cover the tectorial membrane on the at least partial surface of near-end clamping piece and/or distal end clamping piece, can reduce or avoid the damage by the valve tissue of centre gripping.

Description

Valve clamping device with covering film and valve clamping system

Technical Field

The utility model relates to the field of medical equipment, especially, relate to a valve clamping device and valve clamping system with tectorial membrane.

Background

Referring to fig. 1, a mitral valve 1 is a one-way valve between the left atrium 2 and the left ventricle 3 of the heart, and a normal and healthy mitral valve 1 can control blood flow from the left atrium 2 to the left ventricle 3 while preventing blood flow from the left ventricle 3 to the left atrium 2. The mitral valve 1 includes a pair of leaflets, referred to as an anterior leaflet 1a and a posterior leaflet 1 b. The anterior leaflet 1a and the posterior leaflet 1b are fixed to papillary muscles of the left ventricle 3 by chordae tendineae 4. Normally, when the left ventricle of the heart contracts, the edges of the anterior leaflet 1a and the posterior leaflet 1b are completely apposed, preventing blood from flowing from the left ventricle 3 to the left atrium 2. Referring to fig. 2, when the leaflets of the mitral valve or their related structures are organically or functionally changed, such as the chordae tendineae 4 are partially broken, the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1 are not properly aligned, so that when the left ventricle 3 of the heart contracts, the mitral valve 1 cannot be completely closed, resulting in the blood flowing back from the left ventricle 3 to the left atrium 2, thereby causing a series of pathophysiological changes, called "mitral regurgitation".

The existing minimally invasive treatment surgery is characterized in that a valve leaflet clamp is conveyed to a mitral valve through a conveying device, and an anterior leaflet and a posterior leaflet of the mitral valve are clamped simultaneously through relative opening and closing of the clamp, so that the anterior leaflet and the posterior leaflet of the mitral valve are fixed, and the purposes of reducing the gap between the valve leaflets and reducing the backflow of the mitral valve are achieved. However, in the prior art, the distal and proximal jaws of the clip are made of metal material, which may cause tissue irritation or inflammation, and the sharp edges of the metal may also cause pinching or scratching of the valve leaflets, resulting in mitral valve disease.

SUMMERY OF THE UTILITY MODEL

In view of the above, the present invention provides a valve clamping device and a valve clamping system capable of reducing or avoiding damage to valve tissue.

In order to solve the technical problem, the utility model provides a valve clamping device with a film, which comprises a push rod, a film, a near-end clamping piece and a far-end clamping piece which are radially expanded relative to the push rod; wherein, the distal end clamping piece connect in the push rod, the near-end clamping piece set up in the push rod with between the distal end clamping piece, the near-end clamping piece with form valve accommodation space between the distal end clamping piece, the push rod can drive the radiation of distal end clamping piece is expanded, the near-end clamping piece relies on self elasticity to expand the back and is closed up the distal end clamping piece, in order to press from both sides the tight valve tissue that is located in the valve accommodation space, the tectorial membrane is including covering the near-end clamping piece faces at least towards the first tectorial membrane and/or the cover of a side of valve accommodation space the distal end clamping piece faces at least towards the second tectorial membrane of a side of valve accommodation space.

The utility model also provides a valve clamping system, including pusher and foretell valve clamping device, pusher includes operating handle and propelling movement subassembly, the proximal end of propelling movement subassembly with operating handle connects, the distal end of propelling movement subassembly with can dismantle the connection between the valve clamping device.

The utility model provides a valve clamping device and valve clamping system, at least part through the near-end clamping piece at the valve clamping device and/or distal end clamping piece sets up the tectorial membrane on the surface, can wrap up at least part metallic surface and/or sharp limit of metal of near-end clamping piece and/or distal end clamping piece, can prevent valve clamping device's at least part metallic surface and/or sharp limit of metal and the valve tissue direct contact of centre gripping in valve accommodation space to reduce or avoid tissue hypersensitivity and inflammatory reaction, avoid damaging by the valve tissue of centre gripping.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings needed to be used in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to these drawings without creative efforts.

Fig. 1 is a schematic view of a mitral valve in a normal state.

Fig. 2 is a schematic view of a diseased mitral valve.

Fig. 3 is a schematic view of the valve clip device according to one embodiment of the present invention in an open state.

Figure 4 is a schematic view of the valve clip of figure 3 in a closed state.

Fig. 5 is a schematic view of the valve clip of fig. 3 shown without a cover.

Fig. 6 is a schematic view of the structure of fig. 5 from another perspective.

Fig. 7 is a schematic view of the valve holder of fig. 4 shown in an uncoated state.

Fig. 8 is an enlarged schematic view of section VIII in fig. 6.

Fig. 9 is an exploded view of the stationary base of fig. 6.

Fig. 10 is a schematic view of the proximal clip of fig. 6.

Fig. 11 is a schematic view of the proximal clip of fig. 10 covering the first cover film.

Fig. 12 is a schematic view of the distal clip of the valve binder of fig. 3 held under the leaflets.

FIG. 13 is a schematic view of the proximal clip of the valve binder device of FIG. 3 drawn together with the distal clip to hold the valve.

Fig. 14 is a schematic view of the valve clip of fig. 3 in a position in use.

Fig. 15 is a schematic view of the mitral valve of fig. 14 after the valve binder has clamped the leaflets and the heart has contracted.

Fig. 16 is a schematic view of the mitral valve of fig. 14 at diastole after the valve clasper grasps the leaflets.

Fig. 17 is a schematic view of a partial structure of a valve clamping system according to an embodiment of the present invention.

Fig. 18 is a schematic cross-sectional view of fig. 17.

Fig. 19 is a schematic view of a valve clip according to another embodiment of the present invention in an open state.

FIG. 20 is a schematic view of the valve binder of FIG. 19 in an uncoated state.

FIG. 21 is a schematic view of the distal clip of the valve clip of FIG. 19 inverted.

Fig. 22 is a schematic view of a valve clip according to yet another embodiment of the present invention in an open position.

Detailed Description

The technical solutions in the embodiments of the present invention will be described clearly and completely with reference to the accompanying drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments in the present invention, all other embodiments obtained by a person skilled in the art without any creative effort belong to the protection scope of the present invention.

In the description of the present invention, it should be noted that the terms "upper", "lower", "left", "right", "inner", "outer", and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of description and simplification of description, but do not indicate or imply that the device or element referred to must have a specific orientation, be constructed in a specific orientation, and be operated, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," "third," and the like are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.

In the description of the present invention, it is to be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and the like are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected; may be directly connected or indirectly connected through an intermediate. The specific meaning of the above terms in the present invention can be understood in specific cases to those skilled in the art.

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, the distal end refers to the end farther from the operator, and the axial direction refers to the direction parallel to the connection line between the center of the distal end and the center of the proximal end of the medical device; the foregoing definitions are for convenience only and are not to be construed as limiting the present invention.

Referring to fig. 3 to 5, the present invention provides a valve clamping device 100, which includes a push rod 10 extending along an axial direction, a proximal clip 21, a distal clip 23, and a covering film 30. The proximal clamping piece 21 and the distal clamping piece 23 are radially expanded relative to the push rod 10, the distal end of the distal clamping piece 23 is connected to the push rod 10, the proximal clamping piece 21 is arranged between the push rod 10 and the distal clamping piece 23, a valve accommodating space 25 is formed between the proximal clamping piece 21 and the distal clamping piece 23, the push rod 10 can drive the distal clamping piece 23 to radially expand, and the proximal clamping piece 21 is close to the distal clamping piece 23 due to the elasticity of the proximal clamping piece 21 so as to clamp valve tissue in the valve accommodating space 25. The cover film 30 includes a first cover film 31 covering at least a side of the proximal clip 21 facing the valve receiving space 25 and/or a second cover film 32 covering at least a side of the distal clip 23 facing the valve receiving space 25.

Wherein a set of proximal clips 21 and distal clips 23 respectively form a clip 20.

In order to ensure the safety after implantation, the proximal clip 21 and the distal clip 23 are made of biocompatible metal material, and the metal material is selected from common implantation metal materials such as stainless steel, cobalt alloy, cobalt-chromium alloy, titanium alloy or nickel-titanium alloy. Wherein, the proximal clip 21 is made of elastic material with shape memory function, and the distal clip 23 is made of rigid material, so as to ensure that the two cooperate to clamp and fix the valve tissue. In this embodiment, the proximal clip 21 is made of a super-elastic nickel-titanium alloy, and the distal clip 23 is made of a stainless steel or cobalt-chromium alloy having a high hardness.

Preferably, the first coating 31 extends to the edge wrapping the proximal clip 21, the second coating 32 extends to the edge wrapping the distal clip 23, the coverage rate of the first coating 31 on the proximal clip 21 ranges from 50% to 90%, and the coverage rate of the second coating 32 on the distal clip 23 ranges from 40% to 80%, so as to avoid the edges of the proximal clip 21 and the distal clip 23 from damaging the valve tissue.

In the present invention, by providing the first covering film 31 and/or the second covering film 32 on at least part of the surface of the proximal clip 21 and/or the distal clip 23 of the clip 20, at least part of the metal surface and/or sharp metal edge of the proximal clip 21 and/or the distal clip 23 can be wrapped to prevent at least part of the metal surface and/or sharp metal edge of the clip 20 from directly contacting the valve tissue held in the valve holding space 25, thereby reducing or avoiding tissue allergy and inflammatory reaction, and damaging the held valve tissue.

Specifically, referring to fig. 6 to 8, the push rod 10 is a rod-shaped or tubular body. In this embodiment, the push rod 10 is a round rod, a ring groove 11 is circumferentially formed at a proximal end of an outer peripheral surface of the push rod 10, and an internal threaded hole 13 is axially formed in a proximal end surface of the push rod 10. The distal end of the push rod 10 is provided with a connecting seat 15, and the connecting seat 15 includes two opposite first planes and a side surface connecting the two first planes. Two opposite first planes are provided with through pin holes. The side surface comprises a curved surface positioned at the far end and a second plane positioned at the near end and connected with the curved surface, the far 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 section area of the push rod 10. The section size of the connecting seat 15 parallel to the second plane direction is gradually reduced from the proximal end to the distal end, that is, the connecting seat 15 may be shaped as a hemisphere, a spherical crown, a bullet, or the like, so that the valve clip 100 is more easily pushed in vivo.

Wherein, the outer surfaces of the push rod 10 and the connecting seat 15 are smooth to avoid damaging valve leaflets or hooking chordae tendineae.

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.

Further, referring to fig. 6, fig. 7 and fig. 9, the valve clamping device 100 further includes a fixing base 40, and the fixing base 40 includes a first seat 41 and a second seat 42 connected to a distal end of the first seat 41. The first fastening structure 41 and the second fastening structure 42 may be an integral structure or a non-integral structure. In this embodiment, the first seat 41 and the second seat 42 are an integral structure.

In this embodiment, the first seat 41 is a circular tube with two open ends, and the push rod 10 is disposed in the cavity of the first seat 41. The outer wall of first pedestal 41 that is close to the distal end sets up trompil 411, sets up shell fragment 413 in the trompil 411, and shell fragment 413 includes the link and the free end relative with the link, and the link is connected in the near-end edge of trompil 411, and the free end extends to the inner chamber of pipe body. That is, in a natural state, the free end of the elastic piece 413 is inclined toward the inner cavity of the first housing 41 relative to the connection end. The proximal end of the first seat 41 is provided with a connecting portion 415, and the connecting portion 415 is used for connecting with a pushing device for pushing the valve clip 100 to the heart valve. In this embodiment, the connecting portion 415 is at least one pair of T-shaped grooves opened on the outer wall of the first seat 41, and preferably, the at least one pair of T-shaped grooves are disposed symmetrically with respect to the axial line of the first seat 41, and each T-shaped groove includes a first groove section and a second groove section perpendicularly crossing the first groove section. The second slot segment is located at the far end of the first slot segment, the extending direction of the first slot segment is the same as the axial direction of the first seat body 41, and the near end of the first slot segment penetrates through the near end face of the first seat body 41.

In this embodiment, second fastening structure 42 includes two clamping plates 421 spaced apart from each other, and two clamping plates 421 are connected by two connecting rods 423. The two connecting rods 423 are arranged at intervals, the two connecting rods 423 and the two clamping plates 421 enclose a penetrating channel 425, the penetrating channel 425 corresponds to the tube cavity of the first seat body 41, and the push rod 10 can be inserted into the tube cavity of the penetrating channel 425 and the tube cavity of the first seat body 41 and can move axially. Further, two opposite ends of the two splints 421 are provided with fixing holes 427.

The through passage 425 may be a square passage or a circular passage. In this embodiment, the through passage 425 is a square passage.

It should be understood that only one embodiment of the fixing base 40 is shown here, and actually, the fixing base 40 may have other structures, which are not described herein.

Referring to fig. 5 and 10, the proximal clip 21 includes a connecting end 211 and a free end 212, which are opposite to each other, and the connecting end 211 is fixed on the fixing base 40. In this embodiment, the connecting ends 211 of the two proximal clips 21 are connected into a whole by the connecting piece 213, the connecting piece 213 is provided with a through hole, the middle portion of the connecting piece 213 is fixedly connected to the connecting portion of the first seat 41 and the second seat 42, so as to fix the connecting ends 211 of the two proximal clips 21 to the fixing base 40, and the through hole of the connecting piece 213 corresponds to the inner cavity of the first seat 41. Obviously, in other embodiments, the connecting end 211 of the proximal clip 21 can be directly fixed at the connection position of the first fastening structure 41 and the second fastening structure 42.

Wherein the proximal jaw 21 is at least partially made of an elastic material having a shape memory function. After heat setting, the proximal clip 21 is in a U-shape in a natural state, i.e. the proximal clip 21 is disposed at an angle to the push rod 10 so as to cooperate with the distal clip 23 to clamp the valve tissue. The angle between the extending directions of the two sides of the proximal clip 21 ranges from 0 to 200 degrees. In this embodiment, the proximal clip 21 is cut from nitinol and then placed in a sizing mold, the sizing mold is placed in an electrically heated circulating air box furnace, a sizing heat treatment is performed at 300-650 ℃, the clip is taken out and rapidly placed in purified water for cooling, and the sizing mold is removed to obtain the sized proximal clip 21. Specifically, in this embodiment, the proximal clip 21 is made of nitinol, so as to provide the proximal clip 21 with elastic force to drive the proximal clip 21 toward the distal clip 23 for clipping the valve tissue. In other embodiments, the connecting ends 211 of the proximal jaws 21 are made of an elastic material, and the free ends 212 of the proximal jaws 21 are made of an inelastic material such as aluminum alloy, and the elastic force of the connecting ends 211 drives the proximal jaws 21 toward the distal jaws 23.

It should be noted that the free ends 212 of the proximal clips 21 extending radially outward and proximally relative to the push rod 10 can be controlled by the adjustment wires, such that the free ends 212 of the proximal clips 21 are tensioned and attached to the surface of the fixed base 40 by the adjustment wires to be close to the push rod 10 in the delivery state, and after the control of the free ends 212 by the adjustment wires is released, the connecting ends 211 of the proximal clips 21 spring back due to their elastic memory property, and the proximal clips 21 return to their natural state and press the valve toward the distal clips 23. Preferably, the included angle between the extending directions of the two sides of the proximal clip 21 in the natural unfolding state should be slightly larger than the included angle between the two distal clip pieces 23, so as to provide a more stable clamping force, that is, the included angle between the extending direction of each side of the proximal clip piece 21 and the push rod 10 is larger than or equal to the included angle between the distal clip piece 23 and the push rod 10 when the distal clip piece 23 corresponding to the side is unfolded to the maximum state, so as to ensure that a certain clamping force exists between the distal clip piece 23 and the proximal clip piece 21, so as to clamp the valve tissue between the distal clip piece 23 and the proximal clip piece 21.

Further, the proximal clip 21 further includes a first surface 214 facing the distal clip 23 and the valve accommodating space 25 and a second surface 215 facing away from the first surface 214, and the first surface 214 is provided with a clamping enhancing member 216 to increase the friction force between the proximal clip 21 and the valve tissue clamped in the valve accommodating space 25, thereby improving the clamping force of the valve clamp 100 on the valve tissue. Specifically, in this embodiment, the gripping enhancement 216 is provided as two spaced rows of barbs disposed on opposite sides of the first surface 214. The barbs may be integrally formed on proximal clip 21 or may be formed of the same or different material as proximal clip 21 and attached to first surface 214 of proximal clip 21, for example, a nitinol wire or rod may be secured to first surface 214 by a sleeve. The root of the barb is connected to the proximal clip 21, the end of the barb opposite to the root is a free end, which faces the distal clip 23 in a naturally expanded state. The included angle between the extending direction of the barbs and the first surface 214 is less than or equal to 90 degrees to enhance the gripping force of the valve binder 100 on valve tissue. Furthermore, the hanging end of each barb is a smooth arc-shaped surface, so that valve tissues are prevented from being damaged.

In other embodiments, the number of barbs may be 1, 2, or other reasonable number.

In other embodiments, the clamping enhancement 216 can be protrusions, bumps, or other irregularly distributed protrusions protruding from the first surface 214, or can be a rough surface at least partially covering the first surface 214 to enhance the clamping force on the valve tissue.

The proximal clamping piece 21 is provided with a plurality of openings to reduce the weight of the proximal clamping piece 21, prevent the overweight clamp 10 from slipping or damaging the valve leaflets caused by falling below the valve leaflets for a long time, and simultaneously facilitate the climbing and growth of endothelial cells.

Referring to fig. 5 to 7, the valve clamping device 100 includes two distal clips 23 disposed axially symmetrically with respect to the push rod 10, each distal clip 23 includes a connecting section 231 disposed at a distal end and a clamping section 232 disposed at a proximal end of the connecting section 231, the proximal end of the connecting section 231 is rotatably connected to the second seat 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 42 of the fixed base 40 by a first pin 51, two distal clips 23 are located at two opposite ends of the first seat 42, and the distal ends of the two distal clips 23 intersect and are movably connected to the connecting seat 15 of the push rod 10 by a same second pin 52.

In other embodiments, the first pin 51 and/or the second pin 52 may be replaced with a bolt.

In this embodiment, the connecting section 231 of each distal clip 23 includes two connecting pieces opposite to each other at an interval, a connecting hole is formed at a proximal end of each connecting piece, a sliding slot is formed at a distal end of each connecting piece, and the sliding slot extends from the distal end of each connecting piece to the proximal end. Obviously, in other embodiments, the connection segment 231 may include only one connection piece.

Specifically, one end of the first pin 51 passes through the connecting hole on the connecting piece on one side of the distal clip 23, then passes through the corresponding fixing hole 427 of the second seat 42, and finally is inserted into the connecting hole on the connecting piece on the other side opposite to the distal clip 23, and a first blocking piece is welded at the end of the first pin 51 to prevent the first pin 51 from slipping off, so as to rotatably connect the proximal end of the connecting section 231 of the distal clip 23 to the second seat 42 of the fixing base 40. The connecting sections 231 of the two distal end clips 23 located on the same side of the second seat 42 are stacked one another, the sliding grooves of the two connecting sections 231 are communicated, one end of the second pin 52 sequentially penetrates through the sliding grooves of the two connecting pieces of the two distal end clips 23 located on the same side of the connecting seat 15, and then penetrates through the pin hole of the connecting seat 15, and finally is inserted into the sliding grooves of the two connecting pieces of the two distal end clips 23 located on the opposite side of the connecting seat 15, and a second stopper is welded at the end of the second pin 52 to prevent the second pin 52 from slipping, so that the distal ends of the connecting sections 231 of the two distal end clips 23 are movably connected to the connecting seat 15 of the push rod 10 through the same second pin 52.

When the push rod 10 axially moves in the lumen of the through channel 425 and the first seat 41, the second pin 52 inserted in the pin hole of the connecting seat 15 can slide in the sliding slot on the connecting piece of the distal clip 23, and further drives the distal clip 23 to rotate around the first pin 51 with the connecting position where the proximal end of the connecting section 231 is connected to the second seat 42 as the rotation center, and the clamping section 232 of the distal clip 23 opens and closes relative to the fixed base 40 and the push rod 10, and when the proximal clip 21 is released and freely expands due to its own elastic memory function, it can approach the distal clip 23 to clamp the valve tissue.

Further, the distal clamping piece 23 further comprises a third surface 233 facing the proximal clamping piece 21 and the valve receiving space 25 and a fourth surface 234 facing away from the third surface 233, the third surface 233 being opposite to the first surface 214 of the proximal clamping piece 21.

The third surface 233 may 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 faces the proximal clip piece 21. By providing the third surface 233 with a curved surface, the contact area and the clamping area of the distal clamping piece 23 with the valve tissue can be increased, thereby providing a stable clamping force. Moreover, the curved third surface 233 forms a receiving slot, and when the proximal clip piece 21 is closed towards the distal clip piece 23, the barb on the first surface 214 of the proximal clip piece 21 can be received in the receiving slot to press the valve leaflet located in the leaflet receiving space 25, or to reduce the volume of the valve binder 100 when it is closed, so that the valve binder 100 can be more easily transported in vivo.

The third surface 233 may be provided with a clamping enhancement structure, which may be a protrusion, a groove, or a pad made of a biocompatible material with a high friction coefficient and attached to the third surface 233. By providing protrusions, grooves or pads 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.

Referring to fig. 3 and 6, in order to prevent the metal surface and/or sharp edge of the valve clamping device 100 from damaging the clamped valve tissue, the valve clamping device 100 is covered with a covering film 30. Specifically, in the present embodiment, the covering membrane 30 includes a first covering membrane 31 covering the proximal jaw 21 and a second covering membrane 32 covering the distal jaw 23.

Wherein the first coating 31 completely covers at least the first surface 214 of the proximal clip 21 and the second coating 32 completely covers at least the third surface 233 of the distal clip 23. Preferably, in the present 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.

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 reduce the cost.

The first coating 31 and the second coating 32 are made of at least one layer of biocompatible polymer material with biocompatibility, oxidation resistance and dissolution resistance, and the polymer material is at least one selected from PET, polyester, PTFE, silicone, silica gel and urethane. Further, the materials of the first and

second cover films

31 and 32 may be the same or different. In the present embodiment, the first coating film 31 and the second coating film 32 are each preferably a single-layer PET coating film.

The first coating 31 and the second coating 32 are fixed by any means such as sewing, dip coating, bonding, fusing, or binding. In this embodiment, the first film 31 is adhesively secured to the proximal clip 21 and the second film 32 is stitched to the distal clip 23.

In this embodiment, both sides of the valve clamping device 100 facing the valve accommodating space 25 and the edges thereof are completely covered by the covering film 30, and the valve tissue clamped in the valve accommodating space 25 does not directly contact with the metal part of the clamp 20, so that tissue allergy, inflammatory reaction, clamping injury or scratching of the valve tissue in the valve accommodating space 25 can be avoided.

In other embodiments, the valve clip 100 may cover only the first covering film 31 or the second covering film 32, that is, one side of the valve clip 100 facing the valve accommodating space 25 and the edge thereof are completely covered by the covering film 30, and specifically, the side of the proximal clip 21 facing the valve accommodating space 25 covers the first covering film 31 or the side of the distal clip 23 facing the valve accommodating space 25 covers the second covering film 32, which may also reduce damage to the valve tissue.

As shown in fig. 3 and 4, in the present embodiment, the second covering film 32 covering the two distal clips 23 covers the outer surfaces of the connecting portions (i.e., the portions where the second seat 42 and the connecting seat 15 of the push rod 10 are located) of the two distal clips 23, so as to cover the sharp metal edges of the connecting portions, so as to prevent the sharp metal edges of the connecting portions from damaging the valve tissue or the inner wall of the blood vessel during the process of pushing the valve clip 100.

Of course, in other embodiments, the connecting portion may not cover the second cover film 32.

Further, the coating film 30 is provided with a functional drug by a treatment method such as biological modification, dipping, brushing, dripping, or spraying. For example, an anticoagulant such as heparin may be applied to the surface of the first coating film 31 by dipping, spraying, or the like, or the surface of the first coating film 31 may be biologically modified to have antithrombin properties, and a drug coating may be further applied to the first coating film 31, wherein the drug coating contains at least one of an anticoagulant drug, an antiplatelet drug, or an anti-tissue proliferation drug, so as to promote endothelialization, avoid tissue hyperproliferation, reduce the incidence of corresponding complications, and improve the post-operative survival rate. Similarly, the second film 32 can be provided with a corresponding functional drug, which is not described herein.

Referring to fig. 11, after the proximal clip 21 covers the first membrane 31, the free end of the barb 216 will pierce through and extend out of the first membrane 31 to clamp the valve tissue. Preferably, the thickness of the first cover film 31 covering the area near the barb 216 is larger than the thickness of the first cover film 31 covering the other area of the proximal clip 21, so as to avoid valve tissue damage caused by the fact that the free end of the barb 216 penetrates too deeply into the valve tissue due to too long length of the first cover film 31.

The length of the free end of the barb penetrating through the first coating film 31 is 0.2mm to 2mm, preferably 0.5mm to 1 mm.

It can be understood that when the proximal clip 21 does not cover the first cover film 31, the sharp metal edges are exposed due to the processing, and more exposed sharp edges are likely to damage the valve tissue. Referring to fig. 12 and 13, in the present invention, after the proximal clamping piece 21 covers the first covering film 31, most sharp metal edges are covered in the first covering film 31, and only the hanging end of the barbs is exposed, so that the clamping force on the valve tissue can be ensured and the valve tissue can not be seriously damaged. Moreover, when barb 216 centre gripping valve tissue, first tectorial membrane 31 is whole to have certain hindrance control action to piercing of barb 216, can effective control barb 216 pierce the degree of depth of valve tissue, reduces because the uneven excessive damage that brings for the valve of atress. In addition, in some extreme conditions, once the valve is punctured by the barbs 216, the first cover film 31 immediately covers the punctured position, the high molecular material of the first cover film 31 has high biocompatibility, and the effect of the functional drug on the first cover film 31 can promote the tissue growth near the punctured position, so that the punctured hole is quickly blocked, blood is prevented from permeating into the pericardial cavity, and the risk of pericardial effusion and even cardiac arrest is reduced.

Similarly, after the second covering film 32 is added to the distal clip 23, most of the metal surface is covered in the second covering film 32, so as to avoid serious damage to the valve tissue caused by the distal clip 23.

In addition, the first covering film 31 and the second covering film 32 can also play a role in buffering, so that the clamped valve tissue is stressed uniformly, and the damage caused by the overlarge local stress of the valve tissue is avoided.

As previously mentioned, in this embodiment, the valve binder 100 can be used to reduce or treat "mitral regurgitation". Specifically, referring to fig. 14 to 16 together, the valve clamping device 100 is placed at a position where the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve are not normally involuted, such that one side of one of the distal clamping piece 23 and the proximal clamping piece 21 clamps an edge of the anterior leaflet 1a of the mitral valve, and one side of the other of the distal clamping piece 23 and the proximal clamping piece 21 clamps an 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 are not normally involuted together, and the covering film 30 on the valve clamping device 100 can prevent the mitral valve from being damaged or scratched. As shown in fig. 15, when the heart contracts, the anterior leaflet 1a and the posterior leaflet 1b are folded, and the anterior leaflet 1a and the posterior leaflet 1b are partially or completely folded at the position where they cannot be normally combined, the area a of the mitral valve opening is reduced or the mitral valve can be completely closed, and only a small amount of blood flows back into the left atrium from the mitral valve opening, so that the "mitral regurgitation" can be reduced or treated. As shown in fig. 16, when the heart is relaxed, the anterior leaflet 1a and the posterior leaflet 1B are only paired together at the position B where the valve clamping device 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.

In fig. 15 and 16, the direction of the arrow is the direction of blood flow.

The cover 30 may or may not allow blood to permeate therethrough. Preferably, in the present embodiment, the first and

second membranes

31 and 32 can allow blood to permeate therethrough, so as to increase the blocking force for blood circulation, thereby reducing the blood pressure difference between the left atrium and the left ventricle.

Specifically, referring to fig. 3 and 4, the covering film 30 may have one or more of a two-dimensional sieve structure, a porous film body, a microporous structure, a woven or non-woven mesh structure, and a foam structure, so as to allow blood to permeate and flow through the covering film 30. In this embodiment, the first film 31 and the second film 32 are both woven mesh structures, and both are provided with a plurality of meshes.

The first coating 31 has an aperture ratio smaller than that of the second coating 32.

The open porosity is a percentage of an open pore area in the entire area of the coating film.

The second coating 32 has a larger opening ratio, so that the second coating 32 has better elasticity and elongation than the first coating 31, when the distal end clamping piece 23 covered with the second coating 32 is opened relative to the push rod 10, the second coating 32 can generate corresponding elastic deformation along with the opening and closing of the distal end clamping piece 23, and the second coating 32 is attached to the distal end clamping piece 23 all the time.

Wherein the number of meshes per inch of the first coating 31 is in the range of 250 meshes to 2500 meshes, and the number of meshes per inch of the second coating 32 is in the range of 24 meshes to 250 meshes. In this embodiment, the number of meshes per inch of the first coating 31 is preferably 500 to 2500 meshes, and the number of meshes per inch of the second coating 32 is preferably 50 to 150 meshes.

The meshes of the first and

second coatings

31 and 32 allow blood to pass therethrough and prevent thrombus from passing therethrough. Further, the pore size of the mesh of the first coating 31 is smaller than that of the mesh of the second coating 32. Specifically, the aperture of the mesh of the first coating 31 ranges from 0.01mm to 0.1mm, and the aperture of the mesh of the second coating 32 ranges from 0.2mm to 0.5 mm. In the present embodiment, the aperture of the mesh of the first coating 31 is preferably in the range of 0.01mm to 0.05mm, and the aperture of the mesh of the second coating 32 is preferably in the range of 0.2mm to 0.5 mm.

Preferably, in some embodiments, the pore size of the mesh disposed in the second film 32 along the proximal to distal direction of the distal clip 23 gradually increases, i.e., the mesh of the second film 32 covering the proximal region (i.e., the clamping section 232) of the distal clip 23 is denser than the mesh of the second film 32 covering the distal region (i.e., the connecting section 231) of the distal clip 23.

Specifically, as shown in fig. 3 and 4, in this embodiment, the aperture of the mesh of the second coating film 32 covering the proximal region (i.e., the clamping section 232) of the distal clip 23 is small, and the second coating film 32 in this region has high compactness, so that the second coating film is not easily worn by the proximal edge of the distal clip 23 and does not affect the opening and closing of the distal clip 23; the aperture of the mesh of the second coating 32 covering the distal region (i.e., the connection section 231) of the distal clip 23 is larger, and the elasticity and the elongation of the second coating 32 in this region are better, so that even under the condition of a larger opening and closing angle, the second coating 32 close to the push rod 10 can deform correspondingly along with the opening and closing of the distal clip 23, thereby ensuring that the second coating 32 is attached and fixed to the distal clip 23.

In the utility model, the first coating film 31 is provided with a plurality of meshes, so that the first coating film 31 can allow blood to permeate through, the normal flow of blood from the left atrium to the left ventricle is not influenced, and the blood is prevented from being retained in the left atrium, thereby reducing the damage of blood pressure to the left atrium cavity; moreover, the number and the aperture of the meshes of the first coating 31 are reasonably set, and the first coating 31 can also form an artificial barrier at the atrium side of the valve leaflet to block thrombus in blood, close the opening of the whole valve clamping device 100 facing the atrium side, and prevent the thrombus from entering the inside of the valve clamping device 100 or the left ventricle, so that the valve clamping device 100 is prevented from falling off or the thrombus enters the left ventricle from the left atrium and then enters the blood circulation of the human body through the aorta; in addition, because the first covering film 31 blocks thrombus from entering between the first covering film 31 and the distal clamping piece 23, the impact force of the thrombus on the distal clamping piece 23 is reduced, the service life of the distal clamping piece 23 is prolonged, and the service life of the valve clamping device 100 is further prolonged. Meanwhile, the first cover film 31 can increase the contact area between the proximal clip 21 and blood to buffer the inflow blood, so as to prevent the proximal clip 21 from deforming and slipping off due to the inflow blood impacting the valve clamp 100.

Similarly, in the present invention, the second covering film 32 with a plurality of meshes can make the blood flow normally circulate in the left atrium and between the left ventricles, thereby reducing the blood pressure difference between the left atrium and the left ventricles; moreover, the second coating 32 can block and retain a very small amount of thrombus entering the interior of the valve clamping device 100 through the first coating 31 in the valve clamping device 100, so as to prevent the thrombus from entering the left ventricle and entering the blood circulation of the human body to induce stroke.

It should be noted that the static friction force refers to the resistance force of two objects contacting each other, which resists relative sliding when the contact surfaces of the two objects tend to slide relative to each other but remain relatively still, and is called static friction forceThe sliding friction force, referred to as static friction force for short, is generally denoted by F. The static friction force can be between 0 and F_MAXIn which F is_MAXIs 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, i.e., f ═ μ N. Mu is a dynamic friction factor which is related to the material of the contact surfaces, the roughness and the elasticity between the contact surfaces. For the valve clamping device 100 implanted on the valve leaflet, the first surface 214 of the proximal clip 21 facing the distal clip 23 is in contact with the upper surface of the valve leaflet, the third surface 233 of the distal clip 23 facing the proximal clip 21 is in contact with the lower surface of the valve leaflet, because the tissue of the valve leaflet is sticky and slippery, the surfaces are full of blood and are in constant high-speed motion, so that there is always a relative sliding tendency 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. In the embodiment, the first covering film 31 with a dense density and a small aperture ratio is covered on the proximal clip 21 with an elastic memory function, and the second covering film 32 with a sparse density and a large aperture ratio is covered on the distal clip 23 made of a rigid material, so that when the valve clamping device 100 is affected by blood flow scouring and leaflet jumping and the positive pressure N is not changed, the dynamic friction factors μ 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 are increased, thereby respectively increasing two friction forces, enabling the two friction forces to be matched to achieve dynamic balance under a stress state, and further increasing the clamping force and the stabilizing force of the valve clamping device 100.

Referring to fig. 17 and 18, the present invention further provides a valve clamping system, which includes a pushing device and the valve clamp 100, wherein the valve clamp 100 can be conveyed 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 comprises an operating handle and a pushing assembly, the proximal end of the pushing assembly is connected with the operating handle, and the distal end of the pushing assembly is detachably connected with the valve clamping device 100. Specifically, the pushing assembly includes a mandrel 210, a liner 220, and an outer tube 230 movably coaxially nested together, the liner 220 being located between the mandrel 210 and the outer tube 230. The operating handle can drive the mandrel 210, the liner 220 and the outer tube 230 to move relatively.

The distal end of the mandrel 210 has external threads 211 that correspond to the internal threads in the internally threaded bore 13 of the proximal end of the push rod 10. When the pushing assembly is connected with the valve clamping device 100, the distal end of the mandrel 210 is in threaded connection with the proximal end of the push rod 10, and the mandrel 210 is driven to move by the operation handle, so that the push rod 10 moves along the axial direction.

The distal end of the outer tube 230 is provided with a T-shaped elastic tab 231 for cooperating with a connecting portion 415 (i.e. a T-shaped slot) on the proximal end of the first housing 41 to connect and unlock the outer tube 230 and the first housing 41. In the natural state, one end of the T-shaped elastic 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 pushing assembly is connected to the valve clamping device 100, the mandrel 210 is in threaded connection with the push rod 10, the operating handle drives the liner tube 220 to move, so that the liner tube 220 extends into the lumen of the first seat 41, the liner tube 220 jacks up the T-shaped elastic piece 231 of the outer tube 230, so that the T-shaped elastic piece 231 is embedded into the T-shaped slot of the first seat 41, and at this time, the first seat 41 is connected to the outer tube 230; when the operating handle is operated to make the liner tube 220 leave the interior of the first housing 41, the T-shaped elastic piece 231 of the outer tube 230 restores to the natural state, i.e. deforms inward and is separated from the T-shaped slot at the proximal end of the first housing 41, so that the first housing 41 and the outer tube 230 are unlocked.

The pushing device also includes controls, i.e., the aforementioned adjustment lines, for constraining the free ends 212 of the proximal clips 21 to the surface of the stationary base 40 proximate to the push rod 10. Wherein, the adjusting line can be made of metal or polymer materials such as PTFE.

The following description of the operation method of the valve clamping system of the present invention is given by taking the mitral valve repair process as an example, and mainly includes the following steps:

the first step is as follows: the free ends 212 of the proximal clips 21 are tied to the surface of the fixed base 40 using adjustment wires and the pusher assembly is then attached to the valve clip 100. Specifically, the mandrel 210 of the pushing assembly is rotated such that the mandrel 210 is fixed with the push rod 10. And the liner tube 220 is axially moved towards the distal end, so as to jack up the T-shaped elastic piece 231 of the outer tube 230, so that the T-shaped elastic piece 231 is embedded into the T-shaped groove of the first seat body 41, and the first seat body 41 and the outer tube 230 are in a connected state. At this time, the free end of the elastic piece 413 on the first seat 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 close to the surface of the push rod 10 and remain unchanged.

The second step is that: the valve clip 100 attached thereto is advanced from the left atrium, through the mitral valve, to the left ventricle via the pusher assembly, using a trans-atrial septal approach.

The third step: the relative position of the valve clip 100 and the mitral valve is adjusted by the pushing assembly so that the valve clip 100 approaches the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve.

The fourth step: further, the liner tube 220 is axially moved to the distal end, so that the liner tube 220 pushes up the free end of the elastic piece 413 of the first seat 41, and the free end of the elastic 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.

The fifth step: the mandrel 210 is moved in the proximal direction by operating the handle, so that the push rod 10 connected to the mandrel 210 is moved in the proximal direction, and the distal clip 23 is driven to open relative to the push rod 10.

And a sixth step: the valve clip 100 is oriented so that the distal clip 23 is perpendicular to the line of apposition of the mitral valves.

The seventh step: proximally withdrawing the entire valve binder 100 so that the distal clip 23 holds the leaflets against the left ventricle side; releasing the binding of the adjustment wire to proximal clip 21, proximal clip 21 springs back to expand relative to pushrod 10 such that the leaflets are clamped between proximal clip 21 and distal clip 23, i.e., anterior leaflet 1a and posterior leaflet 1b of the mitral valve are clamped between a set of proximal clip 21 and distal clip 23, respectively.

Eighth step: moving the mandrel 210 in a distal direction, the mandrel 210 causes the push rod 10 to move axially in a distal direction, thereby driving the distal jaws 23 to close relative to the push rod 10 until fully closed.

The ninth step: the outer tube 230 is fixed, the liner tube 220 is retracted to a certain stroke, and the free end of the spring piece 413 of the first seat 41 is snapped 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 closed. The rotation of the spindle 210 is controlled by operating the handle, so that the thread between the spindle 210 and the push rod 10 is unlocked. Liner 220 and mandrel 210 are withdrawn proximally until T-shaped tabs 231 of outer tube 230 are unlocked from the T-shaped slots of first housing 41. At this point, the valve clip 100 is completely separated from the pusher assembly. The pushing assembly is withdrawn from the patient, and the valve binder 100 is left in the patient to complete the leaflet edge-to-edge repair of the mitral valve. As shown in fig. 14, the proximal clip of the valve binder 100 is fixed to the atrium side of the valve leaflet, and the first covering film 31 contacts with the atrium side of the valve leaflet, so as to isolate the direct contact between the proximal clip 21 and the valve leaflet, increase the friction force of the metal proximal clip 21 to the valve leaflet, make the stress more uniform, and make the stress of each barb uniform, thereby avoiding the damage of the valve leaflet caused by too deep penetration, uneven stress and too large stress; meanwhile, the second coating 32 can improve the adherence of the distal clip 23 to the valve and increase the contact area of the distal clip 23 and the valve; the surface of the far-end clamping piece 23 plays a role in buffering, metal is prevented from being directly contacted with the valve, and the action of mechanical force on the valve is relieved, so that inflammatory reaction is avoided.

It is to be understood that the valve clamping system of the present invention may also be used to deliver a valve clamp to a mitral valve via a transapical approach or the like.

The utility model discloses a valve clamping system can realize operating in vitro to with valve clamping device 100 clamping valve leaf, alleviate or avoid the problem of "mitral valve regurgitation", the tectorial membrane 30 of valve clamping device 100 can reduce or avoid the damage by the valve tissue of centre gripping in addition, also can avoid damaging valve tissue or other vascular tissues at the propelling movement in-process.

Referring to fig. 19 and 20, a valve clamping device 100a according to another embodiment of the present invention is shown, which includes a push rod 10a, a distal clip 23a axially symmetrically disposed 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 cooperating with the distal clip 23a to clamp and fix a valve leaflet, a first covering film 31a covering the proximal clip 21a, and a second covering film 32a covering the distal clip 23 a. When the distal clip 23a is closed with the pushrod 10a, it can be delivered through the sheath to the vicinity of the patient's valve. The structures of the proximal clip piece 21a and the first membrane 31a are the same as the structures of the proximal clip piece 21 and the first membrane 31 of the valve clamping device 100 in the first embodiment, and are not described again.

The connecting seat 15a is located at the far end of the push rod 10a, and a round hole is formed at the near end of the connecting seat 15a and used for connecting the push rod 10a in a threaded manner, a welding manner and the like. The connecting base 15a is provided at both sides thereof with pin holes, and a pair of connecting rods 16a are hinge-connected by a pin, i.e., each connecting rod 16a is relatively rotated with the connecting base 15a through a hinge connection. The other end of link 16a is pinned to distal jaw 23 a. The fixing base 40a is sleeved outside the push rod 10a, and the push rod 10a can move along the axial direction thereof, so that the connecting seat 15a and the fixing base 40a can move, and the far-end clamping piece 23a is driven to open and close relative to the push rod 10 a. Referring to fig. 21, in this way, a wider range of opening angles can be achieved, the angle between the two distal clips 23a can be up to 320 degrees at most, preferably the opening angle is from 0 degree to 270 degrees, and more preferably 120 degrees to 180 degrees, that is, after the distal clips 23a are opened relative to the push rod 10a, the distal clips can be turned over downward to some extent, due to the elastic retraction function of the second cover film 32a, the second cover film 32a can conform to the deformation and open without significant resistance when the distal clips 23a are opened, so that the valve leaflets which are constantly in motion can be conveniently clamped, and the clamping success rate is improved.

Fig. 22 shows a valve clip 100b according to another embodiment of the present invention, which differs from the embodiment shown in fig. 3 in that: the valve clamping device 100b comprises a V-shaped proximal clip 21b and a distal clip 23b, and the proximal clip 21b and the distal clip 23b move relatively and overlap to clamp two valve leaflets under the driving of the push rod 10 b.

Wherein, a side surface of the proximal clip piece 21b facing the distal clip piece 23b and a side surface of the distal clip piece 23b facing the proximal clip piece 21b are at least partially covered with the covering film 30 b.

Specifically, each of the proximal clip pieces 21b is covered with a first covering film 31b, each of the distal clip pieces 23b is covered with a second covering film 32b, and a connecting portion between the two distal clip pieces 23b is covered with the second covering film 32 b.

It is understood that the connecting portion between the two proximal jaws 21b may also cover the first covering film 31 b.

The first coating 31b and the second coating 32b are respectively identical to the first coating 31 and the second coating 32 in structure and function, and are not described herein again.

It is understood that the

valve clamping devices

100a and 100b and the pushing device can also form a valve clamping system, and the usage steps are the same as those described above, and are not described herein again.

It should be noted that the above description is made by taking the valve clip 100 as an example for reducing or treating "mitral regurgitation". It is understood that, in other embodiments, the valve clamping device 100 may also be used to alleviate or treat "tricuspid regurgitation", and the principle and structure thereof are substantially the same as those of the valve clamping device 100 for solving "mitral regurgitation" in the embodiment of the present invention, and only a plurality of clamps are required to be formed by a plurality of sets of proximal clamping pieces and distal clamping pieces, and each clamp clamps one leaflet respectively, which is not described herein again.

Obviously, in other embodiments, the valve clamping device 100 provided by the present invention can also be applied to other minimally invasive surgical operations requiring more than three pieces of valve tissue to be clamped together.

The above is an implementation manner of the embodiments of the present invention, and it should be noted that, for those skilled in the art, a plurality of improvements and decorations can be made without departing from the principles of the embodiments of the present invention, and these improvements and decorations are also considered as the protection scope of the present invention.

Claims

1. A valve clip with a cover, comprising:

a push rod;

the far-end clamping piece is connected to the push rod, the near-end clamping piece is arranged between the push rod and the far-end clamping piece, a valve accommodating space is formed between the near-end clamping piece and the far-end clamping piece, the push rod can drive the far-end clamping piece to be spread in a radiation mode, and the near-end clamping piece is spread by means of elasticity of the near-end clamping piece and then is close to the far-end clamping piece to clamp valve tissues in the valve accommodating space; and

a covering membrane including a first covering membrane covering the proximal clip at least facing one side of the valve receiving space and/or a second covering membrane covering the distal clip at least facing one side of the valve receiving space.

2. The valve binder of claim 1, wherein the proximal clip is made of an elastic material having a shape memory function and the distal clip is made of a rigid material.

3. The valve clip of claim 1, wherein the first cover has a coverage of the proximal clip in a range of 50% to 90% and the second cover has a coverage of the distal clip in a range of 40% to 80%.

4. The valve clip of claim 1, wherein the first cover membrane extends to wrap around an edge of the proximal clip; the second cover film extends to an edge that wraps the distal clip.

5. The valve binder of claim 1, wherein the proximal clip comprises a first surface facing the distal clip, the first cover film at least completely covering the first surface.

6. The valve clip of claim 5, wherein the proximal clip further comprises a second surface facing away from the first surface, the first cover extending over at least a portion of the second surface.

7. The valve binder of claim 5, wherein the first surface has at least one barb disposed thereon, the free end of the at least one barb facing the distal clip, the at least one barb extending through the first cover.

8. The valve binder of claim 7, wherein the length of the free end of the barb that passes out of the first cover ranges from 0.2mm to 2 mm.

9. The valve binder of claim 7, wherein the thickness of the first cover film covering the area near the barbs is greater than the thickness of the first cover film covering the other area of the proximal clip.

10. The valve binder of claim 1, wherein the distal clip comprises a third surface facing the proximal clip, the second cover film at least completely covering the third surface.

11. The valve clip of claim 10, wherein the distal clip further comprises a fourth surface facing away from the third surface, the second cover film extending over at least a portion of the fourth surface.

12. The valve binder of claim 1, wherein the covering membrane is one or more of a two-dimensional sieve structure, a porous membrane body, a microporous structure, a woven or non-woven mesh structure, and a foamed structure.

13. The valve binder of claim 12, wherein the first and second cover membranes each have a mesh-like structure, and wherein the first cover membrane has a smaller open area than the second cover membrane.

14. The valve binder of claim 13, wherein the first cover membrane has a number of mesh openings per inch of length ranging from 250 mesh to 2500 mesh, and the second cover membrane has a number of mesh openings per inch of length ranging from 24 mesh to 250 mesh.

15. The valve clip of claim 13, wherein the pores of the mesh of the first cover are smaller than the pores of the mesh of the second cover; the aperture range of the meshes of the first covering film is 0.01mm to 0.1mm, and the aperture range of the meshes of the second covering film is 0.2mm to 0.5 mm.

16. The valve clip of claim 15, wherein the second cover has a mesh opening that increases in size in a direction from the proximal end to the distal end of the distal clip.

17. The valve clip of claim 1, wherein the cover is made of at least one layer of a biocompatible polymeric material selected from at least one of PET, polyester, silicone, PTFE, silicone, or urethane.

18. The valve clip of claim 17 wherein the first and second cover films are of the same or different materials.

19. The valve clip of claim 1, wherein the covering membrane is provided with a functional drug by a process of biological modification, dipping, brushing, dripping or spraying.

20. The valve binder of claim 1, wherein the cover is secured by sewing, dip coating, bonding, fusing, or taping.

21. A valve clamping system comprising a pusher and a valve clamp of any one of claims 1 to 20, the pusher comprising an operating handle and a pusher assembly, the pusher assembly having a proximal end connected to the operating handle and a distal end detachably connectable to the valve clamp.

22. The valve clamping system of claim 21, wherein the push assembly comprises a mandrel, a liner, and an outer tube movably coaxially nested together, the liner being positioned between the mandrel and the outer tube.

23. The valve clamping system of claim 21, wherein the pushing device further comprises a control member for securing the proximal clip against the push rod.