CN112741709A

CN112741709A - Adjustable valve clamping system

Info

Publication number: CN112741709A
Application number: CN201911050473.1A
Authority: CN
Inventors: 张庭超; 王泽涛; 张伟伟; 郑贤章
Original assignee: Hangzhou Valgen Medtech Co Ltd
Current assignee: Hangzhou Valgen Medtech Co Ltd
Priority date: 2019-10-30
Filing date: 2019-10-30
Publication date: 2021-05-04

Abstract

The invention provides an adjustable valve clamping system. The adjustable valve clamping system comprises a pushing device and a valve clamp. The valve clamp comprises a clamp main body and a clamp adjusting mechanism. The clamping device main part comprises a fixing seat, a near-end clamping piece and a far-end clamping piece, the fixing seat is used for being connected with a pushing device to push the clamping device main part through the pushing device, and the near-end clamping piece is matched with the far-end clamping piece to clamp valve tissues. The clamping device adjusting mechanism is located between the pushing device and the fixing seat and comprises an adjusting piece which can slide to the fixing seat in the axial direction in a sleeved mode, and when the clamping device main body is folded, the adjusting piece abuts against the near-end clamping piece to adjust the drawing degree of the clamping device main body to the valve tissue. The adjustable valve clamping system provided by the invention can ensure that the clamp body has enough clamping force to avoid slipping, and can adjust the traction degree of the clamp body to valve tissues through the clamp adjusting mechanism.

Description

Adjustable valve clamping system

Technical Field

The invention relates to the field of medical equipment, in particular to an adjustable valve clamping system.

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 3 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 or related structures of the mitral valve 1 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 backflow of blood 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 operation is based on the edge-to-edge operation principle of a valve, a valve clamp is conveyed to a mitral valve through an interventional catheter, 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 together, and the purposes of reducing the gap between the leaflets and reducing the regurgitation of the mitral valve are achieved. However, due to differences in the physiology of the mitral valve between patients, and the severity of mitral regurgitation, the spacing of the anterior and posterior leaflets of the mitral valve varies widely between patients. For patients with a large spacing between the anterior and posterior leaflets of the mitral valve, if forced coapting with a valve clamp having longer clamp arms in order to reduce the difficulty of clamping the leaflets, the anterior and posterior leaflets are forced toward each other and secured together when the clamp is closed, tending to pull the leaflets too far, which can lead to serious consequences of leaflet dysfunction, clamp drop, or even leaflet tearing.

The prior art discloses a scheme of adding a polymer elastomer in involutive forceps arms, and the degree of traction of the valve forceps to valve leaflets is adjusted through the existence of the elastomer. However, since the leaflet tissue is slimy and always in a pulsatile state, when the leaflets are clamped by the cooperation between the rigid clamp arms and the elastic body, the clamping force may be insufficient, resulting in easy slippage of the valve clamp; in addition, for patients with small leaflet spacing, the presence of the elastomer may lead to undesirable leaflet stretch after coaptation and inadequate treatment of mitral regurgitation.

Disclosure of Invention

In view of the above, the present invention provides an adjustable valve clamping system, in which the valve clamping device has sufficient clamping force to avoid slipping when clamping valve tissue, and can adjust the pulling degree of the clamped valve tissue according to the requirement.

In order to solve the technical problems, the invention provides an adjustable valve clamping system, which comprises a pushing device and a valve clamp, wherein the valve clamp comprises a clamp main body and a clamp adjusting mechanism, the clamp main body comprises a fixed seat, a far-end clamping piece capable of being opened and closed relative to the fixed seat, and a near-end clamping piece arranged between the fixed seat and the far-end clamping piece; the fixing seat is detachably connected to a pushing device so as to push the clamping device main body through the pushing device, and the far-end clamping piece is matched with the near-end clamping piece to clamp valve tissues; the clamping device adjusting mechanism is positioned between the pushing device and the fixed seat and comprises an adjusting piece which can slide to the fixed seat along the axial direction; when the clamping device main body is folded, the adjusting piece abuts against the near-end clamping piece so as to adjust the traction degree of the clamping device main body to the valve tissue.

According to the adjustable valve clamping system provided by the invention, the clamp body clamps valve tissues through the matching of the proximal clamping piece and the distal clamping piece, so that the clamp body can be ensured to have enough clamping force to avoid slipping; furthermore, when needed, the adjusting element is driven by the clamping device adjusting mechanism to slide to the near-end clamping piece sleeved on the fixed seat to prop against the clamping device main body in the folded state, so that the traction degree of the clamping device main body to valve tissues can be adjusted, and the mitral regurgitation of a patient with larger leaflet interval can be effectively treated.

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 it is obvious for those skilled in the art to obtain other drawings based on 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 connection between the valve clamping device and the pushing device according to the first embodiment of the present invention.

Figure 4 is a schematic view of the adjustment member of the valve binder device of figure 3 released into the holder.

Fig. 5 is a schematic view of the valve binder device of fig. 4 in a collapsed state.

Fig. 6 is a perspective view of the holder of the valve clamp of fig. 3.

Fig. 7 is a perspective view of a proximal clip of the valve clip of fig. 3.

Fig. 8 is a schematic view of the valve binder of fig. 5 implanted in a patient with a large leaflet spacing.

Fig. 9 is a schematic view of the mitral valve of fig. 8 after the valve binder has clamped the leaflets and the heart has contracted.

Fig. 10 is a schematic view of the mitral valve of fig. 8 at diastole after the valve clasper grasps the leaflets.

Fig. 11 is a perspective view of a portion of the structure of fig. 3.

Fig. 12 is a perspective view of the connector of fig. 11.

Fig. 13 is a perspective view of the adjusting member of fig. 11.

Fig. 14 is a schematic partial perspective view of a pushing device of a valve clamping system according to an embodiment of the present invention.

Fig. 15 is a cross-sectional view of the pusher of fig. 14.

Figures 16-20 are schematic views of the use of the valve clip.

Fig. 21 is a schematic structural view of a clamp main body and an adjusting member of a valve clamp according to a second embodiment of the present invention.

FIG. 22 is a schematic view of an adjusting member of the valve binder according to the third embodiment of the present invention.

Fig. 23 and 24 are schematic views of other embodiments of the adjustment member of fig. 22.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be obtained by a person skilled in the art without inventive effort based on the embodiments of the present invention, are within the scope of the present invention.

In the description of the present invention, it should be noted that the terms "upper", "lower", "inside", "outside", and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience in describing the present invention and simplifying the description, but do not indicate or imply that the referred device or element 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," 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 should be noted that, in the field of interventional medical devices, the proximal end refers to the end closer to the operator, and the distal end refers to the end farther from the operator; axial refers to a direction parallel to the line joining 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, a first embodiment of the present invention provides an adjustable valve clamping system, which includes a valve clamp and a pushing device for delivering the valve clamp, wherein the valve clamp includes a clamp body 100 for clamping valve tissue and a clamp adjusting mechanism 200 for adjusting a pulling degree of the clamp body 100 to the valve tissue. The clip body 100 includes a holder 10, a distal clip 20 openable with respect to the holder 10, and a proximal clip 30 disposed between the holder 10 and the distal clip 20. The fixing base 10 is detachably connected to the pushing device 300, so as to push the folder body 100 through the pushing device 300. The distal clip 20 cooperates with the proximal clip 30 to grip valve tissue. The clamping device adjusting mechanism 200 is located between the pushing device 300 and the fixing base 10, the clamping device adjusting mechanism 200 includes an adjusting member 40 that can slide along the axial direction to be sleeved on the fixing base 10, when the clamping device main body 100 is folded, the adjusting member 40 abuts against the proximal end clamping piece 30 to adjust the drawing degree of the clamping device main body 100 to the valve tissue.

In this embodiment, the number of the distal clips 20 and the number of the proximal clips 30 are two, the two distal clips 20 and the two proximal clips 30 are in one-to-one correspondence to form two clamps, the two clamps are axially symmetrically arranged with respect to the fixing base 10, and after the valve clamp is implanted into a patient, the two clamps can respectively clamp the anterior leaflet and the posterior leaflet of the mitral valve, so as to alleviate or treat the mitral regurgitation. Each clamp clamps valve tissue through the cooperation of the proximal clip 30 and the distal clip 20, which can ensure that the clamp body 100 has enough clamping force to avoid slipping; furthermore, when necessary, the adjusting element 40 of the clip adjusting mechanism 200 can slide to the proximal clip 30 sleeved on the fixing base 10 to prop against the clip main body 100 in the closed state, so as to reduce the pulling degree of the clip main body 100 to the valve tissue, thereby effectively treating the mitral regurgitation of the patient with larger leaflet spacing.

In order to ensure the safety after implantation, the fixing base 10, the distal clip 20 and the proximal clip 30 are all made of biocompatible metal materials, and the metal materials are selected from common implantation metal materials such as stainless steel, cobalt alloy, cobalt-chromium alloy, titanium alloy or nickel-titanium alloy, and preferably stainless steel or cobalt-chromium alloy with high hardness.

Specifically, referring to fig. 3, fig. 4 and fig. 6, the fixing base 10 includes a first base 11 located at a proximal end, a second base 12 located at a distal end, and a third base 13 for transitionally connecting the first base 11 and the second base 12. In this embodiment, the first seat 11, the second seat 12 and the third seat 13 are an integral structure. Obviously, in other embodiments, the first seat 11, the second seat 12 and the third seat 13 may be a non-integral structure.

In this embodiment, the first seat 11 is a circular tube with two axially-through end surfaces. The outer wall of the proximal end of the first seat 11 is provided with at least one connection hole 113 communicating with the lumen of the first seat 11, and the at least one connection hole 113 is used for detachably connecting the fixing seat 10 to the pushing device 300. At least one protrusion 115 with an inclined proximal surface is protruded from the outer wall of the distal end of the first seat 11, and the at least one protrusion 115 is used to fix the adjusting element 40 sleeved on the fixing seat 10. The number of the connection holes 113 and the bumps 115 is two.

In this embodiment, the second base 12 is a square structure. The second seat 12 is provided with a receiving cavity 14 penetrating through two opposite side surfaces of the second seat 12 along a direction perpendicular to the axial direction. The other two opposite side surfaces of the second seat 12 are respectively provided with a rectangular block 121 in a protruding manner. The second seat 12 has a through hole axially formed on the inner wall of the distal end of the accommodating cavity 14, and the axis of the through hole is collinear with the axis of the lumen of the first seat 11.

In this embodiment, the third seat 13 is substantially a step structure, and a cross section of the third seat 13 along any position perpendicular to the axial direction is square, and a cross sectional area of the third seat gradually increases from the proximal end to the distal end. The periphery of the third seat 13 includes two opposite planes and two opposite inclined planes, the two opposite planes of the third seat 13 are respectively provided with a connecting block 131 in a protruding manner, and the connecting block 131 is provided with a pin hole.

Further, the third seat 13 is axially provided with a through hole (not shown), and the lumen of the first seat 11, the through hole of the third seat 13, the accommodating cavity 14 of the second seat 12 and the through hole at the distal inner wall of the accommodating cavity 14 are coaxially communicated to form a through passage 15.

Referring to fig. 3 to 6, the clamping device body 100 further includes a push rod 50, and the push rod 50 axially slidably penetrates through the through channel 15 of the fixing base 10. In this embodiment, the push rod 50 is a circular rod. The proximal end of the push rod 50 is externally threaded (not shown) for connection to a mandrel (not shown) of the pushing device 300. The far end of the push rod 50 is provided with a connecting seat 55, the connecting seat 55 comprises two opposite first planes and two connecting surfaces connected with the two first planes, and the two connecting surfaces comprise a curved surface positioned at the far end and a second plane positioned at the near end and connected with the curved surface in a smooth transition manner. A pair of pin holes penetrating the two first planes are respectively formed at two opposite ends of the connecting seat 55. The section size of the connection seat 55 parallel to the second plane direction gradually decreases from the proximal end to the distal end, that is, the connection seat 55 is shaped like any one of a hemisphere, a spherical crown or a bullet, so that the clip main body 100 can be pushed in vivo more easily.

The push rod 50 and the connecting seat 55 may be an integral structure or a non-integral structure. In this embodiment, the push rod 50 and the connecting seat 55 are integrated, and the outer surfaces of the push rod 50 and the connecting seat 55 are smooth, so as to avoid damaging valve tissue or hooking chordae tendineae.

In order to ensure the safety after implantation, the push rod 50 and the connecting seat 55 are made of biocompatible materials such as polyester, silicone, stainless steel, cobalt alloy, cobalt-chromium alloy or titanium alloy, preferably stainless steel or cobalt-chromium alloy with higher hardness.

It should be noted that, a locking member is disposed in the accommodating cavity 14 of the fixing seat 10, and the push rod 50 is fixed or unlocked relative to the fixing seat 10 by the locking member, and the locking member may be a combination of a deformable elastic sheet and a steel sheet in the prior art, and therefore, the improvement and creation of the present invention are not related, and further description is omitted here.

Referring to fig. 3 and 7, the proximal clip 30 includes a connecting end 31 and a free end 32, and the connecting end 31 is fixed relative to the fixing base 10. In this embodiment, the two proximal clips 30 are connected into a whole by a connecting frame 33, the connecting frame 33 is provided with a through hole 34 for the push rod 50 to pass through, two opposite sides of the connecting frame 33 are further provided with rectangular holes 35 for the rectangular blocks 121 on the second seat 12 to pass through, and the connecting frame 33 is sleeved on the outer sides of the second seat 12 and the third seat 13 to relatively fix the connecting ends 31 of the two proximal clips 30 to the fixing seat 10. Obviously, in other embodiments, the connecting end 31 of the proximal clip 30 can be directly fixed to the fixing base 10 by welding, crimping, or the like.

The proximal clip 30 is at least partially made of an elastic material having a shape memory function and is heat set. In a natural state, the proximal clips 30 extend radially outward relative to the fixing base 10, and preferably extend proximally so as to cooperate with the distal clips 20 to clamp the valve tissue, that is, an included angle between two proximal clips 30 in a natural unfolded state should be slightly larger than an included angle between two distal clips 20, that is, an included angle between a length direction of the proximal clip 30 and an axial direction of the fixing base 10 is larger than or equal to an included angle between the distal clip 20 corresponding to the side and the fixing base 10 when the distal clip 20 is completely opened relative to the fixing base 10, so that the free end 32 of each proximal clip 30 and the corresponding distal clip 20 are close to each other and have a certain clamping force, so as to provide a more stable clamping force. Specifically, in the embodiment, the angle between the length direction of the proximal clips 30 and the axial direction of the fixing base 10 is in the range of 0-150 degrees, that is, in a natural state, the angle between the two proximal clips 30 can be up to 300 degrees, and the angle between the two proximal clips 30 is preferably 240 degrees, more preferably 160-200 degrees.

In this embodiment, the proximal clip 30 is made entirely of a super-elastic nickel-titanium alloy, thereby providing a spring force to the proximal clip 30 to urge the proximal clip 30 toward the distal clip 20 to clamp the valve tissue. In addition, in this embodiment, the connecting frame 33 may also be made of elastic nitinol and the proximal clip 30 by integral molding, so as to reduce the difficulty of the production process, simplify the process flow, and reduce the production cost; furthermore, the elastic connecting frame 33 is more easily sleeved on the outer sides of the second seat 12 and the third seat 13.

It should be noted that the free end 32 of the proximal clip 30 is provided with an adjusting wire hole 36 for connecting an adjusting wire (not shown) of the pushing device 300, and the free end 32 of the proximal clip 30 can be controlled by the adjusting wire extending to the outside of the patient. In the conveying state, the free end 32 of the near-end clamping piece 30 is tensioned by the adjusting wire and is attached to the surface of the fixed seat 10; after the free ends 32 are released by releasing the adjusting wires, the proximal clips 30 are released, and the proximal clips 30 restore to their natural state due to their elastic memory and press the valve tissue against the distal clips 20.

Further, the proximal clip 30 further comprises a first surface facing the distal clip 20, the first surface being provided with a grip enhancing member to increase the friction between the proximal clip 30 and the valve tissue, thereby improving the grip of the clip body 100 on the valve tissue. Specifically, in this embodiment, the gripping enhancement features are two spaced rows of barbs 37 disposed on opposite sides of the first surface. The barbs 37 may be formed integrally with the proximal clip 30 or the barbs 37 may be formed of the same or different material as the proximal clip 30 and attached to the first surface of the proximal clip 30, for example, a nitinol wire or rod may be secured to the first surface by a sleeve. The root of the barb 37 is connected to the proximal jaw 30 and the end of the barb 37 opposite the root is free, the free end of the barb 37 facing the distal jaw 20 in the naturally extended position. The included angle between the extending direction of the barbs 37 and the first surface is smaller than or equal to 90 degrees so as to enhance the clamping force of the valve clamping device on valve tissues. The free end of each barb 37 is a smooth arcuate surface to avoid damaging valve tissue.

In other embodiments, the grip-enhancing member may be a protrusion, a boss, or other irregularly distributed protrusions protruding from the first surface, a rough surface at least partially covering the first surface, or a combination thereof.

Preferably, the proximal clip 30 may further be applied with an active drug, or may be provided with at least one opening 38 to reduce the weight of the proximal clip 30, prevent the overweight clamp body 100 from slipping or damaging valve tissue due to long-term falling under the valve tissue, and facilitate the creeping and growing of endothelial cells.

Referring to fig. 4 and 5, in the present embodiment, the clamp body 100 further includes a pair of connecting rods 57 oppositely disposed, each distal clip 20 is connected to the connecting seat 55 at the distal end of the push rod 50 through the connecting rod 57 at a corresponding side, and when the push rod 50 slides axially in the through channel 15 of the fixing base 10, the connecting rod 57 can drive the distal clip 20 to open and close relative to the fixing base 10.

Specifically, each distal clip 20 includes a connecting section 21 located at the distal end and a clamping section 22 connected to the proximal end of the connecting section 21, one end of the connecting section 21 far away from the clamping section 22 is rotatably connected to the connecting block 131 of the third housing 13 of the fixing base 10, one end of the connecting section 21 close to the clamping section 22 is rotatably connected to the proximal end of the connecting rod 57 on the corresponding side, and the distal end of the connecting rod 57 is rotatably connected to the connecting seat 55 by means of a rotating pin or a bolt.

As mentioned above, the push rod 50 is unlocked from the fixing base 10 by the locking member in the receiving cavity 14, the push rod 50 can slide axially toward the distal end to move relative to the fixing base 10, so that the connecting seat 55 at the distal end of the push rod 50 moves relative to the fixing base 10, the connecting seat 55 drives the connecting rod 57 to move, under the pulling of the connecting rod 57, the distal clip 20 can rotate around the pin hole on the connecting block 131 to open relative to the fixing base 10, and after the proximal clip 30 between the fixing base 10 and the distal clip 20 is released, the proximal clip 30 approaches the distal clip 20 and cooperates with the distal clip 20 to clamp the valve tissue therebetween. After the proximal clip 30 and the distal clip 20 clamp the valve tissue, the push rod 50 is driven to move axially toward the proximal end, the connecting rod 57 drives the distal clip 20 to close relative to the fixing base 10 until the distal clip 20 is completely closed relative to the fixing base 10, so that the clamp body 100 is in a folded state, and then the push rod 50 and the fixing base 10 are fixed relative to each other through the locking member, so as to prevent the distal clip 20 from opening relative to the fixing base 10, and the clamp body 100 in the folded state falls below the valve.

It can be understood that the connecting seat 55 at the distal end of the push rod 50 moves along the axial direction to drive the connecting rod 57 to move up and down and open and close relative to the fixing seat 10, and then the connecting rod 57 drives the distal end clip 20 to open and close relative to the fixing seat 10, and this moving structure can realize that the distal end clip 20 opens and closes relative to the fixing seat 10 in a larger range. In some embodiments, the included angle between the clamping sections 22 of the two distal clips 20 can reach 300 degrees at most, that is, after the distal clips 20 are opened relative to the fixing base 10, a certain degree of downward turning can be realized, so that the clamping sections 22 can clamp valve tissues in continuous motion conveniently, and the clamping success rate is improved. In this embodiment, the included angle between the clamping sections 22 of the two distal clips 20 is preferably in the range of 0-240 degrees, and more preferably in the range of 120-180 degrees.

Preferably, a clamping anti-slip structure (not shown) may be disposed on a second surface of the distal clip 20 facing the proximal clip 30 to enhance friction when the distal clip 20 contacts the valve tissue, so as to provide a stable clamping force and prevent the distal clip 20 from damaging the valve tissue. The clamping anti-skid structure can be a bulge, a groove or a gasket which is attached to the second surface and is made of a biocompatible material with a higher friction coefficient.

Wherein, the second surface of the distal clip 20 may be a plane or a curved surface. Preferably, the second surface is provided with a curved surface to increase the contact area of the distal clip 20 with the valve tissue, thereby providing a stable clamping force. Moreover, the second surface of the curved surface forms a receiving groove, when the proximal clip 30 is drawn towards the distal clip 20, the barb 37 on the first surface of the proximal clip 30 can be received in the receiving groove to compress the valve tissue, and the volume of the clip main body 100 when it is folded can be reduced as much as possible, which is beneficial to the in vivo transportation.

It is further preferred that the second surface of the distal clip 20 is also coated with an active agent or has at least one opening.

It should be noted that the distal clip 20 has certain dimensional specifications to ensure a stable clamping force and to correspond to the size of the valve. When the length of the distal clip 20 is too long, the distal clip 20 is easy to clip too many anterior and posterior leaflets together, when the binder body 100 is folded, the two leaflets are forcibly pulled toward each other and fixed together, when the heart beats and the leaflets move, the too many leaflets are restricted to move, which is easy to cause abnormal mitral valve function and may also cause serious consequences such as tearing of the leaflets; when the distal clip 20 is too short, the main body 100 of the clip can only hold a small portion of the valve leaflet, so that the valve leaflet can easily slip out and the clipping and fixing effect is poor. In the present invention, the axial length of the distal clip 20, i.e. the distance from the connecting section 21 to the clamping section 22, should be greater than or equal to 4mm, preferably 6-10 mm. Too narrow a width of the distal clip 20 can easily cause damage to the leaflets, and too wide a width of the distal clip 20 can affect leaflet movement. In the present invention, the width of the distal clip 20, i.e., the length in the direction perpendicular to the axial direction of the distal clip 20, should be greater than or equal to 2mm, preferably 4-6 mm.

The valve claspers provided by the present embodiments can be used to reduce or treat "mitral regurgitation". Specifically, referring to fig. 8 to 10 together, the clip body 100 is placed at the position of the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve where they cannot be normally involuted, such that the corresponding proximal clip 30 and the distal clip 20 clamp the edge of the anterior leaflet 1a of the mitral valve, and the corresponding proximal clip 30 and the distal clip 20 clamp the edge of the posterior leaflet 1b of the mitral valve, so as to clamp the position of the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve where they cannot be normally involuted, and the direction of the arrow shown in fig. 9 and 10 is the blood flow direction. As shown in fig. 9, when the heart contracts, the anterior leaflet 1a and the posterior leaflet 1b are folded, and the position where the anterior leaflet 1a and the posterior leaflet 1b can not be normally combined is partially or completely folded, the opening area a of the mitral valve becomes small or is completely closed, and only a small amount of blood flows back from the opening of the mitral valve into the left atrium, so that the "mitral regurgitation" can be alleviated or treated. As shown in fig. 10, 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 clamps, 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 some embodiments, as shown in fig. 8, when the valve clip provided by the present invention is used to relieve or treat "mitral regurgitation" in a patient with large leaflet spacing, the operator releases the adjusting element 40 and places it inside the clip main body 100 as required to adjust the degree of pulling of the clip main body 100 on the leaflets, so as to avoid the serious consequences of leaflet dysfunction, leaflet falling off of the clip main body 100 or even leaflet tearing due to excessive pulling of the leaflets.

Referring to fig. 3 to 5, in order to effectively treat mitral regurgitation of different patients with different leaflet spacing differences, the valve binder is provided with a binder adjusting mechanism 200, and the binder adjusting mechanism 200 is located between the pushing device 300 and the fixing seat 10 of the binder main body 100. The clamping device adjusting mechanism 200 comprises an adjusting element 40 capable of being selectively released, when an operator judges that the valve leaflet interval of a patient is reasonable through a medical imaging device such as ultrasonic and the like, the valve tissue can be clamped through the matching of the distal end clamping piece 20 and the proximal end clamping piece 30 without releasing the adjusting element 40, and the clamping device main body 100 is placed in the patient after being folded; when the operator determines that the valve leaflet interval of the patient is too large, the adjusting element 40 is released, the adjusting element 40 slides to be sleeved on the fixing seat 10 along the axial direction, and after the clamp main body 100 clamping the valve tissue is folded, the adjusting element 40 is positioned in the clamp main body 100 and abuts against the proximal end clamping piece 30 so as to adjust the traction degree of the clamp main body 100 to the valve tissue.

Specifically, referring to fig. 3, fig. 4, and fig. 11 to fig. 13, a connecting member 60 is disposed at a distal end of the pushing device 300, the pushing device 300 is detachably connected to the fixing base 10 through the connecting member 60, a through hole 41 penetrating through both ends of the adjusting member 40 is axially formed in the adjusting member 40, and the adjusting member 40 is axially slidably sleeved outside the connecting member 60 and can slide along the connecting member 60 to be sleeved on the fixing base 10.

The connecting member 60 is substantially tubular, at least one sliding rail 61 is axially disposed on an outer wall of the connecting member 60, and the sliding rail 61 is used for guiding the adjusting member 40 sleeved outside the connecting member 60 to slide along the sliding rail 61. The distal end of the connecting member 60 is provided with at least two connecting rods 63, and the distal end of each connecting rod 63 is provided with a buckle 65 for detachably connecting with the fixed seat 10. In this embodiment, the outer wall of the connecting member 60 is provided with a set of sliding rails 61 in an axisymmetric manner, and the distal end of the connecting member 60 is provided with a set of connecting rods 63 in an axisymmetric manner.

The inner surfaces of the two connecting rods 63, which are arranged in an axisymmetric manner, opposite to each other are arc surfaces which are in smooth transition connection with the inner cylindrical surface of the lumen of the connecting piece 60, and the distance from the arc surface of each connecting rod 63 to the axis of the connecting piece 60 gradually decreases from the proximal end to the distal end, that is, the distal end of each connecting rod 63 inclines towards the axis of the connecting piece 60, and the two connecting rods 63 gradually converge and approach from the proximal end to the distal end.

The connecting rod 63 is made of an elastic material, and when the connecting rod 63 is pushed radially outward along the connecting member 60, the distal end of the connecting rod 63 expands outward. As shown in fig. 11, the liner tube 90 of the pushing device 300 is movably disposed in the lumen of the connecting member 60, the liner tube 90 is driven to move towards the distal end, the liner tube 90 radially outwardly pushes the connecting rod 63, the buckle 65 of the connecting rod 63 expands outwardly and is clamped into the clamp hole 115 of the fixing base 10, so that the pushing device 300 is connected with the fixing base 10 through the connecting member 60; it can be understood that, when the liner tube 90 is withdrawn proximally, the connecting rod 63 rebounds due to its own elasticity, the distal end of the connecting rod 63 is folded toward the axial direction of the connecting element 60, the latch 65 exits the corresponding latch hole 115, and the connection state of the pushing device 300 and the fixing base 10 is released.

As shown in FIGS. 3 and 4, the clip connector adjustment mechanism 200 further includes a driving member 70, and a control wire 80 connected to the adjustment member 40, the driving member 70 being adapted to drive the adjustment member 40 to axially slide distally, and the control wire 80 being adapted to pull the adjustment member 40 to axially slide proximally. In this embodiment, the driving element 70 is an elastic element disposed between the pushing device 300 and the adjusting element 40, the elastic element is sleeved outside the connecting element 60, the proximal end of the elastic element is fixedly connected to the pushing device 300 by a detachable or non-detachable connection manner such as welding or clamping, and the distal end of the elastic element abuts against the adjusting element 40. In this embodiment, the control wire 80 is threaded through the adjustment member 40 and extends outside the patient's body. When the control wire 80 is pulled towards the proximal direction, the control wire 80 drives the adjusting member 40 to slide towards the proximal end along the axial direction, and the elastic member is compressed; when the control line 80 is released, the elastic member restores to the extended state and pushes the adjusting member 40 to slide toward the far end along the axial direction to the outside of the first seat 11 sleeved on the fixed seat 10, specifically, the near end of the fixed seat 10.

Wherein, the inner diameter of the through hole 41 of the adjusting member 40 is at least 0.02mm, preferably 0.05-2mm larger than the outer diameter of the first seat 11, so that the adjusting member 40 can slide relative to the first seat 11 under the push of the elastic member.

Wherein, the elastic member can be compressed or extended along the axial direction of the pushing device, and is usually selected from elastic elements such as leaf springs, springs or bellows. In this embodiment, the elastic member is a spring.

The control wire 80 is made of a single wire or a plurality of twisted wires such as a nickel-titanium wire, a stainless steel wire, or a high-strength polymer wire. In this embodiment, the control wire 80 is a single ni-ti wire, and the control wire 80 is set as a set and is axisymmetrically connected to the adjusting member 40, so that the tension on both sides of the adjusting member 40 is balanced, and the clamp main body 100 is prevented from swinging due to unbalanced tension.

Referring to fig. 11 and 13, a set of sliding grooves 411 corresponding to the sliding rails 61 of the connecting member 60 is formed on an inner wall of the through hole 41 of the adjusting member 40, when the adjusting member 40 is sleeved outside the connecting member 60, the sliding rails 61 are accommodated in the sliding grooves 411, and the adjusting member 40 slides towards a far end along the sliding rails 61 under the pushing of the elastic member, or slides towards a near end along the sliding rails 61 under the pulling of the control wire 80.

Wherein, the width of the sliding slot 411 is at least 0.02mm, preferably 0.05-3mm larger than the width of the sliding rail 61, so as to ensure that the adjusting member 40 can slide along the sliding rail 61.

The adjusting member 40 includes, in order from the proximal end to the distal end, a ferrule portion 42, a support portion 43, and a fixing portion 44. In this embodiment, the sleeve portion 42 and the support portion 43 are both cylindrical, the diameter of the sleeve portion 42 is smaller than that of the support portion 43, and a step surface (not shown) is formed between the sleeve portion 42 and the support portion 43. As shown in fig. 3, the distal end of the elastic element is sleeved outside the sleeve portion 42 and abuts against the step surface, so as to push the adjusting element 40 to slide along the slide rail 61 toward the distal end.

In other embodiments, the diameter of the sleeve portion 42 may be the same as that of the support portion 43, and a ring of locking grooves is formed at the proximal end of the sleeve portion 42 on the periphery of the through hole 41, and the elastic member is locked in the locking grooves to push the adjusting member 40 to slide axially and distally.

The support portion 43 is provided with at least one threading hole 45 for the control wire 80 to pass through. Specifically, in this embodiment, a set of threading holes 45 is axially symmetrically formed at one end of the supporting portion 43 close to the sleeve portion 42, and a set of control wires 80 respectively extend to the outside of the patient after penetrating through a corresponding threading hole 45. In other embodiments, the set of threading holes 45 may be opened at other reasonable positions of the supporting portion 43, for example, at the middle of the supporting portion 43 or near one end of the fixing portion 43.

The fixing portion 44 has at least one fixing groove or at least one fixing hole penetrating through an outer wall surface of the fixing portion 44 on an inner wall of the through hole 41, and the fixing groove or the fixing hole corresponds to the protrusion 115 of the first seat 11 of the fixing seat 10 one-to-one to fix the adjusting element 40 on the fixing seat 10. Specifically, in the embodiment, a set of fixing holes 46 communicating with the through hole 41 is symmetrically formed on the distal end of the fixing portion 44, and when the adjusting element 40 slides to be sleeved outside the first seat 11 along the slide rail 61 towards the distal end under the pushing of the elastic element, the protrusion 115 of the first seat 11 is clamped into the corresponding fixing hole 46, so that the adjusting element 40 is fixed on the fixing seat 10. The distal end of the fixing portion 44 may be provided with an inner chamfer at the edge of the through hole 41, so that the protrusion 115 with the inclined proximal end surface is clamped into the corresponding fixing hole 46.

Preferably, the fixing portion 44 is in an inverted frustum shape, and the diameter of the fixing portion 44 is gradually reduced from the proximal end to the distal end, so that the adjusting member 40 is fixed on the fixing seat 10 without affecting the relative opening and closing between the proximal clip 30 and the distal clip 20 and the fixing seat 10, thereby avoiding affecting the clamping effect of the clamp body 100.

The adjusting member 40 is an elastic structure made of a biocompatible polymer material, preferably a material such as dense silica gel. It will be appreciated that the adjustment member 40 may be made of a resilient porous material such as sponge.

Referring to fig. 3, 14 and 15, the adjustable valve clamping system provided in this embodiment includes a pushing device 300 and the valve clamp, and the valve clamp can be delivered to the mitral valve by the pushing device 300, and the valve clamp can be adjusted to a suitable position of the mitral valve. The pushing device 300 comprises an operating handle and a pushing assembly, wherein 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. Specifically, the pushing assembly includes the aforementioned connector 60, a liner tube 90 movably coaxially sleeved within the lumen of the connector 60, and a mandrel 93 movably coaxially sleeved within the liner tube 90. The operator can drive the liner 90 and the mandrel 93 to move or rotate relative to each other through an operating handle arranged outside the patient.

The spindle 93 is detachably connected to the push rod 50 for driving the push rod 50 to slide along the axial direction of the fixing base 10, so as to drive the distal clip 20 to open and close relative to the fixing base 10. In this embodiment, the mandrel 93 is a round rod body with a distal end provided with an internal threaded hole (not shown) for threaded connection with a stud at the proximal end of the push rod 50.

As mentioned above, the liner tube 90 is driven to move towards the distal end, that is, the buckle 65 at the distal end of the connecting member 60 can be pushed to expand outward, so that the buckle 65 is clamped into the corresponding buckle 113 of the fixing seat 10, thereby realizing the detachable connection between the connecting member 60 and the fixing seat 10; the liner tube 90 is withdrawn proximally, so that the connection between the connecting element 60 and the fixing base 10 can be released, which will not be described herein.

In other embodiments, the pushing assembly may not include the liner 90, and the overall diameter of the mandrel 93 or the diameter of the distal end portion of the mandrel 93 is larger, so that the distal end portion of the mandrel 93 can directly push the catch 65 at the distal end of the connector 60 to expand outward, that is, the mandrel 93 can be used for pushing the catch 65 at the distal end of the connector 60 to expand outward, and can also be used for driving the push rod 50 to slide along the axial direction of the fixing base 10.

Referring to fig. 14 and 15, in the present embodiment, the pushing assembly further includes a pushing conduit 95 and a fixing member 97 disposed at a distal end of the pushing conduit 95, and the connecting member 60, the liner 90 and the mandrel 93 coaxially sleeved together are sleeved in the pushing conduit 95 through the fixing member 97, so as to push through the pushing conduit 95.

The push catheter 95 includes an outer layer hose, a mesh grid, and an inner layer hose from outside to inside, a plurality of cavities extending along the axial direction of the push catheter 95 are formed in the inner layer hose in the circumferential direction, the cavities are used for threads such as the control wire 80 to pass through to extend to the outside of the patient body, and the specific structure of the push catheter 95 is similar to that of the existing push catheter, and details are not repeated here.

Further, the pushing device 300 further comprises the aforementioned adjustment wire for fixing the free end 32 of the proximal clip 30 to fit against the surface of the fixing base 10, and the adjustment wire extends to the outside of the patient through the lumen of the pushing catheter 95. Wherein, the adjusting line can be made of metal or polymer materials such as PTFE.

It should be noted that the pushing assembly and the valve clamp can be delivered to the patient using the existing adjustable curved sheath.

In other embodiments, the pushing assembly may not include the pushing catheter 95, the connecting member 60, the liner 90 and the mandrel 93 having a certain axial length may be directly conveyed into the patient through the adjustable curved sheath, and the adjusting wire and the control wire 80 may also be directly inserted into the adjustable curved sheath and reversely extend to the outside of the patient, which is not described herein.

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 comprises the following steps:

the first step is as follows: the adjusting member 40 is sleeved outside the connecting member 60, the adjusting member 40 is pulled towards the proximal end through the control wire 80, so that the adjusting member 40 compresses the elastic member, then the pushing assembly is detachably connected with the clamp main body 100 of the valve clamp, and the free end 32 of the proximal clip 30 is bound on the surface of the fixing seat 10 by using the adjusting wire. Specifically, as mentioned above, the liner tube 90 is used to push the buckle 65 at the distal end of the connecting element 60 outwards, so that the buckle 65 is clamped into the clamping hole 113 of the fixing seat 10, and the fixing seat 10 and the connecting element 60 of the pushing assembly are in a connected state; rotating the mandrel 93 of the pushing assembly to enable the mandrel 93 to be fixed with the push rod 50 in a threaded mode; the core shaft 93 is moved by the operating handle in the proximal direction to drive the push rod 50 to slide in the distal direction along the axial direction, and the distal clip 20 is driven to close relative to the fixing base 10, so that the clamp body 100 is in a completely folded state, and at this time, the proximal clip 30 and the distal clip 20 are both close to the surface of the fixing base 10 and keep the folded state 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 by the pusher assembly using a trans-atrial septum approach, as shown in fig. 16.

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

The fourth step: the mandrel 93 is moved in the proximal direction by operating the handle, so as to drive the push rod 50 to slide in the proximal direction, so as to drive the distal clip 20 to open relative to the fixing base 10, and adjust the direction of the clip main body 100, so that the distal clip 20 is perpendicular to the apposition line of the mitral valve.

The fifth step: the entire binder body 100 is withdrawn proximally, causing the distal clip 20 to hold the leaflets against the left ventricle side, as shown in fig. 17.

And a sixth step: releasing the binding of the adjusting wire to the proximal clip 30, the proximal clip 30 springs back to open relative to the holder 10, so that the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve are clamped between the corresponding proximal clip 30 and the distal clip 20, respectively, as shown in fig. 18.

The seventh step: through medical image observation such as ultrasonic, for a patient with a large distance between the anterior leaflet and the posterior leaflet, the control line 80 for controlling the adjusting piece 40 is loosened, the tension on the adjusting piece 40 is released, the adjusting piece 40 slides to be fixed on the fixed seat 10 towards the far end under the action of the elastic force of the elastic piece, and the convex block 115 on the fixed seat 10 is clamped in the fixing hole 46 of the adjusting piece 40, as shown in fig. 19; for patients with small anterior-posterior leaflet spacing, the release of the adjustment element 40 is not required, and the compression of the elastic element is maintained to prevent the release of the adjustment element 40.

Eighth step: moving the mandrel 93 to the distal direction again, the mandrel 93 drives the push rod 50 to slide axially to the distal end, so as to drive the distal clamping piece 20 to close relative to the fixing seat 10 until the clamp body 100 is completely folded, as shown in fig. 20;

the ninth step: the mandrel 93 is controlled to rotate by operating the handle, so that the threaded connection between the mandrel 93 and the push rod 50 is unlocked, the liner tube 90 and the mandrel 93 are withdrawn towards the near end until the buckle 65 at the far end of the connecting piece 60 is unlocked and separated from the clamping hole 115 of the fixed seat 10, and the clamp main body 100 is completely separated from the pushing assembly. Finally, the pusher assembly is withdrawn from the patient, at which point the clip body 100 pulls the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve toward each other, resulting in a bi-foraminous mitral valve, completing the edge-to-edge repair of the mitral valve. In the case of releasing the adjustment member 40, the adjustment member 40 is released inside the clip main body 100 to stay with the clip main body 100 inside the patient, as shown in fig. 8; for those instances where it is not necessary to release the adjustment member 40, the operator may withdraw the adjustment member 40 out of the patient's body along with the pushing assembly via the control wire 80, leaving only the clip body 100 in the patient's body, completing the edge-to-edge repair of the mitral valve.

It will be appreciated that the valve clamping system of the present invention may also be used to deliver a valve clamp to the mitral valve via transapical or other routes.

The adjustable valve clamping system can clamp the valve leaflets by matching the proximal clamping piece 30 and the distal clamping piece 20, has enough clamping force and avoids the clamp main body 100 from slipping; furthermore, according to the distance between the mitral valve leaflets of a patient, the adjusting element 40 can be selectively released or not released, so as to treat the mitral regurgitation of the patient with different leaflet distances, when the adjusting element 40 is released and fixed on the fixing base 10, the adjusting element 40 is positioned in the inner part of the clamping device main body 100 when the clamping device main body 100 is folded, the adjusting element 40 is filled between the anterior leaflet and the posterior leaflet of the clamped mitral valve and is abutted against the proximal clip 30, the elastic adjusting element 40 can be extruded and deformed along with the pulsation of the leaflets, the adjusting element 40 generates elastic force to push the part of the leaflets close to the adjusting element 40 to the direction far away from the fixing base 10, so that the clamping angle between the anterior leaflet and the posterior leaflet of the mitral valve is smaller than the opening angle between the distal clip 20, and the elastic adjusting element 40 has a buffer effect on the pulsating leaflets, so as to reduce the pulling of the leaflets by the clamping device main body 100, and keep the degree of the leaflets pulling of the clamping device main body 100 to the leaflets within a, the mitral regurgitation of a patient with large leaflet spacing can be effectively treated, and the leaflets are prevented from being damaged by excessive traction; in addition, the adjusting member 40 can buffer the direct flushing of blood flow to the inside of the clamp body 100, so as to prevent the clamp body 100 from falling off due to continuous flushing of blood, and prevent blood from accumulating at dead angles between the proximal clips 30 of the clamp body 100 to form thrombus.

Referring to fig. 21, the structure of the valve clip according to the second embodiment of the present invention is similar to that of the valve clip according to the first embodiment, except that: in the second embodiment, at least one of the adjusting member 40, the proximal clip 30 and the distal clip 20 is covered with a covering film, and specifically, in the present embodiment, the adjusting member 40, the proximal clip 30 and the distal clip 20 are covered with a first covering film 410, a second covering film 420 and a third covering film 430, respectively.

Wherein the first covering membrane 410 completely covers the outer surface of the adjustment member 40, the second covering membrane 420 at least partially covers the first surface of the proximal clip 30, and the third covering membrane 430 at least partially covers the second surface of the distal clip 20. Preferably, in this embodiment, the second membrane 420 completely covers the first surface of the proximal clip 30 and extends to completely cover the surface of the proximal clip 30 opposite the first surface, such that only the barbs 37 of the proximal clip 30 extend through the second membrane 420; the third coating film 430 completely covers the second surface of the distal clip 20 and extends to completely cover the surface of the distal clip 20 opposite to the second surface, and the third coating film 430 covering the two distal clips 20 covers the outer surfaces of the connecting portions (i.e., the connecting seat 55 and the connecting rod 57) of the two distal clips 20.

The first coating 410, the second coating 420, and the third coating 430 are fixed by any means such as sewing, dip coating, bonding, fusing, or binding. In this embodiment, the first covering membrane 410 and the second covering membrane 420 are respectively bonded and fixed to the adjusting member 40 and the proximal clip 30, and the third covering membrane 430 is sewn and fixed to the distal clip 20.

The first coating 410, the second coating 420 and the third coating 430 are made of at least one layer of biocompatible polymer material with oxidation resistance and dissolution resistance, wherein the polymer material is at least one selected from PET, polyester, PTFE, silicone, silica gel or urethane. The materials of the first coating 410, the second coating 420, and the third coating 430 may be the same or different. In this embodiment, the first coating 410, the second coating 420, and the third coating 430 are preferably single-layer PET coatings.

Further, the first coating film 410, the second coating film 420, and the third coating film 430 each have one or two or more of two-dimensional screen structures, porous film bodies, microporous structures, woven or non-woven mesh structures, foamed structures, and the like. In this embodiment, the covering films have a mesh structure, a plurality of meshes are formed in each of the first covering film 410, the second covering film 420, and the third covering film 430, and the aperture ratio (i.e., the percentage of the aperture area in the entire covering film area) of the first covering film 410, the second covering film 420, and the third covering film 430 is sequentially reduced. Further, the meshes of the first cover 410 may not pass blood and thrombus, and the meshes of the second cover 420 and the third cover 430 may pass blood and prevent thrombus.

In this embodiment, the first coating 410 not only can increase the biocompatibility of the adjusting element 40, avoid tissue allergy and inflammatory reaction, and improve the safety of the product, but also can form an artificial barrier on the atrial side of the valve leaflet by the adjusting element 40 having the first coating 410, block thrombus in blood, close the opening of the whole clip main body 100 facing the atrial side, and avoid thrombus formation due to repeated washing of blood at the internal dead angle of the clip main body 100, thereby avoiding thrombus.

The second and

third cover films

420 and 430 can wrap the metal surface and/or sharp edges of the clamp body 100, so as to avoid damaging the clamped valve tissue; moreover, the second film 420 and the third film 430 can increase the blocking force applied during the blood circulation, so as to reduce the blood pressure difference between the left atrium and the left ventricle; in addition, the second coating 420 can increase the contact area between the proximal clip 30 and the blood to buffer the inflowing blood, so that the inflow blood is prevented from impacting the clamp body 100 to deform the proximal clip 30 to cause slippage as much as possible, and the third coating 430 can also block a small amount of thrombus entering the clamp body 100 through the second coating 420 to be retained in the clamp body 100, so as to prevent the thrombus from entering the left ventricle and entering the blood circulation of the human body to induce stroke.

The aperture ratio of the third coating film 430 is large, so that the third coating film 430 has good elasticity and elongation, when the distal clip 20 covered with the third coating film 430 is opened and closed relative to the fixing base 10, the third coating film 430 can generate corresponding elastic deformation along with the opening and closing of the distal clip 20, and the third coating film 430 is attached to the distal clip 20 all the time.

Preferably, in this embodiment, the aperture of the mesh of the third coating 430 covering the proximal region (i.e., the clamping section 22) of the distal clip 20 is small, and the third coating 430 in this region has high compactness, so that the third coating is not easily worn by the proximal edge of the distal clip 20 and does not affect the opening and closing of the distal clip 20; the aperture of the mesh of the third coating 430 covering the distal region (i.e., the connecting section 21) of the distal clip 20 is relatively large, and the elasticity and the elongation of the third coating 430 in this region are relatively good, so that even under the condition of a relatively large opening and closing angle, the third coating 430 close to the fixing base 10 can deform correspondingly along with the opening and closing of the distal clip 20, thereby ensuring that the third coating 430 is attached and fixed to the distal clip 20.

Referring to fig. 22 to 24, a third embodiment of the present invention provides a valve clip device having a structure similar to that of the first embodiment, except that: in the third embodiment, the regulating member 40c is a mesh cage structure made of a biocompatible metal material selected from stainless steel, nitinol, or cobalt-chromium alloy having some elasticity. It will also be appreciated that the adjustment element 40 may also be a mesh cage structure woven from an elastic material such as nickel titanium wire to increase the elasticity of the adjustment element 40 to improve leaflet flexibility and reduce the outer diameter during delivery. Specifically, the adjusting member 40c of the cylinder mould structure comprises a woven net 47, and a connecting pipe 48 and a fixing pipe 49 which are respectively connected to two opposite ends of the woven net 47, wherein the fixing pipe 49 is used for detachably connecting the fixing base 10. In this embodiment, the fixing tube 49 has a set of fixing holes 491 axially symmetrically, and the fixing holes 491 cooperate with the protrusions 115 of the fixing base 10 to clamp the adjusting member 40c on the fixing base 10.

In order to prevent the adjusting element 40c from affecting the relative opening and closing between the proximal clip 30 and the distal clip 20 and the fixing seat 10 after being fixed to the fixing seat 10, and further affecting the clamping effect of the clamp body 100, the diameter of the distal end portion of the mesh grid 47 is gradually reduced from the proximal end to the distal end. As shown in fig. 22, in the present embodiment, the middle portion of the mesh grid 47 is cylindrical, the opposite ends are cones, and the cone angles of the cones at the two ends are the same. In other embodiments, the woven mesh 47 may have other reasonable shapes, for example, a fusiform structure with the same taper angle at both ends as shown in fig. 23, or a structure with different taper angles at both ends as shown in fig. 24, as long as the diameter of the distal end portion of the woven mesh 47 is gradually reduced without affecting the holding effect of the clip body 100.

Specifically, when the adjusting member 40c in this embodiment is manufactured, 12 to 36 nickel-titanium wires with a diameter of 0.05 to 0.08mm are wound on a lining rod to be woven into a cylindrical woven mesh 47, one end of the cylindrical woven mesh 47 is inserted into a connecting pipe 48 made of a stainless steel pipe, and the nickel-titanium wires and the connecting pipe 48 are connected together by crimping or welding; then, the opening end of the straight woven mesh 47 is plugged into a shaping mold, and the opening end is wound into a bundle by using stainless steel wires; placing the weaving net 47 and the shaping mold into an electric heating type circulating air box furnace, and carrying out shaping heat treatment for 12-18 minutes under the conditions of 450-650 ℃ (preferably 500 ℃); taking out and cooling to room temperature, removing the stainless steel wire, and taking out the shaping mold to obtain a shaping net; and plugging the nickel-titanium wires at the opening end of the sizing net into a fixed pipe 49 made of stainless steel, and performing compression joint or welding to obtain the adjusting piece 40c with the net cage structure.

In this embodiment, the adjusting element 40c of the mesh cage structure has better elastic deformability, and can better adapt to the anatomical structure of the mitral valve, thereby avoiding the damage of the valve leaflet caused by excessively pulling the valve leaflet.

It should be noted that the above description is given by way of example of a valve clip for reducing or treating "mitral regurgitation". It is understood that, in other embodiments, the valve binder 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 binder used to solve "mitral regurgitation" in the embodiments of the present invention, and only a plurality of groups of proximal clips and distal clips are required to form a plurality of clamps, and each clamp respectively clamps one leaflet, which is not described herein again.

Obviously, in other embodiments, the valve clamping device provided by the invention can also be applied to other minimally invasive surgical operations needing to clamp more than three pieces of valve tissues together.

The foregoing is illustrative of embodiments of the present invention, and it should be noted that modifications and adaptations to those skilled in the art may be made without departing from the principles of the embodiments of the present invention and are intended to be within the scope of the present invention.

Claims

1. An adjustable valve clipping system, comprising a valve clipping device and a pushing device for delivering the valve clipping device, the valve clipping device comprising:

a clip body for gripping valve tissue;

the clamping device adjusting mechanism is positioned between the pushing device and the clamping device main body and comprises an adjusting piece which can slide to the clamping device main body along the axial direction in a sleeved mode; when the clamping device main body is folded, the adjusting piece props against the clamping device main body so as to adjust the traction degree of the clamping device main body to the valve tissue.

2. The adjustable valve clamping system of claim 1, wherein the clamp body comprises a holder detachably connected to the pushing device, a distal clip openable and closable with respect to the holder, and a proximal clip disposed between the holder and the distal clip, the distal clip and the proximal clip cooperating to clamp valve tissue; the clamping device adjusting mechanism is located between the pushing device and the fixed seat.

3. The adjustable valve clamping system according to claim 2, wherein a connecting member is disposed at a distal end of the pushing device, a through hole penetrating through both ends of the adjusting member is axially formed in the adjusting member, the pushing device is detachably connected to the fixing base through the connecting member, the adjusting member is sleeved outside the connecting member, and the adjusting member slides along the connecting member to be sleeved on the fixing base to abut against the proximal clamping piece.

4. The adjustable valve clamping system of claim 3, wherein the clamp adjustment mechanism further comprises a drive member for driving the adjustment member to slide in an axial direction.

5. The adjustable valve clamping system of claim 4, wherein the clamp adjustment mechanism further comprises a control wire connected to the adjustment member, and the driving member is an elastic member disposed between the pushing device and the adjustment member; pulling the control wire proximally to cause the adjustment member to slide axially proximally, the resilient member being compressed; and when the control wire is loosened, the elastic piece stretches and pushes the adjusting piece to slide towards the far end along the axial direction to the outside of the near end sleeved on the fixed seat.

6. The adjustable valve clamping system of claim 5, wherein the adjusting member comprises a clamping sleeve portion, a supporting portion and a fixing portion in sequence from a proximal end to a distal end, and the distal end of the elastic member is sleeved on the clamping sleeve portion.

7. The adjustable valve clamping system of claim 6, wherein the diameter of the clamping sleeve portion is smaller than that of the supporting portion, a step surface is formed between the clamping sleeve portion and the supporting portion, and the distal end of the elastic member abuts against the step surface.

8. The adjustable valve clamping system of claim 6, wherein the support portion defines at least one threading aperture, and the control wire passes through the threading aperture.

9. The adjustable valve clamping system of claim 6, wherein the diameter of the fixation portion decreases gradually from the proximal end to the distal end.

10. The adjustable valve clamping system according to claim 6, wherein the fixing portion has at least one fixing groove or at least one fixing hole penetrating through an outer wall surface of the fixing portion on an inner wall of the through hole, and the fixing seat has at least one protrusion on an outer wall thereof, wherein the protrusion is in one-to-one correspondence with the fixing groove or the fixing hole to fix the adjusting member to the fixing seat.

11. The adjustable valve clamping system of claim 5, wherein the elastic member is sleeved outside the connecting member, and a proximal end of the elastic member is connected to the pushing device.

12. The adjustable valve clamping system of claim 5, wherein the elastic member is compressible or expandable in an axial direction of the pusher.

13. The adjustable valve clamping system of claim 3, wherein at least one sliding rail is axially disposed on an outer wall of the connecting member, and at least one sliding groove is disposed on an inner wall of the through hole of the adjusting member corresponding to the at least one sliding rail.

14. The adjustable valve clamping system of claim 3, wherein the distal end of the connecting member is provided with at least two connecting rods, the distal end of each connecting rod is provided with a buckle for detachable connection with the fixing base, and the proximal end of the fixing base is provided with a clamping hole corresponding to the buckle.

15. The adjustable valve clamping system of claim 14, wherein the connecting rod is made of an elastic material, and when the catches of the connecting rod are pushed radially outward along the connecting member, the catches of the connecting rod expand outward to be caught in the corresponding catching holes.

16. The adjustable valve clamping system of claim 1, wherein the adjustment member is an elastic structure made of a biocompatible polymeric or metallic material.

17. The adjustable valve clamping system of claim 16, wherein the polymer material is selected from silica gel or sponge, and the metal material is selected from stainless steel, nitinol, or cobalt-chromium alloy.

18. The adjustable valve clamping system of claim 16, wherein the adjustment member is a mesh structure comprising a woven mesh, and a connecting tube and a stationary tube connected to opposite ends of the woven mesh, respectively, the stationary tube for removably connecting the valve clamp.

19. The adjustable valve clamping system of claim 1, wherein at least one of the adjustment member, the proximal clip, and the distal clip at least partially covers a covering membrane.

20. The adjustable valve clamping system of claim 19, wherein the adjustment member, the proximal clip and the distal clip cover a first cover membrane, a second cover membrane and a third cover membrane, respectively.

21. The adjustable valve clamping system of claim 20, wherein the cover membrane is a mesh structure, and the first cover membrane, the second cover membrane and the third cover membrane have sequentially decreasing aperture ratios.