WO2024093232A1

WO2024093232A1 - Stable-fitting valve clip device and valve clip system

Info

Publication number: WO2024093232A1
Application number: PCT/CN2023/098196
Authority: WO
Inventors: 张庭超; 郑贤章; 梁华光; 张伟伟
Original assignee: 杭州德晋医疗科技有限公司
Priority date: 2022-11-03
Filing date: 2023-06-05
Publication date: 2024-05-10
Also published as: CN117982268A

Abstract

The present application discloses a stable-fitting valve clip device (100) and valve clip system (1000). The stable-fitting valve clip device (100) comprises a support member (10), an adjustment member (30), and a clip member (50). The adjustment member (30) comprises a first narrowed end (31), a second narrowed end (32), an outer layer (33), an inner layer (34), and a flip layer (35). The first narrowed end (31) and the second narrowed end (32) are both sleeved on the outer side of the support member (10). The flip layer (35) is transitionally connected to one end of the inner layer (34) and the outer layer (33). The other end of the inner layer (34) is connected to at least one of the first narrowed end (31) and the second narrowed end (32). The first narrowed end (31) and the second narrowed end are fixedly arranged relative to the support member (10), or the first narrowed end (31) and the second narrowed end (32) are fixed relative to each other, and can move in a small range relative to the support member (10) in the axial direction of the support member (10).

Description

Valve clamping device and valve clamping system with stable fitting

This application claims the priority of the Chinese patent application filed with the China Patent Office on November 3, 2022, with application number 2022113947697 and application name “Stable-fitting valve clamping device and valve clamping system”, the entire contents of which are incorporated by reference into this application.

Technical Field

The present application relates to the technical field of medical devices, and in particular to a valve clamping device and a valve clamping system with stable fitting.

Background technique

Atrioventricular valves such as the mitral valve and tricuspid valve are one-way valves in the heart. Normal and healthy atrioventricular valves can control the flow of blood from the atrium to the ventricle, while preventing blood from flowing from the ventricle to the atrium. For example, the mitral valve is a one-way valve located between the left atrium and the left ventricle of the heart, which can control the flow of blood from the left atrium to the left ventricle, while preventing blood from flowing from the left ventricle to the left atrium. Specifically, the mitral valve includes a pair of leaflets, namely the anterior leaflet and the posterior leaflet. When the edges of the anterior leaflet and the posterior leaflet are aligned, the mitral valve can be completely closed to prevent blood from flowing from the left ventricle to the left atrium. When the leaflets of the mitral valve or its related structures undergo organic or functional changes, the anterior leaflet and the posterior leaflet of the mitral valve are not aligned well. As a result, when the left ventricle of the heart contracts, the mitral valve cannot be completely closed, causing blood to flow back from the left ventricle to the left atrium, thereby causing a series of pathological and physiological changes, known as "mitral valve regurgitation."

Surgical procedures usually use valve edge-to-edge suture and other surgical methods to treat mitral regurgitation. However, this type of surgery has the disadvantages of complex surgical procedures, high surgical costs, high degree of patient trauma, high risk of complications, long hospital stay, and painful recovery process for patients. Interventional valve clipping refers to the implantation of a valve clipping device into the mitral valve to pull the two leaflets that were originally poorly aligned toward each other, reduce or eliminate the leaflet gap, and thus treat regurgitation.

The valve clamping device in the prior art includes a clamping body, a support body and an elastic body. The elastic body is sleeved outside the support body and arranged between the two clamp arms of the clamp body, so that the leaflets on each side are clamped between one side of the clamp arm and one side of the elastic body, respectively, so that the spacing between the leaflets can be adapted by the deformation of the elastic body, and then the pulling degree of the leaflets by the clamp arm can be adjusted. The elastic body includes a deformable mesh body, one end of which is the lower end of the support body fixed between the two clamp arms, and the other end is a free end surrounding the upper end of the support body. However, when the two clamp arms are closed, the elastic body is squeezed and deformed to become circumferentially flattened and axially greatly lengthened, so that the free end of the elastic body is greatly displaced toward the upper end of the support body in the axial direction, which leads to the instability of the fitting position of the elastic body and the leaflet. In addition, because the free end of the elastomer is displaced upward significantly, the top of the elastomer is in a tapered shape, which makes it impossible for the top of the elastomer to fit the leaflet. The fitting height between the elastomer and the leaflet is limited and insufficient. The fitting area between the elastomer and the leaflet changes depending on the deformation of the elastomer, which leads to unstable radial support force and fitting state of the elastomer on the leaflet, thereby affecting the effect of treating reflux.

Summary of the invention

In view of this, the present application provides a valve clamping device and a valve clamping system with stable fitting, so as to solve the problem of unstable fitting state between the elastic body and the valve leaflet in the prior art.

In a first aspect, an embodiment of the present application provides a valve clamping device with stable fitting, comprising:

supporting item;

an adjusting member, wherein the adjusting member is sleeved on the supporting member; and

A clamping member is rotatably connected to the supporting member and is arranged outside the adjusting member and can be relative to the adjusting member. The adjusting member is expanded or closed;

The adjusting member is constructed as a three-dimensional structure with elasticity, and the adjusting member includes a first closing end, a second closing end, an outer layer, an inner layer and a flip layer arranged between the outer layer and the support member; the first closing end and the second closing end are both sleeved on the outer side of the support member, the flip layer transitionally connects one end of the inner layer and the outer layer, and the other end of the inner layer is connected to at least one of the first closing end and the second closing end;

The first closing end and the second closing end are fixedly arranged relative to the support member; or, the first closing end and the second closing end are fixed in relative position and can move within a small range relative to the support member along the axial direction of the support member.

In a second aspect, an embodiment of the present application provides a valve clamping system, comprising a delivery device and a valve clamping device with a stable fit as described above, wherein the delivery device is detachably connected to the valve clamping device.

The valve clamping device and valve clamping system provided in the embodiments of the present application are based on the first closing end and the second closing end of the adjusting member being sleeved on the outer side of the supporting member, the flip layer transitionally connecting one end of the inner layer and the outer layer, and the other end of the inner layer being connected to at least one of the first closing end and the second closing end. In this way, when the clamp is closed relative to the adjusting member to clamp the leaflet between the adjusting member and the clamp, since the first closing end and the second closing end are fixedly arranged relative to the support member, or the first closing end and the second closing end are fixed in relative position and can move in a small range relative to the support member along the axial direction of the support member, the inner layer will pull the flip layer in the axial direction, and the flip layer converts the axial pulling force of the inner layer on itself into a supporting force on the outer layer in the radial direction. The inner layer and the flip layer work together to limit the axial lengthening of the adjusting member when it is squeezed by the clamp, and limit the axial displacement of the flip layer. At the same time, the flip layer and the inner layer of the adjusting member can form a shape with a middle depression and convex edges around, avoiding the prior art in which the top of the elastomer is in a closing cone shape and does not fit the valve fully, thereby enabling the adjusting member and the leaflet to fit stably and fully, and the valve clamping device can firmly clamp the leaflet, reduce the risk of the leaflet falling off from between the clamp and the adjusting member, improve the implantation stability of the valve clamping device, and improve the surgical effect.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative labor.

FIG1 is a schematic structural diagram of a valve clamping device with stable fitting provided in the first embodiment of the present application, when the clamping parts are in an expanded state.

FIG. 2 is a schematic diagram of the partial structure of the adjusting member and the supporting member of the valve clamping device in FIG. 1 .

FIG. 3 is a schematic diagram of a partial structure of an adjusting member of the valve clamping device in FIG. 1 .

FIG. 4 is a schematic diagram of the three-dimensional structure of the adjusting member of the valve clamping device in FIG. 1 .

5 is a bottom view of the adjusting member of the valve clamping device in FIG. 4 .

FIG. 6 is a schematic structural diagram of the valve clamping device in FIG. 1 when the clamping member is in a first closed state.

FIG. 7 is a schematic structural diagram of the valve clamping device in FIG. 1 when the clamping member is in a second closed state.

8 to 12 are schematic diagrams of a scenario in which the valve clipping device in FIG. 1 is used to perform edge-to-edge repair of the mitral valve via a transcatheter approach.

FIG. 13 is a schematic structural diagram of a stably fitted valve clamping device provided in the second embodiment of the present application when the clamping parts are in an expanded state.

FIG. 14 is a schematic diagram of a partial structure of the valve clamping device of FIG. 13 .

FIG. 15 is a schematic structural diagram of the regulating member of the valve clamping device of FIG. 13 .

FIG. 16 is a schematic structural diagram of the valve clamping device of FIG. 13 when the clamping member is in a closed state.

FIG. 17 is a schematic diagram of the partial structure of a stably fitting valve clamping device provided in the third embodiment of the present application.

FIG. 18 is a schematic diagram of the partial structure of a stably fitting valve clamping device provided in the fourth embodiment of the present application.

FIG. 19 is a schematic structural diagram of a valve clamping device with stable fitting provided in the fifth embodiment of the present application when the clamping parts are in a closed state.

FIG. 20 is a schematic structural diagram of the adjusting member of the valve clamping device of FIG. 19 .

FIG. 21 is a schematic structural diagram of a valve clamping device with stable fitting provided in the sixth embodiment of the present application when the clamping parts are in an expanded state.

FIG. 22 is a schematic diagram of the partial structure of the valve clamping device of FIG. 21 .

FIG. 23 is a schematic structural diagram of the valve clamping device of FIG. 21 when the clamping member is in a closed state.

FIG. 24 is a schematic structural diagram of a stably fitted valve clamping device provided in the seventh embodiment of the present application when the clamping parts are in an expanded state.

FIG. 25 is a schematic diagram of the partial structure of the valve clamping device of FIG. 24 .

FIG. 26 is a schematic structural diagram of a valve clamping system provided in the eighth embodiment of the present application.

27-31 are schematic diagrams of a scenario in which the valve clipping system in FIG. 26 performs edge-to-edge repair of the mitral valve via the apical approach.

Main Components Symbols Description Valve Clipping System 1000, 2000
Valve clipping device 100, 100A, 100B, 100C, 100D, 100E, 100F, 100G
Support 10, 10E, 10F, 10G
First end 110, 110E, 110F, 110F, 110G
Second end 120, 120E, 120G
Connecting parts 11, 11E, 11G
First connection structure 111, 111E, 111G
Connector 20, 20C
Welding layer 201
First connecting piece 21C
Second connecting piece 22C
Adjustment parts 30, 30A, 30B, 30C, 30D
Radial Space 301, 301C
Enter channel 303
First channel 304
Second channel 305
First end 310
Second end 320
First closing end 31, 31A, 31B, 31C
Second closing end 32, 32A, 32B, 32C
Outer layer 33, 33A, 33B, 33C, 33D
Inner layer 34, 34A, 34B, 34C, 34D
First inner layer section 341A, 341B, 341C
Second inner layer segment 342A, 342B, 342C
Bending portions 343A, 343B
Flip layers 35, 35A, 35B, 35C, 35D
First flip section 351A, 351B, 351C
Second flip section 352A, 352B, 352C
Adaptation layer 36D
Clamp 50, 50E, 50F
Pivot 52, 614
Clamp arms 53, 53E, 53F
Flanged section 531
Anchor 532E
Arc structure 533E
Drive 61, 61E, 61F
Drive shaft 611, 611E, 611F
Connector 612, 612E, 612F
Connecting rod 613, 613E
Flexible drive arm 614F
Automatic closing unit 615E
Axial groove 617E
Grip 63, 63F
Gripping Arm 631, 631F
Capture unit 632, 632F
Fixed base 70
Locking mechanism 80
Locking element 81
Unlocking parts 82
Conveyor 200
Push Sheath 210
Second connection structure 211
Outer sheath 220
Splicing structure 300

The following specific implementation methods will further illustrate the present application in conjunction with the above-mentioned drawings.

Detailed ways

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

First of all, it should be noted that in the field of interventional medicine, along the delivery path of the instrument, the end of the instrument close to the operator is usually called the proximal end, and the end of the instrument away from the operator is called the distal end. Specifically, for a delivery device used to deliver an implantable device and release it into a patient's body, the distal end refers to the end of the delivery device that can be freely inserted into an animal or human body, and the proximal end refers to the end of the delivery device that is operated by a user or machine. Defined as axial, circumferential is the direction around the axis of a columnar object such as a cylinder or a tube (perpendicular to the axis and perpendicular to the cross-sectional radius), and radial refers to the direction along the diameter or radius. Among them, the axial, circumferential and radial directions together constitute the three orthogonal directions of the columnar object. It is worth noting that the "end" appearing in the terms "proximal end", "distal end", "one end", "the other end", "first end", "second end", "initial end", "end", "two ends", "free end", "upper end", "lower end", etc. is not limited to the end, endpoint or end face, but also includes a portion extending an axial distance and/or radial distance from the end, endpoint, or end face on the element to which the end, endpoint, or end face belongs. The above definitions are only for convenience of expression and are not to be construed as limitations on the present application.

It is to be understood that the terms in the specification and claims of the present application and the above-mentioned drawings are only for describing specific embodiments and are not intended to limit the present application. The terms "first", "second", etc. in the specification and claims of the present application and the above-mentioned drawings are used to distinguish different objects rather than to describe a specific order. Unless the context clearly states otherwise, the singular forms "one" and "said" are also intended to include plural forms. The term "including" and any variation thereof are intended to cover non-exclusive inclusions. In addition, the present application can be implemented in a variety of different forms and is not limited to the embodiments described in this embodiment. The purpose of providing the following specific embodiments is to facilitate a clearer and more thorough understanding of the disclosure of the present application, in which words indicating directions such as top, bottom, left, and right are only for the position of the structure shown in the corresponding drawings.

The following description is a preferred embodiment of the present invention, but the above description is for the purpose of explaining the general principles of the present invention and is not intended to limit the scope of the present invention. The scope of protection of the present invention shall be determined by the appended claims.

Embodiment 1

Referring to FIGS. 1 to 7 , the valve clamping device 100 with stable fitting provided in the first embodiment of the present application includes a support member 10, an adjusting member 30 and a clamping member 50. The adjusting member 30 is sleeved on the support member 10. The clamping member 50 is rotatably connected to the support member 10, and is arranged on the outside of the adjusting member 30 and can be opened or closed relative to the adjusting member 30. Among them, the adjusting member 30 is constructed as a three-dimensional structure with elasticity. The adjusting member 30 includes a first closing end 31, a second closing end 32, an outer layer 33, an inner layer 34 arranged between the outer layer 33 and the support member 10, and a flip layer 35. The first closing end 31 and the second closing end 32 are both sleeved on the outside of the support member 10. The flip layer 35 transitionally connects one end of the inner layer 34 and the outer layer 33. In this embodiment, the other end of the inner layer 34 is connected to the first closing end 31. In some other embodiments, the other end of the inner layer 34 can also be connected to the second closing section 32.

In this embodiment, the first closing end 31 and the second closing end 32 are fixedly arranged relative to the support member 10. It is understandable that in some other embodiments, the relative positions of the first closing end 31 and the second closing end 32 can be fixedly arranged (that is, the axial distance between the first closing end 31 and the second closing end 32 is a fixed value and the two cannot rotate relative to each other), and can move in a small range relative to the support member 10 along the axial direction of the support member 10. The so-called "small range movement" means that the axial movement distance of the first closing end 31 and the second closing end 32 is much smaller than the axial length of the support member 10. Specifically, the first closing end 31 and the second closing end 32 can synchronously move in the axial direction relative to the support member 10 in the range of 1mm-10mm, preferably in the range of 1mm-3mm, which meets the "small range movement" requirement.

Those skilled in the art should understand that FIG1 is merely an example of a stable fitting valve clamping device 100 and does not constitute a limitation of the stable fitting valve clamping device 100, and the stable fitting valve clamping device 100 may include more or fewer components than those shown in FIG1, or a combination of certain components, or different components. For example, the stable fitting valve clamping device 100 may also include a positioning developing part, etc.

For a clearer description, the two ends along the axial direction of the object are defined as the first end and the second end respectively; in Figures 1 to 31, when describing the first end or the second end of an object, the lower end of the object in the figure is the first end and the upper end is the second end. The support member 10 has a certain axial length and includes a first end 110 and a second end 120 that are arranged opposite to each other.

The support member 10 includes a connection portion 11 for detachably connecting to a delivery device. The connection portion 11 and the delivery device can be detachably connected together by means of a threaded connection, a snap connection, etc. Specifically, the connection portion 11 is releasably connected to the distal end of the delivery device. The operator pushes the valve clamping device 100 to the mitral valve of the patient, and then remotely operates the valve clamping device 100 to clamp the anterior and posterior leaflets of the mitral valve together. Once the leaflets of the mitral valve are aligned edge to edge, the operator The author can release the connection between the delivery device and the connecting part 11, so that the valve clipping device 100 is released and remains in the patient's body as an implant to keep the apposition positions of the valve leaflets together and alleviate the patient's mitral valve regurgitation.

In this embodiment, the connection part 11 is arranged on the second end 120 of the support member 10, wherein the first end 110 of the support member 10 is its distal end, and the second end 120 of the support member 10 is its proximal end. Specifically, the connection part 11 is provided with a first connection structure 111, and the delivery device is provided with a second connection structure that is fixed and detachably connected with the first connection structure 111, for example, the first connection structure 111 is a clamping hole, and the second connection structure is a clamping block; or, the first connection structure 111 is a clamping block, and the second connection structure is a clamping hole; or, the first connection structure 111 is a clamping block, and the second connection structure is a clamping hole; or, the first connection structure 111 and the second connection structure are both S-shaped buckle structures. When the first connection structure 111 is fixed with the second connection structure, the delivery device can deliver the valve clamping device 100, and when the first connection structure 111 is separated from the second connection structure, the delivery device is separated from the valve clamping device 100. It should be known that the structure of the support member 10 here is only used as an example, and is not a limitation of the present application. Other structures of the support member 10 adopted by ordinary technicians in this field based on the teachings of the present application are all within the protection scope of the present application.

The support member 10 is constructed as a hollow tubular structure to achieve linkage between the support member 10 and the conveying device. The tubular structure can be, but is not limited to, a circular tube, a square column tube, or an oblate tube, etc. In this embodiment, the support member 10 is a circular tube, as described above, the distal end of the circular tube is the first end 110, and the proximal end of the circular tube is the second end 120.

The adjusting member 30 includes a first end 310 and a second end 320 that are relatively arranged. In the present embodiment, the first end 310 of the adjusting member 30 is fixedly connected to the supporting member 10, and the second end 320 of the adjusting member 30 is located at the flip layer 35. The valve clamping device 100 with stable fitting has an expanded state and a closed state. The expanded state refers to a natural state in which the adjusting member 30 is not subjected to external force, that is, the adjusting member 30 is in a fully expanded working state. The closed state refers to a working state in which the adjusting member 30 is clamped by the clamping member 50, that is, the adjusting member 30 is in an incompletely expanded working state. In the closed state, the clamping member 50 can have a variety of forms with different clamping angles or different clamping forces. Optionally, the second end 120 of the support member 10 is located inside the adjusting member 30 both in the closed state and in the expanded state, that is, the second end 120 of the support member 10 may be surrounded and shielded by the partial flip layer 35 near the second end 320 of the adjusting member 30, so that it will not protrude from the adjusting member 30, thereby preventing the second end 120 of the support member 10 from directly contacting the leaflets, avoiding the second end 120 of the support member 10 from wearing the leaflets due to the long-term beating of the heart, and improving the safety of implantation.

The adjusting member 30 is a three-dimensional mesh structure made of shape memory material, so that under different clamping angles or different clamping forces of the clamping member 50, the adjusting member 30 can adapt to the gaps between different leaflets and undergo adaptive deformation, thereby adjusting the degree of pulling of the leaflets by the valve clamping device 100. Optionally, the adjusting member 30 is a three-dimensional mesh structure formed by weaving a braided wire with a shape memory function; or, a three-dimensional mesh structure is formed by cutting a rod or a tube with a shape memory function. Specifically, after the shape memory material is woven or cut, it is heat-treated and shaped so that the adjusting member 30 can have a specific shape. When the adjusting member 30 is subjected to external force, such as when it is squeezed by the clamping member 50, it can be deformed and tends to restore its original shape, thereby providing support for the clamping member 50. For example, for adjacent leaflets of the tricuspid valve with a large gap, thinness and fragility (which may be the anterior leaflet and posterior leaflet, the anterior leaflet and the septal leaflet, or the posterior leaflet and the septal leaflet of the tricuspid valve), the clamp 50 can be closed at a larger clamping angle to prevent the leaflets from being subjected to excessive stress and prevent the leaflets from being perforated or torn; for adjacent leaflets of the mitral valve (i.e., the anterior leaflet and the posterior leaflet of the mitral valve), the clamp 50 can be closed at a smaller clamping angle to provide a greater clamping force to the leaflets. Optionally, the three-dimensional mesh structure includes a plurality of grids formed by interweaving a plurality of braided wires, and the mesh shape of each grid is a polygon, for example, it may be but not limited to a quadrilateral. The braided wire may include one or more strands of silk thread. Multiple strands of silk thread are wound or braided side by side to form a braided wire. The radial dimension of the braided wire may be 0.06mm-0.20mm. The material of the braided wire is selected from biocompatible metal materials such as nickel-titanium alloy, stainless steel, cobalt-chromium alloy, etc., preferably nickel-titanium alloy.

Under the same degree of closure of the clamping member 50, the adjusting member 30 can adapt to the spacing between different leaflets and undergo adaptive deformation, thereby adjusting the degree of pulling of the leaflets by the valve clamping device 100 with stable fit. The porosity of the three-dimensional mesh structure is preferably in the range of 30% to 80%, so that the adjusting member 30 has both adaptive deformation capability and sufficient radial support strength. Optionally, the grid density of the inner layer 34 is greater than the grid density of the outer layer 33, so that the outer layer 33 of the adjusting member 30 can easily adapt to the spacing between different leaflets and undergo adaptive deformation, and the deformation capacity of the inner layer 34 of the adjusting member 30 is smaller than that of the outer layer 33. On the one hand, when the adjusting member 30 is not clamped by the clamping member 50, since the deformation capacity of the outer layer 33 is relatively large, the outer layer 33 can be quickly unfolded relative to the inner layer 34, thereby improving the surgical efficiency, and making the outer layer 33 have better flexibility and compliance to avoid the influence of heart movement on the leaflets; on the other hand, when clamped by the clamping member 50, since the deformation capacity of the inner layer 34 is relatively small, the inner layer 34 can axially pull the flip layer 35, and the flip layer 35 converts the axial pulling force of the inner layer 34 on itself into a supporting force on the outer layer 33 in the radial direction, thereby increasing the overall radial supporting force of the adjusting member 30 on the leaflets and improving the implantation stability of the valve clamping device 100.

The overall shape of the adjusting member 30 is approximately in the shape of an inverted cone. In the expanded state and the closed state, the diameter of the adjusting member 30 gradually increases from the first end 310 of the adjusting member 30 to the second end 320 of the adjusting member 30, wherein the first end 310 of the adjusting member 30 constitutes the apex of the inverted cone, and the portion near the second end 320 of the adjusting member 30 constitutes the bottom of the inverted cone. The adjusting member 30 forms an insertion channel 303 for the support member 10 to penetrate along the axial direction, and the second end 120 of the support member 10 is located in the insertion channel 303. Specifically, the insertion channel 303 includes a first channel 304 formed by the inner layer 34 and a second channel 305 formed by the partial inversion layer 35. The first channel 304 and the second channel 305 are connected, and the second end 120 of the support member 10 is located in the second channel 305. The first closing end 31, the second closing end 32, the inner layer 34, the outer layer 33 and the flip layer 35 together enclose a radial space 301, so that the inner layer 34, the outer layer 33 and the flip layer 35 of the adjusting member 30 can restrain each other and transmit and transform the force, thereby making the valve clamping device 100 fit the valve leaf more closely, and can also effectively improve the fatigue resistance of the adjusting member 30. Among them, the radial size of the opening at the first end of the penetration channel 303 is equal to or slightly larger than the radial size of the support member 10, and the radial size of the opening at the second end of the penetration channel 303 is larger than the radial size of the support member 10, thereby reserving sufficient space for the connection between the second connection structure of the conveying device (see 200 in FIG. 8 ) and the first connection structure 111 of the support member 10, so as to prevent the conveying device (see 200 in FIG. 8 ) from hooking the adjusting member 30.

As shown in Figures 2 to 5, it is worth noting that the turning layer 35 is constructed as a bending structure that turns inward from the edge of the outer layer 33 and extends to the inner layer 34. The outer shape of the axial cross section of the turning layer 35 is arc-shaped. In this way, when the clamp 50 is closed relative to the adjusting member 30 to clamp the leaflet between the adjusting member 30 and the clamp 50, the inner layer 34 will pull the flip layer 35 in the axial direction, and the flip layer 35 will convert the axial pulling force of the inner layer 34 on itself into a supporting force on the outer layer 33 in the radial direction. The inner layer 34 and the flip layer 35 work together to limit the axial lengthening of the adjusting member 30 when it is squeezed by the clamp 50, and limit the axial displacement of the flip layer 35. At the same time, the flip layer 35 and the inner layer 34 of the adjusting member 30 can form a shape with a concave middle and convex edges around, avoiding the problem in the prior art that the top of the elastomer is a tapered end and does not fit the valve sufficiently, so that the adjusting member 30 and the leaflet can fit stably and sufficiently, and the valve clamping device 100 can firmly clamp the leaflet, reduce the risk of the leaflet falling off from between the adjusting member 30 and the clamp 50, improve the implantation stability of the valve clamping device 100, and improve the surgical effect. In addition, the inner layer 34 and the flip layer 35 can wrap the connecting portion 11 of the support member 10 when the adjusting member 30 is compressed by the clamping member 50, thereby preventing the second end 120 of the support member 10 from causing damage to the leaflet, thereby improving the safety of the operation.

The valve clamping device 100 with stable fitting also includes a connector 20. The first closing end 31 and/or the second closing end 32 are connected to the support member 10 through the connector 20. The connector 20 is fixedly connected to the first closing end 31 and/or the second closing end 32, and is fixedly arranged relative to the support member 10. The fixed connection method of the first closing end 31 and/or the second closing end 32 and the support member 10 includes but is not limited to welding, bonding, crimping, fusion and the like. Optionally, the fixed connection method of the first closing end 31 and/or the second closing end 32 and the support member 10 is welding. In this embodiment, the first closing end 31 and the second closing end 32 are fixedly connected to the support member 10 through the same connector 20. In the case where the first closing end 31 and the second closing end 32 are both fixedly connected to the same connector 20, in some other embodiments, the connector 20 can move in a small range relative to the support member 10 along the axial direction of the support member 10 to drive the entire adjusting member 30 to move in a small range. The so-called "small range movement" means that the axial movement distance of the connecting member 20 is much smaller than the axial length of the supporting member 10. Specifically, the connecting member 20 can move relative to the supporting member 10. When the axial movement distance of the support member 10 is within the range of 1 mm-10 mm, preferably within the range of 1 mm-3 mm, it meets the "small range movement". Optionally, in some embodiments, the valve clamping device 100 with stable fitting further includes a limiting structure, which is used to limit the axial movement distance of the adjustment member 30 along the support member 10. The limiting structure can be provided on the support member 10.

In this embodiment, the first closed end 31 and the second closed end 32 are both fixedly connected to the support member 10 through the same connecting member 20. The first closed end 31 and the second closed end 32 are both sleeved on the outside of the support member 10. The first closed end 31 and the second closed end 32 are relatively close to the first end 110 of the support member 10. In some other embodiments, the first closed end 31 and the second closed end 32 are connected to the support member 10 through different connecting members 20.

The connector 20 is constructed as a cylindrical structure. In the present embodiment, the first closing end 31 and the second closing end 32 are both inserted into the inner cavity of the cylindrical structure from the same end of the cylindrical structure. Specifically, the first closing end 31 and the second closing end 32 are both inserted into the connector 20 from the upper end of the connector 20 and are fixedly connected to the connector 20. In some embodiments, the first closing end 31 and the second closing end 32 can be respectively inserted into the inner cavity of the cylindrical structure from the opposite ends of the cylindrical structure. Optionally, the connector 20 and the support member 10 are made of the same material, for example, both are stainless steel.

Optionally, the axial length of the outer layer 33 is equal to the axial length of the inner layer 34, so that the inner layer 34 provides a greater pulling force to the flip layer 35 in the axial direction, and the flip layer 35 can convert the pulling force into a supporting force for the outer layer 33 in the radial direction. The flip layer 35 converts the axial pulling force of the inner layer 34 on itself into a supporting force for the outer layer 33 in the radial direction. The inner layer 34 and the flip layer 35 work together to limit the axial lengthening of the adjusting member 30 when it is squeezed by the clamp 50, and limit the axial displacement of the flip layer 35. At the same time, the flip layer 35 and the inner layer 34 of the adjusting member 30 can form a shape with a concave middle and convex edges around, avoiding the problem in the prior art that the top of the elastomer is a tapered end and does not fit the valve sufficiently, so that the adjusting member 30 and the leaflet can fit stably and sufficiently, and the valve clamping device 100 can firmly clamp the leaflet, reduce the risk of the leaflet falling off from between the adjusting member 30 and the clamp 50, improve the implantation stability of the valve clamping device 100, and improve the surgical effect.

In this embodiment, the inner layer 34 is constructed as an integral structure. The inner layer 34 and the outer layer 33 each include a first end and a second end opposite to each other, the first end of the inner layer 34 is connected to the first closing end 31, the second end of the inner layer 34 is connected to the flip layer 35, the first end of the outer layer 33 is connected to the second closing end 32, and the second end of the outer layer 33 is connected to the flip layer 35.

The outer layer 33 is located radially outside the inner layer 34. The inner layer 34 is radially extended outward from its first end to its second end. The outer layer 33 is radially extended outward from its first end to its second end. The radial distance between the inner layer 34 and the outer layer 33 gradually increases from the first end of the outer layer 33 toward the second end of the outer layer 33. In this embodiment, the distance between the inner layer 34 and the central axis of the adjusting member 30 and the distance between the outer layer 33 and the central axis of the adjusting member 30 both gradually increase from the first end 310 of the adjusting member 30 toward the second end 320 of the adjusting member 30. The shapes of the inner layer 34 and the outer layer 33 are both bell-mouth-shaped, that is, the area enclosed by the inner layer 34 and the area enclosed by the outer layer 33 are bell-mouth-shaped. Therefore, when the adjusting member 30 is clamped by the clamping member 50, the outer contour of the adjusting member 30 changes closely to the change of the clamping angle of the clamping member 50, and the valve is more reliably fitted between the adjusting member 30 and the clamping member 50, thereby improving the implantation stability of the valve clamping device 100 and improving the surgical effect.

Optionally, in some embodiments, the outside of the adjusting member 30 is covered with a biocompatible film. In some other embodiments, the outside and inside of the adjusting member 30 are both covered with a biocompatible film. Optionally, the inside and/or outside of the outer layer 33 are covered with a biocompatible film. On the one hand, the film covering the adjusting member 30 can be used as a flow-blocking film to block the blood that flows back from the clamping gap, improve the reflux treatment effect, and prevent blood from entering the adjusting member 30 to form a thrombus; on the other hand, the film can make the valve clamping device 100 with stable fitting have stronger biocompatibility. The material of the film includes but is not limited to polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (EPTFE), polyester, silicone resin and other biocompatible polymers. In some embodiments, a drug coating can be provided on the film to reduce the probability of some inflammation and chronic diseases in the body caused by the film.

In this embodiment, the clamping member 50 is rotatably connected to the first end 110 of the support member 10, so that the clamping member 50 can be rotated around The adjusting member 30 is expanded or closed around the pivot 52 rotatably connected to the first end 110 of the supporting member 10. When the clamping member 50 is centered around the pivot 52 and closes around the adjusting member 30 to clamp the leaflet, the adjusting member 30 is clamped by the clamping member 50.

The clamping angle of the clamping member 50 can be designed according to factors such as the degree of mitral valve closure of the patient and/or the degree of deformation of the adjusting member 30. For example, as shown in FIG6, in the application scenario using the same adjusting member 30, when the degree of mitral valve regurgitation of the patient is severe, the clamping angle of the clamping member 50 clamping the adjusting member 30 is relatively small; as shown in FIG7, when the degree of mitral valve regurgitation of the patient is mild or moderate, the clamping angle of the clamping member 50 clamping the adjusting member 30 is relatively large. Thus, by controlling the clamping angle of the clamping member 50, it is ensured that the valve clamping device 100 can be used to clamp leaflets with different degrees of regurgitation, thereby improving the scope of application of the valve clamping device 100. In addition, when clamping two adjacent leaflets of the more fragile tricuspid valve, the clamping angle of the clamping member 50 clamping the adjusting member 30 can be controlled to be larger than when clamping the mitral valve.

Specifically, the clamping member 50 includes one or more clamp arm groups, each of which includes a plurality of clamp arms 53, such as two, three or more. In the present embodiment, the clamping member 50 includes one clamp arm group, and the clamp arm group includes two clamp arms 53 symmetrically arranged relative to the adjusting member 30. It is understandable that the clamp arm group and the number of clamp arms 53 in the clamp arm group are only used as examples, and are not specifically limited here. A person of ordinary skill in the art can select a suitable number of clamp arm groups, such as two or more clamp arm groups, as required. It is understandable that three or more clamp arms 53 can also be provided in each clamp arm group as required. For example, the anterior leaflet, the posterior leaflet and the septal leaflet of the tricuspid valve can be clamped simultaneously by three clamp arms 53 that can be opened and closed relatively, so as to treat tricuspid regurgitation; or, two of the anterior leaflet, the posterior leaflet and the septal leaflet of the tricuspid valve can be clamped by a pair of clamp arms 53, so as to achieve the purpose of alleviating or treating tricuspid regurgitation. It should be noted that the following will be described in detail by taking the clamping repair of two valve leaflets as an example. Specifically, the two leaflets may be the anterior leaflet and the posterior leaflet of the mitral valve, or the anterior leaflet and the posterior leaflet, the anterior leaflet and the septal leaflet, or the posterior leaflet and the septal leaflet of the tricuspid valve.

Optionally, each end of the clamp arm 53 is further provided with a flange section 531. The end of the clamp arm 53 refers to the end of the clamp arm 53 away from its rotation connection part, i.e., the pivot 52, or the free end of the clamp arm 53. The flange section 531 includes an arc surface that is turned toward the outside of the end of the clamp arm 53. Optionally, the radius of the arc surface is 1mm-2mm. When the clamp arm 53 is closed relative to the adjustment member 30 to clamp the valve leaflet therebetween, the valve leaflet and the arc surface of the flange section 531 are fitted, increasing the supporting area of the end of the clamp arm 53 for the valve leaflet, which can avoid the local force concentration of the valve leaflet at the end of the clamp arm 53, and effectively reduce the damage to the valve leaflet caused by repeated friction between the edge of the end of the clamp arm 53 and the valve leaflet as the heart beats. After the clamp arm 53 is abutted against the adjustment member 30, the flip layer 35 of the adjustment member 30 protrudes from the flange section 531 in the axial direction to ensure that the length of the valve leaflet clamped between the clamp arm 53 and the flip layer 35 is greater than the length of the clamp arm 53.

The atrioventricular valve clamping device 100 also includes a driving member 61 connected to the clamping member 50 to drive the clamping member 50 to expand or close relative to the adjusting member 30. Specifically, the driving member 61 is respectively connected to each clamp arm 53, for example, the driving member 61 is respectively connected to two clamp arms 53 in a group of clamp arms 53, to drive each clamp arm 53 to rotate around the adjusting member 30, so that the clamp arms 53 are close to or away from the adjusting member 30. In the delivery state, the driving member 61 drives the two clamp arms 53 to close around the adjusting member 30, thereby reducing the outer diameter of the valve clamping device 100 and facilitating delivery; after the valve clamping device 100 is deployed in the heart, the driving member 61 drives the clamp arms 53 to clamp the valve leaflets between the clamp arms 53 and the adjusting member 30, thereby achieving valve leaflet clamping.

In some embodiments, the valve clamping device 100 further includes a gripping member 63 that can be opened or closed relative to the adjusting member 30. The gripping member 63 is disposed between the clamping member 50 and the adjusting member 30. The gripping member 63 includes one or more gripping arm groups. Each gripping arm group includes a plurality of gripping arms 631, such as two, three or more than three. In this embodiment, the gripping member 63 includes a gripping arm group, and the gripping arm group includes two gripping arms 631 symmetrically disposed relative to the adjusting member 30. Optionally, the number of gripping arm groups corresponds to the number of clamp arm groups, and the number of gripping arms 631 of each gripping arm group corresponds to the number of clamp arms 53 of each clamp arm group, so that the gripping arms 631 cooperate with the clamp arms 53 to realize the leaflet capture function. A gripping unit 632 is disposed on one side of the gripping arm 631 facing the clamp arm 53. Among them, the gripping unit 632 is configured as a plurality of barbs disposed at intervals on the gripping arm 631, thereby improving the gripping ability of the gripping arm 631 to the leaflet. Optionally, the barbs are elastic.

In the delivery state, the gripping member 63 is at least partially accommodated on the inner surface of the clamping member 50. The gripping member 63 is at least partially embedded in the clamping member 50. Specifically, the clamp arm 53 is provided with a groove with a notch facing the adjusting member 30, and the gripping arm 631 is at least partially accommodated in the groove of the clamp arm 53, thereby reducing the outer diameter of the atrioventricular valve clamping device 100 and facilitating delivery. After the clamp arm 53 and the gripping arm 631 cooperate to capture the leaflet, the gripping arm 631 presses the leaflet into the groove of the clamp arm 53, which can increase the contact area between the clamp arm 53 and the leaflet and increase the clamping force on the leaflet.

The valve clamping device 100 also includes a fixed base 70 fixedly connected to the support member 10. The clamping member 50 is rotatably connected to the fixed base 70 via a pivot 52. Specifically, each clamp arm 53 is rotatably connected to the fixed base 70. The second end (i.e., the upper end) of the fixed base 70 is fixedly connected to the first end 110 of the support member 10. It should be noted that this part is defined as the term "fixed base 70" for the convenience of explanation. The structure that realizes the function of the fixed base 70 can also be the first end 110 of the support member 10 itself. Therefore, the definition of the term "fixed base 70" should not limit the scope of the present application. Each clamp arm 53 in each group is rotatably connected together on the fixed base 70 via a pivot 52. Under the drive of the driving member 61, each clamp arm 53 cooperates with each other to be able to unfold and close together around the adjusting member 30.

In this embodiment, the driving member 61 includes a driving shaft 611, a connecting seat 612 and two connecting rods 613. Among them, one end of each connecting rod 613 is rotatably connected to the clamping member 50, and the other end is rotatably connected to the connecting seat 612; one end of the driving shaft 611 is fixedly connected to the connecting seat 612, and the other end is movably installed in the fixed base 70. Specifically, one end of each connecting rod 613 is rotatably connected to the corresponding clamp arm 53, and the other end is rotatably connected to the connecting seat 612 through a pivot 614, that is, each clamp arm 53 is rotatably connected to the connecting seat 612 through the connecting rod 613 on the corresponding side. The driving shaft 611 movably passes through the fixed base 70. When the driving shaft 611 slides axially relative to the fixed base 70, it drives the connecting rod 613 to rotate and drives the clamp arm 53 to expand or close with the pivot 52 between it and the fixed base 70 as the center. In some embodiments, the fixed base 70 can be omitted, that is, the driving shaft 611 can also be directly and movably installed in the support member 10.

Specifically, when the drive shaft 611 moves axially relative to the fixed base 70 toward the first end 110 of the support member 10, the connecting rod 613 is driven to move. Under the pull of the connecting rod 613, the two clamp arms 53 rotate around the pivot 52 and open relatively. When the drive shaft 611 moves axially relative to the fixed base 70 toward the second end 120 of the support member 10, the connecting rod 613 pushes the clamp arms 53 to rotate around the pivot 52 so that the two clamp arms 53 are closed. The shape of the connecting seat 612 can be any structure such as a hemisphere, a spherical crown or a bullet shape, so that the valve clamping device 100 is easier to push in the body. The drive shaft 611 and the connecting seat 612 can be an integral structure or a non-integrated structure. In order to ensure safety after implantation, the drive shaft 611 and the connecting seat 612 are made of biocompatible materials such as polyester, silicone resin, stainless steel, cobalt alloy, cobalt-chromium alloy or titanium alloy, preferably stainless steel or cobalt-chromium alloy with higher hardness.

In some embodiments, the valve clamping device 100 further includes a locking mechanism 80 disposed in the fixed base 70. The locking mechanism 80 includes an unlocked state and a locked state. The locking mechanism 80 includes a locking member 81 and an unlocking member 82 that cooperates with the locking member 81. In the unlocked state, the locking member 81 is subjected to the pulling force from the conveying device on the unlocking member 82 to release the restriction on the relative movement of the drive shaft 611 and the fixed base 70. In the locked state, the locking member 81 is not subjected to the pulling force from the conveying device on the unlocking member 82. The locking member 81 locks the drive shaft 611 under the action of its own elastic force, that is, restricts the relative movement of the drive shaft 611 and the fixed base 70, and realizes the self-locking function. In the conveying state, the locking member 81 limits the relative movement between the drive shaft 611 and the fixed base 70, thereby ensuring that the clamping member 50 always remains in a closed state relative to the adjusting member 30 and the supporting member 10, thereby avoiding accidental expansion of the clamping member 50; after reaching the vicinity of the mitral valve, the conveying device 200 is controlled so that the tension of the unlocking member 82 acts on the locking member 81, that is, the unlocking member 82 unlocks the restriction of the locking member 81 on the drive shaft 611, thereby the clamping member 50 can be driven by the driving member 61 to expand and support the leaflets relative to the adjusting member 30 and the supporting member 10; after clamping the leaflets, the tension of the unlocking member 82 on the locking member 81 is cancelled, and the locking member 81 locks the drive shaft 611 under the action of its own elastic force and enters a locked state, at which time the locking member 81 again limits the relative movement of the drive shaft 611 and the fixed base 70, thereby maintaining the clamping state of the leaflets. In this embodiment, the locking member 81 includes an elastic steel sheet, and the unlocking member 82 includes an unlocking wire. It can be understood that It should be noted that, in other embodiments, any existing locking mechanism 80 with a suitable structure may be adopted, which will not be described in detail herein.

Please refer to Figures 8 to 12 , the present application also provides a valve clamping system 1000, including a valve clamping device 100 with stable fitting and a delivery device 200. The distal end of the delivery device 200 is detachably connected to the delivery device 200, and is used to deliver the valve clamping device 100 to the heart.

Please refer to Figures 8 to 12 together. The following uses the antegrade approach to and repair of the mitral valve through the left atrium (LA) as an example to illustrate the use of the valve clamping device 100 provided in the first embodiment.

Step 1: As shown in FIG8 , operate the delivery device 200 to push the drive shaft and the valve clamping device 100 connected thereto from the left atrium, through the mitral valve to the left ventricle (LV).

Step 2: Adjust the valve clamping device 100 to be close to the anterior leaflet and the posterior leaflet of the mitral valve.

Step 3: As shown in FIG. 9 , operate the unlocking member to unlock the locking member in the fixed base, drive the driving shaft through the conveying device 200 to drive the clamp arm 53 to open, and adjust the direction of the clamp arm 53 so that the clamp arm 53 is perpendicular to the apposition line of the mitral valve.

Step 4: As shown in FIG. 10 , the entire valve clamping device 100 is withdrawn proximally so that the forceps arm 53 holds the valve leaflet on the ventricular side.

Step 5: As shown in FIG. 10 , the grasping member 63 is released, and the grasping arm presses the valve leaflet on the atrial side. The anterior leaflet and the posterior leaflet of the mitral valve are clamped between a pair of forceps arms 53 and the grasping arm, respectively, thereby grasping the valve leaflet.

Step 6: As shown in FIG. 11 , when the anterior leaflet and the posterior leaflet of the mitral valve are captured between the pair of forceps arms 53 and the grasping arm, respectively, the driving shaft is pulled proximally through the delivery device 200, so that the driving shaft is withdrawn proximally, thereby driving the forceps arms 53 to close to clamp the valve leaflets;

Step 7: Release the connection between the valve clamping device 100 and the delivery device 200, then withdraw the delivery device from the body to obtain the implantation state shown in FIG. 12 . At this time, the valve clamping device 100 pulls the anterior leaflet and the posterior leaflet of the mitral valve toward each other to obtain a double-pore mitral valve, thereby completing the edge-to-edge repair of the mitral valve.

After the valve clamping device 100 is implanted, the elastic adjusting member 30 is filled between the anterior leaflet and the posterior leaflet of the clamped mitral valve and provides radial support force for the leaflet. The adjusting member 30 has a buffering effect on the beating leaflet, thereby achieving the adjustable degree of traction of the leaflet by the valve clamping device 100 to avoid damaging the leaflet.

Embodiment 2

Please refer to Figures 1 and 13-15 together. The valve clamping device 100A provided in the second embodiment of the present application has a similar structure to the valve clamping device 100 of the first embodiment. The difference is that the structure of the adjustment member 30A of the second embodiment is different from that of the first embodiment. It should be noted that the remaining structure of the valve clamping device 100 of the second embodiment is the same as that of the first embodiment, and will not be repeated here.

Specifically, in the second embodiment, the inner layer 34A includes a first inner layer segment 341A and a second inner layer segment 342A. The flip layer 35 includes a first flip segment 351A and a second flip segment 352A. As shown in Figures 14 and 15, the first flip segment 351A is above the dotted line a, and the second flip segment 352A is below the dotted line b. One end of the first inner layer segment 341A is connected to the first closing end 31A, and the other end is connected to the first flip segment 351A. One end of the second inner layer segment 342A is connected to the second closing end 32A, and the other end is connected to the second flip segment 352A, and the outer layer 33A is connected between the first flip segment 351A and the second flip segment 352A. Among them, the flip opening of the first flip segment 351A and the flip opening of the second flip segment 352A are arranged opposite to each other along the axial direction of the adjusting member 30A. Specifically, the cross-sections of the first flip segment 351A and the second flip segment 352A are both arc-shaped. In this embodiment, the maximum circumferential length of the first flip segment 351A is greater than the maximum circumferential length of the second flip segment 352A, wherein the second flip segment 352A is close to the pivot (see 52 in Figure 1), so that the adjusting member 30A as a whole can better conform to the shape when the clamping member 50 clamps the adjusting member 30A.

The first closing end 31A and the second closing end 32A are both inserted from the lower end of the connecting member 20 and fixedly connected to the connecting member 20. The first closing end 31A and the second closing end 32A can be fixed to the connecting member by bonding, welding, riveting, welding, etc. 20. Optionally, the first closing end 31A and the second closing end 32A form a circle of welding layer 201 at the upper end of the connector to improve the stability and reliability of the connection. The first inner layer segment 341A is connected to the second inner layer segment 342A through the connector 20. In this embodiment, a bending portion 343A is formed on the side of the first inner layer segment 341A close to the first closing end 31A, so that the radial distance between each part of the first inner layer segment 341A and the support member 10 does not change much. The shape of the radial cross-section of the bending portion 343A is an arc that is concave toward the first end 310 of the adjusting member 30A. The area enclosed by the first inner layer segment 341A is roughly in the shape of a straight cylinder; the area enclosed by the second inner layer segment 342A is roughly in the shape of a trumpet. The axial length of the inner layer is equal to the axial length of the outer layer 33A, so that the inner layer provides a greater pulling force to the flip layer 35A. In this embodiment, the connector 20 can be fixedly connected to the support member 10. In other embodiments, the connecting member 20 can also move relatively to the supporting member 10 in a small range along the axial direction of the supporting member 10. The two ends of the outer layer 33A are respectively connected to the first flip section 351A and the second flip section 352A. The outer layer 33A is located radially outward of the inner layer 34A, and the outer layer 33A extends radially outward relative to the supporting member 10 in the direction from the second flip section 352A to the first flip section 351A.

Please refer to Figure 16. When the clamping member 50 is closed relative to the adjusting member 30A to clamp the leaflet between the adjusting member 30A and the clamping member 50, the first inner layer segment 341A will pull the first flip segment 351A in the axial direction, and the first flip segment 351A will convert the axial pulling force of the first inner layer segment 341A on itself into a supporting force on the outer layer 33A in the radial direction; the second inner layer segment 342A will pull the second flip segment 352A in the axial direction, and the second flip segment 352A will convert the axial pulling force of the second inner layer segment 342A on itself into a supporting force on the outer layer 33A in the radial direction. The first inner layer segment 341A and the first flip segment The joint action of 351A and the second inner layer segment 342A and the second flip segment 352A can limit the axial lengthening of the adjusting member 30A when being squeezed by the clamping member 50, and limit the axial displacement of the first flip segment 351A and the second flip segment 352A. At the same time, a shape with a concave middle and convex edges can be formed between the first inner layer segment 341A and the first flip segment 351A of the adjusting member 30A, thereby avoiding the problem in the prior art that the top of the elastomer is a tapered end and does not fit the valve sufficiently, thereby enabling the adjusting member 30A to fit the leaflet stably and sufficiently, and the valve clamping device 100A can firmly clamp the leaflet.

Embodiment 3

Please refer to FIG. 1 and FIG. 17 together. The valve clamping device 100B provided in the third embodiment of the present application has a similar structure to the valve clamping device 100 of the first embodiment. The difference is that the structure of the adjustment member 30B of the third embodiment is different from that of the first embodiment. It should be noted that the remaining structure of the valve clamping device 100B of the third embodiment is the same as that of the first embodiment, and will not be repeated here.

Specifically, in the third embodiment, the inner layer 34B includes a first inner layer section 341B and a second inner layer section 342B. The flip layer 35B includes a first flip section 351B and a second flip section 352B. The first flip section 351B is located above the dotted line a, and the second flip section 352B is located below the dotted line b. One end of the first inner layer section 341B is connected to the first closing end 31B, and the other end is connected to the first flip section 351B. One end of the second inner layer section 342B is connected to the second closing end 32B, and the other end is connected to the second flip section 352B, and the outer layer 33B is connected between the first flip section 351B and the second flip section 352B. Among them, the flip opening of the first flip section 351B and the flip opening of the second flip section 352B are arranged opposite to each other along the axial direction of the adjusting member 30B. Specifically, the cross-sections of the first flip section 351B and the second flip section 352B are both arc-shaped. In this embodiment, the maximum circumferential length of the first flip segment 351B is greater than the maximum circumferential length of the second flip segment 352B, wherein the second flip segment 352B is close to one side of the pivot (see 52 in Figure 1) so that the adjusting member 30B as a whole can better conform to the shape when the clamping member clamps the adjusting member 30B.

The first closing end 31B and the second closing end 32B are both inserted from the upper end of the connecting member 20 and fixedly connected to the connecting member 20. In the present embodiment, a bending portion 343B is formed on one side of the second inner segment 342B close to the second closing end 32B, so that the radial distance between each part of the second inner segment 342B and the support member 10 does not change much. The shape of the radial cross-section of the bending portion 343B is an arc that is recessed toward the first end 310 of the adjusting member 30B. The shape of the outer layer 33B (the area enclosed by the outer layer 33B) is roughly bell-mouth-shaped. The shape of the first inner segment 341B (i.e., the area enclosed by the first inner segment 341B) is roughly bell-mouth-shaped; the shape of the second inner segment 342B (i.e., the area enclosed by the second inner segment 342B) is roughly straight-cylindrical. The conveying device is connected to the support When the second end 120 of the support member 10 is closed, the conveying device can smoothly enter the first inner layer section 341B in the shape of a bell mouth, and the adjusting member 30B will not hook the conveying device. Specifically, the outer diameter of the first inner layer section 341B gradually increases from the end relatively close to the second inner layer section 342B to the end relatively far away from the second inner layer section 342B. The axial length of the inner layer 34B is equal to the axial length of the outer layer 33B, so that the inner layer 34B provides sufficient pulling force to the flip layer 35B. The connecting member 20 can be fixedly connected to the support member (see 10 in Figure 1); or, it can be moved in a small range relative to the support member along the axial direction of the support member. The two ends of the outer layer 33B are respectively connected to the first flip section 351B and the second flip section 352B. The outer layer 33B is located radially outside the inner layer 34B, and the outer layer 33B extends radially outward relative to the support member 10 from the second flip section 352B to the first flip section 351B.

When the clamping member 50 is closed relative to the adjusting member 30B to clamp the leaflet between the adjusting member 30B and the clamping member 50, the first inner layer segment 341B will pull the first flip segment 351B in the axial direction, and the first flip segment 351B will convert the axial pulling force of the first inner layer segment 341B on itself into a supporting force for the outer layer 33B in the radial direction; the second inner layer segment 342B will pull the second flip segment 352B in the axial direction, and the second flip segment 352B will convert the axial pulling force of the second inner layer segment 342B on itself into a supporting force for the outer layer 33B in the radial direction. The second inner segment 342B and the second flip segment 352B work together to limit the axial lengthening of the adjusting member 30B when being squeezed by the clamping member 50, and limit the axial displacement of the first flip segment 351B and the second flip segment 352B. At the same time, a shape with a concave middle and convex edges can be formed between the first inner segment 341B and the first flip segment 351B of the adjusting member 30B, thereby avoiding the problem in the prior art that the top of the elastomer is a tapered end and does not fit the valve sufficiently, thereby ensuring that the adjusting member 30B and the leaflet fit stably and sufficiently, and the valve clamping device 100B can firmly clamp the leaflet.

Embodiment 4

Please refer to FIG. 1 and FIG. 18 together. The valve clamping device 100C provided in the fourth embodiment of the present application has a similar structure to the valve clamping device 100 of the first embodiment. The difference is that the structure of the adjusting member 30C of the fourth embodiment is different from that of the first embodiment. It should be noted that the remaining structure of the valve clamping device 100C of the fourth embodiment is the same as that of the first embodiment, and will not be repeated here.

Specifically, in the fourth embodiment, the inner layer 34C includes a first inner layer section 341C and a second inner layer section 342C. The flip layer 35C includes a first flip section 351C and a second flip section 352C. The first flip section 351C is located above the dotted line a, and the second flip section 352C is located below the dotted line b. One end of the first inner layer section 341C is connected to the first closing end 31C, and the other end is connected to the first flip section 351C. One end of the second inner layer section 342C is connected to the second closing end 32C, and the other end is connected to the second flip section 352C, and the outer layer 33C is connected between the first flip section 351C and the second flip section 352C. Among them, the flip opening of the first flip section 351C and the flip opening of the second flip section 352C are arranged opposite to each other along the axial direction of the adjusting member 30C. Specifically, the cross-sections of the first flip section 351C and the second flip section 352C are both arc-shaped, that is, the flip opening of the first flip section 351C and the flip opening of the second flip section 352C are arc-shaped. The maximum circumferential length of the first flip section 351C is greater than the maximum circumferential length of the second flip section 352C, and is complementary in shape to the clamping member 50 , making it easier for the clamping member 50 to clamp the adjusting member 30C.

The shape of the outer layer 33C (the area enclosed by the outer layer 33C) is roughly bell-shaped. The shape of the first inner layer segment 341C and the shape of the second inner layer segment 342C are roughly bell-shaped or bowl-shaped. Optionally, the shape of the first inner layer segment 341C (i.e., the area enclosed by the first inner layer segment 341C) is roughly bowl-shaped, and the shape of the second inner layer segment 342C (the area enclosed by the second inner layer segment 342C) is roughly bell-shaped.

The first closing end 31C and the second closing end 32C are connected to the support member 10 through different connecting members 20C. Specifically, the connecting member 20C includes a first connecting member 21C connected to the first closing end 31C and a second connecting member 22C connected to the second closing end 32C. The first closing end 31C is inserted from the upper end of the first connecting member 21C and fixedly connected to the first connecting member 21C, and the second closing end 32C is inserted from the lower end of the second connecting member 22C and fixedly connected to the second connecting member 22C. Both the first connecting member 21C and the second connecting member 22C are fixedly connected to the support member 10; or, the first connecting member 21C and the second connecting member 22C It can synchronously move in a small range along the axial direction relative to the support member 10. The fixed connection method between the first connecting member 21C and the first closing end 31C, the fixed connection method between the second connecting member 22C and the second closing end 32C, and the fixed connection method between the first connecting member 21C, the second connecting member 22C and the support member 10 include but are not limited to welding, bonding, crimping, melting and the like. The axial length of the inner layer 34C is less than the axial length of the outer layer 33C, and the support member 10 and the first closing end 31C, the second closing end 32C, the inner layer 34C, the outer layer 33C and the flip section together enclose a radial space 301C. The outer layer 33C extends radially inward from top to bottom toward the support member 10, and the outer layer 33C is located radially outside the inner layer 34C.

Embodiment 5

Please refer to FIG. 1 and FIG. 19 to FIG. 20 together. The valve clamping device 100D provided in the fifth embodiment of the present application is similar in structure to the valve clamping device 100A of the second embodiment. The difference is that the structure of the adjustment member 30D of the fifth embodiment is different from that of the second embodiment. It should be noted that the remaining structure of the valve clamping device 100D of the fifth embodiment is the same as that of the second embodiment, and will not be repeated here.

Specifically, the adjusting member 30D further includes an adapting layer 36D. The adapting layer 36D is connected between the flip layer 35D and the outer layer 33D. The free end of the clamp 50 is provided with a flanging section 531, and the shape of the flanging section 531 is complementary to the shape of the adapting layer 36D. When the clamp arm 53 is closed relative to the adjusting member 30D to clamp the leaflet therebetween, part of the leaflet is also clamped between the adapting layer 36D and the flanging section 531. In this embodiment, the adapting layer 36D protrudes from the flanging section 531 in the axial direction, or the adapting layer 36D is higher than the flanging section 531. Thus, on the one hand, the leaflet is fitted with the arc surface of the flange section 531 and the arc surface of the adapting layer 36D, increasing the supporting area of the end of the clamp arm 53 for the leaflet, which can avoid the local force concentration of the leaflet at the end of the clamp arm 53, and effectively reduce the damage to the leaflet caused by repeated friction between the edge of the end of the clamp arm 53 and the leaflet as the heart beats; on the other hand, the leaflet is also fitted with the arc-shaped adapting layer 36D, further increasing the fitting area of the leaflet and the adjusting member 30D, improving the elastic fitting of the leaflet and the adjusting member 30D, and making the leaflet and the adjusting member 30D fit more fully. The structure of the inner layer 34D is the same as that of the inner layer 32A of the second embodiment, and will not be repeated here.

When the clamp arm 53 is closed relative to the adjusting member 30D, the adjusting member 30D is approximately mushroom-shaped. The adapting layer 36D is smoothly and fixedly connected with the flip layer 35D and the outer layer 33D to reduce the damage of the adjusting member 30D to the valve leaflet and ensure that the adapting layer 36D is fully fitted with the valve leaflet.

Embodiment 6

Please refer to FIG. 13 and FIG. 21 to FIG. 23 together. The valve clamping device 100E provided in the sixth embodiment of the present application is similar in structure to the valve clamping device 100A in the second embodiment. The difference is that the structure of the clamping member 50E in the sixth embodiment is different from that in the second embodiment. It should be noted that the remaining structure of the valve clamping device 100E in the sixth embodiment is the same as that in the second embodiment, and will not be repeated here.

In the sixth embodiment, the valve clamping device 100E omits the gripping member 63 of the valve clamping device 100A of the second embodiment, thereby simplifying the overall structure of the valve clamping device. The clamping member 50E of the valve clamping device 100E includes a group of clamp arms 53E. Each clamp arm 53E is provided with an anchoring portion 532E on the side facing the adjusting member 30A, so as to prevent the leaflet from slipping off the clamp arm 53E after being clamped by the clamping member 50E, thereby ensuring the stability of the valve clamping device 100 clamping the leaflet. When the clamp arm 53E is closed relative to the adjusting member 30A, the anchoring portion 532E can abut against the leaflet to embed it in the mesh of the adjusting member of the mesh structure, so as to fix the leaflet tissue through the anchoring portion 532E on the basis of the adjusting member and the clamp arm 53E clamping the leaflet. Among them, the anchoring portion 532E is constructed as a sharp tooth structure.

The driving member 61E includes a driving shaft 611E, an automatic closing unit 615E and at least two connecting rods 613E. One end of each connecting rod 613E is rotatably connected to a corresponding clamp arm 53E, and the other end is directly rotatably connected to the driving shaft 611E through a pin. The driving shaft 611E is movably installed in the support member 10E. The automatic closing unit 615E connects the two clamp arms 53E to enable The clamping member 50E abuts against the adjusting member 30A in the closed state.

The connecting seat 612E and the first end 110E of the support member 10E are an integral structure. The two clamp arms 53E are rotatably connected to the connecting seat 612E. An axial groove 617E for the pin to pass through is provided on the support member 10. When the driving shaft 611E drives the pin to move in the axial groove 617E toward the first end 110E of the support member 10, the connecting rod 613E is driven to overcome the obstruction of the automatic closing unit 615E and the two clamp arms 53E are relatively opened.

In this embodiment, the automatic closing unit 615E is a U-shaped spring sheet, and the two ends of the U-shaped spring sheet are respectively connected to a clamp arm 53E. When the driving shaft 611E does not apply thrust to the pin shaft, the U-shaped spring sheet uses its own reset to drive the two clamp arms 53E to close and abut against the adjustment member. It can be understood that in other embodiments, the automatic closing unit 615E can also be an elastic member such as a V-shaped spring sheet or a torsion spring. The clamping force of the automatic closing unit 615E comes from the elastic force of the spring sheet or the torsion spring.

In this embodiment, a connecting portion 11E detachably connected to the delivery device is provided on the second end 120E of the support member 10. Specifically, the connecting portion 11E and the delivery device can be connected via a threaded structure. An arc-shaped structure 533E is provided at the free end of the clamp arm 53E, thereby preventing the valve leaflet from being subjected to local force concentration at the end of the clamp arm 53E, and effectively reducing the damage to the valve leaflet caused by repeated friction between the end edge of the clamp arm 53E and the valve leaflet as the heart beats.

It should be noted that the adjusting member in the sixth embodiment can be replaced by the adjusting member in the first embodiment, the third embodiment or the fourth embodiment, which will not be described in detail here.

Embodiment 7

Please refer to FIG. 1 , FIG. 24 and FIG. 25 . The valve clamping device 100F provided in the seventh embodiment of the present application is similar in structure to the valve clamping device 100 of the first embodiment. The difference is that the structure of the clamping member 50F and the driving member 61F of the seventh embodiment is different from that of the first embodiment. It should be noted that the remaining structure of the valve clamping device 100F of the seventh embodiment is the same as that of the first embodiment, and will not be repeated here.

In this embodiment, the proximal end of the clamping member 50F is connected to the support member 10F, and the distal end of the clamping member 50F is connected to the drive shaft 611F. Specifically, the connecting seat 612F and the first end 110F of the support member 10F are an integral structure. One end of the clamp arm 53F of the clamping member 50F is connected to the connecting seat 612F. The drive member 61F includes a drive shaft 611F and at least two elastic drive arms 614F. One end of the elastic drive arm 614F is fixedly connected to one end of the drive shaft 611F, and the other end of the elastic drive arm 614F is connected to one end of the clamp arm 53F away from the connecting seat 612F. One end of the drive shaft 611F away from the elastic drive arm 614F is movably installed in the support member 10F. The elastic drive arm 614F is used to make the clamping member 50F close to the adjusting member 30 in a natural state.

One end of the gripping arm 631F is connected to the clamp arm 53F. A plurality of gripping units 632F are arranged at intervals at the end of the gripping arm 631F.

In this embodiment, the two clamp arms 53F and the two elastic drive arms 614F are an integrated structure, that is, the two clamp arms 53F themselves are also elastic. When the drive shaft 611F moves toward the first end 110F of the support member 10F, the two clamp arms 53F are relatively opened by overcoming the obstruction of the two elastic drive arms 614F. When the drive shaft 611F does not apply a thrust to the elastic drive arms 614F, the two elastic drive arms 614F use their own reset to drive the two clamp arms 53F to close and abut against the adjustment member 30. It is worth noting that when the drive shaft 611F continues to push toward the first end 110F of the support member 10F, the connection between the clamp arms 53F and the elastic drive arms 614F can gradually approach the drive shaft 611F until the clamp arms 53F and the elastic drive arms 614F are basically in a straight line, and then the pull wire is used to control the grasping arm 631F to abut against the adjustment member 30. In this state, it is easier to put the entire flattened valve clamping device 100F into the push sheath.

In addition, the valve clamping device 100F in the seventh embodiment can achieve a dynamic balance of the clamping state of the valve leaflets during the process of clamping and releasing the valve leaflets. Specifically, when the valve leaflets exert a large pulling force on the valve clamping device 100F, the elastic drive arm 614F and the clamp arm 53F can adjust the clamping angle within a certain range without separating from the valve leaflets, thereby preventing the valve leaflets from being damaged by excessive pulling force. Since the adjustment member 30 has a certain radial support force, and the clamp arm 53F can adaptively adjust the angle, the adjustment member 30 can adjust the clamping angle of the valve leaflets to a certain extent. During the process, the adjusting member 30 can always elastically fit the leaflet to ensure the clamping effect and prevent the leaflet from falling off.

It should be noted that the adjustment member 30 in the seventh embodiment can be replaced by the adjustment members 30A, 30B, 30C in the second, third or fourth embodiments, which will not be described in detail here.

Embodiment 8

Please refer to FIG. 1 and FIG. 26 together. The valve clamping device 100G of the valve clamping system 2000 provided in the eighth embodiment of the present application is similar in structure to the valve clamping device 100 of the first embodiment. The difference is that the structure of the support member 10G of the eighth embodiment is different from that of the first embodiment. It should be noted that the remaining structure of the valve clamping device 100G of the eighth embodiment is the same as that of the first embodiment, and will not be repeated here.

In the eighth embodiment, a valve clipping system 2000 with stable fitting includes a valve clipping device 100G and a delivery device 200. The delivery device 200 can deliver the valve clipping device 100G from outside the body to the vicinity of the mitral valve and clip the valve leaflets. The delivery device 200 includes a push sheath 210 and a core shaft movably installed in the push sheath 210. The push sheath 210 is detachably connected to the support member 10G, and the core shaft of the push sheath 210 is used to drive the expansion and closure of the clip 50.

The connecting portion 11G of the support member 10G is arranged at the first end 110G of the support member 10G (i.e., the proximal end of the valve clamping device 100G). The second end 120G of the support member 10G is the distal end of the valve clamping device 100. The push sheath 210 has a certain axial length. The connecting portion 11G is detachably connected to the push sheath 210 of the conveying device 200. The connecting portion 11G and the push sheath 210 of the conveying device 200 are respectively provided with a splicing structure 300 of complementary shape. Specifically, the splicing structure 300 includes a first connecting structure 111G arranged on the connecting portion 11G and a second connecting structure 211 arranged on the push sheath 210 and fixedly and detachably connected to the first connecting structure 111G, thereby realizing a detachable connection between the support member 10G and the conveying device 200. In the present embodiment, the first connecting structure 111G and the second connecting structure 211 are constructed as an S-shaped buckle structure of complementary shape.

The outer sheath 220 is movably sleeved outside the push sheath 210. When the outer sheath 220 surrounds the complementary splicing structure 300, the support 10G and the conveying device 200 remain connected, and when the outer sheath 220 is withdrawn and the complementary splicing structure 300 is exposed, the support 10G and the conveying device 200 can be disconnected.

Please refer to FIGS. 26 to 31 . The valve clipping system 2000 in this embodiment is suitable for repairing the mitral valve via the apical approach. The specific use process is as follows:

Step 1: As shown in FIG. 27 , the delivery device 200 is operated to push the push sheath 210 and the valve clamping device 100 connected thereto from the apex to the left ventricle and approach the mitral valve.

Step 2: As shown in FIG. 28 , operate the unlocking member to unlock the locking member in the fixed base, push the core shaft of the delivery device 200 distally to drive the clamp arm 53 to open relative to the fixed base and support the leaflet.

Step 3: As shown in FIG. 29 , the gripping member 63 is released, and the gripping member 63 presses the valve leaflet on the atrial side, and the anterior leaflet and the posterior leaflet of the mitral valve are clamped between the pair of forceps arms 53 and the gripping member 63, respectively, thereby gripping the valve leaflet;

Step 4: As shown in FIG. 30 , when the anterior leaflet and the posterior leaflet of the mitral valve are captured between a pair of forceps arms 53 and the gripping member 63 , respectively, the core shaft is pulled proximally to drive the forceps arms 53 to close so as to clamp the leaflets.

Step 5: As shown in FIG. 31 , release the valve clamping device 100G and withdraw the delivery device 200 from the body.

It should be noted that before the two clamp arms 53 are completely closed, the outer sheath 220 should remain wrapped around the complementary splicing structure 300. After the two clamp arms 53 are completely closed, the connection between the core shaft of the push sheath 210 and the drive shaft 611 is first released, and the push sheath 210 is withdrawn to release the connection between the valve clipping device 100G and the delivery device 200.

It can be understood that the valve clamping device and valve clamping system provided in the present application can also perform edge-to-edge repair of the tricuspid valve, as long as the corresponding intervention pathway (such as femoral vein-inferior vena cava-right atrium-right ventricle) is selected and an appropriate number of valve clamping devices are implanted as needed.

The above describes the embodiments of the present application in detail. In this paper, specific examples are used to illustrate the principles and implementation methods of the present application. The above embodiments are described only to help understand the method and core idea of the present application. At the same time, for those skilled in the art, according to the idea of the present application, there will be changes in the specific implementation method and application scope. In summary, the content of this specification should not be understood as limiting the present application.

Claims

A valve clamping device with stable fitting, characterized by comprising:

supporting item;

an adjusting member, wherein the adjusting member is sleeved on the supporting member; and

A clamping member, the clamping member is rotatably connected to the supporting member, and is disposed outside the adjusting member and can be opened or closed relative to the adjusting member;

The adjusting member is constructed as a three-dimensional structure with elasticity, and the adjusting member includes a first closing end, a second closing end, an outer layer, an inner layer and a flip layer arranged between the outer layer and the support member; the first closing end and the second closing end are both sleeved on the outer side of the support member, the flip layer transitionally connects one end of the inner layer and the outer layer, and the other end of the inner layer is connected to at least one of the first closing end and the second closing end;

The first closing end and the second closing end are fixedly arranged relative to the support member; or, the first closing end and the second closing end are fixed in relative position and can move within a small range relative to the support member along the axial direction of the support member.
The stably fitting valve clamping device according to claim 1 is characterized in that the flip layer is constructed as a bending structure that flips inward from the edge of the outer layer and extends to the inner layer.
The stably fitting valve clamping device according to claim 2 is characterized in that the axial cross-section of the turnover layer is arc-shaped.
The stable fitting valve clamping device according to claim 1 is characterized in that the axial length of the outer layer is equal to the axial length of the inner layer.
The stable fitting valve clamping device according to claim 1 is characterized in that the adjusting member is a three-dimensional mesh structure made of shape memory material, and the mesh density of the inner layer is greater than the mesh density of the outer layer.
The stably fitting valve clamping device according to claim 1 is characterized in that it also includes a connecting member, and the first closing end and/or the second closing end is connected to the supporting member through the connecting member.
The stably fitting valve clamping device according to claim 6 is characterized in that the connecting member is fixedly connected to the first closing end and/or the second closing end, and is fixedly arranged relative to the support member; or, the connecting member can move within a small range relative to the support member along the axial direction of the support member.
The stably fitting valve clamping device according to claim 7 is characterized in that the first closing end and the second closing end are connected to the support member through the same connecting member; or, the first closing end and the second closing end are connected to the support member through different connecting members.
The stable fitting valve clamping device according to claim 8 is characterized in that the connecting piece is constructed as a tubular structure, and the first closed end and the second closed end are both inserted into the inner cavity of the tubular structure from the same end of the tubular structure; or, the first closed end and the second closed end are respectively inserted into the inner cavity of the tubular structure from opposite ends of the tubular structure.
The stable fitting valve clamping device according to claim 6 is characterized in that the inner layer includes a first inner layer segment and a second inner layer segment, and the first inner layer segment is connected to the second inner layer segment through the connecting piece.
The stably fitting valve clamping device according to claim 10 is characterized in that a bending portion is formed on a side of the first inner layer segment close to the first closing end and/or a bending portion is formed on a side of the second inner layer segment close to the second closing end.
The stable fitting valve clamping device according to claim 1 is characterized in that the first closing end, the second closing end, the inner layer, the outer layer and the flip layer together enclose a radial space.
The stable fitting valve clamping device according to claim 1 is characterized in that the inner layer is constructed as an integral The structure comprises an inner layer and an outer layer each comprising a first end and a second end opposite to each other, the first end of the inner layer being connected to the first closing end, the second end of the inner layer being connected to the flip layer, the first end of the outer layer being connected to the second closing end, and the second end of the outer layer being connected to the flip layer.
The stable fitting valve clamping device according to claim 13 is characterized in that the inner layer extends radially outward from the first end of the inner layer to the second end of the inner layer, and the outer layer extends radially outward from the first end of the outer layer to the second end of the outer layer, and the radial distance between the inner layer and the outer layer gradually increases from the first end of the outer layer toward the second end of the outer layer.
The stable fitting valve clamping device according to claim 1 is characterized in that the inner layer includes a first inner layer segment and a second inner layer segment, the flip layer includes a first flip segment and a second flip segment, one end of the first inner layer segment is connected to the first closing end, and the other end is connected to the first flip segment, one end of the second inner layer segment is connected to the second closing end, and the other end is connected to the second flip segment, and the outer layer is connected between the first flip segment and the second flip segment.
The stably fitting valve clamping device according to claim 15 is characterized in that the flipping mouth of the first flip segment and the flipping mouth of the second flip segment are arranged opposite to each other along the axial direction of the adjusting member, and the maximum circumferential length of the first flip segment is greater than the maximum circumferential length of the second flip segment.
The stably fitting valve clamping device according to any one of claims 1-16 is characterized in that the adjusting member also includes an adapting layer, the adapting layer is connected between the flip layer and the outer layer, and the free end of the clamping member is provided with a flanging section, and the shape of the flanging section is complementary to the shape of the adapting layer.
A valve clamping system, characterized in that it comprises a delivery device and a stably fitting valve clamping device as described in any one of claims 1 to 17, wherein the distal end of the delivery device is detachably connected to the stably fitting valve clamping device.