CN114271993B

CN114271993B - Valve repair device

Info

Publication number: CN114271993B
Application number: CN202111561629.XA
Authority: CN
Inventors: 吴明明; 耿肖肖; 陈大凯
Original assignee: Koka Nantong Lifesciences Co Ltd
Current assignee: Koka Nantong Lifesciences Co Ltd
Priority date: 2021-11-10
Filing date: 2021-12-20
Publication date: 2025-08-15
Anticipated expiration: 2041-12-20
Also published as: CN216417423U; CN216417422U; CN216417421U; CN117045398A; CN114271993A

Abstract

The present application discloses a valve repair device, comprising: a spacer element, an inner clamping assembly, a clip assembly, an outer clamping element, an outer frame assembly, and a covering material. The valve repair device of the present application adopts components with different stiffness designs to achieve smaller operating force when clamping, which is beneficial to the doctor's precision control during operation; the present application adopts an integrally formed U-shaped outer clamping element, and utilizes the stiffness design of its outer clamping arm to continuously maintain the opposite clamping force on each component/element in the clamping space, and the structurally simpler clamping method has a more stable clamping effect compared to the related technology that relies on the frame/strip to provide elastic clamping force, and has a simpler preparation process compared to the outer and inner clamping arms formed by folding metal braided materials in the prior art.

Description

Valve repair device

Technical Field

The application relates to the field of medical equipment, in particular to a valve repair device which is beneficial to repairing a natural heart valve.

Background

In the cardiovascular system, natural heart valves (e.g., aortic, pulmonary, mitral, and tricuspid valves) play a critical role in ensuring a positive flow of adequate supply of blood. But these heart valves may be damaged by congenital malformations, inflammatory processes, infectious conditions, or diseases, such as degenerative processes (e.g., barlow disease or fiber deficiency, etc.), inflammatory processes (e.g., rheumatic heart disease, etc.), and infectious processes (e.g., endocarditis, etc.), to reduce their effectiveness. In addition, damage to the left or right ventricle from a pre-heart attack (i.e., myocardial infarction secondary to coronary artery disease) or other heart disease (e.g., cardiomyopathy, etc.) can distort the geometry of the native valve, which can cause the native valve to malfunction. Most patients undergoing valve surgery, such as mitral valve surgery, suffer from degenerative diseases that result in leaflet dysfunction of the native valve (e.g., mitral valve), causing prolapse and regurgitation.

For example, mitral regurgitation may be caused by a number of different mechanical defects of the mitral valve or left ventricle wall. The leaflets, the chordae clathrae connecting the leaflets to the papillary muscles, or the papillary muscles themselves or the left ventricle wall may be damaged or otherwise dysfunctional. In general, the annulus may be damaged, dilated or weakened, thereby limiting the ability of the mitral valve to close sufficiently against the large pressure of the left ventricle, which can lead to serious cardiovascular damage or death.

For many years, definitive treatment for such damaged valves has been surgical repair or replacement of the valve in open heart surgery. However, open heart surgery is highly invasive and is prone to many complications. As a result, older and weaker patients with defective heart valves are often untreated. Recently, transvascular techniques have been developed for introducing and implanting prosthetic devices in a manner that is much less invasive than open heart surgery. One particular transvascular technique for accessing the native mitral and aortic valves is the transseptal technique. The transseptal technique involves inserting a catheter into the right femoral vein, up the inferior vena cava and into the right atrium, then puncturing the septum and threading the catheter into the left atrium.

However, in the case of the interval technique implantation treatment technique, the prosthetic device such as the clamp usually adopts a very complex mechanical structure to achieve the capturing and clamping of the natural valve, which puts high operation demands on doctors in the operation process, often because the mechanical structure of the clamp is too complex to cause operation failure in the process of opening or turning the clamp, etc., after the clamp clamps the natural valve, the mechanical locking mode is needed to keep the part of the natural valve closed, but a plurality of clinical experiments show that the mechanical structure is locked/locked to generate the risk that the clamp is separated from the natural valve along with long-time heart contraction.

Disclosure of Invention

In view of the above-mentioned drawbacks of the related art, an object of the present application is to provide a valve repair device for solving the problem of inconvenience in operation caused by the complicated mechanical structure design of the clamp and the problem of risk of detachment caused by the mechanical locking/locking manner in the related art.

To achieve the above and other related objects, the present application discloses a valve repair device comprising a spacer element comprising a spacer body having a first stiffness, a proximal end of the spacer body being provided with a connecting portion for connecting a delivery device, opposite sides of a distal end of the spacer body being provided with first hinge portions, respectively; the inner clamping assembly comprises a first inner clamping arm and a second inner clamping arm which respectively have second rigidity, the proximal ends of the first inner clamping arm and the second inner clamping arm are respectively hinged to the first hinging portion, the distal ends of the first inner clamping arm and the second inner clamping arm are respectively provided with the second hinging portion, the clamping piece assembly is arranged on the inner clamping assembly or hinged to the first hinging portion and comprises a first clamping piece which can be opened or closed relative to the first inner clamping arm and a second clamping piece which can be opened or closed relative to the second inner clamping arm, the distal ends of the first clamping piece and the second clamping piece are respectively provided with a traction portion, the outer clamping element comprises a distal end portion and a first outer clamping arm and a second outer clamping arm which are integrally formed with the distal end portion, the proximal ends of the first outer clamping arm and the second outer clamping arm are respectively hinged to the second hinging portion, the first outer clamping arm and the second outer clamping arm respectively have third rigidity, the first outer clamping arm and the second clamping arm are opened or closed relative to the second inner clamping arm, the second clamping arm and the second clamping arm are separated from the inner clamping arm and the outer clamping arm, and the clamping element are kept in a clamping space, and the clamping space between the clamping assembly and the outer clamping assembly is kept.

In summary, the valve repairing device provided by the application adopts two hinge structures to hinge the spacing element and the inner clamping component at the first place, and hinges the inner clamping component and the outer clamping component with a U-shaped structure at the second place, wherein the two hinge structures have better flexibility effect compared with the prior art by adopting only one hinge structure and adopting a folding structure at the other place, the valve repairing device requires smaller force when the driving shaft drives the spacing element to move towards the distal end of the outer clamping component, thereby being beneficial to the precision control of doctors in operation, and furthermore, the valve repairing device adopts an integrally formed U-shaped outer clamping component, and the rigidity design of the outer clamping arm continuously maintains opposite clamping force for each component/component in the clamping space, so that the clamping effect is ensured by adopting mechanical locking in comparison with the prior art.

Drawings

The specific features of the application related to the application are shown in the appended claims. A better understanding of the features and advantages of the application in accordance with the present application will be obtained by reference to the exemplary embodiments and the accompanying drawings that are described in detail below. The drawings are briefly described as follows:

Fig. 1 is a schematic diagram of a conveying apparatus according to an embodiment of the present application.

Fig. 2 is a schematic view of a valve repair device of the present application in an extended state in one embodiment.

Fig. 3 is a schematic view of a valve repair device of the present application in an open state in one embodiment.

Fig. 4 is a schematic view of a valve repair device of the present application in an embodiment in a closed state.

Fig. 5 shows an exploded view of the intermediate element in an embodiment of the application.

Fig. 6 is a schematic view showing the combined structure of the intermediate members in one embodiment of the present application.

Fig. 7 shows a schematic structural view of an intermediate element according to another embodiment of the present application.

Fig. 8 shows a side view of the intermediate element of an embodiment of the application in two directions.

Fig. 9 shows a schematic structural view of an intermediate element in a further embodiment of the application.

Fig. 10 is a schematic view illustrating an assembly of an inner clip assembly according to an embodiment of the present application.

FIG. 11 is a schematic view showing the structure of the first or second inner clip arms according to an embodiment of the present application.

Fig. 12 is a schematic view of a valve repair device of the present application in another embodiment in an expanded state.

Fig. 13 is a schematic view showing the engagement of barbs and puncture holes on the clip and inner clip arms according to an embodiment of the present application.

Figure 14 is a schematic view of the expansion and closing of the clip assembly in one embodiment of the present application.

Fig. 15 is a schematic view showing the structure of a clip according to another embodiment of the present application.

FIG. 16 is an exploded view of the assembly of the clip and the inner clip arm according to one embodiment of the present application.

FIG. 17 is a schematic view showing an assembled structure of the clip and the inner clip arm according to an embodiment of the application.

Figure 18 shows a schematic view of the barb configuration on a clip according to another embodiment of the present application.

Fig. 19 is a schematic view showing a state in which the outer clip member is held in an embodiment of the present application.

Fig. 20 is a schematic structural view of an external clamping member according to an embodiment of the present application.

Fig. 21 is a schematic view showing the structure of a valve repair device according to another embodiment of the present application.

Fig. 22 shows a side view of an external gripping element in an embodiment of the application.

Fig. 23 shows a side view of an external gripping element according to another embodiment of the application.

Fig. 24 shows a side view of an external gripping element according to a further embodiment of the application.

Fig. 25 is a schematic view showing the cooperation of the outer clip member with the drive shaft in one embodiment of the present application.

Fig. 26 is a schematic view showing the structure of the external clamping member in still another embodiment of the present application.

Fig. 27 is a schematic view showing the configuration of the frame assembly in the valve repair device according to an embodiment of the application.

Fig. 28 is a schematic view showing an outer frame structure of an outer frame assembly according to an embodiment of the application.

Fig. 29 is a schematic view showing a closed state in which the valve repair device of the present application is covered with a covering material in one embodiment.

FIG. 30 is a schematic view showing an open state of the valve repair device of the present application covered with covering material in one embodiment.

Fig. 31 is a schematic view showing an open state in which the valve repair device of the present application is covered with a covering material in another embodiment.

Detailed Description

Further advantages and effects of the present application will become apparent to those skilled in the art from the disclosure of the present application, which is described by the following specific examples.

In the following description, reference is made to the accompanying drawings which describe several embodiments of the application. It is to be understood that other embodiments may be utilized and that mechanical, structural, electrical, and operational changes may be made without departing from the spirit and scope of the present disclosure. The following detailed description is not to be taken in a limiting sense, and the scope of embodiments of the present application is defined only by the claims of the issued patent. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. Spatially relative terms, such as "upper," "lower," "left," "right," "lower," "upper," and the like, may be used herein to facilitate a description of one element or feature as illustrated in the figures as being related to another element or feature.

Although the terms first, second, etc. may be used herein to describe various elements or parameters in some examples, these elements or parameters should not be limited by these terms. These terms are only used to distinguish one element or parameter from another element or parameter. For example, the first inner clamp arm may be referred to as a second inner clamp arm, and similarly, the second inner clamp arm may be referred to as a first inner clamp arm, without departing from the scope of the various described embodiments. The first and second inner arms are each described as one inner arm, but they are not the same unless the context clearly indicates otherwise. Similar situations also include the first clip and the second clip, or the first outer clip arm and the second outer clip arm.

Furthermore, as used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context indicates otherwise. It will be further understood that the terms "comprises," "comprising," "includes," and/or "including" specify the presence of stated features, steps, operations, elements, components, items, categories, and/or groups, but do not preclude the presence, presence or addition of one or more other features, steps, operations, elements, components, items, categories, and/or groups. The terms "or" and/or "as used herein are to be construed as inclusive, or meaning any one or any combination. Thus, "A, B or C" or "A, B and/or C" means "any of A, B, C, A and B, A and C, B and C, A, B and C". An exception to this definition will occur only when a combination of elements, functions, steps or operations are in some way inherently mutually exclusive.

During operation, the left atrium receives oxygenated blood from the lungs, and during diastole or diastole, through expansion of the left ventricle, blood previously collected in the left atrium moves through the mitral valve and into the left ventricle during systole. During the systolic phase or systole, the left ventricle contracts to force blood into the body through the aortic valve and ascending aorta. During systole, the leaflets of the mitral valve close to prevent backflow of blood from the left ventricle and back into the left atrium, and blood collects in the left atrium from the pulmonary veins. In one example embodiment, the valve repair device of the present application is used to repair the function of a defective mitral valve. That is, the valve repair device is configured to facilitate closing of leaflets of the mitral valve to prevent backflow of blood from the left ventricle and back into the left atrium. In another example embodiment, a valve repair device of the present application is used to repair the function of a defective tricuspid valve.

In the present application, the valve repair device may assume a plurality of states, such as an extended state, an open state, and a closed state, in an actual procedure application, the valve repair device is implanted through a delivery catheter/delivery sheath of a delivery device, the delivery sheath of the delivery device is inserted into the left atrium through the septum, and the valve repair device protrudes from the delivery sheath to assume an extended state, and is partially opened to assume an umbrella shape when the valve repair device is delivered into the mitral valve at a position where it enters the left ventricle, at which time the valve repair device is fully closed after capturing the native leaflet to achieve its clamping on the native mitral valve by operating the jaws on the inner clamp arms on both sides thereof.

In the present application, when describing the valve repair device, "proximal" refers to the side of the delivery device or the side in the direction of the user-manipulated end when the valve repair device assumes an expanded state, and correspondingly, "distal" refers to the side of the valve repair device that is distal from the delivery device or the side in the direction of the user-manipulated end when the valve repair device assumes an expanded state.

In the present application, the spatial terms "outer side" or "outward" refer to the reference direction of the central axis of the valve repair device, which is the radial direction of the central axis, in the reference direction of the central axis, where the radial direction of the central axis is the "outward", for example, two surfaces of the first or second spacer plates, one surface facing the gap between the first and second spacer plates, is defined as the inner surface, the back of the inner surface is defined as the outer surface, and correspondingly, in the present application, a clamping space is formed between two outer clamping arms of the outer clamping element, the opposite surfaces of the two outer clamping arms on both sides of the clamping space are defined as the inner surfaces, and the back of the inner surface of each of the outer clamping arms is defined as the outer surface.

In the present application, the spatial term "first direction" refers to a width direction of a clamping space between two outer clamping arms of an outer clamping element or a width direction of a gap between a first and a second spacing plate of a spacing element, and the spatial term "second direction" refers to a direction perpendicular to the first direction, which is sometimes referred to herein as a transverse direction, and the second direction is sometimes referred to herein as a longitudinal direction, and for convenience of space description, may also refer to a third direction, which is a direction perpendicular to the first and second directions, and the first direction is sometimes referred to as a vertical direction, for example, a direction in which the spacing element moves when driven by a driving shaft is referred to as a vertical movement or an up-down movement.

In the present application, the spatial term "proximate" refers to a location that is near or proximate to a component, it being understood that "proximate" is defined to be at least proximate (and includes) to a given location or state.

In the present application, when one or more elements or components are described as being connected, joined, fixed, journaled, hinged, coupled, attached or otherwise interconnected, such interconnection may be directly between the components or may be indirect, such as through the use of one or more intervening components. Moreover, references to "an assembly," "a component," "a member" or "a portion" as described herein should not be limited to a single structural component, member, or element, but may include an assembly of components, members, or elements. Moreover, as described herein, the terms "substantially" and "about" are defined as at least approaching (and including) a given value or state (preferably within 10%, more preferably within 1%, and most preferably within 0.1%).

In the present application, the term "hinge structure" refers to a structure that connects two parts by means of hinge, and in a specific application, the hinge structure may be a shaft hole structure that mates with a shaft hole, a shaft that mates with a shaft hole, or a pivoting structure, and the hinge structure may be formed by folding or curling a sheet.

In the present application, the term "rigidity" refers to the ability of a structure to resist elastic deformation when subjected to a force, where the "rigidity" is used to characterize the difficulty of deformation of the structure or the external force required by deformation of the structure, for example, the rigidity of a spacer refers to the external force required by deformation of the spacer, the rigidity of an inner clip refers to the external force required by deformation of the inner clip, the rigidity of an outer clip refers to the external force required by deformation of the outer clip, and it should be understood that the rigidity of the outer clip is smaller than the rigidity of the inner clip, and that the force applied to the outer clip when the outer clip is deformed cannot deform the outer clip. The stiffness of the whole of the spacer element refers to the ability of the whole of the spacer element to resist elastic deformation when subjected to a force.

In the present application, the term "integrally formed" refers to a structure that is integrally formed as one piece by a machining process such as stamping, cutting, pouring, casting, etc., and is not separable.

The valve repair device of the present application is implanted via a delivery catheter/delivery sheath of a delivery device that is inserted into the left atrium through the septum and that extends from the delivery catheter/delivery sheath and is brought to an extended state by controlling a drive shaft extending from the delivery catheter/delivery sheath, when the valve repair device is delivered into the mitral valve into the left ventricle to be partially opened to assume an umbrella shape, at which time the valve repair device is fully closed after capturing the native valve by operating the jaws on the inner clip arms on both sides thereof to capture the native valve leaflet to achieve its clamping onto the native valve, and then disengaged from the valve repair device by operating the drive shaft of the delivery device, i.e., by operating the release structure on the distal end of the delivery catheter/delivery sheath, pulling away the drive shaft to release the engagement of the connection on the spacer element and pulling the pull wire away from the pull hole of the clip assembly, thus holding the valve repair device onto the native valve, thereby completing the partial clamping of the native valve.

Referring to fig. 1, a schematic structure of a delivery device according to an embodiment of the present application is shown, in which, in this embodiment, the delivery device 2 may sequentially include a release mechanism 21, a delivery mechanism 22, an adjustable bending mechanism 23, a loader mechanism 24 and an outer sheath mechanism 25 from a proximal end to a distal end, the delivery mechanism 22 is detachably connected to the valve repair device, and the delivery mechanism 22 is used for delivering the valve repair device to a target location. The delivery mechanism 22 includes a delivery tube 220 and a delivery handle 221. The delivery tube 220 may extend through and out of the adjustable bend 230. The delivery handle 221 includes a delivery housing and a pull wire control assembly 222. The distal end of the delivery housing is connected to the proximal end of the delivery tube 220, and a delivery end cap is removably disposed at the distal end of the delivery housing. The pull wire control assembly 222 can slide on the conveying shell along the axial direction of the conveying pipe, the pull wire control assembly 222 is connected with the clamping piece assembly of the valve repair device, the pull wire control assembly 222 controls the opening and closing of the clamping piece assembly when sliding along the axial direction, and the number of the knobs of the pull wire control assembly 222 is the same as the number of the clamping pieces in the clamping piece assembly, so that one knob can control the opening and closing of one clamping piece. In this embodiment, the delivery device 2 is used in combination with a valve repair device, and when in use, the delivery pull wire (traction wire) of the delivery structure 22 is detachably connected with a clip in the clip assembly of the valve repair device, and the drive shaft 20 (central core rod) of the release structure 22 is detachably connected with the valve repair device. In some embodiments, the valve repair device may also be referred to as a transfemoral valve repair clip.

In one example embodiment of the application, the valve repair device includes a spacer element, an inner clip assembly, a clip assembly, and an outer clip assembly, and in another example embodiment of the application, the valve repair device includes a spacer element, an inner clip assembly, a clip assembly, an outer frame assembly, and a covering material.

The valve repair device can be converted into a plurality of states such as an extended state, an open state and a closed state in an actual operation application link, referring to fig. 2 to 4, fig. 2 is a schematic view of the valve repair device in an extended state in an embodiment, fig. 3 is a schematic view of the valve repair device in an open state in an embodiment, fig. 4 is a schematic view of the valve repair device in an embodiment, and the valve repair device 1 comprises a spacing element 11, an inner clip assembly 12, a clip assembly 13, an outer clip element 14 and an outer frame assembly 15.

In the state shown in fig. 2, the valve repair device 1 is in an expanded state, and the outer frame assembly and the covering material are not shown in fig. 2 for the convenience of exhibiting the internal structure. The extended state refers to a state in which the spacing element 11 is most distant from the distal end 143 of the outer clip element 14, and when the valve repair device 1 is in the extended state, the components in the valve repair device 1 are the spacing element 11, the inner clip component 12 (when the clip component 13 is fixed on the inner clip component 12), and the outer clip element 14 in this order from the proximal end to the distal end, in which the first hinge portion 113 is located at a position closer to the proximal end than the second hinge portion 123, and in which the spacing element 11, the inner clip component 12, and the clip component 13 are all folded to be clamped in the clamping space of the outer clip element 14 when the valve repair device 1 is in the closed state, in which the second hinge portion 123 is located at a position closer to the proximal end than the first hinge portion 113.

Passing through an open state during the transition of the valve repair device 1 from the unfolded state to the closed state, the process is that the spacing element 11 moves towards the distal end 143 of the outer frame assembly 14, the inner clip assembly 12 with larger rigidity is forced to move to two sides due to the movable connection of the spacing element 11 by the first hinge part 113, the inner clip assembly 12 with larger rigidity is forced to move to two sides due to the linear movement of the spacing element 11, and the outer clip assembly 14 with smaller rigidity is deformed by the inner clip assembly 12 by the movable connection of the second hinge part 123, so that the valve repair device 1 is in an inverted umbrella-like structure as shown in fig. 3 as a whole; the spacer element 11 is driven by external force to move towards the distal end 143 of the outer clip element 14, when the outer clip element 14 with smaller rigidity is spread to the greatest extent by the inner clip element 12, the first hinge part 113 and the second hinge part 123 are almost at the same height, the distal end of the spacer element 11 connected by the first hinge part 113 and the proximal end of the inner clip element 12 approach to the distal end 143 of the outer clip element 14 due to the linear movement of the spacer element 11 towards the distal end 143 of the outer clip element 14, the inner clip element 12 is folded to move the proximal end towards the distal end 143 of the outer clip element 14, the inner clip element 12 is forced to abut the two sides of the spacer element 11 by the elastic restoring force of the two sides of the outer clip element 14, and the valve repair device 1 is in a closed state as shown in fig. 4.

The spacer element is configured to be positioned within the orifice of the native valve to help fill the space and form a more effective seal, thereby reducing or preventing regurgitation as described above. The spacer element may have a structure that is impermeable to blood and allows the native leaflets to close around the spacer element during ventricular systole to prevent blood from flowing from the left or right ventricle back to the left or right atrium, respectively. The spacer element is sometimes referred to as a "connection structure" in the inventor's previously filed patent application because its proximal end is for connection to an external delivery device and its distal end is for connection to the inner clamping assembly. In the present application, the spacer element may fill the space between the abnormally operated native mitral or tricuspid leaflets that are not fully closed.

The spacer body of the spacer element has a first stiffness, i.e. the overall stiffness of the spacer element is defined as the first stiffness, and in practice the spacer element is moved by the force output by the drive shaft 20 of the delivery device, and the spacer element itself is not deformed due to the design of its overall first stiffness when the drive shaft 20 drives the spacer element in relation to the distal end of the grip element.

Referring to fig. 5 and 6, fig. 5 is a schematic exploded view of the spacer element according to the present application in one embodiment, fig. 6 is a schematic assembled view of the spacer element according to the present application in one embodiment, and as shown in the drawings, the proximal end of the spacer body 110 of the spacer element 11 has a connecting portion 111 for connecting to a conveying device, and opposite sides of the distal end thereof have first hinge portions respectively, and in one exemplary embodiment, the spacer element 11 includes a connecting head 112, a neck 114, first and second spacer plates 115 and 116 separated from the neck and extending distally, and hinge structures 1131 and 1132 formed at the distal ends of the first and second spacer plates 115 and 116, respectively, and the connecting head 112, the neck 114, the first and second spacer plates 115 and 116, and the hinge structures 1131 and 1132 are integrally formed.

Referring back to fig. 4, in the embodiment shown in fig. 4, in the state that the spacer element 11, the clip assembly 13, and the inner clip assembly 12 are located in the clamping space, the connector of the spacer element 11 is higher than the clip assembly 13 or the inner clip assembly 12 or the outer clip element 14, so that the conveying device is not interfered by any component of the clip assembly 13, the inner clip assembly 12, and the outer clip element 14 when the spacer element 11 is released.

In one embodiment, the valve repair device is implanted through a delivery catheter/delivery sheath of the delivery device, the delivery sheath of the delivery device is inserted into the left atrium through the septum, and the valve repair device is extended from the delivery sheath to assume an extended state, and when the valve repair device is delivered into the mitral valve and enters the left ventricle to assume a partially opened position to assume a shape resembling an inverted umbrella, the valve repair device is fully closed to achieve clamping of the valve repair device on the native mitral valve after the native valve is captured by operating the jaws on the inner arms on both sides thereof, and when the valve repair device is confirmed to have completed clamping of the native mitral valve, the valve repair device needs to be detached from the delivery sheath, and a release structure is provided on the delivery sheath and detachably connected with the valve repair device, wherein the release structure comprises a drive shaft 20 (or called a middle mandrel), a release control end, and a prosthetic control assembly, and wherein the distal end of the middle mandrel is detachably connected with the valve repair device after passing through the delivery tube, and the distal end of the middle mandrel is in a threaded connection with the valve repair device. The proximal end of the middle core rod is provided with a release control end, and the middle core rod is connected with or separated from the valve repair device through the release control end. Preferably, the release control end may be a release knob, where the release knob is fixed to the end of the proximal end of the central core rod, and the central core rod is driven to rotate by rotating the release knob, so as to realize detachable connection or separation with the valve repair device, so as to avoid interference or blockage of the release structure during operation, the connector of the spacer element is higher than the clip assembly or the inner clip assembly or the outer clip element, and the connecting portion provided on the connector is also higher than the clip assembly or the inner clip assembly or the outer clip element, so that the release structure is prevented from touching any one of the clip assembly or the inner clip assembly or the outer clip element during the manipulation.

In the embodiment shown in fig. 5 and 6, the connecting head 112 of the spacer element 11 is fixed with the connecting portion 111, two opposite sides of the connecting portion 111 are respectively provided with an ear-shaped clamping block 1111 for clamping the conveying device, and the connecting portion 111 and the connecting head 112 are provided with a through hole 117 for passing through the driving shaft 20 of the conveying device.

In some embodiments, the ear-shaped latch 1111 may also be referred to as a connecting ear. The connection portion 111 may also be referred to as a top seat, and the connection head 112 may be referred to as a connection member. The first or second spacer plate 115, 116 may also be referred to as a web.

In the embodiment shown in fig. 5 and 6, the connecting portion 111 is fixedly connected to the connecting head 112 by an interference fit, two opposite sides of the connecting portion 111 are respectively provided with an ear-shaped clamping block 1111 for clamping the release structure in the conveying device, and the ear-shaped clamping block 1111 is detachably connected to the external conveying device, and accordingly, the release structure (not shown) of the conveying device includes two clamping blocks with clamping holes corresponding to the ear-shaped clamping block 1111, the clamping blocks have elasticity and are limited on the middle core rod in a penetrating manner, after the middle core rod is pulled away, the clamping blocks on two sides are opened to two sides due to the elasticity of the clamping blocks, and the purpose of separating the clamping holes from the ear-shaped clamping blocks on the clamping blocks is achieved.

Referring to fig. 7, which is a schematic view of the structure of the spacer element according to another embodiment of the present application, the height H of the connector portion 111 of the spacer element 11 may be set by increasing the length of the neck portion 114 of the spacer element 11 in the exemplary embodiment of fig. 7.

In an embodiment, each side of the connecting portion 111 of the spacing element 11 is provided with an ear-shaped clamping block 1111, and correspondingly, the releasing structure of the conveying device is provided with four clamping blocks corresponding to each ear-shaped clamping block 1111, so that the valve repairing device can be ensured to be arranged on the delivery sheath of the conveying device in a firmer manner, or in another embodiment, the releasing structure of the conveying device is still provided with two clamping blocks corresponding to the ear-shaped clamping blocks 1111 and provided with clamping holes, so that after the releasing structure of the conveying device releases the valve repairing device, when the valve repairing device needs to be captured at this time, the success rate of capturing the connecting portion 111 of the spacing element 11 by the two clamping blocks of the releasing structure is increased, and the capturing of the ear-shaped clamping blocks 1111 on any two opposite sides can achieve the capturing of the connecting portion.

In the embodiment shown in fig. 5 and 6, the extending directions of the ear-shaped clamping blocks 1111 at the two sides of the connecting portion 111 of the spacing element 11 are parallel to the plate surfaces of the first spacing plate 115 and the second spacing plate 116, so as to ensure that the outer clamping arms at the two sides of the outer clamping element, the inner clamping arms at the two sides of the inner clamping assembly and the two clamping pieces of the clamping piece assembly are not at the same side as the ear-shaped clamping blocks 1111 at the two sides of the connecting portion when the valve repairing device is in a closed state, and further, the clamping pieces can be effectively prevented from being interfered or blocked when being released to open towards the two sides.

The connecting portion 111 and the connecting head 112 of the spacer element 11 are provided with through holes 117 for the passage of the drive shaft 20 of the delivery device, for the passage of the drive shaft 20 of the delivery device through the spacer element 11 up to the coupling to the distal end of the outer clamping element, respectively, with a gap between the distal ends of the first 115 and second 116 spacer plates of the spacer element 11 for the passage of the drive shaft 20 of the delivery device. In another embodiment, when the distal ends of the first and second partition plates of the partition member are of a mutually coupled structure, a through hole through which the driving shaft 20 of the transporting device passes is formed at the coupling.

In one embodiment, the neck 114 of the spacer element 11 includes a bridge structure 1141 separating the first and second spacer plates 115, 116. The bridge structure 1141 includes an arc surface formed on the inner wall of the joint to separate the first partition plate 115 and the second partition plate 116 by a predetermined distance. In this embodiment, the bridge structure 1141 forms a sealed end having a thickness greater than the thickness of the other portions (the first and second partition plates 115 and 116). In this embodiment, the seal end length is not less than 1/4 of the overall length of the first or second spacer plates 115, 116. To avoid two ear-like clips 1111 (connecting ears) on the same side as the inner clip assembly and clip assembly from blocking their withdrawal after clamping the native/native leaflets, the sealing end is designed to be longer in length, thereby increasing the distance of the ear-like clips 1111 from the inner clip assembly and clip assembly.

In the present embodiment, the neck 114 is a reinforced structure, specifically, the bridge structure 1141 separating the first and second partition plates 115 and 116 is designed to strengthen the rigidity of the neck 114 by being thicker than the thickness of the first and second partition plates 115 and 116, and the first and second partition plates 115 and 116 extend from the bridge structure 1141 to the distal end and start to separate to form two sheets with gaps.

Referring to fig. 8, which is a side view of the middle spacer element of an embodiment of the present application in two directions, the width W1 of the bridge 1141 in the first direction is larger than the maximum separation width W2 of the first spacer 115 and the second spacer 116, the width W3 of the bridge 1141 in the second direction is smaller than the maximum width W4 of the first spacer 115 or the second spacer 116, as shown in fig. 8 (a) and (b), in this embodiment, the first direction is defined as the transverse direction, the second direction is defined as the longitudinal direction, the width W1 of the bridge 1141 in the transverse direction is larger than the maximum separation width W2 of the first spacer 115 and the second spacer 116, and the width W3 of the bridge 1141 is smaller than the maximum width W4 of either the first spacer 115 or the second spacer 116, so that a concave element is formed at the transition portion of the neck and the first spacer 115 and the second spacer 116, but the stiffness of the sealing element is not clamped between the middle spacer element and the middle spacer element is reduced, and the sealing element is not clamped between the middle spacer element and the middle spacer element, and the middle spacer element is completely closed, and the middle spacer element is prevented from sealing the middle of the middle spacer element.

In one embodiment, the spacing element separates the first and second spacing plates 115 and 116 via the bridge structure 1141, and the plate surface gap between the first and second spacing plates 115 and 116 decreases from the bridge structure 1141 toward the distal ends of the first and second spacing plates 115 and 116, i.e., the plate surface gap adjacent to the bridge structure 1141 is larger than the plate surface gap at the distal ends of the first and second spacing plates 115 and 116, as shown in fig. 8 (a). In this embodiment, the distal face gap of the first and second spacer plates 115, 116 is greater than or equal to the diameter of the drive shaft 20 of the delivery device so that the drive shaft 20 passes through the spacer element to the distal end of the outer clip element.

In some embodiments, the first partition plate 115 or the second partition plate 116 may have a semicircular cross section, that is, the inner surface of the first partition plate 115 opposite to the second partition plate 116 is a plane, and the outer surface is a cambered surface, or other cross-sectional shapes that are beneficial to the involution function.

In an embodiment, the hinge structure of the first or second partition plate facing the distal end of the first or second partition plate is in a decreasing width structure, in this embodiment, the plate body of the first or second partition plate is not in a uniform width design, and the plate body adopts a structure decreasing in width from the proximal end to the distal end, specifically, please refer to fig. 9, which shows a schematic structural view of a middle partition element in another embodiment of the present application, after the plate body of the first partition plate 115 is separated from the bridge structure 1141, one side edge (e.g. defined as a first side 1150) of the plate body extends to a certain length, so that the plate body width of the first partition plate is gradually narrowed until the hinge part to the distal end, and accordingly, after the plate body of the second partition plate 116 is separated from the bridge structure 1141, the plate body extends to a side edge (e.g. defined as a second side 1160) of the plate body begins to be contracted inwards, so that the plate body width of the first partition plate body is gradually narrowed until the hinge part to the distal end, so designed, and a narrower hinge part is obtained, or a narrower hinge part is obtained, and when the inner partition plate 115 is further opened, the inner partition arm is further, the inner partition plate 11 is further more easily connected to the outer partition plate is further, and the inner partition plate 11 is further, so that the inner partition plate is more easily opened, and the hinge member is further, and the inner partition element is further, compared with the inner partition element is further, and the inner partition element is further required to be further opened, and the inner partition element is further, and the hinge element is further required is further easily opened.

According to the above description, a portion of the first side edge of the first partition plate 115 extends in a shrinking trend, and a portion of the second side edge of the second partition plate 116 extends in a shrinking trend, so that the hinge structure formed on the first partition plate 115 and the hinge structure formed on the second partition plate 116 are offset from each other, and further, the stress balance of the first hinge portion is ensured.

In the embodiment shown in fig. 8, the spacer body of the spacer element has a first hinge portion 113 on opposite sides of the distal end thereof, and in the embodiment, the maximum width W5 of the first hinge portion 113 of the first spacer plate 115 and the first hinge portion of the second spacer plate 116 in the first direction is not greater than the maximum width W6 of the connecting portion 111 of the spacer element 11 in the first direction. In this embodiment, the hinge structure formed by the distal end of the first partition plate 115 or the second partition plate 116 is an outwardly curled hinge structure, and in this embodiment, the maximum width W5 of the hinge structure of the first partition plate 115 and the hinge structure of the second partition plate 116 in the first direction is not greater than the maximum width W6 of the connecting portion 111 of the partition element 11 in the first direction, so that the width of the entire proximal end and the distal end of the partition element is limited so as to facilitate not occupying a larger radial space when in the delivery catheter of the delivery device in which the valve repair device is limited.

In the embodiment shown in fig. 8 (a), the hinge structure is curled outwards in a direction away from the gap between the first partition plate 115 and the second partition plate 116, so that the axis point of the first hinge part falls outside the main body of the partition element, which is further beneficial to hinge the inner clip assembly, and when the inner clip assembly is hinged on the first hinge part, the hinge structures curled outwards at two sides of the first partition plate 115 and the second partition plate 116 have a certain distance, so that the first inner clip arm and the second inner clip arm of the inner clip assembly do not interfere with each other when rotating.

In the embodiment shown in fig. 5, fig. 6 or fig. 8 (b), the plate bodies of the first partition plate 115 and the second partition plate 116 of the spacer element are plate bodies with uniform width, and the distal end of the first partition plate 115 or the second partition plate 116 forms a hinge structure with two separated and outwardly curled hinge structures, so that the proximal end of the inner clamping arm of the inner clamping assembly is hinged between the two separated and outwardly curled hinge structures, thereby forming a hinge with stable pivoting, and ensuring the stress balance of the hinge point.

In the embodiment shown in fig. 9, the plate bodies of the first partition plate 115 and the second partition plate 116 of the spacer element are plate bodies with uneven widths, a portion of the first side edge of the first partition plate 115 extends in a shrinking trend, and a portion of the second side edge of the second partition plate 116 extends in a shrinking trend, so that the hinge structures formed on the first partition plate 115 and the hinge structures formed on the second partition plate 116 are offset from each other, so as to ensure the stress balance of the hinge points on both sides of the spacer element.

In the present application, the inner clip assembly is hinged to the distal end of the spacer element by means of hinge, please refer to fig. 10, which shows an assembly schematic diagram of the inner clip assembly according to an embodiment of the present application, as shown in the drawing, the inner clip assembly includes a first inner clip arm 121 and a second inner clip arm 122, wherein the proximal end of the first inner clip arm 121 is hinged to the first hinge portion of the first spacer plate 115, the proximal end of the second inner clip arm 122 is hinged to the first hinge portion 113 of the second spacer plate 116, the first inner clip arm 121 and the second inner clip arm 122 have the same rigidity, i.e. the first inner clip arm 121 has a second rigidity, and the second inner clip arm 122 also has a second rigidity, which is smaller than or equal to the first rigidity in an embodiment, and is larger than the first rigidity in another embodiment. In the present application, the second rigidity means that the forces from the spacer member 11 and the outer clip member 14 are received at both the proximal and distal ends of the first inner clip arm 121 or the second inner clip arm 122, and the deformation of the plate body of the first inner clip arm 121 or the second inner clip arm 122 is not caused. The distal ends of the first inner clamping arm 121 and the second inner clamping arm 122 are respectively provided with a second hinge portion 123.

In an embodiment, the spacer element 11, the inner clip assembly 12 and the outer clip element 14 may be made of the same material, for example, the spacer element 11, the inner clip assembly 12 and the outer clip element 14 may be obtained by cutting nitinol material or nitinol material with laser, and in order to ensure rigidity distribution of the three, in this embodiment, the thickness of the plate body of the first inner clip arm 121 or the second inner clip arm 122 is greater than the thickness of the plate body of the first spacer plate 115 or the second spacer plate 116 in the spacer element 11, and the thickness of the plate body of the first inner clip arm 121 or the second inner clip arm 122 is greater than the thickness of the plate body of the first outer clip arm and the second outer clip arm in the outer clip element 14.

Referring to fig. 11, a schematic structural view of a first or a second inner clamping arm according to an embodiment of the present application is shown, in which, in this embodiment, a proximal end of the first inner clamping arm 121 has an outwardly curled hinge structure 1231, a distal end of the first inner clamping arm 121 has an inwardly curled hinge structure 1232, and correspondingly, a proximal end of the second inner clamping arm 122 has an outwardly curled hinge structure 1231, and a distal end of the second inner clamping arm 122 has an inwardly curled hinge structure 1232, and hinge points of the first inner clamping arm 121 and the second inner clamping arm 122 are distributed on different sides of two ends of each plate body, so that when the first inner clamping arm 121 and the second inner clamping arm 122 are subjected to a pushing force generated by the linear motion of the spacing element 11, the first inner clamping arm 121 and the second inner clamping arm 122 can more efficiently transmit a force, and a pushing force required by the driving shaft 20 of the conveying device is smaller, so that two inner clamping arms 14 of the inner clamping assembly can more easily open the two outer clamping elements 14.

In another embodiment, the first inner clamping arm 121 or the second inner clamping arm 122 may also be referred to as a clamping plate, and the clamping plate is a clamping plate with preset strength, so that the clamping plate is not easy to deform when two ends are stressed.

Referring to fig. 12, which is a schematic view of an expanded state of another embodiment of the valve repairing device according to the present application, as shown in the drawing, the first partition plate 115 and the second partition plate 116 of the above-mentioned partition element 11 are plate bodies with uneven widths, and in an embodiment in which the hinge structures 1131 and 1132 of the first partition plate 115 and the second partition plate 116 are offset from each other, correspondingly, the hinge structures 1231 and 1232 at the proximal ends and distal ends of the first inner clamp arm 121 and the second inner clamp arm 122 are offset from each other along the plate body direction thereof, so that the proximal ends of the first inner clamp arm 121 and the second inner clamp arm 122 are respectively hinged to the first hinge portion 113 at the distal ends of the first partition plate 115 and the second partition plate 116. Because of the narrower hinge width of the connection at the intersection of the first hinge 113, which in turn results in less friction, less thrust is required by the drive shaft 20 when the drive shaft 20 drives the spacer element 11 towards the distal end of the outer clip element 14 to open the outer clip arms of the outer clip element 14.

In an embodiment in which the plates of the first partition plate 115 and the second partition plate 116 of the partition element 11 are uniform in width, and the hinge structures formed at the distal ends thereof are two separate and outwardly curled hinge structures, respectively, the hinge structures at the proximal ends of the first inner clamping arm 121 and the second inner clamping arm 122 are aligned with the hinge structures at the distal ends thereof along the plate directions thereof, so that the proximal ends of the first inner clamping arm 122 and the second inner clamping arm 122 of the inner clamping assembly are hinged between the two separate and outwardly curled hinge structures, and the alignment is that the hinge structures at the proximal ends of the first inner clamping arm 121 or the second inner clamping arm 122 and the hinge structures at the distal ends are disposed on the same central axis, thereby ensuring the stress balance of the hinge points.

In the present application, in the embodiment shown in fig. 2 to 4 and fig. 12, the first inner clamping arm 121 and the second inner clamping arm 122 of the inner clamping assembly 12 are respectively provided with a first clamping piece 131 and a second clamping piece 132, in the embodiment shown in fig. 11, a plate body adjacent to the proximal end of the first inner clamping arm 121 is provided with an opening 1211 for passing through the first clamping piece 131, specifically, the opening 1211 is used for passing through a part of the first clamping piece 131 from one side (such as the front) to the other side (such as the back) of the plate body of the first inner clamping arm 121, correspondingly, the plate body adjacent to the proximal end of the second inner clamping arm 122 is provided with an opening for passing through the second clamping piece 132, specifically, the opening is used for passing through a part of the second clamping piece 132 from one side (such as the front) to the other side (such as the back) of the plate body of the second inner clamping arm 122, and in the embodiment, the first inner clamping arm 121 or the second clamping piece 121 is provided with a first clamping piece 131 or a first clamping piece 131 for being riveted or welded to the first clamping piece 122. In the present embodiment, the first clamping piece 131 and the second clamping piece 132 are fixed on the first inner clamping arm 121 and the second inner clamping arm 122 by welding, but not limited thereto, and in other embodiments, the first clamping piece 131 and the second clamping piece 132 may be fixed on the first inner clamping arm 121 and the second inner clamping arm 122 by riveting or screwing.

In the embodiment shown in fig. 11, the plates of the first inner clamping arm 121 and the second inner clamping arm 122 are respectively provided with a limiting block 1212, the limiting block 1212 is located near the distal ends of the plates of the first inner clamping arm 121 and the second inner clamping arm 122, the limiting block 1212 has a certain height, and since the first clamping piece 131 and the second clamping piece 132 are respectively disposed on the first inner clamping arm 121 and the second inner clamping arm 122 in an openable manner, for example, when the first clamping piece 131 is closed towards the first inner clamping arm 121 to be close to the surface (such as the front) of the first inner clamping arm 121, since one side of the first clamping piece 131 corresponding to the surface of the first inner clamping arm 121 is provided with a clamping piece, in order to ensure that the first clamping piece 131 is not directly attached to the surface of the first inner clamping arm 121 and the barb is pressed and deformed, a certain gap needs to be reserved between the first clamping piece 131 and the first inner clamping arm 121, and the first clamping piece 121 is disposed at a certain distance from each other, and the first clamping piece 131 is also correspondingly spaced from the second clamping piece 121.

In embodiments, a certain gap is reserved between the first clamping piece 131 and the first inner clamping arm 121, and is between 1mm and 3mm, specifically, in some embodiments, the gap is 1.1mm、1.2mm、1.3mm、1.4mm、1.5mm、1.6mm、1.7mm、1.8mm、1.9mm、2mm、2.1mm、2.2mm、2.3mm、2.4mm、2.5mm、2.6mm、2.7mm、2.8mm、2.9mm、 or 3mm.

In addition, since the first clamping piece 131 and the second clamping piece 132 are fixed on the plates of the first inner clamping arm 121 and the second inner clamping arm 122 by welding or riveting, when the first clamping piece or the second clamping piece is fixed on the plates of the first inner clamping arm 121 and the second inner clamping arm 122 as in the above example, the positioning accuracy of the fixing positions of the first clamping piece 131 and the second clamping piece 1212 needs to be ensured, the stopper 1212 on the plates of the first inner clamping arm 121 and the second inner clamping arm 122 has a positioning function here, so as to fix the first clamping piece 131 on the first inner clamping arm 121 as an example, a part (for example, an elastic structure of a tongue piece on the first clamping piece 131 later) of the first clamping piece 131 passes through the other side surface from the opening near the proximal end of the plate of the first inner clamping arm 121, and the first clamping piece 131 is fixed by welding or riveting, the first clamping piece 131 and the stopper 1212 are both positioned in the position space between the first clamping piece 131 and the first inner clamping arm 121, so that the barb 131 can be accurately positioned against the first clamping piece 131 in the first inner clamping piece 121 by the position of the first clamping piece 131.

Referring to fig. 13, a schematic diagram of the cooperation between the barbs and the puncture holes on the first clamping piece 131 and the inner clamping arm 122 in an embodiment of the present application is shown, in which, in an embodiment, the plate body of the first inner clamping arm 121 or the second inner clamping arm 122 is provided with the puncture holes or the puncture grooves 1214 corresponding to the barbs 1312 on the first clamping piece 131 or the second clamping piece 132, so that when the first clamping piece 131 and the second clamping piece 132 are clamped with the first inner clamping arm 121 and the second inner clamping arm 122, the barbs on the first clamping piece 131 or the second clamping piece 132 can puncture the puncture holes or the puncture grooves, and still take the first clamping piece 131 as an example for clamping the first inner clamping arm 121, and in the case that the natural valve is captured between the first clamping piece 131 and the first inner clamping arm 121, the barbs or the barbs on the first clamping piece 131 puncture the natural valve, and then puncture the puncture holes or the puncture grooves on the plate body of the first inner clamping arm 121, so as to more stably keep the natural valve between the first clamping piece 131 and the first clamping arm 121, thereby avoiding the risk of falling off of the heart valve device.

Referring to fig. 10 again, as shown in the drawing, the clip assembly 13 includes a first clip 131 and a second clip 132, wherein the first clip 131 has a fourth stiffness, and the second clip 132 also has a fourth stiffness, which is smaller than the third stiffness, that is, the first clip 131 and the second clip 132 have a more flexible elastic capability with respect to the first outer clip arm 141 and the second outer clip arm 142 of the outer clip element 14. In the present application, the first clip 131 and the second clip 132 are integrally formed as a spring structure. In an embodiment, the first clip 131 and the second clip 132 are made from a shape memory alloy sheet, such as by nitinol laser cutting.

In some embodiments, the clip assembly 13 is also referred to as a clip structure, and accordingly, the first clip 131 may also be referred to as a first clip and the second clip 132 may also be referred to as a second clip.

Referring to fig. 14, which is a schematic view of the expansion and closing of the clip assembly according to an embodiment of the present application, as shown in the drawing, in an embodiment, the first clip 131 is disposed on the first inner clip arm 121, and a traction portion 1313 is disposed at a distal end of the first clip 131, and specifically, the traction portion 1313 is a traction hole 1313, 1323 for passing through a traction wire. In one embodiment, the pulling hole 1313 is formed on the sheet body of the first clamping piece 131, in another embodiment, the pulling hole may be a perforated structure formed on the distal end of the first clamping piece 131 and curled outwards, the pulling hole 1313 of the first clamping piece 131 is opened relative to the first inner clamping arm 121 (in the state of the first clamping piece as shown in fig. 14) when being pulled by the pulling wire 30, correspondingly, the first clamping piece 131 is closed relative to the first inner clamping arm 121 due to its own elastic restoring force when the pulling force is eliminated (in the state of the second clamping piece as shown in fig. 14) when the pulling force is eliminated, correspondingly, the second clamping piece 132 is disposed on the second inner clamping arm 122, and the distal end of the second clamping piece 132 is respectively provided with a pulling portion 1323, specifically, the pulling portion 1323 is a pulling hole for threading the pulling wire 30. In one embodiment, the pulling element Kong Kaishe is formed on the sheet of the second clamping piece 132, and in another embodiment, the pulling hole is a perforated structure formed on the distal end of the second clamping piece 132 and curled outwards, and when the pulling hole of the second clamping piece 132 is pulled by the pulling wire 30, the pulling hole is opened relative to the second inner clamping arm 122, and accordingly, when the pulling force is removed, the second clamping piece 132 is closed relative to the second inner clamping arm 122 due to its own elastic restoring force. In this embodiment, the opening angle of the first clamping piece 131 or the second clamping piece 132 relative to the first inner clamping arm 121 or the second inner clamping arm 122, respectively, is controlled by the traction force of the traction wire.

In some embodiments, the pull wire 30 is also referred to as a control wire. In one embodiment, the traction wire 30 (control wire) may further be connected to a capturing ring 31, and the capturing ring 31 is connected to the traction wires in the first clip 131 and the second clip 132, respectively. The pull wires 30 connected by the first clip 131 and the second clip 132 are commonly connected to the same capture ring 31 for recycling the valve repair device 1 of the present application. For example, if the valve repair device 1 is found to be poorly clamped during a later routine examination, the valve repair device 1 needs to be re-clamped or otherwise withdrawn, the heart need not be opened, the snare is simply fed into the heart, the capture ring 31 is captured, the snare is pulled back after capture is completed, the first and second clips 131 and 132 are pulled up and opened, the captured native/native leaflets are re-released, and the snare continues to be pulled back, pulling the valve repair device 1 back into the sheath for retrieval.

In an embodiment, the proximal end of the first clamping piece 131 or the second clamping piece 132 has an elastic structure, so that an elastic restoring force can be provided for the first clamping piece 131 or the second clamping piece 132 when the traction force of the traction hole is eliminated, and in a specific implementation manner, the elastic structure can be realized by one or more modes of cutting, reducing materials, bending and the like on the sheet body of the clamping piece.

In an embodiment, a bending structure 1314 is formed adjacent to a proximal end portion of the first clip 131 or the second clip 132 to form a predetermined distance between a surface of the first clip 131 or the second clip 132 and a surface of the first inner clip arm 121 or the second inner clip arm 122. The bending structure 1314 also serves as an elastic structure to provide elastic restoring force to the clip, and is configured as shown in fig. 13.

In an embodiment, the elastic sheet body of the first clip 131 or the second clip 132 is a sheet body with uniform width, in another embodiment, the elastic sheet body is a sheet body with different width distribution, please refer to fig. 15, which shows a schematic diagram of a clip structure in another embodiment of the present application, as shown in the drawing, for example, the sheet body of the first clip 131 or the second clip 132 has one or more pairs of notch structures, that is, in this embodiment, the elasticity of the first clip 131 or the second clip 132 is increased by reducing the sheet material, and the notch structures are symmetrical structures on the sheet body, so as to ensure the uniformity of stress.

Referring to fig. 16, which is an exploded view of an assembly structure of a clip and an inner clip arm according to an embodiment of the present application, as shown in the drawing, the first clip 131 and the second clip 132 are fixed on the plate bodies of the first inner clip arm 121 and the second inner clip arm 122 by welding or riveting, in the above embodiment, the first clip 131 or the second clip 132 respectively includes an elastic sheet 1310 having a hollowed-out structure, a tongue piece 1311 extending from a proximal end of the elastic sheet, and a barb 1312 formed on the elastic sheet body 1310. Specifically, the elastic sheet 1310, the tongue 1311, and the barb 1312 are formed integrally on the first clip 131 or the second clip 132, for example, by cutting, clipping, or punching. In some cases, the tongue 1311 may also be a stator.

Referring to fig. 17, which illustrates an assembly structure of the first clamping piece 131 or the second clamping piece 132 according to an embodiment of the present application, as shown in the drawing, a portion of the first clamping piece 131 or the second clamping piece 132 adjacent to the proximal end thereof has a tongue piece 1311 extending from the proximal end of the elastic sheet 1310, the tongue piece 1311 has a certain length, a portion of the tongue piece 1311 is welded or riveted on the first inner clamping arm 121 or the second inner clamping arm 122, the first clamping piece is still fixed on the first inner clamping arm 121 by taking the first clamping piece as an example, the tongue piece 1311 of the first clamping piece passes through the opening 1211 of the first inner clamping arm 121 and is combined with the back surface of the first inner clamping arm 121, then the tongue piece 1311 is fixed on the back surface of the first inner clamping arm 121 by welding or riveting, and the main body portion (i.e. the portion with a barb) of the first clamping piece 131 is still located on the front surface of the first inner clamping arm 121, so that the first clamping piece 131 can be fixed on the first inner clamping arm 121, and the first clamping piece 131 can also be combined with the first clamping piece 131 by taking the elastic clamping arm 131 as an example, so that the first clamping piece 131 can be combined with the first clamping piece 131 and the corresponding inner clamping arm 121 by the first clamping piece 121.

In an embodiment, the barbs 1312 in the first clip 131 or the second clip 132 may have an included angle of 15 ° to 60 ° with respect to the elastic sheet 1310, and in this embodiment, the barbs 1312 extend in a direction inclined by 15 ° to 60 ° toward the proximal end of the first clip 131 or the second clip 132, and in some embodiments, the included angle may be 15°、16°、17°、18°、19°、20°、21°、22°、23°、24°、25°、26°、27°、28°、29°、30°、31°、32°、33°、34°、35°、36°、37°、38°、39°、40°、41°、42°、43°、44°、45°、46°、47°、48°、49°、50°、51°、52°、53°、54°、55°、56°、57°、58°、59°、 ° or 60 °. The angle of the barbs 1312 described above provides a further benefit in that the native leaflet can be disengaged when either the first clip 131 or the second clip 132 is pulled.

In embodiments, the barbs 1312 in the first clip 131 or the second clip 132 are 0.3-3mm in length, and in particular, in some embodiments, the barbs 1312 are 0.3mm、0.4mm、0.5mm、0.6mm、0.7mm、0.8mm、0.9mm、1mm、1.1mm、1.2mm、1.3mm、1.4mm、1.5mm、1.6mm、1.7mm、1.8mm、1.9mm、2mm、2.1mm、2.2mm、2.3mm、2.4mm、2.5mm、2.6mm、2.7mm、2.8mm、2.9mm、 or 3mm in length.

Referring to fig. 18, which is a schematic illustration of the barb configuration on the clip according to another embodiment of the present application, as shown, the root width of the barb in the first clip 131 or the second clip 132 is smaller than the central width thereof, i.e. each barb 131 extends from the elastic sheet at the above-mentioned inclination, the root 13121 thereof has a narrower width, then increases in width to transition to the central portion 13122, and then decreases in width until a sharper needle point 13123 is formed, so that the barb 1312 having the above-mentioned configuration better retains the native leaflet in the gap between the first clip 131 or the second clip 132 and the first inner clip arm 121 or the second inner clip arm 122 when penetrating the native leaflet.

In one embodiment, the number of barbs disposed on the resilient sheet of the first clip 131 or the second clip 132 is one, the group of barbs includes 3 barbs or 4 barbs 1312 aligned adjacent to the distal portion of the first clip 131 or the second clip 132, and in another embodiment, such as the embodiment shown in fig. 13 to 18, the number of barbs 1312 on the first clip 131 or the second clip 132 is multiple, wherein the number of barbs 1312 of one group adjacent to the distal portion is greater than the number of barbs 1312 of the other group, such as 3 barbs or 4 barbs of one group adjacent to the distal portion, and the number of barbs of the other group is 1 barb or 2 barbs.

In an embodiment, when the barbs on the first clip 131 or the second clip 132 are multiple groups, the barbs of each group may be arranged at regular intervals, for example, at regular fixed intervals or at regular intervals with gradual changes, and in an embodiment, the barbs of multiple groups may be arranged in a staggered manner, for example, the positions of the barbs are staggered in a second staggered manner.

In an embodiment, the first clamping piece 131 or the second clamping piece 132 is a double-layer elastic piece (not shown) including an inner layer elastic piece and an outer layer elastic piece, wherein the inner layer elastic piece is provided with barbs, the outer layer elastic piece is attached to the inner layer elastic piece to reinforce the elasticity or the clamping force of the clamping piece, and the inner layer elastic piece and the outer layer elastic piece are combined at the proximal end. In this embodiment, the manner of combining the inner layer elastic sheet and the outer layer elastic sheet at the proximal end may be welding or riveting, or the inner layer elastic sheet and the outer layer elastic sheet are in an integrally formed structure, and the combination of the inner layer elastic sheet and the outer layer elastic sheet at the proximal end portion is achieved through a bending manner.

Taking the first clip 131 as an example, the first clip 131 is a double-layer clip structure, and includes an inner layer clip and an outer layer clip, where, in order to increase the elastic capability of the outer layer clip, the outer layer clip may be a hollow structure, and the inner layer clip has a hollow elastic sheet body, a tongue piece extending from a proximal end of the elastic sheet body, and a barb formed on the elastic sheet body, where, the first clip 131 in the double-layer clip structure is fixed on the back of the first inner clip arm 121 by welding or riveting through the clip extending from the proximal end of the elastic sheet body on the inner layer clip, in this embodiment, a traction hole is formed at a distal end of the first clip 131 in the double-layer clip structure, specifically, a traction hole for a traction wire to pass through is provided at a position corresponding to the inner layer clip and the outer layer clip so as to force the first clip 131 to open relatively to the first inner clip arm 121 by traction force. Accordingly, the double-layer spring structure of the second clip 132 and the configuration method thereof are also the same.

In the present application, the outer clip element 14 is an integrally formed member, and in the embodiment shown in fig. 2 or 10, the outer clip element 14 is a U-shaped element, and the outer clip element 14 includes a first outer clip arm 141, a second outer clip arm 142, a distal end 143 at which the first outer clip arm 141 and the second outer clip arm 142 are integrally combined at distal ends, and a hinge 123 formed at proximal ends of the first outer clip arm 141 and the second outer clip arm 142, respectively. The first outer arm 141 has a third stiffness and the second outer arm 142 also has the same third stiffness, and in the present application, the stiffness of the whole of the first outer arm 141 or the second outer arm 142 is defined as the third stiffness, and the stiffness distribution of the first outer arm 141 or the second outer arm 142 in the vicinity of the proximal end is smaller than the stiffness distribution in the vicinity of the distal end. The first outer clamping arm 141 and the second outer clamping arm 142 form a clamping space, and the first outer clamping arm 141 and the second outer clamping arm 142 maintain opposite clamping forces in a state that the spacer element 11, the clamping piece assembly 13, and the inner clamping assembly 12 are positioned in the clamping space.

In some embodiments, the outer clamping member 14 may also be referred to as a U-shaped structure surrounded by two power assisting sheets, and the first outer clamping arm 141 or the second outer clamping arm 142 of the outer clamping member 14 may also be referred to as a clamping bar.

Referring to fig. 19 together with fig. 2 to 4, fig. 19 is a schematic view showing the clamping state of the outer clamping element in an embodiment of the present application, as shown in the drawing, the outer clamping element 14 includes a distal end 143 and a first outer clamping arm 141 and a second outer clamping arm 142 integrally formed with the distal end 143 and having a third stiffness, proximal ends of the first outer clamping arm 141 and the second outer clamping arm 142 are respectively hinged to the second hinge 123, in this embodiment, a hinge structure formed by proximal ends of the first outer clamping arm 141 or the second outer clamping arm 142 is two separate and outwardly curled hinge structures, and the first inner clamping arm 121 and the second inner clamping arm 122 for hinging the inner clamping element are respectively and laterally opened by the spacing element 11, so that the first inner clamping arm 121 and the second inner clamping arm 122 of the inner clamping element are respectively opened to both sides by the hinging movement of the second hinge 123, and the first inner clamping arm 121 and the second inner clamping arm 122 are respectively kept in a space between the inner clamping element and the second clamping element 11 and the second clamping element 122 due to the elastic restoring force of the first outer clamping element 121 and the second clamping element 122, and the inner clamping element 141 and the second clamping element 13 are further clamped by the elastic clamping element 141.

In the embodiment shown in fig. 2 or fig. 3 and fig. 19, the proximal end of the first outer clip arm 141 or the second outer clip arm 142 has the same width as the distal end 143, that is, the first outer clip arm 141 and the second outer clip arm 142 are each plate bodies having the same width, and in this embodiment, in order to ensure that the stiffness distribution of the first outer clip arm 141 or the second outer clip arm 142 adjacent to the proximal end is smaller than the stiffness distribution of the first outer clip arm 141 or the second outer clip arm 142 adjacent to the distal end, the first outer clip arm 141 or the second outer clip arm 142 has a structure in which the thickness increases from the proximal end toward the distal end 143, as shown in fig. 19, the first outer clip arm 141 or the second outer clip arm 142 has a plate body thickness d1 adjacent to the proximal end portion thereof, and the first outer clip arm 141 or the second outer clip arm 142 has a plate body thickness d2 adjacent to the distal end portion thereof, the thickness d1< thickness d2, so that the first outer clip arm 141 or the second outer clip arm 142 has a larger capacity than the second outer clip arm 142 adjacent to the distal end portion thereof. In the present application, the stiffness profile of the first or second outer clip arms 141, 142, including the proximal portion and the distal end 143, is a gradual rather than abrupt stiffness profile.

In the embodiment in which the first outer clip arm 141 or the second outer clip arm 142 are plate bodies with the same width, the hinge structure formed at the proximal end of the first outer clip arm 141 or the second outer clip arm 142 is two separate hinge structures 1410, 1420 that are curled outwards, so that the distal hinge structure 1231 or 1232 of the first inner clip arm 121 or the second inner clip arm 122 is hinged between the two separate hinge structures 1410, 1420 that are curled outwards, thereby forming a stable hinge for pivoting, and ensuring the stress balance of the hinge point.

In an embodiment, the width of the first outer clamping arm 141 or the second outer clamping arm 142 is larger than the width of the first inner clamping arm 121 or the second inner clamping arm 122, and the width of the first outer clamping arm 141 or the second outer clamping arm 142 is larger than the width of the first clamping piece 131 or the second clamping piece 132, so as to cover the spacer element 11, the inner clamping component and the clamping piece component when the outer clamping element 14 is folded to clamp the clamping space.

Referring to fig. 20, a schematic structural view of an outer clip element according to an embodiment of the present application is shown, in which the hinge structure formed by the proximal ends of the first outer clip arm 141 or the second outer clip arm 142 is an outwardly curled hinge structure 1410, 1420, and the hinge structures 1410 and 1420 of the first outer clip arm 141 and the second outer clip arm 142 are offset from each other, so that the proximal ends of the first outer clip arm 141 or the second outer clip arm 142 are correspondingly hinged to the second hinge portion 123 of the distal ends of the first inner clip arm 121 and the second inner clip arm 122, respectively (for ease of understanding, only one side of the inner clip arm and clip is shown in fig. 20). Because of the narrower hinge width at the junction of the second hinge 123, and thus the lower friction, when the drive shaft 20 drives the spacer element 11 to move toward the distal end 143 of the outer clip element 14 to open the two inner clip arms of the inner clip element, the lower friction at the hinge does not affect the force applied by the two inner clip arms when the two inner clip arms spread apart the first outer clip arm 141 and the second outer clip arm 142. As shown in fig. 12, the width of the proximal end of the first outer arm 141 or the second outer arm 142 is different from the width of the distal end 143, that is, the first outer arm 141 and the second outer arm 142 are plate bodies with different widths, specifically, taking the first outer arm 141 as an example, the first outer arm 141 has a structure with decreasing width from the distal end 143 toward the proximal end, and correspondingly, the second outer arm 142 has the same structure. Fig. 21 is a schematic view of a valve repair device according to another embodiment of the present application, as shown in fig. 21.

Referring to fig. 22, which is a side view of an outer clip element according to an embodiment of the present application, in order to reduce the force applied when the first outer clip arm 141 and the second outer clip arm 142 are opened, in this embodiment, the projection points o of the hinge structures 1410 and 1420 at the proximal ends of the first outer clip arm 141 or the second outer clip arm 142 fall outside the first outer clip arm 141 or the second outer clip arm 142 (as shown by the dashed line in fig. 19), and in this embodiment, taking the first outer clip arm 141 as an example, the hinge structure at the distal end of the first outer clip arm 141 is an outwardly curled hinge structure 1410, and the curled axis is located outside the projection of the first outer clip arm 141, so that the second hinge portion 123 has a better force point, and accordingly, the hinge structure 1420 at the distal end of the second outer clip arm 142 is also the same structural configuration. In the present embodiment, less force is required when the first and second inner arms 121 and 122 prop up the first and second outer arms 141 and 142.

In the embodiment shown in fig. 22, the first outer clip arm 141 and the second outer clip arm 142 extend from the distal end 143 toward the proximal end thereof and respectively include a first curved section a, a second curved section b, and a third curved section c, wherein a maximum distance w1 between the first curved sections a of the first outer clip arm 141 and the second outer clip arm 142 is smaller than a maximum distance w2 between the second curved sections b, and a maximum distance w1 between the first curved sections a of the first outer clip arm 141 and the second outer clip arm 142 is greater than or equal to a minimum distance w3 between the third curved sections c, that is, w3≤w1 < w2.

Referring to fig. 23, which is a side view of an outer clip element according to another embodiment of the present application, in the present embodiment, the outer clip element 14 is a U-shaped piece, the first outer clip arm 141 and the second outer clip arm 142 extend from the distal end 143 toward the proximal end thereof and respectively include a first curved section a, a second curved section b, and a third curved section c, in the present embodiment, a maximum distance between the first curved sections a of the first outer clip arm 141 and the second outer clip arm 142 is w1, a maximum distance between the second curved sections b of the first outer clip arm 141 and the second outer clip arm 142 is w2, and a minimum distance between the third curved sections c of the first outer clip arm 141 and the second outer clip arm 142 is w3, that is, w3 is less than or equal to w1< w2. In the embodiment for realizing the above-mentioned distance relationship, as shown in fig. 22 and 23, the projection point o of the hinge structure at the proximal end of the first outer arm 141 or the second outer arm 142 falls outside the first outer arm 141 or the second outer arm 142, and the projection point o of the hinge structure at the proximal end of the first outer arm 141 or the second outer arm 142 falls inside the first outer arm 141 or the second outer arm 142.

In the embodiment shown in fig. 23, in order to increase the opposite clamping force of the first outer clamping arm 141 and the second outer clamping arm 142 in the normal state, the clamping space formed by the first outer clamping arm 141 and the second outer clamping arm 142 has a smaller opening, that is, the projection point o of the hinge structure at the proximal end of the first outer clamping arm 141 or the second outer clamping arm 142 falls inside the first outer clamping arm 141 or the second outer clamping arm 142 and falls in the clamping space, and in this embodiment, a larger force is required when the first inner clamping arm 121 and the second inner clamping arm 122 support the first outer clamping arm 141 and the second outer clamping arm 142.

Referring to fig. 24, which is a side view of an outer clip element according to another embodiment of the present application, the first outer clip arm 141 and the second outer clip arm 142 respectively include a curved section a and a straight section d extending from the distal end 143 toward the proximal end thereof. In this embodiment, the maximum distance between the curved sections a of the first outer clamping arm 141 and the second outer clamping arm 142 is w1, and the maximum distance between the straight sections d of the first outer clamping arm 141 and the second outer clamping arm 142 is also w1, as shown in fig. 24.

Referring to fig. 25, which is a schematic view showing the engagement of the outer clip member with the driving shaft in an embodiment of the present application, as shown, the first outer clip arm 141 and the second outer clip arm 142 of the outer clip member 14 are combined into a distal end 143 at the distal end, the distal end 143 has a screw hole 1431 for screwing the driving shaft 20 of the delivery device, in the initial configuration of the valve repair device, the driving shaft 20 of the delivery device extends through the through hole of the connection portion of the spacing member 11 and the gap between the first spacing plate 115 and the second spacing plate 116 and is screwed into the screw hole 1431 of the distal end 143, when the driving shaft 20 is retracted proximally, the spacing member 11 is driven to move linearly with respect to the distal end 143, and the first inner clip arm 121 and the second inner clip arm 122 hinged at the first hinge portion 113 are driven by the spacing member 11 to open, the first and second inner arms 121 and 122 are supported by the first and second outer arms 141 and 142 hinged to the second hinge portion 123, when the first and second outer arms 141 and 142 having a small rigidity are supported to the maximum extent, the distal ends of the spacing member 11 connected to the first hinge portion 113 and the proximal ends of the first and second inner arms 121 and 122 approach the distal end 143 of the outer frame assembly, and at this time, the first and second inner arms 121 and 122 are folded so that the proximal ends thereof approach the distal end 143 of the outer frame member 14, and the first and second outer arms 141 and 142 force the inner frame assembly to engage the respective sides of the spacing member 11 due to elastic restoring force, and at this time, the valve repair device is in a closed state, that is, a state shown in fig. 25. After this operation, the drive shaft 20 of the delivery device is disengaged from the screw bore 1431 by rotation so that the drive shaft 20 is withdrawn to the valve repair device.

Referring to fig. 26, a schematic structural diagram of an outer clip member according to another embodiment of the present application is shown, in which the distal end 143 of the outer clip member 14 is an arc-shaped thickened structure or a base structure integrally formed at the bottom thereof.

In one embodiment, the outer clip element 14 is provided with shaft holes 1432 on either side of the distal end 143. In this embodiment, the distal end 143 of the outer clip member 14 is flanked by two sides in the second direction, each of which has two shaft holes 1432 for coupling to the frame members so that the two frame members are rotatably coupled to the two sides of the distal end 143 of the outer clip member 14.

In some embodiments, the outer clip element 14 is provided with shaft holes 1432, or side channels, on either side of the distal end 143.

Referring to fig. 27, which is a schematic view illustrating an arrangement of outer frame components in a valve repairing device according to an embodiment of the present application, in this embodiment, the valve repairing device 1 further includes an outer frame component 15 for wrapping a covering material, the outer frame component 15 includes a first outer frame 151 and a second outer frame 152, the first outer frame 151 and the second outer frame 152 are each a frame structure formed by bending a strip-shaped member, and the first outer frame 151 and the second outer frame 152 are rotatably coupled in shaft holes 1432 on two sides of a distal end 143 of the outer clip element 14 so as to cover the first outer clip arm 141 or the second outer clip arm 142 in a closed state, respectively.

In some embodiments, the first outer frame 151 or the second outer frame 152 of the outer frame assembly may also be referred to as an auxiliary clamp.

Referring to fig. 28, which is a schematic view of an outer frame structure of an outer frame assembly according to an embodiment of the present application, for convenience of understanding, three views are provided in fig. 28, wherein (a) in fig. 28 is a perspective view of the outer frame structure, (b) in fig. 28 is a front view of the outer frame structure, and (c) in fig. 28 is a schematic view of the first and second outer frames in a folded state, and in this embodiment, the first outer frame 151 or the second outer frame 152 is bent to form a leaflet structure, and it should be understood that the bent leaflet structure refers to a structure similar to a petal or a plant leaf after the first outer frame 151 or the second outer frame 152 is wrapped by a cover.

As shown in fig. 28, taking the first outer frame 151 as an example, the first outer frame 151 formed by the strip-shaped members includes a first section L1 extending a first length in a second direction, a second section L2 extending a second length in a third direction, a third section L3 bent in an everting shape to a third length, a fourth section L4 extending a fourth length in the second direction, a fifth section L5 bent in an everting shape to a third length, a sixth section L6 extending a second length in the third direction, and a seventh section L7 extending a first length in the second direction, wherein the length of the first section L1 is equal to the seventh section L7, the length of the second section L2 is equal to the sixth section L6, the length of the third section L3 is equal to the fifth section L5, the first section L1 and the seventh section L7 are shaft-contact portions of shaft holes on both sides of the distal end 143 of the outer clip element 14, and the second section L2, the third section L3, the fourth section L4, the fifth section L5 and the fifth section L5 are formed in a frame structure extending gradually from the outer side of the frame structure toward the outer frame.

In an embodiment, the first outer frame 151 and the second outer frame 152 of the outer frame assembly are each required to be wrapped with a covering material, and in order to make the covering material wrapped on the frame body thereof more firm, a hemming structure 150 is provided at a proximal end of the frame body structure, and the hemming structure 150 is formed on the fourth section L4 extending a fourth length in the second direction so as to be better combined with the covering material.

In an embodiment, when the first outer frame 151 and the second outer frame 152 of the outer frame assembly are covered with the first outer clamping arm 141 and the second outer clamping arm 142 in the closed state, a gap between the first outer frame 151 and the middle of the second outer frame 152 is not greater than 3mm, preferably, a gap between the first outer frame 151 and the middle of the second outer frame 152 is between 1mm and 3 mm.

Referring now to fig. 29 and 30, fig. 29 is a schematic view of a valve repair device of the present application in an embodiment with a cover material covered closed, and fig. 30 is a schematic view of a valve repair device of the present application in an embodiment with a cover material covered open, as shown, in which the valve repair device 1 further comprises a cover material 16 for covering the spacer element 11, the inner clip assembly 12, the clip assembly 13, the outer clip element 14, and the outer frame assembly 15, wherein the cover material 16 may be configured to prevent or reduce blood flow through the valve repair device and/or to promote natural tissue ingrowth. In embodiments, when the valve repair device captures and retains the native valve leaflets in a closed state, the retained native valve leaflets are largely encapsulated by the covering material 16, thereby reducing the likelihood of thrombosis and reducing the time required for endothelialization.

In some embodiments, the cover material 16 may be a cloth or woven material, such as PET, wool, or other suitable woven material. In other embodiments, the cover material 16 may include a coating, such as a polymer (e.g., natural polymer), a polymeric material, applied to the valve repair device, in place of or in addition to the woven material. In embodiments, the cover material 16 may be coated or otherwise carried with a functional drug for accelerating endothelialization of the valve repair device. In one embodiment, the cloth is, for example, a polyethylene cloth. Such as fine mesh polyethylene cloth, the cloth cover may provide a blood seal on the spacer surface and/or promote rapid tissue ingrowth.

Referring to fig. 31, a schematic view of an open state of the valve repair device covered with covering material is shown, in which the spacer element 11 and the covering material 16 covered on the clip assembly 13 are integrally woven with each other, and the inner clip assembly 12, the outer clip element 14, and the outer frame assembly 15 are integrally woven with each other. Wherein barbs on the clip assembly 13 are exposed through the cover material 16 to capture the valve. In other words, in the valve repair device, the separate braiding of two parts is included, wherein the first and second jaws 131 and 132 of the spacer element 11 and the jaw assembly 13 are wrapped with one piece/piece of braid, and the first and second inner arms 121 and 122 of the inner jaw assembly 12, the first and second outer arms 141 and 142 and the distal end 143 of the outer jaw element 14, and the first and second outer frames 151 and 152 of the outer frame assembly 15 are wrapped with another piece/piece of braid, such that each part of the valve repair device has more stretch and fatigue resistance.

In the present application, the "integral braiding" means that part of the braided wire of the braid is continuous and uninterrupted, for example, the braided material wrapped on the inner clip assembly 12, the outer clip element 14 and the outer frame assembly 15 is integrally braided, and part of the braided wire wrapped on the braided material of the inner clip assembly 12, the outer clip element 14 and the outer frame assembly 15 is continuous and uninterrupted, that is, the inner clip assembly 12, the outer clip element 14 and the outer frame assembly 15 are wrapped by a single piece or a whole piece of braided fabric, so that the braided fabric can not only improve the sealing effect on the covering of the inner wrapped element, but also make the wrapped parts have more stretch-proof and fatigue-proof properties.

In an embodiment, the first outer frame 151 and the second outer frame 152 of the outer frame assembly 15 are in a leaflet structure in a state of being wrapped with the covering material 16, and the wrapping space of the leaflet structure can wrap the first outer clamping arm 141 or the second outer clamping arm 142 therein, so as to further play a role of shielding the first outer clamping arm 141 or the second outer clamping arm 142. In the present embodiment, the first outer frame 151 and the first outer clip arm 141 are wrapped with the cover material 16 so that the first outer frame 151 and the first outer clip arm 141 are integrated, and the second outer frame 152 and the second outer clip arm 142 are wrapped with the cover material 16 so that the second outer frame 152 and the second outer clip arm 142 are integrated.

In an embodiment, in a state that the first inner clamping arm 121 and the second inner clamping arm 122 of the inner clamping assembly 12 are wrapped with the covering material 16, the tongue piece of the first clamping piece 131 and the tongue piece of the second clamping piece 132 fixed on the first inner clamping arm 121 and the second inner clamping arm 122 are wrapped together, so that the tongue piece of the first inner clamping arm 121 and the tongue piece of the first clamping piece 131 are wrapped together and combined into a whole, and the tongue piece of the second inner clamping arm 122 and the tongue piece of the second clamping piece 132 are wrapped together and combined into a whole.

In an embodiment, the spacer element 11 is covered with the covering material 16, and the connection portion of the spacer element is used for being engaged with the ear-shaped fixture of the release structure of the conveying device to leak out of the covering material 16 so as to be engaged with the release structure. In the present embodiment, the first and second partition plates 115 and 116 of the spacer member 11 are integrally wrapped with the cover material 16, with the gap therebetween being shielded inside by the cover material 16.

In another embodiment, the valve repair device 1 further comprises a cover material 16 for wrapping the spacer element 11, the inner clip assembly 12, the clip assembly 13, and the outer clip element 14, wherein barbs on the clip assembly 13 are exposed through the cover material 16 to capture the valve. In this embodiment, the spacer element 11 and the covering material 16 wrapped on the clip assembly 13 are integrally woven, and the inner clip assembly 12 and the outer clip element 14 are integrally woven.

For further description of the inventive concepts and principles of the present application, and with reference to fig. 2-4, the valve repair device 1 may assume a plurality of state transitions, such as an extended state, an open state, and a closed state, during actual surgical application, wherein when the valve repair device 1 is deployed in a delivery catheter/delivery sheath of a delivery device, it is constrained to the extended state, the delivery sheath of the delivery device is inserted into the left atrium through the septum, and the valve repair device 1 extends out of the delivery sheath to assume its extended state, wherein the proximal connection portion of the spacer element 11 is in snap-fit connection with the distal end of the delivery catheter/delivery sheath, and wherein the first inner clip arm 121 and the second inner clip arm 122 hinged to the first hinge portion 113 at the distal end of the spacer element 11 are in approximately conforming states, and the first outer clip arm 141 and the second outer clip arm 142 of the outer clip element 14 respectively hinged to the first hinge portion 113 at the distal end of the first inner clip arm 121 and the second inner clip arm 122 are in a normally U-shaped configuration due to the constraint of the inner space of the delivery catheter/delivery sheath.

The valve repair device 1 is delivered to the mitral valve site into the left ventricle and is partially opened to assume an inverted umbrella-like shape, so that when the jaws on the inner arms on both sides thereof are operated to capture the native valve leaflet, the first jaw 131 or the second jaw 132 are opened relative to the first inner arm 121 or the second inner arm 122 by operating the pull wire penetrating the distal end of the first jaw 131 or the second jaw 132 to capture the native valve leaflet, at this time, the spacer element 11 is moved toward the distal end 143 of the outer element 14 by operating the drive shaft 20 (central rod) of the delivery device (which can also be understood as the distal end 143 of the outer element 14 is moved toward the spacer element 11), and the first inner arm 121 and the second inner arm 122 hinged at the first hinge 113 are simultaneously opened on both sides (outside) due to the pivot or pivot structure provided by the first hinge 113, and the second inner arms 121 and 122 are correspondingly also simultaneously fixed at the first inner arm 121 and the second inner arm 122 along with the first inner arm 121 and the second inner arm 132 (which are also simultaneously opened on both sides of the second inner arm 121 and the second inner arm 122) are gradually provided with a large degree of rigidity by the first hinge arm 142 and the second outer arm 142 and the second hinge arm 142 (which are simultaneously opened on both sides of the first hinge arm 142 and the second outer arm 142 are provided by the pivot shaft or the second hinge arm 142. The valve repair device 1 assumes an open state in which it resembles an umbrella.

Continuing to move the spacer element 11 towards the distal end 143 of the outer gripping element 14 by operating the drive shaft 20 (central core rod) of the delivery device, the distal end portion of the spacer element 11 enters the gripping space formed by the first outer gripping arm 141 and the second outer gripping arm 142 in the U-shaped configuration and gradually approaches the distal end 143 of the outer gripping element 14, at which time one end is hinged at the first hinge 113 and the other end is hinged at the second hinge 123, the proximal and distal ends of the first inner gripping arm 121 and the second inner gripping arm 122 are interchanged, during which process the first gripping arm 131 and the second gripping arm 132 are released by controlling the traction wire so as to grip the native valve on one side between the first gripping arm 131 and the first inner gripping arm 121, the native valve on the other side between the second gripping arm 132 and the second inner gripping arm 122, and continuing to move downwards at the spacer element 11 so as to bring about inward (in the direction of the central axis of the spacer element 11), at which time the first inner gripping arm 121 and the second inner gripping arm 122 are folded inwards (in the direction of the central axis of the spacer element 11), the elastic force of the outer gripping arm 141 and the second outer gripping arm 142 is maintained in the state of the assembly of the outer gripping element 1 and the respective elastic force of the spacer element 141 is maintained by the elastic member and the inner gripping element 141 and the outer gripping assembly of the spacer element 1.

At this time, the valve repair device 1 is held on the native valve by operating the drive shaft 20 of the delivery device to disengage from the screw hole 1431 of the outer clip element 14, and then by operating the release structure of the delivery catheter/delivery sheath distal end of the delivery device to disengage the drive shaft 20 to release the engagement of the ear-like clips on the spacer element 11 and to withdraw the pull wire from the pull holes of the first clip 131 and the second clip 132, thus completing the partial closure of the native valve.

The valve repairing device provided by the application adopts two hinge structures to hinge the spacing element and the inner clamp assembly at the first position, and hinges the inner clamp assembly and the outer clamp element with a U-shaped structure at the second position, wherein the two hinge structures have better flexibility effect compared with the valve repairing clamp disclosed in the related art (for example, china patent publication No. CN 111449805A) by adopting only one hinge structure and adopting a folding structure at the other position, the valve repairing device has smaller force required by driving the spacing element to move towards the distal end part of the outer clamp element by a driving shaft, thereby being beneficial to the precision control of a doctor in operation, and furthermore, the valve repairing device adopts an integrally formed U-shaped outer clamp element, and continuously maintains opposite clamping force for each assembly/element in a clamping space by utilizing the rigidity design of the outer clamp arm, has more stable performance compared with the clamping effect by adopting mechanical locking in the related art, and adopts an integrally formed U-shaped outer clamp element, has more simple clamping mode in structure compared with the related art, has more stable elastic clamping force provided by a frame/piece, and has more stable clamping effect compared with the elastic clamping force provided by the frame/piece in the related art, and compared with the valve repairing clamp disclosed in the prior art (for example, the valve repairing clamp disclosed in China patent publication No. CN has simple and has the manufacturing technology of weaving and has more than that the outer clamp is prepared by adopting a metal clamp.

The above embodiments are merely illustrative of the principles of the present application and its effectiveness, and are not intended to limit the application. Modifications and variations may be made to the above-described embodiments by those skilled in the art without departing from the spirit and scope of the application. Accordingly, it is intended that all equivalent modifications and variations of the application be covered by the claims, which are within the ordinary skill of the art, be within the spirit and scope of the present disclosure.

Claims

1. A valve repair device, comprising:

A spacer element comprising a spacer body having a first stiffness, the proximal end of the spacer body being provided with a connection portion for connecting a delivery device, the opposite sides of the distal end of the spacer body being provided with respective first hinge portions;

The inner clamp assembly comprises a first inner clamp arm and a second inner clamp arm which respectively have second rigidity, wherein the proximal ends of the first inner clamp arm and the second inner clamp arm are respectively hinged to the first hinge part;

The clamping piece assembly is arranged on the inner clamping piece assembly or hinged to the first hinge part and comprises a first clamping piece which can be opened or closed relative to the first inner clamping arm and a second clamping piece which can be opened or closed relative to the second inner clamping arm, and the distal ends of the first clamping piece and the second clamping piece are respectively provided with a traction part;

An outer clip element comprising a distal end, first and second outer clip arms integrally formed with the distal end; the first outer clamping arm and the second outer clamping arm respectively have third rigidity, a clamping space is formed between the first outer clamping arm and the second outer clamping arm, and the first outer clamping arm and the second outer clamping arm keep opposite clamping force in a state that the spacing element, the clamping piece component and the inner clamping component are positioned in the clamping space;

The first outer clip arm or the second outer clip arm is in a structure with gradually increased width from the proximal end towards the distal end, and the distal end of the outer clip element is in an arc-shaped thickening structure or a base structure integrally formed at the bottom of the outer clip element.

2. The valve repair device of claim 1, wherein the overall stiffness of the spacer element is defined as a first stiffness, the first stiffness being greater than or equal to the second stiffness, the second stiffness being greater than the third stiffness.

3. The valve repair device of claim 1 wherein the overall stiffness of the spacer element is defined as a first stiffness, the first stiffness being less than the second stiffness, the second stiffness being greater than the third stiffness.

4. The valve repair device of claim 1, wherein the first clip or second clip has a fourth stiffness that is less than the third stiffness.

5. The valve repair device of claim 1, wherein the overall stiffness of the first or second outer clip arms is defined as a third stiffness, the stiffness profile of the first or second outer clip arms being less proximate than the stiffness profile of the distal portions.

6. The valve repair device of claim 1, wherein the spacer element comprises, in order from the proximal end toward the distal end, a connector, a neck, first and second spacer plates separated from the neck and extending distally, and a hinge structure formed at distal ends of the first and second spacer plates, respectively, the connector, neck, first and second spacer plates, and hinge structure being integrally formed.

7. The valve repair device of claim 6, wherein the connector is higher than the clip assembly or inner clip assembly or outer clip element in a state in which the spacer element, clip assembly, and inner clip assembly are located in the clip space.

8. The valve repair device of claim 6, wherein the connector of the spacer element is fixed with the connecting portion, the two opposite sides of the connecting portion are respectively provided with an ear-shaped clamping block for clamping the delivery device, and the connecting portion and the connector are provided with through holes for passing a driving shaft of the delivery device.

9. The valve repair device of claim 8, wherein the extending direction of the ear-shaped clamping blocks at two sides of the connecting part is parallel to the plate surfaces of the first and second partition plates.

10. The valve repair device of claim 6, wherein the neck comprises a bridge structure separating the first and second spacer plates, the bridge structure having a first directional width that is greater than a maximum separation width of the first and second spacer plates, and a second directional width that is less than a maximum width of a plate body of the first or second spacer plates.

11. The valve repair device of claim 6, wherein a gap is provided between distal ends of the first and second spacer plates through which a drive shaft of the delivery device passes.

12. The valve repair device of claim 6, wherein distal ends of the first and second spacer plates are joined to each other and a through hole is formed at the junction through which a drive shaft of the delivery device passes.

13. The valve repair device of claim 6, wherein the distal end of the first or second spacer plate forms a hinge structure as two separate and outwardly curled hinge structures.

14. The valve repair device of claim 6, wherein the distal end-forming hinge structure of the first or second spacer is an outwardly curled hinge structure, wherein the hinge structure of the first and second spacer are offset from each other.

15. The valve repair device of claim 6, wherein a maximum width of the first hinge portion of the first spacer plate and the first hinge portion of the second spacer plate in a first direction is no greater than a maximum width of the connecting portion of the spacer element in the first direction.

16. The valve repair device of claim 6, wherein the hinge structure of the first or second spacer plate toward its distal end is of decreasing width.

17. The valve repair device of claim 1, wherein the first or second inner clip has a thickness greater than the thickness of the first or second spacer, and wherein the first or second inner clip has a thickness greater than the thicknesses of the first and second outer clips.

18. The valve repair device of claim 1, wherein the proximal end of the first or second inner clip arm has an outwardly curled hinge structure and the distal end of the first or second inner clip arm has an inwardly curled hinge structure.

19. The valve repair device of claim 1, wherein the proximal hinge structure and the distal hinge structure of the first or second inner clip are offset from each other along the direction of the plate, or wherein the proximal hinge structure and the distal hinge structure of the first or second inner clip are offset from each other along the direction of the plate.

20. The valve repair device of claim 1, wherein a plate adjacent a proximal end of the first or second inner clip arms has an opening therein for threading the first or second clip such that a portion of the first or second clip passes through the opening from one side of the plate and is bonded to the other side.

21. The valve repair device of claim 1, wherein a stop is provided on the plate adjacent the distal end of the first or second inner clip for maintaining a spacing between the first or second clip and the first or second inner clip.

22. The valve repair device of claim 1, wherein a plate body of the first or second inner clip arm is provided with a fixing hole for welding or riveting the first or second clip.

23. The valve repair device of claim 1, wherein the plate body of the first or second inner clip arm is provided with a puncture or slot corresponding to the barb on the first or second clip.

24. The valve repair device of claim 1, wherein the traction portion of the distal end of the first clip or the second clip is a traction hole for threading a traction wire.

25. The valve repair device of claim 24, wherein the traction Kong Kaishe is on a sheet of the first or second clip, or wherein the traction aperture is a perforated structure formed at a distal end of the first or second clip that is crimped outward.

26. The valve repair device of claim 1, wherein the sheet of the first clip or second clip has at least one pair of notch structures.

27. The valve repair device of claim 1, wherein a proximal end of the first clip or second clip has a hinge structure for articulating to the first hinge.

28. The valve repair device of claim 1, wherein a proximal end of the first clip or second clip has a resilient structure.

29. The valve repair device of claim 1, wherein a kink structure is formed adjacent a proximal portion of the first clip or second clip such that a surface of the first clip or second clip forms a predetermined distance from a surface of the first inner clip arm or second inner clip arm.

30. The valve repair device of claim 1, wherein the first clip or the second clip is a double-layer clip comprising an inner clip and an outer clip, wherein the inner clip is provided with barbs, the outer clip engages the inner clip, and the inner clip and the outer clip are proximally joined.

31. The valve repair device of claim 30, wherein the outer shell fragment is hollowed out.

32. The valve repair device of claim 1, wherein the outer clip element is a U-shaped element, the distal ends of the first or second outer clip arms being integrally joined at the distal end of the U-shaped element.

33. The valve repair device of claim 1, wherein the hinge structure formed at the proximal end of the first or second outer clip arms is two separate and outwardly curled hinge structures.

34. The valve repair device of claim 1, wherein the proximal end of the first or second outer clip arm is the same width as the distal end.

35. The valve repair device of claim 1, wherein the hinge structure formed at the proximal end of the first or second outer clip arms is an outwardly curled hinge structure, and the hinge structures of the first and second outer clip arms are offset from one another.

36. The valve repair device of claim 1, wherein a projected point of the hinge structure proximal to the first or second outer clip arms falls outside of the first or second outer clip arms.

37. The valve repair device of claim 1, wherein the first or second outer clip arms are of increasing thickness from their proximal ends toward their distal ends.

38. The valve repair device of claim 1, wherein the first and second outer arms extend from the distal end toward the proximal end thereof and each comprise a first curved section, a second curved section, and a third curved section, wherein a maximum spacing between the first curved sections of the first and second outer arms is less than a maximum spacing between the second curved sections, and wherein a maximum spacing between the first curved sections of the first and second outer arms is greater than or equal to a minimum spacing between the third curved sections.

39. The valve repair device of claim 1, wherein the first and second outer clip arms extend from the distal end toward the proximal end thereof and comprise curved and straight sections, respectively.

40. The valve repair device of claim 1, wherein the distal end of the outer clip element has a screw hole for screwing the drive shaft of the delivery device.

41. The valve repair device of claim 1, wherein the outer clip element is provided with shaft holes on both sides of the distal end.

42. The valve repair device of claim 1, further comprising an outer frame assembly for wrapping with a covering material, the outer frame assembly comprising first and second outer frames respectively pivotally connected to opposite sides of the distal end of the outer clip element, the first or second outer frames being folded into a leaflet configuration so as to cover the first or second outer clip arms respectively in a closed state.

43. The valve repair device of claim 42, wherein the first or second outer frame comprises a shaft connection for shaft connection to both sides of the distal end of the outer clip element, and a frame structure extending proximally from the shaft connection and having an incrementally wider frame structure with an outwardly curved proximal end.

44. The valve repair device of claim 42, wherein the proximal end of the frame structure has a hemmed configuration.