CN216417422U

CN216417422U - Valve repair device

Info

Publication number: CN216417422U
Application number: CN202123207754.9U
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: 2022-05-03
Anticipated expiration: 2031-12-20
Also published as: CN216417421U; CN117045398A; CN114271993A; CN216417423U

Abstract

The present application discloses a valve repair device, the valve repair device comprising: the valve repair device adopts two hinge structures to respectively hinge the spacing element and the inner clamping assembly at a first position and hinge the inner clamping assembly and the outer clamping element in a U-shaped structure at a second position, so that smaller control force is required when clamping is realized, and precision control of a doctor during operation is facilitated; this application adopts integrated into one piece's U type to press from both sides the component outward, utilizes the elastic design of its outer arm lock to last each subassembly/component in the clamping space and keep the clamping-force in opposite directions, and the centre gripping mode simpler in structure.

Description

Valve repair device

Technical Field

The present application relates to the field of medical devices, and more particularly, to a valve repair device that facilitates repair of a native heart valve.

Background

In the cardiovascular system, native heart valves (e.g., aortic, pulmonary, mitral, and tricuspid valves) play a critical role in preserving the positive flow of an adequate supply of blood. However, these heart valves may be damaged by congenital malformations, inflammatory processes, infectious conditions, or diseases, thereby reducing their efficiency; such disease processes include, for example, degenerative processes (e.g., Barlow's disease or fibro-elastosis, etc.), inflammatory processes (e.g., rheumatic heart disease, etc.), and infectious processes (e.g., endocarditis, etc.). 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 dysfunction of the leaflets of the native valve (e.g., mitral valve), causing prolapse and regurgitation.

In the case of the mitral valve, mitral regurgitation may be caused by a number of different mechanical defects in the mitral valve or the left ventricular wall. The leaflets, the chordae connecting the leaflets to the papillary muscles, or the papillary muscles themselves or the left ventricular wall may be damaged or otherwise malfunction. Often, the annulus may be damaged, dilated or weakened, limiting the ability of the mitral valve to close sufficiently against the greater pressure of the left ventricle, which can lead to serious cardiovascular damage or death.

For many years, the 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 prone to many complications. As a result, elderly, infirm patients with defective heart valves are often left untreated. More recently, transvascular techniques have been developed for introducing and implanting prosthetic devices in a much less invasive manner 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 passing the catheter into the left atrium.

However, in the art of implantation treatment by the septal technique, the prosthetic devices such as the clip device usually employ very complicated mechanical structures to capture and hold the native valve, which imposes high operation requirements on the physician during the operation, and often fails to operate during the opening or turning of the clip due to the complicated mechanical structures of the clip device; after the clamping device clamps the natural valve, a mechanical locking mode is needed to keep the partial closure of the natural valve, but multiple clinical tests show that the risk of falling off the clamping device from the natural valve is generated along with long-time heart contraction through mechanical structure locking/locking.

Disclosure of Invention

In view of the above-mentioned shortcomings of the related art, the present application aims to provide a valve repair device for solving the problems of inconvenient operation due to complicated mechanical structure design of the clip and the falling-off risk due to mechanical locking/attaching manner in the related art.

To achieve the above and other related objects, the present application discloses a valve repair device including: the spacer element is provided with a connecting part used for connecting a conveying device at the proximal end, and the two opposite sides of the distal end are respectively provided with a first hinge part; the inner clamp assembly comprises a first inner clamp arm and a second inner clamp arm, and the near ends of the first inner clamp arm and the second inner clamp arm are respectively hinged to the first hinge part; the far ends of the first inner clamping arm and the second inner clamping arm are respectively provided with a second hinge part; the clamping piece assembly is arranged on the inner clamping assembly or hinged to the first hinged part and comprises a first clamping piece capable of opening or closing relative to the first inner clamping arm and a second clamping piece capable of opening or closing relative to the second inner clamping arm, and the far 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 and first and second outer clip arms integrally formed with the distal end; the near ends of the first outer clamping arm and the second outer clamping arm are respectively hinged with the second hinge part; and 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 the state that the spacing element, the clamping piece assembly and the inner clamping assembly are positioned in the clamping space.

In summary, the valve repair device provided by the application adopts two hinge structures to respectively hinge the spacing element and the inner clamp assembly at a first position and hinge the inner clamp assembly and the outer clamp element in a U-shaped structure at a second position, and the two hinge structures have better flexibility compared with the prior art that only one hinge structure is adopted at the other position and the folding structure is adopted at the other position, so that the application needs smaller force when the driving shaft drives the spacing element to move towards the distal end part of the outer clamp element, and is further beneficial to the precision control of a doctor during operation; furthermore, this application adopts integrated into one piece's U type to press from both sides the component outward, utilize the rigidity design of its outer arm lock to last to keep the clamping-force in opposite directions each subassembly/component in the clamping space, compare and adopt mechanical lock to attach to ensure that the clamping effect has more stable performance in the correlation technique, and this application adopts integrated into one piece's U type to press from both sides the component and provides the clamping means simple more in structure, compare and lean on frame/bar spare to provide elastic clamping force in the correlation technique and have more stable clamping effect, moreover, compare in the prior art adopt the metal to weave the outer of material folding formation, interior arm that presss from both sides has simpler preparation technology.

Drawings

The specific features of the invention to which this application relates are set forth in the appended claims. The features and advantages of the invention to which this application relates will be better understood by reference to the exemplary embodiments described in detail below and the accompanying drawings. The drawings are briefly described as follows:

fig. 1 is a schematic structural diagram of a conveying device according to an embodiment of the present disclosure.

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

Fig. 3 is a schematic view of the 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 a closed state in one embodiment.

Fig. 5 is a schematic view of an exploded structure of a spacer element according to an embodiment of the present application.

Fig. 6 is a schematic view of an assembly structure of the spacer elements according to an embodiment of the present application.

Fig. 7 is a schematic structural diagram of a spacer element according to another embodiment of the present application.

Figure 8 shows a side view of the spacer element of an embodiment of the present application in two directions.

Fig. 9 is a schematic structural diagram of a spacer element according to yet another embodiment of the present application.

Figure 10 is a schematic view of the present application illustrating the assembly of an inner clip assembly in one embodiment.

Fig. 11 is a schematic structural view of the first or second inner clamp arm according to an embodiment of the present application.

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

Fig. 13 is a schematic view of the present application showing the engagement of barbs and piercing holes on the clip and inner clip arm according to one embodiment.

FIG. 14 shows an embodiment of the present application showing the opening and closing of a clip assembly.

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

FIG. 16 is an exploded view of an embodiment of the present invention showing an assembly of a clip and an inner clip arm.

Fig. 17 is a schematic view illustrating an assembly structure of the clip and the inner clip arm according to an embodiment of the present invention.

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

FIG. 19 is a schematic view of the present application showing the outer clamping member in a clamped position in one embodiment.

FIG. 20 is a schematic view of an outer clip element according to an embodiment of the present application.

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

Figure 22 illustrates a side view of an outer clamp member of the present application in one embodiment.

Figure 23 shows a side view of an outer clamp member of another embodiment of the present application.

Figure 24 illustrates a side view of an outer clamp member according to yet another embodiment of the present application.

FIG. 25 is a schematic view of the present application showing the engagement of an outer clamp member with a drive shaft in one embodiment.

FIG. 26 is a schematic view of an outer clip element according to yet another embodiment of the present application.

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

FIG. 28 is a schematic diagram of an outer frame structure of the outer frame assembly according to an embodiment of the present invention.

Fig. 29 is a schematic view of a valve repair device of the present application, in one embodiment, coated with a covering material in a closed position.

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

Fig. 31 is a schematic view of a valve repair device of the present application in another embodiment, coated with a cover material in an open position.

Detailed Description

The following embodiments are provided to illustrate the present disclosure, and other advantages and effects will be apparent to those skilled in the art from the disclosure.

In the following description, reference is made to the accompanying drawings that 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," "below," "lower," "above," "upper," and the like, may be used herein to facilitate describing one element or feature's relationship to another element or feature as illustrated in the figures.

Although the terms first, second, etc. may be used herein to describe various elements or parameters in some instances, 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 clip arm may be referred to as a second inner clip arm, and similarly, the second inner clip arm may be referred to as a first inner clip arm, without departing from the scope of the various described embodiments. The first inner clip arm and the second inner clip arm are each described as one inner clip arm, but they are not the same inner clip arm unless the context clearly indicates otherwise. Similar situations also include a first clamping piece and a second clamping piece, or a first outer clamping arm and a second outer clamping arm.

Also, 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," when used in this specification, specify the presence of stated features, steps, operations, elements, components, items, species, and/or groups, but do not preclude the presence, or addition of one or more other features, steps, operations, elements, components, species, and/or groups thereof. 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 the following: 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 inherently mutually exclusive in some way.

During operation of the heart, the left atrium receives oxygenated blood from the lungs, during the diastolic phase or phase, through dilation of the left ventricle, and blood previously collected in the left atrium moves through the mitral valve and into the left ventricle during systole. In the systolic phase, or systolic phase, the left ventricle contracts to force blood into the body through the aortic valve and ascending aorta. During contraction, the leaflets of the mitral valve close to prevent blood from flowing back from the left ventricle and back into the left atrium, and blood collects in the left atrium from the pulmonary veins. In one exemplary embodiment, the valve repair devices described herein are used to repair the function of a defective mitral valve. That is, the valve repair device is configured to help close the leaflets of the mitral valve to prevent blood from flowing back from the left ventricle and back into the left atrium. In another exemplary embodiment, the valve repair device described herein 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, during actual surgical application; the valve repair device is implanted through a delivery catheter/sheath of a delivery device that is inserted through the septum into the left atrium and extends out of the delivery sheath to assume an extended state, partially opened to assume an umbrella shape when the valve repair device is delivered into the mitral valve into position in the left ventricle, with the native leaflets captured by operating the jaws on the inner clamping arms on both sides of the device to capture the native leaflets, which are then fully closed to effect clamping thereof against the native mitral valve.

In this application, when describing a 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, "outer" in the spatial terms "outside" or "outward" refers to a direction in which, in a reference direction in which the axis center of the spacer element is the inner central axis of the valve repair device, the radial direction of the central axis is the "outward" direction; such as both surfaces of the first or second spacer plate, a surface of a side facing the gap between the first and second spacer plates is defined as an inner surface, and a back surface of the inner surface is defined as an outer surface; accordingly, in the present application, a clamping space is formed between the 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 inner surfaces, and the back surfaces of the inner surfaces of the outer clamping arms are defined as outer surfaces.

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

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

In this 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 direct between the components or may be indirect, such as through the use of one or more intervening components. Also, as described herein, references to "an assembly," "a component," "a member," or "a portion" should not be limited to a single structural component, member, or element, but may include an assembly of components, members, or elements. Also, as used herein, the terms "substantially" and "about" are defined as at least close to (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 components by means of a hinge (hinge), and in a specific application, the hinge structure may be a shaft hole structure that matches with a rotating shaft, a rotating shaft that matches with the shaft hole, or a pivot structure; the hinge structure may be formed by folding or rolling a sheet of material.

In the present application, the term "rigidity" refers to the ability of a structure to resist elastic deformation when being subjected to a force, and the "rigidity" is used to represent the difficulty of structural deformation or the value of an external force required for structural deformation, for example, the rigidity of a spacer refers to the value of the external force required for deformation of the spacer, the rigidity of an inner clamp arm refers to the value of the external force required for deformation of the inner clamp arm, and the rigidity of an outer clamp arm refers to the value of the external force required for deformation of the outer clamp arm. 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 formed at one time by a processing process such as stamping, cutting, casting, etc., the structure being integrally one element and being inseparable.

The valve repair device described herein is implanted via a delivery catheter/sheath of a delivery device that is inserted through the septum into the left atrium and that extends from the delivery catheter/sheath and is caused to assume an extended state by controlling a drive shaft extending from the delivery catheter/sheath, the valve repair device being partially opened to assume an umbrella shape when delivered into the mitral valve into the left ventricle by operating clips on inner clip arms on either side of the device to capture native leaflets, the valve repair device being fully closed to effect clamping thereof to the native mitral valve after capture of the native leaflets, and then being released from the valve repair device by operating the drive shaft of the delivery device, i.e., by operating a release structure at the distal end of the delivery catheter/sheath of the delivery device, withdrawing the drive shaft releases the engagement of the coupling portions on the spacer element and withdraws the pull wire from the pull hole of the clip assembly, thus retaining the valve repair device on the native valve and completing partial clamping of the native valve.

Referring to fig. 1, which is a schematic structural diagram of a delivery device in an embodiment of the present invention, as shown in the drawing, in this embodiment, the delivery device 2 may sequentially include, from a proximal end to a distal end, a release mechanism 21, a delivery mechanism 22, an adjustable bending mechanism 23, a loader mechanism 24, and an outer sheath mechanism 25, 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 pass through and extend out of the adjustable elbow 230. The delivery handle 221 includes a delivery housing and a pull-cord control assembly 222. The far end of the conveying shell is connected with the near end of the conveying pipe 220, and a conveying end closure is detachably arranged at the end part of the far end of the conveying shell. The pull wire control assembly 222 can slide on the delivery housing in the axial direction of the delivery tube, the pull wire control assembly 222 is connected to the clip assembly of the valve repair device, the pull wire control assembly 222 controls the opening and closing of the clip assembly when sliding in the axial direction, and the number of knobs of the pull wire control assembly 222 is the same as the number of clips in the clip assembly, so that one knob controls the opening and closing of one clip. In this embodiment, the delivery device 2 is used in conjunction with a valve repair device, and in use, the delivery wires (pull wires) of the delivery structure 22 are detachably connected to the clips of the clip assembly of the valve repair device, and the drive shaft 20 (central core rod) of the release structure 22 is detachably connected to 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 present application, the valve repair device comprises: a spacer element, an inner clip assembly, a clip assembly, and an outer clip element; in another example embodiment of the present application, the valve repair device comprises: a spacer element, an inner clip assembly, a clip assembly, an outer clip element, an outer frame assembly, and a covering material.

The valve repair device can assume a plurality of states of transition during actual surgical application, such as an extended state, an open state, and a closed state; referring to fig. 2 to 4, fig. 2 is a schematic view showing an expanded state of the valve repair device of the present application in one embodiment, fig. 3 is a schematic view showing an opened state of the valve repair device of the present application in one embodiment, and fig. 4 is a schematic view showing a closed state of the valve repair device of the present application in one embodiment; as shown, the valve repair device 1 includes: a spacing element 11, an inner clamp component 12, a clamping component 13, an outer clamp component 14 and an outer frame component 15.

In the state shown in fig. 2, the valve repair device 1 is in an extended state, and the outer frame member and the covering material are not shown in fig. 2 for the convenience of showing the internal structure. The expanded state refers to a state when the spacer element 11 is farthest away from the distal end 143 of the outer clip element 14, and when the valve repair device 1 is in the expanded state, the components in the valve repair device 1 are, in order from the proximal end to the distal end, the spacer element 11, the inner clip component 12 (in this case, the clip component 13 is fixed to the inner clip component 12), and the outer clip element 14; in this state, the first hinge 113 is at a position closer to the proximal end than the second hinge 123; in the state shown in fig. 4, the spacer element 11, the inner clip assembly 12 and the clip assembly 13 are all folded to be held in the holding space of the outer clip element 14 when the valve repair device 1 is in the closed state, and in this state, the second hinge portion 123 is located at a position closer to the proximal end than the first hinge portion 113.

In the process of transforming the valve repair device 1 from the unfolded state to the closed state through an opened state, in which the spacing element 11 moves towards the distal end 143 of the outer frame component 14, the inner clip component 12 with greater rigidity is forced to move towards two sides by the linear motion of the spacing element 11 due to the first hinge 113 connecting the spacing element 11 and the inner clip component 12, and the outer clip component 14 with smaller rigidity is propped apart and deformed by the inner clip component 12 due to the second hinge 123 connecting the inner clip component 12 and the outer clip component 14, so that the whole valve repair device 1 presents a similar inverted umbrella-like structure in the state shown in fig. 3; the spacer element 11 is forced by the external force to continue to move towards the distal end 143 of the outer clamping element 14, when the less rigid outer clip member 14 is fully extended by the inner clip assembly 12, the first hinge 113 and the second hinge 123 are now at approximately the same height, as the spacer element 11 continues to move linearly toward the distal end 143 of the outer clamp element 14, the distal end of the spacer element 11 connected to the first hinge 113 and the proximal end of the inner clamp assembly 12 approach the distal end 143 of the outer clamp element 14, and the inner clamp assembly 12 is folded to move the proximal end thereof toward the distal end 143 of the outer clamp element 14, and the inner clamp assembly 12 is subjected to the elastic restoring force of the outer clamp arms of the outer clamp element 14, so as to force the inner clamp arms of the inner clamp assembly 12 to respectively abut against the two sides of the spacer element 11, and at this time, the valve repair device 1 is in the 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 to reduce or prevent regurgitation as described above. The spacer element may be blood impermeable and allow the native leaflets to close around the spacer element during ventricular systole to prevent blood from flowing back out of the left or right ventricle to the left or right atrium, respectively. The spacer element is sometimes referred to as a "coupling structure" in the applicant's earlier filed patent application, because its proximal end is used to connect to an external delivery device and its distal end is used to connect to an internal clamp assembly. In the present application, the spacer element may fill the space between the leaflets of a malfunctioning native mitral or tricuspid valve that does not close completely.

The spacer body of the spacer element has a first stiffness, defined as the overall stiffness of the spacer element, which in practice is moved by the force output by the drive shaft 20 of the delivery device, and which does not deform itself due to the design of its overall first stiffness when the drive shaft 20 drives the spacer element in movement relative to the distal end of the outer clamping element.

Referring to fig. 5 and 6, fig. 5 is a schematic exploded view of a spacer element according to an embodiment of the present disclosure, and fig. 6 is a schematic combined view of a spacer element according to an embodiment of the present disclosure, as shown in the drawings, in an embodiment, a proximal end of a spacing body 110 of a spacer element 11 has a connecting portion 111 for connecting a delivery device, and opposite sides of a distal end thereof have first hinge portions respectively; in an exemplary embodiment, the spacer element 11 includes a connecting head 112, a neck 114, a first spacer plate 115 and a second spacer plate 116 separated from the neck and extending distally, and hinge

structures

1131, 1132 respectively formed at the distal ends of the first spacer plate 115 and the second spacer plate 116, in order from the proximal end to the distal end, and specifically, the connecting head 112, the neck 114, the first spacer plate 115 and the second spacer plate 116, and the

hinge structures

1131, 1132 are integrally formed.

Referring back to fig. 4, in the embodiment shown in fig. 4, in a state where the spacing element 11, the clip assembly 13, and the inner clip assembly 12 are located in the clamping space, the connecting head of the spacing element 11 is higher than the height of 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 one of the clip assembly 13, the inner clip assembly 12, and the outer clip element 14 when the spacing element 11 is released.

In one embodiment, the valve repair device is implanted through a delivery catheter/sheath of a delivery device inserted through a septum into a left atrium and extending from the delivery sheath to assume an extended state, the valve repair device being partially opened to assume an inverted umbrella-like shape when delivered into a mitral valve at a location into a left ventricle, the valve repair device being fully closed to capture a native leaflet by operating clips on inner clip arms on both sides thereof to capture the native leaflet and then to clamp the native leaflet to achieve clamping thereof to the native mitral valve, the valve repair device being required to be separated from the delivery sheath after confirming that the valve repair device has completed clamping of the native mitral valve, the delivery sheath having a release structure thereon that is detachably coupled to the valve repair device to control coupling and decoupling of the delivery structure to and from the valve repair device, in the present embodiment, the releasing structure includes a driving shaft 20 (or referred to as a central core rod), a releasing control end, and a prosthetic control assembly; the far end of the middle core rod penetrates through the conveying pipe and then is detachably connected with the valve repair device, and the connection mode of the middle core rod and the valve repair device is one of threaded connection or clamping connection. 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, the release knob is fixed to an end of the proximal end of the central core rod, the central core rod is driven to rotate by rotating the release knob to achieve detachable connection or disconnection with the valve repair device, in order to prevent the release structure from being interfered or blocked 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 as to ensure that the release structure does not touch any of the clip assembly or the inner clip assembly or the outer clip element when being manipulated to move.

In the embodiment shown in fig. 5 and 6, the connecting portion 111 is fixed to the connecting head 112 of the spacer 11, and two opposite sides of the connecting portion 111 respectively have ear-shaped latches 1111 for engaging with the conveying device; the connecting portion 111 and the connecting head 112 are provided with a through hole 117 for the driving shaft 20 of the conveying device to pass through.

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

In the embodiment shown in fig. 5 and 6, the connecting portion 111 is fixedly connected to the connecting head 112 in an interference fit manner, two opposite sides of the connecting portion 111 are respectively provided with an ear-shaped latch 1111 for engaging with the release structure of the delivery device, and the connecting portion is detachably connected to an external delivery device through the ear-shaped latch 1111; correspondingly, the releasing structure (not shown) of the conveying device comprises two clamping pieces with clamping holes corresponding to the ear-shaped clamping block 1111, the clamping pieces have elasticity and are limited on the central core rod in a penetrating manner, after the central core rod is pulled away, the clamping pieces on the two sides are in a state of opening towards the two sides due to the fact that the elasticity of the clamping pieces is released, and then the purpose of separating the clamping holes on the clamping pieces from the ear-shaped clamping blocks is achieved, therefore, in order to avoid the situation that the clamping pieces are interfered or blocked when being released to open towards the two sides, the height of the connecting head of the spacing element is set to be higher than the height of each part of the clamping piece assembly or the inner clamping assembly or the outer clamping element (the height here refers to the height of each part of the valve repairing device in the closed state).

Referring to fig. 7, which is a schematic structural diagram of a spacer element in another embodiment of the present application, as shown in the exemplary embodiment of fig. 7, the height H of the connecting portion 111 on the connecting head of the spacer element 11 can be set by increasing the length of the neck portion 114 of the spacer element 11.

In one embodiment, each side of the connecting portion 111 of the spacer element 11 is provided with one ear-shaped fixture 1111, and accordingly, the release structure of the delivery device is provided with four corresponding fastening pieces for each ear-shaped fixture 1111, so as to ensure that the valve repair device is arranged on the delivery sheath of the delivery device in a more secure manner; alternatively, in another embodiment, the release structure of the delivery device is still two tabs with locking holes corresponding to the ear-shaped blocks 1111, so as to increase the success rate of the two tabs of the release structure capturing the connecting portion 111 of the spacer element 11 when the valve repair device needs to be captured after the release structure of the delivery device releases the valve repair device, and the two tabs of the release structure can capture the connecting portion by the ear-shaped blocks 1111 on either opposite side.

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

The connecting portion 111 and the connecting head 112 of the spacer element 11 are opened with a through hole 117 for passing the driving shaft 20 of the conveying device, so that the driving shaft 20 of the conveying device passes through the spacer element 11 until being coupled to the distal end of the outer clamping element, and accordingly, a gap for passing the driving shaft 20 of the conveying device is formed between the distal ends of the first partition plate 115 and the second partition plate 116 of the spacer element 11. In another embodiment, when the distal ends of the first and second partition plates of the partition element are combined with each other, a through hole for the driving shaft 20 of the conveying device to pass through is formed at the joint.

In an embodiment, the neck portion 114 of the spacer element 11 comprises a bridge structure 1141 separating the first and

second spacer plates

115, 116. The bridge structure 1141 includes a circular arc surface formed on an inner wall of a junction to separate the first and

second partition plates

115 and 116 by a predetermined distance. In this embodiment, the bridge structure 1141 forms a sealing end having a thickness greater than the thickness of the other portions (the first and second spacers 115 and 116). In this embodiment, the length of the sealed end is not less than 1/4 the entire length of the first or

second partition plate

115, 116. To avoid two ear-shaped fixture blocks 1111 (engaging ears) on the same side of the inner clamp assembly and the clip assembly from blocking the native/native valve leaflet from exiting after clamping it, the sealing end is designed to be longer, thereby increasing the distance between the ear-shaped fixture blocks 1111 and the inner clamp assembly and the clip assembly.

In the present embodiment, the neck 114 is a reinforcing structure, and specifically, the bridge structure 1141 separating the first spacer plate 115 and the second spacer plate 116 is designed to be thicker than the thickness of the first spacer plate 115 and the second spacer plate 116 to reinforce the rigidity of the neck 114; the first spacer plate 115 and the second spacer plate 116 extend distally from the bridge structure 1141 and begin to separate to form two sheets with a gap.

Referring to fig. 8, which is a side view of the spacer member of the present application in two directions according to an embodiment of the present application, as shown, the width W1 of the bridge structure 1141 in the first direction is greater than the maximum separation width W2 of the first spacer plate 115 and the second spacer plate 116; the second direction width W3 of the bridge structure 1141 is smaller than the maximum width W4 of the first partition plate 115 or the second partition plate 116, as shown in (a) and (b) of fig. 8; in the present embodiment, the first direction is defined as a transverse direction, the second direction is defined as a longitudinal direction, and the transverse width W1 of the bridge structure 1141 is greater than the maximum separation width W2 of the first and second partition plates 115 and 116; the bridge structure 1141 has a longitudinal width W3 smaller than the maximum width W4 of either the first or second partition plates 115, 116, and is designed to form a concave structure at the transition between the neck and the first and second partition plates 115, 116, which not only enhances the overall rigidity of the spacer element, but also forms a better sealing effect at the neck of the spacer element to facilitate the clip assembly, the inner clip assembly, and the outer clip assembly to more closely fit the faces of the first and second partition plates 115, 116 of the spacer element in the closed state, thereby effectively filling the space between the incompletely closed malfunctioning native mitral or tricuspid valves, thereby reducing or preventing regurgitation.

In one embodiment, the spacing element separates the first spacing plate 115 and the second spacing plate 116 via the bridge structure 1141 thereof, and the plate gap between the first spacing plate 115 and the second spacing plate 116 decreases from the bridge structure 1141 to the distal ends of the first spacing plate 115 and the second spacing plate 116, i.e. the plate gap adjacent to the bridge structure 1141 is larger than the plate gap at the distal ends of the first spacing plate 115 and the second spacing plate 116, as shown in fig. 8 (a). In this embodiment, the plate surface clearance of the distal ends of the first and

second spacing plates

115 and 116 is greater than or equal to the diameter of the drive shaft 20 of the conveying device, so that the drive shaft 20 passes through the spacing element to reach the distal end of the outer clamping element.

In some embodiments, the cross section of the first partition plate 115 or the second partition plate 116 may be semicircular, 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 an arc surface; or other cross-sectional shapes that facilitate the apposition function.

In an embodiment, the plate body of the first partition plate or the second partition plate has a decreasing width structure toward the hinge structure at the distal end thereof, in this embodiment, the plate body of the first partition plate or the second partition plate is not designed to have a uniform width, and the plate body adopts a decreasing width structure from the proximal end to the distal end, specifically, referring to fig. 9, which is a schematic structural view of the intermediate partition element in yet 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 extending to a certain length starts to contract inward, so that the plate body width thereof gradually narrows until the hinge part at the distal end, and accordingly, after the plate body of the second partition plate 116 is separated from the bridge structure 1141, one side edge (e.g. defined as a second side 1160) of the plate body extending to a certain length starts to contract inward, the width of the plate body of the spacer element is gradually narrowed until reaching the hinge part at the far end, so that a narrower hinge part or a hinge part with a shorter length can be obtained, and the mechanical friction force of the hinge part is further favorably reduced, so that the hinge connection of the spacer element 11 and the inner clamping component is more flexible; in the present embodiment, the plate body connected by the joint of the first hinge portion at the distal ends of the first partition plate 115 and the second partition plate 116 has a narrower width, so that the generated friction force is smaller, and when the driving shaft 20 drives the spacer element 11 to move towards the distal end of the outer clamping element to open the outer clamping arms of the outer clamping element, the driving shaft 20 needs a smaller pushing force, so that the inner clamping arms of the inner clamping assembly can more easily open the outer clamping arms of the outer clamping element.

According to the above description, a portion of the first side of the first partition plate 115 extends in a retraction trend, and a portion of the second side of the second partition plate 116 extends in a retraction 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 staggered with each other, thereby ensuring the balance of the stress on the first hinge portion.

In the embodiment shown in fig. 8, the spacer body of the spacer element has first hinges 113 on opposite sides of the distal end thereof; in an embodiment, the first hinge 113 of the first partition plate 115 and the first hinge of the second partition plate 116 have a maximum width W5 in the first direction that 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 at 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 spacer element 11 in the first direction, so that the width of the spacer element as a whole at the proximal end and the distal end is limited to facilitate that no larger radial space is occupied when the valve repair device is in the delivery catheter of the delivery device in which the delivery device is limited.

In the embodiment shown in fig. 8 (a), the outward curling of the hinge structure means curling in a direction away from the gap between the first partition plate 115 and the second partition plate 116, so that the axial center point of the first hinge portion is located outside the body of the partition element, thereby facilitating the hinging of the inner clip assembly, and when the inner clip assembly is hinged on the first hinge portion, the first inner clip arm and the second inner clip arm of the inner clip assembly cannot interfere with each other due to the distance of the outward curled hinge structures on both sides of the first partition plate 115 and the second partition plate 116.

In the embodiment shown in fig. 5, 6 or 8 (b), the plates of the first spacing plate 115 and the second spacing plate 116 of the spacing element are uniform-width plates, and the distal end of the first spacing plate 115 or the second spacing plate 116 forms a hinge structure as two separate 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 separate 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 first partition plate 115 and the second partition plate 116 of the partition element are non-uniform-width plates, a portion of the first side of the first partition plate 115 extends in a retracting trend, and a portion of the second side of the second partition plate 116 extends in a retracting trend, so that the hinge structures formed on the first partition plate 115 and the second partition plate 116 are staggered with each other, thereby ensuring the force balance of the hinge points on the two sides of the partition element.

In the present application, the inner clamp assembly is hinged at the distal end of the spacing element by means of a hinge, please refer to fig. 10, which shows an assembly schematic diagram of the inner clamp assembly in an embodiment of the present application, as shown in the figure, the inner clamp assembly includes a first inner clamp arm 121 and a second inner clamp arm 122, wherein a proximal end of the first inner clamp arm 121 is hinged at the first hinge portion of the first spacing plate 115, a proximal end of the second inner clamp arm 122 is hinged at the first hinge portion 113 of the second spacing plate 116, and the first inner clamp arm 121 and the second inner clamp arm 122 have the same rigidity, that is, the first inner clamp arm 121 has a second rigidity, and the second inner clamp arm 122 also has a second rigidity, in an embodiment, the second rigidity is smaller than or equal to the first rigidity, and in another embodiment, the second rigidity is larger than the first rigidity. In the present application, the second rigidity means that the acting force from the spacer element 11 and the outer clip element 14 is received at both the proximal end and the distal end of the first inner clip arm 121 or the second inner clip arm 122, and does not cause the deformation of the plate body of the first inner clip arm 121 or the second inner clip arm 122. 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 are made of nitinol or nitinol by laser cutting, and in order to ensure the rigidity distribution of the three, in this embodiment, the plate thickness of the first inner clip arm 121 or the second inner clip arm 122 is greater than that of the first spacer plate 115 or the second spacer plate 116 in the spacer element 11; the plate thickness of the first inner clip arm 121 or the second inner clip arm 122 is greater than the plate thickness of the first outer clip arm and the second outer clip arm in the outer clip element 14.

Referring to fig. 11, a schematic view of a first or second inner clamp arm according to an embodiment of the present invention is shown, wherein, in the embodiment, a proximal end of the first inner clamp arm 121 has an outwardly curled hinge structure 1231; the distal end of the first inner clip arm 121 has an inwardly curled hinge formation 1232, and correspondingly, the proximal end of the second inner clip arm 122 has an outwardly curled hinge formation 1231; the distal end of the second inner clamping arm 122 has a hinge structure 1232 curling inwards, and since the 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 the respective plate bodies, so that when the first inner clamping arm 121 and the second inner clamping arm 122 receive the thrust generated by the linear motion of the spacer element 11, the first inner clamping arm 121 and the second inner clamping arm 122 can transmit the force more efficiently, the thrust required by the driving shaft 20 of the conveying device is smaller, and then the two inner clamping arms of the inner clamping assembly can more easily open the two outer clamping arms of the outer clamping element 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 a predetermined strength, so that the clamping plate is not easily deformed when two ends of the clamping plate are stressed.

Referring to fig. 12, which is a schematic diagram illustrating an extended state of the valve repairing apparatus of the present application in another embodiment, as shown in the above-mentioned embodiment in which the plate bodies of the first partition plate 115 and the second partition plate 116 of the partition element 11 are non-uniform in width, in the embodiment in which the hinge structure 1131 of the first partition plate 115 and the hinge structure 1132 of the second partition plate 116 are staggered with each other, correspondingly, the hinge structure 1231 at the proximal end and the hinge structure 1232 at the distal end of the first inner clamping arm 121 or the second inner clamping arm 122 are staggered with each other along the plate body direction, so that the proximal ends of the first inner clamping arm 121 and the second inner clamping arm 122 are correspondingly hinged on the hinge portions 113 at the distal ends of the first partition plate 115 and the second partition plate 116, respectively. Due to the narrower hinge width of the connection at the intersection of the first hinge 113 and thus the lower 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 clamping element 14 to open the outer clamping arms of the outer clamping element 14.

In another embodiment, in which the first and

second partition plates

115 and 116 of the spacer element 11 are plate bodies with uniform width, and the hinge structures formed at the distal ends thereof are two separate hinge structures which are curled outward, the hinge structures at the proximal ends and the hinge structures at the distal ends of the first and second inner clamping

arms

121 and 122 are correspondingly aligned with each other along the plate body direction thereof, so that the proximal ends of the first and second inner clamping arms 122 of the inner clamping assembly are hinged between the two separate hinge structures which are curled outward, and the mutual alignment means that the hinge structures at the proximal ends and the hinge structures at the distal ends of the first and second inner clamping

arms

121 or 122 are disposed on the same central axis, thereby ensuring the stress balance of the hinge points.

In the present application, in the embodiments 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 clamp 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 near the proximal end of the first inner clamping arm 121 is provided with an opening 1211 for penetrating the first clamping piece 131, specifically, the opening 1211 is used for a part of the first clamping piece 131 to penetrate from one side surface (for example, the front surface) of the plate body of the first inner clamping arm 121 and be combined to the other side surface (for example, the back surface), correspondingly, a plate body near the proximal end of the second inner clamping arm 122 is provided with an opening for penetrating the second clamping piece 132, specifically, the opening is used for a part of the second clamping piece 132 to penetrate from one side surface (for example, the front surface) of the plate body of the second inner clamping arm 122 and be combined to the other side surface (for example, the back surface), in this embodiment, the plate body of the first inner clip arm 121 or the second inner clip arm 122 is provided with a fixing hole 1213 for welding or riveting the first clip 131 or the second clip 132. In this 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 respectively by welding, but not limited thereto, and in other embodiments, the first clamping piece 131 and the second clamping piece 132 may also be fixed on the first inner clamping arm 121 and the second inner clamping arm 122 respectively by rivet riveting or screw screwing.

In the embodiment shown in fig. 11, the first inner clamping arm 121 and the second inner clamping arm 122 have a stopper 1212 respectively on the plate body, the stopper 1212 is located at a position adjacent to the distal end of the plate body of the first inner clamping arm 121 and the second inner clamping arm 122, the stopper 1212 has a certain height, since the first clip 131 and the second clip 132 are respectively disposed on the first inner clamping arm 121 and the second inner clamping arm 122 in an opening and closing manner, as exemplified by the cooperation between the first clip 131 and the first inner clamping arm 121, when the first clip 131 is closed towards the first inner clamping arm 121 to be close to a surface (for example, a front surface) of the first inner clamping arm 121, since a side of the first clip 131 corresponding to the surface of the first inner clamping arm 121 has a barb, in order to ensure that the first clip 131 does not directly abut on the surface of the first inner clamping arm 121 to cause the barb to be pressed and deformed, a certain gap needs to be reserved between the first clip 131 and the first inner clamping arm 121, therefore, the height of the limiting block determines the relative distance between the first inner clamping arm 121 and the first clamping piece 131; accordingly, the second clip 132 mates with the second inner clip arm 122 in the same manner.

In embodiments, a gap between first jaw 131 and first inner jaw 121 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 3 mm.

In addition, since the first clip 131 and the second clip 132 are fixed on the plates of the first inner clip arm 121 and the second inner clip arm 122 by welding or riveting, as mentioned above, when fixing the first or the second clip on the plates of the first inner clip arm 121 and the second inner clip arm 122, it is necessary to ensure the positioning accuracy of the fixing positions of the two, the limiting block 1212 on the plates of the first inner clip arm 121 and the second inner clip arm 122 has the positioning function, so as to fix the first clip 131 on the first inner clip arm 121 for example, a part of the first clip 131 (for example, an elastic structure of a tongue piece on the first clip 131 in the following example) passes through the opening of the proximal end of the plate of the first inner clip arm 121 to the other side surface, and fixes the first clip 131 by welding or riveting, the barb on the first clip 131 and the limiting block 1212 are both located in the position space between the first clip 131 and the first inner clip arm 121, and then can through the barb on the first clamping piece 131 with this stopper 1212 relative position come judge first clamping piece 131 whether be positioned accurately, and then ensure that first clamping piece 131 fixes the ideal position at first interior arm lock 121 accurately, in actual operation, can with barb on the first clamping piece 131 supports and leans on the root in order to fix a position first clamping piece 131 in the ideal position of first interior arm lock 121.

Referring to fig. 13, which is a schematic view illustrating the combination of barbs and piercing holes on the clips and the inner clip arms according to an embodiment of the present invention, as shown in the figure, in an embodiment, a piercing hole or a piercing groove 1214 corresponding to the barb 1312 on the first clip 131 or the second clip 132 is formed on the plate body of the first inner clip arm 121 or the second inner clip arm 122, so that when the first clip 131 and the second clip 132 are clipped with the first inner clip arm 121 and the second inner clip arm 122, the barb on the first clip 131 or the second clip 132 can pierce into the piercing hole or the piercing groove, and still take the case that the first clip 131 is clipped with respect to the first inner clip arm 121 as an example to explain, in the case that a natural leaflet is captured between the first clip 131 and the first inner clip arm 121, after the barb or the barb on the first clip 131 pierces through the natural leaflet, it pierces into the piercing hole or the piercing groove on the plate body of the first inner clip arm 121, thereby more stably holding the natural leaflet between the first clip 131 and the first inner clip arm 121, the risk of the valve repair device falling off as the heart works is avoided.

Referring to fig. 10, as shown in the figure, the clip assembly 13 includes a first clip 131 and a second clip 132, the first clip 131 in the clip assembly has a fourth rigidity, and the second clip 132 also has a fourth rigidity, where the fourth rigidity is smaller than the third rigidity, that is, the first clip 131 and the second clip 132 have more flexible and elastic capability relative 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 piece 131 and the second clip piece 132 are integrally formed as a spring piece structure. In an embodiment, the first jaw 131 and the second jaw 132 are made from a sheet of shape memory alloy, such as by nitinol laser cutting.

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

Referring to fig. 14, which is a schematic view illustrating the expansion and closing of the clip assembly according to an embodiment of the present invention, as shown in the figure, in the embodiment, the first clip piece 131 is disposed on the first inner clip arm 121, and the distal end of the first clip piece 131 is respectively provided with a pulling portion 1313, specifically, the pulling portion 1313 is pulling

holes

1313, 1323 for passing a pulling wire. In one embodiment, the drawing hole 1313 is formed on the body of the first clip 131; in another embodiment, the pulling hole may be a through hole structure formed at the distal end of the first clip 131 and curling outwards, and the pulling hole 1313 of the first clip 131 is opened relative to the first inner clip arm 121 when being pulled by the pulling wire 30 (in the state of the first clip as shown in fig. 14), and correspondingly, when the pulling force is removed, the first clip 131 is closed relative to the first inner clip arm 121 due to its own elastic restoring force (in the state of the second clip as shown in fig. 14, the pulling force of the pulling wire is removed); correspondingly, the second clamping piece 132 is disposed on the second inner clamping arm 122, and the distal ends of the second clamping piece 132 are respectively provided with a pulling portion 1323, and specifically, the pulling portion 1323 is a pulling hole for passing the pulling wire 30. In one embodiment, the drawing hole is formed on the body of the second clip 132; in another embodiment, the drawing hole is a through hole structure formed at the distal end of the second clip 132 and curling outwards, and the drawing hole of the second clip 132 is opened relative to the second inner clip arm 122 when being drawn by the drawing wire 30, and correspondingly, the drawing force is removed, and the second clip 132 is closed relative to the second inner clip arm 122 due to its own elastic restoring force. In this embodiment, the opening angle of the first clip 131 or the second clip 132 relative to the first inner clip arm 121 or the second inner clip 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 wire control. In an embodiment, the pulling wire 30 (filament) may be further connected to a capturing ring 31, and the capturing ring 31 is connected to the pulling wire in the first jaw 131 and the second jaw 132 respectively. The pull wires 30 connected to the first clip 131 and the second clip 132 are commonly connected to the same capture ring 31 for retrieval of the valve repair device 1 of the present application. For example, if the valve repair device 1 is not well clamped, needs to be re-clamped or needs to be withdrawn for other reasons during later routine examination, the heart does not need to be opened, the snare is sent to the heart, the capture ring 31 is captured, after the capture is completed, the snare is pulled back, the first clamping piece 131 and the second clamping piece 132 are pulled up and opened, the captured native/natural valve leaflets are released again, the snare is pulled back continuously, and the valve repair device 1 is pulled back to the sheath tube to complete the recovery.

In an embodiment, the proximal end of the first clip 131 or the second clip 132 has an elastic structure, so as to provide an elastic restoring force to the first clip 131 or the second clip 132 when the pulling force from the pulling hole is eliminated, and in a specific implementation manner, the elastic structure may be implemented by one or more of cutting, reducing material, bending, and the like, of the clip body.

In an embodiment, a bending structure 1314 is formed adjacent to a proximal portion of the first or

second clip

131 or 132 to form a predetermined distance between a surface of the first or

second clip

131 or 132 and a surface of the first or second

inner clip arm

121 or 122. The bending structure 1314 also serves as an elastic structure to provide elastic restoring force for the clip, and is configured as shown in fig. 13.

In one embodiment, the elastic sheet body of the first clip 131 or the second clip 132 is a sheet body with a uniform width; in another embodiment, the elastic sheet body is a sheet body with different width distributions, please refer to fig. 15, which is a schematic view of a clip structure in another embodiment of the present application, as shown in the figure, 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 material of the sheet material, and the notch structures are symmetrical structures on the sheet body, so as to ensure the uniformity of the 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 invention, as shown in the drawings, the first clip 131 and the second clip 132 are fixed on the plates of the first inner clip arm 121 and the second inner clip arm 122 by welding or riveting, and in the above embodiment, the first clip 131 or the second clip 132 respectively includes an elastic plate 1310 having a hollow structure, a tongue piece 1311 extending from a proximal end of the elastic plate, and a barb 1312 formed on the elastic plate 1310. Specifically, the elastic sheet 1310, the tongue 1311, and the barb 1312 are integrally formed on the first clip 131 or the second clip 132, for example, by cutting, trimming, or punching. In some cases, the tongue 1311 may be a fixing piece.

Referring to fig. 17, which is a schematic view illustrating an assembly structure of a clip and an inner clip arm according to an embodiment of the present invention, as shown in the figure, a portion of the first clip 131 or the second clip 132 adjacent to the proximal end thereof has a tongue 1311 extending from the proximal end of the elastic sheet 1310, the tongue 1311 has a certain length, a portion of the tongue 1311 is welded or riveted to the first inner clip arm 121 or the second inner clip arm 122, and as still described by way of example, the first clip is fixed to the first inner clip arm 121, the tongue 1311 of the first clip passes through the opening 1211 of the first inner clip arm 121 and is bonded to the back surface of the first inner clip arm 121, and then the tongue 1311 is fixed to the back surface of the first inner clip arm 121 by way of welding or riveting, while a main portion (i.e., a portion having a barb) of the first clip 131 is still located on the front surface of the first inner clip arm 121, so that the first clip 131 is fixed to the first inner clip arm 121, because the tongue piece 1311 has a certain elastic force, it can fix the first clip 131 and also achieve the purpose of elastically combining the proximal end of the first clip 131 with the proximal end of the first inner clip arm 121, so that the first clip 131 can elastically close relative to the first inner clip arm 121; accordingly, the second clip 132 mates with the second inner clip arm 122 in the same manner.

In one embodiment, the barb 1312 of the first clip 131 or the second clip 132 is at an angle of 15 ° to 60 ° with respect to the flexible sheet 1310 thereof, and in this embodiment, the barb 1312 extends at an angle of 15 ° to 60 ° towards the proximal end of the first clip 131 or the second clip 132, and in particular, in some embodiments, the 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 leaflets can be disengaged when the first or

second clip

131, 132 is pulled.

In embodiments, the barb 1312 in the first jaw 131 or the second jaw 132 has a length of 0.3-3mm, and in particular, in some embodiments, the barb 1312 has a length of 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 3 mm.

Referring to fig. 18, which shows a schematic view of the barb structure on the clip of the present application in another embodiment, as shown in the drawings, the width of the root portion of the barb in the first clip 131 or the second clip 132 is smaller than the middle width thereof, i.e., each barb 131 extends from the elastic sheet body at the above-mentioned inclination angle, the root portion 13121 has a narrower width, then the width increases gradually to transition to the middle portion 13122, and then the width decreases gradually until a sharper needle point 13123 is formed, so that the barb 1312 formed in the above-mentioned structure can better hold the natural 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 piercing the natural leaflet.

In one embodiment, the resilient body of the first clip 131 or the second clip 132 has a set of barbs, including 3 barbs or 4 barbs 1312, arranged adjacent to the distal portion of the first clip 131 or the second clip 132; in another embodiment, such as the embodiment shown in fig. 13-18, the barbs 1312 on the first jaw 131 or the second jaw 132 are in multiple sets, wherein the number of barbs 1312 on one set is greater than the number of barbs 1312 on the other set, such as 3 or 4 barbs on the one set and 1 or 2 barbs on the other set.

In one embodiment, when there are multiple sets of barbs on the first clip piece 131 or the second clip piece 132, the barbs in each set may be arranged at regular intervals, for example, at regular fixed intervals or at intervals with gradually changing differences; in one embodiment, the plurality of sets of barbs may be arranged in a staggered manner, such as a staggered manner with the positions of the barbs being staggered one after the other.

In one embodiment, the first clip 131 or the second clip 132 is a double-layer spring (not shown) including an inner layer spring and an outer layer spring, the inner layer spring is provided with an agnail, the outer layer spring is attached to the inner layer spring to reinforce the elasticity or clamping force of the clamping piece, and the inner layer spring and the outer layer spring are combined at the proximal end. In this embodiment, the inner layer elastic sheet and the outer layer elastic sheet may be welded or riveted at the proximal end, or the inner layer elastic sheet and the outer layer elastic sheet are integrally formed, and the inner layer elastic sheet and the outer layer elastic sheet are combined at the proximal end portion in a bending manner.

Taking the first clip 131 as an example, the first clip 131 has a double-layer spring structure, which includes an inner layer spring and an outer layer spring, wherein, in order to increase the elastic capacity of the outer layer elastic sheet, the outer layer elastic sheet can be a hollow structure, the inner elastic sheet is provided with an elastic sheet body with a hollow structure, a tongue piece extending from the near end of the elastic sheet body and an agnail formed on the elastic sheet body, wherein, the first clip 131 with 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 near end of the elastic sheet body on the inner clip, in this embodiment, the distal end of the first clip 131, which is a double-layer clip structure, has a drawing hole, specifically, the corresponding positions of the inner layer elastic sheet and the outer layer elastic sheet are provided with traction holes for the traction wires to pass through, so that the first jaw 131 is forced to open with respect to the first inner jaw 121 by a pulling force. Accordingly, the double-layer spring structure of the second clip 132 and the configuration thereof are also the same.

In the present application, the outer clip element 14 is an integrally formed component, in the embodiment shown in fig. 2 or fig. 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 portion 143 at which the first outer clip arm 141 and the second outer clip arm 142 are integrally joined at a distal end, and a hinge portion 123 formed at a proximal end of the first outer clip arm 141 and the second outer clip arm 142, respectively. The first outer clip arm 141 has a third rigidity, and the second outer clip arm 142 also has the same third rigidity, in this application, the rigidity of the whole of the first outer clip arm 141 or the second outer clip arm 142 is defined as the third rigidity, and the rigidity distribution of the first outer clip arm 141 or the second outer clip arm 142 adjacent to the proximal end portion is smaller than the rigidity distribution adjacent to the distal end portion. A clamping space is formed between the first outer clamping arm 141 and the second outer clamping arm 142, and when the spacer element 11, the clip assembly 13, and the inner clamping assembly 12 are located in the clamping space, the first outer clamping arm 141 and the second outer clamping arm 142 maintain opposite clamping forces.

In some embodiments, the outer clip element 14 may also be referred to as a U-shaped structure surrounded by two assistant force plates, and the first outer clip arm 141 or the second outer clip arm 142 of the outer clip element 14 may also be referred to as a clip strip.

Referring to fig. 19 in conjunction with fig. 2 to 4, fig. 19 is a schematic view illustrating a state of clamping an outer clamping element according to an embodiment of the present application, as shown in the drawings, the outer clamping element 14 includes a distal end 143, and a first outer clamping arm 141 and a second outer clamping arm 142 which are integrally formed with the distal end 143 and respectively have a third rigidity; the proximal ends of the first outer clamping arm 141 and the second outer clamping arm 142 are respectively hinged to the second hinge part 123; in this embodiment, 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 that are curled outward, and is used to hinge the second hinge portion 123 at the distal ends of the first inner clip arm 121 and the second inner clip arm 122 of the inner clip assembly, so that when the first inner clip arm 121 and the second inner clip arm 122 of the inner clip assembly are moved downward by the spacer element 11 to open to both sides respectively to open the first inner clip arm 121 and the second inner clip arm 122 to both sides through the hinge movement of the second hinge portion 123, and when the spacer element 11 continues to move downward to cause the first inner clip arm 121 and the second inner clip arm 122 to generate inward clipping, the first outer clip arm 141 and the second outer clip arm 142 are clipped by their own elastic force, and thus the spacer element 11, the clip assembly 13, and the inner clip assembly 12 are located in the clipping space, and the elastic force of the first and second outer clamping arms 141 and 142 keeps the components/elements in the clamping space facing each other.

In the embodiment shown in fig. 2 or 3 and fig. 19, the width of the proximal end and the distal end 143 of the first outer clip arm 141 or the second outer clip arm 142 is the same, that is, the first outer clip arm 141 and the second outer clip arm 142 are both plates with the same width, 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 adjacent to the distal end, the first outer clip arm 141 or the second outer clip arm 142 has a structure with a thickness increasing from the proximal end toward the distal end 143, as shown in fig. 19, the thickness of the plate body adjacent to the proximal end of the first outer clip arm 141 or the second outer clip arm 142 is d1, the thickness of the plate body adjacent to the distal end 143 of the first outer clip arm 141 or the second outer clip arm 142 is d2, the thickness d1 < the thickness d2, so that the proximal end of the first outer clip arm 141 or the second outer clip arm 142 has a greater elastic capacity, accordingly, the elastic capacity of a portion of the first or second outer clip arm 141 or 142 adjacent to the distal end 143 thereof is relatively weak. In the present application, the stiffness distribution of the first outer clip arm 141 or the second outer clip arm 142 including the proximal portion and the distal end 143 is gradual rather than abrupt.

In the embodiment where the first or second

outer clamping arm

141 or 142 is a plate with the same width, the hinge structure formed at the proximal end of the first or second

outer clamping arm

141 or 142 is two separate and outwardly curled

hinge structures

1410, 1420, so that the

distal hinge structure

1231 or 1232 of the first or second

inner clamping arm

121 or 122 is hinged between the two separate and outwardly curled

hinge structures

1410, 1420, thereby forming a hinge with stable pivoting, and ensuring the force balance of the hinge point.

In an embodiment, the width of the first or second

outer clamping arm

141 or 142 is greater than the width of the first or second

inner clamping arm

121 or 122, and the width of the first or second

outer clamping arm

141 or 142 is greater than the width of the first or

second clip

131 or 132, so as to shield the spacer element 11, the inner clip assembly, and the clip assembly when the outer clip element 14 is folded to clamp them in the clamping space.

Referring to fig. 20, which is a schematic structural diagram of an outer clip element according to an embodiment of the present invention, as shown in the figure, a hinge structure formed at a proximal end 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 end of the first outer clip arm 141 or the second outer clip arm 142 is correspondingly hinged to the second hinge portion 123 at the distal end of the first inner clip arm 121 and the second inner clip arm 122, respectively (for convenience of understanding, only one side of the inner clip arm and the clip are shown in fig. 20). Due to the narrow hinge width at the joint of the second hinge 123, the generated friction is small, and when the driving shaft 20 drives the spacer element 11 to move towards the distal end 143 of the outer clamping element 14 to open the two inner clamping arms of the inner clamping element, the two inner clamping arms spread apart the first outer clamping arm 141 and the second outer clamping arm 142, the small friction at the hinge does not affect the force application of the two inner clamping arms. As shown in fig. 12, the widths of the proximal end and the distal end 143 of the first outer clamping arm 141 or the second outer clamping arm 142 are different, that is, the first outer clamping arm 141 and the second outer clamping arm 142 are plates with different widths, specifically, taking the first outer clamping arm 141 as an example, the first outer clamping arm 141 presents a structure with a decreasing width from the distal end 143 toward the proximal end thereof, and correspondingly, the second outer clamping arm 142 also has the same structure. As shown in fig. 21, fig. 21 is a schematic view of a valve repair device according to another embodiment of the present application.

Referring to fig. 22, which is a side view of the outer clip element in an embodiment of the present invention, as shown in the figure, 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 projected point o of the

hinge structures

1410 and 1420 at the proximal end of the first outer clip arm 141 or the second outer clip arm 142 is located at the outer side of the first outer clip arm 141 or the second outer clip arm 142 (as shown by the dotted line in fig. 19), 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, the axis of the curl is located at the outer side of the projected of the first outer clip arm 141, so that the second hinge portion 123 has a better force application 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, a smaller force is required when the first inner clamp arm 121 and the second inner clamp arm 122 support the first outer clamp arm 141 and the second outer clamp arm 142.

In the embodiment shown in fig. 22, the first and second

outer clip arms

141 and 142 respectively include a first curved section a, a second curved section b, and a third curved section c extending from the distal end 143 toward the proximal ends thereof; wherein, the maximum distance w1 between the first bending sections a of the first and second outer clamping

arms

141 and 142 is smaller than the maximum distance w2 between the second bending sections b; the maximum distance w1 between the first bending sections a of the first and second outer clamping

arms

141 and 142 is greater than or equal to the minimum distance w3 between the third bending sections c, i.e., w3 is not less than w1 and not more than w 2.

Referring to fig. 23, which is a side view of the outer clip element in another embodiment of the present invention, as shown in the drawing, in this embodiment, the outer clip element 14 is a U-shaped member, the first outer clip arm 141 and the second outer clip arm 142 respectively include a first curved section a, a second curved section b, and a third curved section c extending from the distal end 143 toward the proximal end thereof, in this embodiment, the maximum distance between the first curved sections a of the first outer clip arm 141 and the second outer clip arm 142 is w1, the 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 the minimum distance between the third curved sections c of the first outer clip arm 141 and the second outer clip arm 142 is w3, i.e., w3 ≦ w1 < w 2. The embodiments for realizing the above-mentioned spacing relationship are two structures as shown in fig. 22 and 23, namely, a manner that a 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 is located at the outer side of the first outer clamping arm 141 or the second outer clamping arm 142, and a manner that a 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 is located at the inner side of the first outer clamping arm 141 or the second outer clamping arm 142.

In the embodiment shown in fig. 23, in order to increase the opposite clamping force of the first and second outer clamping

arms

141 and 142 in the normal state, the clamping space formed by the first and second outer clamping

arms

141 and 142 has a smaller opening, i.e., the projection o of the hinge structure at the proximal end of the first or second

outer clamping arm

141 or 142 falls on the inner side of the first or second

outer clamping arm

141 or 142 and falls in the clamping space; in the present embodiment, a larger force is required when the first inner clip arm 121 and the second inner clip arm 122 support the first outer clip arm 141 and the second outer clip arm 142.

Referring to fig. 24, which is a side view of an outer clip element according to yet another embodiment of the present invention, as shown, in this embodiment, 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 and second

outer clip arms

141 and 142 is w1, and the maximum distance between the straight sections d of the first and second

outer clip arms

141 and 142 is also w1, as shown in fig. 24.

Referring to fig. 25, which is a schematic view illustrating the cooperation of the outer clip element and the driving shaft according to an embodiment of the present invention, as shown in the drawings, the first outer clip arm 141 and the second outer clip arm 142 of the outer clip element 14 are integrated at the distal end 143, 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 connecting portion of the spacer element 11 and the gap between the first partition plate 115 and the second partition plate 116 and is screwed into the screw hole 1431 of the distal end 143, when the driving shaft 20 is contracted proximally, the spacer element 11 is driven to move linearly relative to the distal end 143, and the first inner clip arm 121 and the second inner clip arm 122 hinged to the first hinge portion 113 are driven by the spacer element 11 to expand, and the first outer clip arm 141 and the second inner clip arm 142 hinged to the second hinge portion 123 are supported by the first inner clip arm 121 and the second inner clip arm 122 When the first outer clip arm 141 and the second outer clip arm 142 with smaller rigidity are expanded to the maximum, the distal end of the spacer element 11 connected with the first hinge portion 113 and the proximal ends of the first inner clip arm 121 and the second inner clip arm 122 approach the distal end 143 of the outer frame assembly, at this time, the first inner clip arm 121 and the second inner clip arm 122 are folded to make the proximal ends thereof approach the distal end 143 of the outer clip element 14, the first outer clip arm 141 and the second outer clip arm 142 force the first inner clip arm 122 and the second inner clip arm 122 on both sides of the inner clip assembly to respectively abut on both sides of the spacer element 11 due to the elastic restoring force, and at this time, the valve repairing device is in the closed state, that is, the state shown in fig. 25. After this operation, the drive shaft 20 of the delivery device is rotated out of the threaded bore 1431 so that the drive shaft 20 is withdrawn into the valve repair device.

Referring to fig. 26, there is shown a schematic structural view of an outer clip element in a further embodiment of the present application, as shown, in this embodiment, the distal end 143 of the outer clip element 14 is an arc-shaped thickened structure or a base structure integrally formed at the bottom thereof.

In one embodiment, the distal end 143 of the outer clamping member 14 is provided with a shaft hole 1432 at each side. In this embodiment, two sides of the distal end 143 of the outer clamping element 14 are two sides in the second direction, and two shaft holes 1432 are provided on the two sides for coupling the outer frame assembly, so that the two outer frame assemblies are rotatably coupled to two sides of the distal end 143 of the outer clamping element 14.

In some embodiments, the outer clamping member 14 has a shaft hole 1432 or a side through slot on two sides of the distal end 143.

Referring to fig. 27, which is a schematic view illustrating a configuration of an outer frame assembly in a valve repairing apparatus according to an embodiment of the present disclosure, as shown in the figure, in the embodiment, the valve repairing apparatus 1 further includes an outer frame assembly 15 for covering a covering material, the outer frame assembly 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 frame structures formed by bending strip-shaped members, 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 clamping element 14, so as to respectively cover the first outer clamping arm 141 or the second outer clamping arm 142 in a closed state.

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

Please refer to fig. 28, which is a schematic diagram illustrating an outer frame structure of an outer frame assembly according to an embodiment of the present invention, and for easy understanding, fig. 28 provides three views, wherein fig. 28 (a) is a perspective view of the outer frame structure, fig. 28 (b) is a front view of the outer frame structure, and fig. 28 (c) is a schematic diagram illustrating a state where the first and second outer frames are folded, as shown in the figure, in this embodiment, the first outer frame 151 or the second outer frame 152 is folded to have a leaflet structure, and it should be understood that the folding to have the leaflet structure means that the folding structure of the first outer frame 151 or the second outer frame 152 presents a structure similar to a petal or a plant leaf after being wrapped by a covering object.

As shown in fig. 28, taking the first external frame 151 as an example, the first external frame 151 formed by a strip member includes a first section L1 extending in the second direction for a first length, a second section L2 extending in the third direction for a second length, a third section L3 bending in an inside-out shape for a third length, a fourth section L4 extending in the second direction for a fourth length, a fifth section L5 bending in an inside-out shape for a third length, a sixth section L6 extending in the third direction for a second length, and a seventh section L7 extending in the second direction for a first length, wherein the first section L1 has a length equal to that of the seventh section L7, the second section L2 has a length equal to that of the sixth section L6, the third section L3 has a length equal to that of the fifth section L5, the first section L1 and the seventh section L7 are coupled to the shaft holes at both sides of the shaft hole 143 of the external clip element 14, and the third section L2, the fourth section L73742, the fourth section L3527, the third section L3523, and the first section L6336 are coupled to the shaft hole of the shaft hole 143, The fifth section L5 and the sixth section L6 form a frame structure extending from the axial connection portion toward the proximal end and increasing in width, and the third section 3 and the fifth section L5 are outer curved structures formed on the proximal end side of the frame structure.

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

In an embodiment, when the first and second

outer frames

151 and 152 of the outer frame assembly cover the first and second

outer clip arms

141 and 142 in the closed state, a gap between the middle portions of the first and second

outer frames

151 and 152 is not greater than 3mm, and preferably, the gap between the middle portions of the first and second

outer frames

151 and 152 is between 1mm and 3 mm.

Referring to fig. 29 and 30, fig. 29 is a schematic view of a closed state of a valve repair device covered with a covering material according to an embodiment of the present invention, and fig. 30 is a schematic view of an open state of the valve repair device covered with a covering material according to an embodiment of the present invention, as shown in the drawings, in the present embodiment, the valve repair device 1 further includes a covering material 16 for covering the spacing element 11, the inner clip assembly 12, the clip assembly 13, the outer clip assembly 14, and the outer frame assembly 15, and in an embodiment, the covering 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 where the valve repair device is closed after capturing and holding the native leaflets, the majority of the held native leaflets will be covered 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, velvet, or other suitable woven material. In other embodiments, the cover material 16 may include a coating, such as a polymer (e.g., natural polymer), 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 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 a fine mesh polyethylene cloth, the cloth covering may provide a blood seal over the spacer surface and/or promote rapid tissue ingrowth.

Referring to fig. 31, which is a schematic view of an open state of a valve repair device of the present application covered with a covering material, in this embodiment, as shown in the drawings, the covering material 16 covered on the spacer elements 11 and the clip assembly 13 is a one-piece woven material; the inner clip component 12, the outer clip element 14 and the outer frame component 15 are integrally woven. Wherein barbs on the clip assembly 13 are exposed through the covering material 16 to capture the valve. In other words, in the valve repair device, two parts of independent braiding are included, wherein the first and

second clips

131 and 132 of the spacer element 11 and clip assembly 13 are wrapped by one piece of braid, and the first and second

inner clamp arms

121 and 122 of the inner clamp assembly 12, the first and second

outer clamp arms

141, 142 and distal ends 143 of the outer clamp element 14, and the first and second

outer frames

151 and 152 of the outer frame assembly 15 are wrapped by another piece of braid, so that the parts of the valve repair device have more tensile and fatigue resistance.

In this application, the term "integrally knitted" means that a portion of the knitted fabric is continuous and uninterrupted, for example, the knitted material covered on the inner clip member 12, the outer clip member 14, and the outer frame member 15 is integrally knitted, that is, the inner clip member 12, the outer clip member 14, and the outer frame member 15 are covered by a single piece or a whole piece of knitted fabric, so that the knitted fabric can not only improve the sealing effect of the covering of the inner wrapped member, but also provide the wrapped portions with more tensile and fatigue resistance.

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 by the covering material 16, and a wrapping space presented by the leaflet structure can wrap the first outer clip arm 141 or the second outer clip arm 142 therein, thereby having an effect of shielding the first outer clip arm 141 or the second outer clip arm 142. In this embodiment, the first outer frame 151 and the first outer clip arms 141 are wrapped together by the covering material 16 to integrate the first outer frame 151 and the first outer clip arms 141, and the second outer frame 152 and the second outer clip arms 142 are wrapped together by the covering material 16 to integrate the second outer frame 152 and the second outer clip arms 142.

In the embodiment, in the state that the first inner clamping arm 121 and the second inner clamping arm 122 of the inner clamp assembly 12 are wrapped by the covering material 16, the tongue piece of the first clip 131 and the tongue piece of the second clip 132 fixed on the first inner clamping arm 121 and the second inner clamping arm 122 are also wrapped together, so that the tongue pieces of the first inner clamping arm 121 and the first clip 131 are wrapped together and integrated into a whole, and the tongue pieces of the second inner clamping arm 122 and the second clip 132 are wrapped together and integrated into a whole.

In the embodiment, in the state that the spacing element 11 is wrapped by the covering material 16, the lug-shaped block on the connecting part of the spacing element for clamping the release structure in the conveying device leaks out of the covering material 16 so as to be clamped with the release structure. In this embodiment, the first spacer plate 115 and the second spacer plate 116 of the spacer element 11 are integrally wrapped by the covering material 16, and the gap therebetween is concealed by the covering material 16.

In another embodiment, the valve repair device 1 further comprises a cover material 16 for enclosing 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 a one-piece woven material; the woven material that wraps the inner and

outer clamp members

12, 14 is integrally woven.

To further illustrate the inventive concepts and principles of the present application, and referring to fig. 2-4, the valve repair device 1 can assume a plurality of states, such as an extended state, an open state, and a closed state, during actual surgical applications; when the valve repair device 1 is deployed in the delivery catheter/sheath of a delivery device, which is inserted into the left atrium through the septum, it is constrained in its extended state, and the valve repair device 1 is extended from the delivery sheath to assume its extended state, in which the connection portion at the proximal end of the spacer element 11 is snap-connected to the distal end of the delivery catheter/sheath, the first inner clipping arm 121 and the second inner clipping arm 122 hinged to the first hinge portion 113 at the distal end of the spacer element 11 are in a nearly fitted state, and the first outer clipping arm 141 and the second outer clipping arm 142 of the outer clipping element 14 hinged to the first hinge portion 113 at the distal end of the first inner clipping arm 121 and the second inner clipping arm 122, respectively, are in a normally U-shaped configuration due to being out of the constraint of the inner space of the delivery catheter/sheath.

The valve repair device 1 is delivered to the mitral valve position into the left ventricle and is partially opened to assume an inverted umbrella-like shape so that when the native valve leaflets are captured by operating the jaws on the inner clip arms on both sides thereof, the first clip 131 or the second clip 132 is opened relative to the first inner clip arm 121 or the second inner clip arm 122 by operating the pull wire passing through the distal ends of the first clip 131 or the second clip 132, at which time the spacer element 11 is moved toward the distal end 143 of the outer clip element 14 (it can also be understood that the distal end 143 of the outer clip element 14 is moved toward the spacer element 11) by operating the drive shaft 20 (central rod) of the delivery device, the first inner clip arm 121 and the second inner clip arm 122 hinged to the first hinge 113 are simultaneously opened to both sides (outside) due to the pivoting axis or pivoting structure provided by the first hinge 113, accordingly, the first and second jaws 131 and 132 fixed to the first and second inner clamp arms 121 and 122, respectively, also open to both sides (outside) simultaneously with the first and second inner clamp arms 121 and 122, and the first and second outer clamp arms 141 and 142 are gradually opened up to the maximum opening range due to the rotation axis or pivot provided by the U-shaped first and second outer clamp arms 141 and 142 at the second hinge portion 123 and the stiffness (third stiffness) of the first and second outer clamp arms 141 and 142. The valve repair device 1 now assumes an open state resembling an umbrella.

By further moving the spacer element 11 towards the distal end 143 of the outer clip 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 clamping space formed by the first outer clip arm 141 and the second outer clip arm 142 of the U-shaped configuration and gradually approaches the distal end 143 of the outer clip element 14, at which time the proximal and distal ends of the first inner clip arm 121 and the second inner clip arm 122, one end of which is hinged to the first hinge portion 113 and the other end of which is hinged to the second hinge portion 123, are interchanged, during which the first clip arm 131 and the second clip arm 132 are released by controlling the pull wire so that the one-side natural valve is clamped between the first clip arm 131 and the first inner clip arm 121 and the other-side natural valve is clamped between the second clip arm 132 and the second inner clip arm 122, further downward movement of the spacer element 11 causes the first inner clip arm 121 and the second inner clip arm 122 to be inwardly (towards the central axis of the spacer element 11), at this time, due to the turning of the first inner clamping arm 121 and the second inner clamping arm 122, the supporting force for the first outer clamping arm 141 and the second outer clamping arm 142 is reduced, the first outer clamping arm 141 and the second outer clamping arm 142 are clamped in opposite directions by the elastic restoring force of the first outer clamping arm 141 and the second outer clamping arm 142, so that the spacer element 11, the clip element 13, and the inner clip element 12 are located in the clamping space, and the elastic force of the first outer clamping arm 141 and the second outer clamping arm 142 keeps in opposite directions the clamping force for each element/element in the clamping space, so that the valve repairing device 1 is in the closed state.

At this point, partial closure of the native valve is accomplished by disengaging the drive shaft 20 of the delivery device from the threaded bore 1431 of the outer clip element 14, and then withdrawing the drive shaft 20 to release the engagement of the ear-shaped catches on the spacer element 11 and the pull wires from the pull holes of the first and

second clips

131, 132 by manipulating the release structure at the distal end of the delivery catheter/sheath of the delivery device.

The valve repair device provided by the application adopts two hinge structures to respectively hinge the spacing element and the inner clamping assembly at the first position and hinge the inner clamping assembly and the outer clamping element in a U-shaped structure at the second position, and the two hinge structures have better flexibility compared with the prior art (such as the valve repair clamp disclosed in Chinese patent publication No. CN 111449805A) in which only one hinge structure is adopted at one position and the other hinge structure is adopted at the other position, so that the valve repair device requires smaller force when the driving shaft drives the spacing element to move towards the distal end part of the outer clamping element, and is further beneficial to the precision control of a doctor during operation; furthermore, the present application adopts the integrally formed U-shaped outer clip element, and the rigidity of the outer clip arm is designed to continuously maintain the opposite clamping force for each component/element in the clamping space, which has more stable performance compared to the related art in which a mechanical lock is used to ensure the clamping effect, and the present application adopts the integrally formed U-shaped outer clip element to provide a simpler clamping manner in structure, and has more stable clamping effect compared to the related art in which an elastic clamping force is provided by the frame/bar element, and has a simpler preparation process compared to the prior art in which the outer and inner clip arms formed by folding the metal woven material (for example, the woven mesh valve repair clamp disclosed in chinese patent publication No. CN 112402061A).

The above embodiments are merely illustrative of the principles and utilities of the present application and are not intended to limit the application. Any person skilled in the art can modify or change the above-described embodiments without departing from the spirit and scope of the present application. Accordingly, it is intended that all equivalent modifications or changes which can be made by those skilled in the art without departing from the spirit and technical concepts disclosed in the present application shall be covered by the claims of the present application.

Claims

1. A valve repair device, comprising:

the spacer element is provided with a connecting part used for connecting a conveying device at the proximal end, and the two opposite sides of the distal end are respectively provided with a first hinge part;

the inner clamp assembly comprises a first inner clamp arm and a second inner clamp arm, and the near ends of the first inner clamp arm and the second inner clamp arm are respectively hinged to the first hinge part; the far ends of the first inner clamping arm and the second inner clamping arm are respectively provided with a second hinge part;

the clamping piece assembly is arranged on the inner clamping assembly or hinged to the first hinged part and comprises a first clamping piece capable of opening or closing relative to the first inner clamping arm and a second clamping piece capable of opening or closing relative to the second inner clamping arm, and the far 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 and first and second outer clip arms integrally formed with the distal end; the near ends of the first outer clamping arm and the second outer clamping arm are respectively hinged to the second hinge part; and 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 the state that the spacing element, the clamping piece assembly and the inner clamping assembly are positioned in the clamping space.

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

3. The valve repair device of claim 2, wherein the connector head is higher than a height of the clip assembly or inner clip assembly or outer clip element with the spacer element, clip assembly, and inner clip assembly in the clamping space.

4. The valve repair device of claim 2, wherein the connector of the spacer element is fixed with the connecting portion, and the connecting portion has ear-shaped retainers on opposite sides thereof for retaining the delivery device; the connecting part and the connector are provided with through holes for the driving shaft of the conveying device to pass through.

5. The valve repair device of claim 4, wherein the ear-shaped fixture blocks at two sides of the connecting portion extend in a direction parallel to the plate surfaces of the first and second partition plates.

6. The valve repair device of claim 2, wherein the neck portion includes a bridge structure separating the first and second spacer plates, the bridge structure having a width in a first direction greater than a maximum separation width of the first and second spacer plates; the width of the bridge structure in the second direction is smaller than the maximum width of the first partition plate or the second partition plate.

7. The valve repair device of claim 2, wherein the distal ends of the first and second spacer plates have a gap therebetween through which a drive shaft of the delivery device passes.

8. The valve repair device of claim 2, wherein the distal ends of the first and second spacers are joined to each other and have a through hole formed at the joint for passing a drive shaft of the delivery device therethrough.

9. The valve repair device of claim 2, wherein the distal end of the first or second spacer plate forms a hinge structure that is two separate and outwardly curled hinge structures.

10. The valve repair device of claim 2, wherein the hinge structure formed at the distal end of the first spacer plate or the second spacer plate is an outwardly curled hinge structure, wherein the hinge structure of the first spacer plate and the hinge structure of the second spacer plate are offset from each other.

11. The valve repair device of claim 2, wherein the first hinge portion of the first spacer plate and the first hinge portion of the second spacer plate have a maximum width in the first direction that is no greater than a maximum width of the connecting portion of the spacer element in the first direction.

12. The valve repair device of claim 2, wherein the plate body of the first or second spacer plate has a decreasing width toward the hinge structure at the distal end thereof.

13. The valve repair device of claim 2, wherein a plate thickness of the first or second inner clamp arm is greater than a plate thickness of the first or second spacer plate; the plate thickness of the first inner clamping arm or the second inner clamping arm is larger than that of the first outer clamping arm and the second outer clamping arm.

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

15. The valve repair device of claim 1, wherein the hinge structure at the proximal end and the hinge structure at the distal end of the first or second inner clamp arm are offset from each other in the direction of the plate body thereof; or the hinge structure at the near end and the hinge structure at the far end of the first inner clamping arm or the second inner clamping arm are mutually aligned along the plate body direction.

16. The valve repair device of claim 1, wherein the plate body adjacent the proximal end of the first or second inner clamp arm has an opening therethrough for receiving the first or second clip such that a portion of the first or second clip extends through the opening from one side of the plate body and is bonded to the other side.

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

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

19. The valve repair device of claim 1, wherein the plate body of the first or second inner clamp arm is provided with a puncture hole or a puncture groove corresponding to the barb of the first or second clamp arm.

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

21. The valve repair device of claim 1, wherein the first clip or the second clip is a double-layer spring that includes an inner layer spring and an outer layer spring, the inner layer spring having barbs thereon, the outer layer spring being attached to the inner layer spring, the inner layer spring and the outer layer spring being joined at a proximal end.

22. The valve repair device of claim 21, wherein the outer spring is a hollow structure.

23. The valve repair device of claim 1, wherein the outer clip element is a U-shaped element, and distal ends of the first or second outer clip arms are integral at distal ends of the U-shaped element.

24. The valve repair device of claim 1, wherein the hinge structure formed by the proximal ends of the first or second outer clamp arms is two separate and outwardly curled hinge structures.

25. The valve repair device of claim 1, wherein the proximal end and the distal end of the first or second outer clip arm are the same width.

26. The valve repair device of claim 1, wherein the hinge structure formed at the proximal end of the first or second outer clamp arm is an outwardly curled hinge structure, and the hinge structures of the first and second outer clamp arms are offset from each other.

27. The valve repair device of claim 1, wherein the first or second outer clamp arm is configured to increase in width from the proximal end toward the distal end.

28. The valve repair device of claim 1, wherein a projected point of the hinge structure at the proximal end of the first or second outer clamp arm falls outside of the first or second outer clamp arm.

29. The valve repair device of claim 1, wherein the first or second outer clamp arm is configured to increase in thickness from a proximal end toward a distal end thereof.

30. The valve repair device of claim 1, wherein the first and second outer clamp arms extend from the distal end toward the proximal end thereof and include first, second, and third curved sections, respectively; the maximum distance between the first bending sections of the first outer clamping arm and the second outer clamping arm is smaller than the maximum distance between the second bending sections of the first outer clamping arm and the second outer clamping arm; the maximum distance between the first bending sections of the first outer clamping arm and the second outer clamping arm is larger than or equal to the minimum distance between the third bending sections of the first outer clamping arm and the second outer clamping arm.

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

32. The valve repair device of claim 1, wherein the distal end of the outer clamp element has a threaded hole for threading a drive shaft of a delivery device.

33. The valve repair device of claim 1, wherein the distal end of the outer clip element is an arcuate thickening or a base structure integrally formed at the bottom thereof.

34. The valve repair device of claim 1, wherein the outer clamp element has axial holes on either side of the distal end.

35. The valve repair device of claim 1, further comprising an outer frame assembly for being wrapped by a covering material, the outer frame assembly including first and second outer frames pivotally coupled to opposite sides of the distal end of the outer clamp element, respectively, the first or second outer frames being folded into a leaflet configuration to house the first or second outer clamp arms, respectively, in a closed state.

36. The valve repair device of claim 35, wherein the first or second outer frame includes a hub portion for being journaled on either side of the distal end of the outer clamp element, and a frame structure extending proximally from the hub portion and having an increasing width, the frame structure having a proximal end that is curved outwardly.

37. The valve repair device of claim 36, wherein the proximal end of the frame structure has a crimped structure.