Valve repair devices

Abstract

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

Description

Technical Field

[0001] The present application relates to the field of medical devices, and in particular to a valve repair device that helps repair natural heart valves. Background Art

[0002] In the cardiovascular system, natural heart valves (such as the aortic valve, pulmonary valve, mitral valve, and tricuspid valve) play a key role in ensuring an adequate supply of blood and a positive flow. However, these heart valves may be damaged by congenital malformations, inflammatory processes, infectious conditions, or diseases, thereby reducing their efficiency; for example, these disease processes include degenerative processes (such as Barlow's disease or fibroelastic disease), inflammatory processes (such as rheumatic heart disease), and infectious processes (such as endocarditis). In addition, damage to the left or right ventricle caused by a previous heart attack (i.e., myocardial infarction secondary to coronary artery disease) or other heart diseases (such as cardiomyopathy) can distort the geometry of the natural valve, which can cause the natural valve to malfunction. The vast majority of patients who undergo valve surgery, such as mitral valve surgery, suffer from degenerative diseases that cause the leaflets of the natural valve (e.g., mitral valve) to malfunction, resulting in prolapse and regurgitation.

[0003] Taking the mitral valve as an example, mitral regurgitation can be caused by a variety of different mechanical defects in the mitral valve or the left ventricular wall. The valve leaflets, the chordae connecting the leaflets to the papillary muscles, the papillary muscles themselves, or the left ventricular wall may be damaged or otherwise malfunction. Often, the annulus may become damaged, dilated, or weakened, limiting the mitral valve's ability to fully close against the significant pressures of the left ventricle. This damage can lead to severe cardiovascular damage or death.

[0004] For many years, the definitive treatment for this type of damaged valve has been surgical repair or replacement of the valve during open heart surgery. However, open heart surgery is highly invasive and prone to many complications. Therefore, elderly and frail patients with defective heart valves often go untreated. Recently, transvascular techniques have been developed for introducing and implanting prosthetic devices in a much less invasive manner than open heart surgery. A specific transvascular technique for accessing the natural mitral and aortic valves is the transseptal technique. The transseptal technique comprises inserting a catheter into the right femoral vein, up along the inferior vena cava and into the right atrium, then piercing the septum and threading the catheter into the left atrium.

[0005] However, in transseptal implantation treatment technologies, prosthetic devices such as clips usually use very complex mechanical structures to capture and clamp the natural valve, which places high operational requirements on doctors during the operation. Operations often fail during the process of clamping, opening, or flipping because the mechanical structure of the clip is too complex. After the clip clamps the natural valve, mechanical locking is required to maintain partial closure of the natural valve. However, multiple clinical trials have found that mechanical locking / attachment creates the risk of the clip falling off the natural valve with prolonged heart contraction. Summary of the Invention

[0006] In view of the shortcomings of the related technologies mentioned above, the purpose of this application is to provide a valve repair device to solve the operational inconvenience caused by the complex mechanical structure design of the clip in the related technologies and the risk of falling off caused by the mechanical locking / attachment method.

[0007] To achieve the above-mentioned purpose and other related purposes, the present application discloses a valve repair device, comprising: a spacer element, comprising a spacer body with a first stiffness, the proximal end of the spacer body being provided with a connecting portion for connecting to a delivery device, and the opposite two sides of the distal end of the spacer body respectively having a first hinge portion; an inner clamping assembly, comprising a first inner clamping arm and a second inner clamping arm respectively having a second stiffness, the proximal ends of the first inner clamping arm and the second inner clamping arm being respectively hinged to the first hinge portion; the distal ends of the first inner clamping arm and the second inner clamping arm being respectively provided with a second hinge portion; a clip assembly, arranged on the inner clamping assembly or hinged to the first hinge portion, comprising a clip assembly that can be connected relative to the first inner clamping assembly. The first clamp arm can be opened or closed, and the second clamp arm can be opened or closed relative to the second inner clamp arm, and the distal ends of the first clamp and the second clamp are respectively provided with a traction part; the outer clamp element includes a distal end and a first outer clamp arm and a second outer clamp arm integrally formed with the distal end; the proximal ends of the first outer clamp arm and the second outer clamp arm are respectively hinged to the second hinge part; the first outer clamp arm and the second outer clamp arm respectively have a third stiffness; a clamping space is formed between the first outer clamp arm and the second outer clamp arm, and when the spacer element, the clamp assembly, and the inner clamp assembly are located in the clamping space, the first outer clamp arm and the second outer clamp arm maintain a clamping force toward each other.

[0008] In summary, the valve repair device provided by the present application adopts two hinge structures to hinge the spacer element and the inner clamping assembly at the first location, and hinge the inner clamping assembly and the U-shaped outer clamping element at the second location. The two hinge structures have better flexibility than the related art that only uses one hinge structure and the other uses a folding structure. The present application requires less force when the drive shaft drives the spacer element to move toward the distal end of the outer clamping element, which is beneficial to the doctor's precision control during operation; furthermore, the present application adopts an integrally formed U-shaped outer clamping element, and utilizes the rigidity design of its outer clamping arm to continuously maintain the opposite clamping force on the components / elements in the clamping space, which has more stable performance than the mechanical locking used to ensure the clamping effect in the related art. In addition, the present application adopts an integrally formed U-shaped outer clamping element to provide a simpler structural clamping method, which has a more stable clamping effect than the related art that relies on the frame / strip to provide elastic clamping force. Moreover, compared with the prior art that uses outer and inner clamping arms formed by folding metal braided materials, it has a simpler preparation process. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The specific features of the inventions of this application are set forth in the appended claims. The features and advantages of the inventions of this application can be better understood by referring to the exemplary embodiments described in detail below and the accompanying drawings. A brief description of the drawings is as follows:

[0010] Figure 1 Shown is a schematic structural diagram of a conveying device in one embodiment of the present application.

[0011] Figure 2 Shown is a schematic diagram of the valve repair device of the present application in an extended state in one embodiment.

[0012] Figure 3 Shown is a schematic diagram of the valve repair device of the present application in an open state in one embodiment.

[0013] Figure 4 Shown is a schematic diagram of the closed state of the valve repair device of the present application in one embodiment.

[0014] Figure 5 Shown is a schematic diagram of the exploded structure of a spacer element in one embodiment of the present application.

[0015] Figure 6 Shown is a schematic diagram of the combined structure of the spacer elements in one embodiment of the present application.

[0016] Figure 7 Shown is a schematic structural diagram of a spacer element in another embodiment of the present application.

[0017] Figure 8 Shown are side views of a spacer element in two directions according to an embodiment of the present application.

[0018] Figure 9 Shown is a schematic structural diagram of a spacer element in yet another embodiment of the present application.

[0019] Figure 10 Shown is a schematic diagram of the assembly of the inner clip component in one embodiment of the present application.

[0020] Figure 11 Shown is a schematic structural diagram of the first or second inner clamping arm in one embodiment of the present application.

[0021] Figure 12 Shown is a schematic diagram of the valve repair device of the present application in an expanded state in another embodiment.

[0022] Figure 13 Shown is a schematic diagram of the coordination between the barbs and puncture holes on the clip and the inner clip arm in one embodiment of the present application.

[0023] Figure 14 Shown is a schematic diagram of the expansion and closing of a clip assembly in one embodiment of the present application.

[0024] Figure 15 Shown is a schematic diagram of a clip structure in another embodiment of the present application.

[0025] Figure 16 Shown is an exploded schematic diagram of the assembly structure of the clip and the inner clip arm in one embodiment of the present application.

[0026] Figure 17 Shown is a schematic diagram of the assembly structure of the clip and the inner clip arm in one embodiment of the present application.

[0027] Figure 18 Shown is a schematic diagram of the barb structure on the clip in another embodiment of the present application.

[0028] Figure 19 It is a schematic diagram showing an outer clamping element in a clamping state in one embodiment of the present application.

[0029] Figure 20 Shown is a schematic structural diagram of an outer clamping element in one embodiment of the present application.

[0030] Figure 21 Shown is a schematic structural diagram of a valve repair device in another embodiment of the present application.

[0031] Figure 22 Shown is a side view of an outer clamping element in one embodiment of the present application.

[0032] Figure 23 Shown is a side view of an outer clamping element in another embodiment of the present application.

[0033] Figure 24Shown is a side view of an outer clip element in yet another embodiment of the present application.

[0034] Figure 25 Shown is a schematic diagram of the cooperation between the outer clamping element and the drive shaft in one embodiment of the present application.

[0035] Figure 26 Shown is a schematic structural diagram of an outer clamping element in yet another embodiment of the present application.

[0036] Figure 27 Shown is a schematic diagram of the configuration of the outer frame component of the valve repair device in one embodiment of the present application.

[0037] Figure 28 Shown is a schematic diagram of the outer frame structure of the outer frame assembly in one embodiment of the present application.

[0038] Figure 29 Schematic diagram showing a closed state of the valve repair device of the present application in one embodiment covered with a covering material.

[0039] Figure 30 Schematic diagram showing the valve repair device of the present application in an embodiment of the present invention in an open state covered with a covering material.

[0040] Figure 31 A schematic diagram showing another embodiment of the valve repair device of the present application in an open state covered with a covering material. DETAILED DESCRIPTION

[0041] The following describes the implementation of the present application through specific embodiments. People familiar with this technology can easily understand other advantages and effects of the present application from the contents disclosed in this specification.

[0042] In the following description, reference is made to the accompanying drawings, which describe several embodiments of the present application. It should be understood that other embodiments may also be used, 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 should not be considered restrictive, and the scope of the embodiments of the present application is limited only by the claims of the published patents. The terms used herein are only for the purpose of describing specific embodiments and are not intended to limit the present application. Spatially related terms, such as "upper", "lower", "left", "right", "below", "below", "lower", "above", "upper", etc., may be used in the text to illustrate the relationship between one element or feature shown in the figure and another element or feature.

[0043] Although in some instances the terms first, second, etc. are used herein to describe various elements or parameters, 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 arm can be referred to as the second inner arm, and similarly, the second inner arm can be referred to as the first inner arm without departing from the scope of the various described embodiments. The first inner arm and the second inner arm are both describing an inner arm, but unless the context clearly indicates otherwise, they are not the same inner arm. Similar situations also include a first clip and a second clip, or a first outer arm and a second outer arm.

[0044] Furthermore, as used herein, the singular forms "a", "an", and "the" are intended to include the plural forms as well, unless the context indicates otherwise. It should be further understood that the terms "comprise", "include" indicate the presence of the described features, steps, operations, elements, components, items, kinds, and / or groups, but do not exclude the presence, occurrence, or addition of one or more other features, steps, operations, elements, components, items, kinds, and / or groups. The terms "or" and "and / or" used herein are interpreted as inclusive, or mean 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". Exceptions to this definition occur only when the combination of elements, functions, steps, or operations is inherently mutually exclusive in some way.

[0045] During the operation of the heart, the left atrium receives oxygenated blood from the lungs, and during the diastolic phase or relaxation, the blood previously collected in the left atrium moves through the mitral valve and into the left ventricle during contraction through the expansion of the left ventricle. During the systolic phase or contraction, the left ventricle contracts to force blood through the aortic valve and the ascending aorta into the body. During contraction, the leaflets of the mitral valve close to prevent blood from flowing back from the left ventricle and returning to the left atrium, and blood is collected in the left atrium from the pulmonary veins. In one example embodiment, the valve repair device described in the present application is 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 returning to the left atrium. In another example embodiment, the valve repair device described in the present application is used to repair the function of a defective tricuspid valve.

[0046] In the present application, the valve repair device can present multiple states in actual surgical applications, such as an extended state, an open state, and a closed state; the valve repair device is implanted through the delivery catheter / delivery sheath of the delivery device, the delivery sheath of the delivery device is inserted into the left atrium through the septum, and the valve repair device extends from the delivery sheath to present an extended state. When the valve repair device is delivered to the position where it enters the left ventricle in the mitral valve, it is partially opened to present an umbrella shape. At this time, the clips on the inner clamping arms on both sides are operated to capture the natural valve leaflets. After capturing the natural valve leaflets, the valve repair device is completely closed to clamp it on the natural mitral valve.

[0047] In the present application, when describing the valve repair device, "proximal end" refers to the side of the delivery device or the side in the direction of the end manipulated by the user when the valve repair device is in the extended state, and accordingly, "distal end" refers to the side of the delivery device or the side in the direction of the end manipulated by the user when the valve repair device is in the extended state.

[0048] In the present application, the "outside" in the spatial term "outside" or "outward" refers to the reference direction of the internal central axis of the valve repair device with the axis of the spacer element as the reference direction, and the radial direction of the central axis is the "outward" direction; for example, the two surfaces of the first or second spacer plate, the side surface facing the gap between the first and second spacer plates is defined as the inner surface, and the back side of the inner surface is defined as the outer surface; accordingly, in the present application, a clamping space is formed between the two outer clamping arms of the outer clamping element, and the opposite surfaces of the two outer clamping arms on both sides of the clamping space are defined as inner surfaces, and the back side of the inner surface of each outer clamping arm is defined as the outer surface.

[0049] In the present application, the spatial term "first direction" refers to the width direction of the clamping space formed between the two outer clamping arms of the outer clamping element, or the width direction of the gap between the first partition plate and the second partition plate of the partitioning element; the spatial term "second direction" refers to the direction perpendicular to the first direction. In this article, the first direction is sometimes also referred to as the horizontal direction, and the second direction is also referred to as the longitudinal direction. For the convenience of spatial description, this article may also involve a third direction, which is a direction perpendicular to the first direction and the second direction. The first direction is sometimes also referred to as the vertical direction. For example, the direction of movement of the partitioning element when driven by the drive shaft is called vertical movement or up and down movement.

[0050] In this application, the spatial term "proximity" refers to a position close to or near a component, and it should be understood that "proximity" is defined as at least close to (and including) a given position or state.

[0051] In this application, when one or more elements or members are described as being connected, joined, fixed, pivoted, hinged, coupled, attached, or otherwise interconnected, such interconnection may be directly between the members or may be indirect, such as through the use of one or more intervening members. Furthermore, as described herein, references to "component," "part," "member," or "portion" should not be limited to a single structural part, member, or element, but may include an assembly of members, parts, or elements. Furthermore, as described herein, the terms "substantially" and "approximately" are defined as at least approaching (and including) a given value or state (preferably within 10%, more preferably within 1%, and most preferably within 0.1%).

[0052] In this application, the term "hinge structure" refers to a structure that connects two parts by hinge. In a specific application, the hinge structure can be an axis-hole structure that matches the rotating shaft, or a rotating shaft that matches the axis hole, or a pivot structure; the hinge structure can be formed by folding or curling a sheet.

[0053] In this application, the term "stiffness" refers to the ability of a structure to resist elastic deformation when subjected to force. The "stiffness" is used to characterize the ease with which a structure deforms or the amount of external force required for deformation. For example, the stiffness of a spacer refers to the amount of external force required to deform the spacer, the stiffness of an inner arm refers to the amount of external force required to deform the inner arm, and the stiffness of an outer arm refers to the amount of external force required to deform the outer arm. It should be understood that the stiffness of an outer arm is less than that of an inner arm, meaning that when the outer arm deforms, the force applied to the outer arm does not cause deformation. The stiffness of the spacer element as a whole refers to the ability of the spacer element as a whole to resist elastic deformation when subjected to force.

[0054] In the present application, the term "integrally formed" refers to a structure formed in one step through a processing technology such as stamping, cutting, pouring, casting, etc. The structure is a whole element and cannot be divided.

[0055] The valve repair device described in the present application is implanted via a delivery catheter / delivery sheath of a delivery device. The delivery sheath of the delivery device is inserted into the left atrium through the septum, and the valve repair device is extended from the delivery catheter / delivery sheath. The valve repair device is extended by controlling a drive shaft extending from the delivery catheter / delivery sheath. When the valve repair device is delivered to the position where it enters the left ventricle within the mitral valve, it is partially opened to assume an umbrella shape. At this time, the clips on the inner clip arms on both sides are operated to capture the natural valve leaflets. After capturing the natural valve leaflets, the valve repair device is completely closed to achieve clamping on the natural mitral valve. The valve repair device is then detached from the valve repair device by operating the drive shaft of the delivery device, that is, by operating the release structure at the distal end of the delivery catheter / delivery sheath of the delivery device, the drive shaft is pulled out to release the engagement with the connection portion on the septum element, and the traction wire is pulled out from the traction hole of the clip assembly, thereby retaining the valve repair device on the natural valve, thereby completing partial clamping of the natural valve.

[0056] See also Figure 1 , which is a schematic diagram of the structure of the delivery device in one embodiment of the present application. As shown in the figure, in this embodiment, the delivery device 2 may include a release mechanism 21, a delivery mechanism 22, an adjustable bend mechanism 23, a loader mechanism 24 and an outer sheath mechanism 25 in sequence from the proximal end to the distal end. The delivery mechanism 22 is detachably connected to the valve repair device, and the delivery mechanism 22 is used to deliver the valve repair device to the target position. The delivery mechanism 22 includes a delivery tube 220 and a delivery handle 221. The delivery tube 220 can pass through the adjustable bend 230 and extend out of the adjustable bend. The delivery handle 221 includes a delivery shell and a pull wire control assembly 222. The distal end of the delivery shell is connected to the proximal end of the delivery tube 220, and a delivery end seal is detachably provided at the distal end of the delivery shell. The pull-wire control assembly 222 can slide axially along the delivery tube on the delivery shell. The pull-wire control assembly 222 is connected to the clip assembly of the valve repair device. When the pull-wire control assembly 222 slides axially, it controls the opening and closing of the clip assembly. 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 the valve repair device. When used, the delivery pull wire (traction wire) of the delivery structure 22 is detachably connected to the clip in the clip assembly of the valve repair device, and the drive shaft 20 (core rod) of the release structure 22 is detachably connected to the valve repair device. In some embodiments, the valve repair device can also be referred to as a transfemoral valve repair clamp.

[0057] In an exemplary embodiment of the present application, the valve repair device includes: a spacer element, an inner clip assembly, a clip assembly, and an outer clip element; in another exemplary embodiment of the present application, the valve repair device includes: a spacer element, an inner clip assembly, a clip assembly, an outer clip element, an outer frame assembly, and a covering material.

[0058] The valve repair device can present multiple state transitions in actual surgical application, such as extended state, open state, and closed state; please refer to Figures 2 to 4 , Figure 2 Shown is a schematic diagram of the valve repair device of the present application in an extended state in one embodiment. Figure 3 Shown is a schematic diagram of the valve repair device of the present application in an open state in one embodiment. Figure 4 Shown is a schematic diagram of the closed state of the valve repair device of the present application in one embodiment; as shown in the figure, the valve repair device 1 includes: a spacer element 11, an inner clamping assembly 12, a clip assembly 13, an outer clamping element 14, and an outer frame assembly 15.

[0059] exist Figure 2 In the state shown, the valve repair device 1 is in an extended state. To facilitate the display of the internal structure, Figure 2 The outer frame assembly and covering material are not shown. The extended state refers to the state when the spacer element 11 is farthest away from the distal end 143 of the outer clamping element 14. When the valve repair device 1 is in the extended state, the components in the valve repair device 1 are, from the proximal end to the distal end, the spacer element 11, the inner clamping assembly 12 (at this time, the clip assembly 13 is fixed on the inner clamping assembly 12), and the outer clamping element 14; in this state, the first hinge part 113 is at a position closer to the proximal end relative to the second hinge part 123; Figure 4 In the state shown, when the valve repair device 1 is in a closed state, the spacer element 11, the inner clamping assembly 12, and the clip assembly 13 are all retracted to be clamped in the clamping space of the outer clamping element 14. In this state, the second hinge part 123 is at a position closer to the proximal end relative to the first hinge part 113.

[0060] During the process of the valve repair device 1 being transformed from the expanded state to the closed state, it passes through an open state, in which the spacer element 11 moves toward the distal end 143 of the outer frame assembly 14. Since the first hinge 113 connects the spacer element 11 and the inner clamp assembly 12, the inner clamp assembly 12 with greater rigidity is forced to move to both sides by the linear movement of the spacer element 11. Since the second hinge 123 connects the inner clamp assembly 12 and the outer clamp assembly 14, the outer clamp assembly 14 with less rigidity is stretched and deformed by the inner clamp assembly 12, so that the valve repair device 1 as a whole presents a structure similar to an inverted umbrella, as shown in FIG. Figure 3The state shown; the spacer element 11 is driven by external force to continue to move toward the distal end 143 of the outer clamping element 14. When the outer clamping element 14 with less rigidity is stretched to the maximum extent by the inner clamping component 12, the first hinge portion 113 and the second hinge portion 123 are almost at the same height. Since the spacer element 11 continues to move linearly toward the distal end 143 of the outer clamping element 14, the distal end of the spacer element 11 connected by the first hinge portion 113 and the proximal end of the inner clamping component 12 approach the distal end 143 of the outer clamping element 14. At this time, the inner clamping component 12 is folded so that its proximal end moves toward the distal end 143 of the outer clamping element 14. The inner clamping component 12 is subjected to the elastic restoring force of the outer clamping arms on both sides of the outer clamping element 14, forcing the inner clamping arms on both sides of the inner clamping component 12 to respectively fit the two sides of the spacer element 11. At this time, the valve repair device 1 is in a closed state, as shown in the figure. Figure 4 The status shown.

[0061] The spacer element is configured to be positioned within the orifice of the native valve to help fill the space and form a more effective seal, thereby reducing or preventing the above-mentioned backflow. The spacer element may have a structure that is impermeable to blood and allows the native leaflets to close around the spacer element during ventricular contraction to prevent blood from flowing out of the left ventricle or right ventricle back into the left atrium or right atrium, respectively. The spacer element is sometimes referred to as a "connecting structure" in the applicant's previously filed patent applications 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 can fill the space between the malfunctioning native mitral or tricuspid valve leaflets that are not fully closed.

[0062] The spacer body of the spacer element has a first stiffness, that is, the overall stiffness of the spacer element is defined as the first stiffness. In actual application, the spacer element moves under the force output by the drive shaft 20 of the conveying device. When the drive shaft 20 drives the spacer element to move relative to the distal end of the outer clamping element, due to the design of its overall first stiffness, the spacer element itself will not be deformed.

[0063] See also Figure 5 and Figure 6 , Figure 5 It is a schematic diagram of the exploded structure of the spacer element in one embodiment of the present application. Figure 6Shown is a schematic diagram of the combined structure of the spacer element in one embodiment of the present application. As shown in the figure, in the embodiment, the proximal end of the spacer body 110 of the spacer element 11 has a connecting portion 111 for connecting a conveying device, and the opposite sides of its distal end respectively have a first hinge portion; in an exemplary embodiment, the spacer element 11 includes, from the proximal end toward the distal end, a connecting head 112, a neck 114, a first spacer plate 115 and a second spacer plate 116 separated from the neck and extending to the distal end, and hinge structures 1131 and 1132 formed at the distal ends of the first spacer plate 115 and the second spacer plate 116, respectively. Specifically, the connecting head 112, the neck 114, the first spacer plate 115 and the second spacer plate 116, and the hinge structures 1131 and 1132 are integrally formed.

[0064] Please refer to Figure 4 ,exist Figure 4 In the embodiment shown, when the spacer element 11, the clip assembly 13, and the inner clip assembly 12 are located in the clamping space, the connecting head of the spacer element 11 is higher than the height of the clip assembly 13, the inner clip assembly 12, or the outer clip element 14, so that the conveying device is not interfered with by any of the clip assembly 13, the inner clip assembly 12, and the outer clip element 14 when releasing the spacer element 11.

[0065] In one embodiment, the valve repair device is implanted through a delivery catheter / delivery sheath of a delivery device, the delivery sheath of the delivery device is inserted into the left atrium through the septum, and the valve repair device is extended from the delivery sheath to present an extended state. When the valve repair device is delivered to the position where it enters the left ventricle in the mitral valve, it is partially opened to present an inverted umbrella shape. At this time, the clips on the inner clamping arms on both sides are operated to capture the natural valve leaflets. After capturing the natural valve leaflets, the valve repair device is completely closed to achieve clamping it on the natural mitral valve. When it is confirmed that the valve repair device After the device has completed clamping the natural mitral valve, it needs to be separated from the delivery sheath. The delivery sheath has a release structure that is detachably connected to the valve repair device and can control the connection or separation of the delivery structure and the valve repair device. In this embodiment, the release structure includes a drive shaft 20 (or core rod), a release control end, and a repair device control assembly. The distal end of the core rod passes through the delivery tube and is detachably connected to the valve repair device. The connection between the core rod and the valve repair device is a threaded connection or a snap-on connection. The proximal end of the core rod is provided with a release control end, which connects or separates the core rod from the valve repair device via the release control end. Preferably, the release control end can adopt a release knob, which is fixed to the proximal end of the core rod. By turning the release knob, the core rod is driven to rotate to achieve detachable connection or separation with the valve repair device. In order to avoid the release structure from being interfered with or blocked during operation, the connecting head of the spacer element is higher than the height of the clip assembly or the inner clip assembly or the outer clip element, and the connecting part provided on the connecting head is also higher than the height of the clip assembly or the inner clip assembly or the outer clip element, so as to ensure that the release structure will not touch any of the clip assembly or the inner clip assembly or the outer clip element when it is manipulated to move.

[0066] In such Figure 5 and Figure 6 In the embodiment shown, the connecting head 112 of the spacer element 11 is fixed with the connecting portion 111, and the opposite sides of the connecting portion 111 respectively have ear-shaped blocks 1111 for engaging 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.

[0067] In some embodiments, the ear-shaped block 1111 may also be referred to as a connecting ear. The connecting portion 111 may also be referred to as a top seat, the connecting head 112 may be referred to as a connecting piece, and the first spacer 115 or the second spacer 116 may also be referred to as a connecting piece.

[0068] In such Figure 5 and Figure 6In the illustrated embodiment, the connecting portion 111 is on the connecting head 112, and the two are fixedly connected by an interference fit. The opposite sides of the connecting portion 111 respectively have ear-shaped blocks 1111 for engaging the above-mentioned release structure in the conveying device, and a detachable connection is achieved with the external conveying device through the ear-shaped blocks 1111; accordingly, the release structure of the conveying device (not shown) includes two cards with card holes corresponding to the ear-shaped blocks 1111, and the cards are elastic and are restricted on the core rod by being penetrated. After the core rod is pulled out, the cards on both sides are released due to their own elasticity and are in a state of opening to both sides, thereby achieving the purpose of separating the card holes and the ear-shaped blocks on the cards. Therefore, in order to avoid interference or obstruction when the cards are released and opened to both sides, the height of the connecting head of the spacer element is set to be higher than the height of the clip assembly or the inner clip assembly or the outer clip element (the height here refers to the height of each part of the valve repair device in the closed state).

[0069] See also Figure 7 , which is a schematic structural diagram of a spacer element in another embodiment of the present application. As shown in the figure, Figure 7 In an exemplary embodiment, the height H of the connecting portion 111 on the connector of the spacer element 11 can be set by increasing the length of the neck 114 of the spacer element 11 .

[0070] In one embodiment, an ear-shaped card block 1111 is provided on each side of the connecting portion 111 of the spacer element 11, and accordingly, the release structure of the conveying device has four cards corresponding to each ear-shaped card block 1111, thereby ensuring that the valve repair device is set on the delivery sheath of the conveying device in a more secure manner; or, in another embodiment, the release structure of the conveying device is still two cards with card holes corresponding to the ear-shaped card blocks 1111, so that after the release structure of the conveying device releases the valve repair device, when it is necessary to capture the valve repair device, the success rate of the two cards of the release structure in capturing the connecting portion 111 of the spacer element 11 is increased, and the capture of the ear-shaped card blocks 1111 on any two opposite sides can achieve the capture of the connection portion.

[0071] In such Figure 5 and Figure 6 In the embodiment shown, the extension direction of the ear-shaped blocks 1111 on both sides of the connecting portion 111 of the spacer element 11 is parallel to the plate surface of the first spacer plate 115 and the second spacer plate 116, so as to ensure that when the valve repair device is in a closed state, the outer clamping arms on both sides of the outer clamping element of the valve repair device, the inner clamping arms on both sides of the inner clamping assembly, and the two clamps of the clamping assembly are not on the same side as the ear-shaped blocks 1111 on both sides of the connecting portion, thereby effectively avoiding interference or obstruction when the card is released to open to both sides.

[0072] The connecting portion 111 and the connecting head 112 of the spacer element 11 define a through hole 117 for the conveyor drive shaft 20 to pass through. This allows the conveyor drive shaft 20 to pass through the spacer element 11 until it engages the distal end of the outer clamping element. Accordingly, a gap is defined between the distal ends of the first spacer plate 115 and the second spacer plate 116 of the spacer element 11 for the conveyor drive shaft 20 to pass through. In another embodiment, when the distal ends of the first spacer plate and the second spacer plate of the spacer element are joined together, a through hole is formed at the joint for the conveyor drive shaft 20 to pass through.

[0073] In one embodiment, the neck portion 114 of the spacer element 11 includes a bridge structure 1141 for separating the first spacer 115 from the second spacer 116. The bridge structure 1141 includes a curved surface formed on the inner wall at the connection point, thereby separating the first spacer 115 from the second spacer 116 by a predetermined distance. In this embodiment, the bridge structure 1141 forms a sealed end, the thickness of which is greater than the thickness of the remaining portions (the first spacer 115 and the second spacer 116). In this embodiment, the length of the sealed end is no less than 1 / 4 of the total length of the first spacer 115 or the second spacer 116. To prevent the two ear-shaped blocks 1111 (connecting ears) on the same side as the inner clip assembly and the clip assembly from blocking the removal of the native / natural valve leaflet after clamping, the sealed end is designed to be longer, thereby increasing the distance between the ear-shaped blocks 1111 and the inner clip assembly and the clip assembly.

[0074] In this embodiment, the neck 114 is a reinforced structure. Specifically, the bridge structure 1141 used to separate the first partition plate 115 and the second partition plate 116 is designed to be thicker than the first partition plate 115 and the second partition plate 116 to enhance the rigidity of the neck 114. The first partition plate 115 and the second partition plate 116 extend from the bridge structure 1141 to the distal end and begin to separate to form two sheets with a gap.

[0075] See also Figure 8 , which shows a side view of the partition element in two directions in one embodiment of the present application. As shown in the figure, the width W1 of the bridge structure 1141 in the first direction is greater than the maximum separation width W2 of the first partition plate 115 and the second partition plate 116; the width W3 of the bridge structure 1141 in the second direction is less than the maximum width W4 of the first partition plate 115 or the second partition plate 116, as shown in FIG. Figure 8As shown in (a) and (b); in this embodiment, the first direction is defined as the transverse direction, and the second direction is defined as the longitudinal direction. The transverse width W1 of the bridge structure 1141 is greater than the maximum separation width W2 of the first spacer 115 and the second spacer 116; the longitudinal width W3 of the bridge structure 1141 is less than the maximum width W4 of any one of the first spacer 115 or the second spacer 116. This design is to form a recessed structure at the transition portion between the neck and the first spacer 115 and the second spacer 116, which not only strengthens the overall rigidity of the spacer element, but also forms a space at the neck of the spacer element that facilitates the clip assembly, the inner clip assembly, and the outer clip assembly to fit more closely to the first spacer 115 and the second spacer 116 of the spacer element in the closed state, so as to achieve a better sealing effect and effectively fill the space between the incompletely closed and malfunctioning natural mitral or tricuspid valve leaflets, thereby reducing or preventing blood reflux.

[0076] In one embodiment, the spacer element separates the first spacer plate 115 and the second spacer plate 116 via its bridge structure 1141, and the plate surface gap between the first spacer plate 115 and the second spacer plate 116 decreases from the bridge structure 1141 toward the distal ends of the first spacer plate 115 and the second spacer plate 116, that is, the plate surface gap near the bridge structure 1141 is larger than the plate surface gap at the distal ends of the first spacer plate 115 and the second spacer plate 116, as shown in FIG. Figure 8 In this embodiment, the gap between the distal ends of the first spacer 115 and the second spacer 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 spacer element and reaches the distal end of the outer clamping element.

[0077] In some embodiments, the cross-section of the first spacer 115 or the second spacer 116 can be semicircular, that is, the inner surface of the first spacer 115 and the second spacer 116 relative to each other is flat, and the outer surface is an arc surface; or other cross-sectional shapes that are conducive to achieving the matching function.

[0078] In one embodiment, the width of the plate body of the first spacer or the second spacer decreases toward the hinge structure at its distal end. In this embodiment, the plate body of the first spacer or the second spacer is not designed with a uniform width. The plate body adopts a structure with a decreasing width from the proximal end to the distal end. For details, please refer to Figure 9, which is a schematic diagram of the structure of the intermediate spacer element in another embodiment of the present application. After the plate body of the first spacer 115 is separated from the bridge structure 1141, it extends to a certain length and then one side edge of the plate body (for example, defined as the first side edge 1150) begins to shrink inward, causing the width of the plate body to gradually narrow until it reaches the hinge portion at the far end. Correspondingly, after the plate body of the contracted second spacer 116 is separated from the bridge structure 1141, it extends to a certain length and then one side edge of the plate body (for example, defined as the second side edge 1160) begins to shrink inward, causing the width of the plate body to gradually narrow until it reaches the hinge portion at the far end. , such a design can obtain a narrower or shorter hinge portion, which is beneficial to reduce the mechanical friction of the hinge portion, making the hinge of the spacer element 11 and the inner clamping assembly more flexible; in this embodiment, the width of the plate body connected by the intersection of the first hinge portion at the distal end of the first spacer plate 115 and the second spacer plate 116 is narrow, and the friction generated is smaller. When the drive shaft 20 drives the spacer element 11 to move toward the distal end of the outer clamping element to open the outer clamping arm of the outer clamping element, the thrust required by the drive shaft 20 is smaller, making it easier for the inner clamping arm of the inner clamping assembly to open the outer clamping arm of the outer clamping element.

[0079] According to the above description, a portion of the first side of the first spacer 115 extends inwardly, and a portion of the second side of the second spacer 116 extends inwardly. In this way, the hinge structure of the first spacer 115 and the hinge structure of the second spacer 116 are staggered with each other, thereby ensuring the balance of force on the first hinged part. In this embodiment, the plate bodies of the two spacers of the spacer element are designed as the above-mentioned asymmetric mechanism. In this way, when the clamping mechanism moves back and forth due to the precision between the components not meeting the requirements, the asymmetric structure will generate a rebound force, thereby increasing the mechanical stability of the entire valve repair device.

[0080] exist Figure 8In the illustrated embodiment, the spacer element has first hinged portions 113 on opposite sides of the distal end of the spacer body. In this embodiment, the maximum width W5 of the first hinged portion 113 of the first spacer plate 115 and the first hinged portion of the second spacer plate 116 in the first direction is no greater than the maximum width W6 of the connecting portion 111 of the spacer element 11 in the first direction. In this embodiment, the hinged structure formed at the distal end of the first spacer plate 115 or the second spacer plate 116 is an outwardly curled hinge structure. In this embodiment, the maximum width W5 of the hinge structure of the first spacer plate 115 or the second spacer plate 116 in the first direction is no greater than the maximum width W6 of the connecting portion 111 of the spacer element 11 in the first direction. This limits the overall width of the proximal and distal ends of the spacer element, thereby facilitating the spacer element from occupying additional radial space when placed in a delivery catheter of a delivery device with a restricted valve repair device.

[0081] Present as Figure 8 In the embodiment shown in (a), the outward curling of the hinge structure refers to curling in a direction away from the gap between the first partition plate 115 and the second partition plate 116, so that the axis point of the first hinge portion falls outside the main body of the partition element, which is beneficial to the hinge of the inner clamp assembly. When the inner clamp assembly is hinged on the first hinge portion, since the hinge structures curled outward on both sides of the first partition plate 115 and the second partition plate 116 have a certain distance, the first inner clamp arm and the second inner clamp arm of the inner clamp assembly will not interfere with each other when rotating.

[0082] Present as Figure 5 、 Figure 6 or Figure 8 In the embodiment shown in (b), the first spacer 115 and the second spacer 116 of the spacer element have plate bodies of uniform width, and the distal ends of the first spacer 115 or the second spacer 116 form a hinge structure as two separate and outwardly curled hinge structures, so that the proximal end of the inner clamp arm of the inner clamp assembly is hinged between the two separate and outwardly curled hinge structures, thereby forming a pivotally stable hinge and ensuring the force balance of the hinge point.

[0083] Present as Figure 9 In the embodiment shown, the first spacer 115 and the second spacer 116 of the spacer element have plate bodies of uneven width. A portion of the first side of the first spacer 115 extends inwardly, and a portion of the second side of the second spacer 116 extends inwardly. In this way, the hinge structure formed on the first spacer 115 and the hinge structure formed on the second spacer 116 are staggered with each other, thereby ensuring the force balance of the hinge points on both sides of the spacer element.

[0084] In this application, the inner clip assembly is hinged to the distal end of the spacer element by a hinged manner, see Figure 10 , shows a schematic assembly diagram of an inner clamp assembly according to one 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. The proximal end of the first inner clamp arm 121 is hinged to the first hinge portion of the first spacer plate 115, and the proximal end of the second inner clamp arm 122 is hinged to the first hinge portion 113 of the second spacer plate 116. The first inner clamp arm 121 and the second inner clamp arm 122 have the same stiffness, that is, the first inner clamp arm 121 has a second stiffness, and the second inner clamp arm 122 also has a second stiffness. In one embodiment, the second stiffness is less than or equal to the first stiffness, and in another embodiment, the second stiffness is greater than the first stiffness. In the present application, the second stiffness refers to the fact that the forces applied to the proximal and distal ends of the first inner clamp arm 121 or the second inner clamp arm 122 by the spacer element 11 and the outer clamp element 14 do not cause deformation of the plate body of the first inner clamp arm 121 or the second inner clamp arm 122. A second hinge portion 123 is respectively defined at the distal end of the first inner clamping arm 121 and the distal end of the second inner clamping arm 122 .

[0085] In an embodiment, the spacer element 11, the inner clamp assembly 12 and the outer clamp element 14 can be made of the same material. For example, the spacer element 11, the inner clamp assembly 12 and the outer clamp element 14 are obtained by laser cutting nitinol material or nickel titanium material. To ensure the stiffness distribution of the three, in this embodiment, the plate thickness of the first inner clamp arm 121 or the second inner clamp arm 122 is greater than the plate thickness of the first spacer plate 115 or the second spacer plate 116 in the spacer element 11; the plate thickness of the first inner clamp arm 121 or the second inner clamp arm 122 is greater than the plate thickness of the first outer clamp arm and the second outer clamp arm in the outer clamp element 14.

[0086] See also Figure 11, which is a schematic structural diagram of the first or second inner clamping arm in one embodiment of the present application. As shown in the figure, in this embodiment, the proximal end of the first inner clamping arm 121 has a hinge structure 1231 that curls outward; the distal end of the first inner clamping arm 121 has a hinge structure 1232 that curls inward, and accordingly, the proximal end of the second inner clamping arm 122 has a hinge structure 1231 that curls outward; the distal end of the second inner clamping arm 122 has a hinge structure 1232 that curls inward. Since the hinge points of the first inner clamping arm 121 and the second inner clamping arm 122 are distributed on different sides at both ends of their respective plates, when the first inner clamping arm 121 and the second inner clamping arm 122 are subjected to 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 force more efficiently, and the thrust required by the drive shaft 20 of the conveying device is smaller, thereby making it easier for the two inner clamping arms of the inner clamping assembly to open the two outer clamping arms of the outer clamping element 14.

[0087] 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 preset strength so that it is not easily deformed when a force is applied to both ends.

[0088] See also Figure 12 , which is a schematic diagram of the valve repair device of the present application in an extended state in another embodiment. As shown in the figure, as in the above-mentioned spacer element 11, the plate bodies of the first spacer 115 and the second spacer 116 are plate bodies with uneven widths, in an embodiment in which the hinge structure 1131 of the first spacer 115 and the hinge structure 1132 of the second spacer 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 clamp arm 121 or the second inner clamp arm 122 are staggered with each other along the plate body direction, so that the proximal ends of the first inner clamp arm 121 and the second inner clamp arm 122 are respectively hinged to the first hinge portion 113 at the distal end of the first spacer 115 and the second spacer 116. Since the hinge width at the intersection of the first hinge portion 113 is narrow, the friction force generated is small. When the drive shaft 20 drives the spacer element 11 to move toward the distal end of the outer clamping element 14 to open the outer clamping arm of the outer clamping element 14, the thrust required by the drive shaft 20 is smaller.

[0089] As mentioned above, the plate bodies of the first partition plate 115 and the second partition plate 116 of the spacer element 11 are plates of uniform width, and in an embodiment in which the hinged structure formed at the distal end is two separate and outwardly curled hinge structures, correspondingly, the hinge structures at the proximal ends and the distal ends of the first inner clamp arm 121 and the second inner clamp arm 122 are aligned with each other along the direction of their plate bodies, so that the proximal ends of the first and second inner clamp arms 122 of the inner clamp assembly are hinged between the two separate and outwardly curled hinge structures. The mutual alignment means that the hinge structure at the proximal end and the hinge structure at the distal end of the first inner clamp arm 121 or the second inner clamp arm 122 are arranged on the same central axis, thereby ensuring the force balance of the hinge point.

[0090] In this application, Figures 2 to 4 As well as the above Figure 12 In the embodiment shown, the first inner clamping arm 121 and the second inner clamping arm 122 of the inner clamping assembly 12 are respectively provided with a first clamping piece 131 and a second clamping piece 132. Figure 11 In the embodiment shown, the plate body near the proximal end of the first inner clamp arm 121 has an opening 1211 for passing the first clip 131, specifically, the opening 1211 is used for a portion of the first clip 131 to pass through from one side (such as the front) of the plate body of the first inner clamp arm 121 and be combined to the other side (such as the back). Correspondingly, the plate body near the proximal end of the second inner clamp arm 122 has an opening for passing the second clip 132, specifically, the opening is used for a portion of the second clip 132 to pass through from one side (such as the front) of the plate body of the second inner clamp arm 122 and be combined to the other side (such as the back). In this embodiment, the plate body of the first inner clamp arm 121 or the second inner clamp 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 clip 131 and the second clip 132 are respectively fixed to the first inner clip arm 121 and the second inner clip arm 122 by welding, but it is not limited to this. In other embodiments, the first clip 131 and the second clip 132 can also be respectively fixed to the first inner clip arm 121 and the second inner clip arm 122 by riveting or screwing.

[0091] exist Figure 11In the embodiment shown, the first inner clamp arm 121 and the second inner clamp arm 122 are respectively provided with a limit block 1212 on the plate body. The limit block 1212 is located at a position close to the distal end of the plate body of the first inner clamp arm 121 and the second inner clamp arm 122. The limit block 1212 has a certain height. Since the first clip 131 and the second clip 132 are respectively provided on the first inner clamp arm 121 and the second inner clamp arm 122 for opening and closing movement, the cooperation between the first clip 131 and the first inner clamp arm 121 is used as an example for explanation. When the first clamp 131 is closed to be in contact with the surface of the first inner clamp arm 121 (for example, the front side), since the first clamp 131 has a barb on the side corresponding to the surface of the first inner clamp arm 121, in order to ensure that the first clamp 131 does not directly contact the surface of the first inner clamp arm 121 and cause the barb to be compressed and deformed, a certain gap needs to be reserved between the first clamp 131 and the first inner clamp arm 121. Therefore, the height of the limit block determines the relative distance between the first inner clamp arm 121 and the first clamp 131; accordingly, the cooperation method of the second clamp 132 and the second inner clamp arm 122 is the same.

[0092] In an embodiment, a certain gap of 1 mm to 3 mm is reserved between the first clip 131 and the first inner clamping arm 121. Specifically, in some embodiments, the gap is 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, 2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm, or 3 mm.

[0093] In addition, since the first clip 131 and the second clip 132 are fixed to the plate body of the first inner clamp arm 121 and the second inner clamp arm 122 by welding or riveting, as in the above example, when the first or second clip is fixed to the plate body of the first inner clamp arm 121 and the second inner clamp arm 122, it is necessary to ensure the positioning accuracy of the fixed position of the two. The limit blocks 1212 on the plate body of the first inner clamp arm 121 and the second inner clamp arm 122 have a positioning function. Taking the fixing of the first clip 131 to the first inner clamp arm 121 as an example, a part of the first clip 131 (for example, the elastic structure of the tongue on the first clip 131 in the following example) is extended from the first inner clamp arm 121 The opening near the proximal end of the plate body passes through to the other side and the first clip 131 is fixed by welding or riveting. The barb on the first clip 131 and the limit block 1212 are both located in the position space between the first clip 131 and the first inner clamp arm 121. Therefore, the relative position of the barb on the first clip 131 and the limit block 1212 can be used to determine whether the first clip 131 is accurately positioned, thereby ensuring that the first clip 131 is accurately fixed at the ideal position of the first inner clamp arm 121. In actual operation, the barb on the first clip 131 can be pressed against the root of the limit block 1212 to position the first clip 131 at the ideal position of the first inner clamp arm 121.

[0094] See also Figure 13 , showing a schematic diagram of the cooperation between the clip and the barbs and the puncture holes on the inner clip arm in one embodiment of the present application, as shown in the figure, in the embodiment, the plate body of the first inner clip arm 121 or the second inner clip arm 122 is provided with a puncture hole or puncture groove 1214 corresponding to the barbs 1312 on the first clip 131 or the second clip 132, so that when the first clip 131 and the second clip 132 are clamped with the first inner clip arm 121 and the second inner clip arm 122, the barbs on the first clip 131 or the second clip 132 can pierce the puncture hole or puncture groove In the groove, the example of the first clip 131 clamping relative to the first inner clamp arm 121 is still used for explanation. When the natural valve leaflet is captured between the first clip 131 and the first inner clamp arm 121, the barbs or barbs on the first clip 131 pierce the natural valve leaflet and then penetrate into the puncture holes or puncture grooves on the plate body of the first inner clamp arm 121, thereby more stably maintaining the natural valve leaflet between the first clip 131 and the first inner clamp arm 121, avoiding the risk of the valve repair device falling off due to the beating of the heart.

[0095] See also Figure 10As shown in the figure, the clip assembly 13 includes a first clip 131 and a second clip 132. The first clip 131 of the clip assembly has a fourth stiffness, and the second clip 132 also has a fourth stiffness. The fourth stiffness is less than the third stiffness. In other words, the first clip 131 and the second clip 132 are more flexible and elastic than the first outer clamping arm 141 and the second outer clamping arm 142 of the outer clamping element 14. In the present application, the first clip 131 and the second clip 132 are integrally formed spring structures. In an embodiment, the first clip 131 and the second clip 132 are made from a shape memory alloy sheet, such as by Nitinol laser cutting.

[0096] In some embodiments, the clip assembly 13 is also referred to as a clamping structure. Accordingly, the first clip 131 may also be referred to as a first clamping piece, and the second clip 132 may also be referred to as a second clamping piece.

[0097] See also Figure 14 , shows a schematic diagram of the expansion and closing of the clip assembly in one embodiment of the present application. As shown in the figure, in the embodiment, the first clip 131 is provided on the first inner clip arm 121, and the distal ends of the first clip 131 are respectively provided with traction portions 1313. Specifically, the traction portions 1313 are traction holes 1313 and 1323 for passing the traction line. In one embodiment, the traction hole 1313 is provided on the sheet body of the first clip 131; in another embodiment, the traction hole can also be a perforated structure formed at the distal end of the first clip 131 and curled outward. When the traction hole 1313 of the first clip 131 is subjected to the traction force of the traction line 30, it opens relative to the first inner clip arm 121 (in a shape as shown in FIG. Figure 14 Accordingly, when the traction force is eliminated, the first clip 131 closes relative to the first inner clamp arm 121 due to its own elastic restoring force (as shown in FIG. Figure 14The second clip is shown in a state where the traction force of the pull line is eliminated. Accordingly, the second clip 132 is disposed on the second inner arm 122. A traction portion 1323 is provided at the distal end of each of the second clips 132. Specifically, the traction portion 1323 is a traction hole for passing the traction line 30. In one embodiment, the traction hole is formed in the body of the second clip 132. In another embodiment, the traction hole is a perforated structure formed at the distal end of the second clip 132 and curled outward. When the traction force of the traction line 30 is applied to the traction hole of the second clip 132, it opens relative to the second inner arm 122. Accordingly, when the traction force is eliminated, the second clip 132 closes relative to the second inner 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 arm 121 or the second inner arm 122, respectively, is controlled by the traction force of the traction line.

[0098] In some embodiments, the traction wire 30 is also called a control wire. In one embodiment, the traction wire 30 (control wire) can also be connected to a capture ring 31, and the capture ring 31 is connected to the traction wires in the first clip 131 and the second clip 132 respectively. The traction wires 30 connected to the first clip 131 and the second clip 132 are commonly connected to the same capture ring 31 for recovering the valve repair device 1 of the present application. For example, during a routine inspection in the later stage, if it is found that the valve repair device 1 is not clamped well and needs to be re-clamped or the valve repair device 1 needs to be withdrawn for other reasons, there is no need to open the heart, only need to send the snare into the heart to capture the capture ring 31, and after the capture is completed, pull back the snare, the first clip 131 and the second clip 132 are pulled up and opened, and the captured native / natural leaflet is released again, and the snare is continued to be pulled back to pull the valve repair device 1 back into the sheath to complete the recovery.

[0099] In an embodiment, the proximal end of the first clip 131 or the second clip 132 has an elastic structure to ensure that an elastic restoring force can be provided to the first clip 131 or the second clip 132 when the traction force out of the traction hole is eliminated. In a specific implementation, the elastic structure can be realized by one or more methods such as cutting, reducing material, and bending the clip body.

[0100] In an embodiment, a bending structure 1314 is formed near the proximal end of the first clip 131 or the second clip 132 to form a preset distance between the surface of the first clip 131 or the second clip 132 and the surface of the first inner clamp arm 121 or the second inner clamp arm 122. The bending structure 1314 also serves as an elastic structure to provide elastic restoring force to the clip, as shown in FIG. Figure 13 The structure shown.

[0101] In one embodiment, the elastic sheet of the first clip 131 or the second clip 132 is a sheet with uniform width; in another embodiment, the elastic sheet is a sheet with different width distributions, see Figure 15 , which is a schematic diagram of the 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 a pair 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, and the notch structure is a symmetrical structure on the sheet body to ensure the uniformity of its force.

[0102] See also Figure 16 , shows an exploded schematic diagram of the assembly structure of the clip and inner clip arm in one embodiment of the present application. As shown in the figure, the first clip 131 and the second clip 132 are fixed to the plate body of the first inner clip arm 121 and the second inner clip arm 122 by welding or riveting. In the above embodiment, the first clip 131 or the second clip 132 respectively includes an elastic sheet 1310 with a hollow structure, a tongue 1311 extending from the proximal end of the elastic sheet, and a barb 1312 formed on the elastic sheet body 1310. Specifically, the elastic sheet 1310, the tongue 1311, and the barb 1312 are all integrally formed on the first clip 131 or the second clip 132, for example, by cutting, trimming, or stamping. In some cases, the tongue 1311 can also serve as a fixing piece.

[0103] See also Figure 17, which is a schematic diagram of the assembly structure of the clip and the inner clip arm in one embodiment of the present application. As shown in the figure, the first clip 131 or the second clip 132 has a tongue 1311 extending from the proximal end of the elastic sheet 1310 near its proximal end. The tongue 1311 has a certain length, and a part of the tongue 1311 is welded or riveted to the first inner clip arm 121 or the second inner clip arm 122. The first clip is still fixed to the first inner clip arm 121 as an example for explanation. The tongue 1311 of the first clip passes through the opening 1211 of the first inner clip arm 121 and is combined with the back of the first inner clip arm 121, and then is welded or riveted. The tongue piece 1311 is fixed to the back side of the first inner clamp arm 121, and the main part of the first clamp piece 131 (that is, the part with the barbs) is still located on the front side of the first inner clamp arm 121. In this way, the first clamp piece 131 can be fixed to the first inner clamp arm 121. Since the above-mentioned tongue piece 1311 has a certain elastic performance, it can not only fix the first clamp piece 131, but also achieve the purpose of elastic combination of the proximal end of the first clamp piece 131 and the proximal end of the first inner clamp arm 121, thereby achieving the purpose of elastic closure of the first clamp piece 131 relative to the first inner clamp arm 121; accordingly, the cooperation method of the second clamp piece 132 and the second inner clamp arm 122 is the same.

[0104] In an embodiment, the angle between the barb 1312 in the first clip 131 or the second clip 132 and the elastic sheet 1310 is 15°-60°. In this embodiment, the extension direction of the barb 1312 is inclined at 15°-60° toward the proximal end of the first clip 131 or the second clip 132. Specifically, in some embodiments, the angle can 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 angles of the barbs 1312 described above provide a further benefit in that the first clip 131 or the second clip 132 can be pulled away from the native leaflet.

[0105] In an embodiment, the length of the barb 1312 in the first clip 131 or the second clip 132 is 0.3-3 mm. Specifically, in some embodiments, the length of the barb 1312 is 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, 2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm, or 3 mm.

[0106] See also Figure 18 , which is a schematic diagram of the barb structure on the clip in another embodiment of the present application. As shown in the figure, the root width of the barbs in the first clip 131 or the second clip 132 is smaller than the middle width, that is, each barb 131 extends from the elastic sheet at the above-mentioned inclination angle, and its root 13121 has a narrower width, and then the width increases to transition to the middle part 13122, and then decreases in width until a sharper needle tip 13123 is formed. The barbs 1312 formed in this way can better keep 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.

[0107] In one embodiment, the barbs distributed on the elastic sheet of the first clip 131 or the second clip 132 are a group of barbs, which includes three barbs or four barbs 1312 arranged adjacent to the distal end of the first clip 131 or the second clip 132; in another embodiment, for example, Figures 13 to 18 In the embodiment shown, the barbs 1312 on the first clip 131 or the second clip 132 are multiple groups, wherein the number of barbs 1312 in one group adjacent to the distal end is greater than the number of barbs 1312 in other groups, for example, the number of barbs in one group adjacent to the distal end is 3 barbs or 4 barbs, and the number of barbs in other groups is 1 barb or 2 barbs.

[0108] In one embodiment, when there are multiple groups of barbs on the first clip 131 or the second clip 132, each group of barbs can be arranged at regular intervals, such as with regular fixed spacing or equidistant gradient spacing; in one embodiment, multiple groups of barbs can also be arranged in a staggered manner, such as the barb positions are arranged in a staggered manner.

[0109] In one embodiment, the first clip 131 or the second clip 132 is a double-layer spring sheet (not shown) comprising an inner spring sheet and an outer spring sheet. The inner spring sheet is provided with barbs, and the outer spring sheet adheres to the inner spring sheet to reinforce the elastic force or clamping force of the clamping sheet. The inner and outer spring sheets are joined at the proximal end. In this embodiment, the inner and outer spring sheets can be joined at the proximal end by welding or riveting, or the inner and outer spring sheets are integrally formed and joined at the proximal end by bending.

[0110] Taking the first clip 131 as an example, the first clip 131 has a double-layered spring structure, including an inner spring and an outer spring. To increase the elasticity of the outer spring, the outer spring may be a hollow structure. The inner spring comprises a hollowed-out elastic sheet, a tongue extending from the proximal end of the elastic sheet, and barbs formed on the elastic sheet body. The first clip 131, with its double-layered spring structure, is secured to the back of the first inner arm 121 by welding or riveting the elastic sheet extending from the proximal end of the inner spring. In this embodiment, the distal end of the first clip 131, with its double-layered spring structure, has a traction hole. Specifically, traction holes for a traction wire are provided at corresponding positions on the inner and outer springs, allowing traction to force the first clip 131 to expand relative to the first inner arm 121. Correspondingly, the double-layered spring structure and configuration of the second clip 132 are similar.

[0111] In the present application, the outer clamping element 14 is an integrally formed component. Figure 2 or Figure 10 In the illustrated embodiment, the outer clamping element 14 is a U-shaped element, comprising a first outer clamping arm 141, a second outer clamping arm 142, a distal end portion 143 where the first and second outer clamping arms 141, 142 are integrated at their distal ends, and hinged portions 123 formed at the proximal ends of the first and second outer clamping arms 141, 142. The first outer clamping arm 141 has a third stiffness, and the second outer clamping arm 142 also has the same third stiffness. In this application, the overall stiffness of the first outer clamping arm 141 or the second outer clamping arm 142 is defined as the third stiffness. The stiffness distribution of the first outer clamping arm 141 or the second outer clamping arm 142 is less at the proximal end than at the distal end. 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 a clamping force toward each other.

[0112] In some embodiments, the outer clamping element 14 can also be referred to as a U-shaped structure formed by two power-assisting sheets, and the first outer clamping arm 141 or the second outer clamping arm 142 of the outer clamping element 14 can also be referred to as a clamping strip.

[0113] Please refer to Figures 2 to 4 Also see Figure 19 , Figure 19 The diagram shows a schematic diagram of an outer clamping element in a clamping state in one embodiment of the present application. As shown in the figure, the outer clamping element 14 includes a distal end 143 and a first outer clamping arm 141 and a second outer clamping arm 142 integrally formed with the distal end 143 and having a third stiffness respectively; the proximal ends of the first outer clamping arm 141 and the second outer clamping arm 142 are respectively hinged to the second hinge portion 123; in this embodiment, the hinge structure formed at the proximal end of the first outer clamping arm 141 or the second outer clamping arm 142 is two separate and outwardly curled hinge structures, which are used to hinge the second hinge portion 123 at the distal ends of the first inner clamping arm 121 and the second inner clamping arm 122 of the inner clamping assembly, so as to connect the first inner clamping arm 141 and the second inner clamping arm 122 of the inner clamping assembly to the second hinge portion 123 at the distal ends of the first inner clamping arm 141 and the second inner clamping arm 122 of the inner clamping assembly. The first inner clamp arm 121 and the second inner clamp arm 122 are respectively opened to both sides by the downward movement of the spacing element 11, so as to stretch the first inner clamp arm 121 and the second inner clamp arm 122 to both sides through the hinged movement of the second hinge part 123, and when the spacing element 11 continues to move downward to cause the first inner clamp arm 121 and the second inner clamp arm 122 to be clamped inward, the first outer clamp arm 141 and the second outer clamp arm 142 are clamped toward each other by their own elastic restoring force, thereby locating the spacing element 11, the clip assembly 13, and the inner clamp assembly 12 in the clamping space, and due to the elasticity of the first outer clamp arm 141 and the second outer clamp arm 142 themselves, they maintain the clamping force F towards each component / element in the clamping space.

[0114] exist Figure 2 or Figure 3 as well as Figure 19 In the embodiment shown, the proximal end and the distal end 143 of the first outer clamping arm 141 or the second outer clamping arm 142 have the same width, that is, the first outer clamping arm 141 and the second outer clamping arm 142 are both plates with the same width. In this embodiment, in order to ensure that the stiffness distribution of the proximal portion of the first outer clamping arm 141 or the second outer clamping arm 142 is less than the stiffness distribution of the distal portion, the first outer clamping arm 141 or the second outer clamping arm 142 has a structure with increasing thickness from the proximal end toward the distal end 143, as shown in FIG. Figure 19As shown, the thickness of the plate body of the first outer arm 141 or the second outer arm 142 near its proximal end is d1, and the thickness of the plate body of the first outer arm 141 or the second outer arm 142 near its distal end 143 is d2. Thickness d1 is less than thickness d2. This allows the portion of the first outer arm 141 or the second outer arm 142 near its proximal end to have greater elasticity, while the portion of the first outer arm 141 or the second outer arm 142 near its distal end 143 to have relatively weaker elasticity. In the present application, the stiffness distribution of the first outer arm 141 or the second outer arm 142, including both the proximal end and the distal end 143, is a gradual rather than sudden change in stiffness.

[0115] In an embodiment in which the first outer clamp arm 141 or the second outer clamp arm 142 is a plate of the same width, the hinge structure formed at the proximal end of the first outer clamp arm 141 or the second outer clamp arm 142 is two separate and outwardly curled hinge structures 1410, 1420, so that the distal hinge structure 1231 or 1232 of the first inner clamp arm 121 or the second inner clamp arm 122 is hinged between the above-mentioned two separate and outwardly curled hinge structures 1410, 1420, thereby forming a pivotally stable hinge, ensuring the force balance of the hinge point.

[0116] In one embodiment, the width of the first outer clamp arm 141 or the second outer clamp arm 142 is greater than the width of the first inner clamp arm 121 or the second inner clamp arm 122, and the width of the first outer clamp arm 141 or the second outer clamp arm 142 is greater than the width of the first clip 131 or the second clip 132, so as to be able to shield these components when the outer clamp element 14 folds the spacer element 11, the inner clamp assembly, and the clip assembly into their clamping space.

[0117] See also Figure 20 , which is a schematic structural diagram of an outer clamping element in one embodiment of the present application. As shown in the figure, in this embodiment, the hinge structure formed at the proximal end of the first outer clamping arm 141 or the second outer clamping arm 142 is a hinge structure 1410, 1420 that curls outward, and the hinge structures 1410 and 1420 of the first outer clamping arm 141 and the second outer clamping arm 142 are staggered with each other, so that the proximal end of the first outer clamping arm 141 or the second outer clamping arm 142 is respectively hinged to the second hinge portion 123 at the distal end of the first inner clamping arm 121 and the second inner clamping arm 122 (for ease of understanding, Figure 20Only one side of the inner clamp arm and clip is shown in the figure). Since the hinge width at the intersection of the second hinge portion 123 is narrow, the friction force generated is small. When the drive shaft 20 drives the spacer element 11 to move toward the distal end 143 of the outer clamp element 14 to open the two inner clamp arms of the inner clamp element, the two inner clamp arms will open the first outer clamp arm 141 and the second outer clamp arm 142. The small friction at the hinge will not affect the force applied by the two inner clamp arms. Figure 12 In the structure shown, the width 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 decreasing width from its distal end 143 toward its proximal end, and correspondingly, the second outer clamping arm 142 also has the same structure. Figure 21 As shown, Figure 21 Shown is a schematic structural diagram of a valve repair device in another embodiment of the present application.

[0118] See also Figure 22 , which is a side view of an outer clamping element in one embodiment of the present application. As shown in the figure, in this embodiment, in order to reduce the force used when the first outer clamping arm 141 and the second outer clamping arm 142 are stretched open, the projection point o of the hinge structure 1410 and 1420 at the proximal end of the first outer clamping arm 141 or the second outer clamping arm 142 falls on the outer side of the first outer clamping arm 141 or the second outer clamping arm 142 (as shown in FIG. Figure 19 (shown by the dotted line). In this embodiment, taking the first outer arm 141 as an example, the hinge structure at the distal end of the first outer arm 141 is an outwardly curled hinge structure 1410. The axis of this curling is located outside the projection of the first outer arm 141, thereby providing an optimal fulcrum for the second hinge portion 123. Correspondingly, the hinge structure 1420 at the distal end of the second outer arm 142 has the same structural configuration. In this embodiment, when the first inner arm 121 and the second inner arm 122 support the first outer arm 141 and the second outer arm 142, less force is required.

[0119] exist Figure 22 In the illustrated embodiment, the first outer clamp arm 141 and the second outer clamp arm 142 extend from the distal end 143 toward their proximal end and respectively include a first curved segment a, a second curved segment b, and a third curved segment c; wherein the maximum spacing w1 between the first curved segments a of the first outer clamp arm 141 and the second outer clamp arm 142 is less than the maximum spacing w2 between the second curved segments b; the maximum spacing w1 between the first curved segments a of the first outer clamp arm 141 and the second outer clamp arm 142 is greater than or equal to the minimum spacing w3 between the third curved segments c, that is, w3≤w1<w2.

[0120] See also Figure 23 , showing a side view of the outer clamping element in another embodiment of the present application. As shown in the figure, in this embodiment, the outer clamping element 14 is a U-shaped member, and the first outer clamping arm 141 and the second outer clamping arm 142 extend from the distal end 143 toward the proximal end thereof and respectively include a first bending section a, a second bending section b, and a third bending section c. In this embodiment, the maximum spacing between the first bending section a of the first outer clamping arm 141 and the second outer clamping arm 142 is w1, the maximum spacing between the second bending section b of the first outer clamping arm 141 and the second outer clamping arm 142 is w2, and the minimum spacing between the third bending section c of the first outer clamping arm 141 and the second outer clamping arm 142 is w3, that is, w3≤w1<w2. The implementation method for realizing the above-mentioned spacing relationship is as follows Figure 22 and Figure 23 The two structures shown are a method in which the projection point o of the hinge structure at the proximal end of the first outer clamp arm 141 or the second outer clamp arm 142 falls on the outside of the first outer clamp arm 141 or the second outer clamp arm 142, and a method in which the projection point o of the hinge structure at the proximal end of the first outer clamp arm 141 or the second outer clamp arm 142 falls on the inside of the first outer clamp arm 141 or the second outer clamp arm 142.

[0121] exist Figure 23 In the embodiment shown, in order to increase the mutual clamping force between the first outer clamping arm 141 and the second outer clamping arm 142 under normal conditions, the clamping space formed by the first outer clamping arm 141 and the second outer clamping arm 142 has a smaller opening, that is, the projection point o of the hinge structure at the proximal end of the first outer clamping arm 141 or the second outer clamping arm 142 falls on the inner side of the first outer clamping arm 141 or the second outer clamping arm 142 and falls within the clamping space; in this embodiment, when the first inner clamping arm 121 and the second inner clamping arm 122 support the first outer clamping arm 141 and the second outer clamping arm 142, a greater force is required.

[0122] See also Figure 24 , which is a side view of an outer clamping element in another embodiment of the present application. As shown in the figure, in this embodiment, the first outer clamping arm 141 and the second outer clamping arm 142 extend from the distal end 143 toward their proximal ends and respectively include a curved section a and a straight section d. In this embodiment, the maximum distance between the curved sections a of the first outer clamping arm 141 and the second outer clamping arm 142 is w1, and the maximum distance between the straight sections d of the first outer clamping arm 141 and the second outer clamping arm 142 is also w1. Figure 24 The structure shown.

[0123] See also Figure 25, which is a schematic diagram of the cooperation between the outer clamping element and the drive shaft in one embodiment of the present application. As shown in the figure, the first outer clamping arm 141 and the second outer clamping arm 142 of the outer clamping element 14 are combined into a distal end portion 143 at the distal end. The distal end portion 143 has a screw hole 1431 for screwing the drive shaft 20 of the delivery device. In the initial configuration of the valve repair device, the drive 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 spacer plate 115 and the second spacer plate 116 and is screwed into the screw hole 1431 of the distal end portion 143. When the drive shaft 20 contracts toward the proximal end, it can drive the spacer element 11 to move linearly relative to the distal end portion 143, and then the spacer element 11 drives the first inner clamping arm 121 and the second inner clamping arm 122 hinged at the first hinge portion 113 to move linearly relative to the distal end portion 143. The two inner clamp arms 122 are opened, and 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 hinged on the second hinge part 123. When the first outer clamp arm 141 and the second outer clamp arm 142 with smaller rigidity are stretched to the maximum extent, the distal end of the spacer element 11 connected by the first hinge part 113 and the proximal ends of the first inner clamp arm 121 and the second inner clamp arm 122 approach the distal end 143 of the outer frame assembly. At this time, the first inner clamp arm 121 and the second inner clamp arm 122 are folded so that their proximal ends move close to the distal end 143 of the outer clamp element 14. Due to the elastic restoring force, the first outer clamp arm 141 and the second outer clamp arm 142 force the first and second inner clamp arms 122 on both sides of the inner clamp assembly to respectively adhere to the two sides of the spacer element 11. At this time, the valve repair device is in a closed state, that is, Figure 25 After the operation is completed, the driving shaft 20 of the delivery device is disengaged from the screw hole 1431 by rotation, so that the driving shaft 20 is withdrawn to the valve repair device.

[0124] See also Figure 26 , which is a schematic structural diagram of the outer clamping element in another embodiment of the present application. As shown in the figure, in this embodiment, the distal end 143 of the outer clamping element 14 is an arc-shaped thickened structure or a base structure integrally formed at its bottom.

[0125] In one embodiment, the distal end 143 of the outer clamping element 14 is provided with two axial holes 1432 on either side. In this embodiment, the distal end 143 of the outer clamping element 14 is provided with two side surfaces in the second direction, and each side surface is provided with two axial holes 1432 for pivotally connecting the outer frame components, so that the two outer frame components are rotatably pivotally connected to the distal end 143 of the outer clamping element 14.

[0126] In some embodiments, axial holes 1432 or side through grooves are respectively provided on both sides of the distal end 143 of the outer clamping element 14 .

[0127] See also Figure 27 , which is a schematic diagram of the configuration of the outer frame assembly in the valve repair device in one embodiment of the present application. As shown in the figure, in this embodiment, the valve repair device 1 also includes an outer frame assembly 15 for wrapping with covering material, and 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 both frame structures formed by bending strips. The first outer frame 151 and the second outer frame 152 are rotatably connected to the axial holes 1432 on both sides of the 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 the closed state.

[0128] 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 clamping member.

[0129] See also Figure 28 , which is a schematic diagram of the outer frame structure of the outer frame assembly in one embodiment of the present application, for ease of understanding, Figure 28 There are three state views provided in Figure 28 Figure (a) is a three-dimensional diagram of the outer frame structure. Figure 28 Figure (b) is the front view of the outer frame structure. Figure 28 Figure (c) is a schematic diagram of the first and second outer frames in a closed state. As shown in the figure, in this embodiment, the first outer frame 151 or the second outer frame 152 is bent into a petal structure. It should be understood that the bending into a petal structure means that the bending structure of the first outer frame 151 or the second outer frame 152 presents a structure similar to petals or plant leaves after being wrapped by a covering.

[0130] like Figure 28 As shown, taking the first outer frame 151 as an example, the first outer frame 151 composed of a strip-shaped member includes a first segment L1 extending a first length in the second direction, a second segment L2 extending a second length in the third direction, a third segment L3 bent in an outward-turned shape with a third length, a fourth segment L4 extending a fourth length in the second direction, a fifth segment L5 bent in an outward-turned shape with a third length, a sixth segment L6 extending a second length in the third direction, and a seventh segment L7 extending a first length in the second direction, wherein the length of the first segment L1 is equal to the seventh segment L7, the length of the second segment L2 is equal to the sixth segment L6, and the length of the third segment L3 is equal to the fifth segment L5, the first segment L1 and the seventh segment L7 are axially connected to the axial holes on both sides of the distal end 143 of the outer clamping element 14, the second segment L2, the third segment L3, the fourth segment L4, the fifth segment L5, and the sixth segment L6 constitute a frame structure extending from the axial connection portion toward the proximal end and increasing in width, and the third segment 3 and the fifth segment L5 are outer curved structures formed on the proximal side of the frame structure.

[0131] In an embodiment, the first outer frame 151 and the second outer frame 152 of the outer frame assembly both need to be wrapped with covering material. In order to make the covering material wrapped on its frame body more firm, a folding structure 150 is provided at the proximal end of the frame structure. The folding structure 150 is formed on the fourth section L4 extending the fourth length in the second direction so as to better combine with the covering material.

[0132] In an embodiment, when the first outer frame 151 and the second outer frame 152 of the outer frame assembly cover the first outer clamping arm 141 and the second outer clamping arm 142 in a closed state, the gap between the middle parts of the first outer frame 151 and the second outer frame 152 is no more than 3 mm. Preferably, the gap between the middle parts of the first outer frame 151 and the second outer frame 152 is between 1 mm and 3 mm.

[0133] See also Figure 29 and Figure 30 , Figure 29 This is a schematic diagram showing a closed state of the valve repair device of the present application in one embodiment, which is covered with a covering material. Figure 30 The figure shows a schematic diagram of the valve repair device of the present application in an embodiment of the present invention, which is covered with a covering material in an open state. As shown in the figure, in this embodiment, the valve repair device 1 also includes a covering material 16 for wrapping the spacer element 11, the inner clamp component 12, the clip component 13, the outer clamp component 14, and the outer frame component 15. In an embodiment, the covering material 16 can be configured to prevent or reduce blood flow through the valve repair device and / or to promote natural tissue ingrowth. In an embodiment, when the valve repair device captures and clamps the natural leaflets and is in a closed state, most of the clamped natural leaflets will be wrapped by the covering material 16, thereby reducing the possibility of thrombosis and shortening the time required for endothelialization.

[0134] In some embodiments, the covering material 16 can be a cloth or a woven material, such as PET, velvet, or other suitable woven materials. In other embodiments, instead of a woven material or in addition to a fabric, the covering material 16 may include a coating applied to the valve repair device, the coating being, for example, a polymer (e.g., a natural polymer) or a high molecular material. In an embodiment, the covering material 16 may be coated with or carry a functional drug for accelerating the endothelialization of the valve repair device. In one embodiment, the cloth is, for example, polyethylene cloth. Such as a fine mesh polyethylene cloth, the cloth covering can provide a blood seal on the surface of the spacer and / or promote rapid tissue ingrowth.

[0135] See also Figure 31, showing another embodiment of the valve repair device of the present application, with the covering material being opened. As shown in the figure, in this embodiment, the covering material 16 covering the spacer element 11 and the clip assembly 13 is a one-piece woven braided material; the braided material covering the inner clip assembly 12, the outer clip element 14, and the outer frame assembly 15 is also one-piece woven. The barbs on the clip assembly 13 are exposed through the covering material 16 to capture the valve. In other words, the valve repair device includes two independent woven parts, wherein the spacer element 11 and the first clip 131 and the second clip 132 in the clip assembly 13 are wrapped by a whole piece / block of woven fabric, and the first inner clamp arm 121 and the second inner clamp arm 122 of the inner clamp assembly 12, the first outer clamp arm 141, the second outer clamp arm 142 and the distal end 143 of the outer clamp element 14, and the first outer frame 151 and the second outer frame 152 of the outer frame assembly 15 are wrapped by another whole piece / block of woven fabric, so that each part of the valve repair device has better tensile and fatigue resistance.

[0136] In the present application, the "integrated weaving" means that part of the weaving lines of the woven fabric are continuous and uninterrupted. For example, the woven material wrapped on the inner clamp component 12, the outer clamp element 14, and the outer frame component 15 is integrated weaving, which means that part of the weaving lines of the woven material wrapped on the inner clamp component 12, the outer clamp element 14, and the outer frame component 15 are continuous and uninterrupted, that is, the inner clamp component 12, the outer clamp element 14, and the outer frame component 15 are wrapped by a whole piece or a whole piece of woven fabric, so that not only the woven fabric can improve the sealing effect of covering the internal wrapped elements, but also the wrapped parts have better tensile and fatigue resistance.

[0137] In an embodiment, when the first outer frame 151 and the second outer frame 152 of the outer frame assembly 15 are wrapped in the covering material 16, they form a leaflet structure. The covering space presented by the leaflet structure can enclose the first outer arm 141 or the second outer arm 142, thereby shielding the first outer arm 141 or the second outer arm 142. In this embodiment, the first outer frame 151 and the first outer arm 141 are wrapped together by the covering material 16 so that the first outer frame 151 and the first outer arm 141 are combined into a single unit. The second outer frame 152 and the second outer arm 142 are wrapped together by the covering material 16 so that the second outer frame 152 and the second outer arm 142 are combined into a single unit.

[0138] In an embodiment, when the first inner clamp arm 121 and the second inner clamp arm 122 of the inner clamp assembly 12 are wrapped with the covering material 16, the tongue of the first clamp 131 and the tongue of the second clamp 132 fixed on the first inner clamp arm 121 and the second inner clamp arm 122 are also wrapped together, so that the tongues of the first inner clamp arm 121 and the first clamp 131 are wrapped together and combined into a whole, and the tongues of the second inner clamp arm 122 and the second clamp 132 are wrapped together and combined into a whole.

[0139] In this embodiment, when the spacer element 11 is wrapped in the covering material 16, the ear-shaped engaging blocks on its connecting portion, which are used to engage with the release mechanism of the conveyor device, protrude from the covering material 16 to engage with the release mechanism. In this embodiment, the first spacer plate 115 and the second spacer plate 116 of the spacer element 11 are entirely wrapped in the covering material 16, and the gap between them is concealed by the covering material 16.

[0140] In another embodiment, the valve repair device 1 further comprises a covering material 16 for wrapping the spacer element 11, the inner clip assembly 12, the clip assembly 13, and the outer clip assembly 14. The barbs on the clip assembly 13 are exposed through the covering material 16 to capture the valve. In this embodiment, the covering material 16 wrapping the spacer element 11 and the clip assembly 13 is a braided material that is integrally woven; the braided material wrapping the inner clip assembly 12 and the outer clip assembly 14 is also integrally woven.

[0141] To further describe the inventive concept and principle of this application, please refer to Figures 2 to 4 As shown in the figure, the valve repair device 1 can present multiple state transitions in actual surgical applications, such as an extended state, an open state, and a closed state; when the valve repair device 1 is configured in the delivery catheter / delivery sheath of the conveying device, it is limited to the extended state, the delivery sheath of the conveying device is inserted into the left atrium through the septum, and the valve repair device 1 extends from the delivery sheath to present its extended state. At this time, the connecting portion of the proximal end of the spacer element 11 is engaged with the distal end of the delivery catheter / delivery sheath, and the first inner clamp arm 121 and the second inner clamp arm 122 hinged on the first hinge portion 113 at the distal end of the spacer element 11 are in an approximately fitted state, and the first outer clamp arm 141 and the second outer clamp arm 142 of the outer clamp element 14, which are respectively hinged on the first hinge portion 113 at the distal ends of the first inner clamp arm 121 and the second inner clamp arm 122, are in a normal U-shaped structure because they are free from the limitations of the internal space of the delivery catheter / delivery sheath.

[0142] The valve repair device 1 is delivered to the position of the mitral valve and enters the left ventricle and is partially opened to present an inverted umbrella shape, so that when the clips on the inner clamping arms on both sides are operated to capture the natural valve leaflets, the traction line passing through the distal end of the first clip 131 or the second clip 132 is operated to make the first clip 131 or the second clip 132 open relative to the first inner clamping arm 121 or the second inner clamping arm 122 to capture the natural valve leaflets. At this time, the driving shaft 20 (core rod) of the conveying device is operated to make the spacer element 11 move toward the distal end 143 of the outer clamping element 14 (it can also be understood that the distal end 143 of the outer clamping element 14 moves toward the spacer element 11). Since the first The hinge 113 provides a rotating shaft or pivot structure, allowing the first inner arm 121 and the second inner arm 122 hinged to the first hinge 113 to simultaneously expand toward both sides (outwards). Accordingly, the first clip 131 and the second clip 132, respectively fixed to the first inner arm 121 and the second inner arm 122, also expand toward both sides (outwards) along with the first inner arm 121 and the second inner arm 122. Due to the rotating shaft or pivot provided by the U-shaped first outer arm 141 and the second outer arm 142 at the second hinge 123 and their inherent stiffness (third stiffness), the first outer arm 141 and the second outer arm 142 are gradually expanded until they reach their maximum expansion range. At this point, the valve repair device 1 is in an open state, resembling an umbrella.

[0143] By operating the driving shaft 20 (core rod) of the conveying device, the spacer element 11 continues to move toward the distal end 143 of the outer clamping element 14, and the distal end of the spacer element 11 enters the clamping space formed by the first outer clamping arm 141 and the second outer clamping arm 142 of the U-shaped structure and gradually approaches the distal end 143 of the outer clamping element 14. At this time, the proximal and distal ends of the first inner clamping arm 121 and the second inner clamping arm 122, one end of which is hinged to the first hinge part 113 and the other end of which is hinged to the second hinge part 123, are interchanged. In this process, the first clamp 131 and the second clamp 132 are released by controlling the traction line, so that the natural valve on one side is clamped between the first clamp 131 and the first inner clamping arm 121, and the natural valve on the other side is clamped between the second clamp 132 and Between the second inner clamp arm 122, as the spacer element 11 continues to move downward, the first inner clamp arm 121 and the second inner clamp arm 122 are retracted inward (toward the central axis of the spacer element 11). At this time, due to the flipping of the first inner clamp arm 121 and the second inner clamp arm 122, the supporting force on the first outer clamp arm 141 and the second outer clamp arm 142 is reduced. The first outer clamp arm 141 and the second outer clamp arm 142 are then clamped toward each other by their own elastic restoring force, thereby positioning the spacer element 11, the clip assembly 13, and the inner clamp assembly 12 in the clamping space. Moreover, due to the elasticity of the first outer clamp arm 141 and the second outer clamp arm 142 themselves, the components / elements in the clamping space are maintained with a clamping force toward each other, so that the valve repair device 1 is in a closed state.

[0144] At this time, the driving shaft 20 of the operating delivery device is disengaged from the screw hole 1431 of the outer clamping element 14, and then the release structure at the distal end of the delivery catheter / delivery sheath of the operating delivery device is pulled out to release the engagement of the ear-shaped block on the spacer element 11, and the traction line is pulled out from the traction holes of the first clip 131 and the second clip 132, so that the valve repair device 1 is maintained on the natural valve, thereby completing the partial closure of the natural valve.

[0145] The valve repair device provided by the present application adopts two hinge structures to hinge the spacer element and the inner clamping assembly at the first place, and hinge the inner clamping assembly and the outer clamping element with a U-shaped structure at the second place. Compared with the related art (such as the valve repair clamp disclosed in Chinese Patent Publication No. CN111449805A), which only adopts one hinge structure and the other adopts a folding structure, the two hinge structures have better flexibility. The present application requires less force when the drive shaft drives the spacer element to move toward the distal end of the outer clamping element, which is beneficial to the doctor's precision control during operation; furthermore, the present application adopts an integrally formed U-shaped outer clamping element, utilizing The rigidity design of its outer clamping arm continuously maintains the opposite clamping force on each component / element in the clamping space, and has more stable performance compared with the mechanical locking used to ensure the clamping effect in the related art. In addition, the present application uses an integrally formed U-shaped outer clamping element to provide a structurally simpler clamping method, which has a more stable clamping effect compared with the elastic clamping force provided by the frame / strip in the related art. Moreover, compared with the outer and inner clamping arms formed by folding metal braided materials in the prior art (such as the braided mesh valve repair clamp disclosed in Chinese Patent Publication No. CN112402061A), it has a simpler preparation process.

[0146] The above embodiments are merely illustrative of the principles and effects of this application and are not intended to limit this application. Anyone skilled in the art may modify or alter the above embodiments without departing from the spirit and scope of this application. Therefore, all equivalent modifications or alterations made by one of ordinary skill in the art without departing from the spirit and technical concepts disclosed in this application shall be covered by the claims of this application.

Claims

1. A valve repair device, characterized in that: include: The spacer element comprises a spacer having a first rigidity, wherein a proximal end of the spacer is provided with a connecting portion for connecting to a delivery device, and opposite sides of a distal end of the spacer are respectively provided with first hinge portions; The inner clamp assembly comprises a first inner clamp arm and a second inner clamp arm, each having a second rigidity, wherein the proximal ends of the first inner clamp arm and the second inner clamp arm are respectively hinged to the first hinge portion; and the distal ends of the first inner clamp arm and the second inner clamp arm are respectively provided with a second hinge portion; a clip assembly, disposed on the inner clip assembly or hinged to the first hinged portion, comprising a first clip that can be opened or closed relative to the first inner clip arm, and a second clip that can be opened or closed relative to the second inner clip arm, wherein the distal ends of the first clip and the second clip are respectively provided with a traction portion; The outer clamping element comprises a distal end portion and a first outer clamping arm and a second outer clamping arm integrally formed with the distal end portion; the proximal ends of the first outer clamping arm and the second outer clamping arm are respectively hinged to the second hinge portion; the first outer clamping arm and the second outer clamping arm each have a third stiffness; a clamping space is formed between the first outer clamping arm and the second outer clamping arm, and when the spacer element, the clip assembly, and the inner clamping assembly are located in the clamping space, the first outer clamping arm and the second outer clamping arm maintain a clamping force toward each other; The first outer clamping arm or the second outer clamping arm has a structure with increasing width from the proximal end toward the distal end, and the distal end of the outer clamping element is an arc-shaped thickened structure or a base structure integrally formed at its bottom.

2. The valve repair device according to claim 1, characterized in that: The stiffness of the spacer element as a whole is defined as a first stiffness; the first stiffness is greater than or equal to the second stiffness, and the second stiffness is greater than the third stiffness.

3. The valve repair device according to claim 1, characterized in that: The stiffness of the spacer element as a whole is defined as a first stiffness; the first stiffness is smaller than the second stiffness, and the second stiffness is larger than the third stiffness.

4. The valve repair device according to claim 1, characterized in that: The first clip or the second clip has a fourth stiffness that is smaller than the third stiffness.

5. The valve repair device according to claim 1, characterized in that: The overall stiffness of the first outer clamp arm or the second outer clamp arm is defined as a third stiffness, and the stiffness distribution of the first outer clamp arm or the second outer clamp arm adjacent to the proximal end is smaller than the stiffness distribution adjacent to the distal end.

6. The valve repair device according to claim 1, characterized in that: The spacer element includes, from the proximal end to the distal end, a connecting head, a neck, a first spacer plate and a second spacer plate separated from the neck and extending toward the distal end, and a hinge structure formed at the distal ends of the first spacer plate and the second spacer plate respectively. The connecting head, neck, first spacer plate and second spacer plate, and the hinge structure are integrally formed.

7. The valve repair device according to claim 6, characterized in that: When the spacer element, the clip assembly, and the inner clip assembly are located in the clamping space, the connecting head is higher than the height of the clip assembly, the inner clip assembly, or the outer clip element.

8. The valve repair device according to claim 6, characterized in that: The connecting head of the spacer element is fixed with the connecting portion, and the opposite sides of the connecting portion respectively have ear-shaped blocks for engaging the conveying device; the connecting portion and the connecting head are provided with through holes for the driving shaft of the conveying device to pass through.

9. The valve repair device according to claim 8, characterized in that: The extension directions of the ear-shaped clamping blocks on both sides of the connecting portion are parallel to the plate surfaces of the first partition plate and the second partition plate.

10. The valve repair device according to claim 6, characterized in that: The neck portion includes a bridge structure for separating the first partition plate and the second partition plate, wherein a width of the bridge structure in a first direction is greater than a maximum separation width between the first partition plate and the second partition plate; The width of the bridge structure in the second direction is smaller than the maximum width of the first spacer plate or the second spacer plate.

11. The valve repair device according to claim 6, characterized in that: A gap is defined between distal ends of the first partition plate and the second partition plate for the driving shaft of the conveying device to pass through.

12. The valve repair device according to claim 6, characterized in that: The distal ends of the first partition plate and the second partition plate are connected to each other, and a through hole for the driving shaft of the conveying device to pass through is formed at the connection.

13. The valve repair device according to claim 6, characterized in that: The distal end of the first partition plate or the second partition plate forms a hinge structure consisting of two separate and outwardly curled hinge structures.

14. The valve repair device according to claim 6, characterized in that: The hinge structure formed at the distal end of the first partition plate or the second partition plate is an outwardly curled hinge structure, wherein the hinge structure of the first partition plate and the hinge structure of the second partition plate are staggered with each other.

15. The valve repair device according to claim 6, characterized in that: The maximum widths of the first hinge portion of the first partition plate and the first hinge portion of the second partition plate in the first direction are not greater than the maximum width of the connecting portion of the partition element in the first direction.

16. The valve repair device according to claim 6, characterized in that: The plate body of the first partition plate or the second partition plate has a structure with decreasing width toward the hinge structure at the distal end thereof.

17. The valve repair device according to claim 1, characterized in that: The plate thickness of the first inner clamp arm or the second inner clamp arm is greater than the plate thickness of the first partition plate or the second partition plate; the plate thickness of the first inner clamp arm or the second inner clamp arm is greater than the plate thickness of the first outer clamp arm and the second outer clamp arm.

18. The valve repair device according to claim 1, characterized in that: The proximal end of the first inner clamp arm or the second inner clamp arm has a hinge structure that curls outward; the distal end of the first inner clamp arm or the second inner clamp arm has a hinge structure that curls inward.

19. The valve repair device according to claim 1, characterized in that: The hinge structure at the proximal end of the first inner arm or the second inner arm and the hinge structure at the distal end are staggered along the direction of the plate body; or the hinge structure at the proximal end of the first inner arm or the second inner arm and the hinge structure at the distal end are aligned with each other along the direction of the plate body.

20. The valve repair device according to claim 1, characterized in that The plate body adjacent to the proximal end of the first inner clamp arm or the second inner clamp arm has an opening for passing the first clamp or the second clamp, so that a portion of the first clamp or the second clamp passes through the opening from one side of the plate body and is combined to the other side.

21. The valve repair device according to claim 1, characterized in that: A limiting block is provided on the plate body adjacent to the distal end of the first inner clamp arm or the second inner clamp arm, for maintaining the distance between the first clamp piece or the second clamp piece and the first inner clamp arm or the second inner clamp arm.

22. The valve repair device according to claim 1, characterized in that: The plate body of the first inner clamp arm or the second inner clamp arm is provided with a fixing hole for welding or riveting the first clamp piece or the second clamp piece.

23. The valve repair device according to claim 1, characterized in that: The plate body of the first inner clamp arm or the second inner clamp arm is provided with puncture holes or puncture grooves corresponding to the barbs on the first clamp piece or the second clamp piece.

24. The valve repair device according to claim 1, characterized in that The traction portion at the distal end of the first clip or the second clip is a traction hole for passing a traction line.

25. The valve repair device according to claim 24, characterized in that: The traction hole is formed on the body of the first clip or the second clip; or the traction hole is a perforated structure formed at the distal end of the first clip or the second clip and curled outward.

26. The valve repair device according to claim 1, characterized in that The body of the first clip or the second clip has at least one pair of notch structures.

27. The valve repair device according to claim 1, characterized in that The proximal end of the first clip or the second clip has a hinge structure for being hinged to the first hinge portion.

28. The valve repair device according to claim 1, characterized in that The proximal end of the first clip or the second clip has an elastic structure.

29. The valve repair device according to claim 1, characterized in that A bending structure is formed near the proximal end portion of the first clip or the second clip to form a preset distance between the surface of the first clip or the second clip and the surface of the first inner clip arm or the second inner clip arm.

30. The valve repair device according to claim 1, characterized in that The first clip or the second clip is a double-layer spring sheet including an inner spring sheet and an outer spring sheet, the inner spring sheet is provided with barbs, the outer spring sheet fits the inner spring sheet, and the inner spring sheet and the outer spring sheet are combined at the proximal end.

31. The valve repair device according to claim 30, characterized in that: The outer layer spring piece is a hollow structure.

32. The valve repair device according to claim 1, characterized in that The outer clamping element is a U-shaped element, and the distal ends of the first outer clamping arm or the second outer clamping arm are integrated into one at the distal end of the U-shaped element.

33. The valve repair device according to claim 1, characterized in that The hinge structure formed at the proximal end of the first outer clamp arm or the second outer clamp arm is two separate and outwardly curled hinge structures.

34. The valve repair device according to claim 1, characterized in that The proximal end and the distal end of the first outer clamp arm or the second outer clamp arm have the same width.

35. The valve repair device according to claim 1, characterized in that The hinge structure formed at the proximal end of the first outer clamp arm or the second outer clamp arm is an outwardly curled hinge structure, and the hinge structures of the first outer clamp arm and the second outer clamp arm are staggered with each other.

36. The valve repair device according to claim 1, characterized in that The projection point of the hinge structure at the proximal end of the first outer clamp arm or the second outer clamp arm falls on the outer side of the first outer clamp arm or the second outer clamp arm.

37. The valve repair device according to claim 1, characterized in that The first outer clamping arm or the second outer clamping arm has a structure with increasing thickness from the proximal end toward the distal end.

38. The valve repair device according to claim 1, characterized in that The first outer clamp arm and the second outer clamp arm extend from the distal end toward the proximal end thereof and respectively include a first curved section, a second curved section, and a third curved section; wherein the maximum distance between the first curved sections of the first outer clamp arm and the second outer clamp arm is smaller than the maximum distance between the second curved sections; the maximum distance between the first curved sections of the first outer clamp arm and the second outer clamp arm is greater than or equal to the minimum distance between the third curved sections.

39. The valve repair device according to claim 1, characterized in that The first outer clamp arm and the second outer clamp arm extend from the distal end toward the proximal end thereof and respectively include a curved section and a straight section.

40. The valve repair device according to claim 1, characterized in that The distal end portion of the outer clamping element has a screw hole for screwing a driving shaft of a delivery device.

41. The valve repair device according to claim 1, characterized in that Axial holes are respectively provided on both sides of the distal end portion of the outer clamping element.

42. The valve repair device according to claim 1, characterized in that It also includes an outer frame component for being wrapped with covering material, and the outer frame component includes a first outer frame and a second outer frame respectively axially connected to the opposite sides of the distal end of the outer clamping element, and the first outer frame or the second outer frame is bent into a leaflet structure so as to cover the first outer clamping arm or the second outer clamping arm respectively in the closed state.

43. The valve repair device according to claim 42, characterized in that: The first outer frame or the second outer frame includes an axial connection portion for axially connecting to both sides of the distal end of the outer clamping element, and a frame structure extending from the axial connection portion toward the proximal end and increasing in width, wherein the frame structure has a proximal end with an outer side bent.

44. The valve repair device according to claim 42, characterized in that The proximal end of the frame structure has a folded edge structure.

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