Valve Repair Device and System and Operating Method

Abstract

The present invention relates to a valve repair device, system, and operation method. The valve repair system includes a conveying device and a valve repair device. The valve repair device includes a clamping component, an anchoring component, and a support component. The anchoring component is arranged outside the clamping component and connected to the clamping component. The support component is at least partially arranged inside the clamping component and connected to the clamping component. The valve repair device can be switched between a closed state and a captured state. In the closed state, the axial height of the clamping component is higher than the axial height of the support component, and the inner clamping length of the clamping component in the closed state is greater than the inner clamping length of the clamping component in the captured state. The pushing component of the conveying device is respectively connected to the proximal end and the distal end of the clamping component. The control wire of the conveying device is connected to the anchoring component. The conveying device can control the valve repair device to switch between different states. The valve repair device of the present invention can meet the requirements of a small capture space and a long closed clamping length.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to a valve repair device, system and operation method. Background Art

[0002] Heart valves are membranous structures that open and close in humans and certain animals. Each heart has four valves: the aortic valve, which connects the left ventricle to the aorta; the pulmonary valve, which connects the right ventricle to the pulmonary artery; the mitral valve, which connects the left atrium to the left ventricle; and the tricuspid valve, which connects the right atrium to the right ventricle. Heart valves separate the atria from the ventricles, preventing blood from flowing back into the atria. They allow blood from the ventricles to flow through the aortic or pulmonary valves into the aorta or pulmonary artery, allowing oxygen-rich blood to flow through the aorta to the body. Blood collected by the superior and inferior vena cava is then transferred to the lungs for oxygen exchange, becoming oxygen-rich arterial blood. Heart valves act like check valves, preventing blood from flowing in one direction but preventing reverse flow. If a valve does not close properly, reverse flow can occur, preventing blood from fully entering the aorta or pulmonary artery, leading to heart failure and impairing quality of life. Severe reverse flow can even be life-threatening.

[0003] With socioeconomic development and an aging population, the incidence of valvular heart disease has increased significantly. Studies have shown that the prevalence of valvular heart disease in the elderly over 75 years old is as high as 13.3%. Furthermore, due to ethnic differences, the complications and causes of valvular heart disease in China differ from those in other countries. The patient profiles of valvular heart disease vary across different regions of China, leading to varying device requirements for complex complications. Currently, mitral valve disease is the most common complication among valvular heart disease patients, primarily characterized by mitral regurgitation. The number of patients with tricuspid regurgitation is also increasing.

[0004] Transcatheter mitral or tricuspid valve repair has attracted widespread attention from experts and scholars due to its advantages, including the absence of a thoracotomy, minimal trauma, and rapid patient recovery. Existing transcatheter mitral or tricuspid valve repair devices typically utilize an elastic clip to clamp the mitral or tricuspid valve leaflets to achieve edge-to-edge repair. The elastic clip utilizes the elastic force of the elastic element itself to achieve a tight clamping force, thereby suppressing mitral or tricuspid regurgitation and achieving a therapeutic effect for mitral or tricuspid regurgitation. However, the surgical procedure is difficult due to the limited operating space and the complex native structure, including the leaflets, annulus, chordae tendineae, papillary muscles, and myocardium. The mitral and tricuspid valves have similar structures, but the tricuspid valve has a smaller operating space than the mitral valve, requiring the valve repair device to have the smallest possible dimensions in both the extended (i.e., delivery) and captured states. However, paradoxically, as the size of the valve repair device decreases, the length of the valve clamp also decreases. The longer a valve repair device grips the valve, the more secure and effective the anchoring, and the more effective it is in treating regurgitation. The configuration of existing valve repair devices creates a positive correlation between their capture space (the deployed capture state) and their grip length (the closed grip state). These two change in the same direction, making it impossible to balance the practical requirements of a small capture space with a long grip length.

[0005] It should be noted that the information disclosed in the background technology section of this application is only intended to deepen the understanding of the general background technology of this application, and should not be regarded as an admission or any form of implication that the information constitutes prior art already known to those skilled in the art. Summary of the Invention

[0006] The object of the present invention is to provide a valve repair device, system and method of use to solve the problem that the existing valve repair device cannot meet the requirements of small capture space and long closed clamping length.

[0007] To achieve the above-mentioned object, according to one aspect of the present invention, a valve repair device is provided, comprising a clamping component, an anchoring component, and a support component; the anchoring component is disposed outside the clamping component and connected to the clamping component; the anchoring component is used to cooperate with the clamping component to clamp the native valve; the support component is at least partially disposed inside the clamping component and connected to the clamping component; the support component is capable of elastically supporting the clamping component to maintain the shape of the valve repair device;

[0008] The valve repair device has a closed state and a captured state, and can be switched between the closed state and the captured state. In the closed state, the axial height of the clamping part is higher than the axial height of the support part, and the inner clamping length of the clamping part in the closed state is greater than the inner clamping length of the clamping part in the captured state.

[0009] Optionally, the clamping component includes a first clamping arm, a third clamping arm, and a second clamping arm connected in sequence, the proximal end of the first clamping arm is connected to the proximal end of the clamping component, and the distal end of the second clamping arm is connected to the distal end of the clamping component; the anchoring component is located on a side of the first clamping arm away from the second clamping arm, and is fixedly connected to the first clamping arm; the proximal end of the support component is movably connected to the first clamping arm or the second clamping arm, and the distal end of the support component is fixedly connected to the distal end of the clamping component;

[0010] The third clamping arm can change its position between a closed state and a captured state so that the inner clamping length of the clamping part in the closed state is the sum of the length of the third clamping arm and the length of the first clamping arm, and the inner clamping length of the clamping part in the captured state is the length of the first clamping arm.

[0011] Optionally, the stiffness of the third clamping arm is smaller than the stiffness of the first clamping arm and the stiffness of the second clamping arm.

[0012] Optionally, the valve repair device further comprises a connecting component, and the proximal end of the support component is flexibly connected to the first clamping arm or the second clamping arm via the connecting component, and the connecting component is at least one of a suture, a flexible flange, a flexible clamp and a spring.

[0013] Optionally, the valve repair device further comprises a spacer portion, and the number of the clamping parts is multiple, and the multiple clamping parts are arranged along the circumference of the spacer portion, the distal end of the spacer portion is connected to the first clamping arms of all the clamping parts, and the anchoring part is located between the spacer portion and the first clamping arm.

[0014] Optionally, the valve repair device further includes a joint component, which includes a proximal connector and a distal connector, the proximal connector is connected to the proximal end of the spacer, and the distal end of the second clamping arm and the distal end of the support component are both connected to the distal connector; the joint component is used to be detachably connected to the conveying device, and can move axially along the valve repair device under the operation of the conveying device, thereby controlling the valve repair device to switch between different states.

[0015] Optionally, the distal connecting member includes a first connecting member and a second connecting member that are coaxially connected, the second connecting member is arranged on the proximal side of the first connecting member, and the distal end of the support component passes through and is fixed in the first connecting member and the second connecting member.

[0016] Optionally, the pillar component is composed of a plurality of support members, and the plurality of support members are arranged along the circumference of the valve repair device, and / or the anchoring component includes an anchoring portion, and the anchoring portion includes an anchoring plate and a support plate, and the support plate is fixedly arranged on a side of the first clamping arm close to the anchoring portion, and one end of the anchoring plate is elastically connected to the support plate.

[0017] To achieve the above-mentioned object, according to another aspect of the present invention, a valve repair system is provided, comprising a delivery device and any one of the valve repair devices described above, wherein the delivery device comprises a control wire and a pushing component; the control wire is detachably connected to the anchoring component to control the opening and closing of the anchoring component; the pushing component is detachably connected to the proximal end and the distal end of the clamping component to control the switching of the state of the valve repair device;

[0018] When the proximal and distal ends of the clamping component are manipulated by the pushing component to move axially relative to each other, the clamping component can change the clamping length between the closed state and the captured state, and make the axial height of the clamping portion in the closed state higher than the axial height of the support component, thereby making the inner clamping length of the clamping component in the closed state greater than the inner clamping length of the clamping component in the captured state.

[0019] Optionally, the clamping component includes a first clamping arm, a third clamping arm, and a second clamping arm connected in sequence, the proximal end of the first clamping arm is connected to the proximal end of the clamping component, and the distal end of the second clamping arm is connected to the distal end of the clamping component; the anchoring component is located on a side of the first clamping arm away from the second clamping arm, and is fixedly connected to the first clamping arm; the proximal end of the support component is movably connected to the first clamping arm or the second clamping arm, and the distal end of the support component is fixedly connected to the distal end of the clamping component;

[0020] When the valve repair device is manipulated by the delivery device to switch from the captured state to the closed state, the third clamping arm moves from the position of the second clamping arm to the position of the first clamping arm until it moves to a position collinear with the first clamping arm, thereby making the inner clamping length of the clamping component in the closed state the sum of the length of the third clamping arm and the length of the first clamping arm;

[0021] During the process of the valve repair device being manipulated by the conveying device to switch from a closed state to a captured state, the third clamping arm moves from the position of the first clamping arm to the position of the second clamping arm until it moves to a position collinear with the second clamping arm, thereby making the inner clamping length of the clamping part in the captured state the length of the first clamping arm.

[0022] Optionally, the pushing component includes a pushing tube and a pushing wire, and the valve repair device also includes a joint component, the joint component includes a proximal connecting piece and a distal connecting piece, the proximal connecting piece is arranged at the proximal end of the clamping component, and the distal connecting piece is arranged at the distal end of the clamping component, the distal end of the pushing tube is detachably connected to the proximal connecting piece, and the distal end of the pushing wire is detachably connected to the distal connecting piece after passing through the pushing tube and the proximal connecting piece in sequence.

[0023] To achieve the above object, according to another aspect of the present invention, a method for operating a valve repair device is provided, for controlling any one of the valve repair devices to switch between different states through a delivery device, the method comprising:

[0024] Connecting a control wire of the delivery device to the anchoring component, and controlling the opening and closing of the anchoring component by the control wire;

[0025] Connecting the pushing components of the conveying device to the proximal end and the distal end of the clamping component respectively, and controlling the opening and closing of the clamping component by the pushing components;

[0026] In which, during the process of the pushing component manipulating the proximal and distal ends of the clamping component to move axially relative to each other, the proximal end of the pillar component produces a certain displacement relative to the clamping component, so that the clamping component can change the clamping length between the closed state and the captured state, and the axial height of the clamping component in the closed state is higher than the axial height of the pillar component, thereby making the inner clamping length of the clamping component in the closed state greater than the inner clamping length of the clamping component in the captured state.

[0027] Optionally, the method for switching the valve repair device from the captured state to the closed state comprises the following steps:

[0028] The pushing component manipulates the proximal end and the distal end of the clamping component to move relatively close to each other, drives the proximal end of the support component to move relative to the first clamping arm or the second clamping arm, and drives the third clamping arm to move from the position of the second clamping arm to the position of the first clamping arm, until the third clamping arm moves to a position collinear with the first clamping arm, thereby making the inner clamping length of the clamping component in the closed state the sum of the length of the third clamping arm and the length of the first clamping arm;

[0029] The method for switching the valve repair device from the closed state to the captured state comprises the following steps:

[0030] The pushing component manipulates the proximal and distal ends of the clamping component to be relatively close, drives the proximal end of the pillar component to move relative to the first clamping arm or the second clamping arm, and drives the third clamping arm to move from the position of the first clamping arm to the position of the second clamping arm until the third clamping arm moves to a position collinear with the second clamping arm, thereby making the inner clamping length of the clamping component in the captured state the length of the first clamping arm.

[0031] The valve repair device provided by the present invention comprises: a clamping part, an anchoring part and a pillar part; the anchoring part is arranged on the outside of the clamping part and is connected to the clamping part; the anchoring part is used to cooperate with the clamping part to clamp the native valve together; the pillar part is at least partially arranged inside the clamping part and is connected to the clamping part; the pillar part can elastically support the clamping part to maintain the shape of the valve repair device; the valve repair device has a closed state and a captured state, and can be switched between the closed state and the captured state. In the closed state, the clamping part The axial height of the closing component is higher than the axial height of the support component, and the inner clamping length of the clamping component in the closed state is greater than the inner clamping length of the clamping component in the capturing state, which makes the length of the valve repair device clamping the valve in the closed state longer, making the anchoring more firm and the reflux treatment effect better. Because the inner clamping length of the clamping component in the capturing state can be shorter than the inner clamping length of the clamping component in the closed state, the capture space of the valve repair device in the capturing state is reduced, and the space occupied in the heart is also small. Therefore, within the limited operating space, the operation is safer and more effective.

[0032] In the valve repair system provided by the present invention, the states of the valve repair device can be switched by cooperating with a pusher component and a control wire. The valve repair system and operating method provided by the present invention are based on the same inventive concept as the valve repair device provided by the present invention. Therefore, the valve repair system and operating method provided by the present invention possess all the advantages of the valve repair device provided by the present invention. Therefore, the beneficial effects of the valve repair system and operating method provided by the present invention will not be elaborated on here. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Those skilled in the art will appreciate that the accompanying drawings are provided for a better understanding of the present invention and do not constitute any limitation on the scope of the present invention.

[0034] Figure 1 is a schematic diagram of a valve repair device according to an embodiment of the present invention in a closed state;

[0035] Figure 2 is a schematic diagram of a valve repair device according to an embodiment of the present invention in a capturing state;

[0036] Figure 3 This is a partial schematic diagram of the valve repair device according to an embodiment of the present invention, in which the length of the valve being clamped becomes longer in the closed state;

[0037] Figure 4 is a partial schematic diagram of the valve repair device according to an embodiment of the present invention, in which the capture space is reduced in the capture state;

[0038] Figure 5 This is a diagram of an application scenario of the valve repair device according to an embodiment of the present invention, clamping the valve to reduce regurgitation in the closed state. The inner clamping length is L1 + L2 (for unilateral clamping). L1 is the length of the first clamping arm, which is equivalent to the length of the anchoring component. L2 is the length of the third clamping arm.

[0039] Figure 6 is a structural schematic diagram of an anchoring portion according to an embodiment of the present invention;

[0040] Figure 7 2. It is a schematic structural diagram of an elastic pressure ring according to an embodiment of the present invention;

[0041] Figure 8 This is a diagram of an application scenario of the valve repair system according to an embodiment of the present invention when repairing a mitral valve;

[0042] Figure 9 2 is a diagram of an application scenario of the valve repair device of the comparative embodiment clamping the valve to reduce regurgitation in the closed state, wherein the inner clamping length is L1 (in terms of unilateral clamping);

[0043] Figure 10 is a schematic diagram of a valve repair device of a comparative embodiment in a capturing state with a larger capturing space;

[0044] Figure 11 This is a schematic structural diagram of three clamping arms connected in sequence according to an embodiment of the present invention;

[0045] Figure 12 is a schematic diagram of the positions of the three clamping arms in the closed state according to an embodiment of the present invention;

[0046] Figure 13 is the movement state of the third clamping arm during the process of switching from the closed state to the captured state in the embodiment of the present invention;

[0047] Figure 14 Schematic diagram of the positions of the three clamping arms in the capturing state according to an embodiment of the present invention.

[0048] In the attached figure:

[0049] 1-proximal connector; 2-clamping component; 221-first clamping arm; 222-second clamping arm; 223-third clamping arm; 4-pillar component; 41-supporting member; 42-elastic pressure ring; 42a-distal end of the elastic pressure ring; 42b-proximal end of the elastic pressure ring; 5-anchoring component; 51-anchoring portion; 511-anchoring plate; 512-supporting plate; 6-distal connector; 61-first connector; 62-second connector; 7-spacer; L1-length of the first clamping arm; L2-length of the third clamping arm; H1-axial height of the clamping component; H2-axial height of the pillar component; a, b-schematic points; A-axis line of the valve repair device; 10-native valve; 20-control wire; 30-pushing component; 31-pushing wire; 32-pushing tube; 40-delivery sheath. DETAILED DESCRIPTION

[0050] The technical solution of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the embodiments described are only some embodiments of the present invention, not all embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention without making any creative efforts shall fall within the scope of protection of the present invention.

[0051] In the description of the present invention, it should be noted that the terms "center", "up", "down", "left", "right", "vertical", "horizontal", "inside", "outside", etc., indicating directions or positional relationships, are based on the directions or positional relationships shown in the accompanying drawings. They are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific direction, be constructed and operated in a specific direction. Therefore, they cannot be understood as limiting the present invention.

[0052] In the description of this invention, it is important to note that the terms "proximal end" and "distal end" are defined as follows: "proximal end" generally refers to the end of a medical device that is closest to the operator during normal operation, while "distal end" generally refers to the end of a medical device that is farther from the operator during normal operation. "Distal end" and "proximal end" in this application document do not refer to ends of structures, but rather to relative positions. For example, the distal end of a clamping component is not the end of the clamping component, but rather a position relatively close to the end of the clamping component.

[0053] In the description of the present invention, it should be noted that, unless otherwise expressly specified or limited, the terms "mounted," "connected," and "connected" should be understood in a broad sense. For example, they may refer to fixed, detachable, or integral connections; mechanical or electrical connections; direct or indirect connections through an intermediate medium; and internal communication between two components. Those skilled in the art will understand the specific meanings of the above terms in the present invention based on the specific circumstances.

[0054] As used herein, "circumferential" refers to the direction around the axis of the valve repair device or the clamping component, "axial" refers to the direction along the axis of the valve repair device or the clamping component, and "transverse" refers to the direction perpendicular to the axis of the valve repair device or the clamping component, that is, the diameter direction or the width direction. As used herein, "inner side" refers to the side close to the axis of the valve repair device or the clamping component, or the side that directly contacts the native valve; "outer side" refers to the side farther away from the axis of the valve repair device or the clamping component than the "inner side", or the side that does not contact the native valve; "axial height" mainly refers to the height of the valve repair device in the axial direction in the closed state, including the axial height of the clamping component in the closed state and the axial height of the strut component in the closed state.

[0055] The core idea of the present invention is to provide a valve repair device, system and operation method to solve the problem that the existing valve repair device cannot meet the requirements of small capture space and long closed clamping length.

[0056] The valve repair device, system and operation method provided by the present invention can be applied to the repair of various heart valves, such as the mitral valve, tricuspid valve, aortic valve or pulmonary valve, and is particularly suitable for repairing valves with small operating space, such as the tricuspid valve.

[0057] The valve repair device, system, and operating method provided by the present invention meet the practical requirements of a small capture space and a long closure and clamping length. Because of the small capture space, the valve repair device occupies less space in the heart, thereby improving operational safety and effectiveness within the limited operating space. Furthermore, the longer closure and clamping length improves the anchoring of the valve repair device, resulting in more effective reflux treatment.

[0058] The following description will be made with reference to the accompanying drawings. Unless there is any conflict, the following embodiments and features of the embodiments may complement or be combined with each other.

[0059] Figure 1 and Figure 2 This is an exemplary embodiment of the valve repair device of the present invention. Figure 1 and Figure 2 As shown, the valve repair device provided by the embodiment of the present invention includes a clamping component 2, a support component 4 and an anchoring component 5. The anchoring component 5 is arranged outside the clamping component 2 and connected to the clamping component 2. Figure 5As shown, the anchoring member 5 cooperates with the clamping member 2 to clamp the native valve 10. The support member 4 is at least partially disposed inside the clamping member 2 and connected to the clamping member 2. It should be understood that as the state of the valve repair device changes, the position of the proximal end of the support member 4 relative to the clamping member 2 and the anchoring member 5 will change; for example, when the valve repair device is in the captured state, the support member 4 can be completely located inside the clamping member 2 (see FIG. Figure 2 ); During the process of switching the valve repair device to the closed state, the proximal end of the support member 4 can move relative to the clamping member 2 and the anchoring member 5, so that the proximal end of the support member 4 is located outside the clamping member 2 (see Figure 1 The support member 4 can apply a force to the clamping member 2, elastically supporting the clamping member 2 and thereby maintaining the shape of the valve repair device, such as enabling the clamping member 2 to converge and extend during the repair process. Therefore, the valve repair device of the present application has at least a closed state and a captured state, and is further capable of switching between the closed state and the captured state.

[0060] The valve repair device of the present application is also capable of changing the clamping length of the clamping part 2 between the closed state and the capture state, and the clamping length includes the inner clamping length. The inner clamping length described herein refers to the length of the clamping surface on one side of the native valve that directly contacts the native valve, and the inner clamping length should include the closed clamping length in the closed state (that is, the length of the valve clamped when closed) and the capture length in the capture state. The closed clamping length proposed in the present application can change in the opposite direction to the capture space, that is, when the closed clamping length becomes longer, the capture space can become smaller, and conversely, when the capture space becomes smaller, the closed clamping length can become longer, thereby solving the current problem that the closed clamping length and the capture space can only change in the positive direction.

[0061] like Figure 1 and Figure 3 As shown, in the closed state, the axial height H1 of the clamping part 2 is higher than the axial height H2 of the support part 4, thereby making the inner clamping length of the clamping part 2 (for single-sided clamping) L1+L2. Figure 2 and Figure 4As shown, in the capture state, the inner clamping length of the clamping component 2 (for unilateral capture) is L1. In other words, the inner clamping length (L1+L2) of the clamping component 2 in the closed state is greater than the inner clamping length (L1) of the clamping component 2 in the capture state. This allows the valve repair device to clamp the native valve 10 longer in the closed state, making the anchoring more secure and the regurgitation treatment more effective. It also reduces the capture space of the valve repair device in the capture state, thereby reducing the space occupied in the heart. Therefore, within the limited operating space, the operation is safer and more effective. It should be noted that the inner clamping length of the clamping component 2 in the capture state is the inner capture length when deployed. The inner capture length determines the transverse profile size (i.e., the capture space) of the valve repair device when deployed. The smaller the inner capture length, the smaller the transverse profile size, and the corresponding smaller the capture space.

[0062] It should also be understood that, in addition to the illustrated state, the valve repair device also has a delivery sheath 40 (see Figure 8 ) during delivery (stretched to present a smaller profile). The valve repair device can be implanted via a catheter. After the valve repair device is pushed out of the distal end of the delivery sheath 40, the valve repair device switches from the extended state (delivery state) to the captured state. After reaching the captured state, the position is adjusted and the valve repair device is then switched from the captured state to the closed state, thereby both anchoring the valve repair device and clamping the two leaflets, converting a large single hole into a small double hole, thereby achieving the purpose of valve repair treatment.

[0063] Figure 2 This is an exemplary embodiment of the valve repair device of the present invention in the captured state. Figure 2 As shown, in this embodiment, the number of the clamping parts 2 is multiple, and the multiple clamping parts 2 are distributed circumferentially around the axis A of the valve repair device. Preferably, the multiple clamping parts 2 are evenly distributed along the circumference. It should be noted that the present invention does not exclude the situation where there is only one clamping part 2. Usually, the number of the clamping parts 2 is two, which are used to clamp two leaflets at the same time. The clamping part 2 can switch between different states under the force applied by the support part 4, usually, between an extended state and a captured state, and between a captured state and a closed state. The captured state can be understood as any state between the extended state and the closed state.

[0064] In an exemplary embodiment, referring to Figure 1 and Figure 2 , and combined with Figure 11The clamping part 2 includes a first clamping arm 221, a third clamping arm 223 and a second clamping arm 222 connected in sequence. These clamping arms are preferably connected as a whole or in an integral manner, such as being woven or cut into a whole. Here, the clamping length of the valve repair device in different states is increased or decreased by changing the position of the third clamping arm 223. Preferably, the stiffness of the third clamping arm 223 is smaller than the stiffness of the first clamping arm 221 and the stiffness of the second clamping arm 222, that is, the third clamping arm 223 is softer than the first clamping arm 221 and the second clamping arm 222. This arrangement allows the third clamping arm 223 to change position as the state of the valve repair device changes, ultimately achieving the effect of a small capture space in the capture state and a long closed clamping length in the closed state.

[0065] The proximal end of the first clamping arm 221 is connected to the proximal end of the clamping member 2, and the distal end of the second clamping arm 222 is connected to the distal end of the clamping member 2. The anchoring member 5 is located on a side of the first clamping arm 221 away from the second clamping arm 222 and is fixedly connected to the first clamping arm 221. The proximal end of the support member 4 is movably connected to the first clamping arm 221 or the second clamping arm 222, and the distal end of the support member 4 is fixedly connected to the distal end of the clamping member 2. The proximal end of the support member 4 is movably connected to the first clamping arm 221 or the second clamping arm 222, allowing the proximal end of the support member 4 to generate a certain displacement relative to the first clamping arm 221 or the second clamping arm 222, thereby allowing the support member 4 to pull the clamping member 2, causing the third clamping arm 223 to change position and increase the clamping length when closed.

[0066] like Figure 1 As shown, when the valve repair device is in a closed state, the pillar component 4 stretches out in the direction of the axis A and has a higher height, the clamping component 2 gathers inward in a direction perpendicular to the axis A, and the third clamping arm 223 and the first clamping arm 221 are roughly arranged in the same line in the direction of the axis A of the valve repair device, and are closer to the axis A of the valve repair device than the second clamping arm 222. The collinear arrangement here is a collinear arrangement in a broad sense, that is, at least a part of the third clamping arm 223 is collinear with the first clamping arm 221 in the direction of the axis A. It can be further understood that the inward projection of the third clamping arm 223 and the first clamping arm 221 in the direction perpendicular to the axis A is within the range of the positive projection of the pillar component 4, so that the axial height H1 of the clamping component 2 in the closed state is higher than the axial height H2 of the pillar component 4. In the closed state, the relative position relationship of the three clamping arms can be seen in Figure 12 .like Figure 12 As shown, in the closed state, the third clamping arm 223 is at the highest position and serves as an extended portion of the first clamping arm 221 , which also makes the axial height H1 of the clamping component 2 greater than the axial height H2 of the support component 4 .

[0067] like Figure 2 As shown, when the valve repair device is in the capture state, the pillar part 4 retracts and has a smaller height and is inclined relative to the axis A, the clamping part 2 expands outward in a direction perpendicular to the axis A, and the third clamping arm 223 and the second clamping arm 222 are roughly collinearly arranged in the direction of the axis A of the valve repair device and roughly away from the axis A of the valve repair device, while the first clamping arm 221 is arranged almost perpendicular to the axis A of the valve repair device. Similarly, the collinear arrangement here should also be a collinear arrangement in a broad sense, that is, basically collinear in the direction of the axis A. It can be further understood that the inward projection of the third clamping arm 223 and the second clamping arm 222 in the direction perpendicular to the axis A is within the range of the positive projection of the pillar part 4. At this time, the third clamping arm 223 is used as the outer clamping surface of the clamping part 2. In the capture state, the relative position relationship of the three clamping arms can be seen in Figure 14 .like Figure 14 As shown, in the captured state, the first clamping arm 221 is at the highest position, and the third clamping arm 223 serves as an extended portion of the second clamping arm 222 .

[0068] also, Figure 13 The movement of the third clamping arm 223 during the transition from the closed state to the captured state is also shown. Figure 13 As shown, during the process of switching from the closed state to the captured state, the third clamping arm 223 moves from the position of the first clamping arm 221 to the position of the second clamping arm 222, until the third clamping arm 223 moves to a position substantially collinear with the second clamping arm 222. Conversely, during the process of switching from the captured state to the closed state, the third clamping arm 223 moves from the position of the second clamping arm 222 to the position of the first clamping arm 221, until the third clamping arm 223 moves to a position substantially collinear with the first clamping arm 221. In the captured state, the approximate position of the third clamping arm 223 can be referred to Figure 2 and Figure 14 .like Figure 2 As shown, a third clamping arm 223 is formed between the schematic point a and the schematic point b on the clamping component 2 .

[0069] It should be understood that all the clamping arms described herein are elastic and can change their own shapes under the action of external forces, that is, change the states of the first clamping arm 221, the third clamping arm 223 and the second clamping arm 222. For example, the first clamping arm 221 and the third clamping arm 223 can be relatively folded ( Figure 2 ) or collinear state ( Figure 1 ), the first clamping arm 221 and the second clamping arm 222 can be relatively folded ( Figure 1 ) or collinear state ( Figure 2), and the first clamping arm 221 and the second clamping arm 222 are basically in a folded state relative to each other. In this embodiment, the clamping component 2 is usually made of a strip or a plate.

[0070] There is no special requirement for the relative size of the rigidity of the first clamping arm 221 and the rigidity of the second clamping arm 222. Further, the rigidity of the second clamping arm 222 is less than the rigidity of the first clamping arm 221. It should be understood that there can be many ways to make the rigidity of the third clamping arm 223 smaller than that of the other clamping arms, and one of them can be selected to execute. Generally, the clamping arms can be cut or woven into shape. When weaving, the third clamping arm 223 can adopt a weaving method different from the first clamping arm 221 and the second clamping arm 222 to achieve the purpose of reducing rigidity, such as the weaving density of the third clamping arm 223 is sparser, or the number of braided wires of the third clamping arm 223 is less than the number of braided wires of the other clamping arms, or the braided wire diameter of the third clamping arm 223 is smaller, or different weaving processes (one press one or one press two) are adopted, but are not limited to this. For example, when cutting and forming, the third clamping arm 223 can be cut differently from the first clamping arm 221 and the second clamping arm 222 to reduce the rigidity. The third clamping arm 223 not only connects the first clamping arm 221 and the second clamping arm 222, but also increases the inner clamping length when closed.

[0071] Typically, the working state of the valve repair device is controlled by an external delivery device. The control here includes but is not limited to controlling the conversion of the valve repair device between different forms, for example, it also includes implanting the valve repair device into the patient's body and delivering it to the target position (ventricle), and it may also include controlling the opening and closing of the anchoring component 5, and after repair, the delivery device is detached from the valve repair device and withdrawn from the patient's body, etc.

[0072] Specifically, such as Figure 8 As shown, an embodiment of the present invention further provides a delivery device, which includes a control wire 20 and a pushing component 30. Furthermore, the pushing component 30 includes a pushing wire 31 and a pushing tube 32. The control wire 20 is detachably connected to the anchoring component 5 to control the opening and closing of the anchoring component 5. The pushing component 30 is detachably connected to the proximal end and the distal end of the clamping component 2, respectively, to control the switching of the state of the valve repair device, specifically by controlling the relative movement of the proximal end and the distal end of the clamping component 2 to switch the state of the valve repair device. In addition, the valve repair device can also be controlled to be delivered into the patient's body. Of course, after the valve repair is completed, the delivery device needs to be withdrawn from the human body.

[0073] Furthermore, embodiments of the present invention provide a valve repair system comprising a delivery device and a valve repair device. Specifically, when the proximal and distal ends of the clamping member 2 are manipulated by the pushing member 30 to move relative to each other along the axial direction of the valve repair device, the clamping member 2 can change its clamping length between a closed state and a captured state, such that the axial height H1 of the clamping member 2 in the closed state is greater than the axial height H2 of the strut member 4, thereby increasing the inner clamping length of the clamping member 2 in the closed state to be greater than the inner clamping length of the clamping member 2 in the captured state.

[0074] In this embodiment, during the process of the valve repair device being manipulated by the delivery device to switch from the capture state to the closed state, the proximal end of the pillar component 4 can move relative to the first clamping arm 221 or the second clamping arm 222, and pull the clamping component 2, so that the clamping component 2 gradually increases and retracts inward, and at the same time, the third clamping arm 223 moves from the position of the second clamping arm 222 to the position of the first clamping arm 221, and finally the third clamping arm 223 moves to a position collinear with the first clamping arm 221, and the clamping component 2 is higher than the pillar component 4, thereby making the inner clamping length of the clamping component 2 in the closed state greater than the inner clamping length of the clamping component 2 in the capture state. holding length; on the contrary, when the valve repair device is manipulated by the delivery device to switch from the closed state to the captured state, the proximal end of the pillar part 4 can also move relative to the first clamping arm 221 or the second clamping arm 222, and pull back the clamping part 2, so that the clamping part 2 gradually lowers its height and opens outward, and at the same time, the third clamping arm 223 moves from the position of the first clamping arm 221 to the position of the second clamping arm, and finally the third clamping arm 223 moves to a position collinear with the second clamping arm 222, and the clamping part 2 is not higher than the pillar part 4, so that the inner clamping length of the clamping part 2 in the captured state is the length of the first clamping arm 221.

[0075] In one example, when the valve repair device switches from the captured state to the closed state, the proximal end of the strut component 4 can be raised above the anchor component 5, such that the axial height H2 of the strut component 4 is higher than the axial height of the anchor component 5. Conversely, when the valve repair device switches from the closed state to the captured state, the proximal end of the strut component 4 can fall back to the side of the anchor component 5 near the first clamping arm 221 (i.e., below) and be retracted into the interior of the clamping component 2.

[0076] Reference Figure 8 The pushing component 30 further includes a pushing wire 31 and a pushing tube 32. Figure 1 and Figure 2As shown, the valve repair device further includes a connector component, which includes a proximal connector 1 and a distal connector 6. The proximal connector 1 is arranged at the proximal end of the clamping component 2, and the distal connector 6 is arranged at the distal end of the clamping component 2. Furthermore, the distal end of the push tube 32 is detachably connected to the proximal connector 1, and the distal end of the push wire 31 is detachably connected to the distal connector 6 after passing through the push tube 32 and the proximal connector 1 in sequence. This application has no particular restrictions on the method of detachable connection, including but not limited to threaded connection. In one embodiment, when the push tube 32 holds the proximal end of the clamping component 2 stationary, the push wire 31 is pushed and pulled by the delivery device to move back and forth along the axis A of the valve repair device, thereby achieving the conversion of the valve repair device into different forms. In another alternative embodiment, when the push wire 31 holds the distal end of the clamping component 2 stationary, the push tube 32 is pushed and pulled by the delivery device to move back and forth along the axis A of the valve repair device, thereby achieving the conversion of the valve repair device into different forms. The push tube 32 and push wire 31 both stabilize the valve repair device and adjust its configuration. Without limitation, the distal connector 6 is provided with internal threads that mate with the external threads at the distal end of the push wire 31. During the repair process, the distal end of the push wire 31 extends into the distal connector 6 and is screwed into place. To withdraw the push wire 31, the push wire 31 can be separated from the distal connector 6 by twisting it in the opposite direction.

[0077] The distal end of the clamping member 2 moves relative to the proximal end as a schematic illustration. Figure 2 The capture state transforms to Figure 1 To restore the closed state, the push wire 31 only needs to pull the distal connector 6 (i.e., the distal end of the clamping component 2 or the valve repair device), driving the distal connector 6 to move closer to the proximal connector 1. During this process, the multiple clamping components 2 gradually converge toward the axis A of the valve repair device. At the same time, the proximal end of the strut component 4 gradually moves toward the axis A, causing the proximal end of the strut component 4 to gradually increase in height away from the distal connector 6, until the third clamping arm 223 is higher than the strut component 4. This increases the length of the native valve 10 clamped to the sum of the length L2 of the third clamping arm 223 and the length L1 of the first clamping arm 221, that is, the equivalent clamping length (inner clamping length) is L1+L2. Obviously, the clamping length in the closed state is increased, the anchoring is more secure, the anchoring property is better, and the effect of treating reflux is better. It should be understood that, in the closed state, the axial height of the support member 4 can be equal to the axial height of the anchor member 5, or the axial height of the support member 4 can be slightly higher than the axial height of the anchor member 5. It should be understood that the length of the anchor member 5 is equal to the length of the first clamping arm 221.

[0078] In the extended state, the valve repair device is usually in an axially stretched state. In this embodiment, the valve repair device is deformed from the extended state to Figure 2 In the capture state, as long as the push wire 31 controls the distal connector 6 and drives the distal connector 6 toward the proximal connector 1, during this process, the multiple clamping components 2 gradually open in a direction away from the axis A of the valve repair device, and the proximal end of the support component 4 gradually moves in a direction away from the axis A, until the first clamping arm 221 is opened and is almost perpendicular to the axis A of the valve repair device, and the third clamping arm 223 and the second clamping arm 222 are in a straight line and folded relative to the first clamping arm 221. It can be understood that in the capture state, due to the greater rigidity of the support component 4, the support component 4 is limited in its stretching. At this time, the effective capture length (inner clamping length) of the valve repair device is the length L1 of the first clamping arm 221. Therefore, the lateral profile size becomes smaller, so that when the operating space is limited, the safety and operational effectiveness are better. It should also be understood that in the captured state, due to the certain rigidity of the second clamping arm 222, the third clamping arm 223 is pulled toward itself (i.e., downward). At this point, the effective outer capture length is the length L2 of the third clamping arm 223 combined with the length of the second clamping arm 222. Ultimately, the transverse profile of the valve repair device in the captured state is twice the length L1 of the first clamping arm 22 plus the thickness of the spacer 7 described below. As can be understood, because the third clamping arm 223 is pulled toward the second clamping arm 222, the length of the first clamping arm 221 is minimized, thereby satisfying the requirement for minimal space occupied in the heart when capturing the native valve 10.

[0079] Therefore, in the closed state, the inner clamping length of the clamping member 2 (for one side) is the sum of the length L2 of the third clamping arm 223 and the length L1 of the first clamping arm 221. Correspondingly, the outer length of the clamping member 2 is only the length of the second clamping arm 222. In this case, the length of the clamping member 2 when clamping the native valve 10 is increased. Conversely, in the captured state, the inner clamping length of the clamping member 2 is the length L1 of the first clamping arm 221, so that the clamping length no longer includes the length L2 of the third clamping arm 223. Correspondingly, the outer length of the clamping member 2 is the sum of the length L2 of the second clamping arm 222 and the length L2 of the third clamping arm 223. Therefore, the outer clamping length also includes the length L2 of the third clamping arm 223. In this case, the transverse profile of the valve repair device is reduced.

[0080] In addition, the anchoring member 5 is further fixedly connected to the first clamping arms 221 of all the clamping members 2 to prevent relative movement between the anchoring member 5 and the first clamping arms 221, thereby ensuring the effectiveness of the anchoring. There are many ways to achieve the connection between the first clamping arms 221 and the anchoring member 5, including but not limited to suture connection, welding, bonding or bolt connection. Figure 5 When in use, the anchoring component 5 is mainly positioned on the inner side of the native valve 10 (i.e., the side close to the center of the valve), and the first clamping arm 221 is positioned on the outer side of the native valve 10 (the side away from the center of the valve), and the first clamping arm 221 directly contacts the native valve 10. All the clamping components 2 cooperate with the anchoring component 5 to clamp the native valve 10. The main function of the anchoring component 5 is to capture the native valve 10 in advance, that is, in the capturing state, the native valve 10 is first positioned on the anchoring side of the anchoring component 5 (the side facing the native valve 10), and preferably, structures such as barbs are used to grab the native valve 10 for anchoring first, and then the entire valve repair device is closed to complete the clamping. As an example, one or more rows of barbs are provided on the anchoring component 5, and the barbs penetrate into the leaflets, which can improve the capture of the leaflets by the anchoring component 5 and the stability and reliability of the clamping.

[0081] Furthermore, the proximal end of the strut component 4 needs to be movably connected to the first clamping arm 221 or the second clamping arm 222 in the clamping component 2, and the distal end of the strut component 4 and the distal end of the second clamping arm 222 are both fixed to the distal end of the valve repair device (i.e., the distal end of the clamping component 2). Furthermore, the distal ends of all second clamping arms 222 and the distal ends of the strut component 4 are fixedly connected to the distal connector 6. The present application does not limit the connection method between the second clamping arm 222 and the distal connector 6, and the connection method between the distal end of the strut component 4 and the distal connector 6. In practice, they can be implemented in a variety of ways, such as at least one of suturing, welding, bonding, clamping, and bolting.

[0082] Furthermore, the distal connector 6 includes a first connector 61 and a second connector 62 that are coaxially connected. The second connector 62 is disposed on the proximal side of the first connector 61, and the distal end of the pillar component 4 passes through and is fixed in the first connector 61 and the second connector 62. Optionally, the second connector 62 is connected to the push wire 31, and the second connector 62 is often threadedly connected to the push wire 31, but is not actually limited to a threaded connection. Furthermore, the second connector 62 and the first connector 61 cooperate and clamp the distal end of the pillar component 4, making such a structure easier to assemble. In other embodiments, the second connector 62 and the first connector 61 may be an integral or one-piece structure.

[0083] In one embodiment, the third clamping arm 223 and the first clamping arm 221 are arranged with the movable connection position as the boundary, and the movable connection position does not interfere with the anchoring movement of the anchoring member 5. For better effect, the connection position between the proximal end of the support member 4 and the first clamping arm 221 or the second clamping arm 222 should be as close as possible to the third clamping arm 223. In the embodiment of the present application, the position of the third clamping arm 223 can be changed because the third clamping arm 223 has a certain flexibility and a movable connection (including but not limited to a flexible connection) between the pillar part 4 and the first clamping arm 221 or the second clamping arm 222. The movable connection enables the proximal end of the pillar part 4 to move relative to the first clamping arm 221 or the second clamping arm 222 during the process of switching the valve repair device from the capture state to the closed state. The pillar part 4 has a large stiffness and the third clamping arm 223 has a relatively small stiffness, so that the third clamping arm 223 can be moved to a position higher than the pillar part 4, and finally the effective length of the current clamping of the native valve 10 becomes the length L1 of the first clamping arm 221 and the length L2 of the third clamping arm 223, thereby achieving tightening while increasing the closed length. On the contrary, when the valve repair device switches from the extended state to the captured state, because the stiffness of the support component 4 is relatively large and the stiffness of the third clamping arm 223 is relatively small, the second clamping arm 222 can pull the third clamping arm 223 to the circumferential outside without increasing the lateral profile size.

[0084] Furthermore, the valve repair device further includes a connecting component (not shown), through which the proximal end of the strut component 4 (elastically crushed) is flexibly connected to the first clamping arm 221 or the second clamping arm 222, and the distal end of the strut component 4 is fixedly connected to the distal end of the clamping component 2. The connecting component not only connects the strut component 4 and the clamping component 2, but also allows the proximal end of the strut component 4 to generate a certain displacement relative to the first clamping arm 221 or the second clamping arm 222, thereby enabling the strut component 4 to pull the first clamping arm 221 or the second clamping arm 222 to increase the clamping length during closure.

[0085] The connecting component can flexibly connect the support component 4 and the first clamping arm 221 or the second clamping arm 222 in a variety of ways. For example, the connecting component can use flexible structures such as sutures, flexible flanges, flexible clamps or springs to achieve flexible connection. Of course, other known flexible connection technologies can also be used, and this application does not limit this. The connecting component should have a certain tensile strength to connect the support component 4 and the clamping component 2, and also has the function of transmitting force when the state is changed. The material for preparing the connecting component can be a medical grade polymer material, including but not limited to polyethylene (such as ultra-high molecular weight polyethylene), or a metal elastic material or a metal superelastic material, preferably a shape memory alloy material.

[0086] like Figure 2As shown, in this embodiment, the valve repair device further includes a spacer 7, and a plurality of clamping components 2 are arranged along the circumference of the spacer 7, preferably evenly arranged along the circumference. Furthermore, the proximal end of the spacer 7 is connected to the proximal connector 1. The proximal ends of the first clamping arms 221 of all the clamping components 2 are connected to the distal end of the spacer 7. At this time, the anchoring component 5 is located between the spacer 7 and the first clamping arm 221. Figure 5 As shown, the spacer 7 can be positioned between the leaflets of the mitral valve or the tricuspid valve, and then in the captured state, the transverse profile size should also include the thickness of the spacer 7. The spacer 7 can have a planar form or a spatial form, which can reduce the risk of tearing of the leaflets after the leaflets are clamped and repaired. In this embodiment, the spacer 7 has a planar form, such as being woven from a braided wire plane. The spacer 7 is preferably integrally or integrally connected to the clamping part 2, such as being cut or woven into an integral part. In more detail, for any one of the clamping parts 2, the proximal end of the first clamping arm 221 is connected to the distal end of the spacer 7, the distal end of the first clamping arm 221 is connected to the proximal end of the third clamping arm 223, the distal end of the third clamping arm 223 is connected to the proximal end of the second clamping arm 222, and the distal end of the second clamping arm 222 is fixedly connected to the distal connector 6.

[0087] Furthermore, the anchoring member 5 is arranged around the periphery of the spacer 7. The present application does not impose any specific restrictions on the structure of the anchoring member 5, which can be implemented using an existing structure that can be understood by those skilled in the art. As an exemplary embodiment, Figure 6 As shown, the anchoring component 5 includes a plurality of anchoring portions 51, and the plurality of anchoring portions 51 are distributed circumferentially around the axis A of the valve repair device, preferably uniformly distributed circumferentially. The number of anchoring portions 51 is the same as the number of clamping components 2. Each anchoring portion 51 is connected to the first clamping arm 221 in each clamping component 2 in a one-to-one correspondence. The anchoring portion 51 is always located between the spacer 7 and the first clamping arm 221. The anchoring portion 51 is kept from moving relative to the first clamping arm 221 as much as possible to ensure the effectiveness of anchoring and treatment. The anchoring portion 51 can be optionally a metal plate, which is preferably a double-layer plate structure to enhance rigidity, so that the leaflet is captured more firmly and the captured leaflet is not easy to fall off, and is combined with one or more rows of barbs to further increase the anchoring performance.

[0088] like Figure 6 As shown, the anchoring portion 51 may include an anchoring plate 511 and a support plate 512; the support plate 512 is fixedly arranged on the first clamping arm 221, and the support plate 512 is close to the first clamping arm 221, preferably the support plate 512 is parallel to the first clamping arm 221; one end of the anchoring plate 511 (the end corresponding to the inner edge, that is, the end closer to the axis A) is elastically connected to the support plate 512, so that the anchoring plate 511 is exerted with elastic force toward the support plate 512. The position of the anchoring portion 51 changes accordingly with the change in the shape of the clamping part 2. When the clamping part 2 is in the captured state (see Figure 2), since there is an elastic connection between the support plate 512 and the anchor plate 511, the anchor plate 511 is applied with an elastic force toward the support plate 512, and the support plate 512 is fixed on the first clamping arm 221, then the anchor plate 511 can be opened compared to the support plate 512 under the action of an external force. Specifically, an external force in a generally upward direction is applied to the anchor plate 511, so that the anchor plate 511 and the support plate 512 are opened, roughly in a “>” shape, thereby capturing the leaflets (making the leaflets enter between the anchor plate 511 and the support plate 512). After the external force is removed, the anchor plate 511 recovers under the action of the elastic force and clamps the leaflets between the anchor plate 511 and the support plate 512. It can be understood that the degree of opening and closing of the anchor plate 511 and the support plate 512 can be controlled by controlling the magnitude of the external force. The external force here is usually applied by the control wire 20 of the conveying system. Furthermore, the control wire 20 is connected to the anchoring plate 511, and the anchoring portion 51 is manipulated to capture and clamp the leaflets. When the clamping of the leaflets by the anchoring portion 51 is not ideal, the anchoring portion 51 is manipulated to recapture and clamp the leaflets. Each anchoring portion 51 is manipulated by at least one control wire 20. In this embodiment, two control wires 20 are respectively connected to the anchoring plates 511 of the two anchoring portions 51. During the operation, when the clamping component 2 is in the capturing state, the control wire 20 is manipulated to control the anchoring plate 511 to open so as to capture and clamp the leaflets. Specifically, the clamping state of the leaflets by the anchoring portion 51 is observed by external ultrasonic imaging equipment. If the clamping state does not achieve the ideal effect, the leaflets can be recaptured and clamped under the action of the control wire 20. All control wires 10 do not interfere with each other, and the corresponding anchoring parts 51 can be manipulated simultaneously, and the corresponding anchoring parts 51 can be manipulated individually to achieve the function of separately opening and capturing the two anchoring plates 511, thereby meeting the surgical requirements of the single anchoring part 51 operation needs that may arise during the operation.

[0089] In this way, after the clamping component 2 in the extended state is implanted into the patient's ventricle along with the valve repair device, the clamping component 2 is then converted to a closed state and placed between the leaflets of the mitral valve or tricuspid valve along with the spacer 7 below. After the clamping component 2 is converted to a capture state, the leaflets are captured and clamped by the anchoring portion 51 on the first clamping arm 221. When all the anchoring portions 51 have clamped their corresponding leaflets, the clamping component 2 is finally converted to a closed state to achieve edge-to-edge repair of the mitral valve or tricuspid valve.

[0090] The clamping part 2 is an elastic structure, and the clamping part 2 is preferably an elastic structure with shape memory properties. The clamping part 2 is mostly made of wire material woven flat, and can also be cut flat from a plate, but the weaving or plate structure is not restrictive. As an example, the clamping part 2 is woven from a plurality of wires, preferably a shape memory alloy wire such as nickel titanium wire, and in other examples, the clamping part 2 is cut from an elastic plate, preferably a shape memory alloy such as nickel titanium plate. In this embodiment, the plurality of clamping parts 2 provide support force to the anchoring part 5 during the capture process, and apply clamping stress to the leaflet during the closing process to clamp the leaflet. In order to avoid tearing of the leaflet due to excessive clamping stress, the clamping part 2 is preferably a woven structure with a certain degree of elasticity.

[0091] The support component 4 is also an elastic structure, preferably made of shape memory alloy material. The stiffness of the support component 4 is generally greater than that of the clamping component 2. The clamping component 2 is similar to the support component 4, and these structures can be expanded and closed, and switched between these states. The main function of the support component 4 is to maintain the shape of the valve repair device when it is closed, captured, and extended, and it plays the role of supporting the clamping component 2. In this embodiment, the support component 4 is always located on the inner side of the second clamping arm 222, but as the state changes, the proximal end of the support component 4 can move to the outside of the clamping component 2, so that the axial height H1 of the clamping component 2 is higher than the axial height H2 of the support component 4. As an example, the support component 4 is composed of a plurality of support members 41, and the plurality of support members 41 are arranged circumferentially around the axis A of the valve repair device, preferably evenly arranged circumferentially.

[0092] Further, such as Figure 7As shown, every two support members 41 form an elastic pressure ring 42, and each clamping component 2 is correspondingly provided with an elastic pressure ring 42 or more elastic pressure rings 42, which can achieve a better supporting effect. The number of support members 41 can be set according to actual needs. In this embodiment, the number of support members 41 is four, and the four support members 41 are evenly arranged circumferentially around the axis A of the valve repair device. The elastic pressure ring 42 is not meant to be restrictive, and the pillar component 4 can also adopt other shapes and configurations. The elastic pressure ring 42 is a non-closed annular structure, and the distal end 42a of the elastic pressure ring 42 has two ends close to each other, and a gap is formed between the two ends, which can be fixedly connected to the distal connector 6. In this embodiment, the proximal end 42b of the elastic pressure ring 42 is flexibly connected to the first clamping arm 221 or the second clamping arm 222 to directly connect the elastic pressure ring 42 to the first clamping arm 221 or the second clamping arm 222. As can be understood, the clamping member 2 changes shape under the combined action of the elastic pressure ring 42 and the delivery device, and the anchoring portion 51 disposed on the first clamping arm 221 changes its position as the clamping member 2 changes shape. Furthermore, the clamping member 2 in the closed state is driven by the elastic pressure ring 42 to converge toward the spacer 7, thereby improving the repaired shape of the mitral or tricuspid valve, enhancing the repair effect, and reducing the risk of recurrence of mitral or tricuspid regurgitation. It should be noted that to reduce the trauma to human tissue caused by valve clamping, the outer surface of the valve repair device is typically coated with at least one layer of polymer film.

[0093] The operation process of the valve repair device is further described below with reference to some exemplary embodiments.

[0094] Before delivering the valve repair device, first adjust the membrane repair device to an extended state so that it can be compressed and loaded into the delivery sheath 40. The extended state can be achieved by pushing the push wire 31 so that the distal connector 6 is away from the spacer 7, and the elastic pressure ring 42 and the clamping part 2 are extended along the axis A and approach the outer periphery of the push wire 31. Further, after the device is compressed, the axial direction of the valve repair device is extended and the lateral width is shortened to facilitate delivery into the sheath. After the valve repair device is delivered to the target position, the valve repair device is released and the valve repair device is inserted into the sheath. Figure 2 The capture status of . Figure 2 and Figure 8First, partially retract the push wire 31, and the elastic pressure ring 42 will stretch the clamping part 2 so that the clamping part 2, the elastic pressure ring 42, and the push wire 31 are in a stable triangular shape. That is, the first clamping arm 221 of the clamping part 2 is almost perpendicular to the axis A of the valve repair device, the push wire 31 is parallel to (including overlapping with) the axis A, and the elastic pressure ring 42 is in an inclined state. Then, pull the control wire 20 to lift the anchor plate 511 of the anchoring part 51, and the anchoring part 51 is in an open state; then gradually place the first clamping arm 221 below the leaflet (i.e., outside the leaflet), adjust and determine the clamping position, and then replay the control wire 20 to cause the anchor plate 511 of the anchoring part 51 to fall back, and the anchoring part 51 is in a closed state, thereby capturing the leaflet. Optionally, each anchoring part 51 can be opened and closed one by one to adjust according to the capture situation; or all anchoring parts 51 can be opened and closed simultaneously.

[0095] After the leaflets are captured, the valve repair device enters the final closed state to clamp the leaflets. Figure 1 and Figure 8 As shown, continue to retract the push wire 31 to bring the distal connector 6 closer to the proximal connector 1. At the same time, it will drive the elastic pressure ring 42 to gather toward the axis A of the valve repair device. Correspondingly, the first clamping arm 221, the third clamping arm 223 and the anchoring portion 51 also gather toward the axis A of the valve repair device. Based on this, the leaflets gather toward the axis A of the valve repair device under the clamping of the anchoring portion 51, thereby achieving closed clamping of the leaflets. Finally, withdraw the push wire 31, the control wire 20, the push tube 32 and the delivery sheath 40, and the valve repair is completed.

[0096] Next, reference will be made to comparative examples to further highlight the effects that can be achieved by the valve repair device of the present application.

[0097] Reference Figure 9 and Figure 10 The valve repair device of the comparative embodiment does not have the third clamping arm 223, and one of the first clamping arm 221 and the second clamping arm 222 is fixedly connected to the support member 4 instead of being movable. Figure 9 As shown, when closed, the effective clamping length of the valve repair device is only L1 (i.e., the length of the first clamping arm 221), which is positively correlated with this. Figure 10 As shown, the effective capture length of the valve repair device of the comparative embodiment in the capture state is also L1. Even though the outline size in the capture state is small, the clamping length is short, which cannot meet the requirements of small capture space and long clamping length in actual needs.

[0098] Furthermore, based on the above embodiments, the present invention also provides an operating method for a valve repair device, which is used to control the valve repair device to switch between different states through a delivery device. The operating method specifically includes the following process:

[0099] Connect the control wire 20 to the anchoring component 5, and use the control wire 20 to control the opening and closing of the anchoring component 5;

[0100] The pushing component 30 is connected to the proximal end and the distal end of the clamping component 2 respectively, and the opening and closing of the clamping component 2 is controlled by the pushing component 30;

[0101] During use, when the pushing component 30 manipulates the proximal and distal ends of the clamping component 2 to move relative to each other along the axial direction of the valve repair device, the proximal end of the support component 4 produces a certain displacement relative to the clamping component 2, so that the clamping component 2 can change the clamping length between the closed state and the captured state, and the axial height of the clamping component 2 in the closed state is higher than the axial height of the support component 4, thereby making the inner clamping length of the clamping component 2 in the closed state greater than the inner clamping length of the clamping component 2 in the captured state.

[0102] Furthermore, the method for switching the valve repair device from the captured state to the closed state includes the following steps: the pushing component 30 manipulates the proximal and distal ends of the clamping component 2 to move relatively close together, driving the proximal end of the strut component 4 to move relative to the first clamping arm 221 or the second clamping arm 222, and pulling the first clamping arm 221 or the second clamping arm 222 to drive the third clamping arm 223 to move from the position of the second clamping arm 222 to the position of the first clamping arm 221 until the third clamping arm 223 moves to a position collinear with the first clamping arm 221, thereby ensuring that the inner clamping length of the clamping component 2 in the closed state is the sum of the length of the third clamping arm 223 and the length of the first clamping arm 221. During this process, the proximal end of the strut component 4 can move to the side of the anchoring component 5 facing away from the clamping component 2 and be higher than the anchoring component 5.

[0103] Furthermore, the method for switching the valve repair device from the closed state to the captured state includes the following steps: the pushing component 30 manipulates the proximal and distal ends of the clamping component 2 to move relatively close together, driving the proximal end of the strut component 4 to move relative to the first clamping arm 221 or the second clamping arm 222, and pulling the first clamping arm 221 or the second clamping arm 222 to drive the third clamping arm 223 to move from the position of the first clamping arm 221 to the position of the second clamping arm 222, until the third clamping arm 223 moves to a position collinear with the second clamping arm 221, thereby ensuring that the inner clamping length of the clamping component 2 in the captured state is the length of the first clamping arm 221. At this time, the proximal end of the strut component 4 falls back to the side of the anchoring component 5 close to the first clamping arm 221 and retracts inwardly no further than the anchoring component 5.

[0104] In summary, when the valve repair device and system provided by the present application are used to repair a heart valve, the space occupied by the valve repair device in the heart when capturing the valve can be reduced, the operational safety and operational effectiveness can be improved, and the length of the valve effectively clamped when the valve is closed and clamped can be increased, making the anchoring more secure and the treatment of regurgitation more effective. Furthermore, the present application, through the combination of rigid and flexible clamping arms in the clamping component, converts the relatively softer clamping arms into an effective clamping length, thereby increasing the closed length, making the effective length of the valve repair device when capturing the valve longer, and at the same time, the profile when capturing the valve becomes smaller, making the space occupied by the device in the heart smaller. In general, the structure of the valve repair device is simple and easy to implement, and its safety and effectiveness are effectively improved, solving the problem that existing valve repair devices cannot meet the requirements of small capture space and long closed clamping length.

[0105] It should be noted that the various embodiments in this specification are described in a progressive manner, with each embodiment focusing on the differences from other embodiments. Reference can be made to the common and similar parts between the various embodiments. The systems disclosed in the embodiments are described briefly because they correspond to the methods disclosed in the embodiments. For relevant details, refer to the method description.

[0106] It should also be noted that although the present invention has been disclosed above with reference to preferred embodiments, the above embodiments are not intended to limit the present invention. Any person skilled in the art can utilize the above disclosed technical content to make many possible changes and modifications to the technical solution of the present invention without departing from the scope of the technical solution of the present invention, or modify it into an equivalent embodiment with equivalent changes. Therefore, any simple modifications, equivalent changes, and modifications made to the above embodiments based on the technical essence of the present invention without departing from the content of the technical solution of the present invention shall still fall within the scope of protection of the technical solution of the present invention.

[0107] It should also be understood that, unless otherwise specified or indicated, the terms "first", "second", "third", etc. in the specification are only used to distinguish the various components, elements, steps, etc. in the specification, and are not used to indicate the logical relationship or sequential relationship between the various components, elements, steps, etc.

[0108] It should also be understood that the terms described herein are intended to describe particular embodiments only and are not intended to limit the scope of the invention. It should be noted that the singular forms "a" and "an" as used herein and in the appended claims include plural references unless the context clearly indicates otherwise. For example, a reference to "a step" or "a device" means a reference to one or more steps or devices, and may include secondary steps as well as secondary devices. All conjunctions used should be understood in their broadest sense. Also, the word "or" should be understood to have the definition of a logical "or" rather than a logical "exclusive or" unless the context clearly indicates otherwise. Furthermore, implementation of the methods and / or apparatus in embodiments of the present invention may include performing selected tasks manually, automatically, or in combination.

Claims

1. A valve repair device, characterized in that: The device comprises a clamping component, an anchoring component, and a support component; the anchoring component is arranged outside the clamping component and connected to the clamping component; the anchoring component is used to cooperate with the clamping component to clamp the native valve; the support component is at least partially arranged inside the clamping component and connected to the clamping component; the support component can elastically support the clamping component to maintain the shape of the valve repair device; The valve repair device has a closed state and a captured state, and can be switched between the closed state and the captured state. In the closed state, the axial height of the clamping part is higher than the axial height of the support part, and the inner clamping length of the clamping part in the closed state is greater than the inner clamping length of the clamping part in the captured state.

2. The valve repair device according to claim 1, characterized in that: The clamping component includes a first clamping arm, a third clamping arm, and a second clamping arm connected in sequence, wherein the proximal end of the first clamping arm is connected to the proximal end of the clamping component, and the distal end of the second clamping arm is connected to the distal end of the clamping component; the anchoring component is located on a side of the first clamping arm away from the second clamping arm, and is fixedly connected to the first clamping arm; the proximal end of the support component is movably connected to the first clamping arm or the second clamping arm, and the distal end of the support component is fixedly connected to the distal end of the clamping component; The third clamping arm can change its position between a closed state and a captured state so that the inner clamping length of the clamping part in the closed state is the sum of the length of the third clamping arm and the length of the first clamping arm, and the inner clamping length of the clamping part in the captured state is the length of the first clamping arm.

3. The valve repair device according to claim 2, characterized in that: The stiffness of the third clamping arm is smaller than the stiffness of the first clamping arm and the stiffness of the second clamping arm.

4. The valve repair device according to claim 2 or 3, characterized in that: It also includes a connecting component, through which the proximal end of the support component is flexibly connected to the first clamping arm or the second clamping arm, and the connecting component is at least one of a suture, a flexible flange, a flexible clamp and a spring.

5. The valve repair device according to claim 2 or 3, characterized in that: It also includes a spacer, a plurality of the clamping parts, and the plurality of the clamping parts are arranged along the circumference of the spacer. The distal end of the spacer is connected to the first clamping arms of all the clamping parts, and the anchoring part is located between the spacer and the first clamping arm.

6. The valve repair device according to claim 5, characterized in that: It also includes a joint component, which includes a proximal connecting piece and a distal connecting piece, the proximal connecting piece is connected to the proximal end of the spacer, and the distal end of the second clamping arm and the distal end of the support component are both connected to the distal connecting piece; the joint component is used to be detachably connected to the conveying device, and can move along the axial direction of the valve repair device under the operation of the conveying device, thereby controlling the valve repair device to switch between different states.

7. The valve repair device according to claim 6, characterized in that: The distal end connecting member includes a first connecting member and a second connecting member that are coaxially connected. The second connecting member is arranged on the proximal side of the first connecting member. The distal end of the support component passes through and is fixed in the first connecting member and the second connecting member.

8. The valve repair device according to claim 2 or 3, characterized in that: The pillar component is composed of multiple support members, and the multiple support members are arranged along the circumference of the valve repair device, and / or the anchoring component includes an anchoring part, and the anchoring part includes an anchoring plate and a support plate, and the support plate is fixedly arranged on a side of the first clamping arm close to the anchoring part, and one end of the anchoring plate is elastically connected to the support plate.

9. A valve repair system, characterized in that: The invention comprises a delivery device and the valve repair device according to any one of claims 1 to 8, wherein the delivery device comprises a control wire and a pushing component; the control wire is detachably connected to the anchoring component to control the opening and closing of the anchoring component; the pushing component is detachably connected to the proximal end and the distal end of the clamping component to control the switching of the state of the valve repair device; When the proximal and distal ends of the clamping part are manipulated by the pushing part to move axially relative to each other, the clamping part can change the clamping length between the closed state and the captured state, and make the axial height of the clamping part in the closed state higher than the axial height of the support part, thereby making the inner clamping length of the clamping part in the closed state greater than the inner clamping length of the clamping part in the captured state.

10. The valve repair system according to claim 9, characterized in that: The clamping component includes a first clamping arm, a third clamping arm, and a second clamping arm connected in sequence, wherein the proximal end of the first clamping arm is connected to the proximal end of the clamping component, and the distal end of the second clamping arm is connected to the distal end of the clamping component; the anchoring component is located on a side of the first clamping arm away from the second clamping arm and is fixedly connected to the first clamping arm; the proximal end of the support component is movably connected to the first clamping arm or the second clamping arm, and the distal end of the support component is fixedly connected to the distal end of the clamping component; When the valve repair device is manipulated by the delivery device to switch from the captured state to the closed state, the third clamping arm moves from the position of the second clamping arm to the position of the first clamping arm until it moves to a position collinear with the first clamping arm, thereby making the inner clamping length of the clamping component in the closed state the sum of the length of the third clamping arm and the length of the first clamping arm; During the process of the valve repair device being manipulated by the conveying device to switch from a closed state to a captured state, the third clamping arm moves from the position of the first clamping arm to the position of the second clamping arm until it moves to a position collinear with the second clamping arm, thereby making the inner clamping length of the clamping part in the captured state the length of the first clamping arm.

11. The valve repair system according to claim 9 or 10, characterized in that: The pushing component includes a pushing tube and a pushing wire, and the valve repair device also includes a joint component, which includes a proximal connecting piece and a distal connecting piece. The proximal connecting piece is arranged at the proximal end of the clamping component, and the distal connecting piece is arranged at the distal end of the clamping component. The distal end of the pushing tube is detachably connected to the proximal connecting piece, and the distal end of the pushing wire is detachably connected to the distal connecting piece after passing through the pushing tube and the proximal connecting piece in sequence.

12. A method for operating a valve repair device, characterized in that: The method for controlling the valve repair device according to any one of claims 1 to 8 to switch between different states through a delivery device comprises: Connecting a control wire of the delivery device to the anchoring component, and controlling the opening and closing of the anchoring component by the control wire; Connecting the pushing components of the conveying device to the proximal end and the distal end of the clamping component respectively, and controlling the opening and closing of the clamping component by the pushing components; In which, during the process of the pushing component manipulating the proximal and distal ends of the clamping component to move axially relative to each other, the proximal end of the pillar component produces a certain displacement relative to the clamping component, so that the clamping component can change the clamping length between the closed state and the captured state, and the axial height of the clamping component in the closed state is higher than the axial height of the pillar component, thereby making the inner clamping length of the clamping component in the closed state greater than the inner clamping length of the clamping component in the captured state.

13. The method for operating the valve repair device according to claim 12, characterized in that: The clamping component includes a first clamping arm, a third clamping arm, and a second clamping arm connected in sequence, wherein the proximal end of the first clamping arm is connected to the proximal end of the clamping component, and the distal end of the second clamping arm is connected to the distal end of the clamping component; the anchoring component is located on a side of the first clamping arm away from the second clamping arm and is fixedly connected to the first clamping arm; the proximal end of the support component is movably connected to the first clamping arm or the second clamping arm, and the distal end of the support component is fixedly connected to the distal end of the clamping component, wherein: The method for switching the valve repair device from the capture state to the closed state comprises the following steps: The pushing component manipulates the proximal end and the distal end of the clamping component to move relatively close to each other, drives the proximal end of the support component to move relative to the first clamping arm or the second clamping arm, and drives the third clamping arm to move from the position of the second clamping arm to the position of the first clamping arm, until the third clamping arm moves to a position collinear with the first clamping arm, thereby making the inner clamping length of the clamping component in the closed state the sum of the length of the third clamping arm and the length of the first clamping arm; The method for switching the valve repair device from the closed state to the captured state comprises the following steps: The pushing component manipulates the proximal and distal ends of the clamping component to be relatively close, drives the proximal end of the pillar component to move relative to the first clamping arm or the second clamping arm, and drives the third clamping arm to move from the position of the first clamping arm to the position of the second clamping arm until the third clamping arm moves to a position collinear with the second clamping arm, thereby making the inner clamping length of the clamping component in the captured state the length of the first clamping arm.

Images