Valve clamping device with sufficient fitting and valve clamping system

Abstract

The present invention discloses a valve clamping device and a valve clamping system with sufficient fitting. The valve clamping device with sufficient fitting includes a support part, an adjustment part and a clamping part. The support part has a certain axial length and includes a first end and a second end arranged oppositely; the adjustment part includes a first end and a second end arranged oppositely, and a self-expanding body located between the first end and the second end; the first end of the adjustment part is movably sleeved on the outside of the support part, the second end of the adjustment part is sleeved on the outside of the support part and fixedly connected to the support part, and the first end of the adjustment part is located between the first end of the support part and the second end of the adjustment part; the clamping part is arranged on the outside of the support part and can be expanded or closed relative to the adjustment part. The valve clamping device with sufficient fitting can increase the fitting area between the valve leaflets and the adjustment part, enable the valve leaflets to be fully fitted with the adjustment part, and further improve the clamping force to firmly clamp the valve leaflets.

Description

Technical Field

[0001] This application relates to the technical field of interventional medical devices, and particularly to a valve clamping device and a valve clamping system with sufficient fitting. Background Art

[0002] Please refer to Figure 1 , the mitral valve 1 is a one-way valve located between the left atrium 2 and the left ventricle 3 of the heart. A normal and healthy mitral valve 1 can control the blood flow from the left atrium 2 to the left ventricle 3, while preventing the blood from flowing from the left ventricle 3 to the left atrium 2. The mitral valve 1 includes a pair of valve leaflets, called the anterior leaflet 1a and the posterior leaflet 1b. The anterior leaflet 1a and the posterior leaflet 1b are fixed to the papillary muscles of the left ventricle 3 by chordae tendineae 4. Under normal circumstances, when the left ventricle 3 of the heart contracts, the edges of the anterior leaflet 1a and the posterior leaflet 1b are completely opposed to prevent the blood from flowing from the left ventricle 3 to the left atrium 2. Please refer to Figure 2 , when the valve leaflets of the mitral valve 1 or its related structures undergo organic or functional changes, such as partial rupture of the chordae tendineae 4, the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1 do not fit well. As a result, when the left ventricle 3 of the heart contracts, the mitral valve 1 cannot be completely closed, leading to blood reflux from the left ventricle 3 to the left atrium 2, thereby causing a series of pathophysiological changes, known as "mitral regurgitation".

[0003] Interventional mitral valve clamping refers to implanting a valve clamping device into the mitral valve and using a pair of closable clamping arms to pull the anterior and posterior leaflets towards each other, reducing or eliminating the leaflet gap to treat mitral regurgitation. Figure 3 and Figure 4An existing valve clamping device is shown. The valve clamping device 90 adds an elastic net 93 to two clamping arms 91. The leaflets L on each side are respectively clamped between one clamping arm 91 and one side of the elastic net 93. The distance between the leaflets is adapted by the deformation of the elastic net 93, so as to adjust the pulling degree of the clamping arm 91 on the leaflet L. One end 931 of the elastic net 93 is fixedly connected to the first end 951 of the support part 95 (the first end 951 refers to the end of the support part 95 close to the rotation connection part of the two clamping arms 91) through a head such as a steel sleeve. The other end 933 of the elastic net 93 is a free end that movably surrounds the support part 95. When the two clamping arms 91 are closed, the elastic net 93 is squeezed and deformed. Since the head 97 restricts the axial movement of one end 931 of the elastic net 93, the elastic net 93 will elongate axially towards its free end 933. At the same time, the two sides of the elastic net 93 squeezed by the two clamping arms 91 will retract radially. The free end 933 of the elastic net 93 and the parts near it are affected by the retracted parts and gradually converge towards the central axis of the elastic net 93. This causes a radial gap X between the free end 933 of the elastic net 93 and the parts near it and the leaflet L, that is, the leaflet L cannot fit the free end 933 of the elastic net 93 and the parts near it. The elastic fitting area between the leaflet L and the elastic net 93 is limited. Correspondingly, the free end 933 of the elastic net 93 and the parts near it cannot provide a radial supporting force for the leaflet L, which may cause the clamping force of the clamping arm 91 and the elastic net 93 on the leaflet L to be insufficient to firmly clamp the leaflet L, and there is a risk that the leaflet L falls off between the clamping arm 91 and the elastic net 93, affecting the implantation stability of the valve clamping device; at the same time, the radial gap X between the free end 933 of the elastic net 93 and the parts near it and the leaflet L allows the blood flowing back from the self-clamping gap to pass through, affecting the treatment effect of the backflow. Summary of the Invention

[0004] To solve the above technical problems or at least partially solve the above technical problems, the present application provides a valve clamping device and a valve clamping system with sufficient fitting.

[0005] In a first aspect, the present application provides a valve clamping device with sufficient fitting, including:

[0006] A support part, the support part has a certain axial length and includes a first end and a second end arranged oppositely;

[0007] An adjusting part, the adjusting part includes a first end and a second end arranged oppositely, and a self-expanding body located between the first end and the second end; the first end of the adjusting part is movably sleeved outside the support part, the second end of the adjusting part is sleeved outside the support part and fixedly connected to the support part, and the first end of the adjusting part is located between the first end of the support part and the second end of the adjusting part;

[0008] A clamping part, which is arranged outside the supporting part and can be unfolded or closed relative to the adjusting part.

[0009] In a second aspect, the present application provides a valve clamping system, including the above-mentioned valve clamping device with sufficient fitting and a delivery device. Among them, the delivery device includes: a pushing sheath with a certain axial length and a mandrel movably inserted in the pushing sheath. The pushing sheath is detachably connected to the supporting part, and the mandrel is used to drive the unfolding and closing of the clamping part.

[0010] For the valve clamping device and the valve clamping system provided by the present application, the second end of the adjusting part is sleeved outside the supporting part and fixedly connected to the supporting part, the first end of the adjusting part is movably sleeved outside the supporting part, and the first end of the adjusting part is arranged between the first end of the supporting part and the second end of the adjusting part. When the clamping part is closed relative to the adjusting part to clamp the valve leaf between the self-expanding body of the adjusting part and the clamping part, the axial movement of the second end of the adjusting part and the part of the self-expanding body near it is restricted. The self-expanding body will elongate axially towards the first end of the adjusting part. At the same time, the self-expanding body will retract radially under the extrusion of the clamping part. Along with the first end of the adjusting part extending towards the valve margin of the valve leaf, the self-expanding body gradually converges towards the central axis of the adjusting part towards the first end of the adjusting part. The part of the self-expanding body near the second end of the adjusting part can be in close fit with the valve leaf without a radial gap. Compared with the prior art, it can increase the fitting area between the valve leaf and the adjusting part, so that the valve leaf and the adjusting part are fully fitted. Correspondingly, the second end of the adjusting part and the part of the self-expanding body near it can provide a radial supporting force for the valve leaf, thereby improving the clamping force to firmly clamp the valve leaf, reducing the risk of the valve leaf falling off between the clamping part and the adjusting part, and enhancing the implantation stability of the valve clamping device. At the same time, the close fit between the part of the self-expanding body near the second end of the adjusting part and the valve leaf can block the blood flowing back from the clamping gap, optimizing the treatment effect of the regurgitation. Description of the Drawings

[0011] The drawings here are incorporated into the description and form a part of this description. The drawings show some embodiments of the present invention and are used together with the description to explain the principles of the present invention.

[0012] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required for use in the description of the embodiments or the prior art. Obviously, for those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on these drawings.

[0013] Figure 1 It is a schematic diagram of the normal state of the mitral valve;

[0014] Figure 2 It is a schematic diagram when the mitral valve is diseased;

[0015] Figure 3 It is a schematic structural diagram of an existing valve clamping device;

[0016] Figure 4 It is Figure 3 A schematic diagram of the state when the valve clamping device shown clamps the valve leaflets;

[0017] Figure 5 It is a schematic structural diagram of the valve clamping device according to the first embodiment of the present invention;

[0018] Figure 6 It is Figure 5 A schematic structural diagram after the combination of the adjusting part and the supporting part in

[0019] Figure 7 It is Figure 5 A schematic structural diagram after the combination of the adjusting part and the fixing part in

[0020] Figure 8a It is Figure 5 A three-dimensional structural diagram of the adjusting part in from a perspective;

[0021] Figure 8b It is Figure 5 A three-dimensional structural diagram of the adjusting part in from another perspective;

[0022] Figure 9 It is Figure 5 A schematic diagram of the state when the valve clamping device in clamps the valve leaflets;

[0023] Figure 10 It is Figure 5 A schematic structural diagram after the combination of the clamping part and the driving part in

[0024] Figure 11 It is Figure 5 A schematic structural diagram of the supporting part in

[0025] Figure 12 It is Figure 5 A schematic structural diagram of the cooperation between the supporting part and the base in

[0026] Figure 13 It is Figure 5 A schematic structural diagram of the cooperation between the supporting part of the valve clamping device in and the delivery device;

[0027] Figures 14 - 18 It is the use of Figure 5 A schematic diagram of the process of the valve clamping device in approaching the mitral valve anterogradely through the left atrium and performing edge-to-edge repair;

[0028] Figure 19 It is a schematic structural diagram of the valve clamping device according to the second embodiment of the present application;

[0029] Figure 20 is Figure 19 a schematic structural diagram after the combination of the adjusting part and the supporting part in

[0030] Figure 21 is Figure 19 a schematic structural diagram after the combination of the adjusting part and the fixing part in

[0031] Figure 22 It is a schematic diagram of the state when the valve clamping device according to the third embodiment of the present application clamps the valve leaflet;

[0032] Figure 23 It is a schematic structural diagram of the valve clamping device according to the fourth embodiment of the present application;

[0033] Figure 24 is Figure 23 a schematic structural diagram after the combination of the supporting part, the driving part and the clamping part in

[0034] Figure 25 is Figure 23 a schematic diagram of the state when the valve clamping device in clamps the valve leaflet;

[0035] Figure 26 It is a schematic structural diagram of the valve clamping device according to the fifth embodiment of the present application;

[0036] Figure 27 It is a schematic structural diagram of the valve clamping device according to the sixth embodiment of the present application;

[0037] Figure 28 is Figure 27 a schematic structural diagram after the combination of the supporting part, the driving part and the clamping part in

[0038] Figure 29 It is a schematic structural diagram of the valve clamping device according to the seventh embodiment of the present application;

[0039] Figure 30 It is a schematic structural diagram of the cooperation between the valve clamping device according to the eighth embodiment of the present application and the delivery device;

[0040] Figure 31 is Figure 30 a schematic diagram of the valve clamping device shown in approaching the mitral valve through the apical approach. Detailed implementation manners

[0041] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all of the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0042] In the description of the present invention, it should be noted that:

[0043] The orientation or positional relationship indicated by terms such as "upper", "lower", "inner", "outer", etc. is based on the orientation or positional relationship shown in the accompanying drawings. It is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be construed as a limitation to the present invention. In addition, terms such as "first", "second", etc. are only used for descriptive purposes and cannot be construed as indicating or implying relative importance;

[0044] When an element is referred to as "fixed to" or "disposed on" another element, the element can be directly connected to the other element, or indirectly connected to the other element through one or more connecting elements. When an element is referred to as "connected to" another element, it can be directly connected to the other element, or connected to the other element through one or more connecting elements.

[0045] It should also be noted that in the field of interventional medical devices, the proximal end refers to the end closer to the operator, while the distal end refers to the end farther from the operator; the direction of the rotation center axis of an object such as a cylinder or a tube is defined as the axial direction; the circumferential direction is the direction around the axis of an object such as a cylinder or a tube (perpendicular to the axis and perpendicular to the cross-sectional radius at the same time); the radial direction refers to the direction along the diameter or radius. It should be noted that regardless of the "end" in words such as "proximal end", "distal end", "one end", "the other end", "the first end", "the second end", "the initial end", "the terminal end", "both ends", "the free end", "the upper end", "the lower end", etc., it not only refers to the end head, endpoint or end face, but also includes the part that extends a certain axial distance and / or radial distance on the element to which the end head, endpoint or end face belongs from the end head, endpoint or end face. The above definitions are only for the convenience of expression and should not be construed as a limitation to the present invention.

[0046] Embodiment 1

[0047] Please refer to Figures 5 - 9 , a valve clamping device 100 with sufficient fitting provided by the first embodiment of the present invention includes:

[0048] A support part 110, the support part 110 has a certain axial length and includes a first end 111 and a second end 115 arranged oppositely;

[0049] The adjusting part 120, the adjusting part 120 includes a first end 121 and a second end 123 which are oppositely arranged, and a self-expanding body 125 located between the first end 121 and the second end 123;

[0050] And a clamping part 130, the clamping part 130 is arranged outside the adjusting part 120 and can be expanded or closed relative to the adjusting part 120.

[0051] The first end 121 of the adjusting part 120 of the valve clamping device 100 is movably sleeved outside the supporting part 110, and the second end 123 of the adjusting part 120 is sleeved outside the supporting part 110 and fixedly connected to the supporting part 110. The first end 121 of the adjusting part 120 is located between the first end 111 of the supporting part 110 and the second end 123 of the adjusting part 120. Or rather, the first end 121 of the adjusting part 120 is closer to the first end 111 of the supporting part 110 than the second end 123 of the adjusting part 120.

[0052] Combined with Figure 5 and Figures 14 - 18 , a connecting part (not marked) detachably connected (such as screw connection, snap connection, etc.) to the delivery device 200 is provided on the second end 115 of the supporting part 110 of the valve clamping device 100 of the first embodiment. If the delivery device 200 pushes the valve clamping device 100 into the heart through a catheter, then the second end 115 of the supporting part 110 is its proximal end, the first end 111 of the supporting part 110 is its distal end, the second end 123 of the adjusting part 120 is its proximal end, and the first end 121 of the adjusting part 120 is its distal end. It can be understood that in other embodiments, the valve clamping device can enter the heart through the apex, then the second end of the supporting part is its distal end, the first end of the supporting part is its proximal end, the second end of the adjusting part is its distal end, and the first end of the adjusting part is its proximal end.

[0053] Please also refer to Figures 5 - 9, the valve clamping device 100 mainly includes two states, one is the deployed state and the other is the closed state. In the deployed state, the adjusting part 120 is in a natural state without external force. The diameter of the self-expanding body 125 of the adjusting part 120 gradually increases from the first end 121 of the adjusting part 120 to the second end 123 of the adjusting part 120. That is, the overall shape of the adjusting part 120 is approximately an inverted cone shape. The first end 121 of the adjusting part 120 generally constitutes the vertex of the inverted cone shape, and the part near the second end 123 of the adjusting part 120 constitutes the bottom of the inverted cone shape. In this first embodiment, one end of the clamping part 130 is rotatably connected to the first end 111 of the supporting part 110, so that the clamping part 130 can expand or close around the adjusting part 120 with the rotation connection part between it and the first end 111 of the supporting part 110 as the center. There is an axial distance between the first end 121 of the adjusting part 120 and the first end 111 of the supporting part 110. Thus, when the adjusting part 120 is radially squeezed, the first end 121 of the adjusting part 120 can move axially towards the first end 111 of the supporting part 110. Then, during the process that the clamping part 130 closes around the adjusting part 120 with the rotation connection part between it and the first end 111 of the supporting part 110 as the center to clamp the leaflet 1, the adjusting part 120 is squeezed by the clamping part 130 and shows the phenomenon of radial retraction and axial elongation. It can be understood that in other embodiments, one end of the clamping part 130 can also be rotatably connected to other components, as long as this component is close to the first end 111 of the supporting part 110, so that the clamping part 130 is arranged outside the supporting part 110 and can expand or close relative to the adjusting part 120 to clamp the leaflet.

[0054] It should be noted that in the closed state, since the second end 123 of the adjusting part 120 is fixedly connected to the supporting part 110, the first end 121 of the adjusting part 120 is movably sleeved on the supporting part 110, the axial movement of the second end 123 of the adjusting part 120 and the part near it on the self-expanding body 125 is restricted, the self-expanding body 125 will elongate axially towards the first end 121 of the adjusting part 120, and at the same time, the self-expanding body 125 will retract radially under the extrusion of the clamping part 130. Along with the extension of the first end 121 of the adjusting part 120 towards the leaflet edge of the leaflet 1, the overall shape of the adjusting part 120 can be complementary to the shape at the opening of the clamping part 130 and still presents an inverted conical shape. The part of the self-expanding body 125 near the second end 123 of the adjusting part 120 is located at the conical bottom of the inverted conical shape, that is, the self-expanding body 125 gradually converges towards the central axis of the adjusting part 120 towards the first end 121 of the adjusting part 120. The part of the self-expanding body 125 near the second end 123 of the adjusting part 120 can be closely attached to the leaflet 1 without radial clearance, which can increase the fitting area between the leaflet 1 and the adjusting part 120 compared with the prior art, improve the elastic fitting property between the leaflet 1 and the adjusting part 120, and make the leaflet 1 and the adjusting part 120 fully fit. Correspondingly, the second end 123 of the adjusting part 120 and the part of the self-expanding body 125 near it can provide a large radial supporting force for the leaflet 1, thereby increasing the clamping force to firmly clamp the leaflet 1, reducing the risk of the leaflet 1 falling off between the clamping part 130 and the adjusting part 120, and improving the implantation stability of the valve clamping device 100; at the same time, the close fit between the part of the self-expanding body 125 near the second end 123 of the adjusting part 120 and the leaflet 1 can block the blood flowing back from the self-clamping gap and optimize the treatment effect of the backflow. In addition, the adjusting part 120 can adaptively adjust its own shape according to the different clamping degrees of the clamping part 130, and can ensure that it can fully fit the leaflet at any clamping degree.

[0055] It can be understood that in the closed state, the first end 121 of the adjusting part 120 can extend towards the leaflet edge compared with the prior art and is closer to the leaflet edge position, further increasing the fitting area between the leaflet 1 and the adjusting part 120 and further improving the elastic fitting property between the leaflet 1 and the adjusting part 120.

[0056] In addition, since the first end 121 of the adjusting part 120 is movably sleeved on the supporting part 110, the adjusting part 120 has strong axial deformation ability. When the valve clamping device 100 is radially compressed into the delivery sheath for in-vivo delivery, it is relatively easy to be compressed into the sheath.

[0057] Specifically, please refer to Figure 5 and Figures 10 - 13, the support portion 110 can be a circular tube body, a square column tube body, an oval tube body, etc. with both end faces axially penetrating. In this embodiment, a circular tube body is adopted. As described above, the distal end of the circular tube body is the first end 111, and the proximal end is the second end 115. The second end 115 of the support portion 110 can be surrounded and shielded by a part near the second end 123 of the adjustment portion 120 in both the closed state and the deployed state, so that the adjustment portion 120 is not exposed, preventing the second end 115 from directly contacting the valve leaflet, avoiding the second end 115 from wearing the valve leaflet along with the long-term pulsation of the valve leaflet, and improving the implantation safety.

[0058] The support portion 110 is further provided with a through channel 113 in the shape of an axial through hole to cooperate with the driving portion 140 and the delivery device 200 in a linkage manner. At least two clamping positions 114 are provided on the tube wall of the circular tube body of the support portion 110 for detachably connecting with the delivery device 200. For example, a clamping platform 221 is provided on the delivery device 200. After the clamping platform 221 is clamped into the clamping position 114, the delivery device 200 is clamped and connected with the support portion 110, and the delivery of the valve clamping device 100 can be carried out. When the clamping platform 221 is separated from the clamping position 114, the delivery device 200 is separated from the valve clamping device 100. It should be understood that the structure of the support portion 110 here is only for example and is not a limitation to this application. Other structures of the support portion 110 adopted by those of ordinary skill in the art based on the teachings of this application are all within the protection scope of this application.

[0059] Please refer to Figures 5 - 9 , the self-expanding body 125 of the adjustment portion 120 is a mesh structure, preferably a mesh structure woven by wire materials with shape memory function or cut from a tube, such as superelastic materials such as nickel-iron alloy wires. At the same closing degree of the clamping portion 130, the adjustment portion 120 can adapt to the distance between different valve leaflets and deform adaptively, so as to adjust the pulling degree of the valve clamping device 100 on the valve leaflet. The adjustment portion 120 has a hollow accommodation cavity (not marked), and the portion of the support portion 110 between the second end 115 and the first end 111 is arranged in the hollow accommodation cavity.

[0060] The self-expanding body 125 includes a first section 124, a second section 126 and a third section 128 connected in sequence. The first section 124 extends from the second end 123 of the adjustment portion 120 towards the second end 115 of the support portion 110, and a concave area 122 similar to a bowl shape is formed between the first section 124 and the second section 126 (such as Figure 7 and Figure 8aAs shown, the first section 124 surrounds the outside of the second end 115 of the support portion 110, or rather, the second end 115 of the support portion 110 is located within the recessed area 122. The second end 115 of the support portion 110 can be surrounded and shielded by the first section 124 of the self-expanding body 125 in both the closed state and the deployed state of the valve clamping device 100, so that the adjusting portion 120 will not be exposed. The second section 126 continues to extend radially outward from the first section 124. The third section 128 extends radially inward from the second section 126 towards the first end 111 of the support portion 110 and stops at the first end 121 of the adjusting portion 12. In this first embodiment, the end of the recessed area 122 (defining the end of the recessed area 122 as the end of the first section 124 close to the second end 123 of the adjusting portion 120) extends towards the first end 111 of the support portion 110 to the second end 123 of the adjusting portion 120.

[0061] When manufacturing the adjusting portion 120, first prepare a braided net tube with both ends open. Sleeve one end of the braided net tube on a lining rod, and then sleeve a forming sleeve outside one end of the braided net tube to form the second end 123 of the adjusting member 120. Then, pull the other end of the braided net tube outward and downward simultaneously, so that the braided net tube turns outwards onto the forming die. Then, perform heat setting treatment to form the adjusting portion 120 whose overall shape is approximately an inverted cone shape as shown in Figures 8a - 8b figure, and the other end of the braided net tube forms the first end 121 with an opening of the adjusting member 120 below one end of the braided net tube. Remove the forming sleeve and the forming die to obtain the adjusting portion 120.

[0062] When assembling the adjusting portion 120 and the support portion 110, the part between the second end 115 and the first end 111 of the support portion 110 is inserted into the hollow accommodating cavity of the adjusting portion 120. The second end 123 of the adjusting portion 120 is fixedly connected to the support portion 110 through a fixing member 80. The fixing member 80 can be a steel sleeve. The second end 123 of the adjusting portion 120 is inserted between the steel sleeve and the outer surface of the support portion 110, and then the steel sleeve and the support portion 110 are laser welded to realize the fixed connection between the second end 123 of the adjusting portion 120 and the support portion 110. It can be understood that in other embodiments, the fixing member 80 may not be provided, and the second end 123 of the adjusting portion 120 may be directly fixedly connected to the support portion 110 by welding. In this embodiment, the second end 123 of the adjusting portion 120 is inserted into the fixing member 80 towards the first end 111 of the support portion 110. If Figure 6The orientation where the second end 123 of the adjusting part 120 is located is the upper, and the orientation where the first end 121 of the adjusting part 120 is located is the lower. That is, the second end 123 of the adjusting part 120 is inserted into the fixing part 80 from top to bottom. The diameter of the opening of the first end 121 of the adjusting part 120 can be equal to or slightly larger than the diameter of the supporting part 110, so as to be sleeved on the supporting part 110 movably, so that the first end 121 of the adjusting part 120 can slide smoothly along the axis of the supporting part 110. In addition, since the second end 123 of the adjusting part 120 is fixedly connected to the supporting part 110, and the first end 121 of the adjusting part 120 is movably sleeved on the supporting part 110, the center of gravity of the entire valve clamping device 100 is always located on the axis of the supporting part 110. Therefore, the self-centering property is good and it is not easy to tilt.

[0063] More specifically, during the change process of the valve clamping device 100 from the deployed state to the closed state, the range of the radial dimension ( Figure 6 marked as D in the figure) of the second section 126 of the expansion main body 125 is preferably 4 mm - 15 mm, more preferably 5 mm - 10 mm, and the range of the radial dimension of the first end 121 of the adjusting part 120 is 1 mm - 5 mm, more preferably 1.2 mm - 3 mm, so that the inverted cone shape presented by the whole adjusting part 120 can adapt to the distance between different valve leaflets and have the largest possible contact area with the valve leaflets after being compressed.

[0064] Combined Figure 5 、 Figure 6 with Figure 9, in the closed state of the valve clamping device 100, that is, when the valve leaflet 1 is clamped between the adjusting part 120 and the clamping part 130, since the second end 123 of the adjusting part 120 is fixedly connected to the supporting part 110, the first end 121 of the adjusting part 120 is movably sleeved on the supporting part 110, the axial movement of the second end 123 of the adjusting part 120, the first section 124 and the second section 126 of the self-expanding body 125 is restricted, the adjusting part 120 will elongate axially towards its first end 121. At the same time, the self-expanding body 125 will retract radially under the extrusion of the clamping part 130, but the first section 124 will resist the inward deformation of the second section 126, and the second section 126 will transmit this resistance to the corresponding part of the third section 128 connected to it. Along with the extension of the first end 121 of the adjusting part 120 towards the valve edge of the valve leaflet 1, the overall shape of the adjusting part 120 presents an inverted conical shape complementary to the shape of the opening of the clamping part 130. The second section 126 is located at the bottom of the inverted conical shape, and the third section 128 of the self-expanding body 125 gradually converges towards the central axis of the adjusting part 120 from the second section 126 to the first end 121. The entire section of the third section 128 of the self-expanding body 125 can be in close contact with the valve leaflet 1 without radial clearance, and the elastic fit between the valve leaflet 1 and the adjusting part 120 is improved, so that the valve leaflet 1 and the adjusting part 120 can be fully fitted. Accordingly, the adjusting part 120 can provide a large radial supporting force for the valve leaflet 1, thereby increasing the clamping force to firmly clamp the valve leaflet 1. As Figure 9 shown, the second section 126 of the self-expanding body 125 is not lower than the end face of the free end when the clamping part 130 is closed, so that the length of the valve leaflet 1 clamped between the clamping part 130 and the adjusting part 120 is basically equal to the length of the clamping part 130.

[0065] It can be understood that in other embodiments, a biocompatible thin film can be covered outside and / or inside the mesh-structured adjusting part 120. On the one hand, this thin film can be used as a flow-blocking film to block the blood flowing back from the self-clamping gap, improve the treatment effect of blood reflux, and prevent blood from entering the adjusting part 120 to form thrombus. On the other hand, this thin film can make the valve clamping device 100 have stronger biocompatibility. The material of this thin film can be but is not limited to biocompatible polymers such as PTFE, EPTFE, polyester, silicone resin, etc.

[0066] Of course, the adjusting part 120 is not limited to a mesh structure, and can also be other elastic and self-expanding hollow structures. For example, it can be a dense silicone body or a porous sponge body. The second end of the adjusting part with a dense structure or a porous structure is fixedly sleeved on the supporting part 110, and the first end is axially movably sleeved on the supporting part 110. Similarly, similar first section, second section and third section can be provided between the second end and the first end, and the valve leaflet and the adjusting part can also be fully fitted based on the same principle.

[0067] Please refer to Figure 5 , and Figures 9 - 13 , the clamping part 130 includes at least two clamping arms 131, generally including at least one set of clamping arms 131, and each set of clamping arms 131 includes two clamping arms 131 symmetrically arranged relative to the adjusting part 120. In this embodiment, the clamping part 130 includes one set of clamping arms 131. It should be noted that this is only for example here. Those of ordinary skill in the art can select the appropriate number of clamping arms 131 according to needs, such as two sets or more sets of clamping arms. It can be understood that three or more clamping arms 131 can also be provided in each group according to needs. For example, three relatively openable and closable clamping arms 131 can be used to simultaneously clamp the three leaflets of the tricuspid valve to treat tricuspid regurgitation; or two leaflets of the tricuspid valve can be clamped by a pair of clamping arms 131 to also achieve the purpose of reducing or treating tricuspid regurgitation.

[0068] In this embodiment, the valve clamping device 100 further includes a driving part 140. The driving part 140 is connected to the clamping part 130 to drive the clamping part 130 to expand or close relative to the adjusting part 120. Specifically, the driving part 140 is respectively connected to each clamping arm 131. For example, the driving part 140 is respectively connected to the two clamping arms 131 in one set of clamping arms 131 to drive each clamping arm 131 to rotate around the adjusting part 120, so that the clamping arms 131 approach or move away from the adjusting part 120. In the delivery state, the driving part 140 drives the clamping arms 131 to close around the adjusting part 120, thereby reducing the outer diameter of the valve clamping device 100 and facilitating delivery; after the valve clamping device 100 is deployed in the heart, the driving part 140 drives the clamping arms 131 to clamp the leaflets between the clamping arms 131 and the adjusting part 120 to achieve leaflet clamping.

[0069] In a preferred embodiment of this embodiment, the valve clamping device 100 further includes a grasping part, generally including at least one set of grasping arms 151, and each set of grasping arms 151 includes two grasping arms 151 symmetrically arranged relative to the adjusting part 120. The grasping part (such as the grasping arms 151) is arranged between the clamping part 130 (such as the clamping arms 131) and the adjusting part 120 and can expand or close relative to the adjusting part 120, and at least part of the grasping part is accommodated in the inner surface of the clamping part 130. Of course, three or more grasping arms 151 can also be provided in each group according to needs, so as to cooperate with the clamping arms 131 to achieve the leaflet capturing function.

[0070] In the delivery state, the grasping part is at least partially received in the inner surface of the clamping part 130, that is, the grasping arm 151 is at least partially received in the inner surface of the clamping arm 131, thereby reducing the outer diameter of the valve clamping device 100 and facilitating delivery. After the clamping arm 131 and the grasping arm 151 cooperate to capture the valve leaflet, the grasping arm 151 presses the valve leaflet into the inner surface of the clamping arm 131, which can increase the contact area between the clamping arm 131 and the valve leaflet and increase the clamping force on the valve leaflet.

[0071] The valve clamping device 100 further includes a base 160 fixedly connected to the support part 110, and each clamping arm 131 is rotatably connected to the base 160. Specifically, the proximal end of the base 160 is fixedly connected to the first end 111 of the support part 110. It should be noted that for the convenience of description, this part is defined as the term "base" here. The structure that realizes the function of the base 160 can also be the first end 111 of the support part 110 itself. Therefore, the definition of the term "base" should not limit the scope of the present application. Each clamping arm 131 in each group is rotatably connected to each other on the base 160 through a pivot 132. The first end 121 of the adjusting part 120 is axially spaced from the base 160. Under the drive of the driving part 140, each clamping arm 131 can cooperate with each other to expand and close around the adjusting part 120.

[0072] In this embodiment, the driving part 140 includes: a driving shaft 141, a connecting seat 142, and two connecting rods 143. Wherein, one end of each connecting rod 143 is rotatably connected to the clamping part 130, and the other end is rotatably connected to the connecting seat 142; one end of the driving shaft 141 is fixedly connected to the connecting seat 142, and the other end is movably inserted into the base 160. Specifically, one end of each connecting rod 143 is rotatably connected to a clamping arm 131, and the other end is rotatably connected to the connecting seat 142 through a pivot 144, that is, each clamping arm 131 is rotatably connected to the connecting seat 142 of the driving shaft 141 through the connecting rod 143 on the corresponding side. The driving shaft 141 movably passes through the base 160. When the driving shaft 141 slides axially relative to the base 160, it drives the connecting rod 143 to rotate and drives the clamping arm 131 to expand or close around its rotation connection part with the base 160.

[0073] Specifically, the driving part 140 includes at least one group of connecting rods 143, and the arrangement of the connecting rods 143 corresponds to the arrangement of the clamping arms 131 one by one. For example Figure 10Two clamping arms 131 are adopted, and correspondingly, two link rods 143 that cooperate with each other are arranged. One end of the link rod 143 is rotatably connected to the connecting seat 142 through a pivot 144 such as a pin, etc., and the other end is rotatably connected to the corresponding clamping arm 131 through a pivot such as a pin, etc. Each clamping arm 131 is rotatably connected to the base 160 through a pivot 132 such as a pin, etc. When the drive shaft 141 moves axially relative to the base 160 towards the first end 111 of the support portion 110, it drives the link rod 143 to move. Under the pulling of the link rod 143, the clamping arm 131 rotates around the pivot 132 and opens relative to the base 160. When the drive shaft 141 moves axially relative to the base 160 towards the second end 115 of the support portion 110, the link rod 143 pushes the clamping arm 131 to rotate around the pivot 132 and close relative to the base 160. The shape of the connecting seat 142 can be any structure such as a hemisphere, a spherical crown or a bullet head shape, etc., so that the valve clamping device 100 can be more easily pushed in the body. The drive shaft 141 and the connecting seat 142 can be an integral structure or a non-integral structure. To ensure safety after implantation, the drive shaft 141 and the connecting seat 142 are made of biocompatible materials such as polyester, silicone, stainless steel, cobalt alloy, cobalt-chromium alloy or titanium alloy, and preferably stainless steel or cobalt-chromium alloy with higher hardness.

[0074] Preferably, as shown in Figure 10 The valve clamping device 100 further includes a locking portion 170 provided in the base 160, and the locking portion 170 restricts the relative movement between the drive shaft 141 and the base 160. In the delivery state, the locking portion 170 restricts the relative movement between the drive shaft 141 and the base 160, so as to ensure that the clamping portion 130 always remains in a closed state relative to the adjusting portion 120 and the support portion 110, and avoid accidental deployment of the clamping portion 130; after reaching near the mitral valve, the restriction of the locking portion 170 on the drive shaft 141 is unlocked, and the clamping portion 130 can be driven by the driving portion 140 to expand relative to the adjusting portion 120 and the support portion 110 and support the valve leaflets; after clamping the valve leaflets, the locking portion 170 restricts the relative movement between the drive shaft 141 and the base 160 again, so as to maintain the clamping state of the valve leaflets 1. Any existing locking portion with a suitable structure can be adopted, and details are not described herein.

[0075] Combined with Figure 5 and Figure 9 Furthermore, at the end of each clamping arm 131 (defining the end of the clamping arm 131 away from its rotatably connected part or the free end as the end of the clamping arm 131), there is also a flanging section 137. Starting from Figure 9From the front view perspective, the flanging section 137 is an arc surface that turns outward towards the end of the clamping arm 131, and the radius of this arc surface is preferably 1 mm - 2 mm. When the clamping arm 131 closes relative to the adjusting portion 120 to clamp the valve leaflet 1 therebetween, the valve leaflet 1 forms a fit with the flanging section 137 of the arc surface, increasing the supporting area of the end of the clamping arm 131 on the valve leaflet 1, which can avoid local stress concentration of the valve leaflet 1 at the end of the clamping arm 131, and effectively reduce the damage to the valve leaflet 1 caused by the repeated friction between the edge of the end of the clamping arm 131 and the valve leaflet 1 as the heart beats. After the clamping arm 131 abuts against the adjusting portion 120, the self-expanding body 125 of the adjusting portion 120 axially protrudes beyond the flanging section 137, or in other words, the second section 126 of the self-expanding body 125 is higher than the flanging section 137, so as to ensure that the length of the valve leaflet 1 clamped between the clamping arm 131 and the third section 128 of the self-expanding body 125 is not less than the length of the clamping arm 131.

[0076] Referring to Figures 13 - 17 , the present invention further provides a valve clamping system, including the above-mentioned valve clamping device 100 and a delivery device 200. Among them, the delivery device 200 includes: a push sheath 210 having a certain axial length and a mandrel (not shown in the figure) movably inserted into the push sheath 210. The push sheath 210 is detachably connected to the support portion 110, and the mandrel is detachably connected to the drive portion 140 for driving the expansion and closing of the clamping portion 130. In this embodiment, an external thread is provided at the proximal end of the drive shaft 141, and the mandrel is threadedly connected to the drive shaft 141, so that the axial movement of the drive shaft 141 can be controlled by the mandrel outside the patient's body. It should be understood that only some structures of the delivery device are listed here, and any other suitable existing structures can be adopted for the other parts, which will not be elaborated here.

[0077] Specifically, at least one clamping position 114 communicating with the lumen of the support portion 110 is symmetrically formed on the outer wall of the proximal end of the support portion 110. A connecting member 220 is provided at the distal end of the pushing sheath 210. The connecting member 220 includes two branches, and the end of each branch is a protruding clamping platform 221. In the natural state, both branches point towards the central axis of the connecting member 220. During assembly, the connecting member 220 is inserted into the support portion 110, and then the mandrel of the delivery device 200 is inserted into the pushing sheath 210 until the mandrel is inserted into the connecting member 220, pushing the two branches of the connecting member 220 outwards, and the clamping platforms 221 at the ends of the branches are snapped into the two clamping positions 114 of the support portion 110, thereby connecting the support portion 110 and the connecting member 220, that is, connecting the valve clamping device 100 and the delivery device 200. When the mandrel is withdrawn from the connecting member 220 and the pushing sheath 210, the two branches return to their natural inward state, and the clamping platforms 221 disengage from the clamping positions 114 of the support portion 110, so that the connection between the valve clamping device 100 and the delivery device 200 is released. The connecting member 220 can be made of a material with a certain hardness and elasticity such as nickel-titanium. The pushing sheath 210 can adopt a multi-layer composite tube body. The mandrel can be made of stainless steel or nickel-titanium alloy material.

[0078] Combined with Figure 11 with Figure 13 , a through hole is provided inside the support portion 110 as a threading channel 113 for the driving shaft 141. The driving shaft 141 is slidably inserted along the axial direction into the threading channel 113 of the support portion 110 and fixedly connected to the connecting seat 142. After the clamping portion 130 and the grasping portion 150 cooperate and capture the valve leaflets, the driving shaft 141 is driven to move axially by the mandrel to drive the clamping arms 131 to completely close relative to the support portion 110, so that the valve clamping device 100 is in a closed state and falls below the valve. Then, the connection between the mandrel and the driving shaft 141 can be released, the mandrel is withdrawn from between the connecting members 220, and the clamping platforms 221 are separated from the clamping positions 114 of the support portion 110, thereby realizing the disconnection of the valve clamping device 100 and the delivery device 200.

[0079] Refer to Figures 14 - 18 , taking the transcatheter approach through the interatrial septum - left atrium in the anterograde direction to approach and repair the mitral valve as an example, the use process of the valve clamping device 100 of the present application is described as follows:

[0080] The first step: As Figure 14 shown, the driving shaft 141 and the valve clamping device 100 connected thereto are advanced from the left atrium 2 through a guiding device such as an adjustable bending sheath (not shown in the figure), passing through the mitral valve 1 to reach the left ventricle 3;

[0081] The second step: Adjust the valve clamping device 100 to approach the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1;

[0082] The third step: AsFigure 15 As shown, unlock the locking part 170 in the unlocking base 160, push the mandrel and the drive shaft 141 towards the distal end, and the clamping arms 131 are driven to open relative to the support part 110. Adjust the direction of the clamping arms 131. At this time, the relative positions of the clamping arms 131 and the anterior leaflet 1a and posterior leaflet 1b of the mitral valve 1 can be observed through an X-ray device, so that the clamping arms 131 are perpendicular to the coaptation line of the mitral valve 1;

[0083] Step Four: As Figure 16 shown, retract the entire valve clamping device 100 towards the proximal end, so that the clamping arms 131 support the valve leaflets 1 on the left ventricle 3 side, release the grasping arms 151 on both sides, and each grasping arm 151 presses the valve leaflets 1 on the atrial side and cooperates with the clamping arms 131 on that side to capture the valve leaflets 1;

[0084] Step Five: As Figure 17 shown, when the anterior leaflet 1a and posterior leaflet 1b of the mitral valve 1 are respectively captured between a pair of clamping arms 131 and grasping arms 151, pull the mandrel and the drive shaft 141 towards the proximal end, thereby driving the clamping arms 131 to close;

[0085] Step Six: Release the threaded connection between the mandrel and the drive shaft 141, and retract the mandrel. The two branches of the connecting member 220 resume the state of approaching the central axis, the clamping platform 221 separates from the clamping position 114 of the support part 110, and the connection between the valve clamping device 100 and the delivery device 200 is released. Then, the delivery device 200 is withdrawn from the body, and the implanted state as shown in Figure 18 is obtained. At this time, the valve clamping device 100 pulls the anterior leaflet 1a and posterior leaflet 1b of the mitral valve 1 towards each other, obtaining a double-orifice mitral valve, and completing the edge-to-edge repair of the mitral valve.

[0086] After the valve clamping device 100 is implanted, the elastic adjustment part 120 is filled between the anterior leaflet 1a and posterior leaflet 1b of the clamped mitral valve 1, and provides a radial supporting force for the valve leaflets 1. The adjustment part 120 has a buffering effect on the pulsating valve leaflets 1, so as to realize that the pulling degree of the valve clamping device 100 on the valve leaflets 1 can be adjusted to avoid damaging the valve leaflets 1.

[0087] Embodiment Two

[0088] Please refer to Figures 19 - 21 . Compared with the valve clamping device 100 in the above-mentioned first embodiment, the structures of the support part 110, the clamping part 130, the drive part 140, the grasping part 151, etc. of the valve clamping device 100' provided by the second embodiment of the present invention remain unchanged and will not be elaborated here, but the structure of the adjustment part 120' has changed.

[0089] Specifically, in this second embodiment, the adjusting portion 120' adds a bending section 129 to the self-expanding body compared with the adjusting portion 120 in the first embodiment. The bending section 129 is connected between the second end 123 of the adjusting portion 120' and the first section 124 of the self-expanding body. Preferably, the cross-sectional shape of the bending section 129 is an arc-shaped concave towards the first end 121 of the adjusting portion 120'. The first section 124 and the bending section 129 still form a recessed area 122' relative to the second section 126. The end of the recessed area 122' (defining the end of the recessed area 122' as the end of the bending section 129 close to the second end 123 of the adjusting portion 120') extends towards the second end 115 of the support portion 110 to the second end 123 of the adjusting portion 120'.

[0090] When manufacturing the adjusting portion 120', first prepare a braided network tube with both ends open, sleeved on a lining rod, and then sleeve a forming sleeve on the outer upper end of the braided network tube to form the second end 123 of the adjusting member 120'; then push the lower end of the braided network tube upward (taking the orientation where the second end 123 of the adjusting portion 120' is located as the upper and the first end 121 as the lower in the middle), and perform heat setting treatment on the braided network tube with the aid of a forming die to form an adjusting portion 120' whose overall shape is still approximately frustum-shaped as shown in Figure 20 and Figure 20 and Figure 21 shown, and the lower end of the braided network tube forms the first end 121 with an opening of the adjusting member 120' below the upper end of the braided network tube. Remove the forming sleeve and the forming die to obtain the adjusting portion 120'.

[0091] When assembling the adjusting portion 120' and the support portion 110, the part between the second end 115 and the first end 111 of the support portion 110 is inserted into the hollow accommodating cavity of the adjusting portion 120. The second end 123 of the adjusting portion 120' is fixedly connected to the support portion 110 through a fixing member 80. The fixing member 80 can be a steel sleeve. The second end 123 of the adjusting portion 120 is inserted between the steel sleeve and the outer surface of the support portion 110, and then the steel sleeve and the support portion 110 are laser welded to realize the fixed connection between the second end 123 of the adjusting portion 120' and the support portion 110. In this embodiment, the second end 123 of the adjusting portion 120' is inserted into the fixing member 80 towards the second end 115 of the support portion 110, that is, the second end 123 of the adjusting portion 120' is inserted into the fixing member 80 from bottom to top.

[0092] In the closed state of the valve clamping device 100', the bent section 129 resists the inward deformation of the first section 124, and this resistance is superimposed and transmitted to the corresponding part of the third section 128 connected to the second section 126, further enhancing the elastic fit between the valve leaflet and the adjusting part 120, so that the valve leaflet and the adjusting part 120 can fit fully. Accordingly, the adjusting part 120 can provide a greater radial supporting force for the valve leaflet, and further improve the clamping force to firmly clamp the valve leaflet.

[0093] Embodiment III

[0094] As Figure 22 shown, compared with the valve clamping device of the first embodiment above, the structures of the supporting part, the clamping part, the driving part, the grasping part, etc. of the valve clamping device provided by the third embodiment of the present invention remain unchanged and will not be elaborated here, but the structure of the self-expanding body 125' of the adjusting part has changed.

[0095] In addition to including the first section 124, the second section 126 and the third section 128, the self-expanding body 125' in this Embodiment III further includes an adapting section 127. The adapting section 127 is connected between the second section 126 and the third section 128, and extends radially outward compared with the third section 128 (taking the central axis of the supporting part 110 as radially inward and the central axis deviating from the supporting part 110 as radially outward). The adapting section 127 is arranged corresponding to the flanging section 137 at the end of the clamping arm, and the shape of the side of the adapting section 127 facing the flanging section 137 is complementary to the arc surface presented by the flanging section 137.

[0096] When the clamping arm is closed relative to the adjusting part 120 to clamp the valve leaflet therebetween, the adapting section 127 protrudes axially from the flanging section 137, or in other words, the adapting section 127 is higher than the flanging section 137, and part of the valve leaflet is also clamped between the adapting section 127 and the flanging section 137. On the one hand, the valve leaflet forms a fit with the arc surface of the flanging section 137, increasing the supporting area of the end of the clamping arm for the valve leaflet, which can avoid local stress concentration of the valve leaflet at the end of the clamping arm and effectively reduce the damage to the valve leaflet caused by the repeated friction between the edge of the end of the clamping arm and the valve leaflet with the heartbeat; on the other hand, the valve leaflet also forms a fit with the arc-shaped adapting section 127, further increasing the fitting area between the valve leaflet and the adjusting part, enhancing the elastic fit between the valve leaflet and the adjusting part, making the valve leaflet fit more fully with the adjusting part. Accordingly, the adjusting part can provide a more sufficient radial supporting force for the valve leaflet, and further improve the clamping force to firmly clamp the valve leaflet.

[0097] Embodiment IV

[0098] Please refer to Figures 23 - 25, compared with the valve clamping device 100 of the first embodiment above, the structure of the adjustment part 120 of the valve clamping device 400 provided by the fourth embodiment of the present invention remains unchanged and will not be elaborated here, but the structures of the support part 410, the clamping part 430, and the driving part 440 have changed.

[0099] Specifically, in this fourth embodiment, the clamping part 430 includes at least two clamping arms, generally including at least one group of clamping arms. Each group of clamping arms includes two clamping arms symmetrically arranged with respect to the adjustment part 120. The clamping part 40 in this embodiment includes one group of clamping arms. At least one anchoring member 431 is provided on each clamping arm. When the clamping arms are closed with respect to the adjustment part 120, the anchoring member 431 can abut against the valve leaflet to embed it in the grid of the reticular adjustment part 120, so as to hold the valve leaflet tissue through the anchoring member 431 on the basis of the adjustment part 120 and the clamping arms clamping the valve leaflet.

[0100] The driving part 440 includes a driving shaft 410, an automatic closing unit 445, and at least two connecting rods 443. Wherein, one end of each said connecting rod 443 is rotatably connected to a corresponding clamping arm, and the other end is directly rotatably connected to the driving shaft 441 through a pin shaft; the driving shaft 441 is movably installed in the support part 410; the automatic closing unit 445 is connected to the two clamping arms and is used to make the clamping part 430 abut against the adjustment part 120 in the natural state.

[0101] The base 416 and the first end 411 of the support part 410 are of an integral structure, and the two clamping arms are rotatably connected to the base 416. An axial groove 419 for the pin shaft to pass through is provided on the support part 410. When the driving shaft 441 drives the pin shaft to move in the axial groove 419 towards the first end 411 of the support part 410, it drives the connecting rod 443 to overcome the obstruction of the automatic closing unit 445 and makes the two clamping arms open relative to each other.

[0102] In this embodiment, the automatic closing unit 445 is a U-shaped elastic piece. The two ends of the U-shaped elastic piece are respectively connected to a clamping arm. When the driving shaft 441 does not apply a thrust to the pin shaft, the U-shaped elastic piece uses its own reset to drive the two clamping arms to tend to close and abut against the adjustment part 120. It can be understood that in other embodiments, the automatic closing unit 445 can also be an elastic piece such as a V-shaped elastic piece or a torsion spring.

[0103] Embodiment Five

[0104] Please refer to Figure 26 , compared with the valve clamping device 400 of the fourth embodiment above, the adjustment part 120 in the fourth embodiment is replaced with the adjustment part 120' of the second embodiment, and other structures remain unchanged and will not be elaborated here.

[0105] Embodiment Six

[0106] Please refer to Figure 27 and Figure 28 In comparison with the valve clamping device 100 of the first embodiment above, the structure of the adjusting portion 120 of the valve clamping device 500 provided in the sixth embodiment of the present invention remains unchanged and will not be described herein again. However, the structures of the clamping portion 530, the driving portion 540, etc. have changed.

[0107] In this embodiment, the base 516 and the first end 511 of the support portion 510 are of an integral structure, and one end of the clamping arm of the clamping portion 530 is connected to the base 516. The driving portion 540 includes a driving shaft 541 and at least two elastic driving arms 545. One end of the elastic driving arm 545 is fixedly connected to one end of the driving shaft 541, and the other end of the elastic driving arm 545 is connected to the other end of the clamping arm. The other end of the driving shaft 545 is movably inserted into the support portion 510; the elastic driving arm 545 is used to make the clamping portion 530 abut against the adjusting portion 120 in the natural state; one end of the grasping arm 551 is connected to the clamping arm of the clamping portion 530, and in the deployed state of the valve clamping device 500, the grasping arm 551 is controlled by a pull wire (not shown in the figure) in the conveying device to open relative to the clamping arm to allow the valve leaf to enter between the grasping arm 551 and the clamping arm.

[0108] In this embodiment, the two clamping arms and the two elastic driving arms 545 are of an integral structure, that is, the two clamping arms themselves are also elastic. When the driving shaft 541 moves toward the first end 511 of the support portion 510, it overcomes the obstruction of the two elastic driving arms 545 to open the two clamping arms relatively; when the driving shaft 541 does not apply a thrust to the elastic driving arm 545, the two elastic driving arms 545 drive the two clamping arms to tend to close and abut against the adjusting portion 120 by using their own reset. It should be noted that when the driving shaft 541 continuously pushes toward the first end 511 of the support portion 510, the connection between the clamping arm and the driving arm 545 can be gradually moved closer to the driving shaft 541 until the clamping arm and the driving arm 545 are substantially in a straight line, and then the grasping arm 551 is controlled by the pull wire to fit the adjusting portion 120. In this state, it is easier to receive the entire flattened valve clamping device 500 into the sheath.

[0109] In addition, the valve clamping device 500 of this embodiment can achieve dynamic balance of the clamping state of the valve leaf: when the valve leaf applies a large pulling force to the valve clamping device 500, the elastic driving arm 545 and the clamping arm can adjust the clamping angle within a certain range without detaching from the valve leaf, preventing the valve leaf from being damaged by excessive pulling force.

[0110] Embodiment Seven

[0111] Please refer to Figure 29, when comparing the valve clamping device 500' provided in the seventh embodiment of the present invention with the valve clamping device 500 in the above-mentioned sixth embodiment, the adjusting part 120 in the sixth embodiment is replaced with the adjusting part 120' in the second embodiment, and other structures remain unchanged, which will not be elaborated here.

[0112] Embodiment Eight

[0113] Please refer to Figure 30 With Figure 31 , when comparing the valve clamping device 600 provided in the eighth embodiment of the present invention with the valve clamping device 100 in the above-mentioned first embodiment, only the structure of the support part 610 changes, and other structures remain unchanged, which will not be elaborated here.

[0114] In this embodiment, the connection part between the support part 610 and the delivery device 200' is not arranged at the second end as in the first embodiment, but a connection part 670 is arranged on the base 660 at the first end of the support part 610, and this connection part 670 is detachably connected to the push sheath of the delivery device 200'. Specifically, complementary splicing structures are respectively arranged on the connection part 670 and the push sheath of the delivery device 200'. An outer sheath 70 is movably sleeved outside the push sheath. When the outer sheath 70 wraps the complementary splicing structures, the support part 610 is connected to the delivery device 200'. When the outer sheath 70 is retracted to expose the complementary splicing structures, the connection between the support part 610 and the delivery device 200' can be released.

[0115] As Figure 31 shown, the delivery device 200' in this embodiment can push the valve clamping device 600 into the heart through the transapical approach to perform edge-to-edge repair on the mitral valve. It should be noted that before the two clamping arms are closed, the outer sheath 70 should keep wrapping the complementary splicing structures; after the two clamping arms are closed, first release the threaded connection between the mandrel and the drive shaft, retract the mandrel, and then retract the outer sheath 70 to expose the splicing structures, so as to release the connection between the valve clamping device 600 and the delivery device 200'.

[0116] It can be understood that the valve clamping system provided by the present invention includes any of the above-mentioned valve clamping devices and a delivery device that can transport the valve clamping device from outside the body to near the mitral valve and clamp the valve leaflets.

[0117] It can be understood that the valve clamping device and the valve clamping system provided by the present invention can also perform edge-to-edge repair on the tricuspid valve, as long as the corresponding intervention path (such as femoral vein - inferior vena cava - right atrium - right ventricle) is selected and the appropriate number of valve clamping devices are implanted according to the number of valve leaflets to be repaired (such as implanting three valve clamping devices to clamp the anterior leaflet and posterior leaflet, posterior leaflet and septal leaflet, septal leaflet and anterior leaflet of the tricuspid valve respectively).

[0118] The above are only specific embodiments of the present invention, enabling those skilled in the art to understand or implement the present invention. Various modifications to these embodiments will be obvious to those skilled in the art, and the general principles defined herein can be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention will not be limited to these embodiments shown herein, but rather to the broadest scope consistent with the principles and novel features claimed herein.

Claims

1. A valve clamping device with sufficient fitting, characterized in that, it includes: A support part, the support part has a certain axial length and includes a first end and a second end arranged oppositely; An adjustment part, the adjustment part includes a first end and a second end arranged oppositely, and a self-expanding body located between the first end and the second end; the first end of the adjustment part is movably sleeved outside the support part, the second end of the adjustment part is sleeved outside the support part and fixedly connected to the support part, the first end of the adjustment part is located between the first end of the support part and the second end of the adjustment part, the diameter of the self-expanding body gradually increases from the first end of the adjustment part to the second end of the adjustment part in the natural state, and the overall shape of the adjustment part is approximately an inverted cone shape; A clamping part, the clamping part is arranged outside the support part and can be expanded or closed relative to the adjustment part.

2. The valve clamping device with sufficient fitting according to claim 1, characterized in that, the self-expanding body is a net structure made of shape memory material.

3. The valve clamping device with sufficient fitting according to claim 2, characterized in that, the outside and / or inside of the net structure is covered with a biocompatible film.

4. The valve clamping device with sufficient fitting according to claim 1, characterized in that, the self-expanding body has a concave area connected to the second end of the adjustment part, and the end of the concave area extends towards the first end of the support part to the second end of the adjustment part, or the end of the concave area extends towards the second end of the support part to the second end of the adjustment part.

5. The valve clamping device with sufficient fitting according to claim 4, characterized in that, it further includes a fixing part, and the second end of the adjustment part is inserted and fixed in the fixing part to be fixedly connected to the support part through the fixing part.

6. The valve clamping device with sufficient fitting according to claim 1, characterized in that, the self-expanding body includes a first section, a second section and a third section connected in sequence; the first section extends from the second end of the adjustment part towards the second end of the support part, and the first section surrounds the outside of the second end of the support part; the second section continues to extend radially outwards from the first section; the third section extends radially inwards from the second section towards the first end of the support part and stops at the first end of the adjustment part.

7. The valve clamping device with sufficient fitting according to claim 6, characterized in that, the self-expanding body further includes a bending section, and the bending section is connected between the second end of the adjustment part and the first section.

8. The valve clamping device with sufficient fitting according to claim 6, characterized in that, the radial dimension range of the second section of the self-expanding body is 4mm - 15mm, and the radial dimension range of the first end of the adjustment part is 1mm - 5mm.

9. The valve clamping device with sufficient fitting according to any one of claims 1 to 8, characterized in that, The valve clamping device further includes a driving part. The clamping part includes at least two clamping arms, and the at least two clamping arms are symmetrically arranged with respect to the adjusting part. The driving part is respectively connected to each clamping arm to drive each clamping arm to approach or move away from the adjusting part.

10. The valve clamping device with sufficient fitting according to claim 9, wherein, A base is provided at the first end of the support part, and each clamping arm is rotatably connected to the base. There is an axial distance between the first end of the support part and the first end of the adjusting part.

11. The valve clamping device with sufficient fitting according to claim 10, wherein, The driving part includes: a driving shaft, a connecting seat and at least two connecting rods; wherein, one end of each connecting rod is rotatably connected to a clamping arm, and the other end of each connecting rod is rotatably connected to the connecting seat; one end of the driving shaft is connected to the connecting seat, and the other end of the driving shaft is movably inserted into the base.

12. The valve clamping device with sufficient fitting according to claim 11, wherein, The valve clamping device further includes a locking part arranged in the base, and the locking part restricts the relative movement between the driving shaft and the base.

13. The valve clamping device with sufficient fitting according to claim 10, wherein, The driving part includes: a driving shaft, an automatic closing unit and at least two connecting rods; the driving shaft is movably inserted into the support part, one end of each connecting rod is rotatably connected to a clamping arm, and the other end of each connecting rod is rotatably connected to the driving shaft; the automatic closing unit is connected to the clamping arm for making the clamping arm abut against the adjusting part in a natural state.

14. The valve clamping device with sufficient fitting according to claim 10, wherein, The driving part includes a driving shaft and at least two elastic driving arms. One end of the driving shaft is movably inserted into the support part, one end of each elastic driving arm is fixedly connected to the other end of the driving shaft, and the other end of each elastic driving arm is respectively connected to a clamping arm; the elastic driving arm is used for making the clamping arm abut against the adjusting part in a natural state.

15. The valve clamping device with sufficient fitting according to claim 9, wherein, A flanging section is provided at the end of the clamping arm. The flanging section is an arc surface that turns outward toward the end of the clamping arm. After the clamping arm abuts against the adjusting part, the self-expanding body protrudes axially from the flanging section.

16. The valve clamping device with sufficient fitting according to claim 15, wherein, The self-expanding body is provided with an adapting section corresponding to the flanging section, and the shape of the side of the adapting section facing the flanging section is complementary to the arc surface.

17. The valve clamping device with sufficient fitting according to any one of claims 1 to 8, wherein, The valve clamping device further includes a grasping part, and the grasping part is arranged between the clamping part and the adjusting part and can be expanded or closed relative to the support part.

18. A valve clamping system, wherein, Comprising the well-fitted valve clamping device according to any one of claims 1 to 17, and a delivery device, the delivery device comprising: a push sheath having a certain axial length and a mandrel movably inserted into the push sheath, the push sheath being detachably connected to the support portion, and the mandrel being used for driving the deployment and closing of the clamping portion.

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