Adaptive Valve Clamping Device and Valve Clamping System

Abstract

The present application discloses an adaptive valve clamping device and a valve clamping system. The adaptive valve clamping device includes a support portion, a hollow adjustment portion, and a clamping portion. The support portion includes a first seat body and a second seat body. The first seat body is disposed within the adjustment portion. The adjustment portion includes an opposite first end and a second end, and a self-expanding body located between the first end and the second end. The first end is movably sleeved outside the second seat body and can axially move relative to the second seat body, and the second end is suspended. The first seat body is closer to the second end of the adjustment portion than the second seat body. The clamping portion includes at least two clamping arms, each clamping arm is rotatably connected to the support portion, the position where the clamping arm is rotatably connected is close to the first end of the adjustment portion, and the clamping arm rotates around the support portion to approach or move away from the adjustment portion. This adaptive valve clamping device can increase the space at the position where the clamping arm is rotatably connected close to the adjustment portion, and at this position, the adjustment portion can better adapt to the deformation of the valve leaflets and avoid damaging the valve leaflets at this position.

Description

Technical Field

[0001] This application relates to the technical field of implantable medical devices, and particularly to an adaptive valve clamping device and a valve clamping system including the adaptive valve clamping device. Background Art

[0002] Refer to Figure 1 , the mitral valve MV is a one-way valve located between the left atrium LA and the left ventricle LV of the heart. A normal and healthy mitral valve MV can control the blood flow from the left atrium LA to the left ventricle LV, while preventing the blood from flowing from the left ventricle LV to the left atrium LA. The mitral valve MV includes a pair of valve leaflets, called the anterior leaflet AML and the posterior leaflet PML. The anterior leaflet AML and the posterior leaflet PML are fixed to the papillary muscles of the left ventricle LV through chordae tendineae. Under normal circumstances, when the left ventricle LV of the heart contracts, the edges of the anterior leaflet AML and the posterior leaflet PML are completely opposed to avoid blood flowing from the left ventricle LV to the left atrium LA. Refer to Figure 2 , when there are organic or functional changes in the valve leaflets or their related structures of the mitral valve MV, such as partial rupture of the chordae tendineae, the anterior leaflet AML and the posterior leaflet PML of the mitral valve MV are poorly opposed. As a result, when the left ventricle LV of the heart contracts, the mitral valve MV cannot be completely closed, leading to blood reflux from the left ventricle LV to the left atrium LA, thereby causing a series of pathophysiological changes, known as "mitral regurgitation".

[0003] Mitral valve percutaneous edge-to-edge repair refers to using a valve clamping device to pull the anterior and posterior leaflets towards each other through a pair of rotatably connected and closable clamping arms, reducing or eliminating the leaflet gap to treat mitral regurgitation. In an existing valve clamping device, an elastomer is added to the two clamping arms. Each side of the valve leaflet is respectively clamped between one side of a clamping arm and one side of the elastomer. The elastomer is used to fill the gap between the two clamping arms, reduce central reflux, and adapt to the distance between the valve leaflets through the deformation of the elastomer, thereby adjusting the pulling degree of the clamping arms on the valve leaflets. However, when the clamping arms are closed, the space is smaller closer to the connection of the clamping arms. When the valve leaflets are grasped by the clamping arms, part of the valve leaflets will accumulate and fill this space, thus affecting the closing of the clamping arms. At the same time, if the filling situation of the valve leaflets at this place cannot be detected in time through medical imaging, when the operator forcibly closes the clamping device, the clamping arms will damage the valve leaflets at this place. Summary of the Invention

[0004] In order to solve the above technical problems or at least partially solve the above technical problems, this application provides an adaptive valve clamping device and a valve clamping system including the adaptive valve clamping device.

[0005] In a first aspect, this application provides an adaptive valve clamping device, comprising:

[0006] A support part, the support part includes a first seat body and a second seat body connected to the first seat body;

[0007] A hollow adjusting part, the first seat body is arranged inside the adjusting part. The adjusting part includes an opposite first end and a second end, 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 second seat body and can axially move relative to the second seat body. The second end of the adjusting part is suspended, and the first seat body is closer to the second end of the adjusting part than the second seat body;

[0008] A clamping part, the clamping part includes at least two clamping arms, each clamping arm is rotatably connected to the support part, and the position where the clamping arm is rotatably connected is close to the first end of the adjusting part. The clamping arm rotates around the support part to approach or move away from the adjusting part.

[0009] In a second aspect, the present application provides a valve clamping system, including the above-mentioned adaptive valve clamping device and a delivery device. The delivery device includes a push shaft with a certain axial length and a mandrel movably inserted into the push shaft. The push shaft is detachably connected to the support part, and the mandrel is used to drive the clamping arm to rotate around the support part.

[0010] In a third aspect, the present application further provides a valve clamping system, including the above-mentioned adaptive valve clamping device and a delivery device. The delivery device includes a push shaft with a certain axial length and a mandrel movably inserted into the push shaft. The push shaft is detachably connected to the support part, and the mandrel is used to drive the clamping arm to rotate around the support part;

[0011] The delivery device further includes an operating wire, the operating wire passes through at least one of the mesh holes and enters the cavity of the self-expanding body, and is detachably connected to the first connecting section and the second connecting section.

[0012] In the adaptive valve clamping device provided by the embodiments of the present application and the valve clamping system including the adaptive valve clamping device, the first end of the adjusting part is movably sleeved outside the second seat body of the support part, the second end of the adjusting part is suspended and relatively closer to the first seat body, and the adjusting part can axially move relative to the support part. When the clamping arms of the clamping part approach the adjusting part to close and clamp the valve leaflets, the whole adjusting part moves axially towards the first seat body, which can increase the space at the position where the clamping arm is rotatably connected close to the adjusting part, and avoid excessive accumulation of valve leaflets in this space. During the closing process of the clamping part, the adjusting part at this position can better adapt to the deformation of the valve leaflets, so as to adjust the overall traction of the clamping part on the valve leaflets, make the axial force of the valve leaflets more balanced, and is beneficial to the better closing of the clamping part after grasping the valve leaflets, and avoid damaging the valve leaflets at this position. Description of the Drawings

[0013] The accompanying drawings here are incorporated into the specification and constitute a part of this specification, showing embodiments in line with this application, and are used together with the specification to explain the principles of this application.

[0014] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the following will briefly introduce the accompanying 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 accompanying drawings can also be obtained based on these drawings.

[0015] Figure 1 It is a schematic diagram of the normal state of the mitral valve;

[0016] Figure 2 It is a schematic diagram of the mitral valve when it is diseased;

[0017] Figure 3 It is a schematic structural diagram of the adaptive valve clamping device in the first embodiment of this application;

[0018] Figure 4 It is a schematic structural diagram of the adaptive valve clamping device in the first embodiment of this application in the open state;

[0019] Figure 5 It is a schematic structural diagram of the adaptive valve clamping device in the first embodiment of this application in the closed state;

[0020] Figure 6 It is Figure 4 The schematic structural diagram after the combination of the adjusting part and the supporting part in;

[0021] Figure 7 It is Figure 4 The schematic structural diagram of the adjusting part in;

[0022] Figures 8 - 10 It is a schematic diagram of different structures of the adjusting part in the first embodiment of this application;

[0023] Figure 11 Another schematic structural diagram of the adaptive valve clamping device in the first embodiment of this application;

[0024] Figure 12 It is a schematic structural diagram of the supporting part in the first embodiment of this application;

[0025] Figure 13 It is Figure 12 The schematic structural diagram of the first seat body in;

[0026] Figure 14 It is Figure 12 The schematic structural diagram of the third seat body in;

[0027] Figure 15Schematic diagram of the connection between the conveying device and the supporting part in the first embodiment of the present application;

[0028] Figure 16 It is Figure 15 Enlarged schematic diagram of part I in;

[0029] Figures 17 - 21 It is the use of Figure 4 Schematic diagram of the process of approaching and repairing the mitral valve anterogradely through the left atrium by the adaptive valve clamping device in;

[0030] Figure 22 And Figure 23 Schematic diagram of the structure of the supporting part and the adjusting part in the second embodiment of the present application;

[0031] Figure 24 Schematic diagram of the structure of the supporting part in the second embodiment of the present application;

[0032] Figure 25 Another schematic diagram of the structure of the supporting part and the adjusting part in the second embodiment of the present application;

[0033] Figure 26 Exploded schematic diagram of the adjusting part in the third embodiment of the present application;

[0034] Figure 27 Exploded schematic diagram of the supporting part in the third embodiment of the present application;

[0035] Figure 28 Schematic diagram of the structure of the adaptive valve clamping device in the fourth embodiment of the present application;

[0036] Figure 29 Another schematic diagram of the structure of the adaptive valve clamping device in the fourth embodiment of the present application;

[0037] Figure 30 Partial schematic diagram of the structure of the adaptive valve clamping device in the fourth embodiment of the present application;

[0038] Figure 31 Schematic diagram of the structure of the valve clamping system in the fourth embodiment of the present application. Detailed implementation manners

[0039] Next, the technical solutions in the embodiments of the present application will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present application.

[0040] In the description of the present application, it should be noted that 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 drawings. It is only for the convenience of describing the present application 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. Therefore, it should not be construed as a limitation to the present application. In addition, terms such as "first", "second", etc. are only used for descriptive purposes and cannot be construed as indicating or implying relative importance.

[0041] 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.

[0042] In the description of the present application, it should 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 axial direction refers to the direction parallel to the line connecting the centers of the distal end and the proximal end of the medical device. The above definitions are only for the convenience of expression and should not be construed as a limitation to the present application. The "ends" in words such as "proximal end", "distal end", "one end", "the other end", "terminal end", "first end", "second end", etc. not only refer to the end, endpoint or end face of the element, but also include the part that extends a certain axial distance or radial distance on the element to which the end, endpoint or end face belongs from the end, endpoint or end face.

[0043] Embodiment 1

[0044] Please refer to Figures 3 - 5 , an adaptive valve clamping device 100 provided by Embodiment 1 of the present application can be used for edge-to-edge repair of the mitral valve or tricuspid valve to treat mitral regurgitation or tricuspid regurgitation. To ensure the safety of the adaptive valve clamping device 100 after implantation, the entire adaptive valve clamping device 100 is made of biocompatible materials. The following takes the adaptive valve clamping device 100 for edge-to-edge repair of the mitral valve as an example for detailed description. The operator uses the delivery device 200 to push the adaptive valve clamping device 100 to the mitral valve of the patient, and then remotely operates the adaptive valve clamping device 100 to clamp the anterior leaf and posterior leaf of the mitral valve together. When the valve leaflets of the mitral valve are edge-to-edge opposed to each other, the operator can release the connection between the delivery device 200 and the adaptive valve clamping device 100, thereby implanting the adaptive valve clamping device 100 into the patient's body and fixing the anterior leaf and posterior leaf of the mitral valve together to achieve "edge-to-edge repair" of the mitral valve.

[0045] Please combine Figure 6, the adaptive valve clamping device 100 includes a support portion 110, a hollow adjustment portion 120, and a clamping portion 130. The support portion 110 includes a first base body 112 and a second base body 114 connected to the first base body 112. The first base body 112 is disposed within the adjustment portion 120. The adjustment portion 120 includes an opposite first end 122 and a second end 124, and a self-expanding body 121 located between the first end 122 and the second end 124. The first end 122 of the adjustment portion 120 is movably sleeved outside the second base body 114 and can axially move relative to the second base body 114, and the second end 124 of the adjustment portion 120 is suspended. The first base body 112 is closer to the second end 124 of the adjustment portion 120 than the second base body 114. The clamping portion 130 includes at least two clamping arms 132, and each clamping arm 132 is rotatably connected to the support portion 110. The portion where the clamping arm 132 is rotatably connected is close to the first end 122 of the adjustment portion 120, and the clamping arm 132 rotates around the support portion 110 to approach or move away from the adjustment portion 120.

[0046] In the adaptive valve clamping device 100 of the above embodiment, the first end 122 of the adjustment portion 120 is movably sleeved outside the second base body 114 of the support portion 110, the second end 124 of the adjustment portion 120 is suspended and relatively closer to the first base body 112, the adjustment portion 120 can axially move relative to the support portion 110. When the clamping arms 132 of the clamping portion 130 approach the adjustment portion 120 to close and clamp the valve leaflets, the entire adjustment portion 120 moves axially towards the first base body 112, which can increase the space A at the portion where the clamping arms 132 are rotatably connected close to the adjustment portion 120, and avoid excessive accumulation of valve leaflets in the space A. During the closing process of the clamping portion 130, the adjustment portion 120 at this place can better adapt to the deformation of the valve leaflets, thereby adjusting the overall pulling force of the clamping portion 130 on the valve leaflets, making the axial force on the valve leaflets more balanced, which is beneficial for the clamping portion 130 to better close after grasping the valve leaflets and avoiding damage to the valve leaflets at this place.

[0047] It can be understood that the clamping arms 132 of the clamping portion 130 are rotatably connected to the support portion 110, and the first end 122 of the adjustment portion 120 is movably sleeved outside the second base body 114 of the support portion 110, that is, the clamping portion 130 is disposed outside the adjustment portion 120. The clamping arms 132 of the clamping portion 130 rotate around the support portion 110 to approach the adjustment portion 120, that is, the clamping portion 130 closes relative to the adjustment portion 120; the clamping arms 132 of the clamping portion 130 rotate around the support portion 110 to move away from the adjustment portion 120, that is, the clamping portion 130 opens relative to the adjustment portion 120.

[0048] The second end 124 of the adjusting portion 120 is suspended and closer to the first seat body 112 of the supporting portion 110. The first seat body 112 is disposed within the adjusting portion 120. Then, there is a gap between the second end 124 of the adjusting portion 120 and the first seat body 112 of the supporting portion 110, which can prevent interference or entanglement between the second end 124 of the adjusting portion 120 and the first seat body 112 of the supporting portion 110, ensuring the safe implantation of the instrument. The self-expanding body 121 of the adjusting portion 120 can deform both radially and axially. Therefore, the adjusting portion 120 includes a natural state and a compressed state. The self-expanding body 121 can be made of a shape memory material. When the clamping portion 130 opens relative to the adjusting portion 120, the clamping portion 130 has no contact with the adjusting portion 120, and the adjusting portion 120 is in a natural state. When the clamping portion 130 closes relative to the adjusting portion 120, the adjusting portion 120 is radially compressed and axially extends toward the first seat body 112 of the supporting portion 110, presenting a compressed state. During the process of the clamping portion 130 closing relative to the adjusting portion 120, the adjusting portion 120 is gradually radially compressed and axially extends toward the first seat body 112 of the supporting portion 110, and the gap between the second end 124 of the adjusting portion 120 and the first seat body 112 of the supporting portion 110 gradually increases. Since the first end 122 of the adjusting portion 120 is movably sleeved outside the second seat body 114 of the supporting portion 110, the first end 122 of the adjusting portion 120 also moves toward the first seat body 112 of the supporting portion 110, thereby increasing the space A at the position where the clamping arm 132 is rotatably connected and close to the first end 122 of the adjusting portion 120, preventing excessive accumulation of valve leaflets in the space A, and ensuring normal closing of the clamping portion 130 without damaging the valve leaflets.

[0049] Meanwhile, since the first end 122 of the adjusting portion 120 is movably sleeved outside the second seat body 114 of the supporting portion 110 and the second end 124 of the adjusting portion 120 is suspended, the adjusting portion 120 is no longer restricted by the supporting portion 110, improving the axial deformation ability of the adjusting portion 120 and enhancing its bending deformation ability along the axial direction. Therefore, when the adaptive valve clamping device 100 is radially compressed into the delivery sheath for in-vivo delivery, it is not only easily compressed into the sheath, but also can adapt to blood vessels with different bending curvatures during delivery in the blood vessel, thus facilitating the passage of the delivery sheath in the blood vessel, thereby reducing damage to the blood vessel wall. The first end 122 of the adjusting portion 120 is movably sleeved outside the second seat body 114 of the supporting portion 110, and the second end 124 of the adjusting portion 120 is suspended, making the center of gravity of the adjusting portion 120 always located on the axis of the supporting portion 110 (i.e., the axis line of the adjusting portion 120). Therefore, the self-centering property of the adjusting portion 120 is good and it is not easy to tilt.

[0050] In addition, after the adaptive valve clamping device 100 is implanted, during the process of clamping the leaflet and the regulating part 120 by the clamping part 130, the axial deformation of the regulating part 120 is not restricted, so the elastic fit between the leaflet and the regulating part 120 can be improved, thereby improving the adaptability of the leaflet physiological structure to different patients.

[0051] Please combine Figures 17 - 21 In the adaptive valve clamping device 100 of this embodiment, the support portion 110 and the delivery device 200 are detachably connected (such as threaded connection, snap connection, etc.), and the delivery device 200 pushes the adaptive valve clamping device 100 into the heart through a catheter, then the second end 124 of the adjustment portion 120 is its proximal end, and the first end 122 of the adjustment portion 120 is its distal end; the first seat body 112 of the support portion 110 is close to the proximal end of the adaptive valve clamping device 100, and the second seat body 114 is close to the distal end of the adaptive valve clamping device 100. It can be understood that in other embodiments, the adaptive valve clamping device 100 can be inserted into the heart through the apex, the second end 124 of the adjustment portion 120 is its distal end, and the first end 122 of the adjustment portion 120 is its proximal end; the first seat body 112 of the support portion 110 is close to the distal end of the adaptive valve clamping device 100, and the second seat body 114 is close to the proximal end of the adaptive valve clamping device 100.

[0052] The adaptive valve clamping device 100 is in a closed state during delivery, and can be released and opened to clamp the leaflets when delivered to the mitral valve in the patient's body. The first seat body 112 of the support part 110 is located in the hollow adjustment part 120, whether in the delivery state or in the released and opened state, and will never be exposed in the delivery device 200 or in the heart, thereby avoiding blood flushing and minimizing the formation of thrombus after implantation. Moreover, after the adaptive valve clamping device 100 is implanted, direct contact between the support part 110 and the leaflets is avoided. With the long-term pulsation of the leaflets, the support part 110 is prevented from wearing the leaflets or even causing leaflet perforation, thereby improving safety.

[0053] See also Figure 6 and Figure 7 The first end 122 of the adjusting part 120 is provided with a first end cap 126, and the first end cap 126 is movably sleeved on the outer side of the second seat body 114. The inner cavity surface of the first end cap 126 is clearance-matched with the outer surface of the second seat body 114. In this way, the first end 122 of the adjusting part 120 is gathered by the first end cap 126, and the first end cap 126 can move on the second seat body 114 of the supporting part 110, so that the adjusting part 120 can move relative to the supporting part 110.

[0054] Specifically, the first head 126 has a double-layer structure and includes two coaxially nested tubes. Among them, the sandwich cavity between the two tubes is closed at one end and open at the other end for receiving the first end 122 of the adjustment portion 120. Both ends of the tube with a smaller radial dimension are open, and its inner cavity is the inner cavity of the first head 126. The first head 126 can be a metal steel sleeve.

[0055] To ensure that the adjustment portion 120 can be movably sleeved on the second seat body 114 of the support portion 110, the clearance range between the inner cavity surface of the first head 126 and the outer surface of the second seat body 114 is 0.01 - 3 mm, preferably 0.05 - 3 mm. More preferably, the clearance range between the inner cavity surface of the first head 126 and the outer surface of the second seat body 114 is 0.05 - 1 mm to avoid excessive clearance causing the first head 126 and the adjustment portion 120 to shake outside the support portion 110. Even more preferably, the clearance range between the inner cavity surface of the first head 126 and the outer surface of the second seat body 114 is 0.05 - 0.2 mm. In this way, it can not only avoid excessive clearance causing the first head 126 to freely slide and rotate on the second seat body 114, but also enable the first head 126 to axially move relative to the second seat body 114 by applying an appropriate force to the first head 126 and / or the second seat body 114.

[0056] Furthermore, the surface roughness range of the inner cavity surface of the first head 126 is 0.1 - 2.5 microns, and / or the surface roughness range of the outer surface of the second seat body 114 is 0.1 - 2.5 microns. It can be understood that setting the inner cavity surface of the first head 126 and / or the outer surface of the second seat body 114 to be rough, making the contact surface between the first head 126 and the second seat body 114 not smooth, can further ensure the effect of restricting the first head 126 from freely sliding and rotating on the second seat body 114. By reasonably setting the surface roughness range, the first head 126 can still axially move relative to the second seat body 114 by applying an appropriate force to the first head 126 and / or the second seat body 114.

[0057] The second end 124 of the adjustment portion 120 has an opening 128, which facilitates the conveying device 200 to penetrate into the adjustment portion 120 and connect with the support portion 110. At the same time, no components such as a head are exposed at the second end 124, which can avoid thrombus formation and wear of the valve leaf. The size of the opening 128 is less than or equal to the size of the first seat body 112 of the support portion 110, ensuring that the first seat body 112 of the support portion 110 will not protrude from the adjustment portion 120 in both the natural state and the compressed state.

[0058] The self-expanding body 121 of the adjusting part 120 has a hollow accommodating cavity, and the first seat body 112 of the supporting part 110 is arranged in the hollow accommodating cavity. In one embodiment, the self-expanding body 121 is a hollow mesh structure with a plurality of mesh holes. The mesh structure is formed by weaving or cutting a shape memory material, and metal materials, polymer materials, or metal-polymer composite materials can be selected. It is preferably made of shape memory metal materials such as stainless steel, cobalt-chromium alloy, or nickel-titanium with certain elasticity. For example, a superelastic nickel-titanium alloy material can be selected for weaving or cutting, and after heat setting treatment, it forms a natural state. Specifically, all the wire filaments of the mesh structure are fixedly gathered at the sandwich cavity of the first head 126 at the first end 122, and the folded parts at the edge of the second end 124 of all the wire filaments of the mesh structure enclose to form an opening 128. The shape of the folding can be set as needed, such as one-time folding, or multiple winding to form at least one ring and then winding back, etc. Further, please refer to Figure 7 , the adjusting part 120 further includes an annular structure 123 arranged at the edge of the second end 124 to stabilize the morphology of the opening 128, and all the wire filaments of the mesh structure at the second end 124 are wound and connected with the annular structure 123. The annular structure 123 is made of a flexible or elastic material, and its wire diameter is larger than that of the wire filaments of the woven mesh structure, so as to provide a certain supporting force for the opening 128 of the mesh structure, but does not affect the axial deformation ability and bending ability of the mesh structure. A polytetrafluoroethylene (PTFE) coating can be applied to the surface of the nickel-titanium alloy by spraying, dipping, etc., so as to have excellent corrosion resistance, chemical resistance, and wear resistance. Therefore, it can play the performance of surface protection, anti-corrosion, and extending the service life of parts. At the same time, because PTFE has a good friction coefficient, it can effectively reduce the damage of the self-expanding body 121 to the valve leaflets.

[0059] Of course, the self-expanding body 121 of the adjusting part 120 can be other elastic hollow structures. For example, the self-expanding body 121 can be a dense structure or a porous structure. The dense structure is a silica gel body, and the porous structure is a sponge body. An opening 128 is formed at the edge of the second end 124 of the dense structure or the porous structure, and a first head 126 is provided at the first end 122.

[0060] For the self-expanding body 121 with a dense structure, since the self-expanding body 121 is filled between the anterior and posterior leaflets of the mitral valve, it can completely prevent the scouring of the internal part of the adaptive valve clamping device 100 by the blood flow, and avoid the shedding of the adaptive valve clamping device 100 due to the scouring of high-speed flowing blood during the fine-tuning process, as well as the shedding of the clamping part 130 after implantation due to the continuous impact of the blood, and avoid the formation of thrombus due to the accumulation of blood in the dead corner between the clamping parts 130 of the adaptive valve clamping device 100. For the self-expanding body 121 with a reticular structure, it has better elastic deformation ability, can better adapt to the anatomical structure of the mitral valve, and avoid leaflet damage caused by excessive traction of the leaflets.

[0061] Furthermore, a coating film (not shown in the figure) is applied to at least part of the outer surface of the self-expanding body 121 with a reticular structure. The coating film can be a woven reticular structure with multiple mesh holes. The self-expanding body 121 with the coating film can not only further improve the blood flow blocking effect, reduce central regurgitation, but also increase biocompatibility, avoid valve tissue allergy and inflammatory reactions, improve product safety, and can form an artificial barrier on the atrial side of the leaflets to block the thrombus formed by the repeated scouring of the blood at the internal dead corner of the adaptive valve clamping device 100 from flowing out. The coating film material can be made of high molecular materials such as polyethylene glycol terephthalate (PET), polypropylene (PP), polytetrafluoroethylene, polyurethane, etc. Preferably, the coating film material is made of PET.

[0062] To avoid the self-expanding body 121 affecting the relative opening and closing between the clamping part 130 and the supporting part 110 and thus affecting the clamping effect on the leaflets, the diameter of the part of the self-expanding body 121 close to the first end 122 should be smaller than the diameter of other parts of the self-expanding body 121. For example, in Figure 7 the example, the middle part of the self-expanding body 121 is columnar, and both ends are conical, and the cone angles of the two conical ends are the same. It can be understood that the self-expanding body 121 can also be of any other shape, as long as the diameter of the part close to the first end 122 does not affect the clamping effect. For example, Figure 8 the spindle-shaped structure with the same cone angles at both ends shown in Figure 9 or the structure with different cone angles at both ends shown in

[0063] Please refer to Figure 10 and Figure 11The self-expanding body 121 may include a plurality of first curved surfaces 1212 and a plurality of second curved surfaces 1214, wherein the first curved surfaces 1212 and the second curved surfaces 1214 are adjacent to each other and smoothly connected together, that is, the first curved surface 1212 is only adjacent to the second curved surface 1214, and the second curved surface 1214 is also only adjacent to the first curved surface 1212, and one end of the plurality of first curved surfaces 1212 and the plurality of second curved surfaces 1214 are connected to each other and form an opening 128. The first curved surface 1212 faces the clamping portion 130, and the area of ​​the second curved surface 1214 is smaller than the area of ​​the first curved surface 1212. As the adaptive valve clamping device 100 is closed, the first curved surface 1212 is squeezed by the clamping portion 130 and the leaflet, and the regulating portion 120 extends along the axial direction and gradually fits the leaflet to ensure the contact area with the leaflet, thereby better adapting to the shape of the leaflet. By increasing the contact area between the first curved surface 1212 and the leaflets, the gap between the adaptive valve clamping device 100 and the leaflets is reduced, thereby slowing down the blood flow and preventing the blood flow from scouring the adaptive valve clamping device 100. Preferably, the curvature of the first curved surface 1212 may be greater than the curvature of the second curved surface 1214, so that the self-expanding body 121 presents a flat ellipsoid shape, avoiding affecting the closure of the clamping portion 130 and better adapting to the anatomical structure of the leaflets.

[0064] In other embodiments, the first end 122 of the adjusting portion 120 is provided with a first end cap 126, and the second end 124 of the adjusting portion 120 is provided with a second end cap. The inner cavity surface of the first end cap 126 is clearance-matched with the outer surface of the second seat body 114. In this way, the first end 122 and the second end 124 of the adjusting portion 120 are both closed by the end cap. In this embodiment, the specific structure of the second end cap is the same as that of the first end cap 126, both of which are the aforementioned double-layer structures, and will not be repeated here.

[0065] See also Figure 12 , the support portion 110 further includes a third seat body 116 connected to the second seat body 114. The inner diameter of the first end cap 126 is smaller than the outer diameter of the first seat body 112, and the inner diameter of the first end cap 126 is smaller than the outer diameter of the third seat body 116. In this way, the first end cap 126 of the first end 122 of the adjustment portion 120 is limited in its movable travel by the first seat body 112 and the third seat body 116, and the adjustment portion 120 can move axially on the second seat body 114 and will not fall off from the second seat body 114. Since the adjustment portion 120 has a certain weight, under the action of gravity, the initial position of the adjustment portion 120 is located at the distal end of the second seat body 114 and close to the proximal end of the third seat body 116.

[0066] Specifically, the inner diameter of the first head 126 should be at least 0.01 mm smaller than the outer diameter of the first seat body 112, preferably 0.05-3 mm. The inner diameter of the first head 126 should be at least 0.01 mm smaller than the outer diameter of the third seat body 116, preferably 0.05-3 mm. The first head 126 and the second seat body 114 can both be round tube structures, which facilitates the axial movement of the first head 126 on the second seat body 114. The first seat body 112 and the second seat body 114 can be integrally formed or separately formed and then welded and fixed. The third seat body 116 and the second seat body 114 can be fixed together by common detachable or non-detachable connection methods such as welding, bonding, threaded connection, crimping, bolt locking, etc., and the present embodiment adopts welding connection. Specifically, the distal end of the second seat body 114 of the supporting portion 110 can be inserted from the second end 124 of the adjusting portion 120 and out from the first end 122 of the adjusting portion 120, and then the distal end of the third seat body 116 is connected to the proximal end of the second seat body 114 by welding.

[0067] In other embodiments, the support portion 110 further includes a third seat body 116 connected to the second seat body 114. A stopper (not shown) is provided at the end of the second seat body 114 connected to the first seat body 112. The inner diameter of the first end cap 126 is smaller than the outer diameter of the stopper, and the inner diameter of the first end cap 126 is smaller than the outer diameter of the third seat body 116. In this way, the first end cap 126 at the first end 122 of the adjustment portion 120 is limited in its movable travel by the stopper and the third seat body 116, and the adjustment portion 120 can move axially on the second seat body 114 without falling off from the second seat body 114.

[0068] See also Figures 12 - 16 The support portion 110 is provided with a through passage 111 in the axial direction to cooperate with the driving portion 140 and the conveying device 200. The first seat body 112 and the second seat body 114 are both round tubes with both ends axially penetrated. The tube wall of the first seat body 112 is provided with at least two clamping positions 1122 for detachably connecting with the clamping platform 222 of the conveying device 200. The clamping platform 222 of the conveying device 200 (see Figure 16 ) After being snapped into the snap position 1122, the delivery device 200 is snap-connected with the support portion 110, and the adaptive valve clamping device 100 can be delivered. When the card platform 222 is disengaged from the snap position 1122, the delivery device 200 is separated from the adaptive valve clamping device 100 and released in the body.

[0069] The distal end of the third body 116 has a square structure, and the proximal end has a frustum structure. A receiving cavity 1162 is radially formed in the distal end of the third body 116 and penetrates through the opposite two side surfaces of the third body 116. Through holes axially penetrating the receiving cavity 1162 are formed in the proximal and distal ends of the second body 114. On the two opposite planes of the frustum structure at the proximal end of the second body 114, a connecting block 1164 is respectively protruded, and the connecting block 1164 is provided with a connecting hole for rotatably connecting with the clamping portion 130. The lumen of the first body 112, the lumen of the second body 114, the through hole of the third body 116, and the receiving cavity 1162 are communicated to form a threading channel 111. It should be understood that the structure of the supporting portion 110 here is only for example and is not a limitation to this application. Other structures of the supporting portion 110 adopted by those of ordinary skill in the art based on the teachings of this application are within the protection scope of this application.

[0070] Please refer to Figure 3 and Figure 4 , the clamping portion 130 is rotatably connected to the third body 116 of the supporting portion 110. The clamping portion 130 includes at least two clamping arms 132, that is, at least two clamping arms 132 are rotatably connected to the third body 116 of the supporting portion 110, and the at least two clamping arms 132 are circumferentially symmetrically arranged with respect to the adjusting portion 120. Further, the adaptive valve clamping device further includes a driving portion 140, and the driving portion 140 is respectively connected to each clamping arm 132 to drive each clamping arm 132 to rotate around the supporting portion 110, so as to drive each clamping arm 132 to approach the adjusting portion 120 to close or move away from the adjusting portion 120 to open. Each clamping arm 132 can be rotatably connected together on the third body 116 through a connecting shaft 134. The connecting shaft 134 passes through each clamping arm 132 and the connecting hole on the third body 116, so as to rotatably connect the clamping arm 132 to the third body 116. Further, under the drive of the driving portion 140, each clamping arm 132 cooperates with each other to rotate relative to the supporting portion 110 to open or close. When the clamping arms 132 are closed, the second end 124 of the adjusting portion 120 is slightly lower than the end surface of the free end (i.e., the proximal end) of the clamping arms 132; in this way, the adjusting portion 120 is not exposed on the proximal end surface after the clamping arms 132 are closed, ensuring that the end of the everted clamping arm 132 abuts against the valve leaf to increase the valve leaf contact area, conform to the angle and direction of the valve leaf, and avoid excessive exposure of the adjusting portion 120 in the left atrium, resulting in the risk of thrombosis.

[0071] In the illustrated example, the clamping portion 130 includes two clamping arms 132 that are circumferentially symmetrically arranged relative to the adjusting portion 120 and are used to clamp two leaflets of the mitral valve. In other embodiments, the clamping portion 130 may include three clamping arms 132 that are circumferentially arranged around the adjusting portion 120 and are used to clamp three leaflets of the tricuspid valve. It should be understood that this is only for illustration purposes here, and those of ordinary skill in the art can select an appropriate number of clamping arms 132 according to needs, such as two, three or more clamping arms 132. In the delivery state, the driving portion 140 drives the clamping arms 132 to close around the adjusting portion 120, thereby reducing the outer diameter of the adaptive valve clamping device 100 and facilitating delivery; after the adaptive valve clamping device 100 is opened in the body, the driving portion 140 drives the clamping arms 132 to clamp the leaflets between the clamping arms 132 and the adjusting portion 120 to achieve leaflet clamping.

[0072] Further, the adaptive valve clamping device 100 further includes a grasping portion 150. The grasping portion 150 is disposed between the clamping arms 132 and the adjusting portion 120 and can be close to or away from the clamping arms 132. In the natural state, at least a part of the grasping portion 150 is received in the inner surface of the clamping arms 132 (as Figure 3 shown). It can be understood that in some embodiments, the grasping portion 150 has a shape memory function, so that it can be close to the clamping arms 132 in the natural state; in other embodiments, the grasping portion 150 can be made of a material without a shape memory function, and the grasping portion 150 is driven to be close to the clamping arms 132 by means of a push rod or the like. The grasping portion 150 includes at least two grasping arms 152. Generally, the number of grasping arms 152 is the same as the number of clamping arms 132, and the arrangement mode is the same as that of the clamping arms 132, so that the grasping arms 152 and the clamping arms 132 cooperate to achieve the clamping function.

[0073] Preferably, the grasping arms 152 are made of a shape memory material such as nitinol alloy, and an adjustment wire hole for connecting an adjustment wire (not shown in the figure) of the delivery device 200 is provided at the free end of the grasping arms 152. The free end of the grasping arms 152 can be controlled by the adjustment wire extending outside the patient's body. In the delivery state, the free end of the grasping arms 152 is tightened by the adjustment wire and abuts against the adjusting portion 120; when the clamping arms 132 are opened in the body to clamp the leaflets, the control of the free end by the adjustment wire is released to release the grasping arms 152. The grasping arms 152 return to the natural state due to their own shape memory function and press the leaflets against the clamping arms 132.

[0074] The gripping portion 150 is at least partially received in the inner surface of the clamping portion 130 in the natural state, that is, the gripping arm 152 is at least partially received in the inner surface of the clamping arm 132. In this way, after the adaptive valve clamping device 100 is closed, the outer diameter of the adaptive valve clamping device 100 in the delivery state can be reduced, which is beneficial for delivery. After the clamping arm 132 and the gripping arm 152 cooperate to grip the valve leaflet, the concave inner surface of the clamping arm 132 can increase the contact area between the clamping arm 132 and the valve leaflet, and enable the gripping arm 152 to press the valve leaflet into the inner surface of the clamping arm 132, increasing the clamping force on the valve leaflet.

[0075] Please refer to Figure 4 , the driving portion 140 includes a driving shaft 142, a connecting seat 144, and at least two link rods 146. One end of each link rod 146 is connected to a clamping arm 132, and the other end is pivotally connected to the connecting seat 144. One end of the driving shaft 142 is connected to the connecting seat 144, and the other end is movably inserted through the third seat body 116. Specifically, the number of link rods 146 is the same as the number of clamping arms 132. One end of each link rod 146 is connected to a clamping arm 132, and the other end is connected to the connecting seat 144 through a pivot shaft 148. The driving shaft 142 axially passes through the through-channel 111 of the supporting portion 110 and movably passes through the third seat body 116 to be connected to the connecting seat 144. When the driving shaft 142 axially moves relative to the third seat body 116, the link rod 146 rotates and drives the clamping arm 132 to open and close relative to the third seat body 116. When the driving shaft 142 axially moves distally relative to the third seat body 116, the link rod 146 rotates and drives the clamping arm 132 to open, and the adaptive valve clamping device 100 is in an open state; when the driving shaft 142 axially moves proximally relative to the third seat body 116, the link rod 146 rotates and drives the clamping arm 132 to close, and the adaptive valve clamping device 100 is in a closed state.

[0076] In the illustrated example, the clamping portion 130 includes two clamping arms 132, and correspondingly, two cooperating link rods 146 are provided. The distal ends of the clamping arms 132 are rotatably connected to the third seat body 116 through a connecting shaft 134 such as a pin or a bolt, etc. The distal ends of the link rods 146 are rotatably connected to the connecting seat 144 through a pivot shaft 148 such as a pin or a bolt, etc., and the proximal ends of the link rods 146 are connected to the clamping arms 132. When the driving shaft 142 axially moves distally relative to the third seat body 116, the link rod 146 rotates to drive the clamping arm 132 to rotate around the connecting shaft 134 and open relative to the third seat body 116, and the adaptive valve clamping device 100 is in an open state. When the driving shaft 142 axially moves proximally relative to the third seat body 116, the link rod 146 rotates to drive the clamping arm 132 to rotate around the connecting shaft 134 and close relative to the third seat body 116.

[0077] The shape of the connecting seat 144 is any structure such as a hemisphere, a spherical crown or a warhead shape, so that the adaptive valve clamping device 100 can be more easily pushed in the body. The drive shaft 142 and the connecting seat 144 can be an integral structure or a non-integral structure. The connecting seat 144 can be fixedly arranged at the distal end of the drive shaft 142 by means of welding or the like. To ensure safety after implantation, the drive shaft 142 and the connecting seat 144 are made of biocompatible materials such as polyester, silicone, stainless steel, cobalt alloy, cobalt-chromium alloy or titanium alloy, preferably stainless steel or cobalt-chromium alloy with higher hardness.

[0078] Furthermore, the driving part 140 further includes a locking part 141 arranged in the third seat body 116. The locking part 141 is used to lock the drive shaft 142 to limit the relative movement between the drive shaft 142 and the third seat body 116. In the conveying state, the locking part 141 restricts the relative movement between the drive shaft 142 and the third seat body 116, so as to ensure that the clamping part 130 always remains in a closed state relative to the adjusting part 120 and the supporting part 110, and avoid accidental opening of the clamping part 130. After the adaptive valve clamping device 100 reaches near the mitral valve, the restriction of the locking part 141 on the drive shaft 142 is released, and the clamping part 130 can be driven by the driving part 140 to open and clamp the valve leaf relative to the adjusting part 120 and the supporting part 110. The locking part 141 can be a combination of a steel sheet and a deformed elastic sheet in the prior art. The drive shaft 142 passes through the steel sheet and the elastic sheet. The elastic sheet abuts against the steel sheet and is inclined in the third seat body 116, so that the steel sheet is inclined and clamped on the drive shaft 142 to lock the drive shaft 142; by pulling the steel sheet to rotate, the elastic sheet elastically deforms, so that there is a gap between the connection through hole of the drive shaft 142 and the steel sheet and the elastic sheet, and the drive shaft 142 can move axially.

[0079] Please refer to Figure 4 and Figure 5 , Embodiment 1 of the present application further provides a valve clamping system. The valve clamping system includes the above-mentioned adaptive valve clamping device 100 and a conveying device 200. The conveying device 200 includes a pushing shaft 210 with a certain axial length and a mandrel (not shown in the figure) movably sleeved in the pushing shaft 210. The pushing shaft 210 is detachably connected to the supporting part 110, and the mandrel is used to drive the clamping arms 132 of the clamping part 130 to rotate around the supporting part 110. It should be known that only part of the structure of the conveying device 200 is listed here, and other parts can adopt any suitable existing structure, which will not be elaborated here.

[0080] Specifically, the mandrel is detachably connected to the driving part 140. The mandrel is used to drive the clamping arms 132 of the clamping part 130 to rotate around the supporting part 110 through the driving part 140, so as to drive the clamping part 130 to open or close. Please refer to Figure 15 and Figure 16, two card positions 1122 communicating with the lumen are symmetrically provided on the tube wall near the proximal end of the first seat body 112 of the support portion 110. A fixing member 220 is provided at the distal end of the pushing shaft 210. The fixing member 220 includes two branches, and the end of each branch is a protruding clamping platform 222. In the natural state, both branches point to the central axis of the fixing member 220. When assembling the adaptive valve clamping device 100 and the delivery device 200, the fixing member 220 at the distal end of the pushing shaft 210 is inserted into the first seat body 112 of the support portion 110, and then the core shaft is inserted into the pushing shaft 210 until the core shaft is inserted into the fixing member 220 to push the two branches of the fixing member 220 outwards, so that the clamping platforms 222 at the ends of the branches are respectively clamped into the card positions 1122, thereby connecting the support portion 110 and the pushing shaft 210, that is, connecting the adaptive valve clamping device 100 and the delivery device 200. The proximal end of the drive shaft 142 is provided with an external thread, and the core shaft is provided with an internal thread. After the core shaft is inserted into the fixing member 220, it is threadedly connected to the drive shaft 142, so that the axial movement of the drive shaft 142 can be controlled by the core shaft.

[0081] When the core shaft is disengaged from the drive shaft 142 and the core shaft is withdrawn from the fixing member 220 and the pushing shaft 210, the two branches of the fixing member 220 return to the natural state of moving inwards, and the clamping platform 222 disengages from the card position 1122 of the first seat body 112, so that the connection between the adaptive valve clamping device 100 and the delivery device 200 is released. The fixing member 220 can be made of a material with a certain hardness and elasticity such as nickel-titanium. The pushing shaft 210 can adopt a multi-layer composite tube body. The core shaft can be made of stainless steel material.

[0082] It can be understood that after the adaptive valve clamping device 100 is connected to the delivery device 200, at this time, the adaptive valve clamping device 100 is in a closed state. The adaptive valve clamping device 100 is delivered to the mitral valve of the patient through the delivery device 200. Then, the core shaft drives the drive shaft 142 to move axially towards the distal end. The drive shaft 142 drives the connecting rod 146 to rotate, and the connecting rod 146 drives the clamping arm 132 to open until the clamping arm 132 is completely opened relative to the adjusting portion 120 and the support portion 110, so that the adaptive valve clamping device 100 is in an open state. After the clamping portion 130 and the grasping portion 150 cooperate and clamp the leaflets of the valve tissue, the core shaft drives the drive shaft 142 to move axially towards the proximal end. The drive shaft 142 drives the connecting rod 146 to rotate, and the connecting rod 146 drives the clamping arm 132 to close until the clamping arm 132 is completely closed relative to the adjusting portion 120 and the support portion 110, so that the adaptive valve clamping device 100 is in a closed state and falls below the valve. After that, the connection between the core shaft and the drive shaft 142 can be released, the core shaft is withdrawn from the fixing member 220, and the clamping platform 222 is separated from the card position 1122 of the support portion 110, thereby realizing the disconnection of the adaptive valve clamping device 100 and the delivery device 200.

[0083] Since the connection point (i.e., the release point) between the adaptive valve clamping device 100 and the delivery device 200 is located within the adjustment portion 120 of the adaptive valve clamping device 100, when an opening 128 is provided at the second end 124 of the adjustment portion 120, no component will hook the catch 222 at the branched end of the fixing member 220, facilitating the release of the adaptive valve clamping device 100. Additionally, the release point being provided inside the adjustment portion 120 can reduce the axial dimension of the release point, thereby reducing the weight of the entire adaptive valve clamping device 100 and alleviating the load on the heart; the release point is not directly flushed by blood, which can avoid damage to the valve leaflets caused by repeated abrasion of the valve leaflets at the release point and also reduce the risk of thrombus formation.

[0084] Please refer to Figures 17 - 21 , taking the example of approaching and repairing the mitral valve anterogradely through the left atrium, the usage process of the adaptive valve clamping device 100 of the present application is described as follows:

[0085] The first step: As Figure 17 shown, the delivery device 200 and the adaptive valve clamping device 100 connected thereto are advanced from the left atrium LA through a guiding device such as an adjustable deflectable sheath (not shown in the figure) and passed through the mitral valve MV to reach the left ventricle LV;

[0086] The second step: Adjust the adaptive valve clamping device 100 to approach the anterior leaflet AML and posterior leaflet PML of the mitral valve MV;

[0087] The third step: As Figure 18 shown, unlock the locking member 141 in the third housing 116, push the mandrel and the drive shaft 142 distally, and the clamping arms 132 open relative to the support portion 110 and the adjustment portion 120. Adjust the direction of the clamping arms 132. At this time, the relative positions of the clamping arms 132 and the anterior leaflet AML and posterior leaflet PML of the mitral valve MV can be observed through medical imaging devices such as X-rays, so that the clamping arms 132 are perpendicular to the coaptation line of the mitral valve MV;

[0088] The fourth step: As Figure 19 shown, retract the entire adaptive valve clamping device 100 proximally, so that the clamping arms 132 support the valve leaflets on the left ventricle LV side, release the adjustment wires to release the grasping arms 152 on both sides, and each grasping arm 152 presses the valve leaflets on the atrial side and cooperates with the corresponding clamping arm 132 on that side to fix the valve leaflets, achieving complete clamping of the valve leaflets;

[0089] The fifth step: As Figure 20 shown, when the anterior leaflet AML and posterior leaflet PML of the mitral valve MV are respectively clamped between a pair of clamping arms 132 and grasping arms 152, pull the mandrel and the drive shaft 142 proximally, thereby driving the clamping arms 132 to close;

[0090] Step 6: Disconnect the threaded connection between the release mandrel and the drive shaft 142, and withdraw the mandrel backward to release the connection between the self - adaptive valve clamping device 100 and the delivery device 200. Then, withdraw the delivery device 200 out of the body to obtain the implanted state as shown in Figure 21 . At this time, the self - adaptive valve clamping device 100 pulls the anterior leaflet AML and the posterior leaflet PML of the mitral valve MV towards each other, resulting in a bicuspid mitral valve and completing the edge - to - edge repair of the mitral valve.

[0091] After the self - adaptive valve clamping device 100 is implanted, the elastic adjustment part 120 is filled between the anterior leaflet AML and the posterior leaflet PML of the clamped mitral valve MV and abuts against the clamping arm 132, thereby reducing central regurgitation and improving the treatment effect. The self - expanding body 121 (such as a reticular structure or a porous structure, etc.) of the adjustment part 120 has a buffering effect on the pulsating leaflets, so as to realize that the pulling degree of the self - adaptive valve clamping device 100 on the leaflets is adaptively adjustable to avoid damaging the leaflets. The self - expanding body 121 can be squeezed and deformed following the pulsation of the leaflets, and the generated elastic force pushes the part of the leaflet close to the self - expanding body 121 in the direction away from the support part 110, so that the clamping angle between the anterior and posterior leaflets of the mitral valve is smaller than the opening angle of the clamping arm 132, which can reduce the pulling of the clamping part 130 on the leaflets and keep the pulling degree of the self - adaptive valve clamping device 100 on the leaflets within a reasonable range all the time. In addition, when the adjustment part 120 is subjected to the pressure of the leaflets, it will produce a certain degree of deformation, and the degree of deformation increases with the increase of the pressure, so as to avoid the elastic force generated by the self - expanding body 121 acting on the clamping arm 132 after grasping the leaflets, ensuring that the grasping effect of the self - adaptive valve clamping device 100 on the leaflets after release is consistent with that before release.

[0092] Embodiment 2

[0093] Please refer to Figures 22 - 25 . The difference between the self - adaptive valve clamping device in Embodiment 2 of this application and the self - adaptive valve clamping device 100 in Embodiment 1 lies in the different structures of the first sealing head 426 of the adjustment part 420 and the second seat body 414 of the support part 410.

[0094] Specifically, the first sealing head 426 is movably sleeved outside the second seat body 414 of the support part 410. The inner cavity of the first sealing head 426 is provided with a first anti - rotation part 4260, and the outer surface of the second seat body 414 is provided with a second anti - rotation part 4140 corresponding to the first anti - rotation part 4260. The first anti - rotation part 4260 and the second anti - rotation part 4140 are detachably and cooperatively connected. In this way, by setting the detachably and cooperatively connected first anti - rotation part 4260 and second anti - rotation part 4140 to limit the axial rotation of the adjustment part 420, it is avoided that the adjustment part 420 rotates relative to the second seat body 414, so as to prevent the contact area between the adjustment part 420 and the leaflets from decreasing and affecting the leaflet clamping effect.

[0095] Please refer to Figures 22 - 24 , the first anti-rotation member 4260 includes at least one flat surface 4262 and / or at least one arc surface 4264, and the second anti-rotation member 4140 includes at least one flat surface 4142 and / or at least one arc surface 4144. In Figure 22 the example, the first anti-rotation member 4260 includes two opposite flat surfaces 4262 and two opposite arc surfaces 4264, that is, the inner cavity of the first head 426 is provided with two opposite flat surfaces 4262 and two opposite arc surfaces 4264. Correspondingly, the second anti-rotation member 4140 includes two opposite flat surfaces 4142 and two opposite arc surfaces 4144, that is, the outer surface of the second seat body 414 is provided with two opposite flat surfaces 4142 and two opposite arc surfaces 4144. During assembly, the flat surface 4262 of the first head 426 is aligned with the flat surface 4142 of the second seat body 414, and the arc surface 4264 of the first head 426 is aligned with the arc surface 4144 of the second seat body 414. In this way, when the first head 426 is sleeved outside the second seat body 414, it can ensure that the movement of the adjusting part 420 in the axial direction is not affected. At the same time, the two flat surfaces 4142 of the second seat body 414 facing the first head 426 can prevent the adjusting part 420 from rotating around the axial direction on the second seat body 414. The distance between the two flat surfaces 4262 of the first head 426 should be at least 0.01 mm larger than the distance between the two flat surfaces 4142 of the second seat body 414, preferably 0.02 - 1 mm. The distance between the two arc surfaces 4264 of the first head 426 should be at least 0.01 mm larger than the distance between the two arc surfaces 4144 of the second seat body 414, preferably 0.05 - 3 mm. In Figure 23 the example, the first anti-rotation member 4260 includes one flat surface 4262 and one arc surface 4264, and the second anti-rotation member 4140 includes two flat surfaces 4142 and one arc surface 4144. In Figure 24 the example, the second anti-rotation member 4140 includes three flat surfaces 4142 and three arc surfaces 4144. Preferably, the arc surface can be an arc surface. Of course, it can also be that the first anti-rotation member 4260 includes one arc surface 4264, and the second anti-rotation member 4140 includes multiple flat surfaces 4142, that is, the inner cavity surface of the first head 426 is a circumferential arc surface, and the cross-sectional profile of the outer surface of the second seat body 414 is a polygon.

[0096] Of course, the first anti-rotation member 4260 and the second anti-rotation member 4140 can be polyhedral structures that are cooperatively connected. For example, both the first anti-rotation member 4260 and the second anti-rotation member 4140 are triangular prism structures, that is, the inner cavity of the first head 426 is provided with three interconnected flat surfaces, and the outer surface of the second seat body 414 is correspondingly provided with three interconnected flat surfaces.

[0097] Please refer to Figure 25, one of the first rotation prevention member 4260 and the second rotation prevention member 4140 is an axially extending chute, and the other is a protrusion that cooperates with the chute. The cooperation between the chute and the protrusion restricts the axial rotation of the adjustment portion 420 while not affecting the axial movement of the adjustment portion 420. In the illustrated example, the second housing 414 is provided with an axially extending chute 4146, and the inner cavity of the first head 426 has a protrusion 4266 that protrudes inward and can move along the chute. Preferably, two opposite chutes 4146 are provided on the second housing 414, and two protrusions 4266 that protrude inward are provided on the first head 426. Of course, it is also possible that the second housing 414 is provided with an outward protrusion and the first head 426 is provided with a chute.

[0098] In other embodiments, it is also possible that the second housing 414 is provided with an outward protrusion, and the inner cavity of the first head 426 has an inward protrusion. The cooperation of the protrusion structures of the two has a guiding movement trajectory and can also prevent the adjustment portion 420 from rotating along the support portion 410.

[0099] It should be noted that in the second embodiment, the first head 426 and the first rotation prevention member 4260 are integrally formed, and the second housing 414 and the second rotation prevention member 4140 are integrally formed.

[0100] Embodiment Three

[0101] Please refer to Figure 26 and Figure 27 , compared with the adaptive valve clamping device of the second embodiment, the adaptive valve clamping device of the third embodiment of the present application is different in that the structures of the first head 526 of the adjustment portion 520 and the second housing 514 of the support portion 510 are different. In this embodiment, the first head 526 and the first rotation prevention member 5260 are detachably connected, and / or the second housing 524 and the second rotation prevention member 5140 are detachably connected. Specifically, the first head 526 and the first rotation prevention member 5260 can be fixed together by common detachable or non-detachable connection methods such as welding, bonding, screw connection, crimping, and bolt locking. The second housing 514 and the second rotation prevention member 5140 can be fixed together by common detachable or non-detachable connection methods such as welding, bonding, screw connection, crimping, and bolt locking. In this embodiment, welding connection is adopted.

[0102] Embodiment Four

[0103] Please refer to Figures 28 - 31 , compared with the adaptive valve clamping device 100 of the first embodiment, the adaptive valve clamping device 600 of the fourth embodiment of the present application is different in that the driving portion 640 further includes an unlocking control member 643 for connecting and locking the member 641. Moreover, the delivery device 200 of the valve clamping system of this embodiment further includes an operating wire 230 that is detachably connected to the unlocking control member 643.

[0104] It can be understood that the functional structure of the locking member 641 of the third seat body 616 provided on the support portion 610 is the same as that of the first embodiment, and will not be described herein again. In this embodiment, an unlocking control member 643 is provided to pull the locking member 641 to release the locking of the locking member 641 on the drive shaft 642. The unlocking control member 643 in this embodiment is a single-sided unlocking, and single-sided unlocking means that the unlocking control member 643 is connected to one side of the locking member 641. Specifically, one end of the unlocking control member 643 is connected to the locking member 641, and the unlocking control member 643 is pulled from the first end 622 to the second end 624 of the self-adjusting portion 620, so that the locking member 641 releases the locking of the drive shaft 642, and the drive shaft 642 can move axially. When the pulling force on the unlocking control member 643 is released, the locking member 641 resumes locking the drive shaft 642, so that the drive shaft 642 is relatively fixed to the third seat body 616.

[0105] To facilitate remote control of the unlocking control member 643 outside the body, the delivery device 200 further includes an operating wire 230, and the operating wire 230 is detachably connected to the unlocking control member 643. The end of the operating wire 230 extends outside the patient's body through the delivery device 200. The operating wire 230 is usually made of a polymer material. Before the self-adaptive valve clamping device 600 is released, the operating wire 230 is connected to the unlocking control member 643. When the operating wire 230 is tightened, the unlocking control member 643 releases the restriction of the locking member 641 on the drive shaft 642, and the self-adaptive valve clamping device 600 is in an unlocked state; otherwise, it is in a self-locking state.

[0106] In this embodiment, the self-expanding body 621 of the adjusting portion 620 is a hollow mesh structure with a plurality of mesh holes, and a first head 626 is provided at one end of the self-expanding body 620. One end of the unlocking control member 643 is connected to the locking member 641, and the other end axially passes through at least one mesh hole and is located in the cavity of the self-expanding body 621. The first end 622 (i.e., the end provided with the first head 626) of the adjusting portion 620 is movably sleeved outside the second seat body 614 of the support portion 610, and the second end 624 of the adjusting portion 620 is suspended, and the adjusting portion 620 can move axially relative to the support portion 610. Since the unlocking control member 643 passes through the mesh hole of the self-expanding body 621, the relative position of the unlocking control member 643 and the support portion 610 is fixed, which can prevent the first head 626 at the first end 622 of the adjusting portion 620 from rotating on the second seat body 614, and plays a limiting role in preventing the adjusting portion 620 from rotating. In this embodiment, the wearing position of the unlocking control member 643 on the self-expanding body 621 plays a role in preventing the adjusting portion 620 from rotating. The structure is simple, and there is no need to provide an anti-rotation structure for the first head 626 and the second seat body 614, which reduces the processing difficulty of the parts. In addition, when the hollow mesh structure self-expanding body 621 is welded and fixed to the first head 626, there is no need to limit the direction, which reduces the welding difficulty.

[0107] Please refer to Figure 31 , the unlocking control member 643 includes an unlocking section 6431, a first connecting section 6432 and a second connecting section 6433 connected to both ends of the unlocking section 6431. The unlocking section 6431 is lapped on the surface of the locking member 641 away from the self-expanding body 621, and the first connecting section 6432 and the second connecting section 6433 respectively extend towards the self-expanding body 621 and pass through at least one mesh hole into the cavity of the self-expanding body 62. In this way, by operating the first connecting section 6432 and the second connecting section 6433, the unlocking section 6431 pulls the locking member 641 to release the locking of the locking member 641 on the drive shaft 642. Preferably, the first connecting section 6432 and the second connecting end 6433 are symmetrically arranged in the cavity of the self-expanding body 621, and the force applied by the unlocking control member 643 to the locking member 641 during unlocking is more balanced and easy to unlock.

[0108] Specifically, the unlocking control member 643 is a double-wire structure arranged side by side. The double wires of the first connecting section 6432 and the second connecting section 6433 are both U-shaped. The double wires of the first connecting section 6432 enter the cavity of the self-expanding body 621 through the same mesh hole; the double wires of the second connecting section 6433 enter the cavity of the self-expanding body 621 through another mesh hole. In this way, when pulling the unlocking control member 643, deformation of the self-expanding body 621 is avoided. When the unlocking control member 643 is stressed, the double wires are stressed simultaneously, which can better ensure the transmission stability of the unlocking force. An unlocking control member 643 with a smaller wire diameter can be selected to meet the unlocking force requirements.

[0109] Furthermore, the adjusting portion 620 further includes a film (not shown in the figure) covering the outer surface of the self-expanding body 621. The film has an opening, and the first connecting section 6432 and the second connecting section 6433 respectively enter the cavity of the self-expanding body 621 through the opening and the mesh hole in sequence. It can be understood that the film wraps the self-expanding body 621, which can prevent the self-expanding body 621 from directly contacting the clamped valve tissue, thereby reducing or avoiding tissue allergy and inflammatory reactions and avoiding damage to the clamped valve tissue. The film can be provided with functional drugs through treatment methods such as biological modification, impregnation, brushing, drop coating or spraying. For example, anticoagulants such as heparin can be applied to the surface of the film by impregnation, spraying, etc., or the surface of the film can be biologically modified to make it have the characteristics of antithrombin. A drug coating can also be applied to the film, and the drug coating contains at least one of anticoagulant drugs, antiplatelet drugs or anti-tissue hyperplasia drugs, so as to promote endothelialization, avoid excessive tissue hyperplasia, reduce the incidence of corresponding complications and improve the postoperative survival rate.

[0110] In the valve clamping system of this embodiment, the operating wire 230 passes through at least one mesh hole of the self-expanding body 621 and enters the cavity of the self-expanding body 621, and is detachably connected to the first connecting section 6432 and the second connecting section 6433. The number of the operating wires 230 can be one. Both ends of the operating wire 230 respectively bypass the first connecting section 6432 and the second connecting section 6433. Specifically, the operating wire 230 is threaded through the U-shaped first connecting section 6432 and the second connecting section 6433, and can pull the first connecting section 6432 and the second connecting section 6433, so as to control the unlocking control member 643. Of course, the number of the operating wires 230 can be two. One operating wire 230 is connected to the first connecting section 6432, and the other operating wire 230 is connected to the second connecting section 6433. It can be understood that since the operating wire 230 passes through the mesh hole of the self-expanding body 621, the operating wire 230 not only facilitates the remote control of the unlocking control member 643 outside the body, but also further limits the rotation of the adjusting part 620. When the operating wire 230 is tightened, the limiting effect on the rotation of the adjusting part 620 is better.

[0111] It can be understood that the valve clamping system provided by this application includes any of the above-mentioned adaptive valve clamping devices and a delivery device that can deliver the adaptive valve clamping device from outside the body to near the mitral valve or tricuspid valve and clamp the valve leaflets. The above description of the valve clamping device is only for example and is not a limitation to this application. The valve clamping devices obtained by those of ordinary skill in the art based on the teachings of this application and the valve clamping systems including the valve clamping devices are all within the protection scope of this application.

[0112] It should be noted that in this article, relational terms such as "first" and "second" are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual relationship or order between these entities or operations. Moreover, the term "comprising", "including" or any other variant thereof is intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements not only includes those elements, but also includes other elements not expressly listed, or also includes elements inherent to such process, method, article or device. Without further limitation, an element defined by the statement "including a..." does not exclude the existence of another identical element in the process, method, article or device including the said element.

[0113] The above are only specific embodiments of the present application, enabling those skilled in the art to understand or implement the present application. 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 application. Therefore, the present application 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. An adaptive valve clamping device, characterized in that, Comprising: A support part, the support part including a first base body and a second base body connected to the first base body; A hollow adjusting part, the first base body being disposed within the adjusting part, the adjusting part including opposite first and second ends, and a self-expanding body located between the first and second ends, the self-expanding body being made of a shape memory material, a first end cap being provided at the first end of the adjusting part, the first end cap being movably sleeved outside the second base body and axially movable relative to the second base body, a clearance fit being provided between the inner cavity surface of the first end cap and the outer surface of the second base body, the second end of the adjusting part being suspended, the first base body being closer to the second end of the adjusting part than the second base body; and A clamping part, the clamping part including at least two clamping arms, each of the clamping arms being rotatably connected to the support part, the position where the clamping arms are rotatably connected being close to the first end of the adjusting part, the clamping arms rotating around the support part to approach or move away from the adjusting part.

2. The adaptive valve clamping device according to claim 1, wherein The range of the fit clearance between the inner cavity surface of the first end cap and the outer surface of the second base body is 0.01 - 3 millimeters.

3. The adaptive valve clamping device according to claim 2, wherein The range of the fit clearance between the inner cavity surface of the first end cap and the outer surface of the second base body is 0.05 - 1 millimeter.

4. The adaptive valve clamping device according to claim 3, wherein The range of the fit clearance between the inner cavity surface of the first end cap and the outer surface of the second base body is 0.05 - 0.2 millimeter.

5. The adaptive valve clamping device according to any one of claims 2-4, characterized in that The surface roughness range of the inner cavity surface of the first end cap is 0.1 - 2.5 micrometers, and / or the surface roughness range of the outer surface of the second base body is 0.1 - 2.5 micrometers.

6. The adaptive valve clamping device according to claim 1, wherein A first anti-rotation member is provided in the inner cavity of the first end cap, and a second anti-rotation member is provided on the outer surface of the second base body corresponding to the first anti-rotation member, the first anti-rotation member and the second anti-rotation member being detachably and cooperatively connected.

7. The adaptive valve clamping device according to claim 6, wherein, The first end cap and the first anti-rotation member are integrally formed or separately connected, and the second base body and the second anti-rotation member are integrally formed or separately connected.

8. The adaptive valve clamping device according to claim 6, wherein, The first anti-rotation member includes at least one flat surface and / or at least one arc surface, and the second anti-rotation member includes at least one flat surface and / or at least one arc surface.

9. The adaptive valve clamping device according to claim 8, wherein, The first anti-rotation member and the second anti-rotation member are a polyhedral structure in cooperative connection.

10. The adaptive valve clamping device according to claim 6, wherein, One of the first anti-rotation member and the second anti-rotation member is a chute extending axially, and the other is a protrusion cooperating with the chute.

11. The adaptive valve clamping device according to claim 1, characterized in that, The support part further includes a third base body connecting the second base body, a limiting member being provided at the end of the second base body connected to the first base body, the inner diameter of the first end cap being smaller than the outer diameter of the limiting member, and the inner diameter of the first end cap being smaller than the outer diameter of the third base body.

12. The adaptive valve clamping device according to claim 1, wherein, The support part further includes a third base body connecting the second base body, the inner diameter of the first end cap being smaller than the outer diameter of the first base body, and the inner diameter of the first end cap being smaller than the outer diameter of the third base body.

13. The adaptive valve clamping device according to claim 11 or 12, characterized in that, The at least two clamping arms are rotatably connected to the third base body, and the at least two clamping arms are circumferentially symmetrically arranged relative to the adjusting part.

14. The adaptive valve clamping device according to claim 11 or 12, characterized in that, The adaptive valve clamping device further includes a driving part, the driving part includes a driving shaft, a connecting seat and at least two connecting rods, one end of each connecting rod is connected to one of the clamping arms, and the other end is pivotally connected to the connecting seat. One end of the driving shaft is connected to the connecting seat, and the other end is movably inserted into the third seat body.

15. The adaptive valve clamping device according to claim 14, wherein, The driving part further includes a locking member disposed in the third seat body, and the locking member is used to lock the driving shaft to limit the relative movement between the driving shaft and the third seat body.

16. The adaptive valve clamping device according to claim 15, wherein, The driving part further includes an unlocking control member connected to the locking member, and the unlocking control member is used to pull the locking member to release the locking of the driving shaft by the locking member.

17. The adaptive valve clamping device according to claim 16, wherein, The self-expanding body is a hollow mesh structure with a plurality of mesh holes. One end of the unlocking control member is connected to the locking member, and the other end axially passes through at least one of the mesh holes and is located inside the cavity of the self-expanding body.

18. The adaptive valve clamping device according to claim 17, wherein, The unlocking control member includes an unlocking section, a first connecting section and a second connecting section connected to both ends of the unlocking section. The unlocking section overlaps on the surface of the locking member away from the self-expanding body. The first connecting section and the second connecting section respectively extend towards the self-expanding body and pass through at least one of the mesh holes into the cavity of the self-expanding body.

19. The adaptive valve clamping device according to claim 18, wherein, The first connecting section and the second connecting section are symmetrically arranged in the cavity of the self-expanding body.

20. The adaptive valve clamping device according to claim 18 or 19, characterized in that, The unlocking control member is a double-wire structure arranged side by side. The double wires of the first connecting section and the second connecting section are both in a U shape. The double wires of the first connecting section enter the cavity of the self-expanding body through the same mesh hole; the double wires of the second connecting section enter the cavity of the self-expanding body through another mesh hole.

21. The adaptive valve clamping device according to claim 18, wherein The adjusting part further includes a film covering the outer surface of the self-expanding body. The film has an opening, and the first connecting section and the second connecting section respectively enter the cavity of the self-expanding body through the opening and the mesh hole in sequence.

22. The adaptive valve clamping device according to claim 1, wherein The second end of the adjusting part has an opening.

23. The adaptive valve clamping device according to claim 22, characterized in that, A second end cap is further provided at the second end of the adjusting part.

24. The adaptive valve clamping device according to claim 1, wherein The adaptive valve clamping device further includes a grasping part, the grasping part is disposed between the clamping arm and the adjusting part and can be close to or away from the clamping arm. The grasping part is at least partially received in the inner surface of the clamping arm in a natural state.

25. A valve clamping system, characterized in that, An adaptive valve clamping device and a delivery device according to any one of claims 1 to 24, the delivery device includes a push shaft having a certain axial length and a mandrel movably inserted into the push shaft. The push shaft is detachably connected to the support part, and the mandrel is used to drive the clamping arm to rotate around the support part.

26. A valve clamping system, characterized in that, An adaptive valve clamping device and a delivery device according to any one of claims 18 to 21, the delivery device includes a push shaft having a certain axial length and a mandrel movably inserted into the push shaft. The push shaft is detachably connected to the support part, and the mandrel is used to drive the clamping arm to rotate around the support part; The conveying device further includes an operating wire, which passes through at least one of the mesh holes and enters the cavity of the self-expanding body, and is detachably connected to the first connecting section and the second connecting section.

27. The valve clamping system according to claim 26, characterized in that, The number of the operating wires is one, and both ends of the operating wire bypass the first connecting section and the second connecting section respectively.

28. The valve clamping system according to claim 26, wherein, The number of the operating wires is two, one of the operating wires is connected to the first connecting section, and the other operating wire is connected to the second connecting section.

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