Valve clamping device and valve clamping system with sufficient fitting

Abstract

The invention discloses a valve clamping device and a valve clamping system. The valve clamping device comprises a penetrating piece, an adjusting part and a clamping part. The adjusting part can be self-expanded and comprises a first end and a second end which are oppositely arranged, the first end of the adjusting part is arranged on the outer side of the penetrating piece in a sleeving mode and fixedly connected with the penetrating piece, and the second end of the adjusting part can move relative to the penetrating piece; and the outer diameter of the adjusting part is firstly increased and then reduced from the first end to the second end. The clamping part is arranged on the outer side of the adjusting part and can be unfolded or folded relative to the adjusting part. According to the valve clamping device, the attaching area of the valve leaflet and the adjusting part can be increased, so that the valve leaflet and the adjusting part are fully attached, and then the clamping force is improved to firmly clamp the valve leaflet.

Description

Technical Field

[0001] The present application relates to the technical field of interventional medical devices, and in particular to a fully fitting valve clamping device and a valve clamping system. Background Art

[0002] See also 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 the left ventricle 3 to the left atrium 2. The mitral valve 1 includes a pair of 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 muscle 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 aligned to prevent blood from flowing from the left ventricle 3 to the left atrium 2. Please refer to Figure 2 When organic or functional changes occur in the leaflets of the mitral valve 1 or its related structures, such as partial rupture of the chordae tendineae 4, the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1 are not properly aligned. As a result, when the left ventricle 3 of the heart contracts, the mitral valve 1 cannot be completely closed, causing blood to flow back 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 clipping refers to the treatment of mitral regurgitation by implanting a valve clipping device into the mitral valve, using a pair of closable forceps to pull the anterior and posterior leaflets toward each other, reducing or eliminating the leaflet gap. Figure 3 and Figure 4An existing valve clamping device is shown, in which an elastic net 93 is added to two clamp arms 91, and the leaflets L on each side are clamped between one clamp arm 91 and one side of the elastic net 93, respectively. The elastic net 93 is deformed to adapt to the spacing between the leaflets, thereby adjusting the pulling degree of the leaflets L by the clamp arms 91. One end 931 of the elastic net 93 is fixedly connected to the second end 951 of the penetration member 95 (the second end 951 refers to the end of the penetration member 95 close to the rotation connection portion of the two clamp arms 91) through a steel sleeve or other sealing head, and the other end 933 of the elastic net 93 is a free end that movably surrounds the penetration member 95. When the two clamp arms 91 are closed, the elastic net 93 is squeezed and deformed. Since the end cap 97 limits the axial movement of one end 931 of the elastic net 93, the elastic net 93 will stretch toward its free end 933 in the axial direction. At the same time, the two sides of the elastic net 93 squeezed by the two clamp arms 91 will retract in the radial direction. The free end 933 of the elastic net 93 and the parts near it are gradually retracted toward the central axis of the elastic net 93 under the influence of the retracted parts. This makes 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. 3 and its vicinity, the elastic fitting area between the leaflet L and the elastic net 93 is limited. Accordingly, the free end 933 of the elastic net 93 and its vicinity cannot provide radial support for the leaflet L, which may result in the clamping force of the clamp arm 91 and the elastic net 93 on the leaflet L being insufficient to firmly clamp the leaflet L, and there is a risk that the leaflet L will fall off between the clamp 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 its vicinity and the leaflet L allows the blood that flows back from the clamping gap to pass through, affecting the reflux treatment effect. Summary of the invention

[0004] In order 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.

[0005] In a first aspect, the present application provides a valve clamping device, comprising:

[0006] A self-expandable adjustment portion, the adjustment portion comprising a first end and a second end disposed oppositely;

[0007] A penetration piece, wherein the first end of the adjusting portion is sleeved on the outside of the penetration piece and fixedly connected to the penetration piece, the second end of the adjusting portion is movable relative to the penetration piece, and the outer diameter of the adjusting portion increases first and then decreases from the first end to the second end;

[0008] The clamping portion is arranged on the outer side of the adjusting portion and can be opened or closed relative to the adjusting portion.

[0009] In the second aspect, the present application provides a valve clamping system, comprising the above-mentioned valve clamping device and a conveying device, wherein the conveying device comprises: a push sheath having a certain axial length and a core shaft movably installed in the push sheath, the push sheath and the penetrating member are detachably connected, and the core shaft is used to drive the expansion and closing of the clamping part.

[0010] The valve clamping device and valve clamping system provided by the present application are characterized in that the first end of the adjusting portion is sleeved on the outside of the penetrating member and fixedly connected to the penetrating member, and the second end of the adjusting portion is movably arranged. When the clamping portion is closed relative to the adjusting portion to clamp the leaflet between the adjusting portion and the clamping portion, the axial movement of the first end of the adjusting portion and part of the self-expanding body in the vicinity thereof is restricted, and the self-expanding body will extend axially toward the second end of the adjusting portion, and at the same time, the self-expanding body will retract radially due to the squeezing of the clamping portion, and as the second end of the adjusting portion extends toward the valve edge of the leaflet, the self-expanding body gradually moves toward the second end of the adjusting portion toward the adjusting portion. The central axis of the node portion is contracted, and the partial self-expanding body near the first end of the regulating portion can fit tightly with the leaflets without any radial gap. Compared with the prior art, the fitting area between the leaflets and the regulating portion can be increased, so that the leaflets and the regulating portion are fully fitted. Accordingly, the first end of the regulating portion and the partial self-expanding body near the vicinity thereof can provide radial support for the leaflets, thereby increasing the clamping force to firmly clamp the leaflets, reducing the risk of the leaflets falling off from between the clamping portion and the regulating portion, and improving the implantation stability of the valve clamping device; at the same time, the tight fit between the partial self-expanding body near the first end of the regulating portion and the leaflets can block the blood that refluxes from the clamping gap, thereby optimizing the reflux treatment effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate some embodiments of the present invention and, together with the description, serve to explain the principles of the present invention.

[0012] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, for ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative labor.

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

[0014] Figure 2 This is a schematic diagram of a mitral valve disease.

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

[0016] Figure 4 yes Figure 3 The schematic diagram of the valve clamping device clamping the valve leaflet is shown;

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

[0018] Figure 6 yes Figure 5 A schematic diagram of the structure after the adjustment part and the insertion piece are combined;

[0019] Figure 7 yes Figure 5 A schematic diagram of the structure after the adjustment part and the fixing part are combined;

[0020] Figure 8a yes Figure 5 A schematic diagram of the three-dimensional structure of the adjusting part at a viewing angle;

[0021] Figure 8b yes Figure 5 A schematic diagram of the three-dimensional structure of the adjusting part in another viewing angle;

[0022] Fig. 9 yes Figure 5 A schematic diagram of the valve clamping device clamping the valve leaflet;

[0023] Fig.10 yes Figure 5 A schematic diagram of the structure after the clamping part and the driving part are combined;

[0024] Fig.11 yes Figure 5 A schematic diagram of the structure of the insertion member;

[0025] Fig.12 yes Figure 5 A schematic diagram of the structure of the insertion piece and the base in cooperation;

[0026] Fig.13 yes Figure 5 A schematic diagram of the structure of the cooperation between the penetration member of the middle valve clamping device and the delivery device;

[0027] Figure 14-18 Is adopted Figure 5 Schematic diagram of the process of the valve clipping device approaching the left atrium in an antegrade manner and performing edge-to-edge repair on the mitral valve;

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

[0029] Fig. 20 yes Fig.19A schematic diagram of the structure after the adjustment part and the insertion piece are combined;

[0030] Fig.21 yes Fig.19 A schematic diagram of the structure after the adjustment part and the fixing part are combined;

[0031] Fig. 22 is a schematic diagram of the valve clamping device of the third embodiment of the present application clamping the valve leaflet;

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

[0033] Fig.24 yes Fig.23 A schematic diagram of the structure after the insertion part, the driving part and the clamping part are combined;

[0034] Fig.25 yes Fig.23 A schematic diagram of the valve clamping device clamping the valve leaflet;

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

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

[0037] Fig.28 yes Fig. 27 A schematic diagram of the structure after the insertion part, the driving part and the clamping part are combined;

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

[0039] Fig.30 is a schematic structural diagram of the valve clamping device and the delivery device in the eighth embodiment of the present application;

[0040] Fig.31 yes Fig.30 Schematic diagram of a transapical approach to the mitral valve using a valve clipping device is shown. DETAILED DESCRIPTION

[0041] The technical solutions in the embodiments of the present invention will be described clearly and completely below in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

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

[0043] The directions or positional relationships indicated by the terms "upper", "lower", "inner", "outer", etc. are based on the directions or positional relationships shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a specific direction, be constructed and operate in a specific direction, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", etc. are only used for descriptive purposes and cannot be understood as indicating or implying relative importance;

[0044] When an element is referred to as being "fixed to" or "disposed on" another element, the element may 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 being "connected to" another element, it may 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 central axis of rotation 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); the radial direction refers to the direction along the diameter or radius. It is worth noting that the "end" in the terms "proximal end", "distal end", "one end", "the other end", "second end", "first end", "initial end", "end", "two ends", "free end", "upper end", "lower end", etc. is not limited to the end, endpoint or end face, but also includes a portion extending from the end, endpoint, or end face on the element to which the end, endpoint, or end face belongs for an axial distance and / or radial distance. The above definitions are only for the convenience of expression and cannot be understood as limitations on the present invention.

[0046] Embodiment 1

[0047] See also Figures 5 to 9 A first embodiment of the present invention provides a fully fitted valve clamping device 100, comprising:

[0048] The penetrating member 110 has a certain axial length and includes a second end 111 and a first end 115 that are oppositely disposed;

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

[0050] and a clamping portion 130 , which is disposed at the outer side of the adjusting portion 120 and can be opened or closed relative to the adjusting portion 120 .

[0051] The second end 121 of the adjusting portion 120 of the valve clamping device 100 is movably sleeved on the outside of the penetrating member 110, and the first end 123 of the adjusting portion 120 is sleeved on the outside of the penetrating member 110 and fixedly connected to the penetrating member 110. The second end 121 of the adjusting portion 120 is located between the second end 111 of the penetrating member 110 and the first end 123 of the adjusting portion 120, or in other words, the second end 121 of the adjusting portion 120 is closer to the second end 111 of the penetrating member 110 than the first end 123 of the adjusting portion 120.

[0052] Combination Figure 5 and Figure 14-18 The valve clamping device 100 of the first embodiment is provided with a connection portion (not shown) on the first end 115 of the penetrating member 110 that is detachably connected (such as threaded connection, snap connection, etc.) to the delivery device 200. The delivery device 200 pushes the valve clamping device 100 into the heart through a catheter, and the first end 115 of the penetrating member 110 is its proximal end, the second end 111 of the penetrating member 110 is its distal end, the first end 123 of the adjusting portion 120 is its proximal end, and the second end 121 of the adjusting portion 120 is its distal end. It can be understood that in other embodiments, the valve clamping device can be inserted into the heart through the apex, then the first end of the penetrating member is its distal end, the second end of the penetrating member is its proximal end, the first end of the adjusting portion is its distal end, and the second end of the adjusting portion is its proximal end.

[0053] Please also see Figure 5-Figure 9The valve clamping device 100 mainly includes two states, one is the expanded state and the other is the closed state. In the expanded state, the adjusting portion 120 is in a natural state without being subjected to external force, and the diameter of the self-expanding body 125 of the adjusting portion 120 in the natural state gradually increases from the second end 121 of the adjusting portion 120 to the first end 123 of the adjusting portion 120, that is, the overall shape of the adjusting portion 120 is approximately inverted cone shape, the second end 121 of the adjusting portion 120 roughly constitutes the apex of the inverted cone shape, and the portion near the first end 123 of the adjusting portion 120 constitutes the cone bottom of the inverted cone shape. In this first embodiment, one end of the clamping portion 130 is rotatably connected to the second end 111 of the penetrating member 110, so that the clamping portion 130 can expand or close around the adjusting portion 120 and with the rotational connection portion between the clamping portion 130 and the second end 111 of the penetrating member 110 as the center, and there is an axial spacing between the second end 121 of the adjusting portion 120 and the second end 111 of the penetrating member 110, so that when the adjusting portion 120 is radially squeezed, the second end 121 of the adjusting portion 120 can move axially toward the second end 111 of the penetrating member 110, then in the process of the clamping portion 130 closing around the adjusting portion 120 with the rotational connection portion between the clamping portion 130 and the second end 111 of the penetrating member 110 as the center to clamp the leaflet 1, the adjusting portion 120 is squeezed by the clamping portion 130 and undergoes radial retraction and axial extension. It can be understood that in other embodiments, one end of the clamping portion 130 can also be rotatably connected to other components, as long as the component is close to the second end 111 of the penetrating member 110, so that the clamping portion 130 is arranged on the outside of the penetrating member 110 and can be opened or closed relative to the adjustment portion 120 to clamp the leaflet.

[0054] It is worth noting that in the closed state, since the first end 123 of the adjusting portion 120 is fixedly connected to the penetrating member 110, and the second end 121 of the adjusting portion 120 is movably mounted on the penetrating member 110, the axial movement of the first end 123 of the adjusting portion 120 and the vicinity thereof of the self-expanding body 125 is restricted, and the self-expanding body 125 will extend axially toward the second end 121 of the adjusting portion 120. At the same time, the self-expanding body 125 will retract radially due to the squeezing of the clamping portion 130. As the second end 121 of the adjusting portion 120 extends toward the leaflet edge of the leaflet 1, the overall shape of the adjusting portion 120 can complement the shape of the opening of the clamping portion 130 and still present an inverted cone shape. The portion of the self-expansion body 125 near the first end 123 of the adjusting portion 120 is located at the bottom of the inverted cone, that is, it gradually converges from the expansion body 125 to the second end 121 of the adjusting portion 120 toward the central axis of the adjusting portion 120. The portion of the self-expansion body 125 near the first end 123 of the adjusting portion 120 and the leaflet 1 can fit tightly without any radial gap. Compared with the prior art, the fitting area between the leaflet 1 and the adjusting portion 120 can be increased, and the elastic fitting between the leaflet 1 and the adjusting portion 120 is improved, so that the leaflet 1 and the adjusting portion 120 are fully fitted. Accordingly, the first end 123 of the adjusting portion 120 and the self-expanding body 125 near it can provide a larger radial support 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 portion 130 and the adjusting portion 120, and improving the implantation stability of the valve clamping device 100; at the same time, the close fit between the self-expanding body 125 near the first end 123 of the adjusting portion 120 and the leaflet 1 can block the blood refluxed from the clamping gap, optimizing the reflux treatment effect. In addition, the adjusting portion 120 can adaptively adjust its own shape according to the different clamping degrees of the clamping portion 130, and can ensure that the leaflet can be fully fitted at any clamping degree.

[0055] It can be understood that, in the closed state, the second end 121 of the adjustment portion 120 can extend toward the valve edge and be closer to the valve edge position compared to the prior art, further increasing the fitting area between the leaflet 1 and the adjustment portion 120, and further improving the elastic fit between the leaflet 1 and the adjustment portion 120.

[0056] In addition, since the second end 121 of the adjusting portion 120 is movably mounted on the penetrating member 110, the adjusting portion 120 has a strong axial deformation capability, and when the valve clamping device 100 is radially compressed into the delivery sheath for in vivo delivery, it is easier to be compressed into the sheath.

[0057] For details, please refer to Figure 5 and Figure 10-13, the penetrating member 110 can be a circular tube, a square column tube or an oblate tube, etc., with both end faces axially connected. The present embodiment adopts a circular tube, and as mentioned above, the distal end of the circular tube is the second end 111, and the proximal end is the first end 115. The first end 115 of the penetrating member 110 can be surrounded and shielded by the self-expanding body 125 near the first end 123 of the regulating portion 120 in both the closed state and the unfolded state, so that the regulating portion 120 is not exposed, the first end 115 is prevented from directly contacting the leaflet, and the first end 115 is prevented from wearing the leaflet due to the long-term pulsation of the leaflet, thereby improving the implant safety.

[0058] The penetration member 110 is also provided with an axial through-hole-shaped penetration channel 113 to cooperate with the driving portion 140 and the conveying device 200. At least two clamping positions 114 are provided on the tube wall of the circular tube body of the penetration member 110, which are used to be detachably connected with the conveying device 200. For example, a clamping platform 221 is provided on the conveying device 200. After the clamping platform 221 is clamped into the clamping position 114, the conveying device 200 is clamped and connected with the penetration member 110, and the valve clamping device 100 can be conveyed. When the clamping platform 221 is separated from the clamping position 114, the conveying device 200 is separated from the valve clamping device 100. It should be known that the structure of the penetration member 110 here is only used as an example and is not a limitation of the present application. Other structures of the penetration member 110 adopted by ordinary technicians in this field based on the teachings of the present application are all within the protection scope of the present application.

[0059] See also Figure 5-Figure 9 The self-expanding body 125 of the adjusting portion 120 is a mesh structure, preferably a mesh structure made of wires woven or cut from a tube with shape memory function, such as superelastic materials such as nickel-iron alloy wire. Under the same degree of closure of the clamping portion 130, the adjusting portion 120 can adapt to the spacing between different leaflets and undergo adaptive deformation, thereby adjusting the degree of pulling of the leaflets by the valve clamping device 100. The adjusting portion 120 has a hollow accommodating cavity (not shown), and the portion of the penetrating member 110 located between the first end 115 and the second end 111 is disposed in the hollow accommodating 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 first end 123 of the adjusting portion 120 toward the first end 115 of the penetrating member 110, and the first section 124 forms a bowl-shaped concave area 122 (such as Figure 7 and Figure 8aAs shown in the figure, the first section 124 surrounds the outside of the first end 115 of the penetrating member 110, or in other words, the first end 115 of the penetrating member 110 is located in the recessed area 122. The first end 115 of the penetrating member 110 can be surrounded and shielded by the first section 124 of the self-expanded main body 125 in both the closed state and the unfolded state of the valve clamping device 100, so that the regulating portion 120 is not 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 toward the second end 111 of the penetrating member 110 and terminates at the second end 121 of the regulating portion 12. In the first embodiment, the end of the recessed area 122 (the end of the first section 124 close to the first end 123 of the regulating portion 120 is defined as the end of the recessed area 122) extends toward the second end 111 of the penetrating member 110 to the first end 123 of the regulating portion 120.

[0061] When making the adjusting part 120, first prepare a braided mesh tube with both ends open, put one end of the braided mesh tube on a lining rod, and then put a forming sleeve on the outside of one end of the braided mesh tube to form the first end 123 of the adjusting member 120; then pull the other end of the braided mesh tube outward and downward at the same time, so that the braided mesh tube is turned outward onto the forming mold; then perform heat setting treatment to form the first end 123 of the adjusting member 120. Figure 8a to Figure 8b The overall shape of the adjusting part 120 shown is approximately an inverted cone, and the other end of the braided mesh tube forms an opening second end 121 of the adjusting member 120 below one end of the braided mesh tube. The adjusting part 120 is obtained by removing the molding sleeve and the molding mold.

[0062] When the adjusting portion 120 is assembled with the penetration piece 110, the portion between the first end 115 and the second end 111 of the penetration piece 110 is inserted into the hollow accommodating cavity of the adjusting portion 120, and the first end 123 of the adjusting portion 120 is fixedly connected to the penetration piece 110 via a fixing member 80. The fixing member 80 may be a steel sleeve, and the first end 123 of the adjusting portion 120 is inserted between the steel sleeve and the outer surface of the penetration piece 110. The steel sleeve and the penetration piece 110 are then laser welded to achieve the fixed connection between the first end 123 of the adjusting portion 120 and the penetration piece 110. It is understandable that in other embodiments, the fixing member 80 may not be provided, and the first end 123 of the adjusting portion 120 may be directly fixedly connected to the penetration piece 110 by welding. In this embodiment, the first end 123 of the adjusting portion 120 is inserted into the fixing member 80 toward the second end 111 of the penetration piece 110. If the fixing member 80 is installed in the fixing member 80, the first end 123 of the adjusting portion 120 may be directly fixedly connected to the penetration piece 110 by welding. Figure 6The first end 123 of the adjusting portion 120 is located at the top, and the second end 121 of the adjusting portion 120 is located at the bottom, that is, the first end 123 of the adjusting portion 120 is inserted into the fixing member 80 from top to bottom. The diameter of the opening of the second end 121 of the adjusting portion 120 can be equal to or slightly larger than the diameter of the penetrating member 110, so that the second end 121 of the adjusting portion 120 can slide smoothly along the axial direction of the penetrating member 110. In addition, since the first end 123 of the adjusting portion 120 is fixedly connected to the penetrating member 110, and the second end 121 of the adjusting portion 120 is movably sleeved on the penetrating member 110, the center of gravity of the entire valve clamping device 100 is always located in the axial direction of the penetrating member 110, so the self-centering property is good and it is not easy to tilt.

[0063] More specifically, during the change from the expanded state to the closed state of the valve clamping device 100, the radial dimension ( Figure 6 The range of the radial dimension of the second end 121 of the adjusting portion 120 is preferably 4mm-15mm, more preferably 5mm-10mm, and the range of the radial dimension of the second end 121 of the adjusting portion 120 is 1mm-5mm, more preferably 1.2mm-3mm, so that the inverted cone shape of the adjusting portion 120 as a whole can adapt to the spacing between different leaflets after being compressed, and can have the largest possible fitting area with the leaflets.

[0064] Combination Figure 5 , Figure 6 and Fig. 9In the closed state of the valve clamping device 100, that is, when the leaflet 1 is clamped between the regulating portion 120 and the clamping portion 130, since the first end 123 of the regulating portion 120 is fixedly connected to the penetrating member 110, and the second end 121 of the regulating portion 120 is movably sleeved on the penetrating member 110, the axial movement of the first end 123 of the regulating portion 120, the first section 124 and the second section 126 of the self-expanding body 125 are restricted, and the regulating portion 120 will extend axially toward its second end 121, and at the same time, the self-expanding body 125 will retract radially due to the compression of the clamping portion 130, but the first section 124 will resist the inward deformation of the second section 126, and the second section 126 will This resistance is transmitted to the corresponding part of the third section 128 connected thereto. As the second end 121 of the regulating portion 120 extends toward the edge of the leaflet 1, the overall shape of the regulating portion 120 presents an inverted cone shape that is complementary to the shape of the opening of the clamping portion 130. The second section 126 is located at the bottom of the inverted cone. The third section 128 gradually converges toward the central axis of the regulating portion 120 from the second section 126 to the second end 121. The entire third section 128 of the self-expanding main body 125 can fit tightly with the leaflet 1 without any radial gap. The elastic fit between the leaflet 1 and the regulating portion 120 is improved, so that the leaflet 1 and the regulating portion 120 can fit fully. Accordingly, the regulating portion 120 can provide a greater radial support force for the leaflet 1, thereby increasing the clamping force to firmly clamp the leaflet 1. Fig. 9 As shown, the second section 126 of the self-expanding body 125 is not lower than the end surface of the free end of the clamping portion 130 when it is closed, so that the length of the leaflet 1 clamped between the clamping portion 130 and the regulating portion 120 is substantially the same as that of the clamping portion 130 .

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

[0066] Of course, the adjustment part 120 is not limited to being a mesh structure, but can also be other hollow structures with elasticity and self-expandability. For example, it can be a silicone body with a dense structure or a sponge body with a porous structure. The first end of the adjustment part with a dense structure or a porous structure is fixedly mounted on the penetrating member 110, and the second end is axially movably mounted on the penetrating member 110. Similarly, a similar first section, a second section and a third section can be arranged between the first end and the second end, and the leaflet and the adjustment part can also be fully fitted based on the same principle of action.

[0067] See also Figure 5 ,and Figure 9-13 The clamping portion 130 includes at least two clamp arms 131, and generally may include at least one group of clamp arms 131, and each group of clamp arms 131 includes two clamp arms 131 symmetrically arranged relative to the adjustment portion 120. The clamping portion 130 in this embodiment includes a group of clamp arms 131. It should be noted that this is only used as an example, and ordinary technicians in this field can select a suitable number of clamp arms 131 as needed, such as two or more groups of clamp arms. It is understandable that three or more clamp arms 131 can also be set in each group as needed. For example, three clamp arms 131 that can open and close relatively can be used to clamp three leaflets of the tricuspid valve at the same time, thereby treating tricuspid regurgitation; or a pair of clamp arms 131 can be used to clamp two leaflets of the tricuspid valve, which can also achieve the purpose of alleviating or treating tricuspid regurgitation.

[0068] In this embodiment, the valve clamping device 100 further includes a driving unit 140, which is connected to the clamping unit 130 to drive the clamping unit 130 to expand or close relative to the adjusting unit 120. Specifically, the driving unit 140 is respectively connected to each clamp arm 131, for example, the driving unit 140 is respectively connected to two clamp arms 131 in a group of clamp arms 131 to drive each clamp arm 131 to rotate around the adjusting unit 120, so that the clamp arm 131 is close to or away from the adjusting unit 120. In the delivery state, the driving unit 140 drives the clamp arm 131 to close around the adjusting unit 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 unit 140 drives the clamp arm 131 to clamp the valve leaflet between the clamp arm 131 and the adjusting unit 120, thereby achieving valve leaflet clamping.

[0069] In a preferred implementation of this embodiment, the valve clamping device 100 further includes a grasping portion, which may generally include at least one group of grasping arms 151, and each group of grasping arms 151 includes two grasping arms 151 symmetrically arranged relative to the adjusting portion 120. The grasping portion (e.g., grasping arm 151) is arranged between the clamping portion 130 (e.g., clamp arm 131) and the adjusting portion 120 and can be opened or closed relative to the adjusting portion 120, and the grasping portion is at least partially accommodated on the inner surface of the clamping portion 130. Of course, three or more grasping arms 151 may be arranged in each group as needed, so as to cooperate with the clamp arm 131 to realize the leaflet capturing function.

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

[0071] The valve clamping device 100 also includes a base 160 fixedly connected to the insertion member 110, and each clamp arm 131 is rotatably connected to the base 160. Specifically, the proximal end of the base 160 is fixedly connected to the second end 111 of the insertion member 110. It should be noted that this part is defined as the term "base" for the convenience of explanation. The structure that realizes the function of the base 160 can also be the second end 111 of the insertion member 110 itself, so the definition of the term "base" should not limit the scope of this application. Each clamp arm 131 in each group is rotatably connected together on the base 160 through a pivot 132, and the second end 121 of the adjustment part 120 is spaced apart from the base 160 in the axial direction. Under the drive of the drive part 140, each clamp arm 131 cooperates with each other and can be opened and closed together around the adjustment part 120.

[0072] In this embodiment, the driving part 140 includes: a driving shaft 141, a connecting seat 142 and two connecting rods 143. Among them, 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 installed in the base 160. Specifically, one end of each connecting rod 143 is rotatably connected to a clamp arm 131, and the other end is rotatably connected to the connecting seat 142 through a pivot 144, that is, each clamp 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 clamp arm 131 to expand or close with the rotating connection portion between it and the base 160 as the center.

[0073] Specifically, the driving unit 140 includes at least one set of connecting rods 143, and the configuration of the connecting rods 143 corresponds to the configuration of the clamp arms 131. Fig.10If two clamp arms 131 are used, two connecting rods 143 are correspondingly provided to work in cooperation. One end of the connecting rod 143 is rotatably connected to the connecting seat 142 by means of a pivot 144 such as a pin, and the other end is rotatably connected to the corresponding clamp arm 131 by means of a pivot such as a pin. Each clamp arm 131 is rotatably connected to the base 160 by means of a pivot 132 such as a pin. When the drive shaft 141 moves axially relative to the base 160 toward the second end 111 of the penetration member 110, the connecting rod 143 is driven to move. Under the pull of the connecting rod 143, the clamp 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 toward the first end 115 of the penetration member 110, the connecting rod 143 pushes the clamp arm 131 to rotate around the pivot 132 and closes relative to the base 160. The shape of the connection seat 142 can be any structure such as a hemisphere, a spherical crown or a bullet shape, so that the valve clamping device 100 can be pushed in the body more easily. The drive shaft 141 and the connection seat 142 can be an integral structure or a non-integrated structure. To ensure safety after implantation, the drive shaft 141 and the connection seat 142 are made of biocompatible materials such as polyester, silicone resin, stainless steel, cobalt alloy, cobalt-chromium alloy or titanium alloy, preferably stainless steel or cobalt-chromium alloy with higher hardness.

[0074] Preferably, see Fig.10 As shown, the valve clamping device 100 further includes a locking portion 170 disposed in the base 160, and the locking portion 170 limits the relative movement of the drive shaft 141 and the base 160. In the delivery state, the locking portion 170 limits the relative movement of the drive shaft 141 and the base 160, thereby ensuring that the clamping portion 130 always maintains a closed state relative to the adjustment portion 120 and the penetration member 110, thereby avoiding accidental expansion of the clamping portion 130; after reaching the vicinity of 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 drive portion 140 to expand and support the leaflet relative to the adjustment portion 120 and the penetration member 110; after clamping the leaflet, the locking portion 170 again limits the relative movement of the drive shaft 141 and the base 160, thereby maintaining the clamping state of the leaflet 1. Any existing locking portion with a suitable structure can be used, which will not be described in detail here.

[0075] Combination Figure 5 and Fig. 9 Furthermore, each end of the clamp arm 131 (the end of the clamp arm 131 away from its rotational connection portion or the free end is defined as the end of the clamp arm 131) is further provided with a flange section 137. Fig. 9From the main viewing angle, the flange section 137 is an arc surface that is turned outward toward the end of the clamp arm 131, and the radius of the arc surface is preferably 1mm-2mm. When the clamp arm 131 is closed relative to the adjustment part 120 to clamp the valve leaf 1 between the two, the valve leaf 1 and the arc flange section 137 are fitted, increasing the supporting area of ​​the valve leaf 1 at the end of the clamp arm 131, which can avoid the local force concentration of the valve leaf 1 at the end of the clamp arm 131, and effectively reduce the damage to the valve leaf caused by repeated friction between the edge of the end of the clamp arm 131 and the valve leaf 1 as the heart beats. After the clamp arm 131 is attached to the adjustment part 120, the self-expanding body 125 of the adjustment part 120 protrudes from the flange section 137 in the axial direction, or the second section 126 of the self-expanding body 125 is higher than the flange section 137, so as to ensure that the length of the valve leaf 1 clamped between the clamp arm 131 and the third section 128 of the self-expanding body 125 is not less than the length of the clamp arm 131.

[0076] See also Figure 13-Figure 17 The present invention also provides a valve clamping system, including the above-mentioned valve clamping device 100, and a conveying device 200, wherein the conveying device 200 includes: a push sheath 210 with a certain axial length and a core shaft (not shown in the figure) movably installed in the push sheath 210, the push sheath 210 and the penetration member 110 are detachably connected, and the core shaft and the driving part 140 are detachably connected to drive the expansion and closure of the clamping part 130. In this embodiment, an external thread is provided at the proximal end of the driving shaft 141, and the core shaft and the driving shaft 141 are connected by threads, so that the axial movement of the driving shaft 141 can be controlled by the core shaft outside the patient's body. It should be known that only part of the structure of the conveying device is listed here, and other parts can adopt any existing suitable structure, which will not be repeated here.

[0077] Specifically, the proximal outer wall of the penetration member 110 is symmetrically provided with at least one clamping position 114 connected to the lumen of the penetration member 110, and the distal end of the push sheath 210 is provided with a connector 220, and the connector 220 includes two branches, and the end of each branch is a raised clamping platform 221. In a natural state, both branches point to the central axis of the connector 220. During assembly, the connector 220 is inserted into the penetration member 110, and then the mandrel of the conveying device 200 is inserted into the push sheath 210 until the mandrel is inserted into the connector 220, and the two branches of the connector 220 are pushed outward, and the clamping platform 221 at the end of the branch is clamped into the two clamping positions 114 of the penetration member 110, thereby connecting the penetration member 110 with the connector 220, that is, connecting the valve clamping device 100 with the conveying device 200. When the mandrel is withdrawn from the connector 220 and the push sheath 210, the two branches return to their natural inward state, and the clamping platform 221 is disengaged from the clamping position 114 of the penetration member 110, so that the valve clamping device 100 and the delivery device 200 are disconnected. The connector 220 can be made of a material with a certain hardness and elasticity such as nickel titanium. The push sheath 210 can be made of a multi-layer composite tube. The mandrel can be made of stainless steel or nickel-titanium alloy.

[0078] Combination Fig.11 and Fig.13 The inside of the penetration member 110 is provided with a through hole as a penetration channel 113 for the drive shaft 141. The drive shaft 141 is axially slidably penetrated in the penetration channel 113 of the penetration member 110 and is fixedly connected to the connecting seat 142. After the clamping portion 130 and the grasping portion 150 cooperate and capture the valve leaflet, the drive shaft 141 is driven to move axially by the core shaft to drive the clamp arm 131 to be completely closed relative to the penetration member 110, so that the 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 141 can be released, the core shaft is withdrawn from between the connecting member 220, and the clamping platform 221 is separated from the clamping position 114 of the penetration member 110, thereby realizing the release of the valve clamping device 100 and the conveying device 200.

[0079] See also Figure 14-18 The following uses the transcatheter approach through the atrial septum-left atrium to approach and repair the mitral valve in an antegrade manner as an example to illustrate the use process of the valve clipping device 100 of the present application:

[0080] Step 1: If Fig.14 As shown, the driving shaft 141 and the valve clamping device 100 connected thereto are pushed from the left atrium 2 through the mitral valve 1 to the left ventricle 3 through a guiding device such as an adjustable curved sheath tube (not shown in the figure);

[0081] Step 2: Adjust the valve clamping device 100 to be close to the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1;

[0082] Step 3: If Fig.15 As shown, the locking portion 170 in the base 160 is unlocked, the core shaft and the driving shaft 141 are pushed distally, the forceps arm 131 is driven to open relative to the penetrating member 110, and the direction of the forceps arm 131 is adjusted. At this time, the relative position of the forceps arm 131 and the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1 can be observed by an X-ray device, so that the forceps arm 131 is perpendicular to the coaptation line of the mitral valve 1;

[0083] Step 4: If Fig.16 As shown, the entire valve clamping device 100 is withdrawn proximally, so that the forceps arm 131 holds the valve leaflet 1 on the left ventricle 3 side, and the grasping arms 151 on both sides are released. The grasping arms 151 on each side press the valve leaflet 1 on the atrium side and cooperate with the forceps arm 131 on that side to capture the valve leaflet 1;

[0084] Step 5: If Fig.17 As shown, when the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1 are captured between a pair of clamp arms 131 and the grasping arm 151, respectively, the core shaft and the driving shaft 141 are pulled proximally, thereby driving the clamp arms 131 to close;

[0085] Step 6: Release the threaded connection between the mandrel and the drive shaft 141, and withdraw the mandrel. The two branches of the connecting member 220 are restored to the state of being close to the central axis. The clamping platform 221 is separated from the clamping position 114 of the penetrating member 110. 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. Fig.18 In the implantation state shown, the valve clamping device 100 pulls the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1 toward each other to obtain a double-pore mitral valve, thereby completing the edge-to-edge repair of the mitral valve.

[0086] After the valve clamping device 100 is implanted, the elastic adjusting portion 120 is filled between the anterior leaflet 1a and the posterior leaflet 1b of the clamped mitral valve 1 and provides radial support force for the leaflet 1. The adjusting portion 120 has a buffering effect on the beating leaflet 1, thereby achieving the adjustable degree of traction of the leaflet 1 by the valve clamping device 100 to avoid damaging the leaflet 1.

[0087] Embodiment 2

[0088] See also Figures 19 to 21 Compared with the valve clamping device 100 of the first embodiment, the structures of the penetrating member 110, the clamping portion 130, the driving portion 140, the grasping portion 151, etc. of the valve clamping device 100' provided in the second embodiment of the present invention remain unchanged and will not be repeated here, but the structure of the adjusting portion 120' has changed.

[0089] Specifically, in the second embodiment, the adjusting portion 120' is provided with a bending section 129 for the self-expanding body in comparison with the adjusting portion 120 in the first embodiment, and the bending section 129 is connected between the first 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 shape that is concave toward the second end 121 of the adjusting portion 120'. The first section 124 and the bending section 129 still form a concave area 122' relative to the second section 126, and the end of the concave area 122' (the end of the bending section 129 close to the first end 123 of the adjusting portion 120' is defined as the end of the concave area 122') extends toward the first end 115 of the penetrating member 110 to the first end 123 of the adjusting portion 120'.

[0090] When making the adjusting part 120', first prepare a braided mesh tube with both ends open, put the braided mesh tube on a lining rod, and then put a forming sleeve on the upper end of the braided mesh tube to form the first end 123 of the adjusting part 120'; then upward (with Fig. 20 The first end 123 of the middle adjustment part 120' is located at the top and the second end 121 is located at the bottom. The lower end of the braided mesh tube is pushed and the braided mesh tube is heat-set by means of a forming mold to form a Fig. 20 and Fig.21 The overall shape shown is still approximately an inverted cone-shaped adjusting portion 120', and the lower end of the braided mesh tube forms an opening second end 121 of the adjusting member 120' below the upper end of the braided mesh tube. The adjusting portion 120' is obtained by removing the molding sleeve and the molding mold.

[0091] When the adjusting portion 120' is assembled with the penetration member 110, the portion between the first end 115 and the second end 111 of the penetration member 110 is inserted into the hollow accommodation cavity of the adjusting portion 120, and the first end 123 of the adjusting portion 120' is fixedly connected with the penetration member 110 through the fixing member 80, which may be a steel sleeve, and the first end 123 of the adjusting portion 120 is inserted between the steel sleeve and the outer surface of the penetration member 110, and then the steel sleeve and the penetration member 110 are laser welded to realize the fixed connection between the first end 123 of the adjusting portion 120' and the penetration member 110. In this embodiment, the first end 123 of the adjusting portion 120' is inserted into the fixing member 80 toward the first end 115 of the penetration member 110, that is, the first 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 improving the elastic fit between the leaflet and the regulating portion 120, so that the leaflet and the regulating portion 120 can be fully fitted. Accordingly, the regulating portion 120 can provide greater radial support force for the leaflet, thereby further improving the clamping force to firmly clamp the leaflet.

[0093] Embodiment 3

[0094] like Fig. 22 As shown, the valve clamping device provided in the third embodiment of the present invention is compared with the valve clamping device of the first embodiment mentioned above. The structures of the penetrating member, the clamping part, the driving part, the grasping part, etc. remain unchanged and will not be repeated here, but the structure of the self-expanding body 125' of the adjusting part has changed.

[0095] The self-expanding body 125' in the third embodiment includes, in addition to the first section 124, the second section 126 and the third section 128, an adapting section 127. The adapting section 127 is connected between the second section 126 and the third section 128, and extends radially outwards compared to the third section 128 (radially inwards toward the central axis of the penetrating member 110, and radially outwards away from the central axis of the penetrating member 110). The adapting section 127 is arranged corresponding to the flanged section 137 at the end of the clamp arm, and the shape of the side facing the flanged section 137 is complementary to the arc surface presented by the flanged section 137.

[0096] When the forceps arm is closed relative to the adjusting portion 120 to clamp the leaflets therebetween, the adapting section 127 protrudes axially from the flange section 137, or in other words, the adapting section 127 is higher than the flange section 137, and part of the leaflets are also clamped between the adapting section 127 and the flange section 137. On the one hand, the leaflets fit with the arc surface of the flange section 137, thereby increasing the supporting area of ​​the leaflets at the end of the forceps arm, thereby avoiding local force concentration on the leaflets at the end of the forceps arm, and effectively reducing the damage to the leaflets caused by repeated friction between the edge of the end of the forceps arm and the leaflets as the heart beats; on the other hand, the leaflets also fit with the arc-shaped adapting section 127, thereby further increasing the fitting area between the leaflets and the adjusting portion, and improving the elastic fitting of the leaflets and the adjusting portion, so that the leaflets and the adjusting portion fit more fully, and accordingly, the adjusting portion can provide more sufficient radial support force for the leaflets, thereby further increasing the clamping force to firmly clamp the leaflets.

[0097] Embodiment 4

[0098] See also Figure 23 to Figure 25Compared with the valve clamping device 100 of the first embodiment, the structure of the adjustment part 120 of the valve clamping device 400 provided in the fourth embodiment of the present invention remains unchanged and will not be repeated here, but the structures of the penetrating member 410, the clamping part 430 and the driving part 440 are changed.

[0099] Specifically, in the fourth embodiment, the clamping portion 430 includes at least two clamp arms, and generally may include at least one group of clamp arms, each group of clamp arms includes two clamp arms symmetrically arranged relative to the adjustment portion 120, and the clamping portion 40 in this embodiment includes a group of clamp arms. Each clamp arm is provided with at least one anchor 431, and when the clamp arm is closed relative to the adjustment portion 120, the anchor 431 can abut against the leaflet so that it is embedded in the mesh of the adjustment portion 120 of the mesh structure, so that the leaflet tissue is maintained by the anchor 431 on the basis of the adjustment portion 120 and the clamp arm clamping the leaflet.

[0100] The driving part 440 includes a driving shaft 410, an automatic closing unit 445 and at least two connecting rods 443. One end of each connecting rod 443 is rotatably connected to a corresponding clamp arm, and the other end is directly rotatably connected to the driving shaft 441 through a pin; the driving shaft 441 is movably installed in the insertion member 410; the automatic closing unit 445 connects the two clamp arms to make the clamping part 430 close to the adjusting part 120 in a natural state.

[0101] The base 416 and the second end 411 of the insertion member 410 are an integral structure, and the two clamp arms are rotatably connected to the base 416. An axial groove 419 for the pin to pass through is provided on the insertion member 410. When the driving shaft 441 drives the pin to move in the axial groove 419 toward the second end 411 of the insertion member 410, the connecting rod 443 is driven to overcome the obstruction of the automatic closing unit 445 and the two clamp arms are relatively opened.

[0102] In this embodiment, the automatic closing unit 445 is a U-shaped spring sheet, and the two ends of the U-shaped spring sheet are respectively connected to a clamp arm. When the driving shaft 441 does not apply thrust to the pin shaft, the U-shaped spring sheet uses its own reset to drive the two clamp arms 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 member such as a V-shaped spring sheet or a torsion spring.

[0103] Embodiment 5

[0104] See also Fig.26 The valve clamping device 400' provided in the fifth embodiment of the present invention is compared with the valve clamping device 400 of the fourth embodiment, in which the adjusting portion 120 in the fourth embodiment is replaced by the adjusting portion 120' in the second embodiment, and other structures remain unchanged and are not described herein.

[0105] Embodiment 6

[0106] See also Fig. 27 and Fig.28 Compared with the valve clamping device 100 of the first embodiment, the structure of the regulating part 120 of the valve clamping device 500 provided in the sixth embodiment of the present invention remains unchanged and will not be repeated here, but the structures of the clamping part 530, the driving part 540, etc. are changed.

[0107] In this embodiment, the base 516 and the second end 511 of the insertion member 510 are an integral structure, and one end of the clamp 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, the other end of the elastic driving arm 545 is connected to the other end of the clamp arm, and the other end of the driving shaft 545 is movably installed in the insertion member 510; the elastic driving arm 545 is used to make the clamping portion 530 close to the adjustment portion 120 in a natural state; one end of the grasping arm 551 is connected to the clamp arm of the clamping portion 530, and when the valve clamping device 500 is in an expanded state, the grasping arm 551 is controlled by a pull line (not shown) in the conveying device to open relative to the clamp arm to allow the valve leaf to enter between the grasping arm 551 and the clamp arm.

[0108] In this embodiment, the two clamp arms and the two elastic drive arms 545 are an integrated structure, that is, the two clamp arms themselves are also elastic. When the drive shaft 541 moves toward the second end 511 of the penetration member 510, the two clamp arms are relatively opened by overcoming the obstruction of the two elastic drive arms 545; when the drive shaft 541 does not apply a thrust to the elastic drive arms 545, the two elastic drive arms 545 use their own reset to drive the two clamp arms to close and abut against the adjustment portion 120. It is worth noting that when the drive shaft 541 continues to push toward the second end 511 of the penetration member 510, the connection between the clamp arm and the drive arm 545 can gradually approach the drive shaft 541 until the clamp arm and the drive arm 545 are basically in a straight line, and then the pull line is used to control the grasping arm 551 to abut against the adjustment portion 120. In this state, it is easier to put the entire flattened valve clamping device 500 into the sheath.

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

[0110] Embodiment 7

[0111] See also Fig.29The valve clamping device 500' provided in the seventh embodiment of the present invention is compared with the valve clamping device 500 of the sixth embodiment, in which the adjusting portion 120 in the sixth embodiment is replaced by the adjusting portion 120' in the second embodiment, and other structures remain unchanged and are not described herein.

[0112] Embodiment 8

[0113] See also Fig.30 and Fig.31 Compared with the valve clamping device 100 of the first embodiment, the valve clamping device 600 provided in the eighth embodiment of the present invention has only the structure of the penetrating member 610 changed, and other structures remain unchanged, which will not be described herein.

[0114] In this embodiment, the connection portion between the penetration member 610 and the conveying device 200' is no longer arranged at the first end as in the first embodiment, but a connection portion 670 is arranged on the base 660 at the second end of the penetration member 610, and the connection portion 670 is detachably connected to the push sheath tube of the conveying device 200'. Specifically, the connection portion 670 and the push sheath tube of the conveying device 200' are respectively provided with a splicing structure of complementary shape, and an outer sheath tube 70 is movably sleeved outside the push sheath tube. When the outer sheath tube 70 surrounds the splicing structure of complementary shape, the penetration member 610 and the conveying device 200' remain connected. When the outer sheath tube 70 is withdrawn and the splicing structure of complementary shape is exposed, the penetration member 610 and the conveying device 200' can be disconnected.

[0115] like Fig.31 As shown, the delivery device 200' of this embodiment can push the valve clamping device 600 into the heart through the apex to perform edge-to-edge repair on the mitral valve. It should be noted that before the two clamp arms are completely closed, the outer sheath 70 should remain wrapped around the complementary splicing structure; after the two clamp arms are completely closed, the threaded connection between the core shaft and the drive shaft is first released, and the core shaft is withdrawn, and then the outer sheath 70 is withdrawn to expose the splicing structure, so that the connection between the valve clamping device 600 and the delivery device 200' can be released.

[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 capable of delivering the valve clamping device from outside the body to the vicinity of the mitral valve and clamping the valve leaflets.

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

[0118] The foregoing is merely a specific embodiment of the present invention, which enables those skilled in the art to understand or implement the present invention. Various modifications to these embodiments will be apparent to those skilled in the art, and the general principles defined herein may 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 the embodiments shown herein, but rather to the widest scope consistent with the principles and novel features claimed herein.

Claims

1. A valve clamping device, characterized in that: include: A self-expandable adjustment portion, the adjustment portion comprising a first end and a second end disposed oppositely; A penetration piece, wherein the first end of the adjusting portion is sleeved on the outside of the penetration piece and fixedly connected to the penetration piece, the second end of the adjusting portion is movable relative to the penetration piece, and the outer diameter of the adjusting portion increases first and then decreases from the first end to the second end; The clamping portion is arranged on the outer side of the adjusting portion and can be opened or closed relative to the adjusting portion.

2. The valve clamping device according to claim 1, characterized in that: It also includes a fixing piece, in which the first end of the adjusting portion is inserted and fixed, so as to be fixedly connected with the insertion piece through the fixing piece.

3. The valve clamping device according to claim 1, characterized in that: The maximum radial dimension of the adjusting portion is in the range of 4 mm to 15 mm, and the first end of the adjusting portion is recessed inward from the plane where the maximum radial dimension is located.

4. The valve clamping device according to claim 1, characterized in that: The adjusting part is a mesh structure made of shape memory material, and the outside and / or inside of the mesh structure is covered with a biocompatible film.

5. The valve clamping device according to any one of claims 1 to 4, characterized in that: The valve clamping device also includes a driving portion, the clamping portion includes at least two clamp arms, the at least two clamp arms are symmetrically arranged relative to the adjustment portion, and the driving portion is respectively connected to each of the clamp arms to drive each of the clamp arms to approach or move away from the adjustment portion.

6. The valve clamping device according to claim 5, characterized in that: A flange section is provided at the end of the clamp arm, and the flange section is an arc surface turned toward the outside.

7. The valve clamping device according to claim 6, characterized in that: The adjusting portion is provided with an adapting section corresponding to the flanging section, and the shape of the adapting section facing the flanging section is complementary to the arc surface.

8. The valve clamping device according to claim 5, characterized in that: The driving part includes: a driving shaft, a connecting seat and at least two connecting rods; wherein, one end of each of the connecting rods is rotatably connected to one of the clamp arms, and the other end of each of the connecting rods 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 installed in the adjusting part.

9. The valve clamping device according to claim 5, characterized in that: The valve clamping device further comprises a gripping portion, which is disposed between the clamping portion and the regulating portion and can be opened or closed relative to the penetrating member.

10. A valve clamping system, characterized in that: It comprises the valve clamping device according to any one of claims 1 to 9, and a conveying device, wherein the conveying device comprises: a push sheath having a certain axial length and a core shaft movably installed in the push sheath, the push sheath and the penetrating member are detachably connected, and the core shaft is used to drive the expansion and closing of the clamping portion.

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