Fully fitted valve clipping devices and valve clipping systems

Abstract

The present invention discloses a valve clamping device and a valve clamping system. The valve clamping device includes a support portion, an adjustment portion and a clamping portion. The adjustment portion is self-expandable and includes a first end and a second end that are arranged opposite to each other. The first end of the adjustment portion is sleeved on the outside of the support portion and fixedly connected to the support portion. The second end of the adjustment portion is movable relative to the support portion, and the outer diameter of the adjustment portion first increases and then decreases from the first end to the second end. The clamping portion is arranged on the outside of the adjustment portion and can be expanded or closed relative to the adjustment portion. The valve clamping device can increase the fitting area between the leaflet and the adjustment portion, so that the leaflet and the adjustment portion are fully fitted, thereby increasing the clamping force to firmly clamp the 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 healthy mitral valve 1 controls blood flow from the left atrium 2 to the left ventricle 3 while preventing blood from flowing from the left ventricle 3 back to the left atrium 2. The mitral valve 1 consists of 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 muscles of the left ventricle 3 by chordae tendineae 4. Under normal circumstances, when the left ventricle 3 contracts, the edges of the anterior leaflet 1a and the posterior leaflet 1b completely close together, preventing blood from flowing from the left ventricle 3 to the left atrium 2. Figure 2 When the leaflets of the mitral valve 1 or its related structures undergo organic or functional changes, such as partial rupture of the chordae tendineae 4, the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1 are poorly 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, called "mitral valve 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 4A conventional valve clamping device 90 is shown. This device incorporates an elastic mesh 93 between two clamp arms 91. Each leaflet L is clamped between one clamp arm 91 and one side of the elastic mesh 93. The elastic mesh 93 deforms to adjust the spacing between the leaflets, thereby adjusting the degree of tension applied by the clamp arms 91 to the leaflets L. One end 931 of the elastic mesh 93 is fixedly connected to a second end 951 of a support portion 95 (the second end 951 is the end of the support portion 95 near the pivotal connection between the two clamp arms 91) via a steel sleeve or other sealing member. The other end 933 of the elastic mesh 93 is a free end that flexibly surrounds the support portion 95. When the two clamp arms 91 are closed, the elastic net 93 is squeezed and deformed. Since the head 97 restricts the axial movement of one end 931 of the elastic net 93, the elastic net 93 will 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 affected by the retracted parts and gradually retract toward the central axis of the elastic net 93. This creates 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 mesh 93 is limited. Accordingly, the free end 933 of the elastic mesh 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 mesh 93 on the leaflet L being insufficient to firmly clamp the leaflet L. There is a risk that the leaflet L will fall off between the clamp arm 91 and the elastic mesh 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 mesh 93 and its vicinity and the leaflet L allows blood refluxed 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 opposite to each other;

[0007] a support portion, wherein a first end of the adjusting portion is sleeved on an outer side of the support portion and fixedly connected to the support portion, a second end of the adjusting portion is movable relative to the support portion, and an outer diameter of the adjusting portion first increases 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, including the above-mentioned valve clamping device and a delivery device, wherein the delivery device includes: a push sheath with a certain axial length and a core shaft movably installed in the push sheath, the push sheath and the support part 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 such that the first end of the regulating portion is sleeved on the outside of the supporting portion and fixedly connected to the supporting portion, and the second end of the regulating portion is movably arranged. When the clamping portion is closed relative to the regulating portion to clamp the leaflet between the regulating portion and the clamping portion, the axial movement of the first end of the regulating portion and the part thereof near the regulating portion is restricted, and the self-expanding body will extend axially toward the second end of the regulating portion. 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 regulating portion extends toward the valve edge of the leaflet, the self-expanding body gradually moves toward the second end of the regulating portion toward the regulating portion. The central axis of the node is contracted, and the partial self-expanding body near the first end of the regulating part can fit tightly with the leaflets without any radial gap. Compared with the existing technology, the fitting area between the leaflets and the regulating part can be increased, so that the leaflets and the regulating part are fully fitted. Accordingly, the first end of the regulating part 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 part and the regulating part, 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 part 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 invention and, together with the description, serve to explain the principles of the invention.

[0012] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. 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 1 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 support part 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 adjustment part at one viewing angle;

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

[0022] Figure 9 yes Figure 5 Schematic diagram of the valve clipping device clamping the valve leaflet;

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

[0024] Figure 11 yes Figure 5 A schematic structural diagram of the support portion in FIG.

[0025] Figure 12 yes Figure 5 A schematic diagram of the structure of the support portion and the base in cooperation;

[0026] Figure 13 yes Figure 5 A schematic diagram of the structure of the support portion of the mid-valve clamping device cooperating with the delivery device;

[0027] Figures 14-18 It is adopted Figure 5 Schematic diagram of the process of antegrade approach to the left atrium and edge-to-edge repair of the mitral valve using the valve clipping device;

[0028] Figure 19 2 is a schematic structural diagram of a valve clamping device according to a second embodiment of the present application;

[0029] Figure 20 yes Figure 19A schematic diagram of the structure after the adjustment part and the support part are combined;

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

[0031] Figure 22 1 is a schematic diagram of the valve clamping device of the third embodiment of the present application clamping the valve leaflet;

[0032] Figure 23 2 is a schematic structural diagram of a valve clamping device according to a fourth embodiment of the present application;

[0033] Figure 24 yes Figure 23 A schematic diagram of the structure of the support part, the driving part and the clamping part after they are combined;

[0034] Figure 25 yes Figure 23 Schematic diagram of the valve clipping device clamping the valve leaflet;

[0035] Figure 26 1 is a schematic structural diagram of a valve clamping device according to a fifth embodiment of the present application;

[0036] Figure 27 1 is a schematic structural diagram of a valve clamping device according to a sixth embodiment of the present application;

[0037] Figure 28 yes Figure 27 A schematic diagram of the structure of the support part, the driving part and the clamping part after they are combined;

[0038] Figure 29 2 is a schematic structural diagram of a valve clamping device according to a seventh embodiment of the present application;

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

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

[0041] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only 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] Terms such as "upper," "lower," "inner," and "outer" indicate positions or relationships based on those shown in the accompanying drawings. These terms are intended solely to facilitate and simplify the description of the present invention and are not intended to indicate or imply that the devices or components referred to must have, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limiting the present invention. Furthermore, terms such as "first" and "second" are used for descriptive purposes only and should not be construed 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 objects such as cylinders and tubes is defined as the axial direction; the circumferential direction is the direction around the axis of objects such as cylinders and tubes (perpendicular to the axis and also perpendicular to the cross-sectional radius); and the radial direction refers to the direction along the diameter or radius. It is worth noting that the "end" that appears in the terms "proximal end", "distal end", "one end", "the other end", "the second end", "the first end", "the initial end", "the end", "the two ends", "the free end", "the upper end", "the lower end", etc. is not limited to the end, endpoint or end face, but also includes the part extending from the end, endpoint or end face to the component to which the end, endpoint or end face belongs for an axial distance and / or radial distance. The above definitions are only for convenience of expression and should not be understood as limitations of the present invention.

[0046] Example 1

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

[0048] The support portion 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 on 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 clipping device 100 is movably sleeved on the outside of the support portion 110, and the first end 123 of the adjusting portion 120 is sleeved on the outside of the support portion 110 and fixedly connected to the support portion 110. The second end 121 of the adjusting portion 120 is located between the second end 111 of the support portion 110 and the first end 123 of the adjusting portion 120. In other words, the second end 121 of the adjusting portion 120 is closer to the second end 111 of the support portion 110 than the first end 123 of the adjusting portion 120.

[0052] Combine Figure 5 and Figures 14-18 In the first embodiment, the valve clipping device 100 is provided with a connection portion (not shown) on the first end 115 of the support portion 110 for detachable connection (e.g., threaded connection, snap connection, etc.) to the delivery device 200. The delivery device 200 pushes the valve clipping device 100 into the heart via a catheter. The first end 115 of the support portion 110 is its proximal end, the second end 111 of the support portion 110 is its distal end, the first end 123 of the adjustment portion 120 is its proximal end, and the second end 121 of the adjustment portion is its distal end. It will be appreciated that in other embodiments, the valve clipping device may be introduced into the heart via the apical region, in which case the first end of the support portion is its distal end, the second end of the support portion is its proximal end, the first end of the adjustment portion is its distal end, and the second end of the adjustment portion is its proximal end.

[0053] Please also see Figure 5-Figure 9The valve clipping device 100 mainly has two states: an expanded state and a closed state. In the expanded state, the adjusting portion 120 is in a natural state without being subjected to external forces. 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. In other words, the overall shape of the adjusting portion 120 is approximately an inverted cone, with the second end 121 of the adjusting portion 120 roughly forming the apex of the inverted cone and the portion near the first end 123 of the adjusting portion 120 forming the base of the inverted cone. In this first embodiment, one end of the clamping portion 130 is rotatably connected to the second end 111 of the support portion 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 support portion 110 as the center. There is an axial spacing between the second end 121 of the adjusting portion 120 and the second end 111 of the support portion 110, so that when the adjusting portion 120 is subjected to radial compression, the second end 121 of the adjusting portion 120 can move axially toward the second end 111 of the support portion 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 support portion 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 support portion 110, so that the clamping portion 130 is located on the outside of the support portion 110 and can be expanded 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 supporting portion 110, and the second end 121 of the adjusting portion 120 is movably mounted on the supporting portion 110, the axial movement of the first end 123 of the adjusting portion 120 and the vicinity thereof are restricted in the self-expanding body 125, 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, and 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 open portion 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 can fit tightly with the leaflet 1 without any radial gap. Compared with the existing technology, it can increase the fitting area between the leaflet 1 and the adjusting portion 120, improve the elastic fitting between the leaflet 1 and the adjusting portion 120, and make the leaflet 1 and the adjusting portion 120 fully fit. Accordingly, the first end 123 of the adjustment portion 120 and the portion of the self-expanding body 125 adjacent thereto can provide greater radial support for the leaflets 1, thereby increasing the clamping force to securely hold the leaflets 1, reducing the risk of the leaflets 1 falling out between the clamping portion 130 and the adjustment portion 120, and improving the implant stability of the valve clamping device 100. Furthermore, the close fit between the portion of the self-expanding body 125 adjacent to the first end 123 of the adjustment portion 120 and the leaflets 1 can block blood from flowing back through the clamping gap, optimizing the reflux treatment effect. Furthermore, the adjustment portion 120 can adaptively adjust its shape based on the degree of clamping of the clamping portion 130, ensuring that it fully fits the leaflets at any clamping level.

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

[0056] In addition, since the second end 121 of the adjusting portion 120 is movably mounted on the supporting portion 110 , the adjusting portion 120 has a strong axial deformation capability. 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 10-13The support portion 110 may be a circular tube, a square cylindrical tube, or an oblate tube, etc., with both end faces axially connected. This embodiment adopts a circular tube. 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 support portion 110 can be surrounded and shielded by the self-expanding body 125 near the first end 123 of the adjustment portion 120 in both the closed state and the expanded state, so that the adjustment 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 safety of implantation.

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

[0059] See also Figure 5-Figure 9 The self-expanding body 125 of the adjustment portion 120 is a mesh structure, preferably a mesh structure woven from wire or cut from tubular material with shape memory properties, such as a superelastic material such as nickel-iron alloy wire. Under the same degree of closure of the clamping portion 130, the adjustment portion 120 can adaptively deform to adapt to the spacing between different leaflets, thereby adjusting the degree of traction applied to the leaflets by the valve clamping device 100. The adjustment portion 120 has a hollow housing (not shown), and the portion of the support portion 110 located between the first end 115 and the second end 111 is disposed within this hollow housing.

[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 adjustment portion 120 toward the first end 115 of the support portion 110, and the first section 124 forms a bowl-shaped concave area 122 (such as Figure 7 and Figure 8a), the first section 124 surrounds the outside of the first end 115 of the support portion 110, or in other words, the first end 115 of the support portion 110 is located within the recessed area 122. The first end 115 of the support portion 110 can be surrounded and shielded by the first section 124 of the self-expandable body 125 in both the closed and expanded states of the valve clipping device 100, thereby preventing the adjustment portion 120 from being 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 support portion 110 and terminates at the second end 121 of the adjustment portion 120. In this first embodiment, the end of the recessed area 122 (the end of the first section 124 closest to the first end 123 of the adjustment portion 120 is defined as the end of the recessed area 122) extends toward the second end 111 of the support portion 110 to the first end 123 of the adjustment portion 120.

[0061] When making the adjusting portion 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 following Figures 8a to 8b The overall shape of the adjustment part 120 shown is approximately an inverted cone, and the other end of the braided mesh tube forms the second end 121 of the adjustment part 120 with an opening below one end of the braided mesh tube. The adjustment part 120 is obtained by removing the molding sleeve and the molding mold.

[0062] When the adjusting portion 120 is assembled with the supporting portion 110, the portion between the first end 115 and the second end 111 of the supporting portion 110 is passed through the hollow accommodating cavity of the adjusting portion 120, and the first end 123 of the adjusting portion 120 is fixedly connected to the supporting portion 110 through the fixing member 80. The fixing member 80 may be a steel sleeve. The first end 123 of the adjusting portion 120 is passed between the steel sleeve and the outer surface of the supporting portion 110, and then the steel sleeve and the supporting portion 110 are laser welded to achieve the fixed connection between the first end 123 of the adjusting portion 120 and the supporting portion 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 supporting portion 110 by welding. In this embodiment, the first end 123 of the adjusting portion 120 is passed through the fixing member 80 toward the second end 111 of the supporting portion 110. If the fixing member 80 is inserted into the fixing member 80, the first end 123 of the adjusting portion 120 may be fixedly connected to the supporting portion 110. Figure 6The first end 123 of the adjusting portion 120 is positioned upward, and the second end 121 of the adjusting portion 120 is positioned downward, meaning that 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 support portion 110, allowing it to be flexibly mounted on the support portion 110, thereby enabling the second end 121 of the adjusting portion 120 to slide smoothly along the axial direction of the support portion 110. Furthermore, because the first end 123 of the adjusting portion 120 is fixedly connected to the support portion 110, while the second end 121 of the adjusting portion 120 is flexibly mounted on the support portion 110, the center of gravity of the entire valve clipping device 100 is always located axially of the support portion 110, resulting in good self-centering and resistance to tilting.

[0063] More specifically, during the change from the expanded state to the closed state of the valve clipping device 100, the radial dimension ( Figure 6 The range of the second end 121 of the adjusting portion 120 is preferably 4mm-15mm, more preferably 5mm-10mm, and the radial dimension of the second end 121 of the adjusting portion 120 is in the range of 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 distance between different leaflets after being compressed, and can have the largest possible fitting area with the leaflets.

[0064] Combine Figure 5 、 Figure 6 and Figure 9, when the valve clamping device 100 is in the closed state, 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 supporting portion 110, and the second end 121 of the regulating portion 120 is movably sleeved on the supporting portion 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 squeezing 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, and 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, and 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, and 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. As Figure 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 basically the same as that of the clamping portion 130.

[0065] It is understood that in other embodiments, the exterior and / or interior of the mesh-structured adjustment portion 120 may be covered with a biocompatible film. This film can serve as a flow barrier to block blood reflux from the clamping gap, improving the reflux treatment effect and preventing blood from entering the adjustment portion 120 and forming thrombi. Furthermore, this film can enhance the biocompatibility of the valve clamping device 100. The film can be made of, but is not limited to, biocompatible polymers such as PTFE, EPTFE, polyester, and silicone.

[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 support part 110, and the second end is axially movably mounted on the support part 110. Similarly, a similar first section, second section and 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 Figures 9-13 The clamping portion 130 includes at least two clamp arms 131, and generally can include at least one group of clamp arms 131, each group of clamp arms 131 including two clamp arms 131 symmetrically arranged relative to the adjustment portion 120. In this embodiment, the clamping portion 130 includes a group of clamp arms 131. It should be noted that this is only used as an example, and a person skilled in the art 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 provided in each group as needed. For example, three relatively openable clamp arms 131 can be used to simultaneously clamp the three leaflets of the tricuspid valve, thereby treating tricuspid regurgitation; or a pair of clamp arms 131 can be used to clamp two leaflets of the tricuspid valve, thereby achieving 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 portion 130 to drive the clamping portion 130 to expand or close relative to the adjustment portion 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 adjustment portion 120, thereby causing the clamp arms 131 to move closer to or further away from the adjustment portion 120. In the delivery state, the driving unit 140 drives the clamp arms 131 to close around the adjustment portion 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 arms 131 to clamp the valve leaflets between the clamp arms 131 and the adjustment portion 120, thereby clamping the valve leaflets.

[0069] In a preferred embodiment of this embodiment, the valve clipping device 100 further includes a grasping portion, which generally may include at least one set of grasping arms 151. Each set of grasping arms 151 includes two grasping arms 151 symmetrically arranged relative to the adjustment portion 120. The grasping portion (e.g., the grasping arms 151) is disposed between the clamping portion 130 (e.g., the clamping arms 131) and the adjustment portion 120 and can be expanded or closed relative to the adjustment portion 120. 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 provided in each set as needed, thereby cooperating with the clamping arms 131 to achieve the leaflet capture function.

[0070] In the delivery state, the grasping portion is at least partially contained within the inner surface of the clamping portion 130, that is, the grasping arm 151 is at least partially contained within the inner surface of the clamp arm 131, thereby reducing the outer diameter of the valve clamping device 100 and facilitating delivery. After the clamp arm 131 and the grasping arm 151 cooperate to capture the valve leaflet, the grasping arm 151 presses the leaflet into the inner surface of the clamp arm 131, thereby increasing the contact area between the clamp arm 131 and the leaflet and enhancing the clamping force on the leaflet.

[0071] The valve clamping device 100 also includes a base 160 fixedly connected to the support portion 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 support portion 110. It should be noted that for ease of explanation, this portion is defined as the "base." The structure that implements the function of the base 160 may also be the second end 111 of the support portion 110 itself. Therefore, the definition of the term "base" should not limit the scope of this application. Each clamp arm 131 in each group is rotatably connected to the base 160 via a pivot 132. The second end 121 of the adjustment portion 120 is axially spaced apart from the base 160. Under the drive of the drive unit 140, each clamp arm 131 cooperates with each other to expand and close around the adjustment portion 120.

[0072] In this embodiment, the drive unit 140 includes a drive shaft 141, a connecting base 142, and two connecting rods 143. Each connecting rod 143 has one end rotatably connected to the clamping portion 130 and the other end rotatably connected to the connecting base 142. The drive shaft 141 has one end fixedly connected to the connecting base 142 and the other end movably mounted within the base 160. Specifically, each connecting rod 143 has one end rotatably connected to a clamp arm 131 and the other end rotatably connected to the connecting base 142 via a pivot 144. That is, each clamp arm 131 is rotatably connected to the connecting base 142 of the drive shaft 141 via the corresponding connecting rod 143. The drive shaft 141 movably passes through the base 160. When the drive shaft 141 slides axially relative to the base 160, it drives the connecting rod 143 to rotate, causing the clamp arm 131 to expand or close about its rotatably connected portion with the base 160.

[0073] Specifically, the driving portion 140 includes at least one set of connecting rods 143, and the arrangement of the connecting rods 143 corresponds to the arrangement of the clamp arms 131. For example, Figure 10In the embodiment, two clamp arms 131 are used, and correspondingly, two connecting rods 143 are provided for cooperation. One end of the connecting rod 143 is rotatably connected to the connecting base 142 via a pivot 144, such as a pin, and the other end is rotatably connected to the corresponding clamp arm 131 via a pivot 132, such as a pin. Each clamp arm 131 is rotatably connected to the base 160 via 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 support portion 110, it drives the connecting rod 143 to move. Under the pull of the connecting rod 143, the clamp arm 131 rotates about 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 support portion 110, the connecting rod 143 forces the clamp arm 131 to rotate about the pivot 132 and close relative to the base 160. The connector 142 can be shaped like a hemisphere, a spherical cap, or a bullet, making it easier to push the valve clamping device 100 inside the body. The drive shaft 141 and connector 142 can be integral or non-integrated. To ensure safety after implantation, the drive shaft 141 and connector 142 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, which have a higher hardness.

[0074] Preferably, see Figure 10 As shown, the valve clamping device 100 further includes a locking portion 170 disposed within the base 160. The locking portion 170 restricts relative movement between the drive shaft 141 and the base 160. During delivery, the locking portion 170 restricts relative movement between the drive shaft 141 and the base 160, thereby ensuring that the clamping portion 130 remains closed relative to the adjustment portion 120 and the support portion 110, preventing accidental deployment of the clamping portion 130. Upon reaching the vicinity of the mitral valve, the locking portion 170 releases the restriction on the drive shaft 141, allowing the drive portion 140 to drive the clamping portion 130 to deploy relative to the adjustment portion 120 and the support portion 110 and support the leaflets. After clamping the leaflets, the locking portion 170 again restricts relative movement between the drive shaft 141 and the base 160, thereby maintaining the clamped state of the leaflets 1. Any suitable existing locking portion structure may be employed, and further description is omitted here.

[0075] Combine Figure 5 and Figure 9 Furthermore, the end of each clamp arm 131 (the end of the clamp arm 131 away from its rotation connection part or the free end is defined as the end of the clamp arm 131) is further provided with a flange section 137. Figure 9From a frontal perspective, the flange section 137 is an arcuate surface that is tilted outward toward the end of the clamp arm 131, with a radius of preferably 1mm-2mm. When the clamp arm 131 is closed relative to the adjustment portion 120 to clamp the valve leaflet 1 therebetween, the valve leaflet 1 and the arcuate flange section 137 form a fit, increasing the support area of ​​the valve leaflet 1 at the end of the clamp arm 131. This prevents localized force concentration on the valve leaflet 1 at the end of the clamp arm 131 and effectively reduces damage to the valve leaflet caused by repeated friction between the edge of the clamp arm 131 and the valve leaflet 1 as the heart beats. After the clamp arm 131 is abutted against the adjustment portion 120, the self-expanding body 125 of the adjustment portion 120 protrudes axially beyond the flange section 137, or in other words, the second section 126 of the self-expanding body 125 is higher than the flange section 137, ensuring that the length of the valve leaflet 1 clamped between the clamp arm 131 and the third section 128 of the self-expanding body 125 is no less than the length of the clamp arm 131.

[0076] See Figure 13-17 The present invention also provides a valve clamping system, comprising the above-mentioned valve clamping device 100, and a delivery device 200, wherein the delivery device 200 comprises: a push sheath 210 having 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 support portion 110 are detachably connected, and the core shaft and the driving portion 140 are detachably connected to drive the expansion and closure of the clamping portion 130. In this embodiment, an external thread is provided at the proximal end of the drive shaft 141, and the core shaft and the drive shaft 141 are connected by a thread, so that the axial movement of the drive shaft 141 can be controlled by the core shaft outside the patient's body. It should be noted that what is listed here is only a partial structure of the delivery device, and the other parts can adopt any existing suitable structure, which will not be repeated here.

[0077] Specifically, the proximal outer wall of the support portion 110 is symmetrically provided with at least one latching position 114 that is connected to the lumen of the support portion 110. A connector 220 is provided at the distal end of the push sheath 210. The connector 220 includes two branches, each of which ends in a raised latching platform 221. In a natural state, both branches point toward the central axis of the connector 220. During assembly, the connector 220 is inserted into the support portion 110, and the core shaft of the delivery device 200 is then inserted into the push sheath 210 until the core shaft is inserted into the connector 220. The two branches of the connector 220 are then pushed outward, and the latching platforms 221 at the ends of the branches are latched into the two latching positions 114 of the support portion 110, thereby connecting the support portion 110 to the connector 220, that is, connecting the valve clamping device 100 to the delivery device 200. When the core shaft is withdrawn from the connector 220 and the push sheath 210, the two branches return to their natural inward position, and the latch 221 disengages from the latch 114 of the support portion 110, disconnecting the valve clipping device 100 from the delivery device 200. The connector 220 can be made of a material with a certain degree of hardness and elasticity, such as nickel titanium. The push sheath 210 can be a multi-layer composite tube. The core shaft can be made of stainless steel or a nickel titanium alloy.

[0078] Combine Figure 11 and Figure 13 The support portion 110 has a through hole inside that serves as a passage 113 for the drive shaft 141. The drive shaft 141 slides axially through the passage 113 of the support portion 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 core shaft drives the drive shaft 141 to move axially, thereby driving the clamp arm 131 to completely close relative to the support portion 110, so that the valve clamping device 100 is in a closed state and falls below the valve. The connection between the core shaft and the drive shaft 141 can then be released, the core shaft withdraws from between the connectors 220, and the clamping platform 221 separates from the clamping position 114 of the support portion 110, thereby achieving the release of the valve clamping device 100 and the delivery device 200.

[0079] See Figures 14-18 The following uses the transcatheter approach through the atrial septum and 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 Figure 14 As shown, the drive shaft 141 and the valve clamping device 100 connected thereto are advanced from the left atrium 2 through the mitral valve 1 to the left ventricle 3 via an adjustable sheath or other guiding device (not shown).

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

[0082] Step 3: If Figure 15 As shown, the locking portion 170 in the base 160 is unlocked, the core shaft and the drive shaft 141 are pushed distally, the forceps arm 131 is driven to open relative to the support portion 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 X-ray equipment, so that the forceps arm 131 is perpendicular to the coaptation line of the mitral valve 1;

[0083] Step 4: If Figure 16 As shown, the entire valve clipping 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 atrial side and cooperate with the forceps arm 131 on that side to capture the valve leaflet 1;

[0084] Step 5: If Figure 17 As shown, when the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1 are respectively captured between a pair of clamp arms 131 and the grasping arm 151, 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 core shaft and the drive shaft 141, and withdraw the core shaft. 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 support part 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, and the valve is obtained. Figure 18 In the implanted state shown, the valve clipping device 100 pulls the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1 toward each other, obtaining a double-pore mitral valve and 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 for the leaflet 1. The adjusting portion 120 has a buffering effect on the beating leaflet 1, thereby enabling the valve clamping device 100 to adjust the degree of traction on the leaflet 1 to avoid damaging the leaflet 1.

[0087] Example 2

[0088] See also Figures 19 to 21 Compared with the valve clamping device 100 of the first embodiment, the valve clamping device 100' provided in the second embodiment of the present invention has the same structures as the support part 110, the clamping part 130, the driving part 140, the grasping part 151, etc., which will not be described here, but the structure of the adjustment part 120' has changed.

[0089] Specifically, in this second embodiment, the adjustment portion 120' has a further bent section 129, compared to the adjustment portion 120 in the first embodiment, in the self-expanding body. The bent section 129 connects between the first end 123 of the adjustment portion 120' and the first section 124 of the self-expanding body. Preferably, the cross-section of the bent section 129 is an arcuate shape that is concave toward the second end 121 of the adjustment portion 120'. The first section 124 and the bent section 129 still form a recessed area 122' relative to the second section 126. The end of the recessed area 122' (the end of the bent section 129 closest to the first end 123 of the adjustment portion 120' is defined as the end of the recessed area 122') extends toward the first end 115 of the support portion 110 to the first end 123 of the adjustment portion 120'.

[0090] When making the adjustment 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 adjustment member 120'; then upward (with Figure 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 the following Figure 20 and Figure 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 the second end 121 of the adjusting member 120' with an opening below the upper end of the braided mesh tube. The adjusting portion 120' is obtained by removing the forming sleeve and the forming mold.

[0091] When the adjusting portion 120' is assembled with the supporting portion 110, the portion between the first end 115 and the second end 111 of the supporting portion 110 is inserted into the hollow accommodating cavity of the adjusting portion 120. The first end 123 of the adjusting portion 120' is fixedly connected to the supporting portion 110 via a fixing member 80. The fixing member 80 may be a steel sleeve. The first end 123 of the adjusting portion 120 is inserted between the steel sleeve and the outer surface of the supporting portion 110. The steel sleeve is then laser welded to the supporting portion 110 to achieve the fixed connection between the first end 123 of the adjusting portion 120' and the supporting portion 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 supporting portion 110, that is, the first end 123 of the adjusting portion 120' is inserted into the fixing member 80 from the bottom up.

[0092] When the valve clipping device 100' is closed, the bent section 129 resists the inward deformation of the first section 124. This resistance is transmitted to the corresponding portion of the third section 128 connected to the second section 126, further enhancing the elastic fit between the leaflets and the regulating portion 120, ensuring a full fit between the leaflets and the regulating portion 120. Consequently, the regulating portion 120 can provide greater radial support for the leaflets, further increasing the clamping force to securely hold the leaflets.

[0093] Example 3

[0094] like Figure 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 support part, clamping part, driving part, grasping part, etc. remain unchanged and will not be repeated here, but the structure of the self-expanding body 125' of the adjustment part has changed.

[0095] In addition to the first section 124, the second section 126, and the third section 128, the self-expanding body 125' of this third embodiment also includes an adaptor section 127. The adaptor section 127 connects between the second section 126 and the third section 128 and extends radially outward relative to the third section 128 (radially inward toward the central axis of the support portion 110 and radially outward away from the central axis of the support portion 110). The adaptor section 127 is positioned to correspond to the flange section 137 at the end of the caliper arm, and the shape of the side facing the flange section 137 complements the curved surface of the flange section 137.

[0096] When the forceps arm is closed relative to the adjusting portion 120 to clamp the leaflet 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 leaflet is also clamped between the adapting section 127 and the flange section 137. On the one hand, the leaflet fits with the arc surface of the flange section 137, thereby increasing the supporting area of ​​the leaflet at the end of the forceps arm, which can avoid local force concentration on the leaflet at the end of the forceps arm, and effectively reduce the damage to the leaflet caused by repeated friction between the edge of the end of the forceps arm and the leaflet as the heart beats; on the other hand, the leaflet also fits with the arc-shaped adapting section 127, further increasing the fitting area between the leaflet and the adjusting portion, and improving the elastic fitting of the leaflet and the adjusting portion, so that the leaflet and the adjusting portion fit more fully. Accordingly, the adjusting portion can provide more sufficient radial support force for the leaflet, thereby further increasing the clamping force to firmly clamp the leaflet.

[0097] Example 4

[0098] See also Figures 23 to 25Compared with the valve clamping device 100 of the first embodiment, the valve clamping device 400 provided in the fourth embodiment of the present invention has the same structure as the adjustment portion 120 and will not be described here, but the structures of the support portion 410, the clamping portion 430, and the driving portion 440 have changed.

[0099] Specifically, in this fourth embodiment, the clamping portion 430 includes at least two arms, and generally can include at least one set of arms. Each set of arms includes two arms symmetrically arranged relative to the adjustment portion 120. The clamping portion 40 in this embodiment includes a set of arms. Each arm is provided with at least one anchor 431. When the arms are closed relative to the adjustment portion 120, the anchors 431 can abut against the leaflets, embedding them within the mesh of the mesh-like adjustment portion 120. This allows the anchors 431 to maintain the leaflet tissue while the adjustment portion 120 and the arms clamp the leaflets.

[0100] The drive unit 440 includes a drive shaft 410, an automatic closing unit 445, and at least two connecting rods 443. Each connecting rod 443 has one end pivotally connected to a corresponding clamp arm and the other end pivotally connected to a drive shaft 441 via a pin. The drive shaft 441 is movably mounted within the support unit 410. The automatic closing unit 445 connects the two clamp arms, ensuring that the clamping portion 430 rests against the adjustment portion 120 in its natural state.

[0101] The base 416 and the second end 411 of the support portion 410 are integrally structured, and the two pliers arms are rotatably connected to the base 416. An axial slot 419 is defined in the support portion 410, through which the pin passes. When the drive shaft 441 drives the pin within the axial slot 419 toward the second end 411 of the support portion 410, it drives the connecting rod 443 to overcome the obstruction of the automatic closing unit 445, allowing the two pliers arms to open relative to each other.

[0102] In this embodiment, the automatic closing unit 445 is a U-shaped spring clip, with each end of the U-shaped spring clip connected to a clamp arm. When the drive shaft 441 does not apply thrust to the pin, the U-shaped spring clip resets itself, driving the two clamp arms toward closing and abutting against the adjustment portion 120. It is understood that in other embodiments, the automatic closing unit 445 can also be a V-shaped spring clip or an elastic member such as a torsion spring.

[0103] Example 5

[0104] See also Figure 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. The adjusting portion 120 in the fourth embodiment is replaced by the adjusting portion 120' in the second embodiment. Other structures remain unchanged and are not described here.

[0105] Example 6

[0106] See also Figure 27 and Figure 28 Compared with the valve clamping device 100 of the first embodiment, the valve clamping device 500 provided in the sixth embodiment of the present invention has the same structure of the adjustment part 120, which will not be described here, but the structures of the clamping part 530, the driving part 540, etc. have changed.

[0107] In this embodiment, the base 516 and the second end 511 of the support portion 510 are integrally structured, 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, and the other end of the elastic driving arm 545 is connected to the other end of the clamp arm. The other end of the driving shaft 545 is movably mounted in the support portion 510. The elastic driving arm 545 is used to keep the clamping portion 530 in a natural position against the adjustment portion 120. One end of the grasping arm 551 is connected to the clamp arm of the clamping portion 530. When the valve clamping device 500 is deployed, the grasping arm 551 is controlled by a pull wire (not shown) within the delivery device to open relative to the clamp arm, allowing the valve leaflet 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 integrally structured, meaning the two clamp arms themselves are also elastic. When the drive shaft 541 moves toward the second end 511 of the support portion 510, the two clamp arms are able to open relative to each other, overcoming the resistance of the two elastic drive arms 545. When the drive shaft 541 does not apply a force to the elastic drive arms 545, the two elastic drive arms 545 self-reset and drive the two clamp arms toward closing, abutting the adjustment portion 120. It is noteworthy that as the drive shaft 541 continues to push toward the second end 511 of the support portion 510, the connection between the clamp arms and the drive arms 545 gradually moves toward the drive shaft 541 until the clamp arms and the drive arms 545 are substantially aligned. The pull wire is then used to control the gripping arms 551 to abut the adjustment portion 120. In this state, the entire, flattened valve clamping device 500 is more easily accommodated within the sheath.

[0109] In addition, the valve clamping device 500 of this embodiment can achieve 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 separating from the leaflet, thereby preventing the leaflet from being damaged by excessive pulling force.

[0110] Example 7

[0111] See also Figure 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 mentioned above. The adjustment portion 120 in the sixth embodiment is replaced by the adjustment portion 120' in the second embodiment. Other structures remain unchanged and are not described here.

[0112] Example 8

[0113] See also Figure 30 and Figure 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 support portion 610 changed, and other structures remain unchanged, which will not be repeated here.

[0114] In this embodiment, the connection between the support portion 610 and the delivery device 200' is no longer located at the first end as in the first embodiment. Instead, a connection portion 670 is provided on the base 660 at the second end of the support portion 610. The connection portion 670 is detachably connected to the delivery sheath of the delivery device 200'. Specifically, the connection portion 670 and the delivery sheath of the delivery device 200' are each provided with a complementary splicing structure. An outer sheath 70 is movably mounted outside the delivery sheath. When the outer sheath 70 surrounds the complementary splicing structure, the support portion 610 and the delivery device 200' remain connected. When the outer sheath 70 is withdrawn and the complementary splicing structure is exposed, the support portion 610 and the delivery device 200' can be disconnected.

[0115] like Figure 31 As shown, the delivery device 200' of this embodiment can be used to deliver the valve clipping device 600 into the heart via a transapical approach to perform edge-to-edge repair of 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, the core shaft is withdrawn, and then the outer sheath 70 is withdrawn to expose the splicing structure, thereby releasing the connection between the valve clipping device 600 and the delivery device 200'.

[0116] It can be understood that the valve clamping system provided by the present invention includes any of the above-mentioned valve clamping devices and a delivery device 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 interventional 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 description is intended only to provide specific embodiments of the present invention, intended to enable those skilled in the art to understand and implement the present invention. Various modifications to these embodiments will be readily 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 is not intended to be limited to the embodiments shown herein, but is intended to be accorded 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 opposite to each other; a support portion, wherein the first end of the adjusting portion is sleeved on the outside of the supporting portion and fixedly connected to the supporting portion, the second end of the adjusting portion is movably sleeved on the outside of the supporting portion, the outer diameter of the adjusting portion in a natural state gradually increases from the second end to the first end, and the overall shape of the adjusting portion is approximately an inverted cone; 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 clipping device according to claim 1, characterized in that: It also includes a fixing piece, in which the first end of the adjusting portion is passed through and fixed to be fixedly connected to the supporting portion through the fixing piece.

3. The valve clipping 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 clipping device according to claim 1, characterized in that: The adjusting portion 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 clipping 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, and the at least two clamp arms are symmetrically arranged relative to the adjustment portion. 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 clipping device according to claim 5, characterized in that: The end of the clamp arm is provided with a flange section, and the flange section is an arc surface turned toward the outside.

7. The valve clipping 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 clipping 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 connecting rod is rotatably connected to one of the clamp arms, and the other end of each connecting rod is rotatably connected to the connecting seat; one end of the driving shaft is connected to the connecting seat, and the other end of the driving shaft is movably installed in the adjusting part.

9. The valve clipping device according to claim 5, characterized in that: The valve clamping device further includes a gripping portion, which is disposed between the clamping portion and the adjusting portion and can be expanded or closed relative to the supporting portion.

10. A valve clipping 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 support part are detachably connected, and the core shaft is used to drive the expansion and closure of the clamping part.

Images