Stable coaptation valve clip device and valve clipping system

Abstract

The application discloses a stable fitting valve clamping device and a valve clamping system. The stable fitting valve clamping device comprises a support, an adjusting part sleeved on the support and a clamping part rotationally connected to the support. The adjusting part is configured to have a three-dimensional structure with elasticity, and comprises a first closed end, a second closed end, an outer layer, an inner layer arranged between the outer layer and the support and a turnover layer. The first closed end and the second closed end are both sleeved on the outer side of the support. The turnover layer is transitionally connected to one end of the inner layer and the outer layer. The other end of the inner layer is connected to at least one of the first closed end and the second closed end. The first closed end and the second closed end are fixedly arranged relative to the support; or the first closed end and the second closed end are fixed in position and can move a small range relative to the support along the axial direction of the support. The valve clamping system comprises a conveying device and the stable fitting valve clamping device.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a valve clamping device and valve clamping system that provides stable fitting. Background Technology

[0002] The atrioventricular valves, such as the mitral and tricuspid valves, are one-way valves in the heart. Normal, healthy atrioventricular valves control the flow of blood from the atria to the ventricles, while preventing blood from flowing from the ventricles to the atria. For example, the mitral valve, located between the left atrium and left ventricle, controls the flow of blood from the left atrium to the left ventricle, while preventing blood from flowing from the left ventricle to the left atrium. Specifically, the mitral valve consists of a pair of leaflets, an anterior leaflet and a posterior leaflet. When the edges of the anterior and posterior leaflets align, the mitral valve closes completely, preventing blood from flowing from the left ventricle to the left atrium. When organic or functional changes occur in the leaflets of the mitral valve or its related structures, the anterior and posterior leaflets may not align properly. Consequently, when the left ventricle contracts, the mitral valve cannot close completely, causing blood to flow back from the left ventricle to the left atrium, leading to a series of pathophysiological changes known as "mitral regurgitation."

[0003] Surgical treatment for mitral regurgitation typically involves procedures such as edge-to-edge suturing of the valve. However, these procedures are characterized by complexity, high cost, significant patient trauma, high risk of complications, long hospital stays, and painful recovery. Interventional valve clipping involves inserting a valve clipping device into the mitral valve to pull the misaligned leaflets closer together, reducing or eliminating the leaflet gap and thus treating the regurgitation.

[0004] Existing valve clamping devices include a clamping body, a support body, and an elastic body. The elastic body is sleeved outside the support body and positioned between two clamping arms of the clamping body, so that each leaflet is clamped between one clamping arm and one side of the elastic body. This allows the elastic body to adapt to the leaflet spacing through deformation, thereby adjusting the traction of the clamping arms on the leaflets. The elastic body includes a deformable mesh-like main body, one end of which is fixed to the lower end of the support body between the two clamping arms, and the other end is a free end surrounding the upper end of the support body. However, when the two clamping arms are closed, the elastic body is compressed and deformed, resulting in circumferential flattening and significant axial elongation. This causes a significant axial displacement of the free end of the elastic body towards the upper end of the support body, leading to instability in the fit between the elastic body and the leaflet. Furthermore, because the free end of the elastomer undergoes a significant upward displacement, the top of the elastomer becomes a tapered shape, which prevents the top of the elastomer from adhering to the leaflet. The adhesion height between the elastomer and the leaflet is limited and insufficient. The adhesion area between the elastomer and the leaflet varies depending on the size of the elastomer's deformation, resulting in unstable radial support force and adhesion state of the elastomer to the leaflet, which in turn affects the treatment effect of reflux. Summary of the Invention

[0005] In view of this, this application provides a valve clamping device and valve clamping system with stable fit to solve the problem of unstable fit between the elastomer and the valve leaflet in the prior art.

[0006] In a first aspect, embodiments of this application provide a valve clamping device that provides stable adhesion, comprising:

[0007] Support components;

[0008] Adjusting member, the adjusting member being sleeved on the supporting member; and

[0009] A clamping member, which is rotatably connected to the support member and is disposed on the outside of the adjusting member and can be opened or closed relative to the adjusting member;

[0010] The adjusting member is constructed as a flexible three-dimensional structure, comprising a first constricted end, a second constricted end, an outer layer, an inner layer disposed between the outer layer and the support member, and a flip layer; the first constricted end and the second constricted end are both sleeved on the outside of the support member, the flip layer transitionally connects one end of the inner layer to the outer layer, and the other end of the inner layer is connected to at least one of the first constricted end and the second constricted end;

[0011] The first constricted end and the second constricted end are fixedly disposed relative to the support member; or, the first constricted end and the second constricted end are fixed in relative position, but can move within a small range relative to the support member along the axial direction of the support member.

[0012] Secondly, embodiments of this application provide a valve clamping system, including a delivery device and a valve clamping device with stable adhesion as described above, wherein the delivery device is detachably connected to the valve clamping device.

[0013] The valve clamping device and valve clamping system provided in this application embodiment are based on fitting the first and second closing ends of the adjusting member onto the outside of the support member, with a flip layer transition connecting one end of the inner layer to the outer layer, and the other end of the inner layer connected to at least one of the first and second closing ends. Thus, when the clamping member closes relative to the adjusting member to hold the leaflet between the adjusting member and the clamping member, since the first and second closing ends are fixed relative to the support member, or the relative positions of the first and second closing ends are fixed, and they can move slightly relative to the support member along the axial direction, the inner layer will pull the flipped layer in the axial direction. The flipped layer converts the axial pulling force of the inner layer on it into a radial supporting force on the outer layer. The inner layer and the flipped layer work together to limit the lengthening of the adjusting member in the axial direction when squeezed by the clamping member, and to limit the displacement of the flipped layer in the axial direction. At the same time, the flipped layer and the inner layer of the adjusting member can form a shape with a concave center and bulging edges, avoiding the insufficient fit between the top of the elastomer and the valve in the prior art, which is concave and concave. This allows the fitting between the adjusting member and the leaflet to be stable and sufficient, and the valve clamping device can firmly hold the leaflet, reducing the risk of the leaflet falling off between the clamping member and the adjusting member, improving the implantation stability of the valve clamping device, and improving the surgical effect. Attached Figure Description

[0014] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0015] Figure 1 This is a schematic diagram of the valve clamping device with stable adhesion provided in the first embodiment of this application in the unfolded state of the clamping member.

[0016] Figure 2 yes Figure 1 A partial structural diagram of the adjusting and supporting components of the valve clamping device.

[0017] Figure 3 yes Figure 1 A partial structural diagram of the adjusting component of the valve clamping device.

[0018] Figure 4 yes Figure 1 A three-dimensional structural diagram of the adjusting component of the valve clamping device.

[0019] Figure 5 yes Figure 4 A bottom view of the adjusting component of the valve clamping device.

[0020] Figure 6 yes Figure 1 A schematic diagram of the valve clamping device in the first closed state.

[0021] Figure 7 yes Figure 1 A schematic diagram of the valve clamping device in the second closed state.

[0022] Figures 8-12 yes Figure 1 A schematic diagram of a scenario where a valve clamping device performs edge-to-edge repair of the mitral valve via a catheter.

[0023] Figure 13 This is a schematic diagram of the valve clamping device with stable adhesion provided in the second embodiment of this application, in the unfolded state of the clamping member.

[0024] Figure 14 yes Figure 13 A partial structural diagram of the valve clamping device.

[0025] Figure 15 yes Figure 13 A schematic diagram of the adjusting component of the valve clamping device.

[0026] Figure 16 yes Figure 13 A schematic diagram of the valve clamping device in the closed state.

[0027] Figure 17 This is a partial structural schematic diagram of the valve clamping device with stable adhesion provided in the third embodiment of this application.

[0028] Figure 18 This is a partial structural schematic diagram of the valve clamping device with stable adhesion provided in the fourth embodiment of this application.

[0029] Figure 19 This is a schematic diagram of the valve clamping device with stable adhesion provided in the fifth embodiment of this application, with the clamping member in a closed state.

[0030] Figure 20 yes Figure 19 A schematic diagram of the adjusting component of the valve clamping device.

[0031] Figure 21 This is a schematic diagram of the valve clamping device with stable adhesion provided in the sixth embodiment of this application, with the clamping member in the unfolded state.

[0032] Figure 22 yes Figure 21 A partial structural diagram of the valve clamping device.

[0033] Figure 23 yes Figure 21 A schematic diagram of the valve clamping device in the closed state.

[0034] Figure 24 This is a schematic diagram of the valve clamping device with stable adhesion provided in the seventh embodiment of this application, with the clamping member in the unfolded state.

[0035] Figure 25 yes Figure 24 A partial structural diagram of the valve clamping device.

[0036] Figure 26 This is a schematic diagram of the valve clamping system provided in the eighth embodiment of this application.

[0037] Figures 27-31 yes Figure 26 A schematic diagram of a mitral valve clipping system performing edge-to-edge repair of the mitral valve via the apical approach.

[0038] Explanation of main component symbols

[0039] Valve clipping system 1000, 2000

[0040] Valve clamping devices 100, 100A, 100B, 100C, 100D, 100E, 100F, 100G

[0041] Support components 10, 10E, 10F, 10G

[0042] First end 110, 110E, 110F, 110F, 110G

[0043] Second end 120, 120E, 120G

[0044] Connecting parts 11, 11E, 11G

[0045] First connection structures 111, 111E, 111G

[0046] Connectors 20, 20C

[0047] Weld layer 201

[0048] First connector 21C

[0049] Second connector 22C

[0050] Adjusting parts 30, 30A, 30B, 30C, 30D

[0051] Radial space 301, 301C

[0052] Entering passage 303

[0053] First Channel 304

[0054] Second Channel 305

[0055] First end 310

[0056] Second end 320

[0057] First closing ends 31, 31A, 31B, 31C

[0058] Second closing ends 32, 32A, 32B, 32C

[0059] Outer layer 33, 33A, 33B, 33C, 33D

[0060] Inner layers 34, 34A, 34B, 34C, 34D

[0061] First inner layer segment 341A, 341B, 341C

[0062] Second inner layer sections 342A, 342B, 342C

[0063] Bending parts 343A, 343B

[0064] Flip layers 35, 35A, 35B, 35C, 35D

[0065] First flipped segment 351A, 351B, 351C

[0066] Second flipped segment 352A, 352B, 352C

[0067] 36D adapter layer

[0068] Clamping parts 50, 50E, 50F

[0069] Pivots 52, 614

[0070] clamp arms 53, 53E, 53F

[0071] Flanged section 531

[0072] Anchoring part 532E

[0073] Arc-shaped structure 533E

[0074] Drive components 61, 61E, 61F

[0075] Drive shafts 611, 611E, 611F

[0076] Connector 612, 612E, 612F

[0077] Connecting rods 613 and 613E

[0078] 614F Flexible Drive Arm

[0079] Automatic closing unit 615E

[0080] Axial groove 617E

[0081] gripper 63, 63F

[0082] Gripping arms 631, 631F

[0083] Capture Units 632 and 632F

[0084] Fixed base 70

[0085] Locking mechanism 80

[0086] Locking component 81

[0087] Unlock part 82

[0088] Conveying device 200

[0089] Push sheath 210

[0090] Second connection structure 211

[0091] Outer sheath 220

[0092] splicing structure 300

[0093] The following detailed description, in conjunction with the accompanying drawings, will further illustrate this application. Detailed Implementation

[0094] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of this application.

[0095] First, it's important to clarify that in interventional medicine, along the device delivery path, the end of the device closer to the operator is typically called the proximal end, and the end farther from the operator is called the distal end. Specifically, for delivery devices used to deliver and release implantable devices into a patient, the distal end refers to the end that can be freely inserted into an animal or human body, while the proximal end refers to the end that is operated by the user or machine. In the rotation of objects like cylinders and tubes, the direction of the central axis is defined as the axial direction, the circumferential direction is the direction around the axis of the cylinder or tube (perpendicular to the axis and also perpendicular to the cross-sectional radius), and the radial direction is the direction along the diameter or radius. The axial, circumferential, and radial directions together constitute the three orthogonal directions of a cylinder. It is worth noting that the term "end" appearing in terms such as "proximal end," "distal end," "one end," "the other end," "first end," "second end," "initial end," "end," "both ends," "free end," "upper end," and "lower end" is not limited to end heads, endpoints, or end faces, but also includes portions extending axially and / or radially from the end head, endpoint, or end face on the element to which the end head, endpoint, or end face belongs. The above definitions are for convenience only and should not be construed as limiting this application.

[0096] It is understood that the terminology in the specification, claims, and accompanying drawings of this application is for describing specific embodiments only and is not intended to limit this application. The terms "first," "second," etc., in the specification, claims, and accompanying drawings of this application are used to distinguish different objects, not to describe a specific order. Unless the context clearly states otherwise, the singular forms "a" and "described" are also intended to include the plural forms. The term "comprising" and any variations thereof are intended to cover non-exclusive inclusion. Furthermore, this application can be implemented in many different forms and is not limited to the embodiments described herein. The purpose of providing the following specific embodiments is to facilitate a clearer and more thorough understanding of the disclosure of this application, wherein terms indicating direction such as up, down, left, and right refer only to the position of the illustrated structure in the corresponding drawings.

[0097] The following description provides preferred embodiments for carrying out this application; however, this description is for the purpose of illustrating the general principles of this application and is not intended to limit the scope of this application. The scope of protection of this application shall be determined by the appended claims.

[0098] Example 1

[0099] Please see Figures 1 to 7The valve clamping device 100 with stable fit provided in Embodiment 1 of this application includes a support member 10, an adjusting member 30, and a clamping member 50. The adjusting member 30 is sleeved on the support member 10. The clamping member 50 is rotatably connected to the support member 10 and is disposed on the outside of the adjusting member 30, and can be opened or closed relative to the adjusting member 30. The adjusting member 30 is constructed as a flexible three-dimensional structure. The adjusting member 30 includes a first closing end 31, a second closing end 32, an outer layer 33, an inner layer 34 disposed between the outer layer 33 and the support member 10, and a flipping layer 35. Both the first closing end 31 and the second closing end 32 are sleeved on the outside of the support member 10. The flipping layer 35 transitionally connects one end of the inner layer 34 to the outer layer 33. In this embodiment, the other end of the inner layer 34 is connected to the first closing end 31. In some other embodiments, the other end of the inner layer 34 may also be connected to the second closing segment 32.

[0100] In this embodiment, both the first constricting end 31 and the second constricting end 32 are fixedly disposed relative to the support member 10. It is understood that in some other embodiments, the relative positions of the first constricting end 31 and the second constricting end 32 can be fixed (i.e., the axial distance between the first constricting end 31 and the second constricting end 32 is a constant and they cannot rotate relative to each other), and can move within a small range relative to the support member 10 along its axial direction. "Small range movement" means that the axial movement distance of the first constricting end 31 and the second constricting end 32 is much smaller than the axial length of the support member 10. Specifically, the first constricting end 31 and the second constricting end 32 can synchronously move within a range of 1mm-10mm, preferably within a range of 1mm-3mm, which meets the requirement of "small range movement".

[0101] Those skilled in the art should understand that the aforementioned Figure 1 This is merely one example of a stable valve clamping device 100 and does not constitute a limitation on the stable valve clamping device 100. Furthermore, the stable valve clamping device 100 may include, but is not limited to, other types of devices. Figure 1 The device may include more or fewer components, or a combination of certain components, or different components. For example, the valve clamping device 100 with stable adhesion may also include a positioning imaging element, etc.

[0102] To describe it more clearly, the two ends along the object's own axial direction are defined as the first end and the second end, respectively; Figures 1-31 In the illustration, when describing the first or second end of an object, the lower end of the object is the first end and the upper end is the second end. The support member 10 has a certain axial length and includes a first end 110 and a second end 120 arranged opposite each other.

[0103] The support member 10 includes a connector 11 for detachable connection to the delivery device. The connector 11 and the delivery device can be detachably connected together by means of threaded connection, snap-fit ​​connection, or the like. Specifically, the connector 11 is releasably connected to the distal end of the delivery device. The operator pushes the valve clamping device 100 to the patient's mitral valve and then operates the valve clamping device 100 remotely to clamp the anterior and posterior leaflets of the mitral valve together. Once the leaflets of the mitral valve are aligned edge-to-edge, the operator can release the connection between the delivery device and the connector 11, allowing the valve clamping device 100 to be released and remain in the patient's body as an implant to maintain the alignment of the leaflets and reduce mitral regurgitation.

[0104] In this embodiment, the connecting portion 11 is disposed on the second end 120 of the support member 10, wherein the first end 110 of the support member 10 is its distal end, and the second end 120 of the support member 10 is its proximal end. Specifically, the connecting portion 11 is provided with a first connecting structure 111, and the conveying device is provided with a second connecting structure that cooperates with and is fixed to the first connecting structure 111 and is detachably connected. For example, the first connecting structure 111 is a locking hole, and the second connecting structure is a locking block; or, the first connecting structure 111 is a locking block, and the second connecting structure is a locking hole; or, both the first connecting structure 111 and the second connecting structure are S-shaped buckle structures. When the first connecting structure 111 and the second connecting structure are cooperated and fixed, the conveying device can convey the valve clamping device 100. When the first connecting structure 111 is detached from the second connecting structure, the conveying device separates from the valve clamping device 100. It should be understood that the structure of the support member 10 described herein is merely an example and is not intended to limit the scope of this application. Other structures of the support member 10 adopted by those skilled in the art based on the teachings of this application are all within the scope of protection of this application.

[0105] The support member 10 is constructed as a hollow tubular structure to achieve linkage between the support member 10 and the conveying device. The tubular structure can be, but is not limited to, a circular tube, a square column tube, or a flat circular tube. In this embodiment, the support member 10 is a circular tube, as mentioned above, the distal end of the circular tube is the first end 110, and the proximal end of the circular tube is the second end 120.

[0106] The adjusting member 30 includes a first end 310 and a second end 320 disposed opposite to each other. In this embodiment, the first end 310 of the adjusting member 30 is fixedly connected to the support member 10, and the second end 320 of the adjusting member 30 is located in the flip layer 35. This stable valve clamping device 100 has an unfolded state and a closed state. The unfolded state refers to the adjusting member 30 being in a natural state without external force, that is, the adjusting member 30 is in a fully expanded working state. The closed state refers to the adjusting member 30 being clamped by the clamping member 50, that is, the adjusting member 30 is in a partially expanded working state. In the closed state, the clamping member 50 can have various forms with different clamping angles or different clamping forces. Optionally, the second end 120 of the support member 10 is located inside the adjuster 30 in both the closed and unfolded states. That is, the second end 120 of the support member 10 can be surrounded and shielded by the partial flip layer 35 near the second end 320 of the adjuster 30, so that it will not protrude from the adjuster 30, preventing the second end 120 of the support member 10 from directly contacting the leaflet, avoiding wear of the leaflet by the second end 120 of the support member 10 with the long-term beating of the heart, and improving the safety of implantation.

[0107] The adjusting member 30 is a three-dimensional mesh structure made of shape memory material. Therefore, under different clamping angles or clamping forces of the clamping member 50, the adjusting member 30 can adapt to the gaps between different leaflets and undergo adaptive deformation, thereby adjusting the degree of traction of the valve clamping device 100 on the leaflets. Optionally, the adjusting member 30 is a three-dimensional mesh structure formed by weaving filaments with shape memory function; or, it is a three-dimensional mesh structure formed by cutting rods or tubes with shape memory function. Specifically, after the shape memory material is woven or cut, it is heat-treated to shape the adjusting member 30 so that it can have a specific shape. When subjected to external force, such as compression by the clamping member 50, the adjusting member 30 can deform and tends to restore its original shape, thereby providing support for the clamping member 50. For example, for adjacent leaflets of the tricuspid valve that are relatively thin and fragile (such as the anterior and posterior leaflets, the anterior and septal leaflets, or the posterior and septal leaflets), the clamping member 50 can close at a larger clamping angle to avoid excessive stress on the leaflets and prevent perforation or tearing. For adjacent leaflets of the mitral valve (i.e., the anterior and posterior leaflets), the clamping member 50 can close at a smaller clamping angle to provide greater clamping force on the leaflets. Optionally, the three-dimensional mesh structure includes multiple grids formed by interwoven braided filaments, each grid having a polygonal mesh shape, such as, but not limited to, quadrilaterals. The braided filaments can include one or more strands. Multiple strands are wound or woven side by side to form the braided filaments. The radial dimension of the braided filaments can be 0.06mm-0.20mm. The material of the braided filaments is selected from biocompatible metal materials such as nickel-titanium alloys, stainless steel, and cobalt-chromium alloys, with nickel-titanium alloys being preferred.

[0108] With the same degree of closure of the clamping member 50, the adjusting member 30 can adapt to the spacing between different leaflets by undergoing adaptive deformation, thereby adjusting the degree of traction of the leaflets by the stable valve clamping device 100. The porosity of the three-dimensional mesh structure is preferably in the range of 30% to 80%, so that the adjusting member 30 has both adaptive deformation capability and sufficient radial support strength. Optionally, the mesh density of the inner layer 34 is greater than that of the outer layer 33, which makes the outer layer 33 of the adjusting member 30 more adaptable to the spacing between different leaflets and undergo adaptive deformation, and makes the deformation capacity of the inner layer 34 of the adjusting member 30 less than that of the outer layer 33. On the one hand, when the adjusting member 30 is not clamped by the clamping member 50, the outer layer 33 has a relatively large deformation capacity, so the outer layer 33 can unfold relatively quickly relative to the inner layer 34, improving surgical efficiency and giving the outer layer 33 better flexibility and compliance, so as to avoid the influence of cardiac motion on the leaflets. On the other hand, when clamped by the clamping member 50, the inner layer 34 has a relatively small deformation capacity, so the inner layer 34 can pull the flipping layer 35 in the axial direction. The flipping layer 35 converts the axial pulling force of the inner layer 34 into a radial supporting force on the outer layer 33, thereby increasing the overall radial supporting force of the adjusting member 30 on the leaflets and improving the implantation stability of the valve clamping device 100.

[0109] The overall shape of the adjusting member 30 is approximately an inverted cone. In both the unfolded and closed states, the diameter of the adjusting member 30 gradually increases from its first end 310 to its second end 320. The first end 310 forms the apex of the inverted cone, and the portion near the second end 320 forms the base. The adjusting member 30 forms an axial insertion channel 303 through which the support member 10 passes, with the second end 120 of the support member 10 located within the insertion channel 303. Specifically, the insertion channel 303 includes a first channel 304 formed by the inner layer 34 and a second channel 305 formed by the partially flipped layer 35. The first channel 304 and the second channel 305 are connected, and the second end 120 of the support member 10 is located within the second channel 305. The first closing end 31, the second closing end 32, the inner layer 34, the outer layer 33, and the flipped layer 35 together enclose a radial space 301, allowing the inner layer 34, the outer layer 33, and the flipped layer 35 of the adjusting member 30 to mutually restrain each other and transmit and convert forces, thereby making the valve clamping device 100 fit more closely to the valve leaflet and effectively improving the fatigue resistance of the adjusting member 30. The radial dimension of the opening at the first end of the insertion channel 303 is equal to or slightly larger than the radial dimension of the support member 10, and the radial dimension of the opening at the second end of the insertion channel 303 is larger than the radial dimension of the support member 10, thus providing space for the conveying device (see...). Figure 8Sufficient space is reserved between the second connecting structure (200) and the first connecting structure 111 of the support member 10 to prevent the conveying device (see 200) from being connected. Figure 8 200) Hook adjustment component 30.

[0110] like Figures 2-5 As shown, it is worth noting that the flip layer 35 is constructed as a bent structure that flips inward from the edge of the outer layer 33 and extends to the inner layer 34. The axial cross-section of the flip layer 35 is arc-shaped. Thus, when the clamping member 50 closes relative to the adjusting member 30 to hold the leaflet between the adjusting member 30 and the clamping member 50, the inner layer 34 pulls the flipped layer 35 axially. The flipped layer 35 converts the axial pulling force of the inner layer 34 into a radial supporting force on the outer layer 33. The inner layer 34 and the flipped layer 35 work together to limit the axial elongation of the adjusting member 30 when squeezed by the clamping member 50, and to limit the axial displacement of the flipped layer 35. At the same time, the flipped layer 35 and the inner layer 34 of the adjusting member 30 can form a shape with a concave center and bulging edges, avoiding the insufficient fit between the elastomer top and the valve in the prior art due to its tapered shape. This allows the adjusting member 30 to fit stably and fully with the leaflet, and the valve clamping device 100 can firmly hold the leaflet, reducing the risk of the leaflet falling off between the adjusting member 30 and the clamping member 50, improving the implantation stability of the valve clamping device 100, and improving the surgical outcome. In addition, the inner layer 34 and the flipped layer 35 can wrap around the connecting portion 11 of the support member 10 when the adjusting member 30 is compressed by the clamping member 50, thereby preventing the second end 120 of the support member 10 from damaging the leaflet and improving the safety of the operation.

[0111] The valve clamping device 100 with stable fit also includes a connector 20. The first closing end 31 and / or the second closing end 32 are connected to the support member 10 via the connector 20. The connector 20 is fixedly connected to the first closing end 31 and / or the second closing end 32 and is fixedly disposed relative to the support member 10. The fixed connection method between the first closing end 31 and / or the second closing end 32 and the support member 10 includes, but is not limited to, welding, bonding, pressing, fusion, etc. Optionally, the fixed connection method between the first closing end 31 and / or the second closing end 32 and the support member 10 is welding. In this embodiment, the first closing end 31 and the second closing end 32 are fixedly connected to the support member 10 via the same connector 20. In some other embodiments, where both the first closing end 31 and the second closing end 32 are fixedly connected to the same connector 20, the connector 20 can move slightly relative to the support member 10 along the axial direction of the support member 10 to drive the entire adjusting member 30 to move slightly. The term "small-range movement" refers to a movement distance of the connecting member 20 that is much smaller than the axial length of the support member 10. Specifically, the connecting member 20 can move axially relative to the support member 10 within the range of 1mm-10mm, preferably within the range of 1mm-3mm, which meets the definition of "small-range movement." Optionally, in some embodiments, the valve clamping device 100 with stable fit further includes a limiting structure, which limits the movement distance of the adjusting member 30 along the axial direction of the support member 10. The limiting structure can be provided on the support member 10.

[0112] In this embodiment, both the first constricted end 31 and the second constricted end 32 are fixedly connected to the support member 10 via the same connector 20. Both the first constricted end 31 and the second constricted end 32 are sleeved on the outside of the support member 10. The first constricted end 31 and the second constricted end 32 are relatively close to the first end 110 of the support member 10. In other embodiments, the first constricted end 31 and the second constricted end 32 are connected to the support member 10 via different connectors 20.

[0113] The connector 20 is constructed as a cylindrical structure. In this embodiment, the first constricted end 31 and the second constricted end 32 are both inserted into the inner cavity of the cylindrical structure from the same end. Specifically, the first constricted end 31 and the second constricted end 32 are both inserted into the connector 20 from the upper end and fixedly connected to the connector 20. In some embodiments, the first constricted end 31 and the second constricted end 32 can be inserted into the inner cavity of the cylindrical structure from opposite ends, respectively. Optionally, the connector 20 and the support member 10 are made of the same material, such as stainless steel.

[0114] Optionally, the axial length of the outer layer 33 is equal to the axial length of the inner layer 34, thereby allowing the inner layer 34 to provide a greater tensile force to the flipping layer 35 in the axial direction. The flipping layer 35 can convert this tensile force into a radial supporting force on the outer layer 33. The flipping layer 35 converts the axial tensile force of the inner layer 34 into a radial supporting force on the outer layer 33. The combined action of the inner layer 34 and the flipping layer 35 can limit the axial elongation of the adjusting member 30 when compressed by the clamping member 50, and also limit its flipping. Layer 35 is displaced axially, and the flipped layer 35 and inner layer 34 of the adjusting member 30 can form a shape with a concave center and bulging edges, avoiding the insufficient fit between the elastomer top and the valve due to its tapered shape in the prior art. This allows the adjusting member 30 to fit stably and fully with the leaflet, and the valve clamping device 100 can firmly hold the leaflet, reducing the risk of the leaflet falling off between the adjusting member 30 and the clamping member 50, improving the implantation stability of the valve clamping device 100, and improving the surgical outcome.

[0115] In this embodiment, the inner layer 34 is constructed as an integral structure. Both the inner layer 34 and the outer layer 33 include a first end and a second end, the first end of the inner layer 34 is connected to the first closing end 31, the second end of the inner layer 34 is connected to the flip layer 35, the first end of the outer layer 33 is connected to the second closing end 32, and the second end of the outer layer 33 is connected to the flip layer 35.

[0116] The outer layer 33 is located radially outside the inner layer 34. The inner layer 34 extends radially outward from its first end to its second end. The outer layer 33 extends radially outward from its first end to its second end. The radial distance between the inner layer 34 and the outer layer 33 gradually increases from the first end of the outer layer 33 toward the second end of the outer layer 33. In this embodiment, the distance between the inner layer 34 and the central axis of the adjusting member 30, and the distance between the outer layer 33 and the central axis of the adjusting member 30, both gradually increase from the first end 310 of the adjusting member 30 toward the second end 320 of the adjusting member 30. Both the inner layer 34 and the outer layer 33 are funnel-shaped, that is, the area enclosed by the inner layer 34 and the area enclosed by the outer layer 33 are funnel-shaped. Therefore, when the adjusting member 30 is clamped by the clamping member 50, the change in the outer contour of the adjusting member 30 closely matches the change in the clamping angle of the clamping member 50, so that the valve fits more reliably between the adjusting member 30 and the clamping member 50, thereby improving the implantation stability of the valve clamping device 100 and improving the surgical outcome.

[0117] Optionally, in some embodiments, the exterior of the regulating member 30 is covered with a biocompatible film. In other embodiments, both the exterior and interior of the regulating member 30 are covered with a biocompatible film. Optionally, the interior and / or exterior of the outer layer 33 are covered with a biocompatible film. On one hand, the film covering the regulating member 30 can act as a flow-blocking membrane to seal backflowing blood from the clamping gap, improving the treatment effect of reflux and preventing blood from entering the regulating member 30 and forming a thrombus; on the other hand, the film can make the valve clamping device 100 with a stable fit more biocompatible. The material of the film includes, but is not limited to, biocompatible polymers such as polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (EPTFE), polyester, and silicone resin. In some embodiments, a drug coating may be provided on the membrane to reduce the probability of some inflammations and chronic diseases in the body caused by the membrane.

[0118] In this embodiment, the clamping member 50 is rotatably connected to the first end 110 of the support member 10, so that the clamping member 50 can unfold or close around the adjusting member 30 and centered on the pivot 52 rotatably connected to the first end 110 of the support member 10. During the process of the clamping member 50 closing around the adjusting member 30 centered on the pivot 52 to clamp the leaflet, the adjusting member 30 is clamped by the clamping member 50.

[0119] The clamping angle of the clamping element 50 can be designed based on factors such as the patient's degree of mitral valve closure and / or the degree of deformation of the adjusting element 30. For example, as Figure 6 As shown, in application scenarios using the same adjusting element 30, when the patient's mitral regurgitation is severe, the clamping angle between the clamping element 50 and the adjusting element 30 is relatively small; for example... Figure 7 As shown, when the patient's mitral regurgitation is mild or moderate, the clamping angle of the clamping member 50 and the clamping adjustment member 30 is relatively large. Therefore, by controlling the clamping angle of the clamping member 50, the valve clamping device 100 can be used to clamp leaflets with different degrees of regurgitation, thus expanding the applicability of the valve clamping device 100. Furthermore, when clamping adjacent leaflets of the more fragile tricuspid valve, the clamping angle of the clamping member 50 and the clamping adjustment member 30 can be controlled to be larger than when clamping the mitral valve.

[0120] Specifically, the clamping member 50 includes one or more clamp arm assemblies, each clamp arm assembly including multiple clamp arms 53, such as two, three, or more. In this embodiment, the clamping member 50 includes one clamp arm assembly, which includes two clamp arms 53 symmetrically arranged relative to the adjusting member 30. It is understood that the clamp arm assemblies and the number of clamp arms 53 in each assembly are merely examples and are not specifically limited. Those skilled in the art can select an appropriate number of clamp arm assemblies as needed, such as two or more. It is also understood that three or more clamp arms 53 can be provided in each clamp arm assembly as needed. For example, the anterior leaflet, posterior leaflet, and septal leaflet of the tricuspid valve can be clamped simultaneously using three relatively openable clamp arms 53 to treat tricuspid regurgitation; or, two leaflets of the anterior leaflet, posterior leaflet, and septal leaflet of the tricuspid valve can be clamped using a pair of clamp arms 53 to alleviate or treat tricuspid regurgitation. It should be noted that the following detailed description will use the clamping and repair of two leaflets as an example. Specifically, the two leaflets can be the anterior and posterior leaflets of the mitral valve, or the anterior and posterior leaflets, anterior leaflet and septum leaflet, or posterior leaflet and septum leaflet of the tricuspid valve.

[0121] Optionally, each clamp arm 53 is further provided with a flanged section 531 at its end. The end of the clamp arm 53 refers to the end of the clamp arm 53 away from its rotating connection part, i.e., the pivot 52, or the free end of the clamp arm 53. The flanged section 531 includes an arc surface that is flipped outward toward the end of the clamp arm 53. Optionally, the radius of the arc surface is 1mm-2mm. When the clamp arm 53 is closed relative to the adjusting member 30 to clamp the leaflet between them, the leaflet and the arc surface of the flanged section 531 fit together, increasing the support area of ​​the leaflet at the end of the clamp arm 53. This can avoid local force concentration on the leaflet at the end of the clamp arm 53 and effectively reduce the damage to the leaflet caused by repeated friction between the edge of the clamp arm 53 and the leaflet during heartbeat. After the clamp arm 53 is against the adjusting member 30, the flipped layer 35 of the adjusting member 30 protrudes axially from the flanged section 531 to ensure that the length of the leaflet clamped between the clamp arm 53 and the flipped layer 35 is greater than the length of the clamp arm 53.

[0122] The atrioventricular valve clamping device 100 also includes a drive member 61 connected to the clamping member 50 to drive the clamping member 50 to unfold or close relative to the adjusting member 30. Specifically, the drive member 61 is connected to each clamp arm 53, for example, the drive member 61 is connected to two clamp arms 53 in a set of clamp arms 53 to drive each clamp arm 53 to rotate around the adjusting member 30, thereby causing the clamp arm 53 to move closer to or away from the adjusting member 30. In the delivery state, the drive member 61 drives the two clamp arms 53 to close around the adjusting member 30, thereby reducing the outer diameter of the valve clamping device 100 and facilitating delivery; after the valve clamping device 100 unfolds in the heart, the drive member 61 drives the clamp arms 53 to clamp the leaflets between the clamp arms 53 and the adjusting member 30, thereby achieving leaflet clamping.

[0123] In some embodiments, the valve clamping device 100 further includes a gripping member 63 that can be unfolded or closed relative to the adjusting member 30. The gripping member 63 is disposed between the clamping member 50 and the adjusting member 30. The gripping member 63 includes one or more gripping arm groups. Each gripping arm group includes multiple gripping arms 631, such as two, three, or more. In this embodiment, the gripping member 63 includes a gripping arm group, which includes two gripping arms 631 symmetrically arranged relative to the adjusting member 30. Optionally, the number of gripping arm groups corresponds one-to-one with the number of clamping arm groups, and the number of gripping arms 631 in each gripping arm group corresponds one-to-one with the number of clamping arms 53 in each clamping arm group, so that the gripping arms 631 cooperate with the clamping arms 53 to achieve the leaflet capture function. A grasping unit 632 is provided on the side of the gripping arm 631 facing the clamping arm 53. The grasping unit 632 is configured with multiple barbs spaced apart on the gripping arm 631, thereby improving the gripping ability of the gripping arm 631 on the leaflet. Optionally, the barbs are elastic.

[0124] In the transport state, the gripper 63 is at least partially housed on the inner surface of the clamping member 50. The gripper 63 is at least partially embedded within the clamping member 50. Specifically, the clamp arm 53 has a groove with a notch facing the adjusting member 30, and the gripper arm 631 is at least partially accommodated in the groove of the clamp arm 53, thereby reducing the outer diameter of the atrioventricular valve clamping device 100 and facilitating transport. After the clamp arm 53 and the gripper arm 631 cooperate to capture the valve leaflets, the gripper arm 631 presses the valve leaflets into the groove of the clamp arm 53, which can increase the contact area between the clamp arm 53 and the valve leaflets and increase the clamping force on the valve leaflets.

[0125] The valve clamping device 100 also includes a fixed base 70 fixedly connected to the support member 10. The clamping member 50 is rotatably connected to the fixed base 70 via a pivot 52. Specifically, each clamping arm 53 is rotatably connected to the fixed base 70. The second end (i.e., the upper end) of the fixed base 70 is fixedly connected to the first end 110 of the support member 10. It should be noted that, for ease of explanation, this part is defined here as the term "fixed base 70," and the structure that realizes the function of the fixed base 70 can also be the first end 110 of the support member 10 itself. Therefore, the definition of the term "fixed base 70" should not constitute a limitation on the scope of this application. Each clamping arm 53 in each group is rotatably connected together on the fixed base 70 via a pivot 52. Under the drive of the drive member 61, each clamping arm 53 cooperates with each other to unfold and close together around the adjusting member 30.

[0126] In this embodiment, the driving member 61 includes a driving shaft 611, a connecting seat 612, and two connecting rods 613. One end of each connecting rod 613 is rotatably connected to the clamping member 50, and the other end is rotatably connected to the connecting seat 612. One end of the driving shaft 611 is fixedly connected to the connecting seat 612, and the other end is movably mounted in the fixed base 70. Specifically, one end of each connecting rod 613 is rotatably connected to a corresponding clamp arm 53, and the other end is rotatably connected to the connecting seat 612 via a pivot 614; that is, each clamp arm 53 is rotatably connected to the connecting seat 612 via a connecting rod 613 on its corresponding side. The driving shaft 611 movably passes through the fixed base 70. When the driving shaft 611 slides axially relative to the fixed base 70, it drives the connecting rods 613 to rotate and causes the clamp arms 53 to unfold or close around the pivot 52 between them and the fixed base 70. In some embodiments, the fixed base 70 can be omitted, meaning the driving shaft 611 can also be directly movably mounted in the support member 10.

[0127] Specifically, when the drive shaft 611 moves axially relative to the fixed base 70 toward the first end 110 of the support member 10, it drives the connecting rod 613 to move. Under the pull of the connecting rod 613, the two clamping arms 53 rotate around the pivot 52 and open relative to each other. When the drive shaft 611 moves axially relative to the fixed base 70 toward the second end 120 of the support member 10, the connecting rod 613 pushes the clamping arms 53 to rotate around the pivot 52, causing the two clamping arms 53 to close. The connecting seat 612 can be any structure such as a hemisphere, a spherical crown, or a bullet shape to make it easier to push the valve clamping device 100 into the body. The drive shaft 611 and the connecting seat 612 can be an integral structure or a non-integral structure. To ensure the safety after implantation, the drive shaft 611 and the connecting seat 612 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 high hardness.

[0128] In some embodiments, the valve clamping device 100 further includes a locking mechanism 80 disposed in the fixed base 70. The locking mechanism 80 includes an unlocked state and a locked state. The locking mechanism 80 includes a locking member 81 and an unlocking member 82 that cooperates with the locking member 81. In the unlocked state, the locking member 81 is subjected to a pulling force from the conveying device on the unlocking member 82, thereby releasing the restriction on the relative movement between the drive shaft 611 and the fixed base 70. In the locked state, the locking member 81 is not subjected to a pulling force from the conveying device on the unlocking member 82, and the locking member 81, under its own elastic force, locks the drive shaft 611, that is, restricts the relative movement between the drive shaft 611 and the fixed base 70, thereby realizing a self-locking function. In the conveying state, the locking member 81 restricts the relative movement between the drive shaft 611 and the fixed base 70, thereby ensuring that the clamping member 50 remains closed relative to the adjusting member 30 and the supporting member 10, preventing accidental unfolding of the clamping member 50. Upon reaching the vicinity of the mitral valve, the operation of the conveying device 200 causes the unlocking member 82 to exert a pulling force on the locking member 81, thus unlocking the restriction of the locking member 81 on the drive shaft 611. This allows the drive member 61 to drive the clamping member 50 to unfold relative to the adjusting member 30 and the supporting member 10 and support the leaflet. After clamping the leaflet, the pulling force of the unlocking member 82 on the locking member 81 is released. The locking member 81, under its own elastic force, locks the drive shaft 611 and enters a locked state. At this time, the locking member 81 again restricts the relative movement between the drive shaft 611 and the fixed base 70, thereby maintaining the clamping state of the leaflet. In this embodiment, the locking member 81 includes an elastic steel sheet, and the unlocking member 82 includes an unlocking wire. It is understood that in other embodiments, any existing suitable locking mechanism 80 may be used, which will not be described in detail here.

[0129] Please refer to the following: Figures 8 to 12 This application also provides a valve clamping system 1000, including a valve clamping device 100 with stable adhesion and a delivery device 200. The distal end of the delivery device 200 is detachably connected to the delivery device 200 and is used to deliver the valve clamping device 100 to the heart.

[0130] Please refer to the following: Figures 8 to 12 The following example illustrates the use of the valve clamping device 100 provided in the first embodiment by taking the mitral valve approached and repaired via the left atrium (LA) as an example.

[0131] Step 1: As Figure 8 As shown, the operating delivery device 200 pushes the drive shaft and the valve clamping device 100 connected thereto from the left atrium, through the mitral valve to the left ventricle (LV).

[0132] Step 2: Adjust the valve clamping device 100 to be close to the anterior and posterior leaflets of the mitral valve.

[0133] Step 3: As Figure 9 As shown, the unlocking device is operated to unlock the locking device in the fixed base, and the drive shaft is driven by the conveying device 200 to drive the clamp arm 53 to open. The direction of the clamp arm 53 is adjusted so that the clamp arm 53 is perpendicular to the mitral valve mating line.

[0134] Step 4: As Figure 10 As shown, the entire valve clamping device 100 is retracted proximally so that the clamp arm 53 supports the valve leaflet on the ventricular side.

[0135] Step 5: As Figure 10 As shown, the gripper 63 is released, and the gripper arm presses the leaflet on the atrial side. The anterior and posterior leaflets of the mitral valve are clamped between a pair of clamp arms 53 and the gripper arm, thereby gripping the leaflet.

[0136] Step 6: As Figure 11 As shown, when the anterior and posterior leaflets of the mitral valve are captured between a pair of clamping arms 53 and a gripping arm, the drive shaft is pulled proximally by the conveying device 200, causing the drive shaft to retract proximally, thereby driving the clamping arms 53 to close and clamp the leaflets.

[0137] Step 7: Disconnect the valve clamping device 100 from the delivery device 200, then remove the delivery device from the body, resulting in the following... Figure 12 As shown in the implantation state, the valve clamping device 100 pulls the anterior and posterior leaflets of the mitral valve toward each other, resulting in a double-perforated mitral valve, thus completing the edge-to-edge repair of the mitral valve.

[0138] After the valve clamping device 100 is implanted, the elastic adjusting member 30 fills the space between the anterior and posterior leaflets of the clamped mitral valve and provides radial support for the leaflets. The adjusting member 30 has a buffering effect on the pulsating leaflets, thereby making the degree of traction of the valve clamping device 100 on the leaflets adjustable to avoid damaging the leaflets.

[0139] Example 2

[0140] Please refer to the following: Figure 1 , Figures 13-15 The valve clamping device 100A provided in the second embodiment of this application has a similar structure to the valve clamping device 100 of the first embodiment. The difference lies in the structure of the adjusting member 30A in the second embodiment, which is different from that in the first embodiment. It should be noted that the remaining structure of the valve clamping device 100 in the second embodiment is the same as that in the first embodiment, and will not be described again here.

[0141] Specifically, in the second embodiment, the inner layer 34A includes a first inner layer segment 341A and a second inner layer segment 342A. The flip layer 35 includes a first flip segment 351A and a second flip segment 352A. For example... Figure 14 and Figure 15 As shown, the section above dashed line a is the first flipping segment 351A, and the section below dashed line b is the second flipping segment 352A. One end of the first inner layer segment 341A is connected to the first closing end 31A, and the other end is connected to the first flipping segment 351A. One end of the second inner layer segment 342A is connected to the second closing end 32A, and the other end is connected to the second flipping segment 352A. The outer layer 33A is connected between the first flipping segment 351A and the second flipping segment 352A. The flipping openings of the first flipping segment 351A and the second flipping segment 352A are axially opposite to each other along the adjusting member 30A. Specifically, the cross-sections of both the first flipping segment 351A and the second flipping segment 352A are arc-shaped. In this embodiment, the maximum circumferential length of the first flipping segment 351A is greater than the maximum circumferential length of the second flipping segment 352A, wherein the second flipping segment 352A is closer to the pivot (see...). Figure 1 (52) so that the overall shape of the adjusting member 30A can better conform to the shape of the clamping member 50 when the adjusting member 30A is clamped.

[0142] Both the first closing end 31A and the second closing end 32A are inserted into the lower end of the connector 20 and fixedly connected to it. The first closing end 31A and the second closing end 32A can be fixed to the inner wall of the connector 20 by means of bonding, welding, riveting, fusion, etc. Optionally, a welded layer 201 is formed around the upper end of the connector between the first closing end 31A and the second closing end 32A to improve the stability and reliability of the connection. The first inner layer segment 341A is connected to the second inner layer segment 342A through the connector 20. In this embodiment, a bent portion 343A is formed on the side of the first inner layer segment 341A near the first closing end 31A, so that the radial distance between each part of the first inner layer segment 341A and the support member 10 does not change significantly. The radial cross-section of the bent portion 343A is an arc shape that is concave towards the first end 310 of the adjusting member 30A. The area enclosed by the first inner layer segment 341A is approximately cylindrical; the area enclosed by the second inner layer segment 342A is approximately funnel-shaped. The axial length of the inner layer is equal to the axial length of the outer layer 33A, allowing the inner layer to provide greater tensile force to the flipped layer 35A. In this embodiment, the connector 20 can be fixedly connected to the support member 10. In other embodiments, the connector 20 can also move slightly relative to the support member 10 along its axial direction. The outer layer 33A is connected to the first flipped segment 351A and the second flipped segment 352A at both ends. The outer layer 33A is located radially outside the inner layer 34A, extending radially outward relative to the support member 10 from the second flipped segment 352A toward the first flipped segment 351A.

[0143] Please see Figure 16When the clamping member 50 closes relative to the adjusting member 30A to hold the leaflet between the adjusting member 30A and the clamping member 50, the first inner layer segment 341A pulls the first flipping segment 351A axially, and the first flipping segment 351A converts the axial pulling force of the first inner layer segment 341A into a radial supporting force on the outer layer 33A; the second inner layer segment 342A pulls the second flipping segment 352A axially, and the second flipping segment 352A also converts the axial pulling force of the second inner layer segment 342A into a radial supporting force on the outer layer 33A. The first inner layer segment 341A and the first flipping segment 351A... The combined action of section A and the second inner layer 342A with the second flip section 352A restricts the axial elongation of the adjusting member 30A when it is squeezed by the clamping member 50, and restricts the axial displacement of the first flip section 351A and the second flip section 352A. At the same time, the first inner layer 341A and the first flip section 351A of the adjusting member 30A can form a shape with a concave center and bulging edges, avoiding the insufficient fit between the top of the elastomer and the valve in the prior art where the top is a tapered shape. This allows the adjusting member 30A to fit stably and fully with the leaflet, and the valve clamping device 100A can firmly clamp the leaflet.

[0144] Example 3

[0145] Please refer to the following: Figure 1 and Figure 17 The valve clamping device 100B provided in the third embodiment of this application is structurally similar to the valve clamping device 100 of the first embodiment. The difference lies in the structure of the adjusting member 30B in the third embodiment, which differs from that in the first embodiment. It should be noted that the remaining structure of the valve clamping device 100B in the third embodiment is the same as that in the first embodiment, and will not be described again here.

[0146] Specifically, in the third embodiment, the inner layer 34B includes a first inner layer segment 341B and a second inner layer segment 342B. The flip layer 35B includes a first flip segment 351B and a second flip segment 352B. The first flip segment 351B is above the dashed line a, and the second flip segment 352B is below the dashed line b. One end of the first inner layer segment 341B is connected to the first closing end 31B, and the other end is connected to the first flip segment 351B. One end of the second inner layer segment 342B is connected to the second closing end 32B, and the other end is connected to the second flip segment 352B. The outer layer 33B is connected between the first flip segment 351B and the second flip segment 352B. The flip openings of the first flip segment 351B and the second flip segment 352B are arranged opposite each other along the axial direction of the adjusting member 30B. Specifically, the cross-sections of both the first flip segment 351B and the second flip segment 352B are arc-shaped. In this embodiment, the maximum circumferential length of the first flip segment 351B is greater than the maximum circumferential length of the second flip segment 352B, wherein the second flip segment 352B is closer to the pivot (see...). Figure 1On one side of 52), so that the overall shape of the adjusting member 30B can better conform to the shape when the clamping member clamps the adjusting member 30B.

[0147] Both the first constricting end 31B and the second constricting end 32B are inserted from the upper end of the connector 20 and fixedly connected to the connector 20. In this embodiment, a bent portion 343B is formed on the side of the second inner layer section 342B near the second constricting end 32B, so that the radial distance between each part of the second inner layer section 342B and the support member 10 does not change much. The radial cross-section of the bent portion 343B is an arc shape that is concave towards the first end 310 of the adjusting member 30B. The shape of the outer layer 33B (the area enclosed by the outer layer 33B) is approximately funnel-shaped. The shape of the first inner layer section 341B (i.e., the area enclosed by the first inner layer section 341B) is approximately funnel-shaped; the shape of the second inner layer section 342B (i.e., the area enclosed by the second inner layer section 342B) is approximately cylindrical. When the conveying device is connected to the second end 120 of the support member 10, the conveying device can smoothly enter the funnel-shaped first inner layer section 341B, and the adjusting member 30B will not hook the conveying device. Specifically, the outer diameter of the first inner layer segment 341B gradually increases from the end relatively closer to the second inner layer segment 342B towards the end relatively farther from the second inner layer segment 342B. The axial length of the inner layer 34B is equal to the axial length of the outer layer 33B, so that the inner layer 34B provides sufficient tensile force to the flip layer 35B. The connector 20 can be connected to the support (see...). Figure 1 10) Fixed connection; or, movable within a small range relative to the support member along the axial direction of the support member. The outer layer 33B is connected to the first flip section 351B and the second flip section 352B at both ends, respectively. The outer layer 33B is located radially outside the inner layer 34B, and extends radially outward relative to the support member 10 from the second flip section 352B toward the first flip section 351B.

[0148] When the clamping member 50 closes relative to the adjusting member 30B to hold the leaflet between the adjusting member 30B and the clamping member 50, the first inner layer segment 341B pulls the first flipping segment 351B axially. The first flipping segment 351B converts the axial pulling force of the first inner layer segment 341B into a radial supporting force on the outer layer 33B. The second inner layer segment 342B pulls the second flipping segment 352B axially. The second flipping segment 352B also converts the axial pulling force of the second inner layer segment 342B into a radial supporting force on the outer layer 33B. The first inner layer segment 341B and the first flipping segment 351B... The second inner layer section 342B and the second flip section 352B work together to limit the axial elongation of the adjusting member 30B when it is squeezed by the clamping member 50, and to limit the axial displacement of the first flip section 351B and the second flip section 352B. At the same time, a shape with a central depression and convex edges can be formed between the first inner layer section 341B and the first flip section 351B of the adjusting member 30B, avoiding the insufficient fit between the top of the elastomer and the valve due to its tapered shape in the prior art. This allows the adjusting member 30B to fit stably and fully with the leaflet, and the valve clamping device 100B to firmly clamp the leaflet.

[0149] Example 4

[0150] Please refer to the following: Figure 1 and Figure 18 The valve clamping device 100C provided in the fourth embodiment of this application is structurally similar to the valve clamping device 100 of the first embodiment. The difference lies in the structure of the adjusting member 30C in the fourth embodiment, which differs from that in the first embodiment. It should be noted that the remaining structure of the valve clamping device 100C in the fourth embodiment is the same as that in the first embodiment, and will not be described again here.

[0151] Specifically, in the fourth embodiment, the inner layer 34C includes a first inner layer segment 341C and a second inner layer segment 342C. The flip layer 35C includes a first flip segment 351C and a second flip segment 352C. The first flip segment 351C is above the dashed line a, and the second flip segment 352C is below the dashed line b. One end of the first inner layer segment 341C is connected to the first closing end 31C, and the other end is connected to the first flip segment 351C. One end of the second inner layer segment 342C is connected to the second closing end 32C, and the other end is connected to the second flip segment 352C. The outer layer 33C is connected between the first flip segment 351C and the second flip segment 352C. The flip openings of the first flip segment 351C and the second flip segment 352C are arranged opposite each other along the axial direction of the adjusting member 30C. Specifically, the cross-sections of both the first flipping section 351C and the second flipping section 352C are arc-shaped, meaning that the flipping openings of the first flipping section 351C and the second flipping section 352C are arc-shaped. The maximum circumferential length of the first flipping section 351C is greater than the maximum circumferential length of the second flipping section 352C, which complements the shape of the clamping member 50, facilitating the clamping member 50 to clamp the adjusting member 30C.

[0152] The outer layer 33C has a shape that is approximately funnel-shaped (the area enclosed by the outer layer 33C). The first inner layer segment 341C and the second inner layer segment 342C have shapes that are approximately funnel-shaped or bowl-shaped. Optionally, the first inner layer segment 341C has a shape that is approximately bowl-shaped (i.e., the area enclosed by the first inner layer segment 341C), and the second inner layer segment 342C has a shape that is approximately funnel-shaped (the area enclosed by the second inner layer segment 342C).

[0153] The first constricted end 31C and the second constricted end 32C are connected to the support member 10 via different connectors 20C. Specifically, the connectors 20C include a first connector 21C connected to the first constricted end 31C and a second connector 22C connected to the second constricted end 32C. The first constricted end 31C is inserted into and fixedly connected to the first connector 21C from its upper end, and the second constricted end 32C is inserted into and fixedly connected to the second connector 22C from its lower end. Both the first connector 21C and the second connector 22C are fixedly connected to the support member 10; alternatively, the first connector 21C and the second connector 22C can move synchronously along the axial direction relative to the support member 10 within a small range. The methods of fixing the first connector 21C to the first closing end 31C, the methods of fixing the second connector 22C to the second closing end 32C, and the methods of fixing the first connector 21C, the second connector 22C, and the support member 10 include, but are not limited to, welding, bonding, pressing, and fusion. The axial length of the inner layer 34C is less than the axial length of the outer layer 33C. The support member 10, the first closing end 31C, the second closing end 32C, the inner layer 34C, the outer layer 33C, and the flipping section together enclose a radial space 301C. The outer layer 33C extends radially inward from top to bottom toward the support member 10, and the outer layer 33C is located radially outside the inner layer 34C.

[0154] Example 5

[0155] Please refer to the following: Figure 1 and Figures 19 to 20 The valve clamping device 100D provided in the fifth embodiment of this application is structurally similar to the valve clamping device 100A of the second embodiment. The difference lies in the structure of the adjusting member 30D in the fifth embodiment, which differs from that in the second embodiment. It should be noted that the remaining structure of the valve clamping device 100D in the fifth embodiment is the same as that in the second embodiment, and will not be described again here.

[0156] Specifically, the adjusting member 30D also includes an adapter layer 36D. The adapter layer 36D is connected between the flip layer 35D and the outer layer 33D. The free end of the clamping member 50 is provided with a flange section 531, the shape of which is complementary to the shape of the adapter layer 36D. When the clamping arm 53 closes relative to the adjusting member 30D to clamp the leaflet between them, a portion of the leaflet is also clamped between the adapter layer 36D and the flange section 531. In this embodiment, the adapter layer 36D protrudes axially from the flange section 531, or in other words, the adapter layer 36D is higher than the flange section 531. Thus, on the one hand, the leaflet fits snugly against the curved surface of the flanged section 531 and the curved surface of the adapter layer 36D, increasing the support area of ​​the leaflet at the end of the clamp arm 53. This avoids localized stress concentration on the leaflet at the end of the clamp arm 53, effectively reducing damage to the leaflet caused by repeated friction between the edge of the clamp arm 53 and the leaflet during heartbeats. On the other hand, the leaflet also fits snugly against the curved adapter layer 36D, further increasing the contact area between the leaflet and the adjustment member 30D, improving the elastic fit between the leaflet and the adjustment member 30D, and making the fit between the leaflet and the adjustment member 30D more complete. The structure of the inner layer 34D is the same as that of the inner layer 32A in the second embodiment, and will not be described again here.

[0157] When the clamp arm 53 is closed relative to the adjusting member 30D, the adjusting member 30D is approximately mushroom-shaped. The adapter layer 36D is smoothly and fixedly connected to the flip layer 35D and the outer layer 33D to reduce the damage caused by the adjusting member 30D to the leaflet and to ensure that the adapter layer 36D fits fully with the leaflet.

[0158] Example 6

[0159] Please refer to the following: Figure 13 and Figures 21 to 23 The valve clamping device 100E provided in the sixth embodiment of this application is structurally similar to the valve clamping device 100A in the second embodiment. The difference lies in the structure of the clamping member 50E in the sixth embodiment, which differs from that in the second embodiment. It should be noted that the remaining structure of the valve clamping device 100E in the sixth embodiment is the same as that in the second embodiment, and will not be described again here.

[0160] In the sixth embodiment, the valve clamping device 100E omits the gripping member 63 of the valve clamping device 100A in the second embodiment, thereby simplifying the overall structure of the valve clamping device. The clamping member 50E of the valve clamping device 100E includes a set of clamping arms 53E. Each clamping arm 53E has an anchoring part 532E on the side facing the adjusting member 30A, thereby preventing the leaflet from slipping off the clamping arm 53E after being clamped by the clamping member 50E, ensuring the stability of the valve clamping device 100 in clamping the leaflet. When the clamping arm 53E is closed relative to the adjusting member 30A, the anchoring part 532E can abut against the leaflet, embedding it in the mesh of the mesh structure of the adjusting member, so that the leaflet tissue is fixed by the anchoring part 532E on the basis of the adjusting member and the clamping arm 53E clamping the leaflet. The anchoring part 532E is constructed with a pointed tooth structure.

[0161] The drive unit 61E includes a drive shaft 611E, an automatic closing unit 615E, and at least two connecting rods 613E. One end of each connecting rod 613E is rotatably connected to a corresponding clamping arm 53E, and the other end is directly rotatably connected to the drive shaft 611E via a pin. The drive shaft 611E is movably mounted within the support member 10E. The automatic closing unit 615E connects the two clamping arms 53E, allowing the clamping member 50E to abut against the adjusting member 30A in the closed state.

[0162] The connecting seat 612E and the first end 110E of the support member 10E are integrally formed. The two clamp arms 53E are rotatably connected to the connecting seat 612E. The support member 10 has an axial groove 617E for the pin to pass through. When the drive shaft 611E drives the pin to move towards the first end 110E of the support member 10 in the axial groove 617E, it drives the connecting rod 613E to overcome the obstruction of the automatic closing unit 615E, causing the two clamp arms 53E to open relative to each other.

[0163] In this embodiment, the automatic closing unit 615E is a U-shaped spring, with a clamping arm 53E connected to each end of the U-shaped spring. When the drive shaft 611E does not apply a pushing force to the pin, the U-shaped spring uses its own reset to drive the two clamping arms 53E to tend to close and abut against the adjusting member. It is understood that in other embodiments, the automatic closing unit 615E can also be a V-shaped spring or a torsion spring, etc. The clamping force of the automatic closing unit 615E comes from the elastic force of the spring or torsion spring.

[0164] In this embodiment, a connecting portion 11E that can be detachably connected to the conveying device is provided on the second end 120E of the support member 10. Specifically, the connecting portion 11E and the conveying device can be connected by a threaded structure. The free end of the clamp arm 53E is provided with an arc-shaped structure 533E, which can avoid local force concentration on the leaflets at the end of the clamp arm 53E and effectively reduce the damage to the leaflets caused by repeated friction between the edge of the clamp arm 53E and the leaflets during heartbeat.

[0165] It should be noted that the adjusting component in Embodiment 6 can be replaced with the adjusting component in Embodiment 1, Embodiment 3 or Embodiment 4, which will not be elaborated here.

[0166] Example 7

[0167] Please refer to the following: Figure 1 , Figure 24 and Figure 25 The valve clamping device 100F provided in the seventh embodiment of this application is structurally similar to the valve clamping device 100 of the first embodiment. The difference lies in the structure of the clamping member 50F and the driving member 61F in the seventh embodiment, which differ from those in the first embodiment. It should be noted that the remaining structure of the valve clamping device 100F in the seventh embodiment is the same as that in the first embodiment, and will not be described again here.

[0168] In this embodiment, the proximal end of the clamping member 50F is connected to the support member 10F, and the distal end of the clamping member 50F is connected to the drive shaft 611F. Specifically, the connecting seat 612F and the first end 110F of the support member 10F are integrally formed. One end of the clamping arm 53F of the clamping member 50F is connected to the connecting seat 612F. The drive member 61F includes a drive shaft 611F and at least two elastic drive arms 614F. One end of the elastic drive arm 614F is fixedly connected to one end of the drive shaft 611F, and the other end of the elastic drive arm 614F is connected to the end of the clamping arm 53F away from the connecting seat 612F. The end of the drive shaft 611F away from the elastic drive arm 614F is movably inserted into the support member 10F. The elastic drive arm 614F is used to allow the clamping member 50F to rest against the adjusting member 30 in its natural state.

[0169] One end of the gripping arm 631F is connected to the clamp arm 53F. Multiple gripping units 632F are provided at intervals at the end of the gripping arm 631F.

[0170] In this embodiment, the two clamping arms 53F and the two elastic driving arms 614F are an integral structure, meaning that the two clamping arms 53F themselves are also elastic. When the drive shaft 611F moves toward the first end 110F of the support member 10F, it overcomes the obstruction of the two elastic driving arms 614F, causing the two clamping arms 53F to open relative to each other. When the drive shaft 611F does not apply a pushing force to the elastic driving arms 614F, the two elastic driving arms 614F use their own reset to drive the two clamping arms 53F to tend to close and abut against the adjusting member 30. It is worth noting that when the drive shaft 611F is continuously pushed toward the first end 110F of the support member 10F, the connection between the clamp arm 53F and the elastic drive arm 614F gradually moves toward the drive shaft 611F until the clamp arm 53F and the elastic drive arm 614F are basically in a straight line. Then, the pull line is used to control the gripping arm 631F to fit the adjustment member 30. In this state, it is easier to retract the flattened entire valve clamping device 100F into the push sheath.

[0171] Furthermore, in the seventh embodiment, the valve clamping device 100F can achieve dynamic balance of the valve leaflet clamping state during the clamping and release process. Specifically, when the valve leaflet applies a large pulling force to the valve clamping device 100F, the elastic drive arm 614F and the clamping arm 53F can adjust the clamping angle within a certain range without disengaging from the valve leaflet, preventing damage to the valve leaflet due to excessive pulling force. Since the adjusting member 30 has a certain radial support force, during the adaptive angle adjustment process of the clamping arm 53F, the adjusting member 30 can always elastically conform to the valve leaflet, ensuring the clamping effect and preventing the valve leaflet from falling off.

[0172] It should be noted that the adjusting member 30 in Embodiment 7 can be replaced by the adjusting members 30A, 30B, and 30C in Embodiments 2, 3, or 4, which will not be elaborated here.

[0173] Example 8

[0174] Please refer to the following: Figure 1 and Figure 26 The valve clamping device 100G of the stable valve clamping system 2000 provided in the eighth embodiment of this application has a similar structure to the valve clamping device 100 of the first embodiment. The difference lies in the structure of the support member 10G in the eighth embodiment, which is different from that in the first embodiment. It should be noted that the remaining structure of the valve clamping device 100G in the eighth embodiment is the same as that in the first embodiment, and will not be described again here.

[0175] In the eighth embodiment, the stable valve clamping system 2000 includes a valve clamping device 100G and a delivery device 200. The delivery device 200 is capable of delivering the valve clamping device 100G from outside the body to the vicinity of the mitral valve and clamping the leaflets. The delivery device 200 includes a push sheath 210 and a mandrel movably inserted within the push sheath 210. The push sheath 210 is detachably connected to the support member 10G, and the mandrel of the push sheath 210 is used to drive the opening and closing of the clamping member 50.

[0176] A connecting portion 11G of the support member 10G is disposed at the first end 110G of the support member 10G (i.e., the proximal end of the valve clamping device 100G). The second end 120G of the support member 10G is the distal end of the valve clamping device 100. The push sheath 210 has a certain axial length. The connecting portion 11G is detachably connected to the push sheath 210 of the delivery device 200. Complementary splicing structures 300 are respectively provided on the connecting portion 11G and the push sheath 210 of the delivery device 200. Specifically, the splicing structure 300 includes a first connecting structure 111G disposed on the connecting portion 11G and a second connecting structure 211 disposed on the push sheath 210, which cooperates with and is fixed to the first connecting structure 111G and is detachably connected, thereby realizing a detachable connection between the support member 10G and the delivery device 200. In this embodiment, the first connecting structure 111G and the second connecting structure 211 are constructed as complementary S-shaped buckle structures.

[0177] An outer sheath 220 is movably sleeved outside the push sheath 210. When the outer sheath 220 wraps around the complementary splicing structure 300, the support member 10G remains connected to the conveying device 200. When the outer sheath 220 is retracted and the complementary splicing structure 300 is exposed, the support member 10G and the conveying device 200 can be disconnected.

[0178] Please refer to the following: Figures 26 to 31 The valve clamping system 2000 in this embodiment is suitable for mitral valve repair via the apical approach. The specific usage process is as follows:

[0179] Step 1: As Figure 27 As shown, the operating delivery device 200 pushes the push sheath 210 and the valve clamping device 100 connected thereto from the apex of the heart into the left ventricle and toward the mitral valve.

[0180] Step 2: As Figure 28 As shown, the unlocking mechanism is operated to unlock the locking mechanism in the fixed base, and the spindle of the conveying device 200 is pushed to the distal end to drive the clamp arm 53 to open relative to the fixed base and support the leaflet.

[0181] Step 3: As Figure 29 As shown, the gripper 63 is released, and the gripper 63 presses the leaflets on the atrial side. The anterior and posterior leaflets of the mitral valve are clamped between a pair of clamp arms 53 and the gripper 63, thereby gripping the leaflets.

[0182] Step 4: As Figure 30 As shown, when the anterior and posterior leaflets of the mitral valve are captured between a pair of clamping arms 53 and gripping members 63, the mandrel is pulled proximally to drive the clamping arms 53 to close, thereby clamping the leaflets.

[0183] Step 5: As Figure 31As shown, the valve clamping device 100G is released, and the delivery device 200 is withdrawn from the body.

[0184] It should be noted that before the two clamp arms 53 are closed, the outer sheath 220 should maintain the complementary shape of the spliced ​​structure 300. After the two clamp arms 53 are closed, the connection between the mandrel of the push sheath 210 and the drive shaft 611 should be released first, and the push sheath 210 should be withdrawn to release the connection between the valve clamping device 100G and the delivery device 200.

[0185] It is understood that the valve clipping device and valve clipping system provided in this application can also perform edge-to-edge repair of the tricuspid valve, as long as the appropriate interventional path (such as femoral vein-inferior vena cava-right atrium-right ventricle) is selected and an appropriate number of valve clipping devices are implanted as needed.

[0186] The embodiments of this application have been described in detail above. Specific examples have been used to illustrate the principles and implementation methods of this application. The description of the above embodiments is only for the purpose of helping to understand the method and core ideas of this application. At the same time, for those skilled in the art, there will be changes in the specific implementation methods and application scope based on the ideas of this application. Therefore, the content of this specification should not be construed as a limitation of this application.

Claims

1. A valve clamping device that provides stable fit, characterized in that, include: Support components; An adjusting member, which is sleeved on the supporting member; and A clamping member, which is rotatably connected to the support member and is disposed on the outside of the adjusting member and can be opened or closed relative to the adjusting member; The adjusting member is constructed as a flexible three-dimensional structure, comprising a first constricted end, a second constricted end, an outer layer, an inner layer disposed between the outer layer and the support member, and a flip layer; the first constricted end and the second constricted end are both sleeved on the outside of the support member, the flip layer transitionally connects one end of the inner layer to the outer layer, and the other end of the inner layer is connected to at least one of the first constricted end and the second constricted end; The first constricted end and the second constricted end are fixedly disposed relative to the support member; or, the relative positions of the first constricted end and the second constricted end are fixed, and they can move within a small range relative to the support member along the axial direction of the support member. The valve clamping device also includes a connector; The inner layer has an integral structure, and the connector is fixedly connected to the first and second closing ends, with the first and second closing ends close to the first end of the support member; or... The inner layer includes a first inner layer segment and a second inner layer segment, and the flip layer includes a first flip segment and a second flip segment. One end of the first inner layer segment is connected to the first closing end, and the other end is connected to the first flip segment. One end of the second inner layer segment is connected to the second closing end, and the other end is connected to the second flip segment. The outer layer is connected between the first flip segment and the second flip segment.

2. The valve clamping device with stable adhesion according to claim 1, characterized in that, The flipped layer is constructed as a bent structure that flips inward from the edge of the outer layer and extends to the inner layer.

3. The valve clamping device with stable adhesion according to claim 2, characterized in that, The axial cross-section of the flipped layer is arc-shaped.

4. The valve clamping device with stable adhesion according to claim 1, characterized in that, The axial length of the outer layer is equal to the axial length of the inner layer.

5. The valve clamping device with stable adhesion according to claim 1, characterized in that, The adjusting element is a three-dimensional mesh structure made of shape memory material, and the mesh density of the inner layer is greater than that of the outer layer.

6. The valve clamping device with stable adhesion according to claim 1, characterized in that, When the inner layer includes the first inner layer segment and the second inner layer segment, the first closing end and / or the second closing end are connected to the support member through the connector.

7. The valve clamping device with stable adhesion according to claim 1, characterized in that, The connector is fixed relative to the support; or, the connector can move slightly relative to the support along the axial direction of the support.

8. The valve clamping device with stable adhesion according to claim 1, characterized in that, The first constricted end and the second constricted end are connected to the support member through the same connector; or, the first constricted end and the second constricted end are connected to the support member through different connectors.

9. The valve clamping device with stable adhesion according to claim 8, characterized in that, The connector is constructed as a cylindrical structure, with the first constricted end and the second constricted end both inserted into the inner cavity of the cylindrical structure from the same end; or, the first constricted end and the second constricted end are respectively inserted into the inner cavity of the cylindrical structure from opposite ends.

10. The valve clamping device with stable adhesion according to claim 1, characterized in that, The first inner layer segment is connected to the second inner layer segment via the connector.

11. The valve clamping device with stable adhesion according to claim 10, characterized in that, A bend is formed on the side of the first inner layer segment near the first closing end and / or a bend is formed on the side of the second inner layer segment near the second closing end.

12. The valve clamping device with stable adhesion according to claim 1, characterized in that, The first closing end, the second closing end, the inner layer, the outer layer, and the flipped layer together enclose a radial space.

13. The valve clamping device with stable adhesion according to claim 1, characterized in that, When the inner layer is an integral structure, both the inner layer and the outer layer include a first end and a second end. The first end of the inner layer is connected to the first closing end, and the second end of the inner layer is connected to the flip layer. The first end of the outer layer is connected to the second closing end, and the second end of the outer layer is connected to the flip layer.

14. The valve clamping device with stable adhesion according to claim 13, characterized in that, The inner layer extends radially outward from the first end to the second end of the inner layer, and the outer layer extends radially outward from the first end to the second end of the outer layer. The radial distance between the inner layer and the outer layer gradually increases from the first end of the outer layer toward the second end of the outer layer.

15. The valve clamping device with stable adhesion according to claim 1, characterized in that, The flip openings of the first flip segment and the second flip segment are arranged opposite each other along the axial direction of the adjusting member, and the maximum circumferential length of the first flip segment is greater than the maximum circumferential length of the second flip segment.

16. The valve clamping device with stable adhesion according to any one of claims 1-15, characterized in that, The adjusting member further includes an adapter layer connected between the flip layer and the outer layer. The free end of the clamping member is provided with a flange section, the shape of which is complementary to the shape of the adapter layer.

17. A valve clamping system, characterized in that, It includes a delivery device and a valve clamping device with stable fit as described in any one of claims 1 to 16, wherein the distal end of the delivery device is detachably connected to the valve clamping device with stable fit.

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