Tissue clamping device and clamping system

Abstract

A tissue clamping device and clamping system. The tissue clamping device comprises: a support member having a longitudinal central axis; a spacer, the spacer being sleeved on the support member, the spacer having a proximal constriction and a distal constriction, and the support member passing through the proximal constriction and the distal constriction; a connecting base and a supporting base, wherein the connecting base is fixed relative to a proximal side of the supporting member, the supporting base is fixed relative to a distal side of the supporting member, the constrictions at two ends of the spacer are located between the connecting base and the supporting base, and the diameters of the proximal constriction and the distal constriction are respectively smaller than the maximum radial outer diameters of the connecting base and the supporting base; and a pair of clamping assemblies, wherein the pair of clamping assemblies are oppositely arranged on two sides of the spacer and can be opened or closed relative to the central axis.

Description

Tissue clamping device and clamping system Technical Field

[0001] This invention relates to the field of interventional medical device technology, and in particular to a tissue clamping device and clamping system. Background Technology

[0002] Currently, in edge-to-edge repair techniques used to treat mitral regurgitation, there are two commonly used tissue clamping device designs: mechanical self-locking design and elastic self-locking design. Among them, the elastic self-locking design has self-locking elasticity and better clamping compliance compared to the mechanical self-locking design. It can automatically adjust the clamping tightness of the leaflet to reduce the tension on the leaflet, reduce the risk, and is a superior design.

[0003] In existing elastic self-locking designs, a flexible central filler is usually placed in the middle of the clamp to better fill the gap between the leaflets after clamping, so that the backflow port can be blocked without clamping the leaflets too tightly, reducing tension damage to the leaflets. However, how to stably set the filler and maintain a certain radial support so as to elastically cooperate with the clamping component is particularly important in the design process of elastic self-locking clamps. Summary of the Invention

[0004] To address the aforementioned technical problems, the present invention provides a tissue clamping device and clamping system, which aims to stably set the spacer and ensure that the spacer always maintains good radial support.

[0005] To solve the above-mentioned technical problems, the present invention provides the following technical solution:

[0006] This invention provides a tissue clamping device, comprising:

[0007] A support member having a longitudinal central axis;

[0008] A spacer is sleeved on the support member, the spacer having a proximal end opening and a distal end opening, the support member passing through the proximal end opening and the distal end opening;

[0009] A connecting seat and a supporting seat are provided, wherein the connecting seat is fixed relative to the proximal end of the supporting member, and the supporting seat is fixed relative to the distal end of the supporting member. The two ends of the spacer are located between the connecting seat and the supporting seat, and the diameters of the proximal end and the distal end are respectively smaller than the maximum radial outer diameters of the connecting seat and the supporting seat.

[0010] A pair of clamping components, the pair of clamping components being disposed opposite each other on both sides of the spacer and being openable or closed relative to the central axis.

[0011] In one embodiment, a proximal fixing ring is further included. The proximal fixing ring is sleeved on the support member and fixedly connected to the proximal closing end. The proximal fixing ring and the proximal closing end are fixedly or movably sleeved on the support member.

[0012] In one embodiment, the proximal retaining ring and the proximal constriction are at least partially nested with the connecting seat in the axial direction; the distal side of the connecting seat is recessed with a distal groove, the connecting seat is sleeved on the proximal end of the support member, and the proximal end of the support member and at least a portion of the proximal retaining ring and the proximal constriction are received in the distal groove, and the connecting seat is fixedly connected to the proximal retaining ring or the connecting seat is fixedly connected to the support rod.

[0013] In one embodiment, the proximal retaining ring and the connecting seat are axially opposite each other; the distal end of the connecting seat is recessed with a distal groove, the connecting seat is sleeved on the proximal end of the support member and the proximal end of the support member is received in the distal groove, and the connecting seat is fixedly connected to the support member.

[0014] In one embodiment, the support base has an axially extending through-hole, and the support base is sleeved on the outside of the support member through the through-hole and fixed relative to the support member.

[0015] In one embodiment, the support base is sleeved on the distal end of the support member through the through hole, and the support base, the distal end, and the support member are relatively fixed.

[0016] In one embodiment, a distal fixing ring is further included. The distal fixing ring is sleeved on the outside of the support member and fixedly connected to the distal end. The distal fixing ring and the distal end are fixedly or movably sleeved on the support member.

[0017] In one embodiment, the proximal side of the support base is recessed with a proximal groove communicating with the through hole; the distal fixing ring and the distal constriction are fixedly connected and accommodated in the proximal groove.

[0018] In one embodiment, the spacer is made of a first material, and the support and / or the connector and / or the support base is made of a second material different from the first material.

[0019] In one embodiment, the surface of the spacer opposite to the clamping assembly is a first arc surface that is concave toward the central axis, and in its unconstrained natural state, the radial distance between the two first arc surfaces gradually increases from far to near.

[0020] In one embodiment, there is a maximum spacing between the two first arc surfaces that gradually increase in size from far to near;

[0021] Each of the clamping components includes a clamping portion and a resilient hook-holding portion. One hook-holding portion is positioned between the spacer and the clamping portion. The clamping portion and the hook-holding portion cooperate to clamp tissue. The two resilient hook-holding portions are spaced apart from each other, such that one hook-holding portion is close to the clamping portion. When a pair of clamping portions are closed, the maximum radial distance between the two hook-holding portions is less than the maximum spacing.

[0022] In one embodiment, a pair of hook clamping portions are connected by a hook fixing portion. The support includes a base and a connecting tube located at the distal end of the base. The two radially protruding sides of the root of the connecting tube form protruding portions. The hook fixing portion is provided with a connecting hole through which the connecting tube can pass. The two radially protruding sides of the connecting hole form notches to fit and engage with the protruding portions.

[0023] In one embodiment, an anchoring ring is further included, the outer diameter of which is larger than the minimum diameter of the connecting hole. The anchoring ring is sleeved on the connecting tube at the distal end of the hook fixing part and fixed relative to the connecting tube. The hook fixing part is confined between the base and the anchoring ring.

[0024] In one embodiment, the two sides of the seat body near the center in the width direction are partially convex outward in an arc shape.

[0025] In one embodiment, the hook clamping part is a single-arm structure, the hook clamping part includes a first part near the central axis and a second part connected to the first part; in the unconstrained natural state, the angles between the first part and the second part and their axis of symmetry are α1 and α2, respectively, where α1 is less than α2.

[0026] In one embodiment, the difference between α1 and α2 is between 1 degree and 10 degrees.

[0027] In one embodiment, the axial distance between the proximal end and the distal end is less than the maximum axial height of the spacer.

[0028] In one embodiment, at least the proximal end retraction is located on the distal side of the proximal top of the spacer, and a recessed cavity is formed between the proximal top of the spacer and the proximal end retraction, with at least the distal portion of the connector placed within the recessed cavity.

[0029] The present invention also provides a clamping system, including the tissue clamping device and the conveying assembly described above, wherein the conveying assembly is detachably connected to the tissue clamping device.

[0030] In the tissue clamping device and clamping system of the present invention, the support member directly passes through the spacer, and the two ends of the spacer are fitted onto the support member to form a radially stable constraint. Furthermore, the two ends of the spacer are smaller than the maximum radial outer diameter of the connecting seat and the support seat located on both sides of the support member, so that the two ends of the spacer are always constrained between the connecting seat and the support seat located on both sides of the support member, forming an axial limit. This prevents the spacer from detaching due to compression or other reasons, thus ensuring that the spacer always maintains good radial support. The present invention can effectively ensure the radial support of the spacer while stably setting the spacer. Furthermore, this invention further limits the axial distance between the proximal and distal ends of the spacer to be less than the maximum axial height of the spacer, allowing the tail of the spacer to be concave. This facilitates a shorter overall height of the tissue clamping device, further improving adaptability during transport. The recessed cavity increases the space for component arrangement, allowing for more stable connection methods for each component, particularly enabling axially relative fixing when welding dissimilar materials. This maintains the strength of the load-bearing components and the overall connection, improving product stability and safety. It also allows for greater deformation of the spacer, improving adaptability, especially when the sheath of the tissue clamping device needs to be retracted smoothly. Additionally, the spacer provides excellent radial support when compressed, enhancing the clamping and sealing effect when engaged with the clamping components. Attached Figure Description

[0031] To more clearly illustrate the solutions in this invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are some embodiments of this invention or corresponding prior art. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort. Wherein:

[0032] Figure 1 is a schematic diagram of the structure of an exemplary tissue clamping device of the present invention, showing the natural state after assembly;

[0033] Figure 2 is a half-sectional view of Figure 1;

[0034] Figures 3a to 3d are partial structural schematic diagrams of different connection methods for the support, spacer, and connector;

[0035] Figures 4a to 4d are partial structural schematic diagrams of different connection methods for the support, spacer and connecting seat when the proximal fixing ring is set;

[0036] Figures 5a to 5d are partial structural diagrams of the support, spacer, proximal fixing ring and connecting seat with different connection methods when the proximal tail of the spacer is recessed.

[0037] Figures 6a and 6b are partial structural schematic diagrams of different connection methods for the support member, spacer member, and support base, respectively.

[0038] Figures 7a and 7b are partial structural schematic diagrams of different connection methods of the support, spacer and support base when the remote fixing ring is set;

[0039] Figure 8 is a half-section diagram of the structure when the support, spacer, connecting seat, support seat, proximal fixing ring and distal fixing ring are connected when the proximal tail of the spacer is concave.

[0040] Figure 9 is a three-dimensional schematic diagram of the spacer;

[0041] Figure 10 is a schematic diagram of the structure of the clamping assembly of the exemplary tissue clamping device of the present invention when it is opened;

[0042] Figure 11 is a structural schematic diagram of a pair of clamping components when they are naturally closed. The spacer is not shown in the figure.

[0043] Figure 12 is a schematic diagram of the spacer shape matching when a pair of clamping components are naturally closed and when they are in the self-expanding state when unrestrained. This figure is only a schematic diagram of the interference amount. In reality, the spacer deforms after closing and is in the state shown in Figure 2.

[0044] Figure 13 is a schematic diagram of the spacer deformed under constraint and compression. The dashed line indicates the shape after deformation.

[0045] Figure 14 is a three-dimensional schematic diagram of the hook;

[0046] Figure 15 is a front view schematic diagram of the hook;

[0047] Figure 16 is a three-dimensional schematic diagram of the support base at one angle;

[0048] Figure 17 is a three-dimensional schematic diagram of the support base from another angle;

[0049] Figure 18 is a half-sectional view of the support base;

[0050] Figure 19 is a schematic diagram of the structure of the exemplary tissue clamping device and delivery assembly of the present invention when they are not connected;

[0051] Figure 20 is a schematic diagram of the structure of the exemplary tissue clamping device of the present invention when connected with the delivery assembly;

[0052] Figure 21 is a side view of Figure 20;

[0053] Figure 22 is a perspective view of the connecting seat in an exemplary tissue clamping device of the present invention;

[0054] Figure 23 is a top view of Figure 22; the mandrel passing through the connector is shown in this figure.

[0055] Figures 24a to 24c are schematic diagrams of different implementations of the S-shaped structure of the connector.

[0056] Figure 25 is a schematic diagram of the connection structure between the support arm and the clamping arm of the exemplary tissue clamping device of the present invention. The figure shows the natural state after assembly.

[0057] Figure 26 is a three-dimensional structural schematic diagram of the support arm and clamping arm of the exemplary tissue clamping device of the present invention.

[0058] Figure 27 is a partially enlarged schematic diagram of Figure 26;

[0059] Figure 28 is a plan view of the support arm of an exemplary tissue clamping device of the present invention;

[0060] Figure 29 is a side view of Figure 28. Detailed Implementation

[0061] The technical solutions in the embodiments of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0062] In the description of this invention, it should be noted that the terms "upper," "lower," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the invention. Furthermore, the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance. When an element is referred to as being "fixed to" or "set on" another element, the element may be directly connected to the other element or indirectly connected to the other element through one or more connecting elements. When an element is referred to as being "connected to" another element, it may be directly connected to the other element or connected to the other element through one or more connecting elements.

[0063] It should also be noted that in the field of interventional medical devices, the proximal end refers to the end closer to the operator, while the distal end refers to the end farther from the operator; the direction of the rotational axis of an object such as a cylinder or tube is defined as the axial direction; the circumferential direction is the direction around the axis of the object (perpendicular to the axis and also perpendicular to the cross-sectional radius); the radial direction refers to the direction along the wire diameter or radius. It is important to note 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 point," "both ends," "free end," "upper end," and "lower end" is not limited to the tip, endpoint, or end face, but also includes a portion extending axially and / or radially from the tip, endpoint, or end face on the element to which the tip, endpoint, or end face belongs. The above definitions are for convenience only and should not be construed as limiting the invention.

[0064] The tissue clamping device and clamping system provided by this invention are mainly used for repairing heart valves, especially the mitral and tricuspid valves, to reduce the leaflet gap and alleviate mitral or tricuspid regurgitation. Of course, they can also be used to clamp other tissues.

[0065] Please refer to Figures 1 and 2. This invention provides an exemplary tissue clamping device 100, which is assembled from multiple components. The assembled tissue clamping device 100 includes a support member 1, a spacer 2, a connecting seat 3, a support base 4, and a pair of clamping assemblies 5. Figure 1 shows the tissue clamping device 100 in its natural assembled state. The term "component" in this invention refers to various parts, and can be considered as a minimum unit constituting the tissue clamping device 100. This minimum unit can be defined based on whether it can be further disassembled. For example, the support member 1 is a component, the spacer 2 is a component, the connecting seat 3 is a component, the support base 4 is a component, and one of the clamping assemblies 5 can be a component unit, which in turn includes multiple components.

[0066] Referring again to Figures 1 and 2, the support member 1 of the present invention has a longitudinal central axis oo, which is also the central axis oo of the assembled tissue clamping device 100. Exemplarily, the support member 1 is a tubular member, and a spacer 2 passes through the support member 1 and is sleeved on it. The spacer 2 has a proximal constriction 2a and a distal constriction 2b, which are axially spaced apart. The spacer 2 includes a main body 20 connecting the proximal constriction 2a and the distal constriction 2b, and the main body 20 has a certain axial extension length. A connecting seat 3 is fixed relative to the proximal side of the support member 1, which is the upper side in Figures 1 and 2. The connecting seat 3 is used for detachable connection with the distal end of the delivery assembly. The support seat 4 is fixed relative to the distal end of the support member 1. The ends are relatively fixed. Here, "far end" can refer to a segment at the far end or a segment near the far end. The far end here is the lower side in Figures 1 and 2. The two ends of the spacer 2 are located between the connecting seat 3 and the support seat 4. The diameter of the proximal end 2a is smaller than the maximum radial outer diameter of the connecting seat 3, as shown in Figure 2, where the diameter w2a of the proximal end 2a is smaller than the maximum radial outer diameter w3 of the connecting seat 3. The diameter of the distal end 2b is smaller than the maximum radial outer diameter of the support seat, as shown in Figure 2, where the diameter w2b of the distal end 2b is smaller than the maximum radial outer diameter w4 of the support seat 4. This arrangement constrains the proximal end 2a and the distal end 2b of the spacer 2 between the connecting seat 3 and the support seat 4. In this embodiment, the proximal end 2a and the distal end 2b constrained between the connecting seat 3 and the support seat 4 can be fixed or movable relative to the support rod 1. A pair of clamping components 5 are disposed opposite each other on both sides of the support member 1 and can be opened or closed relative to the central axis oo. Understandably, the pair of clamping components 5 are placed outside the spacer 2, and the spacer 2 fills the cavity enclosed by the pair of clamping components 5 to achieve sealing.

[0067] In the tissue clamping device of the present invention, the support member directly passes through the spacer, and the two ends of the spacer are fitted onto the support member to form a radially stable constraint. Furthermore, the two ends of the spacer are smaller than the maximum radial outer diameter of the connecting seat and the support seat located on both sides of the support member, so that the two ends of the spacer are always constrained between the connecting seat and the support seat located on both sides of the support member, forming an axial limit. This prevents the spacer from detaching due to compression or other reasons, thus ensuring that the spacer always maintains good radial support. The present invention can effectively ensure the radial support of the spacer while stably setting the spacer.

[0068] It should be noted that the "closure" in the proximal closure 2a and / or distal closure 2b of the spacer 2 of the present invention can refer to a single-layer opening. The edge region (a certain radial region) of the single-layer opening can be considered as the "closure". For example, the proximal end of the spacer 2 can be made to have a "hole" by weaving or cutting. The hole or the edge region of the hole can be considered as the closure of the spacer (as shown in Figure 3a, the "hole" on the proximal end of the spacer 2 is the proximal closure 2a). It can also refer to a section with a certain axial extension length at the proximal end and / or distal end of the spacer 2. This section can also be considered as the "closure" of the spacer 2 (as shown in Figure 3b, the section with a certain axial length on the proximal side of the spacer 2 is the proximal closure 2a).

[0069] Please refer to Figures 3a-3d, 4a-4d, and 5a-5d. The connection methods for the support member 1, the spacer 2, and the connecting seat 3 include, but are not limited to, the following embodiments.

[0070] Referring to Figure 3a, a through hole is provided on the proximal side of the main body 20 of the spacer 2. The periphery of the through hole can be a non-destructive end, forming the proximal end constriction 2a. The support member 1 passes through the proximal end constriction 2a, which can be fixedly or movably fitted onto the support member 1. The connecting seat 3 is located on the proximal side of the spacer 2 and is fixed relative to the proximal end of the support member 1. In this embodiment, the diameter w2a of the proximal end constriction 2a is smaller than the maximum radial outer diameter w3 of the connecting seat 3, preventing the proximal end constriction 2a from detaching beyond the connecting seat 3 and effectively ensuring the support of the spacer 2. For example, a distal end groove (not shown) is recessed on the distal side of the connecting seat 3. The connecting seat 3 is fitted onto the proximal end of the support member 1 through the distal end groove and is fixed relative to the support member 1.

[0071] Referring to Figure 3b, an extension of the proximal end of the main body 20 of the spacer 2 forms the proximal constriction 2a, which in this embodiment extends towards the proximal side. In other embodiments, referring to Figure 3c, the proximal constriction 2a may also extend towards the distal side. In the embodiments shown in Figures 3b and 3c, the support 1 passes through the proximal constriction 2a with a certain extension length. The proximal constriction 2a can be fixedly or movably fitted onto the support 1. The proximal constriction 2a with a certain extension length not only facilitates the stability of the proximal end of the spacer 2, but also forms a surface abutment with the support 1 when compressed, facilitating effective radial support of the spacer 2 and improving the clamping effect of the tissue clamping device. The connecting seat 3 is located on the proximal side of the spacer 2 and is fixed relative to the proximal end of the support 1. For example, the distal side of the connecting seat 3 is recessed with a distal groove (not shown), and the connecting seat 3 is fitted onto the proximal end of the support 1 and fixed relative to the support 1. Similarly, in the embodiments shown in Figures 3b and 3c, the diameter w2a of the proximal end 2a is smaller than the maximum radial outer diameter w3 of the connecting seat 3, which prevents the proximal end 2a from going over the connecting seat 3 and detaching, effectively improving the support of the spacer 2.

[0072] Compared with the embodiment shown in Figure 3b, the proximal end 2a of Figure 3c extends toward the distal end, and a section of the proximal end 2a of Figure 3c is located inside the spacer 2. This can shorten the overall height of the tissue clamping device, which is convenient for improving transport compliance, while avoiding excessive metal exposure at the proximal end, which is beneficial for endothelialization.

[0073] Referring to Figure 3d, an extension of the proximal end of the main body 20 of the spacer 2 forms the proximal constriction 2a. In this embodiment, the proximal constriction 2a extends towards the proximal side. The support 1 passes through the proximal constriction 2a with a certain extension length. The proximal constriction 2a can be fixedly or movably fitted onto the support 1. The proximal constriction 2a with a certain extension length not only facilitates the stability of the proximal end of the spacer 2, but also forms a surface abutment with the support 1 when compressed, which facilitates effective radial support of the spacer 2 and improves the clamping effect of the tissue clamping device. In this embodiment, the connecting seat 3 is located on the proximal side of the spacer 2. A distal groove 31 is recessed on the distal side of the connecting seat 3. On the one hand, the distal groove 31 is used to fix it relative to the support 1, and on the other hand, it is used to accommodate the proximal constriction 2a of the spacer 2. For example, the distal groove 31 is provided with a step 32, so that the distal groove 31 has two radial groove diameters. The first groove diameter at the step 32 is smaller than the second groove diameter at the non-step 32. The connecting seat 3 is sleeved on the proximal end of the support member 1 and the inner side of the step 32 is in contact with the outer wall of the support member 1 and can be further fixed. The proximal end opening 2a of the spacer 2, which extends towards the proximal end and has a certain extension length, is accommodated in the distal groove 31 with the second groove diameter. Since the proximal end opening 2a can be fixedly or movably sleeved on the support member 1, the proximal end opening 2a accommodated in the distal groove 31 with the second groove diameter can be fixed or movably relative to the distal groove 31. Similarly, in the embodiment shown in Figure 3d, the diameter w2a of the proximal constriction 2a is smaller than the maximum radial outer diameter w3 of the connecting seat 3, and the proximal constriction 2a is constrained within the distal groove 31 of the connecting seat 3, increasing the difficulty for the proximal constriction 2a to cross the connecting seat 3, thus further effectively ensuring the support of the spacer 2. This embodiment is an optimized solution that considers both longitudinal height and metal leakage. In addition, the outer diameter of the connecting seat 3 in this embodiment can be appropriately increased to improve the stability of the connection with the conveying assembly.

[0074] Referring to Figures 4a to 4d, based on any of the above embodiments, the tissue clamping device 100 further includes a proximal fixing ring 6. The proximal fixing ring 6 can be connected to the proximal closing end 2a. The proximal fixing ring 6 is sleeved on the outside of the support member and fixedly connected to the proximal closing end. The fixedly connected proximal fixing ring 6 and the proximal closing end 2a are fixedly or movably sleeved on the support member 1. The proximal fixing ring 6 can constrain and close the spacer 2, preventing fraying and other issues; it also allows the spacer 2 to have a certain degree of linkage and support during deformation; and it can also facilitate assembly with other components.

[0075] As shown in the embodiment of Figure 4a, this embodiment is based on the embodiment of Figure 3b, further adding a proximal fixing ring 6. A proximal constriction 2a with a certain extension length extends towards the proximal side. The proximal fixing ring 6 is sleeved on the proximal constriction 2a with the extended length and is fixed relative to the proximal constriction 2a. After the proximal fixing ring 6 is fixed relative to the proximal constriction 2a, it can be fixedly or movably sleeved on the support member 1. Alternatively, the proximal constriction 2a and the proximal fixing ring 6 can be sequentially sleeved on the support member 1 and then the three can be fixed relative to each other. It is understood that in this embodiment, the ring diameter of the proximal fixing ring 6 is smaller than the maximum radial outer diameter w3 of the connecting seat 3.

[0076] As shown in the embodiment of Figure 4b, this embodiment is based on the embodiment of Figure 3c, further adding a proximal fixing ring 6. A proximal constriction 2a with a certain extension length extends towards the distal end. The proximal fixing ring 6 is sleeved over the proximal constriction 2a with the extended length and is fixed relative to the proximal constriction 2a. After the proximal fixing ring 6 is fixed relative to the proximal constriction 2a, it can be fixedly or movably sleeved on the support member 1. Alternatively, the proximal constriction 2a and the proximal fixing ring 6 can be sequentially sleeved over the support member 1 before being fixed relative to each other. In this embodiment, the method to achieve relative fixation of the proximal constriction 2a, the proximal fixing ring 6, and the support member 1 can be as follows: the spacer 2 is flipped over from one of the constrictions and sleeved onto the support member 1 (at this time, the inner surface of the spacer 2 is on the outer side), then the proximal fixing ring 6 is sleeved on, further fixing the proximal fixing ring 6, the proximal constriction 2a, and the support member 1. After fixing, the spacer 2 is flipped over through the other constriction, so that the inner surface of the flipped spacer 2 is on the inner side.

[0077] Similarly, compared to the embodiment shown in Figure 4a, the proximal end 2a in Figure 4b extends towards the distal end. A section of the proximal end 2a and the proximal fixation ring 6 in Figure 4b are both located inside the spacer 2. This not only shortens the overall height of the tissue clamping device, facilitating transport compliance, but also avoids excessive metal exposure at the proximal end, promoting endothelialization. Typically, the spacer 2 is covered with a membrane. In the embodiment of Figure 4b, the proximal end 2a and the proximal fixation ring 6, located inside the spacer 2, are both covered inside the membrane, preventing them from being exposed and directly contacting the tissue.

[0078] As shown in the embodiment of Figure 4c, it is based on the embodiment of Figure 3d, with the addition of a proximal fixing ring 6. The proximal constriction 2a with a certain extension length extends toward the proximal side. The proximal fixing ring 6 is sleeved on the proximal constriction 2a with the extension length and is fixed relative to the proximal constriction 2a. After the proximal fixing ring 6 is fixed relative to the proximal constriction 2a, it can be fixedly or movably sleeved on the support member 1. In this embodiment, a step 32 is provided in the distal groove 31 of the connecting seat 3, so that the distal groove 31 has two radial groove diameters. The first groove diameter at the step 32 is smaller than the second groove diameter at the non-step 32. The connecting seat 3 is sleeved on the proximal end of the support member 1, and the inner side of the step 32 is relatively close to the outer wall of the support member 1 and can be further fixed. The proximal end constriction 2a with a certain extension length and the proximal end fixing ring 6 are accommodated in the distal groove 31 with the second groove diameter. Since the proximal end constriction 2a can be fixedly or movably sleeved on the support member 1, the proximal end constriction 2a accommodated in the distal groove 31 with the second groove diameter can be fixed or movably relative to the distal groove 31. In this embodiment, the proximal end constriction 2a is constrained in the distal groove 31 of the connecting seat 3, which increases the difficulty for the proximal end constriction 2a to detach from the connecting seat 3 and effectively ensures the support of the spacer 2.

[0079] In the embodiment shown in Figure 4d, this embodiment includes a proximal fixation ring 6, with a proximal constriction 2a extending towards the proximal side. The proximal fixation ring 6 is sleeved on the proximal constriction 2a and fixed relative to the proximal constriction 2a and the support member 1. Furthermore, a connecting seat 3 is located on the proximal side of the spacer 2, and a distal groove (not shown) is recessed on the distal side of the connecting seat 3. The connecting seat 3 is sleeved on the proximal fixation ring 6 through the distal groove and further fixed relative to the proximal fixation ring 6, thereby achieving relative fixation of the connecting seat 3, the proximal fixation ring 6, the proximal constriction 2a, and the support rod 1. This method not only achieves the connection of multiple components, but also helps to reduce the overall height of the tissue clamping device and improve compliance during delivery; at the same time, axial nesting fixation reduces metal leakage and facilitates endothelialization.

[0080] Please refer to Figures 1, 2, and 8. Based on any of the above embodiments, in order to further reduce the overall height of the tissue clamping device while improving the deformation capacity and support of the intermediate spacer, so that it can cooperate with the clamping assembly to provide excellent clamping and sealing effects, the axial distance H1 between the proximal end 2a and the distal end 2b of the spacer 2 in the tissue clamping device 100 of the present invention is less than the maximum axial height H2 of the spacer 2. This limitation causes the proximal end 2a and / or the distal end 2b of the spacer 2 to necessarily bend inward from the highest or lowest point, so that the end face where the proximal end 2a is located is lower than the nearest end face of the spacer 2; and / or the end face where the distal end 2b is located is higher than the farthest end face of the spacer 2. This inward bending causes the main body 20 of the spacer 2 to include an outer peripheral surface 21 and at least one inner peripheral surface 22 and a radial support surface 23 connecting the outer peripheral surface 21 and the inner peripheral surface 22. A recessed cavity 20a is formed circumferentially on the inner peripheral surface 22. When the proximal constriction 2a and other components such as the fixing ring and connecting seat 3 are connected, the connecting position and each connecting member can be at least partially accommodated within the recessed cavity 20a. As the proximal constriction 2a is recessed, the components are positioned closer to the inner side, which helps to shorten the overall height of the tissue clamping device and further improves its compliance during transport. Furthermore, the recessed cavity 20a increases the space for component arrangement, allowing for more stable connection methods for each component. It also allows for greater deformation of the spacer 2, resulting in better adaptability, especially when the tissue clamping device needs to retract the sheath. Additionally, due to the outer peripheral surface 21, the inner peripheral surface 22, and the radial support surface 23 connecting them, the spacer 2 can form excellent radial support when compressed, thereby improving the clamping and sealing effect when the clamping components are engaged.

[0081] Specifically, referring to Figures 5a to 5d, in this embodiment, at least the proximal end 2a of the tissue clamping device 100 is located on the distal side of the proximal top of the spacer 2, and a recessed cavity 20a is formed between the proximal top of the spacer 2 and the proximal end 2a. At least a portion of the distal end of the connecting seat 3 is placed in the recessed cavity 20a, that is, the proximal tail of the spacer 2 is treated with an inward concave structure.

[0082] Figure 5a shows an embodiment where the proximal end taper 2a of the spacer 2 shown in Figure 4a is recessed. In this embodiment, the proximal end taper 2a is located on the distal side of the proximal top of the spacer 2. The circumferential surface between the proximal top of the spacer 2 and the proximal end taper 2a forms a recessed cavity 20a. At least a portion of the distal ends of the proximal fixing ring 6 and the connecting seat 3 are placed within the recessed cavity 20a. Other structures in this embodiment can be referred to the description in Figure 4a, and will not be repeated here. It should also be noted that this embodiment illustrates a structure with the proximal fixing ring 6. It is understood that the proximal fixing ring 6 may not be included, that is, the proximal end taper 2a can be recessed based on the embodiment shown in Figure 3b.

[0083] Figure 5b shows an embodiment where the proximal end taper 2a of the spacer 2 shown in Figure 4b is recessed. In this embodiment, the proximal end taper 2a is located on the distal side of the proximal top of the spacer 2. The circumferential surface between the proximal top of the spacer 2 and the proximal end taper 2a forms a recessed cavity 20a. At least a portion of the distal end of the connecting seat 3 is placed within the recessed cavity 20a. Other structures in this embodiment can be referred to the description in Figure 4b, and will not be repeated here. It should also be noted that this embodiment illustrates a structure with a proximal fixing ring 6. It is understood that the proximal fixing ring 6 may not be included, that is, the proximal end taper 2a can be recessed based on the embodiment shown in Figure 3c.

[0084] Figure 5c shows an embodiment where the proximal end taper 2a of the spacer 2 shown in Figure 4c is recessed. In this embodiment, the proximal end taper 2a is located on the distal side of the proximal top of the spacer 2. The circumferential surface between the proximal top of the spacer 2 and the proximal end taper 2a forms a recessed cavity 20a. At least a portion of the distal ends of the proximal fixing ring 6 and the connecting seat 3 are placed within the recessed cavity 20a. Other structures in this embodiment can be referred to the description in Figure 4c, and will not be repeated here. It should also be noted that this embodiment illustrates a structure with the proximal fixing ring 6. It is understood that the proximal fixing ring 6 may not be included, that is, the proximal end taper 2a can be recessed based on the embodiment shown in Figure 3d.

[0085] Figure 5d shows an embodiment where the proximal end concave opening 2a of the spacer 2 shown in Figure 4d is recessed. In this embodiment, the proximal end concave opening 2a is located on the distal side of the proximal top of the spacer 2. The circumferential surface between the proximal top of the spacer 2 and the proximal end concave opening 2a forms a recessed cavity 20a. At least a portion of the distal ends of the proximal fixing ring 6 and the connecting seat 3 are placed within the recessed cavity 20a. Other structures in this embodiment can be referred to the description in Figure 4d, and will not be repeated here.

[0086] Referring again to Figures 5a to 5d, the proximal end of spacer 2 is treated with a concave structure, including but not limited to the proximal end of spacer 2 bending inward (as shown in Figure 5b), with the inwardly extending section forming the proximal end taper 2a. Alternatively, the proximal end of spacer 2 bends inward and then bends outward for a section (as shown in Figures 5a, 5c, and 5d), with the outward extending section forming the proximal end taper 2a. Preferably, spacer 2 is a woven mesh formed by braiding yarns, and the bending radius of the concave structure during bending is not less than twice the thickness of the woven mesh to prevent yarn breakage during shaping or difficulty in deformation.

[0087] It should be understood that the connection methods of the aforementioned support member 1, spacer 2, and connecting seat 3, as well as the arrangement method of the spacer, can be combined in any way to form a new technical solution without structural conflict, and all of them are within the protection scope of this application.

[0088] Please refer to Figures 6a-6b and 7a-7b. The connection methods for the support member 1, spacer 2, and support base 4 include, but are not limited to, the following embodiments. It should be understood that the following embodiments can be combined with any of the above embodiments to form different solutions without structural conflict.

[0089] Referring to Figure 6a, a through hole is provided on the distal end of the main body 20 of the spacer 2. The periphery of the through hole can be a non-destructive end. This through hole forms the distal end constriction 2b. The support member 1 passes through the distal end constriction 2b, and the distal end constriction 2b can be fixedly or movably sleeved on the support member 1. The support base 4 is provided with an axially penetrating through-hole (not shown). The support base 4 is sleeved on the outside of the support member 1 through the through-hole and is fixed relative to the support member 1. In this embodiment, the diameter w2b of the distal end constriction 2b is smaller than the maximum radial outer diameter w4 of the support base 4, which prevents the distal end constriction 2b from going over the support base 4 and detaching, effectively ensuring the support of the spacer 2.

[0090] Referring to Figure 6b, an extension of the distal end of the main body 20 of the spacer 2 forms the distal constriction 2b. The support 1 passes through the distal constriction 2b, which has a certain extension length, and the distal constriction 2b is fixedly fitted onto the support 1. The support base 4 has an axially penetrating through-hole (not shown), and the support base 4 is fitted onto the distal constriction 2b outside the support 1 through the through-hole. The support base 4, the distal constriction 2b, and the support 1 are relatively fixed. In this embodiment, the diameter w2b of the distal constriction 2b is smaller than the maximum radial outer diameter w4 of the support base 4, and the distal constriction 2b is fixed between the support base 4 and the support 1, further increasing the difficulty for the proximal constriction 2a to detach over the connecting seat 3, effectively ensuring the support of the spacer 2.

[0091] Referring to Figure 7a, based on any of the above embodiments, the tissue clamping device 100 further includes a distal fixing ring 7. The distal fixing ring 7 can be connected to the distal closing end 2b. The distal fixing ring 7 is sleeved on the outside of the support member 1 and fixedly connected to the distal closing end 2b. The distal fixing ring 7 and the distal closing end 2b are fixedly or movably sleeved on the support member 1. The distal fixing ring 7 not only constrains and closes the spacer 2 to prevent the closing end from fraying, but also ensures that the spacer 2 has a certain degree of linkage and support during deformation; it can also be assembled with other components. In this embodiment, the support base 4 may be provided with a through hole that penetrates the support base 4 axially. The support base 4 is sleeved on the outside of the support member 1 through the through hole and is fixed relative to the support member 1. In this embodiment, the diameter w2b of the distal closing end 2b is smaller than the maximum radial outer diameter w4 of the support base 4.

[0092] Referring to Figure 7b, based on the embodiment shown in Figure 7a, the proximal side of the support base 4 is recessed with a proximal groove 40a that communicates with the through hole; the distal fixing ring 7 and the distal closing opening 2b, which are fixedly connected, are placed in the proximal groove 40a. This not only forms a radial constraint on the distal fixing ring 7 and the distal closing opening 2b, but also further reduces the overall height of the tissue clamping device, ensuring a compact structure, facilitating the fixing of various arrangement methods, and minimizing the welding of dissimilar materials.

[0093] Preferably, the spacer 2 of the present invention is made of a first material, and the support 1 and / or connecting seat 3 and / or support seat 4 are made of a second material different from the first material. The strength of the second material is greater than that of the first material. The proximal fixing ring 6 and / or distal fixing ring 7 are made of either the first material or the second material. More preferably, the spacer 2 is made of the first material, and the support 1, connecting seat 3, and support seat 4 are made of the second material. The first material may be nickel-titanium. The second material may be stainless steel.

[0094] For tissue clamping devices, especially elastic self-locking clamping devices, a large pushing force needs to be applied to overcome their own elastic clamping and open during the opening process. This large pushing force places higher demands on the strength of the load-bearing structural components and connection strength of the product. This strength requirement poses a greater challenge to the relatively fixed use of dissimilar materials.

[0095] Therefore, to ensure the strength of the load-bearing components and the connection strength, when the spacer 2 is made of the first material and the support 1, connecting seat 3, and supporting seat 4 are made of the second material, as shown in Figures 2 and 8, the proximal end 2a of the tissue clamping device 100 is located on the distal side of the proximal top of the spacer 2, and a recessed cavity 20a is formed between the proximal top of the spacer 2 and the proximal end 2a. At least a portion of the distal end of the connecting seat 3 is placed in the recessed cavity 20a, that is, the proximal tail of the spacer 2 is concave. For example, as shown in Figure 2, the proximal end of the spacer 2 bends inward and then bends outward for a period of time, and this outwardly extended section forms the proximal end 2a of the spacer 2. That is, the proximal end 2a with a certain extension length extends towards the proximal side, and the proximal fixing ring 6 is sleeved on the proximal end 2a with the extension length. The proximal fixing ring 6, the proximal end 2a, and the support 1 are relatively fixed. The connecting seat 3 is located on the proximal side of the spacer 2. The distal side of the connecting seat 3 is recessed with a distal groove. The connecting seat 3 is fitted onto the proximal end of the support 1 through the distal groove and is fixed relative to the support 1. The fixed proximal fixing ring 6 is not axially nested with the connecting seat 3. The proximal end 2a, the proximal fixing ring 6, and at least the distal part of the connecting seat 3 are accommodated in the recessed cavity 20a. The overall motion transmission of the clamping device mainly relies on the support, the support seat, and the connecting seat. In this embodiment, the tail of the spacer is designed with an inward concave shape to provide space for welding layout. The welding position is divided into four locations: A, B, C, and D (as shown in Figure 8). The main load-bearing positions are designed as two welding structures of the same material (such as welding at A and welding at D). The spacer itself is subjected to relatively small forces during use. The front and rear ends are positioned by welding with two fixing rings (welding at B and welding at C), which are no longer superimposed, thereby reducing the impact on force transmission.

[0096] In this embodiment, the load-bearing structure (connecting seat 3, support member 1) is welded and fixed with the same material, which has higher support strength. This ensures its own strength while improving the connection strength, reducing the need for welding dissimilar materials. The load-bearing structure will not affect the connection stability of the spacer 2 during the load-bearing process. Conversely, it also avoids the connection stability of the load-bearing structure being affected by the connection stability of the spacer 2, thus ensuring the overall connection strength and stability of the device. In addition, the concave treatment at the tail of the spacer 2 increases the space for the arrangement of each component, enabling the connecting seat 3 and the proximal fixing ring 6 to be fixed independently without axial nesting. This can greatly shorten the overall height of the device, making the conveying process more compliant. At the same time, each component can be placed in the concave cavity as much as possible without affecting the connection with the conveying component, reducing the exposed area of ​​metal parts and facilitating endothelialization after device implantation. In addition, the spacer 2 can also deform in a larger space, making it more adaptable, especially when the clamping device needs to be withdrawn into the sheath.

[0097] Exemplary, the spacer 2 of the present invention can be an elastic mesh structure. It can be made of an elastic material, such as elastic metal wire or elastic polymer filament. In one embodiment, the spacer 2 is woven from nickel-titanium wire. In other embodiments, the spacer 2 is made of elastic sponge or elastic silicone. In yet another embodiment, the spacer 2 can be an airbag structure made of a polymer material.

[0098] The spacer 2 can seal and fill the gap between two tissues, further improving the sealing performance. Furthermore, because the spacer 2 is made of an elastic material, it possesses a certain degree of flexibility and deformability. After clamping, the spacer 2 can act as a buffer, preventing the two clamped tissues (such as two leaflets) from being pulled together and reducing clamping stress. In other embodiments, a membrane (not shown) is provided on the spacer 2, covering its surface to further improve the sealing effect.

[0099] Specifically, please refer to Figures 8 to 10. The surface of the spacer 2 opposite to the clamping assembly 5 is a first arc surface 201 that is concave towards the central axis oo. In the unconstrained natural state, the radial distance between the two first arc surfaces 201 gradually increases from far to near, that is, as shown in Figure 8, the radial distance between the two first arc surfaces 201 gradually increases from bottom to top.

[0100] The spacer 2, with two opposing concave surfaces, is shaped to fit the internal space constructed by a pair of clamping components 5, fully filling the interior of the clamping components 5. Typically, the hook holding part 51 in the clamping component 5 is a sheet-like structure (as shown in Figures 10 and 14). The sheet-like hook holding part 51 abuts against the concave first arc surface 201 and further compresses it, allowing the spacer 2 to deform and fill the space constructed by the clamping components 5, forming an effective seal.

[0101] Please refer to Figures 8-10. The two opposing first arc surfaces 201 of the spacer 2 are connected on the same side by a second arc surface 202, forming two second arc surfaces 202 that bulge outwards relative to the central axis oo of the spacer 2. In other embodiments, the edges of the first arc surface 201 and the edges of the second arc surface 202 can be further connected by a third arc surface. The two bulging second arc surfaces 202 gradually narrow from their midpoint to their two extended ends and approach the support member 1. The two bulging second arc surfaces 202 can extend radially outwards after being compressed by the two first arc surfaces 201, thereby filling both sides of the clamping assembly 5 and improving the sealing effect.

[0102] As shown in Figures 8 and 10, as the radial distance between the two first arc surfaces 201 gradually increases from far to near, a maximum distance w20 is formed between the two first arc surfaces 201 of the spacer 2. This maximum distance is the maximum distance in the self-unconstrained state of the spacer 2.

[0103] Each clamping assembly 5 includes a clamping portion and an elastic hook-holding portion 51. The hook-holding portion 51 is positioned between the spacer 2 and the clamping portion. The clamping portion and the hook-holding portion 51 cooperate to clamp tissue. The two elastic hook-holding portions 51 are spaced apart from each other, so that the hook-holding portion 51 is close to the clamping portion. As shown in Figure 11, when a pair of clamping portions are closed, the maximum radial distance between the two hook-holding portions 51 is w50. As shown in Figures 10 to 12, the maximum radial distance w50 is less than the maximum spacing w20. That is, as shown in Figure 12, the spacer 2 located in the middle will have a certain amount of interference with the clamping assembly 5 in terms of shape fit. When a pair of clamping portions close naturally due to their own elasticity, as shown in Figure 13, the spacer 2 will deform due to the compression of the two hook-holding portions 51. The spacer 2 with the recessed cavity has better adaptability to deformation, is easier to deform, and has better support after deformation.

[0104] When the pair of clamping parts are closed, the two first arc surfaces 201 of the assembled spacer 2 will interfere with the hook clamping part 51 of the corresponding clamping component 5 (see Figure 12). After being constrained by the pair of clamping components 5, the spacer 2 undergoes a certain deformation, ensuring that the spacer 2 fully fills the internal space enclosed by the pair of clamping components, and that the two first arc surfaces 201 are firmly attached to the corresponding clamping components 5, forming a surface abutment, which constitutes a favorable radial support, presenting the initial state after assembly (see Figures 1 and 2). The spacer 2 under this configuration not only has a good sealing effect, but also has a good clamping effect of organizing the clamping device, making it more stable.

[0105] Referring to Figures 14 and 15, in other embodiments, the hook clamping part 51 is a single-arm structure. Two single-arm hook clamping parts 51 can be connected by a hook fixing part 52. The hook fixing part 52 and the single-arm hook clamping parts 51 located on both sides thereon can be integrally formed into a hook 50. The single-arm hook clamping part 51 has only two cutting surfaces. The reduction of cutting surfaces reduces the risk of fatigue fracture due to stress concentration caused by defects in the cutting surfaces.

[0106] The hook clamping part 51 includes a first part 511 near the central axis oo and a second part 512 connected to the first part 511; in the natural state, that is, when the hook 50 is not constrained, the angles between the first part 511 and the second part 512 and their axis of symmetry xx are α1 and α2, respectively, where α1 is less than α2.

[0107] It should be noted that, referring to Figure 15, the angle between the first part 511 and the second part 512 and the axis of symmetry xx is the angle between the bottom surface of the hook clamping part 51 and the axis of symmetry xx in its natural state. In this invention, the angle α1 between the first part 511 and the axis of symmetry xx of the hook clamping part 51 is smaller than the angle α2 between the second part 512 and the axis of symmetry xx. That is, a certain bend is formed at the connection between the first part 511 and the second part 512, causing the second part 512 to bend upwards relative to the first part 511. This design allows the second part 512, which is mainly used for clamping tissue, to have a longer effective clamping length. At the same time, the first part 511, near the root of the axis of symmetry, presses downwards, effectively maintaining the elasticity of the hook. With the same clamping length, this design ensures the elasticity of the hook while making the effective clamping length of the hook clamping part 51 longer, thus improving the clamping stability of the tissue clamping device. In addition, this setting allows for a lower axial height of the entire hook in the closed state, which facilitates miniaturization. That is, while achieving miniaturization, it also ensures elasticity and increases the effective clamping length.

[0108] Preferably, the difference between the included angles α1 and α2 is between 1 degree and 10 degrees. In this embodiment, the difference of 1 degree to 10 degrees includes both endpoints, meaning the difference can be either 1 degree or 10 degrees. This range ensures the elasticity requirement of the hook, maximizes the effective clamping length, and avoids breakage due to excessive bending angle. Furthermore, the extension length of the first part 511 is no greater than one-third of the total length of the hook clamping part 51. Preferably, the extension length of the first part 511 is between one-fifth and one-quarter of the total length of the hook clamping part 51. This range meets the elastic compression requirement while avoiding excessive elasticity due to excessive length of the first part 511, which would increase the required pulling force.

[0109] Referring again to Figures 10, 14, and 15, in one embodiment, an anchor is provided on the elastic hook clamping portion 51. The anchor is disposed on the surface of the elastic hook clamping portion 51 facing the support arm 52 and extends toward the support arm 52. The anchor is used to capture tissue (e.g., leaflet), and when the tissue is captured, the anchor penetrates into the tissue, and the clamping arm 53, the elastic hook clamping portion 51, and the anchor work together to reliably clamp the tissue. There can be one or more anchors. When there are multiple anchors, they are spaced apart on the elastic hook clamping portion 51. Preferably, four rows of barbs are provided on one side of the elastic hook clamping portion 51, with the fourth row of barbs close to the root. When the clamping device captures the leaflet and closes, the fourth row of barbs clamps the edge of the leaflet, increasing the valve clamping capacity. In other embodiments, the number and arrangement of anchors can be set as needed and are not limited thereto.

[0110] Referring to Figures 1, 6a-6b, 7a-7b, and 14-18, the support base 4 includes a base body 41 and a connecting pipe 42 located at the distal end of the base body 41. The connecting pipe 42 extends radially on both sides at its root, forming protrusions 43. The hook fixing part 52 has a connecting hole 52a through which the connecting pipe 42 passes. Notches 52a1 are formed radially on both sides of the connecting hole 52a to fit and engage with the protrusions 43. The end of the connecting pipe 42 furthest from the base body 41 extends beyond the hook fixing part 52 of the hook 50. The engagement of the protrusions 43 and the notches 52a1 creates a circumferential limit between the support base 4 and the hook 50, preventing relative rotation.

[0111] In other embodiments, as shown in Figures 16 and 17, when the proximal side of the support base 4 is recessed with a proximal groove 40a communicating with the through hole, the local areas near the center on both sides of the base body 41 in the width direction bulge outward as arc surfaces 41a. The hole in the support base 4 through which the support member 1 passes is designed as a stepped hole, and the local areas near the center on both sides of the base body 41 in the width direction are made into arc surfaces, which ensures the structural strength of the support base 4 while accommodating the distal fixing ring and the distal end opening without leakage, which helps to reduce the overall height of the device and keep the device compact.

[0112] Furthermore, continuing to refer to Figures 1, 6a-6b, and 7a-7b, the clamping device of the present invention further includes an anchoring ring 8. The outer diameter of the anchoring ring 8 is larger than the minimum diameter of the connecting hole 52a. The anchoring ring 8 is sleeved on the connecting pipe 42 at the distal end of the hook fixing part 52 and is fixed relative to the connecting pipe 42. The hook fixing part 52 is confined between the seat body 41 and the anchoring ring 8. In this embodiment, the hook 50 is axially limited by the anchoring ring 8 being fixed to the connecting pipe 42, avoiding structural connection treatment of the hook 50 during assembly (e.g., welding of the hook), thereby ensuring the strength of the hook 50.

[0113] Please refer to Figure 10. A pair of clamping parts are arranged opposite each other, and the two clamping parts are located on both sides of the central axis oo, and the clamping parts are located on the outside of the spacer 2. For example, each clamping part includes a support arm 52 and an elastic clamping arm 53. The distal ends of two opposing support arms 52 are rotatably connected to form a first connection position at the connection point, and the distal ends of two opposing clamping arms 53 are rotatably connected to form a second connection position at the connection point. The second connection position is located at the distal end of the first connection position in the axial direction. The proximal end of one support arm 52 is hinged to the proximal end of one clamping arm 53, that is, the free end of the support arm 52 is hinged to the free end of the clamping arm 53. In the natural state after assembly, that is, in the initial state when the tissue clamping device 100 is not subjected to external force after assembly (the state shown in Figures 1 and 2), the two clamping arms 53 move closer to each other, causing the two support arms 52 connected to them to also move closer to each other. As the axial distance between the first connection position and the second connection position increases, the proximal ends of the two support arms 52 expand outward and drive the two clamping arms 53 hinged to them to open (as shown in Figure 10). It should be noted that the arrangement of the clamping part is not limited to this.

[0114] Specifically, the distal ends of a pair of clamping arms 53 are connected to the fixed base 9. The distal end of the support arm 52 is rotatably connected to the support base 4. The distal end of the support arm 52 is connected to the support base 4 via a pivot, pin, or hinge. For example, the distal end of the support arm 52 is rotatably connected to the support base 4 via a pivot.

[0115] Please refer to Figure 2 again. In one embodiment, the proximal end of the support arm 52 is hinged to the proximal end of the clamping arm 53. The proximal end of the support arm 52 and the proximal end of the clamping arm 53 are connected by a rotating arm. One end of the rotating arm is fixed relative to the proximal end of the support arm 52, and the other end is rotatably connected to the clamping arm 53.

[0116] Both the clamping arm and the support arm are elastic, and both can be made of a hyperelastic material, possessing excellent elastic deformation characteristics. For example, the hyperelastic material includes one or more shape memory alloys or shape memory polymers. The hyperelastic material is a shape memory alloy selected from the group consisting of copper-zinc-aluminum alloys, copper-aluminum-nickel alloys, nickel-titanium alloys, nickel-titanium-platinum alloys, and nickel-titanium-palladium alloys. Further, the hyperelastic material is a nickel-titanium alloy. The hyperelastic material may also be a shape memory polymer selected from the group consisting of oligo(ε-caprolactone) glycol, oligo(p-dioxane) glycol, polynorbornene, polyisoprene, styrene-butadiene, polyurethane-based materials, and compounds based on vinyl acetate polyesters.

[0117] The present invention also provides an exemplary clamping system, which includes the tissue clamping device 100 described above and a conveying assembly 200, wherein the conveying assembly 200 is detachably connected to the tissue clamping device 100. Specifically, the distal end of the conveying assembly 200 is detachably connected to the connecting seat 3 of the tissue clamping device.

[0118] For example, as one implementation of the detachable connection between the delivery assembly 200 and the tissue clamping device 100, please refer to Figures 19 to 21. The proximal end of the connecting seat 3 of the tissue clamping device 100 is provided with a generally S-shaped structure. Correspondingly, the connecting member at the distal end of the delivery assembly 200 is provided with an inverted S-shaped structure that is adapted to and engages with the S-shaped structure of the connecting seat 3. The two can be engaged and connected, thereby limiting each other axially, and can be disengaged after slight tilting in the circumferential direction.

[0119] Preferably, to achieve connection stability while facilitating disengagement, as shown in Figures 22 and 23, the S-shaped connecting seat 3 has a roughly C-shaped circumferential cross-section, including two protruding clamping arms 3a. An opening 3b is located between the two clamping arms 3a. The axial length w3b of the opening 3b is less than the diameter d of the hole through which the mandrel passes on the connecting seat 3. Generally, this diameter d is slightly larger than or equal to the diameter of the mandrel 200b, thus effectively limiting and supporting the mandrel. Referring to Figures 19-23, the orientation of the opening 3b of the connecting seat 3 is perpendicular to the opening and closing direction of the pair of clamping components, preventing the opening from facing the clamping arm direction, i.e., avoiding the direction of lateral force, thus improving the stability of the tissue clamping device.

[0120] In one embodiment, referring to Figure 24a, the S-shaped structure can be formed by sequentially and tangentially connecting straight segment p1, arc segment p2, arc segment p3, and straight segment p4; the fastening structure is simplified, with the arc segments directly connected tangentially. In another embodiment, referring to Figure 24b, the S-shaped structure can also be formed by sequentially and tangentially connecting straight segment p1, arc segment p2, straight segment p5, arc segment p3, and straight segment p4. In other embodiments, referring to Figure 24c, the S-shaped structure can also be formed by sequentially and tangentially connecting straight segment p1, arc segment p6, arc segment p2, arc segment p3, arc segment p4, and straight segment p4. The straight segments p1 and p4 can be designed as perpendicular ends to the axis or as inclined segments, preferably inclined segments, for easy release. When the force-transmitting spindle is pulled out, the S-shaped structure can quickly slide out and unlock under the action of pushing / pull force or external force; and all the above structures have no sharp edges or corners and have a smooth shape.

[0121] Referring to Figures 1 and 25, each clamping assembly 5 includes an elastic support arm 52 and an elastic clamping arm 53. The distal ends of the two opposing support arms 52 are rotatably connected, forming a first connection position 1a at the connection point. The distal ends of the two opposing clamping arms 53 are rotatably connected, forming a second connection position 2a at the connection point. The second connection position 2a is located at the distal end of the first connection position 1a in the axial direction. The proximal end of one support arm 52 is hinged to the proximal end of one clamping arm 53, that is, the free end of the support arm 52 is hinged to the free end of the clamping arm 53. In the natural state after assembly, that is, the initial state of the tissue clamping device 100 after assembly without external force (as shown in Figures 1 and 25). In the state), the two elastic clamping arms 53 approach each other under their own elastic force, causing the two connected support arms 52 to also approach each other. As the axial distance h between the first connecting position 1a and the second connecting position 2a increases, the proximal ends of the two support arms 52 expand outward and drive the two clamping arms 53 hinged to them to open. As shown in Figure 1 and Figures 25 to 28, the support arm 52 has a preset extension length L. The support arm 52 with the preset extension length L includes at least a first segment 11 with a first extension length L1. The width of the first segment 11 gradually changes along the extension direction. The first segment 11 with the gradually changing width has a minimum width W0 belonging to the support arm 52.

[0122] The tissue clamping device of the present invention achieves this by gradually varying the width of at least a portion of the elastic support arm, resulting in a minimum width within the support arm on the first segment of the gradually varied support arm. When the thrust spindle pushes the distal structure of the clamping arm forward, the axial distance between the first and second connecting positions increases, and the hinge between the support arm and the clamping arm rotates outward to open. During the opening process, the narrowest segment of the support arm with the minimum width preferentially undergoes significant bending deformation in accordance with the bending direction. Subsequently, as the tissue clamping device gradually opens, the support arm gradually extends. The entire process reduces the opening force and minimizes the force accumulation, achieving a smooth and non-bouncy opening effect, avoiding damage to the patient's heart, improving product safety, and reducing risks. Furthermore, when the entire tissue clamping device is subjected to external pressure, causing the clamping arm to deform inward, the gradually varied width of the support arm reduces its resistance to deformation, facilitating the clamping arm's contraction.

[0123] The elastic clamping arm and support arm can both be made of a hyperelastic material, possessing excellent elastic deformation characteristics. For example, the hyperelastic material includes one or more shape memory alloys or shape memory polymers. The hyperelastic material is a shape memory alloy selected from the group consisting of copper-zinc-aluminum alloys, copper-aluminum-nickel alloys, nickel-titanium alloys, nickel-titanium-platinum alloys, and nickel-titanium-palladium alloys. Further, the hyperelastic material is a nickel-titanium alloy. The hyperelastic material may also be a shape memory polymer selected from the group consisting of oligo(ε-caprolactone) glycol, oligo(p-dioxane) glycol, polynorbornene, polyisoprene, styrene-butadiene, polyurethane-based materials, and compounds based on vinyl acetate polyesters.

[0124] Understandably, when the support arm 52 includes only the first segment 11, the preset extension length L is equal to the first extension length L1, and the minimum width W0 on the first segment 11, whose width gradually changes, belongs to the minimum width within the support arm 52. Of course, the support arm 52 may also include other extension segments. In this case, the preset extension length L is equal to the sum of the first extension length L1 of the first segment 11 and the extension lengths of the other extension segments. The width of the other extension segments along the extension direction can be varied or unchanged, and can be of equal or unequal diameter. However, the first segment 11, whose width gradually changes, always has a minimum width W0, and the width of the other extension segments is always greater than this minimum width W0. Therefore, the minimum width W0 on the first segment 11 belongs to the minimum width within the support arm 52, which includes multiple extension segments. It should also be noted that the width mentioned in this application should refer to the effective width in the width direction, that is, the sum of the widths that actually provide support. For example, in the embodiments shown in Figures 1 and 25-28, the two sides of the first segment 11 of the support arm 52 are both arc-shaped surfaces. The width gradually changes through the two arc-shaped surfaces, and the part between the two arc-shaped surfaces is the part that actually provides support. Therefore, the minimum effective width of the first segment 11 with gradually changing width is W0. In another embodiment, the first segment 11 of the support arm 52 has a cut hole with arc-shaped outward protrusions on both sides, so that the width of the first segment 11 gradually changes along its extension direction. The two parts outside the cut hole actually provide support. In this embodiment, the minimum effective width of the first segment 11 with gradually changing width is the sum of W01 and W02, i.e., W0 = W01 + W02. It should be understood that the way to achieve a gradual change in width is not limited to the above. For example, the width can also gradually increase or decrease along the extension direction. Other embodiments made by those skilled in the art based on the intention of gradual change in this invention are also within the scope of protection of this invention.

[0125] Please continue to refer to Figures 1 and 25-28. In order to ensure the stability of the tissue clamping device during the opening process and the support strength of the clamping arm, in the preferred embodiment, the width of the first segment 11 along the extension direction gradually decreases and then gradually increases, so that the first segment 11 is wide at both ends and narrow in the middle. This results in a larger width at the distal and proximal ends of the first segment 11 and a narrower width in the middle. This ensures good support at both ends of the support arm, while the narrow part in the middle is preferentially bent and deformed to reduce the force accumulation. Of course, in order to further improve the support and bending performance in the middle, as shown in Figure 28, the two sides of the first segment 11 in the width direction gradually concave inward along the extension direction, approaching its longitudinal axis aa and then gradually moving away from the axis aa (the axis aa is the axis of the extension direction of the support arm 52). This method can make the width of the two ends of the first segment 11 as large as possible and the width in the middle as small as possible during the width change process, which improves the support at both ends and enhances the deformation capacity in the middle. In addition, the concave method along both sides also reduces the process and cost, and the effective support width is set as centrally as possible, so that it can also form a support centered in the extension direction during its deformation process, avoiding force accumulation while maintaining good support.

[0126] Preferably, the minimum width W0 of the first segment of the present invention is between 1 / 3 and 2 / 3 of the preset extension length of the support arm 52. For example, as shown in FIG28, the distance from the minimum width W0 of the first segment 11 to the far end of the support arm 52 is Lw, and the preset extension length of the support arm 52 is L, then Lw = (1 / 3 to 2 / 3) * L. This position ensures that the minimum width W0 of the first segment 11 is as close as possible to the middle of the support arm 52, avoiding the narrowest point being at the two ends of the support, thus ensuring the support arm's own support while improving the deformation in the middle and preventing force accumulation leading to bouncing. The minimum width of the first segment 11 is 0.1mm to 1mm smaller than the overall maximum width of the support arm 52. Preferably, the minimum width W0 of the first segment 11 is 0.2mm to 0.5mm smaller than the overall maximum width of the support arm 52. This width avoids the narrowest point being too narrow, resulting in insufficient support or breakage, while also forming an effective buffer transition to prevent force accumulation and bouncing.

[0127] For example, as shown in Figures 1 and 25-28, the support arm 52 of the present invention further includes a second segment 12 having a second extension length L2 and a third segment 13 having a third extension length L3. The second segment 12 and the third segment 13 are respectively connected to the distal end and the proximal end of the first segment 11, that is, the second segment 12 and the third segment 13 are located on the distal side and the proximal side of the first segment 11, respectively. The widths of both the second segment 12 and the third segment 13 are greater than the minimum width W0 of the first segment 11. The width of the second segment 12 along its length direction can be uniform or non-uniform, or it can be gradient or non-gradient. Preferably, the width of the second segment 12 is uniform, and the width of the second segment 12 is greater than the minimum width W0 of the first segment 11. The proximal end of the second segment 12 is transitionally connected to the distal end of the first segment 11. The width of the third segment 13 along its length can be uniform or non-uniform, and can be gradient or non-gradual. The width of the third segment 13 is greater than the minimum width W0 of the first segment 11. Preferably, as shown in Figure 28, the third segment 13 can gradually bulge outward from the proximal end of the first segment 11, then bend inward and extend proximally, forming a widened section within the third segment. Alternatively, the third segment 13 can gradually bulge outward from the proximal end of the first segment 11, then extend longitudinally straight for a period, then bend inward and extend proximally, forming a small widened section within the third segment 13. Understandably, the maximum width W3 of the widened third segment 13 is greater than the maximum width W2 of the second segment 12. In this embodiment, the widened section or small widened section formed at the third segment 13 enhances the proximal support performance of the support arm, providing strong support when the support arm expands outward and preventing problems such as breakage at the support position. It is understandable that when there are a first segment 11, a second segment 12, and a third segment 13, the preset extension length L is equal to the sum of the first extension length L1 of the first segment 11, the second extension length L2 of the second segment 12, and the third extension length L3 of the third segment 13, that is, L = L1 + L2 + L3. Regardless of whether the width of the second segment 12 and the third segment 13 changes or does not change, the width of the second segment 12 and the third segment 13 is greater than the minimum width W0 of the first segment 11 whose width gradually changes.

[0128] Referring again to Figures 1 and 25-28, the support arm 52 further includes a distal connecting segment 14 and a proximal connecting segment 15, respectively connected to the distal end of the second segment 12 and the proximal end of the third segment 13. The distal connecting segment 14 has a fourth extension length L4, and the proximal connecting segment 15 has a fifth extension length L5. The distal connecting segment 14 and the proximal connecting segment 15 are set to be of substantially equal width, and their widths are smaller than the widths of the adjacent second segment 12 and third segment 13, respectively. During assembly, the connection is achieved by assembling with other components through the connecting segments at both ends (i.e., the distal connecting segment 14 and the proximal connecting segment 15). It should be noted that the term "substantially equal width" in this embodiment refers to the allowable error caused by equipment or manual operation during the manufacturing process. The width difference between the two is considered to be substantially equal width if it is within the range of 0mm to 2mm. Understandably, when there are a first segment 11, a second segment 12, a third segment 13, a distal connecting segment 14, and a proximal connecting segment 15, the preset extension length L is equal to the sum of the first extension length L1 of the first segment 11, the second extension length L2 of the second segment 12, the third extension length L3 of the third segment 13, the fourth extension length L4 of the distal connecting segment 14, and the fifth extension length L5 of the proximal connecting segment 15, i.e., L = L1 + L2 + L3 + L4 + L5. Regardless of whether the width of the second segment 12, the third segment 13, the distal connecting segment 14, and the proximal connecting segment 15 changes or does not change, the width of the second segment 12, the third segment 13, the distal connecting segment 14, and the proximal connecting segment 15 is greater than the minimum width W0 on the first segment 11, whose width gradually changes.

[0129] Referring to Figures 25 and 29, the segments on the proximal side of the distal connecting segment 14 are offset outward relative to the distal connecting segment 14 and are in an arc shape. That is, the distal connecting segment 14 of the support arm 52 is vertically arranged relative to the longitudinal direction, while the other segments on the distal side of the distal connecting segment 14 are offset outward relative to the distal connecting segment 14. In other words, the other segments of the support arm 52, except for the distal connecting segment 14, are all outwardly expanded. The angle of the outward offset of the other segments is α, 10°≤α≤25°. During assembly, the arc shape of the support arm 52 conforms to the bending direction of the distal segment of the clamping arm 53 and expands outward. In this embodiment, the support arm 52 has a gradually changing width and a pre-shaped bending structure design to achieve pre-opening deformation when the tissue clamping device is opened, reduce the opening force and reduce the force storage effect, and at the same time, it can achieve a flexible and smooth opening process of the tissue clamping device. The support arm 52 of the present invention can be an integral structure made of metal wire or sheet, which has a corresponding bending shape after heat setting treatment to form each segment.

[0130] The fixed connection method or relatively fixed method of the present invention can be adopted by means mastered by those skilled in the art, including but not limited to welding, gluing, crimping, metal wire sewing, etc.

[0131] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of the claims of the present invention.

Claims

1. A tissue clamping device, characterized in that, include: A support member having a longitudinal central axis; A spacer is sleeved on the support member, the spacer having a proximal end opening and a distal end opening, the support member passing through the proximal end opening and the distal end opening; A connecting seat and a supporting seat are provided, wherein the connecting seat is fixed relative to the proximal end of the supporting member, and the supporting seat is fixed relative to the distal end of the supporting member. The two ends of the spacer are located between the connecting seat and the supporting seat, and the diameters of the proximal end and the distal end are respectively smaller than the maximum radial outer diameters of the connecting seat and the supporting seat. A pair of clamping components, the pair of clamping components being disposed opposite each other on both sides of the spacer and being openable or closed relative to the central axis.

2. The tissue clamping device according to claim 1, characterized in that, It also includes a proximal fixing ring, which is sleeved on the support and fixedly connected to the proximal end. The proximal fixing ring and the proximal end are fixedly or movably sleeved on the support.

3. The tissue clamping device according to claim 2, characterized in that, The proximal retaining ring and the proximal constriction are at least partially nested with the connecting seat in the axial direction; the distal side of the connecting seat is recessed with a distal groove, the connecting seat is sleeved on the proximal end of the support member, and the proximal end of the support member and at least a portion of the proximal retaining ring and the proximal constriction are received in the distal groove, the connecting seat is fixedly connected to the proximal retaining ring or the connecting seat is fixedly connected to the support rod.

4. The tissue clamping device according to claim 2, characterized in that, The proximal fixing ring and the connecting seat are axially opposite to each other; the distal side of the connecting seat is recessed with a distal groove, the connecting seat is sleeved on the proximal end of the support member and the proximal end of the support member is received in the distal groove, and the connecting seat and the support member are fixedly connected.

5. The tissue clamping device according to claim 1, characterized in that, The support base has an axial through hole that extends through the support base. The support base is sleeved on the outside of the support member through the through hole and is fixed relative to the support member.

6. The tissue clamping device according to claim 5, characterized in that, The support base is sleeved on the distal end of the support member through the through hole, and the support base, the distal end, and the support member are relatively fixed.

7. The tissue clamping device according to claim 5, characterized in that, It also includes a distal fixing ring, which is sleeved on the outside of the support member and fixedly connected to the distal end. The distal fixing ring and the distal end are fixedly or movably sleeved on the support member.

8. The tissue clamping device according to claim 7, characterized in that, The proximal side of the support base is recessed with a proximal groove that communicates with the through hole; the distal fixing ring and the distal constriction are fixedly connected and housed in the proximal groove.

9. The tissue clamping device according to claim 1, characterized in that, The spacer is made of a first material, and the support and / or the connecting seat and / or the support seat is made of a second material different from the first material.

10. The tissue clamping device according to claim 1, characterized in that, The surface of the spacer opposite to the clamping assembly is a first arc surface that is concave towards the central axis. In its unconstrained natural state, the radial distance between the two first arc surfaces gradually increases from far to near.

11. The tissue clamping device according to claim 10, characterized in that, There is a maximum distance between the two first arc surfaces that gradually increase in size from far to near; Each of the clamping components includes a clamping portion and a resilient hook-holding portion. One hook-holding portion is positioned between the spacer and the clamping portion. The clamping portion and the hook-holding portion cooperate to clamp tissue. The two resilient hook-holding portions are spaced apart from each other, such that one hook-holding portion is close to the clamping portion. When a pair of clamping portions are closed, the maximum radial distance between the two hook-holding portions is less than the maximum spacing.

12. The tissue clamping device according to claim 11, characterized in that, A pair of hook clamping parts are connected by a hook fixing part. The support includes a base and a connecting tube located at the distal end of the base. The two sides of the root of the connecting tube extend radially to form protrusions. The hook fixing part is provided with a connecting hole through which the connecting tube can pass. The two sides of the connecting hole form notches radially to fit and engage with the protrusions.

13. The tissue clamping device according to claim 12, characterized in that, It also includes an anchoring ring, the outer diameter of which is larger than the minimum diameter of the connecting hole. The anchoring ring is sleeved on the connecting tube at the distal end of the hook fixing part and is fixed relative to the connecting tube. The hook fixing part is confined between the base and the anchoring ring.

14. The tissue clamping device according to claim 12, characterized in that, The two sides of the seat body, near the center, bulge outward in an arc shape along the width direction.

15. The tissue clamping device according to claim 11, characterized in that, The hook clamping part is a single-arm structure, which includes a first part near the central axis and a second part connected to the first part; in the unconstrained natural state, the angles between the first part and the second part and their axis of symmetry are α1 and α2, respectively, where α1 is less than α2.

16. The tissue clamping device according to claim 15, characterized in that, The difference between α1 and α2 is between 1 degree and 10 degrees.

17. The tissue clamping device according to any one of claims 1 to 16, characterized in that, The axial distance between the proximal end and the distal end is less than the maximum axial height of the spacer.

18. The tissue clamping device according to claim 17, characterized in that, At least the proximal end opening is located on the distal side of the proximal top of the spacer, and the circumferential surface between the proximal top of the spacer and the proximal end opening forms a recessed cavity, with at least the distal portion of the connector placed within the recessed cavity.

19. A clamping system, characterized in that, Includes the tissue clamping device and delivery assembly as described in any one of claims 1 to 18, wherein the delivery assembly is detachably connected to the tissue clamping device.

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