Clamping system, clamper and pusher

Abstract

This invention discloses a clamping system, a clamping device, and a pusher. The clamping system includes a clamping device and a pusher. The clamping device includes a guide tube, a mounting base, a release seat, and a clamping assembly. The mounting base is fixed to the proximal end of the guide tube, and the distal end of the guide tube is axially slidably connected to the release seat. The clamping assembly includes an openable and closable clamping part. The pusher includes a push handle, a push sheath, a push shaft, and a drive module. The drive module is connected to the push handle. The proximal end of the push sheath is fixed relative to the push handle. The distal end of the push sheath is fixed to a hook seat. The push shaft is movably placed inside the push sheath. The proximal end of the push shaft is connected to the drive module. The distal end of the push shaft passes through the hook seat, through the mounting base and the guide tube, and is detachably connected to the release seat. The radial distances between the walls of the smallest central holes on the mounting base and the hook seat through which the push shaft can pass and the push shaft are W1 and W2, respectively, where W1 and W2 are both in the range of 0.001 mm to 0.03 mm.

Description

Technical Field

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

[0002] Mitral valve disease is a common condition among the elderly, including two common types: mitral regurgitation and mitral stenosis, with mitral regurgitation being the most prevalent. Statistics show that the incidence of mitral regurgitation in people over 75 years of age is as high as 10%. Mild mitral regurgitation generally does not affect daily life, while moderate to severe mitral regurgitation requires intervention. Traditional surgical treatment involves open-heart surgery, where the heart is opened under cardiopulmonary bypass to repair or replace the valves. However, high-risk patients cannot tolerate this procedure. In recent years, interventional therapy has emerged, offering hope to high-risk patients with mitral regurgitation. Interventional therapy typically involves delivering instruments to the affected area via catheter to repair or replace the valve.

[0003] Currently, most transcatheter mitral valve replacement products are in the clinical research stage. Transcatheter mitral valve repair products already on the market include MitraClip from Abbott Laboratories and Pascal from Edwards Laboratories. Both work by using a clamping device to clamp the anterior and posterior leaflets of the mitral valve, reducing the valve opening area and thus treating regurgitation. MitraClip uses a mechanically locking clamping device, which requires unlocking during intervention to perform the clamping operation. This makes the procedure complex, and the clamping stress, being mechanically locked, is uncontrollable, leading to significant leaflet damage. Pascal overcomes this drawback of MitraClip by using an elastic clamping method. The leaflets are clamped between an elastic clamping arm and a flexible spacer, mitigating clamping stress and reducing leaflet damage. Furthermore, because it uses an elastic clamping arm, the clamping force is provided by the arm's elasticity, eliminating the need for a mechanical locking mechanism. This results in a simpler product design and easier operation. However, for clamping methods that achieve clamping through elastic self-locking, the opening process requires the support arm to open the clamping arm, and this support opening process requires a large force. Therefore, ensuring the connection stability of the entire clamping system under such large forces is crucial. Summary of the Invention

[0004] Based on this, the present invention proposes a clamping system, a clamper, and a pusher, aiming to improve the connection stability of the clamping system.

[0005] To achieve this objective, the present invention adopts the following technical solution:

[0006] This invention provides a clamping system, including a clamp and a pusher detachably connected to the clamp;

[0007] The clamping device includes a guide tube, a mounting base, a release seat, and a clamping assembly. The mounting base is fixed to the proximal end of the guide tube, and the distal end of the guide tube is axially slidably connected to the release seat. The clamping assembly includes at least two clamping portions located on the outside of the guide tube. One end of each clamping portion is pivotally connected to the guide tube to form a pivot position, and the other end is fixedly connected to the release seat to form a fixed position. The clamping portion can open and close during the change of the axial distance between the pivot position and the fixed position.

[0008] The pusher includes a push handle, a push sheath, a push shaft, and a drive module. The drive module is connected to the push handle. The proximal end of the push sheath extends into the push handle and is fixed relative to it. The distal end of the push sheath is fixed to a hook seat, which is detachably connected to the mounting base. The push shaft is movably placed inside the push sheath, and the proximal end of the push shaft is connected to the drive module via the push handle. The distal end of the push shaft can be detachably connected to the release seat after passing through the hook seat, the mounting base, and the guide tube in sequence.

[0009] The push shaft can drive the release seat to move axially relative to the guide tube under the drive of the drive module, thereby changing the axial distance between the pivot position and the fixed position of the clamping part.

[0010] The radial distances between the wall of the smallest central hole on the mounting base and the hook base through which the push shaft can pass and the push shaft are W1 and W2, respectively, and the range of W1 and W2 is 0.001 mm to 0.03 mm.

[0011] In one embodiment, the mounting base includes an axially connected mounting base fixing part and a mounting base connecting part disposed on the proximal side of the mounting base fixing part. The mounting base fixing part is fixedly connected to the proximal end of the guide tube, and the mounting base connecting part is used for detachable connection with the claw seat. The mounting base fixing part is provided with a first mounting base center hole, and the mounting base connecting part is provided with a second mounting base center hole. The first mounting base center hole and the second mounting base center hole communicate with each other to allow the push shaft to pass through. The second mounting base center hole is the smallest center hole on the mounting base that allows the push shaft to pass through.

[0012] The hook holder includes a base body, which includes an axially connected hook fixing part and a hook connecting part located at the distal end of the hook fixing part. The hook fixing part is fixedly connected to the distal end of the push sheath tube, and the hook connecting part is used for detachable connection with the hanging platform. The hook fixing part is provided with a first hook center hole, and the hook connecting part is provided with a second hook center hole. The first hook center hole and the second hook center hole are connected to allow the push shaft to pass through. The second hook center hole is the smallest center hole on the hook holder that allows the push shaft to pass through.

[0013] In one embodiment, the diameter of the central hole of the first hook is larger than the diameter of the central hole of the second hook. The distal end of the push sheath extends into the central hole of the first hook and is fixedly connected to the hook fixing part. The radial distance between the push shaft extending from the hook seat at the distal end of the push sheath and the push sheath is W3, and W3 is greater than W2.

[0014] In one embodiment, the mounting bracket connecting portion includes a first connecting portion coaxially disposed with the mounting bracket fixing portion and a hook mounting bracket disposed on the first connecting portion. A partial axial projection of the first connecting portion in the circumferential direction overlaps with the projection of the mounting bracket fixing portion, and the axial projection of other portions of the first connecting portion in the circumferential direction is located within the projection of the mounting bracket fixing portion. The hook mounting bracket is formed by extending in an arc shape in the circumferential direction from a partial position of the first connecting portion. The proximal end face of the hook mounting bracket is flush with the proximal end face of the first connecting portion, and the distal end face of the hook mounting bracket is opposite to the proximal end face of the mounting bracket fixing portion and there is a gap groove between them.

[0015] The hook connection portion includes a second connection portion located at the proximal end and a hook portion located at the distal end. The hook portion includes a C-shaped hook platform located at the distal end and a C-shaped groove located between the C-shaped hook platform and the second connection portion. The C-shaped hook platform and the C-shaped groove are radially opposite to each other and partially overlap.

[0016] When the mounting bracket connecting part of the mounting bracket and the hook claw connecting part of the hook claw base are detachably connected, the mounting bracket connecting part and the hook claw connecting part are axially opposite each other, the hook mounting bracket extends into the C-shaped groove, the C-shaped hook claw is placed in the spacer groove, and the proximal end face of the hook mounting bracket and the distal end face of the C-shaped hook claw are abutted against each other to form an axial limit.

[0017] In one embodiment, when the push shaft passes through the hook seat and the mounting base and the hook seat is at its maximum radial offset relative to the mounting base, the proximal end face of the hook mounting base and the distal end face of the C-shaped hook seat are still in surface contact.

[0018] In one embodiment, the outer peripheral surface of the first connecting part at the interval groove is a plane, and the inner walls of both sides of the C-shaped claw platform are planes. When the hanging platform connecting part and the claw connecting part are detachably connected, the first connecting part at the interval groove and the C-shaped claw platform are two planes facing each other.

[0019] In one embodiment, the hook seat further includes an end cap extending radially outward from the outer periphery of the seat body. The end cap has through holes through which an adjustment line can pass. There are multiple through holes, which are spaced apart circumferentially along the end cap.

[0020] In one embodiment, the outer wall of the hook fixing part is provided with a plurality of protrusions, the plurality of protrusions are spaced apart along the outer periphery of the hook fixing part, and a recess is formed between each pair of adjacent protrusions. When the push sheath is connected to the hook fixing part, the inner tube of the push sheath extends into the central hole of the first hook and is fixedly connected to the hook fixing part, and the outer tube of the push sheath is sleeved on the hook fixing part and fixedly connected to the hook fixing part, wherein a portion of the outer tube extends into the recess.

[0021] The present invention also provides a clamp for clamping tissue, comprising a guide tube, a mounting base, a release seat, and a clamping assembly. The mounting base is fixed to the proximal end of the guide tube, and the distal end of the guide tube is axially slidably connected to the release seat. The clamping assembly includes at least two clamping portions disposed on the outside of the guide tube. One end of each clamping portion is pivotally connected to the guide tube to form a pivot position, and the other end is fixedly connected to the release seat to form a fixed position. Under the action of external force, the release seat and the guide tube can move axially, thereby changing the axial distance between the pivot position and the fixed position of the clamping portion, thereby realizing the opening and closing of the clamp. The radial distance between the wall of the smallest central hole on the mounting base through which the pusher shaft passes and the pusher shaft is W1, wherein W1 ranges from 0.001 mm to 0.03 mm.

[0022] In one embodiment, the mounting base includes an axially connected mounting base fixing part and a mounting base connecting part disposed on the proximal side of the mounting base fixing part. The mounting base fixing part is fixedly connected to the proximal end of the guide tube, and the mounting base connecting part is used for detachable connection with the hook base of the pusher.

[0023] The mounting bracket connecting part includes a first connecting part coaxially arranged with the mounting bracket fixing part and a hook platform disposed on the first connecting part. A partial axial projection of the first connecting part in the circumferential direction overlaps with the projection of the mounting bracket fixing part, and the axial projection of other parts of the first connecting part in the circumferential direction is located within the projection of the mounting bracket fixing part. The hook platform is formed by extending in an arc shape in the circumferential direction from a local position of the first connecting part. The proximal end face of the hook platform is flush with the proximal end face of the first connecting part, and the distal end face of the hook platform is opposite to the proximal end face of the mounting bracket fixing part and there is a gap groove between them.

[0024] When the mounting platform connecting part of the mounting base and the hook claw connecting part of the pusher are detachably connected, the mounting platform connecting part and the hook claw connecting part are axially opposite each other, the hook platform extends into the C-shaped groove of the hook claw connecting part, the C-shaped hook claw platform of the hook claw connecting part is placed in the spacer groove, and the proximal end face of the hook platform and the distal end face of the C-shaped hook claw platform of the hook claw connecting part abut against each other and form an axial limit between them.

[0025] In one embodiment, the outer peripheral surface of the first connecting part at the interval groove is a plane. When the hanging platform connecting part and the hook connecting part of the pusher are detachably connected, the first connecting part at the interval groove and the C-shaped hook platform of the hook connecting part are two planes facing each other.

[0026] The present invention also provides a pusher for pushing a clamp, the pusher including a push handle, a push sheath, a push shaft and a drive module; the drive module is connected to the push handle, the proximal end of the push sheath extends into the push handle and is fixed relative to the push handle, the distal end of the push sheath is fixedly provided with a hook seat, the hook seat is used for detachable connection with the clamp's mounting base; the push shaft is movably placed in the push sheath, and the proximal end of the push shaft is connected to the drive module via the push handle, the distal end of the push shaft can pass through the hook seat and through the clamp's mounting base and guide tube and then be detachably connected to the clamp's release seat;

[0027] The push shaft can drive the release seat to move relative to the guide tube under the drive of the drive module, thereby realizing the opening and closing of the clamp;

[0028] The radial distance between the wall of the smallest central hole on the claw seat through which the push shaft can pass and the push shaft is W2, and the range of W2 is 0.001 mm to 0.03 mm.

[0029] In one embodiment, the hook seat includes a base body, the base body including an axially connected hook fixing part and a hook connecting part located at the distal end of the hook fixing part, the hook fixing part being fixedly connected to the distal end of the push sheath, and the hook connecting part being detachably connected to the clamping device's mounting base; wherein...

[0030] The hook connection portion includes a second connection portion located at the proximal end and a hook portion located at the distal end. The hook portion includes a C-shaped hook platform located at the distal end and a C-shaped groove located between the C-shaped hook platform and the second connection portion. The C-shaped hook platform and the C-shaped groove are radially opposite to each other.

[0031] When the mounting plate connecting part of the clamp is detachably connected to the hook connecting part of the hook base, the mounting plate connecting part and the hook connecting part are axially opposite each other, the hook plate of the mounting plate connecting part extends into the C-shaped groove, the C-shaped hook plate is placed in the spacer groove of the mounting plate connecting part, and the proximal end face of the hook plate and the distal end face of the C-shaped hook plate abut against each other to form an axial limit.

[0032] In one embodiment, the inner walls of both sides of the C-shaped claw platform are flat. When the hanging platform connecting part of the clamping device is detachably connected to the claw connecting part, the first connecting part at the interval groove of the clamping device and the C-shaped claw platform are two planes facing each other.

[0033] The clamping system, clamper, and pusher of this invention, by limiting the radial distance between the wall of the minimum central hole on the mounting base and the claw base through which the push shaft can pass and the push shaft, effectively constrain the push shaft passing through at the connection point, improving the rigidity of the push shaft at the connection point and ensuring the engagement and connection stability of the clamper and pusher in the clamping system. Simultaneously, the axial length of the mounting base and the claw base can be minimized, maximizing the clamping area while minimizing the clamper's design. Furthermore, when the push shaft passes through the claw base and the mounting base and the claw base is at its maximum radial offset relative to the mounting base, the proximal end face of the hook-hanging platform and the distal end face of the C-shaped claw platform remain in surface contact. This method ensures both stable and effective opening and closing of the clamper and easy release of the clamper's connection and release mechanism. Furthermore, when the mounting base and the claw base are detachably connected, the first connecting part at the interval groove of the mounting base and the C-shaped claw base of the claw base are two planes facing each other. The contact torque between the two planes increases the contact torque between them, ensuring the torsional synchronization of the clamping system, so that the torsional action at the proximal end can be quickly transmitted to the distal end and a rapid response can be obtained. Attached Figure Description

[0034] Figure 1 This is a partial schematic diagram illustrating the connection of the clamp and pusher, which are exemplary embodiments of the present invention.

[0035] Figure 2 This is a partial schematic diagram illustrating the separation of the clamp and pusher, which are exemplary embodiments of the present invention.

[0036] Figure 3 This is a partial schematic diagram of the clamping device in an exemplary clamping system of the present invention when it is closed;

[0037] Figure 4 This is a partial schematic diagram of the clamping device in an exemplary clamping system of the present invention when it is open;

[0038] Figure 5 This is a schematic diagram of an exemplary clamp of the present invention;

[0039] Figure 6 This is a partial cross-sectional schematic diagram illustrating the connection of the clamp and pusher, which are exemplary embodiments of the present invention.

[0040] Figure 7 This is a schematic diagram of the hanging platform in an exemplary clamp of the present invention, wherein, Figure 7 (a) is a three-dimensional schematic diagram of the mounting base, and (b) is a half-section schematic diagram of the mounting base;

[0041] Figure 8 This is a schematic diagram of the hook base in an exemplary pusher of the present invention, wherein, Figure 8 (a) is a three-dimensional schematic diagram of the hook seat, and (b) is a half-section schematic diagram of the hook seat;

[0042] Figure 9 This is a schematic diagram of the push axis in an exemplary pusher of the present invention;

[0043] Figure 10 This is a perspective view of the hanging platform in the clamp of the present invention from another angle;

[0044] Figure 11 This is a schematic diagram of the hanging platform, hook seat, and push shaft in an exemplary clamping system of the present invention, wherein, Figure 11 (a) is a schematic diagram before the mounting base, hook seat and push shaft are connected, and (b) is a schematic diagram after the mounting base, hook seat and push shaft are connected.

[0045] Figure 12 This is a schematic diagram of a push shaft passing through a connected mounting bracket and a hook bracket in an exemplary clamping system of the present invention.

[0046] Figure 13 (a) is a schematic diagram of the push shaft passing through the mounting base and hook base in the exemplary clamping system of the present invention, and (b) is a cross-sectional view at point XX in (a).

[0047] Figure 14 This is a schematic diagram of an exemplary clamping system of the present invention, including an adjustable bending sheath and a loading sheath. Detailed Implementation

[0048] To make the objectives, technical solutions, and advantages of this invention clearer, exemplary embodiments of this disclosure will now be described in more detail with reference to the accompanying drawings. While exemplary embodiments of this disclosure are shown in the drawings, it should be understood that this disclosure can be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided to enable a more thorough understanding of this disclosure and to fully convey the scope of this disclosure to those skilled in the art.

[0049] It should be understood that the terminology used herein is for the purpose of describing particular exemplary embodiments only and is not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “described” as used herein may also include the plural forms. The terms “comprising,” “including,” “containing,” and “having” are inclusive and therefore indicate the presence of the stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or combinations thereof. The method steps, processes, and operations described herein are not construed as requiring them to be performed in a particular order described or illustrated unless the order of performance is explicitly indicated. It should also be understood that additional or alternative steps may be used.

[0050] Although terms such as first, second, third, etc., may be used in this document to describe multiple elements, components, regions, layers, and / or segments, these elements, components, regions, layers, and / or segments should not be limited by these terms. These terms may be used only to distinguish one element, component, region, layer, or segment from another. Unless the context clearly indicates otherwise, terms such as "first," "second," and other numerical terms used herein do not imply order or sequence. Therefore, the first element, component, region, layer, or segment discussed below may be referred to as the second element, component, region, layer, or segment without departing from the teachings of the exemplary embodiments.

[0051] For ease of description, spatial relative terms may be used in the text to describe the relationship of one element or feature relative to another element or feature, as shown in the figure. These relative terms include, for example, "inside," "outside," "middle," "outer," "below," "below," "above," "over," etc. Such spatial relative terms are intended to include different orientations of the device in use or operation, other than those depicted in the figure. For example, if the device in the figure is flipped, an element described as "below other elements or features" or "below other elements or features" would subsequently be oriented as "above other elements or features" or "above other elements or features." Therefore, the example term "below" can include both upper and lower orientations. The device may be otherwise oriented (rotated 90 degrees or in other directions), and the spatial relative descriptors used in the text will be interpreted accordingly.

[0052] Additionally, it should be noted that in the field of interventional medical devices, the end of a medical device implanted in the human or animal body, or the delivery device used to transport the device, closer to the operator is generally referred to as the "proximal end," and the end farther from the operator is referred to as the "distal end." Based on this principle, the "proximal end" and "distal end" of any component of a medical device or delivery device are defined. "Axial direction" generally refers to the length of the medical device during transport, and "radial direction" generally refers to the direction perpendicular to the "axial direction" of the medical device. Based on this principle, the "axial direction" and "radial direction" of any component of a medical device are defined.

[0053] Example 1

[0054] Because the surgical approach for the clipping system involves puncturing the interatrial septum via the femoral vein, and the space in the left atrium and left ventricle is limited, while the clip needs to bend, open, move, and capture within it, therefore, to meet the needs of patients, please refer to [the relevant documentation / reference]. Figure 1 and Figure 2 As shown, the overall hard end dimension L from the head of the clamp 10 to the sheath fixation position must be minimized. However, it is also necessary to maximize the capture area of ​​the clamp 10 and ensure that it can operate within a certain size space inside the heart. Therefore, the connection structure dimension L1 between the clamp 10 and the pusher 20 in the clamping system must be designed to be minimized. This requires minimizing the L2 and L3 at their respective connections. However, minimizing the design of L2 and L3 can easily lead to unstable engagement and reduced connection stability.

[0055] Furthermore, since the clamp 10 needs to be adjusted and its position changed during surgery, the rigidity of the entire delivery system sheath needs to be reduced to ensure flexibility. Therefore, the distal end of the push shaft 23 that controls the opening and closing of the clamp 10 is generally made of a flexible material, such as nickel-titanium wire or ground stainless steel wire. The clamp 10 is an elastic self-locking flexible symmetrical clamp. The initial opening force is relatively large, and it is necessary to ensure that the forces on both sides of the clamp 10 are balanced and that no large lateral deformation occurs; otherwise, the clamp 10 will not be able to open.

[0056] Based on the above considerations, this embodiment proposes a clamping system that is stable in engagement and not prone to lateral deformation, while pursuing the minimum design of L2 and L3.

[0057] See Figures 1-4 The clamping system 100 of this embodiment includes a clamper 10 and a pusher 20 detachably connected to the clamper 10. The clamper 10 is a valve repair implant, which mainly uses a clamping assembly 14 to capture and clamp the valve leaflets, thereby reducing the degree of regurgitation. The pusher 20 is mainly used to push, open, capture, close, retrieve, and release the clamper 10. Figure 3 The image shows the clamp 10 in an unopened state when it is connected to the pusher 20. Figure 4 This demonstrates the open state of the clamp 10 when it is connected to the pusher 20. (Continue to refer to...) Figure 4 and Figure 5 When the clamp 10 enters the left atrium, the moving component 242 moves axially by rotating the drive knob 241, thereby driving the push shaft 23 connected to it to move, which in turn opens the clamping arm 1411 and the support arm 1412 in the clamping part 141. The opening angle of the left and right support arms 1412 is about 60° to 150°. At this time, the clamp 10 can be sent into the left ventricle and then retreated into the valve waiting capture area.

[0058] For details, see Figure 5 As shown, the clamping device 10 includes a guide tube 11, a mounting base 12, a release seat 13, and a clamping assembly 14. The mounting base 12 is fixed to the proximal end of the guide tube 11, and the distal end of the guide tube 11 is axially slidably connected to the release seat 13. The clamping assembly 14 includes at least a clamping portion 141 disposed on the outside of the guide tube 11. For example, two clamping portions 141 are symmetrically arranged relative to the guide tube 11. One end of each clamping portion 141 is pivotally connected to the guide tube 11 to form a pivot position 17, and the other end is fixedly connected to the release seat 13 to form a fixed position 18. The clamping portion 141 can open and close during the change of the axial distance between the pivot position 17 and the fixed position 18.

[0059] Reference Figure 5As shown, in other embodiments, the clamping device 10 further includes a spacer 15, which is a cage-like structure fitted onto the guide tube 11 and fixed to the guide tube 11 after its two ends are constricted. In this embodiment, the spacer 15 is a deformable cage-like structure woven from elastic metal wire, and its surface can be covered with a polymer film, such as PET cloth or PTFE film. After the clamping device 10 clamps the leaflets, the spacer 15 serves as a sealing and filling function, and its deformability also helps to reduce stress during leaflet clamping.

[0060] Continue to refer to Figure 5 As shown, in other embodiments, the clamp 10 further includes a fixing seat 16, which is fixed to the guide tube 11 near its distal end. The clamping portion 141 is pivotally connected to the fixing seat 16, forming a pivot position 17 at the pivot point. For example, as... Figure 5 As shown, the clamping part 141 includes a clamping arm 1411 and a supporting arm 1412. One end of the clamping arm 1411 is fixedly connected to the release seat 13, and the other end is pivotally connected to the supporting arm 1412. The other end of the supporting arm 1412 is pivotally connected to the fixed seat 16 to form a pivot position 17. The supporting arm 1412 and the clamping arm 1412 are rotatably connected. The clamping arm 1411 can be made of a highly elastic metal material, such as nickel-titanium wire, to provide clamping force when the clamping device 10 clamps. The supporting arm 1412 can be made of a metal or polymer material with certain rigidity and toughness to provide the function of opening the clamping arm 1411.

[0061] Continue to refer to Figure 5 As shown, in other embodiments, the clamping assembly 14 further includes hooks 142, two hooks 142 are symmetrically arranged, one end of the hook 142 is fixed to the distal end of the guide tube 11, and the other end is a free end. The hooks 142 are located between the guide tube 11 and the clamping part 141. When the spacer 15 is present, the hooks 142 are located between the spacer 15 and the clamping part 141. Exemplarily, as a way to fix the hooks 142 to the guide tube 11, when the fixing seat 16 is present, the two hooks 142 can be integrally formed, and the middle connecting part is fixed to the fixing seat 16. The hooks 142 are provided with barbs (not shown), and the barbs are opposite to the clamping part 141. The hook 142 can be made of a highly elastic metal material. When the free end of the hook 142 is pulled up, the hook 142 fits against the spacer 15 and forms a certain angle with the support arm 1412. When the free end of the hook 142 is released, the hook's own elasticity causes it to approach and fit against the support arm 1412 on the corresponding side, which is used to capture the leaflet during surgery.

[0062] Continue to refer to Figures 2-4As shown, the pusher 20 includes a push handle 21, a push sheath 22, a push shaft 23, and a drive module 24. The drive module 24 is connected to the proximal end of the push handle 21. The proximal end of the push sheath 22 extends into the push handle 21 and is fixed relative to the push handle 21. The distal end of the push sheath 22 is fixedly connected to a hook seat 221, which is used for detachable connection with the mounting base 12. The push shaft 23 is movably placed inside the push sheath 22, and the proximal end of the push shaft 23 passes through the push handle 21 and is connected to the drive module 24 located at the proximal end of the push handle 21. The distal end of the push shaft 23 can pass out from the hook seat 221 at the distal end of the push sheath 22 and pass through the mounting base 12 and the guide tube 11 to be detachably connected to the release seat 13. Driven by the drive module 24, the push shaft 23 can cause the release seat 13, which is detachably connected to it, to move axially relative to the guide tube 11. This movement changes the axial distance between the pivot position 17 and the fixed position 18 of the clamping part 141. The change in the axial distance between the pivot position 17 and the fixed position 18 enables the clamping part 141 to open and close.

[0063] Reference Figure 4 As shown, exemplarily, the drive module 24 includes a drive knob 241 and a moving component 242; rotating the drive knob 241 causes the moving component 242 to move linearly back and forth, controlling the opening, straightening, and closing of the coupling. The moving component 242 includes a threaded drive post 2421, a safety key 2422, and a release component 2423. The threaded drive post 2421 is threadedly engaged with the drive knob 241; the safety key 2422 is a safety switch key for the release component 2423, allowing the release component 2423 to be fixed and separated from the threaded drive post 2421; when the release component 2423 is separated from the threaded drive post 2421, rotating the release component 2423 disengages the distal thread of the push shaft 23 from the threaded release seat, and then pulling out the release component 2423 disengages the push shaft 23 from the clamp 10, achieving the effect of releasing the clamp 10.

[0064] Continue to refer to Figure 4 As shown, the pusher 20 also includes a push-pull rod module 25, which is used to control the adjustment line, which is connected to the free end of the hook 142.

[0065] Among them, such as Figure 6 As shown, the radial distances between the wall of the minimum center hole on the mounting base 12 and the hook base 221 through which the push shaft 23 can pass and the push shaft 23 are W1 and W2, respectively, and the range of W1 and W2 is 0.001 to 0.03 mm. Figures 6-9In the diagram, A is the axial force-bearing surface when the mounting base 12 and the claw base 221 are engaged. When the clamping device 10 is opened, the engagement surface needs to withstand a large force and ensure the stability of the engagement. D1 and D2 are the minimum center through holes of the mounting base 12 and the claw seat 221 through which the push shaft 23 can pass, respectively. L4 and L5 are the effective lengths of the minimum center through holes, respectively, which are clearance fits with the shaft diameter D3 of the push shaft 23. The clearances are W1 and W2, respectively, and the range of W1 and W2 is 0.001~0.03mm. Through the clearance fit between the center through hole at the connection of the mounting base 12 and the claw seat 221 and the small shaft diameter of the push shaft 23, a radial constraint is formed on the push shaft 23. This makes the flexible push shaft 23 have strong rigidity in the meshing area of ​​the mounting base 12 and the claw seat 221, and it is not easy to undergo lateral deformation. This ensures that the axial meshing surface A of the mounting base 12 and the claw seat 221 is effective and stable, and there will be no disengagement. At the same time, the lengths of L2 and L3 of the mounting base 12 and the claw seat 221 can be minimized as much as possible. If the assembly clearance between the claw seat 221 and the mounting base 12 and the push shaft 23 is large, or if the difference in clearance between them is large, the clamp 10 will experience a large initial opening force. In this case, the flexible push shaft 23 is prone to large lateral deformation, causing the claw seat 221 to fail to firmly grip the mounting base 12. This leads to the axial engagement of the mounting base 12 and the claw seat 221 disengaging, resulting in the clamp 10 failing to open. The clamping system 100 of this invention limits the radial distance between the wall of the minimum central hole on the mounting base and the claw seat that allows the push shaft to pass through, thus creating an effective radial constraint on the push shaft at the connection point. This improves the rigidity of the push shaft at the connection point and ensures the stability of the clamp and pusher engagement and connection in the clamping system. Simultaneously, the axial length of the mounting base and the claw seat can be minimized, maximizing the clamp's capture area while minimizing its design. In other embodiments, the absolute value of the difference between W1 and W2 is further limited to no more than 0.02 mm. This limitation further constrains the radial range of motion of the push shaft 23, thereby enhancing the rigidity of the connection and improving the connection stability.

[0066] Specifically, refer to Figure 7 As shown, the mounting base 12 includes an axially connected mounting base fixing part 121 and a mounting base connecting part 122 located on the proximal side of the mounting base fixing part 121. The mounting base fixing part 121 is located at the distal end and is fixedly connected to the proximal end of the guide tube 11. The mounting base connecting part 122 is located at the proximal end and is used for detachable connection with the hook seat 221. The mounting base fixing part 121 is provided with a first mounting base center hole 121a, and the mounting base connecting part 122 is provided with a second mounting base center hole 122a. The first mounting base center hole 121a and the second mounting base center hole 122a are connected to allow the push shaft 23 to pass through. The second mounting base center hole 122a is the smallest center hole on the mounting base 12 through which the push shaft 23 can pass.

[0067] Adaptive, refer to Figure 8 As shown, the hook seat 221 includes a seat body 221a, which includes an axially connected hook fixing part 2211 and a hook connecting part 2212 located at the distal end of the hook fixing part 2211. The hook fixing part 2211 is located at the proximal end for fixed connection with the distal end of the push sheath 22, and the hook connecting part 2212 is located at the distal end for detachable connection with the hanging platform 12. The hook fixing part 2211 is provided with a first hook center hole 2211a, and the hook connecting part 2212 is provided with a second hook center hole 2212a. The first hook center hole 2211a and the second hook center hole 2212a are connected to allow the push shaft 23 to pass through. The second hook center hole 2212a is the smallest center hole on the hook seat 221 that allows the push shaft 23 to pass through. The axial position of the second hook center hole 2212a is connected to the axial position of the second mounting center hole 122a on the mounting base 12, thereby forming an effective radial constraint over a certain axial length at the connection point and ensuring the stability of the meshing connection.

[0068] Combination Figure 6 and Figure 8 As shown, in another embodiment, the diameter of the central hole 2211a of the first hook is larger than the diameter of the central hole 2212a of the second hook. The distal end of the push sheath 22 extends into the central hole 2211a of the first hook and is fixedly connected to the hook fixing part 2211. The radial distance between the push shaft 23, which extends from the hook seat 221 at the distal end of the push sheath 22, and the push sheath 22 is W3, which is greater than W2. The central hole of the push sheath 22 serves as the assembly channel for the push shaft 23 and also as the exhaust channel for the push sheath 22. W2 and W3 are the assembly gaps between the hook seat 221 and the push sheath 22 and the push shaft 23, respectively. To facilitate exhaust and meet structural and functional requirements, the gap W3 is greater than W2. The gap W2 better constrains the push shaft 23 to prevent deformation, while the reserved W3 meets the exhaust requirements.

[0069] Reference Figure 10 As shown, in one embodiment where the mounting base 12 and the hook base 221 are detachably connected, the mounting base connecting part 122 includes a first connecting part 1221 coaxially disposed with the mounting base fixing part 121 and a hook platform 1222 disposed on the first connecting part 1221. The partial axial projection of the first connecting part 1221 in the circumferential direction overlaps with the projection of the mounting base fixing part 121. The axial projection of the other parts of the first connecting part 1221 in the circumferential direction is located within the projection of the mounting base fixing part 121. The hook platform 1222 is formed by extending in an arc shape in the circumferential direction from a local position of the first connecting part 1221. The proximal end face of the hook platform 1222 is flush with the proximal end face of the first connecting part 1221. The distal end face of the hook platform 1222 is opposite to the proximal end face of the mounting base fixing part 121 and there is a gap groove 1223 between them.

[0070] Adaptive, refer to Figure 8 As shown, the hook connection portion 2212 includes a second connection portion 22121 located at the proximal end and a hook portion 22122 located at the distal end. The hook portion 22122 includes a C-shaped hook platform 22122a located at the distal end and a C-shaped groove 22122b located between the C-shaped hook platform 22122a and the second connection portion 22121. The C-shaped hook platform 22122a and the C-shaped groove 22122b are radially opposite to each other and their axial projection portions overlap.

[0071] Reference Figure 11 As shown, when the mounting bracket 122 of the mounting bracket 12 and the hook claw connecting portion 2212 of the hook claw bracket 221 are detachably connected, the mounting bracket connecting portion 122 and the hook claw connecting portion 2212 are axially opposite each other. The hook mounting bracket 1222 extends into the C-shaped groove 22122b, and the C-shaped hook claw 22122a is placed in the spacer groove 1223. The proximal end face of the hook mounting bracket 1222 and the distal end face of the C-shaped hook claw 22122a abut against each other, forming an axial limit between them. Figure 7 and Figure 8 The axial force-bearing surface A in the middle forms a limit in the upward direction.

[0072] When the push shaft 23 passes through the hook seat 221 and the mounting base 12, and the hook seat 221 is in the maximum radial offset position relative to the mounting base 12, the proximal end face of the hook mounting base 1222 and the distal end face of the c-shaped hook seat 22122a are in surface contact. That is, as shown in 12, when the push sheath 22 and the hook seat 221 located at its distal end are in the maximum radial offset relative to the axis Y ( Figure 12 (If the relative axis Y is offset upwards or downwards), the proximal end face of the hook platform 1222 and the distal end face of the c-shaped claw platform 22122a are still in surface contact, meaning that the engagement at point A is still surface engagement. (Refer to...) Figure 12 As shown, when the mounting base 12, the claw seat 221, and the push shaft 23 are correctly assembled and in a meshing state, A is the axial meshing position and the meshing surface is a radial straight surface (i.e., a radial tangent perpendicular to the axis). Adjacent surfaces have rounded corners for smooth transition, facilitating disengagement. Simultaneously, the size of the meshing radial surface at A is strictly controlled, requiring the meshing size at A to be slightly larger than the maximum deformation size of the overall mechanism under stress. This ensures both stable and effective opening and closing of the clamp 10 and easy release of the clamp 10 connected to the release mechanism. B is the radial limiting surface (i.e., an axial tangent perpendicular to the axis) in the gripping structure of the mounting base 12 and the claw seat 221. C and D are also axial limiting surfaces. B, C, and D, together with A, prevent and limit large rotation and radial displacement of the clamp 10 in the meshing area. In a specific implementation, this can be achieved by limiting the mating clearance at D and C. For example, the mating clearance at C and D is less than 0.03 mm.

[0073] Reference Figure 10, Figure 11 and Figure 13 Based on the aforementioned detachable connection, this embodiment proposes a more optimized connection method. In this method, the outer peripheral surface of the first connecting portion 1221 at the interval groove 1223 is plane E, and the inner walls of both sides of the c-shaped claw platform 22122a are plane F. When the hanging platform connecting portion 122 and the claw connecting portion 2212 are detachably connected, the first connecting portion 1221 at the interval groove 1223 and the c-shaped claw platform 22122a are two planes facing each other, i.e. Figure 11 Planes F and E in the clamping system are opposite each other. The circumferential torsional control at the connection between the clamper 10 and the pusher 20 in the clamping system is controlled by the engagement of structures E and B in the mounting base 12 and structures F and B in the claw seat 221 to control the torsional property of the clamper 10 and achieve good torsional synchronization. Structures E in the mounting base 12 and F in the claw seat 221 are specifically designed as planar structures to increase the contact torque between them, ensuring the torsional synchronization of the clamping system. This allows the torsional action at the proximal end to be quickly transmitted to the distal end for a rapid response. More importantly, while enabling the detachable connection between the claw seat 221 and the mounting base 12, it also allows for quick separation, facilitating release.

[0074] Reference Figure 8 As shown, in another embodiment, the hook base 221 also includes an end cap 2213 extending radially outward from the outer periphery of the base body 221a. The end cap 2213 is provided with a through hole 2213a through which the adjustment line can pass. There are multiple through holes 2213a, and the multiple through holes 2213a are spaced apart along the circumference of the end cap 2213.

[0075] Preferably, the outer wall of the hook fixing part 2211 is provided with a plurality of protrusions 2211b, which are spaced apart along the outer periphery of the hook fixing part 2211. A recess 2211c is formed between each pair of adjacent protrusions 2211b. When the push sheath 22 is connected to the hook fixing part 2211, the inner tube of the push sheath 22 extends into the center hole 2211a of the first hook and is fixedly connected to the hook fixing part 2211. The outer tube of the push sheath 22 is sleeved on the hook fixing part 2211 and fixedly connected to the hook fixing part 2211. Part of the outer tube extends into the recess 2211c. The outer tube is usually a plastic tube. After hot melting, part of the outer tube fills the recess 2211c and part of it is connected to the protrusions 2211b, thereby improving the connection firmness between the hook seat 221 and the push sheath and effectively ensuring the connection performance.

[0076] In other embodiments, refer to Figure 14As shown, the clamping system 100 also includes an adjustable curved sheath 30. After puncturing the interatrial septum via the femoral vein, the adjustable curved sheath 30 establishes a delivery path for the push sheath in the left atrium for precise valve capture. For example, the adjustable curved sheath 30 includes an adjustable curved handle 31 and an adjustable curved sheath tube 32. The proximal end of the adjustable curved sheath tube 32 extends into and connects to the adjustable curved handle 31. The push sheath tube 22 of the pusher 20 passes through the adjustable curved sheath 30. Since the clamping system 100 also needs to establish a path through a large sheath, the distal end of the clamping system 100 can extend into the large sheath. To locate the position of the clamping system relative to the large sheath, a first mark 32a is provided near the adjustable curved handle of the adjustable curved sheath tube 32. The first mark 32a allows for quantitative measurement of the forward or backward movement of the clamping system relative to the large sheath, thereby enabling more precise control of the entire process. Furthermore, the adjustable bending sheath 30 also includes a sleeve 33 connected between the push handle 21 and the adjustable bending handle 31, wherein the sleeve 33 is provided with a second mark 33a, which is used to precisely control the forward or backward movement of the pusher 20 relative to the adjustable bending sheath 30. Furthermore, the clamping system also includes a loading sheath 40 for loading and inserting the clamp 10.

[0077] Example 2

[0078] This embodiment provides a clamp 10 for clamping tissue. The structure of the clamp 10 in this embodiment can be entirely described in the section on clamp 10 in Embodiment 1 above. The clamp 10 is a valve repair implant, which mainly uses the clamping assembly 14 to capture and clamp the valve leaflets, thereby reducing the degree of regurgitation.

[0079] For details, see Figure 5 As shown, the clamping device 10 includes a guide tube 11, a mounting base 12, a release seat 13, and a clamping assembly 14. The mounting base 12 is fixed to the proximal end of the guide tube 11, and the distal end of the guide tube 11 is axially slidably connected to the release seat 13. The clamping assembly 14 includes at least two clamping portions 141 located outside the guide tube 11. For example, the two clamping portions 141 are symmetrically arranged relative to the guide tube 11. One end of each clamping portion 141 is pivotally connected to the guide tube 11 to form a pivot position 17, and the other end is fixedly connected to the release seat 13 to form a fixed position 18. The clamping portions 141 can open and close during the change of the axial distance between the pivot position 17 and the fixed position 18.

[0080] Reference Figure 5As shown, in other embodiments, the clamping device 10 further includes a spacer 15, which is a cage-like structure fitted onto the guide tube 11 and fixed to the guide tube 11 after its two ends are constricted. In this embodiment, the spacer 15 is a deformable cage-like structure woven from elastic metal wire, and its surface can be covered with a polymer film, such as PET cloth or PTFE film. After the clamping device 10 clamps the leaflets, the spacer 15 serves as a sealing and filling function, and its deformability also helps to reduce stress during leaflet clamping.

[0081] Continue to refer to Figure 5 As shown, in other embodiments, the clamp 10 further includes a fixing seat 16, which is fixed to the guide tube 11 near its distal end. The clamping portion 141 is pivotally connected to the fixing seat 16, forming a pivot position 17 at the pivot point. For example, as... Figure 5 As shown, the clamping part 141 includes a clamping arm 1411 and a supporting arm 1412. One end of the clamping arm 1411 is fixedly connected to the release seat 13, and the other end is pivotally connected to the supporting arm 1412. The other end of the supporting arm 1412 is pivotally connected to the fixed seat 16 to form a pivot position 17. The supporting arm 1412 and the clamping arm 1412 are rotatably connected. The clamping arm 1411 can be made of a highly elastic metal material, such as nickel-titanium wire, to provide clamping force when the clamping device 10 clamps. The supporting arm 1412 can be made of a metal or polymer material with certain rigidity and toughness to provide the function of opening the clamping arm 1411.

[0082] Continue to refer to Figure 5 As shown, in other embodiments, the clamping assembly 14 further includes hooks 142, two hooks 142 are symmetrically arranged, one end of the hook 142 is fixed to the distal end of the guide tube 11, and the other end is a free end. The hooks 142 are located between the guide tube 11 and the clamping part 141. When the spacer 15 is present, the hooks 142 are located between the spacer 15 and the clamping part 141. Exemplarily, as a way to fix the hooks 142 to the guide tube 11, when the fixing seat 16 is present, the two hooks 142 can be integrally formed, and the middle connecting part is fixed to the fixing seat 16. The hooks 142 are provided with barbs (not shown), and the barbs are opposite to the clamping part 141. The hook 142 can be made of a highly elastic metal material. When the free end of the hook 142 is pulled up, the hook 142 fits against the spacer 15 and forms a certain angle with the support arm 1412. When the free end of the hook 142 is released, the hook's own elasticity causes it to approach and fit against the support arm 1412 on the corresponding side, which is used to capture the leaflet during surgery.

[0083] Among them, such as Figure 6As shown, the radial distance between the wall of the smallest central hole on the mounting base 12 through which the push shaft 23 can pass and the push shaft 23 is W1, and W1 ranges from 0.001 to 0.03 mm. In other embodiments, the radial distance between the wall of the smallest central hole on the claw seat 221 of the pusher 20 through which the push shaft 23 can pass and the push shaft 23 is W2, and the absolute value of the difference between W1 and W2 is not greater than 0.02 mm. Through the clearance fit between the central through hole at the connection between the mounting base 12 and the claw seat 221 and the small diameter of the push shaft 23, a radial constraint is formed on the push shaft 23, so that the flexible push shaft 23 has strong rigidity in the biting area of ​​the mounting base 12 and the claw seat 221, and is not prone to lateral deformation. This ensures that the axial biting surface A of the mounting base 12 and the claw seat 221 is effective and stable, and does not cause disengagement. At the same time, the lengths L2 and L3 of the mounting base 12 and the claw seat 221 can be minimized in the design. If the assembly clearance between the claw seat 221 or the mounting base 12 and the push shaft 23 is large, or the difference in clearance between the two is large, the clamp 10 will experience a large initial opening force. At this time, the flexible push shaft 23 is easily driven and undergoes large lateral deformation, causing the claw seat 221 to fail to firmly grip the mounting base 12. The axial engagement between the mounting base 12 and the claw seat 221 will disengage, resulting in the clamp 10 failing to open. The clamping system 100 of this embodiment limits the radial distance between the wall of the minimum central hole on the mounting base and the claw seat that allows the push shaft to pass through and the push shaft. This creates an effective radial constraint on the push shaft passing through at the connection point, improving the rigidity of the push shaft at the connection point and ensuring the engagement and connection stability of the clamp and pusher in the clamping system. At the same time, the axial length of the mounting base and the claw seat can be minimized as much as possible, which can maximize the capture area of ​​the clamp while minimizing the clamp design. The absolute value of the difference between W1 and W2 is no greater than 0.02mm. This limitation further constrains the radial range of motion of the push shaft 23, thereby enhancing the rigidity of the connection and improving the connection stability.

[0084] Specifically, refer to Figure 7 As shown, the mounting base 12 includes an axially connected mounting base fixing part 121 and a mounting base connecting part 122 located on the proximal side of the mounting base fixing part 121. The mounting base fixing part 121 is located at the distal end and is fixedly connected to the proximal end of the guide tube 11. The mounting base connecting part 122 is located at the proximal end and is used for detachable connection with the hook seat 221. The mounting base fixing part 121 is provided with a first mounting base center hole 121a, and the mounting base connecting part 122 is provided with a second mounting base center hole 122a. The first mounting base center hole 121a and the second mounting base center hole 122a are connected to allow the push shaft 23 to pass through. The second mounting base center hole 122a is the smallest center hole on the mounting base 12 through which the push shaft 23 can pass.

[0085] For example, the mounting bracket connecting part 122 includes a first connecting part 1221 coaxially disposed with the mounting bracket fixing part 121 and a hook mounting bracket 1222 disposed on the first connecting part 1221. The partial axial projection of the first connecting part 1221 in the circumferential direction overlaps with the projection of the mounting bracket fixing part 121. The axial projection of the other parts of the first connecting part 1221 in the circumferential direction is located within the projection of the mounting bracket fixing part 121. The hook mounting bracket 1222 is formed by extending in an arc shape in the circumferential direction from a local position of the first connecting part 1221. The proximal end face of the hook mounting bracket 1222 is flush with the proximal end face of the first connecting part 1221. The distal end face of the hook mounting bracket 1222 is opposite to the proximal end face of the mounting bracket fixing part 121 and there is a spacer groove 1223 between them.

[0086] Reference Figure 11 As shown, when the mounting bracket 122 of the mounting bracket 12 and the hook claw connecting portion 2212 of the hook claw bracket 221 are detachably connected, the mounting bracket connecting portion 122 and the hook claw connecting portion 2212 are axially opposite each other. The hook mounting bracket 1222 extends into the C-shaped groove 22122b, and the C-shaped hook claw 22122a is placed in the spacer groove 1223. The proximal end face of the hook mounting bracket 1222 and the distal end face of the C-shaped hook claw 22122a abut against each other, forming an axial limit between them. Figure 7 and Figure 8 The axial force-bearing surface A in the middle forms a limit in the upward direction.

[0087] Reference Figure 10 , Figure 11 and Figure 13 Preferably, the outer peripheral surface of the first connecting portion 1221 at the interval groove 1223 is plane E. In this case, the inner walls of both sides of the c-shaped claw platform 22122a are plane F. When the hanging platform connecting portion 122 and the claw connecting portion 2212 are detachably connected, the first connecting portion 1221 at the interval groove 1223 and the c-shaped claw platform 22122a are two planes facing each other, i.e. Figure 11 Planes F and E in the clamping system are opposite each other. The circumferential torsional control at the connection between the clamper 10 and the pusher 20 in the clamping system is controlled by the engagement of structures E and B in the mounting base 12 and structures F and B in the claw seat 221 to control the torsional property of the clamper 10 and achieve good torsional synchronization. Structures E in the mounting base 12 and F in the claw seat 221 are specifically designed as planar structures to increase the contact torque between them, ensuring the torsional synchronization of the clamping system. This allows the torsional action at the proximal end to be quickly transmitted to the distal end for a rapid response. More importantly, while enabling the detachable connection between the claw seat 221 and the mounting base 12, it also allows for quick separation, facilitating release.

[0088] Example 3

[0089] This embodiment provides a pusher 20 for pushing the clamp 10. The structure of the pusher 20 in this embodiment can be entirely referred to the description of the pusher 20 in Embodiment 1 above. The pusher 20 is mainly used for pushing, opening, capturing, closing, retrieving, and releasing the clamp 10.

[0090] Specifically, refer to Figures 2-4 As shown, the pusher 20 includes a push handle 21, a push sheath 22, a push shaft 23, and a drive module 24. The drive module 24 is connected to the proximal end of the push handle 21. The proximal end of the push sheath 22 extends into the push handle 21 and is fixed relative to the push handle 21. The distal end of the push sheath 22 is fixedly connected to a claw seat 221, which is used for detachable connection with the mounting base 12. The push shaft 23 is movably placed inside the push sheath 22, and the proximal end of the push shaft 23 passes through the push handle 21 and is connected to the drive module 24 located at the proximal end of the push handle 21. The distal end of the push shaft 23 can pass out from the claw seat 221 at the distal end of the push sheath 22 and pass through the mounting base 12 and the guide tube 11 to be detachably connected to the release seat 13. Driven by the drive module 24, the push shaft 23 can cause the release seat 13, which is detachably connected to it, to move axially relative to the guide tube 11. This movement changes the axial distance between the pivot position 17 and the fixed position 18 of the clamping part 141. The change in the axial distance between the pivot position 17 and the fixed position 18 enables the clamping part 141 to open and close.

[0091] Reference Figure 4 As shown, exemplarily, the drive module 24 includes a drive knob 241 and a moving component 242; rotating the drive knob 241 causes the moving component 242 to move linearly back and forth, controlling the opening, straightening, and closing of the coupling. The moving component 242 includes a threaded drive post 2421, a safety key 2422, and a release component 2423. The threaded drive post 2421 is threadedly engaged with the drive knob 241; the safety key 2422 is a safety switch key for the release component 2423, allowing the release component 2423 to be fixed and separated from the threaded drive post 2421; when the release component 2423 is separated from the threaded drive post 2421, rotating the release component 2423 disengages the distal thread of the push shaft 23 from the threaded release seat, and then pulling out the release component 2423 disengages the push shaft 23 from the clamp 10, achieving the effect of releasing the clamp 10.

[0092] Continue to refer to Figure 4 As shown, the pusher 20 also includes a push-pull rod module 25, which is used to control the adjustment line, which is connected to the free end of the hook 142.

[0093] Among them, such as Figure 6As shown, the radial distance between the wall of the smallest central hole on the claw seat 221 through which the push shaft 23 can pass and the push shaft 23 is W2, and the range of W2 is 0.001~0.03mm. Preferably, the radial distance between the wall of the smallest central hole on the mounting base 12 of the clamping device 10 through which the push shaft 23 can pass and the push shaft 23 is W1, and the absolute value of the difference between W1 and W2 is not greater than 0.02mm. Through the clearance fit between the central through hole at the connection between the mounting base 12 and the claw seat 221 and the small diameter of the push shaft 23, a radial constraint is formed on the push shaft 23, so that the flexible push shaft 23 has strong rigidity in the biting area of ​​the mounting base 12 and the claw seat 221, and is not prone to lateral deformation. This ensures that the axial biting surface A of the mounting base 12 and the claw seat 221 is effective and stable, and does not cause disengagement. At the same time, the lengths L2 and L3 of the mounting base 12 and the claw seat 221 can be minimized as much as possible. If the assembly clearance between the claw seat 221 or the mounting base 12 and the push shaft 23 is large, or if the difference in clearance between the two is large, the clamp 10 will experience a large initial opening force. In this case, the flexible push shaft 23 is prone to significant lateral deformation, causing the claw seat 221 to fail to firmly grip the mounting base 12. This leads to the axial engagement of the mounting base 12 and the claw seat 221 disengaging, resulting in the clamp 10 failing to open. The clamping system of this embodiment, by limiting the radial distance between the wall of the minimum central hole on the mounting base and the claw seat that allows the push shaft to pass through, effectively constrains the push shaft at the connection point, improving the rigidity of the push shaft at the connection point and ensuring the stability of the clamping system's engagement and connection between the clamp and the pusher. Simultaneously, the axial length of the mounting base and the claw seat can be minimized, maximizing the clamp's capture area while minimizing its design. The absolute value of the difference between W1 and W2 is further limited to no more than 0.02 mm. This limitation further constrains the radial range of motion of the push shaft 23, thereby enhancing the rigidity of the connection and improving the connection stability.

[0094] Reference Figure 8As shown, the hook seat 221 includes a seat body 221a, which includes an axially connected hook fixing part 2211 and a hook connecting part 2212 located at the distal end of the hook fixing part 2211. The hook fixing part 2211 is located at the proximal end for fixed connection with the distal end of the push sheath 22, and the hook connecting part 2212 is located at the distal end for detachable connection with the hanging platform 12. The hook fixing part 2211 is provided with a first hook center hole 2211a, and the hook connecting part 2212 is provided with a second hook center hole 2212a. The first hook center hole 2211a and the second hook center hole 2212a are connected to allow the push shaft 23 to pass through. The second hook center hole 2212a is the smallest center hole on the hook seat 221 that allows the push shaft 23 to pass through. The axial position of the center hole 2212a of the second claw is connected axially to the center hole 122a of the second mounting base 12, thereby forming an effective radial constraint at the connection and ensuring the stability of the interlocking connection.

[0095] Combination Figure 6 and Figure 8 As shown, in another embodiment, the diameter of the central hole 2211a of the first hook is larger than the diameter of the central hole 2212a of the second hook. The distal end of the push sheath 22 extends into the central hole 2211a of the first hook and is fixedly connected to the hook fixing part 2211. The radial distance between the push shaft 23, which extends from the hook seat 221 at the distal end of the push sheath 22, and the push sheath 22 is W3, which is greater than W2. The central hole of the push sheath 22 serves as the assembly channel for the push shaft 23 and also as the exhaust channel for the push sheath 22. W2 and W3 are the assembly gaps between the hook seat 221 and the push sheath 22 and the push shaft 23, respectively. To facilitate exhaust and meet structural and functional requirements, the gap W3 is greater than W2. The gap W2 better constrains the push shaft 23 to prevent deformation, while the reserved W3 meets the exhaust requirements.

[0096] Reference Figure 8 As shown, the hook connection portion 2212 includes a second connection portion 22121 located at the proximal end and a hook portion 22122 located at the distal end. The hook portion 22122 includes a C-shaped hook platform 22122a located at the distal end and a C-shaped groove 22122b located between the C-shaped hook platform 22122a and the second connection portion 22121. The C-shaped hook platform 22122a and the C-shaped groove 22122b are radially opposite to each other and their axial projection portions overlap.

[0097] Reference Figure 11As shown, when the mounting bracket 122 of the mounting bracket 12 and the hook claw connecting portion 2212 of the hook claw bracket 221 are detachably connected, the mounting bracket connecting portion 122 and the hook claw connecting portion 2212 are axially opposite each other. The hook mounting bracket 1222 extends into the C-shaped groove 22122b, and the C-shaped hook claw 22122a is placed in the spacer groove 1223. The proximal end face of the hook mounting bracket 1222 and the distal end face of the C-shaped hook claw 22122a abut against each other, forming an axial limit between them. Figure 7 and Figure 8 The axial force-bearing surface A in the middle forms a limit in the upward direction.

[0098] Reference Figure 10 , Figure 11 and Figure 13 Based on the aforementioned detachable connection, this embodiment proposes a more optimized connection method. In this method, the outer peripheral surface of the first connecting portion 1221 at the interval groove 1223 is plane E, and the inner walls of both sides of the c-shaped claw platform 22122a are plane F. When the hanging platform connecting portion 122 and the claw connecting portion 2212 are detachably connected, the first connecting portion 1221 at the interval groove 1223 and the c-shaped claw platform 22122a are two planes facing each other, i.e. Figure 11 Planes F and E in the clamping system are opposite each other. The circumferential torsional control at the connection between the clamper 10 and the pusher 20 in the clamping system is controlled by the engagement of structures E and B in the mounting base 12 and structures F and B in the claw seat 221 to control the torsional property of the clamper 10 and achieve good torsional synchronization. Structures E in the mounting base 12 and F in the claw seat 221 are specifically designed as planar structures to increase the contact torque between them, ensuring the torsional synchronization of the clamping system. This allows the torsional action at the proximal end to be quickly transmitted to the distal end for a rapid response. More importantly, while enabling the detachable connection between the claw seat 221 and the mounting base 12, it also allows for quick separation, facilitating release.

[0099] Reference Figure 8 As shown, in another embodiment, the hook base 221 also includes an end cap 2213 extending radially outward from the outer periphery of the base body 221a. The end cap 2213 is provided with a through hole 2213a through which the adjustment line can pass. There are multiple through holes 2213a, and the multiple through holes 2213a are spaced apart along the circumference of the end cap 2213.

[0100] Preferably, the outer wall of the hook fixing part 2211 is provided with a plurality of protrusions 2211b, which are spaced apart along the outer periphery of the hook fixing part 2211. A recess 2211c is formed between each pair of adjacent protrusions 2211b. When the push sheath 22 is connected to the hook fixing part 2211, the inner tube of the push sheath 22 extends into the center hole 2211a of the first hook and is fixedly connected to the hook fixing part 2211. The outer tube of the push sheath 22 is sleeved on the hook fixing part 2211 and fixedly connected to the hook fixing part 2211. Part of the outer tube extends into the recess 2211c. The outer tube is usually a plastic tube. After hot melting, part of the outer tube fills the recess 2211c and part of it is connected to the protrusions 2211b, thereby improving the connection firmness between the hook seat 221 and the push sheath and effectively ensuring the connection performance.

[0101] The clamping system, clamper, and pusher of this invention, by limiting the radial distance between the wall of the minimum central hole on the mounting base and the claw base through which the push shaft can pass and the push shaft, effectively constrain the push shaft passing through at the connection point, improving the rigidity of the push shaft at the connection point and ensuring the engagement and connection stability of the clamper and pusher in the clamping system. Simultaneously, the axial length of the mounting base and the claw base can be minimized, maximizing the clamping area while minimizing the clamper's design. Furthermore, when the push shaft passes through the claw base and the mounting base and the claw base is at its maximum radial offset relative to the mounting base, the proximal end face of the hook-hanging platform and the distal end face of the C-shaped claw platform remain in surface contact. This method ensures both stable and effective opening and closing of the clamper and easy release of the clamper's connection and release mechanism. Furthermore, when the mounting base and the claw base are detachably connected, the first connecting part at the interval groove of the mounting base and the C-shaped claw base of the claw base are two planes facing each other. The contact torque between the two planes increases the contact torque between them, ensuring the torsional synchronization of the clamping system, so that the torsional action at the proximal end can be quickly transmitted to the distal end and a rapid response can be obtained.

[0102] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this invention.

[0103] The above embodiments merely illustrate several implementation methods of the present invention, and their descriptions are relatively specific and detailed, but they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. A clamping system, characterized in that, Includes a clamp and a pusher detachably connected to the clamp; The clamping device includes a guide tube, a mounting base, a release seat, and a clamping assembly. The mounting base is fixed to the proximal end of the guide tube, and the distal end of the guide tube is axially slidably connected to the release seat. The clamping assembly includes at least two clamping portions located on the outside of the guide tube. One end of each clamping portion is pivotally connected to the guide tube to form a pivot position, and the other end is fixedly connected to the release seat to form a fixed position. The clamping portion can open and close during the change of the axial distance between the pivot position and the fixed position. The pusher includes a push handle, a push sheath, a push shaft, and a drive module. The drive module is connected to the push handle. The proximal end of the push sheath extends into the push handle and is fixed relative to it. The distal end of the push sheath is fixed to a hook seat, which is detachably connected to the mounting base. The push shaft is movably placed inside the push sheath, and the proximal end of the push shaft is connected to the drive module via the push handle. The distal end of the push shaft can be detachably connected to the release seat after passing through the hook seat, the mounting base, and the guide tube in sequence. The push shaft can drive the release seat to move axially relative to the guide tube under the drive of the drive module, thereby changing the axial distance between the pivot position and the fixed position of the clamping part. The radial distances between the wall of the smallest central hole on the mounting base and the hook base through which the push shaft can pass and the push shaft are W1 and W2, respectively, and the range of W1 and W2 is 0.001 mm to 0.03 mm.

2. The clamping system according to claim 1, characterized in that, The mounting base includes an axially connected mounting base fixing part and a mounting base connecting part located near the proximal end of the mounting base fixing part. The mounting base fixing part is fixedly connected to the proximal end of the guide tube, and the mounting base connecting part is used for detachable connection with the hook seat. The mounting base fixing part is provided with a first mounting base center hole, and the mounting base connecting part is provided with a second mounting base center hole. The first mounting base center hole and the second mounting base center hole are connected to allow the push shaft to pass through. The second mounting base center hole is the smallest center hole on the mounting base that allows the push shaft to pass through. The hook holder includes a base body, which includes an axially connected hook fixing part and a hook connecting part located at the distal end of the hook fixing part. The hook fixing part is fixedly connected to the distal end of the push sheath tube, and the hook connecting part is used for detachable connection with the hanging platform. The hook fixing part is provided with a first hook center hole, and the hook connecting part is provided with a second hook center hole. The first hook center hole and the second hook center hole are connected to allow the push shaft to pass through. The second hook center hole is the smallest center hole on the hook holder that allows the push shaft to pass through.

3. The clamping system according to claim 2, characterized in that, The diameter of the central hole of the first hook is larger than the diameter of the central hole of the second hook. The distal part of the push sheath extends into the central hole of the first hook and is fixedly connected to the hook fixing part. The radial distance between the push shaft extending from the hook seat at the distal end of the push sheath and the push sheath is W3, and W3 is greater than W2.

4. The clamping system according to claim 2, characterized in that, The mounting bracket connecting part includes a first connecting part coaxially arranged with the mounting bracket fixing part and a hook platform disposed on the first connecting part. A partial axial projection of the first connecting part in the circumferential direction overlaps with the projection of the mounting bracket fixing part, and the axial projection of other parts of the first connecting part in the circumferential direction is located within the projection of the mounting bracket fixing part. The hook platform is formed by extending in an arc shape in the circumferential direction from a local position of the first connecting part. The proximal end face of the hook platform is flush with the proximal end face of the first connecting part, and the distal end face of the hook platform is opposite to the proximal end face of the mounting bracket fixing part and there is a gap groove between them. The hook connection portion includes a second connection portion located at the proximal end and a hook portion located at the distal end. The hook portion includes a C-shaped hook platform located at the distal end and a C-shaped groove located between the C-shaped hook platform and the second connection portion. The C-shaped hook platform and the C-shaped groove are radially opposite to each other and partially overlap. When the mounting bracket connecting part of the mounting bracket and the hook claw connecting part of the hook claw base are detachably connected, the mounting bracket connecting part and the hook claw connecting part are axially opposite each other, the hook mounting bracket extends into the C-shaped groove, the C-shaped hook claw is placed in the spacer groove, and the proximal end face of the hook mounting bracket and the distal end face of the C-shaped hook claw are abutted against each other to form an axial limit.

5. The clamping system according to claim 4, characterized in that, When the push shaft passes through the hook seat and the hanging platform seat and the hook seat is in the maximum radial offset position relative to the hanging platform seat, the proximal end face of the hook hanging platform and the distal end face of the C-shaped hook seat are still in surface contact.

6. The clamping system according to claim 4 or 5, characterized in that, The outer peripheral surface of the first connecting part at the interval groove is a plane, and the inner walls of both sides of the C-shaped claw platform are planes. When the hanging platform connecting part and the claw connecting part are detachably connected, the first connecting part at the interval groove and the C-shaped claw platform are two planes facing each other.

7. The clamping system according to claim 2, characterized in that, The hook seat also includes an end cap extending radially outward from the outer periphery of the seat body. The end cap has through holes through which the adjustment line can pass. There are multiple through holes, which are spaced apart circumferentially along the end cap.

8. The clamping system according to claim 2, characterized in that, The outer wall of the hook fixing part is provided with a plurality of protrusions, which are spaced apart along the outer periphery of the hook fixing part. A recess is formed between each pair of adjacent protrusions. When the push sheath is connected to the hook fixing part, the inner tube of the push sheath extends into the central hole of the first hook and is fixedly connected to the hook fixing part. The outer tube of the push sheath is sleeved on the hook fixing part and fixedly connected to the hook fixing part, wherein a portion of the outer tube extends into the recess.

9. A clamp for clamping tissue, characterized in that, The device includes a guide tube, a mounting base, a release seat, and a clamping assembly. The mounting base is fixed to the proximal end of the guide tube, and the distal end of the guide tube is axially slidably connected to the release seat. The clamping assembly includes at least two clamping portions located outside the guide tube. One end of each clamping portion is pivotally connected to the guide tube, forming a pivot position, and the other end is fixedly connected to the release seat, forming a fixed position. Under the action of external force, the release seat and the guide tube can move axially, thereby changing the axial distance between the pivot position and the fixed position of the clamping portion and thus realizing the opening and closing of the clamp. The radial distance between the wall of the smallest central hole on the mounting base through which the pusher's push shaft passes and the pusher shaft is W1, and the range of W1 is 0.001 mm to 0.03 mm.

10. The clamping device according to claim 9, characterized in that, The mounting base includes an axially connected mounting base fixing part and a mounting base connecting part disposed on the proximal side of the mounting base fixing part. The mounting base fixing part is fixedly connected to the proximal end of the guide tube, and the mounting base connecting part is used for detachable connection with the hook base of the pusher. The mounting bracket connecting part includes a first connecting part coaxially arranged with the mounting bracket fixing part and a hook platform disposed on the first connecting part. A partial axial projection of the first connecting part in the circumferential direction overlaps with the projection of the mounting bracket fixing part, and the axial projection of other parts of the first connecting part in the circumferential direction is located within the projection of the mounting bracket fixing part. The hook platform is formed by extending in an arc shape in the circumferential direction from a local position of the first connecting part. The proximal end face of the hook platform is flush with the proximal end face of the first connecting part, and the distal end face of the hook platform is opposite to the proximal end face of the mounting bracket fixing part and there is a gap groove between them. When the mounting platform connecting part of the mounting base and the hook claw connecting part of the pusher are detachably connected, the mounting platform connecting part and the hook claw connecting part are axially opposite each other, the hook platform extends into the C-shaped groove of the hook claw connecting part, the C-shaped hook claw platform of the hook claw connecting part is placed in the spacer groove, and the proximal end face of the hook platform and the distal end face of the C-shaped hook claw platform of the hook claw connecting part abut against each other and form an axial limit between them.

11. The clamping device according to claim 10, characterized in that, The outer peripheral surface of the first connecting part at the interval groove is a plane. When the hanging platform connecting part and the pusher's hook connecting part are detachably connected, the first connecting part at the interval groove and the C-shaped hook platform of the hook connecting part are two planes facing each other.

12. A pusher for pushing a clamping device, characterized in that, The pusher includes a push handle, a push sheath, a push shaft, and a drive module. The drive module is connected to the push handle. The proximal end of the push sheath extends into the push handle and is fixed relative to it. A hook seat is fixed at the distal end of the push sheath. The hook seat is detachably connected to the clamp's mounting base. The push shaft is movably placed inside the push sheath. The proximal end of the push shaft is connected to the drive module via the push handle. The distal end of the push shaft can pass through the hook seat and through the clamp's mounting base and guide tube before being detachably connected to the clamp's release seat. The push shaft can drive the release seat to move relative to the guide tube under the drive of the drive module, thereby realizing the opening and closing of the clamp; The radial distance between the wall of the smallest central hole on the claw seat through which the push shaft can pass and the push shaft is W2, and the range of W2 is 0.001 mm to 0.03 mm.

13. The pusher according to claim 12, characterized in that, The hook base includes a base body, which includes an axially connected hook fixing part and a hook connecting part located at the distal end of the hook fixing part. The hook fixing part is fixedly connected to the distal end of the push sheath, and the hook connecting part is used for detachable connection with the clamping device's mounting base. The hook connection portion includes a second connection portion located at the proximal end and a hook portion located at the distal end. The hook portion includes a C-shaped hook platform located at the distal end and a C-shaped groove located between the C-shaped hook platform and the second connection portion. The C-shaped hook platform and the C-shaped groove are radially opposite to each other. When the mounting plate connecting part of the clamp is detachably connected to the hook connecting part of the hook base, the mounting plate connecting part and the hook connecting part are axially opposite each other, the hook plate of the mounting plate connecting part extends into the C-shaped groove, the C-shaped hook plate is placed in the spacer groove of the mounting plate connecting part, and the proximal end face of the hook plate and the distal end face of the C-shaped hook plate abut against each other to form an axial limit.

14. The pusher according to claim 13, characterized in that, The inner walls of both sides of the C-shaped claw platform are flat. When the hanging platform connecting part of the clamping device is detachably connected to the claw connecting part, the first connecting part at the interval groove of the clamping device and the C-shaped claw platform are two planes facing each other.

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