A valve clip

Abstract

A valve clamp includes a clamping component, a coupling mechanism, a base and a locking mechanism, wherein the clamping component includes a first clamping component and a second clamping component, the first clamping component has at least two first clamping arms, the second clamping component has a corresponding number of second clamping arms, the first clamping arm and the second clamping arm are arranged at the distal end of the coupling mechanism, the coupling mechanism is a hollow structure, a first connecting structure and a second connecting structure are arranged on the coupling mechanism for connecting with a delivery sheath and a locking mechanism respectively, the locking mechanism is arranged on the base, and a third connecting structure and a fourth connecting structure for connecting with a push rod are arranged on the locking mechanism, the base is movably connected to the second clamping arm through a connecting rod, and the base can be locked and connected through the third connecting structure and the second connecting structure on the coupling mechanism. The clamp shortens the axial operation space and the length of the clamp itself, reducing the risk of thrombus formation and the possibility of damage to cardiac tissue.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to a valve clip for treating mitral valve regurgitation and tricuspid valve regurgitation. Background Art

[0002] The mitral valve is a two-valve valve attached to the periphery of the left atrioventricular orifice (such as Figure 1 It is connected to the papillary muscle by chordae tendineae and has the function of preventing blood from the left ventricle from flowing back to the left atrium.

[0003] Mitral regurgitation (MR) is caused by organic or functional changes in the mitral valve leaflets and their related structures, resulting in poor anastomosis between the anterior and posterior leaflets of the mitral valve, and blood flow back from the left ventricle to the left atrium, causing a series of pathophysiological changes. Severe MR can cause left ventricular enlargement, ultimately leading to left heart systolic failure and heart failure. At the same time, the left atrial pressure also increases due to regurgitation, which can easily lead to left atrial enlargement, atrial fibrillation and pulmonary hypertension. The prognosis of MR is poor. The annual mortality rate of patients with symptoms but no surgery is about 5%, while the 5-year mortality rate of patients with severe heart failure is as high as 60%. At the same time, MR is also one of the most common heart diseases. According to statistics, the incidence rates of people over 65 and 75 years old are 6.4% and 9.3%, respectively. With the development of the economy and society and the aging of the population, the incidence of mitral regurgitation has shown a significant upward trend.

[0004] Surgical valve repair or replacement is considered the standard treatment for this disease. However, surgery has disadvantages such as large trauma, significant postoperative pain, slow recovery, and high risk. In addition, some elderly patients with a history of open-chest surgery, poor heart function, and multiple organ dysfunction are often refused surgery due to the high risk of surgery. Therefore, the development of minimally invasive, low-risk, interventional treatment devices for MR has huge social benefits and market demand. In recent years, with the breakthrough development of valve interventional treatment technology, interventional devices for MR have become one of the key directions of cardiovascular device research and development at home and abroad.

[0005] Among them, the valve clamping device developed based on the principle of surgical valve edge-to-edge suturing technology is currently the most recognized because of its high safety, simple technical principle and high feasibility. The principle of surgical valve edge-to-edge suturing technology is shown in Figure 2: During mitral valve regurgitation, the edges of the two leaflets cannot close together during heart contraction, resulting in a gap, causing the blood flow of the left ventricle to return to the left atrium through the gap; surgical edge-to-edge suturing sutures the middle point of the edges of the two leaflets of the mitral valve, so that the gap between the leaflets disappears or becomes smaller during heart contraction, thereby reducing mitral valve regurgitation ( Figure 2a ), while the mitral valve opens into a double hole during diastole, and blood flows into the left ventricle without being affected ( Figure 2bThe only minimally invasive interventional device approved for the treatment of MR in the world is Evalve's MitraClip, a valve clamping device.

[0006] CN201610594219 discloses a valve clamping device for performing a capture and clamping operation from the ventricular side of the valve. However, it is found through actual surgical operations that the device still has defects such as too large an operating space required for capturing the valve, a relatively large wound from the apex so that the operation can only be performed from the ventricular side, easy entanglement of chordae tendineae, easy damage to the atrial roof, and only the two sides of the valve can be captured at the same time.

[0007] Therefore, those skilled in the art are committed to developing a novel valve clamping and locking mechanism and a valve clamp provided with the clamping and locking mechanism, so as to further shorten the axial operation space of the clamp. Summary of the invention

[0008] The object of the present invention is to provide a valve clamp which, on the one hand, shortens the axial operating space of the clamp, changes the operating direction, performs capture and clamping operations from the atrial surface of the valve, and reduces the risk of damage to the atrium and chordae tendineae during surgical operations; on the other hand, shortens the length of the clamp, makes the implanted clamp shorter, reduces the risk of thrombus formation, and reduces the possibility of damage to the heart tissue by the components exposed on the ventricular side of the clamp.

[0009] To achieve the above object, the present invention adopts the following technical solution:

[0010] A valve clamp, comprising a clamping component, a coupling mechanism, a base and a locking mechanism, wherein the clamping component comprises a first clamping component and a second clamping component, the first clamping component has at least two first clamping arms, the second clamping component has a corresponding number of second clamping arms, each of the first clamping arms and its corresponding second clamping arm form a group of clamps, the first clamping arm and the second clamping arm are arranged at the distal end of the coupling mechanism, the coupling mechanism is a hollow structure, a first connecting structure and a second connecting structure respectively used for connecting with a delivery sheath and a locking mechanism are arranged on the coupling mechanism, the locking mechanism is arranged on the base, and a third connecting structure corresponding to the second connecting structure and a fourth connecting structure used for connecting with a pushing rod are arranged on the locking mechanism, the base is movably connected to the second clamping arm through a connecting rod, and the base can be locked and connected through the third connecting structure on the locking mechanism and the second connecting structure on the coupling mechanism;

[0011] Correspondingly, the first clamping arm and the second clamping arm are made of elastic material, and a fixed angle is set between the first clamping arms, and an angle of 0°-300° can be formed between the second clamping arms;

[0012] Correspondingly, a threading hole is provided on the end of the free end of the first clamping arm, and a pull wire is respectively passed through the threading hole, and the closing of the first clamping arm can be controlled separately by the pull wire. When the first clamping arm needs to restore its fixed angle so as to capture the target tissue, the pulling force of the pull wire on the first clamping arm can be released;

[0013] Correspondingly, a rough structure is provided on one side of the first clamping arm relative to the second clamping arm, and the rough structure includes a tooth-like structure, a barb structure or a protrusion structure, and a groove structure is provided on one side of the second clamping arm relative to the first clamping arm. The first clamping arm can better capture and clamp the target tissue in the groove structure of the second clamping arm through the rough structure, thereby improving the clamping force of the clamping component on the target tissue.

[0014] Correspondingly, the length of the tooth-like structure, barb structure or protrusion structure gradually shortens from the proximal free end to the distal free end;

[0015] Correspondingly, the end of the free end of the second clamping arm is configured as a rounded corner, so as to reduce damage to the tissue caused by the end of the second clamping arm;

[0016] Correspondingly, the first connection structure includes a first wavy curve wall axially arranged at the proximal end of the coupling mechanism and a second wavy curve wall arranged at the distal end of the delivery sheath, and the first wavy curve wall and the second wavy curve wall are arranged correspondingly; they are used to limit the axial displacement of the connection between the coupling mechanism and the delivery sheath. When a push rod is inserted into the delivery sheath and the coupling mechanism, the push rod limits the radial displacement between the coupling mechanism and the delivery sheath, thereby ensuring the stability of the connection between the coupling mechanism and the delivery sheath. After the push rod is withdrawn, the wavy curve walls can be radially displaced first and then axially displaced, thereby realizing the dissociation between the coupling mechanism and the delivery sheath.

[0017] Correspondingly, the first connecting structure includes a first protrusion and a connecting head arranged on the outer side wall of the coupling mechanism, the connecting head includes a hollow connecting seat and an arc-shaped groove wall arranged on the connecting seat, the connecting seat is arranged at the distal end of the conveying sheath, the arc-shaped groove wall is made of elastic material and is shaped into a flared shape, a first notch is arranged on the arc-shaped groove wall, and a relative connecting piece is arranged on the inner side of the arc-shaped groove wall, and a hole is arranged on the connecting piece for the convenience of the push rod to pass through; when the push rod passes through the hole, the distance between the arc-shaped groove walls is shortened, so that the arc-shaped groove walls are wrapped around the outer side wall of the coupling mechanism, and the first protrusion is thereby stuck in the first notch, thereby realizing a stable connection between the coupling mechanism and the conveying sheath, after the push rod is withdrawn, the arc-shaped groove wall restores its flared shape, and then drives the first notch to move away from the outside, so that the first protrusion is disengaged from the first notch, thereby realizing the dissociation between the coupling mechanism and the conveying sheath, and because the connecting head is arranged on the conveying sheath, it is withdrawn from the body with the conveying sheath after the clamping is completed, and does not remain in the body;

[0018] Correspondingly, the first connection structure includes a second notch arranged on the outer side wall of the coupling mechanism and at least two elastic arms made of elastic material and shaped to be close to the center, the elastic arm is arranged at the distal end of the conveying sheath, and a second protrusion is arranged on the elastic arm; when the push rod passes through the conveying sheath and the coupling mechanism, the elastic arm is supported outwardly, thereby driving the second protrusion thereon to be clamped into the second notch, thereby realizing a stable connection between the coupling mechanism and the conveying sheath; after the push rod is withdrawn, the elastic arm restores its close state, and then drives the second protrusion to disengage from the second notch, thereby realizing the dissociation between the coupling mechanism and the conveying sheath; because the elastic arm is arranged on the conveying sheath, it is withdrawn from the body with the conveying sheath after the clamping is completed, and does not remain in the body;

[0019] Correspondingly, the second connection structure includes a first bayonet arranged on the side wall of the coupling mechanism, the third connection structure includes a first base, a first spring sheet, a clamping piece and a first clamping block, the first base is a hollow structure, and its distal end is arranged on the base, the fourth connection structure is arranged on the inner side wall of the first base, and the fourth connection structure includes an internal thread, the first spring sheet is made of elastic material and is shaped into an outwardly inclined shape, which is arranged on the proximal end of the first base, and the clamping piece and the first clamping block are respectively arranged on the inner side wall and the outer side wall of the first spring sheet, and the clamping piece A through hole is provided on the top for the push rod to pass through; when the push rod passes through the through hole, the first spring sheet is pulled into the hollow structure of the coupling mechanism through the clamping piece, and the capture state of the second clamping arm on the target tissue is adjusted by pushing and pulling the push rod. When the ideal capture position is found, the push rod and the first base spirally dissociate and withdraw from the through hole. After the limiting force of the push rod on the first spring sheet is removed, the first spring sheet expands outward to restore its stereotyped shape, and then drives the first clamping block thereon to be clamped into the first clamping port, thereby realizing the locking between the locking mechanism and the coupling mechanism, and then locking the clamping state of the current clamping component on the target tissue;

[0020] Correspondingly, the second connection structure includes a second bayonet arranged on the side wall of the coupling mechanism, the second bayonet includes a vertical bayonet and a horizontal bayonet, the third connection structure includes a hollow lower card platform and a hollow upper card platform, the distal end of the lower card platform is arranged on the base, the proximal end of the lower card platform is provided with a groove, the distal end of the upper card platform is provided with an undercut corresponding to the groove, and a second card block is provided on the outer side wall of the upper card platform, in addition, the inner side walls of the lower card platform and the upper card platform are provided with the fourth connection structure, and the fourth connection The structure includes an internal thread; the undercut is clamped in the clamping groove to realize the clamping connection between the upper clamping platform and the lower clamping platform. When the push rod is not disengaged from the locking mechanism, the push rod can be freely pushed and pulled to adjust the capture state of the second clamping arm on the target tissue. When the ideal capture position is found, the push rod and the lower clamping block and the upper clamping block are spirally disengaged, and the second clamping block moves along the vertical clamping mouth as the push rod is pulled outward, and then is clamped into the horizontal clamping mouth as the push rod spirally disengages, thereby realizing the locking between the locking mechanism and the coupling mechanism, and then locking the clamping state of the current clamping component on the target tissue.

[0021] Correspondingly, the second connecting structure includes a card window and a limiting protrusion arranged on the side wall of the coupling mechanism, the card window includes a first card window and a second card window located on both sides of the limiting protrusion, the third connecting structure includes a torsion spring, a hollow upper end block and a hollow lower end block, the proximal end of the torsion spring is arranged on the side wall of the coupling mechanism, the distal end of the torsion spring is connected to the proximal end of the upper end block, the distal end of the upper end block is axially provided with a third wavy curve wall, the proximal end of the lower end block and the third wavy curve wall are correspondingly provided with a fourth wavy curve wall, the distal end of the lower end block is arranged on the base, a limiting block is arranged on the outer side wall of the upper end block, and the limiting block can move in the first card window along the height direction of the first card window, and cannot move in the first card window along the width direction of the first card window, and can move in the second card window along the width direction of the second card window, and cannot move in the second card window along the first card window. The second card window is movable in the height direction, and the inner side walls of the upper end block and the lower end block are provided with the fourth connecting structure, and the fourth connecting structure includes an internal thread; when the push rod is not disengaged from the locking mechanism, the limit block is limited in the first card window by the limit protrusion, so that the third wavy curve wall and the fourth wavy curve wall are in an un-engaged state, and the push rod can be freely pushed and pulled to adjust the capture state of the second clamping arm on the target tissue. When the ideal capture position is found, the push rod and the lower end block and the upper end block are spirally dissociated. During the dissociation and withdrawal of the push rod, the spiral dissociation of the push rod will drive the upper end block to move radially, and then drive the limit block to move along the height direction of the first card window, thereby crossing the limiting height of the limiting protrusion. Under the action of the torsion force of the torsion spring, the limit block is clamped into the second card window, and at the same time, the third wavy curve wall and the fourth wavy curve wall are clamped, so as to realize the locking between the locking mechanism and the coupling mechanism, and then lock the clamping state of the current clamping component on the target tissue;

[0022] Correspondingly, the second connecting structure includes a second spring sheet arranged on the coupling mechanism, the second spring sheet is made of elastic material and is shaped into a shape inclined toward the inside of the coupling mechanism, a pull rope is passed through the second spring sheet, the third connecting structure includes a hollow second base, the second base has a rough outer wall, and its distal end is arranged on the base, and the fourth connecting structure is arranged on the inner wall of the second base, and the fourth connecting structure includes an internal thread; pull up the pull rope, and adjust the capture state of the second clamping arm on the target tissue by pushing and pulling the push rod. When the ideal capture position is found, the push rod and the second base spirally dissociate and withdraw, and the pull rope is lowered. The second spring sheet restores its inwardly inclined fixed shape and frictionally locks with the rough outer wall of the second base to achieve locking between the locking mechanism and the coupling mechanism, and then locks the clamping state of the current clamping component on the target tissue.

[0023] It should be noted that, in the present invention, the concepts of "proximal end" and "distal end" refer to the relative position between the prosthesis and the operator during normal use during valve surgery. The proximal end refers to the end close to the operator, and the distal end refers to the end away from the operator. The "stereotype" mentioned above refers to the shape or angle of the structure in the natural structure without external force after the early process. For example, the "stereotype angle" refers to the angle naturally presented between the first clamping arms when there is no external force. The "elastic material" mentioned above refers to a material that deforms an object under force, and returns to its original shape after the force is removed.

[0024] The beneficial effects of the present invention are:

[0025] 1) The clamping angle of the first clamping arm adopts a fixed angle, and the closing angle of the first clamping arm during operation can be adjusted separately by a pull line. The clamping angle of the second clamping arm is adjusted by pushing and pulling the push rod, and the final clamping angle is locked by the connection between the locking mechanism and the coupling mechanism. The first clamping arm and the second clamping arm can be adjusted separately. Compared with clamping arms that all adopt fixed angles or can only be adjusted synchronously, it can capture target tissues of different thicknesses and shapes at a more suitable clamping angle, so that the clamping effect is better;

[0026] 2) By setting a coupling mechanism, the connection and dissociation between the clamp and the delivery sheath are simpler and more convenient. By setting a locking mechanism, the connection and dissociation between the clamp and the push rod are simpler and more convenient. The locking mechanism and the coupling mechanism are connected to each other, thereby realizing the locking of the clamping state of the second clamping arm. The locking is simple and easy to operate, thereby improving the clamping locking efficiency.

[0027] 3) By setting up the coupling mechanism and the locking mechanism, on the one hand, the axial operating space of the clamp is shortened, the operating direction is changed, and the capture and clamping operations are performed from the other side of the valve, namely the atrial surface, thereby reducing the risk of damage to the atrium and chordae tendineae during the surgical operation. On the other hand, the length of the clamp is shortened, making the implanted clamp shorter, reducing the risk of thrombosis, and reducing the possible damage to the heart tissue by the exposed ventricular side components of the clamp. In addition, the valve clamping system adopts the path of delivering the clamp from the atrium after puncturing the atrial septum through the femoral vein, without cutting the intercostal space and puncturing the apex of the heart, and the surgical trauma is smaller. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 It is a schematic diagram of the anatomical structure of the heart;

[0029] In the figure: 1 is the superior vena cava, 2 is the inferior vena cava, 3 is the right atrium, 4 is the tricuspid valve, 5 is the right ventricle, 6 is the pulmonary valve, 7 is the pulmonary artery, 8 is the pulmonary vein, 9 is the left atrium, 10 is the mitral valve, 11 is the left ventricle, 12 is the aortic valve, 13 is the aorta, 14 is the descending aorta, 15 is the oxygenated blood flow direction, and 16 is the deoxygenated blood flow direction;

[0030] FIG2 is a schematic diagram of the surgical mitral valve edge-to-edge suturing technique, wherein 2a is when the mitral valve is closed, and 2b is when the mitral valve is open;

[0031] Figure 3a-3d is a schematic diagram of the three-dimensional structure of the valve clip according to the first embodiment of the present invention;

[0032] Figure 4a is a schematic side structural diagram of the valve clip according to the first embodiment of the present invention;

[0033] Figure 4b It is a structural schematic diagram of the coupling mechanism described in Embodiment 1, Embodiment 2 or Embodiment 3 of the invention;

[0034] Figure 4c It is a structural schematic diagram of the coupling mechanism and the delivery sheath clamping connection described in the first embodiment, the second embodiment or the third embodiment of the present invention;

[0035] Figure 4d is a schematic diagram of the matching structure of the locking mechanism and the coupling mechanism according to the first embodiment of the present invention;

[0036] Figure 5a is a schematic side structural diagram of the valve clipper described in Example 2 of the present invention;

[0037] Figure 5b It is a structural schematic diagram of the upper card platform described in Example 2 of the present invention;

[0038] Figure 5cIt is a schematic diagram of the matching structure of the locking mechanism and the coupling mechanism described in the second embodiment of the present invention;

[0039] Figure 6a is a schematic side structural diagram of the valve clipper described in Example 3 of the present invention;

[0040] Figure 6b , 6c is a schematic structural diagram of the locking mechanism described in Example 3 of the present invention;

[0041] Figure 6d , 6e It is a schematic diagram of the matching structure of the locking mechanism and the coupling mechanism described in the third embodiment of the present invention;

[0042] Figure 7a is a schematic side structural diagram of the valve clipper according to the fourth embodiment of the present invention;

[0043] Figure 7b is a schematic structural diagram of a connector according to a fourth embodiment of the present invention;

[0044] Figure 8a is a schematic side structural diagram of the valve clipper according to the fifth embodiment of the present invention;

[0045] Figure 8b is a schematic structural diagram of the elastic arm according to the fifth embodiment of the present invention;

[0046] In the figure:

[0047] 110, first clamping arm; 111, barb structure; 112, threading hole; 113, pull wire;

[0048] 120, second clamping arm; 121, groove structure; 122, flanged rounded corner;

[0049] 200, coupling mechanism;

[0050] 211, first wavy curve wall; 212, second wavy curve wall;

[0051] 221, connecting seat; 222, arc-shaped groove wall; 223, first notch; 224, connecting piece;

[0052] 231, second notch; 232, elastic arm; 233, second protrusion;

[0053] 240, first bayonet;

[0054] 251, vertical bayonet; 252, horizontal bayonet;

[0055] 261, first card window; 262, second card window; 263, limiting protrusion;

[0056] 271, second spring; 272, pull rope;

[0057] 300, base;

[0058] 400, locking mechanism;

[0059] 411, first base; 412, first spring piece; 413, clamping member; 414, first clamping block;

[0060] 421, lower clamping platform; 422, upper clamping platform; 423, groove; 424, undercut; 425, internal thread; 426, second clamping block;

[0061] 431, torsion spring; 432, upper end block; 433, lower end block; 434, third wave curve wall; 435, fourth wave curve wall; 436, limit block;

[0062] 441, second base;

[0063] 500, connecting rod;

[0064] 600, delivery sheath;

[0065] 700. Push rod. DETAILED DESCRIPTION

[0066] In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise" and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the referred device or element must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as limiting the present invention.

[0067] In addition, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first" and "second" may explicitly or implicitly include one or more of the features. In the description of the present invention, the meaning of "plurality" is two or more, unless otherwise clearly and specifically defined.

[0068] In the present invention, unless otherwise clearly specified and limited, the terms "installed", "connected", "connected", "fixed" and the like should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be an indirect connection through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0069] In one embodiment of the present invention, the valve clip includes a clip component, a coupling mechanism 200, a base 300 and a locking mechanism 400;

[0070] like Figure 3a-3dAs shown, the clamping part includes a first clamping part and a second clamping part, the first clamping part has two first clamping arms 110, the second clamping part has a corresponding number of second clamping arms 120, and each first clamping arm 110 and its corresponding second clamping arm 120 form a set of clamps. The first clamping arm 110 and the second clamping arm 120 are made of elastic material, such as nickel-titanium alloy, wherein the first clamping arm 110 can be fixedly arranged on the coupling mechanism 200 by welding or the like, and the second clamping arm 120 can be rotatably arranged on the coupling mechanism 200, for example, by hinged manner. A fixed angle is set between the first clamping arms 110, which is the angle when the target tissue is captured and clamped. A threading hole 112 is set on the free end of the first clamping arm 110, and a pull line 113 is respectively passed through the threading hole 112. During the process of conveying the clamp or capturing the target tissue, the angle between the first clamping arms 110 can be individually controlled by the pull line 113. For example, in order to facilitate the contraction and conveying of the first clamping arm 110, the pull line 113 can be tightened so that the first clamping arm 110 is vertically arranged on the coupling mechanism 200 to minimize the required conveying tube diameter. The push rod 700 is pushed and pulled to drive the locking mechanism 400 and the base 300 fixed to the locking mechanism 400 to move, and the movement of the base 300 drives the second clamping arm 120 to open or close with the help of the connecting rod 500, so that the second clamping arm 120 can form an angle of 0°-300°. In addition, a rough structure is provided on one side of the first clamping arm 110 relative to the second clamping arm 120, and the rough structure includes a tooth-like structure, a barb structure 111 or a protrusion structure, and the length of the tooth-like structure, the barb structure 111 or the protrusion structure gradually shortens from the free end of the first clamping arm 110 to the free end of the first clamping arm 110. A groove structure 121 is provided on one side of the second clamping arm 120 relative to the first clamping arm 110. The first clamping arm 110 can better capture and clamp the target tissue in the groove structure 121 of the second clamping arm 120 through the rough structure, thereby improving the clamping force of the clamping component on the target tissue. The end of the free end of the second clamping arm 120 is set as a flanged rounded corner 122, so as to reduce the damage of the end of the second clamping arm 120 to the tissue;

[0071] The coupling mechanism 200 is a hollow structure, and a first connection structure and a second connection structure are respectively provided on the coupling mechanism 200 for connecting with the delivery sheath 600 and the locking mechanism 400. The locking mechanism 400 is provided on the base 300, and a third connection structure corresponding to the second connection structure and a fourth connection structure for connecting with the push rod 700 are provided on the locking mechanism 400;

[0072] In one embodiment of the present invention, Figures 4a-4dAs shown, the first connection structure includes a first wavy wall 211 axially arranged at the proximal end of the coupling mechanism 200 and a second wavy wall 212 axially arranged on the distal end of the delivery sheath 600. The first wavy wall 211 and the second wavy wall 212 are arranged correspondingly, and the connection between the coupling mechanism 200 and the delivery sheath 600 is realized by the snap-fitting of the first wavy wall 211 and the second wavy wall 212. Of course, for the convenience of operation, the distal end of the delivery sheath 600 is usually directly set as a wavy wall. In this case, the second wavy wall 212 can be regarded as a docking structure arranged on the delivery sheath 600. In another embodiment of the present invention, as Figure 7a and 7b As shown, the first connection structure includes a first protrusion and a connector provided on the outer wall of the coupling mechanism 200, and the connector includes a hollow connection seat 221 and an arcuate groove wall 222 provided on the connection seat 221. The connection seat 221 is provided at the distal end of the conveying sheath 600. For example, the connection seat 221 can be directly fixed on the conveying sheath 600 by welding or the like. Similarly, for the convenience of operation, the connector can be provided on the conveying sheath 600 in an integral or separate manner. In this case, the connector 221 can be regarded as a docking structure provided on the conveying sheath 600. The arcuate groove wall 222 is made of elastic material and is formed into a flared shape. A first notch 223 is provided on the arcuate groove wall 222, and a relative connection piece 224 is provided on the inner side of the arcuate groove wall 222. The connection piece 224 is provided with a hole for the push rod 700 to pass through. In yet another embodiment of the present invention, as Figure 8a and 8b As shown, the first connection structure includes a second notch 231 provided on the outer side wall of the coupling mechanism 200 and at least two elastic arms 232 made of elastic material and shaped to be close to the center. The elastic arm 232 is provided at the distal end of the conveying sheath 600. For example, the elastic arm 232 can be fixedly provided on the conveying sheath 600 by welding or the like. Similarly, for the convenience of operation, the elastic arm 232 can be provided on the conveying sheath 600 in one piece or in a separate piece. In this case, the elastic arm 232 can be regarded as a docking structure provided on the conveying sheath 600, and a second protrusion 233 is provided on the elastic arm 232.

[0073] In one embodiment of the present invention, Figure 4a and 4dAs shown, the second connection structure includes a first bayonet 240 arranged on the side wall of the coupling mechanism 200, and the third connection structure includes a first base 411, a first elastic sheet 412, a clamping member 413 and a first clamping block 414. The first base 411 is a hollow structure, and its distal end is arranged on the base 300. The fourth connection structure is arranged on the inner side wall of the first base 411. In this embodiment, the fourth connection structure is arranged as an internal thread. The first elastic sheet 412 is made of elastic material and is shaped into an outwardly inclined shape. It is arranged on the proximal end of the first base 411. The clamping member 413 and the first clamping block 414 are respectively arranged on the inner side wall and the outer side wall of the first elastic sheet 412. The clamping member 413 is provided with a through hole for the push rod 700 to pass through; in another embodiment of the present invention, as Figure 5a , 5b As shown in Figure 5c, the second connection structure includes a second bayonet provided on the side wall of the coupling mechanism 200, the second bayonet includes a vertical bayonet 251 and a horizontal bayonet 252, the third connection structure includes a hollow lower bayonet 421 and a hollow upper bayonet 422, the distal end of the lower bayonet 422 is provided on the base 300, a groove 423 is provided at the proximal end of the lower bayonet 422, an undercut 424 is provided at the distal end of the upper bayonet 421 corresponding to the groove 423, and a second clamping block 426 is provided on the outer side wall of the upper bayonet 422, in addition, a fourth connection structure is provided on the inner side walls of the lower bayonet 421 and the upper bayonet 422, in this embodiment, the fourth connection structure is provided as an internal thread 425; in yet another embodiment of the present invention, as shown in Figure 5c, Figure 6a-6e As shown, the second connection structure includes a card window and a limiting protrusion 263 arranged on the side wall of the coupling mechanism, the card window includes a first card window 261 and a second card window 262 located on both sides of the limiting protrusion 263, and the third connection structure includes a torsion spring 431, a hollow upper end block 432 and a hollow lower end block 433. The proximal end of the torsion spring 431 is arranged on the side wall of the coupling mechanism 200, and the distal end of the torsion spring 431 is connected to the proximal end of the upper end block 432. The distal end of the upper end block 432 is axially provided with a third wavy curve wall 434, and the proximal end of the lower end block 433 and the third wavy curve wall 434 are correspondingly provided with a fourth wavy curve wall 435. The distal end of the lower end block 433 is connected to the proximal end of the upper end block 432. The upper end block 432 is arranged on the base 300, and a limit block 436 is arranged on the outer side wall of the upper end block 432, and the limit block 436 can move in the first card window 261 along the height direction of the first card window 261, and cannot move in the first card window 261 along the width direction of the first card window 261, and can move in the second card window 262 along the width direction of the second card window 262, and cannot move in the second card window 262 along the height direction of the second card window 262, and the inner side walls of the upper end block 432 and the lower end block 433 are provided with a fourth connection structure. In this embodiment, the fourth connection structure is arranged as an internal thread; in another embodiment of the present invention different from the above, as Figure 8a and 8bAs shown, the second connection structure includes a second elastic sheet 271 disposed on the coupling mechanism, the second elastic sheet 271 is made of elastic material and is shaped to be inclined toward the inside of the coupling mechanism 200, and a pull rope 272 is passed through the second elastic sheet 271. The third connection structure includes a hollow second base 441, the second base 441 has a rough outer wall, and its distal end is disposed on the base 300. A fourth connection structure is disposed on the inner wall of the second base 441. In this embodiment, the fourth connection structure is configured as an internal thread;

[0074] The base 300 is movably connected to the second clamping arm 120 via the connecting rod 500 . For example, one end of the connecting rod 500 is hinged to the base 300 , and the other end of the connecting rod 500 is hinged to the second clamping arm 120 .

[0075] According to the aforementioned valve clipper, the following embodiments can be obtained:

[0076] Embodiment 1

[0077] like Figures 4a-4d As shown, the coupling mechanism 200 adopts a method of clamping the corrugated wall and the delivery sheath 600, and at the same time, the locking mechanism 400 adopts a method of locking the coupling mechanism 200 using a first base 411, a first elastic sheet 412, a clamping member 413, a first clamping block 414 and a first bayonet 240;

[0078] The coupling mechanism 200 and the delivery sheath 600 are anastomosed and connected by using the first wavy curve wall 211 and the second wavy curve wall 212. The coupling mechanism 200 and the delivery sheath 600 cannot be directly axially displaced. Thereafter, the push rod 700 passes through the delivery sheath 600, the coupling mechanism 200 and the through hole in turn and is threadedly connected to the first base 411. The push rod 700 limits the radial displacement between the coupling mechanism 200 and the delivery sheath 600, thereby ensuring the stability of the connection between the coupling mechanism 200 and the delivery sheath 600. At the same time, the push rod 700 uses the clamping piece 413 to tilt the outwardly inclined first spring piece 412 inwardly into the hollow structure of the coupling mechanism 200. In this state, the push rod 700 can be pushed and pulled freely, so that the locking mechanism 400 moves in the coupling mechanism 200. The push and pull of the push rod 700 drives the movement of the locking mechanism 400 and the base 300 fixed to the first base 411. The movement of the base 300 drives the second clamping arm 120 to open or close through the connecting rod 500. Similarly, the rotation of the second clamping arm 120 can also be driven by rotating the push rod 700. When the second clamping arm 120 finds a suitable capture clamping position, the locking mechanism 400 is pulled to a position convenient for locking with the coupling mechanism 200 by means of the push rod 700, and the push rod 700 is rotated in the opposite direction to release the threaded connection between the push rod 700 and the first base 411 and withdraw the push rod 700. After the limiting force of the push rod 700 on the first elastic sheet 412 is removed, the first elastic sheet 412 is outwardly inclined to restore its fixed shape, and then drives the first clamping block 414 thereon to clamp into the first clamping port 240, so as to achieve the locking between the locking mechanism 400 and the coupling mechanism 200, and then lock the clamping state of the current clamping component on the target tissue. At the same time, the withdrawal of the push rod 700 makes the first wavy wall 211 and the second wavy wall 212 lack radial restriction, so the first wavy wall 211 and the second wavy wall 212 can be radially displaced, and the coupling mechanism 200 and the delivery sheath 600 are dissociated and withdrawn from the delivery sheath 600 through radial dislocation and axial displacement, so that the clamp can be implanted in the patient's body alone.

[0079] Embodiment 2

[0080] like Figure 5a-5c As shown, the coupling mechanism 200 adopts a method of clamping the wave-shaped wall and the delivery sheath 600, and at the same time, the locking mechanism 400 adopts a method of locking the coupling mechanism 200 using a lower clamping platform 421, an upper clamping platform 422 and a second clamping port;

[0081] The upper clamping platform 422 and the lower clamping platform 421 are clamped in the clamping groove 423 by means of the undercut 424, and the coupling mechanism 200 and the conveying sheath 600 are matched and clamped by means of the first wavy curve wall 211 and the second wavy curve wall 212. The coupling mechanism 200 and the conveying sheath 600 cannot be directly axially displaced. Thereafter, the push rod 700 passes through the conveying sheath 600, the coupling mechanism 200 and is threadedly connected with the upper clamping platform 422 and the lower clamping platform 421 in turn. The push rod 700 limits the radial displacement between the coupling mechanism 200 and the conveying sheath 600, thereby ensuring the stability of the connection between the coupling mechanism 200 and the conveying sheath 600. In view of the fact that the outer diameters of the upper clamping platform 422 and the lower clamping platform 421 are both smaller than the inner diameter of the conveying sheath 600, the push rod 700 can be freely pushed and pulled in this state, so that the locking mechanism 400 moves in the coupling mechanism 200. The pushing and pulling of the pushing rod 700 drives the locking mechanism 400 and the base 300 fixed to the lower clamping table 421 to move. The movement of the base 300 drives the opening or closing of the second clamping arm 120 through the connecting rod 500. Similarly, the rotation of the second clamping arm 120 can also be driven by rotating the pushing rod 700. When the second clamping arm 120 finds a suitable capture clamping position, it ensures that the second clamping block 426 is in a position where it can move along the vertical clamping slot 251, and the push rod 700 is rotated in the opposite direction to release the threaded connection between the push rod 700 and the lower clamping platform 421 and the upper clamping platform 422 in turn and withdraw the push rod 700. More specifically, the push rod 700 first spirally releases the connection with the lower clamping platform 421. During the spiral process, the upper clamping platform 422 will be driven to move a certain distance until the second clamping block 426 is clamped in the extreme position of the vertical clamping slot 251. As the push rod 700 and the upper clamping platform 422 rotate in the dissociation direction, the second clamping block 426 is clamped into the horizontal clamping slot 252, thereby realizing the locking between the locking mechanism 400 and the coupling mechanism 200, and then locking the clamping state of the current clamping component on the target tissue. At the same time, the withdrawal of the push rod 700 makes the first wavy wall 211 and the second wavy wall 212 lack radial restriction, so the first wavy wall 211 and the second wavy wall 212 can be radially displaced, and the coupling mechanism 200 and the delivery sheath 600 are dissociated and withdrawn from the delivery sheath 600 through radial dislocation and axial displacement, so that the clamp can be implanted in the patient's body alone.

[0082] Embodiment 3

[0083] like Figure 6a-6e As shown, the coupling mechanism 200 adopts a method of clamping the wave-shaped wall and the delivery sheath 600, and at the same time, the locking mechanism 200 adopts a method of locking the coupling mechanism 200 using a torsion spring 431, an upper end block 432, a lower end block 433 and a clamping window and a limiting protrusion 263;

[0084] The first wavy curve wall 211 and the second wavy curve wall 212 are used to anastomose and clamp the coupling mechanism 200 and the conveying sheath 600, and axial displacement cannot occur directly between the coupling mechanism 200 and the conveying sheath 600. Thereafter, the push rod 700 passes through the conveying sheath 600, the coupling mechanism 200, and is threadedly connected with the upper end platform 432 and the lower end platform 433 in sequence. In addition, the limiting protrusion 263 is located in the first clamping window 261, so that the third wavy curve wall 434 and the fourth wavy curve wall 435 are in an unclamped state. In view of the fact that the outer diameters of the upper end platform 432 and the lower end platform 433 and the axial outer diameter of the torsion spring 431 are all smaller than the inner diameter of the conveying sheath 600, therefore, in this state, the push rod 700 can be freely pushed and pulled, so that the locking mechanism 400 moves in the coupling mechanism 200 within the height limit of the first clamping window 261. The pushing and pulling of the pushing rod 700 drives the locking mechanism 400 and the base 300 fixed to the lower end platform 433 to move. The movement of the base 300 drives the opening or closing of the second clamping arm 120 through the connecting rod 500. Similarly, the rotation of the second clamping arm 120 can also be driven by rotating the pushing rod 700 within the width limit of the first card window 261. When the second clamping arm 120 finds a suitable capture clamping position, the push rod 700 is rotated in the opposite direction to release the threaded connection between the push rod 700 and the lower end platform 433 and the upper end platform 432 in turn and withdraw the push rod 700. More specifically, the push rod 700 first spirally releases the connection with the lower end platform 433. During the spiral process, the upper end platform 432 will be driven to move a certain distance, and then the limit block 436 will be driven to move along the height direction of the first card window 261, thereby exceeding the limit height of the limit protrusion 263. Under the action of the torsion force of the torsion spring 431, the limit block 436 is clamped into the second card window 262, and at the same time, the third wavy curve wall 434 and the fourth wavy curve wall 435 are clamped, thereby realizing the locking between the locking mechanism 400 and the coupling mechanism 200, and then locking the clamping state of the current clamping component on the target tissue. At the same time, the withdrawal of the push rod 700 makes the first wavy wall 211 and the second wavy wall 212 lack radial restriction, so the first wavy wall 211 and the second wavy wall 212 can be radially displaced, and the coupling mechanism 200 and the delivery sheath 600 are dissociated and withdrawn from the delivery sheath 600 through radial dislocation and axial displacement, so that the clamp can be implanted in the patient's body alone.

[0085] Embodiment 4

[0086] like Figure 7a and 7b As shown, the coupling mechanism 200 adopts a clamping method of the first protrusion, the connector and the delivery sheath 600, and at the same time, the locking mechanism 400, the coupling mechanism 200 and the push rod 700 adopt any one of the above three embodiments;

[0087] The connection seat 221 of the connector is set at the distal end of the conveying sheath 600 by welding, sleeve connection or integral mold, and the push rod 700 passes through the conveying sheath 600, the coupling mechanism 200 and the channel in sequence, shortening the distance between the arc groove wall 222, so that the arc groove wall 222 is wrapped on the outer wall of the coupling mechanism 200, and the first protrusion is thus inserted into the first notch 223, thereby realizing a stable connection between the coupling mechanism 200 and the conveying sheath 600. After the push rod 700 is withdrawn, the arc groove wall 222 restores its flared shape, and then drives the first notch 223 away from the outside, so that the first protrusion is disengaged from the first notch 223, thereby realizing the dissociation between the coupling mechanism 200 and the conveying sheath 600. Because the connector is set on the conveying sheath 600, it is withdrawn from the body with the conveying sheath 600 after the clamping is completed, and does not remain in the body. Since the connection and dissociation between the locking mechanism 400, the coupling mechanism 200 and the pushing rod 700 have been described in the first three embodiments, they will not be repeated in this embodiment.

[0088] Embodiment 5

[0089] like Figure 8a and 8b As shown, the coupling mechanism 200 adopts a clamping method of the second notch 231, the elastic arm 232, the second protrusion 233 and the delivery sheath 600, and at the same time, the locking mechanism 400 adopts a second base 441 and a coupling mechanism 200 using a second elastic sheet 271 and a pull rope 272 for locking;

[0090] The elastic arm 232 is set at the far end of the conveying sheath 600 by welding, sleeve connection or integral molding, and the push rod 700 passes through the conveying sheath 600 and the coupling mechanism 200 in turn, and is threadedly connected with the second base 441. When the push rod 700 passes through the conveying sheath 600 and the coupling mechanism 200, the elastic arm 232 is supported outward, thereby driving the second protrusion 233 thereon to be stuck in the second groove 231, so as to achieve a stable connection between the coupling mechanism 200 and the conveying sheath 600, and pull the pull rope 272. In this state, the second spring piece 271 does not have friction clamping on the second base 441, and the push rod 700 can be pushed and pulled freely, so that the locking mechanism 400 moves in the coupling mechanism 200. The push and pull of the push rod 700 drives the movement of the locking mechanism 400 and the base 300 fixed to the second base 441. The movement of the base 300 drives the second clamping arm 120 to open or close through the connecting rod 500. Similarly, the rotation of the second clamping arm 120 can also be driven by rotating the push rod 700. When the second clamping arm 120 finds a suitable capture clamping position, the push rod 700 is rotated in the opposite direction to release the threaded connection between the push rod 700 and the second base 441 in turn and withdraw the push rod 700, loosen the pull rope 272, so that the second elastic sheet 271 returns to its fixed shape, clamps the second base 441 by friction, realizes the locking between the locking mechanism 400 and the coupling mechanism 200, and then locks the clamping state of the current clamping component on the target tissue. At the same time, after the push rod 700 is withdrawn, the elastic arm 232 returns to its closed state, and then drives the second protrusion 233 to disengage from the second groove 231, thereby realizing the dissociation of the coupling mechanism 200 and the delivery sheath 600. Because the elastic arm 232 is arranged on the delivery sheath 600, it is withdrawn from the body with the delivery sheath 600 after the clamping is completed, and does not remain in the body. The remaining clamps are implanted separately in the patient's body.

[0091] In addition, it should be specially explained that the delivery sheath 600 and the push rod 700 are both delivery devices for delivering valve clamps that are well known in the technical field. Of course, in addition to the two delivery structures of the delivery sheath 600 and the push rod 700, the delivery device also includes other commonly used structures, such as a catheter sheath and a loader, etc. In view of the fact that there is no direct connection between the remaining structures in the delivery device and the clamp involved in the present invention, no further explanation will be given.

[0092] The preferred specific embodiments of the present invention are described in detail above. It should be understood that a person skilled in the art can make many modifications and changes based on the concept of the present invention without creative work. Therefore, any technical solution that can be obtained by a person skilled in the art through logical analysis, reasoning or limited experiments based on the concept of the present invention on the basis of the prior art should be within the scope of protection determined by the claims.

Claims

1. A valve clamp, comprising a clamping member, a coupling mechanism, a base and a locking mechanism, It is characterized in that The clamping component includes a first clamping component and a second clamping component, the first clamping component has at least two first clamping arms, the second clamping component has a corresponding number of second clamping arms, each of the first clamping arms and its corresponding second clamping arm form a group of clamps, the first clamping arm and the second clamping arm are arranged at the distal end of the coupling mechanism, the coupling mechanism is a hollow structure, and a first connecting structure and a second connecting structure respectively used for connecting with the delivery sheath and the locking mechanism are arranged on the coupling mechanism, the locking mechanism is arranged on the base, and a third connecting structure corresponding to the second connecting structure and a fourth connecting structure used for connecting with the pushing rod are arranged on the locking mechanism, the base is movably connected to the second clamping arm through the connecting rod, and the base can be locked and connected through the third connecting structure on the locking mechanism and the second connecting structure on the coupling mechanism; The first connection structure includes a first wavy curve wall axially arranged at the proximal end of the coupling mechanism and a second wavy curve wall arranged on the distal end of the delivery sheath, and the first wavy curve wall and the second wavy curve wall are arranged correspondingly; or, the first connection structure includes a first protrusion and a connector arranged on the outer side wall of the coupling mechanism, the connector includes a hollow connection seat and an arc-shaped groove wall arranged on the connection seat, the connection seat is arranged at the distal end of the delivery sheath, the arc-shaped groove wall is made of elastic material and is shaped into a flared shape, a first notch is arranged on the arc-shaped groove wall, and a relative connecting piece is arranged on the inner side of the arc-shaped groove wall, and a hole is arranged on the connecting piece to facilitate the passage of the push rod; The second connection structure includes a first bayonet disposed on the side wall of the coupling mechanism, the third connection structure includes a first base, a first spring sheet, a clamping piece and a first clamping block, the first base is a hollow structure, and its distal end is disposed on the base, the fourth connection structure is disposed on the inner side wall of the first base, the fourth connection structure includes an internal thread, the first spring sheet is made of elastic material and is shaped to be inclined outward, and is disposed on the proximal end of the first base, and the clamping piece and the first clamping block are disposed on the inner side wall and the outer side wall of the first spring sheet, respectively. The clamping member is provided with a through hole for the push rod to pass through; or, the second connecting structure includes a second clamping socket provided on the side wall of the coupling mechanism, the second clamping socket includes a vertical clamping socket and a horizontal clamping socket, the third connecting structure includes a hollow lower clamping platform and a hollow upper clamping platform, the distal end of the lower clamping platform is provided on the base, the proximal end of the lower clamping platform is provided with a groove, the distal end of the upper clamping platform is provided with an undercut corresponding to the groove, and a second clamping block is provided on the outer side wall of the upper clamping platform, and the inner side walls of the lower clamping platform and the upper clamping platform are provided with the fourth connecting structure , the fourth connection structure includes an internal thread; or, the second connection structure includes a card window and a limiting protrusion arranged on the side wall of the coupling mechanism, the card window includes a first card window and a second card window located on both sides of the limiting protrusion, the third connection structure includes a torsion spring, a hollow upper end block and a hollow lower end block, the proximal end of the torsion spring is arranged on the side wall of the coupling mechanism, the distal end of the torsion spring is connected to the proximal end of the upper end block, the distal end of the upper end block is axially provided with a third wavy curve wall, the proximal end of the lower end block and the third wavy curve wall are correspondingly provided A fourth wave-curved wall is disposed, the distal end of the lower end block is disposed on the base, a limiting block is disposed on the outer side wall of the upper end block, and the inner side walls of the upper end block and the lower end block are provided with the fourth connecting structure, and the fourth connecting structure includes an internal thread; the limiting block can move in the first card window along the height direction of the first card window, but cannot move in the first card window along the width direction of the first card window, and can move in the second card window along the width direction of the second card window, but cannot move in the second card window along the height direction of the second card window; Or: the first connecting structure includes a second notch arranged on the outer side wall of the coupling mechanism and at least two elastic arms made of elastic material and shaped to be close to the center, the elastic arm is arranged at the distal end of the conveying sheath, and a second protrusion is arranged on the elastic arm; and the second connecting structure includes a second elastic sheet arranged on the coupling mechanism, the second elastic sheet is made of elastic material and shaped to be inclined toward the inside of the coupling mechanism, a pull rope is passed through the second elastic sheet, the third connecting structure includes a hollow second base, the second base has a rough outer side wall, and its distal end is arranged on the base, the fourth connecting structure is arranged on the inner side wall of the second base, and the fourth connecting structure includes an internal thread.

2. A valve clip according to claim 1, It is characterized in that The first clamping arm and the second clamping arm are made of elastic material, and a fixed angle is set between the first clamping arms, and an angle of 0°-300° can be formed between the second clamping arms.

3. A valve clip according to claim 1, It is characterized in that A threading hole is arranged on the end of the free end of the first clamping arm, and pull wires are respectively passed through the threading holes.

4. The valve clip according to claim 1, It is characterized in that A rough structure is provided on one side of the first clamping arm opposite to the second clamping arm, and the rough structure is a tooth-shaped structure. A groove structure is provided on one side of the second clamping arm opposite to the first clamping arm.

5. The valve clip according to claim 1, It is characterized in that A rough structure is provided on one side of the first clamping arm opposite to the second clamping arm, and the rough structure is a barb structure. A groove structure is provided on one side of the second clamping arm opposite to the first clamping arm.

6. The valve clip according to claim 1, It is characterized in that A rough structure is provided on one side of the first clamping arm relative to the second clamping arm, and the rough structure is a convex structure, and a groove structure is provided on one side of the second clamping arm relative to the first clamping arm.

7. A valve clip according to any one of claims 4 to 6, It is characterized in that The length of the rough structure gradually shortens from the near free end to the far free end.

8. The valve clip according to claim 1, It is characterized in that The end of the free end of the second clamping arm is configured as a flanged rounded corner.

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