Valve clipping device with locking mechanism and valve repair system

Abstract

The present invention discloses a valve clamping device with a locking mechanism and a valve repair system, wherein the valve clamping device includes a fixed base, at least one pair of clamp arms, a drive assembly, and a locking mechanism, wherein the at least one pair of clamp arms is connected to the fixed base and can be opened and closed relative to the fixed base; the drive assembly includes a drive shaft movably inserted into the fixed base, the drive shaft moves axially to drive the clamp arms to open and close relative to the fixed base, and the outer peripheral surface of the drive shaft is provided with a positioning portion; the locking mechanism includes a locking member and a push member, the locking member has a locking hole axially provided, the drive shaft is inserted into the locking hole, and the push member pushes against the locking member and is obliquely arranged in the fixed base so that the edge of the locking hole is engaged with the positioning portion. The locking mechanism of the present invention can increase the friction and mechanical bite force between the drive shaft and the locking member, prevent the edge of the locking hole of the locking member from being locally stressed and worn, improve the fatigue resistance of the valve clamping device, improve the locking stability, and prevent locking failure.

Description

Technical Field

[0001] The present invention relates to the field of interventional medical devices, and in particular to a valve clamping device with a locking mechanism and a valve repair system. Background Art

[0002] See also Figure 1 The mitral valve 1 is a one-way valve located between the left atrium 2 and the left ventricle 3 of the heart. A healthy mitral valve 1 controls blood flow from the left atrium 2 to the left ventricle 3 while preventing blood from flowing from the left ventricle 3 back to the left atrium 2. The mitral valve 1 consists of a pair of leaflets, called the anterior leaflet 1a and the posterior leaflet 1b. The anterior leaflet 1a and the posterior leaflet 1b are fixed to the papillary muscles of the left ventricle 3 by chordae tendineae 4. Under normal circumstances, when the heart contracts, the edges of the anterior leaflet 1a and the posterior leaflet 1b completely close together, preventing blood from flowing from the left ventricle 3 to the left atrium 2. Figure 2 When the leaflets of the mitral valve 1 or its related structures undergo organic or functional changes, such as partial rupture of the chordae tendineae 4, the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1 are poorly aligned. As a result, when the heart contracts, the mitral valve 1 cannot close completely, causing blood to flow back from the left ventricle 3 to the left atrium 2, thereby causing a series of pathophysiological changes, called "mitral regurgitation."

[0003] Mitral regurgitation is commonly treated with surgical procedures such as edge-to-edge suturing. However, these procedures are associated with complex procedures, high costs, high patient trauma, a high risk of complications, prolonged hospital stays, and a painful recovery process. A minimally invasive treatment device, based on the principle of edge-to-edge suturing, delivers a valve clip to the mitral valve via an interventional catheter. The clip then opens and closes, simultaneously grasping the anterior and posterior leaflets of the mitral valve, pulling the leaflets toward each other, reducing the intercuspal gap and treating mitral regurgitation.

[0004] A valve clip with a locking mechanism currently exists. The locking mechanism includes a wedge-shaped element and a metal frame that overlaps the wedge-shaped element. The wedge-shaped element has a through-hole in the middle, through which the valve clip drive shaft passes. When the metal frame is pulled proximally, one end of the wedge-shaped element is pulled while the other end remains stationary, thereby reducing friction between the drive shaft and the through-hole and allowing the drive shaft to move within the through-hole. However, due to the smooth surface of the drive shaft and the inner surface of the through-hole of the wedge-shaped element, the friction between the two is low, resulting in a low locking force. This can lead to wear, slippage, or failure of the locking mechanism, resulting in premature opening of the valve clip during delivery, accidental opening during the process of clamping the valve leaflets, or dislodgment of the valve clip after implantation, resulting in surgical failure or even serious harm to the patient's life and health. Summary of the Invention

[0005] In view of this, the present invention provides a valve clamping device with a locking mechanism, which can improve the locking force of the locking mechanism, prevent locking failure, and improve the safety and fatigue resistance of the valve clamping device.

[0006] In order to solve the above technical problems, the present invention provides a valve clamping device with a locking mechanism, comprising a fixed base, at least one pair of clamp arms, a drive assembly, and a locking mechanism, wherein the at least one pair of clamp arms is connected to the fixed base and can be opened and closed relative to the fixed base; the drive assembly comprises a drive shaft movably inserted in the fixed base, the drive shaft moves axially to drive the clamp arms to open and close relative to the fixed base, and the outer peripheral surface of the drive shaft is provided with a positioning portion; the locking mechanism comprises a locking member and a push member, the locking member has a locking hole axially provided, the drive shaft is inserted into the locking hole, and the push member pushes against the locking member obliquely arranged in the fixed base, so that the edge of the locking hole is engaged with the positioning portion.

[0007] The present invention also provides a valve repair system, comprising a valve clamping device and a delivery device detachably connected to the valve clamping device, wherein the delivery device comprises an operating wire, and the distal end of the operating wire is detachably connected to the unlocking control member.

[0008] The outer peripheral surface of the driving shaft of the valve clamping device provided by the present invention is provided with a positioning portion, the driving shaft is inserted into the locking piece, and the pushing piece pushes against the locking piece and is obliquely arranged in the fixed base, so that the edge of the locking hole is clamped on the positioning portion to increase the friction and mechanical bite force between the driving shaft and the locking piece, which can not only prevent the edge of the locking hole of the locking piece from being locally subjected to force and wear, but also the edge of the driving shaft and the locking hole have a certain bite amount, and the two will be more tightly engaged under the action of force. The drive shaft and the edge of the locking hole are not simply matched by friction, which improves the locking force and stability of the locking mechanism and prevents the valve clamping device from failing to lock. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following briefly introduces the drawings required for use in the implementation. Obviously, the drawings described below are some implementations of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0010] Figure 1 This is a schematic diagram of the mitral valve in its normal state.

[0011] Figure 2 This is a schematic diagram of a mitral valve disease.

[0012] Figure 3It is a schematic three-dimensional structural diagram of a valve clamping device with a locking mechanism provided in the first embodiment of the present invention.

[0013] Figure 4 yes Figure 3 Side view of a valve clipping device with a locking mechanism.

[0014] Figure 5 yes Figure 3 Schematic diagram of the three-dimensional structure of the fixed base, part of the driving assembly and the locking mechanism of the valve clamping device.

[0015] Figure 6 yes Figure 5 A side view of the fixed base, part of the drive assembly and the locking mechanism of the valve clamping device in FIG.

[0016] Figure 7 yes Figure 6 Magnified view of part VII.

[0017] Figure 8 Figure 5 The cross-sectional view after the push member and the unlocking control member are omitted.

[0018] Figure 9 yes Figure 8 Magnified view of section IX.

[0019] Figure 10 yes Figure 3 Schematic diagram of the three-dimensional structure of the drive shaft and connecting seat of the valve clamping device.

[0020] Figure 11 yes Figure 5 Schematic diagram of the three-dimensional structure of the locking member.

[0021] Figure 12 yes Figure 5 Schematic diagram of the three-dimensional structure of the push member.

[0022] Figure 13 yes Figure 12 A schematic three-dimensional structural diagram of another embodiment of the push member.

[0023] Figure 14 yes Figure 5 Schematic diagram of the three-dimensional structure of the unlocked state of the locking mechanism of the valve clamping device.

[0024] Figure 15 yes Figure 14 Side view of the unlocked state of the locking mechanism of the valve clipping device.

[0025] Figure 16 yes Figure 15 Magnified view of section XVI.

[0026] Figure 17 yes Figure 5 Schematic diagram of the three-dimensional structure of the unlocking control component.

[0027] Figure 18 yes Figure 17 Side view of the unlock control.

[0028] Figure 19 yes Figure 5 Schematic diagram of the three-dimensional structure of the fixed base, part of the drive assembly, the locking mechanism and the clamping arm.

[0029] Figure 20 yes Figure 19 side view.

[0030] Figure 21 yes Figure 3 Schematic diagram of one of the usage states of the valve clamping device with a locking mechanism.

[0031] Figure 22 yes Figure 3 Schematic diagram of the closed state of the valve clipping device with a locking mechanism.

[0032] Figure 23 It is a schematic three-dimensional structural diagram of a valve clamping device with a locking mechanism provided in a second embodiment of the present invention.

[0033] Figure 24 yes Figure 23 Side view of a valve clipping device with a locking mechanism.

[0034] Figure 25 yes Figure 23 Schematic diagram of the structure of the fixed base, part of the drive assembly and the locking mechanism of the valve clamping device with a locking mechanism.

[0035] Figure 26 yes Figure 25 Partial cross-sectional view of the valve clipping device in FIG.

[0036] Figure 27 yes Figure 26 An enlarged view of section XXVII in FIG.

[0037] Figure 28 3 is a schematic structural diagram of a valve clamping device with a locking mechanism provided in a third embodiment of the present invention.

[0038] Figure 29 2 is a schematic structural diagram of a valve clamping device with a locking mechanism provided in a fourth embodiment of the present invention.

[0039] Figure 30 It is a statistical chart of the performance test results of the valve clamping device of the present invention. DETAILED DESCRIPTION

[0040] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0041] In addition, the following descriptions of the embodiments refer to the accompanying drawings to illustrate specific embodiments in which the present invention may be implemented. Directional terms used in the present invention, such as "upper," "lower," "front," "back," "left," "right," "inner," "outer," and "side," are used solely with reference to the directions in the accompanying drawings. Therefore, the use of directional terms is intended to better and more clearly illustrate and understand the present invention, and is not intended to indicate or imply that the device or component referred to must have a specific orientation, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limiting the present invention.

[0042] In describing the present invention, it is important to note that, in the field of interventional medical devices, the proximal end refers to the end closer to the operator, while the distal end refers to the end farther from the operator. Axial direction refers to the direction parallel to the line connecting the distal and proximal centers of the medical device in its natural state. The above definitions are for convenience only and are not to be construed as limitations of the present invention.

[0043] Please also refer to Figure 3-Figure 9 The first embodiment of the present invention provides a valve repair system, which includes a valve clamping device 100 with a locking mechanism and a delivery device 500 detachably connected to the valve clamping device 100. The valve clamping device 100 includes a fixed base 20, at least one pair of forceps arms 40 hinged to the fixed base 20, a tissue clamping member 60 disposed between the fixed base 20 and the forceps arms 40, a driving assembly 70 for driving the forceps arms 40 to open and close relative to the fixed base 20, and a locking mechanism 80 disposed on the fixed base 20. The at least one pair of forceps arms 40 opens and closes relative to the fixed base 20. The tissue clamping member 60 includes at least one pair of clamping arms 64. After being released, each clamping arm 64 moves toward the forceps arm 40 and cooperates with the forceps arm 40 on the corresponding side to clamp the valve tissue located therebetween.

[0044] Specifically, the drive assembly 70 includes a drive shaft 72 movably inserted into the fixed base 20. The drive shaft 72 moves axially to drive the clamp arm 40 to open and close relative to the fixed base 20. The outer peripheral surface of the drive shaft 72 is provided with a positioning portion 720. The locking mechanism 80 includes a locking member 82 and a push member 84. The locking member 82 has a locking hole 820 defined along the axial direction. The drive shaft 72 is inserted into the locking hole 820. The push member 84 pushes against the locking member 82 and is obliquely disposed in the fixed base 20, so that the edge 281 of the locking hole 820 is engaged with the positioning portion 720, thereby fixing the drive shaft 72 relative to the fixed base 20, thereby limiting the relative opening and closing between the clamp arm 40 and the fixed base 20.

[0045] The delivery device 500 includes a tubular assembly, an operating wire 501 and a control wire 801 which are arranged in the tubular assembly. The operating wire 501 is connected to the clamping arm 64, and the control wire 801 is connected to the locking mechanism 80. The operating wire 501 and the control wire 801 extend outside the patient's body. When in use, the proximal end of the valve clamping device 100 is releasably connected to the distal end of the tubular assembly, and the valve is opened and closed by the operating wire 501 (e.g., Figure 19 and Figure 20The locking member 82 is then pulled away from the locking member 82 by the control wire 801 so that the edge 281 of the locking hole 820 and the driving shaft 72 can move relative to each other, thereby locking the relative movement between the clamp arm 40 and the fixed base 20; then, the locking member 82 is pulled away from the control wire 801 so that the edge 281 of the locking hole 820 and the driving shaft 72 can move relative to each other, and then the locking member 82 applies pressure to the pushing member 84 so that the pushing member 84 is bent and deformed, and then the driving shaft 72 is operated to make the clamp arm 40 retract to the outer surface of the fixed base 20, and then the locking member 82 is released, and the pushing member 84 returns to its initial state and pushes the locking member 82 back to the inclined position on the fixed base 20, and the edge 281 of the locking hole 820 is engaged with the positioning portion 720, and the clamp arm 40 and the fixed base 20 are locked. After the valve clamping device 100 is pushed to the patient's mitral valve and adjusted to the appropriate position, the locking mechanism 80 is unlocked from the drive shaft 72 again, and the drive shaft 72 is operated to open the clamp arm 40 relative to the fixed base 20; the pulling force of the operating wire 501 on the two clamping arms 64 is then released, and the clamping arm 64 rebounds and moves to the clamp arm 40, thereby pressing the leaflet toward the clamp arm 40. When the anterior leaflet and the posterior leaflet of the mitral valve are respectively clamped together by the clamp arm 40 and the corresponding clamp arm 64, the engagement of the locking member 82 with the drive shaft 72 is released, and the drive shaft 72 is operated to close the clamp arm 40 relative to the fixed base 20, thereby pulling the anterior leaflet and the posterior leaflet toward each other, and then the connection between the tubular assembly and the valve clamping device 100 is released, and the delivery device 500 is withdrawn. The valve clamping device 100 remains in the patient's body as an implant to maintain the apposition position of the leaflets together, thereby achieving "edge-to-edge repair" of the mitral valve and alleviating the patient's mitral regurgitation.

[0046] It should be noted that the valve clamping device 100 and the delivery device 500 can be delivered into the patient's body using existing guiding devices such as adjustable bending sheaths and shaping sheaths.

[0047] When the closure 72 is in the closed position, the closure 72 is in the closed position, and the closure 72 is in the closed position, so that the closure 72 is in the closed position and the closure 72 is in the closed position.

[0048] Preferably, the inner diameter of the locking hole 820 of the locking piece 82 is appropriately increased. After the drive shaft 72 is inserted into the locking hole 820, the gap between the outer peripheral surface of the drive shaft 72 and the inner surface of the locking hole 820 will increase; therefore, it can prevent the outer peripheral surface of the drive shaft 72 and the inner surface of the locking hole 820 from interfering with each other due to the overall offset of the locking piece 82 during the unlocking process.

[0049] like Figure 3 and Figure 4 As shown, in this embodiment, the valve clipping device 100 includes a pair of opposing arms 40, each of which can be opened and closed relative to the fixed base 20. Each arm 40 includes a connecting frame 42 and a clamping frame 44 connected to the end of the connecting frame 42 away from the fixed base 20. The ends of the connecting frames 42 of the two arms 40 away from the clamping frame 44 are stacked on top of each other and then hinged to the fixed base 20. A leaflet accommodating space is formed between the clamping arm 64 and the arm 40; specifically, the surface of each arm 40 facing the clamping arm 64 is inwardly recessed to form a receiving groove 45. When the valve clipping device 100 is in the delivery state, the clamping arm 64 is at least partially accommodated in the receiving groove 45 of the arm 40, thereby reducing the outer diameter and volume of the valve clipping device 100 and facilitating delivery within the body. After the clamp arm 40 and the clamping arm 64 cooperate to clamp the leaflet, the leaflet is clamped in the receiving groove 45, which increases the contact area between the clamp arm 40 and the leaflet. The leaflet is pressed into the receiving groove 45 of the clamp arm 40 by the clamping arm 64, which also increases the clamping force on the leaflet 300. The connecting frame 42 extends proximally at one end adjacent to the fixed base 20 and is hinged to the fixed base 20. That is, the connecting frame 42 defines a pin hole for inserting a pin, which is connected to the fixed base 20.

[0050] The forceps arms 40 are driven by the drive assembly 70 to open and close relative to the fixed base 20. The angle between the two forceps arms 40 can reach a maximum of 300 degrees. That is, after the forceps arms 40 are opened relative to the fixed base 20, they can be tilted downward to a certain extent, thereby facilitating the clamping of the moving valve and improving the clamping success rate. If the clamping effect is not satisfactory after clamping, the forceps arms 40 can be tilted downward to loosen the valve leaflets and re-clamp. In this embodiment, the angle between the two forceps arms 40 is preferably in the range of 0-240 degrees, and more preferably 120-180 degrees.

[0051] Preferably, an anti-slip structure (not shown) may be provided on the inner surface of the receiving groove 45 of the clamp arm 40 to enhance the friction between the clamp arm 40 and the valve leaflet, thereby providing a stable clamping force and preventing the clamp arm 40 from damaging the valve leaflet. The anti-slip structure may be a protrusion or groove provided on the inner surface of the receiving groove 45 of the clamp frame 44, or a gasket made of a biocompatible material with a high friction coefficient and attached to the inner surface of the receiving groove 45.

[0052] Preferably, active drugs may be applied on the inner surface of the receiving groove 45 of the forceps arm 40 to promote the endothelial cells of the valve tissue to crawl and grow on the inner surface of the forceps arm 40 and the clamping arm 64 .

[0053] The drive assembly 70 also includes a connecting base 74 disposed at the distal end of the drive shaft 72 and a pair of connecting rods 76 movably connected to either side of the connecting base 74. The drive shaft 72 movably passes through the fixed base 20 and is connected to the connecting base 74. Each connecting rod 76 is connected to a corresponding clamp arm 40 at one end and pivotally connected to the connecting base 74 at the other end. In other words, each clamp arm 40 is pivotally connected to the connecting base 74 of the drive assembly 70 via the corresponding connecting rod 76.

[0054] In this embodiment, the end of the connecting frame 42 of each clamp arm 40, distal from the clamping frame 44, is rotatably connected to the same position on the fixed base 20. The portion of the connecting frame 42 of each clamp arm 40, proximal to the clamping frame 44, is rotatably connected to the proximal end of a connecting rod 76 on the corresponding side. The distal end of the connecting rod 76 is rotatably connected to the connecting seat 74 at the distal end of the drive shaft 72 via a pin or bolt. When the drive shaft 72 slides axially toward the distal end relative to the fixed base 20, it drives the connecting rod 76 to move. Under the pull of the connecting rod 76, the clamp arm 40 rotates about the pin hole and opens relative to the fixed base 20. When the drive shaft 72 slides axially toward the proximal end relative to the fixed base 20, the connecting rod 76 pulls the clamp arm 40 to rotate about the pin hole and close relative to the fixed base 20.

[0055] The connecting seat 74 includes two opposing first flat surfaces and two connecting surfaces connecting the two first flat surfaces. Opposite ends of the connecting seat 74 each include a pair of pin holes extending through the two first flat surfaces. The pin holes are used to connect the clamp arm 40 via a pin hinge. The cross-sectional dimensions of the connecting seat 74 parallel to the second flat surface gradually decrease from the proximal end to the distal end. That is, the connecting seat 74 can be shaped as a hemisphere, a spherical cap, or a bullet, thereby making it easier to push the valve clamping device 100 within the body. The connecting seat 74 and the drive shaft 72 can be integral or non-integrated. In this embodiment, the connecting seat 74 and the drive shaft 72 are non-integrated. The drive shaft 72 is a round rod with an external thread at its distal end. The drive shaft 72 is screwed to the connecting seat 74 and then welded to secure it. In other embodiments, the drive shaft 72 can be fixedly connected to the connecting seat 74 using other detachable or non-detachable connection methods, such as a snap-fit ​​connection.

[0056] The outer circumference of the drive shaft 72 is provided with a positioning portion 720. The positioning portion 720 can be a protruding structure higher than the outer circumference of the drive shaft 72, or a groove structure lower than the outer circumference of the drive shaft 72. In this embodiment, the positioning portion 720 includes a plurality of grooves 722 arranged facing the locking hole 820 of the locking member 82; the edge of the locking hole 820 is embedded in the corresponding groove 722, and the two play a role similar to mechanical bite, which can prevent the edge of the locking hole 820 of the locking plate 82 from being subjected to force and wear, thereby ensuring the stability of the lock. The shape of the groove 722 can be semicircular, rectangular, trapezoidal or triangular. The groove 722 of this embodiment is a semicircular groove structure. The width of the groove 722 should be set in the range of 0.04-0.30 mm, preferably 0.08-0.20 mm. If the width of the groove 722 is too small, the embedding overlap between the two cannot be guaranteed, and there is a possibility of wear and slippage. If the width of the groove 722 is too wide, the degree of closure of the valve clamping device will be affected. Specifically, each groove 722 is provided along the circumference of the drive shaft 72, and a plurality of grooves 722 are arranged axially at the distal end of the drive shaft 72. Preferably, the plurality of grooves 722 are arranged in parallel, that is, evenly spaced along the axial direction of the drive shaft 72.

[0057] In other embodiments, the positioning portion 720 includes a plurality of protrusions disposed toward the locking hole 820 of the locking member 82, with the edges of the locking hole 820 engaging corresponding protrusions. Specifically, each protrusion is a flange disposed along the circumference of the drive shaft 72, with the plurality of flanges arranged axially at the distal end of the drive shaft 72. Preferably, the plurality of flanges are arranged parallel to one another, i.e., evenly spaced along the axial direction of the drive shaft 72. The width of the protrusions ranges from 0.04 to 0.30 mm, preferably from 0.08 to 0.20 mm.

[0058] like Figures 5 to 9As shown, the fixed base 20 includes a rectangular fixed frame 21, a connecting block 22 disposed at the proximal end of the fixed frame 21, clamping blocks 23 disposed on opposite sides of the fixed frame 21, and a boss 25 disposed within the inner cavity of the fixed base 20. The fixed base 20 is provided with a through hole 24 axially extending through the connecting block 22 and the fixed frame 21. The through hole 24 is used to insert the drive shaft 72. Pin holes 26 are respectively provided at opposite ends of the connecting block 22. The axis of the pin holes 26 is perpendicular to the axis of the through hole 24. The pin holes 26 are used to connect to the connecting portion 42 of the clamp arm 40 via a pin. The boss 25 is provided on one side wall of the inner cavity of the fixed frame 21. The proximal end of the boss 25 is provided with a bevel 251. The first end 823 of the locking member 82 abuts the boss 25. A gap 826 is provided between the second end 825 of the locking member 82 and the inner cavity of the fixed base 20 to facilitate the second end 825 of the locking member 82 to rotate along the first end 823 and prevent the locking member 82 from interfering with the fixed base 20 during unlocking, thereby affecting the unlocking effect. In the prior art, the end of the locking member 82 that contacts the boss 25 of the fixed base 20 is embedded in the inner wall of the fixed base 20 and connected to the inner wall of the fixed base 20. This structure will increase the pulling force when pulling the locking member 82 to unlock. The locking member 82 of the present invention overlaps the surface of the boss 25 of the fixed base 20, thereby reducing the pulling force required for unlocking. A first rounded corner 253 is defined between the proximal end of the inclined surface 251 and the inner surface of the fixed frame 21, and a second rounded corner 255 is defined between the distal end of the inclined surface 251 and the side surface of the boss 25. Specifically, the first end 823 of the locking member 82 overlaps the first rounded corner 253. When the first end 823 of the locking member 82 abuts the inclined surface 251, the pushing member 84 abuts the proximal end surface of the locking member 82, causing the distal end surface of the first end 823 to abut the inclined surface 251. The locking member 82 is tilted relative to the drive shaft 72, and the locking hole 820 of the locking member 82 engages with the positioning portion 720 of the drive shaft 72, thereby fixing the drive shaft 72 relative to the fixed base 20.

[0059] like Figure 7-11As shown, in this embodiment, the locking member 82 is a plate-like structure, and the locking member 82 includes a first end 823 and a second end 825 relative to each other. The first end 823 abuts the inner cavity of the fixed base 20, and the second end 825 can be rotated around the first end 823 until the axis of the locking hole 820 is coaxial with the axial direction of the fixed base 20 to facilitate the axial movement of the drive shaft 72. When the locking piece 82 is tilted relative to the drive shaft 72 so that the edge of the locking hole 820 is engaged with the positioning portion 720 of the drive shaft 72, the axis of the locking hole 820 is tilted to the axial direction of the fixed base 20, and the push piece 84 pushes against the proximal end surface of the locking piece 82, and the locking piece 82 limits the axial movement of the drive shaft 72; when the second end 825 of the locking piece 82 rotates around the first end 823 until the axis of the locking hole 820 is coaxial or parallel to the axial direction of the fixed base 20, the locking piece 82 releases the lock on the drive shaft 72, and at this time, the drive shaft 72 can move axially in the locking hole 820.

[0060] like Figure 7 、 Figure 9 and Figure 12 As shown, the push member 84 includes a first side 841 and a second side 843 relative to each other, the first side 841 abuts against the inner wall of the fixed base 20, and the second side 843 abuts against the proximal surface of the locking member 82. The push member 84 elastically abuts against the locking member 82 to tilt the locking member 82 relative to the drive shaft 72 to ensure that the edge of the locking hole 820 is engaged with the positioning portion 720 of the drive shaft 72. Specifically, the push member 84 is a sheet structure made of elastic material, and the push member 84 also includes a middle portion connected between the first side 841 and the second side 843. The middle portion of the push member 84 bends toward the proximal end and gradually abuts against the inner wall of the fixed base 20 so that the push member 84 has a stable elastic force. In the initial state, the push member 84 is in a state of bending and deformation after being compressed, thereby limiting the movement of the locking member 82 toward the proximal end. Preferably, a first side 841 of the push member 84 is provided with a snap-on tab 845. A slot 27 is defined at the proximal end of the inner wall of the fixed frame 21, communicating with the inner cavity thereof, for securing the push member 84. The slot 27 is closer to the proximal end than the boss 25, facilitating bending of the push member 84 and abutting the locking member 82. The snap-on tab 845 of the push member 84 engages within the slot 27 of the fixed base 20, securing the push member 84 to the fixed base 20 and preventing the push member 84 from deflecting. A through hole 846 is defined axially in the middle portion of the push member 84, through which the drive shaft 72 extends axially. In the prior art, the push member is recessed distally to abut against the proximal end surface of the locking member 82. Opposing sides of the push member are embedded in the fixed base 20. To unlock the lock, pulling the locking member 82 requires squeezing the push member to deform it. In this case, a relatively large unlocking force is required to overcome the elastic force of the push member. In the present invention, since the push member 84 is protruded toward the proximal end of the locking plate and only one side abuts the proximal end surface of the locking member 82, the resistance required to squeeze the push member is small, that is, the pulling force required to unlock is small.

[0061] In this embodiment, the width of the boss 25 is smaller than the width of the base of the push member 84, and the width of the retaining slot 27 of the fixed base 20 is also smaller than the width of the base of the push member 84. The retaining tab 845 of the push member 84 fits snugly within the retaining slot 27 of the fixed base 20, preventing the locking member 82 from shifting under the action of the unlocking force. Similarly, the locking member 82 does not shift during the process of returning to the locked state, thereby ensuring both unlocking and locking effects.

[0062] like Figure 13 As shown, in other embodiments, a notch 847 is defined in the middle of the push member 84a, the drive shaft 72 is inserted axially through the notch 847, and one end of the notch 847 facing away from the engaging piece 845 passes through the second side 843 of the push member 84a.

[0063] In other embodiments, the first side 841 of the pushing member 84 may also be directly clamped, welded, or glued to the inner wall of the fixed base 20 .

[0064] Please also refer to Figure 5-Figure 6 and Figures 14-18 The locking mechanism 80 further includes an unlocking control member 86. In this embodiment, the unlocking control member 86 is unilaterally unlocked, meaning that the unlocking control member 86 is connected to a single side (the second end 825) of the locking member 82. Specifically, the unlocking control member 86 is connected to the second end 825 of the locking member 82. Pulling the unlocking control member 86 proximally causes the second end 825 of the locking member 82 to rotate proximally about the first end 823. The push member 84 elastically deforms, creating a gap between the outer circumference of the drive shaft 72 and the locking hole 820 and the through hole 846 of the push member 84, allowing the drive shaft 72 to move axially. When the pulling force on the unlocking control member 86 is released, the push member 84 returns to its initial state, and the second end 825 of the push locking member 82 rotates distally about the first end 823 until the locking member 82 is locked to the positioning portion 720 of the drive shaft 72, thereby fixing the drive shaft 72 relative to the fixed base 20. In the prior art, the unlocking control member is a bilaterally symmetrical open structure, with only one side abutting the locking member. When the unlocking control member is pulled, the side abutting the locking member moves proximally and pulls the locking member, while the other side remains stationary. This effectively loses some of the pulling force, resulting in a higher unlocking force. In this embodiment, the unlocking control member 86 is disposed on a single side of the drive shaft 72. The shape of the unlocking control member 86 is a regular, symmetrical structure. When subjected to force, both wires are simultaneously stressed, which further ensures the stability of the unlocking force transmission. Using an unlocking control member 86 with a smaller wire diameter can meet the unlocking force requirements.

[0065] like Figure 17 and Figure 18As shown, in this embodiment, the unlocking control member 86 comprises a double-wire structure that is sleeved over the second end 825 of the locking member 82. Specifically, the double-wire structures are arranged side by side and each sleeves over the second end 825 of the locking member 82. Each row of the double-wire structures includes a connecting segment 862 connected to the second end 825 of the locking member 82, and extension segments 864 extending proximally from opposite ends of the connecting segment 862. The connecting segment 862 and the extension segments 864 form a U-shaped structure that sleeves over the second end 825. The proximal end of each extension segment 864 is connected to the proximal end of the adjacent extension segment 864 via an arcuate connecting segment 866. The unlocking control member 86 in this embodiment is made of nickel-titanium wire that is heat-set and crimped with a stainless steel sleeve.

[0066] To facilitate remote control of the unlocking control member 86 from outside the body, the proximal end of the unlocking control member 86 is detachably connected to the control wire 801. The distal end of the control wire 801 extends outside the patient's body through the tubular assembly of the delivery device 500. The control wire 801 is typically made of a polymer material. In this embodiment, the control wire 801 is U-shaped and intersects the double-wire structure of the unlocking control member 86. Specifically, a gap is provided between each adjacent extension segment 864 of the double-wire structure, adjacent to the junction segment 866, and the control wire 801 intersects these two gaps in sequence.

[0067] The tissue clamp 60 is at least partially made of a shape-memory material that undergoes a heat-setting process. During production, the shape-memory material is first laser-cut into the desired shape, then placed in a mold and heat-set at approximately 550°C to achieve its desired form. In its natural state, the clamping arms 64 on either side of the tissue clamp 60 extend radially outward from the connecting frame 62.

[0068] Preferably, the angle between the two clamping arms 64 in the naturally expanded state should be slightly greater than the angle between the two clamping arms 40. That is, the angle between the length direction of the clamping arm 64 and the axis of the fixed base 20 is greater than or equal to the angle between the clamping arm 40 and the fixed base 20 when the clamping arm 40 corresponding to that side is fully expanded relative to the fixed base 20. This allows the free end of each clamping arm 64 to be close to the corresponding clamping arm 40 and exert a certain clamping force, thereby providing a more stable clamping force. Specifically, in this embodiment, the angle between the length direction of the clamping arm 64 and the axial direction of the fixed base 20 ranges from 0 to 150 degrees. That is, in the naturally expanded state, the angle between the two clamping arms 64 can reach a maximum of 300 degrees, preferably 160 to 200 degrees.

[0069] In this embodiment, the tissue clamp 60 is entirely made of a superelastic nickel-titanium alloy, thereby reducing manufacturing complexity, streamlining the process, and lowering production costs. Furthermore, in other embodiments, the connecting frame 62 and the clamping arm 64 can be manufactured separately and then fixedly connected, as long as the connection between the two has elasticity or shape memory properties, allowing them to collapse and rebound relative to the fixed base 20.

[0070] In this embodiment, the two opposite side walls of the connection frame 62 are respectively provided with a slot 622 (such as Figure 19 ), which is used to engage with the block 23 of the fixed base 20. The shape of the card slot 622 can be rectangular, elliptical, prismatic or other shapes. In this embodiment, a rectangle is preferred for higher matching stability. The fixed base 20 is accommodated in the inner cavity of the connecting frame 62, and the drive shaft 72 is inserted into the fixed base 20 and the connecting frame 62 through the proximal opening of the connecting frame 62. After the connecting frame 62 cooperates with the fixed base 20, it can prevent the fixed base 20 from moving left and right, that is, it plays the role of left and right limit; the mutual engagement of the card block 23 and the card slot 622 can prevent the tissue clamp 60 and the fixed base 20 from moving forward and backward, that is, it plays the role of front and back limit.

[0071] like Figure 5-Figure 8 and Figure 19-20 As shown, each clamping arm 64 is provided with at least one row of barbs 642 along its length. In this embodiment, each clamping arm 64 is provided with a row of barbs 642 on two opposing sides, with four barbs 642 on each side. Preferably, the end of each barb 642 is rounded to prevent puncture of the leaflet.

[0072] Each barb 642 defines an angle A with the clamping arm 64. Angle A ranges from 30 to 85 degrees, preferably from 45 to 65 degrees. Excessively large or small angles A increase the difficulty of capturing the leaflet. The angles A between each barb 642 and the clamping arm 64 can be the same or different. In this embodiment, each barb 642 defines an angle of 30 degrees with the clamping arm 64.

[0073] The effective length L of each barb 642 ranges from 0.3 to 2.0 mm, preferably from 0.5 to 1.2 mm. The effective length L of the barbs 642 can be the same or different. In this embodiment, the barbs in each row of barbs 642 have the same extended length L, i.e., the effective length L of each barb 642 is 0.8 mm.

[0074] In other embodiments, the angle between the barbs in at least one row of barbs 642 of each clamping arm 64 and the corresponding clamping arm 64 gradually increases along the extension direction of the clamping arm 64; the effective length of the barbs in at least one row of barbs 642 of each clamping arm 64 gradually increases from the proximal end to the distal end. The reason for this arrangement is that the thickness of the leaflet is uneven, the leaflet edge is thinnest, and the thickness gradually increases to the point where the leaflet is connected to the annulus. Therefore, according to the anatomical structure of the leaflet that gradually thickens from the leaflet edge to the leaflet center, the force depth of each barb 642 at different contact positions with the leaflet tissue is ensured to be roughly the same, thereby ensuring the clamping force of the clamping arm 64 on the leaflet and preventing the leaflet from piercing. The angle and length of the barb 642 are adjusted to adapt to the force level of leaflet tissue of different thicknesses.

[0075] like Figure 19 and Figure 20 As shown, the free end of each clamping arm 64 is provided with a wire hole 644 for connecting the operating wire 501 of the pushing device 500. The free end of the clamping arm 64 can be controlled by the operating wire 501 extending outside the patient's body. In the delivery state, the free end of the clamping arm 64 is tightened by the operating wire 501 and adheres to the surface of the fixed base 20; after the control of the operating wire 501 on the free end is released, the clamping arm 64 is released, and the clamping arm 64 returns to its natural state due to its own elastic memory properties, and presses the valve tissue toward the clamp arm 40. The operating wire 501 can be a metal wire made of nickel-titanium alloy or the like, and since it has nothing to do with the improvement and creation of the present invention, it will not be described here.

[0076] To ensure safety after implantation, the fixed base 20 and the clamp arm 40 are respectively made of a biocompatible metal material such as stainless steel, cobalt alloy, cobalt-chromium alloy, titanium alloy, or nickel-titanium alloy; the drive assembly 70 is made of a biocompatible polymer material or metal material such as polyester, silicone resin, stainless steel, cobalt alloy, cobalt-chromium alloy, or titanium alloy. In this embodiment, the fixed base 20, the clamp arm 40, and the drive assembly 70 are all made of stainless steel. The locking member 82 and the push member 84 are also made of biocompatible materials. The locking member 82 is preferably made of stainless steel or cobalt-chromium alloy with high hardness, and the push member 84 is made of nickel-titanium alloy with elasticity.

[0077] The following uses the mitral valve repair process as an example to illustrate the operation method of the valve clipping device with a locking mechanism of the present invention, which mainly includes the following steps:

[0078] The first step is to detachably connect the valve clamping device 100 to the distal end of the delivery device 500, proximally tighten the operating wire 501 connected to the clamping arm 64 to control the clamping arm 64 to retract relative to the fixed base 20, causing the clamping arm 64 to abut against the surface of the fixed base 20, and proximally tighten the control wire 801 connected to the unlocking control member 86 to release the locking member 82 from locking the drive shaft 72. The drive shaft 72 is then moved proximally, driving the connecting rod 76 to drive the clamp arm 40 to close relative to the fixed base 20, bringing the valve clamping device 100 into a fully retracted state. The tension on the control wire 801 is then released, and the pushing member 84 pushes the second end 825 of the locking member 82 to rotate distally about the first end 823 until the locking member 82 locks to the positioning portion 720 of the drive shaft 72, maintaining the retracted state of the clamp arm 40.

[0079] Step 2: Femoral vein puncture, using the trans-septal approach, the distal end of the delivery device 500 and the valve clamping device 100 are pushed from the left atrium through the adjustable curved sheath, through the mitral valve to the left ventricle.

[0080] Step 3: Adjust the relative position of the valve clipping device 100 and the mitral valve so that the valve clipping device 100 is close to the anterior leaflet and the posterior leaflet of the mitral valve.

[0081] Step 4: Pull the control wire 801 toward the proximal end to release the lock of the locking member 82 on the drive shaft 72, and then move the drive shaft 72 toward the distal end, thereby driving the connecting rod 76 to drive the clamp arm 40 to open relative to the fixed base 20, releasing the pulling force on the control wire 801, and the pushing member 84 pushes the second end 825 of the locking member 82 to rotate toward the distal end around the first end 823 until the locking member 82 is locked to the positioning portion 720 of the drive shaft 72.

[0082] Step 5: Retract the entire valve clamping device 100 toward the proximal end, so that the forceps arm 40 supports the valve leaflet on the left ventricle side.

[0083] Step 6: Release the control of each operating wire 501 on the corresponding clamping arm 64 to release the clamping arms 64 on both sides. The clamping arms 64 on each side press the valve leaflet 300 on the atrial side and cooperate with the clamp arm 40 on that side to clamp the valve leaflet (such as Figure 21 shown).

[0084] Step 7: Pull the control wire 801 connected to the unlocking control member 86 toward the proximal end to make the second end 825 of the locking member 82 rotate toward the proximal end around the first end 823 until the locking member 82 releases the lock on the drive shaft 72; move the drive shaft 72 toward the proximal end, and the drive shaft 72 drives the connecting rod to drive the clamp arm 40 to close relative to the fixed base 20 until the valve clamping device 100 is completely retracted; release the tension on the control wire 801 until the locking member 82 is locked to the positioning portion 720 of the drive shaft 72, so that the drive shaft 72 and the fixed base 20 are relatively fixed (as shown in FIG. Figure 22 shown).

[0085] Step 9: Release the connection between the valve clamping device 100 and the delivery device, the control wire 801 and the operating wire 501, and withdraw the delivery device, the control wire 801 and the operating wire 501 from the patient's body. At this time, the valve clamping device 100 pulls the anterior and posterior leaflets of the mitral valve toward each other to obtain a double-pore mitral valve, completing the edge-to-edge repair of the mitral valve, and the valve clamping device 100 remains in the patient's body.

[0086] Please also refer to Figure 23-Figure 27 The structure of the valve clamping device 100a provided in the second embodiment of the present invention is similar to the valve clamping device 100 provided in the first embodiment, except that: the side wall of the first end 823a of the locking member 82a in the second embodiment is an arc surface 826, which can improve the force between the contact point between the locking member 82 and the fixed base 20, and prevent metal debris from falling off and fatigue wear of the contact point due to right-angle force; in addition, each clamping arm 64 is connected to the connecting frame 62 by a bending section 641, and the width of the bending section 641 is smaller than the width of the connecting frame 62 and smaller than the width of the clamping arm 64.

[0087] Specifically, if Figure 27 As shown, when the first end 823a of the locking member 82 abuts against the boss 25, the arc surface 826 contacts the inclined surface 251 and the inner wall of the fixed base 20 at the same time, thereby facilitating the second end 825 of the locking member 82 to rotate around the first end 823a. The arc surface 826 of the locking member 82 in this embodiment contacts the boss 25, which can reduce the friction force when the locking member 82 and the fixed base 20 rotate relative to each other, that is, reduce the unlocking force of the unlocking control member 86, and reduce the elastic force of the push member 84 to restore the locked state, thereby improving the locking and unlocking performance; further, since the arc surface 826 contacts the inclined surface 251 of the boss 25 and the inner wall of the fixed base 20 at the same time, there are two contact lines between the arc surface 826 of the locking member 82 and the inner wall of the fixed base 20, that is, the arc surface 826 contacts the inclined surface 251 and the flat surface of the inner wall of the fixed base 20 at the same time, and the contact line on the flat surface can ensure that the locking member 82 will not shift during the unlocking process, thereby ensuring the unlocking stability.

[0088] like Figure 23 As shown, the width of the bending section 641 in this embodiment is smaller than the width of the connecting frame 62 and smaller than the width of the clamping arm 64. This not only reduces the weight of the valve clamping device 100a, facilitates the rebound of the clamping arm 64, reduces the difficulty of clamping, and improves the fatigue resistance of the valve clamping device during long-term implantation in the human body, but also reduces the pulling force required to pull the clamping arm 64 up to fit the central axis through the operating wire 501, reduces the reverse force borne by the operating wire 501, prevents the operating wire 501 from breaking, and improves the safety and effectiveness of the device.

[0089] Preferably, the bending section 641 is a variable diameter structure. Specifically, the bending section 641 includes a first end connected to the connecting frame 62 and a second end connected to the clamping arm 64. The width of the first end is greater than the width of the second end, and the width of the bending section gradually decreases from the first end toward the second end.

[0090] See also Figure 28 The structure of the valve clamping device 100b provided in the third embodiment of the present invention is similar to that of the valve clamping device 100 provided in the first embodiment, except that: the valve clamping device 100b in the third embodiment further includes an adjusting member 90, which is arranged around the outside of the fixed base 20; when the valve clamping device 100b clamps the valve, the adjusting member 90 is elastically clamped between a pair of clamping arms 64, and the adjusting member 90 is used to adjust the degree of traction on the valve tissue on both sides when the pair of clamp arms 40 are closed.

[0091] In this embodiment, the adjusting member 90 is made of an elastic material, the distal end of the adjusting member 90 is fixedly connected to the fixed base 20, and the proximal end of the adjusting member 90 is suspended. Specifically, the adjusting member 90 includes a first end 91 and a second end 93 arranged opposite to the first end 91, the first end 91 is located at the proximal end of the adjusting member 90, and the second end 93 is located at the distal end of the adjusting member 90. Among them, the first end 91 is an open end, and the second end 93 is a closed end formed by folding the heads together. The head of the second end 93 is fixed to the fixed base 20 by common detachable or non-detachable connection methods such as welding, bonding, threaded connection, crimping, and bolt locking. In this embodiment, welding connection is adopted.

[0092] The regulating member 90 includes an elastic body. When the valve clamping device 100b is closed, the elastic body is filled between the anterior and posterior leaflets of the clamped mitral valve and presses against the clamp arms 40. Therefore, it has the following advantages: (1) the elastic body has a buffering effect on the pulsating leaflets, so that the degree of traction of the leaflets by the valve clamping device 100b can be adjusted to avoid damaging the leaflets; (2) the elastic body can be squeezed and deformed following the pulsation of the leaflets, and the elastic force generated pushes the part of the leaflet close to the elastic body away from the fixed base 20, so that the clamping angle between the anterior and posterior leaflets of the mitral valve is smaller than the opening angle between the clamp arms 40, which can reduce the traction of the leaflets by the valve clamping device 100b. The degree of traction of the valve leaflet by the valve clamping device 100b is always kept within a reasonable range; (3) the elastic body can buffer the direct flushing of the blood flow on the inside of the valve clamping device 100b, prevent the valve clamping device 100b from being continuously flushed by blood and falling off, and also prevent blood from accumulating in the dead corners between the clamping parts of the valve clamping device 100b to form thrombi; (4) when the elastic body is subjected to the pressure of the valve, it will produce a certain degree of deformation, and the degree of deformation increases with the increase of pressure, thereby preventing the elastic body from being squeezed by the clamp arm 40 after grasping the valve leaflet and acting on the clamp arm 40 in turn, ensuring that the grasping effect of the valve leaflet by the valve clamping device 100b after release is consistent with that before release.

[0093] See also Figure 29 The structure of the valve clamping device 100c provided in the fourth embodiment of the present invention is similar to that of the valve clamping device 100b provided in the third embodiment, except that a biocompatible mesh film 92 is provided on the outside and / or inside of the adjusting member 90, the clamping arm 64, and / or the clamp arm 40. The mesh film 92 is a woven mesh structure with a plurality of mesh holes. The adjusting member 90 with the mesh film 92 not only increases biocompatibility, avoids tissue allergies and inflammatory reactions, and improves product safety, but also forms an artificial barrier on the atrial side of the valve leaflet to block blood clots, close the opening of the entire valve clamping device 100c facing the atrial side, and prevent blood from repeatedly flushing in the internal blind spots of the valve clamping device 100c to form clots, thereby preventing thrombosis.

[0094] The mesh film 92 can be made of polymer materials such as polyethylene terephthalate, polypropylene, polytetrafluoroethylene, polyurethane, etc. The mesh film materials covering the outside and / or inside of the adjusting part 90, the clamping arm 64 and the clamp arm 40 can be the same or different. In this embodiment, all three are made of PET and are covered on the outside of the adjusting part 90, the clamping arm 64 and the clamp arm 40.

[0095] The following tensile test is used to illustrate the difference in unlocking force and locking force between the present invention and the prior art. Figure 30 As shown:

[0096] Three groups of valve clamping devices were made respectively. The first group (A1-A4) is the valve clamping device 100 of the first embodiment of the present invention. The drive shaft 72 is provided with a positioning portion 720, and one side of the locking member 82 overlaps the inner wall of the fixed base 20, and a single-sided unlocking control member is used. The drive shaft of the valve clamping device of the second group of embodiments (B1-B4) is also provided with a positioning portion, and one side of the locking member overlaps the inner wall of the fixed base, but the unlocking control member adopts a double-sided structure. The third group of comparative examples (C1-C4) is a valve clamping device of the prior art. The outer peripheral surface of the drive shaft has no positioning portion, and one side of the locking member is embedded in the inner wall of the fixed base for a fixed connection. The following performance tests were performed on the three groups of valve clamping devices respectively:

[0097] 1. Unlocking force test (unlocking force test of control parts)

[0098] The smooth opening and closing performance of the valve clipping devices of Examples A1 to A4, Examples B1 to B4, and Comparative Examples C1 to C4 were tested respectively.

[0099] Testing equipment: HY-0580 electronic universal tensile testing machine produced by Shanghai Hengyi Precision Instrument Co., Ltd.

[0100] Test method: Connect the valve clamping device to the delivery device 500, connect the control wire 801 to the unlocking control part 86 and pass through the proximal end of the delivery device 500, and the push shaft on the delivery device 500 is connected to the drive shaft 72 of the valve clamping device and can be operated at the proximal end of the simple handle. Fix the simple handle on the machine table of the tensile testing machine, and the moving end of the tensile testing machine hooks the proximal end of the control wire 801. The tensile testing machine applies an unlocking force to the control wire 801, operates the push shaft at the proximal end of the simple handle, and records the unlocking force value required for the push shaft to smoothly open and close the valve clamping device.

[0101] 2. Locking force test (self-locking force test of drive shaft and locking member)

[0102] The locking forces (ie, the locking forces between the drive shaft and the locking member) of the valve clipping devices of Examples A1 to A4, Examples B1 to B4, and Comparative Examples C1 to C4 were tested respectively.

[0103] Test method: Connect the valve clamping device to the simple handle, pass the test line through the connecting seat 74 of the drive shaft 72, fix the simple handle on the platform of the tensile testing machine, hook the moving end of the tensile testing machine to the end of the test line, move the moving end at a constant speed of 4.5mm / min, and record the force value when the drive shaft 72 and the locking part 82 slip and fail.

[0104] pass Figure 30It can be seen from the test result table that the unlocking force required for the one-side unlocking control member in the first group of embodiments A1 to A4 is smaller, and the locking force is stronger.

[0105] It should be noted that the above description uses the example of a valve clipper used to alleviate or treat mitral regurgitation. It is understood that in other embodiments, the valve clipper can also be used to alleviate or treat tricuspid regurgitation. The principles and structure of the valve clipper are substantially similar to those of the valve clipper used to treat mitral regurgitation in the embodiments of the present invention. Multiple sets of proximal and distal clips are used to form multiple clamps, each clamping a valve leaflet. This is not further described here.

[0106] Obviously, in other embodiments, the valve clipper provided by the present invention can also be used in other minimally invasive surgical operations that require clamping three or more leaf-shaped valves together.

[0107] Obviously, in other embodiments, the valve clipper provided by the present invention can also be used in other minimally invasive surgical operations that require clamping three or more leaf-shaped valves together.

[0108] The above is an implementation of the embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the embodiment of the present invention. These improvements and modifications are also considered to be within the scope of protection of the present invention.

Claims

1. A valve clamping device with a locking mechanism, characterized in that: include: Fixed base; At least one pair of clamp arms, the at least one pair of clamp arms being connected to the fixed base and being openable and closable relative to the fixed base; a drive assembly, the drive assembly comprising a drive shaft movably inserted into the fixed base, the drive shaft moving axially to drive the clamp arm to open and close relative to the fixed base, a positioning portion being provided on an outer peripheral surface of the drive shaft; and A locking mechanism, comprising a locking member, a push member, and an unlocking control member, wherein the locking member has a locking hole axially defined therein, the drive shaft being inserted into the locking hole, the push member abutting against the locking member so that the locking member is tilted in the fixed base so that the edge of the locking hole is engaged with the positioning portion, and the unlocking control member is connected to one side of the locking member for controlling the unlocking of the locking member; The locking member comprises a first end and a second end opposite to each other, the first end abutting against the inner cavity of the fixed base, and the second end being rotatable around the first end until the axis of the locking hole is coaxial with the axial direction of the fixed base; The push member includes a first side and a second side opposite to each other, and a middle portion connected between the first side and the second side, the middle portion bends toward the proximal end and gradually abuts against the inner wall of the fixed base, the first side abuts against the inner wall of the fixed base, and the second side abuts against the proximal end surface of the locking member.

2. The valve clipping device with a locking mechanism according to claim 1, wherein: The positioning portion includes a plurality of grooves and / or protrusions arranged facing the locking hole, and the edge of the locking hole is engaged with any of the grooves and / or protrusions.

3. The valve clipping device with a locking mechanism according to claim 2, wherein: The plurality of grooves or protrusions are arranged in parallel, and the width of the grooves or protrusions ranges from 0.04 to 0.30 mm.

4. The valve clipping device with a locking mechanism according to claim 1, wherein: The inner cavity of the fixed base is provided with a boss, the first end of the locking member abuts against the boss, and a gap is formed between the second end of the locking member and the inner cavity of the fixed base.

5. The valve clipping device with a locking mechanism according to claim 4, characterized in that: The proximal end of the boss is provided with an inclined surface, the first end of the locking member overlaps the inclined surface, and the pushing member abuts the proximal end surface of the locking member so that the distal end surface of the first end is in contact with the inclined surface.

6. The valve clipping device with a locking mechanism according to claim 5, characterized in that: The side wall of the first end of the locking member is an arc surface, and the arc surface contacts the inclined surface and the inner wall of the fixed base at the same time.

7. The valve clipping device with a locking mechanism according to claim 1, wherein: The push member is made of elastic material, and one end of the push member is provided with a clamping piece, the inner wall of the fixed base is provided with a clamping groove, and the clamping piece is clamped in the clamping groove.

8. The valve clipping device with a locking mechanism according to claim 1, wherein: A through hole is axially provided in the middle of the push member, and the drive shaft is axially inserted into the through hole.

9. The valve clipping device with a locking mechanism according to claim 1, wherein: The unlocking control member is connected to the second end of the locking member, and pulling the unlocking control member toward the proximal end causes the second end of the locking member to rotate around the first end.

10. The valve clipping device with a locking mechanism according to claim 9, wherein: The unlocking control member includes a double-line structure, which is arranged side by side and is both sleeved on the second end of the locking member.

11. A valve repair system, characterized in that: It comprises the valve clamping device according to any one of claims 1 to 10, and also comprises a delivery device detachably connected to the valve clamping device, the delivery device comprising an operating wire, and the distal end of the operating wire is detachably connected to the unlocking control member.

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