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 comprises a fixed base, at least one pair of clamp arms, a driving assembly and a locking mechanism, wherein 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 driving assembly comprises a driving shaft movably inserted in the fixed base, the driving shaft moves axially to drive the clamp arms to open and close relative to the fixed base, and a positioning portion is provided on the outer peripheral surface of the driving shaft; the locking mechanism comprises a locking member and a push member, the locking member has a locking hole axially provided, the driving shaft is inserted into the locking hole, 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 clamped to the positioning portion. The locking mechanism of the present invention can increase the friction and mechanical bite force between the driving 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 normal and healthy mitral valve 1 can control the blood flow from the left atrium 2 to the left ventricle 3, while preventing the blood from the left ventricle 3 to the left atrium 2. The mitral valve 1 includes 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 muscle 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 are completely aligned to prevent blood from flowing from the left ventricle 3 to the left atrium 2. Please refer to Figure 2 When organic or functional changes occur in the leaflets of the mitral valve 1 or its related structures, such as partial rupture of the chordae tendineae 4, the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1 are not properly aligned. As a result, when the heart contracts, the mitral valve 1 cannot be completely closed, causing blood to reflux from the left ventricle 3 to the left atrium 2, thereby causing a series of pathophysiological changes, known as "mitral regurgitation".

[0003] Surgery usually uses surgical methods such as valve edge-to-edge suture to treat mitral regurgitation. However, this type of surgical procedure has the disadvantages of complex surgical procedures, high surgical costs, high degree of patient trauma, high risk of complications, long hospital stay, and painful recovery process for patients. There is currently a minimally invasive treatment device, which is based on the principle of valve edge-to-edge surgery. The valve clip is delivered to the mitral valve through an interventional catheter, and then the anterior and posterior leaflets of the mitral valve are grasped at the same time through the relative opening of the clip, so that the leaflets are pulled toward each other, thereby reducing the leaflet gap and treating mitral regurgitation.

[0004] There is a valve clip with a locking mechanism, which includes a wedge-shaped element and a metal frame overlapped with the wedge-shaped element. A through hole is provided in the middle of the wedge-shaped element, and a driving shaft of the valve clamp is passed through the through hole. When the metal frame is pulled toward the proximal end, one end of the wedge-shaped element is pulled and the other end is stationary, thereby reducing the friction between the driving shaft and the through hole, so that the driving shaft can move in the through hole. However, since the surface of the driving shaft is a smooth structure and the inner surface of the through hole of the wedge-shaped element is also a smooth structure, the friction between the two is small, so the locking force is small, and the locking mechanism may wear, slip or fail, resulting in the valve clamp opening prematurely during transportation, or accidentally opening during the process of clamping the valve leaf, or the valve clip falling off 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 driving 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 driving assembly comprises a driving shaft movably inserted in the fixed base, the driving shaft moves axially to drive the clamp arms to open and close relative to the fixed base, and a positioning portion is provided on the outer peripheral surface of the driving shaft; the locking mechanism comprises a locking piece and a pushing piece, the locking piece has a locking hole axially arranged, the driving shaft is inserted into the locking hole, 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 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 part, 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 part 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 driving 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 in locking. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] In order to more clearly illustrate the technical solution of the embodiment of the present invention, the drawings required for use in the implementation mode will be briefly introduced below. Obviously, the drawings described below are some implementation modes of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying 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 diagram of the three-dimensional structure 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 A 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 Enlarged 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] Fig. 9 yes Figure 8 Magnified view of section IX.

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

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

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

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

[0023] Fig.14 yes Figure 5 A three-dimensional structural schematic diagram of the unlocked state of the locking mechanism of the valve clamping device.

[0024] Fig.15 yes Fig.14 Side view of the unlocked state of the locking mechanism of the valve clamping device in FIG.

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

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

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

[0028] Fig.19 yes Figure 5 A schematic diagram of the three-dimensional structure of the fixed base, part of the driving components, the locking mechanism and the clamping arm.

[0029] Fig. 20 yes Fig.19 Side view of.

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

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

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

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

[0034] Fig.25 yes Fig.23 A schematic structural diagram of a fixed base, a part of a driving assembly and a locking mechanism of a valve clamping device with a locking mechanism.

[0035] Fig.26 yes Fig.25 A partial cross-sectional view of the valve clamping device in FIG.

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

[0037] Fig.28 1 is a schematic structural diagram of a valve clamping device with a locking mechanism provided in a third embodiment of the present invention.

[0038] Fig.29 4 is a schematic structural diagram of a valve clamping device with a locking mechanism provided in a fourth embodiment of the present invention.

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

[0040] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. 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 are with reference to the attached drawings to illustrate specific embodiments in which the present invention may be implemented. The directional terms mentioned in the present invention, such as "upper", "lower", "front", "back", "left", "right", "inner", "outer", "side", etc., are only with reference to the directions of the attached drawings. Therefore, the directional terms used are for better and clearer description and understanding of the present invention, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention.

[0042] In the description of the present invention, it should be noted that in the field of interventional medical devices, the proximal end refers to the end closer to the operator, while the distal end refers to the end farther from the operator; the axial direction refers to the direction parallel to the line connecting the distal center and the proximal center of the medical device in the natural state. The above definitions are only for the convenience of expression and cannot be understood as limitations of the present invention.

[0043] Please also read Figure 3 - Fig. 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. 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, each clamping arm 64 moves closer to the forceps arm 40 after being released and cooperates with the forceps arm 40 on the corresponding side to clamp the valve tissue between the two.

[0044] Specifically, the driving assembly 70 includes a driving shaft 72 movably inserted in the fixed base 20. The driving shaft 72 moves in the axial direction to drive the clamp arm 40 to open and close relative to the fixed base 20. The outer peripheral surface of the driving 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 is provided with a locking hole 820 in the axial direction. The driving shaft 72 is inserted into the locking hole 820. The push member 84 pushes against the locking member 82 and is obliquely arranged in the fixed base 20, so that the edge 281 of the locking hole 820 is clamped with the positioning portion 720, so that the driving shaft 72 is relatively fixed 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 inserted into 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 released through the operating wire 501 (such as Fig.19 and Fig. 20As shown in the figure, the two clamping arms 64 of the valve clamping device 100 are pulled up to fit the central axis, at which time the push piece 84 pushes against the locking piece 82 which is obliquely arranged on the fixed base 20, so that the edge 281 of the locking hole 820 is clamped on the positioning portion 720, limiting the relative movement between the drive shaft 72 and the fixed base 20, and then locking the relative movement between the clamp arm 40 and the fixed base 20; then the locking piece 82 is pulled over a long distance by the control wire 801, so that the edge 281 of the locking hole 820 and the drive shaft 72 can move relative to each other, at which time the locking piece 82 applies pressure to the push piece 84 so that the push piece 84 is bent and deformed, and then the drive shaft 72 is operated to make the clamp arm 40 retract to the outer surface of the fixed base 20, and then the locking piece 82 is released, the push piece 84 returns to its initial state and pushes against the locking piece 82 to return to the oblique setting on the fixed base 20, the edge 281 of the locking hole 820 is clamped on the positioning portion 720, and the clamp arm 40 and the fixed base 20 are locked. The valve clamping device 100 is then pushed to the mitral valve of the patient, and after being adjusted to a suitable 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 toward the clamp arm 40, thereby pressing the valve leaflet toward the clamp arm 40. When the anterior leaflet and the posterior leaflet of the mitral valve are clamped together by the clamp arm 40 and the corresponding clamp arm 64, respectively, the locking member 82 is unlocked from the drive shaft 72, 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 tube body assembly and the valve clamping device 100 is released, and the delivery device 500 is withdrawn. The valve clamping device 100 is left in the patient's body as an implant, so as to keep the valve leaflet in the corresponding position together, realize the "edge-to-edge repair" of the mitral valve, and reduce 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 sheath tubes and shaping sheath tubes.

[0047] In the present invention, a positioning portion 720 is provided on the outer peripheral surface of the drive shaft 72 of the valve clamping device 100, and the drive shaft 72 is inserted into the locking hole 820 of the locking piece 82. The push piece 84 pushes against the locking piece 82 and is obliquely arranged in the fixed base 20, so that the edge 281 of the locking hole 820 is engaged with the positioning portion 720 to increase the friction and mechanical bite force between the drive shaft 72 and the locking piece 82, which can not only prevent the edge of the locking hole 820 of the locking piece 82 from being locally subjected to force and wear, but also the edge of the drive shaft 72 and the locking hole 820 have a certain bite amount, and the two will be more tightly engaged under the action of force, and the edge of the drive shaft 72 and the locking hole 820 are not simply matched by friction, thereby improving the locking force and stability of the locking mechanism 80 and preventing the valve clamping device 100 from failing in locking.

[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 be increased; therefore, the outer peripheral surface of the drive shaft 72 and the inner surface of the locking hole 820 can be prevented 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 clamping device 100 includes a pair of clamp arms 40 arranged opposite to each other, and each clamp arm 40 can be opened and closed relative to the fixed base 20. Each clamp arm 40 includes a connecting frame 42 and a clamping frame 44 connected to one end of the connecting frame 42 away from the fixed base 20. The ends of the connecting frames 42 of the two clamp arms 40 away from the clamping frames 44 are stacked on each other and hinged to the fixed base 20. A leaflet accommodating space is formed between the clamping arm 64 and the clamp arm 40; specifically, the surface of each clamp arm 40 facing the clamp arm 64 is inwardly recessed to form a receiving groove 45, so that when the valve clamping device 100 is in the transport state, the clamping arm 64 is at least partially accommodated in the receiving groove 45 of the clamp arm 40, so as to reduce the outer diameter and volume of the valve clamping device 100, which is convenient for in vivo transport. After the clamp arm 40 and the clamp arm 64 cooperate to clamp the leaflet, the leaflet is clamped in the receiving groove 45 to increase the contact area between the clamp arm 40 and the leaflet, and the leaflet is pressed into the receiving groove 45 of the clamp arm 40 by the clamp arm 64, which can also increase the clamping force on the leaflet 300. One end of the connecting frame 42 adjacent to the fixed base 20 extends obliquely toward the proximal end and is hinged on the fixed base 20, that is, the connecting frame 42 is provided with a pin hole for inserting a pin, and the pin is connected to the fixed base 20.

[0050] The clamp arms 40 are driven by the driving assembly 70 to open and close relative to the fixed base 20, and the angle between the two clamp arms 40 can reach a maximum of 300 degrees, that is, after the clamp arms 40 are opened relative to the fixed base 20, they can be turned downward to a certain extent, which is conducive to clamping the valve in motion and improving the clamping success rate. If the clamping effect is not ideal, the valve leaflet can be loosened by turning the clamp arms 40 downward and re-clamping. In this embodiment, the angle between the two clamp 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 force when the clamp arm 40 contacts 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 a 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 also 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 driving assembly 70 further includes a connecting seat 74 disposed at the distal end of the driving shaft 72 and a pair of connecting rods 76 movably connected to both sides of the connecting seat 74. The driving shaft 72 movably passes through the fixed base 20 and is connected to the connecting seat 74. One end of each connecting rod 76 is connected to a corresponding clamp arm 40, and the other end is connected to the connecting seat 74 by pivoting, that is, each clamp arm 40 is rotatably connected to the connecting seat 74 of the driving assembly 70 through the connecting rod 76 on the corresponding side.

[0054] In this embodiment, one end of the connecting frame 42 of each clamp arm 40 away from the clamping frame 44 is rotatably connected to the same position of the fixed base 20, and the part of the connecting frame 42 of each clamp arm 40 close to the clamping frame 44 is rotatably connected to the proximal end of the connecting rod 76 on the corresponding side, and the distal end of the connecting rod 76 is rotatably connected to the connecting seat 74 at the distal end of the driving shaft 72 by means of a pin or a bolt. When the driving shaft 72 slides toward the distal end relative to the fixed base 20 in the axial direction, the connecting rod 76 is driven to move, and under the pull of the connecting rod 76, the clamp arm 40 rotates around the pin hole and opens relative to the fixed base 20. When the driving shaft 72 slides toward the proximal end relative to the fixed base 20 in the axial direction, the connecting rod 76 pulls the clamp arm 40 to rotate around the pin hole and close relative to the fixed base 20.

[0055] The connection seat 74 includes two opposite first planes and two connection surfaces connecting the two first planes, and a pair of pin holes penetrating the two first planes are respectively provided at opposite ends of the connection seat 74. The pin holes are used to connect the clamp arm 40 through a pin hinge. The cross-sectional dimension of the connection seat 74 parallel to the second plane direction gradually decreases from the proximal end to the distal end, that is, the shape of the connection seat 74 is any structure such as a hemisphere, a spherical crown or a bullet shape, so that the valve clamping device 100 is easier to push in the body. The connection seat 74 and the drive shaft 72 can be an integral structure or a non-integrated structure. In this embodiment, the connection seat 74 and the drive shaft 72 are non-integrated structures, the drive shaft 72 is a round rod body, and the distal end of the round rod body is provided with an external thread. The drive shaft 72 is screwed to the connection seat 74 and then welded and fixed. In other embodiments, the drive shaft 72 can be fixedly connected to the connection seat 74 by other detachable or non-detachable connection methods such as snap-fitting.

[0056] The outer circumference of the drive shaft 72 is provided with a positioning portion 720, which 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 avoid the edge of the locking hole 820 of the locking plate 82 from being worn by force, 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 range of the groove 722 should be set to 0.04-0.30 mm, preferably 0.08-0.20 mm. If the width of the groove 722 is too small, the embedding overlap amount of 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 closing degree of the valve clamping device is affected. Specifically, each groove 722 is provided with a circle 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 facing the locking hole 820 of the locking member 82, and the edge of the locking hole 820 is engaged with the corresponding protrusion. Specifically, each protrusion is a flange provided along the circumference of the drive shaft 72, and the plurality of flanges are arranged axially at the distal end of the drive shaft 72. Preferably, the plurality of flanges are arranged in parallel, that is, evenly spaced along the axial direction of the drive shaft 72. The width of the protrusion 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, a clamping block 23 disposed at opposite sides of the fixed frame 21, and a boss 25 disposed in the inner cavity of the fixed base 20. The fixed base 20 is provided with a through hole 24 that penetrates the connecting block 22 and the fixed frame 21 in the axial direction, and 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, and the axis center line of the pin hole 26 is perpendicular to the axis center line of the through hole 24, and the pin hole 26 is used to be connected to the connecting portion 42 of the clamp arm 40 through a pin. The boss 25 is provided on one side wall of the inner cavity of the fixed frame 21, and the proximal end of the boss 25 is provided with an inclined surface 251. The first end 823 of the locking member 82 abuts against the boss 25, and there is a gap 826 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 to prevent the locking member 82 from interfering with the fixed base 20 when 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 chamfer 253 is provided between the proximal end of the inclined surface 251 and the inner surface of the fixed frame 21, and a second chamfer 255 is provided 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 chamfer 253, and when the first end 823 of the locking member 82 is attached to the inclined surface 251, the push member 84 pushes against the proximal end surface of the locking member 82 so that the distal end surface of the first end 823 is attached to the inclined surface 251, the locking member 82 is inclined to the driving shaft 72, and the locking hole 820 of the locking member 82 is engaged with the positioning portion 720 of the driving shaft 72, so that the driving shaft 72 is relatively fixed to the fixing base 20.

[0059] like Figure 7 - Fig.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 against the inner cavity of the fixed base 20, and the second end 825 can rotate around the first end 823 until the axis line of the locking hole 820 is coaxial with the axis 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 relative 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 , Fig. 9 and Fig.12 As shown, the push member 84 includes a first side 841 and a second side 843 opposite 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 make the locking member 82 tilt relative to the drive shaft 72 to ensure that the edge of the locking hole 820 is clamped to 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 is bent 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, correspondingly, a first side 841 of the push member 84 is provided with a card-joint piece 845, and a card-joint groove 27 communicating with the inner cavity of the fixed frame 21 is provided at the proximal end of the inner wall thereof for fixing the push member 84, and the card-joint groove 27 is closer to the proximal end than the boss 25 so as to facilitate the push member 84 to bend and abut against the locking member 82. The card-joint piece 845 of the push member 84 is card-joined in the card-joint groove 27 of the fixed base 20, so that the push member 84 is fixedly connected to the fixed base 20, and the push member 84 is prevented from deflecting. A through hole 846 is provided in the middle of the push member 84 along the axial direction, and the drive shaft 72 is inserted into the through hole 846 along the axial direction. In the prior art, the push member is recessed toward the distal end and abuts against the proximal end surface of the locking member 82, and the opposite sides of the push member are embedded in the fixed base 20. When unlocking, pulling the locking member 82 requires squeezing the push member to deform it. At this time, the required unlocking force is relatively large to overcome the elastic force of the push member. In the present invention, since the push member 84 is protruded toward the proximal end at the proximal end of the locking plate and only one side abuts against the proximal end surface of the locking member 82, the resistance to be overcome by squeezing the push member is small, that is, the pulling force required for unlocking 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 slot 27 of the fixed base 20 is also smaller than the width of the base of the push member 84. The engaging piece 845 of the push member 84 is just embedded in the slot 27 of the fixed base 20, so that the locking member 82 will not be offset under the action of the unlocking force. Similarly, the locking member 82 will not be displaced during the process of returning to the locked state, thereby ensuring both the unlocking effect and the locking effect.

[0062] like Fig.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 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 read Figure 5 - Figure 6 and Fig.14 - Fig.18 The locking mechanism 80 further includes an unlocking control member 86. The unlocking control member 86 in this embodiment is a single-side unlocking, and the single-side unlocking means that the unlocking control member 86 is connected to a single side (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. When the unlocking control member 86 is pulled toward the proximal end, the second end 825 of the locking member 82 rotates toward the proximal end around the first end 823, and the push member 84 is elastically deformed, so that there is 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, and the drive shaft 72 can move axially. When the pulling force on the unlocking control member 86 is released, the push member 84 returns to the initial state and the second end 825 of the push locking member 82 rotates 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, so that the drive shaft 72 is relatively fixed to the fixed base 20. In the prior art, the unlocking control member is a bilaterally symmetrical open structure, in which only one side abuts against the locking member. When the unlocking control member is pulled, the side abutting against the locking member moves toward the proximal end and pulls the locking member, while the other side is fixed, which is equivalent to losing a part of the pulling force, so the required unlocking force is relatively large. In this embodiment, the unlocking control member 86 is arranged on one side of the driving shaft 72, and the shape of the unlocking control member 86 is a regular symmetrical structure. When subjected to force, the two wires are subjected to force at the same time, which can better ensure the transmission stability of the unlocking force. The unlocking control member 86 with a smaller wire diameter can meet the unlocking force requirement.

[0065] like Fig.17 and Fig.18As shown, in this embodiment, the unlocking control member 86 includes a double-wire structure sleeved on the second end 825 of the locking member 82. Specifically, the double-wire structures are arranged side by side and are sleeved on the second end 825 of the locking member 82. Each row of double-wire structures includes a connecting section 862 connected to the second end 825 of the locking member 82, and an extension section 864 extending from the opposite ends of the connecting section 862 to the proximal end respectively, and the connecting section 862 and the extension section 864 form a U-shaped structure sleeved on the second end 825; the proximal end of each extension section 864 is connected to the proximal end of the adjacent extension section 864 through an arc-shaped connecting section 866. The unlocking control member 86 in this embodiment is made of nickel-titanium wire through heat setting and stainless steel sleeve crimping.

[0066] In order to facilitate the remote control of the unlocking control member 86 in vitro, the proximal end of the unlocking control member 86 is detachably connected to the control wire 801. The end of the control wire 801 extends outside the patient's body through the tube assembly of the delivery device 500. The control wire 801 is usually made of a polymer material. In this embodiment, the control wire 801 is U-shaped and penetrates the double-wire structure of the unlocking control member 86, that is, a gap is set between each two adjacent extension sections 864 of the double-wire structure at the adjacent joint section 866, and the control wire 801 sequentially penetrates the two gaps.

[0067] The tissue clamp 60 is at least partially made of a material having a shape memory function and is heat-set. When manufacturing, the shape memory material is first cut into a desired shape by laser cutting, and then placed in a mold and heat-set at about 550°C to give it a specific shape. In a natural state, the clamping arms 64 on both sides of the tissue clamp 60 both extend radially outward relative to the connecting frame 62.

[0068] Preferably, the angle between the two clamping arms 64 in the naturally unfolded state should be slightly larger 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 direction of the fixed base 20 is larger than or equal to the angle between the clamping arm 40 and the fixed base 20 when the clamping arm 40 corresponding to the side is fully opened relative to the fixed base 20, so that the free end of each clamping arm 64 and the corresponding clamping arm 40 are close to each other and have a certain clamping force to provide 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 is in the range of 0-150 degrees, that is, in the natural state, the angle between the two clamping arms 64 can reach up to 300 degrees, preferably 160-200 degrees.

[0069] In this embodiment, the tissue clamp 60 is made of superelastic nickel-titanium alloy, thereby reducing the difficulty of the production process, simplifying the process flow, and reducing the production cost. In addition, in other embodiments, the connection frame 62 and the clamping arm 64 can be made separately and then fixedly connected, as long as the connection between the two has elasticity or shape memory properties and can be retracted and rebounded relative to the fixed base 20.

[0070] In this embodiment, two opposite side walls of the connection frame 62 are respectively provided with slots 622 (such as Fig.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 and the fixed base 20 are matched, it can prevent the fixed base 20 from moving left and right, that is, it plays a role of left and right limit; the block 23 and the card slot 622 are mutually engaged to prevent the tissue clamp 60 and the fixed base 20 from moving forward and backward, that is, it plays a role of front and back limit.

[0071] like Figure 5 - Figure 8 and Fig.19 - Fig. 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 opposite sides, and the number of barbs 642 in each row is four. Preferably, the end of each barb 642 is rounded to avoid piercing the leaflet.

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

[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 extension length L of the barbs in each row of barbs 642 is the same, that is, 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 the thinnest, and the thickness gradually increases to the connection between the leaflet and the valve ring. Therefore, according to the anatomical structure of the leaflet that gradually thickens from the leaflet edge to the leaflet, the force depth of each barb 642 at different contact positions with the leaflet tissue is ensured to be roughly the same, so as to ensure the clamping force of the clamping arm 64 on the leaflet, and will not pierce the leaflet, so as to adjust the angle and length of the barb 642 to adapt to the force degree of leaflet tissue with different thicknesses.

[0075] like Fig.19 and Fig. 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, and the free end of the clamping arm 64 can be controlled by the operating wire 501 extending outside the patient's body. In the conveying 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 a natural state due to its own elastic memory performance, 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, which is irrelevant to the improvement and creation of the present invention and will not be described here.

[0076] To ensure safety after implantation, the fixed base 20 and the clamp arm 40 are respectively made of biocompatible metal materials such as stainless steel, cobalt alloy, cobalt-chromium alloy, titanium alloy or nickel-titanium alloy; the drive assembly 70 is made of biocompatible polymer materials or metal materials 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 higher hardness, and the push member 84 is made of nickel-titanium alloy with elasticity.

[0077] The following takes the mitral valve repair process as an example to illustrate the operation method of the valve clamping 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, and pull the operating wire 501 connected to the clamping arm 64 toward the proximal end to control the clamping arm 64 to retract relative to the fixed base 20, so that the clamping arm 64 is attached to the surface of the fixed base 20; and the control wire 801 connected to the unlocking control member 86 is pulled toward the proximal end so that the locking member 82 releases the lock on the driving shaft 72. Then, the driving shaft 72 is moved toward the proximal end to drive the connecting rod 76 to drive the clamp arm 40 to close relative to the fixed base 20, so that the valve clamping device 100 is in a completely retracted state, and then the tension on the control wire 801 is released, and the push 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 driving shaft 72, and the retracted state of the clamp arm 40 remains unchanged.

[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 tube, through the mitral valve to the left ventricle.

[0080] Step 3: Adjust the relative position of the valve clamping device 100 and the mitral valve so that the valve clamping 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 piece 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 piece 84 pushes the second end 825 of the locking piece 82 to rotate toward the distal end around the first end 823 until the locking piece 82 is locked to the positioning portion 720 of the drive shaft 72.

[0082] Step 5: withdraw the entire valve clamping device 100 toward the proximal end, so that the forceps arm 40 holds 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 leaflets 300 on the atrial side and cooperate with the clamp arm 40 on that side to clamp the valve leaflets (such as Fig.21 shown).

[0084] Step 7: Pull the control wire 801 connected to the unlocking control member 86 toward the proximal end so that the second end 825 of the locking member 82 rotates 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 (such as Fig. 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 leaflet and the posterior leaflet 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 read Fig.23 - Fig. 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 of the locking member 82 and the fixed base 20, and prevent the falling of metal debris 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, Fig. 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 piece 82 in this embodiment contacts the boss 25, which can reduce the friction force when the locking piece 82 and the fixed base 20 rotate relative to each other, that is, reduce the unlocking force of the unlocking control piece 86, and reduce the elastic force of the push piece 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 piece 82 and the inner wall of the fixed base 20, that is, the arc surface 826 contacts the inclined surface 251 and the straight surface of the inner wall of the fixed base 20 at the same time, and the contact line on the straight surface can ensure that the locking piece 82 will not shift during the unlocking process, thereby ensuring the unlocking stability.

[0088] like Fig.23As 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, which can not only reduce the weight of the valve clamping device 100a, but also facilitate the rebound of the clamping arm 64, reduce the difficulty of clamping, and improve the fatigue resistance of the valve clamping device during long-term implantation in the human body, but also reduce the pulling force required to pull the clamping arm 64 up to fit the central axis through the operating wire 501, reduce the reverse force borne by the operating wire 501, prevent the operating wire 501 from breaking, and improve 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 Fig.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 also includes an adjusting member 90, and the adjusting member 90 is arranged outside 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 tissues 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, bolt locking, etc., and the welding connection is adopted in this embodiment.

[0092] The adjusting member 90 includes an elastic body. When the valve clamping device 100b is closed, the elastic body is filled between the anterior leaflet and the posterior leaflet of the clamped mitral valve and abuts against the clamp arm 40. Therefore, it has the following advantages: (1) The elastic body has a buffering effect on the pulsating leaflet, so that the degree of traction of the leaflet by the valve clamping device 100b can be adjusted to avoid damaging the leaflet; (2) The elastic body can be squeezed and deformed following the pulsation of the leaflet, 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 leaflet and the posterior leaflet of the mitral valve is smaller than the opening angle between the clamp arms 40, which can reduce the traction of the leaflet 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 scouring of the blood flow on the inside of the valve clamping device 100b, prevent the valve clamping device 100b from falling off due to continuous scouring of blood, and prevent blood from accumulating in the dead corner between the clamping parts of the valve clamping device 100b to form a thrombus; (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 Fig.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. Among them, the adjusting member 90 with the mesh film 92 can not only increase biocompatibility, avoid tissue allergies and inflammatory reactions, and improve product safety, but also form an artificial barrier on the atrial side of the valve leaflet to block thrombi in the blood, close the opening of the entire valve clamping device 100c toward the atrial side, and avoid repeated flushing of blood in the internal dead corner of the valve clamping device 100c to form thrombi, thereby avoiding thrombi.

[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 member 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 all cover the outside of the adjusting member 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. The results are as follows: Fig.30 As shown:

[0096] Three groups of valve clamping devices were made respectively, of which the first group (A1-A4) is the valve clamping device 100 of the first embodiment of the present invention, the driving shaft 72 is provided with a positioning portion 720, one side of the locking member 82 overlaps the inner wall of the fixed base 20, and a single-sided unlocking control member is adopted. The driving shaft of the valve clamping device of the second group of embodiments (B1-B4) is also provided with a positioning portion, 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 driving shaft has no positioning portion, and one side of the locking member is embedded in the inner wall of the fixed base to fix the connection. The following performance tests were conducted 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 clamping 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, the push shaft on the delivery device 500 is connected to the driving 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, hook the proximal end of the control wire 801 at the moving end of the tensile testing machine, apply an unlocking force to the control wire 801, operate the push shaft at the proximal end of the simple handle, and record 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 piece)

[0102] The locking forces (ie, the locking forces between the drive shaft and the locking member) of the valve clamping 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 piece 82 slip and fail.

[0104] pass Fig.30It can be seen from the test result table that the unlocking force required for the one-sided 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 contents are all described by taking the valve clipper used to alleviate or treat "mitral valve regurgitation" as an example. It is understandable that in other embodiments, the valve clipper can also be used to alleviate or treat "tricuspid valve regurgitation", and its principle and structure are roughly the same as the principle and structure of the valve clipper used to solve "mitral valve regurgitation" in the embodiment of the present invention, and it only needs to form multiple clamps through multiple groups of proximal clips and distal clips, and each clamp clamps a valve leaflet respectively, which will not be described in detail here.

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

[0107] Obviously, in other embodiments, the valve clip provided by the present invention can also be applied to 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: A fixed base, wherein the inner cavity of the fixed base is provided with a boss; At least one pair of clamp arms, the at least one pair of clamp arms are connected to the fixed base and can be opened and closed relative to the fixed base; A driving assembly, the driving assembly comprising a driving shaft movably inserted in the fixed base, the driving shaft moving in the axial direction to drive the clamp arm to open and close relative to the fixed base, and a positioning portion being provided on the outer peripheral surface of the driving shaft; and The locking mechanism comprises a locking piece, a pushing piece and an unlocking control piece, wherein the locking piece has a locking hole opened in the axial direction, the locking piece comprises a first end and a second end opposite to each other, the driving shaft is inserted into the locking hole, the first end of the locking piece abuts the boss, and a gap is formed between the second end of the locking piece and the inner cavity of the fixed base, the pushing piece comprises 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 is bent 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 piece, so that the locking piece is obliquely arranged in the fixed base, so that the edge of the locking hole is clamped on the positioning portion, and the unlocking control piece is connected to the second end of the locking piece, and the unlocking control piece is pulled toward the proximal end so that the second end of the locking piece rotates around the first end.

2. The valve clamping device with a locking mechanism according to claim 1, characterized in that: The positioning portion includes a plurality of grooves and / or protrusions arranged facing the locking hole, and the edge of the locking hole is snap-connected to any groove and / or protrusion.

3. The valve clamping device with a locking mechanism according to claim 2, characterized in that: The plurality of grooves or protrusions are arranged in parallel.

4. The valve clamping device with a locking mechanism according to claim 2, characterized in that: The width of the groove or protrusion is in the range of 0.04-0.30 mm.

5. The valve clamping device with a locking mechanism according to claim 1, characterized in that: The second end can rotate around the first end until the axis of the locking hole is coaxial with the axial direction of the fixing base.

6. The valve clamping device with a locking mechanism according to claim 1, 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 push member abuts against the proximal end surface of the locking member so that the distal end surface of the first end fits against the inclined surface.

7. The valve clamping device with a locking mechanism according to claim 6, characterized in that: The side wall of the first end is a curved surface.

8. The valve clamping device with a locking mechanism according to claim 7, characterized in that: The arc surface contacts the inclined surface and the inner wall of the fixed base at the same time.

9. The valve clamping device with a locking mechanism according to claim 1, characterized in that: The push piece is made of elastic material.

10. The valve clamping device with a locking mechanism according to claim 1, characterized in that: A clamping piece is provided on the first side of the push member, a clamping groove is provided on the inner wall of the fixed base, and the clamping piece is clamped in the clamping groove.

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

12. The valve clamping device with a locking mechanism according to claim 1, characterized in that: The unlocking control member includes a double-line structure, and the double-line structures are arranged side by side and are both sleeved on the second end of the locking member.

13. The valve clamping device with a locking mechanism according to claim 1, characterized in that: The valve clamping device also includes at least one pair of clamping arms, which are arranged between the fixed base and the at least one pair of clamp arms. Each clamping arm cooperates with the clamp arm on a corresponding side to clamp the valve.

14. The valve clamping device with a locking mechanism according to claim 13, characterized in that: The valve clamping device further comprises an adjusting member, which is arranged around the outside of the fixing base.

15. The valve clamping device with a locking mechanism according to claim 14, characterized in that: The adjusting member is made of elastic material, the distal end of the adjusting member is fixedly connected to the fixed base, and the proximal end of the adjusting member is suspended.

16. The valve clamping device with a locking mechanism according to claim 14, characterized in that: The outside and / or inside of the adjusting member, the clamping arm and / or the forceps arm are provided with a biocompatible mesh film.

17. A valve repair system, characterized in that: It comprises the valve clamping device as described in any one of claims 1-16, and also comprises a delivery device detachably connected to the valve clamping device, the delivery device comprises an operating wire, and the distal end of the operating wire is detachably connected to the unlocking control member.

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