Valve Clamper and Valve Repair System

Abstract

The present invention relates to a valve clip and a valve repair system. The valve clip includes a locking mechanism, a plurality of clamping arms, and at least one sliding member. The sliding member is connected to the clamping arms through a pivoting mechanism, so that the clamping arms can be rotated and unfolded or rotated and closed according to the axial sliding of the sliding member. The locking mechanism includes a pulling member, a locking buckle, and a locking bar. The first end of the locking bar is connected to the sliding member or the pivoting mechanism, and the second end of the locking bar is connected to the pulling member. The pulling member is used to drive the locking bar to extend into the locking buckle to cooperate with the locking buckle. The locking bar can prevent the clamping arms from rotating and unfolding when it is in the working condition of cooperating with the locking buckle. When the valve clip proposed by the present invention is locked, there is no need for the operator to apply excessive pulling force, which not only reduces the operation difficulty, but also, because there is no need for unlocking and no need to continuously pull the pulling member after locking, its locking state is more stable and reliable than the prior art, solving the problem of poor reliability of the valve clip.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and particularly relates to a valve clip and a valve repair system. Background Art

[0002] The heart valve refers to the valve between the atrium and the ventricle or between the ventricle and the artery. Among them, the atrioventricular valve includes the mitral valve and the tricuspid valve. The mitral valve is composed of two valve leaflets attached to the periphery of the left atrioventricular orifice and is connected to the papillary muscle by chordae tendineae, which can prevent the blood in the left ventricle from flowing back into the left atrium. Mitral regurgitation is caused by organic or functional changes in the mitral valve leaflets and their related structures, resulting in poor anastomosis of the anterior and posterior leaflets of the mitral valve. When mitral regurgitation occurs, the blood flow will flow back from the left ventricle to the left atrium, causing a series of pathophysiological changes.

[0003] Surgical valve repair or replacement is considered the standard treatment for such diseases. However, surgery has the disadvantages of large trauma, obvious postoperative pain, slow recovery, and high risk. In recent years, the interventional treatment of heart valve disease has developed rapidly due to its advantages of less trauma, relatively safe, and good curative effect. Among them, the valve repair method developed based on the principle of surgical valve edge-to-edge suture technology has been affirmed due to its high safety, simple technical principle, and high feasibility. During this operation, the valve repair system needs to be dissociated after the clamping arms of the valve clip are locked, and the valve clip is left in the patient's body.

[0004] In the related art, the locking mechanism of the valve clip includes a limit frame, a baffle, and an arched elastic sheet. In the locked state, the arched elastic sheet abuts against the baffle and applies a force to the baffle, causing the baffle to tilt and tightly clamp the sliding member. When unlocking, the operator needs to pull the baffle to make the baffle return to the horizontal state and no longer clamp the sliding member. However, since pulling the baffle during unlocking needs to overcome the elastic force applied by the arched elastic sheet, a large pulling force is required, which is easily damaged or even broken, and there is a risk of failure. Therefore, the existing valve clip has poor reliability. Summary of the Invention

[0005] The purpose of the present invention is to at least solve the problem of poor reliability of the valve clip. This purpose is achieved by the following technical solutions:

[0006] In the first aspect of the present invention, a valve clip is proposed, and the valve clip includes:

[0007] A plurality of clamping arms;

[0008] At least one sliding member, the sliding member is connected to the clamping arm through a pivoting mechanism, so that the clamping arm rotates and unfolds or rotates and closes according to the axial sliding of the sliding member;

[0009] Locking mechanism, the locking mechanism includes a pulling member, a locking buckle and a locking bar, the first end of the locking bar is connected to the sliding member or the pivoting mechanism, the second end of the locking bar is connected to the pulling member, and the pulling member is used to drive the locking bar to extend into the locking buckle to cooperate with the locking buckle. The locking bar can prevent the clamping arm from rotating and unfolding under the condition of cooperating with the locking buckle.

[0010] The valve clip of the embodiment of the present invention has the following advantages:

[0011] In the valve clip of the embodiment of the present invention, the locking bar is not engaged with the locking buckle in the initial state. At this time, the clamping arm can be freely opened and closed under the drive of the sliding member; when the clamping arm needs to be locked after clamping, the operator can use the pulling member to pull the second end of the locking bar to make it extend into the locking buckle and cooperate with the locking buckle. Since the first end of the locking bar is connected to the sliding member or the pivoting mechanism, the locking bar after cooperating with the locking buckle can restrict the movement of the sliding member or the pivoting mechanism, so that the clamping arm cannot rotate and unfold. When the valve clip of this embodiment is locked, the operator does not need to apply too much pulling force, which not only has a low operation difficulty, but also because there is no need to unlock in the initial state and there is no need to continuously pull the pulling member after locking, its locking state is more stable and reliable than the prior art, solving the problem of poor reliability of the valve clip.

[0012] In addition, the valve clip according to the embodiment of the present invention may also have the following technical features:

[0013] In some embodiments of the present invention, the locking buckle includes a housing and at least one rolling body. A conical channel is provided in the housing, and the rolling body is axially movably arranged in the conical channel. Under the condition that the locking bar cooperates with the locking buckle, the rolling body is in rolling contact with the inner wall of the conical channel and the locking bar.

[0014] In some embodiments of the present invention, the rolling body is set as a sphere or a cylinder.

[0015] In some embodiments of the present invention, a first opening and a second opening communicating with the conical channel are respectively provided at both axial ends of the housing. The area of the first opening is smaller than the area of the second opening. The locking bar is arranged to extend into the conical channel from the first opening and extend out from the second opening.

[0016] In some embodiments of the present invention, the cross-sectional area of the conical channel gradually decreases in the direction from the proximal end to the distal end, and / or the conical channel includes a planar side wall and a conical side wall, and the planar side wall and the conical side wall enclose a conical space.

[0017] In some embodiments of the present invention, the valve clip also includes a central shaft tube, the plurality of clip arms are wound around the periphery of the central shaft tube, the sliding member is slidably disposed within the central shaft tube, and the locking buckle is connected to the central shaft tube.

[0018] In some embodiments of the present invention, the pivoting mechanism includes a base and a linkage arm. The linkage arm is rotatably connected to the base and the clip arm respectively. The base is fixedly connected to the sliding member. The first end of the locking bar is connected to the base, and the second end of the locking bar is capable of moving proximally and extending into the locking buckle.

[0019] In some embodiments of the present invention, at least a portion of the locking bar is in a bent state, and the locking bar elastically deforms according to the pulling of the pulling member.

[0020] In some embodiments of the present invention, the pulling member is provided as a wire or a non-metallic wire.

[0021] A second aspect of the present invention provides a valve repair system. The valve repair system includes the valve clip according to any one of the above embodiments and a delivery device. The delivery device is detachably connected to the valve clip to deliver the valve clip to a set position. The delivery device includes at least one driving member, and the driving member is connected to the sliding member of the valve clip to drive the sliding member to slide.

[0022] The valve repair system provided by the embodiments of the present invention has the same advantages as the valve clip according to any one of the above embodiments, and will not be described in detail herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] The following briefly introduces the drawings in the embodiments. Those skilled in the art can also obtain other drawings based on these drawings without creative efforts.

[0024] Figure 1 Structural schematic of the valve clip (one sliding member) according to an embodiment of the present invention Figure 1 ;

[0025] Figure 2 Structural schematic of the valve clip (one sliding member) according to an embodiment of the present invention Figure 2 ;

[0026] Figure 3 Structural schematic of the valve clip (two sliding members) according to an embodiment of the present invention Figure 1 ;

[0027] Figure 4 Structural schematic of the valve clip (two sliding members) according to an embodiment of the present invention Figure 2 ;

[0028] Figure 5 is Figure 3 a partial structural schematic diagram of the valve clip applicator shown, including a locking mechanism;

[0029] Figure 6 is Figure 4 a partial structural schematic diagram of the valve clip applicator shown, including a locking mechanism;

[0030] Figure 7 is Figure 5 the front view of

[0031] Figure 8 is Figure 7 the cross-sectional view in the A-A direction of

[0032] Figure 9 is Figure 6 the front view of

[0033] Figure 10 is Figure 9 the cross-sectional view in the B-B direction of

[0034] Figure 11 is the structural schematic diagram of the valve repair system according to the embodiment of the present invention;

[0035] Figure 12 is the cross-sectional schematic diagram of the cooperation between the driving member and the sliding member in the valve repair system according to the embodiment of the present invention.

[0036] The reference signs in the drawings are shown as follows:

[0037] 1000, valve repair system;

[0038] 100, valve clip applicator;

[0039] 10, locking mechanism; 11, pulling member; 12, locking buckle; 121, housing; 1211, conical channel; 1212, first opening; 1213, second opening; 1214, retaining cover; 122, rolling body; 13, locking bar; 131, connecting hole;

[0040] 20, clamping arm; 201, avoidance groove; 202, connecting ear;

[0041] 30, sliding member; 31, first sliding rod; 32, second sliding rod; 33, sliding cylinder;

[0042] 40, pivoting mechanism; 41, base; 411, first base; 412, second base; 42, linkage arm;

[0043] 50, central shaft cylinder; 51, mounting seat;

[0044] 60, capturing member;

[0045] 710. Handle; 720. Sheath tube; 730. Bending adjustment mechanism; 740. Driving member. Detailed implementation manner

[0046] As described in the background art, taking the mitral valve repair surgery as an example, after the clamping arms of the valve clip close the valve, locking is required, that is, preventing the clamping arms from rotating and unfolding. In some existing valve clips, the locking mechanism uses an arched elastic piece to apply a force to the baffle plate, and realizes locking by clamping the sliding member when the baffle plate is tilted. When in use, the operator needs to first pull the baffle plate to unlock through the pulling wire, which is not only inconvenient to operate, but also because the elastic force generated by the arched elastic piece needs to be overcome, it is easy to cause damage or even breakage of the pulling wire, and then lead to the failure of the valve clip. To solve the above problems, the present invention proposes a valve clip and a valve repair system. By providing a locking buckle and a locking strip in the valve clip, the locking strip does not cooperate with the locking buckle in the initial state. At this time, the clamping arms can be freely opened and closed under the drive of the sliding member; when the clamping arms need to be locked after clamping, the operator can use the pulling member to pull one end of the locking strip to make it extend into the locking buckle and cooperate with the locking buckle. Thus, by restricting the movement of the sliding member or the pivoting mechanism connected to the locking strip, the clamping arms cannot rotate and unfold. This not only reduces the operation difficulty, but also has stable locking and good reliability.

[0047] The following will be combined with the drawings in the embodiments of the present invention. The terms used in the text are only for the purpose of describing specific exemplary embodiments and cannot be understood as a limitation of the present invention. For example, the terms "including" and "having" not only indicate the existence of the stated features, but also do not exclude the existence of other features; the terms "first" and "second" do not imply order or sequence; the terms "inside", "outside", "above", and "below" are only for the convenience of describing the relationship of one feature shown in the drawings relative to another feature, and do not indicate that it must have a specific orientation. It should be noted that in the field of interventional medical devices, the proximal end refers to the end closer to the operator, and the distal end refers to the end farther from the operator; the axial direction refers to the direction parallel to the line connecting the centers of the distal end and the proximal end of the medical device in the natural state. In the description of the present invention, the above definitions are only for the convenience of expression and cannot be understood as a limitation of the present invention.

[0048] Please refer to Figures 1 to 4, an embodiment of the present invention provides a valve clip 100, which includes a locking mechanism 10, a plurality of clamping arms 20 and at least one sliding member 30. The sliding member 30 is connected to the clamping arms 20 through a pivoting mechanism 40, so that the clamping arms 20 can be rotated and unfolded or rotated and closed according to the axial sliding of the sliding member 30; the locking mechanism 10 includes a pulling member 11, a locking buckle 12 and a locking bar 13. The first end of the locking bar 13 is connected to the sliding member 30 or the pivoting mechanism 40, and the second end of the locking bar 13 is connected to the pulling member 11. The pulling member 11 is used to drive the locking bar 13 to extend into the locking buckle 12 to cooperate with the locking buckle 12. The locking bar 13 can prevent the clamping arms 20 from rotating and unfolding under the condition of cooperating with the locking buckle 12.

[0049] The valve clip 100 provided in this embodiment can be used as an edge-to-edge repair implant in the field of interventional treatment of heart diseases. The valve clip 100 provided in this embodiment can reach the designated position through a minimally invasive percutaneous access and blood vessels, and realize the repair treatment of heart valves (including but not limited to mitral valve, tricuspid valve, aortic valve, pulmonary valve). It can be understood that since the valve clip 100 needs to lock the clamping arms 20 to keep the clamping state after clamping the heart valve in order to stay in the patient's body, the valve clip 100 has relatively high requirements for locking stability. In this embodiment, one end of the locking bar 13 can be connected to the sliding member 30 or the pivoting mechanism 40. When the locking bar 13 is not cooperating with the locking buckle 12, the clamping arms 20 can freely open and close with the sliding of the sliding member 30 without unlocking; the other end of the locking bar 13 can be pulled by the pulling member 11 to extend into the locking buckle 12 and cooperate with the locking buckle 12. After cooperating with the locking buckle 12, the locking bar 13 cannot move, or at least cannot move in a set direction. Here, the set direction means that if the locking bar 13 moves along this direction, it will not be able to prevent the sliding member 30 from sliding in the direction of driving the clamping arms 20 to rotate and unfold. Therefore, the locking bar 13 after cooperating with the locking buckle 12 can limit the movement of the sliding member 30 or the rotation of the pivoting mechanism 40. Therefore, after the clamping arms 20 are clamped, the operator can use the pulling member 11 to drive the locking bar 13 to cooperate with the locking buckle 12, thereby restricting the unfolding of the clamping arms 20 and realizing the locking of the clamping arms 20. Since the pulling member 11 does not need to use too much force when pulling the locking bar 13, it is convenient for the operator to pull. Moreover, after the locking bar 13 cooperates with the locking buckle 12, it can be kept in the cooperating state without the pulling member 11 continuing to pull, which is more stable and reliable than the prior art, and solves the problem of poor reliability of the valve clip 100.

[0050] Please continue to refer to Figures 1 to 4, in the valve clip 100 proposed in this embodiment, the sliding member 30 can slide axially, thereby driving the clip arms 20 to rotate and unfold or close. The linkage relationship between the sliding member 30 and the clip arms 20 will be specifically described in the following embodiments regarding the overall structure and principle of the valve clip 100. In this embodiment, the locking mechanism 10 includes a pulling member 11, a locking buckle 12, and a locking bar 13. The operator uses the pulling member 11 to change the position of the locking bar 13, so that the locking bar 13 moves from the initial position into the locking buckle 12, thereby cooperating with the locking buckle 12. The cooperation between the locking bar 13 and the locking buckle 12 includes but is not limited to the following two situations. One is two-way locking, that is, the locking bar 13 is clamped inside the locking buckle 12 and cannot continue to move or retreat; the other is one-way locking. The locking bar 13 is restricted by the locking buckle 12 and can only continue to move in the forward direction and cannot move backward. It should be noted that in this situation, the backward direction is the aforementioned set direction. If the locking bar 13 moves backward, it will not be able to prevent the sliding member 30 from sliding in the direction of driving the clip arms 20 to rotate and unfold. This embodiment does not specifically limit the cooperation method between the locking bar 13 and the locking buckle 12.

[0051] On the basis of the above embodiment, after the locking bar 13 cooperates with the locking buckle 12, the sliding member 30 cannot slide or can only not slide in the direction of driving the clip arms 20 to unfold. Correspondingly, the clip arms 20 cannot rotate at all or can only not rotate in the unfolding direction. It can be understood that since the locking mechanism 10 locks the clip arms 20 after the clip arms 20 are closed, the above two situations can both achieve the effect of preventing the clip arms 20 from unfolding. Exemplarily, if the sliding member 30 slides distally to drive the clip arms 20 to unfold and slides proximally to drive the clip arms 20 to close, then when the locking bar 13 cooperates with the locking buckle 12, the sliding member 30 at least cannot slide distally, and the locking bar 13 can at least prevent the sliding member 30 from sliding distally.

[0052] Please continue to refer to Figures 1 to 4 , and in combination with referring to Figure 5 and Figure 6 , in this embodiment, the locking bar 13 is a long strip-shaped sheet structure with a certain thickness. For example, it can be a rectangular sheet structure or an oval sheet structure. The initial state of the locking bar 13 can be set to a straight state, a bent state, or a state with part straight and part bent. Specifically, it can be set according to the connection relationship and relative position relationship with other components in the valve clip 100. When the locking bar 13 extends into the locking buckle 12 and cooperates with the locking buckle 12, the bent locking bar 13 can be converted into a straight state through deformation to cooperate with the locking buckle 12. In this embodiment, the material of the locking bar 13 can be selected as a shape memory alloy such as nickel-titanium alloy.

[0053] In some embodiments of the present invention, the cooperation between the locking bar 13 and the locking buckle 12 is set for two-way locking. Exemplarily, a groove is provided in the locking buckle 12, and an elastic protrusion is provided on the locking bar 13. When the locking bar 13 extends into the locking buckle 12, the elastic protrusion is compressed and contracted. After the locking bar 13 extends into the locking buckle 12, the elastic protrusion automatically pops out and gets stuck in the groove, thereby realizing the clamping cooperation between the locking bar 13 and the locking buckle 12. In some other embodiments of the present invention, please refer to Figures 7 to 10 , the cooperation between the locking bar 13 and the locking buckle 12 is set for one-way locking. Exemplarily, the locking buckle 12 includes a housing 121 and at least one rolling body 122. A tapered channel 1211 is provided in the housing 121. The rolling body 122 is axially movably arranged in the tapered channel 1211. After the locking bar 13 extends in, the rolling body 122 can rollingly contact the locking bar 13 at a certain critical position and restrict the backward movement of the locking bar 13.

[0054] Based on the above embodiments, please continue to refer to Figures 7 to 10 , the locking bar 13 extends into the locking buckle 12 from the smaller end of the tapered channel 1211. During the extension process of the locking bar 13, the rolling body 122 is pushed by the locking bar 13 to the above critical position. At this time, the rolling body 122 is stuck between one inner wall of the tapered channel 1211 and the locking bar 13, and respectively makes rolling contact with the inner wall of the tapered channel 1211 and the locking bar 13. As the locking bar 13 continues to move, the rolling body 122 rolls at this position and no longer moves. At the same time, the locking bar 13 is stuck between the rolling body 122 and the other inner wall of the tapered channel 1211 and cannot retreat, that is, both of them cannot move towards the smaller end of the tapered channel 1211, realizing one-way locking.

[0055] Specifically, as Figures 7 to 10 shown, the cross-sectional area of the tapered channel 1211 gradually changes along the axial direction, which can be a uniform change or a non-uniform change. That is to say, the side wall of the tapered channel 1211 can be a planar side wall or a non-planar side wall. On this basis, the first opening 1212 and the second opening 1213 are respectively provided at the two axial ends of the housing 121. The first opening 1212 and the second opening 1213 are communicated with the tapered channel 1211. Along the direction from the first opening 1212 to the second opening 1213, the cross-sectional area of the tapered channel 1211 gradually increases, and the locking bar 13 can extend into the tapered channel 1211 from the first opening 1212 and extend out from the second opening 1213. It can be understood that since the locking bar 13 will push the rolling body 122 to move after extending into the tapered channel 1211, extending the locking bar 13 from the smaller end can ensure that the rolling body 122 moves towards the direction where the cross-section of the tapered channel 1211 increases, thereby ensuring that the locking bar 13 can continue to extend.

[0056] According to the above-described embodiments, when the rolling element 122 is pushed to the critical position, the rolling element 122 can no longer move further toward the second opening 1213. It should be noted here that there are various ways to prevent the rolling element 122 from moving toward the second opening 1213. In an alternative embodiment, as Figure 8 and Figure 10 show, the cross-sectional area of the tapered channel 1211 gradually decreases in the direction from the proximal end to the distal end. That is to say, the first opening 1212 is closer to the distal end than the second opening 1213. Since the first opening 1212 is located below the second opening 1213 during the surgical process, that is, the tapered channel 1211 has a wider upper part and a narrower lower part. Thus, in the initial state, the rolling element 122 contacts the opposite inner walls of the tapered channel 1211 respectively, that is, it is stuck at a position near the first opening 1212 of the tapered channel 1211. When the locking bar 13 just extends into the tapered channel 1211, the end of the locking bar 13 can push the rolling element 122, and as the locking bar 13 moves, the rolling element 122 will move accordingly until it reaches the critical position. Since the channel cross-section becomes larger, the locking bar 13 moves to the side of the rolling element 122 and no longer applies a thrust to the rolling element 122. And at this time, the locking bar 13 is located between the rolling element 122 and the inner wall of the tapered channel 1211. Moreover, due to the influence of its own gravity, the rolling element 122 always has a tendency to fall back toward the first opening 1212. Therefore, the rolling element 122 will contact the locking bar 13 at the critical position. Thus, when the locking bar 13 continues to move toward the second opening 1213, the rolling element 122 can roll along with its movement and will not move toward the second opening 1213.

[0057] Based on the above-described embodiments, as Figure 5 and Figure 6 show, a retaining cover 1214 is further provided at one end of the locking buckle 12 where the second opening 1213 is located. The retaining cover 1214 can be integrally formed on the locking buckle 12. In this embodiment, the retaining cover 1214 seals the second opening 1213, which can prevent the rolling element 122 inside the locking buckle 12 from falling off. And an opening for the locking bar 13 to extend out is provided on the retaining cover 1214. The shape of the opening can be the same as the cross-sectional shape of the locking bar 13, and the area of the opening is slightly larger than the cross-sectional area of the locking bar 13 to ensure that the locking bar 13 can extend out.

[0058] In another alternative embodiment, the second opening 1213 is closer to the distal end than the first opening 1212, that is, when the valve clip 100 is in a vertical state during the operation, the second opening 1213 is located below the first opening 1212, and the conical channel 1211 has a shape that is narrower at the top and wider at the bottom. To prevent the rolling body 122 from moving towards the second opening 1213 due to gravity, an elastic member, such as a spring, can be provided in the conical channel 1211, and the spring is arranged between the rolling body 122 and the second opening 1213. Thus, by providing a certain supporting force to the rolling body 122, the rolling body 122 is prevented from continuing to move towards the second opening 1213 after reaching the critical position. The interaction relationship between the locking strip 13 and the rolling body 122 is the same as that in the foregoing embodiment and will not be elaborated herein.

[0059] Further, in this embodiment, one or more rolling bodies 122 can be provided. In some embodiments of the present invention, the rolling body 122 can be provided as a sphere or a cylinder. This embodiment does not make any limitation in this regard, as long as the rolling body 122 can be unidirectionally locked with the locking strip 13 at the critical position. In this embodiment, there are various setting methods for the shape of the housing 121 of the locking buckle 12. For example, the housing 121 can be provided as a conical cylinder or a rectangular cylinder. The rectangular cylinder-shaped housing 121 has a local protrusion or local indentation to form the conical channel 1211. This embodiment does not make any limitation in this regard. In some embodiments of the present invention, as Figure 8 and Figure 10 shown, the housing 121 includes a planar side wall and a conical side wall. The planar side wall is connected to the conical side wall and together encloses a conical space. When the locking strip 13 extends into the locking buckle 12, it can extend along the planar side wall, so that there is no need to adjust the angle and direction when the locking strip 13 moves, and it is only necessary to pull the locking strip 13 axially, which is convenient for the operator to operate.

[0060] The following description is made in combination with the overall structure of the valve clip 100. Please refer to Figures 1 to 4 , in this embodiment, a plurality of clamping arms 20 are provided. Exemplarily, if the valve clip 100 is applied to mitral valve repair treatment, the number of clamping arms 20 can be correspondingly set to two. If the valve clip 100 is applied to tricuspid valve repair treatment, the number of clamping arms 20 can be correspondingly set to three; correspondingly, in this embodiment, the number of sliding members 30 can be set to one or more, and each sliding member 30 can be connected to one or more clamping arms 20 through a pivoting mechanism 40. Exemplarily, the number of sliding members 30 is set to one, and this sliding member 30 is respectively connected to two clamping arms 20 through a pivoting mechanism 40, or the number of sliding members 30 is set to two, and each sliding member 30 is connected to one clamping arm 20 through a pivoting mechanism 40. This embodiment does not make specific limitations on the number of the sliding members 30 and the clamping arms 20, and can be set according to actual needs.

[0061] Further, please continue to refer to Figures 1 to 4 , in some embodiments of the present invention, the valve clip 100 further includes a central shaft cylinder 50. The central shaft cylinder 50 is located at the middle position of the valve clip 100. The sliding member 30 is slidably disposed within the central shaft cylinder 50. A plurality of clip arms 20 are wound around the periphery of the central shaft cylinder 50. One end of the clip arm 20 is rotatably connected to the central shaft cylinder 50. When the sliding sliding member 30 is in linkage with the clip arm 20, the clip arm 20 can rotate around the connection with the central shaft cylinder 50. In an alternative embodiment, when the sliding member 30 slides distally, the clip arm 20 rotates and unfolds. When the sliding member 30 slides proximally, the clip arm 20 rotates and closes.

[0062] In this embodiment, the central shaft cylinder 50 is provided as a cylindrical structure with a cavity inside; the shape of the clip arm 20 can be set as a long strip plate shape, for example, it can be set as an arc-shaped plate. The distal end of the clip arm 20 is rotatably connected to the central shaft cylinder 50, and the inner arc surface of the clip arm 20 faces the central shaft cylinder 50. When the number of clip arms 20 is two, the two clip arms 20 are symmetrically arranged on both sides of the central shaft cylinder 50. After the two clip arms 20 are closed, they are in a hugging state, so as to facilitate clamping of the valve. An avoidance groove 201 is provided at a position of the clip arm 20 close to the distal end. Two connecting ears 202 are provided at the distal end of the clip arm 20. The two connecting ears 202 are respectively located on both sides of the avoidance groove 201 and extend to the outer wall of the central shaft cylinder 50 to be connected to the central shaft cylinder 50. Exemplarily, they can be rotatably connected through a rotating shaft.

[0063] Based on the above embodiment, please continue to refer to Figure 3 and Figure 4 , and in combination with reference to Figures 7 to 10 , the locking buckle 12 is connected to the central shaft cylinder 50. For example, it can be connected through a mounting seat 51. As shown in Figure 3 , a mounting seat 51 can be provided on the central shaft cylinder 50. The mounting seat 51 can be provided on the outer wall of the central shaft cylinder 50 by welding or integrally molding. The locking buckle 12 is connected to the mounting seat 51, and the connection method can be welding. It can be understood that since the outer wall of the central shaft cylinder 50 is a cylindrical surface, in this embodiment, the connection method of the locking buckle 12 to the central shaft cylinder 50 through the mounting seat 51 not only facilitates assembly but also improves the connection reliability between the locking buckle 12 and the central shaft cylinder 50.

[0064] Based on the above embodiment, as shown in Figure 1 and Figure 3As shown, the pivot mechanism 40 is connected between the sliding member 30 and the clamping arm 20. The pivot mechanism 40 drives the clamping arm 20 to rotate around the connection with the central shaft cylinder 50 according to the sliding of the sliding member 30. In some embodiments of the present invention, one end of the pivot mechanism 40 is fixedly connected to the sliding member 30, and the other end is rotatably connected to the clamping arm 20. Exemplarily, when the sliding member 30 slides axially towards the distal end, the pivot mechanism 40 moves towards the distal end accordingly, and drives the clamping arm 20 rotatably connected thereto to rotate away from the central shaft cylinder 50, that is, drives the clamping arm 20 to open; when the sliding member 30 slides axially towards the proximal end, the pivot mechanism 40 moves towards the proximal end accordingly, and drives the clamping arm 20 rotatably connected thereto to rotate towards the central shaft cylinder 50, that is, drives the clamping arm 20 to close.

[0065] Please continue to refer to Figures 1 to 4 , in some embodiments of the present invention, the pivot mechanism 40 includes a base 41 and a linkage arm 42. The base 41 is fixedly connected to the sliding member 30. Exemplarily, in some embodiments of the present invention, the sliding member 30 extends from the distal end of the central shaft cylinder 50, and the base 41 can be connected to the end of the sliding member 30, thereby being able to expand the movement range of the base 41, and further expanding the opening and closing range of the clamping arm 20. Further, the linkage arm 42 in the pivot mechanism 40 is respectively rotatably connected to the base 41 and the clamping arm 20. When the base 41 slides axially with the sliding member 30, the linkage arm 42 rotates between the base 41 and the clamping arm 20, and further drives the clamping arm 20 to rotate. Exemplarily, the end of the linkage arm 42 away from the base 41 is rotatably connected to the middle part of the clamping arm 20, so that the linkage arm 42 can apply a pulling force or a pushing force to the clamping arm 20 when rotating, and further drive the clamping arm 20 to rotate to achieve opening or closing.

[0066] Further, on the basis of the above-mentioned embodiments, the first end of the locking bar 13 in this embodiment can be connected to the sliding member 30, or can be connected to the base 41 or the linkage arm 42 in the pivot mechanism 40. Exemplarily, the first end of the locking bar 13 can be connected to the part of the sliding member 30 extending out of the central shaft cylinder 50, or can be connected to the sliding member 30 by extending into the central shaft cylinder 50 from a window provided on the side wall of the central shaft cylinder 50, or can also be connected to the base 41 provided at the distal end of the sliding member 30. Exemplarily, as Figure 1 and Figure 3 shown, the base 41 is connected to the distal end of the sliding member 30, and the first end of the locking bar 13 is fixedly connected to the base 41, and the connection method can be specifically set as welding.

[0067] According to the above embodiments, since the locking buckle 12 is connected to the central shaft cylinder 50 and fixed, when the clamping arms 20 are in the closed state, the distance between the locking buckle 12 and the base 41 is small, and the whole locking bar 13 is located between the locking buckle 12 and the base 41. On this basis, as Figure 1 and Figure 3 shown, the locking bar 13 is in a bent state before cooperating with the locking buckle 12. The bent state can be a spiral bend or an S-shaped curl. This embodiment does not make specific limitations on this, and the locking bar 13 can produce elastic deformation when being pulled by the pulling member 11. That is to say, under the condition that the clamping arms 20 are closed, the locking bar 13 curls and contracts between the base 41 and the locking buckle 12. When locking is required, the operator pulls the second end of the locking bar 13 through the pulling member 11 to make the locking bar 13 undergo elastic deformation. As Figure 2 and Figure 4 shown, the locking bar 13 can change from the bent state to the straight state, and then extend into and cooperate with the locking buckle 12.

[0068] Further, on the basis of the above embodiments, please continue to refer to Figure 1 and Figure 3 , and in combination with referring to Figure 4 and Figure 5 , the pulling member 11 is connected to the second end of the locking bar 13 and can change the shape of the locking bar 13 by pulling so that it extends into the locking buckle 12. In this embodiment, the pulling member 11 can be pre-passed through the locking buckle 12. That is to say, when the valve clip 100 is assembled, the distal end of the pulling member 11 first penetrates into the conical channel 1211 of the locking buckle 12 and passes out from the conical channel 1211 and then is connected to the locking bar 13 to ensure that the locking bar 13 can extend into the locking buckle 12. In some embodiments of the present invention, the pulling member 11 is set as a metal wire or a non-metal wire, such as a nylon wire or a suture. Exemplarily, as Figure 5 and Figure 6 shown, a connection hole 131 can be provided at the second end of the locking bar 13, and the pulling member 11 passes through the connection hole 131 and is connected to the locking bar 13. Further, the number of the connection holes 131 can be set to one or two. When there is one connection hole 131, the pulling member 11 penetrates into the proximal side of the connection hole 131, passes out from the distal side and extends towards the proximal end; when there are two connection holes 131, the pulling member 11 can penetrate into the proximal side of one of the connection holes 131, pass out from the distal side, then penetrate into the distal side of the other connection hole 131, pass out from the proximal side and extend towards the proximal end. Such a method is convenient for the pulling member 11 to withdraw after locking.

[0069] In some embodiments of the present invention, please continue to refer to Figures 1 to 4, the valve clip 100 further includes a capturing member 60. The capturing member 60 is installed between the central shaft cylinder 50 and the clamping arms 20. Barbs are provided on the side of the capturing member 60 facing the clamping arms 20 to capture the valve. Correspondingly, the valve clip 100 further includes a control wire connected to the capturing member 60, such as a suture or a wire. The control wire is used to drive the capturing member 60 to rotate. Thus, during the process of the valve clip 100 clamping the valve, the valve can be captured by the capturing member 60 first, and then clamped by the clamping arms 20. Exemplarily, the capturing member 60 can be set as a capturing spring piece formed by processing a shape memory alloy such as nickel-titanium alloy material. The capturing spring piece includes a plurality of bullet pieces, for example, two bullet pieces located on both sides of the central shaft cylinder 50 respectively. The two bullet pieces can be set as an integrally formed structure, and there is a set included angle between them. One control wire can be provided and used to control the two bullet pieces simultaneously, or multiple control wires can be provided, and each control wire is connected to and controls one bullet piece. In this embodiment, by providing barbs on the capturing member 60, it is convenient for the capturing member 60 to capture the valve when contacting the valve, and the accuracy of subsequent clamping by the clamping arms 20 is improved.

[0070] On the basis of the above-mentioned embodiment, the valve clip 100 includes one or more sliding members 30. The sliding members 30 are slidably arranged along the axial direction in the central shaft cylinder 50. Each sliding member 30 can drive one or more clamping arms 20 to rotate. In this embodiment, one or more locking mechanisms 10 can be provided. The locking bar 13 of the locking mechanism 10 is connected to one or more sliding members 30, or is matingly connected to the bases 41 of one or more pivoting mechanisms 40. And according to the different numbers of the sliding members 30 and the bases 41, the cooperation modes between the locking bar 13 and the sliding members 30 or the bases 41 are also different.

[0071] In an alternative embodiment, as Figure 1 and Figure 2 shown, the number of the sliding members 30 is set to one. For example, the sliding member 30 is set as the first sliding rod 31. The first sliding rod 31 is slidably arranged in the central shaft cylinder 50. The distal end of the first sliding rod 31 extends out from the distal end of the central shaft cylinder 50. The valve clip 100 includes two clamping arms 20 and two pivoting mechanisms 40. For the specific structures of the clamping arms 20 and the pivoting mechanisms 40, refer to the foregoing embodiment, and details are not described herein again. In this embodiment, the two linkage arms 42 of the two pivoting mechanisms 40 are connected to a base 41, and this base 41 is connected to the distal end of the first sliding rod 31. On this basis, the first end of the locking bar 13 can be connected to the side of the first sliding rod 31 outside the central shaft cylinder 50, or can be connected to the base 41. Thus, when the second end of the locking bar 13 extends into the locking buckle 12, the first sliding rod 31 cannot move towards the distal end, that is, the locking of the first sliding rod 31 is achieved, and further the rotation and unfolding of the two clamping arms 20 are prevented.

[0072] In another alternative embodiment, the number of sliding members 30 is set to be plural. The plural sliding members 30 include a sliding rod and at least one sliding cylinder 33 sleeved outside the sliding rod. In this embodiment, one locking mechanism 10 is provided and is matched with the sliding rod. Exemplarily, as Figure 2 and Figure 3 shown, taking the number of sliding cylinders 33 being set to one as an example, the plural sliding members 30 include a second sliding rod 32 and a sliding cylinder 33. The sliding cylinder 33 is slidably arranged in the central shaft cylinder 50, the second sliding rod 32 is slidably arranged in the sliding cylinder 33, the distal end of the sliding cylinder 33 extends out from the distal end of the central shaft cylinder 50, and the distal end of the second sliding rod 32 extends out from the distal end of the sliding cylinder 33. The valve clip 100 includes two clamping arms 20 and two pivoting mechanisms 40. Each pivoting mechanism 40 includes a base 41 and a linkage arm 42. For the specific structures of the clamping arm 20, the base 41, and the linkage arm 42, refer to the foregoing embodiments and will not be elaborated herein. The two bases 41 are respectively a first base 411 and a second base 412. The first base 411 is connected to the sliding cylinder 33, and the second base 412 is connected to the second sliding rod 32. Exemplarily, the second base 412 can be connected to the rod section of the second sliding rod 32 or the end of the second sliding rod 32. On this basis, the first end of the locking bar 13 can be connected to the part of the second sliding rod 32 outside the sliding cylinder 33 or the second base 412. It can be understood that in this embodiment, the second base 412 is located on the side close to the distal end of the first base 411. Therefore, after the locking bar 13 is engaged with the locking buckle 12, the second sliding rod 32 and the second base 412 cannot move towards the distal end, and correspondingly, the first base 411 and the sliding cylinder 33 cannot move towards the distal end either, that is, the locking of the second sliding rod 32 and the sliding cylinder 33 is achieved, thereby preventing the two clamping arms 20 from rotating and unfolding.

[0073] Please refer to Figure 11, an embodiment of the second aspect of the present invention provides a valve repair system 1000. The valve repair system 1000 includes a delivery device and a valve clip 100 according to any of the above embodiments. The delivery device is detachably connected to the valve clip 100, and the delivery device is used to deliver the valve clip 100 to a set position. In this embodiment, the delivery device includes a handle 710, a sheath assembly, and a connection mechanism. The sheath assembly includes a bending mechanism 730 and a plurality of sheaths 720 sleeved in sequence. The handle 710 is connected to the sheath assembly and can control some or all of the sheaths 720 in the sheath assembly to reach a set position in the patient's body. The bending mechanism 730 can control some or all of the sheaths 720 in the sheath assembly to bend at the set position. The pulling member 11 of the locking mechanism 10 in the valve clip 100 can be connected to the handle 710, so as to facilitate the operator to operate the pulling member 11 through the handle 710; the connection mechanism is connected to the distal end of the innermost sheath 720 and is used for detachably connecting to the valve clip 100. Thus, when the valve clip 100 is delivered to the set position, the valve clip 100 adjusts its position according to the bending and movement of the sheath 720. After the valve clip 100 clamps the valve and locks, the connection mechanism is dissociated from the valve clip 100. After the sheath assembly is withdrawn, the valve clip 100 remains in the patient's body.

[0074] Further, please continue to refer to Figure 11 , and in combination with referring to Figure 12 , in some embodiments of the present invention, the delivery device includes at least one driving member 740. The driving member 740 is connected to the sliding member 30 to drive the sliding member 30 to slide. In this embodiment, the number of driving members 740 is set according to the number of sliding members 30. Exemplarily, when the sliding member 30 is set to one, the driving member 740 is also set to one. According to the above embodiment, a channel is provided in the innermost sheath 720 of the sheath assembly. The driving member 740 is disposed in the channel. The distal end of the driving member 740 extends out from the distal end of the sheath 720 and cooperates with the sliding member 30 of the valve clip 100. Thus, the operator can pull or push the driving member 740 to realize pulling or pushing the sliding member 30, so that the sliding member 30 slides axially.

[0075] Taking the sliding member 30 being set as the first sliding rod 31 as an example, as Figure 12As shown, a blind hole is provided at one end of the first slide bar 31 near the proximal end, and internal threads are provided in the blind hole. The driving member 740 can specifically be set as a wire. External threads that match the above internal threads are provided on the outer wall of the driving member 740 near the distal end. Thus, the distal end of the driving member 740 is connected to the sliding member 30, and the proximal end of the driving member 740 can be connected to the handle 710. The operator can control the movement and rotation of the driving member 740 through the handle 710. It can be understood that when the sliding member 30 needs to move axially, the operator can move the driving member 740 through the handle 710. When the delivery device needs to be disengaged from the valve clip 100, the operator can rotate the driving member 740 through the handle 710 to disengage the internal threads from the external threads, and then withdraw the driving member 740.

[0076] Based on the above embodiments, exemplarily, the operation method of the valve repair system 1000 proposed in this embodiment is as follows: The operator operates the handle 710 to move the sheath assembly and the valve clip 100 connected to the sheath 720 to the set position of the mitral valve through a minimally invasive body surface entrance and blood vessels according to the set steps. At this time, the clamping arms 20 are in a closed state, the locking strip 13 is in a curled state and is located outside the locking buckle 12. First, use the handle 710 to push the driving member 740 to move the connected sliding member 30 toward the distal end, so that the clamping arms 20 connected to the sliding member 30 through the pivoting mechanism 40 are unfolded. After adjusting the position of the valve clip 100 to align it with the part of the mitral valve to be clamped, use the handle 710 to pull the driving member 740 to move the sliding member 30 toward the proximal end to close the clamping arms 20 to clamp the valve. Then, pull the pulling member 11 to make the locking strip 13 extend into the locking buckle 12 and cooperate with the locking buckle 12. At this time, the sliding member 30 cannot move toward the distal end, that is, locking is achieved. Finally, disengage the driving member 740 from the sliding member 30, disengage the connecting mechanism from the valve clip 100, withdraw the driving member 740 and the sheath assembly, and leave the valve clip 100 in the patient's body in a state of clamping the valve.

[0077] The above is only a preferred specific embodiment of the present invention, but the protection scope of the present invention is not limited thereto. Any changes or substitutions that can be easily thought of by those skilled in the art within the technical scope disclosed by the present invention should be covered by the protection scope of the present invention. Therefore, the protection scope of the present invention should be subject to the protection scope of the claims.

Claims

1. A valve clip, characterized in that, Comprising: A plurality of clamping arms; At least one sliding member, which is connected to the clamping arms through a pivoting mechanism, so that the clamping arms are rotationally unfolded or rotationally closed according to the axial sliding of the sliding member; A locking mechanism, the locking mechanism includes a pulling member, a locking buckle and a locking bar, the locking buckle includes a housing and at least one rolling body, a conical channel is arranged in the housing, the rolling body is axially movably arranged in the conical channel, the first end of the locking bar is connected to the sliding member or the pivoting mechanism, the second end of the locking bar is connected to the pulling member, the pulling member is used to drive the locking bar to extend into the locking buckle to cooperate with the locking buckle, in the working condition where the locking bar cooperates with the locking buckle, the rolling body is in rolling contact with the inner wall of the conical channel and the locking bar to prevent the clamping arms from rotating and unfolding.

2. The valve clip according to claim 1, characterized in that, The rolling body is arranged as a sphere or a cylinder.

3. The valve clip according to claim 1, characterized in that, First openings and second openings communicating with the conical channel are respectively arranged at both axial ends of the housing, the area of the first opening is smaller than the area of the second opening, and the locking bar is arranged to extend into the conical channel from the first opening and extend out from the second opening.

4. The valve clip according to claim 3, wherein The cross-sectional area of the conical channel gradually decreases in the direction from the proximal end to the distal end, and / or the conical channel includes a planar side wall and a conical side wall, and the planar side wall and the conical side wall enclose a conical space.

5. The valve clip according to any one of claims 1 to 4, characterized in that, The valve clip applier further includes a central shaft cylinder, the plurality of clamping arms are wound around the periphery of the central shaft cylinder, the sliding member is slidably arranged in the central shaft cylinder, and the locking buckle is connected to the central shaft cylinder.

6. The valve clip according to claim 5, wherein The pivoting mechanism includes a base and a linkage arm, the linkage arm is respectively rotatably connected to the base and the clamping arms, the base is fixedly connected to the sliding member, the first end of the locking bar is connected to the base, and the second end of the locking bar can move towards the proximal end and extend into the locking buckle.

7. The valve clip applicator according to claim 6, characterized in that, At least part of the locking bar is in a bent state, and the locking bar generates elastic deformation according to the pulling of the pulling member.

8. The valve clip according to claim 1, wherein The pulling member is arranged as a metal wire or a non-metal wire.

9. A valve repair system, characterized in that, The valve repair system includes: A valve clip applier, the valve clip applier is the valve clip applier according to any one of claims 1 to 8; A delivery device, the delivery device is detachably connected to the valve clip applier to deliver the valve clip applier to a set position, the delivery device includes at least one driving member, and the driving member is connected to the sliding member of the valve clip applier to drive the sliding member to slide.

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