Heart valve clip

Abstract

The present invention provides a heart valve clamp, comprising a fixed arm mechanism, a clamping arm mechanism and a driving mechanism, wherein the fixed arm mechanism comprises a fixed arm body and at least two fixed arms extending outward from the fixed arm body, wherein the fixed arm and the fixed arm body are integrally formed; the clamping arm mechanism comprises a clamping arm body connected to the bottom of the fixed arm body and at least two clamping arms extending outward from the clamping arm body, wherein the clamping arm and the clamping arm body are integrally formed; and the driving mechanism comprises a second driving component for driving the fixed arm and the clamping arm to open or close. The fixed arm mechanism and the clamping arm mechanism of the whole heart valve clamp are respectively an integral whole, which can avoid the risk of the fixed arm or the clamping arm being disengaged, and the stability of the whole structure is better. Under three-dimensional ultrasound and angiography navigation, the fixed arm and the clamping arm clamp the valve leaflet, thereby reducing the regurgitation area, and can achieve the treatment of mitral valve regurgitation or tricuspid valve regurgitation without stopping the heart beating.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a heart valve clip. Background Art

[0002] The mitral valve is a one-way valve located between the left atrium and the left ventricle of the heart. A normal and healthy mitral valve can control the blood flow from the left atrium to the left ventricle, while preventing the blood from flowing from the left ventricle to the left atrium. With the development of society and the aging of the population, the incidence of mitral regurgitation (MR) has shown a significant upward trend and has become a common heart valve disease.

[0003] At present, the treatment of mitral regurgitation has gone through the era of traditional surgical median sternotomy and recent minimally invasive small incision surgery, and is ushering in the era of transcatheter interventional treatment. Minimally invasive treatment technology for mitral regurgitation has become one of the most popular research directions in interventional cardiology, and great progress has been made in the MR method of interventional treatment with less trauma, fewer complications and less cost.

[0004] In mitral regurgitation, interventional treatment techniques for mitral regurgitation can be divided into two categories: one is transcatheter mitral valve repair, such as MitraClip, PASCAL, ValveClam, Cardioband, Mitralign and NeoChord, and the other is transcatheter mitral valve implantation, which currently uses repair as the main treatment method. However, there are still some problems with the current technology. For example, MitralClip clamps the anterior and posterior leaflets of the mitral valve to change the large single hole into a small double hole to achieve the purpose of treatment, but the implantation path is too far and the operation is too complicated, and it needs to be improved.

[0005] There is a valve clamp and a valve clamp system in the prior art, and the valve clamp system includes a valve clamp and a pushing device. The valve clamp includes a push rod, at least two clamps, at least one extension arm, and a driving assembly for driving the clamps to open and close and the extension arm to extend and retract. Each clamp includes a first clamp arm and a second clamp arm that can be opened and closed relative to each other, and at least one extension arm is telescopically arranged on the surface of the first clamp arm. During surgery, the first clamp arm and the second clamp arm can be opened and closed, and the valve leaflet located between the first clamp arm and the second clamp arm can be clamped.

[0006] However, in the above-mentioned valve clamp, the number of the first clamp arm and the second clamp arm is 2 or more, and each first clamp arm or second clamp arm is separately provided, that is, during production and processing, each clamp arm is assembled and connected with the middle push rod or drive assembly, and its integrity is weak, there may be a risk of partial detachment, and the connection is not stable enough. Summary of the invention

[0007] The object of the present invention is to provide a heart valve clamp to solve the technical problem in the prior art that the clamp arms are separately provided and thus the connection is not stable enough and there is a risk of disengagement.

[0008] To achieve the above-mentioned purpose, the technical solution adopted by the present invention is: to provide a heart valve clamp, including: a fixed arm mechanism, a clamping arm mechanism and a driving mechanism, the fixed arm mechanism includes a fixed arm body and at least two fixed arms extending outward from the fixed arm body, and the fixed arm is integrally formed with the fixed arm body; the clamping arm mechanism includes a clamping arm body connected to the bottom of the fixed arm body and at least two clamping arms extending outward from the clamping arm body, and the clamping arm is integrally formed with the clamping arm body; the driving mechanism includes a first driving component for driving the fixed arm to open or close relative to the fixed arm body and a second driving component for driving the clamping arm to open or close relative to the clamping arm body.

[0009] Furthermore, the main body of the fixed arm is a tubular structure, and a first strip-shaped groove is provided on the side wall of the tubular structure, and the tubular wall located in the first strip-shaped groove is the fixed arm.

[0010] Furthermore, it also includes a delivery sheath fixed to the top of the fixed arm body.

[0011] Furthermore, the fixed arm mechanism also includes a sheath hanging head located at the top of the fixed arm body, and the sheath hanging head is detachably fixedly connected to the delivery sheath.

[0012] Furthermore, the sheath tube hanging head is at least one "T"-shaped hook protruding from the top of the fixed arm body, and the bottom of the delivery sheath is provided with a fixing groove for accommodating the sheath tube hanging head, and the fixing groove is engaged with the sheath tube hanging head and can be bent to disengage.

[0013] Furthermore, the fixed arm is pre-shaped to open in a direction away from the fixed arm body, and the first driving assembly includes at least two pulling wires, and the end of each pulling wire is fixedly connected to one of the fixed arms and drives a single or multiple fixed arms to open or close.

[0014] Furthermore, the fixing arm is provided with a fixing hole for fixing the pulling wire at one end away from the fixing arm body.

[0015] Furthermore, a barb structure is provided on a side of the fixing arm facing the clamping arm.

[0016] Furthermore, the clamping arm mechanism also includes a pulling arm base and at least two pulling arms extending outward from the pulling arm base, the pulling arm base is located at the bottom of the clamping arm body, and the pulling arm is fixedly connected to the clamping arm or is integrally formed, and the connection point between the pulling arm and the clamping arm is spaced apart from the clamping arm body.

[0017] Furthermore, the pulling arm base is a tubular structure, and a second strip groove is provided on the side wall of the tubular structure, the tube wall located inside the second strip groove is the pulling arm, and a third strip groove is provided on the tube wall outside the second strip groove, and the tube wall inside the third strip groove forms the clamping arm and the clamping arm body.

[0018] Furthermore, the second driving assembly includes a pushing rod, and the pushing rod is slidably disposed in the fixed arm body and the clamping arm body and abuts against the pulling arm base.

[0019] Furthermore, the clamping arm is pre-shaped to fit on the clamping arm body, and the pushing rod can drive the pulling arm base to move toward a side away from the clamping arm body and drive the clamping arm to open.

[0020] Furthermore, the number of the fixed arms and the number of the clamping arms are both two, the two fixed arms are symmetrical, the two clamping arms are symmetrical, and the fixed arms are directly opposite to the clamping arms.

[0021] Furthermore, the maximum opening angle of the fixed arm is greater than or equal to the maximum opening angle of the clamping arm.

[0022] Furthermore, the fixed arm mechanism and the clamping arm mechanism are both made of shape memory alloy.

[0023] Furthermore, outer edges of the fixing arm and the clamping arm are both provided with rounded corners or chamfers.

[0024] Furthermore, outer sides of the fixed arm mechanism and the clamping arm mechanism are both covered with fiber sewing cloth.

[0025] The beneficial effects of the heart valve clamp provided by the present invention are as follows: compared with the prior art, the heart valve clamp of the present invention, the fixing arm mechanism and the clamping arm mechanism of the entire heart valve clamp are respectively an integral whole, and the fixing arm mechanism and the clamping arm mechanism are fixedly connected, which can avoid the risk of the fixing arm or the clamping arm being detached, and the stability of the entire structure is better, and it is driven to open or close separately by the first drive component and the second drive component. Under three-dimensional ultrasound and angiography navigation, the fixing arm and the clamping arm clamp the valve leaflet, thereby reducing the regurgitation area, realizing transcatheter edge-to-edge repair, and being able to achieve treatment of mitral valve regurgitation or tricuspid valve regurgitation without stopping the heart beating, and the structure is simpler and the production is more convenient. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0027] Figure 1 A schematic diagram of the structure of the heart valve clip provided by an embodiment of the present invention when it is folded;

[0028] Figure 2 A schematic diagram of the structure of the heart valve clip provided by an embodiment of the present invention when it is opened;

[0029] Figure 3 It is a schematic side view of the structure of the fixed arm mechanism used in the embodiment of the present invention when it is folded;

[0030] Figure 4 It is a structural schematic diagram of the fixed arm mechanism used in the embodiment of the present invention when it is opened;

[0031] Figure 5 It is a structural schematic diagram of the fixed arm mechanism used in the embodiment of the present invention when it is deployed;

[0032] Figure 6 It is a schematic side view of the structure of the clamping arm mechanism used in the embodiment of the present invention when it is folded;

[0033] Figure 7 Another side view of the structure of the clamping arm mechanism used in the embodiment of the present invention when it is folded;

[0034] Figure 8 This is a schematic structural diagram of the clamping arm mechanism used in an embodiment of the present invention when it is opened;

[0035] Fig. 9It is a schematic structural diagram of the clamping arm mechanism used in an embodiment of the present invention when it is unfolded;

[0036] Fig.10 A schematic diagram of the structure of the heart valve clip provided by an embodiment of the present invention during insertion;

[0037] Fig.11 A schematic diagram of the structure of the heart valve clamp provided by an embodiment of the present invention when the clamping arms are opened;

[0038] Fig.12 A schematic diagram of the structure of the heart valve clip provided by an embodiment of the present invention when the bilateral fixing arms are opened;

[0039] Fig.13 A schematic diagram of the structure of a heart valve clip provided by an embodiment of the present invention when a single-side fixing arm is opened;

[0040] Fig.14 This is a schematic structural diagram of the heart valve clip provided by an embodiment of the present invention when fixation is completed.

[0041] Description of reference numerals:

[0042] 100, fixed arm mechanism; 200, clamping arm mechanism; 300, pushing rod; 400, delivery sheath; 500, pulling wire; 600, leaflet; 110, fixed arm body; 120, fixed arm; 130, first strip groove; 140, sheath hanging head; 121, fixing hole; 122, barb structure; 210, clamping arm body; 220, clamping arm; 230, pulling arm base; 240, pulling arm; 250, second strip groove; 260, third strip groove; 410, fixing groove. DETAILED DESCRIPTION

[0043] The technical solution of the present invention will be described clearly and completely below in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0044] In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, 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. In addition, the terms "first", "second", and "third" are used for descriptive purposes only, and cannot be understood as indicating or implying relative importance.

[0045] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0046] In addition, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0047] Please also read Figure 1 and Figure 2 The heart valve clamp provided by the present invention is now described. The heart valve clamp comprises a delivery sheath 400, a fixed arm mechanism 100 fixed to the bottom of the delivery sheath 400, a clamping arm mechanism 200 sleeved on the bottom of the fixed arm body 110, and a driving mechanism for driving the clamping arm 220 and the fixed arm 120 to open and close. The fixed arm mechanism 100 comprises a fixed arm body 110 fixedly connected to the bottom of the delivery sheath 400 and at least two fixed arms 120 extending outward from the fixed arm body 110, and the fixed ends of the fixed arms 120 are both connected to the fixed arm body 110. The fixed arm body 110 is integrally formed; the clamping arm mechanism 200 includes a clamping arm body 210 mounted on the bottom of the fixed arm body 110 and at least two clamping arms 220 extending outward from the clamping arm body 210, and the fixed ends of the clamping arms 220 are integrally formed with the clamping arm body 210; the driving mechanism includes a first driving component that drives the fixed arm 120 to open or close toward the clamping arm 220 and a second driving component that drives the clamping arm 220 to open or close toward the fixed arm 120.

[0048] Compared with the prior art, the heart valve clamp provided by the present invention has a whole heart valve clamp that can be driven by the delivery sheath 400 to enter the left atrium, and the fixed arm mechanism 100 and the clamping arm mechanism 200 are respectively an integral whole, and the fixed arm mechanism 100 and the clamping arm mechanism 200 are fixedly connected, which can avoid the risk of the fixed arm 120 or the clamping arm 220 being detached, and the stability of the whole structure is better, and it is driven to open or close by the first drive component and the second drive component separately, and under the guidance of three-dimensional ultrasound and angiography, the fixed arm 120 and the clamping arm 220 clamp the valve leaflet 600, thereby reducing the regurgitation area and realizing transcatheter edge-to-edge repair, which can realize the treatment of mitral valve regurgitation or tricuspid valve regurgitation without stopping the heart beating, and the structure is simpler and the production is more convenient.

[0049] For further information, please also refer to Figures 3 to 5 As a specific embodiment of the heart valve clamp provided by the present invention, the fixed arm body 110 is a tubular structure, and a first strip groove 130 is provided on the side wall of the tubular structure, and the tubular wall located in the first strip groove 130 is the fixed arm 120. Specifically, the first strip groove 130 is a groove provided on the tubular structure, and the groove is long and can be enclosed in the shape of the fixed arm 120, so that the top end of the fixed arm 120 is separated from the fixed arm body 110, and the bottom end of the fixed arm 120 is still connected to the fixed arm body 110, that is, the fixed arm 120 has a fixed end fixedly connected to the fixed arm body 110, and a free end that can be rotated and opened around the fixed arm body 110. The entire fixed arm mechanism 100 is formed in one piece from a tubular structure, and its integrity is better and the production, processing and assembly are more convenient, which greatly saves the assembly process. Of course, according to actual conditions and specific needs, in other embodiments of the present invention, only the fixed arm body 110 may be a tubular structure, and the fixed arm 120 may be an extension component provided at the top of the tubular structure, and this is not the only limitation.

[0050] For further information, see Figures 1 to 5 As a specific embodiment of the heart valve clamp provided by the present invention, the fixed arm mechanism 100 also includes a sheath hanging head 140 located at the top of the fixed arm body 110, and the sheath hanging head 140 is detachably fixedly connected to the delivery sheath 400. Specifically, the sheath hanger 140 is used to connect with the delivery sheath 400, wherein the delivery sheath 400 is a type of introductory catheter that can be inserted into the interior of the left ventricle. The sheath hanger 140 is arranged at the top of the fixed arm mechanism 100, and the sheath hanger 140 can realize a detachable connection between the entire fixed arm mechanism 100 and the delivery sheath 400, and then realize a fixed connection between the clamping arm mechanism 200 and the delivery sheath 400, ensuring that the fixed arm mechanism 100 and the clamping arm mechanism 200 can move together with the delivery sheath 400, and after the fixed arm 120 and the clamping arm 220 respectively clamp the leaflet 600, the fixed arm mechanism 100 and the delivery sheath 400 can be removed, and only the fixed arm mechanism 100 and the clamping arm mechanism 200 are retained in the ventricle.

[0051] Further, see Figures 1 to 5As a specific embodiment of the heart valve clip provided by the present invention, the sheath tube hanging head 140 is at least one "T"-shaped hook protruding from the top of the fixed arm body 110, and the bottom of the delivery sheath tube 400 is provided with a fixing groove 410 for accommodating the sheath tube hanging head 140. Specifically, the sheath tube hanging head 140 is a "T"-shaped hook, and the fixing groove 410 is a "T"-shaped groove. The "T"-shaped hook can be placed in the "T"-shaped groove, so as to realize the connection between the sheath tube hanging head 140 and the delivery sheath tube 400, and at this time, the push rod 300 can be inserted into the inside of the delivery sheath tube 400 and the sheath tube hanging head 140, and the push rod 300 can limit the relative bending between the delivery sheath tube 400 and the sheath tube hanging head 140, that is, the sheath tube hanging head 140 can always be engaged in the inside of the fixing groove 410. When the work is completed, the push rod 300 can be pulled out of the delivery sheath 400. At this time, the delivery sheath 400 and the sheath head 140 can be bent relative to each other. The delivery sheath 400 is moved to make the sheath head 140 bend, so that the sheath head 140 can be disengaged from the fixed groove 410, thereby realizing the separation between the delivery sheath 400 and the sheath head 140. The separation method is simple and can be achieved by cooperating with the push rod 300 to achieve separation, which can effectively avoid misoperation, thereby realizing the separation between the delivery sheath 400 and the sheath head 140, and the operation is convenient, shortening the operation time, reducing the difficulty and risk of the operation. Of course, according to actual conditions and specific needs, in other embodiments of the present invention, threads can also be formed on the outer side of the sheath head 140 and the inner side of the delivery sheath 400, and then the detachable connection between the delivery sheath 400 and the sheath head 140 is realized by threaded connection, which is not the only limitation here.

[0052] Preferably, the outer diameter of the push rod 300 matches the inner wall of the delivery sheath 400 and the fixed arm body 110, so that the push rod 300 can slide in the delivery sheath 400 and the fixed arm body 110, and completely fill the interior of the delivery sheath 400 and the fixed arm body 110, that is, the outer diameter of the push rod 300 is less than or equal to the inner diameter of the delivery sheath 400, and the outer diameter of the push rod 300 is less than or equal to the inner diameter of the fixed arm body 110.

[0053] For further information, see Figures 1 to 5As a specific embodiment of the heart valve clamp provided by the present invention, the fixed arm 120 is pre-shaped to open toward the side away from the fixed arm body 110, and the first driving assembly includes at least two pulling wires 500, and the ends of the pulling wires 500 are fixedly connected to the free ends of the fixed arm 120. Specifically, the fixed arm 120 needs to be opened toward the side away from the fixed arm body 110 when in use, and needs to be folded on both sides of the fixed arm body 110 when in transportation. The fixed arm 120 is pre-shaped at a certain angle, and the angle needs to be greater than the maximum opening angle of the clamping arm 220, so that the fixed arm 120 can cooperate with the clamping arm 220 to clamp the leaflet 600 when it is naturally opened, and it can ensure that the leaflet 600 can still be normally fixed when the clamping arm 220 is expanded to the maximum angle. When in the delivery sheath, the left and right fixed arms 120 remain in a closed state under the tightening action of the pull wire 500. After reaching the specified position, the fixed arm 120 is expanded to a certain angle by loosening the pull wire 500, thereby realizing the expansion of the fixed arm 120. Among them, the predetermined expansion angle of the fixed arm 120 is generally 120° to 240°, and the rod width, structure and wall thickness of the fixed arm 120 determine the force value of the fixed leaflet 600 after the fixed arm 120 is expanded, which can be adjusted according to different lesions.

[0054] The driving structure of the opening or closing of the fixed arm 120 is realized by using a pulling wire 500, so that each fixed arm 120 can be individually unfolded, and can realize unilateral adjustment and full retractable functions to meet a variety of different surgical needs, and has a simple structure and is easy to operate.

[0055] For further information, see Figure 5As a specific embodiment of the heart valve clip provided by the present invention, the fixing arm 120 is provided with a fixing hole 121 for fixing the pull wire 500 at one end away from the fixing arm body 110. Specifically, the fixing hole 121 is provided at the free end of the fixing arm 120, and one end or the middle part of the pull wire 500 can pass through the fixing hole 121, thereby achieving connection between the pull wire 500 and the fixing hole 121. Among them, the end of the pull wire 500 can be directly tied to or fixed inside the fixing hole 121. At this time, the other end of the pull wire 500 passes through the inside of the delivery sheath 400 and extends to the outside of the body. The doctor can pull the other end of the pull wire 500 to control the fixed arm 120. After the operation is completed, the pull wire 500 can be cut off with scissors, or an easily soluble pull wire 500 can be used; the middle part of the pull wire 500 can also pass through the inside of the fixing hole 121, and both ends of the pull wire 500 pass through the inside of the delivery sheath 400 and extend to the outside of the body. The doctor can pull both ends of the pull wire 500 at the same time to control the fixed arm 120. After the operation is completed, the doctor pulls one end of the pull wire 500, and the other end can pass through the delivery sheath 400 and loosen from the fixing hole 121, thereby realizing the removal of the pull wire 500. The operation is simpler, the operation time is shorter, and the risk of surgery is lower.

[0056] Further, see Figures 3 to 5 As a specific embodiment of the heart valve clamp provided by the present invention, a barb structure 122 is provided on one side of the fixed arm 120 facing the clamping arm 220. Specifically, the barb structure 122 is a plurality of protrusions arranged on the bottom surface of the fixed arm 120. When the fixed arm 120 is in a retracted state, the tip of the protrusion is tilted downward, that is, tilted toward the clamping arm 220; when the fixed arm 120 is in an open state, the tip of the protrusion is also tilted downward, which can play a role in increasing the friction of the fixed leaflet 600. Among them, the number of protrusions can be adjusted according to actual conditions, and can be one or more.

[0057] For further information, see Figure 2 , Figures 6 to 9As a specific embodiment of the heart valve clamp provided by the present invention, the clamping arm mechanism 200 further includes a pulling arm base 230 and at least two pulling arms 240 extending outward from the pulling arm base 230, the pulling arm base 230 is located at the bottom of the clamping arm body 210, and the pulling arm 240 is fixedly connected or integrally formed with the bottom of the free end of the clamping arm 220. Specifically, the pulling arm base 230 is located at the bottom of the clamping arm body 210, the pulling arm 240 is formed by the pulling arm base 230 extending upward, and the pulling arm 240 is connected to the pulling arm base 230, and the pulling arm 240 can also be opened or retracted around the pulling arm base 230, so that the opening and retraction of the clamping arm 220 are driven by the pulling arm 240, and the opening and retraction of the clamping arm 220 are controlled by the position of the pulling arm base 230. Among them, the pulling arm base 230, the pulling arm 240, the clamping arm 220 and the clamping arm body 210 can all be integrally formed; or the clamping arm 220 and the clamping arm body 210 can be integrally formed, the pulling arm base 230 and the pulling arm 240 can be integrally formed, and the clamping arm 220 and the pulling arm 240 are fixedly connected, which is not the only limitation here.

[0058] For further information, see Fig. 9As a specific embodiment of the heart valve clamp provided by the present invention, the pulling arm base 230 is a tubular structure, and a second strip groove 250 is provided on the side wall of the tubular structure, the tubular wall located inside the second strip groove 250 is the pulling arm 240, and a third strip groove 260 is provided on the tubular wall outside the second strip groove 250, and the tubular wall inside the third strip groove 260 forms the clamping arm 220 and the clamping arm body 210. Specifically, the second strip groove 250 is a groove provided on the tubular structure, and the groove is long and can be enclosed in the shape of the pulling arm 240, so that the top end of the pulling arm 240 and the pulling arm base 230 are separated, and the bottom end of the pulling arm 240 is still connected to the pulling arm base 230, that is, the pulling arm 240 also has a fixed end fixedly connected to the pulling arm base 230, and a free end that can rotate around the pulling arm base 230 and open. A third strip groove 260 is then provided on the remaining tube wall. The groove is long and can be enclosed in the shape of the clamping arm 220 and the clamping body, so that the top of the pulling arm 240 is connected to the top of the clamping arm 220, the bottom of the clamping arm 220 is fixedly connected to the clamping arm body 210, and the outer edge of the clamping arm body 210 is separated from the pulling arm 240 and the pulling arm base 230. At this time, the entire clamping arm mechanism 200 is integrally formed by a tube structure, which has better integrity and is more convenient for production, processing and assembly, greatly saving the assembly process. Of course, according to actual conditions and specific needs, in other embodiments of the present invention, the clamping arm body 210 can also be a tube structure, and the clamping arm 220 is an extension component provided at the top of the tube structure; the pulling arm base 230 is a tube structure, and the pulling arm 240 is an extension component provided at the top of the tube structure, and the pulling arm 240 and the clamping arm 220 are fixedly connected, which is not limited to this.

[0059] For further information, see Figure 2As a specific embodiment of the heart valve clamp provided by the present invention, the second driving assembly includes a push rod 300 disposed in the delivery sheath 400, and the push rod 300 is slidably disposed in the fixed arm body 110 and the clamping arm body 210 and abuts against the pulling arm base 230. Specifically, the push rod 300 is disposed in the delivery sheath 400, and can abut against or be detachably connected to the pulling arm base 230, and the push rod 300 drives the movement of the pulling arm base 230, so that the push rod 300, the pulling arm 240 and the clamping arm 220 can form a connecting rod mechanism, and then the movement of the push rod 300 drives the opening and closing of the pulling arm 240 and the clamping arm 220. The push rod 300 can move in the fixed arm mechanism 100 and the clamping arm mechanism 200. When the push rod 300 moves toward the distal end, it pushes the pulling arm base 230 to move, thereby driving the pulling arm 240 to expand to a certain angle γ, and finally the clamping arm 220 expands to a corresponding angle β, about 0°-210°. The expansion angle β can be adjusted in real time through the relative position of the pulling arm 240, and the angle β is greater than the angle γ. The clamping force of the clamping arm 220 can be adjusted through the rod width of the clamping arm 220 and the pulling arm 240, the wall thickness of the pipe and the structure.

[0060] Furthermore, as a specific embodiment of the heart valve clamp provided by the present invention, the clamping arm 220 is pre-shaped to fit on the clamping arm body 210, and the pushing rod 300 can drive the pulling arm base 230 to move toward the side away from the clamping arm body 210 and drive the clamping arm 220 to open. Specifically, the clamping arm 220 needs to be moved toward the side close to the clamping arm body 210 when in use. When in the transportation state, the clamping arm 220 is naturally folded on both sides of the clamping arm body 210. When it is necessary to clamp the leaflet 600, the pulling arm 240 is used to stretch the clamping arm 220 so that the clamping arm 220 is located on the inner side of the leaflet 600. After the fixing arm 120 is also fixed, the pulling arm 240 does not have the pulling force to stretch the clamping arm 220 after the pushing rod 300 is removed. The clamping arm 220 has a large restoring force to move toward the clamping arm body 210, and the fixing arm 120 also has a restoring force away from the fixing arm body 110. At this time, the clamping force between the clamping arm 220 and the fixing arm 120 can be better guaranteed, thereby ensuring the clamping effect on the leaflet 600.

[0061] For further information, see Figure 2 , Figures 6 to 9As a specific embodiment of the heart valve clip provided by the present invention, the number of the fixed arm 120 and the clamping arm 220 are both two, the two fixed arms 120 are symmetrical, the two clamping arms 220 are symmetrical, and the fixed arm 120 and the clamping arm 220 are opposite. When the number of the fixed arm 120 and the clamping arm 220 are both two, it can be applied to the treatment of mitral regurgitation. The fixed arm 120 and the clamping arm 220 are both symmetrically arranged, which can ensure the uniformity of the force applied by the entire heart valve clip to the leaflet 600. The fixed arm 120 and the clamping arm 220 are opposite to each other, which can also ensure accurate clamping of the leaflet 600. Of course, according to actual conditions and specific needs, in other embodiments of the present invention, the setting of the fixed arm 120 and the clamping arm 220 can also be asymmetrical, and the number of the fixed arm 120 and the clamping arm 220 can also be three or more, which can be applied to the treatment of tricuspid regurgitation or multiple tricuspid regurgitation, which is not limited here.

[0062] Further, as a specific embodiment of the heart valve clamp provided by the present invention, the fixed arm mechanism 100 and the clamping arm mechanism 200 are both made of shape memory alloy. Specifically, shape memory alloy refers to a metal that can keep memory of the initial shape, that is, the fixed arm 120 is pre-shaped to open toward the side away from the fixed arm body 110, and the clamping arm 220 is pre-shaped to fit on the clamping arm body 210, which can ensure that there is a good return effect between the clamping arm 220 and the fixed arm 120, and then ensure the clamping force between the clamping arm 220 and the fixed arm 120. Among them, the shape memory alloy is generally made of NiTi alloy or the like.

[0063] Further, as a specific embodiment of the heart valve clamp provided by the present invention, the outer edges of the fixed arm 120 and the clamping arm 220 are provided with rounded corners or chamfers. Specifically, the outer edges of the fixed arm 120, the clamping arm 220 and the pulling arm 240 may come into contact with the heart, and chamfers are provided on the edges of the fixed arm 120, the clamping arm 220 and the pulling arm 240, and the corners are rounded, which can make the outer edge of the entire heart valve clamp smoother and effectively reduce the degree of trauma. Among them, the rounded corners or chamfers can be obtained by a polishing process during production.

[0064] Furthermore, as a specific embodiment of the heart valve clip provided by the present invention, the outer sides of the delivery sheath 400, the fixing arm mechanism 100 and the clamping arm mechanism 200 are all covered with fiber sewing cloth (not shown). Specifically, the fiber sewing cloth is provided on the parts of the heart valve clip that may contact the human body, and the fiber sewing cloth can provide endothelial tissue for climbing, reduce damage to organ tissues during surgery, and more tightly complete the clamping of the valve.

[0065] For the heart valve clip provided by the present invention, please refer to Figures 10 to 14 , taking the treatment of mitral regurgitation as an example for detailed explanation, the surgical route is transcatheter, and the delivery sheath 400 is delivered to the left atrium, and subsequent operations are based on this.

[0066] First, after placing the heart valve clipper at the left atrium position through the delivery sheath 400, the heart valve clipper is pushed to the lower part of the valve, and the pulling arm base 230 is pushed by the pushing rod 300. Then, after the clamping arm 220 is unfolded to a certain angle through the pulling arm 240, the heart valve clipper is pulled upward so that the clamping arm 220 holds the valve leaf 600 from the bottom, and then the pulling line 500 is released to unfold the fixed arm 120 and firmly press the valve leaf 600 on the clamping arm 220. After determining that the clamping position of the valve leaf 600 is appropriate and the reflux treatment effect is achieved, the pushing rod 300 is withdrawn for a certain distance to complete the closing step of the heart valve clipper, and the clamping effect is determined again. If the reflux is reduced to an acceptable level, the pushing rod 300 can be further withdrawn to the proximal end of the sheath hanging head 140 to complete the releasing step of the heart valve clipper. If necessary, the above steps can be repeated until the ideal effect is achieved.

[0067] The pull wire 500 of the clip is connected to the two fixed arms 120 respectively, and the expansion angle of a single fixed arm 120 can be controlled by adjustment. When the push rod 300 has not been withdrawn to the position of the sheath tube hanging head 140, the heart valve clip can be opened to release the fixed leaflet 600, and the above implantation steps can be repeated, so as to achieve a completely recyclable operation, thereby greatly reducing the risk of implantation.

[0068] Obviously, the above embodiments are merely examples for the purpose of clear explanation, and are not intended to limit the implementation methods. For those skilled in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all the implementation methods here. The obvious changes or modifications derived therefrom are still within the scope of protection of the invention.

Claims

1. A heart valve clip, characterized in that: include A fixed arm mechanism (100), the fixed arm mechanism (100) comprising a fixed arm body (110) and at least two fixed arms (120) extending outward from the fixed arm body (110), the fixed arms (120) being integrally formed with the fixed arm body (110); A clamping arm mechanism (200), the clamping arm mechanism (200) comprising a clamping arm body (210) connected to the bottom of the fixed arm body (110) and at least two clamping arms (220) extending outward from the clamping arm body (210), the clamping arms (220) being integrally formed with the clamping arm body (210); as well as a driving mechanism, the driving mechanism comprising a first driving component for driving the fixed arm (120) to open or close relative to the fixed arm body (110) and a second driving component for driving the clamping arm (220) to open or close relative to the clamping arm body (210); The fixed arm body (110) is a tubular structure, and a first strip-shaped groove (130) is provided on the side wall of the tubular structure, and the tubular wall located in the first strip-shaped groove (130) is the fixed arm (120); The fixed arm (120) is pre-shaped to open in a direction away from the fixed arm body (110), the first driving assembly comprises at least two pulling wires (500), the end of each pulling wire (500) is respectively fixedly connected to one of the fixed arms (120) and drives one or more of the fixed arms (120) to open or close; the fixed arm (120) is provided with a fixing hole (121) at one end away from the fixed arm body (110) for fixing the pulling wire (500); The clamping arm mechanism (200) further comprises a pulling arm base (230) and at least two pulling arms (240) extending outward from the pulling arm base (230), wherein the pulling arm base (230) is located at the bottom of the clamping arm body (210), and the pulling arm (240) is fixedly connected or integrally formed with the clamping arm (220), and the connection point between the pulling arm (240) and the clamping arm (220) is adjacent to the clamping arm body (210). The pulling arm base (230) is arranged at intervals; the pulling arm base (230) is a tubular structure, and a second strip groove (250) is provided on the side wall of the tubular structure, the tube wall located inside the second strip groove (250) is the pulling arm (240), and a third strip groove (260) is provided on the tube wall outside the second strip groove (250), and the inner tube wall of the third strip groove (260) forms the clamping arm (220) and the clamping arm body (210).

2. The heart valve clip according to claim 1, characterized in that: It also includes a delivery sheath tube (400) fixed to the top of the fixed arm body (110).

3. The heart valve clip according to claim 2, characterized in that: The fixed arm mechanism (100) further comprises a sheath tube hanging head (140) located at the top of the fixed arm body (110), and the sheath tube hanging head (140) is detachably fixedly connected to the delivery sheath tube (400).

4. The heart valve clip according to claim 3, characterized in that: The sheath tube hanging head (140) is at least one "T"-shaped hook protruding from the top of the fixed arm body (110); the bottom of the delivery sheath tube (400) is provided with a fixing groove (410) for accommodating the sheath tube hanging head (140); the fixing groove (410) is engaged with the sheath tube hanging head (140) and can be bent to disengage.

5. The heart valve clip according to any one of claims 1 to 4, characterized in that: A barb structure (122) is provided on a side of the fixing arm (120) facing the clamping arm (220).

6. The heart valve clip according to claim 1, characterized in that: The second driving assembly comprises a pushing rod (300), wherein the pushing rod (300) is slidably disposed in the fixed arm body (110) and the clamping arm body (210) and abuts against the pulling arm base (230).

7. The heart valve clip according to claim 6, characterized in that: The clamping arm (220) is pre-shaped to fit on the clamping arm body (210), and the pushing rod (300) can drive the pulling arm base (230) to move toward a side away from the clamping arm body (210) and drive the clamping arm (220) to open.

8. The heart valve clip according to claim 1, characterized in that: The number of the fixed arms (120) and the number of the clamping arms (220) are both two, the two fixed arms (120) are symmetrical, the two clamping arms (220) are symmetrical, and the fixed arms (120) and the clamping arms (220) are directly opposite to each other.

9. The heart valve clip according to claim 1, characterized in that: The maximum opening angle of the fixed arm (120) is greater than or equal to the maximum opening angle of the clamping arm (220).

10. The heart valve clip according to claim 1, characterized in that: The fixed arm mechanism (100) and the clamping arm mechanism (200) are both made of shape memory alloy.

11. The heart valve clip according to claim 1, characterized in that: The outer edges of the fixing arm (120) and the clamping arm (220) are both provided with rounded corners or chamfers.

12. The heart valve clip according to claim 1, characterized in that: The outer sides of the fixed arm mechanism (100) and the clamping arm mechanism (200) are both covered with fiber sewing cloth.

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