Edge-to-edge repair device and edge-to-edge repair system

Abstract

The present invention provides an edge-to-edge repair device, including a puncture piece for implanting on one leaflet and a fixing piece for implanting on the other leaflet, the puncture piece includes at least one puncture portion for puncturing the leaflet, the puncture portion punctures the leaflet on one side and the leaflet on the other side in sequence and then combines with the fixing piece, so that the leaflets on both sides are at least partially connected to the fixing piece through the puncture piece. The present invention also relates to an edge-to-edge repair system. The edge-to-edge repair device and system of the present invention can safely, effectively and quickly achieve edge-to-edge repair of the mitral valve.

Description

Technical Field

[0001] The present invention relates to the technical field of valve interventional repair, and in particular to an edge-to-edge repair device and an edge-to-edge repair system. 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 flow of blood from the left atrium to the left ventricle, while preventing blood from flowing from the left ventricle to the left atrium. The mitral valve consists of a pair of leaflets, called the anterior leaflet and the posterior leaflet. Under normal circumstances, when the left ventricle of the heart contracts, the edges of the anterior leaflet and the posterior leaflet are completely aligned to prevent blood from flowing from the left ventricle to the left atrium. When the leaflets of the mitral valve or its related structures undergo organic or functional changes, the anterior leaflet and the posterior leaflet of the mitral valve do not align well, and when the left ventricle of the heart contracts, blood flows back from the left ventricle to the left atrium, which is called "mitral regurgitation."

[0003] The edge-to-edge repair of the mitral valve is a common method for treating mitral regurgitation. Specifically, the edges of the anterior and posterior leaflets of the mitral valve that cannot be normally aligned are fixed together by suturing or clamping to form a double-hole structure, thereby narrowing the gap between the leaflets and eliminating or reducing the amount of regurgitation. Traditional mitral edge-to-edge repair is performed under open-surgery conditions, requiring thoracotomy and establishment of extracorporeal blood circulation, so it is relatively risky.

[0004] With the advancement of technology, various interventional devices and minimally invasive surgeries for treating mitral regurgitation have been developed. The prior art US20160113762A1 discloses an edge-to-edge repair device, which implants a magnetic sheet into the anterior leaflet and the posterior leaflet respectively by suturing, and the leaflets on both sides are attracted to each other by the magnetic sheets, thereby completing the edge-to-edge repair; however, this edge-to-edge repair device requires opening the heart for implantation under open-chest and cardiac arrest conditions, which causes greater harm to the patient; and this magnetic sheet is easily interfered by external magnetic metal and magnetic fields, thereby causing damage to the patient. The prior art US6269819B2 discloses an edge-to-edge repair device, which performs edge-to-edge repair by puncturing the anterior leaflet and the posterior leaflet in sequence with a straight piece with double puncture needles, then bending the straight piece, and locking the circular hole at the bottom with the puncture needle. However, it is difficult for this edge-to-edge repair device to capture the anterior leaflet and the posterior leaflet. In the absence of fixed leaflets, puncturing the leaflets can easily cause valve tearing. Moreover, the straight piece needs to be bent inside the ventricle and then cooperate with the puncture needle, which is difficult to achieve. Summary of the invention

[0005] The technical problem to be solved by the present invention is to provide a safer, more effective and faster edge-to-edge repair device and edge-to-edge repair system in view of the defects of the prior art.

[0006] In order to solve the above technical problems, the present invention provides an edge-to-edge repair device, including a puncture piece for implanting on one side of the leaflet and a fixing piece for implanting on the other side of the leaflet, the puncture piece includes at least one puncture portion for puncturing the leaflet, the puncture portion punctures the leaflet on one side and the leaflet on the other side in turn and then combines with the fixing piece, so that the leaflets on both sides are at least partially connected to the fixing piece through the puncture piece.

[0007] The present invention also provides an edge-to-edge repair system, including an edge-to-edge repair device and a conveying device, the conveying device including a push rod and a clamping assembly, the proximal end of the clamping assembly is connected to the push rod, the clamping assembly includes two clamping arms that can open and close relative to each other, the puncture member and the fixing member of the edge-to-edge repair device are pre-installed on the two clamping arms, respectively, the push rod moves axially toward the proximal end to drive the two clamping arms to close each other, so that the puncture portion of the puncture member punctures the valve leaflet and then combines with the fixing member.

[0008] The puncture piece and the fixing piece of the edge-to-edge repair device provided by the present invention are respectively pre-installed on the two clamping arms of the conveying device, and the push rod moves axially toward the proximal end to drive the two clamping arms to close each other, so that the puncture part on one clamping arm punctures the valve leaflet on one side and the valve leaflet on the other side in turn and then combines with the fixing piece on the other clamping arm, so that the valve leaflets on both sides are connected edge to edge at the combination between the puncture piece and the fixing piece. The edge-to-edge repair system is simple to operate and easy to use, and can safely, effectively and quickly complete the edge-to-edge repair of the mitral valve. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] In order to more clearly illustrate the technical solution of the embodiment of the present invention, the drawings required for use in the implementation are briefly introduced below.

[0010] Figure 1 It is a schematic diagram of the structure of an edge-to-edge repair system in one embodiment of the present invention.

[0011] Figure 2 yes Figure 1 Schematic diagram of an exploded view of the edge-to-edge repair device of the edge-to-edge repair system.

[0012] Figure 3 yes Figure 2 Schematic diagram of the three-dimensional structure of the edge-to-edge repair device.

[0013] Figure 4 yes Figure 3 Schematic diagram of the side structure of the piercing member.

[0014] Figure 5 yes Figure 3 Schematic diagram of the side view structure of the fixing part.

[0015] Figure 6 yes Figure 3 Schematic diagram of the structure after the piercing member and the fixing member are combined.

[0016] Figure 7 yes Figure 6 Cross-sectional view of a mid-edge-to-edge repair device.

[0017] Figure 8 yes Figure 2 A magnified view of the stabilizing component.

[0018] Fig. 9 yes Figure 8 Magnified view of the locating piece and locating arm of the center stabilizing assembly.

[0019] Fig.10 yes Figure 2 A schematic diagram of the three-dimensional structure of the clamping assembly of the conveying device.

[0020] Fig.11 yes Fig.10 A schematic three-dimensional structural diagram of the first clamping arm of the clamping assembly in FIG.

[0021] Fig.12 yes Fig.11 A cross-sectional view of the first clamping arm in FIG.

[0022] Fig.13 yes Fig.10 A schematic diagram of the three-dimensional structure of the second clamping arm of the clamping assembly.

[0023] Fig.14 Fig.13 A cross-sectional view of the second clamping arm in FIG.

[0024] Fig.15 yes Fig.10 A schematic diagram of the three-dimensional structure of the pushing member of the clamping assembly.

[0025] Fig.16 yes Fig.10 Schematic diagram of the three-dimensional structure of the fixed sleeve of the clamping assembly.

[0026] Fig.17 yes Fig.10 A schematic diagram of one of the states of the clamping assembly in FIG.

[0027] Figure 18-Figure 24 It is a schematic diagram of the use process of the edge-to-edge repair system provided by the present invention.

[0028] Fig.25 It is a schematic diagram of the three-dimensional structure decomposition of another embodiment of the edge-to-edge repair device of the present invention.

[0029] Fig.26 yes Fig.25Schematic diagram of the structure after the edge-to-edge repair device is combined.

[0030] Fig. 27 yes Fig.26 A cross-sectional view of an edge-to-edge repair device in FIG. DETAILED DESCRIPTION

[0031] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0032] In addition, the following descriptions of the embodiments are made with reference to the attached diagrams to illustrate specific embodiments in which the present invention may be implemented. The directional terms mentioned in the present invention, such as "upper", "lower", "front", "back", "left", "right", "inner", "outer", "side", etc., are only with reference to the directions of the attached diagrams. Therefore, the directional terms used are for better and clearer description and understanding of the present invention, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation, and therefore cannot be understood as limiting the present invention.

[0033] In order to more clearly describe the structure of the transcatheter suture implantation device and the transcatheter chord implantation system, the limiting terms "proximal end" and "distal end" described in the present invention are commonly used terms in the field of interventional medicine. Specifically, the "distal end" refers to the end away from the operator during the surgical operation, and the "proximal end" refers to the end close to the operator during the surgical operation. Unless otherwise defined, all technical and scientific terms used in the present invention have the same meaning as commonly understood by technicians in the technical field of the present invention. The common terms used in the specification of the present invention are only for the purpose of describing specific embodiments and are not to be construed as limitations on the present invention.

[0034] See also Figures 1 to 3The present invention provides an edge-to-edge repair system 100, including an edge-to-edge repair device 20 and a conveying device 40. The edge-to-edge repair device 20 includes a puncture piece 22 for implanting on one side of the leaflet and a fixing piece 24 for implanting on the other side of the leaflet. The puncture piece 22 includes at least one puncture portion 220 for puncturing the leaflet. The puncture portion 220 punctures the leaflet on one side and the leaflet on the other side in turn and then combines with the fixing piece 24, so that the leaflets on both sides are at least partially connected to the fixing piece 24 through the puncture piece 22. The conveying device 40 includes a pushing assembly 50 and a clamping assembly 70. The pushing assembly 50 includes a pushing rod 52. The proximal end of the clamping assembly 70 is connected to the pushing rod 52. The clamping assembly 70 includes two clamping arms that can be opened and closed relative to each other. The puncture member 22 and the fixing member 24 of the edge-to-edge repair device 20 are pre-installed on the two clamping arms, respectively. The pushing rod 52 moves axially toward the proximal end to drive the two clamping arms to close each other, so that the puncture portion 220 of the puncture member 22 punctures the valve leaflet and then combines with the fixing member 24.

[0035] The puncture member 22 and the fixing member 24 of the edge-to-edge repair device 20 provided by the present invention are respectively pre-installed on the two clamping arms of the conveying device 40, and the push rod 52 moves axially proximally to drive the two clamping arms to close each other, so that the puncture portion 220 on one clamping arm punctures the leaflets on one side and the leaflets on the other side in turn and then combines with the fixing member 24 on the other clamping arm, so that the leaflets on both sides are at least partially connected to the fixing member 24 through the puncture member 22, thereby realizing the "edge-to-edge" repair of the leaflets. The edge-to-edge repair system 100 is simple to operate, easy to use, and can complete edge-to-edge repair safely, effectively and quickly.

[0036] Please also read Figures 3 to 5 The puncture member 22 also includes a puncture base 222, and the puncture portion 220 is arranged on the side of the puncture base 222 facing the fixed member 24; the fixed member 24 includes a fixed base 241 and a receiving portion 243 arranged on the side of the fixed base 241 facing the puncture member 22, and the puncture portion 220 is connected to the receiving portion 243 after puncturing the leaflet. Specifically, the puncture portion 220 is at least one puncture needle fixedly connected to the puncture base 222, and the receiving portion 243 is a receiving sleeve fixedly connected to the fixed base 241 corresponding to the puncture needle, and the puncture needle can be fixedly inserted in the receiving sleeve. The number of puncture needles and receiving portions 243 can be set to two, three or several as needed, and the number of receiving portions 243 corresponds to the number of puncture needles. In this embodiment, two parallel and spaced puncture parts 220 (two puncture needles) are provided on the puncture base 222, and receiving parts 243 (two receiving sleeves) corresponding to the two puncture parts 220 are provided on the fixed base 241; the two puncture parts 220 are fixedly connected to the two receiving parts 243 after passing through the leaflets, which is conducive to reducing the difficulty of puncture, increasing the connection strength between the puncture member 22 and the fixing member 24, and dispersing the force points to prevent the leaflets from being torn.

[0037] like Figures 4 to 7 As shown, the puncture part 220 and the receiving part 243 are connected by interference fit, key connection, snap connection or threaded connection. Specifically, the puncture part 220 includes an extension rod 223 fixedly connected to the puncture base 222 and a needle 226 arranged at one end of the extension rod 223 away from the puncture base 222. The receiving part 243 is provided with a receiving cavity, and the needle 226 is inserted into the receiving cavity, so that the puncture part 220 and the receiving cavity are interference fit, key connection, elastic deformation connection, lock connection, snap connection or threaded connection. In this embodiment, the needle 226 at the distal end of the puncture part 220 is conical, and the shape of the receiving cavity matches the shape of the distal end of the puncture part 220, which is usually conical or cylindrical. Generally, the external overall shape of the receiving part 243 is cylindrical, and the cross-sectional shape parallel to the radial direction can be various shapes such as circular, elliptical, polygonal, etc., and generally circular and elliptical are preferred.

[0038] In other embodiments, the radial dimension of the proximal end of the needle 226 and / or the extension rod 223 is slightly larger than the radial dimension of the accommodating cavity of the receiving portion 243. When the needle 226 is inserted into the accommodating cavity, the needle 226 and the receiving portion 243 are tightly fitted and plugged into each other so that the two form a fixed connection with an interference fit.

[0039] In other embodiments, the puncture part 220 and the receiving part 243 can also be connected by snap-fit ​​connection, that is, a part or a whole circle is removed circumferentially at the proximal end of the needle 226 to form a convex tooth or flange; the side wall of the receiving cavity of the receiving part 243 is provided with a groove or hole corresponding to the convex tooth or flange, and after the puncture part 220 completes the puncture, the needle 226 is inserted into the receiving cavity, so that the convex tooth or flange of the needle 226 is inserted into the groove or hole of the receiving part 243 to achieve a fixed connection between the two. Preferably, the convex tooth or flange of the needle 226 and / or the groove or hole of the receiving part 243 have a certain elasticity, and elastic deformation occurs when the two are clamped together to ensure smooth connection and avoid release.

[0040] In other embodiments, an external thread is provided on the outer surface of the puncture portion 220, and an internal thread corresponding to the external thread of the puncture portion 220 is provided on the inner wall of the accommodating cavity of the receiving portion 243, and the external thread is threadedly connected with the internal thread.

[0041] In other embodiments, the puncture portion 220 and the receiving portion 243 may be connected by a key, a lock, or the like.

[0042] Preferably, the puncture portion 220 and the puncture base 222, the fixed base 241 and the receiving portion 243 are all made of metal materials such as stainless steel, nickel titanium, etc. The puncture portion 220 and the puncture base 222, the fixed base 241 and the receiving portion 243 can be integrally formed, or can be formed separately and then fixedly connected by welding, bonding, riveting, threaded connection, etc.

[0043] Preferably, in order to improve the friction between the puncture base 222 and the fixed base 241 and the corresponding leaflets, improve the biocompatibility of the puncture base 222 and the fixed base 241, and avoid tearing of the leaflets, the puncture base 222 is provided with a first anti-skid pad 225 on the side facing the leaflets, and / or the fixed base 24 is provided with a second anti-skid pad 245 on the side facing the leaflets, and the first anti-skid pad 225 and the second anti-skid pad 245 are both made of biocompatible polymer materials with a high friction coefficient. Specifically, the first anti-skid pad 225 and the second anti-skid pad 245 can be selected from at least one of an elastic pad, a heart patch, a felt sheet, a grid structure, a disc structure, or a double disc structure; preferably, a polyester cloth pad. The first anti-slip pad 225 can be fixedly connected to the puncture base 222 by bonding, sewing, etc.; if at least one through hole is provided on the puncture base 222, the suture thread passing through the first anti-slip pad 225 is passed through the through hole and sewn to the puncture base 222; the second anti-slip pad 245 can also be fixedly connected to the fixed base 241 by bonding, sewing, etc.; if at least one through hole is provided on the fixed base 241, the suture thread passing through the second anti-slip pad 245 is passed through the through hole and sewn to the fixed base 241.

[0044] A through hole 2250 is formed on the first anti-slip gasket 225 corresponding to the puncture part 220, and the end of the puncture part 220 away from the puncture base 222 passes through the corresponding through hole 2250 to expose the first anti-slip gasket 225; a through hole 2450 is formed on the second anti-slip gasket 245 corresponding to the receiving part 243, and the end of the receiving part 243 away from the fixed base 241 is inserted into the corresponding through hole 2450.

[0045] Preferably, if Fig.21 As shown, a puncture needle protective sleeve 227 is provided on the needle 226 of the puncture member 22, and the protective sleeve 227 is used to prevent the puncture member 22 and the fixing member 24 from being accidentally connected together during the transportation of the puncture portion 220, and to prevent the edge-to-edge repair device 20 from accidentally damaging the valve leaflet when it is in the open state.

[0046] Please also read Figure 1-Figure 2 and Figure 8-Figure 9The edge-to-edge repair system 100 also includes a stabilizing assembly 60, which includes an outer sheath 62 sleeved outside the push rod 52, a positioning member 64 disposed at the distal end of the outer sheath 62, and a positioning arm 66 movably mounted in the outer sheath 62. The positioning member 64 is used to support the valve leaflet, and the distal end of the positioning arm 66 extends out of the outer sheath 62. The positioning member 64 is disposed at the distal end of the positioning arm 66. The positioning member 64 extends out of the outer sheath 62 as the positioning arm 66 moves axially and extends obliquely toward the axis away from the outer sheath 62. The angle between the axial direction of the positioning member 64 and the axial direction of the positioning arm 66 ranges from 120 degrees to 150 degrees, so as to adapt to the anatomical structure of the valve leaflet and provide support force at the same time. In this embodiment, there are two positioning arms 66, and the two positioning arms 66 are disposed opposite to each other at a distance, and at least one positioning member 64 is disposed at the distal end of each positioning arm 66.

[0047] The outer sheath tube 62 may be a single-layer or multi-layer composite tube body. Preferably, the outer sheath tube 62 is made of an inner PTFE inner membrane, a middle metal braided reinforcement layer, and an outer Pebax material, and has a hollow inner cavity.

[0048] The positioning member 64 may also be a rod-shaped structure formed by at least one support rod, and the outer surface is smooth to avoid damaging the leaflets. The positioning member 64 is made of elastic and / or flexible material to adapt to the anatomical structure of the leaflets and the range of motion of the leaflets, and can effectively avoid damaging the leaflets. It can be made of metal material, polymer material or metal-polymer composite material. Preferably, the positioning member 64 is made of a material with shape memory function.

[0049] The positioning arm 66 is a support rod with an axial length. The support rod can be a solid or hollow structure of a single-layer or multi-layer composite structure, and can also be wound by a single wire or multiple wires. The cross-section of the support rod can be a regular circle or ellipse, crescent, semicircle, polygon, etc., preferably a circle. The positioning arm 66 preferably has a certain hardness or rigidity to provide a supporting force to facilitate the pushing of the positioning member 64.

[0050] The positioning member 64 and the positioning arm 66 can be an integral structure, or can be fixedly connected together by being non-detachable or detachable. That is, the positioning arm 66 and the positioning member 64 can be processed separately first, and then fixedly connected together by welding, bonding, sleeve connection, threaded connection, interference fit, etc.

[0051] The width of the positioning member 64 parallel to the radial direction is greater than the radial dimension of the positioning arm 66, so that the positioning member 64 has a larger supporting area, which is conducive to supporting the leaflet. The width direction of the positioning member 64 is the same as the width direction of the clamping arm.

[0052] The positioning member 64 may be a plate-like structure with or without elasticity, so that there is a larger contact area between the positioning member 64 and the leaflet, so as to better fit the leaflet and improve the support force for the leaflet. The positioning member 64 may also be an annular closed elastic ring, wherein the elastic ring may be a closed structure of a circle, diamond, ellipse, pear, polygon or other irregular shape; preferably, at least one support bar may be provided in the elastic ring to improve the stability of the elastic ring. The positioning member 64 of the stabilizing component 60 includes a plurality of branches, and the plurality of branches are stretched and opened to better fit the leaflet. The positioning member 64 may also be a mesh structure woven from elastic metal wires or polymer wires.

[0053] Preferably, each positioning member 64 is a deformable mesh cage. Specifically, the positioning member 64 is a cage-like structure woven from silk threads having a certain elasticity and tension. When the cage-like structure is received in the outer sheath 62, the positioning member 64 is squeezed and deformed and is in a compressed state; when the positioning member 64 extends out of the outer sheath, the cage-like structure stretches, and the volume of the stretched positioning member 64 is greater than the volume when it is squeezed, thereby providing more stable support for the leaflet. In the present application, the silk threads forming the cage-like structure may be elastic metal wires or polymer wires having shape memory function. In the present embodiment, the positioning member 64 is made of nickel-titanium wire having superelasticity.

[0054] The middle portion of the positioning member 64 in this embodiment is columnar, and the proximal end portion and the distal end portion are both cones, and the cone angles of the cones at both ends are the same. It is understandable that in the present application, the middle portion of the positioning member 64 can also be any other shape. For example, the positioning member 64 can be a spindle-shaped structure with the same cone angle at both ends, or a structure with different cone angles at both ends.

[0055] Preferably, the positioning member 64 is at least partially made of an X-ray non-transparent material, and the X-ray non-transparent material is selected from stainless steel or nickel-titanium alloy. Thus, before the clamping assembly 70 clamps the leaflet, after the positioning member 64 contacts the leaflet, the flexible or elastic positioning member 64 can swing accordingly with the movement amplitude of the leaflet, and the operator can judge the relative position between the edge-to-edge repair device 20 and the leaflet through X-rays, so as to operate the clamping assembly 70 more quickly and accurately to clamp the leaflet, shorten the operation time, and improve the success rate of the operation. In this embodiment, the positioning member 64 is a metal ball with a three-dimensional mesh cage structure formed by weaving nickel-titanium wire, which can not only provide more stable support for the leaflet supported by the positioning arm 66, but also has a more three-dimensional imaging effect.

[0056] Please also read Figure 2 and Fig.10The two clamping arms of the clamping assembly 70 include a first clamping arm 72 and a second clamping arm 74 which are hinged to each other near the proximal end, and the distal end of the first clamping arm 72 and the distal end of the second clamping arm 74 can be relatively opened and closed. The clamping assembly 70 also includes a pusher 75 and a fixing sleeve 77 for driving the relative opening and closing of the first clamping arm 72 and the second clamping arm 74. By controlling the opening and closing of the first clamping arm 72 and the second clamping arm 74, the puncture member 22 of the edge-to-edge repair device 20 can puncture the leaflet and be fixedly connected to the fixing member 24, and the edge-to-edge repair device 20 can also be released on the leaflet. Specifically, the pusher 75 moves axially toward the distal end to drive the distal ends of the first clamping arm 72 and the second clamping arm 74 away from each other; the pusher 75 moves axially toward the proximal end to drive the distal ends of the first clamping arm 72 and the second clamping arm 74 to move closer to each other, so that the puncture member 22 is combined with the fixing member 24.

[0057] like Fig.11 As shown, the first clamping arm 72 includes a hinged portion 721, a connecting plate 723 disposed at the proximal end of the hinged portion 721, and a clamping portion 725 disposed at the distal end of the hinged portion 721; a hinge hole 7210 is provided in the middle of the hinged portion 721 along the radial direction of the fixed sleeve 77, and a slide groove 7230 inclined to the axial direction is provided on the connecting plate 723. When the first clamping arm 72 is installed in the fixed sleeve 77, the hinge hole 7210 is parallel to the radial direction of the fixed sleeve 77, the distal end of the slide groove 7230 is close to the axis of the fixed sleeve 77, and the proximal end of the slide groove 7230 is far from the axis of the fixed sleeve 77. A positioning groove 7250 is provided on the side of the distal end of the clamping portion 725 facing the second clamping arm 74, and the shape of the positioning groove 7250 corresponds to the shape of the puncture member 22 or the fixing member 24, that is, the positioning groove 7250 is used to pre-install the puncture member 22 or the fixing member 24. Preferably, the distal end of the first clamping arm 72 is provided with spaced through holes 7252, each through hole 7252 is connected to the positioning groove 7250, the piercing member 22 or the fixing member 24 is provided with a threading hole, and after the piercing member 22 or the fixing member 24 is pre-installed in the positioning groove 7250, the suture or the nickel-titanium steel wire with a diameter of 0.2 mm is passed through the threading hole of the piercing member 22 or the fixing member 24 and the through hole 7252 of the first clamping arm 72, and the proximal end of the suture or the nickel-titanium steel wire extends from the proximal end of the first clamping arm 72.

[0058] In other embodiments, the positioning groove 7250 at the distal end of the first clamping arm 72 can be omitted, and an interval through hole 7252 is directly opened at the distal end of the side of the first clamping arm 72 facing the second clamping arm 74, and the piercing member 22 or the fixing member 24 is provided with a threading hole corresponding to the through hole 7252. The suture or nickel-titanium steel wire is inserted into the threading hole of the piercing member 22 or the fixing member 24 and the corresponding through hole 7252, and the proximal end of the suture or the nickel-titanium steel wire extends from the proximal end of the first clamping arm 72.

[0059] like Fig.13 and Fig.14 As shown, the structure of the second clamping arm 74 is similar to that of the first clamping arm 72. Specifically, the second clamping arm 74 includes a hinge portion 741, a connecting plate 743 arranged at the proximal end of the hinge portion 741, and a clamping portion 745 arranged at the distal end of the hinge portion 741; a hinge hole 7410 is provided in the middle portion of the hinge portion 741 along the radial direction of the fixed sleeve 77, and the connecting plate 743 is provided with a sliding groove 7430 inclined to the axial direction. When the first clamping arm 72 and the second clamping arm 74 are installed together in the fixed sleeve 77, the hinge hole 7210 of the first clamping arm 72 corresponds to the hinge hole 7410 of the second clamping arm 74, the distal end of the slide groove 7430 of the second clamping arm 74 is close to the axis of the fixed sleeve 77, the proximal end of the slide groove 7430 is far away from the axis of the fixed sleeve 77, and the slide groove 7230 of the first clamping arm 72 and the slide groove 7430 of the second clamping arm 74 are partially overlapped. The distal end of the clamping portion 745 faces the side of the first clamping arm 72 and is provided with a positioning groove 7450, the shape of which corresponds to the shape of the piercing member 22 or the fixing member 24, that is, the positioning groove 7450 is used to pre-install the piercing member 22 or the fixing member 24. Preferably, the distal end of the second clamping arm 74 is provided with spaced through holes 7452, each through hole 7452 is connected to the positioning groove 7450, the piercing member 22 or the fixing member 24 is provided with a threading hole, and after the piercing member 22 or the fixing member 24 is pre-installed in the positioning groove 7450, the suture or nickel-titanium steel wire is passed through the threading hole of the piercing member 22 or the fixing member 24 and the through hole 7452 of the second clamping arm 74, and the proximal end of the suture or the nickel-titanium steel wire extends from the proximal end of the second clamping arm 74.

[0060] In other embodiments, the positioning groove 7450 at the distal end of the second clamping arm 74 can be omitted, and an interval through hole 7452 is directly opened at the distal end of the side of the second clamping arm 74 facing the first clamping arm 72, and the piercing member 22 or the fixing member 24 is provided with a threading hole corresponding to the through hole 7452. The suture or nickel-titanium steel wire is inserted into the threading hole of the piercing member 22 or the fixing member 24 and the corresponding through hole 7452, and the proximal end of the suture or the nickel-titanium steel wire extends from the proximal end of the second clamping arm 74.

[0061] like Fig.15As shown, the pusher 75 includes a hollow cylindrical tube 752 at the proximal end and a connecting piece 754 of a flat structure at the distal end. The shape of the hollow cylindrical tube 752 is adapted to the shape of the inner cavity of the fixed sleeve 77, so that the pusher 75 can be gap-matched and axially slid in the inner cavity of the fixed sleeve 77. The inner cavity of the hollow cylindrical tube 752 is used to fix the distal end of the driving rod 522 of the push rod 52. The connecting piece 754 is used to adapt to the connecting plate 723 of the first clamping arm 72 and the connecting plate 743 of the second clamping arm 74 to reduce the outer diameter of the assembly after the first clamping arm 72, the second clamping arm 74 and the pusher 75 are assembled. Two protruding driving pins 7540 are radially arranged on opposite sides of the distal end of the connecting plate 723. The two driving pins 7540 are used to connect the slide groove 7230 of the first clamping arm 72 and the slide groove 7430 of the second clamping arm 74 respectively.

[0062] like Fig.16 As shown, the fixed sleeve 77 includes a connecting ring 772 and two branches 774 arranged at a distance from the distal end of the connecting ring 772 in the axial direction. The fixed sleeve 77 is sleeved outside the pusher 75; specifically, the pusher 75 can be movably accommodated in the inner cavity of the fixed sleeve 77. A receiving groove 775 is formed between the two branches 774, and the receiving groove 775 is used to accommodate the proximal ends of the pusher 75, the first clamping arm 72 and the second clamping arm 74. A through hole 7740 is respectively provided on the two branches 744 in the radial direction, and the through hole 7740 is used to connect with the first clamping arm 72 and the second clamping arm 74 through the connecting shaft 78.

[0063] The edge-to-edge repair system 100 also includes a control handle 54 arranged at the proximal end of the push rod 52, the push rod 52 includes a push tube 520 and a drive rod 522 movably inserted in the push tube 520, the proximal ends of the push tube 520 and the drive rod 522 are both connected to the clamping assembly 70; the control handle 54 is used to transport the edge-to-edge repair device 20, and by driving the drive rod 522 to move axially relative to the push tube 520, the two clamping arms of the clamping assembly 70 are driven to expand or close to each other.

[0064] Please also read Figures 10 to 17When assembling the clamping assembly 70, the connecting plate 723 of the first clamping arm 72 and the connecting plate 743 of the second clamping arm 74 clamp the connecting piece 754 of the pushing member 75, so that the positioning groove 7250 of the first clamping arm 72 faces the positioning groove 7450 of the second clamping arm 74, the hinge hole 7210 of the first clamping arm 72 faces the hinge hole 7410 of the second clamping arm 74, and the two driving pins 7540 of the pushing member 75 are respectively inserted into the positioning groove 7250 of the first clamping arm 72 and the positioning groove 7450 of the second clamping arm 74. The proximal end of the pusher 75 is inserted into the inner cavity of the fixed sleeve 77 from the distal end of the fixed sleeve 77 until the hinge hole 7210 of the first clamping arm 72 and the hinge hole 7410 of the second clamping arm 74 face the corresponding through hole 7740; the connecting shaft 78 is inserted into the through hole 7740 of the fixed sleeve 77 and the hinge hole 7210 of the first clamping arm 72 and the hinge hole 7410 of the second clamping arm 74, so that the first clamping arm 72 and the second clamping arm 74 can swing around the connecting shaft 78. The proximal end of the fixed sleeve 77 is fixedly connected to the distal end of the pusher tube 520, and the proximal end of the pusher 75 is connected to the driving rod 522 (such as a certain length) Figure 2 The proximal end of the driving rod 522 is connected to the patient's body and then connected to the control handle 54, so that the driving rod 522 can be moved axially relative to the push tube 520 to drive the push member 75 to advance toward the distal end or retreat toward the proximal end, so that the driving pin 7540 slides in the corresponding slide grooves 7230, 7430 to drive the first clamping arm 72 and the second clamping arm 74 to rotate relative to each other, that is, the distal end of the first clamping arm 72 and the distal end of the second clamping arm 74 are opened and closed to each other, thereby realizing the opening or closing of the clamping assembly 70 to capture or release the leaflet.

[0065] like Fig.17 As shown, in this embodiment, the angle range between the first clamping arm 72 and the second clamping arm 74 that can be opened is 0-90°, so as to facilitate the capture of the leaflets. The first clamping arm 72 and the second clamping arm 74 are both sheet-shaped, plate-shaped, petal-shaped or arc-shaped with a certain width, and are not specifically limited. The surfaces opposite to the first clamping arm 72 and the second clamping arm 74 are clamping surfaces in contact with the leaflets, and friction enhancement parts can be provided on the clamping surfaces, for example, convex teeth, waveforms, convex points, friction pads, barbs, etc. are provided on the clamping surfaces.

[0066] Please also read Figures 18 to 24 , the following uses the edge-to-edge repair of the mitral valve of the heart as an example to illustrate the use of the edge-to-edge repair system 100 provided by the present invention.

[0067] In the first step, before use, the edge-to-edge repair device 20 is pre-installed in the clamping assembly 70, that is, the puncture member 22 and the fixing member 24 are pre-installed in the positioning groove 7250 of the first clamping arm 72 and the positioning groove 7450 of the second clamping arm 74 respectively; puncture is performed from the apex position, and a guide wire (not shown) is sent to the mitral valve orifice; Fig.18 As shown, the outer sheath 62 is sent to the lower part of the valve edge along the guide wire through a guiding device such as an adjustable curved catheter (not shown), and the stabilizing component 60 (such as Fig.19 As shown in the figure), the free ends of the anterior leaflet 401 and the posterior leaflet 403 are confined between two positioning members 64, thereby limiting the movement of the leaflets to slow down the pulsation of the leaflets; at this time, the two positioning members 64 of the stabilizing component 60 will swing significantly under ultrasound to prove that the leaflets are confined.

[0068] The second step is, Fig. 20 As shown, the outer sheath 62 is fixed, and the push tube 520 is delivered through the inner cavity of the outer sheath 62. After reaching the lower edge of the valve leaflet, the driving rod 522 is pushed to the distal end to open the first clamping arm 72 and the second clamping arm 74, and then the clamping assembly 70 is slowly pushed to the distal end;

[0069] The third step is Fig.21 As shown, after the first clamping arm 72 and the second clamping arm 74 reach below the leaflet, the driving rod 522 is moved proximally to close the first clamping arm 72 and the second clamping arm 74, and the front leaflet 401 and the rear leaflet 403 respectively abut the puncture member 22 and the fixing member 24; at this time, if it is found that the swing amplitude of the two positioning members 64 is weakened compared with before, it means that the front leaflet 401 and the rear leaflet 403 are effectively clamped; if the front leaflet 401 and the rear leaflet 403 are not clamped, the first clamping arm 72 and the second clamping arm 74 are withdrawn to the proximal end of the leaflet edge, and then the clamping assembly 70 is pushed again and the driving rod 522 is moved proximally to close the first clamping arm 72 and the second clamping arm 74 again until the first clamping arm 72 and the second clamping arm 74 clamp the leaflet.

[0070] The fourth step is Fig. 22 and Fig.23 As shown, the puncture needle protective cover 227 is withdrawn by pulling the steel wire, and then the first clamping arm 72 and the second clamping arm 74 are closed, so that the puncture needle and the fixing member 24 are matched; Fig.24 As shown, the nickel-titanium steel wire inserted into the through hole 7252 of the first clamping arm 72 and the through hole 7452 of the second clamping arm 74 is withdrawn, thereby releasing the edge-to-edge repair device 20, and then the clamping assembly 70 and the stabilizing assembly 60 are withdrawn in turn to complete the edge-to-edge repair of the mitral valve.

[0071] Fig.25 and Fig. 27Another embodiment of the edge-to-edge repair device 20a of the present invention is shown. The edge-to-edge repair device 20a is similar to the edge-to-edge repair device 20, except that: the puncture member 22a of the edge-to-edge repair device 20a is provided with only one puncture portion 220 in the middle of the side facing the fixing member 24a, the fixing member 24 is provided with a receiving portion 243 corresponding to the puncture portion 220 on the side facing the puncture member 22a, the first anti-slip pad 225a is provided with a through hole corresponding to the puncture portion 220, and the second anti-slip pad 245a is provided with a through hole corresponding to the receiving portion 243. The puncture portion 220 of the puncture member 22a passes through the through hole of the first anti-slip pad 225a, and the first anti-slip pad 225a is exposed; the receiving portion 243 of the fixing member 24a is inserted into the second anti-slip pad 245a. When the puncture member 22a is engaged with the fixing member 24a, the puncture portion 220 of the puncture member 22a punctures the leaflet and then combines with the fixing member 24a, thereby effectively and quickly completing the edge-to-edge connection.

[0072] The above is an implementation of the embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the embodiment of the present invention. These improvements and modifications are also considered to be within the scope of protection of the present invention.

Claims

1. An edge-to-edge repair device, characterized in that: It comprises a puncture piece for implanting on one side of the leaflet and a fixing piece for implanting on the other side of the leaflet, the puncture piece comprises at least one puncture portion and a puncture base for puncturing the leaflet, the puncture portion is arranged on the side of the puncture base facing the fixing piece; the fixing piece comprises a fixing base and a receiving portion arranged on the side of the fixing base facing the puncture piece, a first anti-slip pad is arranged on the side of the puncture base facing the leaflet, and a second anti-slip pad is arranged on the side of the fixing base facing the leaflet; the puncture portion punctures the leaflet on one side and the leaflet on the other side in sequence and then is connected to the receiving portion, so that the leaflets on both sides are at least partially connected to the fixing piece through the puncture piece.

2. The edge-to-edge repair device according to claim 1, characterized in that: The puncture portion and the receiving portion are connected by interference fit, key connection, lock connection, snap connection or threaded connection.

3. The edge-to-edge repair device according to claim 2, characterized in that: The puncture portion comprises a tapered needle, the receiving portion is provided with a receiving cavity, and the needle is inserted into the receiving cavity.

4. The edge-to-edge repair device according to claim 3, characterized in that: The proximal end of the needle is provided with a convex tooth or a flange, and the side wall of the accommodating cavity is provided with a groove or a hole corresponding to the convex tooth or the flange. The needle is inserted into the accommodating cavity so that the convex tooth or the flange is stuck in the groove or the hole.

5. The edge-to-edge repair device according to claim 4, characterized in that: The first anti-skid pad and the second anti-skid pad are both made of biocompatible polymer material with a relatively high friction coefficient.

6. The edge-to-edge repair device according to claim 1, characterized in that: A protective sleeve is provided at the distal end of the puncture portion.

7. An edge-to-edge repair system, characterized in that: It comprises an edge-to-edge repair device and a conveying device as described in any one of claims 1 to 6, wherein the conveying device comprises a push rod and a clamping assembly, the proximal end of the clamping assembly is connected to the push rod, the clamping assembly comprises two clamping arms that can open and close relative to each other, the puncture member and the fixing member of the edge-to-edge repair device are pre-installed on the two clamping arms respectively, the push rod moves axially toward the proximal end to drive the two clamping arms to close each other, so that the puncture portion of the puncture member punctures the valve leaflet and then combines with the fixing member.

8. The edge-to-edge repair system according to claim 7, characterized in that: The edge-to-edge repair system further includes a stabilizing component, which includes an outer sheath tube sleeved outside the push rod and a positioning member arranged at the distal end of the outer sheath tube, and the positioning member is used to support the valve leaflet.

9. The edge-to-edge repair system according to claim 8, characterized in that: The stabilizing component also includes a positioning arm movably installed in the outer sheath tube, the distal end of the positioning arm extends out of the outer sheath tube, and the positioning member is arranged at the distal end of the positioning arm.

10. The edge-to-edge repair system according to claim 9, characterized in that: The positioning member extends out of the outer sheath tube as the positioning arm moves axially and extends obliquely away from the axis of the outer sheath tube. The angle between the axial direction of the positioning member and the axial direction of the positioning arm is in the range of 120 degrees to 150 degrees.

11. The edge-to-edge repair system according to claim 9, characterized in that: There are two positioning arms, which are arranged opposite to each other at a distance. The distal end of each positioning arm is provided with at least one positioning member, and each positioning member extends from the distal end of the positioning arm connected thereto away from the axis and obliquely toward the distal end.

12. The edge-to-edge repair system of claim 9, wherein: The width of the positioning member parallel to the radial direction is greater than the radial dimension of the positioning arm.

13. The edge-to-edge repair system according to claim 12, characterized in that: The positioning member is a deformable mesh cage; the middle portion of the mesh cage is columnar, and the proximal end portion and the distal end portion are both cones.

14. The edge-to-edge repair system of claim 9, wherein: The positioning element is at least partially made of an X-ray opaque material.

15. The edge-to-edge repair system of claim 7, wherein: The adjacent proximal ends of the two clamping arms are hinged to each other, and the clamping assembly also includes a pushing member, which moves axially toward the distal end to drive the distal ends of the two clamping arms away from each other; the pushing member moves axially toward the proximal end to drive the distal ends of the two clamping arms closer to each other, so that the fixing member is combined with the puncture member.

16. The edge-to-edge repair system of claim 15, wherein: The proximal ends of the two clamping arms are respectively provided with a slide groove inclined to the axial direction, and the pushing member includes a driving pin slidably inserted in the slide groove, and the driving pin slides in the slide groove to drive the two clamping arms to rotate relative to each other.

17. The edge-to-edge repair system of claim 15, wherein: The clamping assembly also includes a fixed sleeve sleeved outside the pushing member, the distal end of the fixed sleeve is provided with two branches spaced opposite to each other along the axial direction, and the proximal ends of the two clamping arms are accommodated between the two branches and connected by a connecting shaft.

18. The edge-to-edge repair system of claim 11, wherein: Each clamping arm is provided with spaced through holes at the distal end of the side surface facing the other clamping arm, the piercing member and the fixing member are respectively provided with threading holes, the piercing member and the fixing member are respectively placed between the two clamping arms, at least one suture is passed through the threading hole of the piercing member and the corresponding through hole of the clamping arm, at least one suture is passed through the threading hole of the fixing member and the corresponding through hole of the clamping arm, and the proximal end of each suture extends from the proximal end of the clamping arm.

19. The edge-to-edge repair system of claim 11, wherein: A positioning groove is provided at the distal end of the side surface of each clamping arm facing the other clamping arm, and the piercing element and the fixing element are pre-installed in the positioning grooves of the two clamping arms respectively.

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