Transcatheter implant instrument for valve repair

Abstract

The invention relates to a transcatheter implantation instrument for valve repair, comprising: a filling component comprising a filling main body and two support members, the two support members being arranged at the distal end of the filling main body, each support member comprising an inner arm and an outer arm, the filling main body, the inner arm and the outer arm being sequentially connected along the axial direction of the filling main body; the capturing part comprises two elastic clamps, and each elastic clamp is connected with the corresponding inner arm; the clamping component comprises a plurality of clamping bodies arranged in the circumferential direction of the filling body, the far end of each clamping body is connected with the far end of the supporting piece, and the near end of each clamping body is movably connected with the corresponding inner arm and / or outer arm through at least one connecting piece. The two sides, in the circumferential direction of the filling body, of any inner arm and / or any outer arm are / is connected with at least one clamping body. In this way, the clamping and fastening effect of the instrument on the valve leaflets can be improved, and the instrument can be suitable for the valve leaflets of different sizes.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to a transcatheter implantable device for valve repair. Background Art

[0002] The mitral valve and tricuspid valve are two very important valves in the heart, similar to a check valve, which are an important heart structure that prevents blood from flowing from the left atrium to the left ventricle or from the right atrium to the right ventricle and cannot flow back. Mitral regurgitation or tricuspid regurgitation is the phenomenon that blood flows back from the ventricle to the atrium due to the lax closure of the mitral valve or tricuspid valve. This backflow will cause the patient to have the risk of heart failure and seriously affect the patient's daily life and work. Mitral regurgitation or tricuspid regurgitation is the two most common symptoms of valvular heart disease, and the treatment is relatively troublesome and costly. It is usually treated by open-chest surgery, which has a high surgical risk. Another way to treat mitral regurgitation or tricuspid regurgitation is transcatheter interventional minimally invasive surgery, in which the implant device is implanted into the patient's heart through a transcatheter delivery system to achieve the edge-to-edge double-hole repair effect of the mitral or tricuspid valve leaflets, thereby achieving the inhibition of mitral regurgitation or tricuspid regurgitation and achieving the effect of treating the patient's mitral regurgitation or tricuspid regurgitation.

[0003] Existing transcatheter implantation devices for mitral or tricuspid valves are usually mechanical clips or elastic clips that clamp the mitral or tricuspid valve leaflets to achieve edge-to-edge repair, thereby suppressing mitral or tricuspid regurgitation and achieving the therapeutic effect of mitral or tricuspid regurgitation. The mechanical clip usually includes a linkage mechanism to realize the transmission of the opening, capturing and locking actions of the implant, a pair of mechanical clips with many barbs to realize the capture, hanging and pulling of the leaflets to the middle to achieve the edge-to-edge double-hole repair state, and a locking mechanism to make the implant closed and locked after the edge-to-edge clamping. The structure of the elastic clamp is different from that of the mechanical clamp. It mainly consists of an elastic spacer, which is used to reduce the leaflet stress generated when the clamp is clamped to the middle of the leaflet to avoid leaflet tearing, a pair of elastic clips, which are used to capture the leaflet and pull the leaflet to the middle to achieve edge-to-edge double-hole repair state, and a pair of elastically supported clamps to achieve the support of the elastic spacer and the tightening of the closed state, ensuring that the elastic clamp can stably achieve the three states of deployment, capture and closure. At the same time, the elastic clamp can usually realize the function of individual control and capture of the clip. In addition, some clamps use double-layer clips to fit and capture, and use a lifting and locking structure, which can also achieve the therapeutic effect of double-hole repair to inhibit mitral or tricuspid regurgitation.

[0004] Mechanical clamps are prone to causing large clamping stress, which can cause the leaflets of the valve to tear. However, since the clamping force of elastic clamps relies on the elastic force of the elastic element itself to achieve clamping and tightening, if the clamping force is inappropriate or irreversible or reversible plastic deformation occurs during the operation of the elastic element, the leaflet capture range will change, which will affect the applicable range of the leaflets and the final clamping effect, affecting the treatment effect of mitral regurgitation or tricuspid regurgitation after the final implantation. The existing elastic clamps mainly use barbs to achieve clamping and limiting effects. The barbs are embedded in the leaflets, and the contact area of ​​the barbs is small, and the limiting effect is limited, which can easily cause leaflet tearing, affect the clamping effect, and cause valve tearing or loose edge-to-edge fit, increasing the risk of recurrence of mitral regurgitation or tricuspid regurgitation.

[0005] It should be noted that the information disclosed in the background technology section of this application is only intended to deepen the understanding of the general background technology of this application, and should not be regarded as an admission or any form of implication that the information constitutes prior art already known to those skilled in the art. Summary of the invention

[0006] The object of the present invention is to provide a transcatheter implantation device for valve repair, so as to solve the problems of the existing valve clamping, such as the valve leaflets are easy to tear and the clamping is not firm.

[0007] To achieve the above object, the present invention provides a transcatheter implantable device for valve repair, comprising:

[0008] A filling component, comprising a filling body and two support members, wherein the two support members are arranged at the distal end of the filling body, each of the support members comprises an inner arm and an outer arm, and the filling body, the inner arm and the outer arm are sequentially connected along the axial direction of the filling body;

[0009] a capture component, comprising two elastic clips, each of which is connected to a corresponding one of the inner arms; and

[0010] The clamping component includes a plurality of clamping bodies arranged along the circumference of the filling body, the distal end of each of the clamping bodies being connected to the distal end of the support member, the proximal end of each of the clamping bodies being movably connected to the corresponding inner arm and / or outer arm through at least one connecting member, and any one of the inner arm and / or the outer arm being respectively connected to at least one of the clamping bodies on both sides along the circumference of the filling body.

[0011] In one embodiment, the proximal end of each of the clamping bodies is movably connected to the corresponding inner arm and / or outer arm via a connecting member.

[0012] In one embodiment, the connection point between one side of any one of the inner arms and the connecting member and the connection point between the other side of the inner arm and the connecting member are arranged on the same circumference or on different circumferences, and / or, the connection point between one side of any one of the outer arms and the connecting member and the connection point between the other side of the outer arm and the connecting member are arranged on the same circumference or on different circumferences.

[0013] In one embodiment, one end of the connecting member can be movably mounted on the eyelet of the corresponding inner arm and / or the outer arm, and the other end can be movably mounted on the connecting hole of the corresponding clamping body, or the connecting member can be movably inserted into the corresponding inner arm and / or the outer arm and then pass out from one side of the corresponding inner arm and / or the outer arm along the circumferential direction, and then can be movably inserted into and out of the connecting hole on the corresponding clamping body to form a ring.

[0014] In one embodiment, the connection hole penetrates the clamp body in the thickness direction of the clamp body, and the thickness of the clamp body is the dimension in the direction of clamping the target tissue.

[0015] In one embodiment, the connecting member is a flexible structure or a rigid structure, so that the clamping body can adjust the clamping position and clamping direction.

[0016] In one embodiment, there are four clamping bodies, and any one of the inner arms and / or the outer arms is connected to one clamping body on both sides along the circumference of the filling body, and the four clamping bodies are symmetrically arranged in groups of two about the filling body.

[0017] In one embodiment, each of the elastic clips is provided with at least one row of barbs, the row of barbs are distributed along the circumference of the elastic clip, and the position of the row of barbs is closer to or farther away from the central axis of the filling body in the radial direction of the filling body than the position of the connecting piece below the elastic clip.

[0018] In one embodiment, the transcatheter implantable device has at least an extended state, a captured state and a closed state, and can be transformed between these states. In the closed state, any one of the inner arms and / or the outer arms, all the clamps connected thereto and all the connecting parts can surround the target tissue and present a convex shape.

[0019] In one embodiment, each of the elastic clips is provided with at least one row of barbs, the row of barbs is distributed along the circumference of the elastic clip, the barbs include first barbs and second barbs, and the length of the first barbs is greater than the length of the second barbs.

[0020] As described above, in the transcatheter implantation device for valve repair provided by the present invention, a plurality of independent clamping bodies are used to elastically support the two support members, and the inner arm and / or outer arm in each support member is connected to the corresponding clamping body, and in particular, the proximal end of each clamping body is movably connected to the corresponding inner arm and / or outer arm through at least one connecting member, rather than being fixedly connected. The movable connection of the connecting member allows the clamping body and the inner arm and / or outer arm connected thereto to produce a certain displacement, so that the position and direction of the clamping body clamping the target tissue can be flexibly adjusted through the connecting member. In this way, the target tissue (such as the valve leaflet) can be firmly clamped between the clamp body, the inner arm and the connector. The clamp body can apply force to the inner arm connected to it through the connector, and effectively pull the inner arm inward to tighten and clamp the target tissue, so that the scope of application of the valve leaflet is wider, the valve leaflet capture is more secure, and the valve leaflet is not easy to fall off after capture, which can improve the success rate of device implantation and reduce the risk of implantation failure, making the device implantation safer, more reliable and stable. At the same time, it also reduces the difficulty of operation and operation time during the operation, improves the safety and reliability of the operation, reduces the risks caused by the device during the operation, and is beneficial to inhibiting the patient's mitral valve regurgitation or tricuspid valve regurgitation. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Those skilled in the art will appreciate that the accompanying drawings are provided for a better understanding of the present invention and do not constitute any limitation on the scope of the present invention.

[0022] Figure 1 It is a partially cutaway cross-sectional view of a transcatheter implantable device according to an embodiment of the present invention, wherein the polymer coating is not shown;

[0023] Figure 2 It is a top view of the transcatheter implantable device according to an embodiment of the present invention in a closed state, and the polymer coating is not shown;

[0024] Figure 3 This is a technical principle diagram of a transcatheter implantation device clamping valve leaflets from the atrium to the ventricle in an embodiment of the present invention, wherein the clamped valve leaflets present an outward convex shape;

[0025] Figure 4 It is a cross-sectional view of the whole of the transcatheter implantation device according to an embodiment of the present invention;

[0026] Figure 5 It is a schematic diagram of a transcatheter implantable device in an extended state according to an embodiment of the present invention;

[0027] Figure 6 It is a schematic diagram of a transcatheter implantation device in a capture state according to an embodiment of the present invention, wherein the elastic clip is connected to a clip control line;

[0028] Figure 7It is a schematic diagram of a transcatheter implantation device in a capture state according to an embodiment of the present invention, wherein the clip control line is not shown;

[0029] Figure 8 is a schematic diagram of a transcatheter implantable device in a closed state according to an embodiment of the present invention, wherein the delivery system has been separated from the device;

[0030] Fig. 9 This is a schematic structural diagram of a second splint according to an embodiment of the present invention;

[0031] Fig.10 It is a schematic structural diagram of a proximal fixing member according to an embodiment of the present invention;

[0032] Fig.11 It is an exploded view of the assembly of the clamping body, the fixing member, the push wire connector, the distal fixing member and the covering member according to the embodiment of the present invention.

[0033] In the attached figure:

[0034] 1-filling component; 11-filling body; 12-first support member; 13-second support member; 14-first inner arm; 15-second inner arm; 16-first outer arm; 17-second outer arm; 2-proximal fixing member; 21-first clamping head; 22-second clamping head; 23-center through hole; 3-distal fixing member; 4-capturing component; 41-first elastic clip; 42-second elastic clip; 43-first clamping plate; 44-second clamping plate; 441-bottom plate; 442-barb; 442a-first barb; 442b-second barb; 5-clamping component; 51-clamping body; 6-fixing member; 7-push wire joint; 8-covering member; 9-connecting member; 10-polymer coating; 101, 102-clip control line; 103-push wire. DETAILED DESCRIPTION

[0035] In order to make the purpose, advantages and features of the present invention clearer, the present invention is further described in detail below in conjunction with the accompanying drawings and specific embodiments. It should be noted that the drawings are all in a very simplified form and are not drawn to scale, and are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention. In addition, the structure shown in the drawings is often a part of the actual structure. In particular, the emphasis of each drawing is different, and sometimes different scales are used.

[0036] As used in the present invention, the singular forms "one", "an" and "the" include plural objects, the term "or" is generally used to include the meaning of "and / or", the term "several" is generally used to include the meaning of "at least one", and the term "at least two" is generally used to include the meaning of "two or more". In addition, the terms "first", "second", etc. are only used for descriptive purposes and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, the features defined as "first", "second", etc. may explicitly or implicitly include one or at least two of the features, the terms "one end" and "the other end" and "proximal end" and "distal end" generally refer to two corresponding parts, which include not only endpoints, and 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 one; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements. In addition, as used in the present invention, an element disposed on another element generally only indicates that there is a connection, coupling, cooperation or transmission relationship between the two elements, and the connection, coupling, cooperation or transmission between the two elements may be direct or indirect through an intermediate element, and cannot be understood as indicating or implying the spatial position relationship between the two elements, that is, one element may be in any orientation such as inside, outside, above, below or on one side of another element, unless otherwise clearly indicated in the content. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0037] In the description of this application document, it should be understood that "proximal" and "distal" are relative to the reference direction from the perspective of the surgical operator during the operation, the direction close to the surgical operator is the "proximal" and the direction away from the surgical operator is the "distal". In the description of this application document, the term "axial" refers to the direction along the central axis of the implanted device, "radial" refers to the direction perpendicular to the axial direction, and "circumferential" refers to the direction around the central axis of the implanted device.

[0038] The purpose of the present invention is to provide a transcatheter implantable device for valve repair (hereinafter referred to as the transcatheter implantable device) to solve the problems of the existing valve clamping, such as easy tearing of the valve leaflets and loose clamping.

[0039] The transcatheter implantable device of the present invention can be applied to the mitral valve or the tricuspid valve to achieve edge-to-edge repair of the mitral valve or the tricuspid valve, and the access method is not limited, for example, it can be implanted via the femoral vein or the apical route.

[0040] The following description is given with reference to the accompanying drawings.

[0041] like Figure 1 to Figure 3As shown, the transcatheter implantation device provided by the present invention includes a filling component 1, a capturing component 4 and a clamping component 5.

[0042] The filling component 1 includes a filling body 11 and two support members, the two support members are a first support member 12 and a second support member 13. The two support members are arranged at the distal end of the filling body 11 and are connected to the filling body 11. The support members and the filling body 11 can be connected in an integrally formed manner or in a split-formed manner. The filling component 1 as a whole is preferably formed by weaving metal wires or cutting metal tubes. As an example, the filling component 1 as a whole is formed by weaving nickel-titanium alloy wires as a whole, and then the shape is fixed and superelasticity is achieved through a heat setting process. The first support member 12 and the second support member 13 are distributed circumferentially around the filling body 11 outside the filling body 11, and are usually symmetrically distributed circumferentially.

[0043] Each support member includes an inner arm and an outer arm, and the inner arm and the outer arm are usually integrally formed, for example, the inner arm and the outer arm are an integrally formed metal braided structure. Among them, the filling body 11, the inner arm and the outer arm are sequentially connected along the axial direction of the filling body 11. In one embodiment, the filling body 11 and the support member are integrally formed, for example, the filling body 11 and the support member are an integrally formed metal braided structure. Specifically, the first support member 12 includes a first inner arm 14 and a first outer arm 16, which are connected end to end in sequence. The proximal end of the first inner arm 14 is connected to the distal end of the filling body 11, and the distal end of the first outer arm 16 is usually bound and fixed by a joint component. The second support member 13 includes a second inner arm 15 and a second outer arm 17, which are connected end to end in sequence. The proximal end of the second inner arm 15 is connected to the distal end of the filling body 11, and the distal end of the second outer arm 17 is usually bound and fixed by the joint component.

[0044] In addition, the capturing component 4 is arranged on the outside of the filling component 1. The capturing component 4 includes two elastic clips, specifically a first elastic clip 41 and a second elastic clip 42. Each elastic clip is connected to a corresponding inner arm. During actual use, the leaflets can be inserted between each elastic clip and the inner arm connected thereto, so as to clamp the leaflets through the inner arm and the elastic clip, and clamp the leaflets in the elastic clip. Before clamping the leaflets, the elastic clip is opened to capture the leaflets first, and then the inner arm is closed for clamping. In more detail, the first elastic clip 41 is arranged on the first inner arm 14, and is connected and fixed to the first inner arm 14, for example, by suturing or other means. The second elastic clip 42 is arranged on the second inner arm 15, and is connected and fixed to the second inner arm 15, for example, by suturing or other means. The first elastic clip 41 and the second elastic clip 42 are both used to capture the leaflets, and both can capture the leaflets individually or simultaneously. In addition, the filling body 11 can be used to be placed between the leaflets that are attached edge to edge to avoid the risk of leaflet tearing due to excessive leaflet stress caused when the first elastic clip 41 and the second elastic clip 42 with elastic support and relief function are pulled to the leaflet attachment state.

[0045] Continue to refer to Figures 1 to 3 , the clamping part 5 includes a plurality of clamping bodies 51 arranged along the circumference of the filling body 11, and the clamping bodies 51 may be four or more than four. Taking four clamping bodies 51 as an example, in this embodiment, every two clamping bodies 51 form a group, forming two groups, and the two groups of clamping bodies 51 are connected to the two inner arms one-to-one, that is, each inner arm is only connected to two clamping bodies 51, and every two clamping bodies 51 are connected to the same inner arm along the circumference of the filling body 11 on both sides, so that each inner arm has a connection point on both sides along the circumference. Alternatively, the two groups of clamping bodies 51 are connected to the two outer arms one-to-one, so that each outer arm is only connected to two clamping bodies 51, and every two clamping bodies 51 are connected to the same outer arm along the circumference of the filling body 11 on both sides, so that each outer arm has a connection point on both sides along the circumference. Alternatively, at least two clamping bodies 51 are arranged on the same side of the corresponding support member along the circumferential direction, and these clamping bodies 51 are respectively connected to the inner arm and the outer arm of the same support member. Alternatively, at least two clamping bodies 51 are arranged on the same side of the corresponding support member along the circumferential direction, and these clamping bodies 51 are simultaneously connected to the inner arm or the outer arm of the same support member. Multiple clamping bodies 51 on the same side can be overlapped or arranged side by side, so as to increase the positioning points and make the clamping bodies 51 wrap the positioning leaflets with better effect.

[0046] In more detail, the distal end of each clamp 51 is connected to the distal end of the support member, which is the distal end of the filling member 1, and the proximal end of each clamp 51 is connected to the corresponding inner arm and / or outer arm. In particular, the proximal end of each clamp 51 is movably connected to the corresponding inner arm and / or outer arm through at least one connecting member 9, rather than being fixedly connected. Moreover, at least one clamp 51 is connected to both sides of the circumference of the filling body 11 of any inner arm, or at least one clamp 51 is connected to both sides of the circumference of the filling body 11 of any outer arm, or at least one clamp 51 is connected to both sides of the circumference of the filling body 11 of any inner arm and any outer arm. At least one clamp 51 is connected to both sides of the circumference of the filling body 11 of any inner arm and any outer arm. By connecting at least one clamp 51 to both sides of the circumference of the same support member 11, the effect of wrapping and positioning the leaflets can be better. It should also be noted that the clamp 51 can also be connected at the connection between the inner arm and the outer arm.

[0047] Reference Figure 2According to an embodiment of the present invention, the first inner arm 14 is movably connected to the two clamping bodies 51 along both sides of the circumference of the filling body 11 through the connecting piece 9, and the second inner arm 15 is movably connected to the other two clamping bodies 51 along both sides of the circumference of the filling body 11 through the connecting piece 9. The movable connection of the connecting piece 9 allows the clamping body 51 and the inner arm and / or outer arm connected thereto to generate a certain displacement, so that the position of the clamping leaflet of the clamping body 51 can be flexibly adjusted through the connecting piece 9. Compared with the traditional arc-shaped clamping leaflet, the present invention increases the force application point through the movable connecting piece 9, so that the leaflet can be firmly clamped between the clamping body 51, the inner arm (the first inner arm 14 or the second inner arm 15) and the connecting piece 9. The clamping body 51 can apply force to the inner arm connected thereto through the connecting piece 9, and effectively pull the inner arm inward to tighten and clamp the leaflet. Not only is it applicable to a wider range of leaflets, the leaflets are captured more firmly, and the leaflets are not easy to fall off after capture, which can improve the success rate of device implantation and reduce the risk of implantation failure, making device implantation safer, more reliable and stable. At the same time, it also reduces the difficulty of operation and the time of operation during the operation, improves the safety and reliability of the operation, reduces the risks caused by the device during the operation, and is beneficial to inhibiting the patient's mitral valve regurgitation or tricuspid valve regurgitation. It is understandable that during actual use, the connector 9, the inner arm and the clamping body 51 can present a triangular support state, so that the connector 9, the clamping body 51 and the inner arm present a certain angle, so that the leaflet can be more closely attached to the outer wall of the leaflet during the clamping process, and at the same time, the leaflet anchoring point is increased. During the clamping process, the clamping body 51 has a certain inward recovery force, and the distal end of the clamping body 51 abuts against the leaflet, thereby straightening the connector 9, and part of the leaflet is squeezed into the depression formed by the connector 9, the inner arm and the clamping body 51. The leaflet clamping is more firm, and it can also be applied to leaflets of different sizes and thicknesses, especially leaflets of different thicknesses. Leaflets of different thicknesses can be understood as the current leaflets themselves having different thicknesses, or the leaflets of different patients or individuals have different thicknesses. Even if the thickness of the same leaflet is different, the position and angle of the connector 9 can be adjusted through flexible connection, so that the connector 9, the clamping body 51 and the inner arm can fit the outer wall of the leaflet, ensuring the clamping and tightening effect of the leaflet.

[0048] In the exemplary embodiment shown in the figure, there are four clamping bodies 51, and the four clamping bodies 51 are arranged in groups of two, and are installed symmetrically or asymmetrically in the circumferential direction of the filling body 11. Preferably, the two groups of clamping bodies 51 are installed symmetrically about the filling body 11, and the clamping positioning effect is good and more stable. Each clamping body 51 itself has elasticity, and is usually made of nickel-titanium alloy after laser cutting and heat setting. The clamping body 51 can play an elastic supporting role during the operation of the transcatheter implant device, and when the transcatheter implant device is in a closed state, it can make the first support member 12 and the second support member 13 of the clamped leaflet converge toward the central axis direction of the filling body 11, so that the clamping state of the transcatheter implant device when closed is more stable and reliable.

[0049] The connector 9 selected by the present invention can be a rigid structure that is not easily elongated, has a certain elasticity and hardness, and forms a relatively stable anchor point. In other embodiments, the connector 9 adopts a deformable flexible structure, has a certain strength and deformation ability, and is not easy to break. "Flexibility" is relative to "rigidity", which is easier to deform than a rigid structure. In practice, the connector 9 cannot be too soft and should not be elongated as much as possible to ensure stability during clamping and tightening. The connector 9 can be in various forms, such as linear or strip or sheet or rod or tubular structures with a certain elasticity, hardness and strength. The connector 9 can be made of a flexible material or a rigid material with good elasticity. Preferably, the connector 9 is made of nickel-titanium alloy, or a chain-like structure.

[0050] Optionally, the connecting member 9 is connected with the clamping body 51 and the supporting member (such as the inner arm and / or the outer arm) to form a ring, for example, a coil, a flange, a clamp or other structures can be used to achieve the ring connection, which has a simple structure, is easy to manufacture and install, and has a low manufacturing cost. Not limited to this, in other embodiments, the connecting member 9 is, for example, one or more wound wires, one end of which can be movably mounted on the corresponding inner arm and / or outer arm eyelet, and the other end can be movably mounted on the corresponding connecting hole of the clamping body 51.

[0051] like Figure 2 As shown, in one embodiment, the connecting member 9 can be movably inserted into the corresponding inner arm and then pass out from one side of the inner arm along the circumferential direction, and then can be movably inserted into and out of the connecting hole on the clamping body 51 to form a loop. In other embodiments, the connecting member 9 can be movably inserted into the corresponding outer arm and then pass out from one side of the outer arm along the circumferential direction, and then can be movably inserted into and out of the connecting hole on the clamping body 51 to form a loop, or the connecting member 9 can be movably inserted into the corresponding inner arm and outer arm at the same time and then pass out from one side of the inner arm and outer arm along the circumferential direction, and then can be movably inserted into and out of the connecting hole on the clamping body 51 to form a loop. Taking the coil as an example, and taking the first inner arm 14 as an example, the connecting member 9 can be movably inserted into the first inner arm 14 and then pass out from one side of the first inner arm 14 along the circumferential direction, and then can be movably inserted into and out of at least one connecting hole on the proximal end of the clamping body 51 to connect to form a coil, and the coil can move freely. However, the coil is only an exemplary form of the connecting member 9 of the present invention. The connecting member 9 of the present invention can also be implemented by other structures, as long as the connection between the clamping body 51 and the inner arm and / or the outer arm is not a fixed connection.

[0052] The number of the connection holes on the clamping body 51 can be one or more, preferably one. The opening direction of the connection holes on the clamping body 51 is preferably along the thickness direction of the clamping body 51, so that the inner arm can be pulled inward to tighten the leaflets more effectively. In this way, the connection holes are set through the clamping body 51 in the thickness direction of the clamping body 51, and the thickness of the clamping body 51 is the dimension in the direction of the clamping leaflets. For details, see Figure 2 .

[0053] The proximal end of each clamping body 51 is preferably movably connected to the corresponding inner arm and / or outer arm through a connecting piece 9. In this way, the structure can be better simplified while satisfying the clamping and tightening effect. In addition, the connection point between one side of any inner arm and the connecting piece 9 and the connection point between the other side of the inner arm and the connecting piece 9 can be arranged on the same circumference or on different circumferences, and / or the connection point between one side of any outer arm and the connecting piece 9 and the connection point between the other side of the outer arm and the connecting piece 9 can be arranged on the same circumference or on different circumferences. Preferably, the connection points on both sides of the same inner arm and / or the same outer arm are arranged on the same circumference, so that the force is more uniform and the clamping effect is better. For example Figure 2 As shown, in this embodiment, both sides of the first inner arm 14 along the circumferential direction are connected to a connecting piece 9, and the connecting points on both sides are basically arranged on the same circumference, that is, the distances to the central axis of the filling body 11 are basically the same.

[0054] The transcatheter implantable device of the present invention is delivered to the native valve annulus by a delivery system. The delivery system can control the shape of the transcatheter implantable device and enable the transcatheter implantable device to switch between different shapes to meet the requirements of use at different stages. The transcatheter implantable device of the present invention has at least an extended state, a captured state and a closed state, and can switch between these states. For details, see Figures 5 to 8 .

[0055] Figure 5 The diagram shows the extended state of the transcatheter implantable device when it is delivered in the sheath of the delivery system, and then delivered to the atrium (such as the left atrium or the right atrium) through the delivery system, and then the device is pushed out of the distal end of the sheath and released. After release, the transcatheter implantable device is first transformed into Figure 8 The closed state is then changed to Figure 6 and Figure 7 In the capture state, the transcatheter implant device is inserted between the leaflets so that the first support member 12 and the second support member 13 are located below the leaflets. Thereafter, the elastic clip is lowered to allow the elastic clip to capture the leaflets. After the leaflets are successfully captured, the transcatheter implant device is changed from the capture state to the Figure 7 The closed state (i.e., clamped state) is shown, and the delivery system is then withdrawn.

[0056] Preferably, in the closed state, any inner arm and / or all the clamping bodies 51 and all the connecting members 9 connected thereto can surround the leaflet and present an outward convex shape, and form a force application point at the end of each clamping body 51. More specifically, Figure 3 As shown, when the leaflet is clamped at the connection position between the clamp body 51 and the connector 9, the inner arm, the clamp body 51 and the connector 9 will fit the outer wall of the leaflet, and the inner wall of the leaflet is anchored by the elastic clip and attached to the outer surface of the filling body 11. At this time, due to the flexibility (i.e., the mobility) of the connector 9, the inner arm, the clamp body 51 and the connector 9 will surround the leaflet to present, for example, a convex shape, a wavy shape or other convex shapes. This type of clamping and wrapping has better reliability and stability, and the clamping is tighter. It should also be noted that Figure 3 The two dotted lines A in the figure represent the outer contours of the two leaflets after being surrounded and clamped by the inner arm, the clamping body 51 and the connecting piece 9, and each dotted line A represents the state of a leaflet after being clamped. As a result, the clamping body 51 applies an inward force to the outer wall of the leaflet, and the force is perpendicular to the leaflet surface and presents a certain angle, which is less than or equal to 90°. In this way, the force can be perpendicular to the leaflet surface or not perpendicular to the leaflet surface to improve the stabilization effect of the clamped leaflet and reduce the risk of falling off.

[0057] As mentioned above, the transcatheter implantation device of the present invention can be used to clamp leaflets of different sizes, especially leaflets of different thicknesses. When the leaflets have different sizes or thicknesses, the connector 9, the inner arm and the clamping body 51 that fit the leaflets can flexibly adjust the deflection at a certain angle to fit the leaflets more closely. Even if the thickness of the leaflets on the left and right sides are different, the connector 9 can flexibly rotate a certain angle, so that the leaflets on the left and right sides can be stably fixed. The force applied to the leaflets at different angles or cross angles can provide a larger and more flexible clamping force, as well as a more accurate limiting effect, thereby increasing the scope of application of the transcatheter implantation device, and improving the clamping and tightening effect, further improving the success rate of the device implantation, making the device implantation safer, more reliable, and more stable. At the same time, it can also further reduce the difficulty of operation and the operation time during the operation, and reduce the risks caused by the device during the operation. In this way, the device has a wide range of application and good flexibility.

[0058] Reference Figure 1In some embodiments, the first elastic clip 41 and the second elastic clip 42 both include a first clamping plate 43 and a second clamping plate 44. The first clamping plate 43 of the first elastic clip 41 is directly connected to the first inner arm 14, the first clamping plate 43 is close to and fits the first inner arm 14, and preferably, the first clamping plate 43 is parallel to the first inner arm 14. One end of the second clamping plate 44 of the first elastic clip 41 (corresponding to one end of the inner arm, that is, the end closer to the central axis of the filling body 11) is elastically connected to the first clamping plate 43 of the first elastic clip 41, so that the second clamping plate 44 is applied with elastic force toward the first clamping plate 43. Similarly, the first clamping plate 43 of the second elastic clip 42 is directly connected to the second inner arm 15, the first clamping plate 43 is close to and fits the second inner arm 15, and preferably, the first clamping plate 43 is parallel to the second inner arm 15. One end of the second clamping plate 44 of the second elastic clamp 42 (corresponding to the end of the inner arm, i.e. the end closer to the central axis of the filling body 11) is elastically connected to the first clamping plate 43 of the second elastic clamp 42, so that the second clamping plate 44 is exerted with elastic force toward the first clamping plate 43.

[0059] Taking the first elastic clip 41 as an example, since the second clamp 44 is elastically connected to the first clamp 43, the second clamp 44 is applied with elastic force toward the first clamp 43, and the first clamp 43 is fixed to the first inner arm 14, then the second clamp 44 can be opened compared with the first clamp 43 under the action of external force. Specifically, an external force roughly in the proximal direction is applied to the second clamp 44, so that the second clamp 44 and the first clamp 43 are opened, roughly in a “>” shape, so as to capture the leaflet, so that the leaflet enters between the first clamp 43 and the second clamp 44. After the external force is removed, the second clamp 44 recovers under the action of elastic force and clamps the leaflet between the first clamp 43 and the second clamp 44. The use principle of the second elastic clip 42 is the same as that of the first elastic clip 41.

[0060] like Figure 6 and Figure 7As shown, the delivery system of the present invention includes two clip control lines 101 and 102. One clip control line 101 is detachably connected to the first elastic clip 41, and the other clip control line 102 is detachably connected to the second elastic clip 42. By lifting the first elastic clip 41 and the second elastic clip 42 upwards through the two clip control lines 101 and 102, the first elastic clip 41 and the second elastic clip 42 can be changed from a closed state to an unfolded state, and then the first support member 12 and the second support member 13 are gradually placed under the leaflet. In the embodiment of the present application, the first inner arm 14 and the second inner arm 15 are positioned below the leaflet, and the two second splints 44 are positioned above the leaflet. Then, through ultrasound imaging, when the leaflet has fallen between the second splint 44 and the corresponding inner arm, the second splint 44 is gradually lowered through the clip control lines 101 and 102 to achieve the capture of the leaflet. If both the anterior and posterior leaflets are captured and clamped, or both the anterior leaflet and the septal leaflet are captured and clamped, at this time, the push wire 103 can be pulled proximally through the delivery system to switch the transcatheter implant device from the captured state to the closed state. Then, the ultrasound image is observed to determine the clamping position and the double hole morphology after clamping. After confirmation, the transcatheter implant device is released in the patient's heart and the delivery system is withdrawn.

[0061] It can be understood that any one of the second clamps 44 will be controlled by the corresponding clamp control line to open relative to the first clamp 43 to capture the valve leaflet. Moreover, during the operation, the two elastic clips can be opened and captured separately to meet the surgical requirements of a single elastic clip clamping operation that may occur during the operation, thereby improving the success rate of the instrument clamping and the effect of transcatheter interventional surgery for the treatment of mitral regurgitation or tricuspid regurgitation.

[0062] To capture the leaflets, each elastic clip is preferably provided with barbs 442, and at least one row of barbs 442 is provided (see Fig. 9 ), a row of barbs 442 are distributed along the circumference of the elastic clip. Fig. 9As shown, in some embodiments, the second clamping plate 44 of each elastic clip includes a bottom plate 441 and a row of barbs 442 arranged on the bottom plate 441. The setting of the barbs 442 improves the puncture effect and puncture depth of the elastic clip, and also improves the stability and reliability of the elastic clip in capturing the leaflets. Preferably, the barbs 442 include a first barb 442a and a second barb 442b, and the length of the first barb 442a is greater than the length of the second barb 442b. Usually, the first barb 442a and the second barb 442b are arranged next to each other. In this way, the setting of long and short barbs increases the fixing points and further improves the stability and reliability of the leaflet clamping. The second clamping plate 44 can be integrally formed, or the bottom plate 441 and the barbs 442 are assembled together after being separately formed. Optionally, the first barb 442a, the second barb 442b and the bottom plate 441 are welded and connected. The first barb 442a and the second barb 442b can be realized by laser cutting and heat setting process. The barbs 442 protrude toward the first clamping plate 43 and can penetrate into the valve leaflet.

[0063] In view of the small contact area between the barbs 442 and the leaflets, the limiting effect is limited. If the barbs 442 are simply provided, the leaflets are easily caught and clamped loosely, which in turn leads to loose edge-to-edge contact after the device is closed, causing recurrence of mitral valve regurgitation or tricuspid valve regurgitation or poor treatment effect. Therefore, the present invention further improves the firmness of the clamping after the leaflets are caught through the movable connection of the connecting member 9, and can be applied to leaflets of different thicknesses and sizes, ensuring the tightness of the edge-to-edge contact after the device is closed, reducing regurgitation and improving the treatment effect.

[0064] Preferably, the position of the barb 442 on the elastic clip is closer to or farther from the central axis of the filling body 11 in the radial direction of the filling body 11 than the position of the connecting piece 9 below the elastic clip, so that the barb 442 and the connecting piece 9 are anchored at different positions on the leaflet to better clamp the leaflet. The elastic clip and the clamping body 51, the connecting piece 9 and the inner arm below it can apply force to the leaflet at multiple points, and these force application points are all distributed at different positions of the same leaflet. When clamping the same leaflet, there can be a variety of point distributions, such as three-point distribution, four-point distribution or more point distribution, especially the diamond point distribution method has a better clamping effect.

[0065] like Figure 1 to Figure 2As shown, the transcatheter implant device of the present invention may also include a joint component, which includes a proximal fixing member 2 and a distal fixing member 3. The proximal fixing member 2 is installed at the proximal end of the filling body 11, and can be used to bind the proximal braided wire or fix the proximal end of the filling member 1, and can also be used to directly or indirectly connect with the push tube of the conveying system. The proximal fixing member 2 and the distal fixing member 3 are both used to be detachably connected with the conveying system. The distal fixing member 3 is installed at the distal end of the support member, and is used to bind the distal braided wire or fix the distal end of the filling member 1, and is also used to directly or indirectly connect with the push wire 103. The proximal end of the first support member 12 is connected to the distal end of the filling body 11, and the distal end of the first support member 12 is connected to the distal fixing member 3, and the second support member 13 connects its proximal end to the distal end of the filling body 11 on the opposite side of the first support member 12, and the distal end of the second support member 13 is connected to the distal fixing member 3, and the first support member 12 and the second support member 13 can be directly or indirectly connected to the distal fixing member 3.

[0066] The proximal fixing member 2 can be connected to the delivery system by any method known in the art, and a commonly used connection method is a snap-fit ​​connection, but it is not limited thereto. Fig.10 As shown in some embodiments, the proximal fixing member 2 is provided with a first clamping head 21 and a second clamping head 22, which are substantially symmetrically arranged along the circumference of the proximal fixing member 2 and extend beyond the edge of the circular base. In this way, the delivery system can be connected to the proximal fixing member 2 by clamping the first clamping head 21 and the second clamping head 22, as shown in FIG. Figure 6 .

[0067] The distal fixing member 3 can also be connected to the delivery system by any method known in the art, and a common connection method is threaded connection, but it is not limited thereto. Figure 1 As shown, in some embodiments, a push wire connector 7 is also installed on the proximal side of the distal fixing member 3, and the push wire connector 7 is used to be directly and releasably connected to the push wire 103. The push wire connector 7 is coaxial with the distal fixing member 3. Optionally, a hollow fixing member 6 is provided in the inner cavity at the bottom (corresponding to the distal end) of the filling body 11, and the fixing member 6 is sleeved on the push wire connector 7, thereby placing the bottom of the filling body 11 on the push wire connector 7, and is also indirectly installed on the distal fixing member 3. When in use, the push wire 103 passes through the proximal fixing member 2, the filling body 11, and the fixing member 6 in sequence, and then passes through the push wire connector 7 and is connected to the push wire connector 7. The proximal fixing member 2 and the fixing member 6 can guide the push wire 103.

[0068] like Fig.10As shown, the proximal fixing member 2 itself has a central through hole 23, through which the push wire 103 can pass. As an example, the distal end of the push wire 103 is threadedly connected to the push wire connector 7, wherein the push wire connector 7 is defined with an internal threaded hole. In this way, the push wire 103 and the clamp control lines 101 and 102 can be used to control the catheter implant device to switch between different states. Exemplarily, the proximal fixing member 2 and the distal fixing member 3 are cut by laser, and the proximal fixing member 2 and the distal fixing member 3 can be connected to the filling component 1 by laser welding or the like.

[0069] like Figure 4 and Fig.11 As shown in some embodiments, a fixing head 52 is provided at the distal end of each clamping body 51, and the fixing head 52 can be inserted into the distal fixing member 3 through the through slot on the push wire connector 7, and is clamped and fixed with the distal fixing member 3. One end of the push wire connector 7 is placed in the through hole in the middle of the fixing member 6, and the other end is connected to the distal fixing member 3.

[0070] The proximal end of the push wire connector 7 is provided with a cylindrical connector, and the distal end is provided with a rectangular connector. The cylindrical connector is covered with a fixing member 6. The inner hole of the cylindrical connector is a threaded hole and is threadedly connected with the push wire 103. The rectangular connector is pressed into the rectangular groove of the distal fixing member 3. The distal fixing member 3 is defined with a rectangular groove, and the two pairs of side edges of the rectangular groove form guide grooves outward, so that the fixing head 52 is inserted into the distal fixing member 3 through the guide groove.

[0071] like Figure 1 , Figures 5 to 8 , Fig.11 As shown, in some embodiments, a cover 8 is provided on the distal side of the distal fixing member 3, and the cover 8 and the distal fixing member 3 are coaxial. The cover 8 can be further connected to the push wire connector 7 to make the connection between the push wire connector 7 and the distal fixing member 3 more stable and reliable. Optionally, the cover 8 is threadedly connected to the internal threaded hole on the push wire connector 7 through a stud with an external thread. The push wire connector 7 and the cover 8 are mainly formed by metal machining. The clamping body 5, the first elastic clip 41 and the second elastic clip 42 are laser cut with nickel-titanium alloy and then heat-set. The fixing member 6 is also mainly realized by machining.

[0072] like Figures 5 to 8 As shown, the transcatheter implantable device of the present invention is also covered by a polymer film 10. Figures 5 to 8The transcatheter implantable devices shown are all coated with a polymer coating 10, which is shown as a filler in the figure. After all mechanical structural parts are installed, all parts assemblies are wrapped with the polymer coating 10. After wrapping, the device can still freely change its shape in the patient's body. The polymer coating 10 can be one-piece or split. Generally, two coating materials are set, one wrapping the filling body 11, and the other one-piece wrapping the support, elastic clip, clamping body 51, distal fixing member 3, and covering member 8. In this way, it is relatively easier to achieve in terms of process.

[0073] Continue to refer to Figures 5 to 8 , and using four clamping bodies 51 as an example, various states of the transcatheter implantation device of the present invention are described in more detail.

[0074] like Figure 5 As shown, in the extended state, the two groups of clamping bodies 51 are close to each other in the radial direction perpendicular to the central axis of the filling component 1, showing a narrowing in the width direction corresponding to the radial direction and a stretching in the length direction corresponding to the axial direction, so that the transcatheter implantable device is in an approximately straightened state, with a small intervention size, which is convenient for transportation in the sheath, and also convenient for timely withdrawal of the device into the atrium when an error is caught during the operation.

[0075] like Figure 6 and Figure 7 As shown, in the capture state, the two groups of clamping bodies 51 are away from each other in the radial direction perpendicular to the central axis of the filling component 1, showing a relaxation in the width direction of the corresponding radial direction and a contraction in the length direction of the corresponding axial direction, so that the transcatheter implant device is in an open state, which is convenient for capturing the valve leaflets at the native valve ring. At this time, the first inner arm 14 and the first outer arm 16 are both in a stable triangular state under the support of the corresponding clamping body 51, and the second inner arm 15 and the second outer arm 17 are also in a stable triangular state under the support of the corresponding clamping body 5, so that the first elastic clip 41 and the second elastic clip 42 can stably and reliably capture the valve leaflets. In the capture state, the angle between the extension direction of the first inner arm 14 and the second inner arm 15 and the predetermined direction can be 90° or less than 90°, and is not limited to extending and opening in the direction perpendicular to the central axis as shown in the figure. The predetermined direction refers to the direction from the distal end to the proximal end along the central axis. During the process of capturing the leaflets, the first elastic clip 41 and the second elastic clip 42 can capture the leaflets individually through two different clip control lines 101 and 102, or they can capture and release them at the same time. This can improve the maneuverability and success rate of leaflet capture. If it is found during the operation that the leaflets on one side are less captured or unstable, adjustments can be made in time to improve the therapeutic effect of the operation.

[0076] After the leaflet is captured, the push wire 103 is controlled to withdraw toward the proximal end, which can pull the distal fixing member 3 toward the proximal end, so that the inner arm moves with the distal fixing member 3 under the force of the clamping body 51 connected thereto, and finally switches from the captured state to the closed state. Figure 8 As shown, in the closed state, the two sets of clamping bodies 51 will pull the first inner arm 14 and the second inner arm 15 toward the center axis due to their own elasticity, and push the barbs 442 of the first elastic clip 41 and the second elastic clip 42 into the leaflet, so that the first elastic clip 41 and the second elastic clip 42 clamp the leaflet more stably and reliably.

[0077] It should be noted that the above embodiment only focuses on describing the implementation method of the delivery system controlling the transcatheter implantable device, and the working principle and other structural components of the delivery system, as well as other auxiliary components of the transcatheter implantable device for valve repair, are not described in detail herein, and those skilled in the art can understand it based on the prior art. It should also be noted that, as discussed herein, the "target tissue" can be a native valve leaflet or a valve leaflet model used for preoperative simulation. In addition, the "patient" or "individual" can be a human or any animal. It should be understood that the animal can be any suitable type, including but not limited to mammals, veterinary animals, livestock animals or pet animals, etc. For example, the animal can be an experimental animal specially selected to have certain characteristics similar to humans (for example, rats, dogs, pigs, monkeys, etc.).

[0078] The above description is only a description of the preferred embodiment of the present invention, and is not intended to limit the scope of the present invention. Any changes or modifications made by a person skilled in the art in the field of the present invention based on the above disclosure shall fall within the scope of protection of the technical solution of the present invention.

Claims

1. A transcatheter implantable device for valve repair, characterized in that: include: A filling component, comprising a filling body and two support members, wherein the two support members are arranged at the distal end of the filling body, each of the support members comprises an inner arm and an outer arm, and the filling body, the inner arm and the outer arm are sequentially connected along the axial direction of the filling body; A capture component, comprising two elastic clips, each of which is connected to a corresponding one of the inner arms; as well as, The clamping component includes a plurality of clamping bodies arranged along the circumference of the filling body, the distal end of each of the clamping bodies being connected to the distal end of the support member, the proximal end of each of the clamping bodies being movably connected to the corresponding inner arm and / or outer arm through at least one connecting member, and any one of the inner arm and / or the outer arm being respectively connected to at least one of the clamping bodies on both sides along the circumference of the filling body.

2. The transcatheter implantable device for valve repair according to claim 1, characterized in that: The proximal end of each of the clamping bodies is movably connected to the corresponding inner arm and / or outer arm via a connecting member.

3. The transcatheter implantable device for valve repair according to claim 2, characterized in that: The connection point between one side of any one of the inner arms and the connecting member and the connection point between the other side of the inner arm and the connecting member are arranged on the same circumference or on different circumferences, and / or, the connection point between one side of any one of the outer arms and the connecting member and the connection point between the other side of the outer arm and the connecting member are arranged on the same circumference or on different circumferences.

4. The transcatheter implantable device for valve repair according to claim 1, characterized in that: One end of the connecting member can be movably mounted on the corresponding eyelet of the inner arm and / or the outer arm, and the other end can be movably mounted on the corresponding connecting hole of the clamping body. Alternatively, the connecting member can be movably inserted into the corresponding inner arm and / or the outer arm and then pass out from one side of the corresponding inner arm and / or the outer arm along the circumferential direction, and then can be movably inserted into and out of the corresponding connecting hole on the clamping body to form a ring.

5. The transcatheter implantation device for valve repair according to claim 4, characterized in that: The connection hole penetrates the clamp body in the thickness direction of the clamp body, and the thickness of the clamp body is the dimension in the direction of clamping the target tissue.

6. The transcatheter implantation device for valve repair according to claim 1 or 4, characterized in that: The connecting piece is a flexible structure or a rigid structure, so that the clamping body can adjust the clamping position and clamping direction.

7. The transcatheter implantation device for valve repair according to claim 1 or 2, characterized in that: There are four clamping bodies, and any one of the inner arms and / or the outer arms is respectively connected to one clamping body on both sides along the circumference of the filling body, and the four clamping bodies are symmetrically arranged in groups of two with respect to the filling body.

8. The transcatheter implantation device for valve repair according to claim 1 or 2, characterized in that: The transcatheter implantation device has at least an extended state, a captured state and a closed state, and can be transformed between these states. In the closed state, any one of the inner arms and / or the outer arms and all the clamps and all the connecting parts connected thereto can surround the target tissue and present a convex shape.

9. The transcatheter implantation device for valve repair according to claim 1 or 2, characterized in that: Each of the elastic clips is provided with at least one row of barbs, the row of barbs being distributed along the circumference of the elastic clip, and the position of the row of barbs being closer to or farther away from the central axis of the filling body in the radial direction of the filling body than the position of the connecting piece below the elastic clip.

10. The transcatheter implantation device for valve repair according to claim 1 or 2, characterized in that: Each of the elastic clips is provided with at least one row of barbs, the row of barbs is distributed along the circumference of the elastic clip, the barbs include first barbs and second barbs, and the length of the first barbs is greater than the length of the second barbs.

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