Transcatheter implantation device for valve repair

Abstract

The application relates to a transcatheter implanting instrument for valve repair, comprising a filling component, two support pieces arranged at the distal end of the filling main body, each of the support pieces 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; a capturing component comprising two elastic clamps, each of the elastic clamps being connected with a corresponding inner arm; and a clamping component comprising a plurality of clamping bodies arranged along the circumferential direction of the filling main body, the distal end of each of the clamping bodies being connected with the distal end of the support piece, the proximal end of each of the clamping bodies being movably connected with the corresponding inner arm and / or outer arm through at least one connecting piece, and each of the inner arms and / or outer arms being connected with at least one clamping body on both sides along the circumferential direction of the filling main body. Thus, the clamping and fastening effect of the instrument on the valve leaflets can be improved, and the instrument can be applied to valve leaflets of different sizes.

Description

Technical Field

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

[0002] The mitral and tricuspid valves are two vital heart valves, acting like check valves. They are crucial cardiac structures that prevent blood from flowing back from the left atrium to the left ventricle or vice versa. Mitral or tricuspid regurgitation occurs when the mitral or tricuspid valves fail to close properly, causing blood to flow backward from the ventricle to the atrium. This backflow can lead to heart failure and severely impact a patient's daily life and work. Mitral or tricuspid regurgitation are the two most common valvular heart diseases, and treatment is relatively complicated and costly, often requiring open-chest surgery, which carries significant risks. Another treatment option for mitral or tricuspid regurgitation is transcatheter interventional minimally invasive surgery. This involves implanting a device into the heart via a catheter delivery system to achieve edge-to-edge repair of the mitral or tricuspid valve leaflets, thereby suppressing the regurgitation and treating the condition.

[0003] Current transcatheter mitral or tricuspid valve implantation devices typically use mechanical or elastic clamps to clamp the mitral or tricuspid valve leaflets to achieve edge-to-edge repair, thereby suppressing mitral or tricuspid regurgitation and achieving the therapeutic effect. The mechanical clamp usually includes a linkage mechanism for transmitting the opening, capture, and locking actions of the implant; a pair of barbed mechanical clamps for capturing, securing, and pulling the leaflets to the center for edge-to-edge, double-hole repair; and a locking mechanism to ensure the implant is closed and locked after edge-to-edge clamping. Elastic clamps differ in structure from mechanical clamps. They primarily consist of an elastic spacer to reduce leaflet stress during clamping and apposition, preventing leaflet tearing; a pair of elastic clamps to capture and pull the leaflets to achieve edge-to-edge, two-hole repair; and a pair of elastic supporting clamps to support the elastic spacer and ensure a tight fit during closure, guaranteeing stable deployment, capture, and closure. Elastic clamps often allow for individual clamp control and capture of each clamp. Furthermore, some clamps employ a double-layer clamping and locking structure, also achieving two-hole repair to suppress mitral or tricuspid regurgitation.

[0004] Mechanical clamps are prone to causing high clamping stress, which can lead to leaflet tearing. Elastic clamps, on the other hand, rely on the elasticity of the elastic element for clamping. However, if the clamping force is inappropriate or irreversible or reversible plastic deformation occurs during operation, the leaflet capture range changes, affecting the leaflet's applicability and the final clamping effect. This impacts the treatment outcome for mitral or tricuspid regurgitation after implantation. Current elastic clamps primarily use barbs for clamping and limiting. These barbs embed into the leaflet, but their small contact area limits their limiting effect, making them prone to leaflet tearing. This can lead to valve tearing or poor edge-to-edge adhesion, increasing the risk of recurrence of mitral or tricuspid regurgitation.

[0005] It should be noted that the information disclosed in the background section of this application is intended only to enhance the understanding of the general background of this application, and should not be construed as an admission or in any way implying that the information constitutes prior art known to those skilled in the art. Summary of the Invention

[0006] The purpose of this invention is to provide a transcatheter implantation device for valve repair, in order to solve the problems of easy tearing of valve leaflets and insecure clamping in existing valve clamping methods.

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

[0008] A filling component includes a filling body and two support members. The two support members are disposed at the distal end of the filling body. Each support member includes an inner arm and an outer arm. The filling body, the inner arm, and the outer arm are connected sequentially along the axial direction of the filling body.

[0009] The capturing component includes two elastic clips, each of which is connected to a corresponding inner arm; and,

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

[0011] In one embodiment, the proximal end of each clamp is movably connected to the corresponding inner arm and / or outer arm via one of the connectors.

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

[0013] In one embodiment, one end of the connector is movably fitted onto the hole of the corresponding inner arm and / or the outer arm, and the other end is movably fitted onto the connecting hole of the corresponding clamping body. Alternatively, the connector can be movably inserted into the corresponding inner arm and / or the outer arm and then exit from one side of the corresponding inner arm and / or the outer arm along the circumferential direction, and then movably inserted into and exited the connecting hole on the corresponding clamping body to form a ring.

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

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

[0016] In one embodiment, there are four clamping bodies, with each inner arm and / or outer arm connected to one clamping body on each side of the circumference of the filling body, and the four clamping bodies are arranged symmetrically about the filling body in pairs.

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

[0018] In one embodiment, the transcatheter implantation device has at least an extended state, a snap-in state, and a closed state, and is capable of switching between these states. In the closed state, any one of the inner arm and / or the outer arm, along with all the clamps and connectors connected to it, can surround the target tissue and present an outwardly convex shape.

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

[0020] As described above, in the transcatheter implantation device for valve repair provided by this invention, several independent clamps elastically support two support members. The inner arm and / or outer arm of each support member are connected to the corresponding clamp. Specifically, the proximal end of each clamp is movably connected to the corresponding inner arm and / or outer arm via at least one connector, rather than being fixedly connected. This movable connection allows for a certain displacement of the clamp and the connected inner arm and / or outer arm, thereby flexibly adjusting the position and orientation of the clamp to the target tissue. In this way, the target tissue (such as leaflet) can be firmly clamped between the clamping body, the inner arm, and the connector. The clamping 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. This makes the applicable leaflet range wider, the leaflet capture more secure, and the leaflet less likely to fall off after capture. This can improve the success rate of device implantation, reduce the risk of implantation failure, and make device implantation safer, more reliable, and more stable. At the same time, it also reduces the operation difficulty 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 helps to suppress mitral or tricuspid regurgitation in patients. Attached Figure Description

[0021] Those skilled in the art will understand that the accompanying drawings are provided to better understand the invention and do not constitute any limitation on the scope of the invention. Wherein:

[0022] Figure 1 This is a cross-sectional view of a catheter implantation device according to an embodiment of the present invention, in which the polymer coating is not shown;

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

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

[0025] Figure 4 This is a cross-sectional view of the entire catheter implantation device according to an embodiment of the present invention;

[0026] Figure 5 This is a schematic diagram of the catheter implantation device in an extended state according to an embodiment of the present invention;

[0027] Figure 6 This is a schematic diagram of the catheter 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 7This is a schematic diagram of the catheter implantation device in a capture state according to an embodiment of the present invention, wherein the clamp control line is not shown;

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

[0030] Figure 9 This is a schematic diagram of the structure of the second clamping plate in an embodiment of the present invention;

[0031] Figure 10 This is a schematic diagram of the proximal fixation component according to an embodiment of the present invention;

[0032] Figure 11 This is an exploded view of the assembly of the clamp, fastener, push wire connector, distal fastener and cover in an embodiment of the present invention.

[0033] In the attached image:

[0034] 1-Filling component; 11-Filling body; 12-First support component; 13-Second support component; 14-First inner arm; 15-Second inner arm; 16-First outer arm; 17-Second outer arm; 2-Proximal fixing component; 21-First clamping head; 22-Second clamping head; 23-Central through hole; 3-Distal fixing component; 4-Catching component; 41-First elastic clamp; 42-Second elastic clamp; 43-First clamping plate; 44-Second clamping plate; 441-Base plate; 442-Barb; 442a-First barb; 442b-Second barb; 5-Clamping component; 51-Clamping body; 6-Fixing component; 7-Push wire connector; 8-Covering component; 9-Connecting component; 10-Polymer coating; 101, 102-Clamping control lines; 103-Push wire. Detailed Implementation

[0035] To make the objectives, advantages, and features of this invention clearer, the invention will be further described in detail below with reference to 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 facilitate and clarify the explanation of the embodiments of this invention. Furthermore, the structures shown in the drawings are often part of the actual structures. In particular, different figures may emphasize different aspects and may sometimes use different scales.

[0036] As used in this invention, the singular forms “a,” “an,” and “the” include plural objects; the term “or” is generally used to mean “and / or”; the term “a number” is generally used to mean “at least one”; and the term “at least two” is generally used to mean “two or more”. Furthermore, the terms “first,” “second,” etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, a feature defined with “first,” “second,” etc., may explicitly or implicitly include one or at least two of that feature. The terms “one end” and “the other end,” and “proximal end” and “remote end” generally refer to two corresponding parts, including not only endpoints. The terms “installed,” “connected,” and “joined” should be interpreted broadly; for example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal connection of two elements or the interaction between two elements. Furthermore, as used in this invention, the phrase "one element is 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 can be direct or indirect through an intermediate element. It should not be construed as indicating or implying a spatial positional relationship between the two elements, i.e., one element can be located arbitrarily inside, outside, above, below, or to one side of the other element, unless otherwise explicitly stated. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0037] In the description of this application, it should be understood that "proximal" and "distal" refer to the positions from the surgeon's perspective during the operation. The direction closer to the surgeon is "proximal," and the direction farther from the surgeon is "distal." In the description of this application, 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 this invention is to provide a transcatheter implantation device (hereinafter referred to as transcatheter implantation device) for valve repair, so as to solve the problems of easy tearing of valve leaflets and weak clamping in existing valve clamping.

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

[0040] The following description refers to the accompanying drawings.

[0041] like Figures 1-3As 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, namely a first support member 12 and a second support member 13. The two support members are located at the distal end of the filling body 11 and connected to it. The support members and the filling body 11 can be integrally formed or separately formed. The filling component 1 is preferably made of woven metal wire or cut metal tubes. As an example, the filling component 1 is integrally woven from nickel-titanium alloy wire, and then its shape is fixed and highly elastic through a heat-setting process. The first support member 12 and the second support member 13 are distributed circumferentially around the filling body 11 on its exterior, typically symmetrically distributed circumferentially.

[0043] Each support member includes an inner arm and an outer arm, which are typically integrally formed, for example, as an integrally formed metal braided structure. 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, as 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. The proximal end of the first inner arm 14 is connected to the distal end of the filling body 11, while the distal end of the first outer arm 16 is typically secured by a connector. The second support member 13 includes a second inner arm 15 and a second outer arm 17, which are connected end-to-end. The proximal end of the second inner arm 15 is connected to the distal end of the filling body 11, while the distal end of the second outer arm 17 is typically secured by the aforementioned connector.

[0044] Furthermore, the capturing component 4 is disposed outside 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. In actual use, a leaflet can be inserted between each elastic clip and the inner arm it is connected to, so that the leaflet is clamped by the inner arm and the elastic clip, and the leaflet is clamped within the elastic clip. Before clamping the leaflet, the elastic clip is opened to capture the leaflet first, and then the inner arm is closed to clamp it. More specifically, the first elastic clip 41 is disposed on the first inner arm 14 and is connected and fixed to the first inner arm 14, for example, by stitching or other means. The second elastic clip 42 is disposed on the second inner arm 15 and is connected and fixed to the second inner arm 15, for example, by stitching or other means. Both the first elastic clip 41 and the second elastic clip 42 are used to capture the leaflet, and both can capture the leaflet individually or simultaneously. Additionally, the filling body 11 can be placed between the leaflets that are edge-to-edge fitted to avoid the risk of leaflet tearing caused by excessive stress when the first elastic clip 41 and the second elastic clip 42, which have elastic support and damping effects, are pulled to the leaflet fitted state.

[0045] Continue to refer to Figures 1 to 3 The clamping component 5 includes a plurality of clamping bodies 51 arranged circumferentially along the filling body 11. There may be four or more clamping bodies 51. Taking four clamping bodies 51 as an example, in this embodiment, every two clamping bodies 51 form a group, forming two groups. The two groups of clamping bodies 51 are connected one-to-one with the two inner arms, that is, each inner arm is connected to only two clamping bodies 51. Furthermore, every two clamping bodies 51 are connected one-to-one with the same inner arm on both sides of the circumferential direction of the filling body 11, thereby forming connection points on both sides of the circumferential direction of each inner arm. Alternatively, the two groups of clamping bodies 51 are connected one-to-one with the two outer arms, so that each outer arm is connected to only two clamping bodies 51, and every two clamping bodies 51 are connected one-to-one with the same outer arm on both sides of the circumferential direction of the filling body 11, thereby forming connection points on both sides of the circumferential direction of each outer arm. Alternatively, at least two clamping bodies 51 may be provided on the same side of the corresponding support member along the circumferential direction, and these clamping bodies 51 may be connected to the inner arm and outer arm of the same support member, respectively. It is also possible that at least two clamping bodies 51 may be provided on the same side of the corresponding support member along the circumferential direction, and these clamping bodies 51 may be connected to either the inner arm or the outer arm of the same support member simultaneously. Multiple clamping bodies 51 on the same side may be arranged overlappingly or side-by-side, thereby increasing the number of positioning points and improving the effect of the clamping bodies 51 in enveloping the positioning leaflet.

[0046] More specifically, the distal end of each clamping body 51 is connected to the distal end of the support member, which is the distal end of the filling component 1. The proximal end of each clamping body 51 is connected to the corresponding inner arm and / or outer arm. In particular, the proximal end of each clamping body 51 is movably connected to the corresponding inner arm and / or outer arm via at least one connector 9, rather than being fixedly connected. Moreover, at least one clamping body 51 is connected to each side of any inner arm along the circumference of the filling body 11, or at least one clamping body 51 is connected to each side of any outer arm along the circumference of the filling body 11, or at least one clamping body 51 is connected to each side of any inner arm and any outer arm along the circumference of the filling body 11. By connecting at least one clamping body 51 to each side of the same support member along the circumference of the filling body 11, the effect of wrapping and positioning the leaflets can be improved. It should also be noted that the clamping body 51 can also be connected at the junction of the inner arm and the outer arm.

[0047] Reference Figure 2In one embodiment, the first inner arm 14 is movably connected to two clamping bodies 51 along both sides of the circumference of the filling body 11 via connectors 9. Similarly, the second inner arm 15 is movably connected to two other clamping bodies 51 along both sides of the circumference of the filling body 11 via connectors 9. The movable connection of the connectors 9 allows for a certain displacement of the clamping bodies 51 and the connected inner and / or outer arms, thereby enabling flexible adjustment of the clamping body 51's position on the clamping leaflets via the connectors 9. Compared to traditional arc-shaped clamping leaflets, this invention increases the force application point through the movable connector 9, which allows the leaflets to be firmly clamped between the clamping body 51, the inner arm (first inner arm 14 or second inner arm 15), and the connector 9. The clamping body 51 can apply force to the inner arm connected to it through the connector 9, effectively pulling the inner arm inward to tighten and clamp the leaflets. This not only makes it applicable to a wider range of leaflets, but also makes the leaflets more firmly captured and less likely to fall off after capture, thereby improving the success rate of device implantation, reducing the risk of implantation failure, and making device implantation safer, more reliable, and more stable. At the same time, it also reduces the difficulty and 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 helps to suppress mitral or tricuspid regurgitation in patients. Understandably, in actual use, the connector 9, inner arm, and clamping body 51 can form a triangular support, allowing them to be at a certain angle. This enables the leaflet to fit more snugly against the outer wall of the leaflet during clamping, while also increasing the leaflet anchoring points. During clamping, the clamping body 51 exerts a certain inward retraction force, with its distal end abutting against the leaflet, thus straightening the connector 9. Part of the leaflet is compressed into the depression formed by the connector 9, inner arm, and clamping body 51, resulting in a more secure leaflet clamping. This method is also suitable for leaflets of different sizes and thicknesses, especially leaflets of different thicknesses. Different leaflet thicknesses can be understood as the leaflet itself having different thicknesses, or different leaflet thicknesses in different patients or individuals. Even with different thicknesses of the same leaflet, the position and angle of the connector 9 can be flexibly adjusted to ensure that the connector 9, clamping body 51, and inner arm fit snugly against the outer wall of the leaflet, guaranteeing a tight clamping effect.

[0048] In the exemplary embodiment shown in the figure, there are four clamping bodies 51, arranged in pairs, symmetrically or asymmetrically installed around the filling body 11. Preferably, the two pairs of clamping bodies 51 are symmetrically installed about the filling body 11, resulting in better clamping and positioning and greater stability. Each clamping body 51 is elastic and is typically made of nickel-titanium alloy through laser cutting and heat setting. The clamping bodies 51 provide elastic support during the operation of the transcatheter implantation device, and when the transcatheter implantation device is in the closed state, they allow the first support member 12 and the second support member 13, which clamp the leaflets, to converge towards the central axis of the filling body 11, making the clamping state of the transcatheter implantation device more stable and reliable when closed.

[0049] The connector 9 selected in this invention can be a rigid structure that is not easily stretched, possessing a certain degree of elasticity and hardness to form a relatively stable anchoring point. In other embodiments, the connector 9 adopts a deformable flexible structure, possessing a certain strength and deformation capacity, and is not easily broken. "Flexible" is relative to "rigid," meaning it is more easily deformed than a rigid structure. In practice, the connector 9 cannot be too soft and should be as unstretchable as possible to ensure stability during clamping and fastening. The connector 9 can take various forms, such as linear, strip-shaped, sheet-shaped, rod-shaped, or tubular structures with a certain degree of elasticity, hardness, and strength. The connector 9 can be made of flexible materials or rigid materials with good elasticity; preferably, it is made of nickel-titanium alloy or a chain-like structure.

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

[0051] like Figure 2 As shown, in one embodiment, the connector 9 is movably inserted into the corresponding inner arm and then exits from one side of the inner arm along the circumferential direction, and then movably inserted into and exits the connecting hole on the clamping body 51 to form a ring. In other embodiments, the connector 9 is movably inserted into the corresponding outer arm and then exits from one side of the outer arm along the circumferential direction, and then movably inserted into and exits the connecting hole on the clamping body 51 to form a ring; or, the connector 9 is simultaneously movably inserted into the corresponding inner arm and outer arm and then exits from one side of the inner arm and outer arm along the circumferential direction, and then movably inserted into and exits the connecting hole on the clamping body 51 to form a ring. Taking a coil as an example, and using the first inner arm 14 as an illustration, the connector 9 is movably inserted into the first inner arm 14 and then exits from one side of the first inner arm 14 along the circumferential direction, and then movably inserted into and exits at least one connecting hole on the proximal end of the clamping body 51 to form a coil, which is free to move. However, the coil is only one exemplary embodiment of the connector 9 of the present invention. The connector 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 clamping body 51 can have one or more connecting holes, but preferably only one. The connecting hole on the clamping body 51 is preferably oriented along the thickness direction of the clamping body 51, which allows for more effective pulling of the inner arm to tighten the leaflets inward. Thus, the connecting hole is provided through the clamping body 51 in the thickness direction, and the thickness of the clamping body 51 is the dimension in the direction of clamping the leaflets; see [reference needed] for details. Figure 2 .

[0053] The proximal end of each clamping body 51 is preferably movably connected to the corresponding inner arm and / or outer arm via a connector 9. This simplifies the structure while still achieving a secure clamping effect. Furthermore, the connection points of one side of any inner arm with the connector 9 and the other side of the same inner arm with the connector 9 can be located on the same circumference or different circumferences, and / or, the connection points of one side of any outer arm with the connector 9 and the other side of the same outer arm with the connector 9 can be located on the same circumference or different circumferences. Preferably, the connection points of the same inner arm and / or the same outer arm on both sides are located on the same circumference, resulting in more even force distribution and a better clamping effect. For example... Figure 2 As shown, in this embodiment, a connector 9 is connected to both sides of the first inner arm 14 along the circumferential direction. The connection points on both sides are basically set on the same circumference, that is, the distance to the central axis of the filling body 11 is 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 allow it to switch between different shapes to meet the requirements of different stages of use. 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, as detailed in [reference needed]. Figures 5 to 8 .

[0055] Figure 5 This illustration shows the extended state of a transcatheter implanted device during delivery within the sheath of a delivery system. The device is then delivered to the atrium (e.g., left or right atrium) via the delivery system, and subsequently released distally from the sheath. After release, the transcatheter implanted device is first transformed into… Figure 8 The closed state is shown, and then it changes from the closed state to... Figure 6 and Figure 7 The captured state is shown. In this captured state, the transcatheter implantation device is inserted between the leaflets, so that the first support 12 and the second support 13 are located below the leaflets. Then, the elastic clip is lowered to capture the leaflets. After successfully capturing the leaflets, the transcatheter implantation device is switched from the captured state to the captured state. Figure 7 The system is then closed (i.e., clamped) as shown, and then the conveyor system is withdrawn.

[0056] Preferably, in the closed state, any inner arm and / or all clamping bodies 51 and all connecting pieces 9 connected to it can surround the leaflet and present an outward convex shape, forming a force application point at the end of each clamping body 51. More specifically, as Figure 3 As shown, when the leaflet is clamped at the connection point of the clamping body 51 and the connector 9, the inner arm, clamping body 51, and connector 9 will adhere to the outer wall of the leaflet. The inner wall of the leaflet is elastically anchored and simultaneously attached to the outer surface of the filling body 11. At this time, due to the flexibility (i.e., mobility) of the connector 9, the inner arm, clamping body 51, and connector 9 will surround the leaflet in a shape such as a convex shape, a wave shape, or other outwardly convex shapes. This method of clamping and wrapping has better reliability and stability, and the clamping is tighter. It should also be noted that... Figure 3 The two dashed lines A in the diagram represent the outlines of the two leaflets after they are surrounded and clamped by the inner arm, clamping body 51, and connecting piece 9, respectively. Each dashed line A represents the clamped state of one leaflet. Thus, the clamping body 51 applies an inward force to the outer wall of the leaflet, which is perpendicular to the leaflet surface and forms a certain angle, less than or equal to 90°. In this way, the force can be perpendicular to or not perpendicular to the leaflet surface to improve the stability of the clamped leaflets and reduce the risk of detachment.

[0057] As described above, the transcatheter implantation device of this invention is applicable to clamping leaflets of different sizes, especially leaflets of different thicknesses. When the leaflets have different sizes or thicknesses, the connector 9, inner arm, and clamping body 51, which fit against the leaflets, can be flexibly adjusted at a certain angle to better fit the leaflets. Even if the leaflets on the left and right sides have different thicknesses, the connector 9 can be flexibly rotated at a certain angle to ensure that the leaflets on both sides are stably fixed. Applying force to different angles or intersection angles of the leaflets can provide a larger and more flexible clamping force, as well as a more accurate limiting effect, increasing the applicability of the transcatheter implantation device and improving the clamping and fastening effect, further improving the success rate of device implantation, making device implantation safer, more reliable, and more stable. At the same time, it can also further reduce the operational difficulty and operation time during the operation, and reduce the risks caused by the device during the operation. Thus, the device has a wide range of applications and good flexibility.

[0058] Reference Figure 1In some embodiments, both the first elastic clip 41 and the second elastic clip 42 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, and the first clamping plate 43 is close to and conforms to the first inner arm 14. 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 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 first elastic clip 41, such that the second clamping plate 44 is subjected to an 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, and the first clamping plate 43 is close to and conforms to the second inner arm 15. 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 subjected to an elastic force toward the first clamping plate 43.

[0059] Taking the first elastic clip 41 as an example, since there is an elastic connection between the second clip 44 and the first clip 43, the second clip 44 is subjected to an elastic force toward the first clip 43, and the first clip 43 is fixed to the first inner arm 14. Therefore, under the action of an external force, the second clip 44 can open relative to the first clip 43. Specifically, an external force is applied to the second clip 44 in a generally proximal direction, causing the second clip 44 and the first clip 43 to open, roughly in a ">" shape, thereby capturing the leaflets and allowing them to enter between the first clip 43 and the second clip 44. After the external force is removed, the second clip 44 returns to its original position under the action of the elastic force, clamping the leaflets between the first clip 43 and the second clip 44. The second elastic clip 42 operates on the same principle as the first elastic clip 41.

[0060] like Figure 6 and Figure 7As shown, the conveying system of the present invention includes two clamp control lines 101 and 102. One clamp control line 101 is detachably connected to the first elastic clamp 41, and the other clamp control line 102 is detachably connected to the second elastic clamp 42. By lifting the first elastic clamp 41 and the second elastic clamp 42 upwards through the two clamp control lines 101 and 102, the first elastic clamp 41 and the second elastic clamp 42 can be changed from a closed state to an open state, thereby gradually placing the first support member 12 and the second support member 13 below the leaflet. In the embodiment of this application, the first inner arm 14 and the second inner arm 15 are positioned below the leaflet, and the two second clamping plates 44 are positioned above the leaflet. By observing through ultrasonic imaging, when the leaflet has fallen between the second clamping plate 44 and the corresponding inner arm, the second clamping plate 44 is gradually lowered through the clamp control lines 101 and 102 to achieve leaflet capture. If both anterior and posterior leaflets are captured and clamped, or if both anterior and septal leaflets are captured and clamped, the delivery system can be used to pull the push wire 103 proximally to switch the transcatheter implantation device from the capture state to the closed state. Then, ultrasound images are observed to determine the clamping position and the double-hole morphology after clamping. Once confirmed to be correct, the transcatheter implantation device is released into the patient's heart, and the delivery system is withdrawn.

[0061] Understandably, any second clip 44 can be manipulated by the corresponding clip control line to open relative to the first clip 43 to capture the leaflet. Moreover, during the operation, the two elastic clips can be opened and captured individually to meet the surgical requirements of single elastic clip clamping operation that may occur during the operation, thereby improving the success rate of instrument clamping and the effect of transcatheter interventional surgery for mitral 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 [reference]). Figure 9 A row of barbs 442 is distributed circumferentially along the elastic clip. For example... Figure 9As shown, in some embodiments, the second clamping plate 44 of each elastic clamp includes a base plate 441 and a row of barbs 442 disposed on the base plate 441. The barbs 442 improve the piercing effect and piercing depth of the elastic clamp, and also improve the stability and reliability of the elastic clamp in capturing the leaflets. Preferably, the barbs 442 include a first barb 442a and a second barb 442b, the length of the first barb 442a is greater than the length of the second barb 442b, and usually, the first barb 442a and the second barb 442b are arranged adjacent to each other. Thus, the arrangement of long and short barbs increases the number of fixing points, further improving the stability and reliability of leaflet clamping. The second clamping plate 44 can be integrally formed, or the base plate 441 and the barbs 442 can be separately formed and then assembled together. Optionally, the first barb 442a, the second barb 442b and the base plate 441 are welded together. The first barb 442a and the second barb 442b can be realized by laser cutting and heat setting processes. The barbs 442 protrude toward the first clamp 43 and can penetrate the petals.

[0063] Given the small contact area between the barbs 442 and the leaflet, their limiting effect is limited. If only the barbs 442 are used, the clamping after capturing the leaflet may not be secure, leading to poor edge-to-edge adhesion after instrument closure. This can cause recurrence of mitral or tricuspid regurgitation or poor treatment outcomes. Therefore, this invention further improves the clamping strength after capturing the leaflet through the movable connection of the connector 9. This allows for application to leaflets of different thicknesses and sizes, ensuring tight edge-to-edge adhesion after instrument closure, reducing regurgitation, and improving treatment efficacy.

[0064] Preferably, the position of the barbs 442 on the elastic clip is closer to or further away from the central axis of the filling body 11 in the radial direction compared to the position of the connector 9 below the elastic clip. This allows the barbs 442 and the connector 9 to be anchored at different positions on the leaflet for better clamping of the leaflet. The elastic clip, along with the clamping body 51 below it, the connector 9, and the inner arm, can apply force to the leaflet at multiple points. These force application points are distributed at different positions on the same leaflet, allowing for various point distributions when clamping the same leaflet, such as three-point, four-point, or more point distributions. In particular, a diamond-shaped point distribution provides a better clamping effect.

[0065] like Figures 1 to 2As shown, the transcatheter implantation device of the present invention may further include a connector component, which includes a proximal fixation member 2 and a distal fixation member 3. The proximal fixation member 2 is installed at the proximal end of the filling body 11, and can be used to restrain the proximal braided wire or fix the proximal end of the filling component 1, and can also be used to connect directly or indirectly to the delivery tube of the delivery system. Both the proximal fixation member 2 and the distal fixation member 3 are used for detachable connection to the delivery system. The distal fixation member 3 is installed at the distal end of the support member, and is used to restrain the distal braided wire or fix the distal end of the filling component 1, and also for direct or indirect connection to the delivery 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 fixation member 3. 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 fixation member 3. The first support member 12 and the second support member 13 can be directly or indirectly connected to the distal fixation member 3.

[0066] The proximal fastener 2 can be connected to the conveying system in any manner known in the art, with a commonly used snap-fit ​​connection being a common method, but it is not limited to this. For example... Figure 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. The first clamping head 21 and the second clamping head 22 are arranged substantially symmetrically along the circumference of the proximal fixing member 2 and extend beyond the edge of the circular base. Thus, the conveying system can connect to the proximal fixing member 2 by clamping the first clamping head 21 and the second clamping head 22. (See also...) Figure 6 .

[0067] The remote fixing component 3 can also be connected to the conveying system in any manner known in the art, with threaded connection being a common method, but not limited to this. (See reference...) Figure 1 As shown, in some embodiments, a push wire connector 7 is also installed proximally to the distal fixing member 3. The push wire connector 7 is used for direct and detachable connection with 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 of the bottom (corresponding to the distal end) of the filling body 11. 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 thus indirectly mounting it on the distal fixing member 3. 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 connects with the push wire connector 7. The proximal fixing member 2 and the fixing member 6 can guide the push wire 103.

[0068] like Figure 10As shown, the proximal fixation member 2 has a central through hole 23 through which the push wire 103 passes. As an example, the distal end of the push wire 103 is threadedly connected to a push wire connector 7, which defines an internally threaded hole. Thus, the transcatheter implantation device can be manipulated to switch between different states through the cooperation of the push wire 103 and the clamp control lines 101 and 102. Exemplarily, the proximal fixation member 2 and the distal fixation member 3 are laser-cut, and can be connected to the filling component 1 by laser welding or other methods.

[0069] like Figure 4 and Figure 11 As shown, in some embodiments, each clamping body 51 has a fixing head 52 at its distal end. The fixing head 52 can be inserted into the distal fixing member 3 through a through groove on the push wire connector 7 and is snapped and fixed to 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 push wire connector 7 has a cylindrical connector at its proximal end and a rectangular connector at its distal end. The cylindrical connector is fitted with a fixing member 6. The inner hole of the cylindrical connector is a threaded hole and is threadedly connected to the push wire 103. The rectangular connector is pressed into the rectangular groove of the distal fixing member 3. The distal fixing member 3 defines a rectangular groove, and the two opposite 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 grooves.

[0071] like Figure 1 , Figures 5-8 , Figure 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 by a stud with external threads. The push wire connector 7 and the cover 8 are mainly formed by metal machining. The clamping body 5, the first elastic clamp 41 and the second elastic clamp 42 are made by laser cutting of nickel-titanium alloy and then heat setting. The fixing member 6 is also mainly formed by machining.

[0072] like Figures 5 to 8 As shown, the catheter-implantable device of the present invention is further coated with a polymer membrane 10. Figures 5 to 8The transcatheter implantable devices shown are all covered with a polymer membrane 10, which serves as the filler material in the figure. After all mechanical components are installed, the polymer membrane 10 encapsulates all the assembled parts, allowing the device to freely change shape within the patient's body. The polymer membrane 10 can be one-piece or two-piece, typically using two membrane materials: one to encapsulate the filler body 11, and the other one-piece to encapsulate the support, elastic clip, clamping body 51, distal fixation component 3, and cover 8. This design is relatively easier to implement in terms of manufacturing process.

[0073] The following continues to refer to... Figures 5 to 8 The various states of the transcatheter implantation device of the present invention are illustrated in more detail using four clamping bodies 51 as examples.

[0074] like Figure 5 As shown, in the extended state, the two sets of clamps 51 approach each other radially in a direction perpendicular to the central axis of the filling component 1, exhibiting a narrowing in the width direction corresponding to the radial direction and an extension in the length direction corresponding to the axial direction, so that the catheter-implanted device is in an approximately straightened state, with a small intervention size, which facilitates delivery within the sheath and also facilitates timely withdrawal of the device into the atrium in case of intraoperative errors.

[0075] like Figure 6 and Figure 7 As shown, in the capture state, the two sets of clamping bodies 51 are radially separated from each other in a direction perpendicular to the central axis of the filling component 1, exhibiting a widening in the corresponding radial width direction and a contraction in the corresponding axial length direction, thus placing the transcatheter implantation instrument in an open state to facilitate capture of the leaflet at the original valve annulus. 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 bodies 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 bodies 51. This facilitates the stable and reliable capture of the leaflet by the first elastic clamp 41 and the second elastic clamp 42. 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, and is not limited to the direction perpendicular to the central axis shown in the figure. The predetermined direction refers to the direction along the central axis from the distal end to the proximal end. During the leaflet capture process, 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 capture and release them simultaneously. This can improve the maneuverability and success rate of leaflet capture. If it is found during the operation that one side of the leaflets is captured less or is unstable, adjustments can be made in time to improve the treatment effect of the operation.

[0076] After capturing the leaflets, manipulating the push wire 103 to retract proximally pulls the distal fixing member 3 proximally, causing the inner arm to move along with the distal fixing member 3 under the force of the clamping body 51 connected to it, finally transitioning 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 central axis due to their own elasticity, and push the barbs 442 of the first elastic clamp 41 and the second elastic clamp 42 to squeeze into the leaflet, so that the first elastic clamp 41 and the second elastic clamp 42 clamp the leaflet more stably and reliably.

[0077] It should be noted that the above embodiment focuses only on describing the implementation of the transcatheter implantation device controlled by the delivery system. The working principle of the delivery system and other structural components, as well as other auxiliary components of the transcatheter implantation device for valve repair, will not be described in detail here; those skilled in the art can understand them based on existing technology. It should also be noted that, as discussed herein, the "target tissue" can be the original valve leaflet or a valve leaflet model used for preoperative simulation. Furthermore, the "patient" or "individual" can be a human or any animal. It should be understood that the animal can be any applicable type, including but not limited to mammals, veterinary animals, livestock, or pets. For example, the animal can be a laboratory animal specifically selected to have certain characteristics similar to humans (e.g., rats, dogs, pigs, monkeys, etc.).

[0078] The above description is only a description of preferred embodiments of the present invention and is not intended to limit the scope of the present invention in any way. Any changes or modifications made by those skilled in the art based on the above disclosure shall fall within the protection scope of the present invention.

Claims

1. A transcatheter implantable device for valve repair, characterized in that, include: A filling component includes a filling body and two support members. The two support members are disposed at the distal end of the filling body. Each support member includes an inner arm and an outer arm. The filling body, the inner arm, and the outer arm are connected sequentially along the axial direction of the filling body. The capturing component includes two elastic clips, each of which is connected to a corresponding inner arm; as well as, The clamping component includes a plurality of clamping bodies arranged circumferentially along the filling body, the distal end of each clamping body being connected to the distal end of the support member, and the proximal end of each clamping body being movably connected to the corresponding inner arm and / or outer arm via at least one connector, and at least one clamping body being connected to each of the inner arm and / or outer arm on both sides of the filling body along the circumferential direction. The connector is a flexible or rigid structure, which allows the clamping body to adjust the clamping position and clamping direction; and in the closed state, any one of the inner arm and / or the outer arm and all the clamping bodies and all the connectors connected to it can surround the target tissue and present an outward convex shape.

2. The transcatheter implantable device for valve repair according to claim 1, characterized in that, The proximal end of each clamp is movably connected to the corresponding inner arm and / or outer arm via one of the connectors.

3. The transcatheter implantable device for valve repair according to claim 2, characterized in that, The connection point of one side of any inner arm to the connector and the connection point of the other side of the inner arm to the connector are located on the same circumference or on different circumferences, and / or, the connection point of one side of any outer arm to the connector and the connection point of the other side of the outer arm to the connector are located 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 connector is movably fitted onto the hole of the corresponding inner arm and / or the outer arm, and the other end is movably fitted onto the connecting hole of the corresponding clamping body. Alternatively, the connector can be movably inserted into the corresponding inner arm and / or the outer arm and then exit from one side of the corresponding inner arm and / or the outer arm along the circumferential direction, and then movably inserted into and exited the connecting hole on the corresponding clamping body to form a ring.

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

6. The transcatheter implantable device for valve repair according to claim 1 or 2, characterized in that, There are four clamping bodies. Each of the inner arm and / or outer arm is connected to one clamping body on each side of the circumference of the filling body. The four clamping bodies are arranged symmetrically about the filling body in pairs.

7. The transcatheter implantable device for valve repair according to claim 1 or 2, characterized in that, The transcatheter implantation device has at least an extended state, a snap-in state, and a closed state, and is capable of switching between these states.

8. The transcatheter implantable 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 circumferentially along the elastic clip, and the position of the row of barbs being closer to or further away from the central axis of the filling body in the radial direction of the filling body compared to the position of the connector below the elastic clip.

9. The transcatheter implantable 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 circumferentially along the elastic clip, the barbs including a first barb and a second barb, the length of the first barb being greater than the length of the second barb.

Images