Transcatheter heart valve repair assembly and system

Abstract

The invention relates to a transcatheter heart valve repair assembly and system. The transcatheter heart valve repair assembly comprises a fishing ring and a plugging frame. The fishing ring is spiral, can be axially compressed and is used for being wound outside the valve chordae tendineae; the plugging frame can be switched between a radial collapsing structure and a radial expanding structure, and the plugging frame is sequentially provided with a skirt edge part, a main body part and a connecting part from the blood inflow end to the blood outflow end; the skirt edge part extends outwards in the radial direction and is used for being attached to the side wall of the atrium and sealing the valve opening. The main body part is in a hollow cylinder shape and is connected with the small-diameter end of the skirt part; the connecting part comprises a connecting arm, the connecting arm is folded from the blood outflow end to the blood inflow end, and the radial inner side of the connecting arm is used for being connected with or abutting against the fishing ring; axial pre-tightening force can be formed between the fishing ring and the plugging frame through cooperation of the connecting arms and the fishing ring, and the axial pre-tightening force is used for enabling the skirt edge part to be attached to the side wall of the atrium in a sealed mode and conducting axial positioning on the fishing ring.

Description

Technical Field

[0001] The present invention relates to the field of medical devices for cardiac surgery, and particularly to a transcatheter cardiac valve repair assembly and system. Background Art

[0002] Mitral regurgitation is a common cardiac valve disease, which is mainly manifested as mitral insufficiency leading to blood reflux. The current treatment methods mainly include two approaches: surgical treatment and transcatheter interventional treatment.

[0003] In traditional surgical operations, doctors usually use a valve annuloplasty ring to repair the mitral valve. The annuloplasty ring can effectively reshape the dilated annulus, reduce the orifice area, and thus improve the valve function. However, open-chest surgery has large trauma and a long recovery period, and not all patients are suitable for open-chest surgery.

[0004] In recent years, transcatheter cardiac valve repair technology has gradually become an important option for the treatment of mitral regurgitation. Currently, the edge-to-edge repair technology is widely used clinically, that is, the anterior and posterior leaflets are clamped together by a special clip. Although this method has less trauma, the operation difficulty is relatively large because it is necessary to accurately clamp the moving leaflets under the condition of a beating heart; more importantly, when the repair device fails after long-term implantation, it is often difficult to perform subsequent transcatheter treatment.

[0005] On the other hand, although transcatheter implantation of an annuloplasty ring is an ideal treatment option, there are currently few related devices, mainly because there are two key technical difficulties in the transcatheter implanted annuloplasty ring: firstly, it is difficult to stably fix the annuloplasty ring at the annulus after transcatheter implantation, and it is easy to shift; secondly, it is difficult for the annuloplasty ring to closely fit the annulus, which may lead to paravalvular leakage and residual regurgitation, affecting the treatment effect. Summary of the Invention

[0006] The present invention discloses a transcatheter cardiac valve repair assembly and system, aiming to solve the technical problems existing in the prior art.

[0007] The present invention adopts the following technical solutions:

[0008] On the one hand, an embodiment of the present invention provides a transcatheter cardiac valve repair assembly, including a capture ring and a sealing frame;

[0009] The capture ring is spiral and can be axially compressed, and is used for coiling outside the valve chordae tendineae plexus;

[0010] The sealing frame can be converted between a radially collapsed structure and a radially expanded structure. The sealing frame is sequentially provided with a skirt portion, a main body portion, and a connecting portion from the blood inflow end to the blood outflow end;

[0011] The skirt portion extends radially outward and is used for fitting the atrial side wall and sealing the valve orifice;

[0012] The main body part is in a hollow cylindrical shape and is connected to the small-diameter end of the skirt part;

[0013] The connecting part includes a connecting arm which is folded from the blood outflow end towards the blood inflow end, and the radially inner side of the connecting arm is used for connecting or abutting against the fishing ring;

[0014] The cooperation between the connecting arm and the fishing ring can form an axial pre-tightening force between the fishing ring and the blocking frame, and the axial pre-tightening force is used to make the skirt part fit tightly with the atrial side wall and axially position the fishing ring.

[0015] As a preferred technical solution, the fishing ring has a natural state and a compressed state. The height of the fishing ring in the fully compressed state is less than its height in the natural state, and the height of the main body part is between the natural state height and the compressed state height of the fishing ring. The height difference between the fishing ring and the main body part is used to generate axial compressive deformation and maintain the axial pre-tightening force.

[0016] As a preferred technical solution, the inner diameter of the fishing ring in the natural state is less than the outer diameter of the main body part in the radially expanded structure, and their radial cooperation is used to make the fishing ring fit tightly with the main body part to form a circumferential seal.

[0017] As a preferred technical solution, the connecting part is provided with two connecting arms, and the set positions of the two connecting arms match the gaps in the autologous valve leaf junction area, so that the connecting arms can pass outwards from the gaps in the autologous valve leaf junction area.

[0018] As a preferred technical solution, each connecting arm includes at least one support rod. One end of the support rod is connected to the main body part, and the other end extends radially outwards and obliquely;

[0019] The structure of the support rod is configured as one or a combination of more than one of a straight line shape, an S shape, an arc shape, a ring shape, a wavy shape or a spiral shape.

[0020] As a preferred technical solution, the connecting arm includes two support rods, and the two support rods are arranged in contact with each other along their extending directions, or are arranged separately in at least some sections along their extending directions.

[0021] As a preferred technical solution, the two support rods are connected at the ends far from the main body part, and the connection point of the two support rods and the side wall of the main body part form a triangular support structure.

[0022] As a preferred technical solution, the included angle between the connecting arm and the main body part is 0° to 60°.

[0023] As a preferred technical solution, the connecting arm is provided with a barb part at the end far from the main body part, and the barb part extends radially towards the main body part.

[0024] As a preferred technical solution, a triangular structure is formed among the barb portion, the side wall of the main body portion, and the connecting arm for the fishing ring to pass through.

[0025] As a preferred technical solution, an arc chamfer is provided at the connection area between the connecting arm and the main body portion, and the inner diameter of the arc of the arc chamfer is not less than the cross-sectional diameter of the coil of the fishing ring.

[0026] As a preferred technical solution, a sealing film is provided on the outer side of the main body portion, and the sealing film includes materials such as PET, ePTFE, bovine pericardium, or porcine pericardium.

[0027] As a preferred technical solution, the sealing film is arranged in a double layer locally on the main body portion on both sides of the connecting arm.

[0028] On the other hand, an embodiment of the present invention further provides a transcatheter heart valve repair system, including the transcatheter heart valve repair component described in any one of the above, and further including a first delivery device and a second delivery device;

[0029] The first delivery device is used to connect and deliver the fishing ring through a vascular access.

[0030] The second delivery device is used to connect and deliver the occluder through a vascular access.

[0031] The technical solution adopted by the present invention can achieve the following beneficial effects:

[0032] The present invention provides a transcatheter heart valve repair component and system. Among them, the transcatheter heart valve repair component includes a fishing ring and an occluder. The fishing ring adopts an open-ring structure and has compression performance in the vertical direction. Through the height difference design with the main body portion of the occluder, an axial pre-tightening force can be formed between the implanted fishing ring and the occluder, so as to prompt the skirt portion of the occluder to closely fit with the atrial side wall, effectively solve the problems of paravalvular leakage and regurgitation, and at the same time, the fishing ring can be fixed below the valve annulus to ensure the position stability of the entire component.

[0033] Furthermore, the occluder further has two connecting arms. The connecting arms can penetrate into the gap in the area of the autologous valve leaf junction and be connected to the fishing ring. The connecting arms can be formed by connecting two support rods and form a triangular support structure with the side wall of the main body portion. It can not only increase the contact area with the fishing ring, making the cooperation between the two more stable, but also prevent the connecting arms from being twisted or folded during the delivery in the delivery device, and at the same time prevent lateral deflection after release and after contacting the fishing ring. A barb portion can be further provided at the end of the connecting arm, and the barb portion extends radially towards the main body portion. At this time, a triangular space for the fishing ring to pass through can be formed among the barb portion, the connecting arm, and the side wall of the main body portion, increasing the stability of the connecting arm after hooking the fishing ring.

[0034] In view of the problem of possible chordae tendineae injury caused by long-term implantation of components, in the embodiments of the present invention, a sealing film is specially provided on the outer side of the main body of the occlusion frame, and a double-layer sealing film design is adopted in key areas, especially in the areas on both circumferential sides of the connecting arm, so as to enhance the buffering performance and avoid the chordae tendineae where the occlusion frame and the fishing ring are squeezed and rubbed intensively.

[0035] The embodiments of the present invention further provide a transcatheter heart valve repair system, including a transcatheter heart valve repair component, a first delivery device, and a second delivery device. Among them, the first delivery device is used to connect and deliver the fishing ring through a vascular access, and the second delivery device is used to connect and deliver the occlusion frame through a vascular access. Through this solution of double delivery devices, the fishing ring and the occlusion frame can be implanted in stages, which can effectively reduce the profile value of the delivery device, reduce the delivery difficulty, and reduce the harm to the patient's blood vessels. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following will briefly introduce the drawings required for the description of the embodiments, which form a part of the present invention. The schematic embodiments of the present invention and their descriptions explain the present invention and do not constitute an improper limitation to the present invention. In the drawings:

[0037] Figure 1 It is a schematic structural diagram of the fishing ring in a natural state in an embodiment of Embodiment 1 of the present invention;

[0038] Figure 2 It is a schematic structural diagram of the fishing ring in a compressed state in an embodiment of Embodiment 1 of the present invention;

[0039] Figure 3 It is a schematic structural diagram of the occlusion frame in an embodiment of Embodiment 1 of the present invention;

[0040] Figure 4 It is a schematic diagram of the structural cooperation between the fishing ring and the occlusion frame in an embodiment of Embodiment 1 of the present invention;

[0041] Figure 5 It is a top view of the occlusion frame in an embodiment of Embodiment 1 of the present invention;

[0042] Figure 6 It is a front view of the occlusion frame in an embodiment of Embodiment 1 of the present invention;

[0043] Figure 7 It is a schematic structural diagram of the connecting arm in an embodiment of Embodiment 1 of the present invention;

[0044] Figure 8 It is a schematic structural diagram of the connecting arm in an embodiment of Embodiment 1 of the present invention;

[0045] Figure 9 Schematic diagram of the structure of the connecting arm in an implementation manner of Embodiment 1 of the present invention;

[0046] Figure 10 Schematic diagram of the structure of the connecting arm in an implementation manner of Embodiment 1 of the present invention;

[0047] Figure 11 Schematic diagram of the structure of the connecting arm in an implementation manner of Embodiment 1 of the present invention;

[0048] Figure 12 is Figure 11 Schematic diagram of the connecting arm in [] applied to the plugging frame;

[0049] Figure 13 Schematic diagram of the structure of the connecting arm in an implementation manner of Embodiment 1 of the present invention;

[0050] Figure 14 is Figure 13 Schematic diagram of the connecting arm in [] applied to the plugging frame;

[0051] Figure 15 Schematic diagram of the structural cooperation between the fishing ring and the plugging frame in an implementation manner of Embodiment 1 of the present invention;

[0052] Figure 16 Schematic diagram of the deformation of the plugging frame when subjected to axial pressure in an implementation manner of Embodiment 1 of the present invention;

[0053] Figure 17 Schematic diagram of the deformation of the plugging frame when subjected to axial pressure in another implementation manner of Embodiment 1 of the present invention;

[0054] Figure 18 Schematic diagram of the flat structure of the plugging frame in an implementation manner of Embodiment 1 of the present invention;

[0055] Figure 19 Bottom view of the structural cooperation between the fishing ring and the main body of the plugging frame in an implementation manner of Embodiment 1 of the present invention;

[0056] Figure 20 Bottom view of the structural cooperation between the fishing ring and the main body of the plugging frame during the working process in an implementation manner of Embodiment 1 of the present invention;

[0057] Figure 21 — Figure 26 Schematic diagram of the release process of the plugging frame in an implementation manner of Embodiment 1 of the present invention;

[0058] Figure 27 — Figure 32 Schematic diagram of the working process of the transcatheter heart valve repair system in an implementation manner of Embodiment 2 of the present invention.

[0059] Description of the reference numerals:

[0060] Fishing ring 10, blocking frame 20, skirt part 21, main body part 22, connecting arm 23, support rod 231, barb part 232, sealing film 30, double-layer sealing film 31, chordae tendineae 40, valve leaflet 50, catheter 60. Detailed implementation manners

[0061] In order to make the objectives, technical solutions and advantages of the present invention clearer, the technical solutions of the present invention will be clearly and completely described below in conjunction with specific embodiments of the present invention and the corresponding drawings. In the description of the present invention, it should be noted that the term "or" is generally used in the sense of including "and / or", unless otherwise clearly specified in the content.

[0062] In the description of the present invention, it should be noted that unless otherwise clearly specified and limited, the terms "installation", "connection" and "connection" should be understood in a broad sense. For example, it may be a fixed connection, a detachable connection or an integral connection; it may be a mechanical connection or an electrical connection; it may be directly connected or indirectly connected through an intermediate medium, and it may be the communication inside two components. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific situations. In addition, in the description of this application, the terms "first", "second", etc. are only used for distinguishing descriptions and cannot be understood as indicating or implying relative importance. As used herein, "proximal end" refers to the end close to the operator along the length direction of the delivery device, and the "distal end" is the end far from the operator along the length direction of the delivery device.

[0063] Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0064] Example 1

[0065] In the existing treatment schemes for mitral regurgitation, although the edge-to-edge clamping technique has less trauma, it is difficult to accurately clamp the moving valve leaflets under the condition of a beating heart, and it is difficult to perform subsequent transcatheter treatment after the long-term implantation of the instrument fails; while the transcatheter implantation of the forming ring is an ideal scheme, but the forming ring is difficult to be stably fixed at the valve annulus and it is difficult to closely fit with the valve annulus, so paravalvular leakage and residual regurgitation may occur.

[0066] To solve the problems existing in the prior art, the embodiments of the present invention provide a transcatheter heart valve repair assembly, refer to Figure 1 — Figure 4, the component includes a capture ring 10 and a sealing frame 20. Among them, the capture ring 10 is first implanted during transcatheter valve repair. It can be spirally coiled outside the chordae tendineae of the valve, thereby reducing the enlarged mitral valve orifice of the patient due to the disease; the sealing frame 20 is implanted after the capture ring 10 is implanted. The main purpose of its design is to cooperate with the capture ring 10 to fix its position, so as to achieve effective sealing of the orifice, further avoid blood reflux, and solve the problem of paravalvular leakage that may be caused by simply implanting the capture ring 10.

[0067] Such as Figure 1 , Figure 2 , in some embodiments, the capture ring 10 is configured as a spiral open-loop multi-turn coil, preferably made of a shape memory metal material. After release, it can be coiled around the chordae tendineae of the mitral valve and can be axially compressed. Specifically, the capture ring 10 can be straightened and accommodated in the delivery device in the delivery state. When it reaches the target position and is released, due to its material properties and structural design, it can automatically return to the preset spiral state. Through this spiral structure, the capture ring 10 can effectively wind around the outer periphery of the chordae tendineae of the mitral valve, thereby realizing the contraction of the enlarged orifice. At the same time, the design of the spiral structure gives it a certain degree of compressibility, which can adapt to the dynamic changes of the valve during the heartbeat and reduce the risk of damage to the chordae tendineae 40.

[0068] In some embodiments, to improve the biocompatibility and mechanical properties between the capture ring 10 and the chordae tendineae, at least one layer of biocompatible layer can be further provided on the outer surface of the capture ring 10. The biocompatible layer can be made of a soft biocompatible material, such as PET film, ePTFE film, PU film, etc. By adding the biocompatible layer, on the one hand, the friction coefficient between the capture ring 10 and the chordae tendineae can be increased, improving the fixing stability of the device and preventing the capture ring 10 from undergoing unexpected axial displacement after implantation. On the other hand, it can reduce the mechanical stimulation of the capture ring 10 on the chordae tendineae 40 tissue, reduce tissue damage and inflammatory reactions, and is beneficial to its long-term implantation effect.

[0069] In some embodiments, the capture ring 10 has a natural state and a compressed state after release. The height in the natural state is L1, the inner diameter is D1, and the height in the fully compressed state is L2, where L1 > L2; in this embodiment, only the height relationship between the natural state and the compressed state of the capture ring 10 is defined, and the specific height values are no longer limited. Those skilled in the art can select or adjust the actual height values according to needs. It should be noted that the above natural state refers to the spiral structure state of the capture ring 10 after being released in the heart; the compressed state refers to a more compact spiral structure state formed by being further axially compressed under the spiral structure, rather than the straight structure state during delivery.

[0070] Due to the relatively large space in the sub-valvular chamber of the mitral valve, there may be a risk of longitudinal displacement when using the capture ring 10 alone. Specifically, after implantation, the capture ring 10 may shift towards the apex due to gravity and cardiac movement, and eventually fall to the papillary muscle, resulting in its inability to effectively tighten the valve annulus, thereby affecting the treatment effect. For this reason, the occluder 20 is subsequently implanted and used in conjunction with the capture ring 10 to prevent the capture ring 10 from moving axially and ensure its stable fixation at the target position, so as to achieve or further enhance the expected treatment effect.

[0071] In some embodiments, the occluder 20 is preferably made of a shape memory alloy material, such as nitinol, and its overall structure can be converted between a radially collapsed configuration and a radially expanded configuration. It is in a collapsed configuration during delivery and in an expanded configuration after being released in the heart.

[0072] Such as Figure 3 , in some embodiments, one end of the occluder 20 is the blood inflow end, corresponding to the atrial side, and the other end is the blood outflow end, corresponding to the valve annulus side. The occluder 20 is successively provided with a skirt portion 21, a main body portion 22 and a connecting portion from the blood inflow end to the outflow end; wherein, the skirt portion 21 extends radially outward in a flange shape for fitting against the atrial side wall and sealing the valve orifice, the main body portion 22 is in a hollow cylindrical shape and is connected to the small diameter end of the skirt portion 21, and the connecting portion is further provided with a connecting arm 23. The connecting arm 23 is folded from the blood outflow end to the blood inflow end, and the radially inner side of the connecting arm 23 is used for connecting or abutting against the capture ring 10; the cooperation between the connecting arm 23 and the capture ring 10 can form an axial pre-tightening force between the capture ring 10 and the occluder 20, and the axial pre-tightening force is used to make the skirt portion 21 fit tightly against the atrial side wall and axially position the capture ring 10.

[0073] In some embodiments, the skirt portion 21 includes several diamond grid supports and elastic connectors. One end of the diamond grid support is connected to the main body portion 22 through an elastic connector, and the other end can be releasably connected to the corresponding delivery device during delivery; the skirt portion 21 expands radially outward after being released, and the projected area after expansion is preferably larger than the diameter of the valve orifice to ensure complete coverage of the valve orifice and prevent paravalvular leakage; after the connecting arm 23 is connected or abutted against the capture ring 10, the capture ring 10 will pull the entire assembly downward in the axial direction, causing the skirt portion 21 to further closely adhere to the atrial side wall to further enhance the effect of preventing paravalvular leakage.

[0074] In some embodiments, the main body portion 22 includes one to several rows of polygonal grid structures, and adjacent grid structures are connected by wave bars or nodes with certain elasticity. Among them, the polygonal grid is preferably a rhombus, and pentagons, hexagons and other units that can form a closed shape can also be selected.

[0075] Such as Figure 3 、 Figure 4, in some embodiments, in the state where the occluder frame 20 is fully released, the axial height of the main body portion 22 is L3. Compared with the dimensional parameters of the capture ring 10, L1 > L3 > L2. This height difference causes the capture ring 10 to be in a compressed state axially when the capture ring 10 and the occluder frame 20 are fully released and used in combination, and generates the above-mentioned axial pre-tightening force. This axial pre-tightening force can not only ensure the stable connection between the capture ring 10 and the occluder frame 20 and fix them at the patient's valve annulus, but also make the skirt portion 21 of the occluder frame 20 closely fit the atrial side wall, effectively avoiding the complications of postoperative regurgitation and paravalvular leakage.

[0076] In some embodiments, in the state where the occluder frame 20 is fully released, the outer diameter of the main body portion 22 is D2. Compared with the dimensional parameters of the capture ring 10, D2 is slightly larger than D1, so that there is no clearance fit between them in the radial direction after release, forming a circumferential sealing clamp on the valve leaflets 50 and further preventing the occurrence of paravalvular leakage.

[0077] In some embodiments, the connecting portion is provided with two connecting arms 23. The connecting arms 23 can be symmetrically or asymmetrically distributed about the center. When the occluder frame 20 is released, the connecting arms 23 extend radially outward and penetrate into the coil gaps of the capture ring 10 to connect with it, or the connecting arms 23 extend outward from the bottom of the capture ring 10 and abut against it to support the entire capture ring 10.

[0078] As Figure 5 , in some embodiments, since the mitral valve leaflets 50 of a human are not completely symmetrical, and the two junctions of the anterior leaf and the posterior leaf (i.e., the intersections of A1P1 and A3P3 in the mitral valve anatomical structure) form a certain angle. Therefore, the distribution positions of the two connecting arms 23 are preferably matched with the gaps in the junction area of the autologous valve leaflets 50, so that the connecting arms 23 can penetrate outward from the gaps in the junction area of the autologous valve leaflets 50 and connect or abut against the capture ring 10. At this time, the presence of the connecting arms 23 will not block the opening and closing movement of the patient's autologous valve leaflets 50, thus avoiding the patient losing the function of the mitral valve during the operation, resulting in a large amount of regurgitation and endangering life.

[0079] In some embodiments, a first preset angle α1 is provided between the central extension lines of the two connecting arms 23, 160° ≤ α1 ≤ 180°. This angle is matched with the natural angle formed by the anterior and posterior leaflets of the mitral valve at the junction, and can be set according to the angles of the valve leaflet junction areas of different patients to ensure that the connecting arms 23 can penetrate from the gaps in the junction area of the valve leaflets 50 without affecting the normal movement function of the valve leaflets 50.

[0080] Specifically, the central extension line of the connecting arm 23 refers to an imaginary line formed by extending the axial center line of the projection of the connecting arm 23 on the horizontal plane, and this extension line passes through the axis of the blocking frame 20. Herein, the aforementioned horizontal plane is the plane where the bottom surface of the blocking frame 20 is located, and the axis is the center of the bottom surface projection. Structurally, although each connecting arm 23 is an elongated member, it may actually have a certain inclination angle in space. Therefore, it is necessary to project it onto the horizontal plane, and draw a straight line passing through the geometric center of the projection of the connecting arm 23 through the axis of the blocking frame 20 and extend it outward, that is, the central extension line of the connecting arm 23 is obtained.

[0081] In some embodiments, one end of the connecting arm 23 is connected to the main body portion 22, and this end is defined as the connecting end, and the other end extends radially outward, and this end is defined as the free end; optionally, the connection method between the connecting end and the main body portion 22 can be any one of welding, stitching, riveting or integrally forming.

[0082] Such as Figure 6 , in some embodiments, a second preset angle α2 is provided between the connecting arm 23 and the main body portion 22, 0° < α2 ≤ 60°, to ensure that after the blocking frame 20 is released, the connecting arm 23 can smoothly penetrate between adjacent coils of the fishing ring 10, or abut against the bottommost part of the fishing ring 10, and the part of the connecting arm 23 exposed radially outside the coil can extend obliquely upward to avoid affecting the normal movement of the valve.

[0083] Specifically, the second preset angle α2 refers to the inclination angle of the connecting arm 23 relative to the vertical direction. From the perspective of the spatial structure, the connecting arm 23 is not completely perpendicular to the bottom surface of the blocking frame 20, but has a certain inclination angle. Project the connecting arm 23 onto a cross-section perpendicular to the bottom surface of the blocking frame 20 (i.e., the vertical cross-section), and the angle formed between the projection line of the connecting arm 23 and the vertical direction is the second preset angle α2.

[0084] In some embodiments, an arc chamfer is further provided at the connecting end, and the inner diameter R1 of the arc of the arc chamfer is not less than the cross-sectional diameter of the coil of the fishing ring 10, so that when the connecting arm 23 is connected to the fishing ring 10, the coil can fall into this arc chamfer to increase the stability of their abutment / connection.

[0085] Such as Figure 7 — Figure 11 , in some embodiments, each connecting arm 23 is provided with at least one support rod 231, and the structural configuration of the support rod 231 is one or a combination of a straight line shape, an S shape, an arc shape, a ring shape, a wave shape or a spiral shape.

[0086] Specifically, the S-shaped structure can produce a certain elastic deformation when stressed to increase the flexibility of the connecting arm 23. The S-shaped structure can be set individually or continuously. When set continuously, it is a wavy structure, which can provide better elastic deformation ability. The arc-shaped structure is arranged in an arc shape, which can increase the contact area between the connecting arm 23 and the fishing ring 10 in the transverse direction to increase the transverse support strength. The annular structure is in a closed or semi-closed ring shape, which can provide an all-round support effect, and it can also be set individually or continuously. The spiral structure is wound in a spiral shape, which can provide a certain compressibility while ensuring the support strength. The above-mentioned different forms of the support rod 231 structures can be set individually or combined. For example, a linear and an S-shaped structure can be set on the same connecting arm 23 at the same time, or a combination of an S-shaped and an arc-shaped structure can be used to obtain better support effects and mechanical properties. In this embodiment, the specific structural form of the support rod 231 can be selected according to the size of the connecting arm 23, the expected stress situation, and the clinical use requirements.

[0087] In some embodiments, the support rod 231 can not only extend linearly in its extending direction, but also be in an arc-shaped structure bent towards the main body part 22. When the support rod 231 bends towards the main body part 22, its free end will be closer to the main body part 22. At this time, not only can the stability of the connection with the fishing ring 10 be increased, but also the coverage area of the support rod 231 in the radial direction can be reduced, thereby minimizing the interference with the surrounding tissues as much as possible.

[0088] In some embodiments, to increase the contact area with the fishing ring 10 and improve the structural strength at the same time, the connecting arm 23 preferably includes two support rods 231, and the two support rods 231 are arranged in contact with each other along their extending directions, or are separated at least in some sections along their extending directions.

[0089] Specifically, when the two support rods 231 are closely adjacent and are completely arranged in contact with each other along their extending directions, the two can form an integral support structure, and this setting method can provide greater support strength.

[0090] When the two support rods 231 are separated at least in some sections along their extending directions, the two support rods 231 can remain in contact in the area near the connection end, and gradually separate during the process of extending towards the free end, forming a certain distance, such as Figure 9 ; they can also remain separated throughout the extending direction, and a certain gap is formed between the two support rods 231, such as Figure 7 、 Figure 8 、 Figure 10 ; they can also maintain a certain distance in the area near the connection end and gradually merge or connect at the end point of the free end during the process of extending towards the free end, such as Figure 11At this time, since the two support rods 231 are separated in some sections, the contact area between the support structure and the fishing ring 10 can be increased, thereby improving the stability of the connection; secondly, the separated support rods 231 can disperse the force and avoid stress concentration; thirdly, the two support rods 231 are only attached or separated in some areas, which can also provide space for the valve tissue to move and reduce the impact on the valve function.

[0091] In some embodiments, the two support rods 231 are spaced apart at the connection end and connected at the free end to form a connection point, which forms a triangular support structure with the side wall of the main body 22, such as Figure 11 , Figure 12 On the one hand, when the blocking frame 20 is subjected to twisting and bending forces during transportation, the triangular support structure can effectively resist deformation, maintain the structural stability of the connecting arm 23, and avoid twisting and damage; on the other hand, after the blocking frame 20 is released and the connecting arm 23 and the fishing ring 10 are connected / abutted to each other, compared with the linear support structure, the triangular support structure has higher stability and can avoid the lateral deflection of the connecting arm 23 in the circumferential direction, so as to better maintain the shape and function of the connecting arm 23; on the other hand, when the blocking frame 20 is released and drives the fishing ring 10 to move in the vertical direction, the two connecting arms 23 have a total of four contact points to apply force to the fishing ring 10, and compared with the support rod 231 extending in a straight line, the force is more uniform and the support for the fishing ring 10 is more stable.

[0092] In some embodiments, when a triangular support structure is adopted, at least part of the two support rods 231 is preferably configured as an S-shaped structure, such as Figure 11 Specifically, when the occluder frame 20 is subjected to external force during transportation and implantation, the S-shaped structure can produce corresponding elastic deformation, which can not only buffer the impact force, but also restore the original shape after the external force disappears, so as to prevent the support rod 231 from permanent deformation or damage.

[0093] like Figure 13 — Figure 15 In some embodiments, each connecting arm 23 is further provided with a barb portion 232 at its free end, and the barb portion 232 extends radially toward the main body 22. At this time, a triangular structure is formed between the outer wall of the main body 22, the connecting arm 23 and the barb portion 232. One circle of the coil of the fishing ring 10 can pass through the space restricted by the triangular structure, so that the connection between the sealing frame 20 and the fishing ring 10 is more stable, avoiding unexpected displacement of the fishing ring 10.

[0094] In some embodiments, there is a third preset angle α3 between the barb portion 232 and the connecting arm 23. If the third preset angle α3 is too small, it will lead to insufficient assembly space for the fishing ring 10, which is not conducive to the insertion and positioning of the fishing ring 10. If it is too large, it will weaken the limiting effect of the barb portion 232 on the fishing ring 10, reduce the stability of the connection, and make the fishing ring 10 more easily detached from the triangular area. Therefore, preferably, 30°≤α3≤70°. This angle range can not only provide sufficient assembly space for the fishing ring 10 to ensure the smoothness of the assembly process, but also ensure that the barb portion 232 has a good limiting effect on the fishing ring 10 to achieve a stable and reliable connection.

[0095] Specifically, in the case where the barb portion 232 is not provided, the blocking frame 20 is fixed only by the direct contact between the connecting arm 23 and the fishing ring 10. Figure 16 At this time, when the blocking frame 20 is subjected to Figure 16 Due to the axial force in the direction of the middle arrow, the fishing ring 10 may slip along the connecting arm 23, resulting in an unstable connection and even causing the relative position of the sealing frame 20 and the fishing ring 10 to shift.

[0096] like Figure 17 When the barb 232 is provided at the free end of the connecting arm 23, the barb 232 radially extends toward the main body 22, and forms a triangular structure with the outer wall of the main body 22 and the connecting arm 23, providing a stable restraining space for the fishing ring 10. On the one hand, the coil of the fishing ring 10 can pass through the triangular area and be effectively limited, preventing the fishing ring 10 from sliding relative to each other under the action of the axial force; secondly, the triangular structure is not a closed structure, so it can still allow the fishing ring 10 to maintain a certain degree of freedom of movement in the axial direction while maintaining the connection stability, such as Figure 17 to the right of the figure, to avoid connections that are too rigid and affect the overall performance of the component or cause damage.

[0097] When the capture ring 10 and the occluder frame 20 are fully released, the chordae tendineae 40 of the patient will be clamped between the two. To avoid paravalvular leakage, the two must fit closely. However, since the interiors of both the occluder frame 20 and the capture ring 10 are made of hard materials, the chordae tendineae 40 are squeezed by the two. As the valve leaflets 50 move for a long time, the chordae tendineae 40 are repeatedly rubbed and pulled, which may break or cut the chordae tendineae 40. Therefore, in some embodiments, a sealing film 30 with a certain thickness and easy to be compressed is provided on the outer side of the main body portion 22 as a buffer layer; in some other embodiments, a sealing film 30 is also provided on the outer side of the skirt portion 21 to avoid paravalvular leakage. When the occluder frame 20 is implanted, the sealing film 30 on the outer side of the main body portion 22 serves as a buffer layer between the occluder frame 20 and the capture ring 10. When radial extrusion occurs between the two, the soft sealing film 30 can avoid direct hard contact and will not cause damage to the instrument, thereby improving the overall performance and safety of the assembly.

[0098] In some embodiments, the sealing film 30 can be made of materials with good biocompatibility such as PET, ePTFE, bovine pericardium or porcine pericardium, and the aforementioned materials have a certain thickness and are easy to be compressed.

[0099] In some embodiments, the thickness of the sealing film 30 is also an important specification parameter. If the thickness is too small, there will be no buffering or sealing effect. If the thickness is too large, it is not easy to be compressed, making it impossible for the occluder frame 20 to be loaded into the delivery device and then implanted through the catheter. Preferably, the thickness of the sealing film 30 is 0.3 - 1 mm.

[0100] Since there are two connecting arms 23, and the connecting arms 23 are preferably arranged at A1P1 and A3P3, the chordae tendineae 40 are concentrated on the circumferential two sides of the connecting arms 23, making the areas of the main body portion 22 on both sides of the connecting arms 23 bear greater stress and possible wear risk. Therefore, in some embodiments, double-layer sealing films 31 are locally provided on the main body portion 22 on both sides of the connecting arms 23, that is, corresponding to the areas where the chordae tendineae 40 are concentrated, such as Figure 18 、 Figure 19 、 Figure 20 ,for providing additional buffering and protective layers for the high-stress areas, increasing the buffering performance of the local areas, while ensuring functionality, avoiding thickening the sealing film 30 in non-essential areas to reduce the compressed size of the occluder frame 20 and ensure its passability during catheter delivery.

[0101] Such as Figure 19 ,when the occluder frame 20 and the capture ring 10 start to cooperate, since there is a double-layer sealing film 21 at the position of the main body portion 22 corresponding to the chordae tendineae 40, the thickness here can be further increased, improving the buffering performance, and avoiding the main body portion 22 and the capture ring 10 from squeezing and rubbing the chordae tendineae 40 here and causing damage to them; further by Figure 20It can be seen that during the working process of the assembly of the occlusion frame 20 and the capture ring 10, the tendon cord 40 is clamped between the capture ring 10 and the occlusion frame 20, and the tendon cord 40 sinks into the double-layer sealing film 21, thereby reducing the friction on the tendon cord 40 and preventing it from breaking.

[0102] Reference Figure 21 — Figure 26 , in the embodiment of the present invention, the delivery and release process of the occlusion frame 20 is as follows:

[0103] As Figure 21 , Figure 22 , when the occlusion frame 20 is delivered in the catheter 60, the occlusion frame 20 is compressed and loaded into the catheter 60, where the main body portion 22 and the connecting arm 23 are in a parallel state, and the entire occlusion frame 20 is in a compressed state; when the occlusion frame 20 starts to be delivered out of the catheter 60, the outflow end at the distal end first appears, and the connecting arm 23 gradually unfolds outward and simultaneously undergoes bending deformation, as Figure 23 , when the free end of the connecting arm 23 is also provided with a barb portion 232, at this time the barb portion 232 unfolds accordingly, but the connecting arm 23 has not yet reached its final shape; as the main body portion 22 of the occlusion frame 20 is delivered out of the catheter 60, the connecting arm 23 continues to unfold outward and further bends, as Figure 24 , Figure 25 ; at this time, the operator will operate the occlusion frame 20 to grasp the capture ring 10, and the barb portion 232 at the free end of the connecting arm 23 will hook the coil at the bottom of the capture ring 10; finally, the bending angle of the connecting arm 23 will reach 120 - 180°, at this time the occlusion frame 20 is completely released and reaches its expected working state, as Figure 26 , at this time the main body portion 22, the connecting arm 23 and the barb portion 232 of the occlusion frame 20 will surround the capture ring 10 and fix it.

[0104] In this embodiment, through the mutual cooperation between the occlusion frame 20 and the capture ring 10, an axial pre-tightening force can be formed between the capture ring 10 and the occlusion frame 20, so as to prompt the skirt portion 21 of the occlusion frame 20 to closely fit the atrial side wall, effectively solve the problems of paravalvular leakage and regurgitation, and at the same time can also fix the capture ring 10 below the valve annulus to ensure the position stability of the entire assembly.

[0105] Further, the occlusion frame 20 also has two connecting arms 23. The connecting arms 23 can penetrate into the gap in the junction area of the native valve leaflets 50 and are connected to the capture ring 10. The connecting arms 23 can be formed by connecting two support rods 231, and a triangular support structure is formed between the connecting arms 23 and the side wall of the main body 22. This can not only increase the contact area with the capture ring 10, making their cooperation more stable, but also prevent the connecting arms 23 from being twisted or folded during transportation in the delivery device, and avoid lateral deflection after release and after contacting the capture ring 10. A barb portion 232 can be further provided at the end of the connecting arm 23. The barb portion 232 extends radially in the direction of the main body 22. At this time, a triangular space for the capture ring 10 to pass through can be formed between the barb portion 232, the connecting arm 23 and the side wall of the main body 22, increasing the stability of the connecting arm 23 after hooking the capture ring 10.

[0106] Regarding the problem of possible damage to the chordae tendineae 40 caused by long-term implantation of the components, in the embodiment of the present invention, a sealing film 30 is specially provided outside the main body 22 of the occlusion frame 20, and a double-layer sealing film 31 design is adopted in key areas, especially in the areas on both circumferential sides of the connecting arm 23, to enhance the buffering performance and avoid the chordae tendineae 40 where the occlusion frame 20 and the capture ring 10 are squeezed and rubbed intensively.

[0107] Example 2

[0108] The embodiment of the present invention provides a transcatheter heart valve repair system, which includes the above-mentioned transcatheter heart valve repair component, and also includes a delivery device for delivering the component. The technical features already included in the above-mentioned Embodiment 1 are naturally inherited in this embodiment and will not be elaborated one by one.

[0109] In some embodiments, the transcatheter heart valve repair system includes a first delivery device and a second delivery device. Among them, the first delivery device is used to connect and deliver the capture ring 10 through the vascular access, and the second delivery device is used to connect and deliver the occlusion frame 20 through the vascular access. Through this dual-delivery device solution, the capture ring 10 and the occlusion frame 20 can be implanted in stages, which can effectively reduce the profile value of the delivery device, reduce the delivery difficulty, and reduce the harm to the patient's blood vessels.

[0110] Specifically, the first delivery device can adopt the structural design of the transcatheter capture ring delivery device in the prior art, and the second delivery device can adopt the structural design of the transcatheter artificial valve delivery device in the prior art. The specific structural forms of the aforementioned two delivery devices can refer to any applicable implementation in the prior art, and this embodiment does not make specific limitations.

[0111] Reference Figure 27 — Figure 32, in this embodiment, the working process of the transcatheter heart valve repair system is as follows:

[0112] Clinically, various pathological factors such as cardiac dilation and degenerative changes of valve tissue can cause the mitral valve annulus to expand in patients, such as Figure 27 , the expansion of the valve annulus causes the mitral valve to be unable to close completely during systole, resulting in valve regurgitation and affecting the normal function of the heart. In this pathological state, it is necessary to perform therapeutic intervention through the transcatheter heart valve repair system provided in this embodiment to restore the normal function of the valve.

[0113] First, the capture ring 10 is implanted through the first delivery device. After implantation, the capture ring 10 is located at the mitral valve annulus, such as Figure 28 , which can contract the enlarged mitral valve orifice due to the disease in the patient. However, due to the large subvalvular space of the mitral valve, after only implanting the capture ring 10, the capture ring 10 may displace in the vertical direction and even shift to the papillary muscle, unable to stabilize the valve annulus and unable to achieve the expected therapeutic effect. Therefore, next, the occlusion frame 20 is continuously implanted with the second delivery device. After reaching the target position, the connecting arm 23 located at the distal end of the occlusion frame 20 is first released, such as Figure 29 , by adjusting the position of the connecting arm 23, the connecting arm 23 is positioned at a specific position to hook the capture ring 10. It should be noted that the aforementioned specific position refers to the junction of the anterior and posterior leaflets of the mitral valve, that is, the junction point of A1P1 and A3P3.

[0114] Next, by pushing and pulling the second delivery device, the capture ring 10 is moved towards the mitral valve annulus, such as Figure 30 , at this time, since the connecting arm 23 of the occlusion frame 20 hooks the capture ring 10, when the second delivery device is pushed and pulled, the capture ring 10 can be driven to move together. Then, continue to push and pull the second delivery device to make it pass through the mitral valve annulus, ensuring that the skirt portion 21 of the occlusion frame 20 can be released on the atrial side of the patient. At this time, the capture ring 10 is compressed in the vertical direction. When it is compressed to the limit, the skirt portion 21 of the occlusion frame 20 is released, such as Figure 31 .

[0115] Such as Figure 32 , when the occlusion frame 20 is completely released, its skirt portion 21 is fixed at the valve orifice, thereby firmly restricting the capture ring 10 below the valve orifice. At this time, the capture ring 10 expands in the vertical direction through its own tension and forms a stable cooperation with the skirt portion 21 of the occlusion frame 20, acting on the valve tissue together. This structural cooperation not only ensures the stability of the capture ring 10 but also realizes the effective contraction of the valve orifice. At the same time, the close fit between the skirt portion 21 of the occlusion frame 20 and the valve can effectively prevent the occurrence of paravalvular leakage.

[0116] The embodiments of the present invention have been described above in conjunction with the accompanying drawings. However, the present invention is not limited to the above specific embodiments. The above specific embodiments are merely illustrative and not restrictive. Under the inspiration of the present invention, those of ordinary skill in the art can also make many forms without departing from the spirit of the present invention and the scope protected by the claims, and all of them fall within the protection scope of the present invention.

Claims

1. A transcatheter heart valve repair assembly, characterized in that: Includes fishing rings and blocking racks; The fishing ring is spiral-shaped, can be axially compressed, and is used to be coiled outside the chordae tendineae of the valve; The occlusion frame can be switched between a radially collapsed structure and a radially expanded structure, and the occlusion frame is provided with a skirt portion, a main body portion and a connecting portion in sequence from the blood inflow end to the blood outflow end; The skirt portion is radially extended outwards and is used to fit the atrial side wall and seal the valve orifice; The main body is in a hollow cylindrical shape and is connected to the small diameter end of the skirt; The connecting portion comprises a connecting arm, the connecting arm is folded from the blood outflow end to the blood inflow end, and the radial inner side of the connecting arm is used to connect or abut against the fishing ring; The cooperation between the connecting arm and the catching ring can form an axial preload between the catching ring and the occluding frame, and the axial preload is used to make the skirt portion seal against the atrial side wall and to axially position the catching ring.

2. The transcatheter heart valve repair assembly according to claim 1, characterized in that: The fishing ring has a natural state and a compressed state. The height of the fishing ring in the fully compressed state is smaller than its height in the natural state. The height of the main body is between the natural state height and the compressed state height of the fishing ring. The height difference between the fishing ring and the main body is used to generate axial compression deformation and maintain the axial preload force.

3. The transcatheter heart valve repair assembly according to claim 1, characterized in that: The inner diameter of the fishing ring in a natural state is smaller than the outer diameter of the main body in a radially expanded configuration, and the radial cooperation between the two is used to make the fishing ring fit tightly with the main body to form a circumferential seal.

4. The transcatheter heart valve repair assembly according to claim 1, characterized in that: The connecting portion is provided with two connecting arms, and the arrangement positions of the two connecting arms match the gap in the junction area of ​​the autologous valve leaflets, so that the connecting arms can pass outward from the gap in the junction area of ​​the autologous valve leaflets.

5. The transcatheter heart valve repair assembly according to claim 1, characterized in that: Each of the connecting arms comprises at least one supporting rod, one end of which is connected to the main body, and the other end of which extends radially outward and obliquely; The support rod is configured as one or more combinations of a straight line, an S-shape, an arc, a ring, a wave or a spiral.

6. The transcatheter heart valve repair assembly according to claim 5, characterized in that: The connecting arm includes two support rods, and the two support rods are arranged to fit each other along their extending direction, or are arranged to be separated in at least a portion of the sections along their extending direction.

7. The transcatheter heart valve repair assembly according to claim 6, characterized in that: The two support rods are connected at the ends away from the main body, and the connection points of the two support rods and the side walls of the main body form a triangular support structure.

8. The transcatheter heart valve repair assembly according to claim 5, characterized in that: The included angle between the connecting arm and the main body is 0° to 60°.

9. The transcatheter heart valve repair assembly according to any one of claims 5 to 8, characterized in that: The connecting arm is provided with a barb portion at the end away from the main body portion, and the barb portion radially extends toward the main body portion.

10. The transcatheter heart valve repair assembly according to claim 9, characterized in that: The barb portion, the side wall of the main body portion and the connecting arm form a triangular structure for the fishing ring to pass through.

11. The transcatheter heart valve repair assembly according to claim 10, characterized in that: An arc chamfer is provided at a connection area between the connecting arm and the main body, and an inner diameter of the arc of the arc chamfer is not less than a diameter of a coil cross section of the fishing ring.

12. The transcatheter heart valve repair assembly according to claim 1, characterized in that: A sealing film is disposed on the outer side of the main body, and the sealing film comprises PET, ePTFE, bovine pericardium or porcine pericardium material.

13. The transcatheter heart valve repair assembly according to claim 12, characterized in that: The sealing film is partially provided in double layers on the main body portion at both sides of the connecting arm.

14. A transcatheter heart valve repair system, characterized in that: A transcatheter heart valve repair assembly according to any one of claims 1 to 13, further comprising a first delivery device and a second delivery device; The first delivery device is used to connect to and deliver the fishing ring via a vascular access route; The second delivery device is used to connect and deliver the occlusion stent through a vascular access route.

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