Transcatheter heart valve repair assembly and system

Abstract

This invention relates to a transcatheter heart valve repair assembly and system. The assembly includes a catching ring and an occlusion frame. The catching ring is helical and axially compressible, used to coil around the chordae tendineae plexus of the valve. The occlusion frame can switch between a radially collapsed structure and a radially expanded structure. The occlusion frame has a skirt, a main body, and a connecting part sequentially from the blood inflow end to the blood outflow end. The skirt extends radially outward to conform to the atrial sidewall and seal the valve orifice. The main body is hollow and connected to the small-diameter end of the skirt. The connecting part includes a connecting arm that folds from the blood outflow end to the blood inflow end. The radially inner side of the connecting arm is used to connect to or abut against the catching ring. The engagement of the connecting arm and the catching ring can generate an axial preload between the catching ring and the occlusion frame. The axial preload is used to seal the skirt against the atrial sidewall and to axially position the catching ring.

Description

Technical Field

[0001] This invention relates to the field of medical devices for cardiac surgery, and more particularly to a transcatheter heart valve repair assembly and system. Background Technology

[0002] Mitral regurgitation is a common heart valve disease, mainly characterized by mitral valve insufficiency leading to blood regurgitation. Current treatment methods mainly include surgical treatment and transcatheter interventional treatment.

[0003] In traditional surgery, surgeons typically use an annuloplasty ring to repair the mitral valve. The annuloplasty ring can effectively reshape the dilated valve annulus, reduce the valve orifice area, and thus improve valve function. However, open-heart surgery is highly invasive, has a long recovery period, and is not suitable for all patients.

[0004] In recent years, transcatheter heart valve repair has gradually become an important option for treating mitral regurgitation. Currently, edge-to-edge repair is the most commonly used technique in clinical practice, which involves clamping the anterior and posterior leaflets together using specialized clips. While this method is minimally invasive, it is technically challenging because it requires accurately clamping the moving leaflets while the heart is beating. More importantly, when the repair device fails after long-term implantation, subsequent transcatheter treatment is often difficult.

[0005] On the other hand, although transcatheter implantation of an angioplasty rings is an ideal treatment option, there are currently few related devices. This is mainly due to two key technical challenges with transcatheter implantation of angioplasty rings: First, after implantation via catheter, the angioplasty ring is difficult to fix stably at the valve annulus and is prone to displacement; second, the angioplasty ring is difficult to fit tightly with the valve annulus, which may lead to paravalvular leakage and residual regurgitation, affecting the treatment effect. Summary of the Invention

[0006] This invention discloses a transcatheter heart valve repair component and system, which aims to solve the technical problems existing in the prior art.

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

[0008] On one hand, embodiments of the present invention provide a transcatheter heart valve repair assembly, including a catching ring and an occlusion frame;

[0009] The catching ring is spiral-shaped and can be compressed axially to be coiled around the chordae tendineae plexus of the valve;

[0010] The occlusion frame can switch between a radially collapsed structure and a radially expanded structure. The occlusion frame is provided with a skirt, a main body and a connecting part in sequence from the blood inflow end to the blood outflow end.

[0011] The skirt extends radially outward to fit against the atrial sidewall and seal the valve orifice;

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

[0013] The connecting part includes a connecting arm, which 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 to or abut against the fishing ring.

[0014] The connection between the connecting arm and the fishing ring creates an axial preload between the fishing ring and the sealing frame. This axial preload is used to seal the skirt against the atrial sidewall and to position the fishing ring axially.

[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. The height of the main body is between the height of the fishing ring in the natural state and the height in the compressed state. The height difference between the fishing ring and the main body is used to generate axial compression deformation and maintain axial preload.

[0016] As a preferred technical solution, the inner diameter of the fishing ring in its natural state is smaller than the outer diameter of the main body in its radial expansion structure. The radial fit between the two is used to make the fishing ring fit tightly against the main body to form a circumferential seal.

[0017] As a preferred technical solution, the connecting part is provided with two connecting arms. The positions of the two connecting arms are matched with the gaps in the junction area of ​​the autologous leaflets, so that the connecting arms can extend outward from the gaps in the junction area of ​​the autologous leaflets.

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

[0019] The support rod is configured in one or more combinations of straight, S-shaped, arc-shaped, ring-shaped, wave-shaped, or spiral shapes.

[0020] As a preferred technical solution, the connecting arm includes two support rods, which are fitted together along their extension direction or at least partially separated in their extension direction.

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

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

[0023] As a preferred technical solution, the connecting arm has a barb portion at the end away from the main body, and the barb portion extends radially toward the main body.

[0024] As a preferred technical solution, the barb, the sidewalls of the main body, and the connecting arm form a triangular structure for the fishing ring to pass through.

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

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

[0027] As a preferred technical solution, the sealing membrane is partially double-layered on both sides of the main body of the connecting arm.

[0028] On the other hand, embodiments of the present invention also provide a transcatheter heart valve repair system, including the transcatheter heart valve repair component as described in any of the preceding claims, and further including a first delivery device and a second delivery device;

[0029] The first delivery device is used to connect to and deliver the catching ring via the vascular access;

[0030] The second delivery device is used to connect to and deliver the occlusion stent via the vascular access route.

[0031] The technical solution adopted in this invention can achieve the following beneficial effects:

[0032] This invention provides a transcatheter heart valve repair assembly and system. The transcatheter heart valve repair assembly includes a retrieval ring and an occlusion frame. The retrieval ring adopts an open-ring structure and has vertical compression performance. Through the height difference design between the retrieval ring and the main body of the occlusion frame, an axial preload can be formed between the implanted retrieval ring and the occlusion frame to promote a tight fit between the skirt of the occlusion frame and the atrial sidewall, effectively solving the problems of paravalvular leakage and regurgitation. At the same time, it can also fix the retrieval ring below the valve annulus to ensure the positional stability of the entire assembly.

[0033] Furthermore, the blocking frame also has two connecting arms that can insert into the gap at the junction of the petals and connect with the catching ring. Each connecting arm can be formed by two support rods, creating a triangular support structure with the side wall of the main body. This not only increases the contact area with the catching ring, making their fit more stable, but also prevents the connecting arm from twisting or folding during transport within the conveying device, and avoids lateral deflection after release and contact with the catching ring. The end of the connecting arm can also be further provided with a barb extending radially towards the main body. In this case, a triangular space can be formed between the barb, the connecting arm, and the side wall of the main body for the catching ring to pass through, increasing the stability of the connecting arm after it abuts the catching ring.

[0034] To address the potential damage to the chordae tendineae caused by long-term implantation of components, this embodiment of the invention features a sealing membrane on the outer side of the main body of the occlusion frame. In key areas, particularly the areas on both sides of the connecting arm, a double-layer sealing membrane design is employed to enhance buffering performance and prevent the occlusion frame from being squeezed and rubbed against the chordae tendineae in these areas.

[0035] This invention further provides a catheter-based heart valve repair system, including a catheter-based heart valve repair component and a first delivery device and a second delivery device. The first delivery device is used to connect to and deliver a retrieval ring via a vascular access, and the second delivery device is used to connect to and deliver an occlusion stent via a vascular access. This dual delivery device scheme allows the retrieval ring and occlusion stent to be implanted in stages, effectively reducing the profile value of the delivery device, reducing delivery difficulty, and reducing damage to the patient's blood vessels. Attached Figure Description

[0036] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below, forming part of the present invention. The illustrative embodiments of the present invention and their descriptions explain the present invention and do not constitute an improper limitation of the present invention. In the accompanying drawings:

[0037] Figure 1 This is a schematic diagram of the structure of the fishing ring in its natural state in one embodiment of Embodiment 1 of the present invention;

[0038] Figure 2 This is a schematic diagram of the structure of the fishing ring in a compressed state according to one embodiment of the present invention;

[0039] Figure 3 This is a schematic diagram of the sealing frame structure in one embodiment of the present invention;

[0040] Figure 4 This is a schematic diagram of the structural cooperation between the fishing ring and the sealing frame in one embodiment of the present invention;

[0041] Figure 5 This is a top view of the sealing frame in one embodiment of the present invention (Example 1).

[0042] Figure 6 This is a front view of the sealing frame in one embodiment of Embodiment 1 of the present invention;

[0043] Figure 7 This is a schematic diagram of the connecting arm in one embodiment of the present invention;

[0044] Figure 8 This is a schematic diagram of the connecting arm in one embodiment of the present invention;

[0045] Figure 9 This is a schematic diagram of the connecting arm in one embodiment of the present invention;

[0046] Figure 10 This is a schematic diagram of the connecting arm in one embodiment of the present invention;

[0047] Figure 11 This is a schematic diagram of the connecting arm in one embodiment of the present invention;

[0048] Figure 12 for Figure 11 A schematic diagram of the connecting arm used in the sealing frame;

[0049] Figure 13 This is a schematic diagram of the connecting arm in one embodiment of the present invention;

[0050] Figure 14 for Figure 13 A schematic diagram of the connecting arm used in the sealing frame;

[0051] Figure 15 This is a schematic diagram of the structural cooperation between the fishing ring and the sealing frame in one embodiment of the present invention;

[0052] Figure 16 This is a schematic diagram showing the deformation of the sealing frame under axial pressure in one embodiment of the present invention;

[0053] Figure 17 This is a schematic diagram showing the deformation of the sealing frame under axial pressure in another embodiment of Embodiment 1 of the present invention.

[0054] Figure 18 This is a schematic diagram of the flat structure of the sealing frame in one embodiment of the present invention;

[0055] Figure 19 This is a bottom view of the main body of the fishing ring and the blocking frame after they are structurally assembled in one embodiment of the present invention (Example 1).

[0056] Figure 20 This is a bottom view of the main body of the fishing ring and the blocking frame during operation in one embodiment of the present invention;

[0057] Figure 21 — Figure 26 This is a schematic diagram of the release process of the sealing frame in one embodiment of the present invention;

[0058] Figure 27 — Figure 32 This is a schematic diagram of the working process of the transcatheter heart valve repair system in one embodiment of Example 2 of the present invention.

[0059] Explanation of reference numerals in the attached figures:

[0060] Fishing ring 10, sealing frame 20, skirt part 21, main body part 22, connecting arm 23, support rod 231, barb part 232, sealing membrane 30, double sealing membrane 31, tendineae 40, leaflets 50, duct 60. Detailed Implementation

[0061] To make the objectives, technical solutions, and advantages of this invention clearer, the technical solutions of this invention will be clearly and completely described below in conjunction with specific embodiments and corresponding drawings. In the description of this invention, it should be noted that the term "or" is generally used to include the meaning of "and / or," unless otherwise expressly indicated.

[0062] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; 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; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances. Furthermore, in the description of this application, the terms "first," "second," etc., are used only for distinguishing descriptions and should not be construed as indicating or implying relative importance. The term "proximal end" refers to the end along the length of the conveying device that is closer to the operator, and the term "distal end" refers to the end along the length of the conveying device that is farther from the operator.

[0063] Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention.

[0064] Example 1

[0065] Among the existing treatment options for mitral regurgitation, edge-to-edge clamping is less invasive, but it is difficult to accurately clamp the movable leaflet while the heart is beating, and it is difficult to perform subsequent transcatheter treatment after long-term implantation failure of the device. While transcatheter implantation of an angioplasty ring is an ideal solution, the angioplasty ring is difficult to fix stably at the valve annulus, and the angioplasty ring is difficult to fit tightly with the valve annulus, which may lead to paravalvular leakage and residual regurgitation.

[0066] To address the problems existing in the prior art, embodiments of the present invention provide a transcatheter heart valve repair assembly, referencing... Figure 1 — Figure 4The component includes a retrieval ring 10 and an occlusion frame 20. The retrieval ring 10 is implanted first during transcatheter valve repair. It can spirally wrap around the chordae tendineae plexus of the valve, thereby reducing the enlarged mitral valve orifice caused by the lesion. The occlusion frame 20 is implanted after the retrieval ring 10. Its main purpose is to cooperate with the retrieval ring 10 to fix its position, thereby achieving effective sealing of the valve orifice, further preventing blood backflow, and solving the paravalvular leakage problem that may be caused by simply implanting the retrieval ring 10.

[0067] like Figure 1 , Figure 2 In some embodiments, the capture ring 10 is configured as a helical open-loop multi-turn coil, preferably made of shape memory metal material, which can coil around the chordae tendineae plexus of the mitral valve after release and can be axially compressed. Specifically, the capture ring 10 can be straightened and stored in the delivery device during the delivery process, and released when it reaches the target position. Due to its material properties and structural design, it can automatically return to a preset helical state. The capture ring 10 can effectively wrap around the outer periphery of the chordae tendineae plexus of the mitral valve through this helical structure, thereby achieving the contraction of the enlarged valve orifice. At the same time, the design of the helical 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 catching ring 10 and the chordae tendineae, at least one bioadapter layer may be further provided on the outer surface of the catching ring 10. The bioadapter layer may be made of a soft biocompatible material, such as a PET film, ePTFE film, or PU film. By adding the bioadapter layer, on the one hand, the coefficient of friction between the catching ring 10 and the chordae tendineae can be increased, thereby improving the fixation stability of the device and preventing the catching ring 10 from undergoing undesirable axial displacement after implantation. On the other hand, it can reduce the mechanical stimulation of the chordae tendineae 40 tissue by the catching ring 10, reduce tissue damage and inflammatory response, and facilitate its long-term implantation effect.

[0069] In some embodiments, the fishing ring 10 has a natural state and a compressed state after release. The height in the natural state is L1, and the inner diameter is D1. The height in the fully compressed state is L2, where L1 > L2. In this embodiment, only the height relationship between the natural and compressed states of the fishing ring 10 is defined, without specifying the exact height value. Those skilled in the art can select or adjust the actual height value as needed. It should be noted that the aforementioned natural state refers to the spiral structure state of the fishing ring 10 after release from the core; the compressed state refers to a more compact spiral structure state formed by further axial compression under the spiral structure, not the straight structure state during transport.

[0070] Because the subvalvular space of the mitral valve is relatively large, using the retrieval ring 10 alone may pose a risk of longitudinal displacement. Specifically, after implantation, the retrieval ring 10 may shift towards the apex of the heart due to gravity and cardiac motion, eventually settling at the papillary muscle, thus failing to effectively clamp the valve annulus and affecting the treatment effect. For this reason, the occlusion frame 20 is subsequently implanted and used in conjunction with the retrieval ring 10 to prevent axial movement of the retrieval ring 10, ensuring its stable fixation in the target position, thereby achieving or further enhancing the expected treatment effect.

[0071] In some embodiments, the occlusion frame 20 is preferably made of a shape memory alloy material, such as a nickel-titanium alloy, whose overall structure can switch between a radially collapsed structure and a radially expanded structure, exhibiting a collapsed structure during transport and an expanded structure after release into the heart.

[0072] like Figure 3 In some embodiments, the occlusion frame 20 has one end as the blood inflow end, corresponding to the atrial side, and the other end as the blood outflow end, corresponding to the valve annulus side. The occlusion frame 20 is provided with a skirt portion 21, a main body portion 22, and a connecting portion in sequence from the blood inflow end to the outflow end. The skirt portion 21 is flange-shaped and extends radially outward to fit against the atrial sidewall and seal the valve orifice. The main body portion 22 is hollow cylindrical and is connected to the small-diameter end of the skirt portion 21. The connecting portion is also provided with a connecting arm 23, which is folded from the blood outflow end to the blood inflow end. The radially inner side of the connecting arm 23 is used to connect with or abut against the catching ring 10. The cooperation between the connecting arm 23 and the catching ring 10 can form an axial preload between the catching ring 10 and the occlusion frame 20. The axial preload is used to seal the skirt portion 21 against the atrial sidewall and to axially position the catching ring 10.

[0073] In some embodiments, the skirt portion 21 includes several diamond-shaped mesh supports and elastic connectors. One end of the diamond-shaped mesh support is connected to the main body portion 22 via the elastic connector, and the other end can be releasably connected to the corresponding conveying device during conveying. After release, the skirt portion 21 expands radially outward, and the projected area after expansion is preferably larger than the diameter of the valve orifice to ensure complete coverage of the valve orifice, thereby preventing paravalvular leakage. After the connecting arm 23 is connected to or abuts against the catching ring 10, the catching ring 10 pulls the entire assembly downward in the axial direction, so that the skirt portion 21 is further pressed against the atrial sidewall to further enhance the effect of preventing paravalvular leakage.

[0074] In some embodiments, the main body 22 includes one or more rows of polygonal grid structures, and adjacent grid structures are connected by elastic wave rods or nodes. The polygonal grid is preferably rhomboid, but pentagonal, hexagonal or other units that can form a closed shape can also be selected.

[0075] like Figure 3 , Figure 4In some embodiments, when the occlusion frame 20 is fully released, the axial height of the main body 22 is L3. Compared with the size parameters of the catching ring 10, L1 > L3 > L2. This height difference ensures that when the catching ring 10 and the occlusion frame 20 are fully released and used together, the catching ring 10 is in a compressed state in the axial direction, generating the aforementioned axial preload. This axial preload not only ensures that the catching ring 10 and the occlusion frame 20 are stably connected and fixed at the patient's valve annulus, but also allows the skirt 21 of the occlusion frame 20 to fit tightly against the atrial sidewall, effectively avoiding postoperative complications such as regurgitation and paravalvular leakage.

[0076] In some embodiments, when the sealing frame 20 is fully released, the outer diameter of the main body 22 is D2. Compared with the size parameter of the fishing ring 10, D2 is slightly larger than D1, so that the two can fit together radially without gap after release, forming a circumferential sealing clamp on the petal 50, further preventing the occurrence of petal leakage.

[0077] In some embodiments, the connecting part is provided with two connecting arms 23, which may be centrally symmetrical or asymmetrically distributed. When the blocking frame 20 is released, the connecting arms 23 extend radially outward and pass through the coil gap of the fishing ring 10 to connect with it. Alternatively, the connecting arms 23 extend outward from the bottom of the fishing ring 10 and abut against it to support the entire fishing ring 10.

[0078] like Figure 5 In some embodiments, since the human mitral valve leaflets 50 are not completely symmetrical, the two junctions of the anterior and posterior leaflets (i.e., the junctions of A1P1 and A3P3 in the mitral valve anatomy) are at a certain angle. Therefore, the distribution of the two connecting arms 23 is preferably matched with the gap in the junction area of ​​the autologous leaflets 50, so that the connecting arms 23 can pass outward from the gap in the junction area of ​​the autologous leaflets 50 and connect or abut with the catching ring 10. At this time, the presence of the connecting arms 23 will not obstruct the opening and closing movement of the patient's autologous leaflets 50, thereby avoiding the patient from losing mitral valve function during the operation, causing a large amount of regurgitation, and endangering life.

[0079] In some embodiments, a first preset included angle α1 is provided between the central extension lines of the two connecting arms 23, 160°≤α1≤180°. This angle matches the natural angle formed at the junction of the anterior and posterior leaflets of the mitral valve. It can be set according to the angle of the leaflet junction area of ​​different patients to ensure that the connecting arms 23 can pass through the gap in the junction area of ​​the leaflets 50 without affecting the normal movement function of the leaflets 50.

[0080] Specifically, the center extension line of the connecting arm 23 refers to an imaginary straight line formed by extending the axial center line of the projection of the connecting arm 23 onto the horizontal plane outward, and this extension line passes through the axis of the sealing frame 20. The aforementioned horizontal plane is the plane containing the bottom surface of the sealing frame 20, and the axis is the center of the circle projected onto the bottom surface. Structurally, although each connecting arm 23 is a slender component, it may actually have a certain tilt angle in space. Therefore, it is necessary to project it onto the horizontal plane and draw a straight line through the axis of the sealing frame 20, passing through the geometric center of the projection of the connecting arm 23 and extending it outward, thus obtaining the center extension line of the connecting arm 23.

[0081] In some embodiments, one end of the connecting arm 23 is connected to the main body 22 and is defined as the connecting end, while the other end extends radially outward and is defined as the free end; optionally, the connection between the connecting end and the main body 22 can be any one of welding, sewing, riveting or integral molding.

[0082] like Figure 6 In some embodiments, a second preset included angle α2 is provided between the connecting arm 23 and the main body 22, where 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 bottom of the fishing ring 10. The part of the connecting arm 23 exposed in the coil in the radial direction can extend upward at an angle to avoid affecting the normal activity of the valve.

[0083] Specifically, the second preset angle α2 refers to the tilt angle of the connecting arm 23 relative to the vertical direction. From a spatial perspective, the connecting arm 23 is not completely perpendicular to the bottom surface of the sealing frame 20, but has a certain tilt angle. Projecting the connecting arm 23 onto a cross-section perpendicular to the bottom surface of the sealing frame 20 (i.e., a vertical cross-section), 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, the connecting end is further provided with an arc-shaped chamfer, and the inner diameter R1 of the arc-shaped 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 the arc-shaped chamfer to increase the stability of the contact / connection between the two.

[0085] like Figure 7 — Figure 11 In some embodiments, each connecting arm 23 is provided with at least one support rod 231, and the support rod 231 is configured to be one or more combinations of straight, S-shaped, arc-shaped, ring-shaped, wavy or spiral.

[0086] Specifically, the S-shaped structure can generate a certain elastic deformation under stress to increase the flexibility of the connecting arm 23. The S-shaped structure can be set individually or continuously. When continuously set, it is a wave-shaped structure, which can provide better elastic deformation capability. 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 lateral direction, thereby increasing the lateral support strength. The ring structure is a closed or semi-closed ring, which can provide all-round support. It can also be set individually or continuously. The spiral structure is spirally wound, which can provide a certain degree of compressibility while ensuring support strength. The aforementioned different forms of support rod 231 structures can be set individually or in combination. For example, straight and S-shaped structures, or a combination of S-shaped and arc-shaped structures, can be set on the same connecting arm 23 to obtain better support effect and mechanical performance. 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 condition, and clinical use requirements.

[0087] In some embodiments, the support rod 231 can extend not only in a straight line in its extension direction, but also in an arc-shaped structure that bends toward the main body 22. When the support rod 231 bends toward the main body 22, its free end will be closer to the main body 22. This not only increases the stability of the connection with the fishing ring 10, but also reduces the radial coverage area of ​​the support rod 231, thereby minimizing interference with the surrounding tissues.

[0088] In some embodiments, in order to increase the contact area with the fishing ring 10 and improve the structural strength, the connecting arm 23 preferably includes two support rods 231, which are attached to each other along their extension direction, or at least partially separated in their extension direction.

[0089] Specifically, when the two support rods 231 are closely adjacent and fully fitted along their extension direction, they can form an integral support structure, which can provide greater support strength.

[0090] When at least a portion of the two support rods 231 are separated from each other in their extending direction, the two support rods 231 can remain close together near the connecting end, and gradually separate as they extend toward the free end, forming a certain gap, such as Figure 9 Alternatively, they can remain separated throughout the entire extension direction, with a certain gap between the two support rods 231, such as... Figure 7 , Figure 8 , Figure 10 Alternatively, a certain distance can be maintained in the area near the connection end, and the connection can be gradually made up as it extends toward the free end, or the connection can be made at the endpoint of the free end, such as... Figure 11At this point, 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, thus improving the stability of the connection. Secondly, the separated support rods 231 can distribute the force and avoid stress concentration. Thirdly, the fact that the two support rods 231 are only attached or separated in some areas can also provide space for the valve tissue to move, reducing the impact on valve function.

[0091] In some embodiments, two support rods 231 are spaced apart at the connecting end and connected at the free end, forming a connection point thereon. This connection point and the side wall of the main body 22 form a triangular support structure, such as... Figure 11 , Figure 12 On the one hand, when the blocking frame 20 is subjected to torsional and bending forces during transport, the triangular support structure can effectively resist deformation, maintain the structural stability of the connecting arm 23, and avoid torsion and damage. On the other hand, after the blocking frame 20 is released and the connecting arm 23 is connected / aggregated with the fishing ring 10, the triangular support structure has higher stability than the straight support structure, which can prevent the connecting arm 23 from lateral deflection in the circumferential direction, so as to better maintain the shape and function of the connecting arm 23. Furthermore, 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 that apply force to the fishing ring 10. Compared with the straight and close-fitting support rod 231, the force is more uniform and the support for the fishing ring 10 is more stable.

[0092] In some embodiments, when employing a triangular support structure, at least a portion of the two support rods 231 are preferably configured as an S-shaped structure, such as... Figure 11 Specifically, when the sealing frame 20 is subjected to external force during delivery and implantation, the S-shaped structure can generate corresponding elastic deformation, which can both buffer the impact force and restore the original shape after the external force disappears, so as to prevent the support rod 231 from being permanently deformed or damaged.

[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. The barb portion 232 extends radially toward the main body 22. At this time, the outer wall of the main body 22, the connecting arm 23 and the barb portion 232 form a triangular structure. One coil of the fishing ring 10 can pass through the space restricted by the triangular structure, making the connection between the blocking frame 20 and the fishing ring 10 more stable and preventing the fishing ring 10 from being displaced undesirably.

[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, the assembly space of the fishing ring 10 will be insufficient, 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 it easier for the fishing ring 10 to detach from the triangular area. Therefore, preferably, 30°≤α3≤70°. This angle range can provide sufficient assembly space for the fishing ring 10 to ensure the smoothness of the assembly process, and can also ensure that the barb portion 232 has a good limiting effect on the fishing ring 10, so as to achieve a stable and reliable connection.

[0095] Specifically, without the barb 232, the blocking frame 20 is fixed solely 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 such Figure 16 The axial force in the direction of the middle arrow may cause the fishing ring 10 to slip along the connecting arm 23, resulting in unstable connection and even causing the relative position of the blocking frame 20 and the fishing ring 10 to shift.

[0096] like Figure 17 When a barb 232 is provided at the free end of the connecting arm 23, the barb 232 extends radially toward the main body 22, forming a triangular structure with the outer wall of the main body 22 and the connecting arm 23. This provides a stable constraint space for the fishing ring 10. On the one hand, the coil of the fishing ring 10 can pass through this triangular area and be effectively limited, preventing the fishing ring 10 from sliding relative to each other under axial force. On the other hand, this triangular structure is not a closed structure, so it can still maintain a certain degree of freedom of movement in the axial direction while maintaining connection stability. Figure 17 The diagram on the right shows how to avoid overly rigid connections that could affect the overall performance of the components or cause damage.

[0097] After the retrieval ring 10 and the occlusion frame 20 are fully released, the patient's chordae tendineae 40 will be sandwiched between them. To avoid paravalvular leakage, the two must fit tightly together. However, since the interiors of the occlusion frame 20 and the retrieval ring 10 are made of rigid materials, the chordae tendineae 40 is compressed by them. With the prolonged movement of the leaflet 50, the chordae tendineae 40 is repeatedly rubbed and pulled, which may break or sever the chordae tendineae 40. Therefore, in some embodiments, a sealing membrane 30 of a certain thickness and easily compressible is provided on the outer side of the main body 22 as a buffer layer; in other embodiments, a sealing membrane 30 is also provided on the outer side of the skirt 21 to avoid paravalvular leakage. After the occlusion frame 20 is implanted, the sealing membrane 30 on the outer side of the main body 22 acts as a buffer layer between the occlusion frame 20 and the retrieval ring 10. When radial compression occurs between the two, the soft sealing membrane 30 can avoid direct hard contact and prevent damage to the device, thereby improving the overall performance and safety of the component.

[0098] In some embodiments, the sealing film 30 may be selected from materials with good biocompatibility such as PET, ePTFE, bovine pericardium or porcine pericardium, and the aforementioned materials have a certain thickness and are easily compressed.

[0099] In some embodiments, the thickness of the sealing membrane 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 will not be easily compressed, making it impossible for the sealing frame 20 to be loaded into the delivery device and implanted through the conduit. Preferably, the thickness of the sealing membrane 30 is 0.3-1mm.

[0100] Because there are two connecting arms 23, and the connecting arms 23 are preferably located at A1P1 and A3P3, the tendineae 40 are concentrated on both circumferential sides of the connecting arms 23, causing the main body portion 22 areas on both sides of the connecting arms 23 to bear greater stress and potential wear risk. Therefore, in some embodiments, a double-layer sealing membrane 31 is provided locally on the main body portion 22 on both sides of the connecting arms 23, corresponding to the area where the tendineae 40 are concentrated, such as... Figure 18 , Figure 19 , Figure 20 It is used to provide an additional buffer and protective layer for high-stress areas, increase the buffering performance of local areas, and avoid thickening the sealing membrane 30 in unnecessary areas while ensuring functionality, so as to reduce the compression size of the sealing frame 20 and ensure its passage when transported through the conduit.

[0101] like Figure 19 When the sealing frame 20 and the fishing ring 10 begin to engage, the double-layer sealing film 21 on the main body 22 corresponding to the tendon 40 further increases the thickness at this location, improving the buffering performance and preventing the main body 22 from squeezing or rubbing against the tendon 40 at this location, thus avoiding damage. Figure 20It can be seen that during the assembly process of the sealing frame 20 and the fishing ring 10, the tendon cable 40 is clamped between the fishing ring 10 and the sealing frame 20, and the tendon cable 40 is embedded in the double-layer sealing membrane 21, thereby reducing the friction on the tendon cable 40 and preventing it from breaking.

[0102] refer to Figure 21 — Figure 26 In this embodiment of the invention, the conveying and releasing process of the sealing frame 20 is as follows:

[0103] like Figure 21 , Figure 22 When the plugging frame 20 is conveyed in the conduit 60, it is compressed and installed inside the conduit 60, with the main body 22 and the connecting arm 23 in a parallel state, and the entire plugging frame 20 is in a compressed state; when the plugging frame 20 begins to be conveyed out of the conduit 60, the distal outflow end is exposed first, and the connecting arm 23 gradually unfolds outward while bending and deforming, as shown in the figure. Figure 23 When the free end of the connecting arm 23 still has a barb 232, the barb 232 unfolds accordingly, but the connecting arm 23 has not yet reached its final shape; as the main body 22 of the sealing frame 20 is conveyed out of the conduit 60, the connecting arm 23 continues to unfold outward and bend further, as... Figure 24 , Figure 25 At this point, the operator will manipulate the blocking frame 20 to grab the fishing ring 10, and the barb 232 at the free end of the connecting arm 23 will hook the coil at the bottom of the fishing ring 10; finally, the bending angle of the connecting arm 23 will reach 120-180°, at which point the blocking frame 20 will be fully released, achieving its expected working state, such as... Figure 26 At this time, the main body 22, connecting arm 23 and barb 232 of the blocking frame 20 will surround the fishing ring 10 and fix it.

[0104] In this embodiment, the cooperation between the occlusion frame 20 and the catching ring 10 enables an axial preload to be formed between the catching ring 10 and the occlusion frame 20, so as to make the skirt 21 of the occlusion frame 20 fit tightly against the atrial sidewall, effectively solving the problems of paravalvular leakage and regurgitation. At the same time, the catching ring 10 can be fixed below the valve annulus to ensure the positional stability of the entire assembly.

[0105] Furthermore, the blocking frame 20 also has two connecting arms 23, which can be inserted into the gap at the junction of the self-petal 50 and connected to the catching ring 10. The connecting arms 23 can be formed by connecting two support rods 231, forming a triangular support structure with the side wall of the main body 22. This not only increases the contact area with the catching ring 10, making the fit between the two more stable, but also prevents the connecting arms 23 from twisting or folding during transport in the conveying device, and also prevents lateral deflection after release and after contact with the catching ring 10. The end of the connecting arm 23 can also be further provided with a barb 232, which extends radially toward the main body 22. At this time, a triangular space for the catching ring 10 to pass through can be formed between the barb 232, the connecting arm 23 and the side wall of the main body 22, increasing the stability of the connecting arm 23 after it abuts the catching ring 10.

[0106] To address the potential damage to the tendon chordae 40 caused by long-term implantation of the component, this embodiment of the invention features a sealing membrane 30 on the outer side of the main body 22 of the sealing frame 20. In key areas, particularly the areas on both sides of the connecting arm 23, a double-layer sealing membrane 31 design is employed to enhance buffering performance and prevent the sealing frame 20 from being squeezed and rubbed by the fishing ring 10, which would concentrate on the tendon chordae 40 in these areas.

[0107] Example 2

[0108] This invention provides a transcatheter heart valve repair system, which includes the aforementioned transcatheter heart valve repair component and a delivery device for delivering the component. The technical features already included in Embodiment 1 are naturally inherited in this embodiment and will not be described in detail again.

[0109] In some embodiments, the transcatheter heart valve repair system includes a first delivery device and a second delivery device, wherein the first delivery device is used to connect to and deliver a retrieval ring 10 via a vascular access, and the second delivery device is used to connect to and deliver an occlusion frame 20 via a vascular access. This dual delivery device approach allows the retrieval ring 10 and the occlusion frame 20 to be implanted in stages, effectively reducing the profile value of the delivery devices, simplifying delivery, and minimizing damage to the patient's blood vessels.

[0110] Specifically, the first delivery device can adopt the structural design of a transcatheter retrieval ring delivery device in the prior art, and the second delivery device can adopt the structural design of a 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 specifically limit them.

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

[0112] Clinically, various pathological factors, such as cardiac enlargement and degenerative changes in valvular tissue, can lead to mitral valve annulus enlargement in patients. Figure 27 Enlargement of the valvular annulus prevents the mitral valve from closing completely during systole, resulting in valvular regurgitation and affecting normal heart function. In this pathological state, treatment intervention using the transcatheter heart valve repair system provided in this embodiment is necessary to restore normal valve function.

[0113] First, the catching ring 10 is implanted via the first delivery device. After implantation, the catching ring 10 is located at the annulus of the mitral valve, such as... Figure 28 This method can constrict the mitral valve orifice due to enlargement caused by the lesion. However, because the subventricular space of the mitral valve is large, after implanting only the retrieval ring 10, the retrieval ring 10 may shift vertically, or even move to the papillary muscle, failing to stabilize the valve annulus and thus failing to achieve the expected therapeutic effect. Therefore, the second delivery device is used to implant the occlusion frame 20. 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 to hook the fishing ring 10 at a specific location. It should be noted that the aforementioned specific location refers to the junction of the anterior and posterior mitral valve leaflets, that is, the junction of A1P1 and A3P3.

[0114] Next, by pushing and pulling the second conveying device, the catching ring 10 is moved towards the mitral valve ring, as shown. Figure 30 At this point, because the connecting arm 23 of the occlusion frame 20 has hooked the retrieval ring 10, pushing or pulling the second delivery device can move the retrieval ring 10 along with it. Then, continue pushing or pulling the second delivery device to allow it to pass through the mitral valve annulus, ensuring that the skirt 21 of the occlusion frame 20 can be released on the patient's atrial side. At this time, the retrieval ring 10 is compressed in the vertical direction. When it is compressed to its limit, the skirt 21 of the occlusion frame 20 is released, as... Figure 31 .

[0115] like Figure 32 When the occlusion frame 20 is fully released, its skirt 21 is fixed at the valve orifice, thus firmly restricting the catching ring 10 below the valve orifice. At this time, the catching ring 10 unfolds vertically by its own tension, forming a stable fit with the skirt 21 of the occlusion frame 20, working together to act on the valve tissue. This structural fit ensures the stability of the catching ring 10 and achieves effective valve orifice contraction. At the same time, the tight fit between the skirt 21 of the occlusion frame 20 and the valve effectively prevents paravalvular leakage.

[0116] The embodiments of the present invention have been described above with reference to the accompanying drawings. However, the present invention is not limited to the specific embodiments described above. The specific embodiments described above are merely illustrative and not restrictive. Those skilled in the art can make many other modifications under the guidance of the present invention without departing from the spirit and scope of the claims, and all of these modifications are within the protection scope of the present invention.

Claims

1. A transcatheter heart valve repair assembly, characterized in that, Including fishing rings and blocking frames; The catching ring is spiral-shaped and axially compressible, used to coil around the chordae tendineae plexus of the valve; the catching ring has a natural state and a compressed state after release, and the height of the catching ring in the fully compressed state is less than its height in the natural state. The occlusion frame can switch between a radially collapsed structure and a radially expanded structure. The occlusion frame is provided with a skirt, a main body and a connecting part in sequence from the blood inflow end to the blood outflow end. The skirt extends radially outward to fit against the atrial sidewall and seal the valve orifice; The main body is hollow cylindrical and connected to the small-diameter end of the skirt; the height of the main body is between the natural height and the compressed height of the fishing ring. The connecting part includes a connecting arm, which is folded from the blood outflow end to the blood inflow end, and the radially inner side of the connecting arm is used to connect to or abut against the fishing ring. The engagement of the connecting arm with the catching ring can generate an axial preload between the catching ring and the sealing frame. The preload is generated and maintained by the height difference between the catching ring and the main body after they are fully released. The axial preload is used to seal the skirt part against the atrial sidewall and to axially position the catching ring.

2. The transcatheter heart valve repair assembly according to claim 1, characterized in that, The inner diameter of the fishing ring in its natural state is smaller than the outer diameter of the main body in its radial expansion configuration. The radial fit between the two is used to ensure that the fishing ring and the main body fit tightly together to form a circumferential seal.

3. The transcatheter heart valve repair assembly according to claim 1, characterized in that, The connecting part is provided with two connecting arms, and the positions of the two connecting arms are matched with the gaps in the autologous leaflet junction area, so that the connecting arms can extend outward from the gaps in the autologous leaflet junction area.

4. The transcatheter heart valve repair assembly according to claim 1, characterized in that, Each of the connecting arms includes at least one support rod, one end of which is connected to the main body and the other end extends radially outward and obliquely. The support rod is configured in one or more combinations of straight, S-shaped, arc-shaped, ring-shaped, wave-shaped, or spiral shapes.

5. The transcatheter heart valve repair assembly according to claim 4, characterized in that, The connecting arm includes two support rods, which are fitted together along their extension direction or are separated in at least a portion of their extension direction.

6. The transcatheter heart valve repair assembly according to claim 5, characterized in that, The two support rods are connected at their ends away from the main body, and the connection point of the two support rods and the side wall of the main body form a triangular support structure.

7. The transcatheter heart valve repair assembly according to claim 4, characterized in that, The angle between the connecting arm and the main body is 0° to 60°.

8. The transcatheter heart valve repair assembly according to any one of claims 4-7, characterized in that, The connecting arm has a barb portion at its end away from the main body, and the barb portion extends radially toward the main body.

9. The transcatheter heart valve repair assembly according to claim 8, characterized in that, The barb, the sidewall of the main body, and the connecting arm form a triangular structure for the fishing ring to pass through.

10. The transcatheter heart valve repair assembly according to claim 9, characterized in that, The connection area between the connecting arm and the main body is provided with an arc-shaped chamfer, and the inner diameter of the arc-shaped chamfer is not less than the diameter of the coil cross-section of the fishing ring.

11. The transcatheter heart valve repair assembly according to claim 1, characterized in that, The outer side of the main body is provided with a sealing film, which includes PET, ePTFE, bovine pericardium or porcine pericardium material.

12. The transcatheter heart valve repair assembly according to claim 11, characterized in that, The sealing membrane is partially double-layered on both sides of the main body of the connecting arm.

13. A transcatheter heart valve repair system, characterized in that, The transcatheter heart valve repair assembly as described in any one of claims 1-12 further includes a first delivery device and a second delivery device; The first delivery device is used to connect to and deliver the catching ring via the blood vessel access route; The second delivery device is used to connect to and deliver the occlusion stent via the vascular access route.

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