A transcatheter valve replacement device and stent thereof

Abstract

The present invention provides a transcatheter valve replacement device and a stent thereof, which relate to the field of heart valve technology. The transcatheter valve replacement stent includes a stent body and an anchoring structure. The stent body is a cylindrical frame structure that can be radially compressed and expanded, and has a gripping state and an expanded state; the anchoring structure is arranged on the outer ring of the stent body around the stent body, suitable for anchoring the stent body; when the stent body is in the gripping state, the anchoring structure at least partially overlaps with the stent body in the radial direction, so that the transcatheter valve replacement stent forms a double-layer frame structure when gripped. The present invention can solve the problem of difficulty in bending in a narrow space during the delivery of the replacement valve stent in the prior art. The present invention can shorten the length of the replacement valve stent after gripping, and shorten the length of the bending sheath, so that the replacement valve stent can avoid large-angle bends during the release process in a narrow space, making it easier to bend the bending sheath.

Description

Technical Field

[0001] The present invention relates to the technical field of heart valves, and in particular to a transcatheter valve replacement device and a stent thereof. Background Art

[0002] Transcatheter mitral valve replacement (TMVR) does not require thoracotomy, cardiac arrest, or extracorporeal circulation, greatly reducing surgical trauma and becoming another research hotspot after transcatheter aortic valve replacement (TAVR). After the replacement valve is punctured through the ventricular septum, it needs to be bent at a larger angle so that the replacement operation can be performed perpendicular to the plane of the mitral valve. However, the size of the left ventricle in the human body varies not only in different disease courses, but also in different individuals. During the delivery of existing mitral valve replacement stents, there are defects such as difficulty in bending in the narrow space of the left ventricle and higher requirements for the mechanical strength and performance of the bending sheath of the delivery system. Summary of the Invention

[0003] The technical problem to be solved by the present invention is to overcome the defect of difficulty in bending the replacement valve stent in a narrow space during transportation in the prior art, thereby providing a transcatheter replacement valve device and its stent.

[0004] To address the aforementioned issues, the present invention provides, in one aspect, a transcatheter valve replacement stent, comprising a stent body and an anchoring structure. The stent body is a cylindrical frame structure that can be radially compressed and expanded, having a compressed state and an expanded state. The anchoring structure is disposed around the outer circumference of the stent body. When the stent body is in the compressed state, the anchoring structure at least partially overlaps the stent body in the radial direction, forming a double-layer frame structure for the transcatheter valve replacement stent when compressed. When the stent body is in the expanded state, the anchoring structure expands outward from the stent body to anchor the stent body.

[0005] Optionally, the anchoring structure includes a plurality of anchoring members arranged at intervals around the outer periphery of the stent body, the anchoring members having a fixed end and a free end, and the fixed end is connected to the stent body; when the stent body is in the expanded state, the free end expands radially outward along the stent body, suitable for providing radial anchoring force for the stent body.

[0006] Optionally, the anchor member includes an anchor rod, which includes a first rod segment, a second rod segment and an intermediate rod segment connecting the first rod segment and the second rod segment; the intermediate rod segment is a bent rod, and the first ends of the first rod segment and the second rod segment are connected to the first end of the bracket body to form a fixed end, and the second ends of the first rod segment and the second rod segment extend axially toward the second end of the bracket body, and are connected to form a closed loop structure through the intermediate rod segment, and the intermediate rod segment constitutes a free end.

[0007] Optionally, the outer contour of the bending portion of the middle rod segment is a smooth arc.

[0008] Optionally, among the multiple anchoring rods, at least half of the intermediate rod segments are bent radially toward or away from the stent body to prevent myocardial tissue from being injured.

[0009] Optionally, the first rod segment includes a first bending portion and a second bending portion arranged in sequence from the first end to the second end, the first bending portion is bent radially close to the protrusion of the bracket body, and the second bending portion is bent radially away from the protrusion of the bracket body; the second rod segment has the same structure as the first rod segment.

[0010] Optionally, the fixed end is connected to the first end of the stent body, and the free end extends toward the second end of the stent body, so that when the stent body is in a gripping state, at least one of the stent body and the anchoring structure completely overlaps with the other in the radial direction.

[0011] Optionally, a skirt structure is further included, which is arranged around the periphery of the stent body. When the stent body is in the expanded state, the anchoring structure cooperates with the skirt structure to clamp the autologous valve leaflet.

[0012] Optionally, the skirt structure is an annular frame structure, the inner ring of the skirt structure is connected to the second end of the bracket body, and the outer ring of the skirt structure extends toward the outside of the bracket body.

[0013] Optionally, the skirt support structure includes a first skirt support segment connected to the bracket body and a second skirt support segment connected to the first skirt support segment. The first skirt support segment is bent away from the bracket body along the radial direction of the bracket body, and the second skirt support segment is bent close to the bracket body along the radial direction of the bracket body.

[0014] Optionally, a mesh opening is provided between the first support section and the bracket body or between the first support section and the second support section, and the free end extends into the mesh opening.

[0015] Optionally, a reinforcement structure is connected between two adjacent anchoring members.

[0016] Optionally, the reinforcement structure includes a reinforcement rod, which is a combination of one or more shapes such as V-shape, U-shape, and W-shape, and both ends of the reinforcement rod are respectively connected to two adjacent anchoring members.

[0017] Optionally, the second end of the bracket body is provided with a conveying connection structure, which includes a plurality of connecting rods arranged at intervals around the bracket body, one end of the connecting rod is connected to the second end of the bracket body, and the other end of the connecting rod extends away from the second end of the bracket body along the axial direction of the bracket body, and a hanging portion is provided at the end portion, which is suitable for connecting to the conveying system.

[0018] Optionally, a plurality of leaflet suture ears are provided around the stent body.

[0019] Another aspect of the present invention provides a transcatheter valve replacement device, comprising the transcatheter valve replacement stent according to any one of the above technical solutions.

[0020] Optionally, the bracket body has a skirt structure, and a sealing skirt cloth is connected to the skirt structure. The sealing skirt cloth is arranged around the bracket body and is fitly arranged on the inner side of the bracket body. The first end of the sealing skirt cloth is connected to the skirt structure, and the second end of the sealing skirt cloth extends toward the first end of the bracket body.

[0021] Optionally, the transcatheter valve replacement stent further includes a leaflet suture ear, and the second end of the sealing skirt partially or completely covers the leaflet suture ear.

[0022] Optionally, the transcatheter valve replacement stent also includes leaflet suture ears, and an artificial valve is sutured and connected to the inner side of the stent body at the leaflet suture ears; the artificial valve has two pieces, suitable for replacing the patient's mitral valve; or, the artificial valve has three pieces, suitable for replacing the patient's aortic valve; or, the artificial valve has four pieces, suitable for the heart valves of special patients.

[0023] The present invention has the following advantages:

[0024] 1. By utilizing the technical solution of the present invention, since the stent body is in a clamped state, the anchoring structure at least partially overlaps with the stent body in the radial direction. Compared with the existing replacement valve stent, the present invention can shorten the length of the replacement valve stent after clamping, so that in the delivery system, the length of the bending sheath occupied is short, so that the replacement valve stent can avoid large-angle bends during the release process in a narrow space, making the bending sheath easier to bend and reducing the mechanical strength and performance requirements of the bending sheath of the delivery system.

[0025] 2. In the clamped state, at least one of the stent body and the anchoring structure completely overlaps with the other in the radial direction, which can maximize the shortening of the axial length of the transcatheter valve replacement stent after clamping, and further reduce the difficulty of bending the sheath during delivery.

[0026] 3. The first rod segment and the second rod segment of the anchor rod are connected to form a closed-loop structure through the middle rod segment, which improves the strength of the anchor rod and at the same time improves the circumferential support force of the anchor rod around the stent body. After the replacement valve stent is anchored, circumferential displacement is not easy to occur. Compared with the structure of a single anchor rod, the replacement valve stent of the present invention is more stable; in addition, since the anchor rod is a closed-loop structure, compared with a single anchor rod, the anchor rod of the present invention is easier to cross the chordae tendineae, avoiding pulling the chordae tendineae and causing unnecessary damage to the patient.

[0027] 4. The outer contour of the bend of the middle rod section of the anchor rod is a smooth arc, so that the free end of the anchor rod has a smooth structure, which can effectively prevent the anchor structure from causing complications due to puncturing the native valve leaflet or myocardial tissue during the anchoring process.

[0028] 5. Among the multiple anchoring rods, at least half of the intermediate rod segments are bent radially toward or away from the stent body. This differentiated arrangement of the anchoring rods enables the replacement valve stent to adapt to the anterior cusp and posterior cusp of the mitral valve respectively, making the transcatheter replacement valve stent more adaptable to the physiological characteristics of the mitral valve while ensuring that the myocardial tissue or the native valve leaflets are not injured.

[0029] 6. Compared to solutions that rely solely on anchoring structures to provide radial support, the present invention utilizes a combination of the anchoring structure and the support structure to clamp the native valve leaflets. This provides stable clamping, preventing displacement of the prosthetic valve and preventing paravalvular leakage or other complications. Specifically, after the transcatheter valve replacement stent is released, the support structure is positioned on the atrial side of the native valve leaflets, while the anchoring structure is positioned on the ventricular side. The free end of the anchor extends into the mesh opening of the support structure, clamping the roots of the native valve leaflets. This provides a more effective clamping effect and makes the transcatheter valve replacement more stable after release.

[0030] 7. The skirt structure expands toward the outside of the stent body, which can enlarge the clamping area of the skirt structure and the anchoring structure on the native valve leaflet, making the artificial valve anchoring more stable.

[0031] 8. A reinforcement structure is connected between two adjacent anchoring rods. The reinforcement structure can further improve the strength and stability of the anchoring rods, effectively prevent the displacement of the anchoring rods, avoid the displacement of the transcatheter replacement valve and affect the clamping stability with the native valve ring, and avoid paravalvular leakage. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the specific embodiments or the description of the prior art. Obviously, the drawings described below are some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0033] Figure 1 A schematic structural diagram of a transcatheter valve replacement stent provided in Example 1 of the present invention is shown;

[0034] Figure 2 Shown Figure 1 Front view of

[0035] Figure 3 Shown Figure 1 A top view of

[0036] Figure 4 Shown Figure 1 Schematic diagram of the structure of the middle bracket body;

[0037] Figure 5 Shown Figure 4 Front view of

[0038] Figure 6 Shown Figure 1 Schematic diagram of the structure of the anchoring structure;

[0039] Figure 7 Shown Figure 6 Front view of

[0040] Figure 8 Shown Figure 6 A top view of

[0041] Figure 9 A schematic diagram of the structure of the transcatheter valve replacement stent provided in Example 1 of the present invention clamping the native valve leaflet after release is shown;

[0042] Figure 10 A schematic structural diagram of a transcatheter valve replacement stent provided by Example 2 of the present invention is shown;

[0043] Figure 11 Shown Figure 10 Schematic diagram of the structure of the anchoring structure;

[0044] Figure 12 Shown Figure 11 Front view of

[0045] Figure 13 Shown Figure 11 A top view of

[0046] Figure 14 A schematic structural diagram of a transcatheter valve replacement stent provided by Example 3 of the present invention is shown;

[0047] Figure 15 Shown Figure 14 Schematic diagram of the structure of the anchoring structure;

[0048] Figure 16 Shown Figure 15 A top view of

[0049] Figure 17 A schematic structural diagram of a transcatheter valve replacement stent provided by Example 4 of the present invention is shown;

[0050] Figure 18 Shown Figure 17 Schematic diagram of the structure of the anchoring structure;

[0051] Figure 19 Shown Figure 18 A top view of

[0052] Figure 20 A schematic structural diagram of a transcatheter valve replacement stent provided by Example 5 of the present invention is shown;

[0053] Figure 21 Shown Figure 20 Schematic diagram of the structure of the anchoring structure;

[0054] Figure 22 Shown Figure 21 A top view of

[0055] Figure 23 A schematic structural diagram of a sealing skirt in a transcatheter valve replacement according to an embodiment of the present invention is shown;

[0056] Figure 24 Another structural schematic diagram of a sealing skirt in a transcatheter valve replacement according to an embodiment of the present invention is shown;

[0057] Figure 25 Shown Figure 22 A schematic structural diagram of the sutured state of the middle sealing skirt and the bracket body;

[0058] Figure 26 A bottom view of the structure of a transcatheter valve replacement provided by Example 6 of the present invention is shown;

[0059] Figure 27 A schematic structural diagram of a transcatheter valve replacement during delivery provided by an embodiment of the present invention is shown.

[0060] Description of reference numerals:

[0061] 1. Stent body; 11. Leaflet suture ear; 2. Anchoring structure; 21. Anchoring member; 211. Anchoring rod; 2111. First rod segment; 2111A. First bending part; 2111B. Second bending part; 2112. Second rod segment; 2113. Middle rod segment; 3. Skirt structure; 31. First skirt segment; 32. Second skirt segment; 33. Mesh opening; 4. Reinforcement structure; 41. Reinforcement rod; 5. Delivery connection structure; 51. Connecting rod; 52. Hanging part; 6. Sealing skirt; 61. Triangular extension segment; 7. Artificial valve; 8. Autologous leaflet; 81. Posterior cusp; 82. Anterior cusp; 9. Left atrium; 10. Left ventricle; 20. Myocardial tissue; 30. Atrial septum; 40. Bending sheath. DETAILED DESCRIPTION

[0062] The technical solution of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the embodiments described are only some embodiments of the present invention, not all embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention without making any creative efforts shall fall within the scope of protection of the present invention.

[0063] In the description of the present invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicating orientations or positional relationships, are based on the orientations or positional relationships shown in the accompanying drawings and are intended solely to facilitate and simplify the description of the present invention. They are not intended to indicate or imply that the devices or components referred to must have, be constructed, or operate in a specific orientation, and therefore should not be construed as limitations on the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0064] In the description of the present invention, it should be noted that, unless otherwise expressly specified or limited, the terms "mounted," "connected," and "connected" should be understood in a broad sense. For example, they may refer to fixed, detachable, or integral connections; mechanical or electrical connections; direct or indirect connections through an intermediate medium; and internal communication between two components. Those skilled in the art will understand the specific meanings of the above terms in the present invention based on specific circumstances.

[0065] In addition, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0066] In order to facilitate the introduction of the technical solution of the present invention, the following is a detailed description with reference to the accompanying drawings and specific embodiments, but the embodiments should not be regarded as limiting the present invention.

[0067] Example 1

[0068] A transcatheter valve replacement stent is made of nickel-titanium alloy material with shape memory function, which can be radially compressed, delivered through a catheter, and released after reaching the position, and can achieve radial self-expansion and unfolding into a prefabricated shape. Figures 1-8 The transcatheter valve replacement stent comprises a stent body 1 and an anchoring structure 2. The stent body 1 is a cylindrical frame structure that can be radially compressed and expanded. Figure 4 and Figure 5; The stent body 1 has a clamped state and an expanded state; the anchoring structure 2 is arranged around the outer periphery of the stent body 1; when the stent body 1 is in the clamped state, the anchoring structure 2 at least partially overlaps with the stent body 1 in the radial direction, so that the transcatheter valve replacement stent forms a double-layer frame structure when clamped; when the stent body 1 is in the expanded state, the anchoring structure 2 expands toward the outside of the stent body 1 to anchor the stent body 1, that is, when the transcatheter valve replacement stent is delivered to the target position, the stent body 1 is expanded and anchored by the anchoring structure 2.

[0069] By utilizing the technical solution of the present invention, since the stent body 1 is in a clamped state, the anchoring structure 2 at least partially overlaps with the stent body 1 in the radial direction. Compared with the existing replacement valve stent, the present invention can greatly shorten the length of the replacement valve stent after clamping, so that in the delivery system, the length of the bending sheath 40 occupied by the replacement valve stent is short, and the replacement valve stent can avoid large-angle bends during the release process in a narrow space, making the bending sheath 40 easier to bend and reducing the mechanical strength and performance requirements of the bending sheath 40 of the delivery system.

[0070] The transcatheter valve replacement stent provided by the present invention is suitable for aortic valve or mitral valve replacement. Here, the mitral valve replacement valve stent is taken as an example to illustrate the technical solution of the present invention.

[0071] Reference Figure 25 The delivery system includes a bending sheath 40. The transcatheter valve replacement stent carrying the artificial valve 7 is pressed and gripped and then loaded into the bending sheath 40. The bending sheath 40 passes through the atrial septum 30 from the right atrium and enters the left atrium 9. At this time, it needs to be bent approximately 90°. The head end of the bending sheath 40 is in a horizontal state when passing through the atrial septum 30. To continue moving forward and enter the left ventricle 10, it needs to be bent from horizontal to vertical, that is, the head end of the bending sheath 40 and its main body are roughly bent at 90°. This is also the area with the largest bending angle during the entire replacement operation. However, in the prior art, the axial length of the replacement valve stent after being pressed and gripped is greater than the axial length in the expanded state, the space of the left atrium 9 is small, and bending is difficult. The bending sheath 40 is loaded with the replaced valve stent after being pressed and gripped, which makes bending more difficult and requires higher mechanical strength and performance of the bending sheath 40. The present invention greatly shortens the length of the replacement valve stent after being pressed and gripped by setting the replacement valve stent as a double-layer structure, so that the replacement valve stent is located at the head end of the bending sheath 40, avoiding the maximum bending part of the bending sheath 40. Only the bending sheath 40 needs to be bent, and there is no replacement valve stent at the bending part, which greatly reduces the difficulty of bending and improves the efficiency and success rate of the replacement operation. In addition, it also reduces the mechanical strength and performance requirements of the bending sheath 40 and reduces the cost of the bending sheath 40.

[0072] Further, refer to Figures 1-8 The bracket body 1 has a first end and a second end that are arranged opposite to each other. Figure 2 From the perspective of the orientation, the first end of the bracket body 1 is the lower end, which is also the outflow end; the second end of the bracket body 1 is the upper end, which is also the inflow end.

[0073] Further, refer to Figure 6 and Figure 7 The anchoring structure 2 includes a plurality of anchoring members 21 spaced apart around the periphery of the stent body 1. The anchoring members 21 have fixed ends and free ends. The fixed ends are connected to the stent body 1. When the stent body 1 is in the deployed state, the free ends of the anchoring members 2 extend radially outward from the stent body 1, providing radial support to the stent body 1 and thereby anchoring the stent body 1. In a preferred embodiment, the fixed ends are connected to the first end of the stent body 1, and the free ends extend toward the second end of the stent body 1. When the stent body 1 is in the crimped state, at least one of the stent body 1 and the anchoring members 2 completely overlaps the other in the radial direction. This maximizes the radial overlap between the anchoring members 2 and the stent body 1, minimizing the length of the valve replacement stent after crimping. In this embodiment, because the second end of the stent body 1 is also connected to the skirt structure 3, in the crimped state, the combined axial length of the skirt structure 3 and the stent body 1 is greater than the axial length of the anchoring members 21. That is, in the crimped state, the stent body 1 completely overlaps the anchoring members 21 in the radial direction.

[0074] The multiple anchors 21 spaced apart around the periphery of the stent body 1 provide radial support around the periphery of the stent body 1, ensuring stable anchoring of the stent body 1. As a preferred embodiment, the multiple anchors 21 are evenly spaced around the periphery of the stent body 1, providing uniform support around the circumference of the stent body 1 and preventing radial displacement of the stent body 1.

[0075] Furthermore, the anchor member 21 includes an anchor rod 211, referring to Figure 6 and Figure 7The anchor rod 211 includes a first rod segment 2111, a second rod segment 2112, and an intermediate rod segment 2113 connecting the first rod segment 2111 and the second rod segment 2112; the intermediate rod segment 2113 is a bent rod, which can be compared to the shape of the letter "n" or "m". The first ends of the first rod segment 2111 and the second rod segment 2112 are connected to the first end of the bracket body 1 to form the above-mentioned fixed end, and the second ends of the first rod segment 2111 and the second rod segment 2112 extend axially toward the second end of the bracket body 1 and are connected to form a closed loop structure through the intermediate rod segment 2113. The intermediate rod segment 2113 constitutes the above-mentioned free end. The anchor rod 211 can be regarded as a rod, which is bent in the middle, and its two ends are connected to the first end of the bracket body 1 to form the above-mentioned fixed end. The bent middle part extends toward the second end of the bracket body 1 to form the above-mentioned free end.

[0076] The first rod segment 2111 and the second rod segment 2112 of the anchor rod 211 are connected to form a closed loop structure through the middle rod segment 2113, which improves the strength of the anchor rod 211 and at the same time improves the circumferential support force of the anchor rod 211 around the stent body 1. After the replacement valve stent is anchored, it is not easy to cause circumferential displacement. Compared with the structure of a single anchor rod 211 with one end connected to the stent body 1 and the other end being a free end, the replacement valve stent of the present invention is more stable; in addition, since the anchor rod 211 is a closed loop structure, compared with a single anchor rod 211, the anchor rod 211 of the present invention can more easily cross the chordae tendineae, avoiding pulling the chordae tendineae and causing unnecessary damage to the patient.

[0077] Furthermore, the outer contour of the bend of the middle rod section 2113 is a smooth arc. The outer contour here refers to the outer contour of the bend convex side.

[0078] The middle rod segment 2113, as the free end of the anchoring rod 211, directly contacts the patient's autologous valve leaflet 8 or myocardial tissue 20. The outer contour of the bending part of the middle rod segment 2113 of the anchoring rod 211 is set to a smooth arc, which can effectively prevent the anchoring structure 2 from injuring the autologous valve leaflet 8 or myocardial tissue 20 during the anchoring process, thereby causing complications.

[0079] Furthermore, among the multiple anchoring rods 211 , at least half of the intermediate rod segments 2113 are bent along the radial direction of the stent body 1 toward or away from the stent body 1 to adapt to the posterior cusp 81 of the mitral valve.

[0080] Among the multiple anchoring rods 211, at least half of the intermediate rod segments 2113 are bent radially toward or away from the stent body 1. This differentiated arrangement of the anchoring rods 211 enables the replacement valve stent to adapt to the anterior cusp 82 and posterior cusp 81 of the mitral valve, respectively, so that the transcatheter replacement valve stent can better adapt to the physiological characteristics of the mitral valve while ensuring that the myocardial tissue 20 or the native valve leaflet 8 is not injured. Specifically, the mitral valve has an anterior cusp 82 and a posterior cusp 81. Figure 9 The front tip 82 is close to the atrial septum 30, and the rear tip 81 is far away from the atrial septum 30. The rear tip 81 is connected to the myocardial tissue 20. Therefore, the anchor rod 211 near the front tip 82 does not need to consider the problem of puncturing the myocardial tissue 20, while the anchor rod 211 near the rear tip 81 needs to consider the problem of puncturing the myocardial tissue 20 and puncturing the native valve leaflet 8. In order to adapt to this physiological characteristic, as a preferred embodiment, this embodiment has a differentiated arrangement of the anchor rod 211. Figures 1-8 In this embodiment, six anchor rods 211 are provided and are evenly spaced around the stent body 1. These six anchor rods 211 are divided into two clamping groups. The first clamping group includes three anchor rods 211, and the middle rod segments 2113 of the three anchor rods 211 are not bent along the radial direction of the stent body 1 to accommodate the anterior cusp 82. The second clamping group includes another three anchor rods 211, and the middle rod segments 2113 of the three anchor rods 211 are bent along the radial direction of the stent body 1 close to the stent body 1 to accommodate the posterior cusp 81 of the mitral valve. Because the middle rod segment 2113 is a bent rod, and the outer contour of the bend is a smooth arc, puncture wounds can be avoided regardless of whether it is located at the anterior cusp 82 or the posterior cusp 81. The anchoring rod 211 of the second clamping group located at the posterior tip 81, since the middle rod section 2113 can subsequently cooperate with the skirt structure 3 to clamp the root of the autologous valve leaflet 8, the middle rod section 2113 is bent along the radial direction of the stent body 1, which can not only avoid injuring the myocardial tissue 20, but also avoid injuring the root of the autologous valve leaflet 8. In addition, after bending, the anchoring rod 211 and the skirt structure 3 cooperate to increase the area of clamping the autologous valve leaflet 8, which is beneficial to further improve the anchoring stability of the stent body 1.

[0081] Specifically, refer to Figure 7 or Figure 12The first rod segment 2111 includes a first bend portion 2111A and a second bend portion 2111B arranged sequentially from the first end to the second end. The first bend portion 2111A is convexly curved radially close to the stent body 1, and the second bend portion 2111B is convexly curved radially away from the stent body 1. When the stent body 1 is deployed, the anchor rod 211 and the stent body 1 can clamp the native leaflet 8. Because the first bend portion 2111A and the second bend portion 2111B are bent in opposite directions, the anchor rod 211 has an elastic force toward one side of the stent body 1, which enhances the clamping force between the anchor rod 211 and the stent body 1, further clamping the native leaflet 8 and firmly anchoring the stent body 1. In this embodiment, the first rod segment 2111 and the second rod segment 2112 have the same structure.

[0082] Furthermore, the transcatheter valve replacement stent also includes a skirt structure 3, which is arranged around the outer periphery of the stent body 1. When the stent body 1 is in the expanded state, the skirt structure 3 expands toward the outside of the stent body 1 and cooperates with the anchoring structure 2 that also expands outward to form a clamping mechanism for clamping the autologous valve leaflet 8.

[0083] Compared to technical solutions that simply rely on the anchoring structure 2 to provide radial support to anchor the stent body 1, the present invention can clamp the native valve leaflets 8 through the coordination of the anchoring structure 2 and the skirt structure 3, and the clamping is stable, ensuring that the stent body 1 is not easily displaced along the axial and circumferential directions of the stent body 1, thereby avoiding paravalvular leakage or other complications. In addition, after the transcatheter replacement valve is released, because the skirt structure 3 is located on the atrial side of the native valve leaflets 8 and the anchoring structure 2 is located on the ventricular side, it can clamp the roots of the native valve leaflets 8, resulting in a better clamping effect. In particular, during cardiac contraction, the anchoring structure 2 and the skirt structure 3 clamp more tightly, making the anchoring of the transcatheter replacement valve more stable after release.

[0084] Specifically, the skirt structure 3 is an annular frame structure, the inner circle of the skirt structure 3 is connected to the second end of the bracket body 1 , and the outer circle of the skirt structure 3 extends toward the outside of the bracket body 1 .

[0085] The outer diameter of the skirt structure 3 is larger than the diameter of the stent body 1. After the transcatheter valve replacement stent is released, the skirt structure 3 is located in the left atrium 9, above the patient's native valve leaflets 8. The skirt structure 3 expands outward from the stent body 1, increasing the area of ​​the support structure 3 and the anchoring structure 2 that grip the native valve leaflets 8, thus ensuring a more stable anchoring of the stent body 1.

[0086] Further, refer to Figure 4The skirt structure 3 includes a first skirt section 31 connected to the bracket body 1 and a second skirt section 32 connected to the first skirt section 31. The first skirt section 31 is bent away from the bracket body 1 along the radial direction of the bracket body 1, and the second skirt section 32 is bent close to the bracket body 1 along the radial direction of the bracket body 1.

[0087] As a preferred embodiment, the first support section 31 is smoothly connected to the support body 1, and the first support section 31 and the second support section 32 are smoothly connected. The support structure 3 can be vividly regarded as a disc-shaped mesh support, such as Figure 1 、 Figure 4 or Figure 5 As shown. The skirt structure 3 provides support for the sewing of the flexible sealing skirt 6. The sealing skirt 6 will be introduced later. Figure 4 After being bent, the second skirt section 32 can fit the myocardial tissue 20 or the atrial septum 30, thereby improving the sealing effect.

[0088] Furthermore, the skirt support structure 3 has a mesh opening 33, and the free end of the anchor 21 extends into the mesh opening 33, that is, the middle rod segment 2113 of the anchor rod 211 extends into the mesh opening 33. Specifically, there is a mesh opening 33 between the first skirt support segment 31 and the second skirt support segment 32, or between the second skirt support segment 32 and the stent body 1. The skirt support structure 3 is provided with a plurality of mesh openings 33 around the stent body 1. After the replacement valve stent is released, each mesh opening 33 corresponds to the middle rod segment 2113 of each anchor rod 211. As mentioned above, referring to Figure 9 After the transcatheter valve replacement stent is released, the support structure 3 is located in the left atrium 9, that is, above the native valve leaflets 8, and the anchor rods 211 are located in the left ventricle 10, that is, below the native valve leaflets 8. The support structure 3 and the anchor rods 211 clamp the native valve leaflets 8 therebetween. During ventricular contraction, the anchor rods 211 and the support structure 3 cooperate to clamp the native valve leaflets 8, preventing the transcatheter valve replacement from shifting and preventing paravalvular leakage.

[0089] The grid opening 33 of the skirt support structure 3 has at least two skirt support rods that can clamp the autologous leaflet 8. Compared with the solution in which the anchor rod 211 and the single skirt support rod of the skirt support structure 3 cooperate to clamp the autologous leaflet 8, the second end of the anchor rod 211 extends to the grid opening 33 of the skirt support structure 3, and there are at least two skirt support rods cooperating with the anchor rod 211 to clamp the autologous leaflet 8. The clamping area is large and the clamping is more stable, ensuring that the transcatheter replacement valve is not prone to circumferential and axial displacement along the stent body 1.

[0090] The support structure 3 is an annular frame structure, and multiple anchor rods 211 are spaced apart around the stent body 1. Thus, multiple clamping points are formed between the support structure 3 and the anchor rods 211 around the stent body 1. In this embodiment, the anchor rods 211 are evenly spaced around the stent body 1, ensuring that both the anterior cusp 82 and the posterior cusp 81 of the mitral valve are subjected to uniform clamping force, ensuring stable clamping.

[0091] In addition, the middle rod section 2113 of the anchor rod 211 is bent toward one side along the radial direction of the bracket body 1. When it cooperates with the skirt structure 3, because the anchor rod 211 has elastic deformation ability, the bent portion can provide a clamping force toward the inner side of the bracket body 1, and the first skirt section 31 is bent toward the outer side of the bracket body 1. The two are arranged relative to each other and cater to each other, thereby enhancing the clamping effect of the anchor rod 211 and the skirt structure 3, making the clamping more stable.

[0092] Furthermore, a reinforcement structure 4 is connected between two adjacent anchoring members 21 .

[0093] The reinforcement structure 4 is connected between two adjacent anchor rods 211, which can further improve the strength and stability of the anchor rods 211, effectively prevent the deviation of the anchor rods 211, avoid the displacement of the transcatheter valve replacement stent and affect the clamping stability with the native valve ring, and ensure the uniform distribution and lateral stability of each anchor rod 211. Figure 2 From the perspective of orientation, it can also be said to be horizontal stability, which prevents the stent body 1 from circumferential displacement and paravalvular leakage.

[0094] Furthermore, the reinforcement structure 4 includes a reinforcement rod 41, and the reinforcement rod 41 is a combination of one or more of V-shape, U-shape, and W-shape, and the two ends of the reinforcement rod 41 are respectively connected to two adjacent anchors 21. Specifically, in this embodiment, the reinforcement rod 41 is V-shaped, and one end of the reinforcement rod 41 is connected to the first rod segment 2111 of one anchor rod 211, and the other end of the reinforcement rod 41 is connected to the second rod segment 2112 of another anchor rod 211. The reinforcement rod 41 and the bracket body 1 are fitted together and connected by sutures, and the sutures are omitted in the accompanying drawings. V-shape, U-shape, and W-shape refer to the shapes of the reinforcement rod 41. Since the reinforcement rod 41 and the bracket body 1 are sutured and connected, the setting direction of the reinforcement rod 41 is not limited. Taking the V-shaped reinforcement rod 41 as an example, in this embodiment, the tip of the V-shaped reinforcement rod 41 is facing the second end of the bracket body 1. Figure 7From the perspective of the orientation, the tip of the V-shaped reinforcing rod 41 points downward. Of course, in some other embodiments, the tip of the V-shaped reinforcing rod 41 can be set upward. Moreover, the connection position of the reinforcing rod 41 is not limited to the first end of the stent body 1, but can also be located in the middle of the stent body 1. In this case, in order not to affect the deployment of the anchor rod 211, the reinforcing rod 41 can be disconnected from the stent body 1. The reinforcing rod 41 connects the multiple anchor members 21 into a closed frame, further improving the circumferential stability of the anchor structure 2.

[0095] Furthermore, the second end of the stent body 1 is provided with a delivery connection structure 5, which includes a plurality of connecting rods 51 arranged at intervals around the stent body 1. One end of the connecting rod 51 is connected to the second end of the stent body 1, and the other end of the connecting rod 51 extends away from the second end of the stent body 1 along the axial direction of the stent body 1, and a hanging portion 52 is provided at the end. The hanging portion 52 is suitable for connecting to the delivery system. The hanging portion 52 protrudes from the connecting rod 5171, which is beneficial for providing a fulcrum when the stent body 1 is connected to the delivery system. At the same time, it can prevent the skirt structure 3 from generating impact force during the release process, causing the anchor 21 to shift or even cause heart damage. In this embodiment, six connecting rods 51 are provided, and are evenly spaced around the stent body 1. The hanging portion 52 is a horizontal rod arranged perpendicular to the connecting rod 51. Of course, the hanging portion 52 can also be a ring or other structure protruding from the connecting rod 51.

[0096] Furthermore, the stent body 1 is provided with a plurality of leaflet suturing ears 11 around the stent body 1. The leaflet suturing ears 11 are suturing holes provided on the stent body 1, which provide support for suturing the artificial valve 7 made of biological or non-biological flexible materials.

[0097] Example 2

[0098] This embodiment provides a modified implementation method, referring to Figure 10-13 The difference from Example 1 is that the middle rod segments 2113 of the three anchor rods 211 of the second clamping group are bent away from the stent body 1 .

[0099] Example 3

[0100] This embodiment provides a modified implementation method, referring to Figure 14-16 The difference from Example 2 is that 12 anchor rods 211 are arranged around the stent body 1, with 6 anchor rods in each of the first clamping group and the second clamping group.

[0101] Example 4

[0102] This embodiment provides a modified implementation method, referring to Figure 17-Figure 19The difference from Example 2 is that it does not distinguish between the front tip 82 and the rear tip 81 , and there are a total of 6 anchor rods 211 , and the middle rod sections 2113 of the 6 anchor rods 211 are all bent away from the stent body 1 .

[0103] Example 5

[0104] This embodiment provides a modified implementation method, referring to Figure 20-22 The difference from Example 4 is that 12 anchor rods 211 are evenly spaced around the outer circumference of the stent body 1.

[0105] Of course, the anchoring structure 2 is not limited to the structures of the above five embodiments.

[0106] Example 6

[0107] This embodiment provides a transcatheter valve replacement device, including the transcatheter valve replacement stent described in any one of Examples 1 to 5.

[0108] Furthermore, in this embodiment, a sealing skirt cloth 6 is connected to the skirt structure 3. The structure of the sealing skirt cloth 6 is as follows: Figure 23 In this embodiment, the sealing skirt 6 is a PET mesh. The sealing skirt 6 surrounds the stent body 1 and is tightly mounted on the inner side of the stent body 1. The first end of the sealing skirt 6 is connected to the skirt structure 3, and the second end of the sealing skirt 6 extends toward the first end of the stent body 1.

[0109] Furthermore, as a modified embodiment, Figure 24 As shown, the sealing skirt 6 can also be provided with a triangular extension section 61 at the second end of the sealing skirt 6 to provide a higher sealing effect. The position where the sealing skirt 6 is sewn to the bracket body 1 is as shown in FIG. Figure 25 As shown, in this embodiment, the bracket body 1 is a diamond grid structure, and the triangular extension section 61 of the sealing skirt 6 is adapted to the triangular window exposed by the diamond grid of the bracket body 1.

[0110] Furthermore, the transcatheter valve replacement stent further includes a leaflet suture ear 11, and the second end of the sealing skirt 6 partially or completely covers the leaflet suture ear 11, which can effectively enhance the sealing effect and prevent paravalvular leakage.

[0111] Furthermore, the inner side of the stent body 1 is sutured and connected to the artificial valve 7 at the valve leaflet suture ear 11; the artificial valve 7 has two pieces, suitable for replacing the patient's mitral valve; or, the artificial valve 7 has three pieces, refer to Figure 26 , suitable for replacing the patient's aortic valve; or, the artificial valve 7 has four pieces, suitable for the heart valve of special patients.

[0112] A percutaneous catheter is a catheter that is inserted through the skin with a needle. All catheters are hollow tubes that allow fluids to enter the body or allow excess fluids to be removed from the body through the catheter and into a suitable disposal container.

[0113] A method for using a transcatheter mitral valve replacement device comprises the following steps:

[0114] Step S1: Puncture one femoral vein of the patient, insert the guide wire and puncture sheath into the right atrium, puncture the atrial septum 30, and enter the left ventricle 10 through the mitral valve;

[0115] Step S2: loading the transcatheter valve replacement device into a corresponding delivery system, and delivering the delivery system into the left ventricle 10 along the guidewire track;

[0116] Step S3: Using the markings on the delivery system, adjust the delivery system direction so that the second clamping group of the anchoring rod 211 is turned toward the posterior leaflet of the mitral valve. Release the anchoring rod 211 and adjust the position so that the anchoring rod 211 of the second clamping group is pushed toward the root of the posterior leaflet, and the anchoring rod 211 of the first clamping group is pushed toward the root of the anterior leaflet of the mitral valve. Continue to release the leaflet suture ears 11 and the skirt structure 3 at the atrial end so that the skirt structure 3 is supported at the bottom of the atrium. Finally, release the delivery connection structure 5.

[0117] Step S4: withdraw the delivery system for the mitral valve intervention to the right atrium, insert the atrial septum 30 occluder, occlude the atrial septum 30, and complete the operation.

[0118] In the above steps, the three steps of positioning, fixation, and release are completed by unidirectional withdrawal of the sheath, which effectively reduces the radial size of the delivery system and reduces the pressure and damage of the head end of the delivery system on the ventricular septum.

[0119] The surgical procedure involves puncturing the femoral vein through the atrial septum (30°), puncturing the ventricular septum, establishing a guidewire track from the left ventricle (10°) to the right ventricle, advancing the interventional transcatheter valve replacement device along the guidewire, releasing the anchor rod (211), withdrawing the sheath, and releasing the prosthetic valve (7). The atrial septum (30°) is then blocked, and the procedure is complete.

[0120] According to the above description, this patent application has the following advantages:

[0121] 1. The present invention can shorten the length of the replacement valve stent after being pressed and gripped, and the length of the bending adjustment sheath 40 occupied is short, so that the replacement valve stent can avoid large-angle bends during the release process in a narrow space, making it easier to bend the bending adjustment sheath 40;

[0122] 2. The anchor rod 211 is connected to the stent body 1 to form a closed loop structure, which improves the strength of the anchor rod 211 and provides circumferential support for the stent body 1, making it less likely for the replacement valve stent to move circumferentially after anchoring, and making the anchoring more stable;

[0123] 3. The free end of the anchoring rod 211 is a smooth structure, which can effectively prevent the anchoring structure 2 from causing complications due to puncturing the native valve leaflet 8 or myocardial tissue 20 during the anchoring process;

[0124] 4. The anchor rod 211 is differentially arranged to accommodate the front tip 82 and the rear tip 81 to ensure that the myocardial tissue 20 or the native valve leaflet 8 is not injured;

[0125] 5. The anchoring structure 2 cooperates with the skirt structure 3 to clamp the native valve leaflets 8, and can clamp the roots of the native valve leaflets 8 stably, which can ensure that the artificial valve 7 does not shift, avoiding paravalvular leakage or other complications;

[0126] 6. The reinforcement structure 4 can further improve the strength and stability of the anchor rod 211, effectively prevent the anchor rod 211 from deviating, avoid the displacement of the transcatheter replacement valve and affect the clamping stability with the native valve ring, and avoid paravalvular leakage.

[0127] Obviously, the above embodiments are merely examples for clarity of explanation and are not intended to limit the implementation methods. Those skilled in the art will readily appreciate that other variations or modifications based on the above descriptions are possible. It is not necessary and impossible to enumerate all implementation methods here. Obvious variations or modifications arising therefrom remain within the scope of protection of the present invention.

Claims

1. A transcatheter valve replacement stent, characterized in that: include: The stent body (1) is a cylindrical frame structure that can be radially compressed and expanded, and has a compressed state and an expanded state; An anchoring structure (2), the anchoring structure (2) is arranged around the outer periphery of the stent body (1); when the stent body (1) is in the pressed and gripped state, the anchoring structure (2) at least partially overlaps with the stent body (1) in the radial direction, so that the transcatheter valve replacement stent forms a double-layer frame structure when pressed and gripped; when the stent body (1) is in the expanded state, the anchoring structure (2) expands toward the outside of the stent body (1) to anchor the stent body (1); The anchoring structure (2) comprises a plurality of anchoring members (21) arranged at intervals around the outer periphery of the stent body (1), the anchoring members (21) being provided with a fixed end and a free end, the fixed end being connected to the stent body (1); when the stent body (1) is in an expanded state, the free end is extended outwardly in the radial direction of the stent body (1), and is suitable for providing a radial anchoring force for the stent body (1); The anchoring member (21) comprises an anchoring rod (211), and the anchoring rod (211) comprises a first rod segment (2111), a second rod segment (2112), and an intermediate rod segment (2113) connecting the first rod segment (2111) and the second rod segment (2112); the intermediate rod segment (2113) is a bent rod, and the first ends of the first rod segment (2111) and the second rod segment (2112) are connected to the bracket body (1) to form the fixed end, and the second ends of the first rod segment (2111) and the second rod segment (2112) extend along the axial direction of the bracket body (1) and are connected to form a closed loop structure through the intermediate rod segment (2113), and the intermediate rod segment (2113) forms the free end; It also includes a skirt structure (3), which is arranged around the outer periphery of the stent body (1). When the stent body (1) is in the expanded state, the anchoring structure (2) cooperates with the skirt structure (3) to clamp the autologous valve leaflet (8); The skirt support structure (3) is an annular frame structure, the inner ring of the skirt support structure (3) is connected to the second end of the support body (1), and the outer ring of the skirt support structure (3) extends toward the outside of the support body (1); The skirt support structure (3) comprises a first skirt support section (31) connected to the support body (1) and a second skirt support section (32) connected to the first skirt support section (31), wherein the first skirt support section (31) is bent away from the support body (1) along the radial direction of the support body (1), and the second skirt support section (32) is bent close to the support body (1) along the radial direction of the support body (1); A mesh opening (33) is provided between the first skirt section (31) and the bracket body (1) or between the first skirt section (31) and the second skirt section (32), and the free end extends into the mesh opening (33); The skirt structure (3) is provided with a plurality of grid openings (33) around the bracket body (1); after the bracket body (1) is released, each grid opening (33) corresponds to the middle rod section (2113) of each anchor rod (211).

2. The transcatheter valve replacement stent according to claim 1, characterized in that: The outer contour of the bending portion of the middle rod section (2113) is a smooth arc.

3. The transcatheter valve replacement stent according to claim 1, characterized in that: Among the plurality of anchoring rods (211), at least half of the intermediate rod segments (2113) are bent radially toward or away from the stent body (1) to prevent myocardial tissue (20) from being injured.

4. The transcatheter valve replacement stent according to claim 1, characterized in that: The first rod segment (2111) comprises a first bending portion (2111A) and a second bending portion (2111B) arranged in sequence from the first end to the second end, the first bending portion (2111A) convexly bends radially close to the bracket body (1), and the second bending portion (2111B) convexly bends radially away from the bracket body (1); the second rod segment (2112) has the same structure as the first rod segment (2111).

5. The transcatheter valve replacement stent according to any one of claims 1 to 4, characterized in that: The fixed end is connected to the first end of the stent body (1), and the free end extends toward the second end of the stent body (1), so that when the stent body (1) is in a pressed state, at least one of the stent body (1) and the anchoring structure (2) completely overlaps with the other in the radial direction.

6. The transcatheter valve replacement stent according to any one of claims 1 to 4, characterized in that: A reinforcement structure (4) is connected between two adjacent anchoring members (21).

7. The transcatheter valve replacement stent according to claim 6, characterized in that: The reinforcement structure (4) comprises a reinforcement rod (41), wherein the reinforcement rod (41) is a combination of one or more of a V-shape, a U-shape, and a W-shape, and both ends of the reinforcement rod (41) are respectively connected to two adjacent anchoring members (21).

8. The transcatheter valve replacement stent according to any one of claims 1 to 4, characterized in that: The second end of the bracket body (1) is provided with a conveying connection structure (5), and the conveying connection structure (5) includes a plurality of connecting rods (51) arranged at intervals around the bracket body (1), one end of the connecting rod (51) is connected to the second end of the bracket body (1), and the other end of the connecting rod (51) extends away from the second end of the bracket body (1) along the axial direction of the bracket body (1), and a hanging part (52) is provided at the end, and the hanging part (52) is suitable for connecting with a conveying system.

9. The transcatheter valve replacement stent according to any one of claims 1 to 4, characterized in that: The stent body (1) is provided with a plurality of leaflet suture ears (11) around the stent body (1).

10. A transcatheter valve replacement device, characterized in that: The invention comprises the transcatheter valve replacement stent according to any one of claims 1 to 9.

11. The transcatheter valve replacement device according to claim 10, wherein: The support body (1) has a skirt structure (3), and a sealing skirt cloth (6) is connected to the skirt structure (3). The sealing skirt cloth (6) surrounds the support body (1) and is arranged on the inner side of the support body (1) in a close fit. The first end of the sealing skirt cloth (6) is connected to the skirt structure (3), and the second end of the sealing skirt cloth (6) extends toward the first end of the support body (1).

12. The transcatheter valve replacement device according to claim 11, wherein: The transcatheter replacement valve stent further comprises a leaflet suture ear (11), and the second end of the sealing skirt (6) partially or completely covers the leaflet suture ear (11).

13. The transcatheter valve replacement device according to any one of claims 10 to 12, characterized in that: The transcatheter valve replacement stent further comprises a leaflet suturing ear (11), and an artificial valve (7) is sutured and connected to the inner side of the stent body (1) at the leaflet suturing ear (11); the artificial valve (7) is provided with two pieces, suitable for replacing the patient's mitral valve; or, the artificial valve (7) is provided with three pieces, suitable for replacing the patient's aortic valve; or, the artificial valve (7) is provided with four pieces, suitable for the heart valve of special patients.

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