Transcatheter replacement valve device and its stent

Abstract

The application provides a kind of replacement valve device and support by catheterization, it is related to heart valve technical field.The replacement valve support by catheterization includes support main body and anchoring structure.The support main body is the cylinder frame structure that can be radially compressed and unfolded, with the state of pressing and unfolding state;The anchoring structure is the closed frame structure that is set around the outer periphery of support main body;When support main body is in the unfolded state, anchoring structure expands towards the outside of support main body, so that support main body is anchored.The application can solve the problem of insufficient anchoring force, anchoring part deviation in prior art, leading to artificial valve displacement, unable to guarantee the fit of artificial valve ring and autologous valve ring, thereby leading to perivalvular leakage or causing other complications, the closed frame structure exists mutual force, can provide more stable support force for support main body, effectively prevent the circumferential displacement of support main body.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of heart valve, in particular to a transcatheter replacement valve device and a stent. BACKGROUND

[0002] Transcatheter mitral valve replacement (TMVR) does not require thoracotomy, cardiopulmonary bypass or cardioplegia, greatly reducing surgical trauma, and has become another research hotspot after transcatheter aortic valve replacement (TAVR). Most existing transcatheter mitral valve replacement systems rely on radial support force to anchor or clamp artificial valves, and provide radial support force through multiple anchors to anchor in the aortic valve or mitral valve, but the anchoring force is insufficient, the anchors are offset, which leads to displacement of the artificial valve, and cannot guarantee the coaxiality of the artificial valve ring and the autologous valve ring, thereby causing paravalvular leakage or other complications. Therefore, it is necessary to provide a transcatheter replacement valve device capable of stable anchoring. SUMMARY

[0003] Therefore, the technical problem to be solved by the present application is to overcome the defects of the prior art, i.e., the anchors damage the myocardium, the anchors are unstable in the circumferential direction and are offset, and the insufficient anchoring force leads to displacement of the artificial valve, so as to provide a transcatheter replacement valve device and a stent.

[0004] To solve the above problems, the present application provides a transcatheter replacement valve stent, which comprises 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 compressed state and an expanded state. The anchoring structure is a closed frame structure arranged around the outer periphery of the stent body. When the stent body is in the expanded state, the anchoring structure expands towards the outside of the stent body to anchor the stent body.

[0005] Optionally, the anchoring structure comprises a plurality of anchors, the anchors are arranged around the outer periphery of the stent body, and the anchors have at least two connecting portions. The anchors are connected to the stent body through the connecting portions, and the adjacent two connecting portions are connected through a support portion. When the stent body is in the expanded state, the support portion expands towards the outside of the stent body to anchor the stent body.

[0006] Optionally, the support portion has a bending structure.

[0007] Optionally, the outer contour of the bending structure is a smooth curve.

[0008] Optionally, the anchor has a first connecting portion and a second connecting portion, the bending structure comprises a first bending segment connected to the first connecting portion and a second bending segment connected to the second connecting portion, and the first bending segment and the second bending segment have a relative torsion angle therebetween, so that the anchoring structure forms a spiral closed frame structure.

[0009] Optionally, the relative torsion angle of the first bending section and the second bending section is 45°-135°.

[0010] Optionally, the relative torsion angle of the first bending section and the second bending section is 90°.

[0011] Optionally, the anchor includes an anchor rod, two ends of the anchor rod are connected parts, a middle part of the anchor rod is bent to form a support part, the connected parts of the anchor rod are connected with the first end of the stent main body, and the support part of the anchor rod extends towards the second end of the stent main body when the stent main body is in the unfolded state.

[0012] Optionally, the anchor structure is connected with the first end of the stent main body, and the anchor structure does not overlap with the stent main body in the radial direction of the stent main body when the stent main body is in the compressed state.

[0013] Optionally, the skirt support structure is further provided on the stent main body, the skirt support structure surrounds the stent main body and extends towards the outside of the stent main body, the skirt support structure and the anchor structure form a clamping mechanism when the stent main body is in the unfolded state, and the clamping mechanism is suitable for clamping the native valve leaflet.

[0014] Optionally, the skirt support structure includes a first skirt support section connected with the stent main body and a second skirt support section connected with the first skirt support section, the first skirt support section is outwardly curved, and the second skirt support section is inwardly curved.

[0015] Optionally, the support part cooperates with the second skirt support section of the skirt support structure and is suitable for clamping the native valve leaflet.

[0016] Optionally, a reinforcing structure is connected between the two adjacent anchors.

[0017] Optionally, the reinforcing structure includes a reinforcing rod, the reinforcing rod is one or a combination of V-shaped, U-shaped and W-shaped, and two ends of the reinforcing rod are respectively connected with the two adjacent anchors.

[0018] Optionally, the second end of the stent main body is provided with a delivery connection structure, the delivery connection structure includes a plurality of connection rods arranged around the stent main body, one end of the connection rod is connected with the second end of the stent main body, the other end of the connection rod extends away from the second end of the stent main body along the axial direction of the stent main body, and a hanging part is arranged at the end part, and the hanging part is suitable for being connected with a delivery system.

[0019] Optionally, a plurality of valve suture ears are arranged around the stent main body.

[0020] Another aspect of the present application provides a transcatheter replacement valve device, which includes the transcatheter replacement valve stent in any of the above technical solutions.

[0021] Optionally, the transcatheter replacement valve stent comprises a skirt support structure, a sealing skirt is connected to the skirt support structure, the sealing skirt is arranged on the inner side of the stent body in a circle and is attached to the stent body, the first end of the sealing skirt is connected to the skirt support structure, and the second end of the sealing skirt extends towards the first end of the stent body.

[0022] Optionally, the transcatheter replacement valve stent further comprises a leaflet sewing ear, and the second end of the sealing skirt partially or completely covers the leaflet sewing ear.

[0023] Optionally, the transcatheter replacement valve stent further comprises a leaflet sewing ear, and the inner side of the stent body is connected to the artificial valve through the leaflet sewing ear; the artificial valve is provided with two pieces, which is suitable for replacing the mitral valve of a patient; or the artificial valve is provided with three pieces, which is suitable for replacing the aortic valve of a patient; in some special medical conditions, the artificial valve can also be provided with four pieces.

[0024] The present application has the following advantages:

[0025] 1. By using the technical scheme of the present application, because the anchor structure is a closed frame structure arranged around the outer periphery of the stent body, compared with the existing multiple independent anchor rods, the transcatheter replacement valve stent can provide more stable anchoring force after being released, the closed frame structure has mutual force, which can provide more stable support force for the stent body, effectively preventing the stent body from being displaced in the circumferential direction.

[0026] 2. The plurality of anchor members arranged on the outer periphery of the stent body can provide more balanced anchoring force to the outer periphery of the stent body. The support portion of the anchor member can provide radial support force to the stent body to anchor the stent body.

[0027] 3. The middle part of the anchor rod is provided with a bending structure, and both ends of the anchor rod are connected to the stent body. Compared with the single anchor rod scheme in which one end is connected to the stent body and the other end is a free end, the present application has better support force and stability, which can prevent the stent body from being displaced in the circumferential direction.

[0028] 4. The relative torsion angle exists between the first bending section and the second bending section of the bending structure, so that there is a strong mutual force between the first bending section and the second bending section. When the stent body is released and subjected to external force, the stent body tends to be displaced in the circumferential direction. Because of the mutual force between the first bending section and the second bending section, the first bending section and the second bending section restrict each other, maintain the fixed position of the stent body, ensure the attachment of the stent body and the self-valve leaflet, and prevent the stent body from being displaced in the circumferential direction.

[0029] 5. The anchor structure and the skirt support structure constitute a clamping mechanism, which can clamp the self-valve leaflet, so that the anchoring of the stent body is more stable, and further prevents the stent body from being displaced in the axial direction.

[0030] 6. The reinforcing structure is connected between the adjacent anchoring members, which can further improve the stability of the anchoring structure and further prevent the stent body from circumferential deviation.

[0031] 7. In the crimped state of the stent body, the anchoring structure does not overlap with the stent body, which can reduce the radial size of the transcatheter replacement valve stent in the crimped state, facilitate the delivery, and solve the problem of large diameter of the delivery system. BRIEF DESCRIPTION OF DRAWINGS

[0032] In order to more clearly illustrate the technical solutions in the specific embodiments or prior art of the present application, the drawings needed in the description of the specific embodiments or prior art will be briefly introduced. Obviously, the drawings in the following description are some embodiments of the present application, and other drawings can be obtained by those skilled in the art without creative labor.

[0033] Figure 1 A structure schematic diagram of a transcatheter replacement valve stent provided by the embodiment 1 of the present application is shown;

[0034] Figure 2 A front view of Figure 1 is shown;

[0035] Figure 3 A top view of Figure 1 is shown;

[0036] Figure 4 A structure schematic diagram of the transcatheter replacement valve stent in Figure 1 with the anchoring structure removed is shown;

[0037] Figure 5 A front view of Figure 4 is shown;

[0038] Figure 6 A structure schematic diagram of the anchoring structure in Figure 1 is shown;

[0039] Figure 7 A bottom view of Figure 6 is shown;

[0040] Figure 8 Two structure schematic diagrams of the anchoring structure in the crimped state and the expanded state are shown;

[0041] Figure 9 A structure schematic diagram of the transcatheter replacement valve stent provided by the embodiment 1 of the present application is shown;

[0042] Figure 10Fig. 2 shows a schematic view of a structure of the sealing skirt in Embodiment 2;

[0043] Figure 11 Fig. 3 shows a schematic view of another structure of the sealing skirt in Embodiment 3;

[0044] Figure 12 Fig. 4 shows a schematic view of the sealing skirt in Embodiment 3 in a state of being sewn with the stent body.

[0045] Legend of reference signs:

[0046] 1, stent body; 2, anchoring structure; 20, anchor; 21, connecting part; 211, first connecting part; 212, second connecting part; 22, support part; 220, bending structure; 221, first bending section; 222, second bending section; 200, anchor rod; 3, skirt support structure; 31, first skirt support section; 32, second skirt support section; 4, reinforcing structure; 41, reinforcing rod; 5, delivery connecting structure; 51, connecting rod; 52, hanging part; 6, leaflet sewing ear; 7, sealing skirt; 71, triangular extension section; 8, prosthetic valve; 9, autologous leaflet; 91, front tip; 92, rear tip; 10, myocardial tissue; 11, atrial septum; 12, left atrium; 13, left ventricle. DETAILED DESCRIPTION

[0047] The technical solutions of the present application will be described clearly and completely below in conjunction with the drawings. Obviously, the described embodiments are only some of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative work fall within the scope of protection of the present application.

[0048] In the description of the present application, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", and the like indicate the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as a limitation on the present application. In addition, the terms "first", "second", "third" are only for descriptive purposes and cannot be understood as indicating or implying relative importance.

[0049] In the description of the present application, it should be noted that unless otherwise explicitly specified and limited, the terms "mounting", "connection", "connecting" should be understood in a broad sense, for example, can be fixed connection, can also be detachable connection, or integrally connected, can be mechanical connection, can also be electrical connection, can be directly connected, can also be indirectly connected through an intermediate medium, and can be internal communication of two elements. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0050] In addition, the technical features involved in the different embodiments of the application described below can be combined with each other as long as there is no conflict between them.

[0051] In order to facilitate the introduction of the technical scheme of the present application, the following will be described in detail in combination with the drawings and specific embodiments, but the embodiments should not be regarded as limiting the present application.

[0052] Embodiment 1

[0053] A transcatheter replacement valve stent is made of a nickel-titanium alloy material with shape memory function, which can be radially compressed, transported through a catheter, released after reaching the position, and can realize radial self-expanding expansion into a prefabricated shape. The transcatheter replacement valve stent, referring to Figures 1-9 , includes 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, and has a compressed state and an expanded state. The anchoring structure 2 is a closed frame structure arranged around the outer periphery of the stent body 1. When the stent body 1 is in the expanded state, the anchoring structure 2 expands towards the outside of the stent body 1 to anchor the stent body 1.

[0054] By using the technical scheme of the present application, because the anchoring structure 2 is a closed frame structure arranged around the outer periphery of the stent body 1, compared with the existing multiple independent anchoring rods 200, after the transcatheter replacement valve stent is released, it can provide more stable anchoring force, the closed frame structure has mutual force, the overall strength is high, and it can provide more stable support force for the stent body 1, effectively preventing the stent body 1 from moving circumferentially.

[0055] The transcatheter replacement valve stent provided by the present application is suitable for aortic valve or mitral valve replacement. Here, the technical scheme of the present application is illustrated by taking a mitral valve replacement valve stent as an example.

[0056] Further, the anchoring structure 2 includes a plurality of anchoring members 20, referring to Figure 6, the anchor 20 is arranged around the outer periphery of the stent body 1, the anchor 20 has at least two connecting portions 21, the anchor 20 is connected with the stent body 1 through the connecting portions 21, and the support portions 22 are connected between the two adjacent connecting portions 21; when the stent body 1 is in the expanded state, the support portions 22 expand towards the outer side of the stent body 1, and the radial support force is provided to anchor the stent body 1. When the stent body 1 is in the expanded state, the anchor 20 is released from the outer periphery of the stent body 1 and expands outward, and the anchor 20 can provide the radial anchoring force to the stent body 1, so that the stent body 1 is fixed. As a preferred embodiment, a plurality of anchors 20 are arranged on the stent body 1 in a head-to-tail manner, or a plurality of anchors 20 are uniformly arranged on the stent body 1, when the anchors 20 are arranged at intervals, the anchors 20 are connected with the stent body 1 to form a closed loop frame structure. The plurality of anchors 20 can provide more balanced anchoring force to the outer periphery of the stent body 1, so that the anterior cusp 91 and the posterior cusp 92 of the mitral valve can be uniformly clamped, and the clamping stability is ensured.

[0057] Further, in the embodiment, the anchor 20 comprises an anchor rod 200, as shown in 6-2 of Figure 1 、 Figure 6 and Figure 7 , Figure 6 and 7-2 of Figure 7 , which is a structural schematic diagram of a single anchor rod 200. The two ends of the anchor rod 200 are the connecting portions 21, the middle part of the anchor rod 200 is bent to form the support portion 22, the connecting portion 21 of the anchor rod 200 is connected with the first end of the stent body 1, and the support portion 22 of the anchor rod 200 extends towards the second end of the stent body 1 when the stent body 1 is in the expanded state.

[0058] Specifically, as viewed from the direction of Figure 2 , the stent body 1 has oppositely arranged first and second ends, the first end of the stent body 1 is also the lower end of Figure 2 , which is also the outflow end, and the second end of the stent body 1 is also the upper end of Figure 2 , which is also the inflow end. After the stent body 1 is released, as shown in Figure 9 , the first end of the stent body 1 is located in the left ventricle 13, and the second end of the stent body 1 is located in the left atrium 12.

[0059] Further, the support portion 22 has a bending structure 220. The number of the bending structure 220 can be one or multiple. For example, when the support portion 22 is provided with one bending structure 220, the anchor rod 200 is similar to an inverted “V” type; when the support portion 22 is provided with three bending structures 220, the anchor rod 200 is similar to an “M” type.

[0060] The middle part of the anchoring rod 200 is provided with a bending structure 220, and both ends of the anchoring rod 200 are connected with the stent body 1, compared with the scheme that one end is connected with the stent body 1 and the other end is a free end, the present application has more excellent supporting force and stability, and can prevent the stent body 1 from being circumferentially deviated.

[0061] Specifically, in the embodiment, the middle part of the anchoring rod 200 is provided with a bending structure 220, referring to Figure 6 As shown in 6-2 in the drawings, the middle part of the anchoring rod 200 is bent so that both ends of the anchoring rod 200 are directed to the first end of the stent body 1, and the two ends of the anchoring rod 200, that is, the two connecting parts 21, are respectively connected with the first end of the stent body 1, and the bending structure 220 of the middle part of the anchoring rod 200 extends towards the second end of the stent body 1 when the stent body 1 is in an expanded state. Of course, the connecting part 21 is not limited to the two ends of the anchoring rod 200, but can also be other parts close to the two ends.

[0062] Further, the outer contour of the bending structure 220 is a smooth curve.

[0063] The outer contour of the bending structure 220 is a smooth curve, which can prevent the anchoring member 20 from injuring the myocardial tissue 10 or puncturing the native valve leaflet 9; and in the surgical process, the single anchoring rod 200 will inevitably pull the chordae tendineae during the release process, and the present application has a smooth bending structure 220, which is more easily passed through the chordae tendineae, solving the problem of pulling the chordae tendineae.

[0064] Further, the anchoring member 20 has a first connecting part 211 and a second connecting part 212, referring to Figure 6 and Figure 7 The bending structure 220 includes a first bending segment 221 connected with the first connecting part 211 and a second bending segment 222 connected with the second connecting part 212, and the first bending segment 221 and the second bending segment 222 have a relative torsion angle, so that the anchoring structure 2 forms a spiral closed frame structure.

[0065] The first bending segment 221 and the second bending segment 222 of the bending structure 220 have a relative torsion angle, so that there is a strong interaction force between the first bending segment 221 and the second bending segment 222, when the stent body 1 is released, when subjected to an external force, the stent body 1 has a tendency to be circumferentially displaced, because of the interaction force between the first bending segment 221 and the second bending segment 222, the first bending segment 221 and the second bending segment 222 restrict each other, keep the fixed position of the stent body 1, can guarantee the coaxiality between the stent body 1 and the native annulus, and prevent the stent body 1 from being circumferentially deviated.

[0066] Further, the relative torsion angle of the first bending segment 221 and the second bending segment 222 is 45°-135°.

[0067] As a preferred embodiment, the relative torsion angle of the first bending section 221 and the second bending section 222 is 90°.

[0068] When the anchor 20 is an anchor rod 200, the connecting part 21 and the supporting part 22 are integrated, and the anchor rod 200 is bent in the middle to form the anchor 20. When the relative torsion angle exists between the first bending section 221 and the second bending section 222, because the anchor rod 200 is twisted in the middle, the force point is at the two ends of the anchor rod 200, and the force arm is long, as shown in 7-3 in the drawings, so only a small bending force is needed to form the anchor rod 200. Figure 7

[0069] Further, the anchor structure 2 is connected with the first end of the stent main body 1, the stent main body 1 is in a compressed state, and the anchor structure 2 does not overlap the stent main body 1 in the radial direction of the stent main body 1.

[0070] When the stent main body 1 is in a compressed state and the anchor structure 2 does not overlap the stent main body 1, the radial size of the transcatheter replacement valve stent can be reduced, the delivery is facilitated, and the problem of a large diameter of the delivery system is solved.

[0071] Specifically, in the embodiment, the two ends of the anchor rod 200 are connected with the first end of the stent main body 1 and are integrally formed by a tool heat treatment. Referring to 8-1 in the drawings, the stent main body 1 is in a compressed state, and the anchor rod 200 is in a straightened state and does not overlap the stent main body 1 in the radial direction. Figure 8 Figure 8 Specifically, in the embodiment, the two ends of the anchor rod 200 are connected with the first end of the stent main body 1 and are integrally formed by a tool heat treatment. Referring to 8-1 in the drawings, the stent main body 1 is in a compressed state, and the anchor rod 200 is in a straightened state and does not overlap the stent main body 1 in the radial direction. Figure 8

[0072] The existing replacement valve relies on radial support force for anchoring, in order to provide greater anchoring force, the overall radial size of the stent has to be increased, which will cause conduction block; in addition, the size of the stent after compression is large, which will increase the delivery resistance and cause difficulty in delivery of the device. In the compressed state, the anchor rod 200 can be folded to not overlap the stent main body 1 in the radial direction, so that the transcatheter replacement valve stent has only a single layer in the compressed state, the stent main body 1 and the anchor rod 200 are integrated, which can effectively reduce the delivery size of the transcatheter replacement valve stent, ensure smoother delivery process, and ensure the recyclability of the transcatheter replacement valve stent. It should be noted that “recycling” here refers to the collection of the released part into the sheath tube.

[0073] ​​​Further, the transcatheter replacement valve stent further comprises a skirt structure 3, which is arranged on the stent body 1, and extends around the stent body 1 and towards the outside of the stent body 1. When the stent body 1 is in the expanded state, the skirt structure 3 and the anchoring structure 2 form a first clamping mechanism, which is suitable for clamping the native valve leaflet 9.

[0074] Further, referring to Figure 4 , the skirt structure 3 comprises a first skirt section 31 connected with the stent body 1 and a second skirt section 32 connected with the first skirt section 31. The first skirt section 31 is outwardly curved, and the second skirt section 32 is inwardly curved. As a preferred embodiment, the first skirt section 31 and the stent body 1 are smoothly connected, and the first skirt section 31 and the second skirt section 32 are smoothly connected. It should be noted that the first skirt section 31 is outwardly curved, which means that the first skirt section 31 is curved towards the side away from the center of the stent body 1. Correspondingly, the second skirt section 32 is inwardly curved, which means that the second skirt section 32 is curved towards the side close to the stent body 1. Therefore, the first skirt section 31 and the second skirt section 32 are curved towards opposite directions. The skirt structure 3 can be imagined as a disc-shaped mesh stent, as shown in Figure 1 、 Figure 2 and Figure 4 . The skirt structure 3 provides support for the suturing of the sealing skirt 7, which will be introduced later. Referring to Figure 9 , the second skirt section 32 can be attached to the myocardial tissue 10 or the atrial septum 11 after being curved, which can improve the sealing effect and prevent paravalvular leakage. The first skirt section 31 and the second skirt section 32, or the second skirt section 32 and the stent body 1, have mesh openings therebetween.

[0075] As a preferred embodiment, the support part 22 of the anchoring rod 200 extends into the mesh opening between the first skirt section 31 and the second skirt section 32.

[0076] In addition, the anchoring structure 2 and the skirt structure 3 form a first clamping mechanism, which can clamp the native valve leaflet 9, making the anchoring of the stent body 1 more stable and preventing the stent body 1 from moving along its axial direction. While the anchoring structure 2 provides radial support, the present application can also clamp the native valve leaflet 9 through the cooperation of the anchoring structure 2 and the skirt structure 3, ensuring that the transcatheter replacement valve does not shift and avoiding paravalvular leakage or other complications. In addition, because the skirt structure 3 is located on the atrial side of the native valve leaflet 9, it can clamp the root of the native valve leaflet 9, making the clamping more stable and ensuring that the transcatheter replacement valve is less likely to shift along the radial and axial directions of the stent body 1.

[0077] Specifically, the support part 22 cooperates with the second skirt section 32 of the skirt structure 3 to clamp the native valve leaflet 9 during ventricular contraction, preventing the transcatheter replacement valve from shifting and paravalvular leakage.

[0078] In Figure 2 view, the skirt support structure 32 expands towards the outer side of the stent main body 1, the anchor rod 200 is also arranged on the outer side of the stent main body 1, and the skirt support structure 3 and the support part 22 of the anchor rod 200 form a first clamping mechanism on the outer periphery of the stent main body 1. As previously described, referring to Figure 8 , after the transcatheter replacement valve stent is released, the skirt support structure 3 is located in the left atrium 12, that is, the upper part of the native valve leaflet 9, and the anchor rod 200 is located in the left ventricle 13, that is, the lower part of the native valve leaflet 9, and the skirt support structure 3 and the anchor rod 200 clamp the native valve leaflet 9 therebetween.

[0079] The skirt support structure 3 is a ring-shaped frame structure, and the anchor rod 200 surrounds the stent main body 1, so that a plurality of clamping points are formed between the skirt support structure 3 and the anchor rod 200 around the stent main body 1. Referring to Figure 6 , in this embodiment, the anchor rod 200 is provided with 12 anchor rods, and specifically, the support part 22 of the anchor rod 200 extends to the mesh opening of the skirt support structure 3. The mesh opening of the skirt support structure 3 has at least two skirt support rods capable of clamping the native valve leaflet 9. Compared with the scheme in which the anchor rod 200 and the single skirt support rod of the skirt support structure 3 are correspondingly matched to clamp the native valve leaflet 9, the support part 22 of the anchor rod 200 extends to the mesh opening of the skirt support structure 3, and at least two skirt support rods cooperate with the anchor rod 200 to clamp the native valve leaflet 9, so that the clamping area is large and the clamping is more stable.

[0080] After the stent main body 1 is expanded, at least part of the first bending section 221 is attached to the outer wall of the stent main body 1, forming a second clamping mechanism for clamping the native valve leaflet 9, and the second bending section 222 can provide pressure for clamping due to the relative torsion angle between the first bending section 221 and the second bending section 222, so that the second clamping mechanism clamps more tightly; the 12 anchor members 20 surrounding the stent main body 1 form a cylindrical clamping surface with the stent main body 1, the clamping area is increased, and the native valve leaflet 9 is clamped together with the first clamping mechanism, so that the clamping is more stable, and the sealing effect is also better.

[0081] Further, the adjacent two anchor members 20 are connected with the reinforcing structure 4, which can further improve the strength and stability of the anchor member 20, further prevent the stent main body 1 from being deviated in the circumferential direction, ensure the transverse stability of each anchor structure 2, that is, the horizontal stability, ensure the coaxiality between the stent main body 1 and the native valve annulus, and avoid paravalvular leakage caused by displacement of the stent main body 1. Figure 2

[0082] ​Further, the reinforcing structure 4 comprises reinforcing rods 41, which are in the shape of one or more of V, U, W. In this embodiment, the two ends of the reinforcing rods 41 are connected with two adjacent connecting parts 21 respectively. Referring to Figure 1 In this embodiment, the reinforcing rods 41 are in the shape of V.

[0083] Further, during the releasing process of the whole transcatheter replacement valve stent from the sheath, if the releasing position is not accurately positioned, the whole transcatheter replacement valve stent can be recovered, that is, the whole transcatheter replacement valve stent is retracted into the sheath, and then released again after the position is adjusted. In order to ensure that the whole transcatheter replacement valve stent can be smoothly recovered, in the compressed state, the tips of the V-shaped reinforcing rods 41 are in the same direction as the releasing direction of the transcatheter replacement valve stent. During the releasing process, the first end of the stent body 1 is released earlier than the second end, that is, Figure 2 In this embodiment, the lower end of the stent body 1 is released earlier than the upper end, and in the compressed state, the tips of the V-shaped reinforcing rods 41 are downward, that is, when the transcatheter replacement valve stent needs to be recovered into the sheath due to inaccurate positioning, the tips of the V-shaped reinforcing rods 41 are retracted downward. After unfolding, the anchoring rod 200 is folded outward around its connecting end, and then presents Figure 2 the state shown in the figure, that is, the unfolded state, at this time, the tips of the V-shaped reinforcing rods 41 are upward.

[0084] Further, the second end of the stent body 1 is provided with a delivery connecting structure 5, which comprises a plurality of connecting rods 51 arranged around the stent body 1. One end of the connecting rod 51 is connected with 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 part 52 is arranged at the end, which is suitable for being connected with the delivery system.

[0085] The hanging part 52 protrudes from the connecting rod 51, which is beneficial to provide a fulcrum for connection with the delivery system, and at the same time, can prevent impact force from being generated during the releasing process of the skirt support structure 3, so as to cause displacement of the anchoring part 20 or even cause damage to the heart. In this embodiment, six connecting rods 51 are arranged around the stent body 1 uniformly and at intervals, and the hanging part 52 is a cross rod arranged perpendicularly to the connecting rod 51. Of course, the hanging part 52 can also be a circular ring or other structure protruding from the connecting rod 51.

[0086] Further, a plurality of leaflet suture ears 6 are arranged around the stent body 1. Referring to Figure 4 , the leaflet suture ear 6 is a suture hole arranged on the stent body 1, which provides support for the suture of the artificial valve 8 made of biological or non-biological flexible material.

[0087] Embodiment 2

[0088] A transcatheter replacement valve device comprises the transcatheter replacement valve stent described in Embodiment 1.

[0089] Further, in this embodiment, the transcatheter replacement valve further comprises a sealing skirt 7, the structure of which is shown in Figure 10 Figure 9 The sealing skirt 7 is connected to the skirt support structure 3, and is arranged on the inner side of the stent body 1 in a wraparound manner. The first end of the sealing skirt 7 is connected to the skirt support structure 3, and the second end of the sealing skirt 7 extends towards the first end of the stent body 1.

[0090] Further, the transcatheter replacement valve stent further comprises a leaflet sewing ear 6, and the second end of the sealing skirt 7 partially or completely covers the leaflet sewing ear 6, which can effectively enhance the sealing effect and prevent paravalvular leakage.

[0091] Further, the inner side of the stent body 1 is sewn to the artificial valve 8 through the leaflet sewing ear 6; the artificial valve 8 is provided with two pieces, which is suitable for replacing the mitral valve of the patient; or, the artificial valve 8 is provided with three pieces, which is suitable for replacing the aortic valve of the patient.

[0092] A percutaneous catheter is a catheter inserted through the skin with a needle. All catheters are hollow tubes that allow fluid to enter the body or allow excess body fluids to be drained from the body through the catheter into an appropriate disposal container.

[0093] Embodiment 3

[0094] A transcatheter replacement valve device comprises the transcatheter replacement valve stent described in Embodiment 1. The difference from Embodiment 2 is that, as shown in Figure 11 The sealing skirt 7 can also be provided with a triangular extension segment 71 at the distal end, giving a higher sealing effect. The position of the sealing skirt 7 sewn on the stent body 1 is shown in Figure 12 The triangular extension segment of the sealing skirt 7 is adapted to the triangular window exposed by the diamond grid of the stent body.

[0095] A method for using a transcatheter replacement valve device suitable for mitral valve, comprising the following steps:

[0096] Step S1: puncture the femoral vein of the patient on one side, send the guide wire and puncture sheath into the right atrium, puncture the atrial septum 11, and enter the left ventricle 13 through the mitral valve;

[0097] Step S2: load the transcatheter replacement valve device into the corresponding delivery system, and send the delivery system into the left ventricle 13 along the guide wire track;

[0098] ​Step S3: Adjust the direction of the delivery system through the mark on the delivery system, release the anchor rod 200 first, then release the leaflet suture ear 6 and the skirt support structure 3, make the skirt support structure 3 support at the bottom of the left atrium 12, and finally release the delivery connection structure 5;

[0099] Step S4: Retract the delivery system for the interventional mitral valve to the right atrium 12, send the atrial septum 11 occluder, occlude the atrial septum 11, and complete the operation.

[0100] In the above steps, the positioning, fixing and releasing are completed by one-way retraction of the sheath tube, which effectively reduces the radial size of the delivery system, reduces the compression and damage of the delivery system head to the interventricular septum.

[0101] Operation process: puncture the femoral vein through the atrial septum 11 approach, puncture the interventricular septum, establish a left ventricular 13 to right ventricular guide wire track, send the interventional catheter replacement valve device along the guide wire, release the anchor rod 200, retract the sheath tube, and release the replacement valve. Occlude the atrial septum 11, and the operation is completed.

[0102] According to the above description, the patent application has the following advantages:

[0103] 1. The anchor structure 2 is a closed frame structure arranged around the outer periphery of the stent main body 1, which can provide more stable anchoring force and prevent the stent main body 1 from moving circumferentially; the middle part of the anchor rod 200 is provided with a bending structure 220, and there is a relative torsion angle between the first bending section 221 and the second bending section 222 of the bending structure 220, which has more outstanding supporting force and stability, and can prevent the stent main body 1 from moving circumferentially;

[0104] 2. The anchor structure 2 and the skirt support structure 3 constitute a first clamping mechanism, which can clamp the autologous leaflet 9, so that the anchoring of the stent main body 1 is more stable, and further prevents the stent main body 1 from moving along its axial direction; the first bending section 221 and the stent main body 1 constitute a second clamping mechanism, which further improves the stability of the stent main body 1;

[0105] 3. In the compressed state of the stent main body 1, the anchor structure 2 does not overlap with the stent main body 1, which can reduce the radial size of the transcatheter replacement valve stent in the compressed state, facilitate delivery, and solve the problem of large diameter of the delivery system.

[0106] Obviously, the above embodiments are only examples for clear illustration, and not limitation of the embodiments. For ordinary skilled in the art, other different forms of changes or variations can be made on the basis of the above description. Here, it is not necessary and impossible to enumerate all the embodiments. The obvious changes or variations derived therefrom are still within the protection scope of the present application.

Claims

1. A transcatheter replacement valve stent, characterized by, The stent comprises: a stent body (1) in a radially compressible and expandable cylindrical frame structure, having a compressed state and an expanded state; an anchoring structure (2) in a closed frame structure arranged around the outer periphery of the stent body (1); when the stent body (1) is in the expanded state, the anchoring structure (2) expands towards the outside of the stent body (1) to anchor the stent body (1); the anchoring structure (2) comprises a plurality of anchoring members (20) arranged around the outer periphery of the stent body (1), each anchoring member (20) having at least two connecting portions (21) connected to the stent body (1) through the connecting portions (21), and a supporting portion (22) connecting two adjacent connecting portions (21); when the stent body (1) is in the expanded state, the supporting portion (22) expands towards the outside of the stent body (1) to anchor the stent body (1); the supporting portion (22) has a bending structure (220); the anchoring member (20) has a first connecting portion (211) and a second connecting portion (212), the bending structure (220) comprises a first bending segment (221) connected to the first connecting portion (211) and a second bending segment (222) connected to the second connecting portion (212), and the first bending segment (221) and the second bending segment (222) have a relative torsion angle, so that the anchoring structure (2) forms a spiral closed frame structure.

2. The transcatheter replacement valve stent of claim 1, wherein, The outer contour of the bending structure (220) is a smooth curve.

3. The transcatheter replacement valve stent of claim 1, wherein, The relative torsion angle of the first bending segment (221) and the second bending segment (222) is 45°-135°.

4. The transcatheter replacement valve stent of claim 3, wherein, The relative torsion angle of the first bending segment (221) and the second bending segment (222) is 90°.

5. The transcatheter replacement valve stent of any of claims 1-4, wherein, The anchoring member (20) comprises an anchoring rod (200), both ends of the anchoring rod (200) are the connecting portions (21), and the middle part of the anchoring rod (200) is bent to form the supporting portion (22); the connecting portion (21) of the anchoring rod (200) is connected to the first end of the stent body (1), and when the stent body (1) is in the expanded state, the supporting portion (22) of the anchoring rod (200) extends towards the second end of the stent body (1).

6. The transcatheter replacement valve stent of any one of claims 1-4, wherein, The anchoring structure (2) is connected to the first end of the stent body (1), and when the stent body (1) is in the compressed state, the anchoring structure (2) does not overlap with the stent body (1) in the radial direction of the stent body (1).

7. The transcatheter replacement valve stent of any one of claims 1-4, wherein, Further comprising a skirt support structure (3) arranged on the stent body (1), the skirt support structure (3) surrounds the stent body (1) and expands towards the outside of the stent body (1); when the stent body (1) is in the expanded state, the skirt support structure (3) and the anchoring structure (2) form a clamping mechanism suitable for clamping a native valve leaflet (9).

8. The transcatheter replacement valve stent of claim 7, wherein, The skirt support structure (3) comprises a first skirt support section (31) connected with the support body (1) and a second skirt support section (32) connected with the first skirt support section (31), the first skirt support section (31) is outwardly curved, and the second skirt support section (32) is inwardly curved.

9. The transcatheter replacement valve stent of claim 8, wherein, The support part (22) cooperates with the second skirt support section (32) of the skirt support structure (3) and is suitable for clamping the native leaflet (9).

10. The transcatheter replacement valve stent of any one of claims 1-4, wherein, The reinforcing structure (4) is connected between two adjacent anchor pieces (20).

11. The transcatheter replacement valve stent of claim 10, wherein, The reinforcing structure (4) comprises a reinforcing rod (41), the reinforcing rod (41) is one or a combination of V-shaped, U-shaped, and W-shaped, and two ends of the reinforcing rod (41) are respectively connected with two adjacent anchor pieces (20).

12. The transcatheter replacement valve stent of any one of claims 1-4, wherein, A delivery connection structure (5) is arranged at the second end of the support body (1), the delivery connection structure (5) comprises a plurality of connection rods (51) arranged around the support body (1), one end of the connection rod (51) is connected with the second end of the support body (1), the other end of the connection rod (51) extends away from the second end of the support body (1) along the axial direction of the support body (1), and a hanging part (52) is arranged at the end, the hanging part (52) is suitable for being connected with a delivery system.

13. The transcatheter replacement valve stent of any one of claims 1-4, wherein, A plurality of leaflet suture ears (6) are arranged around the support body (1).

14. A transcatheter replacement valve device, characterized by, The transcatheter replacement valve support comprises a skirt support structure (3), a sealing skirt (7) is connected to the skirt support structure (3), the sealing skirt (7) is arranged on the inner side of the support body (1) in a close-fitting manner, a first end of the sealing skirt (7) is connected with the skirt support structure (3), and a second end of the sealing skirt (7) extends towards the first end of the support body (1).

15. The transcatheter replacement valve device of claim 14, wherein, The transcatheter replacement valve support further comprises a leaflet suture ear (6), and the second end of the sealing skirt (7) partially or completely covers the leaflet suture ear (6).

16. The transcatheter replacement valve device of claim 15, wherein, The transcatheter replacement valve support further comprises a leaflet suture ear (6), and the inner side of the support body (1) is sutured to an artificial valve (8) through the leaflet suture ear (6); the artificial valve (8) is provided with two pieces and is suitable for replacing the mitral valve of a patient; or the artificial valve (8) is provided with three pieces and is suitable for replacing the aortic valve of a patient; or the artificial valve (8) is provided with four pieces and is suitable for the heart valve of a special patient.

17. The transcatheter replacement valve device according to any one of claims 14-16, characterized in that, ​

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