Transcatheter replacement valve device and its stent

Abstract

The application provides a kind of transcatheter replacement valve device and its support, it is related to heart valve technical field.Transcatheter replacement valve support includes support main body and anchoring structure.Support main body is the cylinder type frame structure of radial compression and unfolding, with the state of pressing and unfolding state;When support main body is in the state of pressing, anchoring structure at least partially overlaps with support main body in radial direction, so that transcatheter replacement valve support forms double-layer frame structure when being pressed;When support main body is in the state of unfolding, anchoring structure extends towards the outside of support main body, to anchor support main body.The application can solve the problem of existing technology in the replacement valve support conveying process, the bending difficulty existing in narrow space, the length of the replacement valve support after being pressed can be shortened by the application, the length of bending sheath is short, so that the replacement valve support can avoid large angle bending place in the release process in narrow space, so that bending sheath is more easily bent.

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). The replacement valve needs to be bent at a large angle after transseptal puncture to be perpendicular to the plane where the mitral valve is located for replacement operation. However, the size of the left ventricular space of the human body not only varies in different disease courses, but also varies in different individuals. In the existing replacement valve stent delivery process, there are defects such as difficulty in bending and higher requirements for the mechanical strength and performance of the bending sheath of the delivery system in the narrow space of the left ventricle. SUMMARY

[0003] The technical problem to be solved by the present application is to overcome the defect of difficulty in bending in the narrow space in the replacement valve stent delivery process in the prior art, so as to provide a transcatheter replacement valve device and a stent thereof.

[0004] In order 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 compressed state, the anchoring structure at least partially overlaps the stent body in the radial direction, so that the transcatheter replacement valve stent forms a double-layer frame structure when compressed. 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 anchoring members arranged at intervals around the outer periphery of the stent body. The anchoring member is provided with a fixed end and a free end, and the fixed end is connected with the stent body. When the stent body is in the expanded state, the free end expands outward along the radial direction of the stent body, and is suitable for providing radial anchoring force for the stent body.

[0006] Optionally, the anchoring member has at least two connecting portions, and the anchoring member is connected with the stent body through the connecting portions to form the fixed end. The support portion is connected between the adjacent two connecting portions to form a closed loop structure. 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, and the support portion constitutes the free end.

[0007] Optionally, the support portion has a bending structure.

[0008] Optionally, the outer contour of the bending structure is a smooth curve.

[0009] Optionally, the anchor has a first connecting portion and a second connecting portion, the bending structure includes a first bending segment connected with the first connecting portion and a second bending segment connected with the second connecting portion, and the first bending segment and the second bending segment have a relative torsion angle therebetween, so that the anchor structure forms a spiral closed frame structure.

[0010] Optionally, the relative torsion angle of the first bending segment and the second bending segment is 45°-135°.

[0011] Optionally, the relative torsion angle of the first bending segment and the second bending segment is 90°.

[0012] Optionally, the fixed end is connected with the first end of the stent body, and the free end extends towards the second end of the stent body, so that when the stent body is in the compression state, at least one of the stent body and the anchor structure is entirely overlapped with the other in the radial direction.

[0013] Optionally, the anchor includes an anchor rod, and the two ends of the anchor rod are fixed ends, and the middle part of the anchor rod is bent to form a free end.

[0014] Optionally, it further includes a skirt support structure, the skirt support structure is arranged on the stent body, the skirt support structure surrounds the stent body and extends towards the outside of the stent body, and in the unfolded state of the stent body, the skirt support structure and the anchor structure cooperate to form a clamping mechanism suitable for clamping the native valve leaflet.

[0015] Optionally, the skirt support structure is an annular frame structure, the inner ring of the skirt support structure is connected with the second end of the stent body, and the outer ring of the skirt support structure extends towards the outside of the stent body.

[0016] Optionally, the skirt support structure includes a first skirt support segment connected with the stent body and a second skirt support segment connected with the first skirt support segment, the first skirt support segment is outwardly curved, and the second skirt support segment is inwardly curved.

[0017] Optionally, the first skirt support segment and the stent body, or the first skirt support segment and the second skirt support segment have a mesh opening therebetween, and the free end extends into the mesh opening.

[0018] Optionally, the two adjacent anchors are connected with a reinforcing structure.

[0019] 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 the two ends of the reinforcing rod are respectively connected with the two adjacent anchors.

[0020] Optionally, the second end of the stent body is provided with a delivery connection structure, the delivery connection structure comprises a plurality of connection rods arranged around the stent body, one end of the connection rod is connected with the second end of the stent body, the other end of the connection rod extends away from the second end of the stent body along the axial direction of the stent body, and a hanging part is arranged at the end portion, the hanging part is suitable for being connected with the delivery system.

[0021] Optionally, the stent body is provided with a plurality of leaflet suture ears around the stent body.

[0022] Another aspect of the present application provides a transcatheter replacement valve device, comprising the transcatheter replacement valve stent in any one of the above technical solutions.

[0023] Optionally, the transcatheter replacement valve stent comprises a skirt support structure, and 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 close-fitting manner around the stent body, a first end of the sealing skirt is connected with the skirt support structure, and a second end of the sealing skirt extends towards the first end of the stent body.

[0024] Optionally, the transcatheter replacement valve stent further comprises a leaflet suture ear, and the second end of the sealing skirt partially or completely covers the leaflet suture ear.

[0025] Optionally, the transcatheter replacement valve stent further comprises a leaflet suture ear, and the inner side of the stent body is sutured to an artificial valve through the leaflet suture ear; the artificial valve is provided with two pieces, suitable for replacing the mitral valve of a patient; or, the artificial valve is provided with three pieces, suitable for replacing the aortic valve of a patient; or, the artificial valve is provided with four pieces, suitable for the heart valve of a special patient.

[0026] The present application has the following advantages:

[0027] 1. By using the technical solutions of the present application, since the stent body in the compressed state, the anchoring structure at least partially overlaps the stent body in the radial direction, compared with the existing replacement valve stent, the present application can shorten the length of the replacement valve stent after compression, so that the length of the bending sheath tube occupied in the delivery system is short, so that the replacement valve stent can avoid large angle bending places in the delivery process in a narrow space, so that the bending sheath tube is easier to bend, and the mechanical strength and performance requirements of the bending sheath tube of the delivery system are reduced. In addition, because the anchoring structure is a closed frame structure arranged around the outer periphery of the stent body, compared with the existing multiple independent anchoring rods, when the transcatheter replacement valve stent is released, it can provide more stable anchoring force, the closed frame structure has mutual force, which can provide more stable support force for the stent body, effectively preventing the stent body from moving in the circumferential direction.

[0028] 2. In the crimped state, the stent body and the anchoring structure, at least one of which is completely overlapped in the radial direction with the other, can maximize the shortening of the axial length of the transcatheter replacement valve stent after crimping, and further reduce the difficulty of bending the sheath during delivery.

[0029] 3. The middle part of the anchoring rod is provided with a bending structure, and both ends of the anchoring rod are connected with the stent body. Compared with the single anchoring rod scheme in which one end is connected with the stent body and the other end is a free end, the present application has more excellent supporting force and stability, and can prevent the stent body from being circumferentially deviated.

[0030] 4. There is a relative torsion angle between the first bending section and the second bending section of the bending structure, so that there is a strong interaction force between the first bending section and the second bending section. When the stent body is released, when subjected to external force, the stent body has a tendency to be circumferentially displaced. Because of the interaction force between the first bending section and the second bending section, the first bending section and the second bending section restrict each other, keep the fixed position of the stent body, can guarantee the fit of the stent body and the self-valve leaflet, and prevent the stent body from being circumferentially deviated.

[0031] 5. Compared with the technical scheme of simply relying on the anchoring structure to provide radial supporting force for anchoring, the present application can cooperate with the skirt support structure through the anchoring structure to clamp the self-valve leaflet, which is stable in clamping, can guarantee that the artificial valve is not displaced, and avoid generating perivalvular leakage or causing other complications. Especially, after the transcatheter replacement valve stent is released, the skirt support structure is located on the atrial side of the self-valve leaflet, the anchoring structure is located on the ventricular side, and the free end of the anchoring member extends into the grid opening of the skirt support structure, which can clamp the root of the self-valve leaflet, has better clamping effect, and makes the transcatheter replacement valve more stable after being released.

[0032] 6. The reinforcing structure is connected between adjacent anchoring members, which can further improve the stability of the anchoring structure and further prevent the stent body from being circumferentially deviated. BRIEF DESCRIPTION OF DRAWINGS

[0033] In order to more clearly illustrate the specific embodiments of the present application or the technical solutions in the prior art, the following will briefly introduce the drawings needed to be used in the description of the specific embodiments or the prior art. Obviously, the drawings described below are some embodiments of the present application, and those skilled in the art can also obtain other drawings according to these drawings without creative labor.

[0034] Figure 1 A structure diagram of a transcatheter replacement valve stent provided by an embodiment of the present application is shown;

[0035] Figure 2 A structure diagram of a transcatheter replacement valve stent provided by an embodiment of the present application is shown; Figure 1front view of the device of Fig. 1;

[0036] Figure 3 a front view of the device of Fig. 1 is shown; Figure 1 a top view of the device of Fig. 1 is shown;

[0037] Figure 4 a front view of the device of Fig. 1 is shown; Figure 1 a schematic view of the device of Fig. 1 without the anchoring structure is shown;

[0038] Figure 5 a front view of the device of Fig. 1 is shown; Figure 4 a schematic view of the device of Fig. 1 without the anchoring structure is shown;

[0039] Figure 6 a front view of the device of Fig. 1 is shown; Figure 1 a schematic view of the anchoring structure of the device of Fig. 1 is shown;

[0040] Figure 7 a front view of the device of Fig. 1 is shown; Figure 6 a bottom view of the device of Fig. 1 is shown;

[0041] Figure 8 a schematic view of the device of Fig. 1 is shown;

[0042] Figure 9 a schematic view of one structure of the sealing skirt of the device of Fig. 1 is shown;

[0043] Figure 10 a schematic view of another structure of the sealing skirt of the device of Fig. 1 is shown;

[0044] Figure 11 a schematic view of the structure of the sealing skirt of the device of Fig. 1 and the stent body is shown;

[0045] Figure 12 a schematic view of the device of Fig. 1 is shown;

[0046] BRIEF DESCRIPTION OF DRAWINGS

[0047] 1, stent body; 11, leaflet suture ear; 2, anchoring structure; 21, anchoring member; 211, anchoring rod; 212, connecting part; 2121, first connecting part; 2122, second connecting part; 213, supporting part; 214, bending structure; 2141, first bending section; 2142, second bending section; 3, skirt support structure; 31, first skirt support section; 32, second skirt support section; 33, mesh opening; 4, reinforcing structure; 41, reinforcing rod; 5, delivery connection structure; 51, connecting rod; 52, hanging part; 6, sealing skirt; 61, triangular extension section; 7, artificial valve; 8, native valve leaflet; 81, anterior cusp; 82, posterior cusp; 9, left atrium; 10, left ventricle; 20, myocardial tissue; 30, atrial septum; 40, bending sheath. DETAILED DESCRIPTION

[0048] The technical solutions of the present application will be described clearly and completely in combination with the drawings. Obviously, the described embodiments are part of the embodiments of the present application, but not all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor fall within the scope of protection of the present application.

[0049] 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.

[0050] In the description of the present application, it should be noted that unless otherwise explicitly specified and limited, the terms "mounting", "connection", "connection" should be understood broadly, for example, it can be fixedly connected, or it can be detachably connected, or integrally connected; it can be mechanically connected, or it can be electrically connected; it can be directly connected, or it can be indirectly connected through an intermediate medium; it can be the communication inside 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.

[0051] In addition, the technical features involved in the different embodiments of the present application described below can be combined with each other as long as they do not conflict with each other.

[0052] In order to facilitate the introduction of the technical solutions of the present application, the following will be described in combination with the drawings and specific embodiments, but the embodiments should not be regarded as a limitation on the present application.

[0053] Embodiment 1

[0054] 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, with reference to Figures 1-7, including a stent body 1 and an anchoring structure 2. Wherein the stent body 1 is a radially compressible and expandable cylindrical frame structure, having 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 compressed state, the anchoring structure 2 at least partially overlaps the stent body 1 in the radial direction, so that the transcatheter replacement valve stent forms a double-layer frame structure when compressed; 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.

[0055] By using the technical scheme of the present application, since the stent body 1 in the compressed state, the anchoring structure 2 at least partially overlaps the stent body 1 in the radial direction, compared with the existing replacement valve stent, the present application can greatly shorten the length of the replacement valve stent after compression, so that the replacement valve stent occupies a shorter length of the bending sheath 40 in the delivery system, and the replacement valve stent can avoid large-angle bending places in the delivery process in a narrow space, so that the bending sheath 40 is easier to bend and the mechanical strength and performance requirements of the bending sheath 40 of the delivery system are reduced. In addition, 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 211, after the transcatheter replacement valve stent is released, it can provide more stable anchoring force, the closed frame structure has mutual force, high overall strength, and can provide more stable support force for the stent body 1, effectively preventing the stent body 1 from moving circumferentially.

[0056] The transcatheter replacement valve stent provided by the present application 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 scheme of the present application.

[0057] Reference Figure 12, the delivery system includes a bending sheath 40, the replacement valve stent carrying the artificial valve 7 is loaded into the bending sheath 40 after being compressed and gripped, the bending sheath 40 enters the left atrium 9 after passing through the interatrial septum 30 from the right atrium, at this time, a bending of about 90° is needed, the head end of the bending sheath 40 is in a transverse state when passing through the interatrial septum 30, and continues to advance to enter the left ventricle 10, which needs to be bent from transverse to vertical, that is, the head end of the bending sheath 40 is bent at about 90° with the main body part, which is also the area with the largest bending angle in the entire replacement surgery process. However, in the prior art, the axial length of the replacement valve stent after being compressed and gripped is greater than the axial length in the expanded state, the left atrium 9 is narrow in space, the bending is difficult, and the replacement valve stent loaded in the bending sheath 40 makes the bending more difficult and requires higher mechanical strength and performance of the bending sheath 40. The replacement valve stent is provided with a double-layer structure, which greatly shortens the length of the replacement valve stent after being compressed and gripped, so that the replacement valve stent is located at the head end of the bending sheath 40, can avoid the maximum bending part of the bending sheath 40, and only needs to bend the bending sheath 40, with reference to Figure 12 , the bending part is free of the replacement valve stent, which greatly reduces the bending difficulty, improves the efficiency and success rate of the replacement surgery, and reduces the requirement for the mechanical strength and performance of the bending sheath 40, and reduces the cost of the bending sheath 40.

[0058] Further, with reference to Figures 1-8 , the stent body 1 has a first end and a second end arranged oppositely, so that Figure 2 , the first end of the stent body 1 is the lower end, which is also the outflow end; and the second end of the stent body 1 is the upper end, which is also the inflow end. After the stent body 1 is released, with reference to Figure 8 , the first end of the stent body 1 is located in the left ventricle 10, and the second end of the stent body 1 is located in the left atrium 9.

[0059] Further, with reference to Figure 6 and Figure 7, 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 member 21 is provided with a fixed end and a free end, the fixed end is connected with the stent body 1, and the free end of the anchoring structure 2 expands outward in the radial direction of the stent body 1 in the expanded state of the stent body 1, and is suitable for providing radial support force for the stent body 1, so as to anchor the stent body 1. As a preferred embodiment, the fixed end is connected with the first end of the stent body 1, and the free end extends towards the second end of the stent body 1, so that when the stent body 1 is in the crimped state, at least one of the stent body 1 and the anchoring structure 2 is completely overlapped in the radial direction with the other. In this way, the length of the anchoring structure 2 and the stent body 1 overlapped in the radial direction can be maximized, and the length of the replacement valve stent after crimping can be shortened to the maximum. In the embodiment, since the second end of the stent body 1 is also connected with the skirt support structure 3, the total axial length of the skirt support structure 3 and the stent body 1 in the crimped state is greater than the axial length of the anchoring member 21, that is, the stent body 1 is completely overlapped with the anchoring member 21 in the radial direction in the crimped state.

[0060] The plurality of anchoring members 21 arranged at intervals around the outer periphery of the stent body 1 can provide radial support force around the stent body 1, and ensure that the stent body 1 is anchored stably. As a preferred embodiment, the plurality of anchoring members 21 are arranged at intervals uniformly around the outer periphery of the stent body 1, so that the circumferential direction of the stent body 1 is uniformly supported, and the radial displacement of the stent body 1 is prevented.

[0061] Further, referring to Figure 6 and Figure 7 , Figure 6 6-2 in and 7-2 in Figure 7 are shown as a structure schematic diagram of a single anchoring rod 200. The anchoring member 21 is arranged around the outer periphery of the stent body 1, and the anchoring member 21 has at least two connecting portions 212, the anchoring member 21 is connected with the stent body 1 through the connecting portion 212 to form the above-mentioned fixed end, and the adjacent two connecting portions 212 are connected through the support portion 213 to form a closed loop structure; in the expanded state of the stent body 1, the support portion 213 expands towards the outside of the stent body 1, and the stent body 1 is anchored by providing radial support force, and the support portion 213 constitutes the above-mentioned free end. When the stent body 1 is in the expanded state, the anchoring member 21 is released from the outer periphery of the stent body 1 and expands outward, and the anchoring member 21 can provide radial anchoring force for the stent body 1, so that the stent body 1 is fixed. As a preferred embodiment, the plurality of anchoring members 21 are connected end to end on the stent body 1, or the plurality of anchoring members 21 are arranged at intervals uniformly on the stent body 1, when the adjacent anchoring members 21 are arranged at intervals, the anchoring members 21 are all connected with the stent body 1 to form a closed loop frame structure, or the closed loop frame structure can also be connected through the reinforcing structure 4, refer to 6 and Figure 7The reinforcing structure 4 will be introduced later. The plurality of anchors 21 can provide more balanced anchoring force to the outer periphery of the stent main body 1, so that the anterior and posterior cusps 81 and 82 of the mitral valve can be uniformly clamped to ensure stable clamping.

[0062] Further, in the embodiment, the anchor 21 comprises an anchor rod 211, as shown in Figure 1 , Figure 6 and Figure 7 The two ends of the anchor rod 211 are connected to the first end of the stent main body 1, and the support portion 213 of the anchor rod 211 extends towards the second end of the stent main body 1 when the stent main body 1 is in the expanded state.

[0063] Further, the support portion 213 has a bending structure 214. The number of bending structures 214 can be one or more. For example, when the support portion 213 has one bending structure 214, the anchor rod 211 is similar to the letter "n" type; when the support portion 213 has three bending structures 214, the anchor rod 211 is similar to the letter "m" type.

[0064] The middle portion of the anchor rod 211 is provided with a bending structure 214, and the two ends of the anchor rod 211 are connected to the stent main body 1. Compared with the single anchor rod scheme in which one end is connected to the stent main body 1 and the other end is a free end, the present application has better support force and stability, and can prevent the stent main body 1 from being circumferentially offset.

[0065] Specifically, in the embodiment, the middle portion of the anchor rod 211 is provided with a bending structure 214, as shown in Figure 6 The two ends of the anchor rod 211 are connected to the first end of the stent main body 1, and the support portion 213 of the anchor rod 211 extends towards the second end of the stent main body 1 when the stent main body 1 is in the expanded state. Of course, the connection portion 212 is not limited to the two ends of the anchor rod 211, but can also be other parts near the two ends.

[0066] Further, the outer contour of the bending structure 214 is a smooth curve.

[0067] The outer contour of the bending structure 214 is a smooth curve, which can prevent the anchor 21 from injuring the myocardial tissue 20 or piercing the autologous valve leaflet 8; and during the operation, the single anchor rod 211 will inevitably pull the chordae tendineae during release, and the present application has a smooth bending structure 214, which is more easily passed through the chordae tendineae, solving the problem of pulling the chordae tendineae.

[0068] Further, the anchor 21 has a first connecting portion 2121 and a second connecting portion 2122, referring to Figure 6 and Figure 7 The bending structure 214 includes a first bending segment 2141 connected with the first connecting portion 2121, and a second bending segment 2142 connected with the second connecting portion 2122, and the first bending segment 2141 and the second bending segment 2142 have a relative torsion angle, so that the anchor structure 2 forms a spiral closed frame structure.

[0069] The first bending segment 2141 and the second bending segment 2142 of the bending structure 214 have a relative torsion angle, so that there is a strong interaction force between the first bending segment 2141 and the second bending segment 2142. When the stent main body 1 is released, when subjected to external force, the stent main body 1 has a tendency to shift circumferentially. Because of the interaction force between the first bending segment 2141 and the second bending segment 2142, the first bending segment 2141 and the second bending segment 2142 restrict each other, maintain the fixed position of the stent main body 1, and can ensure the clamping stability between the stent main body 1 and the native annulus, and prevent the stent main body 1 from circumferentially shifting.

[0070] Further, the relative torsion angle of the first bending segment 2141 and the second bending segment 2142 is 45°-135°.

[0071] As a specific embodiment, the relative torsion angle of the first bending segment 2141 and the second bending segment 2142 is 45°.

[0072] Of course, as another specific embodiment, the relative torsion angle of the first bending segment 2141 and the second bending segment 2142 is 135°

[0073] As a preferred embodiment, in this embodiment, the relative torsion angle of the first bending segment 2141 and the second bending segment 2142 is 90°.

[0074] When the anchor 21 is an anchor rod 211, the connecting portion 212 and the supporting portion 213 are integrated, and the anchor rod 211 is bent from the middle to form the anchor 21. When the first bending segment 2141 and the second bending segment 2142 have a relative torsion angle, because the middle part of the anchor rod 211 is twisted, the force point is at the two ends of the anchor rod 211, and the force arm is long, as shown in Figure 7 7-3, so only a small bending force is needed to form.

[0075] Further, the transcatheter replacement valve stent further comprises a skirt structure 3, which is arranged on the stent body 1, the skirt structure 3 surrounds the stent body 1 and extends towards the outside of the stent body 1, and in the unfolded state of the stent body 1, the skirt structure 3 and the anchoring structure 2 cooperatively form a first clamping mechanism, which is suitable for clamping the native valve leaflet 8.

[0076] Further, the skirt structure 3 is a ring-shaped frame structure, the inner ring of the skirt structure 3 is connected with the second end of the stent body 1, and the outer ring of the skirt structure 3 extends towards the outside of the stent body 1.

[0077] The anchoring structure 2 of the present application can provide radial support and can also clamp the native valve leaflet 8 through the cooperation of the anchoring structure 2 and the skirt structure 3 to form a first clamping mechanism, so as to prevent the transcatheter replacement valve stent from moving, to avoid paravalvular leakage or other complications. In addition, because the skirt structure 3 is located on the atrial side of the native valve leaflet 8, it can clamp the root of the native valve leaflet 8, which is more stable and can prevent the transcatheter replacement valve from moving along the radial and axial directions of the stent body 1.

[0078] Specifically, the support part 213 cooperates with the second skirt section 32 of the skirt structure 3 to clamp the native valve leaflet 8 during ventricular contraction, thereby preventing the transcatheter replacement valve from moving and preventing paravalvular leakage.

[0079] In the view of Figure 2 , the skirt structure 32 extends towards the outside of the stent body 1, the anchoring rod 211 is also arranged on the outside of the stent body 1, and the skirt structure 3 and the support part 213 of the anchoring rod 211 form a first clamping mechanism on the outer periphery of the stent body 1, as described above, referring to Figure 8 , after the transcatheter replacement valve stent is released, the skirt structure 3 is located in the left atrium 9, that is, on the upper part of the native valve leaflet 8, and the anchoring rod 211 is located in the left ventricle 10, that is, on the lower part of the native valve leaflet 8, and the skirt structure 3 and the anchoring rod 211 clamp the native valve leaflet 8 therebetween.

[0080] Further, referring to Figure 4, the skirt support structure 3 comprises a first skirt support section 31 connected with the stent main 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. As a preferred embodiment, the first skirt support section 31 and the stent main body 1 are smoothly connected, and the first skirt support section 31 and the second skirt support section 32 are smoothly connected. It should be noted that the outward curvature of the first skirt support section 31 means that the first skirt support section 31 is curved towards the side away from the center of the stent main body 1, and correspondingly, the inward curvature of the second skirt support section 32 means that the second skirt support section 32 is curved towards the side close to the stent main body 1. Therefore, the first skirt support section 31 and the second skirt support section 32 are curved towards opposite directions. The skirt support structure 3 can be seen as a disc-shaped mesh stent, as shown in Figure 1 、 Figure 2 and Figure 4 . The skirt support structure 3 provides support for the suturing of the flexible sealing skirt 6. The sealing skirt 6 will be introduced later. Referring to Figure 9 , the second skirt support section 32 can be attached to the myocardial tissue 20 or the atrial septum 30 after being curved, which can improve the sealing effect and prevent paravalvular leakage. The first skirt support section 31 and the second skirt support section 32, or the second skirt support section 32 and the stent main body 1, have a mesh opening 33 therebetween.

[0081] As a preferred embodiment, the support part 213 of the anchor rod 211 extends into the mesh opening 33.

[0082] The skirt support structure 3 is a ring-shaped frame structure, and the anchor rod 211 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 211 around the stent main body 1. Referring to Figure 6 , in this embodiment, 12 anchor rods 211 are provided, and specifically, the support part 213 of the anchor rod 211 extends to the mesh opening 33 of the skirt support structure 3. The mesh opening 33 of the skirt support structure 3 has at least two skirt support rods capable of clamping the native valve leaflet 8. Compared with the scheme in which the anchor rod 211 and the single skirt support rod of the skirt support structure 3 correspondingly cooperate to clamp the native valve leaflet 8, the support part 213 of the anchor rod 211 extends to the mesh opening 33 of the skirt support structure 3, and at least two skirt support rods cooperate with the anchor rod 211 to clamp the native valve leaflet 8, so that the clamping area is large and the clamping is more stable.

[0083] After the stent body 1 is unfolded, the first bending section 2141 is at least partially attached to the outer wall of the stent body 1, forming a second clamping mechanism for clamping the native leaflet 8, and the second bending section 2142 can provide pressure for clamping due to the relative torsion angle between the first bending section 2141 and the second bending section 2142, so that the second clamping mechanism clamps more tightly; the 12 anchor structures 21 around the stent body 1 form a cylindrical clamping surface with the stent body 1, the clamping area is increased, and the first clamping mechanism and the second clamping mechanism jointly clamp the native leaflet 8, which is more stable and has better sealing effect.

[0084] Further, the adjacent two anchor structures 21 are connected with the reinforcing structure 4, which can further improve the strength and stability of the anchor structure 21, further prevent the stent body 1 from being offset in the circumferential direction, ensure the lateral stability of the anchor structure 2, and Figure 2 from the horizontal stability, ensure the clamping stability between the stent body 1 and the native annulus, and avoid the displacement of the stent body 1 and the perivalvular leakage.

[0085] Further, the reinforcing structure 4 includes a reinforcing rod 41, and the reinforcing rod 41 is in one or a combination of V-shaped, U-shaped, and W-shaped. In the embodiment, the two ends of the reinforcing rod 41 are respectively connected with the adjacent two connecting parts 212. Referring to Figure 1 , in the embodiment, the reinforcing rod 41 is V-shaped. The reinforcing rod 41 is attached to the stent body 1 and connected by suturing, and the suturing line is omitted in the drawings. The V-shaped, U-shaped, and W-shaped refer to the shape of the reinforcing rod 41, and since the reinforcing rod 41 is connected to the stent body 1 by suturing, the setting direction of the reinforcing rod 41 is not limited. Taking the V-shaped reinforcing rod 41 as an example, in the embodiment, the tip of the V-shaped reinforcing rod 41 faces the second end of the stent body 1, and Figure 2 from the horizontal direction, the tip of the V-shaped reinforcing rod 41 faces downward. Of course, in some other embodiments, the tip of the V-shaped reinforcing rod 41 can be arranged upward. Moreover, the connecting position of the reinforcing rod 41 is not limited to the first end of the stent body 1, and can be located at the middle part of the stent body 1. At this time, in order not to affect the unfolding of the anchor rod 211, the reinforcing rod 41 can not be connected to the stent body 1, and the reinforcing rod 41 connects the plurality of anchor structures 21 into a closed frame, further improving the circumferential stability of the anchor structure 2.

[0086] Further, the second end of the stent body 1 is provided with a delivery connecting structure 5, referring to Figure 4 , the delivery connecting structure 5 includes 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, 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, and the hanging part 52 is suitable for being connected with a delivery system.

[0087] The hanging part 52 protrudes from the connecting rod 51, which is conducive to providing a fulcrum for connection with the delivery system, and can prevent impact force from being generated during the release process of the skirt support structure 3, causing the anchor 21 to be displaced or even causing heart injury. In this embodiment, six connecting rods 51 are evenly spaced around the stent main body 1, and the hanging part 52 is a crossbar perpendicular 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.

[0088] Further, the stent main body 1 is provided with a plurality of leaflet suture ears 11 around the stent main body 1. Referring to Figure 4 , the leaflet suture ear 11 is a suture hole provided on the stent main body 1, which provides support for the suture of the artificial valve 7 made of biological or non-biological flexible material.

[0089] Embodiment 2

[0090] A transcatheter replacement valve device comprises the transcatheter replacement valve stent described in Embodiment 1.

[0091] Further, in this embodiment, the transcatheter replacement valve further comprises a sealing skirt 6, and the structure of the sealing skirt 6 is as shown in Figure 9 . In this embodiment, the sealing skirt 6 is a PET mesh cloth. Referring to Figure 8 , the sealing skirt 6 is connected to the skirt support structure 3, and the sealing skirt 6 is arranged on the inner side of the stent main body 1 in a close-fitting manner around the stent main body 1. The first end of the sealing skirt 6 is connected to the skirt support structure 3, and the second end of the sealing skirt 6 extends towards the first end of the stent main body 1.

[0092] Further, 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, which can effectively enhance the sealing effect and prevent paravalvular leakage.

[0093] Further, the inner side of the stent main body 1 is sutured to the artificial valve 7 through the leaflet suture ear 11; the artificial valve 7 is provided with two pieces, which is suitable for replacing the mitral valve of the patient; or, the artificial valve 7 is provided with three pieces, which is suitable for replacing the aortic valve of the patient.

[0094] 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 through the catheter outside the body into a suitable disposal container.

[0095] Embodiment 3

[0096] A transcatheter replacement valve device comprises the transcatheter replacement valve stent described in Embodiment 1.

[0097] The difference from Embodiment 2 is that, as Figure 10As shown, the sealing skirt 6 can also be provided with a distal triangular extension 61 to give a higher sealing effect. Figure 11 As shown, the stent body 1 is a rhombic grid structure, and the triangular extension 61 of the sealing skirt 6 is matched with the triangular window exposed by the rhombic grid of the stent body 1.

[0098] The application method of the transcatheter replacement valve device suitable for a mitral valve comprises the following steps:

[0099] Step S1: puncture the femoral vein of a patient, send a guide wire and a puncture sheath into the right atrium, puncture the interatrial septum 30, and pass through the mitral valve to enter the left ventricle 10;

[0100] Step S2: load the transcatheter replacement valve device into a corresponding delivery system, and send the delivery system into the left ventricle 10 along the guide wire track;

[0101] Step S3: adjust the direction of the delivery system through the mark on the delivery system, release the anchor rod 211 first, then release the leaflet suture ear 11 and the skirt support structure 3, make the skirt support structure 3 support at the bottom of the left atrium 9, and finally release the delivery connection structure 5;

[0102] Step S4: withdraw the delivery system for interventional mitral valve to the right atrium 12, send the interatrial septum 30 occluder into the interatrial septum 30, occlude the interatrial septum 30, and complete the operation.

[0103] In the above steps, the positioning, fixing and releasing steps are completed by one-way withdrawal of the sheath, which effectively reduces the radial size of the delivery system and reduces the compression and damage of the head end of the delivery system to the interventricular septum.

[0104] Operation process: puncture the femoral vein and enter the interatrial septum 30, puncture the interventricular septum, establish a left ventricle 10 to right ventricle guide wire track, send the interventional transcatheter replacement valve device along the guide wire, release the anchor rod 211, withdraw the sheath, release the replacement valve, occlude the interatrial septum 30, and end the operation.

[0105] According to the above description, the patent application has the following advantages:

[0106] 1. The application can shorten the length of the replacement valve stent after compression, occupy a short length of the bending sheath 40, and make the replacement valve stent avoid a large angle bending place in the release process, so that the bending sheath 40 is easier to bend.

[0107] 2、The anchoring 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 circumferential displacement; the middle part of the anchoring rod 211 is provided with a bending structure 214, and there is a relative torsion angle between the first bending section 2141 and the second bending section 2142 of the bending structure 214, which has more outstanding supporting force and stability and can prevent the stent main body 1 from circumferential displacement;

[0108] 3、The anchoring structure 2 and the skirt support structure 3 constitute a first clamping mechanism, which can clamp the native leaflet 8, so that the anchoring of the stent main body 1 is more stable, and further prevent the stent main body 1 from axial displacement; the first bending section 2141 and the stent main body 1 constitute a second clamping mechanism, which further improves the stability of the stent main body 1;

[0109] 4、The reinforcing structure 4 can further improve the strength and stability of the anchoring rod 211, effectively prevent the displacement of the anchoring rod 211, avoid the influence of the displacement of the replacement valve by the catheter on the clamping stability with the native annulus, and avoid the occurrence of paravalvular leakage.

[0110] Obviously, the above embodiments are only examples for clearly illustrating, and not limit the embodiments. For those skilled in the art, on the basis of the above description, other different forms of changes or variations can also be made. 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 application relates to a transcatheter replacement valve stent, which comprises the following parts: a stent body (1) which is a radially compressible and expandable cylindrical frame structure and has a compressed state and an expanded state; an anchoring structure (2) which is a closed frame structure arranged around the outer periphery of the stent body (1); when the stent body (1) is in the compressed state, the anchoring structure (2) at least partially overlaps the stent body (1) in the radial direction, so that the transcatheter replacement valve stent forms a double-layer frame structure when compressed; 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 (21) which are arranged at intervals around the outer periphery of the stent body (1), the anchoring members (21) are provided with fixed ends and free ends, the fixed ends are connected with the stent body (1); when the stent body (1) is in the expanded state, the free ends expand outward along the radial direction of the stent body (1) and are suitable for providing radial anchoring force for the stent body (1); the anchoring member (21) has a first connecting part (2121) and a second connecting part (2122), the anchoring member (21) is connected with the stent body (1) through the connecting parts to form the fixed end, two adjacent connecting parts are connected through a supporting part (213) to form a closed loop structure; when the stent body (1) is in the expanded state, the supporting part (213) expands towards the outside of the stent body (1) to anchor the stent body (1), and the supporting part (213) forms the free end; the supporting part (213) has a bending structure (214); the bending structure (214) comprises a first bending section (2141) connected with the first connecting part (2121) and a second bending section (2142) connected with the second connecting part (2122), the first bending section (2141) and the second bending section (2142) 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 (214) is a smooth curve.

3. The transcatheter replacement valve stent of claim 1, wherein, The relative torsion angle of the first bending section (2141) and the second bending section (2142) is 45-135 degrees.

4. The transcatheter replacement valve stent of claim 3, wherein, The relative torsion angle of the first bending section (2141) and the second bending section (2142) is 90 degrees.

5. The transcatheter replacement valve stent of any of claims 1-4, wherein, The fixed end is connected with the first end of the stent body (1), and the free end extends towards the second end of the stent body (1), so that when the stent body (1) is in the compressed state, at least one of the stent body (1) and the anchoring structure (2) is completely overlapped with the other in the radial direction.

6. The transcatheter replacement valve stent of any one of claims 1-4, wherein, Further comprising a skirt support structure (3) provided on the stent main body (1), the skirt support structure (3) surrounds the stent main body (1) and extends towards the outside of the stent main body (1), the skirt support structure (3) and the anchoring structure (2) cooperate to form a clamping mechanism when the stent main body (1) is in an expanded state, and the clamping mechanism is suitable for clamping a native valve leaflet (8).

7. The transcatheter replacement valve stent of claim 6, wherein, The skirt support structure (3) is a ring-shaped frame structure, the inner ring of the skirt support structure (3) is connected with the second end of the stent main body (1), and the outer ring of the skirt support structure (3) extends towards the outside of the stent main body (1).

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 stent main 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 first skirt support section (31) and the stent main body (1) are connected, or the first skirt support section (31) and the second skirt support section (32) are connected, and a grid opening (33) is formed therebetween, and the free end extends into the grid opening (33).

10. The transcatheter replacement valve stent of any one of claims 1-4, wherein, Two adjacent anchoring members (21) are connected by a reinforcing structure (4), and two ends of the reinforcing structure (4) are connected with two adjacent connecting portions, respectively.

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 connected with two adjacent anchoring members (21), respectively.

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

13. The transcatheter replacement valve stent of any one of claims 1-4, wherein, The stent main body (1) is provided with a plurality of valve leaflet suture ears (11) around the stent main body (1).

14. A transcatheter replacement valve device, characterized by, The transcatheter replacement valve stent comprises the skirt support structure (3) of any one of claims 1-13.

15. The transcatheter replacement valve device of claim 14, wherein, The transcatheter replacement valve stent comprises a skirt support structure (3), a sealing skirt (6) is connected to the skirt support structure (3), the sealing skirt (6) is arranged on the inner side of the stent main body (1) in a close-fitting manner around the stent main body (1), a first end of the sealing skirt (6) is connected with the skirt support structure (3), and a second end of the sealing skirt (6) extends towards the first end of the stent main body (1).

16. The transcatheter replacement valve device of claim 15, wherein, The transcatheter replacement valve stent further comprises a valve leaflet suture ear (11), and the second end of the sealing skirt (6) partially or completely covers the valve leaflet suture ear (11).

17. The transcatheter replacement valve device according to any one of claims 14-16, characterized in that, The transcatheter replacement valve support further comprises a leaflet sewing lug (11), and an inner side of the support body (1) is connected with an artificial valve (7) through the leaflet sewing lug (11); the artificial valve (7) is provided with two pieces, and is suitable for replacing a mitral valve of a patient; or the artificial valve (7) is provided with three pieces, and is suitable for replacing an aortic valve of a patient; or the artificial valve (7) is provided with four pieces, and is suitable for a heart valve of a special patient.

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