Interventional valve prosthesis

Abstract

The invention relates to an interventional valve prosthesis. The valve leaflet hook comprises a body support and a valve leaflet hook, the valve leaflet hook comprises a first curved bar and a plurality of second curved bars, the two ends of the first curved bar are connected with the body support, the middle section of the first curved bar extends in the axial direction of the body support to form a clamping end, and a first space is defined by the first curved bar; the two ends of the second curved bar are connected with the body support and / or the first curved bar respectively, and the middle section of the second curved bar extends in the axial direction or the circumferential direction of the body support to form a clamping end located in the first space. The valve leaflet hook is arranged to comprise the first curved bar and the second curved bar, and the clamping end of the second curved bar is distributed in the first space defined by the first curved bar, namely, the clamping end of the second curved bar divides and blocks the first space defined by the first curved bar, and therefore the valve leaflet hook can be used for clamping the valve leaflet. The natural leaflets cannot escape from the hollow part of the first curved bar under the action of the second curved bar, so that the situation that the escaping natural leaflets float to block other blood flow channels is avoided, and application of the interventional valve prosthesis is facilitated.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to an interventional valve prosthesis. BACKGROUND

[0002] This part provides only background information related to the present disclosure, which does not necessarily have to be prior art.

[0003] The human heart includes four heart valves that define the path of blood flow through the heart: the mitral, tricuspid, aortic, and pulmonary valves. Of these, the mitral and tricuspid valves are atrioventricular valves, located between the atria and ventricles, while the aortic and pulmonary valves are semilunar valves, located in the arteries leaving the heart. Ideally, the natural leaflets of a heart valve separate from each other when the valve is in an open position, and coapt when the valve is in a closed position, such that the valve functions as a one-way valve to direct blood flow in one direction. However, for various reasons, damage or disease can occur to a heart valve, such that the valve function can be gradually lost, for example, regurgitation due to valve insufficiency, stenosis due to valve narrowing, or both, thereby increasing the burden on the heart and leading to heart failure. Valve replacement surgery, which uses a catheter-based delivery system to percutaneously deliver a prosthetic valve to replace a native valve, is one of the most effective ways to treat valve disease recognized by the academic community in recent years.

[0004] Among them, how to fix the artificial valve on the native valve is one of the difficulties in valve replacement surgery. At present, many artificial valves connect a folded curved rod outside the valve stent, and the curved rod cooperates with the valve stent to form a "U" shape to hold the natural leaflet, so as to fix the artificial valve on the native valve. However, in the design of such artificial valves, in order to increase the contact area between the curved rod and the natural leaflet and hold as many natural leaflets as possible, the circumferential width of the curved rod is usually set to be large, so that the natural leaflet will escape from the hollow part of the curved rod under the impact of blood flow and float outside the artificial valve, eventually causing the blood flow channel to be blocked by the natural leaflet, which is not conducive to the application of the artificial valve. SUMMARY

[0005] Therefore, it is necessary to provide an interventional valve prosthesis that can prevent the natural leaflet from blocking the blood flow channel.

[0006] The present application provides an interventional valve prosthesis, which comprises a main body stent and a leaflet hook, wherein the main body stent is provided with a lumen, and the leaflet hook comprises:

[0007] A first curved rod, both ends of which are connected with the body support, and a middle section of which extends along an axial direction of the body support to form a clamping end, the first curved rod being rotatable relative to the body support in the axial direction to approach or move away from the body support, and the first curved rod surrounding a first space; and a plurality of second curved rods, both ends of each of which are connected with the body support and / or the first curved rod, and a middle section of each of which extends along an axial direction or a circumferential direction of the body support to form a clamping end located in the first space, the second curved rods being rotatable relative to the body support in the axial direction to approach or move away from the body support.

[0008] In one embodiment, the first curved rod includes an abutting section and two connecting sections, the two connecting sections being symmetrically arranged about the abutting section, and each of the two connecting sections being connected with the body support at one end and connected with the abutting section at the other end after being radially bent.

[0009] In one embodiment, the connecting points of the two connecting sections on the body support are circumferentially spaced apart, and the other ends of the two connecting sections are connected with the abutting section after moving away from each other and then moving towards each other.

[0010] In one embodiment, the circumferential width of the abutting section gradually increases or first increases and then decreases from one end connected with the connecting sections to the other end away from the connecting sections.

[0011] In one embodiment, both ends of each of the second curved rods are connected with the other ends of the two connecting sections not connected with the body support, and the clamping end of each of the second curved rods is deflected towards the side of the body support to be located between the body support and the clamping end of the first curved rod.

[0012] In one embodiment, the circumferential width of each of the second curved rods gradually decreases from one end connected with the body support or the first curved rod to the other end away from the body support or the first curved rod.

[0013] In one embodiment, the interventional valve prosthesis further includes a skirt support connected with the body support and extending in a radial direction, the connecting ends of the skirt support and the leaflet hook of the valve leaflet are located at opposite axial ends of the body support, and the first curved rod extends along the axial direction of the body support to abut against the skirt support and then extends along the skirt support in the radial direction.

[0014] In one embodiment, the body support includes a nested inner layer support and outer layer support, the lumen is arranged on the inner layer support, and a buffer gap is arranged between the outer wall of the inner layer support and the inner wall of the outer layer support.

[0015] In one embodiment, the buffer gap is a non-uniform annular shape.

[0016] In one embodiment, the leaflet hook is connected to the inner layer stent, and the outer layer stent is located between the leaflet hook and the inner layer stent.

[0017] In one embodiment, the outer layer stent is further provided with a notch, and the inner layer stent does not overlap the notch in the axial direction.

[0018] In one embodiment, the interventional valve prosthesis further comprises a leaflet structure arranged on the main body stent, and the leaflet structure can be opened or closed to make the lumen in an open and closed state.

[0019] The embodiment of the present application provides an interventional valve prosthesis, by arranging the leaflet hook to comprise a first curved rod and a second curved rod, the first curved rod and the second curved rod can rotate relative to the main body stent in the axial direction, and the clamping end of the second curved rod is distributed in the first space defined by the first curved rod, that is, the clamping end of the second curved rod divides and blocks the first space defined by the first curved rod, therefore, when the interventional valve prosthesis is fixed on the native valve, the natural leaflet can be first captured between the first curved rod and the main body stent by rotating the first curved rod, and then the second curved rod is rotated to make the second curved rod clamp and abut the natural leaflet located between the first curved rod and the main body stent again, under the blocking effect of the clamping end of the second curved rod on the first curved rod, the natural leaflet is stably clamped between the main body stent and the leaflet hook, and will not escape from the hollow part of the first curved rod, so that the situation that the escaped natural leaflet blocks other blood flow channels due to floating can be avoided, and the application of the interventional valve prosthesis is facilitated. BRIEF DESCRIPTION OF DRAWINGS

[0020] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings needed in the embodiment description will be briefly introduced below, and obviously, the drawings in the following description can be used to obtain other drawings without creative labor for those skilled in the art.

[0021] Among them:

[0022] Figure 1 It is a structure schematic diagram of the interventional valve prosthesis of an embodiment of the present application;

[0023] Figure 2 It is a structure schematic diagram of the interventional valve prosthesis of an embodiment of the present application from another perspective;

[0024] Figure 3Structure schematic view of an endovascular prosthetic valve according to another aspect of an embodiment of the present application;

[0025] Figure 4 Assembly schematic view of an inner stent and a leaflet hook according to an embodiment of the present application;

[0026] Figure 5 Structure schematic view of a leaflet hook according to an embodiment of the present application;

[0027] Figure 6 Structure schematic view of a leaflet hook according to an embodiment of the present application from another aspect;

[0028] Figure 7 Structure schematic view of a leaflet hook according to an embodiment of the present application from another aspect;

[0029] Figure 8 Structure schematic view of a leaflet hook according to another embodiment of the present application;

[0030] Figure 9 Structure schematic view of a leaflet hook according to another embodiment of the present application;

[0031] Figure 10 Structure schematic view of a leaflet hook according to another embodiment of the present application. DETAILED DESCRIPTION

[0032] The technical solutions in the embodiments of the present application will be described clearly and completely below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all the embodiments of the present application. 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.

[0033] In the description of the embodiments of the present application, it should be noted that the orientation or positional relationship indicated by terms such as “center”, “upper”, “lower”, “left”, “right”, “vertical”, “horizontal”, “inner”, “outer” and the like is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the embodiments of the present application and simplifying the description, and therefore cannot be understood as indicating or implying that the device or element must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as a limitation on the embodiments of the present application. In addition, the terms “first”, “second”, “third” are only for the purpose of description, and cannot be understood as indicating or implying relative importance.

[0034] In the description of the embodiments of the present application, it should be noted that unless specifically defined and limited, the terms "mounting", "connecting", "connecting" should be understood in a broad sense, for example, it can be fixedly connected, or it can be replaceably connected, or it can be 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 embodiments of the present application can be understood according to the specific circumstances.

[0035] In the field of interventional medical devices, "axial" generally refers to the length direction of the medical device when it is delivered, "radial" generally refers to the direction of the medical device which is not parallel to its "axial", and the "axial" and "radial" of any component of the medical device are defined according to this principle. "Circumferential" refers to the circumferential direction, i.e. the direction around the axis of the lumen structure, the cylinder.

[0036] Please refer to Figure 1 An embodiment of the present application provides an interventional valve prosthesis 100 which is used to be implanted into the position of the mitral valve to treat mitral stenosis or regurgitation. It can be understood that in other embodiments, it can also be implanted into other positions such as the tricuspid valve, the aortic valve or the pulmonary valve to treat valvular diseases.

[0037] Please continue to refer to Figures 1-2 In an embodiment, the interventional valve prosthesis 100 includes a main support 10, a leaflet hook 20 and a leaflet structure (not shown in the figure).

[0038] Among them, the main support 10 is provided with a lumen 1011, and blood flow can pass through the lumen 1011. The leaflet hook 20 is connected to the main support 10 at one end and has a free end. The free end of the leaflet hook 20 can rotate axially around the main support 10 to approach or move away from the main support 10. The leaflet hook 20 is used to cooperate with the main support 10 to hold the native leaflet when the interventional valve prosthesis 100 is implanted into the valvular lesion position, so as to fix the main support 10 at the lesion position, thereby replacing the native valve. The leaflet structure is arranged in the main support 10, and the leaflet structure can be opened or closed, so that the lumen 1011 presents an open or closed state.

[0039] Please continue to refer to Figures 1-2 In an embodiment, the main support 10 is a double-layer support which includes an inner layer support 101 and an outer layer support 102. The lumen 1011 is formed in the inner layer support 101, and the leaflet structure is arranged on the inner layer support 101. The outer layer support 102 is sleeved outside the inner layer support 101, and there is a buffer gap 1021 between the inner wall of the outer layer support 102 and the outer wall of the inner layer support 101.

[0040] In this way, the outer layer stent 102 is used to fix the human tissue, and the inner layer stent 101 is used to fix the leaflet structure, so that when the valve prosthesis 100 is implanted at a valve structure such as a mitral valve which presents a non-uniform cylindrical shape, the outer layer stent 102 can be deformed to adapt to the shape of the valve structure under the extrusion of the valve structure to anchor, and the buffer gap 1021 between the outer layer stent 102 and the inner layer stent 101 can play a buffering role, so that the inner layer stent 101 can still maintain a cylindrical structure after implantation, thereby avoiding the situation that the extrusion of the valve structure to the main body stent 10 affects the opening and closing of the leaflet structure. It can be understood that in other embodiments, the inner layer stent 101 can be omitted to make the main body stent 10 present a single-layer stent structure, at this time, the lumen 1011 and the leaflet structure are both arranged on the outer layer stent 102.

[0041] Please refer to Figure 3 In an embodiment, the inner layer stent 101 and the outer layer stent 102 are both tubular bare frame structures, which include a plurality of axial struts 11 and a plurality of circumferential struts 12, and the axial struts 11 and the circumferential struts 12 are connected to form a tubular structure with open ends, which can switch between a compressed state and an expanded state.

[0042] In an embodiment, the plurality of circumferential struts 12 are arranged in a staggered manner and connected end to end, thereby forming a plurality of wave-shaped rings 120 arranged along the axial direction of the main body stent 10, and the plurality of wave-shaped rings 120 can be connected by the axial struts 11 or directly connected. In other embodiments, the circumferential struts 12 can also not be connected end to end, for example, the circumferential struts 12 are connected to each other in a staggered manner on the axial struts 11. It can be understood that the number and arrangement of the axial struts 11 and the circumferential struts 12 are not limited, as long as the inner layer stent 101 and the outer layer stent 102 formed by splicing can switch between the compressed state and the expanded state.

[0043] Please continue to refer to FIG. 3 and combine it with Figure 4 In an embodiment, the inner layer stent 101 and the outer layer stent 102 each include three wave-shaped rings 120, and the three wave-shaped rings 120 on the inner layer stent 101 are arranged in the axial direction of the inner layer stent 101 from the distal end to the proximal end (which will be defined in detail below) as a first wave-shaped ring 1201, a second wave-shaped ring 1202, and a third wave-shaped ring 1203, and the three wave-shaped rings 120 on the outer layer stent 102 are arranged in the axial direction of the outer layer stent 102 from the distal end to the proximal end as a fourth wave-shaped ring 1204, a fifth wave-shaped ring 1205, and a sixth wave-shaped ring 1206, wherein the wave-shaped units of the first wave-shaped ring 1201, the second wave-shaped ring 1202, the third wave-shaped ring 1203, the fourth wave-shaped ring 1204, the fifth wave-shaped ring 1205, and the sixth wave-shaped ring 1206 are all “∧”.

[0044] It should be noted that, for the convenience of introduction, in the embodiments of the present application, the distal end and the proximal end are defined based on the direction of blood flow after the implantable valve prosthesis 100 is implanted into the human body, wherein the blood inflow end is defined as the distal end of the implantable valve prosthesis, and the blood outflow end is defined as the proximal end of the implantable valve prosthesis. The same meaning is discussed below and will not be repeated.

[0045] In an embodiment, the crests of the first wave-shaped ring 1201, the second wave-shaped ring 1202, and the third wave-shaped ring 1203 are aligned on the same axis and connected by the axial strut 11, and the troughs of the three are simultaneously aligned on another axis and also connected by the axial strut 11, so that the inner layer stent 10 has good flexibility. It can be understood that, in order to increase the flexibility of the inner layer stent 10, the axial strut 11 can be connected only at the crest position of each wave-shaped ring 120 or only at the trough position of each wave-shaped ring 120.

[0046] In an embodiment, the crests of the fourth wave-shaped ring 1204 and the fifth wave-shaped ring 1205 are aligned on the same axis, the troughs of the fourth wave-shaped ring 1204 and the fifth wave-shaped ring 1205 are aligned on another axis, the axial strut 11 is arranged between the fourth wave-shaped ring 1204 and the fifth wave-shaped ring 1205, one end of the axial strut 11 is connected with the crest or the trough of the fourth wave-shaped ring 1204, the other end extends in the axial direction to connect the crest or the trough of the fifth wave-shaped ring 1205, so as to connect and fix the fourth wave-shaped ring 1204 and the fifth wave-shaped ring 1205. When the outer layer stent 102 is in the expanded state, the gaps between the fourth wave-shaped ring 1204 and the fifth wave-shaped ring 1205 are divided into a plurality of parallelograms by the plurality of axial struts 11. The crests of the sixth wave-shaped ring 1206 and the fifth wave-shaped ring 1205 are aligned on the same axis and directly connected, and the troughs of the sixth wave-shaped ring 1206 and the fifth wave-shaped ring 1205 are aligned on the same axis and separated by a certain distance, so that the sixth wave-shaped ring 1206 and the fifth wave-shaped ring 1205 cooperate to form a plurality of rhombuses when the outer layer stent 102 is in the expanded state. The arrangement of the fourth wave-shaped ring 1204, the fifth wave-shaped ring 1205, and the sixth wave-shaped ring 1206 can make the outer layer stent 102 have good deformability and stability.

[0047] It can be understood that in other embodiments, the shape, number and arrangement of the wave-shaped rings 120 are not limited. For example, in other embodiments, the shape of the wave-shaped rings 120 can be changed by changing the shape of the circumferential strut 12, so that the wave units of the wave-shaped rings 120 present a sine wave shape or other shapes. In other embodiments, the number of wave-shaped rings 120 included in the inner layer stent 101 or the outer layer stent 102 can be 4, 5 or 6 or other integers. In other embodiments, the arrangement of the wave-shaped rings 120 on the inner layer stent 101 can refer to the same arrangement of the wave-shaped rings 120 on the outer layer stent 102, or the arrangement of the wave-shaped rings 120 on the outer layer stent 102 can refer to the same arrangement of the wave-shaped rings 120 on the inner layer stent 101. Alternatively, in other embodiments, the wave crest of the fourth wave-shaped ring 1204 and the wave trough of the fifth wave-shaped ring 1205 can be aligned and separated by a certain distance, and the wave trough of the fourth wave-shaped ring 1204 and the wave crest of the fifth wave-shaped ring 1205 can be aligned and directly connected. The wave crest and wave trough of the sixth wave-shaped ring 1206 are respectively aligned with the wave crest and wave trough of the fifth wave-shaped ring 1205 and connected by the axial strut 11, so that when the outer layer stent 102 is in the expanded state, the fourth wave-shaped ring 1204 and the fifth wave-shaped ring 1205 cooperate to form a plurality of rhombuses, and a plurality of axial struts 11 divide the distance between the fourth wave-shaped ring 1204 and the fifth wave-shaped ring 1205 into a plurality of parallelograms, so that the outer layer stent 102 has better stability while ensuring better deformability.

[0048] Please refer back to Figure 2 and in combination with Figure 3 In an embodiment, one axial strut 11 on the inner layer stent 101 is aligned with one axial strut 11 on the outer layer stent 102 and is fixed by suturing, so that the inner layer stent 101 and the outer layer stent 102 are tangentially arranged. That is, the inner layer stent 101 is arranged in the outer layer stent 102 in an eccentric form, and the shape of the buffer gap 1021 is a non-uniform annular shape. Thus, the interventional valve prosthesis 100 is more suitable for the "D" shape structure (kidney-like structure) of the mitral valve. In other embodiments, the specific shape of the buffer gap 1201 can be changed by changing the connection mode of the inner layer stent 101 and the outer layer stent 102, and the shape of the buffer gap 1201 can be set according to the shape of the actual valve structure to be implanted.

[0049] Please continue to refer to Figure 3In an embodiment, the sixth wave-shaped ring 1206 is a non-complete wave shape, so that a gap is formed on the outer layer stent 102, and the proximal end of the inner layer stent 101 is flush with the distal end of the gap, that is, the inner layer stent 101 does not overlap with the gap in the axial direction. When the interventional prosthetic valve 100 is implanted on the mitral valve, the gap is placed at the position of the anterior leaflet of the mitral valve, so that the influence of the inner layer stent 101 and the outer layer stent 102 on the blood flow from the left ventricle along the aorta can be avoided. It can be understood that the size and position of the gap are not limited, and in other embodiments, the gap can be set according to the blood flow at the implantation target position. When the inner layer stent 101 and the outer layer stent 102 do not affect the blood flow near the target position, the gap can also be omitted. In other embodiments, the proximal end of the inner layer stent 101 can also not be flush with the distal end of the gap, but can extend beyond the distal end of the gap by a portion. At this time, the interventional prosthetic valve 100 can still achieve the effect of not affecting the blood flow from the left ventricle along the aorta, but when the proximal end of the inner layer stent 101 is flush with the distal end of the gap, the gap has the best avoidance effect.

[0050] In an embodiment, the inner layer stent 101 and the outer layer stent 102 are formed by cutting a tubular member, and in other embodiments, the inner layer stent 101 and the outer layer stent 102 can also be formed by splicing the axial struts 11 and the circumferential struts 12 and then fixed by welding. The inner layer stent 101 and the outer layer stent 102 can be made of nickel-titanium alloy, so that the inner layer stent 101 and the outer layer stent 102 have self-expanding properties. In other embodiments, the inner layer stent 101 and the outer layer stent 102 can also be made of metal materials such as cobalt-chromium alloy or stainless steel, and at this time, the inner layer stent 101 and the outer layer stent 102 can be switched from the compressed state to the expanded state by balloon expansion. It can be understood that no matter what material or method is used to form the inner layer stent 101 and the outer layer stent 102, the inner layer stent 101 and the outer layer stent 102 have the property of being switchable between the compressed state and the expanded state.

[0051] Please continue to refer to Figure 3 In an embodiment, the outer layer stent 102 is also provided with barbs 13, which can hook the tissue to assist in fixation when the outer layer stent 102 is implanted at the target position. For example, when the outer layer stent 102 is implanted at the position of the mitral valve, the barbs 13 hook the native leaflet to assist in fixation. In an embodiment, the barbs 13 are formed together with the outer layer stent 102 by cutting a tubular member and then shaping, and in other embodiments, the barbs 13 can be connected to the outer layer stent 102 by welding.

[0052] Please continue to refer to Figure 3 and in combination with Figure 4In an embodiment, the leaflet hook 20 is connected to the inner layer support 101, and the outer layer support 102 is located between the leaflet hook 20 and the inner layer support 101. In other embodiments, the leaflet hook 20 can also be directly connected to the outer layer support 102. It can be understood that the leaflet hook 20 is connected to the inner layer support 101, which is equivalent to moving the connection point of the leaflet hook 20 and the main body support 10 radially inward by a certain distance, and the outer layer support 102 between the leaflet hook 20 and the inner layer support 101 plays a certain filling role, so as to make the distance between the leaflet hook 20 for clamping the natural leaflet and the outer wall of the outer layer support 102 smaller, and thus the natural leaflet can be clamped more stably, avoiding the situation that when the leaflet hook 20 is directly connected to the outer layer support 102, the leaflet hook 20 cannot be tightly attached to the outer layer support 102 due to processing and other factors, resulting in unstable clamping of the natural leaflet.

[0053] Please continue to refer to Figure 4 In an embodiment, the leaflet hook 20 includes a first curved rod 21 and a second curved rod 22.

[0054] The two ends of the first curved rod 21 are connected to the main body support 10, and the middle section of the first curved rod 21 extends along the axial direction of the main body support 10 to form a clamping end. The first curved rod 21 can rotate relative to the main body support 10 in the axial direction to approach the main body support 10 to cooperate with the main body support 10 to capture the natural leaflet, or to move away from the main body support 10, and the first curved rod 21 surrounds a first space. The two ends of the second curved rod 22 are connected to the main body support 10, and the middle section extends along the axial direction of the main body support 10 to form a clamping end located in the first space defined by the first curved rod 21. The second curved rod 21 can rotate relative to the main body support 10 in the axial direction to approach the main body support 10 to clamp the natural leaflet, or to move away from the main body support 10.

[0055] By setting the leaflet hook 20 to include the first curved rod 21 and the second curved rod 22, the first curved rod 21 and the second curved rod 22 can be rotated in the axial direction relative to the main body support 10, and the clamping end of the second curved rod 22 is distributed in the first space surrounded by the first curved rod 21, that is, the clamping end of the second curved rod 22 partitions and blocks the first space defined by the first curved rod 21, so that when the interventional valve prosthesis 100 is fixed on the native valve, the natural leaflet can be first captured between the first curved rod 21 and the main body support 10 by rotating the first curved rod 21, and then the second curved rod 22 is rotated to clamp and abut the natural leaflet located between the first curved rod 21 and the main body support 10, under the blocking effect of the clamping end of the second curved rod 22 on the first curved rod 21, the natural leaflet is stably clamped between the main body support 10 and the leaflet hook 20, and will not escape from the hollow part of the first curved rod 21, so that the situation that the escaped natural leaflet blocks other blood flow channels can be avoided, which is beneficial to the application of the interventional valve prosthesis 100.

[0056] It should be noted that the cooperation of the first curved rod 21 and the second curved rod 22 to capture the natural leaflet means that the natural leaflet is located between the first curved rod 21 and the main body support 10, and the two sides are respectively abutted with the first curved rod 21 and the main body support 10, and the first curved rod 21 and the main body support 10 can exert clamping force on the natural leaflet, or not. When the first curved rod 21 and the main body support 10 exert clamping force on the natural leaflet, the natural leaflet is finally clamped by the cooperation of the first curved rod 21, the second curved rod 22 and the main body support 10, so that the clamping stability is better. When the first curved rod 21 and the main body support 10 do not exert clamping force on the natural leaflet, the first curved rod 21 is equivalent to play a role of pre-positioning the natural leaflet, so as to facilitate the second curved rod 22 to clamp and fix the natural leaflet.

[0057] Please continue to refer to Figure 4 and in combination with Figure 5 In an embodiment, the first curved rod 21 includes an abutting section 211 and a connecting section 212 connected thereto.

[0058] The two connection sections 212 are symmetrically arranged about the abutting section 211, and each of the two connection sections 212 is connected to the main support 10 at one end and connected to one end of the abutting section 211 at the other end after being radially bent. In this way, on the one hand, the abutting section 211 can be deformed by driving the connection section 212 to rotate axially relative to the main support 10, and when the external force applied to the abutting section 211 to move the abutting section 211 away from the main support 10 is removed, the abutting section 211 can automatically move towards the main support 10 under the restoring force of the connection section 212 to collect the native leaflets, so that the implantation operation is simple and convenient. On the other hand, compared with the connection section 212 not being radially bent and being in the form of a straight rod, the flexibility of the bent connection section 212 is better, so that the connection section 212 can be prevented from being broken or disconnected from the main support 10 in the case of multiple rotations of the first curved rod 21.

[0059] Please continue to refer to Figures 4-5 In an embodiment, the connection points of the two connection sections 212 on the main support 10 are circumferentially separated, and the other ends of the two connection sections 212 are connected to the abutting section 211 after being circumferentially away from each other and then close to each other. In this way, the folding radius of the connection section 212 when folded can be further increased, i.e. the flexibility of the connection section 212 is further increased, so that the connection section 212 can be prevented from being broken when repeatedly folded.

[0060] Please continue to refer to 5, in an embodiment, the circumferential width of the abutting section 211 gradually increases from the end connected to the connection section 212 to the end away from the connection section 212, thereby increasing the contact area of the first curved rod 21 with the native leaflets, and further enabling the first curved rod 21 to capture as many native leaflets as possible to increase the clamping stability of the native leaflets. In other embodiments, the circumferential width of the abutting section 211 can first increase and then decrease from the end connected to the connection section 212 to the end away from the connection section 212, so that the circumferential capture width of the first curved rod 21 on the native leaflets is ensured, and the circumferential shape of the first curved rod 21 is more rounded without a sharp end, thereby avoiding the sharp end of the first curved rod 21 puncturing the delivery catheter during transportation.

[0061] Please continue to refer to Figure 5In an embodiment, the second curved rod 22 is provided as one, and two free ends of the second curved rod 22 are connected with two ends of the two connecting segments 212 respectively, which are not connected with the main body support 10, so as to form an indirect connection with the main body support 10. In this way, the movement of the first curved rod 21 can drive the second curved rod 22 to move together, so that when the natural leaflets are to be clamped, only an external force needs to be applied to the first curved rod 21, thereby further simplifying the delivery and release steps of the implantable valve prosthesis 100.

[0062] It can be understood that the abutting segment 211 and the connecting segment 212 of the first curved rod 21 and the second curved rod 22 can be an integral structure; or the abutting segment 211 and the connecting segment 212 are an integral structure, and the second curved rod 22 is connected with the connecting segment 212 in a manner known to those skilled in the art.

[0063] Please continue to refer to Figure 5 In an embodiment, the circumferential width of the second curved rod 22 gradually decreases from one end connected with the connecting segment 212 to the other end away from the connecting segment 212, so that the second curved rod 22 can form a point contact with the natural leaflets, thereby increasing the pressure exerted by the second curved rod 22 on the natural leaflets when in contact with the natural leaflets, i.e. the clamping stability of the natural leaflets is better.

[0064] Please go back to Figure 4 and combine with Figures 6-7 , Figure 6 In the dashed line A represents the center axis of the main body support 10, and the dashed line B represents the axial outer contour line of the main body support 10, Figure 7 In the dashed line C represents the radial outer contour line of the main body support 10, and in an embodiment, the clamping end of the second curved rod 22 is deflected radially towards the side close to the main body support 10 to be located between the main body support 10 and the first curved rod 21. In this way, even if the second curved rod 22 can rotate together with the first curved rod 21, the clamping force exerted by the second curved rod 22 on the natural leaflets is still greater than the clamping force exerted by the first curved rod 21 on the natural leaflets, so that the size of the external force required to drive the first curved rod 21 to flip can be reduced while ensuring the clamping stability of the leaflet hook 20 on the natural leaflets, thereby facilitating the implantation and release of the implantable valve prosthesis 100.

[0065] It is understood that in other embodiments, the second curved rod 22 may also be configured as two, three, or other integer numbers. The two ends of the second curved rod 22 may be directly connected to the main support 10, or one end of the second curved rod 22 may be directly connected to the main support 10, and the other indirectly connected. The second curved rod 22 may also extend circumferentially along the main support 10. The clamping end of the second curved rod 22 may also be located on the same circumferential plane as the clamping end of the first curved rod 21. When the number of second curved rods 22 is greater than or equal to two, the clamping ends of each second curved rod 22 may be located on the same circumferential plane or staggered. That is, the number, shape, and connection method between the second curved rods 22 and the main support 10 are not limited; they only need to satisfy the requirement of being able to divide and block the first space defined by the first curved rod 21 and clamp the natural leaflet.

[0066] For example, such as Figure 8 As shown, in another embodiment, two second curved rods 22 are provided. The two free ends of each second curved rod 22 are connected to the proximal end of the main support 10, and the middle section extends to the distal end along the axial direction of the main support 10 without exceeding the distal end of the first curved rod 21. That is, the circumferential width of the two second curved rods 22 is the same and is smaller than the circumferential width of the first curved rod 21. The distance between the clamping end of the first curved rod 21 and the main support 10 is the same as the distance between the clamping end of the second curved rod 21 and the main support 10, and is smaller than the thickness of the natural leaflet. The two second curved rods 22 are arranged side by side in the first space defined by the first curved rod 21 to divide and block the first space defined by the first curved rod 21, thereby preventing the natural leaflet from escaping from the first space defined by the first curved rod 21.

[0067] Or, such as Figure 9 As shown, in another embodiment, there are still two second curved rods 22. Unlike the previous embodiment, in this embodiment, the circumferential width of one second curved rod 22 is greater than the circumferential width of the other second curved rod 22 and less than the circumferential width of the first curved rod 21. That is, the two second curved rods 22 are radially distributed in the radial direction of the first curved rod 21 to divide and block the first space defined by the first curved rod 21.

[0068] Or, for example Figure 10 As shown, in another embodiment, two second curved rods 22 are still provided. However, unlike the previous two embodiments, in this embodiment, the two free ends of the two second curved rods 22 are connected to the first curved rod 21, and the second curved rods 22 extend circumferentially along the main support 10 to form a clamping end. The two second curved rods 22 are symmetrically arranged about the central axis of the first curved rod 21, thereby dividing and blocking the first space defined by the first curved rod 21.

[0069] Please return Figures 2-3In an embodiment, the prosthetic valve 100 further comprises a skirt support 30. The skirt support 30 is connected to the end of the main support 10 which is not connected to the leaflet hook 20, i.e. the connection point of the skirt support 30 and the connection point of the leaflet hook 20 are distributed on the two ends of the main support 10, and the skirt support 30 extends along the radial direction of the main support 10. The skirt support 30 is used to overlap the tissue when the prosthetic valve 100 is implanted in the valve lesion position, thereby assisting in fixing the prosthetic valve 100, for example, when the prosthetic valve 100 is implanted in the position of the mitral valve, the skirt support 30 overlaps the atrial tissue side of the mitral annulus, thereby cooperating with the leaflet hook 20 to fix the prosthetic valve 100.

[0070] In an embodiment, the skirt support 30 is connected to the outer support 102. The skirt support 30 is connected to the end of the fourth wave-shaped ring 1204 away from the fifth wave-shaped ring 1205. In other embodiments, if the outer support 102 is omitted and the main support 10 is in the form of a single-layer support, the skirt support 30 is connected to the inner support 101.

[0071] Please continue to refer to Figure 2 In an embodiment, the skirt support 30 comprises a plurality of radial support rods 310. Each support rod 310 is connected to the main support 10 at one end and extends along the radial direction of the main support 10 to form a free end at the other end.

[0072] In an embodiment, the free end of the support rod 310 is connected by a plurality of S-shaped rods to form a substantially wavy shape. In this way, the flexibility of the support rod 310 is better, and the flexibility of the free end can play a buffering role when the blood flow impacts, thereby reducing the pressure of the support rod 310 on the atrial tissue and improving the compliance of the free end of the support rod 310.

[0073] Please continue to refer to Figure 2 In an embodiment, the skirt support 30 further comprises a plurality of connecting rods 320. The connecting rod 320 is connected to the main support 10 at one end and connected to the support rod 310 at the other end, and the connecting rod 320 is used to realize the connection between the main support 10 and the support rod 310. In an embodiment, the end of the connecting rod 320 connected to the main support 10 is connected to the peak of the fourth wave-shaped ring 1204, and the two connecting rods 320 are a group, and the two connecting rods 320 in the same group are connected to the same support rod 310, thereby forming a "V-shaped structure" with the two connecting rods 320, thereby increasing the contact area when the skirt support 30 abuts against the tissue while ensuring the compliance of the skirt support 30, and ensuring the stability of the skirt support 30 when abutting against the tissue.

[0074] Please continue to refer to Figure 3In an embodiment, the clamping end of the first curved rod 21 extends along the axial direction of the main body support 10 to abut against the skirt support 30, and then continues to extend along the radial direction of the skirt support 30. Thus, the first curved rod 21 can also play a certain supporting role, further increasing the stability of the implanted transcatheter valve prosthesis 100. For example, when the transcatheter valve prosthesis 100 is implanted into the mitral valve, the distal end of the first curved rod 21 can effectively adhere to the left ventricular side of the mitral annulus, thereby preventing the transcatheter valve prosthesis 100 from being impacted by the blood flow into the left atrium during left ventricular contraction.

[0075] Please go back to Figure 1 It should be noted that the skirt 40 is arranged on the inner layer support 101, the outer layer support 102, and the skirt support 30, and the skirt 40 is wrapped on the inner layer support 101, the outer layer support 102, and the skirt support 30 to guide the blood flow to circulate in the lumen 1011. It can be understood that in an embodiment, the skirt 40 on the inner layer support 101 and the outer layer support 102 is connected and seals the buffer gap 1021, thereby preventing the blood flow from flowing out of the buffer gap 1021, and the skirt 40 wrapped on the skirt support 30 is in a ring shape. The skirt 40 can be fixed on the main body support 10 and the skirt support 30 by a suture. The skirt 40 can be made of polyethylene terephthalate material, or can be made of felt cloth material, and the material of the skirt 40 is not limited to the materials mentioned above, and any flexible material suitable for implanting into the human body and capable of blocking blood flow can be selected. The suture can be made of polyester, polypropylene, polytetrafluoroethylene, and other high molecular materials, and the suture is not limited to the materials mentioned above.

[0076] It should be noted that in an embodiment, the leaflet structure includes three openable or closable valve leaflets, and the valve leaflets are connected to the inner wall of the main body support 10. When the transcatheter valve prosthesis 100 is implanted into the body, the three valve leaflets open and close (or close and open) with the diastole and systole of the heart, thereby closing or opening the lumen 1011. The material of the leaflet can be biological material or high molecular material. In other embodiments, the number of valve leaflets is not limited to three, for example, it can be two or four.

[0077] The technical features of the above-described embodiments can be combined in any manner. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described, but as long as the combinations of the technical features do not conflict, they should be considered as falling within the scope of the present disclosure.

[0078] The above disclosure is only the preferred embodiments of the present application, and of course cannot limit the scope of the present application, therefore, any equivalent changes made according to the claims of the present application still fall within the scope of the present application.

Claims

1. An interventional valve prosthesis, characterized in that, The intervention valve prosthesis comprises a main support and a leaflet hook, the main support is provided with a lumen, the leaflet hook comprises: a first curved rod, both ends of the first curved rod are connected with the main support, and the middle section extends along the axial direction of the main support to form a clamping end, the first curved rod can rotate relative to the main support in the axial direction to approach or move away from the main support, and the first curved rod surrounds a first space; and a plurality of second curved rods, both ends of the second curved rods are respectively connected with the main support and / or the first curved rod, and the middle section extends along the axial direction or the circumferential direction of the main support to form a clamping end located in the first space, the second curved rods can rotate relative to the main support in the axial direction to approach or move away from the main support.

2. The interventional valve prosthesis of claim 1, characterized in that The first curved rod comprises an abutting section and two connecting sections, the two connecting sections are symmetrically arranged about the abutting section, one end of each of the two connecting sections is connected with the main support, and the other end is connected with one end of the abutting section after being radially bent.

3. The interventional valve prosthesis of claim 2, characterized in that The connecting points of the two connecting sections on the main support are circumferentially separated, and the other ends of the two connecting sections are connected with the abutting section after being circumferentially away from each other and then approaching each other.

4. The interventional valve prosthesis of claim 2, characterized in that The circumferential width of the abutting section gradually increases or first increases and then decreases from one end connected with the connecting section to the other end away from the connecting section.

5. The interventional valve prosthesis of claim 2, wherein, Both ends of the second curved rod are connected with the other ends of the two connecting sections not connected with the main support, and the clamping end of the second curved rod is deflected to the side close to the main support to be located between the main support and the clamping end of the first curved rod.

6. The interventional valve prosthesis of claim 1, wherein, The circumferential width of the second curved rod gradually decreases from one end connected with the main support or the first curved rod to the other end away from the main support or the first curved rod.

7. The interventional valve prosthesis of claim 1, characterized in that The intervention valve prosthesis further comprises a skirt support connected with the main support and extending in the radial direction, the connecting ends of the skirt support and the leaflet hook with the main support are respectively located at the two axial opposite ends of the main support, and the first curved rod extends along the axial direction of the main support to abut against the skirt support and then extends radially along the skirt support.

8. The interventional valve prosthesis of claim 1, characterized by The main support comprises a nested inner layer support and outer layer support, the lumen is arranged on the inner layer support, and a buffer gap is arranged between the outer wall of the inner layer support and the inner wall of the outer layer support.

9. The interventional valve prosthesis of claim 8, characterized in that The buffer gap is a non-uniform annular shape.

10. The interventional valve prosthesis of claim 8, characterized by The leaflet hook is connected with the inner layer support, and the outer layer support is located between the leaflet hook and the inner layer support.

11. The interventional valve prosthesis of claim 8, characterized by The outer layer support is further provided with a notch, and the inner layer support does not overlap with the notch in the axial direction.

12. The interventional valve prosthesis of any one of claims 1-11, characterized in that, The intervention valve prosthesis further comprises a leaflet structure arranged on the main support, and the leaflet structure can be opened or closed to make the lumen in an open or closed state.

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