A heart valve prosthesis

Abstract

The present invention discloses a heart valve prosthesis, comprising a stent and a valve, wherein the stent comprises a main body for supporting the valve and a frame for fixing the main body. The present invention fixes the main body and the valve at the valve ring through the frame, replaces the native valve, and realizes the function of opening and closing the blood channel. At the outflow tract, the first ventricular section of the frame is far away from the outflow tract, and the longitudinal dimension of the frame against the atrium and the valve ring is small, so the influence of the valve prosthesis on the heart function can be reduced, thereby preventing conduction block; since the valve leaflet is located in the main body of the stent, the radial dimension of the main body is small, so the size of the artificial valve leaflet is small, which improves the fatigue resistance of the valve leaflet; at the same time, since the overall size of the valve prosthesis is reduced, the pressure grip space of the outflow tract is saved, the size of the required delivery system is reduced, and it is easy to load and transport.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a heart valve prosthesis for implantation in the heart. Background Art

[0002] The heart contains four chambers. The left atrium and left ventricle are located on the left side of the heart, and the right atrium and right ventricle are located on the right side of the heart. The ventricular inflow tract is formed between the atrium and the ventricle, the left ventricular outflow tract is formed by the left ventricle and the aorta, and the right ventricle and the pulmonary artery form the right ventricular outflow tract. There are valves with "one-way valve" functions at the left ventricular inflow tract and the left ventricular outflow tract to ensure the normal flow of blood in the heart chamber. When there is a problem with the valve, the heart's hemodynamics changes and the heart function is abnormal, which is called valvular heart disease.

[0003] Mitral regurgitation can lead to myocardial remodeling, progressive ventricular enlargement, and eventually heart failure. Transcatheter mitral valve replacement (TMVR) uses a catheter intervention method to compress the artificial valve into a delivery system outside the body, deliver it to the human mitral valve ring, and release and fix the artificial valve to the mitral valve ring to replace the native valve. Compared with surgical operations, TMVR does not require an extracorporeal circulation assist device, has less trauma, and allows patients to recover quickly. The hemodynamic indicators of patients can be significantly improved after surgery.

[0004] Although mitral valve replacement technology has developed rapidly, there are still some recognized difficulties in valve design, such as:

[0005] 1. The structure of the atrioventricular valve assembly is complex. If the height of the prosthetic valve is too high, it will affect the native heart structure and function, touch the abnormal cardiac tissue such as the papillary muscle, and easily cause left ventricular outflow tract obstruction (LVOT), inducing adverse postoperative effects.

[0006] 2. Compared with the aortic valve, the native annulus diameter of the mitral valve is larger, and accordingly, the leaflet area of ​​the artificial valve must also be large.

[0007] The tricuspid valve also has the problem of outflow obstruction. Most existing valve stents are single-layer structures. The single-layer stent corresponds to a large leaflet area, and the larger the leaflet area, the worse the fatigue resistance. At the same time, the larger the leaflet area, the larger the stent size required, and the diameter of the catheter used to deliver the valve prosthesis will also be large, increasing the difficulty of delivery and the risk of vascular damage. Summary of the invention

[0008] The present invention provides a heart valve prosthesis, which can solve the above-mentioned defects in the prior art.

[0009] The technical solution of the present invention is as follows:

[0010] A heart valve prosthesis, comprising a valve and a stent;

[0011] The stent comprises a main body portion for supporting the valve and a frame portion for fixing the main body portion at the native valve ring, wherein the main body portion is connected to the frame portion;

[0012] The frame portion includes an atrial segment deployed in the atrium, a valve ring segment deployed at the valve annulus, and a ventricular segment deployed in the ventricle; the ventricular segment includes a first ventricular segment located on the side close to the outflow tract; the distance between the first ventricular segment and the axis of the frame portion is R1, wherein R1 gradually decreases in a linear or nonlinear manner from the atrium to the ventricle. The first ventricular segment gradually moves away from the outflow tract, and the longitudinal dimension of the frame portion against the atrium and the valve ring is small, so as to reduce the influence of the valve prosthesis on the heart function and prevent conduction block.

[0013] Since the valve is located in the main body of the stent, the radial dimension of the main body is smaller than that of the existing single-layer stent, so the size of the artificial valve leaflet is smaller, which improves the fatigue resistance of the valve leaflet; and, since the radial dimension of the main body is smaller, the overall size of the valve prosthesis becomes smaller, which is easier to load and transport.

[0014] Preferably, the angle between the tangent of the first ventricular segment and the axial direction is α, and α is an acute angle; preferably, the angle α is in the range of 30° to 60°. If the angle α is too small, the first ventricular segment 2131 deviates from the outflow tract too little, increasing the risk of outflow tract obstruction; if the angle α is too large, the resistance of the crimping will increase, so the angle α is preferably in the range of 30° to 60°.

[0015] Preferably, the main body and the frame are an inner-outer nested structure, the main body is sleeved inside, and the distance between the axis of the main body and the axis of the frame is r, wherein r is greater than 0. The main body and the frame are fixed in an eccentric manner, and the main body is away from one side of the outflow tract, further reducing the risk of outflow tract obstruction. Studies have shown that if the artificial mitral valve can drive blood to flow along the side wall of the ventricle, the blood can turn smoothly and generate a large vortex, thereby ejecting blood to the aorta and then flowing to the whole body. For a heart valve with an eccentric structure, because the leaflets are located on the stent body, and the stent body is biased toward one side of the ventricular wall, the blood flow will tend to flow along the side wall of the ventricle, which is more beneficial to maintain the natural "blood flow vortex" of the left atrium, thereby promoting the recovery of ventricular function, especially in fragile patients with severely damaged heart conditions.

[0016] Preferably, the main body is away from the outflow channel and abuts against the frame part. The abutment between the two can produce more connection points, which is convenient for the fixed connection between the two and makes the main body as far away from one side of the outflow channel as possible, reducing the risk of blockage of the outflow channel.

[0017] Preferably, the frame portion and the main body portion are parallel structures on the left and right, wherein the frame portion is located close to the outflow channel side, and the main body portion is located outside the frame portion, the frame portion and the outer peripheral side of the main body portion abut against each other, and are connected at the abutting point. With such a structure, the frame portion and the main body portion can produce more connection points, so the connection between the two will be more secure, and further, the main body portion can be moved away from the outflow channel side as far as possible, further reducing the risk of outflow channel blockage.

[0018] Preferably, the frame portion is a non-enclosed structure, which can reduce the material used for the stent and makes it easier to press and grip the valve prosthesis.

[0019] In a preferred embodiment, the frame portion is an open structure along the axial direction, and the frame portion is connected to the outer peripheral side of the main body portion at the opening. The non-closed structure can reduce the material of the stent. Since the material is reduced, the valve prosthesis is easier to press, grasp and transport.

[0020] Preferably, the stent further comprises a fixing portion fixed to the delivery system, the fixing portion being arranged at the end of the main body portion or at the end of the frame portion. The fixing portion is connected to the delivery system for loading and releasing the valve prosthesis from the delivery system, and ensuring that the valve prosthesis does not move during transportation in the delivery system.

[0021] Preferably, the valve comprises an artificial leaflet, which is arranged in the main body, one end of which is connected to the main body, and the free ends of which are joined.

[0022] When the valve is in working condition, artificial valve leaflets replace the original valve leaflets to achieve the function of opening and closing the blood channel.

[0023] Preferably, the stent is also provided with a skirt for sealing. The skirt is used to achieve a sealing function, ensuring that a single channel of blood flows from the inflow end of the valve prosthesis to the outflow end of the valve prosthesis, which can effectively prevent paravalvular leakage and regurgitation.

[0024] Compared with the prior art, the present invention has the following beneficial effects:

[0025] First, the present invention fixes the main body and the valve at the native valve ring of the inflow tract through the frame part, replacing the native valve to achieve the function of opening and closing the blood channel. Near the outflow tract, the first ventricular segment of the frame part is far away from the outflow tract, the longitudinal dimension of the frame part against the atrium and the valve ring is small, and the main body is also far away from the outflow tract to the maximum extent, which can reduce the influence of the valve prosthesis on the heart function, thereby preventing conduction block.

[0026] Second, since the leaflets are located in the main body of the stent, the radial dimension of the main body is smaller than that of the existing single-layer stent, so the size of the artificial leaflets is smaller, which improves the fatigue resistance of the leaflets; at the same time, since the radial dimension of the main body is smaller, the overall size of the valve prosthesis becomes smaller, saving the compression and gripping space of the outflow tract, reducing the size of the required delivery system, and facilitating loading and delivery.

[0027] Third, when there is a predetermined distance between the axes of the main body and the frame, that is, an eccentric structure, or when the main body and the frame are connected left and right, when used as a mitral valve, because the stent body is biased toward one side of the ventricular wall, the blood flow will tend to flow along the ventricular side wall, which is more beneficial to maintain the natural "blood flow vortex" of the left atrium, thereby promoting the recovery of ventricular function, especially in fragile patients with severely damaged heart conditions.

[0028] Fourth, when the main body and the frame are connected left and right, the material of the stent can be reduced; when the frame is a non-closed structure, the material of the stent can be further reduced. Since the material is reduced, it is easier to press, load and transport the valve prosthesis.

[0029] Of course, any product implementing the present invention does not necessarily need to achieve all of the advantages described above at the same time. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 is a schematic diagram of the overall structure of the bracket of Example 1 of the present invention;

[0031] Figure 2 is a schematic structural diagram of the frame portion of Example 1 of the present invention;

[0032] Figure 3 is a schematic diagram of the structure of the valve prosthesis of Example 1 of the present invention being delivered into the heart;

[0033] Figure 4 is a schematic perspective view of a bracket according to Example 1 of the present invention;

[0034] Figure 5 is a schematic structural diagram of the main body of Example 1 of the present invention;

[0035] Figure 6 is a schematic top view of the main body of Example 1 of the present invention;

[0036] Figure 7 is a schematic diagram of the top view of the structure of the bracket of Example 1 of the present invention;

[0037] Figure 8 is another schematic diagram of the top view of the structure of the bracket of Example 1 of the present invention;

[0038] Fig. 9is a schematic diagram of a bracket and an anchoring structure of Example 1 of the present invention;

[0039] Fig.10 is a schematic top view of a bracket and an anchoring structure according to Embodiment 1 of the present invention;

[0040] Fig.11 is a schematic structural diagram of a bracket according to Embodiment 2 of the present invention;

[0041] Fig.12 is a schematic structural diagram of a bracket according to Example 2 of the present invention;

[0042] Fig.13 is a top view of the frame portion of Example 3 of the present invention;

[0043] Fig.14 It is a schematic structural diagram of the bracket of Example 3 of the present invention.

[0044] Figure numerals: stent 100; main body 110; frame 210; atrial segment 211; valve ring segment 212; ventricular segment 213, first ventricular segment 2131; second ventricular segment 2132; inflow segment 111; outflow segment 113; transition segment 112; hanging ear 114; fixing ear 214. DETAILED DESCRIPTION

[0045] The present invention provides a heart valve prosthesis, comprising a valve and a stent for fixing the valve at a native valve ring; the stent comprises a main body portion for supporting the valve and a frame portion for fixing the main body portion, the main body portion being connected to the frame portion, wherein on the side close to the outflow tract, the longitudinal dimension of the frame portion against the atrium and the valve ring is small, and when the first ventricular segment extends toward the main body portion, the influence of the valve prosthesis on the heart function can be reduced to prevent conduction block.

[0046] The heart valve prosthesis of the present invention is applicable to mitral valve and tricuspid valve. As described herein, when the valve prosthesis is a mitral valve, it is fixed at the native valve ring of the left ventricular inflow tract, and the term "outflow tract" here refers to the left ventricular outflow tract. When the valve prosthesis is a tricuspid valve, it is fixed at the native valve ring of the right ventricular inflow tract, and the term "outflow tract" here refers to the right ventricular outflow tract.

[0047] The present invention is further described below by taking the mitral valve as an example.

[0048] In order to more clearly describe the structural features of the present invention, "proximal" and "distal" are used as directional words, wherein "proximal" refers to the end close to the apex during surgery; and "distal" refers to the end away from the apex.

[0049] As used herein, "longitudinal height" refers to the dimension of a component along the axial direction of the valve prosthesis. As used herein, "valve prosthesis" has the same meaning as "heart valve prosthesis". As used herein, "valve", when used alone, refers to a plurality of artificial valve leaflets fixed to the circumference of the main body. As used herein, "left ventricular outflow tract" has the same meaning as LVOT.

[0050] In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", and "third" are used for descriptive purposes only, and cannot be understood as indicating or implying relative importance.

[0051] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0052] As used in this specification, the singular forms "a", "an", and "the" include plural objects, unless the content clearly indicates otherwise. As used in this specification, the term "or" is generally used in a sense including "and / or", unless the content clearly indicates otherwise.

[0053] The implant proposed by the present invention is further described in detail below in conjunction with the accompanying drawings and specific embodiments. It should be noted that the accompanying drawings are all in very simplified form and use non-precise proportions, which are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention. It should be understood that these embodiments are only used to illustrate the present invention and are not used to limit the scope of protection of the present invention. In practical applications, improvements and adjustments made by those skilled in the art according to the present invention still belong to the scope of protection of the present invention.

[0054] Example 1

[0055] This embodiment provides a mitral heart valve prosthesis, see Figure 1-Figure 10 , is a schematic diagram of the valve prosthesis of this embodiment, wherein the valve prosthesis includes a valve and a stent 100.

[0056] The stent 100 includes a main body 110 for supporting a valve and a frame 210 for fixing the main body 110, the main body 110 is connected to the frame 210; the frame 210 includes an atrial segment 211 deployed in the atrium, a valve ring segment 212 deployed at the valve ring, and a ventricular segment 213 deployed in the ventricle, the valve ring segment 212 is located between the atrial segment 211 and the ventricular segment 213. The ventricular segment 213 includes a first ventricular segment 2131 and a second ventricular segment 2132, the first ventricular segment 2131 is located on a side close to the left ventricular outflow tract, and the second ventricular segment 2132 is located on a side away from the left ventricular outflow tract.

[0057] On the side close to the left ventricular outflow tract, the atrial segment 211 and the valve ring segment 212 are respectively against the atrium and the valve ring, and the corresponding height is L1. Figure 2 , Figure 4 On the side away from the left ventricular outflow tract, the height of the frame portion 210 is L2, wherein L1 is smaller than L2; and the first ventricular segment 2131 is configured to extend away from the left ventricular outflow tract to reduce the effect of the valve prosthesis on the heart function and prevent conduction block.

[0058] See also Figure 3 The main body 110 and the valve are fixed to the annulus of the left ventricular inflow tract through the frame part 210 to replace the native valve. On the left ventricular outflow tract side, the longitudinal dimension of the frame part 210 against the atrium and the annulus is small, and the first ventricular segment 2131 of the frame part 210 is far away from the left ventricular outflow tract, thereby reducing the influence of the valve prosthesis on the heart function and preventing conduction block. At the same time, the leaflets of this embodiment are located in the main body of the stent. Compared with the single-layer stent, the radial dimension of the main body is smaller, so the size of the artificial leaflets is smaller, which improves the fatigue resistance of the leaflets. In addition, due to the small radial dimension of the main body, the overall size of the valve prosthesis becomes smaller, which is easy to load and transport.

[0059] See also Figure 2 , Figure 4 , the distance between the first ventricular segment 2131 and the axis BB of the frame portion 210 is R1, and the distance between the second ventricular segment 2132 and the axis BB of the frame portion 210 is R2. In one embodiment, from the atrium to the ventricle, R1 gradually decreases in a linear manner, while R2 remains unchanged, and at this time the first ventricular segment 2131 is a sloped surface. Of course, in other embodiments, R1 can also be gradually reduced in a nonlinear manner, such as when the first ventricular segment 2131 is an arcuate surface, which can also reduce the risk of left ventricular outflow tract obstruction. When the first ventricular segment 2131 is an arcuate surface, R1 refers to the distance from the tangent of a predetermined point on the arcuate surface to the axis.

[0060] The angle between the tangent line of the first ventricular segment 2131 and the axial direction is α, which is an acute angle. If the angle α is too small, the first ventricular segment 2131 deviates from the outflow tract too little, increasing the risk of outflow tract obstruction. If the angle α is too large, the resistance to crimping will increase. Therefore, the angle α is preferably within the range of 30° to 60°.

[0061] In this embodiment, the main body 110 and the frame 210 are an inner and outer nested structure, the main body 110 is set inside, and the frame 210 is set outside. The distance between the axis AA of the main body 110 and the axis BB of the frame 210 is r, where r is greater than 0. Figure 4 That is, the main body 110 and the frame 210 are eccentrically designed, and the main body 110 deviates away from the left ventricular outflow tract, which can further reduce the risk of left ventricular outflow tract obstruction.

[0062] The size of r determines the degree of eccentricity of the main body 110. The smaller r is, the smaller the degree of deviation is, and the larger r is, the greater the degree of eccentricity of the main body 110 is. Preferably, in this embodiment, the main body 110 is away from the left ventricular outflow tract and reaches the frame part 210. Figure 1 , Figure 3 , Figure 4 , Fig. 9 At this time, r is maximum, and the outer peripheral side of the main body 110 abuts against the frame 210. The outer peripheral side of the main body 110 abuts against the frame 210 to generate more connection points, which is convenient for the fixed connection between the two, and makes the main body as far away from the outflow channel as possible, reducing the risk of outflow channel blockage.

[0063] At the same time, studies have shown that if the artificial mitral valve can drive blood to flow along the side wall of the ventricle, the blood can turn smoothly and generate a large vortex, which will shoot the blood to the aorta and then flow to the whole body. The eccentric structure of the heart valve, because the valve leaflets are located on the stent body, and the stent body is biased towards the side of the ventricular wall, the blood flow will tend to flow along the side wall of the ventricle, which is more beneficial to maintain the natural "blood flow vortex" of the left atrium, thereby promoting the recovery of ventricular function, especially in fragile patients with severely damaged heart conditions.

[0064] In this embodiment, the connection between the frame portion 210 and the main body portion 110 can be connected by riveting, welding, snapping, sewing, or bonding with an adhesive, etc., and it should be ensured that no relative displacement occurs between the main body portion 110 and the frame portion 210. The specific connection method can be selected based on the materials and molding methods of the frame portion 210 and the main body portion 110, and is not limited here.

[0065] like Figure 5, which is a schematic diagram of the structure of the main body 110 of this embodiment. The main body 110 includes an inflow section 111, an outflow section 113, and a transition section 112 located therebetween. The main body 110 is an elliptical cylinder. Of course, in other embodiments, the main body 110 can also be a cylinder, such as Figure 7 The cross-sectional shape of the main body 110 can be circular, or quasi-circular, D-shaped, flower-shaped or other irregular shapes. Quasi-circular refers to hexagons and polygons with more than six sides, which are close to circles in nature. Flower-shaped Figure 6 shown.

[0066] The main body 110 is configured as a mesh structure having several rows of component units. In this embodiment, the component units are diamond-shaped structures, which have the advantages of simple molding process and a smoother diamond mesh surface. Of course, in other embodiments, the component units can also be mesh units that can form closed shapes such as triangles, squares, pentagons, quasi-circular, and teardrop shapes, and squares include rectangles and squares. Among them, the shape, size, and number of rows of the component units should be selected according to the material, process, etc. of the main body.

[0067] The main body 110 may be made of a self-expanding or plastically deformable material, such as a balloon expandable material, or may be a shape memory alloy that responds to temperature changes to transition between a contracted delivery state and an expanded deployment state. Specifically, the main body 110 may be made of nitinol, titanium alloy, cobalt-chromium alloy, MP35n, 316 stainless steel, L605, Phynox / Elgiloy, platinum-chromium, or other biocompatible metals known to those skilled in the art. Preferably, the main body 110 of this embodiment is manufactured by cutting nickel-titanium alloy tubing, and the process is more mature and reliable, wherein the outer diameter of the tubing is 5 to 15 mm, and the outer diameter of the tubing is the size in the natural state, and the diameter size after shaping should be selected according to actual needs.

[0068] Continue to see Figure 2 The frame portion 210 is a cylindrical structure, wherein the radial dimension of the atrial segment 211 is large, the ventricular segment 213 is an asymmetric structure, and the cross section of the frame portion 210 is circular or D-shaped. Of course, in other embodiments, the frame portion 210 may also be a cone, or a combination of a cylinder and a cone, and the cross section of the frame portion 210 may also be a quasi-circular, D-shaped, flower-shaped, or other irregular shapes, or a combination of multiple shapes.

[0069] The frame part 210 is configured as a mesh structure having several rows of component units. In this embodiment, the component units are diamond structures. Of course, in other embodiments, the component units can also be triangles, diamonds, pentagons, quasi-circles, water droplets, etc., which can form closed grid units. The shape, size, and number of rows of the component units should be selected according to the material, process, etc. of the main body.

[0070] The frame portion 210 can be made of materials such as nitinol, titanium alloy, cobalt-chromium alloy, MP35n, 316 stainless steel, L605, Phynox / Elgiloy, platinum-chromium, or other biocompatible metals known to those skilled in the art. Optionally, it also includes elastically or plastically deformable materials, such as balloon expandable, or shape memory alloys that respond to temperature changes to transition between a contracted delivery state and an expanded deployment state. Preferably, the frame portion 210 of this embodiment is woven from nickel-titanium alloy. In other optional embodiments, the frame portion 210 can be made of a material with relatively low stiffness. This can further reduce the impact of the valve prosthesis on cardiac function.

[0071] Furthermore, the stent 100 also includes a fixing portion fixed to the delivery system, the fixing portion is connected to the delivery system, such as connected to the delivery sheath, to ensure that the relative position of the valve prosthesis and the delivery system remains unchanged when the valve prosthesis is loaded into the delivery system, released from the delivery system, and transported in the body. Figure 5 In this embodiment, the fixing part is a lug 114 disposed at the proximal end of the outflow section 113, and the lug 114 is used to connect to the delivery system. Of course, in other embodiments, the fixing part can also be disposed at the distal end of the inflow section 111, or at both the proximal end of the outflow section 113 and the distal end of the inflow section 111.

[0072] In another optional embodiment, the fixing portion further includes a fixing ear 214 disposed at the proximal end of the ventricular segment 213, such as Figure 2 Of course, in other alternative embodiments, the fixing part can also be arranged at the distal end of the atrial segment 211, or at the proximal end of the ventricular segment 213 and the distal end of the atrial segment 211. The fixing part is connected to the delivery system, so the position and number of the fixing part should be selected according to the type of delivery system and the implantation method, which is not limited here.

[0073] The valve prosthesis of this embodiment is a mitral valve prosthesis, and the valve has at least two leaflets, one end of the leaflet is directly or indirectly connected to the main body 110, and the free ends of the leaflets are joined. In the working state, the artificial leaflets replace the native leaflets to realize the function of opening and closing the blood channel. The leaflets can be made of animal pericardium or other biocompatible polymer materials, such as PET or PTFE. The size and material can be selected according to different application scenarios.

[0074] In this embodiment, the stent 100 is also provided with a skirt for sealing. The skirt is used to achieve a sealing function, ensuring that the single channel of blood flows from the inflow end of the valve prosthesis to the outflow end of the valve prosthesis, which can effectively prevent paravalvular leakage and regurgitation. Among them, the skirt can be arranged only on the main body 110, or only on the frame part 210, or the main body 110 and the frame part 210 are arranged at the same time; the skirt can be arranged on one side or on both sides. When the skirt is arranged above the annular area formed by the main body 110 and the frame part 210, it is used to prevent the formation of thrombus in the annular area.

[0075] The material of the skirt is animal pericardium or biocompatible polymer material, animal pericardium such as porcine pericardium and bovine pericardium, and biocompatible polymer material such as PET and PTFE. The area, area and material of the skirt should be set according to actual clinical needs and are not limited here.

[0076] In this embodiment, the anchoring form of the valve prosthesis is not limited, and a flange may be provided on the stent 100, such as Figure 7 , Figure 8 As shown, an oversized anchoring form is adopted; anchoring structures such as thorns and anchor claws can also be set on the stent 100 to grab the native tissue, such as Figure 1 , Figure 3 As shown; it can also be fixed by anchoring the tether to the myocardial wall, or by a combination of multiple methods. Fig. 9 , Fig.10 As shown, the valve prosthesis is fixed by a combination of flange and tether, a flange is provided on the atrial segment 211 of the frame portion 210, a tether is connected to the outflow segment 113 of the main body portion 110, and the tether is anchored to the myocardial wall. The specific anchoring form should be selected according to the actual diagnosis and treatment needs.

[0077] Example 2

[0078] This embodiment provides a valve prosthesis, which is an improvement on the first embodiment, wherein the frame portion 210 and the main body portion 110 are parallel structures on the left and right.

[0079] See also Fig.11 , is a schematic diagram of the overall structure of the bracket 100 of this embodiment, Fig.12It is a schematic perspective view of the stent 100. The main body 110 is a cylinder, and the main body 110 is located outside the frame 210. The outer peripheral side of the frame 210 abuts against the outer peripheral side of the main body 110, and is connected at the abutment. With such a structure, the frame 210 and the main body 110 can generate more connection points, so that the contact area between the frame 210 and the main body 110 is larger, so the connection between the two will be more stable; further, the main body 110 is as far away from the left ventricular outflow tract as possible. And the left-right connection structure, compared with the inside-outside nested structure, can reduce the material of the frame 210, which is convenient for pressing and gripping.

[0080] When the valve prosthesis of this embodiment is implanted, the frame portion 210 should be arranged at a predetermined position close to the left ventricular outflow tract.

[0081] Example 3

[0082] This embodiment provides a valve prosthesis, which is an improvement made on the basis of the first or second embodiment, wherein the frame portion 210 is configured as a non-enclosed structure.

[0083] like Fig.13 FIG. 2 is a top view of the frame portion 210 , which is a non-enclosed structure with a semicircular or C-shaped cross section. The non-enclosed structure can further save the material of the frame portion 210 , making the valve prosthesis easier to crimp, grasp and transport.

[0084] like Fig.14 As shown, it is a schematic perspective view of the bracket of this embodiment, the frame part 210 and the main body part 110 are parallel structures on the left and right, wherein the frame part 210 is an open structure along the axial direction, and the frame part 210 is connected to the outer periphery of the main body part 110 at the opening.

[0085] The various embodiments in this specification are described in a progressive manner, and each embodiment focuses on the differences from other embodiments. The same and similar parts between the various embodiments can be referred to each other. The above description is only a description of the preferred embodiments of the present invention, and is not any limitation on the scope of the present invention. Any changes and modifications made by ordinary technicians in the field of the present invention based on the above disclosure are within the scope of protection of the claims. Obviously, many modifications and changes can be made according to the contents of this specification. This specification selects and specifically describes these embodiments in order to better explain the principles and practical applications of the present invention, so that technicians in the relevant field can make good use of the present invention. The present invention is only limited by the claims and their full scope and equivalents.

Claims

1. A heart valve prosthesis, characterized in that: Including valves and stents; The stent includes a main body portion for supporting the valve and a frame portion for fixing the main body portion at the native valve ring, the main body portion is connected to the frame portion, the main body portion is away from the outflow duct and reaches the frame portion, the distance between the axis of the main body portion and the axis of the frame portion is r, wherein r is greater than 0; the frame portion includes an atrial segment deployed in the atrium, a valve ring segment deployed at the valve ring and a ventricular segment deployed in the ventricle; the ventricular segment includes a first ventricular segment located on a side close to the outflow duct, the distance between the first ventricular segment and the axis of the frame portion is R1, wherein R1 gradually decreases in a linear or nonlinear manner from the atrium to the ventricle.

2. The heart valve prosthesis according to claim 1, characterized in that: The angle between the tangent line of the first ventricular segment and the axial direction is α, and the angle α is in the range of 30° to 60°.

3. The heart valve prosthesis according to claim 1, characterized in that: The main body and the frame are in an inner-outer nested structure, with the main body being sleeved inside; the valve includes artificial leaflets, which are arranged in the main body.

4. The heart valve prosthesis according to claim 1, characterized in that: The frame portion and the main body portion are arranged side by side.

5. The heart valve prosthesis according to any one of claims 1 to 4, characterized in that: The frame portion is a non-enclosed structure.

6. The heart valve prosthesis according to claim 5, characterized in that: The frame portion is an open structure along the axial direction, and the frame portion is connected to the outer peripheral side of the main body portion at the opening.

7. The heart valve prosthesis according to claim 1, characterized in that: The bracket also includes a fixing portion fixed to the conveying system, and the fixing portion is configured at the end of the main body portion or at the end of the frame portion.

8. The heart valve prosthesis according to claim 1, characterized in that: The bracket is also provided with a skirt for sealing.

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