A surgical artificial heart valve

Abstract

The present invention relates to a surgical artificial heart valve, which comprises a first valve and a second valve connected in sequence along the long axis direction. The foot of a conventional surgical artificial heart valve will block the opening of the outflow side of the valve due to muscle tissue squeezing, thereby reducing the effective opening area of ​​the valve. The surgical artificial heart valve provided by the present invention avoids the reduction of the effective opening area caused by muscle tissue squeezing by specifically setting the positions of three first valve feet in the first valve and three second valve feet in the second valve.

Description

Technical Field

[0001] The invention belongs to the technical field of medical devices and relates to a surgical artificial heart valve. Background Art

[0002] Mitral regurgitation is a common mitral valve disease. Treatments for mitral regurgitation patients include repair and replacement. Since the therapeutic effect of repair methods is limited, mitral valve replacement is often required. Traditional replacement products include mechanical valves and bioprosthetic valves.

[0003] Mechanical valves are durable and not prone to wear, but they require lifelong use of anticoagulants to prevent the formation of blood clots, which increases the risk of internal bleeding. Compared with mechanical valves, biological valves have the advantages of less trauma and faster postoperative recovery. For biological valves with a circular overall shape, they are composed of three elastic leaflets that can be opened and closed with pressure. The leaflets are fixed to the valve frame by suturing. The valve frame usually has a certain height and the height of the valve frame increases with the size of the valve.

[0004] CN116616963A discloses an artificial heart valve, comprising at least two incompressible valves; the at least two incompressible valves independently comprise a support seat, a metal frame arranged on the top surface of the support seat, and leaflets attached to the metal frame; two adjacent incompressible valves are connected; and the cross-sectional area of ​​the artificial heart valve is ≤ the sum of the cross-sectional areas of the at least two incompressible valves constituting the artificial heart valve.

[0005] Therefore, in the prior art, surgical double-hole mitral valves disperse the pressure on a single valve by splitting a valve with a larger opening into two valves with smaller openings, thereby improving the durability of the valve. At the same time, the two smaller openings are arranged closely together, and the shape is similar to an ellipse, which is more in line with the shape of the native mitral valve ring, reducing the impact of the artificial biological mitral valve on the aortic valve after implantation.

[0006] However, patients with mitral valve disease have problems with compensatory hyperplasia of ventricular muscle. When a double-orifice mitral valve is implanted, the valve feet on the long axis of the outflow side will come into contact and squeeze with the anterior and posterior walls of the ventricle. This contact and squeezing will limit the movement of the valve leaflets to a certain extent. The contact between the valve feet and the ventricle will also accelerate the extension of scar tissue on the valve leaflets.

[0007] To this end, it is necessary to avoid the problem of reducing the effective opening area of ​​the valve due to compression between the valve legs and the surrounding tissues. Summary of the invention

[0008] The object of the present invention is to provide a surgical artificial heart valve, which avoids the problem of reduction of effective opening area caused by muscle tissue compression by specifically setting the position of the valve foot.

[0009] In order to achieve the purpose of the invention, the present invention adopts the following technical solutions:

[0010] The present invention provides a surgical artificial heart valve, the surgical artificial heart valve comprising a first valve and a second valve connected in sequence along a long axis direction;

[0011] The first valve comprises a first support seat, three first valve petal feet arranged on the outflow side of the first support seat, and a first leaflet attached to the three first valve petal feet; the three first valve petal feet are evenly distributed on the outflow side of the first support seat;

[0012] The second valve comprises a second support seat, three second valve petal feet arranged on the outflow side of the second support seat, and a second leaflet attached to the three second valve petal feet; the three second valve petal feet are evenly distributed on the outflow side of the second support seat;

[0013] Among the three first valve petals and the three second valve petals, the distance between the first valve petal and the second valve petal closest to each other is a, and a≤3mm; among the other two first valve petals and the other two second valve petals, the distance between any first valve petal and the second valve petal closest to it is b 1 mm, the distance between the other first valve foot and the second valve foot closest to it is b 2 mm, and the inner diameter of the first support seat is d 1 mm, the inner diameter of the second support seat is d 2 mm, then d 1 1 <2d 1 , d 2 2 <2d 2 .

[0014] Because patients with mitral valve disease have compensatory hyperplasia of ventricular muscles, the flap feet of conventional surgical artificial heart valves have the defect of limiting the movement of valve leaflets when they come into contact and squeeze the anterior and posterior walls of the ventricle. The present invention makes the distance between one of the three flap feet of the first valve and one of the three flap feet of the second valve close, while the distance between the other two flap feet of the first valve and the other two flap feet of the second valve exceeds the inner diameter of the first support seat or the second support seat, so that when the flap feet interfere with the muscle tissue, the two flap feet can form a surface from both sides of the long axis direction to block the myocardial tissue from squeezing the valve outflow side opening, thereby ensuring the effective opening area of ​​the valve.

[0015] Preferably, the d 1 ​​The value of is 15-25, for example, it can be 15, 16, 18, 20, 21, 24 or 25, but is not limited to the listed values, and other values ​​not listed in the numerical range are also applicable.

[0016] Preferably, the d 2 The value of is 15-25, for example, it can be 15, 16, 18, 20, 21, 24 or 25, but is not limited to the listed values, and other values ​​not listed in the numerical range are also applicable.

[0017] Preferably, the b 1 With the b 2 Satisfies the following relationship: b 1 =b 2 .

[0018] As a preferred technical solution of the present invention, when b 1 With b 2 The relationship satisfies b 1 =b 2 When the artificial surgical heart valve is in the state of being reconstructed, with the top view of the artificial surgical heart valve as a reference, the distance between a first valve crura in the first valve and a second valve crura in the second valve is the shortest, and the other two first valve crura in the first valve and the other two second valve crura in the second valve form a rectangle. At this time, the opening area of ​​the artificial surgical heart valve can be effectively guaranteed, and the situation in which the crura are surrounded by muscle tissue and the reduction of the effective opening area is greatly avoided.

[0019] Preferably, the first support seat of the first valve is connected to the second support seat of the second valve.

[0020] Preferably, the connection method between the first support seat and the second support seat includes any one of welding, riveting or snap connection, or a combination of at least two of them.

[0021] Preferably, a first arc-shaped belt is provided on a side of the first support seat away from the second support seat;

[0022] and / or,

[0023] A second arc-shaped belt is arranged on a side of the second support base away from the first support base.

[0024] The present invention can further effectively prevent the muscle tissue in the ventricle from interfering with the normal operation of the surgical artificial heart valve by setting the first arc-shaped belt and / or the second arc-shaped belt. The arc-shaped belts arranged on both sides of the long axis direction of the surgical artificial heart valve form a channel on the outflow side, which can effectively optimize the hemodynamics and reduce the formation of thrombus.

[0025] Preferably, the first arc-shaped belt includes a first starting point and a first end point;

[0026] In the second arc-shaped band, the endpoint closest to the first starting point is the second starting point, and the endpoint closest to the second ending point is the second ending point;

[0027] The distance between the first starting point and the second starting point is c 1 mm, c 1 Satisfy: 20≤c 1 ≤40, for example, it can be 25, 25, 30, 35 or 40, but is not limited to the listed values, and other unlisted values ​​within the numerical range are also applicable.

[0028] The distance between the first end point and the second end point is c 2 mm, c 2 Satisfy: 20≤c 2 ≤40, for example, it can be 25, 25, 30, 35 or 40, but is not limited to the listed values, and other unlisted values ​​within the numerical range are also applicable.

[0029] Preferably, the distance between the first starting point and the second starting point is c 1 mm, then c 1 <1.5d 1 ;

[0030] The distance between the first end point and the second end point is c 2 mm, then c 2 <1.5d 2 .

[0031] Preferably, the c 1 With the c 2 Satisfies the following relationship: 1 =c 2 .

[0032] Preferably, the edges of the unsutured portions of the first leaflets are sequentially abutted and joined together to form a first valve structure, the first valve structure forms a small hole in the center of the first valve, and the convex surface of each first leaflet faces the same side;

[0033] The edges of the unsutured parts of the second leaflets are sequentially butted together to form a second valve structure. The second valve structure forms a small hole in the center of the second valve, and the convex surface of each second leaflet faces the same side.

[0034] Compared with the prior art, the present invention has the following beneficial effects:

[0035] The present invention makes the distance between one of the three flap feet of the first valve and one of the three flap feet of the second valve close, while the distance between the other two flap feet of the first valve and the other two flap feet of the second valve exceeds the inner diameter of the first support seat or the second support seat. When the flap feet interfere with muscle tissue, the two flap feet can form a surface from both sides of the long axis direction to block the myocardial tissue from squeezing the outflow side opening of the valve, thereby ensuring the effective opening area of ​​the valve. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] Figure 1 A top view of the structure of the outflow side of the surgical artificial heart valve provided for Comparative Example 1;

[0037] Figure 2 A schematic diagram of the effective opening area when the surgical artificial heart valve provided in Comparative Example 1 is in use;

[0038] Figure 3 A top view of the structure of the outflow side of the surgical artificial heart valve provided in Example 1;

[0039] Figure 4 A schematic diagram of the effective opening area when the surgical artificial heart valve provided in Example 1 is in use;

[0040] Figure 5 A schematic diagram of the structure of a surgical artificial heart valve provided in Example 2;

[0041] Figure 6 This is a schematic structural diagram of the surgical artificial heart valve provided in Example 3.

[0042] Among them: 1, the outermost first valve foot; 2, the outermost second valve foot; 3, the first valve foot B; 4, the first valve foot C; 5, the second valve foot B; 6, the second valve foot C; 10, the first arcuate band; 20, the second arcuate band. DETAILED DESCRIPTION

[0043] The technical solution of the present invention is further described below by specific implementation methods. It should be understood by those skilled in the art that the embodiments are only to help understand the present invention and should not be regarded as specific limitations of the present invention.

[0044] In order to clearly illustrate the technical solution, the distance parameters in the specific implementation of the present invention all ignore the wall thickness of the first support seat, the second support seat, the first valve foot and the second valve foot.

[0045] A certain embodiment of the present invention provides a surgical artificial heart valve, the surgical artificial heart valve comprising a first valve and a second valve connected in sequence along a long axis direction;

[0046] The first valve comprises a first support seat, three first valve petal feet arranged on the outflow side of the first support seat, and a first leaflet attached to the three first valve petal feet; the three first valve petal feet are evenly distributed on the outflow side of the first support seat;

[0047] The second valve comprises a second support seat, three second valve petal feet arranged on the outflow side of the second support seat, and a second leaflet attached to the three second valve petal feet; the three second valve petal feet are evenly distributed on the outflow side of the second support seat;

[0048] Among the three first valve petals and the three second valve petals, the distance between the first valve petal and the second valve petal closest to each other is a, and a≤3mm; among the other two first valve petals and the other two second valve petals, the distance between any first valve petal and the second valve petal closest to it is b 1 mm, the distance between the other first valve foot and the second valve foot closest to it is b 2 mm, and the inner diameter of the first support seat is d 1 mm, the inner diameter of the second support seat is d 2 mm, then d 1 1 <2d 1 , d 2 2 <2d 2 .

[0049] Because patients with mitral valve disease have compensatory hyperplasia of ventricular muscles, the flap feet of conventional surgical artificial heart valves have the defect of limiting the movement of valve leaflets when they come into contact and squeeze the anterior and posterior walls of the ventricle. The present invention makes the distance between one of the three flap feet of the first valve and one of the three flap feet of the second valve close, while the distance between the other two flap feet of the first valve and the other two flap feet of the second valve exceeds the inner diameter of the first support seat or the second support seat, so that when the flap feet interfere with the muscle tissue, the two flap feet can form a surface from both sides of the long axis direction to block the myocardial tissue from squeezing the valve outflow side opening, thereby ensuring the effective opening area of ​​the valve.

[0050] In some embodiments, the material of the first support base includes any one of polyethylene terephthalate (PET), cobalt-chromium-nickel alloy or stainless steel, or a combination of at least two thereof; the stainless steel includes 316L stainless steel or 317L stainless steel.

[0051] The present invention does not specifically limit the connection method between the first support seat, the first leaflet and the first valve foot. Exemplarily, the first support seat, the first leaflet and the first valve foot are connected by a fabric layer.

[0052] ​​Exemplarily, the material of the fabric layer includes polyester and / or polytetrafluoroethylene (PTFE).

[0053] In some embodiments, the material of the second support base includes any one of polyethylene terephthalate (PET), cobalt-chromium-nickel alloy or stainless steel, or a combination of at least two thereof; the stainless steel includes 316L stainless steel or 317L stainless steel.

[0054] The present invention does not specifically limit the connection method between the second support seat, the second leaflet and the second valve foot. Exemplarily, the second support seat, the second leaflet and the second valve foot are connected by a fabric layer.

[0055] Exemplarily, the material of the fabric layer includes polyester and / or polytetrafluoroethylene (PTFE).

[0056] In certain embodiments, the d 1 The value of is 15-25, for example, it can be 15, 16, 18, 20, 21, 24 or 25, but is not limited to the listed values, and other values ​​not listed in the numerical range are also applicable.

[0057] In certain embodiments, the d 2 The value of is 15-25, for example, it can be 15, 16, 18, 20, 21, 24 or 25, but is not limited to the listed values, and other values ​​not listed in the numerical range are also applicable.

[0058] In certain embodiments, the b 1 With the b 2 Satisfies the following relationship: b 1 =b 2 .

[0059] As a preferred technical solution of the present invention, when b 1 With b 2 The relationship satisfies b 1 =b 2 When the surgical artificial heart valve is in the state of being reconstructed, with the top view of the surgical artificial heart valve as a reference, the distance between a first valve crura in the first valve and a second valve crura in the second valve is the shortest, and the other two first valve crura in the second valve and the other two second valve crura in the second valve form a rectangle. At this time, the opening area of ​​the surgical artificial heart valve can be effectively guaranteed, and the situation in which the crura are surrounded by muscle tissue and the reduction of the effective opening area is greatly avoided.

[0060] In some embodiments, the first support seat of the first valve is connected to the second support seat of the second valve.

[0061] In some embodiments, the connection method between the first support base and the second support base includes any one of welding, riveting or snap connection, or a combination of at least two of them.

[0062] In some embodiments, when the connection between the first support base and the second support base is a snap connection, the snap includes an elastic portion.

[0063] The native mitral valve ring is saddle-shaped, and in three-dimensional space, the anterior and posterior leaflets are higher than the junction. During the contraction and relaxation of the heart, the mitral valve ring also moves, and the junction of the inner and outer anterior and posterior leaflets will fold down along the anterior-posterior radial direction of the mitral valve. The present invention can enable the surgical artificial heart valve to still have the conditions for movement after implantation through the provision of the elastic part, and retain the ability of muscle tissue to contract and relax to the greatest extent.

[0064] Exemplarily, the elastic portion includes a spring or a soft connector, and the present invention does not specifically limit this as long as it can achieve relative movement of the first valve and the second valve in a certain space.

[0065] In some embodiments, a first arc-shaped belt is provided on a side of the first support base away from the second support base;

[0066] and / or,

[0067] A second arc-shaped belt is arranged on a side of the second support base away from the first support base.

[0068] The present invention can further effectively prevent the muscle tissue in the ventricle from interfering with the normal operation of the surgical artificial heart valve by setting the first arc band and / or the second arc band. The arc bands arranged on both sides of the long axis direction of the surgical artificial heart valve form channels on the outflow side, which can effectively optimize hemodynamics and reduce the formation of blood clots.

[0069] In some embodiments, the first arcuate band includes a first starting point and a first end point;

[0070] In the second arc-shaped band, the endpoint closest to the first starting point is the second starting point, and the endpoint closest to the second ending point is the second ending point;

[0071] The distance between the first starting point and the second starting point is c 1 mm, c 1 Satisfy: 20≤c 1 ≤40, for example, it can be 25, 25, 30, 35 or 40, but is not limited to the listed values, and other values ​​not listed in the numerical range are also applicable;

[0072] The distance between the first end point and the second end point is c 2 mm, c 2Satisfy: 20≤c 2 ≤40, for example, it can be 25, 25, 30, 35 or 40, but it is not limited to the listed values. Other values ​​not listed in the numerical range are also applicable.

[0073] In some embodiments, the distance between the first starting point and the second starting point is c 1 mm, then c 1 <1.5d 1 , preferably c 1 =0.5d 1 ;

[0074] The distance between the first end point and the second end point is c 2 mm, then c 2 <1.5d 2 , preferably c 2 =0.5d 2 .

[0075] In certain embodiments, the c 1 With the c 2 Satisfies the following relationship: 1 =c 2 .

[0076] In some embodiments, the materials of the first arc-shaped belt and the second arc-shaped belt independently include polymer materials.

[0077] The present invention makes the materials of the first arc-shaped band and the second arc-shaped band independently of each other a polymer material, and the polymer material has a certain hardness, flexibility and elasticity, which can effectively reduce the extension rate of scar tissue, prevent endothelialization of the first leaflet and the second leaflet, and improve the durability of the surgical artificial heart valve.

[0078] Exemplarily, the polymer material includes any one of polypropylene (PP), polyphenylene sulfone (PPSU) or polyethylene terephthalate (PET) or a combination of at least two thereof, preferably PET.

[0079] In some embodiments, the height of the first arcuate band and / or the second arcuate band is smaller than the height of the first valve foot and the height of the second valve foot.

[0080] In some embodiments, the first arcuate belt is a continuous arcuate belt from a first starting point to a first end point, or an interval arcuate belt formed by a multi-segment structure with intervals.

[0081] In some embodiments, the second arc-shaped belt is a continuous arc-shaped belt from the second starting point to the second end point, or an interval arc-shaped belt formed by a plurality of interval structures.

[0082] In some embodiments, the edges of the unsutured portions of the first leaflets are sequentially abutted and joined together to form a first valve structure, wherein the first valve structure forms a small hole in the center of the first valve, and the convex surface of each first leaflet faces the same side;

[0083] The edges of the unsutured parts of the second leaflets are sequentially butted together to form a second valve structure. The second valve structure forms a small hole in the center of the second valve, and the convex surface of each second leaflet faces the same side.

[0084] In the present invention, the structures of the first leaflet and the second leaflet are conventional structures in the art, and the present invention is not specifically limited here. Exemplarily, the material of the first leaflet and the second leaflet includes an elastic material, and the elastic material includes a biological tissue material or a polymer material; further, the biological tissue material includes bovine pericardium or porcine pericardium.

[0085] Comparative Example 1

[0086] This comparative example provides a surgical artificial heart valve, the top view of which is as shown in FIG. Figure 1 As shown, it includes a first valve and a second valve connected in sequence along the long axis direction;

[0087] The first valve comprises a first support seat (316L stainless steel, inner diameter 20 mm), three first valve petals arranged on the outflow side of the first support seat, and a first leaflet (pig pericardium) attached to the three first valve petals; the three first valve petals are evenly distributed on the outflow side of the first support seat, and one of the first valve petals (named as the outermost first valve petal 1) is distributed on the outermost side away from the second valve in the long axis direction; the first support seat, the first leaflet and the first valve petal are connected by a PTFE fabric layer;

[0088] The second valve comprises a second support seat (316L stainless steel, inner diameter 20mm), three second valve petals arranged on the outflow side of the second support seat, and a second leaflet (pig pericardium) attached to the three second valve petals; the three second valve petals are evenly distributed on the outflow side of the second support seat, and one of the second valve petals (named as the outermost second valve petal 2) is distributed on the outermost side away from the first valve in the long axis direction; the second support seat, the second leaflet and the second valve petal are connected by a PTFE fabric layer;

[0089] The first support base and the second support base are connected by welding.

[0090] The edges of the unsutured portions of the first leaflets are sequentially abutted and joined together to form a first valve structure, wherein a small hole is formed in the center of the first valve structure, and the convex surface of each first leaflet faces the same side;

[0091] The edges of the unsutured parts of the second leaflets are sequentially butted together to form a second valve structure. The second valve structure forms a small hole in the center of the second valve, and the convex surface of each second leaflet faces the same side.

[0092] When the surgical artificial heart valve provided in this comparative example is used, the myocardial tissue around the valve foot interferes with it, that is, the myocardial tissue around the valve foot will be squeezed, and then surround the valve foot, thereby blocking the opening of the outflow side of the surgical artificial heart valve, reducing the effective opening area of ​​the valve (such as Figure 2 The shading indicates the surrounding myocardial tissue).

[0093] Example 1

[0094] This embodiment provides a surgical artificial heart valve, the top view of which is as follows Figure 3 As shown, it includes a first valve and a second valve connected in sequence along the long axis direction;

[0095] The first valve comprises a first support seat (316L stainless steel, inner diameter 20 mm), three first valve legs (first valve legs A, first valve legs B 3 and first valve legs C 4) arranged on the outflow side of the first support seat, and a first leaflet (pig pericardium) attached to the three first valve legs; the first support seat, the first leaflet and the first valve legs are connected by a PTFE fabric layer;

[0096] The second valve comprises a second support seat (316L stainless steel, inner diameter 20 mm), three second valve legs (second valve legs A, second valve legs B 5 and second valve legs C 6) arranged on the outflow side of the second support seat, and a second leaflet (pig pericardium) attached to the three second valve legs; the second support seat, the second leaflet and the second valve legs are connected by a PTFE fabric layer;

[0097] Among the three first valve crura and the three second valve crura, the distance between the closest first valve crura A and the second valve crura A is a, and a is 0 mm; among the other two first valve crura and the other two second valve crura, the distance between the first valve crura B3 and its nearest second valve crura B5 is 30 mm, and the distance between the first valve crura C4 and its nearest second valve crura C6 is 30 mm.

[0098] The first support base and the second support base are connected by welding.

[0099] The edges of the unsutured portions of the first leaflets are sequentially abutted and joined together to form a first valve structure, wherein a small hole is formed in the center of the first valve structure, and the convex surface of each first leaflet faces the same side;

[0100] The edges of the unsutured parts of the second leaflets are sequentially butted together to form a second valve structure. The second valve structure forms a small hole in the center of the second valve, and the convex surface of each second leaflet faces the same side.

[0101] When the surgical artificial heart valve provided in this embodiment is used, the myocardial tissue around the valve foot interferes with it, but the four valve feet on both sides of the long axis direction (the first valve foot B3, the first valve foot C4, the second valve foot B5 and the second valve foot C6) form a surface to block the myocardial tissue from squeezing the surgical artificial heart valve, thereby increasing the effective opening area (see Figure 4 , shading indicates surrounding myocardial tissue).

[0102] Example 2

[0103] This embodiment provides a surgical artificial heart valve, such as Figure 5 As shown, the difference from Example 1 is that in this embodiment, a first arc-shaped belt 10 made of PET is provided on the side of the first support seat away from the second support seat, and a second arc-shaped belt 20 made of PET is provided on the side of the second support seat away from the first support seat;

[0104] The first arc-shaped belt 10 includes a first starting point and a first end point;

[0105] In the second arc-shaped belt 20, the endpoint closest to the first starting point is the second starting point, and the endpoint closest to the second ending point is the second ending point;

[0106] The first arc-shaped belt 10 is a continuous arc-shaped belt from a first starting point to a first end point; the second arc-shaped belt 20 is a continuous arc-shaped belt from a second starting point to a second end point;

[0107] The distance between the first starting point and the second starting point is 10 mm;

[0108] The distance between the first end point and the second end point is 10 mm.

[0109] Compared with Example 1, the surgical artificial heart valve provided in this embodiment can further effectively prevent the muscle tissue in the ventricle from interfering with the normal operation of the surgical artificial heart valve through the arrangement of the first arc-shaped band 10 and the second arc-shaped band 20. The arc-shaped bands arranged on both sides of the long axis direction of the surgical artificial heart valve form channels on the outflow side, which can effectively optimize hemodynamics and reduce the formation of blood clots.

[0110] Furthermore, by making the materials of the first arc-shaped band 10 and the second arc-shaped band 20 independently of each other as polymer materials, the extension rate of scar tissue can be effectively reduced, endothelialization of the first leaflet and the second leaflet can be prevented, and the durability of the surgical artificial heart valve can be improved.

[0111] Example 3

[0112] This embodiment provides a surgical artificial heart valve, such as Figure 6 As shown, the difference from Example 1 is that in this embodiment, a first arc-shaped belt 10 made of PET is provided on the side of the first support seat away from the second support seat, and a second arc-shaped belt 20 made of PET is provided on the side of the second support seat away from the first support seat;

[0113] The first arc-shaped belt 10 includes a first starting point and a first end point;

[0114] In the second arc-shaped belt 20, the endpoint closest to the first starting point is the second starting point, and the endpoint closest to the second ending point is the second ending point;

[0115] The first arcuate belt 10 is an interval arcuate belt from a first starting point to a first end point; the second arcuate belt 20 is an interval arcuate belt from a second starting point to a second end point;

[0116] The distance between the first starting point and the second starting point is 10 mm;

[0117] The distance between the first end point and the second end point is 10 mm.

[0118] Compared with Example 1, the surgical artificial heart valve provided in this embodiment can further effectively prevent the muscle tissue in the ventricle from interfering with the normal operation of the surgical artificial heart valve through the arrangement of the first arc-shaped band 10 and the second arc-shaped band 20. The arc-shaped bands arranged on both sides of the long axis direction of the surgical artificial heart valve form channels on the outflow side, which can effectively optimize hemodynamics and reduce the formation of blood clots.

[0119] Furthermore, by making the materials of the first arc-shaped band 10 and the second arc-shaped band 20 independently of each other as polymer materials, the extension rate of scar tissue can be effectively reduced, endothelialization of the first leaflet and the second leaflet can be prevented, and the durability of the surgical artificial heart valve can be improved.

[0120] Example 4

[0121] This embodiment provides a surgical artificial heart valve, which is different from Embodiment 1 in that the first support seat and the second support seat are connected by a snap connection, and the snap includes a spring elastic part.

[0122] The native mitral valve ring is saddle-shaped, and in three-dimensional space, the anterior and posterior leaflets are higher than the junction. During the contraction and relaxation of the heart, the mitral valve ring also moves, and the junction of the inner and outer anterior and posterior leaflets will fold down along the anterior-posterior radial direction of the mitral valve. The present invention can enable the surgical artificial heart valve to still have the conditions for movement after implantation through the provision of the elastic part, and retain the ability of muscle tissue to contract and relax to the greatest extent.

[0123] To summarize, the present invention makes the distance between one of the three flap feet of the first valve and one of the three flap feet of the second valve close, while the distance between the other two flap feet of the first valve and the other two flap feet of the second valve exceeds the inner diameter of the first support seat or the second support seat, so that when the flap feet interfere with the muscle tissue, the two flap feet can form a surface from both sides of the long axis direction to block the myocardial tissue from squeezing the outflow side opening of the valve, thereby ensuring the effective opening area of ​​the valve.

[0124] The above description is only a specific implementation mode of the present invention, but the protection scope of the present invention is not limited thereto. Those skilled in the art should understand that any changes or substitutions that can be easily thought of by those skilled in the art within the technical scope disclosed by the present invention are within the protection scope and disclosure scope of the present invention.

Claims

1. A surgical artificial heart valve, characterized in that: The surgical artificial heart valve comprises a first valve and a second valve which are sequentially connected along the long axis direction; The first valve comprises a first support seat, three first valve petal feet arranged on the outflow side of the first support seat, and a first leaflet attached to the three first valve petal feet; the three first valve petal feet are evenly distributed on the outflow side of the first support seat; The second valve comprises a second support seat, three second valve petal feet arranged on the outflow side of the second support seat, and a second leaflet attached to the three second valve petal feet; the three second valve petal feet are evenly distributed on the outflow side of the second support seat; Among the three first valve petals and the three second valve petals, the distance between the closest first valve petal and the second valve petal is a, and a≤3mm; among the other two first valve petals and the other two second valve petals, the distance between any first valve petal and its closest second valve petal is b1 mm, and the distance between the other first valve petal and its closest second valve petal is b2 mm, and the inner diameter of the first support seat is d1 mm, and the inner diameter of the second support seat is d2 mm, then d1 <b1<2d1,d2<b2<2d2; A first arc-shaped belt is disposed on a side of the first support base away from the second support base; and / or a second arc-shaped belt is disposed on a side of the second support base away from the first support base.

2. The surgical prosthetic heart valve according to claim 1, characterized in that The value of d1 is 15-25; The value of d2 is 15-25.

3. The surgical prosthetic heart valve according to claim 1, characterized in that: The b1 and b2 satisfy the following relationship: b1=b2.

4. The surgical prosthetic heart valve according to claim 1, characterized in that: The first support seat of the first valve is connected to the second support seat of the second valve.

5. The surgical prosthetic heart valve according to claim 4, characterized in that: The connection method between the first support base and the second support base includes any one of welding, riveting or snap connection, or a combination of at least two of them.

6. The surgical prosthetic heart valve according to claim 1, characterized in that: The first arc-shaped belt includes a first starting point and a first end point; In the second arc-shaped band, the endpoint closest to the first starting point is the second starting point, and the endpoint closest to the second ending point is the second ending point; The distance between the first starting point and the second starting point is c1 mm, and c1 satisfies: 20≤c1≤40; The distance between the first end point and the second end point is c2 mm, and c2 satisfies: 20≤c2≤40.

7. The surgical prosthetic heart valve according to claim 6, characterized in that The distance between the first starting point and the second starting point is c1 mm, then c1<1.5d1; The distance between the first end point and the second end point is c2 mm, then c2<1.5d2.

8. The surgical artificial heart valve according to claim 6 or 7, characterized in that: The c1 and c2 satisfy the following relationship: c1=c2.

9. The surgical prosthetic heart valve according to claim 1, characterized in that: The edges of the unsutured portions of the first leaflets are sequentially abutted and joined together to form a first valve structure, wherein a small hole is formed in the center of the first valve structure, and the convex surface of each first leaflet faces the same side; The edges of the unsutured parts of the second leaflets are sequentially butted together to form a second valve structure. The second valve structure forms a small hole in the center of the second valve, and the convex surface of each second leaflet faces the same side.

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