Valve stent and heart valve

Abstract

The present invention relates to a valve stent, which includes a leaflet stent and a skirt stent, wherein the leaflet stent has a first end and a second end opposite to the first end, the skirt stent extends radially outward from the leaflet stent, the skirt stent is arranged close to the first end of the leaflet stent, the valve stent also includes a barb arranged on the leaflet stent and close to the second end, the barb extends radially outward from the leaflet stent and toward the first end, and the axial distance between one end of the barb close to the leaflet stent and one end of the skirt stent close to the leaflet stent is in the range of 10 mm to 20 mm. The above-mentioned valve stent can effectively prevent displacement. The present invention also relates to a heart valve.

Description

Technical Field

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

[0002] Heart valve disease is a very common heart disease, among which valve damage caused by rheumatic fever is one of the most common causes. With the aging of the population, senile valvular disease and valvular lesions caused by myocardial infarction due to coronary heart disease are becoming more and more common. These valvular lesions not only endanger life safety and affect the quality of life, but also bring heavy burdens and pressures to families and society. The human heart is divided into four heart chambers: the left atrium, the left ventricle, the right atrium, and the right ventricle. The two atria are connected to the two ventricles respectively, and the two ventricles are connected to the two aortas. The heart valve grows between the atria and ventricles, and between the ventricles and aortas, acting as a one-way valve to help blood flow in one direction. The four valves of the human body are called the mitral valve, tricuspid valve, aortic valve and pulmonary valve. If these valves are diseased, it will affect the movement of blood flow, thereby causing abnormal heart function and eventually leading to heart failure.

[0003] In recent years, patients with mitral stenosis and regurgitation can also undergo percutaneous transcatheter mitral valve replacement, which is an interventional, minimally invasive method to implant a heart valve for this operation, allowing patients to avoid the pain of open-chest surgery. However, due to the short history of this technology, it still faces many problems. For example, existing heart valves are prone to displacement under blood pressure after implantation. Summary of the invention

[0004] Based on this, in order to address the above problems, it is necessary to provide a valve stent and a heart valve to reduce the probability of displacement of the heart valve after implantation.

[0005] A valve stent comprises a leaflet stent and a skirt stent, the leaflet stent having a first end and a second end opposite to the first end, the skirt stent extending radially outward from the leaflet stent, the skirt stent being arranged close to the first end of the leaflet stent, the valve stent further comprising a barb arranged on the leaflet stent and close to the second end, the barb extending radially outward from the leaflet stent and toward the first end, the axial distance between one end of the barb close to the leaflet stent and one end of the skirt stent close to the leaflet stent is in the range of 10 mm to 20 mm.

[0006] In one embodiment, the length of the barb ranges from 2 mm to 3 mm, or from 3 mm to 5 mm, or from 5 mm to 10 mm.

[0007] In one embodiment, the angle between the barb and the leaflet support ranges from 20° to 45°, or from 45° to 60°, or from 60° to 70°.

[0008] In one embodiment, the ratio of the width to the thickness of the barb is in the range of 0.75 to 1, or 1 to 1.2, or 1.2 to 1.5.

[0009] In one embodiment, the barb includes a fixing portion and a bending portion, one end of the fixing portion is connected to the leaflet support, and the other end is connected to the bending portion, the bending portion is bent toward the longitudinal center axis of the leaflet support, and the angle between the bending portion and the fixing portion ranges from 110° to 160°.

[0010] In one of the embodiments, a fillet is provided at the position where the leaflet support is connected to the barb, and the radius of the fillet is in the range of 0.02 mm to 0.30 mm.

[0011] In one embodiment, the distance between one end of the skirt support close to the leaflet support and the first end is 1 / 4 to 1 / 2 of the axial length of the leaflet support.

[0012] In one embodiment, the leaflet stent includes a plurality of wave coils arranged at intervals along the axial direction of the leaflet stent and a plurality of connecting rods connecting the plurality of wave coils, the connecting rods extend along the axial direction of the leaflet stent, and the barbs are arranged on the connecting rods.

[0013] In one embodiment, the valve support further includes a connecting rod and a connector, one end of the connecting rod is connected to the second end, and one end of the connecting rod away from the second end is connected to the connector.

[0014] In one embodiment, the valve stent further comprises a tether connected to the connector.

[0015] An artificial heart valve comprises any of the valve stents described above, and also comprises a baffle and a leaflet, wherein the baffle covers the leaflet stent and the skirt stent, and the leaflet is located inside the leaflet stent and fixedly connected to the leaflet stent and / or the baffle.

[0016] The above-mentioned valve stent and heart valve, when the heart valve is implanted in the human heart, the body's own mitral valve leaflets will be squeezed against the ventricular wall by the leaflet stent and remain in an open state, the skirt stent of the heart valve can be stuck on the mitral valve ring to prevent the heart valve from falling into the left ventricle, and the barbs arranged at the second end of the leaflet stent can hook the lower edge of the body's own leaflets, and under the tension of the valve chordae tendineae, the axial freedom of the heart valve can be restrained to prevent the heart valve from moving toward the left atrium, effectively reducing the probability of displacement of the heart valve after implantation, and because the barbs can be hung on the body's mitral valve leaflets without piercing into the ventricular tissue, it can prevent the barbs from rubbing against the ventricular tissue and damaging the myocardial tissue around the ventricle, thereby avoiding the risk of puncturing the ventricular wall. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 is a schematic structural diagram of a heart valve according to an embodiment;

[0018] Figure 2 for Figure 1 The schematic diagram of the heart valve after implantation into the heart is shown;

[0019] Figure 3 for Figure 2 The schematic diagram of the local structure of the heart valve shown is another perspective after it is implanted into the heart;

[0020] Figure 4 for Figure 1 A schematic diagram of the local structure of a heart valve from another perspective is shown;

[0021] Figure 5 for Figure 1 A schematic diagram of a partial structure of a valve stent of a heart valve shown;

[0022] Figure 6 for Figure 5 A schematic diagram of a local structure of a valve stent during processing is shown;

[0023] Figure 7 for Figure 5 A schematic diagram of a local structure of the valve stent shown in another perspective;

[0024] Figure 8 A schematic diagram of a partial structure of a valve stent according to another embodiment;

[0025] Fig. 9 A schematic diagram of a partial structure of a valve stent according to another embodiment;

[0026] Fig.10 A schematic diagram of a partial structure of a valve stent according to another embodiment;

[0027] Fig.11 for Figure 5A schematic structural diagram of the elastic member shown;

[0028] Fig.12 is a partial cross-sectional view of a heart valve connected to a hollow steel cable according to an embodiment;

[0029] Fig.13 for Fig.12 A schematic structural diagram of an angle of a heart valve connector is shown. DETAILED DESCRIPTION

[0030] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, the specific embodiments of the present invention are described in detail below in conjunction with the accompanying drawings. In the following description, many specific details are set forth to facilitate a full understanding of the present invention. However, the present invention can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without violating the connotation of the present invention, so the present invention is not limited by the specific implementation disclosed below.

[0031] It should be noted that when an element is referred to as being "fixed to" or "disposed on" another element, it may be directly on the other element or there may be a central element. When an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be a central element at the same time. The terms "vertical", "horizontal", "left", "right" and similar expressions used herein are for illustrative purposes only and do not represent the only implementation method.

[0032] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art to which the present invention belongs. The terms used herein in the specification of the present invention are only for the purpose of describing specific embodiments and are not intended to limit the present invention. The term "and / or" used herein includes any and all combinations of one or more of the related listed items.

[0033] See also Figure 1 and Figure 2 In this embodiment, the structure of the heart valve 10 is described by taking the mitral valve stent as an example. Of course, in other embodiments, the heart valve 10 is not limited to Figure 1 The mitral valve stent shown can also be other types of artificial valve stents, such as a pulmonary valve stent, an aortic valve stent, etc.

[0034] Please continue reading Figure 1 The heart valve 10 includes a valve stent 100, a baffle 200 and a valve leaf 300. The baffle 200 covers the valve stent 100. The valve leaf 300 is located in the valve stent 100 and is fixedly connected to the valve stent 100 and / or the baffle 200.

[0035] Please also read Figure 4 and Figure 5 The valve stent 100 includes a leaflet stent 110 , a skirt stent 120 , a connecting rod 130 , a connector 140 and a tether 150 . The skirt stent 120 and the connecting rod 130 are respectively connected to the leaflet stent 110 , the connecting member 140 is connected to the connecting rod 130 , and the tether 150 is connected to the connecting member 140 .

[0036] The leaflet support 110 is roughly cylindrical, having a first end and a second end arranged opposite to the first end. In the present application, the first end is the inflow end and the second end is the outflow end. The skirt support 120 extends radially outward from the leaflet support 110 along the leaflet support 110, and the skirt support 120 is arranged near the first end of the leaflet support 110. The valve support 100 also includes a barb 111 arranged on the leaflet support 110 and near the second end, and the barb 111 extends radially outward from the leaflet support 110 and extends toward the first end. The axial distance between one end of the barb 111 close to the leaflet support 110 and one end of the skirt support 120 close to the leaflet support 110 ranges from 10mm to 20mm. In one embodiment, the axial distance between one end of the barb 111 close to the leaflet support 110 and one end of the skirt support 120 close to the leaflet support 110 ranges from 10mm to 16mm. Specifically, the barb 111 is located at the second end of the leaflet support 110.

[0037] Please also read Figure 2 and Figure 3 When the heart valve is implanted in the human heart 20, the body's own mitral valve leaflets 21 will be squeezed against the ventricular wall by the leaflet support 110 and remain in an open state. The skirt support 120 of the heart valve 10 can be stuck on the mitral valve ring 22 to prevent the heart valve 10 from falling into the left ventricle. The barbs 111 arranged at the second end of the leaflet support 110 can hook the lower edge of the body's own leaflets, and under the tension of the valve chordae tendineae 23, the axial freedom of the heart valve 10 can be restrained to prevent the heart valve 10 from moving toward the left atrium, effectively reducing the probability of displacement of the heart valve after implantation. Moreover, since the barbs 111 can be hung on the body's mitral valve leaflets 21 without piercing into the ventricular tissue, the barbs can be prevented from rubbing against the ventricular tissue to damage the myocardial tissue around the ventricle, thereby avoiding the risk of puncturing the ventricular wall.

[0038] Specifically, the leaflet stent 110 includes a plurality of corrugations 112 arranged at intervals along the axial direction of the leaflet stent 110 and a plurality of connecting rods 113 connecting the plurality of corrugations 112. The connecting rods 113 extend along the axial direction of the leaflet stent 110. Each connecting rod 113 is fixedly connected to all the corrugations 112. The barbs 111 are arranged on the connecting rods 113. Since the connecting rods 113 pass through the first end and the second end of the leaflet stent 110 and have a relatively high rigidity, when the barbs 111 are subjected to force, the connecting rods 113 can withstand the force transmitted from the root of the barbs 111, and the leaflet stent 110 will not be locally deformed due to the torque generated on the barbs.

[0039] In the illustrated embodiment, the leaflet support 110 includes three corrugations 112, and the three corrugations 112 are connected and fixed by a plurality of connecting rods 113. The number of connecting rods 113 is the same as the number of troughs of the corrugations 112, and one connecting rod 113 is simultaneously fixedly connected to the troughs of the three corrugations 112. Of course, in other embodiments, the connecting rod 113 may also be fixedly connected to other positions of the corrugations 112, such as positions between crests and troughs.

[0040] Barb 111 is cut. Please also refer to Figure 6 , the cutting pattern of the barb 111 is located on the end of the connecting rod 113 of the leaflet stent 110 away from the first end, and the barb 111 is bent out during shaping. A fillet 114 is provided at the position where the connecting rod 113 of the leaflet stent 110 is connected to the barb 111, and the radius of the fillet 114 ranges from 0.02mm to 0.30mm. This can avoid excessive deformation of the root of the barb 111 due to stress concentration caused by the load on the barb 111 during processing or after implantation, thereby reducing the risk of the barb 111 breaking. In one embodiment, the radius of the fillet 114 is 0.03mm to 0.10mm, which can meet the fatigue resistance and strength properties of the barb 111, and can reduce the risk of the barb 111 breaking during processing and after implantation. Specifically, the number of barbs 111 is 6 to 18, and they are evenly distributed in the circumferential direction of the leaflet stent 110. In this embodiment, the number of the barbs 111 is 9, and the ends of the barbs 111 connected to the leaflet support 110 are located at the same height of the leaflet support 110 .

[0041] In the illustrated embodiment, there are two rounded corners 114, which are located on both sides of the barb 111. It should be noted that in one embodiment, there may be only one rounded corner 114.

[0042] See also Figure 7, the length a of the barb 111 is 2mm~3mm, or 3mm~5mm, or 5mm~10mm. In the present application, the length a of the barb 111 refers to the length of the line between the end point of the barb 111 connected to the leaflet stent 110 and the end point of the barb 111 away from the leaflet stent 110. Preferably, the length a of the barb 111 is 3mm~5mm, so that the barb 111 will not easily loosen after hooking the body's own leaflets, and will not cause the barb 111 to pierce the tissue to cause perforation or damage the blood vessel. The angle A between the barb 111 and the leaflet stent 110 is 20°~45°, or 45°~60°, or 60°~70°. Preferably, the angle A between the barb 111 and the leaflet stent 110 is 45°~60°, which can make it easier for the barb 111 to hook the body's own leaflets without significantly affecting the sheath force. The width of the barb 111 is 0.2mm~1.0mm. Preferably, the width b of the barb 111 is 0.3mm~0.5mm, which may not affect the sheathing force of the heart valve and can also provide effective axial support force. In the present embodiment, the barb 111 is designed to be of equal width (the end is not considered), and the width of the barb 111 in the present application is the width excluding the position outside the end. The thickness c of the barb 111 is the same as the overall thickness of the leaflet stent 110, which is 0.2mm~0.6mm. Preferably, the thickness c is 0.3mm~0.5mm, which can ensure the strength of the barb 111 and can also provide a larger axial support force. The ratio of the width b to the thickness c of the barb 111 is in the range of 0.75~1, or 1~1.2, or 1.2~1.5, which can make the strain of the barb 111 when bearing the blood pressure load smaller, thereby improving the strength and fatigue resistance of the barb 111. Preferably, the ratio of the width b to the thickness c of the barb 111 is in the range of 1 to 1.2, and the strength and fatigue resistance of the barb 111 are better.

[0043] In order to prevent the barb 111 from abrading the surrounding tissue, the end of the barb 111 may be blunted. Figure 8 , the end of the barb 111 can be spheroidized by argon arc welding. Fig. 9 , after the end of the barb 111 is formed, the barb 111 is chamfered or cut with a chamfered pattern. Fig.10The barb 111 includes a fixing portion 111a and a bending portion 111b. One end of the fixing portion 111a is connected to the leaflet stent 110, and the other end is connected to the bending portion 111b. The bending portion 111b is bent toward the longitudinal center axis of the leaflet stent 110, and the angle between the bending portion 111b and the fixing portion 111a is in the range of 110° to 160°. By bending the end of the barb 111 away from the leaflet stent 110, the end of the barb 111 will not directly contact the ventricular wall at a large angle, which can greatly reduce the friction resistance with the ventricular wall or the possibility of the ventricular wall. In addition, the probability of the barb catching the sheath and scratching the sheath during release or recovery can be greatly reduced. More specifically, the length of the bending portion 111b is 0.2 to 0.5 times the total length of the barb 111. During processing, the bending portion 111b can be formed by bending toward the inner side of the leaflet stent 110 during heat setting.

[0044] The distance between the end of the skirt support 120 close to the leaflet support 110 and the first end is 1 / 4 to 1 / 2 of the axial length of the leaflet support 110. Figure 4 and Figure 5 The skirt support 120 includes a support portion 121 and a raised portion 122. The support portion 121 extends radially outward from the leaflet support 110 along the leaflet support 110, and the raised portion 122 extends from one end of the support portion 121 away from the leaflet support 110 to the first end of the leaflet support 110. The support portion 121 is used to fix the heart valve 10 to the human mitral valve annulus 22 of the heart 20, and the raised portion 122 is used to prevent the edge of the support portion 121 away from the leaflet support 110 (i.e., the distal edge) from eroding the left atrial tissue. If there is no raised portion 122, the distal edge of the radial support portion 121 directly contacts the atrial tissue. Under long-term heart beating, the distal edge of the support portion 121 will form a cutting effect on the atrial tissue, causing damage to the atrial tissue. By providing the raised portion 122, the line contact between the skirt support 120 and the atrial tissue is changed into surface contact, thereby increasing the contact area, reducing the contact pressure, and avoiding the cutting effect of the skirt support 120 on the heart tissue and the resulting abrasion.

[0045] exist Figure 4 In the illustrated embodiment, the support portion 121 of the skirt support 120 is fixedly connected to the trough of the wave ring 112 near the first end of the leaflet support 110. In this way, when the heart valve 10 is implanted in the heart 20, nearly one-third of the axial dimension of the leaflet support 110 can be located in the left atrium, thereby preventing the leaflet support 110 from being implanted too much in the left ventricle and causing stenosis or even obstruction of the left ventricular outflow tract.

[0046] The width of the support portion 121 of the skirt support 120 is 2 mm to 6 mm, so as to fully ensure the fixation of the heart valve 10 at the mitral valve annulus 22 of the human heart. Here, the width of the support portion 121 refers to the distance between the end of the support portion 121 close to the tilted portion 122 and the leaflet support 110. In this embodiment, the width of the support portion 121 is 4 mm. The height of the tilted portion 122 is 2 mm to 6 mm. Here, the height of the tilted portion 122 refers to the distance between the end of the tilted portion 122 away from the support portion 121 and the end close to the support portion 121. If the height of the tilted portion 122 is less than 2 mm, it cannot prevent the edge of the skirt support 120 from wearing the heart tissue. If the height is greater than 6 mm, it will damage other tissues of the left atrium. In this embodiment, the height of the tilted portion 122 is 4 mm.

[0047] In this embodiment, the outer contour of the support portion 121 of the skirt support 120 is circular when viewed from the valve blood flow inflow side. Of course, in other embodiments, the outer contour of the support portion 121 can also be other shapes, such as D-shaped or quasi-D-shaped.

[0048] See also Figure 4 The valve support 10 further includes an elastic member 160 disposed between the second end of the leaflet support 110 and the skirt support 120, and the elastic member 160 protrudes radially outward from the leaflet support 110. Specifically, the elastic member 160 includes a plurality of elastic threads disposed around the periphery of the leaflet support 110, and the elastic threads extend radially outward from the leaflet support 110 along the leaflet support 110, and one end of the elastic thread is connected to the leaflet support 110, and the other end is connected to the skirt support 120. Please refer to Fig.11 , multiple elastic wires are connected to each other to form a circle of wave-shaped rings, the wave-shaped rings include multiple distal vertices 161, multiple proximal vertices 163 and support bodies 162 connecting adjacent distal vertices 161 and proximal vertices 163, multiple distal vertices 161 are respectively connected to the skirt support 120, and multiple proximal vertices 163 are respectively connected to the leaflet support 110, which can reduce the number of connection points between the elastic member 160 and the leaflet support 110 and the skirt support 120, and improve the connection strength between the elastic member 160 and the leaflet support 110 and the skirt support 120. In the illustrated embodiment, multiple distal vertices 1181 are respectively fixedly connected to one end of the first support portion 1141 away from the leaflet support 110. Multiple proximal vertices 163 are located on the same circumferential surface perpendicular to the longitudinal central axis of the leaflet support 110, that is, the connection points of multiple proximal vertices 163 and the leaflet support 110 have no height difference in the axial direction of the leaflet support 110. Each proximal apex 163 is fixed at a trough of the leaflet support 110 .

[0049] It should be noted that the elastic member 160 is not necessarily limited to an elastic wire. The elastic member 160 may also be a structure that can be deformed under a certain force. For example, the two ends are respectively fixed to the elastic coating of the leaflet support 110 and the skirt support 120; for another example, an annular elastic sponge is arranged between the leaflet support 110 and the skirt support 120. The inner diameter of the sponge is equal to the outer diameter of the leaflet support 110, and the outer diameter of the sponge is equal to the outer diameter of the support portion 121 of the skirt support 120. The sponge is fixed to the leaflet support 110 and the support portion 121 by suturing, or is fixed to the baffle 200 by suturing.

[0050] Of course, in other embodiments, the distal vertex 161 may not be connected to any position of the skirt support 120, and only the proximal vertex 163 is connected to the leaflet support 110. In other embodiments, the distal vertex 161 may also be connected to other positions of the skirt support 120, and the proximal vertex 163 may also be connected to different axial positions of the leaflet support 110. The positions of each distal vertex and proximal vertex in the leaflet support 110 and the skirt support 120 may be adjusted according to specific circumstances.

[0051] It is understandable that in other embodiments, the multiple elastic threads may not be connected. For example, the periphery of the leaflet support 110 is provided with multiple elastic threads parallel to each other, one end of each elastic thread is connected to the leaflet support 110 , and the other end is connected to the skirt support 120 .

[0052] In order to facilitate the installation of the heart valve 10 into the sheath tube, for example, the length of each elastic thread is approximately equal to the sum of the distance from the end of the skirt support 120 fixed with the elastic thread to the leaflet support 110 and the axial distance from the position where the leaflet support 110 and the elastic thread are fixed to the end of the skirt support 120 close to the leaflet support 110, ignoring the length of the two ends of the elastic thread in the circumferential direction after the installation into the sheath tube, after the heart valve 10 is compressed into the sheath tube, the length of each elastic thread is equal to the distance from the position where the skirt support and the elastic thread are fixed to the position where the leaflet support 110 and the elastic thread are fixed. Specifically in this embodiment, the length of the support body 162 is approximately equal to the sum of the distance from the distal vertex 161 connected to the support body 162 to the leaflet support 110 and the axial distance from the proximal vertex 163 connected to the support body 162 to the end of the skirt support 120 close to the leaflet support 110, which can avoid folding of the support body 162 after the support body 162 is installed into the sheath tube, making it convenient for the heart valve 10 to be installed into the sheath tube.

[0053] In this embodiment, the elastic wire is a nickel-titanium wire with a wire diameter of 0.002-0.006 inches, which has good deformability and can fully fill the gap between the mitral valve annulus and the heart valve tissue, thereby effectively preventing paravalvular leakage.

[0054] Please refer again Figure 5 and Fig.12The connecting rod 130 includes a proximal connecting rod 132, a leaflet support connecting rod 134 and a joint 136. The proximal connecting rod 132 is roughly rod-shaped. The leaflet support connecting rod 134 is roughly V-shaped, including two struts extending from one end of the proximal connecting rod 132 to the leaflet support 110, and the ends of the two struts away from the proximal connecting rod 132 are respectively fixed to two troughs adjacent to the wave ring near the second end of the leaflet support 110, and each trough is connected to a strut, so that multiple connecting rods 130 are evenly distributed along the second end, so as to play a guiding role when the heart valve 10 is received into the sheath tube, and prevent the trough from being stuck outside the sheath tube. If the leaflet support connecting rod 134 is connected to the crest of the wave ring near the second end of the leaflet support 110, when the heart valve 10 is sheathed, the trough will be stuck outside the sheath tube.

[0055] It is understandable that the leaflet stent link 134 can also be other shapes, for example, it can be a straight line shape, extending directly from one end of the proximal link 132 to connect with the trough of the second end of the leaflet stent, that is, the number of struts is consistent with the number of proximal links 132.

[0056] In the illustrated embodiment, the leaflet support 110, the skirt support 120 and the connecting rod 130 are cut from the same pipe and are an integrally formed structure. Compared with the separate cutting and then assembling, the integral cutting has the advantages of small radial size after compression and easy sheathing. At the same time, there is no welding or splicing structure between the integrally formed parts, thereby improving the fatigue resistance of the valve support 100. In this embodiment, the valve support 100 can be cut and shaped by a superelastic nickel-titanium metal pipe with a diameter of 6mm~10mm and a wall thickness of 0.3mm~0.5mm.

[0057] Please also see Figure 1 , Figure 5 , Fig.12 and Fig.13, the joint 136 of the connecting rod 130 is connected to the connecting member 140. The connecting member 140 includes a socket 142 and a connecting cover 144. In the illustrated embodiment, the socket 142 is roughly cylindrical, one end is recessed to form a receiving groove 1422, and the other end is provided with a screw hole 1424. The screw hole 1424 is connected to the receiving groove 1422. In the illustrated embodiment, the end of the socket 142 provided with the screw hole 1424 gradually shrinks to a frustum shape to reduce the impact on the heart tissue or the sheath. In one embodiment, the heart valve 10 also includes a hollow steel cable 30 for assisting the delivery of the heart valve 10. The screw hole 1424 can be connected to the hollow steel cable 30 for delivering the heart valve 10, and one end of the hollow steel cable 30 can be screwed with the screw hole 1324, so that one end of the hollow steel cable 30 is fixed to the connecting member 130, and the connection can be released by rotation. When the heart valve 10 is delivered in the delivery sheath, the hollow steel cable 30 can push and pull the heart valve 10, allowing the heart valve 10 to move in the inner cavity of the delivery sheath, and when the heart valve 10 is released from the delivery sheath, the heart valve 10 can be pulled back into the delivery sheath again through the hollow steel cable 30.

[0058] The connection cover 144 is disposed and fixed to the receiving groove 1422. In the illustrated embodiment, the connection cover 144 is received in the receiving groove 1422 and fixed to the groove wall of the receiving groove 1422 by welding. The connection cover 144 is provided with a plurality of limiting holes 1442. The connecting rod 130 is passed through the limiting holes 1442, and the joint 136 is received in the receiving groove 1422. The joint 136 abuts against a side surface of the connection cover 144 close to the screw hole 1424. In the illustrated embodiment, the size of the joint 136 in at least one dimension is larger than the aperture of the limiting hole 1442 to prevent the joint 136 from falling out of the limiting hole 1442.

[0059] A blocking portion 152 is formed at one end of the tether 150, and the tether 150 is fixed to the connector 140 through the blocking portion 152. The tether 150 is inserted into the screw hole 1424 and the blocking portion 152 is received in the receiving groove 1422. The size of the blocking portion 152 in one dimension is larger than the inner diameter of the screw hole 1424, so as to prevent the blocking portion 152 from falling off from the screw hole 1424. The material of the tether 150 is selected from at least one of polyester, nylon, ultra-high molecular weight polyethylene, nickel titanium and stainless steel braided wire. In the illustrated embodiment, the blocking portion 152 is a knot formed by tying one end of the tether 150. Of course, in other embodiments, it can also be other structures formed at one end of the tether 150, as long as the tether 150 can be prevented from falling off from the screw hole 1324. When in use, the tether 150 extends outward from the receiving groove 1422 and passes through the inner hole of the hollow steel cable 30.

[0060] It should be noted that, in one embodiment, the heart valve 10 may also be provided without the tether 150 as required. For example, after a traction test is performed to determine that the barbs 111 completely fix the heart valve 10, the tether 150 may be removed.

[0061] Please refer again Figure 2 The heart valve 10 may further include a gasket 170. The material of the gasket 170 is selected from at least one of silicone, polyester, nylon, ultra-high molecular weight polyethylene, nickel titanium and stainless steel braided wire. The gasket 170 may be a felt-like disc, a disc-shaped structure braided with titanium nickel wire, or a disc-shaped structure molded with a polymer material. When the heart valve 10 is implanted in the human heart 20, the end of the tether 150 away from the connecting rod 130 passes through the heart 20 and the gasket 170, and is then tied and fixed to the gasket 170.

[0062] Please continue reading Figure 4 The baffle 200 covers the surface of the leaflet support 110. The baffle 200 is used to block the blood flow from overflowing through the leaflet support 110, and cooperates with the leaflet 300 to ensure the unidirectional flow of blood in the heart valve 10. The material of the baffle 200 is PTFE cloth or film, PET cloth or film, PU cloth or film, PA cloth or film, sausage casing or animal heart. Depending on the material, the baffle 200 can be laminated by a hot pressing process, or fixed to the leaflet support 110 by suturing. In this embodiment, please refer to Figure 1 and Figure 2 , the baffle 200 wraps the inner and outer surfaces of the leaflet support 110 and the skirt support 120, and covers the elastic member 160. By covering the surface of the skirt support 120 with the baffle 200, the contact area between the skirt support 120 and the heart tissue can be increased, the contact pressure can be reduced, and the crawling of the heart endothelial tissue on the surface of the heart valve 10 can be accelerated, thereby reducing the thrombogenicity of the heart valve 10. In one of the embodiments, in order to accelerate the crawling of the endothelial tissue on the surface of the heart valve 10, a parylene layer can be deposited on the non-biological tissue surface of the heart valve 10. In one of the embodiments, a parylene layer can be formed on the surface of the baffle 200. The thickness of the parylene layer is 1 micron to 5 microns. Preferably, the material of the parylene layer is C-type parylene.

[0063] In one of the embodiments, a hydrogel layer (not shown) may also be provided between the baffle 200 and the leaflet support 110. The material of the hydrogel layer is selected from at least one of polyvinyl alcohol and polyurethane. In one of the embodiments, the hydrogel layer is laminated on the surface of one side of the baffle 200 close to the leaflet support 110 by coating. Of course, in other embodiments, the hydrogel layer may also be fixed between the baffle 200 and the leaflet support 110 by suturing. When the heart valve 10 is implanted in the human heart 20, the hydrogel swells when exposed to water, and the position corresponding to the baffle 200 bulges out. If there is a gap between the heart valve 10 and the mitral valve tissue after the heart valve 10 is implanted in the human heart 20, the expanded hydrogel layer causes the baffle 200 to bulge outward, thereby blocking the gap and reducing the risk of paravalvular leakage.

[0064] Please continue reading Figure 4 , the contour of one end of the baffle 200 close to the second end of the leaflet support 110 is the same as the contour of the second end of the leaflet support 110. In the illustrated embodiment, the corrugation 112 is located at one end of the leaflet support close to the connecting rod 130 and is fixed to the connecting rod 130. The contour of the second end of the leaflet support 110, that is, the contour of the corrugation 112, is sawtooth-shaped. The contour of one end of the baffle 200 close to the second end of the leaflet support 110 is sawtooth-shaped and is the same as the contour of the second end of the leaflet support 110. This can not only prevent the baffle 200 from protruding and getting stuck outside the sheath when the heart valve 10 is radially compressed into the sheath, but also prevent the left ventricular outflow tract stenosis caused by too many baffles 200 in the left ventricle. The end of the baffle 200 close to the second end of the leaflet support 110 is sutured and fixed to the corrugation 112 by sutures. Preferably, the baffle 200 is sewn to the inner side of the wave ring 112 to prevent the baffle 200 from protruding when the heart valve 10 is put into the sheath tube, thereby preventing the baffle 200 from being stuck outside the sheath tube.

[0065] Of course, in other embodiments, the second end of the leaflet stent 110 is not serrated. In this case, the shape of the end of the baffle 200 close to the second end of the leaflet stent 110 can be changed accordingly. As long as the contours of the two are the same and the baffle 200 is sewn to the inner side of the wave ring 112, the baffle 200 can be prevented from protruding when it is received into the sheath.

[0066] Please refer again Figure 4 , the leaflets 300 are located inside the leaflet support 110 and fixed to the baffle 200 on the surface of the leaflet support 110. The leaflets 300 are cut from animal pericardium. In the illustrated embodiment, the leaflets 300 are roughly fan-shaped, with a total of three leaves, which are arranged in sequence along the circumference of the leaflet support 110. The ends of the inner surface of the two adjacent leaflets 300 close to the leaflet support 110 are combined together to form a leaflet angle, and the periphery of the leaflet 300 is fixed to the leaflet support 110 and the baffle 200 by suturing, and the leaflet angle is fixed to the connection between the connecting rod 130 and the leaflet support 110.

[0067] Please also read Figure 2 and Figure 3 When the heart valve 10 is implanted in the human heart 20, the mitral valve leaflets 21 of the human body will be squeezed against the ventricular wall by the leaflet support 110 and remain in an open state. The skirt support 120 of the heart valve 10 fixes the heart valve 10 on the mitral valve ring 22 to prevent the heart valve 10 from falling into the left ventricle. The end of the tether 150 away from the connecting rod 130 passes through the heart 20 and the gasket 170 and is fixed to prevent the heart valve 10 from moving toward the left atrium. The barb 111 arranged at the second end of the leaflet support 110 can hook the human body. The lower edge of the valve leaflet itself can restrain the axial freedom of the valve stent 100 under the tension of the valve chordae 23, preventing the valve stent 100 from moving toward the left atrium, effectively reducing the probability of displacement of the heart valve 10 after implantation. In addition, the elastic member 160 is located at the position of the mitral valve ring 22, and the elastic member will be concave or convex in the radial direction and / or toward the first end to adapt to the shape of the mitral valve ring 22, keeping its outer surface in contact with the contact surface of the mitral valve ring 22, thereby blocking blood flow and preventing paravalvular leakage.

[0068] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0069] The above-mentioned embodiments only express several implementation methods of the present invention, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the invention patent. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present invention, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention shall be subject to the attached claims.

Claims

1. A valve stent, characterized in that: It includes a leaflet support, an elastic member and a skirt support, the leaflet support has a first end and a second end opposite to the first end, the skirt support extends radially outward from the leaflet support, the skirt support is arranged close to the first end of the leaflet support, the valve support also includes a barb arranged on the leaflet support and close to the second end, the barb extends radially outward from the leaflet support and extends toward the first end, and the axial distance between one end of the barb close to the leaflet support and one end of the skirt support close to the leaflet support is in the range of 10mm to 20mm; the elastic member is arranged between the leaflet support and the skirt support, and the elastic member protrudes radially outward from the leaflet support; The elastic member includes a plurality of elastic wires arranged around the periphery of the leaflet support, the plurality of elastic wires are interconnected to form a circle of wavy rings, the wavy rings include a plurality of distal vertices, a plurality of proximal vertices and a support body connecting adjacent distal vertices and proximal vertices, the plurality of distal vertices are respectively connected to the skirt support, and the plurality of proximal vertices are respectively connected to the leaflet support.

2. The valve stent according to claim 1, characterized in that: The length of the barb ranges from 2mm to 3mm, or from 3mm to 5mm, or from 5mm to 10mm.

3. The valve stent according to claim 1, characterized in that: The angle between the barb and the leaflet support ranges from 20° to 45°, or from 45° to 60°, or from 60° to 70°.

4. The valve stent according to claim 1, characterized in that: The ratio of the width to the thickness of the barb is in the range of 0.75 to 1, or 1 to 1.2, or 1.2 to 1.

5.

5. The valve stent according to claim 1, characterized in that: The barb includes a fixing portion and a bending portion, one end of the fixing portion is connected to the leaflet support, and the other end is connected to the bending portion, the bending portion is bent toward the longitudinal center axis of the leaflet support, and the angle between the bending portion and the fixing portion ranges from 110° to 160°.

6. The valve stent according to claim 1, characterized in that: A fillet is provided at the position where the leaflet support is connected to the barb, and the radius of the fillet is in the range of 0.02mm to 0.30mm.

7. The valve stent according to claim 1, characterized in that: The distance between one end of the skirt support close to the leaflet support and the first end is 1 / 4 to 1 / 2 of the axial length of the leaflet support.

8. The valve stent according to claim 1, characterized in that: The leaflet stent includes a plurality of corrugations arranged at intervals along the axial direction of the leaflet stent and a plurality of connecting rods connecting the plurality of corrugations. The connecting rods extend along the axial direction of the leaflet stent, and the barbs are arranged on the connecting rods.

9. The valve stent according to claim 1, characterized in that: The valve support also includes a connecting rod and a connecting piece, one end of the connecting rod is connected to the second end, and one end of the connecting rod away from the second end is connected to the connecting piece.

10. The valve stent according to claim 9, characterized in that: The valve support also includes a tether connected to the connector.

11. An artificial heart valve, characterized in that: It comprises the valve support as described in any one of claims 1 to 10, and also comprises a flow blocker and a leaflet, wherein the flow blocker covers the leaflet support and the skirt support, and the leaflet is located inside the leaflet support and fixedly connected to the leaflet support and / or the flow blocker.

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