A self-expanding atrioventricular valve prosthetic device

Abstract

The present invention discloses a self-expanding atrioventricular valve prosthesis device, comprising: a main body portion, which is a frame structure, and the main body portion is implanted at the native valve annulus of the heart. The main body portion includes an inflow section, an outflow section and a transition section. The inflow section is located at the atrial end, the outflow section is located at the ventricular end, and the transition section is located between the inflow section and the outflow section; it further includes at least one artificial valve leaf, which is fixed to the transition section of the main body portion, and the artificial valve leaf is provided with a connecting portion; it further includes a chordae tendineae portion, one end of which is fixed, and the other end is connected to the artificial valve leaf through the connecting portion. The present invention restricts the movement range of the artificial valve leaf through the chordae tendineae portion, and the connecting portion prevents the chordae tendineae portion from tearing and stress concentration on the valve leaf, thereby increasing the durability of the artificial valve leaf.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly relates to a self-expanding atrioventricular valve prosthesis device implanted in the heart for replacing a native valve. Background Art

[0002] The heart contains four chambers, the right atrium (RA), the right ventricle (RV), the left atrium (LA), and the left ventricle (LV). During the entire cardiac cycle, the pumping actions on the left and right sides of the heart generally occur synchronously. The valves that separate the atria from the ventricles are called atrioventricular valves, and the atrioventricular valves act as one-way valves to ensure the normal flow of blood within the heart chambers. The atrioventricular valve between the left atrium and the left ventricle is the mitral valve, and the atrioventricular valve between the right atrium and the right ventricle is the tricuspid valve. The pulmonary valve directs blood flow into the pulmonary artery and from there to the lungs; the blood returns to the left atrium through the pulmonary veins. The aortic valve guides blood flow through the aorta and from there to the periphery. There is usually no direct connection between the ventricles or between the atria.

[0003] At the beginning of ventricular filling (diastole), the aortic valve and the pulmonary valve close to prevent backflow from the arteries into the ventricles. Shortly thereafter, the atrioventricular valves open to allow unobstructed flow from the atria into the corresponding ventricles. Shortly after the start of ventricular systole (i.e., ventricular emptying), the tricuspid valve and the mitral valve normally close, thus forming a seal that prevents backflow from the ventricles into the corresponding atria.

[0004] When the atrioventricular valve has problems and cannot function properly, it will lead to improper closure. The atrioventricular valve is a complex structure, usually including an annulus, leaflets, chordae tendineae, and supporting structures. Each atrium is connected to its valve through the atrial vestibule. The mitral valve has two leaflets, and the similar structure of the tricuspid valve has three leaflets, and the attachment or engagement of the corresponding surfaces of each leaflet with each other helps to provide the closure or seal of the valve, thus preventing blood from flowing in the wrong direction. Failure of the leaflets to seal during ventricular contraction is called poor coaptation, which can cause blood to flow backward (regurgitation) through the valve. Heart valve insufficiency can have serious consequences for patients, often leading to heart failure, reduced blood flow, decreased blood pressure, and / or reduced oxygen flow to body tissues. Mitral valve insufficiency can also cause blood to flow back from the left atrium into the pulmonary veins, resulting in congestion. Severe valve insufficiency, if untreated, can lead to permanent disability or death.

[0005] In recent years, there have been some breakthroughs in the field of artificial valves. However, due to the complexity of the mitral valve and its surrounding structures, the treatment of the mitral valve still faces huge challenges. For example, 1. How to solve the problems of leaflet prolapse and eversion: After the implantation of an artificial valve prosthesis, during heart contraction, due to excessive ventricular pressure, there is a risk of leaflet prolapse and eversion. 2. How to reduce leaflet stress and increase the durability of artificial valves. The tricuspid valve also has the above problems. Summary of the Invention

[0006] The present invention provides a self-expanding atrioventricular valve prosthesis device, which can solve the above-mentioned defects in the prior art.

[0007] The technical solution of the present invention is as follows:

[0008] A self-expanding atrioventricular valve prosthesis device, comprising: a main body part, which is a frame structure, the main body part is implanted at the native valve annulus of the heart, the main body part includes an inflow section, an outflow section and a transition section, the inflow section is located at the atrial end, the outflow section is located at the ventricular end, and the transition section is located between the inflow section and the outflow section; at least one artificial valve leaf, fixed to the transition section of the main body part, the artificial valve leaf is provided with a connecting part; at least one chordae tendineae part, one end of the chordae tendineae part is fixed, and the other end is connected to the artificial valve leaf through the connecting part, and the chordae tendineae part is used to limit the movement range of the artificial valve leaf and increase the durability of the artificial valve leaf.

[0009] During cardiac contraction, due to excessive ventricular pressure, there is a risk of prolapse or eversion of the artificial valve leaf. Starting from reducing the stress of the artificial valve leaf and increasing the durability of the valve leaf, the present invention connects the valve leaf by providing a chordae tendineae part. When the artificial valve leaf is about to prolapse or evert, the chordae tendineae part generates a pulling force on the valve leaf, so that the valve leaf returns to the normal closed state, so that the valve leaf can normally close the blood passage in the closed state, that is, the chordae tendineae part here plays the role of chordae tendineae. Considering that when the chordae tendineae part is directly connected to the valve leaf, the valve leaf will be subjected to tearing force and stress concentration, which will damage the structure of the valve leaf over time. Therefore, by providing a connecting part on the valve leaf, the chordae tendineae part is indirectly connected to the valve leaf through the connecting part, and the acting force generated by the chordae tendineae part is applied to the valve leaf through the connecting part, thereby reducing the stress of the valve leaf and increasing the durability of the valve leaf.

[0010] In some embodiments, the connecting part is arranged on the leaf surface of the artificial valve leaf, on the side near the ventricular end. The connecting part arranged on the leaf surface can increase the contact area with the valve leaf, thereby reducing stress concentration. In some embodiments, the connecting part is arranged at the edge of the artificial valve leaf. The connecting part located at the edge of the valve leaf can reduce the acting force exerted by the chordae tendineae part, thereby reducing stress. In some embodiments, there are multiple connecting parts, which are respectively arranged on the leaf surface and the edge of the valve leaf, and the number of connecting parts can be set according to actual clinical needs.

[0011] In some embodiments, the artificial leaflet includes a plurality of free edges, and the arc length of the connection portion connected to any one of the free edges occupies 1 / 12 - 1 / 3 of the arc length of the corresponding free edge. The longer the arc length of the connection portion connected to the free edge, the smaller the movement range of the leaflet. If the movement range is too small, it will affect the effective opening area of the leaflet. On the contrary, the shorter the arc length of the connection portion connected to the free edge, the higher the risk of friction between the leaflet and the main body portion.

[0012] In some embodiments, the connection portion and the artificial leaflet are configured to have a predetermined angle α, where 0 < α ≤ 180°. At this angle, the connection portion will not interfere with the normal opening and closing of the artificial leaflet, nor will it block the outflow tract.

[0013] In some embodiments, the chord portion includes a first connection end and a second connection end. The first connection end is connected to the connection portion, and the second connection end is fixed to the main body portion, or the second connection end is fixed to the native tissue. When the chord portion is connected to the main body portion, the connection portion, the chord portion, and the main body portion can be integrally implanted, thus simplifying the design of the delivery system. When the chord portion is connected to the tissue, it can avoid blocking the outflow tract by the connection portion and the chord portion. At the same time, compared with the connection between the connection portion and the chord portion, the design angle α will be larger, so the configuration of the angle between the connection portion and the leaflet surface is more flexible.

[0014] In some embodiments, the second connection end is fixed to the inflow section or the outflow section. It is preferably fixed to the outflow section because the distance between the outflow section and the connection portion is small, so the material used for the chord portion can be reduced. In addition, compared with fixing to the inflow section, fixing the second connection end to the outflow section can prevent entanglement between the chord portion and the main body portion.

[0015] In some embodiments, the second connection end is fixed to the upper tissue or the lower tissue, preferably fixed to the lower tissue.

[0016] In some embodiments, when the second connection end is connected to the tissue, the second connection end of the chord portion is configured to have the same shape as the corresponding connection portion. When the shape of the second connection end connected to the tissue is the same as that of the connection portion, the chord portion and the connection portion can be stressed evenly, and to a certain extent, the durability of the chord portion and the connection portion is ensured.

[0017] In some embodiments, when the artificial leaflet is in the closed state, the chord portion is configured to be on the same straight line as the connection portion. At this time, the force exerted by the chord portion on the connection portion is the smallest, thereby enhancing the durability of the connection portion.

[0018] In some embodiments, a connection hole is further provided at a position near the center of the connection part, and the chordal part is connected to the connection part through the connection hole, making the connection between the chordal part and the connection part simpler.

[0019] Furthermore, in some embodiments, a protective layer is provided on the circumferential direction of the connection hole to buffer the pulling force generated by the chordal part on the connection part.

[0020] In some embodiments, the self-expanding atrioventricular valve prosthesis device further includes at least one clamping member for connection. The clamping member can be connected to the part to be connected by at least one of sewing, riveting, inlaying, etc., preferably sewing.

[0021] In some embodiments, when the number of the artificial valve leaflets is configured to be at least two, the clamping member is clamped on the artificial valve leaflets for connecting two adjacent artificial valve leaflets, so as to reduce the movement range of the artificial valve leaflets, thereby avoiding the friction between the movable artificial valve leaflets and the main body part and improving the durability of the artificial valve leaflets. After the movement range of the artificial valve leaflets is reduced, correspondingly, the movement ranges of the connection part and the chordal part are also limited, further improving the durability of the chordal part and the connection part.

[0022] In some embodiments, the connection part can be optionally integrally prepared with the artificial valve leaflet and / or the chordal part. For example, the connection part is integrally prepared with the artificial valve leaflet and then connected to the chordal part, or the connection part is integrally prepared with the chordal part and then connected to the artificial valve leaflet; or the artificial valve leaflet, the connection part and the chordal part are integrally prepared. Among them, the chordal part can be formed into a linear structure, a sheet structure, and the chordal part can also be formed into a spiral structure to provide a certain degree of stretchability.

[0023] In some embodiments, the artificial valve leaflet, the connection part and the chordal part are respectively prepared and then connected. The forming methods of the artificial valve leaflet, the connection part and the chordal part can be selected according to actual clinical needs.

[0024] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0025] 1. For the atrioventricular valve prosthesis device of the present invention, by using the chordal part to connect the artificial valve leaflet and limiting the movement range of the valve leaflet, the prolapse or eversion of the artificial valve leaflet can be prevented; further, by adding a connection part on the valve leaflet, the direct connection between the artificial valve leaflet and the chordal part is avoided, and the tearing force and stress received by the valve leaflet are relieved, thereby increasing the durability of the valve leaflet; in addition, the present invention can limit the movement range of the valve leaflet through the chordal part, prevent the collision between the valve leaflet and the main body part, and increase the durability of the valve leaflet.

[0026] 2. By setting the arc length of the connecting part and the connecting part of the free edge in the atrioventricular valve prosthesis device of the present invention, and by using the clamping member to realize the connection between two adjacent valve leaflets, the movement range of the valve leaflets can be further restricted, the collision between the valve leaflets and the main body part can be avoided, and at the same time, the movement amplitude of the connecting part can be reduced, and the movement range of the chordae tendineae part can be further reduced, thereby increasing the durability of the chordae tendineae part. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1 is a schematic structural diagram after the atrioventricular valve prosthesis device of the present invention is implanted;

[0028] Figure 2 is a schematic structural diagram of the main body part of the present invention;

[0029] Figure 3 is a schematic structural diagram of the artificial valve leaflet of Embodiment 1 of the present invention;

[0030] Figure 4 is a schematic structural diagram of another artificial valve leaflet of Embodiment 1 of the present invention;

[0031] Figure 5 is a partial schematic structural diagram of the atrioventricular valve prosthesis device of Embodiment 1 of the present invention;

[0032] Figure 6 is a partial schematic structural diagram of another atrioventricular valve prosthesis device of Embodiment 1 of the present invention;

[0033] Figure 7 is a partial schematic structural diagram of the artificial valve leaflet of Embodiment 1 of the present invention in the open state;

[0034] Figure 8 is a partial schematic structural diagram of the artificial valve leaflet of Embodiment 1 of the present invention in the closed state;

[0035] Figure 9 is a partial schematic structural diagram of another atrioventricular valve prosthesis device of Embodiment 1 of the present invention;

[0036] Figure 10 is a partial schematic structural diagram of the atrioventricular valve prosthesis device of Embodiment 2 of the present invention;

[0037] Figure 11 is another partial schematic structural diagram of the atrioventricular valve prosthesis device of Embodiment 2 of the present invention;

[0038] Figure 12 is a partial schematic structural diagram of the atrioventricular valve prosthesis device of Embodiment 3 of the present invention;

[0039] Figure 13 is another partial schematic structural diagram of the atrioventricular valve prosthesis device of Embodiment 3 of the present invention;

[0040] Figure 14It is a schematic three-dimensional structure diagram of the clamping member according to Embodiment 4 of the present invention;

[0041] Figure 15 It is a schematic structural diagram of the artificial valve leaflet connected by sewing in Embodiment 4 of the present invention;

[0042] Figure 16 It is a schematic structural diagram of the artificial valve leaflet and the clamping member in Embodiment 4 of the present invention.

[0043] Reference numerals: atrioventricular valve prosthesis device 100; first region 101; second region 102; third region 103; main body portion 110; artificial valve leaflet 130; connecting portion 140; chordae tendineae portion 150; inflow section 111; transition section 112; outflow section 113. Detailed implementation manners

[0044] The present invention provides a self-expanding atrioventricular valve prosthesis device, including a main body portion, an artificial valve leaflet and a chordae tendineae portion, which is used to replace a diseased native valve and play a role in opening or closing a blood passage. Among them, the atrioventricular valve prosthesis device can be designed as a mitral valve prosthesis for replacing a diseased mitral valve, or can be designed as a tricuspid valve prosthesis for replacing a diseased tricuspid valve. Taking the mitral valve as an example, the present invention will be further described below.

[0045] As Figure 1 shown, the atrioventricular valve prosthesis device 100 is a mitral valve prosthesis, which can be longitudinally divided into a first region 101, a second region 102 and a third region 103. After the mitral valve prosthesis is implanted into the human body, the first region 101 adheres to the native mitral valve annulus of the heart to prevent the prosthetic valve from falling from the left atrium into the left ventricle, and the second region 102 is used to carry the artificial valve leaflet 130, and at the same time relies on the anchoring force of the main body portion to support on the tissue, playing an anchoring and sealing role. As an optional item, the mitral valve prosthesis can only replace the anterior leaflet or the posterior leaflet of the mitral valve, that is, a semi-artificial valve prosthesis is used in cooperation with a half native valve leaflet.

[0046] Corresponding to the valve prosthesis, referring to Figure 2 , the main body portion 110 is divided into an inflow section 111, a transition section 112 and an outflow section 113, which can provide several functions for the valve prosthesis, including serving as a main structure, an anchoring structure (including an anchor claw structure for grasping the valve leaflet, or stabbing into the valve leaflet, etc.), a support for carrying the internal artificial valve leaflet 130, the connecting portion 140 and the chordae tendineae portion 150, serving as a seal for suppressing paravalvular leakage between the valve prosthesis and the native valve, a connection structure with the delivery system (hanging ear or fixing ear 114), and so on.

[0047] The main body portion 110 is a frame structure with grid holes, which is woven or cut from a metal material. If the valve prosthesis is implanted by a transcatheter intervention method, the main body portion 110 is made of nitinol or other biocompatible materials with shape memory characteristics, or materials that can be elastically or plastically deformed, such as balloon-expandable materials. After being implanted, the main body portion 110 can self-expand into a predetermined structure, thereby anchoring at the native valve annulus.

[0048] The artificial leaflets 130 dynamically switch between an open state and a closed state. In the closed state, the artificial leaflets 130 are closed or joined in a sealing abutting manner, and their number can be the same as or different from that of the native leaflets. The artificial leaflets 130 can be formed from any suitable material or combination of materials. Biotissues can be selected, such as chemically stable tissues of heart valves from animals (such as pigs), or animal pericardial tissues such as those from cows (bovine pericardium), sheep (ovine pericardium), pigs (porcine pericardium), or horses (equine pericardium), or they can be made of small intestinal submucosal tissue. In addition, synthetic materials can also be selected, such as expanded polytetrafluoroethylene or polyester. Optionally, it also includes thermoplastic polycarbonate polyurethane, polyether polyurethane, segmented polyether polyurethane, silicone polyether polyurethane, silicone-polycarbonate polyurethane, and ultra-high molecular weight polyethylene. Additionally, biocompatible polymers are also included, optionally including polyolefins, elastomers, polyethylene glycol, polyethersulfone, polysulfone, polyvinylpyrrolidone, polyvinyl chloride, other fluorine-containing polymers, silicone polyesters, siloxane polymers and / or oligomers, and / or polyesters, as well as block copolymers using them. Optionally, the leaflets 130 have a surface treated (or reacted) with an anticoagulant, and the anticoagulant includes but is not limited to heparinized polymers.

[0049] The force exerted on the leaflets 130 by the chordae tendineae portion 150 in the present invention can limit the movement range of the artificial leaflets 130, thereby preventing the artificial leaflets 130 from eversion or prolapse.

[0050] In the description of the present invention, it should be noted that "leaflet" and "artificial leaflet" have the same meaning. The term "atrial end" refers to the end close to the atrium, and the term "ventricular end" refers to the end close to the ventricle.

[0051] In the description of the present invention, it should be noted that the orientation or positional relationship indicated by terms such as "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. is based on the orientation or positional relationship shown in the drawings. It is 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 construed as a limitation to the present invention. In addition, the terms "first", "second", and "third" are only used for descriptive purposes and cannot be construed as indicating or implying relative importance.

[0052] In the description of the present invention, it should be noted that, unless otherwise clearly defined and limited, the terms "installed", "connected", and "coupled" 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 directly connected or indirectly connected through an intermediate medium, and it can be the communication inside two components. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific situations.

[0053] As used in this specification, the singular forms "a", "an", and "the" include plural objects unless the context clearly indicates otherwise. As used in this specification, the term "or" is generally used in the sense of including "and / or" unless the context clearly indicates otherwise.

[0054] The present invention will be further described below with reference to specific embodiments.

[0055] Embodiment 1

[0056] This embodiment provides a self-expanding atrioventricular valve prosthesis device. Refer to Figures 1 - 9 , the atrioventricular valve prosthesis device includes a main body part 110, at least one artificial valve leaf 130, and a chordae tendineae part 150. Among them, the main body part is a frame structure implanted at the native valve annulus of the heart. The main body part includes an inflow section, an outflow section, and a transition section. The inflow section is located at the atrial end, the outflow section is located at the ventricular end, and the transition section is located between the inflow section and the outflow section. The artificial valve leaf 130 is fixed to the transition section of the main body part. A connecting part 140 is arranged at the near edge of the artificial valve leaf 130. One end of the chordae tendineae part is fixed, and the other end is connected to the artificial valve leaf 130 through the connecting part 140 to limit the movement range of the artificial valve leaf 130 and increase the durability of the artificial valve leaf 130.

[0057] During systole, due to excessive ventricular pressure, there is a risk of prolapse or eversion of the artificial valve leaflet 130. In this embodiment, starting from reducing the stress on the artificial valve leaflet 130 and increasing the durability of the leaflet 130, a chordal part is provided to connect the leaflet 130. When the artificial valve leaflet 130 is about to prolapse or evert, the chordal part generates a pulling force on the leaflet 130, causing the leaflet 130 to return to its normal closed form, so that the leaflet 130 can normally close the blood passage in the closed state. That is, in this embodiment, the chordal part 150 functions as a chord. Considering that when the chordal part 150 is directly connected to the leaflet 130, the leaflet 130 will be subjected to tearing force and stress concentration, which will damage the structure of the leaflet 130 over time. Therefore, in this embodiment, a connecting part 140 is provided on the leaflet 130, so that the chordal part 150 is indirectly connected to the leaflet 130 through the connecting part 140, and the acting force generated by the chordal part 150 is applied to the leaflet 130 through the connecting part 140, thereby reducing the stress on the leaflet 130 and increasing the durability of the leaflet 130.

[0058] Specifically, the connecting part 140 can be arranged at the edge of the artificial valve leaflet 130. Refer to Figure 3 , the artificial valve leaflet has a fixed edge 134 and is fixed to the main body part 110 through the fixed edge 134. The number of connecting parts 140 is one and is arranged at the edge of the leaflet. Figure 4 In , three connecting parts 140 are arranged. The connecting parts 140 located at the edge of the leaflet can reduce the acting force exerted by the chordal part and thus reduce the stress. Of course, the connecting part 140 can also be arranged on the surface of the artificial valve leaflet 130. As shown in Figure 5 , arranging it on the surface can increase the contact area between the connecting part 140 and the leaflet 130, thereby reducing stress concentration; the connecting part 140 is preferably arranged on the surface of the side closer to the ventricular end. Or, the connecting parts 140 can be respectively arranged at the edge and on the surface of the artificial valve leaflet 130. As shown in Figure 6 , at this time, the number of connecting parts 140 is multiple, and each connecting part 140 is respectively connected to a chordal part 150.

[0059] The artificial valve leaflet 130 includes multiple free edges. The connecting part 140 can be located at any position of any free edge. Among them, the arc length of the connecting part 140 connected to any free edge occupies 1 / 12 - 1 / 3 of the arc length of the free edge where it is located. The longer the arc length of the connecting part 140 connected to the free edge, the smaller the movement range of the leaflet 130. If the movement range is too small, it will affect the effective opening area of the leaflet 130. On the contrary, the shorter the arc length of the connecting part 140 connected to the free edge, the greater the risk of friction between the leaflet 130 and the main body part 110.

[0060] Specifically, continue to refer to Figure 6, in this embodiment, the artificial leaflet 130 includes a first free edge 131, a second free edge 132, a third free edge 133 and a fixed edge 134, and the fixed edge 134 is fixed to the transition section 112 of the main body 110; the third free edge 133 is located between the first free edge 131 and the second free edge 132, and the first free edge 131, the second free edge 132 and the third free edge 133 together form the edge of the artificial leaflet 130. Among them, the first free edge 131 is provided with a first connecting portion 141, the second free edge 132 is provided with a second connecting portion 142, the third free edge 133 is provided with a third connecting portion 143, and the leaf surface of the artificial leaflet 130 is provided with a fourth connecting portion 144.

[0061] The third connecting portion 143 is preferably located at the central position of the third free edge 133. At this time, when the heart is in diastole, the forces exerted by the chordal portion on both sides of the third connecting portion 140 are uniform, thereby improving the durability of the third connecting portion 143; at the same time, when the heart contracts, the third connecting portion 143 can prevent the artificial leaflet 130 from prolapsing or eversion. Of course, in other alternative embodiments, the connecting portion 140 can be located on any one, any two or any three of the first free edge 131, the second free edge 132, the third free edge 133 and the leaf surface of the leaflet 130, and the number and position of the connecting portion 140 should be selected according to actual clinical needs, which are not limited here.

[0062] See Figure 7 , Figure 8 , which respectively show partial structural schematic diagrams of the artificial leaflet 130, the connecting portion 140, the chordal portion 150 and the main body 110. In this embodiment, the connecting portion 140 and the artificial leaflet 130 are configured to have a predetermined angle α, 0 < α ≤ 180°, and at this angle, the connecting portion 140 will not interfere with the normal opening and closing of the artificial leaflet 130, nor will it block the outflow tract. Figure 7 The artificial leaflet 130 shown in Figure 8 is in an open state,

[0063] The shape of the connecting portion 140 can be at least one of a triangle, a quadrilateral, a pentagon, a quasi-circular shape, a shape with a smooth contour, etc. Quadrilaterals include squares, rectangles, rhombuses, trapezoids, etc. The quasi-circular shape is a regular polygon with no less than six sides, and the shape with a smooth contour includes circles, oval shapes, semi-circles, semi-oval shapes, petal shapes, etc. In this embodiment, a shape with a smooth contour is preferably used. See Figures 3 - 6 , the connecting portion 140 is semi-circular, which is more conducive to stress dispersion.

[0064] Further, continue to refer to Figures 6 - 8, the chordal part 150 includes a first connection end D1 and a second connection end D2. The first connection end D1 is connected to the connection part 140, and the second connection end D2 is fixed to the main body part 110. When the chordal part 150 is connected to the main body part 110, the connection part 140, the chordal part 150, and the main body part 110 can be integrally implanted, thus simplifying the design of the delivery system.

[0065] In this embodiment, the first connection part 141 connects the first chordal part 151, the second connection part 142 connects the second chordal part 152, the third connection part 143 connects the third chordal part 153, and the fourth connection part 143 connects the fourth chordal part 154. Among them, the first chordal part 151, the second chordal part 152, the third chordal part 153, and the fourth chordal part 154 are respectively fixed at predetermined positions of the outflow section 113. Of course, in other alternative embodiments, the first chordal part 151, the second chordal part 152, the third chordal part 153, and the fourth chordal part 154 can be independently fixed to the inflow section 111. When the chordal part 150 is fixed to the inflow section 111, the second connection end D2 of the chordal part 150 extends from the mesh hole of the frame structure or from the outflow section 113 to the inflow section 111 and then is fixed. Compared with being fixed to the inflow section 111, since the distance between the connection part 140 and the outflow section 113 is smaller, the material used can be reduced; on the other hand, directly fixing the connection part 140 to the outflow section 113 can avoid entanglement between the chordal part 150 and the frame structure of the main body part.

[0066] Furthermore, referring to Figure 9 , the connection side shapes of the two chordal parts 150 and the main body part 110 can be bridge-shaped, umbrella-shaped, conical, etc., preferably conical. The second connection end D2 of the chordal part 150 is preferably wrapped around the main body part 110. When the heart contracts, the force received by the chordal part 150 can be evenly dispersed on the main body part 110, thus ensuring the durability of the chordal part 150.

[0067] In a preferred embodiment, the chordal part 150 is configured to be in the same straight line as the connection part 140 when the artificial valve leaf 130 is in the closed state, as Figure 7 , Figure 8 shown. At this time, the force exerted by the chordal part 150 on the connection part 140 is the smallest, thereby enhancing the durability of the connection part 140.

[0068] Further, the connecting portion 140 can be integrally prepared with the artificial valve leaflet 130 and then connected to the chordal portion 150. Alternatively, the connecting portion 140 can also be integrally prepared with the chordal portion 150 and then connected to the artificial valve leaflet 130. Or, the artificial valve leaflet 130, the connecting portion 140, and the chordal portion 150 are integrally prepared. Of course, the artificial valve leaflet 130, the connecting portion 140, and the chordal portion 150 can also be separately prepared and then combined. The combination methods include but are not limited to sewing, gluing, riveting, inlaying, clip fixing, etc. The forming and connection methods of the artificial valve leaflet 130, the connecting portion 140, and the chordal portion 150 can be selected according to actual needs and will not be elaborated here.

[0069] In this embodiment, the materials of the artificial valve leaflet 130, the connecting portion 140, and the chordal portion 150 can be the same or different. Preferably, the chordal portion 150 is made of a material with certain stretchability and formed into a linear structure or a sheet structure; or the chordal portion 150 is formed into a structure with certain stiffness, such as a spiral shape, so as to provide a certain pulling force when the valve leaflet 130 turns outward or prolapses. The materials of the artificial valve leaflet 130, the connecting portion 140, and the chordal portion 150 do not limit the scope of the present invention and can be selected according to actual clinical needs.

[0070] Specifically, the materials of the connecting portion 140 and the chordal portion 150 can be selected from biological tissues, synthetic materials, or biocompatible polymers. Among them, biological tissues are, for example, chemically stable tissues from the heart valves of animals (such as pigs), or animal pericardial tissues such as cows (bovine pericardium), sheep (ovine pericardium), pigs (porcine pericardium), or horses (equine pericardium), and can also be made of small intestinal submucosa tissue; synthetic materials are, for example, expanded polytetrafluoroethylene or polyester. Optionally, it also includes thermoplastic polycarbonate polyurethane, polyether polyurethane, segmented polyether polyurethane, silicone polyether polyurethane, silicone-polycarbonate polyurethane, and ultra-high molecular weight polyethylene; biocompatible polymers optionally include polyolefins, elastomers, polyethylene glycol, polyethersulfone, polysulfone, polyvinylpyrrolidone, polyvinyl chloride, other fluorine-containing polymers, silicone polyester, silicone polymers and / or oligomers, and / or polylactones, and block copolymers using them.

[0071] Embodiment 2

[0072] This embodiment provides a self-expanding atrioventricular valve prosthesis device. Refer to Figure 10 、 Figure 11 , in which the structure of the atrioventricular valve prosthesis device is similar to that in Embodiment 1, except that the second connection end D2 of the chordal portion 150 in this embodiment is fixed to the native tissue.

[0073] The native tissue includes two parts, namely the tissue at the atrial end called the upper tissue and the tissue at the ventricular end called the lower tissue. The lower tissue includes, but is not limited to, papillary muscles, the apex of the heart, the interventricular septum, etc. When the chordal part 150 is connected to the tissue 170, it can avoid the blockage of the outflow tract by the connecting part 140 and the chordal part 150. At the same time, compared with the connection between the connecting part 140 and the main body part, the design angle α will be larger.

[0074] In this embodiment, the second connection end D2 of the chordal part 150 is preferably fixed to the lower tissue 172 to prevent entanglement between the second connection end D2 and the main body part 110 when the second connection end D2 passes through the frame.

[0075] During heart contraction, to ensure the durability of the chordal part 150, the force exerted on the chordal part 150 needs to be evenly distributed on the tissue 170. However, if the area of the second connection end D2 of the chordal part 150 and the tissue 170 is too large, it is easy to interfere with the outflow tract of the blood and affect hemodynamics. If the area is too small, the forces on the chordal part 150 and the connecting part 140 will increase accordingly. Therefore, preferably, the second connection end D2 of the chordal part 150 has the same shape as the corresponding connecting part 140. When the shape of the second connection end D2 connected to the tissue 170 is the same as that of the connecting part 140, the chordal part 150 and the connecting part 140 can be evenly stressed, and to a certain extent, the durability of the chordal part 150 and the connecting part 140 is ensured.

[0076] Embodiment 3

[0077] This embodiment provides a self-expanding atrioventricular valve prosthesis device, which is an improvement based on Embodiment 1 or Embodiment 2. Among them, the connecting part 140 is further provided with a connecting hole Q, see Figure 12 , and the chordal part 150 is connected to the connecting part 140 through the connecting hole Q. The connecting hole Q can be located at any position of the connecting part 140, preferably at the central position of the connecting part 140 to make the stress dispersion uniform. The number of connecting holes Q is at least 1, and the shape can be rectangular, circular, triangular, etc., preferably circular, because the circular shape can make the tensile force received by the connecting part 140 evenly distributed on the connecting part 140 and the chordal part 150.

[0078] Furthermore, a protective layer P is provided on the circumference of the connecting hole Q, see Figure 13 , where the protective layer P can be a biocompatible material such as a metal sheet, a PTFE membrane, or polyester wrapped around the circumference of the connecting hole Q. The protective layer P is used to buffer the tensile force of the chordal part 150 on the connecting part 140 when the artificial valve leaf 130 moves, so as to increase the durability of the connecting part 140.

[0079] Embodiment 4

[0080] This embodiment provides a self-expanding atrioventricular valve prosthesis device, which is an improvement based on Embodiment 1, Embodiment 2 or Embodiment 3. Among them, the atrioventricular valve prosthesis device further includes at least one clamping member 160 for connection, such as Figure 14 , Figure 16 as shown.

[0081] The clamping member 160 can be connected to the part to be connected by at least one of sewing, riveting, inlaying, etc., preferably sewing. For example, the clamping member 160 can connect the connecting portion 140 and the artificial valve leaflet 130, and can also connect the connecting portion 140 and the chordae tendineae portion 150.

[0082] In one embodiment, when the number of artificial valve leaflets 130 is set to at least two, the clamping member 160 is clamped on the artificial valve leaflets 130 to connect adjacent two artificial valve leaflets 130, so as to reduce the movement range of the artificial valve leaflets 130.

[0083] Specifically, the clamping member 160 is a clip. Among them, the clip includes a valve leaflet suture portion 162 and a main body suture portion 161. The width of the clip is d. The free edge portions of adjacent two artificial valve leaflets are clamped by the clip. The clip is fixed on the valve leaflet 130 through the valve leaflet suture portion 162, and the clip is fixed on the main body portion 110 through the main body suture portion 161, so as to fix the artificial valve leaflet 130.

[0084] Figure 15 The connection between the artificial valve leaflets 130 is realized by sewing. L1 is the distance from the sewing point to the closing point O of the artificial valve leaflet. Figure 16 The connection between the artificial valve leaflets 130 is realized by sewing the clip. L2 is the distance from the end of the clip away from the main body portion to the closing point O of the artificial valve leaflet. Among them, L1 = L2 + d, that is, L1 > L2. Therefore, Figure 16 the movement range of the artificial valve leaflets 130 is less than Figure 15 the movement amplitude of the artificial valve leaflets 130. After the artificial valve leaflets 130 are sewn with the clip, the movement range is reduced, thereby avoiding the friction between the moving artificial valve leaflets 130 and the main body portion, and improving the durability of the artificial valve leaflets 130. After the movement range of the artificial valve leaflets 130 is reduced, correspondingly, the movement ranges of the connecting portion 140 and the chordae tendineae portion 150 are also limited, further improving the durability of the chordae tendineae portion 150 and the connecting portion 140.

[0085] Among them, the material of the clamping member 160 can be at least one of biocompatible materials such as metal, pericardium, PTFE, etc.

[0086] The above-disclosed are only the preferred embodiments of the present invention. The preferred embodiments do not describe all the details in detail, nor do they limit the invention to the specific embodiments described. It should be understood that these embodiments are only used to illustrate the present invention, rather than to limit the protection scope of the present invention.

[0087] In practical applications, the improvements and adjustments made by those skilled in the art based on the present invention still fall within the protection scope of the present invention. Obviously, many modifications and variations can be made according to the content 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 those skilled in the art 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. An expandable atrioventricular valve prosthetic device, characterized in that, Comprising: A main body part, which is a frame structure. The main body part is implanted at the native valve annulus of the heart. The main body part includes an inflow section, an outflow section and a transition section. The inflow section is located at the atrial end, the outflow section is located at the ventricular end, and the transition section is located between the inflow section and the outflow section; At least one artificial valve leaflet, which is fixed to the transition section of the main body part. The artificial valve leaflet is provided with at least one connecting part; At least one chordae tendineae part. One end of the chordae tendineae part is fixed, and the other end is connected to the artificial valve leaflet through the connecting part. The chordae tendineae part is used to limit the movement range of the artificial valve leaflet and increase the durability of the artificial valve leaflet; Wherein, the connecting part is arranged at the edge of the artificial valve leaflet; The artificial valve leaflet includes a plurality of free edges. The arc length of the connecting part connected to any one of the free edges occupies 1 / 12 - 1 / 3 of the arc length of the free edge where it is located; A predetermined angle α is configured between the connecting part and the artificial valve leaflet to avoid the connecting part interfering with the normal opening and closing of the artificial valve leaflet and blocking the outflow tract, wherein 0 < α ≤ 180°; 2. The self-expanding atrioventricular valve prosthesis device according to claim 1, characterized in that, The chordae tendineae part includes a first connection end and a second connection end. The first connection end is connected to the connecting part; 3. The self-expanding atrioventricular valve prosthesis device according to claim 2, characterized in that, The second connection end is fixed to the main body part; 4. The self-expanding atrioventricular valve prosthesis device according to claim 3, wherein The second connection end is fixed to the inflow section or the outflow section; 5. The self-expanding atrioventricular valve prosthesis device according to claim 2, wherein, The second connection end is fixed to the native tissue; 6. The self-expanding atrioventricular valve prosthesis device according to claim 5, characterized in that, The second connection end is fixed to the upper tissue or the lower tissue; 7. The self-expanding atrioventricular valve prosthesis device according to claim 5, characterized in that, When the second connection end is connected to the tissue, the second connection end of the chordae tendineae part is configured to have the same shape as the corresponding connecting part; 8. The self-expanding atrioventricular valve prosthetic device according to claim 1, characterized in that, When the artificial valve leaflet is in the closed state, the chordae tendineae part is configured to be on the same straight line as the connecting part; 9. The self-expanding atrioventricular valve prosthetic device according to any one of claims 1-8, characterized in that, A connection hole is further provided at a position near the center of the connecting part. The chordae tendineae part is connected to the connecting part through the connection hole; 10. The self-expanding atrioventricular valve prosthesis device according to claim 9, characterized in that, The circumferential direction of the connection hole is covered with a protective layer to buffer the pulling force generated by the chordae tendineae part on the connecting part; 11. The self-expanding atrioventricular valve prosthesis device according to any one of claims 1-8 or claim 10, characterized in that, It further includes at least one clamping part for realizing the connection function; 12. The self-expanding atrioventricular valve prosthesis device according to claim 11, wherein, When the number of the artificial valve leaflets is configured to be at least two, the clamping part is clamped on the artificial valve leaflets for connecting two adjacent artificial valve leaflets to reduce the movement range of the artificial valve leaflets; 13. The self-expanding atrioventricular valve prosthetic device according to any one of claims 1-8 or claim 10 or 12, characterized in that, The connecting part can be selectively integrally prepared with the artificial valve leaflet and / or the chordae tendineae part, or the artificial valve leaflet, the connecting part and the chordae tendineae part are respectively prepared and then connected.

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