A prosthetic heart valve

Abstract

The present invention discloses a prosthetic heart valve comprising at least two valve components, a sealant covering the valve components, and an edge-sealing structure. A space is formed between the valve components covered with the sealant. The edge-sealing structure has a closed end face and connects the ends of the sealant to form a closed space within the space. The prosthetic heart valve provided by the present invention can reduce the risk of thrombosis between the valve components. Because the edge-sealing structure is flexible, it has little effect on the compression and gripping of the prosthetic valve, and the addition of the edge-sealing structure does not affect the normal function of the prosthetic valve.

Description

Technical Field

[0001] The present invention relates to an interventional medical prosthesis, in particular to a prosthetic heart valve. Background Art

[0002] Heart valves are membranous structures that open and close inside organs in humans and certain animals. Every heart has four valves: the aortic valve, which connects the left ventricle to the aorta; the pulmonary valve, which connects the right ventricle to the pulmonary artery; the mitral valve, which connects the left atrium to the left ventricle; and the tricuspid valve, which connects the right atrium to the right ventricle. These valves act as one-way valves, preventing blood from flowing in one direction but not in the opposite direction.

[0003] With socioeconomic development and an aging population, valvular heart disease (CVD) in the elderly, as well as valvular lesions caused by coronary heart disease and myocardial infarction, is becoming increasingly common. Studies have shown that over 13.3% of people aged 75 and over suffer from varying degrees of valvular heart disease. Valvular heart disease has gradually become a major threat to human health.

[0004] For patients who are elderly, have multiple organ diseases, have a history of open-chest surgery, or have poor cardiac function, surgical procedures carry high risks and mortality rates, and some patients even lose the opportunity for surgery. Transcatheter valve implantation or repair, on the other hand, has the advantages of not requiring a thoracotomy, minimal trauma, and rapid patient recovery. The structures of native heart valves vary, and the anatomical structures and pathological requirements that valve prostheses must address during interventional treatment are also different. Accordingly, the structural design of prosthetic valves is also different.

[0005] According to the number of valve stent layers, existing prosthetic valves can be roughly divided into single-layer valves and multi-layer valves. Multi-layer valves are composed of at least two layers of single-layer valves with different shapes and functions. Multi-layer valves can be divided into two categories: local multi-layer and overall multi-layer. In terms of anchoring, sealing and other functions, multi-layer valves have incomparable advantages over single-layer valves. However, studies have shown that due to the different shapes of the various components of multi-layer valves, space gaps of various shapes and sizes often form between different components. When a multi-layer prosthetic valve is implanted in the heart, some of the space gaps are very prone to blood accumulation and thrombus formation, especially the gaps between the layers of stents at the left atrial end.

[0006] For example, in a prosthetic valve composed of two valve components, the outer layer of the prosthetic valve contacts the native heart tissue and is covered with a sealing member, such as a skirt, that seals the gap between the outer layer and the native heart tissue, preventing blood from flowing out of the gap. The inner layer of the prosthetic valve, which contains prosthetic leaflets that function as a one-way valve, is also covered with a skirt and other sealing members, ensuring a single, one-way flow of blood through the prosthetic leaflets. However, there is a gap between the skirt on the inner and outer layers of the prosthetic valve, where blood can easily accumulate, potentially forming a thrombus. Summary of the Invention

[0007] The technical problem to be solved by the present invention is to provide a prosthetic heart valve that can seal the gap between two adjacent valve components where blood is likely to accumulate, thereby avoiding the formation of thrombus.

[0008] The technical solution adopted by the present invention to solve the above-mentioned technical problems is to provide a prosthetic heart valve, which includes at least two valve components, a seal covered on the valve components, and an edge sealing structure. A space gap is formed between the valve components covered with the seal, and the end face of the edge sealing structure is closed and connected to the end of the seal so that the space gap forms a closed space.

[0009] Preferably, at least one of the valve components is provided with a prosthetic leaflet.

[0010] Preferably, the sealing member is a skirt.

[0011] Preferably, the edge sealing structure is a single-layer edge sealing structure, a double-layer edge sealing structure, or a double-layer edge sealing structure and a single-layer edge sealing structure connected at intervals.

[0012] Preferably, the single-layer edge sealing structure consists of a skirt.

[0013] Preferably, the double-layer edge sealing structure consists of a supporting structure and a skirt attached to the supporting structure.

[0014] Preferably, the support structure is a mesh structure, and is formed by the end of one of the valve components extending toward the end of the other valve component, or by the two valve components extending toward each other.

[0015] Preferably, the support structure and the valve component are connected by riveting, welding or suturing.

[0016] Preferably, the support structure and the valve component are cut and formed integrally.

[0017] Preferably, the prosthetic heart valve includes a first valve component and a second valve component, the first valve component has an inflow channel and an outflow channel in the axial direction, one end of the second valve component is circumferentially connected to the outside of the first valve component, and the other end of the second valve component is a free end, and the sealing structure connects the end of the seal near the free end of the second valve component and the end of the seal on the inflow channel of the first valve component, so that the spatial gap between the first valve component and the second valve component forms a closed space.

[0018] Preferably, the end surface of the edge sealing structure is horizontal or inclined toward the outflow channel of the first valve component.

[0019] Preferably, the end of the seal close to the free end of the second valve component is higher than the end of the seal on the inflow channel of the first valve component, and the end surface of the edge sealing structure is a plane.

[0020] Preferably, the end of the seal near the free end of the first valve component is lower than or equal to the height of the end of the seal on the inflow channel of the first valve component, the end face of the edge sealing structure is a curved surface, the end face of the edge sealing structure near the second valve component is raised upward to form an arc surface, and the end face of the edge sealing structure near the inflow channel of the first valve component is a plane.

[0021] Preferably, a penetrating structure is provided between the first valve component and the second valve component, the penetrating structure penetrates the end surface of the edge sealing structure, and the contact portion between the edge sealing structure and the penetrating structure is sealed.

[0022] Preferably, the first valve component is a stent body, and the second valve component is a flange or an outer stent.

[0023] Compared with the prior art, the present invention has the following beneficial effects: the prosthetic heart valve provided by the present invention adopts the edge sealing structure of the present technical solution on the two valve structures, so that the space gap between the seals on the two valve components forms a closed space, which can greatly reduce the risk of thrombosis between different valve structures of the prosthetic heart valve; because the edge sealing structure is flexible, the edge sealing structure has basically no effect on the compression and grip of the prosthetic valve, and at the same time, the addition of the edge sealing structure will not affect the normal function of the prosthetic heart valve. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 FIG is a schematic diagram of a partial structure of a mitral valve prosthesis without an edge sealing structure according to an embodiment of the present invention, wherein Figure 1 (a) is a three-dimensional image of a partial mitral valve prosthesis. Figure 1 (b) is a side view of the partial mitral valve prosthesis;

[0025] FIG2(a) and FIG2(b) are schematic diagrams of a partial structure of a mitral valve prosthesis with an edge-sealed structure according to an embodiment of the present invention, wherein FIG2(a) is a perspective view of the partial prosthetic heart valve, and FIG2(b) is a side view of the partial prosthetic heart valve;

[0026] Figure 3 FIG is a schematic structural diagram of a mitral valve prosthesis according to the first embodiment of the present invention, wherein Figure 3 (a) is a mitral valve prosthesis without edge sealing structure. Figure 3 (b), 3(c), and 3(d) are mitral valve prostheses with edge-sealing structures;

[0027] Figure 4 FIG is a schematic structural diagram of a mitral valve prosthesis according to a second embodiment of the present invention, wherein Figure 4 (a) is a mitral valve prosthesis without edge sealing structure. Figure 4 (b), 4(c), and 4(d) are mitral valve prostheses with edge-sealing structures;

[0028] Figure 5 FIG is a schematic diagram of a partial structure of a mitral valve prosthesis according to a second embodiment of the present invention, wherein Figure 5 (a) is a schematic diagram of the local structure of a mitral valve prosthesis without an edge-sealing structure. Figure 5 (b), 5(c), 5(d), and 5(e) are schematic diagrams of the local structures of mitral valve prostheses with sealing edge structures in different directions;

[0029] Figure 6 FIG is a schematic diagram of a partial structure of a mitral valve prosthesis in a second embodiment of the present invention, wherein Figure 6 (a) is a schematic diagram of the local structure of a mitral valve prosthesis without an edge-sealing structure. Figure 6 (b) and 6(c) are schematic diagrams of the local structures of mitral valve prostheses with sealing structures of different orientations;

[0030] Figure 7 FIG is a schematic diagram of a partial structure of a mitral valve prosthesis in a second embodiment of the present invention, wherein Figure 7 (a) is a schematic diagram of the local structure of a mitral valve prosthesis without an edge-sealing structure. Figure 7 (b) and 7(c) are schematic diagrams of the local structures of mitral valve prostheses with sealing structures of different orientations;

[0031] Figure 8 FIG is a schematic structural diagram of a mitral valve prosthesis according to a third embodiment of the present invention, wherein Figure 8 (a) is a mitral valve prosthesis without edge sealing structure. Figure 8 (b), 8(c), and 8(d) are mitral valve prostheses with edge-sealing structures;

[0032] Figure 9 Schematic diagram of the structure of a mitral valve prosthesis according to a fourth embodiment of the present invention;

[0033] Figure 10 This is a schematic structural diagram of a prosthetic heart valve placed in a delivery tube in an embodiment of the present invention.

[0034] Note: For easy observation, Figure 3 、 Figure 4 、 Figure 8 The prosthetic valves shown are all with attached skirts on the left and bare stents on the right. Except for the thin solid lines used in the annotations, all other thin solid lines represent stent rods or metal rods. Except for the thick solid lines used in the annotations, all other thick solid lines represent skirts. All thin dashed lines represent artificial valve leaflets. Figure 5 、 Figure 6 、 Figure 7 、 Figure 9 、 Figure 10 The medium-thick solid lines all represent edge-sealed structures.

[0035] In the picture:

[0036] 110 flange 120 barb 130 bracket body 140 edge sealing structure 150 outer bracket

[0037] 160 special-shaped flange 170 hook 180 through structure 131 inflow channel 132 outflow channel

[0038] 1301 inlet channel end 1401 edge sealing structure end face

[0039] 141 support structure 1601 special-shaped flange free end DETAILED DESCRIPTION

[0040] In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. However, it will be apparent to one of ordinary skill in the art that the present invention can be practiced without these specific details. Therefore, the specific details set forth are merely exemplary, and the specific details may be varied within the spirit and scope of the present invention and still be considered to be within the spirit and scope of the present invention.

[0041] The present invention describes embodiments of a prosthetic heart valve that is primarily intended for implantation in the mitral valve region of the human heart. The prosthetic valve can be used to help repair or replace the function of a defective native mitral valve. However, while the present invention primarily focuses on the mitral valve, the concept is not limited to the mitral valve and can be used with prosthetic valves in other areas of the heart or body, such as the tricuspid valve. The following uses a mitral prosthetic heart valve as an example:

[0042] Due to the anatomical large size of the mitral valve annulus, the part of the support body of the prosthetic heart valve implanted in the mitral valve that is used to carry the artificial valve leaflets needs to be larger in both circumferential diameter and axial height. As a result, after the prosthetic valve is implanted in the mitral valve, the prosthetic structure under the valve is larger in size, and there is a greater risk of damage to the subvalvular structure of the native valve assembly. At the same time, if the prosthetic structure under the valve is too large, it will affect the ejection function of the aorta and cause obstruction of the left ventricular outflow tract. For some patients with mitral regurgitation, there is no calcification on their valve, and the existing working principle of using the radial support force generated between the prosthetic valve and the native valve to prevent the displacement of the prosthetic valve cannot be used. Therefore, the therapeutic effect of the traditional single-layer mitral valve prosthetic valve is not ideal.

[0043] For mitral valve prostheses with multiple valve components, the functions of supporting the artificial leaflets and performing anchoring and sealing can be distributed to different valve components, thereby achieving the goal of not affecting the normal operation of other heart structures while better performing the implanted therapeutic function. However, studies have shown that due to the different shapes of the various valve components, gaps of varying shapes and sizes often form between the seals on different valve components. When a prosthetic valve with multiple valve components is implanted in the heart, some of these gaps are prone to blood accumulation and thrombosis, especially the gaps between the valve components at the left atrial end.

[0044] Therefore, see Figure 1 2(a) and 2(b), the prosthetic heart valve provided in this embodiment includes at least two valve components, the outer prosthetic valve is in contact with the native heart tissue, and a sealing member, such as a skirt, is coated on its surface. The sealing member has the function of sealing the gap between the outer prosthetic valve and the native heart tissue, thereby preventing blood from flowing out of the gap between the two. The inner prosthetic valve includes prosthetic leaflets that function as a one-way valve. The inner valve is also coated with a skirt and other sealing members, thereby ensuring the only channel for one-way flow of blood in the prosthetic leaflets. The sealing components in this embodiment are all based on skirts as an example. A space gap that can cause blood accumulation is formed between the skirts on the two valve components. The two valve components can be the stent body 130 and the flange 110, or they can be other valve components. The prosthetic heart valve is provided with a sealing structure 140. The end face 1401 of the sealing structure 140 is closed. The sealing structure 140 covers the end parts of the skirts on the two valve components, or the sealing structure 140 is connected to the end parts of the skirts on the two valve components, so that the sealing structure 140 can at least close the end face of the space gap formed between the skirts on the two valve components; that is, the open end facing the blood flow direction formed between the two valve components is closed, so that the space gap forms a closed space. No matter from which direction the blood flows to the stent body 130, it will not cause blood accumulation and form a thrombus.

[0045] The edge sealing structure 140 can be a single-layer edge sealing structure, a double-layer edge sealing structure, or a double-layer edge sealing structure and a single-layer edge sealing structure connected in intervals. The single-layer edge sealing structure is composed of a skirt, preferably, the skirt is tightly connected to the ends of the skirts on the two valve components. References in the present invention to the edge sealing structure 140 being connected to the ends of the sealing elements on the valve components, or similar expressions, include the situation where the edge sealing structure 140 covers the ends of the skirts on the two valve components.

[0046] There are two possible orders for assembling the edge sealing structure 140 onto the prosthetic heart valve stent:

[0047] 1. First, install the skirt on the bare bracket, and then install the edge sealing structure 140 on the bracket with the skirt;

[0048] 2. The skirt and the edge sealing structure 140 are installed integrally on the bare bracket at the same time.

[0049] In one embodiment, the edge sealing structure 140 is formed by a skirt, such as Figure 3 As shown in (d), 4(d), and 8(d), the skirt, after being tightened, covers or connects the skirt ends of the two valve components, thereby sealing the space between the two valve components. The skirt is made of a polymer material such as PET (polyethylene terephthalate) or PTFE (polytetrafluoroethylene), or animal pericardial tissue, and covers the outer surface of the valve component where the space needs to be sealed to prevent blood leakage and achieve a sealing effect.

[0050] In another embodiment, the edge sealing structure 140 is formed into a double-layer edge sealing structure by the support structure 141 and the skirt. Figure 3 (b), 4(b), and 8(b). Specifically, a support structure 141 having a certain degree of rigidity is used to connect the two valve components. The connection between the support structure 141 and the valve components is located at or above the end of the skirt. A skirt is then attached to the surface of the support structure 141. The skirt attached to the support structure 141 covers or connects to the end of the skirt on the valve component. The support structure is a mesh structure formed by first covering it with a structure similar to a stent grid and then sewing the skirt. Preferably, the support structure 141 is a mesh structure, formed by extending the end of one of the two valve components toward the end of the other valve component, or by extending the two valve components toward each other.

[0051] The support structure 141 can be cut into a mesh structure from a metal having shape memory effects, such as nickel-titanium alloy, and then manufactured by heat treatment and other processing techniques. The support structure 141 can also be woven from metal wires such as nickel-titanium wire. The support structure 141 can also be partially cut from metals having shape memory effects such as nickel-titanium, and then manufactured by heat treatment and other processing techniques, and partially composed of a combination of woven structures of metal wires such as nickel-titanium wire. The mesh shape of the support structure 141 can be circular, diamond-shaped, or teardrop-shaped, and can be the same as or different from the mesh shape of the valve component.

[0052] The support structure 141 and the valve components can be connected by riveting, welding, suturing, etc. When both the support structure 141 and the valve components are cut and manufactured from a memory alloy, the support structure 141 can also be cut and formed integrally with the valve components, and then produced into the final form through a process such as heat treatment, folding, and shaping.

[0053] In another embodiment, the edge sealing structure 140 is formed by attaching the skirt support structure 141 and the separate skirt spacers, such as Figure 3 (c), 4(c), and 8(c). The edge sealing structure 140 is divided into two or more sections, each of which is manufactured using a different processing method and then connected to form a complete edge sealing structure. For example, the edge sealing structure 140 is divided into three sections: the first section is formed by braiding metal wire and then attaching a skirt, the second section is composed of only the skirt, and the third section is cut and formed integrally with the valve stent and then attached to the skirt. Finally, the three sections are connected by various suitable methods such as suturing and adhesion to form the final edge sealing structure.

[0054] Edge sealing structure 140 is applicable to a wide range of prosthetic valve types. It can be used to seal any gaps where blood could potentially accumulate, preventing the formation of thrombi. Regardless of the anchoring and sealing mechanism employed in a prosthetic valve stent, any gaps prone to blood accumulation can be sealed using various edge sealing structures. This means that different stent designs can influence the design of the edge sealing structure. The present invention will be further illustrated below using several embodiments. However, this invention is not limited to the following types of prosthetic valves and applications.

[0055] Example 1

[0056] Figure 3(a) shows a schematic diagram of the partial structure of a mitral valve prosthesis, comprising a stent body 130 and a flange 110. The stent body 130 has an inflow channel 131 and an outflow channel 132 in the axial direction. The outflow channel 132 is located downstream of the inflow channel 131 in terms of the direction of blood flow. The inflow channel 131 corresponds to the portion of the prosthetic valve where blood flows into the prosthesis during operation, while the outflow channel 132 corresponds to the portion of the prosthesis where blood flows out of the prosthesis during operation of the human valve. The solid black arrows in the accompanying drawings indicate the direction of blood flow. In this embodiment, the two valve components are the stent body 130 and the flange 110. One end of the flange 110 is circumferentially connected to the outside of the inflow channel 131 of the stent body 130, while the other end of the flange 110 is free. The prosthetic valve is anchored by the flange 110 and the barbs 120. The stent body 130 supports the artificial valve leaflets and has a certain radial dimension to fit the native mitral valve leaflets of the heart to provide a seal. Because part of the structure of the stent body 130 is appropriately exposed at the left atrial end, the size of the prosthetic valve in the left ventricle is reduced, thereby alleviating the adverse effects of a larger prosthetic valve implanted in the mitral valve.

[0057] Please continue to refer to Figure 3 (a) A sealing skirt is provided from the free end of the flange 110 to the connection between the flange 110 and the stent body 130, and to the end of the stent inflow channel. When blood flows in the direction indicated by the arrow, the gap area ① between the flange 110 and the stent body 130 is very likely to accumulate blood and form a thrombus; please refer to Figure 3 As shown in (b)(c)(d), the edge sealing structure 140 connects the skirt at the free end of the flange 110 and the skirt at the inflow channel end 1301 of the stent body 130, so that the edge sealing structure 140 seals the space gap ① formed between the proximal end of the stent body 130 and the flange 110, thereby preventing blood from accumulating.

[0058] Example 2

[0059] Figure 4(a) shows a schematic diagram of a partial structure of a mitral valve prosthesis. The prosthetic valve comprises a shaped flange 160 and a stent body 130. The stent body 130 has an inflow channel 131 and an outflow channel 132 axially. With respect to the direction of blood flow, the outflow channel 132 is located downstream of the inflow channel 131. The inflow channel 131 corresponds to the portion of the prosthetic valve where blood flows into the prosthesis during operation, while the outflow channel 132 corresponds to the portion of the prosthesis where blood flows out of the prosthesis during operation of a human valve. The solid black arrows in the figure indicate the direction of blood flow. Unlike Example 1, the flange in this embodiment is a special-shaped flange 160. Specifically, the two valve components in this embodiment are the stent body 130 and the special-shaped flange 160. One end of the special-shaped flange 160 is fixedly connected to the outside of the outflow passage 132 of the stent body 130, while the other end of the special-shaped flange 160 is free. The prosthetic valve is anchored by the special-shaped flange 160 and the hook 170. The stent body 130 supports the artificial valve leaflets, and the special-shaped flange 160 also provides a certain support force to fit the native mitral valve leaflets and perform a sealing function. Since the stent body 130 only needs to support the artificial valve leaflets, it does not need large radial and axial dimensions, thereby reducing the adverse effects of a large prosthetic valve implanted in the mitral valve.

[0060] Please continue to refer to Figure 4 (a) The flange free end 1601 extends to the connection between the flange and the main body, and extends to the end 1301 of the stent inlet channel, all of which are covered with a sealing skirt. When blood flows in the direction indicated by the arrow, the gap area ① between the special-shaped flange 160 and the stent main body 130 is very likely to accumulate blood and form a thrombus; please refer to Figure 4 As shown in (b)(c) and (d), the edge sealing structure 140 connects or covers the skirt of the free end 1601 of the special-shaped flange and the skirt of the inflow channel end 1301 of the stent body 130, closing the gap area ① formed between the stent body 130 and the special-shaped flange 160, thereby preventing blood from accumulating.

[0061] All embodiments define the inflow channel as being located at the top and the outflow channel as being located at the bottom, and the axis of the bracket body 130 is perpendicular to the horizontal plane when placed. When the height of the free end 1601 of the special-shaped flange is lower than the end 1301 of the bracket body inflow channel, the edge sealing structure 140 has four main orientation designs, namely:

[0062] like Figure 5 As shown in (b), the end face 1401 of the edge sealing structure connects or covers the free end 1601 of the special-shaped flange and the skirt of the inlet channel end 1301 in a plane form (the corresponding cross-sectional view is a straight line), and the end face 1401 of the edge sealing structure is inclined toward the free end 1601 of the special-shaped flange.

[0063] like Figure 5As shown in (c), without affecting the structural function of the bracket, the end face 1401 of the edge sealing structure is connected or covers the skirt of the free end 1601 of the special-shaped flange and the end 1301 of the inflow channel in the form of a curved surface (the corresponding cross-sectional view is a curve), the end face of the edge sealing structure close to the free end 1601 of the special-shaped flange is upwardly convex and forms an arc surface, and the end face of the edge sealing structure close to the end 1301 of the inflow channel of the bracket body is a horizontal surface.

[0064] like Figure 5 As shown in (d), without affecting the structural function of the bracket, the end face 1401 of the edge sealing structure is connected or covers the free end 1601 of the special-shaped flange and the end 1301 of the inlet channel in the form of a curved surface (the corresponding cross-sectional view is a curve), the end face of the edge sealing structure close to the free end 1601 of the special-shaped flange is upwardly convex and forms an arc surface, and the end face of the edge sealing structure close to the end 1301 of the inlet channel of the bracket main body is a plane inclined toward the end 1301 of the inlet channel of the bracket main body.

[0065] like Figure 5 As shown in Figure (e), the shaped flange 160 is covered with a skirt from the connection with the stent body 130 to the free end 1601. The portion of the stent body 130 near the inflow channel end 1301 is not covered with a skirt. The edge sealing structure 140 connects the flange free end 1601 with the portion near the inflow channel end 1301 of the stent body. The connection between the edge sealing structure 140 and the stent body 130 is located above the connection point between the shaped flange 160 and the stent body 130 and below the inflow channel end 1301, so that the end surface 1401 of the edge sealing structure is horizontal or tilted from the flange free end 1601 toward the stent body outflow channel. The portion of the stent body inflow channel above the edge sealing structure 140 is not covered with a skirt, ensuring that blood can flow smoothly from the edge sealing structure 140 into the leaflet channels of the stent body 130.

[0066] When the free end 1601 of the special-shaped flange is substantially flush with the end 1301 of the inflow channel of the bracket body, the edge sealing structure 140 has two main orientation designs, namely:

[0067] like Figure 6 As shown in (b), the edge sealing structure end surface 1401 connects or covers the free end 1601 of the special-shaped flange and the skirt of the inlet channel end 1301 in a plane form (the corresponding cross-sectional view is a straight line), and the edge sealing structure end surface 1401 is perpendicular to the axis of the bracket.

[0068] like Figure 6As shown in (c), without affecting the structural function of the bracket, the end face 1401 of the edge sealing structure is connected or covered with the skirt of the free end 1601 of the special-shaped flange and the inlet channel end 1301 in the form of a curved surface (the corresponding cross-sectional view is a curve), that is, the end face of the edge sealing structure close to the free end 1601 of the special-shaped flange is upwardly convex and forms an arc surface, and the end face of the edge sealing structure close to the inlet channel end 1301 of the bracket main body is a plane inclined toward the branch inlet channel end 1301.

[0069] When the free end 1601 of the special-shaped flange is higher than the left atrial end 1301 of the stent body, the edge sealing structure 140 has two main orientation designs, namely:

[0070] like Figure 7 As shown in (b), the edge sealing structure end face 1401 connects or covers the free end 1601 of the special-shaped flange and the skirt of the inlet channel end 1301 in a plane form (the corresponding cross-sectional view is a straight line form), and the edge sealing structure end face 1401 is inclined toward the inlet channel end 1301 of the bracket body.

[0071] like Figure 7 As shown in (c), the edge sealing structure 140 can be appropriately connected to the lower side of the free end 1601 of the special-shaped flange, but at least the end face 1401 of the edge sealing structure must be perpendicular to the axis of the bracket. In this embodiment, the special-shaped flange portion located above the edge sealing structure 140 no longer covers the skirt.

[0072] The above edge banding structure design is optimized Figure 5 d. Figure 6 c. Figure 7 The design shown in b, i.e. the sealing structure end face 1401 is more suitable for use: after being sealed, the sealing structure end face 1401 is inclined toward the inflow channel end 1301 of the stent body, which is better for blood to flow toward the prosthetic valve stent body and is beneficial to the circulation of blood between the left atrium and the chamber.

[0073] Example 3

[0074] Figure 8Figure (a) shows a mitral valve prosthesis. In this embodiment, the prosthetic valve comprises an outer stent 150 and a stent body 130 disposed within the outer stent 150. Stent body 130 axially defines an inflow channel 131 and an outflow channel 132. With respect to blood flow, outflow channel 132 is located downstream of inflow channel 131. Inflow channel 131 corresponds to the portion of the prosthetic valve where blood flows into the valve during operation, while outflow channel 132 corresponds to the portion of the prosthetic valve where blood flows out of the valve during operation. The solid black arrows in the figure indicate the primary direction of blood flow. In this embodiment, the two valve components are the stent body 130 and the outer stent 150. One end of the outer stent 150 is circumferentially fixedly connected to the outside of the stent body 130, while the other end of the outer stent 150 is free. The outer stent 150 and the barbs 120 anchor the prosthetic valve. The stent body 130 supports the artificial valve leaflets, and the outer stent 150 also provides a certain support force to fit the native mitral valve leaflets and act as a seal. Because the stent body 130 only needs to support the artificial valve leaflets, it does not require large radial and axial dimensions, thereby reducing the adverse effects of a larger prosthetic valve implanted in the mitral valve. However, when blood flows in the direction indicated by the arrow, the gap area ① between the outer stent 150 and the skirt of the stent body 130 is very likely to accumulate blood, forming a thrombus.

[0075] like Figure 8 As shown in (b)(c)(d), the edge sealing structure 140 connects or covers the skirt of the free end of the outer layer stent 150 and the skirt of the inflow channel end 1301 of the stent body 130, closing the gap area ① formed between the stent body 130 and the outer layer stent 150, thereby preventing blood from accumulating.

[0076] Example 4

[0077] Figure 9 The partial structure of a mitral valve prosthesis is shown. The prosthetic valve comprises a shaped flange 160 and a stent body 130. One end of the shaped flange 160 is fixedly connected to the outside of the stent body 130, while the other end is free. The prosthetic valve is anchored by the shaped flange 160 and a hook 170. The stent body 130 has an inflow channel 131 and an outflow channel 132 in the axial direction. The stent body 130 supports the artificial valve leaflets. The shaped flange 160 also provides a certain support force to fit the native mitral valve leaflets and act as a seal. Because the stent body 130 only needs to support the artificial valve leaflets, it does not require large radial and axial dimensions, thereby reducing the adverse effects of a larger prosthetic valve implanted in the mitral valve. A through-structure 180 (or other structures that need to protrude into the space, depending on the innovative design of the stent itself) is also present between the shaped flange 160 and the stent body 130.

[0078] A vacant structure that seals with the through structure 180 can be designed in the area corresponding to the edge sealing structure end surface 1401, so that the through structure 180 extends and penetrates the edge sealing structure end surface 1401 to achieve a sealing effect.

[0079] like Figure 10 As shown, when the prosthetic valve is squeezed and shrunk and placed into the delivery tube 200, the edge sealing structure 140 is also squeezed together. Since the sealing device is made flexibly, that is, the edge sealing structure 140 adopts a skirt, a mesh support structure or a part of a skirt and a part of a support structure, and the materials used for the skirt and the support structure are flexible, the sealing device has basically no effect on the squeezing of the prosthetic valve.

[0080] Although the present invention has been disclosed above with reference to preferred embodiments, it is not intended to limit the present invention. Any person skilled in the art may make some modifications and improvements without departing from the spirit and scope of the present invention. Therefore, the scope of protection of the present invention shall be based on the definition of the claims.

Claims

1. A prosthetic heart valve, characterized in that: It includes a first valve component and a second valve component, a seal covered on the first valve component and the second valve component, and a sealing structure. A space gap is formed between the first valve component and the second valve component covered with the seal. The end face of the sealing structure is closed. The first valve component has an inflow channel and an outflow channel in the axial direction. One end of the second valve component is circumferentially connected to the outside of the first valve component, and the other end of the second valve component is a free end. The sealing structure connects the end of the seal close to the free end of the second valve component and the end of the seal on the inflow channel of the first valve component, so that the space gap between the first valve component and the second valve component forms a closed space.

2. The prosthetic heart valve according to claim 1, wherein The first valve component is provided with a prosthetic valve leaflet.

3. The prosthetic heart valve according to claim 1, wherein: The sealing member is a skirt.

4. The prosthetic heart valve according to claim 1, wherein The edge sealing structure is a single-layer edge sealing structure, a double-layer edge sealing structure, or a double-layer edge sealing structure and a single-layer edge sealing structure connected at intervals.

5. The prosthetic heart valve according to claim 4, wherein: The single-layer edge sealing structure consists of a skirt.

6. The prosthetic heart valve according to claim 4, wherein: The double-layer edge sealing structure consists of a supporting structure and a skirt attached to the supporting structure.

7. The prosthetic heart valve according to claim 6, wherein: The support structure is a mesh structure, and is formed by an end portion of one of the first valve component and the second valve component extending toward an end portion of the other valve component, or by the first valve component and the second valve component extending toward each other.

8. The prosthetic heart valve according to claim 6, wherein: The support structure and the first valve component and the second valve component are connected by riveting, welding or suturing.

9. The prosthetic heart valve according to claim 6, wherein: The support structure, the first valve component, and the second valve component are cut and formed integrally.

10. The prosthetic heart valve according to claim 1, wherein The end surface of the edge sealing structure is horizontal or inclined toward the outflow channel of the first valve component.

11. The prosthetic heart valve according to claim 10, wherein: The end of the seal close to the free end of the second valve component is higher than the end of the seal on the inflow channel of the first valve component, and the end surface of the edge sealing structure is a plane.

12. The prosthetic heart valve according to claim 10, wherein: The end of the seal near the free end of the first valve component is lower than or equal to the height of the end of the seal on the inflow channel of the first valve component. The end face of the edge sealing structure is a curved surface. The end face of the edge sealing structure near the second valve component is raised upward to form an arc surface. The end face of the edge sealing structure near the inflow channel of the first valve component is a flat surface.

13. The prosthetic heart valve according to claim 1, wherein A penetrating structure is provided between the first valve component and the second valve component. The penetrating structure penetrates the end surface of the edge sealing structure, and the contact portion between the edge sealing structure and the penetrating structure is sealed.

14. The prosthetic heart valve according to claim 1, wherein The first valve component is a stent body, and the second valve component is a flange or an outer stent.

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