A valve stent and an artificial heart valve comprising the valve stent

Abstract

This invention discloses a valve stent, comprising a stent assembly including at least two stents: an inner stent and an outer stent. The inner and outer stents are nested. The stent assembly is configured to have at least one sheath end group, including a first sheath end and a second sheath end, the second sheath end being located outside the first sheath end. In the at least one sheath end group, the length of the first sheath end is greater than the length of the second sheath end. The sheath end group is provided with a protrusion to prevent the sheath end group from interfering with the loading of the valve prosthesis. This invention also provides an artificial heart valve. The valve stent of this invention, with its protrusion, can prevent the second sheath end of the outer stent from contacting the sheath end, thereby affecting loading and reducing loading resistance and the risk of sheath ingress into the dissection.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a valve stent and an artificial heart valve implanted in the heart. Background Art

[0002] Heart valves are membranous structures in the organs of humans and some animals that can open and close. Each person has four valves in their heart: the aortic valve (connecting the left ventricle and aorta), the pulmonary valve (connecting the right ventricle and pulmonary artery), the mitral valve (connecting the left atrium and left ventricle), and the tricuspid valve (connecting the right atrium and right ventricle). They all act as one-way valves, ensuring that blood flows only in one direction and not backwards.

[0003] Mitral regurgitation can lead to myocardial remodeling, progressive ventricular enlargement, and ultimately heart failure. Transcatheter mitral valve replacement (TMVR) uses a catheter to deliver an artificial valve via an external delivery system to the mitral valve annulus, where it is then released and fixed to replace the native valve. Compared to traditional surgery, TMVR does not require cardiopulmonary bypass, is less invasive, allows for faster patient recovery, and significantly improves postoperative hemodynamic parameters.

[0004] For some patients with mitral regurgitation, the implantation of traditional single-layer mitral valve prostheses is not ideal. Multilayer mitral valve prostheses, however, distribute the functions of supporting the artificial leaflet and providing anchoring and sealing to different single-layer valve components, thus achieving the goal of not affecting the normal functioning of other cardiac structures while effectively fulfilling the therapeutic purpose of implantation.

[0005] The installation of multi-layered support structures often encounters difficulties; see [link / reference]. Figure 11 , Figure 12 This is a double-layered stent structure. When the length of the inner stent's insertion end is greater than that of the outer stent, a gradient is formed between the inner and outer stents at the insertion end faces. During loading, the end face of the outer stent will encounter the end face of the sheath, causing them to abut each other. This contact hinders the entire valve from entering the sheath, resulting in high loading resistance. The outer stent is also prone to damaging the sheath, posing a risk of the sheath entering the space between the two stent layers. Furthermore, if retrieval and release are required during implantation, the high resistance at this end will also affect successful retrieval. Summary of the Invention

[0006] This invention provides a valve stent that eliminates the gradient at the insertion end face between the two stent layers, preventing the end of the outer stent from touching the end of the sheath tube and thus affecting the stent's entry into the sheath tube, reducing loading resistance and the risk of the sheath tube entering the interlaminar space.

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

[0008] A valve stent includes a stent assembly comprising at least two stents, an inner stent and an outer stent, wherein the inner stent and the outer stent are nested together, the inner stent being sleeved inside the outer stent, and the stent assembly is configured to have at least one insertion sheath end group.

[0009] The sheath end assembly includes a first sheath end and a second sheath end. The first sheath end is located on the inner support layer, and the second sheath end is located on the outer support layer. The first and second sheath ends extend in the same direction, and the second sheath end is located outside the first sheath end. When the length of the first sheath end is greater than the length of the second sheath end in at least one of the sheath end assemblies, the sheath end assembly is provided with a protrusion to prevent the sheath end assembly from interfering with the loading of the valve prosthesis.

[0010] Because of the gradient difference between the first and second insertion ends, when the valve prosthesis is pressed into the sheath, the end face of the second insertion end will encounter the end face of the delivery system, such as the sheath tube. This contact between the two end faces results in high loading resistance, affecting the entire valve prosthesis's entry into the sheath tube. Furthermore, the second insertion end is prone to damaging the sheath tube, and there is also a risk of the sheath tube entering the interstitial space between the inner and outer stents. The protrusion eliminates the interference caused by the insertion end assembly on the valve prosthesis loading, reducing the risk of the sheath tube entering the interstitial space between the inner and outer stents during loading, as well as the risk of the end face of the second insertion end contacting the sheath tube.

[0011] One end of the valve prosthesis enters the delivery system first; this first entry end is the sheath insertion end. The first sheath insertion end can be a lug located on the inner stent, and the stent assembly is connected to the delivery system via the lug. The specific structure and function of the first and second sheath insertion ends are not intended to limit the scope of protection of this invention.

[0012] Depending on the delivery system structure and release method, the valve prosthesis can be inserted into the sheath at one end first, such as the ventricular end first or the atrial end first. When the delivery system, such as the sheath, has a two-section structure, the atrial and ventricular ends of the stent assembly are simultaneously used as insertion ends and loaded into the delivery system.

[0013] Preferably, the stent assembly includes multiple sheath end groups, each located at the atrial or ventricular end. These multiple sheath end groups ensure stable loading of the valve prosthesis into the delivery system. The multiple sheath end groups can be simultaneously located at the atrial end, simultaneously located at the ventricular end, or respectively located at both the atrial and ventricular ends. In each sheath end group, when the length of the first sheath end is greater than the length of the second sheath end, each sheath end group is provided with a protrusion. Each protrusion can eliminate interference from each sheath end group during the insertion process.

[0014] Preferably, the protrusion is located at the first sheath end, and the protrusion has a first end face located on the side of the end face near the second sheath end, the width of the first end face being not less than the width of the second sheath end. In this case, due to the blocking effect of the protrusion, the sheath will not enter the interlayer between the first and second sheath ends, thereby reducing the risk of the sheath entering the interlayer of the inner and outer supports.

[0015] Preferably, the protrusion further has a second end face located on a side opposite to the first end face, and the second end face is flush with the end face of the first sheath insertion end. In this case, the protrusion eliminates the gradient difference between the first and second sheath insertion ends, further reducing the risk of the sheath entering the interlayer of the inner and outer supports. Furthermore, when the length of the first end face of the protrusion is greater than or equal to the width of the second sheath insertion end, the end face of the second sheath insertion end will not touch the end face of the sheath, thereby avoiding the phenomenon of the end face of the second sheath insertion end colliding with the end face of the sheath, reducing loading resistance, and simultaneously preventing the second sheath insertion end from damaging the sheath.

[0016] Preferably, the first end face of the protrusion abuts against the end face of the second sheath insertion end. Due to the abutting action from the protrusion, the sheath tube will not enter the support interlayer from the end of the second sheath insertion end during insertion.

[0017] Preferably, the first end face matches the end face of the second insertion sheath end. Here, matching means that they are the same size and the shapes of the end faces form a concave-convex match. In this way, when the protrusion abuts against the end face of the second insertion sheath end, the insertion sheath end assembly can form a whole insertion sheath, making the loading of the valve prosthesis easier and reducing the risk of damage to the sheath tube by the second insertion sheath end.

[0018] Preferably, the outer contour of the protrusion is arc-shaped. The arc-shaped outer contour reduces friction with the sheath end and the sheath wall, thereby reducing loading resistance.

[0019] Preferably, the protrusion is integrally formed on the first sheath end, which simplifies the forming process and makes the connection between the protrusion and the first sheath end more stable and reliable.

[0020] Preferably, the first sheath end is a lug for connection to the conveying system. When the first sheath end of the inner support is longer, it is preferable to connect to the conveying system through the lug of the inner support, which is more reliable and stable.

[0021] Preferably, the axial contact surfaces of the first insertion sheath end and the second insertion sheath end are configured as a concave-convex mating connection. During valve stent molding, in each insertion sheath end assembly, the first insertion sheath end and the second insertion sheath end are pre-shaped by means of welding or other methods. The concave-convex mating connection can replace the welding connection method and has the advantages of stable connection and ease of implementation.

[0022] An artificial heart valve comprising a valve stent as described in any of the above.

[0023] Compared with the prior art, the present invention has the following beneficial effects:

[0024] First, the protrusion of the present invention eliminates the interference caused by the insertion end assembly to the valve prosthesis loading, reducing the risk of the sheath entering the interstitial space during loading and the risk of the end face of the second insertion end contacting the sheath. When the protrusion is located at the first insertion end and the length of the first end face is not less than the width of the second insertion end, the protrusion can effectively prevent the sheath from entering the interstitial space. When the second end face of the protrusion is flush with the end face of the first insertion end, the protrusion eliminates the gradient difference between the first and second insertion ends. At this time, the end face of the second insertion end will not touch the end face of the sheath, thereby avoiding contact between the end face of the second insertion end and the end face of the sheath, reducing loading resistance and reducing the risk of damaging the sheath.

[0025] Secondly, when the first end face of the protrusion abuts against the end face of the second insertion sheath, and when the first end face matches the end face of the second insertion sheath, the integrity of the insertion sheath assembly is improved, further reducing the risk of damage to the sheath tube by the second insertion sheath, and ensuring the smooth loading, transportation, and release of the valve prosthesis and the smooth retrieval of the sheath tube; when the outer contour of the protrusion is arc-shaped, the arc-shaped outer contour reduces the friction between the sheath tube end and the sheath tube wall, further reducing the loading resistance.

[0026] Of course, any product implementing the present invention does not necessarily need to achieve all of the advantages described above at the same time. Attached Figure Description

[0027] Figure 1 This is a schematic diagram of the support assembly according to Embodiment 1 of the present invention;

[0028] Figure 2 This is a schematic diagram of the inner support structure of Embodiment 1 of the present invention;

[0029] Figure 3 This is a schematic diagram of the outer support structure of Embodiment 1 of the present invention;

[0030] Figure 4 This is a schematic diagram of the sheath insertion end assembly according to Embodiment 1 of the present invention;

[0031] Figure 5 This is a partial structural schematic diagram of the first sheath end in Embodiment 1 of the present invention;

[0032] Figure 6 This is a partial cross-sectional schematic diagram of the valve prosthesis of Embodiment 1 of the present invention;

[0033] Figure 7 This is a partial cross-sectional schematic diagram of the valve prosthesis sheath in Embodiment 1 of the present invention;

[0034] Figure 8 This is a cross-sectional view of the sheath end assembly according to Embodiment 1 of the present invention;

[0035] Figure 9 This is a cross-sectional view of the sheath end assembly in Embodiment 2 of the present invention;

[0036] Figure 10 This is a cross-sectional view of the sheath end assembly in Embodiment 3 of the present invention;

[0037] Figure 11 This is a schematic diagram of the valve stent and its insertion sheath in the prior art of this invention;

[0038] Figure 12 This is a schematic diagram of a portion of the valve prosthesis sheath in the prior art of this invention.

[0039] Reference numerals: Support assembly 100; Inner support 110; Outer support 120; Inflow section 111; Outflow section 113; Transition section 112; First section 121; Second section 122; Third section 123; Sheath end assembly 101; First sheath end 114; Second sheath end 124; Protrusion 200; Sheath tube 410; First end face 201; Second end face 202; End face 1141 of the first sheath end; End face 1241 of the second sheath end. Detailed Implementation

[0040] The present invention provides a valve stent and an artificial heart valve comprising the valve stent.

[0041] The artificial heart valve of the present invention can be implanted in the left ventricular inflow tract to replace the native mitral valve, and can also be used as a tricuspid valve to be implanted in the right ventricular inflow tract.

[0042] The structure of the artificial heart valve of the present invention is described below using the mitral valve as an example. The heart valve is composed of a stent assembly 100, a valve, and a skirt.

[0043] like Figure 1 As shown, the support assembly 100 consists of two parts: an inner support 110 and an outer support 120. The inner support 110 and the outer support 120 have a nested structure, with the inner support 110 nested inside and the outer support 120 nested outside. The inner support 110 and the outer support 120 are connected by riveting, welding, snap-fitting, sewing, or skirting.

[0044] like Figure 2As shown, the inner stent 110 includes an inflow section 111, an outflow section 113, and a transition section 112 located between the two. Optionally, the inner stent 110 also includes a loop. The outflow section 113 is located downstream of the inflow tract according to the direction of blood flow. The loop is connected to the end of the stent inflow section 111 and / or the end of the outflow section 113. The loop is used to connect with the delivery system to ensure that the relative position of the valve prosthesis and the delivery system remains unchanged when the valve is loaded into the delivery system, released from the delivery system, and transported in the body within the delivery system.

[0045] The cross-sectional shape of the inner scaffold 110 can be circular, D-shaped, flower-shaped, or other irregular shapes. The inner scaffold 110 can be made of materials such as nickel-titanium alloy, titanium alloy, cobalt-chromium alloy, MP35n, 316 stainless steel, L605, Phynox / Elgiloy, platinum-chromium, or other biocompatible metals known to those skilled in the art. Optionally, it also includes elastically or plastically deformable materials, such as expandable balloons, or shape memory alloys that respond to temperature changes by transitioning between a contracted delivery state and an expanded deployment state. Preferably, it is manufactured using nickel-titanium alloy tubing with an outer diameter of 4–13 mm, selected according to actual needs after shaping. The inner scaffold 110 can be a mesh structure composed of multiple rows of units, wherein the constituent units are triangular, rhomboid, pentagonal, teardrop-shaped, or other mesh units that can form a closed shape, with a rhomboid structure being preferred.

[0046] like Figure 3 As shown, the outer stent 120 includes a first segment 121, a second segment 122, and a third segment 123. Optionally, the outer stent 120 also includes a fixing ear, which is disposed on any one end or both ends of the outer stent 120. The fixing ear is used to connect with the delivery system to ensure that the relative position of the valve prosthesis and the delivery system remains unchanged during valve loading into the delivery system, valve release from the delivery system, and valve transportation within the body.

[0047] The fixing ear and the hanging ear are both used to ensure that the valve stent is connected to the delivery device when it is fully loaded. Either one or both can be selected according to the release needs. They can be located at any end of the stent, not limited to the outflow section.

[0048] The cross-sectional shape of the outer scaffold 120 can be circular, D-shaped, flower-shaped, or other irregular shapes. The outer scaffold 120 can be made of materials such as nickel-titanium, titanium alloys, cobalt-chromium alloys, MP35n, 316 stainless steel, L605, Phynox / Elgiloy, platinum-chromium, or other biocompatible metals known to those skilled in the art. Optionally, it may also include elastically or plastically deformable materials, such as expandable balloons, or shape memory alloys that respond to temperature changes by transitioning between a contracted delivery state and an expanded deployment state. The outer scaffold 120 can be a mesh structure composed of multiple rows of units, wherein the constituent units are triangular, rhomboid, pentagonal, teardrop-shaped, or other mesh units that can form a closed shape.

[0049] The valve comprises at least two artificial leaflets, made from animal pericardium or other biocompatible polymer materials. One end of each leaflet is stably connected directly or indirectly to the inner scaffold 110, while the other end is a free end. The number of leaflets may be the same as or different from the number of native leaflets. In operation, the artificial leaflets replace the native leaflets to open and close the blood flow.

[0050] The entire inner or outer surface, or both sides of the stent assembly 100, is covered with a skirt to achieve a sealing function, ensuring a single channel for blood flow from the inflow end to the outflow end of the prosthetic valve leaflet. The skirt is made of pericardium or other biocompatible polymer materials (such as PET (polyethylene terephthalate), PTFE (polytetrafluoroethylene), etc.).

[0051] The present invention does not limit the anchoring form of the valve prosthesis. A flange can be set on the stent assembly 100 to adopt an oversized anchoring form. Alternatively, anchoring structures such as spikes and anchor claws can be set on the stent assembly 100 to grasp the original tissue. Or, the prosthesis can be fixed by tying ropes to anchor it to the ventricular wall.

[0052] This invention only illustrates a mitral valve prosthesis, but is not limited to aortic valve prostheses, pulmonary valve prostheses, tricuspid valve prostheses, etc. with similar structures.

[0053] like Figure 11 , Figure 12 As shown, a problem with the existing technology is that when the length of the insertion end of the inner stent assembly 100 is greater than the length of the insertion end of the outer stent 120, a gradient will form between the insertion end faces of the inner and outer stents. During loading, the insertion end face of the outer stent 120 will touch the end face of the sheath, and the two end faces will abut each other, thus affecting the entire valve's entry into the sheath, resulting in high loading resistance, and the insertion end of the outer stent 120 is prone to damaging the sheath. During implantation, if retrieval and release are required, the high retrieval resistance at this end will also affect the smooth retrieval process.

[0054] In addition, when there is a gradient difference between the insertion ends of the inner and outer stents, there is a risk that the sheath may enter the interlayer between the two stents, or even the interlayer between the inner and outer stents.

[0055] Therefore, the present invention provides a valve stent and a valve prosthesis that can solve the above-mentioned problems.

[0056] In the description of this invention, it should be noted that, during the loading process, one or both ends of the valve prosthesis need to be loaded into the delivery system. The end that enters the delivery system first is the "insertion end". The term "insertion end" should be interpreted broadly as the end structure located at the atrial or ventricular end of the valve prosthesis, such as the "hook" or "fixation ear" mentioned above.

[0057] In the description of this invention, it should be noted that "atrial end" refers to the end located within the atrium, and "ventricular end" refers to the end located within the ventricle. As used herein, "heart valve," "valve prosthesis," and "artificial heart valve" have the same meaning.

[0058] In the description of this invention, it should be noted that "outer side" refers to the direction radially outward from the center of the valve prosthesis. As stated herein, "length" refers to the dimension in the axial direction, and "width" refers to the dimension in the radial direction.

[0059] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0060] In the description of the present invention, it should be noted that, unless otherwise expressly specified or limited, the terms "mounted," "connected," and "connected" should be understood in a broad sense. For example, they may refer to fixed, detachable, or integral connections; mechanical or electrical connections; direct or indirect connections through an intermediate medium; and internal communication between two components. Those skilled in the art will understand the specific meanings of the above terms in the present invention based on the specific circumstances.

[0061] As used herein, the singular forms “a,” “an,” and “the” include plural objects unless otherwise expressly indicated. As used herein, the term “or” is generally used to include the meaning of “and / or” unless otherwise expressly indicated.

[0062] The present invention will be further described below with reference to specific embodiments.

[0063] Example 1

[0064] This embodiment provides a valve stent, including a stent assembly 100, see [link to documentation]. Figures 1-8 The support assembly 100 includes two supports: an inner support 110 and an outer support 120. The inner support 110 and the outer support 120 are nested in an inner-outer structure, with the inner support 110 nested inside and the outer support 120 nested outside.

[0065] The support assembly 100 is configured to have at least one sheath end group 101, the at least one sheath end group 101 including a first sheath end 114 and a second sheath end 124, wherein the first sheath end 114 is located in the inner support 110 and the second sheath end 124 is located in the outer support 120, the first sheath end 114 and the second sheath end 124 extend in the same direction, and the second sheath end 124 is located outside the first sheath end 114.

[0066] In at least one sheath end group 101, the length of the first sheath end 114 is greater than the length of the second sheath end 124, wherein at least one of the sheath end groups 101 is provided with at least one protrusion 200 to prevent the sheath end group 101 from interfering with the loading of the valve prosthesis.

[0067] Since the second insertion end 124 is located outside the first insertion end 114, when the length of the first insertion end 114 is greater than the length of the second insertion end 124, that is, there is a gradient difference between the two insertion ends, the end face of the second insertion end 124 on the outside will touch the end face of the sheath 410 when it is inserted. The two end faces abut against each other, resulting in a large loading resistance, which affects the entire valve prosthesis from entering the sheath 410.

[0068] The protrusion 200 can prevent the above situations, including preventing the sheath 410 from entering the gap between the first insertion end 114 and the second insertion end 124, or preventing the end face of the sheath 410 from contacting the end face of the second insertion end 124, thus affecting the insertion of the valve prosthesis.

[0069] In this embodiment, the ventricular end of the valve prosthesis is inserted into the sheath first, i.e., the ventricular end serves as the insertion end. The first insertion end 114 is a lug located at the ventricular end of the inner stent 110. The first insertion end 114 is inserted first, and the lug that is inserted first is fixed to the delivery system, making it more reliable and stable. The second insertion end 124 may not have any function; for example, it could be the endpoint of the outer stent 120. Of course, in other embodiments, the first insertion end 114 or the second insertion end 124 may also be a connecting rod with a predetermined function. The specific structure and function of the first insertion end 114 and the second insertion end 124 are not intended to limit the scope of protection of this invention.

[0070] Further, see Figure 1 To ensure the valve prosthesis is stably fixed within the delivery sheath and to facilitate its smooth release, the ventricular end of the stent assembly 100 is provided with multiple sheath insertion end groups 101. These multiple sheath insertion end groups 101 are evenly distributed circumferentially. When the length of the first sheath insertion end 114 in each of the sheath insertion end groups 101 is greater than the length of the second sheath insertion end 124, each of the sheath insertion end groups 101 is provided with the protrusion 200. This prevents the sheath from entering the interlayer of any sheath insertion end group 101 during insertion and avoids any second sheath insertion end 124 from contacting the end face of the sheath, allowing the valve prosthesis to be smoothly inserted. Of course, in other embodiments, multiple sheath insertion end groups 101 may be simultaneously provided at the atrial end of the stent assembly 100, or multiple sheath insertion end groups 101 may be provided at both the atrial and ventricular ends of the stent assembly 100. The location and number of the sheath end group 101 should be selected according to the actual release method and the structure of the delivery system, which will not be elaborated here.

[0071] See Figure 6 , Figure 8 The end face 1141 of the first sheath insertion end is located at the free end of the first sheath insertion end 1141, and the end face 1241 of the second sheath insertion end is located at the free end of the second sheath insertion end 124.

[0072] In this embodiment, the protrusion 200 is provided at the first sheath end 114. The protrusion 200 has a first end face 201. The first end face 201 is located on the side near the end face 1241 of the second sheath end. The width D1 of the first end face 201 is not less than the width D2 of the second sheath end 124.

[0073] Wherein, the width D1 of the first end face 201 can be equal to the width D2 of the second sheath end 124, such as Figure 6 , Figure 7 As shown. In some embodiments, the width D1 of the first end face may also be greater than the width D2 of the second sheath end 124, such as... Figure 8 , Figure 10As shown. When there is a gradient difference between the first sheath end 114 and the second sheath end 124, the sheath tube is easy to enter the gap between the first sheath end 114 and the second sheath end 124 when the sheath is pressed. The protrusion 200 provided at the first sheath end 114 and extending outward can reduce the risk of the sheath tube entering the gap between the first sheath end 114 and the second sheath end 124.

[0074] In this embodiment, see Figure 6 , Figure 8 The protrusion 200 also has a second end face 202, which is located on the side opposite to the first end face 201. The second end face 202 of the protrusion 200 is flush with the end face 1141 of the first sheath end. This structure of the protrusion 200 eliminates the gradient difference between the two sheath ends, such as... Figure 7 As shown, during insertion, the end face of the second insertion end 124 will not touch the end face of the sheath tube, thus effectively preventing the end face of the second insertion end 124 from contacting the end face of the sheath tube, reducing loading resistance, and at the same time, the second insertion end 124 will not damage the sheath tube. Of course, in other embodiments, the protrusion 200 can also extend towards the ventricular end to exceed the end face 1141 of the first insertion end, which can also solve the problem of the second insertion end 124 contacting the sheath tube 410 during insertion, and is not limited here.

[0075] Furthermore, in this embodiment, the first end face 201 of the protrusion 200 abuts against the end face 1241 of the second sheath end. Due to the abutting action of the protrusion 200, the sheath tube 410 will not enter the support interlayer from the second sheath end 124 when inserted into the sheath.

[0076] See also Figure 4 , Figure 6 , Figure 7 In this embodiment, the first end face 201 of the protrusion 200 matches the end face 1241 of the second insertion sheath. Matching means that the dimensions are identical and the two end faces form a concave-convex match. Therefore, when the first insertion sheath 114 and the second insertion sheath 124 abut against each other, each insertion sheath assembly 101 acts as a whole, reducing the risk of the sheath 410 entering the interstitial space and making the loading and release process of the valve prosthesis smoother.

[0077] In this embodiment, the protrusion 200 is integrally formed on the first sheath end 114, which has the advantages of simple, stable, and reliable molding process. Of course, in other alternative embodiments, the protrusion 200 can be formed separately and then fixed to the first sheath end 114; or, the protrusion 200 can also be movably connected to the first sheath end 114, such as by rotational connection. Alternatively, the protrusion 200 can also be designed as a removable structure, covering the free end of the sheath end assembly 101. In this case, the protrusion 200 should be made of a biodegradable material, such as polylactic acid.

[0078] In this embodiment, the protrusion 200 may also have certain functions, such as being used as a hanging ear or a fixing ear.

[0079] Example 2

[0080] This embodiment provides a valve stent, which is an improvement on embodiment 1, wherein the outer contour of the protrusion 200 is arc-shaped.

[0081] like Figure 9 As shown, since the first end face 201 of the protrusion 200 abuts against the end face 1241 of the second sheath end, the arc-shaped outer contour can reduce the friction between the sheath end face and the inner wall of the sheath, further reducing the loading resistance.

[0082] Example 3

[0083] This embodiment provides a valve stent, which is an improvement on embodiment 1 or embodiment 2, wherein the axial contact surfaces of the first insertion sheath end 114 and the second insertion sheath end 124 are configured to be concave-convex matching connections.

[0084] See Figure 10 The second sheath end 124 has multiple second protrusions protruding outward from its axial side, with a second recess formed between two adjacent second protrusions. Correspondingly, the first sheath end 114 has multiple first recesses formed on its axial side, with a first protrusion between two adjacent first recesses 116. After the inner support 110 and the outer support 120 are connected, the first protrusions are located in a corresponding second recess, and the second protrusions are located in a corresponding first recess, thus forming a concave-convex matching connection between the first sheath end 114 and the second sheath end 124. The protrusions and recesses are matched one-to-one. The number and position of the protrusions and recesses can be selected according to actual connection requirements and are not intended to limit the scope of protection of this invention; further details are omitted here.

[0085] The concave-convex matching connection between the first sheath end 114 and the second sheath end 124 enables each sheath end group 101 to complete the predetermined shape, which can replace connection methods such as welding and has the advantages of stable connection and easy implementation.

[0086] The above description discloses only preferred embodiments of the present invention. These preferred embodiments do not exhaustively describe all details, nor do they limit the invention to the specific implementations described. Clearly, many modifications and variations can be made based on the content of this specification. This specification selects and specifically describes these embodiments to better explain the principles and practical applications of the invention, thereby enabling those skilled in the art to make good use of the invention. The present invention is limited only by the claims and their full scope and equivalents.

Claims

1. A valve stent, characterized in that, The support assembly includes at least two supports, an inner support and an outer support, wherein the inner support and the outer support are nested, the inner support is sleeved inside, and the support assembly is configured to have at least one sheath end group. The sheath end assembly includes a first sheath end and a second sheath end. The first sheath end is located on the inner support layer, and the second sheath end is located on the outer support layer. The first sheath end and the second sheath end extend in the same direction, and the second sheath end is located outside the first sheath end. When the length of the first sheath end in at least one of the sheath end groups is greater than the length of the second sheath end, the sheath end group is provided with a protrusion to prevent the sheath end group from interfering with the loading of the valve prosthesis. The stent assembly includes a plurality of sheath end groups, each of which is located at the atrial end or the ventricular end; in each of the sheath end groups, when the length of the first sheath end is greater than the length of the second sheath end, each of the sheath end groups is provided with the protrusion. The protrusion is provided at the first sheath end, the protrusion has a first end face, the first end face is located on one side of the end face near the second sheath end, and the width of the first end face is not less than the width of the second sheath end; The axial contact surfaces of the first sheath end and the second sheath end are configured to be concave-convex matching; the first sheath end is a lug for connection with the conveying system.

2. The valve stent according to claim 1, characterized in that, The protrusion also has a second end face, which is located on the side opposite to the first end face and is flush with the end face of the first sheath end.

3. The valve stent according to claim 1, characterized in that, The first end face of the protrusion abuts against the end face of the second sheath end.

4. The valve stent according to claim 3, characterized in that, The shape of the first end face matches the shape of the end face of the second sheath end.

5. The valve stent according to any one of claims 1-4, characterized in that, The outer contour of the protrusion is arc-shaped.

6. The valve stent according to any one of claims 1-4, characterized in that, The protrusion is integrally formed at the first sheath end.

7. An artificial heart valve comprising a valve stent as described in any one of claims 1-6.

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