Artificial heart valve and its stent, as well as artificial heart valve replacement system

Abstract

The present invention discloses an artificial heart valve stent, an artificial heart valve, and an artificial heart valve replacement system. The artificial heart valve stent includes an inner stent and an outer stent connected to each other; the outer stent includes an outer main body section, and an outer skirt section extending from the outer main body section and located radially outside the outer main body section, and the outer skirt section is located between the inflow end and the outflow end of the outer main body section; the inner stent includes an inner main body section at least partially located within the outer main body section of the outer stent, and an inner skirt section protruding radially outside the inner main body section from the inflow end of the inner main body section; the inner skirt section protrudes radially outside the inflow end of the outer main body section, and the outer skirt section, the inner skirt section, and the section of the outer main body section located between the outer skirt section and the inner skirt section together form an accommodation space opening radially outward. The artificial heart valve stent can reduce damage to the annulus tissue.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to an artificial heart valve stent, an artificial heart valve having the artificial heart valve stent, and a replacement system for the artificial heart valve. Background Art

[0002] Heart valves play an important role as one-way "valves" in the blood circulation of the heart, preventing blood reflux. The mitral valve (which prevents blood from refluxing from the left ventricle (abbreviation: LV) to the left atrium (abbreviation: LA)) and the tricuspid valve (which prevents blood from refluxing from the right ventricle (abbreviation: RV) to the right atrium (abbreviation: RA)) are important heart valves, usually including an annulus, leaflets, chordae tendineae, and papillary muscles. The leaflets of a normal mitral or tricuspid valve can tightly close when the ventricle is in a systolic state, completely blocking blood from refluxing from the ventricle to the atrium, while the leaflets of a diseased mitral or tricuspid valve often cannot close tightly, resulting in mitral regurgitation (MR) or tricuspid regurgitation (TR).

[0003] To treat patients with heart valve diseases, especially those with severe heart valve diseases, in recent years, an artificial heart valve is often implanted into the native mitral or tricuspid valve in situ in the heart through a minimally invasive interventional surgery to replace the diseased native valve. An artificial heart valve usually includes a stent and artificial leaflets disposed within the stent, where the stent is used to be positioned at the native mitral or tricuspid valve in the heart, and the artificial leaflets are used as one-way "valves" to prevent blood reflux. There is an existing artificial heart valve that, when implanted into the native mitral or tricuspid valve in the heart, achieves the purpose of positioning the artificial heart valve by piercing barbs on its stent into the annulus.

[0004] However, this artificial heart valve that achieves positioning by piercing barbs into the annulus is bound to cause damage to the annulus, and this damage is dynamic and gradually intensifies with the beating of the heart. Summary of the Invention

[0005] An object of the present invention is to provide an artificial heart valve stent, an artificial heart valve having the artificial heart valve stent, and a replacement system for the artificial heart valve, which can reduce or at least reduce to a certain extent the damage to the annulus tissue.

[0006] To this end, on the one hand, the present invention provides an artificial heart valve stent, comprising an inner stent and an outer stent connected to each other; the outer stent includes an outer main body section, and an outer skirt section extending from the outer main body section and located radially outside the outer main body section, wherein the outer skirt section is located between the inflow end and the outflow end of the outer main body section; the inner stent includes an inner main body section at least partially located within the outer main body section of the outer stent, and an inner skirt section protruding radially outside the inner main body section from the inflow end of the inner main body section; wherein, the inner skirt section protrudes radially outside the inflow end of the outer main body section, and the outer skirt section, the inner skirt section, and the section of the outer main body section located between the outer skirt section and the inner skirt section together form an accommodation space opening radially outwards.

[0007] On the other hand, the present invention provides an artificial heart valve, comprising at least two artificial valve leaflets and the aforementioned artificial heart valve stent; the artificial valve leaflets are fixedly connected to the inner main body section in the inner main body section of the inner stent of the artificial heart valve stent; the edges of at least two artificial valve leaflets are butt-jointed with each other circumferentially; the artificial heart valve is used to replace the native mitral valve or the native tricuspid valve.

[0008] In yet another aspect, the present invention provides an artificial heart valve replacement system, comprising the aforementioned artificial heart valve and a delivery device for delivering the artificial heart valve. The artificial heart valve has a delivery state after radial compression and a natural state after radial expansion. The delivery device includes an outer sheath tube and an inner core disposed within the outer sheath tube. The inner core and the outer sheath tube can move relative to each other axially. The artificial heart valve is received in the gap between the distal portion of the inner core and the distal portion of the outer sheath tube after being radially compressed.

[0009] The artificial heart valve stent of the present invention forms an accommodation space opening radially outwards through the outer skirt section located radially outside the outer main body section, the inner skirt section protruding radially outside the inner main body section, and the section of the outer main body section located between the outer skirt section and the inner skirt section. When implanted in the heart, the annulus tissue can be received in this accommodation space. The section of the outer main body section located between the outer skirt section and the inner skirt section radially supports the annulus tissue. The outer skirt section is blocked by the annulus tissue to prevent the artificial heart valve stent from shifting towards the atrial side, and the inner skirt section is blocked by the annulus tissue to prevent the artificial heart valve stent from shifting towards the ventricular side, thereby positioning the artificial heart valve stent, and there is no need to use barbs to pierce the annulus to position the artificial heart valve stent as in the prior art. Therefore, the damage to the annulus tissue can be reduced to a certain extent at least. Description of the Drawings

[0010] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required for the description of the embodiments or the prior art. Obviously, the drawings in the following description are some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on these drawings.

[0011] Figure 1 Schematic three-dimensional structure diagram of the artificial heart valve according to Embodiment 1 of the present invention;

[0012] Figure 2 Is Figure 1 Front view of the shown artificial heart valve;

[0013] Figure 3 Is Figure 1 Exploded view of the shown artificial heart valve;

[0014] Figure 4a Is Figure 1 Schematic diagram of the shown artificial heart valve implanted into the human heart, where the artificial valve leaf and the flow-blocking membrane of the artificial heart valve are not shown;

[0015] Figure 4b Is Figure 4a Partial enlarged view of [];

[0016] Figure 4c Is Figure 4a Schematic diagram of the cooperation between the artificial heart valve and the valve annulus in [];

[0017] Figure 5 Is Figure 1 Front view of the artificial heart valve stent of the shown artificial heart valve, where the flow-blocking membrane is not shown;

[0018] Figure 6 Is Figure 5 Front view of the inner stent of the shown artificial heart valve stent;

[0019] Figure 7 Is Figure 5 Front view of the outer stent of the shown artificial heart valve stent;

[0020] Figure 8a Is Figure 7 Top view of the outer main body section of the shown outer stent;

[0021] Figure 8b Shows a similar Figure 8a Another variant of the shown outer main body section;

[0022] Figure 9a Is Figure 7 Front view of the limiting rod of the shown outer stent;

[0023] Figure 9b shows a similar Figure 9a another variant of the shown limit rod;

[0024] Figure 9c shows a similar Figure 9a yet another variant of the shown limit rod;

[0025] Figure 10a is Figure 7 a partial enlarged view of the shown outer bracket, which shows a support unit composed of two support rods;

[0026] Figure 10b shows a similar Figure 10a another variant of the support unit in ;

[0027] Figure 10c shows a similar Figure 10a yet another variant of the support unit in ;

[0028] Figure 10d shows a similar Figure 10a yet another variant of the support unit in ;

[0029] Figure 11a shows a similar Figure 10a another variant of the support unit in , where the support unit is generally rod-shaped;

[0030] Figure 11b shows a similar Figure 11a another variant of the support unit in ;

[0031] Figure 11c shows a similar Figure 11a yet another variant of the support unit in ;

[0032] Figure 11d shows a similar Figure 11a yet another variant of the support unit in ;

[0033] Figure 12 is the front view of the outer bracket of the artificial heart valve according to the second embodiment of the present invention;

[0034] Figure 13a is Figure 12 a partial enlarged view of ;

[0035] Figure 13b shows a similar Figure 13a another variant of the imaging mechanism in ;

[0036] Figure 13c shows a similar Figure 13a yet another variant of the imaging mechanism in ;

[0037] Figure 14aFront view of the outer stent of the artificial heart valve according to Embodiment 3 of the present invention;

[0038] Figure 14b Shows a similar Figure 14a Another variant of the outer stent shown;

[0039] Figure 15 Front view of the outer stent of the artificial heart valve according to Embodiment 4 of the present invention;

[0040] Figure 16 Is Figure 15 Exploded view of the outer stent shown;

[0041] Figure 17 Front view of the artificial heart valve according to Embodiment 5 of the present invention;

[0042] Figure 18 Is Figure 17 Exploded view of the artificial heart valve shown;

[0043] Figure 19 Is Figure 17 Schematic diagram of the cooperation between the artificial heart valve shown and the valve annulus;

[0044] Figure 20 Front view of the artificial heart valve stent of the artificial heart valve according to Embodiment 6 of the present invention, where the flow blocking membrane is not shown;

[0045] Figure 21 Is Figure 20 Front view of the outer stent of the artificial heart valve stent shown;

[0046] Figure 22 Is Figure 20 Schematic diagram of the cooperation between the artificial heart valve stent shown and the valve annulus;

[0047] Figure 23 Front view of the artificial heart valve stent of the artificial heart valve according to Embodiment 7 of the present invention, where the flow blocking membrane is not shown;

[0048] Figure 24 Is Figure 23 Front view of the outer stent of the artificial heart valve stent shown;

[0049] Figure 25 Is Figure 23 Schematic diagram of the cooperation between the artificial heart valve stent shown and the valve annulus;

[0050] Figure 26 Schematic diagram of an artificial heart valve replacement system according to an embodiment of the present invention. Detailed implementation manners

[0051] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. Apparently, the described embodiments are some, but not all, of the embodiments of the present invention. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention. In addition, as long as there is no contradiction or conflict among the following-described embodiments, they can be combined with each other, and the same or similar concepts or processes may not be repeated in some embodiments.

[0052] First, it should be noted that according to the blood flow direction during ventricular diastole, the "inflow end" and "outflow end" of the artificial heart valve stent and its components, as well as the artificial heart valve and its components, are defined. The "inflow end" refers to the end close to the blood inflow side or the atrial side; the "outflow end" refers to the end close to the blood outflow side or the ventricular side.

[0053] "Axial direction" refers to the direction parallel to the line connecting the centers of the outflow end and the inflow end. "Radial direction" refers to the direction perpendicular to or substantially perpendicular to the axial direction. "Circumferential direction" refers to the direction surrounding the axial direction. "Central axis" refers to the center line connecting the outflow end and the inflow end. "Above", "upper layer", "top", or similar terms refer to the orientation close to the inflow end. "Below", "lower layer", "bottom", or similar terms refer to the orientation close to the outflow end. "Radial outer side" is the side along the radial direction away from the central axis. "Radial inner side" is the side along the radial direction close to the central axis.

[0054] "Inner" / "outer" is a set of relative concepts, referring to that a feature or the whole part of the component where the feature is located is at least partially located on the radial inner side / radial outer side of another feature or the whole part of the component where the other feature is located.

[0055] "Initial end" refers to the connection end of a feature for connecting with its adjacent feature. "Terminal end" refers to the end of a feature opposite to its initial end, and in some cases, it is also the "free end".

[0056] "Proximal end" refers to the end of a device or component close to the operator. "Distal end" refers to the end of a device or component far from the operator.

[0057] It should be noted that the above terms indicating orientation or positional relationship are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or component referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as a limitation to the present invention.

[0058] Reference Figures 1 to 3, the artificial heart valve 100 according to the first embodiment of the present invention includes an artificial heart valve stent 10 and at least two artificial valve leaflets 20 disposed within the artificial heart valve stent 10. The artificial heart valve stent 10 includes an inner stent 30 and an outer stent 40 connected to each other. Preferably, the inner stent 30 is coaxially disposed within the outer stent 40. In other words, the central axis of the inner stent 30 described herein coincides with the central axis of the outer stent 40, and both are represented by L herein.

[0059] It should be noted that the artificial heart valve stent 10 of the present invention has a delivery state after radial compression and a natural state after radial expansion. In the delivery state, the artificial heart valve stent 10 is radially compressed by an external force so that it can be compressed and loaded into a sheath tube with a smaller radial dimension, and thus is delivered to the heart through a delivery device. In the natural state, the artificial heart valve stent 10 is not affected by an external force and radially expands naturally. Unless otherwise specified hereinafter, the structural features described are those of the artificial heart valve stent 10 in the natural state.

[0060] The outer stent 40 includes an outer main body section 41 and an outer skirt section 42 extending from the outer main body section 41 and located radially outside the outer main body section 41, wherein the outer skirt section 42 is located between the inflow end 410 and the outflow end 411 of the outer main body section 41.

[0061] The inner stent 30 includes an inner main body section 31 at least partially located within the outer stent 40 and an inner skirt section 32 protruding radially outside the inner main body section 31 from the inflow end 310 of the inner main body section 31, and the inner skirt section 32 also protrudes radially outside the inflow end 410 of the outer main body section 41, so that the inner skirt section 32, the outer skirt section 42, and the section of the outer main body section 41 located between the outer skirt section 42 and the inner skirt section 32 together form an accommodation space 50 opening radially outward.

[0062] It should be noted that, as described above, "inner" / "outer" are a set of relative concepts, which means that a feature or the whole part of the component where the feature is located is at least partially located radially inside / outside another feature or the whole part of the component where the other feature is located. Therefore, the aforementioned inner skirt section 32 does not mean being located radially inside the outer skirt section 42, but the whole inner stent 30 where the inner skirt section 32 is located is at least partially located radially inside the whole outer stent 40 where the outer skirt section 42 is located.

[0063] In this embodiment, the at least two artificial valve leaflets 20 are disposed within the inner body section 31 and fixedly connected to the inner body section 31 (e.g., by suture), and the edges of the at least two artificial valve leaflets 20 are butt-jointed with each other in the circumferential direction. The material of the artificial valve leaflets 20 is preferably biological tissue materials such as bovine pericardium and porcine pericardium, or polymer materials such as ultra-high molecular weight polyethylene can also be selected.

[0064] Reference Figures 4a to 4c , the artificial heart valve 100 is implanted into the native valve to be replaced in the heart, for example, at the mitral valve MV located between the left atrium LA and the left ventricle LV, and the corresponding valve annulus MVA is received in the accommodation space 50 of the artificial heart valve stent 10, thereby positioning the artificial heart valve 100. When the left ventricle LV is in a compressed state, the at least two artificial valve leaflets 20 are tightly closed to prevent blood from flowing back from the left ventricle LV to the left atrium LA; when the left ventricle LV is in a dilated state, the at least two artificial valve leaflets 20 open to allow blood to flow from the left atrium LA into the left ventricle LV.

[0065] It is not difficult to find that the artificial heart valve 100 in this embodiment uses the accommodation space 50 of its stent 10 to receive the valve annulus MVA. The section of the outer body section 41 of the artificial heart valve stent 10 located between the outer skirt section 42 and the inner skirt section 32 radially supports the valve annulus MVA. The outer skirt section 42 is blocked by the valve annulus MVA to prevent the artificial heart valve stent 10 from shifting toward the atrial side, and the inner skirt section 32 is blocked by the valve annulus MVA to prevent the artificial heart valve stent 10 from shifting toward the ventricular side, thereby realizing the positioning of the artificial heart valve 100, without the need to use barbs to pierce the valve annulus MVA to position the artificial heart valve stent as in the prior art, so the damage to the valve annulus MVA can be reduced.

[0066] It can be understood that the artificial heart valve 100 can be implanted into the heart by minimally invasive interventional surgery. For example, the radially compressed artificial heart valve 100 can be received by a delivery device (to be described in detail below), and then through the apex, through the atrium or through the femoral vein - superior vena cava - right atrium - interatrial septum - left atrium route, the artificial heart valve 100 is delivered to the vicinity of the mitral valve and released to replace the diseased native valve.

[0067] Alternatively, the artificial heart valve 100 can also be directly implanted into the heart by other means such as surgical operation to replace the diseased native valve.

[0068] It can also be understood that, as Figures 4a to 4c shown, the use of the artificial heart valve 100 to replace the diseased native mitral valve is only shown as an example. In other embodiments, the artificial heart valve 100 can also be used to replace other appropriate native valves, such as the tricuspid valve.

[0069] refer to Figure 3 , Figure 5 and Figure 6 In this embodiment, the inner main body section 31 of the inner bracket 30 is roughly in the shape of a hollow cylinder with two ends open. Preferably, the outer diameter of the inner main body section 31 ranges from 25 mm to 30 mm. Also preferably, the inner main body section 31 is covered with a flow-blocking film 311. The material of the flow-blocking film 311 is preferably PET, PTFE, etc.

[0070] In this embodiment, the inner main body section 31 includes an inner mesh structure 33 formed by a plurality of support rods 312 interlaced and connected. The inner mesh structure 33 is composed of multiple layers of inner annular units 330 (e.g. Figure 6 The two layers of inner annular units 330A, 330B shown are arranged axially, and each layer of inner annular units 330 is composed of a plurality of cells 331 arranged circumferentially, wherein each cell 331 is surrounded by a plurality of struts 312 and has an opening 332. Preferably, each layer of inner annular units 330 is composed of a plurality of rhombus cells 331 arranged circumferentially, wherein a plurality of struts 312 of the upper layer inner annular unit 330A close to the inflow end 310 of the inner main body section 31 form a plurality of circumferentially alternately distributed crests 314A and troughs 314B, and a plurality of struts 312 of the lower layer inner annular unit 330B close to the outflow end 313 of the inner main body section 31 form a plurality of circumferentially alternately distributed crests 315A and troughs 315B.

[0071] In this embodiment, the inner main body section 31 further includes an inner connection structure 35 provided at the outflow end of the inner mesh structure 33, for connecting the outer bracket 40 (the corresponding connection structure of the outer bracket 40 will be described below). In this embodiment, the inner connection structure 35 includes a plurality of inner connection units 350 arranged at intervals along the circumferential direction. Each trough 315B of the outflow end of the inner mesh structure 33 is connected to an inner connection unit 350. In this embodiment, each inner connection unit 350 is roughly rod-shaped, extending axially downward from a corresponding trough 315B of the outflow end of the inner mesh structure 33, and expanding at its end to form an inner connection hole 351 that penetrates itself radially.

[0072] In this embodiment, the inner skirt section 32 of the inner stent 30 is roughly trumpet-shaped. The inner skirt section 32 is covered with a flow-blocking membrane 320 to seal on the atrial side to prevent paravalvular leakage. The material of the flow-blocking membrane 320 is preferably PET, PTFE, etc. Preferably, the inner skirt section 32 extends outward from the inflow end 310 of the inner main body section 31 away from the central axis L of the inner stent 30 and also extends axially toward the inflow end 310 away from the inner main body section 31.Figure 6 It can be observed that the inner skirt section 32 generally extends obliquely upward and outward.

[0073] Preferably, the range of the angle A1 between the initial end 321 of the inner skirt section 32 (i.e., the end close to the inner main body section 31, which is also the connection end) or the tangent of the initial end 321 of the inner skirt section 32 and the central axis L of the inner stent 30 is 45° to 90°, which can enable the inner skirt section 32 to better adapt to the structure of the valve annulus MVA and reduce the possibility of paravalvular leakage. Preferably, the inclination angle A2 of the end 322 of the inner skirt section 32 (i.e., the end far from the inner main body section 31, which is also the free end) relative to the central axis L of the inner stent 30 is smaller than the inclination angle A1 of the initial end 321 of the inner skirt section 32 relative to the central axis L of the inner stent 30, which can enable the inner skirt section 32 to better fit with the valve annulus MVA, further improve the positioning stability of the artificial heart valve stent 10 and reduce the possibility of paravalvular leakage.

[0074] Preferably, the range of the diameter D1 of the end 322 of the inner skirt section 32 is 40 mm to 70 mm, which is about 10 mm larger than the inner diameter of the conventional native valve annulus MVA, and can effectively prevent the artificial heart valve 100 from shifting toward the ventricular side and reduce the possibility of paravalvular leakage.

[0075] Optionally, the inner skirt section 32 of the inner stent 30 includes a plurality of inner skirt units 323 distributed circumferentially. Each inner skirt unit 323 includes two struts 324. The initial ends 321 of the two struts 324 are directly or indirectly connected to a corresponding peak portion 314A at the inflow end of the inner mesh structure 33 respectively, and the ends 322 of the two struts 324 are connected. The range of the angle A3 between the two struts 324 of each inner skirt unit 323 is preferably 30° to 150°. Preferably, the two struts 324 of each inner skirt unit 323 are directly or indirectly connected to two adjacent peak portions 314A at the inflow end of the inner mesh structure 33. More preferably, the two adjacent struts 324 of two adjacent inner skirt units 323 of the inner skirt section 32 intersect, that is, they correspond to the same peak portion 314A at the inflow end of the inner mesh structure 33. The range of the angle A4 between the two adjacent struts 324 of two adjacent inner skirt units 323 is preferably 30° to 150°. It can be seen that the peak portions 314A at the inflow end of the inner mesh structure 33 are all directly or indirectly connected to a corresponding strut 324 of the inner skirt section 32. It can be understood that in other embodiments, the inner skirt section 32 can also adopt other structures as long as it can be supported on the atrial side of the valve annulus MVA.

[0076] Preferably, the inner stent 30 further includes a connecting section 36 for connecting the inner skirt section 32 and the inner main body section 31. The connecting section 36 is preferably covered with a flow blocking film 360. The material of the flow blocking film 360 is preferably PET, PTFE, etc. In this embodiment, the connecting section 36 includes a plurality of connecting rods 361 spaced circumferentially. One end of the connecting rod 361 is connected to the intersection of two adjacent inner skirt units 323 of the inner skirt section 32, and the other end is connected to a corresponding peak portion 314A at the inflow end of the inner mesh structure 33 of the inner main body section 31. Preferably, the connecting rod 361 is curved and transitions from a corresponding peak portion 314A at the inflow end of the inner mesh structure 33 to the intersection of the corresponding two adjacent inner skirt units 323 to prevent the connecting rod 361 from breaking.

[0077] Optionally, the inner skirt section 32, the inner main body section 31, and the connecting section 36 can be separately formed and then connected to the inner skirt section 32 and the inner main body section 31 through the connecting section 36 (such as by crimping, riveting, welding, or sewing).

[0078] Preferably, the inner skirt section 32, the inner main body section 31, and the connecting section 36 are integrally formed. In other words, the inner stent 30 is preferably a single piece.

[0079] Optionally, the inner stent 30 or each part of the inner stent 30 is formed into the required shape by laser cutting a shape memory function tube such as a nitinol tube and undergoing heat setting treatment. Alternatively, the inner stent 30 or each part of the inner stent 30 can also be formed into the required shape by braiding shape memory function wires such as nitinol alloy wires and undergoing heat setting treatment.

[0080] Reference Figure 3 、 Figure 5 and Figure 7In this embodiment, the inflow end 410 of the outer main body section 41 of the outer stent 40 is freely suspended, and a radial gap 60 is formed between a section of the outer main body section 41 located between the outer skirt section 42 and the inner skirt section 32 (the section supports the valve ring tissue in the radial direction and can be called a supporting section) and the inner main body section 31. The radial distance L1 of the radial gap 60 is preferably in the range of 1 mm to 18 mm, more preferably 5 mm to 18 mm. The design of the radial gap 60 allows the support section on the outer support 40 to be radially spaced from the inner main body section 31 of the inner support 30. When the outer support 40 of the artificial heart valve 100 that has been implanted in the heart is deformed inwardly due to the radial squeezing of the valve ring MVA, the radial gap 60 provides sufficient deformation space for the support section on the outer support 20. Therefore, the radial squeezing and deformation of the outer support 40 due to the valve ring will not affect the inner skirt section 32 of the inner support 30, thereby avoiding the inner skirt section 32 from being affected by the deformation of the outer support 40 and causing a gap with the atrial side of the valve ring. At the same time, the inner skirt section 32 is also covered with a flow-blocking membrane 320, which can effectively isolate the atrium and ventricle, ensure the sealing of the atrial side, and reduce the risk of paravalvular leakage.

[0081] In this embodiment, the outer body section 41 of the outer bracket 40 includes an outer mesh structure 44 formed by a plurality of cross-connected support rods 412. The outer mesh structure 44 includes a bottom section 45 extending outward away from the central axis L of the outer bracket 40 and also extending toward the inner skirt section 32, and a top section 46 extending from the inflow end of the bottom section 45 further toward the inner skirt section 32.

[0082] In this embodiment, the bottom section 45 is generally funnel-shaped, and gradually converges toward the central axis L of the outer bracket 40 from its inflow end 450 toward its outflow end 451. The greater the convergence angle, that is, the greater the degree of inclination toward the central axis L of the outer bracket 40, the shorter the axial length of the bottom section 45; conversely, the smaller the convergence angle, that is, the smaller the degree of inclination toward the central axis L of the outer bracket 40, the longer the axial length of the bottom section 45. In order to reduce the overall height of the outer bracket 40, preferably, the angle A5 formed by two radially opposite tangents of the outflow end 451 of the bottom section 45 is in the range of 90° to 150°.

[0083] refer to Figure 3 , Figure 5 , Figure 7 as well as Figure 8a, in this embodiment, the top section 46 is generally in the shape of a hollow cylinder with openings at both ends, and the shape of its circumferential outer contour is "O", which helps to simplify the manufacturing process of the outer stent 40. In other words, the diameters of various parts of the top section 46 in this embodiment are generally the same. Preferably, the range of the diameter D2 of the top section 46 is 30 mm to 60 mm, which is equivalent to the inner diameter of the native annulus MVA, and helps the annulus MVA to stably radially compress the top section 46.

[0084] Reference Figure 8b , in other embodiments, the circumferential outer contour of the top section 146 can also adopt other shapes, such as "D", which helps the top section 146 to better adapt to the structure of the native annulus MVA and avoid compressing the ventricular outflow tract.

[0085] Refer again to Figure 3 、 Figure 5 and Figure 7 , in this embodiment, the outer mesh structure 44 of the outer main body section 41 is formed by arranging multiple layers of outer annular units 440 along the axial direction, and each layer of outer annular unit 440 is formed by arranging multiple cells 441 along the circumferential direction, where each cell 441 is enclosed by multiple struts 412 and has an opening 442.

[0086] Preferably, the anti-deformation ability of the outer mesh structure 44 of the outer main body section 41 is lower than that of the inner mesh structure 33 of the inner main body section 31, so that the outer stent 40 can better adapt to the native annulus MVA, and at the same time, the inner stent 30 is sufficient to withstand the pulling force of the artificial leaflet 20 and is not easily deformed. The so-called anti-deformation ability refers to the ability to resist deformation under external stress. Under the same stress, the higher the anti-deformation ability, the smaller the deformation amplitude, and vice versa. This can be achieved, for example, by making the area of the opening 442 of the cell 441 of the outer mesh structure 44 larger than the area of the opening 332 of the cell 331 of the inner mesh structure 33. It can be understood that in other embodiments, other methods can also be used, such as by selecting materials with different hardnesses, different strut sizes, etc., to make the anti-deformation ability of the inner main body section 31 higher than that of the outer main body section 41. It can be understood that the greater the hardness of the material, the higher the anti-deformation ability, and the larger the size of the strut, the higher the anti-deformation ability.

[0087] In this embodiment, the outer mesh structure 44 is formed by two layers of outer ring units 440 arranged in an interleaved manner, such that each cell 441 of one outer ring unit 440 is adjacent to two adjacent cells 441 of another adjacent outer ring unit 440. Preferably, the area of the opening 442A of the cell 441A of the upper outer ring unit 440A mainly used to form the top section 46 is larger than the area of the opening 442B of the cell 441B of the lower outer ring unit 440B mainly used to form the bottom section 45, so that the anti-deformation ability of the top section 46 is lower than that of the bottom section 45. This can not only improve the flexibility of the top section 46, thereby enhancing the adaptability of the top section 46 to the mitral valve annulus MVA, but also make the bottom section 45 not easily deformed and maintain its shape. It can be understood that in other embodiments, other methods can also be adopted, such as by selecting materials with different hardnesses, different strut sizes, etc., to make the anti-deformation ability of the top section 46 lower than that of the bottom section 45. It can be understood that the greater the hardness of the material, the higher the anti-deformation ability, and the larger the size of the strut, the higher the anti-deformation ability.

[0088] In this embodiment, each of the outer ring units 440 is formed by a plurality of diamond-shaped cells 441 arranged circumferentially, that is, each outer ring unit 440 is formed by two layers of corrugated rods 443 connected axially. Each layer of corrugated rods 443 is formed by a plurality of struts 412 connected end to end circumferentially and has a plurality of wave crest portions 444A and wave trough portions 444B alternately distributed circumferentially. The two outer ring units 440A and 440B share the middle layer corrugated rod 443B.

[0089] Preferably, the width of the struts 412 of the three layers of corrugated rods 443 of the outer mesh structure 44 (that is, the distance between the two long sides of the radially inner side or the radially outer side of the strut 412) gradually increases from the inlet end to the outlet end of the outer mesh structure 44, which helps to further improve the compliance of the top section 46, thereby further enhancing the adaptability of the top section 46 to the mitral valve annulus MVA. More preferably, the width of all the struts 412 of the outer mesh structure 44 is not greater than 0.5 mm. Most preferably, the widths of the struts 412 of the upper layer corrugated rod 443A, the middle layer corrugated rod 443B, and the lower layer corrugated rod 443C of the outer mesh structure 44 are 0.3 mm, 0.4 mm, and 0.5 mm respectively.

[0090] In this embodiment, the outer main body section 41 of the outer stent 40 further includes an outer connection structure 47 provided at the outflow end of the outer mesh structure 44 for connecting to the inner connection structure 35 of the inner stent 30. The outer connection structure 47 includes a plurality of outer connection units 470 arranged at intervals in the circumferential direction. Preferably, each trough portion 444B at the outflow end of the outer mesh structure 44 is correspondingly connected to an outer connection unit 470. In this embodiment, each outer connection unit 470 is generally rod-shaped, extends axially downward from a corresponding trough portion 444B at the outflow end of the outer mesh structure 44, and expands at its end to form an outer connection hole 471 that penetrates itself in the radial direction.

[0091] When connecting the outer stent 40 and the inner stent 30, the inner stent 30 can be placed inside the outer stent 40, such that the outer connection hole 471 is aligned with the corresponding inner connection hole 351, and then a connecting member such as a connecting pin is inserted into the outer connection hole 471 and the inner connection hole 351, thereby connecting the outer stent 40 and the inner stent 30. It can be understood that in other embodiments, other methods, such as suturing, can also be used to connect the outer stent 40 and the inner stent 30.

[0092] In this embodiment, the outer stent 40 further includes a limiting structure 43 provided at the end of the outer connection structure 47 for connecting to a delivery device (to be described in detail below). Optionally, the limiting structure 43 includes at least one limiting rod 430 provided at the end of the outer connection unit 470. Refer to Figure 9a , in this embodiment, the limiting rod 430 is generally T-shaped, and includes a rod portion 431 for connecting to the outer connection unit 470 and a engaging portion 432 formed by expanding from the end of the rod portion 431. In this embodiment, the axial cross-section of the engaging portion 432 of the limiting rod 430 is generally circular. It can be understood that in other embodiments, the engaging portion can also have other shapes. For example, as Figure 9b shown, in some embodiments, the axial cross-section of the engaging portion 432B can be rectangular. In some embodiments, as Figure 9c shown, the axial cross-section of the engaging portion 432C can be semi-circular.

[0093] Referring again to Figure 3 、 Figure 5 and Figure 7 , in this embodiment, the outer skirt section 42 of the outer stent 40 extends outward from a position approximately in the middle of the outer main body section 41 of the outer stent 40 away from the central axis L of the outer stent 40 and also extends towards the inner skirt section 32. From Figure 7It is observed that the outer skirt section 42 generally extends obliquely upward and outward. Preferably, the outer skirt section 42 extends outward from the intersection of the top section 46 and the bottom section 45. In other words, the outer skirt section 42 extends outward from the part of the outer main body section 41 with the largest diameter, and the support section of the outer main body section 41 located between the outer skirt section 42 and the inner skirt section 32 for forming the accommodation space 50 is the top section 46.

[0094] It can be understood that in other embodiments, the outer skirt section 42 may also extend outward from other parts of the outer main body section 41. For example, it may extend outward from a part of the top section 46 adjacent to its outflow end. In this case, a partial section of the top section 46 is configured as the support section for forming the accommodation space.

[0095] Preferably, the minimum axial distance H between the inner skirt section 32 and the outer skirt section 42 ranges from 5 mm to 15 mm, which is approximately equivalent to the thickness of the native annulus MVA. This can stably clamp the annulus MVA after it is received in the accommodation space 50 without a large gap that would cause the artificial heart valve stent 10 to shake, resulting in a better positioning effect.

[0096] Preferably, the angle A6 between the initial end 421 of the outer skirt section 42 (i.e., the end close to the outer main body section 41, also the connecting end) or the tangent of the initial end 421 of the outer skirt section 42 and the central axis L of the outer stent 40 ranges from 60° to 120°. The angle A7 between the terminal end 422 of the outer skirt section 42 (i.e., the end far from the outer main body section 41, also the free end) or the tangent of the terminal end 422 of the outer skirt section 42 and the central axis L of the outer stent 40 ranges from 60° to 120°.

[0097] More preferably, the outer skirt section 42 extends outward in an arc relative to the outer main body section 41 as a whole, and the angle A8 between the tangent at its approximate middle part and the central axis L of the outer stent 40 ranges from 30° to 90°. This helps the outer skirt section 42 to expand radially outward, and there is space for an arc transition between the initial end 421 and the terminal end 422.

[0098] Also preferably, the maximum outer diameter of the outer skirt section 42, which is the diameter D3 of the terminal end 422 of the outer skirt section 42 in this embodiment, ranges from 40 mm to 70 mm. This is approximately 10 mm larger than the inner diameter of the conventional native annulus MVA, which can effectively prevent the artificial heart valve 100 from shifting toward the atrial side.

[0099] Reference Figure 7 and Figure 10a, in this embodiment, the outer skirt section 42 includes a plurality of support units 423 that are evenly and spaced circumferentially. Each support unit 423 includes two support rods 424. Each support rod 424 includes a first end 425 that is away from the outer main body section 41 and connected to the other support rod 424, and a second end 426 that is connected to the outer main body section 41. In this embodiment, the second end 426 of each support rod 424 is connected to approximately the middle part of a corresponding strut 412 of the middle wave-shaped rod 443B. The first ends 425 of the two support rods 424 of each support unit 423 are connected to form, preferably, a blunt end such as an arc shape to reduce the irritation and damage to the native annulus MVA. The second ends 426 of the adjacent two support rods 424 of adjacent two support units 423 are arranged at intervals. Preferably, there is a cell 441 between the adjacent two support rods 424 of adjacent two support units 423. It can be understood that, in other embodiments, the outer skirt section 42 can also adopt other structures as long as it can support the ventricular side of the annulus MVA.

[0100] For example, as Figure 10b shown, in other embodiments, the two support rods 424B of the support unit 423B can extend in an arc shape from their first ends 425B in a direction away from the axis of symmetry of the support unit 423B (i.e., the axis between the two support rods 424B), which can increase the relative support area for the native annulus MVA. As Figure 10c shown, in other embodiments, each support rod 424C of the support unit 423C can extend from its first end 425C in a bent manner in a direction away from the axis of symmetry of the support unit 423C. As Figure 10d shown, in other embodiments, each support rod 424D of the support unit 423D can extend linearly from its first end 425D in a direction away from the axis of symmetry of the support unit 423D.

[0101] Again, for example, as Figure 11a shown, in other embodiments, each support unit 423E of the outer skirt section may no longer include two support rods 424. Instead, each support unit 423E can be generally rod-shaped. Preferably, the end of each rod-shaped support unit 423E is formed as a blunt end that extends outward in an arc shape relative to the outer main body section 41. Preferably, each support unit 423 extends outward from a corresponding trough portion 444B of the middle wave-shaped rod 443B or a corresponding peak portion 444A of the lower wave-shaped rod 443C.

[0102] Still again, for example, as Figure 11b shown, in other embodiments, the end of each rod-shaped support unit 423F can be formed as a round blunt end. As Figure 11cAs shown, in other embodiments, the end of each rod-shaped supporting unit 423G can be formed into a blunt end with a substantially "C" shape. As Figure 11d shown, in other embodiments, the end of each rod-shaped supporting unit 423H can be formed into a rectangular blunt end.

[0103] Optionally, the outer skirt section 42 and the outer main body section 41 are separately formed, and then the outer skirt section 42 is connected to the outer main body section 41 (such as by crimping, riveting, welding or sewing, etc.).

[0104] Preferably, the outer skirt section 42 and the outer main body section 41 are integrally formed. In other words, the outer stent 40 is preferably a single-piece.

[0105] Optionally, the outer stent 40 or each part of the outer stent 40 is formed into the required shape by laser cutting a shape memory function pipe such as a nitinol tube and undergoing heat setting treatment. Or, the outer stent 40 or each part of the outer stent 40 can also be formed into the required shape by braiding a shape memory function wire such as a nitinol wire and undergoing heat setting treatment.

[0106] Referring to Figure 12 , the artificial heart valve of the second embodiment of the present invention is similar to the artificial heart valve 100 of the first embodiment, and the same parts will not be described in detail here. The main difference between the artificial heart valve of the second embodiment of the present invention and the artificial heart valve 100 of the first embodiment is that: a developing mechanism 48 is further provided on the outer stent 140 of the artificial heart valve of the second embodiment of the present invention, so as to determine the actual position of the artificial heart valve when implanted in the body, especially when the artificial heart valve is implanted by minimally invasive interventional surgery. The material of the developing mechanism 48 can be a developing material visible under X-ray, such as tungsten, gold, platinum, tantalum, etc.

[0107] At the same time, referring to Figure 12 and Figure 13a shown, the developing mechanism 48 of the artificial heart valve of this embodiment includes a plurality of developing points 480. The developing points 480 can be fixed to the inflow end of the outer stent 140 by, for example, crimping. Preferably, the plurality of developing points 480 are evenly and spacedly distributed on a plurality of peak portions 444A at the inflow end of the top section 46 of the outer stent 140. It can be understood that in other embodiments, a plurality of developing points can also be provided at other parts of the artificial heart valve stent. For example, a plurality of developing points 480 can also be provided on the inner skirt section 32 of the inner stent 30. Or, only one developing point 480 can also be provided.

[0108] In other embodiments, the developing mechanism can also adopt other structures. For example, as Figure 13bAs shown, in other embodiments, the developing mechanism may include a plurality of developing segments 480B. Each developing segment 480B may be formed by fixing a section of developing wire / thread to a corresponding peak portion 444A at the inflow end of the top segment 46 by means such as winding. For another example, as Figure 13c shown, in other embodiments, the developing mechanism may be configured as a continuous and complete developing ring 480C. The developing ring 480C may be formed by threading a section of developing wire / thread through a plurality of peak portions 444A at the inflow end of the top segment 46 and fixing it to the inflow end of the top segment 46 by means such as stitching. It can be understood that, in other embodiments, the developing mechanism may also be formed into a continuous but incomplete structure, such as an arc or a semi-circle.

[0109] Refer to Figure 14a , the artificial heart valve in Embodiment 3 of the present invention is similar to the artificial heart valve 100 in Embodiment 1, and the same parts will not be described in detail here. The main difference between the artificial heart valve in Embodiment 3 of the present invention and the artificial heart valve 100 in Embodiment 1 is that: a protective film 427 is covered on the outer skirt section 42 of the artificial heart valve in Embodiment 3 of the present invention to further reduce the stimulation of the outer skirt section 42 to the valve annulus MVA and prevent the outer skirt section 42 from damaging the valve annulus MVA. The material of the protective film 427 is preferably PET, PTFE, etc. As can be seen from the figure, the protective film 427 in this embodiment is formed as a continuous ring. That is, the protective film 427 in this embodiment not only covers all the supporting units 423, but also covers the gaps between adjacent supporting units 423.

[0110] It can be understood that, in other embodiments, the protective film may also adopt other structures. For example, as Figure 14b shown, in other embodiments, the protective film 427B may include a plurality of circumferentially spaced segments, and each segment covers a corresponding supporting unit 423, which can also prevent the outer skirt section 42 from damaging the valve annulus MVA.

[0111] Refer to Figure 15 and Figure 16, the artificial heart valve of the fourth embodiment of the present invention is similar to the artificial heart valve 100 of the first embodiment, and the same parts will not be described herein again. The main difference between the artificial heart valve of the fourth embodiment of the present invention and the artificial heart valve 100 of the first embodiment is that: the outer skirt section 342 of the artificial heart valve of the fourth embodiment of the present invention is configured as a continuous ring. In other words, in this embodiment, the first ends 3425 of the two support rods 3424 of each support unit 3423 are connected, and the second ends 3426 of the adjacent two support rods 3424 of adjacent support units 3423 are also connected. Specifically, the first ends 3425 of the two support rods 3424 of each support unit 3423 extend outward to the radially outer side of the outer main body section 41 and are connected, preferably forming a blunt end such as an arc shape to reduce the stimulation to the native valve annulus MVA. The second ends 3426 of the two support rods 3424 of each support unit 3423 extend inward to the radially inner side of the outer main body section 41 and are connected to the second end 3426 of an adjacent support rod 3424 of an adjacent support unit 3423, and also preferably form a blunt end such as an arc shape.

[0112] Preferably, the outer skirt section 342 and the outer main body section 41 in this embodiment are separately formed, and then the outer skirt section 342 is connected to the outer main body section 41 by means such as suturing. More preferably, the outer skirt section 342 is formed into the required shape by braiding nickel-titanium alloy wires and undergoing heat setting treatment. The outer main body section 41 is formed into the required shape by laser cutting a nickel-titanium tube and undergoing heat setting treatment.

[0113] Reference Figures 17 to 19 , the artificial heart valve 500 of the fifth embodiment of the present invention is similar to the artificial heart valve 100 of the first embodiment, and the same parts will not be described herein again. The main difference between the artificial heart valve 500 of the fifth embodiment of the present invention and the artificial heart valve 100 of the first embodiment is that: a flow-blocking membrane 413 is also covered on the outer main body section 41 of the outer stent of the artificial heart valve 500 of the fifth embodiment of the present invention. The material of the flow-blocking membrane 413 is preferably PET, PTFE, etc. The atrial side of the valve annulus MVA is sealed by the flow-blocking membrane 320 of the inner skirt section 32, and the ventricular side of the valve annulus MVA is sealed by the flow-blocking membrane 413 of the outer main body section 41 to achieve double-layer sealing, thereby further enhancing the sealing effect of the artificial heart valve 500 and reducing the possibility of paravalvular leakage.

[0114] Reference Figures 20 to 22, the artificial heart valve of Embodiment VI of the present invention is similar to the artificial heart valve 100 of Embodiment I, and the same parts will not be described herein again. The main difference between the artificial heart valve of Embodiment VI of the present invention and the artificial heart valve 100 of Embodiment I is that: the diameters of the various parts of the top section 546 of the outer stent 540 of the artificial heart valve of Embodiment VI of the present invention are no longer the same. Instead, in this embodiment, the top section 546 of the outer stent 540 extends inward toward the central axis L of the outer stent 540 while extending axially toward the inner skirt section 32. In other words, the diameter of the top section 546 of the outer stent 540 in this embodiment gradually decreases from its outflow end to its inflow end, thus forming a structure that gradually inclines and converges toward the central axis L of the outer stent 540. This helps to further improve the adaptability of the outer stent 540 to the valve annulus MVA, so that when implanting the artificial heart valve, it is not necessary to deform the top section 546 of the outer stent 540 or only a small amount of deformation of the top section 546 of the outer stent 540 is required to adapt to the valve annulus MVA.

[0115] Preferably, the radial distance L2 between the outflow end and the inflow end of the top section 546 is less than the radial distance L3 between the outflow end of the top section 546 and the inner main body section 31, which keeps a radial gap 560 between the top section 546 and the inner main body section 31 to prevent the inner stent 30 of the implanted artificial heart valve 100 from being squeezed by the outer stent 540 and deformed, thereby further reducing the possibility of paravalvular leakage.

[0116] Reference Figures 23 to 25 , the artificial heart valve of Embodiment VII of the present invention is similar to the artificial heart valve 100 of Embodiment I, and the same parts will not be described herein again. The main difference between the artificial heart valve of Embodiment VII of the present invention and the artificial heart valve 100 of Embodiment I is that: the diameters of the various parts of the top section 646 of the outer stent 640 of the artificial heart valve of Embodiment VII of the present invention are no longer the same. Instead, in this embodiment, the top section 646 of the outer stent 640 extends inward toward the central axis L of the outer stent 640 while extending axially toward the inner skirt section 32, and then extends outward away from the central axis L of the outer stent 640 to form a circumferential recess 647. That is, the axial cross-section of the top section 646 in this embodiment is generally in an "S" shape. The recess 647 helps the valve annulus MVA to better fit to the top section 646, improves the adaptability of the top section 646 to the valve annulus MVA, and thus improves the positioning stability of the artificial heart valve.

[0117] Reference Figure 26, an artificial heart valve replacement system according to an embodiment of the present invention includes an artificial heart valve 11 and a delivery device 12 for delivering the artificial heart valve 11. The artificial heart valve 11 can be the artificial heart valve of any of the foregoing embodiments. The artificial heart valve 11 has a delivery state after radial compression and a natural state after radial expansion, wherein Figure 26 Briefly shows the delivery state of the artificial heart valve 11. The natural state of the artificial heart valve 11 can refer to the illustrations of the artificial heart valves in any of the foregoing embodiments.

[0118] The delivery device 12 includes an outer sheath 120 and an inner core 121 disposed within the outer sheath 120, and the inner core 121 and the outer sheath 120 are relatively movable along the axial direction. The artificial heart valve 11 is received in a gap between a distal portion of the inner core 121 and a distal portion of the outer sheath 120 in a delivery state after radial compression. Preferably, a limit card slot 122 for receiving the limit rod 430 of the artificial heart valve 11 is provided at a distal portion of the inner core 121, and the shape of the limit card slot 122 is complementary to the shape of the limit rod 430 as described above.

[0119] During the operation, when the operator pulls the outer sheath 120 proximally or pushes the inner core 121 distally to initially release the artificial heart valve 11, since the limit rod 430 of the artificial heart valve 11 is tightly engaged with the limit card slot 122 of the inner core 121 under the restraint of the outer sheath 120, the artificial heart valve 11 can be effectively prevented from instantaneously falling off the inner core 121, thereby facilitating the operator to observe and adjust the position of the artificial heart valve 11 through medical imaging. When the artificial heart valve 11 is displaced to an ideal release position, the outer sheath 120 is further pulled proximally or the inner core 121 is pushed distally so that the outer sheath 120 no longer restrains the limit rod 430. At this time, the limit rod 430 falls off the limit card slot 122 under the radial expansion of the artificial heart valve stent itself, thereby completely releasing the artificial heart valve 11.

[0120] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that they can still modify the technical solutions described in the foregoing embodiments, or perform equivalent replacements on some or all of the technical features; and these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. An artificial heart valve stent, characterized in that, It includes an interconnected inner stent and outer stent; the outer stent includes an outer main body section and an outer skirt section extending from the outer main body section and located radially outside the outer main body section, wherein the outer skirt section is located between the inlet end and the outlet end of the outer main body section; the inner stent includes an inner main body section at least partially located within the outer main body section of the outer stent and an inner skirt section protruding radially outside the inner main body section from the inlet end of the inner main body section; wherein, the inner skirt section protrudes radially outside the inlet end of the outer main body section, and the outer skirt section, the inner skirt section, and the section of the outer main body section located between the outer skirt section and the inner skirt section together form a radially outwardly open accommodation space.

2. The artificial heart valve stent according to claim 1, wherein The inlet end of the outer main body section is freely suspended, and there is a radial gap between the section of the outer main body section located between the outer skirt section and the inner skirt section and the inner main body section.

3. The artificial heart valve stent according to claim 1, characterized in that, The outer main body section includes an outer mesh structure and an outer connection structure connected to the outlet end of the outer mesh structure, the inner main body section includes an inner mesh structure and an inner connection structure connected to the outlet end of the inner mesh structure, and the outer connection structure and the inner connection structure are connected to each other so that the outer stent connects the inner stent.

4. The artificial heart valve stent according to claim 3, wherein, The outer mesh structure includes three layers of corrugated rods connected in sequence along the axis, and each layer of corrugated rods is formed by connecting a plurality of struts end to end in the circumferential direction and has a plurality of crest portions and trough portions alternately distributed in the circumferential direction.

5. The artificial heart valve stent according to claim 3, characterized in that, The outer mesh structure includes a bottom section extending radially outward relative to the central axis of the outer stent and also extending toward the inner skirt section, and a top section further extending toward the inner skirt section from the inlet end of the bottom section.

6. The artificial heart valve stent according to claim 5, wherein, The outer skirt section extends radially outward relative to the central axis of the outer stent and also extends toward the inner skirt section from the intersecting part of the bottom section and the top section, and the range of the angle between the tangent line at the approximate middle part of the outer skirt section and the central axis of the outer stent is 30° to 90°.

7. The artificial heart valve stent according to claim 6, wherein The outer skirt section includes a plurality of circumferentially distributed support units, each support unit is substantially rod-shaped, and the end of the support unit is a blunt end.

8. The artificial heart valve stent according to claim 6, wherein The outer skirt section includes a plurality of circumferentially distributed support units, each support unit includes two support rods extending in an arc-shaped, bent or linear manner away from the axis of symmetry of the support unit; each support rod includes an opposite first end and second end, the first ends of the two support rods of each support unit are connected to each other, the second ends of the two support rods of each support unit are connected to the outer mesh structure, or the second ends of the two adjacent support rods of two adjacent support units are connected to each other so that the outer skirt section is formed into a continuous ring.

9. The artificial heart valve stent according to claim 8, wherein The outer skirt segment is covered with a protective film, which is formed into a continuous ring or includes a plurality of segments distributed at intervals along the circumferential direction, and each segment of the protective film covers a corresponding supporting unit.

10. The artificial heart valve stent according to any one of claims 3 to 9, characterized in that, The inner mesh structure is a hollow cylindrical structure formed by a plurality of support rods connected in an interlaced manner, and the inner mesh structure forms a plurality of crests and troughs alternately distributed along the circumferential direction at the inflow end and the outflow end thereof through the plurality of support rods.

11. The artificial heart valve stent according to claim 10, characterized in that, The inner skirt section is trumpet-shaped, and the inner skirt section extends radially outward from the inflow end of the inner mesh structure relative to the central axis of the inner bracket while gradually moving away from the inflow end of the inner mesh structure in the axial direction. The inclination angle of the end of the inner skirt section relative to the central axis of the inner bracket is smaller than the inclination angle of the initial end of the inner skirt section relative to the central axis of the inner bracket.

12. The artificial heart valve stent according to claim 11, wherein, The inner skirt section includes a plurality of inner skirt units distributed along the circumferential direction, each of the inner skirt units includes two support rods, the initial ends of the two support rods of each of the inner skirt units are directly or indirectly connected to a corresponding crest portion of the inflow end of the inner mesh structure, the ends of the two support rods of each of the inner skirt units are connected, and the two adjacent support rods of two adjacent inner skirt units are directly or indirectly connected to the same crest portion of the inflow end of the inner mesh structure.

13. The artificial heart valve stent according to claim 12, characterized in that, The inner bracket also includes a connecting section for connecting the inner skirt section and the inner mesh structure, the connecting section includes a plurality of connecting rods distributed at intervals along the circumferential direction, and the connecting rods transition in an arc shape from a corresponding crest portion of the inflow end of the inner mesh structure to the intersection of two corresponding adjacent inner skirt units.

14. The artificial heart valve stent according to claim 1, wherein It also includes a developing mechanism disposed on at least one of the outer support and the inner support, and the developing mechanism includes one or more developing points, developing sections, or developing rings.

15. The artificial heart valve stent according to claim 1, characterized in that, With respect to the inner bracket and the outer bracket, the inner skirt section is covered with a flow-blocking film.

16. An artificial heart valve, characterized in that, It comprises at least two artificial valve leaflets and an artificial heart valve stent as described in any one of claims 1 to 15; the artificial valve leaflets are fixedly connected to the inner main body section in the inner stent of the artificial heart valve stent; the edges of the at least two artificial valve leaflets are butted against each other in the circumferential direction; the artificial heart valve is used to replace a native mitral valve or a native tricuspid valve.

17. An artificial heart valve replacement system, characterized in that, It includes an artificial heart valve as described in claim 16 and a delivery device for delivering the artificial heart valve, the artificial heart valve has a delivery state after radial compression and a natural state after radial expansion, the delivery device includes an outer sheath tube and an inner core inserted into the outer sheath tube, the inner core and the outer sheath tube can move relative to each other along the axial direction, and the artificial heart valve is accommodated in the gap between the distal part of the inner core and the distal part of the outer sheath tube after radial compression.

Images