CN114831775A

CN114831775A - Artificial heart valve, stent thereof and artificial heart valve replacement system

Info

Publication number: CN114831775A
Application number: CN202210303123.7A
Authority: CN
Inventors: 张庭超; 徐澧; 李阳
Original assignee: Hangzhou Valgen Medtech Co Ltd
Current assignee: Hangzhou Valgen Medtech Co Ltd
Priority date: 2020-12-21
Filing date: 2020-12-21
Publication date: 2022-08-02
Also published as: CN112603598A; CN112603598B

Abstract

The invention discloses a prosthetic heart valve stent, a prosthetic heart valve and a prosthetic heart valve replacement system. The artificial heart valve support comprises an inner support and an outer support which are connected with each other; the outer stent includes an outer body section and an outer skirt section extending from the outer body section and located radially outward of the outer body section, the outer skirt section being located between the inflow end and the outflow end of the outer body section; the inner stent includes an inner body section located at least partially within the outer body section of the outer stent, and an inner skirt section protruding radially outward of the inner body section from an inflow end of the inner body section; the inner skirt section protrudes outward from the radial outer side of the inflow end of the outer body section, and the outer skirt section, the inner skirt section and the section of the outer body section located between the outer skirt section and the inner skirt section together form a containing space which is opened radially outward. The artificial heart valve stent can reduce damage to valve annulus tissue.

Description

Artificial heart valve, stent thereof and artificial heart valve replacement system

Technical Field

The invention relates to the technical field of medical equipment, in particular to a prosthetic heart valve stent, a prosthetic heart valve with the prosthetic heart valve stent and a replacement system for the prosthetic heart valve.

Background

Heart valves play an important one-way "valve" role in the blood circulation activity of the heart to prevent regurgitation of blood. The mitral valve, which prevents regurgitation of blood from the Left Ventricle (LV) to the Left Atrium (LA), and the tricuspid valve, which prevents regurgitation of blood from the Right Ventricle (RV) to the Right Atrium (RA), are important heart valves, typically including the annulus, leaflets, chordae tendinae, and papillary muscles. The normal mitral or tricuspid leaflets close tightly when the ventricle is in a contracted state to completely block the regurgitation of blood from the ventricle into the atrium, while the diseased mitral or tricuspid leaflets often fail to close tightly to cause Mitral Regurgitation (MR) or Tricuspid Regurgitation (TR).

In order to treat patients with heart valve disorders, particularly severe heart valve disorders, prosthetic heart valves have been implanted in recent years by minimally invasive intervention procedures into the native mitral or tricuspid valve of the heart to replace the diseased native valve. Prosthetic heart valves typically include a stent for positioning at the native mitral or tricuspid valve of the heart and prosthetic leaflets disposed within the stent that act as one-way "valves" to prevent regurgitation of blood. When the existing artificial heart valve is implanted into an in-situ mitral valve or tricuspid valve of a heart, barbs on a bracket of the existing artificial heart valve penetrate into an annulus so as to achieve the purpose of positioning the artificial heart valve.

However, such prosthetic heart valves, which are positioned by the barbs penetrating the annulus, tend to cause damage to the annulus, and such damage is exacerbated as the heart beats dynamically.

Disclosure of Invention

It is an object of the present invention to provide a prosthetic heart valve holder, a prosthetic heart valve having the same, and a replacement system for the prosthetic heart valve, which may reduce, or at least to some extent, damage to the annulus tissue.

To this end, in one aspect, the present invention provides a prosthetic heart valve stent comprising an inner stent and an outer stent connected to each other; the outer bolster includes an outer body section, and an outer skirt section extending from and radially outward of the outer body section, wherein the outer skirt section is located between an inflow end and an outflow end of the outer body section; the inner stent includes an inner body section located at least partially within the outer body section of the outer stent, and an inner skirt section protruding radially outward of the inner body section from an inflow end of the inner body section; the inner skirt section protrudes outwards from the radial outer side of the inflow end of the outer body section, and the outer skirt section, the inner skirt section and the section of the outer body section located between the outer skirt section and the inner skirt section together form a containing space which is opened outwards in the radial direction.

In another aspect, the present invention provides a prosthetic heart valve, including at least two prosthetic leaflets and the prosthetic heart valve stent; the artificial valve leaflet is fixedly connected with the inner main body section in the inner main body section of the inner support of the artificial heart valve support; the edges of at least two pieces of artificial valve leaflets are butted with each other in the circumferential direction; the prosthetic heart valve is used to replace a native mitral valve or a native tricuspid valve.

In another aspect, the present invention provides a prosthetic heart valve replacement system, including the above prosthetic heart valve and a delivery device for delivering the prosthetic heart valve, wherein the prosthetic heart valve has a radially compressed delivery state and a radially expanded natural state, the delivery device includes an outer sheath and an inner core disposed in the outer sheath, the inner core and the outer sheath are axially movable relative to each other, and the prosthetic heart valve is accommodated in a gap between a distal end portion of the inner core and a distal end portion of the outer sheath after being radially compressed.

The outer skirt section positioned at the radial outer side of the outer body section, the inner skirt section protruding out of the radial outer side of the inner body section and the section of the outer body section positioned between the outer skirt section and the inner skirt section form an accommodating space which is opened outwards along the radial direction. When the artificial heart valve support is implanted into a heart, the valve ring tissue can be accommodated in the accommodating space, the section, located between the outer skirt edge section and the inner skirt edge section, of the outer main body section radially supports the valve ring tissue, the outer skirt edge section is blocked by the valve ring tissue to prevent the artificial heart valve support from shifting to the atrium side, the inner skirt edge section is blocked by the valve ring tissue to prevent the artificial heart valve support from shifting to the atrium side, and therefore the artificial heart valve support is positioned without the need of penetrating the valve ring with barbs to realize the positioning of the artificial heart valve support like the prior art, and therefore damage to the valve ring tissue can be reduced to a certain extent at least.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings needed to be used in the description of the embodiments or the prior art will be briefly introduced below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to these drawings without creative efforts.

Fig. 1 is a schematic perspective view of a prosthetic heart valve according to a first embodiment of the present invention;

FIG. 2 is a front view of the prosthetic heart valve of FIG. 1;

FIG. 3 is an exploded view of the prosthetic heart valve of FIG. 1;

FIG. 4a is a schematic view of the prosthetic heart valve of FIG. 1 implanted in a human heart, wherein the prosthetic leaflet and the occluding membrane of the prosthetic heart valve are not shown;

FIG. 4b is a partial enlarged view of FIG. 4 a;

FIG. 4c is a schematic view of the prosthetic heart valve of FIG. 4a mated to an annulus;

FIG. 5 is a front view of a prosthetic heart valve holder of the prosthetic heart valve of FIG. 1, with the flow-blocking membrane not shown;

FIG. 6 is a front view of an inner stent of the prosthetic heart valve stent of FIG. 5;

FIG. 7 is a front view of an outer stent of the prosthetic heart valve stent of FIG. 5;

FIG. 8a is a top view of the outer body section of the external bolster shown in FIG. 7;

FIG. 8b shows another variation of the outer body section similar to that shown in FIG. 8 a;

FIG. 9a is a front view of a stop bar of the external bolster shown in FIG. 7;

FIG. 9b shows another variation of a spacing rod similar to that shown in FIG. 9 a;

FIG. 9c shows a further variation of a spacing rod similar to that shown in FIG. 9 a;

FIG. 10a is an enlarged view of a portion of the external bolster of FIG. 7 showing the bolster unit consisting of two bolster rods;

figure 10b shows another variant of the racking unit similar to that of figure 10 a;

figure 10c shows a further variant of the racking unit similar to that of figure 10 a;

figure 10d shows a further variant of the racking unit similar to that of figure 10 a;

figure 11a shows another variant of the racking unit similar to that of figure 10a, wherein the racking unit is generally rod-shaped;

figure 11b shows another variant of the racking unit similar to that of figure 11 a;

figure 11c shows a further variant of the racking unit similar to that of figure 11 a;

figure 11d shows a further variant of the racking unit similar to that of figure 11 a;

FIG. 12 is a front view of an outer stent of a prosthetic heart valve according to a second embodiment of the present invention;

FIG. 13a is a partial enlarged view of FIG. 12;

FIG. 13b shows another variation of the developing mechanism like that in FIG. 13 a;

FIG. 13c shows a further modification of the developing mechanism like that in FIG. 13 a;

FIG. 14a is a front view of an outer stent of a prosthetic heart valve according to a third embodiment of the present invention;

fig. 14b shows another variant of the external bolster similar to that shown in fig. 14 a;

FIG. 15 is a front view of an outer stent of a prosthetic heart valve according to a fourth embodiment of the present invention;

fig. 16 is an exploded view of the external bolster shown in fig. 15;

FIG. 17 is a front view of a prosthetic heart valve according to a fifth embodiment of the present invention;

FIG. 18 is an exploded view of the prosthetic heart valve of FIG. 17;

FIG. 19 is a schematic view of the prosthetic heart valve of FIG. 17 mated to an annulus;

fig. 20 is a front view of a prosthetic heart valve stent for a prosthetic heart valve according to a sixth embodiment of the present invention, wherein a flow blocking membrane is not shown;

FIG. 21 is a front view of an outer stent of the prosthetic heart valve stent of FIG. 20;

FIG. 22 is a schematic view of the prosthetic heart valve holder of FIG. 20 mated with the valve annulus;

fig. 23 is a front view of a prosthetic heart valve stent of a prosthetic heart valve according to a seventh embodiment of the present invention, in which a flow blocking membrane is not shown;

FIG. 24 is a front view of an outer stent of the prosthetic heart valve stent of FIG. 23;

FIG. 25 is a schematic view of the prosthetic heart valve holder of FIG. 23 mated to the valve annulus;

fig. 26 is a schematic view of a prosthetic heart valve replacement system according to an embodiment of the present invention.

Detailed Description

In order to make the objects, 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 drawings in the embodiments of the present invention, and it is obvious that the described embodiments are some, but not all, embodiments of the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention. Moreover, the following described embodiments may be combined without contradiction or conflict, and some of the same or similar concepts or processes may not be described again in some embodiments.

Firstly, according to the blood flow direction in the ventricular diastole state, defining an inflow end and an outflow end of the artificial heart valve stent and each component thereof, the artificial heart valve and each component thereof, wherein the inflow end is close to the blood inflow side or the atrium side; the "outflow end" refers to an end near the blood outflow side or near the ventricular side.

"axial" means a direction parallel to a line connecting the center of the outflow end and the center of the inflow end. "radial" refers to a direction perpendicular or substantially perpendicular to the axial direction. "circumferential" refers to a direction around the axial direction. "central axis" means the line connecting the center of the outflow end to the center of the inflow end. "above," "upper layer," or "top" or similar terms refer to an orientation near the inflow end. "lower", "lower layer" or "bottom" or similar terms refer to an orientation near the outflow end. "radially outward" is the side radially away from the central axis. "radially inward" is the side radially closer to the central axis.

"inner"/"outer" is a set of relative concepts that mean that one feature or the entirety of a component in which that feature is located is at least partially radially inward/radially outward of another feature or the entirety of a component in which that other feature is located.

"initial end" refers to the attached end of a feature for connection to its adjacent feature. "terminal" refers to the end of a feature opposite its initial end, and in some cases also the "free end".

"proximal" refers to the end of a device or element near the operator. "distal" refers to the end of a device or element away from the operator.

It is noted that the terms indicating orientation or positional relationship, etc. described above are merely for convenience in describing the present invention and for simplicity in description, and do not indicate or imply that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore should not be construed as limiting the present invention.

Referring to fig. 1 to 3, a prosthetic heart valve 100 according to a first embodiment of the present invention includes a prosthetic heart valve stent 10, and at least two prosthetic leaflets 20 disposed in the prosthetic heart valve stent 10. The prosthetic heart valve stent 10 includes an inner stent 30 and an outer stent 40 connected to each other. Preferably, the inner support 30 is coaxially arranged within the outer support 40. In other words, the central axis of the inner stent 30 described herein coincides with the central axis of the outer stent 40, both denoted herein by L.

It is noted that the prosthetic heart valve stent 10 of the present invention has a radially compressed delivery state and a radially expanded natural state. In a delivery state, the artificial heart valve stent 10 is radially compressed by external force, so that the artificial heart valve stent can be compressed and arranged in a sheath tube with a smaller radial size, and then is delivered to the heart through the delivery device. In the natural state, the artificial heart valve stent 10 is not affected by external force and is radially and naturally deployed, and the structural features of the artificial heart valve stent 10 in the natural state are described below as no special description exists.

The outer carrier 40 includes an outer body section 41, and an outer skirt section 42 extending from the outer body section 41 and located radially outward of the outer body section 41, wherein the outer skirt section 42 is located between an inflow end 410 and an outflow end 411 of the outer body section 41.

The inner carrier 30 comprises an inner body section 31 at least partially located inside the outer carrier 40, and an inner skirt section 32 protruding radially outward of the inner body section 31 from the inflow end 310 of the inner body section 31, and the inner skirt section 32 further protrudes radially outward of the inflow end 410 of the outer body section 41, so that the inner skirt section 32 and the outer skirt section 42, and the section of the outer body section 41 located between the outer skirt section 42 and the inner skirt section 32 together form a radially outwardly open receiving space 50.

It is noted that as previously mentioned, "inner"/"outer" is a set of relative terms, meaning that one feature or the entirety of the component in which that feature is located at least partially radially inward/outward of another feature or the entirety of the component in which that other feature is located, and thus, the aforementioned inner skirt section 32 is not meant to be located radially inward of the outer skirt section 42, but rather the entirety of the inner support 30 in which the inner skirt section 32 is located at least partially radially inward of the entirety of the outer support 40 in which the outer skirt section 42 is located.

In this embodiment, the at least two artificial leaflets 20 are disposed in the inner body section 31 and fixedly connected to the inner body section 31 (e.g., by suturing), and the edges of the at least two artificial leaflets 20 are butted against each other in the circumferential direction. The material of the artificial valve leaflet 20 is preferably a biological tissue material such as bovine pericardium and porcine pericardium, and may also be a polymer material such as ultra-high molecular weight polyethylene.

With reference to fig. 4a to 4c, the prosthetic heart valve 100 is implanted into the native valve of the heart to be replaced, for example at the mitral valve MV between the left atrium LA and the left ventricle LV, with the respective annulus MVA received in said receiving space 50 of the prosthetic heart valve holder 10, thereby positioning the prosthetic heart valve 100. When the left ventricle LV is in a compressed state, the at least two artificial leaflets 20 close tightly to prevent backflow of blood from the left ventricle LV to the left atrium LA; when the left ventricle LV is in the expanded state, the at least two artificial leaflets 20 open to allow blood to flow from the left atrium LA into the left ventricle LV.

It is obvious that, in the prosthetic heart valve 100 of the present embodiment, the accommodating space 50 of the holder 10 accommodates the valve annulus MVA, the section of the outer body section 41 of the prosthetic heart valve holder 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 prosthetic heart valve holder 10 from displacing towards the atrium side, and the inner skirt section 32 is blocked by the valve annulus MVA to prevent the prosthetic heart valve holder 10 from displacing towards the ventricle side, so as to position the prosthetic heart valve 100, without puncturing the valve annulus MVA to position the prosthetic heart valve holder as in the prior art, thereby reducing damage to the valve annulus MVA.

It is to be appreciated that the prosthetic heart valve 100 can be implanted within the heart using minimally invasive intervention procedures. For example, the delivery device (described in detail below) may be used to house the prosthetic heart valve 100 after radial compression, and then deliver and release the prosthetic heart valve 100 to the vicinity of the mitral valve via transapical, transatrial, or transfemoral-superior vena cava-right atrium-interatrial septum-left atrium approaches to replace the diseased native valve.

Alternatively, the prosthetic heart valve 100 may be implanted directly into the heart by other means, such as surgery, to replace the diseased native valve.

It will also be appreciated that the use of the prosthetic heart valve 100 as shown in figures 4 a-4 c for replacing a diseased native mitral valve is shown by way of example only. In other embodiments, the prosthetic heart valve 100 can also be used to replace other suitable native valves, such as the tricuspid valve.

Referring to fig. 3, 5 and 6, in the present embodiment, the inner body section 31 of the inner support 30 is substantially in the shape of a hollow cylinder with two open ends. Preferably, the outer diameter of the inner body section 31 ranges from 25mm to 30 mm. Also preferably, the inner body section 31 is covered with a flow-blocking film 311. The material of the flow blocking film 311 is preferably PET, PTFE, or the like.

In this embodiment, the inner body section 31 includes an inner mesh 33 formed by a plurality of struts 312 connected in a staggered manner. The inner mesh structure 33 is formed by a plurality of layers of inner ring-shaped units 330 (e.g., two layers of inner ring-shaped

units

330A, 330B shown in fig. 6) arranged along the axial direction, each layer of inner ring-shaped units 330 is formed by a plurality of cells 331 arranged along the circumferential direction, wherein each cell 331 is enclosed by a plurality of struts 312 and has an opening 332. Preferably, each inner ring-shaped unit 330 is formed by a plurality of diamond-shaped unit cells 331 arranged along the circumferential direction, wherein a plurality of struts 312 of the upper ring-shaped unit 330A close to the inflow end 310 of the inner main body section 31 form a plurality of wave crest portions 314A and wave trough portions 314B alternately distributed along the circumferential direction, and a plurality of struts 312 of the lower ring-shaped unit 330B close to the outflow end 313 of the inner main body section 31 form a plurality of wave crest portions 315A and wave trough portions 315B alternately distributed along the circumferential direction.

In this embodiment, the inner body section 31 further comprises an inner connecting structure 35 disposed at the outflow end of the inner mesh structure 33 for connecting the outer stent 40 (the corresponding connecting structure of the outer stent 40 will be described below). In this embodiment, the inner connecting structure 35 includes a plurality of inner connecting units 350 arranged at intervals along the circumferential direction. Each trough portion 315B of the outflow end of the inner mesh structure 33 is connected to an inner connection unit 350. In this embodiment, each inner connecting unit 350 is substantially rod-shaped, extending axially downward from a corresponding trough portion 315B of the outflow end of the inner mesh structure 33, and is enlarged at its distal end so as to form an inner connecting hole 351 extending radially therethrough.

In the present embodiment, the inner skirt section 32 of the inner support 30 is generally flared. 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 film 320 is preferably PET, PTFE, or the like. Preferably, the inner skirt section 32 extends outwardly from the inflow end 310 of the inner body section 31 away from the central axis L of the inner support 30 while also extending axially away from the inflow end 310 of the inner body section 31. The inner skirt section 32 extends generally obliquely upwardly and outwardly as viewed in fig. 6.

Preferably, the angle a1 between the initial end 321 of the inner skirt section 32 (i.e. the end close to the inner body section 31, also called the connecting 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 in the range of 45 ° to 90 °, so that the inner skirt section 32 can better adapt to the structure of the valve annulus MVA, and the possibility of perivalvular leakage is reduced. Preferably, the inclination angle a2 of the terminal end 322 (i.e. the end away from the inner body section 31, also the free end) of the inner skirt section 32 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, so that the inner skirt section 32 can better conform to the MVA valve annulus, further improving the positioning stability of the prosthetic heart valve stent 10 and reducing the possibility of paravalvular leakage.

Preferably, the diameter D1 of the end 322 of the inner skirt section 32 ranges from 40mm to 70mm, which is about 10mm larger than the inner diameter of the conventional native annulus MVA, which effectively prevents the prosthetic heart valve 100 from shifting to the ventricular side and reduces the possibility of paravalvular leakage.

Optionally, the inner skirt section 32 of the inner stent 30 comprises a plurality of circumferentially distributed inner skirt units 323. Each inner skirt unit 323 comprises two struts 324, wherein the initial ends 321 of the two struts 324 are connected directly or indirectly to a respective peak portion 314A of the inflow end of the inner mesh 33, and the ends 322 of the two struts 324 are connected. The angle a3 between the two struts 324 of each inner skirt unit 323 preferably ranges from 30 ° to 150 °. Preferably, the two struts 324 of each inner skirt unit 323 are directly or indirectly connected to two adjacent crest portions 314A at the inflow end of the inner mesh structure 33. More preferably, two adjacent struts 324 of two adjacent inner skirt units 323 of said inner skirt section 32 intersect, i.e. correspond to the same crest portion 314A of the inflow end of the inner mesh 33. The angle a4 between two adjacent struts 324 of two adjacent inner skirt units 323 preferably ranges from 30 ° to 150 °. It can be seen that the crest portions 314A of the inflow end of the inner mesh 33 are each directly or indirectly connected to a respective strut 324 of the inner skirt section 32. It will be appreciated that in other embodiments, the inner skirt section 32 may take on other configurations, so long as it is capable of supporting the atrial side of the annulus MVA.

Preferably, the inner support 30 further comprises a connecting section 36 for connecting the inner skirt section 32 and the inner 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, or the like. In this embodiment, the connecting section 36 includes a plurality of circumferentially spaced connecting rods 361. 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 crest portion 314A of the inflow end of the inner mesh 33 of the inner body section 31. Preferably, said connecting rods 361 transition arcuately from a respective crest 314A at the inflow end of the inner mesh 33 to the intersection of the respective two adjacent inner skirt units 323, so as to avoid breakage of the connecting rods 361.

Alternatively, the inner skirt section 32, the inner body section 31, and the connecting section 36 may be separately formed and then the inner skirt section 32 and the inner body section 31 are connected by the connecting section 36 (e.g., by crimping, riveting, welding, stitching, or the like).

Preferably, the inner skirt section 32, the inner body section 31, and the connecting section 36 are integrally formed. In other words, the inner support 30 is preferably a one-piece member.

Alternatively, the inner stent 30 or each portion of the inner stent 30 is formed into a desired shape by laser cutting a tube material having a shape memory function such as a nickel titanium tube and performing a heat setting process. Alternatively, the inner stent 30 or each part of the inner stent 30 may be formed into a desired shape by braiding a wire material having a shape memory function such as a nitinol wire and performing a heat setting process.

Referring to fig. 3, 5 and 7, in the present embodiment, the inflow end 410 of the outer body section 41 of the outer stent 40 is free to hang, and a section of the outer body section 41 located between the outer skirt section 42 and the inner skirt section 32 (which supports the valve annulus tissue in a radial direction, which may be referred to as a support section) has a radial gap 60 with the inner body section 31. The radial distance L1 of the radial gap 60 preferably ranges from 1mm to 18mm, more preferably from 5mm to 18 mm. The radial gap 60 is designed to space the support section on the outer support 40 from the inner main body section 31 of the inner support 30 in the radial direction, when the outer support 40 of the heart valve prosthesis 100 which has been implanted into the heart is deformed inward by the radial compression of the valve annulus MVA, the radial gap 60 provides sufficient deformation space for the support section on the outer support 20, so that the outer support 40 is deformed by the radial compression of the valve annulus and does not affect the inner skirt section 32 of the inner support 30, thereby avoiding the gap between the inner skirt section 32 and the atrial side of the valve annulus due to the deformation of the outer support 40, and meanwhile, the inner skirt section 32 is covered with the flow-blocking membrane 320, which can effectively isolate the atrium from the ventricle, ensure the sealing performance of the atrial side and reduce the perivalvular leakage risk.

In this embodiment, the outer body section 41 of the outer stent 40 comprises an outer mesh 44 formed by a plurality of struts 412 connected in a staggered manner. The outer mesh 44 includes a bottom section 45 extending outwardly away from the central axis L of the outer stand 40 while also extending toward the inner skirt section 32, and a top section 46 extending from an inflow end of the bottom section 45 further toward the inner skirt section 32.

In this embodiment, the bottom section 45 is generally funnel-shaped, tapering from its inflow end 450 toward its outflow end 451 toward the central axis L of the outer bracket 40. The greater the angle of convergence, i.e. the greater the degree of inclination towards the central axis L of the outer support 40, the shorter the axial length of the bottom section 45; conversely, the smaller the angle of convergence, i.e., the degree of inclination toward the central axis L of outer bracket 40, the longer the axial length of bottom section 45. To reduce the overall height of the outer support 40, the angle a5 formed by two diametrically opposite tangents to the outflow end 451 of the bottom section 45 is preferably in the range of 90 ° to 150 °.

Referring to fig. 3, 5, 7 and 8a, in the present embodiment, the top section 46 is substantially in the shape of a hollow cylinder with two open ends, and the shape of the outer circumferential profile thereof is "O", which helps to simplify the manufacturing process of the external frame 40. In other words, the top section 46 in this embodiment is generally uniform in diameter throughout. Preferably, the diameter D2 of the top section 46 ranges from 30mm to 60mm, which is comparable to the inner diameter of the native valve annulus MVA, helping the valve annulus MVA to stably radially compress the top section 46.

Referring to fig. 8b, in other embodiments, the circumferential outer contour of the top section 146 may also take other shapes, such as a "D" shape, which helps the top section 146 to better conform to the structure of the native annulus MVA, avoiding compression of the ventricular outflow tract.

Referring again to fig. 3, 5 and 7, in the present embodiment, the outer mesh structure 44 of the outer body section 41 is formed by a plurality of outer annular units 440 arranged axially, each outer annular unit 440 is formed by a plurality of cells 441 arranged circumferentially, wherein each cell 441 is surrounded by a plurality of struts 412 and has an opening 442.

Preferably, the outer mesh structure 44 of the outer body section 41 has a lower resistance to deformation than the inner mesh structure 33 of the inner body section 31, so that the outer stent 40 can better conform to the native annulus MVA while also making the inner stent 30 sufficiently resistant to the pulling forces of the prosthetic leaflet 20 to resist deformation. The deformation resistance refers to the deformation resistance against external stress, and under the same stress, the higher the deformation resistance, the smaller the deformation amplitude, and vice versa. This may be achieved, for example, by making the area of the openings 442 of the cells 441 of the outer mesh structure 44 larger than the area of the openings 332 of the cells 331 of the inner mesh structure 33. It will be appreciated that in other embodiments, the inner body section 31 may have a higher resistance to deformation than the outer body section 41, for example, by selecting materials of different hardness, different strut sizes, etc., it being understood that the greater the hardness of the material, the higher the resistance to deformation, and the greater the strut size, the higher the resistance to deformation.

In this embodiment, the outer mesh structure 44 is formed by two layers of outer annular cells 440 arranged in a staggered manner, such that one cell 441 of each outer annular cell 440 is adjacent to two adjacent cells 441 of another adjacent outer annular cell 440. Preferably, the area of the openings 442A of the cells 441A, which mainly form the upper outer annular unit 440A of said top section 46, is larger than the area of the openings 442B of the cells 441B, which mainly form the lower outer annular unit 440B of said bottom section 45, so that the deformation resistance of the top section 46 is lower than the deformation resistance of the bottom section 45. This not only increases the flexibility of the top section 46, thereby enhancing the adaptation of the top section 46 to the valve annulus MVA, but also makes the bottom section 45 less prone to deformation and retains its shape. It will be appreciated that in other embodiments, the top section 46 may be made less resistant to deformation than the bottom section 45, for example by selecting materials of different hardness, different strut sizes, etc., it being understood that the greater the hardness of the material, the greater the resistance to deformation, and the greater the strut size, the greater the resistance to deformation.

In this embodiment, each of the outer annular units 440 is formed by a plurality of diamond-shaped cells 441 arranged in a circumferential direction, that is, each of the outer annular units 440 is formed by two layers of corrugated rods 443 connected in an axial direction, wherein each layer of corrugated rods 443 is formed by a plurality of struts 412 connected end to end in the circumferential direction, and has a plurality of wave crest portions 444A and wave trough portions 444B alternately distributed in the circumferential direction. The two layers of the outer ring units 440A, 440B share a middle corrugated rod 443B.

Preferably, the width of the struts 412 of the three-layer wave-shaped rod 443 of the outer mesh structure 44 (i.e., the distance between the two long sides of the radially inner side or the radially outer side of the struts 412) is gradually increased from the inflow end of the outer mesh structure 44 to the outflow end of the outer mesh structure 44, which helps to further improve the compliance of the tip section 46, thereby further enhancing the adaptation of the tip section 46 to the MVA of the annulus. More preferably, none of the struts 412 of the outer mesh structure 44 have a width greater than 0.5 mm. Optimally, the width of the struts 412 of the upper, middle and lower

corrugated bars

443A, 443B, 443C of the outer mesh structure 44 is 0.3mm, 0.4mm, 0.5mm, respectively.

In this embodiment, the outer body section 41 of the outer stent 40 further comprises an outer connecting structure 47 disposed at the outflow end of the outer mesh structure 44 for connecting with the inner connecting structure 35 of the inner stent 30. The outer connecting structure 47 includes a plurality of outer connecting units 470 arranged at intervals along the circumferential direction. Preferably, each wave trough 444B of the outflow end of the outer mesh structure 44 is connected to an outer connecting unit 470. In this embodiment, each of the outer connecting units 470 has a substantially rod shape, extends axially downward from a corresponding wave trough portion 444B of the outflow end of the outer mesh structure 44, and is enlarged at its distal end so as to form an outer connecting hole 471 extending radially therethrough.

When the outer bracket 40 and the inner bracket 30 are coupled, the inner bracket 30 is placed into the outer bracket 40 such that the outer coupling holes 471 are aligned with the corresponding inner coupling holes 351, and then the outer bracket 40 and the inner bracket 30 are coupled by inserting coupling members, such as coupling pins, into the outer coupling holes 471 and the inner coupling holes 351. It will be appreciated that in other embodiments, other means, such as stitching, may be used to connect the outer stent 40 to the inner stent 30.

In this embodiment, the external frame 40 further comprises a limiting structure 43 disposed at the end of the external connection structure 47 for connecting with a conveying device (described in detail below). Optionally, the position-limiting structure 43 comprises at least one position-limiting rod 430 disposed at the end of the external connection unit 470. Referring to fig. 9a, in the present embodiment, the limiting rod 430 is substantially T-shaped, and includes a rod portion 431 for connecting with the external connection unit 470, and an engaging portion 432 formed by expanding from a distal end of the rod portion 431. In this embodiment, the engaging portion 432 of the stopper 430 has a substantially circular axial cross section. It will be appreciated that in other embodiments, the engaging portion may have other shapes. For example, as shown in fig. 9B, in some embodiments, the axial cross-section of the engaging portion 432B may be rectangular. In some embodiments, as shown in fig. 9C, the axial cross-section of the engaging portion 432C may be semicircular.

Referring again to fig. 3, 5 and 7, in this embodiment, the outer skirt section 42 of the outer stand 40 extends from a substantially central position of the outer body section 41 of the outer stand 40 outwardly away from the central axis L of the outer stand 40 and also extends toward the inner skirt section 32. The outer skirt section 42 extends generally obliquely upwardly and outwardly as viewed in fig. 7. Preferably, the outer skirt section 42 extends outwardly from where the top section 46 and the bottom section 45 meet. In other words, the outer skirt section 42 extends outwardly from the portion of the outer body section 41 having the largest diameter, and the supporting section of the outer body section 41 between the outer skirt section 42 and the inner skirt section 32 for forming the accommodating space 50 is the top section 46.

It will be appreciated that in other embodiments, the outer skirt section 42 may extend outwardly from other portions of the outer body section 41, such as from a portion of the top section 46 adjacent the outflow end thereof. In this case, a partial section of the top section 46 is configured as a support section for forming an accommodation space.

Preferably, the minimum axial distance H between the inner skirt section 32 and the outer skirt section 42 is in the range of 5mm to 15mm, which is approximately equal to the thickness of the native valve annulus MVA, so that the valve annulus MVA can be stably clamped after being received in the receiving space 50 without a large gap causing the shaking of the prosthetic heart valve holder 10, and the positioning effect is better.

Preferably, the angle a6 between the initial end 421 of the outer skirt section 42 (i.e. the end close to the outer body section 41, also the connecting end) or the tangent to the initial end 421 of the outer skirt section 42 and the central axis L of the outer stand 40 is in the range of 60 ° to 120 °. The angle a7 between the end 422 of the outer skirt section 42 (i.e. the end remote from the outer body section 41, also the free end) or the tangent to the end 422 of the outer skirt section 42 and the central axis L of the outer carrier 40 ranges from 60 ° to 120 °.

Preferably, the outer skirt section 42 extends outwardly in an arc shape integrally with respect to the outer body section 41, and an included angle A8 between a tangent line of a substantially middle portion thereof and the central axis L of the outer bracket 40 ranges from 30 ° to 90 °, which facilitates the outer skirt section 42 to be expanded radially outwardly with a space for making an arc transition between the initial end 421 and the terminal end 422.

It is also preferred that the maximum outer diameter of the outer skirt section 42, in this embodiment the diameter D3 of the end 422 of the outer skirt section 42, is in the range of 40mm to 70mm, which is about 10mm larger than the inner diameter of a conventional native annulus MVA, which is effective in preventing the prosthetic heart valve 100 from being displaced to the atrial side.

Referring to fig. 7 and 10a, in the present embodiment, the outer skirt section 42 includes a plurality of circumferentially uniform and spaced bearer units 423. Each racking unit 423 includes two racking bars 424. Each support rod 424 includes a first end 425 distal from the outer body section 41 and connected to another support rod 424, and a second end 426 connected to the outer body section 41. In this embodiment, the second end 426 of each support rod 424 is attached to a substantially central portion of a corresponding strut 412 of the middle wave bar 443B. The first ends 425 of the two support rods 424 of each support element 423 are connected, preferably forming blunt ends, such as rounded, to reduce irritation and damage to the native annulus MVA. The second ends 426 of two adjacent support rods 424 of two adjacent racking units 423 are spaced apart. Preferably, two adjacent support rods 424 of two adjacent support units 423 are separated by one cell 441. It will be appreciated that in other embodiments, the outer skirt section 42 may take on other configurations so long as it supports the ventricular side of the annulus MVA.

For example, as shown in fig. 10B, in other embodiments, the two support rods 424B of the holder unit 423B may extend arcuately from their first ends 425B in a direction away from the axis of symmetry of the holder unit 423B (i.e., the axis between the two support rods 424B), which may increase the relative support area for the native annulus MVA. In other embodiments, as shown in fig. 10C, each support rod 424C of the support unit 423C may extend from its first end 425C in a direction away from the axis of symmetry of the support unit 423C. In other embodiments, as shown in fig. 10D, each support rod 424D of the holder unit 423D may extend linearly from its first end 425D away from the axis of symmetry of the holder unit 423D.

For another example, as shown in figure 11a, in other embodiments, each of the retainer units 423E of the outer skirt portion may no longer include two retainer bars 424. Instead, each of the seating units 423E may be substantially rod-shaped. Preferably, the distal end of each rod-shaped retainer unit 423E is formed as a blunt end extending arcuately outwardly relative to the outer body section 41. Preferably, each seating unit 423 extends outwardly from a corresponding valley 444B of the middle corrugated rod 443B or a corresponding peak 444A of the lower corrugated rod 443C.

For another example, as shown in fig. 11b, in other embodiments, the end of each rod-shaped holder member 423F may be formed as a blunt end having a rounded shape. In other embodiments, as shown in figure 11C, the distal end of each rod-like retainer element 423G may be formed as a blunt end in a general "C" shape. In other embodiments, as shown in fig. 11d, the distal end of each rod-shaped holder member 423H may be formed as a blunt end having a rectangular shape.

Alternatively, the outer skirt section 42, and the outer body section 41 are each separately formed, and then the outer skirt section 42 is connected to the outer body section 41 (e.g. by crimping, riveting, welding or stitching, etc.).

Preferably, the outer skirt section 42, and the outer body section 41 are integrally formed. In other words, the outer support 40 is preferably a single piece.

Alternatively, the outer stent 40 or each part of the outer stent 40 is formed into a desired shape by laser cutting a tube material having a shape memory function such as a nickel titanium tube and performing a heat setting process. Alternatively, the outer stent 40 or each part of the outer stent 40 may be formed into a desired shape by braiding wire materials having a shape memory function such as nitinol wires and performing a heat setting process.

Referring to fig. 12, the heart valve prosthesis according to the second embodiment of the present invention is similar to the heart valve prosthesis 100 according to the first embodiment, and the description of the same parts is omitted here. The main differences between the prosthetic heart valve of the second embodiment of the present invention and the prosthetic heart valve 100 of the first embodiment are: the outer frame 140 of the prosthetic heart valve according to the second embodiment of the present invention is further provided with a developing mechanism 48, so as to determine the actual position of the prosthetic heart valve when the prosthetic heart valve is implanted in vivo, especially when the prosthetic heart valve is implanted by a minimally invasive intervention operation. The material of the developing mechanism 48 may be tungsten, gold, platinum, tantalum, or the like, which is visible under X-rays.

As shown in fig. 12 and 13a, the visualization mechanism 48 of the heart valve prosthesis of the present embodiment includes a plurality of visualization points 480. The development point 480 may be secured to the inflow end of the outer housing 140, for example, by crimping. Preferably, the plurality of development sites 480 are evenly and spaced apart at a plurality of crest portions 444A at the inflow end of the top section 46 of the outer cradle 140. It is understood that in other embodiments, the plurality of visualization points may be disposed at other locations of the prosthetic heart valve stent. For example, a plurality of development sites 480 may also be provided on the inner skirt section 32 of the inner support 30. Alternatively, only one development point 480 may be provided.

In other embodiments, the developing mechanism may take other configurations. For example, as shown in fig. 13B, in other embodiments, the development mechanism may include a plurality of development segments 480B, each development segment 480B may be formed by a respective crest 444A of a length of development wire/thread secured, e.g., wound, to the inflow end of the top segment 46. For another example, as shown in fig. 13C, in other embodiments, the development mechanism may be configured as a continuous, complete development ring 480C, and the development ring 480C may be formed from a length of development wire/thread threaded, e.g., stitched, through a plurality of peaks 444A at the inflow end of the top section 46 and secured to the inflow end of the top section 46. It will be appreciated that in other embodiments, the development mechanism may be formed in a continuous, but incomplete, configuration, such as an arcuate, semi-circular configuration.

Referring to fig. 14a, the heart valve prosthesis of the third embodiment of the present invention is similar to the heart valve prosthesis 100 of the first embodiment, and the description of the same parts is omitted here. The main differences between the prosthetic heart valve of the third embodiment of the present invention and the prosthetic heart valve 100 of the first embodiment are: the outer skirt section 42 of the prosthetic heart valve according to the third embodiment of the present invention is covered with the protective film 427, so as 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, or the like. As can be seen, the protective film 427 in this embodiment is formed as a continuous ring. That is, the protective film 427 in the present embodiment covers not only all the holder units 423 but also the gaps between the adjacent holder units 423.

It is understood that in other embodiments, the protective film may take other configurations. For example, as shown in fig. 14B, in other embodiments, the protective film 427B may include a plurality of circumferentially spaced segments, each segment covering a corresponding holder element 423, which also prevents damage to the annulus MVA caused by the outer skirt segment 42.

Referring to fig. 15 and 16, a heart valve prosthesis according to a fourth embodiment of the present invention is similar to the heart valve prosthesis 100 according to the first embodiment, and the description of the same parts is omitted. The prosthetic heart valve of the fourth embodiment of the present invention is mainly different from the prosthetic heart valve 100 of the first embodiment in that: the outer skirt section 342 of the prosthetic heart valve of the fourth embodiment of the invention is configured as a continuous ring. In other words, in this embodiment, the first ends 3425 of two support rods 3424 of each support unit 3423 are connected, and the second ends 3426 of two adjacent support rods 3424 of two adjacent support units 3423 are also connected. Specifically, the first ends 3425 of the two support rods 3424 of each support unit 3423 extend outwardly to the radially outer side of the outer body section 41 and are connected, preferably forming a blunt end, such as a circular arc, to reduce the stimulation to the native annulus MVA. The second ends 3426 of the two support rods 3424 of each racking unit 3423 each extend inwardly to the radially inner side of the outer body section 41 and are connected to the second end 3426 of an adjacent racking rod 3424 of an adjacent racking unit 3423, also preferably forming a blunt end, such as a circular arc.

Preferably, the outer skirt section 342 and the outer body section 41 are formed separately in this embodiment, and then the outer skirt section 342 is connected to the outer body section 41 by means of, for example, sewing. Preferably, the outer skirt section 342 is formed into the desired shape by braiding nitinol wires and heat setting. The outer body section 41 is formed into the desired shape by laser cutting a nickel titanium tube and heat setting.

Referring to fig. 17 to 19, a prosthetic heart valve 500 according to a fifth embodiment of the present invention is similar to the prosthetic heart valve 100 according to the first embodiment, and the description of the same parts is omitted here. The prosthetic heart valve 500 of the fifth embodiment of the present invention is mainly different from the prosthetic heart valve 100 of the first embodiment in that: the outer main body section 41 of the outer stent of the prosthetic heart valve 500 according to the fifth embodiment of the present invention is also covered with the flow-blocking membrane 413. The material of the flow blocking film 413 is preferably PET, PTFE, or the like. 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, so that double-layer sealing is realized, the sealing effect of the artificial heart valve 500 is further enhanced, and the possibility of perivalvular leakage is reduced.

Referring to fig. 20 to 22, the heart valve prosthesis according to the sixth embodiment of the present invention is similar to the heart valve prosthesis 100 according to the first embodiment, and the description of the same parts is omitted here. The prosthetic heart valve of the sixth embodiment of the present invention is mainly different from the prosthetic heart valve 100 of the first embodiment in that: the diameters of the top section 546 of the outer stent 540 of the prosthetic heart valve of the sixth embodiment of the present invention are no longer uniform throughout. In contrast, the top section 546 of the outer bracket 540 in this embodiment extends axially toward the inner skirt section 32 while also extending inwardly toward the central axis L of the outer bracket 540. In other words, the diameter of the top section 546 of the outer stent 540 in this embodiment gradually decreases from the outflow end to the inflow end thereof, thereby forming a structure that gradually converges obliquely toward the central axis L of the outer stent 540. This helps to further improve the adaptation of the outer stent 540 to the valve annulus MVA, such that upon implantation of the prosthetic heart valve, the valve annulus MVA can be accommodated without deforming the top section 546 of the outer stent 540 or with only a small amount of deformation of the top section 546 of the outer stent 540.

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

Referring to fig. 23 to 25, the prosthetic heart valve according to the seventh embodiment of the present invention is similar to the prosthetic heart valve 100 according to the first embodiment, and the description of the same parts is omitted here. The prosthetic heart valve of the seventh embodiment of the present invention is mainly different from the prosthetic heart valve 100 of the first embodiment in that: the top section 646 of the outer stent 640 of the prosthetic heart valve of example seven of the present invention is no longer of uniform diameter throughout. In contrast, the top section 646 of the outer holder 640 in this embodiment extends first inwardly toward the central axis L of the outer holder 640 and then outwardly away from the central axis L of the outer holder 640 while extending axially toward the inner skirt section 32 to form a circumferential recess 647. That is, the axial cross-section of the top section 646 in this embodiment is generally "S" shaped. The recesses 647 facilitate better conformance of the valve annulus MVA to the top section 646, increasing the adaptability of the top section 646 to the valve annulus MVA, thereby increasing the positional stability of the prosthetic heart valve.

Referring to fig. 26, the prosthetic heart valve replacement system according to an embodiment of the present invention includes a prosthetic heart valve 11 and a delivery device 12 for delivering the prosthetic heart valve 11. The prosthetic heart valve 11 may be the prosthetic heart valve of any of the embodiments described above. The prosthetic heart valve 11 has a radially compressed delivery state and a radially expanded natural state, wherein fig. 26 schematically shows the delivery state of the prosthetic heart valve 11, and the natural state of the prosthetic heart valve 11 can be referred to the illustration of the prosthetic heart valve of any of the previous embodiments.

The conveying device 12 includes an outer sheath 120 and an inner core 121 disposed in the outer sheath 120, and the inner core 121 and the outer sheath 120 can move relatively in an axial direction. The prosthetic heart valve 11 is accommodated in a gap between the distal end portion of the inner core 121 and the distal end portion of the outer sheath 120 in a delivery state after being radially compressed. Preferably, the distal portion of the inner core 121 is provided with a stop notch 122 for receiving the stop rod 430 of the prosthetic heart valve 11, and the shape of the stop notch 122 is complementary to the shape of the stop rod 430 as described above.

In the operation process, when the operator pulls the outer sheath tube 120 towards the proximal end or pushes the inner core 121 towards the distal end to release the artificial heart valve 11 preliminarily, the limiting rod 430 of the artificial heart valve 11 is tightly matched with the limiting clamping groove 122 of the inner core 121 under the constraint of the outer sheath tube 120, so that the artificial heart valve 11 can be effectively prevented from falling off from the inner core 121 instantaneously, and the operator can observe and adjust the position of the artificial heart valve 11 through medical images. After the prosthetic heart valve 11 is displaced to the desired release position, the sheath 120 is further pulled proximally or the inner core 121 is pushed distally so that the sheath 120 no longer binds the limiting rod 430, and at this time, the limiting rod 430 falls off from the limiting slot 122 under the radial expansion of the prosthetic heart valve stent itself, thereby completely releasing the prosthetic heart valve 11.

Finally, it should be noted that: the above embodiments are only used to illustrate the technical solution of the present invention, and not to limit the same; while the invention has been described in detail and with reference to the foregoing embodiments, it will be understood by those skilled in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some or all of the technical features may be equivalently replaced; and the modifications or the substitutions do not make the essence of the corresponding technical solutions depart from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A heart valve prosthesis stent is characterized by comprising an inner stent and an outer stent which are connected with each other; the outer bolster includes an outer body section, and an outer skirt section extending from and radially outward of the outer body section, wherein the outer skirt section is located between an inflow end and an outflow end of the outer body section; the inner stent includes an inner body section located at least partially within the outer body section of the outer stent, and an inner skirt section protruding radially outward of the inner body section from an inflow end of the inner body section; the inner skirt section protrudes outwards from the radial outer side of the inflow end of the outer body section, and the outer skirt section, the inner skirt section and the section of the outer body section located between the outer skirt section and the inner skirt section form an accommodating space which is opened outwards along the radial direction.

2. The prosthetic heart valve stent of claim 1, wherein the inflow end of the outer body section is free-floating, and a section of the outer body section between the outer skirt section and the inner skirt section has a radial gap with the inner body section.

3. The prosthetic heart valve stent of claim 1, wherein the outer body section includes an outer mesh structure and an outer connecting structure connected to an outflow end of the outer mesh structure, and the inner body section includes an inner mesh structure and an inner connecting structure connected to an outflow end of the inner mesh structure, the outer and inner connecting structures being connected to each other such that the outer stent connects the inner stent.

4. The prosthetic heart valve stent of claim 3, wherein the outer mesh structure comprises a plurality of layers of corrugated bars connected in series along an axial direction, each layer of corrugated bars being formed by a plurality of struts connected end to end along a circumferential direction and having a plurality of wave crest portions and wave trough portions alternately distributed along the circumferential direction.

5. The prosthetic heart valve stent of claim 3, wherein the outer mesh structure comprises a bottom section extending radially outward relative to a central axis of the outer stent while also extending toward the inner skirt section, and a top section extending from an inflow end of the bottom section further toward the inner skirt section.

6. The prosthetic heart valve stent of claim 5, wherein the outer skirt segment extends from a point where the bottom segment and the top segment intersect radially outward relative to a central axis of the outer stent while also extending toward the inner skirt segment, and wherein a tangent to a substantially middle portion of the outer skirt segment includes an angle in a range of 30 ° to 90 ° with respect to the central axis of the outer stent.

7. The prosthetic heart valve stent of claim 6, wherein the outer skirt section comprises a plurality of circumferentially distributed struts, each of the struts being generally rod-shaped and terminating in a blunt end.

8. The prosthetic heart valve stent of claim 6, wherein the outer skirt section comprises a plurality of circumferentially distributed bolster units, each of the bolster units comprising two bolster rods extending arcuately, curvedly, or linearly; each bearing rod comprises a first end and a second end which are opposite, the first ends of the two bearing rods of each bearing unit are connected, the second ends of the two bearing rods of each bearing unit are connected with the outer net-shaped structure, or the second ends of the two adjacent bearing rods of the two adjacent bearing units are connected with each other to enable the outer skirt section to form a continuous ring.

9. The prosthetic heart valve stent of claim 8, wherein the outer skirt section is covered with a protective membrane formed as a continuous ring or comprising a plurality of circumferentially spaced segments, each segment of the protective membrane covering a respective retainer unit.

10. The stent as claimed in any one of claims 3 to 9, wherein the inner mesh structure is a hollow cylinder structure formed by a plurality of struts which are connected in a staggered manner, and the inner mesh structure forms a plurality of wave crest portions and wave trough portions alternately distributed in a circumferential direction at an inflow end and an outflow end of the inner mesh structure through the plurality of struts, respectively.

11. The prosthetic heart valve stent of claim 10, wherein the inner skirt section is flared, the inner skirt section extends radially outward from an inflow end of the inner mesh structure relative to a central axis of the inner stent while also tapering axially away from the inflow end of the inner mesh structure, and wherein an inclination angle of a terminal end of the inner skirt section relative to the central axis of the inner stent is less than an inclination angle of an initial end of the inner skirt section relative to the central axis of the inner stent.

12. The prosthetic heart valve stent of claim 11, wherein the inner skirt section comprises a plurality of circumferentially distributed inner skirt units, each inner skirt unit comprising two struts, wherein the initial ends of the two struts of each inner skirt unit are respectively connected directly or indirectly to a corresponding crest portion of the inflow end of the inner mesh structure, wherein the terminal ends of the two struts of each inner skirt unit are connected, and wherein two adjacent struts of two adjacent inner skirt units are connected directly or indirectly to the same crest portion of the inflow end of the inner mesh structure.

13. The prosthetic heart valve stent of claim 12, further comprising a connecting section for connecting the inner skirt section and the inner mesh structure, the connecting section comprising a plurality of circumferentially spaced connecting rods arcuately transitioning from a respective crest portion of an inflow end of the inner mesh structure to an intersection of respective two adjacent inner skirt units.

14. The prosthetic heart valve stent of claim 1, further comprising a visualization mechanism disposed on at least one of the outer stent and the inner stent, the visualization mechanism comprising one or more visualization points, visualization segments, or visualization rings.

15. The prosthetic heart valve stent of claim 1, wherein at least the inner skirt section is covered with a flow blocking membrane for the inner stent and the outer stent.

16. A prosthetic heart valve comprising at least two pieces of prosthetic valve leaflets and the prosthetic heart valve stent of any one of claims 1-15; the prosthetic valve leaflet is fixedly connected with the inner body section of the inner support of the prosthetic heart valve support; edges of the at least two artificial valve leaflets are butted against each other in the circumferential direction; the prosthetic heart valve is used to replace a native mitral valve or a native tricuspid valve.

17. A prosthetic heart valve replacement system comprising the prosthetic heart valve of claim 16 and a delivery device for delivering the prosthetic heart valve, the prosthetic heart valve having a radially compressed delivery state and a radially expanded natural state, the delivery device comprising an outer sheath and an inner core disposed within the outer sheath, the inner core and the outer sheath being axially movable relative to each other, the prosthetic heart valve being radially compressed and received in a gap between a distal end portion of the inner core and a distal end portion of the outer sheath.