Expandable prosthetic heart valve

Abstract

The present disclosure relates to a prosthetic heart valve for replacing a native heart valve, comprising: an annular stent comprising: a mesh structure as a circumferential sidewall of the stent; a leaflet structure, each leaflet attached to the stent and having a first portion disposed within the stent and a second portion turnup to an outer peripheral side of the proximal end of the stent. As the heart grows, the stent can be expanded after the prosthetic heart valve is anchored to the heart, allowing the prosthetic heart valve to operate in different conditions without being replaced, the edge end of the second portion of each leaflet being connected to the stent at a location between the distal and proximal ends of the stent without being secured to the proximal end of the stent, and the edge end of the second portion of each leaflet being connected to the stent at a location between the distal and proximal ends of the stent. In at least one state, each leaflet is sized beyond the mating size of the stent in that state and each leaflet has a redundant portion that is free to droop in a direction from the distal end to the proximal end to a location away from the stent, such that the dimensions allow the leaflet to be away from the stent to form a more functional valve.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an expandable artificial heart valve capable of working in different states. Background Art

[0002] Natural heart valves, such as the aortic, pulmonary, mitral, and tricuspid valves, are critical structures that ensure adequate and positive blood flow through the cardiovascular system. Congenital, inflammatory, or infectious diseases can reduce the effectiveness of these heart valves. Damage to these valves can lead to serious cardiovascular damage or even death, so it may eventually be necessary to replace the natural heart valve with an artificial heart valve, either surgically or through minimally invasive (transcatheter implantation) procedures.

[0003] According to the existing technology, after a traditional artificial heart valve is implanted to replace the corresponding natural valve, as the patient ages, if the size of the implanted artificial heart valve is no longer suitable and cannot expand (for example, the pulmonary artery artificial heart valve currently on the market is a non-expandable valve catheter), the patient needs to undergo invasive replacement surgery every few years, which causes great pain to the patient's body and also increases the pressure on medical expenses.

[0004] Therefore, it is desirable to provide a prosthetic heart valve that, after being anchored within the heart at an early stage, can expand to a certain extent to have an expanded size that matches the growth of the heart. Summary of the invention

[0005] In view of this, an object of the present disclosure is to provide an expandable artificial heart valve, which can expand to have an expanded radial size after being anchored to the heart, thereby allowing the artificial heart valve to work in different states without having to be replaced / removed during the patient's growth. The artificial heart valve provided according to the embodiment of the present disclosure can be used to replace the natural heart valve of a child (from about 18 months old), and can expand as the patient (e.g., child) grows, so that the patient does not need to frequently replace the implanted artificial heart valve through surgery or transcatheter intervention, thereby saving medical costs and reducing pain.

[0006] According to one aspect of the embodiments of the present disclosure, there is provided an artificial heart valve for replacing a natural heart valve, the artificial heart valve comprising:

[0007] An annular stent (100) has a distal end (1) and a proximal end (2) in the axial direction, and comprises: a mesh structure (110) as a circumferential side wall of the stent, wherein the mesh structure allows the stent to contract or expand in a radial direction; and

[0008] A leaflet structure (200) comprising a plurality of leaflets (210), each leaflet being attached to the stent and having a first portion (211) disposed within the stent and a second portion (212) rolled to the outer peripheral side of the proximal end of the stent,

[0009] Wherein, as the heart grows, the stent can be expanded to have an expanded radial size after the artificial heart valve is anchored in the heart, thereby allowing the artificial heart valve to operate in different states without being replaced, and the edge end of the second part of each leaflet is connected to the stent at a position between the distal end and the proximal end of the stent without being fixed to the proximal end of the stent. In at least one of the different states, the size of each leaflet exceeds the adaptation size of the stent in that state and each leaflet has a redundant part (210e) that freely hangs down in the direction from the distal end to the proximal end to a position away from the stent, so that the size of each leaflet allows the leaflet to move away from the stent to form a more functional valve.

[0010] In some optional embodiments, the artificial heart valve is used to replace the natural pulmonary valve. In some optional embodiments, the artificial heart valve can be used to replace the natural tricuspid valve.

[0011] In some optional embodiments, the stent further includes a plurality of struts (130) for attaching the plurality of leaflets, and each strut extends distally from the proximal end of the mesh structure, wherein the second portion of each leaflet is rolled up at the proximal end of the plurality of struts to the peripheral side of the stent at the proximal end.

[0012] In some optional embodiments, each of the leaflets is semicircular / quasi-semicircular in shape, having an arcuate edge corresponding to the second part and a free edge corresponding to the first part, the free edge being located at the distal end and extending between the two ends of the arcuate edge, the first parts of the multiple leaflets are arranged in the stent, the first parts of the multiple leaflets are in contact with each other in a closed state to inhibit blood from flowing through the artificial heart valve in a direction from the distal end to the proximal end, or are separated from each other in an open state to allow blood to flow through the artificial heart valve in a direction from the proximal end to the distal end, and the stent has a proximal contour that matches the arcuate edges of the multiple leaflets.

[0013] In some optional embodiments, the mesh structure includes a plurality of first mesh units (110a) and a plurality of second mesh units (110b) distributed along the circumferential direction, adjacent leaflets in the plurality of valves are connected to each other to form a commissure (20), the commissure (20) is attached to the corresponding second mesh units, and the two ends of the second part of each leaflet are respectively attached to two adjacent second mesh units. In some optional embodiments, the mesh units included in the mesh structure may have different shapes.

[0014] In some optional embodiments, the multiple first grid units are evenly divided into multiple first grid unit groups, each first grid unit group is composed of one or more first grid units continuously distributed along the circumference, and every two adjacent first grid unit groups are connected by a corresponding second grid unit.

[0015] In some optional embodiments, the plurality of struts are respectively connected to the corresponding first grid units at the proximal ends, and for each group of the first grid units, the length of the corresponding struts gradually decreases from the middle to both sides.

[0016] In some optional embodiments, each of the first grid units has a shuttle / diamond-shaped frame; the multiple first grid units have the same size; or every two adjacent grid units share a common frame edge extending from the distal end to the proximal end, and one of the every two adjacent grid units is the first grid unit or the second grid unit.

[0017] In some optional embodiments, the stent further includes a plurality of anchoring units (120), wherein the plurality of anchoring units (120) are arranged at intervals at the distal end of the mesh structure, and each of the anchoring units is used to anchor to a corresponding anchoring position of the heart.

[0018] In some optional embodiments, each of the plurality of first grid units and the plurality of second grid units has a distal frame edge, the distal frame edge has a first arch angle pointing distally, and each of the anchoring units is connected to the corresponding first arch angle; or each of the first grid units has a proximal frame edge, the proximal frame edge has a second arch angle pointing proximally, and each of the struts is connected to the corresponding second arch angle.

[0019] In some optional embodiments, each of the second grid units provides a concave frame edge at the proximal end to allow the second portion of the corresponding leaflet to be rolled over the concave frame edge to the peripheral side of the stent.

[0020] In some optional embodiments, the concave frame edge includes: a first connection point (A) at the proximal end, connected to an adjacent first grid unit; a second connection point (A') at the proximal end, connected to another adjacent first grid unit; a first frame line (11) and a second frame line (12), extending from the first connection point and the second connection point, respectively, to form a corner pointing to the distal end, wherein the second parts of the two adjacent leaflets are respectively rolled over to the peripheral side of the stent at the proximal end through the corresponding positions of the first frame line and the second frame line.

[0021] In some optional embodiments, the artificial heart valve further comprises a covering layer (300), the covering layer (300) being attached to the surface of the stent and connected to the second portion of each leaflet. In some embodiments, a single or multiple covering layers may be attached to the outer surface and / or the inner surface of the stent.

[0022] In some optional embodiments, the plurality of first grid units and the plurality of second grid units are completely covered by the covering layer; and the plurality of struts are at least partially covered by the second portion of the plurality of leaflets and / or the covering layer.

[0023] In some optional embodiments, the proximal portion of the covering layer is sandwiched between the stent and the second portion of the plurality of leaflets.

[0024] In some optional embodiments, the covering layer is sutured with the stent along each distal frame edge of the mesh structure and / or each proximal frame edge of the mesh structure, and the covering layer is a single-piece structure or a multi-piece structure. In some embodiments, the covering layers of the multi-piece structure can be connected or spliced ​​to each other.

[0025] In some optional embodiments, the covering layer has a plurality of openings (310) for allowing the covering layer to expand with the stent.

[0026] In some optional embodiments, each of the openings is a slit or a hole; the multiple openings are arranged in multiple columns, and each column of the openings extends from the distal end to the proximal end; or each of the first grid units corresponds in position to at least one of the openings.

[0027] In some optional embodiments, the plurality of struts respectively have a cavity (10) arranged at the proximal end, and the cavities of the plurality of struts are connected by sutures or threads to provide structural support for the plurality of leaflets.

[0028] In some optional embodiments, the covering layer is sutured and connected to the stent based on the lumens of the plurality of struts.

[0029] In some optional embodiments, the second portion of at least one of the leaflets is folded / pleated in multiple places on the peripheral side of the proximal end of the stent to form folds, which serve as a cushion to prevent leakage / reflux, and each fold extends along the strut to expand with the stent.

[0030] In some optional embodiments, the different states of the artificial heart valve include one or more of the following states: a first state, having a first radial dimension for replacing a natural valve during the implantation stage; a second state, having a second radial dimension that is adjusted by expansion according to the growth of the heart after the implantation stage; a third state, having a third radial dimension and serving as a docking adapter for a valve-in-valve surgery, wherein the second radial dimension is larger than the first radial dimension and smaller than the third radial dimension.

[0031] In some optional embodiments, the artificial heart valve is implanted into the heart through surgery or transcatheter intervention.

[0032] The artificial heart valve provided according to the embodiment of the present disclosure is used to replace the natural valve of the heart, and the artificial heart valve mainly includes: a stent and a leaflet structure, and the stent has a mesh structure as a circumferential side wall, so that the stent is expandable at least in the radial direction. As the heart grows, after the artificial heart valve is anchored to the heart, the stent can expand to have an expanded radial size, thereby allowing the artificial heart valve to work in different states without being replaced / removed. Based on this, after the artificial heart valve is implanted in the heart by surgery or transcatheter delivery, the artificial heart valve according to the embodiment of the present disclosure can maintain functionality (as a valve or as a docking adapter) during the growth of the patient (for example, from 18 months to 16+ years old or even to 18+ years old). Therefore, the patient does not need to frequently replace the implanted artificial heart valve by surgery or transcatheter delivery, saving medical expenses and reducing pain.

[0033] In some applications, the artificial heart valve according to the embodiments of the present disclosure is used to replace the natural pulmonary valve, can be implanted to treat pulmonary valve stenosis, and can prevent regurgitation after implantation if it is not replaced.

[0034] In some optional embodiments, the second portion of at least one leaflet has multiple folds / pleats on the peripheral side of the proximal end of the stent to form folds extending along the struts, so that it can expand with the stent. The multiple folds / pleats of the leaflet at the proximal end can be used as a cushion to prevent leakage / regurgitation.

[0035] In some optional embodiments, the artificial heart valve also includes a covering layer, which is attached to the peripheral side of the stent and connected to the second part of each leaflet to avoid calcification, stress concentration and durability caused by direct contact between the stent and the tissue. In some embodiments, the covering layer can be designed to have openings (e.g., slits, holes) to support further expansion of the stent. In some embodiments, the covering layer can be sutured to the stent along each distal frame edge of the mesh structure and / or each proximal frame edge of the mesh structure, thereby allowing the suture line on the opposite side to be not affected or pulled when the artificial heart valve is expanded.

[0036] In some optional embodiments, the different states of the artificial heart valve include one or more of the following states: a first state (for example, for children 18 months and older), having a first radial dimension for replacing a natural valve during the implantation stage; a second state, having a second radial dimension that is adjusted by expansion according to the growth of the heart after implantation; a third state, having a third radial dimension and serving as a docking adapter for a valve-in-valve surgery, wherein the second radial dimension is larger than the first radial dimension and smaller than the third radial dimension.

[0037] Those skilled in the art will recognize the above objects, other objects and advantages of various embodiments of the present invention after reading the following detailed description of the embodiments as illustrated in the various drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] The above and other objects, features and advantages of the present disclosure will become more apparent through the following description of embodiments of the present disclosure with reference to the accompanying drawings, in which:

[0039] Figure 1 is a schematic diagram of a cross section of the heart showing the location of the native valve;

[0040] Figure 2 is a schematic structural diagram of an artificial heart valve according to an embodiment of the present disclosure;

[0041] Figure 3 is a schematic structural diagram of a stent for an artificial heart valve according to an embodiment of the present disclosure;

[0042] Figure 4 is a schematic diagram of a leaflet structure according to an embodiment of the present disclosure;

[0043] Figure 5 is a flattened schematic diagram of the structure of a single leaflet according to an embodiment of the present disclosure;

[0044] Figure 6 is a schematic diagram of the positional relationship between the covering layer and the bracket according to an embodiment of the present disclosure;

[0045] Figure 7aIs the artificial heart valve in Figure 6 A schematic diagram of a cross-sectional structure of a support rod at a position along the radial direction of the support;

[0046] Figure 7b The artificial heart valve is in the expanded state at a branch position along the Figure 6 A schematic diagram of the cross-sectional structure of the bracket in the radial direction is shown;

[0047] Figure 8 Shown as Figure 6 , 7a and a schematic diagram of the structure of the covering layer shown in 7b;

[0048] Fig. 9 is a schematic diagram of a top view of the structure from the distal end to the proximal end of an artificial heart valve according to an embodiment of the present disclosure when the leaflet structure is in an open state;

[0049] Fig.10 is a schematic diagram of the structure of an artificial heart valve according to an embodiment of the present disclosure, viewed from the bottom, from the proximal end to the distal end, when the leaflet structure is in an open state;

[0050] Fig.11 is a schematic structural diagram of an artificial heart valve without an anchoring unit according to another embodiment of the present disclosure;

[0051] Fig.12 It is a schematic structural diagram of a stent for an artificial heart valve without an anchoring unit according to an embodiment of the present disclosure. DETAILED DESCRIPTION

[0052] The present disclosure will be described in more detail below with reference to the accompanying drawings. In each of the accompanying drawings, the same / similar elements are represented by the same / similar reference numerals. For the sake of clarity, the various parts in the accompanying drawings are not drawn to scale. In addition, some well-known parts may not be shown in the drawings.

[0053] Several exemplary embodiments of artificial heart valves are disclosed herein and shown in the accompanying drawings. These embodiments should not be construed as limiting the invention in any way. On the contrary, the present disclosure is intended to include all novel and non-obvious features and aspects of the various disclosed embodiments, as well as various combinations and sub-combinations of each other.

[0054] Application Scenario

[0055] Figure 1 is a schematic diagram of a cross section of the heart showing the location of the native valves.

[0056] like Figure 1As shown, a healthy heart has four chambers, including the left atrium, right atrium, left ventricle and right ventricle. The left and right sides of the heart are separated by a wall commonly referred to as the septum. The natural valves of the heart include: the mitral valve P2 for connecting the left atrium and the left ventricle, the aortic valve P1 for connecting the left ventricle and the aorta, the tricuspid valve P3 for connecting the right atrium and the right ventricle, and the pulmonary valve P4 for connecting the right ventricle and the pulmonary artery.

[0057] If the natural valve becomes diseased, an artificial heart valve can be implanted into the diseased site through surgery or transcatheter implantation, thereby replacing the natural valve with an artificial heart valve.

[0058] After a traditional artificial heart valve is implanted to replace the corresponding natural valve, as the patient grows, if the implanted artificial heart valve is no longer suitable in size and cannot expand (for example, the currently commercially available pulmonary artificial heart valve is a non-expandable valve catheter), the patient needs to undergo invasive replacement surgery every few years, which brings great pain to the patient and also adds pressure on medical expenses.

[0059] Specifically, in order to replace the pulmonary valve P4, traditional artificial heart valves are mainly developed for adults with stable heart size, and after these traditional artificial heart valves are implanted to replace the pulmonary valve P4, pulmonary artery regurgitation caused by Tetralogy of Fallot (TOF) repair surgery has become a common postoperative sequelae.

[0060] According to various embodiments of the present disclosure, an artificial heart valve is provided, wherein the artificial heart valve or at least a portion thereof has a mesh structure that allows the artificial heart valve to contract or expand in a radial direction, so that after being anchored / implanted in the heart, the artificial heart valve can expand to have an expanded radial size, thereby allowing the artificial heart valve to operate in different states without being replaced / removed.

[0061] In some applications where an artificial heart valve is used to replace the pulmonary valve, compared to the prior art, the artificial heart valve according to the embodiments of the present disclosure can treat pulmonary valve stenosis through a single implantation and prevent regurgitation after implantation without the need for another operation to replace or remove the implanted artificial heart valve.

[0062] Basic structure

[0063] Figure 2 is a schematic structural diagram of an artificial heart valve according to an embodiment of the present disclosure. Fig. 9 According to an embodiment of the present disclosure (for example, Figure 2 and 11Schematic diagram of the structure of an artificial heart valve (as shown) viewed from the distal end to the proximal end when the leaflet structure is in an open state. Fig.10 According to an embodiment of the present disclosure (for example Figure 2 and 11 Schematic diagram of the structure of an artificial heart valve (as shown) viewed from the proximal end to the distal end when the leaflet structure is in an open state.

[0064] like Figure 2 As shown, an artificial heart valve 1000 for replacing a natural heart valve mainly includes an annular stent 100 and a leaflet structure 200 attached to the stent 100 .

[0065] The stent 100 is used to anchor the artificial heart valve 1000 at a target implantation site (eg, aortic valve site, pulmonary valve site, mitral valve site, tricuspid valve site). The stent 100 may be annular and may have a distal end 1 and a proximal end 2 opposite to each other in the axial direction.

[0066] In order to make the artificial heart valve 1000 adaptable in size, the stent 100 adopts a mesh design, and its material is, for example, cobalt-nickel alloy or annealed nickel-titanium alloy. As an example, the stent 100 includes at least a mesh structure that allows the stent 100 to contract or expand in the radial direction. Therefore, as the heart grows, the stent 100 can be further expanded after the artificial heart valve 1000 is anchored in the heart to have an expanded radial size, thereby allowing the artificial heart valve to work in different states without being replaced. In some embodiments, the diameter of the stent 100 can range from 2 mm to 55 mm, preferably from 10 mm to 30 mm.

[0067] For example, different states of the artificial heart valve 1000 may include one or more of the following states: a first state, having a first radial dimension that replaces the natural valve during the implantation stage; a second state, having a second radial dimension that is adjusted by expansion according to the growth of the heart after the implantation stage; a third state, having a third radial dimension and serving as a docking adapter for a valve-valve procedure, wherein the second radial dimension is larger than the first radial dimension and smaller than the third radial dimension.

[0068] In the first state, the artificial heart valve 1000 is implanted, for example, by surgical implantation or intervention (transcatheter), to replace the diseased natural valve of a patient (e.g., a child aged 18 months and above). Because the stent 100 has a mesh structure as an annular side wall, the artificial heart valve 1000 can be compressed into a delivery device in a transcatheter application.

[0069] After the implantation is completed, as the child grows, the heart may require a larger valve to maintain its function, and the implanted artificial heart valve 1000 can be expanded (for example, by balloon expansion) to allow the artificial heart valve 1000 to operate in a second state without having to replace the implanted artificial heart valve 1000 with another valve by implantation again.

[0070] In addition, as the child grows, if the implantation location of the heart grows beyond a certain size and the function of the artificial heart valve 1000 as a valve cannot be supported, the implanted artificial heart valve 1000 can be further expanded from the second state to a third state and serve as a docking adapter in the third state for connection to another valve structure in a future valve-in-valve surgery without being replaced or removed.

[0071] Based on the artificial heart valve 1000 according to the embodiment of the present disclosure, various tests have been performed, including stent expansion test, valve expansion test, valve pulsation flow test, valve fatigue test, etc. Based on these feasibility tests, several size levels can be set for different states of the artificial heart valve 1000.

[0072] As a first example, the first radial dimension of the first state may be size 12 (which may indicate that the outer diameter of the stent is 12 mm), which allows the artificial heart valve 1000 to provide sufficiently good hemodynamics; the second radial dimension of the second state may be expanded from size 12 to size 15 (which may indicate that the outer diameter of the stent is 15 mm), which may also provide sufficiently good hemodynamics; and the third radial dimension of the third state may be expanded to size 16 (which may indicate that the outer diameter of the stent is 16 mm) and above or size 22 (which may indicate that the outer diameter of the stent is 22 mm) and above, providing support for using the artificial heart valve 1000 as a docking adapter / station for valve-in-valve surgery. For example, when the artificial heart valve 1000 is used as a docking adapter, a pulmonary valve for replacement may be delivered to the heart through a catheter, and the balloon on the tip of the catheter may be expanded to press the new pulmonary valve into the artificial heart valve 1000 already existing in the heart that is used as a docking adapter.

[0073] As a second example, the first radial dimension of the first state can be size 14 (which can indicate that the outer diameter of the stent is 14 mm), which allows the artificial heart valve 1000 to provide sufficiently good hemodynamics; the second radial dimension of the second state can be expanded from size 14 to approximately size 18 (which can indicate that the outer diameter of the stent is 18 mm), which can also provide sufficiently good hemodynamics; and the third radial dimension of the third state can be expanded to size 19 (which can indicate that the outer diameter of the stent is 19 mm) and above or size 22 (which can indicate that the outer diameter of the stent is 22 mm) and above, providing support for the artificial heart valve 1000 as a docking adapter / station for valve-in-valve surgery.

[0074] As a third example, the first radial dimension of the first state can be size 16, which can allow the artificial heart valve 1000 to provide sufficiently good hemodynamics; the second radial dimension of the second state can be expanded from size 16 to approximately size 18, which can also provide sufficiently good hemodynamics; and the third radial dimension of the third state can be expanded to size 19 and above or size 22 and above to provide support for using the artificial heart valve 1000 as a docking adapter / station for valve-in-valve surgery.

[0075] It should be noted that if the implantation site of the patient's (child or adult) heart has grown to a size matching the second state of the artificial heart valve 1000 before implantation, the artificial heart valve 1000 can be directly expanded to the second state during the implantation stage. The expansion range of the artificial heart valve 1000 is designed to provide adequate hemodynamics.

[0076] In some embodiments, the artificial heart valve 1000 is used to replace the natural pulmonary valve. In the prior art, stenosis and regurgitation may occur after the valve is implanted, requiring the use of other devices for remediation. According to the prior art, for example, valve conduit replacement can be used to repair stenosis and regurgitation, or a patch can be used to solve the stenosis problem. However, the size of the valve conduit cannot be expanded as the implantation site grows, and the patch may further cause regurgitation. Compared to the prior art, the artificial heart valve 1000 according to the embodiment of the present disclosure can treat pulmonary valve stenosis through a single implantation and prevent regurgitation after implantation without the need to replace or remove the implanted artificial heart valve again through surgery.

[0077] However, the present disclosure is not limited thereto, and in other embodiments, the artificial heart valve 1000 may also be used to replace natural valve structures such as a natural tricuspid valve.

[0078] In some optional embodiments, the material of the stent 100 may be medical stainless steel, nickel-titanium alloy (Nitinol) or cobalt-chromium alloy, etc.

[0079] In some optional embodiments, the wall thickness along the radial direction of the stent 100 may be 0.1 mm to 1 mm, for example, 0.2 mm to 0.6 mm.

[0080] like Figure 2 As shown, the leaflet structure 200 includes a plurality of leaflets 210, each leaflet 210 is connected to the stent and has a first portion 211 disposed in the stent 100 and a second portion 212 rolled to the peripheral side of the proximal end of the stent 100. The leaflet structure 200 allows blood to flow through the artificial heart valve 1000 in one direction from the proximal end 2 to the distal end 1, and inhibits blood from flowing through the artificial heart valve 1000 in the direction from the distal end 1 to the proximal end 2. As an example, Figure 2 As shown, the leaflet structure 200 can be formed by three interconnected leaflets 210, and each leaflet 210 is attached to a corresponding position of the stent 100.

[0081] In some optional embodiments, the material of each leaflet 210 may be bovine pericardium, porcine pericardium or a polymer material. In some optional embodiments, the wall thickness of each leaflet may be 0.1 mm to 0.7 mm, for example, 0.2 mm to 0.45 mm.

[0082] In some optional embodiments, such as Figure 2 As shown, the stent 100 of the artificial heart valve 1000 may also include one or more anchoring units 120, each of which is arranged at the distal end of the mesh structure 110 and is used to anchor to the corresponding anchoring position of the heart (e.g., the pulmonary valve position). As an example, a plurality of anchoring units may be arranged at intervals at the distal end of the mesh structure 110. As an example, each anchoring unit 120 may be provided with a connecting cavity 30 (e.g., a hole, a slit or a groove) at the distal end 1. As an example, each anchoring unit 120 may have an annular structure that extends along the axial direction of the stent 100 and allows a suture or line to pass through for anchoring. However, each connecting cavity of the anchoring unit is not limited to the shape shown in the figure, and may also be designed to be circular, square, elliptical, polygonal, irregular, etc. It should be understood that in some applications, according to actual needs and design, the stent 100 of the artificial heart valve 1000 may be implemented without the anchoring unit 120.

[0083] In some optional embodiments, the mesh structure 110 itself can be used to anchor to the corresponding anchoring position of the heart, so in addition to Fig.11 The mesh structure 110 shown in the figure does not require any further anchoring units to be provided in the artificial heart valve 1000, so that the structure of the stent 100 (eg Fig.12 As an example, the mesh cells of the mesh structure 110 may allow sutures or threads to pass through for anchoring.

[0084] Figure 3 According to an embodiment of the present disclosure (for example Figure 2 Schematic diagram of the structure of the stent of the artificial heart valve). Fig.11 A schematic structural diagram of an artificial heart valve without an anchoring unit according to another embodiment of the present disclosure is shown. Fig.12 According to an embodiment of the present disclosure (for example Fig.11 Schematic diagram of the structure of the stent of the artificial heart valve).

[0085] like Figure 3 and Fig.12 As shown, the stent 100 includes a mesh structure 110, which includes a plurality of first mesh units 110a and a plurality of second mesh units 110b distributed in the circumferential direction. The plurality of second mesh units 110b correspond in position to the joints 20 formed by adjacent leaflets 210, respectively, so that the joints 20 can be fixed to the stent 100 based on the second mesh units 110b. The number of the second mesh units 110b can be greater than / equal to the number of the leaflets 210.

[0086] In some embodiments, the stent 100 may further include a plurality of struts 130, so that the leaflets 210 may be attached to the struts 130, and each strut extends a certain length from the proximal end to the distal end of the mesh structure 110 to the proximal end 2 of the stent 100. The proximal ends of the plurality of struts 130 may be connected to provide structural support for the second portion 212 of each leaflet 210, and the second portion 212 of each leaflet 210 is rolled to the peripheral side of the proximal end of the stent 100.

[0087] As an example, the width of each strut 130 may be 0.1 mm to 1 mm, such as 0.2 mm to 0.7 mm.

[0088] As an example, at least one strut 130 can be used as a free cantilever, which does not affect the contraction and expansion of the stent 100, thereby allowing further expansion of the artificial heart valve 1000. As a cantilever, each strut 130 has a fixed end that is constantly attached to the mesh structure 110 and a free end that extends to the proximal end 2. Therefore, in a variant embodiment, each strut 130 can have at least three degrees of freedom of motion, including two degrees of freedom of translational motion and one degree of freedom of rotational motion. The two translational motions are selected from two of the three translational motions along the X, Y and Z axis directions (for example, corresponding to the X and Y axis directions). The X, Y and Z directions are defined in a coordinate system with the connection point between the fixed end of the mesh structure 110 and the strut 130 as the origin. The rotational motion can be selected from two rotational motions (rotation and revolution). Rotation refers to rotation around its own axis to allow the free end of the strut 130 to rotate around itself. Revolution refers to the rotation of the free end of the strut 130 around an axis other than its own, such as the axis of the cylindrical shape formed by the circumferential side wall of the mesh structure, or the axis or pseudo-axis formed when the free end of the strut 130 is lifted and rotated around it. In another variant embodiment, each strut 130 can further translate in another direction, for example, along the Z axis. In yet another variant embodiment, each strut 130 can also rotate along another axis. The movement of the struts in three or four degrees of freedom allows further expansion in different states of the valve 1000, and can have minimal impact on the structure of the artificial heart valve 1000. For example, at least one of the struts 130 can be slightly deformed (for example, based on bending, twisting and / or tilting of the fixed end as a fulcrum), so that the free end of each strut 130 can deviate from its initial position to a subsequent position.

[0089] As an example, the mesh structure 110 and the plurality of struts 130 may be integrally formed of the same material, which may have sufficient toughness to allow the mesh structure 110 to contract and expand, and allow the free end of each strut 130 to have at least three degrees of freedom, including translational freedom along the X, Y, and Z axes.

[0090] As an example, at least one of the struts 130 is provided with a cavity 10. For example, Figures 2 to 3 As shown, the cavity 10 may be a hole disposed at the proximal end 2 of the stent 100, and each strut 130 may still move in at least three degrees of freedom relative to the direction of blood flow pressure. At the same time, the covering according to the embodiment of the present disclosure may also have sufficient flexibility to support movement.

[0091] In some optional embodiments, the plurality of first grid units 110a are evenly divided into a plurality of first grid unit groups, each first grid unit group is composed of one or more first grid units 110a connected one by one in a circumferential direction, and every two adjacent first grid unit 110a groups are connected by a corresponding second grid unit 110b.

[0092] In some embodiments provided with struts 130, both ends of the second portion 212 in each leaflet 210 may be respectively attached to two adjacent second grid units 110b and at least one strut 130. Each strut 130 may be connected to the corresponding first grid unit 110a at the proximal end 2, and, for each first grid unit group, the lengths of the corresponding plurality of struts 130 may gradually decrease from the middle to both sides.

[0093] In some optional embodiments, such as Figure 3 and Fig.12 As shown, each first grid unit 110a may have a ring / fusiform / diamond-shaped frame. As an example, in order to facilitate contraction and expansion, each first grid unit 110a may be configured as a fusiform frame, with opposite ends thereof pointing to the proximal end and the distal end, respectively.

[0094] In some optional embodiments, the sizes / shapes of the plurality of first grid units 110a may all be the same or similar, and the sizes / shapes of the second grid units 110b may all be the same or similar. However, the embodiments of the present disclosure are not limited thereto, and in other embodiments, the grid units of the mesh structure may have different shapes.

[0095] In some optional embodiments, every two adjacent grid units (one of which is the first grid unit 110a or the second grid unit 110b) share a common frame edge extending from the distal end 1 to the proximal end 2. For example, Figure 3 and Fig.12 As shown in FIG. 1 , two adjacent first grid units 110 a may share a common frame edge, and each second grid unit 110 b and the adjacent first grid unit 110 a may share a common frame edge (having a corresponding first point A or a corresponding second point A′).

[0096] In some embodiments, every two adjacent second grid units 110b may be separated by at least one first grid unit 110a. Figure 3 and 12 As shown, the number of first grid units 110a arranged between every two adjacent second grid units 110b can be the same. As a further example, the number of first grid units 110a arranged between every two adjacent second grid units 110b can be an odd number, and / or, the length of the struts 130 of the first grid units 110a located between two adjacent second grid units 110b can be reduced from the middle to both sides along the circumferential direction of the stent 100, so that the position of the free end of each strut 130 can be adapted to the position of the second portion 212 of the corresponding leaflet 210 at the proximal end 2, which is conducive to the struts 130 providing support for the leaflet 210.

[0097] In some optional embodiments, such as Figure 3 and Fig.12 As shown, each of the plurality of first grid units 110 a and the plurality of second grid units 110 b has a distal frame edge having a first arch angle 31 directed toward the distal end 1 .

[0098] In some embodiments with anchoring unit 120, such as Figure 3 As shown, each anchoring unit 120 may be connected to a corresponding first arch 31 .

[0099] In some optional embodiments, such as Figure 3 and Fig.12 As shown in FIG. 2 , each first grid unit 110 a has a proximal frame edge having a second arch corner 32 directed toward the proximal end 2 , and each strut 130 can be connected to a corresponding second arch corner 32 .

[0100] In some optional embodiments, such as Figure 3 and Fig.12 As shown, each second grid unit 110 b provides a concave frame edge 111 at the proximal end 2 to allow the second portion 212 of the corresponding leaflet 210 to be rolled from the concave frame edge 111 to the outer peripheral side of the stent 100 .

[0101] In some optional embodiments, such as Figure 3 and Fig.12 As shown, the concave frame edge 111 includes: a first connection point A at the proximal end 2, connected to an adjacent first grid unit; a second connection point A' at the proximal end 2, connected to another adjacent first grid unit 110a; a first frame edge 11 and a second frame edge 12 extend from the first connection point A and the second connection point A', respectively, and form a corner 13 pointing to the distal end 1. As an example, the corner 13 can be an arc, a sharp angle or other shapes, including shapes not specifically described in the present disclosure.

[0102] The second portions 212 of the two adjacent leaflets 210 are respectively rolled over from the first frame edge 11 and the second frame edge 12 to the outer peripheral side of the proximal end of the stent 100 .

[0103] It should be noted that the cavity 10 mentioned in the present disclosure is not limited to Figure 3 The circular hole shown can also be designed into a rectangle, an ellipse, a polygon, an irregular shape or other shapes. In some optional embodiments, the cavity 10 can also be implemented as slits and grooves of various shapes. In some preferred embodiments, the slit is easy to be inserted or passed through.

[0104] In addition, as an optional embodiment, the covering layer can be a single-piece structure or a multi-piece structure, the covering layers of the multi-piece structure can be connected or spliced ​​to each other, and the covering layers of the single-piece or multi-piece structure can be attached to the inner surface and / or outer surface of the bracket.

[0105] Figure 4 A schematic structural diagram of the leaflet according to an embodiment of the present disclosure is shown. Figure 5 A flattened schematic diagram of the structure of a single leaflet according to an embodiment of the present disclosure is shown.

[0106] like Figure 2 , 4 As shown in FIGS. 5 and 5 , the leaflet structure 200 includes a plurality of leaflets 210 for allowing blood to flow through the artificial heart valve 1000 in a direction from the proximal end 2 to the distal end 1 and inhibiting blood from flowing through the artificial heart valve 1000 in a direction from the distal end to the proximal end 2 .

[0107] As a typical example, Figure 2 and Figure 4 As shown, the leaflet structure 200 includes three leaflets 210 arranged at an angle and interconnected, and the present disclosure is mainly explained based on this example. However, the present invention does not limit the number of leaflets 210 in the leaflet structure 200, and the leaflet structure 200 can also be composed of two or more leaflets 210.

[0108] like Figure 5 As shown, the flattened shape of a single leaflet 210 is, for example, semicircular or quasi-semicircular, having an arcuate edge 22 corresponding to the second part 212 and a free edge 21 corresponding to the first part 211, the free edge being located at the distal end 1 and extending between the two ends of the arcuate edge 22, the arcuate edge 22 being rolled over to the peripheral side of the proximal end of the stent 100 and attached to the corresponding second grid unit 110b, the corresponding first grid unit 110a, and at least one of the struts 130.

[0109] The first part 211 of the multiple leaflets 210 is arranged within the stent 100. In the closed state, the free edges 21 of the multiple leaflets 210 contact each other to inhibit blood from flowing through the artificial heart valve 1000 from the distal end 1 to the proximal end 2; in the open state, the free edges 21 of the multiple leaflets 210 are at least partially separated from each other to allow blood to flow through the artificial heart valve 1000 from the proximal end 2 to the distal end 1.

[0110] In some embodiments, the stent 100 may have a proximal profile that matches the arcuate edges 22 of the plurality of leaflets 210 .

[0111] In some embodiments, each end of each free edge 21 can be fixed to the free edge 21 of another adjacent leaflet 210 to form a joint 20, so that the adjacent leaflets 210 can be connected to each other at the joint 20, such as Figure 2 The commissures 20 formed by the plurality of leaflets 210 are attached to the stent 100 , for example, each commissure 20 formed by the plurality of leaflets 210 may be attached to each second mesh unit 110 b , respectively.

[0112] As an example, Figure 2 and 4 As shown, the second portion 212 of each leaflet 210 can be folded from the internal space surrounded by the stent 100 to the outside of the stent 100 based on one or more struts 130, so that the second portion 212 of the leaflet can be attached to the outer side of the stent 100.

[0113] In some embodiments, the plurality of struts 130 may be completely / partially covered by the second portions 212 of the plurality of leaflets 210 , and the second portions 212 of the plurality of leaflets 210 extend to a certain height on the outer side of the stent in the axial direction.

[0114] Based on Figure 4 In the exemplary stent structure shown, for each leaflet 210, the first frame line 11 and the second frame line 12 included in the concave frame edge 111 can form a corner 13, which serves as a joining structure pointing toward the distal end 1 to allow the second portion 212 of the leaflet 210 to be folded from the inside to the outside of the stent 100 at the proximal end 2 of the stent 100 based on the arc contour formed by the first frame line 11 and the second frame line 12 of the second grid unit 110b according to the strut 130, and at the same time allow the first portion 211 of the leaflet 210 to be attached to the opposite side (i.e., the inside) of the stent 100.

[0115] In order to stably fix the leaflet structure 200 to the stent 100 and avoid direct contact between the stent (for example, made of metal) and tissue (which may cause calcification, stress concentration and affect durability), one or more covering layers may be circumferentially arranged on the outer side of the stent 100 to serve as a connecting structure with the leaflet 210.

[0116] Figure 6 A schematic diagram showing the positional relationship between the covering layer and the bracket according to an embodiment of the present disclosure is shown. Figure 7a The artificial heart valve is shown in Figure 6 A schematic diagram of the cross-sectional structure of a support rod along the radial direction of the support is shown. Figure 7b The artificial heart valve is in the expanded state at a branch position along the Figure 6 A schematic diagram of the cross-sectional structure of the bracket in the radial direction is shown. Figure 8 Shown as Figure 6 , 7a and 7b are schematic diagrams of the structure of the covering layer shown.

[0117] In some optional embodiments, in order to fix the leaflet 210 to the stent 100, a cover layer 300 is provided as a basis for suturing. Figure 6 and Figure 8 As shown, the covering layer 300 may be in the shape of a skirt and attached to the outer peripheral side of the stent 100 and connected to the second portion 212 of each leaflet 210 .

[0118] In some embodiments, the plurality of first grid units 110 a and the plurality of second grid units 110 b may be fully / partially covered by the cover layer 300 .

[0119] In some embodiments, the plurality of struts 130 may be fully / partially covered by the cover layer 300 .

[0120] As an example, the covering layer 300 may have a distal profile that matches the distal profile of the mesh structure 110 of the stent 100 (including the distal arch of the first grid unit and the distal arch of the second grid unit), and have a proximal profile that matches the proximal profile of the stent 100, that is, the covering layer 300 may extend in an axial direction from the distal edge of the mesh structure 110 to the proximal end of the strut 130 and the concave frame edge 111 of the second grid unit 110b to completely cover the mesh structure 110 and the strut 130.

[0121] In some optional embodiments, such as Figure 6 , 7a As shown in 7b, at least the proximal portion of the covering layer 300 is clamped between multiple leaflets 210 and multiple struts 130, so that the second portion 212 of the leaflet and the covering layer 300 can be connected together through the struts by using blanket sutures, locking sutures and / or other types of sutures to connect to the stent 100.

[0122] In some embodiments, the covering layer 300 may be sutured to the stent 100 along a distal contour of the mesh structure 110 of the stent 100 (including a distal arch of a first mesh unit and a distal arch of a second mesh unit) and / or a proximal contour of the stent 100 .

[0123] As an example, the covering layer 300 is sutured to the stent 100 along the distal frame edge (e.g., each distal arch) of each mesh unit (110a, 110b) in the mesh structure 110 and / or the proximal frame edge (e.g., each proximal arch) of each mesh unit in the mesh structure 110, so that when the artificial heart valve 1000 is expanded to another state with a larger radial dimension (such as the second state / third state mentioned above) after implantation, the sutures arranged using this suturing method during the implantation stage will not be affected or pulled.

[0124] Additionally, as an example, the cover layer 300 and the second portion 212 of each leaflet 210 may also be sewn along one or more struts 130 .

[0125] In some simplified embodiments, cover layer 300 may be the only cover layer attached to stent 100 .

[0126] According to the embodiment of the present disclosure, reference Figure 2 , 4 and 6. Compared with the stent 100 in the first state and / or the second state, the size of the leaflet 210 exceeds the stent adaptation size in that state, so that the leaflet structure 200 can expand together with the stent 100 after implantation without losing its functionality and without being damaged during the expansion process.

[0127] In some embodiments, Figure 7a and 7b As shown, the edge end of the second part of each leaflet 210 is connected to the stent 100 at a position between the distal end 1 and the proximal end 2 of the stent 100 without being fixed at the proximal end of the stent, and the size of each leaflet 210 in at least one state exceeds the adaptation size of the stent in that state, so that in at least one state (the first state and / or the second state), at least one leaflet 210 can freely droop / fall in the direction from the distal end to the proximal end to a position away from the stent 100, so as to allow the leaflet 210 to expand together with the stent 100 without restraint at the proximal end of the stent 100, that is, to allow the stent 100 to expand further to form a more functional valve. Thus, the freedom at the bottom provides space to accommodate redundant leaflet material and allows the redundant leaflet material to sag to form a more functional valve at a location away from the stent 100 (in an expandable artificial heart valve, the redundant leaflets may be located at the bottom of the stent, allowing greater freedom at the bottom. This arrangement reduces the chance of twisting or blockage of the leaflets at the distal end, thereby improving the performance of the valve in the open state and providing a more functional valve).

[0128] In some embodiments, the oversized leaflet 210 that is circumferentially rolled at the strut 130 of the proximal end 2 may be pleated / folded in multiple places and sutured along the strut 130 and / or the cover 300 to allow for future expansion. For example, the second portion 212 of at least one leaflet 210 may be pleated / folded in multiple places at the peripheral side of the proximal end of the stent 100 to form folds extending along the strut 130, so as to be able to expand with the stent 100 in the above-mentioned different states. In addition, the multi-folded / pleated portion of the leaflet 210 at the proximal end may also be used as a cushion to prevent leakage / regurgitation.

[0129] According to the embodiments of the present disclosure, Figure 8As shown, the covering layer 300 may be provided with a plurality of openings 310 so that the covering layer 300 can expand together with the stent 100 after implantation without losing its function and avoiding damage during expansion in different states.

[0130] The plurality of openings 310 may be slits, holes, etc., and may all be designed in the same shape or in various shapes.

[0131] As an example, one or more openings 310 can be triangular holes, for example, with at least one angle pointing to the distal end / proximal end. However, the shapes disclosed herein are not intended to limit the present invention, and one or more openings can also be designed as other types of shapes, such as circular / elliptical holes, rectangular holes / slits, etc.

[0132] As an example, the plurality of openings 310 may be arranged in columns, with each column of openings extending from the distal end 1 to the proximal end 2 .

[0133] In some embodiments, each first grid unit 110 a may correspond in position to a corresponding at least one opening 310 .

[0134] In some optional embodiments, the cover layer 300 can be manufactured as a one-piece cover layer to maintain its ability to further expand. The material of the cover layer 300 can be PET or other materials that promote endothelialization. In some optional embodiments, the thickness of the cover layer 300 can be 0.05mm to 0.5mm, for example 0.1mm to 0.25mm.

[0135] According to the embodiments of the present disclosure, there is also provided an assembly method of an artificial heart valve applicable to any embodiment of the present disclosure. The specific steps can be performed according to the description of the above-mentioned embodiments of the artificial heart valve, which will not be repeated here.

[0136] The artificial heart valve provided according to the embodiment of the present disclosure is used to replace the natural valve of the heart, and the artificial heart valve mainly includes: a stent and a leaflet structure, and the stent has a mesh structure as a circumferential side wall, so that the stent is expandable at least in the radial direction. As the heart grows, after the artificial heart valve is anchored to the heart, the stent can expand to have an expanded radial dimension, thereby allowing the artificial heart valve to work in different states without being replaced / removed. Based on this, after the artificial heart valve is implanted in the heart by surgery or transcatheter delivery, the artificial heart valve according to the embodiment of the present disclosure can maintain functionality (as a valve or as a docking adapter) during the growth of the patient (for example, from 18 months to 16+ years old or even to 18+ years old). Therefore, the patient does not need to frequently replace the implanted artificial heart valve by surgery or transcatheter delivery, saving medical expenses and reducing pain.

[0137] In some applications, the artificial heart valve according to the embodiments of the present disclosure is used to replace the native pulmonary valve, can be implanted to treat pulmonary valve stenosis, and can prevent regurgitation after implantation if it is not replaced.

[0138] In some optional embodiments, the second portion of at least one leaflet has multiple folds / pleats on the peripheral side of the proximal end of the stent to form folds extending along the struts, so that it can expand with the stent. The multiple folds / pleats of the leaflet at the proximal end can be used as a cushion to prevent leakage / regurgitation.

[0139] In some optional embodiments, the artificial heart valve also includes a covering layer, which is attached to the peripheral side of the stent and connected to the second part of each leaflet to avoid calcification, stress concentration and durability caused by direct contact between the stent and the tissue. In some embodiments, the covering layer can be designed to have openings (e.g., slits, holes) to support further expansion of the stent. In some embodiments, the covering layer can be sutured to the stent along each distal frame edge of the mesh structure and / or each proximal frame edge of the mesh structure, thereby allowing the suture line on the opposite side to be not affected or pulled when the artificial heart valve is expanded.

[0140] In some optional embodiments, the different states of the artificial heart valve include one or more of the following states: a first state (for example, for children 18 months and older), having a first radial dimension for replacing a natural valve during the implantation stage; a second state, having a second radial dimension that is adjusted by expansion according to the growth of the heart after implantation; a third state, having a third radial dimension and serving as a docking adapter for a valve-in-valve surgery, wherein the second radial dimension is larger than the first radial dimension and smaller than the third radial dimension.

[0141] In view of the fact that the principles of the present invention can be applied to many possible embodiments, it should be recognized that the embodiments presented herein are only preferred examples of the present invention and should not be considered to limit the scope of the present invention. On the contrary, the scope of the present invention is defined by the appended claims. We claim all rights within the scope and spirit of these claims and their equivalents.

Claims

1. An artificial heart valve for replacing a natural heart valve, wherein: The artificial heart valve comprises: An annular stent (100) has a distal end (1) and a proximal end (2) in the axial direction, and comprises: a mesh structure (110) as a circumferential side wall of the stent, wherein the mesh structure allows the stent to contract or expand in a radial direction; and A leaflet structure (200) comprising a plurality of leaflets (210), each leaflet being attached to the stent and having a first portion (211) disposed within the stent and a second portion (212) rolled to the outer peripheral side of the proximal end of the stent, Wherein, as the heart grows, the stent can be expanded after the artificial heart valve is anchored in the heart to have an expanded radial size, thereby allowing the artificial heart valve to work in different states without being replaced. The edge end of the second portion of each leaflet is connected to the stent at a position between the distal end and the proximal end of the stent, but is not fixed to the proximal end of the stent, In at least one of the different states, the size of each leaflet exceeds the adaptation size of the stent in that state, and each leaflet has a redundant portion (210e) that freely hangs down in a direction from the distal end to the proximal end to a position away from the stent, so that the size of each leaflet allows the leaflet to move away from the stent to form a more functional valve.

2. The artificial heart valve according to claim 1, wherein: The artificial heart valve is used to replace the natural pulmonary valve.

3. The artificial heart valve according to claim 1, wherein: The stent further comprises a plurality of struts (130) for attaching the plurality of leaflets, and each strut extends distally from the proximal end of the mesh structure. Wherein, the second portion of each leaflet is rolled over at the proximal end of the plurality of struts to the outer peripheral side of the stent at the proximal end.

4. The artificial heart valve according to claim 3, wherein: Each of the leaflets is semicircular / quasi-semicircular in shape, having an arcuate edge corresponding to the second portion and a free edge corresponding to the first portion, the free edge being located at the distal end and extending between the two ends of the arcuate edge, The first parts of the plurality of leaflets are arranged in the stent, and the first parts of the plurality of leaflets are in contact with each other in a closed state to inhibit blood from flowing through the artificial heart valve in a direction from the distal end to the proximal end, or are separated from each other in an open state to allow blood to flow through the artificial heart valve in a direction from the proximal end to the distal end, The stent has a proximal profile that matches the arcuate edges of the plurality of leaflets.

5. The artificial heart valve according to claim 3, wherein: The mesh structure comprises a plurality of first mesh units (110a) and a plurality of second mesh units (110b) distributed along a circumferential direction, Adjacent leaflets in the plurality of valves are connected to each other to form a joint (20), which is attached to the corresponding second grid unit, and the two ends of the second part of each leaflet are respectively attached to two adjacent second grid units.

6. The artificial heart valve according to claim 5, wherein: The multiple first grid units are evenly divided into multiple first grid unit groups, each first grid unit group is composed of one or more first grid units continuously distributed along the circumferential direction, and every two adjacent first grid unit groups are connected through a corresponding one of the second grid units.

7. The artificial heart valve according to claim 6, wherein: The plurality of struts are respectively connected to the corresponding first grid units at the proximal ends, For each of the first grid unit groups, the length of the corresponding support rods gradually decreases from the middle to both sides.

8. The artificial heart valve according to claim 5, wherein: Each of the first grid cells has a shuttle / diamond-shaped frame; The plurality of first grid units have the same size; or Every two adjacent grid units share a common frame edge extending from the distal end to the proximal end, and one of the every two adjacent grid units is the first grid unit or the second grid unit.

9. The artificial heart valve according to claim 5, wherein: The stent further comprises a plurality of anchoring units (120), wherein the plurality of anchoring units (120) are arranged at intervals at the distal end of the mesh structure, and each of the anchoring units is used to anchor to a corresponding anchoring position of the heart.

10. The artificial heart valve according to claim 9, wherein: Each of the plurality of first grid units and the plurality of second grid units has a distal frame edge, the distal frame edge has a first arch angle pointing distally, and each of the anchoring units is connected to a corresponding first arch angle; or Each of the first grid units has a proximal frame edge, the proximal frame edge has a second arch angle pointing proximally, and each of the struts is connected to a corresponding second arch angle.

11. The artificial heart valve according to claim 5, wherein: Each of the second grid units provides a concave frame edge at a proximal end to allow the second portion of the corresponding leaflet to be rolled over the concave frame edge to the peripheral side of the stent.

12. The artificial heart valve according to claim 11, wherein: The concave frame edge comprises: A first connection point (A) at the proximal end is connected to an adjacent first grid unit; A second connection point (A') at the proximal end is connected to another adjacent first grid unit; A first frame line (11) and a second frame line (12) extend from the first connection point and the second connection point respectively to form a corner pointing to the distal end, The second parts of the two adjacent leaflets are respectively rolled over to the outer peripheral side of the stent at the proximal end through the corresponding positions of the first frame line and the second frame line.

13. The artificial heart valve according to claim 5, wherein: Also included is a covering layer (300), which is attached to the surface of the stent and connected to the second portion of each of the leaflets.

14. The artificial heart valve according to claim 13, wherein: The plurality of first grid cells and the plurality of second grid cells are completely covered by the covering layer; and The plurality of struts are at least partially covered by the second portion of the plurality of leaflets and / or the covering layer.

15. The artificial heart valve according to claim 13, wherein: A proximal portion of the covering layer is sandwiched between the stent and the second portion of the plurality of leaflets.

16. The artificial heart valve according to claim 13, wherein: The covering layer is sutured to the stent along each distal frame edge of the mesh structure and / or each proximal frame edge of the mesh structure. The covering layer is a single-piece structure or a multi-piece structure.

17. The artificial heart valve according to claim 13, wherein: The covering layer has a plurality of openings (310) for allowing the covering layer to expand with the stent.

18. The artificial heart valve according to claim 17, wherein: Each of the openings is a slit or a hole; The plurality of openings are arranged in a plurality of rows, each row of the openings extending from the distal end to the proximal end; or Each of the first grid cells corresponds in position to at least one of the openings.

19. The artificial heart valve according to claim 13, wherein: The plurality of struts respectively have a cavity (10) arranged at the proximal end, and the cavities of the plurality of struts are connected by sutures or threads, thereby providing structural support for the plurality of leaflets.

20. The artificial heart valve according to claim 19, wherein: The covering layer is sutured and connected to the stent based on the lumens of the plurality of struts.

21. The artificial heart valve according to claim 3, wherein: The second portion of at least one of the leaflets is folded / pleated at multiple locations on the peripheral side of the proximal end of the stent to form folds, which serve as a cushion to prevent leakage / reflux, and each fold extends along the strut to expand with the stent.

22. The artificial heart valve according to claim 1, wherein: The different states of the artificial heart valve include one or more of the following states: a first state having a first radial dimension for replacing a native valve during an implantation stage; a second state having a second radial dimension adjusted by expansion according to heart growth after said implantation stage; The third state has a third radial dimension and is used as a docking adapter for valve-in-valve surgery. The second radial dimension is larger than the first radial dimension and smaller than the third radial dimension.

23. The artificial heart valve according to claim 1, wherein: The artificial heart valve is implanted into the heart through surgery or transcatheter intervention.

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