Expandable prosthetic heart valve

Abstract

This disclosure relates to an artificial heart valve for replacing a natural heart valve, comprising: an annular stent including: a mesh structure serving as a circumferential sidewall of the stent; and a leaflet structure, each leaflet being attached to the stent and having a first portion disposed within the stent and a second portion rolled up to the proximal peripheral side of the stent. As the heart grows, the stent can be expanded after the artificial heart valve is anchored to the heart, thereby allowing the artificial heart valve to function in different states without replacement. The edge end of the second portion of each leaflet is connected to the stent at a location between the distal and proximal ends of the stent, but not fixed to the proximal end of the stent. In at least one state, the size of each leaflet exceeds the fit size of the stent in that state, and each leaflet has a redundant portion that hangs freely from the distal to the proximal end to a location away from the stent, thereby allowing the leaflet to be sized away from the stent to form a more functional valve.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more specifically, to an expandable artificial heart valve that can operate in different states. Background Technology

[0002] Natural heart valves, such as the aortic, pulmonary, mitral, and tricuspid valves, are critical structures that ensure an adequate and positive flow of blood 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 and even death, and may eventually require replacement of natural heart valves with artificial heart valves through surgery or minimally invasive (transcatheter implantation).

[0003] According to current technology, after implanting a traditional artificial heart valve to replace the corresponding natural valve, as the patient ages, if the implanted artificial heart valve is no longer the right size and cannot be expanded (for example, the currently available pulmonary artery artificial heart valve is a non-expandable valve catheter), the patient will need to undergo invasive replacement surgery every few years. This causes great pain to the patient and increases the burden on medical expenses.

[0004] Therefore, it is desirable to provide an artificial heart valve that, after being anchored to the heart in the early stages, can expand to a certain extent to have an expanded size that matches the growth of the heart. Summary of the Invention

[0005] Therefore, the purpose of this disclosure is to provide an expandable artificial heart valve that, after being anchored to the heart, can expand to have an expanded radial dimension, thereby allowing the artificial heart valve to function in different states without needing to be replaced / removed as the patient grows. The artificial heart valve provided according to embodiments of this disclosure can be used to replace the natural heart valves of children (from approximately 18 months of age) and can expand as the patient (e.g., a child) grows, thus reducing the need for frequent surgical or transcatheter interventional replacement of the implanted artificial heart valve, thereby saving medical costs and reducing suffering.

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

[0007] An annular stent (100), having a distal end (1) and a proximal end (2) in the axial direction, includes: a mesh structure (110) serving as a circumferential sidewall of the stent, the mesh structure allowing the stent to contract or expand in the radial direction; and

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

[0009] As the heart grows, the stent can be expanded to have an expanded radial dimension after the artificial heart valve is anchored to the heart, thereby allowing the artificial heart valve to function in different states without replacement. The edge end of the second portion of each leaflet is connected to the stent at a position between the distal and proximal ends of the stent, but not fixed to the proximal end of the stent. In at least one of the different states, the size of each leaflet exceeds the fit size of the stent in that state, and each leaflet has a redundant portion (210e) that hangs freely from the distal to the proximal end to a position away from the stent, thereby allowing the size of each leaflet to be away from the stent to form a more functional valve.

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

[0011] In some alternative embodiments, the stent further includes a plurality of struts (130) for attaching the plurality of leaflets, each strut extending distally from the proximal end of the mesh structure, wherein a second portion of each of the leaflets 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 alternative embodiments, each of the leaflets is semi-circular / quasi-semi-circular 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 distally and extending between the two ends of the arcuate edge, the first portions of the plurality of leaflets being disposed within the stent, the first portions of the plurality of leaflets being in contact with each other in a closed state to inhibit blood flow through the artificial heart valve in a distal-to-proximal direction, or being separated from each other in an open state to allow blood flow through the artificial heart valve in a proximal-to-distal direction, the stent having a proximal profile matching the arcuate edge of the plurality of 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 circumferentially, adjacent leaflets of the plurality of valves being connected to each other to form a junction (20), the junction (20) being attached to a corresponding second mesh unit, and the two ends of a second portion of each leaflet being 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 alternative embodiments, the plurality of first grid cells are uniformly divided into a plurality of first grid cell groups, each first grid cell group consisting of one or more first grid cells continuously distributed along the circumferential direction, and every two adjacent first grid cell groups are connected by a corresponding second grid cell.

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

[0016] In some alternative embodiments, each of the first grid cells has a spindle-shaped / rhomboid frame; the plurality of first grid cells are of the same size; or every two adjacent grid cells share a common frame edge extending from the far end to the near end, one of the two adjacent grid cells being either the first grid cell or the second grid cell.

[0017] In some alternative embodiments, the stent further includes a plurality of anchoring units (120) spaced apart at the distal end of the mesh structure, each of the anchoring units being used to anchor to a corresponding anchoring position in the heart.

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

[0019] In some alternative embodiments, each of the second grid cells is provided with a concave frame edge at its proximal end to allow the second portion of the corresponding leaflet to fold over the concave frame edge to the outer periphery of the support.

[0020] In some alternative embodiments, the concave frame edge includes: a first connection point (A) at the proximal end, connected to an adjacent first grid cell; a second connection point (A') at the proximal end, connected to another adjacent first grid cell; 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 portions of two adjacent leaflets are respectively rolled over at corresponding positions of the first frame line and the second frame line to the outer periphery of the support at the proximal end.

[0021] In some alternative embodiments, the artificial heart valve further includes a covering layer (300) 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 and / or inner surfaces of the stent.

[0022] In some alternative embodiments, 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 lobes and / or the covering layer.

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

[0024] In some alternative embodiments, the cover layer is stitched to the scaffold along each distal frame edge of the mesh structure and / or each proximal frame edge of the mesh structure, and the cover layer is a monolithic or multi-piece structure. In some embodiments, multi-piece cover layers may be interconnected or spliced ​​together.

[0025] In some alternative embodiments, the cover layer has a plurality of openings (310) for allowing the cover layer to expand with the support.

[0026] In some alternative embodiments, each of the openings is a slit or a hole; the plurality of openings are arranged in multiple columns, each column of 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.

[0027] In some alternative embodiments, the plurality of struts each have a cavity (10) arranged at the proximal end, the cavities of the plurality of struts being connected by sutures or wires to provide structural support for the plurality of leaflets.

[0028] In some alternative embodiments, the cover layer is stitched to the support based on the cavity of the plurality of struts.

[0029] In some alternative embodiments, at least one of the second portions of the leaflet is folded / pleated in multiple places on the outer periphery of the proximal end of the support to form folds, which serve as padding to prevent leakage / backflow, and each fold extends along the strut to facilitate expansion with the support.

[0030] In some alternative 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 adjusted by expansion according to the growth of the heart after the implantation stage; and a third state having a third radial dimension and serving as a docking adapter for valve-in-valve surgery, wherein the second radial dimension is greater than the first radial dimension and less than the third radial dimension.

[0031] In some alternative embodiments, the artificial heart valve is implanted into the heart via surgical or transcatheter intervention.

[0032] The artificial heart valve provided according to embodiments of this disclosure is used to replace the natural valve of the heart. The artificial heart valve mainly comprises a stent and leaflet structures. The stent has a mesh structure serving as circumferential sidewalls, making the stent 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 function in different states without needing replacement / removal. Based on this, after the artificial heart valve is implanted into the heart via surgery or transcatheter delivery, the artificial heart valve according to embodiments of this disclosure can maintain its functionality (as a valve or as a docking adapter) as the patient (e.g., from 18 months to 16+ years or even up to 18+ years) grows. Therefore, patients do not need to frequently replace the implanted artificial heart valve via surgery or transcatheter delivery, saving medical costs and reducing suffering.

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

[0034] In some alternative embodiments, at least one leaflet has multiple folds / pleats on its outer periphery near the proximal end of the stent to form folds extending along the strut, thereby enabling it to expand together with the stent. The multiple folds / pleats near the proximal end of the leaflet can serve as padding to prevent leakage / reflux.

[0035] In some alternative embodiments, the artificial heart valve further includes a covering layer attached to the peripheral side of the stent and connected to a second portion of each leaflet to avoid problems such as calcification, stress concentration, and reduced durability caused by direct contact between the stent and tissue. In some embodiments, the covering layer may be designed with openings (e.g., slits, orifices) to support further expansion of the stent. In some embodiments, the covering layer may 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 sutures on opposite sides to be unaffected and unstretched during expansion of the artificial heart valve.

[0036] In some alternative embodiments, different states of the artificial heart valve include one or more of the following states: a first state (e.g., for children 18 months and older) having a first radial dimension for replacing a natural valve during the implantation phase; a second state having a second radial dimension adjusted by expansion according to the growth of the heart after implantation; and a third state having a third radial dimension and serving as a docking adapter for 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-mentioned objects, other objects, and advantages of the various embodiments of the present invention after reading the following detailed description of the embodiments illustrated in the accompanying drawings. Attached Figure Description

[0038] Referring to the accompanying drawings, the above and other objects, features, and advantages of this disclosure will become more apparent from the following description of embodiments thereof, wherein:

[0039] Figure 1 This is a schematic diagram showing a cross-section of the heart with the natural valves in place;

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

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

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

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

[0044] Figure 6 This is a schematic diagram showing the positional relationship between the cover layer and the support according to an embodiment of the present disclosure;

[0045] Figure 7aArtificial heart valves are used in... Figure 6 A schematic diagram of the cross-sectional structure of the support along the radial direction at the location of one of the support rods is shown.

[0046] Figure 7b It is an artificial heart valve in an expanded state, located at a strut position along... Figure 6 A schematic diagram of the radial cross-sectional structure of the bracket shown;

[0047] Figure 8 As shown Figure 6 , 7a The structural diagram of the covering layer shown in Figure 7b;

[0048] Figure 9 This is a top view of an artificial heart valve according to an embodiment of the present disclosure with the leaflet structure in the open state, from the distal end to the proximal end.

[0049] Figure 10 This is a bottom view of an artificial heart valve according to an embodiment of the present disclosure with the leaflet structure in the open state, from the proximal end to the distal end.

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

[0051] Figure 12 This is a schematic diagram of the structure of a stent for an artificial heart valve without an anchoring unit according to an embodiment of the present disclosure. Detailed Implementation

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

[0053] This document discloses several exemplary embodiments of artificial heart valves, illustrated in the accompanying drawings. These embodiments should not be construed as limiting the invention in any way. Rather, this disclosure is intended to include all of the 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 scenarios

[0055] Figure 1 This is a schematic diagram showing a cross-section of the heart with the natural valves in place.

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

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

[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 be expanded (for example, the currently available pulmonary artificial heart valve is a non-expandable valve catheter), the patient will need to undergo invasive replacement surgery every few years. This causes great suffering for the patient and adds to the burden of medical expenses.

[0059] Specifically, traditional artificial heart valves for replacing the pulmonary valve P4 were primarily developed for adults with stable heart size. Furthermore, pulmonary regurgitation following tetralogy of Fallot (TOF) repair surgery has become a common postoperative sequela after these traditional artificial heart valves are implanted to replace the pulmonary valve P4.

[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, such that after the artificial heart valve is anchored / implanted into the heart, it can expand to have an expanded radial dimension, thereby allowing the artificial heart valve to work in different states without being replaced / removed.

[0061] In some applications where artificial heart valves are used to replace pulmonary valves, compared with the prior art, the artificial heart valves according to the embodiments of this disclosure can treat pulmonary valve stenosis with a single implantation and prevent regurgitation after implantation without the need for a second surgery to replace or remove the implanted artificial heart valve.

[0062] Basic structure

[0063] Figure 2 This is a schematic diagram of the structure of an artificial heart valve according to an embodiment of the present disclosure. Figure 9 According to an embodiment of this disclosure (e.g., as shown in the example), Figure 2 and 11The diagram shows a top view of the artificial heart valve from distal to proximal end with the leaflet structure in the open state. Figure 10 According to an embodiment of this disclosure (e.g.) Figure 2 and 11 The diagram shows a top-down view of an artificial heart valve with its leaflet structure in the open position, viewed from proximal to distal.

[0064] like Figure 2 As shown, the artificial heart valve 1000 used to replace the natural heart valve mainly includes a ring 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 (e.g., 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] To enable the artificial heart valve 1000 to adapt to different sizes, the stent 100 employs a mesh design, made of materials such as a cobalt-nickel alloy or an annealed nickel-titanium alloy. As an example, the stent 100 includes at least a mesh structure that allows it to contract or expand in the radial direction. Therefore, as the heart grows, the stent 100 can be further expanded to have an expanded radial dimension after the artificial heart valve 1000 is anchored within the heart, allowing the artificial heart valve to function in different states without replacement. 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; and 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 greater than the first radial dimension and less than the third radial dimension.

[0068] In the first state, the artificial heart valve 1000 is implanted, for example, via surgical implantation or interventional (transcatheter) procedure, to replace the diseased natural valve in a patient (e.g., a child 18 months and older). Because the stent 100 has a mesh structure serving as annular sidewalls, the artificial heart valve 1000 can be compressed into the delivery device in transcatheter applications.

[0069] After implantation, as the child grows, the heart may require a larger valve to maintain its function. The implanted artificial heart valve 1000 can be expanded (e.g., by balloon dilation) to allow the artificial heart valve 1000 to work in a second state without having to replace the implanted artificial heart valve 1000 with another valve through implantation.

[0070] Furthermore, as the child grows, if the implanted heart valve grows to a size larger than a certain size, causing the artificial heart valve 1000 to be unable to function as a valve, the implanted artificial heart valve 1000 can be further expanded from the second state to the third state, and in the third state it can serve as a docking adapter to connect to another valve structure in a future valve-in-valve surgery without being replaced or removed.

[0071] Various tests have been conducted on the artificial heart valve 1000 according to embodiments of the present disclosure, including stent expansion tests, valve expansion tests, valve pulsation flow tests, and valve fatigue tests. 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 can be size 12 (which can represent an outer diameter of 12 mm for the stent), allowing the artificial heart valve 1000 to provide sufficiently good hemodynamics; the second radial dimension of the second state can be expanded from size 12 to size 15 (which can represent an outer diameter of 15 mm for the stent), which also provides sufficiently good hemodynamics; and the third radial dimension of the third state can be expanded to size 16 (which can represent an outer diameter of 16 mm for the stent) or larger, or size 22 (which can represent an outer diameter of 22 mm for the stent) or larger, to support the use of 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 can be delivered to the heart through a catheter, and a balloon at the tip of the catheter can be expanded to press the new pulmonary valve into the artificial heart valve 1000 already present in the heart as a docking adapter.

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

[0075] It should be noted that if the patient's (child or adult) heart has already grown to a size that matches 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 sufficient 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 valve implantation, requiring remedial measures. 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 address the stenosis. However, the size of the valve conduit cannot expand as the implantation site grows, and the patch may further cause regurgitation. In contrast to the prior art, the artificial heart valve 1000 according to embodiments of this disclosure can treat pulmonary valve stenosis with a single implantation and prevent regurgitation after implantation without requiring further surgical replacement or removal of the implanted artificial heart valve.

[0077] However, this disclosure is not limited thereto. In some other embodiments, the artificial heart valve 1000 can also be used to replace natural valve structures such as the natural tricuspid valve.

[0078] In some alternative embodiments, the stent 100 may be made of medical stainless steel, nickel-titanium alloy, or cobalt-chromium alloy, etc.

[0079] In some alternative embodiments, the wall thickness along the radial direction of the support 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 being connected to a stent and having a first portion 211 disposed within the stent 100 and a second portion 212 rolled over to the outer periphery of the proximal end of the stent 100. The leaflet structure 200 allows blood to flow unidirectionally through the artificial heart valve 1000 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, such as 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 support 100.

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

[0082] In some alternative embodiments, such as Figure 2 As shown, the stent 100 of the artificial heart valve 1000 may further include one or more anchoring units 120, each anchoring unit 120 being disposed at the distal end of the mesh structure 110 and used for anchoring to a corresponding anchoring location in the heart (e.g., the pulmonary valve location). As an example, multiple anchoring units may be spaced apart at the distal end of the mesh structure 110. As an example, each anchoring unit 120 may have a connecting cavity 30 (e.g., a hole, slit, or groove) at its distal end 1. As an example, each anchoring unit 120 may have an annular structure extending along the axial direction of the stent 100 and allowing sutures or threads 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 as circular, square, elliptical, polygonal, irregular, etc. It should be understood that in some applications, depending on actual needs and design, the stent 100 of the artificial heart valve 1000 may be implemented without the anchoring units 120.

[0083] In some alternative embodiments, the mesh structure 110 itself can be used to anchor to a corresponding anchoring location on the heart, therefore, in addition to... Figure 11 The mesh structure 110 shown eliminates the need for any further anchoring units in the artificial heart valve 1000, thus allowing for the structural integrity of the stent 100 (e.g., Figure 12 (As shown) can be simplified. As an example, the mesh cells of the mesh structure 110 may allow stitching or thread to pass through for anchoring.

[0084] Figure 3 According to an embodiment of this disclosure (e.g.) Figure 2 The diagram shows a structural schematic of an artificial heart valve stent. Figure 11 A schematic diagram of an artificial heart valve without an anchoring unit according to another embodiment of the present disclosure is shown. Figure 12 According to an embodiment of this disclosure (e.g.) Figure 11 The diagram shows a structural schematic of an artificial heart valve stent.

[0085] like Figure 3 and Figure 12 As shown, the support 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 are respectively positioned to correspond to the connecting portions 20 formed by adjacent leaflets 210, such that the connecting portions 20 can be fixed to the support 100 based on the second mesh units 110b. The number of second mesh units 110b can be greater than or equal to the number of leaflets 210.

[0086] In some embodiments, the stent 100 may further include a plurality of struts 130 such that leaflets 210 can 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, the second portion 212 of each leaflet 210 being rolled up to the outer periphery of the proximal end of the stent 100.

[0087] As an example, the width of each support rod 130 can be 0.1mm to 1mm, for example, 0.2mm to 0.7mm.

[0088] As an example, at least one strut 130 can be used as a free cantilever that 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 constantly attached to the mesh structure 110 and a free end extending to the proximal end 2. Therefore, in a variant embodiment, each strut 130 may have at least three degrees of freedom, including two translational degrees of freedom and one rotational degree of freedom. The two translational movements are selected from two of the three translational movements along the X, Y, and Z axes (e.g., corresponding to the X and Y axes). The X, Y, and Z directions are defined in a coordinate system with the connection point between the mesh structure 110 and the fixed end of the strut 130 as the origin. The rotational movement can be selected from two rotational movements (rotation and revolution). Rotation refers to rotation about its own axis to allow the free end of the strut 130 to rotate about itself. Revolution refers to the rotation of the free end of the strut 130 about an axis other than itself, such as the axis of the cylindrical shape formed by the circumferential sidewalls of the mesh structure, or the axis or pseudo-axis formed when the free end of the strut 130 is lifted and rotates about it. In another variant embodiment, each strut 130 may further translate in another direction, for example, along the Z-axis. In yet another variant embodiment, each strut 130 may also rotate along another axis. The movement of the struts in three or four degrees of freedom allows for 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 may be slightly deformed (e.g., based on bending, twisting, and / or tilting of the fixed end as a fulcrum) such that the free end of each strut 130 may deviate from its initial position to a subsequent position.

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

[0090] As an example, at least one of the support rods 130 is provided with a cavity 10. For example, as Figures 2 to 3 As shown, cavity 10 can be a hole located at the proximal end 2 of stent 100, and each strut 130 can still move relative to the blood flow pressure direction in at least three degrees of freedom. Meanwhile, the cover according to embodiments of this disclosure can also have sufficient flexibility to support movement.

[0091] In some alternative embodiments, a plurality of first grid cells 110a are uniformly divided into a plurality of first grid cell groups, each first grid cell group consisting of one or more first grid cells 110a connected sequentially in the circumferential direction, and every two adjacent first grid cell groups 110a are connected by a corresponding second grid cell 110b.

[0092] In some embodiments with support rods 130, the two ends of the second portion 212 in each leaflet 210 may be attached to two adjacent second grid cells 110b and at least one support rod 130, respectively. Each support rod 130 may be connected to a corresponding first grid cell 110a at its proximal end 2, and for each group of first grid cells, the length of the corresponding plurality of support rods 130 may gradually decrease from the middle to both sides.

[0093] In some alternative embodiments, such as Figure 3 and Figure 12 As shown, each first grid cell 110a may have an annular / shuttle / rhomboid frame. As an example, to facilitate contraction and expansion, each first grid cell 110a may be configured as a shuttle frame with its opposite ends pointing to the proximal and distal ends, respectively.

[0094] In some optional embodiments, the size / shape of the plurality of first grid cells 110a may be all the same or similar, and the size / shape of each second grid cell 110b may be all the same or similar. However, the embodiments disclosed herein are not limited thereto, and in other embodiments, the individual grid cells of the mesh structure may have different shapes.

[0095] In some alternative embodiments, every two adjacent grid cells (one of which is a first grid cell 110a or a second grid cell 110b) share a common frame edge extending from the far end 1 to the near end 2. For example, as Figure 3 and Figure 12 As shown, two adjacent first grid cells 110a can share a common frame edge, and each second grid cell 110b and its adjacent first grid cell 110a can share a common frame edge (with a corresponding first point A or a corresponding second point A').

[0096] In some implementations, every two adjacent second grid cells 110b may be separated by at least one first grid cell 110a. For example, Figure 3 and 12 As shown, the number of first grid cells 110a arranged between every two adjacent second grid cells 110b can be the same. As a further example, the number of first grid cells 110a arranged between every two adjacent second grid cells 110b can be odd, and / or, the length of the support rod 130 of the first grid cell 110a located between two adjacent second grid cells 110b can decrease sequentially from the middle to both sides along the circumferential direction of the support 100, so that the position of the free end of each support rod 130 can be adapted to the position of the second part 212 of the corresponding leaflet 210 at the proximal end 2, which is beneficial for the support rod 130 to provide support for the leaflet 210.

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

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

[0099] In some alternative embodiments, such as Figure 3 and Figure 12 As shown, each first grid cell 110a has a proximal frame edge with a second arch 32 pointing towards the proximal end 2, and each support 130 can be connected to the corresponding second arch 32.

[0100] In some alternative embodiments, such as Figure 3 and Figure 12 As shown, each second grid cell 110b provides a concave frame edge 111 at its proximal end 2 to allow the second portion 212 of the corresponding leaflet 210 to roll over from the concave frame edge 111 to the outer periphery of the support 100.

[0101] In some alternative embodiments, such as Figure 3 and Figure 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 cell; a second connection point A' at the proximal end 2, connected to another adjacent first grid cell 110a; the first frame edge 11 and the second frame edge 12 extend from the first connection point A and the second connection point A' respectively, forming a corner 13 pointing towards the distal end 1. As an example, the corner 13 may be arc-shaped, sharp, or other shapes, including shapes not specifically described in this disclosure.

[0102] The second part 212 of the two adjacent leaflets 210 are rolled up from the first frame edge 11 and the second frame edge 12 to the outer periphery of the proximal end of the support 100, respectively.

[0103] It should be noted that cavity 10 mentioned in this disclosure is not limited to... Figure 3 The circular hole shown can also be designed as rectangular, elliptical, polygonal, irregular, or other shapes. In some alternative embodiments, cavity 10 can also be implemented as slits and slots of various shapes. In some preferred embodiments, the slit is easy to insert or pass through.

[0104] In addition, as an optional embodiment, the cover layer can be a single-piece structure or a multi-piece structure. Multi-piece cover layers can be connected or spliced ​​together, and single-piece or multi-piece cover layers can be attached to the inner and / or outer surfaces of the support.

[0105] Figure 4 A schematic diagram of the structure 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 Figure 5, the leaflet structure 200 includes a plurality of leaflets 210 for allowing blood to flow through the artificial heart valve 1000 in the direction from the proximal end 2 to the distal end 1, and for inhibiting blood flow through the artificial heart valve 1000 in the direction from the distal end to the proximal end 2.

[0107] As a typical example, such as Figure 2 and Figure 4 As shown, the leaflet structure 200 includes three angled and interconnected leaflets 210, and this disclosure is primarily 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 may also consist of two or more leaflets 210.

[0108] like Figure 5 As shown, the flattened shape of a single leaflet 210 is, for example, semi-circular or semi-circular, having an arcuate edge 22 corresponding to the second portion 212 and a free edge 21 corresponding to the first portion 211. The free edge is located at the distal end 1 and extends between the two ends of the arcuate edge 22. The arcuate edge 22 is rolled up to the outer periphery of the proximal end of the support 100 and attached to at least one of the corresponding second grid unit 110b, the corresponding first grid unit 110a, and the support rod 130.

[0109] The first portion 211 of the plurality of leaflets 210 is disposed within the stent 100. In the closed state, the free edges 21 of the plurality of leaflets 210 are in contact with each other to inhibit blood flow through the artificial heart valve 1000 in the direction from distal end 1 to proximal end 2. In the open state, the free edges 21 of the plurality of leaflets 210 are at least partially separated from each other to allow blood flow through the artificial heart valve 1000 in the direction from proximal end 2 to 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 may be fixed to the free edge 21 of an adjacent leaflet 210 to form a connecting portion 20, such that adjacent leaflets 210 can be connected to each other at the connecting portion 20, as... Figure 2 As shown. The joint 20 formed by the multiple leaflets 210 is attached to the support 100. For example, each joint 20 formed by the multiple leaflets 210 can be attached to each of the second grid units 110b.

[0112] As an example, such as Figure 2 and 4 As shown, the second portion 212 of each leaflet 210 can be folded from the interior space surrounded by the support 100 to the outside of the support 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 support 100.

[0113] In some embodiments, the plurality of support rods 130 may be completely or partially covered by the second portion 212 of the plurality of leaflets 210, the second portion 212 of the plurality of leaflets 210 extending a certain height on the outer side of the support in the axial direction.

[0114] Based on such Figure 4 In the exemplary support 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 to the distal end 1, to allow the second portion 212 of the leaflet 210 to fold from the inside to the outside of the support 100 at the proximal end 2 of the support 100 based on the arcuate profile formed by the first frame line 11 and the second frame line 12 according to the strut 130 and the second grid unit 110b, and at the same time allow the first portion 211 of the leaflet 210 to attach to the opposite side (i.e., the inside) of the support 100.

[0115] In order to stably fix the leaflet structure 200 to the support 100 and avoid direct contact between the support (e.g., made of metal) and the tissue (which may lead to calcification, stress concentration and affect durability), one or more covering layers can be provided circumferentially on the outside of the support 100 as a connection structure with the leaflet 210.

[0116] Figure 6 A schematic diagram showing the positional relationship between the cover layer and the support according to an embodiment of the present disclosure is provided. Figure 7a This demonstrates the use of artificial heart valves in situations such as Figure 6 The diagram shows a cross-sectional view of a support rod along the radial direction of the bracket. Figure 7b It is an artificial heart valve in an expanded state, located at a strut position along... Figure 6 The diagram shows a cross-sectional view of the bracket in the radial direction. Figure 8 As shown Figure 6 , 7a The structural diagram of the covering layer shown in Figure 7b.

[0117] In some alternative embodiments, a covering layer 300 is provided as a base for sutures to secure the leaflet 210 to the support 100. For example... Figure 6 and Figure 8 As shown, the covering layer 300 may be skirt-shaped and attached to the outer periphery of the support 100, connected to the second part 212 of each leaflet 210.

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

[0119] In some embodiments, the plurality of support rods 130 may be completely or partially covered by the cover layer 300.

[0120] As an example, the cover layer 300 may have a distal profile that matches the distal profile of the mesh structure 110 of the support 100 (including the distal arch of the first grid unit and the distal arch of the second grid unit) and a proximal profile that matches the proximal profile of the support 100. That is, the cover layer 300 may extend axially 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 alternative embodiments, such as Figure 6 , 7a As shown in 7b, at least the proximal portion of the covering layer 300 is sandwiched between a plurality of leaflets 210 and a plurality of struts 130, such that the second portion 212 of the leaflets and the covering layer 300 can be connected together via the struts by means of blanket sutures, locking sutures and / or other types of sutures, so as to be attached to the support 100.

[0122] In some embodiments, the cover layer 300 may be stitched to the stent 100 along the distal contour of the mesh structure 110 of the stent 100 (including the distal arches of the first mesh unit and the distal arches of the second mesh unit) and / or the 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 grid cell (110a, 110b) in the mesh structure 110 and / or the proximal frame edge (e.g., each proximal arch) of each grid cell in the mesh structure 110, so that the sutures arranged using this suturing method during the implantation phase will not be affected or pulled when the artificial heart valve 1000 is expanded to another state with a larger radial dimension after implantation (such as the second / third state described above).

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

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

[0126] According to embodiments of this disclosure, reference is made to Figure 2 , 4 6. Compared with the stent 100 in the first and / or second states, the leaflet 210 is larger in size than the stent fit size in that state, so that the leaflet structure 200 can expand together with the stent 100 after implantation without losing its functionality or being damaged during expansion.

[0127] In some embodiments, such as Figure 7a and 7b As shown, the edge of the second portion 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, but is not fixed to the proximal end of the stent, and the size of each leaflet 210 in at least one state exceeds the stent fit size in that state, so that in at least one state (first state and / or second state), at least one leaflet 210 can freely droop / drop in a 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 unrestricted with the stent 100 at the proximal end of the stent 100, that is, to allow the stent 100 to expand further to form a more functional valve. Therefore, the degree of freedom at the bottom provides space to accommodate redundant leaflet material and allows the redundant leaflet material to droop to form a more functional valve at a location 100 away from the stent (in expandable artificial heart valves, redundant leaflets can be located at the bottom of the stent, thus allowing greater degree of freedom at the bottom. This arrangement reduces the chance of leaflet twisting or blockage at the distal end, thereby improving the valve's performance in the open state and providing a more functional valve).

[0128] In some embodiments, the oversized leaflet 210, circumferentially rolled up at the strut 130 at the proximal end 2, can be pleated / folded in multiple places and sewn along the strut 130 and / or the cover layer 300 to allow for future expansion. For example, a second portion 212 of at least one leaflet 210 can be pleated / folded in multiple places at the outer peripheral side of the proximal end of the stent 100 to form folds extending along the strut 130, thereby enabling expansion with the stent 100 in the aforementioned different states. Furthermore, the multiple folded / pleated portions of the leaflet 210 at the proximal end can also serve as padding to prevent leakage / reflux.

[0129] According to embodiments of this disclosure, such as Figure 8As shown, the cover layer 300 can be provided with multiple openings 310, so that the cover layer 300 can expand together with the stent 100 after implantation without losing its function, and also avoid damage during expansion in different states.

[0130] Multiple openings 310 can be slits, holes, etc., and can all be designed to be the same shape or to be designed to be various shapes.

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

[0132] As an example, multiple openings 310 can 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 cell 110a may correspond in position to at least one corresponding opening 310.

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

[0135] According to embodiments of this disclosure, an assembly method for an artificial heart valve applicable to any embodiment of this disclosure is also provided. The specific steps can be performed according to the description of the various embodiments of the artificial heart valve described above, and will not be repeated here.

[0136] The artificial heart valve provided according to embodiments of this disclosure is used to replace the natural valve of the heart. The artificial heart valve mainly comprises a stent and leaflet structures. The stent has a mesh structure as circumferential sidewalls, making the stent 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 function in different states without needing replacement / removal. Based on these, after the artificial heart valve is implanted into the heart via surgery or transcatheter delivery, the artificial heart valve according to embodiments of this disclosure can remain functional (as a valve or as a docking adapter) as the patient (e.g., from 18 months to 16+ years or even up to 18+ years) grows. Therefore, patients do not need to frequently replace the implanted artificial heart valve via surgery or transcatheter delivery, saving medical costs and reducing suffering.

[0137] In some applications, artificial heart valves according to embodiments of the present disclosure are used to replace natural pulmonary valves, enabling the treatment of pulmonary valve stenosis through implantation and preventing post-implantation regurgitation if not replaced.

[0138] In some alternative embodiments, at least one leaflet has multiple folds / pleats on its outer periphery near the proximal end of the stent to form folds extending along the strut, thereby enabling it to expand together with the stent. The multiple folds / pleats near the proximal end of the leaflet can serve as padding to prevent leakage / reflux.

[0139] In some alternative embodiments, the artificial heart valve further includes a covering layer attached to the peripheral side of the stent and connected to a second portion of each leaflet to avoid problems such as calcification, stress concentration, and reduced durability caused by direct contact between the stent and tissue. In some embodiments, the covering layer may be designed with openings (e.g., slits, orifices) to support further expansion of the stent. In some embodiments, the covering layer may 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 sutures on opposite sides to be unaffected and unstretched during expansion of the artificial heart valve.

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

[0141] Given that the principles of this invention can be applied to many possible embodiments, it should be understood that the embodiments presented herein are merely preferred examples of the invention and should not be considered as limiting the scope of the invention. Rather, the scope of the 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 includes: An annular support (100), having a distal end (1) and a proximal end (2) in the axial direction, includes: a mesh structure (110) serving as a circumferential sidewall of the support, the mesh structure allowing the support to contract or expand in the radial direction; and The leaflet structure (200) includes a plurality of leaflets (210), each leaflet being attached to the support and having a first portion (211) disposed within the support and a second portion (212) rolled up to the outer peripheral side of the proximal end of the support. As the heart grows, the stent can be expanded to have an expanded radial dimension after the artificial heart valve is anchored to the heart, thereby allowing the artificial heart valve to function in different states without needing to be replaced. The edge end of the second portion of each of the leaflets is attached to the support at a position between the distal and proximal ends of the support, but is not fixed to the proximal end of the support. In at least one of the different states, the size of each leaflet exceeds the fit size of the stent in that state, and each leaflet has a redundant portion (210e) that hangs freely from the distal end to the proximal end away from the stent, such that the size of each leaflet allows the leaflet to be 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 also includes a plurality of struts (130) for attaching the plurality of leaflets, and each strut extends from the proximal end of the mesh structure toward the proximal end of the stent. In this embodiment, the second portion of each of the leaflets is rolled up at the proximal end of the plurality of struts to the outer periphery of the support at the proximal end.

4. The artificial heart valve according to claim 3, wherein, Each of the leaflets is semi-circular / quasi-semi-circular 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 portions of the plurality of leaflets are arranged within the stent, wherein the first portions of the plurality of leaflets are in contact with each other in a closed state to inhibit blood flow through the artificial heart valve in a distal-to-proximal direction, or are separated from each other in an open state to allow blood flow through the artificial heart valve in a proximal-to-distal direction. 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 includes a plurality of first mesh units (110a) and a plurality of second mesh units (110b) distributed circumferentially. Adjacent leaflets of the plurality of valves are connected to each other to form a junction (20), which is attached to a corresponding second grid cell, and the two ends of the second portion of each leaflet are respectively attached to two adjacent second grid cells.

6. The artificial heart valve according to claim 5, wherein, The plurality of first grid cells are uniformly divided into a plurality of first grid cell groups, each first grid cell group consisting of one or more first grid cells continuously distributed along the circumferential direction, and every two adjacent first grid cell groups are connected by a corresponding second grid cell.

7. The artificial heart valve according to claim 6, wherein, The plurality of supports are respectively connected to the proximal end of the corresponding first grid cell. For each of the first grid cell groups, the length of the corresponding support rod 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 spindle-shaped / rhomboid frame; The plurality of first grid cells are of the same size; or Each pair of adjacent grid cells shares a common frame edge extending from the far end to the near end, and one of the pairs of adjacent grid cells is the first grid cell or the second grid cell.

9. The artificial heart valve according to claim 5, wherein, The stent also includes a plurality of anchoring units (120) spaced apart at the distal end of the mesh structure, and each anchoring unit 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 cells and the plurality of second grid cells has a distal frame edge, the distal frame edge having a first arched angle pointing distally, and each of the anchoring cells is connected to a corresponding first arched angle; or Each of the first grid cells has a proximal frame edge, the proximal frame edge having a second arched angle pointing proximal to the proximal end, and each of the struts is connected to the corresponding second arched angle.

11. The artificial heart valve according to claim 5, wherein, Each of the second grid cells provides a concave frame edge at its proximal end to allow the second portion of the corresponding leaflet to fold over the concave frame edge to the outer periphery of the support.

12. The artificial heart valve according to claim 11, wherein, The concave frame edge includes: At the first connection point (A) near the end, it is connected to an adjacent first grid cell; At the second connection point (A') near the end, it connects to another adjacent first grid cell; The first frame line (11) and the second frame line (12) extend from the first connection point and the second connection point, respectively, to form a corner pointing towards the far end. In this configuration, the second portions of two adjacent leaflets are respectively rolled up to the outer periphery of the support at the proximal end via the corresponding positions of the first frame line and the second frame line.

13. The artificial heart valve according to claim 5, wherein, It also includes a cover layer (300) that is attached to the surface of the support 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 overlay 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, The proximal portion of the covering layer is sandwiched between the support and the second portion of the plurality of leaflets.

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

17. The artificial heart valve according to claim 13, wherein, The cover layer has multiple openings (310) to allow the cover layer to expand with the support.

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 multiple columns, with each column of 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 proximal ends of the plurality of struts are respectively provided with cavities (10), and the cavities of the plurality of struts are connected by sutures or wires, thereby providing structural support for the plurality of leaflets.

20. The artificial heart valve according to claim 19, wherein, The covering layer is stitched to the bracket based on the cavity of the plurality of struts.

21. The artificial heart valve according to claim 3, wherein, At least one of the second portions of the leaflets is folded / pleated in multiple places on the outer periphery of the proximal end of the support to form folds, which serve as padding to prevent leakage / backflow, and each fold extends along the strut to facilitate expansion with the support.

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: The first state has a first radial dimension for replacing the natural valve during the implantation stage; The second state has a second radial dimension adjusted by expansion according to the growth of the heart after the implantation stage; The third state, with a third radial dimension, serves as a docking adapter for flap-in-flap surgery. Wherein, the second radial dimension is greater than the first radial dimension and less than the third radial dimension.

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

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