Transcatheter artificial atrioventricular valve with reinforcement structure

Abstract

A prosthetic atrioventricular valve may include a collapsible frame including an atrial disc, a ventricular disc, and a central portion therebetween. The frame may include a close seam attachment feature ("CAF") including a strut extending from a central portion. The artificial blade may be mounted to the CAF. A sealing fabric may be coupled to the frame. The seaming support ring may be coupled to the plurality of CAFs and extend around the plurality of CAFs. Each of the atrial disc and the ventricular disc may be flared outwardly from the central portion of the frame. The central portion of the frame may define a minimum diameter of the frame. Each of the CAFs may be spaced apart from adjacent ones of the CAFs such that a gap in the frame is present between adjacent ones of the CAFs.

Description

[0001] Cross - Reference to Related Applications

[0002] This application claims the benefit and priority of U.S. Provisional Patent Application No. 63 / 384,521, filed on Nov. 21, 2022, the content of which is incorporated herein by reference. BACKGROUND OF THE INVENTION

[0003] Heart valve disease is an important cause of morbidity and mortality. One treatment for this disease is valve replacement. One form of replacement device is a bioprosthetic valve. Compared to traditional open-chest, open-heart surgery, being able to fold these valves into smaller sizes or into a delivery system enables a less invasive delivery method. Folding the implant to a smaller size and using a smaller delivery system minimizes the size of the entry site and reduces the number of potential peri-operative complications.

[0004] The size to which an implant can be folded is limited by the volume of the materials used in the implant, the strength and shape of those materials, and the need to function after deployment (or redeployment). Using multiple steps and / or multiple delivery system devices may increase the time and complexity of the surgery.

[0005] Compared to native aortic and pulmonary valves, native atrioventricular valves (i.e., tricuspid and mitral valves) generally have larger sizes and / or diameters. Among native atrioventricular valves, a regurgitant tricuspid valve typically has a larger size and / or diameter than a regurgitant mitral valve. For example, for patients with severe tricuspid valve regurgitation, the diameter of the tricuspid valve can be in the range of about 40 mm to about 66 mm, although these numbers are merely exemplary. Thus, the design and considerations for artificial heart valves for replacing different native heart valves are not entirely the same. For example, to accommodate the large sizes of mitral and tricuspid valves, recent artificial heart valve designs have included a large-sized outer frame for engaging the native mitral or native tricuspid valve annulus, and a smaller, generally cylindrical inner frame within the outer frame that houses the artificial valve leaflets. However, such a dual-stent design generally increases the volume of the artificial heart valve, resulting in a larger profile when folded within the delivery device. This in turn requires the delivery device (e.g., a catheter that houses the folded artificial heart valve for delivery) to be of a larger size to accommodate the large artificial heart valve. Generally, it is desirable for the catheter of a transcatheter heart valve delivery device to be of a smaller size, as the catheter may need to pass through the vasculature to reach the native heart valve in a minimally invasive manner. Thus, there is a desire for an artificial heart valve that can fit within a native tricuspid or native mitral valve but can be folded into a small size to fit within a delivery device of relatively small profile. SUMMARY OF THE INVENTION

[0006] According to one aspect of the present disclosure, an artificial heart valve for replacing a native atrioventricular valve includes a collapsible and expandable frame that includes an atrial disk, a ventricular disk, and a central portion extending between the atrial disk and the ventricular disk. The frame includes a plurality of commissural attachment features that include struts extending from the central portion of the frame. A plurality of artificial leaflets can be mounted to the plurality of commissural attachment features. A sealing fabric can be coupled to an outer surface of the frame. A commissural support ring can be coupled to the plurality of commissural attachment features and can extend around the plurality of commissural attachment features. In an expanded state of the artificial heart valve, (i) each of the atrial disk and the ventricular disk can flare outwardly from the central portion of the frame, (ii) the central portion of the frame can define a minimum diameter of the frame, and (iii) each of the plurality of commissural attachment features can be spaced apart from an adjacent commissural attachment feature of the plurality of commissural attachment features such that a gap exists in the frame between adjacent commissural attachment features of the plurality of commissural attachment features. The commissural support ring can be a collapsible and expandable structure that has a circular shape in an expanded state of the commissural support ring. The commissural support ring can be a collapsible and expandable structure that has a leaflet shape in an expanded state of the commissural support ring. In an expanded state of the commissural support ring, a first portion of the commissural support ring that is aligned with the plurality of commissural attachment features can have a minimum diameter of the commissural support ring, and a second portion of the commissural support ring that is aligned with an intermediate portion of free edges of the plurality of artificial leaflets can have a maximum diameter of the commissural support ring. The commissural support ring can include a first circumferential row of generally diamond-shaped cells. The commissural support ring can include a second circumferential row of generally diamond-shaped cells, the second circumferential row being adjacent to the first circumferential row. The commissural support ring can include a plurality of connectors integrally formed with the commissural support ring, and each of the plurality of connectors can have a shape complementary to a shape of each of the plurality of commissural attachment features. The frame can include a plurality of cusp teeth on the ventricular disk, each of the plurality of cusp teeth extending to a free end pointing toward the atrial disk in a folded state of the frame. In an expanded state of the artificial heart valve, at least some of the plurality of cusp teeth can extend at an acute angle relative to a central longitudinal axis of the artificial heart valve. In an expanded state of the artificial heart valve, at least some of the plurality of cusp teeth can extend at an obtuse angle relative to a central longitudinal axis of the artificial heart valve. The struts extending from the central portion of the frame can include at least one hole. The commissural support ring can be coupled to the plurality of commissural attachment features via a mechanical fastener extending through the at least one hole. In an expanded state of the artificial heart valve, the ventricular disk of the frame can be bell-shaped. The sealing fabric can extend above the ventricular disk and above the central portion of the frame, and an inflow edge of the sealing fabric can be positioned at a distance from an end of the atrial disk. In an implanted state of the artificial heart valve, at least a portion of the sealing fabric can be configured to parachute during ventricular systole to contact a structure of the native atrioventricular valve.

[0007] According to another aspect of the present disclosure, a method of implanting an artificial heart valve may include loading an artificial heart valve into a delivery device. The artificial heart valve may include a collapsible and expandable frame having an atrial disk, a ventricular disk, a central portion extending between the atrial disk and the ventricular disk, a plurality of commissure attachment features including struts extending from the central portion of the frame, and a plurality of artificial leaflets mounted to the plurality of commissure attachment features. The method may include advancing the delivery device to the patient's native heart valve while maintaining the artificial heart valve in a collapsed state by the delivery device, and when the delivery device is positioned within or adjacent to the native heart valve, beginning to deploy the artificial heart valve in the patient's ventricle such that the ventricular disk begins to expand and such that a sealing fabric coupled to the outer surface of the frame moves toward the native heart valve. The method may include continuing to deploy the artificial heart valve such that the central portion is positioned against the annulus of the native heart valve and the atrial disk expands within the patient's atrium. At the same time as beginning to deploy the artificial heart valve, a commissure support ring may be coupled to the plurality of commissure attachment features and may extend around the plurality of commissure attachment features to limit the distance that the plurality of commissure attachment features may expand outward. At the same time as beginning to deploy the artificial heart valve, at least one of a plurality of cusp teeth on the ventricular disk may frictionally engage the tissue of the native heart valve. The commissure support ring may be a collapsible and expandable structure that has a circular shape after the artificial heart valve is fully deployed within the native heart valve. The commissure support ring may be a collapsible and expandable structure that has a leaflet-shaped form after the artificial heart valve is fully deployed within the native heart valve. After the artificial heart valve is fully deployed within the native heart valve, a first portion of the commissure support ring that is aligned with the plurality of commissure attachment features may have a minimum diameter of the commissure support ring, and a second portion of the commissure support ring that is aligned with an intermediate portion of the free edges of the plurality of artificial leaflets may have a maximum diameter of the commissure support ring such that when the plurality of artificial leaflets open during atrial systole, the intermediate portion of the free edges of the plurality of artificial leaflets reaches a position radially outward of the first portion of the commissure support ring and radially inward of the second portion of the commissure support ring. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Figure 1 is a cross-sectional view of an artificial heart valve taken along section line 1-1 of Figure 2 .

[0009] Figure 2 is Figure 1 a schematic side view of the artificial heart valve of

[0010] Figure 3 is Figures 1 to 2 a side view of the artificial heart valve of

[0011] Figure 4is Figures 1 to 2 Top or atrial view of an artificial heart valve.

[0012] Figure 5 is Figures 1 to 2 Bottom or ventricular view of an artificial heart valve.

[0013] Figure 6 is Figures 1 to 2 Three-dimensional view of the stent of an artificial heart valve, with other components of the artificial heart valve omitted.

[0014] Figure 7 is Figure 6 View of a part of the cutting pattern of the stent.

[0015] Figure 8A is an artificial heart valve having a configuration different from that of Figures 1 to 7 Three-dimensional view of an artificial heart valve.

[0016] Figure 8B is Figure 8A View of a part of the cutting pattern of a stent used with the artificial heart valve of

[0017] Figure 8C is Figure 8A View of the cutting pattern of an alternative version of the stent used with the artificial heart valve of

[0018] Figure 8D shows Figure 8A the artificial heart valve of , with certain structures omitted from the view for clarity.

[0019] Figure 9A is the view of the deployment of the artificial heart valve of without a commissure support structure from a delivery device. Figure 8A

[0020] Figure 9B is Figure 8A the view of the manual deformation of the artificial heart valve of without a commissure support structure.

[0021] Figures 10A to 10C shows different cutting patterns that can be used to form a commissure support structure for use with an artificial heart valve such as Figure 8A shown in .

[0022] Figure 10D illustrates Figure 8C the Figure 10C commissure support structure covering the frame of .

[0023] Figure 10E illustrates alternative shapes for the commissure support structure.

[0024] Figures 11A to 11B The artificial heart valves with a commissure support structure are shown before and after the application of a manual compression force to the artificial heart valve, respectively.

[0025] Figure 12 As shown Figure 8D The artificial heart valve shown is in a state after having been implanted above a previously implanted leaflet repair device.

[0026] Figure 13A It is a view of a cutting pattern of a frame with alternative commissure attachment features.

[0027] Figure 13B It is Figure 13A an enlarged view of the commissure attachment feature of the frame of

[0028] Figure 13C It is a view of a cutting pattern that can be used to form an alternative commissure support structure.

[0029] Figure 13D It is Figure 13C an enlarged view of a part of the cutting pattern of

[0030] Figure 13E It illustrates Figure 13C the cutting pattern of the commissure support structure of Figure 13A being superposed on the cutting pattern of the frame of

[0031] Figure 13F It illustrates Figure 13C the cutting pattern of the commissure support structure of Figure 13A being superposed on the cutting pattern of the frame of

[0032] Figures 13G to 13H It is a view of the commissure support structure of Figure 13A the frame that is coupled to Figure 13C in an expanded state. DETAILED DESCRIPTION

[0033] As used herein, when used in connection with an artificial heart valve, the term "inflow" refers to the end of the artificial heart valve that is first flowed through when blood flows in the antegrade direction, and the term "outflow" refers to the end of the artificial heart valve that is last flowed through when blood flows in the antegrade direction. Further, although the present disclosure focuses on artificial tricuspid valve replacement, the present disclosure can equally apply to artificial mitral valve replacement. Moreover, unless otherwise explicitly stated, even though a particular embodiment may be more suitable for replacing a native tricuspid valve or a native mitral valve, the embodiments described herein can be used to replace a native tricuspid valve or a native mitral valve (with or without additional modifications specific to the heart valve being replaced).

[0034] As explained in the background of the present disclosure, an artificial heart valve including an anchoring frame and a valve frame nested within the anchoring frame typically has a larger size (e.g., a larger crimp diameter) when folded within a delivery device. As an example, this type of artificial heart valve can only be assembled within a delivery device of a catheter having an inner diameter of 30-33 French (10-11 mm in diameter) or larger. For a transcatheter mitral or tricuspid valve for transvenous delivery, a delivery catheter having an outer diameter of 30-33 French or larger can increase the likelihood of complications at the entry site, which may require surgical intervention and surgical resection to access the vasculature and subsequent surgical repair after the procedure is completed. The artificial heart valves disclosed herein have the following features and configurations: these features and configurations are designed to allow the artificial heart valve to be reliably anchored within a larger-sized annulus of a tricuspid valve (or mitral valve), while being able to be folded into a delivery catheter having an inner diameter of 30-33 French or smaller. It should be understood that, as used herein, when describing the ability of a valve to be assembled within a catheter, the unit French refers to the inner diameter of the catheter, and when describing how the catheter size may cause vascular access problems, the unit French refers to the outer diameter of the catheter.

[0035] As described below, one way to achieve this function is to design an artificial heart valve having a single support stent (e.g., a single stent layer or a non-nested frame configuration) that can span the diameter of the large atrioventricular valve annulus found in patients experiencing heart failure. The geometry of the support stent can allow artificial leaflets to be fixed internally, and its atrial flange or disk and / or ventricular flange or disk have a large enough diameter or profile to sandwich, clamp, or overlie the native valve annulus tissue therebetween. To provide sufficient sealing between the support stent and the native valve annulus, a fabric can span the gap between the atrial and ventricular disks, where the fabric can elongate to mitigate the effect of shortening when the artificial heart valve is nested within the catheter. Although the embodiments described below may be suitable for replacing a tricuspid or mitral valve, these embodiments may be most suitable for replacing the tricuspid valve because the right ventricular pressure is lower compared to the left ventricular pressure, which can reduce the need for a nested stent design. It should be understood that although the terms "frame" and "stent" are generally used interchangeably herein, the term "stent" does not imply any special structure or function beyond a frame.

[0036] Figure 1 is along one aspect of the present disclosure Figure 2Cross-section of the artificial heart valve 10 taken along the section line 1-1. Generally, the artificial heart valve 10 includes a support frame or stent 100, which may include an atrial flange 110 (which may alternatively be referred to as an atrial disk or atrial anchor), a ventricular flange 120 (which may alternatively be referred to as a ventricular disk or ventricular anchor), and a central stent portion 130 (which may alternatively be referred to as a central waist). The stent 100 may also include a plurality of commissural attachment features ("CAF") 140 for coupling the artificial valve leaflets 500 to the stent 100. The artificial valve leaflets 500 are omitted in the Figures 1 to 2 illustration and are best shown in Figures 4 to 5 . The stent 100 is better described below in connection with Figures 6 to 7 . Still referring to Figure 1 , the artificial heart valve 10 may include a first fabric 200 that generally surrounds the central portion 130 of the stent 100 and spans the gap between the atrial disk 110 and the ventricular disk 120. In one embodiment, the first fabric may be formed as a knitted fabric (e.g., polyethylene terephthalate ("PET"), polytetrafluoroethylene ("PTFE"), ultra-high molecular weight polyethylene ("UHMWPE"), polyester, or similar materials). Forming the first fabric 200 as a knitted fabric may allow significant stretching of the first fabric, e.g., up to two or three times its length when stretched. In one embodiment, the first fabric 200 is configured to stretch to increase its length by about 2.5 times. When in the Figure 1 expanded or deployed state shown, at least prior to implantation, there may be a substantial amount of open space or volume between the first fabric 200 and the exterior of the stent 100. A second fabric 300 may be disposed on the outer surfaces of the atrial flange 110 and the ventricular flange 120, and the second fabric 300 is coupled to the first fabric 200 at a seam 400, which may be, for example, an ultrasonic weld seam. In one embodiment, the second fabric 300 may be formed as a woven fabric (e.g., PET, PTFE, UHMWPE, etc.). By forming the second fabric 300 as a woven fabric, the second fabric 300 may be particularly suitable for providing a sealing function against the native anatomy, while the knitted fabric 200 is particularly suitable for providing stretching ability to allow relatively unobstructed folding and expansion of the stent 100. Even if the first fabric 200 is formed as a knitted fabric and the second fabric 300 is formed as a woven fabric, it may be desirable (although not necessary) for the two fabrics to be formed of the same material, where the stretching characteristics and / or sealing characteristics are at least partially affected by the manner in which the threads of the fabric are wound, knitted, and / or woven. For example, changing the deviation of the warp threads relative to the weft threads will change the stretching ability of the fabric.

[0037] Briefly referring to Figure 2, provides various exemplary dimensions of the artificial heart valve 10 when the artificial heart valve 10 is in an expanded or deployed configuration. However, these dimensions are merely exemplary, and other dimensions may be suitable. For example, the outer anchor diameter AD of the atrial disk 110 and / or the ventricular disk 120 may be about 65 mm. However, in other embodiments, the anchor diameter AD may be between about 50 mm and about 80 mm. In the expanded or deployed state (e.g., when implanted into the native tricuspid valve annulus), the first fabric 200 may form a waist shape with a minimum waist diameter WD near the axial center of the first fabric 200. In the illustrated embodiment, the waist diameter WD may be about 52 mm, but in other embodiments, the waist diameter WD may be between about 45 mm and about 75 mm. The central portion 130 of the stent 100 may generally be cylindrical and have a central diameter CD of about 29 mm in the illustrated embodiment, but in other embodiments, the central diameter CD may be between about 25 mm and about 35 mm. The artificial heart valve 10 may have a height H of about 30 mm between the inflow end and the outflow end, but in other embodiments, this height may be between about 25 mm and about 45 mm. As described above, each of these dimensions is merely illustrative. In some embodiments, in the expanded or deployed state, the ratio of the outer anchor diameter AD to the central diameter CD is between about 2.5:1 and about 1.5:1, preferably between about 2.5:1 and about 2.0:1, including about 2.25:1. As explained in more detail below, this large difference may allow the atrial disk 110 and the ventricular disk 120 to be large enough to provide anchoring, but the central portion 130 to be small enough to accommodate a set of appropriately sized artificial valve leaflets 500 while still maintaining a small crimp profile for delivery, e.g., capable of being delivered within a delivery device catheter having an inner diameter as small as 24 French (8.0 mm) or even as small as 18 French (6.0 mm) and successfully deployed within the delivery device catheter. In some embodiments, the artificial heart valve 10 may be successfully accommodated within a catheter having an inner diameter between 22 French (7.33 mm) and 32 French (10.66 mm) (including between about 24 French (8.0 mm) and 28 French (9.33 mm)).

[0038] Figure 3 is a side view of the artificial heart valve 10. Figure 3Illustrated is an artificial heart valve 10 in an expanded or deployed state, wherein a first fabric 200 extends between an atrial disk 110 and a ventricular disk 120. In the illustrated embodiment, the first fabric 200 is an elastic fabric that can be easily elongated when the artificial heart valve 10 is folded and can be easily shortened when the artificial heart valve 10 is expanded. To achieve such elongation and shortening, it is preferred that the first fabric 200 is not directly coupled to the stent 100. For example, the fabric 200 is preferably not directly sutured to the struts of the stent 100. A second fabric 300 includes portions that are coupled, for example by suturing, to the exterior of the atrial disk 110 and portions that are coupled to the exterior of the ventricular disk 110. As described above, the second fabric 300 can be used to assist in forming or enhancing a seal between the native valve annulus and the atrial and ventricular portions of the artificial heart valve 10. Figure 3 An interface 400 between portions of the first fabric 200 and the second fabric 300 is shown. In the example shown, the interface 400 is a seam formed by ultrasonic welding, but the fabrics can be joined to each other in any suitable manner, including suturing, adhesion, etc. In some embodiments, a single outer fabric can be used, where the single outer fabric has sufficient stretchability to allow the stent 100 to expand and fold without significant restriction, but also provides a suitable seal with the native valve annulus.

[0039] Figure 4 Illustrated is the artificial heart valve 10 in an expanded or deployed state as viewed from the atrial side or the inflow side, wherein the artificial leaflets 500 are in an open state. Figure 5Illustrated is an artificial heart valve 10 in a dilated or deployed state as viewed from the ventricular side or the outflow side, wherein the artificial leaflets 500 are in an open state. In the illustrated embodiment, the artificial heart valve 10 includes three artificial leaflets 500, but in some embodiments, the artificial heart valve 10 may include more or fewer artificial leaflets. The artificial leaflets 500 may be formed of any suitable material. For example, each artificial leaflet 500 may be formed of bioartificial tissue (such as porcine pericardium or bovine pericardium). In other embodiments, each artificial leaflet 500 may be formed of synthetic materials (such as synthetic materials or fabrics, including PET, UHMWPE, PTFE, etc.). Each artificial leaflet 500 may have two sides (such as forming leaflet tabs), each side being coupled to one end of an adjacent artificial leaflet 500 to form a commissure, and each leaflet commissure being coupled to a corresponding CAF 140 of the stent 100. Each leaflet may include an outflow edge between two side edges, and the outflow edge is free to allow the leaflet to open and close during normal operation (such as to provide valve function). Each leaflet may include an inflow edge between two side edges, and the inflow edge is coupled (such as sutured) to the stent 100. In some embodiments, the inflow edge of the artificial leaflet 500 is individually coupled (such as via suturing) to the struts of the central portion 130 of the stent 100 without being directly attached to other components. In other embodiments, a short fabric skirt may be provided around a portion of the inflow side of the central portion 130 of the stent 100, wherein the short fabric skirt is coupled to the stent 100 and provides additional structure that can be used to couple the inflow end of the artificial leaflet 500 (such as via suturing) to the artificial heart valve 10.

[0040] By comparison Figure 4 with Figure 5 , it can be seen that the atrial disk 110 is "closed" while the ventricular disk 120 is "open". In other words, as Figure 4 shown, the inflow end of the artificial leaflet 500 is directly coupled to the stent 100 (and / or the separate short fabric skirt as described above), such that at the atrial disk 100, there is no open flow path between the artificial leaflet 500 and the external fabric skirt (such as the first fabric 200 and the second fabric 300, or a single external fabric if only a single external fabric is used). On the other hand, as Figure 5As shown, there is a significant radial gap between the outflow end of the artificial leaflet 500 and the first fabric 200 and the second fabric 300. With this configuration, after the artificial heart valve 10 is implanted into the native tricuspid valve, as the right ventricle contracts, the artificial leaflet 500 is forced closed, and blood tends to flow in a retrograde direction into the space between the artificial leaflet 500 and the first fabric 200. The "closed" configuration at the atrial disc 110 ensures that blood cannot actually enter the right atrium, but the "open" configuration at the ventricular disc 120 allows the retrograde blood to press the first fabric 200 outward and into the native valve annulus to enhance the seal between the artificial heart valve 10 and the native tricuspid valve annulus.

[0041] Figure 6 FIG. 4 is a perspective view of the stent 100 of the artificial heart valve 10 in the expanded state, with other components of the artificial heart valve 10 omitted from the figure. The orientation of the stent 100 is opposite to that shown in Figures 1 to 3 In other words, Figure 6 the top of the view of Figure 6 is the outflow end, and Figure 6 the bottom of the view of Figure 7 FIG. 5 shows the cutting pattern of a portion of the stent 100.

[0042] With continued reference to Figures 6 to 7, the stent 100 can be formed with multiple rows of generally diamond-shaped cells. In the illustrated example, the atrial disk 110 includes an inflow row of cells 112, which can include a total of twelve cells. Pins 114 can be formed at the inflow vertices of one, some, or each cell 112, the pins extending a short distance in the outflow direction to a free end. Each pin 114 can be sized and shaped such that a suture loop of the delivery device can slide over the pin 114 to hold the stent 110 connected to the delivery device during delivery and deployment. When deploying the artificial heart valve 10, each suture loop can be pushed forward or distally to disengage from the corresponding pin 114 to completely decouple the artificial heart valve 10 from the delivery device. Similar pins and suture loops are described in more detail in U.S. Patent No. 10,874,512, the disclosure of which is incorporated herein by reference.

[0043] The transition rows of cell 116 can be positioned directly adjacent to the inflow rows of cell 112, where cell 116 transitions between atrial disk 110 and central portion 130. In the illustrated embodiment, a total of twelve atrial transition cells 116 are provided. The central portion 130 can generally be formed by a row of central cells, but each central cell may not be identical to every other central cell. In the illustrated example, there are a total of twelve central cells, with a total of nine connected central cells 132a and three free central cells 132b. Each connected central cell 132a can be diamond-shaped and have both an inflow vertex and an outflow vertex of central cell 132a that are directly connected to another cell of the stent. Each free central cell 132b can have an inflow vertex that is directly coupled to the outflow vertex of the inflowing cell 112, where the outflow vertex of free central cell 132b transitions into CAF 140. With this configuration, there are three free central cells 132b that are evenly spaced around the circumference of stent 100, and three consecutive connected central cells 132a positioned between each pair of free central cells 132b. In the illustrated embodiment, each CAF 140 is cantilevered, i.e., it is coupled to stent 100 on one side only via two struts of the corresponding free central cell 132b. This cantilevered configuration can allow for a greater leaf height while maintaining a relatively small distance between atrial disk 110 and ventricular disk 120. The cantilevered configuration can also allow CAF 140 to maintain a greater deflection during normal operation of the artificial heart valve 10, which can reduce stress on the artificial leaflet 500. Each CAF 140 can include one or more perforations to assist in suturing or otherwise coupling the commissure of artificial leaflet 500 to CAF 140. Each CAF 140 can also include a separate fabric coupled to CAF 140 to assist in suturing artificial leaflet 500 to CAF 140. In the illustrated embodiment, each CAF 140 includes a 2×2 array of four small perforations, with a larger perforation positioned between the array of four small perforations and the two struts of free central cell 132b. However, other configurations of perforations and other types of CAFs can be suitable as alternatives to CAF 140.

[0044] Still referring to Figures 6 to 7, the rows of the ventricular transition units 122 can be directly positioned adjacent to the intermediate units. In the illustrated embodiment, there are a total of six ventricular transition units 122 provided in pairs, with each ventricular transition unit 122 positioned between two adjacent connected central units 132. In this example, there is no ventricular transition unit 122 directly adjacent to the free central unit 132b. The ventricular transition units 122 can form part of the cylindrical central portion 130 and flare outwards to form part of the ventricular disc 120. In the illustrated embodiment, the last row of ventricular units includes small ventricular units 124a and large ventricular units 124b. For example, a total of nine small ventricular units 124a can be provided, each small ventricular unit 124a having an inflow apex that is directly connected to the outflow apex of the connected central unit 132a. The large ventricular units 124b are positioned between the small ventricular units 124a in each series (e.g., a series of three elements). When the stent 100 is folded, the portion of the free central unit 132b including the CAF 140 can be nested within the large ventricular unit 124b. Further, in the illustrated embodiment, a total of three large ventricular units 124b are provided. Although a specific configuration of the units has been shown and described in connection with Figures 6 to 7 a particular configuration of the units is shown and described, it should be understood that other configurations of the units can provide suitable functionality for the artificial heart valve 10. Using the above embodiment, the stent 100 can be formed as a single integral structure or monolithic structure which, when expanded or deployed, has an hourglass-shaped configuration with two opposing discs having large diameters for anchoring on the atrial and ventricular sides of the native annulus, wherein the generally cylindrical central portion extending between the atrial and ventricular sides has a diameter significantly smaller than that of the discs. As explained in more detail below, after implantation, the central portion 130 of the stent 100 can be positioned at a distance from the native valve annulus, which is typically in contrast to a typical valve where, after implantation of the artificial heart valve, there is a stent structure that directly abuts against the native valve annulus tissue. Instead, as described below, at the time of implantation, the first fabric 200 directly contacts the native valve annulus tissue, leaving a space between the first fabric 200 and the central portion 130 of the stent 100. By avoiding having two separate stents that overlap and increasing the volume of the artificial heart valve when folded into the delivery device, the artificial heart valve 10 can be folded into a catheter for delivery having an inner diameter of less than 30 French, including for example an inner diameter of 28 French or 24 French or even smaller. Other benefits of this single stent design can include lower cost and a viable retrieval of the artificial heart valve, as compared to a design with two nested stents, the connector between the two nested stents can make retrieval more difficult.

[0045] Briefly returning to Figures 1 to 3, To allow the stent 100 to be folded into a delivery device and then expand upon deployment, the outer fabric is preferably designed not to overly restrict the folding and expansion of the stent 100. For example, the sealing fabric disposed on the stent of an artificial heart valve is typically a woven fabric and is typically tightly stitched or otherwise attached to the stent such that the fabric does not have the ability to significantly stretch or deviate from its position relative to the stent. Additionally, these fabrics are typically designed to seal to prevent blood flow as a primary fabric characteristic. In contrast, the artificial heart valve 10 has an outer fabric that is capable of significant stretching to accommodate the shape changes of the stent 100 during the transition between the folded state and the expanded state, where the fabric is spaced a significant distance from the central portion 130 when the artificial heart valve 10 is deployed. For example, referring to Figure 1 , when the artificial heart valve 10 is deployed into the native valve annulus, the atrial disk 110 and the ventricular disk 120 can generally wrap around the atrial and ventricular sides of the native valve annulus, where the outer fabric presses against the native valve annulus (e.g., via systolic pressure against the fabric on the outflow side), and the central portion 130 of the stent 100 is generally centered within the tissue of the valve annulus (but not pressing directly against it). This configuration can allow the central portion 130 of the stent 100 to have a smaller size (e.g., about 28 mm to 32 mm), which may be optimal for hemodynamics, without the need to add additional stent structures to allow for proper sealing and / or anchoring in a much larger tricuspid valve annulus. This in turn can allow the artificial heart valve 10 to be folded into a small size for loading into a relatively small delivery device to minimize the likelihood of surgical complications (especially vascular access complications) due to the size of the delivery device. The outer fabric can be formed as a single-piece knitted fabric that allows stretching in one direction, has the ability to seal the native anatomy and cause blood to quickly clot to the fabric to reduce the likelihood of paravalvular ("PV") leak past the artificial heart valve 10 after implantation. However, in other embodiments, as Figure 1 shown, the outer fabric can include a first fabric 200 and a second fabric 300 located at the atrial disk 110 and the ventricular disk 120, the first fabric 200 being made of a material selected for its stretching ability (e.g., a knitted fabric), the second fabric 300 being selected for its sealing, ingrowth, and / or clotting characteristics (e.g., a woven fabric), where the first fabric 200 is attached to the second fabric 300 in any desired manner that allows stretching to occur.

[0046] Although the artificial heart valve 10 is described above as having a specific frame or stent 100 and a specific configuration of sealing fabrics (e.g., a first fabric 200 and a second fabric 300), it should be understood that these are merely exemplary configurations and that other configurations may be suitable. For example, additional configurations of the frame and the sealing fabrics are described in more detail in U.S. Provisional Patent Application No. 63 / 341,702, filed on May 13, 2022, entitled "Transcatheter Valve - Single Stent Structure with Fabric", the disclosure of which is incorporated herein by reference.

[0047] Figure 8A An artificial heart valve 1010 is illustrated in accordance with another embodiment of the present disclosure. Like the artificial heart valve 10, the artificial heart valve 1010 may be particularly suitable for replacing a native atrioventricular valve, and in particular, the native tricuspid valve. The artificial heart valve 1010 generally may include four components, including a stent or frame 1100, a sealing skirt 1200, an artificial leaflet 1500 (shown in Figures 9A to 9B ), and a commissural support member 1600 (shown in Figure 8D ), which may also be referred to as a reinforcement structure. The artificial heart valve 1010 is shown in Figure 8A in an expanded or deployed state and is oriented such that the atrial end or inflow end of the valve faces towards the top of the view of Figure 8A .

[0048] Figure 8B A portion of a cut pattern of a stent or frame 1100 that may be used with the artificial heart valve 1010 is illustrated. Figure 8C A cut pattern of a stent or frame 1100 that may be used with the artificial heart valve 1010 is illustrated. Although Figures 8B to 8C the frames have minor differences, these frames are highly similar, and thus the same part markings are used for common features between the frames.

[0049] In Figures 8B to 8C , the frame 1100 has the same orientation as that shown in Figure 8A . In other words, in the view of Figures 8B to 8C , the inflow end or atrial end of the frame 1100 is oriented towards the top of the view. The frame 1100 is preferably formed of a shape memory material (e.g., a nickel-titanium alloy such as nitinol) and may be formed from a single tube, such as by laser cutting a nitinol tube. In Figures 8B to 8CIn the cutting pattern shown, the frame 1100 generally includes an atrial portion 1110 and a ventricular portion 1120 separated by a central portion 1130. After the frame 1100 is cut and set to the desired shape, for example as shown and described in more detail in connection with Figure 8D the central portion 1130 can be very short, particularly compared to the central portion 130 of the frame 100 shown in Figures 1 to 2 .

[0050] The frame 1100 can include a row of atrial units 1112 that are closest to the atrium or the inflow end, which can be generally diamond-shaped units that radially expand outward from the central portion 1130 in the expanded state. Pins 1114 can be formed at the inflow vertices of one, some, or each of the atrial units 1112 closest to the atrium, and the pins 1114 extend a short distance in the outflow direction to a free end. Each pin 1114 can be sized and shaped such that the suture loop of the delivery device can slide over the pin 1114, thereby maintaining the connection of the frame 1100 to the delivery device during delivery and deployment. When deploying the artificial heart valve 1010, each suture loop can be pushed forward or distally to disengage from the corresponding pin 1114 to completely decouple the artificial heart valve 1010 from the delivery device. Similar pins and suture loops are described in more detail in U.S. Patent No. 10,874,512, the disclosure of which is incorporated herein by reference. The atrial units 1112 can terminate at turning points 1132 (marked in Figure 8C ). When the frame 1100 is shaped into the desired shape (which can generally be similar to the shape shown in Figure 8D ), the turning points 1132 can define the minimum diameter of the central portion 1130. It should be understood that the term "turning point" is not necessarily used according to its mathematical definition, but rather refers to the point at which the frame 1100 changes from a decreasing diameter to an increasing diameter.

[0051] Still referring to Figures 8B to 8C , a plurality of generally diamond-shaped transition units 1116 can be positioned in a row adjacent to the atrial units 1112 in the outflow direction. The transition units 1116 can include an inflow portion located on the inflow side of the central portion 1130 and an outflow portion located on the outflow side of the central portion 1130. In some examples, the transition units 1116 can be axially centered around the turning points 1132. The row of transition units 1116 can include three enlarged transition units 1117 (or more or less than three, depending on the number of artificial leaflets included in the artificial heart valve 1010) that terminate in coaptation attachment features ("CAF") 1140. Preferably, the enlarged transition units 1117 are positioned around the frame 1100 at substantially equal circumferential intervals. As Figure 8CAs best shown, the sides of the atrial unit 1112 (which may extend to the inflow apex of the transition unit 1116 and the enlarged transition unit 1117) may include elongated beams 1115. These elongated beams 1115 may provide additional flexibility to the atrial portion 1110 (which may be referred to as the atrial disk). For example, depending on the number of units included in the atrial portion and the diameter that the desired atrial portion is to span, the length of the beams 1115 may be adjusted. As the diameter of the desired atrial portion 1110 increases, if a specific opening angle of the diamond-shaped units (e.g., about 90 degrees) is desired, the length (in the axial direction) of the diamond-shaped units forming the atrial portion 1110 may need to increase. As the axial length of the diamond-shaped units increases in valve frames of different sizes, the length of the beams 1115 may be increased or decreased accordingly. However, in some embodiments, the beams 1115 may be omitted, and the rows of atrial units 1112 may all be "complete" diamond-shaped units.

[0052] Each CAF 1140 may be used as an attachment point to the artificial leaflet 1500, as Figures 9A to 9B , Figures 11A to 11B shown. For example, each CAF 1140 may include a plurality of holes, and sutures may be used to attach adjacent leaflet pairs to the CAF 1140 via the holes in the CAF 1140. Although the CAF 1140 is shown as having four holes and elongated holes in a 2×2 configuration, other specific CAF configurations may be suitable to replace those shown.

[0053] A portion of the frame 1100 in the outflow direction of the turning point 1132 may include a plurality of ventricular units. For example, a first set of ventricular units 1124a may be generally diamond-shaped units whose inflow apex is the turning point 1132. A second set of ventricular units 1124b may extend to the portion of the frame 1100 closest to the outflow end, and the inflow apex of the second ventricular units is connected to the outflow apex of the transition unit 1116. Some, none, or all of the second ventricular units 1124b may include cusp teeth 1126 (which will be described in more detail below), and the cusp teeth 1126 may be used as friction engagement members that frictionally engage with the native tissue to enhance the fixation of the frame 1100 within the native valve annulus. A third set of ventricular units 1124c may be positioned between certain pairs of the second ventricular units 1124b and may include struts that extend from the turning point 1132 to the terminal outflow end of the ventricular portion 1120. The third ventricular units 1124c may be larger than the other ventricular units and may be partially formed by struts of the enlarged transition unit 1117 that terminate at the CAF 1140. With this configuration, at least Figures 8B to 8CIn the cutting pattern shown, the CAF 1140 can be considered to be nested within or form the boundary of the third ventricle unit 1124c.

[0054] None, some, or all of the third ventricle units 1124c can also include the cusp 1126, except that the cusp 1126 is positioned in some, none, or all of the second ventricle units 1124b. Figures 8B to 8C The only difference between the frames shown is the position and configuration of the cusp. In Figure 8B the embodiment shown, each of the third ventricle units 1124c has two cusps 1126, with one cusp 1126 extending upward from each of the two struts closest to the outflow ends that form the unit. On the other hand, in Figure 8C each of the third ventricle units 1124c includes a single cusp 1126 that extends upward from the outflow vertex of the unit. In Figure 8B the embodiment shown, only some of the second ventricle units 1124b include the cusp 1126, such that each second ventricle unit 1124b that includes the cusp 1126 includes a single cusp 1126 that extends upward from one of the outflow struts near the outflow vertex of the unit. On the other hand, in Figure 8C only some of the second ventricle units 1124b include the cusp 1126, such that each second ventricle unit 1124b that includes the cusp 1126 includes a single cusp 1126 that extends upward from the outflow vertex of the unit. All of the cusps 1126 can extend to a free tip with a pointed or blunt point that is intended to pierce tissue or engage the tissue in a frictional manner without piercing it. It should be understood that the number and positioning of the cusps 1126 can be different from that shown in Figures 8B to 8C and the specific number and positioning shown in Figures 8B to 8C are merely exemplary.

[0055] In the illustrated embodiment, the cusp 1126 may be attached at the outflow end of the cusp, with the free tip positioned at the inflow end of the cusp. This orientation of the cusp may allow the valve to deploy more smoothly and easily from the delivery catheter as compared to a cusp attached at its inflow end and having a free tip at its outflow end. In other words, when the valve is released from the delivery catheter and begins to self-expand, the cusp does not begin to expand until the entire cusp is clear of the delivery device. In the opposite orientation, the cusp may begin to radially extend outwardly and contact the end of the delivery sheath, which may make deployment more difficult. However, it should be understood that the orientation of the illustrated cusp may make the loading process slightly more difficult as compared to the opposite orientation. However, smooth and easy deployment is generally more important than smooth and easy loading, and the loading process can be highly controlled and performed outside the patient, while the deployment process is performed inside the patient.

[0056] After forming the frame 1100 by using Figure 8B or Figure 8C the illustrated cut pattern or another generally similar cut pattern, the frame 1100 may be shaped, for example via heat treatment, into the desired shape. Figure 8D An example of the frame 1100 is illustrated which, after having been shaped and having been attached to the commissure support 1600, has a cut pattern similar to that Figures 8B to 8C shown in, which will be described in more detail below.

[0057] As can be seen in Figure 8D , when the frame 1100 is in the expanded or deployed state, the bottom of the atrial portion 1110 may be substantially straight, having a slight upward angle, and the upper half of the atrial portion 1110 may flare upwardly such that the tips of the atrial units 1112 generally point in the inflow direction. The above-described profile may vary from the exact description above while still being suitable for use in the artificial heart valve 1010.

[0058] Still referring to Figure 8D , the ventricular portion 1120 may form a generally "bell-shaped" shape with a more rounded and uneven profile as compared to the atrial portion 1110. The more gradual profile of the ventricular portion 1120 may allow the ventricular portion 1120 to overhang the ventricle and assist in fixing or otherwise positioning the artificial heart valve 1010 onto the native valve annulus with only slight pressure. This slight pressure or overhang may be the first mechanism by which the artificial heart valve 1010 is secured within the native valve annulus.

[0059] The various cusp teeth 1126 described above may be shaped such that the free ends of the cusp teeth 1126 are positioned away from the surface defined by the unit in which the cusp teeth 1126 are located. In other words, the cusp teeth 1126 may be bent or shaped such that the tips can be used to pierce tissue or frictionally engage with tissue without piercing the tissue, to provide a second mechanism by which the artificial heart valve 1010 is fixed within the native valve annulus. The cusp teeth 1126 may be oriented at different angles for different purposes. For example, in some embodiments, some or all of the cusp teeth 1126 may be oriented or angled such that the free ends point towards the atrial portion 1110 at an acute angle relative to the longitudinal axis passing through the center of the artificial heart valve 1010. Compared with a right angle or an obtuse angle, the cusp teeth 1126 pointing at an acute angle are less likely to penetrate the tissue at the native valve annulus. Patients who may require an artificial atrioventricular valve (especially an artificial tricuspid valve) may have very thin inner walls in the ventricles, and the cusp teeth 1126 at an acute angle can particularly reduce the possibility of the inner walls being penetrated by the cusp teeth 1126. Compared with the cusp teeth 1126 having a larger angle (e.g., a right angle or an obtuse angle), the cusp teeth 1126 having an acute angle may have additional benefits related to the loading and deployment of the artificial heart valve 1010. For example, if the cusp teeth 1126 are at a sharper acute angle, the cusp teeth 1126 can provide less resistance when the artificial heart valve 1010 is loaded into a delivery catheter or deployed from the delivery catheter. Less resistance can be equivalent to a more manageable load, which can allow the use of a smaller-sized delivery catheter under the same other conditions. However, this is just one option. Instead, some or all of the cusp teeth 1126 may be shaped to be oriented more laterally relative to the central longitudinal axis of the artificial heart valve 1010 (e.g., a relatively large acute angle, or a right angle or an obtuse angle). Although the cusp teeth 1126 can be entirely optional, if the cusp teeth 1126 are included (whether they are oriented at an acute angle or laterally), the cusp teeth 1126 can provide a second mechanism by which the artificial heart valve 1010 is fixed within the native valve annulus.

[0060] Before describing the support member 1600 in more detail, an exemplary sealing skirt 1200 that can be used with the artificial heart valve 1010 is described. Refer to Figure 8A , the external sealing skirt 1200 can be disposed on the outside of the frame 1100. In some embodiments, the sealing skirt 1200 can be the same as or similar to any of the above embodiments. In Figure 8A the specific example shown, the sealing skirt 1200 can be a single-piece material (although in some embodiments, it can be a multi-piece design), which can be any material described in combination with the above sealing skirt, including for example woven PET. In Figure 8AIn the illustrated embodiment, the sealing skirt 1200 may have an atrial skirt portion 1210 and a ventricular skirt portion 1220. The atrial skirt portion 1210 may be coupled to the atrial portion 1110 of the frame 1100 in a relatively tight connection (e.g., by suturing along the struts of the atrial portion 1110 of the frame 1100). In some embodiments (including Figure 8A the embodiment shown), the inflow edge of the atrial skirt portion 1210 may be positioned at a distance from the atrial tip of the atrial unit 1112. For example, in some embodiments, the atrial end of the frame 1100 is angled toward the atrium ( Figure 8A not shown), and thus the outer sealing skirt 1200 may terminate at a distance from the atrial end such that there is no thrombus-forming profile at the inflow end of the frame 1100. In other embodiments, the inflow edge of the atrial skirt portion 1210 may be positioned to align with or cover the atrial tip of the atrial unit 1112. It should be understood that the various tines 1126 preferably pierce the sealing fabric 1200 such that the free ends of the tines 1126 can be used to frictionally engage native tissue upon implantation.

[0061] Still referring to Figure 8A , the connection of the ventricular skirt portion 1220 to the ventricular portion 1120 of the frame 1100 may be looser than the connection of the atrial skirt portion 1210 to the atrial portion 1110. For example, the outflow edge of the ventricular skirt portion 1220 may be relatively tightly coupled to the outflow end of the ventricular portion 1120 of the frame 1100, but the connection of the sealing skirt 1200 may be relatively loose between the central portion 1130 and the end of the ventricular portion 1120 of the frame 1100. With this configuration, during ventricular contraction (e.g., when the ventricle contracts, the artificial leaflets 1500 close, and the pressure in the ventricle is greater than the pressure in the atrium), the pressure differential causes the ventricular skirt portion 1220 to tumble, inflate, or parachute open. When the ventricular skirt portion 1220 parachutes during ventricular contraction, it may fill any gaps, notches, or openings between the artificial heart valve 1010 and the native valve annulus that could otherwise cause blood leakage around the outside of the artificial heart valve 1010 back into the atrium (i.e., PV leakage).

[0062] Briefly referring to Figure 8D , the illustrated configuration of the frame 1100 may provide a lever effect that may further assist in sealing against PV leakage. For example, when the frame 1100 is in the Figure 8D expanded or deployed state shown, the deformation of the ventricular portion 1120 may tend to push the atrial portion 1110 toward the ventricular portion 1120 in a lever-like manner. Thus, referring back to Figure 8A, when the ventricular skirt portion 1220 inflates or parachutes during ventricular systole, this may cause a slight deformation of the ventricular portion 1120 of the frame 1100, and the atrial portion 1110 of the frame 1100 may be slightly pulled downward against the atrial side of the native valve annulus. This "sandwich" action can further seal to prevent any PV leakage and can also reduce potential embolism. For example, especially in the low-flow environment of the right heart, any gaps or spaces remaining between the artificial heart valve 1010 and the native anatomy may create a thrombus risk area. The above-described lever effect or sandwich effect can reduce or eliminate any such gaps or spaces, thereby reducing the risk of thrombus formation. In a specific example, a patient may have a significant septal bulge, and some patients may especially have a septal bulge across the tricuspid valve annulus in the right ventricle. This anatomy can be an exclusion criterion for transcatheter replacement of the tricuspid valve. However, the above-described sandwich effect or lever effect can allow the artificial heart valve 1010 to be implanted in patients with a relatively significant septal bulge.

[0063] Referring again to Figure 8D , in the deployed or expanded state of the frame 1100, the bottom struts of the enlarged transition unit 1117 to which the CAF 1140 is connected extend in the outflow direction substantially parallel to the central longitudinal axis of the artificial heart valve 1010. With this positioning, the CAF 1140 can be positioned to align or be nearly aligned with the minimum diameter portion of the frame 1100 at the central portion 1130. In other words, the CAF 1140 of the frame 1100 is effectively cantilevered. Such a cantilever of the CAF 1140 may cause certain disadvantages if no additional support is provided. As described above, the artificial leaflets 1500 are coupled to the CAF 1140. Thus, during ventricular systole, when the artificial leaflets 1500 close and apply pressure in the ventricular-to-atrial direction, the CAF 1140 and the struts of the enlarged transition unit 1117 to which the CAF 1140 is attached can deflect radially inward toward each other. Although some amount of deflection may be desirable, the length of the CAF 1140 (which can extend between about 20 - 30 mm from the central portion 1130) may pose a risk of causing excessive deflection. If the CAF 1140 deflects too much during ventricular systole, the artificial leaflets 1500 may not fit properly, resulting in inefficient valve function. Additionally, another disadvantage of a large deflection of the CAF 1140 is that the struts from which the CAF 1140 extends may fatigue quickly, potentially leading to failure of the frame 1100.

[0064] If the CAF 1140 of the frame 1100 does not have additional support, other potential disadvantages may result. For example, Figure 9AIllustrated is an artificial heart valve 1010 deployed from a delivery device DD, with the ventricular portion 1120 and the ventricular skirt portion 1220 having begun to self-expand. When the atrial portion 1110 remains within the delivery device DD, a lever-type effect can cause the CAF 1140 to tend to expand radially outward when the artificial heart valve 1010 begins to deploy. If the CAF 1140 is not supported separately, the CAF 1140 may tend to expand to a radially outward position from its shaped position. As a result of such expansion, the artificial leaflets 1500 can be pulled or stretched, which can be seen in the Figure 9A view. Even if such expansion occurs temporarily during delivery, the artificial leaflets 1500 (and / or the sutures connecting the artificial leaflets 1500 to the CAF 1140) may be damaged, stressed, or otherwise weakened enough to pose a risk that the artificial leaflets 1500 may not function properly at implantation, or that even if the artificial leaflets 1500 function properly at implantation, the lifespan of the artificial leaflets 1500 may be reduced due to the stress during CAF 1140 expansion.

[0065] If the CAF 1140 of the frame 1100 does not have additional support, it can lead to a third potential drawback. Figure 9B Illustrated is the ventricular side of the artificial heart valve 1010, which lacks a CAF support member. In Figure 9B , pressure is manually applied to the ventricular portion 1120 in a manner generally simulating the pressure that will be generated during ventricular systole (note that during actual ventricular systole, the artificial leaflets 1500 will close, which is not shown in Figure 9B ). Since the CAF 1140 is connected to the ventricular portion 1120 of the frame 1100, deformation of the ventricular portion 1120 of the frame can cause deformation of the CAF 1140, and in particular, deformation of their relative positions with respect to each other. As can be seen in Figure 9B , when the ventricular portion 1120 of the frame 1100 is manually deformed, the CAF 1140 deforms and deviates from their generally circular or cylindrical alignment. This can be undesirable because when the CAF 1140 deforms away from their shaped (generally circular or cylindrical alignment), it becomes less likely that the artificial leaflets 1500 will fit properly with each other to form a seal.

[0066] To address any one or more of the potential drawbacks of the CAF 1140 that do not include an additional support member, a commissure support member 1600 (which may be referred to herein as a CAF support or simply a support member) can be provided. In Figure 8DIn [the figure], the CAF support member 1600 is shown as being assembled to the frame 1100. The CAF support member 1600 can take various forms, but in some examples, it can be an expandable and collapsible annular structure. Figure 10A A cutting pattern for one example of the CAF support member 1600 is shown. In Figure 10A the embodiment, the CAF support member 1600 is formed of a shape memory material (such as Nitinol) and can be laser cut from a Nitinol tube using a pattern similar to that Figure 10A shown in [the figure]. Figure 10A The cutting pattern shown in [the figure] is a single row of diamond-shaped cells 1610. In other words, after using the Figure 10A cutting pattern on the Nitinol tube, the resulting structure can be shaped (e.g., via heat treatment) such that, without the application of force, the CAF support member 1600 forms an overall circular or cylindrical ring having a single row of diamond-shaped cells 1610. In the expanded or unbiased state, the inner diameter of the CAF support member 1600 is approximately equal to the diameter of the circle that aligns with the outer surface of the CAF 1140 when the frame 1100 is in its expanded or unbiased state.

[0067] The CAF support member 1600 can be positioned on the exterior of the CAF 1140 (and / or the unit struts from which the CAF 1140 extends) and coupled to the frame 1100 via any suitable mechanism. For example, in some embodiments, the CAF support member 1600 can simply be sutured to the CAF 1140 and / or the unit struts from which the CAF 1140 extends. In other embodiments, the CAF support member 1600, the CAF 1140 (or its associated struts), or both can include features to assist with fixation. For example, returning to reference Figure 8C , one or both of the two struts leading to the CAF 1140 can include one or more holes 1142 that can be used to assist in suturing the CAF support member 1600 (e.g., at the intersections where two adjacent diamond-shaped cells 1610 meet) to the frame 1100. In Figures 8B to 8C the frame 1100 shown, each strut leading to the CAF 1140 includes a single hole at the same axial location. However, in Figure 8DIn the example shown, each strut leading to each CAF 1140 includes two holes, and the holes on one strut may or may not be axially aligned with the holes on the other strut of the pair of struts. It should be understood that the number, shape, and positioning of the holes 1142 may be different from those shown in the drawings while still providing the desired functionality. And although stitching is described as a mechanism for fastening the CAF support 1600 to the frame 1100, it should be understood that other methods (such as adhesives, rivets (or other mechanical fasteners), etc.) may similarly be suitable. Although the CAF support 1600 is shown and described as being positioned outside the CAF 1140, in some examples, the CAF support 1600 may be positioned inside the CAF 1140.

[0068] Figure 10B A cutting pattern for the CAF support 1600’ is shown, which is slightly different from Figure 10A the cutting pattern of. Except that the CAF support 1600 includes a single row of diamond-shaped units 1610, while the CAF support 1600’ includes two rows of diamond-shaped units 1610’, 1620’, the CAF support 1600’ may be similar or identical to the CAF support 1600. It should be understood that changing the parameters of the CAF supports 1600, 1600’ (such as the size of the units 1610, 1610’, 1620’, the wall thickness of the CAF support, the width of the struts forming these units, and / or the number of rows of units in the CAF support) may affect the performance of the CAF support. In other words, by changing these parameters, the size and foldability of the CAF support can be partially fine-tuned, and similarly, by changing these parameters, the actual amount of support provided by the CAF support to the CAF 1140 (which can determine the amount of anti-expansion, deformation, and / or deflection of the CAF 1140) can be partially fine-tuned.

[0069] Although the CAF supports 1600, 1600’ are shown as not having any special features for assisting in fixing the CAF support to the frame 1100, it should be understood that such features may be provided on the CAF supports 1600, 1600’. For example, holes may be provided in the struts forming the CAF supports 1600, 1600’ (such as at the intersection of two adjacent diamond-shaped units) to facilitate fastening (such as stitching or riveting) the CAF supports 1600, 1600’ to the frame 1100, regardless of whether the frame 1100 itself includes similar (e.g., complementary shape, size, or positioning) connection features.

[0070] In some embodiments, the CAF support may be configured to be directly coupled to the CAF 1140, rather than being coupled to the unit struts leading to the CAF 1140 or in addition to being coupled to the unit struts leading to the CAF 1140 and also being coupled to the CAF 1140. For example, Figure 10C shows a cutting pattern for the CAF support 1600”, which is slightly different from Figures 10A to 10B the cutting pattern of. The CAF support 1600” may be similar or identical to the CAF support 1600’, with the main exception being that the CAF support 1600” includes an integrated connector 1640”, which is configured to facilitate direct coupling of the CAF support 1600” to the CAF 1140. For example, in Figure 10C the illustrated embodiment, the second row of cells 1620” includes a connector 1640” formed at the intersection of two adjacent diamond-shaped cells 1620”, where the connector 1640” has a configuration of 2×2 holes, which has the same configuration as the 2×2 hole group in the CAF 1140. With this configuration, the CAF support 1600’ can be attached to the frame 1100 via a “top-cover” technique, where the connector 1640” is laid on the corresponding-shaped portion of the CAF 1140, and the four holes are directly stitched (or otherwise joined or mechanically fastened) to the corresponding portion of the CAF 1140. To help illustrate the complementary structures, Figure 10D illustrates the cutting pattern of the CAF support 1600” top-covered on the cutting pattern of the frame 1100. However, it should be understood that the CAF support 1600” is typically attached after the frame 1100 has been expanded, and the CAF support 1600” surrounds the CAF 1140 (and the struts attached to the CAF 1140), but not the ventricular cells. It should be understood that although Figure 10C“A connector 1640 is shown, but a total of three connectors 1640 will be provided to correspond to the three CAFs 1140 of the frame 1100. If the frame 1100 includes more or fewer than three CAFs 1140, a similar number of connectors 1640 can be provided correspondingly on the CAF support 1600”. Also, although the connector 1640 is shown as having a configuration of 2×2 holes, other configurations can also be provided. For example, if the CAF 1140 includes a configuration of holes different from those shown in the figure, the connector 1640 can be correspondingly provided with a different configuration of holes. And in some embodiments, the connector 1640 and the CAF 1140 do not need to include an exact configuration of exactly the same holes, although this one-to-one correspondence can simplify the coupling process. For example, even if the CAF 1140 includes a configuration of 2×2 holes (with or without additional elongated holes), the connector 1640 can include a group of 2×1 or 1×2 holes. One of the benefits of the configuration of the support ring 1600 is that it can simplify the process of coupling the support ring 1600 to the frame 1100, and once coupled to the connector 1640 and the above covering method is aligned with the CAF 1140, the support ring 1600 is more likely to fold and expand uniformly and consistently during being loaded into the conveying device and / or being deployed from the conveying device.

[0071] The seam support members shown and described above have been described as shaped or otherwise configured to be generally circular or cylindrical in shape, which will generally match the shape of the perimeter of the CAF 1140 when the artificial heart valve 1010 expands and / or is deployed. However, in some cases, the artificial leaflet 1500 can open (e.g., during atrial systole) to a range in which the artificial leaflet 1500 tends to extend radially outward from the circular perimeter formed along the CAF 1140. In other words, if the seam support 1600 (or seam support 1600' or 1600") is formed as a circle and coupled to the outer surface of the CAF 1140, when the artificial leaflet 1500 opens, the artificial leaflet 1500 may have a risk of contacting the inner surface of the seam support. This type of contact is generally not desired. To alleviate this concern, any of the above seam supports or any similar suitable design can be shaped to provide a clearance for the artificial leaflet 1500 when they open. For example, Figure 10E A schematic diagram of a seam support 1600 in its expanded state with multiple leaflets is shown (although this can be applied to other seam supports described herein). For example, in a given example, the artificial heart valve includes three artificial leaflets 1500, and thus the seam support 1600 is formed (e.g., via shape setting) to have three leaflets. Figure 10EIt is shown that the outer diameter of the frame 1100 at the position of the outer surface of the CAF 1140 of the frame 1100 has a value D1. In one example, this outer diameter D1 at the CAF can be about 30 mm. Since the leaflets 1500 are coupled to the CAF 1140, the leaflets 1500 at these positions do not change position (or at least do not change significantly) during the opening and closing of the artificial leaflets 1500. Thus, at these positions, the commissure support 1600 has a minimum extent 1650 that contacts the outer surface of the CAF 1140. However, when the artificial leaflets 1500 are open, the middle of the free edge is typically the part that can have the greatest outward movement. To account for the possible large movement, the commissure support 1600 increases in radial extent from the longitudinal center of the artificial heart valve 1010 to a maximum extent 1660, which is approximately positioned midway along the perimeter of the commissure support 1600 between two adjacent minimum extents 1650. At this maximum extent 1660, the distance between the outer surface of the frame 1100 and the commissure support 1600 can have a length L1. Although the length L1 can be adjusted as desired, in one example, the length L1 is about 1.5 mm. In other words, the middle of the free edge of the artificial leaflets 1500 can elongate by up to about 1.5 mm beyond the diameter D1 without being interfered with by the commissure support 1600. In an artificial heart valve 1010 having three leaflets 1500, Figure 10E the commissure support 1600 shown therein will have three minimum extents 1650 positioned at approximately 120-degree intervals (aligned with the CAF 1140), and three maximum extents 1660 positioned at approximately 120-degree intervals (generally aligned with the middle of the free edge of the artificial leaflets 1500), where the maximum extents 1660 are offset from the minimum extents 1650 by about 60 degrees. The specific shape of the transition between the minimum extent 1650 and the maximum extent 1660 can vary, but is preferably formed to resemble Figure 10E the leaflet shape shown therein to provide a substantial amount of additional space for the movement of the artificial leaflets 1500.

[0072] It should be understood that the above-described additional clearance (e.g., additional length L1) is not always necessary, and the specific design of the artificial leaflets 1500 can affect whether the use of a circular commissure support 1600 will cause any interference. It should also be understood that the leaflet design of the commissure support 1600 can still provide some or all of the benefits described above in connection with the circular design of the commissure support 1600, including mitigation of expansion, deformation, and / or excessive deflection of the CAF 1140.

[0073] Figure 11A An artificial heart valve 1010 is shown prior to applying manual compression to the ventricular portion 1120 of the frame 1100, which includes a commissure support 1600. InFigure 11A in which the buttress support 1600 is shaped as a circle, rather than Figure 10E a leaflet configuration. Under Figure 11A the conditions, both the buttress ring 1600 and the ventricular portion 1120 maintain a highly circular profile. However, Figure 11B illustrates the changes after manual compression is applied to the ventricular portion 1120 of the frame 1100. As can be seen in Figure 11B , the ventricular portion 1120 of the frame 1100 undergoes a significant amount of elliptization. In other words, after manual compression, the ventricular portion 1120 of the frame 1100 becomes elliptical in profile, with a large difference between the major axis and the minor axis of the elliptical profile. Although the ventricular portion 1120 of the frame 1100 becomes significantly elliptical, the buttress support 1600 (and thus the CAF 1140) maintains an almost perfect circular profile. It should be understood that although the buttress support 1600 in Figure 11B may be slightly elliptized, but Figure 11B the force applied in

[0074] Figure 12 is greater than the force expected when the artificial heart valve 1010 is used as an artificial tricuspid valve, where a large amount of force is applied to illustrate the significant difference in shape between the ventricular portion 1120 of the frame 1100 and the buttress support 1600. When actually used in an artificial heart valve (e.g., an artificial tricuspid valve), it can be expected that the buttress support 1600 maintains an almost perfect circular profile to maintain the optimal fit of the artificial leaflets 1500. Figure 12 shows the artificial heart valve 1010 (the "soft" structures such as the artificial leaflets 1500 and the sealing skirt 1200 have been removed for clarity) after it has been implanted into an artificial heart valve that has previously been treated with the leaflet repair clip 2000. It should be understood that TM (MitraClip TM ) device or a tricuspid valve clip TM (TriClip TM)A valve repair device that clamps two mitral valve leaflets or tricuspid valve leaflets together, respectively. If the leaflet repair clip 2000 device was previously implanted at an acceptable distance (e.g., similar to the relative position of the leaflet repair clip 2000 and the artificial heart valve 1010 shown in Figure 12 ) close to the native leaflet commissure, then even though the leaflet repair clip 2000 causes an obstruction, the sealing skirt 1200 can seal to prevent PV leakage. And if the cells of the frame 1100 at the ventricular portion 1120 are large (e.g., cells 1124b, 1124c), the previously implanted leaflet repair clip 2000 may not exert any substantial pressure on the annulus due to the action of the artificial heart valve 1010, because the leaflet repair clip 2000 may fall into the open area of one of these large cells.

[0075] It can be understood from the disclosure provided herein that in some embodiments, the artificial heart valve includes a single frame (e.g., a nitinol frame) having a commissure support member to facilitate a wide annular anatomical treatment range of the artificial heart valve while having a minimum profile. The frame design and / or the commissure support member helps to minimize the pressure exerted by the artificial heart valve on the native valve annulus. The single-layer frame helps to enable the artificial heart valve to be compressed into a catheter having a small diameter (e.g., <33 French or <30 French), where the seal is partially achieved by a sealing fabric spanning the gap between the atrial and ventricular disks of the frame. The commissure support can help ensure the long-term durability of the artificial leaflets and the ventricular portion of the frame. And although the disclosure provided herein can be applied to artificial heart valves for replacing mitral valves or tricuspid valves, due to the lower ventricular pressures involved, these features can work particularly well with tricuspid valves, which can reduce the need for a more cumbersome two-piece frame design. Additionally, the native tricuspid valve does not have the more prominent fibrous structure found in the native mitral valve. Thus, the artificial heart valve described herein does not utilize the native structure around the valve annulus (as is typically done with artificial mitral valves) (utilizing the native structure around the valve annulus can handle the compression used by other artificial heart valves well), but can be anchored within the tricuspid valve annulus via one or more of the following: (i) slight pressure or overhang of the generally bell-shaped ventricular portion 1120 of the frame; (ii) providing ventricular cusp teeth 1126 that frictionally engage the native valve annulus; and / or (iii) assisted fixation using the parachuting of the sealing skirt 1200.

[0076] It should be understood that although the artificial heart valve 1010 is described as including the frame 1100 and a separate commissure support 1600, including the commissure support 1600 does not significantly increase the profile of the artificial heart valve 1010 in the folded state compared to more traditional two-frame valves that can be used in mitral valve prostheses.

[0077] In an exemplary use of the artificial heart valve described herein, the artificial heart valve can begin in an expanded state before implantation into a patient. As described above, the artificial heart valve can include a single monolithic or integral stent having an outer fabric on the stent, where a commissure support member (circular or leaflet-shaped) surrounds commissure attachment features. The artificial heart valve can be pulled or otherwise forced into a delivery catheter, and the artificial heart valve transitions to a folded state as it moves into the delivery catheter. Preferably, the outer diameter of the catheter of the delivery device is sized 30 French (10 mm) or less, including 28 French (9.33 mm) or less or 24 French (8 mm) or less. In the case where the artificial heart valve is successfully folded into the small-diameter delivery device catheter, the delivery device can be introduced into the patient (e.g., via the femoral vein) and navigated to the target site (e.g., the native tricuspid valve). Upon reaching the target site, the artificial heart valve can be deployed from the delivery device catheter, e.g., by retracting the delivery device catheter relative to the artificial heart valve. When the restraint on the artificial heart valve is removed, the artificial heart valve will naturally begin to expand as the stent tends to return to its pre-set shape. Preferably, the ventricular disk of the artificial heart valve is first released within the ventricle (e.g., the right ventricle). As the ventricular disk expands, the ventricular disk can begin to exert a slight pressure on the tissue, and the ventricular tines can frictionally engage (pierce or not pierce the native tissue) with the native tissue. If another device (e.g., a tricuspid valve leaflet repair clip) has been previously implanted, the artificial heart valve is preferably oriented such that some, most, or all of the leaflet repair clip is oriented to align with the opening portion of the unit on the ventricular side of the frame. As deployment continues, the central portion of the stent of the artificial heart valve will generally align with the valve annulus. As the atrial side of the artificial heart valve deploys, the atrial disk of the stent will expand on the atrial side of the native valve. Thus, as described above, a small delivery device can be used despite the need to cover a large native valve annulus area, and no sealing ability is lost despite using only a single stent with a very small central portion for accommodating the artificial leaflets.

[0078] Figure 13A Shows a cut pattern of an alternative frame 2100 that is almost identical to Figure 8C the frame 1100, with the main exception being the structure of the CAF 2140. Although compared to Figure 8CCompared with the frame 1100, the frame 2100 may also include some other minor differences (such as the number and positioning of the ventricular apices, and the exact shape of certain units), but for the sake of brevity, only the CAF 2140 of the frame 2100 will be described in more detail below. Otherwise, the frame 2100 may be similar to or identical to the frame 1100, and the description of the frame 1100 may otherwise apply to the frame 2100.

[0079] Figure 13B An enlarged view of one of the CAFs 1240 is shown. Like the CAF 1140, the CAF 1240 may be coupled to two struts at the outflow end of the enlarged transition unit 2117. Additionally, like the CAF 1140, the CAF 1240 may be considered to form the boundary of or be nested within the ventricular unit 2124c. Each CAF 1240 may generally be in the shape of a beam and may include a single row of eyelets 2141a, where the row of eyelets 2141a includes two eyelets 2141b in a horizontal or circumferential row, and the two eyelets 2141b are located on the sides of opposite ends of the row of eyelets 2141a. Thus, the CAF 2140 may have a generally "dog bone" shape. The row of eyelets 2141a may provide multiple options for stably attaching the commissure of the prosthetic leaflets to the CAF 2140, and the general shape of the CAF 1240 will not shorten as the frame 2100 expands as might occur with a diamond-shaped feature. The horizontally paired eyelets 2141b may help provide additional stability to the commissure tissue sutured through the eyelets 2141b in the axial or flow direction of the prosthetic heart valve.

[0080] Figure 13C Illustrated is a cut pattern of an alternative version of the commissure support 2600. The commissure support 2600 may generally be similar to those described above, and the descriptions of other embodiments (including the alternatives described therewith) may generally apply to the commissure support 2600. In the illustrated embodiment, the commissure support 2600 includes a first row of units 2610 and a second row of units 2620, and an integrated connector 2640 disposed on the commissure support 2600. The main difference between the commissure support 1600" and the commissure support 2600 is the shape of the connector 2640, which is shaped to be complementary to the shape of the CAF 2140. As Figure 13DAs shown in the enlarged view, the connector 2640 can have a partial "dog bone" shape that includes a central eyelet 2641a and two horizontally paired eyelets 2641b arranged adjacent to the central eyelet 2641a. In this particular embodiment, the three eyelets of the connector 2640 can provide a three-point connection to the corresponding CAF 2140. In particular, the two horizontally arranged eyelets 2641b can be aligned with any pair of the eyelets 2141b, where the central eyelet 2641a is aligned with the eyelet 2141a in the row of eyelets of the CAF 2140, and the eyelet 2141a is positioned adjacent to the associated pair of horizontal eyelets 2141b.

[0081] The symmetry of the eyelets in the CAF 2140 can allow the seam support 2600 to be coupled to the frame 2100 in two different orientations. For example, Figure 13E illustrates the seam support 2600 overlying the frame 2100, where the connector 2640 is aligned with the inflow side of the CAF 2140, while Figure 13F illustrates the opposite orientation, in which the connector 2640 is aligned with the outflow side of the CAF 2140. In either of these two orientations, the seam support 2600 can generally overlie the same portion of the frame 2100. In other words, either orientation of the seam support 2600 can be used relative to the frame 2100 without any significant deviation in the resulting functionality, but different options may be desirable for assembly. As explained in connection with Figure 10D what has been explained, Figures 13E to 13F the views are only intended to illustrate how the seam support 2600 can overlie the CAF 2140, and in the actual assembled and expanded state, the seam support 2600 will only surround the CAF 2140 and not the rest of the ventricular unit of the frame.

[0082] The above points are shown in Figures 13G to 13H which shows the frame 2100 and the seam support 2600 in the assembled and expanded state, with other components of the artificial heart valve omitted from the view. In the view of Figure 13G the atrial (or inflow) portion 2110 (which can include pins 2114) is positioned towards the bottom of the view, and the ventricular (or outflow) portion 2120 (which can include cusp teeth 2126) is positioned towards the top of the view. The seam ring 2600 is radially positioned inside the ventricular portion 2120 rather than the CAF 2140, where the CAF 2140 is positioned inside the seam ring 2600. As can be seen in Figure 13G and especially in Figure 13H the enlarged view of Figure 13EThe first orientation match shown in. Although not shown in Figures 13G to 13H a buffer material may be provided between the contact points of the seam ring 2600 and the frame 2100 such that there is no or minimal direct metal-to-metal contact. Any buffer material may be suitable, including fabric materials or tissue materials, and similar buffer materials may be provided with other embodiments described herein to prevent or minimize metal-to-metal contact between the frame and the seam support.

[0083] In some examples, a method of manufacturing an artificial heart valve for replacing a native atrioventricular valve includes forming a collapsible and expandable frame from a tube of shape memory material. The method may include shaping the collapsible and expandable frame such that, without the application of force, the collapsible and expandable frame has an atrial disk, a ventricular disk, and a central portion extending between the atrial disk and the ventricular disk, the frame including a plurality of seam attachment features that include struts extending from the central portion of the frame. A plurality of artificial leaflets may be mounted to the plurality of seam attachment features. A sealing fabric may be attached to the outer surface of the collapsible and expandable frame. After shaping the collapsible and expandable frame, a seam support ring may be attached to the plurality of seam attachment features to support the plurality of seam features. The seam support ring may be formed from a tube of shape memory material. The seam support ring may be shaped to have an annular or leaflet shape without the application of force. After shaping the collapsible and expandable frame and after shaping the seam support ring, without the application of force, each of the atrial disk and the ventricular disk may flare outward from the central portion of the frame, the central portion of the frame may define a minimum diameter of the frame, and each of the plurality of seam attachment features may be spaced apart from an adjacent seam attachment feature of the plurality of seam attachment features such that gaps exist in the frame between adjacent seam attachment features of the plurality of seam attachment features.

[0084] While the invention has been described with respect to specific embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the invention. Thus, it is to be understood that numerous modifications may be made to the exemplary embodiments and other arrangements may be devised without departing from the spirit and scope of the invention as defined by the appended claims.

Claims

1. An artificial heart valve for replacing a native atrioventricular valve, the artificial heart valve comprising: A collapsible and expandable frame, the frame including an atrial disk, a ventricular disk, and a central portion extending between the atrial disk and the ventricular disk, the frame including a plurality of commissural attachment features, the plurality of commissural attachment features including struts extending from the central portion of the frame; A plurality of artificial leaflets, the plurality of artificial leaflets being mounted to the plurality of commissural attachment features; A sealing fabric, the sealing fabric being coupled to an outer surface of the frame; And A commissural support ring, the commissural support ring being coupled to the plurality of commissural attachment features and extending around the plurality of commissural attachment features, Wherein in the expanded state of the artificial heart valve, each of the atrial disk and the ventricular disk flares outwardly from the central portion of the frame, the central portion of the frame defining a minimum diameter of the frame, and each of the plurality of commissural attachment features is spaced apart from an adjacent commissural attachment feature of the plurality of commissural attachment features such that a gap exists in the frame between adjacent commissural attachment features of the plurality of commissural attachment features.

2. The artificial heart valve according to claim 1, wherein the commissural support ring is a collapsible and expandable structure, the collapsible and expandable structure having a circular shape in the expanded state of the commissural support ring.

3. The artificial heart valve according to claim 1, wherein the commissural support ring is a collapsible and expandable structure, the collapsible and expandable structure having a leaflet-shaped shape in the expanded state of the commissural support ring.

4. The artificial heart valve according to claim 3, wherein in the expanded state of the commissural support ring, a first portion of the commissural support ring aligned with the plurality of commissural attachment features has a minimum diameter of the commissural support ring, and a second portion of the commissural support ring aligned with an intermediate portion of the free edges of the plurality of artificial leaflets has a maximum diameter of the commissural support ring.

5. The artificial heart valve according to claim 1, wherein the commissural support ring includes a first circumferential row of generally diamond-shaped units.

6. The artificial heart valve according to claim 5, wherein the commissural support ring includes a second circumferential row of generally diamond-shaped units, the second circumferential row being adjacent to the first circumferential row.

7. The artificial heart valve according to claim 6, wherein the commissural support ring includes a plurality of connectors integrally formed with the commissural support ring, each of the plurality of connectors having a shape complementary to the shape of each commissural attachment feature of the plurality of commissural attachment features.

8. The artificial heart valve according to claim 1, wherein the frame includes a plurality of cusp teeth on the ventricular disk, each of the plurality of cusp teeth extending to a free end pointing towards the atrial disk in the folded state of the frame.

9. The artificial heart valve according to claim 8, wherein in the expanded state of the artificial heart valve, at least some of the plurality of cusp teeth extend at an acute angle with respect to the central longitudinal axis of the artificial heart valve.

10. The artificial heart valve according to claim 8, wherein in the expanded state of the artificial heart valve, at least some of the plurality of cusp teeth extend at an obtuse angle with respect to the central longitudinal axis of the artificial heart valve.

11. The artificial heart valve according to claim 1, wherein the struts extending from the central portion of the frame include at least one hole.

12. The artificial heart valve according to claim 11, wherein the commissure support ring is coupled to the plurality of commissure attachment features via mechanical fasteners extending through the at least one hole.

13. The artificial heart valve according to claim 1, wherein in the expanded state of the artificial heart valve, the ventricular disk of the frame is bell-shaped.

14. The artificial heart valve according to claim 13, wherein the sealing fabric extends above the ventricular disk and above the central portion of the frame, and the inflow edge of the sealing fabric is positioned at a distance from the end of the atrial disk.

15. The artificial heart valve according to claim 13, wherein in the implanted state of the artificial heart valve, at least a portion of the sealing fabric is configured to parachute during ventricular systole to contact the structure of the native atrioventricular valve.

16. The artificial heart valve according to claim 1, wherein the plurality of commissure attachment features extend from the central portion of the frame in the outflow direction, and the commissure support ring is positioned relative to the central portion of the frame in the outflow direction.

17. A method of implanting an artificial heart valve, the method comprising: loading the artificial heart valve into a delivery device, the artificial heart valve including a collapsible and expandable frame having an atrial disk, a ventricular disk, a central portion extending between the atrial disk and the ventricular disk, a plurality of commissure attachment features including struts extending from the central portion of the frame, and a plurality of artificial leaflets mounted to the plurality of commissure attachment features; advancing the delivery device to the native heart valve of a patient while maintaining the artificial heart valve in a collapsed state by the delivery device; when the delivery device is positioned in or adjacent to the native heart valve, beginning to deploy the artificial heart valve in the ventricle of the patient such that the ventricular disk begins to expand and such that a sealing fabric coupled to the outer surface of the frame moves toward the native heart valve; and continuing to deploy the artificial heart valve such that the central portion is positioned against the annulus of the native heart valve and the atrial disk expands within the atrium of the patient, wherein when beginning to deploy the artificial heart valve, a commissure support ring coupled to and extending around the plurality of commissure attachment features limits the distance that the plurality of commissure attachment features can expand outward.

18. The method according to claim 17, wherein at least one of the plurality of cusp teeth on the ventricular disc frictionally engages the tissue of the native heart valve when starting to deploy the artificial heart valve.

19. The method according to claim 17, wherein the commissure support ring is a foldable and expandable structure, and when the artificial heart valve is fully deployed within the native heart valve, the foldable and expandable structure has a circular shape.

20. The method according to claim 17, wherein the commissure support ring is a foldable and expandable structure, and when the artificial heart valve is fully deployed within the native heart valve, the foldable and expandable structure has a leaflet shape.

21. The method according to claim 20, wherein when the artificial heart valve is fully deployed within the native heart valve, a first portion of the commissure support ring aligned with the plurality of commissure attachment features has the minimum diameter of the commissure support ring, and a second portion of the commissure support ring aligned with the middle portion of the free edges of the plurality of artificial leaflets has the maximum diameter of the commissure support ring, such that when the plurality of artificial leaflets open during atrial systole, the middle portion of the free edges of the plurality of artificial leaflets reaches a position radially outward of the first portion of the commissure support ring and radially inward of the second portion of the commissure support ring.

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