Connecting skirt for attaching valve leaflets to the frame of an artificial heart valve

Abstract

Methods and assemblies are disclosed for attaching leaflets to a frame of a prosthetic heart valve using a connecting skirt. As an example, the prosthetic heart valve may include an annular frame with a plurality of struts and a valve leaflet structure mounted within the frame and comprising a plurality of leaflets. A leaflet portion of each leaflet may be connected to the frame by a connecting skirt, where each connecting skirt includes a central portion and opposing side base portions on opposing sides of the central portion connected to and disposed between each of the frame and the leaflet leaflet portion, and each connecting skirt may further include a side extension portion extending outwardly from the leaflet leaflet portion and across the struts of the frame disposed between the leaflet leaflet portions of two adjacent leaflets.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 139,514, filed on January 20, 2021, which is incorporated herein by reference in its entirety.

[0002] The present disclosure relates to an artificial heart valve and a method and assembly for attaching valve leaflets to a frame of an artificial heart valve having one or more connecting skirts.

Background Art

[0003] The human heart can suffer from various valve diseases. These valve diseases can lead to significant heart dysfunction and may ultimately require repair of the native valve or replacement of the native valve with an artificial valve. There are many known repair devices (e.g., stents) and artificial valves, as well as many known methods for implanting these devices and valves into humans. Percutaneous and minimally invasive surgical techniques are used in various procedures to deliver artificial medical devices to locations within the body that are not easily accessible by surgery or where surgery - free access is desired. In one specific example, an artificial heart valve can be attached in a crimped state on the distal end of a delivery device and advanced through the patient's vasculature (e.g., through the femoral artery and aorta) until the artificial valve reaches the implantation site within the heart. Thereafter, the artificial valve is expanded to its functional size, for example, by inflating a balloon on which the artificial valve is mounted and actuating a mechanical actuator that applies an expanding force to the artificial valve, or by deploying the artificial valve from the sheath of the delivery device so that the artificial valve can self - expand to its functional size.

[0004] In some embodiments, the artificial heart valve may include a radially expandable and compressible frame containing multiple struts and valve structures within and attached to the frame. The valve structures may include multiple leaflets. In some embodiments, the pointed portion of each leaflet may be secured to the frame by a connecting skirt attached to the leaflet. In such arrangements, the struts of the frame positioned between adjacent leaflet pointed portions may not be covered by the leaflet and connecting skirt material.

[0005] When the artificial heart valve is radially compressed on and around the inflatable balloon of the delivery device, uncovered struts, which may include apex at the inlet end of the frame, may come into direct contact with the balloon. As a result, the uncovered struts and apex may cause wear or deterioration of the balloon. In some embodiments, this may result in reduced or insufficient inflation of the balloon when attempting to deploy the artificial heart valve to the implantation site using the delivery device.

[0006] Therefore, there is a need for improved artificial heart valves and methods for assembling valve structures to the frame of the artificial heart valve, which can result in reduced contact between the frame supports and the balloon of the delivery device when the artificial heart valve is radially compressed on the delivery device around the balloon. [Overview of the project] [Means for solving the problem]

[0007] This specification describes examples of artificial heart valves including a frame and a valve assembly disposed within and attached to the frame, and methods for assembling an artificial heart valve including a leaflet assembly. In some embodiments, the valve assembly may comprise a plurality of leaflets, each leaflet comprising opposing tabs on opposing sides of the leaflet and a apical portion between the tabs. For each leaflet, the apical portion may be connected to the frame by a connecting skirt. The connecting skirt may include a central portion, opposing side base portions on opposing sides of the central portion, and side extensions extending outward from each side base portion. The central portion and opposing side base portions of the connecting skirt may be connected to each of the frames, and the apical portions and side extensions of the leaflets may extend across a frame strut positioned between the apical portions of two adjacent leaflets.

[0008] In one typical embodiment, the artificial heart valve comprises an annular frame that is radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration, having an inlet end and an outlet end, the frame comprising a plurality of struts. The artificial heart valve further comprises a valve structure mounted within the frame and comprising a plurality of leaflets, each leaflet comprising opposing tabs on opposing sides of the leaflet and a pointed portion between the tabs. Each pointed portion of the leaflet is connected to the frame by a connecting skirt, each connecting skirt comprising a central portion and opposing side base portions on opposing sides of the central portion, connected to and positioned between the frame and the pointed portions of the leaflets, each connecting skirt further comprising a side extension portion extending outward from the pointed portion of the leaflet and across struts of the frame positioned between adjacent leaflet pointed portions.

[0009] In another representative embodiment, the artificial heart valve comprises an annular frame having an inlet end and an outlet end, which is radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration, the frame comprising a plurality of struts. The artificial heart valve further comprises a valve structure mounted within the frame and comprising a plurality of leaflets, each leaflet comprising opposing tabs on opposing sides of the leaflet and a pointed portion between the tabs, each tab pairing with an adjacent tab of an adjacent leaflet to form a plurality of commissae connected to the frame. The artificial heart valve further comprises a plurality of connecting skirts, each connecting skirt comprising a lateral base portion and a central portion connected to each of the pointed portions of corresponding leaflets of the plurality of leaflets and to struts of the frame, each connecting skirt further comprising a lateral extension portion extending outward from the pointed portion, each lateral extension portion of each connecting skirt extending across struts of the frame between the pointed portions of adjacent leaflets and connecting to an adjacent lateral extension portion of an adjacent connecting skirt.

[0010] In another typical example, a method for assembling an artificial heart valve comprising multiple leaflets includes forming multiple leaflet assemblies with multiple leaflets. Each leaflet assembly is formed by fastening a central portion and a lateral base portion of a connecting skirt to the pointed edge portion of a leaflet, and each connecting skirt includes two lateral portions, one on each side of the central portion, and each lateral portion includes a corresponding lateral base portion of the lateral base portion and a lateral extension portion extending outward from the corresponding lateral base portion. The method further includes fastening each connecting skirt to a frame of an artificial heart valve, wherein the frame comprises a plurality of interconnected angled struts, and the fastening includes fastening the central portion and the lateral base portion of the connecting skirt to a first strut of the plurality of struts, and extending each lateral extension portion of the connecting skirt over a second strut of the plurality of struts positioned between the pointed edge portions of adjacent leaflets, and fastening each lateral extension portion to an adjacent lateral extension portion of an adjacent connecting skirt.

[0011] In another representative embodiment, the artificial heart valve comprises an annular frame having an inlet end and an outlet end, which is radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration, the frame comprising a plurality of struts. The artificial heart valve further comprises a valve structure mounted within the frame and comprising a plurality of leaflets, each leaflet comprising opposing tabs on opposing sides of the leaflet and a pointed portion between the tabs, each tab pairing with an adjacent tab of an adjacent leaflet to form a plurality of commissations connected to the frame. The artificial heart valve further comprises a plurality of connecting skirts, each connecting skirt comprising a base portion connected to each of the pointed portions of corresponding leaflets of the plurality of leaflets and to the struts of the frame, each connecting skirt further comprising an extension portion extending outward from the pointed portion and covering the inner surface of the struts of the frame positioned between the pointed portions of adjacent leaflets. The artificial heart valve further comprises an outer sealing member mounted around the outer surface of the frame and fixed to the struts of the frame and the plurality of connecting skirts, the plurality of connecting skirts mounted around the inner surface of the frame.

[0012] The various innovations of this disclosure may be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form, which will be further described in the detailed description below. This summary is not intended to identify any major or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other purposes, features, and merits of this disclosure will become more apparent from the detailed description, claims, and accompanying drawings below. [Brief explanation of the drawing]

[0013] [Figure 1A] This is a perspective view of an artificial heart valve according to one embodiment. [Figure 1B] Figure 1A is a perspective view of an artificial valve, where components outside the frame are indicated by transparent lines for illustrative purposes. [Figure 2]This is a side view of an artificial heart valve, according to another embodiment, with components outside the frame of the artificial heart valve removed, including a connecting skirt that connects the pointed edges of the valve leaflets to the frame of the artificial heart valve. [Figure 3] Figure 2 is a detailed view of the inner surface of an artificial heart valve. [Figure 4] This is a side view of an embodiment of a delivery device configured to deliver and implant a radially expandable artificial heart valve at an implantation site. [Figure 5] Figure 4 is a side view of the distal end of the delivery device, which is equipped with an artificial heart valve attached to the valve mounting portion of the delivery device. [Figure 6] Figure 2 shows a cross-sectional view of an artificial heart valve, radially compressed and mounted on an inflatable balloon of a delivery device. [Figure 7] A side view of an artificial heart valve according to another embodiment, with components outside the frame of the artificial heart valve removed, which includes a connecting skirt that connects the pointed portion of the valve leaflet to the frame of the artificial heart valve, the connecting skirt including a lateral extension that covers the apex at the inlet end of the frame. [Figure 8] Figure 7 is a side view of the frame of the artificial heart valve. [Figure 9] This is a plan view of an embodiment of a connecting skirt for connecting the pointed edge of the valve leaflet to the frame of the artificial heart valve shown in Figure 7. [Figure 10] Figure 7 is a plan view of an example of the valve leaflets of an artificial heart valve. [Figure 11] Figure 10 is a perspective view of the valve leaflet in its folded configuration. [Figure 12] This is a cross-sectional view of the artificial valve shown in Figure 7, illustrating the exemplary attachment of the pointed edge portion of the valve leaflet to the frame via the connecting skirt of Figure 9. [Figure 13] Figure 9 is a plan view of the connecting skirt, showing the folding method for securing the connecting skirt to the valve leaflet. [Figure 14] Figure 10 is a plan view of the inner surface of the valve leaflets, illustrating the connecting skirts shown in Figure 9, which are positioned along the inner surface of the pointed edges of the valve leaflets and attached to them. [Figure 15]Figure 10 is a plan view of the outer surface of the valve tip, showing the connection skirt of Figure 9 attached to the edge portion of the valve tip. [Figure 16] Figure 10 is a plan view of the valve tip, including the connection skirt of Figure 9 and a reinforcing member positioned along the edge portion of the valve tip. [Figure 17] Figure 7 is a plan view of a plurality of valve tips and connection skirts fixedly assembled together to form a valve leaflet structure for an artificial heart valve. [Figure 18] Figure 10 is an exploded perspective view of the valve tip of Figure 10 and the connection skirt of Figure 9, which is in a configuration for attachment to the frame of Figure 8. [Figure 19] Figure 12 is a detailed view of the connection skirt of Figure 9, fixed to the strut of the frame of Figure 8, as viewed from inside the frame. [Figure 20] Figure 15 is a detailed view of the connection skirt of Figure 9, fixed to the strut of the frame of Figure 8, as viewed from outside the frame. [Figure 21] Figure 18 is a detailed perspective view from the inside of the artificial heart valve of Figure 7, showing the inner surfaces of two extension portions of two adjacent connection skirts and the connection between the two extension portions. [Figure 22] Figure 21 is a perspective view of the artificial heart valve of Figure 7, showing a method for fixing an outer sealing member to the outer surface of the strut of the frame of the artificial heart valve. [Figure 23] Figure 24 is a plan view of an example of a crosslinked attachment member, shown in a flattened configuration. [Figure 24] Figure 27 is a perspective view of one of the crosslinks of the artificial heart valve of Figure 7, the crosslink including the crosslinked attachment member of Figure 23. [Figure 25] Figure 30 is a cross-sectional view of one of the crosslinks of the artificial heart valve of Figure 7, the crosslink including the crosslinked attachment member of Figure 23. [Figure 26] Figure 33 is a cross-sectional view of the artificial heart valve of Figure 7, radially compressed on and around the expandable balloon of the delivery device.

DETAILED DESCRIPTION OF THE INVENTION

[0014] General Considerations For the purposes of this specification, specific aspects, advantages, and novel features of the embodiments of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as limiting in any way. Rather, this disclosure covers all novel and non-obvious features and aspects of the various disclosed embodiments, both individually and in various and partial combinations with one another. The methods, apparatus, and systems are not limited to any particular aspect or feature, or any combination thereof, nor is it necessary for any one or more particular advantages or problems to be solved in the disclosed embodiments.

[0015] While some of the operations in the disclosed embodiments are described in a specific sequential order for convenience of presentation, it should be understood that this method of description includes reordering unless a specific order is required by certain terms set forth below. For example, operations described sequentially may, in some cases, be reordered or performed simultaneously. Furthermore, for the sake of simplification, the accompanying drawings may not show various ways in which the disclosed methods may be used in combination with other methods. In addition, terms such as “provide” or “achieve” are sometimes used in this specification to describe the disclosed methods. These terms are high-level abstractions of the actual operations performed. The actual operations corresponding to these terms may vary depending on the particular implementation and will be readily recognizable to those skilled in the art.

[0016] In this application and claims, the singular forms "a," "an," and "the" include the plural form unless the context otherwise explicitly indicates. In addition, the term "includes" means "comprises." Furthermore, the term "coupled" generally means to be physically, mechanically, chemically, magnetically, and / or electrically coupled or linked, and does not exclude the existence of intermediate elements between coupled or associated items unless a specific opposite expression is used.

[0017] As used in this specification, the term "proximal" refers to a location, orientation, or part of the device that is closer to the user and further away from the implantation site. As used herein, the term "distal" refers to a location, orientation, or part of the device that is further away from the user and closer to the implantation site. For example, proximal movement of the device is movement of the device away from the implantation site and toward the user (e.g., out of the patient's body), while distal movement of the device is movement of the device away from the user and toward the implantation site (e.g., into the patient's body). Unless otherwise explicitly defined, the terms "longitudinal" and "axial" refer to axes extending in the proximal and distal directions. Examples of the disclosed technology

[0018] This specification describes examples of artificial heart valves, leaflet assemblies for artificial heart valves, connecting skirts, and methods for assembling leaflet assemblies and valve structures to an artificial heart valve frame using one or more connecting skirts. The artificial heart valve may comprise a frame and a valve structure attached to the frame, the valve structure comprising a plurality of leaflets. In some embodiments, the connecting skirt may be fixed to the pointed portion of the leaflets of the valve structure. The portion of the connecting skirt fixed to the leaflet pointed portion may then be fixed to a strut of the artificial heart valve frame, thereby fixing the leaflet pointed portion to the frame in close proximity to the inlet end of the frame. The connecting skirt may include a lateral extension portion that extends outward from the leaflet pointed portion and across the strut of the frame positioned between adjacent leaflet pointed portions when the connecting skirt is attached to the strut of the frame. In this way, the lateral extension portion can cover the inner surface of the strut of the frame and / or the apex of the frame at the inlet end of the frame.

[0019] The prosthetic valves disclosed herein may be radially compressible and expandable between a radially compressed configuration and a radially expanded configuration. Thus, the prosthetic valve may be compressed or held in a radially compressed configuration on an implant delivery device during delivery, and then expanded to a radially expanded configuration upon reaching the implantation site. It is understood that the prosthetic valves disclosed herein may be used with various implant delivery devices and may be implanted via various delivery procedures, examples of which will be described in more detail later. In some embodiments, the prosthetic valve may be deployed from the delivery device at the implantation site (e.g., a cardiac valve) by inflating an inflatable balloon of the delivery device. When radially compressed on the inflatable balloon of the delivery device, the inner surface of the prosthetic valve frame may face the balloon.

[0020] Figure 1A shows an exemplary prosthetic valve 150 according to one embodiment. Any prosthetic valve disclosed herein is adapted to be implanted in the patient's own aortic annulus, but in other embodiments it may be adapted to be implanted in other annulus of the heart (pulmonary valve, mitral valve, and tricuspid valve). The disclosed prosthetic valve may also be implanted in the pulmonary artery (to replace the function of an affected pulmonary valve), or in the superior or inferior vena cava (to replace the function of an affected tricuspid valve), or in any blood vessel communicating with the heart, including various other veins, arteries, and blood vessels of the patient. The disclosed prosthetic valve may also be implanted in a valve-in-valve procedure within a previously implanted prosthetic valve (which may be a prosthetic surgical valve or a prosthetic transcatheter heart valve).

[0021] In some embodiments, the disclosed prosthetic valve may be implanted in a docking device or anchoring device implanted in a native heart valve or blood vessel. For example, in one embodiment, the disclosed prosthetic valve may be implanted in a docking device implanted in a pulmonary artery to replace the function of a diseased pulmonary valve, as disclosed, for example, in U.S. Patent Application Publication 2017 / 0231756, which is incorporated herein by reference. In another embodiment, the disclosed prosthetic valve may be implanted in a native mitral valve or in a docking device implanted therein, as disclosed, for example, in International Publication 2020 / 247907, which is incorporated herein by reference. In yet another embodiment, the disclosed prosthetic valve may be implanted in a docking device implanted in the superior or inferior vena cava to replace the function of a diseased tricuspid valve, as disclosed, for example, in U.S. Patent Application Publication 2019 / 0000615, which is incorporated herein by reference.

[0022] Figure 1A is a perspective view of an artificial heart valve (e.g., a prosthetic valve) 150 according to one embodiment. The illustrated prosthetic valve is adapted to be implanted in the annulus of the aortic valve, but in other embodiments it may be adapted to be implanted in other annulus of the heart (e.g., the pulmonary valve, mitral valve, and tricuspid valve). The prosthetic valve may also be adapted to be implanted in other tubular organs or passages in the body.

[0023] The artificial valve 150 may have three main components: a stent or frame 152, a valve membrane structure 154, and a sealing member 156. Figure 1B is a perspective view of the artificial valve 150, with components outside the frame 152 (including the sealing member 156) shown by transmissive lines for illustrative purposes. The artificial valve 150 may have an inlet end 166 and an outlet end 168.

[0024] The valve structure 154 may comprise three leaflets 160 that collectively form a leaflet structure, which can be arranged to collapse in a tricuspid valve configuration, although in other embodiments, there may be more or fewer leaflets (e.g., one or more leaflets 160). In some embodiments, the leaflets 160 may be formed from pericardial tissue (e.g., bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials known in the art and incorporated herein by reference, as described in U.S. Patent No. 6,730,118.

[0025] Each valve leaflet 160 may be coupled to the frame 152 in a commissure 164 of the valve membrane structure 154, along its inlet edge 162 (also referred to as the lower edge or "pointed edge" in the figure) and in which adjacent portions of two valve leaflets (e.g., commissure tabs) are connected to each other. In some embodiments, the commissure 164 may comprise a cell of the frame 152 (e.g., a commissure cell) and an attachment member (e.g., fabric, flexible polymer, or the like) disposed across the cell formed by the frame's struts. The attachment member may be fixed to the frame struts forming the cell, and adjacent portions of two valve leaflets may be connected to the attachment member (e.g., as shown in Figures 2 and 23-25, as further described below) to form the commissure 164.

[0026] In some embodiments, reinforcing elements or connecting skirts, such as fabric strips, can be connected directly to the tips of the valve leaflets and to the frame supports to connect the tips of the valve leaflets to the frame (for example, as shown in Figures 2 and 3, as will be further described below).

[0027] The frame 152 can be made of either a variety of suitable plastically expandable materials (e.g., stainless steel) or a self-expanding material (e.g., nickel-titanium alloy (NiTi) such as Nitinol) known in the art. When constructed from a plastically expandable material, the frame 152 (and thus the prosthetic valve 150) is crimped into a radially collapsed configuration on a delivery device (e.g., a catheter) and can then be expanded inside the patient by an inflatable balloon or equivalent expansion mechanism. When constructed from a self-expanding material, the frame 152 (and thus the prosthetic valve 150) is crimped into a radially collapsed configuration and can be constrained in the collapsed configuration by insertion into the sheath of the delivery device or equivalent mechanism. Once inside the body, the prosthetic valve can be advanced from the delivery sheath, which allows the prosthetic valve to expand to its functional size.

[0028] Suitable plastically expandable materials that may be used to form frame 152 include, but are not limited to, stainless steel, biocompatible high-strength alloys (e.g., cobalt-chromium or nickel-cobalt-chromium alloys), polymers, or combinations thereof. In certain embodiments, frame 152 is made of a nickel-cobalt-chromium-molybdenum alloy such as MP35N® alloy (SPS Technologies, Jenkintown, Pennsylvania), which is equivalent to UNS R30035 alloy (coated by ASTM F562-02). MP35N® alloy / UNS R30035 alloy contains 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum by weight.

[0029] In the illustrated embodiment, the frame 152 comprises a plurality of circumferentially extending rows of angled supports 172 that define a row of open cells or openings 174 of the frame. The frame 152 may have a cylindrical or substantially cylindrical shape with a constant diameter from the inlet end 166 to the outlet end 168 of the frame 152, as shown, or the frame 152 may have a diameter that changes along the height of the frame, as disclosed in U.S. Patent Application Publication 2012 / 0239142, which is incorporated herein by reference.

[0030] The frame 152 may have a plurality of vertices 180 spaced apart from each other around the circumference of the frame 152 at each of the inlet end 166 and the outlet end 168.

[0031] In the illustrated embodiment, the sealing member 156 is mounted on the outside of the frame 152 and functions to create a seal against surrounding tissue (e.g., self-feedings and / or self-rings) to prevent or at least minimize perivalve leakage. The sealing member 156 may comprise an inner layer 176 (which may be in contact with the outer surface of the frame 152) and an outer layer 178. The sealing member 156 may be connected to the frame 152 using a preferred technique or mechanism. For example, the sealing member 156 may be sutured to the frame 152 via sutures that extend around the support 172 and through the inner layer 176. In an alternative embodiment, the inner layer 176 may be mounted on the inner surface of the frame 152, while the outer layer 178 is on the outside of the frame 152.

[0032] The outer layer 178 may be configured or molded to extend radially outward from the inner layer 176 and frame 152 when the prosthetic valve 150 is deployed. When the prosthetic valve is fully expanded outside the patient's body, the outer layer 178 can expand away from the inner layer 176 to create a space between the two layers. Thus, when implanted inside the body, this allows the outer layer 178 to expand to come into contact with the surrounding tissue.

[0033] Further details relating to the artificial valve 150 and its various components are described in U.S. Patent Application Publication No. 2018 / 0028310, which is incorporated herein by reference.

[0034] Figure 2 is a side view of an artificial heart valve 200 according to another embodiment. The artificial heart valve 200 may be similar to the artificial valve 150 in Figures 1A and 1B. For example, the artificial heart valve 200 may include a frame 202 and a valve structure 204, which may be identical or similar to the frame 152 and valve structure 154 of the artificial valve 150. For example, the frame 202 and valve structure 204 may contain materials similar to and / or have similar geometry to the frame 152 and valve structure 154 of the artificial valve 150, respectively, as described above with reference to Figures 1A and 1B.

[0035] In Figure 2, the exterior of the frame 202 is shown without any sealing members arranged around the frame, thereby providing a diagram of the components that connect the valve structure 204 to the frame 202. However, in some embodiments, the artificial heart valve 200 may include an outer sealing member (e.g., an outer skirt) arranged around the outer surface of the frame 202 and coupled thereto, such as the sealing member 156 shown in Figure 1A.

[0036] For example, Figure 3 is a partial detail view of the inner surface of the artificial heart valve 200, showing the outer sealing member 206 arranged around the outer surface of the frame 202. Thus, Figure 2 is an external view, and Figure 3 is an internal view of the artificial heart valve 200.

[0037] Similar to the frame 152 of the artificial valve 150, the frame 202 of the artificial heart valve 200 comprises a plurality of angled interconnected struts 208. As shown in Figure 2, the struts 208 may be arranged in a plurality of circumferentially extending rows of angled struts 208 positioned between the inlet end 210 and the outlet end 212 of the frame 202. The rows of struts 208 define a row of cells or openings (e.g., open cells) 214 of the frame 202. The frame 202 may have a plurality of spaced vertices 254 around the circumference of the frame 202 at each of the inlet end 210 and the outlet end 212. The vertices 254 may be formed by the intersection of struts 208 at the inlet end 210 and the outlet end 212. Furthermore, the frame 202 may include a plurality of column joints 256 formed by the intersection of the columns 208 at positions on the frame 202 between the inlet end 210 and the outlet end 212.

[0038] As shown in Figure 2, each leaflet 216 of the valve structure 204 may be coupled to the frame 202 along its inlet edge (also referred to as the “apex edge”) and in a commissure 238 of the valve structure 204 where adjacent portions of two leaflets (e.g., commissure tabs) are connected to each other. In some embodiments, as shown in Figure 2 and as further described below, the commissure 238 may comprise a mounting member 220 (e.g., fabric, flexible polymer, or the like) disposed across a cell 214 (e.g., commissure cell) of the frame 202. The mounting member 220 may be fixed to a support 208 of the frame 202 forming the cell 214 via stitching or sutures 248. Furthermore, adjacent portions of two leaflets 216 may be connected to the mounting member 220 to form a commissure 238 (e.g., as shown in Figure 2 and as further described below with reference to Figures 7 and 23-25).

[0039] In some embodiments, as shown in Figures 2 and 3, the tips 218 of the valve leaflets 216 can be joined (e.g., fixed) to the frame 202 by a connecting skirt (or member) 260. For example, in some embodiments, the tips 218 of each valve leaflet 216 can be directly connected to a corresponding (e.g., individual) connecting skirt 260. Then, each connecting skirt 260 (e.g., one for each valve leaflet 216) can be directly connected to a support 208 of the frame 202, thereby joining the tips 218 of the valve leaflets 216 to the frame. In other embodiments, the connecting skirt 260 may be a single piece of material connected to all the valve leaflets 216.

[0040] For example, as shown in Figure 2, the connecting skirt 260 may be fixed to the support joint 256 by a first suture 272, and further connected to the support 208 along its length by a second suture 274 (for example, in the form of a whip stitch).

[0041] As shown in Figure 3, a portion of the support column 208 of the frame 202 and a portion of the apex 254 of the inlet end 210 are exposed on the inside of the frame 202, between the adjacent valve leaflets 216 and the connecting skirt 260.

[0042] Figures 4 and 5 show an embodiment of a delivery device 300 that may be used to implant an expandable artificial heart valve (e.g., artificial valve 150 in Figures 1A and 1B and / or artificial heart valve 200 in Figures 2 and 3), or another type of expandable artificial medical device (such as a stent). In some embodiments, the delivery device 300 is specifically adapted for use when introducing an artificial valve into the heart.

[0043] The delivery device 300 of the embodiment illustrated in Figures 4 and 5 is a balloon catheter comprising a handle 302 and a maneuverable outer shaft 304 extending distally from the handle 302 (Figure 4). The delivery device 300 may further comprise an intermediate shaft 306 (which may also be called a balloon shaft) extending proximal and distally from the handle 302, the portion extending distally from the handle 302 also extending coaxially through the outer shaft 304. In addition, the delivery device 300 may further comprise an inner shaft 308 extending coaxially distally from the handle 302 through the intermediate shaft 306 and the outer shaft 304 (Figure 4), and coaxially proximal from the handle 302 through the intermediate shaft 306.

[0044] The outer shaft 304 and the intermediate shaft 306 may be configured to translate (e.g., move) longitudinally relative to each other along the central longitudinal axis 320 of the delivery device 300 to facilitate the delivery and positioning of the artificial valve at the implantation site within the patient's body.

[0045] The intermediate shaft 306 may include a proximal end portion 310 that extends proximal from the proximal end of the handle 302 to the adapter 312 (Figure 4). In some embodiments, a rotatable knob 314 may be mounted on the proximal end portion 310 (Figure 4) and may be configured to rotate the intermediate shaft 306 relative to the outer shaft 304 around the central longitudinal axis 320 of the delivery device 300.

[0046] The adapter 312 may include a first port 338 configured to receive a guidewire through it, and a second port 340 configured to receive fluid (e.g., expansion fluid) from a fluid source. The second port 340 may be fluidically coupled to the inner lumen of the intermediate shaft 306.

[0047] The intermediate shaft 306 may further include a distal end portion 316 that extends distally beyond the distal end of the outer shaft 304 when the distal end of the outer shaft 304 is positioned away from the inflatable balloon 318 of the delivery device (Figure 4). The distal end portion of the inner shaft 308 may extend distally beyond the distal end portion 316 of the intermediate shaft 306 (Figure 4).

[0048] The balloon 318 can be coupled to the distal end portion 316 of the intermediate shaft 306. For example, in some embodiments, the proximal end portion of the balloon 318 can be coupled to and / or around the distal end of the intermediate shaft 306 (Figure 4).

[0049] The balloon 318 may include a distal end portion (or section) 332, a proximal end portion (or section) 333, and an intermediate portion (or section) 335, the intermediate portion 335 being positioned between the distal end portion 332 and the proximal end portion 333 (Figure 4).

[0050] In some embodiments, the distal end of the distal end portion 332 of the balloon 318 may be coupled to the distal end of the delivery device 300, for example, to the nose cone 322 (as shown in Figures 4 and 5), or to an alternative component at the distal end of the delivery device 300 (e.g., the distal shoulder). In some embodiments, the intermediate portion 335 of the balloon 318 may overlap the valve-fitting portion 324 of the distal end portion 309 of the delivery device 300, the distal end portion 332 may overlap the distal shoulder 326 of the delivery device 300, and the proximal end portion 333 may surround a portion of the inner shaft 308. The valve-fitting portion 324 and the intermediate portion 335 of the balloon 318 may be configured to receive the artificial heart valve 370 in a radially compressed state, as shown in Figure 5. In some embodiments, the artificial heart valve 370 shown in Figure 5 may be one of the valves 150 in Figures 1A and 1B or the valves 200 in Figures 2 and 3.

[0051] In some embodiments, rotation of the intermediate shaft 306 may result in rotation of the balloon 318 and the artificial valve mounted thereon, for rotational positioning of the artificial valve relative to the natural anatomical structure at the target implantation site.

[0052] The balloon shoulder assembly is configured to maintain the artificial heart valve or other medical device in a fixed position on the balloon 318 during delivery through the patient's vascular system. The balloon shoulder assembly may include a distal shoulder 326 (Figures 4 and 5) disposed within the distal end portion 332 of the balloon 318 and coupled to the distal end portion of the inner shaft 308. The distal shoulder 326 may be configured to resist the movement of the artificial valve or other medical device mounted distally on the valve attachment portion 324 relative to the balloon 318 in an axial direction (e.g., along the central longitudinal axis 320).

[0053] The outer shaft 304 may include a distal tip portion 328 mounted on its distal end (Figures 4 and 5). The outer shaft 304 and the intermediate shaft 306 may be axially translated relative to each other to position the distal tip portion 328 adjacent to the proximal end of the valve mounting portion 324 when the prosthetic valve is mounted radially compressed on the valve mounting portion 324 (for example, as shown in Figure 5) and during delivery of the prosthetic valve to the target implantation site. Thus, the distal tip portion 328 may be configured to resist the movement of the prosthetic valve relative to the balloon 318 axially and proximal when the distal tip portion 328 is positioned adjacent to the proximal side of the valve mounting portion 324 (Figure 5).

[0054] In some embodiments, the nose cone 322 may be positioned distal to the distal shoulder portion 326 and coupled to the distal shoulder portion 326. In some embodiments, the nose cone 322 may be coupled to the distal end portion of the inner shaft 308.

[0055] In some embodiments, the annular space may be defined between the outer surface of the inner shaft 308 and the inner surface of the intermediate shaft 306. In some embodiments, the annular space may be referred to as the inner lumen of the intermediate shaft 306. In some embodiments, the annular space may be configured to receive fluid from a fluid source via a second port 340 of the adapter 312 (e.g., the annular space is in fluid communication with the second port 340 of the adapter 312). The annular space may be fluidically coupled to a fluid passage formed between the outer surface of the distal end portion of the inner shaft 308 and the inner surface of the balloon 318. Thus, fluid from the fluid source can flow to the balloon 318, inflating the balloon 318 and radially expanding and deploying an artificial valve (e.g., the artificial valve 370 shown in Figure 5).

[0056] The inner lumen of the inner shaft 308 may be configured to receive a guidewire through it in order to navigate the distal end portion 309 of the delivery device 300 to the target implantation site. As described above, the first port 338 of the adapter 312 may be connected to the inner lumen and configured to receive a guidewire. For example, the distal end portion 309 of the delivery device 300 can be advanced on the guidewire to the target implantation site.

[0057] As shown in Figure 4, the handle 302 may include a steering mechanism configured to adjust the curvature of the distal end portion 309 of the delivery device 300. In the illustrated embodiment, for example, the handle 302 includes an adjustment member such as the illustrated rotatable knob 360, which is operably coupled to the proximal end portion of the pull wire. The pull wire may extend distally from the handle 302 through an outer shaft 304 and has a distal end portion attached to the outer shaft 304 at or near the distal end of the outer shaft 304. Rotating the knob 360 increases or decreases the tension of the pull wire, thereby adjusting the curvature of the distal end portion 309 of the delivery device 300. Further details of steering or bending mechanisms for delivery devices can be found in U.S. Patent No. 9,339,384, which is incorporated herein by reference.

[0058] The handle 302 may include one or more additional adjustment mechanisms. For example, in some embodiments, the handle 302 may include an adjustment mechanism 361 which includes an adjustment member such as the rotatable knob 362 shown. The adjustment mechanism 361 may be configured to adjust the axial position of the intermediate shaft 306 relative to the outer shaft 304. In some embodiments, the handle 302 may further include a locking mechanism which may include a rotatable knob 379, configured to hold (e.g., lock) the position of the intermediate shaft 306 relative to the handle 302, allowing for fine positioning of the artificial valve 370 at the implantation site.

[0059] Figure 6 is a cross-sectional view of the artificial heart valve 200 (Figures 2 and 3), which is radially compressed on the balloon 318 and mounted around the balloon 318 on the distal end portion 309 of the delivery device 300. Specifically, the cross-sectional view in Figure 6 is taken at the inlet end 210 of the frame 202. Therefore, the vertex 254 of the frame 202 at the inlet end 210 is visible in Figure 6.

[0060] As shown in Figure 6, the balloon 318 is wound and folded around the inner shaft 308 at the valve mounting portion 324 of the delivery device 300. In some embodiments, as shown in Figure 6, the balloon 318 includes a plurality of overlapping pleats or folds 390 when it is in its deflated configuration and when the artificial heart valve 200 is mounted on the balloon 318 and radially compressed around it. The balloon 318 can be folded such that the pleats 390 (for example, in its deflated configuration) result in a minimized folded balloon diameter that can reduce the diameter of the radially compressed artificial valve 200 when it is crimped on it.

[0061] As shown in Figures 2 and 3, and as described above, the inner surfaces 224 of a portion of the vertex 254 and support column 208 (for example, the interior of the valve 200 and the surface facing the central longitudinal axis of the valve 200) located between the adjacent connecting skirts 260 and the frame 202 are exposed (for example, not covered by the skirt or valve leaf material). For example, as shown in Figure 3, the exposed portion 222 of the frame 202 has an uncovered inner surface 224.

[0062] Therefore, as shown in Figure 6, if the balloon 318 is compressed or radially compressed, at least a portion of the inner surface 224 of the apex 254 at the inlet end 210 of the frame 202 may come into direct contact with the balloon 318. As a result, this may cause wear or deterioration of the balloon 318, thereby resulting in reduced or insufficient inflation of the balloon 318 when attempting to deploy the artificial heart valve 200 to the implantation site.

[0063] Figures 7-12 show an assembled artificial heart valve 400 (Figures 7 and 12) and individual components of the artificial heart valve 400 (Figures 8-11) according to another embodiment. Figures 13-25 show a method for assembling the components of the artificial heart valve 400 to form the assembled artificial heart valve 400. Figure 26 is a cross-sectional view of the artificial heart valve 400 radially compressed on and around the balloon 318 of the delivery device 300.

[0064] The artificial heart valve 400 may be similar to the artificial valve 200 in Figures 2 and 3. However, the artificial heart valve 400 is configured such that wear or deterioration of the balloon is reduced or prevented when the artificial heart valve 400 is radially compressed on the balloon of the delivery device.

[0065] For example, the artificial heart valve 400 may include a frame 202 and a valve structure 204 connected to the frame 202, as described above. The artificial heart valve 400 may have a central longitudinal axis 402 positioned through the center inside the frame 202. The frame 202 of the artificial heart valve 400 is shown alone in Figure 8. An exemplary valve leaflet 216 of the valve structure 204 is shown in a flat (unfolded) configuration in Figure 10 and in an exemplary folded configuration in Figure 11. The folded configuration of the valve leaflet 216 shown in Figure 11 may represent the shape of the valve leaflet when attached to the frame 202, as will be described later. The outer surface 482 of the valve leaflet 216 facing the frame 202 after assembly to the frame 202 is shown in Figure 11.

[0066] Each valve leaflet 216 may have a lower or pointed portion 416 (Figure 10) which can be attached to the frame 202 by a connecting skirt 410, as further described herein. During assembly to the frame 202, the lower pointed portion 416 may be folded toward the frame 202, as shown in Figures 11 and 12, as will be described in more detail later.

[0067] As shown in Figure 10, the pointed portion 416 terminates at its upper end with two integrated lower tabs 418 that project laterally. As shown in Figure 11, during assembly to the frame 12, the lower tabs 418 can be folded onto the outer surface 482. Projecting from the upper corner of the valve leaflet 216 is an integrated upper tab 420 (also called a commissure tab). The upper tab 420 is spaced from the lower tab 818 by its lateral edge 419 and can form a gap or recess 417 that extends laterally into the valve leaflet 216. Furthermore, as will be described later and as shown in Figure 11, the upper tab 420 can be folded and overlapped with itself to form a commissure.

[0068] In alternative embodiments, the valve leaflets of the valve structure 204 may be configured differently from those shown in Figures 10 and 11, for example, by having upper tabs of different shapes or recesses 417 of different sizes.

[0069] As shown in Figure 7, the artificial heart valve 400 includes a plurality of connecting skirts (e.g., members) 410 that connect the pointed portion 416 of the valve leaflets 216 to the frame 202 (e.g., instead of connecting skirts 260). For example, each connecting skirt 410 can secure the pointed portion 416 of one valve leaflet 216 to the frame 202. Thus, in the illustrated example, there are a plurality of individual connecting skirts 410 (one for each valve leaflet 216) formed from separate pieces of material (e.g., separate pieces of cloth). In an alternative embodiment, the artificial valve may have a single connecting skirt used to connect all valve leaflets to the frame. The single connecting skirt may have different sections aligned along the pointed portion 416 of the valve leaflets 216.

[0070] The connecting skirt 410 includes a side portion 406 having an extension 414 that covers the inner surface of the struts 208 (including the apex 254) between adjacent valve leaflets 216 at the inlet end 210 of the frame 202 (Figure 7). As a result, the inner surfaces of the apex 254 and struts 208 at the inlet end 210 of the frame 202 are covered, and the connecting skirt 410 can act as a barrier between the apex 254 and struts 208 and the balloon 318 when the artificial heart valve is compressed radially over and around the balloon 318 (further explanation below with reference to Figure 26).

[0071] A single connecting skirt 410 of the artificial heart valve 400 is shown in Figure 9. In some embodiments, the connecting skirt 410 may include a synthetic material such as cloth (e.g., PET cloth) or a natural tissue material (e.g., pericardial tissue). In the illustrated example, a single connecting skirt 410 is provided for the apical portion 416 of each valve leaflet 216 and is sized to extend along the entire length of the apical portion 416 to a position just below the lower tab 418 of the valve leaflet 216 (Figure 10).

[0072] Figure 14 shows a connecting skirt 410 positioned along the inner surface 480 of the pointed edge portion 416 of the valve leaflet 216 and attached to the pointed edge portion 416 of the valve leaflet 216. As shown in Figure 9, the connecting skirt 410 may include a central portion 404 sized to cover and extend over the central portion 413 (e.g., the central pointed edge portion 413) of the pointed edge portion 416 of the valve leaflet 216, and two side portions 406 sized to cover and extend over the corresponding angled side edge portions 415 of the pointed edge portion 416 of the valve leaflet 216. As shown in Figure 10, each angled side edge portion 415 may extend from the central portion 413 to one of the lower tabs 418 of the valve leaflet 216.

[0073] Each side portion 406 of the connecting skirt 410 may include a base portion 412 (also called a side base portion) and an extension portion 414 (also called a side extension portion) extending outward from the base portion 412. In some embodiments, as shown in Figure 9, each extension portion 414 of the corresponding side portion 406 may be triangular. In some embodiments, the base portion 412 and the central portion 404 may be rectangular.

[0074] For example, each extension 414 may include a first angled edge 460 extending at an angle from and outward from the free end 461 of the base portion 412 of the corresponding side portion 406. Each extension 414 may further include a vertical edge 462 extending outward from the end of the base portion 412 connected to the central portion 404 of the connecting skirt 410. The vertical edge 462 may be parallel to the free end 461 of the base portion 412 of the corresponding side portion 406. The extension 414 may further include a second angled edge 463 extending at an angle from and outward from the vertical edge 462 (for example, away from the base portion 412). The first angled edge 460 and the second angled edge 463 may intersect at a point 465 that is spaced outward away from the base portion 412. Therefore, the extension 414 of the side portion 406 extends outward and passes through the central portion 404 of the connecting skirt 410.

[0075] In some embodiments, the angle 459 between the first angled edge 460 and the second angled edge 463 may be in the range of about 45 degrees to about 120 degrees, about 75 degrees to about 100 degrees, or about 85 degrees to about 95 degrees.

[0076] Therefore, depending on the shape of the side portion 406 of the connecting skirt 410, the connecting skirt 410 may have a relatively straight first edge 471 (e.g., the bottom edge in Figure 9) extending across the central portion 404 and the two side base portions 412, and a non-linear second edge 469 (e.g., the top edge in Figure 9) extending from one free end 461 of the base portion 412 of the side portion 406 to the other free end 461 of the base portion 412 of the side portion 406. The first edge 471 and the second edge 469 may be positioned opposite each other across the connecting skirt 410. Furthermore, the second edge 469 may include a plurality of different angled edges.

[0077] In some embodiments, together the central portion 404 and the two base portions 412 may be referred to as the base portion of the connecting skirt, and the two extension portions 414 may extend outward from the base portion.

[0078] The connecting skirt 410 is formed with a slit 408 that partially separates the side portion 406 from the central portion 404 (Figure 9), which can facilitate the alignment of the connecting skirt 410 along the pointed edge portion 416 of the valve leaflet 216, as shown in Figure 14. For example, the slit 408 may be configured to allow the base portion 412 of the side portion 406 to bend (for example, at a certain angle) relative to the central portion 404.

[0079] In an alternative embodiment, multiple connecting skirts can be provided for the pointed portion 416 of each valve leaflet 216 (for example, the central portion 404 and the lateral portion 406 may be separate pieces of fabric). In another embodiment, a single connecting skirt can be used to secure all valve leaflets 216 to the frame 202 (for example, a single connecting skirt can be sized to extend along all the pointed portions 416 of the valve leaflets 216 of the valve membrane structure 204).

[0080] In some embodiments, each connecting skirt 410 may include a plurality of openings configured as suture holes, which are configured to receive stitches or sutures for attaching the connecting skirt 410 to the valve leaflets 216 and / or the frame 202. For example, in some embodiments, the openings may include a first row of openings 484, a second row of openings 486, a third row of openings 488, and a fourth row of openings 490, each comprising a plurality of openings spaced apart from one another along the length of the base portion 412 of each side portion 406 and central portion 404 (Figures 9 and 13). In some embodiments, each extension portion 414 of the connecting skirt 410 may also include one or more openings 492 (Figure 9) which can be used to fasten each extension portion 414 to another extension portion 414 of an adjacent connecting skirt 410 (for example, shown in Figure 7). In some embodiments, one or more openings 492 are located within the extension portion adjacent to (for example, spaced along) the first angled edge portion 460.

[0081] Figures 12-25 show assemblies and methods for assembling the valve structure 204 to the frame 202, which include methods for attaching the connecting skirts 410 to their respective valve leaflets 216 (Figures 13-16), methods for forming the valve structure 204 (Figure 17), methods for attaching the connecting skirts 410 to the frame 202 (Figures 19-21), and methods for forming the commissures and attaching the commissures to the frame 202 (Figures 23-25).

[0082] To attach the connecting skirt 410 to the corresponding valve leaflet 216, the base portion 412 of the side portion 406 and the central portion 404 can first be folded and overlapped in themselves (for example, in half), as shown by arrow 494 in Figure 13. For example, folding the base portion 412 and the central portion 404 longitudinally (as shown in Figure 13), as shown in the cross-sectional view of Figure 12, can form two folded layers 464a, 464b, with the extension portion 414 extending outward from one of the two folded layers (for example, folded layer 464b in Figure 12).

[0083] Next, the folded base portion 412 and central portion 404 may be positioned along the inner surface 480 of the pointed portion 416 of the valve leaflet 216 (Figure 14). For example, as described above and as shown in Figure 14, the folded central portion 404 may be positioned on the central portion 413 of the pointed portion 416 of the valve leaflet 216, and each base portion 412 may be positioned on the corresponding angled lateral portion 415 of the pointed portion 416 of the valve leaflet 216.

[0084] As shown in Figure 14, in some embodiments, adjacent portions of the central portion 404 and each base portion 412 may overlap within the area of ​​the slit 408 by bending the base portion 412 relative to the central portion 404, which is facilitated by the slit 408.

[0085] The extension 414 of the side portion 406 of the connecting skirt 410 separates from the pointed portion 416 and extends across a portion of the inner surface 480 of the valve leaflet 216. In some embodiments, as shown in Figure 14, the two extensions 414 of the connecting skirt 410 overlap each other in the region of their point 465.

[0086] As shown in Figure 14, after the connecting skirt 410 is positioned on the inner surface 480 of the valve leaflet 216, the folded base portion 412 and central portion 404 can be fixed to the apical portion 416. For example, the folded base portion 412 and central portion 404 can be fixed to the apical portion 416 via one or more sutures (e.g., stitching) 468 that form a stitch line 467 along the apical portion 416 (Figures 12 and 14). In some embodiments, the stitch line 467 may include multiple in-stitches and out-stitches that extend through the apical portion 416 of the valve leaflet 216, as well as through the overlapping openings of the second row of openings 484 and the third row of openings 488 of the connecting skirt 410. For example, when the base portion 412 and the central portion 404 of the connecting skirt 410 are folded as described above and as shown in Figure 14, the two central rows of openings (for example, the second row of openings 486 and the third row of openings 488 shown in Figure 13) overlap each other, thereby forming a single row of double-layered openings configured to receive institches and outstitches of one or more sutures 468.

[0087] Figure 14 shows the inner surface 480 of the valve leaflet 216, while Figure 15 shows the outer surface 482 opposite to the valve leaflet 216. The connecting skirt 410 is located behind the valve leaflet 216 in the diagram of Figure 14, so the edge of the connecting skirt 410 is shown by a dashed line. A stitch line 467 formed by one or more sutures 468 can be seen on the outer surface 482 of the valve leaflet 216 (Figure 15).

[0088] As shown in Figures 14 and 15, the valve leaflets 216 and the attached connecting skirt 410 together form a valve leaflet assembly 485, which may be referred to as such herein.

[0089] In some embodiments, a reinforcing member or cord 466 (e.g., Ethibond suture) may be positioned against the outer surface 482 of the pointed portion 416 opposite the connecting skirt 410 (Figure 16). The reinforcing cord 466 and the folded layers 464a, 464b may be sutured together with each other and to the pointed portion 416 by stitching 474, which may be a single or multiple sutures extending through one or more layers of material (Figure 12).

[0090] In some embodiments, when the reinforcing cord 466 is sutured to the valve leaflet 216, the lower tab 418 may be folded downward relative to the apical portion 416 (see Figure 16), and the reinforcing cord 466 may be positioned over the folded lower tab 418. The upper end of the connecting skirt 410 may be sized to extend over the folded lower tab 418. Stitching 474 can be used to secure the reinforcing cord 466 in place relative to the folded lower tab 418 (Figure 12).

[0091] In some embodiments, a single reinforcing cord 466 may extend continuously along the pointed portions 416 of all the valve leaflets 216 of the valve diaphragm structure 204 and through the space beneath each commissure 498. In other embodiments, multiple reinforcing cords 466 may be used in conjunction with one reinforcing cord fixed to the pointed portion of each valve leaflet 216. When multiple reinforcing cords 466 are used, the end of each cord may be connected to an adjacent end of another cord (for example, by tying or knotting). For example, the adjacent ends of two cords may be connected to each other in the space beneath the commissure.

[0092] Each connecting skirt 410 is fixed to each respective valve leaflet 216 to form a valve leaflet assembly 485. After this assembly, the valve leaflet assemblies 485 (for example, three as shown in Figure 17) can be fixed together as shown in Figure 17 to form a valve structure 204. The valve structure 204 comprises three valve leaflets 216 and valve leaflet assemblies 285, but in alternative examples, the valve leaflet structures for the prosthetic valves discussed herein may have a different number of valve leaflets, such as two leaflets.

[0093] As shown in Figure 17, the three leaflet assemblies 485 are arranged together in a flat configuration, with the pointed edges 416 of the leaflets 216 forming the outer circumference of the valve membrane structure 204, and the upper tabs 420 from adjacent leaflets 216 folded upward and positioned to touch each other. The three leaflet assemblies 485 can be fixed together (e.g., sutured or otherwise fastened) via one or more sutures 422 (Figures 14 and 15) along each of the pointed edges 416 of each leaflet 216 and between them, forming stitch lines 424 (Figure 17).

[0094] In some embodiments, one or more tails 425 of one or more sutures 422 may be connected to the support 208 of the frame 202.

[0095] Once the valve leaflet assembly 485 is fixed together, the valve structure 204 can be positioned inside the frame 202 and fixed to the frame 202, as shown in Figures 7, 12, and 19-24.

[0096] To secure the pointed portion 416 of each valve leaflet 216 of the valve structure 204 to the frame 202, the folded portion on the central portion 404 and base portion 412 of each connecting skirt 410 can be fixed (e.g., sutured) to the struts 208 of the frame 202. In some embodiments, one or more sutures 470 (forming a stitch) can be used to secure the pointed portion 416 of the valve leaflet 216 to the frame 202 by extending along the length of the pointed portion 416 through the folded portion on the central portion 404 and base portion 412 of each connecting skirt 410 and around the struts 208 of the frame 202 (Figures 19 and 20).

[0097] For example, Figures 19 and 20 show detailed views of one or more sutures 470 that secure the connecting skirt 410 to the support 208 of the frame 202, as seen from inside the frame 202 (Figure 19) and outside the frame 202 (Figure 20). As described above, when the central portion 404 and base portion 412 of each connecting skirt 410 are folded over as shown in Figures 19 and 20, the first row of openings 484 and the fourth row of openings 490 (Figures 9 and 13) of the connecting skirt 410 can overlap to form a single row of openings configured to receive stitches from one or more sutures 470 (Figures 19 and 20). The overlapping openings are numbered in Figures 19 and 20 to indicate the correspondence between the inner surface (Figure 19) and the outer surface (Figure 20) of the connecting skirt 410.

[0098] In some embodiments, one or more stitches 470 may pass through the folded portion of the connecting skirt 410, around the support 208 (as shown in the appearance in Figure 20), and then return through the connecting skirt 410 to extend to the inner surface of the frame 202 (as shown in Figure 19). These stitches may be repeated along the length of the central portion 404 and base portion 412 of each connecting skirt 410 (for example, along the pointed portion 416 of the valve leaflet 216), thereby connecting each connecting skirt 410 to a first set or portion of the support 208 that extends at an angle from the first commissur 498 to the inlet end 210 and from the inlet end to the second commissurur 498 (Figures 7 and 22).

[0099] In some embodiments, the stitches formed by one or more sutures 470 may include multiple whip stitches. In some embodiments, individual stitches 472 can secure each connecting skirt 410 to the corresponding post joint 256 (Figures 7 and 20). Thus, in some embodiments, as shown in Figures 7 and 12, the two folded layers 464a and 464b of each connecting skirt 41 can be secured to the post joint 256 by individual stitches 472 and whip stitches of one or more sutures 470 formed along the length of the post 208 between the two post joints 256.

[0100] In some embodiments, one or more whipstitches of sutures 470 can optionally extend through the pointed portion 416 of the flap leaflet 216.

[0101] In some embodiments, as described above, attaching the connecting skirt 410 to the frame 202 may cause the pointed portion 416 of the valve leaflet 216 to fold over itself toward the frame 202, as shown in Figures 11, 12, and 18. As a result, the inner surface 480 of the pointed portion 416 now faces the inner surface of the frame 202. Furthermore, as a result of this folding, the folded layer 464a of the connecting skirt 410 faces the inner surface of the frame 202 (Figures 12 and 18), and the extended portion 414 of the connecting skirt 410 folds away from the inner surface 480 of the valve leaflet 216 toward the inner surface of the frame 202 (Figures 12 and 18). For example, Figure 18 is an exploded perspective view of the valve leaflet 216 and connecting skirt 410 as they would appear when attached to the frame 202.

[0102] As a result of the folding of the pointed edge portions 416 of the valve leaflets 216 when attached to the frame 202, the extension portion 414 can cover a second set or portion of the support column 208 and the vertex 254 of the frame 202, which are positioned at the inlet end 210 between the pointed edge portions 416 of adjacent valve leaflets 216 (Figures 7, 19, and 20).

[0103] In some embodiments, portions of two adjacent extensions 414 of two adjacent connecting skirts 410 overlap each other, thereby forming an overlapping extension 476. As shown in Figures 7, 21, and 22, in some embodiments, the overlapping extension 476 may be fastened together via one or more sutures 478 (or other similar fasteners or fastening members) thereby fastening the two extensions 414 of the two adjacent connecting skirts 410 to each other. In some embodiments, the extension 476 may be fastened by the sutures 478 or by additional sutures to a support of the frame 202, such as a support joint 256 over which the extension 476 overlaps.

[0104] Figure 21 is a perspective detail view of the inner surfaces of the extensions 414 of two adjacent connecting skirts 410 and the inner surfaces 480 of two adjacent valve leaflets 216 (e.g., from the inside of the valve and frame 202). In contrast, Figures 7 and 22 show the external appearance of the artificial heart valve 400 and the outer surface of the extensions 414 of the connecting skirts 410.

[0105] As shown in Figure 21, the extension 414 of the connecting skirt 410 extends onto and covers the inner surface of the strut 208 and apex 254, which are positioned between adjacent valve leaflets 216 at the inlet end 210 of the frame 202. As a result, the connecting skirt 410 is positioned between the frame 202 and the interior 496 of the artificial heart valve 400 (Figures 12 and 22).

[0106] Therefore, as shown in Figure 26, when the artificial heart valve 400 is radially compressed around and on the inflatable balloon of the delivery device (e.g., balloon 318), the material of the connecting skirt 410 is positioned between the vertex 254 of the frame 202 and the balloon 318, thereby acting as a protective barrier between the support 208 of the frame 202 and the balloon 318. As a result, balloon degradation can be reduced and / or prevented.

[0107] The valve structure 204 can be further secured to the frame 202 by forming commissures 498 and attaching them to the frame 202, as shown in the exemplary methods presented in Figures 23-35. As introduced above and as shown in Figure 10, each valve leaflet 216 may include a lower tab 418 and an upper tab 420 (also called a commissure tab). The upper tab 420 may be spaced from the lower tab 418 by a lateral edge 419 to form a gap or recess 417 that extends laterally within the valve leaflet.

[0108] As shown in Figures 10 and 16, each upper tab 420 can be folded along a fold line 423 to form first and second tab layers 420a and 420b. The upper tabs 420 can be fixed to the coupling mounting member 431 together with the upper tabs 420 of adjacent valve leaflets, as will be further described below, to form a coupling 498. Figure 23 shows the coupling mounting member 431 in a flattened configuration before folding and attachment to the valve leaflets. In the illustrated configuration, each coupling mounting member 431 comprises first and second side portions 428a and 428b projecting laterally from a central portion 430. As shown, the outer peripheral edges 432 of the side portions 428a and 428b may be shaped to correspond to half of the rhombic cells 214 of the frame 202 in order to facilitate attachment of the coupling mounting member 431 to the support columns 208 of the frame 202, as will be further described below.

[0109] Referring to Figures 24 and 25, after the upper tab 420 of the valve leaflet 216 is folded, the vertical reinforcement 426 can be fixed to the inner surface of the tab layer 420a, for example, by stitching. The folded tab layers 420a, 420b can be fixed to the side portion 428a or 428b of the connecting attachment member 431. The folded tab layers 420a, 420b can also be folded along a vertical fold line in the L-shaped reinforcement 426 such that the tab layer 420b forms a first circumferentially extending layer 434a and a first radially extending layer 434b that is generally perpendicular to layer 434a, and the tab layer 420a forms a second inner circumferentially extending layer 436a and a radially extending layer 436b that is generally perpendicular to layer 436a. Another upper tab 420 of an adjacent valve leaflet 216 can be similarly folded and secured to another side portion 428a or 428b of the coupling mounting member 431.

[0110] The joint mounting member 431 can be folded as shown in Figure 25 to form an inner layer 438, two intermediate layers 440, and two outer layers 442. Each folded upper tab 420 can be fastened to the inner layer 438 and the intermediate layer 440 with stitches 444. In the illustrated example, stitches 444 extending through the reinforcing member 426, layer 436a, layer 434a, layer 438, and layer 440 are shown. However, during the assembly process, multiple stitches can be used to fasten each layer to an adjacent layer as each fold is created. For example, layers 434a and 436a can be fastened to each other and to the reinforcing member 426 with separate stitches, then the leaflet layer can be fastened to the inner layer 438 of the joint mounting member 431 with additional stitches, and the intermediate layer 440 can be fastened to the inner layer 438 with further stitches. As best shown in Figure 25, the connecting member 431 can be folded, leaving a small gap 446 between the outer layers 442.

[0111] The outer layer 442 can be fixed to the frame 12, for example, by stitching its outer peripheral edge 432 to the support column 208 with stitching 448 (Figures 24 and 25). As described above, the outer peripheral edge 432 of the cross-connecting attachment member 431 can generally correspond to the shape of the closed cells of the frame 202. For example, as shown in Figure 8, the frame 202 of the illustrated embodiment includes a plurality of generally rhomboid cells 214, each formed by support columns 208a, 208b, 208c, and 208d. The outer peripheral edge 432 of the cross-connecting attachment member 431 can be stitched to the support columns 208a, 208b, 208c, and 208d forming the closed cells 214 using stitching 448. The cross-connecting attachment member 431 may further include an upper tab 450 and a lower tab 452 protruding from the upper and lower edges of the central portion (Figure 23). Stitching 448 can also be used to sew the apex 254 of the upper tab 450 formed by the intersection of struts 208a and 208c, and to sew the lower tab 452 to the strut joint 256 formed by the intersection of struts 208b and 208d (Figures 7 and 8).

[0112] Additional details regarding the method for forming the commissures 498 and securing them to the frame 202 of the artificial heart valve are described in U.S. Patent Application Publication No. 2018 / 0028310, which is incorporated herein by reference.

[0113] In some embodiments, after the valve structure 204 is fixed to the frame 202 as described above, the outer sealing member 454 can be attached around the outer surface 456 of the frame 202 (Figures 12 and 22). For example, as shown in Figure 22 by arrow 457, the outer sealing member 454 can be slid over the outside of the frame 202 so as to cover at least a portion of the connecting skirt 410 located inside the frame 202. In some embodiments, as shown in Figure 12, the outer sealing member 454 can then be fixed 458 to the outer surface 456 of the frame 202 and the connecting skirt 410 via one or more sutures 458 (or other fastening members). As an example, Figure 22 shows a dashed outline 495 around a portion of the support and a connecting skirt 410 to which the outer sealing member 454 can be fixed via one or more sutures 458. In some embodiments, additional sutures or fasteners can be used to directly secure portions of the outer sealing member 454 to the support posts 208 of the frame 202 (for example, the top and bottom or edges of the outer sealing member 454).

[0114] In this way, the leaflets of a valve structure can be attached to the frame of an artificial heart valve using one or more connecting skirts. For example, the central and lateral base portions of the connecting skirt may be directly fixed to the pointed edges of the corresponding leaflets, or the central and lateral base portions of the connecting skirt may be directly fixed to the struts of the frame, thereby fixing the attached leaflets to the frame. Each connecting skirt may further include lateral extensions that extend across the struts of the frame positioned between the pointed edges of adjacent leaflets (for example, when the valve structure is attached to the frame as described above). As a result, the lateral extensions of the connecting skirts can cover the inner surfaces of the struts and apex at the inlet end of the frame, which would otherwise be exposed by the leaflets. Thus, when the artificial heart valve is radially compressed on and around the inflatable balloon of the delivery device, the extensions of the connecting skirts can act as a protective barrier between the balloon and the apex and struts of the frame. As a result, the lifespan and effectiveness of the balloon (e.g., its ability to inflate) can be increased. Delivery method

[0115] To implant a prosthetic valve into the patient's own aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end of the delivery device. The prosthetic valve and the distal end of the delivery device are inserted into the femoral artery and advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned within the patient's own aortic valve and expanded radially (for example, by inflating a balloon, activating one or more actuators of the delivery device, or by deploying the prosthetic valve from its sheath and allowing it to expand on its own). Alternatively, the prosthetic valve can be implanted into the patient's own aortic valve via a transapical approach, in which case the prosthetic valve (on the distal end of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and at the apex of the heart, and the prosthetic valve is positioned within the patient's own aortic valve. Alternatively, in transaortic procedures, the prosthetic valve (on the distal end of the delivery device) is introduced into the aorta through a surgical incision in the ascending aorta, for example, by a partial J-sternotomy or a mini-thoracotomy in the right parasternal region, and then advanced through the ascending aorta towards the native aortic valve.

[0116] To implant a prosthetic valve into the patient's own mitral valve via a transseptal delivery approach, the prosthetic valve is fitted in a radially compressed state along the distal end portion of the delivery device. The prosthetic valve and the distal end portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava into the right atrium, across the atrial septum (through a puncture made in the atrial septum) into the left atrium, and toward the patient's own mitral valve. Alternatively, the prosthetic valve can be implanted into the patient's own mitral valve via a transapical approach, in which case the prosthetic valve (on the distal end portion of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and at the apex of the heart, and the prosthetic valve is positioned within the patient's own mitral valve.

[0117] To implant a prosthetic valve within the patient's own tricuspid valve, the prosthetic valve is fitted in a radially compressed state along the distal end of the delivery device. The prosthetic valve and the distal end of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava, and into the right atrium, where the prosthetic valve is positioned within the patient's own tricuspid valve. A similar approach may be used to implant a prosthetic valve within the patient's own pulmonary valve or pulmonary artery, except that the prosthetic valve is advanced through the patient's own tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0118] Another delivery approach is the transatrial approach, in which the prosthetic valve (on the distal end portion of the delivery device) is inserted through a chest incision and an incision made through the atrial wall (of either the right or left atrium) to access either the native heart valve. Atrial delivery may also be performed intravascularly, for example, through the pulmonary vein. Yet another delivery approach is the transventricular approach, in which the prosthetic valve (on the distal end portion of the delivery device) is inserted through a chest incision and an incision made through the wall of the right ventricle (typically at or near the base of the heart) to implant the prosthetic valve into the native tricuspid valve, native pulmonary valve, or pulmonary artery.

[0119] In all delivery approaches, the delivery device can be advanced along a guidewire previously inserted into the patient's vascular system. Furthermore, the disclosed delivery approaches are not intended to be limiting. Any artificial valve disclosed herein can be implanted using any of the various delivery procedures and delivery devices known in the art. Additional examples of the disclosed technology

[0120] In consideration of the above-described implementations of the subject matter disclosed, this application discloses additional embodiments listed below. It should be noted that one feature of an embodiment alone, or two or more features of an embodiment incorporated in combination, and optionally in combination with one or more features of one or more further embodiments, are further embodiments similarly included within the disclosure of this application.

[0121] Example 1. An artificial heart valve comprising an annular frame having an inlet end and an outlet end, which is radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration, wherein the frame comprises an annular frame having a plurality of supports, and a valve structure mounted within the frame and having a plurality of valve leaflets, wherein each valve leaflet comprises opposing tabs on opposing sides of the valve leaflet and a pointed edge portion between the tabs, the pointed edge portion of each valve leaflet being connected to the frame by a connecting skirt, each connecting skirt comprising a central portion and opposing side base portions on opposing sides of the central portion, each connecting skirt further comprising a side extension portion extending outward from the pointed edge portion of the valve leaflet and across a support of the frame positioned between adjacent valve leaflet pointed edges.

[0122] Example 2. Any embodiment of this specification, in particular the artificial heart valve described in Example 1, wherein a plurality of struts form a plurality of vertices at the inlet and outlet ends of the frame, and each lateral extension of each connecting skirt extends across the struts of the frame positioned between adjacent valve leaflets, such that the inner surface of each vertex of the plurality of vertices located at the inlet end of the frame is covered by the corresponding lateral extension of the corresponding connecting skirt.

[0123] Example 3. An artificial heart valve according to any embodiment of this specification, in particular Example 1 or Example 2, wherein each lateral extension extends over one or more cells of a plurality of open cells defined by a plurality of struts, and one or more cells are exposed by a plurality of valve leaflets.

[0124] Example 4. An artificial heart valve according to any embodiment of this specification, in particular any one of Examples 1 to 3, wherein each lateral extension is fixed to an adjacent lateral extension of an adjacent connecting skirt.

[0125] Example 5. Any embodiment of the specification, in particular the artificial heart valve according to Example 4, wherein each lateral extension portion includes one or more openings located on the angled edge of the lateral extension portion, and each lateral extension portion is secured to an adjacent lateral extension portion of an adjacent connecting skirt via one or more sutures extending through one or more openings.

[0126] Example 6. An artificial heart valve according to any embodiment of this specification, in particular any one of Examples 1 to 5, wherein each connecting skirt includes one or more notches positioned between a central portion and a side base portion configured to allow the side base portion to bend relative to the central portion.

[0127] Example 7. An artificial heart valve according to any embodiment of this specification, in particular any one of Examples 1 to 6, wherein each lateral extension of each connecting skirt is triangular and is formed by two angled edges extending outward from the opposing ends of each lateral base portion of the connecting skirt.

[0128] Example 8. An artificial heart valve according to any embodiment of this specification, in particular any one of Examples 1 to 7, wherein each connecting skirt includes multiple rows of openings located within and extending across the lateral base portion and the central portion.

[0129] Example 9. Any embodiment of this specification, in particular the artificial heart valve described in Example 8, wherein for each valve leaflet, the central portion and lateral base portion of the connecting skirt are positioned along and secured to the apical edge portion of the valve leaflet via one or more sutures extending through the first two rows of multiple openings.

[0130] Example 10. Any embodiment of this specification, in particular the artificial heart valve described in Example 9, wherein for each valve leaflet, the central portion and lateral base portion of the connecting skirt fixed to the leaflet are further fixed to a support of one of the multiple support posts of the frame via one or more sutures extending through the second two of the multiple rows of openings.

[0131] Example 11. Any embodiment of this specification, in particular the artificial heart valve according to Example 10, wherein the central portion and the lateral base portion are folded longitudinally along the pointed edge portion of the valve leaflet to form two folded portions such that the first two rows overlap each other and the second two rows overlap each other.

[0132] Example 12. An artificial heart valve according to any embodiment of this specification, in particular any one of Examples 1 to 11, wherein each valve leaflet and each connecting skirt are fixed to each adjacent valve leaflet and each adjacent connecting skirt along the pointed edge portions of a plurality of valve leaflets, thereby forming a valve structure.

[0133] Example 13. An artificial heart valve according to any embodiment of this specification, in particular any one of Examples 1 to 12, wherein each tab of the opposing tabs of each valve leaflet pairs with the adjacent tab of the adjacent valve leaflet to form a plurality of commissures connected to the frame at the outflow end of the frame.

[0134] Example 14. Any embodiment of this specification, in particular the artificial heart valve according to Example 13, wherein each lateral extension covers the inner surface of the frame support positioned between the frame support, which is connected to the commissures of a plurality of commissures and the inlet end of the frame.

[0135] Example 15. An artificial heart valve according to any embodiment of this specification, in particular any one of Examples 1 to 14, further comprising an outer sealing member mounted on the outer surface of the frame and fixed to each connecting skirt.

[0136] Example 16. Any embodiment of this specification, in particular the artificial heart valve described in Example 15, wherein the outer sealing member extends from the inlet end of the frame toward the outlet end of the frame.

[0137] Example 17. An artificial heart valve comprising an annular frame having an inlet end and an outlet end, which is radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration, wherein the frame comprises an annular frame having a plurality of supports; a valve structure mounted within the frame and having a plurality of leaflets, each leaflet comprising opposing tabs on opposing sides of the leaflet and a pointed edge portion between the tabs, and each tab pairing with an adjacent tab of an adjacent leaflet to form a plurality of commissures connected to the frame; and a plurality of connecting skirts, each connecting skirt comprising a lateral base portion and a central portion connected to each of the pointed edge portions of a corresponding leaflet among the plurality of leaflets and to a support of the frame, each connecting skirt further comprising a lateral extension portion extending outward from the pointed edge portion, and each lateral extension portion of each connecting skirt extending across the support of the frame between the pointed edge portions of adjacent leaflets and connecting to an adjacent lateral extension portion of an adjacent connecting skirt, wherein the plurality of connecting skirts

[0138] Example 18. Any embodiment of this specification, in particular Example 17, of an artificial heart valve, wherein each lateral extension is connected to an adjacent lateral extension of an adjacent connecting skirt, from a column joint to which a corresponding commissure among a plurality of commissures is connected, to the inlet end of the frame.

[0139] Example 19. An artificial heart valve according to any embodiment of this specification, particularly Example 17 or Example 18, wherein each lateral extension extends from the pointed edge of the corresponding valve leaflet to the inlet end of the frame, covering the inner surface of the apex of the frame at the inlet end.

[0140] Example 20. An artificial heart valve according to any embodiment of this specification, in particular any one of Examples 17 to 19, wherein each connecting skirt includes two side base portions, each positioned on an opposing side of a central portion, and two side extension portions, each side extension portion extending outward from the corresponding side base portions of the two side base portions.

[0141] Example 21. Any embodiment of this specification, in particular the artificial heart valve described in Example 20, wherein each lateral extension is triangular.

[0142] Example 22. An artificial heart valve according to any embodiment of this specification, in particular Example 20 or Example 21, wherein the two side base portions and the central portion of each connecting skirt are rectangular.

[0143] Example 23. An artificial heart valve according to any embodiment of this specification, in particular any one of Examples 20-22, wherein for each connecting skirt, two side base portions and a central portion form a straight first edge of the connecting skirt, and two side extension portions form a non-straight second edge located opposite the first edge, and the non-straight second edge has a plurality of angled edges.

[0144] Example 24. An artificial heart valve according to any embodiment of this specification, in particular any one of Examples 20 to 23, wherein each lateral extension portion of each connecting skirt includes an angled edge extending from the free end of the corresponding lateral base portion, and each lateral extension portion includes one or more openings located adjacent to the angled edge and disposed therein.

[0145] Example 25. Any embodiment of this specification, in particular Example 24, of an artificial heart valve, wherein each lateral extension portion at least partially overlaps and is connected to an adjacent lateral extension portion of an adjacent connecting skirt by one or more sutures extending through one or more openings in each of the lateral extension portions and the adjacent lateral extension portions.

[0146] Example 26. An artificial heart valve according to any embodiment of this specification, in particular any one of Examples 20 to 25, wherein each connecting skirt includes a plurality of rows of openings within a central portion and two side base portions, each row of openings having multiple openings spaced apart from one another and extending from the free end of one side base portion of the two side base portions to the other side base portion of the two side base portions.

[0147] Example 27. An artificial heart valve according to any embodiment of this specification, in particular Example 26, wherein the multiple rows of openings include four rows of openings spaced apart from one another, and the central portion and two side base portions are folded longitudinally such that two folded layers are formed, and the first and fourth rows of openings of the four rows of openings overlap each other, and the second and third rows of openings of the four rows of openings overlap each other, and are positioned along the pointed edges of the corresponding valve leaflets.

[0148] Example 28. Any embodiment of this specification, in particular the artificial heart valve according to Example 27, wherein each connecting skirt is secured to the apical portion of the corresponding valve leaflet via one or more sutures extending through the second and third row openings.

[0149] Example 29. Any embodiment of this specification, in particular the artificial heart valve described in Example 28, wherein each connecting skirt is secured to a frame support via one or more sutures extending through the first and fourth rows of openings.

[0150] Example 30. An artificial heart valve according to any embodiment of this specification, in particular any one of Examples 20-29, wherein each connecting skirt includes a slit that partially separates two lateral base portions from the central portion, allowing the connecting skirt to align along the pointed edge portion of the corresponding valve leaflet.

[0151] Example 31. Any embodiment of this specification, in particular the artificial heart valve described in Example 30, wherein the pointed edge portion of each valve leaflet includes a central portion and two angled lateral edge portions extending from both sides of the central portion to one of each of the opposing tabs.

[0152] Example 32. An artificial heart valve according to any embodiment of this specification, in particular any one of Examples 17 to 31, wherein a plurality of struts form a plurality of open cells, and each of a plurality of commisses is positioned across a cell of the plurality of open cells located at the outflow end of the frame.

[0153] Example 33. Any embodiment of this specification, in particular the artificial heart valve described in Example 32, wherein the lateral extension portion of an adjacent connecting skirt extends across a cell among a plurality of open cells located between the cell containing the commissure and the inlet end of the frame.

[0154] Example 34. An artificial heart valve according to any embodiment of this specification, in particular any one of Examples 17 to 33, further comprising an outer sealing member mounted around the outer surface of a frame and fixed to the frame's support columns and a plurality of connecting skirts, wherein the plurality of connecting skirts are mounted around the inner surface of the frame.

[0155] Example 35. A method for assembling an artificial heart valve including a plurality of leaflets, the method comprising forming a plurality of leaflet assemblies with the plurality of leaflets, wherein each leaflet assembly is formed by fixing the central portion and lateral base portion of a connecting skirt to the pointed edge portion of a leaflet, wherein each connecting skirt includes two lateral portions, one on each side of the central portion, and each lateral portion includes a corresponding lateral base portion of the lateral base portion and a lateral extension portion extending outward from the corresponding lateral base portion; fixing each connecting skirt to the frame of an artificial heart valve, wherein the frame comprises a plurality of interconnected angled struts, and the fixing includes fixing the central portion and lateral base portion of the connecting skirt to a first strut of the plurality of struts; and extending each lateral extension portion of the connecting skirt over a second strut of a plurality of struts positioned between adjacent leaflet edges, and fixing each lateral extension portion to an adjacent lateral extension portion of an adjacent connecting skirt.

[0156] Example 36. Any embodiment of this specification, particularly the method of Example 35, wherein fixing the central portion and the side base portion of the connecting skirt to the pointed edge of the valve leaflet includes folding the central portion and the side base portion longitudinally to form two folded layers, and fixing the two folded layers to the pointed edge of the valve leaflet.

[0157] Example 37. Any embodiment of this specification, in particular the method of Example 36, wherein each connecting skirt includes multiple rows of openings extending along a central portion and a side base portion, and two folded layers are secured to the apice portion of the valve leaflet, one or more sutures are extended through the apice portion of the valve leaflet, and the openings of the first two rows of multiple rows of openings are overlapped along the length of the apice portion, thereby securing the central portion and the side base portion of the connecting skirt to the apice portion of the valve leaflet.

[0158] Example 38. The method according to any embodiment of this specification, particularly Example 36 or Example 37, wherein the central portion and the side base portion of the connecting skirt are fixed to the pointed edge portion of the valve leaflet, while each side extension of the connecting skirt extends outward from the two folded layers and across the inner surface of the valve leaflet.

[0159] Example 39. The method according to any embodiment of this specification, in particular any one of Examples 36 to 38, wherein the central portion and the side base portion of the connecting skirt are fixed to the first portion of the support by fixing the two folded layers of the connecting skirt to the first portion of the support via one or more sutures that extend around the first portion of the support along the length of the pointed portion of the valve leaflet, through the overlapping openings of the second two rows of openings of a plurality of rows of openings and around the first portion of the support.

[0160] Example 40. The method according to any embodiment of this specification, in particular any one of Examples 35-39, wherein each lateral extension of the connecting skirt extends over the second portion of the support, thereby covering the inner surface of the second portion of the support and the apex of the frame located at the inlet end of the frame with the lateral extension.

[0161] Example 41. The method according to any embodiment of this specification, in particular any one of Examples 35 to 39, wherein each side extension is fixed to an adjacent side extension of an adjacent connecting skirt, and the overlapping portions of the side extensions and adjacent side extensions are fixed together via one or more sutures.

[0162] Example 42. Any embodiment of this specification, particularly the method of Example 41, wherein securing the overlapping portion together includes extending one or more sutures through the overlapping portion from a support joint where the pointed edges of adjacent valve leaflets intersect with the inlet end of the frame.

[0163] Example 43. The method according to any embodiment of this specification, in particular any one of Examples 35 to 42, further comprising forming a plurality of valve leaflet assemblies, connecting the plurality of valve leaflet assemblies together to form a valve membrane structure, arranging the valve membrane structure inside the frame, and then fixing each connecting skirt to the frame.

[0164] Example 44. Any embodiment of this specification, particularly the method of Example 43, wherein the formation of a valve structure by connecting multiple valve leaflet assemblies together comprises extending one or more sutures through each connecting skirt and each leaflet's edge portion to form a stitch line along and between each leaflet's edge portion of the valve structure.

[0165] Example 45. The method according to any embodiment of this specification, in particular any one of Examples 35 to 44, further comprising each valve leaflet having opposing tabs on opposing sides of the apical edge portion of the valve leaflet, each tab being paired with an adjacent tab of an adjacent valve leaflet to form a commissure, and the commissure being fixed to a frame.

[0166] Example 46. Any embodiment of this specification, in particular the method of Example 45, wherein fixing the crossbar to the frame includes fixing the crossbar to a third portion of a column among a plurality of columns forming a cell at the outflow end of the frame.

[0167] Example 47. Any embodiment of this specification, particularly the method of Example 45 or Example 46, wherein the first portion of the support is a support extending at an angle from the first intersection to the inlet end of the frame and at an angle from the inlet end to the second intersection.

[0168] Example 48. The method according to any embodiment of this specification, in particular any one of Examples 45 to 47, wherein each side extension is fixed to an adjacent side extension of an adjacent connecting skirt by extending one or more sutures through the overlapping portion of the side extension and the adjacent side extension, extending from the cross to the inlet end of the frame.

[0169] Example 49. Any embodiment of this specification, in particular the method of any one of Examples 35 to 48, further comprising attaching the outer sealing member around the outer surface of the frame and securing the outer sealing member to the frame's support and each connecting skirt.

[0170] Example 50. An artificial heart valve comprising: an annular frame having an inlet end and an outlet end, which is radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration, wherein the frame comprises an annular frame having a plurality of supports; a valve structure mounted within the frame and having a plurality of leaflets, each leaflet comprising opposing tabs on opposing sides of the leaflet and a pointed edge portion between the tabs, and each tab pairing with an adjacent tab of an adjacent leaflet to form a plurality of commissures connected to the frame; a plurality of connecting skirts, each connecting skirt comprising a base portion connected to each of the pointed edge portions of a corresponding leaflet among the plurality of leaflets and to the supports of the frame, each connecting skirt further comprising an extension portion extending outward from the pointed edge portion and covering the inner surface of the supports of the frame positioned between the pointed edge portions of adjacent leaflets; and an outer sealing member mounted around the outer surface of the frame and fixed to the supports of the frame and the plurality of connecting skirts, wherein the plurality of connecting skirts are mounted around the inner surface of the frame.

[0171] Example 51. An artificial heart valve according to any embodiment of this specification, in particular the one described in Example 50, wherein a portion of the frame support covered by the extensions of each valve leaflet forms a apex at the inlet end of the frame.

[0172] Example 52. An artificial heart valve according to any embodiment of this specification, in particular example 50 or example 51, wherein the base portion of each connecting skirt comprises a central portion and opposing side base portions positioned on both sides of the central portion, and each extension of the connecting skirt extends outward from each of the opposing side base portions.

[0173] Example 53. An artificial heart valve according to any embodiment of this specification, in particular any one of Examples 50 to 52, wherein the extension portion is triangular.

[0174] Example 54. An artificial heart valve according to any embodiment of this specification, in particular any one of Examples 50 to 53, wherein each extension portion of each connecting skirt is attached to an adjacent extension portion of an adjacent connecting skirt.

[0175] Example 55. An artificial heart valve according to any embodiment of this specification, in particular Example 54, wherein each extension is attached to an adjacent extension within the region of the frame, positioned axially with respect to the central longitudinal axis of the frame, between a commissure of a plurality of commissures and the inlet end of the frame.

[0176] Given the many possible embodiments to which the principles of the disclosed technology may be applied, it should be recognized that the examples shown are merely embodiments of the disclosed technology and should not be considered to limit the scope of the claimed subject matter. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

1. It is an artificial heart valve, An annular frame having an inlet end and an outlet end, which is radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration, wherein the frame comprises a plurality of support columns, A valve structure mounted within the frame and comprising a plurality of valve leaflets, wherein each valve leaflet comprises opposing tabs on opposing sides of the valve leaflet and a pointed edge portion between the tabs, An artificial heart valve wherein the pointed edge portion of each valve leaflet is connected to the frame by a connecting skirt, and each connecting skirt comprises a central portion and opposing lateral base portions on opposing sides of the central portion, each connected to and positioned between the frame and the pointed edge portion of the valve leaflet, and each connecting skirt further comprises lateral extension portions extending outward from the pointed edge portion of the valve leaflet and across a support of the frame positioned between adjacent valve leaflet pointed edges.

2. The artificial heart valve according to claim 1, wherein the plurality of support columns form a plurality of vertices at the inlet and outlet ends of the frame, and each lateral extension of each connecting skirt extends across the support columns of the frame, which are positioned between adjacent valve leaflets, such that the inner surface of each vertex of the plurality of vertices, which are positioned at the inlet end of the frame, is covered by the corresponding lateral extension of the corresponding connecting skirt.

3. The artificial heart valve according to claim 1 or claim 2, wherein each lateral extension extends over one or more cells of a plurality of open cells defined by the plurality of supports, and the one or more cells are not covered by the plurality of valve leaflets.

4. The artificial heart valve according to any one of claims 1 to 3, wherein each side extension is fixed to an adjacent side extension of an adjacent connecting skirt.

5. The artificial heart valve according to any one of claims 1 to 4, wherein each connecting skirt includes one or more notches positioned between the central portion and the side base portion configured to allow the side base portion to bend relative to the central portion.

6. The artificial heart valve according to any one of claims 1 to 5, wherein each side extension of each connecting skirt is triangular, and is formed by two angled edges extending outward from opposing ends of each side base portion of the side base portion of the connecting skirt.

7. An artificial heart valve according to any one of claims 1 to 6, wherein each connecting skirt is positioned within the lateral base portion and the central portion and includes a plurality of rows of openings extending across the lateral base portion and the central portion, and for each valve leaflet, the central portion and the lateral base portion of the connecting skirt are positioned along the pointed edge portion of the valve leaflet and fixed to the pointed edge portion of the valve leaflet via one or more sutures extending through the first two rows of the plurality of openings.

8. The artificial heart valve according to claim 7, wherein, for each valve leaflet, the central portion and the side base portion of the connecting skirt fixed to the valve leaflet are further fixed to a support of the frame of the plurality of support columns via one or more sutures extending through the second two rows of the plurality of openings.

9. The artificial heart valve according to claim 8, wherein the central portion and the side base portion are folded vertically along the pointed edge portion of the valve leaflet to form two folded portions such that the first two rows overlap each other and the second two rows overlap each other.

10. An artificial heart valve according to any one of claims 1 to 9, wherein each tab of the opposing tabs of each valve leaflet pairs with an adjacent tab of an adjacent valve leaflet to form a plurality of commissures connected to the frame at the outflow end of the frame.

11. The artificial heart valve according to claim 10, wherein each lateral extension covers the inner surface of the support columns of the frame, which are positioned between the support columns of the frame, and the support columns of the frame are connected to the commissures among the plurality of commissures and the inlet end of the frame.

12. The artificial heart valve according to any one of claims 1 to 11, further comprising an outer sealing member attached to the outer surface of the frame and fixed to each connecting skirt.

13. A method for assembling an artificial heart valve that includes multiple valve leaflets, The plurality of valve leaflets form a plurality of valve leaflet assemblies, wherein each valve leaflet assembly is The central portion and side base portion of the connecting skirt are fixed to the pointed edge portion of the valve leaflet, and each connecting skirt includes two side portions, one on each side of the central portion, and each side portion includes a corresponding side base portion of the side base portion and a side extension portion extending outward from the corresponding side base portion, thereby forming a plurality of valve leaflet assemblies. The method involves fixing each connecting skirt to the frame of the artificial heart valve, wherein the frame comprises a plurality of interconnected angled supports, and the method involves fixing each connecting skirt to the frame of the artificial heart valve. The central portion and the side base portion of the connecting skirt are fixed to the first portion of the support column among the plurality of support columns, Each side extension of the connecting skirt extends across the second portion of the support column among the plurality of support columns arranged between the pointed edges of adjacent valve leaflets, and each side extension is fixed to the adjacent side extension of the adjacent connecting skirt. A method comprising securing each of the connecting skirts to the frame of the artificial heart valve.

14. The method according to claim 13, wherein fixing the central portion and the side base portion of the connecting skirt to the pointed portion of the valve leaflet includes folding the central portion and the side base portion longitudinally to form two folded layers, and fixing the two folded layers to the pointed portion of the valve leaflet, wherein each connecting skirt includes a plurality of rows of openings extending along the central portion and the side base portion, and fixing the two folded layers to the pointed portion of the valve leaflet includes extending one or more sutures through the pointed portion of the valve leaflet, and overlapping the openings of the first two rows of openings of the plurality of rows of openings along the length of the pointed portion, thereby fixing the central portion and the side base portion of the connecting skirt to the pointed portion of the valve leaflet.

15. The method according to claim 14, wherein fixing the central portion and the side base portion of the connecting skirt to the first portion of the support column involves fixing the two folded layers of the connecting skirt to the first portion of the support column by means of one or more sutures that extend around the first portion of the support column through the overlapping openings of the second two rows of openings among the multiple rows of openings and along the length of the pointed portion of the valve leaflet.

16. The method according to any one of claims 13 to 15, wherein extending each side extension portion of the connecting skirt across the second portion of the support column includes covering the inner surface of the second portion of the support column and the vertex of the frame located at the inlet end of the frame with the side extension portion.

17. The method according to any one of claims 13 to 16, wherein fixing each side extension portion to the adjacent side extension portion of the adjacent connecting skirt includes fixing the overlapping portions of the side extension portion and the adjacent side extension portion together via one or more sutures.

18. The method according to any one of claims 13 to 17, further comprising forming the plurality of valve leaflet assemblies, connecting the plurality of valve leaflet assemblies together to form a valve membrane structure, arranging the valve membrane structure inside the frame, and then fixing each connecting skirt to the frame.

19. It is an artificial heart valve, An annular frame having an inlet end and an outlet end, which is radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration, wherein the frame comprises a plurality of support columns, A valve structure mounted within the frame and comprising a plurality of valve leaflets, wherein each valve leaflet comprises opposing tabs on opposing sides of the valve leaflet and a pointed edge portion between the tabs, and each tab pairs with an adjacent tab of an adjacent valve leaflet to form a plurality of commissations connected to the frame, A plurality of connecting skirts, each connecting skirt comprising a base portion connected to each of the corresponding tip portions of the valve leaflets among the plurality of valve leaflets and to a support of the frame, and each connecting skirt further comprising an extension portion extending outward from the tip portion and covering the inner surface of the support of the frame positioned between the tip portions of adjacent valve leaflets, An artificial heart valve comprising: an outer sealing member attached around the outer surface of the frame and fixed to the support column and the plurality of connecting skirts of the frame, wherein the plurality of connecting skirts are attached around the inner surface of the frame; and an outer sealing member.

20. The artificial heart valve according to claim 19, wherein a portion of the support column of the frame, covered by the extension portion of each connecting skirt, forms a vertex at the inlet end of the frame.

21. The artificial heart valve according to claim 19 or claim 20, wherein the base portion of each connecting skirt comprises a central portion and opposing side base portions positioned on both sides of the central portion, and each extension portion of the connecting skirt extends outward from each of the opposing side base portions.

22. An artificial heart valve according to any one of claims 19 to 21, wherein each extension portion of each connecting skirt is attached to an adjacent extension portion of an adjacent connecting skirt, and each extension portion is attached to the adjacent extension portion located within the region of the frame, which is positioned axially with respect to the central longitudinal axis of the frame between a commissure among the plurality of commissures and the inlet end of the frame.

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